WO2025004050A1

WO2025004050A1 - Cardiac anchoring stent, valve system and a method for deploying same

Info

Publication number: WO2025004050A1
Application number: PCT/IL2024/050637
Authority: WO
Inventors: Shira BURG; Elad ELISHA; Amit Tubishevitz
Original assignee: Symbiosis C.M. Ltd
Priority date: 2023-06-28
Filing date: 2024-06-28
Publication date: 2025-01-02
Also published as: IL304130B1; IL304130B2; IL304130A

Abstract

A prosthetic cardiac valve system is disclosed comprising a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and a radially deformable intermediate section extending therebetween. 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. The upstream tissue engaging spikes and the 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, controlled by the inflation of the downstream inflatable tubular element. An upstream elastic sleeve may extend over at least a portion of the upstream mesh section. The upstream elastic sleeve can have an upstream inflatable tubular element disposed axially upstream of the upstream mesh section or downstream of the upstream mech section. A prosthetic cardiac valve can be configured to be secured within the upstream elastic sleeve after the stent is positioned in situ and the upstream inflatable tubular element of the upstream elastic sleeve is inflated. The prosthetic valve leaflets can be integrated as one piece within the prosthetic cardiac valve system.

Description

CARDIAC ANCHORING STENT, VALVE SYSTEM AND A METHOD FOR

DEPLOYING SAME

TECHNOLOGICAL FIELD

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

BACKGROUND ART

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.

References considered to be relevant as background to the presently disclosed subject matter: WO22201158; WO2017151566; US8,556,881; US2022241071; WO2022201158; US2009088836; WO2017151566.

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.

BACKGROUND

WO22201158 discloses a supporting structure for accommodating a prosthetic valve aimed at replacing valve, a prosthetic valve system, a method for sealing between a native tissue and a prosthetic implant, a kit for implanting a prosthetic 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.

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.

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.

GENERAL DESCRIPTION

A first aspect of the disclosure is directed to a support structure for supporting a prosthetic cardiac valve, said 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/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 said upstream mesh section; said upstream elastic sleeve having an upstream inflatable tubular element disposed axially upstream of said upstream mesh section.

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.

The term ‘valve ’ as used herein the specification and claims denotes a prosthetic valve engageable within the elastic sleeve, and configurable as a one-way valve, facilitating blood flow in correspondence with hemodynamics flow directions.

The prosthetic valve is inherent with a carrier stent, wherein a nominal diameter of the stent of the prosthetic valve, at its deployed position, is greater than a nominal diameter of the stent at its deployed position, hence once deployed, the prosthetic valve is engageable within the elastic sleeve.

However, according to another example, the prosthetic valve can be directly secured within the elastic sleeve.

The support structure is configurable 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 closed position the upstream tissue engaging spikes and the downstream tissue engaging spikes are coplanar with an outside surface of the stent.

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 ‘uninflated’ and ‘nominal ’ position refer to the stent at its position at rest, prior to manipulating into its deployed position.

The support structure, at its closed position, can be received within a deploying catheter.

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 a radially deformable 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.

Radially outwardly deformation of the upstream mesh portion and of the downstream mesh section is imparted by an inflatable tubular element associated with the respective mesh portion.

The stent undergoes thermal treatment, whereby it obtains memory shape, so that once introduced into the body and deformed into its operative, expanded position it maintains said memory shape imparted thereto.

The stent is a tubular wire mesh, that 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.

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.

Before deploying the stent into the body, 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 an outside surface of the stent, as per predesigned memory shape thereof.

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 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/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 tubular 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 tubular 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 tubular element of the upstream elastic sleeve and the downstream inflatable tubular element of the downstream elastic sleeve are inflated.

Notably, the term dock is at times used in the art, as referring to a prosthetic cardiac valve support system.

The prosthetic cardiac valve is integrated in some embodiments with the stent. The prosthetic cardiac valve support system can comprise temporary valve leaflets attached to one or more mesh portions of the stent and/or to the upstream elastic sleeve configured. The prosthetic cardiac valve support system can be configured for attachment of the prosthetic cardiac valve by over-riding the temporary valve leaflets of the prosthetic cardiac valve support system, namely, the dock.

According to any of the aspects of the present disclosure, a downstream inflatable tubular element can be configured in association with the downstream mesh section and configured for deploying same radially outwards.

The prosthetic cardiac valve system according to the present disclosure can further be configured with an inflating mechanism for inflating and pressure regulating of the pressure within the upstream inflatable tubular element and the downstream inflatable tubular element). The respective inflating mechanism can be independently associated with each of the upstream inflatable tubular element and the downstream inflatable tubular element.

