Patent Publication Number: US-10327895-B2

Title: Pressure differential actuated prosthetic medical device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
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     STATEMENT REGARDING FEDERALLY SPONSORED R&amp;D 
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     NAMES OF PARTIES TO JOINT RESEARCH AGREEMENT 
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     REFERENCE TO SEQUENCE LISTING 
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     STATEMENT RE PRIOR DISCLOSURES 
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     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The invention relates to a medical prosthesis (Class 623), and in particular a heart valve substitute comprising a pliant tubular conduit (sub. 23.64) mounted on a resilient (sub. 2.14) annular frame (sub. 2.38) and tethered to a non-perforating anchor within the right or left ventricle of the heart, wherein the pliant tubular conduit is a reciprocating mechanical member (sub. 3.17) that is compressed by pressurized working fluid (sub. 3.20) within the ventricle during systole. 
     DESCRIPTION OF THE RELATED ART 
     In 1952 surgeons implanted the first mechanical heart valve. This first valve was a ball valve and it was designed by Dr. Charles Hufnagel. The recipient of this valve was a 30-year-old woman who could lead a normal life after the surgery. However, one downside of this design was that it could only be placed in the descending aorta instead of the heart itself. For this reason it did not fully correct the valve problem, only alleviate the symptoms. However it was a significant achievement because it proved that synthetic materials could be used to create heart valves. 
     In 1960, a new type of valve was invented and was successfully implanted. This valve is the Starr-Edwards ball valve, named after its originators. This valve was a modification of Hufnagel&#39;s original valve. The ball of the valve was slightly smaller and caged from both sides so it could be inserted into the heart itself. 
     The next development was tilting disc technology which was introduced in the late 1960s. These valves were a great improvement over the ball designs. The tilting dic technology allowed blood to flow in a more natural way while reducing damage to blood cells from mechanical forces. However, the struts of these valves tended to fracture from fatigue over time. As of 2003, more than 100,000 Omniscience and 300,000 Hall-Kaster/Medtronic-Hall tilting disc valves were implanted with essentially no mechanical failure. 
     In 1977, bi-leaflet heart valves were introduced by St. Jude. Similar to a native heart valve, blood flows directly through the center of the annulus of pyrolytic carbon valves mounted within nickel-titanium housing which makes these valves superior to other designs. However, a downside of this design is that it allows some regurgitation. A vast majority of mechanical heart valves used today have this design. As of 2003, more than 1.3 million St. Jude valves were deployed and over 500,000 Carbomedics valves with no failures to leaflets or housing. It should be noted that the human heart beats about 31 million times per year. 
     Development continues with compressible valves that are delivered via a catheter instead of requiring the trauma and complications of open heart surgery. This means that a cardiologist trained in endoscopy can, in theory, deploy a heart valve replacement during an outpatient procedure. However, transcatheter valves are often delivered by perforating the apex of the heart to access the ventricle, and the perforation is often used to anchor an annular valve replacement. Additionally, stent-style replacement valves often continue to have the regurgitation or leakage problems of prior generations of valves, as well as require expensive materials engineering in order to cope with the 100&#39;s of millions of cycles encountered during just a few years of normal heart function. Accordingly, there is still a need for alternative and simpler solutions to addressing valve-related heart pathologies. 
     BRIEF SUMMARY OF THE INVENTION 
     Accordingly, the present invention is directed to a medical prosthesis, and in particular a heart valve substitute comprising a pliant tubular conduit that is mounted on a resilient annular or sub-annular frame and that is tethered to a non-perforating anchor within the right or left ventricle of the heart, wherein the pliant tubular conduit is a reciprocating mechanical member that is compressed by pressurized working fluid, blood, within the ventricle during systole. Importantly, this heart valve substitute has no leaflets and does not have a traditional valve configuration. Additionally, the device can be delivered to the ventricle compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery. 
     The invention provides in one preferred embodiment a prosthetic medical device, comprising: (i) an elongated flexible cylinder defining a channel therein, said channel having a volume that ranges from 1.57 mL-18.84 mL, said cylinder having an average radius of 4.0-16.5 mm and an average height of 20-60 mm, said cylinder comprised of decellularized pericardium, said cylinder having top end, a bottom end, an internal surface, and an external surface, said cylinder is compressible under a pressure of 100-160 mm Hg on the external surface to close the channel, and said cylinder is expandable under a pressure of 40-80 mm Hg on the internal surface to open the channel; (ii) a one-piece, laser-cut, expandable nitinol top stent, said top stent attached to the top end of the cylinder, said top stent shaped as a conic frustum when expanded and defining a top stent channel therein, said conic frustum having a side wall, a top aperture, and a bottom aperture, said side wall having an average side length of 5-20 mm, said top aperture having an average expanded diameter of 30-35 mm, said bottom aperture having an average expanded diameter of 40-60 mm, said top stent having a cover, said cover connected with the cylinder wherein the channel of the cylinder is in communication with the top stent channel; and (iii) a one-piece, laser-cut, expandable nitinol bottom stent, said bottom stent having a top end, a bottom end, and a side wall, said top end of the bottom stent having from 2-5 tethers attached to the bottom end of the cylinder, said bottom stent having an average expanded diameter of 20-35 mm. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the cylinder is shaped as a conic cylinder, said top end having a diameter of 30-35 mm and said bottom end having a diameter of 8-20 mm. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the top stent cover is comprised of polyethylene terephthalate, decellularized pericardium, or a layered combination thereof. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the top end of the cylinder comprises, in order, a top edge connected to a top spacer segment that is connected to a top stent mounting segment, wherein the top edge has an collar mounted around the circumference of the top edge, said collar arranged as a flexible, semi-rigid, substantially flat panel or flat disk and having an average diameter of 30-60 mm, said collar having a nitinol frame covered with polyethylene terephthalate, decellularized pericardium, or a layered combination thereof, wherein the top spacer segment of the cylinder has a height from 5-20 mm, and wherein the top stent is mounted circumferentially around the top stent mounting segment of the cylinder. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the collar has one or more tissue anchors arranged along the circumference of the collar. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the nitinol frame of the collar supports a gel ring, wherein the gel ring is comprised of an expandable material enclosed within an outer sealing membrane, wherein the expandable material is a swellable powder within a polymeric matrix, a swellable polymeric matrix, or a swellable polymeric liquid. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the nitinol frame of the collar supports a deflatable ring, wherein the deflatable ring is comprised of a toroid-shaped sealed compartment having a valve, said sealed compartment fillable with a biocompatible liquid or gas, wherein upon removal of some or all of the biocompatible liquid or gas, the deflatable ring has a reduced diameter, and wherein upon removal of some or all of the biocompatible liquid or gas, the top spacer segment of the cylinder has a reduced height and the collar is compressed in the direction of the top stent. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the top stent has one or more tissue anchors arranged along the side wall of the top stent. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the bottom stent has one or more tissue anchors arranged along the side wall of the bottom stent. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the cylinder has an hourglass (hyperboloid) shape from top end to bottom end. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the bottom end of the cylinder is sealed, and wherein the cylinder has one or more perforations in a mid-segment side wall of the cylinder. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the top stent comprises a central stent hub with aperture and having a top circumferential flange and a bottom circumferential flange connected to the hub, with a top toroidal inflatable ring attached to the top circumferential flange and a bottom toroidal inflatable ring attached to the bottom circumferential flange. 
     In another preferred embodiment, there is provided a prosthetic medical device as described and claimed herein wherein the top stent comprises a threaded structure on an exterior surface of the stent, wherein the threaded structure allows for a simple circular screw-type deployment of the device into a native annulus to aid in sealing and sizing of the top stent into the native annulus. 
     In a preferred embodiment, there is also provided a method of controlling flow of bodily fluid within an enclosed cavity of a human body, said enclosed cavity having a reciprocating pressure differential, the method comprising the steps: (i) delivering the prosthetic medical device of claim  1  to the enclosed cavity within the human body; (ii) arranging the prosthetic medical device of claim  1  whereby the cylinder and cylinder channel are arranged parallel to a flow of fluid entering the enclosed cavity; (iii) expanding the top stent within an entrance to the enclosed cavity to mount the top end of the cylinder within the entrance, and whereby the side wall of the top stent applies an axial compression force and seals the entrance; (iv) expanding the bottom stent within the enclosed cavity to anchor the bottom end of the cylinder; wherein bodily fluid arriving at the enclosed cavity is diverted into the channel of the cylinder; wherein the reciprocating pressure differential comprises a low pressure state and a high pressure state; wherein bodily fluid flows into the channel to the enclosed cavity during the low pressure state, and wherein bodily fluid is prevented from flowing into the channel to the enclosed cavity during the high pressure state, wherein the high pressure state exerts a force on the external surface of the cylinder and collapses the reversibly collapses the channel. 
     In another preferred embodiment, there is provided a method as described and claimed herein further comprising the step of anchoring the prosthetic medical device of claim  1  to tissue within the enclosed cavity. 
     In another preferred embodiment, there is provided a medical prosthesis as claimed and described herein wherein the medical prosthesis is a heart valve substitute and comprises a pliant tubular conduit that is mounted on a resilient annular or sub-annular frame, the conduit is tethered to a non-perforating anchor for deployment within a right or left ventricle of a heart, wherein the pliant tubular conduit is a reciprocating mechanical member that is compressed by pressurized working fluid within the ventricle during a high pressure phase of the heart (systole). 
