Prosthetic heart valve

Abstract

A prosthetic heart valve comprising an annular frame with a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells is disclosed. Adjacent cells in the same row are connected to each other at junctions. Leaflets are disposed within the frame and are configured to regulate a flow of blood through the frame in one direction. An inner skirt is disposed on an inner surface of the frame, where the inner skirt is connected to the frame with at least one suture forming an inner skirt stitch line. The inner skirt stitch line comprises a plurality of first stitches and a plurality of second stitches. The plurality of second stitches extend over outer surfaces of junctions between selected angled struts in regions of the frame facing outflow surfaces of movable portions of the leaflets.

Description

PROSTHETIC HEART VALVE CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 665,155, filed June 27, 2024, and U.S. Provisional Application No.63 / 700,405, filed September 27, 2024, both of which are incorporated by reference herein in their entireties. FIELD

[0002] The present disclosure relates to prosthetic heart valves and to methods and assemblies for attaching skirts to frames of prosthetic heart valves. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents or grafts) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In a specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0005] Many expandable prosthetic heart valves comprise a radially expandable and compressible cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Each leaflet can comprise a main body with a cusp edge portion. The cusp edge portion of each leaflet can be coupled to selected struts of the frame, either directly or through an inner skirt disposed around an inner surface of the frame. The leaflets of theprosthetic heart valve are configured to open and close to regulate a flow of blood through the prosthetic heart valve, from an inflow end to an outflow end of the prosthetic heart valve.

[0006] Inner and outer skirts can be stitched to struts of the frame using sutures, where the stitches can extend around selected struts of the frame for attachment thereto. Some of the stitches coupling the inner skirt to the frame can face an outflow surface of movable portions of the leaflets. In some examples, when the leaflets open under the flow of blood, the leaflets may contact those stitches, causing wear to the leaflets.

[0007] Additionally, when a frame is radially compressed it can lengthen in an axial direction relative to a central longitudinal axis of the frame, which, in turn, can axially pull an outer skirt attached thereto. Depending on how the skirt is stitched to the frame and other components of the prosthetic valve (such as the leaflets), the connection of the skirt to the frame and other components can limit the ability of the skirt to stretch during crimping of the prosthetic valve. SUMMARY

[0008] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are configurations and methods for stitching skirts to a prosthetic valve frame. The disclosed stitching configurations and methods can, for example, minimize contact between stitches and the leaflets of the prosthetic valve. Also described herein are skirts configured to accommodate elongation of the frame when the prosthetic valve is radially compressed. As such, the configurations and methods disclosed herein can, among other things, overcome one or more of the deficiencies of known prosthetic heart valves.

[0009] A prosthetic heart valve can comprise an annular frame and a valvular structure coupled to the frame. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0010] In some examples, a prosthetic heart valve can comprise an inner skirt disposed on an inner surface of the frame.

[0011] In some examples, the annular frame can comprise a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, where adjacent cells in the same row are connected to each other at junctions.

[0012] In some examples, the valvular structure can comprise a plurality of leaflets disposed in the frame and configured to regulate a flow of blood through the frame in one direction.

[0013] In some examples, the inner skirt can be connected to the frame with at least one suture forming a plurality of first stitches that extend around selected angled struts.

[0014] In some examples, the inner skirt can be connected to the frame with at least one suture forming a plurality of second stitches that extend over junctions between the selected angled struts on an outer surface of the frame.

[0015] In some examples, the plurality of second stitches can extend between inside corners of adjacent cells in the same row.

[0016] In some examples, the plurality of first and second stitches can form a skirt stitch line.

[0017] In some examples, each of the second stitches can extend horizontally from one of the first stitches to another one of the first stitches.

[0018] In some examples, each of the plurality of second stitches can extend from one of the first stitches through the inner skirt to the outer surface of the frame, across a junction, and then back through the inner skirt to another one of the first stitches on the inner surface of the frame.

[0019] In some examples, at least one first stitch can extend around each angled strut of the selected angled struts.

[0020] In some examples, at least two consecutive first stitches can extend around each angled strut of the selected angled struts.

[0021] In some examples, exactly two consecutive first stitches can extend around each angled strut of the selected angled struts.

[0022] In some examples, a single second stitch can extend over each junction between the selected angled struts.

[0023] In some examples, the frame can comprise a plurality of horizontal struts forming the junctions and connecting adjacent cells together, wherein each of the plurality of second stitches can extend over one of the horizontal struts on the outer surface of the frame.

[0024] In some examples, the plurality of horizontal struts can connect outside corners of adjacent cells in the same row and the plurality of second stitches can be disposed over outersurfaces of respective horizontal struts that face an outflow surface of movable portions of the leaflets.

[0025] In some examples, each of the plurality of second stitches can extends from a first end of a horizontal strut to a second end of the same horizontal strut only on an outer surface of the annular frame.

[0026] In some examples, the rows of struts can include a first row of struts and a first segment of the skirt stitch line can comprise at least one first stitch on a first strut of the first row of struts, at least one first stitch on a second strut of the first row of struts, at least one first stitch on a third strut of the first row of struts, and at least one first stitch on a fourth strut of the first row of struts.

[0027] In some examples, second stitches can extend over a first junction between the first and second struts, a second junction between the second and third struts, and / or a third junction between the third and fourth struts.

[0028] In some examples, the first, second, third, and fourth struts can face an outer surface of movable portions of the leaflets.

[0029] In some examples, the rows of struts can include a second row of struts upstream of the first row of struts, where the first segment of the skirt stitch line can comprise at least one first stitch on a fifth strut of the second row of struts and at least one first stitch of a sixth strut of the second row of struts, where the fifth strut can be immediately adjacent the first strut and the sixth strut can be immediately adjacent the fourth strut.

[0030] In some examples, the rows of struts can include a third row of struts upstream of the second row of struts, where the first segment of the skirt stitch line can comprise at least one first stitch on a seventh strut of the third row of struts and at least one first stitch on an eighth strut of the third row of struts, where the seventh strut can be immediately adjacent the fifth strut and the eighth strut can be immediately adjacent the sixth strut.

[0031] In some examples, the skirt stitch line can comprise a repeating pattern of the first segment of the skirt stitch line around a circumference of the annular frame.

[0032] In some examples, the repeating pattern can form a continuous skirt stitch line circumferentially around the entire annular frame.

[0033] In some examples, the repeating pattern can comprise at least three repeating first segments around the circumference of the annular frame.

[0034] In some examples, the repeating pattern can comprise exactly three repeating first segments around the circumference of the annular frame.

[0035] In some examples, the repeating pattern can form a zig-zag pattern circumferentially around the annular frame.

[0036] In some examples, the plurality of leaflets can be secured to the annular frame with stitches that extend around selected angled struts forming a leaflet stitch line.

[0037] In some examples, the leaflet stitch line can form an undulating pattern circumferentially around the annular frame.

[0038] In some examples, the annular frame can comprise an inflow end and an outflow end, and the plurality of second stitches can be arranged in a region of the annular frame between the leaflet stitch line and the outflow end.

[0039] In some examples, features of the skirt stitch line can be circumferentially centered about features of the leaflet stitch line.

[0040] In some examples, the first segment of the skirt stitch line has an inverted W shape.

[0041] In some examples, the annular frame can comprise at least three rows of circumferentially extending cells formed by the plurality of angled struts.

[0042] In some examples, the cells can be diamond-shaped cells.

[0043] In some examples, the plurality of first and second stitches can form a skirt stitch line comprising a first segment, a second segment, and a third segment extending circumferentially around the annular frame.

[0044] In some examples, the second segment can be disposed immediately adjacent the first segment on a first side of the first segment.

[0045] In some examples, the third segment can be disposed immediately adjacent the first segment on a second side of the first segment which is opposite the first side.

[0046] In some examples, the first segment can share a first inflow apex with the second segment.

[0047] In some examples, the first segment can share a second inflow apex with the third segment.

[0048] In some examples, the second and third segments can share a third inflow apex.

[0049] In some examples, the first, second, and third segments can be identical to each other.

[0050] In some examples, the prosthetic heart valve can comprise an outer skirt disposed on an outer surface of the frame.

[0051] In some examples, the outer skirt can comprise an inflow edge and an outflow edge.

[0052] In some examples, the outer skirt can be secured to the frame along a first outer skirt stitch line with stitches that extend around selected angled struts.

[0053] In some examples, the first outer skirt stitch line can form a repeating undulating pattern around a circumference of the outer skirt.

[0054] In some examples, first regions of the outer skirt upstream of the first outer skirt stitch line can form slackened portions of the outer skirt when the frame is in a radially expanded state.

[0055] In some examples, second regions of the outer skirt downstream of the first outer skirt stitch line can form slackened portions of the outer skirt when the frame is in a radially expanded state.

[0056] In some examples, the first outer skirt stitch line can form a repeating V-shaped or U- shaped pattern.

[0057] In some examples, the first outer skirt stitch line can comprise a plurality of inflow apices and a plurality of outflow apices that are circumferentially offset from the inflow apices.

[0058] In some examples, the second regions of the outer skirt can be circumferentially aligned with the inflow apices of the first outer skirt stitch line.

[0059] In some examples, the first regions of the outer skirt can be circumferentially aligned with the outflow apices of the first outer skirt stitch line.

[0060] In some examples, the annular frame can comprise a plurality of axial struts extending from a row of angled struts at the outflow end of the frame toward the inflow end of the frame, and the outflow edge of the outer skirt can be secured to the axial struts with a plurality of third stitches.

[0061] In some examples, the plurality of third stitches can form a second outer skirt stitch line that extends circumferentially around the frame.

[0062] In some examples, the inflow edge of the outer skirt can be secured to the frame with a plurality of fourth stitches that extend around apices at the inflow end of the frame.

[0063] In some examples, the plurality of fourth stitches can form a third outer skirt stitch line that extends circumferentially around the annular frame.

[0064] In some examples, first regions of the outer skirt can be in a pulled state when the annular frame is in a radially compressed configuration.

[0065] In some examples, the inflow edge of the outer skirt can define a plurality of extension portions spaced apart from each other by a plurality of valley portions.

[0066] In some examples, the outer skirt can define a plurality of extension portions spaced apart from each other by a plurality of valley portions.

[0067] In some examples, the extension portions of the inflow edge can be offset from the extension portions of the outflow edge in a circumferential direction.

[0068] In some examples, a prosthetic heart valve comprises an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over junctions between the selected angled struts on an outer surface of the frame.

[0069] In some examples, a prosthetic heart valve comprises an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein outside corners of adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a continuous stitch line comprising a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over respective junctions and between inside corners of adjacent cells in the same row, wherein the second stitches extend only on an outer surface of the frame at the junctions.

[0070] In some examples, a prosthetic heart valve comprises an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are separated from each other by horizontal struts; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inside of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected first angled struts and a plurality of second stitches, wherein each of the plurality of second stitches extends from a first end of a horizontal strut to a second end of the same horizontal strut only on an outer surface of the annular frame.

[0071] In some examples, a prosthetic heart valve comprises: an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over junctions between the selected angled struts on an outer surface of the frame.

[0072] In some examples, a prosthetic valve comprises: a radially expandable and compressible, annular frame comprising in inflow end, an outflow end, and a plurality of rows of angled struts disposed between the inflow and outflow ends; a valvular structure comprising a plurality of leaflets disposed within the frame; and an outer skirt disposed on an outer surface of the frame, the outer skirt comprising an inflow edge and an outflow edge, wherein the outer skirt is secured to the frame along a first outer skirt stitch line with first stitches that extend around selected angled struts, wherein the first outer skirt stitch line forms a repeating undulating pattern around a circumference of the outer skirt, and wherein first regions of the outer skirt upstream of the first outer skirt stitch line form slackened portions of the outer skirt when the frame is in a radially expanded state.

[0073] In some examples, a prosthetic valve comprises: a radially expandable and compressible, annular frame comprising an inflow end, an outflow end, and a plurality of rows of angled struts disposed between the inflow and outflow ends; a valvular structure comprising a plurality of leaflets disposed within the frame; and an outer skirt disposed on anouter surface of the frame, the outer skirt comprising an inflow edge and an outflow edge, wherein the inflow edge comprises a plurality of extension portions spaced apart from each other in a circumferential direction by a plurality of valley portions.

[0074] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-44, 54-69, 96-103, and 105 below.

[0075] A skirt for a prosthetic valve can comprise an outflow edge and an undulating inflow edge. In addition to these elements, a skirt for a prosthetic valve can further comprise one or more of the elements disclosed herein.

[0076] In some examples, the undulating inflow edge can extend along a first direction and be disposed a first distance from the outflow edge in a second direction perpendicular to the first direction, wherein the undulating inflow edge can define a plurality of spaced apart extension portions and valley portions.

[0077] In some examples, the outflow edge can be an undulating edge extending along the first direction and can define a plurality of spaced apart extension portions and valley portions.

[0078] In some examples, the extension portions of the outflow edge can be offset from the extension portions of the inflow edge in the first direction.

[0079] In some examples, a midline bisecting each extension portion of the outflow edge can be aligned in the first direction with a midline bisecting an opposing valley portion of an inflow edge.

[0080] In some examples, the inflow and / or the outflow edges can have at least three extension portions and at least three valley portions.

[0081] In some examples, the inflow and / or outflow edges can have exactly three extension portions and three valley portions.

[0082] In some examples, the inflow and / or outflow edges can have exactly four extension portions and four valley portions.

[0083] In some examples, edge portions of the valley portions of the inflow edge can be aligned with each other in the second direction.

[0084] In some examples, edge portions of the valley portions of the outflow edge can be aligned with each other in the second direction.

[0085] In some examples, edge portions of the extension portions of the inflow edge can be aligned with each other in the second direction.

[0086] In some examples, edge portions of the extension portions of the outflow edge can be aligned with each other in the second direction.

[0087] In some examples, the inflow and outflow edges can further define a plurality of inflow and outflow angled portions connecting adjacent extension portions and valley portions.

[0088] In some examples, a skirt for a prosthetic valve comprises an outflow edge extending along a first direction; and an undulating inflow edge extending along the first direction and disposed a first distance from the outflow edge in a second direction perpendicular to the first direction, wherein the undulating inflow edge defines a plurality of spaced apart extension portions and valley portions.

[0089] In some examples, a skirt for a prosthetic valve comprises one or more of the elements recited in Examples 70-88 and 105 below.

[0090] A method of securing an inner skirt to an annular frame of a prosthetic heart valve can comprise arranging the inner skirt on an inner surface of the annular frame. In addition to these steps, a method of securing an inner skirt to an annular frame of a prosthetic heart valve can further comprise one or more of the steps disclosed herein.

[0091] In some examples, the annular frame can comprise a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions.

[0092] In some examples, the method can further comprise securing the inner skirt to the annular frame using at least one suture forming a first stitch line comprising a plurality of first stitches that extend around selected angled struts.

[0093] In some examples, the method can further comprise securing the inner skirt to the annular frame using at least one suture forming a first stitch line comprising a plurality of second stitches that extend over adjacent junctions only on an outer surface of the frame.

