Patent Publication Number: US-11654021-B2

Title: Prosthetic heart valve device and associated systems and methods

Description:
This application is a divisional of U.S. patent application Ser. No. 15/490,047, filed Apr. 18, 2017. The entire contents of application Ser. No. 15/490,047 is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present technology relates generally to prosthetic heart valve devices. Several embodiments of the present technology are well suited for percutaneous repair and/or replacement of native mitral valves. 
     BACKGROUND 
     Heart valves can be affected by several conditions. For example, mitral valves can be affected by mitral valve regurgitation, mitral valve prolapse and mitral valve stenosis. Mitral valve regurgitation is abnormal leaking of blood from the left ventricle into the left atrium caused by a disorder of the heart in which the leaflets of the mitral valve fail to coapt into apposition at peak contraction pressures. The mitral valve leaflets may not coapt sufficiently because heart diseases often cause dilation of the heart muscle, which in turn enlarges the native mitral valve annulus to the extent that the leaflets do not coapt during systole. Abnormal backflow can also occur when the papillary muscles are functionally compromised due to ischemia or other conditions. More specifically, as the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to effect proper closure of the leaflets. 
     Mitral valve prolapse is a condition when the mitral leaflets bulge abnormally up in to the left atrium. This can cause irregular behavior of the mitral valve and lead to mitral valve regurgitation. The leaflets may prolapse and fail to coapt because the tendons connecting the papillary muscles to the inferior side of the mitral valve leaflets (chordae tendineae) may tear or stretch. Mitral valve stenosis is a narrowing of the mitral valve orifice that impedes filling of the left ventricle in diastole. 
     Mitral valve regurgitation is often treated using diuretics and/or vasodilators to reduce the amount of blood flowing back into the left atrium. Surgical approaches (open and intravascular) for either the repair or replacement of the valve have also been used to treat mitral valve regurgitation. For example, typical repair techniques involve cinching or resecting portions of the dilated annulus. Cinching, for example, includes implanting annular or peri-annular rings that are generally secured to the annulus or surrounding tissue. Other repair procedures suture or clip the valve leaflets into partial apposition with one another. 
     Alternatively, more invasive procedures replace the entire valve itself by implanting mechanical valves or biological tissue into the heart in place of the native mitral valve. These invasive procedures conventionally require large open thoracotomies and are thus very painful, have significant morbidity, and require long recovery periods. Moreover, with many repair and replacement procedures, the durability of the devices or improper sizing of annuloplasty rings or replacement valves may cause additional problems for the patient. Repair procedures also require a highly skilled cardiac surgeon because poorly or inaccurately placed sutures may affect the success of procedures. 
     Less invasive approaches to aortic valve replacement have been implemented in recent years. Examples of pre-assembled, percutaneous prosthetic valves include, e.g., the CoreValve Revalving® System from Medtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien® Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valve systems include an expandable frame and a tri-leaflet bioprosthetic valve attached to the expandable frame. The aortic valve is substantially symmetric, circular, and has a muscular annulus. The expandable frames in aortic applications have a symmetric, circular shape at the aortic valve annulus to match the native anatomy, but also because tri-leaflet prosthetic valves require circular symmetry for proper coaptation of the prosthetic leaflets. Thus, aortic valve anatomy lends itself to an expandable frame housing a replacement valve since the aortic valve anatomy is substantially uniform, symmetric, and fairly muscular. Other heart valve anatomies, however, are not uniform, symmetric or sufficiently muscular, and thus transvascular aortic valve replacement devises may not be well suited for other types of heart valves. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, and instead emphasis is placed on illustrating clearly the principles of the present disclosure. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent. For ease of reference, throughout this disclosure identical reference numbers and/or letters are used to identify similar or analogous components or features, but the use of the same reference number does not imply that the parts should be construed to be identical. Indeed, in many examples described herein, identically numbered components refer to different embodiments that are distinct in structure and/or function. The headings provided herein are for convenience only. 
         FIG.  1    is a schematic, cross-sectional illustration of the heart showing an antegrade approach to the native mitral valve from the venous vasculature in accordance with various embodiments of the present technology. 
         FIG.  2    is a schematic, cross-sectional illustration of the heart showing access through the inter-atrial septum (IAS) maintained by the placement of a guide catheter over a guidewire in accordance with various embodiments of the present technology. 
         FIGS.  3  and  4    are schematic, cross-sectional illustrations of the heart showing retrograde approaches to the native mitral valve through the aortic valve and arterial vasculature in accordance with various embodiments of the present technology. 
         FIG.  5    is a schematic, cross-sectional illustration of the heart showing an approach to the native mitral valve using a trans-apical puncture in accordance with various embodiments of the present technology. 
         FIG.  6 A  is a cross-sectional side view and  FIG.  6 B  is a top view schematically illustrating a prosthetic heart valve device in accordance with an embodiment of the present technology. 
         FIGS.  7 A and  7 B  are cross-sectional side views schematically illustrating aspects of delivering a prosthetic heart valve device in accordance with an embodiment of the present technology. 
         FIG.  8    is a top isometric view of a prosthetic heart valve device in accordance with an embodiment of the present technology. 
         FIG.  9 A  is a side view of the prosthetic heart valve device of  FIG.  8   , and  FIG.  9 B  is a detailed view of a portion of the prosthetic heart valve device shown in  FIG.  9 A . 
         FIG.  10    is a bottom isometric view of the prosthetic heart valve device of  FIG.  9 A . 
         FIG.  11    is a side view and  FIG.  12 A  is a bottom isometric view of a prosthetic heart valve device in accordance with an embodiment of the present technology. 
         FIG.  12 B  is an isometric view of a prosthetic heart valve device in accordance with another embodiment of the present technology, and  FIG.  12 C  is a detailed view of a portion of the heart valve device shown in  FIG.  12 B . 
         FIG.  13    is a side view and  FIG.  14    is a bottom isometric view of the prosthetic heart valve device of  FIGS.  11  and  12    at a partially deployed state with respect to a delivery device. 
         FIG.  15    is a bottom isometric view of a valve support for use with prosthetic heart valve devices in accordance with the present technology. 
         FIGS.  16  and  17    are side and bottom isometric views, respectively, of a prosthetic heart valve attached to the valve support of  FIG.  15   . 
         FIGS.  18  and  19    are side views schematically showing valve supports in accordance with additional embodiments of the present technology. 
         FIG.  20    is a schematic view of an arm unit of an anchoring member for use with prosthetic heart valve devices in accordance with the present technology. 
         FIG.  21    is a schematic view of an arm unit of an anchoring member for use with prosthetic heart valve devices in accordance with the present technology. 
         FIG.  22    is a schematic view of a portion of the arm units of  FIGS.  20  and  21    in accordance with the present technology. 
