Patent Publication Number: US-2021177592-A1

Title: Heart valve prostheses including torque anchoring mechanisms and delivery devices for the heart valve prostheses

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/421,817, filed Feb. 1, 2017, now U.S. Pat. No. 10,905,550, the contents of which are incorporated by reference herein in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to systems and methods for percutaneous implantation of a heart valve prosthesis. More particularly, it relates to the systems and methods for anchoring a stented prosthetic heart valve via transcatheter implantation. 
     BACKGROUND 
     Heart valves are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve replacement via surgical procedure is often used for patients suffering from valve dysfunctions. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications. 
     To address these concerns, efforts have been made to perform cardiac valve replacements using minimally invasive techniques. In these methods, laparoscopic instruments are employed to make small openings through the patient&#39;s ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician&#39;s ability to access only certain regions of the heart using laparoscopic instruments. 
     Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally invasive surgical methods. In such methods, a heart valve prosthesis is compacted for delivery in a delivery device, also known as a delivery catheter and then advanced, for example through an opening in the native vasculature, and through to the heart, where the heart valve prosthesis is then deployed in the valve annulus (e.g., the mitral valve annulus). 
     Various types and configurations of heart valve prostheses are available for percutaneous valve replacement procedures. In general, heart valve prosthetic designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures. Heart valve prostheses are generally formed by attaching a bioprosthetic valve to a frame made of a wire or a network of wires. Such heart valve prostheses can be contracted radially to introduce the heart valve prosthesis into the body of the patient percutaneously through a delivery device (catheter). The heart valve prosthesis can be deployed by radially expanding it once positioned at the desired target site. 
     It is important the heart valve prostheses are properly anchored at the desired implantation site. In some situations, for example and not by way of limitation, the native mitral valve, it may be difficult to properly anchor the heart valve prosthesis. This may lead to unwanted migration of the heart valve prosthesis and/or paravalvular leakage (PVL). 
     Accordingly, there is a need for improved anchoring mechanisms for heart valve prostheses and methods to more securely anchor heart valve prostheses implanted via transcatheter delivery devices. 
     SUMMARY OF THE INVENTION 
     Embodiments hereof relate to a delivery device for delivery and deployment of a heart valve prosthesis with a torque anchoring mechanism to the site of a damaged or diseased native valve. The delivery device includes a balloon having a first uninflated configuration and a second inflated configuration. The balloon includes a shaped end that is configured to engage a corresponding shaped end of the heart valve prosthesis, and is configured to rotate about a central longitudinal axis of the delivery device. The balloon is configured to rotate the corresponding shaped end of the heart valve prosthesis. 
     Embodiments hereof also relate to a delivery device for delivery and deployment of a heart valve prosthesis to the site of a damaged or diseased native valve. The delivery device includes an inner shaft coupled to a handle and a tether shaft disposed above the inner shaft. The tether shaft includes a proximal shaft portion and a plurality of tethers extending from a distal portion of the proximal shaft portion. The tethers are configured to engage the proximal shaft portion of the tether shaft to the end of the heart valve prosthesis. The tether shaft is rotatable about the inner shaft and configured to correspondingly rotate the tethers and at least a portion of the heart valve prosthesis. 
     Embodiments hereof also relate to a method for deploying and anchoring a heart valve prosthesis with a torque anchoring mechanism at a desired implantation site. The method includes delivering the heart valve including the torque anchoring mechanism in a radially compressed configuration, in a delivery device to the desired implantation site. The heart valve prosthesis is expanded at the desired location to a radially expanded configuration. The delivery device is rotated, rotating at least a portion of the heart valve prosthesis and embedding the torque anchoring mechanism into tissue at the desire implantation site. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a perspective illustration of an embodiment of a heart valve prosthesis with a torque anchoring mechanism according to an embodiment hereof. 
         FIG. 2  is a side view illustration of an embodiment of a delivery device according to an embodiment hereof. 
         FIG. 3  is an exploded perspective illustration of the delivery device of  FIG. 2 . 
         FIG. 4  is a side cutaway illustration of the delivery device of  FIG. 2 . 
         FIG. 5  is a cross section illustration of the delivery device of  FIG. 2  taken along line  5 - 5  of  FIG. 4 . 
         FIG. 6A  a side cutaway illustration of the delivery device of  FIG. 2  in a delivery configuration. 
         FIG. 6B  is a side cutaway illustration of the delivery device of  FIG. 2  with the capsule retracted and the balloon in an inflated configuration. 
         FIG. 7A  is a side cutaway illustration of another embodiment of a delivery device in a delivery configuration. 
         FIG. 7B  is a side cutaway illustration of the delivery device of  FIG. 7A  with the capsule retracted and the balloon in an inflated configuration. 
         FIG. 8A  is a side cutaway illustration of another embodiment of a delivery device in a delivery configuration including a second balloon in an uninflated configuration. 
         FIG. 8B  is a side cutaway illustration of the delivery device of  FIG. 8A  with the capsule retracted and the balloons in an inflated configuration. 
         FIG. 9A  is a side cutaway illustration of another embodiment of a delivery device in a delivery configuration, wherein the delivery device includes a dumbbell-shaped balloon. 
         FIG. 9B  is a side cutaway illustration of the delivery device of  FIG. 9A  with the capsule retracted and the dumbbell-shaped balloon in an inflated configuration. 
         FIG. 10A  is a side cutaway illustration of another embodiment of a delivery device in a delivery configuration, wherein the delivery device includes a balloon. 
         FIG. 10B  is a side cutaway illustration of the delivery device of  FIG. 10A  with the capsule retracted and the balloon in an inflated configuration. 
         FIG. 100  is an end illustration of the balloon of  FIG. 10B . 
         FIGS. 11A-11D  are illustrations of another embodiment of a heart valve prosthesis including a torque anchoring mechanism. 
         FIGS. 12A-12B  are end views of the heart valve prosthesis of  FIGS. 10A-10C  in a pre-deployment configuration and a deployed configuration. 
         FIG. 12C  is an end view of an alternative embodiment of the heart valve prosthesis of  FIGS. 11A-11C . 
         FIG. 13  is a perspective illustration of a heart valve prosthesis with a torque anchoring mechanism according to another embodiment hereof. 
         FIG. 14  is an exploded perspective illustration of an embodiment of a delivery device according to an embodiment hereof. 
         FIG. 15  is a side view illustration of the delivery device of  FIG. 14 . 
         FIG. 16  is a side illustration of the delivery device of  FIG. 14  and heart valve prosthesis of  FIG. 13 . 
         FIG. 17  is an exploded perspective illustration of an embodiment of a delivery device according to an embodiment hereof. 
         FIG. 18  is a side view illustration of the delivery device of  FIG. 17 . 
         FIG. 19  is a side illustration of the delivery device of  FIG. 17  and heart valve prosthesis of  FIG. 13 . 
         FIGS. 20-24  are schematic illustrations of a method of delivering a heart valve prosthesis. 
         FIGS. 25-29  are schematic illustrations of another method of delivering a heart valve prosthesis. 
         FIGS. 30-34  are schematic illustrations of another method of delivering a heart valve prosthesis. 
         FIG. 35  is a schematic illustration of another embodiment of a heart valve prosthesis including a torque anchoring mechanism. 
         FIG. 36  is a schematic cross-section of a variation of the heart valve prosthesis of  FIG. 35 . 
     
    
    
     DETAILED DESCRIPTION 
     Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal”, when used in the following description to refer to a catheter or delivery device, are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positions distant from, or in a direction away from, the clinician and “proximal” and “proximally” refer to positions near, or in a direction toward, the clinician. When the terms “distal” and “proximal” are used in the following description to refer to a device to be implanted into a vessel, such as a heart valve prosthesis, they are used with reference to the direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow and “proximal” and “proximally” refer to an upstream direction with respect to the direction of blood flow. 
     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description. 
     As referred to herein, a heart valve prosthesis used in accordance with and/or as part of the various systems, devices, and methods of the present disclosure may include a wide variety of different configurations, such as a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. 
     In general terms, the heart valve prosthesis, or stented prosthetic heart valve as it is sometimes referred to, of the present disclosure includes a frame supporting a valve structure (tissue or synthetic), with the frame having a normal, radially expanded configuration that is collapsible to a radially compressed configuration for loading within or on a delivery device. The stent is may be constructed to self-deploy or expand when released from the delivery device, or may be balloon-expandable. 
       FIG. 1  shows an embodiment of a heart valve prosthesis  10 .  FIG. 1  illustrates heart valve prosthesis  10  in a radially expanded configuration. Heart valve prosthesis  10  includes a frame  14  and a prosthetic valve  12  coupled to the frame  14 . Heart valve prosthesis  10  includes a radially collapsed configuration and the radially expanded configuration. Heart valve prosthesis  10  also includes a first end  26  and a second end  32  opposite first end  26 . Frame  14  is generally tubular and defines a central passage  24 , and includes a first end  34  and a second end  36 . In the embodiment shown in  FIG. 1 , first end  34  of frame  14  defines first end  26  of heart valve prosthesis  10 . Similarly, second end  36  of frame  14  defines second end  32  of heart valve prosthesis  10 . Those skilled in the art would recognize that other features, such as skirts or arms may be included as part of heart valve prosthesis  10 . In the embodiment shown, first end  26  of heart valve prosthesis  10  is the proximal or inflow end, and second end  32  of heart valve prosthesis  10  is the distal or outflow end. Also, first end  34  of frame  14  is flared radially outwardly, as show in  FIG. 1 . This outward flare at first end  34  forms an inflow rim  15  that is configured to contact an atrial side of a native mitral valve annulus. Further, although inflow rim  15  is shown as generally circular, inflow rim may be other shapes to conform to the anatomy adjacent the native mitral valve, such as but not limited to D-shaped. A portion of frame  14  may also be described as an outflow portion  25 . Outflow portion  25  is generally tubular and is configured to extend through the leaflets of the native valve complex. Although heart valve prosthesis  10  as shown is configured for placement at the site of a native mitral valve, heart valve prosthesis  10  may be used at other implantation sites, such as, but not limited to, sites of other native heart valves. 
     Frame  14  is a support structure that comprises struts  16  arranged relative to each other with a plurality of open spaces  17  there between. Frame  14  provides a desired compressibility and expansion force at the desired implantation site. Frame  14  also provides support for prosthetic valve  12 . Prosthetic valve  12  is coupled to and disposed within frame  14 . In the embodiment of  FIG. 1 , a radially outward portion of inflow rim  15  bends such that the radially outward portion of inflow rim  15  extends generally longitudinally away from second end  36  of frame  14 . Struts  16  of inflow rim  15  bend and form a plurality of peaks  18  and valleys  20  at a first end of inflow rim  15 . 
     A plurality of torque anchoring mechanisms  22  are coupled to inflow rim  15 . In the embodiment shown in  FIG. 1 , torque anchoring mechanism  22  are coupled to valleys  20  of inflow rim  15 , but may be coupled to other portions of inflow rim  15 . Torque anchoring mechanisms  22  are configured such that when heart valve prosthesis  10  is in the radially expanded configuration at a desired implantation site, and at least a portion of heart valve prosthesis  10  is rotated, torque anchoring mechanisms  22  are embedded into tissue at the desired implantation site. As shown in  FIG. 1 , torque anchoring mechanisms  22  extend clockwise. However, they may extend counter-clockwise or partially angled in either direction. Further, torque anchoring mechanisms  22  may generally extend from an underside  19  of inflow rim  15 . The underside  19  of inflow rim  15  is the surface facing the native mitral valve annulus when the heart valve prosthesis  10  is deployed with inflow rim  15  on the atrial side of the native mitral valve annulus (i.e., the surface of the inflow rim facing the outflow end). Torque anchoring mechanisms  22  may be barbs, clips, hooks, arrows or similar devices configured to embed into tissue at the desired implantation site. While  FIG. 1  shows each torque anchoring mechanism  22  as single wire, this is not limiting and other configurations of torque anchoring mechanisms may be used. 
