Heart valve prosthesis

Abstract

The present invention discloses an artificial heart valve device for percutaneous heart valve replacement and related methods. A transcatheter valve prosthesis (100) configured according to this method includes a frame (100) having a valve support structure (120) and one or more support arms (140) coupled thereto. When the valve prosthesis is in an expanded configuration, the one or more support arms are configured to extend from the second end of the valve support structure toward the first end. When deployed in the expanded configuration, the one or more support arms have a curved shape, such as a generally S-shape, at least partially engaging with tissue at the natural heart valve.

Description

[0001] This invention patent application is a divisional application of the invention patent application with international application number PCT / US2016 / 055585, international application date October 5, 2016, application number 201680058947.5 entering the Chinese national phase, and name “Heart Valve Prosthesis”. Technical Field

[0002] The present technology generally relates to heart valve prostheses and related methods. In particular, several embodiments relate to transcatheter heart valve devices for percutaneous replacement of native heart valves, such as the mitral valve. Background Art

[0003] The human heart is a four-chambered muscular organ that provides blood circulation throughout the body during the cardiac cycle. The four main chambers include the right atrium and right ventricle that provide pulmonary circulation, and the left atrium and left ventricle that provide oxygenated blood received from the lungs to the rest of the body. To ensure that blood flows in one direction along the heart, the atrioventricular valves (tricuspid and mitral valves) are present at the junction of the atria and ventricles, and the semilunar valves (pulmonary and aortic valves) control the outlet of the ventricles to the lungs and the rest of the body. These valves contain leaflets that open and close in response to changes in blood pressure caused by the contraction and relaxation of the ventricles. The leaflets separate from each other to open and allow blood to flow downstream of the valve, and engage with each other to close and prevent backflow or reflux in an upstream manner.

[0004] Diseases related to heart valves, such as those caused by injury or defects, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve that prevents blood from flowing to the downstream ventricle to narrow and stiffen in order for proper flow to occur and causes the heart to work harder to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, resulting in a reduced efficiency of the heart. Diseased or damaged valves that are congenital, age-related, drug-induced, or in some cases caused by infection can cause an enlarged, thickened heart that loses its elasticity and efficiency. Some symptoms of valvular heart disease include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots that increase the likelihood of a stroke or pulmonary embolism. Symptoms are often severe enough to be debilitating and / or life-threatening.

[0005] Artificial heart valves have been developed for repairing and replacing diseased and / or damaged heart valves. Such valves can be delivered percutaneously by a catheter-based system and deployed at the site of the diseased heart valve. Such artificial heart valves can be delivered in a low profile or compressed / contracted arrangement so that the artificial valve can be accommodated in the sheath assembly of the delivery catheter and advanced through the patient's vascular system. Once positioned at the treatment site, the artificial valve can be expanded to engage the tissue at the diseased heart valve area, so that, for example, the artificial valve is maintained in place. Although these artificial valves provide minimally invasive methods for heart valve repair and / or replacement, there is still a challenge to provide such an artificial valve that prevents leakage (paravalvular leakage) between the implanted artificial valve and the surrounding tissue and prevents the movement and / or migration of the artificial valve that may occur during the cardiac cycle. For example, there are many challenges in the mitral valve, such as displacement or improper arrangement of the artificial valve caused by the presence of chordae tendinae and residual leaflets, resulting in the impact of the valve. Additional challenges may include providing an artificial valve to resist the distorting forces imparted by the native anatomy and the premature failure of various components that may occur during the cardiac cycle. Further anatomical challenges associated with mitral valve treatment include providing an artificial valve that accommodates an elliptical or kidney shape. In addition, the kidney-shaped mitral annulus has muscle only along the outer wall of the valve, which has only a thin vessel wall separating the mitral valve and the aortic valve. This anatomical muscle distribution, as well as the high pressures experienced by the left ventricle during contraction, can be problematic for mitral valve prostheses. Summary of the invention

[0006] Embodiments of the present invention relate to heart valve prostheses and methods for percutaneous implantation thereof. The heart valve prosthesis has a compressed configuration for delivery to a patient's native heart valve via the vasculature or other body cavity; and an expanded configuration for deployment within the native heart valve. In one embodiment, the heart valve prosthesis may include: a frame having a valve support structure configured to retain an artificial valve assembly therein; and a plurality of support arms extending from the valve support structure such that when the heart valve prosthesis is in the expanded configuration, the plurality of support arms are configured to extend toward a first end of the valve support structure to engage a subannular surface of the native heart valve. One or more of the plurality of support arms include a curved support arm formed to have a first arcuate region and a second arcuate region relative to each other, the first arcuate region and the second arcuate region being longitudinally separated by a straight region extending therebetween, wherein the first arcuate region is formed to be inclined toward a valve support structure near its downstream portion, the straight region is formed to be inclined toward the valve support structure when connecting the first arcuate region and the second arcuate region, and the second arcuate region is formed to bend away from the valve support structure near its upstream portion.

[0007] In another embodiment, a heart valve prosthesis for implantation in a native valve region of a heart includes a valve support structure having an upstream portion and a downstream portion, the valve support structure being configured to hold an artificial valve assembly therein and having a plurality of support arms extending from the downstream portion of the valve support structure. When the heart valve prosthesis is in an expanded configuration, each support arm is configured to extend from the downstream portion toward the upstream portion and has a curved shape including a first curved region having a first radius of curvature, a second curved region having a second radius of curvature, and an elongated region extending between the first curved region and the second curved region. In such a support arm, the curved shape is configured to absorb twisting forces exerted thereon by the native valve region.

[0008] In another embodiment, a heart valve prosthesis for treating a patient's natural mitral valve is disclosed. The heart valve prosthesis includes a cylindrical support structure having an upstream portion, a downstream portion, and a first cross-sectional dimension, wherein the cylindrical support structure is configured to hold an artificial valve component that inhibits retrograde blood flow. A plurality of S-shaped support arms extend from the downstream portion of the cylindrical support structure, such that when the heart valve prosthesis is in an expanded configuration, the S-shaped support arms are configured to extend in an upstream direction to engage heart tissue above or below the annulus of the natural mitral valve. A radially extending segment extends from the upstream portion of the cylindrical support structure and has a second cross-sectional dimension that is greater than the first cross-sectional dimension. The radially-extending segment is configured to engage heart tissue above or above the natural mitral valve, such that when the heart valve prosthesis is in an expanded configuration and is deployed at the natural mitral valve, the annulus is positioned between the upstream curved segment and the radially extending segment of the S-shaped support arm. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The above and other features and aspects of the present invention can be better understood from the following description of the embodiments and the accompanying drawings. The accompanying drawings are incorporated herein and constitute a part of the specification, and are further used to illustrate the principles of the present technology. The components in the drawings are not necessarily drawn to scale.

[0010] Figure 1 is a schematic cross-sectional view of a mammalian heart with a native valve structure.

[0011] Figure 2A is a schematic cross-sectional illustration of the left ventricle of a mammalian heart showing the anatomy and native mitral valve.