         FIG.  23    is a schematic view of an arm unit of an anchoring member for use with prosthetic heart valve devices in accordance with the present technology. 
         FIGS.  24 A and  24 B  are schematic views showing arms having difference configurations of eyelets for coupling a sealing member to an anchoring member in accordance with the present technology. 
     
    
    
     DETAILED DESCRIPTION 
     Specific details of several embodiments of the technology are described below with reference to  FIGS.  1 - 19   . Although many of the embodiments are described below with respect to prosthetic valve devices, systems, and methods for percutaneous replacement of a native mitral valve, other applications and other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described below with reference to  FIGS.  1 - 19   . 
     With regard to the terms “distal” and “proximal” within this description, unless otherwise specified, the terms can reference a relative position of the portions of a prosthetic valve device and/or an associated delivery device with reference to an operator and/or a location in the vasculature or heart. For example, in referring to a delivery catheter suitable to deliver and position various prosthetic valve devices described herein, “proximal” can refer to a position closer to the operator of the device or an incision into the vasculature, and “distal” can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter). 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 location where blood flows into the device (e.g., inflow region), and distal can refer to a downstream position or a location where blood flows out of the device (e.g., outflow region). 
     Overview 
     Several embodiments of the present technology are directed to mitral valve replacement devices that address the unique challenges of percutaneously replacing native mitral valves and are well-suited to be recaptured in a percutaneous delivery device after being partially deployed for repositioning or removing the device. Compared to replacing aortic valves, percutaneous mitral valve replacement faces unique anatomical obstacles that render percutaneous mitral valve replacement significantly more challenging than aortic valve replacement. First, unlike relatively symmetric and uniform aortic valves, the mitral valve annulus has a non-circular D-shape or kidney-like shape, with a non-planar, saddle-like geometry often lacking symmetry. The complex and highly variable anatomy of mitral valves makes it difficult to design a mitral valve prosthesis that conforms well to the native mitral annulus of specific patients. As a result, the prosthesis may not fit well with the native leaflets and/or annulus, which can leave gaps that allows backflow of blood to occur. For example, placement of a cylindrical valve prosthesis in a native mitral valve may leave gaps in commissural regions of the native valve through which perivalvular leaks may occur. 
     Current prosthetic valves developed for percutaneous aortic valve replacement are unsuitable for use in mitral valves. First, many of these devices require a direct, structural connection between the stent-like structure that contacts the annulus and/or leaflets and the prosthetic valve. In several devices, the stent posts which support the prosthetic valve also contact the annulus or other surrounding tissue. These types of devices directly transfer the forces exerted by the tissue and blood as the heart contracts to the valve support and the prosthetic leaflets, which in turn distorts the valve support from its desired cylindrical shape. This is a concern because most cardiac replacement devices use tri-leaflet valves, which require a substantially symmetric, cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets over years of life. As a result, when these devices are subject to movement and forces from the annulus and other surrounding tissues, the prostheses may be compressed and/or distorted causing the prosthetic leaflets to malfunction. Moreover, a diseased mitral annulus is much larger than any available prosthetic aortic valve. As the size of the valve increases, the forces on the valve leaflets increase dramatically, so simply increasing the size of an aortic prosthesis to the size of a dilated mitral valve annulus would require dramatically thicker, taller leaflets, and might not be feasible. 
     In addition to its irregular, complex shape, which changes size over the course of each heartbeat, the mitral valve annulus lacks a significant amount of radial support from surrounding tissue. Compared to aortic valves, which are completely surrounded by fibro-elastic tissue that provides sufficient support for anchoring a prosthetic valve, mitral valves are bound by muscular tissue on the outer wall only. The inner wall of the mitral valve anatomy is bound by a thin vessel wall separating the mitral valve annulus from the inferior portion of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as those imparted by an expanding stent prostheses, could lead to collapse of the inferior portion of the aortic tract. Moreover, larger prostheses exert more force and expand to larger dimensions, which exacerbates this problem for mitral valve replacement applications. 
     The chordae tendineae of the left ventricle may also present an obstacle in deploying a mitral valve prosthesis. Unlike aortic valves, mitral valves have a maze of cordage under the leaflets in the left ventricle that restrict the movement and position of a deployment catheter and the replacement device during implantation. As a result, deploying, positioning and anchoring a valve replacement device on the ventricular side of the native mitral valve annulus is complicated. 
     Embodiments of the present technology provide systems, methods and apparatus to treat heart valves of the body, such as the mitral valve, that address the challenges associated with the anatomy of the mitral valve and provide for repositioning and removal of a partially deployed device. The apparatus and methods enable a percutaneous approach using a catheter delivered intravascularly through a vein or artery into the heart, or through a cannula inserted through the heart wall. For example, the apparatus and methods are particularly well-suited for trans-septal approaches, but can also be trans-apical, trans-atrial, and direct aortic delivery of a prosthetic replacement valve to a target location in the heart. Additionally, the embodiments of the devices and methods as described herein can be combined with many known surgeries and procedures, such as known methods of accessing the valves of the heart (e.g., the mitral valve or triscuspid valve) with antegrade or retrograde approaches, and combinations thereof. 
     The devices and methods described herein provide a valve replacement device that can be recaptured in a delivery device after being only partially deployed to reposition and/or remove the device. The device also has the flexibility to adapt and conform to the variably-shaped native mitral valve anatomy while mechanically isolating the prosthetic valve from the anchoring portion of the device. Several embodiments of the device effectively absorb the distorting forces applied by the native anatomy. The device has the structural strength and integrity necessary to withstand the dynamic conditions of the heart over time, thus permanently anchoring a replacement valve. The devices and methods further deliver such a device in a less-invasive manner, providing a patient with a new, permanent replacement valve but also with a lower-risk procedure and a faster recovery. 
     Access to the Mitral Valve 
     To better understand the structure and operation of valve replacement devices in accordance with the present technology, it is helpful to first understand approaches for implanting the devices. The mitral valve or other type of atrioventricular valve can be accessed through the patient&#39;s vasculature in a percutaneous manner. By percutaneous it is meant that a location of the vasculature remote from the heart is accessed through the skin, typically using a surgical cut down procedure or a minimally invasive procedure, such as using needle access through, for example, the Seldinger technique. The ability to percutaneously access the remote vasculature is well known and described in the patent and medical literature. Depending on the point of vascular access, access to the mitral valve may be antegrade and may rely on entry into the left atrium by crossing the inter-atrial septum (e.g., a trans-septal approach). Alternatively, access to the mitral valve can be retrograde where the left ventricle is entered through the aortic valve. Access to the mitral valve may also be achieved using a cannula via a trans-apical approach. Depending on the approach, 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, as described herein. 
