Abstract:
In general, in an aspect, an annulus of a heart valve is caused to dilate to a predetermined configuration. While the annulus is dilated, a valve support is attached to tissue at locations along the annulus. After attachment, the support is caused to contract.

Description:
BACKGROUND 
       [0001]    This description relates to reconfiguring heart features. 
         [0002]    For example, the annulus of a heart valve, a fibrous ring attached to the wall of the heart, maintains the shape of the valve opening and supports the valve leaflets. In a healthy heart, the annulus is typically round and has a diameter that enables the leaflets to close the valve tightly without flapping during contraction of the heart. Because the annulus of the tricuspid valve, for example, is supported more stably by the heart tissue on one side of the annulus than on the other side, the size and shape of the annulus may become distorted over time. The distortion may prevent the valve from closing properly, allowing blood to regurgitate backwards through the valve. The distortion can be corrected, for example, during open heart surgery, by attaching a ring or other support around the annulus to restore its shape and size. 
       SUMMARY 
       [0003]    In general, in an aspect, a force is applied to a tool toward an annulus of a heart valve to cause the annulus to dilate. While the annulus is dilated, a valve support is attached to tissue at locations along the annulus. After attachment, the support is caused to contract. 
         [0004]    Implementations may include one or more of the following features. The valve support is attached to the tool before the annulus is dilated. The valve support is caused to conform to a delivery configuration for attachment. The valve support is expanded before being attached to the tool. The valve support is attached to the tissue by applying a force to the tool in the direction axial to the annulus. The valve support is attached to the tool before attaching the valve support to the tissue. The valve support is attached to the tool by one or more breakable connections, for example, sutures or fingers. The valve support is attached to the tool by forcing the valve support to engage retaining elements on the tool. The valve support is anchored using one or more hooks. The force causes a tapered surface of the tool to engage the annulus. The support is contracted by retracting the tapered head from the annulus. The support contracts itself. 
         [0005]    In general, in an aspect, an annulus of a heart valve is caused to dilate to a predetermined configuration. While the annulus is dilated, a valve support is attached to tissue at locations along the annulus. After attachment, the support is caused to contract. 
         [0006]    Implementations may include one or more of the following features. The valve support is expanded to a delivery configuration before the valve support is attached to the tissue. The valve support is displaced axially along a tapered head of a delivery tool to expand it. The valve support is releasably attached to the tapered head. The annulus of the heart valve is dilated by forcing the tapered head of the delivery tool into the heart valve in a direction axial to the annulus. The support is contracted by retracting the tapered head from the heart valve. The valve support is released when the tapered head is retracted by breaking a connection between the valve support and the tapered head of the tool. The valve support is attached to tissue by forcing hooks into the tissue. 
         [0007]    In general, in an aspect, a valve support is pushed towards an annulus of a heart valve to cause hooks of the support to be driven into tissue at locations along the annulus. The hooks are more securely embedded in the tissue by pulling on the support. 
         [0008]    Implementations may include one or more of the following features. The valve support includes an annular body, and the hooks rotate about the annular body to become more securely embedded. The valve support is pushed by pushing on a delivery tool that carries the valve support. The support is pulled by pulling on a delivery tool that carries the support. The valve support is released from the tool after the hooks are more securely embedded. 
         [0009]    In general, in an aspect, a catheter traverses a body lumen to place a delivery tool that carries a valve support at an annulus of a heart valve. The catheter is pushed toward the annulus of the heart valve to cause the delivery tool to dilate the annulus. 
         [0010]    Implementations may include one or more of the following features. The catheter is pushed toward the annulus to attach the valve support to the annulus. The catheter is pulled to release the valve support after it is attached to the annulus. The valve support then contracts. The valve support is sheathed before the catheter is caused to traverse the body lumen and unsheathed in the vicinity of the heart valve. The sheathing and unsheathing is done by moving the catheter and the sheath relative to one another to cause the valve support to be compressed and expanded, respectively. 
         [0011]    In general, in an aspect, an apparatus includes an annular heart valve support and hooks connected to the support to attach the support along an annulus of a heart valve, each of the hooks having (a) a sharp free end facing a first direction, (b) a connection end where the hook is attached to the support, and (c) a bend located between the free end and the connection end, the bend defining a sharp feature facing in a second direction generally opposite to the first direction. 