     In another preferred embodiment, there is provided a medical prosthesis as claimed and described herein wherein the medical prosthesis is a heart valve substitute comprising a pliant tubular conduit that is mounted on a resilient expandable passive assist cage, the cage is deployed within an atrial or ventricular chamber of a heart, wherein the pliant tubular conduit is a reciprocating mechanical member that is compressed by pressurized working fluid within the ventricle during a high pressure phase of the heart (systole). 
     In another preferred embodiment, there is provided a medical prosthesis as claimed and described herein wherein the cage defines an interior cavity and the conduit is mounted within the cavity. 
     In another preferred embodiment, there is provided a medical prosthesis as claimed and described herein wherein the cage defines an interior cavity and the conduit is mounted outside of the cavity. 
     In another preferred embodiment, there is provided a medical prosthesis as claimed and described herein wherein the medical prosthesis comprises a prosthetic valve that is mounted on a resilient expandable passive assist cage, the passive assist cage is deployed within an atrial or ventricular chamber of a heart, wherein the prosthetic valve is a reciprocating mechanical member that is closed by pressurized working fluid within the ventricle during a high pressure phase of the heart (systole) and opened by lower pressure working fluid within the ventricle during a low pressure phase of the heart (diastole). 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF DRAWING 
         FIG. 1  is an illustration of a cross-section of a heart showing a prosthetic medical device as described and claimed herein deployed in the right ventricle. 
         FIG. 2  is an illustration of a cross-section of a heart showing a prosthetic medical device as described and claimed herein deployed in the left ventricle. 
         FIG. 3  is a multi-feature illustration of a various sizes of unassembled top stents, cylinders, tethers, and bottom stents, and also showing a exemplary prosthetic medical device as described and claimed herein.  FIG. 3( a )-( d )  are illustrations of top stents,  FIG. 3( e )  is an illustration of a stent cover,  FIG. 3( f )-( l )  are illustrations of elongated flexible cylinders,  FIG. 3( m )-( n )  are illustrations of bottom stents,  FIG. 3( o )-( p )  are illustrations of tethers,  FIG. 3( q )  is a placement schematic for the right atrium and right ventricle and shows the channel axis, and  FIG. 3( r )  is an illustration of exemplary prosthetic medical device as described and claimed herein. 
         FIGS. 4( a ) and 4( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 4( a ) and ( b )  show a time sequence of a funnel-shaped intra-ventricular cylinder being compressed by systolic action of the right ventricle on the intraventricular blood. 
         FIGS. 5( a ) and 5( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 5( a ) and ( b )  show a time sequence of a conic-shaped intra-ventricular cylinder being compressed by systolic action of the right ventricle on the intraventricular blood. 
         FIGS. 6( a ) and 6( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 6( a ) and ( b )  show a time sequence of a funnel-shaped intra-ventricular cylinder being compressed by systolic action of the right ventricle on the intraventricular blood.  FIGS. 6( a ) and ( b )  also show an example of a device having a partial atrial collar. 
         FIGS. 7( a ) and 7( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a left atrium and left ventricle.  FIGS. 7( a ) and ( b )  show a time sequence of a conic-shaped intra-ventricular cylinder being compressed by systolic action of the left ventricle on the intraventricular blood.  FIGS. 7( a ) and 7( b )  also illustrate a device having a larger panel-shaped atrial collar. 
         FIG. 8  is a mid-height horizontal cross-sectional illustration of a heart and shows a top atrial view of a collared embodiment of the present invention having three wide-variety leaflet-collar anchors. 
         FIGS. 9( a ) and 9( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 9( a ) and ( b )  show a time sequence of an intra-ventricular cylinder being compressed by systolic action of the right ventricle on the intraventricular blood.  FIGS. 9( a ) and ( b )  also illustrate perivalvular leaflet anchors at the septal and anterior positions that extend from atrium to ventricle. 
         FIG. 10  is a mid-height horizontal cross-sectional illustration of a heart and shows a top atrial view of a collared embodiment of the present invention having a triangular aperture and nine medium-width variety leaflet-collar anchors. 
         FIGS. 11( a ) and 11( b )  are illustrations showing one embodiment of the present prosthetic medical device deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 11( a ) and ( b )  show a time sequence of a funnel-shaped intra-ventricular cylinder being compressed by systolic action of the right ventricle on the intra-ventricular blood.  FIGS. 11( a ) and ( b )  also illustrate perivalvular leaflet anchors at the septal and anterior positions that extend from atrium to ventricle. 
         FIG. 12  is a graphic representation of the change in right ventricular pressure from diastole to systole to diastole.  FIG. 12  shows the change in cross-sectional shape of the cylinder when a 2-, 3-, or 4-tether embodiment is deployed. 
         FIG. 13  is a graphic representation of the change in left ventricular pressure from diastole to systole to diastole.  FIG. 13  shows the change in cross-sectional shape of the cylinder when a 2-, 3-, or 4-tether embodiment is deployed. 
         FIGS. 14( a ) and 14( b )  are illustrations showing one embodiment of the present prosthetic medical device.  FIGS. 14( a ) and ( b )  show a time sequence of an intra-ventricular cylinder being compressed by hydro- or hemo-dynamic action of tissue that define a pressure cavity on the intracavity fluid.  FIGS. 14( a ) and ( b )  also illustrate a simple stent and cylinder device embodiment of the present invention having two tethers attached to tissue anchors. 
         FIG. 15( a )-( d )  is a multi-component view of an illustration of an hourglass-shaped, three-tether, cable-type top stent embodiment of the present invention.  FIG. 15( a )  shows an illustration of an entire device.  FIG. 15( b )  shows a cross-sectional view of just the top stent and cylinder along line C-C.  FIG. 15( c )  shows a bottom view along line B-B and shows how the cylinder collapses to a closed position.  FIG. 15( d )  shows a top view along line A-A looking down the interior of the channel. 
         FIG. 16( a )-( c )  is a multi-component view of an illustration of an hourglass-shaped, two-tether, cable-type top stent embodiment of the present invention.  FIG. 16( a )  shows an illustration of an entire device.  FIG. 16( b )  shows a bottom view along line B-B and shows how the cylinder collapses to a closed position.  FIG. 16( c )  shows a top view along line A-A looking down the interior of the channel. 
         FIG. 17  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar attached to an hourglass shaped cylinder that has a wide-aspect top stent mounted around the cylinder.  FIG. 17  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 18  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar with a large panel attached to an hourglass shaped cylinder that has a narrow-aspect top stent mounted around the cylinder.  FIG. 18  shows a two tether embodiment and a narrow-aspect bottom-stent style anchor. 
         FIG. 19  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar with a large panel attached to an hourglass shaped cylinder but does not have any top stent mounted around the cylinder.  FIG. 19  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 20  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar with a large panel attached to an hourglass shaped cylinder and has a covered-frame style top stent mounted around the cylinder.  FIG. 20  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 21  is an illustration of another embodiment of the present device and shows a vacuum-mounting feature whereby a cable-style (toroidal) collar is attached to an hourglass shaped cylinder that has a covered-frame style top stent mounted around the cylinder, but where the top stent has a covered nitinol frame that supports a deflatable ring, wherein the deflatable ring is comprised of a toroid-shaped sealed compartment having a valve, said sealed compartment fillable with a biocompatible liquid or gas, wherein upon removal of some or all of the biocompatible liquid or gas, the deflatable ring works in cooperation with the (non-moving) collar to compress the top spacer segment of the cylinder to a reduced height and thereby operate to seal and mount the device within a native annulus.  FIG. 21  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIGS. 22( a ) and 22( b )  are illustrations of another embodiment of the present device and shows in sequence an expansion-mounting feature whereby a compressed top-stent is attached to an hourglass shaped cylinder but whereby the top-stent and the bottom stent are comprised of a compressed material that is released, or of an inelastic deformable material, and thereby operate to seal and mount the device within a native annulus and native mount-area.  FIG. 22  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIGS. 23( a ) and 23( b )  are illustrations of another embodiment of the present device and shows in sequence an inflatable (or swellable)-mounting feature whereby a cable-style (toroidal) collar is attached to an hourglass shaped cylinder that has an uninflated or undeveloped top-stent attached to the hourglass shaped cylinder.  FIG. 23( b )  shows whereby the top-stent with polymer matrix absorbs liquid and expands, and thereby operates to seal and mount the device within a native annulus.  FIGS. 23( a ) and ( b )  show a two tether embodiment and, e.g. a tissue anchor. 
         FIGS. 24( a ) and 24( b )  are illustrations of another embodiment of the present device and show in sequence a thick walled cylinder being compressed by external pressure and closing the channel.  FIGS. 24( a ) and ( b )  show a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 25( a )-( c )  is an illustration of a multiple components on one embodiment of the present invention.  FIG. 25( a )  shows a cross-section of an open channel having two-tethers.  FIG. 25( b )  shows a cross-section of a compressed cylinder and closed channel having two tethers.  FIG. 25( c )  shows an embodiment of the prosthetic medical device having a top stent attached to a collapsible cylinder, the top stent having two contralateral annular anchors, and a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 26  shows an embodiment of the prosthetic medical device having a top stent attached to a conic cylinder, the top stent having two contralateral annular anchors, and a three tether embodiment with two tethers attached to a low-aspect bottom-stent style anchor, and one tether attached to a tissue anchor. 
