HK1241684A1 - Heart valve prosthesis - Google Patents

Description

Heart valve prosthesis

RELATED APPLICATIONS

This application is a PCT patent application that claims the benefit of priority from U.S. provisional patent application No. 62/080,619 filed on 11/17/2014. The contents of the above-mentioned application are incorporated herein by reference.

Technical field and background of the invention

The present invention, in some embodiments thereof, relates to heart valve supports, more particularly, but not exclusively, to prosthetic heart valve supports for heart valves, and more particularly, but not exclusively, to heart valve prostheses.

The term "frame" is used throughout the specification and is claimed to mean a support for a heart valve. In some embodiments, the heart valve is optionally a fabric attached to the frame, which is designed to act as a heart valve. In some embodiments, the heart valve is optionally a plastic and/or synthetic and/or metal valve.

The mitral and tricuspid valves are unidirectional heart valves that separate the left and right atria from the corresponding heart ventricles, respectively. These valves have different anatomical and physiological structures, with two (mitral) or three (tricuspid) sail-like leaflets connected to the sub-valvular mechanism of ligaments (chordae tendineae) and papillary muscles, forming part of the shape, function and size of the ventricles of the heart.

The heart has four chambers: the right and left atria, and the right and left ventricles. The atria receive the blood and then pump it into the ventricles, which then pump the blood out into the body.

The synchronous pumping action of the left and right sides of the heart constitutes the cardiac cycle. The cycle begins with a period of ventricular relaxation, called ventricular diastole. The cycle ends in a period of ventricular contraction, called the ventricular systole.

The heart has four valves, which should ensure that blood does not flow in the wrong direction during the cardiac cycle: i.e. to ensure that blood does not flow back from the ventricles into the corresponding atria, or from the arteries into the corresponding ventricles. The valve between the left atrium and left ventricle is the mitral valve. The valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve is at the opening of the pulmonary artery. The aortic valve is at the opening of the aorta.

The opening and closing of the heart valve occurs mainly due to the pressure difference. For example, the opening and closing of the mitral valve occurs due to a pressure difference between the left atrium and the left ventricle. During ventricular diastole, when the ventricles relax, backflow of blood from the pulmonary artery vessels into the veins in the left atrium causes the pressure in the atria to exceed the pressure in the ventricles. Thus, the mitral valve opens, allowing blood to enter the ventricle. When the ventricles contract during the ventricular systole, the intraventricular pressure rises above the pressure in the atria and pushes the mitral valve shut.

As mentioned above, these valves feature a plurality of leaflets connected to chordae tendineae and papillary muscles that allow the leaflets to resist the high pressures generated during contraction (pumping) of the left and right ventricles. In a healthy heart, the chordae become taut, preventing the leaflets from being pushed into the left or right atrium and inverted. Prolapse is a term used to describe a condition in which the coaptation edge of each leaflet can initially coapt and close, but then the leaflets rise higher, the edges separate, and the valve leaks. This is usually prevented by contraction of the papillary muscles and by normal length cords. Contraction of the papillary muscles typically occurs simultaneously with contraction of the ventricle and serves to keep healthy valve leaflets tightly closed under peak systolic pressure applied through the ventricle.

Valve dysfunction can be caused by the cords becoming stretched, and in some cases tearing. When the chordae tear, the result is a disheveled leaflet. Also, a normally configured valve may function improperly because the enlargement of the valve annulus pulls the leaflets apart. This state is called dilation of the annulus and usually originates from myocardial failure. Furthermore, the valve may be defective at birth, or due to acquired disease (usually infectious or inflammatory).

Disease of the valve can cause a narrowing (stenosis) or dilation (regurgitation, insufficiency) of the valve, or a combination of those. Surgical treatments for repairing or replacing valves typically include open heart procedures, extracorporeal circulation, and total or partial removal of the diseased valve, if replaced.

Additional background art includes:

U.S. patent 7,381,220 to Macoviak et al;

U.S. patent No. 8,579,964 to Lane et al;

lane et al, U.S. published patent application No. 2014/0052237;

naor, U.S. published patent application No. 2010/0280606;

U.S. published patent application 2010/010017 to Letac et al;

U.S. published patent application numbers 2007/0270943 to Solem et al;

U.S. published patent application numbers 2007/0185571 to Kapadia et al;

U.S. published patent application numbers 2007/0156233 to Kapadia et al;

U.S. published patent application numbers 2006/0058871 to Zakay et al;

U.S. published patent application 2004/0127981A1 to Rahdert et al;

U.S. published patent application numbers 2003/0199975 to Gabbay;

naor's PCT patent application No. IL 2014/050414;

PCT published patent application WO2013/076724 by Vaturi;

lane et al, PCT published patent application WO 2011/137531;

PCT published patent application No. WO 2011/069048 to Chau et al;

PCT published patent application numbers WO 2011/106544 to Tuval et al;

lane et al PCT published patent application Nos. WO 2011/137531;

naor et al, PCT published patent application WO 2010/106438; and

PCT published patent application number WO 2005/027797 to Ersin.

PCT published patent application No. WO 2004/089250 to Realyvasquez et al.

PCT published patent application number WO 2004/030568 to Macoviak et al.

The disclosures of all references mentioned above and throughout this specification, as well as the disclosures of all references mentioned in those references, are hereby incorporated by reference herein.

Disclosure of Invention

The present invention, in some embodiments thereof, relates to a heart valve support, more particularly, but not exclusively, to a prosthetic heart valve support for a mitral valve.

The invention, in some embodiments thereof, also relates to a prosthesis for a heart valve.

In some embodiments, the heart valve support is placed over the patient's native heart valve and is designed to anchor itself in place.

In some embodiments, the prosthetic valve can be one as described in Naor's aforementioned U.S. published patent application No. 2010/0280606 or Naor's aforementioned PCT patent application No. IL 2014/050414.

According to an aspect of some embodiments of the invention there is provided a device for artificial mitral valve support comprising: an expandable frame configured such that at least a portion of the frame is expandable to be larger than a natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus; a pair of commissure posts attached at one end to a frame, the commissure posts configured to extend downstream of the mitral valve annulus through commissures of a natural mitral valve; a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing the posterior leaflet of the natural mitral valve toward the ventricular wall; and a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts.

According to some embodiments of the invention, the support arch comprises a bend for accommodating a papillary muscle.

According to some embodiments of the invention, further comprising a pair of anterior leaflet hooks, each of the pair of anterior leaflet hooks configured to engage chordae attached to the anterior leaflet and pull the anterior leaflet in opposite directions.

According to some embodiments of the invention, further comprising a plurality of anterior leaflet grabbers, each of the plurality of anterior leaflet grabbers comprising one end attached to the frame and one end configured to grab an anterior leaflet of a natural mitral valve.

According to some embodiments of the invention, further comprising a pair of triangular anchors, each of the pair of triangular anchors comprising one end attached to the frame and one end configured to push against the heart valve trigone.

According to some embodiments of the invention, the support arch is configured to be between 2 and 20 millimetres below the annular plane of a natural mitral valve when placed in the natural mitral valve.

According to some embodiments of the invention, the support arch is covered by a sheet of flexible material.

According to some embodiments of the invention, the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and to push the natural mitral valve annulus into the shape of the D-shaped section.

According to some embodiments of the invention, the support arch is configured to be between 5 and 20 millimeters larger than a diameter of the D-shaped section of the frame. According to some embodiments of the invention, the support arch is configured to be between 2 and 20 millimeters from an upstream edge of the D-shaped section of the frame.

According to some embodiments of the invention, the D-shaped section comprises a lumen having lumen walls parallel to the axis of the natural mitral valve annulus.

According to some embodiments of the invention, the lumen wall of the D-shaped section is in a range between 5 mm and 15 mm long.

According to some embodiments of the invention, further comprising a commissure arch attaching the downstream end of a first of the commissure posts to the downstream end of a second of the commissure posts.

According to an aspect of some embodiments of the invention there is provided a method of supporting an artificial mitral valve, comprising: providing a frame for anchoring an artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to be expandable to a diameter greater than the natural mitral valve annulus to prevent downstream displacement of the frame towards the natural mitral valve annulus, the frame further comprising a pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through commissures of the natural mitral valve, a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing a posterior leaflet of the natural mitral valve towards the ventricular wall, and a support arch attaching a downstream end of a first one of the commissure posts to a downstream end of the posterior extension to a downstream end of a second one of the commissure posts; positioning at least a portion of the frame in the left atrium; passing the posterior extension and supporting arch through the natural mitral valve commissures to push against the posterior leaflet of the natural mitral valve toward the ventricular wall; and positioning the commissure posts at the natural mitral valve commissures.