[0012] Figure 2B is a schematic cross-sectional illustration of a left ventricle of a heart having a prolapsed mitral valve wherein the leaflets are inadequately coapted and suitable for replacement with various embodiments of a prosthetic heart valve in accordance with the present technology.

[0013] Figure 3 is a schematic diagram of the top view of the mitral valve isolated from the surrounding heart structures and showing the annulus and native leaflets.

[0014] Figure 4A is a side view of a heart valve prosthesis in an expanded or expanded configuration (e.g., an expanded state) according to an embodiment of the present technology.

[0015] Figure 4B According to an embodiment of the present technology Figure 4A Top view of a heart valve prosthesis.

[0016] Figure 4C is along Figure 4AA top view of a heart valve prosthesis taken along line 4C-4C according to an embodiment of the present technology.

[0017] Figure 5A A cross-sectional view of a heart is shown, showing a partial side view of a heart valve prosthesis implanted at a native mitral valve in accordance with an embodiment of the present technology.

[0018] Figure 5B is an expanded configuration (e.g., expanded state) according to an embodiment of the present technology Figure 5A An enlarged cross-sectional view of a heart valve prosthesis.

[0019] Figure 5C is an enlarged cross-sectional view of a portion of a heart valve prosthesis shown in an expanded configuration (eg, expanded state) in accordance with another embodiment of the present technology.

[0020] Figures 6A-6C are side views of various support arm configurations according to additional embodiments of the present technology.

[0021] Figure 7 is a partial side view of a heart valve prosthesis showing multiple flexible areas on a support arm in accordance with an embodiment of the present technology.

[0022] Figures 8A-8H is a side view of various support arms bending in response to twisting forces according to other embodiments of the present technology.

[0023] Fig. 9 1 is shown in a delivery configuration (e.g., a low profile or radially compressed state) according to an embodiment of the present technology Figure 5A-5B An enlarged cross-sectional view of a heart valve prosthesis in FIG.

[0024] Fig.10 is a cross-sectional view of a heart illustrating steps of a method for implanting a heart valve prosthesis using a transseptal approach according to another embodiment of the present technology. DETAILED DESCRIPTION

[0025] Specific embodiments of the present technology are described below with reference to the accompanying drawings, in which like reference numerals indicate identical or functionally similar components. The terms "distal" and "proximal" are used in the following descriptions of positions or directions relative to a treating clinician or with respect to an artificial heart valve device. For example, "distal" or "distally" is a position away from the clinician or in a direction away from the clinician when referring to a delivery procedure or along the vascular system. Similarly, "proximal" or "proximally" is a position close to the clinician or in a direction toward the clinician. Relative to an artificial heart valve device, the terms "proximal" and "distal" can refer to the positions of multiple portions of the device relative to the direction of blood flow. For example, the proximal end can refer to an upstream position or a position where blood flows in, and the distal end can refer to a downstream position or a position where blood flows out.

[0026] The following detailed description is merely exemplary in nature and is not intended to limit the technology or the application and application of the technology. Although the description of the embodiments of the present invention is carried out in the context of treatment of heart valves, especially the mitral valve, the technology can also be used in any other body channel that is considered useful. In addition, there is no intention to be bound by any express or implied theory presented in the aforementioned technical field, background technology, invention content or the following detailed description.

[0027] Embodiments of the present technology as described herein can be combined in many ways to treat one or more of the many valves of the body, including heart valves, such as the mitral valve. Embodiments of the present technology can be therapeutically combined with many known procedures and steps, for example, such embodiments can be combined with known methods of accessing heart valves (such as the mitral valve with antegrade or retrograde approaches) and combinations thereof.

[0028] Figure 1 is a schematic cross-sectional view of a mammalian heart 10 depicting the four heart chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and native valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV). Figure 2A is a schematic cross-sectional view of the left ventricle LV of a mammalian heart 10 showing the anatomical structure and the native mitral valve MV. Figure 1 and Figure 2A , the heart 10 includes a left atrium LA that receives oxygenated blood from the lungs via the pulmonary veins. During ventricular diastole, the left atrium LA pumps oxygenated blood through the mitral valve MV and into the left ventricle LV. During systole, the left ventricle LV contracts and blood flows outward through the aortic valve AV into the aorta and the rest of the body.

[0029] In a healthy heart, the leaflets LF of the mitral valve MV meet or "coapt" evenly at their free edges to close and prevent backflow of blood during left ventricle LV systole ( Figure 2A). refer to Figure 2A , the leaflets LF are attached to the surrounding cardiac structures via a fibrous ring of connective tissue called the annulus AN. The flexible leaflet tissue of the mitral valve leaflets LF is connected to the papillary muscles PM, which extend upward from the inferior wall of the left ventricle LV and the interventricular septum IVS by branching tendons called chordae tendineae CT. In a heart 10 with a prolapsed mitral valve MV in which the leaflets LF are not adequately coapted or met, as Figure 2B As shown, leakage from the left ventricle LV into the left atrium LA will occur. Several structural defects can lead to mitral valve leaflet LF prolapse and regurgitation including chordae tendineae CT rupture, papillary muscle PM injury (eg, due to ischemic heart disease), and enlargement of the heart and / or mitral annulus AN (eg, arrhythmias).

[0030] Figure 3 is a top view of the mitral valve MV isolated from the surrounding heart structures, and further illustrates the shape and relative sizes of the leaflets LF and the annulus AN. As shown, the mitral valve MV generally has a "D" or kidney shape. The mitral valve MV includes an anterior leaflet AL, which, when closed, meets the posterior leaflet PL at the commissure line. When the anterior leaflet AL and the posterior leaflet PL fail to meet, regurgitation may occur at the commissure C between the leaflets AL, PL or at the corner between the leaflets.

[0031] Embodiments of prosthetic heart valve devices and related methods according to the present technology are described in this section with reference to Figure 4A-10 It should be understood that the specific components, substructures, uses, advantages and / or other aspects of the embodiments described herein and the references Figure 4A-10 , additional embodiments according to the present technology may be interchanged, replaced or otherwise configured as appropriate.

[0032] The present invention provides systems, devices and methods for percutaneously delivering and implanting artificial heart valves in a patient's heart. In some embodiments, methods and devices for treating valvular disease by minimally invasive implantation of an artificial or prosthetic heart valve are presented. For example, an artificial heart valve device according to embodiments described herein can be implanted to replace a patient's (e.g., Figure 2A In one embodiment, the device is suitable for implanting and replacing a diseased or damaged native mitral valve or a previously implanted artificial mitral valve in a patient with a prolapsed mitral valve (shown in FIG. 1 ). In further embodiments, the device is suitable for implanting and replacing other diseased or damaged heart valves or previously implanted artificial heart valves, such as tricuspid, pulmonary and aortic heart valves.

