Abstract:
A delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient&#39;s vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient&#39;s vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.

Description:
CROSS-REFERENCE 
       [0001]    The present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 62/267,722 (Attorney Docket No. 42194-727.101) filed Dec. 15, 2015; the entire contents of which are incorporated herein by reference. 
         [0002]    The present application is related to U.S. patent application Ser. No. 13/096,572 (Attorney Docket No. 42194-703.201, now U.S. Pat. No. 8,579,964), filed Apr. 28, 2011; the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention generally relates to medical devices and methods, and more particularly relates to prosthesis delivery systems used in the treatment of valve insufficiency, such as mitral insufficiency, also referred to as mitral regurgitation. 
         [0005]    The heart of vertebrate animals is divided into four chambers, and is equipped with four valves (the mitral, aortic, pulmonary and tricuspid valves) that ensure that blood pumped by the heart flows in a forward direction through the cardiovascular system. The mitral valve of a healthy heart prevents the backflow of blood from the left ventricle into the left atrium of the heart, and comprises two flexible leaflets (anterior and posterior) that close when the left ventricle contracts. The leaflets are attached to a fibrous annulus, and their free edges are tethered by subvalvular chordae tendineae to papillary muscles in the left ventricle to prevent them from prolapsing into the left atrium during the contraction of the left ventricle. 
         [0006]    Various cardiac diseases or degenerative changes may cause dysfunction in any of these portions of the mitral valve apparatus, causing the mitral valve to become abnormally narrowed or dilated, or to allow blood to leak (i.e. regurgitate) from the left ventricle back into the left atrium. Any such impairments compromise cardiac sufficiency, and can be debilitating or life threatening. 
         [0007]    Numerous surgical methods and devices have accordingly been developed to treat mitral valve dysfunction, including open-heart surgical techniques for replacing, repairing or reshaping the native mitral valve apparatus, and the surgical implantation of various prosthetic devices such as annuloplasty rings to modify the anatomy of the native mitral valve. However, these devices require open heart surgery which requires a lengthy recovery period for the patient and is costly. More recently, less invasive transapical and transcatheter techniques for the delivery of replacement mitral valve assemblies have been developed. In such techniques, a prosthetic valve is generally mounted in a crimped state on the end of a flexible catheter or delivery system and advanced through a blood vessel or the body of the patient until the valve reaches the implantation site. The prosthetic valve is then expanded to its functional size at the site of the defective native valve. 
         [0008]    While these devices and methods are promising treatments for valvar insufficiency, they can be difficult to deliver, expensive to manufacture, or may not be indicated for all patients. Additionally some of the delivery systems have large sizes which create large entry wounds in the body. Therefore, it would be desirable to provide improved devices and methods for the treatment of valvar insufficiency such as mitral insufficiency. It would be desirable if such delivery devices had smaller profiles, were easily advanced or steered to the target treatment site, and allowed accurate delivery and deployment of the prosthesis At least some of these objectives will be met by the devices and methods disclosed below. 
         [0009]    2. Description of the Background Art 
         [0010]    US Patent Publication No. 2015/0342736 describes a prosthetic valve delivery system. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention generally relates to medical systems, devices and methods, and more particularly relates to prosthesis delivery systems used in the treatment of valve insufficiency, such as mitral insufficiency, also referred to as mitral regurgitation. 
         [0012]    In one aspect, a delivery system for delivering a prosthesis to a target treatment area comprises an inner guidewire catheter, a distal capsule coupled to the distal end of the inner guidewire catheter, and a sheath catheter slidably disposed over the inner guidewire catheter, the sheath catheter having a proximal end and a distal end. The delivery system can further comprise a proximal capsule coupled to the distal end of the sheath catheter and an actuator mechanism operably coupled with the inner guidewire catheter and the sheath catheter. The inner guidewire catheter can have a proximal end, a distal end, and a lumen extending therebetween, the lumen sized to slidably receive a guidewire and the distal capsule can comprise an inner channel sized to receive the prosthesis. The proximal capsule can also comprise an inner channel sized to receive the prosthesis. Additionally, actuation of the actuator mechanism in a first direction can move the proximal capsule away from the distal capsule thereby removing a constraint from the prosthesis and allowing the prosthesis to expand while actuation of the actuator mechanism in a second direction opposite the first direction can move the proximal capsule into engagement with the distal capsule thereby enclosing the prosthesis therein. 
         [0013]    The delivery system can comprise a bell catheter slidably disposed over the guidewire catheter. The bell catheter can have a bell element disposed adjacent a distal end of the bell catheter. An anchor catheter can be slidably disposed over the bell catheter, the anchor catheter having an anchor element adjacent a distal end of the anchor catheter and configured to engage the prosthesis, and wherein the bell member can constrain the prosthesis into engagement with the anchor element. 
         [0014]    The delivery system can comprise a steerable catheter having an actuator mechanism. The inner guidewire catheter and the sheath catheter can be slidably disposed in the steerable catheter, and actuation of the actuator mechanism can steer the steerable catheter, thereby steering the inner guidewire catheter and the sheath catheter. The steerable catheter can comprise a plurality of pull wires coupled to the steerable catheter. Moreover, actuation of the actuator mechanism can move the pull wires thereby steering the steerable catheter. 
         [0015]    The actuator mechanism for steering the steerable catheter can comprise a rotatable knob and the delivery system can further comprise a handle coupled to a proximal portion of the delivery system. The actuator mechanism can be coupled to the handle. The actuator mechanism can comprise a plurality of rotatable thumbwheels. 
         [0016]    The distal capsule can comprise an expandable member and the expandable member can comprise a stent or a balloon. The distal capsule can comprise a corrugated region. In some embodiments, the distal capsule can comprise a plurality of hinged splines that can be configured to radially expand at a hinge when compression is applied to the plurality of hinged splines. The distal capsule can comprise a proximal portion, a distal portion, and a plurality of filaments, wherein movement of the filaments can move the proximal portion relative to the distal portion thereby increasing or decreasing a length of the distal capsule. 
         [0017]    The delivery system can also comprise a prosthesis and the prosthesis can be a prosthetic mitral valve. 
         [0018]    In another aspect, a method for delivering a prosthesis to a target treatment area comprises: providing a delivery system having a distal capsule coupled to an inner guidewire catheter and a proximal capsule coupled to a sheath catheter; actuating an actuation mechanism thereby moving the proximal capsule away from the distal capsule; releasing a constraint from a prosthesis disposed in the proximal and distal capsules; and deploying the prosthesis in the target treatment area. In some embodiments, the inner guidewire catheter can be slidably disposed in the sheath catheter, and actuating the actuation mechanism can move the inner guidewire catheter relative to the sheath catheter. In addition, actuating the actuation mechanism can comprise rotating a thumbwheel. 