         [0012]    Implementations may include one or more of the following features. The support is expandable and contractable. The support includes at least one of stainless steel, gold, Nitinol, and a biologically compatible elastomer. The support includes a helical torsion spring. The hooks are rotatable about the support. The hooks comprise at least one of platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, Nitinol, and alloys thereof. 
         [0013]    In general, in an aspect, an apparatus includes a tool bearing a tapered outer surface, a heart valve support, and a connection between the tool and the support to translate forces from the tool to the support in each of two opposite directions along an axis of a heart valve and to release when the force along one of the axial directions exceeds a predetermined threshold. 
         [0014]    Implementations may include one or more of the following features. The tool includes a tapered outer surface. The tapered outer surface includes interconnected struts defining apertures. The connection includes at least one retaining element on an outer surface of the tool. The valve support includes hooks each having a sharp free end facing in a first direction, a connection end where the hook is attached to the support, and a bend located between the free end and the connection end, the bend defining a sharp feature facing in a second direction generally opposite the first direction. The tool includes a tip at a narrow end of the tapered outer surface, and the tapered outer surface is evertable when the tip is pulled toward a broader end of the tapered outer surface. A movable element is connected to the tip and configured to pull the tip to evert the tapered outer surface. A sheath covers the tapered outer surface and cause the tapered outer surface to be collapsed when covered. The tool includes a self-expanding, semi-rigid net. 
         [0015]    In general, in an aspect, a force is applied on a tool toward an annular feature of a heart to cause the feature to dilate. While the feature is dilated, a support is attached to tissue at locations along a periphery of the annular feature. After attachment, the support is caused to contract to reconfigure the feature. In some implementations, the feature comprises a left atrial appendage. 
         [0016]    Among advantages of these and other aspects and features are one or more of the following. The heart valve support can be attached simultaneously at multiple locations along the circumference of the valve annular, which reduces the duration and risk of the procedure. In some uses, the valve support can be attached without the physician having a clear view (or any view) of the valve opening, for example, during open heart surgery or when the valve support is delivered on a catheter. The valve support is self-centering and the delivery tool accommodates heart valves and heart valve supports of different sizes. The tool permits blood to flow through the valve while the support is being attached to the valve annulus. Tricuspid valve and mitral valve regurgitation can be reduced. 
         [0017]    These and other aspects and features, and combinations of them, may be expressed as apparatus, methods, systems, and in other ways. 
         [0018]    Other features and advantages will be apparent from the description and the claims. 
     
    
     
       DESCRIPTION 
         [0019]      FIGS. 1A through 1H  show delivery of a heart valve support. 
           [0020]      FIGS. 2A through 2D  are perspective view of a heart valve support. 
           [0021]      FIG. 2E  is a plan view of a recurved hook. 
           [0022]      FIG. 3  is a section side view of a heart valve support. 
           [0023]      FIGS. 4A through 4C  are side and detailed views of a delivery tool and heart valve support. 
           [0024]      FIG. 5  is a side view of a delivery tool. 
           [0025]      FIGS. 6A and 6B  are sectional side views of a catheter delivery tool. 
           [0026]      FIGS. 7A through 8I  show delivery of a heart valve support. 
       
    
    
       [0027]    As shown in the examples of  FIGS. 1A through 1G  distortion of an annulus  18  of a heart valve  16  can be corrected simply and quickly by the following steps: 
         [0028]    A. Push  201  ( FIG. 1A ) a conical head end basket  220  of a delivery tool  200  into the valve to force the distorted annulus ( 203 ,  FIG. 1F ) to conform to a desired configuration (e.g., a circle  205 ,  FIG. 1G ) and to a size that is larger (e.g., in diameter  207 ) than a desired final diameter  209  of the annulus ( FIG. 1H ). (The tool and basket are shown in side view and the valve and annulus are shown in sectional side view.) 
         [0029]    B. Continue to push  201  the delivery tool to drive an expander heart valve support  100  (which has the desired configuration and the larger size and is temporarily held in its expanded configuration on the tool) towards the annulus to seat multiple recurved hooks  120  located along the periphery of the support simultaneously into the valve tissue at multiple locations along the periphery  121  of the annulus ( FIG. 1B ). 
         [0030]    C. After the hooks are seated, pull  209  ( FIG. 1C ) on and evert the tip  230  of the head end basket from the inside to cause the support to roll so that the tips  122  of the hooks rotate  211  and embed themselves more securely into the annulus tissue ( FIG. 1C ). 
