Transcatheter heart valve prostheses

Abstract

A transcatheter aortic valve prosthesis includes a frame and a prosthetic valve disposed within the frame. The frame includes a plurality of struts, a plurality of crowns at an inflow end, a plurality of crowns at an outflow end, a plurality of commissure posts, a plurality of first cells, and an access cell. The prosthetic valve includes a plurality of valve leaflets disposed within the frame, wherein a commissure is formed where two valve leaflets of the plurality of valve leaflets are attached to each other and each commissure is secured to a corresponding commissure post of the plurality of commissure posts. An upstream end of the access cell extends to a nadir of a corresponding valve leaflet of the plurality of leaflets of the prosthetic valve.

Description

DktNo. A0012913W001TRANSCATHETER HEART VALVE PROSTHESESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No.63 / 749,277, filed January 24, 2025, the entire content of which is incorporated herein by reference.FIELD

[0002] The present invention relates to transcatheter aortic valve prostheses that facilitate access to a patient’s coronary arteries.BACKGROUND

[0003] The human heart is a four-chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs into systemic circulation. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atrium and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The valve leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness,DktNo. A0012913W001fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0005] Heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0006] The present disclosure relates to improvements in heart valve prostheses for improving the cardiac function of a patient suffering from coronary artery disease. More particularly, the present disclosure relates to transcatheter aortic valve prostheses that provide improved access to a patient’s coronary arteries if the patient requires a percutaneous coronary intervention procedure post-implantation of the transcatheter aortic valve prosthesis.BRIEF SUMMARY OF THE INVENTION

[0007] The techniques and devices of this disclosure generally relate to a transcatheter aortic valve prosthesis.

[0008] In an example hereof, the present disclosure relates to a transcatheter aortic valve prosthesis for replacement of a native heart valve. The transcatheter aortic valve prosthesis comprises: a frame having a plurality of struts, a plurality of crowns at an inflow end, a plurality of crowns at an outflow end, a plurality of commissure posts, a plurality of first cells, and an access cell; a prosthetic valve including a plurality of valve leaflets disposed within the frame, wherein a commissure is formed where two valve leaflets of the plurality of valve leaflets are attached to each other and each commissure is secured to a corresponding commissure post of the plurality of commissure posts of the frame; wherein an upstream end of the access cell extends to a nadir of a corresponding valve leaflet of the prosthetic valve.DktNo. A0012913W001

[0009] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the frame includes exactly twelve crowns at the inflow end and exactly six crowns at the outflow end.

[0010] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the frame includes exactly three access cells and the inflow end of each access cell extends to a nadir of a corresponding valve leaflet of the prosthetic valve.

[0011] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the access cell is diamond shaped.

[0012] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the access cell is heart-shaped.

[0013] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the transcatheter aortic valve prosthesis further comprises a skirt coupled to an inflow portion of the frame, wherein the plurality of valve leaflets are coupled to the skirt along a margin of attachment, and an upstream end of the margin of attachment wear a nadir of one of the leaflets is coupled to the skirt is located at an upstream end of the access cell.

[0014] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the access cell comprises three access cells and the prosthetic valve comprises three valve leaflets, and upstream ends of the margin of attachment corresponding to the nadirs of each valve leaflet are located at the upstream ends of the access cells.

[0015] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the access cell comprises a plurality of first access cells and a plurality of second access cells, and the frame comprises: exactly five rows of first cells in an inflow portion of the frame; exactly one row of the first access cells, wherein the upstream ends of the first access cells extend to the nadirs of corresponding valve leaflets of the prosthetic valve; exactly one row of second access cells downstream of the exactly one row of first access cells; and exactly one row of first cells downstream of the exactly one row of second access cells.

[0016] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the plurality of crowns at the inflow end comprise anDktNo. A0012913W001inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflow end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and the frame further comprises a plurality of rows of nodes / connections disposed between the inflow of crowns and the outflow row of crowns.

[0017] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the first access cells are defined by: a first node in a second row of nodes / connections from the inflow end of the frame; two struts extending distally and away from each other from the first node in the second row of nodes; two tristrut connections in a third row of nodes / connections from the inflow end, wherein the two tri-strut connections in the third row are at distal ends of the two struts extending from the first node; two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections; two nodes in a fourth row of nodes / connections from the inflow end, wherein the two nodes in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row; two struts extending distally and towards each other from the two nodes in the fourth row of nodes / connections; two dual strut connections in a fifth row of nodes / connections from the inflow end, wherein the dual strut connections in the fifth row are at corresponding distal ends of the two struts extending from the nodes in the fourth row; two struts extending distally and towards each other from the two dual strut connections in the fifth row of nodes / connections; and a tri-strut connection in a sixth row of nodes / connections from the inflow end, wherein the tri-strut connection in the fifth row is at corresponding distal ends of the two struts extending from the dual strut connections in the fifth row.

[0018] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the plurality of commissure posts comprises exactly three commissure posts, wherein the frame further comprises exactly three axial struts, and wherein each axial strut is disposed between a corresponding pair of the commissure posts such that the commissure posts and the axial struts alternate around a circumferent of the frame.DktNo. A0012913W001

[0019] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, downstream ends of the first access cells are defined by a corresponding axial strut of the three axial struts.

[0020] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, each of the second access cells is disposed circumferentially between a commissure post of the three commissure posts and an axial strut of the three axial struts.

[0021] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the frame comprises: exactly five rows of first cells in an inflow portion of the frame; exactly one row of the access cells, wherein the upstream ends of the access cells extend to the nadirs of corresponding valve leaflets of the prosthetic; and exactly one row of first cells downstream of the exactly one row of access cells.

[0022] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the plurality of crowns at the inflow end comprise an inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflow end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and wherein the frame further comprises a plurality of rows of nodes / connections disposed between the inflow row of crowns and the outflow row of crowns.

[0023] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the access cells are defined by: a first node in a second row of nodes / connections from the inflow end of the frame; two struts extending distally and away from each other from the first node in the second row of nodes; two tri-strut connections in a third row of nodes / connect! on from the inflow end, wherein the two tri-strut connections in the third row are at distal ends of the two struts extending from the first node; two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections; two tri-strut connections in a fourth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row; two struts extending distally and away from each other from the two tri-strut connections in the fourth row of nodes / connections; two tri-strut connections in a fifth row of nodes / connections from the inflow end, wherein the two tri-DktNo. A0012913W001strut connections in the fifth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the fourth row; two struts extending distally and away from each other from the two tri-strut connections in the fifth row of nodes / connections; two tri-strut connections in a sixth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the sixth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the fifth row; two commissure posts of the plurality of commissure posts, the commissure posts extending distally and substantially parallel to a central longitudinal axis of the frame from the two tri-strut connections in the sixth row; two tri-strut connections in a seventh row of nodes / connections from the inflow end, wherein the two tri-strut connections in the seventh row are at corresponding distal ends of the two commissure posts extending from the tri-strut connections in the sixth row; two struts extending distally and towards each other from the two tri-strut connections in the seventh row of nodes / connections; two nodes in an eighth row of nodes / connections from the inflow end, wherein the two nodes in the eighth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the seventh row; two struts extending proximally and towards each other from the two nodes in the eight row of nodes; and one crown formed where proximal ends of the two struts extending proximally and towards each other from the two nodes in the eight row of nodes meet each other.

[0024] In another example hereof, in the transcatheter aortic valve prosthesis of any of the preceding or following examples, the plurality of commissure posts comprises exactly three commissure posts, wherein no axial struts are disposed circumferentially between the commissure posts.

[0025] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0026] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the presentDktNo. A0012913W001disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings are not to scale.

[0027] FIG. 1 depicts a perspective view of a transcatheter aortic valve prosthesis in a deployed configuration according to embodiments hereof.

[0028] FIG. 2 depicts an as-cut, laid-open, flattened view of the transcatheter aortic valve prosthesis of FIG. 1.

[0029] FIG. 3 depicts a side view of a frame of the transcatheter aortic valve prosthesis of FIG. 1.

[0030] FIG. 4 depicts a laid-open, flattened view of the frame of the transcatheter aortic valve prosthesis of FIG. 1.

[0031] FIG. 5 depicts a side view of the frame of the transcatheter aortic valve prosthesis of FIG. 1.

[0032] FIG. 6 depicts a side view of a transcatheter aortic valve prosthesis in a deployed configuration according to embodiments hereof.

[0033] FIG. 7 depicts a laid-open, flattened view of the transcatheter aortic valve prosthesis of FIG. 6.

[0034] FIG. 8 depicts a side view of the frame of the transcatheter aortic valve prosthesis FIG. 6.

[0035] FIG. 9 depicts a laid-open, flattened view of the frame of the transcatheter aortic valve prosthesis of FIG. 6.