[0033] Figure 4A is a side view of a heart valve prosthesis or artificial heart valve device 100 in a radially expanded or deployed configuration (e.g., a deployed state) in accordance with an embodiment of the present technology. Figure 4B Yes Figure 4A and Figure 4C A top view of the heart valve prosthesis 100 configured in FIG. Figure 4C It is along Figure 4A A top view of the prosthesis 100 taken along line CC. Figures 4A-4C As shown, the heart valve prosthesis 100 includes a frame or stent-like support structure 110, which includes a tubular portion or structural valve support structure 120, which defines a lumen 121 for retaining, holding and / or fixing an artificial valve component 130 therein. The valve support structure 120 can be generally cylindrical, having a longitudinal axis L along the valve support structure 120. A The upstream portion 124 at the first end 125 and the downstream portion 126 at the second end 127 are oriented Figure 4A ). The frame 110 further includes one or more support arms 140 that extend radially outward from the valve support structure 120 and generally in an upstream direction of the downstream portion 126 of the valve support structure 120 (e.g., reaching behind the native leaflets of the mitral valve and engaging cardiac tissue in the subannular region within the left ventricle). At least some of the support arms 140 can have a curved shape 141 that is configured to atraumatically engage the native annulus and substantially absorb torsional forces such that the prosthesis 100 is supported by the annulus when the prosthetic valve assembly 130 is closed during systole.

[0034] In some embodiments, Figure 4A As shown in the radially expanded configuration, the frame 110 further includes a radially extending section or radially extending portion 150 that at least partially surrounds the valve support structure 120 and extends from the upstream portion 124 of the valve support structure 120. The radially extending section 150 may include a plurality of self-expanding struts 152 that are configured to expand radially when the prosthesis 100 is deployed to the expanded configuration. In some arrangements, the radially extending section 150 can be engaged to the annulus or to tissue above the annulus when implanted in the native mitral valve space. In this embodiment, the radially extending section 150 can maintain the valve support structure 120 in a desired position within the native valve region (e.g., between the native leaflets and the annulus of the mitral valve). Reference Figure 4B As shown, the radially extending segment 150 and / or the valve support structure 120 may include a sealing material 160 that may surround an upper or upstream surface 154 or a lower or downstream surface 155 of the radially extending segment 150 ( Figure 4A ) extends around the inner wall 122 or outer wall 123 of the valve support structure 120 to prevent blood leakage (e.g., paravalvular leakage) between the implanted prosthesis 100 and the native heart tissue.

[0035] refer to Figure 4B, showing that the radial extension 150 and the valve support structure 120 have a generally circular cross-sectional shape, wherein the cross-sectional dimension D1 of the radial extension 150 is greater than the cross-sectional dimension D2 of the valve support structure 120. In some embodiments, the radial extension 150, the valve support structure 120, or both may have other cross-sectional shapes to accommodate a D-shaped or kidney-shaped mitral valve. For example, the radial extension 150 and / or the valve support structure 120 may be expanded into an irregular, non-cylindrical, or elliptical configuration for accommodating a mitral valve or other valve. In addition, native valves (e.g., mitral valves, aortic valves) may have unique sizes and / or other unique anatomical shapes and features that vary from patient to patient, and the prosthesis 100 used to replace or repair such valves may be adapted to accommodate the size, geometry, and other anatomical features of such native valves. For example, the radial extension 150 may expand within the region of the native heart valve while being flexible so as to conform in shape to the region to which the radial extension 150 engages.

[0036] Figure 4A and 4B A radially extending segment 150 is shown having a plurality of struts 152 extending outwardly from the outer wall 123 at the first end 125 of the valve support structure 120. In one embodiment, the struts 152 are relatively evenly arranged around the circumference of the valve support structure 120, and each strut 152 connects adjacent struts 152 at a crown 156. In one embodiment, the crown 156 has an atraumatic tip 157 that prevents damage to cardiac tissue during deployment and through the cardiac cycle. Examples of suitable radially extending segments 150 are described in U.S. Patent Publication No. 2015 / 0119982, the entire contents of which are incorporated herein by reference.

[0037] Refer to Figure 4A and 4C , a plurality of support arms 140 extend from the downstream portion 126 of the valve support structure 120 and are spaced approximately evenly around the circumference of the outer wall 123 of the valve support structure 120 ( Figure 4C ). In alternative arrangements not shown, the support arms 140 may be unevenly spaced, grouped, irregularly spaced, etc. around the circumference. In a particular example, the support arms 140 may be grouped more closely together and extend from the valve support structure 120 at locations that are generally aligned with the anterior and posterior leaflets of the mitral valve when deployed. Figure 4C The illustrated embodiment has twelve support arms 140 evenly spaced around the circumference of the valve support structure 120. In alternative arrangements, the prosthesis 100 can include fewer than twelve support arms 140, such as two support arms, two to six support arms, more than six support arms, nine support arms, etc., or more than twelve support arms 140.

[0038] refer to Figure 4A , the support arm 140 can extend from the valve support structure 120 at or near the second end 127 and can be described as extending generally along or parallel to the outer wall 123 of the valve support structure 120 toward the upstream portion 124. As shown, the support arm 140 can have a generally curvilinear shape 141 or a similar geometric shape. The curvilinear shape 141 includes opposing arcuate or curved regions 142, 144 that are longitudinally separated by an inclined elongated or straight region 143 extending therebetween. When positioned for use with a native mitral valve, the arcuate region 142 of the curvilinear support arm 140 can be referred to as a downstream curved segment 142, and the arcuate region 144 of the curvilinear support arm 140 can be referred to as an upstream curved segment 144.

[0039] In some embodiments, the curved shape 141 includes a first arcuate (e.g., curved) region 142 that is formed to bend in a direction toward the outer wall 123 to engage a portion of at least one leaflet of a native heart valve or other structures in the heart valve region, such as chordae tendinae. In one embodiment, the first arcuate region 142 may extend around the downstream edge of the native valve leaflet. In a middle portion of the support arm 140, the support arm includes a straight region 143 that is configured to follow the first arcuate region 142 and be inclined in a direction toward the outer wall 123 at a middle or central portion 170 of the valve support structure 120. At a free end portion of the support arm 140 near the first end 125 of the valve support structure 120, the support arm 140 also includes a second arcuate (e.g., curved) region 144 that follows the straight or elongated region 143 along the curved shape 141 and is formed to bend in a direction away from the outer wall 123 of the valve support structure 120 and engage tissue at or near the native heart valve when implanted. In one particular example, the second arcuate region 144 can atraumatically engage the annulus tissue and / or a portion of a heart chamber wall (eg, a ventricular wall). Figure 4A In certain embodiments, the first arcuate region 142 is longitudinally separated from the second arcuate region 144 by a straight line or elongated region 143 to form or define a generally S-shaped profile.

