US20200093616A1 - Percutaneous heart valve - Google Patents

Abstract

A method of delivering a percutaneous heart valve is disclosed. The percutaneous heart valve includes an expandable frame having a plurality of cells and a valve seated inside the expandable frame. The heart valve also includes a proximal anchoring portion and a distal anchoring portion having a plurality of distal anchors. After expansion, the proximal anchoring portion extends distally and a portion of each distal anchor extends proximally. A portion of each distal anchor is positioned radially outwardly from the frame and extends in a direction that is substantially parallel with the longitudinal axis. Proximal portions of the distal anchors are preferably spaced apart by less than two cell lengths from a distal portion of the proximal anchoring portion. During deployment, radial expansion of the frame draws the proximal anchoring portion and the distal anchors into closer proximity with body tissue positioned therebetween.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 15/984,027, filed May 18, 2018, now U.S. Pat. No. 10,456,277, which is a continuation of U.S. application Ser. No. 15/289,834, filed Oct. 10, 2016, now U.S. Pat. No. 9,974,669, which is a continuation of U.S. application Ser. No. 13/747,270, filed Jan. 22, 2013, now U.S. Pat. No. 9,486,336, which is a continuation of U.S. application Ser. No. 13/346,593, filed Jan. 9, 2012, now U.S. Pat. No. 9,433,514, which is a continuation of U.S. application Ser. No. 12/084,586, filed Apr. 13, 2009, now U.S. Pat. No. 8,092,520, which is a national stage of PCT/US2006/043526, filed Nov. 9, 2006, which claims the benefit of U.S. Provisional Application No. 60/735,221, filed Nov. 10, 2005. All of the above applications are incorporated herein by reference in their entirety and are to be considered a part of this specification.
BACKGROUNDField of the Invention
• The present invention relates to a vascular balloon-expandable and/or self-expanding stent that can be used as a connecting/attaching mechanism for various kinds of vascular grafts or other prostheses in the vascular system of the human body.
SUMMARY OF THE INVENTION
• It is a primary object of the present invention to provide a vascular balloon-expandable and/or self-expanding stent to facilitate efficient execution of simple and more complex vascular and cardiac procedures by less invasive and/or percutaneous techniques.
• This and other objects of the present invention are achieved by an expandable vascular stent comprising an m×n array of ovals formed into a cylinder having a diameter, a circumference, an axis, and a length in the direction of the axis, where m is the number of columns of ovals in the circumferential direction and n is the number of rows of ovals in the axial direction. Connecting means located atrows1 and n of the m×n array connect the cylinder to a surrounding body. The array of ovals can be of any size and number in a given stent.
• The ovals have a short axis and a long axis, the short axis of the ovals extending in the circumferential direction and the long axis of the ovals extending in the axial direction. The cylinder is expandable from an initial diameter to a pre-determined final diameter, wherein an increase in the diameter of the stent results in a substantial decrease in the length of the stent to bring the prongs together to produce a connection to the body surrounding the stent.
• The connecting means comprise a plurality of prongs extending inwardly from the outer ends of respective ovals inrows1 and n of the m×n array. The prongs are arranged in facing pairs extending from ovals that are in alignment in the axial direction, and are approximately collinear in ovals having a common long axis, and approximately parallel in ovals having a common short axis.
• Prior to expansion of the cylinder, the prongs substantially conform to the shape of the cylinder. As the stent expands, the distance between the prongs decreases and the prongs extend outwardly from the cylinder to engage the surrounding tissue.
• Circumferential connectors connect adjacent ovals to each other in the circumferential direction and axial connectors connecting adjacent ovals to each other in the axial direction. The circumferential connectors and the axial connectors are positioned between the ovals coincident with the common short and long axes of the ovals, respectively.
• The tube and the prongs can be made of surgical stainless steel, the tube being expandable using an angioplasty balloon; or the tube and the prongs can be made of a memory metal and the tube is self-expanding.
• Other objects, features, and advantages of the present invention will be apparent to those skilled in the art upon a reading of this specification including the accompanying drawings.
• Disclosed herein are embodiments a method of deploying a percutaneous heart valve into a body cavity having an opening surrounded by surrounding body tissue, the method comprising delivering a percutaneous heart valve to the body cavity in a collapsed configuration, the percutaneous heart valve comprising an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame comprising a plurality of cells configured to permit the frame to radially expand and collapse between the collapsed configuration and an expanded configuration, a valve seated inside the expandable frame, a proximal anchoring portion, and a distal anchoring portion comprising a plurality of distal anchors, and radially expanding the expandable frame to the expanded configuration within the opening, wherein, when the percutaneous heart valve is in the expanded configuration the proximal anchoring portion extends at least