[0036] FIG. 10 depicts a side view of the frame of the transcatheter aortic valve prosthesis FIG. 6.DETAILED DESCRIPTION

[0001] Specific embodiments of the present disclosure are now described with reference to the figures wherein like reference numbers indicate identical or functionally similar elements. The following detailed description describes examples of embodiments of the invention and is not intended to limit the present technology or the application and uses of the present technology. There is no intention to be bound by any expressed or implied theory presented in the preceding Field, Background, Brief Summary, or the following Detailed Description.

[0002] The terms “distal” and “proximal,” when used in the following description to refer to a native vessel, a native valve, or an implanted valve prosthesis are with reference to theDktNo. A0012913W001direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow.

[0037] In addition, the term “self-expanding” is used in the following description with reference to one or more stent structures is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive examples of self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.

[0038] Embodiments hereof are related to transcatheter aortic valve prostheses which are configured to improve access to a patient’s coronary arteries if the patient requires a percutaneous coronary intervention (PCI) procedure post-implantation of the transcatheter aortic valve prosthesis. More particularly, frames of the transcatheter aortic valve prostheses described herein include one or more enlarged cells or side openings, referred to herein as access cells, which are disposed adjacent to a nadir or base of a corresponding valve leaflet of the transcatheter aortic valve prosthesis and of sufficient size to be easily crossed with a coronary guide catheter into either the right coronary artery or the left main coronary artery once the transcatheter aortic valve prosthesis is deployed in situ.

[0039] FIGS. 1-5 depict an embodiment of a transcatheter aortic valve prosthesis 100 in a radially expanded or deployed configuration. The transcatheter aortic valve prosthesis 100 is configured transition between a radially collapsed or delivery configuration and to return to the radially expanded configuration when deployed. When the transcatheter aortic valve prosthesis 100 is in the radially collapsed delivery configuration, the transcatheter aortic valve prosthesis 100 has a low profile suitable for delivery to a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of an aortic valve of a heart via any suitable approach. In embodiments, the transcatheter aortic valve prosthesis 100 includes a frame 110 and a prosthetic valve 150 disposed within and coupled to theDktNo. A0012913W001frame 110. The transcatheter aortic valve prostheses described herein may be similar to transcatheter aortic valve prostheses described in U.S. Patent Application Publication No.2022 / 0175521 to Medtronic, Inc., which is incorporated by reference herein in its entirety.

[0040] As shown in FIG. 1, the frame 110 includes a central lumen 112 extending from an inflow end 114 to an outflow end 116. The frame 110 includes a plurality of struts 118 that are arranged to form a plurality of cells or side openings arranged circumferentially around a longitudinal axis LA of the transcatheter aortic valve prosthesis 100 and longitudinally to form a tubular structure, as shown in FIGS. 1-3. The struts 118 are defined herein as the elongated wire segments of the frame 110 that extend between crowns 120 or nodes 122 of the frame 110. In the embodiment shown, the plurality of cells includes a plurality of first cells 124, a plurality of first access cells 126, and a plurality of second access cells 127. The frame 110 secures the transcatheter aortic valve prosthesis 100 in place in situ within the vasculature of the patient.

[0041] As can be seen in FIG. 3, a row n of struts 118i of the plurality of struts 118 is arranged at the inflow end 114 of the frame 110 such that adjacent struts 118i of the first row n come together to form a row of inflow crowns 120 Ao at the inflow end 114 of the frame 110. While the frame 110 is shown in FIGS. 1-6 with twelve inflow crowns 12OAo, this is not meant to be limiting. The inflow end 114 of the frame 110 also forms an inflow end of the transcatheter aortic valve prosthesis 100. A row rx of struts 118s of the plurality of the struts 118 is arranged at the outflow end 116 of the frame 110 such that adj acent struts 118s of the row rs come together to form outflow crowns 120B9 at the outflow end 116 of the frame 110. As best shown in FIG. 6, the frame 110 includes six outflow crowns 120B9 formed at the outflow end 116 of the frame 110, but this is not meant to be limiting. The outflow end 116 of the frame 110 also forms an outflow end of the transcatheter aortic valve prosthesis 100.

[0042] As described in more detail below, exactly two struts come together to form a dual-strut connection 129, exactly three struts 118 come together to form a tri-strut connection 128, and exactly four struts 118 come together to form a node 122. The dualstrut connections 129 generally appear to as elongated struts. The tri-strut connections 128 are generally Y-shaped and the nodes 122 are generally X-shaped or H-shaped, as can be seen in FIG. 4. The first cells 124, the first access cells 126, and the second access cells 127DktNo. A0012913W001are defined as the open spaces or windows formed between the plurality of struts 118, dualstrut connections 129, tri-strut connections 128, crowns 120, and / or nodes 122.

[0043] In embodiments herein, the frame 110 is self-expanding and may be formed of stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. A suitable biocompatible material is selected such that the transcatheter aortic valve prosthesis 100 may be compressed into a reduced-diameter configuration for transcatheter delivery to a native valve, whereby release from a delivery system returns the transcatheter aortic valve prosthesis 100 to an expanded, deployed configuration. Alternatively, the transcatheter aortic valve prosthesis 100 may be balloon-expandable, as would be understood by one of ordinary skill in the art.

[0044] The frame 110 of the transcatheter aortic valve prosthesis 100 includes the plurality of the first cells 124 arranged circumferentially around the central longitudinal axis LA of the transcatheter aortic valve prosthesis 100 and longitudinally to form a tubular structure. Each first cell 124 of the plurality of first cells 124 is formed by exactly four struts 118 and four nodes 122; or exactly four struts 118, three nodes 122, and one crown 120; or exactly four struts 118, three nodes 122, and one tri-strut connection 128. In the embodiment shown, each first cell 124 is generally diamond shaped. In embodiments, the plurality of first cells 124 vary in size depending on the position of the first cell 124 within the frame 110, z.e., row placement and / or longitudinal position on the frame 110. For example, in some embodiments, the plurality of first cells 124 disposed near the inflow end 114 are smaller than the plurality of first cells 124 disposed at or near the outflow end 116 of the frame 110.

[0045] The frame 110 of the transcatheter aortic valve prosthesis 100 includes a plurality of the first access cells 126 arranged circumferentially around the central longitudinal axis LA of the transcatheter aortic valve prosthesis 100. The frame 110 of the transcatheter aortic valve prosthesis 100 also includes a plurality of the second access cells 127 arranged circumferentially around the central longitudinal axis LA of the transcatheter aortic valve prosthesis 100. Each first access cell 126 is formed by exactly eight struts 118, three nodes 122, three tri-strut connections 128, and three dual-strut connections 129. In the embodiment shown, each first access cell 126 is generally diamond shaped. Each second access cell 127 is formed by exactly six struts 118, two axial struts 130, two nodes 122, five tri-strutDktNo. A0012913W001connections 128, and one dual-strut connection 129. The term “axial strut” is used herein to describe a strut that runs substantially parallel to the longitudinal axis of the transcatheter aortic heart valve. In other words, an axial strut does not have a substantially diagonal disposition, but rather, has 0° of tilt and runs axially with respect to the longitudinal axis of the prosthesis. In the embodiment shown, each second access cell 127 is generally hexagonal - shaped .

[0046] In FIGS. 3-4, subscripts have been added to the reference numerals for the crowns 120, the struts 118, the nodes 122, the dual-strut connections 129, the tri-strut connections 128, the first cells 124, the first access cells 126, and the second access cells 127 to indicate the row number of each type of frame component starting with the inflow end 114.

[0047] Thus, in the embodiment shown, starting at the inflow end 114 of the frame 110, a row Ro of inflow crowns 12OAo defines the inflow end 114 of the frame 110. As noted above, the row Ro includes exactly twelve inflow crowns 12OAo. Upstream of and coupled to the row Ro of inflow crowns 12OAo is a row n of struts 118i such that the upstream ends of adjacent struts 118i form the inflow crowns 12OAo. Arow Ri of nodes 1221 is formed at downstream ends of adjacent struts 118i of the row n of struts 118i and upstream ends of adjacent struts 1182 of a row n of struts 1182. The row Ri of nodes 122i includes exactly twelve nodes 122i. Arow R2 of nodes 1222 is formed at downstream ends of adjacent struts 1182 of the row n of struts 1182 and upstream ends of adjacent struts 1183 of a row n of struts 1183. The rowR2 of nodes 1222 includes exactly twelve nodes 1222. ArowRs of nodes 1223 and tri-strut connections 1283 is formed at downstream ends of adjacent struts 1183 of the row n of struts 1183 and upstream ends of adjacent struts 1184 of a row n of struts 1184. As can been seen in FIG. 4, some of the struts 1184 of the row n of struts are missing as compared to the row n of struts 1183. Thus, the upstream ends of where these “missing” struts 1184 would have been located form the tri-strut connections 1283 of the row R3. The tri-strut connections 1283 define a portion of the first access cells 126, as described in more detail below. The row R3 of nodes 1223 and tri-strut connections 1283 includes exactly six nodes 1223 and six tri-strut connections 1283.

