WO2016108181A1

WO2016108181A1 - Cardiac prostheses

Info

Publication number: WO2016108181A1
Application number: PCT/IB2015/060023
Authority: WO
Inventors: Boris Orlov; Ehud RAANANI
Original assignee: Tel Hashomer Medical Research, Infrastructure And Services Ltd.
Priority date: 2014-12-30
Filing date: 2015-12-29
Publication date: 2016-07-07

Abstract

A cardiac valve prosthesis comprising: a prosthetic mitral valve (PMV) for replacing a native mitral valve of a subject; a prosthetic aortic valve (PAV) for replacing a native aortic valve of the subject; and at least one bridge that couples the PAV to the PMV.

Description

CARDIAC PROSTHESES

RELATED APPLICATIONS

[0001] The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional

Application 62/097,935 filed on December 30, 2014, the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] Embodiments of the disclosure relate to cardiac valve prosthesis.

BACKGROUND

[0003] The human heart, and generally all mammalian hearts, comprises two blood pumps that operate in synchrony to oxygenate blood and deliver oxygenated blood to the body. A first pump receives deoxygenated blood after it has coursed through blood vessels in the circulatory system and pumps the deoxygenated blood to the lungs. The second pump receives oxygenated blood from the lungs and pumps it to flow through the blood vessels of the circulatory system and deliver oxygen and nutrients to the rest of the body.

[0004] The two pumps are located adjacent each other in the heart and each pump comprises two chambers, an atrium that receives blood and a ventricle that pumps blood. The first pump, located on the right side of the heart, receives deoxygenated blood from blood vessels called the superior vena cava and inferior vena cava and pumps the blood out to the lungs through a blood vessel called the pulmonary artery. The second pump, which is located on the left side of the heart, receives oxygenated blood from the lungs through a blood vessel called the pulmonary vein and pumps out the blood to the body through a blood vessel called the aorta. The atrium and ventricle of the first pump are referred to as the right atrium and right ventricle, respectively, and the atrium and ventricle of the second pump are referred to as the left atrium and left ventricle, respectively.

[0005] The heart cycle comprises two phases called diastole and systole. During diastole, the ventricles are relaxed and blood flows into each ventricle from its respective atrium. During systole, the ventricles contract to pump blood out. In the first pump, during diastole, the deoxygenated blood in the right atrium flows from the relaxed right atrium into the right ventricle via a one-way valve referred to as a tricuspid valve. During systole, the right ventricle contracts to pump the deoxygenated blood that it receives from the right atrium and into the pulmonary artery via a one-way valve referred to as the pulmonary valve. The tricuspid and pulmonary valves control direction of blood flow in the right side of the heart. In the second pump, during diastole, oxygenated blood in the left atrium flows into the relaxed left ventricle via a one-way valve referred to as the mitral valve ("MV"). During systole, the left ventricle contracts to pump the blood that it receives from the left atrium out of the heart through a one-way valve referred to as the aortic valve ("AV") and into the aorta, for delivery to the body.

[0006] Each valve comprises a set of matching "flaps", also referred to as "leaflets" or "cusps", that are mounted to and extend from a supporting structure of fibrous tissue. The supporting structure has a shape reminiscent of an annulus and is often conventionally referred to as "the annulus" of the valve. The mitral valve is a bicuspid valve comprising two leaflets. The aortic, pulmonary and tricuspid valves each comprise three leaflets. Each valve closes when the leaflets align (or coapt) along free edges of the leaflets. The valve opens when the leaflets are pushed away from each other and their free edges part. The leaflets in a valve open and close in response to a gradient in blood pressure across the valve that is generated by a difference in blood pressure between opposite sides of the valve. The intended direction for blood flow through the valve may be referred to hereinafter as "downstream flow" or antegrade direction. For example, leaflets in the mitral valve are pushed apart during diastole to open the mitral valve and allow blood flow from the left atrium into the left ventricle when pressure in the left atrium is greater than pressure in the left ventricle. The leaflets in the mitral valve are pushed together so that their edges coapt to close the valve during systole when pressure in the left ventricle is greater than pressure in the left atrium to prevent regurgitation of blood into the left atrium.

[0007] A cardiac valve may become compromised and not function properly as a result of disease or injury to an extent that warrants surgical intervention to effect its repair or replacement. By way of an example, structure and/or operation of a cardiac valve may be compromised by abnormal narrowing, or stenosis, which limits blood flow through the valve. By way of another example, improper or incomplete coapting of the valve leaflets may result in regurgitation of blood in the retrograde direction.