       FIG.  1    illustrates a stage of a trans-septal approach for implanting a valve replacement device. In a trans-septal approach, access is via the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the inter-atrial septum IAS, and into the left atrium LA above the mitral valve MV. As shown in  FIG.  1   , a catheter  1  having a needle  2  moves from the inferior vena cava IVC into the right atrium RA. Once the catheter  1  reaches the anterior side of the inter-atrial septum IAS, the needle  2  advances so that it penetrates through the septum, for example at the fossa ovalis FO or the foramen ovale into the left atrium LA. At this point, a guidewire replaces the needle  2  and the catheter  1  is withdrawn. 
       FIG.  2    illustrates a subsequent stage of a trans-septal approach in which guidewire  6  and guide catheter  4  pass through the inter-atrial septum IAS. The guide catheter  4  provides access to the mitral valve for implanting a valve replacement device in accordance with the technology. 
     In an alternative antegrade approach (not shown), surgical access may be obtained through an intercostal incision, preferably without removing ribs, and a small puncture or incision may be made in the left atrial wall. A guide catheter passes through this puncture or incision directly into the left atrium, sealed by a purse string-suture. 
     The antegrade or trans-septal approach to the mitral valve, as described above, can be advantageous in many respects. For example, antegrade approaches will usually enable more precise and effective centering and stabilization of the guide catheter and/or prosthetic valve device. The antegrade approach may also reduce the risk of damaging the chordae tendineae or other subvalvular structures with a catheter or other interventional tool. Additionally, the antegrade approach may decrease risks associated with crossing the aortic valve as in retrograde approaches. This can be particularly relevant to patients with prosthetic aortic valves, which cannot be crossed at all or without substantial risk of damage. 
       FIGS.  3  and  4    show examples of a retrograde approaches to access the mitral valve. Access to the mitral valve MV may be achieved from the aortic arch AA, across the aortic valve AV, and into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through a conventional femoral artery access route or through more direct approaches via the brachial artery, axillary artery, radial artery, or carotid artery. Such access may be achieved with the use of a guidewire  6 . Once in place, a guide catheter  4  may be tracked over the guidewire  6 . Alternatively, a surgical approach may be taken through an incision in the chest, preferably intercostally without removing ribs, and placing a guide catheter through a puncture in the aorta itself. The guide catheter  4  affords subsequent access to permit placement of the prosthetic valve device, as described in more detail herein. Retrograde approaches advantageously do not need a trans-septal puncture. Cardiologists also more commonly use retrograde approaches, and thus retrograde approaches are more familiar. 
       FIG.  5    shows a trans-apical approach via a trans-apical puncture. In this approach, access to the heart is via a thoracic incision, which can be a conventional open thoracotomy or sternotomy, or a smaller intercostal or sub-xyphoid incision or puncture. An access cannula is then placed through a puncture in the wall of the left ventricle at or near the apex of the heart. The catheters and prosthetic devices of the invention may then be introduced into the left ventricle through this access cannula. The trans-apical approach provides a shorter, straighter, and more direct path to the mitral or aortic valve. Further, because it does not involve intravascular access, the trans-apical approach does not require training in interventional cardiology to perform the catheterizations required in other percutaneous approaches. 
     Selected Embodiments of Prosthetic Heart Valve Devices and Methods 
     Embodiments of the present technology can treat one or more of the valves of the heart, and in particular several embodiments advantageously treat the mitral valve. The prosthetic valve devices of the present technology can also be suitable for replacement of other valves (e.g., a bicuspid or tricuspid valve) in the heart of the patient. Examples of prosthetic heart valve devices, system components and associated methods in accordance with embodiments of the present technology are described in this section with reference to  FIGS.  6 A- 19   . Specific elements, substructures, advantages, uses, and/or other features of the embodiments described with reference to  FIGS.  6 A- 19    can be suitably interchanged, substituted or otherwise configured with one another. Furthermore, suitable elements of the embodiments described with reference to  FIGS.  6 A- 19    can be used as stand-alone and/or self-contained devices. 
       FIG.  6 A  is a side cross-sectional view and  FIG.  6 B  is a top plan view of a prosthetic heart valve device (“device”)  100  in accordance with an embodiment of the present technology. The device  100  includes a valve support  110 , an anchoring member  120  attached to the valve support  110 , and a prosthetic valve assembly  150  within the valve support  110 . Referring to  FIG.  6 A , the valve support  110  has an inflow region  112  and an outflow region  114 . The prosthetic valve assembly  150  is arranged within the valve support  110  to allow blood to flow from the inflow region  112  through the outflow region  114  (arrows BF), but prevent blood from flowing in a direction from the outflow region  114  through the inflow region  112 . 
     In the embodiment shown in  FIG.  6 A , the anchoring member  120  includes a base  122  attached to the outflow region  114  of the valve support  110  and a plurality of arms  124  projecting laterally outward from the base  122 . The anchoring member  120  also includes a fixation structure  130  extending from the arms  124 . The fixation structure  130  can include a first portion  132  and a second portion  134 . The first portion  132  of the fixation structure  130 , for example, can be an upstream region of the fixation structure  130  that, in a deployed configuration as shown in  FIG.  6 A , is spaced laterally outward apart from the inflow region  112  of the valve support  110  by a gap G. The second portion  134  of the fixation structure  130  can be a downstream-most portion of the fixation structure  130 . The fixation structure  130  can be a cylindrical ring (e.g., straight cylinder or conical), and the outer surface of the fixation structure  130  can define an annular engagement surface configured to press outwardly against the native annulus. The fixation structure  130  can further include a plurality of fixation elements  136  that project radially outward and are inclined toward an upstream direction. The fixation elements  136 , for example, can be barbs, hooks, or other elements that are inclined only in the upstream direction (e.g., a direction extending away from the downstream portion of the device  100 ). 
     Referring still to  FIG.  6 A , the anchoring member  120  has a smooth bend  140  between the arms  124  and the fixation structure  130 . For example, the second portion  134  of the fixation structure  130  extends from the arms  124  at the smooth bend  140 . The arms  124  and the fixation structure  130  can be formed integrally from a continuous strut or support element such that the smooth bend  140  is a bent portion of the continuous strut. In other embodiments, the smooth bend  140  can be a separate component with respect to either the arms  124  or the fixation structure  130 . For example, the smooth bend  140  can be attached to the arms  124  and/or the fixation structure  130  using a weld, adhesive or other technique that forms a smooth connection. The smooth bend  140  is configured such that the device  100  can be recaptured in a capsule or other container after the device  100  has been at least partially deployed. 