         FIG. 27  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar attached to an hourglass shaped closed-bottom perforated cylinder (round perforations) that has a wide-aspect top stent mounted around the cylinder.  FIG. 27  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIG. 28  is an illustration of another embodiment of the present device and shows a cable-style (toroidal) collar attached to an hourglass shaped closed-bottom perforated cylinder (window-pane perforations) that has a wide-aspect top stent mounted around the cylinder.  FIG. 28  shows a two tether embodiment and a low-aspect bottom-stent style anchor. 
         FIGS. 29( a ), 29( b ), 29( c ) and 29( d )  are illustrations of another embodiment of the present device and shows a central stent hub with aperture and having a top (apical) circumferential flange and a bottom (ventricular) circumferential flange connected to the hub, with a top toroidal inflatable ring attached to the top (apical) circumferential flange and a bottom toroidal inflatable ring attached to the bottom (ventricular) circumferential flange.  FIG. 29( a )  is a cross-sectional side view.  FIG. 29( b )  is a perspective top view.  FIG. 29( c )  is a perspective bottom view.  FIG. 29( d )  is an exploded view. 
         FIGS. 30( a ), 30( b ), 30( c ), and 30( d )  are illustrations of another embodiment of the present device and shows a central stent hub with aperture and having a top (apical) circumferential flange connected to the hub, with a top toroidal inflatable ring attached to the top (apical) circumferential flange.  FIG. 30( a )  is a cross-sectional side view.  FIG. 30( b )  is a perspective top view.  FIG. 30( c )  is a perspective bottom view.  FIG. 30( d )  is an exploded view. 
         FIG. 31  is a cross-sectional side view of an illustration of another embodiment of the present device and shows a central stent hub with aperture and having a top (apical) circumferential flange and a bottom (ventricular) circumferential flange connected to the hub, with a top toroidal inflatable ring attached to the top (apical) circumferential flange and a bottom toroidal inflatable ring attached to the bottom (ventricular) circumferential flange, and a vacuum compartment between the top and bottom flanges. 
         FIG. 32  is an illustration of another embodiment of the present device and shows a stent having a single threaded angled edge structure on the exterior shank surface of the stent. 
         FIG. 33  is an illustration of another embodiment of the present device and shows a stent having a single threaded rounded edge structure on the exterior shank surface of the stent. 
         FIG. 34  is an illustration of another embodiment of the present device and shows a stent having a two rounded edge thread structures on the exterior shank surface of the stent. 
         FIG. 35  is an illustration of another embodiment of the present device and shows a stent having a four-thread angled edge structure on the exterior shank surface of the stent. 
         FIG. 36  is an illustration of another embodiment of the present device and shows an offset pear-shape stent structure. 
         FIG. 37  is an illustration of another embodiment of the present device and shows an elongated tapered stent having threading down the entire outer surface of the stent. 
         FIG. 38 ( a )-( b )-( c )-( d )  are illustrations showing in four steps deployment of a passive assist cage having a pliant tubular conduit disposed within.  FIG. 38( a )  shows catheter delivery of a compressed passive assist cage device to the right ventricle.  FIG. 38( b )  shows balloon expansion of the passive cage device.  FIG. 38( c )  shows over-catheter delivery of a pliant tubular conduit into the interior cavity of the passive assist cage device.  FIG. 38( d )  shows mounting of the conduit within the interior cavity of the passive assist cage and withdrawal of the catheter from the patient. 
         FIG. 39  is an illustration of a three-dimensional volumetric representation of a passive assist cage device. 
         FIG. 40  is an illustration of a three-dimensional volumetric representation of a passive assist cage device with cross-sectional representation along line A-A. 
         FIG. 41  is an illustration of a passive assist cage device deployed in the right atrium with pliant tubular conduit extending through the tricuspid valve annulus into the right ventricle. 
         FIG. 42  is an illustration of a passive assist cage device deployed in the left atrium with pliant tubular conduit extending through the mitral valve annulus into the left ventricle. 
         FIG. 43  is an illustration of a passive assist cage device deployed within the left ventricle with pliant tubular conduit disposed within the open cavity of the cage and extending from the mitral valve annulus into the left ventricle. 
         FIG. 44  is an illustration of a passive assist cage device deployed within the right ventricle with pliant tubular conduit in an open position, during diastole, and disposed within the open cavity of the uncompressed cage and extending from the tricuspid valve annulus into the right ventricle. 
         FIG. 45  is an illustration of a passive assist cage device deployed within the right ventricle with pliant tubular conduit in a closed position, during systole, and disposed within the open cavity of the compressed cage and extending from the tricuspid valve annulus into the right ventricle. 
         FIG. 46  is an illustration of a passive assist cage configured for deployment within the right atrium, with a prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular inlet ports for alignment with the superior and inferior vena cava. 
         FIG. 47  is an illustration of another embodiment of a passive assist cage configured for deployment within the right atrium, with a large prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular inlet ports for alignment with the superior and inferior vena cava. 
         FIG. 48  is an illustration of a passive assist cage configured for deployment within the right ventricle, with a prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular outlet ports for alignment with the right ventricular outflow tract. 
         FIG. 49  is an illustration of another embodiment of a passive assist cage configured for deployment within the right ventricle, with a large prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular outlet ports for alignment with the right ventricular outflow tract. 
         FIG. 50  is an illustration of a passive assist cage configured for deployment within the left ventricle, with a prosthetic valve attached to the passive assist cage proximate to the native mitral valve, and with optional vascular outlet ports for alignment with the left ventricular outflow tract. 
         FIG. 51  is an illustration of another embodiment of a passive assist cage configured for deployment within the left ventricle, with a large prosthetic valve attached to the passive assist cage proximate to the native mitral valve, and with optional vascular outlet ports for alignment with the left ventricular outflow tract. 
         FIG. 52  is an illustration of a passive assist cage configured for deployment within the left atrium, with a prosthetic valve attached to the passive assist cage proximate to the native mitral valve, and with optional vascular inlet ports for alignment with the pulmonary veins. 
         FIG. 53  is an illustration of another embodiment of a passive assist cage configured for deployment within the left atrium, with a large prosthetic valve attached to the passive assist cage proximate to the native mitral valve, and with optional vascular inlet ports for alignment with the pulmonary veins. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein. 
     Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. As used herein the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term “comprising” means “including, but not limited to.” 
     Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. 
     With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. 
     It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.” 
     In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group. 
     As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal subparts. As will be understood by one skilled in the art, a range includes each individual member. 
     Definitions 
     In the description that follows, the term “body channel” is used to define a blood conduit or vessel within the body. Of course, the particular application of the prosthetic heart valve determines the body channel at issue. An aortic valve replacement, for example, would be implanted in, or adjacent to, the aortic annulus. Likewise, a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral annulus. Certain features of the present invention are particularly advantageous for one implantation site or the other. However, unless the combination is structurally impossible, or excluded by claim language, any of the heart valve embodiments described herein could be implanted in any body channel. 
     Bore—The inside diameter of the cylinder tube. 
     Bypass—A secondary passage for fluid flow. 
     Discharge hose, or discharge tubing—also called a backwash hose, lay-flat hose. A flexible cylinder or tubing that expands to cylindrical shape (rounded cross-section) due to internal hydraulic pressure when filled with fluid, and that collapses or flattens or seals when the internal hydraulic pressure is reduced by removing or lessening the amount of fluid. 
     Displacement—The volume of fluid displaced by one complete stroke or revolution 
     Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When your heart contracts, it ejects blood from the two pumping chambers (ventricles) 
     As a point of further definition, the term “expandable” is used herein to refer to a component of the heart valve capable of expanding from a first, delivery diameter to a second, implantation diameter. An expandable structure, therefore, does not mean one that might undergo slight expansion from a rise in temperature, or other such incidental cause. Conversely, “non-expandable” should not be interpreted to mean completely rigid or a dimensionally stable, as some slight expansion of conventional “non-expandable” heart valves, for example, may be observed. 
     Force—A push or pull acting upon a body. In a hydraulic cylinder, it is the product of the pressure on the fluid, multiplied by the effective area of the cylinder piston. 
     Prosthetic Valve 
     For mounting within a passive assist cage, the invention contemplates a wide variety of (bio)prosthetic artificial heart valves. Contemplated as within the scope of the invention are ball valves (e.g. Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g. Bjork-Shiley), stented pericardium heart-valve prosthesis&#39; (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valves), as well as homograft and autograft valves. For bioprosthetic pericardial valves, it is contemplated to use bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves. 
     Frame—Stent Structure 
     Preferably, the frame is made from superelastic metal wire, such as Nitinol™ wire or other similarly functioning material. The material may be used for the frame/stent, for the collar, and/or for the apex anchor/bottom stent. It is contemplated as within the scope of the invention to use other shape memory alloys such as Cu—Zn—Al—Ni alloys, Cu—Al—Ni alloys, as well as polymer composites including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers. It is contemplated that the frame/top stent, collar, and bottom stent may be constructed as a braided stent or as a laser cut stent. Such stents are available from any number of commercial manufacturers, such as Pulse Systems. Laser cut stents are preferably made from Nickel-Titanium (Nitinol™), but also without limitation made from stainless steel, cobalt chromium, titanium, and other functionally equivalent metals and alloys, or Pulse Systems braided stent that is shape-set by heat treating on a fixture or mandrel. 
