Attachment of leaflets and skirt to prosthetic valve frame

Abstract

The present invention relates to implantable prosthetic devices, such as prosthetic heart valves, and to attachment configurations and methods for attaching flexible components, such as valve leaflets or skirts, to the frames of such prosthetic valves.

Description

[Technical Field]

[0001] The present invention relates to implantable prosthetic devices (such as prosthetic heart valves) and to attachment configurations and methods for attaching soft components (such as leaflets or skirts) to the frames of such prosthetic valves. [Background technology]

[0002] Natural heart valves (such as the aortic, pulmonary, and mitral valves) function to ensure proper directional flow from (and to) the heart and between the heart's chambers, supplying blood throughout the cardiovascular system. Various valvular diseases can disable the valves and require their replacement with artificial valves. Surgical procedures can be performed to repair or replace heart valves. Because surgery is prone to numerous clinical complications, less invasive alternative techniques have been developed over the years in which artificial heart valves are delivered over a catheter and implanted over the native, dysfunctional valve.

[0003] Different types of prosthetic heart valves are currently known, including balloon-expandable valves, self-expandable valves, and mechanically expandable valves. Different methods of delivery and implantation are also known, which can vary depending on the site of implantation and the type of prosthetic valve. One exemplary technique involves utilizing a delivery assembly to deliver the prosthetic valve in a crimped configuration from an incision, which may be located in the patient's femoral or iliac artery, toward the native, dysfunctional valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it may be expanded against the surrounding anatomical structures (e.g., the annulus of the native valve), and the delivery assembly may then be retrieved.

[0004] One of the complications that can be associated with implanted prosthetic heart valves is thrombus formation on the prosthetic structure, which can result in reduced leaflet mobility or impaired coaptation, reduced valve orifice effective area, increased transvalvular pressure gradients, or transvalvular regurgitation. Thrombus can form due to tissue ingrowth in fabric components of the prosthetic valve (e.g., fabrics utilized as intermediates for connecting the leaflets of a prosthetic valve to its frame). Therefore, a need exists for methods and configurations for connecting the leaflets to the frame that minimize or eliminate the need for incorporation of fabric components, thereby reducing the risk of tissue ingrowth and thrombus formation. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 7,993,394 [Patent Document 2] U.S. Patent No. 9,393,110 [Patent Document 3] U.S. Patent No. 9,155,619 [Patent Document 4] U.S. Patent No. 6,730,118 [Patent Document 5] U.S. Patent No. 6,767,362 [Patent Document 6] U.S. Patent No. 6,908,481 [Patent Document 7] U.S. Patent No. 9,827,093 [Patent Document 8] US Patent Application Publication No. 2019 / 0060057 [Patent Document 9] US Patent Application Publication No. 2018 / 0153689 [Patent Document 10] US Patent Application Publication No. 2018 / 0344456 [Patent Document 11] U.S. Patent No. 7,393,360 [Patent Document 12] U.S. Patent No. 7,510,575 [Patent Document 13] U.S. Patent No. 8,252,202 [Patent Document 14] US Patent Publication No. 2018 / 0325665 [Patent Document 15] US Patent Publication No. 2019 / 0105153 Summary of the Invention [Means for solving the problem]

[0006] The present disclosure relates to a prosthetic heart valve including an expandable frame and leaflet assembly, the leaflets connected to struts of the frame via primary sutures that are passed in an in-and-out pattern along cusp end portions of the leaflets, and secondary sutures that are passed through the primary sutures and around the struts, the secondary sutures having a plurality of self-tightening constructs configured to contract onto the struts under tension.

[0007] According to one aspect of the present invention, there is provided a prosthetic valve including a frame movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly including a plurality of leaflets mounted within the frame and configured to regulate flow through the prosthetic valve. The frame includes a plurality of intersecting struts. Each leaflet includes a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely oriented tabs separating the cusp edge and the free edge.

[0008] Each cusp end portion is connected to at least one strut via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portion at a piercing point, the secondary suture being threaded through the primary suture and around at least one section of the at least one strut, the secondary suture including a plurality of self-tightening constructs, each self-tightening construct including at least one loop configured to contract around the strut under tension.

[0009] According to some embodiments, the leaflet includes a leaflet inner surface and a leaflet outer surface, and the primary suture includes a plurality of inner stitch portions disposed along the leaflet inner surface and a plurality of outer stitch portions disposed along the leaflet outer surface, each inner stitch portion and each outer stitch portion defined between respective piercing points.

[0010] According to some embodiments, the self-fastening construct is defined between two pierce points that define at least one outer stitch portion therebetween.

[0011] According to some embodiments, the at least one loop of each self-tightening construct includes two loops.

[0012] According to some embodiments, each self-tightening construct further includes a u-shaped section extending partially between at least one loop and a strut.

[0013] According to some embodiments, the secondary suture further includes a plurality of suture tensioning portions that extend over the leaflet inner surface.

[0014] According to some embodiments, at least one of the suture tensioning portions spans two or more inner or outer stitch portions.

[0015] According to some embodiments, the suture tensioning portion is pressed against the at least one primary suture portion.

[0016] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0017] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0018] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

[0019] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.3.

[0020] According to some embodiments, the cusp end portion of each leaflet includes a series of pre-formed apertures.

[0021] According to some embodiments, the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0022] According to some embodiments, the apertures are evenly spaced from one another.

[0023] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the primary suture.

[0024] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0025] According to some embodiments, the secondary suture is threaded through all consecutive penetration points.

[0026] According to some embodiments, the at least one primary suture includes two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same piercing point.

[0027] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0028] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0029] According to some embodiments, the at least one primary suture tracks the curvature of the at least one cusp edge.

[0030] According to some embodiments, the primary suture comprises a multifilament suture.

[0031] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0032] According to some embodiments, the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the leaflets and the struts to which they are attached.

[0033] According to another aspect of the present invention, there is provided a method of assembling a prosthetic valve, the method including the step of threading primary sutures in an in-and-out pattern through cusp end portions of a valve leaflet, the method further including the step of approximating the cusp end portions with the primary sutures threaded therethrough to at least one strut of a frame of the prosthetic valve, and the method further including the step of sewing secondary sutures through the primary sutures and around at least one strut in a manner to form a plurality of self-tightening constructs, each self-tightening construct being formed to include at least one loop configured to contract around the strut under tension.

[0034] According to some embodiments, sewing the secondary suture includes threading the secondary suture radially outward through the primary suture at the piercing point, thereby forming at least one loop around at least one strut.

[0035] According to some embodiments, sewing the secondary suture includes re-looping the secondary suture around at least one strut after forming the first loop, thereby forming two loops for each self-tightening construct.

[0036] According to some embodiments, sewing the secondary suture includes passing the secondary suture under at least one loop between the at least one loop and the at least one strut to form a U-shaped section.

[0037] According to some embodiments, the method further includes extending a secondary suture over the leaflet inner surface and then threading the secondary suture once more in a radially outward direction through the primary suture, thereby forming at least one suture tension portion extending over the leaflet inner surface.

[0038] According to some embodiments, the cusp end portion of each leaflet includes a series of pre-formed apertures, and threading the primary sutures includes threading the primary sutures in an in-and-out pattern through the series of pre-formed apertures.

[0039] According to another aspect of the present invention, there is provided a prosthetic valve including a frame movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly including a plurality of leaflets mounted within the frame and configured to regulate flow through the prosthetic valve. The frame includes a plurality of strut sections that intersect at junctions. Each junction is defined between two opposing axial sides, including a proximal junction side and a distal junction side; two opposing radial sides, including a medial junction side and a lateral junction side; and two opposing lateral sides, including a first lateral junction side and a second lateral junction side.

[0040] Each leaflet includes a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely oriented tabs separating the cusp edge and the free edge. Each cusp end portion is connected to at least one strut section via at least one primary suture and a secondary suture, where the at least one primary suture is threaded in an in-and-out pattern through the cusp end portion at piercing points and the secondary suture is threaded through the primary suture and wrapped around the strut section in a series of whip stitches spaced from one another along the length of the strut section.

[0041] The cusp end portion is further connected to at least one joint at the end of the strut section via a joint locking knot formed by a second suture, the joint locking knot being configured to maintain tension on a plurality of whip stitches wrapped around a corresponding strut section leading to the lateral side of the first joint.

[0042] According to some embodiments, each joint locking knot includes: (1) a transition section extending over one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; (2) a first loop extending from the transition section and extending around a strut section extending from the second joint lateral side; and (3) a second loop extending from the first loop between the transition section and the joint and folded back on itself to extend through the first loop.

[0043] According to some embodiments, the transition section extends in an oblique direction from one radial side of the junction to an opposite radial side of the junction and from one lateral side of the junction to an opposite lateral side of the junction.

[0044] According to some embodiments, both the first loop and the second loop are tightly tensioned around the junction.

[0045] According to some embodiments, each of the plurality of whip stitches wrapped around a single strut section are angled whip stitches oriented in the same direction along the length of the corresponding strut section.

[0046] According to some embodiments, the cusp end portion is sewn to at least two strut sections extending from both lateral sides of the selected junction via a plurality of whip stitches wrapped around each of the respective strut sections and a joint locking knot around the junction positioned therebetween, the plurality of whip stitches around one of the strut sections being angled in an opposite direction to the plurality of whip stitches wrapped around the other strut section.

[0047] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0048] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0049] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

[0050] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.3.

[0051] According to some embodiments, the cusp end portion of each leaflet includes a series of pre-formed apertures.

[0052] According to some embodiments, the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0053] According to some embodiments, the apertures are evenly spaced from one another.

[0054] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the primary suture.

[0055] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0056] According to some embodiments, the at least one primary suture includes two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same piercing point.

[0057] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0058] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0059] According to some embodiments, the at least one primary suture tracks the curvature of the at least one cusp edge.

[0060] According to some embodiments, the primary suture comprises a multifilament suture.

[0061] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0062] According to some embodiments, the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the leaflets and the strut sections and coaptations to which they are attached.

[0063] According to another aspect of the present invention, there is provided a method of assembling a prosthetic valve, the method including the step of threading primary sutures in an in-and-out pattern through cusp end portions of a valve leaflet, the method further including the step of approximating the cusp end portions with the primary sutures threaded therethrough to at least one strut section of a frame of the prosthetic valve, and the method further including the step of sewing secondary sutures through the primary sutures and around the at least one strut section in a manner to form a plurality of whip stitches wrapped around the strut section until a final whip stitch is formed.

[0064] The method further includes forming a joint lock knot extending from the final whip stitch around the joint at each end of the corresponding strut section, the joint lock configured to maintain tension on the plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0065] According to some embodiments, forming the joint locking knot includes extending a secondary suture from a final whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0066] According to some embodiments, forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0067] According to some embodiments, the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0068] According to some embodiments, the step of forming the joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0069] According to some embodiments, forming the transition section includes extending the secondary sutures in a diagonal direction from one radial side of the joint to an opposite radial side of the joint and from one lateral side of the joint to an opposite lateral side of the joint.

[0070] According to some embodiments, forming a plurality of whip stitches around any single strut section comprises forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0071] According to some embodiments, sewing the secondary suture around the at least one strut section includes sewing around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0072] According to some embodiments, the cusp end portion of each leaflet includes a series of pre-formed apertures, and threading the primary sutures includes threading the primary sutures in an in-and-out pattern through the series of pre-formed apertures.

[0073] According to another aspect of the present invention, there is provided a prosthetic valve including a frame movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly including a plurality of leaflets mounted within the frame and configured to regulate flow through the prosthetic valve. The frame includes a plurality of strut sections intersecting at coaptations. Each leaflet includes a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely oriented tabs separating the cusp edge and the free edge.

[0074] Each cusp end portion is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portion and the secondary suture forming a series of blind-through whip stitches spaced from one another along the length of the strut section, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section, looped around the primary suture, and passing between the primary suture and the leaflet.

[0075] According to some embodiments, the primary suture defines a series of running stitch portions, with each primary suture wrap section looped around a corresponding running stitch portion and extending between the running stitch portion and the rounded cusp end portion.

[0076] According to some embodiments, the secondary sutures do not pass through the leaflets.

[0077] According to some embodiments, the secondary sutures do not pass through the primary sutures.

[0078] According to some embodiments, the cusp end portion is further connected to at least one junction at the end of the strut section via a junction locking knot formed by a second suture. Each junction is defined between two opposing axial sides, including a proximal junction side and a distal junction side; between two opposing radial sides, including a medial junction side and a lateral junction side; and between two opposing lateral sides, including a first lateral junction side and a second lateral junction side. Each junction locking knot is configured to maintain tension on a plurality of blind whip stitches wrapped around the corresponding strut section leading to the first lateral junction side.

[0079] According to some embodiments, each joint locking knot includes: (1) a transition section extending over one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; (2) a first loop extending from the transition section and extending around a strut section extending from the second joint lateral side; and (3) a second loop extending from the first loop between the transition section and the joint and folded back on itself to extend through the first loop.

[0080] According to some embodiments, the transition section extends in an oblique direction from one radial side of the junction to an opposite radial side of the junction and from one lateral side of the junction to an opposite lateral side of the junction.

[0081] According to some embodiments, the transition section extends in an oblique direction from one radial side of the junction to an opposite radial side of the junction and from one lateral side of the junction to an opposite lateral side of the junction.

[0082] According to some embodiments, both the first loop and the second loop are tightly tensioned around the junction.

[0083] According to some embodiments, each of the plurality of blind-through whip stitches wrapped around a single strut section are angled blind-through whip stitches that are oriented in the same direction along the length of the corresponding strut section.

[0084] According to some embodiments, the cusp end portion is sewn to at least two strut sections extending from both lateral sides of the selected junction via a plurality of blind-through whip stitches wrapped around each of the respective strut sections and a joint locking knot around the junction positioned therebetween, the plurality of blind-through whip stitches around one of the strut sections being angled in an opposite direction to the plurality of blind-through whip stitches wrapped around the other strut section.

[0085] According to some embodiments, the at least one primary suture includes two primary sutures, the two primary sutures being threaded back and forth in an in-and-out pattern.

[0086] According to some embodiments, the at least one primary suture tracks the curvature of the at least one cusp edge.

[0087] According to some embodiments, the primary suture comprises a multifilament suture.

[0088] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0089] According to some embodiments, the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the leaflets and the strut sections to which they are attached.

[0090] According to another aspect of the present invention, there is provided a method of assembling a prosthetic valve, the method comprising threading primary sutures in an in-and-out pattern through cusp end portions of a valve leaflet. The method further comprises approximating the cusp end portions with the primary sutures threaded therethrough to at least one strut section of a frame of the prosthetic valve. The method further comprises looping secondary sutures around at least one strut section and around the primary suture in a manner to form a plurality of non-penetrating whip stitches wrapped around the strut section until a final non-penetrating whip stitch is formed. Each non-penetrating whip stitch includes a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section, passing between the primary suture and the valve leaflet, and looped around the primary suture.

[0091] According to some embodiments, forming each blind-through whip stitch includes extending a secondary suture across one radial side of the strut section, folding it back over the axial side of the strut, and extending it back across the opposite radial side of the strut to form a strut wrap section.

[0092] According to some embodiments, forming each blind-through whip stitch further comprises passing a secondary suture between the running stitch portion of the primary suture and the cusp end portion of the leaflet and folding it back over the running stitch portion to form a primary suture wrap section.

[0093] According to some embodiments, forming each blind-through whip stitch further comprises passing a secondary suture over the running stitch portion of the primary suture and looping it back over the running stitch portion and between the running stitch portion and the cusp end portion of the leaflet to form a primary suture wrap section.

[0094] According to some embodiments, the running stitch portion is an outer stitch portion of the primary suture.

[0095] According to some embodiments, the method further includes forming a joint locking knot extending from the final non-through whip stitch around the joint at each end of the corresponding strut section, the joint locking knot configured to maintain tension on the plurality of non-through whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0096] According to some embodiments, forming the joint locking knot includes extending a secondary suture from a final blind-through whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0097] According to some embodiments, forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0098] According to some embodiments, the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0099] According to some embodiments, the step of forming the joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0100] According to some embodiments, forming the transition section includes extending the secondary sutures in a diagonal direction from one radial side of the joint to an opposite radial side of the joint and from one lateral side of the joint to an opposite lateral side of the joint.

