Patent Publication Number: US-2021161659-A1

Title: Valve replacement using moveable restraints and angled struts

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
     Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. 
     This application is a continuation of Ser. No. 16/285,566, filed Feb. 26, 2019, which is a continuation application of U.S. patent application Ser. No. 15/829,760, filed Dec. 1, 2017, now granted as U.S. Pat. No. 10,258,466, which is a continuation application of U.S. patent application Ser. No. 15/043,301, filed Feb. 12, 2016, now granted as U.S. Pat. No. 9,848,983, which claims the priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 62/116,248, filed Feb. 13, 2015, the entirety of each of which is hereby incorporated by reference herein for all purposes and forms a part of this specification. 
    
    
     BACKGROUND 
     Field 
     This development relates generally to heart valves, in particular to devices, systems and methods for heart valve replacement. 
     Description of the Related Art 
     Mitral valve disease is typically repaired via invasive surgical intervention or by complicated pinching of the leaflets together creating dual, smaller openings or a mitral valve replacement excluding the native valve. The surgical approach involves risky by-pass surgery, including an opening into the patient&#39;s chest and heart chambers to expose the mitral valve for direct viewing and repair. Resection and partial removal of the patient&#39;s leaflets along with the implantation of a surgical ring like a Carpentier-Edwards Physio, produced by Edwards Life Science, are conventional but complex techniques used by surgeons to reduce the diameter of the patient&#39;s mitral annulus, thus allowing the leaflets to properly coapt and reducing the mitral regurgitate flow. The E-valve catheterization device described in U.S. Pat. No. 7,736,388 B2 and recently approved in the U.S. attempts to duplicate a surgical technique developed by Dr. Ottavio Alfieri where a connection is made across the mitral valve creating dual openings totaling a smaller cross sectional area for blood to flow. This technique often slightly reduces the regurgitate flow but does not provide as durable a solution as the surgical ring implantation. Thus, solutions to mitral valve disease without these drawbacks are needed. 
     SUMMARY 
     The current device may be used as a heart valve replacement. The device includes an implantable frame coupled with a valve comprising one or more valve leaflets. The device may replace a native mitral valve. The device may be delivered via catheterization, for example through a venous access in the groin and trans-septal puncture in the heart accessing the left atrium. The device may be delivered in a collapsed configuration and exposed in the left atrium for expansion. 
     The device may include a closed-shape frame defining an axis therethorugh, with a first side and a second side opposite the first side generally in the axial direction, with a skirt, such as a flared edge, coupled with an end of the frame. The skirt may be a flared edge or edge portions of the frame. The frame may expand. The implantable frame may be coupled with, for example attached to, one or more valve leaflets. The leaflets may be tissue, polymer or other suitable materials. In some embodiments, the leaflets may be coupled with the frame utilizing suturing techniques. 
     The device may include one or more anchors coupled with the frame. The anchors may be elongated rods with piercing features on an end of one or more of the anchors. The anchors may be located circumferentially about the periphery of the frame, for example from the distal or proximal end of the frame. Positive securement of the frame within the mitral valve may be achieved with the anchors engaging native tissue, such as the native valve annulus. The anchors may follow a straight path, a curved path, or combinations thereof, when engaging or engaged with the tissue. The anchors may follow the path of the skirt, such as a flared edge, when engaging or engaged with tissue. 
     The device may include one or more seals. The seal, such as a barrier, ring, cuff or toroid, may be included, for example to prevent leakage around the valve and/or to aid in securement of the implanted frame. 
     In one aspect, an implantable heart valve device is disclosed. The device comprises a tubular frame having a proximal end, a distal end and a central lumen extending therethrough, with the frame comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex. The device further comprises a plurality of distally facing anchors coupled with the frame and configured to embed into tissue surrounding a native mitral valve, a valve coupled with the frame to regulate blood flow through the central lumen, a moveable restraint coupled with the frame and configured to restrain the frame at a desired width and an annular seal carried by the frame, for inhibiting perivalvular leaks. 
     In some embodiments, the annular seal comprises a barrier. The barrier may be located on the interior of the frame. The barrier may be located on the exterior of the frame. 
     In some embodiments, the annular seal comprises a cuff. The cuff may be inflatable. 
     In some embodiments, the annular seal comprises an axially extending barrier and an outwardly radially extending ring. 
     In some embodiments, the leaflets comprise pericardial tissue. 
     In some embodiments, the device further comprises a plurality of connectors, for connecting the valve to the tubular body. 
     In some embodiments, the restraint comprises an aperture for receiving the first pair of adjacent struts. The restraint may comprise a collar. The collar may comprise a threaded surface. The first pair of adjacent struts may comprise a threaded surface. 
     In some embodiments, the restraint comprises a loop carried by the tubular body and surrounding the central lumen. The restraint may be configured to reversibly adjust the implant body radially within a working range. 
     In some embodiments, advancing the collar in an axial direction reduces the angle between the first pair of struts thereby reshaping the implant body. 
     In some embodiments, the anchors are each rotatably carried by the body. 
     In some embodiments, the anchors are configured to be retractable. 
     In some embodiments, the implant body is configured to be reshaped such that a diameter at the proximal end is different from a diameter at the distal end. 
     In some embodiments, the restraint is slidable axially along the first pair of struts. 
     In some embodiments, at least one of the plurality of anchors has a helical shape and rotating the anchor causes the anchor to extend into the tissue. 
     In some embodiments, the device comprises at least four pairs of adjacent struts and at least four apexes. The device may comprise at least four restraints. The device may comprise at least four anchors. 
     In some embodiments, rotation of the anchors axially displaces the anchors with respect to the body. 
     In some embodiments, each strut in an adjacent pair of struts comprises a threaded surface. 
     In some embodiments, the valve comprises at least a first leaflet and a second leaflet. The first and second leaflets may be different sizes to selectively direct the direction of blood flow exiting the valve. The valve may further comprise a third leaflet, wherein the first leaflet is larger than both the second and third leaflets. The first leaflet may be located on the anterior side of the valve. 
     In some embodiments, the distal end of the body comprises a skirt that flares outward away from the lumen. The skirt may flare outward and distally. 
     In some embodiments, the distal end of the body comprises a skirt that flares outward and proximally. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Elements in the figures have not necessarily been drawn to scale in order to enhance their clarity and improve understanding of these various elements and embodiments described herein. Furthermore, elements that are known to be common and well understood to those in the industry are not depicted in order to provide a clear view of the various embodiments described herein, thus the drawings are generalized in form in the interest of clarity and conciseness. 
         FIG. 1A  is a partial cross-section view of the native mitral valve anatomy of a human heart and surrounding features. 
         FIG. 1B  is a detail view of the native mitral valve of  FIG. 1A . 
         FIG. 1C  is a perspective view of a prior art tri-leaflet valve. 
         FIG. 2  is a partial side view of an embodiment of a heart valve device including embodiments of a frame and distally extending anchors. 
         FIG. 3A  is a perspective view of an embodiment of a heart valve device having embodiments of a frame with an angled skirt on a distal end and with distally and outwardly extending anchors located on a distal end of the frame. 
         FIG. 3B  is a perspective view of an embodiment of a heart valve device having embodiments of a frame with an angled skirt on a proximal end and with distally and outwardly extending anchors located on a proximal end of the frame. 
         FIGS. 4A and 4B  are perspective views of different embodiments of anchors that may be used with the various heart valve devices described herein. 
         FIG. 5  is a perspective view of an embodiment of a heart valve device having a frame with a skirt, angled anchors, a mitral valve and an interior annular seal embodied as a barrier. 
         FIG. 6A  is a partial perspective view of an embodiment of a delivery system for delivering and deploying the various heart valve devices described herein using a balloon. 
         FIG. 6B  is a partial perspective view of the system of  FIG. 6A  with the balloon expanded. 
         FIGS. 7A and 7B  are partial perspective views of an embodiment of a heart valve device showing an embodiment of an interface between a frame and anchor. 
         FIG. 7C  is a partial cross-section view of a heart valve device showing an embodiment of a curved interface between a frame and anchor. 
         FIGS. 8A-8B  are various views of embodiments of a heart valve device with a valve having different sized and shaped leaflets configured for re-direction of blood flow exiting the device. 
         FIGS. 8C-8D  are side views of the devices of  FIGS. 8A and 8B  showing embodiments of re-directed flow exiting the devices. 
         FIGS. 8E-8F  are partial cross-section views of a heart mitral valve with the embodiments of a heart valve device implanted therein for re-direction of blood flow entering the left ventricle. 
