Prosthetic heart valve

Abstract

A prosthetic valve (22, 222) configured for transcatheter implantation is provided, the prosthetic valve (22, 222) comprising a prosthetic valve frame and a plurality of prosthetic leaflets (140). The prosthetic valve frame includes a plurality of struts and is shaped to define a plurality of intermediate nodes (30, 230) that are intermediate proximal and distal ends (26, 28) of the prosthetic valve frame. A part of the plurality of struts is an intermediate strut (40). Each intermediate node (30, 230) has at least four struts extending therefrom, including (a) a pair of distally extending two struts (44) of the at least four struts, and (b) a pair of proximally extending two struts (46) of the at least four struts. Other embodiments are also described.

Description

[0001] Cross - reference to related applications

[0002] This application claims the priority of U.S. Provisional Application No. 63 / 403,965, filed on September 6, 2022, which is assigned to the assignee of this application and incorporated herein by reference. Technical field

[0003] Certain embodiments of the present invention generally relate to valve replacement. More specifically, certain embodiments of the present invention relate to artificial valves for replacing heart valves. Background art

[0004] Aortic regurgitation (AR), also known as aortic insufficiency (AI), refers to the leakage of the heart's aortic valve, resulting in blood flowing backward from the aorta into the left ventricle during ventricular diastole. As a result, the myocardium is forced to work overloaded compared to normal. Transcatheter aortic valve replacement (TAVR) is a treatment method for aortic regurgitation and stenosis.

[0005] The PCT application WO 2019 / 026059 by Hariton et al. describes a frame assembly including: a tubular portion defining a lumen along an axis; a plurality of arms coupled to the tubular portion at a first axial position, each arm extending radially outward from the tubular portion to a corresponding arm tip; and a plurality of ventricular legs horizontally coupled to the tubular portion at a second axial position and extending radially outward from the tubular portion. The first sheet has a larger perimeter edge and a smaller perimeter edge defining an opening. The first sheet is fixed to the plurality of arms by suturing, and the opening is aligned with the lumen. Subsequently, the outer edge of the second sheet is sutured to the larger perimeter edge of the first sheet, and eversion is achieved by passing the inner edge of the second sheet around the arm ends.

[0006] The PCT application WO 2023 / 009379 by Bukin et al. describes an annular frame for an artificial heart valve, which includes commissures that are radially offset and / or radially flexible relative to the rest of the frame. The commissures can extend radially outward from the rest of the frame such that the radius of their position is greater than that of the adjacent struts of the frame. The commissures can project from the frame in a cantilevered manner such that the commissures have only one axial end connected to the rest of the frame, thereby allowing the commissures to bend radially inward and outward relative to the rest of the frame. Side arms can also couple the upper end of the commissure to an adjacent apex to achieve adduction in a larger diameter state. The radial position of the commissures relative to the rest of the frame affects the positioning of the leaflets and the performance of the valve.

[0007] U.S. Patent Application Publication No. 2022 / 0031454 to Straubinger et al. describes a method of implanting a stent-containing implant at the native heart valve location, which includes: positioning the expandable body of the stent according to the blood flow direction such that the first open end of the stent is upstream of the second open end of the stent with respect to the blood flow direction through the native heart valve. The native heart valve includes native leaflets and an annulus. The method further includes radially expanding a plurality of positioning arches disposed at the periphery of the expandable body. The method further includes inserting the plurality of positioning arches into a plurality of pockets defined by the leaflets of the native heart valve and the cardiac structure extending from the native leaflets, respectively. The method further includes radially expanding the first open end of the stent to a position upstream of the annulus such that it does not contact the nerve bundle. Summary of the Invention

[0008] In certain embodiments, an artificial valve having an artificial valve frame assembly is provided. The artificial valve frame assembly includes an inner frame and an outer frame. The artificial valve can be percutaneously delivered to the native heart valve in a compressed state and expanded at the native valve to facilitate unidirectional fluid flow from inflow to outflow, from upstream to downstream, in a proximal-to-distal direction through the lumen. The artificial valve is typically designated for implantation in the native aortic valve of a patient. It should be noted that the scope of the present invention includes implanting the artificial valve in other native heart valves of a patient, such as the pulmonary valve, mitral valve, or tricuspid valve.

[0009] The outer frame of the artificial valve includes at least four pairs (e.g., six pairs) of outer frame struts and at least four (e.g., six) outer frame joints. These joints act as tissue locators for locating and identifying tissue on the downstream surface of the native valve (e.g., tissue on the downstream surface of the native commissures of the native leaflets). The paired outer frame struts serve as tissue anchors to anchor the native leaflets between the respective pairs of outer frame struts and the inner frame, thereby fixing the artificial valve by clamping the native valve tissue between the inner and outer frames. The paired outer frame struts can prevent the artificial valve from shifting proximally (in the left ventricular direction). Since the anchoring mechanism mainly relies on this clamping action, the artificial valve basically does not need to rely on outward radial forces to assist in anchoring, that is, it does not require anchoring by dimensional interference. This clamping-based anchoring method can reduce the risk of the need for implanting a permanent cardiac pacemaker by reducing the mechanical pressure exerted by the artificial valve on the conduction system around the aortic annulus.

[0010] (In some configurations, the artificial valve includes an upstream cuff, which can help prevent paravalvular leakage (PVL). Although the upstream portion of the artificial valve frame can exert an outward radial force on the surrounding aortic tissue, this radial force is mainly used to enhance the seal between the upstream cuff and the surrounding aortic tissue, rather than substantially assisting in anchoring.)

[0011] Thus, according to an embodiment of the present invention, there is provided a transcatheter implantable artificial valve, the artificial valve comprising:

[0012] An artificial valve frame that defines a lumen around the central longitudinal axis of the artificial valve when the artificial valve is in a deployed state; and

[0013] A plurality of artificial leaflets located within the lumen and arranged to promote unidirectional flow of fluid through the lumen from inflow to outflow in a proximal-to-distal direction when the artificial valve is in a deployed state;

[0014] Wherein the artificial valve frame:

[0015] Comprises a plurality of struts, and

[0016] Its shape defines a plurality of intermediate nodes located between the proximal and distal ends of the artificial valve frame,

[0017] Wherein a portion of the plurality of struts are intermediate struts,

[0018] Wherein each intermediate node has at least four struts extending therefrom, the at least four struts including (a) a pair of two struts extending distally among the at least four struts, and (b) a pair of two struts extending proximally among the at least four struts,

[0019] Wherein, for each pair of circumferentially adjacent intermediate nodes:

[0020] (i) A first distally extending strut extending from one intermediate node of the pair of intermediate nodes converges with (ii) a second distally extending strut extending from the other intermediate node of the pair of intermediate nodes at a distal joint,

[0021] (i) A first proximally extending strut extending from one intermediate node of the pair of intermediate nodes converges with (ii) a second proximally extending strut extending from the other intermediate node of the pair of intermediate nodes at a proximal joint, and

[0022] (i) A first intermediate strut extends proximally from an intermediate position of the first distally extending strut, and (ii) a second intermediate strut extends proximally from an intermediate position of the second distally extending strut, the intermediate position of the first distally extending strut being between an intermediate node and the distal joint, and the intermediate position of the second distally extending strut being between another intermediate node and the distal joint,

[0023] Wherein the first and second intermediate struts converge at an intermediate joint in the proximal direction,

[0024] Wherein the intermediate joint is located between the distal joint and the proximal joint, and

[0025] Among them, the intermediate joint, the distal joint, and the proximal joint are circumferentially aligned.

[0026] In some embodiments, when the prosthetic valve is in the expanded state, for each pair of circumferentially adjacent intermediate nodes:

[0027] The smaller rhombus of the prosthetic valve frame is defined by (1) the distal portions of the first and second distally extending struts and (2) the first and second intermediate struts, and

[0028] The larger rhombus of the prosthetic valve frame is defined by (1) the first and second distally extending struts and (2) the first and second proximally extending struts, and

[0029] The smaller rhombus is located within the larger rhombus.

[0030] In some embodiments, the first and second intermediate struts have respective continuous longitudinal sections, which, when the prosthetic valve is in the expanded state:

[0031] Respectively extend from the corresponding upstream sides of the first and second distally extending struts at an angle of 75 - 105 degrees,

[0032] Bend upstream along respective first curved longitudinal section portions of the first and second intermediate struts, and part of them bend towards their respective nearest intermediate nodes, and

[0033] Bend upstream along respective second curved longitudinal section portions of the first and second intermediate struts, and part of them bend away from their respective nearest intermediate nodes.

[0034] In some embodiments, each first curved longitudinal section has a length of 0.2 - 0.75 millimeters, and each second curved longitudinal section has a length of 1 - 1.75 millimeters, and these lengths are measured along the respective bending center longitudinal axes of the curved longitudinal sections.

[0035] In some embodiments:

[0036] Each first curved longitudinal section has a first length, and each second curved longitudinal section has a second length, and these lengths are measured along the respective bending center longitudinal axes of the curved longitudinal sections, and

[0037] The ratio of the second length to the first length is 2 - 8.

[0038] In some embodiments, each first curved longitudinal section has a first inner curvature radius of 0.05 - 0.2 millimeters, and each second curved longitudinal section has a second inner curvature radius of 0.4 - 0.8 millimeters.

[0039] In some embodiments:

[0040] Each first curved longitudinal section has a first inner curvature radius, each second curved longitudinal section has a second inner curvature radius, and

[0041] The ratio of the second inner curvature radius to the first inner curvature radius is 2 - 10.

[0042] In some embodiments, when the prosthetic valve is in the expanded state, the total height of the prosthetic valve frame is 20 - 26 millimeters.

[0043] In some embodiments:

[0044] Each intermediate node has at least six struts extending therefrom,

[0045] The two struts extending proximally in opposition define the first two struts extending proximally in opposition among the at least six struts,

[0046] The at least six struts include a second two struts extending proximally in opposition among the at least six struts,

[0047] The proximal joint defines a first proximal joint, and

[0048] For each pair of circumferentially adjacent intermediate nodes:

[0049] (i) A third proximally extending strut extending from one intermediate node of the pair of intermediate nodes converges at a second proximal joint with (ii) a fourth proximally extending strut extending from the other intermediate node of the pair of intermediate nodes,

[0050] The third proximally extending strut is proximal to the first proximally extending strut,

[0051] The fourth proximally extending strut is proximal to the second proximally extending strut,

[0052] The second proximal joint is close to the first proximal joint, and

[0053] The first and second proximal joints are circumferentially aligned.

[0054] In some embodiments, when the prosthetic valve is in the expanded state, for each pair of circumferentially adjacent intermediate nodes:

[0055] The smaller rhombus of the prosthetic valve frame is defined by (1) the distal portions of the first and second distally extending struts and (2) the first and second intermediate struts,

[0056] The boundary of the larger rhombus of the prosthetic valve frame is formed by (1) the first and second distally extending struts and (2) the first and second proximally extending struts, and

[0057] The largest rhombus of the prosthetic valve frame is defined by (1) a first and a second distally extending strut and (2) a third and a fourth proximally extending strut, and

[0058] A smaller rhombus is located within the larger rhombus, and the larger rhombus is located within the largest rhombus.

[0059] In some embodiments:

[0060] This portion of the plurality of struts includes a first portion of the plurality of struts,

[0061] The prosthetic valve frame includes a second portion of the plurality of struts,

[0062] The second portion of the plurality of struts is a proximal strut, and

[0063] For each intermediate node:

[0064] (i) A first proximal strut extends proximally from an intermediate position of the first of two proximally extending struts of a second pair among at least six struts, and (ii) a second proximal strut extends proximally from an intermediate position of the second of two proximally extending struts of the second pair among at least six struts, the respective intermediate positions of the first and second struts of the second pair of proximally extending struts being located between the intermediate node and the respective proximal ends of each of the first and second struts of the second pair of proximally extending struts,

[0065] The first and second proximal struts converge at a proximally directed junction of the first and second proximal struts,

[0066] The proximally directed junction of the first and second proximal struts is circumferentially aligned with the intermediate node, and

[0067] The proximally directed junction is circumferentially offset relative to the second proximal junction.

[0068] In some embodiments, the proximally directed junction is longitudinally aligned with a second proximal junction at the proximal end of the prosthetic valve frame.

[0069] In some embodiments:

[0070] Each intermediate node has at least eight struts extending therefrom,

[0071] The two distally extending struts of the pair are the first pair of two distally extending struts among at least eight struts, and

[0072] For each pair of circumferentially adjacent intermediate nodes:

[0073] (i) A third distally extending strut extending from one intermediate node of the pair of intermediate nodes and (ii) a fourth distally extending strut extending from the other intermediate node of the pair of intermediate nodes converge at a distal junction.

[0074] The third distal extension strut is located at the distal end of the first distal extension strut, and

[0075] The fourth distal extension strut is located at the distal end of the second distal extension strut.

