Prosthetic valve

Abstract

To provide a novel prosthetic valve for implantation into body ducts, such as native heart valve annuluses.SOLUTION: 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 an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. When the frame is in the radially expanded configuration, an outer portion of the skirt tightly 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.SELECTED DRAWING: Figure 9

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 797,837, filed on January 28, 2019, which is incorporated herein by reference.

[0002] The present disclosure relates to embodiments of prosthetic valves for implantation into body conduits such as the native heart annulus, and methods of implanting prosthetic valves.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can lead to significant cardiac dysfunction and may ultimately require replacement of the native valve with an artificial valve. There are several known artificial valves and several known methods of implanting these artificial valves into humans. Due to the drawbacks associated with conventional open - heart surgery, minimally invasive percutaneous surgical techniques have received significant attention. In one technique, prosthetic heart valves are configured to be implanted with a much lower invasive procedure using a catheter method. For example, a prosthetic heart valve can be mounted in a collapsed state at the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. Next, the prosthetic valve is expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, or by deploying the prosthetic valve from the sheath of the 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 remains a need for improved prosthetic valves and methods for the delivery of such valves.

[0004] Known prosthetic valves can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, a prosthetic valve can be compressed radially in a delivery device during delivery and then expanded to a radially expanded state when the prosthetic valve reaches the implantation site.

[0005] A patch valve typically includes a frame on which a valve structure (e.g., a valve tip) is mounted, an inner skirt fixed inside the frame, and optionally an outer skirt fixed outside the frame. The inner skirt can serve several functions. For example, the inner skirt can function as a sealing member to prevent (or reduce) leakage beside the valve and to moor the valve tip to the frame. The outer skirt can cooperate with the inner skirt to further reduce or avoid leakage beside the valve after valve implantation. The inner skirt and the outer skirt can be fixed to the frame by stitching or sewing the fabric of each skirt to the frame.

[0006] The inner skirt preferably includes a strong and tear-resistant material such as polyethylene terephthalate (PET), although a variety of other synthetic or natural materials can be used. Skirts formed from conventional woven PET or similar fabrics are substantially inelastic and thus can hardly be stretched. If the skirt has no elasticity, it may make it difficult to shrink the prosthetic valve. For example, shrinking the prosthetic valve attempts to increase the length of the frame axially while decreasing the diameter of the frame. Since the skirt is usually sewn to the frame, the inelasticity of the skirt may limit the axial elongation of the frame. In some situations, shrinking creates substantial stress in the fabric at the sewing location, which can lead to sewing tear, fabric tear, or frame distortion. Further, depending on how the skirt is sewn to the frame, the constraints on the skirt during shrinking are localized, so that some regions of the skirt may conform to the frame more tightly than other regions. Such non-uniform tightening can result in an undesirable uneven attachment of the skirt to the frame and can further cause sewing and / or fabric tear, or frame distortion. One possible solution to this problem is to size the skirt such that there is a radial slack when the prosthetic valve is in the radially expanded state. The slack allows for axial elongation of the prosthetic valve during the shrinking process without being restricted or constrained by the skirt. However, excessive fabric use can increase the radial profile of the prosthetic valve, which is disadvantageous for catheter-based valve implantation. Also, loose fabric may protrude through the frame compartments and contact the valve tip, causing undesirable wear of the valve tip. Therefore, improvements to the skirt for prosthetic valves are desired.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

[0008] Described herein are examples of prosthetic valves and related methods of implanting prosthetic valves. The prosthetic valves disclosed herein can be implanted within any of the heart's native valves (aortic, mitral, tricuspid, and pulmonary valves). In some embodiments, the prosthetic valve can be delivered through the vasculature using a delivery device and implanted into a patient's heart.

[0009] Certain embodiments of the present disclosure relate to prosthetic valves having an annular frame, a valve structure, and an annular skirt. The annular frame can be radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The valve structure can be positioned within the frame and configured to permit blood flow through the prosthetic valve in one direction and to block blood flow in the opposite direction. The annular skirt can have 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 fold between the inner and outer portions. The skirt can be sized such 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 fold to form an axially extending gap between the frame and the fold, and such that 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 within the gap.

[0010] In some embodiments, the outer portion of the skirt can be secured to a row of struts that define the outflow end of the frame.

[0011] In some embodiments, the outer portion of the skirt can be circumferentially stretched when the frame is in the expanded configuration.

[0012] In some embodiments, the skirt can comprise a non-elastic fabric.

[0013] In some embodiments, the fabric can be woven using polyethylene terephthalate fibers in both the warp and weft directions.

[0014] In some embodiments, the skirt can be woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, where neither the first direction nor the second direction is perpendicular to the fold.

[0015] In some embodiments, the first direction can be generally perpendicular to the second direction. The second direction can form an angle of about 45 degrees with respect to the fold.

[0016] In some embodiments, the valve structure can include a plurality of valve tips, each valve tip having an inlet edge portion. The inlet edge portion of the valve tip can define a wavy shape.

[0017] In some embodiments, the inner portion of the skirt can have a wavy outlet edge that is stitched to the inlet edge portion of the valve tip.

[0018] In some embodiments, the patch valve can include a tether coupled to the skirt. The tether can be configured to prevent the fold from moving inside the frame when the frame expands radially from a compressed configuration to an expanded configuration.

[0019] 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 can have an inflow end and an outflow end, and the frame can be radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The valve structure can be positioned within the frame and configured to permit blood flow through the prosthetic valve in one direction and to block blood flow in the opposite direction. The annular skirt can 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 the radially expanded configuration, the outer portion of the skirt can tightly conform to the outer surface of the frame, and the inflow end of the frame can be axially spaced from the fold so as 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 can extend axially so as to at least partially fill the axially extending gap.

[0020] In certain embodiments, the valve structure can include a plurality of valve leaflets each having an inflow edge portion, and the inflow edge portion of the valve leaflets can define a undulating and curved waveform following a plurality of interconnected strut segments of the frame in the circumferential direction when the frame is in the radially expanded configuration.

[0021] In certain embodiments, the outer portion of the skirt can be axially longer than the inner portion of the skirt.

[0022] In certain embodiments, the outer portion of the skirt can be circumferentially stretched when the frame is in the expanded configuration.

[0023] In certain embodiments, the prosthetic valve can include a tether coupled to the skirt, the tether extending at an oblique angle with respect to the longitudinal axis of the frame such that the tether can apply a tension to the skirt to prevent the fold from moving inwardly of the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

[0024] Also disclosed herein is a method of implanting a patch valve mounted on a delivery device. The method may include delivering a patch valve in a radially compressed configuration to a target location, the patch valve comprising an annular frame and an annular skirt having a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. The method may further include expanding the patch valve to a radially expanded configuration such that an outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame moves axially away from the fold, thereby forming an axially extending gap between the frame and the fold.

[0025] In certain embodiments, the patch valve may further comprise a valve structure. The valve structure may comprise a plurality of valve tips each having an inflow edge portion, and the inflow edge portion of the valve tips may define a undulating and curved waveform following a plurality of interconnected strut segments of the frame along a circumferential direction when the frame is in the radially expanded configuration.

[0026] In certain embodiments, the outer portion of the skirt may be circumferentially stretched when the frame is in the expanded configuration.

[0027] In certain embodiments, when the frame is in the radially compressed configuration, the inflow end of the frame may axially extend to the fold so as to completely fill the axially extending gap.

[0028] In certain embodiments, the patch valve may comprise a tether coupled to the skirt. The tether may be configured to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

[0029] Further disclosed herein are embodiments of a patch valve comprising an annular frame and an annular skirt covering at least a portion of the outer surface of the frame. The annular frame can have an inlet end and an outlet end, and the frame can be radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The lower edge of the skirt can extend to cover the inlet end of the frame. The skirt can be attached to the frame by a plurality of stitches. The stitches can be positioned on a selected plurality of struts of the frame such that the stitches form a wavy stitch line with undulations. Each of the stitch lines can form an angle of about 45 degrees with the longitudinal axis of the frame when the frame is in the radially expanded configuration. The skirt can be woven from a first set of inelastic fibers oriented in a first direction and a second set of inelastic fibers oriented in a second direction. The first direction can be generally perpendicular to a second direction that can form an angle of about 45 degrees with the lower edge of the skirt. The skirt can be sized to fit tightly against the outer surface of the frame without slack when the frame is in the radially expanded configuration.

[0030] In some embodiments, the skirt can be folded around the inlet end of the frame such that the lower edge of the skirt defines a fold. When the frame is in the radially expanded configuration, the inlet 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 inlet end of the frame can move axially closer to the fold within the gap.

[0031] In some embodiments, when the frame is radially compressed, the skirt can undulate to form flaps folded between the wavy stitch lines.

[0032] In some embodiments, each flap can be folded over its adjacent flap circumferentially to maintain a small, contracted profile of the patch valve.