partially distally, at least a portion of each distal anchor extends proximally to a proximalmost portion of the distal anchor positioned radially outward from the frame, the proximalmost portions extending in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis, at least one of the plurality of distal anchors bends radially outwardly before bending to extend toward the proximal anchoring portion, and the proximalmost portions of the plurality of distal anchors are spaced apart by less than two cell lengths from a distalmost portion of the proximal anchoring portion, wherein radially expanding the expandable frame draws the proximal anchoring portion and the plurality of distal anchors closer together with the surrounding body tissue positioned between the proximal anchoring portion and the plurality of distal anchors. In some embodiments, when the frame is in the expanded configuration within the opening, the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side, and upon movement of the frame within the opening in a proximal direction, the distal anchors longitudinally engage the second side of the surrounding body tissue with a proximallyfacing surface of the proximalmost portions of the distal anchors which are positioned radially outward from the frame. In some embodiments, when the frame is in the expanded configuration within the opening the proximal anchoring portion is positioned on a first side of the surrounding comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in an expanded configuration. In some embodiments, when the frame is in the expanded configuration within the opening, the plurality of circumferentially spaced anchoring tips of the proximal anchoring portion extend at least partially distally toward a first side of the surrounding body tissue. In some embodiments, the body cavity comprises a native aortic valve.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention is better understood by reading the following Detailed Description of the Preferred Embodiments with reference to the accompanying drawing figures, in which like reference numerals refer to like elements throughout, and in which:
• FIG. 1 shows a first embodiment of a stent form stamped from a piece of metal.
• FIG. 2 shows the stent form ofFIG. 1 stretched width-wise.
• FIG. 3 shows the stent form ofFIG. 1 rolled into a stent.
• FIGS. 4A-4C show the progression of deformation of the stent ofFIG. 3 as it is stretched radially along its diameter.
• FIGS. 5A-5Q show the steps in the expansion of the stent ofFIG. 3 in an artery or other body cavity.
• FIG. 6A is a perspective view, partially cut away, of a collapsed prosthetic heart valve loaded in an undeployed stent in accordance with the present invention.
• FIG. 6B is a perspective view, partially cut away, of the prosthetic heart valve and stent ofFIG. 6A in their expanded conditions.
• FIGS. 7A-7C show the progression of deformation of a second embodiment of the stent as it is stretched radially along its diameter.
• FIG. 8A is a side elevational view of a third embodiment of the stent.
• FIG. 8B is a perspective view of the stent ofFIG. 8A.
• FIG. 8C is a side elevational view of the stent ofFIG. 8A in a deformed state after being stretched radially along its diameter.
• FIG. 8D is an enlarged view of a prong of the stent ofFIG. 8A.
• FIG. 8E is a plan view of the stent form ofFIG. 8A.
• FIGS. 9A-9G show the steps in the expansion of the stent ofFIG. 8A in an artery or other body cavity.
• FIG. 10A is a perspective view of a fourth embodiment of the stent.
• FIG. 10B is a plan view of the stent form ofFIG. 10A.
• FIG. 10C is an enlarged view of the prong of the stent ofFIG. 10A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• In describing preferred embodiments of the present invention illustrated in the drawings, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish a similar purpose.
• As shown inFIGS. 3 and 4A-4C, a first embodiment of the device is a balloon expandablestainless steel stent100 that can be expanded from an initial diameter (shown inFIG. 4A) to a pre-determined final diameter (shown inFIG. 4C) depending on the set dimensions of the balloon used to expand it. The configuration of thestent100 is such that, with reference toFIG. 3, an increase in the diameter (D) of the stent will result in a substantial decrease in the length (L) of the stent.
• To achieve this change in the shape and dimension of thestent100, an m×narray100aofovals105 is formed as shown inFIG. 1, where m is the number of columns of ovals in the circumferential direction C and n is the number of rows of ovals in the axial, or lengthwise, direction A, and where the short axis of theovals105 extends in the circumferential direction C and the long axis of theovals105 extends in the axial direction A. Thearray100ashown inFIG. 1 is a 2×5 array. However, thearray100acan be any size greater than 1×1, depending on the desired size of the circumference and the length of the stent.
• With reference toFIGS. 1 and 2, thearray100aofovals105 can be formed by stamping or electrical discharge machining from a sheet or tube of metal, preferably stainless steel.Adjacent ovals105 are connected to each other in the circumferential direction C byconnectors115aand in the axial direction A byconnectors115bpositioned between the ovals coincident with their common short and long axes, respectively.
• At least some of theovals105 at the ends of the stent100 (that is, theovals105 inrows1 and n in the axial direction) have aprong120 extending inwardly from their outer ends in approximate alignment with their longitudinal axes. Theprongs120 are placed in facing pairs extending fromovals105 that are in alignment in the axial direction A. Thus, forovals105 having a common long axis, theprongs120 are approximately collinear; while forovals105 having a common short axis, theprongs120 are approximately parallel.
