Patent Publication Number: US-2020276013-A1

Title: Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/874,376, filed Jan. 18, 2018 and entitled SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES and also claims the benefit of U.S. Provisional Ser. No. 62/448,036, filed Jan. 19, 2017 and entitled SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES, the entirety of which is hereby incorporated by reference. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     INCORPORATION BY REFERENCE 
     All references, including but not limited to publications, patent applications and patents mentioned in this specification are hereby incorporated by reference to the same extent and with the same effect as if each reference was specifically and individually indicated to be incorporated by reference. 
     FIELD OF THE INVENTION 
     The inventions described herein relate to delivery systems, devices and methods for delivering and/or positioning a cardiac valve. 
     BACKGROUND OF THE INVENTION 
     The human heart comprises four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium and left ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. 
     The mitral valve is located between the left atrium and left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in arteries flowing blood away from the heart. The valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by reverse blood to prevent backflow (retrograde) of the blood into the chamber it just flowed out of. 
     Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to disease, trauma, congenital malformations, and aging. These types of conditions may cause the valve structure to either fail to properly open (stenotic failure) and/or fail to close properly (regurgitant). 
     Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve. Mitral regurgitation results from the mitral valve allowing at least some retrograde blood flow back into the left atrium from the right atrium. This backflow of blood places a burden on the left ventricle with a volume load that may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, that vary considerably during the prolonged clinical course of mitral regurgitation. 
     Native heart valves generally, e.g., mitral valves, therefore, may require functional repair and/or assistance, including a partial or complete replacement. Such intervention may take several forms including open heart surgery and open heart implantation of a replacement heart valve. See e.g., U.S. Pat. No. 4,106,129 (Carpentier), for a procedure that is highly invasive, fraught with patient risks, and requiring not only an extended hospitalization but also a highly painful recovery period. 
     Less invasive methods and devices for replacing a dysfunctional heart valve are also known and involve percutaneous access and catheter-facilitated delivery of the replacement valve. Most of these solutions involve a replacement heart valve attached to a structural support such as a stent, commonly known in the art, or other form of wire network designed to expand upon release from a delivery catheter. See, e.g., U.S. Pat. No. 3,657,744 (Ersek); U.S. Pat. No. 5,411,552 (Andersen). The self-expansion variants of the supporting stent assist in positioning the valve, and holding the expanded device in position, within the subject heart chamber or vessel. This self-expanded form also presents problems when, as is often the case, the device is not properly positioned in the first positioning attempt and, therefore, must be recaptured and positionally adjusted. This recapturing process in the case of a fully, or even partially, expanded device requires re-collapsing the device to a point that allows the operator to retract the collapsed device back into a delivery sheath or catheter, adjust the inbound position for the device and then re-expand to the proper position by redeploying the positionally adjusted device distally out of the delivery sheath or catheter. Collapsing the already expanded device is difficult because the expanded stent or wire network is generally designed to achieve the expanded state which also resists contractive or collapsing forces. 
     Besides the open heart surgical approach discussed above, gaining access to the valve of interest is achieved percutaneously via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques. 
     Generally, the art is focused on systems and methods that, using one of the above-described known access routes, allow a partial delivery of the collapsed valve device, wherein one end of the device is released from a delivery sheath or catheter and expanded for an initial positioning followed by full release and expansion when proper positioning is achieved. See, e.g., U.S. Pat. No. 8,852,271 (Murray, III); U.S. Pat. No. 8,747,459 (Nguyen); U.S. Pat. No. 8,814,931 (Wang); U.S. Pat. No. 9,402,720 (Richter); U.S. Pat. No. 8,986,372 (Murray, III); and U.S. Pat. No. 9,277,991 (Salahieh); and U.S. Pat. Pub. Nos. 2015/0272731 (Racchini); and 2016/0235531 (Ciobanu). 
     However, known delivery systems, devices and methods still suffer from significant flaws in delivery methodology including, inter alia, positioning and recapture capability and efficiency. 