         [0019]    The delivery system can further comprise a bell catheter slidably disposed over the guidewire catheter, wherein the bell catheter can have a bell element disposed adjacent a distal end of the bell catheter, and wherein deploying the prosthesis can comprise moving the bell element away from the prosthesis thereby removing a constraint from the prosthesis. 
         [0020]    In some embodiments, the delivery system can comprise an anchor catheter slidably disposed over the bell catheter, wherein the anchor catheter can have an anchor element adjacent a distal end of the anchor catheter and configured to engage the prosthesis, and wherein deploying the prosthesis can comprise moving the bell member away from the anchor element thereby removing a constraint from the prosthesis. 
         [0021]    The method for delivering a prosthesis to a target treatment area can comprise steering the delivery system with a steerable catheter disposed over the delivery system. Moreover, steering can comprise actuating an actuator mechanism operably coupled to the steerable catheter and actuating an actuator mechanism can comprise moving a plurality of pull wires coupled to the steerable catheter. In some embodiments, steering can comprise rotating a rotatable knob. 
         [0022]    The distal capsule can comprise an expandable member and the method disclosed herein can further comprise radially expanding or radially collapsing the expandable member, which can comprise a stent or a balloon. Additionally, the distal capsule can comprise a corrugated region and the method disclosed herein can further comprise axially expanding or axially collapsing the corrugated region. The distal capsule can also comprise a plurality of hinged splines and the method disclosed herein can further comprise radially expanding the hinged splines by applying compression thereto, or radially collapsing the hinged splines by applying tension thereto. The distal capsule can comprise a proximal portion, a distal portion, and a plurality of filaments, and the method disclosed herein can further comprise moving the filaments thereby moving the distal capsule toward or away from the proximal capsule. The target treatment area can be a native mitral valve and the prosthesis can be a prosthetic mitral valve. 
         [0023]    In still another aspect, a delivery system for delivering a prosthesis to a target treatment area, comprises: a delivery catheter for delivering the prosthesis to the target treatment area and a steerable catheter operably coupled with the delivery catheter, the steerable catheter comprising an actuator mechanism, wherein actuation of the actuator mechanism steers the steerable catheter, thereby also steering the delivery catheter. 
         [0024]    In some embodiments, the steerable catheter can comprise a plurality of pull wires coupled to the steerable catheter, and actuation of the actuator mechanism can move the pull wires thereby steering the steerable catheter. In addition, the actuator mechanism for steering the steerable catheter can comprise a rotatable knob and the delivery system can further comprise a handle that can be coupled to a proximal portion of the delivery catheter, wherein the actuator mechanism can be coupled to the handle. The delivery system can further comprise a prosthesis, which can be a prosthetic mitral valve. 
         [0025]    In another aspect, a method for delivering a prosthesis to a target treatment area comprises: providing a delivery catheter carrying the prosthesis; providing a steering catheter operably coupled to the delivery catheter; actuating an actuation mechanism thereby steering the steering catheter and steering the delivery catheter; and deploying the prosthesis in the target treatment area. Actuating the actuation mechanism can comprise rotating a knob and actuating the actuator mechanism can comprise moving a plurality of pull wires coupled to the steering catheter. The target treatment area can be a native mitral valve and the prosthesis can be a prosthetic mitral valve. 
       INCORPORATION BY REFERENCE 
       [0026]    All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0027]    The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: 
           [0028]      FIG. 1  is a perspective view of a trans-septal delivery system for a prosthetic heart valve. 
           [0029]      FIGS. 2A-2F  are sequential views of the procedural pathway traversed by the prosthesis during a trans-septal implantation procedure. 
           [0030]      FIGS. 3A-3D  are sequential views of the procedural pathway traversed by the prosthesis during a trans-aortic implantation procedure. 
           [0031]      FIG. 4  is an assembly view of the delivery system seen in  FIG. 1 . 
           [0032]      FIG. 5  is an assembly view of the delivery handle portion of the delivery system seen in  FIG. 1 . 
           [0033]      FIG. 6  is an assembly view of the steering guide portion of the delivery system seen in  FIG. 1 . 
           [0034]      FIG. 7  is an assembly view of the delivery catheter portion of the delivery system seen in  FIG. 1 . 
           [0035]      FIG. 8A  is a side view of the delivery system in  FIG. 1 . 
           [0036]      FIG. 8B  is a cross-sectional view of the delivery system taken along line A-A in  FIG. 8A . 
           [0037]      FIGS. 8C-8D  show other cross-sections of the delivery system. 
           [0038]      FIGS. 9A-9C  are cross-sectional views of the steering handle portion taken along the line A-A in  FIG. 8A . 
           [0039]      FIGS. 10A-10D  are sequential views of the steering handle portion of the delivery system of  FIG. 1 . 
           [0040]      FIGS. 11A-11E  are sequential cross-sectional views of the valve capsule portion taken along the line A-A in  FIG. 8A . 
           [0041]      FIGS. 12A-12D  are sequential partial views of an alternative embodiment of the valve capsule portion of the delivery system of  FIG. 1 . 
           [0042]      FIGS. 13A-13D  are sequential partial views of an alternative embodiment of the valve capsule portion of the delivery system of  FIG. 1 . 
           [0043]      FIGS. 14A-14D  are sequential partial views of an alternative embodiment of the valve capsule portion of the delivery system of  FIG. 1 . 
           [0044]      FIGS. 15A-15D  are sequential partial views of an alternative embodiment of the valve capsule portion of the delivery system of  FIG. 1 . 
           [0045]      FIGS. 16A-16D  are sequential partial views of an alternative embodiment of the valve capsule portion of the delivery system of  FIG. 1 . 
           [0046]      FIG. 17A  is a perspective view of a prosthetic mitral valve. 
           [0047]      FIG. 17B  is a top view of the prosthetic valve in  FIG. 17A . 
           [0048]      FIG. 18A  illustrates a perspective view of the prosthetic valve in  FIG. 17A . 
           [0049]      FIG. 18B  illustrates a perspective view of the prosthetic valve in  FIG. 17A . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0050]    Specific embodiments of the disclosed device, delivery system, and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention. 
         [0051]    Trans-Septal Delivery System 
         [0052]    Referring initially to  FIG. 1 , one embodiment of a trans-septal delivery system for trans-catheter heart valve delivery is depicted generally as  1 . In the drawings and in the descriptions which follow, the term “proximal” will refer to the end  2  of the delivery system that is closest to the user, while the term “distal” will refer to the end  3  that is farthest from the user. The trans-septal delivery system  1  can comprise a prosthesis such as a prosthesis capsule or valve capsule assembly  8 , a delivery catheter assembly  7 , a steering guide  10 , a delivery handle assembly  4 , and an interface  9  between the delivery handle  4  and steering handle  5 . The steering guide  10  can be comprised of a steerable catheter assembly  6  and a steering handle  5 . The valve capsule assembly  8  can be in operable communication with the delivery handle assembly  4  by way of the delivery catheter assembly  7  which extends therebetween. The translational position and angular attitude of the prosthesis or valve capsule assembly  8  can be operably controlled by the steering handle  5  and in communication by way of the steerable catheter assembly  6  which extends therebetween. The interface  9  can be comprised of a slidable seal, such as an o-ring type seal. The interface  9  can further function to allow the delivery handle or delivery catheter to translate within the steering handle while maintaining some stiction, thus preventing blood or other fluid from seeping out of the steering handle should such blood or fluid make its way up the steering catheter assembly. 