[0094] In some examples, a plurality of leaflets of the prosthetic heart valve can be secured to the inner surface of the annular frame along a second stitch line.

[0095] In some examples, the method further can further comprise forming the second stitch line using a plurality of whip stitches extending around adjacent angled struts.

[0096] In some examples, the method can further comprise forming the second stitch line in an undulating pattern circumferentially around the annular frame.

[0097] In some examples, the annular frame can comprise an inflow end and an outflow end, and the method can further comprise forming the plurality of second stitches over junctions in a region of the annular frame between the second stitch line and the outflow end.

[0098] In some examples, the method can further comprise forming the plurality of second stitches on outer surfaces of junctions facing an outflow surface of movable portions of the leaflets.

[0099] In some examples, the method can further comprise forming the plurality of second stitches by extending the at least one suture from one of the first stitches through the inner skirt to the outer surface of the frame, across a junction, and then back through the inner skirt to another one of the first stitches on the inner surface of the frame.

[0100] In some examples, the method can further comprise whip stitching the plurality of first stitches through the inner skirt and around adjacent angled struts.

[0101] In some examples, the method can further comprise forming the first stitch line in a zig-zag pattern circumferentially around the annular frame.

[0102] In some examples, a method of securing an inner skirt to an annular frame of a prosthetic heart valve comprises arranging the inner skirt on an inner surface of the annular frame, wherein the annular frame comprises a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; and securing the inner skirt to the annular frame using at least one suture forming a first stitch line, wherein the first stitch line comprises a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over adjacent junctions only on an outer surface of the frame.

[0103] In some examples, a method of securing an inner skirt to an annular frame of a prosthetic heart valve comprises one or more of the steps recited in Examples 45-54 and 105 below.

[0104] A method of assembling a prosthetic heart valve comprising a frame and an outer skirt can comprise stitching the outer skirt to the frame. In addition to this step, a method of assembling a prosthetic heart valve comprising a frame and an outer skirt can further comprise one or more of the steps disclosed herein.

[0105] In some examples, the outer skirt can have an inflow edge defining a plurality of extension portions spaced from each other by valley portions in a circumferential direction, and after stitching the outer skirt to the frame, the plurality of extension portions can form slack portions in the outer skirt in regions adjacent the extension portions.

[0106] In some examples, the slack portions can be in a loose state when the frame is in a radially expanded configuration and a pulled state when the frame is in a radially compressed configuration.

[0107] In some examples the act of stitching the outer skirt to the frame can comprise stitching along an outer skirt stitch line forming an undulating pattern extending circumferentially around the frame.

[0108] In some examples, the act of stitching the outer skirt to the frame can comprise stitching the plurality of extension portions of the inflow edge of the outer skirt around apices at an inflow end of the frame.

[0109] In some examples the outer skirt has can have an outflow edge defining a plurality of extension portions spaced from each other by valley portions in the circumferential direction.

[0110] In some examples, the extension portions of the outflow edge can be stitched to axial struts of the frame.

[0111] In some examples, the method can further comprise securing a valvular structure comprising a plurality of leaflets to the frame, wherein each leaflet has a cusp edge portion that is secured to the frame with stitches.

[0112] In some examples, a method of assembling a prosthetic heart valve comprising a frame and an outer skirt comprises stitching an outer skirt to the frame, wherein the outer skirt has an inflow edge defining a plurality of extension portions spaced from each other by valley portions in a circumferential direction; and after stitching the outer skirt to the frame, the plurality of extension portions form slack portions in the outer skirt in regions adjacent the extension portions.

[0113] In some examples, a method of assembling a prosthetic heart valve comprising a frame and an outer skirt comprises one or more of the steps recited in Examples 89-95 and 104 below.

[0114] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0115] FIG.1 is a side view of a prosthetic heart valve comprising a frame, according to an example.

[0116] FIG.2 is a perspective view of the frame of the prosthetic heart valve of FIG.1.

[0117] FIG.3 is a side view of the frame of FIG.2, where the frame is shown in a straightened (non-annular) state with an inner skirt stitch line and a leaflet stitch line schematically represented, according to an example.

[0118] FIG.4 is an enlarged view of a portion of the frame of FIG.3, showing inner skirt stitches disposed along the inner skirt stitch line and the leaflet stitch line schematically represented.

[0119] FIG.5 is an enlarged view of a portion of a prosthetic heart valve having the frame of FIG.4, showing stitches for securing an inner skirt to the frame and stitches for securing the leaflets to the frame, as viewed from outside the frame.

[0120] FIG.6 is an enlarged view of a portion of the prosthetic heart valve of FIG.5, as viewed from inside the frame.

[0121] FIG.7 is a side view of a delivery apparatus for a prosthetic heart valve, according to an example.

[0122] FIG.8 is a side view of a prosthetic heart valve, according to an example.

[0123] FIG.9 is a side view of a prosthetic heart valve, according to an example.

[0124] FIG.10 is a plan view of a leaflet assembly in a flat configuration with leaflets of the leaflet assembly secured together with a connecting suture line disposed along a cusp edge portion of each of the leaflets, according to an example.

[0125] FIG.11 is a perspective view of the leaflet assembly of FIG.10.

[0126] FIG.12 is a plan view of one leaflet with a connecting suture line secured to a cusp edge portion of the leaflet.

[0127] FIG.13 is a plan view of an outflow end of a prosthetic heart valve comprising the leaflet assembly of FIG.10 attached to an inside of a frame of the prosthetic heart valve.

[0128] FIG.14 is an interior, perspective view of a portion of an inflow end of the prosthetic heart valve of FIG.13 showing the connecting suture line of the leaflet assembly secured directly to struts of the frame.

[0129] FIG.15A is an exterior, perspective view of a portion of the inflow end of the prosthetic heart valve of FIG.13 showing the connecting suture line of the leaflet assembly secured directly to struts of the frame.

[0130] FIG.15B is a schematic of a cross-sectional view of a leaflet connected to the frame of FIG.15A using the connecting suture line of the leaflet assembly.

[0131] FIG.15C is a schematic of a portion of the connecting suture line of the leaflet assembly and a whip stitch connected to the connecting suture line for connecting the leaflet assembly to the frame of FIG.15A.

[0132] FIG.15D is another schematic showing the connecting suture wrapped around a strut of the frame of FIG.15A and around a portion of the connecting suture line of a leaflet of the leaflet assembly.

[0133] FIG.16 is a perspective view of a portion of the prosthetic heart valve of FIG.13 showing an attachment of an outer skirt to an outer surface of the frame.

[0134] FIG.17 is another perspective view of the portion of the prosthetic heart valve of FIG.13 showing the attachment of the outer skirt to the outer surface of the frame and an attachment interface of the leaflet assembly to the frame.

[0135] FIG.18 is a perspective view from above showing a frame and an outer skirt of a prosthetic heart valve, according to an example, comprising slack and non-slack portions.

[0136] FIG.19 is a perspective view from below of the frame and outer skirt of FIG.18.

[0137] FIG.20 is a side view of the outer skirt of FIG.18, wherein the outer skirt is shown in a straightened (non-annular) state with extension portions and valley portions. DETAILED DESCRIPTION General Considerations

[0138] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0139] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0140] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0141] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein,the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0142] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0143] Described herein are examples of prosthetic heart valves, leaflet assemblies for prosthetic heart valves, prosthetic valve skirts, and methods for assembling leaflet assemblies and skirts to a frame of a prosthetic heart valve. The prosthetic heart valves can comprise a frame with a plurality of struts and a valvular structure attached to the frame. The valvular structure can comprise a plurality of leaflets. In some examples, a cusp edge portion of the leaflets of the valvular structure can be secured to an annular inner skirt using stitches. At least one suture can be used to form the stitches that define a leaflet stitch line circumferentially disposed around the frame. The annular skirt can be secured to selected struts of the frame using at least one suture forming stitches that define a separate, inner skirt stitch line circumferentially disposed around the frame.

[0144] As introduced above, in known prosthetic valves, some of the stitches that secure the inner skirt to the frame can face an outflow surface of movable portions of the leaflets. In some cases, when the leaflets are in an open configuration, the leaflets can contact some of those stitches, leading to leaflet wear.

[0145] Therefore, in some examples, a stitching configuration secures an inner skirt to an inside surface of a prosthetic valve frame while preventing or minimizing leaflet wear.

[0146] Additionally or alternatively, as introduced above, in known prosthetic valves, a frame^(and thus a prosthetic heart valve^comprising the frame) can be crimped into a radially compressed (or crimped) state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. In some cases, when the frame is radially compressed, the frame can axially lengthen relative to a longitudinal axis of the frame. The connection of the skirt to the frame and other components of the prosthetic valve can, in some cases, limit the ability of the skirt to stretch axially as the frame elongates. Assuch, in some examples, it is desirable to configure an outer skirt with extra material and with stitching arrangements that can accommodate axial lengthening of the frame.

[0147] Described herein are examples of prosthetic heart valves that can comprise a radially expandable and compressible annular frame, an inner skirt coupled to the frame, and a valvular structure comprising a plurality of leaflets coupled to the frame. FIG.1 illustrates a prosthetic heart valve comprising an annular frame, an outer skirt, an inner skirt, and a valvular structure comprising a plurality of leaflets, according to an example. FIG.2 shows the annular frame of the prosthetic valve of FIG.1 without the outer skirt, inner skirt, or valvular structure. An example of a leaflet stitch line and an inner skirt stitch line can be seen schematically in FIG.3. FIGS.4-6 show detail views of the stitches forming the inner skirt stitch line and / or the leaflet stitch line, according to an exemplary example. FIG.7 shows an implant delivery apparatus, according to an example. FIGS.8-9 show examples of exemplary prosthetic heart valves. FIGS.10-17 show examples of a leaflet assembly and stitching methods thereof. FIGS.18-19 illustrate a frame with an outer skirt for a prosthetic valve, according to an example, where the outer skirt is configured with slack portions when stitched to the frame. FIG.20 shows the outer skirt of FIGS.18-19 in a flattened, non- annular state with extension and valley portions. Examples of the Disclosed Technology

[0148] Prosthetic heart valves (also referred to herein as “prosthetic valves”) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on a delivery apparatus. The prosthetic valve can be expanded to the radially expanded state (e.g., a deployed state) once the prosthetic valve reaches an implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail below.

[0149] FIG.1 shows an exemplary prosthetic heart valve 100, according to an example. Any of the prosthetic valves disclosed herein can be adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including apulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0150] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No.2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No.2019 / 0000615, which is incorporated by reference herein.

[0151] The prosthetic heart valve 100 of FIG.1 can be radially expandable and compressible between a radially expanded working state and a radially compressed state. In some examples, the prosthetic heart valve 100 can be expandable to any one of a plurality of radially expanded working states that includes a smallest radially expanded working state and a largest radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0152] As shown in FIG.1, the prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104 disposed on an inside of the frame 102, and a perivalvular outer sealing member or outer skirt 106, and an inner skirt 107 in some examples. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 can be disposed around an outer surface 109 of the frame 102.

[0153] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, at commissure tabs 115) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs 115 disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs 115. In some examples, the cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape. In some examples, the cusp edge portions of the leaflets can be secured to the inner skirt 107 and / or to the frame 102 (for example, by sutures) along a leaflet stitch line, as will be described further in more detail below.

[0154] In some examples, the leaflets 112 (and / or any leaflets described herein) can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein in its entirety.

[0155] In some examples, the outer skirt 106 can be an annular skirt. In some examples, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102.

[0156] The inner skirt 107 can be disposed between an inner surface 113 of the annular frame 102 and outer surfaces 116 (i.e., outflow surfaces) of the leaflets 112. In some examples, the inner skirt 107 can comprise one or more skirt portions that are connected together. In some examples, the leaflets 112 can be secured to the frame 102 along a leaflet stitch line formed from a plurality of stitches extending through the inner skirt 107, as will be described in more detail below. In some examples, the inner skirt 107 can be connected directly to the frame 102 with a plurality of stitches along an inner skirt stitch line that is separate from the leaflet stitch line.

[0157] The outer skirt 106 and / or an inner skirt 107 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth,fleece, etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0158] FIG.2 is a perspective view of the frame 102, where the frame 102 is in an exemplary radially expanded (annular) state. FIG.3 shows of the frame 102 in a straightened (non- annular) state.

[0159] The frame 102 and / or any one of the frames disclosed herein can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self- expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame^102^(and thus the prosthetic heart valve^100) can be crimped to a radially compressed (or crimped) state on a delivery catheter, shown in FIG.7, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame^102^(and thus the prosthetic heart valve^100) can be crimped to a radially compressed state and restrained in the radially compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic heart valve^100 can be advanced from the delivery sheath, which allows the prosthetic heart valve^100 to expand to its functional state (for example, any one of the plurality of radially expanded working states).

[0160] Suitable plastically-expandable materials that can be used to form the frame 102 include metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame can comprise stainless steel. In someexamples, the frame can comprise cobalt-chromium. In some examples, the frame can comprise nickel-cobalt-chromium. In some examples, the frame comprises a nickel-cobalt- chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0161] As seen in FIGS.2-3, the frame 102 can comprise a plurality of interconnected struts 117 that form open cells 118 arranged in multiple rows 120, 126, 127, and 128 of cells that extend in a circumferential direction and are disposed between the inflow end 108 and the outflow end 110 of the frame 102. Although FIG.3 shows the annular frame 102 of FIG.2 in a flattened configuration with a first side 170 and a second side 172 shown on opposing ends, it is understood that the first side 170 actually extends directly into the second side 172. In other words, the annular frame 102 is shown cut and flattened for clarity in viewing the multiple rows 120, 126, 127, and 128 of cells 118, and the struts 117 that form the frame 102.

[0162] As shown in FIG.3, the frame 102 can comprise four circumferentially extending rows of cells including a first row 120, a second row 126, a third row 127, and a fourth row 128 with the first (upper in the orientation shown in FIGS.2-3) row 120 disposed at the outflow end 110. In some examples, the first row 120 can comprise cells 118a that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), compared to cells 118b in the remaining rows 126, 127, and 128. In some examples, the cells 118a of the first row 120 may not be elongated relative to the other rows and / or the cells of the other rows (for example, the second, third, and / or fourth rows 126, 127, and / or 128) may be elongated relative to the remaining rows. In some examples, the cells 118 can be diamond-shaped. As shown, the frame 102 includes twelve cells per row 120, 126, 127, and 128. In some examples, the frame 102 can include a greater or fewer number of cells in each row 120, 126, 127, and 128.

[0163] The interconnected struts 117 can include a plurality of angled struts 130, 132, 133, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the axial length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame 102; a second row of circumferentially extending, angled struts 132; a third row of circumferentially extending, angled struts 133; a fourth row of circumferentiallyextending, angled struts 134; and a fifth row of circumferentially extending, angled struts 136 at the outflow end 110 of the frame 102.

[0164] The fifth row of angled struts 136 can be connected to the fourth row of angled struts 134 by a plurality of axially extending commissure supports 138 and a plurality of axial struts 140. The axially extending commissure supports 138 can have an inflow end portion 139 and an outflow end portion 141 and can define commissure windows 142 that are spaced apart from one another around the frame 102 in a circumferential direction.

