Artificial valve leaflet and skirt attachment configuration to the frame

Abstract

The present invention relates to an implantable artificial device, such as an artificial heart valve, and to a mounting configuration and method for attaching a soft component, such as a valve leaflet or skirt, to the frame of such an artificial valve. [Solution] The valve leaflets are connected to the struts of the frame via primary sutures, which are passed in an in-and-out pattern along the cusp end portion of the valve leaflets, and the secondary sutures are passed around the struts through the primary sutures and have a plurality of self-tightening structures configured to contract on the struts under tension.

Description

Technical Field

[0001] The present invention relates to implantable artificial devices (such as artificial heart valves, etc.), and relates to an attachment configuration and method for attaching a soft component (such as a valve tip or skirt, etc.) to the frame of such an artificial valve.

Background Art

[0002] Natural heart valves (such as aortic valves, pulmonary valves, and mitral valves, etc.) function to ensure proper directional flow from (and to) the heart and between the chambers of the heart, and supply blood to the entire cardiovascular system. Various valvular diseases can invalidate the valve and may require replacement with an artificial valve. Surgical procedures can be performed to repair or replace the heart valve. Since surgery is prone to a number of clinical complications, less invasive alternative techniques have been developed over the years to deliver an artificial heart valve on a catheter and implant it over the naturally dysfunctional valve.

[0003] Different types of artificial heart valves are known to date, including balloon-expandable valves, self-expandable valves, and mechanically expandable valves. Also, different methods of delivery and implantation are known, which can vary according to the site of implantation and the type of artificial valve. One exemplary technique involves the use of a delivery assembly to deliver an artificial valve in a crimped configuration from an incision that can be positioned in the patient's femoral artery or iliac artery towards the naturally dysfunctional valve. Once the artificial valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomical structure (such as the valve annulus of the natural valve, etc.), and the delivery assembly can then be retrieved.

[0004] One of the complications that can be associated with implanted artificial heart valves is thrombus formation on the prosthetic structure, which can result in reduced leaflet mobility or impaired jointing, reduced effective area of ​​the valve orifice, increased transvalvular pressure gradient, or transvalvular regurgitation. Thrombi can form due to tissue inward growth in the fabric components of the prosthetic valve (e.g., fabric used as an intermediate to connect the prosthetic valve leaflets to its frame). Therefore, there is a need for methods and configurations of connecting the leaflets to the frame that minimize or eliminate the need for incorporating fabric components, thereby reducing the risk of tissue inward growth 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] U.S. Patent Application Publication No. 2019 / 0060057 [Patent Document 9] U.S. Patent Application Publication No. 2018 / 0153689 [Patent Document 10] U.S. 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] U.S. Patent Application Publication No. 2018 / 0325665 [Patent Document 15] U.S. Patent Application Publication No. 2019 / 0105153 [Overview of the Initiative] [Means for solving the problem]

[0006] This disclosure relates to an artificial heart valve comprising an expandable frame and leaflet assembly, wherein the leaflets are connected to struts of the frame via primary sutures, the primary sutures are passed in an in-and-out pattern along the cusp end portion of the leaflets, and secondary sutures are passed around the struts through the primary sutures and have a plurality of self-tightening constructs configured to contract over the struts under tension.

[0007] According to one aspect of the present invention, an artificial valve is provided, the artificial valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration; and a leaflet assembly comprising a plurality of leaflets mounted within the frame and configured to regulate flow through the artificial valve. The frame comprises a plurality of intersecting struts. Each leaflet comprises a rounded cusp end portion, the 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 and secondary suture, the at least one primary suture passing through the cusp end portion in an in-and-out pattern at the penetration point, the secondary suture passing through the primary suture around at least one section of at least one strut, the secondary suture comprising a plurality of self-tightening constructs, each self-tightening construct comprising at least one loop configured to contract around the strut under tension.

[0009] According to some embodiments, the valve leaflet includes an inner surface and an outer surface, and the primary suture includes a plurality of inner stitch portions arranged along the inner surface of the valve leaflet and a plurality of outer stitch portions arranged along the outer surface of the valve leaflet, with each inner stitch portion and each outer stitch portion defined between their respective penetration points.

[0010] According to some embodiments, the self-tightening structure is defined between two through points that define at least one outer stitch portion between them.

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

[0012] According to some embodiments, each self-tightening structure further includes a U-shaped section that partially extends between at least one loop and a strut.

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

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

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

[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 valve tip includes a series of pre-formed apertures.

[0021] According to some embodiments, the apertures are sized to receive at least one primary suture, thereby serving as penetration points.

[0022] According to some embodiments, the apertures are evenly spaced from each other.

[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 smaller than the combined diameter of the primary and secondary sutures.

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

[0026] According to some embodiments, at least one primary suture comprises two primary sutures, which are passed in opposite directions in an in-and-out pattern through the same penetration point.

[0027] According to some embodiments, the diameter of the aperture is equal to or less 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, at least one primary suture tracks the curvature of at least one cusp margin.

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

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

[0032] According to some embodiments, the artificial valve lacks a fabric strip and / or cloth between the cusp end portions of the valve leaflets and the strut to which they are attached.

[0033] According to another aspect of the present invention, a method for assembling an artificial valve is provided, the method comprising the step of passing a primary suture through the cusp end portion of a valve leaflet in an in-and-out pattern. The method further comprises the step of approximating the cusp end portion through which the primary suture has passed to at least one strut of the frame of the artificial valve. The method further comprises the step of sewing a secondary suture through the primary suture and around at least one strut in a manner that forms a plurality of self-tightening constructs, each self-tightening construct being formed to include at least one loop configured to contract around a strut under tension.

[0034] According to some embodiments, the step of sewing in a secondary suture includes passing the secondary suture radially outward through the primary suture at the penetration point, thereby forming at least one loop around at least one strut.

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

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

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

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

[0039] According to another aspect of the present invention, an artificial valve is provided, comprising: a frame movable between a radially compressed configuration and a radially expanded configuration; and a leaflet assembly comprising a plurality of leaflets mounted within the frame and configured to regulate flow through the artificial valve. The frame comprises a plurality of strut sections intersecting at joints. Each joint is defined between two opposite axial sides including a proximal and distal joint; between two opposite radial sides including an inner and outer joint; and between two opposite lateral sides including a first lateral joint and a second lateral joint.

[0040] Each valve leaflet includes a rounded cusp end portion, which defines 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 and secondary suture, the at least one primary suture passing through the cusp end portion in an in-and-out pattern at the penetration point, and the secondary suture passing through the primary suture and wrapped around the strut section in a series of whip stitches spaced apart from each other 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 lock knot formed by a second suture, the joint lock knot being configured to maintain tension on a plurality of whip stitches wrapped around the corresponding strut section leading to the lateral side of the first joint.

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

[0043] According to some embodiments, the transition section extends obliquely 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.

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

[0045] According to some embodiments, each of the multiple whipstitches wrapped around a single strut section is an angled whipstitch oriented in the same direction along the length of the corresponding strut section.

[0046] According to some embodiments, the cusp end portion is sutured to at least two strut sections extending from both lateral sides of a selected joint via a plurality of whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of whip stitches around one of the strut sections are angled in the opposite direction to that of 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 valve 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 arranged at equal intervals from one another.

[0054] According to some embodiments, the diameter of the aperture is equal to or less 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, at least one primary suture comprises two primary sutures, which are passed in opposite directions in an in-and-out pattern through the same penetration point.

[0057] According to some embodiments, the diameter of the aperture is equal to or less 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, at least one primary suture tracks the curvature of at least one cusp margin.

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

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

[0062] According to some embodiments, the artificial valve lacks a fabric strip and / or cloth between the cusp end portions of the valve leaflets and the strut section and joint to which they are attached.

[0063] According to another aspect of the present invention, a method for assembling an artificial valve is provided, the method comprising the step of passing a primary suture through the cusp end portion of a valve leaflet in an in-and-out pattern. The method further comprises the step of approximating the cusp end portion through which the primary suture has passed to at least one strut section of the frame of the artificial valve. The method further comprises the step of sewing a secondary suture through the primary suture and around the at least one strut section in such a manner that it forms a plurality of whip stitches wrapped around the strut section up to a final whip stitch.

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

[0065] According to some embodiments, the step of forming a joint lock knot includes extending a secondary suture from a final whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0069] According to some embodiments, the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0070] According to some embodiments, the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

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

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

[0073] According to another aspect of the present invention, an artificial valve is provided, the artificial valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration; and a leaflet assembly comprising a plurality of leaflets mounted within the frame and configured to regulate flow through the artificial valve. The frame comprises a plurality of strut sections intersecting at the joint. Each leaflet comprises a rounded cusp end portion, the 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 passing through the cusp end portion in an in-and-out pattern, and the secondary sutures forming a series of non-penetrating whipstitches spaced apart from each other along the length of the strut section. Each non-penetrating whipstitch includes 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, being looped around the primary suture, and passing between the primary suture and the valve leaflet.

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

[0076] According to some embodiments, the secondary suture does not penetrate the valve leaflet.

[0077] According to some embodiments, the secondary suture does not penetrate the primary suture.

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

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

[0080] According to some embodiments, the transition section extends obliquely 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.

[0081] According to some embodiments, the transition section extends obliquely 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.

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

[0083] According to some embodiments, each of the multiple non-penetrating whipstitches wrapped around a single strut section is an angled non-penetrating whipstitch oriented in the same direction along the length of the corresponding strut section.

[0084] According to some embodiments, the cusp end portion is sutured to at least two strut sections extending from both lateral sides of a selected joint via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of non-penetrating whip stitches around one of the strut sections are angled in the opposite direction to that of the plurality of non-penetrating whip stitches wrapped around the other strut section.

[0085] According to some embodiments, at least one primary suture comprises two primary sutures, the two primary sutures being passed in reverse in an in-and-out pattern.

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

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

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

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

[0090] According to another aspect of the present invention, a method for assembling an artificial valve is provided, the method comprising the step of passing a primary suture through the cusp end portion of a valve leaflet in an in-and-out pattern. The method further comprises the step of approximating the cusp end portion through which the primary suture has passed to at least one strut section of the frame of the artificial valve. The method further comprises the step of looping a secondary suture around at least one strut section and around the primary suture in such a manner that it forms a plurality of non-penetrating whipstitches wrapped around the strut section up to a final non-penetrating whipstitch. Each non-penetrating whipstitch comprises a strut-wrapped section and a primary suture-wrapped section, the strut-wrapped section being looped around the strut section, and the primary suture-wrapped section extending from the strut-wrapped section, passing between the primary suture and the valve leaflet, and being looped around the primary suture.

[0091] According to some embodiments, the step of forming each non-penetrating whipstitch includes forming a strut wrap-around section by extending a secondary suture across one radial side of the strut section, folding it over the axial side of the strut, and extending it rearward across the opposite radial side of the strut.

[0092] According to some embodiments, the step of forming each non-penetrating whip stitch further includes the step of forming a primary suture wrap section by 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 over the running stitch portion.

[0093] According to some embodiments, the step of forming each non-penetrating whip stitch further includes the step of passing the 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 to form a primary suture wrap section.

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

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

[0096] According to some embodiments, the step of forming a joint lock knot includes extending a secondary suture from a final non-penetrating whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0100] According to some embodiments, the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0101] According to some embodiments, the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

[0102] According to some embodiments, 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 each other by a joint, such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

[0103] According to another aspect of the present invention, an artificial valve is provided, the artificial valve comprising a frame, a leaflet assembly mounted within the frame, and a skirt disposed around the frame. The frame is movable between a radially compressed configuration and a radially expanded configuration and includes a plurality of strut sections that intersect at the joint. The leaflet assembly includes a plurality of leaflets configured to regulate the flow through the artificial valve. The skirt includes a skirt proximal end and a skirt distal end.

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

[0105] The proximal end of the skirt is connected to at least one strut section via at least one primary and secondary suture, the at least one primary suture passing through the proximal end of the skirt in an in-and-out pattern at the penetration point, and the secondary suture passing through the primary suture and wrapped around the strut section in a series of whip stitches spaced apart 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 lock knot formed by a second suture, the joint lock knot being configured to maintain tension on a plurality of whip stitches wrapped around the 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, at least one primary suture tracks the zigzag pattern of the proximal end of the skirt.

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

[0110] According to some embodiments, the transition section extends obliquely 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.

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

[0112] According to some embodiments, each of the multiple whipstitches wrapped around a single strut section is an angled whipstitch oriented in the same direction along the length of the corresponding strut section.

[0113] According to some embodiments, the proximal end of the skirt is sutured to at least two strut sections extending from both lateral sides of a selected joint via a plurality of whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of whip stitches around one of the strut sections are angled in the opposite direction to that of the plurality of whip stitches wrapped around the other strut section.

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

[0115] According to some embodiments, an additional primary suture follows the shape of the strut section arranged around the inlet 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 arranged at equal intervals from one another.

[0123] According to some embodiments, the diameter of the aperture is equal to or less 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, at least one primary suture comprises two primary sutures, which are passed in opposite directions in an in-and-out pattern through the same penetration point.

[0126] According to some embodiments, the diameter of the aperture is equal to or less 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 includes 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 arranged around the outer surface of the frame.

