WO2018042439A1

WO2018042439A1 - Transcatheter mechanical aortic valve prosthesis

Info

Publication number: WO2018042439A1
Application number: PCT/IL2017/050978
Authority: WO
Inventors: Tanhum Feld; Giorgi SHTENBERG
Original assignee: Corassist Cardiovascular Ltd.
Priority date: 2016-08-31
Filing date: 2017-08-31
Publication date: 2018-03-08

Abstract

The present invention relates to a self-expanding prosthetic valve device and its method of implantation. The valve device comprises: a self-expanding stent, configurable between a collapsed configuration and an expanded configuration; a valve obstructing member comprising a plurality of mechanical leaflets, said valve obstructing member being fixed within the interior of said stent; wherein in the expanded configuration said mechanical leaflets are configured to move between an opened valve state and a closed valve sate.

Description

TRANSCATHETER MECHANICAL AORTIC VALVE PROSTHESIS

FIELD OF THE INVENTION :

The present invention relates to the field of medical instruments. More particularly, the present invention relates to a novel transcatheter mechanical valve with enhanced durability for improving cardiac valve function of patients suffering from valve disease.

BACKGROUND OF THE INVENTION :

The aortic valve lies between the left ventricle and the aorta. When the left ventricle contracts during each heartbeat (systole), pressure rises in the left ventricle. When the pressure in the left ventricle rises above the pressure in the aorta, the aortic valve opens, allowing blood to exit the left ventricle into the aorta. The left ventricle actually pushes blood through three flexible cuplike leaflets which make up the aortic valve. When the left ventricle relaxes (when ventricular systole ends) pressure in the left ventricle rapidly drops and the aortic pressure forces the aortic valve to close. The aortic valve closes and prevents blood from flowing back to the left ventricle .

As people get older, the leaflets may develop deposits of calcium which may cause the leaflets to become thicker and less flexible (e.g. calcific aortic valve stenosis) . In this condition, the leaflets may not fully open, creating a narrowed opening that reduces the amount of blood flowing to the aorta (and thereafter to the body) . The narrowed opening causes a strain in the heart causing the heart to pump harder to supply the blood to the body.

Surgical Aortic Valve Replacement (SAVR) has long been the mainstay of therapy for severe aortic stenosis (AS) or aortic regurgitation (AR) . SAVR is an invasive open heart surgery procedure. The conventional treatment involves resection of the native calcified leaflets, and placement with either a mechanical or a bioprosthetic aortic valve. Mechanical aortic valves offer greater durability, but carry a higher risk of thrombosis and systemic embolism, necessitating systemic anticoagulation. Bioprosthetic valves, by contrast, are subjected to structural degeneration requiring reoperation every 10-15 years (usually in younger patients, <65) .

Currently, nearly one third of severe AS patients deemed of excessive risk for conventional SAVR, and are considered candidates for the relatively new standard of care, Transcatheter Aortic Valve Replacement (TAVR) . TAVR has emerged as an attractive, minimally invasive treatment with improved outcomes over SAVR (i.e., quality-of-life and cost-effectiveness) . However, several critical issues with TAVR remain untreated, e.g., vascular injury, stroke, paravalvular regurgitation, and low valve durability (similar to bioprosthetic valves, limiting its applicability to younger patients).

US 2016/0193045 relates to a prosthetic aortic valve device comprising a stent portion comprising a plurality of elongate members that form an open cylinder defining an interior space and having a distal end and a proximal end, wherein the stent portion is configurable between a collapsed configuration and an expanded configuration, and wherein the stent portion is configured to self-expand from the collapsed configuration to the expanded configuration when the stent portion is caused to emerge from containment within a delivery sheath; and a plurality of leaflets comprising a flexible material, the leaflets having a partially disassembled delivery configuration and an assembled configuration, wherein in the partially disassembled delivery configuration the leaflets are at least partially located outside of the interior space.

WO 2016/138423 relates to an atrioventricular prosthesis device including a frame at least partially defining and enclosing a central cavity, the frame having a distal portion, a proximal portion, and a middle portion connected therebetween. The device further includes a valve construct formed, at least in part, from a cell growth scaffold, at least partially disposed within the central cavity defined by the frame. The valve construct includes: an annular portion defining an aperture and being connected to the frame for positioning the valve construct within the central cavity of the frame, and a plurality of leaflets extending longitudinally and radially inward from the annular portion. The frame and valve construct are transitionable to a deployed state, in which a diameter of at least a portion of the frame and the valve construct substantially conform to a diameter of a tricuspid and/or mitral valve opening. US 7,892,281 relates to a prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

Aortic valves having Bioprosthetic valve leaflets are easier to collapse in a TAVR system, however, they have the aforementioned short comings (e.g. short life duration) . For mechanical aortic valves an invasive SAVR procedure is required. In a TAVR procedure the delivery sheath delivering the valve must be as thin as possible to avoid complications (e.g. injuries during delivery, stroke) . Thus there is a need to substantially collapse as much as possible, the valve within a thin delivery sheath. This task is very difficult to obtain for valves comprising Thus there is an unmet clinical need eliable, transcatheter implantable

It is therefore an object of the present invention to provide a TAVR implantable mechanical valve designed to treat patients suffering from severe aortic valve disease, and a method for delivery thereof.

It is a further object of the present invention to provide means for providing a TAVR implantable mechanical valve with an extended life duration (e.g. designed to treat younger patients suffering from severe aortic valve disease) .

It is yet a further object of the present invention to provide a mechanical valve substantially compressible within a delivery sheath and a method of delivery thereof.

Other objects and advantages of the present invention will become apparent as the description proceeds.

SUMMARY OF THE INVENTION:

The present invention relates to a mechanical transcatheter prosthetic heart valve device configured to be placed at the aortic valve location and replace its function. The prosthetic heart valve comprises a self-expending stent frame and a blood obstructing element fixed within the interior of said stent. The obstructing element comprises a plurality of mechanical leaflets. The leaflets are configured to move from an open state (during systole enabling blood flow through the valve device from the left ventricle to the aorta artery, to a closed state (when ventricular systole ends) wherein pressure in the left ventricle rapidly drops and the aortic negative pressure forces the mechanical leaflets to move radially outwards to obstruct blood flow, preventing blood from flowing back to the left ventricle. The leaflets in the closed state form a substantially flat blockage unit blocking blood flow between the leaflets and the stent (wherein the outer portion of the stent engages the aorta valve) . The leaflets preferably comprise wide portions that engage the stent and engage the base of the obstructing element and thus block blood flow between the leaflets and said base of the obstructing element. Each leaflet wide portions side engages (or closely engages) its adjacent wide portion (in the closed state) adjacent side thus substantially preventing blood flow therebetween.

After systole begins again the pressure in the left ventricle rises again and the blood is pushed out of the left ventricle and causes the mechanical leaflets to move radially inwards thus opening the obstructing element/blockage unit and enabling blood flow through the valve device .

The prosthetic heart valve self-expending stent is configured to have a collapsed configuration during the catheter delivery and an expanded configuration after being deployed in its intended location and position in the aorta valve (the stent in the collapsed configuration has a shorter diameter than that of its diameter in the expanded configuration) . The collapsed configuration is such that enables TAVR minimally invasive catheter delivery of the mechanical valve through a catheter delivery system (e.g. via a sheath assembly suitable for catheter delivery through blood vessels towards the body aorta valve) . After deployment and self-expansion, the expanded configuration enables full function of the mechanical valve where the leaflets are configured to open and close (i.e. be in an open state and closed state respectively) . The mechanical valve device is configured to be operable to transition from the collapsed pre-loaded state to an expanded state by sel f-expanding of the valve to its natural arrangement when deployed and released from the delivery system.