According to some embodiments of the invention, the frame further comprises a pair of hooks, and further comprising engaging a cord attached to the anterior leaflet using each of the pair of hooks.

According to some embodiments of the invention, the frame further comprises an anterior leaflet grabber, the anterior leaflet grabber comprising a plurality of extensions, each of the plurality of extensions comprising one end attached to the frame and one end configured to grasp an anterior leaflet of a natural mitral valve, and further comprising using the anterior leaflet grabber to grasp a natural anterior mitral valve leaflet.

According to some embodiments of the invention, the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and to push the natural mitral valve annulus into the shape of the D-shaped section, and further comprising placing the D-shaped section of the frame at the natural mitral valve annulus.

According to an aspect of some embodiments of the invention there is provided a device for artificial mitral valve support comprising: an expandable frame configured such that at least a portion of the frame is expandable to be larger than a natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus; a pair of commissure posts attached at one end to a frame, the commissure posts configured to extend downstream of the mitral valve annulus through commissures of a natural mitral valve; and an anterior leaflet grabber comprising a plurality of extensions, each of the plurality of extensions comprising one end attached to the frame and one end configured to grab an anterior leaflet of a natural mitral valve.

According to some embodiments of the invention, further comprising a pair of hooks, each of the pair of hooks configured to engage chordae attached to the anterior leaflet and pull the anterior leaflet in opposite directions.

According to some embodiments of the invention, further comprising a posterior extension attached at the first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing the posterior leaflet of the natural mitral valve toward the ventricular wall, and a support arch attaching the downstream end of the first of the commissure posts to the downstream end of the posterior extension to the downstream end of the second of the commissure posts.

According to an aspect of some embodiments of the invention there is provided a method of supporting an artificial mitral valve comprising providing a frame for anchoring an artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to expand larger than the natural mitral valve annulus to prevent displacement of the frame downstream of the natural mitral valve annulus, the frame further comprising a plurality of anterior leaflet grabbers, each of the plurality of anterior leaflet grabbers comprising one end attached to the frame and one end configured to grab an anterior leaflet of the natural mitral valve, and further comprising using the anterior leaflet grabbers to grab a natural anterior mitral valve leaflet.

According to some embodiments of the invention, the frame further comprises a pair of hooks, and further comprising engaging chordae attached to native anterior mitral valve leaflets using each of the pair of hooks.

According to some embodiments of the invention, the frame further comprises: a pair of commissure posts attached at one end to a frame, the commissure posts configured to extend downstream of the mitral valve annulus through commissures of the natural mitral valve, a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, pushing posterior leaflets of the natural mitral valve toward a ventricular wall, and a support arch attaching a downstream end of a first of the commissure posts to a downstream end of the posterior extension to a downstream end of a second of the commissure posts, and further comprising passing the posterior extension and the support arch through the natural mitral valve commissures to push against the posterior leaflets of the natural mitral valve toward the ventricular wall and positioning the commissure posts at the natural mitral valve commissures.

According to some embodiments of the invention, the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and to push the natural mitral valve annulus into the shape of the D-shaped section, and further comprising placing the D-shaped section of the frame at the natural mitral valve annulus.

According to an aspect of some embodiments of the invention there is provided a device for artificial heart valve support, the device comprising: an upstream portion designed to expand to have at least one dimension wider than a native heart valve annulus; a downstream portion attached to the upstream portion, the downstream portion also designed to expand such that at least a portion has at least one dimension wider than the native heart valve annulus; and a plurality of prosthetic valve commissure posts.

According to some embodiments of the invention, the upstream portion and the downstream portion comprise separate components designed to be attached to each other.

According to some embodiments of the invention, the upstream portion is produced from a material selected from the group consisting of a tube, a sheet, and a braided wire.

According to some embodiments of the invention, the downstream portion is produced from a material selected from the group consisting of a tube, a sheet, and a braided wire.

According to some embodiments of the invention, the commissure posts are attached to the downstream portion.

According to some embodiments of the invention, the commissure posts are attached to the upstream portion.

According to some embodiments of the invention, the downstream portion comprises an expandable mesh designed to expand to a diameter greater than the diameter of the native heart valve annulus.

According to some embodiments of the invention, the downstream portion comprises a single ring with a diameter larger than a diameter of the native heart valve annulus.

According to some embodiments of the invention, the downstream portion comprises a single asymmetrically-shaped ring with at least one dimension larger than a diameter of the native heart valve annulus.

According to some embodiments of the invention, the downstream portion further comprises support arcs connecting the commissure posts.

According to some embodiments of the invention, the support arcs are designed to expand against native heart leaflets.

According to some embodiments of the invention, the support arcs are designed to expand such that the downstream portion has a diameter larger than the diameter of the native heart valve annulus.

According to some embodiments of the invention, the commissure posts comprise holes for suturing the flexible sheet material.

According to some embodiments of the invention, the plurality of commissure posts consists of three commissure posts.

According to some embodiments of the invention, the commissure posts extend downstream, then curve outward and are attached to a balcony having a diameter that is larger than the width of the native heart valve annulus, at least in one direction.

According to some embodiments of the invention, further comprising a support bar between the commissure posts.

According to some embodiments of the invention, the support rods extend downstream and then curve outwardly and are attached to a balcony having a diameter that is larger than the width of the native heart valve annulus, at least in one direction.

According to some embodiments of the invention, the upstream portion comprises an expandable mesh, a portion of which is designed to expand to a diameter larger than the diameter of the native heart valve annulus.

According to some embodiments of the invention, the upstream portion comprises a single loop designed to expand to a diameter larger than the diameter of the native heart valve annulus.

According to some embodiments of the invention, the upstream portion comprises a single asymmetrically-shaped ring having at least one dimension greater than a diameter of the native heart valve annulus.

According to some embodiments of the invention, the device further comprises a flexible sheet attached to the commissure posts and designed to act as an artificial heart valve, thereby allowing blood flow from an upstream side to a downstream side of the device and preventing blood flow from the downstream side to the upstream side of the device.

According to some embodiments of the invention, the flexible sheet comprises several flexible sheets designed and attached to each other to form a prosthetic heart valve.

According to some embodiments of the invention, the flexible sheet comprises a woven fabric. According to some embodiments of the invention, the flexible sheet comprises a biocompatible synthetic sheet. According to some embodiments of the invention, the flexible sheet comprises a pericardium tissue sheet.

According to some embodiments of the invention, the flexible sheet is attached to the device and is designed to expand freely until contacting the wall of the native heart.

According to an aspect of some embodiments of the invention, there is provided a method for producing a device for a prosthetic heart valve support, the method comprising producing an upstream portion, producing a downstream portion, and attaching the upstream portion to the downstream portion to produce a frame for the prosthetic heart valve support.

According to some embodiments of the invention, further comprising sewing the flexible sheet to the frame, thereby producing a prosthetic heart valve sewn to the frame.

Unless defined otherwise, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and/or materials are described below. In case of conflict, the present patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be necessarily limiting.

Drawings

Some embodiments of the invention are described herein, by way of example only, with reference to the accompanying drawings and figures. Referring now in detail to the drawings and figures in particular, it is emphasized that the details shown are by way of example and for the purpose of illustratively discussing embodiments of the invention. In this regard, the description taken with the drawings and figures make apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1A is a simplified illustration of an example embodiment of the present invention;

FIGS. 1B and 1C are simplified illustrations of an example embodiment of the present invention;

FIGS. 1D and 1E are top and side view pictures, respectively, depicting an exemplary embodiment of the present invention;

2A, 2B and 2C are pictures depicting the example embodiments of the apparatus of FIGS. 1D and 1E from different perspectives, intended to identify some components of the apparatus;

FIG. 3 is a photograph depicting the example embodiment of the device of FIGS. 1D and 1E, additionally wrapping and supporting an example embodiment of a prosthetic valve with a flexible sheet;

FIG. 4 is a picture depicting an example embodiment of the apparatus of FIGS. 1D and 1E;

FIG. 5 is a picture depicting an example embodiment of the apparatus of FIGS. 1D and 1E;

FIG. 6A is a picture depicting an example embodiment of the apparatus of FIGS. 1D and 1E;

fig. 6B and 6C are pictures depicting an example embodiment of the apparatus of fig. 6A;

FIG. 7 is a picture depicting an example embodiment of the apparatus of FIGS. 1D and 1E;

FIG. 8A is a picture depicting an example embodiment of the present invention;

FIG. 8B is a line drawing of the heart depicting an example location for engaging the crooks of the anterior leaflets of the mitral valve, in accordance with an example embodiment of the invention;