         [0053]    Further details of a trans-catheter mitral valve or any prosthesis that may be used with any of the delivery devices described herein, along with other related delivery catheters are described in commonly owned U.S. Pat. No. 8,579,964 to Lane et. al., the entire contents of which are incorporated by reference herein. 
         [0054]    Generally, delivery handle assembly  4  includes a distal actuator such as a thumbwheel  11  and a proximal actuator such as a thumbwheel  12 , both of which are integrally associated with the delivery handle assembly  4 , which is comprised of an A-side delivery handle housing  22 , and a B-side delivery handle housing  23 . Distal thumbwheel  11  and proximal thumbwheel  12  are also rotatably positionable with respect to the delivery handle assembly  4 , serving as actuators by way of internal threads (not shown) and enabling translational control of various catheters within the delivery catheter assembly  7 , further evidence of which will be detailed in a later section. The delivery handle assembly  4  is operatively coupled to the valve capsule assembly  8  via the delivery catheter assembly  7 , which functions in one aspect as a motion translation agent. In some embodiments, the delivery handle assembly  4 , delivery catheter assembly  7  and valve capsule assembly  8  can form a delivery system  26 . In some embodiments, the steering handle  5  and steerable catheter assembly  7  can form a steering guide  10 , which provides a path through which the delivery system  26  can translate and rotate, and from which it may take its shape in order to traverse tortuous vasculature during implantation. Taken altogether, the delivery system  26  and steering guide  10  can form the trans-septal delivery system  1 . 
         [0055]    Valve capsule assembly  8  may exhibit various constructions. For example, the distal capsule  14  and proximal capsule  13  may be formed from substantially rigid, stainless steel, polymer, metal or otherwise rigid tubing, from collapsible, flexible tubing, or from shape-settable exotic metal alloys which exhibit shape memory characteristics and are actuated by temperature gradients inherent to the human physiology, such as nitinol. Presently, portions of the valve capsule assembly  8  can be translatably controlled by the turning of either the distal thumbwheel  11 , or the proximal thumbwheel  12 , located in the delivery handle assembly  4 . By rotating the distal thumbwheel  11 , the proximal capsule  14  can be translatably positioned along the axis of the capsule assembly  8  in order to reveal certain portions of the prosthesis such as a prosthetic mitral valve for example, as shown in  FIGS. 17A-17B and 18A -A 8 B, that is entrained within. By rotating the proximal thumbwheel  12 , the proximal capsule  13  can be translatably positioned along the axis of the valve capsule assembly  8 , again preferably revealing and releasing certain portions of the prosthetic valve (not shown). Capsule variations will be described in detail in a later section. 
         [0056]    With reference to  FIG. 7 , the delivery catheter assembly  7  is generally comprised of a family of nested catheters concentrically and slidably disposed over one another. The innermost catheter in the family of nested catheters is the guidewire catheter  30  which has a distal section  32  that is coupled to the distal capsule  14 , and a proximal section  31 , with a guidewire lumen  33  that is generally sized to accept a guidewire running therebetween. The guidewire catheter  30  has a constant outer diameter and a constant inner diameter throughout its entire length, as well as a flexible section  300  which allows for articulation. The guidewire catheter  30  is generally configured to be able to fit inside of and translate slidably with respect to the bell catheter  34 . The bell catheter  34  has a distal section  360  that is coupled to a bell  36 , wherein the bell can be generally cylindrically shaped having a diameter larger than the bell catheter, and a proximal section  35 , with an inner lumen  361  that is generally sized to accept the guidewire catheter  30  running therebetween. The bell catheter  34  has a constant outer diameter and a constant inner diameter throughout its entire length, as well as a flexible section  301  which allows for articulation. The bell catheter  34  is generally configured to be able to fit inside of and slidably translate with respect to the anchoring catheter  37 . The anchoring catheter  37  has a distal section  39  that is coupled to an anchor  400 , wherein the anchor can be generally cylindrically shaped and have a plurality of anchoring slots circumferentially positioned to receive valve commissure anchoring portions (not shown), and a proximal section  38 , with an inner lumen  40  that is generally sized to accept the bell catheter  34  running therebetween. The anchoring catheter  37  has a constant outer diameter and a constant inner diameter throughout its entire length, as well as a flexible section  302  which allows for articulation. The anchoring catheter  37  is generally configured to be able to fit inside of and translate with respect to the sheath catheter  41 . The sheath catheter  41  has a distal section  43  that is coupled to the proximal capsule  13 , wherein the proximal capsule can have a cylindrical portion terminating in a cap portion, and wherein the cap portion can have a rounded dome-like surface, and a proximal section  42 , with an inner lumen  130  that is generally sized to accept the anchoring catheter  37  running therebetween. The sheath catheter  41  has a constant outer diameter and a constant inner diameter throughout its entire length, as well as a flexible section  303  which allows for articulation. The sheath catheter  41  is generally configured to be able to fit inside of and slidably translate with respect to the steering catheter assembly  6 . The steering catheter assembly  6  is comprised of a steerable catheter  309 , a pull ring  307 , wherein the pull ring can have a circular ring-like shape located at the distal section  305  of the catheter, a plurality of pull wires  308  located at the proximal section of the catheter, a flexible section  304  that allows for articulation, and an inner lumen  310  running throughout the entire length. For each pull wire  308  there is a corresponding lumen (not shown) that runs the entirety of the steerable catheter  309 . 