[0048] A row R4 of nodes 1224 is formed at downstream ends of adjacent struts 1184 of the row n of struts 1184 and upstream ends of adjacent struts 1185 of a row rs of struts 1185. In the location of the first access cells 126, the nodes are removed / not included and strutsDktNo. A0012913W001II84 and 1185 are removed / not included. Thus, the row R4 of nodes 1224 includes exactly nine nodes 1224 around the circumference of the frame 110.

[0049] A row Rs of tri-strut connections 128s and dual strut connections 129s is formed at downstream ends of adjacent struts 1185 of the row rs of struts 1185 and upstream ends of adjacent struts 118e of a row re of struts 118e. In the locations where struts 1185 and struts 118e meet at dual-strut connections 129s, the struts 1185 and 118e define a portion of both a first access cell 126 and a second access cell 127. The row R5 includes six tri-strut connections 128s and six-dual strut connections 129s around the circumference of the frame 110.

[0050] A row Re of tri-strut connections 128e is formed at downstream ends of adjacent struts 1186 of the row re of struts 118e and upstream ends of a row rro of axial struts 13Oo. A row R7 of tri-strut connections 128? is formed at downstream ends the axial struts 13Oo of the row rro and upstream ends of adjacent struts 1187 of a row n of struts 1187. Each of the rows Re and R7 includes exactly six tri-strut connections 128e, 128?, respectively. In the embodiment of FIGS. 1-5, the frame includes exactly six axial struts 130, three of which are commissure posts 132. Commissure posts 132 are axial struts 130 to which commissures of the prosthetic valve are coupled. In the embodiment, commissure posts 132 and noncommissure axial struts 130 alternate around the circumference of the frame 110.

[0051] A row Rs of nodes 122s is formed at downstream ends of adjacent struts 1187 of the row n of struts 1187 and upstream ends of adjacent struts 118s of a row rs of struts 118s. The row Rs of nodes 122s includes exactly six nodes 122s.

[0052] At the outflow end 116 of the frame 110 a row R9 of outflow crowns 120B9 is formed at downstream ends of adjacent struts 118s of the row rs of struts 118s. The row R9 of outflow crowns I2OB9 defines the outflow end 116 of the frame 110. In the embodiment of FIGS. 1-5, two tabs are shown extending from corresponding outflow crowns 120B9. The tabs couple the transcatheter aortic heart valve prosthesis 100 to a delivery system. In the embodiment of FIGS. 1-5, a first tab is axially aligned with one of the commissure posts 132 and a second tab is disposed circumferentially 180° apart from the first tab and is axially aligned with a non-commissural axial strut 130. However, this is not meant to be limiting, and the frame 110 may include more or fewer tabs, including no tabs or three tabs as shown in the embodiment of FIGS. 6-10. One or both of the tabs may include a radiopaque marker,DktNo. A0012913W001with one of the tabs including a reflection asymmetric radiopaque marker, such as the C-shaped radiopaque marker shown.

[0053] In the embodiment shown, the frame 110 includes a total of seven rows of cells. A row RCi of first cells 124i is defined at the inflow end 114 of the frame 110, with each first cell 124i being defined by an inflow crown 12OAo, two struts 118i of the row n of struts 1181, two nodes 122i of the row Ri of nodes 122i, two struts 1182 of the row n of struts 1182, and one node 1222 of the row R2 of nodes 1222. There are twelve first cells 124i in the row RCi of cells around the circumference of the frame 110.

[0054] A row RC2 of first cells 1242 is disposed adjacent to and downstream of the row RCi of cells 124i. Each first cell 1242 is defined by a node 122i of the row Ri of nodes, two struts 1182 of the row n of struts 1182, two nodes 1222 of the row R2 of nodes 1222, two struts 1183 of the row n of struts 1183, and one node 1223 of the row R3 of nodes 1223. There are twelve first cells 1242 in the row RC2 of cells around the circumference of the frame 110.

[0055] A row RC3 of first cells 1243 is disposed adjacent to and downstream of the row RC2 of cells. Each first cell 1243 in the row RC3 is defined by a node 1222 of the row R2 of nodes, two struts 1183 of the row n of struts 1183, two nodes 1223 of the row R3 of nodes 1223, two struts 1184 of the row n of struts 1184, and one node 1224 of the row R4 of nodes 1224. There are nine first cells 1243 in the row RC3 of cells around the circumference of the frame 110.

[0056] A row RC4 of first cells 1244 is disposed adjacent to and downstream of the row RC3 of cells. Each first cell 1244 in the row RC4 is defined by a node 1223 of the row R3 of nodes, two struts 1184 of the row n of struts 1184, two nodes 1224 of the row R4 of nodes 1224, two struts 1185 of the row rs of struts 1185, and one node 122s of the row Rs of nodes 122s. There are six first cells 1244 in the row RC4 of cells around the circumference of the frame 110.

[0057] A row RCs of cells is disposed adjacent to and downstream of the row RC4 of cells. Each first cell 124s in the row RCs is defined by a node 1224 of the row R4 of nodes / connections, two struts 1185 of the row rs of struts 1185, two tri-strut connections 128s of the row Rs of nodes / connections, two struts 118e of the row re of struts 118e, and one tri-strut connections 128e of the row Re of nodes / connections. In particular, the tri-strut connections 128e at the downstream end of the first cells 124s of the row RCs of cells is atDktNo. A0012913W001an upstream end of a commissure post 132. There are three first cells 124s in the row RCs of cells around the circumference of the frame 110.

[0058] In the embodiment shown, the frame 110 includes three first access cells 126. The first access cells 126 span the rows RC3 to RC5 of cells. A circumferential centerline of the first access cells 126 is aligned with centerlines of the first cells 1244 of the row RC4 of cells. Therefore, the first access cells 126 may be referred to as being part of the row RC4 of cells (z.e., first access cells 1264). The first access cells 1264 are enlarged cells relative to the first cells 124 at or near the inflow end 114 of the frame 110. Each first access cell 1264 is generally diamond shaped with the upstream end of the diamond disposed adjacent to a nadir or base of a valve leaflet 152 of the prosthetic valve 150 of the transcatheter aortic valve prosthesis 100. In the embodiment shown, each first access cell 1244 is rotationally or circumferentially aligned with a non-commissural axial strut 130 (z.e., a longitudinal centerline of each first access cell 1244 is aligned with a non-commissural axial strut 130). Thus, each first access cell 126A4 is circumferentially disposed between adjacent commissure posts 132. Each first access cell 126A4 is configured to improve access to a patient’s coronary arteries if a percutaneous coronary intervention procedure is required post-implantation of transcatheter aortic valve prosthesis 100. When attempting such a postimplantation percutaneous coronary intervention, a guidewire or catheter attempting to access a coronary artery tends to track to the nadir or base of the valve leaflet. Thus, locating the first access cells 124 adjacent to the nadirs or bases of the valve leaflets 152 improves post-implantation access to the coronary arteries.

[0059] As shown in FIGS. 3 and 4, the three first access cells 1264 are equally spaced around the circumference of the frame 110. Each first access cell 1264 is defined by one node 1222 in the row R2, two struts 1183 in the row n, two tri-strut connections 1283 in the row R3, two struts 1184 in the row n, two nodes 1224 in the row R4, two struts 1185 in the row rs, two dual-strut connections 129s in the row R5, two struts 118e in the row re, and one tri-strut connection 128e in the row Re. As noted above, the two struts 1185, 118e and the dual strut connections 129s connecting them appear as two elongated struts. The tri-strut connection 128e for each first access cell 1264 is between downstream ends of the two struts 118e of the row re and an upstream end of one of the non-commissural axial struts 130. Further, the node 1222 in the row R2 defines an upstream end of the corresponding first access cell 1264 and is axially aligned with the corresponding non-commissural post 130DktNo. A0012913W001defining a downstream end of the first access cell 1264. Circumferentially between adjacent first access cells 1264 are first cells 1243, 1244, and 124s in the rows RC3, RC4, and RC5, respectively.

[0060] In the embodiment shown, the frame 110 includes a total of one row of second access cells 127e at the row RCe of cells. Each second access cell 127e is defined by a node 1224 in the row R4, two struts 1185 in the row rs, two struts 118e in the row re, one tri-strut connection 128s in the row R5, one dual-strut connection 129s in the row R5 (the tri-strut connection 128s and dual-strut connection 129s connect struts 1185 to corresponding struts 118e), two tri-strut connections 128e in the row Re, two axial struts 130e in the row re (one of which is a commissure post and one of which is a non-commissural axial strut), two tri-strut connections 128? in the row R7, two struts 1187 in the row n, and one node 122s in the row Rs. The row RCe of second access cells 127e is disposed between the row R4 of nodes 1224 and the row Rs of nodes 122s.