[0131] According to another aspect of the present invention, a method for assembling an artificial valve is provided, the method comprising the step of passing a primary suture through the proximal end of the skirt in an in-and-out pattern. The method further comprises the step of approximating the proximal end of the skirt, through which the primary suture has passed, to at least one strut section of the frame of the artificial valve. The method further comprises the step of sewing a secondary suture through the primary suture and around at least one strut section in such a manner that it forms a plurality of whip stitches wrapped around the strut section up to a final whip stitch. The method further comprises the step of 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 knot being configured to maintain tension on the plurality of whip stitches wrapped around the strut section leading to a first joint lateral side.

[0132] According to some embodiments, the step of forming a joint lock knot includes extending a secondary suture from a final whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0136] According to some embodiments, the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0137] According to some embodiments, the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

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

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

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

[0141] According to another aspect of the present invention, an artificial valve is provided, the artificial valve comprising a frame, a leaflet assembly mounted within the frame, and a skirt disposed around the frame. The frame is transitionable between a radially compressed configuration and a radially expanded configuration and includes a plurality of strut sections that intersect at the joint. The leaflet assembly includes a plurality of leaflets configured to regulate the flow through the artificial valve. The skirt includes a skirt proximal end and a skirt distal end.

[0142] The proximal end of the skirt is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture passing through the proximal end of the skirt in an in-and-out pattern, and the secondary sutures forming a series of non-penetrating whipstitches spaced apart from each other along the length of the strut section, each non-penetrating whipstitch 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, being looped around the primary suture, and passing between the primary suture and the valve leaflet.

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

[0144] According to some embodiments, at least one primary suture tracks the zigzag pattern of 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 being looped around the 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 suture does not penetrate the skirt.

[0147] According to some embodiments, the secondary suture does not penetrate the primary suture.

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

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

[0150] According to some embodiments, the transition section extends obliquely 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.

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

[0152] According to some embodiments, each of the multiple whipstitches wrapped around a single strut section is an angled whipstitch oriented in the same direction along the length of the corresponding strut section.

[0153] According to some embodiments, the proximal end of the skirt is sutured to at least two strut sections extending from both lateral sides of a selected joint via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of non-penetrating whip stitches around one of the strut sections are angled in the opposite direction to that of the plurality of non-penetrating whip stitches wrapped around the other strut section.

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

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

[0156] According to some embodiments, the primary suture includes 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 arranged around the outer surface of the frame.

[0159] According to another aspect of the present invention, a method for assembling an artificial valve is provided, the method comprising the step of passing a primary suture through the proximal end of the skirt in an in-and-out pattern. The method further comprises the step of approximating the proximal end of the skirt, through which the primary suture has passed, to at least one strut section of the frame of the artificial valve. The method further comprises the step of looping a secondary suture around at least one strut section and around a primary suture in such a manner that a plurality of non-penetrating whipstitches are wrapped around the strut section up to a final non-penetrating whipstitch, wherein each non-penetrating whipstitch comprises a strut-wrapping section and a primary suture-wrapping section, the strut-wrapping section being looped around the strut section, and the primary suture-wrapping section extending from the strut-wrapping section and passing between the primary suture and the proximal end of the skirt around the primary suture.

[0160] According to some embodiments, the step of forming each non-penetrating whip stitch includes forming a strut wrap section by extending a secondary suture across one radial side of the strut section, folding it over the axial side of the strut section, and extending it rearward across the opposite radial side of the strut section.

[0161] According to some embodiments, the step of forming each non-penetrating 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 over the running stitch portion to form a primary suture wrap section.

[0162] According to some embodiments, the step of forming each non-penetrating whip stitch further includes the step of passing the 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 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 the step of forming a joint lock knot extending from a final non-penetrating whip stitch around a joint at each end of a corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of non-penetrating whip stitches wrapped around a strut section leading to a first lateral side of the joint.

[0165] According to some embodiments, the step of forming a joint lock knot includes extending a secondary suture from a final non-penetrating whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0169] According to some embodiments, the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0170] According to some embodiments, the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

[0171] According to some embodiments, 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 each other by a joint, such that all whip stitches around one of the strut sections are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

[0172] Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, specification, and claims contained herein. 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 those skilled in the art to which the present invention relates. In case of any conflict, the patent specification (including definitions) shall prevail. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context explicitly indicates otherwise.

[0174] The following embodiments and aspects are described and illustrated in relation to systems, tools, and methods, and are intended to be illustrative and illustrative purposes only, and not limiting the scope. In various embodiments, one or more of the problems described above are reduced or eliminated, while other embodiments relate to 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 it clear to those skilled in the art how some embodiments may be put into practice. The drawings are for illustrative purposes only and do not attempt to show structural details of the embodiments in more detail than necessary for a basic understanding of the present invention. For clarity, some of the objects shown in the drawings are not to the correct scale. [Brief explanation of the drawing]

[0176] [Figure 1A] This is a perspective view of several embodiments of a mechanically expandable artificial valve. [Figure 1B] This is a perspective view of a balloon-inflatable artificial valve according to several embodiments. [Figure 2] This figure shows a single valve leaflet according to several embodiments. [Figure 3] This figure shows a valve leaflet assembly defined by three valve leaflets, according to several embodiments, before assembly. [Figure 4] This is an enlarged cross-sectional view of the cusp end portion of the valve leaflet, showing the primary suture being passed through the cusp end portion of the valve leaflet in an in-and-out pattern, according to several embodiments. [Figure 5A] This figure shows various stages of exemplary techniques for connecting a valve leaflet to a strut of the frame along its cusp end portion, according to several embodiments. [Figure 5B] This figure shows various stages of exemplary techniques for connecting a valve leaflet to a strut of the frame along its cusp end portion, according to several embodiments. [Figure 5C] This figure shows various stages of exemplary techniques for connecting a valve leaflet to a strut of the frame along its cusp end portion, according to several embodiments. [Figure 5D] This figure shows various stages of exemplary techniques for connecting a valve leaflet to a strut of the frame along its cusp end portion, according to several embodiments. [Figure 5E] This figure shows various stages of exemplary techniques for connecting a valve leaflet to a strut of the frame along its cusp end portion, according to several embodiments. [Figure 6] This figure shows exemplary configurations of valve leaflets connected to struts via first and secondary sutures, according to several embodiments. [Figure 7] This is an enlarged cross-sectional view of the cusp end portion of the valve leaflet, showing two primary sutures passed through the cusp end portion in an in-and-out pattern, according to several embodiments. [Figure 8] This figure shows another exemplary configuration of a valve leaflet connected to a strut via first and secondary sutures, according to several embodiments. [Figure 9A] This figure shows various stages of exemplary techniques for connecting valve leaflets along their cusp end portions to strut sections and joints of a frame, according to several embodiments. [Figure 9B] This figure shows various stages of exemplary techniques for connecting valve leaflets along their cusp end portions to strut sections and joints of a frame, according to several embodiments. [Figure 9C] This figure shows various stages of exemplary techniques for connecting valve leaflets along their cusp end portions to strut sections and joints of a frame, according to several embodiments. [Figure 9D] This figure shows various stages of exemplary techniques for connecting valve leaflets along their cusp end portions to strut sections and joints of a frame, according to several embodiments. [Figure 10] This is a partial view of an artificial valve having multiple strut sections and valve leaflets connected to joints, according to several embodiments. [Figure 11A] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 11B] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 11C] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 11D] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 12A] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 12B] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 12C] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 12D] This figure shows various stages of another exemplary technique for connecting the valve leaflets along their cusp end portions to the strut sections and joints of the frame, according to several embodiments. [Figure 13] This figure shows another example of a stitching configuration. [Figure 14] This figure shows yet another example of a sewing configuration. [Figure 15] This is a perspective view of an artificial valve with an outer skirt, according to several embodiments. [Figure 16] Figure 15 is a partial view of an artificial valve, which, according to several embodiments, includes a skirt connected to multiple strut sections and joints. [Figure 17] This is a perspective view of another exemplary artificial valve with an outer skirt, according to several embodiments. [Figure 18] Figure 17 is a partial view of an artificial valve, which, according to several embodiments, includes a skirt connected to multiple strut sections and joints. [Modes for carrying out the invention]

[0177] The following description will explain various aspects of this disclosure. Certain configurations and details are described to provide a thorough understanding of the different aspects of this disclosure for explanatory purposes. However, it will also be apparent to those skilled in the art that this disclosure can be practiced without certain details being presented herein. Furthermore, well-known features may be omitted or simplified to avoid obscuring this disclosure. To avoid excessive confusion from having too many reference numerals and lead lines on a particular drawing, some components will be introduced through one or more drawings and will not be explicitly identified in all subsequent drawings containing that component.

[0178] Figures 1A and 1B show perspective views of two exemplary types of artificial valve 100 according to several embodiments. It will be noted that reference numbers accompanied by a prime mark (´) or a double prime mark (´´) are used throughout Figures 1A and 1B to indicate different embodiments of the same element. Embodiments of the disclosed devices and systems may include any combination of different embodiments of the same element. Specifically, any reference to an element without a single prime mark or a double prime mark may refer to any alternative embodiment of the same element indicated by a single prime mark or a double prime mark.

[0179] The artificial valve 100 is deliverable over a catheter (not shown) to a target site in a patient and is radially expandable and compressible between a radially compressed (or crimped) configuration and a radially expanded configuration (shown in Figures 1A and 1B). The expanded configuration may 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 may relate to any expansion diameter between the radially compressed or crimped configuration and the fully expanded configuration. The artificial valve 100 of this disclosure may include any artificial valve configured to be implanted in a natural aortic valve, a natural mitral valve, a natural pulmonary valve, and a natural tricuspid valve.

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

[0181] As described above, the artificial valve 100 can be implanted against a natural anatomical structure by being delivered to the implantation site toward the target site via a delivery assembly that carries the valve 100 in a radially compressed or crimped configuration, and by expanding the valve 100 via various expansion mechanisms. Figure 1A shows an exemplary mechanically expandable valve 100', and all reference numbers with prime marks (') shown in Figure 1A refer to similar elements contained within a mechanically expandable valve. A mechanically expandable valve is a category of artificial valves that rely on a mechanical operating mechanism for expansion. The mechanical operating mechanism typically comprises multiple actuator assemblies, which are releasably coupled to each operating arm assembly of the delivery device and controlled via handles of the delivery device to actuate the actuator assemblies to expand the artificial valve to a desired diameter.

[0182] Figure 1B shows an exemplary balloon-inflatable valve 100'', and all reference numbers with double prime marks ('') shown in Figure 1B refer to similar elements contained within a balloon-inflatable valve. A balloon-inflatable valve is generally involved in the procedure of inflating a balloon within the prosthetic valve, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is fully expanded, the balloon is deflated and retrieved with the delivery device. While mechanically expandable valves 100'' and balloon-inflatable valves 100'' are described and illustrated in relation to Figures 1A and 1B, it will be clear that the prosthetic valve 100 may also include other expansion mechanisms (e.g., a self-expanding valve). A self-expanding valve includes a frame, which is shaped to automatically expand as soon as an external retaining structure (e.g., a capsule or a portion of the shaft (not shown)) is withdrawn proximal to the prosthetic valve.

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

[0184] As used herein, the term “proximal” generally refers to the location, orientation, or part of any device or component of a device that is closer to the user and further away from the implantation site.

[0185] As used herein, the term “distal” generally refers to the location, orientation, or part of any device or component of a device that is further from the user and closer to the implantation site.

[0186] As used herein, the term “outflow” refers to the region of the prosthetic valve through which blood flows out of 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 artificial valve through which blood flows into 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 valve leaflet assembly 130 mounted within the frame 106. The frame 106 may be made from a variety of suitable materials, including, but not limited to, plastically deformable materials (such as stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys, e.g., MP35N alloy), polymers, or combinations thereof). When constructed from a plastically deformable material, the frame 106 (e.g., frame 106'' (and thus balloon-expandable valve 100'')) may be crimped into a radially compressed configuration on 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, nickel-titanium alloys (e.g., Nitinol)). When constructed from a shape memory material, the frame 106 (for example, frame 106' (and thus the mechanically expandable valve 100')) can be crimped into a radially compressed configuration and constrained in the compressed configuration by insertion into a shaft or equivalent mechanism of a delivery device (not shown).

[0189] In the example illustrated in Figures 1A and 1B, the frame 106 is an annular, stent-like structure including a plurality of intersecting struts 110. In this application, the term “strut” encompasses vertical struts, angled struts, mounting posts, intersecting windows, and any similar structures described in Patent Documents 1 and 2, which are incorporated herein by reference. The struts 110 can be any elongated members or portions 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 inlet end 105 to the outlet end 103 of the frame, as shown, or the frame can vary in diameter along the height of the frame, as disclosed in Patent Document 3, which is incorporated herein by reference.

[0190] The end portions of the strut 110 form a vertex 120 at the outflow end 103 and a vertex 118 at the inflow end 105. The strut 110 can intersect at an additional non-vertex joint 116 formed between the outflow vertex 120 and the inflow vertex 118. The non-vertex joint 116 can be spaced evenly or unevenly between the outflow end 103 and the inflow end 105, and / or from each other and / or from the vertices 120 and 118.

[0191] According to some embodiments, the struts 110 are arranged in a grid-type pattern. In the exemplary embodiment illustrated in Figure 1A, the struts 110' are positioned obliquely to the valve longitudinal axis 10, or offset at some angle, and also radially offset from the valve longitudinal axis 10 when the valve 100' is in an extended position. It will become clear that the struts 110' can be offset by angles other than those shown in Figure 1B (for example, 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' may include openings or apertures in the regions of the inlet apex 118', outlet apex 120', and non-apex joints 116' of the struts 110'. Each hinge may be included where the apertures of the struts 110' overlap each other, via fasteners (e.g., rivets or pins) extending through the aperture. The hinges may allow the struts 110' to pivot relative to each other when the frame 106' is radially expanded or compressed.