[0101] According to some embodiments, forming a plurality of whip stitches around any single strut section comprises forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0102] According to some embodiments, forming a plurality of whip stitches around at least one strut section includes forming a plurality of whip stitches around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0103] According to another aspect of the present invention, there is provided a prosthetic valve including a frame, a leaflet assembly mounted within the frame, and a skirt disposed about the frame. The frame is movable between a radially compressed configuration and a radially expanded configuration and includes a plurality of strut sections intersecting at coaptations. The leaflet assembly includes a plurality of leaflets configured to regulate flow through the prosthetic valve. The skirt includes a skirt proximal end and a skirt distal end.

[0104] Each joint is defined between two opposite axial sides, including a joint proximal side and a joint distal side; between two opposite radial sides, including a joint medial side and a joint lateral side; and between two opposite lateral sides, including a joint first lateral side and a joint second lateral side.

[0105] The skirt proximal end is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the skirt proximal end at a piercing point, and the secondary suture being threaded through the primary suture and wrapped around the strut section in a series of whip stitches spaced from each other along the length of the strut section.

[0106] The proximal end of the skirt is further connected to at least one joint at the end of the strut section via a joint locking knot formed by a second suture, the joint locking knot being configured to maintain tension on a plurality of whip stitches wrapped around a corresponding strut section leading to the lateral side of the first joint.

[0107] According to some embodiments, the proximal end of the skirt follows a zigzag pattern.

[0108] According to some embodiments, the at least one primary suture follows a zigzag pattern at the proximal end of the skirt.

[0109] According to some embodiments, each joint locking knot includes: (1) a transition section extending over one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; (2) a first loop extending from the transition section and extending around a strut section extending from the second joint lateral side; and (3) a second loop extending from the first loop between the transition section and the joint and folded back on itself to extend through the first loop.

[0110] According to some embodiments, the transition section extends in an oblique direction from one radial side of the junction to an opposite radial side of the junction and from one lateral side of the junction to an opposite lateral side of the junction.

[0111] According to some embodiments, both the first loop and the second loop are tightly tensioned around the junction.

[0112] According to some embodiments, each of the plurality of whip stitches wrapped around a single strut section are angled whip stitches oriented in the same direction along the length of the corresponding strut section.

[0113] According to some embodiments, the skirt proximal end is sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of whip stitches wrapped around each of the respective strut sections and a junction locking knot around the junction positioned therebetween, the plurality of whip stitches around one of the strut sections being angled in an opposite direction to the plurality of whip stitches wrapped around the other strut section.

[0114] According to some embodiments, the skirt distal end is connected to at least one strut section at the inflow end portion of the valve via at least one additional primary suture and an additional secondary suture, the at least one additional primary suture being threaded in an in-and-out pattern through the inflow end portion at the piercing point, and the additional secondary suture being threaded through the primary suture and wrapped around the strut section at the inflow end portion in a series of whip stitches spaced from each other along the length of the strut section, and the skirt distal end is further connected to at least one junction at the end of the strut section at the inflow end portion via an additional junction locking knot.

[0115] According to some embodiments, the additional primary suture follows the shape of the strut section disposed around the inflow end portion.

[0116] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0117] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0118] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

[0119] According to some embodiments, the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.3.

[0120] According to some embodiments, the proximal end of the skirt includes a series of pre-formed apertures.

[0121] According to some embodiments, the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0122] According to some embodiments, the apertures are evenly spaced from one another.

[0123] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the primary suture.

[0124] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0125] According to some embodiments, the at least one primary suture includes two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same piercing point.

[0126] According to some embodiments, the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0127] According to some embodiments, the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0128] According to some embodiments, the primary suture comprises a multifilament suture.

[0129] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0130] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0131] According to another aspect of the present invention, there is provided a method of assembling a prosthetic valve, the method including threading a primary suture in an in-and-out pattern through a proximal skirt end of a skirt. The method further includes approximating the proximal skirt end, with the primary suture threaded therethrough, to at least one strut section of a frame of the prosthetic valve. The method further includes sewing a secondary suture through the primary suture and around the at least one strut section in a manner to form a plurality of whip stitches wrapped around the strut section to a final whip stitch. The method further includes forming a joint locking knot extending from the final whip stitch around a joint at each end of the corresponding strut section, the joint locking knot configured to maintain tension on the plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0132] According to some embodiments, forming the joint locking knot includes extending a secondary suture from a final whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0133] According to some embodiments, forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0134] According to some embodiments, the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0135] According to some embodiments, the step of forming the joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0136] According to some embodiments, forming the transition section includes extending the secondary sutures in a diagonal direction from one radial side of the joint to an opposite radial side of the joint and from one lateral side of the joint to an opposite lateral side of the joint.

[0137] According to some embodiments, forming a plurality of whip stitches around any single strut section comprises forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0138] According to some embodiments, sewing the secondary suture around the at least one strut section includes sewing around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0139] According to some embodiments, the proximal end of the skirt includes a series of pre-formed apertures, and threading the primary suture includes threading the primary suture in an in-and-out pattern through the series of pre-formed apertures.

[0140] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0141] According to another aspect of the present invention, there is provided a prosthetic valve including a frame, a leaflet assembly mounted within the frame, and a skirt disposed about the frame. The frame is transitionable between a radially compressed configuration and a radially expanded configuration and includes a plurality of strut sections intersecting at coaptations. The leaflet assembly includes a plurality of leaflets configured to regulate flow through the prosthetic valve. The skirt includes a skirt proximal end and a skirt distal end.

[0142] The skirt proximal end is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the skirt proximal end, the secondary suture forming a series of blind-through whip stitches spaced from one another along the length of the strut section, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, the primary suture wrap section extending from the strut wrap section and looped around the primary suture, skirt It passes between

[0143] According to some embodiments, the proximal end of the skirt follows a zigzag pattern.

[0144] According to some embodiments, the at least one primary suture follows a zigzag pattern at the proximal end of the skirt.

[0145] According to some embodiments, the primary suture defines a series of running stitch portions, with each primary suture wrap section looped around a corresponding running stitch portion and extending between the running stitch portion and the proximal end of the skirt.

[0146] According to some embodiments, the secondary sutures do not pass through the skirt.

[0147] According to some embodiments, the secondary sutures do not pass through the primary sutures.

[0148] According to some embodiments, each joint is defined between two opposing axial sides, including a proximal joint side and a distal joint side; two opposing radial sides, including an inner joint side and an outer joint side; and two opposing lateral sides, including a first lateral joint side and a second lateral joint side. The proximal end of the skirt is further connected to at least one joint at an end of a strut section via a joint locking knot formed by a second suture, the joint locking knot being configured to maintain tension on a plurality of blind-through whipstitches wrapped around the corresponding strut section leading to the first lateral joint side.

[0149] According to some embodiments, each joint locking knot includes: (1) a transition section extending over one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; (2) a first loop extending from the transition section and extending around a strut section extending from the second joint lateral side; and (3) a second loop extending from the first loop between the transition section and the joint and folded back on itself to extend through the first loop.

[0150] According to some embodiments, the transition section extends in an oblique direction from one radial side of the junction to an opposite radial side of the junction and from one lateral side of the junction to an opposite lateral side of the junction.

[0151] According to some embodiments, both the first loop and the second loop are tightly tensioned around the junction.

[0152] According to some embodiments, each of the plurality of whip stitches wrapped around a single strut section are angled whip stitches oriented in the same direction along the length of the corresponding strut section.

[0153] According to some embodiments, the skirt proximal end is sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a joint locking knot around the junction positioned therebetween, the plurality of non-penetrating whip stitches around one of the strut sections being angled in an opposite direction to the plurality of non-penetrating whip stitches wrapped around the other strut section.

[0154] According to some embodiments, the skirt distal end is connected to at least one strut section at the inflow end portion of the valve via at least one additional primary suture and an additional secondary suture, the at least one additional primary suture being threaded in an in-and-out pattern through the inflow end portion at the piercing point, and the additional secondary suture being threaded through the primary suture and wrapped around the strut section at the inflow end portion in a series of whip stitches spaced from each other along the length of the strut section, and the skirt distal end is further connected to at least one junction at the end of the strut section at the inflow end portion via an additional junction locking knot.

[0155] According to some embodiments, the additional primary suture follows the shape of the strut section disposed around the inflow end portion.

[0156] According to some embodiments, the primary suture comprises a multifilament suture.

[0157] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0158] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0159] According to another aspect of the present invention, there is provided a method of assembling a prosthetic valve, the method including threading a primary suture in an in-and-out pattern through a proximal skirt end of a skirt. The method further includes approximating the proximal skirt end with the threaded primary suture to at least one strut section of a frame of the prosthetic valve. The method further includes looping a secondary suture around at least one strut section and around the primary suture in a manner to form a plurality of non-through whip stitches wrapped around the strut section up to a final non-through whip stitch, each non-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section and passing between the primary suture and the proximal skirt end around the primary suture.

[0160] According to some embodiments, forming each blind-through whip stitch includes extending a secondary suture across one radial side of the strut section, folding it back over an axial side of the strut section, and extending it back across the opposite radial side of the strut section to form a strut wrap section.

[0161] According to some embodiments, the step of forming each blind-through whip stitch further includes the step of passing a secondary suture between the running stitch portion of the primary suture and the proximal end of the skirt and folding it back over the running stitch portion to form a primary suture wrap section.

[0162] According to some embodiments, forming each blind-through whip stitch further comprises passing a secondary suture over the running stitch portion of the primary suture and looping it back over the running stitch portion and between the running stitch portion and the skirt proximal end to form a primary suture wrap section.

[0163] According to some embodiments, the skirt is an outer skirt and the running stitch portion is an inner stitch portion of the primary suture.

[0164] According to some embodiments, the method further includes forming a joint locking knot extending from the final non-through whip stitch around the joint at each end of the corresponding strut section, the joint locking knot configured to maintain tension on the plurality of non-through whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0165] According to some embodiments, forming the joint locking knot includes extending a secondary suture from a final blind-through whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0166] According to some embodiments, forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0167] According to some embodiments, the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0168] According to some embodiments, the step of forming the joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0169] According to some embodiments, forming the transition section includes extending the secondary sutures in a diagonal direction from one radial side of the joint to an opposite radial side of the joint and from one lateral side of the joint to an opposite lateral side of the joint.

[0170] According to some embodiments, forming a plurality of whip stitches around any single strut section comprises forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0171] According to some embodiments, forming a plurality of whip stitches around at least one strut section includes forming a plurality of whip stitches around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0172] Particular embodiments of the present invention may include some, all, or none of the above advantages. Additional advantages may become readily apparent to those skilled in the art from the figures, specification, and claims contained therein. Aspects and embodiments of the present invention are further described in the following specification and appended claims.

[0173] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification (including definitions) shall govern. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more," unless the context clearly dictates otherwise.

[0174] The following embodiments and aspects thereof are described and illustrated in connection with systems, tools, and methods that are intended to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems are reduced or eliminated, while other embodiments are associated with other advantages or improvements.

[0175] Several embodiments of the present invention are described herein with reference to the accompanying drawings. The description, together with the drawings, will make apparent to those skilled in the art how several embodiments may be practiced. The drawings are for illustrative purposes and no attempt is made to show structural details of the embodiments in more detail than necessary for a fundamental understanding of the invention. For clarity, some objects shown in the drawings have not been drawn to scale. [Brief explanation of the drawings]

[0176] [Figure 1A] FIG. 1 is a perspective view of a mechanically expandable prosthetic valve, according to some embodiments. [Figure 1B] FIG. 1 is a perspective view of a balloon-expandable prosthetic valve, according to some embodiments. [Figure 2] FIG. 1 illustrates a single leaflet, according to some embodiments. [Figure 3] 1A-1C illustrate a leaflet assembly defined by three leaflets prior to assembly, according to some embodiments. [Figure 4] 10A-10C are enlarged cross-sectional views through the cusp end portions of the leaflets with primary sutures threaded in an in-and-out pattern through the cusp end portions of the leaflets, according to some embodiments. [Figure 5A] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to struts of a frame, according to some embodiments. [Figure 5B] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to struts of a frame, according to some embodiments. [Figure 5C] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to struts of a frame, according to some embodiments. [Figure 5D] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to struts of a frame, according to some embodiments. [Figure 5E] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to struts of a frame, according to some embodiments. [Figure 6] 1A-1C illustrate exemplary configurations of leaflets connected to struts via primary and secondary sutures, according to some embodiments. [Figure 7] FIG. 10 is an enlarged cross-sectional view through a cusp end portion of a valve leaflet with two primary sutures threaded in an in-and-out pattern through the cusp end portion, according to some embodiments. [Figure 8] 10A-10C illustrate another exemplary configuration of leaflets coupled to struts via primary and secondary sutures, according to some embodiments. [Figure 9A] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 9B] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 9C] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 9D] 10A-10C illustrate various stages of an exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 10] FIG. 1B is a partial view of a prosthetic valve with leaflets connected to multiple strut sections and coaptations, according to some embodiments. [Figure 11A] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 11B] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 11C] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 11D] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 12A] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 12B] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 12C] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 12D] 10A-10C illustrate various stages of another exemplary technique for connecting leaflets along their cusp end portions to strut sections and coaptations of a frame, according to some embodiments. [Figure 13] 10A-10C illustrate another exemplary stitching configuration. [Figure 14] 10A-10C illustrate yet another exemplary stitching configuration. [Figure 15] FIG. 1 is a perspective view of a prosthetic valve with an outer skirt, according to some embodiments. [Figure 16] 16 is a partial view of the prosthetic valve of FIG. 15 with a skirt connected to multiple strut sections and joints, according to some embodiments. [Figure 17] FIG. 1 is a perspective view of another exemplary prosthetic valve with an outer skirt, according to some embodiments. [Figure 18] 18 is a partial view of the prosthetic valve of FIG. 17 with a skirt connected to multiple strut sections and joints, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0177] In the following description, various aspects of the present disclosure will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of different aspects of the present disclosure. However, it will also be apparent to those skilled in the art that the present disclosure may be practiced without the specific details presented herein. Moreover, well-known features may be omitted or simplified so as not to obscure the disclosure. To avoid undue clutter from having too many reference numbers and leads on a particular drawing, some components will be introduced through one or more drawings and will not be explicitly identified in all subsequent drawings that contain that component.

[0178] 1A and 1B show perspective views of two exemplary types of prosthetic valves 100, according to some embodiments. It will be appreciated that reference numbers with a prime mark (') or double prime mark (') are used throughout FIGS. 1A-1B to indicate different embodiments of the same element. The disclosed device and system embodiments may include any combination of different embodiments of the same element. In particular, any reference to an element without a single prime or double prime mark may refer to any alternative embodiment of the same element indicated by a single prime or double prime mark.

[0179] The prosthetic valve 100 is deliverable to a target site in a patient over a catheter (not shown) and is radially expandable and compressible between a radially compressed (or crimped) configuration and a radially expanded configuration (shown in FIGS. 1A-1B). The expanded configuration can include a range of diameters to which the valve 100 can expand between the compressed configuration and the maximum diameter reached in the fully expanded configuration. Thus, multiple partially expanded configurations can relate to any expanded diameter between the radially compressed or crimped configuration and the maximum expanded configuration. The prosthetic valve 100 of the present disclosure can include any prosthetic valve configured to be installed within the native aortic valve, native mitral valve, native pulmonary valve, and native tricuspid valve.

[0180] As used herein, the term "plurality" means two or more.

[0181] As described above, the prosthetic valve 100 can be delivered to the site of implantation via a delivery assembly carrying the valve 100 in a radially compressed or crimped configuration toward a target site and seated against the native anatomy by expanding the valve 100 via various expansion mechanisms. FIG. 1A shows an exemplary mechanically expandable valve 100′, and all reference numbers marked with a prime (′) shown in FIG. 1A refer to similar elements contained within the mechanically expandable valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism typically includes multiple actuator assemblies, which are releasably coupled to respective actuation arm assemblies of the delivery device and controlled via the handle of the delivery device for actuating the actuator assemblies to expand the prosthetic valve to a desired diameter.