FIG. 9 is a picture depicting the device of FIG. 8A in place within the mitral valve;

FIG. 10 is a picture depicting an example embodiment of the present invention;

FIG. 11 is a picture depicting an example embodiment of the invention in place within the mitral valve;

FIG. 12 is a picture depicting an example embodiment of the invention outside the heart;

FIG. 13 is a flat two-dimensional mechanical diagram of an exemplary embodiment of an apparatus, which is intended to identify some components of the apparatus;

FIG. 14 is a simplified flowchart illustration of a method of supporting an artificial mitral valve according to an example embodiment of the invention;

FIG. 15 is a simplified flowchart illustration of a method of supporting an artificial mitral valve according to other example embodiments of the invention;

FIG. 16 is a simplified illustration of a cross-section of a commissure in a cage according to an example embodiment of the invention;

17A, 17B and 17C are simplified illustrations of a heart valve support according to an example embodiment of the invention;

figure 17D is a cross-sectional side view of the heart valve support in a native heart valve position;

18A, 18B and 18C are simplified illustrations of a heart valve support according to an example embodiment of the invention;

fig. 19A, 19B, 19C and 19D are simplified illustrations of a heart valve support according to an example embodiment of the invention;

figures 20A, 20B and 20C are simplified illustrations of a heart valve support according to an example embodiment of the invention;

21A, 21B and 21C are simplified illustrations of a heart valve support according to an example embodiment of the invention;

22A, 22B and 22C are simplified illustrations of a heart valve support according to an example embodiment of the invention;

FIG. 23 is a simplified illustration of a portion of a heart valve support according to an example embodiment of the invention; and

fig. 24A, 24B and 24C are simplified illustrations of a heart valve support according to an example embodiment of the invention.

Detailed Description

The present invention, in some embodiments thereof, relates to a heart valve support, and more particularly, but not exclusively, to a n-prosthesis heart valve support for a heart valve.

The invention, in some embodiments thereof, also relates to a prosthesis for a heart valve.

In some embodiments, the heart valve support is placed over a native heart valve of a patient. The patient's native heart valve may be defective, allowing some blood to leak back through the native heart valve during the native heart cycle.

Aspects of some embodiments include an expandable stent-like frame that potentially prevents downstream displacement of a heart valve support from an atrium of a heart into a ventricle and/or from the ventricle to the atrium.

In some embodiments, a stent-like, cage-like frame section is provided that is designed to optionally expand wider than the heart valve annulus in order to prevent the frame from shifting downstream of the annulus.

Aspects of some embodiments include a D-shaped section that resembles a healthy native heart valve annulus. In some embodiments, the D-shaped section of the frame is designed to be placed at the heart valve annulus, and optionally to expand against the sides of the annulus. In some embodiments, the D-shaped section is shaped so as to remodel the natural mitral valve into a pre-lesion shape. In some embodiments, the D-shaped section is shaped so as to press against all sides of the native valve annulus and prevent possible blood leaking back from the ventricle to the atrium.

Aspects of some embodiments include an expandable frame made of two parts (an upstream part and a downstream part). In some embodiments, the upstream portion and the downstream portion are manufactured separately and subsequently attached to each other. Such embodiments enable a physician to select a first particular design and/or size of the upstream portion, and to select a particular design and/or size that may be different from the first selection, and decide to attach them to each other to produce the frame.

Aspects of some embodiments include a downstream portion comprising a section designed to expand wider than an annulus of the heart valve in at least one dimension to prevent upstream displacement of the heart valve support under blood pressure. The section designed to be wider is optionally made as follows: a wire extending around the downstream portion; and/or flexible metal sheet cut to form wider sections when expanded; and/or braided wire; and/or a wire in the form of an arc whose end is designed to be pushed against the wall of the heart.

Aspects of some embodiments include an upstream portion comprising a section designed to expand wider than an annulus of the heart valve in at least one dimension to prevent downstream displacement of the heart valve support under blood pressure. The section designed to be wider is optionally made as follows: a wire extending around the upstream portion; and/or flexible metal sheet cut to form wider sections when expanded; and/or braided wire; and/or a wire in the form of an arc.

Aspects of some embodiments include a commissure post attached to the frame at an upstream end and positioned so as to extend downstream through a native heart valve commissure. In some embodiments that include a commissure post, a strut is provided that connects the downstream ends of the commissure posts, potentially also reinforcing the valve support shape and location within the native heart valve.

Aspects of some embodiments include a frame extension that extends under the native valve annulus and pushes the leaflets against the ventricular wall. The frame extensions potentially anchor the heart valve support against reverse upstream displacement from the ventricle into the atrium of the heart.

In some embodiments, the frame extension is attached to the frame at the first end and is shaped to extend downstream of the heart valve annulus. In some embodiments that include commissure posts and frame extensions, a support arch is also provided that connects the downstream end of the frame extension to the downstream end of the commissure posts, potentially also reinforcing the valve support shape and location within the native heart valve, and/or potentially spreading out the back pressure applied on the valve support along the length of the support arch.

In some embodiments above, the heart valve support may be covered with such material in order to prevent blood from entering the atrium from the ventricle.

The terms "native valve" and "native valve annulus" are intended herein to mean a valve or valve annulus that is already present in a patient, as opposed to a prosthetic valve or valve annulus.

In some embodiments, the heart valve support is placed in a heart valve of a patient without suturing the prosthesis to the heart.

In some embodiments, the heart valve support is placed in a heart valve of a patient, and the heart valve support is sutured to the heart.

In some embodiments, the heart valve support is sutured to the heart using fewer individual sutures than would be required for a typical heart valve support, as the heart valve support includes different anchoring extensions as described herein, and the forces acting on the prosthetic valve are potentially less.

In some embodiments, one or more flexible sheets are attached to the frame to form a prosthetic heart valve.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and to the arrangements of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details set forth in the following description or illustrated by way of example. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Reference is now made to fig. 1A, which is a simplified illustration of an example embodiment of the present invention.

Fig. 1A depicts a simplified illustration of an example embodiment of a prosthetic heart valve support 140 for a heart valve. Three parts of the natural heart are depicted in order to show these parts, which will be referred to a number of times in the course of this description.

An upstream portion 132 is depicted, the term upstream being used with respect to the direction of blood flow. By way of non-limiting example, the upstream portion is the left atrium. Ring portion 133 is also depicted. Also depicted is a downstream portion 134-by way of non-limiting example, the downstream portion 134 is the left ventricle.

The example embodiment of the heart valve support 140 is depicted as comprising two general parts:

an upstream portion 142, also known as an onion (onion), which is made with at least some dimensions wider than the ring portion 133 of the native heart, so as to prevent downstream displacement of the heart valve support 140; and

the downstream portion, also called the balcony (balcony), is made with at least some dimensions wider than the ring portion 133 of the natural heart, thereby preventing the heart valve support 140 from being displaced upstream.

The downstream portion of the exemplary embodiment of fig. 1A includes two parts-a balcony rail 143 and a balcony commissure 144, the balcony rail 143 being made to have at least some dimensions wider than the ring portion 133 of the native heart to prevent downstream displacement of the downstream portion, the balcony commissure 144 being made to provide support for the prosthetic heart valve.

In some embodiments, the heart valve support 140 is configured as a combination of three components: onion parts, such as upstream portion 142; a number of commissures in the cage, such as balcony commissures 144, which optionally serve as a skeleton for the prosthetic heart valve; and a balcony portion, such as balcony rails 143, for anchoring and optionally sealing between the heart valve support 140 and the wall and/or annulus of the native heart valve below the native annulus. In some embodiments, the commissures in the cage comprise at least three commissures in the cage, or six, commissures in the cage, or nine commissures in the cage, or more.

It should be noted that many embodiments will be described herein as having three commissure posts, and that these embodiments should be understood as having an integer number of commissure posts, such as two, three, four, five, six, seven, eight, nine, ten, and larger integer numbers.

In some embodiments, commissure posts are used to attach artificial leaflets, which act as artificial valves. In such embodiments, two commissure posts are optionally used to attach two leaflets in a two-leaflet prosthetic valve; three commissure posts are optionally used to attach three leaflets in a tri-leaflet prosthetic valve, and so on.

In some embodiments, the onion parts are larger in diameter, or at least in one dimension, than the native annulus when expanded and prevent the heart valve support 140 from being displaced downstream of the natural mitral valve annulus.

