The leaflet and skirt attachment structures to the framework of the prosthetic valve

Abstract

This application discloses a leaflet and skirt attachment structure to a frame of a prosthetic valve. The present invention relates to implantable prosthetic devices (such as prosthetic heart valves), and to attachment structures and methods for attaching soft components (such as leaflets or skirts) to the frame of such prosthetic valves.

Description

Technical Field

[0001] The present invention relates to implantable prosthetic devices (such as prosthetic heart valves), and to attachment structures and methods for attaching soft parts (such as leaflets or skirts) to the frame of such prosthetic valves. Background Technology

[0002] Native heart valves (such as the aortic, pulmonary, and mitral valves) ensure proper flow of blood from the heart and between the heart's chambers to supply blood to the entire cardiovascular system. Various valvular diseases can lead to valve inefficiency and require replacement with prosthetic valves. Surgical procedures can be performed to repair or replace heart valves. Due to the high risk of clinical complications associated with surgery, minimally invasive alternative techniques have been developed in recent years, including catheter-based delivery of prosthetic heart valves and implantation on top of the native, dysfunctional valves.

[0003] To date, different types of prosthetic heart valves are known, including balloon-expandable valves, self-expandable valves, and mechanically expandable valves. Different delivery and implantation methods are also known and can vary depending on the implantation site and the type of prosthetic valve. One exemplary technique involves the use of a delivery component for delivering a prosthetic valve in a coiled configuration from an incision that may be located at the patient's femoral or iliac artery toward the native dysfunctional valve. Once the prosthetic valve is properly positioned at the desired implantation site, it can be expanded against surrounding anatomical structures, such as the annulus of the native valve, and the delivery component can then be retrieved.

[0004] One possible complication associated with implanted prosthetic heart valves is thrombosis on the prosthetic structure, which can lead to reduced leaflet motility or impaired apposition, decreased effective valve orifice area, increased transvalvular pressure gradient, or transvalvular regurgitation. Thrombi can form due to inward tissue growth in the fabric components of the prosthetic valve, such as the fabric used as an intermediate element for coupling the leaflets of the prosthetic valve to its frame. Therefore, there is a need for leaflet-to-frame coupling methods and constructions that minimize or eliminate the need for fabric components, thereby reducing the risk of inward tissue growth and thrombosis. Summary of the Invention

[0005] This disclosure relates to a prosthetic heart valve comprising an expandable frame and leaflet assembly, wherein the leaflet is coupled to a strut of the frame via a primary suture that passes through the leaflet tip portion in an in-out pattern, and a secondary suture passes through the primary suture and surrounds the strut, having a plurality of self-tightening structures configured to contract on the strut under tension.

[0006] According to one aspect of the invention, a prosthetic valve is provided, the prosthetic valve comprising a frame and a leaflet assembly, the frame being movable between a radially compressible configuration and a radially expanding configuration, the leaflet assembly being mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve. The frame includes a plurality of intersecting struts. Each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of opposing-pointing lugs separating the tip edge and the free edge.

[0007] Each tip portion is coupled to at least one support via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern at the penetration point, the secondary suture passing through the primary suture and surrounding at least one segment of the at least one support, wherein the secondary suture includes a plurality of self-tightening structures, and wherein each self-tightening structure includes at least one loop configured to contract around the support under tension.

[0008] According to some embodiments, the leaflet includes an inner surface and an outer surface, and the primary suture includes a plurality of inner suture portions disposed along the inner surface of the leaflet and a plurality of outer suture portions disposed along the outer surface of the leaflet, each inner suture portion and each outer suture portion being defined between a corresponding penetration point.

[0009] According to some embodiments, the self-tightening structure is defined between two penetration points, which define at least one outer trace portion therebetween.

[0010] According to some embodiments, the at least one ring of each self-tightening structure comprises two rings.

[0011] According to some embodiments, each self-tightening structure further includes a U-shaped section that extends partially between the at least one ring and the strut.

[0012] According to some embodiments, the secondary suture further includes a plurality of suture pull portions extending above the inner surface of the leaflet.

[0013] According to some embodiments, at least one of the suture pulling portions spans more than one inner or outer stitch portion.

[0014] According to some embodiments, the suture pulling portion presses against a portion of the at least one primary suture.

[0015] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0016] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0017] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0018] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0019] According to some embodiments, the tip portion of each leaflet includes a series of pre-formed holes.

[0020] According to some embodiments, the hole is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0021] According to some embodiments, the holes are spaced equally apart from each other.

[0022] According to some embodiments, the diameter of the hole is equal to or smaller than the diameter of the primary suture.

[0023] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0024] According to some embodiments, the secondary suture passes through all consecutive penetration points.

[0025] According to some embodiments, the at least one primary suture includes two primary sutures that pass through the same penetration point in opposite directions of the in-and-out pattern.

[0026] According to some embodiments, the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0027] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the two primary sutures and the secondary suture.

[0028] According to some embodiments, the at least one primary suture tracks the curvature of the at least one tip edge.

[0029] According to some embodiments, the primary suture includes a multifilament suture.

[0030] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0031] According to some embodiments, the prosthetic valve has no fabric strips and / or cloth between the tip portion of the leaflets and the struts to which they are attached.

[0032] According to another aspect of the invention, a method of assembling a prosthetic valve is provided, the method comprising passing a primary suture through a tip portion of a leaflet in an in-out pattern. The method further comprises bringing the tip portion of the primary suture passing through it close to at least one strut of a frame of the prosthetic valve. The method further comprises suturing secondary sutures through the primary suture and around the at least one strut in a manner forming 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.

[0033] According to some embodiments, the secondary suture includes passing the secondary suture radially outward through the primary suture at the penetration point, thereby forming the at least one loop around the at least one pillar.

[0034] According to some embodiments, the secondary suture includes looping the secondary suture around the at least one post again after forming the first loop, thereby forming two loops for each self-tightening structure.

[0035] According to some embodiments, the secondary suture includes passing the secondary suture below the at least one loop and between the at least one loop and the at least one strut to form a U-shaped segment.

[0036] According to some embodiments, the method includes an additional step of extending the secondary suture over the inner surface of the leaflet and then passing the secondary suture through the primary suture again in a radially outward direction, thereby forming at least one suture pull portion extending over the inner surface of the leaflet.

[0037] According to some embodiments, the tip portion of each leaflet includes a series of pre-formed holes, and the step of passing the primary suture includes passing the primary suture through the series of pre-formed holes in an in-and-out pattern.

[0038] According to another aspect of the invention, a prosthetic valve is provided, the prosthetic valve comprising a frame and a leaflet assembly, the frame being movable between a radially compressible configuration and a radially expanding configuration, the leaflet assembly being mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve. The frame includes a plurality of strut segments intersecting at joints. Each joint is defined between: two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing lateral sides comprising a first lateral joint side and a second lateral joint side.

[0039] Each leaflet includes a rounded tip portion defining a pointed edge, a free edge opposite the pointed edge, and a pair of opposing-pointing lugs separating the pointed edge and the free edge. Each tip portion is coupled to at least one support segment via at least one primary suture and a secondary suture, the primary suture passing through it in an in-and-out pattern at a penetration point, and the secondary suture passing through the primary suture and wrapping around the support segment along its length with a series of spaced-apart suture stitches.

[0040] The tip portion is further coupled to at least one joint at the end of the support section via a joint lock knot formed by the secondary suture, wherein the joint lock knot is configured to maintain tension on the plurality of suture stitches wrapped around the corresponding support section leading to the first transverse section of the joint.

[0041] According to some embodiments, each joint lock includes: (1) a transition section, (2) a first ring and (3) a second ring, the transition section extending over one axial side of the joint in a direction from a first lateral side of the joint to a second lateral side of the joint, the first ring extending from the transition section and around a support section extending from the second lateral side of the joint, the second ring extending from the first ring between the transition section and the joint, and folded over itself to extend through the first ring.

[0042] According to some embodiments, the transition section extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0043] According to some embodiments, both the first ring and the second ring are tightly tensioned around the joint.

[0044] According to some embodiments, the respective plurality of seam stitches wrapped around a single support segment are inclined seam stitches oriented in the same direction along the length of the corresponding support segment.

[0045] According to some embodiments, the tip portion is stitched to at least two pillar sections extending from two lateral sides of a selected joint via a plurality of stitches wrapped around each of the respective pillar sections and a joint lock located therebetween around the joint, wherein the plurality of stitches around one of the pillar sections are inclined in a direction opposite to the direction of the plurality of stitches wrapped around the other pillar section.

[0046] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0047] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0048] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0049] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0050] According to some embodiments, the tip portion of each leaflet includes a series of pre-formed holes.

[0051] According to some embodiments, the hole is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0052] According to some embodiments, the holes are spaced equally apart from each other.

[0053] According to some embodiments, the diameter of the hole is equal to or smaller than the diameter of the primary suture.

[0054] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0055] According to some embodiments, the at least one primary suture includes two primary sutures that pass through the same penetration point in opposite directions of the in-and-out pattern.

[0056] According to some embodiments, the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0057] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the two primary sutures and the secondary suture.

[0058] According to some embodiments, the at least one primary suture tracks the curvature of the at least one tip edge.

[0059] According to some embodiments, the primary suture includes a multifilament suture.

[0060] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0061] According to some embodiments, the prosthetic valve has no fabric strips and / or cloth between the apical portion of the leaflet, the strut segment, and the junction to which they are attached.

[0062] According to another aspect of the invention, a method of assembling a prosthetic valve is provided, the method comprising passing a primary suture through a tip portion of a leaflet in an in-and-out pattern. The method further comprises bringing the tip portion having the primary suture passing through it close to at least one strut segment of a frame of the prosthetic valve. The method further comprises suturing secondary sutures through the primary suture and around the at least one strut segment in a manner forming a plurality of suture stitches wrapped around the strut segment until a final suture stitch.

[0063] The method further includes forming a joint lock knot extending from the final seam stitch around the corresponding end of the corresponding support section, wherein the joint lock knot is configured to maintain tension on the plurality of seam stitches wrapped around the support section and leading to the first transverse section of the joint.

[0064] According to some embodiments, the step of forming the joint lock includes extending the secondary suture from the final suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0065] According to some embodiments, the step of forming the joint lock further includes extending the secondary suture from the transition section around a support section extending from the second lateral side of the joint, thereby forming a first loop of the joint lock.

[0066] According to some embodiments, the step of forming the joint lock further includes extending the 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 to form a second loop of the joint lock.

[0067] According to some embodiments, the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0068] According to some embodiments, forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0069] According to some embodiments, forming the plurality of seam stitches around any single support segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding support segment.

[0070] According to some embodiments, suturing the secondary suture around the at least one support segment includes suturing around at least two support segments separated from each other by a common joint, such that all sutures around one of the support segments are formed as inclined sutures oriented in one direction, while all sutures around the other support segment are formed as inclined sutures oriented in a second direction opposite to the first direction.

[0071] According to some embodiments, the tip portion of each leaflet includes a series of pre-formed holes, and the step of passing the primary suture includes passing the primary suture through the series of pre-formed holes in an in-and-out pattern.

[0072] According to another aspect of the invention, a prosthetic valve is provided, the prosthetic valve comprising a frame and a leaflet assembly, the frame being movable between a radially compressible configuration and a radially expanding configuration, the leaflet assembly being mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve. The frame includes a plurality of strut segments intersecting at a junction. Each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of opposing-pointing lugs separating the tip edge and the free edge.

[0073] Each tip portion is coupled to at least one support segment via at least one primary suture and a secondary suture, the primary suture passing through it in an in-and-out pattern, the secondary sutures forming a series of non-penetrating suture stitches spaced apart from each other along the length of the support segment. Each non-penetrating suture stitch includes a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the leaflet.

[0074] According to some embodiments, the primary suture defines a series of straight stitch portions, wherein each primary suture wrapping segment loops around a corresponding straight stitch portion and extends between the straight stitch portion and the rounded tip portion.

[0075] According to some embodiments, the secondary suture does not penetrate through the leaflet.

[0076] According to some embodiments, the secondary suture does not penetrate through the primary suture.

[0077] According to some embodiments, the tip portion is further coupled to at least one joint at the end of the support segment via a joint lock knot formed by the secondary sutures. Each joint is defined between: two opposing axial sides, the two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing lateral sides, the two opposing lateral sides comprising a first lateral joint side and a second lateral joint side. Each joint lock knot is configured to maintain tension on the plurality of non-penetrating sutures wound around the corresponding support segment leading to the first lateral joint segment.

[0078] According to some embodiments, each joint lock includes: (1) a transition section, (2) a first ring and (3) a second ring, the transition section extending over one axial side of the joint in a direction from a first lateral side of the joint to a second lateral side of the joint, the first ring extending from the transition section and around a support section extending from the second lateral side of the joint, the second ring extending from the first ring between the transition section and the joint, and folded over itself to extend through the first ring.

[0079] According to some embodiments, the transition section extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0080] According to some embodiments, the transition section extends in a diagonal direction from one radial side of the joint toward 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, both the first ring and the second ring are tightly tensioned around the joint.

[0082] According to some embodiments, the plurality of non-penetrating stitches wound around a single support segment are inclined non-penetrating stitches oriented in the same direction along the length of the corresponding support segment.

[0083] According to some embodiments, the tip portion is stitched to at least two pillar segments extending from two lateral sides of a selected joint via a plurality of non-penetrating stitches wrapped around each of the respective pillar segments and a joint lock knot positioned therebetween around the joint, wherein the plurality of non-penetrating stitches around one of the pillar segments are inclined in a direction opposite to the direction of the plurality of non-penetrating stitches wrapped around the other pillar segment.

[0084] According to some embodiments, the at least one primary suture includes two primary sutures that pass in opposite directions to the in-and-out pattern.

[0085] According to some embodiments, the at least one primary suture tracks the curvature of the at least one tip edge.

[0086] According to some embodiments, the primary suture includes a multifilament suture.

[0087] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0088] According to some embodiments, the prosthetic valve has no fabric strips and / or cloth between the tip portion of the leaflets and the strut segment to which they are attached.

[0089] According to another aspect of the invention, a method of assembling a prosthetic valve is provided, the method comprising passing a primary suture through a tip portion of a leaflet in an in-and-out pattern. The method further comprises bringing the tip portion of the primary suture passing through it close to at least one strut segment of a frame of the prosthetic valve. The method further comprises looping the secondary suture around the at least one strut segment and around the primary suture in such a manner that it forms a plurality of non-penetrating suture stitches around the strut segment up to a final non-penetrating suture stitch. Each non-penetrating suture stitch includes a strut-wrapping segment looping around the strut segment and a primary suture-wrapping segment extending therefrom, the primary suture-wrapping segment passing between the primary suture and the leaflet and looping around the primary suture.

[0090] According to some embodiments, forming each non-penetrating suture includes forming the support wrapping section by extending the secondary suture across one radial side of the support section, folding it over the axial side of the support, and extending it rearward across the opposite radial side of the support.

[0091] According to some embodiments, forming each non-penetrating suture stitch further includes forming the primary suture wrapping section by passing the secondary suture between the straight stitch portion of the primary suture and the tip portion of the leaflet, and folding it over the straight stitch portion.

[0092] According to some embodiments, forming each non-penetrating suture stitch further includes forming the primary suture wrapping section by passing the secondary suture over the straight stitch portion of the primary suture, and returning it over the straight stitch portion and looping it between the straight stitch portion and the tip portion of the leaflet.

[0093] According to some embodiments, the straight stitch portion is the outer stitch portion of the primary suture.

[0094] According to some embodiments, the method further includes the step of forming a joint lock knot extending from the final non-penetrating stitch around the corresponding end of the corresponding support section, wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating stitches wrapped around the support section and leading to the first transverse section of the joint.

[0095] According to some embodiments, the step of forming the joint lock includes extending the secondary suture from the final non-penetrating suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0096] According to some embodiments, the step of forming the joint lock further includes extending the secondary suture from the transition section around a support section extending from the second lateral side of the joint, thereby forming a first loop of the joint lock.