         [0057]    Generally, the steering guide  10  includes an interface section  9  that is comprised of an o-ring type interface of cylindrical shape similar to a gasket, which is embedded within A and B side steering handle housings  24  and  25  respectively, the A-side steering handle housing  24 , the B-side steering handle housing  25 , an actuator such as a steering thumbwheel  16 , wherein the steering thumbwheel can have a generally cylindrical shape, a catheter strain relief  27 , and a steerable catheter assembly  6 . The steering thumbwheel can additionally include one or more protrusions separated by one or more recesses or slots to provide a surface to facilitate grasping and turning the wheel. In some embodiments, the steering thumbwheel can have a textured surface with ribs to facilitate grasping and turning the wheel. The interface section  9  provides a dynamic seal between the steering handle  5  and the delivery catheter assembly  7  thus allowing for slidably sealed catheter translation thereby; the delivery catheter assembly thus may traverse therethrough and exit towards the distal end of the steering guide  10  at the terminal, articulated end  15  of the steerable catheter assembly  6 . While the interface section  9  provides a dynamic seal, the delivery catheter assembly  7  may still translate and rotate within the steering guide  10 , in order to define accurate positioning within a patient, at the target implant site. Detail regarding the implant procedure and target implant site will be discussed in a later section. In order to actuate the steerable portion of the steering catheter assembly  6 , the steering thumbwheel  16  must be turned. When the steering thumbwheel  16  is turned, the articulated end  15  of the steerable catheter assembly  6  will bend in the same direction as the direction of thumbwheel turning. This motion translation is achieved through the use of internal pull wires  308 , as depicted for example in  FIG. 7 , that are distally in mated connection (such as a welded connection, or using fasteners, or adhesives, or any suitable method of fastening) with a pull ring  307 , and proximally connectably communicate with the internal mechanisms which are inherent to the steering handle  5  and will be described in further detail in a later section. 
         [0058]    Turning now to  FIGS. 2A-2F , the sequence of steps generally followed during a trans-septal valve implantation are incorporated for reference.  FIG. 2A  describes a general depiction of a partial view (with anterior ventricular surface, pulmonary trunk, and aorta removed) of a human heart  800 . The steering guide  7  will follow a guidewire  811  that has previously been placed in order to provide a path that leads to the target implant site. During a typical procedure, the steering guide  7  will enter the inferior vena cava  810  by way of the descending inferior vena cava (not shown) and first an incision at the femoral vein near the groin (not shown). The steering guide  7  will then exit the inferior vena cava  810  through a caval foramen  801  which acts as an inlet to the right atrium  802  ( FIG. 2B ). Once in the right atrium  802 , the steering guide  10  will then penetrate the foramen ovale  803  in the septal wall and gain access to the left atrium  804 . At the left atrium  804  ( FIG. 2C ), the steering guide  10  will be aimed towards the mitral annulus  805  in order to provide a direct channel towards the implant site (mitral annulus  805 ) for the delivery catheter  812  ( FIG. 2D ) to operate within. Once at the target implant site ( FIG. 2E ), the delivery catheter  812  will operate to deploy the prosthetic valve  808 . Once the valve  808  has been deployed, the delivery catheter  812  can be fully removed ( FIG. 2F ). 
         [0059]    Again turning, now to  FIGS. 3A-3D , the sequence of steps generally followed during a trans-aortic valve implantation are incorporated for reference.  FIG. 3A  describes a general depiction of a partial view (with anterior ventricular surface, pulmonary trunk, and aortic root surface removed) of a human heart  800 . The steering guide  7  will again follow a guidewire  811  that has previously been placed in order to provide a path that leads to the target implant site. During a typical procedure, the steering guide  7  will enter the descending aorta  813  by way of an incision at the femoral artery near the groin (not shown). The steering guide  7  will then continue up the descending aorta  813  and cross the aortic arch  814  before passing through the aortic valve  815  and descending into the left ventricular outflow tract  816  (LVOT). After emerging from the LVOT  816 , and entering the left ventricle  817 , the steering guide  7  must then make a sharp turn and point upward and towards the mitral annulus  805 . At this point, the delivery catheter  812  may be advanced within the steering guide  7  in order to approach the target implant site (mitral annulus  805 ). Once at the target implant site ( FIG. 2E ), the delivery catheter  812  will operate to deploy the prosthetic valve  808 . Once the valve  808  has been deployed, the delivery catheter  812  can be fully removed ( FIG. 2F ). 
         [0060]    With particular reference to  FIGS. 4-7 , the internal mechanisms of the trans-septal delivery system  1  that permit functionality will be described. Specifically,  FIG. 4  illustrates an embodiment of an assembly of a trans-septal delivery system  1  shown in exploded view. The trans-septal delivery system  1  is displayed in sections in order to make description of the internal parts more easily understood. Delivery handle section  403  will be described in further detail below with reference to  FIG. 5 . Steering handle section  402  will be described in further detail below with reference to  FIG. 6 . Finally, delivery catheter section  401  has previously been described above with reference to  FIG. 7 . 
         [0061]    Referring now to  FIG. 5 , the delivery handle section  403  is generally comprised of an A-side delivery handle housing  22  that is in mating connection with a B-side delivery handle housing  23 , actuators such as a plurality of thumbwheels (distal thumbwheel  11  and proximal thumbwheel  12 ), a plurality of force transferring leadscrews (distal leadscrew  503  and proximal leadscrew  511 ) that may translate proximally or distally depending on the rotation of the thumbwheel within said plurality of thumbwheels, a plurality of hemostatic ports and related tubing (hemo port A  21 , hemo port B  20 , hemo port C  18  and hemo port D  19 ) which provide the ability to remove entrained air boluses from concentrically nested catheters within the system, and various other components and fasteners that shall be described in further detail. Referring specifically to the motion transferring elements of the delivery handle section  403 , a distal leadscrew  503  is in threaded connection with a distal thumbwheel  11  and by turning said distal thumbwheel  11 , translational motion is imparted upon the distal leadscrew  503 . The motion of the distal leadscrew  503  is transferred to the sheath catheter  41  by way of a connection between the proximal end  42  of the sheath catheter  41  and the distal end  5010  of the distal leadscrew cap  501 , which itself is mated with adhesive (medical grade UV cure adhesive, or medical grade cyanoacrylate adhesive, or any suitable medical grade adhesive for plastics or polymers, etc.) to the distal leadscrew  503 . The distal leadscrew cap  501  also permits the ejection of air by way of a sealed interface (distal o-ring  502 ) between the sheath catheter  41  and the anchoring catheter  37 , and an outlet hemo port A  21 . A stationary screw cap  504  is entrained within the A and B side handle housings  22 ,  23  respectively, and provides location and retention for the anchoring catheter  37 , whereby the proximal end  38  of the anchoring catheter  37  is in mated connection (medical grade UV cure adhesive, or medical grade cyanoacrylate adhesive, or any suitable medical grade adhesive for plastics or polymers, or by way of fastening mechanical threads) with the distal end  5040  of the stationary screw cap  504 . The stationary screw cap  504  also permits the ejection of air by way of a sealed interface (medial o-ring  505 ) between the anchoring catheter  37  and the bell catheter  34 , and an outlet hemo port B  20 . A proximal leadscrew  511  is in threaded connection with a proximal thumbwheel  12  and by turning said proximal thumbwheel  12 , translational motion is imparted upon the proximal leadscrew  511 . The motion of the proximal leadscrew  511  is transferred to the guidewire catheter  30  by way of a connection between the proximal end  31  of the guidewire catheter  30  and the distal end  5110  of the proximal leadscrew  511 . Proximal leadscrew  511  motion is also transferred to the bell catheter  34  by way of a slidable interference between the distal end  5110  of the proximal leadscrew  511  and the proximal leadscrew plate  510 , whereby the proximal leadscrew plate  510  is in mated connection with the proximal leadscrew cap  508 , and the proximal leadscrew cap  508  houses the proximal end  35  of the bell catheter  34 . The proximal leadscrew cap  508  also permits the ejection of air by way of a sealed interface (proximal o-ring  509 ) between the bell catheter  34  and the guidewire catheter  30 , and an outlet hemo port C  19 . The proximal leadscrew  511  permits the ejection of air by way of an outlet hemo port D  18  which is in mated connection with the proximal leadscrew  511 . 