[0040] In such Figure 4A and Figure 4CIn the illustrated embodiment, the second arcuate region 144 on each support arm 140 provides or defines a contact surface or landing zone 145 that is configured to engage tissue in an atraumatic manner at or near the subannular tissue to inhibit tissue erosion and / or resist movement of the prosthesis 100 in an upstream direction during ventricular systole, as further described below. As shown, the second arcuate region 144 includes a widened and / or flattened portion 446 that forms the landing zone 145. Figure 4A As shown, the widened portion 446 has a first width W1 that is greater than the width W2 of the first arcuate region 142 of the support arm 140. When the prosthesis 100 is deployed and contacts tissue (e.g., subannular tissue, native valve leaflets, ventricular wall, etc.) through the widened portion 446, the landing zone 145 effectively distributes the native tissue contact over a larger surface area to inhibit tissue erosion and distribute the load stress on these support arms 140. Figure 4A and 4C In the illustrated embodiment, the landing zone 145 includes a groove 447 formed along the widened portion 446, which can provide an additional barrier to prevent the landing zone 145 from moving relative to the contacted tissue. In alternative arrangements, the landing zone 145 may include raised portions, protrusions, cut-outs, and other features that provide additional resistance to movement of the contacted tissue once deployed. In various arrangements, by resisting movement of the landing zone 145 against the contacted natural tissue, the support arm 140 provides atraumatic contact in a manner that limits or inhibits tissue erosion and / or wear after implantation of the prosthesis 100. In certain embodiments, and as Figure 4A and 4C As shown, the support arm 140 includes an arm tip 148, which may be rounded or otherwise shaped to prevent trauma to cardiac tissue engaged by the arm tip 148 during deployment or when fully implanted. In the illustrated embodiment, the arm tip 148 includes a hole 448 for attaching the support arm 140 to a delivery catheter (not shown) in a radially compressed configuration for delivery to a target site. Additionally or alternatively, one or more holes 448 may be filled with a secondary material (e.g., tantalum, platinum, gold) to improve visibility during fluoroscopic guided delivery. In an alternative arrangement, the support arm 140 may not include the hole 448 and / or other landing zone features (e.g., groove 447) without departing from the scope of the present invention.

[0041] In some embodiments described herein, in order to switch between an initial compressed configuration (e.g., in a delivery state, not shown) and an expanded configuration ( Figure 4A), or self-expanding, the frame 110 is formed of an elastic or shape memory material such as a nickel-titanium alloy (e.g., Nitinol) that has a mechanical memory to return to the deployed or expanded configuration. In one embodiment, the frame 110 can be a unitary structure that defines a radial extension 150 at the inflow portion of the prosthesis 100, the valve support structure 120, and the plurality of support arms 140, and the frame 110 described thus can be made of stainless steel, a pseudo-elastic metal such as a nickel-titanium alloy or Nitinol, or a so-called superalloy. In some arrangements, the frame 110 can be formed as a unitary structure, for example, from a laser-cut, fenestrated Nitinol or other metal tube. Mechanical memory can be imparted to the structure forming the frame 110 by heat treatment to achieve spring tempering in stainless steel, for example, or to set shape memory in a sensitive metal alloy (e.g., Nitinol). The frame 110 can also include a polymer or a combination of metals, polymers, or other materials.

[0042] In one embodiment, the frame 110 can be a flexible metal frame or support structure having a plurality of ribs and / or struts (e.g., struts 128, 152) arranged geometrically to provide radial compression (e.g., in a delivery state, not shown) that can be used for delivery to a target native valve site and radial expansion (e.g., to a position where the septum is positioned) that can be used for deployment and implantation at the target native valve site. Figure 4A The radially expanded configuration shown in FIG. Figure 4A The valve support structure 120 shown, the ribs and struts 128 can be arranged in a plurality of geometric patterns, which can expand or bend and contract while providing sufficient flexibility and strength to maintain the integrity of the artificial valve assembly 130 encapsulated therein. For example, the struts 128 can be arranged around the longitudinal axis L A Arranged in a circular pattern, wherein the circular pattern comprises a series of diamonds, sawtooths, sinusoids, or other geometric shapes.

[0043] In other embodiments, the frame 110 can include separately manufactured components that are docked, connected, welded, or otherwise mechanically connected to each other to form the frame 110. For example, the radially extending segment 150 can be docked to the upstream portion 124 of the valve support structure (e.g., at an attachment point 129a on a strut 128 defined by the diamond geometry of the valve support structure 120). Similarly, the support arm 140 can be coupled to the downstream portion 126 of the valve support structure 120 (e.g., at an attachment point 129b on a strut 128 defined by the diamond geometry of the valve support structure 120). Other arrangements and attachment points are contemplated for docking one or more support arms 140 and radially extending segments 150 to the valve support structure 120. In certain embodiments, such as Figure 4AAs shown, the support arm 140 can be docked to the valve support structure 120 via the arm post 146. In one embodiment, the arm post 146 can be integral with the frame 110, such that the arm post 146 is an extension of one or more struts 128. In another embodiment, the arm post 146 and the valve support structure 120 can be docked by various methods known in the art, such as welding, welding, bonding, rivets or other fasteners, mechanical interlocking, or any combination thereof. In one embodiment, the valve support structure 120 can be a balloon expandable tube metal stent, and the radial extension section 150 of the frame 110 and the support arm 140 can be formed by materials and methods to self-expand as described above. In another embodiment related hereto, without departing from the scope of the present invention, the support arm 140 can extend from or dock to the middle or central portion 170 of the valve support structure 120.

[0044] refer to Figure 4B-4C , a prosthetic valve assembly 130 can be docked to the inner wall 122 of the valve support structure 120 for controlling blood flow through the heart valve prosthesis 100. For example, the prosthetic valve component 130 can include a plurality of leaflets 132 (shown individually at 132a-b) that engage and are configured to allow blood to flow through the prosthesis 100 in a downstream direction (e.g., from the first end 125 to the second end 127) and inhibit blood from flowing in an upstream direction (e.g., from the second end 127 to the first end 125). Although the prosthetic valve assembly 130 is shown as having a bicuspid arrangement, it should be understood that the prosthetic valve assembly 130 can have three leaflets 132 (tricuspid arrangement, not shown) or more than three leaflets 132 to engage to close the prosthetic valve assembly 130. In one embodiment, the leaflets 132 can be mounted on the inner wall 122 of the valve support structure 120 from bovine pericardium or other natural materials (e.g., obtained from human or animal heart valves, aortic roots, aortic walls, aortic valve leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosa tissue, umbilical cord tissue, etc.). In another embodiment, synthetic materials suitable for use as the leaflets 132 include: Polyester (commercially available from Inwinster North America, Inc., Wilmington, Delaware), other cloths, nylon blends, polymer materials, and vacuum deposited nitinol welded materials. In yet another embodiment, the leaflet 132 can be made of an ultra-high molecular weight polyethylene material commercially available from Royal DSM of the Netherlands under the trade name DYNEEMA. For certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that prevents or minimizes overgrowth. It may be further desirable that the leaflet material be durable and not affected by stretching, deformation, or fatigue.

[0045] Figure 5A is a schematic diagram showing a partial side view of a prosthesis 100 implanted in the native mitral valve region of a heart 10 according to an embodiment of the present technology. Figure 5A The prosthesis 100 shown in the figure has only two support arms 140 for illustrative purposes only. It will be appreciated that the prosthesis 100 can have more than two support arms 140 in some arrangements, such as more than six support arms, etc. Typically, when implanted, the upstream portion 124 of the valve support structure 120 is oriented to receive blood inflow from a first heart chamber (e.g., the left atrium LA for mitral valve MV replacement, the left ventricle for aortic valve replacement, etc.), and the downstream portion 126 is oriented to release blood outflow to a second heart chamber or structure (e.g., the left ventricle LV for mitral valve MV replacement, the aorta for aortic valve replacement).