     Frame  14  may be formed, for example, and not by way of limitation, of nickel titanium alloys (e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), cobalt-chromium-tungsten-nickel alloys (L605), stainless steel, high spring temper steel, or any other metal or suitable for purposes of the present disclosure. Torque anchoring mechanisms  22  may be formed from the same types of materials as frame  14 . Torque anchoring mechanisms  22  may be extensions of struts  16 , or may be coupled to frame  14 , for example, and not by way of limitation, by fusing, welding, adhesive, sutures, snap-fit, interference fit, other mechanical engagements, or other means suitable for the purposed described herein. 
     With the above understanding of heart valve prosthesis  10  in mind, a delivery device  100  consistent with components, methods, and procedures of the current disclosure is shown in  FIGS. 2-5 . In an embodiment, delivery device  100  generally includes a handle  140 , an outer shaft assembly  110  including a capsule  107 , an inner shaft assembly  104 , and a balloon  150  (not shown in  FIG. 2 ). Delivery device  100  may be any standard construction delivery device, such as, but not limited to, multi-lumen or coaxial construction delivery devices. In other embodiments, capsule  107  is not required, such as when using a balloon expandable heart valve prosthesis, or a self-expandable heart valve prosthesis with other means to maintain the heart valve prosthesis in a radially collapsed configuration. A guidewire lumen  123  is disposed through inner shaft assembly  104  such that delivery device  100  may be advanced over a guidewire (not shown) disposed within guidewire lumen  123 . Delivery device  100  may be made from any suitable material, such as, but not limited to polyethylene (PE), polyethylene terephthalate (PET), polyether block amide (PEBA, such as PEBAX®), nylons, polyurethanes, polyvinylchloride (PVC), and metal hypotubes such as stainless steel. 
     Delivery device  100  is used for percutaneously delivering, implanting, and anchoring heart valve prosthesis  10  with torque anchoring mechanisms  22  according to an embodiment of the present invention.  FIG. 2  illustrates an embodiment of delivery device  100  with heart valve prosthesis  10  in the radially collapsed configuration disposed within capsule  107  of outer shaft assembly  110 . In other embodiments, heart valve prosthesis  10  may be mounted on a balloon without a capsule, or a self-expandable heart valve prosthesis may be mounted with other means to maintain the heart valve prosthesis in a radially collapsed configuration. Delivery device  100  and heart valve prosthesis  10  are configured such that when heart valve prosthesis  10  is positioned at a desired implantation site and in the radially expanded configuration, rotating delivery device  100  rotates at least a portion of heart valve prosthesis  10 , and torque anchoring mechanism  22  is embedded in tissue at the implantation site, as will be described in greater detail herein. 
     Components in accordance with an exemplary embodiment of delivery device  100  of  FIG. 2  are presented in greater detail in  FIGS. 3-6B . Various features of the components of delivery device  100  reflected in  FIGS. 2-6B  and described below can be modified or replaced with differing structures and/or mechanisms. The components of delivery device  100  may assume different forms and construction. Therefore, the following detailed description is not meant to be limiting. Further, the systems and functions described below can be implemented in many different embodiments of hardware. Any actual hardware described is not meant to be limiting. The operation and behavior of the systems and methods presented are described with the understanding that modifications and variations of the embodiments are possible given the level of detail presented. 
     In an embodiment shown schematically in  FIGS. 3-4 , handle  140  may include a housing  142  and an actuator mechanism  144 . More particularly, handle  140  includes a cavity  143  ( FIG. 4 ) defined by housing  142  and configured to receive portions of actuator mechanism  144 . In an embodiment shown in  FIGS. 2-4 , housing  140  may include a longitudinal slot  146  through which actuator mechanism  144  extends for interfacing by a user. Handle  140  provides a surface for convenient handling and grasping by a user, and may have a generally cylindrical shape as shown. While handle  140  of  FIGS. 2-4  is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes are contemplated based on the application requirements. Actuator mechanism  144  is generally constructed to provide selective retraction/advancement of outer shaft assembly  110 . Although shown as a slide mechanism, other constructions and/or devices may be used to retract/advance outer shaft assembly  110 , such as, but to limited to rotating mechanisms, sliding mechanisms that are coaxially disposed over inner shaft assembly  104 , combinations of rotating and sliding mechanisms, and other advancement/retraction mechanisms known to those skilled in the art. 
     Outer shaft assembly  110  is slidably disposed over inner shaft assembly  104 . With reference to  FIGS. 3-4 , in an embodiment, outer shaft assembly  110  includes a proximal shaft  118  and a capsule  107 , and defines a lumen  112  extending from a proximal end  130  of proximal shaft  118  to a distal end  132  of capsule  107 . Although outer shaft  110  is described herein as including capsule  107  and proximal shaft  118 , capsule  107  may simply be an extension of proximal shaft  118 . Further, outer shaft  110  may be referred to as a sheath or outer sheath. Proximal shaft  118  is configured for fixed connection to capsule  107  at a connection point  116  at a proximal end  109  of capsule  107  by fusing, welding, adhesive, sutures, or other means suitable for the purposes described herein. Alternatively, proximal shaft  118  and capsule  107  may be unitary. Proximal shaft  118  extends proximally from capsule  107  and proximal shaft  118  is configured for connection to handle  140 . More particularly, proximal shaft  118  extends proximally into housing  142  of handle  140  and a proximal portion  131  of proximal shaft  118  is connected to actuator mechanism  144  of handle  140 . Proximal portion  131  is coupled to actuator mechanism  144  such that movement of actuator mechanism  144  causes outer shaft assembly  110  to move relative inner shaft assembly  104 . Proximal shaft  118  may be coupled to actuator mechanism  144 , for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. Outer shaft assembly  110  is thus movable relative to handle  140  and inner shaft assembly  104  by actuator mechanism  144 . However, if actuator mechanism  144  is not moved and handle  140  is moved, outer shaft assembly  110  moves with handle  140 , not relative to handle  140 . 
     Inner shaft assembly  104  extends within lumen  112  of outer shaft assembly  110 , as shown at least in  FIG. 4 . Inner shaft assembly  104  includes an inner shaft  114 , a distal tip  122 , and balloon  150 , described in greater detail below. Inner shaft  114  extends from a proximal end  134  of inner shaft  114  to a distal end  136 . Distal end  136  of inner shaft  114  is attached to distal tip  122 . The components of inner shaft assembly  104  combine to define a guidewire lumen  123 , which is sized to receive an auxiliary component such as a guidewire (not shown) and an inflation lumen  192 , described in greater detail below. In the embodiments shown, delivery device  100  includes an over-the-wire (OTW), multi-lumen configuration with guidewire lumen  123  extending substantially the entire length of inner shaft assembly  104 . However, other configurations, such as rapid exchange configurations, may also be used. Proximal end  134  of inner shaft  114  may be attached to handle  140  or may be attached to another device such as a hub. Inner shaft  114  may be coupled to handle  140 , for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. During sliding or longitudinal movement of outer shaft assembly  110  relative to inner shaft assembly  104 , inner shaft  114  may be fixed relative to handle  140 . 
     As previously noted, inner shaft assembly  114  includes an inflation lumen  192  and a guidewire lumen  123  extending therethrough.  FIG. 5  shows a cross-sectional view of inner shaft  114  disposed within outer shaft assembly  110 . As shown in  FIG. 5 , guidewire lumen  123  and inflation lumen  192  extend through inner shaft  114 . In the embodiment shown, inflation lumen  192  and guidewire lumen  123  are two lumens extending through a single shaft. However, other constructions may also be used. 
       FIGS. 6A and 6B  show a distal portion of delivery device  100  with heart valve prosthesis  10  disposed therein in a delivery configuration. Heart valve prosthesis  10  is disposed within capsule  107  of outer shaft assembly  110  and over inner shaft  114 . Balloon  150  is disposed proximal of heart valve prosthesis  10  and is coupled to inner shaft  114 . In the delivery configuration shown in  FIG. 6A , balloon  150  is disposed within outer shaft assembly  110 . In the embodiment shown in  FIGS. 6A and 6B , proximal end  154  of balloon  150  is attached to inner shaft  114  at a proximal bond  155 . Similarly, distal end  156  of balloon  150  is attached to inner shaft  114  at a distal bond (not shown). Inner shaft  114  continues distally beyond the distal bond of balloon  150 /inner shaft  114 . Inflation lumen  192  includes an inflation port  196  that opens into an interior  151  of balloon  150 . 
     Distal end  156  of balloon  150  may also be described as a shaped end  152 . Shaped end  152  is shaped to engage first end  34  of frame  14  of heart valve prosthesis  10 . In an embodiment, shaped end  152  includes a plurality of peaks  158  extending distally and valleys  160  extending proximally. Peaks  158  and valleys  160  are spaced radially from the central longitudinal axis LA c . Peaks  158  and valleys  160  may be arranged opposite of peaks  18  and valleys  20  of first end  34  of frame  14 ; in particular, the radially outer portion of inflow rim  15  of  FIG. 1 . Balloon  150  is in an uninflated configuration and disposed within outer shaft assembly  110  for delivery, as shown in  FIG. 6A , and is inflated to an inflated configuration to engage and rotate frame  14 , as shown in  FIG. 6B . Balloon  150  may be a compliant high friction balloon constructed of any suitable material, such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. Moreover, balloon  150  may include a three-dimensional pattern, or texture, on an outer surface to increase engagement (frictional contact) with the heart valve prosthesis  10  when the balloon is in the second (inflated) configuration. 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 6A , heart valve prosthesis  10  is disposed in a radially compressed configuration within capsule  107  of outer shaft assembly  110 . Balloon  150  is also uninflated. Delivery device  100  is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  110  is retracted proximally, thereby retracting capsule  107  proximally. Capsule  107  is retracted proximally sufficiently to expose heart valve prosthesis  10 . In the embodiment shown, heart valve prosthesis  10  is self-expanding. Therefore, retraction of capsule  107  enables heart valve prosthesis  10  to self-expand to the radially expanded configuration. Capsule  107  may be retracted further proximally, or may have been retracted further initially, such that balloon  150  is not covered by capsule  107 . An inflation fluid, such as but not limited to saline, is injected through inflation lumen  192 , out of inflation port  196 , and into the interior  151  of balloon  150 , thereby inflating balloon  150 , as shown in  FIG. 6B . Delivery device  100  may be rotated to align shaped end  152  of balloon  150  with the shaped first end  34  of frame  14  of heart valve prosthesis  10 , if necessary. Delivery device  100  may also be advanced longitudinally, if necessary, such that shaped end  152  of balloon  150  engages the shaped end first end  34  of frame  14  of heart valve prosthesis  10 , as shown in  FIG. 6B . In an engagement embodiment, peaks  158  of balloon  150  engage corresponding valleys  20  of heart valve prosthesis  10 , and valleys  160  of balloon  150  engage corresponding peaks  18  of heart valve prosthesis  10 . 