[0097] According to some embodiments, the step of forming the joint lock further includes extending the 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 to form a second loop of the joint lock.

[0098] According to some embodiments, the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0099] According to some embodiments, forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0100] According to some embodiments, forming the plurality of seam stitches around any single support segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding support segment.

[0101] According to some embodiments, forming the plurality of seam stitches around the at least one support segment includes forming a plurality of seam stitches around at least two support segments separated from each other by a common joint, such that all seam stitches around one of the support segments are formed as inclined seam stitches oriented in one direction, while all seam stitches around the other support segment are formed as inclined seam stitches oriented in a second direction opposite to the first direction.

[0102] According to another aspect of the invention, a prosthetic valve is provided, the prosthetic 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 compressible configuration and a radially expanding configuration, and includes a plurality of strut segments intersecting at a junction. The leaflet assembly includes a plurality of leaflets configured to regulate flow through the prosthetic valve. The skirt includes a proximal skirt end and a distal skirt end.

[0103] Each joint is defined between: two opposing axial sides, the two opposing axial sides including a proximal side of the joint and a distal side of the joint; two opposing radial sides, the two opposing radial sides including an inner side of the joint and an outer side of the joint; and two opposing lateral sides, the two opposing lateral sides including a first lateral side of the joint and a second lateral side of the joint.

[0104] The proximal end of the skirt is coupled to at least one support section via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern at the penetration point, the secondary suture passing through the primary suture and wrapping around the support section with a series of interlocking stitches spaced apart from each other along the length of the support section.

[0105] The proximal end of the skirt is further coupled to at least one joint at the end of the support section via a joint lock formed by the secondary stitches, wherein the joint lock is configured to maintain tension on the plurality of seam stitches wrapped around the corresponding support section and leading to the first transverse section of the joint.

[0106] According to some embodiments, the near end of the skirt follows a zigzag pattern.

[0107] According to some embodiments, the at least one primary stitch follows a zigzag pattern near the proximal end of the skirt.

[0108] According to some embodiments, each joint lock includes: (1) a transition section, (2) a first ring and (3) a second ring, the transition section extending over one axial side of the joint in a direction from a first lateral side of the joint to a second lateral side of the joint, the first ring extending from the transition section and around a support section extending from the second lateral side of the joint, the second ring extending from the first ring between the transition section and the joint, and folded over itself to extend through the first ring.

[0109] According to some embodiments, the transition section extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0110] According to some embodiments, both the first ring and the second ring are tightly tensioned around the joint.

[0111] According to some embodiments, the respective plurality of seam stitches wrapped around a single support segment are inclined seam stitches oriented in the same direction along the length of the corresponding support segment.

[0112] According to some embodiments, the proximal end of the skirt is stitched to at least two pillar sections extending from two lateral sides of the selected joint via a plurality of seam stitches wrapped around each of the respective pillar sections and a joint lock knot positioned therebetween around the joint, wherein the plurality of seam stitches around one of the pillar sections are inclined in a direction opposite to the direction of the plurality of seam stitches wrapped around the other pillar section.

[0113] According to some embodiments, the distal end of the skirt is coupled at the inflow portion of the valve to at least one support segment via at least one additional primary suture and at least one additional secondary suture, the at least one additional primary suture passing through it in an in-out pattern at the penetration point, the additional secondary suture passing through the primary suture and wrapping around the support segment at the inflow portion with a series of interlocking stitches spaced apart from each other along the length of the support segment, wherein the distal end of the skirt is coupled via an additional joint lock to at least one joint at the end of the support segment at the inflow portion.

[0114] According to some embodiments, the additional primary suture tracks the shape of the support section disposed around the inflow end portion.

[0115] According to some embodiments, the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0116] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0117] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0118] According to some embodiments, the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0119] According to some embodiments, the proximal end of the skirt includes a series of pre-formed holes.

[0120] According to some embodiments, the hole is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0121] According to some embodiments, the holes are spaced equally apart from each other.

[0122] According to some embodiments, the diameter of the hole is equal to or smaller than the diameter of the primary suture.

[0123] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0124] According to some embodiments, the at least one primary suture includes two primary sutures that pass through the same penetration point in opposite directions of the in-and-out pattern.

[0125] According to some embodiments, the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0126] According to some embodiments, the diameter of the hole is equal to or less than the combined diameter of the two primary sutures and the secondary suture.

[0127] According to some embodiments, the primary suture includes a multifilament suture.

[0128] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0129] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0130] According to another aspect of the invention, a method of assembling a prosthetic valve is provided, the method comprising passing a primary suture through a skirt proximal end of a skirt in an in-out pattern. The method further comprises bringing the skirt proximal end, having the primary suture passing through it, close to at least one strut segment of a frame of the prosthetic valve. The method further comprises suturing secondary sutures through the primary sutures and around the at least one strut segment in a manner forming a plurality of suture stitches wrapped around the strut segment up to a final suture stitch. The method further comprises forming a joint lock knot extending from the final suture stitch around a corresponding end of the corresponding strut segment, wherein the joint lock knot is configured to maintain tension on the plurality of suture stitches wrapped around the strut segment leading to a first transverse segment of the joint.

[0131] According to some embodiments, the step of forming the joint lock includes extending the secondary suture from the final suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0132] According to some embodiments, the step of forming the joint lock further includes extending the secondary suture from the transition section around a support section extending from the second lateral side of the joint, thereby forming a first loop of the joint lock.

[0133] According to some embodiments, the step of forming the joint lock further includes extending the 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 to form a second loop of the joint lock.

[0134] According to some embodiments, the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0135] According to some embodiments, forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0136] According to some embodiments, forming the plurality of seam stitches around any single support segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding support segment.

[0137] According to some embodiments, suturing the secondary suture around the at least one support segment includes suturing around at least two support segments separated from each other by a common joint, such that all sutures around one of the support segments are formed as inclined sutures oriented in one direction, while all sutures around the other support segment are formed as inclined sutures oriented in a second direction opposite to the first direction.

[0138] According to some embodiments, the proximal end of the skirt includes a series of pre-formed holes, and the step of passing the primary stitch includes passing the primary stitch through the series of pre-formed holes in an in-and-out pattern.

[0139] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0140] According to another aspect of the invention, a prosthetic valve is provided, the prosthetic 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 compressible configuration and a radially expanding configuration, and includes a plurality of strut segments intersecting at a junction. The leaflet assembly includes a plurality of leaflets configured to regulate flow through the prosthetic valve. The skirt includes a proximal skirt end and a distal skirt end.

[0141] The proximal end of the skirt is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern, the secondary suture forming a series of non-penetrating sutures spaced apart from each other along the length of the support segment, each non-penetrating suture including a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the leaflet.

[0142] According to some embodiments, the near end of the skirt follows a zigzag pattern.

[0143] According to some embodiments, the at least one primary stitch follows a zigzag pattern near the proximal end of the skirt.

[0144] According to some embodiments, the primary suture defines a series of straight stitch portions, wherein each primary suture wrapping segment loops around the corresponding straight stitch portion and extends between the straight stitch portion and the proximal end of the skirt.

[0145] According to some embodiments, the secondary stitching does not penetrate through the skirt.

[0146] According to some embodiments, the secondary suture does not penetrate through the primary suture.

[0147] According to some embodiments, each joint is defined between: two opposing axial sides, the two opposing axial sides including a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides including an inner joint side and an outer joint side; and two opposing lateral sides, the two opposing lateral sides including a first lateral joint side and a second lateral joint side. The proximal end of the skirt is further coupled to at least one joint at the end of the support section via a joint lock knot formed by the secondary sutures, and wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating stitches wrapped around the corresponding support section leading to the first lateral joint section.

[0148] According to some embodiments, each joint lock includes: (1) a transition section, (2) a first ring and (3) a second ring, the transition section extending over one axial side of the joint in a direction from a first lateral side of the joint to a second lateral side of the joint, the first ring extending from the transition section and around a support section extending from the second lateral side of the joint, the second ring extending from the first ring between the transition section and the joint, and folded over itself to extend through the first ring.

[0149] According to some embodiments, the transition section extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0150] According to some embodiments, both the first ring and the second ring are tightly tensioned around the joint.

[0151] According to some embodiments, the respective plurality of seam stitches wrapped around a single support segment are inclined seam stitches oriented in the same direction along the length of the corresponding support segment.

[0152] According to some embodiments, the proximal end of the skirt is stitched to at least two pillar sections extending from two lateral sides of a selected joint via a plurality of non-penetrating stitches wrapped around each of the respective pillar sections and a joint lock knot positioned therebetween around the joint, wherein the plurality of non-penetrating stitches around one of the pillar sections are inclined in a direction opposite to the direction of the plurality of non-penetrating stitches wrapped around the other pillar section.

[0153] According to some embodiments, the distal end of the skirt is coupled at the inflow portion of the valve to at least one support segment via at least one additional primary suture and at least one additional secondary suture, the at least one additional primary suture passing through it in an in-out pattern at the penetration point, the additional secondary suture passing through the primary suture and wrapping around the support segment at the inflow portion with a series of interlocking stitches spaced apart from each other along the length of the support segment, wherein the distal end of the skirt is coupled via an additional joint lock to at least one joint at the end of the support segment at the inflow portion.

[0154] According to some embodiments, the additional primary suture tracks the shape of the support section disposed around the inflow end portion.

[0155] According to some embodiments, the primary suture includes a multifilament suture.

[0156] According to some embodiments, the secondary suture comprises ultra-high molecular weight polyethylene.

[0157] According to some embodiments, the skirt is an outer skirt disposed around the outer surface of the frame.

[0158] According to another aspect of the invention, a method of assembling a prosthetic valve is provided, the method comprising passing a primary suture through a skirt proximal end of a skirt in an in-out pattern. The method further comprises bringing the skirt proximal end having the primary suture passing therethrough close to at least one strut segment of a frame of the prosthetic valve. The method further comprises looping the secondary suture around the at least one strut segment and around the primary suture in such a manner that it forms a plurality of non-penetrating suture stitches around the strut segment up to a final non-penetrating suture stitch, each non-penetrating suture stitch comprising a strut wrapping segment looping around the strut segment and a primary suture wrapping segment extending therefrom, the primary suture wrapping segment passing around the primary suture between the primary suture and the skirt proximal end.

[0159] According to some embodiments, forming each non-penetrating suture includes forming the support wrapping section by extending the secondary suture across one radial side of the support section, folding it over the axial side of the support section, and extending it rearward across the opposite radial side of the support section.

[0160] According to some embodiments, forming each non-penetrating suture stitch further includes forming the primary suture wrapping section by passing the secondary suture between the straight stitch portion of the primary suture and the proximal end of the skirt, and folding it over the straight stitch portion.

[0161] According to some embodiments, forming each non-penetrating suture stitch further includes forming the primary suture wrapping section by: passing the secondary suture over the straight stitch portion of the primary suture, and returning over the straight stitch portion and forming a loop between the straight stitch portion and the proximal end of the skirt.

[0162] According to some embodiments, the skirt portion is an outer skirt portion, and the straight stitch portion is the inner stitch portion of the primary seam.

[0163] According to some embodiments, the method further includes the step of forming a joint lock knot extending from the final non-penetrating stitch around the corresponding end of the corresponding support section, wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating stitches wrapped around the support section and leading to the first transverse section of the joint.

[0164] According to some embodiments, the step of forming the joint lock includes extending the secondary suture from the final non-penetrating suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0165] According to some embodiments, the step of forming the joint lock further includes extending the secondary suture from the transition section around a support section extending from the second lateral side of the joint, thereby forming a first loop of the joint lock.

[0166] According to some embodiments, the step of forming the joint lock further includes extending the 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 to form a second loop of the joint lock.

[0167] According to some embodiments, the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0168] According to some embodiments, forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0169] According to some embodiments, forming the plurality of seam stitches around any single support segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding support segment.

[0170] According to some embodiments, forming the plurality of seam stitches around the at least one support segment includes forming a plurality of seam stitches around at least two support segments separated from each other by a common joint, such that all seam stitches around one of the support segments are formed as inclined seam stitches oriented in one direction, while all seam stitches around the other support segment are formed as inclined seam stitches oriented in a second direction opposite to the first direction.

[0171] Some embodiments of the present invention may include some, all, or none of the advantages described above. Further advantages will be apparent to those skilled in the art from the accompanying drawings, description, and claims included herein. Aspects and embodiments of the invention are further described in the following specification and appended claims.

[0172] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In the event of any conflict, this patent specification (including the definitions) shall prevail. As used herein, unless the context clearly indicates otherwise, the indefinite articles “a” and “an” mean “at least one” or “one or more”.

[0173] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods intended to be exemplary and illustrative, but not limiting in scope. In various embodiments, one or more of the problems described above have been reduced or eliminated, while other embodiments address other advantages or improvements. Attached Figure Description

[0174] Some embodiments of the invention have been described herein with reference to the accompanying drawings. The description, taken in conjunction with the drawings, makes it apparent to those skilled in the art how some embodiments can be practiced. The drawings are for illustrative purposes and are not intended to show structural details of the embodiments in more detail than are necessary for a basic understanding of the invention. For clarity, some objects depicted in the drawings are not to scale.

[0175] In the attached diagram:

[0176] Figure 1A A perspective view of a mechanically expandable prosthetic valve according to some embodiments is shown.

[0177] Figure 1BA perspective view of a balloon-expandable prosthetic valve according to some embodiments is shown.

[0178] Figure 2 A single leaflet is shown according to some embodiments.

[0179] Figure 3 A leaflet assembly defined by three leaflets prior to assembly is shown according to some embodiments.

[0180] Figure 4 An enlarged cross-sectional view of the tip portion of the leaflet, according to some embodiments, is shown, in which the primary suture passes through to enter and exit the pattern.

[0181] Figures 5A-5E Various stages of an exemplary technique, according to some embodiments, for coupling leaflets along their tip end portion to a support of a frame are shown.

[0182] Figure 6 An exemplary construction is shown of a leaflet coupled to a strut via primary and secondary sutures according to some embodiments.

[0183] Figure 7 An enlarged cross-sectional view of the tip portion of the leaflet, according to some embodiments, is shown, in which two primary sutures pass through to enter and exit the pattern.

[0184] Figure 8 Another exemplary construction of a leaflet coupled to a strut via primary and secondary sutures, according to some embodiments, is shown.

[0185] Figures 9A-9D Various stages of exemplary techniques for coupling leaflets along their tip portions to support sections and joints of a frame, according to some embodiments, are shown.

[0186] Figure 10 A partial view of a prosthetic valve having leaflets coupled to multiple strut segments and junctions, according to some embodiments, is shown.

[0187] Figures 11A-11D Various stages of another exemplary technique, according to some embodiments, for coupling leaflets along their tip end portions to the support sections and joints of a frame are shown.

[0188] Figures 12A-12D Various stages of another exemplary technique, according to some embodiments, for coupling leaflets along their tip end portions to the support sections and joints of a frame are shown.

[0189] Figure 13 Another exemplary suture structure is shown.

[0190] Figure 14 Another exemplary suture structure is shown.

[0191] Figure 15 A perspective view of a prosthetic valve with an outer skirt, according to some embodiments, is shown.

[0192] Figure 16 A skirt having multiple support sections and joints coupled together is shown according to some embodiments. Figure 15 A partial view of the prosthetic valve.

[0193] Figure 17 A perspective view of another exemplary prosthetic valve with an outer skirt, according to some embodiments, is shown.

[0194] Figure 18 A skirt having multiple support sections and joints coupled together is shown according to some embodiments. Figure 17 A partial view of the prosthetic valve. Detailed Implementation

[0195] In the following description, various aspects of this disclosure will be described. Specific configurations and details are set forth for purposes of explanation in order to provide a thorough understanding of the different aspects of this disclosure. However, it will be equally apparent to those skilled in the art that this disclosure can be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure this disclosure. To avoid excessive clutter due to numerous reference numerals and leads in the specific drawings, some components will be introduced via one or more drawings and will not be explicitly identified in every subsequent drawing that includes that component.

