Patent Description:
The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atria and right ventricle which supplies the pulmonary circulation, and the left atria and left ventricle which supplies oxygenated blood received from the lungs to the remaining body. To insure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atria and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber to occur at the proper flow rate and cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening,.

Prosthetic heart valves have been developed for repair and replacement of diseased and/or damaged heart valves. Such valves can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Such prosthetic heart valves can be delivered while in a low-profile or compressed/contracted arrangement so that the prosthetic valves can be contained within a sheath component of a delivery catheter and advanced through the patient's vasculature. Once positioned at the treatment site, the prosthetic valves can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the prosthetic valve in position. While these prosthetic valves offer minimally invasive methods for heart valve repair and/or replacement, challenges remain to provide prosthetic valves that prevent leakage between the implanted prosthetic valve and the surrounding tissue (paravalvular leakage) and for preventing movement and/or migration of the prosthetic valve that could occur during the cardiac cycle. For example, the mitral valve presents numerous challenges, such as prosthetic valve dislodgement or improper placement due to the presence of chordae tendinae and remnant leaflets, leading to valve impingement. Additional challenges can include providing a prosthetic valve that resists pre-mature failure of various components that can occur when subjected to the distorting forces imparted by the native anatomy and during the cardiac cycle. Further anatomical challenges associated with treatment of a mitral valve include providing a prosthetic valve to accommodate the oval or kidney shape. Moreover, the kidney-shaped mitral valve annulus has muscle only along the exterior wall of the valve with only a thin vessel wall that separates the mitral valve and the aortic valve. This anatomical muscle distribution, along with the high pressures experienced on the left ventricular contraction, can be problematic for mitral valve prosthesis.

(<CIT> relates to a prosthetic valve for replacing a mitral valve.

An embodiment of the prosthetic valve includes a radially compressible main body and a one-way valve portion, The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve may include an atrial sealing member adapted for placement above the annulus of the mitral valve.

The claimed invention is defined in independent claim <NUM>. Aspects, embodiments and examples of the present disclosure which are not encompassed by the appended claims are not part of the claimed invention and are provided for illustrative purposes.

Embodiments hereof are directed to heart valve prostheses The heart valve prostheses have a compressed configuration for delivery via a vasculature or other body lumens to a native heart valve of a patient and an expanded configuration for deployment within the native heart valve. In an embodiment, the heart valve prosthesis may include a frame having a valve support that is configured to hold a prosthetic valve component therein, and a plurality of support arms extending from the valve support such that when the heart valve prosthesis is in the expanded configuration the plurality of support arms are configured to extend toward the first end of the valve support for engaging a subannular surface of the native heart valve. One or more of the plurality of support arms comprises a curvilinear-shaped support arm, the curvilinear-shaped support arm being formed to have opposing first and second arcuate regions longitudinally separated by a straight region extending therebetween, with the first arcuate region being formed to curve toward the valve support proximate a downstream portion thereof, the straight region being formed to slant toward the valve support while joining the first arcuate region and the second arcuate region, and the second arcuate region being formed to curve away from the valve support proximate an upstream portion thereof.

In another embodiment, a heart valve prosthesis for implantation at a native valve region of a heart includes a valve support having an upstream portion and a downstream portion, the valve support being configured to retain a prosthetic valve component therein and having a plurality of support arms extending from the downstream portion of the valve support. 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 to have a curvilinear shape with a first curved region having a first radius of curvature, a second curved region having a second radius of curvature and an elongate region extending between the first curved region and the second curved region. In such supports arms, the curvilinear shape is configured to absorb distorting forces exerted thereon by the native valve region.

In another embodiment, a heart valve prosthesis for treating a native mitral valve of a patient is disclosed. The heart valve prosthesis includes a cylindrical support having an upstream portion, a downstream portion and a first cross-sectional dimension, wherein the cylindrical support is configured to hold a prosthetic valve component that inhibits retrograde blood flow. A plurality of S-shaped support arms extend from the downstream portion of the cylindrical support, 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 cardiac tissue on or below an annulus of the native mitral valve. A radially-extending segment extends from the upstream portion of the cylindrical support and is of a second cross-sectional dimension greater than the first cross-sectional dimension. The radially-extending segment is configured to engage cardiac tissue on or above the annulus of the native mitral valve such that when the heart valve prosthesis is in the expanded configuration and deployed at the native mitral valve, the annulus is positioned between upstream curved segments of the S-shaped support arms and the radially-extending segment.

The foregoing and other features and aspects of the present technology can be better understood from the following description of embodiments and as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to illustrate the principles of the present technology. The components in the drawings are not necessarily to scale.

Specific embodiments of the present technology are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to the treating clinician or with respect to a prosthetic heart valve device. For example, "distal" or "distally" are a position distant from or in a direction away from the clinician when referring to delivery procedures or along a vasculature. Likewise, "proximal" and "proximally" are a position near or in a direction toward the clinician. With respect to a prosthetic heart valve device, the terms "proximal" and "distal" can refer to the location of portions of the device with respect to the direction of blood flow. For example, proximal can refer to an upstream position or a position of blood inflow, and distal can refer to a downstream position or a position of blood outflow.

The following detailed description is merely exemplary in nature and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof are in the context of treatment of heart valves and paiticularly a mitral valve, the present technology may also be used in any other body passageways where it is deemed useful.

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

<FIG> is a schematic sectional illustration of a mammalian heart <NUM> that depicts the four heart chambers (right atria RA, right ventricle RV, left atria LA, left ventricle LV) and native valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV). <FIG> is a schematic sectional illustration of a left ventricle LV of a mammalian heart <NUM> showing anatomical structures and a native mitral valve MV. Referring to <FIG> and <FIG> together, the heart <NUM> comprises the left atrium LA that receives oxygenated blood from the lungs via the pulmonary veins. The left atrium LA pumps the oxygenated blood through the mitral valve MV and into the left ventricle LV during ventricular diastole. The left ventricle LV contracts during systole and blood flows outwardly through the aortic valve AV, into the aorta and to the remainder of the body.

