Valve prosthesis with gradual release to improve positioning

Abstract

A valve prosthesis includes a self-expanding frame and a prosthetic valve coupled to an interior of the frame. The frame includes a plurality of end crowns at a first end thereof, and a first blade connected to the first end crown by a first rod. The first end of the frame is collapsible to a collapsed configuration when a constraining force is applied to the first blade and the end crown, is configured to expand from the collapsed configuration to a partially deployed configuration when the constraining force is removed from the end crown but still applied to the first blade, and is configured to expand to a fully deployed configuration when the constraining force is removed from the end crown and the first blade. A first value of a lateral dimension of the first end in the partially deployed configuration is at least 70% of a second value of a lateral dimension of the first end in the fully deployed configuration.

Description

Technical Field

[0001] The present invention relates to a valvular prosthesis having a gradual release to improve positioning and in particular having a paddle having an elongated stem to gradually release the valvular prosthesis from a delivery device. Background Art

[0002] Transcatheter heart valve prostheses have been developed to replace the function of defective native heart valves. Transcatheter heart valve prostheses generally include a stent or a frame, wherein a prosthetic valve is connected to the frame. The transcatheter heart valve prosthesis is delivered to the native heart valve in a radially compressed configuration, such as by a catheter, and then radially expanded or deployed at the native heart valve. Accurate positioning of the heart valve prosthesis is important because inaccurate positioning may lead to conduction disorders, coronary artery obstruction, and / or undesirable paravalvular leakage and / or regurgitation at the implantation site. For example, in a self-expanding heart valve prosthesis, the final release of the heart valve prosthesis from the catheter may cause jumping and / or oscillation, which may cause the heart valve prosthesis to move from the desired position.

[0003] Therefore, it is desirable to minimize jumps and / or oscillations of a heart valve prosthesis when deployed at the native heart valve to facilitate accurate positioning of the heart valve prosthesis. Summary of the invention

[0004] Embodiments of the present invention are directed to a valve prosthesis that facilitates its delivery with improved positioning accuracy.

[0005] In a first example, a valve prosthesis includes a self-expanding frame, the self-expanding frame including: a plurality of struts, the plurality of struts forming a plurality of end crowns at a first end of the self-expanding frame; and a first paddle, the first paddle connected to a first end crown of the plurality of end crowns by a first rod. When a restraining force is applied to the first paddle and the plurality of end crowns, the self-expanding frame can be collapsed to a collapsed configuration at the first end of the self-expanding frame. The self-expanding frame is configured to expand from a collapsed configuration to a partially expanded configuration when the restraining force is removed from the plurality of end crowns but still applied to the first paddle. In the partially expanded configuration, the self-expanding frame has a first value of a lateral dimension at the first end. The self-expanding frame is further configured to expand from a partially expanded configuration to a fully expanded configuration when the restraining force is removed from the plurality of end crowns and from the first paddle. In the fully expanded configuration, the self-expanding frame has a second value of a lateral dimension at the first end, wherein the first value is at least 70 percent of the second value. The valve prosthesis further includes a prosthetic valve component coupled to the interior of the self-expanding frame.

[0006] In a second example, in the valve prosthesis of the first example, the first value of the lateral dimension is within a range of 80 percent to 90 percent of the second value of the lateral dimension.

[0007] In a third example, in the valve prosthesis of the first or second example, in the collapsed configuration, the plurality of end crowns store potential energy, and when the self-expanding frame expands from the collapsed configuration to the partially expanded configuration, the stored potential energy decreases by at least 40 percent.

[0008] In a fourth example, in the valve prosthesis of the third example, the stored potential energy decreases by at least 50 percent when the self-expanding frame expands from the collapsed configuration to the partially-expanded configuration.

[0009] In a fifth example, in the valve prosthesis described in any one of the first to fourth examples, the self-expanding frame disperses a first level of peak kinetic energy when expanding from a collapsed configuration to a partially expanded configuration, and the self-expanding frame disperses a second level of peak kinetic energy when expanding from a partially expanded configuration to a fully expanded configuration, and wherein the second level of peak kinetic energy is less than 70 percent of the first level of peak kinetic energy.

[0010] In a sixth example, in the valve prosthesis of the fifth example, the second level of peak kinetic energy is in a range of 5 millijoules (mJ) to 20 mJ.

[0011] In a seventh example, in the valve prosthesis of the sixth example, the second level of peak kinetic energy is in a range of 10 mJ to 15 mJ.

[0012] In an eighth example, in the valve prosthesis described in any one of the first to seventh examples, the first rod has a length of at least 4 mm.

[0013] In a ninth example, in the valve prosthesis described in any one of the first to eighth examples, the first rod is formed as a spring having a plurality of bends, and the spring is stretched when the self-expanding frame expands from the collapsed configuration to the partially expanded configuration.

[0014] In a tenth example, in the valve prosthesis of the ninth example, the spring has a spring constant within a range of 0.2 N / mm to 5 N / mm.

[0015] In an eleventh example, in the valve prosthesis described in any one of the first to tenth examples, when the first end is in a radially collapsed configuration, the first rod has at least one bend connecting a first segment of the first rod and a second segment of the first rod, the first segment extends from the first end crown, and the second segment extends to the first blade, wherein a gap between the first segment and the second segment is less than 1 mm.

[0016] In a twelfth example, the valve prosthesis described in any one of the first to eleventh examples further includes a second paddle connected to a second end crown of the plurality of end crowns via a second rod, the first paddle and the second paddle being located on opposite sides of the first end of the self-expanding frame.

[0017] In a thirteenth example, in the valve prosthesis described in the twelfth example, the first rod and the second rod have different lengths.

[0018] In a fourteenth example, in the valve prosthesis described in the twelfth example, the first rod and the second rod have substantially the same length.

[0019] In a fifteenth example, a delivery system includes a valve prosthesis and a delivery device for percutaneously delivering the valve prosthesis. The valve prosthesis includes a self-expanding frame and a prosthetic valve disposed within the self-expanding frame, the self-expanding frame including a body, a plurality of end crowns disposed at a first end of the self-expanding frame, a first paddle, and a first rod connecting the first paddle to a first end crown among the plurality of end crowns. The delivery device includes: a sheath configured to constrain the valve prosthesis in a radially collapsed configuration, the sheath being retractable in a proximal direction; and a first shaft for receiving the valve prosthesis thereon. In the delivery configuration of the delivery system, the sheath covers the valve prosthesis so that the valve prosthesis is in a radially collapsed configuration and surrounds the first shaft. When the distal end of the sheath is retracted to a first position (in the first position, the sheath releases the plurality of end crowns while still constraining the first paddle), the first end of the self-expanding frame of the valve prosthesis is configured to expand from a radially collapsed configuration to a partially expanded configuration, so that the first end of the self-expanding frame radially expands to a first value of a lateral dimension. With the distal end of the sheath retracted to a second position (in the second position, the sheath releases the plurality of end crowns and releases the first paddle), the first end of the self-expanding frame of the valve prosthesis is configured to expand from a partially deployed configuration to a fully deployed configuration such that the first end of the self-expanding frame radially expands to a second value of the lateral dimension, and wherein the first value is at least 70 percent of the second value.

[0020] In a sixteenth example, in the delivery system of the fifteenth example, in the radially compressed configuration, the first rod has at least one bend connecting a first segment and a second segment of the first rod, the first segment extending from the first end crown, and the second segment extending to the first paddle.

[0021] In a seventeenth example, in the delivery system of the sixteenth example, the first shaft is configured to push the first section against the second section in a proximal direction during retraction of the sheath.

