Prosthetic valve

Abstract

The invention relates to a prosthetic valve. A prosthetic valve includes an annular frame and a skirt. The frame is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The skirt has a fold around the inflow end of the frame so as to cover at least a portion of the outer surface of the frame and at least a portion of the inner surface of the frame. When the frame is in the radially expanded configuration, the outboard portion of the skirt closely conforms to the outer surface of the frame and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inflow end of the frame extends axially so as to at least partially fill the axially extending gap.

Description

[0001] This application is a divisional application. The application date of the original application is January 23, 2020, the application number is 2020800208003, and the name of the invention is “Prosthetic Valve”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 797,837, filed January 28, 2019, which is incorporated herein by reference. Technical Field

[0004] The present disclosure relates to embodiments of prosthetic valves for implantation in a body duct, such as a native heart valve annulus, and methods of implanting prosthetic valves. Background Art

[0005] The human heart may suffer from various valvular diseases. These valvular diseases can lead to significant cardiac dysfunction, and ultimately require replacement of the natural valve with an artificial valve. There are a variety of known artificial valves and a variety of known methods for implanting these artificial valves into the human body. Due to the shortcomings associated with traditional open heart surgery, percutaneous and minimally invasive surgical methods are attracting strong attention. In one technique, a prosthetic heart valve is configured to be implanted by catheterization with a much less invasive procedure. For example, the prosthetic heart valve can be mounted in a curled state at the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by expanding a balloon equipped with a prosthetic valve, or by deploying a prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size, or by other means. Despite recent advances in percutaneous valve technology, there is still a need for improved prosthetic valves and methods for delivering such valves.

[0006] Known prosthetic valves can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped on an implant delivery device in a radially compressed state during delivery, and then expanded to a radially expanded state after the prosthetic valve reaches the implantation site.

[0007] A prosthetic valve typically includes a frame in which the valve structure (e.g., leaflets) is mounted; an inner skirt that is secured to the inside of the frame; and optionally an outer skirt that is secured to the outside of the frame. The inner skirt can have several functions. For example, the inner skirt can be used as a sealing element to prevent (or reduce) paravalvular leakage and anchor the leaflets to the frame. The outer skirt can cooperate with the inner skirt to further reduce or avoid paravalvular leakage after the valve is implanted. The inner and outer skirts can be secured to the frame by sewing or suturing the fabric of the corresponding skirts to the frame.

[0008] Although various other synthetic or natural materials can be used, the inner skirt desirably includes a tough, tear-resistant material such as polyethylene terephthalate (PET). The skirt formed by traditional woven PET or similar fabrics is essentially inelastic and can therefore be difficult to stretch. The lack of skirt elasticity can pose a challenge to the curling of the prosthetic valve. For example, curling the prosthetic valve tends to reduce the diameter of the frame while stretching the frame in the axial direction. Since the skirt is usually sutured to the frame, the inelasticity of the skirt can limit the axial elongation of the frame. In some cases, curling can produce a large amount of stress on the fabric at the suture point, which may cause suture tearing, fabric tearing or frame deformation. Further, depending on how the skirt is sutured to the frame, the constraints of the skirt during curling can be localized so that some areas of the skirt can conform more closely to the frame than other areas. This uneven tightening can cause the skirt to be unexpectedly unevenly attached to the frame, and can further cause tearing of sutures and / or fabrics, or distortion of the frame. One possible solution to this problem is to size the skirt so that there is slack in the radial direction when the prosthetic valve is in a radially expanded state. This slack allows the prosthetic valve to elongate axially during curling without being limited or constrained by the skirt. However, the use of additional fabric can increase the radial profile of the prosthetic valve, which is detrimental to transcatheter valve implantation. In addition, loose fabric can protrude through the cells of the frame and contact the leaflets, resulting in undesirable wear of the leaflets. Therefore, it is desirable to improve the skirt of a prosthetic valve. Summary of the invention

[0009] Examples of prosthetic valves and related methods of implanting prosthetic valves are described herein. The prosthetic valves disclosed herein can be implanted in any natural valve of the heart (aortic valve, mitral valve, tricuspid valve and pulmonary valve). In some embodiments, the prosthetic valve can be delivered through the vascular system and implanted into the patient's heart by utilizing a delivery device.

[0010] Certain embodiments of the present disclosure relate to a prosthetic valve having an annular frame, a valve structure and an annular skirt. The annular frame can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration. The valve structure can be positioned within the frame and configured to allow blood to flow through the prosthetic valve in one direction and prevent blood from flowing in the opposite direction. The annular skirt can have an outer portion covering at least a portion of the outer surface of the frame and an inner portion covering at least a portion of the inner surface of the frame. The skirt can be folded around the inflow end of the frame so as to define a fold between the inner portion and the outer portion. The skirt can be sized so that when the frame is in an expanded configuration, the outer portion of the skirt conforms to the outer surface of the frame, and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame moves axially closer to the fold in the gap.

[0011] In some embodiments, the outer portion of the skirt may be secured to a row of struts defining the outflow end of the frame.

[0012] In some embodiments, when the frame is in the expanded configuration, the outer portion of the skirt can be stretched in a circumferential direction.

[0013] In some embodiments, the skirt may include a non-elastic fabric.

[0014] In some embodiments, the fabric may be woven in the warp and weft directions using polyethylene terephthalate fibers.

[0015] In some embodiments, the skirt may be woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, neither the first direction nor the second direction being perpendicular to the fold.

[0016] In some embodiments, the first direction may be generally perpendicular to the second direction. The second direction may form an angle of about 45 degrees relative to the fold.

[0017] In some embodiments, the valve structure can include a plurality of leaflets, each leaflet having an inflow edge portion.The inflow edge portions of the leaflets can define a wavy shape.

[0018] In some embodiments, the inner portion of the skirt can have a wavy outflow edge sewn to the inflow edge portion of the leaflet.

[0019] In some embodiments, the prosthetic valve can include a tether coupled to the skirt. The tether can be configured to prevent the fold from moving within the frame when the frame radially expands from the compressed configuration to the expanded configuration.

[0020] Certain embodiments of the present disclosure also relate to a prosthetic valve having an annular frame, a valve structure and an annular skirt. The annular frame may have an inflow end and an outflow end, and the frame may be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration. The valve structure may be positioned within the frame and configured to allow blood to flow through the prosthetic valve in one direction and to prevent blood from flowing in the opposite direction. The annular skirt may have a fold extending around the inflow end of the frame so as to cover at least a portion of the outer surface of the frame and at least a portion of the inner surface of the frame. When the frame is in a radially expanded configuration, the outer portion of the skirt may conform closely to the outer surface of the frame, and the inflow end of the frame may be axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in a radially compressed configuration, the inflow end of the frame may extend axially so as to at least partially fill the axially extending gap.

[0021] In certain embodiments, the valve structure can include a plurality of leaflets, each leaflet having an inflow edge portion, and the inflow edge portions of the leaflets can define a wavy, curved fan-shaped shape that circumferentially follows a plurality of interconnected strut segments of the frame when the frame is in a radially expanded configuration.

[0022] In certain embodiments, the outer portion of the skirt may be axially longer than the inner portion of the skirt.

[0023] In certain embodiments, when the frame is in the expanded configuration, the outer portion of the skirt can be stretched in a circumferential direction.