         FIG. 9  is a partial side view of an embodiment of a heart valve device showing an interface between a frame and anchor, including a coil surrounding a central spike. 
         FIG. 10  is a side view of an embodiment of a heart valve device having an extended frame for extension into the left ventricle and exclusion of the native mitral valve when the device is implanted within the mitral valve annulus. 
         FIG. 11  is a perspective view of an embodiment of a heart valve device having a seal embodied as a woven barrier. 
         FIG. 12  is a perspective view of an embodiment of a heart valve device having an expandable frame with angled portions and a seal embodied as a barrier. 
         FIGS. 13A-13C  are partial cross-section views of a human heart showing an embodiment of a delivery system for delivering a heart valve device having a seal embodied as a ring or cuff, such as a toroid. 
         FIGS. 14A-14B  are partial side views of an embodiment of a heart valve device showing a frame with a closure system including a threaded portion and corresponding moveable restraint embodied as a collar. 
         FIG. 15  is a perspective view of an embodiment of a heart valve device showing a frame with a closure system including threaded portions and selective placement of corresponding moveable restraint embodied as a collars. 
         FIG. 16  is a perspective view of a tool for holding the various heart valve devices described herein for surgical placement or catheter delivery of the devices. 
         FIG. 17  is a perspective view of an embodiment of a tool head that may be used with the tool of  FIG. 16 . 
         FIG. 18  is a perspective view of an embodiment of a heart valve device with an interior annular seal embodied as a barrier and angled anchors for delivery and anchoring of the device from within the left ventricle, showing a delivery system driver coupled with one of the anchors. 
         FIGS. 19A-19B  are top and perspective views respectively of an embodiment of a heart valve device having a frame embodied as a rounded ring. 
         FIG. 19C  is a perspective view of the device of  FIGS. 19A-19B  with a valve. 
         FIGS. 20A-20B  are top and perspective views respectively of an embodiment of a heart valve device having a frame embodied as a “D”-shaped ring. 
         FIG. 20C  is a perspective view of the device of  FIGS. 20A-20B  with a valve. 
         FIGS. 21A-21B  are top and perspective views respectively of an embodiment of a heart valve device having a frame embodied as an oblong ring. 
         FIG. 21C  is a perspective view of the device of  FIGS. 21A-21B  with a valve. 
         FIGS. 22A-22B  are partial top and perspective views respectively of an embodiment of a delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. 
         FIG. 22C  is a perspective view of the system and device of  FIGS. 22A-22B  with a valve coupled with the device. 
         FIG. 23  is a partial perspective view of an embodiment of a piston-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. 
         FIG. 24A-24B  are partial perspective views of an embodiment of a balloon-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. 
         FIG. 25A-25B  are partial perspective views of an embodiment of a rotating shaft-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. 
     
    
    
     DETAILED DESCRIPTION 
     In the following discussion that addresses a number of embodiments and applications, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the embodiments described herein may be practiced. It is to be understood that other embodiments may be utilized and changes may be made without departing from the scope of the disclosure. 
     Various inventive features are described below that can each be used independently of one another or in combination with another feature or features. However, any single inventive feature may not address all of the problems discussed above or only address one of the problems discussed above. Further, one or more of the problems discussed above may not be fully addressed by the features of each embodiment described below. 
     Various embodiments of a heart valve device are described. Related delivery and/or deployment systems are also described. The device may include an expandable frame with anchors to secure the device to native heart tissue. The anchors may be aligned with an axis defined by the frame and/or angled with respect to such axis. The frame may expand and/or be shaped to securely position within a native heart valve annulus, such as the native mitral valve annulus. For instance, the frame when expanded may have a flared end or skirt that facilitates with secure positioning of the device in the heart. The device may also include a barrier for directing blood flow. The device may include a seal to prevent leakage of blood around the device. These are some of the features of the device and systems described herein. 
       FIG. 1A  is a partial cross-section view of the native mitral valve MV and left ventricle LV of a human heart.  FIG. 1B  is a detail view of the native mitral valve MV of  FIG. 1A . The mitral valve MV connects the left ventricle LV and the left atrium (above the mitral valve MV). The mitral valve annulus MVA surrounds the mitral valve MV. The chordae tendineae CT extend from papillary muscle PM of the wall of the left ventricle LV to the leaflets of the mitral valve MV. The aortic valve AV is downstream of the mitral valve MV. During diastole of the left ventricle LV, the mitral valve MV opens to allow blood flow from the left atrium (above the mitral valve MV), through the mitral valve MV, and into the left ventricle. The aortic valve AV closes to prevent blood flow from exiting the left ventricle during ventricular diastole. During ventricular systole, the mitral valve MV closes and the aortic valve AV opens to allow blood flow from the left ventricle, through the aortic valve AV and into the aorta (above the aortic valve AV). 
     As shown in  FIG. 1B , the mitral valve MV includes an anterior leaflet and posterior leaflet surrounding the opening. The opening is surrounded by the mitral valve annulus MVA, a fibrous ring. The two leaflets are joined at an anterior commissure at one end of the opening and a posterior commissure at the opposite end of the opening. 
       FIG. 1C  is a perspective view of a prior art tri-leaflet valve. The tri-leaflet valve is similar to one that would be inserted into a collapsible frame. 
       FIG. 2  is a partial side view of an embodiment of a heart valve replacement device  10  having distally extending anchors  300 . The device  10  may include an expandable frame  100 . In some embodiment, the device  10  may include a valve  200  (see, for example  FIG. 5 ). The valve  200  may be comprised of tissue leaflets coupled with the frame  100 . The device  10  may have one or more distally extending anchors  300  coupled with a distal end  102  of the frame  100  for securing the frame  100  and/or valve  200  within the native annulus. The device  10  may include anti-backout features to secure the device in place, such as a skirt  150  formed from a flared frame  100  end. Alternatively or in addition, the device  10  may have a variety of other securement features, such as anti-counter rotation anchors  300 , curved-path anchors  300 , or outwardly extending/angled anchors  300 , as described herein. 
     The frame  100  may include a proximal end  101  and a distal end  102  that is opposite the proximal end  101 . When implanted, the device  10  may be oriented such that the proximal end  101  may be closer to the left atrium, and the distal end  102  may be closer to the left ventricle. 
     In some embodiments, the frame  100  may be tubular between the proximal end  101  and the distal end  102 . Tubular includes any generally rounded, closed shape. For example, the frame  100  may be circular or non-circular, as described herein. The frame  100  may have a variety of shapes, for example “D”-shaped, oblong, oval, etc., as described herein. The shapes may be chosen in order to match a patient&#39;s anatomy. 
     The frame  100  may include a body  110 . The body  110  may be a tubular structure. The body  110  may define a central lumen extending therethrough between the proximal and distal ends  101 ,  102 . In some embodiments, the body  110  may be formed primarily from one or more wires or segments. The wires or segments may have a variety of cross-sectional configurations, for example round, flat, polygonal, segmented, smooth, sharp, increased area, reduced area, other suitable configurations, or combinations thereof. The wire or segments may form a series of struts of the frame  100 . 
     The body  110  may include the struts  110 A,  110 B,  110 C, as shown in  FIG. 2 . For clarity, other struts in  FIG. 2  are not labelled. The frame  100  may include one or more apexes, which may be formed by adjacent pairs of struts. Each strut in an adjacent pair of struts may comprise a threaded surface, as described herein. As shown, there may be one or more proximal apexes  103  located on the proximal end  101  of the frame  100  and formed, for example, by proximal vertices of the struts  110 A,  110 B,  110 C. There may be one or more distal apexes  104  located on the distal end  102  of the frame  100  and formed, for example, by the struts  110 A and  110 B,  110 B and  110 C, etc. For clarity, not all apexes  103 ,  104  are labelled. There may be at least four pairs of adjacent struts and at least four apexes. 
     The body  110  may be separate portions coupled together. For instance, the frame  100  may be constructed from a plurality of portions of the body  110 , such as one or more struts  110 A,  110 B,  110 C, coupled together. As shown in  FIG. 2 , adjacent struts may be coupled together by one of the anchors  300 . For instance, the strut  110 A may be coupled with the strut  110 B via an anchor  300 . Similarly, the strut  110 B may be coupled with the strut  110 C via another anchor  300 . The remaining struts of the frame  100  may be similarly coupled together. 