[0046] In operation, the heart valve prosthesis 100 can be delivered intravascularly in a radially compressed configuration (not shown) and within a delivery catheter (not shown) to a desired native valve region of the heart 10, such as near the mitral valve MV. Figure 5A , the prosthesis 100 can be advanced to a position within or downstream of the native mitral annulus AN, wherein the support arms 140 and downstream portion 126 of the valve support structure 120 are released from the delivery catheter. The delivery catheter can then release the upstream portion 124 and radial extension 150 of the valve support structure 120 at a position within or upstream of the native mitral valve MV so as to expand toward a radially expanded configuration and engage native tissue in the region of the native heart valve. Once released from the delivery catheter, the prosthesis 100 can be positioned such that the radial extension 150 resides within the left atrium and engages tissue at or near the supra-annular region. The prosthesis 100 is further positioned such that the support arms 140 engage the outwardly facing surfaces of the native leaflets LF to capture the leaflets between the support arms 140 and the outer wall 123 of the valve support structure 120. As further described herein, the contact surface or landing zone 145 of each support arm 140 is configured to engage tissue at or near the sub-annular tissue so as to resist movement of the prosthesis 100 in an upstream direction during ventricular systole.

[0047] Figure 5B is shown in a radially expanded configuration (e.g., deployed state) and according to embodiments of the present technology Figure 5A An enlarged cross-sectional view of a heart valve prosthesis 100 is shown. Figure 5B , the prosthesis 100 is schematically shown as being located at the mitral valve MV on the right side of the illustration. When deployed and implanted, the heart valve prosthesis 100 is configured to position the artificial valve component 130 retained or held within the valve support structure 120 at a desired position and orientation within the native mitral valve MV. Figure 5A and 5B, several features of the prosthesis 100 provide resistance to movement of the prosthesis 100, promote tissue ingrowth, minimize or prevent paravalvular leakage, and / or minimize native tissue erosion when implanted in a radially expanded configuration. For example, the radially extending segments 150 can be positioned to expand within the atrial space above the mitral valve and engage cardiac tissue within the atrial space. In particular, at least the lower surface or top 153 of the arched or S-shaped struts 152 can provide a tissue engagement area for contacting supraannular tissue, for example to provide a seal against paravalvular leakage and inhibit downstream migration of the prosthesis 100 relative to the native valve annulus.

[0048] In some embodiments, the upwardly directed lip portions 158 of the struts 152 that rise to form the crown 156 can provide further tissue contact areas that can further inhibit downstream movement of the prosthesis 100 relative to the native annulus and inhibit rocking or side-to-side rotation of the prosthesis 100 within the native valve during the cardiac cycle, thereby inhibiting paravalvular leakage and ensuring alignment of the prosthetic valve assembly 130 within the native annulus. In other embodiments, the radially extending segment 150 can be a flange, rim, ring, finger-like projection, or other projection into the atrial space to at least partially engage tissue at or above its superior annular region.

[0049] Also refer to Figure 5A and 5B , showing a support arm 140 having a curved shape 141 and extending from a downstream portion 126 of the valve support structure 120. The support arm 140 is configured to engage the native leaflets (if present) and / or the sub-annular region of the mitral valve MV within the ventricular space. In one embodiment, the support arm 140 is configured to engage the outer surface of the leaflets (e.g., facing the ventricular side) such that the native leaflets are captured between the support arm 140 and the outer wall 123 of the valve support structure 120. In one such embodiment, the preformed curved shape 141 of the support arm 140 (e.g., at the transition top 144a of the second arcuate region 144) can be biased toward the outer wall 123 of the valve support structure 120 such that the compressive force F C1 The leaflets LF are pressed against the outer wall 123 of the valve support structure 120 in a manner that clamps, grasps, crimps, or otherwise confines the leaflets within the space 105 between the support arms 140 and the outer wall 123 of the valve support structure 120 .

[0050] To further inhibit upstream migration of the prosthesis 100 relative to the native valve annulus AN, the second arcuate region 144 is configured to engage the subannular region (e.g., behind the leaflets LF) via a contact surface or landing zone 145. In other embodiments, the second arcuate region 144 can contact tissue below the annulus AN, such as the ventricular wall (e.g., Figure 5CBy extending through, for example, the widened portion 446 to the arm tip 148 ( Figure 4A and 4C ) through the contact sub-ring region ( Figure 5A and 5B ) and / or tissue beneath the annulus AN ( Figure 5C ), the landing zone 145 distributes the surface contact over a larger area to inhibit tissue erosion and distribute the load stress on the support arm 140 in a non-traumatic manner.

[0051] In various arrangements, the curved shape 141 of the support arm 140 can form a generally S-shaped profile. In some arrangements, the support arm 140 can be more flexible (e.g., than other portions of the frame 110) and / or made of an elastic material (e.g., a shape memory material, a superelastic material, etc.) that can absorb forces applied to the support arm 140 when implanted in the heart 10 and during the cardiac cycle. For example, these forces can cause the generally S-shaped profile to temporarily deform, deflect, or otherwise change shape. Similarly, the curved shape 141 of the support arm can provide a compressive force F in an upstream direction (e.g., at the contact region 145) and against the annular tissue. C2 In one embodiment, the top 153 (e.g., lower surface) of the radially extending segment 150 can be longitudinally separated from the landing zone 145 of the second arcuate region by the gap 106. When implanted, the gap 106 can be sized to receive annular tissue therein. In one embodiment, the top 153 of the arcuate strut 152 can be longitudinally separated from the landing zone 145 of the second arcuate region by the gap 106. When implanted, the gap 106 can be sized to receive annular tissue therein. C2 Provides downward compressive force F on the opposing contact tissue C3 Therefore, the compressive force F C2 and F C3 The struts 152 may be aligned and / or opposite to each other so that the annular tissue is captured between the radially extending section 150 and the support arm 140 having the preformed curved shape 141. In some embodiments, the struts 152 may be circumferentially and radially aligned with the second arcuate region 144 of the support arm 140 so that the compressive force F C1 With compression force F C3 (like Figure 5B as shown) are directly opposite to each other to effectively clamp the annulus AN therebetween.

[0052] In some embodiments, portions of the prosthesis 100, such as the radially extending segments 150, the valve support structure 120, and / or the support arms 140, may be provided with a sealing material 160 ( Figure 4B) to cover at least a portion of the prosthesis 100. The sealing material 160 can prevent paravalvular leakage and provide a medium for tissue ingrowth after implantation, which can further provide biomechanical retention of the prosthesis 100 in a desired deployed position within the region of the native heart valve. In some embodiments, the sealing material 160 or a portion thereof can be a low porosity woven fabric, such as polyester, Polyester, or polytetrafluoroethylene (PTFE), creates a one-way fluid channel when attached to the frame 110. In one embodiment, the sealing material 160 or a portion thereof can be a looser knitted or woven fabric, such as a polyester or PTFE braid, which can be used when it is necessary to provide a medium for tissue ingrowth, as well as providing the ability of the fabric to stretch to conform to a curved surface. In another embodiment, a polyester velvet fabric can be substituted for at least a portion of the sealing material 160, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. For example, these and other suitable cardiovascular fabrics can be commercially available from Bard Peripheral Vascular, Inc. of Tempe, Arizona. In another embodiment, the sealing material 160 or a portion thereof can be a natural transplant material, such as the pericardium or another membrane tissue.