[0182] FIG. 1B illustrates an exemplary balloon-expandable valve 100″; all reference numbers accompanied by a double prime symbol (″) shown in FIG. 1B refer to like elements contained within the balloon-expandable valve. Balloon-expandable valves generally involve a procedure in which a balloon within the prosthetic valve is inflated, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with the delivery device. While mechanically expandable valve 100′ and balloon-expandable valve 100″ are described and illustrated in connection with FIGS. 1A-1B , it should be clear that prosthetic valve 100 can include other expansion mechanisms (e.g., self-expandable valves, etc.). Self-expandable valves include a frame configured to automatically expand as soon as an outer retaining structure (e.g., a capsule or portion of a shaft (not shown)) is withdrawn proximally relative to the prosthetic valve.

[0183] The prosthetic valve 100 can include an inflow end portion 104 defining an inflow end 105 and an outflow end portion 102 defining an outflow end 103. The prosthetic valve 100 can define a valve longitudinal axis 10, which extends through the inflow end portion 104 and the outflow end portion 102. In some cases, the outflow end 103 is the proximal end of the prosthetic valve 100 and the inflow end 105 is the distal end of the prosthetic valve 100. Alternatively, the outflow end can be the proximal end of the prosthetic valve and the inflow end can be the distal end of the prosthetic valve, for example, depending on the valve delivery approach.

[0184] As used herein, the term "proximal" generally refers to the location, direction, or portion of any device or device component that is closer to the user and farther away from the implantation site.

[0185] As used herein, the term "distal" generally refers to the location, direction, or portion of any device or device component that is farther away from the user and closer to the implantation site.

[0186] As used herein, the term "outflow" refers to the region of the prosthetic valve from which blood flows out through the valve 100, for example, between the valve longitudinal axis 10 and the outflow end 103.

[0187] As used herein, the term "inflow" refers to the region of the prosthetic valve through which blood enters the valve 100, for example, between the inflow end 105 and the valve longitudinal axis 10.

[0188] The valve 100 includes an annular frame 106 movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly 130 mounted within the frame 106. The frame 106 may be made from a variety of suitable materials, including a plastically deformable material (e.g., but not limited to, stainless steel, a nickel-based alloy (e.g., cobalt-chromium or a nickel-cobalt-chromium alloy, e.g., MP35N alloy), a polymer, or a combination thereof). When constructed from a plastically deformable material, the frame 106 (e.g., frame 106″ (and thus the balloon-expandable valve 100″)) may be crimped into a radially compressed configuration onto a delivery shaft (not shown) and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 106″ may be made from a shape-memory material (e.g., but not limited to, a nickel-titanium alloy (e.g., Nitinol)). When constructed from a shape memory material, the frame 106 (e.g., the frame 106′ (and thus the mechanically expandable valve 100′)) can be crimped into a radially compressed configuration and restrained in the compressed configuration by insertion into the shaft or equivalent mechanism of a delivery device (not shown).

[0189] In the example illustrated in FIGS. 1A-1B, the frame 106 is an annular, stent-like structure including multiple intersecting struts 110. In this application, the term "strut" encompasses vertical struts, angled struts, attachment posts, commissure windows, and any similar structures described by U.S. Patent Nos. 6,275,999 and 6,329,262, which are incorporated herein by reference. The struts 110 can be any elongated member or portion of the frame 106. The frame 106 can have one or more rows of cells 108 defined by the intersecting struts 110. The frame 106 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inflow end 105 to the outflow end 103 of the frame, as shown, or the frame can vary in diameter along its height, as disclosed in U.S. Patent No. 6,275,999, which is incorporated herein by reference.

[0190] The end portions of the struts 110 form an apex 120 at the outflow end 103 and an apex 118 at the inflow end 105. The struts 110 may intersect at additional non-apex junctions 116 formed between the outflow apex 120 and the inflow apex 118. The non-apex junctions 116 may be evenly or unevenly spaced apart from each other and / or from the apexes 120, 118 between the outflow end 103 and the inflow end 105.

[0191] According to some embodiments, the struts 110 are arranged in a lattice-type pattern. In the exemplary embodiment illustrated in Figure 1A, the struts 110' are positioned obliquely or offset at an angle relative to the valve longitudinal axis 10 when the valve 100' is in the expanded position, and are also offset radially from the valve longitudinal axis 10. It will be apparent that the struts 110' can be offset by angles other than those shown in Figure 1B (e.g., oriented substantially parallel to the valve longitudinal axis 10).

[0192] According to some embodiments, the struts 110′ are pivotally connected to one another. The frame 106′ can include openings or apertures in the areas of the inflow apexes 118′, outflow apexes 120′, and non-apex junctions 116′ of the struts 110′. Respective hinges can be included where the apertures of the struts 110′ overlap one another via fasteners (e.g., rivets, pins, etc.) extending through the apertures. The hinges can allow the struts 110′ to pivot relative to one another when the frame 106′ is radially expanded or compressed.

[0193] According to some embodiments, the struts 110 include a plurality of angled struts and vertical struts. In the exemplary embodiment illustrated in FIG. 1B, the frame 106" includes a plurality of angled struts 110" and an axially extending strut 114. In such embodiments, the struts are not necessarily connected to one another via respective hinges, but are otherwise pivotable or bendable relative to one another to allow for frame expansion or compression. For example, the frame 106" may be formed from a single piece of material (e.g., metal tubing, etc.) via various processes (e.g., but not limited to, laser cutting, electroforming, and / or physical vapor deposition, etc.) while retaining the ability to radially collapse / expand in the absence of hinges, etc.

[0194] The valve leaflet assembly 130 includes a plurality of leaflets 132 (e.g., three leaflets) that are at least partially positioned within the frame 106 and are configured to regulate the flow of blood through the prosthetic valve 100 from the inflow end 105 to the outflow end 103. While three leaflets 132 arranged to collapse in a tricuspid configuration are shown in the exemplary embodiment depicted in FIGS. 1A-1B, it will be apparent that the prosthetic valve 100 can include any other number of leaflets 132. The leaflets 132 can be made from a flexible material (derived from a biological material (e.g., bovine pericardium or pericardium from other sources)), a biocompatible synthetic material, or other suitable material as known in the art and as described, for example, in U.S. Patent Nos. 6,279,949; 6,279,949; and 6,279,949, which are incorporated herein by reference.

[0195] FIG. 2 shows a single representative leaflet 132, and FIG. 3 shows three separated leaflets prior to attachment to the frame 106 and to each other, which collectively define the leaflet assembly 130, according to some embodiments. Each leaflet 132 has a rounded cusp end portion 134 defining a cusp edge 135 opposite a free edge 136, and a pair of generally oppositely oriented tabs 138 separating the cusp edge 135 and the free edge 136. The cusp edge 135 forms a single scallop. The leaflets 132 further include an inner surface 152 and an outer surface 154, with the inner surface 152 defined as the surface facing the valve longitudinal axis 10 and the outer surface 154 opposite it, facing the frame 106.

[0196] When the leaflets 132 are coupled to the frame and to each other, the lower edge of the resulting leaflet assembly 130 desirably has an undulating, curved, scalloped shape. By forming the leaflets with this scalloped geometry, stress on the leaflets 132 is reduced, which improves valve durability. Moreover, due to the scalloped shape, folds and ripples in the abdomen of each leaflet (which can cause premature calcification in those areas) can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller and more uniform crimped profile at the inflow end of the valve.

[0197] The leaflets 132 define a non-planar coaptation plane (not annotated) when their free edges 136 coapt to one another to seal against blood flow through the prosthetic valve 100. The leaflets 132 can be secured to one another at their tabs 138 to form commissures 140 of the leaflet assembly 130, which can be secured directly or indirectly to structural elements (e.g., commissure posts, etc.) connected to or embedded within the frame 106. When secured to two other leaflets 132 to form the leaflet assembly 130, the cusp edges 135 of the leaflets 132 collectively form the scalloped lower edge portion of the leaflet structure 130.

[0198] According to some embodiments, the mechanically expandable valve 100′ includes a plurality of actuator assemblies 122 configured to facilitate expansion of the valve 100′ and, in some cases, to lock the valve in the expanded configuration and prevent its unintentional recompression. While FIG. 1A illustrates three actuator assemblies 122 mounted to and evenly spaced about the inner surface of the frame 106′, it should be clear that a different number of actuator assemblies 122 can be utilized, that the actuator assemblies 122 can be mounted to the frame 106′ about its outer surface, and that the circumferential spacing between the actuator assemblies 122 can be unequal. 1B, the actuator assembly 122 can also serve as a commissure post, and the commissures 140 of the leaflet assembly 130 can be coupled to the commissure post. Details regarding the structure and operation of mechanically expandable valves and their delivery systems are described in U.S. Patent Nos. 6,213,299; 6,213,299; 6,213,299; and 6,213,299, as well as U.S. patent application Ser. Nos. 62 / 870,372 and 62 / 776,348, all of which are incorporated herein by reference.

[0199] According to some embodiments (such as the exemplary embodiment illustrated in FIG. 1B ), the upper row of cells includes a plurality of axially extending window frame portions 112 (which define commissure windows) and a plurality of axially extending struts 114. Each axial strut 114 and each window frame portion 112 extends from a junction 116″ defined by the convergence of the lower ends of two angled struts 110″ to another junction 116″ defined by the convergence of the upper ends of two angled struts 110″. Each commissure window frame portion 112 attaches to a respective commissure 140 of the leaflet structure 130.

[0200] Additional frame configurations can include commissure posts attached to the frame that are configured to receive the commissures 140, either extending through window portions defined therein or supporting commissure attachment thereto in various other ways. Alternatively, some of the cells 108 may be configured to receive the commissures 140 attached thereto. For example, the cells 108 in the top row may be configured to receive the tabs 138 of the valve leaflets 132. Further details regarding prosthetic valves, including the manner in which the commissures may be attached to their frames, are described in U.S. Patent Nos. 5,629,299; 5,723,333; 5,723,333; 5,723,333; U.S. Patent Nos. 5,723,29 ... and PCT Application No. PCT / US2019 / 61392, all of which are incorporated herein by reference. Any of the techniques and mechanisms disclosed in the prior art may be used to connect (directly or indirectly) the commissures 140 to the frame 106 .

[0201] According to some embodiments, the prosthetic valve 100 may further include a skirt 123 (e.g., an outer skirt 124 (e.g., shown in FIGS. 15 and 17 ) mounted over the outer surface of the frame 106), which is configured to function as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus (to which the prosthetic valve 100 is mounted), thereby reducing the risk of paravalvular leakage through the prosthetic valve 100. Such an outer skirt may be made from a variety of suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue).

[0202] According to some embodiments, the primary sutures 144 are threaded through the cusp end portions 134 in an in-and-out pattern (also known in the art as a running stitch pattern). FIG. 3 shows the primary sutures 144 being sewn along the cusp end portions 134 of the leaflets 132. FIG. 4 shows an enlarged cross-sectional view through the cusp end portions 134 and the primary sutures 144 threaded therethrough. As shown, the running stitches extend through the piercing points 150 in an in-and-out pattern along the cusp end portions 134, thereby defining a plurality of running stitch portions, including a plurality of inner stitch portions 146 disposed along the leaflet inner surface 152 and a plurality of outer stitch portions 148 disposed along the leaflet outer surface 154, with each inner stitch portion 146 and each outer stitch portion 148 defined between a pair of consecutive piercing points 150. Optionally, but in some embodiments preferably, the primary suture 144 tracks the curvature of the cusp edge 135, meaning that the primary suture 144 runs along or generally parallel to the cusp edge 135.

[0203] 5A-5E , exemplary techniques for connecting the leaflets 132 along their cusp end portions 134 to at least one section of at least one strut 110 of the frame 106 will now be discussed in accordance with the present teachings. As shown in FIG. 5A , the cusp end portions 134 (through which the primary sutures are threaded in an in-and-out pattern) are approximated to the struts 110 such that the cusp end portions 134 are preferably positioned radially inward on the inside of the struts 110 (optionally in contact with the inside of the struts 110). According to some embodiments, secondary sutures 156 are sewn through the primary sutures 144 and around at least one section of the at least one strut 110, the secondary sutures 156 including a plurality of self-tightening constructs 158. Each self-tightening construct 158 ​​includes at least one loop configured to contract under tension around the strut 110.

[0204] 5A-5E as having a rectangular cross-section, it will be clear that this is for illustrative purposes only and that the cross-section of strut 110 can have a rounded, circular, polygonal, irregular, or shape that varies along the length of the strut. It is also possible for the cross-section of a strut to remain the same shape but vary in size along the length of the strut.

[0205] The self-tightening construct 158 ​​is formed by threading a secondary suture 156 radially outward through the primary suture 144 at the piercing point 150a and by forming at least one loop 160 around the strut (such as, for example, loop 160a shown in FIG. 5B). According to some embodiments, the self-tightening construct 158 ​​includes two or more loops 160 around the strut 110. For example, the secondary suture can be looped again to form a second loop 160b around the strut 110, as shown in FIG. 5C. While two loops 160a and 160b are described and illustrated in connection with FIGS. 5A-5E, it will be clear that the self-tightening construct 158 ​​can include any other number of loops in alternative variations.

[0206] 5D, secondary suture 156 is then passed under at least one loop 160 (e.g., between both loops 160a, 160b and strut 110) to form a generally horseshoe-shaped (or U-shaped) section 162, which is then threaded radially inwardly through primary suture 144 at pierce point 150b. Thus, a resulting self-fastening construct 158 ​​is defined between two pierce points 150 that define at least one outer stitch portion 148 therebetween.

[0207] The "radially inward" direction is the direction toward the valve longitudinal axis 10, and the "radially outward" direction is oriented in the opposite direction, away from the valve longitudinal axis 10.

[0208] The secondary suture 156 further includes a plurality of suture pulling portions 164 that extend over the leaflet inner surface 152 and may be defined between successive self-fastening constructs 158. As shown in FIG. 5E , the suture pulling portions 164 of the secondary suture 156 are defined by extending the secondary suture 156 over the leaflet inner surface 152 (e.g., parallel to at least one inner stitch portion 146) and then threading the secondary suture 156 once more in a radially outward direction through the primary suture 144 at successive piercing points 150 c (at which points another self-fastening construct 158 ​​may be formed in a similar manner). FIG. 5E shows a section of a stitch pattern including three exemplary self-fastening constructs 158.

[0209] The self-tightening constructs 158 are configured to tighten their grip on the valve leaflets 132 as their cusp end portions 134 are pulled radially inward. During diastole, the leaflets 132 collapse radially inward, effectively closing the prosthetic valve. This collapse exerts a radially inward-directed pulling force on the cusp end portions 134, which tends to pull the suture pulling portions 164 radially inward with it. The suture pulling portions 164 (disposed on the leaflet inner surface 152) pull the tails on either side of each self-tightening construct 158 ​​along with them, causing the at least one loop 160 to contract around the strut 110. This contraction reduces the diameter of the at least one loop 160, thus forming a mechanical interface between the outer surface of the strut 110 and the inner surface of the at least one loop 160. This contraction results in static friction between the inner and outer surfaces at the mechanical interface, causing at least one loop 160 of each self-tightening construct 158 ​​to tighten in a reduced size or diameter configuration in which tension can be maintained. In other words, the loops 160 are configured to reduce in diameter when tension is applied to both end portions of the self-tightening construct 158, which increases the grip of the secondary sutures 156 around the struts 110, thereby preventing the leaflets 132 from sliding over the struts 110 along the resulting scallop line.

[0210] Advantageously, the primary sutures 144 are threaded in an in-and-out pattern through the cusp end portions 134, allowing the primary sutures 144 to act as pledgets or cushions between the secondary sutures 156 and the leaflets 132. For example, a suture tension portion 164 (disposed on the leaflet inner surface 152) may press against the inner stitch portion 146 of the primary suture 144 during repeated diastolic and systolic cycles, acting as a pledget or cushion to prevent direct abrasion that might otherwise be inflicted on the leaflets 132.

[0211] As used herein with respect to either primary suture 144 or secondary suture 156 (as well as secondary suture 170, described further below), the term "suture" includes, but is not limited to, polymeric materials, threads, strands, fibers, wires, other spoolable materials, organic and inorganic materials, or any other material acceptable for medical use for threading and / or joining together components used in various embodiments of valve 100. Primary suture 144 can be a multifilament suture (e.g., Ethibond Excel® PET thread (Johnson & Johnson, New Brunswick, NJ)), among other types of sutures. Secondary suture 156 (as well as secondary suture 170, which will be described further below) can include ultra-high molecular weight polyethylene (UHMwPE), such as FORCE FIBER® suture (Teleflex, Wayne, Pa.) or DYNEEMA® fiber (Koninklijke DSM, the Netherlands), among other types of suture.