[0061] A row RC7 of first cells 124? is disposed adjacent to and downstream of the row RCe of second access cells 127e. Each first cell 124? in the row RC7 is defined by a tri-strut connection 128? of the row R7 of nodes / connections, two struts 1187 of the row n of struts 1187, two nodes 122? of the row R7 of nodes / connections, two struts 118s of the row rs of struts 118s, and one outflow crown 120B9 of the row R9 of nodes / connections. In particular, the tri-strut connections 128? at the upstream end of the first cells 124? of the row RC7 of cells is at a downstream end of an axial strut 130. There are six first cells 124? in the row RC7 of cells around the circumference of the frame 110.

[0062] The prosthetic valve 150 of the transcatheter aortic valve prosthesis 100 is disposed within the central lumen 112 of the frame 110 and coupled thereto. The prosthetic valve 150 may include three valve leaflets 152, as shown in FIG. 1. In embodiments, the prosthetic valve includes three valve leaflets 152 and a skirt 154, which is shown in FIG. 1. In embodiments, the three valve leaflets 152 may be securely attached along their bases to the skirt 154 at a joint line or margin of attachment 158. The margin of attachment 158 is also a location where the valve leaflets 152 and the skirt 154 are attached to the frame 110. In the embodiment of FIGS. 1-5, the margin of attachment 158 follows an upstream portion of the first access cells 126 such that upstream ends of the margin of attachment 158 corresponding to the nadir of the valve leaflets 152 are located at the upstream ends of the first access cells 128. Adjoining pairs of valve leaflets 152 are attached to one another atDktNo. A0012913W001their lateral ends to form leaflet commissures 156, which are attached to corresponding commissure posts 132. Alternatively, the transcatheter aortic valve prosthesis 100 may include more or fewer than three valve leaflets. The three valve leaflets 152 may be securely attached along their bases to the skirt 154 and the prosthetic valve 150 is coupled to the frame 110 by methods as described in U.S. Patent Application Publication No.2022 / 0175521 to Medtronic, Inc., incorporated by reference herein in its entirety. The prosthetic valve 150 regulates flow therethrough via the plurality of valve leaflets 152 that may form a replacement valve. When deployed in situ, the prosthetic valve 150 in a closed state is configured to block blood flow in one direction to regulate blood flow through a lumen 112 of the frame 110. The prosthetic valve 150 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0063] The skirt 154 of the prosthetic valve 150 may be coupled to the interior surface of the frame 110 through any suitable manner known in the art, such as sewing the skirt 154 to the frame 110 using sutures. In embodiments, the skirt 154 may comprise three pieces attached together, or may be a single piece. The skirt 154 lines an interior surface of the frame 110 such that the first cells 124 disposed near the inflow end 114 of the frame 110 are covered by the skirt 154. The skirt 154 directs blood flow through the central lumen 112 of the transcatheter aortic valve prosthesis 100 and to the valve leaflets 152 of the prosthetic valve 150. The skirt 154 may be formed of various flexible materials including, but not limited to, natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials.

[0064] FIG. 5 depicts the frame 110 of the transcatheter aortic valve prosthesis 100 with horizontal lines denoting corresponding to rows of nodes / crowns where various measurements have been recorded, however this is not meant to be limiting. For example, for a nominal size 30 mm transcatheter aortic valve prosthesis 100, the diameter DO of theDktNo. A0012913W001frame 110 at horizontal line 170 (row Ro of crowns 120A0) may be 30.4 mm+ / - 15%, or may be in a range of 29.9-30.4 mm. The diameter DI of the frame 110 at horizontal line 171 (row Ri of nodes 1221) may be 29.1 mm + / - 15%, or may be in a range of 28.6-29.6 mm. The distance LI between horizontal line 170 and horizontal line 171 may be 4.7 mm + / -10%, or may be in a range of 4.2-5.2 mm. The diameter D2 of the frame 110 at horizontal line 172 (row R2 of nodes 1222) may be 26.6 mm + / - 15%, or may be in a range of 26.1-27.1 mm. The distance L2 between horizontal line 171 and horizontal line 172 may be 4.5 mm + / - 10%, or may be in a range of 4.1-5.0 mm. The diameter D3 of the frame 110 at horizontal line 173 (row R3 of nodes 1223) may be 23.5 mm + / - 15%, or may be in a range of 23.0-24.0 mm. The distance L3 between horizontal line 172 and horizontal line 173 may be 3.7 mm + / - 10%, or may be in a range of 3.3-4.1 mm. The diameter D4 of the frame 110 at horizontal line 174 (row R4 of nodes 1224) may be 22.0 mm + / - 15%, or may be in a range of 21.5-22.5 mm. The distance L4 between horizontal line 173 and horizontal line 174 may be 4.0 mm + / - 10%, or may be in a range of 3.6-4.4 mm. The diameter D5 of the frame 110 at horizontal line 175 (row R5 of nodes 122s) may be 22.8 mm + / - 15%, or may be in a range of 22.3-23.3 mm. The distance L5 between horizontal line 174 and horizontal line 175 may be 4.1 mm + / - 10%, or may be in a range of 3.7-4.5 mm. The diameter D6 of the frame 110 at horizontal line 176 (row R6 of nodes 122e) may be 23.4 mm + / - 15%, or may be in a range of 22.9-23.9 mm. The distance L6 between horizontal line 175 and horizontal line 176 may be 2.7 mm + / - 10%, or may be in a range of 2.5-3.0 mm. The diameter D7 of the frame 110 at horizontal line 177 (row R7 of nodes 122?) may be 27.7 mm + / - 15%, or may be in a range of 26.2-29.2 mm. The distance L7 between horizontal line 176 and horizontal line 177 may be 4.5 mm + / - 15%, or may be in a range of 3.8-5.2 mm. The diameter D8 of the frame 110 at horizontal line 178 (row R8 of nodes 122s) may be 31.4 mm + / - 15%, or may be in a range of 29.9-32.9 mm. The distance L8 between horizontal line 177 and horizontal line 178 may be 6.4 mm + / - 15%, or may be in a range of 5.4-7.3 mm. The diameter D9 of the frame 110 at horizontal line 179 (row R9 of crowns I2OB9) may be 30.5 mm + / - 15%, or may be in a range of 29.0-32.0 mm. The distance L9 between horizontal line 178 and horizontal line 179 may be 7.6 mm + / - 15%, or may be in a range of 6.4-8.7 mm. The total height Hl of the frame 310, measured from the inflow end 114 to the outflow end 116 may be 42.2 mm + / - 15%, or may be in a range of 37.1-47.3 mm.DktNo. A0012913W001

[0065] In embodiments herein, the six rows of struts 118 at the inflow portion of the frame 110 provide suitable structural support such that the first access cells 1264 may be enlarged to improve post implantation coronary access.

[0066] FIGS. 6-10 depict an embodiment of a transcatheter aortic valve prosthesis 300 according to embodiments hereof. The transcatheter aortic valve prosthesis 300 includes a frame 310 and a prosthetic valve 350 coupled to the frame. The frame 310 includes enlarged access cells 326, portions of which are adjacent to a nadir of a corresponding valve leaflet of the prosthetic valve 350. The transcatheter aortic valve prosthesis 300 is similar to the transcatheter aortic valve prosthesis 300 shown in FIGS. 1-5 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS.6-10. The transcatheter aortic valve prosthesis 300 of FIGS. 6-10 differs from the transcatheter aortic valve prosthesis 100 of FIGS. 1-5 in that the access cells 326 of the transcatheter aortic valve prosthesis 300 are configured differently from the access cells 126, 127 of FIGS. 1-5.

[0067] In the non-limiting embodiment shown in FIGS. 6-10, the frame 310 of the transcatheter aortic valve prosthesis 300 includes six rows of first cells 324 and one row of access cells 326, wherein the one row of access cells 326 includes three access cells 326. In the embodiment shown, the frame 310 includes twelve inflow crowns 320A formed at the inflow end 314 of the frame 310 and six outflow crowns 320B formed at the outflow end 316 of the frame 310, but this is not meant to be limiting.