[0076] According to an embodiment of the present invention, there is also provided an artificial valve for transcatheter implantation, the artificial valve comprising:

[0077] An artificial valve frame that surrounds the central longitudinal axis of the artificial valve and defines a lumen along the axis when the artificial valve is in the expanded state; and

[0078] A plurality of artificial leaflets located within the lumen and arranged to facilitate unidirectional fluid flow from proximal to distal through the lumen when the artificial valve is in the expanded state,

[0079] wherein the artificial valve frame:

[0080] Has a proximal end at the inflow end of the artificial valve frame,

[0081] Has a distal end at the outflow end of the artificial valve frame,

[0082] Includes a plurality of struts,

[0083] Shaped to define a plurality of distal nodes located at the distal end of the frame, and

[0084] Shaped to define a plurality of intermediate nodes that (1) are located between the proximal and distal ends of the artificial valve frame and (2) are circumferentially offset relative to the distal nodes,

[0085] wherein a portion of the plurality of struts are reinforcing struts,

[0086] wherein each intermediate node has at least four struts extending therefrom, including (a) a pair of two struts extending distally among the at least four struts, and (b) a pair of two struts extending proximally among the at least four struts,

[0087] wherein (i) a first reinforcing strut extends proximally from an intermediate position of the first of the pair of two struts extending distally, and (ii) a second reinforcing strut extends proximally from an intermediate position of the second of the pair of two struts extending distally, the intermediate positions of the first and second of the pair of two struts extending distally being respectively located between the intermediate node and the respective distal ends of each of the pair of two struts extending distally,

[0088] wherein the first and second reinforcing struts converge at a proximal pointing joint of the first and second reinforcing struts, and

[0089] Wherein (1) the proximal joints of the first and second reinforcing struts and (2) the intermediate nodes are circumferentially aligned.

[0090] In certain embodiments, when the prosthetic valve is in the expanded state, the overall height of the prosthetic valve frame is 20-26 millimeters.

[0091] In certain embodiments:

[0092] Each distal node has at least two struts extending therefrom, the at least two struts including a pair of struts extending proximally from the distal node, and for each pair of circumferentially adjacent distal nodes:

[0093] The first strut extending proximally from one distal node of the pair and (ii) the second strut extending proximally from the other distal node of the pair converge at the outflow joint, and

[0094] (1) the outflow joint, (2) the proximal joints of the first and second reinforcing struts, and (3) the corresponding intermediate nodes are circumferentially aligned.

[0095] In certain embodiments:

[0096] Each distal node has at least four struts extending therefrom,

[0097] A pair of struts extending proximally from the distal node defines a pair of struts extending proximally from the first distal node,

[0098] At least four struts of the distal node include a second pair of struts extending proximally from the distal node, and

[0099] The outflow joint defines a first outflow joint, and for each pair of circumferentially adjacent distal nodes:

[0100] The strut extending proximally from the third distal node of one distal node of the pair meets the strut extending proximally from the third distal node of the other distal node of the pair at the second outflow joint, and

[0101] The first and second outflow joints are circumferentially aligned.

[0102] In certain embodiments:

[0103] Each distal node has at least five struts extending therefrom, and

[0104] At least five struts include a vertical strut that extends proximally from the distal node located between (1) the struts extending proximally from the first and third distal nodes and (2) the struts extending proximally from the second and fourth distal nodes.

[0105] In some embodiments, the first and second outflow connectors meet at an outflow node.

[0106] According to an embodiment of the present invention, there is also provided an artificial valve for transcatheter implantation, the artificial valve comprising:

[0107] An artificial valve frame assembly, comprising:

[0108] An inner frame that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in a deployed state; and an outer frame coupled to the inner frame and surrounding the inner frame,

[0109] wherein the inner frame includes a plurality of inner frame struts arranged in a double-strut form, wherein two inner frame struts are arranged side by side with each other, and

[0110] wherein the outer frame includes a plurality of outer frame struts arranged in a multi-strut form, wherein two or more outer frame struts are arranged side by side with each other; and

[0111] A plurality of artificial leaflets disposed within the lumen of the inner frame and configured to facilitate one-way flow of fluid from inflow to outflow when the artificial valve is in a deployed state.

[0112] In some embodiments, when the artificial valve is in a deployed state, the overall height of the artificial valve frame is 20-26 millimeters.

[0113] In some embodiments, a plurality of outer frame struts are arranged in a double-strut form, wherein two outer frame struts are arranged side by side with each other.

[0114] In some embodiments, a plurality of outer frame struts are arranged in a triple-strut form, wherein three outer frame struts are arranged side by side with each other.

[0115] According to an embodiment of the present invention, there is also provided an artificial valve for transcatheter implantation, the artificial valve comprising:

[0116] (a) An artificial valve frame assembly, comprising:

[0117] An inner frame that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in a deployed state, and the inner frame includes a plurality of inner frame struts; and

[0118] An outer frame surrounding the inner frame and including a plurality of outer frame struts; and

[0119] (b) A plurality of artificial leaflets disposed within the lumen of the inner frame and arranged to facilitate one-way flow of fluid from inflow to outflow in a proximal-to-distal direction through the lumen when the artificial valve is in a deployed state,

[0120] Wherein, the inner frame is shaped to define a plurality of pairs of inner frame struts that converge at respective inner frame joints pointing in the proximal direction, and the plurality of pairs of inner frame struts are circumferentially arranged to engage the inflow surface of the patient's native valve.

[0121] Wherein, the outer frame is shaped to define a plurality of pairs of outer frame struts that converge at respective outer frame joints pointing in the proximal direction, and the plurality of pairs of outer frame struts are circumferentially arranged to engage the outflow surface of the native valve.

[0122] Wherein, each outer frame joint is circumferentially aligned with a corresponding inner frame joint.

[0123] Wherein, the plurality of pairs of inner frame struts and the plurality of pairs of outer frame struts are configured to engage the leaflets of the native valve between corresponding pairs of inner frame struts and outer frame struts, and

[0124] Wherein, the outer frame is shaped to define at least four pairs of outer frame struts and at least four outer frame joints.

[0125] In some embodiments, when the prosthetic valve is in the expanded state, the overall height of the prosthetic valve frame is 20 - 26 millimeters.

[0126] In some embodiments, the outer frame is shaped to define at least six pairs of outer frame struts and at least six outer frame joints.

[0127] The present invention can be more fully understood from the following detailed description of embodiments of the invention in conjunction with the accompanying drawings, wherein: BRIEF DESCRIPTION OF THE DRAWINGS

[0128] Figure 1A - D is a schematic view of the inner frame of a prosthetic valve and a frame assembly of the prosthetic valve according to some embodiments of the present invention;

[0129] Figure 2A - C is a schematic view of the outer frame of a prosthetic valve and a frame assembly of the prosthetic valve according to some embodiments of the present invention;

[0130] Figure 3A - F is a schematic view of a frame assembly of a prosthetic valve according to some embodiments of the present invention;

[0131] Figure 4A - B is a schematic view of the inner frame in a compressed state according to some embodiments of the present invention;

[0132] Figure 5A - B is a schematic view of the outer frame in a compressed state according to some embodiments of the present invention;

[0133] Figure 6A-B is a schematic view of a frame component according to certain embodiments of the present invention in a compressed state;

[0134] Figure 7A -F is a schematic view of implanting an artificial valve at a patient's native aortic valve according to certain embodiments of the present invention;

[0135] Figure 8 is a schematic view of the inner frame of another artificial valve according to an embodiment of the present invention;

[0136] Figure 9 is according to an embodiment of the present invention Figure 8 schematic view of the outer frame of the artificial valve;

[0137] Figure 10 is according to certain embodiments of the present invention Figure 8 and Figure 9 schematic view of the artificial valve frame assembly of the artificial valve;

[0138] Figure 11A -B is according to the corresponding embodiment of the present invention Figure 8 schematic view of the inner frame of the artificial valve, including a skirt and artificial leaflets;

[0139] Figure 11C is according to an embodiment of the present invention Figure 10 schematic view of the artificial valve frame assembly of the artificial valve, including the skirt and artificial leaflets of FIG. 11;

[0140] Figure 12A -H is according to the corresponding embodiment of the present invention Figure 8 schematic view of an additional structure of the inner frame;

[0141] Figure 13A -B is according to the corresponding embodiment of the present invention Figure 2A schematic view of an additional structure of the outer frame of -C;

[0142] Figure 14 is a schematic view of another outer frame of an artificial valve according to an embodiment of the present invention. Detailed Embodiments

[0143] Please refer to Figure 1A-D, 2A-C, and 3A-F are schematic views of an artificial valve 22 according to certain embodiments of the present invention. The artificial valve 22 includes an artificial valve frame assembly 21 that includes an inner frame 24 and an outer frame 80. The artificial valve is for a native heart valve of a subject - typically the aortic valve. The artificial valve has a compressed state and a deployed state. The compressed state is for minimally invasive (typically trans-luminal, e.g., transfemoral) delivery and is converted to the deployed state at the native heart valve, in which state the artificial valve 22 provides artificial valve function. The artificial valve 22 includes an artificial valve frame assembly 21, a skirt 300 formed of a flexible sheet (such as the artificial valve 222 described below with reference to Figure 11A -C), and a valve member that includes artificial leaflets 140.

[0144] Figure 1A -D, 2A-C, and 3A-F show the artificial valve 22 and its frame in the deployed state. For clarity, Figure 1A the inner frame 24 of the frame assembly 21 is shown separately in an isometric view and a side view, while Figure 1B the inner frame 24 is shown separately in a side view with fewer reference numerals in the figure for clarity. For clarity, Figure 1A an enlarged portion of Figure 1B and the whole Figure 1C show a circumferential half-side of the inner frame 24. Figure 1D shows a top outflow view of the inner frame 24. Figure 2A the outer frame 80 of the frame assembly 21 is shown separately in an isometric view and a side view. Figure 2B shows a planar expanded view of the outer frame 80. Figure 2C shows a top outflow view of the outer frame 80. For clarity, Figure 2A an enlarged portion of Figure 3C and 3D the whole show a circumferential half-side of an enlarged portion of the artificial valve 22.

[0145] For clarity of illustration, Figure 1A - 3D the artificial leaflets 140 are omitted, although the artificial valve 22 actually includes the artificial leaflets 140. Optionally, the artificial valve 22 may further include a skirt 300 and / or an upstream cuff 310, as described below with reference to Figure 11A -C for the artificial valve 222.

[0146] The prosthetic valve 22, as well as the inner frame 24 and the outer frame 80, each have an upstream proximal end 26 and a downstream distal end 28, and define a central longitudinal axis ax1 therebetween. The frame assembly 21 includes a prosthetic valve frame that includes a valve body (which is generally a tubular portion) and is shaped to define a lumen that passes through the valve body from its upstream end to its downstream end. The valve body surrounds the axis ax1, thereby defining a lumen along the axis. Throughout this application, including the specification and claims, unless otherwise indicated, "upstream" and "downstream", e.g., with respect to the two ends of the prosthetic valve 22, are defined by the orientation and function of the prosthetic valve leaflets with respect to the longitudinal axis of the valve 22, which facilitates unidirectional fluid flow from upstream to downstream in the proximal-to-distal direction through the lumen. Throughout this application, including the specification and claims, unless otherwise indicated, "proximal" and "distal", e.g., with respect to the two ends of the prosthetic valve 22, are defined by the orientation and function of the prosthetic valve leaflets with respect to the longitudinal axis of the valve 22, which facilitates unidirectional fluid flow from upstream to downstream in the proximal-to-distal direction through the lumen.

[0147] Figure 2A -C shows the outer frame 80. The outer frame 80 includes appendages 81 configured to reversibly couple the prosthetic valve 22 to a delivery tool. The total height H1 of the frame assembly 21 is 20 - 26 mm, e.g., 22.0 - 24.83 mm. H1 does not include the appendages 81. H1 generally also represents the height of the inner frame 24. Thus, compared to other aortic valves in the field of aortic valve replacement, the total height H1 of the prosthetic valve 22 of the present invention is shorter than that of conventional transcatheter aortic valves. According to the inventors' speculation, the reduced overall height H1 can minimize or even eliminate interference with the openings 124 and 126 of the coronary arteries 123 and 125 and shorten the supra-annular portion 92 of the prosthetic valve 22.

[0148] Figure 1A -D shows the inner frame 24. It should be noted that the inner frame 24 is generally used in combination with Figure 2A -the outer frame 80 shown in -C, and generally so in this text. However, it should be noted that the scope of the present invention includes (1) using the inner frame 24 alone, i.e., without an outer frame, or (2) using it in combination with any other suitable valve frame, such as a suitable additional outer frame or a suitable additional inner frame.

[0149] The inner frame 24 of the prosthetic valve includes a plurality of struts made of a biocompatible material (such as nitinol). The inner frame 24 is shaped to define a plurality of intermediate nodes 30 that are located between the proximal end 26 and the distal end 28 of the inner frame 24. The inner frame 24 of the prosthetic valve is shaped to define a plurality of distal nodes 32 that are located at the distal end 28 of the inner frame 24. The intermediate nodes 30 are circumferentially offset relative to the distal nodes 32.