     One key aspect of the stent design is that it be compressible and when released have the stated property that it return to its original (uncompressed) shape. This requirement limits the potential material selections to metals and plastics that have shape memory properties. With regards to metals, Nitinol has been found to be especially useful since it can be processed to be austhenitic, martensitic or super elastic. Martensitic and super elastic alloys can be processed to demonstrate the required compression features. 
     Laser Cut Stent 
     One possible construction of the stent envisions the laser cutting of a thin, isodiametric Nitinol tube. The laser cuts form regular cutouts in the thin Nitinol tube. 
     Secondarily the tube is placed on a mold of the desired shape, heated to the Martensitic temperature and quenched. The treatment of the stent in this manner will form a stent or stent/cuff or atrial sealing gasket that has shape memory properties and will readily revert to the memory shape at the calibrated temperature. 
     Braided Wire Stent 
     A stent can be constructed utilizing simple braiding techniques. Using a Nitinol wire—for example a 0.012″ wire—and a simple braiding fixture, the wire is wound on the braiding fixture in a simple over/under braiding pattern until an isodiametric tube is formed from a single wire. The two loose ends of the wire are coupled using a stainless steel or Nitinol coupling tube into which the loose ends are placed and crimped. Angular braids of approximately 60 degrees have been found to be particularly useful. Secondarily, the braided stent is placed on a shaping fixture and placed in a muffle furnace at a specified temperature to set the stent to the desired shape and to develop the martensitic or super elastic properties desired. 
     Tethers—The tethers are made from surgical-grade materials such as biocompatible polymer suture material. Non-limiting examples of such material include ultra high-molecular weight polyethylene (UHMWPE), 2-0 exPFTE (polytetrafluoroethylene) or 2-0 polypropylene. In one embodiment the tethers are inelastic. It is also contemplated that one or more of the tethers may optionally be elastic to provide an even further degree of compliance of the valve during the cardiac cycle. 
     Tines-Anchors-Tines/Barbs 
     The device can be seated within the valvular annulus through the use of tines or barbs. These may be used in conjunction with, or in place of one or more tethers. The tines or barbs are located to provide attachment to adjacent tissue. Tines are forced into the annular tissue by mechanical means such as using a balloon catheter. In one non-limiting embodiment, the tines may optionally be semi-circular hooks that upon expansion of the stent body, pierce, rotate into, and hold annular tissue securely. 
     Tissue—The tissue used herein is a biological tissue that is a chemically stabilized pericardial tissue of an animal, such as a cow (bovine pericardium) or sheep (ovine pericardium) or pig (porcine pericardium) or horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissue include that used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all products currently used in surgical procedures, and which are marketed as being harvested generally from cattle less than 30 months old. Other patents and publications disclose the surgical use of harvested, biocompatible animal thin tissues suitable herein as biocompatible “jackets” or sleeves for implantable stents, including for example, U.S. Pat. No. 5,554,185 to Block, U.S. Pat. No. 7,108,717 to Design &amp; Performance-Cyprus Limited disclosing a covered stent assembly, U.S. Pat. No. 6,440,164 to Scimed Life Systems, Inc. disclosing a bioprosthetic valve for implantation, and U.S. Pat. No. 5,336,616 to LifeCell Corporation discloses acellular collagen-based tissue matrix for transplantation. 
     In one preferred embodiment, the conduit may optionally be made from a synthetic material such a polyurethane or polytetrafluoroethylene. 
     Where a thin, durable synthetic material is contemplated, e.g. for a covering, synthetic polymer materials such expanded polytetrafluoroethylene or polyester may optionally be used. Other suitable materials may optionally include thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polycarbonate urethane, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include polyolefins, elastomers, polyethylene-glycols, polyethersulphones, polysulphones, polyvinylpyrrolidones, polyvinylchlorides, other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block co-polymers using the same. 
     Referring now to the drawings,  FIG. 1  is an illustration of a cross-section of a heart showing a prosthetic medical device as described and claimed herein deployed in the right ventricle.  FIG. 1  shows prosthetic medical device  100  comprised of top stent/resilient subannular frame  114  supporting the elongated flexible cylinder/pliant tubular conduit  102 . Tethers  134  connect conduit  102  to anchor/bottom stent  126 . Frame (or stent)  114  is anchored below the native tricuspid valve by one or more suitable anchor devices such as surgical clips, clamps, and so forth. Frame  114  is a self-expanding or balloon expandable structure that holds the device within the native annulus and also prevents the device from being ejected into the right atrium during systole. Frame  114 , anchor  126  and tethers  134  may be constructed, in whole or in part, of suitable metal, polymeric, or composite materials including nickel-titanium alloy, cobalt-chromium alloy, high cycle fatigue tolerant polymers including composites containing glass fiber, polymer fiber, carbon fiber, metal fiber, carbon nanotube fiber, and composites containing polymer filler materials. 
       FIG. 2  is an illustration of a cross-section of a heart showing a prosthetic medical device as described and claimed herein deployed in the left ventricle.  FIG. 2  shows prosthetic medical device  200  comprised of top stent/resilient subannular frame  214  supporting the elongated flexible cylinder/pliant tubular conduit  202 . Tethers  234  connect conduit  202  to anchor/bottom stent  226 . Frame (or stent)  214  is anchored below the native mitral valve by one or more suitable anchor devices such as surgical clips, clamps, and so forth. Frame  214  is a self-expanding or balloon expandable structure that holds the device within the native annulus and also prevents the device from being ejected into the right atrium during systole. Frame  214 , anchor  226  and tethers  234  may be constructed, in whole or in part, of suitable metal, polymeric, or composite materials including nickel-titanium alloy, cobalt-chromium alloy, high cycle fatigue tolerant polymers including composites containing glass fiber, polymer fiber, carbon fiber, metal fiber, carbon nanotube fiber, and composites containing polymer filler materials. 
       FIG. 3  is a multi-feature illustration of a various sizes of unassembled top stents, cylinders, tethers, and bottom stents, and also showing a exemplary prosthetic medical device as described and claimed herein.  FIG. 3( a )-( d )  are illustrations of top stents,  FIG. 3( e )  is an illustration of a stent cover,  FIG. 3( f )-( l )  are illustrations of elongated flexible cylinders,  FIG. 3( m )-( n )  are illustrations of bottom stents,  FIG. 3( o )-( p )  are illustrations of tethers,  FIG. 3( q )  is a placement schematic for the right atrium and right ventricle and shows the channel axis, and  FIG. 3( r )  is an illustration of exemplary prosthetic medical device as described and claimed herein. 
       FIGS. 4( a ) and 4( b )  are illustrations showing one embodiment of the present prosthetic medical device  400  deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 4( a ) and ( b )  show a time sequence of a funnel-shaped intra-ventricular cylinder/conduit  402  being compressed by systolic action of the right ventricle on the intraventricular blood.  FIG. 4  shows funnel shaped conduit  402  mounted to supra-annular collar  444  with collar aperture  420  leading down the conduit lumen to tether  434  connected to apical anchor  426 . 
       FIGS. 5( a ) and 5( b )  are illustrations showing one embodiment of the present prosthetic medical device  500  deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 5( a ) and ( b )  show a time sequence of a conic-shaped intra-ventricular cylinder/conduit  502  being compressed by systolic action of the right ventricle on the intraventricular blood.  FIG. 5  shows conic cylinder shaped conduit  502  mounted to supra-annular collar  544  with collar aperture  520  leading down the conduit lumen to tether  534  connected to apical anchor  526 . 
       FIGS. 6( a ) and 6( b )  are illustrations showing one embodiment of the present prosthetic medical device  600  deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 6( a ) and ( b )  show a time sequence of a funnel-shaped intra-ventricular cylinder/conduit  602  being compressed by systolic action of the right ventricle on the intraventricular blood.  FIGS. 6( a ) and ( b )  also show an example of a device having a partial atrial collar.  FIG. 6  shows wide-funnel shaped conduit  602  mounted to sub-annular collar  614  and supra-annular collar  644  with collar aperture  620  leading down the conduit lumen to tether  634  connected to apical anchor  626 . Partial atrial collar panel  650  is shown connected to supra-annular collar  644  and provides additional commissural or other leaflet related sealing to reduce regurgitation. 
       FIGS. 7( a ) and 7( b )  are illustrations showing one embodiment of the present prosthetic medical device  700  deployed in a cross-sectional representation of a left atrium and left ventricle.  FIGS. 7( a ) and ( b )  show a time sequence of a conic-shaped intra-ventricular cylinder/conduit  702  being compressed by systolic action of the left ventricle on the intraventricular blood.  FIGS. 7( a ) and 7( b )  also illustrate a device having a larger panel-shaped atrial collar  750 .  FIG. 7  shows conic-cylinder shaped conduit  702  mounted to sub-annular collar  714  and supra-annular collar  744  with collar aperture  720  leading down the conduit lumen to tether  734  connected to apical anchor  726 . Panel-shaped atrial collar panel  750  is shown connected to supra-annular collar  744  and provides additional commissural or other leaflet related sealing to reduce regurgitation. 