[0024] In certain embodiments, the prosthetic valve can include a tether coupled to the skirt and extending at an oblique angle relative to the longitudinal axis of the frame such that the tether can apply tension to the skirt to prevent movement of the fold within the frame as the frame radially expands from a compressed configuration to an expanded configuration.

[0025] The present invention also discloses a method for implanting a prosthetic valve mounted on a delivery device. The method may include delivering a prosthetic valve in a radially compressed configuration to a target location, the prosthetic valve including an annular frame and an annular skirt, the annular skirt having a folded portion around the inflow end of the frame so as to cover at least a portion of the outer surface of the frame and at least a portion of the inner surface of the frame. The method further includes expanding the prosthetic valve into a radially expanded configuration so that the outer portion of the skirt closely conforms to the outer surface of the frame, and the inflow end of the frame moves axially away from the folded portion, thereby forming an axially extending gap between the frame and the folded portion.

[0026] In certain embodiments, the prosthetic valve can further include a valve structure. The valve structure can include a plurality of leaflets, each leaflet having an inflow edge portion, and the inflow edge portions of the leaflets can define an undulating, curved, fan-shaped shape that circumferentially follows the plurality of interconnected strut segments of the frame when the frame is in the radially expanded configuration.

[0027] In certain embodiments, when the frame is in the expanded configuration, the outer portion of the skirt can be stretched in a circumferential direction.

[0028] In certain embodiments, when the frame is in the radially compressed configuration, the inflow end of the frame may extend axially all the way to the fold so as to completely fill the axially extending gap.

[0029] In certain embodiments, the prosthetic valve can include a tether coupled to the skirt. The tether can be configured to prevent movement of the fold within the frame when the frame radially expands from the compressed configuration to the expanded configuration.

[0030] The present invention further discloses an embodiment of a prosthetic valve, comprising an annular frame and an annular skirt covering at least a portion of the outer surface of the frame. The annular frame may have an inflow end and an outflow end, and the frame may be radially expanded and compressed between a radial compression configuration and a radial expansion configuration. The lower edge of the skirt may extend over the inflow end of the frame. The skirt may be attached to the frame by a plurality of sutures. The sutures may be positioned on a plurality of selected pillars of the frame so that the sutures form wavy, fan-shaped sutures. When the frame is in a radial expansion configuration, each suture may form an angle of about 45 degrees relative to the longitudinal axis of the frame. The skirt may be woven by a first group of inelastic fibers oriented in a first direction and a second group of inelastic fibers oriented in a second direction. The first direction may be generally perpendicular to the second direction, and the second direction may form an angle of about 45 degrees relative to the lower edge of the skirt. The skirt may be sized to closely conform to the outer surface of the frame when the frame is in a radial expansion configuration without any slack.

[0031] In some embodiments, the skirt can be folded around the inflow end of the frame so that the lower edge of the skirt defines a fold. When the frame is in a radially expanded configuration, the inflow end of the frame can be axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame can move axially closer to the fold within the gap.

[0032] In some embodiments, when the frame is radially compressed, the skirt can billow out to form folded flaps between the scalloped sutures.

[0033] In some embodiments, each flap can be folded circumferentially over its adjacent flap in order to maintain a low crimp profile of the prosthetic valve.

[0034] Certain embodiments of the present disclosure relate to a prosthetic valve comprising: an annular frame having an inflow end and an outflow end; at least one actuator mounted to the frame; and an annular skirt having a folded portion extending around the inflow end of the frame so as to cover at least a portion of the outer surface of the frame and at least a portion of the inner surface of the frame. The actuator can be configured to radially expand or compress the frame between a radially compressed configuration and a radially expanded configuration. When the frame is in a radially expanded configuration, the outer portion of the skirt can conform closely to the outer surface of the frame, and the inflow end of the frame can be axially spaced from the folded portion to form an axially extending gap between the frame and the folded portion. When the frame is in a radially compressed configuration, the inflow end of the frame can extend axially to at least partially fill the axially extending gap.

[0035] In some embodiments, the at least one actuator may be one of a plurality of actuators mounted to and equally spaced around the inner surface of the frame.

[0036] In some embodiments, at least one actuator can include a first anchor attached to a first location of the frame, a second anchor fixed to a second location of the frame, and a rod extending through the first anchor and the second anchor. The second location can be closer to the inflow end of the frame than the first location. The rod can be configured to increase or decrease the distance between the first location and the second location so as to radially compress or radially expand the frame, respectively.

[0037] In some embodiments, the rod can include external threads configured to matingly engage internal threads of the second anchor.

[0038] In some embodiments, the first location may be a junction between two stacked struts of the frame, and the first anchor may be hingedly connected to the junction by a fastener.

[0039] In some embodiments, at least one actuator can include a rod at least partially received within a sleeve, and axial movement of the rod relative to the sleeve can cause the frame to radially expand or compress.

[0040] In some embodiments, at least one actuator can include a locking mechanism configured to lock the frame in the radially expanded configuration.

[0041] In some embodiments, at least one actuator can include an attachment element configured to form a releasable connection with a corresponding actuation element of a delivery device such that the actuation element of the delivery device can apply a force to the at least one actuator to radially compress or expand the framework.

[0042] In some embodiments, the prosthetic valve can further include a valve structure positioned within the frame and configured to allow blood to flow through the prosthetic valve in one direction and to prevent blood from flowing in an opposite direction.

[0043] In some embodiments, the valve structure can include a plurality of leaflets, each leaflet having an inflow edge portion, and the inflow edge portions of the leaflets can define an undulating, curved fan-like shape that circumferentially follows the plurality of interconnected strut segments of the frame when the frame is in a radially expanded configuration.

[0044] In some embodiments, the outer portion of the skirt may be axially longer than the inner portion of the skirt.

[0045] In some embodiments, the outer portion of the skirt can have substantially the same axial length as the inner portion of the skirt.

[0046] In some embodiments, the outer portion of the skirt may be axially shorter than the inner portion of the skirt.

[0047] In some embodiments, when the frame is in the expanded configuration, the outer portion of the skirt can be stretched in a circumferential direction.

[0048] In some embodiments, the upper edge of the outer portion of the skirt can be generally straight prior to attachment to the frame.

[0049] In some embodiments, the upper edge of the outer portion of the skirt may be attached to the frame at a plurality of pivot joints formed by overlapping struts of the frame.

[0050] In some embodiments, the upper edge of the outer portion of the skirt may have a wavy shape and be sewn along the rows of strut sections of the frame.

[0051] In some embodiments, the prosthetic valve can further include a tether coupled to the skirt and extending at an oblique angle relative to the fold such that the tether applies tension to the skirt to prevent the fold from moving within the frame as the frame radially expands from the compressed configuration to the expanded configuration.

[0052] In some embodiments, the tilt angle may range from about 10° to about 80°. In some embodiments, the tilt angle may range from about 30° to about 60°. In some embodiments, the tilt angle may be about 45°.

[0053] In some embodiments, a first end of the tether may be located at an outflow edge portion of an outer side portion of the skirt, and a second end of the tether may be located adjacent the fold.

[0054] In some embodiments, the tether may include a stitch that is sewn to the outer portion of the skirt using in and out stitches.

[0055] In some embodiments, the tether may include an elastic material.

[0056] In some embodiments, the tether may be one of a plurality of tethers, each of which may form an oblique angle relative to the fold.