[0196] Figure 1A and Figure 1B Perspective views of two exemplary types of prosthetic valves 100 according to some embodiments are shown. It should be understood that throughout... Figures 1A-1B Different embodiments of the same element are indicated by reference numerals with an apostrophe (') or double apostrophes ("). Embodiments of the disclosed apparatus and systems may include any combination of different embodiments of the same element. Specifically, any reference to an element without a single or double apostrophe may refer to any alternative embodiment of the same element indicated by a single or double apostrophe.

[0197] The prosthetic valve 100 can be delivered to the patient's target site via a catheter (not shown) and can be configured in radial compression or coiling structures as well as radial expansion structures (e.g. Figures 1A-1BThe valve 100 can expand radially and compress between the radially compressed or coiled configurations (as shown). The expansion configuration may include a range of diameters that the valve 100 can expand to between the compression configuration and the maximum diameter achievable in the fully expanded configuration. Therefore, multiple partial expansion configurations can involve any expansion diameter between the radially compressed or coiled configuration and the maximum expansion configuration. The prosthetic valve 100 of this disclosure may include any prosthetic valve configured for implantation within a native aortic valve, native mitral valve, native pulmonary valve, and native tricuspid valve.

[0198] The term "multiple" as used in this article means more than one.

[0199] As described above, the prosthetic valve 100 can be delivered to the implantation site via a delivery assembly for installation against the native anatomical structure by means of an expanded valve 100 via various expansion mechanisms, the delivery assembly transporting the valve 100 in a radially compressed or coiled configuration toward the target site. Figure 1A An exemplary mechanically expandable valve 100' is shown, wherein Figure 1A All reference numerals marked with an apostrophe (') refer to similar elements included within a mechanically expandable valve. A mechanically expandable valve is a type of prosthetic valve that relies on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism typically includes multiple actuator assemblies releasably coupled to corresponding actuator arm assemblies of a delivery device, controlled via a handle of the delivery device for actuating the actuator assemblies to expand the prosthetic valve to the desired diameter.

[0200] Figure 1B An exemplary balloon-expandable valve 100 is shown, wherein Figure 1B All reference numerals shown with double apostrophes (") refer to similar elements included within a balloon-expandable valve. A balloon-expandable valve typically involves a 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 along with the delivery device. Although combined Figures 1A-1B Mechanically expandable valve 100' and balloon expandable valve 100" are described and illustrated, but it will be clear that the prosthetic valve 100 may include other expansion mechanisms, such as a self-expanding valve. A self-expanding valve includes a frame shaped to automatically expand once the external retaining structure (such as a portion of a sac or axis (not shown)) is retracted proximally relative to the prosthetic valve.

[0201] The prosthetic valve 100 may include an inflow portion 104 defining an inflow end 105 and an outflow portion 102 defining an outflow end 103. The prosthetic valve 100 may define a longitudinal axis 10 of the valve extending through the inflow portion 104 and the outflow portion 102. In some cases, the outflow end 103 is the proximal end of the prosthetic valve 100, and the inflow end 105 is the distal end of the prosthetic valve 100. Alternatively, depending on, for example, the method of valve delivery, the outflow end may be the proximal end of the prosthetic valve, and the inflow end may be the distal end of the prosthetic valve.

[0202] As used in this article, the term "proximal" generally refers to the location, orientation, or part of any device or part of a device that is closer to the user and further away from the implantation site.

[0203] As used in this article, the term "distal" generally refers to the location, orientation, or part of any device or part of a device that is further away from the user and closer to the implantation site.

[0204] As used herein, the term “outflow” refers to the area through which blood flows from the prosthetic valve 100 and outflows from the valve 100, such as between the valve’s longitudinal axis 10 and the outflow end 103.

[0205] As used herein, the term "inflow" refers to the area through which blood flows into the valve 100, such as between the inflow end 105 and the longitudinal axis 10 of the valve.

[0206] Valve 100 includes an annular frame 106 movable between a radially compressible configuration and a radially expanding configuration, and leaflet assemblies 130 mounted within the frame 106. The frame 106 can be made of a variety of suitable materials, including malleable materials (such as, but not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys, such as MP35N alloy)), polymers, or combinations thereof. When constructed of a malleable material, the frame 106 (such as frame 106" (and thus balloon-expandable valve 100") can be rolled into a radially compressible configuration on a delivery axis (not shown) and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, frame 106" may be made of shape memory material, such as, but not limited to, nickel-titanium alloy (e.g., nitinol). When made of shape memory material, frame 106 (such as frame 106' (and thus mechanically expandable valve 100')) can be rolled into a radially compressed configuration and constrained in the compressed configuration by means of a shaft or equivalent mechanism (not shown) inserted into the delivery device.

[0207] exist Figures 1A-1BIn the example shown, frame 106 is a ring-shaped support structure comprising a plurality of intersecting struts 110. In this application, the term "strut" includes vertical struts, inclined struts, attachment struts, connecting windows, and any similar structures described in U.S. Patent Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. Strut 110 can be any elongated member or portion of frame 106. Frame 106 can have one or more rows of units 108 defined by the intersecting struts 110. Frame 106 can have a cylindrical or substantially cylindrical shape having 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 U.S. Patent No. 9,155,619, which is incorporated herein by reference.

[0208] The end portion of the support 110 forms a vertex 120 at the outlet end 103 and a vertex 118 at the inlet end 105. The support 110 may intersect at an additional non-vertex junction 116 formed between the outlet vertex 120 and the inlet vertex 118. The non-vertex junction 116 may be spaced apart from each other and / or from the vertices 120 and 118 equally or unequally between the outlet end 103 and the inlet end 105.

[0209] According to some embodiments, the supports 110 are arranged in a grid pattern. Figure 1A In the exemplary embodiment shown, when the valve 100' is in the expanded position, the strut 110' is positioned diagonally relative to the longitudinal axis 10 of the valve, or offset at an angle, and radially offset from the longitudinal axis 10 of the valve. It will be clear that the strut 110' can be offset in addition to... Figure 1B Other angles besides those shown, such as orientations that are substantially parallel to the longitudinal axis of the valve 10.

[0210] According to some embodiments, the supports 110' are pivotally coupled to each other. The frame 106' may include openings or holes in the regions of the inflow apex 118', outflow apex 120', and non-apex junction 116' of the supports 110'. Corresponding hinges may be included at locations where the holes of the supports 110' overlap, via fasteners (e.g., rivets or pins) extending through the holes. The hinges may allow the supports 110' to pivot relative to each other as the frame 106' expands or contracts radially.

[0211] According to some embodiments, the support column 110 includes a plurality of inclined supports and vertical supports. Figure 1BIn the exemplary embodiment shown, frame 106" includes a plurality of inclined struts 110" and axially extending struts 114. In such embodiments, the struts are not necessarily coupled to each other via corresponding hinges, but may otherwise pivot or bend relative to each other to allow the frame to expand or compress. For example, frame 106" may be formed from a single piece of material (e.g., metal tubing) via various processes (such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition) while maintaining the ability to radially collapse / expand without hinges, etc.

[0212] The leaflet assembly 130 includes a plurality of leaflets 132 (e.g., three leaflets) that are at least partially located within the frame 106 and configured to regulate blood flow through the prosthetic valve 100 from the inflow end 105 to the outflow end 103. Although in Figure 1A-Figure 1B The exemplary embodiment shown depicts three leaflets 132 arranged to collapse in a tricuspid valve arrangement; however, it will be clear that the prosthetic valve 100 may include any other number of leaflets 132. The leaflets 132 are made of flexible materials derived from biological materials (e.g., bovine pericardium or pericardium from other sources), biocompatible synthetic materials, or other suitable materials known in the art and described, for example, in U.S. Patent Nos. 6,730,118, 6,767,362, and 6,908,481, which are incorporated herein by reference.

[0213] According to some embodiments, Figure 2 A single representative leaflet 132 is shown, and Figure 3 Three separate leaflets are shown prior to attachment to frame 106 and to each other, collectively defining leaflet assembly 130. Each leaflet 132 has a rounded tip portion 134 and a pair of generally oppositely oriented lugs 138. The rounded tip portion 134 defines a tip edge 135 opposite to a free edge 136, and the pair of generally oppositely oriented lugs 138 separate the tip edge 135 from the free edge 136. The tip edge 135 forms a single fan shape. Leaflet 132 further includes an inner surface 152 and an outer surface 154, the inner surface 152 being defined as a surface facing the longitudinal axis 10 of the valve, and the outer surface 154 opposing the inner surface 152 to face frame 106.

[0214] When the leaflets 132 are coupled to the frame and to each other, the lower edge of the resulting leaflet assembly 130 desiccatedly has a wavy, curved fan-shaped shape. By forming leaflets with this fan-shaped geometry, stress on the leaflets 132 is reduced, which in turn improves valve durability. Furthermore, due to the fan-shaped shape, folds and corrugations at the ventral side of each leaflet that could cause early calcification in these areas can be eliminated or at least minimized. The fan-shaped geometry also reduces the amount of tissue material used to form the leaflet structure, thus allowing for a smaller, more uniform curl profile at the valve's inflow end.

[0215] When the free edges 136 of the leaflets 132 align with each other to seal blood flow through the prosthetic valve 100, the leaflets 132 define a non-planar engagement plane (not shown). The leaflets 132 can be secured to each other at their lugs 138 to form a junction 140 of the leaflet assembly 130, which can be directly or indirectly secured to a structural element attached to or embedded in the frame 106, such as a junction post. When secured to two other leaflets 132 to form the leaflet assembly 130, the pointed edges 135 of the leaflets 132 together form the lower edge portion of the fan-shaped leaflet structure 130.

[0216] According to some embodiments, the mechanically expandable valve 100' includes a plurality of actuator assemblies 122 configured to facilitate expansion of the valve 100' and, in some cases, lock the valve in the expanded configuration to prevent unintentional recompression. Although Figure 1A The illustration shows three actuator assemblies 122 mounted to the inner surface of frame 106' and equally spaced around the inner surface of frame 106'. However, it should be understood that different numbers of actuator assemblies 122 can be used, and the actuator assemblies 122 can be mounted to frame 106' around the outer surface of frame 106', and the circumferential spacing between the actuator assemblies 122 can be unequal. In some cases, such as... Figure 1B As further shown, actuator assembly 122 can be further used as a connecting post, and connecting portion 140 of leaflet assembly 130 can be coupled to the connecting post. Details of the structure and operation of a mechanically expandable valve and its delivery system are described in U.S. Patent Nos. 9,827,093, 2019 / 0060057, 2018 / 0153689, and 2018 / 0344456, and U.S. Patent Application Nos. 62 / 870,372 and 62 / 776,348, all of which are incorporated herein by reference.

[0217] According to some embodiments, for example Figure 1BIn the exemplary embodiment shown, the uplink unit includes a plurality of axially extending window frame portions 112 (which define joint windows) 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 inclined struts 110" to another joint 116" defined by the convergence of the upper ends of the two inclined struts 110". Each joint window frame portion 112 is fitted with a corresponding joint 140 of the leaflet structure 130.

[0218] Alternative frame constructions may include connecting posts attached to the frame, the connecting posts being configured to receive connecting portions 140 extending through a window portion defined therein, or supporting connecting portions attached thereto in various other ways. Alternatively, some units 108 may be configured to receive connecting portions 140 attached thereto. For example, the uppermost unit 108 may be configured to receive lugs 138 of leaflets 132. Further details regarding prosthetic valves (including the manner in which the syndesm can be mounted to its frame) are described in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,252,202, and 9,393,110; U.S. Publications Nos. 2018 / 0325665 and 2019 / 0105153; U.S. Application Nos. 62 / 869,948 and 62 / 813,643; and PCT Application No. PCT / US2019 / 61392, all of which are incorporated herein by reference. Any technique or mechanism disclosed in the prior art can be used to connect the syndesm 140 directly or indirectly to the frame 106.

[0219] According to some embodiments, the prosthetic valve 100 may further include a skirt 123, such as an outer skirt 124 (e.g. Figure 15 and Figure 17 As shown, it is mounted on the outer surface of the frame 106 and configured, for example, to serve as a sealing member between the frame 106 and the surrounding tissue of the prosthetic valve 100 against which it is mounted, thereby reducing the risk of paravalvular leakage through the prosthetic valve 100. This outer skirt can be made of a variety of suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or native tissue (e.g., pericardial tissue).

[0220] According to some embodiments, the primary suture 144 passes through the tip portion 134 in an in-and-out pattern, also referred to in the art as a straight line pattern. Figure 3 A primary suture 144 is shown, which is sutured along the tip portion 134 of the leaflet 132. Figure 4An enlarged cross-sectional view of the primary suture 144 passing through the tip end portion 134 is shown. As shown, straight stitches extend along the tip end portion 134 in an in-and-out pattern through the penetration point 150, thereby defining a plurality of straight stitch portions, including a plurality of inner stitch portions 146 disposed along the inner surface 152 of the leaflet and a plurality of outer stitch portions 148 disposed along the outer surface 154 of the leaflet, wherein each inner stitch portion 146 and each outer stitch portion 148 is defined between a pair of consecutive penetration points 150. Optionally, but preferably in some embodiments, the primary suture 144 follows the curvature of the tip edge 135, meaning that the primary suture 144 travels along or is substantially parallel to the tip edge 135.

[0221] Specific reference Figures 5A-5E Exemplary techniques for coupling leaflets 132 along their tip portion 134 to at least one segment of at least one strut 110 of the frame 106 will now be discussed in accordance with this teaching. Figure 5A As shown, a tip portion 134 of a primary suture passing through it in an in-and-out pattern approaches the post 110, such that the tip portion 134 is preferably positioned radially inward on the inside of the post 110 (and optionally in contact with the inside of the post 110). According to some embodiments, a secondary suture 156 sutures through the primary suture 144 and around at least one segment of at least one post 110, wherein the secondary suture 156 includes a plurality of self-tightening structures 158. Each self-tightening structure 158 includes at least one loop configured to contract around the post 110 under tension.

[0222] Although pillar 110 is Figures 5A-5E The cross-section is shown as rectangular, but it will be clear that this is for illustrative purposes only, and the cross-section of the support 110 may have a rounded shape, a circular shape, a polygonal shape, an irregular shape, or a shape that varies along the length of the support. The cross-section of the support may also maintain the same shape, but vary in size along the length of the support.

[0223] By passing the secondary suture 156 radially outward through the primary suture 144 at the penetration point 150a and forming at least one loop 160 around the pillar (such as... Figure 5B The loop 160a shown forms a self-tightening structure 158. According to some embodiments, the self-tightening structure 158 includes more than one loop 160 surrounding the support 110. For example, the secondary suture can be looped again to form a second loop 160b surrounding the support 110, such as... Figure 5C As shown. It will be clear that, although combined Figures 5A-5ETwo rings 160a and 160b are described and illustrated, but in alternative variations, the self-tightening structure 158 may include any other number of rings.

[0224] like Figure 5D As shown, the secondary suture 156 then passes beneath at least one loop 160 (such as between the two loops 160a, 160b and the strut 110) to form a generally horseshoe-shaped or U-shaped segment 162, which subsequently passes radially inward through the primary suture 144 at the penetration point 150b. Thus, the resulting self-tightening structure 158 is defined between the two penetration points 150, which define at least one outer stitch portion 148 therebetween.

[0225] The "radial inward" direction is towards the valve's longitudinal axis 10, while the "radial outward" direction is oriented away from the valve's longitudinal axis 10 and in the opposite direction.