[0053] Figures 6A-6C is a side view of various support arm configurations according to additional embodiments of the present technology. Figures 6A-6C In one embodiment, support arm 140 can generally have a curved shape 141 with first and second curved regions 142, 144 separated by an elongated or generally straight region 143 that together extend generally parallel to longitudinal axis 601 (e.g., approximately aligned with longitudinal axis L of valve support structure 120). a Alignment; Figure 5B In some embodiments, the support arm 140 has an S-shaped profile. Figures 6A-6C As shown, the first arc-shaped area 142 may have a first curvature radius R1, and the second arc-shaped area 144 may have a second curvature radius R2. In some embodiments, the second curvature radius R2(a) is substantially equal to the first curvature radius R1( Fig. 6A ), (b) is much smaller than the first curvature radius R1 ( Figure 6B ), or (c) much larger than the first radius of curvature R1 ( Figure 6C ).

[0054] Also refer to Figure 5B and Figures 6A-6C, the second arcuate region 144 may have a tissue engaging portion or contact area 145 for engaging the sub-annulus or other cardiac tissue during and / or after deployment. Figures 6A-6C In the illustrated embodiment, the support arm 140 includes an arm post 146 located at a first end 140a, and a first arcuate region 142 extending generally from the longitudinal axis L A , 601 extends outwardly and radially aligns with the downstream portion of the valve support structure 120 ( Figure 5B The first arc-shaped area 142 surrounds the first curvature center C C1 Bend. Fig. 6A As shown, the generally straight or elongated portion 143 extends between the first arcuate region 142 and the second arcuate region 144. The second arcuate region 144 is radially aligned with the middle or central portion 170 of the valve support structure 120 between the upstream and downstream portions 124, 126 ( Figure 5B In one embodiment, the second arc-shaped area 144 is centered around the second curvature center C C2 Bend. Figure 5B and Figures 6A-6C In the embodiment shown, the first curvature center C C1 A first axis (not shown) is drawn parallel to the second center of curvature C C2 The first axis and the second axis are substantially perpendicular to the longitudinal axis L. A , 601( Fig. 6A ).

[0055] Reference Fig. 6A In some embodiments, arm 146 can be substantially linear and have a suitable length L1 for extending first arcuate region 142 downstream from a connector (not shown) to a desired distance of valve support structure 120. In some embodiments, arm 146 can be substantially parallel to prosthesis 100 and / or valve support structure 120 (e.g., Figure 5B The longitudinal axis L A .exist Fig. 6A Following the general curvature of the first curved region 142 shown, a first curved segment 610 of the region 142 extends radially outward from the arm 146. More specifically, the first curved segment 610 can be described as being curved or generally curved in an outward and downstream direction until it reaches the transition tip 142a of the first curved region 142. Thereafter, a second curved segment 614 of the first curved region 142 continues the curved profile and extends outward and generally in an upstream direction from the transition tip 142a.

[0056] like Fig. 6A As shown, the first transition point 616 starts at the elongated region 143 of the support arm 140, wherein the elongated region 143 is aligned with the longitudinal axis L of the valve support structure 120.A The second curved region 144 slopes and extends in an upward and inward direction to end at a second transition point 618. In a similar manner, the general curvature of the second curved region 144 begins at the second transition point 618, so that after the curvature of the second curved region 144, a third curved segment 620 is defined, which curves generally in an outward and upstream direction to reach the transition tip 144a of the second curved region 144. The fourth curved segment 622 of the second curved region 144 continues the curved profile and extends from the transition tip 144a in an outward direction (e.g., relative to the longitudinal axis L). A ) and may also bend slightly downstream toward the free end or arm tip 148. An opening 624 between the second arcuate region 144 and the first arcuate region 142 of the support arm 140 is typically formed in the space between the third transition portion 618 and the first end 140a of the support arm 140 and may be configured to receive the natural leaflet LF and / or the chordae tendineae therein. The support arm 140 of other embodiments may have curved sections 610, 614, 620 and 622 with less curvature or greater curvature. In addition, Figure 5B and Figures 6A-6C The support arms 140 of the illustrated embodiment may have a smaller size than the valve support structure 120 ( Figure 5B and Fig. 6A ) of the total height H1 of the height H2 of the first arcuate region 142. Other arrangements and heights are also conceivable. Therefore, in addition to the radii of curvature R1, R2 and / or other geometric features / changes of the first arcuate region 142 and the second arcuate region 144, the total height H1 of the support arm 140 can be selected to adapt to the anatomy at the desired target position of the heart valve.

[0057] Reference Fig. 6A, the first arcuate region 142 and the second arcuate region 144 of the support arm 140 can be configured to absorb, transform and / or mitigate twisting forces present within the heart during, for example, cardiac systole and cardiac diastole. In a particular arrangement, the support arm 140 has a spring-type response to twisting forces (e.g., a physical force that can be applied to the support arm 140 and change the profile of the support arm 140). As described in more detail herein, the support arm 140 may have multiple hinge points for bending or absorbing such twisting forces. For example, as a result of the spring-like response of a single support arm 140, a first twisting force can be absorbed in a manner that elastically or reversibly and temporarily twists the unbiased configuration of the support arm 140. As the first twisting force dissipates (e.g., during the cardiac cycle), the spring-like motion continues the transition of the support arm profile from the twisted position back to the unbiased configuration. Therefore, the spring-like response of the support arm 140 occurs in a manner opposite to the first twisting force. In these arrangements, the degree to which the support arm 140 is compressed and / or extended is proportional to the twisting force applied to the support arm. The support arm 140 can have a selected stiffness that provides a constant for the distance or increment of twist (e.g., compression, expansion). In certain arrangements, the support arm 140 can have a constant stiffness along the entire length of the support arm and covering all multiple hinge points. In other arrangements, the support arm 140 can have a variable stiffness along the length of the support arm and including different hinge points. This stiffness selectivity of a single support arm 140 can provide a prosthesis design to accommodate unique and variable natural structures, such as for accommodating variable twisting forces applied by the natural mitral valve region. Variable stiffness can be achieved in a variety of ways: i) differences in cross-sectional area of ​​the support arms, ii) variable cold working of selected support arms in the case of traditional elastoplastic metals (e.g., stainless steel, titanium alloys, cobalt-chromium alloys), and / or iii) selective heating or heat treatment of one or more support arms but not other support arms.