[0057] Certain embodiments of the present disclosure also relate to a prosthetic valve, comprising: an annular frame, the annular frame can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration; an annular skirt, the annular skirt having an outer portion covering at least a portion of the outer surface of the frame and an inner portion covering at least a portion of the inner surface of the frame; and a tether, the tether is connected to the skirt to prevent the fold from moving within the frame when the frame is radially expanded from the compressed configuration to the expanded configuration. The skirt can be folded around the inflow end of the frame so as to define a fold between the inner portion and the outer portion. The skirt can be sized so that when the frame is in the expanded configuration, the outer portion of the skirt can conform to the outer surface of the frame, and the inflow end of the frame can be axially spaced from the fold to form an axially extending gap between the frame and the fold, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame can move axially closer to the fold within the gap.

[0058] In some embodiments, the prosthetic valve can further include a valve structure positioned within the frame and configured to allow blood to flow through the prosthetic valve in one direction and to prevent blood from flowing in an opposite direction.

[0059] In some embodiments, the valve structure can include a plurality of leaflets, each leaflet having an inflow edge portion, and the inflow edge portions of the leaflets can define a wavy shape.

[0060] In some embodiments, the inner portion of the skirt can have a wavy outflow edge sewn to the inflow edge portion of the leaflet.

[0061] In some embodiments, the outer portion of the skirt may be secured to a row of struts defining the outflow end of the frame.

[0062] In some embodiments, when the frame is in the expanded configuration, the outer portion of the skirt can be stretched in a circumferential direction.

[0063] In some embodiments, the skirt may include a non-elastic fabric.

[0064] In some embodiments, the fabric can include polyethylene terephthalate fibers.

[0065] In some embodiments, the polyethylene terephthalate fibers may have a thickness of about 20 denier.

[0066] In some embodiments, the polyethylene terephthalate fibers may have an inter-fiber spacing of about 155 fibers / inch to about 180 fibers / inch. In some embodiments, the polyethylene terephthalate fibers may have an inter-fiber spacing of about 160 fibers / inch.

[0067] In some embodiments, the skirt may be woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, neither the first direction nor the second direction being perpendicular to the fold.

[0068] In some embodiments, the first direction can be generally perpendicular to the second direction, and the second direction forms an angle of about 45 degrees with respect to the fold.

[0069] In some embodiments, when the frame is in an expanded configuration, the first set of fibers can extend generally parallel to a first set of struts of the frame and the second set of fibers can extend generally parallel to a second set of struts of the frame, and the second set of struts can overlap the first set of struts to form a junction of the frame.

[0070] In some embodiments, when the frame is in the expanded configuration, the tethers can extend at an oblique angle relative to the fold, and the tethers can be configured to apply tension to the skirt.

[0071] In some embodiments, the tilt angle may be approximately 45°.

[0072] In some embodiments, a first end of the tether may be located at an outflow edge portion of an outer side portion of the skirt, and a second end of the tether may be located adjacent the fold.

[0073] In some embodiments, the tether may include a stitch that is sewn to the outer portion of the skirt using in and out stitches.

[0074] In some embodiments, the tether may include an elastic material.

[0075] Certain embodiments of the present disclosure also relate to a prosthetic valve, comprising: an annular frame that can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration; and an annular outer skirt that covers at least a portion of an outer surface of the frame. When the frame is in the radially compressed configuration, a portion of the outer skirt can be folded outward to form a longitudinally extending folded flap.

[0076] In some embodiments, each flap can be further folded in a circumferential direction to maintain a low crimp profile of the prosthetic valve.

[0077] In some embodiments, each fin may at least partially overlap an adjacent fin in a circumferential direction.

[0078] In some embodiments, the outer skirt may be connected to the struts of the frame along a zig-zag shaped attachment line.

[0079] In some embodiments, the outer skirt may be connected to the struts of the frame by stitching along a zigzag attachment line.

[0080] In some embodiments, the outer skirt may not be connected to any struts of the frame or other components of the prosthetic valve at locations that are not along the zigzag attachment line.

[0081] In some embodiments, the outer skirt may be connected to the frame only along a zigzag attachment line.

[0082] In some embodiments, the prosthetic valve can further include a plurality of leaflets, each leaflet having an inflow edge portion attached to a strut of the frame along a zigzag attachment line.

[0083] In some embodiments, the fins may be V-shaped.

[0084] In some embodiments, the prosthetic valve can further include an annular inner skirt covering at least a portion of the inner surface of the frame, and the outer skirt can be connected to the inner skirt by a fold extending around the inflow end of the frame.

[0085] In some embodiments, when the frame is in a radially expanded configuration, the outer skirt can be configured to closely conform to the outer surface of the frame, and the inflow end of the frame can be axially spaced from the folded portion to form an axially extending gap between the frame and the folded portion, and when the frame is in a radially compressed configuration, the inflow end of the frame can be configured to extend axially so as to at least partially fill the axially extending gap.

[0086] In some embodiments, when the frame is in the radially expanded configuration, the axial length of the gap can be in the range of about 4 mm to about 8 mm. In some embodiments, when the frame is in the radially expanded configuration, the axial length of the gap can be about 6 mm.

[0087] In some embodiments, when the frame is in the radially compressed configuration, the inflow end of the frame can extend axially to the gap and completely fill the gap.

[0088] In some embodiments, the inner skirt can be folded inwardly toward the interior of the frame when the frame is in the radially compressed configuration.

[0089] In some embodiments, the prosthetic valve can further include a tether coupled to the outer skirt and extending at an oblique angle relative to the fold such that the tether applies tension to the outer skirt to prevent the fold from moving within the frame as the frame radially expands from the compressed configuration to the expanded configuration.

[0090] In some embodiments, the tether may include stitches sewn to the outer skirt using in and out stitches.

[0091] In some embodiments, the tether may include an elastic material.

[0092] Certain embodiments of the present disclosure further relate to a method for assembling a prosthetic valve. The method may include receiving an annular frame that can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration, and attaching an annular skirt to the frame so that the skirt has an outer portion that covers at least a portion of the outer surface of the frame and an inner portion that covers at least a portion of the inner surface of the frame. The skirt can be folded around the inflow end of the frame so as to define a folded portion between the inner portion and the outer portion. The skirt can be sized so that when the frame is in an expanded configuration, the outer portion of the skirt can conform to the outer surface of the frame, and the inflow end of the frame can be axially spaced from the folded portion to form an axially extending gap between the frame and the folded portion, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame can move axially closer to the folded portion within the gap.

[0093] In some embodiments, attaching the annular skirt to the frame may include sewing an upper edge of an inner portion of the skirt to selected rows of strut segments of the frame from within the frame.

[0094] In some embodiments, attaching the annular skirt to the frame may include sewing an outer portion of the skirt to a row of struts defining an outflow end of the frame.

[0095] In some embodiments, the method can further include attaching a valve structure to the frame.The valve structure can be configured to allow blood to flow through the prosthetic valve in one direction and prevent blood from flowing in an opposite direction.

[0096] In some embodiments, the valve structure may include a plurality of leaflets, each leaflet having an inflow edge portion. The inflow edge portions of the leaflets may define a wavy shape. Attaching the valve structure to the frame may include suturing the inflow edge portions of the leaflets to the rows of interconnected strut segments of the frame from the interior of the frame in a circumferential direction.