• There may be intervening “blank”ovals105 without anyprongs120, and which serve merely as spacers. Theblank ovals105 are utilized in some situations where more space is required between the connectingprongs120.
• If thearray100aofovals105 is formed from a sheet of metal, then thearray100ais rolled into a cylinder. The rolled cylinder and the stamped or machined tube have the general configuration of astent100, as shown inFIG. 4A, with the longitudinal axis of the cylinder being parallel to the long axes of theovals105.
• In this embodiment, theprongs120 are pre-bent. That is, at the time thestent100 is formed, theprongs120 are bent outwardly relative to the longitudinal axis of the cylinder, adjacent their attached ends, and also are bent inwardly relative to the longitudinal axis of the cylinder at a point offset from their free ends, in a reverse curve, so as to have a hook configuration.
• Anangioplasty balloon130 is used to expand theundeployed stent100 and to post the expandedstent100 in the wall of an artery or other body cavity. When theballoon130 is inflated, theovals105 expand in the direction of their short axes and contract along the direction of their long axes, deforming theovals105 into diamonds and causing a reduction in the length of thestent100, as shown inFIGS. 4B and 4C. As also shown inFIGS. 4B and 4C, the deformation of theovals105 also causes the approximatelycollinear prongs120 to draw closer together to engage the surrounding tissue and the approximatelyparallel prongs120 to spread farther apart. This deformation of theovals105 and movement of theprongs120 provide the connecting mechanism of thestent100.
• Theangioplasty balloon130 is the correct size and shape to expand thestent100 to the desired size and shape. Theundeployed stent100 is loaded over theballoon130 of aconventional balloon catheter132 and inserted into the artery or other body cavity according to conventional medical procedure. Inflating theballoon130 deploys (opens) the stent100 (that is, causes an increase in its diameter and a decrease in its length), which remains expanded to keep the artery or body cavity open. A high-pressure balloon130 allows the physician to fully expand thestent100 until it is in full contact with the wall of the artery or body cavity. Alow compliance balloon130 is used so that thestent100 and the artery or body cavity will not be over-expanded, and so that theballoon130 will not dog-bone and over-expand the artery or body cavity on either end of thestent100. Thestent100 stays in position after theballoon130 is deflated and removed from the body.
• In instances when thestent100 is self-expanding, i.e. made from memory metal, then upon deployment thestent100 takes its predetermined configuration.
• FIGS. 5A-5Q show the steps in the expansion of the stent ofFIG. 3 in an artery or other body cavity.
• Thestent100 in accordance with the present invention can also be of use as a versatile connector in clinical settings in which it can be pre-attached to a side wall of another prosthesis, such as an endo-luminal graft. It can also be used as a connector to connect main and branch endo-aortic grafts for branch graft repair, as described in my U.S. patent application Ser. No. 10/960,296, filed Oct. 8, 2004.
• Thestent100 in accordance with the present invention can further be used in conjunction with percutaneous heart valve technology. In a percutaneous heart valve procedure, a collapsedpercutaneous heart valve125 is mounted on a balloon-expandable stent100 and threaded through the patient's circulatory system via a catheter to the aortic valve from either an antegrade approach (in which the patient's septum and mitral valve are crossed to reach their native aortic valve) or a retrograde approach (in which thepercutaneous heart valve125 is delivered directly to the aortic valve through the patient's main artery). Once in the aortic valve, thepercutaneous heart valve125 is expanded by a balloon catheter to push the patient's existing valve leaflets aside and anchor inside the valve opening.
• As shown inFIG. 6A, thepercutaneous heart valve125 in a collapsed state can be seated inside theundeployed stent100 in accordance with the present invention, which in turn is loaded over the balloon of a conventional balloon catheter, as previously described. Once thevalve125 andstent100 are positioned in the desired location, theballoon130 is inflated, causing thevalve125 and thestent100 to expand, as shown inFIG. 6B. Thevalve125 is fixed in position by the mechanism provided by thestent100.
• A second embodiment of thestent100′, and the progression of its deformation as it is stretched radially along its diameter, is shown inFIGS. 7A-7C. In this alternate embodiment, thestent100′ is similar to thestent100, but hasadditional prongs135 extending from and perpendicular to theconnectors115apositioned between theovals105, and parallel to the longitudinal axis of thestent100′. Theseprongs135 are for the purpose of attaching thestent100′ to, for example, a branch graft or a valve.
• A third embodiment of thestent300 is shown in its undeployed state inFIGS. 8A and 8B, and in its deployed state after being stretched radially along its diameter inFIG. 8C. In the third embodiment, thestent300 is formed of an m×narray300aofovals305 formed as shown inFIG. 8E. With reference toFIG. 8D, thearray300aofovals305 can be formed by laser-cutting a sheet or tube of metal, preferably stainless steel or a memory metal.Adjacent ovals305 are connected to each other in the circumferential direction C byconnectors315aand in the axial direction A byconnectors315bpositioned between the ovals coincident with their common short and long axes, respectively.
