Patent Description:
The present invention relates in general to percutaneous delivery of medical implants. More specifically, the present invention relates to prosthetic cardiac valves.

Dilation of the annulus of a heart valve, such as that caused by ischemic heart disease, prevents the valve leaflets from fully coapting when the valve is closed. Regurgitation of blood from the ventricle into the atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the ventricle secondary to a volume overload and a pressure overload of the atrium.

<CIT> discloses apparatus for use with a native heart valve wherein a tubular portion of a valve frame circumscribes a longitudinal axis, and defines a lumen along the axis and a plurality of valve-frame coupling elements disposed circumferentially around the axis. An outer frame: (a) comprises a ring defined by a pattern of alternating peaks and troughs, the pattern having an amplitude, (b) comprises a plurality of legs, coupled to the ring at respective troughs, and (c) is shaped to define a plurality of outer-frame coupling elements, each coupled to the ring at a respective peak, and fixed with respect to a respective valve-frame coupling element. Compression of the tubular portion from an expanded state toward a compressed state reduces a circumferential distance between each of the outer-frame coupling elements and its adjacent outer-frame coupling elements, and increases the amplitude of the pattern of the ring.

An implant is provided having self-expanding portions, and non-self-expanding portions. The implant comprises a non-self-expanding tubular frame, which is balloon-expandable. The implant further comprises an outer frame, which comprises self-expanding flanges and a self-expanding upstream support portion. The self-expanding nature of the flanges and upstream support portion is provided by the outer frame being composed of a shape-memory alloy. The tubular frame is composed of a different material.

The outer frame is coupled to the tubular frame via pins that are composed of the same material as the tubular frame. One end of each pin is secured to the outer frame by a head of the pin. The other end of each pin is secured to the tubular frame by welding.

A delivery tool comprises a capsule that has two capsule-portions, one to constrain the flanges, and one to constrain the upstream support portion. The delivery tool further comprises a balloon, disposed within the tubular frame. At the implantation site, the flanges and upstream support portion are released from the capsule, and automatically deflect radially outwards. Subsequently, the balloon is inflated to radially expand the tubular frame.

The delivery tool further comprises projections, which are sufficiently rigid to axially push the tubular frame in order to press the flanges against tissue at the implantation site, but which are sufficiently flexible to not inhibit inflation of the balloon.

There is therefore provided, in accordance with the present invention, apparatus for use at a native valve of a heart of a subject, the apparatus including:.

In an embodiment, the prosthetic valve further includes one or more prosthetic valve leaflets disposed within the lumen and coupled to the tubular frame.

In an embodiment, the tubular frame is disposed within the downstream capsule-portion of the capsule.

In an embodiment, the tubular frame is composed of a material that is not a shape-memory alloy.

In an embodiment, the tubular frame is composed of steel.

In an embodiment, the tubular frame is composed of cobalt chrome.

In an embodiment, the flanges are composed of a shape-memory alloy.

In an embodiment, the flanges are composed of nickel titanium.

In an embodiment, the balloon is fixed to the shaft.

In an embodiment, both the upstream capsule-portion and the downstream capsule-portion are axially movable with respect to the shaft.

In an embodiment, the upstream capsule-portion is retractable from over the upstream support portion by being moved away from the balloon, and the downstream capsule-portion is retractable from over the flanges by being moved away from the balloon.

In an embodiment, the delivery tool further includes one or more elongate projections disposed within the downstream capsule-portion, each of the projections having (i) a tip-portion, and (ii) a base-portion, disposed deeper than the tip-portion into the downstream capsule-portion, the projections arranged circumferentially around the shaft-axis such that the tip-portions are arranged circumferentially around a downstream balloon-portion of the balloon, with the tip-portion of each projection being closer than its corresponding base-portion to the tubular frame.

In an embodiment, each of the projections is sufficiently stiff that, when pushed against the tubular frame, it is capable of applying, to the tubular frame, an axial pushing force of at least <NUM> N.

In an embodiment, each of the projections is sufficiently stiff that, when pushed against the tubular frame, the one or more projections are capable collectively of applying, to the tubular frame, an axial pushing force of at least <NUM> N.

In an embodiment, when pushed against the tubular frame, the one or more projections are capable collectively of applying, to the tubular frame, an axial pushing force of at least <NUM> N and no more than <NUM> N.

In an embodiment, the tubular frame is disposed within the downstream capsule-portion of the capsule, and the downstream capsule-portion is retractable from over the tubular frame and at least the tip-portions, exposing, from the downstream capsule-portion, the tubular frame and at least the tip-portions.

In an embodiment, while the tubular frame and the tip-portions are exposed from the downstream capsule-portion, inflation of the balloon (i) radially expands the tubular frame, and (ii) deflects each of the projections radially outward within a respective radial plane on which the shaft-axis and the projection lie.