[0097] In some embodiments, the method can further include coupling a tether to the skirt at an oblique angle relative to the fold to prevent movement of the fold within the frame when the frame radially expands from the compressed configuration to the expanded configuration.

[0098] Certain embodiments of the present disclosure further relate to a method comprising: receiving a prosthetic valve comprising an annular frame that can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration, and an annular skirt covering at least a portion of an outer surface of the frame; compressing the frame to a radially compressed configuration so that a portion of the skirt is folded outward to form a longitudinally extending folded wing; and folding the wing in a circumferential direction.

[0099] In some embodiments, the skirt may be sewn to the struts of the frame along zigzag lines of attachment.

[0100] In some embodiments, the prosthetic valve can include a plurality of leaflets, and each leaflet can have an inflow edge portion attached to a strut of the frame along a zigzag attachment line.

[0101] In some embodiments, the skirt may cover at least a portion of the inner surface of the frame and form a fold around the inflow end of the frame.

[0102] In some embodiments, the skirt can be sized so that when the frame is in an expanded configuration, the inflow end of the frame can be axially spaced from the folded portion to form an axially extending gap between the frame and the folded portion, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame can move axially closer to the folded portion within the gap.

[0103] In some embodiments, the prosthetic valve can further include a tether coupled to the skirt at an oblique angle relative to the fold to prevent movement of the fold within the frame when the frame radially expands from the compressed configuration to the expanded configuration.

[0104] In some embodiments, the method can further include loading the prosthetic valve into a sheath of a delivery device, inserting the prosthetic valve into a patient, advancing the prosthetic valve through the patient's vasculature to an implantation site, and radially expanding the prosthetic valve at the implantation site.

[0105] In some embodiments, radially expanding the prosthetic valve can cause the flaps to deploy.

[0106] In some embodiments, the skirt can closely conform to an outer surface of the frame when the frame is in the radially expanded configuration.

[0107] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0108] Figure 1 Shown is a perspective view of a prosthetic valve according to one embodiment.

[0109] Figure 2A Shown in radial compression configuration Figure 1 The frame of the prosthetic valve.

[0110] Figure 2B Shown in a partially radially expanded configuration Figure 1 The frame of the prosthetic valve.

[0111] Figure 2C Shown in fully radially expanded configuration Figure 1 The frame of the prosthetic valve.

[0112] Figure 3 Shown in radial compression configuration Figure 1 A side view of the prosthetic valve depicted in , the valve further comprising a skirt attached to the frame.

[0113] Figure 4 Shown in radially expanded configuration Figure 3 Side view of the prosthetic valve depicted in .

[0114] Figure 5 A side cross-sectional view of the prosthetic valve is shown when the prosthetic valve is fully expanded.

[0115] Figure 6 A side cross-sectional view of a prosthetic valve is shown when the prosthetic valve is partially compressed.

[0116] Figure 7 Shown is a side cross-sectional view of the outermost portion of a prosthetic valve when the prosthetic valve is fully compressed.

[0117] Figure 8 A plan view of the skirt is shown.

[0118] Fig. 9 A perspective view of a prosthetic valve according to an alternative embodiment is shown.

[0119] Fig.10 A perspective view of a radially expanded frame of a prosthetic valve according to another embodiment is shown.

[0120] Fig.11 Shows partially compressed Fig.10 The outer portion of the skirt is folded outwardly.

[0121] Fig. 12A Shows the fully compressed Fig. 9 The prosthetic valve is provided with a skirt, and the outer portion of the skirt is folded outward to form a folded flap.

[0122] Fig. 12B Shows Fig. 12A A fully compressed prosthetic valve in which the flaps are folded circumferentially.

[0123] Fig. 12C Shows Fig. 12B A cross-sectional view of a fully compressed prosthetic valve is depicted in FIG. DETAILED DESCRIPTION

[0124] Figure 1 An exemplary prosthetic valve 10 according to one embodiment is shown. In certain embodiments, although the prosthetic valve 10 can be implanted within the native aortic valve annulus, it can also be implanted in other locations in the heart, including within the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The prosthetic valve 10 can include an annular stent or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 can also include a valve structure 18 coupled to the frame 12 and supported within the frame 12. The valve structure 18 is configured to regulate blood flowing through the prosthetic valve 10 from the inflow end 14 to the outflow end 16.

[0125] Prosthetic valve 10 may further include one or more actuators 50 mounted to and equally spaced about the inner surface of frame 12. Each of actuators 50 may be configured to form a releasable connection with one or more corresponding actuators of a delivery device described further below.

[0126] The valve structure 18 may include, for example, a leaflet assembly including one or more leaflets 20 made of a flexible material. The leaflets 20 may be made in whole or in part of a biomaterial, a biocompatible synthetic material, or other such material. Suitable biomaterials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 may be fixed to each other at their adjacent sides to form commissures 22, each of which may be fixed to a corresponding actuator 50 or frame 12.

[0127] In the depicted embodiment, the valve structure 18 includes three leaflets 20, which can be arranged to collapse in a tricuspid arrangement. Each leaflet 20 can have an inflow edge portion 21. Figure 1As shown, the inflow edge portion 21 of the leaflet 20 can define a wavy, curved fan-shaped shape that follows or tracks the multiple interconnected strut segments of the frame 12 in the circumferential direction when the frame 12 is in a radially expanded configuration. The inflow edge of the leaflet can be referred to as a "fan line". In some embodiments, the inflow edge portion 21 of the leaflet 20 can be sutured to the struts generally along the fan line. By forming the leaflet 20 with such a fan-shaped geometry, the stress on the leaflet 20 is reduced, which in turn improves the durability of the valve 10. In addition, due to the fan-shaped shape, the folds and ripples of the belly of each leaflet 20 (the central area of ​​each leaflet) that can cause early calcification of those areas can be eliminated or at least minimized. The fan-shaped geometry also reduces the amount of tissue material used to form the valve structure 18, thereby allowing a smaller, more uniform curling profile at the inflow end 14 of the valve 10.

[0128] Further details regarding transcatheter prosthetic heart valves, including the manner in which the valve structure may be coupled to the frame 12 of the prosthetic valve 10, may be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202 and U.S. Patent Application No. 15 / 978,459, all of which are incorporated herein by reference in their entirety.

[0129] Prosthetic valve 10 is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Figure 2A-2C The bare frame 12 (without leaflets and other components) of the prosthetic valve 10 is shown for purposes of illustrating expansion of the prosthetic valve 10 from a radially compressed configuration to a radially expanded configuration. Figure 2A The frame 12 is shown in a radially compressed configuration, Figure 2B The frame 12 is shown in a partially expanded configuration, Figure 2C The frame 12 is shown in a fully radially expanded configuration.

[0130] In an exemplary embodiment, the prosthetic valve 10 can be mechanically expanded from a radial configuration to a radially expanded configuration. For example, the prosthetic valve 10 can be radially expanded by holding the inflow end 14 of the frame 12 in a fixed position while applying a force (F) in an axial direction toward the inflow end 14 against the outflow end 16. Alternatively, the prosthetic valve 10 can be expanded by applying an axial force against the inflow end 14 while holding the outflow end 16 in a fixed position, or by applying opposing axial forces to the inflow and outflow ends 14, 16, respectively.