In a healthy heart, the leaflets LF of the mitral valve MV meet evenly at the free edges or "coapt" to close and prevent back flow of blood during contraction of the left ventricle LV (<FIG>). Referring to <FIG>, the leaflets LF attach the surrounding heart structure via a fibrous ring of connective tissue called an annulus AN. The flexible leaflet tissue of the mitral leaflets LF are connected to papillary muscles PM, which extend upwardly from the lower wall of the left ventricle LV and the interventricular septum IVS, via branching tendons called chordae tendinae CT. In a heart <NUM> having a prolapsed mitral valve MV in which the leaflets LF do not sufficiently coapt or meet, as shown in <FIG>, leakage from the left ventricle LV into the left atrium LA will occur. Several structural detects can cause the mitral leaflets LF to prolapse and regurgitation to occur, including ruptured chordae tendinae CT, impairment of papillary muscles PM (e.g., due to ischemic heart disease), and enlargement of the heart and/or mitral valve annulus AN (e.g., cardiomyopathy).

<FIG> is a superior view of a mitral valve MV isolated from the surrounding heart structures and further illustrating the shape and relative sizes of the leaflets LF and 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 meets a posterior leaflet PL at a coaptation line when closed. When the anterior leaflet AL and posterior leaflet PL fail to meet, regurgitation between the leaflets AL, PL or at commissures C at the corners between the leaflets can occur.

Embodiments of prosthetic heart valve devices and associated methods in accordance with the present technology are described in this section with reference to <FIG>. It will be appreciated that specific elements, substructures, uses, advantages, and/or other aspects of the embodiments described herein and with reference to <FIG> can be suitably interchanged, substituted or otherwise configured with one another in accordance with additional embodiments of the present technology.

Provided herein are systems, devices and methods suitable for percutaneous delivery and implantation of prosthetic heart valves in a heart of a patient. In some embodiments, methods and devices are presented for the treatment of valve disease by minimally invasive implantation of artificial or prosthetic heart valves. For example, a prosthetic heart valve device, in accordance with embodiments described herein, can be implanted for replacement of a diseased or damaged native mitral valve or prior implanted prosthetic mitral valve in a patient, such as in a patient suffering from a prolapsed mitral valve illustrated in <FIG>. In further embodiments, the device is suitable for implantation and replacement of other diseased or damaged heart valves or prior implanted prosthetic heart valves, such as tricuspid, pulmonary and aortic heart valves.

<FIG> is a side view of a heart valve prosthesis or a prosthetic heart valve device <NUM> in a radially expanded or deployed configuration (e.g., a deployed state) in accordance with an embodiment of the present technology. <FIG> is a top view of the heart valve prosthesis <NUM> as configured in <FIG>, and <FIG> is a top view of the prosthesis <NUM> taken along lines C-C of <FIG>. Referring to <FIG> together, the heart valve prosthesis <NUM> includes a frame or stent-like support structure <NUM> that includes a tubular portion or structural valve support <NUM> that defines a lumen <NUM> for retaining, holding and/or securing a prosthetic valve component <NUM> therein. The valve support <NUM> can be generally cylindrical in shape having an upstream portion <NUM> at a first end <NUM> and a downstream portion <NUM> at a second end <NUM> that are oriented along a longitudinal axis LA of the valve support <NUM> (<FIG>). The frame <NUM> further includes one or more support arms <NUM> extending radially outward from the valve support <NUM> and generally in an upstream direction from the downstream portion <NUM> of the valve support <NUM> (e.g., to reach behind native leaflets of the mitral valve and engage cardiac tissue in the subannular region within the left ventricle). At least some of the support arms <NUM> can have a curvilinear shape <NUM> configured to atraumatically engage the native annulus and substantially absorb distorting forces such that the prosthesis <NUM> is supported by the annulus when prosthetic valve component <NUM> is closed during systole.

As shown in the radially expanded configuration of <FIG>, the frame <NUM> further includes a radially-extending segment or radial extension portion <NUM> at least partially surrounding and extending from the upstream portion <NUM> of the valve support <NUM>. The radially-extending segment <NUM> can include a plurality of self-expanding struts <NUM> configured to radially expand when the prosthesis <NUM> is deployed to the expanded configuration. In some arrangements, the radially-extending segment <NUM> can engage tissue on or above the annulus when implanted within a native mitral valve space. In this embodiment, the radially-extending segment <NUM> can retain the valve support <NUM> in a desired position within the native valve region (e.g., between the native leaflets and annulus of the mitral valve). Referring to <FIG>, the radially-extending segment <NUM> and/or the valve support <NUM> can include a sealing material <NUM> that can extend around an upper or upstream surface <NUM> or a lower or downstream surface <NUM> (<FIG>) of the radially-extending segment <NUM>, and/or around an interior wall <NUM> or an exterior wall <NUM> of the valve support <NUM> to prevent leakage of blood (e.g., paravalvular leakage) between the implanted prosthesis <NUM> and the native heart tissue.

Referring to <FIG>, the radially-extending segment <NUM> and valve support <NUM> are shown having generally circular cross-sectional shapes with the radially-extending segment <NUM> having a cross-sectional dimension D<NUM> that is greater than a cross-sectional dimension D<NUM> of the valve support <NUM>. In some embodiments, the radially-extending segment <NUM>, the valve support <NUM> or both can have other cross-sectional shapes, such as to accommodate the D-shaped or kidney-shaped mitral valve. For example, the radially-extending segment <NUM> and/or valve support <NUM> may expand to an irregular, non-cylindrical, or oval-shaped configuration for accommodating the mitral valve or other valves. Furthermore, the native valves (e.g., mitral, aortic) can be uniquely sized and/or have other unique anatomical shapes and features that vary between patients, and the prosthesis <NUM> for replacing or repairing such valves can be suitable for adapting to the size, geometry and other anatomical features of such native valves. For example, the radially-extending segment <NUM> can expand within the native heart valve region while simultaneously being flexible so as to conform to the region engaged by the radially-extending segment <NUM>.