         [0031]    D. After the hooks are further embedded, continue to pull  209  ( FIG. 1D ) on the inside  213  of the tip of the head end basket to break the tool away from the support ( FIG. 1E ), allowing the support to contract to its final size and shape  215  ( FIG. 1H ) and leaving the support permanently in place to maintain the annulus in the desired final configuration and size. 
         [0032]    The entire procedure can be performed in less than a minute in many cases. By temporarily forcing the annulus of the valve to expand to the desired circular shape, it is possible to attach the support quickly, easily, and somewhat automatically by forcing multiple hooks into the tissue at one time. The physician avoids having to attach individual sutures or clips one at a time along the periphery of a distorted annulus and then cinch them together to reform the supported annulus to a desired shape and size. Thus, the physician does not even need to be able to see the annulus clearly (or at all). Once attached, when the tool is removed, the support automatically springs back to its final shape and size. 
         [0033]    As shown in  FIGS. 2A and 2D , in some implementations, the support includes a circular ring body  110  that bears the hooks  120 . The body  110  can be expanded from (a) a minimal-diameter long-term configuration ( FIG. 2A ) to which it conforms after it has been attached to the annulus to (b) an expanded delivery configuration ( FIG. 2D ) to which it conforms when it is held on the head end basket of the tool and while it is being attached in the steps shown in  FIGS. 1A ,  1 B, and  1 C. The long-term configuration is normally circular and has the diameter of a healthy annulus for a particular patient. When attached, the support maintains the health configuration of the annulus so that the valve will work properly. 
         [0034]    In some examples, the body  110  has the same shape (e.g., circular) but different diameters in the delivery configuration and the long-term configuration. The body is constructed of a material or in a manner that biases the body to contract to the long-term configuration. For example, all or portions of the body  110  may be formed as a helical spring  110   a  such as a continuous helical spring connected at opposite ends to form a circular body or one or more interconnected helical spring segments ( FIG. 2B ). In some examples, the support body  110   b  may be a band of shape memory material such as Nitinol or a biologically compatible elastomer that will return to the long-term configuration after being expanded to the delivery configuration ( FIG. 2C ). 
         [0035]    The hooks  120  may number as few as three or as many as ten or twenty or more and may be arranged at equal intervals along the body or at unequal intervals as needed to make the body easy and quick to delivery, permanent in its placement, and effective in correcting distortion of the valve annulus. The hooks are configured and together mounted along the circular outer periphery so that they can be inserted simultaneously into the tissue along the periphery of the annulus and then firmly embedded when the tool is pulled away and the basket is everted. 
         [0036]    For this reason, as shown in  FIG. 2E  each of the hooks has two pointed features. One pointed feature is a sharp free end  122  pointing away from the valve leaflets during delivery. The other pointed feature is a barb  128  formed at a bend between the sharp free end  122  and an opposite connection end  124  where the hook is attached, e.g., welded or glued, to the body  110 . The barb points toward the valve leaflets during delivery. 
         [0037]    Each hook  120  can be formed of biologically compatible materials such as platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, Nitinol, and alloys, polymers, or other materials. During delivery the barbs of the hooks are together forced into the tissue at a series of locations around the outer periphery of the temporarily expanded annulus. In a later step, the sharp free ends are forced to rotate somewhat away from the leaflets for permanent attachment. 
         [0038]    To cause the hooks to rotate during delivery, the hooks  120  are attached permanently to the support body  110  and the support body can be rolled  123  ( FIG. 3 ) about an axis  112  of the support body, as indicated. One way to cause the rolling of the support body and the associated rotation of the hooks is to enable the body to change its configuration by rotation of the entire body about an axis represented by the central circular axis  153 , much as a rubber o-ring can be rolled about its central circular axis. The reconfiguration of the body to cause the rotation of the hooks can be achieved in other ways. 
         [0039]    In some examples, applying an axial force (arrows  113 ) to the inner peripheral edge of the ring (we sometimes refer to the support broadly as a ring) will cause the ring to tend to roll and the hooks to embed themselves in the annulus as intended. By properly mounting the inner periphery of the ring on the outer periphery of the delivery tool, the axial force  113  can be applied by pulling the tool away from the leaflets of the valve, as explained earlier. 