[0033] Certain embodiments of the present disclosure relate to a patch valve comprising an annular frame having an inlet end and an outlet end, at least one actuator mounted on the frame, and an annular skirt having a fold extending around the inlet 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 may be configured to radially expand or compress the frame between a radially compressed configuration and a radially expanded configuration. When the frame is in the radially expanded configuration, the outer portion of the skirt can fit tightly against the outer surface of the frame, and the inlet end of the frame can be axially spaced from the fold so as to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inlet end of the frame can extend axially so as to at least partially fill the axially extending gap.

[0034] In some embodiments, the at least one actuator can be one of a plurality of actuators mounted on the inner surface of the frame and equally spaced around the inner surface of the frame.

[0035] In some embodiments, the at least one actuator can comprise a first mooring portion attached to a first location on the frame, a second mooring portion fixed to a second location on the frame, and a rod extending through the first mooring portion and the second mooring portion. The second location can be closer to the inlet 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.

[0036] In some embodiments, the rod can comprise a male thread configured to mate and engage with a female thread of the second mooring portion.

[0037] In some embodiments, the first location can be at a junction between two overlapping struts of the frame, and the first mooring portion can be hingedly connected to the junction by a fastener.

[0038] In some embodiments, at least one actuator can comprise a rod that is at least partially received within a sleeve, and axial movement of the rod relative to the sleeve can cause radial expansion or compression of the frame.

[0039] In some embodiments, at least one actuator can comprise a locking mechanism configured to lock the frame in a radially expanded configuration.

[0040] In some embodiments, at least one actuator can comprise an attachment member configured to form a releasable connection with a corresponding actuator member of a delivery device such that the actuator member of the delivery device can apply a force to at least one actuator to radially compress or expand the frame.

[0041] In some embodiments, the patching valve can further comprise a valve structure positioned within the frame and configured to permit blood flow through the patching valve in one direction and to block blood flow in the opposite direction.

[0042] In some embodiments, the valve structure can comprise a plurality of valve tips each having an inflow edge portion, and the inflow edge portions of the valve tips can define a wavy shape that undulates and curves along the circumferential direction following a plurality of interconnected strut segments of the frame when the frame is in a radially expanded configuration.

[0043] In some embodiments, the outer portion of the skirt can be axially longer than the inner portion of the skirt.

[0044] In some embodiments, the outer portion of the skirt can have substantially the same axial length as the inner portion of the skirt.

[0045] In some embodiments, the outer portion of the skirt can be axially shorter than the inner portion of the skirt.

[0046] In some embodiments, the outer portion of the skirt can be circumferentially stretched when the frame is in an expanded configuration.

[0047] In some embodiments, the upper edge of the outer portion of the skirt can be generally straight before being attached to the frame.

[0048] In some embodiments, the upper edge of the outer portion of the skirt can be attached to the frame at a plurality of swivel joints formed by the overlapping struts of the frame.

[0049] In some embodiments, the upper edge of the outer portion of the skirt can have a wavy shape and be stitched along a row of strut sections of the frame.

[0050] In some embodiments, the patch valve can further include a tether coupled to the skirt, the tether extending at an oblique angle to the fold such that the tether applies a pull to the skirt to prevent the fold from moving inwardly of the frame when the frame is radially expanded from a compressed configuration to an expanded configuration.

[0051] In some embodiments, the oblique angle can be in the range from about 10° to about 80°. In some embodiments, the oblique angle can be in the range from about 30° to about 60°. In some embodiments, the oblique angle can be about 45°.

[0052] In some embodiments, the first end of the tether can be positioned at the outflow edge portion of the outer portion of the skirt, and the second end of the tether can be positioned adjacent to the fold.

[0053] In some embodiments, the tether can include a stitching that is sewn to the outer portion of the skirt using a running stitch.

[0054] In some embodiments, the tether can include an elastic material.

[0055] In some embodiments, the tether can be one of a plurality of tethers each forming an oblique angle to the fold.

[0056] Certain embodiments of the present disclosure relate to a patch valve comprising an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, an 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 coupled to the skirt to prevent the fold from moving radially inward when the frame expands radially from the compressed configuration to the expanded configuration. The skirt may be folded around the inflow end of the frame to define a fold between the inner portion and the outer portion. The skirt may be sized such that when the frame is in the expanded configuration, the outer portion of the skirt can conform to the outer surface of the frame, 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.

[0057] In some embodiments, the patch valve may further comprise a valve structure positioned within the frame and configured to permit blood flow through the patch valve in one direction and to block blood flow in the opposite direction.

[0058] In some embodiments, the valve structure can comprise a plurality of valve leaflets, each valve leaflet having an inflow edge portion, and the inflow edge portion of the valve leaflet can define a undulating shape.

[0059] In some embodiments, the inner portion of the skirt can have a undulating outflow edge that is sutured to the inflow edge portion of the valve leaflet.

[0060] In some embodiments, the outer portion of the skirt can be secured to a row of struts that define the outflow end of the frame.

[0061] In some embodiments, the outer portion of the skirt can be circumferentially stretched when the frame is in the expanded configuration.

[0062] In some embodiments, the skirt can comprise a non-elastic fabric.

[0063] In some embodiments, the fabric may include polyethylene terephthalate fibers.

[0064] In some embodiments, the polyethylene terephthalate fibers may have a thickness of about 20 denier.

[0065] In some embodiments, the polyethylene terephthalate fibers can have a fiber spacing in the range from about 155 fibers per inch to about 180 fibers per inch. In some embodiments, the polyethylene terephthalate fibers can have a fiber spacing of about 160 fibers per inch.

[0066] In some embodiments, the skirt can be woven from a first set of fibers oriented in a first direction and a second set of fibers oriented in a second direction, where neither the first direction nor the second direction is perpendicular to the fold.

[0067] In some embodiments, the first direction can be generally perpendicular to the second direction that forms an angle of about 45 degrees with respect to the fold.

[0068] In some embodiments, when the frame is in an extended configuration, the first set of fibers can extend generally parallel to the first set of struts of the frame, the second set of fibers can extend generally parallel to the second set of struts of the frame, and the second set of struts can overlap the first set of struts to form the joints of the frame.

[0069] In some embodiments, the tether can extend at an angle oblique to the fold and can be configured to apply a pull to the skirt when the frame is in an extended configuration.

[0070] In some embodiments, the oblique angle can be about 45°.

[0071] In some embodiments, the first end of the tether can be positioned at the outflow edge portion of the outer portion of the skirt, and the second end of the tether can be positioned adjacent to the fold.

[0072] In some embodiments, the tether can include stitches sewn to the outer portion of the skirt using a running stitch.

[0073] In some embodiments, the tether can include an elastic material.

[0074] Certain embodiments of the present disclosure also relate to a patch valve comprising an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and an annular outer skirt that covers at least a portion of the outer surface of the frame. When the frame is in the radially compressed configuration, a portion of the outer skirt can undulate to form a longitudinally extending folded flap.

[0075] In some embodiments, each flap can be further folded circumferentially to maintain a small, contracted profile of the patch valve.

[0076] In some embodiments, each flap can at least partially overlap an adjacent flap circumferentially.

[0077] In some embodiments, the outer skirt can be connected to the struts of the frame along a zigzag attachment line.

[0078] In some embodiments, the outer skirt can be connected to the struts of the frame by stitches along a zigzag attachment line.

[0079] In some embodiments, the outer skirt may not be connected to either the struts of the frame or other components of the patch valve at locations not along the zigzag attachment line.

[0080] In some embodiments, the outer skirt can be connected to the frame only along the zigzag attachment line.

[0081] In some embodiments, the patch valve can further include a plurality of valve tips, each valve tip having an inflow edge portion attached to a strut of the frame along a zigzag attachment line.

[0082] In some embodiments, the flap can be V-shaped.

[0083] In some embodiments, the patch valve can further include an annular inner skirt that covers at least a portion of the inner surface of the frame, and the outer skirt can be connected to the inner skirt via a fold that extends around the inflow end of the frame.

[0084] In some embodiments, when the frame is in a radially expanded configuration, the outer skirt can be configured to fit tightly against 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 in a radially compressed configuration, the inflow end of the frame can be configured to extend axially to at least partially fill the axially extending gap.

[0085] In some embodiments, when the frame is in a radially expanded configuration, the axial length of the gap can be in the range from about 4 mm to about 8 mm. In some embodiments, the axial length of the gap can be about 6 mm when the frame is in a radially expanded configuration.

[0086] In some embodiments, when the frame is in a radially compressed configuration, the inflow end of the frame can extend axially into the gap to completely fill the gap.

[0087] In some embodiments, when the frame is in a radially compressed configuration, the inner skirt can be folded inwards towards the interior of the frame.

[0088] In some embodiments, the patch valve may further include a tether coupled to the outer skirt and extending at an oblique angle to the fold such that as the frame radially expands from a compressed configuration to an expanded configuration, the tether applies a pull to the outer skirt to prevent the fold from moving inwardly of the frame.

[0089] In some embodiments, the tether may include a stitching stitched to the outer skirt using a running stitch.

[0090] In some embodiments, the tether may include an elastic material.