     In some embodiments, the frame  100  may include openings for coupling the frame portions together. As shown, the strut  110 A and strut  110 B include openings for a shared anchor  300  to extend through the openings in a rotational path. Other struts may be similarly coupled. The body  110  may also be formed by coupling together separate portions through welding, fusing, pins or screws to construct the frame  100 . 
     In some embodiments, the body  110  may be integral. For example, the body  110  may be formed from the same, monolithic piece of material. In some embodiments, the body  110  may be partially integral. For example, the body  110  may be formed from several strut collections coupled together, with each strut collection including several integral struts. The anchors  300  may be coupled with an integral or partially integral body  110  as described above with respect to a frame  100  composed of separate portions coupled together. 
     The anchors  300  may include a body  320  and head  310 . The body  320  may extend along the length of the anchor  300 . The body  320  may include a piercing end, such as a sharp tip, to pierce and engage tissue. The body  320  may be a coiled configuration as shown. The head  310  may be located on the opposite end of the anchor  300  as the piercing tip. The head  310  may include features for engaging the anchor  300  with a tool, for example for movement of the anchor  300  into tissue to secure the device  10  in place, as further described herein. The anchors  300  may be coupled with the distal end  102  of the frame  102  and extend distally from the distal end  102 , as shown in  FIG. 2 . 
     As shown in  FIG. 2 , the frame  100  may be generally cylindrical in the expanded and/or contracted configuration. The proximal and distal ends  101 ,  102  may generally align with the struts and/or generally along an axis defined by the frame  100 . The anchors  300  may thus extend generally axially and/or in a similar plane as the frame  100 . The anchors  300  may thus extend through the frame  100 , as described, and extend generally parallel to the axis. Thus, the frame  100  and anchors  300  may generally define a cylinder or other extended, tubular three-dimensional volume. 
     In some embodiments, features of a percutaneous aortic valve frame may be included, for example as described in U.S. patent application Ser. No. 12/986,780 to Rowe, filed Jan. 7, 2011, the entire content of which is incorporated herein by reference. In some embodiments, features for an adjustable endolumenal mitral valve  200  ring may be included, for example as described in U.S. patent application Ser. No. 14/562,554 to Lashinski, filed Dec. 5, 2014, the entire content of which is incorporated herein by reference. 
     The frame  100  may be formed from a variety of materials, including but not limited to stainless steel, cobalt chromium, Nitinol, Nitinol alloy, other suitable implantable or implant grade materials, or combinations thereof. The frame  100  may be constructed from a malleable material. The device may be radiolucent, such that the device expansion can be monitored via X-ray or fluoroscopy. Additional markers may be added for better visualization throughout the frame  100 . 
     The frame  100  may have uniform thickness. In some embodiments, the struts  110 A,  110 B,  110 C may have varying thicknesses and/or widths, for example to increase stillness or suppleness in areas of stress. An approximate wall thickness for a tubular frame  100  may be from about 0.20 to about 1.00 millimeters in thickness. The strut  110 A,  110 B,  110 C width may be from about 0.20 millimeters to about 1.00 millimeters. In some embodiments, the strut  110 A,  110 B,  110 C may be about 0.50 millimeters thick. In some embodiments, the strut  110 A,  110 B,  110 C may be about 0.75 millimeters in width. In some embodiments, a variable thickness radially and/or longitudinally may be implemented, for example to allow for a differential stiffness throughout the frame  100 . The thickness or thicknesses of the frame  100  may be achieved by machining, such as grinding, select areas of the frame  100  material, such as the body  110  or struts  110 A,  110 B,  110 C. 
     The frame  100  may have a variable surface topography, including but not limited to surface contours, surface finishes, surface coatings, etc. The desired topography may be accomplished by surface grinding selective areas of the frame  100 . The frame  100  may be electropolished, for example after construction of the frame  100 , for a smooth, passivated surface reducing adverse tissue interactions or reactions to elements of the alloy. These and other methods may also be used to implement the desired thicknesses, as discussed above. 
     In some embodiments, construction of the frame  100  may include laser cutting a pattern in a small tube to define a predictable expansion geometry. Elements of the tubular frame  100  may be removed via cutting laser, such as a Nd:YAG or CO2 laser. For instance, a diamond or sinusoidal pattern may be implemented, for example to allow for expansion and contraction for implantation and delivery. Holes may be drilled into the frame  100  for attaching of attachment features, for example for passing suture therethrough to attach tissue and/or anchors  300 , as further described herein. 
     The frame  100  may be configured to expand. In some embodiments, the frame  100  may be configured to expand via shape memory. For example, the frame  100  may be constructed from a Nitinol alloy and heat-set to a preferred diameter or shape, thus reducing or eliminating the need for a mechanical means for expansion within the deployment site. 
     In some embodiments, the frame  100  may be configured to mechanically expand. For example, the frame  100  expansion may involve actuation. In some embodiments, the frame  100  may be configured to fluidly expand. For example, the frame  100  expansion may involve hydraulic means. In some embodiments, the frame  100  may expand via a combination of mechanical, fluid, and/or other means. For instance, the frame  100  expansion may be via a balloon or linkage to provide an internal, radial force moving the frame  100  from a collapsed configuration to an expanded configuration. Further detail of frame expansion features are provided herein, for example with respect to  FIGS. 22A-25B . 
     The frame  100  may have a non-uniform expansion. Non-uniform expansion of the frame  100  may be designed into the cut pattern. In some embodiments, a non-uniform frame  100  geometry may result, for example for a better fit for each patient. For instance, an elliptical pattern may better fit the mitral valve anatomy, such as the annulus shape, of a particular patient. The elliptical resulting shape may allow, for example, for a preferential final shape, which may be more similar to a GeoForm annuloplasty ring where the Anterior-Posterior dimension is narrower than the Septal-Lateral dimension. In some embodiments, a vertical, geometrical undulation in the device, for example the valve  200  leaflets, may be included, for example to help moving the leaflets to a normal coaptation by raising the posterior leaflet up and in from its fallen and dilated diseased position. 
     The frame  100  may include various drug eluting features, such as coating applied to the frame  100 . The drugs may prohibit or inhibit healing responses of tissue. Such features may include Heparin, thin-film polymer, drug eluting, hydrophilic type, or other suitable coatings or combinations thereof. The coatings may be loaded with a host of drugs and anti-inflammatory agents for proper healing. Pockets, holes or wells may be included in for example cut into, the frame  100 , to form space for loading drugs or coatings for elusion into the surrounding area in the body. 
     The device  10  may include one or more of the anchors  300 . There may be at least four anchors,  300 . There may be fewer or more than four anchors  300 . The anchors  300  may rotate. The anchors  300  may each be rotatably carried by the frame  100 . Rotation of the anchors  300  may axially displace the anchors  300  with respect to the frame body  110 . The anchors  300  may be configured to penetrate tissue, resist bending and/or axial movement, and perform other necessary functions. The anchors  300  may be configured to be retractable. The device  10  may be located within the mitral valve  200  annulus and attached to native tissue via a plurality of anchors  300 . The anchors  300  may be located around the frame  100 , as described herein. The anchors  300  may secure the device  10  from movement relative to adjacent tissue and/or prevent leakage around the device  10 . A variety of anchors  300  may be used to secure the device including for example a plurality of barbed spikes, as described herein. 
     In some embodiments, the anchors  300  may include a rotational screw, either clockwise or counterclockwise. The anchors  300  may be constructed of a wire body  320 , such as round, elliptical, rectangular, other suitable wire, or combinations thereof. The anchors  300  may be polished smooth, may have surface irregularities for example to limit rotation in one direction or both, other suitable features, or combinations thereof. The rotational anchors  300  may be constructed of stainless steel, cobalt chromium, polymers, other suitable implantable or implant grade material, or combinations thereof. 
     The anchors  300  may be coil-shaped, helical, and the like. The helical anchors  300  may be constructed from a wire body  320  having a cross-sectional diameter from about 0.2 millimeters to about 1.0 millimeters. In the coiled configuration, the anchor may have a “coiled diameter” from about 1.0 millimeters to about 3.0 millimeters. The coiled diameter refers to a length approximately equal to the distance across the resulting coil shape formed by the coiled wire as measured perpendicular to an axis defined by the coil. The pitch of the coil may be from about ten threads per inch to about thirty-six threads per inch. The pitch may be constant along the length of the anchor. In some embodiments, the pitch may not be constant along the length of the anchor. The axial length of the anchor, i.e. as measured along the axis, may be various suitable amounts. In some embodiments, the axial length may be from about 2 millimeters to about 10 millimeters. An alternative construction would be to cut a helical pattern into a coiled anchor  300  with similar construction as outlined above. 