[0212] Preferably, the diameter of the secondary suture 156 is sufficiently smaller than the diameter of the primary suture 144 so that threading the secondary suture 156 through the primary suture 144 does not tear or destroy the primary suture 144. The ratio of the diameter of the secondary suture 156 to the diameter of the primary suture 144 is defined as the secondary suture to primary suture diameter ratio. According to some embodiments, the secondary suture to primary suture diameter ratio is less than 0.8. According to some embodiments, the secondary suture to primary suture diameter ratio is less than 0.5. According to some embodiments, the secondary suture to primary suture diameter ratio is less than 0.3.

[0213] In prior art prosthetic valve devices, the inner skirt is attached to the inner surface of the frame, providing a more suitable attachment surface for the valve leaflets. In contrast, the presently disclosed attachment configuration does not require the use of an intermediate fabric strip. This is because the primary sutures 144 serve as a support structure, and the leaflets 132 can be attached to the frame 106 through the support structure via secondary sutures 156 that are threaded through the primary sutures 144. Fabric strips along the inner surface of the frame 106 pose a risk of promoting tissue ingrowth and proliferation after implantation. Therefore, the absence of such fabric or textile components along the inside of the frame significantly reduces this risk, thereby improving the long-term durability and functionality of the valve.

[0214] In accordance with a preferred embodiment of the present invention, the leaflet attachment to the prosthetic valve frame along the scalloped edges of the leaflets lacks an intermediate fabric strip and / or cloth therebetween. While tissue ingrowth may still occur along the suture material (e.g., primary suture 144, etc.), the overall surface area of ​​the suture is significantly smaller than that of traditionally used fabric strips that serve as, for example, inner skirt components.

[0215] As shown, attachment of the leaflets 132 to the struts 110 of the frame 106 is achieved via secondary sutures 156, which are threaded through the primary sutures 144 instead of being threaded directly through the leaflet material. The primary sutures 144 therefore act as reinforcing members that resist suture tearing along the cusp end portions 134, thereby reducing stress concentrations on the leaflets 132 near the scallop line. Advantageously, in the region of leaflet attachment to the frame, forces applied to the leaflets 132 during transitions between an open state and a closed or coapted state are distributed along the length of the primary sutures 144. In such a manner, the primary sutures 144 act as force distribution elements that enhance the durability of the leaflets 132 over time because forces are distributed substantially evenly along their length.

[0216] 2, the leaflets 132, in some embodiments, may be provided with a series of pre-formed apertures 142 along their cusp end portions 134, which are configured to receive primary sutures 144 and to define piercing points 150, which may extend in an in-and-out pattern through the piercing points 150. In such embodiments, the apertures 142 may serve as the piercing points 150. The apertures 142, in some embodiments, may be evenly spaced from one another.

[0217] Secondary sutures 156 are threaded through primary sutures 144 at pierce points 150 (potentially within apertures 142). According to some embodiments, secondary sutures 156 extend through primary sutures 144 at each pierce point 150. Alternatively, secondary sutures 156 can extend through only some of the pierce points 150, as will be disclosed further herein below.

[0218] In such an embodiment, because the primary suture 144 is threaded through the pre-formed aperture 142 along the cusp end portion 134, the precision of the penetration point 150 for each of the primary suture 144 and / or secondary suture 156 can be preset, leading to more accurate placement of the suture and less error.

[0219] The apertures 142 are sized to receive the primary sutures 144. According to some embodiments, the diameter of the apertures 142 is equal to or less than the diameter of the primary sutures 144 such that each aperture 142 securely holds the primary suture 144 extending therethrough as the primary suture 144 passes therethrough. Because the secondary sutures 156 expand outwardly the boundaries of the primary sutures 144 in the penetration zone, alternative embodiments may include apertures 142 having diameters equal to or less than the combined diameters of the primary sutures 144 and secondary sutures 156 such that the aperture 142 securely holds both therein as the secondary suture 156 extends through the primary suture 144 within the aperture 142.

[0220] According to some embodiments, cusp end portion 134 includes markings that can follow the undulating scallop line, such as by tracking the curvature of cusp edge 135. Such markings can be utilized as an alternative to or in addition to apertures 142, and can further assist the assembler in sewing primary suture 144 therealong.

[0221] According to some embodiments, as shown in FIG. 5E, the secondary suture 156 is threaded through all of the successive piercing points 150 such that each self-tightening construct 158 ​​is positioned over a single outer stitch portion 148 and each suture tension portion 164 spans the length of a single inner stitch portion 146.

[0222] According to alternative embodiments, the secondary suture 156 is not necessarily threaded through all consecutive piercing points 150, but may in fact skip over one or more piercing points 150, allowing a single suture pulling portion 164 to extend over two or more inner or outer stitching portions 146, 148. FIG. 6 shows an exemplary configuration in which each self-tightening construct 158 ​​is positioned over a single outer stitching portion 148, while the suture pulling portion 164 extends over two inner stitching portions 146 and a single outer stitching portion 148 positioned therebetween. It will be understood that other configurations are also contemplated in which either the self-tightening constructs 158 and / or the suture pulling portion 164 are threaded through non-consecutive piercing points 150.

[0223] The term "discontinuous pierce points" refers to any set of pierce points that includes at least one additional pierce point 150 therebetween. Advantageously, the self-fastening configuration of the secondary suture 156 allows it to be threaded through the discontinuous pierce points 150 while retaining a sufficient grip to prevent, or at least significantly reduce, lateral movement of the cusp end portion 134 on the strut 110. Accordingly, the number and location of the self-fastening constructs 158 may be designed and modified in a variety of different ways based on the desired attachment points and to facilitate easier installation by the assembler of the valve 100.

[0224] According to some embodiments, two primary sutures 144 are threaded in opposite directions in an in-and-out pattern through the same piercing point 150. Figure 7 shows a cross-sectional view of a cusp end portion 134 similar to the view shown in Figure 4, except that two primary sutures 144a and 144b are threaded in opposite directions through the same piercing point 150, such that each pair of consecutive piercing points 150 defines both an inner stitch portion 146 of one of the primary sutures and an outer stitch portion 148 of the other primary suture. Figure 8 shows a secondary suture 156 being threaded through a cusp end portion 134 including two primary sutures 144 as shown in Figure 7. Advantageously, this configuration results in a pattern in which the outer stitch portions 148 and inner stitch portions 146 extend between respective pairs of consecutive piercing points 150, thereby simplifying such procedures by allowing the assembler to thread the secondary suture 156 through any piercing point 150 that is conveniently available during the assembly procedure.

[0225] According to some embodiments, the diameter of the aperture 142 is equal to or smaller than the diameter of the two primary sutures 144 such that each aperture 142 securely holds both primary sutures 144 when they extend therethrough. Because the secondary suture 156 expands outwardly the boundary of at least one of the primary sutures 144 in the penetration zone, alternative embodiments can include apertures 142 having a diameter equal to or smaller than the combined diameter of the two primary sutures 144 and the secondary suture 156.

[0226] Typically, threading sutures through the valve leaflets 132 involves using a needle or other sharp tool that can pierce the leaflets 132. However, the use of a needle or other sharp tool can lead to unintentional cuts, punctures, or other damage to the leaflets 132. Such damage can be difficult to foresee or predict by the manufacturer and difficult to detect by the end user when it occurs. The primary sutures 144 are threaded in an in-and-out fashion through the piercing points 150, which also serve as penetration sites through which the secondary sutures 156 are threaded. Thus, additional piercing or cutting of the leaflets can be avoided because the secondary sutures 156 are threaded through the primary sutures 144 and not directly into the leaflets. Advantageously, the proposed arrangement allows for the use of the secondary sutures 156 to attach the leaflets 132 to the struts of the frame without further puncturing the leaflet tissue, thereby improving the long-term durability of the leaflets.

[0227] A sewing pattern including a self-fastening construct 158 ​​for directly attaching the leaflets 132 to the struts 110 of the frame 106 according to any of the embodiments described above can be implemented for any type of prosthetic valve 100 (e.g., either a mechanically expandable valve 100′ or a balloon-expandable valve 100″). However, the advantages of the self-fastening construct 158 ​​are more pronounced with respect to a mechanically expandable valve 100′ of the type illustrated in FIG. 1A , which is shown to include two layers of intersecting struts 110′ (i.e., inner and outer struts) that intersect at a junction 116′ (e.g., via a pin or other hinge). A particular challenge with such a double-layered frame 106′ is that it is difficult to form suture knots at the pivot junction 116′ because relative movement between the intersecting struts 110′ can exert scissors-like shear forces, which can compromise the integrity of the sutures in such areas.

[0228] Unlike the bilayer frame 106' of a mechanically expandable valve (such as the valve 100' shown in FIG. 1A), the frame of a prosthetic valve formed by a unitary frame (such as the frame 106'' of the balloon-expandable valve 100'' shown in FIG. 1B) does not suffer from this problem in the same sense, and the sewing pattern utilized to directly connect the valve leaflets 132 to such a frame 106'' can include knots formed around the non-apex joints 116'' in a manner that maintains a firm attachment between the non-apex joints 116'' without necessarily utilizing a self-tightening construct.

[0229] 9A-9D , exemplary techniques for coupling leaflets 132 along their cusp end portions 134 to interconnected strut sections 111 at non-apex junctions 116 will now be discussed in accordance with the present teachings. The views illustrated in FIGS. 9A-9D are viewed from a bottom perspective of a section of a prosthetic valve (such as a section of prosthetic valve 100″). As used herein, strut section 111 refers to any section of a strut defined between two non-apex junctions 116 of a frame 106.

[0230] The frame 106" of the exemplary balloon-expandable valve 100" illustrated in FIG. 1B is shown to include a flat inflow apex 118" (as well as a flat outflow apex 120"). In some embodiments, the strut sections can be either relatively straight strut sections (e.g., such as strut section 111"b shown in FIG. 1B) extending between two non-apex junctions (e.g., non-apex junctions 116"b and 116"c) that are axially spaced from one another, and / or curved strut sections (e.g., such as strut section 111"a) extending between two non-apex junctions (e.g., non-apex junctions 116"a and 116"b) that are laterally spaced from one another but may be aligned at the same level between the inflow end 105" and the outflow end 103". In such embodiments, the peak of the curvature of the curved strut section may define an apex (such as, for example, inflow apex 118''a defined by curved strut section 111''a).

[0231] 9A-9B, each strut section 111 and each non-apex junction 116 is defined between opposite axial sides and opposite radial sides. For example, each strut section 111 is defined between a strut proximal side 190 facing the outflow end 103 and a strut distal side 191 facing the inflow end 105 (sides 190 and 191 are opposite axial sides of the strut section). Each strut section 111 is also defined between a strut inner side 192 facing the valve longitudinal axis 10 and a strut outer side 193 facing away from the axis 10 (sides 192 and 193 are opposite radial sides of the strut section). 5A-6, if the struts have a rectangular cross-sectional profile, then each of the sides 190, 191, 192, 193 may be defined by a corresponding planar surface of the strut. Nevertheless, as noted above, other cross-sectional shapes for the struts are contemplated, such that the sides do not necessarily include planar surfaces.

[0232] Each non-apex junction 116 is defined between a junction proximal side 194 facing the outflow end 103 and a junction distal side 195 facing the inflow end 105 (the sides 194 and 195 are opposite axial sides of the junction). Each non-apex junction 116 is similarly defined between a junction medial side 196 facing the valve longitudinal axis 10 and a junction lateral side 197 facing away from the axis 10 (the sides 196 and 197 are opposite radial sides of the junction). Each junction is also defined between two opposite lateral sides, i.e., a first junction lateral side 198 and a second junction lateral side 199. In the illustrated example, two strut sections 111 converge at each lateral side of the non-apex junction 116.

[0233] The primary suture 144 may be threaded through the cusp end portion 134 in an in-and-out pattern in the same manner described above in connection with Figure 4. In some embodiments, two primary sutures 144a and 144b are threaded in opposite directions through the piercing point 150 in a manner similar to that described above in connection with Figure 8. Thus, any reference to a primary suture described below in connection with Figures 9A-10 can refer to either a single primary suture configuration or two oppositely threaded sutures with equal force.

[0234] 9A-9B, cusp end portions 134 (through which primary sutures 144 are threaded in an in-and-out pattern) are approximated to strut section 111 such that cusp end portions 134 are preferably positioned radially inward at (optionally in contact with) strut inner sides 192. Secondary sutures 170 are sewn through primary sutures 144 and around strut section 111 in a manner that forms a series of loops or whip stitches 172 spaced from one another along the length of strut section 111. As will be described in more detail below, the secondary suture 170 can be similar to any embodiment of the secondary suture 156, except that the secondary suture 170 does not form a self-tightening construct 158, but rather wraps around at least one strut section 111 with a series of whip stitches and includes at least one joint locking knot 174 around at least one non-apex joint 116.

[0235] A whip stitch 172 is formed by threading a secondary suture 170 through the primary suture 144 at the piercing point 150, extending the secondary suture 170 around the strut section 111 and back towards the primary suture 144, and then threading the secondary suture 170 once again through the primary suture 144 at a successive piercing point 150 (at which point another whip stitch can be formed in a similar manner).

[0236] For example, whip stitch 172b shown in Figure 9B is formed by threading secondary suture 170 radially outward through primary suture 144 at pierce point 150 (shown in Figure 9B between loops 172a and 172b), extending it around strut segment 111 (in the illustrated example, radially outward over strut proximal side 190, then along strut outer side 193, which is hidden from view, and radially inward over strut distal side 195) and threading it back toward primary suture 144 (along strut inner side 192) to form the next whip stitch 172c in a similar manner. In some embodiments, as in the illustrated example, primary suture 144 is positioned proximal to or adjacent to strut proximal side 191.

[0237] Threading whip stitches 172 through successive pierce points 150 results in a series of angled whip stitches. An angled whip stitch may be defined as a stitch having at least one portion extending between opposite sides of a strut section 111 that is oriented at a non-perpendicular angle relative to a strut section axis, which is defined as tangent to the strut section 111 in the area of ​​the respective stitch.

[0238] In the example shown in Figures 9A-9B, the portion of the whip stitch 172b extending along the strut outer side 193 between the strut proximal side 190 and the strut distal side 191 (this portion is hidden from view in Figure 9B), the portion extending along the strut distal side 191 between the strut outer side 193 and the strut medial side 192, and the portion extending along the strut medial side 192 between the strut distal side 191 and the strut proximal side 190 (optionally at least partially over the leaflet inner surface 152) are oriented at a non-perpendicular angle to the strut section axis tangent to the strut 111a in the region of the whip stitch 172b.

[0239] Thus, each angled whip stitch 172 has a portion that extends over one axial side of the strut section 111 about which it is wrapped, which is closer to the junction 116 (at the end of the respective strut section) than the opposite portion that extends over the opposite axial side of the strut section. In the illustrated example, the portion of the whip stitch 172 that extends over the proximal side 190 of strut section 111a is closer to the junction 116b than the opposite portion that extends over the strut distal side 191. Alternatively, the opposite orientation of the whip stitch 172 could include the portion that extends over the strut distal side 191 being closer to such junction 116b than the portion that extends over the strut proximal side 190. A series of whip stitches 172 wrapped around a single strut section 111 defined between two junctions 116 will generally follow the same angled orientation.

[0240] Preferably, the diameter of the secondary suture 170 is sufficiently smaller than the diameter of the primary suture 144 so that threading the secondary suture 170 through the primary suture 144 does not tear or destroy the primary suture 144. The secondary to primary suture diameter ratio for the secondary suture 170 may be defined in the same manner as described above for the secondary suture 156. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.8. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.5. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.3.

[0241] As shown in FIG. 9B, these steps are repeated to form a series of angled whip stitches 172 (e.g., stitches 172a, 172b, 172c, etc.) up to a final whip stitch 172n, defined as the whip stitch closest to the non-apex junction 116 (junction 116b in FIG. 9B) at the end of the strut section 111, which extends to the final penetration point 150n, after which a secondary suture 170 is utilized to form a junction locking knot 174 over the corresponding non-apex junction 116.