SUMMARY

[0008] An aspect of an embodiment of the disclosure relates to providing a cardiac valve prosthesis comprising two coupled prosthetic cardiac valves. Another aspect of an embodiment of the disclosure relates to providing a method of deploying the cardiac valve prosthesis comprising the coupled prosthetic cardiac valves to replace native cardiac valves in a same procedure.

[0009] The cardiac valve prosthesis in accordance with an embodiment of the disclosure comprises a prosthetic mitral valve (PMV) for replacing a native MV, a prosthetic aortic valve (PAV) for replacing a native AV, and at least one bridge coupling the PMV and the PAV. Each of the PMV and the PAV comprises a wire mesh scaffold and a set of prosthetic leaflets mounted to the scaffold that coapt to close the valve and separate to open the valve. Optionally, the at least one bridge coupling the PAV and PMV comprises a wire mesh. Optionally, the at least one bridge is integrally formed with the scaffolds of the PAV and PMV. Optionally the at least one bridge comprises two bridges.

[0010] When the cardiac valve prosthesis is deployed, the PMV and PAV seat in the annuli of the native MV and AV valves that they respectively replace and are positioned folded back toward each other. The PMV, PAV, and their adjoining at least one bridge, grip and hold cardiac tissue located between the aortic and mitral valves. The seating of both prosthetic valves in the annuli of the native cardiac valves that they respectively replace anchors the deployed cardiac valve prosthesis to the heart in two locations. The double anchoring of the two prosthetic valves, together with the gripping of cardiac tissue between the MV and AV by the prosthetic valves and the at least one bridge, promotes maintaining the cardiac valve prosthesis and both prosthetic valves stably positioned in their deployed state in the heart.

[0011] For convenience of presentation, the cardiac valve prosthesis in accordance with an embodiment of the disclosure may be referred to hereinafter as an "Aorto-Mitral Continuity Anchoring System" or "AMCA system".

[0012] In the discussion, unless otherwise stated, adjectives such as "substantially" and "about" modifying a condition or relationship characteristic of a feature or features of an embodiment of the disclosure, are understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended. Unless otherwise indicated, the word "or" in the description and claims is considered to be the inclusive "or" rather than the exclusive or, and indicates at least one of, or any combination of items it conjoins.

[0013] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF FIGURES

[0014] Non-limiting examples of embodiments of the disclosure are described below with reference to figures attached hereto that are listed following this paragraph. Identical features that appear in more than one figure are generally labeled with a same label in all the figures in which they appear. A label labeling an icon representing a given feature of an embodiment of the disclosure in a figure may be used to reference the given feature. Dimensions of features shown in the figures are chosen for convenience and clarity of presentation and are not necessarily shown to scale.

[0015] Fig. 1A schematically shows an AMCA system in accordance with an embodiment of the disclosure in a deployed state;

[0016] Fig. IB schematically shows an alternative AMCA system in accordance with an embodiment of the disclosure;

[0017] Fig. 1C schematically shows an AMCA system in a collapsed state and front-loaded in a transcatheter deployment system;

[0018] Figs. 2A-2F schematically show deployment of the AMCA system in a heart of a subject, in accordance with an embodiment of the disclosure;

[0019] Figs. 3A-3D schematically show an alternative method for deployment of the AMCA system in a heart of a subject, in accordance with an embodiment of the disclosure;

[0020] Fig. 4A schematically shows an AMCA system in accordance with an embodiment of the disclosure;

[0021] Fig. 4B schematically shows an AMCA system comprising an alternative bridge in accordance with an embodiment of the disclosure; and

[0022] Fig. 4C schematically shows a portion of a heart including a mitral valve and an aorta.

DETAILED DESCRIPTION

[0023] Fig. 1A schematically shows an AMCA system 100 in accordance with an embodiment of the disclosure, in an expanded state, in substantially a shape that AMCA system 100 assumes when deployed in the heart (not shown). AMCA system 100 comprises a PMV 110 that seats in and replaces a native MV (not shown) of a heart of a subject and, PAV 120 that seats in and replaces a native AV (not shown) in the same heart and a bridge 130 that couples the two prosthetic valves.

[0024] PMV 110 comprises a wire mesh scaffold 112 that is configured so that, when positioned between the leaflets (or through a puncture in a leaflet) of the native MV it is intended to replace and released to expand to the deployed state, it pushes aside the native leaflets and replaces the native MV valve. PAV 120 comprises a wire mesh scaffold 122 that is configured so that, when positioned between the leaflets (or through a puncture in a leaflet) of the native AV it is intended to replace and released to expand to the deployed state, it pushes aside the native leaflets and replaces the native AV valve. Optionally, bridge 130 comprises wire mesh. Optionally, bridge 130 is integrally formed with PMV scaffold 112 and PAV scaffold 122. Optionally, PMV scaffold 112, PAV scaffold 122, and/or bridge 130 is configured to self expand, or be expanded by balloon, from a collapsed state to an expanded, or "deployed", state.