[0165] As shown in FIG.3, the interconnected struts 117 can also comprise horizontal struts 150 that extend between outside corners 151 of adjacent cells 118 in the same row of cells of the frame 102, forming junctions. The horizontal struts 150 (also referred to herein as “lateral struts”) can extend in a circumferential direction between a first end and a second end, where the first end of a selected horizontal strut 150 is disposed at a first outside corner 151a of a cell (right-most outside corner in the orientation shown in FIGS.2-3) and the second end of the selected horizontal strut 150 is disposed at a second outside corner 151b (left-most outside corner in the orientation shown in FIGS.2-3) of an adjacent cell in the same row.

[0166] The horizontal struts 150 can connect angled struts (for example, struts 130, 132, 134) of two adjacent rows of angled struts of the frame 102 to one another. For example, each horizontal strut 150 can connect to two angled struts of one row of struts (for example, struts 134 shown in FIG.3) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in FIG.3). As a result, an angled strut 134 extending between a commissure support 138 and a first horizontal strut 150, and an angled strut 132 extending between the first horizontal strut 150 and a second horizontal strut 150 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets 112 (when the leaflets 112 are coupled to the frame 102) and correspond to a leaflet stitch line 200, as will be described below. Thus, the horizontal struts 150 can allow the angled struts 130, 132, 133, 134 to follow a shape that more closely matches a shape of the scallop line of the leaflets 112 when the frame 102 is in the radially expanded working state (as shown in FIGS.1-2). Additionally, the horizontal struts 150 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby beneficially reducing a risk of pinching the leaflets 112 between the struts when the prosthetic heart valve 100 is in the radially compressed state.

[0167] In some examples, adjacent ones of angled struts 132 disposed below and connected to a horizontal strut 150 can define an angle 190 (which is also referred to herein as a “junction angle” and / or an “interior angle”). As shown, adjacent ones of angled struts 133 disposed above and connected to the same horizontal strut 150 define the same angle 190. Although the angled struts 130, 131, 132, 133, and 134 are presently shown to form the same angle 190, in some examples, the angled struts 130, 131, 132, 133, and 134 can each form a different angle.

[0168] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, where each one of the plurality of apex regions 152 forms a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 can be spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.

[0169] Each apex region 152 can comprise a corresponding apex 154 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding, wider, angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152 and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152. In some examples, each of the apex regions 152 can form an angle 180 between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152.

[0170] Referring back to FIG.1, the commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 as described above. In some examples, the commissures 114 of the prosthetic heart valve 100 can comprise two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through the commissure window 142 of the frame 102. Each commissure 114 can be secured to a respective commissure support 138 forming the commissure window 142.

[0171] The cusp edge portion (which is also referred to herein as a “scallop edge portion”) of each leaflet 112 can be coupled to the frame 102 via at least one suture forming a leaflet stitch line 200. In some examples, the cusp edge portion of each leaflet 112 can be secureddirectly to struts of the frame 102 (for example, angled struts 130, 132, 133, and 134) using a plurality of stitches 202 (FIG.5) that form the leaflet stitch line 200. The stitches 202 can extend through the cusp edge portion of each leaflet 112 and the inner skirt 107 and around selected angled struts that are adjacent the cusp edge portion. The positioning of the stitches 202 along the struts of the frame are represented by the regular dashed lines in FIGS.3-4. For example, the cusp edge portions of the leaflets 112 can be stitched to selected angled struts 130, 132, 133, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112. In some examples, the resulting leaflet stitch line 200 can form an undulating or zig-zag configuration circumferentially disposed around the frame 102 as shown in FIG.3 and described below. In some examples, each stitch 202 extends through the cusp edge portion of a leaflet and the inner skirt 107 and around an adjacent strut. In some examples, the stitches 202 extend through the inner skirt and around adjacent struts but do not penetrate the cusp edge portions of the leaflets 112; instead, the stitches 202 can extend around or through a reinforcing member (such as an Ethibond suture) that is secured to and extends along the cusp edge portions of the leaflets, as further described in WIPO Publication No. WO 2023 / 086548, which is incorporated herein by reference.

[0172] In the example shown in FIG.3, the leaflet stitch line 200 can be configured in identical segments extending circumferentially around the frame 102 in a continuous, repeating pattern. The leaflet stitch line 200 can comprise a first segment 210 having an outflow apex 214 disposed at an inflow end portion 139 of a commissure support 138. In the first segment 210, the leaflet stitch line 200 can extend from either side of the outflow apex 214 toward the inflow end 108 of the frame 102 along angled struts 134a and 134b, where the angled struts 134a, 134b are disposed immediately adjacent to the inflow end portion 139 of the corresponding commissure support 138.

[0173] In some examples, the leaflet stitch line 200 in the first segment 210 can further extend from the angled struts 134a and 134b, toward the inflow end 108 of the frame along angled struts 133a and 133b, where the angled struts 133a and 133b are disposed immediately adjacent to the angled struts 134a, 134b, respectively, along the angled lines described above and as shown in FIG.3.

[0174] In some examples, the leaflet stitch line 200 in the first segment 210 can further extend from the angled struts 133a and 133b, toward the inflow end 108 of the frame along angled struts 132a and 132b, where the angled struts 132a and 132b are disposed immediatelyadjacent to the angled struts 133a, 133b, respectively, along the angled lines described above and as shown in FIG.3.

[0175] In some examples, the leaflet stitch line 200 in the first segment 210 can be similarly extended from the angled struts 132a and 132b, toward the inflow end 108 of the frame along angled struts 130a and 130b, where the angled struts 130a and 130b are disposed immediately adjacent to the angled struts 132a, 132b, respectively, along the angled lines described above and as shown in FIG.3. The leaflet stitch line 200 at an inflow end of the angled strut 130a defines half of an inflow apex 216 while the leaflet stitch line 200 at an inflow end of the angled strut 130b defines half of an inflow apex 218.

[0176] The first segment 210 of the leaflet stitch line 200 can have a first, continuous line of stitches extending from the inflow apex 216 to the outflow apex 214, and a second, continuous line of stitches extending from the outflow apex 214 to the inflow apex 218, forming an inverted V shape with the vertex of the inverted V shape at the outflow apex 214.

[0177] The leaflet stitch line 200 can further comprise a second segment 230 disposed immediately, circumferentially adjacent to the first segment 210, where the second segment 230 with the first segment 210 together form the complete inflow apex 218 at the inflow end 108 of the frame 102. In the example shown in FIG.3, the second segment 230 has an identical configuration to the first segment 210. In other words, in the second segment 230, the leaflet stitch line 200 forms an inverted V shape identical to the inverted V shape of the first segment 210, where the vertex of the V shape at the outflow end is disposed at an outflow apex 234. The second segment 230 comprises a first, continuous line of stitches extending from the inflow apex 218 to the outflow apex 234, and a second, continuous line of stitches extending from the outflow apex 234 to an inflow apex 240. Like the outflow apex 214 of the first segment 210, the outflow apex 234 is located at an inflow end portion 139 of a commissure support 138.

[0178] Although FIG.3 shows of the frame 102 in a straightened and flattened (non-annular) state, it is understood that the frame has the annular configuration shown in FIG.2 and described above. As such, the leaflet stitch line 200 can further comprise a third segment 250 extending between and bridging the first and second segments 210, 230 around the annular frame 102 to form the circumferential leaflet stitch line 200.

[0179] The third segment 250 can extend from the second segment 230 at the inflow apex 240, forming the other half of the inflow apex 240. The third segment 250 can extend fromthe first segment 210 at the inflow apex 216, forming the other half of the inflow apex 216. In this manner, the leaflet stitch line 200 can extend continuously and circumferentially around the frame 102 and comprise the first, second, and third segments.

[0180] Similar to the first and second segments 210, 230, the leaflet stitch line can form an inverted V shape in the third segment 250, where the vertex of the V shape at the outflow end is disposed at an outflow apex 254. The third segment 250 can comprise a first, continuous line of stitches extending from the inflow apex 240 to the outflow apex 254, and a second, continuous line of stitches extending from the outflow apex 254 and the inflow apex 216. Like the outflow apices 214, 234 of the first and second segments 210, 230, the outflow apex 254 is located at an inflow end portion 139 of a commissure support 138. In this way, the leaflet stitch line 200 can assume a zig-zag configuration continuously and circumferentially disposed around the frame 102, generally corresponding to the cusp edge portions of the leaflets 112, where the outflow apices correspond to leaflet commissures.

[0181] In other examples, annular frames may comprise only three circumferentially extending rows of cells, namely the first row 120, the second row 126, and the third row 127 (i.e., the fourth row 128 can be omitted). In other examples, annular frames may comprise only two circumferentially extending rows of cells, namely the first row 120 and the second row 126, (i.e., the third row 127 and the fourth row 128 can be omitted). As such, the leaflet stitch line 200 can be adapted to have shorter continuous lines of stitches extending from outflow apices to inflow apices at the inflow end 108.

[0182] The plurality of stitches 202 can wrap around selected struts and over intervening horizontal struts 150 disposed between the selected struts to form the leaflet stitch line 200 described above. The plurality of stitches 202 can be, for example, whip stitches extending through the cusp edge portions of the leaflets 112 (or through or around a separate reinforcing member disposed on the cusp edge portions) and the inner skirt 107 to secure the leaflets 112 to the frame 102. At least one suture can form the plurality of stitches 202. In some examples, only one suture is used along the entire stitch line such that the stitches are continuous along the entire stitch line (each stitch extends from one stitch to another stitch except at the ends of the suture, which can be tied off to the frame). In some examples, a plurality of sutures can be used, such as a separate suture that is used to form stitches in each segment 210, 230, and 250. In some examples, more than one suture can be used to form stitches in each section. In some examples, one suture can form stitches in at least a portion of one of segments 210, 230, 250 and at least a portion of another segment.

[0183] The leaflet cusp edge portions are fixed to the frame 102 and, as a result, are stationary with respect to the frame 102. Conversely, portions of the leaflets 112 disposed downstream of the leaflet stitch line 200 can move and cycle between open and closed (i.e., coapting) configurations to regulate blood flow through the prosthetic valve. In other words, coapting edges of the leaflets 112 (i.e., opposite the stitched cusp edge portions) can alternate between the open configuration in which blood can flow through the valve, and the closed configuration in which blood flow through the valve is restricted. In the open configuration, movable portions of the leaflets 112 can be displaced in a radially outward direction, thus allowing blood flow therethrough.

[0184] In some examples, the outer surfaces 116 (which are the outflow surfaces in the illustrated example) of the movable portions of the leaflets 112 can contact facing portions of the frame 102 when deflected into the open configuration. The portions of the frame 102 that face the movable portions of the leaflets are denoted by a stippled area in FIG.3 and comprise regions of the frame 102 downstream of the leaflet stitch line 200.

[0185] As seen in FIG.3, in some examples, the inner skirt 107 can be secured to the frame 102 via at least one suture forming an inner skirt stitch line 300 (also referred to herein as a “skirt stitch line” or a “circumferential skirt stitch line”), which is separate from the leaflet stitch line 200. In some examples, the inner skirt 107 can have an annular shape and can be secured directly to selected struts of the frame 102 (for example, angled struts 130, 132, and 133) using a plurality of stitches 302 (FIGS.4-5) forming the skirt stitch line 300. The stitches 302 can extend through portions of the inner skirt 107 and around selected angled struts. The position of the stitches 302 along the struts are represented by the dot-dash-dot lines in FIG.3.

[0186] In some examples, the skirt stitch line 300 can form an undulating or zig-zag configuration circumferentially disposed around the frame 102 as shown in FIG.3. As will be described in more detail below, selected stitches 302 disposed within the stippled area of FIG.3 (i.e., downstream of the leaflet stitch line 200) can be advantageously configured to minimize abrasion of the leaflets 112 during valve cycling.

[0187] In the example shown in FIG.3, the skirt stitch line 300 can be configured in identical segments extending circumferentially around the frame 102 in a continuous, repeating pattern. The skirt stitch line 300 can comprise a first segment 310 having a first outflow apex 314 and a second outflow apex 315 disposed towards the outflow end 110 of the frame 102.The first and second outflow apices 314, 315 are disposed at selected first and second horizontal struts 150a, 150b, respectively, where the first horizontal strut 150a is immediately adjacent to the second horizontal strut 150b in the second row 126 of the frame 102. In other words, the first horizontal strut 150a extends horizontally from an outside corner 151b of a cell 118c and the second horizontal strut 150b extends horizontally from an outside corner 151a of the same cell 118c.

[0188] Additionally, the first and second horizontal struts 150a, 150b can be symmetrically disposed on either side of the inflow apex 216, as shown in FIG.3. That is, the first and second outflow apieces 314, 315 of the first segment 310 can be centered around the inflow apex 216 of the leaflet stitch line 200. Accordingly, the first and second outflow apieces 314, 315 of the first segment 310 can be centered between the outflow apices 214 and 254 of the leaflet stitch line 200. In this way, features of the skirt stitch line 300 can correspond to and be centered about features of the leaflet stitch line 200 circumferentially around the frame 102.

[0189] In the first segment 310, the skirt stitch line 300 can extend from either side of each first and second outflow apieces 314, 315 toward the inflow end 108 of the frame 102. More specifically, the skirt stitch line 300 can extend from the first outflow apex 314 along angled struts 133c and 133d, where the angled struts 133c, 133d are disposed immediately adjacent to the first horizontal strut 150a. Similarly, the skirt stitch line 300 can extend from the second outflow apex 315 along angled struts 133e and 133f, where the angled struts 133e, 133f are disposed immediately adjacent to second horizontal strut 150b.

[0190] The skirt stitch line 300 can extend over an intervening horizontal strut 150c to connect the portions of the skirt stitch line 300 disposed along the angled struts 133d and 133e.

[0191] In some examples, the skirt stitch line 300 in the first segment 310 can further extend from the angled struts 133c and 133f, toward the inflow end 108 of the frame along the angled struts 132c and 132d, where the angled struts 132c and 132d are disposed immediately adjacent to the angled struts 133c and 133f, respectively, as shown in FIG.3.

[0192] In some examples, the skirt stitch line 300 in the first segment 310 can further extend from the angled struts 132c and 132d, toward the inflow end 108 of the frame along the angled struts 130c and 130d, where the angled struts 130c and 130d are disposed immediately adjacent to the angled struts 132c and 132d, respectively, as shown in FIG.3.

[0193] The skirt stitch line 300 at an inflow end of the angled strut 130c defines half of an inflow apex 316 while the skirt stitch line 300 at an inflow end of the angled strut 130d defines half of an inflow apex 318.

[0194] In some examples, the first segment 310 of the skirt stitch line 300 has a first, continuous line of stitches extending from the inflow apex 316 to the first outflow apex 314, and a second, continuous line of stitches extending from the second outflow apex 315 and the inflow apex 318. The first segment 310 further comprises a first, shorter line of stitches extending from the first outflow apex 314 to the horizontal strut 150c along strut 133d and a second, shorter line of stitches extending from the horizontal strut 150c to the second outflow apex 315 along strut 133e. The first segment 310 of the skirt stitch line 300 thereby forms an M shape (or an inverted W shape) with the vertices of the M shape at the first and second outflow apices 314, 315.