In an embodiment, while the tubular frame and the tip-portions are exposed from the downstream capsule-portion, inflation of the balloon uniformly fills the lumen of the tubular frame.

In an embodiment, a widest part of the balloon is disposed within the lumen.

In an embodiment, each projection has a radial stiffness in its radial plane, and has a lateral stiffness in a respective lateral plane, the lateral stiffness being greater than the radial stiffness.

In an embodiment, the downstream balloon-portion of the balloon extends away from the tubular frame, and is tapered.

In an embodiment, the upstream balloon-portion of the balloon extends away from the tubular frame, and is tapered.

In an embodiment, the tip-portion of each of the projections abuts the tubular frame, and the apparatus is configured such that the tip-portion of each of the projections remains in contact with the tubular frame as the balloon is inflated.

In an embodiment, a downstream end of the tubular frame defines a frame-circumference, the tip-portions define a projection-circumference, and while the tubular frame and the tip-portions are exposed from the downstream capsule-portion, inflation of the balloon increases the projection-circumference at the same rate as the balloon increases the frame-circumference.

In an embodiment, the tip-portion of each of the projections abuts the tubular frame.

In an embodiment, the projections are not attached to the tubular frame.

Also disclosed is apparatus for delivery of a prosthetic heart valve to an annulus of a native heart valve, the apparatus including:.

In an embodiment, for each of the projections:
the projection defines:.

In an embodiment, the apparatus further includes a tubular frame at the distal end of the shaft, the tubular frame defining a longitudinal lumen, and the balloon is disposed within the lumen.

In an embodiment, each of the projections is sufficiently stiff that it is capable of applying, to the tubular frame, an axial pushing force of at least <NUM> N.

In an embodiment, each of the projections is sufficiently stiff that the one or more projections are capable collectively of applying, to the tubular frame, an axial pushing force of at least <NUM> N.

In an embodiment, the apparatus further includes one or more prosthetic valve leaflets disposed within the lumen and coupled to the tubular frame.

In an embodiment, the balloon, in its inflated state, uniformly fills the lumen.

In an embodiment, in the inflated state of the balloon, the proximal portion of the balloon tapers proximally away from the tubular frame.

In an embodiment, the balloon, in its inflated state, has a tapered distal portion that tapers distally away from the tubular frame.

In an embodiment, the widest part of the balloon is disposed longitudinally between the proximal portion and the distal portion.

In an embodiment, each of the projections has a tip-portion that abuts a proximal surface of the tubular frame.

In an embodiment, the tip-portion of each of the projections is not attached to the tubular frame.

In an embodiment, inflation of the balloon simultaneously increases (i) a radial distance between the tip-portion of one of the projections and the tip-portion of an opposite one of the projections, and (ii) a circumference of the tubular frame.

Also disclosed is apparatus for use in a heart of a subject, the apparatus including:.

In an embodiment, the outer frame further includes an upstream support portion, shape-set to extend radially outward from the tubular frame.

In an embodiment, the flange is shape-set to extend radially outward from the tubular frame.

In an embodiment, the outer frame further includes an upstream support portion, upstream support portion is shape-set to extend radially outward from the tubular frame, and the flange is shape-set to extend radially outward from the tubular frame and toward the upstream support portion.

In an embodiment, the eyelet is an outer eyelet, and the tubular frame defines an inner eyelet, the shaft extending through the inner eyelet.

In an application, the shape-memory alloy is nickel titanium.

In an embodiment, the flange is one of a plurality of flanges, and the outer frame includes the plurality of flanges, and circumscribes the tubular frame.

In an embodiment, the eyelet is one of a plurality of eyelets, and the outer frame defines the plurality of eyelets.

In an embodiment, the flanges of the plurality of flanges are equal in number to the eyelets of the plurality of eyelets.

In an embodiment, the eyelet is one of a plurality of eyelets, and the root-portion of each flange of the plurality of flanges defines a respective eyelet of the plurality of eyelets.

Also disclosed is a method (not forming part of the present invention) for constructing a prosthetic heart valve, the method including:.

The method may further include shape-setting the flange to extend radially outward.

Cutting the outer frame may include cutting the outer frame such that the flange has a root-portion and a tip, and defines the eyelet at the root-portion, and
passing the shaft of the pin through the eyelet such that the head of the pin is disposed against the outer frame radially outward from the eyelet, includes passing the shaft of the pin through the eyelet such that the head of the pin is disposed against the root-portion of the flange, radially outward from the eyelet.

In a preferred embodiment of said method, the eyelet is an outer eyelet, and cutting the tubular frame includes cutting the tubular frame such that the tubular frame defines an inner eyelet, and the step of passing the shaft includes passing the shaft through the outer eyelet and through the inner eyelet, and welding the shaft to the tubular frame includes welding the shaft to the tubular frame at the inner eyelet. In a preferred embodiment of said method, the shape-memory alloy is nickel titanium, and cutting the outer frame from the tube of the shape-memory alloy includes cutting the outer frame from a tube of nickel titanium.