[0022] In an eighteenth example, in the delivery system described in the sixteenth example, the delivery device includes a second shaft that surrounds the first shaft and forms or is connected to a prosthetic retaining member at a distal end of the second shaft, wherein the prosthetic retaining member includes a first recessed portion for receiving a first paddle when the self-expanding frame is in a delivery configuration or in a partially deployed configuration.

[0023] In a nineteenth example, in the delivery system of the eighteenth example, the prosthetic retention member includes a second concave portion adjacent to the first concave portion for receiving at least one bend of the first rod when the self-expanding frame is in the delivery configuration.

[0024] In a twentieth example, in the delivery system described in the eighteenth example, the distal end of the prosthesis retention member includes a protrusion configured to push against the first section of the first rod in a proximal direction. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings incorporated herein constitute a part of this specification and illustrate embodiments of the delivery system. In conjunction with the specification, these drawings further explain the original implantation of the prosthesis described herein and enable those skilled in the relevant art to manufacture, use and implant the prosthesis described herein. In the accompanying drawings, the same reference numerals indicate the same or functionally similar elements.

[0026] Figure 1A A top or outflow end view of a valve prosthesis according to an embodiment of the present invention is shown.

[0027] Figure 1B Shown Figure 1A Side view of the valve prosthesis.

[0028] Figure 1C and Figure 1D An enlarged view of a connector of the valve prosthesis of FIG. 1 is shown in accordance with an embodiment of the present invention.

[0029] Figure 2A A side view of a valve prosthesis according to another embodiment of the present invention is shown.

[0030] Figure 2B The present invention shows an embodiment of the Figure 2A Magnified view of the connector of a valve prosthesis.

[0031] Figure 3A A side view of a delivery system for delivering a valve prosthesis according to an embodiment of the present invention is schematically illustrated.

[0032] Figure 3B Schematically illustrates an embodiment of the present invention Figure 3A Side view of a delivery system with the balloon of the delivery system retracted to expose a valve prosthesis.

[0033] Figure 3C A perspective view of a distal portion of a delivery system is schematically shown, wherein for illustration purposes only, the valve prosthesis is in a delivery configuration and the exterior is not shown.

[0034] Figure 4A prosthesis retention member of a delivery system according to an embodiment of the present invention is schematically illustrated, wherein paddles of a connector of a heart valve prosthesis are arranged in the prosthesis retention member.

[0035] Figure 5 A prosthesis retention member of a delivery system according to an embodiment of the present invention is schematically illustrated, wherein paddles of a connector of a heart valve prosthesis are arranged in the prosthesis retention member.

[0036] Fig. 6A and Figure 6B The delivery of a valve prosthesis according to an embodiment of the present invention to the native annulus of an aortic heart valve is schematically illustrated.

[0037] Fig. 7A and Figure 7B A valve prosthesis according to an embodiment of the present invention is schematically illustrated, which is partially deployed at a native aortic valve, wherein a constraining force is applied to the end crowns of the valve prosthesis.

[0038] Figure 8 A valve prosthesis according to an embodiment of the invention is schematically illustrated in a partially deployed configuration at a native aortic valve, with the end crowns released from a balloon at the distal end of an outer sheath.

[0039] Fig. 9 A valve prosthesis is schematically illustrated in a fully deployed configuration with the end crowns and paddles released from a balloon at the distal end of an outer sheath in accordance with an embodiment of the present invention.

[0040] Fig.10 is a graph illustrating the reduction in strain potential energy as the end crown moves to a partially deployed configuration in accordance with an embodiment of the present invention.

[0041] Fig.11 A graph illustrating the kinetic energy of an end crown as it moves to a partially deployed configuration and then to a fully deployed configuration is provided in accordance with an embodiment of the present invention. DETAILED DESCRIPTION

[0042] Specific embodiments of the present invention are now described with reference to the figures, wherein the same reference numerals indicate the same or functionally similar elements. Unless otherwise specified, the terms "distal" and "proximal" refer to the position or direction relative to the treating clinician when used in the description of the delivery device below. "Distal" and "distalward" are positions away from the clinician or in the direction away from the clinician, and "proximal" and "proximal" are positions close to the clinician or in the direction toward the clinician. The terms "distal" and "proximal" refer to the direction of blood flow when used with respect to the device to be implanted in the blood vessel. Therefore, "distal" and "distalward" refer to downstream positions or downstream directions, and "proximal" and "proximal" refer to upstream positions or upstream directions. In addition, the term "self-expanding" is used in the following description of one or more stent structures of the prosthesis of this article, and is intended to convey that these structures are formed or formed by materials that can be provided with mechanical memory so that the structure returns to the radially expanded deployment configuration from a radially compressed or contracted delivery configuration.

[0043] The following detailed description is merely illustrative in nature and is not intended to limit the invention, or to limit the application and use of the invention. Various embodiments of the present disclosure may be used, for example, to deliver a heart valve prosthesis within a native aortic valve, to deliver a heart valve prosthesis within a native mitral valve, to deliver a heart valve prosthesis within a native pulmonary valve, to deliver a heart valve prosthesis within a native tricuspid valve, to deliver a venous valve, or to deliver a heart valve prosthesis within a failed previously implanted prosthesis. Furthermore, no one wishes to be bound by any expressed or implied theory presented in the preceding technical field, background, summary, or the following detailed description.

[0044] Embodiments of the present invention relate to a valve prosthesis that facilitates its delivery with improved positioning accuracy. The valve prosthesis has a first end and a second end, the first end being the inflow end or proximal to the second end when the valve prosthesis is loaded onto a delivery device. In some cases, positioning accuracy may be affected by the possibility that after a clinician has placed the valve prosthesis at a target location using a delivery device, the valve prosthesis may move away from the target location in situ when the first end of the valve prosthesis is released from the delivery device. More specifically, if a high level of potential energy is stored within the first end of the valve prosthesis when the first end is about to be fully released from the delivery device, this high level of potential energy may be converted into a high level of kinetic energy of the first end of the valve prosthesis. The high level of kinetic energy may cause the valve prosthesis to move or tilt when fully deployed or released from the delivery device, which is undesirable. Embodiments of the present invention relate to a valve prosthesis that includes a connector having a paddle and a rod, wherein the rod allows a first end of the valve prosthesis, or more specifically an end crown at the first end, to move outward to a partially deployed configuration and expand the size of the valve prosthesis when the paddle has not yet been released from a delivery device. More specifically, the partially deployed configuration may involve the end crown moving at least 70 percent of the distance required to reach the fully deployed configuration. Such movement may reduce the residual potential energy stored by the end crown at the first end of the valve prosthesis when the paddle is about to be released from the delivery device, which will allow the end crown to expand the frame from the partially deployed configuration to the fully deployed configuration. The reduced stored potential energy may reduce the kinetic energy of the end crown when the end crown expands the frame from the partially deployed configuration to the fully deployed configuration. The reduced kinetic energy may reduce the likelihood of the valve prosthesis tilting or otherwise shifting after the valve prosthesis is fully deployed, and may therefore facilitate accurate placement of the valve prosthesis. Embodiments of the present invention are further directed to a delivery device having a prosthesis retention member including a recessed portion and / or a protruding portion for supporting a rod of a connector.

[0045] Figures 1A to 1D An embodiment of a valve prosthesis 101 is shown. Figures 1A to 1D In the embodiment of the present invention, the valve prosthesis is a transcatheter heart valve prosthesis. The valve prosthesis 101 generally includes a self-expanding stent or frame 106 and a prosthetic valve 113 coupled to the interior of the self-expanding frame 106. Those skilled in the art will appreciate that Figures 1A to 1D An example of a valve prosthesis is shown, and Figures 1A to 1D Existing components shown may be removed, and / or additional components may be added.For example, valve prosthesis 101 may include features described in US Pat. No. 7,914,569 to Nguyen et al., which is incorporated herein by reference in its entirety.