[0025] PMV 110 comprises a set of prosthetic leaflets (not shown) that is mounted within a lumen of PMV scaffold 112. PAV 120 comprises a set of prosthetic leaflets (not shown) that is mounted within a lumen of PAV scaffold 122. When AMCA system 100 is in the deployed state, the set of prosthetic leaflets in the PMV and PAV, respectively, provides a one-way valve functionality, separating and coapting in response to differences in blood pressure between the downstream and upstream sides of the respective prosthetic valves so that blood flows selectively in the downstream direction. The sets of prosthetic leaflets are capable of being collapsed together with the respective scaffold into a collapsed state, then being expanded together with the scaffold to provide the one-way valve functionality in a deployed state. Optionally, each of the prosthetic leaflet sets comprises three leaflets comprising porcine or bovine pericardial tissue, arranged in a trileaflet configuration.

[0026] In an embodiment of the disclosure, PMV scaffold 112 comprises an upstream skirt 114 and a downstream skirt 116 that are joined at a waist 115. PMV scaffold 112 is shaped and dimensioned so that waist 115 seats at the annulus of the native MV with upstream skirt 114 located in the left atrium and downstream skirt 116 located in the left ventricle. Optionally, in the deployed state, waist 115 is narrow relative to the skirts 114, 116. Optionally, in the deployed state, upstream skirt 114 is wide relative to waist 115 and downstream skirt 116 is substantially the same width as waist 115.

[0027] In an embodiment of the disclosure, the PAV scaffold 122 comprises an upstream skirt 124 and a downstream skirt 126 that are joined at a waist 125. Optionally, the waist is narrow relative to the skirts. PAV scaffold 122 is shaped and dimensioned so that waist 125 seats at the annulus of the native AV with upstream skirt 124 located in the left ventricle and downstream skirt 126 located in the aorta.

[0028] In an embodiment of the disclosure, the wire mesh of at least one of PMV scaffold 112, PAV scaffold 122, and bridge 130 comprises nitinol. Optionally, a given portion of AMCA system 100 comprising nitinol has a shape memory of a deployed state (such as deployed state of AMCA system 100 shown in Fig. 1A, in accordance with an embodiment of the disclosure) so that the ninitol-comprising portion converts from a collapsed state (such as shown in Fig. 1C) into the deployed state when in ambient body temperature in the absence of physical barriers that maintain the AMCA system in a collapsed state. In an embodiment of the disclosure, the wire mesh of at least one of PMV scaffold 112, PAV scaffold 122, and bridge 130 comprises stainless steel. Optionally, a given portion of AMCA system 100 comprising stainless steel is expanded from a collapsed state into a deployed state by expanding a balloon placed in a lumen of the given portion of the AMCA system. Advantageously, the wire mesh of the PMV scaffold comprises nitinol having a shape memory that substantially matches the dimensions of the native MV annulus and optionally its surrounding tissue, so that there is little or no excess pressure applied to the MV annulus during deployment of the PMV.

[0029] Fig. IB schematically shows an alternative AMCA system 1100 in accordance with an embodiment of the disclosure wherein a wire mesh of a PMV 1110 is integrally formed with a wire mesh of a bridge 1130. A PAV 1120 comprising wire mesh is formed as a separate component. After formation of the PAV and the integrated PMV and bridge, the wire mesh of the PAV is attached to the wire mesh of bridge 1130 optionally at a distal end 1132 of bridge 1130. The attachment may be done, by way of example, through soldering and/or sewing. By way of example, the wire mesh of integrally formed PMV 1110 and bridge 1130 comprise nitinol, and the wire mesh of PAV 1120 comprises stainless steel.

[0030] Fig. 1C schematically shows a transcatheter deployment system 200 (TDS) for deploying AMCA system 100 in a subject's heart in accordance with an embodiment of the disclosure. TDS 200 comprises a delivery tube 210 having a distal end 212 for inserting into the heart and a proximal end (not shown) that remains outside the subject's body when distal end 212 is positioned inside the subject's heart. AMCA system 100 is front-loaded in a collapsed state into a lumen 214 of delivery tube 210 near distal end 212. AMCA system 100 may be substantially cylindrical in shape when in the collapsed state. Optionally, bridge 130, while in the collapsed state, may be shaped substantially as a partial cylinder. Optionally, and depending of the deployment method, AMCA system 100 is loaded into delivery tube 210 so that PMV 110 is closer to distal end 212 than PAV 120 (as shown in Fig. 1C). Alternatively, AMCA system 100 is loaded into delivery tube 210 so that PAV 120 is closer to distal end 212 than PMV 110. Methods of deploying an AMCA system in accordance with an embodiment of the disclosure are discussed below with reference to Figs. 2A-2E and Figs. 3A-3D.