[0242] The joint locking knot 174 includes a transition section 176, a first loop 178, and a second loop 180. The transition section 176 extends along one axial side of the joint 116 from the first joint lateral side 198 to the second joint lateral side 199. In the example illustrated in FIG. 9B , the secondary suture 170 extends from a final penetration point 150 n at the strut proximal side 190 to the strut distal side 191, adjacent the first lateral side 198 of the joint 116 b, over the outer side 193 of the strut section 111 a. The transition section 176 is then formed by extending the secondary suture 170 along the joint distal side 195 in an oblique direction (e.g., radially inward from the joint outer side 197 toward the joint inner side 196, and laterally from the first joint lateral side 198 to the second joint lateral side 199, etc.).

[0243] A first loop 178 is then formed by extending secondary suture 170 around strut section 111 extending from second lateral side 199 of junction 116b. Strut sections 111b and 111m are shown extending from second lateral side 199 of junction 116b. In the example illustrated in Figures 9B-9C, first loop 178 is formed by extending secondary suture 170 from transition section 176 around strut section 111m.

[0244] The second loop 180 is formed by threading the tail of the secondary suture 170 from the first loop 178 between the transition section 176 and the junction 116, and then looping it back so that it extends through the first loop 178. In the example illustrated in FIG. 9C , the secondary suture 170 (extending from the first loop 178) is, for example, passed axially (e.g., upward toward the outflow end 103) and then folded back on itself (e.g., distally / downward) and passed through the first loop 178. The tail of the secondary suture is then forcibly pulled, tightening both loops 178, 180 and locking the resulting knot 174.

[0245] The procedure may then be repeated by forming a series of whip stitches 172 attaching the leaflet 132 to the subsequent strut section 111 (e.g., strut section 111b, etc.) extending from the commissure 116, and by forming similar commissure-locking knots 174 above every respective commissure 116 along the path of the rounded cusp end portions 134. Advantageously, this type of sewing pattern expedites the valve assembly procedure because the knots 174 around the commissures 116 maintain a secure connection between the leaflet and the commissure during assembly.

[0246] Compared to conventional assembly procedures (during which the assembler is required to maintain tension on the suture while forming each subsequent stitch along the entire periphery of the frame), the joint locking knot 174 maintains a secure connection of all whip stitches 172 around the strut section 111 leading to each joint 116, freeing the assembler from the need to keep all previous stitches under tension, and even allowing the assembly procedure to continue at a later time without the risk of any of the previous loops of the knot coming loose.

[0247] The secure connection of the knot 174 keeps all of the whip stitches 172 along the strut section 111 connected to it similarly securely connected to the strut section 111, thereby reducing relative movement between the suture 170 and the strut section 111 under normal operation of the valve 100 after implantation.

[0248] Additionally, any joint locking knot 174 separates between series of whip stitches 172 around the strut section 111 extending from either side of the joint 116. Thus, the orientation of the angled whip stitches 172 formed following a joint locking knot 174 does not depend on the configuration of the whip stitches 172 leading to the knot 174, and indeed can have similar or different angular orientations, similar or different stitching densities, etc. This allows the assembler to switch the angular orientation of the angled whip stitches being sewn in any desired direction (which may be different for different strut portions 111 along the circumference of the valve 100) that may be convenient during the assembly procedure.

[0249] 10 shows an example of a portion of a leaflet assembly 130 sutured to a frame 106 (the view is from inside the valve). As shown, the procedure can be repeated to attach one or more other leaflets 132 to the strut section 111 and the coaptation 116, including forming a similar coaptation locking knot 174 around the coaptation 116 interconnecting two adjacent leaflets 132 (such as coaptation 116d aligned with the commissure 140 between leaflets 132a and 132b shown in FIG. 10).

[0250] In the illustrated view, the cusp end portions of leaflet 132a are sewn to strut sections 111a, 111b, and 111c, and the cusp end portions of leaflet 132b are sewn to strut sections 111d, 111e, and 111f. As shown, the angular orientation of whipstitches 172 around strut sections 111a, 111b, and 111c is generally similar (e.g., with their upper / proximal ends closer to junction 116d than their lower / distal ends). After tying a joint lock knot 174 around joint 116d, the orientation of the whip stitches 172 around strut sections 111d and 111e is flipped to generally the opposite direction, and after tying a joint lock knot 174 around joint 116f, the orientation of the whip stitches 172 around strut section 111f is switched again (to an orientation similar to that of the whip stitches looped over strut sections 111a-c), as shown. The ability to independently change the orientation of the whip stitches wrapped around each strut segment can facilitate the valve assembly process.

[0251] In some cases, it may be preferable to attach the leaflets 132 to the frame 106 utilizing secondary sutures 156 that do not pass through the leaflets 132 and / or the primary sutures 144. Figures 11A-11D show an exemplary technique for connecting the leaflets 132 to the strut sections 111 along their cusp end portions 134. The views shown in Figures 11A-11D are viewed from a bottom perspective of a section of the prosthetic valve (e.g., a section of prosthetic valve 100"), similar to the viewing angle of Figures 9A-9D.

[0252] The primary suture 144 may be threaded through the cusp end portion 134 in an in-and-out pattern in the same manner as described above in connection with FIG. 4, forming multiple running stitch portions, including inner stitch portions (hidden from view) that extend over the leaflet inner surface and outer stitch portions 148 (such as outer stitch portions 148a, 148b, and 148c shown in FIG. 11A) that extend over the leaflet outer surface 154 between piercing points 150. In some embodiments, two primary sutures 144a and 144b are threaded in opposite directions through piercing points 150 in a manner similar to that described above in connection with FIG. 8. Thus, any reference to a primary suture described below in connection with FIGS. 11A-11D can refer to either a single primary suture or two oppositely threaded sutures with equal force.

[0253] 11A, cusp end portions 134 (through which primary sutures 144 are threaded in an in-and-out pattern) are approximated by strut section 111 such that cusp end portions 134 are preferably positioned radially inward at (optionally in contact with) strut inner sides 192. Secondary sutures 170 are looped around outer stitch portions 148 of primary sutures 144 and around strut section 111 in a manner that forms a series of blind-through whip stitches 182 spaced from one another along the length of strut section 111. The secondary sutures 170 can be similar to any of the embodiments described above in connection with FIGS. 9A-9D, except that the secondary sutures in the embodiments shown in FIGS. 11A-11D are utilized to form blind whip stitches 182 instead of traditional whip stitches 172 that extend from one side of the leaflet to the other (e.g., from the leaflet inner surface 152 to its outer surface 154).

[0254] Unlike whip stitch 172, non-penetrating whip stitch 182 does not thread primary suture 144 at piercing point 150 or any other area of ​​primary suture 144 and does not penetrate the valve leaflet from one side to the other. Non-penetrating whip stitch 182 is formed by looping secondary suture 170 around strut section 111, thereby forming strut wrap section 184, and then looping secondary suture around outer stitch portion 148, thereby forming primary suture wrap section 186. This can be repeated to form a series of subsequent non-penetrating whip stitches 182 in a similar manner along strut section 111.

[0255] For example, Figure 11A shows two blind-through whip stitches 182a and 182b, each including a corresponding strut wrap section 184 and a corresponding primary suture wrap section 186. A subsequent blind-through whip stitch 182c is formed by looping the tail of secondary suture 170 extending from primary suture wrap section 186b (which is looped around outer stitch portion 148b) around strut section 111 and back toward the subsequent stitch portion 148c of primary suture 144, as shown in Figure 11B.

[0256] In the example shown in Figures 11A-11B, the strut wrap section 184c is formed by extending the secondary suture 170 across one radial side of the strut section (e.g., strut outer side 193) from one axial side of the strut to the opposite axial side (e.g., from strut proximal side 190 to strut distal side 191), folding it back over the corresponding axial side of the strut (e.g., over strut distal side 191), and extending it across the opposite radial side (e.g., strut inner side 192) back toward the primary suture 144 (e.g., from strut distal side 191 to strut proximal side 190).

[0257] 11B, the secondary suture 170 is then passed under the continuous outer stitch portion 148c between the outer stitch portion and the leaflet 132 (i.e., between the outer stitch portion 148 and the leaflet inner surface 152). As shown in FIG. 11C, the secondary suture 170 is then folded back over the outer stitch portion 148c, thereby forming a primary suture wrap section 186c. The suture may then be passed across the strut section 111 (e.g., across the strut outer side 193 toward the strut distal side 191 in the example shown in FIG. 11C), repeating these steps to form a subsequent blind-through whip stitch 182 (e.g., blind-through whip stitch 182d, etc.).

[0258] As shown in FIG. 11D, this procedure may be repeated up to a final non-through whip stitch 182n, defined as the whip stitch closest to the non-apex joint 116 at the end of the strut section 111, and the secondary suture 170 may be utilized to form the joint locking knot 174 according to the same steps described above in connection with FIGS. 9A-9D, except that the transition zone 176 of the joint locking knot 174 extends from the final primary suture wrap section 186n of the final non-through whip stitch 182n instead of extending from the final piercing point 150n.

[0259] 12A-12D show another exemplary technique for connecting the leaflet 132 along its cusp end portion 134 to the strut section 111 via a series of blind-through whip stitches 182, which may be identical to the technique described in connection with FIGS. 11A-11D , except that instead of passing the secondary suture 170 extending from the strut wrap section 184 under the outer stitch portion 148 and then folding it back over the outer stitch portion 148 to form the primary suture wrap section 186 (as shown in FIGS. 11B-11C ), the secondary suture 170 is passed over the outer stitch portion 148 (see FIG. 12B ) and then folded back under it (i.e., between the outer stitch portion 148 and the leaflet inner surface 152). All other steps and embodiments may be similar to those described above in connection with FIGS. 11A-11D and will not be described further for the sake of brevity.

[0260] 13 shows another sewing configuration similar to that shown in FIGS. 12A-12D, except that two blind-through whip stitches 182 pass through each outer stitch portion 148. In the example shown, the blind-through whip stitch 182a′ includes a strut wrap section 184a′ that is looped around the strut section 111 and a primary suture wrap section 186a′ that extends from the strut wrap section 184a′ and is looped around the outer stitch portion 148a. The secondary suture 170 then extends to form the strut wrap section 184a′ of the blind-through whip stitch 182a″ and the primary suture wrap section 186a′ that is looped around the same outer stitch portion 148a.

[0261] Secondary suture 170 is then extended to form subsequent blind-through whip stitches 182b' and 182b" in a similar manner, with their primary suture wrap sections 186b' and 186b" looped around outer stitch portion 148b. Although two blind-through whip stitches 182 passing through a single outer stitch portion 148 are illustrated in FIG. 13, it should be understood that any other number of blind-through whip stitches 182 can pass through any single outer stitch portion 148 in a similar manner.

[0262] 14 shows yet another stitching configuration similar to that shown in FIGS. 12A-12D except that each non-through whip stitch 182 also includes a strut loop section 185 extending from a respective primary suture wrap section 186, with strut loop section 185 looped only over strut section 111. In the example shown, non-through whip stitch 182a includes strut wrap section 184a, primary suture wrap section 186a, and strut loop section 185a, with strut wrap section 184a looped around strut section 111, primary suture wrap section 186a extending from strut wrap section 184a and looped around outer stitch portion 148a, and strut loop section 185a extending from primary suture wrap section 186a and looped again around strut section 111.

[0263] In the particular illustrated example, strut loop section 185a is formed by extending secondary suture 170 from primary suture wrap section 186a across one radial side of the strut section (such as, for example, strut outer side 193), around strut distal side 191, over the other radial side (such as, for example, strut inner side 192), toward and over strut proximal side 190. The secondary suture is then extended to form strut wrap section 184b, primary suture wrap section 186b, and strut loop section 185b, together forming a subsequent blind-through whip stitch 182b in a similar manner. In the example, a single strut loop section 185 is shown, but it should be understood that the blind-through whip stitch 182 can similarly include multiple single strut loop sections 185 looped one after the other around the strut section 111 before forming a subsequent blind-through whip stitch 182.

[0264] 11A-14 , showing the primary suture wrap section 186 looped around the outer stitch portion 148, is non-binding, and it should be understood that any primary suture wrap section 186 can be looped around any running stitch portion (including around the inner stitch portion 146 of the primary suture 144). In some embodiments, the cusp end portion 134 can be folded back on itself so that the cusp edge 135 rests on the outward-facing leaflet outer surface 152, with the outer stitch portion 148 hidden and the inner stitch portion 146 facing the strut section 111. In such embodiments, a blind-through whip stitch can be formed in the same manner as described above, except that the secondary suture is looped around the inner stitch portion 146 instead of around the outer stitch portion.

[0265] It should be understood that various sewing configurations can be combined to attach one or more leaflets 132 to strut sections 111 of the same prosthetic valve 100. For example, attaching a leaflet 132 along its rounded cusp end portion 134 to one or more strut sections 111 can include a combination of one or more single blind-through whip stitches 182 passing through corresponding running stitch portions (as illustrated in FIGS. 12A-12D), one or more double blind-through whip stitches 182 passing through corresponding single running stitch portions (as illustrated in FIG. 13), and / or one or more single blind-through whip stitches 182 looped twice around the strut section 111 (as illustrated in FIG. 14). Single or multiple pattern configurations can be implemented along the same strut section 111 or around different strut sections of the same valve.

[0266] Attaching the leaflets 132 to the frame 106 (more specifically, to the strut sections 111 of the frame 106) with non-penetrating whip stitches 182 can advantageously improve the long-term durability of the leaflets and their attachment to the frame along the scalloped line due to reduced damage to the leaflet material resulting from the fact that the secondary sutures 170 do not need to penetrate tissue material.

[0267] Although the non-penetrating whip stitch 182 (with or without the joint locking knot 174) is described and illustrated above with respect to the attachment of the valve leaflets 132 to the frame 106, such attachment configurations may likewise be utilized for the attachment of other soft components of the valve 100 to the frame 106 (e.g., the skirt 123, which may include either an inner skirt (not shown) or an outer skirt 124).

[0268] FIG. 15 illustrates a prosthetic valve 100 with an outer skirt 124, according to some embodiments. The prosthetic valve can be similar in all respects to the prosthetic valve 100″ described in connection with FIG. 1B and, for the sake of brevity, will not be described further. The skirt 123 (such as the outer skirt 124 shown in FIG. 15 ) extends between a skirt proximal end 129 and a skirt distal end 128 and defines a skirt inner surface 125 facing (and at least partially in contact with) the frame 106 and an opposing skirt outer surface 126 facing away from the frame (toward the natural anatomy when implanted in a patient's body).

[0269] In some embodiments, as further shown in Figure 15, the proximal end of the outer skirt follows a zigzag pattern that corresponds to the zigzag pattern of the strut sections 111 to which it may be sewn. In the particular exemplary embodiment illustrated in Figure 15, the skirt distal end 128 is substantially straight (e.g., straightened when the skirt is flattened), meaning that it is held at the same axial level and disposed circumferentially about the inflow end portion 104 of the valve 100.

[0270] In some embodiments, the primary suture(s) 144 are sewn along the portion of the skirt 123 that is aligned with the strut section 111 of the frame 106 in an in-and-out pattern, and the secondary suture(s) 170 form a plurality of blind whip stitches 182 to connect the skirt 123 to the strut section 111 of the frame 106.

[0271] The primary suture 144 may be sewn mutatis mutandis through the skirt 123 in an in-and-out pattern according to any of the embodiments disclosed herein. Similarly, any type of blind whip stitch 182 disclosed above with respect to the attachment of the leaflets 132 to the struts 111 may likewise be adapted to attach the skirt 123 to the struts 111 in the same manner, mutatis mutandis.

[0272] FIG. 16 shows a partial view of the outer skirt 124 connected to the struts 111 of the frame 106 of the valve 100 shown in FIG. 15 from an internal valve viewing angle. The leaflet assembly 130 is omitted from the view in FIG. 16 for simplicity. In the exemplary embodiment shown, the primary sutures 144 are sewn in an in-and-out pattern along the skirt proximal end 129, e.g., tracing its zigzag shape. In the case of the outer skirt 124, the primary sutures 144 can define a series of running stitch portions including an inner stitch portion 146 and an outer skirt portion 148, where the inner stitch portion 146 is disposed on the skirt inner surface 125 and the outer skirt portion 148 is disposed on the skirt outer surface 126. A plurality of non-penetrating whip stitches 182 are then looped around the strut section 111 through the strut wrap section 184 and also around the running stitch portion of the primary suture 144 (e.g., over and between the inner stitch portion 146 and the skirt inner surface 125).