[0131] In the illustrated embodiment, the expansion and compression forces are applied to the frame by actuator 50. Referring again to Figure 1, each of the actuators 50 may include a screw or threaded rod 52, a first anchor in the form of a cylinder or sleeve 54, and a second anchor in the form of a threaded nut 56. The rod 52 extends through the sleeve 54 and the nut 56. The sleeve 54 may be secured to the frame 12, for example, by a fastener that forms a hinge at the junction between the two struts. Each actuator 50 is configured to increase the distance between the attachment locations of the corresponding sleeve 54 and the nut 56, which causes the frame 12 to axially lengthen and radially compress, and to decrease the distance between the attachment locations of the corresponding sleeve 54 and the nut 56, which causes the frame 12 to axially shorten and radially expand.

[0132] For example, each rod 52 may have external threads that mesh with internal threads of nut 56, so that rotation of the rod causes corresponding axial movement of nut 56 toward or away from sleeve 54 (depending on the direction of rotation of rod 52). This causes the hinges supporting sleeve 54 and nut 56 to move closer to each other to radially expand the frame, or move away from each other to radially compress the frame, depending on the direction of rotation of rod 52.

[0133] In other embodiments, the actuator 50 can be a reciprocating type actuator configured to apply an axial force to the frame to produce radial expansion and compression of the frame. For example, the rod 52 of each actuator can be axially fixed relative to the sleeve 56 and slide relative to the sleeve 54. Thus, in this manner, moving the rod 52 distally relative to the sleeve 54 and / or moving the sleeve 54 proximally relative to the rod 52 causes the frame to be radially compressed. Conversely, moving the rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the rod 52 causes the frame to be radially expanded.

[0134] When a reciprocating actuator is used, the prosthetic valve may also include one or more locking mechanisms that hold the frame in the expanded state. The locking mechanism may be a separate component mounted on the frame separate from the actuator, or it may be a subcomponent of the actuator itself.

[0135] Each rod 52 can include an attachment element 58 along a proximal portion of the rod 52 that is configured to form a releasable connection with a corresponding actuator of a delivery device. The actuator(s) of the delivery device can apply a force to the rod to radially compress or expand the prosthetic valve 10. The attachment element 58 in the example configuration includes a notch 60 and a projection 62 that can engage a corresponding projection of the actuator of the delivery device.

[0136] In the illustrated embodiment, although the prosthetic valve 10 includes three such actuators 50, a greater or lesser number of actuators may be used in other embodiments. The leaflet 20 may have a coupling attachment element 64 that wraps around the sleeve 54 of the actuator 50. Further details of the actuator, locking mechanism, and delivery device for actuating the actuator can be found in U.S. Patent Application Nos. 62 / 548,855, 62 / 430,810, 15 / 831,197 (published as U.S. Publication No. 2018 / 0153689) and 15 / 978,459, each of which is incorporated herein by reference in its entirety. Each of the actuators and locking mechanisms disclosed in the previously filed applications may be incorporated into any of the prosthetic valves disclosed herein. Further, each of the delivery devices disclosed in the previously filed applications may be used to deliver and implant any of the prosthetic valves disclosed herein.

[0137] The frame 12 can be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloys, or nickel-titanium alloys ("NiTi"), such as Nitinol. As shown, the frame 12 can include a plurality of interconnected struts 24 arranged in a lattice-type pattern. When the prosthetic valve 10 is in the expanded configuration, the struts 24 are shown as being diagonally positioned, or offset at an angle and radially offset relative to the longitudinal axis 26 of the prosthetic valve 10. In other embodiments, the offset of the struts 24 can be as large as 1 / 2 of the longitudinal axis 26 of the prosthetic valve 10. Figure 2B and 2C Differently from the amounts depicted in , some or all of the struts 24 may be positioned parallel to the longitudinal axis 26 of the prosthetic valve 10 .

[0138] In the depicted embodiment, the struts 24 are pivotally coupled to each other at one or more pivot joints along the length of each strut. For example, in the illustrated configuration, each of the struts 24 can be formed with holes at opposite ends of the strut and holes spaced along the length of the strut. Corresponding hinges can be formed at locations where the struts 24 overlap each other by fasteners, such as rivets or pins 28 extending through the holes. The hinges can allow the struts 24 to pivot relative to each other when the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic valve 10.

[0139] In the depicted embodiment, struts 24 are arranged in five rows (I, II, III, IV, and V) from inflow end 14 to outflow end 16. Each row is defined by strut segments extending in a zigzag pattern between adjacent circumferential rows of hinges 28. For example, first row I is defined by strut segments 25 extending between a first row of hinges 28a and an adjacent row of hinges 28b at the inflow end of the frame. In other embodiments, the segments of struts 24 may be arranged in a different number of rows.

[0140] In some embodiments, the frame 12 can be constructed by forming individual components (e.g., the struts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts 24 are not interconnected by corresponding hinges, but pivot or bend relative to each other in other ways to allow the frame 12 to expand and contract radially. For example, the frame 12 can be formed from a single piece of material (e.g., a metal tube) (e.g., by laser cutting, electroforming, or physical vapor deposition). Further details about the frame and prosthetic valve construction are described in U.S. Patent Application Nos. 15 / 831,197; 15 / 995,528; and 62 / 548,855, all of which are incorporated herein by reference. Additional examples of expandable prosthetic valves that can be used with the delivery devices disclosed herein are described in U.S. Publication Nos. 2015 / 0135506 and 2014 / 0296962, which are incorporated herein by reference.

[0141] In other embodiments (not shown), the frame can be made of any of various suitable plastically expandable materials known in the art (e.g., stainless steel, cobalt-chromium alloy, etc.) or self-expanding materials (e.g., nitinol). When constructed of plastically expandable materials, the frame (and valve) can be curled into a radially compressed configuration on a delivery device and then expanded in the patient's body by an inflatable balloon or other suitable expansion mechanism. When constructed of self-expanding materials, the frame (and therefore the valve) can be curled into a radially compressed configuration and be restricted in a compressed configuration by being inserted into a sheath or equivalent mechanism of a delivery device. After entering the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0142] like Figure 3-7 As shown, prosthetic valve 10 may further include an annular skirt 30 attached to frame 12 . Figure 8 A plan view of the skirt 30 is shown.

[0143] The skirt 30 in the example embodiment may have an inner portion 32 and an outer portion 34. Specifically, the skirt 30 may extend along the inner surface of the frame 12, around the inflow end 14 of the frame 12, and then along the outer surface of the frame to define a fold 36 between the inner portion 32 and the outer portion 34. When attached to the frame 12, the inner portion 32 may cover at least a portion of the inner surface of the frame 12, and the outer portion 34 may cover at least a portion of the outer surface of the frame 12.

[0144] Inner portion 32 of skirt 30 can act as a sealing element to prevent or reduce paravalvular leakage and anchor leaflet 20 to frame 12. Outer portion 34 of skirt 30 can act as a sealing element for prosthetic valve 10 by sealing against tissue of the native annulus and helping to reduce paravalvular leakage through prosthetic valve 10.

[0145] like Figure 8 As best shown in FIG. 1 , the upper edge 38 of the medial portion 32 (which is the outflow edge of the medial portion in the example embodiment) can have a wavy shape that generally follows the shape of the selected row of strut segments 22 of the frame 12 when the frame 12 is in the expanded configuration. In this way, the upper edge 38 of the medial portion 32 can be tightly secured to the selected row of strut segments 22 by sutures. For example, in some embodiments, the upper edge 38 of the medial portion 32 can be sutured to the II row of strut segments. In other embodiments, the upper edge 38 of the medial portion 32 can be sutured to the III row of strut segments.