     With shaped end  152  of balloon  150  engaged with shaped first end  24  of frame  14  of heart valve prosthesis  10 , delivery device  100  may be rotated in a direction R r  relative to central longitudinal axis LA c , thereby rotating shaped end  152  of balloon  150  in direction R r  such that shaped end  152  applies a rotational torque in direction R r  to engaged corresponding shaped first end  34  of frame  14 . This rotational torque rotates heart valve prosthesis  10  in direction R r  such that torque anchoring mechanisms  22  are embedded in tissue at the desired implantation site. Stated another way, with balloon  150  inflated, heart valve prosthesis  10  in the radially expanded configuration, and shaped end  152  of balloon  150  engaged with shaped first end  26  of heart valve prosthesis  10 , delivery device  100  is rotated in direction R r  to embed torque anchoring mechanisms  22  in tissue, thereby anchoring heart valve prosthesis  10  to tissue at the desired implantation site. Balloon  150  may then be deflated and delivery device  100  may be withdrawn from the patient, leaving heart valve prosthesis  10  implanted at the desired implantation site. 
       FIGS. 6A-6B  shows a particular embodiment of balloon  150  and heart valve prosthesis  10 . As explained above, this particular embodiment is not meant to limit the design. Therefore, for example and not by way of limitation, shaped end  152  of balloon  150  may be at proximal end  154  instead of distal end  156 , and heart valve prosthesis  10  would be disposed proximal of balloon  150  such that proximal end  154  of balloon  150  could engage a shaped distal end of heart valve prosthesis  10 . Further, the specific number of peaks  158  and valleys  160  of balloon  150  shown in  FIGS. 6A and 6B  is merely an example, and may be increased or decreased to match a corresponding number of peaks and valleys in the shaped end of heart valve prosthesis  10 . 
       FIGS. 7A-7B  illustrate a distal portion of another embodiment of a delivery device  100 ′ for delivering and deploying a heart valve prosthesis  10 . Delivery device  100 ′ is similar to the embodiment of  FIGS. 6A-6B , so only the differences between the embodiments will be described in detail here. Features not specifically described may be like those described with respect to the embodiment of  FIGS. 6A-6B , or other embodiments described herein. In the embodiment of  FIGS. 7A-7B , instead of an inner shaft with a guidewire lumen  123  and an inflation lumen  192 , as described above, inner shaft assembly  104 ′ includes a guidewire shaft  114 ′ with an inflation shaft  190  disposed coaxially over guidewire shaft  114 ′. A guidewire lumen  123 ′ extends through guidewire shaft  114 ′ and an inflation lumen  192 ′ is defined between an outer surface of guidewire shaft  114 ′ and an inner surface of inflation shaft  190 . 
     In the embodiment shown in  FIGS. 7A-7B , proximal end  154  of balloon  150  is attached to inflation shaft  190  at a proximal bond  155 ′. Inflation shaft  190  terminates prior to distal end  156  of balloon  150  such that an inflation port  196 ′ is formed between a distal end  194  of inflation shaft and guidewire shaft  114 ′. Distal end  156  of balloon  150  is attached to guidewire shaft  114 ′ at a distal bond (not shown). When an inflation fluid is injection into inflation lumen  192 ′, the inflation fluid exits inflation lumen  192 ′ through inflation port  196 ′ and into the interior  151  of balloon  150 , thereby inflating balloon  150 , as shown in  FIG. 7B . 
       FIGS. 8A-8B  illustrate a distal portion of another embodiment of a delivery device  100 ″. Delivery device  100 ″ includes a first balloon  150  and a second balloon  162 .  FIG. 8A  shows delivery device  100 ″ with heart valve prosthesis  10  including torque anchoring mechanisms  22  disposed therein.  FIG. 8A  shows delivery device  100 ″ in a delivery configuration with first balloon  150 , second balloon  162 , and heart valve prosthesis  10  disposed within outer shaft assembly  110  such that first balloon  150  and second balloon  162  are uninflated, and heart valve prosthesis  10  is in a radially compressed configuration. 
     Delivery device  100 ″ is similar to delivery device  100  except for the addition of second balloon  162  and extension of inflation lumen  192 ″ distally to second balloon  162 . Therefore, except for the differences specifically noted below, elements of delivery device  100 ″ may be the same as or similar to the corresponding elements of  FIGS. 2-6B . In particular, the proximal portion of delivery device  100 ″ is not described in detail and may be similar to the proximal portion of delivery device  100  described above with respect to  FIGS. 2-4 . 
     As shown in  FIGS. 8A-8B , second balloon  162  includes a proximal end  164  attached to inner shaft inner shaft  114  at a proximal bond  163  and a distal end  166  attached to inner shaft  114  at a distal bond  165 . Second balloon  162  is disposed distal of heart valve prosthesis such that proximal end  164  of second balloon is adjacent second end  32  of heart valve prosthesis  10 . First balloon  150  is disposed proximal of heart valve prosthesis  10  and is coupled to inner shaft  114 . In the delivery configuration shown in  FIG. 8A , balloon  150  is disposed within outer shaft assembly  110 . In the embodiment shown in  FIGS. 8A-8B , proximal end  154  of first balloon  150  is attached to inner shaft  114  at a proximal bond  155  and distal end  156  of balloon  150  is attached to inner shaft  114  at a distal bond  157 . Inner shaft  114  continues distally beyond distal bond  155 . 
     Inflation lumen  192 ″ of inner shaft  114  is extended distally to a second inflation port  208  which opens to an interior of second balloon  162 . Second inflation port  208  is disposed between proximal end  164  and distal end  166  of second balloon  162  such that inflation fluid injected through inflation lumen  192 ″ exits second inflation portion  208  into an interior of second balloon  162 , thereby inflating second balloon  162 . As in the embodiment of  FIGS. 6A-6B , inflation fluid injected into inflation lumen  192 ″ exits inflation portion  196 ″ into an interior  151  of first balloon  150 , thereby inflating first balloon  150 . 
     As in the embodiment of  FIGS. 6A-6B , distal end  154  of balloon  150  is a shaped end  152  shaped to engage first end  34  of frame  14  of heart valve prosthesis  10 . In an embodiment, shaped end  152  includes a plurality of peaks  158  extending distally and valleys  160  extending proximally. Peaks  158  and valleys  160  are spaced radially from the central longitudinal axis LAc. Peaks  158  and valleys  160  are arranged opposite of peaks  18  and valleys  20  of first end  34  of frame  14 . First balloon  150  is in an uninflated configuration and disposed within outer shaft assembly  110  for delivery, as shown in  FIG. 8A , and is inflated to an inflated configuration to engage and rotate frame  14 , as shown in  FIG. 8B . First balloon  150  may be a compliant high friction balloon constructed of any suitable material, such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 8A , heart valve prosthesis  10  is disposed in a radially compressed configuration within capsule  107  of outer shaft assembly  110 . First balloon  150  and second balloon  162  are uninflated. Delivery device  100 ″ is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  110  is retracted proximally, thereby retracting capsule  107  proximally. Capsule  107  is retracted proximally sufficiently to expose heart valve prosthesis  10 . In the embodiment shown, heart valve prosthesis  10  is self-expanding. Therefore, retraction of capsule  107  enables heart valve prosthesis  10  to self-expand to the radially expanded configuration. Capsule  107  may be retracted further proximally, or may have been retracted further initially, such that first balloon  150  is not covered by capsule  107 . An inflation fluid, such as but not limited to saline, is injected through inflation lumen  192 ″, out of inflation ports  196 ″ and  206 , and into the interior  151  of first balloon  150  and the interior of second balloon  162 , thereby inflating first balloon  150  and second balloon  162 , as shown in  FIG. 8B . Delivery device  100 ″ may be rotated to align shaped end  152  of first balloon  150  with the shaped first end  34  of frame  14  of heart valve prosthesis  10 , if necessary. Delivery device  100  may also be advanced longitudinally, if necessary, such that shaped end  152  of first balloon  150  engages the shaped first end  34  of frame  14  of heart valve prosthesis  10 , as shown in  FIG. 8B . In an engagement embodiment, peaks  158  of first balloon  150  engage corresponding valleys  20  of heart valve prosthesis  10 , and valleys  160  of first balloon  150  engage corresponding peaks  18  of heart valve prosthesis  10 . In particular, shaped end  152  of first balloon  150  engages the peaks and valleys of the radially outward, bent portion of inflow rim  15  of heart valve prosthesis  10   
     When second balloon  162  is inflated, proximal end  164  may engage distal end  32  of heart valve prosthesis  10  when heart valve prosthesis  10  is in the radially expanded configuration, as shown in  FIG. 8B . Second balloon  162  is configured to provide longitudinal stability for heart valve prosthesis  10  along central longitudinal axis LA c  relative to delivery device  100 ″ as heart valve prosthesis  10  is rotated and torque anchoring mechanisms  22  are embedded in tissue at desired implantation site. Second balloon  162  may be a compliant high friction balloon constructed of any suitable material, such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. 
     With shaped end  152  of first balloon  150  engaged with shaped first end  24  of frame  14  of heart valve prosthesis  10  and second balloon  162  abutting second end  36  of frame  14 , delivery device  100 ″ may be rotated in a direction R r  relative to central longitudinal axis LA S , thereby rotating shaped end  152  of first balloon  150  in direction R r  such that shaped end  152  applies a rotational torque in direction R r  to engaged corresponding shaped first end  34  of frame  14 . This rotational torque rotates heart valve prosthesis  10  in direction R r  such that torque anchoring mechanisms  22  are embedded in tissue at the desired implantation site. Stated another way, with first balloon  150  and second balloon  162  inflated, heart valve prosthesis  10  in the radially expanded configuration, and shaped end  152  of balloon  150  engaged with shaped first end  26  of heart valve prosthesis  10 , delivery device  100 ″ is rotated in direction R r  to embed torque anchoring mechanisms  22  in tissue, thereby anchoring heart valve prosthesis  10  to tissue at the desired implantation site. First and second balloons  150 ,  162  may then be deflated and delivery device  100 ″ may be withdrawn from the patient, leaving heart valve prosthesis  10  implanted at the desired implantation site. 
       FIGS. 8A-8B  show the inflation lumen  192 ″ and guidewire lumen  123  extending through the inner shaft  114 , similar to the embodiment of  FIGS. 6A-6B . However, instead of a single inflation lumen  192 ″, there may be two inflation lumens; one for first balloon  150  and another for second balloon  162 . Additionally, instead of multiple lumens through an inner shaft, multiple coaxial shafts with annular lumen(s) may be used, similar the embodiment of  FIGS. 7A-7B . In such an embodiment, a single inflation shaft may be used with an inflation lumen between the guidewire shaft and the inflation shaft. The inflation shaft extends to the second balloon with an inflation port through the inflation shaft at the first balloon and an inflation port opening at the second balloon. Alternatively, two annular inflation shafts may be used, one terminating at the first balloon and the second terminating at the second balloon. Other arrangements of guidewire lumens and inflation lumens may be utilized as would be understood to those skilled in the art. 
       FIGS. 9A-9B  illustrate a distal portion of another embodiment of a delivery device  100 ′″. Delivery device  100 ′″ includes a dumbbell-shaped balloon  170 .  FIG. 9A  shows delivery device  100 ′″ with heart valve prosthesis  10  including torque anchoring mechanisms  22  disposed therein.  FIG. 9A  shows delivery device  100 ′″ in a delivery configuration with dumbbell-shaped balloon  170  and heart valve prosthesis disposed within outer shaft assembly  110  with dumbbell-shaped balloon  170  uninflated and heart valve prosthesis  10  in a radially compressed configuration. 