The leaflets in the open state are substantially parallel to the obstructing element central axis and their longitudinal lengths are positioned in the general direction of the blood flow (parallel to the blood flow) . When they move to the closed state they move radially outwards and form the blockage. Preferably, the leaflets are connected to the obstructing element base by a hinge joint. The leaflets are freely movable on the hinge joint and the closed and open states are affected by the blood flow pushing the leaflets radially inwards on the hinge joint to open, and negative pressure retrieving the leaflets radially outwards on the hinge joint to be in the closed blocking state.

Preferably, the obstructing element fixed within the interior of the stent is fixed on reinforcing members connected to the interior of the stent (e.g. elastic tabs) . The stent comprises a general open cylinder shape having an interior space. The stent is aligned such that its central longitudinal axis (the line passing along the center of the cylinder) is in the direction of the blood flow (from the left ventricle to the aorta artery) . Thus the stent has a distal end (e.g. in or towards the left ventricle) and a proximal end (e.g. in or towards the aorta artery) . Preferably the stent is in the form of a mesh. Preferably, the mesh is elastic. The mesh is structured such that it can be collapsed and delivered via catheter delivery system and self-expand towards its natural resting state. The stent resting state is when it is expanded.

The present invention also relates to a method for delivering the valve device as described herein to the aorta valve and deploying it therein so that it could function instead of the body aorta valve leaflets (e.g. if a patient suffers from calcific aortic valve stenosis) . The method comprises delivering the valve device via a catheter delivery system comprising a sheath that reaches the aorta valve. The valve device is deployed out of the sheath when it is placed within the aorta valve and positioned for function .

It should be noted that the present invention valve device can be used for similar purposes in the mitral or tricuspid valves mutatis mutandis (possibly with some adaptations mutatis mutandis) . In the present specification the device is explained with regards to the aorta valve.

The present invention relates to a self-expanding prosthetic valve device comprising: a self-expanding cylindrical mesh stent, configurable between a collapsed configuration and an expanded configuration; reinforcing tabs affixed to the inner side of the stent; a valve obstructing member comprising a base member and a plurality of tiltable mechanical leaflets extending therefrom, said valve obstructing member being fixed to said reinforcing tabs; wherein in the expanded configuration said leaflets are configured to move between an opened valve state and a closed valve sate by tilting radially outwards; and move between a closed state and an open state by tilting radially inwards.

The present invention relates to a self-expanding prosthetic valve device comprising:

a self-expanding stent, configurable between a collapsed configuration and an expanded configuration;

a valve obstructing member comprising a plurality of mechanical leaflets, said valve obstructing member being fixed within the interior of said stent;

wherein in the expanded configuration said mechanical leaflets are configured to move between an opened valve state and a closed valve sate.

Preferably, the stent is in the form of a cylindrical mesh.

Preferably, the stent expanded configuration is in the form of a cylindrical mesh or a substantially venturi structure mesh .

Preferably, the stent mesh is in the form of an array of curved horizontal and curved vertical intersecting members such that the intersection of said members creates a series of cells, wherein each cell is bounded by the intersecting members .

Preferably, the horizontal intersecting members are diagonal in relation to the stent central axis in a first direction and the vertical intersecting members are diagonal in relation to the stent central axis in a second direction .

Preferably, the cells are substantially diamond shaped cells .

Preferably, the curved vertical members are substantially parallel to one another and wherein the curved horizontal members are substantially parallel to one another.

Preferably, the device further comprises reinforcing tabs affixed to the inner side of the stent wherein the obstructing member is fixed to said reinforcing tabs.

Preferably, the obstructing member comprises a base member wherein the mechanical leaflets extend therefrom;

wherein the tabs are attached at one end to the stent inner side and at the other end to said base member.

Preferably, the stent is cylindrical and wherein said stent longitudinal central axis is aligned with the valve obstructing member longitudinal central axis.

Preferably, the tabs are slanted such that said tabs' ends fixed to the stent are at a distal location in relation to the tabs' ends attached to the base member. Preferably, the valve obstructing member comprises a distal cone shaped member on its distal side tapering distally.

Preferably, the obstructing member comprises a base member wherein the mechanical leaflets extend therefrom.

Preferably, the plurality of mechanical leaflets are tiltable, wherein in the expanded configuration the leaflets are configured to move from the opened valve state to the closed valve state by tilting radially outwards, and configured to move from the closed valve state to the opened valve state by tilting radially inwards.

Preferably, each leaflet in the valve device functional opened state surrounds and is substantially aligned parallel to the obstructing member central longitudinal axis .

Preferably, each leaflet in the valve device functional open state is positioned such that it extends from the base member proximally.

Preferably, in the expanded configuration the leaflets are configured to move between the opened state and the closed sate by tilting radially outwards until they engage the stent .

Preferably, the leaflets are connected to the obstructing member base member in a revolute joint manner. Preferably, each leaflet comprises a distal arm connected to the base member, and a proximal wide portion.

Preferably, the wide portion is quadrangular.

Preferably, the wide portion comprises a slight concave shape .

Preferably, in the valve closed state each leaflet wide portion is substantially bounded by two adjacent leaflets' wide portions on its sides, the stent on its proximal edge and the obstructing member base member on its distal edge.

Preferably, in the valve closed state the proximal and distal edges of each leaflet wide portion is curved in a manner configured such that it forms an effective engagement and blockage with the stent and obstructing member base member respectively, and

each side of each leaflet wide portion is configured such that it forms an effective engagement and blockage with its adjacent leaflet wide portion adjacent side.

Preferably, each two adjacent leaflet wide portions have a slanted gap therebetween.

Preferably, the arms comprise apertures at their distal ends, said apertures are in the direction perpendicular to the obstructing member longitudinal central axis.

Preferably, the plurality of leaflets are a plurality of internal leaflets and a plurality of external leaflets; wherein the internal leaflets in the valve opened state surround the obstructing member longitudinal central axis; wherein the external leaflets in the valve open state surround the internal leaflets;

wherein in the valve opened state each two adjacent internal leaflets engage each other at their wide portion sides at a location very near to the central longitudinal axis line of a corresponding external leaflet; and

wherein for every two adjacent leaflets in the closed state one is an internal leaflet and the other is an external leaflet .

Preferably, a plurality of pins, inserted within the apertures, are mounted within the obstructing member base member surrounding the obstructing member longitudinal central axis and perpendicular thereto, such that the leaflets may tilt radially outwards and radially inwards in a revolute joint manner;

wherein said obstructing member base member comprises corresponding slits enabling the leaflet arms to tilt radially outwards and radially inwards within said slit.

Preferably, the obstructing member base member comprises a proximal round fixation cover with a distal side tapering distally attached to a distal round receiving cup with a proximal side tapering distally;

wherein said receiving cup comprises a plurality of elongated recesses on its proximal side surrounding the obstructing member longitudinal central axis and perpendicular thereto;

wherein said fixation cover comprises a plurality of elongated recesses on its distal side surrounding the obstructing member longitudinal central axis and perpendicular thereto;

wherein said fixation cover recesses are placed proximally and parallel to corresponding receiving cup recesses of said receiving cup recesses;

wherein the pins are placed partially within said fixation cover recesses and partially within said corresponding receiving cup recesses.