[0146] In certain embodiments, the suture(s) used to secure the upper edge 38 extend only around the strut segments that are aligned with the scallop line defined by the leaflet 20 (the line that tracks the inflow edge portion 21 of the leaflet). In some embodiments, the upper edge 38 of the medial portion 32 is "sandwiched" between the frame 12 and the leaflet 20. For example, the inflow edge portion 21 of the leaflet can overlap a portion of the inner surface of the medial portion 32 along the upper edge 38, and the leaflet can be secured to the medial portion 32 by sutures extending through the inner surface of the medial portion 32.

[0147] In the depicted embodiment, the upper edge 40 of the outer portion 34 (which in the illustrated embodiment is the outflow edge of the outer portion) is generally straight and can be attached to the frame at a pivot joint just below the V-row strut segments (see, e.g., Figure 4 In an optional embodiment (not shown), the upper edge 40 of the outer portion 34 may also have a wavy shape (similar to the upper edge of the inner portion 32) so that it can be sutured along a selected row of strut segments (e.g., the Vth row of strut segments).

[0148] In the depicted embodiment, the outer portion 34 of the skirt 30 is axially longer than the inner portion 32 of the skirt 30 , ie, the upper edge 40 of the outer portion 34 extends closer to the outflow end 16 of the frame than the upper edge 38 of the inner portion 32 .

[0149] Although not shown, in an alternative embodiment, the axial length of the outer portion 34 may be the same or substantially the same as the axial length of the inner portion 32. Alternatively, the outer portion 34 may be axially shorter than the inner portion 32, i.e., the upper edge 38 of the inner portion 32 may extend closer to the outflow end 16 of the frame than the upper edge 40 of the outer portion 34.

[0150] As described above, to deploy the prosthetic valve 10, the frame 12 is radially expanded to a larger diameter (i.e., the deployment diameter). The deployment diameter can be within a working range of diameters defined between a minimum deployment diameter and a maximum deployment diameter. In an exemplary but non-limiting embodiment, the minimum deployment diameter is about 26 mm and the maximum deployment diameter is about 29 mm.

[0151] In certain embodiments, when the frame 12 is radially expanded (see, e.g., Figure 4-5 ), the outer portion 34 of the skirt 30 can be slightly stretched in the circumferential direction. In certain embodiments, the skirt 30 can be sized so that when the frame 12 is expanded to a diameter within the working range, the outer portion 34 of the skirt 30 can be stretched to conform closely or snugly to the outer surface of the frame 12, i.e., no slack is formed in the outer portion 34 around the circumference of the frame 12.

[0152] For example, during assembly of the prosthetic valve 10, when the frame 12 is expanded to its minimum deployment diameter, the skirt 30 can be sutured to the frame 12. The skirt 30 can be sized so that when the frame 12 is expanded to its minimum deployment diameter, the outer portion 34 conforms closely to the outer surface of the frame 12 without any slack in the radial direction. This close conformity of the skirt 30 on the outer surface of the frame 12 can prevent the skirt 30 from protruding through the frame unit, thereby preventing the leaflets 20 from wearing.

[0153] When the frame 12 is radially expanded to a larger diameter within the working range of deployment diameters, the outer portion 34 of the skirt 30 can be further tightened on the frame 12. Therefore, in some embodiments, it can be ensured that when the frame 12 is expanded to any diameter within the working range, there is no slack in the radial direction of the outer portion 34. In some embodiments, in order to ensure that the outer portion 34 fits tightly around the frame 12 at its minimum deployment diameter, the skirt 30 can be cut to a smaller size and the skirt 30 can be installed on the frame 12 (at its minimum deployment diameter) with some stretch in the circumferential direction.

[0154] In other embodiments, the skirt 30 can be sized to fit snugly around the frame 12 when it is expanded to its minimum deployed diameter without stretching the skirt in any direction and without any slack in the radial direction. The skirt 30 can stretch and tighten slightly around the frame when the frame is radially expanded to a larger diameter within the working range.

[0155] In some embodiments, the prosthetic valve may have only one deployment diameter. In this case, the skirt 30 may be sized to fit snugly around the frame 12 when it is expanded to the deployment diameter without stretching the skirt in any direction and without any slack in the radial direction. In other embodiments, the skirt 30 may be sized so that it stretches slightly in the circumferential direction when the frame is expanded to the deployment diameter.

[0156] Additionally, when the frame 12 is radially expanded, the inflow end 14 of the frame 12 may be axially spaced from the folded portion 36 to form an axially extending gap 42 between the inflow end 14 of the frame 12 and the folded portion 36 (see, e.g., Figure 5 ). In some embodiments, the length (L) of the gap 42 may be in the range of about 4 mm to about 8 mm. In a particular embodiment, the length L of the gap 42 may be about 6 mm.

[0157] When the frame 12 is radially compressed during curling (see, e.g., Figure 6-7 ), the inflow end 14 of the frame 12 can move axially closer to the fold 36 within the gap 42. In some embodiments, when the frame 12 is in the fully compressed configuration, the inflow end 14 of the frame 12 can extend all the way to the fold 36, so that the frame 12 completely fills the gap 42. In addition, when the frame 12 is in the radially compressed configuration, the outer portion 34 of the skirt 30 can be formed as shown in FIG. Figure 3 At the same time, the inner portion 32 of the skirt 30 can be folded inwardly toward the interior of the frame 12.

[0158] The skirt 30 can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue). In certain embodiments, the skirt 30 is generally inelastic. For example, the skirt 30 can be woven using PET fibers or yarns in warp (longitudinal) and weft (circumferential) directions using a plain weave design. In a particular embodiment, the skirt can be assembled on the frame such that the warp fibers extend in the axial direction of the frame and the weft fibers extend in the circumferential direction of the frame. In an optional embodiment, the skirt can be assembled on the frame such that the weft fibers extend in the axial direction of the frame and the warp fibers extend in the circumferential direction of the frame.

[0159] In other embodiments, even if the skirt 30 is still woven with non-elastic fibers, it can be stretched to a certain extent in both the radial and axial directions. For example, this pseudo-elasticity can be achieved by orienting the fibers at an angle relative to the height of the skirt and / or increasing the spacing between the fibers. For example, Figure 8As shown, the skirt 30 may be woven from a first set of fibers (or yarns or strands) extending in a first direction 44 and a second set of fibers (or yarns or strands) extending in a second direction 46 , wherein both the first direction 44 and the second direction 46 are not perpendicular to the fold 36 .

[0160] In particular embodiments, the first direction 44 can be generally perpendicular to the second direction 46, and the second direction can extend at an angle α of about 45 degrees (e.g., between 15-75 degrees or between 30-60 degrees) relative to the fold 36. In particular embodiments, when the frame 12 is in its radially expanded state, the first direction 44 extends parallel to or substantially parallel to the outer struts 24a and the second direction 46 extends parallel to or substantially parallel to the inner struts 24b.

[0161] In some embodiments, the spacing between the braided fibers (or yarns or strands) can be increased to facilitate elongation of the skirt 30 in the radial and axial directions. For example, for a PET skirt 30 formed of 20 denier yarns, the yarn density can be about 15% to about 30% less than a conventional PET skirt. In some examples, the yarn spacing of the skirt 30 can be about 155 yarns / inch to about 180 yarns / inch, such as about 160 yarns / inch, while in a conventional PET skirt, the yarn spacing can be about 217 yarns / inch to about 247 yarns / inch.