<FIG> and <FIG> show the radially-extending segment <NUM> having the plurality of struts <NUM> that outwardly extend from the exterior wall <NUM> at the first end <NUM> of the valve support <NUM>. In one embodiment, the struts <NUM> are arranged relatively evenly about a circumference of the valve support <NUM>, and individual struts <NUM> join an adjacent strut <NUM> at a crown <NUM>. In one embodiment the crowns <NUM> have an atraumatic tip <NUM> that prevents injury to the cardiac tissue during deployment and through the cardiac cycle. Examples of suitable radially-extending segments <NUM> are described in <CIT>.

Referring back to <FIG> and <FIG>, a plurality of support arms <NUM> extend from the downstream portion <NUM> of the valve support <NUM>, and are generally evenly spaced about the circumference of the exterior wall <NUM> of the valve support <NUM> (<FIG>). In alternative arrangements, not shown, the support arms <NUM> can be unevenly spaced, grouped, irregularly spaced, etc. about the circumference. In a particular example, the support arms <NUM> can be grouped closer together and extend from the valve support <NUM> at positions that generally align with the anterior and posterior leaflets of the mitral valve when deployed. The embodiment shown in <FIG> has twelve support arms <NUM> evenly spaced about the circumference of the valve support <NUM>. In alternative arrangements, the prosthesis <NUM> can include less than <NUM> support arms <NUM>, e.g., two support arms, two to six support arms, greater than six support arms, nine support arms, etc., or more than twelve support arms <NUM>.

Referring to <FIG>, the support arms <NUM> may extend from the valve support <NUM> at or near the second end <NUM> and may be described as extending generally toward the upstream portion <NUM> along or in parallel with the exterior wall <NUM> of the valve support <NUM>. As shown, the support arm <NUM> can have the generally curvilinear shape <NUM> or similar geometry. The curvilinear shape <NUM> includes opposing arcuate or curved regions <NUM>, <NUM> longitudinally separated by a slanted elongate or straight region <NUM> that extends therebetween. When positioned for use within a native mitral valve, arcuate region <NUM> of a curvilinear support arm <NUM> may be referred to as a downstream curved segment <NUM> and arcuate region <NUM> of the curvilinear support arm <NUM> may be referred to as an upstream curved segment <NUM>.

In some embodiments, the curvilinear shape <NUM> includes a first arcuate (e.g., curved) region <NUM> formed to curve in a direction toward the exterior wall <NUM> to engage a portion of at least one leaflet of the native heart valve or other structures in the heart valve region, such as chordae tendinae. In one embodiment, the first arcuate region <NUM> may extend around a downstream edge of the native valve leaflet. In a medial section of the support arm <NUM>, the support arm includes the straight region <NUM> configured to follow from the first arcuate region <NUM> and to slant in a direction toward the exterior wall <NUM> at an intermediate or middle portion <NUM> of the valve support <NUM>. In a free-end section of the support arm <NUM> proximate the first end <NUM> of the valve support <NUM>, and following the straight or elongate region <NUM> along the curvilinear shape <NUM>, the support arm <NUM> further includes a second arcuate (e.g., curved) region <NUM> formed to curve in a direction away from the exterior wall <NUM> of the valve support <NUM> and to engage tissue at or proximate to the native heart valve when implanted. In a particular example, the second arcuate region <NUM> can engage subannular tissue and/or portions of a heart chamber wall, e.g., a ventricular wall, in an atraumatic matter. In reference to <FIG>, and in a particular embodiment, the first arcuate region <NUM> is longitudinally separated from the second arcuate region <NUM> by the straight or elongate region <NUM> to form or define a substantially S-shaped profile.

In the embodiment shown in <FIG> and <FIG>, the second arcuate region <NUM> on each of the support arms <NUM> provides or defines a contact area or landing zone <NUM> that is configured to atraumatically engage tissue at or near the subannular tissue so as to inhibit tissue erosion and/or resist movement of the prosthesis <NUM> in an upstream direction during ventricular systole, as is described further herein. As illustrated, the second arcuate region <NUM> includes a widened and/or flattened portion <NUM> that forms the landing zone <NUM>. As shown in <FIG>, the widened portion <NUM> has a first width W<NUM> that is greater than a width W<NUM> at the first arcuate region <NUM> of the support arm <NUM>. When the prosthesis <NUM> is deployed and in contact with tissue (e.g., subannular tissue, native leaflets, ventricle wall, etc.) via the widened portion <NUM>, the landing zone <NUM> effectively distributes native tissue contact over a greater surface area to inhibit tissue erosion and to distribute load stress on the support arms <NUM>. In the embodiment shown in <FIG> and <FIG>, the landing zone <NUM> includes grooves <NUM> formed along the widened portion <NUM> that can provide additional barriers against movement of the landing zone <NUM> with respect to the contacted tissue. In alternative arrangements, the landing zone <NUM> can include raised portions, bumps, cut-outs and other features that provide additional movement resistance against the contacted tissue once deployed. In various arrangements, by resisting movement of the landing zone <NUM> against the contacted native tissue, the support arms <NUM> provide atraumatic contact in a manner that limits or inhibits tissue erosion and/or abrasion following implantation of the prosthesis <NUM>. In certain embodiments, and as shown in <FIG> and <FIG>, the support arm <NUM> includes an arm tip <NUM> that can be rounded or otherwise atraumatic to cardiac tissue engaged by the arm tip <NUM> either during deployment or when fully implanted. In the illustrated embodiment, the arm tip <NUM> includes a hole <NUM> for attaching the support arms <NUM> to a delivery catheter (not shown) in a radially-compressed configuration for delivery to a target site. Additionally, or alternatively, one or more of the holes <NUM> may be filled with a secondary material (e.g. Tantalum, Platinum, Gold) for improved visibility during fluoroscopy-guided delivery. In alternative arrangements, the support arms <NUM> may not include a hole <NUM> and/or other landing zone features (e.g., grooves <NUM>) without departing from the scope hereof.