         [0040]    For delivery to the valve annulus, the valve support  100  is expanded to its delivery configuration and temporarily mounted on a delivery head  220  of the tool  200  ( FIG. 4A ). The support must be expanded enough in its temporary mounting on the tool so that when the head-end basket of the tool is pushed against the annulus to force it to expand to the size and shape of the expanded support, the annulus has reached a circular, non-distorted shape. The tapered profile of the head end basket of the delivery tool allows the tool to accommodate supports of various sizes. 
         [0041]    The heart valve support  100  is held in place on the delivery head  220  using one or more releasable connections  246 . The connections  246  are arranged to translate forces from the tool  200  to the support  100  in either of two opposite directions,  248  and  250  toward or away from the leaflets of the valve. When the support has been embedded in the annulus and the tool is pulled in the direction  250  to release it from the support, the force on the connections  246  exceeds a predetermined threshold, the connections break, releasing the tool from the support at the end of the delivery process. The connections  246  may be, in some examples, breakable sutures  252  ( FIG. 4A ). 
         [0042]    In some examples, the connections  246  include retainers that can take, e.g., the configurations shown as  254   a  or  254   b  ( FIGS. 4B &amp; 4C , respectively). In the example shown in  FIG. 4B , the retaining element  254   a  has one rigid finger  256  to translate forces from the tool  200  to the support  100  when the tool is moved in direction  248  while the support is attached to the tool and being pushed into the heart tissue. A second deformable finger  258  aids in maintaining the connection between the support  100  and the tool  200  when the tool is moved in direction  250  and is deformable (dashed lines) to release the valve support  100  from the tool  200  when the force in direction  250  relative to the embedded support exceeds a predetermined threshold. 
         [0043]    In the example shown in  FIG. 4C , the retaining element  254   b  includes a finger  260  having a crook  262  to receive the support  100  and to translate forces from the tool  200  to the support  100  when the tool is moved in direction  248 . The finger has a resiliently deformable tip  264  that is biased towards the tapered body  222  and helps to maintain the connection between the support  100  and the tool  200  and is deformable (shown in hidden lines) to release the valve support  100  from the tool  200  when the tool is moved in the second axial direction  250  against an embedded support and the force exceeds a predetermined threshold. 
         [0044]    As shown in  FIG. 5 , in an example of a tool  200  that can be used for delivery of the support during open heart surgery, a basket  220  is connected at its broad end to a set of stiff wires or other rigid projections  216  from a long shaft  210  having a handle  212  at the operator&#39;s end  214 . Thus the projections  216  connect the shaft  210  to the basket  220  and transfer pulling or pushing force between the shaft and the basket (and in turn to the support). 
         [0045]    The example of the basket shown in  FIG. 5  includes a tapered body  222  having a network of interconnected struts  224  defining an array of openings  226  together forming a tapered semi-rigid net. The basket (which we also sometimes refer to as a delivery head)  220  has a rounded tip  228 . The head  222  tapers radially outwardly with distance along a longitudinal axis  234  of the head  220  from the tip  228  towards the operator. The broad end  232  of the tapered body  222  is firmly attached to the projections  216 , which taper in the opposite direction from the taper of the basket. 
         [0046]    In some implementations, the shaft  210  defines a lumen  236  extending between the heart valve end  218  of the shaft  210  and the handle  212 . A wire  238  is arranged to move freely back and forth within the lumen  236 . The wire  238  has one end  240  that extends from the handle  212  and an opposite end  242  that is connected to the inside of tip  228 . The wire  238  can be pulled (arrow  244 ) to cause the delivery head  220  to collapse (hidden lines) and evert radially inwardly starting at the tip  228 . 
         [0047]    Returning to a more detailed discussion of  FIGS. 1A through 1E , the operator begins the delivery of the support by pushing the tapered end  230  of the head basket  220  into the valve  16  (e.g., the tricuspid valve) to cause the valve leaflets  14  to spread apart. Because the head-end basket is tapered, by continuing to push, the operator can cause the annulus  18  of the tricuspid valve  16  to conform to a desired shape, typically circular. During insertion, because of its taper, the head-end basket is self-centering. The taper of the basket  220  translates the insertion force in direction  248  in a radial force that causes the annulus  18  to expand and temporarily assume a desired shape (and a larger than final diameter). 
         [0048]    As the operator continues to push on the tool, the ring of barbs of the hooks touch and then enter the heart tissue along a ring defined by the outer periphery of the annulus and the sharp free ends of the hooks enter and seat themselves within the tissue, much like fish hooks. 