In a preferred embodiment of said method, the material is not a shape-memory material, and cutting the tubular frame includes cutting the tubular frame from the material that is not a shape-memory material.

In a preferred embodiment of said method, the material is steel, and cutting the tubular frame from the tube of the material includes cutting the tubular frame from a tube of steel. In a preferred embodiment of said method, the material is cobalt chrome, and cutting the tubular frame from the tube of the material includes cutting the tubular frame from a tube of cobalt chrome.

Cutting the outer frame may include cutting the outer frame that further includes an upstream support portion, optionally the method includes shape-setting the upstream support portion to extend radially outward.

In a preferred embodiment of said method, the flange is one of a plurality of flanges, cutting the outer frame includes cutting the outer frame such that the outer frame defines the plurality of flanges, and positioning the outer frame includes positioning the outer frame such that the outer frame circumscribes the tubular frame, optionally, the eyelet is one of a plurality of eyelets, and cutting the outer frame includes cutting the outer frame such that the outer frame defines the plurality of eyelets, optionally cutting the outer frame includes cutting the outer frame such that the outer frame has an equal number of flanges and eyelets.

Also disclosed is a method (not forming part of the present invention) for use at a native valve of a heart of a subject, the method including:
advancing, to the heart, an implant that includes a tubular frame, the tubular frame disposed on a distal portion of a tool, the distal portion of the tool including:.

Pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N to the tubular frame, optionally pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N, further optionally pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N, further optionally pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N or pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N. In said step of pushing with a distal pushing force of at least 40N and no more than 100N, pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N or pushing the projections distally against the tubular frame may comprise pushing the projections distally against the tubular frame such that the projections collectively apply a distal pushing force of at least <NUM> N and no more than <NUM> N.

According to a preferred embodiment of said method, the implant includes one or more self-expanding flanges, the tool distal portion of the tool includes a capsule; advancing the implant includes advancing the tubular frame while at least the flanges are disposed within, and constrained by, the capsule, the method further includes, prior to pushing the projections distally, allowing the flanges to self-expand by exposing the flanges from the capsule, and the step of pushing the projections distally against the tubular frame includes pushing the implant distally such that the flanges press against tissue of the native valve, optionally advancing the implant includes advancing the implant while the projections are disposed within the capsule, and exposing the flanges from the capsule includes retracting the capsule proximally with respect to the implant such that the flanges and the projections become exposed from the capsule.

Also disclosed is a method (not forming part of the invention) for use at a native valve of a heart of a subject, the method including:.

Plastically expanding the tubular frame may include plastically expanding the tubular frame by radially by inflating the balloon while continuing to press the flanges against the downstream surface.

Exposing the flanges from the downstream capsule-portion may include moving the downstream capsule-portion away from the upstream capsule-portion.

According to a preferred embodiment of said method, advancing the implant may include advancing the implant while the tubular frame is disposed within the downstream capsule-portion, and the method further includes exposing the tubular frame from the downstream capsule-portion.

Exposing the tubular frame from the downstream capsule-portion may include exposing the tubular frame from the downstream capsule-portion prior to the step of pressing the flanges.

Exposing the tubular frame from the downstream capsule-portion may include exposing the tubular frame entirely from the downstream capsule-portion without causing the tubular frame to expand.

According to a preferred embodiment of said method, the implant further includes a shape-memory upstream support portion, constrained within the upstream capsule-portion, and the method further includes, prior to expanding the tubular frame, exposing the upstream support portion from the upstream capsule-portion such that the upstream support portion automatically deflects radially outward, optionally moving the implant in the upstream direction includes moving the implant such that the upstream support portion, constrained within the upstream capsule portion, is disposed upstream of the native valve, and exposing the upstream support portion includes exposing the upstream support portion such that the upstream support portion automatically deflects radially outwards and contacts an upstream surface of the native valve.

According to a preferred embodiment of said method, the implant is compressed around a body balloon-portion of the balloon, the tool further includes one or more projections, each of the projections having a base-portion and a tip-portion, the projections extend, from the shaft, over at least a downstream balloon-portion of the balloon toward the tubular frame, such that the tip-portion of each of the projections is closer than its corresponding base-portion to the tubular frame, and pressing the flanges against the downstream surface by moving the implant in the upstream direction includes pushing the implant in the upstream direction by pushing the tip-portions against the tubular frame, further optionally expanding the tubular frame includes inflating the balloon such that (i) the body balloon-portion radially expands the tubular frame by pressing radially outward against the tubular frame, and (ii) the downstream balloon-portion deflects the projections radially outward by pressing radially outward against the projections or advancing the distal portion of the delivery tool includes advancing the distal portion of the delivery tool while the projections are disposed within the downstream capsule-portion, and the method further includes, prior to radially expanding the tubular frame, exposing at least the tips of the projections from the downstream capsule- portion, wherein the step of advancing the distal portion optionally comprises the step of exposing at least the tips of the projections from the downstream capsule-portion including exposing at least the tips of the projections from the downstream capsule-portion prior to pressing the flanges against the downstream surface of the native valve.