     The device  100  can further include a first sealing member  162  on the valve support  110  and a second sealing member  164  on the anchoring member  120 . The first and second sealing members  162 ,  164  can be made from a flexible material, such as Dacron® or another type of polymeric material. The first sealing member  162  can cover the interior and/or exterior surfaces of the valve support  110 . In the embodiment illustrated in  FIG.  6 A , the first sealing member  162  is attached to the interior surface of the valve support  110 , and the prosthetic valve assembly  150  is attached to the first sealing member  162  and commissure portions of the valve support  110 . The second sealing member  164  is attached to the inner surface of the anchoring member  120 . As a result, the outer annular engagement surface of the fixation structure  130  is not covered by the second sealing member  164  so that the outer annular engagement surface of the fixation structure  130  directly contacts the tissue of the native annulus. 
     The device  100  can further include an extension member  170 . The extension member  170  can be an extension of the second sealing member  164 , or it can be a separate component attached to the second sealing member  164  and/or the first portion  132  of the fixation structure  130 . The extension member  170  can be a flexible member that, in a deployed state as shown in  FIG.  6 A , flexes relative to the first portion  132  of the fixation structure  130 . In operation, the extension member  170  provides tactile feedback or a visual indicator (e.g., on echocardiographic or fluoroscopic imaging systems) to guide the device  100  during implantation such that the device is located at a desired elevation and centered relative to the native annulus. As described below, the extension member  170  can include a support member, such as a metal wire or other structure, that can be visualized during implantation. For example, the support member can be a radiopaque wire. 
       FIGS.  7 A and  7 B  are cross-sectional views illustrating an example of the operation of the smooth bend  140  between the arms  124  and the fixation structure  130  in the recapturing the device  100  after partial deployment.  FIG.  7 A  schematically shows the device  100  loaded into a capsule  700  of a delivery system in a delivery state, and  FIG.  7 B  schematically shows the device  100  in a partially deployed state. Referring to  FIG.  7 A , the capsule  700  has a housing  702 , a support  704 , and a top  706 . In the delivery state shown in  FIG.  7 A , the device  100  is in a low-profile configuration suitable for delivery through a catheter or cannula to a target implant site at a native heart valve. 
     Referring to  FIG.  7 B , the housing  702  of the capsule  700  has been moved distally such that the extension member  170 , fixation structure  130  and a portion of the arms  124  have been released from the housing  702  in a partially deployed state. This is useful for locating the fixation structure  130  at the proper elevation relative to the native valve annulus A such that the fixation structure  130  expands radially outward and contacts the inner surface of the native annulus A. However, the device  100  may need to be repositioned and/or removed from the patient after being partially deployed. To do this, the housing  702  is retracted (arrow R) back toward the fixation structure  130 . As the housing  702  slides along the arms  124 , the smooth bend  140  between the arms  124  and the fixation structure  130  allows the edge  708  of the housing  702  to slide over the smooth bend  140  and thereby recapture the fixation structure  130  and the extension member  170  within the housing  702 . The device  100  can then be removed from the patient or repositioned for redeployment at a better location relative to the native annulus A. Further aspects of prosthetic heart valve devices in accordance with the present technology and their interaction with corresponding delivery devices are described below with reference to  FIGS.  8 - 19   . 
       FIG.  8    is a top isometric view of an example of the device  100 . In this embodiment, the valve support  110  defines a first frame (e.g., an inner frame) and fixation structure  130  of the anchoring member  120  defines a second frame (e.g., an outer frame) that each include a plurality of structural elements. The fixation structure  130 , more specifically, includes structural elements  137  arranged in diamond-shaped cells  138  that together form at least a substantially cylindrical ring when freely and fully expanded as shown in  FIG.  8   . The structural elements  137  can be struts or other structural features formed from metal, polymers, or other suitable materials that can self-expand or be expanded by a balloon or other type of mechanical expander. 
     Several embodiments of the fixation structure  130  can be a generally cylindrical fixation ring having an outwardly facing engagement surface. For example, in the embodiment shown in  FIG.  8   , the outer surfaces of the structural elements  137  define an annular engagement surface configured to press outwardly against the native annulus in the deployed state. In a fully expanded state without any restrictions, the fixation structure  130  is at least substantially parallel to the valve support  110 . However, the fixation structure  130  can flex inwardly (arrow I) in the deployed state when it presses radially outwardly against the inner surface of the native annulus of a heart valve. 
     The embodiment of the device  100  shown in  FIG.  8    includes the first sealing member  162  lining the interior surface of the valve support  110 , and the second sealing member  164  along the inner surface of the fixation structure  130 . The extension member  170  has a flexible web  172  (e.g., a fabric) and a support member  174  (e.g., metal or polymeric strands) attached to the flexible web  172 . The flexible web  172  can extend from the second sealing member  164  without a metal-to-metal connection between the fixation structure  130  and the support member  174 . For example, the extension member  170  can be a continuation of the material of the second sealing member  164 . Several embodiments of the extension member  170  are thus a floppy structure that can readily flex with respect to the fixation structure  130 . The support member  174  can have a variety of configurations and be made from a variety of materials, such as a double-serpentine structure made from Nitinol. 
       FIG.  9 A  is a side view,  FIG.  9 B  is a detailed view of a portion of  FIG.  9 A , and  FIG.  10    is a bottom isometric view of the device  100  shown in  FIG.  8   . Referring to  FIG.  9 A , the arms  124  extend radially outward from the base portion  122  at an angle α selected to position the fixation structure  130  radially outward from the valve support  110  ( FIG.  8   ) by a desired distance in a deployed state. The angle α is also selected to allow the edge  708  of the housing  702  ( FIG.  7 B ) to slide from the base portion  122  toward the fixation structure  130  during recapturing. In many embodiments, the angle α is 15°-75°, or more specifically 15°-60°, or still more specifically 30°-45°. The arms  124  and the structural elements  137  of the fixation structure  130  can be formed from the same struts (i.e., formed integrally with each other) such that the smooth bend  140  is a continuous, smooth transition from the arms  124  to the structural elements  137 . This is expected to enable the edge  708  of the housing  702  to more readily slide over the smooth bend  140  in a manner that allows the fixation structure  130  to be recaptured in the housing  702  of the capsule  700  ( FIG.  7 B ). Additionally, by integrally forming the arms  124  and the structural elements  137  with each other, it reduces the potential of breaking the device  100  at a junction between the arms  124  and the structural elements  137  compared to a configuration in which the arms  124  and structural elements  137  are separate components and welded or otherwise fastened to each other.  FIGS.  9 A and  9 B  also show that the device  100  can further include chevron-support struts at the outflow region that extend between the arms  124  at the base  122  of the anchoring member  120 . The chevron-supports at the base  122  do not necessarily have a “smooth bend,” such as the smooth bend  140  at the transition from the arms  124  to the downstream-most portion of the fixation structure  130 . As such, so long as the chevron-supports and other elements of the device  100  project toward the inflow region to allow recapture, certain portions of the device  100 , and the anchoring member  120  in particular, need not have such a smooth bend. 