[0193] According to some embodiments, the strut 110 includes a plurality of angled struts and vertical struts. In an exemplary embodiment illustrated in Figure 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 their respective hinges, but are otherwise pivotable or bendable relative to one another, allowing for frame expansion or compression. For example, the frame 106'' may be formed from a single piece of material (e.g., a metal tube) through a variety of processes (e.g., laser cutting, electroforming, and / or physical vapor deposition, etc.) while retaining the ability to collapse / expand radially in the absence of hinges, etc.

[0194] The leaflet assembly 130 comprises a plurality of leaflets 132 (for example, three leaflets), which are at least partially positioned within the frame 106 and configured to regulate the flow of blood through the prosthetic valve 100 from the inlet end 105 to the outlet end 103. While three leaflets 132 arranged to collapse in a tricuspid configuration are shown in the exemplary embodiments illustrated in Figures 1A and 1B, it will be clear that the prosthetic valve 100 may contain any other number of leaflets 132. The leaflets 132 may be made from flexible materials (derived from biological materials (e.g., bovine pericardium, or pericardium from other sources)), biocompatible synthetic materials, or other suitable materials as known in the Art, as well as as described in, for example, Patent Documents 4, 5, and 6, which are incorporated herein by reference.

[0195] Figure 2 shows a single representative valve leaflet 132, and Figure 3 shows three separate valve leaflets prior to mounting to and to the frame 106 according to several embodiments, which collectively define the valve leaflet assembly 130. Each valve leaflet 132 has a rounded cusp end portion 134 defining a cusp edge 135 on the opposite side of the free edge portion 136, and a pair of generally oppositely oriented tabs 138 separating the cusp edge portion 135 and the free edge portion 136. The cusp edge portion 135 forms a single scallop. The valve leaflet 132 further includes an inner surface 152 and an outer surface 154, the inner surface 152 being defined as the surface facing the valve longitudinal axis 10, and the outer surface 154 being on the opposite side to face the frame 106.

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

[0197] The leaflets 132 define a non-planar joining plane (unannotated) when their free edges 136 join to seal the blood flow through the prosthetic valve 100. The leaflets 132 are fixed to each other at their tabs 138, making it possible to form a commissure 140 of the leaflet assembly 130, which may be fixed directly or indirectly to a structural element (e.g., a commissure post) connected to or embedded in the frame 106. When fixed 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, a mechanically expandable valve 100' includes a plurality of actuator assemblies 122, which are configured to facilitate the expansion of the valve 100' and, in some cases, to lock the valve in the expanded configuration to prevent unintentional recompression. Figure 1A illustrates three actuator assemblies 122, which are mounted on the inner surface of a frame 106' and arranged at equal intervals around the inner surface of the frame 106', but it should be clear that different numbers of actuator assemblies 122 may be available, that actuator assemblies 122 may be mounted on the frame 106' around its outer surface, and that the circumferential spacing between the actuator assemblies 122 may be uneven. In some cases, as further illustrated in Figure 1B, the actuator assembly 122 can also function as a commutator post, and the commutator 140 of the valve leaflet assembly 130 can be connected to the commutator post. Further details relating to the structure and operation of the mechanically expandable valve and its delivery system are described in Patent Documents 7, 8, 9, and 10, as well as in U.S. Patent Applications 62 / 870,372 and 62 / 776,348, all of which are incorporated herein by reference.

[0199] According to some embodiments (for example, the exemplary embodiment illustrated in Figure 1B), the upper row of cells includes a plurality of axially extending window frame portions 112 (which define the commutation window) and a plurality of axially extending struts 114. Each axial strut 114 and each window frame portion 112 extends from a joint 116'' defined by the convergence of the lower ends of two angled struts 110'' to another joint 116'' defined by the convergence of the upper ends of two angled struts 110''. Each commutation window frame portion 112 is fitted with each commutation portion 140 of the valve leaflet structure 130.

[0200] An additional frame configuration may include a commissure post attached to the frame, which is configured to receive a commissure 140, either extending through a window portion defined therein or supporting the attachment of the commissure therein in various other ways. Alternatively, some of the cells 108 may be configured to receive a commissure 140 attached thereto. For example, the cells 108 in the top row may be configured to receive a tab 138 of the valve leaflet 132. Further details relating to the artificial valve (including the configuration in which the commissure may be attached to their frame) are described in Patent Documents 4, 11, 12, 1, 13, and 2; Patent Documents 14, 15, U.S. Patent Application No. 62 / 869,948, and U.S. Patent Application No. 62 / 813,643; and PCT Application No. PCT / US2019 / 61392, all of which are incorporated herein by reference. Any of the techniques and mechanisms disclosed in prior art may be used to connect the cross section 140 to the frame 106 (directly or indirectly).

[0201] According to some embodiments, the artificial valve 100 may further include a skirt 123 (for example, an outer skirt 124 fitted on the outer surface of the frame 106 (for example, shown in Figures 15 and 17)) which is configured to function as a sealing member held between the frame 106 and the surrounding tissue of the natural valve annulus (to which the artificial valve 100 is fitted), thereby reducing the risk of paravalvular leakage through the artificial 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, a primary suture 144 is passed through the cusp end portion 134 in an in-and-out pattern (also known in the art as a running stitch pattern). Figure 3 shows a primary suture 144 being sewn along the cusp end portion 134 of the valve leaflet 132. Figure 4 shows an enlarged cross-sectional view through the cusp end portion 134 and the primary suture 144 passing through it. As shown, the running stitch extends along the cusp end portion 134 in an in-and-out pattern through the penetration points 150, thereby defining a plurality of running stitch portions, including a plurality of internal stitch portions 146 arranged along the internal surface 152 of the valve leaflet and a plurality of external stitch portions 148 arranged along the external surface 154 of the valve leaflet, with each internal stitch portion 146 and each external stitch portion 148 defined between a set of continuous penetration points 150. Optionally, but preferably in some embodiments, the primary suture 144 follows the curvature of the cusp edge 135, meaning that the primary suture 144 runs along the cusp edge 135 or is generally parallel to the cusp edge 135.

[0203] Referring particularly to Figures 5A to 5E, exemplary techniques for connecting the valve leaflet 132 along its cusp end portion 134 to at least one section of at least one strut 110 of the frame 106 will be discussed here in accordance with this teaching. As shown in Figure 5A, the cusp end portion 134 (through which a primary suture is passed in an in-and-out pattern) approximates the strut 110, and the cusp end portion 134 is preferably positioned radially inward on the inside of the strut 110 (optionally in contact with the inside of the strut 110). According to some embodiments, a secondary suture 156 is sewn around at least one section of at least one strut 110 through a primary suture 144, and the secondary suture 156 includes 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] Although strut 110 is shown to have a rectangular cross-section in Figures 5A to 5E, this is merely for illustrative purposes, and it is clear that the cross-section of strut 110 can have a rounded shape, a circular shape, a polygonal shape, an irregular shape, or a shape that changes along the length of the strut. Furthermore, the cross-section of the strut can remain the same shape, but its size can change along the length of the strut.

[0205] The self-tightening structure 158 is formed by passing a secondary suture 156 radially outward through a primary suture 144 at a penetration point 150a, and by forming at least one loop 160 (e.g., loop 160a shown in Figure 5B) around the strut. According to some embodiments, the self-tightening structure 158 includes two or more loops 160 around the strut 110. For example, the secondary suture can be looped again, as shown in Figure 5C, to form a second loop 160b around the strut 110. Although two loops 160a and 160b are described and illustrated in relation to Figures 5A to 5E, it will be clear that the self-tightening structure 158 can include any other number of loops in alternative modifications.

[0206] As shown in Figure 5D, the secondary suture 156 is then passed under at least one loop 160 (for example, between both loops 160a, 160b and the strut 110), forming a generally horseshoe-shaped (or U-shaped) section 162, which is then passed through the primary suture 144 radially inward at the penetration point 150b. Thus, the resulting self-tightening structure 158 is defined between two penetration points 150 that define at least one outer stitched portion 148 between them.

[0207] The "radially inward" direction is directed 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 tension portions 164, which extend over the inner surface 152 of the valve leaflet and may be defined between a continuous self-tightening structure 158. As shown in Figure 5E, the suture tension portions 164 of the secondary suture 156 are defined by extending the secondary suture 156 over the inner surface 152 of the valve leaflet (for example, parallel to at least one inner stitch portion 146), and then by passing the secondary suture 156 again through the primary suture 144 in a radially outward direction at a continuous penetration point 150c (at which another self-tightening structure 158 may be formed in a similar manner). Figure 5E shows a section of a stitch pattern including three exemplary self-tightening structures 158.

[0209] The self-tightening construct 158 ​​is configured to tighten its grip on the valve leaflet 132 as its cusp end portion 134 is pulled radially inward. During cardiac diastole, the valve leaflet 132 collapses radially inward, effectively closing the prosthetic valve. This collapse exerts a radially inward-oriented tensile force at the cusp end portion 134, which in turn pulls the suture tension portion 164 radially inward. The suture tension portion 164 (displaced on the inner surface 152 of the valve leaflet) pulls the tails on both sides of each self-tightening construct 158 ​​along it, causing at least one loop 160 to contract around the strut 110. This contraction reduces the diameter of at least one loop 160, thus forming a mechanical interface between the outer surface of the strut 110 and the inner surface of at least one loop 160. This contraction results in static friction between the internal and external surfaces in 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 loop 160 is configured to be reduced in diameter when tension is applied to both ends of the self-tightening construct 158, which increases the grip of the secondary suture 156 around the strut 110, thereby preventing the valve leaflet 132 from sliding over the strut 110 along the resulting scallop line.

[0210] Advantageously, the primary suture 144 is threaded in an in-and-out pattern through the cusp end portion 134, allowing the primary suture 144 to act as a pledge or cushion between the secondary suture 156 and the valve leaflet 132. For example, the suture tension portion 164 (displaced on the inner surface 152 of the valve leaflet) can be pressed against the inner stitch portion 146 of the primary suture 144 during repeated diastolic and systolic cycles, so as to act as a pledge or cushion and prevent direct wear that might otherwise be applied to the valve leaflet 132.

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

[0212] Preferably, the diameter of the secondary suture 156 is sufficiently smaller than the diameter of the primary suture 144 so that passing the secondary suture 156 through the primary suture 144 does not break 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 diameter ratio of the secondary suture to the primary suture. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.8. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.5. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.3.

[0213] In prior art artificial valve devices, the inner skirt is attached to the inner surface of the frame to form a more suitable attachment surface for the valve leaflets. In contrast, the attachment configuration currently disclosed does not require the use of an intermediate fabric strip. This is because the primary suture 144 acts as a support structure, and the valve leaflets 132 can be attached to the frame 106 through the support structure via a secondary suture 156 that passes through the primary suture 144. A fabric strip along the inner surface of the frame 106 poses a risk of promoting tissue endografting and proliferation after implantation. Therefore, the absence of such a fabric or cloth component along the inside of the frame significantly reduces such a risk, thereby improving the long-term durability and functionality of the valve.

[0214] According to a preferred embodiment of the present invention, the attachment of the valve leaflets to the frame of the artificial valve along the scalloped edges of the leaflets lacks an intermediate fabric strip and / or cloth in between. Although tissue inward growth may still occur along the suture material (e.g., primary suture 144), the overall surface area of ​​the suture is significantly smaller than that of a conventionally used fabric strip, for example, which acts as an inner skirt component.

[0215] As shown, the attachment of the valve leaflet 132 to the strut 110 of the frame 106 is achieved via a secondary suture 156, which passes through the primary suture 144 instead of directly through the valve leaflet material. Thus, the primary suture 144 acts as a reinforcing member that resists the tearing of the suture along the cusp end portion 134, thereby reducing stress concentration on the valve leaflet 132 near the scallop line. Advantageously, in the region of valve leaflet attachment to the frame, the force applied to the valve leaflet 132 during the transition between the open and closed or joined states is distributed along the length of the primary suture 144. In such a manner, the primary suture 144 acts as a force distribution element that enhances the durability of the valve leaflet 132 over time, because the force is distributed over the primary suture 144 in a substantially equal manner along its length.

[0216] Returning to and further referring to Figure 2, the valve leaflet 132 may, in some embodiments, be provided with a series of pre-formed apertures 142 along its cusp end portion 134, which are configured to receive a primary suture 144 and define a penetration point 150, which can extend in an in-and-out pattern through the penetration point 150. In such embodiments, the apertures 142 can serve as the penetration point 150. In some embodiments, the apertures 142 may be spaced evenly apart from one another.

[0217] The secondary suture 156 passes through the primary suture 144 at the penetration point 150 (potentially within the aperture 142). According to some embodiments, the secondary suture 156 extends through the primary suture 144 at each penetration point 150. Alternatively, the secondary suture 156 may extend through only some of the penetration points 150, as will be further disclosed below herein.

[0218] In such embodiments, the primary suture 144 is passed through a pre-formed aperture 142 along the cusp end portion 134, so that the accuracy of the penetration points 150 for the primary suture 144 and / or secondary suture 156 can be preset, leading to more precise suture placement and less error.