     In addition, known “replacement” heart valves are intended for full replacement of the native heart valve. Therefore, these replacement heart valves physically engage the annular throat and/or valve leaflets, thereby eliminating all remaining functionality of the native valve and making the patient completely reliant on the replacement valve. Generally speaking, it is a preferred solution that maintains and/or retains the native function of a heart valve, thus supplementation of the valve is preferred rather than full replacement. Obviously, there will be cases when native valve has either lost virtually complete functionality before the interventional implantation procedure, or the native valve continues to lose functionality after the implantation procedure. The preferred solution is delivery and implantation of a valve device that will function both as a supplementary functional valve as well as be fully capable of replacing the native function of a valve that has lost most or all of its functionality. However, the inventive solutions described infra will apply generally to all types and forms of heart valve devices, unless otherwise specified. 
     Finally, known solutions for, e.g., the mitral valve replacement systems, devices and methods require 2-chamber solutions, i.e., there is involvement and engagement of the implanted replacement valve device in the left atrium and the left ventricle. Generally, these solutions include a radially expanding stent in the left atrium, with anchoring or tethering (disposed downward through the annular through) connected from the stent device down through the annular throat, with the sub-annular surface within the left ventricle, the left ventricular chordae tendineae and even into the left ventricle wall surface(s). 
     Such 2-chamber solutions are unnecessary bulky and therefore more difficult to deliver and to position/recapture/reposition from a strictly structural perspective. Further, the 2-chamber solutions present difficulties in terms of making the ventricular anchoring and/or tethering connections required to hold position. Moreover, these solutions interfere with the native valve functionality as described above because the device portions that are disposed within the left ventricle must be routed through the annulus, annular throat and native mitral valve, thereby disrupting any remaining coaptation capability of the native leaflets. In addition, the 2-chamber solutions generally require an invasive anchoring of some of the native tissue, resulting in unnecessary trauma and potential complication. 
     It will be further recognized that the 2-chamber mitral valve solutions require sub-annular and/or ventricular engagement with anchors, tethers and the like precisely because the atrial portion of the device fails to adequately anchor itself to the atrial chamber and/or upper portion of the annulus. Again, the inventive solutions described herein are readily applicable to single or 2-chamber solutions, unless otherwise indicated. 
     Various embodiments of the several inventions disclosed herein address these, inter alia, issues. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 2A  illustrates a side view of one embodiment of the present invention. 
         FIG. 2B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 3A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 3B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 4  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 5A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 5B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 6A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 6B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 6C  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 7A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 7B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 8A  illustrates a top view of one embodiment of the present invention. 
         FIG. 8B  illustrates a side and partially exploded view of one embodiment of the present invention. 
         FIG. 9A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 9B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 9C  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 9D  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 10A  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 10B  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 10C  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 11  illustrates a side cutaway view of one embodiment of the present invention. 
         FIG. 12  illustrates a side view of one embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Various embodiments of the present invention are disclosed in the Figures for providing percutaneous access to the valve of interest via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques. Each of these access routes may be used for the embodiments disclosed herein. 
     Thus,  FIG. 1  illustrates one embodiment of a prosthetic valve device  100  with a 2-part frame in collapsed configuration. The distal portion  102  of the collapsed device comprises the valve with prosthetic leaflets with a portion of the supporting frame, and is longitudinally translatably and rotatably confined within the lumen of an outer sheath  104  having a first outer diameter D. The proximal portion  106  of the collapsed device  100  comprises the remaining supporting frame which is in operative connection with the distal portion  102  of collapsed device  100  and in longitudinally translatably and rotatably confined within the lumen of an inner sheath  108  that is at least longitudinally translatable relative to the outer sheath  104  and wherein the outer sheath  104  is at least longitudinally translatable relative to the inner sheath  108 . The inner and/or outer sheath  108 ,  104  may also be rotationally translatable relative to the other sheath. The inner sheath  108  is disposed within the lumen of the outer sheath  104  and, therefore, the inner sheath  108  comprises a second outer diameter D′ that is smaller than the outer sheath&#39;s outer diameter D. 
     The preferred configuration of the device of  FIG. 1  comprises the collapsed device  100  consisting of one unit with a proximal and distal portion  106 , 102  as shown. The outer sheath  104  may be retracted to release expose firstly the distal portion  102  from the distal end  110  of the outer sheath  104  for initial expansion and positioning in the subject chamber of the heart. Alternatively, the distal portion  102  of the device  100  may be pushed distally to be released from the distal end  110  of the outer sheath  104  in response to distal translation of the inner sheath  108 , e.g., or to a push rod pushing against the proximal portion  106  of the device  100 . In the case of a push rod, the proximal portion  106  will eventually be pushed distally out of the smaller lumen of the inner sheath  106  and into the larger lumen of the outer sheath  104  where an interim secondary expansion of the proximal portion  106  occurs, followed by the secondary positioning expansion when the proximal portion  106  is eventually released from the distal end  110  of the outer sheath  104 . 