     Delivery device  100 ′″ is similar to delivery device  100  of  FIGS. 2-6B  except that dumbbell-shaped balloon  170  replaces balloon  150  and inflation lumen  210  of  FIGS. 9A-9B  is different from inflation lumen  192  of  FIGS. 2-6B . Therefore, except for the differences specifically noted below, elements of delivery device  100 ′″ are the same as or similar to the corresponding elements of  FIGS. 2-6B . In particular, the proximal portion of delivery device  100 ′″ is not described in detail and may be similar to the proximal portion of delivery device  100  described above with respect to  FIGS. 2-4 . 
     As shown in  FIG. 9B , dumbbell-shaped balloon  170  includes first portion  172 , a second portion  180 , and a third portion  186  disposed between first portion  172  and second portion  180 . A proximal end  176  of first portion  172  is attached to inner shaft  114  at a proximal bond  175  and a distal end  184  of second portion  180  is attached to inner shaft  114  at a distal bond  185 , as shown in  FIG. 9A . First portion  172  of balloon  170  is disposed proximal of heart valve prosthesis  10  and second portion  180  is disposed distal of heart valve prosthesis  10 . Third portion  186  of dumbbell-shaped balloon  170  is disposed under heart valve prosthesis  10 . In other words, heart valve prosthesis  10  is disposed on third (middle) portion  186  of dumbbell-shaped balloon  170 . In the delivery configuration shown in  FIG. 9A , dumbbell-shaped balloon  170  is disposed within outer shaft assembly  110 . In the embodiment of  FIGS. 9A-9B , dumbbell-shaped balloon  170  is a single balloon shaped to form the portions noted above and described in more detail below. However, dumbbell-shaped balloon  170  may instead be three separate balloons. Alternatively, dumbbell-shaped balloon  170  may be a single balloon and the three portions noted above may be separate compartments of the balloon. 
     Inner shaft assembly  104  of  FIGS. 9A-9B  is similar to inner shaft assembly  104  of  FIGS. 6A-6B , including an inner shaft  114  having a guidewire lumen  123  and an inflation lumen  210  extending therethrough. Inflation lumen  210  is in fluid communication with dumbbell-shaped balloon  170 . In the embodiment shown in  FIGS. 9A-9B , inflation lumen includes a first inflation portion  216  in fluid communication with first portion  172 , a second inflation port  218  in fluid communication with second portion  180 , and a third inflation portion  220  in fluid communication with opening third portion  186 . However, if dumbbell-shaped balloon  170  is a single balloon with a single interior, as explained above, an inflation portion for each portion is not necessary. If each portion of dumbbell-shaped balloon  170  is a separate balloon or the portions are separate compartments, at least three inflation ports are needed, one for each balloon/compartment. 
     As shown in  FIG. 9B , a distal end  178  of first portion  172  of dumbbell-shaped balloon  170  is a shaped end  174  shaped to engage first end  34  of frame  14  of heart valve prosthesis  10 . In an embodiment, shaped end  174  includes a plurality of peaks  175  extending distally and a plurality of valleys  177  extending proximally. Peaks  175  and valleys  177  are spaced radially from the central longitudinal axis LAc. Peaks  175  and valleys  177  are arranged opposite of peaks  18  and valleys  20  of first end  34  of frame  14 . Dumbbell-shaped balloon  170  is in an uninflated configuration and disposed within outer shaft assembly  110  for delivery, as shown in  FIG. 9A , and is inflated to an inflated configuration to engage and rotate frame  14 , as shown in  FIG. 9B . Dumbbell-shaped balloon  170  may be a compliant high friction balloon constructed of any suitable material, such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. 
       FIG. 9B  shows dumbbell-shaped balloon  170  in the inflated configuration. First portion  172  of dumbbell shaped balloon  170  has a first expanded diameter D f  in the inflated configuration. Second portion  180  of dumbbell-shaped balloon  170  has a second expanded diameter D s  in the inflated configuration. A proximal end  182  of second portion  180  is configured such that proximal end  182  abuts second end  32  of heart valve prosthesis  10 . Second portion  180  is configured to provide longitudinal stability for heart valve prosthesis  10  along central longitudinal axis LA c  relative to delivery device  100 ′″ as heart valve prosthesis  10  is rotated and torque anchoring mechanisms  22  are embedded in tissue at desired implantation site. Stated another way, when second portion  180  of dumbbell-shaped balloon  170  is in the inflated configuration, second portion  180  is configured to prevent shaped end  26  of heart valve prosthesis  10  from disengaging from shaped end  174  of first portion  172  of dumbbell-shaped balloon  170 . Third portion  186  of dumbbell-shaped balloon  170  has a third expanded diameter D t  when in the inflated configuration. Third portion  186  is configured such that when third portion  186  is in the inflated configuration, an outer surface  189  of third portion  186  engages an inner surface of heart valve prosthesis  10 . Stated another way, when third portion  186  of dumbbell-shaped balloon  170  is in the inflated configuration, third portion  186  provides radial force outward from central longitudinal axis LA c , supporting frame  14  of heart valve prosthesis  10 . When first, second, and third portions  172 ,  180 , and  186  are each in the inflated configuration, third expanded diameter D t  is smaller than both first expanded diameter D f  and second expanded diameter D s . 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 9A , heart valve prosthesis  10  is disposed in a radially compressed configuration within capsule  107  of outer shaft assembly  110 . Dumbbell shaped balloon  170  is uninflated. In other embodiments, and particularly with third portion  186  of dumbbell-shaped balloon  170  engaging an inner surface of heart valve prosthesis  10 , capsule  107  may be excluded. In particular, heart valve prosthesis  10  may be balloon-expandable. Delivery device  100 ′″ is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  110  is retracted proximally, thereby retracting capsule  107  proximally. Capsule  107  is retracted proximally sufficient to expose heart valve prosthesis  10 . In the embodiment shown, heart valve prosthesis  10  is self-expanding. Therefore, retraction of capsule  107  enables heart valve prosthesis  10  to self-expand to the radially expanded configuration. Capsule  107  may be retracted further proximally, or may have been retracted further initially, such that first portion  172  of dumbbell shaped balloon  170  is not covered by capsule  107 . An inflation fluid, such as but not limited to saline, is injected through inflation lumen  210 , out of inflation ports  216 ,  218 , and  220 , and into the interiors of first, second, and third portions  172 ,  180 , and  186  of dumbbell-shaped balloon  170 , thereby inflating dumbbell-shaped balloon  170 , as shown in  FIG. 9B . In other embodiments, heart valve prosthesis  10  may be balloon-expandable and capsule  107  may be eliminated. When such a delivery device is at the implantation site, dumbbell-shaped balloon  170  is inflated, thereby expanding heart valve prosthesis  10 . Shaped end  174  of first portion  172  of dumbbell-shaped balloon  170  is aligned with the shaped first end  34  of frame  14  of heart valve prosthesis  10 . In an embodiment, peaks  175  of first portion  172  of dumbbell-shaped balloon  170  engage corresponding valleys  20  of heart valve prosthesis  10 , and valleys  177  of dumbbell-shaped balloon  170  engage corresponding peaks  18  of heart valve prosthesis  10 . Also, proximal end  182  of second portion  180  of dumbbell-shaped balloon  170  abuts second end  34  of heart valve prosthesis  10 . In an embodiment, heart valve prosthesis  10  may be compressively held between first portion  172  and third portion  186  of balloon  170  when balloon  170  is in the second (inflated) configuration. 
     With shaped end  174  of first portion  172  of dumbbell shaped balloon  170  engaged with shaped first end  24  of frame  14  of heart valve prosthesis  10  and second portion  180  of dumbbell shaped balloon  170  abutting second end  36  of frame  14 , delivery device  100 ′″ may be rotated in a direction R r  relative to central longitudinal axis LA c , thereby rotating dumbbell-shaped balloon  170  in direction R r  such that shaped end  174  applies a rotational torque in direction R r  to engaged corresponding shaped first end  34  of frame  14 . This rotational torque rotates heart valve prosthesis  10  in direction R r  such that torque anchoring mechanisms  22  are embedded in tissue at the desired implantation site. Stated another way, with dumbbell shaped balloon  170  inflated, heart valve prosthesis  10  in the radially expanded configuration, and shaped end  174  of first portion  172  of dumbbell shaped balloon  170  engaged with shaped first end  26  of heart valve prosthesis  10 , delivery device  100 ′″ is rotated in direction R r  to embed torque anchoring mechanisms  22  in tissue, thereby anchoring heart valve prosthesis  10  to tissue at the desired implantation site. Dumbbell-shaped balloon  170  may then be deflated and delivery device  100 ′″ may be withdrawn from the patient, leaving heart valve prosthesis  10  implanted at the desired implantation site. 
       FIGS. 10A-10C  illustrate a distal portion of another embodiment of a delivery device  100 ′″. Delivery device  100 ′″ includes a balloon  250 .  FIG. 10A  shows delivery device  100 ′″ with heart valve prosthesis  10  including torque anchoring mechanisms  22  ( FIG. 10B ) disposed therein.  FIG. 10A  shows delivery device  100 ′″ in a delivery configuration with balloon  250  and heart valve prosthesis  10  disposed within outer shaft assembly  110 . Balloon  250  is uninflated and heart valve prosthesis  10  is in a radially compressed configuration. 
     Delivery device  100 ′″ is similar to delivery device  100  of  FIGS. 2-6B  except that balloon  250  replaces balloon  150  and is disposed within heart valve prosthesis  10 . Therefore, except for the differences specifically noted below, elements of delivery device  100 ″″ are the same as or similar to the corresponding elements of  FIGS. 2-6B . In particular, the proximal portion of delivery device  100 ″″ is not described in detail and may be similar to the proximal portion of delivery device  100  described above with respect to  FIGS. 2-4 . 
     As shown in  FIG. 10A , a proximal end  254  of balloon  250  is attached to inner shaft  114  at a proximal bond  255  and a distal end  256  is attached to inner shaft  114  at a distal bond  257 . Balloon  250  is disposed under (within) heart valve prosthesis  10 . In other words, heart valve prosthesis  10  is disposed on balloon  250 . In the delivery configuration shown in  FIG. 10A , balloon  250  is thus disposed within outer shaft assembly  110 . 
     Inner shaft assembly  104  of  FIGS. 10A-10B  is similar to inner shaft assembly  104  of  FIGS. 6A-6B , including an inner shaft  114  having a guidewire lumen  123  and an inflation lumen  192  extending therethrough. Inflation lumen  192  is in fluid communication with balloon  250 . In the embodiment shown in  FIGS. 10A-10B , inflation lumen  192  includes an inflation port  196  in fluid communication with balloon  250 . 
     As shown in  FIG. 10B  and in greater detail in  FIG. 100 , an outer surface  253  of balloon  250  includes a shaped portion  252 . In an embodiment, shaped portion  252  is configured to extend into open spaces  17  and engage frame  14  of heart valve prosthesis  10  when balloon  250  is inflated. In an embodiment, shaped portion  252  includes a plurality of protrusions  258  extending radially outward from the outer surface  253  of balloon  250 . Heart valve prosthesis  10  is loaded onto balloon  250  such that protrusions  258  are arranged opposite of corresponding open spaces  17  of frame  14 . Balloon  250  is in an uninflated configuration and disposed within outer shaft assembly  110  for delivery, as shown in  FIG. 10A , and is inflated to an inflated configuration such that each protrusion  258  extends radially through corresponding open space  17 . When in the inflated configuration, an outer surface of each protrusion  258  engages adjacent struts  16  such that rotation of balloon  250  engages and rotates frame  14 , as shown in  FIG. 10B . Balloon  250  may be a compliant high friction balloon constructed of any suitable material, such as, but not limited to, polyethylene terephthalate (PET), nylon, or polyurethane. 