In some embodiments, the onion part size is at least, approximately 10 mm larger than the ring. By way of non-limiting example, for a ring size of 30 mm, the onion part includes an expanded dimension of at least 40 mm. The largest dimension of the onion parts is usually smaller than the atrial diameter. Typical atrial sizes vary from 20-80 mm depending on factors such as reflux, blood pressure, and disease. In some embodiments, the expanded size of the onion parts may be in the range of 35 to 60 mm, and even in the range of 20 to 90 mm. In some embodiments, the onion size can be a diameter of a circle, and in some embodiments, the onion size can be a major dimension of a D-shape, such as when the onion part and/or the heart valve support have a D-shaped cross-section.

In some embodiments, the onion portions are optionally made in the form of an expandable mesh, a stent, and/or in the form of expandable petals.

In some embodiments, the onion is optionally produced from a metal tube cut into a particular expandable shape, a metal sheet cut into a particular expandable shape, and/or a metal wire, and given the shape of the onion as described herein.

The commissures in the cage optionally act as a framework to support the prosthetic valve leaflets. In some embodiments, the commissures in the cage are optionally three commissures positioned 120 degrees apart on a circular plane having a diameter less than the native annulus (see description of fig. 16 below for additional details). The three commissures can alternatively be made in the shape of straight struts, or as tapered struts, wherein the thin portions thereof are directed in the direction of the blood flow.

In some embodiments, the commissure posts are optionally symmetrically distributed around the frame. In some embodiments, the commissure posts are optionally distributed around the frame at locations corresponding to the locations of the native heart valve commissures.

The balcony is optionally configured in such a way that it has a larger diameter than the native ring for a span of at least 100 degrees around the circumference of the heart valve support 140.

Reference is now made to fig. 1B and 1C, which are simplified illustrations of exemplary embodiments of the present invention.

Fig. 1B and 1C are intended to depict a flexible sheet material that acts as a seal between the heart valve support 150 and the ring portion 153 of the native heart against blood leaking back upstream.

Fig. 1B and 1C depict simplified illustrations of an example embodiment of a prosthetic heart valve support 150 for a heart valve.

The example embodiment of the heart valve support 150 is depicted as comprising two general portions:

an upstream portion 151, also referred to as an onion, made with at least some dimension wider than the ring portion 153 of the native heart, to prevent downstream displacement of the heart valve support 150; and

the downstream portion, also called the balcony, is made with at least some dimensions wider than the ring portion 153 of the native heart, thereby preventing the heart valve support 150 from being displaced upstream.

The downstream portion of the exemplary embodiment of fig. 1B and 1C includes: a balcony rail 156 made with at least some dimensions wider than the ring portion 153 of the natural heart, preventing downstream displacement of the downstream portion; and flexible sheets 152, 154 around the heart valve support 150.

Fig. 1B depicts the native heart during the time that blood flows downstream (which is depicted as down the page) or at least that blood does not flow back upstream under pressure relative to the heart valve support 150.

In some embodiments, a portion 154 of the flexible sheets 152, 154 may optionally relax, optionally spanning the span from the inner diameter of the heart valve support 150 toward the balcony rails 156.

In some embodiments, portions 154 of flexible sheets 152, 154 are optionally attached, optionally sutured, to the inner diameter of heart valve support 150. The general plane of the portion 154 of the flexible sheets 152, 154 is optionally approximately parallel to the general plane of the native heart annulus.

Fig. 1C depicts the native heart during the time when blood is regurgitated upstream under pressure relative to the heart valve support 150. The blood exerts a pressure 158 on a portion 154 of the flexible sheets 152, 154, and the portion 154 of the flexible sheets 152, 154 is optionally free to flex against the wall of the native heart and/or against the native heart annulus and prevent blood flow around the heart valve support 150.

In some embodiments, there is a fabric that is sewn at its outside perimeter to the edge of the balcony and to the heart valve support 150 in a manner that allows the fabric between the heart valve support 150 and the balcony to have an area parallel to the native annulus (which is not sewn and is free). The free areas potentially enable the fabric to "bulge" at the free areas and press against the sub-annulus regions of the native heart valve due to blood pressure in the ventricle. This optionally acts as a sealing mechanism such as that depicted in fig. 1C. Such a seal may be better than prior art seals in which the fabric is stitched to the anchoring component along the structure of the anchoring component.

In some embodiments, the flexible sheet comprises a biocompatible synthetic sheet.

In some embodiments, the flexible sheet comprises a sheet of pericardium tissue.

In some embodiments, the flexible sheet comprises a woven fabric, and/or a perforated sheet perforated with small perforations (such as perforations less than 0.1 mm).

Reference is now made to fig. 1D and 1E, which are top and side view pictures, respectively, depicting an exemplary embodiment of the present invention.

Fig. 1D and 1E are intended to illustrate an example embodiment of a device 100 for use on the sides of an artificial heart valve support and identification device 100, which will be referred to throughout this application as the anterior side 102 and the posterior side 104. Fig. 1D is a side view of device 100, and fig. 1E is a bottom view.

Also identified are the entry side (also referred to as atrial side 106) and the exit side (also referred to as ventricular side 108) of the prosthetic heart valve designed to be supported by the prosthetic heart valve support.

Fig. 1D also identifies a location 105 at which location 105, in an example embodiment, device 100 is intended to be approximately at the native heart valve annulus.

Reference is now also made to fig. 2A, 2B and 2C, which are pictures depicting example embodiments of the apparatus 100 of fig. 1D and 1E from different perspectives, intended to identify some components of the apparatus 100.

The components of the example embodiment of the apparatus 100 may include one or more of the following:

a frame 110;

commissure posts 112;

a rear extension 114;

a support arch 116;

a D-shaped frame section 118;

the side ribs 120; and

a commissure arch (122).

In some embodiments, the frame 110 is designed to be larger than the native heart ring diameter, thereby preventing possible displacement of the device 100 downstream into the ventricle.

In some embodiments, commissure posts 112 are attached to frame 110 at locations so as to extend from the atrium into the ventricle at the commissures of the native heart valve.

In some embodiments, the commissure posts 112 also support prosthetic valve leaflets, for example, when the prosthetic valve is a prosthetic valve as described in Naor, U.S. published patent application No. 2010/0280606 and/or in Naor, PCT patent application No. IL 2014/050414. The commissure posts 112 optionally support the valve leaflets along their length.

In some embodiments, three leaflets are used in the prosthetic valve, in which case the posterior extensions 114 also act as commissure posts.

In some embodiments, the posterior extensions 114 are attached to the frame 110 so as to extend from the atrium into the ventricle downstream of the mitral valve annulus and partially reverse and outward, optionally pushing the posterior leaflet of the natural mitral valve towards the ventricular wall.

In some embodiments, the support arch 116 is connected to the downstream end of a first one of the commissure posts 112 to the downstream end of the posterior extension 114 to the downstream end of a second one of the commissure posts 112. The support arch 116 is optionally shaped so as to push the posterior leaflet of the natural mitral valve along the length of the support arch 116 toward the ventricular wall. The support arch 116 spreads out any back pressure on the device 100 along some or all of the length of the support arch 116, thereby reducing the pressure on the ventricular wall tissue.

In some embodiments, the shape of the support arch 116 is contemplated and it accommodates the papillary muscles. This can be seen in fig. 12 described below, where it can be seen that the nipple arch 116 includes a bend that provides a space for accommodating the papillary muscle.

In some embodiments, the D-shaped frame section 118, when placed at the native heart valve annulus, potentially acts to remodel the diseased native heart valve annulus to a healthy shape. In some embodiments, the D-shaped frame section 118 is shaped as a lumen having a length along a central axis of the lumen that is sufficient to enable the D-shaped frame section 118 to seal against the native valve annulus even when the native valve annulus is not perfectly flat and/or when the device 100 is somewhat tilted.

In some embodiments, the D-shaped frame section 118, when placed at the native heart valve annulus, potentially acts to seal the possibility of reverse leakage of blood around the device 100 by pressing against the side of the native heart valve annulus.

In some embodiments, the lateral ribs 120 reinforce and stiffen the device 100, more particularly the commissure posts 112 and the posterior extension 114.

In some embodiments, the commissure arches 122 reinforce and strengthen the device 100, more particularly the commissure posts 112.

Reference is now also made to fig. 3, which is a photograph depicting an example embodiment of the device 100 of fig. 1D and 1E, additionally wrapping and supporting an example embodiment of a prosthetic valve with a flexible sheet.

Fig. 3 is intended to depict an alternative flexible sheet material that assists in sealing the device 100 against possible reverse leakage of blood around the device 100. Fig. 3 is also intended to depict an example embodiment of a bi-leaflet valve constructed of flexible sheet(s).