     The anchors  300  can be threaded into the frame  100  via openings  130 , such as holes, to pass the anchor through, as discussed in further detail herein, for example with respect to  FIGS. 7A-7B . In some embodiments, the frame  100  may have a single through-hole connection allowing the anchor  300  to rotate freely and move laterally within the hole. In embodiments having the anchor  300  and frame  100  with through-holes, for example as shown in  FIGS. 3B and 5 , the device  10  may draw the frame  100  closer to the tissue when engaged into the tissue and rotated. 
     Connecting and driving the anchors  300  can be accomplished via slotted element, hex driver or similar means. The connection and disconnection means could be pure slot and receiver, fracture-able joint or magnetic connection to hold the anchor  300  to a drive means such as a rotational shaft located outside the patient&#39;s body. The connections could be pre-attached and loaded for delivery or attached in the body reducing the cross sectional diameter by staggering the larger components longitudinally along a delivery catheter. See, for example,  FIGS. 4A-4B . 
     In some embodiments, the anchor  300  may be a threaded rod with raised or cut threads into the periphery. The anchor  300  may function as a more stable element in the tissue resisting bending moments about the connection axis. The additional stiffness and material within the central axis may require additional rotational force to drive the anchor  300  into the tissue but would be a stronger point securement. Constructed from similar material as the coiled anchor  300 , this shape and form could be tapered to ease penetration forces during insertion. 
     A surface modification to the anchor  300  may increase the holding force by resisting its counter rotational direction. Small barbs or surface nicks on the anchor  300  would resist a counter rotation and loosening of the anchor  300  after implantation. These surface modifications could be employed via chemical treatment or a mechanical force to cut or swage into the anchor  300 . 
     The anchors  300  attaching the frame  100  to the surrounding tissue could be parallel to the frame&#39;s  100  central axis or angled outward to direct the anchor  300  into more substantial tissue. An angle from about five degrees to ninety degrees from the central axis may direct the anchors  300  into fibrous, myocardial tissue for additional strength and securement. The angles could change circumferentially depending upon the annulus tissue surrounding the anchor  300 . Specifically, between the trigonal area near the aortic valve AV, the tissue is fibrous but thinner, and therefore a more acute angle could perform better and not penetrate the sinus of the aortic valve AV causing an unwanted leak. Conversely, opposite the trigonal area, a more obtuse angle would be beneficial due to the thicker, more vascularized tissue in this area. Also, a deeper anchor  300  would allow additional penetration into the softer tissue. These angular changes can be incorporated in a proximally located anchor  300  or distally located anchor  300  on the frame  100 . 
     The anchor  300  positions may be variable along the height of the frame  100  to direct the angle of the device  10  and/or anticipate and accommodate the saddle shape of the native mitral valve&#39;s three dimensional shape. 
     The delivery of the device  10  may be via the femoral vein in the groin for a trans-septal entry into the left atrium and down into the mitral valve annulus MVA. The anchors  300  may be inserted into the annulus MVA from the left atrium (above the mitral valve). In some embodiments, delivery may be from a trans-apical entry, for example, where the anchors  300  may not be positioned in the left ventricle LV. 
       FIG. 3A  is a perspective view of an embodiment of the heart valve replacement device  10  having embodiments of the frame  100  with an angled distal end  102 . The device  10  of  FIG. 3A  may have the same or similar features and/or functionalities as the device  10  described with respect to  FIG. 2 , and vice versa. As shown in  FIG. 3A , the device  10  may include distally and outwardly extending anchors  300  located on a distal end of the frame. That is, the anchors  300  are oriented angularly with respect to an axis defined by the frame  100  and/or with respect to a plane defined by the generally tubular portion of the frame  100 . 
     The frame  100  may have anti-backout features, such as the skirt  150 . Such features may include the angled or flared distal end  102  of the frame  100  to trap the frame  100  within the valve  200  annulus from the left ventricle LV. This feature could be a bent portion of the lower laser cut pattern in the frame  100  and actuated at deployment or during the deployment phase, for example as shown in  FIG. 12 . This lower portion of the frame  100  could be angled in an upward direction toward the left atrium resisting movement during the closure of the valve  200 . The blood pressure would act on the closed valve  200 , for example during systole, providing a force in the direction of the left atrium. The flared lower frame  100  portion and/or the anchors  300  would resist this force from dislodging the frame  100  from its intended location. 
       FIG. 3B  is a perspective view of an embodiment of the heart valve device  10  having embodiments of the frame  100  with an angled skirt  150  on the proximal end  101  with distally and outwardly extending anchors  300  located on the proximal end  101  of the frame. The device  10  of  FIG. 3B  may have the same or similar features and/or functionalities as other device  10  described herein, such as the devices  10  described with respect to  FIGS. 2 and 3A , and vice versa. However, as mentioned, in  FIG. 3B  the proximal end  101  is flared to form the skirt  150 . Further, the anchors  300  each extend through an opening at a vertex of the frame  100  at the proximal end  101 . Such an arrangement may allow for implantation of the device  10  from within the left ventricle LV, as further described herein, for example, with respect to  FIG. 18 . 
       FIGS. 4A and 4B  are perspective views of different embodiments of anchors  300  that may be used with the various heart valve devices  10  described herein. The anchors  300  may be rotated thus pulling the device  10  into intimate contact to the surrounding tissue securing it from movement. As shown in  FIG. 4A , the anchor  300  may include the head  310  having a recess  310 A defined therein. A complementary shaped tool, such as a square- or hex-head tool, may be received in the recess  310 A for transmission of rotational forces from the tool to the anchor  300 . As shown in  FIG. 4B , the head  310  may be a generally flat or otherwise uncoiled portion of the anchor body  320  that may be grabbed or otherwise secured by a corresponding tool for similar rotation of the anchor  300 . 
       FIG. 5  is a perspective view of an embodiment of the heart valve device  10  having a frame with the flared skirt  150 , angled anchors  300 , an implant mitral valve  200  and an interior annular seal  400  embodied as a barrier. The device  10  has the valve  200  attached into the frame  100 , with integral anchors  300  at the proximal end  101  of the device  10  and the annular seal  400  to prevent leakage about the device  10 . The valve  200  includes valve leaflets  210 A,  210 B and  210 C. The valve leaflets  210 A,  210 B and  210 C are attached along with the annular seal  400  to prohibit leakage about the device  10 . The seal  400  may include the seal body  410 . The body  410  may be a thin walled structure generally forming a sidewall of the seal  400 . The seal  400  is shown attached to an interior side of the frame  100 . The seal  400  is shown in dashed lines for clarity. In some embodiments, the seal  400  may be attached to an exterior side of the frame  100 . In some embodiments, there may be an interior seal  400  and an exterior seal  400 . The exterior seal  400  may have other configurations and embodiments, such as shown and described with respect to the woven barrier seal  400  of  FIG. 11  or the inflated perivalvular seal  500  of  FIGS. 12 and 13A-13C . 
     The device  10  may include an expandable, implantable frame  100  with tissue leaflets, such as leaflets  210 A,  210 B and  210 C, coupled with, for example attached directly to, the frame  100 . There may only be two leaflets. The device  10  may include a plurality of connectors, for connecting the valve  200  to the frame body  110 . The mitral valve  200  may be shaped and defined by expanding the septal lateral dimension with a tool, for example to provide predictable space to place the device  10 . This shaping may be defined with the frame  100  and allow intimate contact for placement of the anchors  300  in the surrounding tissue. A tool like a Kogan Endocervical Speculum may be used to spread the tissue in an open chest placement but the spreading device may need to be concurrent with the device  10  delivery and therefore be delivered via catheter using a similar means. 
     In some embodiments, the valve  200  may be tissue. Construction of the tissue valve  200  may include cross-linked pericardial bovine or porcine tissue to fixate the material. Examples of chemical fixative agents which may be utilized to cross-link collagenous biological tissues may include, for example, aldehydes (e.g., formaldehyde, glutaraldehyde, dialdehyde starch, para formaldehyde, glyceroaldehyde, glyoxal acetaldehyde, acrolein), diisocyanates (e.g., hexamethylene diisocyanate), carbodiimides, photooxidation, and certain polyepoxy compounds (e.g., Denacol-810, -512, or related compounds). For chemical fixatives, glutaraldehyde may be used. Glutaraldehyde may be used as the fixative for commercially available bioprosthetic products, such as porcine bioprosthetic heart valve (i.e., the Carpentier-Edwards® stented porcine bioprosthesis; Baxter Healthcare Corporation; Edwards CVS Division, Irvine, Calif. 92714-5686), bovine pericardial heart valve prostheses (e.g., Carpentier-Edwards® Pericardial Bioprosthesis, Baxter Healthcare Corporation, Edwards CVS Division; Irvine, Calif. 92714-5686) and stentless porcine aortic prostheses (e.g., Edwards® PRIMA Stentless Aortic Bioprosthesis, Baxter Edwards AG, Spierstrasse 5, GH6048, Horn, Switzerland). 