[0195] The skirt stitch line 300 can further comprise a second segment 330 disposed immediately, circumferentially adjacent to the first segment 310, where the second segment 330 and the first segment 310 together form the complete inflow apex 318. In the example shown in FIG.3, the second segment 330 has an identical configuration to the first segment 310. In other words, in the second segment 330, the skirt stitch line 300 forms an M shape (or an inverted W shape) similar to the M shape of the first segment 310, where the vertices of the M shape at the outflow end are disposed at third and fourth outflow apices 334 and 335 corresponding to adjacent horizontal struts 150d and 150e, respectively. In some examples, the second segment 330 comprises a first, continuous line of stitches extending from the inflow apex 318 to the third outflow apex 334, and a second, continuous line of stitches extending from the fourth outflow apex 335 to an inflow apex 340. The second segment 330 further comprises a first, shorter line of stitches extending from the third outflow apex 334 to a horizontal strut 150f, and a second, shorter line of stitches extending from the horizontal strut 150f to the fourth outflow apex 335.

[0196] Due to the annular shape of the frame 102, the skirt stitch line 300 can further comprise a third segment 350 extending between and bridging the first and second segments 310, 330 around the annular frame 102 to form the circumferential skirt stitch line 300. The third segment 350 can extend from the second segment 330 at the inflow apex 340, forming the other half of the inflow apex 340. The third segment 350 can extend from the first segment 310 at the inflow apex 316, forming the other half of the inflow apex 316. In thismanner, the skirt stitch line 300 can extend circumferentially around the frame 102 and comprise the first, second, and third segments.

[0197] Similar to the first and second segments 310, 330, the skirt stitch line 300 can form an M shape (or an inverted W shape) in the third segment 350, where the vertices of the M shape at its outflow end are disposed at fifth and sixth outflow apices 354 and 355 corresponding to adjacent horizontal struts 150g and 150h, respectively. The third segment 350 can comprise a first, continuous line of stitches extending from the inflow apex 340 to the fifth outflow apex 354 and a second, continuous line of stitches extending from the sixth outflow apex 355 to the inflow apex 316. The third segment 350 can further comprise a first, shorter line of stitches extending from the fifth outflow apex 354 to a horizontal strut 150i, and a second, shorter line of stitches extending from the horizontal strut 150i to the sixth outflow apex 335.

[0198] In this way, the skirt stitch line 300 extending circumferentially along the first, second, and third segments can assume a zig-zag configuration circumferentially disposed around the frame 102.

[0199] As described above, in other examples, annular frames may comprise only three circumferentially extending rows of cells or only two circumferentially extending rows of cells. As such, the skirt stitch line 300 can be adapted to have shorter continuous lines of stitches extending from outflow apices to inflow apices at the inflow end 108.

[0200] To minimize abrasion on the moving portions of the leaflets 112 due to the stitches 302, selected stitches 302 disposed on portions of the frame 102 facing the movable portions of the leaflets can be configured to extend along the outer surface 109 of the frame 102 instead of along the inner surface 113 of the frame 102.

[0201] FIGS.4-5 are enlarged, detailed exterior views of portions of the frame 102 generally corresponding to the first segment 310, specifically, portions of the frame 102 facing the movable portions of the leaflets, according to an example. FIG.4 shows only the frame 102 with the skirt stitches 302 and the leaflet stitch line 200. FIG.5 shows the frame 102 with the inner skirt 107, the leaflet stitches 202, and the skirt stitches 302, where the plurality of stitches 302 are shown extending through the inner skirt 107 and around portions of the frame 102 to form the skirt stitch line 300.

[0202] At least one suture can form the plurality of stitches 302. In some examples, only one suture is used to form stitches that are continuous along the entire length of the skirt stitch line 300. In some examples, a plurality of sutures can be used, such as a separate suture thatis used to form continuous stitches in each segment 310, 330, and 350. In some examples, more than one suture can be used to form stitches in one or more segments 310, 330, and 350 (where more than one suture is used, there can be discontinuous stitches in those segments). In some examples, one suture can form continuous stitches in at least a portion of one of segment 310, 330, and 350 and at least a portion of another segment.

[0203] The plurality of stitches 302 can comprise a plurality of first stitches 360, for example whip stitches, that extend around selected angled struts (for example, any angled strut 117 disposed along the circumferential skirt stitch line 300) and a plurality of second stitches (also referred to herein as “horizontal stitches”) 370. As seen in FIG.4, the plurality of second stitches 370 extend along the outer surface 109 of the frame 102, specifically across horizontal struts 150 disposed along the skirt stitch line 300 in regions of the frame 102 downstream of the leaflet stitch line 200 and within the stippled area of FIGS.3-4.

[0204] For example, a plurality of first stitches 360 can be disposed around selected angled struts 132d, 133f, 133e, 133d, 133c, and 132c, forming a portion of the skirt stitch line 300 (stitches 360 additionally can be disposed on struts 130d and 130c). Each of the first stitches 360 can extend through the inner skirt 107, around a corresponding angled struts 132d, 133f, 133e, 133d, 133c, and 132c as shown in FIGS.4-5, or any other angled strut 117 disposed along the skirt stitch line 300) and back through the inner skirt 107, thereby securing the inner skirt 107 to the frame 102.

[0205] In some examples, at least one first stitch 360 extends around each angled strut of the selected angled struts disposed along the skirt stitch line 300. In some examples, at least two consecutive first stitches 360 extend around each angled strut of the selected angled struts. In some examples, exactly two consecutive first stitches 360 extend around each angled strut of the selected angled struts. In some examples, exactly three consecutive first stitches 360 extend around each angled strut of the selected angled struts along the skirt stitch line 300. The number of first stitches 360 extending around each angled strut of the selected angled struts can be specified to optimize manufacturing ease and retention of the inner skirt on the frame 102.

[0206] As noted above, the plurality of the second stitches 370 can be arranged to extend horizontally across the outer surface 109 of the frame 102, specifically within regions of the frame 102 downstream of the leaflet stitch line 200. For example, the second stitches 370 can extend over the horizontal struts 150a, 150b, and 150c in the first segment 310 of the skirtstitch line 300, where the horizontal struts 150a, 150b, and 150c face movable portions of the leaflets 112. Each of the second stitches 370 can extend from a first end of one of the horizontal struts 150a, 150b, and 150c to a second end of the same horizontal strut along only the outer surface 109. Each of the plurality of second stitches 370 can extend from one of the first stitches 360 on a first angled strut, through the inner skirt 107 to the outer surface 109 of the frame 102, across one of the horizontal struts 150a, 150b, and 150c (i.e. across junctions), and then back through the inner skirt 107 to another one of the first stitches 360 on another angled strut on the inner surface 113 of the frame 102. For example, in the region of horizontal strut 150c, a horizontal stitch 370 extends from a first stitch 360 on strut 133d, around the outside of the horizontal strut 150c, to another first stitch 360 which is on strut 133e. In some examples, a single second stitch 370 can extend over each of the horizontal struts 150a, 150b, 150c.

[0207] FIG.6 illustrates an inside view of the frame 102 and the inner skirt 107 of FIG.5, further showing the valve leaflets 112 in a closed configuration. As seen in FIG.6, because the second stitches 370 are disposed on an outside of the frame 102, the portion of the inner surface of the inner skirt 107 at the horizontal strut 150c is free of stitches. In this way, fewer stitches 302 protrude toward the leaflets 112 from the inside of the inner skirt 107. It has been found that horizontally disposed stitches 370 are more likely to cause leaflet abrasion than the stitches 360 on the angled struts. Thus, placing the stitches 370 on the outside of the frame can substantially reduce leaflet abrasion and improve the durability of the prosthetic valve.

[0208] Although only a portion of the skirt stitch line 300 and / or the leaflet stitch line 200 are shown in FIGS.4-6, it is understood that remaining portions of the skirt stitch line 300 and / or the leaflet stitch line 200 around the annular frame 102 are similarly arranged. By configuring the plurality of second stitches on the outer surface 109 of the frame 102, the likelihood of leaflet abrasion is reduced and durability of prosthetic valve is improved.

[0209] In some examples, the frame 102 is not formed with horizontal struts 150, in which case outside corners of adjacent cells in the same row are directly connected to each other. In such examples, the second stitches 370 extend on the outside of the junctions between two adjacent cells.

[0210] FIG.7 shows a delivery apparatus 400, according to an example, which can be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG.1and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 400 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0211] The delivery apparatus 400 in the illustrated example of FIG.7 is a balloon catheter comprising a handle 402 and a steerable, outer shaft 404 extending distally from the handle 402. The delivery apparatus 400 can further comprise an intermediate shaft 406 (which also may be referred to as a balloon shaft) that extends proximally from the handle 402 and distally from the handle 402, the portion extending distally from the handle 402 also extending coaxially through the outer shaft 404. Additionally, the delivery apparatus 400 can further comprise an inner shaft 408 extending distally from the handle 402 coaxially through the intermediate shaft 406 and the outer shaft 404 and proximally from the handle 402 coaxially through the intermediate shaft 406.

[0212] The outer shaft 404 and the intermediate shaft 406 can be configured to translate (e.g., move) longitudinally, along a central longitudinal axis 420 of the delivery apparatus 400, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0213] The intermediate shaft 406 can include a proximal end portion 410 that extends proximally from a proximal end of the handle 402, to an adaptor 412. A rotatable knob 414 can be mounted on the proximal end portion 410 and can be configured to rotate the intermediate shaft 406 around the central longitudinal axis 420 and relative to the outer shaft 404.

[0214] The adaptor 412 can include a first port 438 configured to receive a guidewire therethrough and a second port 440 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 440 can be fluidly coupled to an inner lumen of the intermediate shaft 406.

[0215] The intermediate shaft 406 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 404 when a distal end of the outer shaft 404 is positioned away from an inflatable balloon 418 of the delivery apparatus 400. A distal end portion of the inner shaft 408 can extend distally beyond the distal end portion of the intermediate shaft 406.

[0216] The balloon 418 can be coupled to the distal end portion of the intermediate shaft 406.

[0217] In some examples, a distal end of the balloon 418 can be coupled to a distal end of the delivery apparatus 400, such as to a nose cone 422 (as shown in FIG.7), or to an alternate component at the distal end of the delivery apparatus 400 (e.g., a distal shoulder). An intermediate portion of the balloon 418 can overlay a valve mounting portion 424 of a distal end portion of the delivery apparatus 400 and a distal end portion of the balloon 418 can overly a distal shoulder 426 of the delivery apparatus 400. The valve mounting portion 424 and the intermediate portion of the balloon 418 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG.7, a prosthetic heart valve 450 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 418, at the valve mounting portion 424 of the delivery apparatus 400.

[0218] The balloon shoulder assembly, including the distal shoulder 426, is configured to maintain the prosthetic heart valve 450 (or other medical device) at a fixed position on the balloon 418 during delivery through the patient’s vasculature.

[0219] The outer shaft 404 can include a distal tip portion 428 mounted on its distal end. The outer shaft 404 and the intermediate shaft 406 can be translated axially relative to one another to position the distal tip portion 428 adjacent to a proximal end of the valve mounting portion 424, when the prosthetic valve 450 is mounted in the radially compressed state on the valve mounting portion 424 (as shown in FIG.7) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 428 can be configured to resist movement of the prosthetic valve 450 relative to the balloon 418 proximally, in the axial direction, relative to the balloon 418, when the distal tip portion 428 is arranged adjacent to a proximal side of the valve mounting portion 424.

[0220] An annular space can be defined between an outer surface of the inner shaft 408 and an inner surface of the intermediate shaft 406 and can be configured to receive fluid from a fluid source via the second port 440 of the adaptor 412. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 408 and an inner surface of the balloon 418. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 418 and radially expand and deploy the prosthetic valve 450.

[0221] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 400 to the target implantation site.

[0222] The handle 402 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 400. In the illustrated example, for example, the handle 402 includes an adjustment member, such as the illustrated rotatable knob 460, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 402 through the outer shaft 404 and has a distal end portion affixed to the outer shaft 404 at or near the distal end of the outer shaft 404. Rotating the knob 460 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 400. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0223] The handle 402 can further include an adjustment mechanism 461 including an adjustment member, such as the illustrated rotatable knob 462, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 478. The adjustment mechanism 461 is configured to adjust the axial position of the intermediate shaft 406 relative to the outer shaft 404 (e.g., for fine positioning at the implantation site). Further details on the delivery apparatus 400 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0224] FIG.8 shows a prosthetic valve 500 comprising a radially expandable and / or compressible annular frame 502, a plurality of leaflets 504 mounted within the frame 502, and an outer skirt 506 secured to and around an outer surface of the frame 502. The frame 502 can comprise a plurality of interconnected angled struts 514. The angled struts 514 are arranged in a plurality of circumferentially extending rows of angled struts 514, with the rows being arrayed along an axial length of the frame 502 between an inflow end 516 and an outflow end 518 of the frame 502. A first circumferentially extending row of angled struts 514 at the outflow end 518 of the frame 502 is visible in FIG.8, and additional circumferentially extending rows of angled struts 514 of the frame 502 are described further below.

[0225] The outer skirt 506 (and / or any other skirts described herein) can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of variouspolymers), or combinations thereof. In some examples, the skirt can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirt can comprise a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirt can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirt can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirt can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0226] The frame 502 can comprise a plurality of apices 508 that are spaced circumferentially apart around the inflow end 516 and the outflow end 518 of the frame 502 (only the apices 508 at the outflow end 518 are visible in FIG.8). Each apex 508 is formed at a junction between two angled struts 514 at either the inflow end 516 or the outflow end 518.

[0227] The frame 502 comprises a plurality of axially extending posts (also referred to herein as “axial struts”) 510, some of which define commissure windows therein. For example, the axially extending posts 510 that define commissure windows therein can comprise axially extending window struts 520 (which can also be referred to herein as “commissure supports” or “commissure support posts”). The window struts 520 define a commissure window 522 therebetween. Commissure tabs 523 of adjacent leaflets 504 can be paired together and extend through the commissure windows 522, thereby forming commissures 512 secured to the frame 502 which can protrude radially outward from the frame 502. The commissure tabs 523 of adjacent leaflets 504 can be secured together to form commissures using attachment members (not labeled in FIG.8). In some examples, the prosthetic valve 500 can be a balloon expandable valve and can be used with a delivery apparatus, for example, the delivery apparatus 400 of FIG.7. Additional details on theprosthetic valve 500 can be found in PCT Publication No. WO / 2022 / 226147, which is incorporated by reference herein.

[0228] FIG.9 shows an example of a prosthetic heart valve 600 comprising a radially expandable and compressible annular frame 602 and a leaflet assembly 700 with a plurality of leaflets 702 secured to the frame. The frame 602 can be made of any of various suitable plastically-expandable materials (e g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). In some examples, the frame 602 comprises a plastically-expandable material, such as those described above for the prosthetic heart valves 100, 500 of FIGS.1 and 8, respectively.