[0058] In certain embodiments, the shapes and / or sizes of the first arcuate region 142 and the second arcuate region 144 can be selected to accommodate forces, such as radial compressive forces Fa, longitudinal diastolic forces Fd and contractile forces Fs, hoop stress, etc., exerted by the native valve annulus and / or valve leaflets. The absorption of twisting forces can be used to prevent those forces from being transferred to the valve support structure 120 and thereby maintain the engagement of the artificial valve assembly 130. In addition, as Figure 7As further shown, the absorption of torsional forces along the entire support arm 140 and / or at several hinge points or locations 701 (e.g., transitions 140a, 142a, 616, 618, and 144a) distributes the stress caused by the force, thereby substantially preventing fatigue of the support arm 140 and / or minimizing tissue erosion at the contacting portion of the native anatomy. In accordance with the present technology, the support arm 140 can bend, bend, rotate, or twist under the action of torsional forces while the valve support structure 120 generally maintains its rigidity and / or original shape (e.g., generally circular).

[0059] Figures 8A-8H 1 is a side view of various support arms 140 that bend in response to twisting forces according to other embodiments of the present technology. The degree of flexibility of an individual support arm 140 can be consistent between all support arms 140 of the prosthesis 100, or alternatively, some support arms 140 can be more flexible than other support arms 140 on the same prosthesis 100. Similarly, the degree of flexibility of an individual support arm 140 can be consistent throughout the entire length of the support arm 140 or be consistent in the curvature of the first arcuate region 142 and the second arcuate region 144. However, in other embodiments, the degree of flexibility can vary along the length and / or shape of each support arm 140.

[0060] like Figures 8A-8H As shown, the first and second arcuate regions 142, 144 of the support arm 140 can be bent relative to the arm post 146, the valve support structure 120 (shown in phantom) and / or configured to change their arcuate shapes in response to changing distortion forces F that may be applied by surrounding tissue during or after implantation of the prosthesis 100. Fig. 8A ), the first arcuate region 142 may bend downwardly to the shape / position 842b ( ) in response to a downward force F1 caused by, for example, a chordal load (e.g., from a tendon engaging the first arcuate region 142). Figure 8B In another embodiment, the second arcuate region 144 may bend downward and the first arcuate region 142 may be curved from a static position ( Fig. 8A ) compressed to shape / position 844c and 842c ( Figure 8C ), respectively, in response to a downward force F2 caused by, for example, a tip load (e.g., from left ventricular pressure). Similarly, the first arcuate region 142 and the second arcuate region 144 respond to an inward force F in a lateral direction caused by, for example, a ventricular wall load (e.g., left ventricular contraction). 3a 、F 3b Can be bent or compressed inwardly to shape / position 842d, 844d ( Fig.8DThe engagement of the second arcuate region 144 generating force F4 with the native valve ring may cause the second arcuate region 144 to bend inward and compress to shape / position 844e, which may also promote the position change in the first arcuate region to position 842e ( Fig. 8E In some embodiments, the first arc region 142 and the second arc region 144 respond to the lateral force F 3a 、F 3b , F4 or bend downward, rotate inward / outward and / or deform in response to generally vertical forces F1, F2.

[0061] In other arrangements, such as Figure 8F-8H As shown, in Figure 8F The first arcuate region 142 and the second arcuate region 144 shown in the static position may also be formed by one or more transition portions 140a, 142a, 616, 618 and 144a ( Fig. 6A ) and bends and / or rotates laterally to, for example, position 842g / 844g ( Figure 8G ) or 842h / 844h( Figure 8H ), for example at independent and variable angles away from the midline 802 so that the arm tips 148 can be spread apart from each other.

[0062] Fig. 9 FIG. 1 is a diagram of a device in a compressed delivery configuration (e.g., a low profile or radially compressed state) configured in accordance with an embodiment of the present technology. Figure 5A-5B FIG. 1 is an enlarged cross-sectional view of a heart valve prosthesis 100. The prosthesis 100 may be configured for use in Fig. 9 More specifically, in the radially compressed configuration, the radially extending section 150 can be elongated, folded, or otherwise arranged to extend longitudinally from the valve support structure 120 in a generally straight state. In addition, the plurality of support arms 140 extend longitudinally and are arranged in a generally straight state for percutaneous delivery to a target native heart valve. Fig. 9 As shown, the support arm 140 can extend beyond the second end 127 of the valve support structure 120 so that the first arcuate region 142 is substantially straight and parallel to the longitudinal axis L. A The radially extending segments 150 are substantially parallel, while the second arcuate region 144 maintains a curved profile. Once the radial constraint is released, the delivery catheter sheath (not shown) is withdrawn and the radially extending segments 150 can self-expand to a radially expanded configuration ( Figure 5B ), the support arms 140 can be moved to an outwardly biased position. In addition, in the event that the heart valve prosthesis 100 needs to be repositioned, removed, and / or replaced after implantation, the radially extending segments 150 and the valve support structure 120 can be moved from a radially expanded configuration (e.g., a deployed state) ( Figure 5B) Use a catheter device or other lateral retention sheath to transition back to the radially contracted configuration ( Fig. 9 ).

[0063] Access to the mitral valve or other atrioventricular valves may be accomplished percutaneously through the patient's vasculature. Depending on the point of vascular access, access to the mitral valve may be antegrade and may rely on entering the left atrium through the atrial septum. Alternatively, access to the mitral valve may be retrograde through the aortic valve or through a transapical puncture into the left ventricle. Once percutaneous access is achieved, interventional tools and support catheters may be advanced intravascularly to the heart and positioned proximal to the target heart valve in a variety of ways. For example, the heart valve prosthesis 100 may be delivered to the region of the native mitral valve for insertion through a transseptal approach (e.g., Fig.10 The invention relates to a method for repairing or replacing a native valve by retrograde approach through the aortic valve or via transapical puncture. Suitable transapical and / or transarterial implantation procedures for the heart valve prosthesis 100 described herein are disclosed in U.S. Application No. 13 / 572,842 filed on August 13, 2012 to Igor Kovalsky, U.S. Application Publication No. 2011 / 0208297 to Tuval et al., and U.S. Application Publication No. 2012 / 0035722 to Tuval et al., which are hereby incorporated by reference in their entirety.