     In order to incorporate a tissue valve  200  with a stent or other type of frame  100 , a number of different techniques and methods have been used, such as clamping, tying, gluing, or stitching, for example. However, many of the techniques used for this purpose generally produce a stented valve  200  that has concentrated stresses at the points where the leaflets are attached to the stent frame  100 . That is, because the stents are relatively rigid as compared to the flexible material from which the leaflets of the tissue valve  200  are made, the repetitive flexing motion of the leaflets can create stress concentrations at the points where the tissue valve  200  is attached to the stent. These stress concentrations can eventually lead to tearing of the tissue, valve  200  leakage, and/or failure of the heart valve  200 . The attachment points can also be sites for abrasion of the tissue that can lead to tearing of the tissue. Thus, the features described herein provide methods and devices for a durable attachment between a tissue valve  200  and frame  100  to distribute the stresses away from the attachment and seam areas and provide for nonabrasive contact surfaces for bioprosthetic heart valve leaflets. 
     Polymer leaflets could also be used to construct valve  200  leaflets  210 A,  210 B,  210 C with polymers such as polyester, Teflon, urethane and could also be reinforced with strands of stronger materials to strengthen and improve fatigue resistance. Decell tissue anti-calcium treatment could also be added. 
       FIG. 6A  is a partial perspective view of an embodiment of a delivery system  600  for delivering and deploying the various heart valve devices  10  described herein using a balloon  640 .  FIG. 6B  is a partial perspective view of the system of  FIG. 6A  with the balloon  640  expanded. The device  10  may be attached to a steerable delivery system  600  and a central balloon  640  to expand the device  10  radially larger for proper size and positioning. The system  600  may include a delivery tool  610 , which may include a catheter. For example, the system  600  may include a delivery catheter with a centrally mounted balloon  640  for frame  100  expansion and frame  100  connections to hold the device  10  in position during delivery and securement at or around the annulus. The balloon  540  may be expanded to include a first portion  642  located near the tool  610  and a second portion  644  located on the opposite side of the device  10 . The system  600  may include one or more guides  620  for guidance of one or more delivery wires  630 . The wires  630  may attach to the frame  100 , for example at apexes of struts of the frame  100 , such as the struts  110 A,  110 B,  110 C. The wires  630  may attach to the proximal end  101  of the frame  100 . The proximal end  101  may form the skirt  150 , such as a flared end of the frame  100 . The guide  620  may include and/or guide a driver for rotating or otherwise moving the anchors  300 . The driver may couple with the head  310  of the anchors  300  to drive them into the tissue. 
       FIGS. 7A and 7B  are partial perspective views of an embodiment of the heart valve device  10  showing an embodiment of an interface between the frame  100  and anchor  300 . The body  110  of the frame  100  may include openings  130  where the coiled anchor body  310  is passed through to thread the anchor  300 . The frame  100  may be formed from separate portions, such as struts, as discussed. Thus, the coiled anchor  300  may extend through openings  130  in adjacent frame  100  portions to join the two frame  100  portions together. In some embodiments, the frame  100  may be integral, as mentioned. 
     One or more of the anchors  300  may include one or more stoppers  330 . Each anchor  300  could be assembled into the frame  100  and the stopper  330  at the distal end could be installed to resist the anchor  300  from becoming separated from the frame  100 . The proximal portion would limit movement due to the drive head. The stoppers  330  may be located at the proximal and/or distal ends of the anchors  300 . The stoppers  330  may limit rotational movement by means of a raised portion or changing the cross sectional shape of the helix. 
       FIG. 7C  is a partial cross-section view of the heart valve device  10  showing an embodiment of a curved interface interface between the frame  100  and anchor  300 . This interface may be used with the various devices  10  described herein, for example with the skirt  150  of the device  10  discussed with respect to  FIG. 3A . As shown in  FIG. 7C , the frame  100  portion with openings  130  is shown in cross-section for clarity. As shown, a curved or angled coil body  320  of the anchor  300  follows a curved path. This may allow, for example, to direct the rotational drive axis in a different direction or plane than the insertion axis. The rotational or delivery drive axis refers to the direction of the tool used to drive the anchor  300 . The insertion axis refers to the direction in which the anchor  300  is inserted into tissue. This may be helpful, for example, to drive in the same axis as the delivery tool yet force the anchors along a different, secondary axis or direction. Thus, to ease delivery of the anchors  300 , a portion of the frame  100 , such as the skirt  150 , to hold the coiled anchors  300  may be curved or angled to change the driving direction with respect to the tissue insertion direction. The anchor  300  may thus be a flexible member directed through the series of openings  130  in the frame  100 . Alternatively, a tubular member could redirect or angle the coiled anchor  300  in various directions. The rotational/delivery axis and the insertion axis could vary from about five to about ninety degrees from the axis of the annulus of the native mitral valve and/or device  10 . In some embodiments, the rotational/delivery axis and the insertion axis could vary about forty degrees from the axis of the annulus of the native mitral valve and/or device  10 . 
       FIGS. 8A-8F  are various views of embodiments of the heart valve device  10  with the valve  200 , for example the valve leaflets, configured, for example sized and/or shaped, for re-direction of blood flow exiting the device  10 . The native mitral valve directs the flow of blood toward the posterior wall of the left ventricle LV aiding in the conservation of the momentum of the blood, aiding the efficiency of the heart. Conventional surgical valves used in the mitral annulus do not include this efficiency, as the blood flow is directed into the middle of the left ventricle LV. Therefore, in some embodiments, the device  10  described herein directs the blood flow through the implanted device  200  in a way that reproduces the blood flow path of the native mitral valve. 
       FIG. 8A  is a top view of an embodiment of the device  10 . In  FIG. 8B , the image on the right is a top view of an embodiment of the device  10  and the image on the left is a side view of that device  10 .  FIGS. 8C and 8D  are side views of the devices  10  of  FIGS. 8A and 8B  showing embodiments of re-directed flow exiting the devices  10 .  FIGS. 8E-8F  are partial cross-section views of a heart mitral valve with the embodiments of the devices  10  implanted therein for re-direction of blood flow entering the left ventricle LV. 
     As shown in  FIGS. 8A-8B , the valve  200  may include the three leaflets  210 A,  210 B,  210 C. In some embodiments, there may only be two of the leaflets. The device  10  may include the valve  200  with the leaflets configured, for example sized and/or positioned, to direct the blood flow to the posterior of the heart. To re-direct the blood flow, the leaflets  210 A,  210 B, and/or  210 C may thus be different sizes. As shown, the leaflet  210 B may be larger than the leaflets  210 A and  210 B. The leaflet  210 B may be located on the anterior side of the mitral valve MV when implanted. The larger leaflet will not open as much as the other two smaller leaflets, directing the flow toward the smaller leaflets located posteriorly. The same can be done with two larger leaflets and only one smaller leaflet as well by orienting the commissure of the two larger leaflets to the anterior of the native mitral valve. Alternatively or in addition, the blood flow may be re-directed by attaching a portion of the leaflets  210 A,  210 B,  210 C at the shared commissures. The commissure attachment may prevent the leaflets from fully opening, thus directing the outgoing flow. These or other configurations of the valve leaflets, such as the valve leaflets  210 A,  210 B and/or  210 C, may re-direct blood flow exiting the device  10 . 
     The leaflets of the valve  200  may be attached with various methods to achieve the various configurations and functions described herein. Attachment of adjacent leaflets of the valve  200  may be accomplished by conventional stitching using suture such as in an open surgical procedure, or by suture loops or application of clips or other tissue anchors in a percutaneous or trans apical procedure. The attachment zone is preferably adjacent the commissure and extends no more than about 25% and generally no more than about 15% or 10% of the length of the coaptive edges of the leaflets of the valve  200 . The opposing leaflets remain unconnected to each other within a central coaptation zone, allowing the opposing leaflets to remain functioning as a single valve  200 . An attachment zone may be provided at a single end or at both opposing ends of the leaflets. 