     Referring to  FIGS.  9 B and  10   , the arms  124  are arranged in V-shaped arm units  125  that each have a pair of arms  124  extending from a bifurcation  127  at the base portion  122 . In this embodiment, the individual arms  124  in each V-shaped arm unit  125  are separated from each other along their entire length from where they are connected to the base portion  122  through the smooth bend  140  ( FIG.  9 A ) to the structural elements  137  of the fixation structure  130 . The individual arms  124  are thus able to readily flex as the edge  708  of the housing  702  ( FIG.  7 B ) slides along the arms  124  during recapturing. This is expected to reduce the likelihood that the edge  708  of the housing  702  will catch on the arms  124  and prevent the device  100  from being recaptured in the housing  702 . 
     In one embodiment, the arms  124  have a first length from the base  122  to the smooth bend  140 , and the structural elements  137  of the fixation structure  130  at each side of a cell  138  ( FIG.  8   ) have a second length. The second length of the structural elements  137  along each side of a cell  138  is less than the first length of the arms  124 . The fixation structure  130  is accordingly less flexible than the arms  124 . As a result, the fixation structure  130  is able to press outwardly against the native annulus with sufficient force to secure the device  100  to the native annulus, while the arms  124  are sufficiently flexible to fold inwardly when the device is recaptured in a delivery device. 
     In the embodiment illustrated in  FIGS.  8 - 10   , the arms  124  and the structural elements  137  are configured such that each arm  124  and the two structural elements  137  extending from each arm  124  formed a Y-shaped portion  142  ( FIG.  10   ) of the anchoring member  120 . Additionally, the right-hand structural element  137  of each Y-shaped portion  142  is coupled directly to a left-hand structural element  137  of an immediately adjacent Y-shaped portion  142 . The Y-shaped portions  142  and the smooth bends  140  are expected to further enhance the ability to slide the housing  702  along the arms  124  and the fixation structure  130  during recapturing. 
       FIG.  11    is a side view and  FIG.  12 A  is a bottom isometric view of a prosthetic heart valve device (“device”)  200  in accordance with another embodiment of the present technology. The device  200  is shown without the extension member  170  ( FIGS.  8 - 10   ), but the device  200  can further include the extension member  170  described above. The base  122  of the device  200  shown in  FIG.  12 A  further includes only a single row of chevron-supports  216  as opposed to the dual-rows of chevron-supports at the base  122  of the device  100  shown in  FIG.  10   . The device  200  further includes extended connectors  210  projecting from the base  122  of the anchoring member  120 . Alternatively, the extended connectors  210  can extend from the valve support  110  ( FIGS.  6 A- 10   ) in addition to or in lieu of extending from the base  122  of the anchoring member  120 . The extended connectors  210  can include a first strut  212   a  attached to one portion of the base  122  and a second strut  212   b  attached to another portion of the base  122 . The first and second struts  212   a - b  are configured to form a V-shaped structure in which they extend toward each other in a downstream direction and are connected to each other at the bottom of the V-shaped structure. The V-shaped structure of the first and second struts  212   a - b  causes the extension connector  210  to elongate when the device  200  is in a low-profile configuration within the capsule  700  ( FIG.  7 A ) during delivery or partial deployment. When the device  200  is fully released from the capsule  700  ( FIG.  7 A ) the extension connectors  210  foreshorten to avoid interfering with blood flow along the left ventricular outflow tract. 
     The extended connectors  210  further include an attachment element  214  configured to releasably engage a delivery device. The attachment element  214  can be a T-bar or other element that prevents the device  200  from being released from the capsule  700  ( FIG.  7 A ) of a delivery device until desired. For example, a T-bar type attachment element  214  can prevent the device  200  from moving axially during deployment or partial deployment until the housing  702  ( FIG.  7 A ) moves distally beyond the attachment elements  214  such that the outflow region of the valve support  110  and the base  122  of the anchoring member  120  can fully expand upon full deployment. 
       FIG.  12 B  is an isometric view of a prosthetic heart valve device  200   a  (“device  200   a ”) in accordance with another embodiment of the present technology, and  FIG.  12 C  is a detailed view of an arm unit of the device  200   a . The device  200   a  is substantially similar to the device  200  shown in  FIG.  12 A , but the device  200   a  includes a plurality of Y-shaped arm units  224  instead of V-shaped arm units. Referring to  FIG.  12 C , the arm units  224  have a trunk  226  and two arms  228  extending from the trunk  226  at a bifurcation  227 . The trunk  226  of each Y-shaped arm unit  224  extends from a single row of chevron-supports  216  at the base  122  of the anchoring member  120 , and the trunks  226  have a length such that the bifurcations  227  are located a distance apart from the base  122 . The arms  228  of the Y-shaped arm units  224  can be slightly shorter than the arms  124  of the V-shaped arm units  125  described above with respect to  FIG.  9 B , but the overall lengths of the Y-shaped and V-shaped arm units  224  and  125  can be about the same. The Y-shaped arm units  224  reduce the amount of metal in the region of the chevron-supports  216  compared to the V-shaped arm units  125 , which reduces the material at the base  122  of the anchoring member  120  so that the device  200   a  can be crimped to a smaller diameter for delivery. Moreover, the Y-shaped arm units  224  are also sufficiently flexible so that the device  200   a  can be resheathed in a capsule of a delivery device.  FIG.  13    is a side view and  FIG.  14    is a bottom isometric view of the device  200  in a partially deployed state in which the device  200  is still capable of being recaptured in the housing  702  of the delivery device  700 . Referring to  FIG.  13   , the device  200  is partially deployed with the fixation structure  130  substantially expanded but the attachment elements  214  ( FIG.  11   ) still retained within the capsule  700 . This is useful for determining the accuracy of the position of the device  200  and allowing blood to flow through the functioning replacement valve during implantation while retaining the ability to recapture the device  200  in case it needs to be repositioned or removed from the patient. In this state of partial deployment, the elongated first and second struts  212   a - b  of the extended connectors  210  space the base  122  of the anchoring member  120  and the outflow region of the valve support  110  ( FIG.  6 A ) apart from the edge  708  of the capsule  702  by a gap G. 
     Referring to  FIG.  14   , the gap G enables blood to flow through the prosthetic valve assembly  150  while the device  200  is only partially deployed. As a result, the device  200  can be partially deployed to determine (a) whether the device  200  is positioned correctly with respect to the native heart valve anatomy and (b) whether proper blood flow passes through the prosthetic valve assembly  150  while the device  200  is still retained by the delivery system  700 . As such, the device  200  can be recaptured if it is not in the desired location and/or if the prosthetic valve is not functioning properly. This additional functionality is expected to significantly enhance the ability to properly position the device  200  and assess, in vivo, whether the device  200  will operate as intended, while retaining the ability to reposition the device  200  for redeployment or remove the device  200  from the patient. 