• At least some of theovals305 at the ends of the stent300 (that is, theovals305 inrows1 and n in the axial direction) have aprong320 extending inwardly from their outer ends in approximate alignment with their longitudinal axes. Theprongs320 are placed in facing pairs extending fromovals305 that are in alignment in the axial direction A. Thus, forovals305 having a common long axis, theprongs320 are approximately collinear; while forovals305 having a common short axis, theprongs320 are approximately parallel. The prongs350 are bifurcated, providing two point penetration for better purchase.
• Referring now toFIGS. 8D and 8E, in the embodiment ofFIGS. 8A-8C, eachprong320 includes aspine320aextending the length of the long axis of the oval305 and afurcation320bon either side of thespine320aat a location between the ends of thespine320. Thespine320ahas two end hinge points320cat the ends thereof and oneintermediate hinge point320dat the base of thefurcations320b.The amount by which theovals305 are foreshortened and the angle of the prongs320 (that is, the angle of thefurcations320b) can be adjusted by varying the location of thefurcations320band theintermediate hinge point320drelative to the ends of thespines320 and the end hinge points320c.
• There may be intervening “blank”ovals305 without anyprongs320, and which serve merely as spacers. Theblank ovals305 are utilized in some situations where more space is required between the connectingprongs320. At least some of theovals305 at one end of thestent300 can include a docking socket360 (shown inFIG. 8C) for mating to the cardiac locking pin of a valve frame.
• FIGS. 9A-5Q show the steps in the expansion of the stent ofFIGS. 8A-8C in an artery or other body cavity, using an angioplasty balloon. Theundeployed stent300 is loaded over theballoon130 of aconventional balloon catheter132 and inserted into the artery or other body cavity according to conventional medical procedure. As theballoon130 inflates, theovals305 foreshorten in the axial direction, causing thespines320aof theprongs320 to bend at thehinges320cand320dand the consequent activation of theprongs320. As theballoon130 continues to inflate, the angles assumed by thespines320aat their hinges reach their maximums, bringing opposingfurcations320btogether to engage the tissue therebetween.
• Referring now toFIGS. 10A and 10B, there is shown a fourth embodiment of the stent400. In the fourth embodiment, the stent400 is formed of an m×narray400aofovals405. With reference toFIG. 10B, thearray400aofovals405 can be formed by laser-cutting a sheet or tube of metal, preferably stainless steel.Adjacent ovals405 are connected to each other in the circumferential direction C byconnectors415aand in the axial direction A byconnectors415bpositioned between the ovals coincident with their common short and long axes, respectively.
• At least some of theovals405 at the ends of the stent400 (that is, theovals405 inrows1 and n in the axial direction) have aprong420 extending inwardly from their outer ends in approximate alignment with their longitudinal axes. Theprongs420 are placed in facing pairs extending fromovals405 that are in alignment in the axial direction A.
• As shown inFIG. 10C, eachprong420 has substantially the same configuration as an oval305 and aprong320 of the third embodiment, described above. That is, eachprong420 includes anoval frame420′, a spine420aextending the length of the long axis of theoval frame420′, and a furcation420bon either side of the spine420aat a location between the ends of thespine420. The spine420ahas two end hinge points420cat the ends thereof and oneintermediate hinge point420dat the base of the furcations420b.
• The oval frames420′ are connected at their short axes to theovals405 byconnectors420e,and are connected at one end of their long axes to theovals405 by aconnector420f.Thus, as theovals405 foreshorten, the oval frames420′ also foreshorten. The amount by which the oval frames420′ are foreshortened and the angle of the furcations420bcan be adjusted by varying the location of the furcations420band theintermediate hinge point420drelative to the ends of thespines420 and the end hinge points420c.Preferably, theprongs420 are formed by laser cutting.
• As withstent300, stent400 is loaded over theballoon130 of aconventional balloon catheter132 and inserted into the artery or other body cavity according to conventional medical procedure. As theballoon130 inflates, theovals405 and the oval frames420′ foreshorten in the axial direction, causing the spines420aof theprongs420 to bend at thehinges420cand420dand the consequent activation of theprongs420. As theballoon130 continues to inflate, the angles assumed by the spines420aat their hinges reach their maximums, bringing opposing furcations420btogether to engage the tissue therebetween.
• There may be intervening “blank”ovals405 without anyprongs420, and which serve merely as spacers. Theblank ovals405 are utilized in some situations where more space is required between the connectingprongs420. At least some of theovals405 at one end of the stent400 can include a docking socket (not shown) similar to thedocking socket360 shown inFIG. 8C, for mating to the cardiac locking pin of a valve frame.
• Modifications and variations of the above-described embodiments of the present invention are possible, as appreciated by those skilled in the art in light of the above teachings. It is therefore to be understood that the invention may be practiced otherwise than as specifically described.