[0091] Certain embodiments of the present disclosure further relate to a method of assembling a patch valve. The method may include receiving an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and attaching a skirt to the frame such that the annular 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 may be folded around the inlet end of the frame to define a fold between the inner portion and the outer portion. The skirt may be sized such that when the frame is in the expanded configuration, the outer portion of the skirt can conform to the outer surface of the frame, the inlet 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 inlet end of the frame can move axially closer to the fold within the gap.

[0092] In some embodiments, attaching the annular skirt to the frame may include stitching an upper edge of the inner portion of the skirt to a selected row of strut sections of the frame from the inside of the frame.

[0093] In some embodiments, attaching the annular skirt to the frame may include stitching the outer portion of the skirt to a row of struts defining the outlet end of the frame.

[0094] In some embodiments, the method may further include attaching a valve structure to a frame. The valve structure may be configured to allow blood flow through the patch valve in one direction and block blood flow in the opposite direction.

[0095] In some embodiments, the valve structure can include a plurality of valve leaflets, each valve leaflet having an inflow edge portion. The inflow edge portion of the valve leaflet may define a undulating shape. The step of attaching the valve structure to the frame may include stitching the inflow edge portion of the valve leaflet to a row of interconnected strut segments of the frame along the circumferential direction, from the inside of the frame.

[0096] In some embodiments, the method may further include coupling a tether to the skirt at an oblique angle with respect to the fold to prevent the fold from moving to the inside of the frame when the frame expands radially from a compressed configuration to an expanded configuration.

[0097] Certain embodiments of the present disclosure relate further to a method including receiving a patch valve comprising an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and an annular skirt covering at least a portion of the outer surface of the frame; compressing the frame to a radially compressed configuration such that a portion of the skirt undulates to form a longitudinally extending folded flap; and folding the flap circumferentially.

[0098] In some embodiments, the skirt may be stitched to the struts of the frame along a zigzag attachment line.

[0099] In some embodiments, the patch valve can include a plurality of valve leaflets, each valve leaflet having an inflow edge portion that is attached to the struts of the frame along a zigzag attachment line.

[0100] In some embodiments, the skirt can cover at least a portion of the inner surface of the frame and form a fold around the inflow end of the frame.

[0101] In some embodiments, the skirt can be sized such that when the frame is in the expanded configuration, the inlet 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 inlet end of the frame can move axially closer to the fold within the gap.

[0102] In some embodiments, the patch valve may further include a tether coupled to the skirt at an angle oblique to the fold so as to prevent the fold from moving inwardly of the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

[0103] In some embodiments, the method may further include loading the patch valve into a sheath of a delivery device, inserting the patch valve into a patient, advancing the patch valve through the patient's vasculature to an implantation site, and radially expanding the patch valve at the implantation site.

[0104] In some embodiments, the step of radially expanding the patch valve can cause the flaps to unfold.

[0105] In some embodiments, when the frame is in the radially expanded configuration, the skirt can conform tightly to the outer surface of the frame.

[0106] The foregoing and other objects, features, and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings.

Brief Description of the Drawings

[0107]

Figure 1

Figure 2A

Figure 2B

Figure 2C

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DETAILED DESCRIPTION OF THE INVENTION

[0108] Figure 1 shows an exemplary prosthetic valve 10 according to one embodiment. In a specific embodiment, the prosthetic valve 10 can be implanted within the native aortic valve annulus, but can also be implanted at other locations within the heart, including within the native mitral valve, native pulmonary valve, and native tricuspid valve. The prosthetic valve 10 can comprise an annular stent or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 can also comprise a valve structure 18 coupled to and supported within the frame 12. The valve structure 18 is configured to regulate blood flow through the prosthetic valve 10 from the inflow end 14 to the outflow end 16.

[0109] The prosthetic valve 10 can further comprise one or more actuators 50 mounted on the inner surface of the frame 12 and equally spaced around the inner surface thereof. Each of the actuators 50 can be configured to form a releasable connection with one or more respective actuators of a delivery device, as further described hereinafter.

[0110] The valve structure 18 can comprise a leaflet assembly comprising one or more leaflets 20 made of, for example, a flexible material. The leaflets 20 can be made, in whole or in part, of a biological material, a biocompatible synthetic material, or other such material. Suitable biological materials can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 can be fixed to each other at their adjacent sides to form seams 22, and each of the seams 22 can be fixed to a respective actuator 50 or frame 12.

[0111] In the described embodiments, the valve structure 18 may comprise three valve tips 20 that may be arranged to collapse in a three-tip configuration. Each valve tip 20 may have an inlet edge portion 21. As shown in FIG. 1, when the frame 12 is in a radially expanded configuration, the inlet edge portion 21 of the valve tip 20 may define a wavy and curved waveform that follows or traces a plurality of interconnected strut segments of the frame 12 in the circumferential direction. The inlet edge of the valve tip may be referred to as a "wavy line". In some embodiments, the inlet edge portion 21 of the valve tip 20 may generally be stitched to the struts along the wavy line. By forming the valve tip 20 with this wavy shape, the stress on the valve tip 20 is reduced, which further improves the durability of the valve 10. Further, due to the waveform, the folds and corrugations in the bulge (the central region of each valve tip) of each valve tip 20 may cause premature hardening in those regions and may be eliminated or at least minimized. The wavy shape also reduces the amount of tissue material used to form the valve structure 18, thereby allowing for a smaller and more uniformly constricted profile at the inlet end 14 of the valve 10.

[0112] Further details regarding transcatheter prosthetic heart valves, including techniques by which a valve structure may be coupled to the frame 12 of the prosthetic valve 10, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and U.S. Patent Application No. 15 / 978,459, all of which are incorporated herein by reference in their entirety.

[0113] The prosthetic valve 10 may be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. FIGS. 2A - 2C show the bare (without valve tips or other components) frame 12 of the prosthetic valve 10 for the purpose of showing the expansion of the prosthetic valve 10 from a radially compressed configuration to a radially expanded configuration. FIG. 2A shows the frame 12 in a radially compressed configuration, FIG. 2B shows the frame 12 in an incompletely expanded configuration, and FIG. 2C shows the frame 12 in a fully radially expanded configuration.

[0114] In the illustrated embodiment, the patch valve 10 can be mechanically expanded from a radially compressed configuration to a radially expanded configuration. For example, the patch valve 10 can be expanded radially by applying an axial force (F) to the outflow end 16 toward the inflow end 14 while maintaining the inflow end 14 of the frame 12 in a fixed position. Alternatively, the patch valve 10 may be expanded by applying an axial force to the inflow end 14 while maintaining the outflow end 16 in a fixed position, or by applying opposite axial forces to the inflow end 14 and the outflow end 16, respectively.

[0115] In the illustrated embodiment, the expansion force and the compression force are applied to the frame by the actuator 50. Referring again to FIG. 1, each of the actuators 50 may include a screw or threaded rod 52, a first mooring portion in the form of a cylinder or sleeve 54, and a second mooring portion in the form of a threaded nut 56. The rod 52 extends through the sleeve 54 and the nut 56. The sleeve 54 can be fixed to the frame 12 with a fixture that forms a hinge at the joint between the two struts. Each actuator 50 is configured to increase the distance between the mounting locations of the respective sleeves 54 and nuts 56, thereby lengthening the frame 12 axially and compressing it radially, and to decrease the distance between the mounting locations of the respective sleeves 54 and nuts 56, thereby shortening the frame 12 axially and expanding it radially.

[0116] For example, each rod 52 may have a male thread that engages a female thread of the nut 56 such that rotation of the rod causes a corresponding axial movement of the nut 56 toward or away from the sleeve 54 (depending on the direction of rotation of the rod 52). This moves the hinges supporting the sleeve 54 and the nut 56 closer together or farther apart from each other, depending on the direction of rotation of the rod 52, to expand the frame radially or to compress the frame radially.

[0117] In other embodiments, the actuator 50 may be a reciprocating actuator configured to apply an axially directed force to the frame to create radial expansion and compression of the frame. For example, the rod 52 of each actuator can be axially fixed relative to the nut 56 and can slide relative to the sleeve 54. Thus, in this approach, moving the rod 52 distally relative to the sleeve 54 and / or moving the sleeve 54 proximally relative to the rod 52 compresses the frame radially. Conversely, moving the rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the rod 52 expands the frame radially.

[0118] When a reciprocating actuator is used, the repair valve may also include one or more locking mechanisms to hold the frame in the expanded state. The locking mechanism can be a separate component mounted on the frame away from the actuator or can be a component that is subordinate to the actuator itself.

[0119] Each rod 52 may include a mounting member 58 along the proximal end portion of the rod 52 configured to form a releasable connection with the corresponding actuator of the delivery device. The actuator of the delivery device can apply a force to the rod to radially compress or expand the repair valve 10. The mounting member 58 in the illustrated configuration includes a notch 60 and a protrusion 62 that can engage a corresponding protrusion of the actuator of the delivery device.