         [0049]    Once the hooks are embedded in the tissue, the operator pulls on the near end  240  of wire  238  to cause the basket  220  to collapse, evert, and be drawn out of the valve  16 . Eventually, the everted portion of the basket reaches the valve support  100 . By further tugging, the operator causes the body  110  of the support  100  to roll about its central axis (as in the o-ring example mentioned early) which causes the hooks  120  to embed firmly in the tissue of the annulus  18  of the valve  16 . 
         [0050]    Using a final tug, the operator breaks the connection between the tool  200  and the valve support  100  and removes the tool  200 , leaving the valve support  100  in place. As the basket  220  passes the points of connection  246 , the forces exerted by the embedded hooks  120  on the support body  110 , acting in direction  248 , exceed the forces exerted by the withdrawing basket  220  on the support body  110  (through the connections  246 ), acting in direction  250 , thereby causing the connections  246  to release the support  100 . The tool  200  is then withdrawn, allowing the valve support  100 , along with the annulus  18 , to contract to the long-run configuration. 
         [0051]    In implementations useful for delivery of the support percutaneously, as shown in  FIG. 6A , the delivery head  220   a  can be made, for example, from a shape memory alloy, such as Nitinol, which will allow the body  222   a  to be collapsed radially toward the longitudinal axis  234   a  during delivery of the head from a percutaneous entry point into the heart. The delivery head  220   a  is biased towards the expanded, tapered orientation shown in  FIG. 6A . Thus, the delivery head  220   a,  in the form of a tapered semi-rigid net, is connected to a catheter shaft  210   a  through projections  216   a  that extend radially outwardly from the catheter shaft  210   a  and taper in a direction opposite the taper of the delivery head  220   a.    
         [0052]    The projections  216   a  are resiliently mounted to the catheter shaft  210   a  and are biased towards the tapered orientation shown, for example, by spring biased projections  216   b  shown in  FIG. 6B . The projections  216   a  include springs  278 , e.g., torsion springs (as shown), mounted to the catheter shaft  210   a  and forming a resilient connection. 
         [0053]    A wire  238   a  slides within a lumen  236   a  of the shaft  210   a  in a manner similar to the one described earlier. 
         [0054]    The tool  200   a  also includes a sheath  280  in which the catheter shaft  210   a  can slide during placement of the support. The sheath  280 , the catheter shaft  210   a,  and the wire  238   a  are all flexible along their lengths to allow the tool  200   a  to be deflected and articulated along a blood vessel to reach the heart. 
         [0055]    To delivery the support percutaneously, as shown in  FIG. 7A , when the delivery head is prepared for use, the sheath  280  is retracted beyond the projections  216   a,  allowing the delivery head  220   a  to expand. The valve support  100  is then expanded to the delivery configuration and mounted on the tapered body  222   a.  The valve support  100  is connected to the delivery head  220   a  using releasable connections, e.g., breakable sutures and/or retaining elements (as described earlier). 
         [0056]    The sheath  280  is then moved along the catheter shaft  210   a  towards the delivery head  220 , causing the projections  216   a  and the delivery head  220   a  to contract radially inwardly to fit within the sheath  280 , as shown in  FIG. 7B . In the contracted configuration, the tip  228   a  of the delivery head  220   a  fits against the end  282  of the sheath  280 . The rounded tip  228   a  may provide easier delivery and maneuverability in navigating the blood vessels to reach the heart. 
         [0057]    To deliver the support to the valve annulus, the end  230  of the tool  200   a  is fed percutaneously through blood vessels and into the right atrium  24  ( FIG. 8A ). The sheath  280  is then retracted, exposing the valve support  100  and allowing the projections  216   a,  the delivery head  220   a,  and the support  100  to expand, as shown in  FIG. 8A . The catheter shaft  210   a  is then advanced, e.g., under image guidance, in direction  248   a  along an axis  30  of the annulus  18 . The operator forces the distal end  230   a  of the self-centering delivery head  220   a  into the valve  16  ( FIG. 8B ) using feel or image guidance, without actually seeing the valve  16 . 
         [0058]    Once the tip is in the valve  16 , the operator pushes on the end  214   a  of the catheter shaft  210   a  to force the tool further into the valve  16 . This causes the tapered body  222   a  of the delivery head  220   a  to restore the shape of the annulus  18  to a circle or other desired shape (such as the distinctive “D” shape of a healthy mitral valve). The tool  200   a  is self-centering because of its shape. The net-like construction of the delivery head  220   a  (and the head used in open heart surgery, also) allows blood to flow through the valve even while the delivery head  220   a  is inserted. 