[0150] The first part of the plurality of struts of the inner frame 24 is the intermediate strut 40. Each intermediate node 30 has at least four struts extending therefrom, for example, at least six struts (e.g., exactly six struts), as shown in Figure 1A -D and 3A-D, or at least eight struts (e.g., exactly eight struts), as described below in Figure 8 , 10 , 11A-C and 12. The struts extending from each intermediate node 30 include (a) a pair of two struts 44 extending distally among at least four struts, and (b) a pair of two struts 46 extending proximally among at least four struts. Optionally, each intermediate node 30 is shaped to define a waist that axially separates the ends of the two struts 44 extending distally from the ends of the two struts 46 extending proximally; for example, the length of the waist can be 0.1-0.3 mm, such as 0.12-0.2 mm, for example 0.15 mm.

[0151] Refer to Figure 1A -C. For each pair of circumferentially adjacent intermediate nodes 30, for example:

[0152] · (i) The first distally extending strut 44a extending from one intermediate node 30a of a pair of intermediate nodes 30 converges at the distal joint 45 with (ii) the second distally extending strut 44b extending from the other intermediate node 30b of the pair of intermediate nodes 30,

[0153] · (i) The first proximally extending strut 46a extending from one intermediate node 30a of the pair of intermediate nodes 30 converges at the proximal joint 48a with (ii) the second proximally extending strut 46b extending from the other intermediate node 30b of the pair of intermediate nodes 30, and

[0154] · Optionally, (i) the first intermediate strut 40a extends proximally from an intermediate position 39a on the first distally extending strut 44a, and (ii) the second intermediate strut 40b extends proximally from another intermediate position 39b on the second distally extending strut 44b. The intermediate position 39a on the first distally extending strut 44a is located between an intermediate node 30a and the distal joint 45. The intermediate position 39b on the second distally extending strut 44b is located between the other intermediate node 30b and the distal joint 45.

[0155] The first intermediate strut 40a and the second intermediate strut 40b converge at an intermediate joint 42 that points in the proximal direction. The intermediate joint 42 is located between the distal joint 45 and the proximal joint 48a. The intermediate joint 42, the distal joint 45, and the proximal joint 48a are circumferentially aligned. Typically, the intermediate struts 40 and the intermediate joint 42 are disposed in the anchoring region 90 of the inner frame 24 and the prosthetic valve 22, and provide higher radial strength and rigidity for the valve 22 at the anchoring region 90.

[0156] As Figure 1A marked in, in some embodiments, for each pair of circumferentially adjacent intermediate nodes 30:

[0157] · The smaller diamond 10 (or similar shape) of the prosthetic valve inner frame 24 is defined by (1) the distal portions of the first and second distally extending struts 44a and 44b and (2) the first and second intermediate struts 40a and 40b,

[0158] · The larger diamond 12 (or similar shape) of the prosthetic valve inner frame 24 is defined by (1) the first and second distally extending struts 44a and 44b and (2) the first and second proximally extending struts 46a and 46b, and

[0159] · The smaller diamond 10 is located within the larger diamond 12.

[0160] Alternatively, the shape of the inner frame 24 does not define the first intermediate strut 40a and the second intermediate strut 40b.

[0161] Still referring to Figure 1A -C. For embodiments where each intermediate node 30 has at least six struts extending therefrom (as shown):

[0162] · The two proximally extending struts 46 of the pair are the first two proximally extending struts 46 of the at least six struts, · The at least six struts include a second pair of two proximally extending struts 50 of the at least six struts, and · The proximal joint defines a first proximal joint 48a.

[0163] For each pair of circumferentially adjacent intermediate nodes 30:

[0164] · (i) The third proximally extending strut 50a extending from one intermediate node 30a of the pair of intermediate nodes 30 converges at the second proximal joint 48b with (ii) the fourth proximally extending strut 50b extending from the other intermediate node 30b of the pair of intermediate nodes 30, · The third proximally extending strut 50a is proximal to the first proximally extending strut 46a,

[0165] · The fourth proximally extending strut 50b is proximal to the second proximally extending strut 46b,

[0166] · The second proximal joint 48b is close to the first proximal joint 48a, and

[0167] · The first and second proximal joints 48a and 48b are circumferentially aligned.

[0168] As Figure 1A shown in -C, the first proximal joint 48a, its corresponding second proximal joint 48b, its corresponding intermediate joint 42, its corresponding distal node 32, and its corresponding distal joint 45 are all circumferentially aligned. In some embodiments, as shown in the figure, (1) the third and fourth proximally extending struts 50a and 50b are connected to (2) the first and second proximally extending struts 46a and 46b at the connector 55. As shown in the figure, the connector includes a vertical metal piece. It should be noted that (1) the struts 50a and 50b and (2) the struts 46a and 46b can be connected using any suitable connector.

[0169] In some embodiments, as Figure 1A shown in -B, for each pair of circumferentially adjacent intermediate nodes 30:

[0170] · The smaller diamond 10 of the artificial inner valve inner frame 24 is defined by (1) the distal portions of the first and second distally extending struts 44a and 44b and (2) the first and second intermediate struts 40a and 40b,

[0171] · The larger diamond 12 of the artificial inner valve inner frame 24 is defined by (1) the first and second distally extending struts 44a and 44b and (2) the first and second proximally extending struts 46a and 46b, and

[0172] · The largest diamond 14 (or similar shape) of the artificial inner valve inner frame 24 is defined by (1) the first and second distally extending struts 44a and 44b and (2) the third and fourth proximally extending struts 50a and 50b.

[0173] The smaller diamond 10 is located within the larger diamond 12, and the larger diamond 12 is located within the largest diamond 14. Thus, the inner frame 24 is defined within a diamond - within - diamond portion.

[0174] The second portion of the plurality of struts of the artificial valve inner frame 24 is the proximal strut 52. Generally, the proximal strut 52 is disposed at the inflow proximal 26 of the artificial valve inner frame 24 and provides enhanced strength and rigidity to the sub - annular portion 70 of the native aortic valve. This enhanced strength and rigidity provided by the proximal strut helps to reduce or eliminate paravalvular leakage. In addition, the proximal strut 52 is combined with the longitudinally adjacent first and second proximal joints 48a and 48b (as described below with reference to Figure 3C ), and provides further enhanced strength and rigidity to the sub - annular portion 70 of the native aortic valve.

[0175] Typically, the subannular portion 70 is covered by a covering, such as fabric, polyester (e.g., Dacron(TM)), velvet cloth, an inflatable cuff that can be inflated with blood or liquid, and / or any other suitable material. Typically, the covering is fabric, such as polyester (e.g., Dacron(TM)). This covering 150 will be described below in connection with Figure 7F The height H3 of the subannular portion 70 is typically 5.4 - 6.5 mm, such as 5.4 mm.

[0176] As Figure 1A -B is marked, for each intermediate node 30:

[0177] · (i) The first proximal strut 52a extends proximally from an intermediate position 53a of the first strut 50', where the first strut 50' is one of two struts 50 that extend proximally as the second pair among at least six struts extending from the intermediate node 30, and (ii) the second proximal strut 52b extends proximally from an intermediate position 53b of the second strut 50", where the second strut 50" is the other of two struts 50 that extend proximally as the second pair among at least six struts extending from the intermediate node 30.

[0178] · Each intermediate position 53a and 53b is respectively located on the corresponding first and second struts 50' and 50" of the second pair of struts 50 that extend proximally, and these intermediate positions are located between the intermediate node 30 and the corresponding proximals of the first and second struts 50' and 50" of the second pair of struts 50 that extend proximally.

[0179] · The first and second proximal struts 52a and 52b converge at a proximally directed joint 54 of the first and second proximal struts 52a and 52b.

[0180] · The proximally directed joint 54 of the first and second proximal struts 52a and 52b is circumferentially aligned with the intermediate node 30. Each proximally directed joint 54 is circumferentially offset relative to its adjacent second proximal joint 48b.

[0181] · The proximally directed joint 54 is typically but not necessarily longitudinally aligned with the second proximal joint 48b at the proximal 26 of the prosthetic valve inner frame 24.

[0182] Still referring to Figure 1A-B. The third portions of the plurality of struts of the inner frame 24 of the prosthetic valve are reinforcing struts 56. As described above, each intermediate node 30 has at least four struts extending therefrom: (a) a pair of two struts 44 that extend distally among the at least four struts, and (b) a pair of two struts 46 that extend proximally among the at least four struts. A first reinforcing strut 56a extends proximally from an intermediate position 57a of the first strut 44' of the pair of distally extending struts 44, and (ii) a second reinforcing strut 56b extends proximally from an intermediate position 57b of the second strut 44'' of the pair of distally extending struts 44. The intermediate positions 57a and 57b of each of the first strut 44' and the second strut 44'' of the pair of distally extending struts 44 are located between the intermediate node 30 and the respective distal ends of the first strut 44' and the second strut 44'' of the pair of distally extending struts 44. The first and second reinforcing struts 56a and 56b converge at a proximally directed joint 58 of the first and second reinforcing struts. (1) The proximally directed joint 58 of the first and second reinforcing struts 56a and 56b, and (2) its corresponding intermediate node 30 are circumferentially aligned. In addition, (1) the proximally directed joint 58 of the first and second reinforcing struts 56a and 56b, (2) its corresponding intermediate node 30, and (3) its corresponding proximally directed joint 54 are circumferentially aligned.

[0183] Still referring to Figure 1A -B. Generally, the reinforcing struts 56a and 56b are located at positions on the inner frame 24 adjacent to the junction with the prosthetic leaflets 140 of the prosthetic valve 22. As shown, each of the reinforcing struts 56a and 56b is coupled to a respective distally extending strut 44. As referred to below Figure 3CAs described above, the leaflet connector 102 connects the artificial leaflets 140 of the artificial valve 22 to the inner frame 24 by suturing (i.e., sutures) to the corresponding distally extending struts 44 and other struts. The leaflet connector 102 forms the commissures of the artificial leaflets 140 of the artificial valve. Since the reinforcing struts 56a and 56b are coupled to the corresponding distally extending struts 44, the reinforcing struts 56a and 56b reinforce this location, thereby reinforcing the adjacent artificial commissures of the artificial valve 22. In addition, the reinforcing struts 56a and 56b also enhance, reinforce, and provide further rigidity to each distally extending strut 44. Thus, each pair of reinforcing struts 56a and 56b forms a corresponding reinforcement region 100 of the artificial valve 22. As shown, in the region 100, the artificial valve 22 defines a semi-double strut region of the artificial valve 22. Such a semi-double strut region is particularly suitable for regions where the density is increased due to the presence of the leaflet connector 102 of the artificial valve 22. Thus, in order to accommodate the reduced space due to the leaflet connector 102 of the artificial leaflets 140, smaller reinforcing struts 56 are used in the region 100 compared to the other struts of the valve 22. Typically, the length of each reinforcing strut 56 is 20 - 80%, such as 30 - 60%, of the length of each intermediate strut 40. In addition, the relatively short length of each reinforcing strut 56 provides greater rigidity compared to the longer struts. According to the inventors' speculation, the reinforcing struts 56 are particularly suitable for accommodating the radial forces of the left ventricular outflow tract.

[0184] Still referring to Figure 1A -B. Each distal node 32 has at least two struts extending therefrom, which includes a pair of two struts 62 extending proximally from the distal node. For each circumferentially adjacent pair of distal nodes 32:

[0185] · The first distal node proximally extending strut 62a extending from one distal node 32a of the pair of distal nodes 32 converges at the first outflow joint 64a with (ii) the second distal node proximally extending strut 62b extending from the other distal node 32b of the pair of distal nodes 32, and

[0186] · (1) The first outflow joint 64a, (2) the proximal pointing joints 58 of the first and second reinforcing struts 56a and 56b, and (3) the corresponding intermediate node 30 are circumferentially aligned.

[0187] Each distal node 32 has at least four struts extending therefrom. A pair of two struts 62 extending proximally from the distal node defines a first pair of two struts 62 extending proximally from the distal node, and at least four struts of the distal node 32 include a second pair of two struts 66 extending proximally from the distal node.

[0188] Still referring to Figure 1A -B. For each circumferentially adjacent pair of distal nodes 32:

[0189] · A third distal node proximal extension strut 66a extending from one of the pair of distal nodes 32, a distal node 32a, converges at a second outflow joint 64b with (ii) a third distal node proximal extension strut 66b extending from the other distal node 32b of the pair of distal nodes, and

[0190] · The first and second outflow joints 64a and 64b are circumferentially aligned.

[0191] As Figure 1A -B shows, the proximal joints 58 of the first and second reinforcing struts 56a and 56b pointing, (2) their corresponding intermediate nodes 30, (3) their corresponding proximal joints 54 pointing are circumferentially aligned, and their corresponding first and second outflow joints 64a and 64b are circumferentially aligned.