         [0062]    Referring now to  FIG. 6 , the steering handle section  402  is generally comprised of an A-side steering handle housing  24  that is in mating connection with a B-side steering handle housing  25 , a steerable catheter assembly  6  that is in mating connection with a catheter strain relief  27 , an interface  9 , a plurality of rotatable disks (B-side rotatable disk  600  and A-side rotatable disk  607 ), a steering thumbwheel  16 , a push button  613 , and various other components and fasteners that shall be described in further detail. Referring specifically to the steering elements of the steering handle section  402 , a steering thumbwheel  16  is in mating connection with a locking hub  608  that is centered within the A-side rotatable disk  607 . The A-side rotatable disk  607  and B-side rotatable disk  600  are coupled together by way of a plurality of carrier rods  601 , and work mechanically to spin within the handle housing that is comprised of the A-side steering handle housing  24  and B-side steering handle housing  25 . Since the A-side rotatable disk  607  is connected to the steering thumbwheel  16 , rotation of the steering thumbwheel  16  causes rotation of the A-side rotatable disk  607 . A specific function of the plurality of rotatable disks (B-side rotatable disk  600  and A-side rotatable disk  607 ) is to actuate the plurality of pull wires  308  by way of tensioning hinges  602  that may spin freely on the carrier rods  601  and that are also connected to the pull wires  308  and also apply tension to them when turned. Referring now specifically to the locking elements of the steering handle section  402 , a push button  613  is in threaded connection with a push button pin  611  that acts as a shaft. The push button  613  is located within a cavity  6131  that allows for direct translation when the button is depressed. A push button spring  612  is housed between the inside surface of the push button  613 , and the bottom of the cavity  6131  and provides return force for when the depressed push button  613  is released. Motion from the push button  613  is transferred along the push button pin  611  directly to a cross bar  604  that is fastened to the push button pin  611  by way of a setscrew  605 . When the push button pin  611  translates as the push button  613  is depressed, the cross bar  604  also translates and a plurality of cross bar pegs  6041  that are located on the ends of the cross bar  604  thus translate as well. When in an un-depressed state, the cross bar pegs  6041  are seated within a plurality of slots  6071  that appear on the periphery of the A-side rotatable disk  607 . The cross bar pegs  6041  then also project through the slots  6071  and may rest within any of the circumferential slits  610  that appear in an array about the periphery of a position disk  609  that is mounted to the inside surface of the A-side steering handle housing  24  by threaded fasteners  606 . When in a depressed state, the cross bar pegs  6041  are moved away from the circumferential slits  610  until clearance is achieved, and the locking mechanism enables free rotation of the cross bar  604 , as well as all aspects that are directly connected to the A-side rotatable disk  607 . Further detail regarding the mechanics behind the locking mechanism can be seen in  FIG. 9 , which is incorporated herein for reference. 
         [0063]    By way of cross-sectional illustration,  FIGS. 8A-8D  show specific internal features of the devices described herein, and will now be relied upon to reveal further detail.  FIG. 8A  depicts the entire trans-septal delivery system  1  comprised of a distal end  3 , a steerable catheter assembly  6 , a steering handle  5 , and a delivery handle assembly  4  therebetween the distal end  3  and the proximal end  2 . At the distal end  3  of the trans-septal delivery system  1  is located the distal  14  and proximal  13  capsules, which entrain a prosthetic valve therein. An articulated end  15  of the steerable catheter assembly  6  is in mating connection with the distal-most portion of the steering handle  5 , which locates and controls it thereby. The steering thumbwheel  16  provides actuation control of the articulated end  15  of the steerable catheter assembly  6 . Continuing proximally, the delivery handle assembly  4  is depicted, which houses the distal  11  and proximal  12  thumbwheels, each being responsible for the translation of the proximal  13  and distal  14  capsules, respectively. A hemo port A  21  is provided and housed by the a-side delivery handle housing  22  and b-side delivery handle housing  23  (not shown). Further hemo ports B, C, and D ( 20 ,  19 , and  18  respectively) are also provided, the functions of which being described in greater detail in previous sections. 
         [0064]      FIG. 8B  introduces a cross-sectional view AA of the aforementioned depiction in  FIG. 8A , which reveals the internal mechanisms of the distal end  3 , the steering handle  5 , and the delivery handle assembly  4 . Cross-section AA of  FIG. 8B  shows the internal surfaces of the distal capsule  14 , and the proximal capsule  13 , as well as the articulated end  15  of the steerable catheter assembly  6 , all of whose mechanical interactions have been described previously above. Also depicted is an internal view of the steering handle  5 , and the delivery handle assembly  4  which displays the elements distal  11  and proximal  12  thumbwheels, and a-side delivery handle housing  22 . A detail section C  250  is provided, whereby the enlarged illustration of the contents of detail section C  250  appear in  FIG. 8C . 
         [0065]    As mentioned,  FIG. 8C  is the enlarged illustration of the contents of detail section C  250  of  FIG. 8B , and further detail of the internal features of the valve capsule assembly  8  are hereby provided. It can be seen that the distal capsule  14  is internally threaded at a threaded portion  460 , which provides mating means for a guidewire catheter threaded insert  490  that is embedded near the distal end  32  of the guidewire catheter  30 . Similarly, the bell  36  is internally threaded at a threaded portion  470 , which provides mating means for a bell catheter threaded insert  500  that is embedded near the distal end  360  of the bell catheter  34 . Similarly, the anchor  400  is internally threaded at a threaded portion  480 , which provides mating means for an anchoring catheter threaded insert  510  that is embedded near the distal end  39  of the anchoring catheter  37 . Further regarding the bell  36 , it can be seen that the bell  36  is shown in position and concentrically oriented to the distal most portion  450  of the anchor  400 , over which it may translate when actuated accordingly by the delivery handle assembly  4  (not shown). It should be apparent that the connected pair that is comprised of the distal capsule  14  and guidewire catheter  30  may move in tandem concentrically within the similarly connected pair that is comprised of the bell  36  and bell catheter  34 , which may also move in tandem concentrically within the similarly connected pair that is comprised of the anchor  400  and anchoring catheter  37  which are stationary, but inherently flexible by virtue of their construction. The proximal capsule  13  by way of attachment to the sheath catheter  41  also form a connected pair that may move in tandem concentrically over the previously discussed catheters. 