[0046] like Figure 1BAs depicted, self-expanding frame 106 can include a plurality of struts 105 and a plurality of crowns 103 that form a structure having an interior space for prosthetic valve 113. Multiple struts 105 can collectively surround the interior of self-expanding frame 106 and can provide strength or structural support to frame 106 after valve prosthesis 101 has been deployed at a treatment site. Each crown 103 can be a curved segment extending between a pair of opposing struts 105. More particularly, crowns 103 and struts 105 can form a lattice frame having side openings that are diamond-shaped or form some other shape.

[0047] In an embodiment, the self-expanding frame 106 of the valve prosthesis 101 can have a structure formed or formed from a material that can be provided with mechanical memory to return the structure from a radially collapsed or contracted delivery configuration to a radially expanded deployed configuration. As used herein, "self-expanding" means that the frame 106 has a mechanical memory to return to a radially expanded deployed configuration. Mechanical memory can be imparted to the wire or tubular structure forming the frame 106 by heat treatment to achieve spring tempering in, for example, stainless steel or to provide shape memory in a susceptible metal alloy (such as nitinol) or a polymer (such as any of the polymers disclosed in U.S. Patent Application Publication No. 2004 / 0111111 to Lin, the entire contents of which are incorporated herein by reference).

[0048] Figure 1A and Figure 1B The valve prosthesis 101 is depicted in a radially expanded deployed configuration, or more specifically a fully deployed configuration. The valve prosthesis 101, or more specifically the self-expanding frame 106, can also collapse from the deployed configuration back to a radially collapsed configuration. That is, if a restraining force is applied to the self-expanding frame 106 along the radial axis R of the frame 106 / valve prosthesis 101, the restraining force can cause the frame 106 of the valve prosthesis 101 to radially collapse to the radially collapsed configuration. Figure 1A and Figure 1B As shown, the radial axis R can be an axis orthogonal to the longitudinal axis L of the valve prosthesis 101 / frame 106. The restraining force can be applied to the frame 106 before and / or during delivery of the valve prosthesis 101 to constrain the frame 106 of the valve prosthesis 101 or otherwise collapse the frame of the valve prosthesis and reduce its cross-section for easier movement within the patient's body. Therefore, the radially collapsed configuration can also be referred to as a delivery configuration. When the valve prosthesis 101 has been delivered to the treatment site, the restraining force can be removed, and the mechanical memory of the self-expanding frame 106 can cause the frame 106 to expand along the radial axis R to return to the radially expanded deployed configuration.

[0049] In an embodiment, when the self-expanding frame 106 of the valve prosthesis 101 is in the expanded configuration, or more specifically the fully expanded configuration, the self-expanding frame 106 can have a generally tubular configuration or other support configuration for valve replacement. In the tubular configuration, the self-expanding frame 106 can have a circular cross-section at the first end or outflow end 102 and / or the second end or upstream end 104 of the frame 106. In another example, the self-expanding frame 106 can have a cross-section of some other shape, such as an elliptical, rectangular, hexagonal, rectangular, square, or other polygonal shape. Figure 1A and Figure 1B In an example of a self-expanding frame 106, the self-expanding frame 106 can have a cross-section that varies in size along the longitudinal axis L of the frame 106 / prosthesis 101. In such an example, the self-expanding frame 106 can have a longitudinally asymmetric hourglass configuration, wherein the first end 102 has an enlarged cross-section relative to the second end 104. Figure 1A The valve prosthesis 101 in can be used, for example, as an aortic valve replacement, a mitral valve replacement, or for some other purpose. In another example, the valve prosthesis of the embodiments herein can include a self-expanding frame having a cross-section along the longitudinal axis L that is uniform in size.

[0050] Figure 1A A valvular prosthesis 101, or more specifically a self-expanding frame 106, is shown having a value r for a lateral dimension of the frame 106 at a first end 102 of the frame 106. fd . The lateral dimension can be a dimension that measures the size of the self-expanding frame 106 along the radial axis R, or more specifically measures the size of a specific cross-section of the self-expanding frame 106, such as the cross-section at the first end 102 of the frame 106. As an example, the lateral dimension can be the width of the self-expanding frame 106. If the self-expanding frame has a circular cross-section, the lateral dimension can be the radius or diameter of the cross-section. In another example, if the cross-section is elliptical, the lateral dimension can be the size of the major axis or minor axis of the elliptical cross-section.

[0051] The prosthetic valve 113 may include valve leaflets that form, for example, a bicuspid or tricuspid replacement valve that allows blood to flow in only one direction. For example, when the valve prosthesis 101 is deployed at the treatment site, the first end 102 of the valve prosthesis 101 may be the outflow end, and the second end 104 may be the inflow end. After the valve prosthesis 101 is deployed, the prosthetic valve 113 may only allow blood to flow in the direction from the inflow end to the outflow end. The valve leaflets of the prosthetic valve 113 may be sutured or otherwise securely and sealingly attached to the inner surface of the frame 106 and / or the graft material 111 surrounding or lining the frame 106. The leaflets are attached to the graft material 111 along their bases, for example, using sutures or suitable biocompatible adhesives. Adjacent leaflet pairs are attached to each other at their lateral ends to form commissures. The orientation of the leaflets within the frame 106 changes depending on which end of the valve prosthesis 101 is the inflow end and which end of the valve prosthesis 101 is the outflow end, thereby ensuring unidirectional blood flow through the heart valve prosthesis 101 .

[0052] In an embodiment, the leaflets of the prosthetic valve 113 can be made of pericardial material; however, the leaflets can be made of another material instead. Natural tissue for replacing the valve leaflets can be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue (e.g., pericardial patches), bypass grafts, blood vessels, intestinal submucosal tissue, umbilical cord tissue, etc. from humans or animals. Synthetic materials suitable for use as leaflets include those commercially available from Invista North America SARL of Wilmington, Delaware. Polyester, other cloth materials, nylon blends, polymeric materials, and vacuum deposited nitinol manufacturing materials. One polymer material that can be made into the leaflet is an ultra high molecular weight polyethylene material, which is commercially available from Royal DSM of the Netherlands under the trade name DYNEEMA. For certain leaflet materials, it may be desirable to cover one or both sides of the leaflet with a material that prevents or minimizes overgrowth. It is further desirable that the leaflet material is durable and does not stretch, deform, or fail.

[0053] In an embodiment, the graft material 111 can also be a natural or biological material, such as pericardium or another membrane tissue, such as intestinal submucosa. Alternatively, the graft material 111 can be a low-porosity woven fabric, such as polyester, polyester fabric or PTFE, which produces a one-way fluid path when attached to the support. In one embodiment, the graft material 111 can be a knitted or woven polyester, such as polyester or PTFE knitted fabric, which can be utilized when it is desired to provide a medium for tissue ingrowth and to stretch the fabric to meet the ability of a curved surface. For example, when it is desired to provide a medium for tissue ingrowth on one side and provide a smooth surface on the other side, polyester velvet fabric can be used alternatively. For example, these and other suitable cardiovascular fabrics can be purchased from Bard Peripheral Vascular, Inc. in Tempe, Arizona.