Fig. 3 depicts: an apparatus 100; a first flexible sheet 302 attached to the outside of the device 100; and a bi-leaflet valve 302 constructed from one or more flexible sheets.

The first flexible sheet 302, which is attached to the outside of the device 100, potentially acts to seal the possibility of blood leaking back around the device 100.

The bi-leaflet valve 304 is an exemplary embodiment of a possible valve for use as a prosthetic heart valve, which is supported by embodiments of the heart valve support device 100.

In some embodiments, the flexible sheet is a sheet of biocompatible material. In some embodiments, the flexible sheet is a sheet of pericardium.

Reference is now also made to fig. 4, which is a picture depicting an example embodiment of the apparatus 100 of fig. 1D and 1E.

Fig. 4 is intended to depict the supporting arch 116, also depicted in fig. 2B and 2C, from a perspective that emphasizes the supporting arch 116.

In some embodiments, the support arch 116 is an extension to the frame 110 of fig. 2A, optionally constructed of 3 legs (two commissure posts 112 and rear extension 114) joined by two arcuate segments.

Together, the support arch 116 forms an open C-shape, optionally larger in diameter than the prosthetic heart valve supported by the device 100. In some embodiments, the distance between the inlet portion of the prosthetic heart valve and the outlet portion of the prosthetic heart valve is approximately the length of the native annulus.

Reference is now also made to fig. 5, which is a picture depicting an example embodiment of the apparatus 100 of fig. 1D and 1E.

Fig. 5 is intended to depict the supporting arch 116 also depicted in fig. 2B and 2C from a perspective that emphasizes the spatial relationship of the supporting arch 116 to the approximate location 502 of the native annulus.

In some embodiments, the arch is located 5-15 mm from the approximate location 502 of the native annulus toward the exit side (reference 504).

In some embodiments, the front side of the support arch 116 is open. The supporting arch 116 optionally causes the heart anatomy to form a "step" under the native annulus on one side of the ventricle. Optionally, a supporting arch 116 is anchored into the step, which can spread the forces potentially induced on the device 100 by blood pressure. Upon spreading the force, the pressure is reduced and the chance of puncturing or abrading the anatomy by the device 100 is potentially reduced.

Reference is now also made to fig. 6A, which is a picture depicting an example embodiment of the apparatus 100 of fig. 1D and 1E.

Fig. 6A is intended to depict the D-shaped frame section 118 from a perspective that emphasizes the D-shaped frame section 118, also depicted in fig. 2A, 2B, and 2C.

In some embodiments, particularly when used in the mitral valve, the D-shaped frame section 118 is optionally used to remodel the native mitral valve annulus. Remodeling optionally brings the native mitral valve annulus close to its healthy shape. The D-shaped frame section 118 potentially enables sealing of the device 100 against the native annulus. The straight side of the D-shape potentially achieves sealing without pushing the native anterior leaflet out into the path of blood from the ventricle to the aorta (which may result in complete or partial occlusion of the aorta).

Reference is now also made to fig. 6B and 6C, which are pictures depicting an example embodiment of the apparatus 100 of fig. 6A.

Fig. 6B is a top view, which is intended to depict the D-shaped frame section 118 from a perspective that emphasizes the straight portion 602 in the D-shaped frame section 118. Fig. 6C shows the same view as fig. 6A and is intended to identify the D-shaped frame section 118.

In some embodiments, the D-shaped frame section 118 includes an extension of the "D" shape into the outlet portion on one side and into the inlet portion on the other side. One purpose of this nearly flat area continues the "D" seal. It is believed that the seal is achieved by holding the flat portion of the D-shaped frame section 118 against the flat "aortic-mitral prolongation" portion of the annulus of the mitral valve. By virtue of the length of the lumen of the D-shaped frame section 118, a seal can be maintained even if the device 100 has been tilted or simply positioned in a generally proper position.

Another purpose of the semi-flat D-shaped design is to prevent the native anatomy on either the atrial or ventricular side from pushing the D-shaped frame section 118 and changing its location within the mitral valve.

Reference is now also made to fig. 7, which is a picture depicting an example embodiment of the apparatus 100 of fig. 1D and 1E.

Fig. 7 is intended to depict the side ribs 120, also depicted in fig. 2A, from the perspective of emphasizing the side ribs 120.

In some embodiments, the side ribs 120 are triangular struts that stretch between the commissure posts 112 and the posterior extensions 114. In some embodiments, the side ribs 120 are positioned toward the exit portion of the device 100. One function of the lateral ribs 120 is to reinforce the commissure posts 112 and the posterior extension 114. The secondary function of the lateral ribs 120 is to help stabilize the device 100 and increase support to the anatomy of the heart.

Reference is now also made to fig. 8A, which is a picture depicting an example embodiment of the present invention.

Fig. 8A is intended to depict optional hooks 802 and anterior leaflet grabbers 804 attached to a device 800 for prosthetic heart valve support.

Fig. 8A depicts a frame 810.

In some embodiments, the hook 802 is optionally attached to the frame 810 proximate to the location of the straight portion of the D-shaped section.

In some embodiments, the hook 802 optionally serves as a triangular anchor. In such embodiments, the hooks 802 are optionally embedded in a portion of the heart anatomy called the trigone, and optionally serve as an anchored portion of the device 800 within the mitral valve.

In some embodiments, the hooks 802 optionally serve as anterior leaflet hooks, each of which is configured to engage chordae connected to the native anterior leaflet and pull the anterior leaflet in the opposite direction.

In some embodiments, the leading leaflet grabber 804 is attached to the apparatus 800, optionally along a straight portion of the D-shaped section.

In some embodiments, the front leaflet grabber 804 is an optionally folded strut, such as included in a stent-like frame 810; optionally, the native anterior leaflet of the mitral valve is captured by the folding struts (anterior leaflet grabbers 804) and optionally pulled and folded to the straight portion of the D-shaped section. In some embodiments, the anterior leaflet cables are pulled by anterior leaflet grips 804. In some embodiments, grasping of the anterior leaflet provides an additional anchoring mechanism of the device 800 to the heart anatomy. In some embodiments, the grasping of the anterior leaflet potentially keeps the anterior leaflet from impeding blood flow toward the aorta.

Reference is now made to fig. 8B, which is a line drawing of the heart depicting an example location for a hook to engage the anterior leaflet of the mitral valve, in accordance with an example embodiment of the invention.

Fig. 8B depicts a possible location 812 for the hook 802 of fig. 8A to grasp the anterior leaflet and stretch the leaflet.

Referring now also to fig. 9, which is a picture depicting the device 800 of fig. 8A in place within the mitral valve.

It should be noted that this picture is of a pig's heart, which also has valves similar to the human mitral and aortic valves.

Fig. 9 is intended to depict the hook 802 and the anterior leaflet grabber 804 with respect to the heart. Fig. 9 depicts a photograph taken through an incision in the right ventricle and through the septum, showing the left ventricle with an implant device 800.

Circle 806 marks a location in the heart called the trigone. The hook 802 anchors the device.

The anterior leaflet 808 is depicted as being captured within a folding strut, referred to herein as the anterior leaflet grab 804.

Fig. 9 depicts device 800 positioned within a native valve, showing anterior leaflet grabber 804 lifting the anterior leaflet of the native valve, thus sweeping away LVOT for blood flow.

Reference is now also made to fig. 10, which is a picture depicting an example embodiment of the present invention.

Fig. 10 is intended to depict an anterior leaflet grabber 1004 attached to a device 1000 for prosthetic heart valve support.

Fig. 10 depicts device 1000, frame 1010, and anterior leaflet grabber 1004 attached to device 1000.

Fig. 10 depicts the device 1000 from a direction that would show the aorta behind the anterior leaflet grabber, being the heart depicted in fig. 10. The anterior leaflet graspers, when covered with pericardial membrane, may prevent blood flow from the left ventricle to the aorta. In fig. 10, the anterior leaflet grasper is folded and allows free blood flow from the left ventricle to the aorta. Fig. 10 shows line 1006 following the folded strut of the anterior leaflet grabber relative to a second line 1008 showing the strut unfolded. It should be noted that the use of folded struts for the anterior leaflet grasper rather than unfolded struts potentially results in open (open) blood flow to the aorta.

As described above with reference to fig. 9, hooks 802 and anterior leaflet grabber 804 hold the anterior leaflet and pull it against the anterior side of frame 810 and optional pericardial skirt. This potentially results in a seal of the anterior region of the device to the native mitral valve interface.

Reference is now also made to fig. 11, which is a picture depicting an example embodiment of the invention in place within the mitral valve.