       FIG. 10B  shows balloon  250  in the inflated configuration. Balloon  250  is further configured such that when balloon  250  is in the inflated configuration, the outer surface  253  of balloon  250  engages an inner surface of heart valve prosthesis. Thus, when balloon  250  is in the inflated configuration, balloon  250  provides radial force outward from central longitudinal axis LA c , supporting frame  14  of heart valve prosthesis  10  and is configured to engage and rotate frame  14 . 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 10A , heart valve prosthesis  10  is disposed in the radially compressed configuration within capsule  107  of outer shaft assembly  110 . Balloon  250  is in the uninflated configuration and is disposed within heart valve prosthesis  10 . In other embodiments, as explained above, capsule  107  may be excluded. Delivery device  100 ′″ is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  110  is retracted proximally, thereby retracting capsule  107  proximally. Capsule  107  is retracted proximally sufficient to expose heart valve prosthesis  10  and balloon  250  therein. In the embodiment shown, heart valve prosthesis  10  is self-expanding. Therefore, retraction of capsule  107  enables heart valve prosthesis  10  to self-expand to the radially expanded configuration. An inflation fluid, such as but not limited to saline, is injected through inflation lumen  192 , out of inflation port  196  and into the interior of balloon  250 , thereby inflating balloon  250  (transitioning from the uninflated to the inflated configuration), as shown in  FIG. 10B . In other embodiments, heart valve prosthesis  10  may be balloon-expandable and capsule  107  may be eliminated. When such a delivery device is at the implantation site, balloon  250  is inflated, thereby expanding heart valve prosthesis  10 . Protrusions  258  of shaped portion  252  of balloon  250  are aligned with open spaces  17  between adjacent struts  16  of frame  14  of heart valve prosthesis  10 . 
     With shaped portion  252  of balloon  250  engaged with open spaces  17  and struts  16  of frame  14  of heart valve prosthesis  10 , delivery device  100 ″″ may be rotated in a direction R r  relative to central longitudinal axis LA c , thereby rotating balloon  250  in direction R r  such that shaped portion  252  applies a rotational torque in direction R r  to engaged corresponding frame  14 . This rotational torque rotates heart valve prosthesis  10  in direction R r  such that torque anchoring mechanisms  22  are embedded in tissue at the desired implantation site. Stated another way, with balloon  250  inflated, heart valve prosthesis  10  in the radially expanded configuration, and shaped portion  252  of balloon  250  engaged with frame  14  of heart valve prosthesis  10 , delivery device  100 ″″ is rotated in direction R r  to embed torque anchoring mechanisms  22  in tissue, thereby anchoring heart valve prosthesis  10  to tissue at the desired implantation site. Balloon  250  may then be deflated and delivery device  100 ″″ may be withdrawn from the patient, leaving heart valve prosthesis  10  implanted at the desired implantation site. 
     Features of any of the embodiments described above may be used with any of the other embodiments described above. Further, variations in the number of balloons, inflation lumens, inflation ports, and similar items may be made within the scope of the invention. For example, and not by way of limitation, the delivery devices described above and below may also include an outer stability shaft disposed outside of the outer shaft assembly  110 . Other details of the delivery devices may be as described in U.S. Pat. No. 8,414,645 to Dwork; U.S. Pat. No. 8,876,893 to Dwork; U.S. Pat. No. 8,926,692 to Dwork, each of which is incorporated in its entirety herein. Other materials than those described above may also be used within the scope of the invention. 
       FIGS. 11A-11D and 12A-12B  illustrate another embodiment of a heart valve prosthesis  500  including a toque anchoring mechanism  530 . Heart valve prosthesis  500  includes a frame  502  and a prosthetic heart valve  504  (see  FIGS. 11C-11D ) coupled to the frame  502 . Prosthetic heart valve  504  may be any suitable prosthetic heart valve known to those skilled in the art, and may be bi-leaflet, tri-leaflet (shown) or any other suitable design. Frame  502  may include an inflow rim  510  and an outflow tube  520 . Inflow rim  510  and outflow tube  520  need not be separate parts and generally may be a unitary with inflow rim  510  flaring radially outwardly from outflow tube  520 . Frame  502 , including inflow rim  510  and outflow tube  520  may be formed by a plurality of struts  512  with spaces or openings  513  formed there between, as known to those skilled in the art. Frame  502  is radially compressible for delivery and radially expandable for deployment at the treatment site.  FIGS. 11A-11D and 12A-12B  show frame  502  in a radially expanded configuration. Frame  502  may be self-expanding or balloon expandable. Frame  502  may be formed from materials such as, but not limited to, nickel titanium alloys (e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high spring temper steel, or any other metal or other material suitable for purposes of the present disclosure. 
     Frame  502  defines a first or inflow end  506  and a second or outflow end  508  of heart valve prosthesis  500 . Frame  502  is generally tubular and defines a central passage  524  therethrough. Prosthetic valve  504  is disposed in the central passage  504 , as shown in  FIGS. 11C and 11D . 
     Torque anchoring mechanism  530  of heart valve prosthesis  500  includes a ring  532  with a plurality of barbs  534  extending radially outwardly from the ring  532 , as shown in  FIGS. 11A-11D and 12A-12B . In the embodiment shown, ring  532  is disposed over (around) outflow tube  520  such that an inner surface of ring  532  circumscribes an outer surface of outflow tube  520 . Ring  532  is rotatable relative to outflow tube  520  and inflow ring  510 , as will be described in greater detail below. Ring  532  is also radially compressible and expandable such that ring  532  may be radially compressed for transluminal delivery and radially expandable at the treatment site for deployment. Ring  532  may be self-expanding or balloon expandable. 
     Each barb  534  includes distal tip  536  at an end opposite from ring  532 . Distal tip  536  may be a sharp tip to assist in engagement with tissue. Each barb  534  may be formed separately from ring  532  and attached thereto, or may be formed unitarily with ring  532 . Barbs  534  are shown extending directly radially outwardly from ring  532  in  FIGS. 11A-11D and 12A . However, in the embodiment shown, barbs  534  are angled, as shown in  FIG. 12B . In particular, each barb  534  includes a first portion  535  extending directly radially outward from ring  532 , a bend  533 , and a second portion  537  extending at an angle α with respect to the radial direction Rd extending through the first portion of the same barb  534 , as shown in  FIG. 12B . Angle α may be 10-90 degrees. In the embodiment shown, barbs  534  are pre-set to the bent shape shown in  FIG. 12B  and are held in the radially outward direction shown in  FIGS. 11A-110 and 12A  by an outside force, described below. Thus, upon removal of the outside force, barbs  534  return to the pre-set bent shape shown in  FIG. 12B . Although  FIG. 12B  shows a particular shape for barbs  534 , it is not limiting. Other shapes, angles, and bends may be used in keeping with the present disclosure. In order for barbs  534  to have a pre-set bend, they may be formed of a shape memory material, including, but not limited to, nickel-titanium alloys (e.g. Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high spring temper steel, or any other metal or other material suitable for purposes of the present disclosure. 
     As shown in  FIGS. 11A-11D and 12A , barbs  534  may be restrained in a straight, directly radially outward direction for delivery and pre-deployment. In particular, as shown in  FIG. 11B , certain struts  512  of inflow portion  510  may each include lips  514  that restrain a barb  534  in the radially outward configuration. Lips  514  may be constructed as an extension of the respective strut  512  of the inflow portion. Lips  514  may extend in a direction generally parallel to the longitudinal axis LA of the heart valve prosthesis  500 , which is generally perpendicular to the longitudinal axis of the respective barb  534  when in the restrained, generally radially outward direction. Lips  514  may instead be constructed as a groove in the respective strut  512  such that barb  534  at least partially sits in the groove, thereby restraining barb  534  from returning to its pre-set bent configuration. Lips  514  also prevent ring  532  from rotating around central longitudinal axis LA until a force is applied to overcome the restraining force of lips  514 , thereby rotating ring  532  and enabling barbs  534  to return to their pre-set bent configuration, as explained in more detail below. 
     Ring  532  may also be restrained from moving longitudinally along outflow portion  520 . Ring  532  may be restrained by lips, grooves, or any other way to prevent ring  532  from sliding longitudinally along outflow portion  520  while still enabling ring  532  to rotate about central longitudinal axis LA. In one non-limiting embodiment shown in  FIG. 11C , a groove  522  is provided circumferentially around a portion of outflow tube  520 . Ring  532  is disposed in groove  522  such ring  532  is disposed between a shoulder  524  that prevents longitudinal movement towards second (outflow) end  508  and inflow ring  510  that prevents longitudinal movement toward first (inflow) end  506 . In another non-limiting example shown in  FIG. 11D , a lip  526  may extend radially outward from outflow portion  520  distal of ring  532 . Thus, ring  532  is disposed between lip  526  and inflow ring  510  such that lip  526  prevents longitudinal movement of ring  532  in a distal (outflow) direction and inflow portion  510  prevents longitudinal movement of ring  532  in a proximal (inflow) direction. Lip  526  may be a continuous lip disposed around the circumference of outflow portion  520 , or a plurality of lips  526  may be disposed intermittently (i.e., spaced from each other) around the circumference of outflow portion  520 . 
     Torque anchoring mechanism  530  is configured such that a delivery device (an example of which is described below) may interact with torque anchoring mechanism  530  to rotate ring  532  such that barbs  534  may embed in tissue at the desired implantation site. In the embodiment shown in  FIGS. 11A-11D and 12A-12B , ring  532  of torque anchoring mechanism  530  includes a plurality of connection points  538  for a delivery system. In an embodiment, connections points  538  are openings disposed through ring  532  for tethers or rods of a delivery system to connect with, as described in more detail below. In the embodiment shown in  FIGS. 12A-12B , three (3) connection points  538  are shown. However, more or fewer connection points  538  may be utilized provided that the delivery system is configured to rotate ring  532  to overcome the restraining force of lips  514 . 
     With the above of the components of heart valve prosthesis  500  in mind, delivery and deployment of heart valve prosthesis  500  is explained. Heart valve prosthesis  500  is compressed into the radially compressed configuration for delivery. In the radially compressed configuration, outflow tube  520  is radially compressed. Inflow portion  510  and torque anchor mechanism  530  may be rotated such that they extend longitudinally away from outflow portion  520  and may be radially compressed. Heart valve prosthesis  500  is delivered to the treatment site such as a native mitral valve in a delivery device in the radially compressed configuration. When at the treatment site, a capsule or sheath of the delivery device may be retracted, thereby enabling heart valve prosthesis  500  to self-expand to the radially expanded configuration shown in  FIGS. 11A and 12A . As can be seen in  FIGS. 11A and 12A , barbs  534  extend radially outward. The delivery system remains coupled to heart valve prosthesis  500 , such as through tethers described below interacting with connection points  538  of ring  532 . With heart valve prosthesis  500  at the desired location and in the radially expanded configuration, the delivery device or a portion thereof is rotated such that the portion of the delivery device connected to ring  532  is rotated, thereby rotating ring  532 . This rotation overcomes the retraining force of lips  514 . With barbs  534  no longer restrained by lips  514 , barbs  534  revert back to their pre-set bent configuration, as shown in  FIG. 12B . Also, due to rotation of ring  532 , the now angled barbs  534  embed into tissue at the implantation site, thereby anchoring heart valve prosthesis  500  at the implantation site. 