In some embodiments described herein, and in order to transform or self-expand between an initial compressed configuration (e.g., in a delivery state, not shown) and the deployed configuration (<FIG>), the frame <NUM> is formed from a resilient 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 <NUM> can be a unitary structure that defines the radially-extending segment <NUM> at the inflow portion of the prosthesis <NUM>, the valve support <NUM> and the plurality of support arms <NUM>, and the frame <NUM> so described may be made from stainless steel, a pseudo-elastic metal such as nickel titanium alloy or nitinol, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. In some arrangements, the frame <NUM> can be formed as a unitary structure, for e.g., from a laser cut, fenestrated, nitinol or other metal tube. Mechanical memory may be imparted to the structure that forms the frame <NUM> by thermal treatment to achieve a spring temper in the stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. The frame <NUM> may also include polymers or combinations of metals, polymers or other materials.

In one embodiment, the frame <NUM> can be a flexible metal frame or support structure having a plurality of ribs and/or struts (e.g., struts <NUM>, <NUM>) geometrically arranged to provide a latticework capable of being radially compressed (e.g., in a delivery state, not shown) for delivery to a target native valve site, and capable of radially expanding (e.g., to the radially expanded configuration shown in <FIG>) for deployment and implantation at the target native valve site. Referring to the valve support <NUM> shown in <FIG>, the ribs and struts <NUM> can be arranged in a plurality of geometrical patterns that can expand or flex and contract while providing sufficient resilience and strength for maintaining the integrity of the prosthetic valve component <NUM> housed within. For example, the struts <NUM> can be arranged in a circumferential pattern about the longitudinal axis LA, wherein the circumferential pattern includes a series of diamond, zig-zagged, sinusoidal, or other geometric shapes.

In other embodiments, the frame <NUM> can include separately manufactured components that are coupled, linked, welded, or otherwise mechanically attached to one another to form the frame <NUM>. For example, the radially-extending segment <NUM> can be coupled to the upstream portion <NUM> of the valve support <NUM> (e.g., at attachments points 129a on the struts <NUM> as defined by a diamond-shaped geometry of the valve support <NUM>). Likewise, the support arms <NUM> can be coupled to the downstream portion <NUM> of the valve support <NUM> (e.g., at attachment points 129b on the struts <NUM> as defined by the diamond-shaped geometry of the valve support <NUM>). Other arrangements and attachment points are contemplated for coupling one or more of the support arms <NUM> and radially-extending segment <NUM> to the valve support <NUM>. In particular embodiments, and as shown in <FIG>, the support arms <NUM> can be coupled to the valve support <NUM> via an arm post <NUM>. In one embodiment, the arm post <NUM> can be integral with the frame <NUM> such that the arm post <NUM> is an extension of one or more struts <NUM>. In another embodiment, the arm posts <NUM> and valve support <NUM> may be coupled by a variety of methods known in the art, e.g., soldering, welding, bonding, rivets or other fasteners, mechanical interlocking, or any combination thereof. In one embodiment, the valve support <NUM> can be a balloon-expandable tubular metal stent, and the radially-extending segment <NUM> and the support arms <NUM> of the frame <NUM> may be formed from material and by methods so as to be self-expanding as described above. In another embodiment in accordance herewith, support arms <NUM> may extend from or be coupled to an intermediate or middle portion <NUM> of the valve support <NUM> without departing from the scope hereof.

Referring to <FIG>, the prosthetic valve component <NUM> may be coupled to the interior wall <NUM> of the valve support <NUM> for governing blood flow through the heart valve prosthesis <NUM>. For example, the prosthetic valve component <NUM> can include a plurality of leaflets <NUM> (shown individually as 132a-b) that coapt and are configured to allow blood flow through the prosthesis <NUM> in a downstream direction (e.g., from the first end <NUM> to the second end <NUM>) and inhibit blood flow in an upstream direction (e.g., from the second end <NUM> to the first end <NUM>). While the prosthetic valve component <NUM> is shown having a bicuspid arrangement, it is understood that the prosthetic valve component <NUM> can have three leaflets <NUM> (tricuspid arrangement, not shown) or more than three leaflets <NUM> that coapt to close the prosthetic valve component <NUM>. In one embodiment, the leaflets <NUM> can be formed of bovine pericardium or other natural material (e.g., obtained from heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals) that are mounted to the interior wall <NUM> of the valve support <NUM>. In another embodiment, synthetic materials suitable for use as valve leaflets <NUM> include DACRON® polyester (commercially available from Invista North America S. of Wilmington, DE), other cloth materials, nylon blends, polymeric materials, and vacuum deposition nitinol fabricated materials. In yet a further embodiment, valve leaflets <NUM> can be made of an ultrahigh molecular weight polyethylene material commercially available under the trade designation DYNEEMA from Royal DSM of the Netherlands. With certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that will prevent or minimize overgrowth. It can be further desirable that the leaflet material is durable and not subject to stretching, deforming, or fatigue.

<FIG> is a schematic illustration showing a partial side view the prosthesis <NUM> implanted at a native mitral valve region of the heart <NUM> in accordance with an embodiment of the present technology. The prosthesis <NUM> is shown in <FIG> having only two support arms <NUM> for purposes of illustration only. It is understood that the prosthesis <NUM>, in some arrangements, can have more than two support arms <NUM>, e.g., greater than six support arms, etc. Generally, when implanted, the upstream portion <NUM> of the valve support <NUM> is oriented to receive blood inflow from a first heart chamber, e.g., left atrium LA for mitral valve MV replacement, left ventricle for aortic valve replacement, etc., and the downstream portion <NUM> is oriented to release blood outflow into a second heart chamber or structure, e.g., left ventricle LV for mitral valve MV replacement, aorta for aortic valve replacement.