[0031] TDS 200 may further comprise a stopper 220 that is connected to a distal end 232 of a deployment tube 230. Stopper 220 and at least a portion of deployment tube 230 are located inside the lumen of delivery tube 210 and are capable of moving along the longitudinal axis of delivery tube 210 in relation to and independently of delivery tube 210. Stopper 220 is shaped and dimensions so that it abuts an end 150 of collapsed AMCA system 100 within lumen 214, so that when stopper 220 is moved towards distal end 212 of delivery tube 210 (or alternatively when delivery tube 210 is moved back in relation to stopper 220 so that distal end 212 approaches stopper 220), loaded AMCA system 100 exits delivery tube from distal end 212.

[0032] TDS 200 optionally comprises a guidewire 240 located in lumen 214 of delivery tube 210. Guidewire 240 traverses through a lumen 234 of deployment tube 230, a lumen (not shown) of stopper 220 and a lumen 160 of collapsed AMCA system 100 so that a distal end 242 of guidewire 240 reaches distal end 212 of delivery tube 210. Distal end 242 of guidewire 240 is optionally attached to nosecone 250 that is optionally connectable and detachable from distal end 212 of delivery tube 210.

[0033] Fig. 1C further schematically shows AMCA system 100 outside of TDS 200 and in an expanded state, with bridge 130 shown in a substantially unbent configuration. Block arrows 310, 320 and 330 relate PMV 110, PAV 120 and bridge 130 in the expanded state, respectively, to equivalent components of collapsed AMCA system 100 loaded inside TDS 200.

[0034] Figs. 2A-2E schematically show a transcatheter procedure of deploying AMCA system 100 into a human heart 10 using TDS 200, to replace the MV and the AV with a PMV and a PAV, respectively, with a single apparatus and procedure, in accordance with an embodiment of the disclosure. The procedure in accordance with an embodiment of the disclosure may be referred to herein as "double valve replacement procedure" or "DVRP".

[0035] Fig. 2A shows a schematic, stylized cross section of a human heart 10 showing a left atrium 22, a left ventricle 24 and ascending aorta 26. Left atrium 22 and left ventricle 24 communicate via a MV 30, and left ventricle and ascending aorta 26 communicate via AV 40. MV 30 has two leaflets, anterior leaflet 32 that is in continuity with the wall of the aorta and posterior leaflet 34. Both anterior leaflet 32 and posterior leaflet 34 are supported by and extend from a mitral annulus 36. MV leaflets 32 and 34 are respectively tied by chordae tendineae 12 and papillary muscles 14 to ventricle wall 16.

[0036] Oxygenated blood from the lungs enters left atrium 22 and passes through MV 30 to enter left ventricle 24 during diastole when left ventricle 24 is relaxed and MV leaflets 32 and 34 are separated (as shown in Fig. 2A) to open MV 30. Flow of oxygenated blood from the left atrium into the left ventricle during diastole is schematically indicated by a block arrow 52. During diastole, leaflets 42 coapt to close AV 40 and prevent oxygenated blood in aorta 26 from regurgitating into left ventricle 24. Two of three leaflets 42 of AV 40 are shown in Fig. 2 A. During systole (not shown), left ventricle 24 contracts to pump oxygenated blood from the left ventricle through AV 40 into aorta 26 for delivery to the body. Flaps 42 of AV 40 are opened during systole by the rise in blood pressure in the left ventricle relative to blood pressure in aorta 26 as a result of left ventricle contraction. Flow of oxygenated blood from the left ventricle into the aorta during systole is schematically indicated by a dashed block arrow 54. During systole, MV leaflets 32 and 34 coapt to close MV 30 and prevent oxygenated blood pumped by the left ventricle from regurgitating into the left atrium.