     In some embodiments, re-direction of the blood flow may be accomplished with the device  10  by orienting the device  10  when implanted such that blood is directed by the leaflets, such as the leaflets  210 A,  210 B,  210 C, in a particular direction. In some embodiments, the valve  200  may have a particular arrangement of leaflets, such as leaflets  210 A,  210 B and/or  210 C, as discussed, as well as a particular orientation when implanted. For example, the valve  200  may have the arrangement of leaflets  210 A,  210 B,  201 C as shown in  FIGS. 8A-8B  and the device  10  may have an orientation when implanted that may be generally along an axis defined by the native mitral valve. In some embodiments, the device  10  may have an orientation when implanted that may be generally off this axis. Thus, a method of directing the flow toward the posterior wall is to angle the attachment plane of the device  10 , for example with a cylindrical device  10 . The flow can be appropriately directed by adding features to the structure supporting the device  10 , such as the frame  100 , that modify the attachment plane of the implanted device  100 . 
     As shown in  FIGS. 8D and 8F , the expanded frame  100  may define a central longitudinal axis about which the frame  100  is concentrically disposed. For example, the unconstrained expanded configuration of the frame  100  may be cylindrical, frustoconical, or other shapes, and defining the central longitudinal axis. The device  10  may re-direct flow, as mentioned. The flow direction may be generally as shown in  FIGS. 8C and 8E . Further, the direction of flow, whether re-directed or not, may be along a primary flow axis, as shown in  FIGS. 8D and 8F . In some implementations of the device  10 , it may be desirable to establish the primary flow axis inclined posteriorly at an angle “B” with respect to the central longitudinal axis defined by the frame  10 . The primary flow axis is the general direction along which the flow travels into the left ventricle LV after exiting and/or while travelling through the device  10 . The angle “B” between the central longitudinal axis and the primary flow axis may be at least about 5 degrees, and in some implementations at least about 10 degrees, but generally less than about 45 degrees, and in some implementations less than about 20 degrees. Examples embodiments of this angle are shown as angle “B” in  FIGS. 8D and 8F . 
     Deflection of the primary flow axis from the central longitudinal axis may be accomplished in a three leaflet valve, for example the valve  200  including the leaflets  210 A,  210 B,  210 C, by increasing the size of the anterior leaflet, such as the anterior leaflet  210 B. Example embodiments of such a device  10  are shown in  FIGS. 8A and 8B . Enlarging the anterior leaflet, such as the anterior leaflet  210 B, will displace the primary flow axis in the posterior direction. The size of the anterior leaflet, such as the anterior leaflet  210 B, may be increased such that the anterior leaflet  210 B occupies an angle “A” of the circumference of the valve  200 , where the valve, whether circular or otherwise, has a total circumference of 360 degrees. This is shown, for example, in  FIGS. 8A and 8B  (in  FIG. 8B , the image on the right). In some embodiments, the size of the anterior leaflet  210 B may be increased such that the anterior leaflet occupies an angle “A” of at least about 125 degrees of the circumference of the valve  200 . In some embodiments, the anterior leaflet  210 B occupies at least about 135 degrees, or 145 degrees, or 160 degrees, or more, of the circumference of the valve  200 . 
       FIG. 9  is a partial side view of an embodiment of the heart valve device  10  showing an interface between the frame  100  and an anchor  300  including a coil  320  surrounding a central spike  340 . The distal spike  340  may be central to the axis of the coil  320  of the anchor  300  which rotates about the spike  340  to increase the moment, strength and fatigue resistance of the anchor  300 . The spike  240  may be coupled with the frame  100 , such as the distal apex  104 , discussed in further detail herein, for example with respect to  FIGS. 2 and 3A . 
       FIG. 10  is a side view of an embodiment of the heart valve device  10  having an extended frame  100 . The taller frame  100  extends the device  10  lower into the left ventricle LV. The device  10  with extended frame  100  may extend into the left ventricle LV and exclude the native mitral valve when the device  10  is implanted within the mitral valve annulus MVA. The proximal end  101  of the frame  100  may be attached to the valve annulus and the distal end  102  may exclude the native valve. 
       FIG. 11  is a perspective view of an embodiment of the heart valve device  10  having a woven seal  400 . The woven seal  400  includes a woven seal body  410  formed of woven material surrounding the device  10  to prevent leakage around the periphery. The woven material may be constructed of a polymer fabric or a metallic wire to provide more structural integrity. Both means would be of an expandable nature to allow for varying patient anatomy. The woven seal  400  may substitute for the frame  100 . That is, the woven seal  400  may take the place of the frame  100 , providing both structural and sealing capabilities to the device  10 . The anchors  300  may be couple with the woven seal  400  as shown. The woven seal  400  may have the same or similar features and/or functionalities as the frame  100 , such as a flared end or skirt  150 , an exterior seal  500 , etc. 
       FIG. 12  is a perspective view of an embodiment of the heart valve device  10  having an expandable frame  100 . The device  10  has an expandable frame  10  and anchors  300  located on the proximal end  101 . An additional feature may be at the distal end  102  of the frame  100  to point a portion inward and proximal locking the frame  100  to the native valve annulus. The frame  100  may include one or more of the skirts  150 . As shown, a first skirt  150  may be located at the proximal end  101  and include one or more frame tabs  112  with openings therethrough to receive the anchors  300 . A second skirt  150  may be located at the distal end  102  and include one or more angled frame portions  114 . The portions  114  may be located at the distal end  102  of the frame  100  and extend outward and proximally. The portions  114  may expand upon delivery of the device  10  to secure the device  10  within the mitral valve annulus. 
     Depending upon the desired performance of the valve  200 , one or both of two different types of seals may desirably be carried by the valve. As shown in  FIG. 12 , the device  10  may have the seal  400 . As has been described herein, valve replacements in accordance with the present device  10  may include a tubular support frame  100 . Depending upon whether the final implanted position of the frame  100  is primarily extending into the left atrium, or instead extends in the ventricular direction such as to exclude the native leaflets, the anchors  300  may be carried by the proximal end  101  (for example, atrial) or the distal end  102  (for example, ventricular) of the frame  100 . As a consequence, the annulus of the prosthetic valve  200  may be axially displaced along the flow path with respect to the native annulus. To prevent blood flow in the annular space between the annulus of the prosthetic valve  200  and the native annulus, the frame  100  is preferably provided with an annular seal  400 , such as a thin sleeve or membrane, which prevents blood flow through the wall of the frame in between the prosthetic annulus and the native annulus. 
     It may also be desirable to include structure to inhibit perivalvular leaks, for example where blood escapes around the valve  200  and/or device  10 . A perivalvular leak may occur in between the device  10  and the native annulus, due to potential mismatch in the geometry of the native valve orifice and the outside diameter of the device  10 . For the seal  400 , relating to potential leaks through the wall of the frame  100 , an impervious membrane may be carried on the inside of the frame  100  (as shown in  FIG. 12 ), on the outside of the frame  100 , or both. For the seal  500 , relating to inhibiting perivalvular leaks, the barrier or membrane will preferably be carried on the outside surface of the frame  100  as will be apparent to those of skill in the art. Thus a seal  400  or  500  on the outside of the frame  100  may be configured to provide both functions, having an axially extending component to cover at least a portion of the length of the frame  100  including the base of the leaflets, and a radially outwardly extending or extendible component to fill spaces between the frame  100  and the adjacent anatomy. 
     An embodiment of a radially outwardly extending component to fill spaces between the frame  100  and the adjacent anatomy is the annular seal  500  shown in  FIGS. 13A-13C . The seal  500 , such as a sealing ring, may be located outside the frame  100 , for example along a midsection of the frame  100 , to limit leakage about the frame  100  as discussed. In addition or alternatively, the seal  500  may be located inside the frame  100 . The seal  500  may be active where an expansion means, such as an inflation mechanism, may increase the physical size of the seal  500 . Thus, the seal  500  may have a smaller, contracted configuration during delivery and a larger, expanded configuration when implanted. Alternatively, the seal  500  may be passive. For example, the seal  500  may self-expand upon expansion of the device  10  within the heart. The seal  500  may include the radially outwardly extending ring component as shown, but it may also include an axially extending component to act as a barrier, as discussed above. 