[0273] A particular embodiment of a blind whip stitch 182 similar to that described in connection with Figures 12A-12D is illustrated in Figure 16, for example, along strut sections 111m, 111n, 111o, and 111p, although it should be understood that the skirt may be sewn to the corresponding strut section 111 by implementing any of the stitching patterns and methods described above in connection with Figures 11A-14, mutatis mutandis.

[0274] In some embodiments, joint locking knots 174 are also used to attach skirts 123 (such as outer skirts 124) to joints 116 disposed between strut sections 111 to which the skirts are sutured via blind-through whip stitches 182, such as joint locking knots 174m, 174n, 174o, 174p, and 174q formed on respective joints 116m, 116n, 116o, 116p, and 116q in the illustrated example. The configuration and method of forming such joint locking knots 174 are similar to those described above with respect to attachment of leaflets 132 to joints 116, mutatis mutandis.

[0275] In some embodiments, the skirt 123 (e.g., the outer skirt 124, etc.) is connected to additional joints 116 (which are not necessarily disposed between the strut sections 111 around which the blind-through whip stitches 182 extend) via additional knots, which are not necessarily joint lock knots 172 but may also be implemented as other knots known in the art, for example, as shown schematically in FIG. 16 for knots 166r, 166s, and 166t around the respective joints 116r, 116s, and 116t.

[0276] FIG. 17 shows another valve 100 including an outer skirt 124 that may be similar to the valve and skirt of FIG. 15, except that the skirt distal end 128 is not straight, but rather follows the shape of the strut section 111 along the inflow end portion 104 of the valve (which may be wavy or arc-shaped, as shown in FIG. 17, or may be otherwise zigzag or otherwise shaped to follow other paths defined by the distal strut sections of the valve).

[0277] Figure 18 shows a partial view of the outer skirt 124 connected to the struts 111 of the frame 106 of the valve 100 shown in Figure 17 from a valve-base-internal viewing angle. The leaflet assembly 130 has been omitted from the view in Figure 18 for simplicity. In the exemplary embodiment shown, primary sutures 144 are sewn in an in-and-out pattern along the skirt distal end 128, e.g., following its contoured shape. This, in addition to the primary sutures 144, could be sewn along the skirt proximal end 129, which would be implemented in the same manner as described above.

[0278] A plurality of blind-through whip stitches 182 are then looped around strut section 111 (at inflow end portion 104) by a series of strut wrap sections 184 and around the running stitch portion of primary suture 144 (e.g., over and between inner stitch portion 146 and skirt inner surface 125). A particular embodiment of blind-through whip stitches 182 similar to those described in connection with FIGS. 12A-12D is illustrated in FIG. 18, for example, along strut sections 111u and 111w, although it should be understood that the skirt may be sewn to the corresponding strut section 111 by implementing any of the stitching patterns and methods described above in connection with FIGS. 11A-14, mutatis mutandis.

[0279] In some embodiments, the joint locking knots 174 are similarly used to attach the outer skirt 124 to the joints 116 along the inflow end portion 104 according to the same configurations and methods described above for attaching the leaflets 132 to the joints 116, mutatis mutandis, such as joint locking knots 174r, 174s, and 174t formed around the respective joints 116r, 116s, and 116t in the illustrated example.

[0280] In some embodiments, the skirt 123 (e.g., outer skirt 124, etc.) is attached to additional strut sections 111 disposed between the skirt proximal end 129 and the skirt distal end 128 via blind-through whip stitches 182 in the same manner, and in accordance with all optional embodiments described above. For example, primary suture(s) 144 may be sewn in an in-and-out pattern along regions of the skirt that are aligned with strut sections 111 disposed between the skirt proximal end 129 and the skirt distal end 128 (when the skirt is attached to the frame), as implemented in accordance with any embodiment of sewing such primary sutures 144 described above. A series of blind whip stitches 182 (implemented according to any of the embodiments described above with respect to Figures 11A-14) may be utilized to attach the skirt to the corresponding strut section 111, as shown in Figure 18, for example, along strut sections 111r, 111s, 111t, and 111v.

[0281] In some embodiments, the skirt 123 (e.g., the outer skirt 124, etc.) is attached to an additional joint 116 disposed between the skirt proximal end 129 and the skirt distal end 128 via a joint lock knot 174 in the same manner and in accordance with all optional embodiments described above.

[0282] Some valves are provided with an inner skirt (not shown) disposed around the inner surface of the frame. Although an outer skirt 124 is illustrated throughout Figures 15-18 to demonstrate various configurations for its attachment to the frame, it should be understood that the same embodiments described above with respect to outer skirt attachment can be implemented mutatis mutandis in a similar manner with respect to attachment of the inner skirt to the frame.

[0283] In some embodiments, the joint lock knot 174 may be utilized to attach the skirt 123 (including either the inner skirt or the outer skirt) to the joint 116 along either the skirt proximal end 129 or the skirt distal end 128, and / or to the joint 116 disposed between the skirt proximal end 129 and the skirt distal end 128 (when the skirt is attached to the frame) without the use of a blind whip stitch 182 around the strut section 111.

[0284] For example, the skirt may be sewn to corresponding strut sections 111 along either the skirt proximal end 129 or the skirt distal end 128, and / or to strut sections 111 disposed between the skirt proximal end 129 and the skirt distal end 128 (when the skirt is attached to the frame), mutatis mutandis, in the same manner and according to the similar method described above in Figures 10A-11 with respect to the attachment of the valve leaflets 132 to the frame 106, via a series of whip stitches 172 which may pass through the primary suture 144 with joint locking knots 174 formed around the joints 116 disposed between such strut sections 111.

[0285] Additional Examples of the Disclosed Technology In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that one feature of an embodiment in isolation, or two or more features of that embodiment in combination, and optionally two or more features of that embodiment in combination with one or more features of one or more additional embodiments, are also additional embodiments that fall within the disclosure of the present application.

[0286] Example 1. An artificial valve, comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of intersecting struts; a valve leaflet assembly including a plurality of leaflets mounted within a frame and configured to regulate flow through the prosthetic valve, each leaflet including a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely directed tabs separating the cusp edge and the free edge; Including, each cusp end portion is coupled to at least one strut via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portion at a piercing point, the secondary suture being threaded through the primary suture and around at least one section of the at least one strut, the secondary suture including a plurality of self-tightening constructs, each self-tightening construct including at least one loop configured to contract around a strut under tension.

[0287] Example 2. The prosthetic valve described in any example herein, particularly Example 1, wherein at least one loop of each self-tightening construct comprises two loops.

[0288] Example 3. The prosthetic valve as described in any example herein, particularly as described in Example 1 or 2, wherein each self-tightening construct further includes a U-shaped section extending partially between at least one loop and a strut.

[0289] Example 4. A prosthetic valve as described in any example herein, particularly any one of Examples 1 to 3, wherein the leaflets include a leaflet inner surface and a leaflet outer surface, and the primary suture includes a plurality of inner stitch portions disposed along the leaflet inner surface and a plurality of outer stitch portions disposed along the leaflet outer surface, each inner stitch portion and each outer stitch portion being defined between respective penetration points.

[0290] Example 5. A prosthetic valve as described in any example herein, particularly as described in Example 4, wherein a self-tightening construct is defined between two piercing points defining at least one outer stitch portion therebetween.

[0291] Example 6. The prosthetic valve as described in any example herein, particularly as described in Example 4 or 5, wherein the secondary suture further comprises a plurality of suture tension portions extending over the leaflet inner surfaces.

[0292] Example 7. The prosthetic valve described in any example herein, particularly Example 6, wherein at least one of the suture tensioning portions extends over two or more inner or outer stitching portions.

[0293] Example 8. The prosthetic valve as described in any example herein, particularly as described in Example 6 or 7, wherein the suture tensioning portion is pressed against the at least one primary suture portion.

[0294] Example 9. The prosthetic valve described in any example herein, particularly any one of Examples 1 to 8, wherein the diameter of the secondary sutures is smaller than the diameter of the primary sutures.

[0295] Example 10. The prosthetic valve described in any example herein, especially Example 9, wherein the diameter ratio of the secondary sutures to the primary sutures is equal to or less than 0.8.

[0296] Example 11. The prosthetic valve described in any example herein, especially Example 9, wherein the diameter ratio of the secondary sutures to the primary sutures is equal to or less than 0.5.

[0297] Example 12. The prosthetic valve described in any example herein, especially Example 9, wherein the diameter ratio of the secondary sutures to the primary sutures is equal to or less than 0.3.

[0298] Example 13. The prosthetic valve as described in any example herein, particularly any one of Examples 1 to 12, wherein the cusp end portion of each leaflet includes a series of pre-formed apertures.

[0299] Example 14. A prosthetic valve as described in any example herein, particularly as described in Example 13, wherein the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0300] Example 15. The prosthetic valve of any example herein, particularly Example 13 or 14, wherein the apertures are evenly spaced from one another.

[0301] Example 16. The prosthetic valve described in any example herein, particularly any one of Examples 13 to 15, wherein the diameter of the aperture is equal to or less than the diameter of the primary suture.

[0302] Example 17. The prosthetic valve described in any example herein, particularly any one of Examples 13 to 15, wherein the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0303] Example 18. The prosthetic valve described in any example herein, particularly any one of Examples 1 to 17, wherein the secondary suture is threaded through all consecutive penetration points.

[0304] Example 19. The prosthetic valve as described in any example herein, particularly any one of Examples 1 to 18, wherein the at least one primary suture comprises two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same penetration point.

[0305] Example 20. The prosthetic valve described in any example herein, particularly any one of Examples 13 to 15, wherein the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0306] Example 21. The prosthetic valve described in any example herein, particularly Example 20, wherein the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0307] Example 22. A prosthetic valve as described in any example herein, particularly any one of Examples 1 to 21, wherein at least one primary suture tracks the curvature of at least one cusp edge.

[0308] Example 23. The prosthetic valve of any example herein, particularly any one of Examples 1 to 22, wherein the primary suture comprises a multifilament suture.

[0309] Example 24. The prosthetic valve as described in any example herein, particularly any one of Examples 1 to 23, wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0310] Example 25. The prosthetic valve described in any example herein, particularly any one of Examples 1 to 24, wherein the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the valve leaflets and the struts to which they are attached.

[0311] Example 26. A method for assembling a prosthetic valve, comprising: passing a primary suture in an in-and-out pattern through the cusp end portions of the valve leaflets; approximating the cusp end portion with the primary suture threaded therethrough to at least one strut of a prosthetic valve frame; sewing a secondary suture through the primary suture and around at least one strut in a manner to form a plurality of self-tightening constructs, each self-tightening construct formed to include at least one loop configured to contract around the strut under tension; A method comprising:

[0312] Example 27. The method described in any example herein, particularly Example 26, wherein the step of sewing a secondary suture includes threading the secondary suture radially outward through the primary suture at the piercing point, thereby forming at least one loop around at least one strut.

[0313] Example 28. The method described in any example herein, particularly Example 27, wherein the step of sewing the secondary suture includes re-looping the secondary suture around at least one strut after forming a first loop, thereby forming two loops for each self-tightening construct.

[0314] Example 29. The method described in any example herein, particularly any one of Examples 26 to 28, wherein the step of sewing a secondary suture includes passing the secondary suture under at least one loop between the at least one loop and at least one strut to form a U-shaped section.

[0315] Example 30. The method of any example herein, particularly any one of Examples 26 to 29, further comprising extending a secondary suture over the leaflet inner surface, and then threading the secondary suture once more radially outwardly through the primary suture, thereby forming at least one suture tension portion extending over the leaflet inner surface.

[0316] Example 31. The method of any example herein, particularly any one of Examples 26 to 30, wherein the cusp end portion of each leaflet includes a series of preformed apertures, and wherein threading the primary sutures includes threading the primary sutures in an in-and-out pattern through the series of preformed apertures.

[0317] Example 32. An artificial valve, comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of strut sections intersecting at joints; a valve leaflet assembly including a plurality of leaflets mounted within a frame and configured to regulate flow through the prosthetic valve, each leaflet including a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely directed tabs separating the cusp edge and the free edge; Including, Each joint is defined between two opposite axial sides including a joint proximal side and a joint distal side; between two opposite radial sides including a joint medial side and a joint lateral side; and between two opposite lateral sides including a first joint lateral side and a second joint lateral side; Each cusp end portion is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portion at a piercing point, and the secondary suture being threaded through the primary suture and wrapped around the strut section in a series of whip stitches spaced from one another along the length of the strut section; The cusp end portion is further coupled to at least one junction at the end of the strut section via a junction locking knot formed by a second suture, the junction locking knot being configured to maintain tension on a plurality of whip stitches wrapped around a corresponding strut section leading to the lateral side of the first junction, the prosthetic valve.

[0318] Example 33. Each joint lock knot is a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from the second junction lateral side; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 32。 The prosthetic valve of any embodiment herein, particularly embodiment 32.

[0319] Example 34. A prosthetic valve as described in any example herein, particularly as described in Example 33, wherein the transition section extends in an oblique direction from one radial side of the joint to the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0320] Example 35 The prosthetic valve described in any example herein, particularly Example 33 or 34, wherein both the first loop and the second loop are tightly tensioned around the coaptation.

[0321] Example 36. A prosthetic valve as described in any example herein, particularly any one of Examples 32 to 35, wherein each of the plurality of whip stitches wrapped around a single strut section is an angled whip stitch oriented in the same direction along the length of the corresponding strut section.

[0322] Example 37. A prosthetic valve as described in any example herein, particularly as described in Example 36, wherein the cusp end portion is sewn to at least two strut sections extending from both lateral sides of the selected junction via a plurality of whip stitches wrapped around each of the respective strut sections and a junction locking knot around the junction positioned therebetween, and the plurality of whip stitches around one of the strut sections are angled in an opposite direction to the plurality of whip stitches wrapped around the other strut section.

[0323] Example 38. The prosthetic valve described in any example herein, particularly any one of Examples 32 to 37, wherein the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0324] Example 39. The prosthetic valve described in any example herein, especially Example 38, wherein the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0325] Example 40. The prosthetic valve described in any example herein, especially Example 38, wherein the diameter ratio of the secondary suture to the primary suture is less than or equal to 0.5.

[0326] Example 41. The prosthetic valve described in any example herein, especially Example 38, wherein the diameter ratio of the secondary suture to the primary suture is less than or equal to 0.3.

[0327] Example 42. The prosthetic valve as described in any example herein, particularly any one of Examples 32 to 41, wherein the cusp end portion of each leaflet includes a series of pre-formed apertures.

[0328] Example 43. A prosthetic valve as described in any example herein, particularly as described in Example 42, wherein the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0329] Example 44 The prosthetic valve of any example herein, particularly Example 42 or 43, wherein the apertures are evenly spaced from one another.

[0330] Example 45. The prosthetic valve described in any example herein, particularly any one of Examples 42 to 44, wherein the diameter of the aperture is equal to or smaller than the diameter of the primary suture.

[0331] Example 46. The prosthetic valve described in any example herein, particularly any one of Examples 42 to 44, wherein the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0332] Example 47. The prosthetic valve as described in any example herein, particularly any one of Examples 32 to 46, wherein the at least one primary suture comprises two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same penetration point.

[0333] Example 48. A prosthetic valve as described in any example herein, particularly any one of Examples 42 to 44, wherein the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0334] Example 49. The prosthetic valve described in any example herein, particularly Example 48, wherein the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0335] Example 50. A prosthetic valve as described in any example herein, particularly any one of Examples 32 to 49, wherein at least one primary suture tracks the curvature of at least one cusp edge.

[0336] Example 51 The prosthetic valve of any example herein, particularly any one of Examples 32 to 50, wherein the primary suture comprises a multifilament suture.

[0337] Example 52 The prosthetic valve as described in any example herein, particularly any one of Examples 32 to 51, wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0338] Example 53. The prosthetic valve as described in any example herein, particularly any one of Examples 32 to 52, wherein the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the leaflets and the strut sections and coaptations to which they are attached.