[0226] The secondary suture 156 further includes a plurality of suture pulling portions 164 extending on the inner surface 152 of the leaflet, and may be defined between continuous self-tightening structures 158. Figure 5E As shown, the secondary suture 156 is defined by extending the secondary suture 156 on the inner surface 152 of the leaflet, for example, parallel to at least one inner suture portion 146, and then passing the secondary suture 156 again through the primary suture 144 in a radially outward direction at a successive penetration point 150c (where another self-tightening structure 158 can be formed in a similar manner). Figure 5E A portion of a line pattern including three exemplary self-tightening structures 158 is shown.

[0227] The self-tightening structure 158 is configured such that the more its tip portion 134 is pulled radially inward, the tighter its clamping on the leaflet 132. During diastole, the leaflet 132 collapses radially inward to effectively close the prosthetic valve. This collapse applies a radially inward-oriented pulling force in the tip portion 134, which tends to pull the suture pulling portion 164 radially inward. The suture pulling portion 164, located on the inner surface 152 of the leaflet, extends along its tail on both sides of each self-tightening structure 158, causing at least one ring 160 to contract around the strut 110. This contraction reduces the diameter of at least one ring 160, thereby forming a mechanical interface between the outer surface of the strut 110 and the inner surface of at least one ring 160. This contraction results in static friction between the inner and outer surfaces at the mechanical interface, causing at least one ring 160 of each self-tightening structure 158 to tighten in a configuration that can maintain tension or a reduced diameter. In other words, the ring 160 is configured to decrease in diameter when tension is applied to the two end portions of the self-tightening structure 158, which increases the clamping of the secondary suture 156 around the strut 110, thereby preventing the leaflet 132 from sliding along the resulting fan-shaped line on the strut 110.

[0228] Advantageously, the primary suture 144, which passes through the tip portion 134 with an in-and-out pattern, can be used as filler or padding between the secondary suture 156 and the leaflet 132. For example, the suture pull portion 164 disposed on the inner surface 152 of the leaflet can be pressed against the inner stitch portion 146 of the primary suture 144 during repeated cardiac systole and diastole cycles, the inner stitch portion 146 serving as filler or padding to prevent direct abrasion that may otherwise be applied to the leaflet 132.

[0229] As used herein for primary suture 144 or secondary suture 156 (and secondary suture 170 further described below), the term "suture" includes, but is not limited to, polymeric materials, threads, cords, fibers, filaments, other coilable materials, organic and inorganic materials, or any other material acceptable for medical applications for threading and / or bonding components used in various embodiments of valve 100. Primary suture 144 may be a multifilament suture, such as Ethibond... PET sutures (Johnson & Johnson, New Brunswick, NJ) and other types of sutures. Secondary sutures 156 (and secondary sutures 170, which will be further described below) may include ultra-high molecular weight polyethylene (UHMwPE), such as FORCE. Sutures (Teleflex, Wayne, Pa) or Fiber (Koninklijke DSM, the Netherlands) and other types of sutures.

[0230] Preferably, the diameter of the secondary suture 156 is sufficiently smaller than the diameter of the primary suture 144, such that passing the secondary suture 156 through the primary suture 144 will not tear or damage the primary suture 144. The ratio of the diameter of the secondary suture 156 to the diameter of the primary suture 144 is defined as the secondary to primary suture diameter ratio. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.8. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.5. According to some embodiments, the secondary to primary suture diameter ratio is less than 0.3.

[0231] In existing prosthetic valve devices, the inner skirt is attached to the inner surface of the frame to form a more suitable attachment surface for the leaflet. In contrast, the currently disclosed attachment configuration does not require the use of an intermediate fabric strip because the primary suture 144 serves as a support structure through which the leaflet 132 can be attached to the frame 106 via a secondary suture 156 passing through the primary suture 144. Fabric strips along the inner surface of the frame 106 pose a risk of promoting inward tissue growth and proliferation after implantation. Therefore, the absence of such fabric or cloth components along the inner side of the frame significantly reduces this risk, thereby improving the long-term durability and functionality of the valve.

[0232] According to a preferred embodiment of the invention, the leaflet is attached to the frame of the prosthetic valve along the fan-shaped edge of the leaflet without any intermediate fabric strips and / or cloth in between. Although inward tissue growth can still occur along the suture material (such as primary suture 144), the total surface area of ​​the suture is significantly smaller than that of conventionally used fabric strips, such as those used as inner skirt components.

[0233] As shown, the attachment of leaflet 132 to the support 110 of frame 106 is achieved via secondary suture 156, which passes through primary suture 144 instead of directly through the leaflet material. Therefore, primary suture 144 serves as a reinforcing member against suture tearing along the tip portion 134, thereby reducing stress concentration on leaflet 132 near the fan-shaped line. Advantageously, the force applied to leaflet 132 during the transition between an open and closed or engaged state in the area where leaflet is attached to the frame is distributed along the length of primary suture 144. In this way, primary suture 144 serves as a force-distributing element that increases the durability of leaflet 132 over time, because the force is distributed substantially equally along its length.

[0234] Return for further reference Figure 2 In some embodiments, leaflet 132 may be provided with a series of holes 142 pre-formed along its tip portion 134, the holes 142 being configured to receive primary sutures 144 and define penetration points 150 through which the primary sutures 144 can extend in and out of the pattern. In such embodiments, the holes 142 may serve as penetration points 150. In some embodiments, the holes 142 may be equally spaced from each other.

[0235] The secondary suture 156 passes through the primary suture 144 at the penetration point 150, possibly within the hole 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 penetration points 150, as will be further disclosed below.

[0236] Since in such an embodiment the primary suture 144 passes through a pre-formed hole 142 along the tip portion 134, the accuracy of the penetration point 150 of the primary suture 144 and / or the secondary suture 156 can be preset respectively, resulting in more accurate placement of the sutures and less error.

[0237] Holes 142 are sized to receive primary sutures 144. According to some embodiments, the diameter of the holes 142 is equal to or smaller than the diameter of the primary sutures 144, such that each hole 142 tightly holds the primary suture 144 extending through it as it passes through. Since the secondary sutures 156 extend the boundary of the primary sutures 144 outwards at the penetration area, alternative embodiments may include holes 142 having a diameter equal to or smaller than the combined diameter of the primary sutures 144 and the secondary sutures 156, such that the holes 142 tightly hold both the primary sutures 144 within them as the secondary sutures 156 extend through them.

[0238] According to some embodiments, the tip portion 134 includes markings that can follow a wavy, fan-shaped profile, such as by tracing the curvature of the tip edge 135. Such markings, which can be used as an alternative to or in addition to the hole 142, can further assist the assembler in suturing the primary suture line 144.

[0239] According to some embodiments, such as Figure 5E As shown, the secondary suture 156 passes through all consecutive penetration points 150, such that each self-tightening structure 158 is positioned on a single outer stitch portion 148, and each suture pull portion 164 spans the length of a single inner stitch portion 146.

[0240] According to an alternative embodiment, the secondary suture 156 does not necessarily pass through all consecutive penetration points 150, and may actually skip one or more penetration points 150, such that a single suture pull portion 164 may span more than one inner stitch portion 146 or outer stitch portion 148. Figure 6 An exemplary configuration is shown in which each self-tightening structure 158 is positioned on a single outer stitch portion 148 while a suture pulling portion 164 spans two inner stitch portions 146 and the single outer stitch portion 148 positioned therebetween. It should be understood that other configurations in which the self-tightening structure 158 and / or the suture pulling portion 164 pass through discontinuous penetration points 150 are contemplated.

[0241] The term "discontinuous penetration point" refers to any pair of penetration points that includes at least one additional penetration point 150 between them. Advantageously, the self-tightening construction of the secondary suture 156 allows it to pass through the discontinuous penetration point 150 while maintaining sufficient clamping to prevent or at least significantly reduce lateral movement of the tip portion 134 on the strut 110. Thus, the number and location of the self-tightening structures 158 can be designed and modified in various ways based on the desired attachment point, and facilitate easier attachment of the valve 100 by the assembler.

[0242] According to some embodiments, two primary sutures 144 pass through the same penetration point 150 in opposite directions in the pattern. Figure 7 A cross-sectional view of the tip portion 134 is shown, which is similar to... Figure 4 The view shown shows two primary sutures 144a and 144b passing through the same penetration point 150 in opposite directions, such that each pair of consecutive penetration points 150 defines an inner stitch portion 146 of one primary suture and an outer stitch portion 148 of the other primary suture. Figure 8 It shows the sutures passing through two primary sutures 144 (as shown). Figure 7 The secondary suture 156 of the tip portion 134 (shown). Advantageously, this configuration results in a pattern in which the outer stitch portion 148 and the inner stitch portion 146 extend between each pair of successive penetration points 150, thereby simplifying the assembly process by allowing the assembler to pass the secondary suture 156 through any readily available penetration point 150 during such a procedure.

[0243] According to some embodiments, the diameter of the hole 142 is equal to or less than the diameter of the two primary sutures 144, such that each hole 142 tightly holds both of them together when the two primary sutures 144 extend through it. Since the secondary suture 156 extends the boundary of at least one primary suture 144 at the penetration area outward, alternative embodiments may include a hole 142 having a diameter equal to or less than the combined diameter of the two primary sutures 144 and the secondary suture 156.

[0244] Typically, passing a suture through the leaflet 132 involves using a needle or other sharp tool capable of piercing through it. However, the use of a needle or other sharp tool can result in accidental cutting, perforation, or other damage to the leaflet 132. Such damage is also difficult for the manufacturer to foresee or predict, and may be difficult for the end user to detect even when it occurs. The primary suture 144 passes through the penetration point 150 in an in-and-out manner, and the penetration point 150 also serves as the penetration site for the secondary suture 156. Therefore, when the secondary suture 156 passes through the primary suture 144 without directly entering the leaflet, further penetration or cutting of the leaflet can be avoided. Advantageously, the proposed arrangement allows the leaflet 132 to be attached to the support of the frame using the secondary suture 156 without further piercing the leaflet tissue, thereby improving the long-term durability of the leaflet.

[0245] According to any of the embodiments described above, the suture pattern including the self-tightening structure 158 for directly attaching the leaflet 132 to the strut 110 of the frame 106 can be implemented for any type of prosthetic valve 100, such as a mechanically expandable valve 100' or a balloon-expandable valve 100". However, the advantages of the self-tightening structure 158 for Figure 1A The mechanically expandable valve 100' of the type shown is more prominent, and is illustrated as comprising two intersecting struts 110', namely an inner strut and an outer strut, that intersect at a junction 116' (e.g., via a pin or other hinge). A unique challenge of this double-layered frame 106' is the difficulty in forming knots in the sutures at the pivot junction 116', because the relative movement between the intersecting struts 110' can exert scissor-like shearing forces that can compromise the integrity of the sutures in this area.

[0246] With mechanically expandable valves (such as Figure 1A The double-layered frame 106' of the valve 100' shown is different from the frame of the prosthetic valve (e.g., the frame of the valve with an integral frame). Figure 1BThe frame 106" of the balloon-expandable valve 100" shown will not suffer from this problem with the same effect, and the suture pattern for directly coupling the leaflet 132 to such frame 106" may include a knot formed around the non-apex junction 116" in a manner that will maintain a tight attachment between them without having to use a self-tightening structure.

[0247] Specific reference Figures 9A-9D Exemplary techniques for coupling leaflets 132 along their tip end portion 134 to strut segments 111 interconnected at non-apex junctions 116 will now be discussed in accordance with this teaching. Figures 9A-9D The view shown is taken from a bottom-view perspective of a segment of the prosthetic valve (such as a segment of prosthetic valve 100"). As used herein, strut segment 111 refers to any segment of the strut defined between the two non-apex joints 116 of the frame 106.

[0248] Figure 1B The exemplary balloon-expandable valve 100" frame 106" shown is illustrated as including a flat inflow apex 118" (and a flat outflow apex 120"). In some embodiments, the strut segment may be a relatively linear strut segment (such as) extending between two non-apex joints (such as non-apex joints 116"b and 116"c) that are axially spaced apart from each other. Figure 1B The shown support section 111"b), and / or a curved support section (such as support section 111"a) extending between two non-apex joints (such as non-apex joints 116"a and 116"b) that are laterally spaced from each other but aligned with each other at the same height level between the inlet end 105" and the outlet end 103'. In such an embodiment, the peak of curvature of the curved support section may define an apex, such as the inlet apex 118"a defined by the curved support section 111"a.

[0249] like Figure 9A-9B As shown, each strut segment 111 and each non-apex junction 116 are defined between opposing axial sides and opposing radial sides. For example, each strut segment 111 is defined between a proximal strut side 190 facing the outflow end 103 and a distal strut side 191 facing the inflow end 105 (sides 190 and 191 are opposing axial sides of the strut segment). Each strut segment 111 is also defined between an inner strut side 192 facing the longitudinal axis 10 of the valve and an outer strut side 193 facing away from the axis 10 (sides 192 and 193 are opposing radial sides of the strut segment). If the strut has as Figures 5A-6Given the rectangular cross-sectional profile shown in the example, each of sides 190, 191, 192, and 193 can be defined by a corresponding flat surface of the support. However, as mentioned above, other cross-sectional shapes for the support are considered, such that the sides may not necessarily include flat surfaces.

[0250] Each non-apex junction 116 is defined between a proximal junction 194 facing the outflow end 103 and a distal junction 195 facing the inflow end 105 (sides 194 and 195 are the opposing axial sides of the junction). Similarly, each non-apex junction 116 is defined between an inner junction 196 facing the longitudinal axis 10 of the valve and an outer junction 197 away from the axis 10 (sides 196 and 197 are the opposing radial sides of the junction). Each junction is also defined between two opposing lateral sides (i.e., a first lateral side 198 and a second lateral side 199 of the junction). In the illustrated example, two strut segments 111 converge on each lateral side of the non-apex junction 116.

[0251] Primary suture 144 can be combined with the above. Figure 4 The same manner described is used to pass through the tip portion 134 in the pattern entry and exit. In some embodiments, two primary sutures 144a and 144b are used to join with the above. Figure 8 The method described is similar, passing through the penetration point 150 in the opposite direction. Therefore, in conjunction with the following... Figures 9A to 10 Any reference to primary sutures in the description may refer to the construction of a single primary suture or to two oppositely passing sutures with equal force.

[0252] like Figure 9A-9B As shown, a tip portion 134 of a primary suture 144 passing through it in an in-and-out pattern approaches the support section 111, such that the tip portion 134 is preferably positioned radially inward on (and optionally in contact with) the inner side 192 of the support. A secondary suture 170 is stitched through the primary suture 144 and around the support section 111 in a manner forming a series of loops or seam stitches 172 spaced apart from each other along the length of the support section 111. 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 instead wraps around at least one support section 111 by a series of seam stitches and includes at least one seam lock 174 around at least one non-apex seam 116, as will be described in more detail below.

[0253] The secondary suture 170 is passed through the primary suture 144 at the penetration point 150, the secondary suture 170 is extended around the support section 111 and back toward the primary suture 144, and then the secondary suture 170 is passed through the primary suture 144 again at the successive penetration point 150 (where another suture stitch can be formed in a similar manner), forming the suture stitch 172.

[0254] For example, by penetrating point 150 (at Figure 9B The diagram shows a secondary suture 170 (between rings 172a and 172b) passing radially outward through the primary suture 144, wrapping around the support segment 111 (in the illustrated example, radially outward above the proximal side 190 of the support, and then radially inward along the outer side 193 of the support, which is hidden from view, and radially inward above the distal side 195 of the support) and extending back towards the primary suture 144 (along the inner side 192 of the support), forming... Figure 9B The suture 172b shown is passed through the next sequential penetration point 150 to form the next suture 172c in a similar manner. In some embodiments, such as in the illustrated example, the primary suture 144 is positioned proximal to or near the proximal side 191 of the post.

[0255] Passing the seam stitch 172 through the continuous penetration points 150 results in a series of slanted seam stitches. The slanted seam stitches can be defined as stitches having at least one portion extending between opposite sides of the support section 111, oriented at a non-perpendicular angle relative to the axis of the support section, which is defined as being tangent to the support section 111 at the region of the corresponding stitch.