In operation, the heart valve prosthesis <NUM> can be intravascularly delivered to a desired native valve region of the heart <NUM>, such as near the mitral valve MV, while in the radially compressed configuration (not shown) and within a delivery catheter (not shown). Referring to <FIG>, the prosthesis <NUM> can be advanced to a position within or downstream of the native mitral valve annulus AN where the support arms <NUM> and the downstream portion <NUM> of the valve support <NUM> are released from the delivery catheter. The delivery catheter can then release the upstream portion <NUM> of the valve support <NUM> and the radially-extending segment <NUM> at a position within or upstream of the native mitral valve MV so as to enlarge toward the radially expanded configuration and engage the native tissue within the native heart valve region. Once released from the delivery catheter, the prosthesis <NUM> can be positioned such that the radially-extending segment <NUM> resides within the left atrium and engages tissue at or near the supra-annular region. The prosthesis <NUM> is further positioned such that the support arms <NUM> engage outward-facing surfaces of the native leaflets LF to capture the leaflets between the support arms <NUM> and the exterior wall <NUM> of the valve support <NUM>. The contact area or landing zone <NUM> of each of the support arms <NUM> is configured to engage tissue at or near the subannular tissue so as to resist movement of the prosthesis <NUM> in an upstream direction during ventricular systole, as is described further herein.

<FIG> is an enlarged sectional view of the heart valve prosthesis <NUM> of <FIG> shown in a radially expanded configuration (e.g., a deployed state) and in accordance with an embodiment of the present technology. In <FIG>, the prosthesis <NUM> is schematically shown positioned at a mitral valve MV on the right-hand side of the illustration. When deployed and implanted, the heart valve prosthesis <NUM> is configured to position the prosthetic valve component <NUM>, which is retained or held within the valve support <NUM>, in a desired location and orientation within the native mitral valve MV. Referring to <FIG> and <FIG> together, several features of the prosthesis <NUM> provide resistance to movement of the prosthesis <NUM>, promote tissue ingrowth, minimize or prevent paravalvular leakage and/or minimize native tissue erosion when implanted in the radially expanded configuration. For example, the radially-extending segment <NUM> 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 a lower surface or apex <NUM> of an arching or S-shaped strut <NUM> can provide a tissue engaging region for contacting the supra-annular tissue, for example to provide sealing against paravalvular leakage and to inhibit downstream migration of the prosthesis <NUM> relative to the native annulus.

In some embodiments, an upward oriented lip portion <NUM> of the struts <NUM> that rise to form the crowns <NUM> can provide further tissue contact zones that can further inhibit downstream movement of the prosthesis <NUM> relative to the native annulus, and inhibit rocking or side-to-side rotation of the prosthesis <NUM> within the native valve during the cardiac cycle, thereby inhibiting paravalvular leakage and assuring alignment of the prosthetic valve component <NUM> within the native annulus. In other embodiments, the radially-extending segment <NUM> can be a flange, a brim, a ring, finger-like projections or other projection into the atrial space for at least partially engaging tissue at or above a supra-annular region thereof.

Referring to <FIG> and <FIG> together, the support arms <NUM> are shown having the curvilinear shape <NUM> and extending from the downstream portion <NUM> of the valve support <NUM>. The support arms <NUM> are configured to engage both the native leaflets (if present) and/or the subannular region of the mitral valve MV within the ventricular space. In one embodiment, the support arms <NUM> are configured to engage an outside surface (e.g., ventricle-facing side) of the leaflet such that the native leaflet is captured between the support arm <NUM> and the exterior wall <NUM> of the valve support <NUM>. In one such embodiment, the preformed curvilinear shape <NUM> of the support arm <NUM>, for example at a transitional apex 144a of the second arcuate region <NUM>, can be biased toward the exterior wall <NUM> of the valve support <NUM> such that a compressive force Fc<NUM> presses the leaflet LF against the exterior wall <NUM> in a manner that pinches, grasps, crimps or otherwise confines the leaflet within the space <NUM> between the support arm <NUM> and the exterior wall <NUM> of the valve support <NUM>.

To further inhibit upstream migration of the prosthesis <NUM> with respect to the native valve annulus AN, the second arcuate region <NUM> is configured to engage the subannular region (e.g., behind the leaflet LF) via the contact area or landing zone <NUM>. In an additional embodiment, the second arcuate region <NUM> can contact tissues below the annulus AN, such as the ventricle wall (as shown in <FIG>). By contacting the subannular region (<FIG> and <FIG>) and/or the tissues below the annulus AN (<FIG>) via, for example, the widened portion <NUM> (<FIG> and <FIG>) that extends to arm tip <NUM>, the landing zone <NUM> distributes surface contact over a larger region to inhibit tissue erosion and to distribute load stress on the support arms <NUM> in an atraumatic manner.

In various arrangements, the curvilinear shape <NUM> of the support arm <NUM> can form a substantially S-shaped profile. In certain arrangements, the support arms <NUM> can be more flexible (e.g., than other portions of the frame <NUM>) and/or be made of resilient material (e.g., shape-memory material, super-elastic material, etc.) that can absorb forces exerted on the support arms <NUM> when implanted in the heart <NUM> and during the cardiac cycle. For example, these forces can cause the substantially S-shaped profile to temporarily deform, deflect or otherwise change shape. Likewise, the curvilinear shape <NUM> of the support arms can provide compressive forces Fc<NUM> in an upstream direction (e.g., at the contact zone <NUM>) and against annulus tissue. In one embodiment, the apex <NUM> (e.g., lower surface) of the radially-extending segment <NUM> can be longitudinally separated from the landing zone <NUM> of the second arcuate region by a gap <NUM>. When implanted, the gap <NUM> can be sized to receive annular tissue therein. In one embodiment, the apex <NUM> of the arching strut <NUM> can provide a downward compressive force Fc<NUM> on the contacted tissue of the annulus that opposes the compressive force FC2 across the gap <NUM>. Accordingly, the compressive forces Fc<NUM> and Fc<NUM> may be aligned and/or opposed to each other such that annular tissue is captured between the radially-extending segment <NUM> and the support arms <NUM> having the preformed curvilinear shape <NUM>. In some embodiments, the struts <NUM> can be circumferentially- and radially-aligned with the second arcuate region <NUM> of the support arms <NUM> such that the compressive force Fc<NUM> is directly opposed to the compressive force Fc<NUM> (shown in <FIG>) to effectively pinch the annulus AN therebetween.