[0054] like Figure 1B As shown, the plurality of crowns 103 and struts 105 of the frame 106 can form a series of end crowns, also referred to as end crowns, at the first end 102 and the second end 104 of the self-expanding frame 106. More specifically, a plurality of end crowns 103A can be formed at the first end 102 of the frame 106. 1 -103A n , and a plurality of end crowns 103B may be formed at the second end 104 of the frame 106 1 -103B n The end crown 103A at the first end 102 1 -103A n and the end crown 103B at the second end 104 1 -103B n The number of end crowns 103A may depend on the size of the valve prosthesis 101 and its application. 1 -103A n and multiple end crowns 103B 1 -103B n Each may have 5-20 end crowns. When the self-expanding frame 106 is in the radially collapsed configuration, a constraining force may be applied to the frame 106 and, therefore, to the end crowns 103A. 1 -103A n and end crown 103B 1 -103B n Apply restraint. When the end crown (e.g., 103A k )When the restraining force is removed, the mechanical memory of the frame 106 can cause the end crown to move in a radially outward direction away from the center of the self-expanding frame 106 so as to expand the frame 106 along the radial axis R.

[0055] exist Figures 1A to 1D In the embodiment of the present invention, the valve prosthesis 101 includes a plurality of end crowns 103A at the first end 102 of the frame 106. 1 -103A n A first connector 107A extending from one of the first and second ends 102 of the frame 106, and a plurality of end crowns 103A extending from the first end 102 of the frame 106 1 -103A n As described above, in the illustrated embodiment, the first end 102 of the frame 106 is the outflow end. However, in other embodiments, depending on the replacement of the native heart valve with the valve prosthesis 101 and / or the delivery path of the delivery device in which the valve prosthesis 101 is disposed, the first connector 107A and the second connector 107B may extend from the corresponding end crowns of the plurality of end crowns at the second end 104 of the frame 106.

[0056] Figure 1C An enlarged view of the first connector 107A is shown. As shown, the first connector 107A is connected to the plurality of end crowns 103A. 1 -103A n The first end crown 103A k The first connector 107A may be located at least on the first end crown 103A. k For example, when the valve prosthesis 101 is in the radially collapsed / delivery configuration or in the partially expanded configuration, the first connector 107A can connect at least the first end crown 103A to the valve prosthesis 101. k The prosthetic retention member connected to the delivery device, as described in more detail below. In the radially collapsed configuration and the partially expanded configuration, a restraining force can be applied to the first connector 107A, and the restraining force can keep the first connector 107A substantially stationary relative to the prosthetic retention member or the capsule / outer sheath of the delivery device. Because the first connector 107A is substantially stationary in this situation, it can restrict the first end crown 103A directly connected to the first connector 107A from being moved. k outward movement and can limit the direct or indirect connection to the first end crown 103A k Outward movement of the adjacent end crowns.

[0057] exist Figures 1A to 1D In the embodiment of the present invention, the first connector 107A includes a first blade 117A and a first rod 115A. Figure 1C In some cases, the first blade 117A and / or the first rod 115A can be a flat member. The first rod 115A can be located between the first blade 117A and the first end crown 103A. k and can connect the first blade 117A to the first end crown 103A kThe blade 117A may be relatively wider than the first rod 115A, or may have a greater width overall. The first blade 117A may have a semicircular shape (eg, Figure 1C ) or any other shape (such as circular, rectangular, triangular shape). The first paddle 117A may have a radiopaque marker 119A, such as Figure 1C As shown. In some embodiments, first paddle 117A can have a shape that can cooperate with a recess or other portion of a prosthetic retaining member. When valve prosthesis 101 is in a collapsed / delivery configuration, first paddle 117A can cooperate with the recess of the prosthetic retaining member to assist in constraining the self-expanding frame 106 of valve prosthesis 101 to the collapsed / delivery configuration and prevent the valve prosthesis from moving longitudinally within the capsule / outer sheath of the delivery system. When valve prosthesis 101, or more specifically self-expanding frame 106, is in a fully expanded configuration, first paddle 117A can be released from the recess of the prosthetic retaining member.

[0058] In an embodiment, the mechanical memory of the self-expanding frame 106 can cause the self-expanding frame 106 to store potential energy when the restraining force restrains the frame 106 to the collapsed configuration. The potential energy can be stored at least partially in the end crowns, including the end crown 103A at the first end 102 of the frame 106. 1 -103A n When the restraining force is removed, the potential energy can be converted into kinetic energy that causes the self-expanding frame 106 to expand along the radial axis R, which returns the frame 106 to an expanded configuration, such as a fully expanded configuration, in which the lateral dimension at the first end 102 of the frame 106 / prosthesis 101 has a value r fd The expansion of the self-expanding frame 106 can be achieved by the end crown 103A 1 -103A n The lateral dimension at the first end 102 of the frame 106 in an outward direction away from the central longitudinal axis of the frame 106 has a value r fd As described above, if the end crown 103A 1 -103A n When they reach these respective positions associated with the fully deployed configuration, they have too much kinetic energy, and the end crown 103A 1 -103A n may tend to oscillate about these positions before the kinetic energy is dissipated. Oscillation increases the likelihood that valve prosthesis 101 may be displaced from the desired implantation site or desired implantation depth. Similarly, if end crown 103A 1 -103A nWith too much potential energy, the valve prosthesis 101 may "jump" when released, which may also shift the position of the prosthesis from the desired implant site or desired implant depth. Such shifting may increase the likelihood of valve leakage, pacing problems, and / or valve pop-out.

[0059] In an embodiment, the first rod 115A can be configured to be disposed at the end crown 103A. 1 -103A n 106. The first paddle 117A may be configured to extend from the first end 102 of the valve prosthesis 101 to the partially expanded configuration, and the ... 1 -103A n The first rod 115A may have sufficient slack and / or deformability (as discussed below) to allow the end crown 103A at the first end 102 of the self-expanding framework 106 to be released from the balloon / outer sheath. 1 -103A n More specifically, the first rod 115A can allow the end crown 103A to be in a partially expanded configuration. 1 -103A n The self-expanding frame expands the lateral dimension at the first end 102 thereof to at least 70% of the value of the lateral dimension at the first end 102 thereof in the fully expanded configuration. In other words, when the first paddle 117A has not yet been released from the prosthetic retaining member, the first rod 115A may still allow one or more end crowns (e.g., 103A) to be opened. k ) moves outwardly away from a baseline position associated with the collapsed configuration by a distance that is at least 70% of the total distance separating the baseline position from a final position associated with the fully expanded configuration.

[0060] This expansion from the collapsed configuration to the partially expanded configuration may provide an initial release of some of the potential energy stored in self-expanding frame 106 of valve prosthesis 101. This initial release of potential energy may reduce the total amount of potential energy still stored by or otherwise retained in self-expanding frame 106 in the partially expanded configuration. The reduced amount of potential energy stored in the partially expanded configuration may cause frame 106 to expand at end crown 103A. 1 -103A n (including the first end crown 103A k) is at end crown 103A 1 -103A n The frame 106 has relatively little kinetic energy when moving toward the corresponding final position associated with the fully deployed configuration. 1 -103A n The reduced level of kinetic energy at the end crown 103A can be reduced or eliminated 1 -103A n Oscillation after they reach the final position associated with the fully deployed configuration, which may aid in accurate placement of valve prosthesis 101 and reduce positional errors.

[0061] In an embodiment, the first rod 115A may have a length large enough to allow at least the first end crown 103A to k The first paddle 117A moves a considerable amount, even when the first paddle 117A is not released from the prosthetic retaining member. For example, but not limited to, the first rod 115A can have a length of at least 4 mm. In this embodiment, the length of the first rod 115A or any other rod can refer to the length of the rod when it is straightened or the arc length measured along the path or curve formed by the rod. As described above, by allowing the end crown 103A 1 -103A n By further expanding radially outward before the paddles 117A are released, the first rod 115A can allow the self-expanding frame 106 to reach a partially deployed configuration that is closer to a fully deployed configuration than other rod designs. For example, if the restraining force is still applied to the paddles 117A, but the plurality of end crowns 103A are no longer 1 -103A n Applying a restraining force, the first rod 115A can allow at least the first end crown 103A to move away from the paddle 117A. k Moving outward along the radial axis R, as described in more detail below Figure 8 shown.