         [0066]      FIG. 8D  depicts the result of the cross-section B-B introduced in  FIG. 8A . As previously described, a plurality of handle housings, A-side  24  and B-side  25  are in mated connection and form the entirety of the housing which comprises the steering handle  5 . Within this cross-section B-B of  FIG. 8D  can also be seen a plurality of carrier rods  601  that matingly pin together the A-side  607  and B-side  600  rotatable disks. Also shown are the cross bar  604 , push-button pin  611 , and setscrew  605  that fasten said bar and said pin together in mating connection. The steering thumbwheel  16 , which houses the push button  613  and by extension the push button spring  612  is further revealed, additionally. 
         [0067]      FIGS. 9A-9C  illustrate the internal mechanics of the locking mechanism that is inherent to the steering handle  5  (of which these figures provide a cross-sectional view), and further illustrate the dynamic relationships between the components, and the manner in which they may be operated. Beginning with  FIG. 9A , the sequence of operation that comprises pushing a button, turning a knob, and then releasing the button while maintaining an achieved angular position by the button is set forth. Specifically,  FIG. 9A  depicts the depression (arrow indicating translation  700 ) of the push button  613  that is mounted within the steering thumbwheel  16  and biased internally by the opposing force of the push button spring  612 . As the push button  613  is matingly connected to the cross bar  604  by way of the push button pin  611  and the setscrew  605 , when the push button  613  is translated through depression, the cross bar  604  is also translated (arrows indicating translation  730 ) in the same direction as the push button  613 . Once the cross bar  604  is fully translated, a plurality of cross bar pegs  6041  described on the ends of the cross bar  604  become disengaged from circumferential slits  610  ( FIG. 9B ) that are provided by the position disk  609  ( FIG. 9B ). 
         [0068]    Continuing within  FIG. 9B , once the cross bar  604  is unconstrained it is thus free to rotate (arrows indicating rotation  740 ) by the application of a torque to the steering thumbwheel  16  (arrows indicating rotation  710 ). 
         [0069]      FIG. 9C  provides the final step in the operation of the push button  613  mechanism of the steering thumbwheel  16  for steering and positional lockout. After the appropriate rotational position is achieved with the steering thumbwheel  16 , the push button  613  is released. This allows for translation in the opposite direction (arrows indicating translation  720 ) to that experienced when the push button  613  is depressed, due to the biasing force of the push button spring  612 . Releasing the push button  613  also allows the cross bar  604  to translate (arrows indicating translation  750 ) and by extension, the cross bar pegs  6041  may thus achieve re-engagement with the circumferential slits  610  ( FIG. 9B ) and provide lockout against further rotation of the steering thumbwheel  16  and by extension disruption of position of the steerable catheter  309  (not shown). 
         [0070]    Turning now to  FIGS. 10A-10D , a sequence of images is provided which depict the rotation of the steering thumbwheel  16  and the ensuing effect at the valve capsule end of the system. Beginning with  FIG. 10A , when a torque is applied to the steering thumbwheel  16 , rotational motion is transferred to the A-side rotatable disk  607 , which is in communication with a plurality of pull wires  308  that are further internally embedded at the articulated end  15  of the steerable catheter assembly  6 . The pull wires act to preferentially pull the articulated end  15  of the steerable catheter assembly  6  in the direction of steering thumbwheel  16  rotation. Further application of torque ( FIG. 10B-10D ) results in a further rotation of the steering thumbwheel  16  and yet further bending of the articulated end  15  of the steerable catheter assembly  6 . 
         [0071]    Now with specific reference to  FIGS. 11A-11D , a particular embodiment of a valve capsule assembly  8 , and general deployment sequence of a trans-catheter valve prosthesis are herein illustrated. Details regarding the trans-catheter valve prosthetic referenced herein are described in commonly-owned U.S. Pat. No. 8,579,964 to Lane et. al. As depicted in  FIG. 11B , a trans-catheter valve prosthesis  1100  is entrained within the valve capsule assembly  8 , after having been preferentially crimped (details regarding the loading device used to crimp said trans-catheter valve prosthetic are described in commonly-owned U.S. Pat. Publication. No. 20/0155990, the entire contents of which are incorporated herein by reference, and loaded therein. The valve capsule assembly  8  can comprise a generally cylindrical structure having a proximal end and a distal end, wherein each of the proximal and distal ends terminates in a rounded dome-like surface. As shown in  FIG. 1 , the valve capsule assembly can comprise a proximal capsule  13  and a distal capsule  14 , wherein the proximal capsule  13  is disposed at a proximal end of the valve capsule assembly, and the distal capsule  14  is disposed at a distal end of the valve capsule assembly. Each of the proximal capsule  13  and the distal capsule  14  can have a cylindrical portion with one end of the cylindrical portion having an open circular shape and the other end having a cap portion that can have a rounded dome-like surface. As shown in  FIG. 3 , the open circular shape of proximal capsule  13  can be configured to meet with or abut against the open circular shape of distal capsule  14 , with the cap portion of the proximal capsule forming the proximal end of the valve capsule assembly, and the cap portion of the distal capsule forming the distal end of the valve capsule assembly. 
         [0072]      FIG. 11C  illustrates the valve  1100  in staged deployment after the proximal capsule  13  has been translated away from the valve  1100 , and the atrial skirt  1101  has been revealed and allowed to self-expand.  FIG. 11D  illustrates the valve  1100  with the atrial skirt  1101  fully expanded, after the distal capsule  14  has been translated away from the valve  1100 . A plurality of trigonal anchoring tabs  1102  have also been revealed by the movement of the distal capsule  14 .  FIG. 11E  illustrates final deployment of the valve  1100 , whereby the distal capsule  14  has translated to its maximum displacement, and the bell  36  on the bell catheter  34  has also translated maximally in order to release anchoring features of the valve (not shown) until finally full release of the valve from the delivery device has been achieved, and the valve  1100  is no longer anchored to any part of the valve capsule assembly  8 . 
         [0073]    With particular reference to  FIGS. 12A-12D , an alternative embodiment of a valve capsule assembly  1205  is herein illustrated.  FIG. 12A  depicts a valve capsule assembly  1205  which can be comprised of a proximal capsule  13 , a distal capsule sleeve  1200 , and an optional balloon tip  1201 or a tapered tip. The balloon tip  1201  may be preferentially inflated or deflated in order to optimize space constraints that are inherent to the anatomical limitations found within the left ventricle of the human heart, whereby deflating the balloon tip  1201  allows the distal capsule sleeve  1200  (which is generally configured to be shorter in overall length than the previously described proximal capsule  14 ,  FIG. 1 ) to translate over the balloon tip  1201  in order to enable typical deployment. 