Also disclosed is a method (not forming part of the invention) for use at a native valve of a heart of a subject, the method including:
advancing, to the heart:
a distal portion of a delivery tool, the delivery tool including:.

Inflating the balloon to a further-inflated state may further include increasing the inter-flange distance.

According to a preferred embodiment of said method, exposing the flanges includes exposing the flanges while the flanges are positioned upstream of the native valve; and the method further includes, prior to pressing the flanges against the downstream surface of the native valve, moving the exposed flanges to be downstream of the native valve, optionally partially inflating the balloon includes partially inflating the balloon while the flanges are positioned upstream of the native valve.

Inflating the balloon to the further-inflated state may include inflating the balloon to the further-inflated state while continuing to press the flanges against the downstream surface.

Exposing the flanges from the capsule may include moving a downstream capsule-portion of the capsule away from an upstream capsule-portion of the capsule, optionally advancing the implant includes advancing the implant while the tubular frame is disposed within the downstream capsule-portion, and the method further includes exposing the tubular frame from the downstream capsule-portion, further optionally exposing the tubular frame from the downstream capsule-portion includes exposing the tubular frame from the downstream capsule-portion prior to pressing the flanges against the downstream surface of the native valve or exposing the tubular frame from the downstream capsule-portion includes exposing the tubular frame entirely from the downstream capsule-portion without causing the tubular frame to expand.

According to a preferred embodiment of said method, the implant further includes a shape-memory upstream support portion, constrained within the capsule, and the method further includes, subsequent to pressing the flanges against a downstream surface of the native valve, exposing the upstream support portion from the capsule such that the upstream support portion automatically deflects radially outward, optionally exposing the upstream support portion includes exposing the upstream support portion such that the upstream support portion contacts an upstream surface of the native valve.

According to a preferred embodiment of said method, advancing the implant disposed within the capsule, the tubular frame compressed around the balloon, includes.

Also disclosed is an apparatus for delivery of a prosthetic heart valve to an annulus of a native heart valve, the apparatus including:.

The present invention will be more fully understood from the following detailed description, taken together with the drawings, in which:.

Reference is made to Figs. lA-I, which are schematic illustrations of an implant <NUM>, in accordance with some applications of the invention.

Implant <NUM> comprises a tubular frame <NUM> that circumscribes a longitudinal axis ax l to define a lumen <NUM> along axis ax l. Implant <NUM> typically further comprises at least one valve member (e.g., prosthetic leaflet <NUM>) (<FIG>), disposed within lumen <NUM>, and coupled to frame <NUM>. Therefore implant <NUM> typically comprises or serves as a prosthetic valve <NUM>.

Implant <NUM> further comprises an outer frame <NUM> and one or more pins <NUM>. Outer frame <NUM> is disposed radially outward from tubular frame <NUM>, comprises one or more flanges <NUM>, and defines one or more eyelets, e.g., outer eyelets <NUM>. Typically, frame <NUM> comprises a plurality of flanges (e.g., <NUM>-<NUM>, such as <NUM>-<NUM>, such as <NUM>-<NUM> flanges). Typically, frame <NUM> defines a plurality of eyelets <NUM> (e.g., <NUM>-<NUM>, such as <NUM>-<NUM>, such as <NUM>-<NUM> eyelets). For some embodiments, the number of eyelets <NUM> is equal to the number of flanges. Further typically,the number of pins <NUM> is equal to the number of eyelets <NUM>. In the embodiment shown, there are <NUM> eyelets, <NUM> flanges, and <NUM> pins.

Typically, and as shown, frame <NUM> circumscribes tubular frame <NUM>. For example, frame <NUM> may comprise at least one ring <NUM> that circumscribes tubular frame <NUM>, and to which flanges <NUM> are coupled. Ring <NUM> typically defines alternating peaks and troughs, e.g., being zigzag or wavy in shape.

Typically, tubular frame <NUM> also defines one or more eyelets, e.g., inner eyelets <NUM>. Typically, frame <NUM> defines a plurality of eyelets <NUM> (e.g., <NUM>-<NUM>, such as <NUM>-<NUM>, such as <NUM>-<NUM> eyelets). Typically, the number of eyelets <NUM> is equal to the number of eyelets <NUM>.

Outer frame <NUM> is composed of a shape-memory alloy such as nickel titanium (e.g., Nitinol), whereas tubular frame <NUM> and pins <NUM> are composed of a material that is not the shape-memory alloy. That is, frame <NUM> and pins <NUM> are both composed of the same material, and that material is not the shape-memory alloy of which frame <NUM> is composed. Typically, the material of which frame <NUM> and pins <NUM> are composed is not a shape-memory material of any kind. For example, frame <NUM> and pins <NUM> may be composed of steel (e.g., stainless steel, such as 316LVM) or a cobalt chrome alloy (e.g., MP35N or L605). It is to be noted that throughout this patent application (including the specification and the claims) the term "composed of" x means that xis the primary substance from which an element is made, such that x confers its properties on the element that is made of x.