[0068] As shown in FIG. 6, the transcatheter aortic valve prosthesis 300 includes the frame 310 having the inflow end 314 and the outflow end 316, and a prosthetic valve 350 disposed within the frame 310. The frame 310 includes a plurality of struts 318 that are arranged to form a plurality of cells arranged circumferentially around a central longitudinal axis LA of the transcatheter aortic valve prosthesis 300 and longitudinally to form a tubular structure. The struts 318 are defined as the elongated wire segments of the frame 310. In the embodiment shown in FIGS. 5-10, the plurality of cells include the plurality of first cells 324 and a plurality of access cells 326. The access cells 326 each have an enlarged area relative to or compared to the first cells 324. The prosthetic valve 350 is disposed within a central lumen 312 of the frame 310, and the prosthetic valve 350 is attached to the frame 310. The frame 310 secures the transcatheter aortic valve prosthesis 300 in place in situ within the vasculature of the patient.DktNo. A0012913W001

[0069] As can be seen in FIG. 8, the plurality of struts 318 are arranged at the inflow end 314 of the frame 310 such that two adjacent struts 318 of the plurality of struts 318 come together to form a crown 320 at the inflow end 314. Thus, a row or plurality of inflow crowns 320A are formed at the inflow end 314 of the frame 310. As best shown in FIG. 9 and FIG.11, in this embodiment the frame 310 includes exactly twelve inflow crowns 320A at the inflow end 314 of the frame 310, but this is not meant to be limiting. The inflow end 314 of the frame 310 also forms an inflow end of the transcatheter aortic valve prosthesis 300. The plurality of the struts 318 are arranged at the outflow end 316 of the frame 310 such that two adjacent struts 318 of the plurality of struts 318 come together to form a crown 320 at the outflow end 316. The frame 310 includes exactly six outflow crowns 320B formed at the outflow end 316 of the frame 310, but this is not limiting. The outflow end 316 of the frame 310 also forms an outflow end of the transcatheter aortic valve prosthesis 300. Exactly three struts 318 come together to form a tri-strut connection 328, and exactly four struts 318 come together to form a node 322, as can be seen in FIG. 9. The first cells 324 and the access cells 326 are defined as the open spaces or windows formed between the plurality of struts 318, tri-strut connections 328, crowns 320, and / or nodes 322. The frame 310 is selfexpanding and may be formed from any of the materials listed above for the frame 110.

[0070] Each first cell 324 of the plurality of first cells 324 is formed by: exactly four struts 318 and exactly one crown 320 and three nodes 322; or exactly four struts 318 and exactly four nodes 322; or exactly four struts 318 and exactly three nodes 322 and one tri-strut connection 328; or exactly four struts 318 and exactly two nodes 322 and two tri-strut connections 328; or exactly four struts 318 and exactly one tri-strut connection 328 and two nodes 322 and one crown 320; or exactly four struts 318 and exactly two crowns 320 and two nodes 322. In embodiments, the plurality of first cells 324 are generally diamond shaped and vary in size depending on the position of the first cell 324 within the frame 310, i.e., row placement and / or longitudinal position on the frame 310. For example, in some embodiments, the plurality of first cells 324 disposed near the outflow end 316 of the frame 310 may be larger than the plurality of first cells 324 disposed at the inflow end 314 and a midline or midportion of the frame 310. In the embodiment described herein, each access cell 326 is heart shaped and is larger than each first cell 324 of the plurality of first cells 324.DktNo. A0012913W001

[0071] The frame 310 of the transcatheter aortic valve prosthesis 300 is described herein for illustrative purposes in terms of horizontal rows of crowns 320, nodes 322 and / or tristrut connections 328, horizontal rows of struts 318, and horizontal rows of cells 324, 326. Each row of struts is disposed between two adjacent rows of the crowns, nodes, and / or tristrut connections. Each row of cells is defined by struts, crowns, nodes, and or tri-strut connections, as described above. In FIGS. 8 and 9, subscripts have been added to the reference numerals for the crowns 320, nodes 322, tri-strut connections 328, struts 318, commissure posts 332, first cells 324, and access cells 326 to indicate the row number of each type of frame component starting with the inflow end 314.

[0072] The frame 310 includes a total of ten rows of crowns 320, nodes 322, and tri-strut connections 328, as shown in FIG. 9, and eight rows of struts 318, as shown in FIGS. 8 and 9. Thus, in the embodiment shown, starting at the inflow end 314 of the frame 310, a row Ro of inflow crowns 32OAo defines the inflow end 314 of the frame 310. As noted above, the row Ro includes exactly twelve inflow crowns 32OAo. Upstream of the row Ro of inflow crowns 32OAo is a row n of struts 318i such that the upstream ends of adjacent struts 318i form the inflow crowns 120 Ao (z.e., the inflow crowns 120 Ao are formed where the upstream ends of adjacent struts 318i meet). A row Ri of nodes 322i is formed at downstream ends of adjacent struts 318i of the row n of struts 318i and upstream ends of adjacent struts 3182 of a row r2 of struts 3182. The row Ri of nodes 322i includes exactly twelve nodes 3221. A row R2 of nodes 3222 is formed at downstream ends of adjacent struts 3182 of the row n of struts 3182 and upstream ends of adjacent struts 3183 of a row n of struts 3183. The row R2 of nodes 3222 includes exactly twelve nodes 3222. A row R3 of nodes 3223 and tri-strut connections 3283 is formed at downstream ends of adjacent struts 3183 of the row n of struts 3183 and upstream ends of adjacent struts 3184 of a row n of struts 3184. As can been seen in FIG. 9, some of the struts 3184 of the row n of struts are missing as compared to the row r3 of struts 3183. Thus, the upstream ends of where these “missing” struts 3184 would have been located form the tri-strut connections 3283 of the row R3. The tri-strut connections 3283 define a portion of the access cells 326, as described in more detail below. The row R3 of nodes 3223 and tri-strut connections 3283 includes exactly six nodes 1223 and six tri-strut connections 3283.

[0073] A row R4 of nodes 3224 and tri-strut connections 3284 is formed at downstream ends of adjacent struts 3184 of the row n of struts 3184 and upstream ends of adjacent strutsDktNo. A0012913W001318s of a row rs of struts 318s. In the location of the access cells 326, some struts 3184 and 318s are removed / not included such that some of the nodes are not included and some are tri-strut connections 3284. Thus, the row R4 includes exactly three nodes 3224 and exactly six tri-strut connections 3284 around the circumference of the frame 310.

[0074] A row Rs of tri-strut connections 328s is formed at downstream ends of adjacent struts 3185 of the row rs of struts 3185 and upstream ends of adjacent struts 318e of a row re of struts 318e. There are twelve struts 3185 in the row rs and six struts 318e in the row re. Thus, the row Rs of tri-strut connections 328s includes exactly six tri-strut connections 328s around the circumference of the frame 310. Due to the fewer number of struts 318 than in corresponding rows adjacent the inflow end 314, a portion of the access cells 326 are defined in area between tri-strut connections 328s, as described in more detail below.

[0075] A row Re of tri-strut connections 328e is formed at downstream ends of adjacent struts 318e of the row re of struts 318e and upstream ends of a row rro of commissure posts 332o. In the embodiment of FIGS. 6-10, there are exactly three commissure posts 332 and there are no axial struts that are not commissures posts. Thus, as compared to the embodiment of FIGS. 1-5, the embodiment of FIGS. 6-10 does not include the axial struts disposed between adjacent commissure posts. Thus, instead of three commissures posts and three non-commissural axial struts, as shown in the embodiment of FIGS. 1-5, the embodiment of FIGS. 6-10 includes three commissure posts and zero non-commissural axial struts. Thus, the area where the axial struts 130 of FIGS. 1-5 are located is open in the embodiment of FIGS. 6-10 and forms part of the access cells 326, as described below.

[0076] A row R7 of tri-strut connections 328? is formed at downstream ends of commissure struts 332o of the row rro and upstream ends of adjacent struts 3187 of a row n of struts 3187. Each of the rows Re and R7 includes exactly three tri-strut connections 328e, 3287, respectively. In the embodiment of FIGS. 6-10, the frame 310 includes exactly three commissure posts 332, and does not include axial struts as described in the embodiment of FIGS. 1-5. Because of the lack of non-commissural axial struts, the upstream ends of the struts 3187 of the row n of struts that are not connected to the commissure posts 332 form crowns 320C, as shown in FIGS. 7-9. In other words, the upstream ends of adjacent struts 3187 of the row n of struts meet either at downstream end of a commissure post 332 or at a crowns 320C. Further, the commissure posts 332 are spaced such that each crown 320C is disposed between different adjacent pairs of commissure posts 332. In other words, theDktNo. A0012913W001commissure posts 332 and the crowns 320C alternate around a circumference of the frame 310.

[0077] A row R8 of nodes 322s is formed at downstream ends of adjacent struts 318? of the row n of struts 318? and upstream ends of adjacent struts 318s of a row rx of struts 318s. The row Rs of nodes 322s includes exactly six nodes 322s.

[0078] At the outflow end 316 of the frame 310 a row R9 of outflow crowns 320B9 is formed at downstream ends of adjacent struts 318s of the row rs of struts 318s. The row R9 of outflow crowns 320B9 defines the outflow end 316 of the frame 310. In the embodiment of FIGS. 6-10, there are exactly six outflow crowns 320B9. In the embodiment of FIGS. 6-10, three tabs are shown extending from corresponding outflow crowns 320B9. The tabs couple the transcatheter aortic heart valve prosthesis 300 to a delivery system. In the embodiment of FIGS. 6-10, each tab is axially aligned with one of the commissure posts 332. However, this is not meant to be limiting, and the frame 310 may include more or fewer tabs, including no tabs or two tabs as shown in the embodiment of FIGS. 1-5. One or more of the tabs may include a radiopaque marker, with one of the tabs including a reflection asymmetric radiopaque marker, such as the C-shaped radiopaque marker shown.