[0256] exist Figure 9A-9B In the illustrated embodiment, the portion of the seam stitch 172b extending along the outer side 193 of the post between the proximal side 190 and the distal side 191 of the post (this portion is in...) Figure 9B The portion extending along the distal side 191 of the support between the outer side 193 and the inner side 192 of the support, and the portion extending along the inner side 192 of the support between the distal side 191 and the proximal side 190 of the support (optionally at least partially on the inner surface 152 of the leaflet), are oriented at a non-perpendicular angle relative to the axis of the support segment tangent to the support 111a at the region of the seam stitch 172b.

[0257] Therefore, each inclined seam stitch 172 has a portion extending over one axial side of the thus wound support segment 111, which is closer to the joint 116 (at the end of the respective support segment) than the corresponding portion extending over the opposite axial side of the support segment. In the illustrated example, the portion of the seam stitch 172 extending over the proximal side 190 of the support segment 111a is closer to the joint 116b than the corresponding portion extending over the distal side 191 of the support. Alternatively, the opposite orientation of the seam stitch 172 may include a portion extending over the distal side 191 of the support, which is closer to such a joint 116 than the portion extending over the proximal side 190 of the support. A series of seam stitches 172 wound around a single support segment 111 defined between two joints 116 will follow substantially the same inclined orientation.

[0258] Preferably, the diameter of the secondary suture 170 is sufficiently smaller than the diameter of the primary suture 144 such that passing the secondary suture 170 through the primary suture 144 will not tear or damage the primary suture 144. The ratio of the secondary to primary suture diameters of the secondary suture 170 can be defined in the same manner as described above regarding the secondary suture 156. According to some embodiments, the ratio of the secondary to primary suture diameters is less than 0.8. According to some embodiments, the ratio of the secondary to primary suture diameters is less than 0.5. According to some embodiments, the ratio of the secondary to primary suture diameters is less than 0.3.

[0259] like Figure 9B As shown, these steps are repeated to form a series of inclined seam stitches 172 (such as stitches 172a, 172b, 172c) until the final seam stitch 172n, which is defined as the non-apex joint 116 on the end closest to the end of the support section 111. Figure 9B The suture stitch of the joint 116b) in the middle, wherein the final suture stitch 172n extends to the final penetration point 150n, after which a joint lock knot 174 is formed on the corresponding non-apex joint 116 using a secondary suture 170.

[0260] The locking joint 174 includes a transition section 176, a first ring 178, and a second ring 180. The transition section 176 extends along one axial side of the joint 116 in a direction from the first lateral side 198 of the joint to the second lateral side 199 of the joint. Figure 9BIn the example shown, the secondary suture 170 extends from the final penetration point 150n at the proximal side 190 of the post to the distal side 191 of the post near the first transverse side 198 of the joint 116b, over the outer side 193 of the post section 111a. Then, a transition section 176 is formed by extending the secondary suture 170 along the distal side 195 of the joint in a diagonal direction (e.g., radially inward from the outer side 197 of the joint toward the inner side 196 of the joint and laterally from the first transverse side 198 of the joint to the second transverse side 199 of the joint).

[0261] A first ring 178 is then formed by extending a secondary suture 170 around a support segment 111 extending from the second side 199 of the joint. Support segments 111b and 111m are shown extending from the second transverse side 199 of the joint 116b. Figures 9B-9C In the example shown, the first loop 178 is formed by extending the secondary suture 170 from the transition section 176 around the support section 111m.

[0262] The second ring 180 is formed by passing the tail of the secondary suture 170 through the first ring 178 between the transition section 176 and the junction 116 and then looping it back to extend through the first ring 178. Figure 9C In the example shown, the secondary suture 170 extending from the first loop 178 passes through in the axial direction (e.g., upward toward the outlet end 103) and then folds backward (e.g., in the distal / downward direction) over itself, passing through the first loop 178. The tail of the secondary suture is then forcibly pulled to tighten the two loops 178, 180 and lock the resulting knot 174.

[0263] This procedure can then be repeated by forming a series of suture stitches 172 that attach the leaflet 132 to a subsequent strut segment 111 (e.g., strut segment 111b) extending from the junction 116, and forming similar junction knots 174 on all corresponding junctions 116 along a path of rounded tip portion 134. Advantageously, this type of stitch pattern facilitates the valve assembly procedure because the knots 174 surrounding the junction 116 maintain a tight connection between the leaflet and the junction during assembly.

[0264] Compared to traditional assembly procedures that require the assembler to maintain tension on the stitches as each subsequent stitch is formed along the entire circumference of the frame, the joint lock 174 maintains a tight connection of all the stitches 172 around the support section 111 leading to the corresponding joint 116, so that the assembler does not need to keep all the previous stitches taut and even allows the assembly procedure to continue at a later time without the risk of any previous loops of the knot loosening.

[0265] The tight connection of knot 174 ensures that all sutures 172 leading to the strut segment 111 are also tightly connected to the strut segment 111, thereby reducing relative movement between sutures 170 and strut segment 111 during normal operation of valve 100 after implantation.

[0266] Any joint knot 174 is also separated among a series of suture stitches 172 surrounding the strut segments 111 extending from both sides of the joint 116. Therefore, the orientation of the angled suture stitches 172 formed after the joint knot 174 does not depend on the construction of the suture stitches 172 leading to the knot 174, and can indeed have similar or different angular orientations, as well as similar or different suture densities, etc. This allows the assembler to switch the angular orientation of the angled suture stitches in any desired direction that may be convenient during the assembly procedure, and the angular orientation may differ for different strut segments 111 along the circumference of the valve 100.

[0267] Figure 10 An example of a portion of the leaflet assembly 130 sutured to frame 106 is shown (viewed from the inside of the valve). As shown, this procedure can be repeated to attach one or more additional leaflets 132 to the strut segment 111 and the junction 116, including a similar junction lock 174 around the junction 116 interconnecting two adjacent leaflets 132 (such as...). Figure 10 The formation of the joint portion 116d, which is aligned with the joint portion 140 between leaflets 132a and 132b.

[0268] In the illustrated view, the tip portion of leaflet 132a is sewn to support sections 111a, 111b, and 111c, and the tip portion of leaflet 132b is sewn to support sections 111d, 111e, and 111f. As shown, the angular orientation of the suture stitches 172 around support sections 111a, 111b, and 111c is generally similar (so that its upper / proximal end is closer to the joint 116d, for example, than its lower / distal end). After the joint lock 174 around joint 116d, the orientation of the suture stitches 172 around support sections 111d and 116e is reversed to a generally opposite direction, and as shown, after the joint lock 174 around joint 116f, the orientation of the suture stitches 172 around support section 111f is switched again (to an orientation similar to that of the suture stitches forming loops on support sections 111a-c). The ability to individually change the orientation of the suture stitches wrapped around each strut segment can facilitate the valve assembly process.

[0269] In some cases, it may be preferable to attach the leaflet 132 to the frame 106 using a secondary suture 156 that does not penetrate through the leaflet 132 and / or through the primary suture 144. Figures 11A-11D An exemplary technique for coupling leaflet 132 along its tip portion 134 to support section 111 is shown. Figures 11A-11D The view shown is taken from a downward viewpoint of a segment of the prosthetic valve (such as a 100" segment of the prosthetic valve), similar to... Figures 9A-9D From that perspective.

[0270] Primary suture 144 can be combined with the above. Figure 4 The same manner described is used to pass through the tip portion 134 with an in-and-out pattern, forming multiple straight line trace portions, including an inner line trace portion extending above the inner surface of the leaflet (hidden from view) and an outer line trace portion 148 extending above the outer surface 154 of the leaflet between the penetration points 150 (such as...). Figure 11A The outer stitches shown are 148a, 148b, and 148c. In some embodiments, two primary sutures 144a and 144b are used in conjunction with the above. Figure 8 The method described is similar, passing through the penetration point 150 in the opposite direction. Therefore, in conjunction with the following... Figures 11A-11D Any reference to primary sutures in the description may refer to the construction of a single primary suture or to two oppositely passing sutures with equal force.

[0271] like Figure 11A As shown, the tip portion 134 of the primary suture 144, which passes through it in an in-and-out pattern, approaches the support section 111, such that the tip portion 134 is preferably positioned radially inward on (and optionally in contact with) the inner side 192 of the support. The secondary suture 170 loops around the outer stitch portion 148 of the primary suture 144 and around the support section 111 to form a series of non-penetrating suture stitches 182 spaced apart from each other along the length of the support section 111. The secondary suture 170 can be joined in a manner similar to the above. Figures 9A-9D Any of the embodiments described, except Figures 11A-11D The secondary suture in the illustrated embodiment is used to form a non-penetrating suture 182, rather than a conventional suture 172 extending from one side of the leaflet to the other (e.g., from the inner surface 152 of the leaflet to its outer surface 154).

[0272] Unlike the suture stitch 172, the non-penetrating suture stitch 182 does not cross the primary suture 144 at the penetration point 150 or in any other area of ​​the primary suture 144, and does not cross the leaflet from one side to the other. The non-penetrating suture stitch 182 is formed by looping the secondary suture 170 around the support segment 111 to create the support wrapping segment 184, and then looping the secondary suture around the outer stitch portion 148 to create the primary suture wrapping segment 186. This can be repeated to form a series of subsequent non-penetrating suture stitches 182 along the support segment 111 in a similar manner.

[0273] For example, Figure 11A Two non-penetrating suture stitches 182a and 182b are shown, each suture stitch including a corresponding support wrapping section 184 and a corresponding primary suture wrapping section 186. (See diagram) Figure 11B As shown, a subsequent non-penetrating suture 182c is formed by looping the tail of the secondary suture 170. The tail of the secondary suture 170 extends from the primary suture wrapping section 186b (looping around the outer stitch portion 148b), around the support section 111, and back toward the subsequent stitch portion 148c of the primary suture 144.

[0274] exist Figures 11A-11B In the example shown, the secondary suture 170 is folded over the corresponding axial side of the strut (e.g., on the distal side 191) by extending it across a radial side of the strut segment (e.g., the outer side 193 of the strut) from an axial side of the strut to the opposite axial side (e.g., from the proximal side 190 of the strut to the distal side 191 of the strut) and then extending it across the opposite radial side (e.g., the inner side 192 of the strut) toward the primary suture 144 (e.g., from the distal side 191 of the strut toward the proximal side 190 of the strut) to form the strut wrapping segment 184c.

[0275] like Figure 11B As further shown, the secondary suture 170 then passes below the continuous outer stitch portion 148c, between the outer stitch portion and the leaflet 132 (i.e., between the outer stitch portion 148 and the inner surface 152 of the leaflet). Figure 11C As shown, the secondary suture 170 is then folded over the outer stitch portion 148c, thereby forming the primary suture wrapping section 186c. The suture can then cross the support section 111 (such as in...). Figure 11C In the example shown, the steps are repeated across the outer side 193 of the support towards the far side 191 of the support to form subsequent non-penetrating seam stitches 182 (such as non-penetrating seam stitches 182d).

[0276] like Figure 11DAs shown, this procedure can be repeated until the final non-penetrating suture stitch 182n is reached. The final non-penetrating suture stitch 182n is defined as the suture stitch of the non-apex joint 116 on the end closest to the end of the support section 111, wherein the secondary suture 170 can be used to follow the above joint. Figures 9A-9D The same steps described form the joint lock 174, except that the transition zone 176 of the joint lock 174 extends from the final primary suture wrapping section 186n of the final non-penetrating suture stitch 182n instead of from the final penetration point 150n.

[0277] Figures 12A to 12D Another exemplary technique is shown for coupling leaflet 132 along its tip portion 134 to post section 111 via a series of non-penetrating stitches 182, which can be combined with Figures 11A-11D The technique described is the same, except that the secondary suture 170 extending from the support wrapping section 184 passes under the outer stitch portion 148 and is then folded over the outer stitch portion 148 to form the primary suture wrapping section 186 (as shown). Figures 11B-11C As shown), the secondary suture 170 passes over the outer stitch portion 148 (see...). Figure 12B ), and then fold it underneath (i.e., between the outer stitch portion 148 and the inner surface 152 of the leaflet). All other steps and embodiments can be similar to the combination above. Figures 11A-11D The steps and embodiments described herein will not be described further for the sake of brevity.

[0278] Figure 13 It shows the relationship with Figures 12A-12D Another suture construction similar to the one shown is provided, except that two non-penetrating suture stitches 182 pass through each outer stitch portion 148. In the illustrated example, the non-penetrating suture stitch 182a' includes a support wrapping section 184a' looping around the support section 111, and a primary suture wrapping section 186a' extending therefrom and looping around the outer stitch portion 148a. A secondary suture 170 then extends to form the support wrapping section 184a' of the non-penetrating suture stitch 182a' and the primary suture wrapping section 186a' looping around the same outer stitch portion 148a.

[0279] The secondary suture 170 then extends in a similar manner to form subsequent non-penetrating sutures 182b' and 182b', causing its primary suture wrapping segments 186b' and 186b' to loop around the outer suture portion 148b. It should be understood that, although in Figure 13The diagram illustrates two non-penetrating stitches 182 passing through a single outer stitch portion 148, but any other number of non-penetrating stitches 182 can pass through any single outer stitch portion 148 in a similar manner.

[0280] Figure 14 It also shows that Figures 12A-12D Another suture construction similar to the one shown is provided, except that each non-penetrating suture 182 further includes a support looping section 185 extending from the corresponding primary suture wrapping section 186 and looping only over the support section 111. In the illustrated example, the non-penetrating suture 182a includes a support wrapping section 184a looping around the support section 111, a primary suture wrapping section 186a extending therefrom and looping around the outer suture portion 148a, and a support looping section 185a extending from the primary suture wrapping section 186a and looping around the support section again.

[0281] In the specific illustrated example, a pillar looping section 185a is formed by extending a secondary suture 170 from the primary suture wrapping section 186a across one radial side of the pillar section (such as the outer side of the pillar 193), around the distal side of the pillar 191, on another radial side (such as the inner side of the pillar 192), toward and over the proximal side of the pillar 190. The secondary suture is then extended to form the pillar wrapping section 184b, the primary suture wrapping section 186b, and the pillar looping section 185b, which together form the subsequent non-penetrating suture stitch 182b in a similar manner. It should be understood that although a single pillar looping section 185 is illustrated in the example, the non-penetrating suture stitch 182 can similarly comprise multiple single pillar looping sections 185 looped one after another around the pillar section 111 prior to the formation of the subsequent non-penetrating suture stitch 182.

[0282] It should be understood that the above description and Figures 11A-14 The illustrated primary suture wrapping section 186, which loops around the outer stitch portion 148, is unbound, and any primary suture wrapping section 186 can loop around any straight stitch portion (including the inner stitch portion 146 around the primary suture 144). In some embodiments, the tip 134 can be folded over itself such that the tip edge 135 rests against the outward-facing leaflet outer surface 152, thus concealing the outer stitch portion 148 and allowing the inner stitch portion 146 to face the support section 111. In such embodiments, non-penetrating sutures can be formed in the same manner as described above, except that the secondary suture loops around the inner stitch portion 146 instead of the outer stitch portion.

[0283] It should be understood that various suture constructions can be combined to attach one or more leaflets 132 to the strut segment 111 of the same prosthetic valve 100. For example, attaching a leaflet 132 along its rounded apical end portion 134 to one or more strut segments 111 may include one or more individual non-penetrating suture stitches 182 passing through the corresponding straight stitch portion (e.g., Figures 12A-12D As shown), and one or more double non-penetrating stitches 182 pass through the corresponding single straight stitch portion (as shown). Figure 13 (as shown), and / or one or more individual non-penetrating seam stitches 182 loop twice around the support section 111 (as shown). Figure 14 (As shown) combinations. Single or combined pattern constructions can be implemented along the same strut segment 111 or around different strut segments of the same valve.