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 tubular 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 tubular 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 tubular element and the downstream inflatable tubular element.

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:

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;

C. Inflating the downstream inflatable element, while 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, while the guide wire optionally remains in place;

In some embodiments the method further comprises: introducing and guiding a compressed prosthetic valve over the guide wire e.g., with a dedicated delivery system of the prosthetic valve into the prosthetic cardiac valve system; positioning the prosthetic valve within the inflated prosthetic cardiac valve system under imaging, between the upstream inflatable element and the downstream inflatable element; deploying the prosthetic valve; optionally, withdrawing the prosthetic 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.

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.

The method may comprise introducing over the guide wire a compressed insertable prosthetic cardiac valve into the prosthetic cardiac valve system, positioning the compressed insertable prosthetic valve within the inflated prosthetic cardiac valve system e.g., under imaging, deploying the insertable prosthetic valve, withdrawing the prosthetic valve’s capsule.

By a specific configuration, there is disclosed a support structure for supporting a prosthetic mitral valve, said support structure having 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 outside face of the sleeve, the mesh structure having an atrial section and a ventricular portion, with a radially deformable section extending therebetween, and wherein the ventricular portion is configured with a plurality of sub annular tissue engaging spikes, whereby inflating the sub annular inflatable member entails radially outwards deformation of the downstream deformable section and of the radial deformation of the downstream engaging spikes, wherein a prosthetic valve is secured within the elastic sleeve, at the annular level thereof.

According to a particular design, the atrial portion of the mesh is configured with a plurality of supra- annular tissue engaging spikes.

According to an embodiment of any of the disclosed aspects, the support structure can further comprise 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 tubular element axially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.

The support structure is configured for positioning and securing within a cardiac valve cavity wherein at its deployed, expanded position the upstream inflatable tubular element is configured for bearing over the annulus of the native cardiac valve, to thereby seal and prevent blood flow external to the sleeve.

Once the support structure is positioned and secured within a cardiac valve cavity, the stent is allowed to assume its expanded shape and bears against the native commissure, wherein the inflated upstream inflatable tubular element bears over the annulus of the native cardiac valve, and functions as a seal to prevent blood flow external to the sleeve.

The upstream mesh section and a downstream mesh section define between them a flow path in direction from the downstream mesh section to the upstream mesh section, in correspondence with normal hemodynamics, wherein a prosthetic valve is engageable within the elastic sleeve along said flow path.

A prosthetic cardiac valve is securable within the stent, said cardiac valve configurable 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. In the case of a prosthetic cardiac valve support system, a temporary valve is configurable between the upstream and downstream mesh section at a non-deformable section of the support structure, 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 valve within the support structure, said temporary valve is over-ridden by the prosthetic valve. In the case of a prosthetic cardiac valve system, valve leaflets are sutured and/or connected by various methods to the inner stent frame of the prosthetic cardiac valve system.

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:

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

• 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;

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

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

• The upstream mesh section can extend in proximity below the downstream inflatable tubular element;

• the upstream mesh section extends in proximity above the upstream inflatable tubular element;

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

• 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;

• The upstream elastic sleeve and the downstream elastic sleeve can be a homogeneous sleeve or independent sleeves; • The sleeve member can be a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve;

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

• 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;

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

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

• 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.

• The arrangement is such that at a deployed position, when the upstream inflatable tubular 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;

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

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

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

• The support structure is configurable for use as a valve support for a prosthetic pulmonary valve, wherein the upstream inflatable tubular element is configurable for sub-annular inflation; • At an initial, unstressed position, the stent be cylindric;

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

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

• The upstream inflatable tubular element and the downstream inflatable tubular element can each be configured as an annular pocket of the sleeve, accommodating an inflatable annular balloon;

• Each of the upstream inflatable tubular element and the downstream inflatable tubular element can be configured with a one-way inflating valve, including a possibility to deflate as well by various methods, if needed;

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

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

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

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

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

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

• The inflation/deflation valve can be detachable;

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

• The compressed inflation fluid can be a gaseous substance;

• The compressed inflation fluid can be a liquid, such as isotonic, hypertonic, hypotonic, isosmotic, hyperosmotic, hypoosmotic with various degrees of viscosities • The compressed inflation fluid can be a liquid comprising a puncture sealing agent;

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

• 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.