[0120] In the illustrated embodiment, the prosthetic valve 10 includes three such actuators 50, although a greater or lesser number of actuators may be used in other embodiments. The valve tip 20 may have a seam attachment member 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. Patent Application Publication No. 2018 / 0153689), and 15 / 978,459, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed patent applications can be incorporated into any of the prosthetic valves disclosed herein. Further, any of the delivery devices disclosed in the previously filed patent applications can be used to deliver and implant any of the prosthetic valves disclosed herein.

[0121] The frame 12 can be made from any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloy, or a nickel-titanium alloy ( "NiTi"), such as nitinol. As shown, the frame 12 can comprise a plurality of interconnected struts 24 arranged in a lattice-type pattern. The struts 24 are shown as being positioned obliquely, or offset at an angle with respect to the longitudinal axis 26 of the prosthetic valve 10 and radially offset from its longitudinal axis 26 when the prosthetic valve 10 is in an expanded configuration. In other implementations, the struts 24 may be offset by a different amount than depicted in FIGS. 2B and 2C, or some or all of the struts 24 may be positioned parallel to the longitudinal axis 26 of the prosthetic valve 10.

[0122] In the described embodiments, the struts 24 are pivotally coupled to one another at one or more swivel joints along the length of each strut. For example, in the illustrated configuration, each of the struts 24 can be formed with an opening at opposite ends of the strut and openings spaced along the length of the strut. Each hinge can be formed where the struts 24 overlap one another via a fastener, such as a rivet or pin 28 that extends through the openings. The hinge can allow the struts 24 to pivot relative to one another as the frame 12 expands or compresses radially, such as during the assembly, preparation, or implantation of the patch valve 10.

[0123] In the described embodiments, the struts 24 are arranged in five columns (I, II, III, IV, and V) from the inlet end 14 to the outlet end 16. Each column is defined by strut segments that extend in a zigzag pattern between adjacent surrounding columns of hinges 28. For example, the first column I is defined by a strut segment 25 that extends between the first column of hinges 28a at the inlet end of the frame and an adjacent column of hinges 28b. In other embodiments, the segments of the struts 24 can be arranged in different numbered columns.

[0124] In some embodiments, the frame 12 can be constructed by forming the individual components (e.g., struts and frame fasteners) and then mechanically assembling and connecting the individual components. In other embodiments, the struts 24 are not coupled to each other at respective hinges and are pivotable or bendable relative to each other to allow for radial expansion and contraction of the frame 12. For example, the frame 12 can be formed from a single piece of material (e.g., a metal tube) (e.g., via laser cutting, electroforming, or physical vapor deposition). Further details regarding the construction of the frame and the occluder valve are described in U.S. Patent Applications Nos. 15 / 831,197, 15 / 995,528, and 62 / 548,855, all of which are incorporated herein by reference. Additional examples of expandable occluder valves that can be used in the delivery devices disclosed herein are described in U.S. Patent Application Publications Nos. 2015 / 0135506 and 2014 / 0296962, which are incorporated herein by reference.

[0125] In other embodiments (not shown), the frame can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, cobalt-chromium alloys, etc.) or self-expanding materials (e.g., nitinol) that are known in the art. When constructed from a plastically expandable material, the frame (and thus the valve) can be compressed in a radially compressed configuration in the delivery device and then expanded by an inflatable balloon or other suitable expansion mechanism inside the patient. When constructed from a self-expanding material, the frame (and thus the valve) can be compressed into a radially compressed configuration and held in the compressed configuration by insertion into a sheath of the delivery device or an equivalent mechanism. Inside the body, the valve can be advanced from the delivery sheath, thereby expanding the valve to its functional size.

[0126] As shown in FIGS. 3-7, the occluder valve 10 can further include an annular skirt 30 attached to the frame 12. A plan view of the skirt 30 is shown in FIG. 8.

[0127] In the illustrated embodiment, the skirt 30 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 inlet end 14 of the frame 12 and then along the outer surface of the frame so as 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 can cover at least a portion of the inner surface of the frame 12, and the outer portion 34 can cover at least a portion of the outer surface of the frame 12.

[0128] The inner portion 32 of the skirt 30 can function as a sealing member to prevent or reduce leakage beside the valve and to moor the valve tip 20 to the frame 12. The outer portion 34 of the skirt 30 can function as a sealing member for the prosthetic valve 10 by applying and sealing against the tissue of the native valve annulus and helping to reduce leakage beside the valve from the prosthetic valve 10.

[0129] As best shown in FIG. 8, the upper edge 38 of the inner portion 32 (which is the outflow edge of the inner portion in the illustrated embodiment) may have a wavy shape generally following the shape of a selected row of the strut section 25 of the frame 12 when the frame 12 is in the expanded configuration. In this approach, the upper edge 38 of the inner portion 32 can be tightly fixed to a selected row of the strut section 25 by suturing. For example, in some embodiments, the upper edge 38 of the inner portion 32 can be sutured to row II of the strut section. In other embodiments, the upper edge 38 of the inner portion 32 can be sutured to row III of the strut section.

[0130] In a specific embodiment, the suturing used to fix the upper edge 38 extends only around the strut section aligned with a wavy line (the line following the inflow edge portion 21 of the valve tip) defined by the valve tip 20. In some embodiments, the upper edge 38 of the inner portion 32 is "sandwiched" between the frame 12 and the valve tip 20. For example, the inflow edge portion 21 of the valve tip can overlap a portion of the inner surface of the inner portion 32 along the upper edge 38, and the valve tip can be fixed to the inner portion 32 by sutures extending through the inner surface of the inner portion 32.

[0131] In the described embodiment, the upper edge 40 of the outer portion 34 (which is the outflow edge of the outer portion in the illustrated embodiment) is generally straight and can be attached to the frame at the swivel joint just below the column V of the strut section (see, for example, FIG. 4). In an alternative embodiment (not shown), the upper edge 40 of the outer portion 34 may have a undulating shape (similar to the upper edge of the inner portion 32) so that it can be stitched along the strut section of a selected column (e.g., column V of the strut section).

[0132] In the described embodiment, the outer portion 34 of the skirt 30 is axially longer than the inner portion 32 of the skirt 30, that is, 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.

[0133] Although not shown, in an alternative embodiment, the axial length of the outer portion 34 can be the same as 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, that is, 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.

[0134] As described above, to deploy the patch valve 10, the frame 12 is radially expanded to a larger diameter (i.e., the deployment diameter). The deployment diameter can be within the operating range of diameters defined between a minimum deployment diameter and a maximum deployment diameter. In one exemplary but non-limiting embodiment, the minimum deployment diameter is about 26 mm and the maximum deployment diameter is about 29 mm.

[0135] In a specific embodiment, when the frame 12 is radially expanded (see, for example, FIGS. 4 - 5), the outer portion 34 of the skirt 30 can be slightly stretched circumferentially. In a specific embodiment, the skirt 30 can be sized so that when the frame 12 is expanded to a diameter within the operating range, the outer portion 34 of the skirt 30 is stretched to fit tightly or precisely against the outer surface of the frame 12, that is, no slack is formed in the outer portion 34 around the perimeter of the frame 12.

[0136] For example, during the assembly of the prosthetic valve 10, the skirt 30 can be sutured to the frame 12 when it is expanded to its minimum deployment diameter. The skirt 30 can be sized such that when the frame 12 is expanded to its minimum deployment diameter, the outer portion 34 fits tightly against the outer surface of the frame 12 without any radial slack. Such a tight fit of the skirt 30 to the outer surface of the frame 12 can prevent the skirt 30 from protruding through the compartments of the frame, thereby preventing wear of the valve tip 20.

[0137] When the frame 12 is radially expanded to a larger diameter within the operating range of the deployment diameter, the outer portion 34 of the skirt 30 can further tighten on the frame 12. Thus, in certain embodiments, it can be ensured that the outer portion 34 has no radial slack when the frame 12 is expanded to any diameter within the operating range. In some embodiments, the skirt 30 can be cut to a smaller size and mounted on the frame 12 (at its minimum deployment diameter) in a somewhat circumferentially stretched state to ensure that the outer portion 34 fits tightly around the frame 12 at its minimum deployment diameter.

[0138] In other embodiments, the skirt 30 can be sized such that when the frame 12 is expanded to its minimum deployment diameter, there is no elongation of the skirt in any direction, no radial slack, and it fits snugly around the frame. When the frame is radially expanded to a larger diameter within the operating range, the skirt 30 can stretch slightly and tighten around the frame.

[0139] In some embodiments, the patch valve may have only one deployment diameter. In such cases, the skirt 30 can be sized so that when the frame 12 expands to the deployment diameter, there is no elongation of the skirt in any direction, no radial slack, and it fits snugly around the frame. In other embodiments, the skirt 30 can be sized to be slightly elongated circumferentially when the frame expands to the deployment diameter.

[0140] Also, when the frame 12 expands radially, the inlet end 14 of the frame 12 can be axially spaced from the fold 36 to form an axially extending gap 42 between the inlet end 14 of the frame 12 and the fold 36 (see, for example, FIG. 5). In some embodiments, the gap 42 can have a length (L) in the range from about 4 mm to about 8 mm. In a specific embodiment, the length L of the gap 42 can be about 6 mm.