[0219] The aperture 142 is sized to receive the primary suture 144. According to some embodiments, the diameter of the aperture 142 is equal to or smaller than the diameter of the primary suture 144, so that each aperture 142 firmly holds the primary suture 144 as it passes through it. Since the secondary suture 156 widens the boundary of the primary suture 144 outward in the penetration zone, alternative embodiments may include an aperture 142 having a diameter equal to or smaller than the combined diameter of the primary suture 144 and the secondary suture 156, so that the aperture 142 firmly holds both of them as the secondary suture 156 extends through the primary suture 144 within the aperture 142.

[0220] According to some embodiments, the cusp end portion 134 includes a marking that can follow an uneven scallop line, for example, by tracking the curvature of the cusp edge portion 135. Such a marking can be used as an alternative to or in addition to the aperture 142, and such a marking can further assist the assembler when sewing the primary suture 144 along it.

[0221] According to some embodiments, as shown in Figure 5E, the secondary suture 156 is passed through all consecutive penetration points 150, so that each self-tightening construct 158 ​​is positioned over a single outer stitch portion 148, and each suture tension portion 164 extends over the length of a single inner stitch portion 146.

[0222] According to alternative embodiments, the secondary suture 156 is not necessarily passed through all consecutive penetration points 150, and in fact, it is possible to skip over one or more penetration points 150, allowing a single suture tension portion 164 to extend over two or more internal stitch portions 146 or external stitch portions 148. Figure 6 shows an exemplary configuration in which each self-tightening construct 158 ​​is positioned over a single external stitch portion 148, while the suture tension portion 164 extends over two internal stitch portions 146 and a single external stitch portion 148 positioned between them. Other configurations are also conceivable in which it is understood that either the self-tightening construct 158 ​​and / or the suture tension portion 164 is passed through non-consecutive penetration points 150.

[0223] The term “non-contiguous penetration points” refers to any set of penetration points that include at least one additional penetration point 150 between them. Advantageously, the self-tightening configuration of the secondary suture 156 allows it to pass through the non-contiguous penetration points 150 while maintaining sufficient grip to prevent or at least significantly reduce lateral movement of the cusp end portion 134 on the strut 110. Thus, the number and position of the self-tightening constructs 158 can be designed and modified in various different ways based on the desired mounting points and to facilitate easier installation by the assembler of the valve 100.

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

[0225] According to some embodiments, the diameter of the aperture 142 is equal to or less than the diameter of the two primary sutures 144, so that each aperture 142 firmly holds both primary sutures 144 when both primary sutures 144 extend through it. Since the secondary suture 156 widens outward the boundary of at least one of the primary sutures 144 in the penetration zone, alternative embodiments may include an aperture 142 having a diameter equal to or less than the combined diameter of the two primary sutures 144 and the secondary suture 156.

[0226] Generally, passing sutures through the valve leaflet 132 involves using a needle or other sharp tool that can puncture the valve leaflet 132. However, the use of a needle or other sharp tool can lead to unintended cuts, punctures, or other damage to the valve leaflet 132. Furthermore, such damage may be difficult for the manufacturer to foresee or predict, and may also be difficult for the end user to detect when it occurs. The primary suture 144 is passed through a penetration point 150 in an in-and-out manner, and the penetration point 150 also serves as the penetration site through which the secondary suture 156 is passed. Thus, since the secondary suture 156 is passed through the primary suture 144 and not directly into the valve leaflet, additional punctures or cuts to the valve leaflet can be avoided. Advantageously, the proposed arrangement allows for the use of the secondary suture 156 to attach the valve leaflet 132 to the strut of the frame without further puncturing the valve leaflet tissue, thereby improving the long-term durability of the valve leaflet.

[0227] A suture pattern including a self-tightening construct 158 ​​for directly attaching the valve leaflet 132 to the strut 110 of the frame 106, according to any of the embodiments described above, can be implemented for any type of artificial valve 100 (e.g., either a mechanically expandable valve 100' or a balloon expandable valve 100''). However, the advantages of the self-tightening construct 158 ​​are more pronounced with respect to the type of mechanically expandable valve 100' illustrated in Figure 1A, which is shown to include intersecting struts 110' of two layers that intersect at the joint 116' (e.g., via a pin or other hinge). A particular challenge associated with such a double-layer frame 106' is the difficulty in forming a suture knot at the pivot joint 116'. This is because the relative movement between the intersecting struts 110' can exert a scissor-like shearing force, which can impair the integrity of the suture in such areas.

[0228] Unlike the double-layer frame 106' of a mechanically expandable valve (e.g., valve 100' shown in Figure 1A), the frame of an artificial valve formed by a unitary frame (e.g., the frame 106'' of a balloon expandable valve 100'' shown in Figure 1B) is not afflicted with this problem in the same sense, and the stitching pattern used to directly connect the valve leaflets 132 to such a frame 106'' may include knots formed around the non-apex joints 116'' in a manner that maintains a secure attachment between the non-apex joints 116'' without necessarily utilizing a self-tightening structure.

[0229] Referring particularly to Figures 9A to 9D, an exemplary technique for connecting the valve leaflets 132 along the cusp end portion 134 to strut sections 111 interconnected at non-apex joints 116 will be discussed here in accordance with this teaching. The diagrams illustrated in Figures 9A to 9D are viewed from a bottom perspective of a section of the prosthetic valve (e.g., a section of the prosthetic valve 100''). As used herein, the strut section 111 refers to any section of the strut defined between two non-apex joints 116 of the frame 106.

[0230] The frame 106'' of an exemplary balloon-expandable valve 100'' illustrated in Figure 1B is shown to include a flat inlet apex 118'' (and similarly a flat outlet apex 120''). In some embodiments, the strut section can be either a relatively straight strut section (e.g., strut section 111''b shown in Figure 1B) extending between two non-apex joints (e.g., non-apex joints 116''b and 116''c) that are spaced axially apart from each other, and / or a curved strut section (e.g., strut section 111''a) extending between two non-apex joints (e.g., non-apex joints 116''a and 116''b) that are spaced laterally apart from each other but can be aligned with each other at the same height between the inlet end 105'' and the outlet end 103''. In such embodiments, the peak of the curvature of the curved strut section can define a vertex (for example, an inflow vertex 118''a defined by the curved strut section 111''a).

[0231] As shown in Figures 9A and 9B, each strut section 111 and each non-vertex joint 116 are defined between opposite axial sides and between opposite radial sides. For example, each strut section 111 is defined between a proximal strut side 190 facing the outlet end 103 and a distal strut side 191 facing the inlet end 105 (sides 190 and 191 are opposite axial sides of the strut section). Also, each strut section 111 is defined between an inner strut side 192 facing the valve longitudinal axis 10 and an outer strut side 193 facing away from the axis 10 (sides 192 and 193 are opposite radial sides of the strut section). As illustrated in the examples in Figures 5A to 6, if the strut has a rectangular cross-sectional profile, then each of the sides 190, 191, 192, and 193 can be defined by the corresponding planar plane of the strut. Nevertheless, as described above, other cross-sectional shapes for the strut are also conceived so that the sides do not necessarily have to include planar planes.

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

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

[0234] As shown in Figures 9A and 9B, the cusp end portion 134 (through which the primary suture 144 is passed in an in-and-out pattern) approximates the strut section 111, and the cusp end portion 134 is preferably positioned radially inward at the inner side portion 192 of the strut (optionally in contact with the inner side portion 192 of the strut). The secondary suture 170 is sewn around the strut section 111 through the primary suture 144 in a manner that forms a series of loops or whipstitches 172 spaced apart from one another along the length of the 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 structure 158, but rather wraps around at least one strut section 111 by a series of whip stitches and includes at least one joint lock knot 174 around at least one non-apex joint 116.

[0235] A whip stitch 172 is formed by passing the secondary suture 170 through the primary suture 144 at the penetration point 150, extending the secondary suture 170 around the strut section 111 and returning it towards the primary suture 144, and then passing the secondary suture 170 once again through the primary suture 144 at a continuous penetration point 150 (at which another whip stitch may be formed in a similar manner).

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

[0237] Passing the whip stitch 172 through a series of penetration points 150 results in a series of angled whip stitches. An angled whip stitch can be defined as a stitch having at least one portion extending between opposite sides of the strut section 111, oriented at an angle not perpendicular to the strut section axis, which is defined as being tangent to the strut section 111 in the region of each stitch.

[0238] In the example illustrated in Figures 9A and 9B, the portion of the whipstitch 172b extending along the outer side 193 of the strut between the proximal side 190 and the distal side 191 of the strut (this portion is hidden from view in Figure 9B), the portion extending along the distal side 191 of the strut between the outer side 193 and the inner side 192 of the strut, and the portion extending along the inner side 192 of the strut between the distal side 191 and the proximal side 190 of the strut (optionally, at least partially over the inner surface 152 of the valve leaflet) are oriented at an angle not perpendicular to the axis of the strut section in contact with the strut 111a in the region of the whipstitch 172b.

[0239] Therefore, each angled whipstitch 172 has a portion that extends over one axial side of the strut section 111 around which it is wrapped, and it is closer to the joint 116 (at the end of each 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 whipstitch 172 extending over the proximal side 190 of the strut section 111a is closer to the joint 116b than the opposite portion that extends over the distal side 191 of the strut. Alternatively, the opposite orientation of the whipstitch 172 can include the portion extending over the distal side 191 of the strut being closer to such joint 116 than the portion extending over the proximal side 190 of the strut. A series of whipstitches 172 wrapped around a single strut section 111 defined between two joints 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 passing the secondary suture 170 through the primary suture 144 does not break or destroy the primary suture 144. The diameter ratio of the secondary suture 170 to the primary suture can be defined in the same manner as described above with respect to the secondary suture 156. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.8. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.5. According to some embodiments, the diameter ratio of the secondary suture to the primary suture is less than 0.3.

[0241] As shown in Figure 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, which is defined as the whip stitch closest to the non-apex joint 116 (joint 116b in Figure 9B) at the end of the strut section 111, the final whip stitch 172n extending to the final penetration point 150n, after which a secondary suture 170 is used to form a joint lock knot 174 over the corresponding non-apex joint 116.

[0242] The joint lock 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 joint 116 in the direction from the first lateral side 198 of joint to the second lateral side 199 of joint. In the example illustrated in Figure 9B, the secondary suture 170 extends over the lateral side 193 of strut section 111a, from the final penetration point 150n in the proximal side 190 of strut to the distal side 191 of strut, adjacent to the first lateral side 198 of joint 116b. Next, the transition section 176 is formed by extending the secondary suture 170 along the distal side 195 of the joint in an oblique direction (for example, radially inward from the outer side 197 of the joint to the inner side 196 of the joint, and laterally from the lateral side 198 of the first joint to the lateral side 199 of the second joint, etc.).

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

[0244] The second loop 180 is formed by passing the tail of the secondary suture 170 from the first loop 178 between the transition section 176 and the joint 116, and then looping it back so that it extends through the first loop 178. In the example illustrated in Figure 9C, the secondary suture 170 (extending from the first loop 178) is passed, for example, axially (e.g., upward toward the outflow end 103), then folded back toward its rear (e.g., distal / downward), and passed through the first loop 178. The tail of the secondary suture is then forcibly pulled to tighten both loops 178, 180 and lock the resulting knot 174.

[0245] The procedure can then be repeated by forming a series of whip stitches 172 to attach the valve leaflet 132 to a subsequent strut section 111 (e.g., strut section 111b) extending from the joint 116, and by forming similar joint lock knots 174 over each respective joint 116 along the path of the rounded cusp end portion 134. Advantageously, this type of stitching pattern facilitates the valve assembly procedure because the knots 174 around the joint 116 maintain a firm connection between the valve leaflet and the joint during assembly.

[0246] Compared to conventional assembly procedures (during which the assembler is required to maintain tension on the sutures while forming each subsequent stitch along the entire perimeter of the frame), the joint lock knot 174 maintains a secure connection of all the 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 undone.

[0247] The firm connection of the knot 174 also keeps all the whip stitches 172 along the strut section 111 connected to it firmly 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] Furthermore, any joint lock knot 174 separates a series of whip stitches 172 around the strut sections 111 extending from both sides of the joint 116. Thus, the orientation of the angled whip stitches 172 formed following the joint lock knot 174 does not depend on the configuration of the whip stitches 172 leading to the knot 174, and in fact can have similar or different angle orientations, and similar or different stitching densities, etc. This allows the assembler to switch the angle orientation of the angled whip stitches, which are sewn in any desired direction that may be convenient during the assembly procedure (which may differ with respect to different strut sections 111 along the periphery of the valve 100).

[0249] Figure 10 shows an example of a portion of a leaflet assembly 130 sutured to a frame 106 (the figure is from the inside of the valve). As illustrated, the procedure may be repeated to attach one or more other leaflets 132 to the strut section 111 and joint 116, including the formation of a similar joint lock knot 174 around a joint 116 that interconnects two adjacent leaflets 132 (for example, joint 116d aligned with the crossover 140 between leaflets 132a and 132b shown in Figure 10).

[0250] In the illustrated diagram, the cusp end portion of leaflet 132a is sutured to strut sections 111a, 111b, and 111c, and the cusp end portion of leaflet 132b is sutured to strut sections 111d, 111e, and 111f. As shown, the angular orientation of the whipstitches 172 around strut sections 111a, 111b, and 111c is generally similar (for example, their upper / proximal ends are closer to the joint 116d than their lower / distal ends). After the joint lock knot 174 around joint 116d, the orientation of the whipstitch 172 around strut sections 111d and 111e is generally reversed in the opposite direction, and as shown, after the joint lock knot 174 around joint 116f, the orientation of the whipstitch 172 around strut section 111f is switched again (to an orientation similar to that of the whipstitch looped over strut sections 111a-c). The ability to independently change the orientation of the whipstitch wrapped around each strut segment makes it possible to expedite the valve assembly process.