       FIGS. 13A-13C  are partial cross-section views of a human heart showing an embodiment of a delivery system  600  for delivering the heart valve device  10 . As shown, the device  10  may include the seal  500 .  FIG. 13A  illustrates the device  10  being delivered veniously from the groin via transeptal puncture to access the left ventricle LV.  FIG. 13B  illustrates the system  600  and device  10  with the anchors  300  inserted into the valve annulus.  FIG. 13C  illustrates the system  600  and the device  10  with the anchors  300  inserted and the rotational anchors  300  disconnected from the delivery catheter  640  with the sealing cuff inflated. Attached to the device  10  in  FIGS. 13A and 13B  are rotational connections  630  to drive the coil anchors  300  and an inflation tube  650  to dimensionally change the seal  500 , to limit or halt perivalvular leak through hydraulic pressure. 
     The seal  500  may be a sealing ring or cuff. The seal  500  may have the general shape of a toroid or the like. To prevent leakage around the frame  100 , the seal  500  may be added between the proximal portion that resides in the left atrium (above the mitral valve) and the left ventricle LV. The seal  500  could be of a passive nature and constructed of woven fabric or velour. An alternative means could utilize a more active seal  500  that is inflated or expanded to meet the surrounding tissue. Construction of the active seal  500  could utilize a fluid solution to hydraulically expand and fill with a saline or polymer solution to harden to a predetermined durometer. The seal  500  could be constructed from a polymer balloon material such as nylon, Pebax or the like, and filled from the handle of the delivery catheter  610 . In some embodiments, the seal  500  comprises an annular skirt, such as a flange or the like, which may be similar to the skirt  150  described with respect to the frame  100 . The skirt of the seal  500  may be attached at one end to the device  10  and inclining radially outwardly in either the proximal or distal direction. The skirt of the seal  500  may be carried by a support structure, such as a plurality of struts. Preferably, the skirt of the seal  500  inclines radially outwardly in the distal direction, so that ventricular pressure tends to enhance the sealing function between the skirt of the seal  500  and the adjacent anatomy. 
     In some embodiments, the seal  500  comprises an annular tube carried on a radially outwardly facing surface of the device  10 , such as a surface of the frame  100 . The tube of the seal  500  may be provided with a fill port, having a valve therein. A fill tube may extend from the deployment catheter, for example the tool  610 , to the fill port of the seal  500 , for placing the tube of the seal  500  into fluid communication with a source of inflation media, by way of an inflation lumen extending throughout the length of the catheter. The annular tube of the seal  500  may be at least partially filled following placement, e.g. implantation, of the device  500  but prior to releasing the device  10  from the deployment catheter. The presence of perivalvular leaks may be investigated by injection of contrast media and observation of the atrium under fluoroscopy. The tube of the seal  500  may be further inflated, or other responsive action may be taken such as repositioning the device  10 , depending upon the observed functionality. Once functionality of the device  10  and level (if any) of perivalvular leakage is deemed satisfactory, the fill tube may be decoupled from the fill port of the tube of the seal  500  and the valve of the fil port closed to retain inflation media therein, and the device  10  released from the deployment catheter. 
       FIGS. 14A-14B  are partial side views of an embodiment of the heart valve device  10  showing the frame  100  with a closure system  140  including a threaded portion  142  and corresponding moveable restraint  144 , such as a collar, at the proximal end  101 . There may be at least four moveable restraints  144 . The moveable restraint  144  may have an aperture for receiving therein a pair of adjacent struts of the frame  100 .  FIG. 14A  illustrates an initial unlocked position of a pair of struts  110 A,  110 B of the body  110  from the frame  100 .  FIG. 14B  illustrates the final locked position of the struts  110 A,  110 B. The restraint  144  may be slidable axially along a pair of struts. Advancing the moveable restraint  144 , such as the collar, in an axial direction reduces the angle between the pair of struts thereby reshaping the frame  100 . As further shown, the pair of struts  110 A,  110 B may have a cable  160  connecting the apexes of the struts  110 A,  110 B at the distal end  102 , where a tension force applied to the cable  160  would draw the two apexes and anchors  300  together along with the associated tissue to which the anchors  300  are imbedded. The cable  160  may be connected to openings  116 A,  116 B in the struts  110 A,  110 B. Additionally, the moveable restraint  144 , such as a collar with an aperture therethorugh, an internally-threaded collar, nut, etc. could lock the position and/or angle of the struts  110 A,  110 B and relieve the tension on the cable  160 . The closure system  140  could be a notched feature to hold as a thread for a nut or a notch to hold the moveable restraint  144  in its desired position resisting opposing motion up the struts  110 A,  110 B. In some embodiments, the frame  100  may be configured to be reshaped such that a width, for example a diameter, at the proximal end  101  is different from a width, for example a diameter, at the distal end  101 . 
     The cable  160  or other tension element connecting adjacent struts may be releasably grasped by a retractor element such as a pull wire extending through the deployment catheter and having a distal hook, or by a suture loop wrapping around the cable  160 . Proximal retraction of the retractor element displaces the cable  160  proximally as illustrated in  FIG. 14B . A proximal retraction element and cable  160  may be provided between each adjacent pair of struts, or every second or third pair of struts, depending upon the desired performance. Alternatively, cable  160  may comprise a lasso construction in which it surrounds the entire frame  100 , or is connected to alternating pairs of adjacent struts. One or both ends of the cable  160  forming the lasso loop may extend proximally through the deployment catheter, so that proximal retraction of the at least one end of cable  160  causes a circumferential reduction in the frame  100 . In an alternate construction, cable  160  surrounds at least a portion of the frame  100  but is constructed such that cable  160  is an integral portion of the frame  100 , and remains attached to the frame  100  post deployment. Circumferential reduction of the frame  100  is accomplished by proximal retraction of a retraction element which is releasably coupled to the cable  160 , such as has been discussed above in connection with  FIG. 14B . 
       FIG. 15  is a perspective view of an embodiment of the heart valve device  10  showing the frame  100  with several closure systems  140 , including threaded portions  142  and selective placement of corresponding collars  144 . Some or all of the anchors  300  and collars  144  could be activated depending upon the patient&#39;s need. Not all of the frame  100  vertices may include the collars  144 . 
       FIGS. 16-17  are perspective views of a tool  700  for holding the various heart valve devices  10  described herein for surgical placement or catheter delivery of the devices  10 . The tool  700  may include a handle  710 , body portions  720 A,  720 B, and corresponding tool heads  730 A,  730 B. The tool  700  may be used for surgical placement of the frame  100 , holding the tool  700  open and/or closed depending upon the position and/or angle of the handle  710  and/or body portions  720 A,  720 B. A similar tool could be constructed for a catheter delivery via transapical or transfemoral. As shown in  FIG. 17 , the tool heads  730 A,  730 B may include receiving portions  731 A,  731 B,  732 A,  732 B. For example, the receiving portion  731 B may receive and hold therein the strut  110 A of the frame body  110 , and the receiving portion  732 B may receive and hold therein the strut  110 B. 
       FIG. 18  is a perspective view of an embodiment of the heart valve device  10  with angled anchors  300  for delivery and anchoring from the left ventricle LV. The device  10  may be delivered and anchored from the left ventricle LV where the anchors  300  may be driven in from below the device  10  in the left ventricle LV. For example, the driver  620  may rotate the anchors  300  from the left ventricle LV. The device  10  may include the seal  400  as shown, such as an interior annular barrier, as discussed in further detail herein. 
     Defining the frame  100  diameter to match the patient&#39;s anatomy can be accomplished by pre-defining a shaped set size using a shaped memory material such as Nitinol or ballooning the malleable frame  100  material to a defined diameter. Other means would be to close the frame  100  dimensions by collapsing the frame  100  using a synching wire wrapped around the diameter and reducing the length of the wire causing a force to change the frame  100  shape and dimensions. Additional means would include a force to change the shape of the struts  110 A,  110 B on the sinusoidal frame  100  including a bending or collaring force about the struts  110 A,  110 B moving the base of the frame  100  closer together and gathering the associated surrounding tissue. Additional means would include cutting threads into the frame struts  110 A,  110 B to mate with the moveable restraint  144 , such as a nut, advanced or rotated over the struts  110 A,  110 B moving the struts closer to one another resulting in a gathering force of the surrounding tissue. Another means would include the cable  160 , thread or other connection between the lower segment of the struts where a tensioning force would move the two struts  110 A,  110 B closer to one another. This force could be a tension in any direction including proximal or distal force to push or pull the cable  160  causing a gathering of the surrounding struts and associated tissue. The connection between the struts could be driven by a threaded means or push/pull mechanism outside the body and through the catheter to the device  10 . 