Fig. 11 is intended to depict the posterior extension 114 and support arch 116 of, for example, fig. 2A, 2B, and 2C with respect to the heart. Fig. 11 depicts a photograph taken from the apex of the left ventricle toward the mitral valve, showing the left ventricle with the implanted device 100.

Fig. 11 depicts a posterior extension 114 extending between papillary muscles of the heart.

Fig. 11 also depicts a supporting arch 116, optionally covered by a flexible sheet, positioned against the wall of the left ventricle. The support arch 116 is depicted as assisting in anchoring the device 100 in the heart and assisting in sealing against leakage of blood between the device 100 and the heart.

A support arch 116 connects commissure posts 112 with rear extension 114. The diameter of the support arch 116 is optionally larger than the diameter of the native mitral ring. During systole, blood pressure pushes device 100 upward toward the atrium. In such embodiments where the supporting arch 116 diameter is greater than the diameter of the native mitral annulus, the supporting arch 116 is pushed against the left ventricular wall and assists in anchoring the device 100. In addition, the force pushing the support arch 116 against the left ventricular tissue results in a potential seal against leakage.

Reference is now also made to fig. 12, which is a picture depicting an example embodiment of the invention outside the heart.

Fig. 12 is intended to depict the posterior extension 114 and support arch 116 of, for example, fig. 2A, 2B, and 2C from a perspective that emphasizes the posterior extension 114 and support arch 116.

Reference is now also made to fig. 13, which is a flat two-dimensional mechanical diagram of an exemplary embodiment of the apparatus 100, which is intended to identify some components of the apparatus 100.

FIG. 13 depicts a frame 110; commissure posts 112; a rear extension 114; a support arch 116; a D-shaped frame section 118; the side ribs 120; and a commissure arch (122).

Reference is now also made to fig. 14, which is a simplified flowchart illustration of a method of supporting an artificial mitral valve, according to an example embodiment of the invention.

The method illustrated by fig. 14 includes:

providing a frame for anchoring an artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to be expandable to a diameter greater than the natural mitral valve annulus to prevent displacement of the frame downstream of the natural mitral valve annulus (1402),

the frame includes:

a pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through the commissures of the natural mitral valve;

a posterior extension attached to the frame at the first end, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing the posterior leaflet of the natural mitral valve toward the ventricular wall; and

a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts,

placing at least a portion of the frame in the left atrium (1404);

passing the posterior extension and supporting arch through the natural mitral valve commissures to push against the posterior leaflet of the natural mitral valve toward the ventricular wall (1406); and

the commissure posts are positioned at the natural mitral valve commissures (1408).

Reference is now also made to fig. 15, which is a simplified flowchart illustration of a method of supporting an artificial mitral valve, according to another example embodiment of the invention.

The method illustrated by fig. 15 includes:

providing a frame for anchoring an artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to expand larger than the natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus (1502); the frame further comprises anterior leaflet grabbers, each of the plurality of anterior leaflet grabbers comprising one end attached to the frame and one end configured to grab an anterior leaflet of a natural mitral valve,

an anterior leaflet grasper is used to grasp a natural anterior mitral valve leaflet (1504).

Reference is now made to fig. 16, which is a simplified illustration of a cross-section of a commissure in a cage according to an example embodiment of the invention.

Fig. 16 depicts a cross section of a heart valve support 1601, the heart valve support 1601 being similar to the heart valve support 140 of fig. 1A, with three prosthetic valve supports 1602, referred to herein as commissures 1602 or balcony commissures 1602. The commissures 1602 should not be confused with the commissures of the native heart valve, as they are part of the artificial heart valve support 1601.

The three commissures may act as a skeleton to hold and support the prosthetic valve leaflet. The commissures are optionally positioned at 120 degrees apart angle on a plane of the section of the heart valve support 1601 having a diameter smaller than the diameter of the native heart valve annulus. The three commissures may alternatively be made as straight struts or tapered struts, wherein the thin portions thereof are directed in the direction of the blood flow.

Reference is now made to fig. 17A, 17B and 17C, which are simplified illustrations of a cardiac valve support 1700 according to an example embodiment of the invention.

Fig. 17A is an isometric view of a heart valve support 1700, fig. 17B is a side view of the heart valve support 1700, and fig. 17C is another, vertical side view of the heart valve support 1700.

Fig. 17A-17C depict an example embodiment having: a valve configuration on the upstream portion 1702 of the cardiac valve support 1700; three artificial commissures 1704 for attaching an artificial heart valve; three strut supports 1706 located between the three commissures 1704; and two layers of arcs 1708 between the commissures 1704 and the strut supports 1706, which also optionally serve as an anchored downstream portion, also referred to as a balcony.

In some embodiments, the upstream portion 1702 resembles a "D" shaped design as described above, potentially enabling free flow of blood through the heart valve.

In some embodiments, the arcs 1708 optionally extend radially outward from the longitudinal axis of the heart valve support 1700 so as to span a diameter larger than the diameter of the native heart valve annulus.

In some embodiments, the arcs 1708 optionally serve to anchor the heart valve support 1700 and/or seal the heart valve support 1700 against blood flow upstream around the heart valve support 1700.

In the configuration depicted in fig. 17, the atrial portion or onion may be mesh-like, or stent-like, and/or shaped as a petal. There are optionally six rods, three of which optionally act as commissures 1704, so as to reinforce a cage that supports the three commissures 1704. In some embodiments, the arcs 1708 of the support commissures 1704 curve outward to potentially act as an anchoring mechanism and/or a sealing mechanism.

Reference is now made to fig. 17D, which is a cross-sectional side view of the heart valve support 1700 in place in the native heart valve 1712.

Fig. 17D depicts a sealing mechanism implemented by native leaflets 1710, the native leaflets 1710 being pushed apart and optionally folded around the arcs 1708. The anchoring mechanism may also be achieved by the arcs 1708, the arcs 1708 pressing on the heart (ventricle) wall, optionally through the native leaflets 1710, and possibly preventing the heart valve support 1700 from being displaced upstream of the native heart valve 1712.

Reference is now made to fig. 18A, 18B and 18C, which are simplified illustrations of a heart valve support 1800, according to an example embodiment of the invention.

Fig. 18A is an isometric view of a heart valve support 1800, fig. 18B is a side view of the heart valve support 1800, and fig. 18C is another, vertical side view of the heart valve support 1800.

18A-18C depict an example embodiment having: an upstream (also referred to as onion) portion 1802 of the heart valve support 1800; three artificial commissure posts 1804 for attaching an artificial heart valve; three strut supports 1806 located between the three commissures 1804; an arc 1810; and a balcony 1808 for anchoring the heart valve support 1800 against upstream displacement.

Fig. 18A-18C depict an embodiment in which the arcs 1810 do not extend further outward than the balcony 1808 and therefore do not serve as an anchoring mechanism. The commissure posts 1804 and/or the strut supports 1806 are made longer and curve outward and upward toward the upstream portion 1802 to form a support for the balcony 1808. In some embodiments, the commissure posts 1804 and/or the strut supports 1806 are optionally curved and optionally angled back inward, potentially reducing the overall diameter of the heart valve support 1800 that can be folded, potentially facilitating insertion via a catheter.

Reference is now made to fig. 19A, 19B, 19C and 19D, which are simplified illustrations of a heart valve support according to an example embodiment of the invention.

Figure 19A is a side view of a heart valve support and figure 19B is an isometric view of an upstream, onion, portion 1902 of the heart valve support.

Fig. 19C is an isometric view of a heart valve support, and fig. 19D is a side view of a downstream, balcony, portion 1904 of the heart valve support.

Fig. 19A-19D illustrate possible options for all embodiments described in this application, where the upstream portion 1902 and the downstream portion 1904 are produced at least initially separately from each other. The two portions may optionally be attached to each other prior to insertion into a patient, and having two portions potentially enables the generation of different heart valve supports, which may comprise different types of upstream and downstream portions as depicted within the present application. The two parts may optionally be attached to each other by welding, such as electric and/or laser welding, or by sewing together (similar to the sewing of a flexible sheet to the heart valve support). Additional methods of attaching the two parts include crimping and/or clamping the tube and/or folding a material such as metal around a mating section such as a rod in the two parts, and/or inserting a pin into a designated hole in the mating section and welding or pinning the parts.

Fig. 19A and 19B depict a configuration in which the upstream portion 1902 (onion portion) is made in the form of a mesh. In some embodiments, the mesh may optionally be made with different cell densities in order to control (i.e., decrease or increase) the stiffness of the onion. In some embodiments, the onion optionally includes three rods on its downstream side, which can act as commissure rods 1908, or to connect the upstream portion 1902 to the downstream portion 1904. In some embodiments, the three commissure posts optionally include three more posts between the commissure posts, optionally to support the commissure posts.