         [0059]    As tool  200   a  reaches the point at which the support hooks touch the annulus, by giving an additional push, the operator drives the hooks  120  of the valve support  100  together into all of the annular locations at which it is to be attached, as shown in  FIG. 8C . The configuration of the valve support  100  and the tool  200   a  and the manner of temporary attachment of the support  100  to the tool  200   a  assure that the hooks  120  will penetrate the valve  16  exactly at the correct positions, just along the outer edge of the annulus  18 . 
         [0060]    Once the valve support  100  has been attached to the valve  16 , the operator pulls on the proximal end  240   a  causing the delivery head  220   a  to evert (hidden dashed lines) and be drawn out of the valve  16  (shown in  FIG. 8D ). Eventually the everted portion of the tool  200   a  reaches the valve support  100 . By further tugging, the operator causes the torus of the support  100  to roll all around its periphery which jams the hooks  120  securely into the annulus  18  of the valve  16 , as illustrated in  FIG. 8E , seating the support permanently and permitting later growth of tissue around the support  100 . The depth and radial extent of each of the placed hooks  120  is essentially the same as a conventional suture so that their placement is likely to be as effective and familiar to the operator and others as conventional sutures. 
         [0061]    Using a final tug, the operator breaks the connections  246  between the tool  200   a  and the valve support  100  and retracts the catheter shaft  210 , leaving the support  100  in place. The catheter shaft  210  is retracted to a position beyond the valve annulus  18  and the wire is advanced in the first direction allowing the delivery head  220   a  to assume its original tapered shape ( FIG. 8F ). The catheter shaft  210   a  is then retracted into the sheath  280  ( FIG. 8G ), and the tool  200   a  is withdrawn. 
         [0062]    In other examples, as shown in  FIGS. 8H and 8I , the tip  228   a  of the tool  200   a  has a compressed dimension that is smaller than an internal diameter  284  of the sheath  280 , permitting the catheter shaft  210   a  to be retracted directly into the sheath  280  after deployment, as shown in  FIG. 8I . 
         [0063]    With the tool  200   a  withdrawn, the valve support  100  contracts reshaping the annulus  18  such that the valve leaflets  14  coapt to prevent a backflow of blood during systole. 
         [0064]    Other implementations are within the scope of the claims. 
         [0065]    For example, distortion of either the tricuspid valve or mitral valve can be corrected. For tricuspid valve repair, the hooks can be arranged around only about three-quarters of the support and therefore the annulus. For mitral valve repair, the hooks can cover the entire periphery of the annulus. For mitral valve repair, a back-up valve can be provided as part of the delivery tool to maintain heart function during the delivery procedure. Materials other than shape memory materials may be used as the material for the support body, and other ways can be used to force the support back to a desired size following expansion, including, for example, cross-bars that span the opening of the support. 
         [0066]    In addition, the left atrial appendage of the heart can be closed. For example, the tool can be pushed into an opening of an atrial appendage causing the opening to assume a predetermined shape. The tool can be continued to be pushed in order to embed the hooks of the expanded support into the periphery of the opening of the appendage. The tool can then be withdrawn, releasing the support, and allowing the support to contract. The support can have a relatively small contracted diameter such that, when the tool is withdrawn, releasing the support, the support can contract to a relatively small size, effectively closing off the appendage. 
         [0067]    In addition to the open heart and percutaneous deployment procedures, the valve support can also be deployed through the chest. 
         [0068]    The head of the tool need not be a basket, but can take any form and strength that enables the valve annulus to be forced open to a shape that corresponds to the shape of the support. The basket can be made of a wide variety of materials. The basket can be held and pushed using a wide variety of structural mechanisms that permit both pushing and pulling on the support both to seat and embed the support in the annulus tissue and disconnect the support from the tool. 
         [0069]    The tool need not be conical. 
         [0070]    The support could take a wide variety of configurations, sizes, and shapes, and be made of a wide variety of materials. 
         [0071]    The hooks could be replaced by other devices to seat and embed the support using the pushing force of the tool. 
         [0072]    The hooks of the support need not be embedded directly in the annulus but might be embedded in adjacent tissue, for example.