[0192] As Figure 1A -B shows, each distal node 32 has at least five struts extending therefrom. The at least five struts include a vertical strut 60 which extends proximally from the distal node 32 towards the distal joint 45 and is located between (1) the first and third distal node proximal extension struts 62a and 66a and (2) the second and fourth distal node proximal extension struts 62b and 66b.

[0193] The struts at the outflow distal end of the inner frame 24 can be described as arranged in a double-strut form, where each pair of inner frame distal struts (i.e., two struts 62 extending from a pair of distal nodes proximally and two struts 66 extending from a second pair of distal nodes proximally) are arranged side by side with each other. The double-strut structure at the outflow distal end 28 of the inner frame 24 defines the distal perimeter of the inner frame 24 and is arranged in a wavy or zigzag pattern between circumferentially adjacent distal nodes 32 in the form of a series of rising and falling struts. According to the inventors' speculation, the double-strut structure may provide radial strength and rigidity to the outflow distal end of the inner frame 24 and the artificial valve 22. In addition, the double-strut structure of the inner frame 24 enhances the strength of the inner frame 24 such that it does not deform due to hydrodynamic forces and other forces exerted by the native tissue on the artificial valve 22.

[0194] As Figure 1A -B shows, the second proximal joint 48b extends further radially from the axis ax1 than the distal node 32, such that the proximal end 26 of the inner frame 24 is wider than the distal end 28 of the inner frame 24. The diameter of the inner frame 24 gradually decreases in a tapered manner from the proximal end 26 to the distal end 28.

[0195] As Figure 1A -B shows and in Figure 1BAs identified in, the first and second intermediate struts 40a and 40b have respective continuous longitudinal sections. In some embodiments, when the prosthetic valve is in the expanded state, the respective continuous longitudinal sections:

[0196] @extend from the respective upstream sides of the first and second distally extending struts 44a and 44b at an angle α (alpha) of 75 - 105 degrees, such as 85 - 95 degrees, such as 90 degrees,

[0197] ·partially bend upstream and partially bend towards their respective nearest intermediate nodes 30a and 30b (along the respective first curved longitudinal sections 41 of the first and second intermediate struts 40a and 40b), and

[0198] ·partially bend upstream and partially bend away from their respective nearest intermediate nodes 30a and 30b (along the respective second curved longitudinal sections 43 of the first and second intermediate struts 40a and 40b).

[0199] Optionally, only one of the first and second intermediate struts 40a and 40b of each pair of circumferentially adjacent intermediate nodes 30 has the above shape.

[0200] For each intermediate strut 40a and 40b, the end of the first curved longitudinal section 41 and the start of the second curved longitudinal section 43 are defined by the inflection point between the first curved longitudinal section 41 and the second curved longitudinal section 43. For each intermediate strut 40a and 40b, the end of the second curved longitudinal section 43 is defined by (a) the inflection point along the intermediate strut or (b) the point where the intermediate strut straightens.

[0201] For example, the length of each first curved longitudinal section 41 can be at least 0.2 mm (e.g., at least 0.25 mm), not more than 0.75 mm (e.g., not more than 0.6 mm) and / or 0.2 - 0.75 mm (e.g., 0.25 - 0.6 mm). Additionally, or for example, the length of each second curved longitudinal section 43 can be at least 1 mm (e.g., at least 1.1 mm), not more than 1.75 mm (e.g., not more than 1.5 mm) and / or 1 - 1.75 mm (e.g., 1.1 - 1.5 mm). These lengths are measured along the respective curved center longitudinal axes of the curved longitudinal sections. Further alternatively or additionally, for example, the ratio of the length of each second curved longitudinal section 43 to the length of each first curved longitudinal section 41 can be 1.5 - 10, such as 2 - 8, for instance 2 - 6.

[0202] For example, each first curved longitudinal section 41 can have a first inner curvature radius R of at least 0.05 mm (e.g., at least 0.06 mm), not greater than 0.2 mm (e.g., not greater than 0.16 mm) and / or 0.05 - 0.2 mm (e.g., 0.06 - 0.16 mm)C1 Alternatively, for example, each second curved longitudinal section 43 may have a second inner curvature radius R of at least 0.4 mm (e.g., at least 0.5 mm), not greater than 0.8 mm (e.g., not greater than 0.7 mm), and / or 0.4 - 0.8 mm (e.g., 0.5 - 0.7 mm). C2 In addition, or for example, the second inner curvature radius R C2 and the first inner curvature radius R C1 may have a ratio of 2 - 10, e.g., 3 - 9.

[0203] The shape of the above-mentioned bent portions of the first and second intermediate struts 40a and 40b may contribute to (a) providing a lower crimp profile and / or (b) creating an optimal curvature for these struts such that when these struts meet at the intermediate joint 42, these struts can be sutured to the upstream portion of the artificial valve leaflet without applying tension to the leaflet or folding the leaflet ( Figure 11A -C shows such a suturing manner of the artificial valve 222).

[0204] Figure 2A -C shows the outer frame 80 of the artificial valve 22. In some embodiments, as shown, the outer frame 80 includes appendages 81 configured to reversibly couple the artificial valve 22 to a delivery tool. The height H2 of the outer frame 80 is 12 - 17 mm, e.g., 13.3 - 15.9 mm. The height H2 does not include the appendages 81. In some embodiments, the wall thickness of the outer frame 80 is less than the wall thickness of the inner frame 24, which reduces the crimp profile of the artificial valve 22 when it is within the delivery tube. Alternatively, in some embodiments, the inner frame 24 includes the appendages 81 instead of the outer frame 80, or as a supplement to the outer frame 80 (the structure of which is not shown). Whether the inner frame 24 or the outer frame 80 includes the appendages 81, the appendages extend distally beyond the distal end 28 of the corresponding frame, i.e., are not considered part of the corresponding frame and thus are not included in the corresponding height of the corresponding frame.

[0205] The outer frame 80 of the artificial valve includes a plurality of struts made of a biocompatible material, such as nitinol. The outer frame 80 is shaped to define a plurality of intermediate nodes 86 located between the proximal and distal ends 26 and 28 of the outer frame 80. The outer frame 80 of the artificial valve is also shaped to define a plurality of distal nodes 88 located at the distal end 28 of the outer frame 80. The intermediate nodes 86 are circumferentially offset relative to the distal nodes 88.

[0206] Reference Figure 2A Each intermediate node 86 has at least four struts extending therefrom, e.g., at least eight struts (e.g., exactly eight struts), as Figure 2A -B and 3A - D (and as described below Figure 14, 21, 22, and 23), or at least 12 struts (e.g., exactly 12 struts), as Figure 9 and 10 shown and described below. The struts extending from each intermediate node 86 include (a) a pair of two distally extending struts 87 (87a and 87b) out of at least four struts, and (b) a pair of two proximally extending struts 85 (85a and 85b) out of at least four struts.

[0207] For embodiments where each intermediate node 86 has at least eight struts extending therefrom (as shown), the struts extending from each intermediate node include (a) a first pair of two distally extending struts 87 (87a and 87b) out of at least eight struts, (b) a second pair of two distally extending struts 89 (89a and 89b) out of at least eight struts, (c) a first pair of two proximally extending struts 85 (85a and 85b) out of at least eight struts, and (d) a second pair of two proximally extending struts 83 (83a and 83b) out of at least eight struts.

[0208] Still referring to Figure 2A . For each pair of circumferentially adjacent intermediate nodes 86 of the outer frame 80, e.g.:

[0209] · (i) A first distally extending distal strut 87a extending from one intermediate node 86a of a pair of intermediate nodes 86 converges with (ii) a second distally extending distal strut 87b extending from the other intermediate node 86b of the pair of intermediate nodes 86 at a distal node 88, and

[0210] · (i) A first proximally extending proximal strut 85a extending from one intermediate node 86a of the pair of intermediate nodes 86 converges with (ii) a second proximally extending proximal strut 85b extending from the other intermediate node 86b of the pair of intermediate nodes 86 at a first outer frame proximal joint 94. Additionally, as Figure 2A shown, for each pair of circumferentially adjacent intermediate nodes 86 of the outer frame 80, e.g.:

[0211] · (i) A third distally extending distal strut 89a extending from one intermediate node 86a of the pair of intermediate nodes 86 converges with (ii) a fourth distally extending distal strut 89b extending from the other intermediate node 86b of the pair of intermediate nodes 86 at a distal node 88, and

[0212] · (i) A third proximally extending proximal strut 83a extending from one intermediate node 86a of the pair of intermediate nodes 86 converges with (ii) a fourth proximally extending proximal strut 83b extending from the other intermediate node 86b of the pair of intermediate nodes 86 at a second outer frame proximal joint 84.

[0213] Still referring to Figure 2A . Generally, the struts of the outer frame 80 are arranged in a multi-strut form, such as a double-strut form. In the double-strut form:

[0214] · Two pairs of distal struts of the outer frame (i.e., two struts 87 and two struts 89) are arranged side by side with each other. The double-strut structure at the outflow distal end 28 of the outer frame 80 defines the distal perimeter of the outer frame 80 and is arranged in a wavy or zigzag pattern in the form of a series of rising and falling struts between circumferentially adjacent distal nodes 88. According to the inventors' speculation, this double-strut structure provides radial strength and rigidity for the outflow distal end of the outer frame 80 and the artificial valve 22, and

[0215] · Two pairs of proximal struts of the outer frame (i.e., two struts 83 and two struts 85) are arranged side by side with each other. The double-strut structure at the inflow proximal end 26 of the outer frame 80 defines the proximal perimeter of the outer frame 80 and is arranged in a wavy or zigzag pattern in the form of a series of rising and falling struts between circumferentially adjacent proximal joints 84. According to the inventors' speculation, this double-strut structure provides radial strength and rigidity for the inflow proximal part of the outer frame 80 and the artificial valve 22.

[0216] Generally, as Figure 2A shown in -B, the entire outer frame 80 is arranged in a multi-strut form, such as a double-strut form.

[0217] Alternatively, the multi-strut structure is a triple-strut structure, as described below with reference to Figure 9 the following.

[0218] The multi-strut structure (such as a double-strut structure) of the outer frame 80 enhances the strength of the outer frame 80 so that it will not deform when subjected to hydrodynamic forces and other forces exerted by the native tissue on the artificial valve 22.

[0219] Generally, two pairs of proximal struts of the outer frame (i.e., two struts 83 and two struts 85) and the outer frame proximal joints 84 and 94 are provided in the anchoring region 90 of the outer frame 80 and the artificial valve 22 and provide increased radial strength and rigidity for the valve 22 at the anchoring region 90. Generally, the outer frame proximal struts 83 and 85 and the outer frame proximal joints 84 and 94 are covered with foam, such as polyurethane.

[0220] The outer frame proximal joint 84 extends further radially from the axis ax1 than the distal node 88, such that the proximal end 26 of the outer frame 80 is wider than the distal end 28 of the outer frame 80.

[0221] Referring to Figure 2A-B. Each outer frame proximal joint 84 is circumferentially aligned with a corresponding distal node 88. The outer frame proximal joints 84 are longitudinally aligned. As shown, the outer frame 80 includes at least four outer frame proximal joints 84a, 84b, 84c, and 84d. For example, as shown, the outer frame 80 includes at least six outer frame proximal joints 84a, 84b, 84c, 84d, 84e, and 84f. Each outer frame proximal joint 84 (in some embodiments, together with joint 94) defines a tissue position locator 93 that is configured to engage and position tissue with respect to the outflow surface of the native commissure of the native leaflets of the native aortic valve. Each locator 93 is formed by a pair of outer frame struts 82 that converge at respective outer frame joints (i.e., 84 and / or 94) that point in the proximal direction. Multiple pairs of outer frame struts 82 are circumferentially arranged to engage the outflow surface of the native aortic valve. The locators 93 are generally not specifically aligned with the cusps or commissures of the native aortic valve, although they may be accidentally aligned during deployment. Alternatively, the prosthetic valve 22 is rotated during delivery such that exactly two locators 93 are disposed within each native commissure of the native aortic valve.

[0222] As Figure 2A shown in -B, each pair of outer frame struts 82 includes at least two proximal struts 83 that extend proximally from respective circumferentially adjacent intermediate nodes 86. For embodiments in which the outer frame 80 is arranged in a multi-strut configuration (e.g., the double-strut configuration shown), each pair of outer frame struts 82 includes at least (1) two proximal struts 83 that extend proximally from respective circumferentially adjacent intermediate nodes 86, and (2) two proximal struts 85 that extend proximally from respective circumferentially adjacent intermediate nodes 86. As shown, the outer frame 80 includes at least four pairs of outer frame struts 82. For example, as shown, the outer frame 80 includes at least six pairs of outer frame struts 82, as Figure 2A shown in the isometric view and Figure 2B -C; in Figure 2A an enlarged portion of, a circumferential half-side of the outer frame 80 is shown, and three of the six pairs of struts are visible, labeled 82a, 82b, and 82c.