[0141] When the frame 12 is radially compressed while collapsing (see, for example, FIGS. 6 - 7), the inlet 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 inlet end 14 of the frame 12 can extend to the fold 36 such that the frame 12 completely fills the gap 42. Also, when the frame 12 is in the radially compressed configuration, the outer portion 34 of the skirt 30 can form longitudinal pleats as shown in FIG. 3. On the other hand, the inner portion 32 of the skirt 30 can fold inwards towards the inside of the frame 12.

[0142] 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 a plain weave design with PET fibers or yarns in both the warp direction (longitudinal direction) and the weft direction (circumferential direction). In a specific embodiment, the skirt can be assembled to 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 alternative embodiment, the skirt can be assembled to 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.

[0143] In other embodiments, the skirt 30 may be elongated at a specific angle in both the radial and axial directions even if it is still woven using inelastic fibers. Such pseudo-elasticity can be achieved, for example, by orienting the fibers at an angle with respect to the height of the skirt and / or by increasing the spacing between the fibers. For example, as shown in FIG. 8, the skirt 30 can be woven from a first set of fibers (or yarns or plies) extending in a first direction 44 and a second set of fibers (or yarns or plies) extending in a second direction 46, where neither the first direction 44 nor the second direction 46 is perpendicular to the fold 36.

[0144] In a specific embodiment, 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 and 75 degrees, or between 30 and 60 degrees) with respect to the fold 36. In a specific embodiment, the first direction 44 extends parallel or substantially parallel to the outer strut 24a, and the second direction 46 extends parallel or substantially parallel to the inner strut 24b when the frame 12 is in its radially expanded state.

[0145] In some embodiments, the spacing between woven fibers (or yarns or plies) can be increased to facilitate expansion of the skirt 30 in both the radial and axial directions. For example, for a PET skirt 30 formed from 20 denier yarns, the yarn density can be about 15% to about 30% less than that of a conventional PET skirt. In some examples, the yarn spacing in the skirt 30 can be from about 155 to about 180 yarns per inch, such as about 160 yarns per inch, whereas in a conventional PET skirt, the yarn spacing can be from about 217 to about 247 yarns per inch.

[0146] In some embodiments, the fibers can be oriented to be parallel or substantially parallel to the struts and / or, by increasing the spacing between the fibers, the skirt 30 can be lengthened by up to about 40% in the axial and / or circumferential directions. For example, in some embodiments, rotation of the fibers and / or an increase in the spacing between the fibers can lengthen the skirt 30 from a minimum deployed diameter to a maximum deployed diameter in the circumferential direction.

[0147] In the illustrated embodiment where only the upper edge 40 of the outer portion 34 of the skirt 30 is attached to the frame 12, the outer portion 34 of the skirt 30 does not restrict the axial expansion of the frame 12 when the frame is radially compressed. Thus, the frame 12 is free to move axially toward the fold 36 within a gap 42 that extends axially while contracting. As a result, a relatively small contracting force is required to contract the relief valve 10, and excessive expansion of the skirt 30 can be avoided.

[0148] In some embodiments, a tether 48 can be coupled to the skirt 30 to prevent the fold 36 from moving inwardly of the frame 12 when the frame 12 expands radially from a compressed configuration to an expanded configuration.

[0149] For example, the skirt 30 may include a tether 48 that diagonally extends from a first end 48a to a second end 48b positioned at or near the fold 36 such that the tether 48 forms an oblique angle with respect to the fold 36 (see, e.g., FIG. 3). In some embodiments, the angle between the tether 48 and the fold 36 may range from about 10° to about 80°. In some embodiments, the angle between the tether 48 and the fold 36 may range from about 30° to about 60°. In one particular embodiment, the angle between the tether 48 and the fold 36 may be about 45°.

[0150] In a specific embodiment, the first end 48a may be positioned at the upper edge 40 of the outer portion 34. In other embodiments, the first end 48a may be spaced from the upper edge 40. In an alternative embodiment, the first end 48a may be attached to an upper portion of the frame 12. In some embodiments (not shown), two or more tethers 48 may be coupled to the skirt 30, and each tether 48 extends at an oblique angle with respect to the fold 36.

[0151] In some embodiments, the tether 48 may be formed from a stitching that is sewn to the outer portion 34 of the skirt, for example, using a running stitch as depicted in FIGS. 3 and 4. Due to the running stitch, the length of the stitching may be longer than the distance advanced by the stitching such that the stitching line can be lengthened when stretched. In this approach, the stitching can function similar to a coil that returns to its original length after being stretched. In other embodiments, the tether 48 may be formed from an elastic material (e.g., elastic fabric) that can be longitudinally stretched when a pull is applied along its length and return to its original length when the pull is removed.

[0152] Thus, when the frame 12 expands radially from the compressed configuration to the expanded configuration, the tether 48 can be stretched in the longitudinal direction of the tether due to the radial expansion of the outer portion 34 of the skirt. As a result, the tether 48 is relatively taut and can hold the fold 36 in place against the blood flow force. Thus, the tether 48 can prevent the fold 36 from moving inside the frame 12 when the frame 12 is in the expanded configuration, which otherwise could impede the inflow of fluid through the valve 10. When the frame 12 is compressed radially, the tether 48 can return to its original length.

[0153] The above-described patch valve 10 can be mounted on a delivery device and delivered to a target location within a patient. Various embodiments of delivery devices and methods for delivering patch valves are 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 by reference.

[0154] To mount the patch valve 10 on a delivery device, the patch valve 10 can be constricted onto the shaft of the delivery device. During constriction, while the diameter of the frame 12 decreases, the axial length of the frame 12 increases. By using a fabric with angled fibers and / or increased spacing between the fibers, the skirt 30 can be made axially longer. Further, since the frame 12 is not restricted by the outer portion 34 of the skirt 30, the frame 12 can freely lengthen axially, and the inflow end 14 of the frame 12 can extend into the gap 42 during constriction. As described above, when the frame 12 is compressed radially, the outer portion 34 of the skirt 30 can form longitudinal pleats, and the inner portion 32 of the skirt 30 can fold inward.

[0155] After being delivered to the target location, the patch valve 10 can be expanded until the diameter of the frame 12 is within its operating range. During expansion, while the diameter of the frame 12 increases, the axial length of the frame 12 decreases. When the patch valve 10 is in the radially expanded configuration, the outer portion 34 of the skirt 30 in a specific embodiment can be circumferentially extended so as to tightly fit the outer surface of the frame 12 without radial slack. During that time, the inlet 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 coupled to the skirt 30 to prevent the fold 36 from moving inside the frame 12 during valve expansion.

[0156] FIG. 9 shows a patch valve 110 according to another embodiment. The patch 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 patch valve 10, the patch valve 110 can include a valve structure 118 attached to the frame 112, and the valve structure 118 can include a plurality of valve tips 120 having a wave shape (three valve tips are shown in FIG. 9).

[0157] The patch 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, the lower edge 136 of the skirt 130 (the inlet edge in the illustrated embodiment) can extend from the inlet end 114 of the frame 112, while the upper edge 140 of the skirt 130 (the outlet edge in the illustrated embodiment) can be offset from the outlet end 116 of the frame 112. In the described embodiment, the frame 112 has five columns of strut sections, and only the column of strut sections that defines the outlet end 116 is not covered by the skirt 130. In other embodiments, the skirt 130 can be sized to cover a portion of the outer surface of the frame that is different from that shown in FIG. 9, or can extend across the entire outer surface of the frame 112. In some embodiments, the skirt 130 can be folded around the inlet end 114 of the frame to form a gap similar to the axially extending gap 42 depicted in FIG. 5.

[0158] As shown in FIG. 9, the skirt 130 can be stitched to the post section 124 of the frame 112 along a wavy line 121 defined by the inflow edge of the valve tip 120. In the illustrated embodiment, the wavy line 121 is a zigzag attachment line for the skirt 130 and the inflow edge of the valve tip 120. In some embodiments, the stitching 122 can be positioned to wrap around a plurality of posts such that the stitching 122 is positioned along a path generally following the wavy line 121. As shown in FIG. 9, each section of the wavy line 121 (the section where the inflow edge of the valve tip 120 attaches to the frame 112) forms an angle of approximately 45 degrees with the longitudinal axis 126 of the frame 112 when the frame 112 is in the expanded configuration. During contraction of the frame 112, the post sections along the wavy line 121 move inwardly. Thus, those stitches 122 along the wavy line 121 do not impose stress on the skirt 130. In some embodiments, some of the stitches 122 along the wavy line 121 are configured to be able to slide along the post. Such sliding stitches can further reduce the stress on the skirt 130 when the frame 112 is radially compressed or expanded.

[0159] In a specific embodiment, the outer skirt 130 is connected to the frame only along the attachment line 121, i.e., the outer skirt is not connected to either the posts of the frame or other components of the patch valve at locations not along the attachment line 121.

[0160] In some embodiments, the outer skirt 130 is connected to the posts of the frame along the attachment line 121, but the inflow edge portion of the valve tip 120 need not be connected to the frame along the attachment line 121.