BRIEF DESCRIPTION OF THE DRAWINGS

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:

Fig. 1A 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;

Fig. IB is a side view of Fig. 1A;

Fig. 1C is a top view of Fig. IB;

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

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

Fig. 2A is a perspective view of the stent of Fig. 1A, illustrated at a deployed/expanded position prior to inflation of the downstream inflatable element;

Fig. 2B is a side view of Fig. 2A;

Fig. 2C is a top view of Fig. 2B;

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

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 tubular element deflated;

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

Fig. 4B illustrates the prosthetic cardiac valve support structure of Fig. 4A at a deployed/expanded position, upon inflating both the inflatable tubular elements;

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 tubular elements, however with the inflatable tubular elements deflated;

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

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

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

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

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

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

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;

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

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

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;

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

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

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

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

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

Fig. 10C illustrates the device of Fig. 10A upon inflating the downstream inflatable element;

Fig. 10D illustrates the device of Fig. 10C from a proximal end;

Fig. 10E illustrates the device of Fig. 10C from a distal end;

Fig. HA 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;

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

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

Fig. HD illustrates the system upon inflating the downstream inflatable element (Fig. 10C - 10E);

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;

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

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

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

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;

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;

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

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

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

DETAILED DESCRIPTION OF EMBODIMENTS

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.

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 and deformed into its operative, expanded/nominal position.

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.

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.

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.

The stent 10 is further configured with a radially deformable 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).

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.

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.

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.

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).

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.

Further attention 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.

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).

With further attention 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.

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.

The upstream elastic sleeve 54 comprises an upstream inflatable tubular 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 tubular 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 tubular element 60 is configured with an inflating mechanism (e.g. tubing 64) for inflating and pressure regulating of the pressure within the upstream inflatable tubular element 60. The tubing 64 can be detachable from the inflatable tubular element with a suitable valve 66 (see Fig. 3A) provided. The inflatable tubular 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 tubular element 60 is greater than that of the prosthetic cardiac valve system 50 at its deployed position.

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 tubular 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.

In Fig. 3A the upstream inflatable tubular 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.

Once the upstream inflatable tubular 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).

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.

Similar to the arrangement of Fig. 3A, the upstream elastic sleeve 74 comprises an upstream inflatable tubular element 80 disposed axially beyond the free tips 26 of the stent, wherein the upstream inflatable tubular 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 tubular element 80 is configured with an inflating mechanism (e.g. tubing 84) for inflating and pressure regulating of the pressure within the upstream inflatable tubular element 80. Tubing 84 can be detachable from the inflatable tubular element with a suitable valve 86 (Fig. 4A) provided. The upstream inflatable tubular 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 tubular element 80 radially expands to thereby assume a sealing position over the annulus of the native cardiac valve.

The prosthetic cardiac valve system 70 comprises a unidirectional prosthetic cardiac valve V (Figs. 7A and 7B), that can be an integral part of the prosthetic valve system e.g., by sewing, welding, stitching etc., or it may be inserted separately during the procedure.

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 tubular element 100 disposed axially internally i.e. upstream of the free tips 28 of the stent 10.

The downstream inflatable tubular 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 tubular element 100 is configured with an inflating mechanism (102) for inflating and pressure regulating of the pressure within the downstream inflatable tubular element 100. The inflating arrangement can be common with the upstream inflatable tubular element 80, for simultaneous inflation thereof, or each of the inflatable tubular element 80 and 100 can be fitted with an individual inflating arrangement. As mentioned before, the inflating mechanism can be detachable from the inflatable tubular 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.

In Fig. 4A the prosthetic cardiac valve system 70 is illustrated at an un-inflated, nominal stent position, wherein the upstream inflatable tubular element 80 and the downstream inflatable tubular 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.

The arrangement is such that radially outwardly deforming the upstream mesh portion (e.g., by inflating the upstream inflatable tubular element 80) and the downstream mesh section (e.g., by inflating the downstream inflatable tubular 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 tubular element 80 and/or the downstream inflatable tubular element 100 (shown in Fig. 4B), the prosthetic cardiac valve system 70 becomes arrested within the native cardiac valve, wherein the upstream inflatable tubular 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 tubular element 100 applies radial force on the downstream mesh section 14, resulting in outward deformation of the downstream mesh section 14.

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 tubular element 124, and a downstream elastic sleeve 130 downstream inflatable tubular element 132.

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.

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

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 tubular 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 tubular element 124 and the downstream inflatable tubular element 132 (seen in Fig. 5B), the prosthetic cardiac valve system 120 becomes arrested within the native cardiac valve, wherein the upstream inflatable tubular 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 tubular element 132 applies radial force on the downstream mesh section 14, resulting in outward deformation of the downstream mesh section 14.

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).