       FIG. 8  is a mid-height horizontal cross-sectional illustration of a heart and shows a top atrial view of a collared embodiment of the present invention  800  having three wide-variety leaflet-collar anchors  846 .  FIG. 8  shows collar  844  having leaflet-collar anchors  846  supporting the pliant tubular conduit  802 .  FIG. 8  also shows internal surface  810  of the conduit  802 . 
       FIGS. 9( a ) and 9( b )  are illustrations showing one embodiment of the present prosthetic medical device  900  deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 9( a ) and ( b )  show a time sequence of an intra-ventricular cylinder/conduit  902  being compressed by systolic action of the right ventricle on the intraventricular blood.  FIGS. 9( a ) and ( b )  also illustrate perivalvular leaflet anchors  952  at the septal and anterior positions that extend from atrium to ventricle.  FIG. 9  shows supra-annular collar  944  and sub-annular stent/frame  914  sandwiching the top spacer segment  940  of the conduit/cylinder  902 , and providing a spindle-type (disc-spacer-disc) annular anchor to mount the device  900  within the annulus. Tethers  934  anchor the bottom end  908  of conduit  902  to the non-ventricular-wall-perforating apex anchor  926 . 
       FIG. 10  is a mid-height horizontal cross-sectional illustration of a heart and shows a top atrial view of a collared embodiment of the present invention  1000  having nine medium-wide-variety leaflet-collar anchors  1046 .  FIG. 10  shows collar  1044  having leaflet-collar anchors  1046  supporting the pliant tubular conduit  1002 .  FIG. 10  also shows internal surface  1010  of the conduit  1002 .  FIG. 10  also shows aperture  1020  as an alternate embodiment to the circular aperture. 
       FIGS. 11( a ) and 11( b )  are illustrations showing one embodiment of the present prosthetic medical device  1100  deployed in a cross-sectional representation of a right atrium and right ventricle.  FIGS. 11( a ) and ( b )  show a time sequence of an intra-ventricular cylinder/conduit  1102  being compressed by systolic action of the right ventricle on the intraventricular blood.  FIGS. 11( a ) and ( b )  also illustrate perivalvular leaflet anchors  1152  at the septal and anterior positions that extend from atrium to ventricle.  FIG. 11  shows supra-annular collar  1144  and sub-annular stent/frame  1114  sandwiching the top spacer segment  1140  of the conduit/cylinder  1102 , and providing a spindle-type (disc-spacer-disc) annular anchor to mount the device  1100  within the annulus. Tethers  1134  anchor the bottom end  1108  of conduit  1102  to the non-ventricular-wall-perforating apex anchor  1126 . 
       FIG. 12  is a graphic representation of the change in right ventricular pressure from diastole to systole to diastole.  FIG. 12  shows the change in cross-sectional shape of the cylinder when a 2-, 3-, or 4-tether embodiment is deployed.  FIG. 12  shows pressure in mm Hg along the Y-axis and the phase of the heart cycle along the X-axis. For the right ventricle, diastole can be, for example, about 5 mm Hg. However, during right ventricular systole, the intraventicular pressure can rise to around 30 mm Hg., closing the conduit.  FIG. 12  shows how in a two-tether embodiment, the conduit collapses to form a horizontal bi-fold seal.  FIG. 12  shows how in a three-tether embodiment, the conduit collapses to form a triangular tri-fold seal.  FIG. 12  also shows how in a four-tether embodiment, the conduit collapses to form a cross-shaped four-fold seal. 
       FIG. 13  is a graphic representation of the change in left ventricular pressure from diastole to systole to diastole.  FIG. 13  shows the change in cross-sectional shape of the cylinder when a 2-, 3-, or 4-tether embodiment is deployed.  FIG. 13  shows pressure in mm Hg along the Y-axis and the phase of the heart cycle along the X-axis. For the left ventricle, diastole can be, for example, as low as 8 mm Hg. However, during left ventricular systole, the intraventicular pressure can rise up to 160 mm Hg. or higher, closing the conduit.  FIG. 13  shows how in a two-tether embodiment, the conduit collapses to form a horizontal bi-fold seal.  FIG. 13  shows how in a three-tether embodiment, the conduit collapses to form a triangular tri-fold seal.  FIG. 13  also shows how in a four-tether embodiment, the conduit collapses to form a cross-shaped four-fold seal. 
       FIGS. 14( a ) and 14( b )  are illustrations showing one embodiment of the present prosthetic medical device  1400 .  FIGS. 14( a ) and ( b )  show a time sequence of an intra-ventricular cylinder/conduit  1402  being compressed by hydro- or hemo-dynamic action of tissue that define a pressure cavity on the intracavity fluid.  FIGS. 14( a ) and ( b )  also illustrate a simple device having only a frame/stent  1414  and cylinder/conduit  1402  having two tethers  1434  attached to tissue anchors  1426 . 
       FIG. 15( a )-( d )  is a multi-component view of an illustration of an hourglass-shaped, three-tether  1534 , cable-type (toroid or piped-ring) top stent  1514  embodiment of the present invention  1500 .  FIG. 15( a )  shows an illustration of an entire device.  FIG. 15( b )  shows a cross-sectional view of just the frame  1514  and conduit  1502  along line C-C and shows internal surface  1510  of conduit.  FIG. 15( c )  shows a bottom view along line B-B and shows how the cylinder/conduit  1502  collapses to a closed position.  FIG. 15( d )  shows a top view along line A-A looking down the interior of the channel  1504 .  FIG. 15  also shows bottom stent/anchor  1526 . 
       FIG. 16( a )-( c )  is a multi-component view of an illustration of an hourglass-shaped, two-tether  1634 , cable-type (toroid) top stent  1614  embodiment of the present invention.  FIG. 16( a )  shows an illustration of an entire device  1600 .  FIG. 16( b )  shows a bottom view along line B-B and shows how the cylinder  1602  collapses to a closed position.  FIG. 16( c )  shows a top view along line A-A looking down the interior of the channel  1604 .  FIG. 16  also shows bottom stent/anchor  1626 . 
       FIG. 17  is an illustration of another embodiment of the present device  1700  and shows a cable-style (toroidal) collar  1744  attached to an hourglass shaped cylinder/conduit  1702  that has a wide-aspect top stent/frame  1714  mounted around the cylinder  1702 .  FIG. 17  shows a two tether  1734  embodiment and a low-aspect bottom-stent style anchor  1726 . 
       FIG. 18  is an illustration of another embodiment of the present device  1800  and shows a cable-style (toroidal) collar  1844  with a large panel  1850  attached to an hourglass shaped conduit/cylinder  1802  that has a narrow-aspect top stent/frame  1814  mounted around the cylinder  1802 .  FIG. 18  shows a two tether  1834  embodiment and a narrow-aspect bottom-stent style anchor  1826 . 
       FIG. 19  is an illustration of another embodiment of the present device  1900  and shows a cable-style (toroidal) collar  1944  with a large panel  1950  attached to an hourglass shaped conduit  1902  but does not have any top stent mounted around the cylinder/conduit  1902 .  FIG. 19  shows a two tether  1934  embodiment and a low-aspect bottom-stent style anchor  1926 . 
       FIG. 20  is an illustration of another embodiment of the present device  2000  and shows a cable-style (toroidal) collar  2044  with a large panel  2050  attached to an hourglass shaped cylinder  2002  and has a covered-frame style top stent  2014  mounted around the cylinder/conduit  2002 .  FIG. 20  shows a two tether  2034  embodiment and a low-aspect bottom-stent style anchor  2026 . 
       FIGS. 21( a ) and 21( b )  is an illustration of another embodiment of the present device  2100  and shows a vacuum-mounting feature.  FIGS. 21( a ) and ( b )  show a time-sequence of the deflation of a filled compartment.  FIGS. 21( a ) and ( b )  show an embodiment whereby a cable-style (toroidal) collar  2144  is attached to an hourglass shaped cylinder  2102  (conduit) that has a covered-frame style top stent  2114  mounted around the cylinder  2102 , but where the top stent  2114  has a covered nitinol frame that supports a deflatable ring  2148 , wherein the deflatable ring  2148  is comprised of a toroid-shaped sealed compartment  2147  (within cover) having a valve  2149 , said sealed compartment  2147  fillable with a biocompatible liquid or gas, wherein upon removal of some or all of the biocompatible liquid or gas, the deflatable ring  2148  works in cooperation with the (non-moving) collar  2144  to compress the top spacer segment  2140  of the cylinder to a reduced height and thereby operate to seal and mount the device within a native annulus.  FIGS. 21( a ) and ( b )  shows a two tether  2134  embodiment and a low-aspect bottom-stent style anchor  2126 .  FIG. 21( c )  shows a cross-sectional view, sans cover. 
       FIGS. 22( a ) and 22( b )  are illustrations of another embodiment of the present device  2200  and shows in sequence an expansion-mounting feature whereby a compressed top-stent  2214  is attached to an hourglass shaped cylinder  2202  but whereby the top-stent  2214  and the bottom stent  2226  are comprised of a compressed material that is released, or of an inelastic deformable material, and thereby operate to seal and mount the device within a native annulus and native mount-area.  FIG. 22  shows a two tether  2234  embodiment and a low-aspect bottom-stent style anchor  2226 . 