[0079] As explained briefly above, the frame 310 includes rows of first cells 324 and access cells 326 defined by struts, crowns, and tri-strut connections. In the embodiment of FIGS. 6-10, the frame 310 includes a total of seven rows of cells, including exactly six rows of first cells 324 and exactly one row of access cells 326, as best shown in FIGS. 8 and 9.

[0080] A row RCi of first cells 324i is defined at the inflow end 314 of the frame 310, with each first cell 324i being defined by an inflow crown 32OAo, two struts 3181 of the row n of struts 3181, two nodes 322i of the row Ri of nodes 3221, two struts 3182 of the row n of struts 3182, and one node 3222 of the row R2 of nodes 3222. There are twelve first cells 324i in the row RCi of cells around the circumference of the frame 310.

[0081] A row RC2 of first cells 3242 is disposed adjacent to and downstream of the row RCi of cells 324i. Each first cell 3242 of the RC2 is defined by a node 3221 of the row Ri of nodes, two struts 3182 of the row n of struts 3182, two nodes 3222 of the row R2 of nodes 3222, two struts 3183 of the row n of struts 3183, and one node 3223 of the row R3 of nodes 3223. There are twelve first cells 3242 in the row RC2 of cells around the circumference of the frame 310.DktNo. A0012913W001

[0082] A row RC3 of first cells 3243 is disposed adjacent to and downstream of the row RC2 of cells. There are nine first cells 3243 in the row R3 of cells around the circumference of the frame 310. Three of the first cells 3243 in the row RC3 are each defined by a node 3222 of the row R2 of nodes, two struts 3183 of the row n of struts 3183, two nodes 3223 of the row R3 of nodes 3223, two struts 3184 of the row n of struts 3184, and one node 3224 of the row R4 of nodes 3224. Six of the first cells 3243 of the RC3 (those adjacent to the access cells 326 described below) are each defined by a node 3222 of the row R2 of nodes, two struts 3183 of the row n of struts 3183, one node nodes 3223 and one adjacent tri-strut connection 3283 of the row R3 of nodes / connections, two struts 3184 of the row n of struts 3184, and one tri-strut connection 3284 of the row R4 of nodes / connections.

[0083] A row RC4 of first cells 3244 is disposed adjacent to and downstream of the row RC3 of cells. Each first cell 3244 in the row RC4 is defined by a node 3223 of the row R3 of nodes, two struts 3184 of the row n of struts 3184, one nodes 3224 and an adjacent tri-strut connection 3284 of the row R4 of nodes / tr-strut connections, two struts 3185 of the row rs of struts 3185, and one tri-strut connection 328s of the row Rs of tri-strut connections. There are six first cells 3244 in the row RC4 of cells around the circumference of the frame 310.

[0084] A row RCs of cells is disposed adjacent to and downstream of the row RC4 of cells. Each first cell 324s in the row RCs is defined by a node 3224 of the row R4 of nodes / connections, two struts 318s of the row rs of struts, two tri-strut connections 328s of the row Rs of nodes / connections, two struts 318e of the row re of struts, and one tri-strut connection 328e of the row Re of nodes / connections. In particular, the tri-strut connections 328e at the downstream end of the first cells 324s of the row RCs of cells are at an upstream end of a commissure post 332. There are three first cells 324s in the row RCs of cells around the circumference of the frame 310.

[0085] In the embodiment shown, the frame 310 includes three access cells 326. The access cells 326 span the rows RC2 to RCs of cells and extend to the row Rs nodes 322s. Thus, the row of access cells 326 are labeled as a row RC6 of access cells 326e. The access cells 326e are enlarged cells relative to the first cells 324 at or near the inflow end 314 of the frame 310 and the first cells 324 at the outflow end 316 of the frame 310. Each access cell 326e is generally heart shaped with a proximal or inflow end of each access cell 326e is disposed adjacent to a nadir or base of a valve leaflet 352 of the prosthetic valve 350 of the transcatheter aortic valve prosthesis 300. In the embodiment shown, each access cell 326eDktNo. A0012913W001is disposed circumferentially between a corresponding pair of commissure struts 332. Each access cell 326e is configured to improve access to a patient’s coronary arteries if a percutaneous coronary intervention procedure is required post-implantation of transcatheter aortic valve prosthesis 300. When attempting such a post-implantation percutaneous coronary intervention, a guidewire or catheter attempting to access a coronary artery tends to track to the nadir or base of the valve leaflet. Thus, having large access cells 326 with inflow ends thereof adjacent to the nadirs or bases of the valve leaflets 352 improves postimplantation access to the coronary arteries.

[0086] As shown in FIGS. 8 and 9, the three access cells 326e are equally spaced around the circumference of the frame 310. Each access cell 326e is defined by one node 3222 in the row R2, two struts 3183 in the row n, two tri-strut connections 3283 in the row R3, two struts 3184 in the row n, two tri-strut connections 3284 in the row R4, two struts 3185 in the row rs, two trio-strut connections 328s in the row R5, two struts 318e in the row re, two tri-strut connections 328e in the row Re, two commissure posts 332o in the row rro, two tri-strut connections 328? in the row R7, four struts 3187 in the row n, two nodes 322s in the row Rs, and two crowns 320C. As can be seen in FIG. 9, the crowns 320C are longitudinally aligned with the tri-strut connections 328? in the row R7, which are located at the downstream ends of the commissure posts 332. Circumferentially between adjacent access cells 326e are first cells 3243, 3244, and 324s in the rows RC3, RC4, and RCs, respectively.

[0087] A row RC7 of first cells 324? is disposed adjacent to and downstream of the row RCe of access cells 326e. Three first cells 324? in the row RC7 are each defined by a tri-strut connection 328? of the row R7 of nodes / connections, two struts 3187 of the row n of struts 3187, two nodes 322s of the row Rs of nodes / connections, two struts 318s of the row rs of struts 318s, and one outflow crown 320B9 of the row R9 of nodes / connections. In particular, the tri-strut connections 328? at the upstream end of three of the first cells 324? of the row RC7 of cells is at a downstream end of a commissure post 332. Three first cells 324? in the row RC7 are each defined by a crown 320C? of the row R7 of nodes / connections, two struts 3187 of the row n of struts 3187, two nodes 322s of the row Rs of nodes / connections, two struts 318s of the row rs of struts 318s, and one outflow crown 320B9 of the row R9 of nodes / connections. Each of the three first cells 324? having a crown 320C? defining the upstream end thereof is disposed between a corresponding pair of first cells 324? having a tri-strut connections 328? defining a downstream end of a commissure post 332o definingDktNo. A0012913W001the upstream end thereof. In other words, first cells 324? at the crowns 320C? at the upstream end thereof alternate around the circumference of the frame 310 with first cells 324? with tri-strut connections 328? at the upstream ends. There are six total first cells 324? in the row R.7 of cells around the circumference of the frame 310.