Preferably, the plurality of leaflets are a plurality of internal leaflets and a plurality of external leaflets;

wherein the internal leaflets in the valve opened state surround the obstructing member longitudinal central axis; wherein the external leaflets in the valve open state surround the internal leaflets;

wherein in the valve opened state each two adjacent internal leaflets engage each other at their wide portion sides at a location very near to the central longitudinal axis line of a corresponding external leaflet;

wherein for every two adjacent leaflets in the closed state one is an internal leaflet and the other is an external leaflet;

wherein the receiving cup recesses comprise a plurality of internal elongated recesses surrounding the obstructing member longitudinal central axis and a plurality of external elongated recesses surrounding said internal recesses ;

wherein the fixation cover recesses comprise a plurality of internal elongated recesses surrounding the obstructing member longitudinal central axis and a plurality of external elongated recesses surrounding said fixation cover internal recesses; wherein said fixation cover internal recesses are placed proximally and parallel to corresponding receiving cup internal recesses of said receiving cup internal recesses; wherein said fixation cover external recesses are placed proximally and parallel to corresponding receiving cup external recesses of said receiving cup external recesses; wherein the pins inserted within said internal leaflets are placed partially within said fixation cover internal recesses and partially within said corresponding receiving cup internal recesses; and

wherein the pins inserted within said external leaflets are placed partially within said fixation cover external recesses and partially within said corresponding receiving cup external recesses.

Preferably, the valve device comprises four internal leaflets and four external leaflets.

Preferably, the valve device in the expanded configuration is configured to be operatively positioned in a body aorta valve ,

wherein the leaflets are in the open state during systole enabling blood flow therethrough from the left ventricle to the body, and are in the closed state when ventricular systole ends and pressure in the left ventricle drops and the aortic negative pressure forces the mechanical leaflets to move radially outwards causing substantial blood obstruction preventing blood from flowing back to the left ventricle . Preferably, the valve device is configured to be passed through a sheath delivery system in the stent collapsed configuration, and

wherein the stent is configured to self-expand from the collapsed configuration to the expanded configuration upon deployment from said sheath delivery system.

Preferably, the pins are fixed to the fixation cover recesses and to the corresponding receiving cup recesses.

Preferably, the stent comprises sinusoidal longitudinal members, wherein each sinusoidal longitudinal member is connected to its adjacent sinusoidal longitudinal member at several corresponding locations such that cells are formed therebetween .

The present invention relates to a method for implanting the valve device as defined herein comprising:

creating an opening in a blood vessel;

inserting an introducer sheath;

inserting a flexible guide wire through the introducer sheath and passing it through the blood vessel all the way to the aorta and through the opening in the aorta valve and into the left ventricle;

passing an inner sheath with said valve device mounted on its distal portion, and an outer sheath with said valve device therewithin, along said guide wire until said device is placed at the aorta valve;

positioning the present invention valve device in the correct intended position; retrieving the outer sheath proximally and deploying said valve device such that it becomes in its expanded configuration;

proximally retrieving the inner sheath and outer sheath; proximally retrieving said guide wire;

removing said introducer sheath.

BRIEF DESCRIPTION OF THE DRAWINGS:

The present invention is illustrated by way of example in the accompanying drawings, in which similar references consistently indicate similar elements and in which:

- Fig. 1A illustrates the mechanical valve in its expanded configuration and functional open state according to an embodiment of the present invention.

- Fig. IB illustrates a side view of the mechanical valve in its expanded configuration and functional open state according to an embodiment of the present invention .

- Fig. 1C illustrates a bottom view of the mechanical valve in its expanded configuration and functional open state according to an embodiment of the present invention .

- Fig. ID illustrates a top view of the mechanical valve in its expanded configuration and functional open state according to an embodiment of the present invention .

- Figs. 1E-1F illustrate cross-section views of the mechanical valve in its expanded configuration and functional open state according to an embodiment of the present invention. - Figure 1G illustrates a layout of laser cutting pattern from which the stent body is cut according to an embodiment of the present invention.

- Fig. 2A illustrates the mechanical valve in its expanded configuration and functional closed state according to an embodiment of the present invention.

- Fig. 2B illustrates a side view of the mechanical valve in its expanded configuration and functional closed state according to an embodiment of the present invention .

- Fig. 2C illustrates a bottom view of the mechanical valve in its expanded configuration and functional closed state according to an embodiment of the present invention .

- Fig. 2D illustrates a top view of the mechanical valve in its expanded configuration and functional closed state according to an embodiment of the present invention .

- Figs. 2E-2F illustrate cross-section views of the mechanical valve in its expanded configuration and functional closed state according to an embodiment of the present invention.

- Figs. 3A-3B illustrate the valve obstructing member in the valve open state according to an embodiment of the present invention.

- Fig. 3C illustrates a cross section of the open state obstructing member according to an embodiment of the present invention.

- Fig. 3D illustrates a top view of the open state obstructing member according to an embodiment of the present invention. - Fig. 3E illustrates the valve obstructing member in the valve closed state according to an embodiment of the present invention.

- Fig. 4A illustrates a single leaflet inner portion side according to an embodiment of the present invention .

- Fig. 4B illustrates a single leaflet outer portion side according to an embodiment of the present invention .

- Fig. 5A illustrates the proximal fixation cover apart from the distal receiving cup and with the plurality of leaflets in the valve open state therebetween, according to an embodiment of the present invention.

- Fig. 5B illustrates the proximal fixation cover apart from the distal receiving cup and with the plurality of leaflets in the valve closed state therebetween, according to an embodiment of the present invention. Fig. 6 illustrates two ad acent leaflet wide portions with a slanted gap therebetween according to an embodiment of the present invention.

- Fig. 7A illustrates the distal receiving cup according to an embodiment of the present invention.

- Fig. 7B illustrates the distal receiving cup with the leaflets therein in the valve closed state according to an embodiment of the present invention.

- Fig. 8A illustrates the proximal side of the proximal fixation cover according to an embodiment of the present invention.

- Fig. 8B illustrates the distal side of the proximal fixation cover according to an embodiment of the present invention. - Fig. 8C illustrates a side view of the proximal fixation cover according to an embodiment of the present invention.

- Fig. 8D illustrates the distal fixation cover with the leaflets therein in the valve open state according to an embodiment of the present invention.

- Figs. 9A-9B illustrate a single leaflet extending out of the obstructing member base in a valve open state and closed state respectively according to an embodiment of the present invention.

- Figs. 9C-9D illustrate a single leaflet in relation to the proximal side of the fixation cover in a valve open state and closed state respectively according to an embodiment of the present invention.

- Figs. 9E-9F illustrate a single leaflet in relation to the distal side of the fixation cover in a valve open state and closed state respectively according to an embodiment of the present invention.

- Figs. 9G-9H illustrate a single leaflet in relation to the proximal side of the receiving cup in a valve open state and closed state respectively according to an embodiment of the present invention.

- Fig. 10A illustrates the collapsed configuration of the valve device according to an embodiment of the present invention.

- Fig. 10B illustrates a top view of the collapsed configuration of the valve device according to an embodiment of the present invention.