[0223] Thus, the prosthetic valve 22 defines at least four (e.g., as Figure 2A-C, the outer frame tissue anchor 98, each outer frame tissue anchor 98 includes (1) a pair of outer frame struts 82 (in some embodiments, including a pair of double-strut outer frame struts 83 and 85), and (2) an outer frame proximal joint 84 (in some embodiments, including joint 94), which defines a tissue position locator 93. Different from a traditional artificial aortic valve that typically includes three locators and three tissue anchors, the artificial valve 22 of the present invention includes at least four (e.g., six) locators 93 and anchors 98 to increase imaging visibility and improve the likelihood of correct alignment, anchoring, and sealing of the artificial valve 22 with the native aortic valve.

[0224] The pair of outer frame struts 82 and the outer frame proximal joints 84 and 94 that define the locator 93 are disposed in the tissue positioning region 91 of the outer frame 80 and the artificial valve 22, and provide increased radial strength and rigidity to the valve 22 at the tissue positioning region 91.

[0225] Each distal node 88 has at least two struts extending therefrom, which include distal struts 89 extending proximally from the first and second distal nodes. As shown, each distal node 88 has at least four struts extending therefrom, which include distal struts 89 extending proximally from the first and second distal nodes and distal struts 87 extending proximally from the third and fourth distal nodes.

[0226] Figure 3A is an isometric view of the frame assembly 21 as viewed from the inflow-outflow direction. Figure 3B is an isometric view of the frame assembly 21 as viewed from the outflow-inflow direction. Figure 3C -D is a side view of the frame assembly 21 at different rotational angles. Figure 3E is a bottom inflow view of the frame assembly 21. Figure 3F is a top outflow view of the frame assembly 21.

[0227] Figure 3C shows the relative distance between the corresponding joints of the inner frame 24 and the outer frame 80 of the artificial valve 22. As Figure 3CAs shown in the enlarged portion, (1) the intermediate joint 42 of the inner frame 24, (2) the first outer frame proximal joint 94 of the outer frame 80, (3) the second outer frame proximal joint 84 of the outer frame 80 (which defines a part of the tissue position locator 93), (4) the first proximal joint 48a of the inner frame 24, and (5) the second proximal joint 48b of the inner frame 24 all point in the proximal direction and are circumferentially aligned. This relative positioning of the joints of the inner frame 24 and the outer frame 80 reduces the overall gap between the metal parts of the prosthetic valve 22 and increases the overall radial force of the prosthetic valve 22 on the native aortic valve tissue. This specific configuration of multiple circumferentially arranged and longitudinally disposed joints helps the prosthetic valve 22 withstand the high pressure associated with the left ventricular outflow tract and the aortic valve. The prosthetic valve 22 defines a height H4 between (a) the proximal end of the second proximal joint 48b and (b) the proximal end of the first proximal joint 48a, which is between 4.5 - 8.0 mm, for example 5.2 - 6.4 mm. The prosthetic valve 22 defines a height H5 between (a) the proximal end of the first proximal joint 48a and (b) the proximal end of the second outer frame proximal joint 84, which is between 2.2 - 3.0 mm, for example 2.5 - 2.6 mm. The prosthetic valve 22 defines a height H6 between (a) the proximal end of the second outer frame proximal joint 84 and (b) the proximal end of the intermediate joint 42 of the inner frame 24, which is between 1.2 to 2.2 mm, for example, 1.6 to 1.9 mm.

[0228] Thus, the prosthetic valve 22 is configured as follows:

[0229] · The inner frame 24 is shaped to define multiple pairs of inner frame struts that converge at corresponding inner frame joints 42, 48a, and 48b pointing in the proximal direction, and the multiple pairs of inner frame struts are circumferentially arranged to engage the inflow surface of the patient's native aortic valve.

[0230] · The outer frame 80 is shaped to define multiple pairs of outer frame struts 82 that converge at corresponding outer frame joints 84 pointing in the proximal direction, and the multiple pairs of outer frame struts 82 are circumferentially arranged to engage the outflow surface of the native aortic valve.

[0231] · Each outer frame proximal joint 84 is circumferentially aligned with the corresponding inner frame joints 42, 48a, and 48b.

[0232] · The multiple pairs of inner frame struts and the multiple pairs of outer frame struts 82 are configured to engage the leaflets of the native valve between the corresponding pairs of inner frame struts and outer frame struts 82, and

[0233] · The outer frame 80 is shaped to define at least four pairs of outer frame struts 82 and at least four outer frame joints 84.

[0234] Figure 3CAnd the other figures in this document also show the relationship between the intermediate node 86 of the outer frame 80 and the intermediate node 30 of the inner frame 24, particularly the relationship with the reinforcing struts 56 and the proximally directed joint 58. Thus, each pair of reinforcing struts 56a and 56b is combined with the joint 58 and the nodes 30 and 86 to form a corresponding reinforcement region 100 of the prosthetic valve 22. Generally, the reinforcement region 100 reinforces the adjacent artificial commissures of the prosthetic valve 22 that are coupled to the frame assembly 21 of the prosthetic valve 22.

[0235] Figure 3C The leaflet connector 102 is also shown in dashed lines and is typically directly coupled to the inner frame 24, for example, by suturing. The leaflet connector 102 is typically sutured (i.e., stitched) to (1) the corresponding portions of the pair of struts 66 extending proximally from the distal node and / or the corresponding portions of the pair of struts 62 extending proximally from the distal node, and (2) the corresponding portions of the pair of struts 44 extending distally. In some embodiments, the leaflet connector 102 is sutured (i.e., stitched) to the vertical strut 60. It should be noted that the scope of the present invention includes technical solutions in which the leaflet connector 102 is fixed to both the outer frame 80 and the inner frame 24 simultaneously.

[0236] Figure 3D The prosthetic valve 22 is shown, and the outer diameter D1 at the inflow proximal end 26 is 26 - 36 mm, for example, 28.6 - 35.2 mm. The outer diameter D2 at the outflow distal end 28 of the prosthetic valve 22 is 23 - 32 mm, for example, 24.82 - 30.82 mm. The prosthetic valve 22 defines a distance Di1 between the proximal joints 84 of the outer frame tissue anchors 98 adjacent in the circumferential direction as 12 - 19 mm, for example, 14.3 - 17.3 mm. The prosthetic valve 22 defines a distance Di2 between the intermediate nodes 30 of the inner frame 24 adjacent in the circumferential direction as 11 - 18 mm, for example, 13.0 - 15.9 mm. The distance Di2 is also the distance between the circumferentially adjacent intermediate nodes 86 of the outer frame 80.

[0237] The outer frame 80 is directly coupled to the inner frame 24 at the outflow distal end 28. Specifically, the distal node 88 of the outer frame 80 is directly coupled to the distal node 32 of the inner frame 24. Generally, the outer frame 80 is sutured (i.e., stitched) to the inner frame 24. In some embodiments, the outer frame 80 is mechanically coupled to the inner frame 24 in any suitable manner, such as by welding or by a coupling pin or other device. As Figure 3D shown, the outer frame 80 is coupled to the inner frame 24 at the outflow distal end 28 so as to enable the outer frame 80 to have enhanced radial flexibility when traveling from the distal end 28 to the proximal end. In addition, the coupling of the outer frame 80 to the inner frame 24 at the outflow distal end 28 can also increase the radial expansion of the outer frame tissue anchors 98 and the positioning members 93, as described below with reference to Figure 7CAs shown. The struts of the outer frame 80 are not directly connected to the inner frame 24 at the anchoring region 90 and the tissue positioning region 91, such that these struts are capable of (1) bending radially outward to fully accommodate the leaflet tissue while (2) maintaining sufficient rigidity to compress the native leaflets between (1) the outer frame struts 83 and 85 at the anchoring region 90 of the outer frame 80 and (2) the inner frame struts at the anchoring region 90. In some embodiments, the outer frame 80 is directly coupled to the inner frame 24 only at the distal end 28 of the prosthetic valve 22. Thus, as Figure 3D shown, the prosthetic valve 22 defines a distance Di3, between 0.8 - 2.2 millimeters, for example, 1.1 - 1.5 millimeters, between (1) the outer frame proximal joint 84 and the tissue position locator 93 and (2) between the outer surface of the inner frame 24.

[0238] As Figure 3D shown, the annular plane AP is drawn in dashed lines to illustrate the relative position of the prosthetic valve 22 within the native aorta. The anchoring region 90, the tissue positioning region 91, and the supra - annular portion 92 are generally located distal to the annular plane AP, while the sub - annular portion 70 is generally located proximal to the annular plane AP.

[0239] Figure 3E -F show views of the prosthetic valve 22 from the blood inflow and blood outflow directions, respectively. As shown, the prosthetic valve 22 includes three prosthetic leaflets 140 that are arranged to facilitate unidirectional fluid flow through the lumen of the prosthetic valve 22 from inflow to outflow in the proximal - to - distal direction. Figure 3E The covering of the prosthetic valve 22 is not shown in -F. For example, the prosthetic leaflets 140 may include pericardium, such as bovine pericardium or porcine pericardium, or synthetic polymers known in the art of prosthetic valves.

[0240] Now referring to Figure 4A -B, which is a schematic illustration of certain embodiments in accordance with the present invention, showing the inner frame 24 of the prosthetic valve 22 in a crimped configuration for delivery through a delivery tube. In the crimped configuration, the inner frame 24 has an outer diameter D3 after crimping, between 4.5 - 6.5 millimeters, for example 5.5 - 6.0 millimeters.

[0241] Now referring to Figure 5A -B, which is a schematic illustration of certain embodiments in accordance with the present invention, showing the outer frame 80 of the prosthetic valve 22 in a crimped configuration for delivery through a delivery tube. In the crimped configuration, the outer frame 80 has an outer diameter D4 after crimping, which is 5.0 - 7.5 millimeters.

[0242] Now referring to Figure 6A-B, which is a schematic diagram according to certain embodiments of the present invention, showing an artificial valve frame assembly 21, which includes an inner frame 24 and an outer frame 80 of an artificial valve 22, which are in a crimped configuration for delivery through a delivery tube. The outer frame 80 surrounds the inner frame 24.

[0243] In certain embodiments, one or more sacs (not shown) surround all or part of the outer frame 80. In addition, one or more sacs (not shown) surround all or at least the proximal portion of the inner frame 24 to effect controlled release of the artificial valve 22 in the native aortic valve. Each sac can independently control the sequential expansion of the various parts of the valve frame assembly 21 to achieve optimal controlled sequential delivery of the artificial valve 22.

[0244] Now refer to Figure 7A -F, which is a schematic diagram according to certain embodiments of the present invention, showing a method of transcatheter implantation of an artificial valve 22 at a patient's native aortic valve 120. The figure also shows a system 20, which includes an artificial valve 22 and a delivery system 131. The delivery system 131 includes a delivery tube 132 that houses the artificial valve 22 in a crimped (compressed) configuration. The system advances the artificial valve 22 into the aortic valve 120 via a transaortic approach, as shown. Note that the tube 132 can be inserted through a blood vessel in the leg (transfemoral), a major blood vessel of the heart (transaortic), or the apex of the heart (transapical).

[0245] In Figure 7A when the distal end of the tube 132 is positioned within the aorta 121 downstream of the aortic valve 120, the upstream proximal end 26 of the artificial valve 22 is exposed from within the tube 132. Thus, the proximal end 26 is exposed upstream of the aortic sinus of the ascending aorta, upstream of the openings 124 and 126 of the coronary arteries 123 and 125, and upstream of the downstream surface of the native leaflets 122 of the native aortic valve 120.

[0246] In Figure 7B the artificial valve 22 is advanced proximally out of the tube 132 and moved axially both proximally and distally to correctly position the artificial valve 22 within the native aortic valve 120. Note that one or more delivery sacs (not shown) surround the artificial valve 22 to keep it in a crimped configuration. As shown, the artificial valve 22 is reversibly coupled to the delivery tube 132 by appendages 81.

[0247] In Figure 7CIn this case, the proximal portion of the outer frame 80 of the prosthetic valve 22 is exposed from within one or more delivery sheaths (not shown), causing the outer frame tissue anchors 98 to expand radially. These outer frame tissue anchors together form a downstream flange. Under image guidance, the prosthetic valve 22 is moved such that the outer frame tissue anchors 98 and the tissue positioners 93 are positioned on the downstream surface of the commissures of the native leaflets 122 of the native aortic valve 120. In this way, the prosthetic valve 22 is delivered to the native aortic valve 120 such that the native leaflets 122 are located between the outer frame tissue anchors 98 and the outer surface of the inner frame 24. Accordingly, the positioning region 91 of the outer frame 80 is properly positioned on the downstream surface of the native aortic valve 120. At this stage, the outer frame tissue anchors 98 and the positioners 93 are expanding and being positioned, while the inner frame 24 remains within one or more sheaths (not shown) such that the inner frame 24 remains in a crimped configuration. Additionally, at this stage, since the appendage 81 is surrounded by the end of the delivery tube 132, the distal end 28 remains in a crimped state.