       FIG.  15    is a bottom isometric view of a valve support  300  in accordance with an embodiment of the present technology. The valve support  300  can be an embodiment of the valve support  110  described above with respect to  FIGS.  6 A- 14   . The valve support  300  has an outflow region  302 , an inflow region  304 , a first row  310  of first hexagonal cells  312  at the outflow region  302 , and a second row  320  of second hexagonal cells  322  at the inflow region  304 . The valve support shown in  FIG.  15    is inverted compared to the valve support  100  shown in  FIGS.  6 A- 14    for purposes of illustration such that the blood flows through the valve support  300  in the direction of arrow BF. In mitral valve applications, the valve support  300  would be positioned within the anchoring member  120  ( FIG.  6 A ) such that the inflow region  304  would correspond to orientation of the inflow region  112  in  FIG.  6 A  and the outflow region  302  would correspond to the orientation of the outflow region  114  in  FIG.  6 A . 
     Each of the first hexagonal cells  312  includes a pair of first longitudinal supports  314 , a downstream apex  315 , and an upstream apex  316 . Each of the second hexagonal cells  322  can include a pair of second longitudinal supports  324 , a downstream apex  325 , and an upstream apex  326 . The first and second rows  310  and  320  of the first and second hexagonal cells  312  and  322  are directly adjacent to each other. In the illustrated embodiment, the first longitudinal supports  314  extend directly from the downstream apexes  325  of the second hexagonal cells  322 , and the second longitudinal supports  324  extend directly from the upstream apexes  316  of the first hexagonal cells  312 . As a result, the first hexagonal cells  312  are offset circumferentially from the second hexagonal cells  322  around the circumference of the valve support  300  by half of the cell width. 
     In the embodiment illustrated in  FIG.  15   , the valve support  300  includes a plurality of first struts  331  at the outflow region  302 , a plurality of second struts  332  at the inflow region  304 , and a plurality of third struts  333 . Each of the first struts  331  extends from a downstream end of the first longitudinal supports  314 , and pairs of the first struts  331  are connected together to form first downstream V-struts defining the downstream apexes  315  of the first hexagonal cells  312 . In a related sense, each of the second struts  332  extends from an upstream end of the second longitudinal supports  324 , and pairs of the second struts  332  are connected together to form second upstream V-struts defining the upstream apexes  326  of the second hexagonal cells  322 . Each of the third struts  333  has a downstream end connected to an upstream end of the first longitudinal supports  314 , and each of the third struts  333  has an upstream end connected to a downstream end of one of the second longitudinal supports  324 . The downstream ends of the third struts  333  accordingly define a second downstream V-strut arrangement that forms the downstream apexes  325  of the second hexagonal cells  322 , and the upstream ends of the third struts  333  define a first upstream V-strut arrangement that forms the upstream apexes  316  of the first hexagonal cells  312 . The third struts  333 , therefore, define both the first upstream V-struts of the first hexagonal cells  312  and the second downstream V-struts of the second hexagonal cells  322 . 
     The first longitudinal supports  314  can include a plurality of holes  336  through which sutures can pass to attach a prosthetic valve assembly and/or a sealing member. In the embodiment illustrated in  FIG.  15   , only the first longitudinal supports  314  have holes  336 . However, in other embodiments the second longitudinal supports  324  can also include holes either in addition to or in lieu of the holes  336  in the first longitudinal supports  314 . 
       FIG.  16    is a side view and  FIG.  17    is a bottom isometric view of the valve support  300  with a first sealing member  162  attached to the valve support  300  and a prosthetic valve  150  within the valve support  300 . The first sealing member  162  can be attached to the valve support  300  by a plurality of sutures  360  coupled to the first longitudinal supports  314  and the second longitudinal supports  324 . At least some of the sutures  360  coupled to the first longitudinal supports  314  pass through the holes  336  to further secure the first sealing member  162  to the valve support  300 . Sutures  360  can also pass through the holes  336  if holes  336  are included in addition to or in lieu of the holes  336  of the first longitudinal supports  314 . 
     Referring to  FIG.  17   , the prosthetic valve  150  can be attached to the first sealing member  162  and/or the first longitudinal supports  314  of the valve support  300 . For example, the commissure portions of the prosthetic valve  150  can be aligned with the first longitudinal supports  314 , and the sutures  360  can pass through both the commissure portions of the prosthetic valve  150  and the first sealing member  162  where the commissure portions of the prosthetic valve  150  are aligned with a first longitudinal support  314 . The inflow portion of the prosthetic valve  150  can be sewn to the first sealing member  162 . 
     The valve support  300  illustrated in  FIGS.  15 - 17    is expected to be well suited for use with the device  100  and  200  and described above with reference to  FIGS.  8 - 10  and  11 - 14   , respectively. More specifically, the first struts  331  cooperate with the base of the anchoring member  122 . The first struts  331 , for example, elongate when the valve support  300  is not fully expanded compared to when the valve support is fully expanded. In addition to the elongation of the struts, the position of the prosthetic valve  150  within the valve support  300  allows the outflow portion of the prosthetic valve  150  to be spaced further apart from the capsule  700  in a partially deployed state so that the prosthetic valve  150  can at least partially function in the partially deployed state. Alternatively, if attached to the device  200 , the extended connectors  210  ( FIGS.  11 - 14   ) of the device  200  serve to further separate the outflow portion of the prosthetic valve  150  from the capsule  700  ( FIGS.  13 - 14   ) when the device  200  is in a partially deployed state, allowing for partial function of the prosthetic valve  150 . Upon full deployment, the first struts  331  foreshorten. Therefore, the valve support  300  is expected to enhance the ability to assess whether the prosthetic valve  150  is fully operational in a partially deployed state. This additional functionality is expected to significantly enhance the ability to assess, in vivo, whether the device  100  and  200  will operate as intended, while retaining the ability to reposition the device  100  and  200  for redeployment or remove the device  100  and  200  from the patient. 
       FIGS.  18  and  19    are schematic side views of valve supports  400  and  500 , respectively, in accordance with embodiments of the present technology. The valve support  400  includes a first row  410  of first of hexagonal cells  412  and a second row  420  of second hexagonal cells  422 . The valve  400  can further include a first row  430  of diamond-shaped cells extending from the first hexagonal cells  412  and a second row  440  of diamond-shaped cells extending from the second hexagonal cells  422 . The additional diamond-shaped cells elongate in the low-profile state, and thus they can further space the prosthetic valve  150  (shown schematically) apart from the capsule of the delivery device, enhancing the ability to assess, in vivo, whether the device will operate as intended while retaining the ability to reposition or remove the device from the patient. Referring to  FIG.  19   , the valve support  500  includes a first row  510  of first hexagonal cells  512  at an outflow region  502  and a second row  520  of second hexagonal cells  522  at an inflow region  504 . The valve support  500  is shaped such that an intermediate region  506  has a smaller cross-sectional area than that of the outflow region  502  and/or the inflow region  504 . As such, the first row  510  of first hexagonal cells  512  flares outwardly in the downstream direction and the second row  520  of second hexagonal cells  522  flares outwardly in the upstream direction. The flared outflow and inflow regions  502  and  504  are expected to improve blood flow through the valve support  500 . Additionally, the flared outflow and inflow regions  502  and  504  reduce the length of the valve support compared to a straight cylindrical design, which reduces the amount that the valve support  500  extends into the left ventricle. 