     Although a specific embodiment of heart valve prosthesis  500  has been disclosed, variations may be made in keeping with the present disclosure. For example, and not by way of limitation, barbs  534  need not be straightened by lips  514  and then returned to their pre-set bent configuration. Instead, barbs  534  may be curved or bent prior to rotation of ring  532 . In such an embodiment, lips  514  may be eliminated or may still be used to keep ring  534  from rotating during delivery and initial deployment of heart valve prosthesis  500 . In such an embodiment, when heart valve prosthesis is initially deployed from the delivery system, heart valve prosthesis  500  radially expands as shown in  FIG. 12C . As can be seen, barbs  534  are already curved or bent. However, as described above, each barb  534  may be held in place by lips  514 . Thus, a portion of each barb  534  in  FIG. 12C  is hidden by the corresponding strut  512 . As explained above, the delivery system remains coupled to heart valve prosthesis  500  of  FIG. 12C , such as through tethers described below interacting with connection points  538  of ring  532 . With heart valve prosthesis  500  at the desired location and in the radially expanded configuration, the delivery device or a portion thereof is rotated such that the portion of the delivery device connected to ring  532  is rotated, thereby rotating ring  532 . This rotation overcomes the retraining force of lips  514 . Thus, ring  532  rotates and angled barbs  534  embed into tissue at the implantation site, thereby anchoring heart valve prosthesis  500  at the implantation site. 
     Other variations to heart valve prosthesis  500  may be utilized. For example, and not by way of limitation, clips or arms at second (outflow) end  208  may be utilized for heart valve prosthesis  500  to engage native leaflets of the native valve. Further, elements of the other embodiments described above and below may be utilized with heart valve prosthesis  500 . 
       FIG. 13  shows another embodiment of heart valve prosthesis  310 .  FIG. 13  illustrates heart valve prosthesis  310  in a radially expanded configuration. Heart valve prosthesis  310  includes a frame  314  and a prosthetic valve  312  coupled to the frame  314 . Heart valve prosthesis  310  includes a radially collapsed configuration and the radially expanded configuration. Heart valve prosthesis  310  also includes a first end  326  and a second end  332  opposite first end  326 . Frame  314  is generally tubular and defines a central passage  324 , and includes a first end  334  and a second end  336 . In the embodiment shown in  FIG. 13 , first end  334  of frame  314  defines first end  326  of heart valve prosthesis  310 . Similarly, second end  336  of frame  314  defines second end  332  of heart valve prosthesis  310 . Those skilled in the art would recognize that other features, such as skirts or arms may be included as part of heart valve prosthesis  310 . In the embodiment shown, first end  326  of heart valve prosthesis  310  is the proximal or inflow end, and second end  332  of heart valve prosthesis is the distal or outflow end of heart valve prosthesis  310 . Also, first end  334  of frame  314  is flared radially outwardly, as shown in  FIG. 13 . This outward flare at first end  334  forms an inflow rim  315  that is configured to contact an atrial side of a native mitral valve annulus. Further, although inflow rim  315  is shown as generally circular, inflow rim may be other shapes to conform to the anatomy adjacent the native mitral valve, such as but not limited D-shaped. A portion of frame  314  may also be described as an outflow portion  325 . Outflow portion  325  is generally tubular and is configured to extend through the leaflets of the native valve complex. Although heart valve prosthesis  310  as shown is configured for placement at the site of a native mitral valve, heart valve prosthesis  310  may be used at other implantation sites, such as, but not limited to, other the sites of native heart valves. 
     Frame  314  is a support structure that comprises struts  316  arranged relative to each other with a plurality of open spaces  317  therebetween. Frame  314  provides a desired compressibility and expansion force against a native annulus at the desired implantation site. Frame  314  also provides support for prosthetic valve  312 . Prosthetic valve  312  is coupled to and disposed within frame  314 . Although the embodiment of  FIG. 13  does not show the radially outward portion of inflow rim  315  bent to extend longitudinally as in  FIG. 1 , this is not limiting and heart valve prosthesis  310  of  FIG. 13  may include such a bend. Struts  316  of inflow rim  315  form a plurality of peaks  318  and valleys  320  at a first end of inflow rim  315 . 
     A plurality of torque anchoring mechanisms  322  are coupled to inflow rim  315 . Torque anchoring mechanisms  322  are configured such that when heart valve prosthesis  310  is in the radially expanded configuration at a desired implantation site, and at least a portion of heart valve prosthesis  310  is rotated, torque anchoring mechanisms  322  are embedded into tissue at the desired implantation site. As shown in  FIG. 13 , torque anchoring mechanisms  322  extend clockwise. However, they may extend counter-clockwise or partially angled in either direction. Further, torque anchoring mechanisms  322  may generally extend from an underside  319  of inflow rim  315 . The underside  319  of inflow rim  315  is the surface facing the native mitral valve annulus when the heart valve prosthesis  310  is deployed with inflow rim  315  on the atrial side of the native mitral valve annulus (i.e., the surface of the inflow rim facing the outflow end). Torque anchoring mechanisms  322  may be barbs, clips, hooks, arrows or similar devices configured to embed into tissue at the desired implantation site. While  FIG. 13  shows each torque anchoring mechanism  322  as single wire, this is not limiting and other configurations of torque anchoring mechanisms may be used. 
     Frame  314  may be formed, for example, and not by way of limitation, of nickel titanium, Nitinol, nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high spring temper steel, or any other metal or suitable for purposes of the present disclosure. Torque anchoring mechanisms  322  may be formed from the same types of materials as frame  314 . Torque anchoring mechanisms  322  may be extensions of struts  316 , or may be coupled to frame  314 , for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposed described herein. 
     Frame  314  shown in  FIG. 13  further includes a plurality of tether connection points  338 . In the embodiment shown, tether connection points  338  are shown at valleys  320 , but they may be located elsewhere on inflow rim  315 . In the embodiment shown, tether connections points  338  are openings that enable a tether of a delivery system to couple with heart valve prosthesis  310 , either by direct coupling or looping through or around, to rotate heart valve prosthesis  310  or a portion thereof to embed torque anchoring mechanisms  322  into tissue at the implantation site, as described in more detail below. 
     With the above understanding of heart valve prosthesis  310  in mind, a delivery device  400  shown in  FIGS. 14-16  may be used to deliver and deploy a heart valve prosthesis such as heart valve prosthesis  310 . In an embodiment, delivery device  400  generally includes a handle  440 , an outer shaft assembly  410 , an inner shaft assembly  404 , a tether shaft  450 , and a plurality of tethers  460 . Delivery device  400  may be made from any suitable material, such as, but not limited to polyethylene (PE), polyethylene terephthalate (PET), and polyvinylchloride (PVC). Various features of the components of delivery device  400  reflected in  FIGS. 14-16  and described below can be modified or replaced with differing structures and/or mechanisms. The components of delivery device  400  may assume different forms and construction. Therefore, the following detailed description is not meant to be limiting. Further, the systems and functions described below can be implemented in many different embodiments of hardware. Any actual hardware described is not meant to be limiting. The operation and behavior of the systems and methods presented are described with the understanding that modifications and variations of the embodiments are possible given the level of detail presented. 
     In an embodiment shown schematically in  FIGS. 14-15 , handle  440  may include a housing  442  with an actuator mechanism  444  and a rotator mechanism  470  retained therein. More particularly, handle  440  includes a cavity  443  defined by housing  442  and configured to receive portions of actuator mechanism  444  and rotator mechanism  470 . In the embodiment shown in  FIGS. 14-15 , housing  420  forms a longitudinal slot  446  through which actuator mechanism  444  extends for interfacing by a user, and a rotational slot  472  through which rotator mechanism  470  extends for interfacing by a user. Handle  440  provides a surface for convenient handling and grasping by a user, and may have a generally cylindrical shape, as shown, or other shapes. Actuator mechanism  444  is generally constructed to provide selective retraction/advancement of outer shaft assembly  410  and can have a variety of constructions and/or devices capable of providing the desired user interface. Although shown as a slide mechanism, other constructions and/or devices may be used to retract/advance outer shaft assembly  410 , such as, but to limited to rotating mechanisms, sliding mechanisms that are coaxially disposed over inner shaft assembly  404 , combinations of rotating and sliding mechanisms, and other advancement/retraction mechanisms known to those skilled in the art. Similarly, rotator mechanism  470  may be any mechanism used to rotate tethers  460 . 
     Outer shaft assembly  410  is slidably disposed over inner shaft assembly  404 . With reference to  FIGS. 14-15 , in an embodiment, outer shaft assembly  410  includes a proximal shaft  418  and a capsule  407 , and defines a lumen  412  extending from a proximal end  430  of proximal shaft  418  to a distal end  432  of capsule  407 . Although outer shaft assembly  410  is described herein as including capsule  407  and proximal shaft  418 , capsule  407  may simply be an extension of proximal shaft  418 . Further, outer shaft assembly  410  may be referred to as a sheath or outer sheath. Proximal shaft  418  is configured for connection to capsule  407  at a connection point  416  at a proximal end  409  of capsule  407  by fusing, welding, adhesive, sutures, or other means suitable for the purposes described herein. Alternatively, proximal shaft  418  and capsule  407  may be unitary. Proximal shaft  418  extends proximally from capsule  407  and is configured for connection to handle  440 . More particularly, proximal shaft  418  extends proximally into housing  442  of handle  440  and a proximal portion  431  of proximal shaft  418  is connected to actuator mechanism  444  of handle  440 . Proximal portion  431  is coupled to actuator mechanism  444  such that movement of actuator mechanism  444  causes outer shaft assembly  410  to move relative inner shaft assembly  404 . Proximal shaft  418  may be coupled to actuator mechanism  444 , for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. Outer shaft assembly  410  is thus movable relative to handle  440  and inner shaft assembly  404  by actuator mechanism  444 . However, if actuator mechanism  444  is not moved and handle  440  is moved, outer shaft assembly  410  moves with handle  440 , not relative to handle  440 . 
     Inner shaft assembly  404  is similar to inner shaft assembly  104  previously described. Inner shaft assembly  404  extends within a lumen  456  of tether shaft  450 , described in greater detail below and as shown in  FIGS. 14-15 . Inner shaft assembly  404  includes an inner shaft  414  and a distal tip  422 . Inner shaft  414  extends from a proximal end  434  of inner shaft  414  to a distal end  436  of inner shaft  414 . Distal end  436  of inner shaft  414  is attached to distal tip  422 . The components of inner shaft assembly  404  combine to define continuous guidewire lumen  423 , which is sized to receive an auxiliary component such as a guidewire (not shown). Although inner shaft assembly  404  is described herein as including inner shaft  414  and distal tip  422 , distal tip  422  may simply be an extension of inner shaft  414 . Further, inner shaft may be several pieces attached together rather than a single piece. Inner shaft  414  extends proximally into housing  442  of handle  440 , and is connected to handle  440  such that guidewire lumen  423  provides access for auxiliary components (e.g., a guidewire) therein. Inner shaft  414  may be coupled to handle  440 , for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. During sliding or longitudinal movement of outer shaft assembly  410 , inner shaft assembly  404  is fixed relative to handle  440 . However, in other embodiments, inner shaft assembly may be configured to move relative to handle  440 , such as by another actuator mechanism. 