- Fig. IOC illustrates a side view of the collapsed configuration of the valve device according to an embodiment of the present invention. - Fig. 10D illustrates a cross-section view of the collapsed configuration of the valve device according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION :

The present invention relates to a mechanical transcatheter prosthetic heart valve configured to be placed at the aortic valve location and replace its function. The prosthetic heart valve comprises a self-expending stent frame and a plurality of mechanical leaflets. The leaflets are configured to move from an open state (during systole enabling blood flow therethrough from the left ventricle to the body) to a closed state (when ventricular systole ends) wherein pressure in the left ventricle rapidly drops and the aortic negative pressure forces the mechanical leaflets to move radially outwards to obstruct blood flow, preventing blood from flowing back to the left ventricle. After systole begins again the pressure in the left ventricle rises again and the blood is pushed out of the left ventricle and causes the mechanical leaflets to move radially inwards thus opening the obstruction and enabling blood flow through the mechanical valve.

The prosthetic heart valve self-expending stent is configured to have a collapsed configuration during delivery and an expanded configuration after being deployed in its intended location and position. The collapsed configuration is such that enables TAVR minimally invasive catheter delivery of the mechanical valve through a sheath delivery system (e.g. via a sheath assembly suitable for catheter delivery through blood vessels or apex (trans- apical) towards the body aorta valve) . After deployment and sel f-expansion, the expanded configuration enables full function of the mechanical valve where the multi-leaflets are configured to open and close. The mechanical valve is configured to be operable to transition from the collapsed pre-loaded state to an expanded state by self-expanding of the valve to its natural arrangement when deployed and released from the delivery system.

In the present specification the "proximal direction" refers to the direction closest to the medical personnel delivering the mechanical valve. The "distal direction" refers to the end furthest from the medical personnel and closest to the target location in the patient's body during delivery of the mechanical valve. Similarly, in relation to the mechanical valve when in place, the "proximal direction" refers to the direction towards the aorta and the "distal direction" refers to the direction towards the left ventricle. Thus, the blood flows from the distal to the proximal direction.

Fig. 1A shows the mechanical valve 10 in its expanded configuration and functional open state enabling blood flow therethrough. The mechanical valve 10 comprises a stent 12 in the form of a cylindrical mesh frame having an interior space. Preferably, the stent 12 mesh comprises a substantially venturi structure, i.e. the structure of a short piece of narrow tube between wider sections (a short tube with a tapering constriction in the middle) . Preferably, the middle longitudinal portion of stent 12 comprises a hyperbolic-like cross section. Optionally, different parts of the stent may have different diameters for an efficient fixation within the aorta valve. The shape of the stent 12 is such that it is configured to be placed in the aortic valve and fixed thereto.

According to a preferred embodiment of the present invention, the cylindrical stent 12 mesh is an array of curved horizontal and curved vertical intersecting members such that the intersection of said members creates a series of cells, wherein each cell is bounded by the intersecting members. More particularly, the horizontal intersecting members are diagonal (in relation to the stent central axis) in a first direction and the vertical intersecting members are diagonal (in relation to the stent central axis) in a second direction. Preferably, the cells are substantially quadrangular cells (e.g. substantially diamond shaped cells) . The curvatures of the intersecting members are such that they form the cylindrical shape (and venturi shape) of the stent 12. According to one embodiment the curved vertical members (or diagonal members in the first direction) and the curved horizontal members (or diagonal members in the second direction) are curved inwards as being part of an oval shape or part of a circular shape. Due to the constriction in the middle of the stent 12 an intersecting member may have more than one curve direction. The curved vertical members (or diagonal members in the first direction) are substantially parallel to one another. The curved horizontal members (or diagonal members in second direction) are substantially parallel to one another.

According to another embodiment of the present invention, the stent comprises sinusoidal longitudinal members, each member connected to its adjacent member at several corresponding locations such that cells are formed therebetween. Figure 1G shows an exemplary embodiment of a layout of laser cutting pattern from which the stent body is cut. A tube is cut according to a certain pattern and its width shape is then set to the required size. According to one example (shown in Fig. 1G) the stent is laser cut from a nitinol tube with 10 mm diameter. After the stent is cut using this pattern it is then shape set to the required diameter, i.e. about 30 mm at the ends and about 20 mm in the middle. This pattern design demonstrates another diamond shape cells configuration that is capable of being crimped into the catheter sheath for delivery. Preferably, the pattern may include the reinforcing tabs (explained hereinafter) .

The mechanical valve 10 comprises a valve obstructing member 15 fixed to reinforcing tabs 16. The reinforcing tabs 16 are affixed to the stent 12. Preferably, the mechanical valve 10 comprises four reinforcing tabs 16 with two opposite pairs facing each other. Thus the obstructing member 15 is well anchored to the tabs.

According to a preferred embodiment, the tabs 16 are fixed at one end to the stent 12 and at the other end to a round portion member 17 of the obstructing member 15 (shown in Fig. IB) . The round portion member 17 has a central axis aligned with the stent longitudinal central axis (and aligned with the valve obstructing member 15 longitudinal central axis) . Preferably, the tabs 16 are slanted such that the tabs' 16 ends fixed to the stent 12 are at a distal location in relation to the tabs' 16 ends attached to the round portion member 17 (wherein the round portion member 17 is placed proximal to the tabs' 16 ends that are fixed to the stent 12) . This configuration contributes to the collapsed stent configuration.

The valve obstructing member 15 is connected to the tabs 16 (e.g. by welding) . The valve obstructing member 15 preferably comprises a distal cone shaped member 20 (shown in Figs. 3A and 3B and 1C) on its distal side tapering distally .

Fig. IB shows a side view of the mechanical valve 10 in its open state. Fig. 1C shows a bottom view of the mechanical valve 10 in its open state and Fig. ID shows a top view of the mechanical valve 10 in its open state.

As the stent 12 is fixed at the aorta valve location, when the mechanical valve 10 is in its functional open state, mechanical valve 10 enables blood to pass therethrough at the areas 13 between the tabs 16, round portion member 17 and stent 12 surface and onto the areas between the stent surface and the opened obstructing member 15. Figs. IE and IF show a cross-section view of the mechanical valve 10 in its open state. Fig IE shows an arrow 14 indicating one flow route of the blood.

The cone shaped member 20 projecting distally contributes to the efficient blood flow (flowing from the distal direction proximally) by directing the blood to pass around the obstructing member 15 main body portion in its open state. The obstructing member 15 comprises a plurality of mechanical leaflets. The leaflets in the mechanical valve 10 functional open state are substantially aligned parallel to the stent 12 central longitudinal axis (wherein the stent 12 central longitudinal axis is the imaginary line along the center of the interior of cylindrical/venturi shaped stent) . Optionally, the leaflets in the open state slightly slant outwards, in any case, allowing blood flow. Thus the blood is able to flow through the stent 12 around the obstructing member 15.

The valve obstructing member 15 in its opened state is shown in Figs 3A-3B. The valve obstructing member 15 in its closed state is shown in Fig. 3E . The valve obstructing member 15 in the valve open state comprises a plurality of leaflets extending proximally from the obstructing member base 25. The leaflets surround the obstructing member 15 longitudinal central axis 19 (the central axis in the distal-proximal direction) . The valve 10 moves into its flow closed state by the leaflets tilting radially outwards, wherein their proximal ends move distant from the central axis 19 until they reach the stent 12 (shown in Figs 2A-2F) , thus causing a substantial complete blockage of the valve 10 preventing blood flow (or almost complete blockage) . The valve 10 moves back into its flow open state by the leaflets tilting radially inwards, wherein their proximal ends move closer to the central axis 19. The leaflet distal ends are fixed to the base 25.