[0251] In some cases, it may be preferable to attach the valve leaflet 132 to the frame 106 using a secondary suture 156 that does not penetrate the valve leaflet 132 and / or the primary suture 144. Figures 11A–11D show exemplary techniques for connecting the valve leaflet 132 to the strut section 111 along its cusp end portion 134. The diagrams illustrated in Figures 11A–11D are viewed from a bottom view of a section of the prosthetic valve (e.g., a section of the prosthetic valve 100''), similar to the viewing angles in Figures 9A–9D.

[0252] The primary suture 144 may be passed through the cusp end portion 134 in an in-and-out pattern in the same manner as described above in relation to Figure 4, and it may form multiple running stitch portions, which include an internal stitch portion (hidden from view) extending over the internal surface of the valve leaflet and an external stitch portion 148 (e.g., external stitch portions 148a, 148b, and 148c shown in Figure 11A) extending over the external surface of the valve leaflet 154 between the penetration points 150. In some embodiments, two primary sutures 144a and 144b are passed through the penetration points 150 in opposite directions in a similar manner to that described above in relation to Figure 8. Thus, any reference to the primary suture described below in relation to Figures 11A to 11D may refer to a configuration of either a single primary suture or two sutures passed in opposite directions with equal force.

[0253] As shown in Figure 11A, the cusp end portion 134 (through which the primary suture 144 is passed in an in-and-out pattern) approximates the strut section 111, and the cusp end portion 134 is preferably positioned radially inward at the inner side portion 192 of the strut (optionally in contact with the inner side portion 192 of the strut). The secondary suture 170 is looped around the outer stitch portion 148 of the primary suture 144 and around the strut section 111, in a manner that forms a series of non-penetrating whip stitches 182 spaced apart from one another along the length of the strut section 111. The secondary suture 170 in the embodiments shown in Figures 11A to 11D can be the same as in any embodiment described above in relation to Figures 9A to 9D, except that the secondary suture 170 in the embodiments shown in Figures 11A to 11D is used to form a non-penetrating whip stitch 182 instead of a conventional whip stitch 172 that extends from one side of the valve leaflet to the other (for example, from the inner surface 152 of the valve leaflet to its outer surface 154).

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

[0255] For example, Figure 11A shows two non-penetrating whipstitches 182a and 182b, which include a corresponding strut-wrapped section 184 and a corresponding primary suture-wrapped section 186, respectively. The subsequent non-penetrating whipstitch 182c is formed, as shown in Figure 11B, by looping the tail of the secondary suture 170, which extends from the primary suture-wrapped section 186b (looped around the outer stitch portion 148b), around the strut section 111 and returning it toward the subsequent stitch portion 148c of the primary suture 144.

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

[0257] As further shown in Figure 11B, the secondary suture 170 is then passed under the continuous outer stitch portion 148c between the outer stitch portion and the valve leaflet 132 (i.e., between the outer stitch portion 148 and the inner surface 152 of the valve leaflet). As shown in Figure 11C, the secondary suture 170 is then folded over the outer stitch portion 148c, thereby forming the primary suture wrap section 186c. The suture is then able to pass across the strut section 111 (for example, across the outer side portion 193 of the strut and toward the distal side portion 191 of the strut in the example illustrated in Figure 11C), and these steps are repeated to form a subsequent non-penetrating whip stitch 182 (for example, a non-penetrating whip stitch 182d).

[0258] As shown in Figure 11D, this procedure may be repeated until the final non-penetrating whip stitch 182n, which is defined as the whip stitch closest to the non-vertex joint 116 at the end of the strut section 111, and the secondary suture 170 may be used to form the joint lock knot 174 in accordance with the same steps described above in relation to Figures 9A-9D, except that the transition zone 176 of the joint lock knot 174 extends from the final primary suture wrap section 186n of the final non-penetrating whip stitch 182n instead of extending from the final penetration point 150n.

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

[0260] Figure 13 shows another stitching configuration similar to those shown in Figures 12A–12D, except that two non-penetrating whipstitches 182 pass through their respective outer stitch portions 148. In the illustrated example, the non-penetrating whipstitch 182a' includes a strut-wrapped section 184a' that loops around the strut section 111 and a primary suture-wrapped section 186a', the primary suture-wrapped section 186a' extending from the strut-wrapped section 184a' and looping around the outer stitch portion 148a. The secondary suture 170 then extends to form the strut-wrapped section 184a'' of the non-penetrating whipstitch 182a'' and the primary suture-wrapped section 186a' that loops around the same outer stitch portion 148a.

[0261] Subsequently, the secondary suture 170 extends to form subsequent non-penetrating whip stitches 182b' and 182b'' in a similar manner, so that their primary suture-wrapped sections 186b' and 186b'' are looped around the outer stitch portion 148b. Although two non-penetrating whip stitches 182 passing through a single outer stitch portion 148 are illustrated in Figure 13, it should be understood that any other number of non-penetrating whip stitches 182 can pass through any single outer stitch portion 148 in a similar manner.

[0262] Figure 14 shows yet another stitching configuration, which is similar to those shown in Figures 12A–12D, except that each non-penetrating whipstitch 182 further includes a strut loop section 185 extending from each primary suture wrap section 186, and the strut loop section 185 is looped only over the strut section 111. In the illustrated example, the non-penetrating whipstitch 182a includes a strut wrap section 184a, a primary suture wrap section 186a, and a strut loop section 185a, where the strut wrap section 184a is looped around the strut section 111, the primary suture wrap section 186a extends from the strut wrap section 184a and is looped around the outer stitch portion 148a, and the strut loop section 185a extends from the primary suture wrap section 186a and is again looped around the strut section.

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

[0264] The configuration described above and illustrated in FIGS. 11A-14 showing the primary suture thread wound section 186 looped around the outer stitch portion 148 is understood to be non-binding and that any primary suture thread wound section 186 can be looped around any running stitch portion (including around the inner stitch portion 146 of the primary suture thread 144). In some embodiments, the cusp end portion 134 can be folded back onto itself such that the cusp edge 135 is placed on the outer cusp tip surface 152 facing outward and the outer stitch portion 148 is hidden and the inner stitch portion 146 faces the strut section 111. In such embodiments, the non-penetrating whip stitch can be formed in the same manner as described above except that the secondary suture thread is looped around the inner stitch portion 146 instead of around the outer stitch portion.

[0265] It should be understood that various suturing configurations can be combined to attach one or more cusp tips 132 to the strut section 111 of the same prosthetic valve 100. For example, attaching the cusp tip 132 along its rounded cusp end portion 134 to one or more strut sections 111 can include one or more single non-penetrating whip stitches 182 passing through the corresponding running stitch portion (as shown in FIGS. 12A-12D), one or more double non-penetrating whip stitches 182 passing through the corresponding single running stitch portion (as shown in FIG. 13), and / or one or more single non-penetrating whip stitches 182 looped twice around the strut section 111 (as shown in FIG. 14). The single pattern or composite pattern configurations can be implemented along the same strut section 111 or around different strut sections of the same valve.

[0266] Attaching the valve leaflets 132 to the frame 106 (more specifically to the strut section 111 of the frame 106) by non-penetrating whip stitches 182 is advantageous because it reduces damage to the valve leaflet material resulting from the fact that secondary sutures 170 do not need to penetrate the tissue material, thereby improving the long-term durability of the valve leaflets and their attachment to the frame along the scalloped line.

[0267] Non-penetrating whipstitches 182 (with or without joint lock knots 174) are described and illustrated above with respect to the attachment of the valve leaflets 132 to the frame 106, but such attachment configurations may also be used for the attachment of other soft components of the valve 100 to the frame 106, such as a skirt 123 which may include either an inner skirt (not shown) or an outer skirt 124.

[0268] Figure 15 shows an artificial valve 100 with an outer skirt 124 according to several embodiments. The artificial valve can be similar in all respects to the artificial valve 100'' described in relation to Figure 1B, and for the sake of brevity, will not be described further. The skirt 123 (e.g., the outer skirt 124 shown in Figure 15) extends between the proximal end 129 and the distal end 128 of the skirt and defines an inner skirt surface 125 facing (and at least partially in contact with) the frame 106 and an outer skirt surface 126 facing away from the frame (towards the natural anatomical structure when implanted in the patient's body).

[0269] In some embodiments, as further shown in Figure 15, the proximal end of the outer skirt follows a zigzag pattern, corresponding to the zigzag pattern of the strut section 111 to which it may be sutured. In certain exemplary embodiments illustrated in Figure 15, the distal end 128 of the skirt is substantially linear (for example, straight when the skirt is flattened), meaning that it is held at the same axial level and circumferentially arranged around the inlet end portion 104 of the valve 100.

[0270] In some embodiments, one or more primary sutures 144 are sutured 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 one or more secondary sutures 170 form a plurality of non-penetrating whipstitches 182 to connect the skirt 123 to the strut section 111 of the frame 106.

[0271] The primary suture 144 can be sewn through the skirt 123 in an in-and-out pattern, with modifications where appropriate, according to any of the embodiments disclosed herein. Similarly, any type of non-penetrating whipstitch 182 disclosed above with respect to the attachment of the valve leaflet 132 to the strut 111 can also be adapted, with modifications where appropriate, to attach the skirt 123 to the strut 111 in the same manner.

[0272] Figure 16 shows a partial view of the outer skirt 124 connected to the strut 111 of the frame 106 of the valve 100 shown in Figure 15, from a valve-internal viewing angle. The valve leaflet assembly 130 is omitted from the figure in Figure 16 for simplicity. In the illustrated exemplary embodiment, the primary suture 144 is sewn in an in-and-out pattern along the proximal end 129 of the skirt, for example, following its zigzag shape. In the case of the outer skirt 124, the primary suture 144 can define a series of running stitch portions including an inner stitch portion 146 and an outer skirt portion 148, the inner stitch portion 146 being positioned on the inner surface 125 of the skirt and the outer skirt portion 148 being positioned on the outer surface 126 of the skirt. Next, multiple non-penetrating whip stitches 182 are looped around the strut section 111 via the strut-wrapped section 184, and also looped around the running stitch portion of the primary suture 144 (for example, on the inner stitch portion 146 and the inner surface 125 of the skirt, and between the inner stitch portion 146 and the inner surface 125 of the skirt).

[0273] Certain embodiments of the non-penetrating whipstitch 182, similar to those described in relation to Figures 12A to 12D, are illustrated in Figure 16, for example, along strut sections 111m, 111n, 111o, and 111p. However, it should be understood that the skirt can be sutured to the corresponding strut section 111 by implementing any of the suture patterns and methods described above in relation to Figures 11A to 14, with modifications where necessary.

[0274] In some embodiments, joint lock knots 174 are also used to attach a skirt 123 (e.g., an outer skirt 124) to a joint 116 located between strut sections 111 to which the skirt is sewn via a non-penetrating whip stitch 182, such as joint lock knots 174m, 174n, 174o, 174p, and 174q formed on each of the joints 116m, 116n, 116o, 116p, and 116q in the illustrated example. The configuration and method for forming such joint lock knots 174 are similar to those described above with respect to the attachment of the valve leaflets 132 to the joint 116, with modifications where appropriate.

[0275] In some embodiments, the skirt 123 (e.g., the outer skirt 124) is connected to additional joints 116 (which are not necessarily located between strut sections 111 around which non-penetrating whipstitches 182 extend) via additional knots, and the additional knots are not necessarily joint lock knots 172, but can also be implemented as other knots known in the art, for example, with respect to knots 166r, 166s, and 166t around each joint 116r, 116s, and 116t, as schematically shown in Figure 16.

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

[0277] Figure 18 shows a partial view of the outer skirt 124 connected to the strut 111 of the frame 106 of the valve 100 shown in Figure 17, from a valve-bottom-internal viewing angle. The valve leaflet assembly 130 is omitted from the figure in Figure 18 for simplicity. In the illustrated exemplary embodiment, the primary suture 144 is sewn in an in-and-out pattern along the distal end 128 of the skirt, for example, following its undulating shape. In addition to the primary suture 144, it may be sewn along the proximal end 129 of the skirt, which is implemented in the same manner as described above.

[0278] Subsequently, multiple non-penetrating whip stitches 182 are looped around the strut section 111 (of the inlet end portion 104) by a series of strut-wrapping sections 184, and also looped around the running stitch portion of the primary suture 144 (for example, on the inner stitch portion 146 and the inner surface 125 of the skirt, and between the inner stitch portion 146 and the inner surface 125 of the skirt). Specific embodiments of the non-penetrating whip stitches 182, similar to those described in relation to Figures 12A to 12D, are illustrated in Figure 18, for example, along strut sections 111u and 111w, but it should be understood that the skirt can be sutured to the corresponding strut section 111 by implementing any of the suture patterns and methods described above in relation to Figures 11A to 14, with modifications where appropriate.

[0279] In some embodiments, joint lock knots 174 are also used to attach the outer skirt 124 along the inlet end portion 104 to the joint 116, with modifications where appropriate, in accordance with the same configuration and method described above with respect to the attachment of the valve leaflets 132 to the joint 116, such as joint lock knots 174r, 174s, and 174t formed around each of the joints 116r, 116s, and 116t in the illustrated example.