     In an embodiment, tether shaft  450  may be coaxially disposed between inner shaft  404  and outer shaft assembly  410 . Tether shaft  450  may be rotated relative to inner shaft assembly  404  and outer shaft assembly  410 . With reference to  FIGS. 14-15 , tether shaft  450  includes a proximal shaft portion  466  and a distal shaft portion  468 , and defines lumen  456  extending from a proximal end  452  to a distal end  454  of tether shaft  450 . Proximal shaft portion  466  is configured for connection to handle  440 . Proximal shaft portion  466  of tether shaft  450  extends proximally into housing  442  of handle  440  and is connected to rotator mechanism  470  of handle  440 . Proximal shaft portion  466  is coupled to rotator mechanism  470  such that movement of rotator mechanism  470  causes tether shaft  450  to rotate about a central longitudinal axis LA c  relative to outer shaft assembly  410  and inner shaft assembly  404 . Proximal shaft portion  466  may be coupled to rotator mechanism  470 , for example, and not by way of limitation by adhesives, welding, clamping, and other coupling devices as appropriate. Tether shaft  450  is thus rotationally movable relative to housing  442 , inner shaft assembly  404 , and outer shaft assembly  410  by rotator mechanism  470 . However, if rotator mechanism  470  is not moved and housing  442  is moved, tether shaft  450  moves with housing  442 , not relative to housing  442 . A plurality of tether connection points  458  are located at distal shaft portion  468  of tether shaft  450 , proximal of distal end  464 . Tether connection points  458  are configured to couple distal shaft portion  468  of tether shaft  450  to tethers  460  as described below. While  FIG. 16  shows tether connection points  458  arranged circumferentially around tether shaft  450 , this is not meant to limit the design and other configurations are contemplating based upon the application. Non-limiting examples of the connection of tethers  460  to tether connection points  458  include configurations releasable by manipulation of the outer shaft  410  such as retainer posts and knot/ball retention apertures, configurations releasable by severing/cutting the tether, and other configurations suitable for the purposes described herein. 
     In an embodiment, tethers  460  includes a first end  462  coupled to a respective tether connection point  338  of heart valve prosthesis  310 , and a second end  464  coupled to tether connection points  458  of tether shaft  450 , as shown in  FIG. 15 . 
     Tethers  460  are elongated members such as wires. Tethers  460  are relatively rigid such that rotation of tethers  460  increases tautness of tethers  460  such that when taut, rotational torque applied to tethers  460  is transmitted to heart valve prosthesis  310  to rotate heart valve prosthesis  310 . Tethers  460  may be connected to tether shaft  450  by methods such as, but not limited to fusing, welding, or mechanical connections. Alternatively, tethers  460  may extend through tether shaft  450  to driver mechanisms (not shown), such as but not limited to sliders, buttons, knobs, and similar mechanisms, to rotate tethers  460  and to release tethers  460  from heart valve prosthesis  310 . Tethers  460  may be releasably connected to connection points  338  and tether connection points  458  in any manner suitable for the purpose herein; namely, a sufficiently rigid connection such that rotation of tethers  460  is transmitted to heart valve prosthesis  310  and a removable connection. In an alternative embodiment, first ends  462  of tethers  460  may be coupled to a respective tether connection points  458  of tether shaft  450 , and second ends  464  of tethers  460  are releasably coupled to corresponding tether connection points  458  of tether shaft  450 . In an embodiment, a portion of each tether  460  is looped through open spaces  17  and around struts  16  of frame  14  at corresponding tether connection points  338 . 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 15 , heart valve prosthesis  310  is disposed in a radially compressed configuration within capsule  407  of outer shaft assembly  410 . In this delivery configuration, tethers  460  are coupled to heart valve prosthesis  310  and connection points  338 . Delivery device  400  is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  410  is retracted proximally, thereby retracting capsule  407  proximally. Capsule  407  is retracted proximally sufficient to expose heart valve prosthesis  310 . In the embodiment shown, heart valve prosthesis  310  is self-expanding. Therefore, retraction of capsule  407  enables heart valve prosthesis  310  to self-expand to the radially expanded configuration, as shown in  FIG. 16 . User actuation of rotator mechanism  470  in direction R r  relative to central longitudinal axis LA c  rotates tether shaft  450  in direction R r  such that tethers  460  are rotated in direction R r . Rotation of tethers  460  imparts a rotational force in direction R r  on inflow rim  315  of heart valve prosthesis  310  such that at least a portion of heart valve prosthesis  310  rotates in direction R r  such that torque anchoring mechanisms  322  are embedded in tissue at the desired implantation site. Stated another way, with heart valve prosthesis  310  in the radially expanded configuration at the desired implantation site, tethers  460  are rotated in direction R r  to embed anchoring mechanisms  322  in tissue, thereby anchoring heart valve prosthesis  310  at the desired implantation site. In an alternative embodiment, tethers  460  are looped through heart valve prosthesis  310  around connection points  338 . Once heart valve prosthesis  310  is anchored, outer shaft  410  is retracted further proximally, releasing the second ends  464  of tethers  460  from tether shaft  450  such that tethers  460  may be removed with delivery device  400 . In other embodiments, tethers  460  may be released from tether shaft  450  and remain with heart valve prosthesis  310 . In yet another embodiment, tethers  460  may be severed and a portion coupled to tether shaft  450  removed with delivery device  400  and a portion coupled to heart valve prosthesis  310  remaining with heart valve prosthesis  310 . 
       FIGS. 17-19  illustrate another embodiment of delivery device  400 ′ for delivering and deploying a heart valve prosthesis  10 . Delivery device  400 ′ is similar to the embodiment of  FIGS. 14-16 , so only the differences between the embodiments will be described in detail here. Features not specifically described may be like those described with respect to the embodiment of  FIGS. 14-16 , or other embodiments described herein. In the embodiment of  FIGS. 17-19 , instead of a tether shaft  450  and tethers  460 , as described above, delivery device  400 ′ includes a rod shaft  450 ′ and rods  460 ′. 
     In an embodiment, rod shaft  450 ′ may be coaxially disposed between inner shaft  404  and outer shaft assembly  410 . Rod shaft  450 ′ may be rotated relative to inner shaft assembly  404  and outer shaft assembly  410 . With reference to  FIGS. 17-18 , rod shaft  450 ′ includes a proximal shaft portion  466 ′ and a distal shaft portion  468 ′, and defines a lumen  456 ′ extending from a proximal end  452 ′ to a distal end  454 ′ of rod shaft  450 ′. Proximal shaft portion  466 ′ is configured for connection to handle  440 . Proximal shaft portion  466  of rod shaft  450 ′ extends proximally into housing  442  of handle  440  and is connected to rotator mechanism  470  of handle  440 . Proximal shaft portion  466 ′ is coupled to rotator mechanism  470  such that movement of rotator mechanism  470  causes rod shaft  450 ′ to rotate about a central longitudinal axis LA c  relative to outer shaft assembly  410  and inner shaft assembly  404 . Proximal shaft portion  466 ′ may be coupled to rotator mechanism  470 , for example, and not by way of limitation by adhesives, welding, clamping, and other coupling devices as appropriate. Rod shaft  450 ′ is thus rotationally movable relative to housing  442 , inner shaft assembly  404 , and outer shaft assembly  410  by rotator mechanism  470 . However, if rotator mechanism  470  is not moved and housing  442  is moved, rod shaft  450 ′ moves with housing  442 , not relative to housing  442 . A plurality of rod connection points  458 ′ are located at distal shaft portion  468  of rod shaft  450 ′. Rod connection points  458 ′ are configured to pivotably couple distal shaft portion  468 ′ of rod shaft  450 ′ to rods  460 ′ as described below. While  FIG. 19  shows rod connection points  458 ′ arranged circumferentially around rod shaft  450 ′, this is not meant to limit the design and other configurations are contemplating based upon the application. 
     In an embodiment, each rod  460 ′ includes an atraumatic first end  462 ′ and a second end  464 ′. Each second end  464 ′ is pivotably coupled to a corresponding rod connection point  458 ′ of rod shaft  450 ′, as shown in  FIG. 17 . Rods  460 ′ are elongated rigid members such as wires. Rods  460 ′ include a pivotably collapsed configuration when disposed within outer shaft assembly  410 , and a pivotably expanded configuration with first ends  462 ′ radially expanded outward from inner shaft  414 , and second ends  464 ′ pivotably coupled to rod shaft  450 ′, as shown in  FIG. 19 . Rods  460 ′ are self-expanding in that they remain in the pivotably expanded configuration unless compressed to the pivotably collapsed configuration when retained within capsule  407  and outer shaft  410 . When in the pivotably expanded configuration, first ends  462 ′ are radially expanded to a first diameter D 1 . First diameter D 1  is equal to the diameter of connection points  338 ′ such that advancement distally of delivery device  400 ′ selectively couples first ends  462 ′ with connection points  338 ′ on a torque portion  350  of heart valve prosthesis  310 . First ends  462 ′ will remain selectively coupled with connection points  338 ′ with continued distal force on delivery device  400 ′. When selectively coupled, rotation of rod shaft  450 ′ and pivotably coupled rods  460 ′ is transmitted to heart valve prosthesis  310  to rotate heart valve prosthesis  310 . Rods  460 ′ may be pivotably connected to rod shaft  450 ′ by methods such as, but not limited to fusing, welding, flex-joint, or mechanisms suitable for the purposes described herein. Rods  460 ′ may be selectively coupled to connection points  338 ′ by various methods such as, but not limited to rod-cup mechanisms, rod-slot mechanisms, friction-fit mechanisms, or other methods suitable for the purposes described herein. 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained herein. As shown in  FIG. 18 , heart valve prosthesis  310  is disposed in a radially compressed configuration within capsule  407  of outer shaft assembly  410 . In this delivery configuration, rods  460 ′ are retained in the pivotably collapsed configuration within capsule  407  and outer shaft  410  with first ends  462 , selectively coupled to heart valve prosthesis  310  at rod connection points  338 ′. Delivery device  400 ′ is delivered to an implantation site, such as the site of a native mitral valve. When at the implantation site, outer shaft assembly  410  is retracted proximally, thereby retracting capsule  407  proximally. Capsule  407  is retracted proximally sufficient to expose heart valve prosthesis  310 . In the embodiment shown, heart valve prosthesis  310  is self-expanding. Therefore, retraction of capsule  407  enables heart valve prosthesis  310  to self-expand to the radially expanded configuration. Once heart valve prosthesis is in the radially expanded configuration, outer shaft assembly  410  is retracted further proximally, thereby retracting capsule  407  proximally. Capsule  407  is retracted proximally sufficient to expose rods  460 ′. In the embodiment shown, rods  460 ′ are self-expanding. Therefore, retraction of capsule  407  enables rods  460 ′ to self-expand to the pivotably expanded configuration, as shown in  FIG. 19 . With rods  460 ′ in the pivotably expanded configuration, delivery device  400 ′ is advanced distally until each first end  462 ′ is selectively coupled with a corresponding connection point  338 ′ of heart valve prosthesis  310 . Once selectively coupled by distal force on delivery device  400 ′ user actuation of rotator mechanism  470  in direction R r  relative to central longitudinal axis LA c  rotates rod shaft  450 ′ in direction R r  such that rods  460 ′ are rotated in direction R r . Rotation of rods  460 ′ imparts a rotational force in direction R r  heart valve prosthesis  310  such that at least a portion of heart valve prosthesis  310  rotates in direction R r  such that torque anchoring mechanisms  322  are embedded in tissue at the desired implantation site. Once heart valve prosthesis  310  is anchored, delivery device  400 ′ is retracted proximally such that rods  460 ′ are selectively uncoupled form connection points  338 ′. When rods  460 ′ are selectively uncoupled form connection points  338 , outer shaft assembly  410  is advanced distally, thereby advancing capsule  407  distally. Capsule  407  is advanced distally sufficient to radially compress rods  460 ′ to the pivotably collapsed configuration. Delivery device  400 ′ may be then be retracted proximally for removal from the implantation site. While rod shaft  450 ′ and rods  460 ′ are described herein as part of delivery device  400 ′, this is not meant to limit the design, and in other embodiments, rod shaft  450 ′ and rods  460 ′ may be a separate device advanced to the implantation site following the expansion of heart valve prosthesis  310  and removal of delivery device  400 ′. 