[0062] As further described above, the first rod 115A can be sufficiently long and / or sufficiently deformable to allow the self-expanding frame 106 to be deformed at its first end 102 (the plurality of end crowns 103A). 1 -103A n The self-expanding frame 106 is configured to expand the lateral dimension of the frame 106 at the position where the frame 106 is located so as to have a value of at least 70 percent of the value of the lateral dimension in the fully expanded configuration in the partially expanded configuration. More specifically, the self-expanding frame 106 is configured to expand the lateral dimension of the frame 106 at the first end 102 (the plurality of end crowns 103A). 1 -103A nThe lateral dimension at the first end 102 of the self-expanding frame 106 can have a first value in the partially deployed configuration and can have a second value in the fully deployed configuration. In this example, the first rod 115A can be long enough and / or have sufficient deformability to allow the first value associated with the partially deployed configuration to be at least 70 percent of the second value associated with the fully deployed configuration. The lateral dimension at the first end 102 of the self-expanding frame 106 can measure the first end crown 103A k How much the cross-section of the self-expanding frame 106 at its first end 102 has expanded. In an embodiment, the lateral dimension at the first end 102 of the frame 106 can be determined by the first end crown 103A. k The distance between the first rod 115A and the central longitudinal axis of the frame 106 at the first end 102 is defined. In such an embodiment, the first rod 115A can have sufficient length and / or deformability to allow the first end crown 103A to k At least 70 percent of the total distance required to move along the radial axis R to reach the fully deployed configuration. More specifically, if in the fully deployed configuration, the first end crown 103A k Separated from the central longitudinal axis at the first end 102 by a distance R fd The first rod 115A may have a length and / or deformability that is large enough to allow the first end crown 103A to be in a partially expanded configuration. k Move to a distance R from the central longitudinal axis pd , where R pd YesR fd At least 70 percent.

[0063] In an embodiment, when the first end 102 of the frame 106 is in the radially compressed configuration, Figure 1C The first rod 115A depicted in FIG. 1 may have a first section 115A connecting the first rod 115A. 1 and the second section 115A 2 At least one curved portion 114A 1 (also referred to as a curved portion). In a more specific embodiment, the first rod 115A may include a plurality of curved portions 114A. 1 -114A 3 . Bend 114A 1 -114A 3 Allows for relatively long stems to fit into the end crown 103A 1 -103A n As described above, when the frame 106 is in the partially deployed configuration in which the first paddle 117A is still constrained, the longer rod can be the end crown (e.g., 103A). k) provides more slack for outward movement, wherein such movement can release some of the potential energy stored at the end crown, which in turn reduces the amount of kinetic energy at the end crown after releasing the first paddle 117A.

[0064] In some cases, at least one bend 114A 1 , or more specifically, a plurality of curved portions 114A 1 -114A 3 The first rod 115A can be formed as a spring that is stretchable when the self-expanding frame 106 expands from the collapsed configuration to the partially expanded configuration. 1 -114A 3 The first rod 115A may be provided with stretchability or more generally deformability. Deformability may refer to the ability of a spring to undergo elastic deformation, while stretchability may refer to the ability of a spring to be stretched. Stretching of the spring refers to causing the curved portion 114A to 1 -114A 3 More specifically, the curved portion, such as 104A 1 The curved portion may be a curved portion that provides a connection between adjacent segments (such as 115A) of the first rod 115A. 1 and 115A 2 ) is the pivot point. When the spring is stretched, the adjacent segment 115A 1 and 115A 2 can be pulled further apart from each other, but the two segments 115A 1 and 115A 2 The connection can still be maintained at the pivot point. Further, the extension of the spring can reduce the degree of curvature of this curved portion. Therefore, the curved portion 114A 1 -114A 3 The first rod 115A may be configured as a stretchable spring. In this case, the first paddle 117A connected to the first rod 115A may be referred to as a spring paddle. The spring formed by the first rod 115A may have a spring constant in the range of 0.2 to 5 N / mm (e.g., a spring constant of 1 N / mm). However, this is not meant to be limiting, and other values ​​may be used.

[0065] In some cases, at least one bend 114A 1 In the first section 115A 1 With the second section 115A 2 There is only a small gap between them, such as Figure 1C As shown. The small gap may be, for example, equal to or less than 0.1 mm. This limited gap may aid in the deployment of valve prosthesis 101 by preventing too much movement of stem 115A when the sheath is retracted past stem 115A, as discussed in more detail below.

[0066] The valve prosthesis of the embodiments herein may include only a single connector, exactly two connectors, or some other number of connectors (e.g., exactly three connectors, or at least four connectors). The prosthetic retention member may have the same number of recesses as the number of connectors, wherein each of the recesses corresponds to one of the connectors. In some cases, the connectors may be equally spaced circumferentially around first end 102 of self-expanding frame 106 of valve prosthesis 101. Figures 1A to 1D In the embodiment of the present invention, valve prosthesis 101 includes a first connector 107A, and further includes a second connector 107B. Figure 1D A magnified view of the second connector 107B is provided in FIG. The first connector 107A can be connected to the first end crown 103A. k The second connector 107B may extend from the second end crown 103A. m The second connector 107B may include a second paddle 117B and a second connector 107B connected to the second end crown 103A. m In this embodiment, the first connector 107A and the second connector 107B can be arranged on the plurality of end crowns 103A. 1 -103A m The first connector 107A and the second connector 107B are located on opposite sides of the cross-section at the first end 102 of the self-expanding frame 106, i.e., 180 degrees apart around the circumference of the frame 106. As described below, the first connector 107A and the second connector 107B can be configured to mate with two corresponding recesses of the prosthetic retention member. Figures 1A to 1D In the embodiment, the rod 115A is longer than the rod 115B, and the rod 115A includes a curved portion 114A. 1 -114A 3 , while rod 115B does not include a bend. Thus, rod 115B may be substantially parallel to the central longitudinal axis of frame 106 when frame 106 is in the radially expanded configuration.

[0067] In another embodiment, the valve prosthesis of the embodiments herein may include a combination of connectors, each of which has at least one bend, or more specifically each of which is configured as a spring paddle. For example, FIG. 2A to FIG. 2B A valve prosthesis 201 is depicted, comprising Figure 1C The first connector 107A further includes a second connector 207B having a paddle 217B and connecting the paddle 217B to the end crown 103A. 1 -103A n The second connector 207B is located at Figure 2B, and may replace connector 107B, or may exist in addition to connector 107B. Like rod 115A of first connector 107A, rod 215B of second connector 207B has at least one bend 214B. FIG. 2A to FIG. 2B In the example of, the first connector 107A has a radiopaque marker 106A, while the connector 207B may not have a radiopaque marker. In some cases, the first connector 107A and the second connector 207B may have the same structure and / or the same size. For example, the rod 115A and the rod 215B may have the same shape and / or the same length. In other cases, the first connector 107A and the second connector 207B may have different structures and / or different sizes. For example, the rod 115A of the first connector 107A and the rod 215B of the second connector 207B may have different lengths.

[0068] As described above, the valve prosthesis (eg, 101 / 201 ) of the embodiments herein may be delivered to a treatment site via a delivery device, wherein the delivery device and the prosthesis may form a delivery system. Figure 3A and Figure 3B A side view of a delivery system 100 is shown, which includes a valve prosthesis 101 (see Figure 3B ) and a delivery device 110 configured to deliver the valve prosthesis 101 percutaneously to a treatment site. The delivery device 110 may include a shaft 132 on which the valve prosthesis 101 is mounted, and may include a sheath 112 for constraining the valve prosthesis 101 to a collapsed configuration and / or a partially expanded configuration. Figure 3A The configuration in which the balloon 120 is coupled to or formed by the distal end 116 of the sheath 112 and covers the valve prosthesis 101 and the shaft 132 is shown. Figure 3B The configuration is shown with balloon 120 retracted to a position where valve prosthesis 101 is exposed.