Claims (20)

What is claimed is:

1. A method of deploying a percutaneous heart valve into a body cavity having an opening surrounded by surrounding body tissue, the method comprising:

delivering a percutaneous heart valve to the body cavity in a collapsed configuration, the percutaneous heart valve comprising:

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame comprising a plurality of cells configured to permit the frame to radially expand and collapse between the collapsed configuration and an expanded configuration;

a valve seated inside the expandable frame;

a proximal anchoring portion; and

a distal anchoring portion comprising a plurality of distal anchors; and

radially expanding the expandable frame to the expanded configuration within the opening, wherein, when the percutaneous heart valve is in the expanded configuration:

the proximal anchoring portion extends at least partially distally;

at least a portion of each distal anchor extends proximally to a proximalmost portion of the distal anchor positioned radially outward from the frame, the proximalmost portions extending in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis; and

at least one of the plurality of distal anchors bends radially outwardly before bending to extend toward the proximal anchoring portion.

2. The method ofclaim 1, wherein:

when the frame is in the expanded configuration within the opening, the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

upon movement of the frame within the opening in a proximal direction, the distal anchors longitudinally engage the second side of the surrounding body tissue with a proximally-facing surface of the proximalmost portions of the distal anchors which are positioned radially outward from the frame.

3. The method ofclaim 1, wherein, when the frame is in the expanded configuration within the opening:

the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

the proximalmost portions of the distal anchors engage the second side of the surrounding body tissue at a location radially outward of the opening.