Pins <NUM> couple outer frame <NUM> to tubular frame <NUM>. Each pin <NUM> defines a shaft <NUM> and a head <NUM>. Shaft <NUM> is passed radially-inwardly through an eyelet <NUM> to tubular frame <NUM>, such that head <NUM> is disposed against outer frame <NUM>, radially outward from the eyelet <NUM>. Shaft <NUM> is welded to tubular frame <NUM>. Typically, shaft <NUM> is also passed radially inwardly through a respective eyelet <NUM>, and is welded to tubular frame <NUM> at eyelet <NUM>. Because pin <NUM> and frame <NUM> are both composed of the same material, they may be welded together. In contrast, frame <NUM> is composed of a different material than pin <NUM>, and coupling therebetween is provided by head <NUM>, which is larger than eyelet <NUM>.

Typically, each flange <NUM> has a root-portion <NUM> and a tip <NUM>, and extends away from the tubular frame from the root-portion to the tip. Each outer eyelet <NUM> is typically defined at (e.g., by) the root-portion <NUM> of a respective flange <NUM>, e.g., such that the head <NUM> of the respective pin <NUM> is disposed against the root-portion of the flange, radially outward from the eyelet.

Typically, frame <NUM> is cut from a tube of the shape-memory alloy. Typically, frame <NUM> is cut (e.g., laser cut) from a tube of the other material. In order to facilitate implant <NUM> serving as a prosthetic heart valve, lumen <NUM> is typically lined with a lining <NUM> (e.g., comprising a fabric), and a plurality of prosthetic leaflets <NUM> (e.g., comprising bovine pericardium) are secured within the lumen, e.g., by suturing the leaflets to lining <NUM> and/or25 to frame <NUM>. For the sake of clarity, lining <NUM>, leaflets <NUM>, and other fabric elements are omitted in Figs.

Typically, and as shown, implant <NUM> further comprises an upstream support portion <NUM>, e.g., comprising a plurality of radial arms <NUM> optionally covered in an annular sheet. Further typically, it is outer frame <NUM> that defines upstream support portion <NUM>, and therefore the upstream support portion is also composed of the shape-memory alloy. Flanges <NUM> extend radially outward from tubular frame <NUM>, and toward upstream support portion <NUM>. As discussed in more detail hereinbelow, flanges <NUM> are configured to engage a downstream surface of a native heart valve, and upstream support portion is configured (e.g., shaped and/or dimensioned) to be placed against an upstream surface of the native heart valve.

Frame <NUM> is shaped and memory-set such that, when unconstrained, upstream support portion <NUM> and flanges <NUM> extend radially outward from tubular frame <NUM>. Typically, when unconstrained, flanges <NUM> are arranged in an array <NUM> around the outside of tubular frame <NUM>, the array defining an inter-flange distance D58. Although inter-flange distance D58 is shown in Fig. IG as a distance between opposing flanges <NUM>, in some embodiments the inter-flange distance may refer to an alternative measurement (e.g., a distance between adjacent flanges <NUM>). As discussed hereinbelow (e.g., with reference to <FIG>), implant <NUM> is delivered while radially compressed (i.e., "crimped"), with upstream support portion <NUM> and flanges <NUM> constrained within a capsule. Because frame <NUM> is composed of the shape-memory alloy, upon being exposed from the capsule upstream support portion <NUM> and flanges <NUM> automatically deflect radially outward. In contrast, although tubular frame <NUM> is also radially compressed during delivery, it retains its radially-compressed state upon being exposed from the capsule, and is subsequently plastically-expanded, e.g., using a balloon. Typically, in the absence of frame <NUM>, frame <NUM> (e.g., ring <NUM>) would automatically radially expand upon being exposed from the capsule. However, because frame <NUM> is coupled to frame <NUM> (e.g., via pins <NUM>), frame <NUM> inhibits frame <NUM> (e.g., ring <NUM> thereof) from radially expanding until frame <NUM> is plastically expanded. That is, despite the elasticity of frame <NUM>, frame <NUM> is typically sufficiently rigid to inhibit frame <NUM> from automatically radially expanding upon5 exposure from the capsule. Similarly, the elasticity of frame <NUM> is typically insufficient to pull frame <NUM> into its radially expanded state (i.e., the state in which implant <NUM> functions as a prosthetic valve).

Reference is made to <FIG>, which are schematic illustration of a tool <NUM>, in accordance with some embodiments of the invention. For some embodiments, tool <NUM> is used to implant implant <NUM> at the native valve (e.g., as described with reference to <FIG>).