[0248] Typically, the outer frame tissue anchors 98 and the positioners 93 expand radially from within the delivery sheath by retracting the delivery sheath distally. In some embodiments, the outer frame tissue anchors 98 and the positioners 93 are allowed to expand radially at a position downstream of the native aortic valve 120. In such embodiments, the prosthetic valve 22 is then pushed in the upstream direction in order to position the outer frame tissue anchors 98 and the positioners 93 on the downstream surface of the native aortic valve 120, as described below with reference to Figure 7D that which is described. In some embodiments, the delivery tube 132 is advanced upstream such that its distal end is located within the left ventricle, and the outer frame tissue anchors 98 and the positioners 93 are allowed to expand radially at a position upstream of the native aortic valve 120 (e.g., within the left ventricle). In such embodiments, then (1) the prosthetic valve 22 is retracted in the downstream direction in order to pull the outer frame tissue anchors 98 and the positioners 93 through the native aortic valve 120 downstream, and subsequently, (2) the prosthetic valve 22 is pushed in the upstream direction in order to position the outer frame tissue anchors 98 and the positioners 93 on the downstream surface of the native aortic valve 120, as described below with reference to Figure 7D that which is described.

[0249] In Figure 7DIn this case, the prosthetic valve 22 is pushed by the delivery tube 132 in the upstream and proximal directions relative to the native aortic valve, such that the outer frame tissue anchor 98 and the tissue positioner 93 are properly positioned on the downstream surface of the commissure of the native leaflets 122 of the native aortic valve 120. Additionally, the positioner 93 and the proximal connector 84 are pushed in the proximal (upstream) direction until they abut and align with the downstream surface of the commissure 127 of the native aortic valve 120. That is, the connector 84 contacts the base of the leaflet 122 at the junction between the atrial wall and the leaflet 122. In some embodiments, the connector 84 contacts the base of the leaflet 122 at the middle of the commissure 127. Under image guidance, such as fluoroscopy, the proper alignment and position of the connector 84 at the commissure 127 are confirmed by the positioner 93, which generally but not necessarily includes radiopaque markers. In some embodiments, the first portion of the positioner 93 and / or the first outer frame proximal connector 94 includes radiopaque markers, while the second portion of the positioner 93 and / or the first outer frame proximal connector 94 does not include radiopaque markers and thus functions as a tissue anchor. The first portion of the positioner 93 and / or the first portion of the first outer frame proximal connector 94 is the positioner 93 and / or the first outer frame proximal connector 94 at the connector of the prosthetic valve 22. The first portion of the positioner 93 and / or the first portion of the first outer frame proximal connector 94 includes radiopaque markers, which assist in aligning the commissure of the prosthetic valve 22 with the native commissure of the native aortic valve 120. In addition to assisting in the positioning of the prosthetic valve 22 by facilitating imaging, the first portion of the positioner 93 and / or the first portion of the first outer frame proximal connector 94 also provides tactile feedback during valve positioning. The second portion of the positioner 93 and / or the first outer frame proximal connector 94 is used to provide tactile feedback during positioning and to provide an anchoring function.

[0250] The outer frame tissue anchor 98 and the positioner 93 provide mechanical anchoring to prevent the prosthetic valve 22 from moving away from the native aortic valve 120 in the upstream direction and towards the left ventricle.

[0251] At this stage, (1) it is confirmed that the tissue anchor 98 is properly positioned on the downstream surface of the native leaflet 122, and (2) the positioner 93 is properly aligned with the cusp 127. The inner frame 24 remains within one or more capsules (not shown) such that the inner frame 24 remains in a crimped configuration. Additionally, at this stage, since the appendage 81 is surrounded by the end of the delivery tube 132, the distal end 28 remains in a crimped state.

[0252] In Figure 7EIn [description], the proximal portion of the inner frame 24 expands. The proximal portion of the inner frame 24 defines an upstream flange. To expand the inner frame 24, the capsule surrounding the inner frame 24 is typically pushed in the proximal direction from around the inner frame 24, retracted distally through the prosthetic valve 22, and finally exits the patient's body through the aorta 121. At this stage, the proximal portion of the inner frame 24 exerts a radial force on the native tissue of the native aortic valve 120, thereby preventing and eliminating displacement of the prosthetic valve 22 in the upstream and downstream directions. Additionally, at this stage, the native leaflets 122 are sandwiched between (1) the tissue anchor 98 of the prosthetic valve 22 and (2) the proximal portion of the inner frame 24 at the anchoring region 90.

[0253] Figure 7F Shows the prosthetic valve 22 fully implanted in the native aortic valve 120. By fully retracting the delivery tube 132 (not shown), the tube 132 is positioned distal and downstream of the appendage 81, thereby allowing the distal end 28 of the prosthetic valve 22 to expand. Once the tube 132 is not surrounding the appendage 81, the distal end 28 of the valve 22 can expand. Figure 7F Shows the proper alignment and sealing of the prosthetic valve 22 with the native aortic valve 120. As shown, due to the total height H1 of the prosthetic valve 22, the distal end 28 of the prosthetic valve 22 does not extend downstream to the aortic sinuses or the openings 124 and 126 of the coronary arteries 123 and 125. Thus, due to the total height of the prosthetic valve 22, the prosthetic valve 22 does not block any of the openings 124 or 126 of the coronary arteries 123 and 125. As described above, the height H1 of the prosthetic valve 22 is 20 - 26 mm, for example 22.0 - 24.83 mm. H1 generally does not include the appendage 81.

[0254] The prosthetic valve 22 is covered by a covering 130 that includes one or more sheets, such as fabric, polyester (such as Dacron(TM)), or any other suitable material. It should be noted that for ease of illustration, only a partial coverage of the prosthetic valve 22 by the covering 130 is shown in the figure.

[0255] The supra - annular portion 92 is located downstream of the annular plane AP, while the sub - annular portion 70 is located upstream of the annular plane AP. Generally, as described above, the sub - annular portion 70 is covered by a covering 150, such as fabric, polyester (e.g., Dacron(TM)), velvet cloth, an inflatable cuff that can be inflated with blood or fluid, and / or any other suitable material. By exerting a radial force on the native tissue, the sub - annular portion 70 helps to ensure sufficient fixation and sealing of the prosthetic valve 22 to the native aortic valve 120 and prevent and eliminate paravalvular leakage.

[0256] The anchoring region 90 provides mechanical anchoring and prevents the prosthetic valve 22 from migrating upstream into the left ventricle, while the subannular portion 70 applies sufficient radial force to the tissue of the aortic valve 120 to ensure that the prosthetic valve 22 remains firmly implanted and does not migrate in the upstream or downstream directions. The overall construction of the frame assembly 21 of the prosthetic valve 22 ensures that the prosthetic valve 22 can withstand and endure the high-pressure environment of the native aortic valve 120.

[0257] As shown, the metal struts of the prosthetic valve 22 at the anchoring region 90 are robust and durable, thereby providing reinforcement for the prosthetic valve 22. Specifically, (1) the reinforcing struts 56a and 56b at the reinforcement region 100 of the prosthetic valve 22 define a semi-double strut region of the prosthetic valve 22, (2) the intermediate strut 40, (3) the intermediate node 30, (4) the joint 58, (5) the intermediate joint 42, and (6) the joints 84 and 94 of the outer frame 80 provide enhanced structural support for the anchoring region 90.

[0258] In addition, the semi-double strut region of the inner frame 24 enhances the strength of the inner frame 24 such that it does not deform due to hydrodynamic and other forces exerted by the native tissue on the prosthetic valve 22.

[0259] Furthermore, the prosthetic valve 22 is robust and durable in the metal struts at the subannular portion 70, thereby providing reinforcement for the prosthetic valve 22. Specifically, (1) the strut 52, (2) the joint 54, (3) the joints 48a, and (6) the joint 48b provide enhanced structural support for the subannular portion 70.

[0260] Overall, the partial double strut construction of the inner frame 24 and the entire outer frame 80 provides enhanced structural support for the prosthetic valve 22.

[0261] Reference is now made to Figure 8 , which is a schematic view of an inner frame 224 according to an embodiment of the present invention. For clarity, Figure 8 a circumferential half side of the inner frame 224 is shown. The inner frame 224 can be assembled with any of the outer frames described herein to form a prosthetic valve frame assembly. By way of example and not limitation, in Figure 10 described below, the inner frame 224 is shown assembled with an outer frame 280 to form a prosthetic valve frame assembly 221. Except as otherwise described below, the inner frame 224 can be the same as the inner frame 24 referenced above Figure 1A - 7F and can implement any of its features with necessary modifications in detail; like reference numerals denote like components.

[0262] The inner frame 224 is shaped to define a plurality of intermediate nodes 230 that are located between the proximal end 26 and the distal end 28 of the inner frame 224. In Figure 8 (and as described below in Figure 10 ),11A In the configuration shown in -C and 12), each intermediate node 230 has at least eight struts extending therefrom, for example, as shown, exactly eight struts.

[0263] The struts extending from each intermediate node 230 include:

[0264] · As referred to above Figure 1A -D, two struts 44 extending distally of a pair of at least eight struts described above, in Figure 8 the configuration, which are the first pair of two struts 44 extending distally,

[0265] · A second pair of two struts 247 extending distally of at least eight struts,

[0266] · A first pair of two struts 46 extending proximally of at least eight struts, as referred to above Figure 1A -D, and

[0267] · A second pair of two struts 50 extending proximally of at least eight struts, as referred to above Figure 1A -D.

[0268] For each pair of circumferentially adjacent intermediate nodes 230, for example:

[0269] · (i) A first distally extending strut 44a extending from one intermediate node 230a of the pair of intermediate nodes 230 converges at a distal joint 45 with (ii) a second distally extending strut 44b extending from the other intermediate node 230b of the pair of intermediate nodes 230,

[0270] · (i) A third distally extending strut 247a extending from one intermediate node 230a of the pair of intermediate nodes 230 converges at a distal joint 45 with (ii) a fourth distally extending strut 247b extending from the other intermediate node 230b of the pair of intermediate nodes 230; the third distally extending strut 247a is distal to the first distally extending strut 44a; the fourth distally extending strut 247b is distal to the second distally extending strut 44b,

[0271] · (i) A first proximally extending strut 46a extending from one intermediate node 230a of the pair of intermediate nodes 230 converges at a proximal joint 48a with (ii) a second proximally extending strut 46b extending from the other intermediate node 230b of the pair of intermediate nodes 230, and

[0272] · (i) A third proximally extending strut 50a extending from one of the pair of intermediate nodes 230, i.e., 230a, converges with (ii) a fourth proximally extending strut 50b extending from the other of the pair of intermediate nodes 230, i.e., 230b, at a second proximal joint 48b; the third proximally extending strut 50a is close to the first proximally extending strut 46a; the fourth proximally extending strut 50b is close to the second proximally extending strut 46b; the second proximal joint 48b is close to the first proximal joint 48a; and the first and second proximal joints 48a and 48b are circumferentially aligned.

[0273] In some embodiments, (i) a first intermediate strut 40a extends proximally from an intermediate position 39a of a first distally extending strut 44a, and (ii) a second intermediate strut 40b extends proximally from an intermediate position 39b of a second distally extending strut 44b; the intermediate position 39a of the first distally extending strut 44a is located between an intermediate node 230a and a distal joint 45; the intermediate position 39b of the second distally extending strut 44b is located between another intermediate node 230b and the distal joint 45. In some of these embodiments, the first intermediate strut 40a and the second intermediate strut 40b have some or all of the features described above with reference to Figure 1A -D.

[0274] The first pair of two distally extending struts 44 and the second pair of two distally extending struts 247 can be described as arranged in a double-strut form, where the first pair and the second pair are arranged side by side with each other. This double-strut form of struts is arranged in a wavy or zigzag pattern between circumferentially adjacent distal joints 45. According to the inventors' speculation, the double-strut structure can provide radial strength and rigidity to the prosthetic valve 22. In addition, this double-strut structure of the inner frame 224 enhances the strength of the inner frame 224 so that it will not deform due to hydrodynamic and other forces exerted by the native tissue on the prosthetic valve 22.

[0275] In some embodiments, successive segments of the first and second intermediate struts 40a and 40b respectively extend from the corresponding upstream sides of the first and second distally extending struts 44a and 44b and bend at the curvature angles and directions described above with reference to Figure 1A -B. In addition to providing one or both of the advantages described above with reference to Figure 1A -B, this shape of the first and second intermediate struts 40a and 40b also helps to maintain an appropriate distance between the double struts (i.e., the first intermediate strut 40 and the second pair of two distally extending struts 247).