[0161] Figure 10 shows a prosthetic valve 210 according to another embodiment. Similar to the valve 110 described above, the valve 210 includes a radially compressible and expandable frame 212 and an outer skirt 230 that covers at least a portion of the outer surface of the frame 212. Like the valve 110, the skirt 230 can be fixed to the frame 212 by stitching 222 along a predetermined wavy line 221 (a zigzag attachment line for the skirt in the illustrated embodiment). The valve structure is not shown in Figure 10 so that the stitching line 221 behind the frame 212 can be clearly seen. The frame 212 of the illustrated embodiment has four columns of strut sections, and two columns of the strut sections closest to the outflow end 216 are not covered by the skirt 230.

[0162] Similar to the skirt 30 described above, the fabric of the skirt 130 or 230 can be rotated (e.g., 45 degrees) and woven using inelastic fibers with an optionally increased spacing between the fibers, so that the skirt 130 or 230 can accept a certain degree of elongation in both the radial and axial directions. Similarly, the skirt 130 or 230 can be sized to fit tightly against the outer surface of the respective frame 112 or 212 without looseness when the respective frame 112 or 212 is expanded to its minimum operating diameter.

[0163] Figure 12A shows that when the frame 112 is compressed radially, a portion of the skirt 130 can undulate to form a folded V-shaped flap 150 that extends longitudinally between adjacent regions of the wavy stitching line 121. In some embodiments, each flap 150 can be further folded circumferentially to maintain the small, contracted profile of the valve 110. As shown, depending on the number and size of each flap, each flap 150 can partially overlap adjacent flaps circumferentially. For example, Figures 12B - 12C show that the flap 150 is folded clockwise (when viewed from the outflow end), but it should be understood that the flap 150 can be folded counterclockwise.

[0164] Similarly, when the frame 212 is compressed radially, as shown in FIG. 11, the skirt 230 can undulate to form a folded V-shaped flap 250 that extends longitudinally between adjacent regions of the suture line 221. To maintain a small, contracted profile, it may be desirable to implement the patterned folds of the flap 250 by winding the flap 250 circumferentially, similar to the embodiments shown in FIGS. 12B - 12C.

[0165] In the illustrated embodiment, the inflow and outflow edges of the skirt 130 and skirt 230 are not connected to the frame of the prosthetic valve or other components except along the attachment lines 121, 221, which alternate with a plurality of second V-shaped flaps that open toward the inflow end of the prosthetic valve around the circumferential perimeter of the frame (as best shown in FIG. 11) to form a plurality of first V-shaped flaps that open toward the outflow end of the prosthetic valve.

[0166] General Considerations The disclosed embodiments can be adapted to deliver a prosthetic device and implant the prosthetic device at any of the native valve annuli of the heart (e.g., pulmonary valve annulus, mitral valve annulus, and tricuspid valve annulus) and can be used with any of a variety of delivery techniques (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0167] For the purposes of this description, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limited in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to their particular aspects, features, or combinations, and the disclosed embodiments do not require that one or more particular advantages exist or that problems be solved. The techniques from any example can be combined with the techniques described in any one or more of the other examples. Considering the many possible embodiments to which the principles of the disclosed techniques can be applied, it should be recognized that the illustrated embodiments are merely representative examples and should not be taken as limiting the scope of the disclosed techniques.

[0168] Some operations of the disclosed embodiments are described in a particular sequential order for convenience of presentation, but it should be understood that this description of the technique encompasses rearrangement if the particular order is not required by explicit language stated later. For example, the operations described sequentially may, in some cases, be rearranged or performed in parallel. Further, for simplicity, the attached figures may not show the various ways in which the disclosed method can be used in combination with other methods. Also, this description may use terms such as "provide" or "achieve" to describe the disclosed method. These terms are a high-level abstraction of the actual operations performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily recognizable by those skilled in the art.

[0169] 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. Also, the term "comprising" means "including". Further, the terms "coupled" and "connected" generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or connected, and, in the absence of specific contrary language, do not exclude the presence of intermediate elements between the coupled or related items.

[0170] Directions and other relative references (e.g., inside, outside, above, below, etc.) may be used in this specification to facilitate the detailed description of the drawings and principles, but are not intended to be limiting. For example, specific terms such as "inside", "outside", "above", "below", "inner", "outer", etc. may be used. Such terms, when applicable, are used to provide some clarity in the description when dealing with relative relationships, specifically with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the "upper" portion can simply become the "lower" portion by turning the object over. Nevertheless, it is still the same portion and the object remains the same. As used herein, "and / or" means "and" or "or", or both "and" and "or".