     Once the struts  110 A,  110 B are pulled closer to one another, the apex of the struts  110 A,  110 B can be locked or secured in place with the moveable restraint  144 , such as a collar or nut, placed over the struts  110 A,  110 B, as described herein. Locking of the struts  110 A,  110 B can be achieved with the closure system  140  to prevent the moveable restraint  144  from moving proximally or loosening relative to the struts  110 A,  110 B, allowing the struts  110 A,  110 B to move away from one another. A small tab may engage a ratchet surface holding the moveable restraint  144  from moving proximally but allowing the moveable restraint  144  to be farther advanced if necessary. Alternatively, the moveable restraint  144  could be a nut threaded over the apex holding the proximity of the two struts  110 A,  110 B close to one another. 
     The device  10  may be shaped using these and other methods to achieve a variety of different shapes and sizes. The moveable restraints  144  may be coupled with the frame  100  and configured to restrain the frame  100  at a desired width, diameter, orientation, shape, etc. Other embodiments of moveable restraints may be implemented, such as loops to cinch the frame  100 , as discussed below. Some of these shapes, sizes, configurations, etc. are described with respect to  FIGS. 19A-25B . 
       FIGS. 19A-19B  are top and perspective views respectively of an embodiment of the heart valve device  10  having the frame  100  embodied as a rounded ring. The device  10  may include a frame  100  having a body  110  with a ring shape. The body  110  may be rounded, for example circular. The device  10 , in its round shape, can be placed in or around the annulus, anchored and cinched to reduce the native annulus diameter, after which the device  10  maintains its original round shape. 
       FIG. 19C  is a perspective view of the device  10  of  FIGS. 19A-19B  with a valve  200 . The device  10  may include a frame  100  embodied as a ring-shaped body  110  coupled with, or configured to couple with, the valve  200 . The frame  100  may have the valve  200  built into it or secondarily attached. The device  10  can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device  10  will maintain its round shape with the valve  200 . 
       FIGS. 20A-20B  are top and perspective views respectively of an embodiment of the heart valve device  10  having a frame embodied as a “D”-shaped ring. The device  10  may include a frame  100  having a body  110  with a “D” shape. The device  10  can be configured, for example shape set, to have the shape of a “D”. The device  10  in its “D” shape, can be placed in the naturally “D” shaped annulus, anchored, and cinched to reduce the native annulus width(s). The straight part of the “D” on the device may better match the natural shape and contour of the annulus along the posterior wall. 
       FIG. 20C  is a perspective view of the device  10  of  FIGS. 20A-20B  with a valve  200 . The device  10  may include a frame  100  having a D-shaped body  110  coupled with, or configured to couple with, the valve  200 . The frame  100  may have the valve  200  built into it or secondarily attached. The device  10  can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device  10  will maintain its D shape with the valve  200 . 
       FIGS. 21A-21B  are top and perspective views respectively of an embodiment of a heart valve device  10  having a frame  100  embodied as an oblong ring. The device  10  may include a frame  100  having a body  110  with an oval-like shape. The body  110  may be rounded in the general shape of an oval, ellipse, or the like. The device  10 , in its oval-like shape, can be placed in or around the annulus, anchored and cinched to reduce the native annulus diameter, after which the device  10  maintains its original oval-like shape. The device  10  can be controlled thru cinching to maintain its oval shape or controlled to constrict to a more circular configuration. Maintaining an oval shape may minimize the amount of cinching required if the apex of the long axis is aligned with the commissures. By stretching the annulus in this direction the anterior-posterior (AP) distance is naturally decreased, which may help reduce any regurgitation. Such cinching, with this and other embodiments, may be done with the moveable restraint  144 , which may be a collar and/or a loop. The restraint  144  may include the loop coupled with and/or carried by the frame  100  and surrounding the central lumen of the frame  100 . The restraint  144  may be configured to reversibly adjust the size/shape of the frame  100  radially within a working range. 
       FIG. 21C  is a perspective view of the device of  FIGS. 21A-21B  with a valve. The device  10  may include a frame  100  having an oval-shaped body  110  coupled with, or configured to couple with, the valve  200 . The frame  100  may have the valve  200  built into it or secondarily attached. The device  10  can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device  10  can maintain an oval shape or other rounded shape based on the amount of cinching. 
       FIGS. 22A-22B  are partial top and perspective views respectively of an embodiment of a delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. The device  10  may include an ovalizing feature and a frame configured to be shaped like an oval. One method for ovalizing a round ring and the annulus is to use a catheter based device to simultaneously stretch them both along the same axis as the commissures. The device may be made of a looped, flat ribbon that has a pre-set bend to it. When the ribbon exits the catheter, the distal end of the loop is pulled in a proximal direction while the proximal end of the ribbon remains stationary. This will force the ribbon into a wide loop and push the device annulus outward at the commissures to create the desired oval shape. The oval ring with a valve  200  either built into it or attached, can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device can maintain either it oval shape, or a rounded shape, based on the amount of cinching. This can be accomplished with a new functional valve  200 . 
       FIG. 22C  is a perspective view of the system and device of  FIGS. 22A-22B  with a valve coupled with the device. The oval ring with an artificial valve  200  either built into it or attached, can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device can maintain either it oval shape, or a rounded shape, based on the amount of cinching. This can be accomplished with a new functional valve  200 . 
     The device  10  may include an ovalizing feature and a frame  100  configured to be shaped like an oval, where the frame  100  is coupled with, or configured to couple with, the valve  200 . The frame  100  may have the valve  200  and/or ovalizing feature built into it or secondarily attached. The device  10  can be placed in the annulus, anchored, and cinched to reduce the native annulus diameter. The device  10  can maintain an oval shape or other rounded shape based on the amount of cinching. 
     Some methods for ovalizing the annulus are described below. Each may be utilized with a delivery catheter. 
       FIG. 23  is a partial perspective view of an embodiment of a piston-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. A pair of opposing shafts with telescoping member can be used to distend the annulus in opposite directions to create an oval. 
       FIG. 24A-24B  are partial perspective views of an embodiment of a balloon-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. A liquid filled balloon with anvil ends and a central shaft connecting them can be used to form an oval annulus. The balloon could also be shaped like a long cylinder with round ends and having the fill port entering in the middle of the long. This type of balloon may also create enough hydraulic force to expand the annulus. 
       FIG. 25A-25B  are partial perspective views of an embodiment of a rotating shaft-based delivery and shaping system for delivering and shaping, for example ovalizing, the various heart valve devices described herein. A device that exits the delivery catheter may maintain an proximal external connection that can apply torque to two opposing shafts. As the shafts turn in opposite directions, they are extended outward and push against the annulus to create an oval. 
     While there has been illustrated and described what are presently considered to be example embodiments, it will be understood by those skilled in the art that various other modifications may be made, and equivalents may be substituted, without departing from claimed subject matter. Additionally, many modifications may be made to adapt a particular situation to the teachings of claimed subject matter without departing from the central concept described herein. Therefore, it is intended that claimed subject matter not be limited to the particular embodiments disclosed, but that such claimed subject matter may also include all embodiments falling within the scope of the appended claims, and equivalents thereof. 
     It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the inventions. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment may be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the inventions are susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the inventions are not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. 
     The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, “up to about,” and “substantially” as used herein include the recited numbers, and also represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount or characteristic. Features of embodiments disclosed herein preceded by a term such as “approximately”, “about”, and “substantially” as used herein represent the feature with some variability that still performs a desired function or achieves a desired result for that feature. 
     With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. 
     It will be understood by those within the art that, in general, terms used herein, are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced embodiment recitation is intended, such an intent will be explicitly recited in the embodiment, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the disclosure may contain usage of the introductory phrases “at least one” and “one or more” to introduce embodiment recitations. However, the use of such phrases should not be construed to imply that the introduction of an embodiment recitation by the indefinite articles “a” or “an” limits any particular embodiment containing such introduced embodiment recitation to embodiments containing only one such recitation, even when the same embodiment includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce embodiment recitations. In addition, even if a specific number of an introduced embodiment recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, embodiments, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.” 
     Although the present subject matter has been described herein in terms of certain embodiments, and certain exemplary methods, it is to be understood that the scope of the subject matter is not to be limited thereby. Instead, the Applicant intends that variations on the methods and materials disclosed herein which are apparent to those of skill in the art will fall within the scope of the disclosed subject matter.