[0037] In the DVRP in accordance with an embodiment of the disclosure, a TDS 200 is front-loaded with AMCA system 100 in a cylindrical collapsed state with PMV 110 closer to distal end 212 of delivery tube 210 than PAV 120, as shown in Fig. 1C. In an embodiment of the disclosure, loaded TDS 200 is inserted into the heart from an artery in the retrograde direction, with nosecone 250 traversing through aorta 26, AV 40, left ventricle 24 and MV 30 until the nosecone 250 with the distal end of the delivery tube reaches left atrium 22. In accordance with an embodiment of the disclosure, TDS 200 is properly positioned for deployment when nosecone 250 and distal end 212 are positioned in left atrium 22, collapsed PMV 110 is positioned at MV 30, collapsed bridge 130 is positioned inside left ventricle 24, and collapsed PAV 120 is positioned at AV 40. [0038] Optionally, during the insertion of TDS 200 into the heart, nosecone 250 traverses MV 30 through a gap between MV leaflets 32 and 34 (shown in Figs. 2A-2F). Alternatively, nosecone may traverse the MV by puncturing anterior leaflet 32 and passing through the resulting puncture in the anterior leaflet (not shown), so that bridge 130 is positioned in the punctured anterior leaflet. Optionally, TDS 200 is first inserted into the subject through a peripheral artery, for example a femoral artery, then guided to the aorta and the heart, while keeping proximal portions (not shown) of delivery tube 210, deployment tube 230, and guide wire 240, respectively, external to the subject's body and available to a surgeon (not shown) for manual or automated movement along their respective longitudinal axes.

[0039] Once TDS 200 is properly positioned within the heart (Fig. 2B), PMV 110 is ejected from distal end 212 so that it deploys to seat within MV 30 (Figs. 2B-2C), bridge 130 is ejected from distal end 212 so that it is deployed within left ventricle 24 (Figs. 2C-2D); and PAV 120 is ejected from distal end 212 so that it deploys to seat within AV 40 (Figs. 2D-2E). After AMCA system 100 is fully deployed within the heart, the remainder of TDS 200 pulled back from heart 10 and guided back in the antegrade direction out of the heart and the body of the subject, leaving deployed AMCA system 100 in the heart (Fig. 2E).

[0040] As schematically shown in Figs. 2B-2D, PMV 110, bridge 130 and PAV 120 comprised in AMCA system 100 are sequentially ejected from TDS 200 through progressively pulling delivery tube 210 back in the antegrade direction, as shown by block arrow 350 in Figs. 2B-2D, while keeping deployment tube 230 and connected stopper 220 stationary relative to the delivery tube. Stopper 220 prevents the loaded and collapsed AMCA system from being pulled back together with delivery tube 210, and the AMCA system is thus progressively ejected from distal end 212 of delivery tube 210.

[0041] In an embodiment of the disclosure, TDS 200 traverses left ventricle 24 between AV 40 and MV 30 around anterior MV leaflet 32, as shown in Figs. 2B. Alternatively, TDS 200 traverses left ventricle 24 between AV 40 and MV 30 by going through a puncture (not shown) in anterior MV leaflet 32.

[0042] Reference is now made to Fig. 2E. Once deployed in the heart, PMV 110, with its set of prosthetic leaflets (not shown) forms a functional replacement valve that responds to blood pressure gradients between left atrium 22 and left ventricle 24 to open during diastole and close during systole. PAV 120, with its set of prosthetic leaflets (not shown), forms a functional replacement valve that responds to blood pressure gradients between aorta 26 and left ventricle 24 to open during systole and close during diastole.

[0043] Optionally, at least a portion of upstream skirt 114 of PMV scaffold 112 is wider than MV annulus 36 for seating on a portion of left atrium 22 near or adjacent to the MV annulus and preventing PMV 110 from being dislodged into left ventricle 24. Optionally, downstream skirt 116 is shaped to seat on the upstream surface of anterior MV leaflet 32 and posterior MV leaflet 34, and keeps the leaflets in an open position. Optionally, at least a portion of downstream skirt 116 is wider than the diameter of MV annulus 36 to prevent PMV 110 from being dislodged into left atrium 22.

[0044] Optionally, in the deployed state, at least a portion of downstream skirt 126 is wider than the diameter of AV annulus 46 to prevent PAV 120 from being dislodged into left ventricle 24. Optionally, in the deployed state, at least a portion of downstream skirt 126 generates outward pressure on the interior wall of aorta 26, thus contributing to securing PAV 120 in AV 40. Optionally, in the deployed state, downstream skirt 126 seats on the upstream surface of AV leaflets 42 and keeps the leaflets in an open position. Optionally, in the deployed state, at least a portion of upstream skirt 124 of PAV scaffold 122 is wider than AV annulus 46 and seats on a portion of left ventricle 24 near or adjacent to AV annulus 46 to prevent PAV 120 from being dislodged into aorta 26. Alternatively, in the deployed state, upstream skirt 124 is substantially the same width as waist 125. Optionally, in the deployed state, at least a portion of downstream skirt 126 is wider than waist 125 and AV annulus 46, and upstream skirt 124 is substantially the same width as waist 125.