[0064] Fig.10 is a cross-sectional view of a heart 10 according to another embodiment of the present technology, illustrating the steps of a method for implanting a heart valve prosthesis 100 using a transseptal approach. Figure 5A , Fig. 9 and Fig.10 , the prosthesis 100 can be advanced to the vicinity of the mitral valve MV within the delivery catheter 20. Optionally, a guide wire (not shown) can be used, and the delivery catheter 20 can be slidably advanced over the guide wire. Fig.10 As shown, the sheath 22 of the delivery catheter 20 (which includes a radially compressed configuration ( Fig. 9 The prosthesis 100 shown in FIG. 1 is advanced through the mitral annulus AN between the native leaflets LF. Fig.10 The sheath 22 is then retracted proximally, allowing the prosthesis 100 to expand so that the support arms 140 are in an outward position aligned with the longitudinal axis L. A The first arcuate region 142 is spatially separated, and at the same time the valve support structure 120 remains radially contracted. In this expansion phase, the shape-memory bias of the first arcuate region 142 can promote the outward movement of the support arm 140. In this transition phase, the first arcuate region 142 may have a third radius of curvature R3 greater than the first radius of curvature R1, while the second arcuate region 144 continues to retain the second radius of curvature R2. In the mitral valve MV (such as Fig.10During all stages of deployment within the second arcuate region 144, the second arcuate region 144 provides atraumatic engagement of cardiac tissue (as shown in FIG. Fig.10 ). For example, when transitioning between the radially contracted configuration and the radially expanded configuration, the second arcuate region 144 is configured to deflect in response to contact with the chordae tendineae CT. The second arcuate region 144 may also atraumatically engage the wall of the left ventricle LV as the support arm 140 moves or swings behind the native leaflet LF during deployment. When the support arm 140 is fully deployed (e.g., Figure 5A ), the support arm 140 is relative to the longitudinal axis L A Further inward positioning and engagement of the leaflets LF between the support arms 140 and the valve support structure 120. The sheath 22 can be further retracted to release the valve support structure 120 and the radially extending segments 150 (eg, within the space of the left atrium LA).

[0065] After the sheath 22 has been removed and the prosthesis 100 is allowed to return to its expanded state, the delivery catheter 20 may still be connected to the prosthesis 100 (e.g., a system eyelet not shown connected to a prosthesis eyelet) so that the operator can further control the placement of the prosthesis 100 as the prosthesis 100 expands toward the radially expanded configuration. For example, the prosthesis 100 may be expanded upstream or downstream of the target location before being released from the delivery catheter 20 and then pushed downstream or upstream, respectively, to the desired target location. Once the prosthesis 100 is positioned at the target location, the delivery catheter 20 may be retracted in the proximal direction and disengaged from the prosthesis 100 when the prosthesis 100 is in the radially expanded configuration at the target native valve (e.g., the mitral valve MV).

[0066] Although various embodiments have been described above, it should be understood that they are presented only as illustrations and examples of the present technology, and not as limitations. It will be apparent to those skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present technology. Therefore, the breadth and scope of the present technology should not be limited by any of the above-described embodiments, but should only be defined in accordance with the appended claims and their equivalents. It should also be understood that each feature of each embodiment discussed herein and each feature of each reference cited herein may be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated herein by reference in their entirety.

Claims

1. A heart valve prosthesis for implantation in the natural valve region of the heart, the heart valve prosthesis include: a valve support structure having an upstream portion and a downstream portion and configured to retain a prosthetic valve component therein; a radially extending segment coupled to the upstream portion of the valve support structure, wherein the radially extending segment is configured to engage a super-annular surface of the native valve region when the heart valve prosthesis is in an expanded configuration; as well as a plurality of support arms extending from the downstream portion of the valve support structure, each support arm being configured to extend from the downstream portion toward the upstream portion when the heart valve prosthesis is in an expanded configuration, Wherein, in the expanded configuration, each of the plurality of support arms has a curved shape, the curved shape is configured to absorb the twisting force applied thereto by the natural valve region, each of the plurality of support arms also has an atraumatic landing area, the atraumatic landing area is configured to be opposite to the radial extension section, and a compressive force is applied to the valve ring at the natural valve region through the atraumatic landing area and the radial extension section, thereby inhibiting the movement of the heart valve prosthesis, Wherein, the curve shape is generally S-shaped, wherein the S-shape of each of the support arms is defined by a first arc-shaped region, a second arc-shaped region, and an elongated region extending between the first arc-shaped region and the second arc-shaped region, Wherein, the second arc-shaped region of the S-shaped support arm defines the atraumatic landing zone, and the atraumatic landing zone is configured to atraumatically engage with tissue at the natural surface area.

2. The heart valve prosthesis according to claim 1, It is characterized in that The first arcuate region has a first radius of curvature, and the second arcuate region has a second radius of curvature, the second radius of curvature being substantially equal to the first radius of curvature.

3. The heart valve prosthesis according to claim 1, It is characterized in that The first arcuate region has a first radius of curvature, and the second arcuate region has a second radius of curvature, the second radius of curvature being greater than or less than the first radius of curvature.

4. The heart valve prosthesis according to claim 1, It is characterized in that The native valve region is the mitral valve, and the valve ring is the mitral valve ring, wherein the non-traumatic landing areas of the multiple support arms are longitudinally spaced apart from the radial extension section so that the mitral valve ring can be located therebetween.

5. The heart valve prosthesis according to claim 1, It is characterized in that The native valve region is the mitral valve, the valve annulus is the mitral valve annulus, wherein one or more of the plurality of curved support arms are configured to engage with the subannular surface of the mitral valve annulus and the left ventricular wall.

6. The heart valve prosthesis according to claim 1, It is characterized in that The width of the atraumatic landing zone is greater than the width of the remainder of the curved support arm.

7. The heart valve prosthesis according to claim 1, It is characterized in that The atraumatic landing zone includes one or more tissue clamping features.

8. A heart valve prosthesis for implantation in the natural valve region of the heart, the heart valve prosthesis include: a cylindrical support structure having an upstream portion and a downstream portion and configured to retain a prosthetic valve component therein; a plurality of S-shaped support arms extending from the cylindrical support structure, the plurality of S-shaped support arms having landing zones formed thereon, each of the landing zones having a width greater than a width of a remainder of the S-shaped support arm, wherein when the heart valve prosthesis is in an expanded configuration, the S-shaped support arms are configured to extend in an upstream direction such that the landing zones engage heart tissue above or below the native valve region, Each of the S-shaped support arms is defined by a first arc-shaped region, a second arc-shaped region, and an elongated region extending between the first arc-shaped region and the second arc-shaped region. Wherein, the second arc-shaped region of the S-shaped support arm defines the landing area, and the landing area is configured to engage with the heart tissue above or below the natural valve area in a non-traumatic manner.

9. The heart valve prosthesis according to claim 8, It is characterized in that The first arcuate region has a first radius of curvature, and the second arcuate region has a second radius of curvature, the second radius of curvature being substantially equal to the first radius of curvature.

10. The heart valve prosthesis according to claim 8, It is characterized in that The first arcuate region has a first radius of curvature, and the second arcuate region has a second radius of curvature, the second radius of curvature being greater than or less than the first radius of curvature.

11. The heart valve prosthesis according to claim 8, It is characterized in that Also included is a radially extending segment extending from the upstream portion of the cylindrical support structure, the radially extending segment being configured to engage cardiac tissue above or below the native valve region.

12. The heart valve prosthesis according to claim 11, It is characterized in that When the prosthesis is in an expanded configuration, the cylindrical support structure has a first cross-sectional dimension and the radially extending segment has a second cross-sectional dimension that is greater than the first cross-sectional dimension.

13. The heart valve prosthesis according to claim 12, It is characterized in that When the heart valve prosthesis is in the expanded configuration and deployed at the native mitral valve, the annulus of the mitral valve is positioned between the landing area and the radially extending section of the plurality of S-shaped support arms.

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