Each leaflet 26 comprises a wide portion 27 (e.g. substantially quadrangular thin plate or tab or flap or strip or flange) attached to an arm 28 as shown in figures 4A-4B. Fig. 4A shows the leaflet 26 inner portion side, i.e. the side closer to the obstructing member 15 central axis 19 (that faces the central axis 19 in the valve open state) . Fig. 4B shows the leaflet 26 outer portion side, i.e. the side farther from the obstructing member 15 central axis 19. The arm 28 portion is connected to the base 25. Fig. 3C shows a cross section of the open obstructing member 15 and Fig. 3D shows a top view of the open obstructing member 15.

According to a preferred embodiment, the wide portion 27 comprises a slight concave shape, i.e. the wide portion inner side 27a comprises a slight concave shaped surface and the wide portion outer side 27b comprises a corresponding similar shaped surface, both facing inwards (thus forming a type of spoon shape) . The arms 28 comprise apertures 28a (or bores) at their distal ends in order to be tiltably mountable on corresponding pins, as will be explained hereinbelow. The apertures 28a (or bores) are in the direction perpendicular to the obstructing member 15 longitudinal central axis 19.

The obstructing member 15 is structured such that in the closed state, each leaflet wide portion 27 is bounded by two of its adjacent leaflets' wide portions on its sides, the stent and the obstructing member base 25, thus causing the blockage. It should be understood to avoid confusion that the valve 10 open state is when the leaflets 26 resemble a closed flower (as in Figs. 1A-1F, 3A-3B) and that the valve 10 closed state is when the leaflets 26 resemble an open flower (when they tilt radially outwards as in Figs. 2A-2F, Fig. 3E).

Fig. 2A shows the mechanical valve 10 in its closed state. Fig. 2B shows a side view of the mechanical valve 10 in its closed state. Fig. 2C shows a bottom view of the mechanical valve 10 in its closed state and Fig. 2D shows a top view of the mechanical valve 10 in its open state. Figs. 2E and 2F show a cross-section view of the mechanical valve 10 in its closed state.

It should be understood herein that when the leaflets 26 tilt radially outwards their proximal ends with their wide portions 27 move distally (on the longitudinal axis) and distant from the central axis 19 (on an axis perpendicular to the longitudinal axis) until they engage the stent 12 inner side. When the leaflets 26 tilt radially inwards their proximal ends with their wide portions 27 move proximally (on the longitudinal axis) and closer to the central axis 19 (on an axis perpendicular to the longitudinal axis) . The leaflet distal ends are fixed to the base 25 at the distal ends of the arms 28 in a manner such that the leaflets 26 are configured to tilt radially outwards/inwards .

According to a preferred embodiment of the present invention, the obstructing member base 25 comprises a proximal fixation cover 40 and a distal receiving cup 30. For illustrative purposes in order to obtain a better understanding of the present invention, Fig. 5A shows the proximal fixation cover 40 apart from the distal receiving cup 30 and with the plurality of leaflets 26 (in the valve open state position) therebetween. Fig. 5B shows the proximal fixation cover 40 apart from the distal receiving cup 30 and with the plurality of leaflets 26 (in the valve closed state position) therebetween. Preferably, the proximal fixation cover 40 and a distal receiving cup 30 are substantially round.

According to a preferred embodiment (e.g. shown in Figs 3A- 3B) the obstructing member 15, when in a valve open state, comprises four internal leaflets 26i (two opposite pairs) surrounding the obstructing member longitudinal central axis 19 wherein each leaflet 26i faces its opposite pair leaflet 26i. The obstructing member 15 when in a valve open state comprises four external leaflets 26e (two opposite pairs) surrounding the internal leaflets 26i (and also the central axis 19 but farther away) wherein each external leaflet 26e faces its opposite pair external leaflet 26e (with portions of internal leaflets therebetween) .

According to a preferred embodiment, during valve open state, each two ad acent internal leaflets engage each other (or almost touch) at their wide portion sides at a location very near to the central longitudinal axis line of a corresponding external leaflet (the location indicated as 22 in top view Fig. 3D) . In other words, the engaging sides (the engaging line) of the internal leaflets are placed near the central (middle) longitudinal line of a corresponding external leaflet (e.g. at a minimum distance of 0.1mm therebetween) . When all of the leaflets move into the valve closed state the leaflets tilt radially outwards and the two adjacent internal leaflets move apart and said corresponding external leaflet is placed (in the valve closed state) therebetween. Thus each two adjacent internal leaflets in the open state are not adjacent in the closed state, but are separated by said corresponding external leaflet therebetween. Similarly, each two adjacent external leaflets in the open state are not adjacent in the closed state, but are separated by a corresponding internal leaflet therebetween. Thus for every two ad acent leaflets in the closed state one is an internal leaflet and the other is an external leaflet.

The obstructing member 15 in its closed state provides a complete (or almost complete) blockage. Each leaflet wide portion in the closed state engages (or almost touches) its two adjacent leaflet wide portions sides. The proximal ends of each leaflet wide portion engage the stent 12 (wherein the stent engages the aorta valve on its outer side) . The distal ends of each leaflet wide portion engage (or almost touch) the obstructing member base 25 circumference (either the proximal fixation cover 40 circumference or the distal receiving cup 30 circumference or the connection line therebetween) . Thus an efficient blockage is formed. The proximal and distal end of each leaflet wide portion is curved (e.g. round) in a manner configured such that it forms an effective engagement (and blockage) with the stent 12 and obstructing member base 25 respectively. The sides of each leaflet wide portion are in a manner configured such that it forms an effective engagement/proximity (and blockage) with its adjacent leaflet wide portions in the valve closed state. According to one embodiment even when the valve is closed the leaflet wide portions are still proximally placed in relation to the leaflet arms.

According to one embodiment of the present invention, the leaflets wide portion sides tightly seal with each other in the closed state (each side with its adjacent side) . Preferably, the proximal edges of the leaflets' wide portions tightly seal (in contact) with the stent 12 inner side in the closed state. Preferably, the distal edges of the leaflets' wide portions tightly seal (in contact) with the base member 25 in the closed state.

According to a preferred embodiment of the present invention (shown in Fig. 6), each two adjacent leaflet wide portions (adjacent in the closed state, e.g. an internal leaflet and an external leaflet), almost touch each other at their sides with a slanted gap 21 therebetween. The side of one leaflet wide portion is slanted wherein its adjacent leaflet wide portion side that it is near to, is also correspondingly slanted. The structure is such that a slanted gap 21 is formed therebetween. The slanted gap 21 elongates the distance for blood to flow from one side of the blockage to the other (in relation to a situation where there would be a non-slanted gap) . This structure contributes to the blood blockage and prevents (or at least delays) blood backflow (e.g. until systole begins again causing valve opening or until a time closer to when systole begins) .