[0069] like Figure 3A and Figure 3BAs shown, the delivery device 110 may include a handle having at least one actuator, such as a first actuator 142 and a second actuator 144. The first actuator 142 may be configured to advance the shaft 132 distally from the insertion site to the treatment site in the patient (e.g., via the guidewire 109). The shaft 132 (also referred to as the inner shaft 132) may have a proximal end that terminates within the handle 140 and has a distal end 136. As described above, the valve prosthesis 101 may be mounted at the distal end of the shaft 132 during delivery and may be constrained to a delivery configuration, or more specifically a radially collapsed configuration, by a sheath 112 covering the valve prosthesis 101. In this case, the distal end 136 of the shaft 132 may be disposed within the sheath 112. More specifically, the distal portion 116 of the sheath 112 can define or can be coupled to a capsule 120 that can be configured to compressively hold the prosthetic valve 101 in a radially collapsed configuration to facilitate delivery to a desired treatment site. Because the sheath 112 can surround the shaft 132 and the valve prosthesis 101, the sheath 112 can also be referred to as an outer sheath. Further, because the shaft 132 is surrounded by the prosthetic valve 101 and the sheath 112, the shaft 132 can be referred to as an inner shaft.

[0070] The second actuator 144 may be configured to be parallel to the longitudinal axis L of the shaft 132. A The second actuator 144 is configured to manipulate the sheath 112 in a proximal direction, such as by sliding the sheath 112 (and therefore the capsule 120) relative to the shaft 132 and the valve prosthesis 101 to retract the sheath 112 in the proximal direction. More particularly, the second actuator 144 is coupled to the outer sheath 112 and is generally configured to provide for selective proximal retraction and distal advancement of the outer sheath 112 and the capsule 120 attached thereto relative to the valve prosthesis 101 maintained therein in a radially compressed delivery configuration for covering and uncovering the valve prosthesis 101. The second actuator 144 may take any configuration capable of providing the desired sheath actuation function, such as those described in U.S. Patent No. 8,579,963 to Tabor, assigned to the same assignee as the present disclosure and incorporated herein by reference in its entirety. Although outer sheath 112 is described herein as a single component, this is not meant to limit the design and outer sheath 112 may include multiple components, such as but not limited to a proximal shaft or other components suitable for the purposes described herein. Handle 140 may have any shape or size suitable for convenient manipulation by a user.

[0071] Figure 3C 1 is a perspective view of the distal portion of the delivery system 100, but for illustration purposes only, the outer sheath 112 is not shown. Figure 3CAs shown, the delivery system 100 can include a distal tip 133 or a tapered flexible nose cone coupled to a distal end 136 of the shaft 132. The inner shaft 132 can define a lumen enclosing the guidewire 109 so that the delivery system 100 can be slidably disposed over the guidewire 109 and tracked over the guidewire. Figure 3C Further illustrated is the lateral dimension of prosthesis 101 / frame 106 at first end 102 when valve prosthesis 101 / self-expanding frame 106 is in the collapsed configuration, the lateral dimension having a value r cc .

[0072] exist Figure 3B and Figure 3C In an embodiment, the shaft 132 can be coupled to the push shaft or intermediate member 122 at the prosthetic retention member 108. The push shaft 122 can be concentrically disposed on the inner shaft 132 and can have a proximal end and a distal end 126, the proximal end terminating within the handle 140 and the distal end being disposed within the outer sheath 112 when the outer sheath 112 is disposed on the valve prosthesis 101. The distal end 126 of the push shaft 122 may include a prosthetic retention member 108 that is configured to connect to or otherwise engage at least the connector 107A or other components of the valve prosthesis 101. In an embodiment, the prosthetic retention member 108 can be or can include a main shaft that is releasably coupled to a first end (e.g., 102) of the valve prosthesis 101. The main shaft can be a tubular member having at least a first recessed portion 111A formed on an outer surface thereof. More specifically, in this embodiment, although in Figure 3C Not shown in the figure, the prosthesis retaining member includes a first concave portion 111A and a second concave portion 111B (see Figure 7B ) for respectively securing the first connector 107A and the second connector 107B / 207B.

[0073] In the illustrated embodiment, first recessed portion 111A of prosthetic retention member 108 is configured to receive paddle 117A and / or rod 115A of connector 107A. More specifically, first recessed portion 111A may be configured to fit around paddle 117A and / or rod 115A to allow paddle 117A and / or rod 115A to mate with first recessed portion 111A. For example, Figure 4A prosthesis retaining member 408, or more particularly a spindle, which can be an embodiment of a prosthesis retaining member 108 is shown. Prosthesis retaining member 408 has a first recessed portion 411A. When valve prosthesis 101 is in a delivery configuration or in a partially deployed configuration, first connector 107A of prosthesis 101 can be connected to prosthesis retaining member 408. In this configuration, first paddle 117A can be disposed within first recessed portion 411A. More particularly, first recessed portion 411A can be assembled around first paddle 117A so that first paddle 117A cooperates with first recessed portion 411A.

[0074] exist Figure 4 In the embodiment of the present invention, the prosthesis retaining member 408 may further include a protruding portion 413A protruding from the surface thereof. The protruding portion 413A may be adjacent to the first and second rods 115A. 1 Arrange so that the paddle 117A is substantially aligned with the base of the spring, that is, the paddle is aligned with the bend 114A in the rod 115A. 2 and 114A 3 The protrusion 413A may act as a support protrusion that provides support for the first rod 115A at its base.

[0075] Figure 5 Another embodiment of a prosthetic retaining member 508, or more specifically a main shaft, is depicted that can be an embodiment of the prosthetic retaining member 108. The prosthetic retaining member 508 has a first recessed portion 511A and a second recessed portion 512A adjacent to the first recessed portion 511A. When the valve prosthesis 101 is in a delivery configuration or a partially deployed configuration, the first recessed portion 511A can receive the first paddle 117A, and the second recessed portion 512A can receive the first shaft 115A. More specifically, the first recessed portion 115A can be assembled around the first paddle 117A of the connector 107A so that the first paddle can cooperate with the first recessed portion 115A. The second recessed portion 512A can be shaped around the first shaft 115A (including the bend 114A of the first shaft 115A) 1 ) are assembled so that the first rod 115A can cooperate with the second recessed portion 512A.

[0076] In embodiments, prosthetic retaining member 408 / 508 may include a plurality of recessed portions for mating with a plurality of paddles of a plurality of connectors of a valvular prosthesis, wherein prosthetic retaining member 408 / 508 may include a corresponding recessed portion for each connector. For example, recessed portion 411A / 511A may be located on one side of prosthetic retaining member 408 / 508 and configured to mate with paddle 117A of connector 107A. Prosthetic retaining member 408 / 508 may further include a second recessed portion on an opposite side of first recessed portion 411A / 511A to mate with another paddle (e.g., Figure 1D paddle 117B of connector 107B, or Figure 2B As explained above, Figure 7B A second recess 111B is shown, which may be the recessed portion 411A or the recessed portion 511A.