Tool <NUM> comprises a shaft <NUM>, a capsule <NUM>, and a balloon <NUM>, which is typically a non-compliant balloon. Shaft <NUM> has a central longitudinal shaft-axis ax2, which typically is the same as, or is collinear with, a central longitudinal axis of tool <NUM>. Capsule <NUM> is disposed at a distal portion <NUM> of the tool (e.g., at a distal end of shaft <NUM>), and comprises an upstream capsule-portion <NUM> and a downstream capsule-portion <NUM>, and is openable by moving the upstream capsule-portion and the downstream capsule-portion apart. Balloon <NUM> is coupled to shaft <NUM>, and is disposed within capsule <NUM> (e.g., downstream capsule-portion <NUM> thereof). As shown, tool <NUM> typically comprises a controller and/or handle <NUM> at a proximal portion I02 of the tool.

<FIG> shows tool <NUM> in a closed state, with capsule-portions <NUM> and <NUM> close to each other (e.g., in contact with each other). <FIG> shows tool <NUM> in an open state, after capsule <NUM> has been opened by retracting capsule-portion <NUM> away from capsule-portion <NUM>. <FIG> shows a longitudinal cross-section of <FIG> shows the same longitudinal cross-section as <FIG>, but with balloon <NUM> inflated. For clarity, implant <NUM> is not shown in <FIG>.

As described hereinabove, outer frame <NUM> of implant <NUM> is composed of a shape-memory alloy. Flanges <NUM> are shape-set to protrude radially outward. Upstream support portion <NUM> is (e.g., arms <NUM> thereof are) also shape-set to protrude radially outward. As described in more detail with reference to <FIG>, flanges <NUM> and upstream support portion <NUM> are disposed within, and constrained radially inward by, capsule <NUM> during delivery. For example, flanges <NUM> are constrained by downstream capsule-portion <NUM> (e.g., constrained within the downstream capsule-portion), and upstream support portion <NUM> is constrained by upstream capsule-portion <NUM> (e.g., constrained within the upstream capsule-portion). For delivery of implant <NUM>, tubular frame <NUM> is compressed around balloon <NUM>, which will eventually be used to radially expand the tubular frame. Typically, during delivery tubular frame <NUM> is disposed within downstream capsule-portion <NUM>. Therefore, in preparation for implantation of implant <NUM>, an operator typically compresses (e.g., "crimps") tubular frame <NUM> around balloon <NUM>, radially compresses and at least partly encapsulates flanges <NUM> within downstream capsule-portion <NUM>, and radially compresses and at least partly encapsulates upstream support portion <NUM> (e.g., arms <NUM> thereof) within upstream capsule-portion <NUM>.

In the delivery state of the apparatus, balloon <NUM> is typically disposed within capsule <NUM>, flanges <NUM> are typically constrained within downstream capsule-portion <NUM>, and upstream support portion <NUM> is typically constrained within upstream capsule-portion <NUM>. For some embodiments, the term "within" means "entirely within," i.e., with no part of the balloon, flange, or upstream support portion disposed outside of the capsule or capsule-portion. For some embodiments, the term "within" means "at least partly within," i.e., part of the balloon, flange, or upstream support portion may be disposed outside of the capsule or capsule-portion.

Balloon <NUM> has an upstream (e.g., distal) balloon-portion <NUM>, a downstream (e.g., proximal) balloon-portion <NUM>, and a body (e.g., intermediary) balloon-portion <NUM> therebetween. Body balloon-portion <NUM> typically comprises the widest part of balloon <NUM>. Typically, body balloon-portion <NUM> is disposed within lumen <NUM> of tubular frame <NUM>. That is, for delivery, tubular frame <NUM> is typically compressed around body balloon-portion <NUM>. As shown in <FIG>, when inflated, body balloon-portion <NUM> is typically cylindrical, and balloon-portions <NUM> and <NUM> typically taper away from the body balloon-portion and from tubular frame <NUM>. For example, balloon-portions <NUM> and <NUM> may be conical or hemispherical.

Typically, balloon <NUM> is fixed to shaft <NUM>, e.g., by at least one end of the balloon being attached to the shaft. For example, and as shown, balloon-portion <NUM> may be attached to shaft <NUM>. Tool <NUM> defines an inflation channel <NUM> from proximal portion <NUM> to distal portion <NUM>. For some embodiments, and as shown, tool <NUM> comprises a pipe <NUM> through which shaft <NUM> extends, and channel <NUM> is defined between the pipe and the channel. For such applications, balloon-portion <NUM> of balloon <NUM> is typically attached to pipe <NUM>, placing balloon <NUM> in fluid communication with channel <NUM> such that the balloon is inflatable via the channel.