The leaflets are connected to the obstructing member base 25 in a revolute joint manner. A plurality of pins (inserted within apertures 28a) are mounted within the obstructing member base 25 surrounding the obstructing member longitudinal central axis 19 and perpendicular thereto, such that the leaflets may tilt radially outwards and inwards. Corresponding slits in the obstructing member base 25 enable the leaflet arms 28 to tilt radially outwards/inwards within the slit. The distal receiving cup 30 is shown in fig. 7A. According to a preferred embodiment, the round portion member 17 is the circumference of the receiving cup 30. Distal receiving cup 30 has a tapering shape on its proximal side (the most tapered portion being distal to the cup 30 circumference) . The distal receiving cup 30 on its proximal side comprises two opposite pairs of elongated internal recesses 31i surrounding central axis 19 and two opposite pairs of elongated external recesses 31e surrounding central axis 19

(more distant from the center than that of the internal ones) . These recesses are on its proximal side and are perpendicular to central axis 19. A plurality of pins 24

(e.g. shown in Figs. 5A-5B) are inserted within apertures 28a at the arms' 28 distal ends (wherein the apertures are such that the pins 24 inserted therein are substantially parallel to the wide portion distal and proximal edges) . The pins 24 are fixed within recesses 31i and 31e such that each internal leaflet 26i inserted pin 24 is fixed within a corresponding internal recess 31i and each external leaflet 26e inserted pin 24 is fixed within a corresponding external recess 31e. Fig. 7A shows the distal part of the arm motion enabling slits 35. The distal part of the arm motion enabling slits 35 elongate from the recesses 31i and 31e to the receiving cup 30 circumference (naturally the slits extending from the internal recesses 31i are longer that the ones extending from the external recesses 31e) . The internal leaflets are thus longer than the external leaflets. The internal leaflet arms are longer than that of the external leaflet arms. Therefore the longer arm leaflets experience stronger moment force. Therefore the longer arms which are of the inner leaflets move radially first and then those of the shorter outer leaflets. The distal receiving cup 30 comprises a central bore 33 extending from the center of the cup 30 distally. Fig. 7B shows the distal receiving cup 30 with the leaflets 26 therein in the valve closed state. The cone shaped member 20 extends and tappers distally from the distal end of receiving cup 30. The cone is positioned in the middle of the flow direction. It is designed to direct the flow around the obstructing member 15 while creating minimal interference to the flow. The cone angle preferably ranges between 120 to 30 degrees and the radius at the cone end preferably ranges between 0.5 to 5 mm.

The proximal fixation cover 40 is shown in figs. 8A (showing its proximal side), 8B (showing its distal side) and 8C (side view) . The proximal fixation cover 40 has a tapering shape on its distal side (the most tapered portion being distal to the cover 40 circumference) . The proximal fixation cover 40 on its distal side comprises two opposite pairs of elongated internal recesses 41i surrounding central axis 19 and two opposite pairs of elongated external recesses 41e surrounding central axis 19 (more distant from that of the internal ones) . These recesses are on its distal side and are perpendicular to central axis 19. A plurality of pins 24 (e.g. shown in Figs. 5A-5B) are inserted within apertures 28a at the arms' 28 distal ends (wherein the apertures are such that the pins 24 inserted therein are substantially parallel to the wide portion 27 distal and proximal edges) . The pins 24 are fixed within recesses 41i and 41e such that each internal leaflet 26i inserted pin 24 is fixed within a corresponding internal recess 41i and each external leaflet 26e inserted pin 24 is fixed within a corresponding external recess 41e. Fig. 8B shows the proximal part of the arm motion enabling slits 45. The proximal part of the arm motion enabling slits 45 elongate from the recesses 41i and 41e to the fixation cover 40 circumference (naturally the slits extending from the internal recesses 41i are longer that the ones extending from the external recesses 41e) . The fixation cover 40 comprises a central shaft 43 extending distally from its distal side. Fig. 8D shows the distal fixation cover 40 with the leaflets 26 therein in the valve open state .

Preferably, the recesses 41i, 41e, 31i and 31e have a half cylindrical shape.

The obstructing member 15 is structured such that the central shaft 43 of the fixation cover 40 is inserted within central bore 33 of receiving cup 30 and fixed therewithin. The distal side of fixation cover 40 is attached to the proximal side of receiving cup 30. The recesses 41i and 41e are placed proximally and parallel to recesses 31i and 31e respectively and the slit portions 35 and 45 form the full slits (each of the slit portions 35 engages a corresponding slit portion 45) . The pins 24 are fixed to recesses 41i and 41e at their proximal sides and to recesses 31i and 31e at their distal sides. Thus the pins are fixed and the arms 28 may rotate in a revolute joint manner around the pins' axes (while the pins are fixed to the recesses and stationary) . During systole (valve open state) the arms 28 engage the most inner portions of slit portions 45. During valve closed state the arms 28 engage the most outer/distal portions of slits 35. Preferably the arms 28 are freely movable around the joint (radially inwards and radially outwards) and are positioned according to the current state blood flow which causes the leaflets to tilt (i.e. open state during systole and closed state when pressure drops in the left ventricle, e.g. applying negative pressure to the leaflets (suction), sucking them distally.

Optionally, the pins 24 may be an integral part of the arms 28 (or attached thereto within the apertures 28a, e.g. by welding) and rotate within the recesses. Thus the pins along with the arms rotate while the pins are appropriately bounded and held by the recesses. The rotation of the arms (along with the pins) in this case is also substantially around the pins' axes.

For a better illustrative understanding of the present invention, figs. 9A-9H show a single leaflet in a valve open and close state. Figs. 9A-9B show a single leaflet 26 extending out of the obstructing member base 25 in a valve open state and close state respectively. Figs. 9C-9D show a leaflet 26 in relation to the proximal side of the fixation cover 40 in a valve open state and close state respectively. Figs. 9E-9F show a leaflet 26 in relation to the distal side of the fixation cover 40 in a valve open state and close state respectively. Figs. 9G-9H show a leaflet 26 in relation to the proximal side of the receiving cup 30 in a valve open state and close state respectively .

It should be noted that other embodiments of the present invention may include more or less leaflets than as explained hereinabove and in the figures, with corresponding additional/less internal/external leaflets, recesses, and corresponding slits, mutatis mutandis.

The length of the stent is usually between 30 and 100 mm. The diameter of the stent at its distal/proximal ends is usually between 20 and 40 mm. The diameter of the stent (at the constriction in the middle) is usually between 15 and 35 mm. The thickness of the intersecting members is usually between 0.3 and 0.8 mm, preferably 0.5 mm. The width of the intersecting members is usually between 0.15 and 0.5 mm. The stent wall thickness is usually between 0.3 and 0.7 mm, preferably 0.5mm. The constriction size is aimed to have a small diameter, however, the flow cross section at the constriction is preferably larger than 1.2 square cm.

The lengths of the tabs is usually between 5 and 25 mm. The width of the tabs is usually between 0.5 and 5 mm. The thickness of the tabs is usually between 0.3 and 1 mm. The diameter of the round portion member 17 is usually between 5 and 15 mm. The length of the round portion member 17 is usually between 10 and 30 mm.

The length of the leaflets (including the arms along with the wide portions) is usually between 5 and 20 mm. the length of the leaflet wide portion is usually between 3 and 15 mm. The width of the leaflet wide portion is usually between 3 and 10 mm. The thickness of the leaflet wide portion is usually between 0.15 and 1.5 mm. The width of the leaflet arms is usually between 0.15 and 1 mm.

The diameter of the fixation cover is usually between 5 and 15 mm. The length of the fixation cover is usually between 5 and 20 mm. The diameter of the receiving cup is usually between 5 and 15 mm. The length of the receiving cup is usually between 5 and 25 mm. The width of the slit portions are usually between 0.15 and 1 mm.

Gap 21 is usually between 0 and 0.2 mm.

The length of the pins is usually between 1 and 3 mm. The diameter of the pins is usually between 0.5 and 2 mm. The lengths of the recesses (and the diameters of the half cylindrical shaped recesses) in both the fixation cover and in the receiving cup correspond to the pin sizes (preferably slightly larger) .