[0045] Optionally, downstream skirt 116 of PMV scaffold 112 is contoured so that native MV leaflets 32 and 34 embrace downstream skirt 116 during systole to prevent or reduce leakage of blood around the exterior of the PMV. Optionally, downstream skirt 126 of PAV scaffold 122 is contoured so that native AV leaflets 42 embrace downstream skirt 126 during diastole to prevent or reduce leakage of blood around the exterior of the PAV.

[0046] In an embodiment of the disclosure, during or after deployment of PMV 110, the PMV may be rotated around the longitudinal axis of the MV so that at least a portion of posterior leaflet 34 and optionally additionally anterior leaflet 32 becomes wrapped around wire mesh 112. The PMV may initially be inserted into the MV being rotationally offset from a desired orientation in relation to the MV, then rotated to the desired orientation after the PMV is fully or partially deployed. Optionally, the rotation of the PMV is done when PMV 110 is partially ejected from delivery tube 210. Optionally, the rotational offset from the desired orientation is between 135 degrees and 45 degrees, or about 90 degrees. The wrapping of the leaflet(s) around the frame of PMV 110 contributes to securing the PMV at MV 30 and to reducing leakage around the PMV. Optionally, the rotation of the PMV is done prior to deployment of PAV 120 and optionally bridge 130. Optionally, bridge 130 is sufficiently flexible and/or has sufficient freedom of movement to adapt to rotational movement of the PMV relative to the PAV.

[0047] In an embodiment of the disclosure, when AMCA system 100 is deployed, with PMV 110 and PAV 120 seated in annuli 36 and 46 respectively of the native MV and AV valves that they respectively replace, the PMV and PAV are positioned folded back toward each other. PMV 110, PAV 120, and their adjoining bridge 130, thus grip and hold cardiac tissue located between MV 30 and AV 40. The seating of both prosthetic valves 110 and 120 in the annuli of the native cardiac valves that they respectively replace anchors deployed AMCA system 100 to the heart at two locations. Downstream skirt 126 of PAV 120 may be shaped to provide outward pressure to the inner wall of aorta 26, providing additional or alternative anchoring of the PAV. The double anchoring of the two prosthetic valves at MV annulus 36 and AV annulus 46, together with the gripping of cardiac tissue between MV 30 and AV 40 by the prosthetic valves and their bridge, promotes maintaining and stably positioning AMCA system 100, including both prosthetic valves 110 and 120, in their deployed state within the heart.

[0048] In an embodiment of the disclosure, PMV 110, PAV 120 and bridge 130 in the deployed state as shown in Fig. 2E may form an inlet 140 that is contoured to fit around a free edge of MV anterior leaflet 32, so that the inlet contacts both the upstream and downstream surfaces of the MV anterior leaflet. A shape of inlet 140 optionally functions to grip anterior leaflet 32, thus aid in securing AMCA system 100 within the heart. Alternatively, when deployed bridge 130 traverses a puncture (not shown) in MV anterior leaflet 32, the anterior leaflet contributes to securing AMCA system 100 in the heart.

[0049] Reference is now made to Fig. 2F, which as in Fig. 2E schematically shows AMCA system 100 deployed in heart 10, with PMV 110 deployed in MV 30, PAV 120 deployed in AV 40, and bridge 130 connecting the PMV to the PAV. In addition Fig, 2F schematically shows dashed lines CS1 and CS2 that pass substantially through planes of MV annulus 36 and AV annulus 46, respectively. [0050] The cardiac cycle is a dynamic process in an organ, the heart, which comprises relatively flexible tissue. By way of example, while the annuli of the cardiac valves are relatively stiff and inflexible, the shape and size of the atria and ventricles are constantly changing during the cardiac cycle. As such, the position and orientation of MV annulus 36 and AV annulus 46 relative to each other changes between systole and diastole. By way of example, the spatial relationship between the MV and the AV may be characterized with an aortomitral angle, which may be defined as an angle a between planes CS1 and CS2. During the cardiac cycle, the difference between maximum and minimum aortomitral angles may be about 11 degrees. In an embodiment of the disclosure, bridge 130 is sufficiently flexible and/or has sufficient freedom of movement so that dynamic changes in the aortomitral angle during the cardiac cycle are substantially the same after deployment of AMCA system 100. Optionally, the difference between the maximum and minimum aortomitral angle is substantially the same before and after deployment of the AMCA system in the heart.