[0088] The prosthetic valve 350 is disposed inside and coupled to an interior surface of the frame 310 of the transcatheter aortic valve prosthesis 300, as shown in FIGS. 6 and 7. In embodiments, the prosthetic valve 350 includes three valve leaflets 352 and a skirt 354, as shown in FIG. 6. In embodiments, the three valve leaflets 352 may be securely attached along their bases to the skirt 354 at a joint line or margin of attachment 358. The margin of attachment 358 is also a location where the valve leaflets 352 and the skirt 354 are attached to the frame 310. In the embodiment of FIGS. 6-10, the margin of attachment 358 follows an upstream portion of the access cells 326 such that upstream ends of the margin of attachment 358 corresponding to the nadir of the valve leaflets 352 are located at the upstream ends of the access cells 328. Similar to the previous embodiment, the three valve leaflets 352 may be sewn using sutures or otherwise securely attached along their bases to the skirt as described in U.S. Patent Application Publication No. 2022 / 0175521 to Medtronic, Inc., which has been previously incorporated by reference herein in its entirety. The prosthetic valve 350 is configured to block flow in one direction to regulate flow therethrough via the valve leaflets 352 that form a replacement bicuspid or tricuspid valve. The prosthetic valve 350 may be coupled to the frame 310 in any suitable manner known in the art, such as sewing the prosthetic valve 350 to the frame 310 using sutures (not shown) as described in U.S. Patent Application Publication No. 2022 / 0175521 to Medtronic, Inc., which has been previously incorporated by reference herein in its entirety. Adjoining pairs of valve leaflets 352 are attached to one another at their lateral ends to form commissures 356. Each of the three axial struts 330 acts as a commissure posts 332 that align with and attach to a respective commissure 356 of the three valve leaflets 352 of the prosthetic valve 350. The prosthetic valve 350 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet withDktNo. A0012913W001a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0089] FIG. 10 depicts the frame 310 of the transcatheter aortic valve prosthesis 200 with horizontal lines denoting where various measurements have been recorded, however this is not meant to be limiting. For example, the diameter DO of the frame 310 at horizontal line 370 (row Ro of crowns 32OAo) may be 30.4 mm + / - 15%, or may be in a range of 29.9-30.9 mm. The diameter DI of the frame 310 at horizontal line 371 (row Ri of nodes 3221) may be 29.1 mm + / - 15%, or may be in a range of 28.6-29.6 mm. The distance LI between horizontal line 370 and horizontal line 371 may be 4.7 mm + / - 10%, or may be in a range of 4.2-5.2 mm. The diameter D2 of the frame 310 at horizontal line 372 (row Ri of nodes 3222) may be 26.6 mm + / - 15%, or may be in a range of 26.1-27.1 mm. The distance L2 between horizontal line 371 and horizontal line 372 may be 4.5 mm + / - 10%, or may be in a range of 4.1-5.0 mm. The diameter D3 of the frame 310 at horizontal line 373 (row R3 of nodes 3223, connections 3283) may be 23.5 mm + / - 15%, or may be in a range of 23.0-24.0 mm. The distance L3 between horizontal line 372 and horizontal line 373 may be 3.7 mm + / - 10%, or may be in a range of3.3-4.1 mm. The diameter D4 of the frame 310 at horizontal line 374 (row R4 of nodes 3224, connections 3284) may be 22.0 mm + / - 15%, or may be in a range of 12.5-22.5 mm. The distance L4 between horizontal line 373 and horizontal line 374 may be 4.0 mm + / - 10%, or may be in a range of 3.6-4.4 mm. The diameter D5 of the frame 310 at horizontal line 375 (row Rs of connections 328s) may be 22.8 mm + / - 15%, or may be in a range of 22.3-23.3 mm. The distance L5 between horizontal line 374 and horizontal line 375 may be 4.1 mm + / - 10%, or may be in a range of 3.7-4.5 mm. The diameter D6 of the frame 310 at horizontal line 376 (row Re of connections 328e) may be 23.4 mm + / - 15%, or may be in a range of 22.9-23.9 mm. The distance L6 between horizontal line 375 and horizontal line 376 may be 2.7 mm + / - 10%, or may be in a range of 2.5-3.0 mm. The diameter D7 of the frame 310 at horizontal line 377 (row R7 of connections 328?, crowns 320C?) may be 27.7 mm + / - 15%, or may be in a range of 26.2-29.2 mm. The distance L7 between horizontal line 376 and horizontal line 377 may be 4.5 mm + / - 15%, or may be in a range of 3.8-5.2 mm. The diameter D8 of the frame 310 at horizontal line 378 (row Rs of nodes 322s) may be 31.4 mm + / - 15%, or may be in a range of 29.9-32.9 mm. The distance L8 between horizontal line 377 and horizontal line 378 may be 6.4 mm + / - 15%, or may be in a range of 5.4-7.3 mm. The diameter D9 of the frame 310DktNo. A0012913W001at horizontal line 379 (row R9 of crowns 32OB9) may be 30.5 mm + / - 15%, or may be in a range of 29.0-32.0 mm. The distance L9 between horizontal line 378 and horizontal line 379 may be 7.6 mm + / - 15%, or may be in a range of 6.4-8.7 mm. The total height Hl of the frame 310, measured from the inflow end 314 to the outflow end 316 may be 42.2 mm + / -15%, or may be in a range of 37.1-47.3 mm.

[0090] While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present technology, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present technology. Thus, the breadth and scope of the present technology should not be limited by any of the above-described embodiments but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, may be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

[0091] The following examples are illustrative of the techniques described herein.

[0092] Example 1. A transcatheter aortic valve prosthesis for replacement of a native heart valve, the transcatheter aortic valve prosthesis comprising: a frame having a plurality of struts, a plurality of crowns at an inflow end, a plurality of crowns at an outflow end, a plurality of commissure posts, a plurality of first cells, and an access cell; and a prosthetic valve including a plurality of valve leaflets disposed within the frame, wherein a commissure is formed where two valve leaflets of the plurality of valve leaflets are attached to each other and each commissure is secured to a corresponding commissure post of the plurality of commissure posts of the frame, and wherein an upstream end of the access cell extends to a nadir of a corresponding valve leaflet of the prosthetic valve.

[0093] Example 2. The transcatheter aortic valve prosthesis of Example 1, wherein the frame includes exactly twelve crowns at the inflow end and exactly six crowns at the outflow end.

[0094] Example 3. The transcatheter aortic valve prosthesis of Example 1 or Example 2, wherein the frame exactly three access cells, wherein the inflow end of each access cell extends to a nadir of a corresponding valve leaflet of the prosthetic valve.DktNo. A0012913W001

[0095] Example 4. The transcatheter aortic valve prosthesis of any one of Examples 1 to 3, wherein the access cell is diamond shaped.

[0096] Example 5. The transcatheter aortic valve prosthesis of any one of Examples 1 to 3, wherein the access cell is heart shaped.

[0097] Example 6. The transcatheter aortic valve prosthesis of any one of Examples 1 to 5, further comprising a skirt coupled to an inflow portion of the frame, wherein the plurality of valve leaflets are coupled to the skirt along a margin of attachment, and wherein an upstream end of the margin of attachment where a nadir of one of the leaflets is coupled to the skirt is located at an upstream end of the access cell.

[0098] Example 7. The transcatheter aortic valve prosthesis of Example 6, wherein the access cell comprises three access cells and the prosthetic valve comprises three valve leaflets, and wherein upstream ends of the margin of attachment corresponding to the nadirs of each valve leaflet are located at the upstream ends of the access cells.

[0099] Example 8. The transcatheter aortic valve prosthesis of Example 1, wherein the access cell comprises a plurality of first access cells and a plurality of second access cells, wherein the frame comprises: exactly five rows of first cells in an inflow portion of the frame; exactly one row of the first access cells, wherein the upstream ends of the first access cells extend to the nadirs of corresponding valve leaflets of the prosthetic valve; exactly one row of second access cells downstream of the exactly one row of first access cells; and exactly one row of first cells downstream of the exactly one row of second access cells.

[0100] Example 9. The transcatheter aortic valve prosthesis of Example 8, wherein the plurality of crowns at the inflow end comprise an inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflow end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and wherein the frame further comprises a plurality of rows of nodes / connections disposed between the inflow row of crowns and the outflow row of crowns.

[0101] Example 10. The transcatheter aortic valve prosthesis of Example 9, wherein the first access cells are defined by: a first node in a second row of nodes / connections from the inflow end of the frame; two struts extending distally and away from each other from the first node in the second row of nodes; two tri-strut connections in a third row of nodes / connection from the inflow end, wherein the two tri-strut connections in the third rowDktNo. A0012913W001are at distal ends of the two struts extending from the first node; two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections; two nodes in a fourth row of nodes / connections from the inflow end, wherein the two nodes in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row; two struts extending distally and towards each other from the two nodes in the fourth row of nodes / connections; two dual strut connections in a fifth row of nodes / connections from the inflow end, wherein the dual strut connections in the fifth row are at corresponding distal ends of the two struts extending from the nodes in the fourth row; two struts extending distally and towards each other from the two dual strut connections in the fifth row of nodes / connections; and a tri-strut connection in a sixth row of nodes / connections from the inflow end, wherein the tri-strut connection in the fifth row is at corresponding distal ends of the two struts extending from the dual strut connections in the fifth row.

[0102] Example 11. The transcatheter aortic valve prosthesis of any one of Examples 8 to 10, wherein the plurality of commissure posts comprises exactly three commissure posts, wherein the frame further comprises exactly three axial struts, wherein each axial strut is disposed between a corresponding pair of the commissure posts such that the commissure posts and the axial struts alternate around a circumferent of the frame.

[0103] Example 12. The transcatheter heart valve prosthesis of Example 11, wherein downstream ends of the first access cells are defined by a corresponding axial strut of the three axial struts.

[0104] Example 13. The transcatheter heart valve prosthesis of Example 12, wherein each of the second access cells is disposed circumferentially between a commissure post of the three commissure posts and an axial strut of the three axial struts.

[0105] Example 14. The transcatheter aortic valve prosthesis of Example 1, wherein the frame comprises: exactly five rows of first cells in an inflow portion of the frame; exactly one row of the access cells, wherein the upstream ends of the access cells extend to the nadirs of corresponding valve leaflets of the prosthetic valve; and exactly one row of first cells downstream of the exactly one row of access cells.

[0106] Example 15. The transcatheter aortic valve prosthesis of Example 14, wherein the plurality of crowns at the inflow end comprise an inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflowDktNo. A0012913W001end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and wherein the frame further comprises a plurality of rows of nodes / connections disposed between the inflow row of crowns and the outflow row of crowns.