     If expanded within the left atrium in connection with a prosthetic mitral valve, the lower portion of the distal portion  102  may be positioned against the upper surface of the annulus within the left atrium. 
     In this configuration, if the distal portion  102  is properly positioned and released/expanded, then the secondary release and expansion of the proximal portion  106  of the device  100  may be initiated and achieved according to the alternative methods described above in connection with the initial release and expansion of the distal portion  102 . The skilled artisan will recognize that once the initial positioning expansion of the distal portion  102  is accomplished, then the secondary positioning expansion of the proximal portion  106  will also be properly located and positioned. 
     The configuration of  FIG. 1 , in its various embodiments, enables delivery of a device  100  comprising a frame that may be slightly oversized for the chamber, e.g., atrial, dimensions through the two-step frame positioning expansion method. Some frames in collapsed form may be as much as  2   x  in longitudinal length than any chamber, e.g., atrial, dimension. Thus, the staged positioning expansion method is necessary for delivery. 
     Turning now to  FIGS. 2A and 2B  a prosthetic valve device  200  comprising a supporting stent frame, with prosthetic valve attached and/or supported therein, is provided wherein the design comprises two portions (distal  202  and proximal  206 , wherein the prosthetic valve with leaflets  205  is held/supported within the distal portion  202 ) with expanded diameters that are connected by a central portion  203  that has a smaller diameter than the expanded diameters of the two portions  202 ,  206 . As illustrated, the two portions  202 ,  206  comprise an undeformed and fully expanded spherical shape, though other shapes may be used as the skilled artisan will readily understand. Certain embodiments may comprise at least one of the proximal and distal portions  206 ,  202  having an expanded sizing that is slightly larger than the subject chamber&#39;s dimensions, e.g., the left atrial dimensions to allow expansion anchoring. Moreover, the aspect ratio of each of the two portions  206 ,  202  may vary. 
     As shown, the collapsed stent with valve is held within the lumen of a delivery sheath  204 , with a distal portion that holds or supports the device  200  therein being released from the end  210  of the delivery sheath  204  with subsequent positioning expansion of same within the subject chamber, e.g., the left atrium. When proper positioning is confirmed, the remaining central portion  203  (if not previously released along with the distal portion  202 ) and/or the proximal portion  206  may then be released and positionally expanded by methods described in connection with  FIG. 1 , including use of an inner sheath as described above and/or a push rod to translate the device  200  out of the distal end  210  of the outer delivery sheath  204 . As with  FIG. 1 , this embodiment comprises a two-step or staged delivery mechanism. Both  FIG. 1  and  FIG. 2A / 2 B sets of embodiments may comprise a coating or covering on the distal portion  202  while the proximal portion  206  may comprise an open frame formed from, e.g., stent cells. In the case of  FIG. 2A / 2 B, the central portion  202  may also comprise and open cell construction and uncovered. The dashed lines of  FIG. 2B  show an alternate embodiment wherein the expanded delivered portion  202  comprises a hinge point  212  to assist in orienting the prosthetic valve and leaflets within distal portion  202  downward toward the native valve. 
       FIGS. 3A, 3B, 3C, 5A and 5B  provide further disclosure of exemplary prosthetic valve devices with support means, e.g., stented and associated exemplary delivery methods. Thus  FIG. 3A  shows the collapsed device  300  in the lumen of a delivery sheath  304  in operative communication with a push/pull rod  308  actuated by the device operator that is capable of distally translating the collapsed device  300  as in  FIG. 3A  out of the distal end  310  of the delivery sheath  304  for positioning expansion and, conversely, pulling the expanded device  300  as shown in  FIG. 3B  back into the distal end  310  of the delivery sheath  304  if necessary. The push/pull rod  308  may also allow in certain embodiments the rotation of the collapsed device  300  within the lumen of the delivery sheath  310  to aid in positioning prior to release and expansion. Further, the operative communication of the push/pull rod  308  with the collapsed device  300  may comprise a screw or clip release mechanism  311  connected with the most proximal portion of the collapsed device  300 . The base or lower portion of the device  300  may be covered with tissue or other biocompatible material while the upper portion of the device may comprise an open cell construction. 