[0051] Figs. 3A-3D schematically show a transseptal DVRP in accordance with an embodiment of the disclosure. Fig. 3A shows a stylized cross section of human heart 10 showing, in addition to left atrium 22, left ventricle 24 and ascending aorta 26, a right atrium 23 and a right ventricle 25. In addition, Fig. 3 A schematically shows a guidewire 241, optionally comprising an internal coaxial guidewire 242, that has been inserted in an antegrade direction into the heart from a vein, by way of example a femoral vein or a jugular vein, through inferior vena cava 27 (or alternatively superior vena cava) and into right atrium 23. In accordance with an embodiment of the disclosure, guidewire 241 may create a puncture 56 in interatrial septum 57, and guided from right atrium 23 through the puncture, through left atrium 22, through MV 30, through left ventricle 24, through AV 40 and into aorta 26.

[0052] Reference is now made to Fig. 3B, showing a TDS 1200 comprising guidewires 241 and 242, nosecone 250 and delivery tube 210 front-loaded with AMCA system 100. In the transseptal DVRP in accordance with an embodiment of the disclosure, TDS 1200 is front-loaded with AMCA system 100 in the collapsed state with PAV 120 closer to distal end 212 of delivery tube 210 than PMV 110. To prepare for deployment of AMCA system 100, TDS 1200 is inserted into the vein and into the heart under guidance by guidewire 241 until the TDS is positioned so that nosecone 250 and distal end 212 are located in aorta 26, collapsed PAV 120 is positioned at AV 40, collapsed bridge 130 is positioned inside left ventricle 24, and collapsed PMV 110 positioned at MV 30. Proximal portions (not shown) of delivery tube 210, deployment tube 230, and guidewires 241 and 242, respectively, are kept external to the subject's body and available to a surgeon (not shown) for manual or automated movement along their respective longitudinal axes. Once TDS 1200 is properly positioned, PAV 120 is ejected from distal end 212 so that it deploys to seat within AV 40 (Figs. 3B-3C); bridge 130 is ejected from distal end 212 so that it deploys within left ventricle 24 (Figs. 3C-3D); and PMV 110 is ejected from distal end 212 so that it deploys to seat within MV 30 (Fig. 3D). AMCA system 100 may optionally be ejected from delivery tube 210 with a stopper (now shown, but shown by way of example as stopper 220 in Figs. 2B-2D) that may be moved along the longitudinal axis of delivery tube 210. After AMCA system 100 is fully deployed within the heart, the remainder of TDS 1200 pulled back from heart 10 and guided back in the retrograde direction out of the heart and the body of the subject, leaving deployed AMCA system 100 in the heart.

[0053] In an embodiment of the disclosure, as shown in Fig. 3B, at least a portion of downstream skirt 126 of PAV 120 is collapsed within nosecone 250, with the remainder of the AMCA system being collapsed inside delivery tube 210. After TDS 1200 is in place with nosecone 250 within aorta 26, delivery tube 210 is pulled back while downstream skirt 126 is kept inside nosecone 250, so that the portion of AMCA system 100 that is first ejected made to expand into a deployed state is upstream skirt 124. Following the ejection of upstream skirt 124, nosecone 250 is pushed out in relation to delivery tube 210 and AMCA system 100 so that downstream skirt 126 is ejected from the nosecone and deployed in aorta 26 (Fig. 3C).

[0054] Fig. 4A shows an alternative view of AMCA system 100 in the substantially unbent configuration shown in Fig. 1C, which has been rotated 90 degrees along axis A. As shown in Fig. 4A, bridge 130 may comprise a strip of wire mesh that connects PMV 110 and PAV 120.

[0055] Fig. 4B shows, in a same perspective as Fig. 4A, an alternative AMCA system 2100 in accordance with an embodiment of the disclosure that is substantially the same as AMCA system 100, with the exception of having a split bridge 2130 comprising two relatively narrow strips 2132 that connect PMV 110 and PAV 120.

[0056] Reference is now made to Fig. 4C, which shows a portion of heart 10 oriented to provide a view of the atrial surface of MV 30 and the exterior of ascending aorta 26. MV 30 comprises MV annulus 36 to which anterior leaflet 32 and posterior leaflet 34 are attached and supported. A junction 37 between the anterior leaflet and the posterior leaflet may be referred to as a MV commissure. [0057] In accordance with an embodiment of the disclosure, bridge 2130 is shaped and dimensioned so that, when AMCA system 100 is deployed in the heart, each of the two narrow strips 2132 may be, advantageously, at or near commissures 37. The amount of leaflet tissue between the open edges of the leaflets and MV annulus 36 is the lowest at commissures 37. As such, using split bridge 2132 reduces the amount of leaflet tissue between the MV annulus and the bridge, which contributes to a more secure anchoring of the AMCA system in the heart. In addition, because there is more variability between individuals in dimensions of leaflet tissue compared to dimensions of MV annulus 36, reducing the amount of leaflet tissue between bridge 2130 and the MV annulus advantageously reduces variability in the dimensions of heart tissue contacting the AMCA system at and/or near the MV after deployment.