In some embodiments, the portions of the prosthesis <NUM>, such as the radially-extending segment <NUM>, the valve support <NUM> and/or the support arms <NUM> can be provided with a sealing material <NUM> (<FIG>) to cover at least portions of the prosthesis <NUM>. The sealing material <NUM> can prevent paravalvular leakage as well as provide a medium for tissue ingrowth following implantation, which can further provide biomechanical retention of the prosthesis <NUM> in the desired deployment location within the native heart valve region. In some embodiments, the sealing material <NUM> or portions thereof may be a low-porosity woven fabric, such as polyester, DACRON® polyester, or polytetrafluoroethylene (PTFE), which creates a one-way fluid passage when attached to the frame <NUM>. In one embodiment, the sealing material <NUM> or portions thereof may be a looser knit or woven fabric, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface. In another embodiment, polyester velour fabrics may alternatively be used for at least portions of the sealing material <NUM>, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other appropriate cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, AZ, for example. In another embodiment, the sealing material <NUM> or portions thereof may be a natural graft material, such as pericardium or another membranous tissue.

<FIG> are side views of a variety of support arm configurations in accordance with additional embodiments of the present technology. Referring to <FIG> together, the support arm <NUM>, in one embodiment, can generally have the curvilinear shape <NUM> with first and second arcuate regions <NUM>, <NUM> separated by an elongate or substantially straight region <NUM> that together extend substantially in parallel with a longitudinal axis <NUM> (e.g., generally aligned with the longitudinal axis La of the valve support <NUM>; <FIG>). In some embodiments, the support arm <NUM> has an S-shaped profile. As illustrated in <FIG>, the first arcuate region <NUM> can have a first radius of curvature R<NUM> and the second arcuate region <NUM> can have a second radius of curvature R<NUM> that, in certain embodiments, is (a) substantially equal to the first radius of curvature R<NUM> (<FIG>), (b) substantially less than the first radius of curvature R<NUM> (<FIG>), or is (c) substantially greater than the first radius of curvature R<NUM> (<FIG>).

Referring to <FIG> and <FIG> together, the second arcuate region <NUM> can have the tissue engaging portion or contact zone <NUM> for engaging subannular or other cardiac tissue during and/or after deployment. In the embodiments illustrated in FIGS. 6A-6D, the support arm <NUM> includes the arm post <NUM> at a first end 140a and from which the first arcuate region <NUM> generally extends in the outward direction from the longitudinal axis LA, <NUM> and in radial alignment with the downstream portion <NUM> of the valve support <NUM> (<FIG>). The first arcuate region <NUM> curves about a first center of curvature CC1. As shown in <FIG>, the substantially straight or elongate portion <NUM> extends between the first arcuate region <NUM> and the second arcuate region <NUM>. The second arcuate region <NUM> is radially aligned with an intermediate or middle portion <NUM> of the valve support <NUM> between the upstream and downstream portions <NUM>, <NUM> (<FIG>). In one embodiment, the second arcuate region <NUM> curves about a second center of curvature CC2. In the embodiments illustrated in <FIG> and <FIG>, a first axis line (not shown) drawn through the first center of curvature CC1 is parallel to a second axis line (not shown) drawn through the second center of curvature CC2. The first and second axis lines are substantially perpendicular to the longitudinal axis LA, <NUM> (<FIG>).

Referring to <FIG>, and in some embodiments, the arm post <NUM> can be generally linear and have a suitable length L<NUM> for extending the first arcuate region <NUM> a desirable distance downstream from a connection (not shown) to the valve support <NUM>. In some embodiments, the arm post <NUM> can be generally parallel to the longitudinal axis LA of the prosthesis <NUM> and/or valve support <NUM> (shown in <FIG>). Following the general curvature of the first arcuate region <NUM> shown in <FIG>, a first curved segment <NUM> of the region <NUM> extends radially outward from the arm post <NUM>. More particularly, the first curved segment <NUM> may be described as arcuate or generally curved in an outward and downstream direction until it reaches a transitional apex 142a. of the first arcuate region <NUM>. Thereafter a second curved segment <NUM> of the first arcuate region <NUM> continues the curve profile and extends outward and in a generally upstream direction from the transitional apex 142a.

As shown in <FIG>, a first transitional point <NUM> initiates the elongate region <NUM> of the support arm <NUM>, with the elongate region <NUM> slanting and extending in an upward and inward direction relative to the longitudinal axis LA of the valve support <NUM> to end at a second transitional point <NUM>. In similar fashion, the general curvature of the second arcuate region <NUM> initiates as the second transitional point <NUM> such that following the curvature of the second arcuate region <NUM>, a third curved segment <NUM> is defined that generally curves in an outward and upstream direction to reach a transitional apex 144a of the second arcuate region <NUM>. A fourth curved segment <NUM> of the second arcuate region <NUM> continues the curve profile and extends (e.g., relative to the longitudinal axis LA) from the transitional apex 144a in an outward direction and can also curve slightly downstream toward a free-end or arm tip <NUM>. An opening <NUM> between the second arcuate region <NUM> and the first arcuate region <NUM> of the support arm <NUM> is generally created in the space between the third transition <NUM> and the first end 140a of the support arm <NUM>, and can be configured to receive a native leaflet LF and/or chordae tendinae therein. Other embodiments of support arms <NUM> can have curved segments <NUM>, <NUM>, <NUM> and <NUM> with less curvature or greater curvature. Additionally, the embodiments of support arms <NUM> shown in <FIG> and 6A-6D can have an overall height H<NUM> that is less than a height H<NUM> of the valve support <NUM> (<FIG> and <FIG>). Other arrangements and heights are also contemplated. Accordingly, in addition to the radius of curvature R<NUM>, R<NUM> of the first and second arcuate regions <NUM>, <NUM> and/or other geometric features/alterations, the overall height H<NUM> of the support arm <NUM> can be selected to accommodate the anatomy at the desired target location of the heart valve.