       FIGS. 23( a ) and 23( b )  are illustrations of another embodiment of the present device  2300  and shows in sequence an inflatable (or swellable)-mounting feature whereby a cable-style (toroidal) collar  2344  is attached to an hourglass shaped cylinder  2302  that has an uninflated or undeveloped top-stent  2314  attached to the hourglass shaped cylinder  2302 .  FIG. 23( b )  shows whereby the top-stent  2314  with polymer matrix  2354  absorbs liquid and expands, and thereby operates to seal and mount the device within a native annulus.  FIGS. 23( a ) and ( b )  show a two tether  2334  embodiment and, e.g. a tissue anchor(s)  2326 . 
       FIGS. 24( a ) and 24( b )  are illustrations of another embodiment of the present device and show in sequence a thick walled cylinder  2402  being compressed by external pressure and closing the channel  2404 .  FIGS. 24( a ) and ( b )  show a two tether  2434  embodiment and a low-aspect bottom-stent style anchor  2426 .  FIG. 24  also shows how frame  2414  can be configured to be approximately the same height of the conduit  2402 . 
       FIG. 25( a )-( c )  is an illustration of a multiple components on one embodiment of the present invention.  FIG. 25( a )  shows a cross-section of an open channel having two-tethers.  FIG. 25( b )  shows a cross-section of a compressed cylinder and closed channel having two tethers.  FIG. 25( c )  shows an embodiment of the prosthetic medical device having a top stent  2514  attached to a collapsible cylinder conduit  2502 , the top stent  2514  having two contralateral annular anchors  2546 , and a two tether  2534  embodiment and a low-aspect bottom-stent style anchor  2526 . 
       FIG. 26  shows an embodiment of the prosthetic medical device having a top stent  2614  attached to a conic cylinder conduit  2602 , the top stent  2614  having two contralateral annular anchors  2646 , and a three tether  2634  embodiment with two tethers attached to a low-aspect bottom-stent style anchor  2626 , and one tether attached to a tissue anchor  2627 . 
       FIG. 27  is an illustration of another embodiment  2700  of the present device and shows a cable-style (toroidal) collar  2744  attached to an hourglass shaped closed-bottom perforated cylinder/conduit  2702  with round perforations  2756  that has a wide-aspect top stent  2714  mounted around the cylinder  2702 .  FIG. 27  shows a two tether  2734  embodiment and a low-aspect bottom-stent style anchor  2726 . 
       FIG. 28  is an illustration of another embodiment  2800  of the present device and shows a cable-style (toroidal) collar  2844  attached to an hourglass shaped closed-bottom perforated cylinder  2802  with window-pane perforations  2856  and that has a wide-aspect top stent  2814  mounted around the cylinder/conduit  2802 .  FIG. 28  shows a two tether  2834  embodiment and a low-aspect bottom-stent style anchor  2826 . 
       FIGS. 29( a ), 29( b ), 29( c ) and 29( d )  are illustrations of another embodiment of the present device and shows a central stent hub  2944  with aperture  2904  and having a top (apical) circumferential flange  2954  and a bottom (ventricular) circumferential flange  2956  connected to the hub  2944 , with a top toroidal inflatable ring  2948  attached to the top (apical) circumferential flange  2954  and a bottom toroidal inflatable ring  2949  attached to the bottom (ventricular) circumferential flange  2956 .  FIG. 29( a )  is a cross-sectional side view and shows how the native leaflet, indicated by wavy line, are compressed and captured within the circumferential channel formed by the top flange, hub wall, and bottom flange.  FIG. 29( b )  is a perspective top view and shows how the top ring  2948  is at the outer circumference of the flange  2954  with a stent top spacer region leading to the aperture annulus.  FIG. 29( c )  is a perspective bottom view and shows how the bottom ring  2949  and bottom spacer region lead to the subannular aperture annulus. In a preferred embodiment, the pliant tubular channel  2902  is attached to the subannular aperture annulus and leads into the ventricle, shown here in outline form to better show the underside of the stent structure.  FIG. 29( c )  shows tethers  2934  connecting bottom anchor unit  2926  to conduit  2902 .  FIG. 29( d )  is an exploded view and shows the component parts of one embodiment. Fillable (or filled or compressive matrix) top ring  2948  mounts atop top circumferential flange  2954 , and which is in urn connected to central stent hub  2944 . Hub  2944  is connected to bottom circumferential flange  2956 , and which has bottom ring  2949  disposed on its bottom surface. Pliant tubular conduit  2902  is connected in communication with the central aperture of the hub  2944 . Tethers  2934  connect conduit  2902  to bottom anchor/stent  2926 . 
       FIGS. 30( a ), 30( b ), 30( c ) and 30( d )  are illustrations of another embodiment of the present device and shows a central stent hub  3044  with aperture  3004  and having a top (apical) circumferential flange  3054  connected to the hub  3044 , with a top toroidal inflatable ring  3048  attached to the top (apical) circumferential flange  3054 .  FIG. 30( a )  is a cross-sectional side view and shows how the native leaflet, indicated by wavy line, sandwiches the ring and forms a seal to prevent regurgitation during systole.  FIG. 30( b )  is a perspective top view and shows how the top surface of the flange may be left as open mesh stent material.  FIG. 30( c )  is a perspective bottom view and shows the native leaflet flattened and compressed by the inflatable ring above it (not seen).  FIG. 30( c )  also shows pliant tubular channel  3002  is attached to the subannular aperture annulus and leading into the ventricle.  FIG. 30( d )  is an exploded view and shows top flange  3054  connected to central hub  3044 . Sealing ring  3048  is mounted on the underside of the flange  3054 . Conduit  3002  for a channel with and is in communication with the interior channel of hub  3044 . tethers  23034  connect conduit to bottom anchor  3026 . 
       FIG. 31  is a cross-sectional side view of an illustration of another embodiment of the present device and shows a central stent hub  3144  with aperture  3104  and having a top (apical) circumferential flange  3154  and a bottom (ventricular) circumferential flange  3156  connected to the hub  3144 , with a top toroidal inflatable ring  3148  attached to the top (apical) circumferential flange  3154  and a bottom toroidal inflatable ring  3149  attached to the bottom (ventricular) circumferential flange  3156 , and a vacuum compartment  3158  between the top and bottom flanges.  FIG. 31  also shows pliant tubular channel  3102  is attached to the subannular aperture annulus and leading into the ventricle. 
       FIG. 32  is an illustration of another embodiment of the present device and shows a  3214  stent having a single threaded angled edge structure  3260  on the exterior shank surface  3218  of the stent  3214 . This angled edge threading allows for a simple circular screw-type deployment of the device into the native annulus to aid in sealing and sizing of the stent frame into the native annulus. 
       FIG. 33  is an illustration of another embodiment of the present device and shows a stent  3314  having a single threaded rounded edge structure  3360  on the exterior shank surface  3318  of the stent  3314 . This rounded edge threading allows for a simple circular screw-type deployment of the device into the native annulus to aid in sealing and sizing of the stent frame into the native annulus. 
       FIG. 34  is an illustration of another embodiment of the present device and shows a stent  3414  having a first rounded edge thread structure  3460  and a second rounded edge thread structure  3461  on the exterior shank surface  3418  of the stent  3414 . This multiple rounded edge threading allows for a simple circular screw-type deployment of the device into the native annulus to aid in sealing and sizing of the stent frame into the native annulus. 
       FIG. 35  is an illustration of another embodiment of the present device and shows a stent  3514  having a four-thread angled edge structure  3562  on the exterior shank surface  3518  of the stent  3514 . This threading allows for a circular screw-type deployment of the device into the native annulus and allows for proper sizing and seating of the stent frame into the native annulus during deployment since pre-operative radiological studies of the size of the native annulus can be inaccurate leading to the improper selection of the correct size of prosthetic stent frame. 
       FIG. 36  is an illustration of another embodiment of the present device and shows an offset pear-shape stent structure  3614 . 
       FIG. 37  is an illustration of another embodiment of the present device and shows an elongated tapered stent  3714  having threading  3763  down the entire outer surface  3718  of the stent  3714 . This threading allows for a circular screw-type deployment of the device into the native annulus and the tapered form of the stent allows for proper sizing of the the stent during deployment since pre-operative radiological studies of the size of the native annulus can be inaccurate leading to the improper selection of the correct size of prosthetic stent frame. 
       FIG. 38 ( a )-( b )-( c )-( d )  are illustrations showing in four steps deployment of a passive assist cage having a pliant tubular conduit disposed within.  FIG. 38( a )  shows balloon expanding delivery catheter  3866  delivering a compressed, unexpanded passive assist cage device  3864  to the right ventricle.  FIG. 38( b )  shows balloon segment  3867  expansion of the passive cage device  3865 .  FIG. 38( c )  shows over-catheter delivery of a pliant tubular conduit  3802  into the interior cavity of the uncompressed, expanded passive assist cage device  3865 .  FIG. 38( d )  shows mounting of the conduit  3802  within the interior cavity of the passive assist cage  3865  and withdrawal of the catheter  3866  from the patient. 