[0229] The frame 602 can comprise a plurality of interconnected struts 606 which form multiple rows of open cells 608 between an outflow end 610 and an inflow end 612 of the frame 602. In some examples, as shown in FIG.9, the frame 602 can comprise three rows of cells 608 with a first (e.g., upper in FIG.9) row of cells 614, disposed at the outflow end 610, having cells 608 that are elongated in an axial direction (relative to a central longitudinal axis 616 of the frame 602), as compared to cells 608 in the remaining rows of cells. For example, the cells 608 of the first row of cells 614 can have a longer axial length, defined in a direction of a central longitudinal axis 616 of the frame 602, than cells 608 in the remaining rows of cells (e.g., cells in the row of cells at the inflow end 612).

[0230] In some examples, as shown in FIG.9, each row of cells 608 comprises nine cells. Thus, in such examples, the frame 602 can be referred to as a nine-cell frame. In some examples, the frame 602 can comprise more than three rows of cells (e.g., four or five) and / or more or less than nine cells per row. In some examples, the cells 608 in the first row of cells 614 may not be elongated compared to cells 608 in remaining rows of cells of the frame 602.

[0231] The interconnected struts 606 can include a plurality of angled struts 618, 634, 636, and 638 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the axial direction of the frame 602 between the outflow end 610 and the inflow end 612. For example, the frame 602 can comprise a first row of angled struts 638 arranged end-to-end and extending circumferentially at the inflow end 612 of the frame; a second row of circumferentially extending, angled struts 636; a third row of circumferentially extending, angled struts 634; and a fourth row of circumferentially extending, angled struts 618 at the outflow end 610 of the frame 602. The fourth row of angled struts 618 can be connected to the third row of angled struts 634 by a plurality ofaxially extending window strut portions 640 and a plurality of axial (e.g., axially extending) struts 632. The axially extending window strut portions 640 define commissure windows (e.g., open windows) 642 that are spaced apart from one another around the frame 602 in a circumferential direction. The window strut portions 640 forming the commissure windows 642 can also be referred to herein as commissure supports of the frame 602.

[0232] One or more (e.g., two, as shown in FIG.9) axial struts 632 can be positioned between, in the circumferential direction, two commissure windows 642 formed by the window strut portions 640. Since the frame 602 can include fewer cells per row (e.g., nine) and fewer axial struts 632 between each commissure window 642, as compared to other prosthetic heart valves, such as the prosthetic heart valve 100 of FIG.1, each cell 608 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0233] Each axial strut 632 and each window strut portion 640 extend from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 610) of two angled struts 618 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 610) of two angled struts 634 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 632 and each window strut portion 640 forms an axial side of two adjacent cells of the first row of cells 614.

[0234] Commissure tabs 706 of adjacent leaflets 702 can be secured together to form commissures 707. Each commissure 707 comprises two commissure tabs 706 paired together, one from each of two adjacent leaflets 702, and extending through a commissure window 642 of the frame 602. Each commissure 707 can be secured to the window strut portions 640 forming the commissure window 642.

[0235] As will be described in more detail below in connection with FIGS.10-17, the cusp edge portion (e.g., scallop edge) 708 of each leaflet 702 can be secured to the frame via one or more fasteners (e.g., sutures).

[0236] As shown in FIG.9, in some examples, one or more of or each of the axial struts 632 can comprise an inflow end portion 648 that is widened relative to a middle portion 647 of the axial strut 632 (which can be defined by a width 644) and an outflow end portion 646. In some examples, the inflow end portion 648 of the axial strut 632 can comprise an aperture649. The apertures 649 can be configured to receive fasteners (e.g., sutures) for attaching soft components of the prosthetic heart valve 600 to the frame 602. For example, in some examples, an outer skirt (such as an outer skirt similar to the outer skirts 106 and 506 of the prosthetic valves 100 and 500 as shown in FIGS.1 and 8, respectively, or any outer skirt described herein) can be positioned around an outer surface of the frame 602 and secured to the apertures 649.

[0237] The frame 602 can further comprise a plurality of apices 620 formed at the inflow end 612 and the outflow end 610, each apex 620 forming a junction between two angled struts 618 at the inflow end 612 or outflow end 610. As such, the apices 620 are spaced apart from one another, in a circumferential direction at the inflow end 612 and the outflow end 610.

[0238] As introduced above, a leaflet assembly of a prosthetic heart valve comprising a plurality of leaflets (for example, leaflets 702 shown in FIG.9) can either be secured to an inner skirt which is then secured to the struts of the frame of the prosthetic heart valve or directly to the struts of the frame (without the inner skirt). FIG.9 shows an example in which the leaflets 702 are directly secured to the struts 606 of the frame 602.

[0239] FIGS.10-12 illustrate the leaflets 702 secured together into the leaflet assembly 700 (or sub-assembly) with a connecting suture line 704 (also referred to herein as “connectors”) disposed along a cusp edge portion of each of the leaflets 702. As will be described further below, the connecting suture line 704 is configured to enable securing of the leaflet assembly 700 directly to a frame of a prosthetic heart valve (for example, any frame described herein, such as the frame 102 of FIGS.1-6, frame 502 of FIG.8, or frame 602 of FIG.9), without having to extend or thread sutures through the leaflet during assembly to the frame.

[0240] As used herein, a “connecting suture line” can be defined as a line of multiple sutures that extends along the cusp edge portion on at least one side of at least one leaflet and that comprises at least one first suture extending along the cusp edge portion on the at least one side of the at least one leaflet and a plurality of in-and-out stitches (e.g., formed with a second suture) that extend through the at least one first suture and the cusp edge portion of the leaflet. The in-and-out stitches can secure the first suture to the leaflet. The connecting suture line can be formed on the leaflet while the leaflet is off the frame. Further, the connecting suture line can be formed (e.g., stitched) manually or automatically.

[0241] Returning to FIGS.10-12, each leaflet 702 can comprise a cusp edge portion 708 extending between the opposing commissure tabs 706 (FIGS.10-12). FIG.12 shows a single leaflet 702 while FIGS.10 and 11 show a flat view and perspective view, respectively, of the leaflet assembly 700 comprising three leaflets 702 secured together along their cusp edge portions 708 by the connecting suture line 704.

[0242] To form the connecting suture line 704, one or more first sutures (referred to herein as a first thicker suture or a first main suture) 710 can be paced along the cusp edge portions 708, on a first side of the leaflets 702 (FIGS.10-12). In some examples, one or more second sutures (referred to herein as a second thicker suture or a second main suture) 712 can be placed along the cusp edge portions 708, on a second side of the leaflets 702, the second side arranged opposite the first side (FIG.12 and also shown in FIG.15B), such as disclosed in PCT Publication No. WO2023 / 086548, which is incorporated by reference herein.

[0243] To further form the connecting suture line 704 and connect the first thicker suture(s) 710 and / or the second thicker suture(s) 712 to the leaflets 702, a stitching suture (or third suture) 714 is stitched in a running-stitch pattern (e.g., an in-and-out pattern) through the first thicker suture 710 and / or the second thicker suture 712 and the leaflets 702 (e.g., through the thickness of the tissue of the leaflets 702) forming a plurality of in-and-out stitches 715, such as disclosed in PCT Publication No. WO2023 / 086548.

[0244] FIG.12 shows a view of one leaflet 702 with the thinner suture 714 being stitched in the running-stitch pattern through the first thicker suture 710, the cusp edge portion 708 of the leaflet 702, and the second thicker suture 712 (positioned behind the leaflet 702 in the view of FIG.12), thereby coupling the first thicker suture 710 and the second thicker suture 712 to the leaflet 702 and creating the connecting suture line 704.

[0245] In some examples, the commissure tabs 706 of the leaflets 702 can comprise one or more apertures 716 through the tissue of the commissure tabs 706 (FIGS.10 and 11). The apertures 716 can be configured to receive one or more fasteners (e.g., sutures) for fastening the commissure tabs to other components of the prosthetic heart valve (e.g., the frame, other commissure tabs, wedge members, or the like).

[0246] In some examples, another stitching suture (also referred to as another thinner suture) (which can be separate from or part of the thinner suture 714) can extend through the commissure tabs 706 (through the leaflet tissue or through apertures 716) to form a stitch line 718 (FIG.12). This stitch line 718 can be used to attach the commissure tabs 706 to othercomponents, such as a wedge or wedge member during attaching the leaflet assembly 700 to the frame of the prosthetic heart valve, as described further below.

[0247] Thus, the leaflet assembly 700, which includes the leaflets 702 (e.g., three leaflets) assembled together with the connecting suture line 704, can be formed off the frame of the prosthetic heart valve, in a flat configuration (as shown in FIG.10). By assembling the leaflet assembly 700 off the frame in a flat configuration, the leaflet assembly 700 can be formed more easily and quickly. For example, this can allow the connecting suture line 704 to be sewn automatically (e.g., with sewing machinery) across the flat leaflets 702. Advantageously, this can significantly reduce manufacturing time and costs.

[0248] After forming the leaflet assembly 700, the leaflet assembly 700 can be attached to an inner surface of a frame of a prosthetic heart valve (for example, any frame described herein, such as the frame 102 of FIGS.1-6, frame 502 of FIG.8, or frame 602 of FIG.9). The leaflets 702 are shown attached to the frame 602 in FIGS.13-15D, for example. Attachment of the leaflets 702 of the leaflet assembly 700 to the frame 602 can involve folding the cusp edge portions 708 of leaflets 702 such that an inner side 720 (which can be a rougher side of the tissue, and thus referred to as a rough side of the leaflets 702) of the cusp edge portions 708 of the leaflets 702 are facing the frame 602 (FIGS.15A and 15B).

[0249] An outer side 722 of the leaflets 702 (the side of the leaflets 702 opposite the inner side 720, which can be a smoother side of the leaflets) is shown in FIGS.12 and 13. FIG.13 shows a view of the frame 602 from the outflow end 610 and FIG.14 shows a view of the frame 602 from the inflow end 612. FIG.13 also shows pairs of commissure tabs 706 of the leaflets 702 extending radially through commissure windows of the frame 602 that are formed by commissure supports of the frame 602 (e.g., window strut portions 640 shown in FIG.9).

[0250] A connecting suture 724, such as a force fiber or UHMPE suture, can be looped around the struts 606 of the frame 602 and a portion of the connecting suture line 704 in order to attach the leaflet assembly 700 to the frame 602 without having to thread a needle and the connecting suture 724 through the tissue of the leaflets 702 (FIGS.14 and 15A), thereby avoiding puncturing the leaflets or sewing the suture 724 through to the leaflets while assembling the leaflets to the frame.

[0251] For example, in some instances, the connecting suture 724 can be looped around the struts 606 and through the portions of the connecting suture line 704 between the secondthicker suture 712 and the leaflets 702 (e.g., between the leaflets and the segments of the second thicker suture 712 that extend between the crossing points / stitches 715 formed by the thinner suture 714) (FIGS.14 and 15A-15D). In this manner, the connecting suture 724 forms a plurality of whip stitches 725, each of which extends around a frame strut 606 and around the suture 712 without extending through the leaflet (FIGS.15B and 15D). In some examples, one or more of the whip stitches 725 can extend around the suture 712 at locations underneath the stitches 715 instead of at locations between adjacent stitches 715. The connecting suture 724 can be used to secure the cusp edge portions 708 of the leaflets to the frame struts that generally track the curvature of the cusp edge portions. In particular, the connecting suture 724 can form whip stitches 725 along struts 634, 636, and 638 that generally track the curvature of the cusp edge portions 708.

[0252] In alternate examples, the connecting suture 724 can be routed through the second thicker suture 712, or between the stitches 715 and the second thicker suture 712.

[0253] In some examples, since the connecting suture 724 need not extend through any material, a blunt needle can be used for passing the connecting suture 724 through / around the connecting suture line 704.

[0254] The direct attachment of the leaflet assembly 700 to the frame 602, as shown in FIGS.13-15 can allow for the elimination of an inner skirt in the assembled prosthetic heart valve. The connecting suture line 704 allows for the direct attachment of the leaflet assembly 700 to the frame 602, without puncturing the tissue of the leaflets 702 during assembly of the leaflet assembly 700 to the frame 602. Further, by utilizing thicker sutures 710 and / or 712 that have a greater thickness that other sutures, such as the thinner suture 714, the thinner suture 714 can be prevented from tearing through a tissue of the leaflets 702, thereby creating a more robust connection between the leaflet assembly 700 and the frame 602.

[0255] The prosthetic heart valve can also comprise an outer skirt 726 that is disposed around and attached to an outer surface of the frame 602. In some examples, as shown in FIGS.16-17, the outer skirt 726 can be provided in the form of three separate skirt portions 732, each attached by passing a suture 728 through the fabric of the outer skirt 726, around a frame strut 606, and optionally through / around one of the thicker sutures 710 or 712 of the connecting suture line 704 of the leaflet assembly 700. For example, the suture 728 can form a plurality of whip stitches 729, each of which extends around a frame strut 606, through the skirt portion 732 and optionally around the suture 712 (e.g., each stitch 729 can extendbetween the suture 712 and a cusp edge portion 708). In some examples, the outer skirt 726 (or skirt portions 732) can include one or more preformed apertures 730 configured to receive the suture 728. FIG.16 shows an outer surface of the frame 602 and the outer skirt 726, showing one of the skirt portions 732 of the outer skirt 726 being attached to the frame 602. As shown in the perspective view of FIG.17, the suture 728 can secure the outer skirt 726 to the connecting suture line 704 on the leaflet 702 and to the frame 602 and the connecting suture 724 can secure the leaflets 702 to the struts 606 of the frame 602.

[0256] As introduced above, in some instances, when a frame is radially compressed, the frame can axially lengthen in relation to a central, longitudinal axis of the frame. As a result, in some instances, portions of an outer skirt attached to the frame can be pulled in the axial direction. It is desirable to configure these portions of the outer skirt with extra material such that, as the frame lengthens and the skirt is stretched, tension in the skirt is prevented or minimized.

[0257] FIGS.18-19 show a prosthetic heart valve 800, according to an example, comprising a radially expandable and compressible frame 802 and an outer skirt 806 secured to the frame 802. As will be described in more detail below, the skirt 806 is configured with slack portions in regions that are pulled axially as the frame 802 is axially lengthened. A valvular structure (such as, for example, the leaflet assembly 700 and leaflets 702 shown in FIGS.9- 17), can be mounted to an inside of the frame 802 as previously described above. The valvular structure is omitted for clarity in FIGS.18-19.

[0258] The frame 802 has an annular configuration with an axially disposed, central longitudinal axis 803, an inflow end 816, and an outflow end 818. Like the frames 102, 502 and 602 described above, the frame 802 can be made of any of various suitable plastically- expandable materials (e g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). The frame 802 can comprise a plurality of interconnected angled struts 814, including a plurality of angled struts 832, 833, 834, and 836 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the central longitudinal axis 803 of the frame 802 between the inflow end 816 and the outflow end 818. For example, the frame 802 can comprise a first row of circumferentially extending, angled struts 832 at the inflow end 816 of the frame 802; a second row of circumferentially extending, angled struts 833; a third row of circumferentially extending, angled struts 834; and a fourth row of circumferentially extending, angled struts 836 at the outflow end 818 of the frame 802.