Referring again to <FIG>, the first and second arcuate regions <NUM>, <NUM> of the support arm <NUM> can be configured to absorb, translate and/or mitigate distorting forces present within the heart during, for example, systole and diastole. In particular arrangements, the support arms <NUM> have a spring-type response to distorting forces (e.g., physical forces capable of exerting on and changing a contour of the support arm <NUM>). As described in more detail herein, the support arms <NUM> can have multiple hinge points for flexing or absorbing such distorting forces. For example, a first distorting force can be absorbed as a result of the spring-type response of the individual support arms <NUM> in a manner that elastically or reversibly and temporarily distorts the unbiased configuration of the support arm <NUM>. As the first distorting force dissipates (e.g., during the cardiac cycle), the spring-type motion continues with the transition of the support arm contour from the distorted position back to an unbiased configuration. Accordingly, a spring-type response of the support arm <NUM> occurs in a manner that is counter to the first distorting force. In these arrangements, the extent to which the support arm <NUM> is compressed and/or extended is proportional to the distorting force(s) exerted on the support arm. The support arm <NUM> can have a selected stiffness which provides a constant for the distance or delta of distortion (e.g., compression, distention). In certain arrangements, the support arms <NUM> can have constant stiffness along the entire length of the support arm and covering all of the multiple hinge points. In other arrangements, the support arms <NUM> can have variable stiffness along the length of the support arm and encompassing the different hinge points. Such selectivity in the stiffness of the individual support arms <NUM> can provide prosthesis designs to accommodate unique and variable native structures, such as for accommodating variable distorting forces exerted by the native mitral valve region. Variable stiffness may be accomplished in a variety of ways: i) differences in the support arm cross-sectional area, ii) variable cold working of select support arms in the case of conventional elastic-plastic metals (e.g. stainless steel, titanium alloys, cobalt-chromium based alloys), and/or iii) selectively heating or providing a heat treatment of one or more support arms and not others.

In particular embodiments, the shape and/or size of the first and second arcuate regions <NUM>, <NUM> can be selected to accommodate forces, such as radially compressive forces, e.g., exerted by the native annulus and/or leaflets Fa, longitudinal diastolic Fd and systolic Fs forces, hoop stress, etc. Absorption of the distorting forces can serve to prevent translation of those forces to the valve support <NUM> and thereby preserve the coaptation of the prosthetic valve component <NUM>. Additionally, and as further shown in <FIG>, absorption of the distorting forces along the entirety of the support arm <NUM> and/or at several hinge points or locations <NUM> (e.g., transitions 140a, 142a, <NUM>, <NUM> and 144a) distribute the stress caused by the forces, thereby substantially preventing fatigue of the support arms <NUM> and/or minimizing tissue erosion at contacted portions of the native anatomy. In accordance with the present technology, the support arms <NUM> may flex, bend, rotate or twist under the distorting forces while the valve support <NUM> substantially maintains its rigidity and/or original shape (e.g., a generally circular shape).

<FIG> are side views of various support arms <NUM> flexing in response to a distorting force in accordance with further embodiments of the present technology. The degree of flexibility of individual support arms <NUM> may be consistent among all support arms <NUM> of a prosthesis <NUM>, or, alternatively, some support arms <NUM> may be more flexible than other support arms <NUM> on the same prosthesis <NUM>. Likewise, a degree of flexibility of individual support arms <NUM> may be consistent throughout an entire length of the support arm <NUM> or curvature of the first and second arcuate regions <NUM>, <NUM>. In other embodiments, however, the degree of flexibility can vary along the length and/or curvature of each support arm <NUM>.

As shown <FIG>, the first and second arcuate regions <NUM>, <NUM> of the support arms <NUM> may flex relative to the arm post <NUM>, the valve support <NUM> (shown in dotted lines) and/or be configured to alter their arcuate shape(s) in response to varying distorting forces F that can be applied by the surrounding tissue during or after implantation of the prosthesis <NUM>. From a static position (<FIG>), the first arcuate region <NUM> may flex downward to a shape/position 842b (<FIG>) in response to a downward force F<NUM> caused by, for example, chordal load (e.g., from chordal tendinae engaging the first arcuate region <NUM>). In another embodiment, the second arcuate region <NUM> may flex downward and the first arcuate region <NUM> may compress from the static position (<FIG>) to shapes/positions 844c and 842c, respectively (<FIG>), in response to a downward force F<NUM> caused by, for example, a tip load (e.g., from left ventricle pressure). Similarly, the first and second arcuate regions <NUM>, <NUM> may flex or compress inward to shapes/positions 842d, 844d (<FIG>) in response to laterally directed inward forces F3a, F3b caused by, for example, ventricle wall load (e.g., from left ventricle contraction). Engagement of the native annulus by the second arcuate region <NUM>, resulting in force F<NUM>, may flex and compress the second arcuate region <NUM> inward to shape/position 844e, which may also promote a position change in the first arcuate region to position 842e (<FIG>). In some embodiments, the first and second arcuate regions <NUM>, <NUM> may flex, rotate inwardly/outwardly and/or deform in response to the laterally directed forces F3a, F3b, F<NUM>, or downward in response to the generally vertically directed forces F<NUM>, F<NUM>.

In other arrangements, and as shown in <FIG>, the first and second arcuate regions <NUM>, <NUM> shown in a static position in <FIG> may also flex and/or rotate laterally, for example, to positions <NUM>/<NUM> (<FIG>) or <NUM>/<NUM> (<FIG>) in response to a laterally-directed force F<NUM>, by bending at one or more transitions 140a, 142a, <NUM>, <NUM> and 144a (<FIG>), for example, at unique and variable angles off a midline <NUM> such that the arm tips <NUM> may be splayed away from each other.