The stent 12 is configured to be compressed into a collapsed configuration. According to a preferred embodiment, the stent 12 mesh comprises diamond shaped cells and can collapse because the diamond shaped cells can close when the stent is radially crimped (e.g. by use of a stent crimper) . The stent 12 is elastic and self- expandable. In the collapsed configuration the stent 12 is collapsed inward having a cylindrical shape with a shorter diameter than in the expanded configuration. It should be noted that in the expanded configuration the stent is in its normal natural arrangement where it does not collapse or expand. When collapsed the stent 12 is in its pre-loaded state suitable to be delivered in a sheath delivery system (along with the obstructing member and reinforcing members (e.g. tabs) within the interior of the collapsed stent 12 ) . Once the valve 10 is deployed from the sheath delivery system the stent self-expands until the valve 10 becomes in its expanded configuration. In cases with expanded configuration venturi structure, its collapsed configuration also has a cylindrical shape with a diameter smaller than that of the expanded configuration. Preferably, the diameter of the stent 12 in the collapsed configuration is equal (or almost equal) along the whole stent 12 length.

Fig. 10A shows the collapsed configuration of valve 10. Fig. 10B shows a top view of the collapsed configuration of valve 10. Fig. IOC shows a side view of the collapsed configuration of valve 10. Fig. 10D shows a cross-section of the collapsed configuration of valve 10.

When switching from the expanded to the collapsed configuration the stent 12 diameter decreases and the tabs' 16 proximal ends attached to the round portion member 17 move proximally pushing the obstructing member 15 proximally. Thus the obstructing member 15 is more proximal to the distal ends of tabs 16 in the collapsed configuration than that of the expanded configuration. The tabs 16 in this configuration have a diagonal position close to the longitudinal central axis, i.e. close to the distal proximal direction, as shown in Fig. 10D. In any case the whole obstructing member 15 and all its elements are preferably enclosed within the collapsed stent 12 in the collapsed configuration. The stent 12 is capable of contraction and the diamond shape cells (between the intersecting members) can be radially compressed ( elastically) to a crimped shape for insertion into the delivery sheath. The longitudinal angles between the diamond shaped cells (the angles along the longitude of the diamonds placed at the diamond edges in the distal-proximal direction) can be elastically decreased. The stent length can therefore be enlarged. The length of the stent in the collapsed configuration is usually between 2 and 10 percent longer than the stent in the expanded configuration. The diameter of the collapsed stent is usually between 3 and 12 mm.

It should be noted that for a minimal stent diameter in the collapsed configuration, the leaflets 26 are positioned in the open valve state, i.e. wherein the leaflets are substantially parallel to the obstructing member central longitudinal axis.

According to a preferred embodiment of the present invention, the internal leaflets 26i sizes and positions and the external leaflets 26e sizes and positions are such that enable an efficient minimal stent 12 diameter in the collapsed configuration. Preferably, an optimization may be carried out for these sizes/positions. The leaflets are designed in a curved shape to optimally fit in to a minimal catheter diameter. In order for the leaflets to provide the smallest diameter the internal leaflets may have a width size such that they won't collide with each other, the external leaflets may have a width size such that they won't collide with each other and the internal and external leaflets have a width such that they won't collide with one another. All this is said with having a minimal closed state diameter (e.g. where the blocking circle is minimal (minimal radius)) . Also the leaflet slight concave shape portion is such that provides a minimal diameter, and may be a factor in the optimization. The prior art biological leaflets may enable a suitable collapsed configuration within a stent, but have the shortcoming as discussed hereinabove. The present invention special leaflet structure enables an efficient valve collapse with the mechanical leaflets providing a long life span of the valve.

The stent 12 preferably comprises material selected from the group consisting of elastic material, alloyed material polymeric material or any material known used for self- expanding elements. An example of such material is Nitinol .

Optionally, the stent 12 is partially or fully coated with polymer or other relatively soft material, to avoid any degree of regurgitation, at the engagement/contact areas between the leaflets and the stent 12 in the valve closed position .

The valve leaflets (wide portions and arms) preferably comprise material selected from the group consisting of pyrolytic carbon, Titanium, Nickel-Titanium, polymers, polymers reinforced with fibers, metals, carbon deposited on a graphite substrate, pyrolytic carbon which is impregnated with 10 weight % tungsten to provide radiopacity. The pyrolitic carbon is optionally impregnated with material (tungsten) to make it visible by fluoroscopy. The procedure is using fluoroscopy imaging in which heavier materials are more visible. In case of polymers reinforced with fibers, this particularly contributes to the elongated structural durability. Optionally, the leaflets may be flexible . The fixation cover and distal receiving cup preferably comprise material selected from the group consisting of metal and polymer. Optionally, the fixation cover and distal receiving cup comprise material that can be combined with Nitinol, e.g. titanium.

The pins optionally comprise material similar to that of the leaflets. The tabs optionally comprise material similar to that of the stent.

The present invention relates to a TAVR method for delivering the valve device as defined herein to the intended aorta valve location, deploying and correctly positioning the valve device within the aorta valve intended location such that it begins to function replacing the function of the body aorta valve leaflets.

According to an embodiment of the present invention, the delivery system comprises an inner sheath preferably comprising a distal tip (e.g. cone shaped tapering distally) ; a guide wire slidably passing inside the inner sheath, optionally an extra stiff guide wire; the present invention valve device in its collapsed configuration mounted along a distal portion of the inner sheath (wherein the inner sheath is actually placed inside and along the present invention valve device interior) and an outer sheath. Thus, the inner sheath is around the guide wire, the present invention valve device in the collapsed configuration is around the inner sheath, the outer sheath is around the present invention valve device (restraining it from expanding) . It should be noted that the outer sheath keeps the present invention valve device therewithin in the collapsed pre-load configuration. After deployment therefrom, the present invention valve device self-expands to the expanded configuration.

The method comprises the following steps.

Making a skin incision (e.g. in the groin) .

Creating an opening in a blood vessel (e.g. the femoral artery) and inserting an introducer sheath.

Inserting a flexible guide wire through the introducer sheath and passing it through the femoral artery all the way up to the aorta and through the opening in the aorta valve and into the left ventricle. Preferably, the guide wire is placed such that it contours to the inner cavity of the left ventricle.

Passing the delivery catheter (which includes the inner sheath, the present invention valve device thereon and the outer sheath) along the guide wire until the present invention valve device is placed at the aorta valve between the aorta artery and the left ventricle.

Positioning the present invention valve device in the correct intended position prior to deployment.

Retrieving the outer sheath proximally (unsheathing the valve device) thus beginning to deploy the valve. During this stage the inner sheath with the present invention mounted thereon are stationary while the outer sheath moves proximally. Preferably, the proximal end of the present invention valve device stent mesh comprises loops (e.g. loops 50 shown in Fig. 1G) engageable within corresponding protrusions protruding from the inner sheath at a suitable location where the proximal end of the stent is mounted. Thus medical personnel may move the outer sheath distally to re-encapsulate portions of the valve device if a change of valve device position is required. The outer sheath closing on the present invention valve device proximal portion thus pressing on the protrusions and maintaining the valve device from totally deploying or slipping away (due to the loops mounted on the protrusions) . Once the outer sheath is proximally retrieved backwards and passes the protrusions the present invention valve device becomes fully deployed. Naturally, when the outer sheath is retrieved proximally and exposes distal portions of the present invention valve device - these portions expand. After full deployment the entire present invention valve device becomes in its full expanded configuration (engaging the aorta valve) . Other fixation methods may be used to keep the valve device mounted on the inner sheath prior to deployment (e.g. protrusions on the inner sheath that go through corresponding stent cells, protrusions on the inner sheath placed at the proximal end of the stent that prevent the stent from moving proximally) .