     Generally, the collapsed device  300  is loaded and positioned within the delivery sheath  304  with the valve portion  305  oriented in a downward position as shown. This allows the collapsed valve device  305  to be pushed out of the delivery sheath  304  in a sideways orientation as illustrated and enables the expanding valve device  300  upon release from the delivery sheath to be properly oriented to the native valve and subject chamber, e.g., mitral valve and left atrium. 
     In certain cases, an alignment wire  315  may be translated from the delivery sheath  304  into a pulmonary vein, e.g., the left upper pulmonary vein PV to assist in positioning and delivery of the device  300 . 
       FIG. 4  illustrates a sideways delivery of device  300  during expansion and just after delivery from the outer end  310  of the delivery sheath  304 , wherein the delivered device is oriented substantially vertically and aligned for positioning over the native valve. 
     Thus, as shown best in  FIGS. 5A and 5B , the prosthetic valve device  500  may be delivered sideways (with the valve portion  505  oriented on the bottom as shown), asymmetrically and may comprise a locating element  515  in operative connection with the prosthetic valve device  500  and that extends from the delivery sheath  503  with at least a distal end of the locating element  515  or push tube disposed within a pulmonary vein PV, e.g., the left upper pulmonary vein as shown. This system provides a self-centering system that may expand upon releasing/translating the collapsed prosthetic valve device  500  from the distal end  510  of the delivery sheath  504 . As shown a push tube  508  and associated connector  511  may be used to assist in manipulating the orientation of the prosthetic valve device  500  once it is delivered from the distal end  510  of the delivery sheath  504 . 
     Turning now to  FIGS. 6A-6C , a the prosthetic valve device  600  is delivered using a delivery catheter or sheath  604  comprises either a pre-curved distal portion  620  or a distal portion adapted to be able to be curved  620  to present a substantially straight distal section within the atrium.  FIG. 6A  provides a pre-curved embodiment, curved to enable loading of a prosthetic valve device  600  in a configuration that places the valved bottom portion  605  in the proper location on release from the distal end  610  of the pre-curved distal portion  620  of the delivery catheter or sheath, more specifically from the straightened distal section distal to the pre-curved distal portion  620 . Thus, as shown, the valve supported portion  605  of the collapsed and expandable frame/stent is distal-most within the lumen of the delivery catheter/sheath  604 . The pre-curved portion  620  enables easy orienting of the valved portion  605  with an exemplary mitral valve and/or upper surface of the annulus thereof. 
     Thus, the delivery system with a curved distal portion as in  FIG. 6A  enables the prosthetic valve device  600  to be positioned over the annulus and native valve leaflets. When positioned over the annulus and native valve leaflets, the curved delivery catheter or sheath  604  may be withdrawn proximally, alone or in combination with a push rod  608  or similar device on the proximal side of the prosthetic valve device  600 , to release and deliver the prosthetic valve device  600  into the left atrium and expand the delivered device  600 . It is noteworthy that the curved delivery catheter or sheath  604  comprises in some embodiments a straight distal end within the left atrium and located distal to the curved section  620  wherein the compressed prosthetic valve device  600  is translated and manipulated around the curved portion  620  of the curved delivery catheter or sheath  604 . The compressed prosthetic valve device  600  may be assisted in translating around the curved portion  620  of the curved delivery catheter or sheath by including a suture attachment to the distal end of the implant, a pull wire attached to the distal end of the implant extending to the proximal end of the delivery catheter or sheath, or by taking advantage of the natural flexion point in the arrangement of  FIG. 1  between the proximal and the distal portions of the prosthetic valve device and/or by a hinging point as in  FIG. 2 . 
       FIGS. 6B and 6C  comprise an alternative approach to creating the curved portion  620  by enabling curving of the distal portion of the delivery sheath or catheter  604  by providing a series of cuts or serrations  609  along a bottom portion surface of the sheath or catheter, resulting in a weak region susceptible to bending. As shown a pull wire  625  is attached to the distal end  610  of the catheter  604  along this bottom weak cut or serrated region and is disposed through the catheter/sheath lumen to an operator who may pull the wire with force F proximally to achieve the desired curvature prior to release of the collapsed prosthetic valve structure  600  which is oriented in collapsed form as in  FIG. 6A  and released for positioning expansion virtually directly on the subject valve or upper annular surface. The cuts  609  may extend through the catheter/sheath wall completely or may only be sections that have a catheter/sheath wall that is thinner than the rest of the catheter/sheath walls. The cuts  609  shown are uniform and generally square, though any depth, shape and uniform or non-uniform spacing of same may be used to achieve the weakened region. 