[0171] It should be recognized that, considering the many possible embodiments to which the principles of the disclosed invention can be applied, the illustrated embodiments are merely preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. The subject matter of the invention is also provided by the following clauses. [Claim 1] A patch valve, an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, A valve structure positioned within the frame and configured to permit blood flow through the patch valve in one direction and to block blood flow in the opposite direction. An 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, the skirt being folded around the inflow end of the frame so as to define a fold between the inner portion and the outer portion. Comprising The skirt is sized such 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 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 within the gap. A patch valve. [Item 2] The outer portion of the skirt is fixed to a row of struts defining the outflow end of the frame. The patch valve according to Item 1. [Item 3] The outer portion of the skirt is circumferentially stretched when the frame is in the expanded configuration. The patch valve according to Item 1 or 2. [Item 4] The skirt comprises a non-elastic fabric. The patch valve according to any one of Items 1 to 3. [Item 5] The fabric is woven using polyethylene terephthalate fibers in both the warp direction and the weft direction. The patch valve according to Item 4. [Item 6] 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 the first direction nor the second direction being perpendicular to the fold. The patch valve according to any one of Items 1 to 5. [Item 7] The patch valve according to claim 6, wherein the first direction is generally perpendicular to the second direction that forms an angle of about 45 degrees with respect to the fold. [Claim 8] The patch valve according to any one of claims 1 to 7, wherein the valve structure includes a plurality of valve tips, each valve tip has an inflow edge portion, and the inflow edge portion of the valve tip defines a undulating shape. [Claim 9] The patch valve according to claim 8, wherein the inner portion of the skirt has a undulating outflow edge that is stitched to the inflow edge portion of the valve tip. [Claim 10] The patch valve according to any one of claims 1 to 9, further comprising a tether coupled to the skirt, the tether being configured to prevent the fold from moving inside the frame when the frame expands radially from the compressed configuration to the expanded configuration. [Claim 11] A patch valve, an annular frame having an inflow end and an outflow end and being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, a valve structure positioned within the frame and configured to permit blood flow through the patch valve in one direction and to block blood flow in the opposite direction, an annular skirt having 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, comprising, when the frame is in the radially expanded configuration, an outer portion of the skirt fits tightly against 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 in the radially compressed configuration, the inflow end of the frame extends axially to at least partially fill the axially extending gap, the patch valve. [Claim 12] The valve structure includes a plurality of valve tips each having an inflow edge portion, and the inflow edge portion of the valve tip defines a wavy shape that undulates and curves following a plurality of strut sections interconnected in the circumferential direction of the frame when the frame is in the radially expanded configuration. The patch valve according to claim 11. [Claim 13] The outer portion of the skirt is axially longer than the inner portion of the skirt. The patch valve according to claim 11 or 12. [Claim 14] The outer portion of the skirt is extended in the circumferential direction when the frame is in the expanded configuration. The patch valve according to any one of claims 11 to 13. [Claim 15] A tether coupled to the skirt, the tether extending at an oblique angle with respect to the longitudinal axis of the frame so as to apply a tensile force to the skirt to prevent the fold from moving inside the frame when the frame expands radially from the compressed configuration to the expanded configuration. The patch valve according to any one of claims 11 to 14, further comprising a tether. [Claim 16] A method of implanting a patch valve mounted on a delivery device, Delivering the patch valve in a radially compressed configuration to a target location, the patch valve comprising an annular frame and an annular skirt having 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. A step, Expanding the patch valve to a radially expanded configuration such that the outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame moves axially away from the fold, thereby forming an axially extending gap between the frame and the fold. A step and A method including. [Claim 17] The patch valve further comprises a valve structure having a plurality of valve tips, each valve tip having an inflow edge portion, and the inflow edge portion of the valve tip defines a wavy shape that undulates and curves following a plurality of strut segments interconnected in the circumferential direction of the frame when the frame is in the radially expanded configuration, the method according to claim 16. [Claim 18] The outer portion of the skirt is circumferentially extended when the frame is in the expanded configuration, the method according to claim 16 or 17. [Claim 19] When the frame is in the radially compressed configuration, the inflow end of the frame axially extends to the fold so as to completely fill the axially extending gap, the method according to any one of claims 16 to 18. [Claim 20] The patch valve further comprises a tether coupled to the skirt, the tether being configured to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration, the method according to any one of claims 16 to 19. [Claim 21] An annular frame having an inflow end and an outflow end and being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, An annular skirt covering at least a portion of the outer surface of the frame, the lower edge of the skirt extending to cover the inflow end of the frame, an annular skirt comprising The skirt is attached to the frame by a plurality of stitches, the stitches being positioned on a selected plurality of struts of the frame so as to form a wavy stitch line, each of the stitch lines forming an angle of about 45 degrees with respect to the longitudinal axis of the frame when the frame is in the radially expanded configuration, The skirt is woven from a first set of inelastic fibers oriented in a first direction and a second set of inelastic fibers oriented in a second direction, the first direction being generally perpendicular to the second direction that forms an angle of about 45 degrees with respect to the lower edge of the skirt, The skirt is a patch valve sized to fit tightly against the outer surface of the frame without slack when the frame is in the radially expanded configuration. [Item 22] The skirt is folded around the inlet end of the frame such that the lower edge of the skirt defines a fold, and when the frame is in the radially expanded configuration, the inlet 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 inlet end of the frame moves axially closer to the fold within the gap, the patch valve according to Item 21. [Item 23] The skirt undulates to form flaps folded between the corrugated seams when the frame is radially compressed, the patch valve according to Item 21. [Item 24] Each flap is folded over its adjacent flap circumferentially to maintain the small, contracted profile of the patch valve, the patch valve according to Item 23. [Item 25] An annular frame having an inlet end and an outlet end, At least one actuator mounted on the frame, the actuator configured to radially expand or compress the frame between a radially compressed configuration and a radially expanded configuration, An annular skirt having a fold extending around the inlet 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 comprising When the frame is in the radially expanded configuration, the outer portion of the skirt fits tightly against the outer surface of the frame, and the inlet 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 in the radially compressed configuration, the inlet end of the frame extends axially to at least partially fill the axially extending gap, a patch valve. [Item 26] The at least one actuator is one of a plurality of actuators mounted on the inner surface of the frame and equally spaced around the inner surface of the frame, the repair valve according to item 25. [Item 27] The at least one actuator includes a first mooring portion attached to a first location of the frame, a second mooring portion fixed to a second location of the frame, and a rod extending through the first mooring portion and the second mooring portion, the second location being closer to the inlet end of the frame than the first location, the rod being configured to increase or decrease the distance between the first location and the second location so as to radially compress or expand the frame, the repair valve according to item 25 or 26. [Item 28] The rod of the repair valve according to item 27 includes a male thread configured to fit and engage with a female thread of the second mooring portion. [Item 29] The first location is a joint between two overlapping struts of the frame, and the first mooring portion is hingedly connected to the joint by a fastener, the repair valve according to item 27 or 28. [Item 30] The at least one actuator includes a rod at least partially received in a sleeve, axial movement of the rod relative to the sleeve causing radial expansion or compression of the frame, the repair valve according to item 25 or 26. [Item 31] The at least one actuator of the repair valve according to item 30 includes a locking mechanism configured to lock the frame in the radially expanded configuration. [Item 32] The at least one actuator of the repair valve according to any one of items 25 to 31 includes a mounting member configured to form a releasable connection with a corresponding actuating member of the delivery device so that the actuating member of the delivery device can apply a force to the at least one actuator to radially compress or expand the frame. [Item 33] The patch valve according to any one of Items 25 to 32, further comprising a valve structure positioned within the frame and configured to allow blood flow through the patch valve in one direction and to block blood flow in the opposite direction. [Item 34] The patch valve according to Item 33, wherein the valve structure includes a plurality of valve tips each having an inflow edge portion, and the inflow edge portion of the valve tip defines a wavy shape that undulates and curves along a plurality of axially interconnected strut segments of the frame when the frame is in the radially expanded configuration. [Item 35] The patch valve according to any one of Items 25 to 34, wherein an outer portion of the skirt is axially longer than an inner portion of the skirt. [Item 36] The patch valve according to any one of Items 25 to 34, wherein an outer portion of the skirt has substantially the same axial length as an inner portion of the skirt. [Item 37] The patch valve according to any one of Items 25 to 34, wherein an outer portion of the skirt is axially shorter than an inner portion of the skirt. [Item 38] The patch valve according to any one of Items 25 to 37, wherein an outer portion of the skirt is circumferentially stretched when the frame is in the expanded configuration. [Item 39] The patch valve according to Item 38, wherein an upper edge of the outer portion of the skirt is generally straight before being attached to the frame. [Item 40] The patch valve according to Item 39, wherein the upper edge of the outer portion of the skirt is attached to the frame at a plurality of swivel joints formed by overlapping struts of the frame. [Item 41] The patch valve according to Item 38, wherein an upper edge of the outer portion of the skirt has a wavy shape and is stitched along a row of strut segments of the frame. [Item 42] A tether coupled to the skirt, the tether extending at an oblique angle with respect to the fold so as to apply a pull to the skirt to prevent the fold from moving inside the frame when the frame expands radially from the compressed configuration to the expanded configuration. The patch valve according to any one of paragraphs 25 to 41, further comprising a tether. [Paragraph 43] The patch valve according to paragraph 42, wherein the oblique angle is in the range of about 10° to about 80°. [Paragraph 44] The patch valve according to paragraph 43, wherein the oblique angle is in the range of about 30° to about 60°. [Paragraph 45] The patch valve according to paragraph 44, wherein the oblique angle is about 45°. [Paragraph 46] The patch valve according to any one of paragraphs 42 to 45, wherein a first end of the tether is positioned at an outflow edge portion of the outer portion of the skirt, and a second end of the tether is positioned adjacent to the fold. [Paragraph 47] The patch valve according to any one of paragraphs 42 to 46, wherein the tether comprises a stitching stitched to the outer portion of the skirt using a running stitch. [Paragraph 48] The patch valve according to any one of paragraphs 42 to 47, wherein the tether comprises an elastic material. [Paragraph 49] The patch valve according to any one of paragraphs 42 to 48, wherein the tether is one of a plurality of tethers each forming an oblique angle with respect to the fold. [Paragraph 50] An annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, An 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, the skirt being folded around the inflow end of the frame so as to define a fold between the inner portion and the outer portion. An annular skirt, A tether coupled to the skirt to prevent the fold from moving inside the frame when the frame expands radially from the compressed configuration to the expanded configuration and comprising The skirt is sized such that when the frame is in the expanded configuration, an outer portion of the skirt conforms to an outer surface of the frame, an inlet 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 inlet end of the frame moves axially closer to the fold within the gap, a patch valve. [Item 51] The patch valve according to item 50, further comprising a valve structure positioned within the frame and configured to permit blood flow through the patch valve in one direction and to block blood flow in the opposite direction. [Item 52] The patch valve according to item 51, wherein the valve structure comprises a plurality of valve tips, each valve tip having an inlet edge portion, and the inlet edge portion of the valve tip defines a undulating shape. [Item 53] The patch valve according to item 52, wherein an inner portion of the skirt has an undulating outlet edge stitched to the inlet edge portion of the valve tip. [Item 54] The patch valve according to any one of items 50 to 53, wherein an outer portion of the skirt is fixed to a row of struts defining an outlet end of the frame. [Item 55] The patch valve according to any one of items 50 to 54, wherein the outer portion of the skirt is stretched circumferentially when the frame is in the expanded configuration. [Item 56] The patch valve according to any one of items 50 to 55, wherein the skirt comprises a non-elastic fabric. [Item 57] The patch valve according to item 56, wherein the fabric comprises polyethylene terephthalate fibers. [Item 58] The polyethylene terephthalate fiber has a thickness of about 20 denier, the patch valve according to item 57. [Item 59] The polyethylene terephthalate fiber has a fiber spacing in the range from about 155 fibers per inch to about 180 fibers per inch, the patch valve according to item 57 or 58. [Item 60] The polyethylene terephthalate fiber has a fiber spacing of about 160 fibers per inch, the patch valve according to item 59. [Item 61] 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 the first direction nor the second direction is perpendicular to the fold, the patch valve according to any one of items 56 to 60. [Item 62] The first direction is generally perpendicular to the second direction that forms an angle of about 45 degrees with respect to the fold, the patch valve according to item 61. [Item 63] When the frame is in the expanded configuration, the first set of fibers extends generally parallel to a first set of struts of the frame, the second set of fibers extends generally parallel to a second set of struts of the frame, and the second set of struts overlaps the first set of struts to form a joint of the frame, the patch valve according to item 61 or 62. [Item 64] The tether extends at an oblique angle with respect to the fold, and the tether is configured to apply a tension to the skirt when the frame is in the expanded configuration, the patch valve according to any one of items 50 to 63. [Item 65] The oblique angle is about 45°, the patch valve according to item 64. [Item 66] The first end of the tether is positioned at the outflow edge portion of the outer portion of the skirt, and the second end of the tether is positioned adjacent to the fold, the patch valve according to any one of items 50 to 65. [Item 67] The patch valve according to any one of claims 50 to 66, wherein the tether comprises a stitching that is stitched to the outer portion of the skirt using a running stitch. [Claim 68] The patch valve according to any one of claims 50 to 67, wherein the tether comprises an elastic material. [Claim 69] An annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and An annular outer skirt that covers at least a portion of the outer surface of the frame comprising: A patch valve, wherein when the frame is in the radially compressed configuration, a portion of the outer skirt undulates to form a longitudinally extending folded flap. [Claim 70] The patch valve according to claim 69, wherein each flap is further folded circumferentially so as to maintain a small, contracted profile of the patch valve. [Claim 71] The patch valve according to claim 70, wherein each flap at least partially overlaps an adjacent flap in the circumferential direction. [Claim 72] The patch valve according to any one of claims 69 to 71, wherein the outer skirt is connected to a strut of the frame along a zigzag attachment line. [Claim 73] The patch valve according to claim 72, wherein the outer skirt is connected to the strut of the frame by stitching along the zigzag attachment line. [Claim 74] The patch valve according to claim 72 or 73, wherein the outer skirt is not connected to a strut of the frame or other components of the patch valve at locations not along the zigzag attachment line. [Claim 75] The patch valve according to claim 72 or 73, wherein the outer skirt is connected to the frame only along the zigzag attachment line. [Claim 76] The patch valve according to any one of claims 72 to 75, further comprising a plurality of valve tips, each valve tip having an inflow edge portion attached to the support column of the frame along the zigzag attachment line. [Claim 77] The patch valve according to any one of claims 69 to 76, wherein the flap is V-shaped. [Claim 78] The patch valve according to any one of claims 69 to 77, further comprising an annular inner skirt covering at least a portion of the inner surface of the frame, wherein the outer skirt is connected to the inner skirt via a fold extending around the inflow end of the frame. [Claim 79] The patch valve according to claim 78, wherein when the frame is in the radially expanded configuration, the outer skirt is configured to fit tightly against 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 in the radially compressed configuration, the inflow end of the frame is configured to extend axially to at least partially fill the axially extending gap. [Claim 80] The patch valve according to claim 78 or 79, wherein when the frame is in the radially expanded configuration, the axial length of the gap is in the range of about 4 mm to about 8 mm. [Claim 81] The patch valve according to claim 80, wherein the axial length of the gap is about 6 mm when the frame is in the radially expanded configuration. [Claim 82] The patch valve according to any one of claims 79 to 81, wherein when the frame is in the radially compressed configuration, the inflow end of the frame extends axially into the gap to completely fill the gap. [Claim 83] The patch valve according to any one of claims 78 to 82, wherein when the frame is in the radially compressed configuration, the inner skirt folds inwardly towards the inside of the frame. [Claim 84] A tether coupled to the outer skirt, the tether extending at an oblique angle to the fold so as to apply a pull to the outer skirt to prevent the fold from moving inwardly of the frame when the frame expands radially from the compressed configuration to the expanded configuration, the patch valve according to any one of paragraphs 78 to 83, further comprising a tether. [Paragraph 85] The patch valve according to paragraph 84, wherein the tether comprises a stitching stitched to the outer skirt using a running stitch. [Paragraph 86] The patch valve according to paragraph 84 or 85, wherein the tether comprises an elastic material. [Paragraph 87] A method of assembling a patch valve, Receiving an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration; Attaching the skirt to the frame such that the annular skirt has 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 being folded around the inlet end of the frame so as to define a fold between the inner portion and the outer portion; comprising The skirt is sized such 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 inlet 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 inlet end of the frame moves axially closer to the fold within the gap. [Paragraph 88] The method according to paragraph 87, wherein the step of attaching the annular skirt to the frame includes stitching an upper edge of the inner portion of the skirt to a selected row of strut sections of the frame from the inside of the frame. [Paragraph 89] The step of attaching the annular skirt to the frame includes the step of stitching the outer portion of the skirt to a row of struts that define the outflow end of the frame, the method according to claim 87 or 88. [Claim 90] The method according to any one of claims 87 to 89, further comprising the step of fixing a valve structure to the frame, the valve structure being configured to permit blood flow through the patch valve in one direction and to block blood flow in the opposite direction. [Claim 91] The valve structure includes a plurality of valve tips each having an inflow edge portion, the inflow edge portion of the valve tip defining a undulating shape, and the step of attaching the valve structure to the frame includes stitching the inflow edge portion of the valve tip to a row of interconnected strut sections of the frame along the circumferential direction, the method according to claim 90. [Claim 92] The method according to any one of claims 87 to 91, further comprising the step of coupling a tether to the skirt at an oblique angle to the fold so as to prevent the fold from moving inside the frame when the frame expands radially from the compressed configuration to the expanded configuration. [Claim 93] Receiving a patch valve comprising an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and an annular skirt that covers at least a portion of the outer surface of the frame; Compressing the frame to the radially compressed configuration such that a portion of the skirt undulates to form a longitudinally extending folded flap; Folding the flap circumferentially; and a method comprising. [Claim 94] The method according to claim 93, wherein the skirt is stitched to the struts of the frame along a zigzag attachment line. [Claim 95] The method according to claim 93 or 94, wherein the patch valve comprises a plurality of valve tips, and each valve tip has an inflow edge portion attached to the strut of the frame along the zigzag mounting line. [Claim 96] The method according to any one of claims 93 to 95, wherein the skirt covers at least a portion of the inner surface of the frame and forms a fold around the inflow end of the frame. [Claim 97] The method according to any one of claims 93 to 96, wherein the skirt is sized such that when the frame is in the expanded configuration, 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 within the gap. [Claim 98] The method according to claim 96 or 97, wherein the patch valve further comprises a tether coupled to the skirt at an angle oblique to the fold so as to prevent the fold from moving inside the frame when the frame is radially expanded from the compressed configuration to the expanded configuration. [Claim 99] The method according to any one of claims 93 to 98, further comprising loading the patch valve into a sheath of a delivery device, inserting the patch valve into a patient, advancing the patch valve through the patient's vasculature to an implantation site, and radially expanding the patch valve at the implantation site. [Claim 100] The method according to claim 99, wherein the step of radially expanding the patch valve comprises spreading the flap. [Claim 101] The method according to claim 100, wherein when the frame is in the radially expanded configuration, the skirt fits tightly against the outer surface of the frame.