4. The method ofclaim 1, wherein the proximal anchoring portion comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in the expanded configuration.

5. The method ofclaim 4, wherein when the frame is in the expanded configuration within the opening, the plurality of circumferentially spaced anchoring tips of the proximal anchoring portion extend at least partially distally toward the first side of the surrounding body tissue.

6. The method ofclaim 1, further comprising forming the cells, the proximal anchoring portion, and the distal anchoring portion by laser cutting.

7. The method ofclaim 1, wherein each of the plurality of distal anchors are connected to distal ends of cells of the frame.

8. The method ofclaim 7, wherein, when the frame is in the expanded configuration, the distal ends of each cell to which the distal anchors are attached are in a position spaced radially outward relative to a portion of the frame located proximal to the distal ends of each cell to which the distal anchors are attached.

9. The method ofclaim 7, wherein, when the frame is in the expanded configuration, the plurality of distal anchors bend radially outwardly to a position spaced radially outward relative to a portion of the frame located proximal to the distal ends of the cells to which the distal anchors are attached, the at least one distal anchor being attached to the distal end of the cell, at least a portion of the at least one distal anchor extending generally parallel to the longitudinal axis.

10. The method ofclaim 1, wherein the body cavity comprises a native valve.

11. The method ofclaim 1, wherein the body cavity comprises a native aortic valve.

12. A method of deploying a percutaneous heart valve within a body cavity having an opening surrounded by surrounding body tissue, the method comprising:

delivering a percutaneous heart valve to the body cavity in a collapsed configuration, the percutaneous heart valve comprising:

an expandable frame comprising a proximal end and a distal end and a longitudinal axis extending therethrough, the expandable frame comprising a plurality of cells configured to permit the frame to radially expand and collapse for deployment within the opening of the body cavity between the collapsed configuration and an expanded configuration;

a valve seated inside the expandable frame;

a proximal anchoring portion; and

a distal anchoring portion comprising a plurality of distal anchors, each distal anchor comprising an attached end connected to the frame, a free end, and a bend between the attached end and the free end; and

radially expanding the expandable frame to the expanded configuration within the opening, wherein, when the percutaneous heart valve is in the expanded configuration:

the proximal anchoring portion extends at least partially distally; and

at least a portion of each distal anchor extends proximally to a proximalmost portion of the distal anchor positioned radially outward from the frame, the proximalmost portions extending in a direction that is more parallel with the longitudinal axis than with a transverse axis perpendicular to the longitudinal axis.

13. The method ofclaim 12, wherein, when the frame is in the expanded configuration, at least a portion of the distal anchors between the attached end and the bend extends radially outward.

14. The method ofclaim 13, wherein, when the frame is in the expanded configuration, the bend orients a portion of the distal anchor immediately after the bend in a direction more parallel with the longitudinal axis than a portion of the distal anchor immediately before the bend.

15. The method ofclaim 12, wherein:

when the frame is in an expanded configuration within the opening, the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

upon movement of the frame within the opening in a proximal direction, the plurality of distal anchors longitudinally engage the second side of the surrounding body tissue with a proximally-facing surface of the proximalmost portions of the distal anchors which are positioned radially outward from the frame.

16. The method ofclaim 12, wherein, when the frame is in the expanded configuration within the opening:

the proximal anchoring portion is positioned on a first side of the surrounding body tissue and the plurality of distal anchors are positioned on a second side of the surrounding body tissue opposite the first side; and

the proximalmost portions of the plurality of distal anchors distal anchors engage the second side of the surrounding body tissue at a location radially outward of the opening.

17. The method ofclaim 12, wherein the proximal anchoring portion comprises a plurality of circumferentially spaced anchoring tips positioned radially outward from the frame when the frame is in an expanded configuration.

18. The method ofclaim 17, wherein when the frame is in the expanded configuration within the opening, the plurality of circumferentially spaced anchoring tips of the proximal anchoring portion extend at least partially distally toward a first side of the surrounding body tissue.

19. The method ofclaim 12, wherein the body cavity comprises a native valve.

20. The method ofclaim 12, wherein the body cavity comprises a native aortic valve.

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