[0280] In some embodiments, the skirt 123 (e.g., outer skirt 124) is attached in the same manner and according to all optional embodiments described above to an additional strut section 111 disposed between the proximal end 129 and the distal end 128 of the skirt via a non-penetrating whip stitch 182. For example, one or more primary sutures 144 may be sewn in an in-and-out pattern along the area of ​​the skirt that is aligned with the strut section 111 disposed between the proximal end 129 and the distal end 128 of the skirt (when the skirt is attached to the frame), which is implemented according to any embodiment of sewing such primary sutures 144 as described above. A series of non-penetrating whipstitches 182 (implemented according to any of the embodiments described above with respect to Figures 11A to 14) can be used, for example, to attach the skirt to the corresponding strut section 111 along strut sections 111r, 111s, 111t, and 111v, as shown in Figure 18.

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

[0282] Some valves are provided with an inner skirt (not shown) arranged around the inner surface of the frame. The outer skirt 124 is illustrated throughout Figures 15–18 to demonstrate its various mounting configurations to the frame, but it should be understood that the same embodiments described above with respect to the outer skirt mounting can be implemented in a similar manner with respect to the mounting of the inner skirt to the frame, with modifications where necessary.

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

[0284] For example, the skirt may be sutured in the same manner, with modifications where necessary, and in a similar manner to those described above in Figures 10A to 11 with respect to the attachment of the valve leaflets 132 to the frame 106, via a series of whip stitches 172 to the corresponding strut section 111 along either the proximal end 129 or the distal end 128 of the skirt, and / or to the strut section 111 located between the proximal end 129 and the distal end 128 of the skirt (when the skirt is attached to the frame), with the series of whip stitches 172 being able to pass through the primary suture 144, with a joint lock knot 174 formed around the joint 116 located between such strut sections 111.

[0285] Additional examples of the disclosed technology In consideration of the above-described implementations of the disclosed subject matter, this application discloses the additional embodiments listed below. It should be noted that one feature of an isolated embodiment, or two or more features of that embodiment combined, and optionally two or more features of that embodiment combined with one or more features of one or more further embodiments, are also further embodiments that fall within the disclosure of this application.

[0286] Example 1. An artificial valve, wherein the artificial valve is A frame movable between a radially compressed configuration and a radially expanded configuration, the frame including a plurality of intersecting struts, the frame, and A valve leaflet assembly, the valve leaflet assembly being mounted within the frame and including a plurality of valve leaflets configured to regulate flow through the prosthetic valve, each valve leaflet including a rounded cusp end portion, the 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, the valve leaflet assembly, and comprising, 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 passed in an in-and-out pattern through the cusp end portion at a penetration point, the secondary suture being passed around at least one section of at least one strut through the primary suture, the secondary suture including a plurality of self-ligating constructs, each self-ligating construct including at least one loop configured to contract around the strut under tension. A prosthetic valve.

[0287] Example 2. The prosthetic valve according to any of the examples described herein, particularly the prosthetic valve described in Example 1, wherein at least one loop of each self-ligating construct includes two loops.

[0288] Example 3. The prosthetic valve according to any of the examples described herein, particularly the prosthetic valve described in Example | or 2, wherein each self-ligating construct further includes a U-shaped section that extends partially between at least one loop and the strut.

[0289] Example 4. An artificial valve according to any embodiment herein, in particular any one of Examples 1 to 3, wherein the valve leaflet includes an inner surface and an outer surface, and the primary suture includes a plurality of inner stitch portions arranged along the inner surface of the valve leaflet and a plurality of outer stitch portions arranged along the outer surface of the valve leaflet, each inner stitch portion and each outer stitch portion defined between their respective penetration points.

[0290] Example 5. The self-tightening structure is defined between two through points that define at least one outer stitch portion, as described in any embodiment herein, in particular, as described in Example 4.

[0291] Example 6. An artificial valve according to any embodiment herein, in particular, the one described in Example 4 or 5, wherein the secondary suture further includes a plurality of suture tension portions extending over the inner surface of the valve leaflet.

[0292] Example 7. An artificial valve according to any embodiment of this specification, in particular, the one according to Example 6, wherein at least one of the suture-tensioned portions extends over two or more internal or external stitch portions.

[0293] Example 8. An artificial valve according to any embodiment of this specification, particularly Example 6 or 7, wherein the suture tension portion is pressed against at least one primary suture portion.

[0294] Example 9. An artificial valve according to any example described herein, in particular any one of Examples 1 to 8, wherein the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0295] Example 10. An artificial valve described in any example herein, in particular in Example 9, in which the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.8.

[0296] Example 11. An artificial valve described in any example herein, in particular in Example 9, in which the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

[0297] Example 12. An artificial valve described in any example herein, in particular in Example 9, in which the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.3.

[0298] Example 13. An artificial valve according to any embodiment described herein, in particular any one of Examples 1 to 12, wherein the cusp end portion of each valve leaflet includes a series of pre-formed apertures.

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

[0300] Example 15. An artificial valve according to any embodiment described herein, in particular, Example 13 or 14, wherein the apertures are arranged at equal intervals from one another.

[0301] Example 16. An artificial valve according to any embodiment described herein, in particular 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. An artificial valve according to any embodiment described herein, in particular 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 artificial valve described in any embodiment described herein, in particular any one of Examples 1 to 17, wherein the secondary suture is passed through all consecutive penetration points.

[0304] Example 19. An artificial valve according to any embodiment described herein, in particular any one of Examples 1 to 18, wherein at least one primary suture comprises two primary sutures, the two primary sutures being passed in opposite directions in an in-and-out pattern through the same penetration point.

[0305] Example 20. An artificial valve according to any embodiment described herein, in particular any one of Examples 13 to 15, wherein the diameter of the aperture is equal to or less than the diameter of the two primary sutures.

[0306] Example 21. An artificial valve described in any example herein, in particular in 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. An artificial valve according to any embodiment described herein, in particular 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 primary suture is a multifilament suture, as described in any example herein, in particular, as described in any one of Examples 1 to 22.

[0309] Example 24. The secondary suture is an artificial valve according to any example described herein, in particular, one of Examples 1 to 23, comprising ultra-high molecular weight polyethylene.

[0310] Example 25. An artificial valve, as described in any embodiment herein, in particular, as described in any one of Examples 1 to 24, wherein the artificial valve lacks a fabric strip and / or cloth between the cusp end portions of the valve leaflets and the strut to which they are attached.

[0311] Example 26. A method for assembling an artificial valve, The steps include passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include: approximating the cusp end portion through which the primary suture passes to at least one strut of the artificial valve frame; A step of sewing a secondary suture through a primary suture and around at least one strut in a manner that forms a plurality of self-tightening structures, wherein each self-tightening structure is formed to include at least one loop configured to contract around a strut under tension, Methods that include...

[0312] Example 27. The method according to any embodiment described herein, in particular Example 26, wherein the step of sewing in a secondary suture includes passing the secondary suture radially outward through the primary suture at the penetration point, thereby forming at least one loop around at least one strut.

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

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

[0315] Example 30. The method according to any embodiment described herein, in particular any one of Examples 26 to 29, further comprising the steps of extending a secondary suture over the inner surface of the valve leaflet, and then passing the primary suture through the secondary suture again in a radially outward direction, thereby forming at least one suture tension portion extending over the inner surface of the valve leaflet.

[0316] Example 31. The method according to any embodiment described herein, in particular any one of Examples 26 to 30, wherein the cusp end portion of each valve leaflet includes a series of pre-formed apertures, and the step of passing a primary suture includes passing the primary suture through the series of pre-formed apertures in an in-and-out pattern.

[0317] Example 32. An artificial valve, A frame that is movable between a radially compressed configuration and a radially expanded configuration, the frame comprising a plurality of strut sections that intersect at a joint, A valve leaflet assembly comprising a plurality of leaflets, which are mounted within a frame and configured to regulate flow through an artificial valve, each leaflet comprising a rounded cusp end portion, the 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, Includes, Each joint is defined between two opposite axial sides, including the proximal and distal sides of the joint; between two opposite radial sides, including the inner and outer sides of the joint; and between two opposite lateral sides, including the lateral side of the first joint and the lateral side of the second joint; Each cusp end portion is connected to at least one strut section via at least one primary and secondary suture, the at least one primary suture passing through the cusp end portion in an in-and-out pattern at the penetration point, and the secondary suture passing through the primary suture and wrapped around the strut section in a series of whip stitches spaced apart from each other along the length of the strut section; An artificial valve, wherein the cusp end portion is further connected to at least one joint at the end of the strut section via a joint lock knot formed by a second suture, the joint lock knot being configured to maintain tension on a plurality of whip stitches wrapped around the corresponding strut section leading to the lateral side of the first joint.

[0318] Example 33. Each joint lock knot is: A transition section extending over one axial side of the joint, from the lateral side of the first joint to the lateral side of the second joint; A first loop, the first loop extending from the transition section and extending around a strut section extending from the lateral side of the second joint; A second loop, the second loop extending from the first loop between the transition section and the junction, and folding back over itself so as to extend through the first loop, Artificial valves as described in any embodiment herein, in particular as the one described in Example 32.

[0319] Example 34. The transition section extends obliquely 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, as described in any embodiment herein, in particular, as described in Example 33.

[0320] Example 35. An artificial valve according to any embodiment described herein, in particular, Example 33 or 34, wherein both the first loop and the second loop are tightly tensioned around the joint.

[0321] Example 36. An artificial valve according to any embodiment described herein, in particular, one of any one of Examples 32 to 35, wherein each of the multiple whipstitches wrapped around a single strut section is an angled whipstitch oriented in the same direction along the length of the corresponding strut section.

[0322] Example 37. The cusp end portion is sutured to at least two strut sections extending from both lateral sides of a selected joint, via a plurality of whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of whip stitches around one of the strut sections are angled in the opposite direction to those of the plurality of whip stitches wrapped around the other strut section, as described in any embodiment herein, in particular, as described in Example 36.

[0323] Example 38. An artificial valve according to any example described herein, in particular 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. An artificial valve described in any example herein, in particular in 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. An artificial valve described in any example herein, in particular in Example 38, wherein the diameter ratio of the secondary suture to the primary suture is equal to or less than 0.5.

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

[0327] Example 42. An artificial valve according to any embodiment described herein, in particular any one of Examples 32 to 41, wherein the cusp end portion of each valve leaflet includes a series of pre-formed apertures.

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

[0329] Example 44. The apertures are arranged at equal intervals from one another, as described in any embodiment herein, in particular in Example 42 or 43.

[0330] Example 45. An artificial valve according to any embodiment described herein, in particular any one of Examples 42 to 44, wherein the diameter of the aperture is equal to or less than the diameter of the primary suture.

[0331] Example 46. An artificial valve according to any example described herein, in particular 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. An artificial valve according to any embodiment described herein, in particular any one of Examples 32 to 46, wherein at least one primary suture comprises two primary sutures, the two primary sutures being passed in opposite directions in an in-and-out pattern through the same penetration point.

[0333] Example 48. An artificial valve according to any embodiment described herein, in particular any one of Examples 42 to 44, wherein the diameter of the aperture is equal to or less than the diameter of the two primary sutures.

[0334] Example 49. An artificial valve according to any embodiment described herein, in particular 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. An artificial valve according to any embodiment described herein, in particular 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 primary suture is a multifilament suture, as described in any example herein, in particular, as described in any one of Examples 32 to 50.

[0337] Example 52. The secondary suture is an artificial valve according to any example described herein, in particular, any one of Examples 32 to 51, comprising ultra-high molecular weight polyethylene.

[0338] Example 53. An artificial valve, as described in any embodiment herein, in particular, as described in any one of Examples 32 to 52, lacking a fabric strip and / or cloth between the cusp end portions of the valve leaflets and the strut section and joint to which they are attached.

[0339] Example 54. A method for assembling an artificial valve, The steps include passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include: approximating the cusp end portion through which the primary suture passes to at least one strut section of the artificial valve frame; The process involves the steps of sewing a secondary suture through a primary suture and around at least one strut section, in a manner that forms multiple whip stitches wrapped around the strut section up to the final whip stitch; A step of forming a joint lock knot extending from the final whip stitch around the joint at each end of the corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint, Methods that include...

[0340] Example 55. The method according to any embodiment described herein, in particular Example 54, wherein the step of forming a joint lock knot includes extending a secondary suture from a final whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

[0343] Example 58. The method according to any embodiment described herein, in particular Example 57, wherein the step of forming a joint lock knot further includes the step of forcibly pulling the tail of the second loop and tightening both the first loop and the second loop around the joint.

[0344] Example 59. The method according to any embodiment described herein, in particular any one of Examples 55 to 58, wherein the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0345] Example 60. The method according to any embodiment described herein, in particular any one of Examples 54 to 59, wherein the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

[0346] Example 61. The method according to any embodiment herein, in particular 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 each other by a joint, such that all whip stitches around one strut section are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

[0347] Example 62. The method according to any embodiment described herein, in particular any one of Examples 54 to 61, wherein the cusp end portion of each valve leaflet includes a series of pre-formed apertures, and the step of passing a primary suture includes passing the primary suture through the series of pre-formed apertures in an in-and-out pattern.

[0348] Example 63. An artificial valve, A frame that is movable between a radially compressed configuration and a radially expanded configuration, the frame comprising a plurality of strut sections that intersect at a joint, A valve leaflet assembly comprising a plurality of valve leaflets, which are mounted within a frame and configured to regulate flow through an artificial valve, each leaflet comprising a rounded cusp end portion, the 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, Includes, 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 passing through the cusp end portion in an in-and-out pattern, the secondary sutures forming a series of non-penetrating whip stitches spaced apart from each other 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, looping around the primary suture, and passing between the primary suture and the valve leaflet, an artificial valve.