[0284] Because the damage to the leaflet material is reduced due to the fact that the secondary suture 170 does not need to penetrate through the tissue material, attaching the leaflet 132 to the frame 106 and more specifically to the support segment 111 of the frame 106 by non-penetrating suture 182 can advantageously improve the long-term durability of the leaflet and its attachment to the frame along the fan line.

[0285] Although the attachment of leaflet 132 to frame 106 has been described and illustrated above with non-penetrating suture stitch 182 having or without joint lock 174, this attachment construction can be similarly used to attach other soft parts of valve 100 to frame 106, such as skirt 123 which may include either inner skirt (not shown) or outer skirt 124.

[0286] Figure 15 A prosthetic valve 100 having an outer skirt 124 is shown according to some embodiments. The prosthetic valve can be similar in all respects to a combined valve. Figure 1B The prosthetic valve 100" is described, and for the sake of brevity, will not be described further. Skirt 123 (such as...) Figure 15 The outer skirt portion 124 shown extends between the proximal end 128 and the distal end 129 of the skirt portion, and defines an inner skirt surface 125 facing the frame 106 (and at least partially in contact with the frame 106) and an opposing outer skirt surface 126 facing away from the frame (facing the native anatomy when implanted in the patient's body).

[0287] In some embodiments, such as Figure 15 As further shown, the proximal end of the outer skirt follows a Z-shaped pattern, corresponding to the Z-shaped pattern of the support segment 111 to which it can be sewn. Figure 15In the specific exemplary embodiment shown, the distal end 128 of the skirt is substantially linear (e.g., straight when the skirt flattens), meaning that it remains circumferentially positioned around the inflow portion 104 of the valve 100 at the same axial level.

[0288] In some embodiments, one or more primary stitches 144 are used to stitch the skirt 123 along the portion of the skirt 123 aligned with the support section 111 of the frame 106 in an in-and-out pattern stitch, and one or more secondary stitches 170 form a plurality of non-penetrating seam stitches 182 to couple the skirt 123 to the support section 111 of the frame 106.

[0289] According to any of the embodiments disclosed above, with appropriate modifications, the primary stitch 144 can be stitched through the skirt 123 in an in-and-out pattern. Similarly, with appropriate modifications, any type of non-penetrating stitch 182 disclosed above regarding the attachment of leaflet 132 to post 111 can be similarly adapted to attach the skirt 123 to post 111 in the same manner.

[0290] Figure 16 The view from inside the valve shows the coupling to Figure 15 A partial view of the outer skirt 124 of the strut 111 of the frame 106 of the valve 100 shown. For simplicity, from... Figure 16 The leaflet assembly 130 is omitted in the view shown. In the illustrated exemplary embodiment, the primary stitch 144 is stitched along the proximal end 129 of the skirt in an in-and-out pattern, for example, following its zigzag shape. In the case of the outer skirt 124, the primary stitch 144 may define a series of straight stitch portions, including an inner stitch portion 146 disposed on the inner surface 125 of the skirt and an outer skirt portion 148 disposed on the outer surface 126 of the skirt. Then, a plurality of non-penetrating seam stitches 182 are looped around the support section 111 via the support wrapping section 184 and around the straight stitch portions of the primary stitch 144 (such as on and between the inner stitch portion 146 and the inner surface 125 of the skirt).

[0291] Although Figure 16 For example, the diagram along the support segments 111m, 111n, 111o, and 111p illustrates the connection with [the support structure]. Figures 12A-12D The specific embodiments of those similar non-penetrating stitches 182 described herein should be understood, however, to be possible with appropriate modifications by implementing the above-described combination. Figures 11A-14 Any stitching pattern and method described herein for stitching the skirt to the corresponding support section 111.

[0292] In some embodiments, the joint lock 174 is similarly used to attach a skirt portion 123 (such as an outer skirt portion 124) to a joint 116 disposed between support sections 111 to which the skirt portions are sewn together via non-penetrating stitch 182, for example, in the illustrated example, joint locks 174m, 174n, 174o, 174p, and 174q formed on the respective joints 116m, 116n, 116o, 116p, and 116q. With appropriate modifications, the construction and method of forming such a joint lock 174 are similar to the construction and method described above with respect to the attachment of leaflets 132 to joints 116.

[0293] In some embodiments, the skirt portion 123 (such as the outer skirt portion 124) is coupled to another joint portion 116 via a separate knot. This additional joint portion 116 is not necessarily located between the support sections 111 around which the non-penetrating seam stitch 182 extends. This additional knot is not necessarily a joint lock knot 172, but can be implemented as other knots known in the art, such as... Figure 16 The diagram illustrates the joints 166r, 166s, and 166t surrounding the corresponding joints 116r, 116s, and 116t.

[0294] Figure 17 Another valve 100, including an outer skirt 124, is shown, which may be similar to Figure 15 The valve and skirt, except that the distal end 128 of the skirt is not linear, but follows the shape of the strut segment 111 along the inflow portion 104 of the valve, which can be wavy or arcuate (e.g. Figure 17 (as shown), or it may be zigzag or shaped to follow an alternative path defined by the distal strut segment of the valve.

[0295] Figure 18 The coupling to the valve is shown from the valve-bottom-interior perspective. Figure 17 A partial view of the outer skirt 124 of the strut 111 of the frame 106 of the valve 100 shown. For simplicity, from... Figure 18 The leaflet component 130 is omitted in the view shown. In the illustrated exemplary embodiment, the primary seam 144 is stitched along the distal end 129 of the skirt in an in-and-out pattern, for example, following its wavy shape. This can be implemented in the same manner as described above, except for the primary seam 144 stitched along the proximal end 129 of the skirt.

[0296] Then, multiple non-penetrating seam stitches 182 are looped around the support section 111 (of the inlet portion 104) and around the straight stitch portion of the primary seam 144 (e.g., on and between the inner stitch portion 146 and the inner surface 125 of the skirt) via a series of support wrapping sections 184. Although in Figure 18 For example, the diagram along the support segments 111u and 111w illustrates the connection. Figures 12A-12D The specific embodiments of those similar non-penetrating suture stitches 182 described herein are as follows; however, it should be understood that, with appropriate modifications, the above-described combinations can be implemented. Figures 11A-14 Any stitching pattern and method described herein for stitching the skirt to the corresponding support section 111.

[0297] In some embodiments, the joint lock 174 is similarly used to attach the outer skirt 124 to the joint 116 along the inlet end 104, such as the joint locks 174r, 174s and 174t formed around the respective joints 116r, 116s and 116t in the illustrated example, which, with appropriate modifications, follow the same construction and method described above with respect to the attachment of the leaflet 132 to the joint 116.

[0298] In some embodiments, the skirt portion 123 (such as the outer skirt portion 124) is attached in the same manner and according to all the alternative embodiments described above via a non-penetrating seam stitch 182 to an additional support section 111 disposed between the proximal end 129 and the distal end 128 of the skirt portion. For example, one or more primary seams 144 may be implemented along the area of ​​the skirt portion aligned with the support section 111 disposed between the proximal end 129 and the distal end 128 of the skirt portion in an in-and-out pattern stitch (when the skirt portion is attached to the frame), according to any embodiment of suturing such primary seams 144 described above. Figures 11A to 14 A series of non-penetrating seam stitches 182, implemented in any of the described embodiments, can be used to attach the skirt to the corresponding support section 111, such as, for example... Figure 18 As shown, along the support segments 111r, 111s, 111t, and 111v.

[0299] In some embodiments, the skirt 123 (such as the outer skirt 124) is attached in the same manner and according to all the alternative embodiments described above via a joint locking 174 to an additional joint 116 disposed between the proximal end 129 and the distal end 128 of the skirt.

[0300] Some valves provide an inner skirt (not shown) positioned around the inner surface of the frame. Although through Figure 15 - Figure 18 The outer skirt 124 is illustrated to show various attachment configurations to the frame; however, it should be understood that, with appropriate modifications, the same embodiments described above regarding the attachment of the outer skirt can be implemented in a similar manner for attaching the inner skirt to the frame.

[0301] In some embodiments, the joint locking 174 may be used to attach the skirt 123 (including either the inner skirt or the outer skirt) along either the proximal end 129 or the distal end 128 of the skirt to the joint 116, 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 using the non-penetrating seam stitch 182 surrounding the support section 111.

[0302] For example, with appropriate modifications, in the same manner and following the above... Figures 10-11D A similar method described for attaching leaflet 132 to frame 106 can be used to sew the skirt along any of the proximal end 129, the distal end 128 of the skirt to the corresponding support section 111, and / or to the support section 111 located between the proximal end 129 and the distal end 128 of the skirt (when the skirt is attached to the frame) via a series of stitches 172 that can penetrate through the primary suture 144, wherein the joint lock 174 is formed around the joint 116 located between these support sections 111.

[0303] Other examples of the disclosed technology

[0304] In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that examples with more than one feature, obtained by combining one or more features of one or more other examples individually or in combination, are also other examples falling within the scope of the disclosure of this application.

[0305] Example 1. A prosthetic valve, comprising:

[0306] A frame movable between a radially compressed configuration and a radially extended configuration, wherein the frame includes a plurality of intersecting struts, and

[0307] The leaflet assembly, which is mounted within the frame and includes a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of oppositely oriented lugs separating the tip edge and the free edge;

[0308] Each tip portion is coupled to at least one support via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern at the penetration point, the secondary suture passing through the primary suture and surrounding at least one segment of the at least one support, wherein the secondary suture includes a plurality of self-tightening structures, and wherein each self-tightening structure includes at least one loop configured to contract around the support under tension.

[0309] Example 2. A prosthetic valve according to any of the examples in this document (especially Example 1), wherein the at least one ring of each self-tightening structure comprises two rings.

[0310] Example 3. A prosthetic valve according to any of the examples in this document (in particular any one of Example 1 or 2), wherein each self-tightening structure further includes a U-shaped segment extending partially between the at least one ring and the strut.

[0311] Example 4. A prosthetic valve according to any of the examples herein (particularly any one of Examples 1 to 3), wherein the leaflet includes an inner surface and an outer surface of the leaflet, and wherein the primary suture includes a plurality of inner suture portions disposed along the inner surface of the leaflet and a plurality of outer suture portions disposed along the outer surface of the leaflet, each inner suture portion and each outer suture portion being defined between a corresponding penetration point.

[0312] Example 5. A prosthetic valve according to any of the examples in this document (particularly Example 4), wherein the self-tightening structure is defined between two penetration points, the penetration points defining at least one outer trace portion therebetween.

[0313] Example 6. A prosthetic valve according to any of the examples in this document (particularly any one of Example 4 or 5), wherein the secondary suture further includes a plurality of suture pull portions extending above the inner surface of the leaflet.

[0314] Example 7. A prosthetic valve according to any of the examples in this document (especially Example 6), wherein at least one of the suture pulling portions spans more than one inner or outer suture portion.

[0315] Example 8. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 6 or 7), wherein the suture pull portion presses against a portion of the at least one primary suture.

[0316] Example 9. A prosthetic valve according to any of the examples in this document (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.

[0317] Example 10. A prosthetic valve according to any of the examples in this article (especially Example 9), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0318] Example 11. A prosthetic valve according to any example in this article (especially Example 9), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0319] Example 12. A prosthetic valve according to any of the examples in this article (especially Example 9), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0320] Example 13. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1 to 12), wherein the tip portion of each leaflet includes a series of pre-formed holes.

[0321] Example 14. A prosthetic valve according to any of the examples in this document (particularly Example 13), wherein the opening is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0322] Example 15. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 13 or 14), wherein the holes are spaced equally apart from each other.

[0323] Example 16. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 13 to 15), wherein the diameter of the hole is equal to or smaller than the diameter of the primary suture.

[0324] Example 17. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 13 to 15), wherein the diameter of the orifice is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0325] Example 18. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1 to 17), wherein the secondary suture passes through all consecutive penetration points.

[0326] Example 19. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1 to 18), wherein the at least one primary suture comprises two primary sutures passing through the same penetration point in opposite directions with an in-out pattern.

[0327] Example 20. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 13 to 15), wherein the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0328] Example 21. A prosthetic valve according to any example in this document (particularly Example 20), wherein the diameter of the orifice is equal to or less than the combined diameter of the two primary sutures and the secondary sutures.

[0329] Example 22. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1 to 21), wherein the at least one primary suture follows the curvature of the at least one tip edge.

[0330] Example 23. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1 to 22), wherein the primary suture comprises a multifilament suture.

[0331] Example 24. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 1-23), wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0332] Example 25. A prosthetic valve according to any of the examples herein (in particular any one of Examples 1 to 24), wherein there is no fabric strip and / or fabric between the apical portion of the leaflets and the struts to which they are attached.

[0333] Example 26. A method for assembling a prosthetic valve, the method comprising the following steps:

[0334] Pass the primary suture through the tip portion of the leaflet in an in-and-out pattern;

[0335] At least one strut of a frame having the tip portion of the primary suture passing through it approaching the prosthetic valve; and

[0336] Secondary sutures are sutured through the primary sutures and around the at least one strut in a manner that forms multiple self-tightening structures, wherein each self-tightening structure is formed to include at least one loop configured to contract around the strut under tension.

[0337] Example 27. The method according to any example in this document (particularly Example 26), wherein the step of suturing the secondary suture includes passing the secondary suture radially outward through the primary suture at the penetration point, thereby forming the at least one loop around the at least one pillar.

[0338] Example 28. The method according to any example in this document (particularly Example 27), wherein the step of suturing the secondary suture includes looping the secondary suture around the at least one post again after forming the first loop, thereby forming two loops for each self-tightening structure.

[0339] Example 29. The method according to any of the examples in this document (in particular any one of Examples 26-28), wherein the step of suturing the secondary suture includes passing the secondary suture under the at least one loop and between the at least one loop and the at least one strut to form a U-shaped segment.

[0340] Example 30. According to any of the examples in this document (particularly the prosthetic valve of any of Examples 26 to 29), the method further includes the steps of extending the secondary suture over the inner surface of the leaflet and then passing the secondary suture through the primary suture again in a radially outward direction, thereby forming at least one suture pull portion extending over the inner surface of the leaflet.

[0341] Example 31. A prosthetic valve according to any of the examples herein (particularly any one of Examples 26 to 30), wherein the tip portion of each leaflet includes a series of pre-formed holes, and wherein the step of passing the primary suture includes passing the primary suture through the series of pre-formed holes in an in-out pattern.

[0342] Example 32. A prosthetic valve, comprising:

[0343] A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints, and

[0344] The leaflet assembly, which is mounted within the frame and includes a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of oppositely oriented lugs separating the tip edge and the free edge;

[0345] Each joint is defined between: two opposing axial sides, the two opposing axial sides including a proximal side of the joint and a distal side of the joint; two opposing radial sides, the two opposing radial sides including an inner side of the joint and an outer side of the joint; and two opposing lateral sides, the two opposing lateral sides including a first lateral side of the joint and a second lateral side of the joint.

[0346] Each tip portion is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern at the penetration point, the secondary suture passing through the primary suture and wrapping around the support segment with a series of suture stitches spaced apart from each other along the length of the support segment.

[0347] The tip portion is further coupled to at least one joint at the end of the support section via a joint lock knot formed by the secondary suture, and the joint lock knot is configured to maintain tension on the plurality of suture stitches wrapped around the corresponding support section leading to the first transverse section of the joint.

[0348] Example 33. A prosthetic valve according to any example in this document (particularly Example 32), wherein each junctional locking includes:

[0349] A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint.

[0350] A first ring extends from the transition section and around a support section extending from the second lateral side of the joint; and

[0351] The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

[0352] Example 34. A prosthetic valve according to any example herein (particularly Example 33), wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0353] Example 35. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 33 or 34), wherein both the first ring and the second ring are tightly tensioned around the junction.

[0354] Example 36. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 32 to 35), wherein the plurality of respective suture stitches wrapped around a single strut segment are inclined suture stitches oriented in the same direction along the length of the corresponding strut segment.