       FIGS. 7A and 7B  illustrate delivery systems for an exemplary prosthetic valve, e.g., mitral valve replacement or supplement, to a heart chamber, e.g., the left atrium using a delivery catheter or sheath  704  as shown in  FIG. 7A  with transseptal access and in combination with an additional guidance tool  728  used to help guide the expanding valved device (not shown) as it is released from the distal end  710  of the catheter or sheath  704  using methods or devices described herein. The additional guidance tool  728  may be disposed within the upper pulmonary vein PV, for example. The guidance tool  728  may be hingedly or rotatingly attached to the catheter or sheath  704  enabling the tool  728  to rotate into position. A pull wire similar to that shown in  FIGS. 6B and 6C  may be used to connect to and manipulate the tool  728  into position. 
       FIG. 7B  illustrates two delivery systems, a first delivery system  800  for alignment and deployment and a second delivery system  850  for recapture and repositioning if needed. One of the delivery systems, either the first  800  or the second  850 , may access the subject heart chamber via a transfemoral access method while the other delivery system may access the subject heart chamber via another transvenous access method. The first delivery system  800  may thus comprise a delivery catheter or sheath  804  as described elsewhere herein while the second delivery system may comprise a recapture and repositioning catheter or sheath  854 , similar in structure to the delivery catheter/sheath  804 . 
       FIGS. 8A and 8B  illustrate embodiments designed to facilitate accurate positioning of a prosthetic heart valve within a chamber, e.g., the left atrium, including but not limited to self-centering and fluoroscopy techniques. In this embodiment of a prosthetic stented valve device  900 , with the prosthetic valve and leaflets  905  supported proximate the bottom portion of the valve device, the upper portion  909  of the device  900  may be divided into subsections as shown from the top in  FIG. 8A . The illustrated case provides 4 subsections, though other numbers of subsections may certainly be useful and are within the scope of the present invention. As shown, opposing subsections are either open cell or open wire construction  907  or are comprised of a fabric in the form of a type of sail  908 . Upon delivery of this device  900  to a subject heart chamber, the fabric sails  908  will catch and use the natural force of blood flow to maneuver the device frame  900  into proper positioning with subsequent release and expansion when positioning is confirmed. 
       FIG. 8B  is a related concept, but also includes an annulus spacer  919  that may be delivered first via a delivery catheter/sheath as described previously herein and in certain embodiments, the spacer may be directed into position with a guidewire positioned within the lumen of the delivery catheter/sheath and further moved out of the distal end of the delivery catheter/sheath and either proximate to (on the proximal side) of the chamber upper annular surface or may be disposed at least partway within the annular throat. Once released from the lumen and distal end of the delivery catheter/sheath, the annular spacer  919  may expand from a delivered collapsed form and positioned on the upper annular surface which may space the prosthetic valve and leaflets  905  from the upper annular surface. Subsequently, the prosthetic valve device, as described herein and which may, or may not, comprise sails  908  as in  FIG. 7A , is delivered from the delivery catheter/sheath and positionally expanded to connect with the previously positioned spacer  919 . 
     We next describe positional orienting delivery structures in  FIGS. 9A-9D . Generally, each of these prosthetic valved devices are designed for use in the left atrium and make use of the left atrial appendage (LAA) as an orienting mechanism.  FIG. 9A  therefore comprises an LAA plug  1006  disposed on a side surface of the collapsed device  100  within the delivery sheath  1004  lumen and, in  FIG. 9B , the LAA plug  1006  is positioned at least partially within the LAA. Once the LAA is engaged by the LAA plug  1006 , the operator has confirmation that the valved prosthetic device  1000  is in correct position. This device may be used in combination with any of the previously described devices and methods, including but not limited to the staged 2-step delivery devices and methods, whereby an initial positioning expansion would result in orienting the LAA plug into the LAA, then the secondary positioning expansion of the rest of the device initiated by release from the distal end of a delivery sheath. 