[0259] The fourth row of angled struts 836 can be connected to the third row of angled struts 834 by a plurality of axial struts 810, each with an inflow end portion 811 and an outflow end portion 812, some of which define commissure windows 820. In some examples, the inflow end portion 811 of the axial strut 810 can comprise an aperture 813. The apertures 813 can be configured to receive fasteners (e.g., sutures) for attaching soft components to the frame 802, such as the outer skirt 806 which will be described further below.

[0260] In some examples, the axial struts 810 that define commissure windows 820 therein can comprise axially extending window struts 822 (which can also be referred to herein as “commissure supports” or “commissure support posts”). The window struts 822 have a space therebetween through which paired commissure tabs of adjacent leaflets forming commissures (such as, for example, commissures 707 of the leaflet assembly 700) can extend and secure to the frame 802. The commissure windows 820 have an inflow end portion 838 and an outflow end portion 839.

[0261] The frame 802 can comprise a plurality of apices 808 that are spaced circumferentially apart around the inflow end 816 and the outflow end 818 of the frame 802. Each apex 808 at the inflow end 816 is formed at a junction between two angled struts 832 and each apex 808 at the outflow end 818 is formed at a junction between two angled struts 836.

[0262] The outer skirt 806 can be disposed on an outer surface of the frame 802 and secured thereto via at least one suture forming a first outer skirt stitch line 840, in a similar manner as described above in connection with the suture 728 of the outer skirt 726 in FIGS.16-17. In some examples, the outer skirt 806 can have an annular shape with an outflow edge 850 and inflow edge 854, which will be described further below in connection to FIG.20.

[0263] The outer skirt 806 can be secured directly to selected angled struts 814 of the frame 802 with a plurality of stitches 842 that form the first outer skirt stitch line 840. In some examples, the stitches 842 can pass through the fabric of the outer skirt 806, around an adjacent frame strut 814, and optionally through / around a suture line on a cusp edge portion of the leaflet assembly, as described above regarding the stitches 729 in FIGS.16-17. In some examples, the outer skirt 806 can include one or more preformed apertures 897 configured to receive the suture forming the stitches 842.

[0264] In some examples, the first outer skirt stitch line 840 can form an undulating (e.g., scalloped or zig-zag pattern) configuration circumferentially disposed around the frame 802and comprising a plurality of alternating and circumferentially offset outflow apices 844 and inflow apices 846. The first outer skirt stitch line 840 can comprise a plurality of identical segments extending circumferentially around the frame 802 in a continuous, repeating pattern, such as a repeating inverted V-shape or U-shape. Each segment of the first outer skirt stitch line 840 can have an inverted V-shape with an outflow apex 844 at the inflow end portion 838 of a commissure window 820. An angled line of stitches 842 extends from each side of the outflow apex 844 toward adjacent inflow apices 846 of the first outer skirt stitch line 840. In the example shown in FIGS.18-19, the angled line of stitches comprises stitches 842 extending around adjacent angled struts 834, 833 and 832. Adjacent segments of the first outer skirt stitch line 840 meet at the inflow apices 846, thus forming the continuous, repeating zig-zag pattern circumferentially around the frame 802.

[0265] As seen in FIGS.18-19, the outflow edge 850 of the outer skirt 806 can be secured to the frame 802 with a plurality of stitches 862 forming a second outer skirt stitch line 860. The inflow edge 854 of the outer skirt can be secured to the frame 802 with a plurality of stitches 866 forming a third outer skirt stitch line 864. The stitches 862 can extend through an outflow edge portion of the outer skirt 806, around inflow end portions 811 of the axial struts 810, and back through the outflow edge portion of the outer skirt 806, thus securing the outflow edge 850 to the frame 802 at the axial struts 810. The stitches 862 can be configured as in-and-out stitches formed along the outflow edge portion of the outer skirt 806. In some examples, the stitches 862 forming the second outer skirt stitch line 860 can extend through an outflow edge portion of the outer skirt 806, through an aperture 813, and back through the outflow edge portion of the outer skirt 806, as shown in FIG.18.

[0266] Additionally, in some examples, the second outer skirt stitch line 860 can circumferentially traverse the outflow edge portion of the outer skirt 806 adjacent the outflow edge 850 and between adjacent outflow apices 844 of the first outer skirt stitch line 840, as shown in FIG.18, thus forming a continuous, annular stitch line at the outflow edge 850 of the skirt 806.

[0267] The stitches 866 forming the third outer skirt stitch line 864 can extend through an inflow edge portion of the outer skirt 806, around apices 808 at the inflow end 816 of the frame 802, and back through the inflow edge portion of the outer skirt 806, thus securing the inflow edge 854 to the frame 802, as shown in FIG.18. The stitches 866 can be configured as in-and-out stitches formed along the inflow edge portion of the outer skirt 806. In some examples, the third outer skirt stitch line 864 can circumferentially traverse the inflow edgeportion of the outer skirt 806 adjacent the inflow edge 854 and between adjacent apices 808 of the frame 802, thus forming a continuous, annular stitch line at the inflow end 816 of the frame 802. In this way, the outflow and inflow edges 850, 854 of the outer skirt 806 can be secured to adjacent portions of the frame 802.

[0268] Although the frame 802 is shown in FIGS.18-19 in a radially expanded state, the frame 802 can be crimped into a radially compressed state which can result in axial lengthening (i.e., an increase in an axial distance between the apices 808 at the inflow end 816 and the apices 808 at the outflow end 818) in a direction of the longitudinal axis 803, as described above. The outer skirt 806 can be configured with additional slack or loosened portions in select regions when the frame 802 is in a radially expanded state. In this way, when the outer skirt 806 is axially elongated during frame compression, this extra, loose material can be pulled from a slackened state to a pulled state with minimal or no added tension. In other words, slackened regions of the outer skirt can be moved into a pulled state, in some examples, when the frame is in a radially compressed configuration. The amount and location of the extra material can be arranged to reduce the likelihood of overstretching and / or over tensioning in the outer skirt 806.

[0269] In some examples, as seen in FIGS.18-19, first regions 870 of the outer skirt 806 between the outflow apices 844 of the first outer skirt stitch line 840 and the third outer skirt stitch line 864 can have extra slack. Similarly, second regions 872 of the outer skirt 806 between the inflow apices 846 of the first outer skirt stitch line 840 and the second outer skirt stitch line 860 can have extra slack. The extra material in the first and second regions 870, 872 can give the skirt 806 a puffy or puffed-out appearance when secured to the frame 802 in the radially expanded state as seen in FIGS.18-19.

[0270] To achieve extra slack in the first and second regions 870, 872, the skirt 806 can be configured with an undulating outflow edge 850 and an undulating inflow edge 854 as shown in FIG.20. The undulating outflow edge 850 defines a plurality of alternating extension portions 880a (also referred to herein as “slack portions”) and valley portions 882a (also referred to herein as “non-slack portions”), where the valley portions 882a are disposed between adjacent extension portions 880a and the extension portions 880a are generally adjacent axially to the second regions 872. The undulating inflow edge 854 defines a plurality of alternating extension portions 880b and valley portions 882b, where the valley portions 882b are disposed between adjacent extension portions 880b and the extension portions 880b are generally adjacent axially to the first regions 870. When the skirt 806 isassembled onto the frame, each extension portion 880a is positioned downstream of the connection of the cusp edges of the leaflets to the frame (e.g., the connecting suture line 704) and each extension portion 880b is upstream of the connection of the cusp edges of the leaflets to the frame. In some examples, the extension portions 880b can be aligned with the commissures along the length of the frame.

[0271] In some examples, the outer skirt 806 can have at least two extension portions 880a, 880b and at least two valley portions 882a, 882b.

[0272] In some examples, the edges 850, 854 of the outer skirt 806 can define exactly three extension portions 880a, 880b and exactly three valley portions 882a, 882b.

[0273] In some examples, the edges 850, 854 of the outer skirt 806 can define exactly four extension portions 880a, 880b and exactly four valley portions 882a, 882b.

[0274] In some examples, only the outflow edge 850 can define extension and valley portions 880a, 882a or only the inflow edge 854 can define extension and valley portions 880b, 882b.

[0275] Although the skirt 806 is shown in FIG.20 in a straightened and flattened (non- annular) state, it is understood that the skirt 806 has the annular configuration shown in FIGS. 18-19 and described above when secured to the frame 802, where a first end 884 extends directly into a second end 886. In this way, the alternating extension and valley portions 880a, 880b, 882a, 882b extend circumferentially around the annular frame 802 as shown in FIGS.18-19.

[0276] Referring back to FIG.20, the extension portions 880a are spaced apart from each other by a distance 887a along an x direction, where the x direction corresponds to a circumference of the frame 802 when the skirt 806 is in the annular configuration of FIGS. 18-19. Similarly, the extension portions 880b can be spaced apart from each other by a distance 887b along the x direction. In some examples, the distance 887a is the same as the distance 887b, as shown in FIG.20.

[0277] The extension portions 880a can be offset from the extension portions 880b along the x direction. In some examples, as shown in FIG.20, a midline or center 888 of each extension portion 880a can be aligned with a midline or center of an opposing valley portion 882b, as shown in FIG.20, where the midline 888 bisects the extension portion 880a in the x direction and, as shown in FIG.20, also bisects an opposing valley portion 882b.

[0278] In the example of FIG.20, each of the extension portions 880a can define an edge portion (also referred to herein as an “edge”) 890a of the outflow edge 850, where each edge portion 890a extends in the x direction a distance 892a. The edge portions 890a of each extension portion 880a can be aligned with other edge portions 890a in a y direction, where the y direction corresponds to an axial direction parallel to the central longitudinal axis 803 when the skirt 806 is in the annular configuration shown in FIGS.18-19. Similarly, each of the extension portions 880b can define an edge portion (also referred to herein as an “edge”) 890b of the inflow edge 854, where each edge portion 890b extends in the x direction a distance 892b. The edge portions of each extension portion 880b can be aligned with other edge portions 890b in the y direction.

[0279] Each of the valley portions 882a can define an edge portion (also referred to herein as an “edge”) 894a of the outflow edge 850, where each edge portion 894a extends in the x direction. The edge portions 894a of each valley portion 882a can be aligned with other edge portions 894a in the y direction. Similarly, each of the valley portions 882b can define an edge portion (also referred to herein as an “edge”) 894b of the inflow edge 854, where each edge portion 894b extends in the x direction. The edge portions 894b of each valley portion 882b can be aligned with other edge portions 894b in the y direction.

[0280] Accordingly, the edge portions 890a of the extension portions 880a can be offset a distance d1 from the edge portions 894a of the valley portions 882a in the y direction. The edge portions 890b of the extension portions 880b can be offset a distance d2 from the edge portions 894b of the valley portions 882b in the y direction. In some examples, d1 can be the same as d2. In some examples, d1 can be different than d2. In some examples, d1 and / or d2 can be, for example, 1-10 mm, 2-8 mm, 3-7 mm, or 3-5 mm. In some examples, d1 and / or d2 can be selected to be substantially equal (for example, within 5 percent) to the amount of axial lengthening of the frame 802 along the longitudinal axis 803 when radially compressed.

[0281] The undulating outflow edge 850 further comprises a plurality of angled edges 896a connecting adjacent extension and valley portions 880a, 882a and disposed at an angle a1 of 20-90 degrees, such as 45 degrees, from the x direction. The undulating inflow edge 854 similarly defines a plurality of angled edges 896b connecting adjacent extension and valley portions 880b, 882b and disposed at an angle a2 of 20-90 degrees, such as 45 degrees, from the x direction. In some examples, the angles a1 and a2 can be the same. In some examples, the angles a1 and a2 can be different. In some examples, the angles a1 and a2 can be selected to minimize the occurrence of abrupt (greater than or equal to 90 degree) corners between theadjacent extension and valley portions which can make stitching transitions between edge portions difficult and cumbersome.

[0282] The skirt 806 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof as described above regarding outer skirts 106 and 506. In some examples, when the outer skirt 806 is made of a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric, the yarns or fibers of the fabric can be disposed an angle of 20-70 degrees, such as 45 degrees, with respect to the y direction of the skirt 806. The angle of the yarns of the fabric can be selected to match and optimize stretching directionality of the skirt 806 when the skirt 806 is axially pulled during radial frame compression.

[0283] To secure the skirt 806 to the frame 802 as shown in FIGS.18-19 and described above, the skirt 806 is secured with stitches 842 that can be received within the preformed apertures 897 of a zig-zag shaped line 898, as shown in FIG.20, thus forming the first outer skirt stitch line 840 described above. In some examples, the apertures 897 can be arranged to form two parallel zig-zag shaped lines to facilitate the forming of whip stitches extending through the skirt.

[0284] The outflow edge portion of the skirt can be connected to the frame via the second outer skirt stitch line 860, as previously described. The outflow edge portion can have preformed apertures 895 to facilitate the formation of stitches 862. The inflow edge portion of the skirt can be connected to the frame via the third outer skirt stitch line 864, as previously described. The outflow edge portion can have preformed apertures 899 to facilitate the formation of stitches 866.

[0285] In some examples, areas of the skirt 806 along the first outer skirt stitch line 840 can be generally constrained to the frame 802 when stitched in place. In other words, the areas of the skirt along the first outer skirt stitch line 840 can move with the struts 814 around which the stitches 842 extend. The extension portions 880a are generally circumferentially aligned with the inflow apices 846 of the first outer skirt stitch line 840 and the extension portions 880b are generally circumferentially aligned with the outflow apices 844 of the first outer skirt stitch line 840.

[0286] The stitches 862 of the second outer skirt stitch line 860 can be disposed adjacent and substantially parallel to the undulating outflow edge 850 shown in FIG.20, generally alongside and parallel to the edges 890a, 894a, 896a of the extension and valley portions880a, 882a. The edges 890a of the extension portions 880a can be pushed closer to the edges 894a of the valley portions 882a to reduce the distance d1 when the skirt is assembled onto the frame 802 to form slack in the outer skirt downstream of the stitch line 840 (above the stitch line 840 in FIGS.18-19) in the second regions 872, which can billow radially outwardly from the outer surface of the frame. In some examples, the edges 890a of the extension portions 880a can be generally disposed at the same axial position around the circumference of the frame 802 as the edges 894a of the valley portions 882a (e.g., at the inflow end portions 811 of the axial struts 810 and / or commissure windows 820). In other words, the edges 890a can be generally aligned with the edges 894a in a circumferential direction such that they are spaced the same distance from the inflow end of the frame.