[0355] Example 37. A prosthetic valve according to any example herein (particularly Example 36), wherein the tip portion is sutured to at least two strut segments extending from two transverse sides of a selected joint via a plurality of suture stitches wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of suture stitches around one of the strut segments are inclined in a direction opposite to that of the plurality of suture stitches wrapped around the other strut segment.

[0356] Example 38. A prosthetic valve according to any of the examples in this document (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.

[0357] Example 39. A prosthetic valve according to any of the examples in this article (especially Example 38), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0358] Example 40. A prosthetic valve according to any example in this article (especially Example 38), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0359] Example 41. A prosthetic valve according to any example in this article (especially Example 38), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0360] Example 42. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 32 to 41), wherein the tip portion of each leaflet includes a series of pre-formed holes.

[0361] Example 43. A prosthetic valve according to any of the examples in this document (particularly Example 42), wherein the opening is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0362] Example 44. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 42 or 43), wherein the holes are spaced equally apart from each other.

[0363] Example 45. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 42 to 44), wherein the diameter of the hole is equal to or smaller than the diameter of the primary suture.

[0364] Example 46. A prosthetic valve according to any of the examples herein (particularly any one of Examples 42 to 44), wherein the diameter of the orifice is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0365] Example 47. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 32 to 46), wherein the at least one primary suture comprises two primary sutures passing through the same penetration point in opposite directions with an in-out pattern.

[0366] Example 48. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 42 to 44), wherein the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0367] Example 49. A prosthetic valve according to any example in this document (particularly Example 48), wherein the diameter of the orifice is equal to or less than the combined diameter of the two primary sutures and the secondary sutures.

[0368] Example 50. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 32 to 49), wherein the at least one primary suture follows the curvature of the at least one tip edge.

[0369] Example 51. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 32 to 50), wherein the primary suture comprises a multifilament suture.

[0370] Example 52. A prosthetic valve according to any of the examples in this document (in particular any of Examples 32-51), wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0371] Example 53. A prosthetic valve according to any of the examples herein (particularly any one of Examples 32 to 52), wherein the prosthetic valve has no fabric strips and / or fabric between the tip portion of the leaflet and the strut segment and the junction to which they are attached.

[0372] Example 54. A method for assembling a prosthetic valve, the method comprising the following steps:

[0373] Pass the primary suture through the tip portion of the leaflet in an in-and-out pattern;

[0374] At least one strut segment of the frame having the tip portion of the primary suture passing through it approaching the prosthetic valve;

[0375] Secondary sutures are sutured through the primary sutures and around the at least one support segment in a manner that forms multiple suture stitches wrapped around the support segment until a final suture stitch is formed; and

[0376] A joint lock is formed extending from the final seam stitch around the corresponding end of the corresponding support section, wherein the joint lock is configured to maintain tension on the plurality of seam stitches wrapped around the support section and leading to the first transverse section of the joint.

[0377] Example 55. The method according to any example in this document (particularly Example 54), wherein the step of forming the joint lock includes extending the secondary suture from the final suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0378] Example 56. The method according to any example in this document (particularly Example 55), wherein the step of forming the joint lock further comprises extending the secondary suture from the transition section around a support section extending from the second transverse side of the joint, thereby forming a first loop of the joint lock.

[0379] Example 57. The method according to any example in this document (particularly Example 56), wherein the step of forming the joint lock further comprises extending the secondary suture from the first ring between the transition section and the joint, folding the secondary suture back over itself and passing it through the first ring to form a second ring of the joint lock.

[0380] Example 58. The method according to any example in this document (particularly Example 57), wherein the step of forming the joint lock further comprises forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0381] Example 59. The method according to any example in this document (in particular any one of Examples 55-58), wherein forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0382] Example 60. The method according to any example in this document (in particular any one of Examples 54 to 59), wherein forming the plurality of seam stitches around any single post segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding post segment.

[0383] Example 61. The method according to any example herein (particularly Example 60), wherein suturing the secondary suture around the at least one support segment comprises suturing around at least two support segments separated from each other by a common joint, such that all suture stitches around one of the support segments are formed as inclined suture stitches oriented in one direction, while all suture stitches around the other support segment are formed as inclined suture stitches oriented in a second direction opposite to the first direction.

[0384] Example 62. The method according to any of the examples herein (in particular any one of Examples 54 to 61), wherein the tip portion of each leaflet includes a series of pre-formed holes, and wherein the step of passing the primary suture includes passing the primary suture through the series of pre-formed holes in an in-and-out pattern.

[0385] Example 63. A prosthetic valve, comprising:

[0386] A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints, and

[0387] The leaflet assembly, which is mounted within the frame and includes a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of oppositely oriented lugs separating the tip edge and the free edge;

[0388] Each tip portion is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern, the secondary sutures forming a series of non-penetrating sutures spaced apart from each other along the length of the support segment, each non-penetrating suture including a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the leaflet.

[0389] Example 64. A prosthetic valve according to any example in this document (particularly Example 63), wherein the primary suture defines a series of straight stitch portions, and wherein each primary suture wrapping segment loops around the corresponding straight stitch portion and extends between the straight stitch portion and the rounded tip portion.

[0390] Example 65. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63 or 64), wherein the secondary suture does not penetrate through the leaflet.

[0391] Example 66. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63 to 65), wherein the secondary suture does not penetrate through the primary suture.

[0392] Example 67. A prosthetic valve according to any example herein (particularly any one of Examples 63 to 66), wherein each joint is defined between: two opposing axial sides, the two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing lateral sides, the two opposing lateral sides comprising a first lateral joint side and a second lateral joint side; wherein the tip portion is further coupled to at least one joint at the end of the strut segment via a joint lock knot formed by the secondary suture, and wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating sutures wound around the corresponding strut segment leading to the first lateral joint segment.

[0393] Example 68. A prosthetic valve according to any example in this document (particularly Example 67), wherein each junctional locking includes:

[0394] A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint.

[0395] A first ring extends from the transition section and around a support section extending from the second lateral side of the joint; and

[0396] The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

[0397] Example 69. A prosthetic valve according to any example herein (particularly Example 68), wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint, and from one lateral side of the joint to the opposite lateral side of the joint.

[0398] Example 70. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 68 or 69), wherein both the first ring and the second ring are tightly tensioned around the junction.

[0399] Example 71. A prosthetic valve according to any of the examples in this document (in particular any of Examples 67 to 70), wherein the plurality of non-penetrating sutures wrapped around a single strut segment are inclined non-penetrating sutures oriented in the same direction along the length of the corresponding strut segment.

[0400] Example 72. A prosthetic valve according to any example herein (particularly Example 71), wherein the tip portion is sutured to at least two strut segments extending from two transverse sides of a selected joint via a plurality of non-penetrating sutures wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of non-penetrating sutures around one of the strut segments are inclined in a direction opposite to that of the plurality of non-penetrating sutures wrapped around the other strut segment.

[0401] Example 73. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63 to 72), wherein the at least one primary suture comprises two primary sutures passing in opposite directions with an in-out pattern.

[0402] Example 74. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63 to 73), wherein the at least one primary suture follows the curvature of the at least one tip edge.

[0403] Example 75. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63 to 74), wherein the primary suture comprises a multifilament suture.

[0404] Example 76. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 63-75), wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0405] Example 77. A prosthetic valve according to any of the examples herein (in particular any one of Examples 63 to 76), wherein the prosthetic valve has no fabric strips and / or fabric between the apical portion of the leaflets and the strut segment to which they are attached.

[0406] Example 78. A method for assembling a prosthetic valve, the method comprising the following steps:

[0407] Pass the primary suture through the tip portion of the leaflet in an in-and-out pattern;

[0408] At least one strut segment of the frame having the tip portion of the primary suture passing through it approaching the prosthetic valve; and

[0409] The secondary sutures are looped around the at least one support segment and around the primary suture in a manner that forms multiple non-penetrating suture stitches around the support segment until a final non-penetrating suture stitch. Each non-penetrating suture stitch includes a support winding segment looping around the support segment and a primary suture winding segment extending therefrom, the primary suture winding segment passing between the primary suture and the leaflet and looping around the primary suture.

[0410] Example 79. The method according to any example in this document (especially Example 78), wherein forming each non-penetrating suture includes forming the support wrapping section by extending the secondary suture across one radial side of the support section, folding it over the axial side of the support section, and extending it rearward across the opposite radial side of the support section.

[0411] Example 80. The method according to any example (particularly Example 79) herein, wherein forming each non-penetrating suture stitch further comprises forming the primary suture wrapping section by: passing the secondary suture between the straight stitch portion of the primary suture and the tip portion of the leaflet, and folding it over the straight stitch portion.

[0412] Example 81. The method according to any example in this document (particularly Example 79), wherein forming each non-penetrating suture stitch further comprises forming the primary suture wrapping segment by: passing the secondary suture over the straight stitch portion of the primary suture, and returning it over the straight stitch portion and looping it between the straight stitch portion and the tip portion of the leaflet.

[0413] Example 82. The method according to any example in this document (in particular any one of Examples 80 or 81), wherein the straight stitch portion is the outer stitch portion of the primary suture.

[0414] Example 83. According to any of the examples in this document (in particular any of Examples 78 to 82), the method further includes the step of forming a joint lock knot extending from the final non-penetrating stitch around the corresponding end of the corresponding support section, wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating stitches wrapped around the support section and leading to the first transverse section of the joint.

[0415] Example 84. The method according to any example herein (particularly Example 83), wherein the step of forming the joint lock includes extending the secondary suture from the final non-penetrating suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0416] Example 85. The method according to any example herein (particularly Example 84), wherein the step of forming the joint lock further comprises extending the secondary suture from the transition section around a support section extending from the second transverse side of the joint, thereby forming a first loop of the joint lock.

[0417] Example 86. The method according to any example herein (particularly Example 85), wherein the step of forming the joint lock further comprises extending the secondary suture from the first ring between the transition section and the joint, folding the secondary suture back over itself and passing it through the first ring to form a second ring of the joint lock.

[0418] Example 87. The method according to any example in this document (particularly Example 86), wherein the step of forming the joint lock further comprises forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0419] Example 88. The method according to any example in this document (in particular any one of Examples 84-87), wherein forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0420] Example 89. The method according to any example in this document (in particular any one of Examples 83 to 88), wherein forming the plurality of seam stitches around any single post segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding post segment.

[0421] Example 90. The method according to any example herein (particularly Example 89), wherein forming the plurality of seam stitches around the at least one support segment comprises forming a plurality of seam stitches around at least two support segments separated from each other by a common joint, such that all seam stitches around one of the support segments are formed as inclined seam stitches oriented in one direction, while all seam stitches around the other support segment are formed as inclined seam stitches oriented in a second direction opposite to the first direction.

[0422] Example 91. A prosthetic valve, comprising:

[0423] A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints;

[0424] A leaflet assembly, the leaflet assembly being mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; and

[0425] A skirt portion, the skirt portion being disposed around the frame, the skirt portion including a proximal end and a distal end;

[0426] Each joint is defined between: two opposing axial sides, the two opposing axial sides including a proximal side of the joint and a distal side of the joint; two opposing radial sides, the two opposing radial sides including an inner side of the joint and an outer side of the joint; and two opposing lateral sides, the two opposing lateral sides including a first lateral side of the joint and a second lateral side of the joint.

[0427] The proximal end of the skirt is coupled to at least one support segment via at least one primary suture and a secondary suture, wherein the at least one primary suture passes through it in an in-out pattern at the penetration point, and the secondary suture passes through the primary suture and wraps around the support segment with a series of seam stitches spaced apart from each other along the length of the support segment.

[0428] The proximal end of the skirt is further coupled to at least one joint at the end of the support section via a joint lock formed by the secondary stitches, and the joint lock is configured to maintain tension on the plurality of seam stitches wrapped around the corresponding support section leading to the first transverse section of the joint.

[0429] Example 92. A prosthetic valve according to any of the examples in this document (especially Example 91), wherein the proximal end of the skirt follows a zigzag pattern.

[0430] Example 93. A prosthetic valve according to any of the examples in this document (especially Example 92), wherein at least one primary suture follows a zigzag pattern at the proximal end of the skirt.

[0431] Example 94. A prosthetic valve according to any of the examples herein (particularly any one of Examples 91 to 93), wherein each junctional locking comprises:

[0432] A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint.

[0433] A first ring extends from the transition section and around a support section extending from the second lateral side of the joint; and

[0434] The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

[0435] Example 95. A prosthetic valve according to any example herein (particularly Example 94), wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0436] Example 96. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 94 or 95), wherein both the first ring and the second ring are tightly tensioned around the junction.

[0437] Example 97. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 91 to 96), wherein the respective plurality of suture stitches wrapped around a single strut segment are inclined suture stitches oriented in the same direction along the length of the corresponding strut segment.

[0438] Example 98. A prosthetic valve according to any example herein (particularly Example 97), wherein the proximal end of the skirt is sutured to at least two strut segments extending from two transverse sides of a selected joint via a plurality of suture stitches wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of suture stitches around one of the strut segments are inclined in a direction opposite to that of the plurality of suture stitches wrapped around the other strut segment.

[0439] Example 99. A prosthetic valve according to any example herein (particularly any one of Examples 91 to 98), wherein the distal end of the skirt is coupled at the inflow portion of the valve to at least one strut segment via at least one additional primary suture and additional secondary sutures, the at least one additional primary suture passing through it in an in-out pattern at the penetration point, the additional secondary sutures passing through the primary sutures and wrapping around the strut segment at the inflow portion with a series of suture stitches spaced apart from each other along the length of the strut segment, and wherein the distal end of the skirt is further coupled via an additional joint lock to at least one joint at the end of the strut segment at the inflow portion.

[0440] Example 100. A prosthetic valve according to any of the examples in this document (particularly Example 99), wherein the additional primary sutures follow the shape of the strut segment disposed around the inflow portion.

[0441] Example 101. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 91-100), wherein the diameter of the secondary suture is smaller than the diameter of the primary suture.

[0442] Example 102. A prosthetic valve according to any example in this document (especially Example 101), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.8.

[0443] Example 103. A prosthetic valve according to any example in this document (especially Example 101), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.5.

[0444] Example 104. A prosthetic valve according to any example in this document (especially Example 101), wherein the ratio of the secondary to the primary suture diameter is equal to or less than 0.3.

[0445] Example 105. A prosthetic valve according to any of the examples herein (in particular any one of Examples 91 to 104), wherein the proximal end of the skirt includes a series of pre-formed holes.

[0446] Example 106. A prosthetic valve according to any of the examples in this document (particularly Example 105), wherein the opening is sized to receive the at least one primary suture, thereby serving as the penetration point.

[0447] Example 107. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 105 or 106), wherein the holes are spaced equally apart from each other.

[0448] Example 108. A prosthetic valve according to any of the examples herein (in particular any one of Examples 105 to 107), wherein the diameter of the orifice is equal to or smaller than the diameter of the primary suture.

[0449] Example 109. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 105 to 107), wherein the diameter of the orifice is equal to or less than the combined diameter of the primary suture and the secondary suture.

[0450] Example 110. A prosthetic valve according to any of the examples herein (in particular any one of Examples 91 to 109), wherein the at least one primary suture comprises two primary sutures passing through the same penetration point in opposite directions with an in-out pattern.

[0451] Example 111. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 105 to 107), wherein the diameter of the hole is equal to or less than the diameter of the two primary sutures.

[0452] Example 112. A prosthetic valve according to any example in this document (particularly Example 111), wherein the diameter of the orifice is equal to or less than the combined diameter of the two primary sutures and the secondary sutures.

[0453] Example 113. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 91-112), wherein the primary suture comprises a multifilament suture.