       FIG.  20    is a schematic view showing a portion of an anchoring member  120  in accordance with an embodiment of the present technology. In this embodiment, the anchoring member  120  includes the fixation structure  130  and V-shaped arm units  620  (only a single arm unit shown). Each V-shaped arm unit  620  includes a pair of arms  622  extending from the base  122  to the fixation structure  130  (only a portion shown), and each arm  622  includes a first portion  624  having a first flexibility and a second portion  626  with a second flexibility less than the first flexibility. The first portion  624  of the arms  622  are selectively flexible at the base  122  of the anchoring member  120 , while the second portion  626  of the arms  622  have sufficient stiffness to push the fixation structure  130  radially outwardly for engaging the native annulus. In the illustrated embodiment, the first portion  624  of the arms  622  are a serpentine member (e.g., an according connector), and the second portion  626  of the arms  622  are straighter than the first portion  624 . For example the second portion  626  of the arms  622  can curve radially outward along an arc (e.g. a single arc) as opposed to the serpentine or the zig-zag configuration of the first portion  624 . 
       FIG.  21    is a schematic view showing a portion of another anchoring member  120  in accordance with an embodiment of the present technology including Y-shaped arm units  720  (only a single arm unit  720  shown). Each Y-shaped arm unit  720  has a trunk  724  and arms  726  extending from the trunk  724 . The trunk  724  has a first flexibility, and the arms  726  have a second flexibility less than the first flexibility. The trunk  724 , for example, is a strut having a serpentine configuration (e.g., an accordion connector), and the arms  726  can be curved struts extending radially outward from the trunk  724  in an expanded configuration. 
       FIG.  22    schematically illustrates the operation of the arm units  620  and  720  shown in  FIGS.  20  and  21   . In operation, the native annulus (not shown) exerts a compressive annulus force F A  against the fixation structure  130  while the systolic pressure creates a force F P . The additional flexibility of the first portion  624  or the trunk  724  allows the arm units  620  and  720  to preferentially flex near the outflow end of the valve support  110  to allow the fixation structure  130  to be deformed by the native annulus while mitigating the commissure forces Fc exerted against the valve support  110  at the base  122 . Notably, the second portion  626  of the arms  622  and the arms  726  are sufficiently stiff to provide the desired radially outward force against the native annulus for securing the prosthetic heart valve device at the native heart valve. 
       FIG.  23    illustrates an arm  800  supporting a fixation structure  130  in accordance with another embodiment of the present technology. The arm  800  can include a first portion  820  configured to be coupled to the outflow region of a valve support and a second portion  822  extending from the first portion  820  to the fixation structure  130 . The first portion  820  of the arm  800  can correspond to the first portion  624  of the arms  622  of the V-shaped arm unit  620  or the trunk  724  of the Y-shaped arm unit  720 . The first portion  820  of the arm  800  can further include a plurality of outward recesses  824  (e.g., notches) that enable the first portion  822  preferentially flex outward (arrow O). The arm  800  is expected to perform substantially similarly to the arms  622  and the Y-shaped arm unit  720  described above with reference to  FIGS.  20 - 22   . 
       FIGS.  24 A and  24 B  are schematic views showing arms  124  having difference configurations of eyelets  900  for coupling the second sealing member  164  ( FIGS.  6 A and  6 B ) to the anchoring member  120 . Referring to  FIG.  24 A , the eyelets  900  are on the outside of the arms  124 . Referring to  FIG.  24 B , the eyelets are on the inside of the arms  124 . In both embodiments, sutures  902  pass through the eyelets to attach the second sealing member  164  to the inside of the anchoring member  120 . The embodiment shown in  FIG.  24 B  is particularly well-suited for resheathing the prosthetic heart valve devices because the eyelets are shape-set to extend inwardly to eliminate or otherwise limit protrusions relative to the outer surface of the arms  124  that could inhibit the capsule from sliding over the arms  124  during resheathing. 
     EXAMPLES 
     Several aspects of the present technology described above are embodied in the following examples.
     1. A prosthetic heart valve device for treating a native valve of a human heart having a native annulus and native leaflets, comprising:
       a valve support having an inflow region and an outflow region;   a prosthetic valve assembly within the valve support; and   an anchoring member having a base attached to the outflow region of the valve support, a plurality of arms projecting laterally outward from the base and inclined in an upstream direction in a deployed state, and a fixation structure extending upstream from the arms, the fixation structure having a plurality of struts that define an annular engagement surface configured to press outwardly against the native annulus and a plurality of fixation elements projecting from the struts, wherein a downstream-most portion of the fixation structure extends from the arms at a smooth bend and fixation elements at the downstream-most portion of the fixation structure extend in an upstream direction.   
       2. The prosthetic heart valve device of example 1 wherein the arms are spaced apart from each other throughout their length.   3. The prosthetic heart valve device of any of examples 1-2 wherein the struts of the fixation structure are arranged in cells having sides, and the arms have a first length and each side of the cells has a second length less than the first length.   4. The prosthetic heart valve device of any of examples 1-3 wherein each arm and the struts of the fixation structure extending from each arm form a Y-shaped portion of the anchoring member, and a right-hand strut of each Y-shaped portion is coupled directly to a left-hand strut of an immediately adjacent Y-shaped portion.   5. The prosthetic heart valve device of any of examples 1-4, further comprising connector extensions projecting from a downstream end of the valve support and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the valve support and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.   6. The prosthetic heart valve device of any of examples 1-5 wherein all of the fixation elements projecting from the fixation structure extend in an upstream direction.   7. The prosthetic heart valve device of any of examples 1-6 wherein the valve support comprises:
       a first row of first hexagonal cells at the outflow region of the valve support, and the first hexagonal cells having first longitudinal supports;   a second row of second hexagonal cells at the inflow region of the valve support, the second hexagonal cells having second longitudinal supports, wherein the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and   wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.   