[0339] Example 54. A method for assembling an artificial valve, comprising: passing a primary suture in an in-and-out pattern through the cusp end portions of the valve leaflets; approximating the cusp end portion with the primary suture threaded therethrough to at least one strut section of a prosthetic valve frame; sewing a secondary suture through the primary suture and around at least one strut section in a manner to form a plurality of whip stitches wrapped around the strut section up to a final whip stitch; forming a joint locking knot extending from the final whip stitch around a joint at each end of a corresponding strut section, the joint locking knot configured to maintain tension on the plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint; A method comprising:

[0340] Example 55. The method described in any example herein, particularly Example 54, wherein the step of forming the joint locking knot includes extending a secondary suture from a final whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0341] Example 56. The method described in any example herein, particularly Example 55, wherein the step of forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0342] Example 57. The method described in any example herein, particularly Example 56, wherein the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself, and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0343] Example 58. The method described in any example herein, particularly Example 57, wherein the step of forming a joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0344] Example 59. The method described in any example herein, particularly any one of Examples 55 to 58, wherein the step of forming the transition section includes extending the secondary suture in an oblique direction from one radial side of the joint toward an opposite radial side of the joint, and from one lateral side of the joint to an opposite lateral side of the joint.

[0345] Example 60. The method of any example herein, particularly any one of Examples 54 to 59, wherein forming a plurality of whip stitches around any single strut section includes forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0346] Example 61. The method described in any example herein, particularly Example 60, wherein the step of sewing a secondary suture around at least one strut section includes sewing around at least two strut sections separated from one another by a reciprocal joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0347] Example 62. The method described in any example herein, particularly any one of Examples 54 to 61, wherein the cusp end portion of each leaflet includes a series of preformed apertures, and the step of threading the primary sutures includes threading the primary sutures in an in-and-out pattern through the series of preformed apertures.

[0348] Example 63. An artificial valve, comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of strut sections intersecting at joints; a valve leaflet assembly including a plurality of leaflets mounted within a frame and configured to regulate flow through the prosthetic valve, each leaflet including a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely directed tabs separating the cusp edge and the free edge; Including, each cusp end portion is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portions, the secondary sutures forming a series of non-penetrating whip stitches spaced from one another along the length of the strut section, each non-penetrating whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section being looped around the strut section, and the primary suture wrap section extending from the strut wrap section and looped around the primary suture and passing between the primary suture and the valve leaflet.

[0349] Example 64. A prosthetic valve as described in any example herein, particularly as described in Example 63, wherein the primary suture defines a series of running stitch portions, each primary suture wrap section being looped around a corresponding running stitch portion and extending between the running stitch portion and the rounded cusp end portion.

[0350] Example 65 The prosthetic valve described in any example herein, particularly Example 63 or 64, wherein the secondary suture does not penetrate the valve leaflets.

[0351] Example 66 The prosthetic valve described in any example herein, particularly any one of Examples 63 to 65, wherein the secondary suture does not pass through the primary suture.

[0352] Example 67. A prosthetic valve as described in any example herein, in particular any one of Examples 63 to 66, wherein each junction is defined between two opposite axial sides including a proximal junction side and a distal junction side; between two opposite radial sides including a medial junction side and an lateral junction side, and between two opposite lateral sides including a first lateral junction side and a second lateral junction side, and the cusp end portion is further connected to at least one junction at the end of the strut section via a junction locking knot formed by a second suture, and the junction locking knot is configured to maintain tension on a plurality of non-penetrating whip stitches wrapped around the corresponding strut section leading to the first lateral junction side.

[0353] Example 68. Each joint lock knot is a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from the second junction lateral side; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 67. The prosthetic valve of any embodiment herein, particularly as described in Example 67, including:

[0354] Example 69. An artificial valve as described in any example herein, particularly as described in Example 68, wherein the transition section extends in an oblique direction from one radial side of the joint to the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0355] Example 70 The prosthetic valve described in any example herein, particularly Example 68 or 69, wherein both the first loop and the second loop are tightly tensioned around the coaptation.

[0356] Example 71. A prosthetic valve as described in any example herein, particularly any one of Examples 67 to 70, wherein each of the plurality of non-penetrating whip stitches wrapped around a single strut section is an angled non-penetrating whip stitch oriented in the same direction along the length of the corresponding strut section.

[0357] Example 72. A prosthetic valve as described in any example herein, particularly as described in Example 71, wherein the cusp end portion is sewn to at least two strut sections extending from both lateral sides of the selected junction via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a junction locking knot around the junction positioned therebetween, and the plurality of non-penetrating whip stitches around one of the strut sections are angled in an opposite direction to the plurality of non-penetrating whip stitches wrapped around the other strut section.

[0358] Example 73. The prosthetic valve as described in any example herein, particularly any one of Examples 63 to 72, wherein the at least one primary suture comprises two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern.

[0359] Example 74. A prosthetic valve as described in any example herein, particularly any one of Examples 63 to 73, wherein at least one primary suture tracks the curvature of at least one cusp edge.

[0360] Example 75 The prosthetic valve as described in any example herein, particularly any one of Examples 63 to 74, wherein the primary suture comprises a multifilament suture.

[0361] Example 76 The prosthetic valve as described in any example herein, particularly any one of Examples 63 to 75, wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0362] Example 77. The prosthetic valve described in any example herein, particularly any one of Examples 63 to 76, wherein the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the valve leaflets and the strut sections to which they are attached.

[0363] Example 78. A method for assembling a prosthetic valve, comprising: passing a primary suture in an in-and-out pattern through the cusp end portions of the valve leaflets; approximating the cusp end portion with the primary suture threaded therethrough to at least one strut section of a prosthetic valve frame; looping a secondary suture around at least one strut section and around the primary suture in a manner to form a plurality of blind-through whip stitches wrapped around the strut section up to a final blind-through whip stitch, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section, passing between the primary suture and the leaflet, and looped around the primary suture; A method comprising:

[0364] Example 79. The method described in any example herein, particularly Example 78, wherein the step of forming each blind whip stitch includes the step of extending a secondary suture across one radial side of the strut section, folding it back over the axial side of the strut section, and extending it back across the opposite radial side of the strut section, thereby forming a strut wrap section.

[0365] Example 80. The method described in any example herein, particularly Example 79, wherein the step of forming each blind whip stitch further comprises passing a secondary suture between the running stitch portion of the primary suture and the cusp end portion of the valve leaflet and folding it back over the running stitch portion to form a primary suture wrapped section.

[0366] Example 81. The method described in any example herein, particularly Example 79, wherein the step of forming each blind whip stitch further comprises passing a secondary suture over the running stitch portion of the primary suture and looping it back over the running stitch portion and between the running stitch portion and the cusp end portion of the valve leaflet, thereby forming a primary suture wrapped section.

[0367] Example 82 The method described in any example herein, especially Example 80 or 81, wherein the running stitch portion is an outer stitch portion of the primary suture.

[0368] Example 83. The method described in any example herein, particularly any one of Examples 78 to 82, further comprising the step of forming a joint locking knot extending from the final non-penetrating whip stitch around the joint at each end of the corresponding strut section, the joint locking knot being configured to maintain tension on the plurality of non-penetrating whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0369] Example 84. The method described in any example herein, particularly Example 83, wherein the step of forming the joint locking knot includes extending a secondary suture from a final blind-through whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0370] Example 85. The method described in any example herein, particularly Example 84, wherein the step of forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0371] Example 86. The method described in any example herein, particularly Example 85, wherein the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself, and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0372] Example 87. The method described in any example herein, particularly Example 86, wherein the step of forming a joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0373] Example 88. A method as described in any example herein, particularly any one of Examples 84 to 87, wherein the step of forming the transition section includes extending the secondary suture in an oblique direction from one radial side of the joint toward an opposite radial side of the joint, and from one lateral side of the joint to an opposite lateral side of the joint.

[0374] Example 89. The method described in any example herein, particularly any one of Examples 83 to 88, wherein forming multiple whip stitches around any single strut section includes forming multiple angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0375] Example 90. The method of any example herein, particularly Example 89, wherein the step of forming a plurality of whip stitches around at least one strut section includes forming a plurality of whip stitches around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0376] Example 91. An artificial valve, a frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of strut sections intersecting at joints; a valve leaflet assembly including a plurality of leaflets mounted within a frame and configured to regulate flow through the prosthetic valve; a skirt disposed about the frame, the skirt including a skirt proximal end and a skirt distal end; Including, Each joint is defined between two opposite axial sides including a joint proximal side and a joint distal side; between two opposite radial sides including a joint medial side and a joint lateral side; and between two opposite lateral sides including a first joint lateral side and a second joint lateral side; the skirt proximal end is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the skirt proximal end at a piercing point, and the secondary suture being threaded through the primary suture and wrapped around the strut section in a series of whip stitches spaced from one another along the length of the strut section; The proximal end of the skirt is further coupled to at least one joint at the end of the strut section via a joint locking knot formed by a second suture, the joint locking knot being configured to maintain tension on a plurality of whip stitches wrapped around a corresponding strut section leading to the lateral side of the first joint, prosthetic valve.

[0377] Example 92. The prosthetic valve described in any example herein, particularly Example 91, wherein the proximal end of the skirt follows a zigzag pattern.

[0378] Example 93. The prosthetic valve as described in any example herein, particularly as described in Example 92, wherein at least one primary suture tracks a zigzag pattern in the proximal end of the skirt.

[0379] Example 94. Each joint lock knot is a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from the second junction lateral side; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 93. The prosthetic valve of any embodiment herein, in particular any one of embodiments 91 to 93, including:

[0380] Example 95. An artificial valve as described in any example herein, particularly as described in Example 94, wherein the transition section extends in an oblique direction from one radial side of the joint to the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0381] Example 96 The prosthetic valve described in any example herein, particularly Example 94 or 95, wherein both the first loop and the second loop are tightly tensioned around the coaptation.

[0382] Example 97. A prosthetic valve as described in any example herein, particularly any one of Examples 91 to 96, wherein each of the plurality of whip stitches wrapped around a single strut section is an angled whip stitch oriented in the same direction along the length of the corresponding strut section.

[0383] Example 98. A prosthetic valve as described in any example herein, particularly as described in Example 97, wherein the proximal end of the skirt is sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of whip stitches wrapped around each of the respective strut sections and a junction locking knot around the junction positioned therebetween, and the plurality of whip stitches around one of the strut sections are angled in an opposite direction to the plurality of whip stitches wrapped around the other strut section.

[0384] Example 99. A prosthetic valve as described in any example herein, particularly any one of Examples 91 to 98, wherein the skirt distal end is connected to at least one strut section at the inflow end portion of the valve via at least one additional primary suture and an additional secondary suture, the at least one additional primary suture being passed in an in-and-out pattern through the inflow end portion at the piercing point, the additional secondary suture being passed through the primary suture and wrapped around the strut section at the inflow end portion in a series of whip stitches spaced apart from each other along the length of the strut section, and the skirt distal end is further connected to at least one joint at the end of the strut section at the inflow end portion via an additional joint locking knot.

[0385] Example 100. A prosthetic valve as described in any example herein, particularly as described in Example 99, wherein the additional primary suture follows the shape of the strut section disposed around the inflow end portion.

[0386] Example 101 The prosthetic valve described in any example herein, particularly any one of Examples 91 to 100, wherein the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0387] Example 102 The prosthetic valve described in any example herein, particularly example 101, wherein the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0388] Example 103 The prosthetic valve described in any example herein, especially example 101, wherein the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

[0389] Example 104 The prosthetic valve described in any example herein, especially example 101, wherein the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.3.

[0390] Example 105. The prosthetic valve described in any example herein, particularly any one of Examples 91 to 104, wherein the proximal end of the skirt includes a series of pre-formed apertures.

[0391] Example 106. A prosthetic valve as described in any example herein, particularly as described in Example 105, wherein the aperture is dimensioned to receive at least one primary suture, thereby serving as a penetration point.

[0392] Example 107 The prosthetic valve of any example herein, particularly example 105 or 106, wherein the apertures are evenly spaced from one another.

[0393] Example 108. The prosthetic valve described in any example herein, particularly any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or smaller than the diameter of the primary suture.

[0394] Example 109. A prosthetic valve as described in any example herein, particularly any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or smaller than the combined diameter of the primary and secondary sutures.

[0395] Example 110. The prosthetic valve described in any example herein, particularly any one of Examples 91 to 109, wherein the at least one primary suture comprises two primary sutures, the two primary sutures being threaded in reverse in an in-and-out pattern through the same penetration point.

[0396] Example 111. A prosthetic valve as described in any example herein, particularly any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or smaller than the diameter of the two primary sutures.

[0397] Example 112. A prosthetic valve as described in any example herein, particularly as described in Example 111, wherein the diameter of the aperture is equal to or smaller than the combined diameter of the two primary and secondary sutures.

[0398] Example 113 The prosthetic valve of any example herein, particularly any one of Examples 91 to 112, wherein the primary suture comprises a multifilament suture.

[0399] Example 114 The prosthetic valve described in any example herein, particularly any one of Examples 91 to 113, wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0400] Example 115. A prosthetic valve as described in any example herein, particularly any one of Examples 91 to 114, wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0401] Example 116. A method for assembling a prosthetic valve, comprising: passing a primary suture in an in-and-out pattern through the skirt proximal end of the skirt; approximating the proximal end of the skirt with the primary suture threaded therethrough to at least one strut section of a frame of the prosthetic valve; sewing a secondary suture through the primary suture and around at least one strut section in a manner to form a plurality of whip stitches wrapped around the strut section up to a final whip stitch; forming a joint locking knot extending from the final whip stitch around a joint at each end of a corresponding strut section, the joint locking knot configured to maintain tension on the plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint; A method comprising:

[0402] Example 117. The method described in any example herein, particularly Example 116, wherein the step of forming the joint locking knot includes extending a secondary suture from a final whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0403] Example 118. The method described in any example herein, particularly example 117, wherein the step of forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0404] Example 119. The method described in any example herein, particularly Example 118, wherein the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself, and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0405] Example 120. The method described in any example herein, particularly Example 119, wherein the step of forming a joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0406] Example 121. The method described in any example herein, particularly any one of Examples 117 to 120, wherein the step of forming the transition section includes extending the secondary suture in an oblique direction from one radial side of the joint toward an opposite radial side of the joint, and from one lateral side of the joint to an opposite lateral side of the joint.

[0407] Example 122. The method of any example herein, particularly any one of Examples 116 to 121, wherein forming multiple whip stitches around any single strut section includes forming multiple angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0408] Example 123. The method described in any example herein, particularly example 122, wherein the step of sewing a secondary suture around at least one strut section includes sewing around at least two strut sections separated from one another by a reciprocal joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0409] Example 124. The method described in any example herein, particularly any one of Examples 116 to 123, wherein the proximal end of the skirt includes a series of preformed apertures, and the step of threading the primary suture includes threading the primary suture in an in-and-out pattern through the series of preformed apertures.

[0410] Example 125 The method of any example herein, particularly any one of Examples 116 to 124, wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0411] Example 126. An artificial valve, a frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of strut sections intersecting at joints; a valve leaflet assembly including a plurality of leaflets mounted within a frame and configured to regulate flow through the prosthetic valve; a skirt disposed about the frame, the skirt including a skirt proximal end and a skirt distal end; Including, The skirt proximal end is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the skirt proximal end, the secondary suture forming a series of blind-through whip stitches spaced from one another along the length of the strut section, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, the primary suture wrap section extending from the strut wrap section and looped around the primary suture, skirt An artificial valve passes between the

[0412] Example 127. The prosthetic valve described in any example herein, particularly example 126, wherein the proximal end of the skirt follows a zigzag pattern.

[0413] Example 128. The prosthetic valve described in any example herein, particularly example 127, wherein at least one primary suture tracks a zigzag pattern in the proximal end of the skirt.

[0414] Example 129. A prosthetic valve as described in any example herein, particularly any one of Examples 126 to 128, wherein the primary suture defines a series of running stitch portions, each primary suture wrapped section being looped around a corresponding running stitch portion and extending between the running stitch portion and the proximal end of the skirt.