[0162] In some embodiments, the fibers can be oriented so that they are parallel or substantially parallel to the struts and / or increasing the spacing between the fibers can allow the skirt 30 to stretch up to about 40% in the axial and / or circumferential directions. For example, in some embodiments, rotation of the fibers and / or increasing the spacing between the fibers can allow the skirt 30 to stretch up from a minimum deployment diameter to a maximum deployment diameter in the circumferential direction.

[0163] Because only the upper edge 40 of the outer portion 34 of the skirt 30 is attached to the frame 12 in the illustrated embodiment, the outer portion 34 of the skirt 30 does not restrict the axial extension of the frame 12 when the frame is radially compressed. Therefore, the frame 12 is free to move axially within the axially extending gap 42 toward the fold 36 during crimping. Therefore, a relatively low crimping force is required to crimp the prosthetic valve 10, and excessive stretching of the skirt 30 can be avoided.

[0164] In some embodiments, a tether 48 can be coupled to the skirt 30 to prevent movement of the folds 36 within the frame 12 as the frame 12 radially expands from the compressed configuration to the expanded configuration.

[0165] For example, the skirt 30 may include a tether 48 extending diagonally from a first end 48a to a second end 48b located at or near the fold 36 such that the tether 48 forms an oblique angle relative to the fold 36 (see, e.g., Figure 3 ). In some embodiments, the angle between the tether 48 and the fold 36 can be in the range of about 10° to about 80°. In some embodiments, the angle between the tether 48 and the fold 36 can be in the range of about 30° to about 60°. In a specific embodiment, the angle between the tether 48 and the fold 36 can be about 45°.

[0166] In a particular embodiment, the first end 48a can be located at the upper edge 40 of the outer portion 34. In another embodiment, the first end 48a can be spaced from the upper edge 40. In an alternative embodiment, the first end 48a can be attached to the upper portion of the frame 12. In some embodiments (not shown), more than one tether 48 can be coupled to the skirt 30, wherein each tether 48 extends at an oblique angle relative to the fold 36.

[0167] In some embodiments, the tether 48 can be formed by a suture that is sewn to the outer portion 34 of the skirt using, for example, in-and-out stitches, as depicted in 3 and 4. Due to the in-and-out stitches, the length of the suture can be longer than the distance the suture travels, so that the suture can stretch if stretched. In this way, the suture can act like a coil that returns to its original length after being stretched. In other embodiments, the tether 48 can be formed by an elastic material (e.g., an elastic fabric) that can stretch longitudinally when tension is applied along its length, and then return to its original length when the tension is removed.

[0168] Thus, when the frame 12 radially expands from the compressed configuration to the expanded configuration, the tethers 48 can stretch in the longitudinal direction of the tethers due to the radial expansion of the outer portion 34 of the skirt. As a result, the tethers 48 are relatively taut and can hold the fold 36 in place against hemodynamic forces. Thus, when the frame 12 is in the expanded configuration, the tethers 48 can prevent the fold 36 from moving within the frame 12, which could otherwise impede fluid flow through the valve 10. When the frame 12 is radially compressed, the tethers 48 can return to their original length.

[0169] The above-described prosthetic valve 10 can be mounted on a delivery device and delivered to a target location in a patient's body. Various embodiments of delivery devices and methods for delivering prosthetic valves have been described, for example, in U.S. Patent Application Publication Nos. 2013 / 0030519, 2010 / 0049313, 2009 / 0281619, 2008 / 0065011, and 2007 / 0005131 and U.S. Patent Application No. 15 / 831,197, the disclosures of which are incorporated herein by reference.

[0170] In order to mount the prosthetic valve 10 on the delivery device, the prosthetic valve 10 can be crimped onto the shaft of the delivery device. During crimping, the diameter of the frame 12 is reduced, while the axial length of the frame 12 is elongated. By using a fabric with angled fibers and / or increased spacing between fibers, the skirt 30 can be elongated in the axial direction. Further, since the frame 12 is not constrained by the outer portion 34 of the skirt 30, the frame 12 is free to elongate in the axial direction, and the inflow end 14 of the frame 12 can extend into the gap 42 during crimping. As described above, when the frame 12 is radially compressed, the outer portion 34 of the skirt 30 can form longitudinal folds and the inner portion 32 of the skirt 30 can fold inwardly.

[0171] After delivery to the target location, the prosthetic valve 10 can be expanded until the diameter of the frame 12 is within its working range. During expansion, the diameter of the frame 12 increases, while the axial length of the frame 12 decreases. When the prosthetic valve 10 is in a radially expanded configuration, in a particular embodiment, the outer portion 34 of the skirt 30 can be stretched circumferentially so that it can conform closely to the outer surface of the frame 12 without any slack in the radial direction. At the same time, the inflow end 14 of the frame 12 can move away from the fold 36 to form an axially extending gap 42 between the frame 12 and the fold 36. In some embodiments, one or more tethers 48 can be connected to the skirt 30 to prevent the fold 36 from moving within the frame 12 during valve expansion.

[0172] Fig. 9 A prosthetic valve 110 according to another embodiment is shown. The prosthetic valve 110 includes a frame 112 that can be radially expanded and compressed between a radially compressed configuration and a radially expanded configuration. Similar to the prosthetic valve 10, the prosthetic valve 110 can include a valve structure 118 attached to the frame 112, and the valve structure 118 can include a plurality of leaflets 120 ( Fig. 9 Three leaflets are shown in Figure ).

[0173] The prosthetic valve 110 can further include an outer skirt 130 that covers at least a portion of the outer surface of the frame 112. For example, a lower edge 136 of the skirt 130 (an inflow edge in the illustrated embodiment) can extend from the inflow end 114 of the frame 112, while an upper edge 140 of the skirt 130 (an outflow edge in the illustrated embodiment) can be offset from the outflow end 116 of the frame 112. In the depicted embodiment, the frame 112 has five rows of strut segments, and only the rows of strut segments defining the outflow end 116 are not covered by the skirt 130. In other embodiments, the skirt 130 can be sized to cover the inflow end 114 of the frame 112. Fig. 9 The skirt 130 may be folded around the inflow end 114 of the frame to form a similar Figure 5 The gap is depicted as an axially extending gap 42 .

[0174] like Fig. 9 As shown, the skirt 130 can be sutured to the strut sections 124 of the frame 112 along a scalloped line 121 defined by the inflow edge of the leaflet 120. In the illustrated embodiment, the scalloped line 121 is a zigzag attachment line for the skirt 130 and the inflow edge of the leaflet 120. In some embodiments, the suture 122 can be positioned to wrap around a plurality of struts such that the suture 122 is positioned along a path that generally follows the scalloped line 121. Fig. 9 As shown, when the frame 112 is in the expanded configuration, each segment of the fan line 121 (where the inflow edge of the leaflet 120 is attached to the frame 112) forms an angle of approximately 45 degrees relative to the longitudinal axis 126 of the frame 112. During the crimping of the frame 112, the strut segments along the fan line 121 move inward. Therefore, those sutures 122 along the fan line 121 do not apply stress to the skirt 130. In some embodiments, some of the sutures 122 along the fan line 121 are configured to slide along the struts. Such sliding sutures can further reduce the stress on the skirt 130 when the frame 112 is radially compressed or expanded.