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 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 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 valve 141 is deployed within the deployed support structure 145, the insertable prosthetic valve 141 is engaged there within (as shown in Fig. 7D). In the superimposed image of Fig. 7D the insertable prosthetic 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.

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 valve 141 is positioned and anchored within the support structure 145, whereby upon positioning and deploying the insertable prosthetic valve 141, said temporary valve leaflets 148 are over-ridden by the stent cage 143 of the insertable prosthetic valve 141.

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

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 tubular element 152 is inflated with the left atrium LA at a sealing position, and the downstream inflatable tubular element 153 is inflated sub-annularly within the left ventricle LV at a sealing position.

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 tubular element 162 is inflated with the right atrium RA at a sealing position, and the downstream inflatable tubular element 163 is inflated sub-annularly within the right ventricle RV at a sealing position.

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 tubular element 172 is inflated sub annularly at a sealing position, and the downstream inflatable tubular element 173 is inflated supra annularly within the pulmonary artery PA at a sealing position.

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 tubular element 182 is inflated sub annularly at a sealing position.

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, 11A, 11B), visualized under imaging;

B . Distally advancing the guide wire 191 through 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);

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;

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);

E. Unsheathing the upstream inflatable element 124 under imaging (see Fig. HF); F. Inflating the upstream inflatable element 124 (see Fig. 11G);

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;

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

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

M. Detaching the inflation tubes of the inflatable tubular elements (upstream and downstream);

N. Removing the guide wire;

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

In case of a support system, introducing and guiding the compressed insertable prosthetic valve over the guide wire 191 with a dedicated delivery system of the insertable prosthetic valve into the prosthetic cardiac valve system 120;

In case of a support system, positioning the insertable prosthetic valve within the inflated prosthetic cardiac valve system under imaging, between the upstream inflatable element and the downstream inflatable element;

In case of a support system, deploying the insertable prosthetic valve;

Withdrawing the prosthetic valve’s capsule;

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;

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

Removing the guide wire 191.

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

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

C. Distally advancing the inflated upstream inflatable element placing it supra annularly; D'. Unsheathing distal capsule for downstream inflatable element exposure;

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

F'. Withdrawing the capsule;

And the above-described steps L, M N and O.

In case of a support system, inserting a prosthetic valve into a prosthetic valve support system of embodiments can be carried out as follows:

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

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

K. Withdrawing the prosthetic valve's DS;

L. Inflation level adjustment of the inflatable tubular elements (upstream and downstream) for para valvular leaks elimination, performed under echo guidance;

N. Removing the guide wire;

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

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 tubular 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 tubular 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 tubular element 80 and its downstream inflatable tubular element 100 in their inflated states.

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. 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.

Figs. 13A to 13G demonstrates a procedure of implanting a prosthetic cardiac valve according to possible embodiments by transseptal approach (z.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.

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).

Next, as seen in Fig. 13B, the capsule is split to unsheathe the upstream inflatable tubular 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 tubular element 80 is then inflated inside the atrium to assume its radially expanded stated, seen in Fig. 13C. The upstream inflatable tubular 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.

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 tubular 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.

After the stent (10) assumes its expanded state, as shown in Fig. 13F, the downstream inflatable tubular 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.

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.

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 valve (141) for mounting in the prosthetic cardiac valve e.g., using a dedicated delivery system. The prosthetic 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.

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

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.

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.

Figs. 17A to 17D demonstrate a procedure for placing an insertable prosthetic 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 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 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.

Fig. 17B shows the deployment of the insertable prosthetic valve 235 inside the prosthetic cardiac valve support system, and Fig. 17C shows the insertable prosthetic 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.

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 a radially deformable 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; an upstream elastic sleeve extending over at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable tubular element disposed axially upstream of said upstream mesh section; and a prosthetic cardiac valve secured within one or more of the mesh sections of said stent, after said stent is positioned in situ and the upstream and downstream inflatable tubular elements of said upstream and downstream elastic sleeves are inflated.

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

3. The prosthetic cardiac valve system of claim 1, comprising valve leaflets attached to the upstream elastic sleeve and/or one or more of the mesh sections.

4. 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 tubular element is configured for bearing over the annulus of a native cardiac valve, to thereby seal and prevent blood flow external to the sleeve.

5. 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 tubular element bears over the annulus of a native cardiac valve, and functions as a seal to prevent blood flow external to the sleeve.

6. The prosthetic cardiac valve system of claim 5, wherein at the deployed position, when the upstream inflatable tubular 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.

7. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream mesh section and a 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.