       FIG. 39  is an illustration of a three-dimensional volumetric representation of a braided-stent embodiment of passive assist cage device  3965 . Conduit  3902  is shown mounted within the cavity of the passive assist cage  3965  with aperture  3904  leading into the interior channel of the conduit  3902 . Passive assist cage  3965  is shown with right ventricular outflow tract (RVOT) outlet  3970  to provide an unobstructed opening for compressed fluid to flow during systolic compression. 
       FIG. 40  is an illustration of a three-dimensional volumetric representation of a laser-cut passive assist cage device  4065  with cross-sectional representation along line A-A. Aperture  4004  is shown leading to the interior of conduit  4002 . Semi-rigid conduit support  4072  is shown attached to or within conduit  4002  to provide a structure to eliminate risk of prolapse of the conduit  4002  during high-pressure compression. In use, during diastole fluid flows unobstructed from the atrium through the conduit  4002  into the ventricle. During compression, systole, the conduit  4002  is configured to collapse along its X-axis, Z-axis, or both (diameter of cylinder is substantially reduced or closed). The conduit  4002  is closed by action of the fluid pressure on its outer surface. The open cavity cage  4065  provides a compressive resistance outward against the inward cardiac ventricular muscle compression. However, during recovery, the open cavity cage  4065  provides an outward spring-like passive assist to the outward moving cardiac ventricular muscle. 
       FIG. 41  is an illustration of a passive assist cage device deployed in the right atrium with pliant tubular conduit extending through the tricuspid valve annulus into the right ventricle. In this embodiment, semi-rigid conduit support is shown attached to or within conduit. 
       FIG. 42  is an illustration of a passive assist cage device deployed in the left atrium with pliant tubular conduit extending through the mitral valve annulus into the left ventricle. In this embodiment, semi-rigid conduit support is shown attached to or within conduit. 
       FIG. 43  is an illustration of a passive assist cage device deployed within the left ventricle with pliant tubular conduit disposed within the open cavity of the cage and extending from the mitral valve annulus into the left ventricle. In this embodiment, semi-rigid conduit support is shown attached to or within conduit. 
       FIG. 44  is an illustration of a passive assist cage device deployed within the right ventricle with pliant tubular conduit in an open position, during diastole, and disposed within the open cavity of the uncompressed cage and extending from the tricuspid valve annulus into the right ventricle. 
       FIG. 45  is an illustration of a passive assist cage device deployed within the right ventricle with pliant tubular conduit in a closed position, during systole, and disposed within the open cavity of the compressed cage and extending from the tricuspid valve annulus into the right ventricle. 
       FIG. 46  is an illustration of a passive assist cage  4665  configured for deployment within the right atrium, with a prosthetic valve  4605  attached to the passive assist cage  4665  proximate to the native tricuspid valve, and with optional vascular inlet ports  4673  for alignment with the superior and inferior vena cava to receive blood entering the right atrium. In use, during diastole, fluid flows unobstructed into the atrium through the inlet ports  4673 . During diastole, the prosthetic valve  4605  is open and releases collected fluid into the adjoining right ventricle. During systole, compression, the valve  4605  is closed by action of the fluid pressure on its ventricular surface. The passive assist cage  4665  provides a compressive resistance outward against the inner surface of the right atrium. During recovery, the passive assist cage  4665  provides an outward spring-like passive assist to the outward moving cardiac atrial tissue muscle. 
       FIG. 47  is an illustration of another embodiment of a passive assist cage configured for deployment within the right atrium, with a large prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular inlet ports for alignment with the superior and inferior vena cava. Similar to  FIG. 46 , in use, during diastole, fluid flows unobstructed into the atrium through the inlet ports  4773 . During diastole, the prosthetic valve  4705  is open and releases collected fluid into the adjoining right ventricle. During systole, compression, the valve  4705  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  4765  provides a compressive resistance outward against the inner surface of the right atrium. During recovery, the passive assist cage  4765  provides an outward spring-like passive assist to the outward moving cardiac atrial tissue muscle. 
       FIG. 48  is an illustration of a passive assist cage  4865  configured for deployment within the right ventricle, with a prosthetic valve  4805  attached to the passive assist cage  4865  proximate to the native tricuspid valve, and with optional vascular outlet ports  4873  for alignment with the right ventricular outflow tract. In use, during diastole, fluid flows unobstructed into the right ventricle through the prosthetic valve  4805 . During diastole, the prosthetic valve  4805  is open and allows collected fluid from the adjoining right atrium into the right ventricle. During systole, compression, the valve  4805  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  4865  provides a compressive resistance outward against the inner surface of the right ventricle. During recovery, the passive assist cage  4865  provides an outward spring-like passive assist to the outward moving cardiac ventricular muscle. 
       FIG. 49  is an illustration of another embodiment of a passive assist cage configured for deployment within the right ventricle, with a large prosthetic valve attached to the passive assist cage proximate to the native tricuspid valve, and with optional vascular outlet ports for alignment with the right ventricular outflow tract. Similar to  FIG. 48 , in use, during diastole, fluid flows unobstructed into the right ventricle through the prosthetic valve  4905 . During diastole, the prosthetic valve  4905  is open and allows collected fluid from the adjoining right atrium into the right ventricle. During systole, compression, the valve  4905  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  4965  provides a compressive resistance outward against the inner surface of the right ventricle. During recovery, the passive assist cage  4965  provides an outward spring-like passive assist to the outward moving cardiac ventricular muscle. 
       FIG. 50  is an illustration of a passive assist cage  5065  configured for deployment within the left ventricle, with a prosthetic valve  5005  attached to the passive assist cage  5065  proximate to the native mitral valve, and with optional vascular outlet ports  5073  for alignment with the left ventricular outflow tract. In use, during diastole, fluid flows unobstructed into the left ventricle through the prosthetic valve  5005 . During diastole, the prosthetic valve  5005  is open and allows collected fluid from the adjoining left atrium into the left ventricle. During systole, compression, the valve  5005  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  5065  provides a compressive resistance outward against the inner surface of the left ventricle. During recovery, the passive assist cage  5065  provides an outward spring-like passive assist to the outward-moving cardiac ventricular muscle. 
       FIG. 51  is an illustration of another embodiment of a passive assist cage configured for deployment within the left ventricle, with a large prosthetic valve attached to the passive assist cage proximate to the native mitral valve, and with optional vascular outlet ports for alignment with the left ventricular outflow tract. Similar to  FIG. 50 , in use, during diastole, fluid flows unobstructed into the left ventricle through the prosthetic valve  5105 . During diastole, the prosthetic valve  5105  is open and allows collected fluid from the adjoining left atrium into the left ventricle. During systole, compression, the valve  5105  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  5165  provides a compressive resistance outward against the inner surface of the left ventricle. During recovery, the passive assist cage  5165  provides an outward spring-like passive assist to the outward-moving cardiac ventricular muscle. 
       FIG. 52  is an illustration of a passive assist cage  5265  configured for deployment within the left atrium, with a prosthetic valve  5205  attached to the passive assist cage  5265  proximate to the native mitral valve, and with optional vascular inlet ports  5273  for alignment with the pulmonary veins. In use, during diastole, fluid flows unobstructed into the left atrium through the pulmonary veins. During diastole, the prosthetic valve  5205  is open and allows collected fluid from the left atrium into the left ventricle. During systole, compression, the prosthetic valve  5205  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  5265  provides a compressive resistance outward against the inner surface of the left atrium. During recovery, the passive assist cage  5265  provides an outward spring-like passive assist to the outward-moving cardiac atrial tissue. 
       FIG. 53  is an illustration of another embodiment of a passive assist cage  5365  configured for deployment within the left atrium, with a large prosthetic valve  5305  attached to the passive assist cage  5365  proximate to the native mitral valve, and with optional vascular inlet ports  5373  for alignment with the pulmonary veins. Similar to  FIG. 52 , in use, during diastole, fluid flows unobstructed into the left atrium through the pulmonary veins. During diastole, the prosthetic valve  5305  is open and allows collected fluid from the left atrium into the left ventricle. During systole, compression, the prosthetic valve  5305  is closed by action of the fluid pressure on its ventricular-facing surface. The passive assist cage  5365  provides a compressive resistance outward against the inner surface of the left atrium. During recovery, the passive assist cage  5265  provides an outward spring-like passive assist to the outward-moving cardiac atrial tissue. 