[0276] As described above with reference to Figure 1A-D, 2A-C, and 3A-F describe the inner frame 24. The struts of the distal outflow portion of the inner frame 224 can be described as being arranged in a double-strut form, where two pairs of distal struts of the inner frame (two struts 62 extending proximally from one pair of distal nodes and two struts 66 extending proximally from a second pair of distal nodes) are arranged side by side with each other. Similarly, as referred to above Figure 1A -D, 2A-C, and 3A-F describe the inner frame 24:

[0277] · A first distal node-proximal extending strut 62a extending from one distal node 32a of a pair of distal nodes 32 converges at a first outflow joint 64a with (ii) a second distal node-proximal extending strut 62b extending from the other distal node 32b of the pair of distal nodes 32,

[0278] · A third distal node-proximal extending strut 66a extending from one distal node 32a of the pair of distal nodes 32 converges at a second outflow joint 64b with (ii) a third distal node-proximal extending strut 66b extending from the other distal node 32b of the pair of distal nodes, and

[0279] · The first and second outflow joints 64a and 64b are circumferentially aligned.

[0280] In Figure 8 the configuration of the inner frame 224 shown, the first and second outflow joints 64a and 64b are connected at an outflow node 264. Optionally, the inner frame 24 described above with reference to Figure 1A -D, 2A-C, and 3A-F can achieve this feature.

[0281] As described above with respect to the inner frame 24, the inner frame 224 is also shaped to define a plurality of distal nodes 32 at the distal end 28 of the inner frame 224. In some embodiments, each distal node 32 is shaped to define two notches 229 to facilitate suturing the inner frame 224 to the outer frame 280.

[0282] Now refer to Figure 9 , which is a schematic view of an outer frame 280 according to an embodiment of the present invention. For clarity, Figure 9 a circumferential half-side of the outer frame 280 is shown. The outer frame 280 can be assembled with any of the inner frames described herein to form an artificial valve frame assembly. By way of example and not limitation, in Figure 10 described below, the outer frame 280 is shown assembled with the inner frame 224 to form an artificial valve frame assembly 221. Except as described below, the outer frame 280 can be the same as the outer frame 80 referred to above with reference to Figure 1A - 7F and can implement any of its features with necessary modifications in details; the same reference numerals represent the same components.

[0283] The outer frame 280 is shaped to define a plurality of intermediate nodes 286 that are located between the proximal end 26 and the distal end 28 of the outer frame 280. In Figure 9 (and the configuration shown in Figure 10 described below), each intermediate node 286 has at least 12 struts extending therefrom, for example, as shown in the figure, exactly 12 struts.

[0284] The struts extending from each intermediate node include:

[0285] · A first pair of two struts 87 (87a and 87b) that extend distally among the at least 12 struts, as described above with reference to Figure 2A -C,

[0286] · A second pair of two struts 89 that extend distally among the at least 12 struts, as described above with reference to Figure 2A -C,

[0287] · A third pair of two struts 295 that extend distally among the at least 12 struts,

[0288] · A first pair of two struts 85 that extend proximally among the at least 12 struts, as described above with reference to Figure 2A -C,

[0289] · A second pair of two struts 83 that extend proximally among the at least 12 struts, as described above with reference to Figure 2A -C, and

[0290] · A third pair of two struts 297 that extend proximally among the at least 12 struts.

[0291] For each pair of circumferentially adjacent intermediate nodes 286, for example:

[0292] · (i) A first distally extending distal strut 87a extending from one intermediate node 286a of a pair of intermediate nodes 286 converges with (ii) a second distally extending distal strut 87b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at a distal node 88,

[0293] · (i) A third distally extending distal strut 89a extending from one intermediate node 286a of the pair of intermediate nodes 286 converges with (ii) a fourth distally extending distal strut 89b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at a distal node 88,

[0294] ·(i) The fifth distally extending strut 295a extending from one of the pair of intermediate nodes 286, i.e., 286a, converges with (ii) the sixth distally extending strut 295b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at the distal intermediate node 296.

[0295] ·(i) The first proximally extending proximal strut 85a extending from one of the pair of intermediate nodes 286, i.e., 286a, converges with (ii) the second proximally extending proximal strut 85b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at the first outer frame proximal joint 94.

[0296] ·(i) The third proximally extending proximal strut 83a extending from one of the pair of intermediate nodes 286, i.e., 286a, converges with (ii) the fourth proximally extending proximal strut 83b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at the second outer frame proximal joint 84, and

[0297] ·(i) The fifth proximally extending strut 297a extending from one of the pair of intermediate nodes 286, i.e., 286a, converges with (ii) the sixth proximally extending strut 297b extending from the other intermediate node 286b of the pair of intermediate nodes 286 at the proximal intermediate node 299. Optionally, the distal intermediate node 296 and the proximal intermediate node 299 are circumferentially aligned as shown.

[0298] The first pair of two distally extending struts 87, the second pair of two distally extending struts 89, and the third pair of two distally extending struts 295 can be described as arranged in a multi-strut form, such as a three-strut form, where the first pair, the second pair, and the third pair are arranged side by side with each other. Optionally, (i) the average distance between the second pair of two distally extending struts 89 and the third pair of two distally extending struts 295 is greater than (ii) the average distance between the first pair of two distally extending struts 87 and the second pair of two distally extending struts 89, as Figure 9 and 10 shown.

[0299] Optionally, the intermediate node 286 is shaped to define a corresponding narrow waist, which can be used as a suture point between the inner frame and the outer frame, as shown for example.

[0300] As described above with respect to the outer frame 80, the outer frame 280 can also be shaped to define a plurality of distal nodes 88 at the distal end 28 of the outer frame 280. In some embodiments, each distal node 88 is shaped to define two notches 233 to facilitate suturing the outer frame 280 to the inner frame 224.

[0301] Now referring to Figure 10, which shows a schematic diagram of an artificial valve 222 according to certain embodiments of the present invention. The artificial valve 222 includes an artificial valve frame assembly 221, which includes an inner frame 224 and an outer frame 280. For clarity, Figure 10 a circumferential half of the artificial valve 222 is shown. Also for illustration clarity, Figure 10 the artificial leaflets 140 are omitted, although the artificial valve 222 may include artificial leaflets 140. Optionally, the artificial valve 222 further includes a skirt 300, as described below with reference to Figure 11A -C.

[0302] Now refer to Figure 11A -B, which is a schematic diagram of the inner frame 224 of the artificial valve 222 according to various embodiments of the present invention, including a skirt 300 and artificial leaflets 140.

[0303] Also refer to Figure 11C , which is a schematic diagram of the artificial valve frame assembly 221 of the artificial valve 222 according to an embodiment of the present invention, including a skirt 300 and artificial leaflets 140.

[0304] Figure 11A The features of -B and / or 11C can be incorporated into any other artificial valve described herein.

[0305] In Figure 11A -C, the artificial leaflets 140 are partially visible and partially covered by the skirt 300. In Figure 3E -F, the artificial leaflets 140 may be better seen, where the frame assembly 21 of the artificial valve 22 is shown. As described below, in Figure 11A -C, the sutures connecting the artificial leaflets 140 to the skirt 300 can be seen.

[0306] In certain embodiments, the artificial valve 222 includes a skirt 300 that covers a portion of the inner frame 224 of the artificial valve 222, as shown. The skirt 300 can help prevent paravalvular leakage (PVL). The skirt 300 can be attached to the inner surface of the inner frame 224 (as shown) and / or the outer surface of the inner frame (this configuration is not shown). Alternatively, the skirt 300 can cover a portion of the outer frame 280 (this configuration is not shown). For example, the skirt 300 can include polyethylene terephthalate (PET), polyurethane (PU), or pericardium, such as bovine pericardium or porcine pericardium.

[0307] In a configuration where the skirt 300 covers a portion of the artificial valve 222 at the height of the artificial leaflets 140 (as shown), the skirt 300 can be shaped to define an opening 304, which can provide coronary artery access, for example, for future percutaneous coronary intervention (PCI).

[0308] In some embodiments, the artificial leaflet 140 is coupled to the skirt 300, for example by suture 302, which may be made of polyester, such as braided polyester.

[0309] In some embodiments, in addition to or instead of the skirt 300, the artificial valve 222 further includes an upstream cuff 310, as Figure 11B shown. The upstream cuff 310 may help prevent paravalvular leakage (PVL). The upstream cuff 310 may be selectively folded over the upstream proximal end 26 of the artificial valve 222, as shown. The upstream cuff 310 may be coupled to the upstream end of the skirt 300 portion, for example by suturing or the like, or may be integrally formed with the skirt 300, i.e., made of the same material as the skirt. The upstream cuff 310 may be attached to the inner frame 224 (as shown) and / or the outer frame 280 (this configuration is not shown). For example, the upstream cuff 310 may be made of polyethylene terephthalate (PET), polyurethane (PU), or pericardium, such as bovine pericardium or porcine pericardium. Alternatively, the artificial valve 222 does not include the upstream cuff 310, as Figure 11A and 11C shown.

[0310] Now refer to Figure 12A -H, which is a schematic diagram of an additional configuration of the inner frame 224 according to various embodiments of the present invention. For clarity of illustration, Figure 12A -H shows the circumferential half side of the inner frame 224. These configurations may be implemented in combination with any configuration of the inner frame described herein, or instead of any configuration of the inner frame described herein.

[0311] Figure 12A The configuration of the inner frame 224 shown is the same as the configuration of the inner frame 224 shown in Figure 8 except that the first and second outflow joints 64a and 64b are not connected at the outflow node 264. In this regard, Figure 12A the configuration of the inner frame 224 shown is similar to the configuration of the inner frame 24 shown in Figure 1A -C.

[0312] In Figure 12B the configuration of the inner frame 224 shown, the inner frame 224 is shaped to define:

[0313] · Reinforcing struts 56, as described above with reference to Figure 1A -C,

[0314] · A first pair of two struts 344 extending distally in opposite directions, similar to the first pair of two struts 44 extending distally in opposite directions described above with reference to Figure 1A -C, and

[0315] · A second pair of two struts 347 extending distally in opposite directions, similar to the second pair of two struts described above with reference to Figure 10The two struts 247 that extend distally in opposite directions as described above.

[0316] Generally speaking, these struts can be described as being partially arranged in a three-strut form and partially in a two-strut form.

[0317] Figure 12C -H shows other alternative configurations of the inner frame 224.

[0318] Now refer to Figure 13A -C, which is a schematic view of an additional configuration of the outer frame 80 according to various embodiments of the present invention. For clarity, Figure 13A -C shows the circumferential half-side of the outer frame 80.

[0319] Figure 13B The configuration of the outer frame 80 shown in -C is generally similar to the configuration shown in Figure 2A , except that the shape of each distal node 88 defines two notches 233 to facilitate suturing the outer frame to the inner frame, as described above with reference to Figure 9 the outer frame 280. Figure 13B The strut shapes in the configuration shown in are slightly different from those shown in Fig. 13C. Any of these shapes can be implemented in any outer frame configuration described herein and can be modified as necessary in detail.

[0320] Now refer to Figure 14 , which is a schematic view of the outer frame 380 according to an embodiment of the present invention. For clarity, Figure 14 the circumferential half-side of the outer frame 380 is shown. The features of this configuration can be combined with or implemented in place of any other outer frame described herein. Except as described below, this configuration is generally similar to the configuration of the outer frame 80 described above with reference to Figure 2A -C.

[0321] In the outer frame 380, each intermediate node 86 has at least eight struts extending therefrom, as shown, and the struts extending from each intermediate node 86 include (a) two struts 387 (387a and 387b) that extend distally in opposite directions among the at least eight struts, (b) two struts 89 that extend distally in opposite directions among the at least eight struts, (c) two struts 385 that extend proximally in opposite directions among the at least eight struts, and (d) two struts 83 that extend proximally in opposite directions among the at least eight struts. These four pairs of struts together define a bracket unit 390.

[0322] The first pair of proximally extending struts 385 includes (i) a first proximally extending proximal strut 385a that extends from one of the pair of intermediate nodes 86, i.e., intermediate node 86a, and converges at the first outer frame proximal joint 94 with (ii) a second proximally extending proximal strut 385b that extends from the other intermediate node 86b of the pair of intermediate nodes 86.

[0323] The first pair of distally extending struts 387 includes: (i) a first distally extending distal strut 387a that extends from one of the pair of intermediate nodes 86, i.e., intermediate node 86a, and converges at the distal node 88 with (ii) a second distally extending distal strut 387b that extends from the other intermediate node 86b of the pair of intermediate nodes 86.

[0324] For each stent unit 390 defined as above, the outer frame 380 is further shaped to define the following four struts arranged in a substantially X-shape within the stent unit 390:

[0325] · A first and a second distal strut 392a and 392b extend respectively from the first distally extending distal strut 387a and the second distally extending distal strut 387b and converge at the central joint 396, and

[0326] · A first and a second proximal strut 394a and 394b extend respectively from the first proximally extending proximal strut 385a and the second proximally extending proximal

[0327] strut 385b and converge at the central joint 396.

[0328] Reference is now made to Figure 1A - 7F . It should be noted that although the described artificial valve is described as being configured to be implanted in a patient's native aortic valve, the artificial valve can also be configured to be implanted in other heart valves of a patient, such as the pulmonary valve, mitral valve, and tricuspid valve.

[0329] Those skilled in the art will recognize that the present invention is not limited to what is specifically shown and described above. Instead, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications that are not found in the prior art that occur to those skilled in the art upon reading the above description.