         [0074]    With particular reference to  FIGS. 13A-13D , an alternative embodiment of a valve capsule assembly  1305  is herein illustrated.  FIG. 13A  depicts a valve capsule assembly  1305  which is comprised of a proximal capsule  13 , and a collapsible distal capsule  1300 . The collapsible distal capsule  1300  generally translates and functions in the manner of an accordion, in order to optimize space constraints that are inherent to the anatomical limitations found within the left ventricle of the human heart, whereby collapsing the distal capsule  1300  to enable typical deployment requires moving the body of the capsule into the left ventricle a shorter distance than that anticipated by the previously described proximal capsule  14  ( FIG. 1 ). The operational function of the collapsible distal capsule  1300  relies on the actuation of a plurality of stacked rings  1301  or stackable elements that can be joined in series and can generally covered by a shroud  1302  that may be comprised of fabrics, polymers, metallic alloys or any combination thereof. 
         [0075]    Any embodiment of a valve capsule assembly may be used in any delivery catheter as described herein. With particular reference to  FIGS. 14A-14D , an alternative embodiment of a valve capsule assembly  1405  is herein illustrated.  FIG. 14A  depicts a valve capsule assembly  1405  which is comprised of a proximal capsule  13 , and a collapsibly splined distal capsule  1400 . The collapsibly splined distal capsule  1400  generally translates and functions in the manner of an umbrella, in order to optimize space constraints that are inherent to the anatomical limitations found within the left ventricle of the human heart, whereby collapsing the splined distal capsule  1400  to enable typical deployment requires moving the body of the capsule into the left ventricle a shorter distance than that anticipated by the previously described proximal capsule  14  ( FIG. 1 ). The operational function of the collapsibly splined distal capsule  1400  relies on the actuation of plurality of hinged splines  1401  that are joined in parallel and generally covered by a shroud  1402  that may be comprised of fabrics, polymers, metallic alloys or any combination thereof. The splines  1401  can be arm-like parallel structures formed by a series of parallel cuts or incisions along a longitudinal surface of the cylindrical portion of the capsule, wherein the hinges of the splines allow each arm-like structure to bend, thus compressing or collapsing the distal capsule. 
         [0076]    With particular reference to  FIGS. 15A-15D , an alternative embodiment of a valve capsule assembly  1505  is herein illustrated.  FIG. 15A  depicts a valve capsule assembly  1505  which is comprised of a proximal capsule  13 , and a collapsibly wired distal capsule  1500 . The collapsibly wired distal capsule  1500  generally translates and functions in the manner of a flag pole (relying on the push/pull of the rigid plurality of wires  1502 ) in order to optimize space constraints that are inherent to the anatomical limitations found within the left ventricle of the human heart, whereby collapsing the wired distal capsule  1500  to enable typical deployment requires moving the body of the capsule into the left ventricle a shorter distance than that anticipated by the previously described proximal capsule  14  ( FIG. 1 ). The operational function of the collapsibly wired distal capsule  1500  relies on the actuation of plurality of nitinol or similar alloy wires  1502  that are joined in parallel and proximally fastened to a structural ring  1501  and generally covered by a shroud  1504  that may be comprised of fabrics, polymers, metallic alloys or any combination thereof. Distally, the plurality of nitinol wires  1502  may be withdrawn into a plurality of distal slots  1506 , and then finally a distal lumen  1507  (not shown) that resides inside of a distal cap  1503  in order to cinch the capsule in its entirety, and translate it away from the distal portion of the valve. In one particular embodiment, the distal lumen  1507  (not shown) would comprise an additional lumen (not shown) appearing within the guidewire catheter ( 30 ,  FIG. 7 ) the additional lumen (not shown) traversing the entire delivery system and exiting through the delivery system A and B side handle halves  22 ,  23  respectively. The plurality of nitinol wires  1502  would traverse and exit the additional lumen (not shown), and be graspable and pullable for deployment, by an operator. 
         [0077]    With particular reference to  FIGS. 16A-16D , an alternative embodiment of a valve capsule assembly  1605  is herein illustrated.  FIG. 16A  depicts a valve capsule assembly  1605  which is comprised of a proximal capsule  13 , and a shape memory distal capsule  1600 . The shape memory distal capsule  1600  generally translates and functions in the manner of an accordion, in order to optimize space constraints that are inherent to the anatomical limitations found within the left ventricle of the human heart, whereby collapsing the shape memory distal capsule  1600  to enable typical deployment requires moving the body of the capsule into the left ventricle a shorter distance than that anticipated by the previously described proximal capsule  14  ( FIG. 1 ). The operational function of the shape memory distal capsule  1600  relies on the actuation and stiffening of a stent-like nitinol or similar alloy frame  1600  by the temperature gradient within a patient&#39;s blood stream, that is further anchored to a structural cap  1601  and generally covered by a shroud  1601  that may be comprised of fabrics, polymers, metallic alloys or any combination thereof. A plurality of internal biasing wires  1603  enable the shape memory distal capsule  1600  to be collapsed when they are in tension, and to be extended when they are not in tension. 
         [0078]    Prosthesis 
         [0079]      FIG. 17A  illustrates a perspective view of a preferred embodiment of a prosthetic mitral valve with optional coverings removed to allow visibility of the anchor struts.  FIG. 17B  illustrates a top view of the prosthetic valve in  FIG. 17A  from the atrium looking down into the ventricle. The valve  1700  includes an asymmetrical expanded anchor portion having a D-shaped cross-section. As shown, the anchor portion generally comprises anterior  1702  and posterior  1704  aspects along the longitudinal axis thereof, as well as atrial  1706 , annular  1708  and ventricular  1710  regions. Commissures (also referred to herein as commissure posts)  1713  are also shown. The prosthetic valve  1700  has a collapsed configuration and an expanded configuration. The collapsed configuration is adapted to loading on a shaft such as a delivery catheter for transluminal delivery to the heart, or on a shaft for transapical delivery through the heart wall. The radially expanded configuration is adapted to anchor the valve to the patient&#39;s native heart adjacent the damaged valve. In order to allow the valve to expand from the collapsed configuration to the expanded configuration, the anchor portion of the valve may be fabricated from a self-expanding material such as a nickel titanium alloy like nitinol, or it may also be made from spring temper stainless steel, or a resilient polymer. In still other embodiments, the anchor may be expandable with an expandable member such as a balloon. In preferred embodiments, the anchor is fabricated by laser cutting, electrical discharge machining (EDM), or photochemically etching a tube. The anchor may also be fabricated by photochemically etching a flat sheet of material which is then rolled up with the opposing ends welded together. 