       8. The prosthetic heart valve device of example 7 wherein the valve support further comprises a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.   9. The prosthetic heart valve device of example 7 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.   10. The prosthetic heart valve device of example 7, further comprising connector extensions projecting from a downstream end of the valve support and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the valve support and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.   11. The prosthetic heart valve device of any of examples 1-10 wherein the valve support comprises:
       a first row of first hexagonal cells at the outflow region of the valve support, wherein the first hexagonal cells have first longitudinal supports, first upstream V-struts extending upstream from the first longitudinal supports, and first downstream V-struts extending downstream from the first longitudinal supports;   a second row of second hexagonal cells at the inflow region of the valve support, wherein the second hexagonal cells have second longitudinal supports, second upstream V-struts extending upstream from the second longitudinal supports, and second downstream V-struts extending downstream from the second longitudinal supports; and   wherein the first upstream V-struts of the first hexagonal cells and the second downstream inverted V-struts of the second hexagonal cells are the same struts.   
       12. A prosthetic heart valve device for treating a native valve of a human heart having a native annulus and native leaflets, comprising:
       an annular inner support frame having an inflow region and an outflow region;   a prosthetic valve assembly within the inner support frame; and   an anchoring member having a base attached to the outflow region of the inner support frame, a plurality of arms projecting laterally outward from the base at an angle inclined in an upstream direction, and an outer fixation frame extending upstream from the arms, the outer fixation frame having a plurality of struts that define an annular engagement surface spaced radially outward from the inflow region of the inner support frame in the deployed state, wherein the arms and the struts are configured to be partially deployed from a capsule and then at least substantially recaptured within the capsule by moving at least one of the capsule and/or the device relative to the other such the arms and struts slide into the capsule.   
       13. The prosthetic heart valve device of example 12 wherein the arms are spaced apart from each other throughout their length.   14. The prosthetic heart valve device of any of examples 12-13 wherein the struts of the outer fixation frame are arranged in cells having sides, and the arms have a first length and each side of the cells has a second length less than the first length.   15. The prosthetic heart valve device of any of examples 12-14 wherein each arm and the struts of the outer fixation frame extending from each arm form a Y-shaped portion of the anchoring member, and a right-hand strut of each Y-shaped portion is coupled directly to a left-hand strut of an immediately adjacent Y-shaped portion.   16. The prosthetic heart valve device of any of examples 12-15, further comprising connector extensions projecting from a downstream end of the inner annular support frame and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the inner annular support frame and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.   17. The prosthetic heart valve device of any of examples 12-16, further comprising fixation elements projecting from the outer fixation frame, and wherein all of the fixation elements project from the outer fixation frame extend in an upstream direction.   18. The prosthetic heart valve device of any of examples 12-17 wherein the inner annular support frame comprises:
       a first row of first hexagonal cells at the outflow region of the inner annular support frame, and the first hexagonal cells having first longitudinal supports;   a second row of second hexagonal cells at the inflow region of the inner annular support frame, the second hexagonal cells having second longitudinal supports, wherein the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and   wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.   
       19. The prosthetic heart valve device of example 18 wherein the inner annular support frame further comprises a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.   20. The prosthetic heart valve device of example 18 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.   21. The prosthetic heart valve device of example 18, further comprising connector extensions projecting from a downstream end of the inner annular support frame and/or the base, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the inner annular support frame and/or the base, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.   22. The prosthetic heart valve device of any of examples 1-21 wherein the arms are arranged in pairs defining V-shaped arm units.   23. The prosthetic heart valve device of example 22 wherein the V-shaped arm units have a pair of arm, and each arm has a first portion having a first flexibility and a second portion having a second flexibility less than the first flexibility.   24. The prosthetic heart valve device of example 23 wherein the first portion has a serpentine configuration.   25. the prosthetic heart valve device of example 23 wherein the first portion has outwardly open notches.   26. The prosthetic heart valve device of any of examples 1, 3-12 and 14-21 wherein the arms are arranged in Y-shaped arm units having a trunk and a pair of arms extending from the trunk.   27. The prosthetic heart valve device of examples 26 wherein the trunk has a first flexibility and the arms have a second flexibility less than the first flexibility.   28. The prosthetic heart valve device of example 27 wherein the trunk has a serpentine configuration.   29. The prosthetic heart valve device of example 27 wherein the trunk has a plurality of outwardly open notches.   30. A method of deploying a prosthetic heart valve device for treating a native heart valve, comprising:
       partially deploying a prosthetic heart valve device from a capsule of a delivery device such that an inflow region of a valve support and an inflow region of a fixation structure are expanded radially outward relative to the capsule with the inflow region of the fixation structure being spaced radially outward of the valve support, wherein an outflow region of the valve support and/or the fixation structure remains within the capsule, and wherein a gap exists between a downstream end of a prosthetic valve within the valve support and a distal terminus of the capsule such that fluid can flow through the valve while the outflow region is within the capsule; and   recapturing the prosthetic heart valve device within the capsule.   
       31. The method of example 30 wherein the native heart valve is a native mitral valve.   32. The method of example 30 wherein the native heart valve is a native aortic valve.   33. A valve support for a prosthetic heart valve, comprising:
       a first row of first hexagonal cells at an outflow region of the valve support, wherein the first hexagonal cells have first longitudinal supports, first and second upstream struts extending upstream from the first longitudinal supports, and first and second downstream struts extending downstream from the first longitudinal supports;   a second row of second hexagonal cells at an inflow region of the valve support, wherein the second hexagonal cells have second longitudinal supports, first and second upstream struts extending upstream from the second longitudinal supports, and first and second downstream struts extending downstream from the second longitudinal supports; and   wherein the first and second upstream struts of the first hexagonal cells and the first and second downstream struts of the second hexagonal cells are the same struts.   
       34. The valve support of example 33 wherein the first and second longitudinal supports have a first width and the first and second upstream struts and the first and second downstream struts have a second width less than the first width.   35. The valve support of any of examples 33-34 wherein:
       the first and second hexagonal cells are directly adjacent to each other such that the first longitudinal supports extend directly from downstream apexes of the second hexagonal cells and the second longitudinal supports extend directly from upstream apexes of the first hexagonal cells; and   wherein the prosthetic valve assembly is attached to at least one of the first longitudinal supports and/or at least one of the second longitudinal supports.   
       36. The prosthetic heart valve device of any of examples 33-35 wherein the valve support further comprises a first row of diamond-shaped cells at a downstream end of the first row of hexagonal cells and a second row of diamond-shaped cells at an upstream end of the second row of hexagonal cells.   37. The prosthetic heart valve device of any of examples 33-36 wherein the first row of hexagonal cells flares outward in the downstream direction and the second row of hexagonal cells flares outward in the upstream direction.   38. The prosthetic heart valve device of any of examples 33-37, further comprising connector extensions projecting from a downstream end of the first hexagonal cells, and wherein each connector extension has first and second struts forming a V-shaped structure extending downstream from the first hexagonal cells, and a connector projecting downstream from the V-shaped structure, wherein the connector is configured to be releasably held by a delivery device.   

     From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the invention. For example, several individual components can be interchange with each other in the different embodiments. Accordingly, the invention is not limited except as by the appended claims.