Claims

1. An artificial valve configured for transcatheter implantation, the artificial valve comprising: An artificial valve framework that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in an expanded state; and A plurality of artificial valve leaflets located within the lumen and arranged to facilitate unidirectional fluid flow from inflow to outflow through the lumen in a proximal-to-distal direction when the artificial valve is in an expanded state, wherein the artificial valve framework: comprises a plurality of struts, and is shaped to define a plurality of intermediate nodes located between a proximal end and a distal end of the artificial valve framework, wherein a portion of the plurality of struts are intermediate struts, wherein each intermediate node has at least four struts extending therefrom, the at least four struts including (a) a pair of two struts extending distally among the at least four struts, and (b) a pair of two struts extending proximally among the at least four struts, wherein, for each circumferentially adjacent pair of intermediate nodes: (i) a first distally extending strut extending from one intermediate node of the pair of intermediate nodes converges with (ii) a second distally extending strut extending from the other intermediate node of the pair of intermediate nodes at a distal joint, (i) a first proximally extending strut extending from one intermediate node of the pair of intermediate nodes converges with (ii) a second proximally extending strut extending from the other intermediate node of the pair of intermediate nodes at a proximal joint, and (i) a first intermediate strut extends proximally from an intermediate position of the first distally extending strut, and (ii) a second intermediate strut extends proximally from an intermediate position of the second distally extending strut, the intermediate position of the first distally extending strut being between an intermediate node and the distal joint, and the intermediate position of the second distally extending strut being between another intermediate node and the distal joint, wherein the first and second intermediate struts converge at an intermediate joint in a proximal direction, wherein the intermediate joint is located between the distal joint and the proximal joint, and wherein the intermediate joint, the distal joint, and the proximal joint are circumferentially aligned.

2. The artificial valve according to claim 1, wherein when the artificial valve is in the expanded state, for each pair of circumferentially adjacent intermediate nodes: the smaller rhombus of the artificial valve frame is defined by (1) the distal portions of the first and second distally extending struts and (2) the first and second intermediate struts, and the larger rhombus of the artificial valve frame is defined by (1) the first and second distally extending struts and (2) the first and second proximally extending struts, wherein, The smaller rhombus is located within the larger rhombus.

3. The artificial valve according to claim 1, wherein the first and second intermediate struts have respective continuous longitudinal sections, wherein, When the artificial valve is in an expanded state, the respective continuous longitudinal segments: extend from upstream sides of the first and second distally extending struts at an angle of 75 - 105 degrees, bend upstream along respective first curved longitudinal segment portions of the first and second intermediate struts and bend towards their respective nearest intermediate nodes, and bend upstream along respective second curved longitudinal segment portions of the first and second intermediate struts and bend away from their respective nearest intermediate nodes.

4. The artificial valve according to claim 3, wherein, The length of each of the first curved longitudinal segments is 0.2 - 0.75 millimeters, and the length of each of the second curved longitudinal segments is 1 - 1.75 millimeters, the length being measured along the respective curved central longitudinal axis of the curved longitudinal segment.

5. The artificial valve according to claim 3, wherein, Each of the first curved longitudinal segments has a first length, and each of the second curved longitudinal segments has a second length, the length being measured along the respective curved central longitudinal axis of the curved longitudinal segment, and wherein the ratio of the second length to the first length is 2 - 8.

6. The artificial valve according to claim 3, wherein, Each of the first curved longitudinal segments has a first inner curvature radius of 0.05 - 0.2 mm, and each of the second curved longitudinal segments has a second inner curvature radius of 0.4 - 0.8 mm.

7. The artificial valve according to claim 3, wherein,Each of the first curved longitudinal segments has a first inner curvature radius, and each of the second curved longitudinal segments has a second inner curvature radius, and wherein the ratio of the second inner curvature radius to the first inner curvature radius is 2 - 10.

8. The artificial valve according to claim 1, wherein, The overall height of the artificial valve frame in the expanded state is 20 - 26 mm.

9. The artificial valve according to any one of claims 1-8, wherein each intermediate node has at least six struts extending therefrom, wherein, The two struts extending proximally in opposite directions define the first two struts among the at least six struts that extend proximally in opposite directions, wherein the at least six struts include the second two struts among the at least six struts that extend proximally in opposite directions, wherein the proximal joint defines a first proximal joint, and wherein, for each pair of circumferentially adjacent intermediate nodes: (i) The third strut extending proximally from one of the intermediate nodes in the pair converges at the second proximal joint with (ii) the fourth strut extending proximally from the other intermediate node in the pair, The third strut extending proximally is located proximal to the first strut extending proximally, The fourth strut extending proximally is located proximal to the second strut extending proximally, The second proximal joint is close to the first proximal joint, and The first and second proximal joints are circumferentially aligned.

10. The artificial valve according to claim 9, wherein when the artificial valve is in the expanded state, for each pair of circumferentially adjacent intermediate nodes: the smaller rhombus of the artificial valve frame is defined by (1) the distal portions of the first and second distally extending struts and (2) the first and second intermediate struts, the larger rhombus of the artificial valve frame is defined by (1) the first and second distally extending struts and (2) the first and second proximally extending struts, and the largest rhombus of the artificial valve frame is defined by (1) the first and second distally extending struts and (2) the third and fourth proximally extending struts, wherein the smaller rhombus is located within the larger rhombus, and the larger rhombus is located within the largest rhombus.

11. The artificial valve according to claim 9, wherein, A part of the plurality of struts includes a first part of the plurality of struts, wherein the artificial valve frame includes a second part of the plurality of struts, wherein the second part of the plurality of struts is a proximal strut, and wherein for each intermediate node: (i) The first proximal strut extends proximally from the middle position of the first strut among the two struts that extend proximally in opposite directions among the at least six struts, and (ii) the second proximal strut extends proximally from the middle position of the second strut among the two struts that extend proximally in opposite directions among the at least six struts. The middle position of each of the first and second struts among the two struts that extend proximally in opposite directions is located between the intermediate node and the respective proximal end of each of the first and second struts among the two struts that extend proximally in opposite directions, The first and second proximal struts converge at the proximally directed joint of the first and second proximal struts, The proximally directed joint of the first and second proximal struts is circumferentially aligned with the intermediate node, and The proximally directed joint is circumferentially offset relative to the second proximal joint.

12. The artificial valve according to claim 11, wherein, The proximally directed joint is longitudinally aligned with the second proximal joint at the proximal end of the artificial valve frame.

13. The artificial valve according to claim 9, wherein each intermediate node has at least eight struts extending therefrom, wherein, The two struts extending distally in opposite directions are the first two struts among the at least eight struts that extend distally in opposite directions, and wherein, for each pair of circumferentially adjacent intermediate nodes: (i) The third strut extending distally from one of the intermediate nodes in the pair converges with (ii) the fourth strut extending distally from the other intermediate node in the pair at the distal joint, The third strut extending distally is located distal to the first strut extending distally, and The fourth distally extending strut is located at the distal end of the second distally extending strut.

14. An artificial valve configured for transcatheter implantation, the artificial valve comprising: An artificial valve frame that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in a deployed state; and A plurality of artificial valve leaflets located within the lumen and arranged to facilitate unidirectional fluid flow through the lumen from inflow to outflow in a proximal-to-distal direction when the artificial valve is in a deployed state, wherein the artificial valve frame: Has a proximal end located at the inflow end of the artificial valve frame, Has a distal end located at the outflow end of the artificial valve frame, Includes a plurality of struts, Shaped to define a plurality of distal nodes located at the distal end of the frame, and Shaped to define a plurality of intermediate nodes that (1) are located intermediate the proximal and distal ends of the artificial valve frame and (2) are circumferentially offset relative to the distal nodes, wherein a portion of the plurality of struts are reinforcement struts, wherein each intermediate node has at least four struts extending therefrom, including (a) a pair of two distally extending struts of the at least four struts, and (b) a pair of two proximally extending struts of the at least four struts, wherein (i) a first reinforcement strut extends proximally from an intermediate position of the first of the pair of two distally extending struts, and (ii) a second reinforcement strut extends proximally from an intermediate position of the second of the pair of two distally extending struts, the intermediate position of each of the first and second of the pair of two distally extending struts being located between the intermediate node and the respective distal end of each of the first and second of the pair of two distally extending struts, wherein the first and second reinforcement struts converge at a proximal-pointing joint of the first and second reinforcement struts, and wherein (1) the proximal-pointing joint of the first and second reinforcement struts and (2) the intermediate node are circumferentially aligned.

15. The artificial valve according to claim 14, wherein, The artificial valve frame has an overall height of 20 - 26 mm in a deployed state.

16. The artificial valve according to any one of claims 14 - 15, wherein, Each distal node has at least two struts extending therefrom, the at least two struts including a pair of two proximally extending struts from the distal node, and for each pair of circumferentially adjacent distal nodes: A first proximally extending strut from one distal node of the pair of distal nodes converges at an outflow joint with (ii) a second proximally extending strut from the other distal node of the pair of distal nodes, and wherein (1) the outflow joint, (2) the proximal-pointing joint of the first and second reinforcement struts, and (3) the corresponding intermediate node are circumferentially aligned.

17. The artificial valve according to claim 16, wherein each distal node has at least four struts extending therefrom, wherein the two struts extending proximally from the pair of distal nodes define a first pair of struts extending proximally from the distal nodes, wherein the at least four struts of the distal nodes include a second pair of struts extending proximally from the distal nodes, and wherein, For each pair of circumferentially adjacent distal nodes, the outflow joint defines a first outflow joint: A third proximally extending strut from one distal node of the pair of distal nodes converges at a second outflow joint with (ii) a third proximally extending strut from the other distal node of the pair of distal nodes, and The first and second outflow joints are circumferentially aligned.

18. The artificial valve according to claim 17, wherein, Each distal node has at least five struts extending therefrom, and Among them, the at least five struts include a vertical strut that extends proximally from a distal node between (1) a strut extending proximally from the first and third distal nodes and (2) a strut extending proximally from the second and fourth distal nodes.

19. The artificial valve according to claim 17, wherein the first and second outflow joints meet at an outflow node.

20. An artificial valve configured for transcatheter implantation, the artificial valve comprising: An artificial valve frame assembly, comprising: An inner frame that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in a deployed state; and An outer frame coupled to and surrounding the inner frame, wherein the inner frame includes a plurality of inner frame struts arranged in a double-strut form, where two inner frame struts are arranged side by side with each other, and wherein the outer frame includes a plurality of outer frame struts arranged in a multi-strut form, where two or more outer frame struts are arranged side by side with each other; and A plurality of artificial leaflets located within the lumen of the inner frame and arranged to facilitate unidirectional flow of fluid through the lumen from inflow to outflow in a proximal-to-distal direction when the prosthetic valve is in a deployed state.

21. The artificial valve according to claim 20, wherein, The overall height of the artificial valve frame in the deployed state is 20 - 26 mm.

22. The artificial valve according to any one of claims 20-21, wherein the plurality of outer frame struts are arranged in a double-strut form, wherein two outer frame struts are arranged side by side with each other.

23. The artificial valve according to any one of claims 20-21, wherein the plurality of outer frame struts are arranged in a triple-strut form, wherein three outer frame struts are arranged side by side with each other.

24. An artificial valve configured for transcatheter implantation, the artificial valve comprising: (a) An artificial valve frame assembly, comprising: An inner frame that surrounds a central longitudinal axis of the artificial valve to define a lumen along the axis when the artificial valve is in a deployed state and includes a plurality of inner frame struts; and An outer frame surrounding the inner frame and including a plurality of outer frame struts; and (b) A plurality of artificial leaflets located within the lumen of the inner frame and arranged to facilitate unidirectional flow of fluid through the lumen from inflow to outflow in a proximal-to-distal direction when the artificial valve is in a deployed state, wherein the inner frame is shaped to define a plurality of pairs of inner frame struts that converge at corresponding inner frame joints pointing in the proximal direction, and the plurality of pairs of inner frame struts are circumferentially arranged to engage an inflow surface of a native valve of a patient, wherein the outer frame is shaped to define a plurality of pairs of outer frame struts that converge at corresponding outer frame joints pointing in the proximal direction, and the plurality of pairs of outer frame struts are circumferentially arranged to engage an outflow surface of the native valve, wherein each outer frame joint is circumferentially aligned with a corresponding inner frame joint, wherein the plurality of pairs of inner frame struts and the plurality of pairs of outer frame struts are configured to engage leaflets of the native valve between corresponding pairs of inner frame struts and outer frame struts, and wherein the outer frame is shaped to define at least four pairs of outer frame struts and at least four outer frame joints.

25. The artificial valve according to claim 24, wherein, When the artificial valve is in a deployed state, the overall height of the artificial valve frame is 20 - 26 mm.

26. The artificial valve according to any one of claims 24-25, wherein the outer frame is shaped to define at least six pairs of outer frame struts and at least six outer frame joints.

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