         [0080]    The atrial skirt portion  1716  forms a flanged region that helps to anchor the prosthetic valve to the atrium, above the mitral valve. The atrial skirt includes a plurality of triangular fingers which extend radially outward from the anchor to form the flange. The posterior  1704  portion of the atrial skirt  1716  is generally round or circular, while a portion of the anterior  1702  part of the atrial skirt  1716  is flat. Thus, the atrial skirt region preferably has a D-shaped cross-section. This allows the prosthetic valve to conform to the patient&#39;s cardiac anatomy without obstructing other portions of the heart, as will be discussed below. Each triangular finger is formed from a pair of interconnected struts. The triangular fingers of the atrial skirt generally are bent radially outward from the central axis of the prosthetic valve and lie in a plane that is transverse to the valve central axis. In some embodiments, the atrial skirt lies in a plane that is substantially perpendicular to the central axis of the valve. The anterior portion  1702  of the atrial skirt  1706  optionally includes an alignment element  1714  which may be one or more struts which extend vertically upward and substantially parallel to the prosthetic valve. The alignment element  1714  may include radiopaque markers (not illustrated) to facilitate visualization under fluoroscopy. The alignment element helps the physician to align the prosthetic valve with the native mitral valve anatomy, as will be discussed later. 
         [0081]    Disposed under the atrial skirt region is the annular region  1720  which also has a collapsed configuration for delivery, and an expanded configuration for anchoring the prosthetic valve along the native valve annulus. The annular region is also comprised of a plurality of interconnected struts that form a series of cells, preferably closed. Suture holes  1721  in some of the struts allow tissue or other coverings (not illustrated) to be attached to the annular region. Covering all or a portion of the anchor with tissue or another covering helps seal the anchor against the heart valve and adjacent tissue, thereby ensuring that blood is funneled through the valve, and not around it. The annular region may be cylindrical, but in preferred embodiments has a posterior portion  1704  which is circular, and an anterior portion  1702  which is flat, thereby forming a D-shaped cross-section. This D-shaped cross-section conforms better to the native mitral valve anatomy without obstructing blood flow in other areas of the heart. 
         [0082]    The lower portion of the prosthetic valve includes the ventricular skirt region  1728 . The ventricular skirt region also has a collapsed configuration for delivery, and an expanded configuration for anchoring. It is formed from a plurality of interconnected struts that form a series of cells, preferably closed, that can radially expand. The ventricular skirt in the expanded configuration anchors the prosthetic valve to the ventricle by expanding against the native mitral valve leaflets. Optional barbs  1723  in the ventricular skirt may be used to further help anchor the prosthetic valve into the ventricular tissue. Barbs may optionally also be included in the atrial skirt portion as well as the annular region of the anchor. Additionally, optional suture holes  1721  in the ventricular skirt may be used to help suture tissue or another material to the ventricular skirt region, similarly as discussed above. The anterior  1702  portion of the ventricular skirt may be flat, and the posterior  1704  portion of the ventricular skirt may be circular, similarly forming a D-shaped cross-section to anchor and conform to the native anatomy without obstructing other portions of the heart. Also, the lower portions of the ventricular skirt serve as deployment control regions since the lower portions can remain sheathed thereby constraining the ventricular skirt from radial expansion until after the optional ventricular trigonal tabs and posterior tab have expanded, as will be explained in greater detail below. 
         [0083]    The ventricular skirt portion may optionally also include a pair of ventricular trigonal tabs  1724  on the anterior portion of the anchor (only  1  visible in this view) for helping to anchor the prosthetic valve as will be discussed in greater detail below. The ventricular skirt may also optionally include a posterior tab  1726  on a posterior portion  1704  of the ventricular skirt for anchoring the prosthetic valve to a posterior portion of the annulus. The trigonal tabs  1724  or the posterior tab  1726  are tabs that extend radially outward from the anchor, and they are inclined upward in the upstream direction. 
         [0084]    The actual valve mechanism is formed from three commissures posts (also referred to as commissures)  1713  which extend radially inward toward the central axis of the anchor in a funnel or cone-like shape. The commissures  1713  are formed from a plurality of interconnected struts that create the triangular shaped commissures. The struts of the commissures may include one or more suture holes  1721  that allow tissue or a synthetic material to be attached to the commissures. In this exemplary embodiment, the valve is a tricuspid valve, therefore it includes three commissures  1713 . The tips of the commissures may include a commissure tab  1712  (also referred to as a tab) for engaging a delivery catheter. In this embodiment, the tabs have enlarged head regions connected to a narrower neck, forming a mushroom-like shape. The commissures may be biased in any position, but preferably angle inward slightly toward the central axis of the prosthetic valve so that retrograde blood flow forces the commissures into apposition with one another to close the valve, and antegrade blood flow pushes the commissures radially outward, to fully open the valve.  FIG. 17B  is a top view illustrating the prosthetic valve of  FIG. 17A  from the atrial side, and shows the preferred D-shaped cross-section. 
         [0085]      FIG. 18A  illustrates the prosthetic mitral valve of  FIGS. 17A-17B  with a covering  1770  coupled to portions of the anchor with suture  1772 . This view is taken from an atrial perspective. In this embodiment, the covering is preferably pericardium which may come from a number of sources as disclosed elsewhere in this specification. In alternative embodiments, the covering may be a polymer such as Dacron polyester, ePTFE, or another synthetic material. The covering is preferably disposed over the annular region  1720  and the ventricular skirt region  1728 , and in some embodiments the anterior ventricular trigonal  1724  tabs and the ventricular posterior tab  1730  may also be covered with the same or a different material. The covering helps seal the anchor against the adjacent tissue so that blood funnels through the valve mechanism. In this embodiment, the atrial skirt is left uncovered, as well as tabs  1724 ,  1730 . Additionally, radiopaque markers  1714   a  form a portion of the alignment element and facilitate visualization of the prosthetic valve under fluoroscopy which is important during alignment of the valve. 
         [0086]      FIG. 18B  is a perspective view of the prosthetic mitral valve seen in  FIG. 18A , as seen from the ventricle. The struts of the valve commissures are covered with the same material or a different material as the annular and ventricular regions as discussed above, thereby forming the tricuspid valve leaflets  1713 .  FIG. 18B  shows the valve in the closed configuration where the three leaflets are engaged with one another preventing retrograde blood flow. Commissure tabs  1712  remain uncovered and allow the commissures to be coupled with a delivery device as will be explained below. The prosthetic valve in  FIGS. 18A-18B  may be sterilized so they are suitable for implantation in a patient using methods known in the art. 
         [0087]    While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. For example, any capsule may be used in any delivery catheter, delivery system, or method of delivering a prosthesis as disclosed herein. Similarly, any prosthesis or prosthetic valve may be used with any delivery catheter, delivery system, or method of delivering a prosthesis as disclosed herein. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.