[0175] In certain embodiments, outer skirt 130 is connected to the frame only along attachment line 121 ; that is, outer skirt is not connected to any struts of the frame or other components of the prosthetic valve at locations not along attachment line 121 .

[0176] In some embodiments, the outer skirt 130 is connected to the struts of the frame along the attachment lines 121 , while the inflow edge portions of the leaflets 120 need not be connected to the frame along the attachment lines 121 .

[0177] Fig.10A prosthetic valve 210 according to another embodiment is shown. Similar to the valve 110 discussed above, the valve 210 includes a radially compressible and expandable frame 212 and an outer skirt 230 covering at least a portion of the outer surface of the frame 212. As with the valve 110, the skirt 230 can be secured to the frame 212 by sutures 222 along a predetermined scallop line 221 (a zigzag attachment line for the skirt in the illustrated embodiment). Fig.10 The valve structure is not shown in the figure, so that the sutures 221 on the back of the frame 212 can be clearly seen. The frame 212 in the example embodiment has four rows of strut segments, and the two rows of strut segments closest to the outflow end 216 are not covered by the skirt 230.

[0178] Similar to the skirt 30 discussed above, the fabric of the skirt 130 or 230 can use a non-elastic fiber weave that is rotated (e.g., 45 degrees) and optionally increases the spacing between fibers, so that the skirt 130 or 230 can accommodate a certain degree of radial and axial elongation. Likewise, the skirt 130 or 230 can be sized so that when the corresponding frame 112 or 212 is expanded to its minimum working diameter, it conforms closely to the outer surface of the corresponding frame 112 or 212 without any slack.

[0179] Fig. 12A It is shown that when the frame 112 is radially compressed, portions of the skirt 130 can be folded outward to form V-shaped, longitudinally extending folded flaps 150 between adjacent portions of the scalloped suture 121. In some embodiments, each flap 150 can be further folded in the circumferential direction to maintain a low curl profile of the valve 110. As shown, each flap 150 can overlap with adjacent flap portions in the circumferential direction, depending on the number and size of each flap. For example, Figures 12B-12C The flap 150 is shown folded in a clockwise direction (as viewed from the outflow end), but it is understood that the flap 150 may also be folded in a counter-clockwise direction.

[0180] Likewise, when the frame 212 is radially compressed, as shown in FIG. Fig.11 As shown, the skirt 230 can be folded outward to form a V-shaped, longitudinally extending folded flap 250 between adjacent sections of the seam 221. To maintain a low curl profile, it is desirable to perform a patterned folding of the flap 250 by wrapping the flap 250 in a circumferential direction, similar to Figures 12B-12C Implementation examples in .

[0181] In the illustrated embodiment, the inflow and outflow edges of skirts 130 and 230 are not connected to the frame or other components of the prosthetic valve except along the attachment lines 121, 221, which form a plurality of first V-shaped wing openings toward the outflow end of the prosthetic valve, such that the plurality of first V-shaped wing openings alternate around the circumference of the frame with a plurality of second V-shaped wing openings toward the inflow end of the prosthetic valve (e.g., Fig.11 best shown in ).

[0182] General considerations

[0183] It should be understood that the disclosed embodiments may be suitable for delivery and implantation of prosthetic devices in any of the natural valve annuli of the heart (e.g., pulmonary, mitral, and tricuspid annuli) and may be used with any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0184] For the purpose of this specification, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as limiting in any way. On the contrary, the present disclosure is directed to all novel and non-obvious features and aspects of various disclosed embodiments individually and in various combinations and sub-combinations with each other. The methods, devices and systems are not limited to any specific aspects or features or combinations thereof, and the embodiments of the present disclosure do not require the existence of any one or more specific advantages or problems to be solved. The technology from any example can be combined with the technology described in any one or more of the other examples. In view of the various possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are only representative examples and should not be regarded as limitations on the scope of the disclosed technology.

[0185] Although some of the operations in the embodiments of the present disclosure are described in a specific, continuous order for the convenience of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a specific order. For example, the operations described in sequence can be rearranged or performed simultaneously in some cases. In addition, for simplicity, the accompanying drawings may not show the various ways in which the method of the present disclosure can be used in combination with other methods. In addition, the specification sometimes uses terms such as "providing" or "implementing" to describe the method of the present disclosure. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms can vary according to the specific implementation and can be easily distinguished by a person of ordinary skill in the art.

[0186] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "includes". Further, the terms "coupled" and "connected" generally mean electrical, electromagnetic, and / or physical (e.g., mechanical or chemical) couplings or connections, and do not exclude the presence of intervening elements between coupled or associated items in the absence of specific language to the contrary.

[0187] Direction and other related references (e.g., inside, outside, up, down, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as "inside," "outside," "top," "below," "inside," "outside," etc. may be used. Where applicable, such terms are used to provide some clarity when dealing with related relationships, particularly with respect to example embodiments. However, these terms are not intended to imply absolute relationships, positions, and / or directions. For example, with respect to an object, the "upper" portion may become the "lower" portion simply by turning the object over. Nevertheless, it is still the same portion, and the object remains unchanged. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0188] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention, which is instead defined by the following claims.

Claims

1. A prosthetic valve, comprising: an annular frame capable of radially expanding and compressing between a radially compressed configuration and a radially expanded configuration; a valve structure positioned within the frame and configured to allow blood to flow through the prosthetic valve in one direction and to prevent blood from flowing in an opposite direction; and an annular skirt having an outer portion covering at least a portion of an outer surface of the frame and an inner portion covering at least a portion of an inner surface of the frame, wherein the skirt is folded about an inflow end of the frame to define a fold between the inner and outer portions; The skirt is sized so that when the frame is in the expanded configuration, the outer portion of the skirt conforms to the outer surface of the frame, and the inflow end of the frame is axially spaced from the folded portion to form an axially extending gap between the frame and the folded portion, and when the frame is radially compressed from the expanded configuration to the compressed configuration, the inflow end of the frame moves axially closer to the folded portion within the gap.

2. The prosthetic valve of claim 1, wherein the outer portion of the skirt is secured to a row of struts defining an outflow end of the frame.

3. The prosthetic valve of any of the preceding claims, wherein the outer portion of the skirt is stretched in a circumferential direction when the frame is in the expanded configuration.

4. The prosthetic valve of any of the preceding claims, wherein the skirt comprises a non-elastic fabric.

5. The prosthetic valve of claim 4, wherein the fabric is woven in warp and weft directions using polyethylene terephthalate fibers.

6. The prosthetic valve of any of the preceding claims, wherein the skirt is woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, neither of the first direction nor the second direction being perpendicular to the fold.

7. The prosthetic valve of claim 6, wherein the first direction is generally perpendicular to the second direction, the second direction forming an angle of approximately 45 degrees relative to the fold.

8. The prosthetic valve of any of the preceding claims, wherein the valve structure comprises a plurality of leaflets, each leaflet having an inflow edge portion, wherein the inflow edge portions of the leaflets define a wavy shape.

9. The prosthetic valve of claim 8, wherein the inner portion of the skirt has a wavy outflow edge sewn to the inflow edge portion of the leaflet.

10. The prosthetic valve of any of the preceding claims, further comprising a tether coupled to the skirt, wherein the tether is configured to prevent movement of the fold within the frame when the frame radially expands from the compressed configuration to the expanded configuration.

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