Typically, pipe <NUM> is fixed with respect to shaft <NUM>. However, both upstream capsule-portion <NUM> and downstream capsule-portion <NUM> are typically axially movable with respect to shaft <NUM>, such as by one of the capsule-portions being attached to a rod <NUM> that is slidable through the shaft, and the other one of the capsule-portions being attached to a tube (not shown) that is slidable over the shaft. For example, and as shown, capsule-portion <NUM> may be attached to rod <NUM>, and capsule-portion <NUM> may be attached to the tube. Upstream capsule-portion <NUM> is retractable from over upstream support portion <NUM> by being moved away from balloon <NUM> (i.e., in an upstream direction), and downstream capsule-portion <NUM> is retractable from over flanges <NUM> by being moved away from the balloon (i.e., in a downstream direction).

Typically, tool <NUM> compnses one or more (typically a plurality of) elongate projections <NUM>. Projections <NUM> are configured to apply an axial pushing force against implant <NUM> (e.g., tubular frame <NUM> thereof), in order to maintain the positioning of the implant during deployment. For example, and as described in more detail with reference to <FIG>, after flanges <NUM> are exposed and allowed to expand, the flanges may be pushed and held against a downstream surface of the native valve (e.g., leaflets thereof), typically until balloon <NUM> is at least partly inflated. Typically, each of projections <NUM> is sufficiently stiff (e.g., axially stiff) that, when pushed against tubular frame <NUM>, it is capable of applying an axial pushing force of at least <NUM> N, e.g., at least <NUM> N, such as at least <NUM> N - e.g., without the projection buckling. For example, each projection <NUM> may be capable of applying a pushing force of <NUM>-<NUM> N, e.g., <NUM>-<NUM> N (e.g., <NUM>-<NUM> N) or <NUM>-<NUM> N (e.g., <NUM>-<NUM> N, e.g., <NUM>-<NUM> N, such <NUM>-<NUM> Nor <NUM>-<NUM> N). Typically, projections <NUM> are collectively capable of applying an axial pushing force of at least <NUM> N, (e.g., at least <NUM> N, e.g., at least <NUM> N, e.g., at least <NUM> N, such as at least <NUM> N) to tubular frame <NUM> - e.g., without the projection buckling. For example, projections <NUM> may be collectively capable of applying a pushing force of <NUM>-<NUM> N e.g., <NUM>-<NUM> N (e.g., <NUM>-<NUM> N) or <NUM>-<NUM> N (e.g., <NUM>-<NUM> Nor <NUM>-<NUM> N). For clarity, these axial pushing force values are as measured with the projection or projections aligned parallel to axis axl.

During delivery (i.e., in a delivery state of tool <NUM> and implant <NUM>), projections <NUM> are typically disposed within downstream capsule-portion <NUM>. Each projection <NUM> has a tip-portion (e.g., a free end) <NUM>, and a base-portion <NUM>. Base-portion <NUM> is disposed deeper into the downstream capsule-portion than is tip-portion <NUM>. Projections <NUM> are arranged circumferentially around shaft-axis ax2, such that tip-portions <NUM> are arranged circumferentially around balloon-portion <NUM> of balloon <NUM>, with the tip-portion of each projection being closer than its corresponding base-portion <NUM> to tubular frame <NUM>. Typically, in the delivery state, tip-portions <NUM> abut tubular frame <NUM> (e.g., a proximal and/or downstream surface thereof). However, projections <NUM> (e.g., tip-portions <NUM> thereof) are typically not attached to tubular frame <NUM>. Therefore, after expansion of tubular frame <NUM> and deflation of balloon <NUM> (e.g., as described with reference to <FIG>), projections <NUM> can be withdrawn without actively disengaging them from the tubular frame.

Tool <NUM> is typically configured to facilitate continued application, by projections <NUM>, of the axial pushing force against tubular frame <NUM> while the tubular frame is being expanded, despite the presence of tapered balloon-portion <NUM>. This feature, and its advantages, are discussed in more detail hereinbelow with reference to <FIG>, <FIG>. Once tubular frame <NUM> and tip-portions <NUM> are exposed from downstream capsule-portion <NUM>, inflation of balloon <NUM> both (i) radially expands the tubular frame (e.g., by body balloon-portion <NUM> pressing radially outward against the tubular frame), and (ii) deflects each of projections <NUM> radially outward (e.g., by balloon-portion <NUM> pressing radially outward against the projection).

The apparatus may be configured such that projections <NUM> deflect simultaneously and/or at the same rate that the tubular frame expands, allowing contact between the projections and the tubular frame to be maintained. For example, tubular frame <NUM> may define a frame-circumference, the tip-portions may collectively define a projection-circumference, and while the tubular frame and the tip-portions are exposed from the downstream capsule-portion, inflation of balloon <NUM> may increase the projection-circumference at the same rate as it increases the frame-circumference.