[0287] Similarly, stitches 866 of the third outer skirt stitch line 864 can be disposed adjacent and substantially parallel to the undulating inflow edge 854 shown in FIG. 20, generally alongside and parallel to the edges 890b, 894b, 896b of the extension and valley portions 880b, 882b. The edges 890b of the extension portions 880b can be pushed closer to the edges 894b of the valley portions 882b to reduce the distance d2 when the skirt is assembled onto the frame 802 to form slack in the outer skirt upstream of the stitch line 840 (below the stitch line 840 in FIGS.18-19) in the first regions 870, which can billow radially outwardly from the outer surface of the frame. In some examples, the edges 890b of the extension portions 880b can be disposed at the same axial position around the circumference of the frame 802 as the edges 894b of the valley portions 882b (e.g., at the inflow apices 808). In other words, the edges 890b can be generally aligned with the edges 894b in a circumferential direction such that they are spaced the same distance from the inflow end of the frame or alternatively, the edges 890b and the edges 894b are at the inflow end of the frame.

[0288] As described above, the distances d1, d2 can be selected to result in sufficient slack to accommodate axial lengthening of the frame 802 along the longitudinal axis 803. In this way, the outer skirt 806 can be pulled in an axial direction as the frame 802 lengthens along its longitudinal axis 803, thereby avoiding or minimizing tension in the skirt 806.

[0289] In some examples, the skirt 806 can be assembled onto the frame without reducing the distance d1, with the upper extension portions 880a further downstream than the valley portions 882a (and the edges 890a of the extension portions are closer to the outflow end of the frame than the edges 894a of the valley portions). In some such examples, the upper extension portions 880a can extend downstream of the upper ends of the first outer skirt stitch line 840 and the upper ends of the connecting suture line 704 (which connects to the cuspedges of the leaflets to the frame). In some such examples, the second regions 872 can lie flat against the outer surface of the frame without forming any slack in the skirt downstream of the stitch line 840. In some such examples, the first regions 870 can form slackened portions of the skirt 806 to accommodate axial lengthening of the frame when the frame is radially compressed.

[0290] In some examples, the skirt 806 can have a straight outflow edge (without any extension portions 880a and valley portions 882a), similar to the outflow edge of the outer skirt 106 (FIG.1), and the inflow edge includes the extension portions 880b and valley portions 882b. In some such examples, the first regions 870 of the skirt 806 can form slackened portions of the skirt to accommodate axial lengthening of the frame when the frame is radially compressed.

[0291] In the example shown in FIGS.18-19, as noted above, the leaflets of the prosthetic valve can be coupled to selected struts of the frame 802 using the stitching technique shown in FIGS.9-15D, and an inner skirt (e.g., inner skirt 107) can be optional. In some examples, the prosthetic valve 800 can include an inner skirt (e.g., inner skirt 107) and the leaflets can be stitched to the inner skirt (and optionally to struts of the frame). In some such examples, the outer skirt 806 optionally can be stitched to the inner skirt at one or more locations. For example, the stitches 862 of the second outer skirt stitch line 860 and / or the stitches 866 of the third outer skirt stitch line 864 can extend through the inner skirt. In some such examples, the stitch line 840 can be optional. Delivery Techniques

[0292] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and theapex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0293] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0294] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0295] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically ator near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0296] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art. Sterilization

[0297] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0298] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0299] Example 1. A prosthetic heart valve comprising: an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over junctions between the selected angled struts on an outer surface of the frame.

[0300] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein each of the second stitches extends horizontally from one of the first stitches to another one of the first stitches.

[0301] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein each of the plurality of second stitches extends from one of the first stitches through the inner skirt to the outer surface of the frame, across a junction, and then back through the inner skirt to another one of the first stitches on the inner surface of the frame.

[0302] Example 4. The prosthetic heart valve of any example herein, particularly any one of examples 1-3, wherein at least one first stitch extends around each angled strut of the selected angled struts.

[0303] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 1-4, wherein at least two consecutive first stitches extend around each angled strut of the selected angled struts.

[0304] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein exactly two consecutive first stitches extend around each angled strut of the selected angled struts.

[0305] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 1-6, wherein a single second stitch extends over each junction between the selected angled struts.

[0306] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the frame comprises a plurality of horizontal struts forming the junctions and connecting adjacent cells together, and wherein each of the plurality of second stitches extends over one of the horizontal struts on the outer surface of the frame.

[0307] Example 9. The prosthetic heart valve of any example herein, particularly any one of examples 1-8, wherein the rows of struts include a first row of struts and the plurality of first and second stitches form a skirt stitch line, wherein a first segment of the skirt stitch line comprises at least one first stitch on a first strut of the first row of struts, at least one first stitch on a second strut of the first row of struts, at least one first stitch on a third strut of the first row of struts, and at least one first stitch on a fourth strut of the first row of struts, wherein second stitches extend over a first junction between the first and second struts, a second junction between the second and third struts, a third junction between the third and fourth struts.

[0308] Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein the first, second, third, and fourth struts face an outer surface of movable portions of the leaflets.

[0309] Example 11. The prosthetic heart valve of any example herein, particularly any one of examples 9-10, wherein the rows of struts include a second row of struts upstream of the first row of struts, and wherein the first segment of the skirt stitch line comprises at least one first stitch on a fifth strut of the second row of struts and at least one first stitch of a sixth strut of the second row of struts, wherein the fifth strut is immediately adjacent the first strut and the sixth strut is immediately adjacent the fourth strut.

[0310] Example 12. The prosthetic heart valve of any example herein, particularly example 11, wherein the rows of struts include a third row of struts upstream of the second row of struts, wherein the first segment of the skirt stitch line comprises at least one first stitch on a seventh strut of the third row of struts and at least one first stitch on an eighth strut of the third row of struts, wherein the seventh strut is immediately adjacent the fifth strut and the eighth strut is immediately adjacent the sixth strut.

[0311] Example 13. The prosthetic heart valve of any example herein, particularly any one of examples 9-12, wherein the skirt stitch line comprises a repeating pattern of the first segment of the skirt stitch line around a circumference of the annular frame.

[0312] Example 14. The prosthetic heart valve of any example herein, particularly example 13, wherein the repeating pattern forms a continuous skirt stitch line circumferentially around the entire annular frame.

[0313] Example 15. The prosthetic heart valve of any example herein, particularly any one of examples 13-14, wherein the repeating pattern comprises at least three repeating first segments around the circumference of the annular frame.

[0314] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 13-15, wherein the repeating pattern comprises exactly three repeating first segments around the circumference of the annular frame.

[0315] Example 17. The prosthetic heart valve of any example herein, particularly any one of examples 13-16, wherein the repeating pattern forms a zig-zag pattern circumferentially around the annular frame.

[0316] Example 18. The prosthetic heart valve of any example herein, particularly any one of examples 1-17, wherein the plurality of leaflets are secured to the annular frame with stitches that extend around selected angled struts forming a leaflet stitch line.

[0317] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the leaflet stitch line forms an undulating pattern circumferentially around the annular frame.

[0318] Example 20. The prosthetic heart valve of any example herein, particularly any one of examples 18-19, wherein the annular frame comprises an inflow end and an outflow end, and the plurality of second stitches are arranged in a region of the annular frame between the leaflet stitch line and the outflow end.

[0319] Example 21. The prosthetic heart valve of any example herein, particularly any one of examples 9-17, wherein the first segment has an inverted W shape.

[0320] Example 22. A prosthetic heart valve comprising: an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein outside corners of adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a continuous stitch line comprising a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over respective junctions and between inside corners of adjacent cells in the same row, wherein the second stitches extend only on an outer surface of the frame at the junctions.

[0321] Example 23. The prosthetic heart valve of any example herein, particularly example 22, wherein the frame comprises a plurality of horizontal struts connecting outside corners of adjacent cells in the same row and the plurality of second stitches are disposed over outer surfaces of respective horizontal struts that face an outflow surface of movable portions of the leaflets.

[0322] Example 24. The prosthetic heart valve of any example herein, particularly any one of examples 22-23, wherein the rows of struts include a first row of struts, wherein a first segment of the continuous stitch line comprises at least one first stitch on a first strut of the first row of struts, at least one first stitch on a second strut of the first row of struts, at leastone first stitch on a third strut of the first row of struts, and at least one first stitch on a fourth strut of the first row of struts, wherein second stitches extend over a first junction between the first and second struts, a second junction between the second and third struts, and a third junction between the third and fourth struts.

[0323] Example 25. The prosthetic heart valve of any example herein, particularly example 24, wherein the first, second, third, and fourth struts face an outflow surface of one of the leaflets.

[0324] Example 26. The prosthetic heart valve of any example herein, particularly any one of examples 24-25, wherein the rows of struts includes a second row of struts upstream of the first row of struts, and wherein the first segment of the continuous stitch line comprises at least one first stitch on a fifth strut of the second row of struts and at least one first stitch of a sixth strut of the second row of struts, wherein the fifth strut is immediately adjacent the first strut and the sixth strut is immediately adjacent the fourth strut.

[0325] Example 27. The prosthetic heart valve of any example herein, particularly example 26, wherein the rows of struts includes a third row of struts upstream of the second row of struts, wherein the first segment of stitch line comprises at least one first stitch on a seventh strut of the third row of struts and at least one first stitch on an eighth strut of the third row of struts, wherein the seventh strut is immediately adjacent the fifth strut and the eighth strut is immediately adjacent the sixth strut.

[0326] Example 28. The prosthetic heart valve of any example herein, particularly any one of examples 22-27, wherein the continuous stitch line comprises a repeating pattern of the first segment around a circumference of the annular frame.

[0327] Example 29. The prosthetic heart valve of any example herein, particularly example 28, wherein the repeating pattern comprises at least three repeating first segments around the circumference of the annular frame.

[0328] Example 30. The prosthetic heart valve of any example herein, particularly example 29, wherein the repeating pattern comprises exactly three repeating first segments around the circumference of the annular frame.

[0329] Example 31. The prosthetic heart valve of any example herein, particularly any one of examples 28-30, wherein the repeating pattern forms a zig-zag pattern circumferentially around the annular frame.

[0330] Example 32. A prosthetic heart valve comprising: an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are separated from each other by horizontal struts; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inside of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected first angled struts and a plurality of second stitches, wherein each of the plurality of second stitches extends from a first end of a horizontal strut to a second end of the same horizontal strut only on an outer surface of the annular frame.

[0331] Example 33. The prosthetic heart valve of any example herein, particularly example 32, wherein the annular frame comprises at least three rows of circumferentially extending cells formed by the plurality of angled struts.

[0332] Example 34. The prosthetic heart valve of any example herein, particularly any one of examples 32-33, wherein the cells are diamond-shaped cells.

[0333] Example 35. The prosthetic heart valve of any example herein, particularly any one of examples 32-34, wherein the plurality of leaflets are secured to the annular frame with stitches that extends around selected second angled struts forming a leaflet stitch line.

[0334] Example 36. The prosthetic heart valve of any example herein, particularly example 35, wherein the leaflet stitch line forms an undulating pattern circumferentially around the annular frame.

[0335] Example 37. The prosthetic heart valve of any example herein, particularly any one of examples 32-36, wherein the annular frame comprises an inflow end and an outflow end, and the plurality of second stitches are arranged in a region of the annular frame between the leaflet stitch line and the outflow end.

[0336] Example 38. The prosthetic heart valve of any example herein, particularly any one of examples 32-36, wherein the plurality of second stitches are disposed on outer surfaces of horizontal struts facing an outflow surface of movable portions of the leaflets.

[0337] Example 39. The prosthetic heart valve of any example herein, particularly any one of examples 32-38, wherein the plurality of first and second stitches form a skirt stitch line comprising a first segment, a second segment, and a third segment extending circumferentially around the annular frame.

[0338] Example 40. The prosthetic heart valve of any example herein, particularly example 39, wherein the second segment is disposed immediately adjacent the first segment on a first side of the first segment and the third segment is disposed immediately adjacent the first segment on a second side of the first segment which is opposite the first side.

[0339] Example 41. The prosthetic heart valve of any example herein, particularly any one of examples 39-40, wherein the first segment shares a first inflow apex with the second segment and the first segment shares a second inflow apex with the third segment.

[0340] Example 42. The prosthetic heart valve of any example herein, particularly any one of examples 39-41, wherein the second and third segments share a third inflow apex.

[0341] Example 43. The prosthetic heart valve of any example herein, particularly any one of examples 39-42, wherein the first, second, and third segments are identical to each other.

[0342] Example 44. The prosthetic heart valve of any example herein, particularly any one of examples 39-43, wherein the skirt stitch line forms a zig-zag pattern circumferentially around the annular frame.

[0343] Example 45. A method of securing an inner skirt to an annular frame of a prosthetic heart valve, the method comprising: arranging the inner skirt on an inner surface of the annular frame, wherein the annular frame comprises a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; and securing the inner skirt to the annular frame using at least one suture forming a first stitch line, wherein the first stitch line comprises a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over adjacent junctions only on an outer surface of the frame.

[0344] Example 46. The method of any example herein, particularly example 45, wherein a plurality of leaflets of the prosthetic heart valve are secured to the inner surface of the annular frame along a second stitch line.

[0345] Example 47. The method of any example herein, particularly example 46, further comprising forming the second stitch line using a plurality of whip stitches extending around adjacent angled struts.

[0346] Example 48. The method of any example herein, particularly any one of examples 46-47, further comprising forming the second stitch line in an undulating pattern circumferentially around the annular frame.

[0347] Example 49. The method of any example herein, particularly any one of examples 46-48, wherein the annular frame comprises an inflow end and an outflow end, and the method further comprises forming the plurality of second stitches over junctions in a region of the annular frame between the second stitch line and the outflow end.

[0348] Example 50. The method of any example herein, particularly any one of examples 46-48, further comprising forming the plurality of second stitches on outer surfaces of junctions facing an outflow surface of movable portions of the leaflets.

[0349] Example 51. The method of any example herein, particularly any one of examples 45-50, further comprising forming the plurality of second stitches by extending the at least one suture from one of the first stitches through the inner skirt to the outer surface of the frame, across a junction, and then back through the inner skirt to another one of the first stitches on the inner surface of the frame.

[0350] Example 52. The method of any example herein, particularly any one of examples 45-51, further comprising whip stitching the plurality of first stitches through the inner skirt and around adjacent angled struts.

[0351] Example 53. The method of any example herein, particularly any one of examples 45-52, further comprising forming the first stitch line in a zig-zag pattern circumferentially around the annular frame.

[0352] Example 54. A prosthetic valve comprising: a radially expandable and compressible, annular frame comprising in inflow end, an outflow end, and a plurality of rows of angled struts disposed between the inflow and outflow ends; a valvular structure comprising a plurality of leaflets disposed within the frame; and an outer skirt disposed on an outer surface of the frame, the outer skirt comprising an inflow edge and an outflow edge, wherein the outer skirt is secured to the frame along a first outer skirt stitch line with first stitches that extend around selected angled struts, wherein the first outer skirt stitch line forms a repeating undulating pattern around a circumference of the outer skirt, and wherein first regions of the outer skirt upstream of the first outer skirt stitch line form slackened portions of the outer skirt when the frame is in a radially expanded state.

[0353] Example 55. The prosthetic valve of any example herein, particularly example 54, wherein second regions of the outer skirt downstream of the first outer skirt stitch line form slackened portions of the outer skirt when the frame is in a radially expanded state.