[0415] Example 130 The prosthetic valve described in any example herein, particularly any one of Examples 126 to 129, wherein the secondary suture does not pass through the skirt.

[0416] Example 131 The prosthetic valve described in any example herein, particularly any one of Examples 126 to 130, wherein the secondary suture does not pass through the primary suture.

[0417] Example 132. A prosthetic valve as described in any example herein, in particular any one of Examples 126 to 131, wherein each junction is defined between two opposite axial sides including a proximal junction side and a distal junction side; between two opposite radial sides including a medial junction side and a lateral junction side; and between two opposite lateral sides including a first lateral junction side and a second lateral junction side, and the proximal end of the skirt is further connected to at least one junction at the end of the strut section via a junction locking knot formed by a second suture, and the junction locking knot is configured to maintain tension on a plurality of non-penetrating whip stitches wrapped around the corresponding strut section leading to the first lateral junction side.

[0418] Example 133. Each joint lock knot is a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from the second junction lateral side; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 132。 The prosthetic valve of any embodiment herein, in particular embodiment 132.

[0419] Example 134. An artificial valve as described in any example herein, particularly as described in Example 133, wherein the transition section extends in an oblique direction from one radial side of the joint to the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0420] Example 135 The prosthetic valve described in any example herein, particularly example 133 or 134, wherein both the first loop and the second loop are tightly tensioned around the coaptation.

[0421] Example 136. A prosthetic valve as described in any example herein, particularly any one of Examples 132 to 135, wherein each of the plurality of non-penetrating whip stitches wrapped around a single strut section is an angled non-penetrating whip stitch oriented in the same direction along the length of the corresponding strut section.

[0422] Example 137. A prosthetic valve as described in any example herein, particularly as described in Example 136, wherein the proximal end of the skirt is sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a junction locking knot around the junction positioned therebetween, and wherein the plurality of non-penetrating whip stitches around one of the strut sections are angled in an opposite direction to the plurality of non-penetrating whip stitches wrapped around the other strut section.

[0423] Example 138. A prosthetic valve as described in any example herein, in particular any one of Examples 126 to 137, wherein the skirt distal end is connected to at least one strut section at the inflow end portion of the valve via at least one additional primary suture and an additional secondary suture, the at least one additional primary suture being passed in an in-and-out pattern through the inflow end portion at the piercing point, the additional secondary suture being passed through the primary suture and wrapped around the strut section at the inflow end portion in a series of whip stitches spaced apart from each other along the length of the strut section, and the skirt distal end is further connected to at least one joint at the end of the strut section at the inflow end portion via an additional joint locking knot.

[0424] Example 139. A prosthetic valve as described in any example herein, particularly as described in Example 138, wherein the additional primary suture follows the shape of the strut section disposed around the inflow end portion.

[0425] Example 140 The prosthetic valve described in any example herein, particularly any one of Examples 126 to 139, wherein the primary suture comprises a multifilament suture.

[0426] Example 141 The prosthetic valve described in any example herein, particularly any one of Examples 126 to 140, wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0427] Example 142. A prosthetic valve as described in any example herein, particularly any one of Examples 126 to 141, wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0428] Example 143. A method of assembling a prosthetic valve, the method comprising: passing a primary suture in an in-and-out pattern through the skirt proximal end of the skirt; approximating the proximal end of the skirt with the primary suture threaded therethrough to at least one strut section of a frame of the prosthetic valve; looping a secondary suture around at least one strut section and around the primary suture in a manner to form a plurality of blind-through whip stitches wrapped around the strut section up to a final blind-through whip stitch, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section and passing between the primary suture and a proximal end of the skirt around the primary suture; A method comprising:

[0429] Example 144. A method as described in any example herein, particularly example 143, wherein the step of forming each blind whip stitch includes the step of extending a secondary suture across one radial side of the strut section, folding it back over the axial side of the strut section, and extending it back across the opposite radial side of the strut section, thereby forming a strut wrap section.

[0430] Example 145. The method described in any example herein, particularly example 144, wherein the step of forming each blind whip stitch further includes the step of passing a secondary suture between the running stitch portion of the primary suture and the proximal end of the skirt and folding it back over the running stitch portion to form a primary suture wrapped section.

[0431] Example 146. The method described in any example herein, particularly example 144, wherein the step of forming each blind whip stitch further includes the step of passing a secondary suture over the running stitch portion of the primary suture and looping it back over the running stitch portion and between the running stitch portion and the proximal end of the skirt, thereby forming a primary suture wrapped section.

[0432] Example 147. The method of any example herein, especially example 145 or 146, wherein the skirt is an outer skirt and the running stitch portion is an inner stitch portion of the primary suture.

[0433] Example 148. The method of any example herein, particularly any one of Examples 143 to 147, further comprising forming a joint locking knot extending from the final non-penetrating whip stitch around the joint at each end of the corresponding strut section, the joint locking knot configured to maintain tension on the plurality of non-penetrating whip stitches wrapped around the strut section leading to the lateral side of the first joint.

[0434] Example 149. The method described in any example herein, particularly example 148, wherein the step of forming the joint locking knot includes extending a secondary suture from a final blind-through whip stitch disposed on a first lateral side of the joint, over one axial side of the joint, in a direction toward a second lateral side of the joint, thereby forming a transition section of the joint locking knot.

[0435] Example 150. The method described in any example herein, particularly example 149, wherein the step of forming the joint locking knot further includes extending a secondary suture from the transition section around a strut section extending from a second lateral side of the joint, thereby forming a first loop of the joint locking knot.

[0436] Example 151. The method described in any example herein, particularly example 150, wherein the step of forming the joint locking knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back onto itself, and passing it through the first loop, thereby forming a second loop of the joint locking knot.

[0437] Example 152. The method described in any example herein, particularly example 151, wherein the step of forming a joint locking knot further includes the step of forcibly pulling the tail of the second loop to tighten both the first loop and the second loop around the joint.

[0438] Example 153. The method described in any example herein, particularly any one of Examples 149 to 152, wherein the step of forming the transition section includes extending the secondary suture in an oblique direction from one radial side of the joint toward an opposite radial side of the joint, and from one lateral side of the joint to an opposite lateral side of the joint.

[0439] Example 154. The method of any example herein, particularly any one of Examples 148 to 153, wherein forming a plurality of whip stitches around any single strut section includes forming a plurality of angled whip stitches that are oriented in the same direction around the length of the corresponding strut section.

[0440] Example 155. The method described in any example herein, particularly example 154, wherein the step of forming a plurality of whip stitches around at least one strut section includes forming a plurality of whip stitches around at least two strut sections separated from one another by a mutual joint such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, while all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite the first direction.

[0441] It is also understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for clarity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate in any other described embodiment of the invention. A feature described in the context of an embodiment should not be considered an essential feature of that embodiment, unless expressly specified otherwise.

[0442] In view of the many possible embodiments to which the principles of this disclosure may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be viewed as limiting in scope. Rather, that scope is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of those claims. [Explanation of symbols]

[0443] 10 Valve longitudinal axis 100 Artificial Valves 100´ Mechanically Expandable Valve 100´´ Balloon Expandable Valve 102 Outflow end part 103 Outflow end 103´´ Outflow end 104 Inflow end section 105 Inflow end 105´´ Inflow end 106 frames 106´ frame 106´´ Frame 108 cells 110 Strut 110´ strut 110´´ angled struts 111 Strut section 111´´a strut section 111´´b strut section 111a Strut Section 111b Strut Section 111c strut section 111d strut section 111e strut section 111f strut section 111m strut section 111n strut section 111o strut section 111p Strut section 111r strut section 111s strut section 111t strut section 111u Strut Section 111v Strut Section 111w strut section 112 Commissure window frame 114 Strut 116 Non-vertex Junction 116´ Non-vertex joint 116´´ Non-vertex joint 116´´a Non-vertex joint 116´´b Non-vertex joint 116´´c Non-vertex joint 116b Joint 116f joint 116m joint 116n joint 116o joint 116p joint 116q joint 116r joint 116s joint 116t joint 118 Inflow Vertex 118´ Inflow apex 118´´ Inflow apex 120 Outflow Apex 120´ Outflow apex 120´´ Outflow apex 122 Actuator Assembly 123 Skirt 124 outer skirt 126 Skirt outer surface 125 Inner surface of skirt 128 Distal end of skirt 129 Skirt proximal end 130 Leaflet Assembly 132 Valve Leaflet 132a Leaflet 132b Leaflet 134 Cusp end part 135 Cusp Edge 136 Free edge 138 tabs 140 Commissure 142 aperture 144 Primary Suture 144a Primary suture 144b Primary suture 146 Inner stitching 148 outer stitching 148a Outer stitching 148b Outer stitching 148c outer stitching 150 penetration points 150a penetration point 150b piercing point 150n final penetration point 152 Inner surface of valve leaflet 154 Leaflet outer surface 156 Secondary suture 158 Self-Tightening Construct 160 Loops 160a Loop 160b Loop 162 Generally horseshoe-shaped (or U-shaped) section 164 Suture tensioning part 166r knot 166s knot 166t knot 170 Secondary Suture 172 whip stitch 172a whip stitch 172b whip stitch 172c whip stitch 172n Final whip stitch 174 Joint Lock Knot 174m Joint Lock Knot 174n Joint Lock Knot 174o Joint Lock Knot 174p Joint Lock Knot 174q Joint Lock Knot 174r Joint Lock Knot 174s Joint Lock Knot 174t Joint Lock Knot 176 Transition Section 178 First Loop 180 Second Loop 182 Non-penetrating whip stitch 182a Non-penetrating whip stitch 182a´ Non-penetrating whipstitch 182a´´ Non-penetrating whipstitch 182b Non-penetrating whip stitch 182b´ Non-penetrating whip stitch 182b´´ Non-penetrating whip stitch 182c Non-penetrating whip stitch 182d non-penetrating whip stitch 182n Final non-penetrating whip stitch 184 Strut Wrap Section 184a Strut Wrap Section 184a´ Strut wrap section 184a´´ Strut wrap section 184b Strut wrap section 184c strut wrap section 185 Strut Loop Section 185a Strut Loop Section 185b Strut Loop Section 186 Primary Suture Wrap Section 186a Primary suture wrapping section 186a´ Primary suture wrapping section 186a´´ Primary suture wrapping section 186b Primary suture wrapping section 186b´ Primary suture wrapping section 186b´´ Primary suture wrapping section 186c Primary suture wrapping section 186n Final primary suture wrapping section 190 Strut proximal lateral part 191 Strut distal lateral part 192 Strut inner side 193 Strut outer side 194 Proximal lateral part of junction 195 Distal lateral part of junction 196 Inner side of joint 197 Outer side of joint 198 First joint lateral side 199 Second joint lateral side

Claims

1. An artificial valve, a frame movable between a radially compressed configuration and a radially expanded configuration, said frame including a plurality of strut sections intersecting at joints; a leaflet assembly including a plurality of leaflets mounted within the frame and configured to regulate flow through the prosthetic valve, each leaflet including a rounded cusp end portion defining a cusp edge, a free edge opposite the cusp edge, and a pair of oppositely directed tabs separating the cusp edge and the free edge; Including, each cusp end portion is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the cusp end portions, the secondary sutures forming a series of blind-through whip stitches spaced from one another along the length of the strut section, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section, looped around the primary suture, and passing between the primary suture and the valve leaflet.

2. 2. The prosthetic valve of claim 1, wherein the primary suture defines a series of running stitch portions, each primary suture wrap section being looped around a corresponding running stitch portion and extending between the running stitch portion and the rounded cusp end portion.

3. The prosthetic valve of claim 1 or 2, wherein the secondary sutures do not pass through the valve leaflets.

4. The prosthetic valve of claim 1 , wherein the secondary sutures do not pass through the primary sutures.

5. 5. The prosthetic valve of claim 1, wherein each junction is defined between two opposing axial sides, including a proximal junction side and a distal junction side; between two opposing radial sides, including a medial junction side and a lateral junction side; and between two opposing lateral sides, including a first lateral junction side and a second lateral junction side, and wherein the cusp end portion is further connected to at least one junction at an end of the strut section via a junction locking knot formed by a second suture, the junction locking knot being configured to maintain tension on a plurality of the blind-through whip stitches wrapped around the corresponding strut section leading to the first lateral junction side.

6. Each joint locks the knot a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from a lateral side of the second joint; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 6. The prosthetic valve of claim 5, comprising:

7. 7. The prosthetic valve of claim 6, wherein the transition section extends in an oblique direction from one radial side of the commissure to the opposite radial side of the commissure and from one lateral side of the commissure to the opposite lateral side of the commissure.

8. 8. The prosthetic valve of claim 6 or 7, wherein both the first loop and the second loop are tensioned around the coaptation.

9. 9. The prosthetic valve of claim 5, wherein each of a plurality of blind whip stitches wrapped around a single strut section is an angled blind whip stitch oriented in the same direction along the length of the corresponding strut section.

10. 10. The prosthetic valve of claim 9, wherein the cusp end portions are sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of blind-through whip stitches wrapped around each of the respective strut sections and a joint-locking knot around the junction positioned therebetween, the plurality of blind-through whip stitches around one of the strut sections being angled in an opposite direction to the plurality of blind-through whip stitches wrapped around the other strut section.

11. 11. The prosthetic valve of claim 1, wherein the prosthetic valve lacks fabric strips and / or cloth between the cusp end portions of the leaflets and the strut sections to which they are attached.

12. An artificial valve, a frame movable between a radially compressed configuration and a radially expanded configuration, said frame including a plurality of strut sections intersecting at joints; a valve leaflet assembly mounted within the frame and including a plurality of leaflets configured to regulate flow through the prosthetic valve; and a skirt disposed about the frame, the skirt including a skirt proximal end and a skirt distal end; Including, the proximal skirt end is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture being threaded in an in-and-out pattern through the proximal skirt end, the secondary suture forming a series of blind-through whip stitches spaced from one another along the length of the strut section, each blind-through whip stitch including a strut wrap section and a primary suture wrap section, the strut wrap section looped around the strut section, and the primary suture wrap section extending from the strut wrap section, looped around the primary suture, and passing between the primary suture and the skirt.

13. 13. The prosthetic valve of claim 12, wherein the primary suture defines a series of running stitch portions, each primary suture wrap section being looped around a corresponding running stitch portion and extending between the running stitch portion and the skirt proximal end.

14. 14. The prosthetic valve of claim 12 or 13, wherein the secondary sutures do not pass through the skirt.

15. 15. The prosthetic valve of claim 12, wherein the secondary sutures do not pass through the primary sutures.

16. 16. The prosthetic valve of claim 12, wherein each joint is defined between two opposing axial sides, including a proximal joint side and a distal joint side; between two opposing radial sides, including a medial joint side and a lateral joint side; and between two opposing lateral sides, including a first lateral joint side and a second lateral joint side, and wherein the proximal skirt end is further connected to at least one joint at an end of the strut section via a joint locking knot formed by a second suture, the joint locking knot being configured to maintain tension on a plurality of the blind-through whip stitches wrapped around the corresponding strut section leading to the first lateral joint side.

17. Each joint locks the knot a transition section extending on one axial side of the joint in a direction from the first joint lateral side to the second joint lateral side; a first loop extending from the transition section and extending around a strut section extending from a lateral side of the second joint; a second loop extending from the first loop between the transition section and the junction and folded back on itself to extend through the first loop; and 17. The prosthetic valve of claim 16, comprising:

18. 18. The prosthetic valve of claim 17, wherein the transition section extends in an oblique direction from one radial side of the commissure to the opposite radial side of the commissure and from one lateral side of the commissure to the opposite lateral side of the commissure.

19. 19. The prosthetic valve of claim 17 or 18, wherein both the first loop and the second loop are tensioned around the coaptation.

20. 20. The prosthetic valve of claim 16, wherein each of a plurality of blind whip stitches wrapped around a single strut section is an angled blind whip stitch oriented in the same direction along the length of the corresponding strut section.

21. 21. The prosthetic valve of claim 20, wherein the skirt proximal end is sewn to at least two strut sections extending from both lateral sides of a selected junction via a plurality of blind-through whip stitches wrapped around each of the respective strut sections and a joint locking knot around the junction positioned therebetween, the plurality of blind-through whip stitches around one of the strut sections being angled in an opposite direction to the plurality of blind-through whip stitches wrapped around the other strut section.

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