In some embodiments, the downstream portion 1904 (the balcony) is optionally constructed as a separate component, optionally having a mesh design, and optionally connected to the upstream portion 1902 (the onion) via stitches/welds/otherwise, in order to construct the entire heart valve support.

Fig. 19C and 19D depict an example embodiment downstream portion 1904 with three commissure posts 1910 and three arches 1912.

In some embodiments, the upstream portion 1902 or onion is optionally stent-like, optionally made of a metal mesh, optionally a shape-memory mesh.

In some embodiments, downstream portion 1904 optionally includes three commissure posts 1910 and an arch 1912 spanning between commissure posts 1910.

In some embodiments, the downstream portion 1904 includes a distribution of struts 1914, the top of which depicts a line that mimics the function of the balcony 1808 of fig. 18A-C. In such embodiments, the struts 1914 perform a sealing function similar to that of the balcony 1808, and/or potentially provide an anchoring mechanism, using the tips of the struts 1914 to push against the sides of the heart.

In some embodiments, the strut 1914 design enables a thinner profile (profile) of the heart valve support when folded into a tube, such as a catheter, for delivery into the heart.

Reference is now made to fig. 20A, 20B and 20C, which are simplified illustrations of a heart valve support according to an example embodiment of the invention.

Fig. 20A is an isometric view of a heart valve support 2000, and fig. 20B and 20C are side views of the heart valve support 2000 from different angles.

Fig. 20A, 20B and 20C depict a configuration of the heart valve support 2000 with an upstream portion 2004 (onion) and a downstream portion 2002.

In some embodiments, the upstream portion 2004 or onion is optionally stent-like, optionally made of a metal mesh, optionally a shape-memory mesh.

In some embodiments, the downstream portion 2002 optionally includes three commissure posts 2006 and an arch 2008 spanning between the commissure posts 2006.

Reference is now made to fig. 21A, 21B and 21C, which are simplified illustrations of a heart valve support 2100, according to an example embodiment of the invention.

Fig. 21A is a side view of the heart valve support 2100, and fig. 21B is an isometric view of the heart valve support 2100, and fig. 21C is an isometric view of the downstream portion 2104 of the heart valve support 2100.

In some embodiments, an upstream portion 2102 (onion) similar to the onion embodiment depicted in fig. 20 and a downstream portion 2104 such as the embodiment depicted in fig. 21C form the heart valve support 2100 depicted in fig. 21A and 21B.

The downstream portion 2104 depicted in fig. 21A, 21B, and 21C is optionally made from a metal sheet cut to the design and shape for the boss portion, or downstream portion 2104. In some embodiments, making the male portion 2104 from sheet metal rather than a metal tube potentially enables a more continuous line of contact with the surrounding sub-ring tissue for better sealing.

Reference is now made to fig. 22A, 22B, and 22C, which are simplified illustrations of a heart valve support 2200, according to an example embodiment of the invention.

Fig. 22A and 22B are side views from different angles of the heart valve support 2200, and fig. 22C is an isometric view of the heart valve support 2100.

Fig. 22A, 22B, and 22C depict an upstream portion 2202 (also referred to as an onion portion) and a downstream portion 2204 (also referred to as a balcony portion). Fig. 22A, 22B, and 22C depict three commissure posts 2208 and support arcs 2206.

In some embodiments, upstream portions 2202 (similar to downstream portions 2204) are optionally attached to each other at commissure posts 2208 to create a heart valve support 2200.

In some embodiments, additional rods are added between each commissure post 2208 to strengthen the present embodiment against cardiac contraction.

In some embodiments, the downstream portion 2204 and/or the upstream portion 2202 is optionally made from sheet metal cut into a design and shape for the land, or downstream portion 2204 and/or upstream portion 2202. In some embodiments, making the downstream and/or upstream portions from sheet metal rather than metal tubing potentially enables a more continuous line of contact with surrounding tissue for better sealing.

Reference is now made to fig. 23, which is a simplified illustration of a portion 2300 of a heart valve support, according to an example embodiment of the invention.

Fig. 23 depicts a portion 2300 of a heart valve support that can optionally be used as a downstream portion (balcony), or as an upstream portion (onion).

In some embodiments, two instances of the portion 2300 may optionally be combined to produce a heart valve support, wherein one instance of the portion 2300 serves as the upstream portion and one instance of the portion 2300 serves as the downstream portion.

In the example of the portion 2300 serving as the downstream portion, fig. 23 depicts the components serving as the balcony 2304 and as the commissure posts 2302.

In the example of the portion 2300 serving as the upstream portion, the balcony 2304 serves as an onion portion, and the commissure posts 2302 are optionally used to attach the upstream portion to the downstream portion.

The two instances are optionally attached to each other. In some embodiments, the two instances are attached to each other by attaching commissure posts 2302 to each other.

In some embodiments, the portion 2300 is optionally made from sheet metal that is cut to the design and shape for the portion 2300. In some embodiments, fabricating portion 2300 from a metal sheet rather than a metal tube potentially enables a more continuous line of contact with surrounding cardiac tissue to potentially better seal and/or for reducing injury to tissue by spreading forces over a larger area.

Reference is now made to fig. 24A, 24B and 24C, which are simplified illustrations of a cardiac valve support 2400 according to an example embodiment of the invention.

Fig. 24A is a side view of the heart valve support 2400, fig. 24B is a top view of the heart valve support 2400, and fig. 24C is an isometric view of the heart valve support 2400.

Fig. 24A, 24B, and 24C depict an upstream portion 2402 (also referred to as an onion portion) and a downstream portion 2404 (also referred to as a balcony portion). Fig. 24A, 24B, and 24C also depict three commissure posts 2406.

In the example embodiment depicted in fig. 24A, 24B, and 24C, the commissure posts 2406 optionally include three or more posts, and the onion portions 2402, balcony portions 2404, and commissure support stiffeners are optionally constructed of wires that are twisted and braided to form the above-described components. In some embodiments, the wire is a single wire that is braided to form the above-described component.

It is expected that during the life of a patent maturing from this application many relevant prosthetic heart valves will be developed and the scope of the term prosthetic heart valve is intended to include all such new technologies a priori.

As used herein, the term "about" refers to ± 10%.

The terms "comprising," including, "" having, "and combinations thereof mean" including, but not limited to.

The term "consisting of … …" is intended to mean "including and limited to.

The term "consisting essentially of … …" means that a component, method, or structure may include additional ingredients, steps, and/or portions, but only if the additional ingredients, steps, and/or portions do not materially alter the basic and novel characteristics of the claimed component, method, or structure.

As used herein, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "unit" or "at least one unit" may include a plurality of units, including combinations thereof.

The words "example" and "exemplary" are used herein to mean "serving as an example, instance, or illustration. Any embodiment described as "exemplary" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.

The word "optionally" is used herein to mean "provided in some embodiments but not provided in other embodiments". Any particular embodiment of the invention may include a plurality of "optional" features unless such features conflict.

Throughout this application, various embodiments of the invention may be presented in a range format. It is to be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have all possible subranges and individual numerical values specifically disclosed within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, e.g., 1,2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is intended to include any number (fractional or integer) recited within the indicated range. The phrases "range/range is between a first indicated number and a second indicated number" and "range/range is from a first indicated number to a second indicated number" are used interchangeably herein and are intended to include the first and second indicated numbers and all fractions and integers therebetween.

As used herein, the term "method" refers to manners, means, techniques and procedures for accomplishing a given task, including, but not limited to, those manners, means, techniques and procedures either known or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

As used herein, the term "treating" includes terminating, substantially inhibiting, delaying or reversing the progression of the condition, substantially ameliorating clinical or aesthetic symptoms of the condition, or substantially preventing the appearance of clinical or aesthetic symptoms of the condition.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of different embodiments are not considered essential features of those embodiments, unless the embodiments do not function without those elements.

While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that a section heading is used, it should not be construed as necessarily limiting.

Claims (50)

1. A device for artificial mitral valve support, comprising:

an expandable frame configured such that at least a portion of the frame is expandable to be larger than a natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus;

a pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through the commissures of the natural mitral valve;

a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing a posterior leaflet of the natural mitral valve toward a ventricular wall; and

a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts.

2. The device of claim 1, wherein the support arch comprises a bend for accommodating papillary muscles.

3. The device of claim 1, and further comprising a pair of anterior leaflet hooks, each of the pair of anterior leaflet hooks configured to engage chordae attached to the anterior leaflet and pull the anterior leaflet in opposite directions.