[0077] As described above, the valve prostheses and delivery devices of the embodiments herein may facilitate accurate delivery and deployment to a treatment site. FIG. 6A to FIG. 9 An example method of delivering and deploying a valve prosthesis 101 via a delivery system 100 is shown. The delivery and / or deployment can be, for example, part of an interventional cardiology and / or interventional radiology procedure, wherein the delivery system 100, including a delivery device 110, is transluminally advanced through the vasculature in a retrograde approach to a treatment site, in this case, a target diseased native aortic valve AV extending between the patient's left ventricle LV and the patient's aorta A. Delivery of the delivery system 100 to the native aortic valve AV is accomplished via a percutaneous transfemoral approach, in which the delivery system is advanced through the femoral artery, up the aorta, and around the aortic arch in order to gain access to the native aortic valve AV. The delivery system 100 can also be positioned in a desired region of the heart via different delivery methods known in the art for accessing heart valves (e.g., via a direct aortic delivery method or a subclavian artery delivery method).

[0078] In an embodiment, the delivery system 100 follows over a guidewire 109 that has been previously inserted into the patient's vasculature. During delivery, the prosthetic valve 101 remains compressed within the balloon 120 of the outer sheath 112 as the delivery system 100 is manipulated and navigated through the vasculature. For example, Fig. 6A A balloon 120 is shown at the distal end of a sheath 112 covering a valve prosthesis 101, wherein the balloon 120 radially compresses or otherwise constrains the valve prosthesis 101 into a radially collapsed configuration. The delivery system 100 is advanced until its distal tip 133 is distal to the native aortic valve AV and disposed within the left ventricle LV (e.g., Fig. 6A), so that the second end 104 of the prosthesis 101 (when the valve prosthesis 101 is configured to be placed in the native aortic valve, the second end is the inflow end) is positioned at the annulus of the native aortic heart valve (as shown in Figure 6B shown).

[0079] Figure 6B A cross-sectional view of a native aortic heart valve AV is presented and depicts the second end 104 of the valve prosthesis 101 deployed at the annulus of the native aortic heart valve AV by proximal retraction of the outer sheath 112 and the balloon 120. The outer sheath 112 and the balloon 120 are proximally retracted via the second actuator 144 of the handle 140. Figure 6B The configuration depicted in FIG. 1 is a partially deployed configuration, but may also be referred to as an end crown 103A at the first end 102 of the frame 106. 1 -103A n The collapsed configuration at the end of the valve prosthesis 101 is still toward the end crown 103A at the first end 102 (eg, the outflow end) of the valve prosthesis 101. 1 -103A n Imposing restraint. Fig. 7A and Figure 7B The balloon 120 at the distal end 116 of the sheath 112 is depicted relative to Figure 6B The valve prosthesis 101 is further retracted after the retraction amount in. Fig. 7A and Figure 7B , valve prosthesis 101 / frame 106 is in a partially expanded configuration, wherein valve prosthesis 101 / frame 106 is more radially expanded, but end crown 103A of frame 106 at first end 102 of frame 106 is 1 -103A n The first end 102 is maintained in a radially collapsed configuration because the restraining force from the capsule 120 is still applied to the end crown 103A at the first end 102. 1 -103A n .like Figure 7B As shown, first paddle 117A may cooperate with recessed portion 111A of prosthetic retention member 108, and second paddle 117B may cooperate with recessed portion 111B of prosthetic retention member 108. Further, capsule 120 may further apply a restraining force to paddles 117A, 117B and rods 115A, 115B of connectors 107A, 107B. Still further, as Figure 7B As shown, the capsule 120 is directed toward the end crown 103A. 1 -103A n and the first end 102 of the prosthetic valve 101, thereby applying a restraining force to the end crown 103A. 1 -103A n Maintained in radially collapsed configuration.

[0080] As the outer sheath 112 and the balloon 120 continue to retract proximally, the balloon 120 no longer surrounds the end crown 103A. 1 -103A n , but continue to surround the paddles 117A, 117B disposed in the recessed portions 111A, 111B of the retaining member 108, such as Figure 8 Thus, in this partially deployed configuration, the outer sheath 112 / balloon 120 no longer covers the plurality of end crowns 103A. 1 -103A n Accordingly, from the end crown 103A 1 -103A n The restraining force is removed, thereby releasing them from the outer sheath 112 / balloon 120. Thus, the end crown 103A of the valve prosthesis 101 1 -103A n The self-expanding frame 106 can move outward due to its mechanical memory. However, because the outer sheath 112 / balloon 120 still covers the paddles 117A, 117B, and the paddles 117A, 117B are each connected to the end crown 103A, the outer sheath 112 / balloon 120 still covers the paddles 117A, 117B, and the paddles 117A, 117B are each connected to the end crown 103A. 1 -103A n One of the end crowns 103A 1 -103A n Therefore, Figure 8 In the embodiment, the end crown 103A 1 -103A n When the capsule 120 is further retracted to expose and release the paddles 117A, 117B, the restraining force is no longer applied to the paddles 117A, 117B, which can allow the valve prosthesis 101 to expand to the fully deployed configuration (in Fig. 9 ).

[0081] As mentioned above, one aspect of the present application relates to when the end crown 103A 1 -103A n When the corresponding position associated with the fully deployed configuration is reached, the kinetic energy level in the end crown is reduced. When the paddle 117A is released due to the retraction of the capsule 120, an end crown (such as the first end crown 103A) can be generated. k As described above, due to the mechanical memory of the self-expanding frame 106, the kinetic energy can be released by the end crown 103A. k If the end crown 103A is in the partially expanded configuration, k A relatively large amount of potential energy is stored, and when the paddle 117A is released and the end crown 103A is allowed to kWhen the frame 106 and the adjacent end crowns expand toward the fully deployed configuration, a relatively large amount of potential energy can be converted into a relatively high level of kinetic energy. Therefore, as further discussed above, the first rod 115A can be configured to provide the end crown 103A in the partially deployed configuration. k and the initial release of potential energy stored in the adjacent end crown, which can reduce the kinetic energy generated in the end crown as it moves toward the fully deployed position.

[0082] In an embodiment, the first rod 115A may be configured to allow the end crown 103A to be deployed while the frame 106 is still in the partially deployed configuration. k The first rod 115A may provide sufficient slack and / or deformability (or more specifically, stretchability) to allow the first end crown 103A to move outwardly and expand the frame 106 to provide an initial release of potential energy. k The first rod 115A and the adjacent end crowns move outwardly away from the paddle 117A to radially expand the first end 102 to a partially deployed configuration. As described above, the first rod 115A may include at least one bend that increases its overall length, wherein the increased length provides slack to enable the first end of the frame 106 to radially expand to a partially deployed configuration having a larger cross-sectional dimension than the same frame 106 with a shorter first stent. The expansion may radially expand the plurality of end crowns 103A at the first end 102 of the frame 106 in the partially deployed configuration. 1 -103A n The lateral dimension of the valve prosthesis 101 at pd As discussed further above, the first rod 115A may have a first value r associated with the partially deployed configuration. pd is the second value of the lateral dimension in the fully deployed configuration r fd In some cases, the first rod 115A can allow a first value r of the lateral dimension associated with the partially deployed configuration to be at least 70 percent of the lateral dimension associated with the partially deployed configuration. pd At a second value r of the lateral dimension of the self-expanding frame associated with the fully deployed configuration fd The range is between 80 and 90 percent.