     An additional benefit of certain embodiments of  FIGS. 9A and 9B  may be to employ the LAA plug  1006  as a device to prevent clotting within the LAA, wherein the LAA plug  1006  fills the LAA entirely and/or an outer flange  1008  covers the LAA opening entirely to prevent any blood clots from forming and/or moving out of the heart to potentially cause a stroke. 
       FIG. 9D  shows a slightly different mechanism whereby a guidewire  1020  is disposed through a delivery sheath  1004  and into the LAA to provide orienting guidance for the positioning expansion (1 step or staged) of the collapsed prosthetic valved device (not shown) within the lumen of delivery sheath  1004 . The sheath  1004  may be pulled back to deploy/release the valved device (not shown) from the distal end of the sheath  1004  for positioning expansion or a push rod may be used to push the valved device out of the sheath&#39;s distal end as previously described. In these cases, the guidewire  1020  positioned within the LAA provides a key orienting guidance parameter so that the operator knows positioning will be proper on expansion. The guidewire  1020  may comprise an atraumatic tip to prevent damaging the tissue of the LAA. 
       FIG. 9C  illustrates another alignment/orienting system wherein the delivery catheter/sheath  1004  is introduced via a pulmonary vein PV, e.g., the upper pulmonary vein, into the left atrium and a guidewire  1020  disposed through the lumen of the delivery catheter/sheath  1004  and into, or proximate, the annulus, i.e., the annular throat, as a guide for the to-be-delivered valved device (not shown but compressed and self-expanding as previously described). When the sheath  1004  is pulled back, or a push rod is used to push the collapsed valved device out of the distal end of the delivery catheter or sheath  1004 , the expanding valved device may slide down over the pre-positioned guidewire  1020  to a proper position when fully expanded. 
       FIG. 10A  illustrates a partially expanded stented valved device  1100  released from the delivery catheter sheath. At least one capture wire  1030  (shown radially wrapped around the device  1100 , but may take other wrapping positions) is shown and which restrains the expandable device  1100  from fully expanding until properly positioned within the subject heart chamber, e.g., the left atrium. When proper position is confirmed, the capture wire  1030  may be removed by cutting and withdrawal distally through the delivery sheath  1004  lumen or by disconnecting a connector pin or latch  1032  or equivalent to enable full expansion of the device  1100  at the proper positional location.  FIG. 10B  is similar with an alignment wire  1130  that assists in positional orientation as it feeds out of the distal end of the delivery catheter/sheath  1104  while in connection with the partially expanding sheath at 2 or 3 or more stabilization points  1034  until proper position is confirmed. The stabilization point  1134  connections may hold the partially expanded device in that state until proper position is confirmed, then the connections may be removed, either by cutting (as in the case of a releasable suture) or by disconnecting a connector pin or latch, to enable the full expansion at the proper positional location or by provision of a secondary over the wire cutter introduced via the delivery catheter/sheath  1104  to clip alignment wire  1130 . 
       FIG. 10C  provides an alternative prosthetic heart valve device shown in a positionally expanded position after release from the distal end of the delivery catheter/sheath  1104  and comprising at least one attachment point  1032  located within the stented heart valve device as well as two or more pull/push wires  1130  with a first end connected to the at least one attachment point  1032  and a second end attached to points  1033  around the stent frame. This arrangement may function in several different ways to facilitate recapture, repositioning and/or redeployment. 
     First, one embodiment may comprise the two or more pull/push wires  1130  of a length that is slightly smaller than the chamber, e.g., left atriam, dimensions to ensure proper positioning. Once position is confirmed as proper, the pull/push wires  1130  may be released by, e.g., a secondary over the wire cutter or other means to disengage the pull/push wire connection between the at least one attachment point  1032  and the two or more pull/push wires  1130 , thereby enabling the full expansion of the properly positioned frame within the chamber. As with other embodiments described herein, the fully expanded frame may be slightly larger than at least one dimension to facilitate anchoring. 