8. The prosthetic cardiac valve system according to any one of the preceding claims, wherein a prosthetic cardiac valve is secured within the upstream mesh section of the stent, said 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.

9. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the stent further comprises 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 tubular 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.

10. The prosthetic cardiac valve system of claim 9, wherein the upstream elastic sleeve and the downstream elastic sleeve are a homogeneous sleeve or independent sleeves.

11. The prosthetic cardiac valve system of claim 9 or 10, wherein each of the upstream elastic sleeve and the downstream elastic sleeve are secured to either an inside face of stent, or to an outside face thereof.

12. The prosthetic cardiac valve system of any one of claims 9 to 11, wherein the sleeve member is a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve.

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

14. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is associated with an inflation/deflation port.

15. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is disposed within an annular pouch of the sleeve.

16. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the inflatable tubular element is inflatable with a fluid comprising a puncture sealing agent.

17. The prosthetic cardiac valve system according to any one of claims 9 to 16, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are received within an enveloping portion of the upstream elastic sleeve and a downstream elastic sleeve, respectively.

18. The prosthetic cardiac valve system according to any one of claims 9 to 17, wherein the upstream inflatable tubular element and the downstream inflatable tubular element are configured as an annular pocket of the sleeve, accommodating an inflatable supra and sub-annular balloon.

19. 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.

20. 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.

21. 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.

22. 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 tubular element; the upstream mesh section extends in proximity above the upstream inflatable tubular element.

23. The prosthetic cardiac valve system according to any one of claims 9 to 22, wherein the downstream inflatable tubular element extends opposite at least a portion of the intermediate mesh section and a portion of the downstream mesh section.

24. 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.

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

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

27. 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.

28. 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 elastic sleeve.

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

30. 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 tubular element and the downstream inflatable tubular element.

31. A support structure for supporting a prosthetic cardiac valve, wherein said 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/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 tubular element disposed axially and radially upstream of said upstream mesh section.

32. The support structure of claim 31, 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 closed position the upstream tissue engaging spikes and the downstream tissue engaging spikes are coplanar with an outside surface of the stent.

33. The support structure of claim 31 or 32, 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.

34. The support structure of any one of claims 31 to 33, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic valve in the mitral position, and wherein the upstream inflatable tubular element is configurable for supra-annular positioning and inflating within the left atrium.

35. The support structure of any one of claims 31 to 34, 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 tubular element is configurable for sub-annular positioning and inflation.

36. The support structure of any one of claims 31 to 35, 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 tubular element is configured and operable for supra-annular positioning and inflating within the right atrium.

37. The support structure of any one of claims 31 to 36, 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 tubular element is configurable for sub-annular positioning and inflating within the right ventricle.

38. The support structure of any one of claims 31 to 37, 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 valve within the support structure, said temporary valve is over-ridden by the prosthetic valve.

39. 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 a radially deformable 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.

40. The stent member according to claim 39, wherein at its deployed, expanded position, the stent assumes a frustoconical shape wherein a narrow portion thereof is the upstream section of the stent.

41. The stent member according to claim 39 or 40, wherein the projecting spikes can be equally distributed about a perimeter of the stent.

42. The stent member according to any one of claims 39 to 40, wherein the projecting spikes have a triangle/ teardrop or elongated loop shape.

43. The stent member according to any one of claims 39 to 42, wherein at an initial, unstressed position, the stent is cylindric.

44. A support structure for supporting a prosthetic mitral valve, said support structure having 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 a radially deformable 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 supranuclear portion entails radial deformation of the of annular/supra annular tissue engaging spikes, and inflating the sub annular portion 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.

45. 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/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/outside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable tubular 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 tubular element.

46. The prosthetic cardiac valve kit of claim 45, further comprising an inflating mechanism for inflating one or both of an upstream inflatable tubular element and a downstream inflatable tubular element.

47. The prosthetic cardiac valve kit of claim 45 or 46, further comprising a detachable inflation tube detachably articulated with each of the upstream inflatable tubular element and the downstream inflatable tubular element.

48. 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;

C . inflating the downstream inflatable element, while an upstream inflatable element is still crimped in the capsule;

E. unsheathing the upstream inflatable element under imaging;

F. inflating the upstream inflatable element;

G. withdrawing the capsule.

49. The method of claim 48 further comprising: introducing and guiding a compressed prosthetic valve over the guide wire; positioning the prosthetic valve within the inflated prosthetic cardiac valve system, between the upstream inflatable element and the downstream inflatable element; deploying the prosthetic valve.

50. A method of deploying a prosthetic cardiac valve support system, or a prosthetic cardiac valve 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 a proximal portion of 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 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.