[0354] Example 56. The prosthetic valve of any example herein, particularly any one of examples 54-55, wherein each leaflet has a cusp edge portion coupled to the annular frame with second stitches along a leaflet stitch line, wherein the second stitches extend around the selected angled struts on which the first stitches are secured.

[0355] Example 57. The prosthetic valve of any example herein, particularly any one of examples 54-56, wherein the first outer skirt stitch line forms a repeating V-shaped or U- shaped pattern.

[0356] Example 58. The prosthetic valve of any example herein, particularly any one of examples 54-56, wherein the first outer skirt stitch line comprises a plurality of inflow apices and a plurality of outflow apices that are circumferentially offset from the inflow apices.

[0357] Example 59. The prosthetic valve of any example herein, particularly example 58, when dependent on example 55, wherein the second regions of the outer skirt are circumferentially aligned with the inflow apices of the first outer skirt stitch line.

[0358] Example 60. The prosthetic valve of any example herein, particularly any one of examples 58-59, wherein the first regions of the outer skirt are circumferentially aligned with the outflow apices of the first outer skirt stitch line.

[0359] Example 61. The prosthetic valve of any example herein, particularly any one of examples 54-60, wherein the annular frame comprises a plurality of axial struts extending from a row of angled struts at the outflow end of the frame toward the inflow end of the frame, and wherein the outflow edge of the outer skirt is secured to the axial struts with a plurality of third stitches.

[0360] Example 62. The prosthetic valve of any example herein, particularly example 61, wherein the plurality of third stitches form a second outer skirt stitch line that extends circumferentially around the frame.

[0361] Example 63. The prosthetic valve of any example herein, particularly any one of examples 54-62, wherein the inflow edge of the outer skirt is secured to the frame with a plurality of fourth stitches that extend around apices at the inflow end of the frame.

[0362] Example 64. The prosthetic valve of any example herein, particularly example 63, wherein the plurality of fourth stitches form a third outer skirt stitch line that extends circumferentially around the annular frame.

[0363] Example 65. The prosthetic valve of any example herein, particularly any one of examples 54-64, wherein first regions of the outer skirt are in a pulled state when the annular frame is in a radially compressed configuration.

[0364] Example 66. The prosthetic valve of any example herein, particularly any one of examples 54-65, wherein the inflow edge of the outer skirt defines a plurality of extension portions spaced apart from each other by a plurality of valley portions.

[0365] Example 67. The prosthetic valve of any example herein, particularly any one of examples 54-66, wherein the outflow edge of the outer skirt defines a plurality of extension portions spaced apart from each other by a plurality of valley portions.

[0366] Example 68. The prosthetic valve of any example herein, particularly example 67, when dependent on example 66, wherein the extension portions of the inflow edge are offset from the extension portions of the outflow edge in a circumferential direction.

[0367] Example 69. The prosthetic valve of any example herein, particularly example 68, wherein the number of extension portions of each of the inflow edge and the outflow edge equals the number of leaflets.

[0368] Example 70. A skirt for a prosthetic valve, the skirt comprising: an outflow edge extending along a first direction; and an undulating inflow edge extending along the first direction and disposed a first distance from the outflow edge in a second direction perpendicular to the first direction, wherein the undulating inflow edge defines a plurality of spaced apart extension portions and valley portions.

[0369] Example 71. The skirt of any example herein, particularly example 70, wherein the outflow edge is undulating along the first direction and defines a plurality of spaced apart extension portions and valley portions.

[0370] Example 72. The skirt of any example herein, particularly example 71, wherein the extension portions of the outflow edge are offset from the extension portions of the inflow edge in the first direction.

[0371] Example 73. The skirt of any example herein, particularly example 72, wherein a midline bisecting each extension portion of the outflow edge is aligned with a midline bisecting an opposing valley portion of an inflow edge in the first direction.

[0372] Example 74. The skirt of any example herein, particularly any one of examples 70- 73, wherein the inflow edge defines at least three extension portions and at least three valley portions.

[0373] Example 75. The skirt of any example herein, particularly example 74, wherein the inflow edge defines exactly three or four extension and valley portions.

[0374] Example 76. The skirt of any example herein, particularly any one of examples 71- 74, wherein the outflow edge defines at least three extension portions and at least three valley portions.

[0375] Example 77. The skirt of any example herein, particularly any one of examples 71- 75, wherein the outflow edge defines exactly three or four extension and valley portions.

[0376] Example 78. The skirt of any example herein, particularly any one of examples 70- 77, wherein the valley portions of the inflow edge comprise first edge portions that are aligned with each other in the second direction and the extension portions of the inflow edge comprise second edge portions that are aligned with each other in the second direction.

[0377] Example 79. The skirt of any example herein, particularly example 78, wherein the first edge portions and second edge portions are spaced apart by a second distance in the y direction.

[0378] Example 80. The skirt of any example herein, particularly any one of examples 71- 78, wherein the valley portions of the outflow edge comprise third edge portions that are aligned with each other in the second direction and the extension portions of the outflow edge comprise fourth edge portions that are aligned with each other in the second direction.

[0379] Example 81. The skirt of any example herein, particularly example 80, wherein the third edge portions and fourth edge portions are spaced apart by a third distance in the y direction.

[0380] Example 82. The skirt of any example herein, particularly any one of examples 70- 81, wherein the inflow edge further defines a plurality of inflow angled portions connecting adjacent extension portions and valley portions.

[0381] Example 83. The skirt of any example herein, particularly example 82, wherein the plurality of inflow angled portions are disposed at an angle of 20 to 70 degrees with respect to the first direction.

[0382] Example 84. The skirt of any example herein, particularly any one of examples 71- 82, wherein the outflow edge further defines a plurality of outflow angled portions disposed between adjacent extension portions and valley portions.

[0383] Example 85. The skirt of any example herein, particularly example 84, wherein the plurality of outflow angled portions are disposed at an angle of 20 to 70 degrees with respect to the first direction.

[0384] Example 86. The skirt of any example herein, particularly any one of examples 70- 85, wherein the skirt is made of a fabric comprising yarns or fibers disposed at an angle greater than zero with respect to the first direction.

[0385] Example 87. The skirt of any example herein, particularly example 86, wherein the angle is in a range of 20-70 degrees.

[0386] Example 88. The skirt of any example herein, particularly any one of examples 70- 87, in combination with a radially compressible and expandable annular frame, wherein the skirt is secured to an outer surface of the frame, and wherein the first direction corresponds to a circumference of the frame and the second direction corresponds to a longitudinal axis of the frame when the skirt is secured to the frame.

[0387] Example 89. A method of assembling a prosthetic heart valve comprising a frame and an outer skirt, the method comprising: stitching an outer skirt to the frame, wherein the outer skirt has an inflow edge defining a plurality of extension portions spaced from each other by valley portions in a circumferential direction; and after stitching the outer skirt to the frame, the plurality of extension portions form slack portions in the outer skirt in regions adjacent the extension portions.

[0388] Example 90. The method of any example herein, particularly example 89, wherein the slack portions are in a loose state when the frame is in a radially expanded configuration and a pulled state when the frame is in a radially compressed configuration.

[0389] Example 91. The method of any example herein, particularly any one of examples 89-90, wherein the act of stitching the outer skirt to the frame comprises stitching along anouter skirt stitch line forming an undulating pattern extending circumferentially around the frame.

[0390] Example 92. The method of any example herein, particularly any one of examples 89-91, wherein the act of stitching the outer skirt to the frame comprises stitching the plurality of extension portions of the inflow edge of the outer skirt around apices at an inflow end of the frame.

[0391] Example 93. The method of any example herein, particularly any one of examples 89-92, wherein the outer skirt has an outflow edge defining a plurality of extension portions spaced from each other by valley portions in the circumferential direction.

[0392] Example 94. The method of any example herein, particularly example 93, wherein the extension portions of the outflow edge are stitched to axial struts of the frame.

[0393] Example 95. The method of any example herein, particularly any one of examples 89-94, further comprising securing a valvular structure comprising a plurality of leaflets to the frame, wherein each leaflet has a cusp edge portion that is secured to the frame with stitches.

[0394] Example 96. A prosthetic valve comprising: a radially expandable and compressible, annular frame comprising an inflow end, an outflow end, and a plurality of rows of angled struts disposed between the inflow and outflow ends; a valvular structure comprising a plurality of leaflets disposed within the frame; and an outer skirt disposed on an outer surface of the frame, the outer skirt comprising an inflow edge and an outflow edge, wherein the inflow edge comprises a plurality of extension portions spaced apart from each other in a circumferential direction by a plurality of valley portions.

[0395] Example 97. The prosthetic valve of any example herein, particularly example 96, wherein the outflow edge of the outer skirt comprises a plurality of extension portions spaced apart from each other in the circumferential direction by a plurality of valley portions.

[0396] Example 98. The prosthetic valve of any example herein, particularly example 97, wherein the extension portions of the inflow edge are offset from the extension portions of the outflow edge in the circumferential direction.

[0397] Example 99. The prosthetic valve of any example herein, particularly any one of examples 96-98, wherein the outer skirt forms slackened regions adjacent the extension portions of the inflow edge when the frame is in a radially expanded state.

[0398] Example 100. The prosthetic valve of any example herein, particularly example 99, wherein the outer skirt is secured to the frame along a first outer skirt stitch line with first stitches that extend around selected angled struts, wherein the first outer skirt stitch line forms a repeating undulating pattern around a circumference of the outer skirt, wherein the slackened regions are upstream of the first outer skirt stitch line.

[0399] Example 101. The prosthetic valve of any example herein, particularly any one of examples 97-98, wherein the outer skirt forms slackened regions adjacent the extension portions of the outflow edge when the frame is in a radially expanded state.

[0400] Example 102. The prosthetic valve of any example herein, particularly example 101, wherein the outer skirt is secured to the frame along a first outer skirt stitch line with first stitches that extend around selected angled struts, wherein the first outer skirt stitch line forms a repeating undulating pattern around a circumference of the outer skirt, wherein the slackened regions are downstream of the first outer skirt stitch line.

[0401] Example 103. The prosthetic valve of any example herein, particularly example 102, wherein the outer skirt forms slackened regions adjacent the extension portions of the inflow edge and upstream of the first outer skirt stitch line when the frame is in a radially expanded state.

[0402] Example 104. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0403] Example 105. A prosthetic heart valve of any one of examples 1-104, wherein the prosthetic heart valve is sterilized.

[0404] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one stitch line or method of stitching can be combined with any one or more features of another stitch line or method of stitching. As another example, any one or more features of one outer skirt can be combined with any one or more features of another outer skirt.

[0405] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

CLAIMS:

1. A prosthetic heart valve comprising: an annular frame comprising a plurality of angled struts arranged in a plurality of circumferentially extending rows of struts forming a plurality of circumferentially extending rows of cells, wherein adjacent cells in the same row are connected to each other at junctions; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction; and an inner skirt disposed on an inner surface of the frame, wherein the inner skirt is connected to the frame with at least one suture forming a plurality of first stitches that extend around selected angled struts and a plurality of second stitches that extend over junctions between the selected angled struts on an outer surface of the frame.

2. The prosthetic heart valve of claim 1, wherein each of the second stitches extends horizontally from one of the first stitches to another one of the first stitches.

3. The prosthetic heart valve of any one of claims 1-2, wherein at least one first stitch extends around each angled strut of the selected angled struts.

4. The prosthetic heart valve of any one of claims 1-3, wherein the rows of struts include a first row of struts and the plurality of first and second stitches form a skirt stitch line, wherein a first segment of the skirt stitch line comprises at least one first stitch on a first strut of the first row of struts, at least one first stitch on a second strut of the first row of struts, at least one first stitch on a third strut of the first row of struts, and at least one first stitch on a fourth strut of the first row of struts, wherein second stitches extend over a first junction between the first and second struts, a second junction between the second and third struts, a third junction between the third and fourth struts.

5. The prosthetic heart valve of claim 4, wherein the first, second, third, and fourth struts face an outer surface of movable portions of the leaflets.

6. The prosthetic heart valve of any one of claims 4-5, wherein the skirt stitch line comprises a repeating pattern of the first segment of the skirt stitch line around a circumference of the annular frame.

7. The prosthetic heart valve of any one of claims 1-6, wherein the plurality of leaflets are secured to the annular frame with stitches that extend around selected angled struts forming a leaflet stitch line.

8. The prosthetic heart valve of claim 7, wherein the leaflet stitch line forms an undulating pattern circumferentially around the annular frame.

9. The prosthetic heart valve of any one of claims 7-8, wherein the annular frame comprises an inflow end and an outflow end, and the plurality of second stitches are arranged in a region of the annular frame between the leaflet stitch line and the outflow end.

10. A prosthetic valve comprising: a radially expandable and compressible, annular frame comprising in inflow end, an outflow end, and a plurality of rows of angled struts disposed between the inflow and outflow ends; a valvular structure comprising a plurality of leaflets disposed within the frame; and an outer skirt disposed on an outer surface of the frame, the outer skirt comprising an inflow edge and an outflow edge, wherein the outer skirt is secured to the frame along a first outer skirt stitch line with first stitches that extend around selected angled struts, wherein the first outer skirt stitch line forms a repeating undulating pattern around a circumference of the outer skirt, and wherein first regions of the outer skirt upstream of the first outer skirt stitch line form slackened portions of the outer skirt when the frame is in a radially expanded state.

11. The prosthetic valve of claim 10, wherein second regions of the outer skirt downstream of the first outer skirt stitch line form slackened portions of the outer skirt when the frame is in a radially expanded state.

12. The prosthetic valve of any of claims 10-11, wherein the first outer skirt stitch line comprises a plurality of inflow apices and a plurality of outflow apices that are circumferentially offset from the inflow apices.

13. The prosthetic valve of claim 12, when dependent on claim 11, wherein the second regions of the outer skirt are circumferentially aligned with the inflow apices of the first outer skirt stitch line.

14. The prosthetic valve of any one of claims 12-13, wherein the first regions of the outer skirt are circumferentially aligned with the outflow apices of the first outer skirt stitch line.

15. The prosthetic valve of any of claims 10-14, wherein first regions of the outer skirt are in a pulled state when the annular frame is in a radially compressed configuration.

16. The prosthetic valve of any of claims 10-15, wherein the inflow edge of the outer skirt defines a plurality of extension portions spaced apart from each other by a plurality of valley portions.

17. The prosthetic valve of any of claims 10-16, wherein the outflow edge of the outer skirt defines a plurality of extension portions spaced apart from each other by a plurality of valley portions.

18. A method of assembling a prosthetic heart valve comprising a frame and an outer skirt, the method comprising: stitching an outer skirt to the frame, wherein the outer skirt has an inflow edge defining a plurality of extension portions spaced from each other by valley portions in a circumferential direction; and after stitching the outer skirt to the frame, the plurality of extension portions form slack portions in the outer skirt in regions adjacent the extension portions.

19. The method of claim 18, wherein the slack portions are in a loose state when the frame is in a radially expanded configuration and a pulled state when the frame is in a radially compressed configuration.

20. The method of any one of claims 18-19, wherein the act of stitching the outer skirt to the frame comprises stitching the plurality of extension portions of the inflow edge of the outer skirt around apices at an inflow end of the frame.

Images