<FIG> is an enlarged sectional view of the heart valve prosthesis <NUM> of <FIG> shown in a compressed delivery configuration (e.g., a low-profile or radially compressed state) configured in accordance with an embodiment of the present technology. The prosthesis <NUM> can be configured for delivery within a delivery catheter sheath (not shown) in the radially compressed configuration shown in <FIG>. More particularly, in the radially compressed configuration, the radially-extending segment <NUM> can be elongated, folded or otherwise arranged to longitudinally extend in a substantially straightened state from the valve support <NUM>. Additionally, the plurality of support arms <NUM> are longitudinally extended and arranged in a substantially straightened state for percutaneous delivery to the targeted native heart valve. As shown in <FIG>, the support arms <NUM> can extend beyond the second end <NUM> of the valve support <NUM> such that the first arcuate region <NUM> is generally linear and substantially parallel with the longitudinal axis LA, while the second arcuate region <NUM> remains in a curved profile. Upon release of the radial constraint, the support arms <NUM> can move to an outward biased position as the delivery catheter sheath (not shown) is withdrawn and the radially-extending segment <NUM> can self-expand to the radially expanded configuration (<FIG>). Additionally, in the event that the heart valve prosthesis <NUM> needs to be repositioned, removed and/or replaced after implantation, the radially-extending segment <NUM> and the valve support <NUM> can transition from the radially expanded configuration (e.g., the deployed state) (<FIG>) back to the radially contracted configuration (<FIG>) using a catheter device or other lateral retaining sheath.

Access to the mitral valve or other atrioventricular valve can be accomplished through a patient's vasculature in a percutaneous manner. Depending on the point of vascular access, the approach to the mitral valve may be antegrade and may rely on entry into the left atrium by crossing the inter-atrial septum. Alternatively, approach to the mitral valve can be retrograde where the left ventricle is entered through the aortic valve or via a transapical puncture. Once percutaneous access is achieved, the interventional tools and supporting catheter(s) may be advanced to the heart intravascularly and positioned adjacent the target cardiac valve in a variety of manners. For example, the heart valve prosthesis <NUM> may be delivered to a native mitral valve region for repair or replacement of the native valve via a transseptal approach (shown in <FIG>), a retrograde approach through the aortic valve, or via a transapical puncture. Suitable transapical and/or transatrial implantation procedures that may be adapted for use with the heart valve prostheses <NUM> described herein are disclosed in <CIT> to Igor Kovalsky, <CIT>, and <CIT>.

<FIG> is a sectional view of the heart <NUM> illustrating a step of a method of implanting a heart valve prosthesis <NUM> using a transseptal approach in accordance with another embodiment of the present technology. Referring to <FIG>, <FIG> together, the prosthesis <NUM> may be advanced into proximity to the mitral valve MV within a delivery catheter <NUM>. Optionally, a guidewire (not shown) may be used over which the delivery catheter <NUM> may be slidably advanced. A sheath <NUM> of the delivery catheter <NUM>, which contains the prosthesis <NUM> in a radially compressed configuration (shown in <FIG>), is advanced through the mitral valve annulus AN between native leaflets LF, as shown in <FIG>. eferring to <FIG>, the sheath <NUM> is then proximally retracted allowing the prosthesis <NUM> to expand such that the support arms <NUM> are in an outward position spatially separated from the longitudinal axis LA and while the valve support <NUM> remains radially contracted. In this deployment phase, the outward movement of the support arms <NUM> is facilitated by the shape-memory bias of the first arcuate region <NUM>. In this transition phase, the first arcuate region <NUM> can have a third radius of curvature R<NUM> that is greater than the first radius of curvature R<NUM>, whereas the second arcuate region <NUM> continues to have the second radius of curvature R<NUM>. The second arcuate region <NUM> provides for atraumatic engagement of cardiac tissue during all phases of deployment within the Mitral Valve MV (as shown in <FIG>). For example, the second arcuate region <NUM> is configured to deflect in response to contact with chordae tendinae CT when transitioning between the radially contracted configuration and the radially expanded configuration. The second arcuate region <NUM> can also atraumatically engage a wall of the left ventricle LV during deployment and as the support arm <NUM> moves or swings behind the native leaflets LF. When the support arms <NUM> are fully deployed (e.g., <FIG>), the support arms <NUM> are positioned further inwardly relative to the longitudinal axis LA and such that the leaflets LF are engaged between the support arms <NUM> and the valve support <NUM>. The sheath <NUM> may be further retracted to release the valve support <NUM> and the radially-extending segment <NUM> (e.g., within the space of the left atrium LA).

After the sheath <NUM> has been removed and the prosthesis <NUM> allowed to return to its deployed state, the delivery catheter <NUM> can still be connected to the prosthesis <NUM> (e.g., system eyelets, not shown, are connected to the prosthesis eyelets) so that the operator can further control the placement of the prosthesis <NUM> as it expands toward the radially expanded configuration. For example, the prosthesis <NUM> may be expanded upstream or downstream of the target location then pushed downstream or upstream, respectively, into the desired target location before releasing the prosthesis <NUM> from delivery catheter <NUM>. Once the prosthesis <NUM> is positioned at the target site, the delivery catheter <NUM> may be retracted in a proximal direction and the prosthesis <NUM> detached while in the radially expanded configuration at the native target valve (e.g., mitral valve MV).

Claim 1:
A heart valve prosthesis (<NUM>) for implantation at a native valve region of a heart, the prosthesis comprising:
a valve support (<NUM>) having an upstream portion (<NUM>) and a downstream portion (<NUM>), the valve support configured to retain a prosthetic valve component therein;
a plurality of support arms (<NUM>) extending radially outward from the valve support and extending from the downstream portion of the valve support, 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, and wherein in the expanded configuration each of the plurality of support arms has a curvilinear shape with
a first curved region (<NUM>) having a first radius of curvature,
a second curved region (<NUM>) having a second radius of curvature and
an elongate region (<NUM>) extending between the first curved region and the second curved region,
with the first curved region being formed to curve toward the valve support proximate the downstream portion, the elongate region being formed to slant toward the valve support while joining the first curved region and the second curved region, and the second curved region being formed to curve away from the valve support proximate the upstream portion; and
a radially-extending segment (<NUM>) coupled to the upstream portion of the valve support, wherein when the heart valve prosthesis is in the expanded configuration the radially-extending segment is configured to engage a supra-annular surface of the native valve region,
wherein in the expanded configuration atraumatic contact areas (<NUM>) of the second curved regions of the plurality of support arms are configured to oppose the radially-extending segment such that a compressive force is exerted on an annulus at the native valve region by the atraumatic contact areas and the radially-extending segment so as to inhibit movement of the heart valve prosthesis.