     Features of any of the embodiments described above may be used with any of the other embodiments described above. Further, variations in the number and types of tethers, rods, shafts, actuating mechanisms, and similar items may be made within the scope of the invention. Other materials than those described above may also be used within the scope of the invention. 
     A method of deploying and anchoring a heart valve prosthesis at a desired implantation site with a delivery device in accordance with an embodiment hereof is schematically represented in  FIGS. 20-24 . The method steps of  FIGS. 20-24  are described with respect to delivery device  100 ′″ including dumbbell-shaped balloon  170 . However, this embodiment may be used with other delivery devices described herein. Using established percutaneous transcatheter delivery procedures, delivery device  100 ′″ is introduced into a patient&#39;s vasculature, advanced over a guidewire, and positioned at a treatment site of a damaged or diseased native valve, which in this embodiment is a native mitral valve  730  of a heart  700 , as shown in  FIG. 20 . 
     With delivery device  100 ′″ in place, actuator mechanism  144  of handle  140  is operated proximally to outer shaft assembly  110 . As capsule  107  of outer shaft assembly  110  is retracted proximally, heart valve prosthesis  10  transitions from the radially collapsed configuration to the radially expanded configuration, as shown in  FIG. 21 . 
     Once heart valve prosthesis  10  is in the radially expanded configuration, inflation fluid is injected into dumbbell-shaped balloon  170  such that dumbbell-shaped balloon  170  transitions from the uninflated configuration to the inflated configuration as shown in  FIG. 22 . Balloon  170  is configured such that when in the inflated configuration, shaped end  174  of first portion  172  of dumbbell-shaped balloon  170  engages corresponding shaped end  26  of heart valve prosthesis  10 , proximal end  182  of second portion  180  of dumbbell-shaped balloon  170  abuts proximal end  34  of heart valve prosthesis  10 , and outer surface  189  (not shown in  FIGS. 20-24 ) of third portion  186  of dumbbell-shaped balloon  170  engages the inner surface of frame  14  of heart valve prosthesis  10 . 
     Next, delivery device  100 ′″ is rotated in direction R r  about central longitudinal axis LA c . Rotation of delivery device  100 ′″ in direction R r  about central longitudinal axis LA c , rotates dumbbell-shaped balloon  170  in direction R r , which rotates at least a portion of heart valve prosthesis  10  in direction R r , and torque anchoring mechanism  22  is embedded into tissue at the desired implantation site, as shown in  FIG. 23 . 
     Next, inflation fluid is drained from dumbbell-shaped balloon  170  such that dumbbell-shaped balloon  170  transitions from the inflated configuration to the first uninflated configuration. Delivery device  100 ′″ is retracted through patient&#39;s vasculature, leaving heart valve prosthesis  10  anchored in at the site of the native mitral valve, as shown in  FIG. 24 . 
     The method described with respect to  FIGS. 20-24  may be used with other devices and features described herein. Further, variations, additional steps, and fewer steps may be utilized as would be understood by those skilled in the art. 
     Another method of deploying and anchoring a heart valve prosthesis at a desire implantation site with a delivery device in accordance with an embodiment hereof is schematically represented in  FIGS. 25-29 . The method steps of  FIGS. 25-29  are described with respect to delivery device  400  and heart valve prosthesis  310  described previously. Using established percutaneous transcatheter delivery procedures, delivery device  400  is introduced into a patient&#39;s vasculature, advanced over a guidewire, and positioned at a treatment site of a damaged or diseased native valve, which in this embodiment is native mitral valve  730  of heart  700 , as shown in  FIG. 25 . 
     Actuator mechanism  444  of handle  440  is operated proximally to retract outer shaft assembly  410 . As capsule  407  of outer shaft assembly  410  is retracted proximally, heart valve prosthesis  310  transitions from the radially collapsed configuration to the radially expanded as shown in  FIG. 26 . 
     With heart valve prosthesis  310  in the radially expanded configuration, shown in  FIG. 27 , rotator mechanism  470  of handle  440  is rotated in direction R r  about central longitudinal axis LA c . Rotation of rotator mechanism  470  causes tether shaft  450  and tethers  460  attached thereto to rotate in direction R r . Rotation tethers  460  causes least a portion of heart valve prosthesis  310  to rotate in direction R r , thereby embedding torque anchoring mechanisms  322  of heart valve prosthesis  310  into tissue at the desired implantation site, as shown in  FIG. 28 . 
     Tethers  460  may then be released from heart valve prosthesis  310 , as described above. Delivery device  400  may then be removed from the patient, leaving heart valve prosthesis  310  anchored in heart  700 , as shown in  FIG. 29 . 
     The method described with respect to  FIGS. 25-29  may be used with other devices and features described herein. Further, variations, additional steps, and fewer steps may be utilized as would be understood by those skilled in the art. For example, and not by way of limitation, delivery device  400  may be used with the heart valve prosthesis described with respect to  FIGS. 10A-11D  above, or the heart valve prostheses described with respect to  FIG. 35 , below. 
     Another method of deploying and anchoring a heart valve prosthesis at a desire implantation site with a delivery device in accordance with an embodiment hereof is schematically represented in  FIGS. 30-34 . The method steps of  FIGS. 30-34  are described with respect to delivery device  400 ′ and heart valve prosthesis  310  described previously. Using established percutaneous transcatheter delivery procedures, delivery device  400 ′ is introduced into a patient&#39;s vasculature, advanced over a guidewire, and positioned at a treatment site of a damaged or diseased native valve, which in this embodiment is native mitral valve  730  of heart  700 , as shown in  FIG. 30 . 
     Actuator mechanism  444  of handle  440  is operated proximally to retract outer shaft assembly  410 . As capsule  407  of outer shaft assembly  410  is retracted proximally, heart valve prosthesis  310  transitions from the radially collapsed configuration to the radially expanded configuration. With the heart valve prosthesis  310  in the radially expanded configuration, delivery device  400 ′ is advanced distally. Actuator mechanism  444  of handle  440  is operated proximally to retract outer shaft assembly  410 . As capsule  407  of outer shaft assembly  410  is retracted proximally, rods  460 ′ of rod shaft  450 ′ transition from the pivotably collapsed configuration to the pivotably expanded configuration. Delivery device  400 ′ is advanced distally and rods  460 ′ engage connection points  338 ′ of heart valve prosthesis  310 , as shown in  FIG. 31 . 
     With heart valve prosthesis  310  in the radially expanded configuration, shown in  FIG. 32  and rods  460 ′ engaged thereto, rotator mechanism  470  of handle  440  is rotated in direction R r  about central longitudinal axis LA c . Rotation of rotator mechanism  470  causes rod shaft  450 ′ and rods  460 ′ attached thereto to rotate in direction R r . Rotation of rods  460 ′ causes at least a portion of heart valve prosthesis  310  to rotate in direction R r , thereby embedding torque anchoring mechanisms  322  of heart valve prosthesis  310  into tissue at the desired implantation site, as shown in  FIG. 33 . 
     Delivery device  400 ′ may then be retracted proximally such that rods  460 ′ disengage and are released from connection points  338 ′ of heart valve prosthesis  310 . Outer shaft  410  (including capsule  407 ) is advanced distally and rods  460 ′ radially compress from the pivotably expanded configuration to the pivotably collapsed configuration. Delivery device  400 ′ may then be removed from the patient, leaving heart valve prosthesis  310  anchored in heart  700 , as shown in  FIG. 34 . 
     The method described with respect to  FIGS. 30-34  may be used with other devices and features described herein. Further, variations, additional steps, and fewer steps may be utilized as would be understood by those skilled in the art. 
       FIGS. 35-36  schematically show another embodiment of a heart valve prosthesis  600 . Heart valve prosthesis  600  is similar to the heart valve prostheses described above, and thus will not be described in detail. Heart valve prosthesis  600  includes a frame  614  and a prosthetic valve  612 . Frame  614  defines a central passage  624  in which prosthetic valve  612  is disposed. Frame  614  also defines an inflow rim  615  and an outflow tube  625 . Inflow rim  615  includes a plurality of torque anchoring mechanisms  622  coupled thereto, as described above. Heart valve prosthesis  600  also includes a plurality of arms  650  coupled to outflow tube  625 . Arms  650  are shown folded back such that arms  650  are disposed outside of an outer surface of outflow tube  625 . Each arm  650  may be configured to capture a native leaflet of a native valve between the arm and the outer surface of outflow tube  625 . Arms  650  may extending longitudinally away from the outflow end of outflow tube  625  when in the radially compressed delivery configuration, and then fold back into the position shown in  FIG. 35  when radially expanded. Using a heart valve prosthesis with arms  650  to capture the native leaflets between the arms  650  and outflow tube  625 , it is not desirable to rotate such a heart valve prosthesis to embed torque anchoring mechanisms  622  into tissue adjacent the native valve because such toque is transferred to arms  650  and the native valve leaflets. 
     Thus, in the embodiment shown in  FIG. 35 , inflow rim  615  is decoupled from outflow tube  625 . By “decoupled”, it is meant that inflow rim  615  may be rotated at least partially without rotating outflow tube  625 . In the embodiment shown in  FIG. 35 , inflow rim  615  is decoupled from outflow tube  625  using a joint  640 . Joint  640  may be a flexible material such as, but not limited to a fabric material (e.g., polyester, nylon, etc.) A first end  642  of joint  640  is attached to inflow rim  615  and a second end  644  of joint  640  is attached to outflow tube  625 . Joint  640  may be coupled to inflow rim  615  and outflow tube  625  by sutures, adhesives, and other connections suitable for the purposes described herein. Using heart valve prosthesis  600  with joint  640 , after heart valve prosthesis is radially expanded at the treatment site with the native valve leaflets captured between arms  650  and outflow tube  625 , inflow rim  615  may be rotated to embed torque anchoring mechanisms  622  without rotating outflow tube  625 . Instead, joint  640  twists to absorb the rotation of inflow rim  615 . Inflow rim  615  may be rotated by any of the devices and methods described above. 
     In another embodiment, instead of joint  640  being a flexible material, inflow rim  615  and outflow tube  625  may be connected to each other in a manner that permits relative rotation there between, but does not permit longitudinal separation.  FIG. 36  shows an example of such a joint  670 . In the embodiment shown, inflow rim  615  includes a tubular portion  680  extending towards outflow tube  625 . An end of tubular portion  680  opposite inflow rim  615  includes a lip  674 . Outflow tube  625  includes an end opposite the outflow end with a groove  672 . Lip  674  is disposed in groove  672 . Such a connection enables inflow rim  615  to rotate relative to outflow tube  625  while keeping inflow rim  615  and outflow tube  625  coupled to each other. 
     Using heart valve prosthesis  600  with joint  670 , after heart valve prosthesis is radially expanded at the treatment site with the native valve leaflets captured between arms  650  and outflow tube  625 , inflow rim  615  may be rotated to embed torque anchoring mechanisms  622  without rotating outflow tube  625 . Inflow rim  615  may be rotated by any of the devices and methods described above. 
     While only some embodiments have been described herein, it should be understood that it has been presented by way of illustration and example only, and not limitation. Various changes in form and detail can be made therein without departing from the spirit and scope of the invention, and each feature of the embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. Further, features of any of the embodiments described herein may be used with any of the other embodiments described herein. All patents and publications discussed herein are incorporated by reference herein in their entirety.