Thereafter, the delivery catheter (including the outer and inner sheath therewithin) are proximally retrieved and the guide wire is then proximally retrieved .

Then the introducer sheath is removed and the skin incision is closed with stitches.

Other embodiments may comprise other deployment methods such as casing the valve device within a delivery sheath and pushing and causing the stent portion to deploy from a distal end of a delivery sheath. According to one embodiment, the stent may comprise anchoring elements to anchor on tissue in the intended location .

While some of the embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried into practice with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of a person skilled in the art, without departing from the spirit of the invention, or the scope of the claims .

Claims

CLAIMS :

1. A self-expanding prosthetic valve device comprising:

2. The valve device according to claim 1, wherein the stent is in the form of a cylindrical mesh.

3. The valve device according to claim 1, wherein the stent expanded configuration is in the form of a cylindrical mesh or a substantially venturi structure mesh.

4. The valve device according to any one of claims 2 and 3, wherein the stent mesh is in the form of an array of curved horizontal and curved vertical intersecting members such that the intersection of said members creates a series of cells, wherein each cell is bounded by the intersecting members .

5. The valve device according to claim 4, wherein the horizontal intersecting members are diagonal in relation to the stent central axis in a first direction and the vertical intersecting members are diagonal in relation to the stent central axis in a second direction.

6. The valve device according to claim 5, wherein the cells are substantially diamond shaped cells.

7. The valve device according to claim 5, wherein the curved vertical members are substantially parallel to one another and wherein the curved horizontal members are substantially parallel to one another.

8. The valve device according to claim 1, further comprising reinforcing tabs affixed to the inner side of the stent wherein the obstructing member is fixed to said reinforcing tabs .

9. The valve device according to claim 8, wherein the obstructing member comprises a base member wherein the mechanical leaflets extend therefrom;

10. The valve device according to claim 9, wherein the stent is cylindrical and wherein said stent longitudinal central axis is aligned with the valve obstructing member longitudinal central axis.

11. The valve device according to claim 9, wherein the tabs are slanted such that said tabs' ends fixed to the stent are at a distal location in relation to the tabs' ends attached to the base member.

12. The valve device according to claim 1, wherein the valve obstructing member comprises a distal cone shaped member on its distal side tapering distally.

13. The valve device according to claim 1, wherein the obstructing member comprises a base member wherein the mechanical leaflets extend therefrom.

14. The valve device according to claim 13, wherein the plurality of mechanical leaflets are tiltable, wherein in the expanded configuration the leaflets are configured to move from the opened valve state to the closed valve state by tilting radially outwards, and configured to move from the closed valve state to the opened valve state by tilting radially inwards.

15. The valve device according to claim 14, wherein each leaflet in the valve device functional opened state surrounds and is substantially aligned parallel to the obstructing member central longitudinal axis.

16. The valve device according to claim 14, wherein each leaflet in the valve device functional open state is positioned such that it extends from the base member proximally .

17. The valve device according to claim 14, wherein in the expanded configuration the leaflets are configured to move between the opened state and the closed sate by tilting radially outwards until they engage the stent.

18. The valve device according to claim 14, wherein, the leaflets are connected to the obstructing member base member in a revolute joint manner.

19. The valve device according to claim 14, wherein each leaflet comprises a distal arm connected to the base member, and a proximal wide portion.

20. The valve device according to claim 19, wherein the wide portion is quadrangular.

21. The valve device according to claim 19, wherein the wide portion comprises a slight concave shape.

22. The valve device according to claim 19, wherein in the valve closed state each leaflet wide portion is substantially bounded by two adjacent leaflets' wide portions on its sides, the stent on its proximal edge and the obstructing member base member on its distal edge.

23. The valve device according to claim 22, wherein in the valve closed state the proximal and distal edges of each leaflet wide portion is curved in a manner configured such that it forms an effective engagement and blockage with the stent and obstructing member base member respectively, and each side of each leaflet wide portion is configured such that it forms an effective engagement and blockage with its adjacent leaflet wide portion adjacent side.

24. The valve device according to claim 23, wherein each two adjacent leaflet wide portions have a slanted gap therebetween .

25. The valve device according to claim 19, wherein the arms comprise apertures at their distal ends, said apertures are in the direction perpendicular to the obstructing member longitudinal central axis.

26. The valve device according to claim 25, wherein the plurality of leaflets are a plurality of internal leaflets and a plurality of external leaflets;

27. The valve device according to claim 25, wherein a plurality of pins, inserted within the apertures, are mounted within the obstructing member base member surrounding the obstructing member longitudinal central axis and perpendicular thereto, such that the leaflets may tilt radially outwards and radially inwards in a revolute joint manner;

28. The valve device according to claim 27, wherein the obstructing member base member comprises a proximal round fixation cover with a distal side tapering distally attached to a distal round receiving cup with a proximal side tapering distally;

29. The valve device according to claim 28, wherein the plurality of leaflets are a plurality of internal leaflets and a plurality of external leaflets;

wherein for every two adjacent leaflets in the closed state one is an internal leaflet and the other is an external leaflet; wherein the receiving cup recesses comprise a plurality of internal elongated recesses surrounding the obstructing member longitudinal central axis and a plurality of external elongated recesses surrounding said internal recesses ;

wherein the fixation cover recesses comprise a plurality of internal elongated recesses surrounding the obstructing member longitudinal central axis and a plurality of external elongated recesses surrounding said fixation cover internal recesses;

wherein said fixation cover internal recesses are placed proximally and parallel to corresponding receiving cup internal recesses of said receiving cup internal recesses; wherein said fixation cover external recesses are placed proximally and parallel to corresponding receiving cup external recesses of said receiving cup external recesses; wherein the pins inserted within said internal leaflets are placed partially within said fixation cover internal recesses and partially within said corresponding receiving cup internal recesses; and

30. The valve device according to claim 29, wherein said valve device comprises four internal leaflets and four external leaflets.

31. The valve device according to claim 14, wherein said valve device in the expanded configuration is configured to be operatively positioned in a body aorta valve, wherein the leaflets are in the open state during systole enabling blood flow therethrough from the left ventricle to the body, and are in the closed state when ventricular systole ends and pressure in the left ventricle drops and the aortic negative pressure forces the mechanical leaflets to move radially outwards causing substantial blood obstruction preventing blood from flowing back to the left ventricle .

32. The valve device according to claim 1, wherein said valve device is configured to be passed through a sheath delivery system in the stent collapsed configuration, and wherein the stent is configured to self-expand from the collapsed configuration to the expanded configuration upon deployment from said sheath delivery system.

33. The valve device according to claim 28, wherein the pins are fixed to the fixation cover recesses and to the corresponding receiving cup recesses.

34. The valve device according to claim 3, wherein the stent comprises sinusoidal longitudinal members, wherein each sinusoidal longitudinal member is connected to its adjacent sinusoidal longitudinal member at several corresponding locations such that cells are formed therebetween .

35. A method for implanting the valve device according to claim 1 comprising:

creating an opening in a blood vessel;

inserting an introducer sheath; inserting a flexible guide wire through the introducer sheath and passing it through the blood vessel all the way to the aorta and through the opening in the aorta valve and into the left ventricle;

positioning the valve device in the correct intended position;

retrieving the outer sheath proximally and deploying said valve device such that it becomes in its expanded configuration;

removing said introducer sheath.