[0058] In the description and claims of the present application, each of the verbs, "comprise" "include" and "have", and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

[0059] Descriptions of embodiments of the disclosure in the present application are provided by way of example and are not intended to limit the scope of the disclosure. The described embodiments comprise different features, not all of which are required in all embodiments of the disclosure. Some embodiments utilize only some of the features or possible combinations of the features. Variations of embodiments of the disclosure that are described, and embodiments of the disclosure comprising different combinations of features noted in the described embodiments, will occur to persons of the art. The scope of the disclosure is limited only by the claims.

Claims

1. A cardiac valve prosthesis comprising:

a prosthetic mitral valve (PMV) for replacing a native mitral valve of a subject;

a prosthetic aortic valve (PAV) for replacing a native aortic valve of the subject; and at least one bridge that couples the PAV to the PMV.

2. The cardiac valve prosthesis of claim 1, wherein

the PMV comprises a first wire mesh scaffold and a first set of prosthetic leaflets mounted to the first scaffold; and

the PAV comprises a second wire mesh scaffold and a second set of prosthetic leaflets mounted to the second scaffold.

3. The cardiac valve prosthesis of claim 2, wherein the at least one bridge comprises a wire mesh.

4. The cardiac valve prosthesis of claim 3, wherein the at least one bridge is integrally formed with the first and second wire mesh scaffolds.

5. The cardiac valve prosthesis of claim 3, wherein at least one of the first and second wire mesh scaffolds is formed separately from the at least one bridge and the at least one bridge is bonded to the at least one separately formed scaffold.

6. The cardiac valve prosthesis of claim 1, wherein the at least one bridge comprises two bridges.

7. The cardiac valve prosthesis of claim 6, wherein the two bridges are configured to grip the anterior leaflet between them when the prosthesis is deployed.

8. The cardiac valve prosthesis of claim 1, wherein the PAV, the PMV and the at least one bridge are configured to grip cardiac tissue located between the mitral valve and the aortic valve when the prosthesis is deployed.

9. The cardiac valve prosthesis of claim 8, wherein, when deployed in a heart of a subject, an outer surface of the at least one bridge or a combination of the at least one bridge and the PMV forms an inlet contoured to fit around and grip a free edge of a native anterior mitral valve leaflet.

10. A transcatheter method of replacing two cardiac valves in a same procedure, the method comprising:

guiding a distal end of a tube to the left atrium of a heart of a subject via an artery, the aortic valve, the left ventricle and the mitral valve, the tube having a cardiac valve prosthesis loaded in a collapsed state in a lumen of the tube near a distal end of the tube;

ejecting a first portion of the cardiac valve prosthesis from the distal end at the native mitral valve of the heart to expand from the collapsed state to form a prosthetic mitral valve (PMV) in the heart;

ejecting a second portion of the cardiac valve prosthesis from the distal end in the left ventricle to form at least one bridge connected to the PMV;

ejecting a third portion of the cardiac valve prosthesis from the distal end at the native aortic valve to expand from the collapsed state to form a prosthetic aortic valve (PAV) in the heart that is connected to the PMV via the at least one bridge.

11. A transcatheter method of replacing two cardiac valves in a same procedure, the method comprising:

guiding a distal end of a tube to an aorta of a subject via a vein, the right atrium, a puncture in an interatrial septum, the left atrium, the mitral valve, the left ventricle, and the aortic valve, the tube having a cardiac valve prosthesis loaded in a collapsed state in a lumen of the tube near the distal end;

ejecting a first portion of the cardiac valve prosthesis from the distal end at the native aortic valve of the heart to expand from the collapsed state to form a prosthetic aortic valve (PAV) in the heart;

ejecting a second portion of the cardiac valve prosthesis from the distal end in the left ventricle to form at least one bridge connected to the PAV;

ejecting a third portion of the cardiac valve prosthesis from the distal end at the native mitral valve of the heart to expand from the collapsed state to form a prosthetic mitral valve (PMV) in the heart that is connected to the PAV via at least one bridge.