     Another embodiment may further comprise a push rod disposed translationally within the delivery catheter/sheath  1104  lumen and that also provides a distally extending releasable connector attached to the at least one attachment point  1032  within the stented heart valve frame for disengaging the attachment between the at least one attachment point  1032  and the two or more push/pull wires  1130  once proper positioning is confirmed. This embodiment provides the further benefit of using a distally extending releasable connector tool to pull proximally on the at least one attachment point wherein the attachment point and the push/pull wires are connected to points on the stent frame that, when proximal force is applied to the attachment point, cause the stent frame to collapse slightly or fully, to enable repositioning. Once repositioned, distal force is applied to the releasable connector tool to fully expand the prosthetic valve frame. 
     Yet another embodiment may comprise the attachment point  1132 , push/pull wires  1130 , and/or the connection of the push/pull wires to the stent frame to be formed of a material that dissolves over a short time period. 
       FIG. 11  illustrates a prosthetic valve device  1200  comprising a ball and socket relationship between the support frame (socket or partial socket), with the prosthetic valve and leaflets  1253  disposed therein (ball or partial ball). In this embodiment, the outer frame  1250  is, as illustrated, a partial sphere having a radiusing and a central point  1252 , with the central point  1252  disposed generally around the native valve and annulus. The outer frame  1250  may comprise a radially extending flange  1254  to connect and seal with the upper annular surface and may further comprise wall elements  1256  extending upward from at least portions of the radially extending flange  1252  to connect with and seal against the chamber, e.g., left atrial, walls. The radially extending flange  1252  may comprise an expandable stent-like construction to provide radial expansive force to assist in anchoring the device  1200 . Alternative constructions may comprise any of the prosthetic stented valve frames described herein, e.g. and without limitation, an upper open expandable frame with a lower expandable frame covered with tissue. 
     The prosthetic valve further comprises an inner partial sphere  1253  with a radiusing that matches, or is complementary with, the radiusing of the outer frame&#39;s partial sphere  1250 , but with a smaller radius that the outer frame  1250  as the inner partial sphere  1253  resides within the outer frame&#39;s partial sphere  1250 . The prosthetic leaflets are supported within the inner partial sphere  1253 . The inner partial sphere  1253  may comprise a friction fit with the outer frame&#39;s partial sphere  1250  so that some movement is possible in all dimensions, including rotational, without losing the proper valve position relative to the native valve and/or annulus. Alternatives may allow a looser friction fit so that the inner partial sphere essentially floats within the outer frame&#39;s partial sphere, thereby allowing a fuller range of motion than a tighter friction fit. 
       FIG. 12  illustrates an implant frame with prosthetic valve device  1300  attached thereto connected via a connector element  1302  to a lasso structure  1304  that is, in turn, operatively connected with a manipulation wire  1306 , that may comprise a single wire or two wires, that extends proximally to the operator who is then able to manipulate the lasso  1304  and connector element  1302 . The lasso structure  1304  may comprise two distal wires, W 1 , W 2 , or more than two distal wires, in operative connection with the connector element  1302 . If the manipulation wire  1306  comprises two wires W 1 , W 2 , then a first of the two wires may be connected with wire  1  and the second of the two wires may be connected with wire  1 . Wires W 1 , W 2  may be disconnected from the connector element  1302  by the operator&#39;s pulling of one, or both, of the manipulation wire(s) W 1 , W 2 . The lasso structure  1304  may, as shown, be expandable to a diameter that is larger than the inner diameter of the catheter&#39;s  1305  lumen and is disposed through the implant frame structure with the connector element  1302  in operative connection with the lasso  1304  and the device frame  1300  generally in the middle of the implant structure. This configuration allows the operator to steer the device  1300  with the lasso structure  1304  during deployment and also allows retrieval back into the catheter&#39;s  1305  lumen if necessary. The connector element  1302  may be configured together with the device&#39;s  1300  frame structure to enable collapsing of the device&#39;s  1300  frame structure to allow pullback of the device&#39;s  1300  structure into the catheter&#39;s  1305  lumen. The connector element  1302  may also be disconnected by the operator from the device&#39;s  1300  frame, whereby one, or both, of the wires W 1 , W 2  are disconnected and the lasso structure  1304  retracted proximally through the catheter  1305 . In other embodiments, the connector element  1302  may remain attached to the device&#39;s  1300  frame structure when the operator disconnects wires W 1 , W 2  from the connector element  1302  and pulls the lasso structure  1304  proximally through the catheter sheath  1305 . 
     The description of the various inventions, embodiments thereof and applications as set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the contemplation of these inventions. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments would be understood to those of ordinary skill in the art upon study of this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the inventions.