[0454] Example 114. A prosthetic valve according to any of the examples in this document (in particular any of Examples 91-113), wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0455] Example 115. A prosthetic valve according to any of the examples herein (in particular any one of Examples 91 to 114), wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0456] Example 116. A method for assembling a prosthetic valve, the method comprising the following steps:

[0457] Make the primary seam pass through the near end of the skirt to enter and exit the pattern;

[0458] At least one strut segment of the frame having the proximal end of the skirt having the primary suture passing through it approaching the prosthetic valve;

[0459] Secondary sutures are sutured through the primary sutures and around the at least one support segment in a manner that forms multiple suture stitches wrapped around the support segment until a final suture stitch is formed; and

[0460] A joint lock is formed extending from the final seam stitch around the corresponding end of the corresponding support section, wherein the joint lock is configured to maintain tension on the plurality of seam stitches wrapped around the support section and leading to the first transverse section of the joint.

[0461] Example 117. The method according to any example herein (particularly Example 116), wherein the step of forming the joint lock includes extending the secondary suture from the final suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0462] Example 118. The method according to any example in this document (particularly Example 117), wherein the step of forming the joint lock further comprises extending the secondary suture from the transition section around a support section extending from the second transverse side of the joint, thereby forming a first loop of the joint lock.

[0463] Example 119. The method according to any example herein (particularly Example 118), wherein the step of forming the joint lock further comprises extending the secondary suture from the first ring between the transition section and the joint, folding the secondary suture back over itself and passing it through the first ring to form a second ring of the joint lock.

[0464] Example 120. The method according to any example in this document (particularly Example 119), wherein the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0465] Example 121. The method according to any example in this document (in particular any one of Examples 117-120), wherein forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0466] Example 122. The method according to any example in this document (in particular any one of Examples 116 to 121), wherein forming the plurality of seam stitches around any single support segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding support segment.

[0467] Example 123. The method according to any example herein (particularly Example 122), wherein suturing the secondary suture around the at least one support segment comprises suturing around at least two support segments separated from each other by a common joint, such that all suture stitches around one of the support segments are formed as inclined suture stitches oriented in one direction, while all suture stitches around the other support segment are formed as inclined suture stitches oriented in a second direction opposite to the first direction.

[0468] Example 124. The method according to any of the examples herein (in particular any one of Examples 116 to 123), wherein the proximal end of the skirt includes a series of pre-formed holes, and wherein the step of passing through the primary suture includes passing the primary suture through the series of pre-formed holes in an in-and-out pattern.

[0469] Example 125. The method according to any of the examples in this document (in particular any one of Examples 116 to 124), wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0470] Example 126. A prosthetic valve, comprising:

[0471] A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints;

[0472] A leaflet assembly, the leaflet assembly being mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; and

[0473] A skirt portion, the skirt portion being disposed around the frame, the skirt portion including a proximal end and a distal end.

[0474] The proximal end of the skirt is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern, the secondary suture forming a series of non-penetrating sutures spaced apart from each other along the length of the support segment, each non-penetrating suture including a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the leaflet.

[0475] Example 127. A prosthetic valve according to any of the examples in this document (especially Example 126), wherein the proximal end of the skirt follows a zigzag pattern.

[0476] Example 128. A prosthetic valve according to any of the examples in this document (particularly Example 127), wherein the at least one primary suture traces a zigzag pattern at the proximal end of the skirt.

[0477] Example 129. A prosthetic valve according to any of the examples herein (particularly any one of Examples 126 to 128), wherein the primary suture defines a series of straight stitch portions, and wherein each primary suture wrapping segment loops around the corresponding straight stitch portion and extends between the straight stitch portion and the proximal end of the skirt.

[0478] Example 130. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 126 to 129), wherein the secondary suture does not penetrate through the skirt.

[0479] Example 131. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 126 to 130), wherein the secondary suture does not penetrate through the primary suture.

[0480] Example 132. A prosthetic valve according to any example herein (particularly any one of Examples 126 to 131), wherein each joint is defined between: two opposing axial sides, the two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing transverse sides, the two opposing transverse sides comprising a first transverse joint side and a second transverse joint side; wherein the proximal end of the skirt is further coupled to at least one joint at the end of the strut segment via a joint lock knot formed by the secondary sutures, and wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating sutures wound around the corresponding strut segment leading to the first transverse joint segment.

[0481] Example 133. A prosthetic valve according to any example in this document (particularly Example 132), wherein each junctional locking includes:

[0482] A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint.

[0483] A first ring extends from the transition section and around a support section extending from the second lateral side of the joint; and

[0484] The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

[0485] Example 134. A prosthetic valve according to any example herein (particularly Example 133), wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0486] Example 135. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 133 or 134), wherein both the first ring and the second ring are tightly tensioned around the junction.

[0487] Example 136. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 132 to 135), wherein the plurality of non-penetrating sutures wrapped around a single strut segment are inclined non-penetrating sutures oriented in the same direction along the length of the corresponding strut segment.

[0488] Example 137. A prosthetic valve according to any example herein (particularly Example 136), wherein the proximal end of the skirt is sutured to at least two strut segments extending from two transverse sides of a selected joint via a plurality of non-penetrating suture stitches wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of non-penetrating suture stitches around one of the strut segments are inclined in a direction opposite to that of the plurality of non-penetrating suture stitches wrapped around the other strut segment.

[0489] Example 138. A prosthetic valve according to any of the examples herein (particularly any one of Examples 126 to 137), wherein the distal end of the skirt is coupled at the inflow portion of the valve to at least one strut segment via at least one additional primary suture and additional secondary sutures, the at least one additional primary suture passing through it in an in-out pattern at the penetration point, the additional secondary sutures passing through the primary sutures and wrapping around the strut segment at the inflow portion with a series of suture stitches spaced apart from each other along the length of the strut segment, and wherein the distal end of the skirt is coupled via an additional joint lock to at least one joint at the end of the strut segment at the inflow portion.

[0490] Example 139. A prosthetic valve according to any of the examples herein (particularly Example 138), wherein the additional primary sutures follow the shape of the strut segment disposed around the inflow portion.

[0491] Example 140. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 126 to 139), wherein the primary suture comprises a multifilament suture.

[0492] Example 141. A prosthetic valve according to any of the examples in this document (in particular any of Examples 126-140), wherein the secondary suture comprises ultra-high molecular weight polyethylene.

[0493] Example 142. A prosthetic valve according to any of the examples herein (in particular any one of Examples 126 to 141), wherein the skirt is an outer skirt disposed around the outer surface of the frame.

[0494] Example 143. A method for assembling a prosthetic valve, the method comprising the following steps:

[0495] Make the primary seam pass through the near end of the skirt to enter and exit the pattern;

[0496] At least one strut segment of the frame having the proximal end of the skirt having the primary suture passing through it adjacent to the prosthetic valve; and

[0497] The secondary sutures are looped around the at least one support segment and around the primary suture in such a manner that multiple non-penetrating sutures are formed around the support segment until a final non-penetrating suture is formed. Each non-penetrating suture includes a support wrapping segment that loops around the support segment and a primary suture wrapping segment extending therefrom, the primary suture wrapping segment passing around the primary suture between the primary suture and the proximal end of the skirt.

[0498] Example 144. The method according to any example in this document (particularly Example 143), wherein forming each non-penetrating suture includes forming the support wrapping section by extending the secondary suture across one radial side of the support section, folding it over the axial side of the support section, and extending it rearward across the opposite radial side of the support section.

[0499] Example 145. The method according to any example in this document (particularly Example 144), wherein forming each non-penetrating suture stitch further comprises forming the primary suture wrapping section by passing the secondary suture between the straight stitch portion of the primary suture and the proximal end of the skirt, and folding it over the straight stitch portion.

[0500] Example 146. The method according to any example herein (particularly Example 144), wherein forming each non-penetrating suture further comprises forming the primary suture wrapping segment by: passing the secondary suture over the straight stitch portion of the primary suture, and returning it over the straight stitch portion and looping it between the straight stitch portion and the proximal end of the skirt.

[0501] Example 147. The method according to any of the examples in this document (in particular any one of Examples 145 or 146), wherein the skirt portion is an outer skirt portion and the straight stitch portion is an inner stitch portion of the primary seam.

[0502] Example 148. The method according to any of the examples herein (in particular any of Examples 143 to 147) further includes the step of forming a joint lock knot extending from the final non-penetrating stitch around the corresponding end of the corresponding support section, wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating stitches wrapped around the support section toward the first transverse section of the joint.

[0503] Example 149. The method according to any example herein (particularly Example 148), wherein the step of forming the joint lock includes extending the secondary suture from the final non-penetrating suture stitch disposed on the first transverse side of the joint in a direction toward the second transverse side of the joint on one axial side of the joint, thereby forming a transition section of the joint lock.

[0504] Example 150. The method according to any example herein (particularly Example 149), wherein the step of forming the joint lock further comprises extending the secondary suture from the transition section around a support section extending from the second transverse side of the joint, thereby forming a first loop of the joint lock.

[0505] Example 151. The method according to any example herein (particularly Example 150), wherein the step of forming the joint lock further comprises extending the 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 to form a second loop of the joint lock.

[0506] Example 152. The method according to any example in this document (particularly Example 151), wherein the step of forming the joint lock further includes forcibly pulling the tail of the second ring to tighten both the first ring and the second ring around the joint.

[0507] Example 153. The method according to any example in this document (in particular any one of Examples 149-152), wherein forming the transition section includes extending the secondary suture in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

[0508] Example 154. The method according to any example in this document (in particular any one of Examples 148 to 153), wherein forming the plurality of seam stitches around any single post segment includes forming a plurality of inclined seam stitches oriented in the same direction around the length of the corresponding post segment.

[0509] Example 155. The method according to any example herein (particularly Example 154), wherein forming the plurality of seam stitches around the at least one support segment comprises forming a plurality of seam stitches around at least two support segments separated from each other by a common joint, such that all seam stitches around one of the support segments are formed as inclined seam stitches oriented in one direction, while all seam stitches around the other support segment are formed as inclined seam stitches oriented in a second direction opposite to the first direction.

[0510] It should be appreciated that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination, or are adapted to be provided in any other described embodiment of the invention. Features described in the context of an embodiment are not considered essential features of that embodiment unless expressly stated otherwise.

[0511] Given that the principles of this disclosure can be applied to many possible embodiments therein, it should be understood that the illustrated embodiments are merely preferred examples and should not be considered as limiting the scope. Rather, the scope is defined by the appended claims. Therefore, we claim protection for all contents falling within the scope and spirit of these claims.

Claims

1. A prosthetic valve, comprising: A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints, and The leaflet assembly, which is mounted within the frame and includes a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet includes a rounded tip portion defining a tip edge, a free edge opposite to the tip edge, and a pair of oppositely oriented lugs separating the tip edge and the free edge; Each tip portion is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern, the secondary sutures forming a series of non-penetrating sutures spaced apart from each other along the length of the support segment, each non-penetrating suture including a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the leaflet, wherein the secondary sutures do not penetrate through the leaflet.

2. The prosthetic valve of claim 1, wherein the primary suture defines a series of straight stitch portions, and wherein each primary suture winding segment loops around a corresponding straight stitch portion and extends between the straight stitch portion and the rounded tip portion.

3. The prosthetic valve according to any one of claims 1 to 2, wherein the secondary suture does not penetrate through the primary suture.

4. The prosthetic valve according to any one of claims 1 to 3, wherein each joint is defined between: two opposing axial sides, the two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing lateral sides, the two opposing lateral sides comprising a first lateral joint side and a second lateral joint side; wherein the tip portion is further coupled to at least one joint at the end of the strut segment via a joint lock knot formed by the secondary sutures, and wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating sutures wound around the corresponding strut segment leading to the first lateral joint segment.

5. The prosthetic valve of claim 4, wherein each junction locking comprises: A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint. The first ring extends from the transition section and around the support section extending from the second lateral side of the joint; as well as The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

6. The prosthetic valve of claim 5, wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

7. The prosthetic valve according to claim 5 or 6, wherein both the first ring and the second ring are tightly tensioned around the junction.

8. The prosthetic valve according to any one of claims 4 to 7, wherein the plurality of non-penetrating sutures wrapped around a single strut segment are inclined non-penetrating sutures oriented in the same direction along the length of the corresponding strut segment.

9. The prosthetic valve of claim 8, wherein the tip portion is sutured to at least two strut segments extending from two transverse sides of the selected joint via a plurality of non-penetrating sutures wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of non-penetrating sutures around one of the strut segments are inclined in a direction opposite to that of the plurality of non-penetrating sutures wrapped around the other strut segment.

10. The prosthetic valve according to any one of claims 1 to 9, wherein the prosthetic valve has no fabric strip between the tip portion of the leaflets and the strut segment to which they are attached.

11. The prosthetic valve according to any one of claims 1 to 9, wherein the prosthetic valve has no fabric between the tip portion of the leaflets and the strut segment to which they are attached.

12. A prosthetic valve, comprising: A frame movable between a radially compressed structure and a radially extended structure, wherein the frame includes a plurality of strut segments intersecting at joints; The leaflet assembly is mounted within the frame and includes a plurality of leaflets configured to regulate flow through the prosthetic valve; as well as A skirt portion, the skirt portion being disposed around the frame, the skirt portion including a proximal end and a distal end. The proximal end of the skirt is coupled to at least one support segment via at least one primary suture and a secondary suture, the at least one primary suture passing through it in an in-out pattern, the secondary suture forming a series of non-penetrating seam stitches spaced apart from each other along the length of the support segment, each non-penetrating seam stitch including a support wrapping segment looping around the support segment and a primary suture wrapping segment extending therefrom, looping around the primary suture, and passing between the primary suture and the skirt, wherein the secondary sutures do not penetrate through the skirt.

13. The prosthetic valve of claim 12, wherein the primary suture defines a series of straight stitch portions, and wherein each primary suture wrapping segment loops around the corresponding straight stitch portion and extends between the straight stitch portion and the proximal end of the skirt.

14. The prosthetic valve according to any one of claims 12 to 13, wherein the secondary suture does not penetrate through the primary suture.

15. The prosthetic valve according to any one of claims 12 to 14, wherein each joint is defined between: two opposing axial sides, the two opposing axial sides comprising a proximal joint side and a distal joint side; two opposing radial sides, the two opposing radial sides comprising an inner joint side and an outer joint side; and two opposing lateral sides, the two opposing lateral sides comprising a first lateral joint side and a second lateral joint side; wherein the proximal end of the skirt is further coupled to at least one joint at the end of the strut segment via a joint lock knot formed by the secondary sutures, and wherein the joint lock knot is configured to maintain tension on the plurality of non-penetrating sutures wound around the corresponding strut segment leading to the first lateral joint segment.

16. The prosthetic valve of claim 15, wherein each junction locking comprises: A transition section extends over one axial side of the joint in a direction from the first lateral side of the joint to the second lateral side of the joint. The first ring extends from the transition section and around the support section extending from the second lateral side of the joint; as well as The second ring extends from the first ring between the transition section and the joint, and is folded over itself to extend through the first ring.

17. The prosthetic valve of claim 16, wherein the transition segment extends in a diagonal direction from one radial side of the joint toward the opposite radial side of the joint and from one lateral side of the joint to the opposite lateral side of the joint.

18. The prosthetic valve according to claim 16 or 17, wherein both the first ring and the second ring are tightly tensioned around the junction.

19. The prosthetic valve according to any one of claims 15 to 18, wherein the plurality of non-penetrating sutures wrapped around a single strut segment are inclined non-penetrating sutures oriented in the same direction along the length of the corresponding strut segment.

20. The prosthetic valve of claim 19, wherein the proximal end of the skirt is sutured to at least two strut segments extending from two transverse sides of the selected joint via a plurality of non-penetrating suture stitches wrapped around each of the respective strut segments and a joint lock knot positioned therebetween around the joint, and wherein the plurality of non-penetrating suture stitches around one of the strut segments are inclined in a direction opposite to the direction of the plurality of non-penetrating suture stitches wrapped around the other strut segment.

Images