Description of the Reference Numerals

[0172] 10 Patch valve 12 Stent, Frame 14 Inflow End 16 Outflow End 18 Valve Structure 20 Valve Tip 21 Inflow Edge Portion 22 Joint 24 Support 24a Outer Support 24b Inner Support 25 Support Section 26 Longitudinal Axis 28 Rivet, Pin, Hinge 28a, 28b Hinge 30 Annular Skirt 32 Inner Portion 34 Outer Portion 36 Fold 38 Upper Edge of Inner Portion 32 40 Upper Edge of Outer Portion 34 42 Gap 44 First Direction 46 Second Direction 48 Tether 48a First End 48b Second End 50 Actuator 52 Screw, Threaded Rod 54 First Mooring Portion, Cylinder, Sleeve 56 Second Mooring Portion, Threaded Nut 58 Mounting Member 60 Notch 62 Protrusion 64 Joint Mounting Member 110 Patch Valve 112 Frame 114 Inflow End 116 Outflow End 118 Valve Structure 120 Valve Tip 121 Wavy Line, Mounting Line, Suture Line 122 Suture 124 Support Section 126 Longitudinal Axis 130 Outer Skirt, Skirt 136 Lower Edge 140 Upper Edge 150 Flap 210 Patch valve 212 Frame 216 Outlet end 221 Wavy line, stitching line, mounting line 222 Stitching 230 Outer skirt, skirt 250 Flap Columns of strut sections I, II, III, IV, V F Force L Length of gap 42 α Angle with respect to fold 36

Claims

1. A prosthetic valve comprising: an annular frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration; a valve structure positioned within the frame and configured to permit blood flow through the prosthetic valve in one direction and prevent blood flow in an opposite direction; 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, the skirt folded around the inflow end of the frame to define a fold between the inner portion and the outer portion; Equipped with the skirt is sized such that when the frame is in the expanded configuration, the outer portion of the skirt conforms to the outer surface of the frame, 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 within the gap closer to the fold.

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

3. A prosthetic valve as described in claim 1 or 2, wherein the outer portion of the skirt is stretched circumferentially when the frame is in the expanded configuration.

4. A prosthetic valve as described in any one of claims 1 to 3, wherein the skirt comprises a non-elastic fabric.

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

6. A prosthetic valve as described in any one of claims 1 to 5, 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 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, which forms an angle of approximately 45 degrees with respect to the fold.

8. A prosthetic valve as described in any one of claims 1 to 7, wherein the valve structure comprises a plurality of leaflets, each leaflet having an inflow edge portion, and the inflow edge portions of the leaflets define an undulating shape.

9. The prosthetic valve of claim 8, wherein the inner portion of the skirt has a contoured outflow edge that is sutured to the inflow edge portions of the valve leaflets.

10. A prosthetic valve as described in any one of claims 1 to 9, further comprising a tether coupled to the skirt, the tether configured to prevent the fold from moving inwardly of the frame when the frame is radially expanded from the compressed configuration to the expanded configuration.

Images