[0349] Example 64. An artificial valve according to any embodiment herein, in particular, as described in Example 63, wherein the primary suture defines a series of running stitch portions, and each primary suture wrap section is looped around the corresponding running stitch portion and extends between the running stitch portion and the rounded cusp end portion.

[0350] Example 65. An artificial valve according to any embodiment described herein, particularly Example 63 or 64, wherein the secondary suture does not penetrate the valve leaflet.

[0351] Example 66. An artificial valve according to any example described herein, in particular any one of Examples 63 to 65, wherein the secondary suture does not penetrate the primary suture.

[0352] Example 67. Each joint is defined between two opposite axial sides including the proximal and distal sides of the joint; between two opposite radial sides including the medial and lateral sides of the joint; and between two opposite lateral sides including the first and second lateral sides of the joint; the cusp end portion is further connected to at least one joint at the end of the strut section via a joint lock knot formed by a second suture, the joint lock 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 side of the joint, as described in any embodiment herein, in particular, as described in any one of Examples 63 to 66.

[0353] Example 68. Each joint lock knot is: A transition section extending over one axial side of the joint, from the lateral side of the first joint to the lateral side of the second joint; A first loop, the first loop extending from the transition section and extending around a strut section extending from the lateral side of the second joint; A second loop, the second loop extending from the first loop between the transition section and the junction, and folding back over itself so as to extend through the first loop, Artificial valves as described in any embodiment herein, in particular as the one described in Example 67.

[0354] Example 69. An artificial valve according to any embodiment herein, in particular Example 68, wherein the transition section extends obliquely 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. An artificial valve according to any embodiment described herein, in particular, Example 68 or 69, wherein both the first loop and the second loop are tightly tensioned around the joint.

[0356] Example 71. An artificial valve according to any embodiment described herein, in particular, one of Examples 67 to 70, wherein each of the multiple 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. The cusp end portion is sutured to at least two strut sections extending from both lateral sides of a selected joint, via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of non-penetrating whip stitches around one of the strut sections are angled in the opposite direction to those of the plurality of non-penetrating whip stitches wrapped around the other strut section, as described in any embodiment herein, in particular, as described in Example 71.

[0358] Example 73. An artificial valve according to any embodiment described herein, in particular any one of Examples 63 to 72, wherein at least one primary suture comprises two primary sutures, the two primary sutures being passed in reverse in an in-and-out pattern.

[0359] Example 74. An artificial valve according to any embodiment described herein, in particular 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 primary suture is a multifilament suture, the artificial valve described in any example herein, in particular, the one described in any one of Examples 63 to 74.

[0361] Example 76. The secondary suture is an artificial valve according to any example described herein, in particular, any one of Examples 63 to 75, comprising ultra-high molecular weight polyethylene.

[0362] Example 77. An artificial valve, as described in any embodiment herein, in particular, as described in any one of Examples 63 to 76, lacking a fabric strip and / or cloth between the cusp end portions of the valve leaflets and the strut section to which they are attached.

[0363] Example 78. A method for assembling an artificial valve, The steps include passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include: approximating the cusp end portion through which the primary suture passes to at least one strut section of the artificial valve frame; A step of looping a secondary suture around at least one strut section and around a primary suture, in a manner that forms multiple non-penetrating whipstitches wrapped around a strut section up to a final non-penetrating whipstitch, wherein each non-penetrating whipstitch includes a strut-wrapping section and a primary suture-wrapping section, the strut-wrapping section being looped around the strut section, and the primary suture-wrapping section extending from the strut-wrapping section, passing between the primary suture and the valve leaflet, and being looped around the primary suture, and Methods that include...

[0364] Example 79. The method according to any embodiment herein, in particular Example 78, wherein the step of forming each non-penetrating whip stitch includes forming a strut wrap section by extending a secondary suture across one radial side of the strut section, folding it over the axial side of the strut section, and extending it rearward across the opposite radial side of the strut section.

[0365] Example 80. The method according to any embodiment described herein, particularly Example 79, wherein the step of forming each non-penetrating whip stitch further includes the step of 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 over the running stitch portion to form a primary suture wrap section.

[0366] Example 81. The method according to any embodiment described herein, particularly Example 79, wherein the step of forming each non-penetrating whip stitch further includes the step of passing the 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 wrap section.

[0367] Example 82. The method according to any embodiment described herein, in particular Example 80 or 81, wherein the running stitch portion is the outer stitch portion of the primary suture.

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

[0369] Example 84. The method according to any embodiment herein, in particular Example 83, wherein the step of forming a joint lock knot includes extending a secondary suture from a final non-penetrating whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0373] Example 88. The method according to any embodiment described herein, in particular any one of Examples 84 to 87, wherein the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

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

[0375] Example 90. The method according to any embodiment herein, in particular 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 each other by an interlocking portion, such that all whip stitches around one strut section are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

[0376] Example 91. An artificial valve, A frame that is movable between a radially compressed configuration and a radially expanded configuration, the frame comprising a plurality of strut sections that intersect at a joint, A valve leaflet assembly comprising a plurality of leaflets, which are mounted within a frame and configured to regulate the flow through an artificial valve, A skirt arranged around a frame, the skirt including a proximal end and a distal end, Includes, Each joint is defined between two opposite axial sides, including the proximal and distal sides of the joint; between two opposite radial sides, including the inner and outer sides of the joint; and between two opposite lateral sides, including the lateral side of the first joint and the lateral side of the second joint; The proximal end of the skirt is connected to at least one strut section via at least one primary and secondary suture, the at least one primary suture passing through the proximal end of the skirt in an in-and-out pattern at the penetration point, and the secondary suture passing through the primary suture and wrapped around the strut section in a series of whip stitches spaced apart from each other along the length of the strut section; The proximal end of the skirt is further connected to at least one joint at the end of the strut section via a joint lock knot formed by a second suture, the joint lock knot being configured to maintain tension on a plurality of whip stitches wrapped around the corresponding strut section leading to the lateral side of the first joint, the artificial valve.

[0377] Example 92. The proximal end of the skirt follows a zigzag pattern, as described in any embodiment herein, in particular, as described in Example 91.

[0378] Example 93. An artificial valve as described in any embodiment herein, in particular as Example 92, wherein at least one primary suture tracks the zigzag pattern of the proximal end of the skirt.

[0379] Example 94. Each joint lock knot is: A transition section extending over one axial side of the joint, from the lateral side of the first joint to the lateral side of the second joint; A first loop, the first loop extending from the transition section and extending around a strut section extending from the lateral side of the second joint; A second loop, the second loop extending from the first loop between the transition section and the junction, and folding back over itself so as to extend through the first loop, Artificial valves, including those described in any embodiment herein, particularly those described in any one of Examples 91 to 93.

[0380] Example 95. An artificial valve according to any embodiment herein, in particular Example 94, wherein the transition section extends obliquely 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. An artificial valve according to any embodiment described herein, in particular, Example 94 or 95, wherein both the first loop and the second loop are tightly tensioned around the joint.

[0382] Example 97. An artificial valve according to any embodiment described herein, in particular, one of any one of Examples 91 to 96, wherein each of the multiple whipstitches wrapped around a single strut section is an angled whipstitch oriented in the same direction along the length of the corresponding strut section.

[0383] Example 98. The proximal end of the skirt is sutured to at least two strut sections extending from both lateral sides of a selected joint, via a plurality of whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of whip stitches around one of the strut sections are angled in the opposite direction to those of the plurality of whip stitches wrapped around the other strut section, as described in any embodiment herein, in particular, as described in Example 97.

[0384] Example 99. An artificial valve according to any embodiment herein, in particular any one of Examples 91 to 98, wherein the distal end of the skirt is connected to at least one strut section at the inlet 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 through the inlet end portion in an in-and-out pattern at a penetration point, the additional secondary suture being passed through the primary suture and wrapped around the strut section at the inlet end portion in a series of whip stitches spaced apart from each other along the length of the strut section, and the distal end of the skirt is further connected to at least one joint at the end of the strut section at the inlet end portion via an additional joint lock knot.

[0385] Example 100. An artificial valve described in any embodiment herein, in particular, as described in Example 99, wherein an additional primary suture is arranged around the inlet end portion to track the shape of the strut section.

[0386] Example 101. An artificial valve according to any example described herein, in particular 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. An artificial valve according to any example described herein, in particular 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. An artificial valve described in any example herein, in particular in 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. An artificial valve according to any example described herein, in particular 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 proximal end of the skirt comprises a series of pre-formed apertures, as described in any embodiment herein, in particular, as described in any one of Examples 91 to 104.

[0391] Example 106. An artificial valve described in any embodiment herein, particularly Example 105, wherein the aperture is sized to receive at least one primary suture, thereby serving as a penetration point.

[0392] Example 107. An artificial valve according to any embodiment described herein, in particular, Example 105 or 106, wherein the apertures are arranged at equal intervals from one another.

[0393] Example 108. An artificial valve according to any embodiment described herein, in particular any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or less than the diameter of the primary suture.

[0394] Example 109. An artificial valve according to any embodiment described herein, in particular any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or less than the combined diameter of the primary and secondary sutures.

[0395] Example 110. An artificial valve according to any embodiment described herein, in particular any one of Examples 91 to 109, wherein at least one primary suture comprises two primary sutures, the two primary sutures being passed in opposite directions in an in-and-out pattern through the same penetration point.

[0396] Example 111. An artificial valve according to any embodiment described herein, in particular any one of Examples 105 to 107, wherein the diameter of the aperture is equal to or less than the diameter of the two primary sutures.

[0397] Example 112. An artificial valve according to any embodiment described herein, in particular Example 111, wherein the diameter of the aperture is equal to or less than the combined diameter of the two primary and secondary sutures.

[0398] Example 113. The primary suture is a multifilament suture, as described in any example herein, in particular, as described in any one of Examples 91 to 112.

[0399] Example 114. The secondary suture is an artificial valve according to any example described herein, in particular any one of Examples 91 to 113, comprising ultra-high molecular weight polyethylene.

[0400] Example 115. The skirt is an outer skirt disposed around the outer surface of the frame, as described in any embodiment herein, in particular, as described in any one of Examples 91 to 114.

[0401] Example 116. A method for assembling an artificial valve, The steps include passing the primary suture through the proximal edge of the skirt in an in-and-out pattern; The steps include: approximating the proximal end of the skirt, through which the primary suture has passed, to at least one strut section of the frame of the artificial valve; The process involves the steps of sewing a secondary suture through a primary suture and around at least one strut section, in a manner that forms multiple whip stitches wrapped around the strut section up to the final whip stitch; A step of forming a joint lock knot extending from the final whip stitch around the joint at each end of the corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of whip stitches wrapped around the strut section leading to the lateral side of the first joint, Methods that include...

[0402] Example 117. The method according to any embodiment herein, in particular Example 116, wherein the step of forming a joint lock knot includes extending a secondary suture from a final whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

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

[0406] Example 121. The method according to any embodiment described herein, in particular any one of Examples 117 to 120, wherein the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0407] Example 122. The method according to any embodiment described herein, in particular to any one of Examples 116 to 121, wherein the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

[0408] Example 123. The method according to any embodiment herein, in particular 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 each other by a joint, such that all whip stitches around one strut section are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

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

[0410] Example 125. The skirt is an outer skirt disposed around the outer surface of the frame, as described in any embodiment herein, in particular, as described in any one of Examples 116 to 124.

[0411] Example 126. An artificial valve, A frame that is movable between a radially compressed configuration and a radially expanded configuration, the frame comprising a plurality of strut sections that intersect at a joint, A valve leaflet assembly comprising a plurality of leaflets, which are mounted within a frame and configured to regulate the flow through an artificial valve, A skirt arranged around a frame, the skirt including a proximal end and a distal end, Includes, An artificial valve, wherein the proximal end of the skirt is connected to at least one strut section via at least one primary suture and a secondary suture, the at least one primary suture passing through the proximal end of the skirt in an in-and-out pattern, and the secondary sutures form a series of non-penetrating whipstitches spaced apart from each other along the length of the strut section, each non-penetrating whipstitch comprising 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, being looped around the primary suture, and passing between the primary suture and the valve leaflet.

[0412] Example 127. The proximal end of the skirt follows a zigzag pattern, as described in any embodiment herein, in particular, as described in Example 126.

[0413] Example 128. An artificial valve according to any embodiment described herein, in particular Example 127, wherein at least one primary suture tracks the zigzag pattern of the proximal end of the skirt.

[0414] Example 129. An artificial valve according to any embodiment herein, in particular any one of Examples 126 to 128, wherein the primary suture defines a series of running stitch portions, and each primary suture wrap section is looped around the corresponding running stitch portion and extends between the running stitch portion and the proximal end of the skirt.

[0415] Example 130. The artificial valve described in any example herein, in particular any one of Examples 126 to 129, wherein the secondary suture does not penetrate the skirt.

[0416] Example 131. An artificial valve according to any example described herein, in particular any one of Examples 126 to 130, wherein the secondary suture does not penetrate the primary suture.

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

[0418] Example 133. Each joint lock knot is: A transition section extending over one axial side of the joint, from the lateral side of the first joint to the lateral side of the second joint; A first loop, the first loop extending from the transition section and extending around a strut section extending from the lateral side of the second joint; A second loop, the second loop extending from the first loop between the transition section and the junction, and folding back over itself so as to extend through the first loop, Artificial valves as described in any embodiment herein, including, in particular, the artificial valve described in Example 132.