[0083] Description of the terminal crown 103A 1 -103A n Another method of partially expanding the configuration is by expanding the crown 103A adjacent to the end 1 -103A n As described above, the frame 106 includes a terminal crown at each end of the frame. Further, the location where adjacent rows of struts 105 and crowns 103 of the frame 106 meet can be referred to as a node 121 (see Figures 1 and Figure 8 ).like Figure 8As shown, the frame 106 is adjacent to the endmost crown 103A. 1 -103A n The node 121 of the capsule 120 expands radially as the capsule 120 retracts proximally. Further, before the final release, the end crown 103A 1 -103A n The more radial expansion, the closer the framework is to the most distal crown 103A 1 -103A n Thus, in an embodiment, the framework 106 is in a partially expanded configuration (where the endmost crown 103A 1 -103A n The paddle is released from the capsule 120, but the paddle is still restrained by the capsule, the frame 106 is adjacent to the endmost crown 103A. 1 -103A n The cross-sectional dimension (eg, diameter or radius) at the node 121 of the embodiment is the diameter or radius of the node 121 adjacent to the endmost crown 103A in the fully deployed configuration. 1 -103A n At least 80% or at least 85% of the cross-sectional dimension at node 121.

[0084] Expanding the frame 106 to the partially deployed configuration releases some of the potential energy stored by the frame 106, including the potential energy stored by the end crowns 103A. 1 -103A n Thus, when the capsule 120 is retracted in the proximal direction past the paddles 117A / 117B and the prosthetic retaining component 108, the end crown 103A 1 -103A n can move towards Fig. 9 As a result, the end crown 103A 1 -103A n No oscillation or reduced / limited oscillation occurs when they reach the position associated with the fully deployed configuration. No oscillation / limited oscillation can better ensure that the valve prosthesis 101 does not deviate from the desired depth in the annulus of the native aortic heart valve. Further, due to the storage of the end crown 103A before final deployment 1 -103A n There is less potential energy at the first end 102 of the frame, so when the paddles 117A / 117B are released from the capsule 120, there is less tendency for the first end 102 of the frame to "jump".

[0085] As described above, self-expanding frame 106 of valve prosthesis 101 can store potential energy in the collapsed configuration, and expansion of self-expanding frame 106 from the collapsed configuration to the partially expanded configuration can release a portion of the stored potential energy. Further, rod 115A of connector 107A can have a length that allows a large amount of expansion to occur, which can allow a large portion of the stored potential energy to be consumed by expanding from the collapsed configuration to the partially expanded configuration. For example, Fig.10 A graph illustrating the amount of strain potential energy stored by self-expanding frame 106 of valve prosthesis 101 is provided. 1 -103A n When released by the balloon 120, the frame 106 can store about 50 mJ of strain potential energy. 1 -103A n However, when blades 117 / A / 117B are still restrained (e.g. Figure 8 ), the strain potential energy is reduced by about 40 percent, from about 50 mJ to about 30 mJ. In some cases, the strain potential energy may be reduced by at least 50 percent. 1 -103A n This reduction in stored potential energy may result in a reduction in the kinetic energy of the end crowns when expanding the frame 106 to the fully deployed configuration.

[0086] As an example of controlling the kinetic energy of the end crown, Fig.11 An end crown 103A depicting a valve prosthesis 101 is provided. 1 -103A n The curve diagram shows the kinetic energy at the end crown 103A. 1 -103A n End crown 103A when released by capsule 120 but paddles 117A / 117B remain restrained by capsule 120 1 -103A n has a first level of peak kinetic energy, and when the blades 117A / 117B are released and the end crown 103A 1 -103A n The end crown has a second level of peak kinetic energy when allowed to fully expand radially. Fig.11 In the example shown in FIG. 1 , the peak kinetic energy of the first level may be in the range of 20 mJ to 25 mJ (e.g., 21 mJ), and the peak kinetic energy of the second level may be in the range of 5 mJ to 20 mJ, or more specifically in the range of 10 mJ to 15 mJ (e.g., 12.6 mJ). More specifically, the rod 115A in the present application may be connected to the end crown 103A. 1 -103A nThe second level of peak kinetic energy associated with expansion to the fully deployed configuration does not exceed the peak kinetic energy of the distal crown 103A. 1 -103A n 60 or 70 percent of the first level of peak kinetic energy associated with expansion from the radially compressed configuration to the partially expanded configuration. This reduced value of the second level of peak kinetic energy can aid in accurate deployment of valve prosthesis 101 by reducing jumps and oscillations as described above.

[0087] The foregoing description of the present invention is given for illustration and practice, and is not intended to be exhaustive or to limit the present invention to the precise form disclosed. In view of the teachings of the above, other modifications and variations are possible. These embodiments are selected and described to clearly explain the principles of the present invention and their practical applications, so that those skilled in the art can best utilize the present invention, and various embodiments with various modifications are suitable for the specific application under consideration. The attached claims are interpreted to include other alternative embodiments of the present invention.

Claims

1. A valve prosthesis, comprising: A self-expanding frame comprising: (i) a plurality of struts forming a plurality of end crowns at a first end of the self-expanding frame; and (ii) a first paddle connected to a first end crown of the plurality of end crowns by a first rod, Wherein, the self-expanding frame: capable of collapsing at the first end of the self-expanding frame to a collapsed configuration when a restraining force is applied to the first paddle and the plurality of end crowns, configured to expand from the collapsed configuration to a partially deployed configuration when the restraining force is removed from the plurality of end crowns but still applied to the first paddle, wherein in the partially deployed configuration, the self-expanding frame has a first value of a lateral dimension at the first end, and configured to expand from the partially deployed configuration to a fully deployed configuration when the restraining force is removed from the plurality of end crowns and from the first paddle, wherein, in the fully deployed configuration, the self-expanding frame has a second value of the lateral dimension at the first end, wherein the first value is at least 70 percent of the second value; and A prosthetic valve component is coupled to the interior of the self-expanding frame.

2. The valve prosthesis according to claim 1, wherein: The first value of the lateral dimension is within a range of 80 percent to 90 percent of the second value of the lateral dimension.

3. The valve prosthesis according to claim 1, wherein: In the collapsed configuration, the plurality of end crowns store potential energy, and when the self-expanding frame expands from the collapsed configuration to the partially-expanded configuration, the stored potential energy decreases by at least 40 percent.

4. The valve prosthesis according to claim 3, wherein: When the self-expanding frame expands from the collapsed configuration to the partially deployed configuration, the stored potential energy decreases by at least 50 percent.

5. The valve prosthesis according to claim 1, wherein: The self-expanding frame disperses a first level of peak kinetic energy when expanding from the collapsed configuration to the partially expanded configuration, and disperses a second level of peak kinetic energy when expanding from the partially expanded configuration to the fully expanded configuration, and wherein the second level of peak kinetic energy is less than 70 percent of the first level of peak kinetic energy.

6. The valve prosthesis according to claim 5, wherein: The second level of peak kinetic energy is in the range of 5 millijoules (mJ) to 20 mJ.

7. The valve prosthesis according to claim 6, wherein: The second level of peak kinetic energy is in the range of 10 mJ to 15 mJ.

8. The valve prosthesis according to claim 1, wherein: The first rod has a length of at least 4 mm.

9. The valve prosthesis according to claim 1, wherein: The first rod is formed as a spring having a plurality of bends, and the spring is stretched when the self-expanding frame expands from the collapsed configuration to the partially deployed configuration.

10. The valve prosthesis according to claim 9, wherein: The spring has a spring constant in the range of 0.2 N / mm to 5 N / mm.

11. The valve prosthesis according to claim 1, wherein: When the first end is in the radially collapsed configuration, the first rod has at least one bend connecting a first segment of the first rod and a second segment of the first rod, the first segment extending from the first end crown, and the second segment extending to the first blade, wherein a gap between the first segment and the second segment is less than 1 mm.

12. The valve prosthesis of claim 1, further comprising a second paddle connected to a second end crown of the plurality of end crowns via a second rod, the first paddle and the second paddle being located on opposite sides of the first end of the self-expanding frame.

13. The valve prosthesis according to claim 12, wherein: The first rod and the second rod have different lengths.

14. The valve prosthesis according to claim 12, wherein: The first rod and the second rod are substantially equal in length.

Images