     LIST OF REFERENCES NUMBERS 
     
         
           100  prosthetic medical device tricuspid 
           102  elongated flexible cylinder (pliant tubular conduit) 
           104  cylinder channel/conduit lumen 
           106  top end 
           108  bottom end 
           110  internal surface 
           112  external surface 
           113  cylinder/conduit mid-segment side wall 
           114  top stent/resilient annular or subannular frame 
           116  top stent channel 
           118  top stent side wall 
           120  top stent top aperture 
           122  top stent bottom aperture 
           124  top stent cover 
           126  bottom stent/anchor nonperforating 
           128  top end of bottom stent 
           130  bottom end of bottom stent 
           132  side wall of bottom stent 
           134  2-5 tethers 
           136  conic cylinder 
           138  top edge of cylinder top end 
           140  top spacer segment of cylinder top end 
           142  stent mounting segment of cylinder top end 
           144  collar 
           846  collar leaflet anchors 
           148  deflatable ring 
           650  collar panel 
           952  annular tissue anchor 
           200  prosthetic medical device mitral 
           202  elongated flexible cylinder (pliant tubular conduit) 
           214  top stent/resilient annular or subannular frame 
           220  top stent top aperture 
           226  bottom stent/anchor nonperforating 
           234  2-5 tethers 
           400  prosthetic medical device 
           402  elongated flexible cylinder (pliant tubular conduit) 
           420  top stent top aperture 
           426  bottom stent/anchor nonperforating 
           434  2-5 tethers 
           444  supra-annular collar 
           500  prosthetic medical device 
           502  elongated flexible cylinder (pliant tubular conduit) 
           520  top stent top aperture 
           526  bottom stent/anchor nonperforating 
           534  2-5 tethers 
           544  supra-annular collar 
           600  prosthetic medical device 
           602  elongated flexible cylinder (pliant tubular conduit) 
           620  top stent top aperture 
           626  bottom stent/anchor nonperforating 
           634  2-5 tethers 
           644  supra-annular collar 
           650  partial atrial collar panel 
           700  prosthetic medical device 
           702  elongated flexible cylinder (pliant tubular conduit) 
           720  top stent top aperture 
           726  bottom stent/anchor nonperforating 
           734  2-5 tethers 
           744  supra-annular collar 
           750  panel shaped atrial collar panel 
           800  prosthetic medical device 
           802  elongated flexible cylinder (pliant tubular conduit) 
           844  supra-annular collar 
           846  wide-variety leaflet-collar anchors 
           900  prosthetic medical device 
           902  elongated flexible cylinder (pliant tubular conduit) 
           908  bottom end of conduit 
           914  sub-annular stent/frame 
           926  bottom stent/anchor nonperforating 
           934  2-5 tethers 
           940  top spacer segment 
           944  supra-annular collar 
           952  perivalvular leaflet anchors 
           1000  prosthetic medical device 
           1002  elongated flexible cylinder (pliant tubular conduit) 
           1044  supra-annular collar 
           1046  wide-variety leaflet-collar anchors 
           1100  prosthetic medical device 
           1102  elongated flexible cylinder (pliant tubular conduit) 
           1108  bottom end of conduit 
           1114  sub-annular stent/frame 
           1126  bottom stent/anchor nonperforating 
           1134  2-5 tethers 
           1140  top spacer segment 
           1144  supra-annular collar 
           1152  perivalvular leaflet anchors 
           1400  prosthetic medical device 
           1402  elongated flexible cylinder (pliant tubular conduit) 
           1414  sub-annular stent/frame 
           1426  bottom stent/anchor nonperforating 
           1434  2-5 tethers 
           1500  prosthetic medical device 
           1502  elongated flexible cylinder (pliant tubular conduit) 
           1514  sub-annular stent/frame 
           1526  bottom stent/anchor nonperforating 
           1534  2-5 tethers 
           1600  prosthetic medical device 
           1602  elongated flexible cylinder (pliant tubular conduit) 
           1614  sub-annular stent/frame 
           1626  bottom stent/anchor nonperforating 
           1634  2-5 tethers 
           1700  prosthetic medical device 
           1702  elongated flexible cylinder (pliant tubular conduit) 
           1714  sub-annular stent/frame 
           1726  bottom stent/anchor nonperforating 
           1734  2-5 tethers 
           1744  toroid collar 
           1800  prosthetic medical device 
           1802  elongated flexible cylinder (pliant tubular conduit) 
           1814  sub-annular stent/frame 
           1826  bottom stent/anchor nonperforating 
           1834  2-5 tethers 
           1844  toroid collar 
           1850  large panel 
           1900  prosthetic medical device 
           1902  elongated flexible cylinder (pliant tubular conduit) 
           1914  sub-annular stent/frame 
           1926  bottom stent/anchor nonperforating 
           1934  2-5 tethers 
           1944  toroidal collar 
           1950  large panel 
           2000  prosthetic medical device 
           2002  elongated flexible cylinder (pliant tubular conduit) 
           2014  sub-annular stent/frame 
           2026  bottom stent/anchor nonperforating 
           2034  2-5 tethers 
           2044  toroidal collar 
           2050  large panel 
           2100  prosthetic medical device 
           2102  elongated flexible cylinder (pliant tubular conduit) 
           2114  sub-annular stent/frame 
           2126  bottom stent/anchor nonperforating 
           2134  2-5 tethers 
           2140  top spacer 
           2144  toroidal collar 
           2147  compartment 
           2148  deflatable ring 
           2149  valve 
           2150  large panel 
           2200  prosthetic medical device 
           2202  elongated flexible cylinder (pliant tubular conduit) 
           2214  sub-annular stent/frame 
           2226  bottom stent/anchor nonperforating 
           2234  2-5 tethers 
           2244  toroidal collar 
           2250  large panel 
           2300  prosthetic medical device 
           2302  elongated flexible cylinder (pliant tubular conduit) 
           2314  sub-annular stent/frame 
           2326  bottom stent/anchor nonperforating 
           2334  2-5 tethers 
           2344  toroidal collar 
           2354  polymer matrix 
           2400  prosthetic medical device 
           2402  elongated flexible cylinder (pliant tubular conduit) 
           2404  channel 
           2414  sub-annular stent/frame 
           2426  bottom stent/anchor nonperforating 
           2434  2-5 tethers 
           2500  prosthetic medical device 
           2502  elongated flexible cylinder (pliant tubular conduit) 
           2504  channel 
           2514  sub-annular stent/frame 
           2526  bottom stent/anchor non-perforating 
           2534  2-5 tethers 
           2546  contralateral annular anchor 
           2600  prosthetic medical device 
           2602  elongated flexible cylinder (pliant tubular conduit) 
           2604  channel 
           2614  sub-annular stent/frame 
           2626  bottom stent/anchor non-perforating 
           2627  tissue anchor 
           2634  2-5 tethers 
           2646  contralateral annular anchor 
           2700  prosthetic medical device 
           2702  elongated flexible cylinder (pliant tubular conduit) 
           2704  channel 
           2714  sub-annular stent/frame 
           2726  bottom stent/anchor non-perforating 
           2734  2-5 tethers 
           2756  round perforations 
           2800  prosthetic medical device 
           2802  elongated flexible cylinder (pliant tubular conduit) 
           2804  channel 
           2814  sub-annular stent/frame 
           2826  bottom stent/anchor non-perforating 
           2834  2-5 tethers 
           2856  window pane perforations 
           2902  pliant tubular conduit 
           2904  aperture 
           2926  bottom anchor 
           2934  tethers 
           2944  central stent hub 
           2948  top toroidal inflatable ring 
           2949  bottom toroidal inflatable ring 
           2954  top (apical) circumferential flange 
           2956  bottom (ventricular) circumferential flange 
           3004  aperture 
           3044  central stent hub 
           3048  top toroidal inflatable ring 
           3054  top (apical) circumferential flange 
           3104  aperture 
           3144  central stent hub 
           3148  top toroidal inflatable ring 
           3149  bottom toroidal inflatable ring 
           3154  top (apical) circumferential flange 
           3156  bottom (ventricular) circumferential flange 
           3158  vacuum component 
           3214  top stent 
           3260  angular threading 
           3218  outer surface 
           3314  top stent 
           3360  rounded threading 
           3318  outer surface 
           3414  top stent 
           3460  first threading 
           3461  second threading 
           3418  outer surface 
           3514  top stent 
           3562  4 threads 
           3518  outer surface 
           3614  pear shape stent 
           3714  tapered stent 
           3763  full length threading 
           3718  outer surface 
           3864  compressed, unexpanded passive assist cage device 
           3865  uncompressed, expanded passive assist cage device 
           3866  balloon expanding delivery catheter 
           3867  balloon segment 
           3802  pliant tubular conduit 
           3902  conduit 
           3904  aperture 
           3965  uncompressed, expanded passive assist cage device 
           3970  right ventricular outflow tract outlet 
           4002  conduit 
           4004  aperture 
           4065  uncompressed, expanded passive assist cage device 
           4072  Semi-rigid conduit support 
           4102  conduit 
           4165  uncompressed, expanded passive assist cage device 
           4172  Semi-rigid conduit support 
           4202  conduit 
           4265  uncompressed, expanded passive assist cage device 
           4272  Semi-rigid conduit support 
           4302  conduit 
           4365  uncompressed, expanded passive assist cage device 
           4372  Semi-rigid conduit support 
           4605  prosthetic valve 
           4665  cage device 
           4673  vascular port 
           4705  prosthetic valve 
           4765  cage device 
           4773  vascular port 
           4805  prosthetic valve 
           4865  cage device 
           4873  vascular port 
           4905  prosthetic valve 
           4965  cage device 
           4973  vascular port 
           5005  prosthetic valve 
           5065  cage device 
           5073  vascular port 
           5105  prosthetic valve 
           5165  cage device 
           5173  vascular port 
           5205  prosthetic valve 
           5265  cage device 
           5273  vascular port 
           5305  prosthetic valve 
           5365  cage device 
           5373  vascular port. 
       
    
     Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments. 
     Having described embodiments for the invention herein, it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the invention disclosed which are within the scope and spirit of the invention as defined by the appended claims. Having thus described the invention with the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.