[0419] Example 134. The transition section extends obliquely 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, as described in any embodiment herein, in particular, as described in Example 133.

[0420] Example 135. An artificial valve according to any embodiment described herein, in particular, Example 133 or 134, wherein both the first loop and the second loop are tightly tensioned around the joint.

[0421] Example 136. An artificial valve according to any embodiment described herein, in particular, one of any one of Examples 132 to 135, wherein each of the multiple 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. The proximal end of the skirt is sutured to at least two strut sections extending from both lateral sides of a selected joint, via a plurality of non-penetrating whip stitches wrapped around each of the respective strut sections and a joint lock knot around the joint positioned between them, wherein the plurality of non-penetrating whip stitches around one of the strut sections are angled in the opposite direction to those of the plurality of non-penetrating whip stitches wrapped around the other strut section, as described in any embodiment herein, in particular, as described in Example 136.

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

[0424] Example 139. An artificial valve described in any embodiment herein, in particular, as described in Example 138, wherein an additional primary suture is arranged around the inlet end portion to track the shape of the strut section.

[0425] Example 140. The primary suture is a multifilament suture, as described in any example herein, in particular, as described in any one of Examples 126 to 139.

[0426] Example 141. The secondary suture is an artificial valve according to any example described herein, in particular any one of Examples 126 to 140, comprising ultra-high molecular weight polyethylene.

[0427] Example 142. The skirt is an outer skirt disposed around the outer surface of the frame, as described in any embodiment herein, in particular, as described in any one of Examples 126 to 141.

[0428] Example 143. A method for assembling an artificial valve, wherein the method is: The steps include passing the primary suture through the proximal edge of the skirt in an in-and-out pattern; The steps include: approximating the proximal end of the skirt, through which the primary suture has passed, to at least one strut section of the frame of the artificial valve; A step of looping a secondary suture around at least one strut section and around a primary suture, in a manner that forms multiple non-penetrating whipstitches wrapped around a strut section up to a final non-penetrating whipstitch, wherein each non-penetrating whipstitch includes a strut-wrapping section and a primary suture-wrapping section, the strut-wrapping section being looped around the strut section, and the primary suture-wrapping section extending from the strut-wrapping section and passing between the primary suture and the proximal end of the skirt around the primary suture, and Methods that include...

[0429] Example 144. The method according to any embodiment herein, in particular Example 143, wherein the step of forming each non-penetrating whip stitch includes forming a strut wrap section by extending a secondary suture across one radial side of the strut section, folding it over the axial side of the strut section, and extending it rearward across the opposite radial side of the strut section.

[0430] Example 145. The method according to any embodiment described herein, particularly Example 144, wherein the step of forming each non-penetrating 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 over the running stitch portion to form a primary suture wrap section.

[0431] Example 146. The method according to any embodiment described herein, particularly Example 144, wherein the step of forming each non-penetrating whip stitch further includes the step of passing the 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 to form a primary suture wrap section.

[0432] Example 147. The method according to any embodiment described herein, in particular, of 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 according to any embodiment described herein, in particular to any one of Examples 143 to 147, further comprising the step of forming a joint lock knot extending from a final non-penetrating whip stitch around a joint at each end of a corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of non-penetrating whip stitches wrapped around a strut section leading to a first lateral side of the joint.

[0434] Example 149. The method according to any embodiment herein, in particular Example 148, wherein the step of forming a joint lock knot includes extending a secondary suture from a final non-penetrating whip stitch located on a first transverse side of the joint, over one axial side of the joint, toward a second transverse side of the joint, thereby forming a transition section of the joint lock knot.

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

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

[0437] Example 152. The method according to any embodiment described herein, in particular Example 151, wherein the step of forming a joint lock knot further includes the step of forcibly pulling the tail of the second loop and tightening both the first loop and the second loop around the joint.

[0438] Example 153. The method according to any embodiment described herein, in particular any one of Examples 149 to 152, wherein the step of forming a transition section includes extending a secondary suture obliquely from one radial side of the joint to the opposite radial side of the joint, and from one transverse side of the joint to the opposite transverse side of the joint.

[0439] Example 154. The method according to any embodiment described herein, in particular any one of Examples 148 to 153, wherein the step of forming multiple whip stitches around any single strut section includes the step of forming multiple angled whip stitches oriented in the same direction around the length of the corresponding strut section.

[0440] Example 155. The method according to any embodiment herein, in particular 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 each other by a joint, such that all whip stitches around one strut section are formed as angled whip stitches oriented in one direction, and all whip stitches around the other strut section are formed as angled whip stitches oriented in a second direction opposite to the first direction.

[0441] Furthermore, it is understood that certain features of the present invention (which, for clarity, are described in the context of a separate embodiment) may also be provided in combination in a single embodiment. Conversely, various features of the present invention (which, for brevity, are described in the context of a single embodiment) may also be provided separately, in any suitable subcombination, or as appropriate in any other described embodiment of the present invention. Features described in the context of an embodiment shall not be considered essential features of that embodiment unless expressly specified otherwise.

[0442] In consideration 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 considered limiting. Rather, the scope is defined by the following claims. Accordingly, everything that falls within the scope and spirit of these claims is claimed to be the present invention. [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 part 105 Inflow end 105´´ Inflow end 106 frames 106' Frame 106'' Frame 108 cells 110 strut 110' Strut 110'' Angled strut 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 Interconnection window frame section 114 strut 116 Non-vertex joints 116' Non-vertex junction 116'' Non-vertex junction 116''a Non-vertex junction 116''b Non-vertex junction 116''c Non-vertex junction 116b Joint 116f joint 116m joint 116n joint 116o joint 116p joint 116q joint 116r joint 116s joint 116t joint 118 Inflow peak 118' Inflow peak 118'' Inflow peak 120 Outflow peak 120' Outflow peak 120'' Peak of the leak 122 Actuator Assembly 123 Skirt 124 Outer skirt 126 Outer surface of the skirt 125 Inner surface of skirt 128 Distal end of skirt 129 Skirt proximal end 130 valve 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 sutures 144a Primary suture 144b Primary suture 146 Inside stitching 148 Outer stitching 148a Outer stitching 148b Outer stitching section 148c Outer stitching 150 Penetration Points 150a Penetration Point 150b Penetration Point 150n Final penetration point 152 Inner surface of valve leaflets 154 Valve leaflet lateral surface 156 Secondary sutures 158 Self-tightening structure 160 loops 160a Loop 160b Loop 162 Generally horseshoe-shaped (or U-shaped) sections 164 Suture pulling area 166r knot 166s knot 166t knot 170 Secondary sutures 172 Whipped Stitch 172a Whipped Stitch 172b Whipped Stitch 172c Whipstitch 172n Final whip stitch 174 Joint lock knot 174m Joint lock knot 174n Joint lock knot 174o Joint lock knot 174p Joint locking knot 174q Joint locking knot 174r Joint lock knot 174s Joint lock knot 174t Joint lock knot 176 Transition Section 178 The First Loop 180 Second Loop 182 Non-penetrating whipstitch 182a Non-penetrating whipstitch 182a' Non-penetrating whipstitch 182a´´ Non-penetrating whipstitch 182b Non-penetrating whipstitch 182b' Non-penetrating whipstitch 182b´´ Non-penetrating whip stitch 182c Non-penetrating whipstitch 182d Non-penetrating whipstitch 182n Final non-penetrating whip stitch 184 Strut-wrapped section 184a Strut-wrapped section 184a' Strut-wrapped section 184a'' Strut-wrapped section 184b Strut-wrapped section 184c Strut-wrapped section 185 Strut Loop Section 185a Strut Loop Section 185b Strut Loop Section 186 Primary suture wrapped section 186a Section with primary suture wrapping 186a' Section with primary suture wrapping 186a'' Section with primary suture wrapping 186b Section with primary suture wrapping 186b' Section with primary suture wrapping 186b'' Section with primary suture wrapping 186c Section with primary suture wrapping 186n Final primary suture wrapped section 190 Proximal lateral part of strut 191 Distal lateral part of strut 192 Inner side of strut 193 Strut outer side 194 Proximal side of the joint 195 Distal side of the junction 196 Inner side of the joint 197 Outer side of joint 198 Lateral side of the first joint 199 Second joint lateral side

Claims

1. A method for assembling an artificial valve, The steps include: passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include bringing the cusp end portion, through which the primary suture has been passed, closer to at least one strut of the artificial valve frame; A step of sewing a secondary suture through the primary suture and around at least one of the struts in a manner that forms a plurality of self-tightening structures, wherein each self-tightening structure is formed to include at least one loop configured to contract around the strut under tension, Methods that include...

2. The method according to claim 1, wherein the step of sewing the secondary suture includes passing the secondary suture radially outward through the primary suture at the penetration point, thereby forming at least one loop around at least one of the struts.

3. The method according to claim 2, wherein the step of sewing the secondary suture includes, after forming the first loop, looping the secondary suture again around at least one of the struts, thereby forming two loops for each self-tightening structure.

4. The method according to claim 1, wherein the step of sewing the secondary suture includes passing the secondary suture under at least one loop between at least one loop and at least one strut, thereby forming a U-shaped section.

5. A method for assembling an artificial valve, The steps include: passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include bringing the cusp end portion, through which the primary suture has been passed, closer to at least one strut section of the frame of the artificial valve; The steps include sewing a secondary suture through the primary suture and around at least one strut section in a manner that forms a plurality of whip stitches wrapped around the strut section up to the final whip stitch; A step of forming a joint lock knot extending from the final whip stitch around the joint at each end of the corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of whip stitches wrapped around the strut section connected to the lateral side of the first joint, Methods that include...

6. The method according to claim 5, wherein the step of forming the joint lock knot includes extending the secondary suture from the final whip stitch located on the first lateral side of the joint, over one axial side of the joint, toward the second lateral side of the joint, thereby forming a transition section of the joint lock knot.

7. The method according to claim 6, wherein the step of forming the joint lock knot further includes extending the 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 lock knot.

8. The method according to claim 7, wherein the step of forming the joint lock knot further includes extending the secondary suture from the first loop between the transition section and the joint, folding the secondary suture back over itself, passing it through the first loop, thereby forming a second loop of the joint lock knot.

9. The method according to claim 8, wherein the step of forming the joint lock 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.

10. The method according to claim 6, wherein the step of forming the transition section includes extending the secondary suture obliquely 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.

11. The method according to claim 5, wherein the step of forming a plurality of the whipstitches around any single strut section includes the step of forming a plurality of angled whipstitches oriented in the same direction around the length of the corresponding strut section.

12. The method according to claim 11, wherein the step of sewing the secondary suture around at least one strut section includes the step of sewing around at least two strut sections separated from each other by an interjoint, so that all whip stitches around one of the at least two strut sections are formed as angled whip stitches oriented in a first direction, and on the other side, all whip stitches around the other of the at least two strut sections are formed as angled whip stitches oriented in a second direction opposite to the first direction.

13. The method according to claim 5, wherein the cusp end portion of each valve leaflet includes a series of pre-formed apertures, and the step of passing a primary suture includes passing the primary suture through the series of pre-formed apertures in an in-and-out pattern.

14. A method for assembling an artificial valve, The steps include: passing the primary suture through the cusp end portion of the valve leaflet in an in-and-out pattern; The steps include bringing the cusp end portion, through which the primary suture has been passed, closer to at least one strut section of the frame of the artificial valve; A step of looping a secondary suture around at least one of the strut sections and around the primary suture, in a manner that forms a plurality of non-penetrating whipstitches wrapped around the strut section up to a final non-penetrating whipstitch, wherein each non-penetrating whipstitch includes a strut-wrapping section and a primary suture-wrapping section, the strut-wrapping section being looped around the strut section, and the primary suture-wrapping section extending from the strut-wrapping section, passing between the primary suture and the valve leaflet, and being looped around the primary suture; Methods that include...

15. The steps for forming each non-penetrating whip stitch are: The secondary suture is extended across one radial side of the strut section, Fold it over the axial side of the strut section, Extending it rearward across the radial side of the strut section opposite to the strut section, The method according to claim 14, comprising the step of forming the strut-wrapped section by means of the method.

16. The steps for forming each non-penetrating whip stitch are: The secondary suture is passed between the running stitch portion of the primary suture and the cusp end portion of the valve leaflet. Fold it over the aforementioned running stitch section. The method according to claim 15, further comprising the step of forming the primary suture-wrapped section by means of the method.

17. The steps for forming each non-penetrating whip stitch are: The secondary suture is passed over the running stitch portion of the primary suture. On the running stitch portion, and between the running stitch portion and the cusp end portion of the valve leaflet, loop it back. The method according to claim 15, further comprising the step of forming the primary suture-wrapped section by means of the method.

18. The method according to claim 16, wherein the running stitch portion is the outer stitch portion of the primary suture.

19. The method according to claim 14, further comprising the step of forming a joint lock knot extending from the final non-penetrating whip stitch around the joint at each end of the corresponding strut section, wherein the joint lock knot is configured to maintain tension on a plurality of the non-penetrating whip stitches wrapped around the strut section leading to the first lateral side of the joint.

20. The method according to claim 19, wherein the step of forming the joint lock knot includes extending the secondary suture from the final non-penetrating whip stitch located on the first lateral side of the joint, over one axial side of the joint, toward the second lateral side of the joint, thereby forming a transition section of the joint lock knot.

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