4. The device of claim 1 and further comprising a plurality of anterior leaflet grabbers, each of the plurality of anterior leaflet grabbers comprising one end attached to the frame and one end configured to grab the anterior leaflet of the natural mitral valve.

5. The device of claim 1, and further comprising a pair of triangular anchors, each of the pair of triangular anchors comprising one end attached to the frame and one end configured to push against a heart valve trigone.

6. The device of claim 1 in which the support arch is configured to be between 2 and 20 millimetres below an annular plane of the natural mitral valve when placed in the natural mitral valve.

7. The device of claim 6, wherein said support arch is covered by a sheet of flexible material.

8. The device of claim 1 in which the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and push the natural mitral valve annulus into the shape of the D-shaped section.

9. The device of claim 8, wherein the support arch is configured to be between 5 and 20 millimeters larger than a diameter of the D-shaped section of the frame.

10. The device of claim 8, wherein the support arch is configured to be between 2 and 20 millimeters from an upstream edge of the D-shaped section of the frame.

11. The device of claim 8 in which the D-shaped section comprises a lumen having lumen walls parallel to the axis of the natural mitral valve annulus.

12. The device of claim 11, wherein the lumen wall of the D-shaped section is in a range between 5 millimeters and 15 millimeters long.

13. The device of claim 1, and further comprising a commissure arch attaching a downstream end of a first of the commissure posts to a downstream end of a second of the commissure posts.

14. A method of supporting an artificial mitral valve, comprising:

providing a frame for anchoring the artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to be expandable to a diameter greater than the natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus, the frame further comprising:

a pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through the commissures of the natural mitral valve;

a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing a posterior leaflet of the natural mitral valve toward a ventricular wall; and

a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts,

positioning at least a portion of the frame in the left atrium;

passing the posterior extension and the supporting arch through the natural mitral valve commissures so as to push against the posterior leaflet of the natural mitral valve toward a ventricular wall; and

positioning the commissure posts at the natural mitral valve commissures.

15. The method of claim 14, wherein the frame further comprises a pair of hooks, and further comprising engaging a cord attached to the anterior leaflet with each of the pair of hooks.

16. The method of claim 14 in which the frame further comprises an anterior leaflet grabber, the anterior leaflet grabber comprising a plurality of extensions, each of the plurality of extensions comprising one end attached to the frame and one end configured to grab an anterior leaflet of the natural mitral valve, and further comprising using the anterior leaflet grabber to grab the natural anterior mitral valve leaflet.

17. The method of claim 14 in which the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and to push the natural mitral valve annulus into the shape of the D-shaped section, and further comprising placing the D-shaped section of the frame at the natural mitral valve annulus.

18. A device for artificial mitral valve support, comprising:

an expandable frame configured such that at least a portion of the frame is expandable to be larger than a natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus;

a pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through the commissures of the natural mitral valve; and

an anterior leaflet grabber comprising a plurality of extensions, each of the plurality of extensions comprising one end attached to the frame and one end configured to grab an anterior leaflet of the natural mitral valve.

19. The device of claim 18, and further comprising a pair of hooks, each of the pair of hooks configured to engage chordae attached to the anterior leaflet and pull the anterior leaflet in opposite directions.

20. The device of claim 18, and further comprising:

a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing a posterior leaflet of the natural mitral valve toward a ventricular wall; and

a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts.

21. A method of supporting an artificial mitral valve, comprising:

providing a frame for anchoring the artificial mitral valve configured to be placed upstream of a natural mitral valve annulus and shaped to expand larger than the natural mitral valve annulus to prevent downstream displacement of the frame toward the natural mitral valve annulus;

the frame further comprising a plurality of anterior leaflet grabbers, each of the plurality of anterior leaflet grabbers comprising one end attached to the frame and one end configured to grab an anterior leaflet of the natural mitral valve,

and also comprises grasping the natural anterior mitral valve leaflet using the anterior leaflet grasper.

22. The method of claim 21 in which the frame further comprises a pair of hooks, and further comprising engaging chordae attached to the natural anterior mitral valve leaflet with each of the pair of hooks.

23. The method of claim 21, wherein the frame further comprises

A pair of commissure posts attached at one end to the frame, the commissure posts configured to extend downstream of the mitral valve annulus through the commissures of the natural mitral valve;

a posterior extension attached at a first end to the frame, the posterior extension configured to extend downstream of the mitral valve annulus and partially reverse and outward, thereby pushing a posterior leaflet of the natural mitral valve toward a ventricular wall; and

a support arch attaching the downstream end of a first one of the commissure posts to the downstream end of the posterior extension to the downstream end of a second one of the commissure posts,

and further comprising:

passing the posterior extension and the supporting arch through the natural mitral valve commissures so as to push against the posterior leaflet of the natural mitral valve toward a ventricular wall; and

positioning the commissure posts at the natural mitral valve commissures.

24. The method of claim 21 in which the frame comprises a D-shaped section of the frame configured to be placed at the natural mitral valve annulus and to push the natural mitral valve annulus into the shape of the D-shaped section, and further comprising placing the D-shaped section of the frame at the natural mitral valve annulus.

25. A device for a prosthetic heart valve support, the device comprising:

an upstream portion designed to expand to have at least one dimension wider than a native heart valve annulus;

a downstream portion attached to the upstream portion, the downstream portion also designed to expand such that at least a portion has at least one dimension wider than a native heart valve annulus; and

a plurality of prosthetic valve commissure posts.

26. The device of claim 25, wherein the upstream portion and the downstream portion comprise separate components designed to be attached to each other.

27. The device of claim 25, wherein the commissure posts are attached to the downstream portion.

28. The device of claim 25, wherein the commissure posts are attached to the upstream portion.

29. The device of claim 25, wherein the downstream portion comprises an expandable mesh designed to expand to a diameter greater than the diameter of the native heart valve annulus.

30. The device of claim 25, wherein the downstream portion comprises a single ring having a diameter greater than the diameter of the native heart valve annulus.

31. The device of claim 25, wherein the downstream portion comprises a single asymmetrically-shaped ring having at least one dimension greater than a diameter of the native heart valve annulus.

32. The device of claim 25, wherein the downstream portion further comprises support arcs connecting the commissure posts.

33. The device of claim 32, wherein the support arcs are designed to expand against native heart leaflets.

34. The device of claim 32, wherein the support arcs are designed to expand such that the downstream portion has a diameter that is larger than the diameter of the native heart valve annulus.

35. The device of claim 25, wherein the commissure posts comprise holes for suturing the flexible sheet.

36. The device of claim 25, wherein the plurality of commissure posts consists of three commissure posts.

37. The device of claim 25, wherein the commissure posts extend downstream, then curve outward and are attached to a balcony having a diameter that is greater than a width of the native heart valve annulus in at least one direction.

38. The device of claim 25, and further comprising a support bar between the commissure posts.

39. The device of claim 38, wherein the support rods extend downstream and then curve outward to be attached to a balcony having a diameter at least in one direction greater than a width of the native heart valve annulus.

40. The device of claim 25, wherein the upstream portion comprises an expandable mesh designed to expand to a diameter larger than the diameter of the native heart valve annulus.

41. The device of claim 25, wherein the upstream portion comprises a single loop designed to expand to a diameter larger than the diameter of the native heart valve annulus.

42. The device of claim 25, wherein the upstream portion comprises a single asymmetrically-shaped ring having at least one dimension greater than a diameter of the native heart valve annulus.

43. The device of claim 25, and further comprising a flexible sheet attached to the commissure posts and designed to act as a prosthetic heart valve, thereby allowing blood flow from an upstream side to a downstream side of the device and preventing blood flow from the downstream side to the upstream side of the device.

44. The device of claim 43, wherein said flexible sheet comprises several flexible sheets designed and attached to each other to form said prosthetic heart valve.

45. The device of claim 43, wherein the flexible sheet comprises a woven fabric.

46. The device of claim 43, wherein the flexible sheet comprises a biocompatible synthetic sheet.

47. The device of claim 43, wherein the flexible sheet comprises a pericardium tissue sheet.

48. The device of claim 43, wherein the flexible sheet is attached to the device and is designed to expand freely until contacting a wall of a native heart.

49. A method for producing a device for artificial heart valve support, the method comprising:

producing an upstream portion;

producing a downstream portion; and

attaching the upstream portion to the downstream portion to produce a frame for a prosthetic heart valve support.

50. The method of claim 49, and further comprising suturing a flexible sheet to the frame, thereby producing a prosthetic heart valve sutured to the frame.