[0107] Example 16. The transcatheter aortic valve prosthesis of Example 15, wherein the access cells are defined by: a first node in a second row of nodes / connections from the inflow end of the frame; two struts extending distally and away from each other from the first node in the second row of nodes; two tri-strut connections in a third row of nodes / connection from the inflow end, wherein the two tri-strut connections in the third row are at distal ends of the two struts extending from the first node; two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections; two tri-strut connections in a fourth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row; two struts extending distally and away from each other from the two tri-strut connections in the fourth row of nodes / connections; two tri-strut connections in a fifth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the fifth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the fourth row; two struts extending distally and away from each other from the two tri-strut connections in the fifth row of nodes / connections; two tri-strut connections in a sixth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the sixth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the fifth row; two commissure posts of the plurality of commissure posts, the commissure posts extending distally and substantially parallel to a central longitudinal axis of the frame from the two tri-strut connections in the sixth row; two tri-strut connections in a seventh row of nodes / connections from the inflow end, wherein the two tri-strut connections in the seventh row are at corresponding distal ends of the two commissure posts extending from the tri-strut connections in the sixth row; two struts extending distally and towards each other from the two tri-strut connections in the seventh row of nodes / connections; two nodes in an eighth row of nodes / connections from the inflow end, wherein the two nodes in the eighth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the seventh row; two struts extendingDktNo. A0012913W001proximally and towards each other from the two nodes in the eight row of nodes; and one crown formed where proximal ends of the two struts extending proximally and towards each other from the two nodes in the eight row of nodes meet each other.

[0108] Example 17. The transcatheter aortic valve prosthesis of any one of Examples 14 to 16, wherein the plurality of commissure posts comprises exactly three commissure posts, wherein no axial struts are disposed circumferentially between the commissure posts.

Claims

1. DktNo. A0012913W001CLAIMS:

1. A transcatheter aortic valve prosthesis for replacement of a native heart valve, the transcatheter aortic valve prosthesis comprising:a frame having a plurality of struts, a plurality of crowns at an inflow end, a plurality of crowns at an outflow end, a plurality of commissure posts, a plurality of first cells, and an access cell, wherein the access cell is larger than than each of the plurality of first cells; anda prosthetic valve including a plurality of valve leaflets disposed within the frame, wherein a commissure is formed where two valve leaflets of the plurality of valve leaflets are attached to each other and each commissure is secured to a corresponding commissure post of the plurality of commissure posts of the frame,wherein an upstream end of the access cell extends to a nadir of a corresponding valve leaflet of the prosthetic valve.

2. The transcatheter aortic valve prosthesis of claim 1, wherein the frame includes exactly twelve crowns at the inflow end and exactly six crowns at the outflow end.

3. The transcatheter aortic valve prosthesis of claim 1 or claim 2, wherein the frame includes exactly three access cells, wherein the inflow end of each access cell extends to a nadir of a corresponding valve leaflet of the plurality of leaflets of the prosthetic valve.

4. The transcatheter aortic valve prosthesis of any one of claims 1 to 3, wherein the access cell is diamond shaped.

5. The transcatheter aortic valve prosthesis of any one of claims 1 to 3, wherein the access cell is heart shaped.

6. The transcatheter aortic valve prosthesis of any one of claims 1 to 5, further comprising a skirt coupled to an inflow portion of the frame, wherein the plurality of valve leaflets are coupled to the skirt along a margin of attachment, and wherein an upstream end of theDktNo. A0012913W001margin of attachment where a nadir of one of the leaflets is coupled to the skirt is located at an upstream end of the access cell.

7. The transcatheter aortic valve prosthesis of claim 6, wherein the access cell comprises three access cells and the prosthetic valve comprises three valve leaflets, and wherein upstream ends of the margin of attachment corresponding to the nadirs of each valve leaflet are located at the upstream ends of the access cells.

8. The transcatheter aortic valve prosthesis of claim 1, wherein the access cell comprises a plurality of first access cells and a plurality of second access cells, wherein the frame comprises:exactly five rows of first cells in an inflow portion of the frame;exactly one row of the first access cells, wherein the upstream ends of the first access cells extend to the nadirs of corresponding valve leaflets of the prosthetic valve; exactly one row of second access cells downstream of the exactly one row of first access cells; andexactly one row of first cells downstream of the exactly one row of second access cells.

9. The transcatheter aortic valve prosthesis of claim 8, wherein the plurality of crowns at the inflow end comprise an inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflow end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and wherein the frame further comprises a plurality of rows of nodes / connections disposed between the inflow row of crowns and the outflow row of crowns.

10. The transcatheter aortic valve prosthesis of claim 9, wherein the first access cells are defined by:a first node in a second row of nodes / connections from the inflow end of the frame; two struts extending distally and away from each other from the first node in the second row of nodes;DktNo. A0012913W001two tri-strut connections in a third row of nodes / connection from the inflow end, wherein the two tri-strut connections in the third row are at distal ends of the two struts extending from the first node;two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections;two nodes in a fourth row of nodes / connections from the inflow end, wherein the two nodes in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row;two struts extending distally and towards each other from the two nodes in the fourth row of nodes / connections;two dual strut connections in a fifth row of nodes / connections from the inflow end, wherein the dual strut connections in the fifth row are at corresponding distal ends of the two struts extending from the nodes in the fourth row;two struts extending distally and towards each other from the two dual strut connections in the fifth row of nodes / connections; anda tri-strut connection in a sixth row of nodes / connections from the inflow end, wherein the tri-strut connection in the fifth row is at corresponding distal ends of the two struts extending from the dual strut connections in the fifth row.

11. The transcatheter aortic valve prosthesis of any one of claims 8 to 10, wherein the plurality of commissure posts comprises exactly three commissure posts, wherein the frame further comprises exactly three axial struts, wherein each axial strut is disposed between a corresponding pair of the commissure posts such that the commissure posts and the axial struts alternate around a circumferent of the frame.

12. The transcatheter heart valve prosthesis of claim 11, wherein downstream ends of the first access cells are defined by a corresponding axial strut of the three axial struts.

13. The transcatheter heart valve prosthesis of claim 12, wherein each of the second access cells is disposed circumferentially between a commissure post of the three commissure posts and an axial strut of the three axial struts.DktNo. A0012913W00114. The transcatheter aortic valve prosthesis of claim 1,wherein the frame comprises:exactly five rows of first cells in an inflow portion of the frame;exactly one row of the access cells, wherein the upstream ends of the access cells extend to the nadirs of corresponding valve leaflets of the prosthetic valve; andexactly one row of first cells downstream of the exactly one row of access cells;wherein the plurality of crowns at the inflow end comprise an inflow row of crowns at the inflow end, the plurality of crowns at the outflow end comprise an outflow row of crowns at the outflow end, the plurality of struts comprise eight rows of struts between the inflow end and the outflow end, and wherein the frame further comprises a plurality of rows of nodes / connections disposed between the inflow row of crowns and the outflow row of crowns; andwherein the access cells are defined by:a first node in a second row of nodes / connections from the inflow end of the frame;two struts extending distally and away from each other from the first node in the second row of nodes;two tri-strut connections in a third row of nodes / connection from the inflow end, wherein the two tri-strut connections in the third row are at distal ends of the two struts extending from the first node;two struts extending distally and away from each other from the two tri-strut connections in the third row of nodes / connections;two tri-strut connections in a fourth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the fourth row are at corresponding distal ends of the two struts extending from the two tri-strut connections in the third row;two struts extending distally and away from each other from the two tri-strut connections in the fourth row of nodes / connections;two tri-strut connections in a fifth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the fifth row are atDktNo. A0012913W001corresponding distal ends of the two struts extending from the tri-strut connections in the fourth row;two struts extending distally and away from each other from the two tri-strut connections in the fifth row of nodes / connections;two tri-strut connections in a sixth row of nodes / connections from the inflow end, wherein the two tri-strut connections in the sixth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the fifth row;two commissure posts of the plurality of commissure posts, the commissure posts extending distally and substantially parallel to a central longitudinal axis of the frame from the two tri-strut connections in the sixth row; two tri-strut connections in a seventh row of nodes / connections from the inflow end, wherein the two tri-strut connections in the seventh row are at corresponding distal ends of the two commissure posts extending from the tri-strut connections in the sixth row;two struts extending distally and towards each other from the two tri-strut connections in the seventh row of nodes / connections;two nodes in an eighth row of nodes / connections from the inflow end, wherein the two nodes in the eighth row are at corresponding distal ends of the two struts extending from the tri-strut connections in the seventh row; two struts extending proximally and towards each other from the two nodes in the eight row of nodes; andone crown formed where proximal ends of the two struts extending proximally and towards each other from the two nodes in the eight row of nodes meet each other.

15. The transcatheter aortic valve prosthesis of claim 14, wherein the plurality of commissure posts comprises exactly three commissure posts, wherein no axial struts are disposed circumferentially between the commissure posts.

Images