Each projection <NUM> is therefore sufficiently flexible (e.g., radially flexible) that it is deflected by a radial force Fl applied by the radial expansion of balloon-portion <NUM>. Nonetheless, as described hereinabove, each projection <NUM> is also typically capable of applying an axial pushing force F2 of at least <NUM> N to tubular frame <NUM> (e.g., to overcome an axial resistance force F3, of frame <NUM> against the projections, in the opposite direction of force F2). Forces Fl, F2, and F3 are indicated in <FIG>.

For some embodiments of the invention, this configuration is facilitated by each projection <NUM> being non-isometrically flexible. For example, each projection <NUM> may have a radial stiffness in its radial plane <NUM>, and a lateral stiffness in its lateral plane <NUM>, the lateral stiffness being greater than (e.g., more than twice as great as) the radial stiffness. For clarity, radial plane <NUM> is a plane on which the projection and axis ax2 lie, and in which the projection deflects, and lateral plane <NUM> is typically transverse to the radial plane. Lateral plane <NUM> may also be tangential to the projection-circumference collectively defined by the tip-portions of projections <NUM>.

For some embodiments of the invention, outward radial force Fl is of a greater magnitude than axial resistance force F3. It is hypothesized by the inventors that, for at least some such applications of the invention, Fl being greater than F3 facilitates deflection of projections <NUM> simultaneously with the projections axially pushing tubular frame <NUM>.

For some embodiments, and as shown, tip-portions <NUM> are shaped to define a face that has a greater transverse cross-sectional area than parts of projection <NUM> that are closer to base-portion <NUM>. These faces are visible in <FIG>. The difference in transverse cross-sectional area may be understood by comparing the element labeled "<NUM>" in the lower cross-section of <FIG>, with the element labeled "<NUM>, <NUM>" in the upper cross-section of <FIG>. It is hypothesized by the inventors that, due to their greater transverse cross-sectional area, these faces facilitate application of the axial pushing force to tubular frame <NUM>.

Reference is now made to <FIG> which are schematic illustrations showing tool <NUM> being used to deliver implant <NUM> to a native valve <NUM> of a heart <NUM> of a subject. Although <FIG> show a percutaneous transapical approach, it is to be noted that other percutaneous approaches may be used, such as transatrial, or transluminal (e.g., transfemoral), mutatis mutandis. Although <FIG>show valve <NUM> as being a mitral valve, it is to be noted that the native valve may be a tricuspid valve, an aortic valve, or a pulmonary valve, mutatis mutandis.

While tool <NUM> and implant <NUM> are in the delivery state (e.g., with capsule <NUM> closed, and implant <NUM> compressed therewithin), tool <NUM> is transapically advanced into left ventricle <NUM> (<FIG>). As shown, tool <NUM> is positioned (e.g., facilitated by fluoroscopy) such that capsule-portion <NUM> is disposed between native leaflets <NUM> of valve <NUM>. Capsule-portion <NUM> is then retracted, in a downstream direction, away from capsule- portion <NUM>, exposing (i) at least flanges <NUM> of implant <NUM>, and (ii) at least tip-portions <NUM> of projections <NUM> (<FIG>). Flanges <NUM> automatically deflect radially outward upon becoming exposed. Typically, and as shown in the inset of <FIG>, flanges <NUM> are arranged in array <NUM> around the outside of tubular frame <NUM>, the array defining inter-flange distance D58. Typically, this step also exposes tubular frame <NUM> from capsule-portion <NUM>. As described hereinabove, tubular frame <NUM> typically does not expand upon becoming exposed from capsule-portion <NUM>.

<FIG> includes two cross-sections. The upper cross-section is at the level of contact between projections <NUM> and implant <NUM>, and therefore shows tip-portions <NUM> of the projections arranged circumferentially around uninflated balloon <NUM>, through which shaft <NUM> extends. The lower cross-section is further downstream/proximal, closer to base-portions <NUM> of projections <NUM>. The lower cross-section also shows, for one projection <NUM>, a radial plane <NUM> and a lateral plane <NUM>. As described hereinabove, radial plane <NUM> is a plane on which projection <NUM> and axis axl lie, and in which the projection deflects, and lateral plane <NUM> is typically transverse to the radial plane.

Flanges <NUM> are subsequently pressed against a downstream surface of native valve <NUM> by moving implant <NUM> in an upstream direction (<FIG>). This is performed by applying, via projections <NUM>, the axial pushing force described hereinabove. Typically, flanges <NUM> are pressed against leaflets <NUM> of the native valve.

As shown in <FIG>, for embodiments in which prosthetic valve <NUM> compnses upstream support portion <NUM>, this movement of implant <NUM> includes placing the upstream support portion, constrained by capsule-portion <NUM>, upstream of native valve <NUM> (i.e., into left atrium <NUM>). For such embodiments, projections <NUM> typically facilitate retention of upstream support portion <NUM> within capsule-portion <NUM> by obstructing implant <NUM> from moving axially away from the capsule-portion.

Subsequently, upstream support portion <NUM> is exposed from capsule-portion <NUM> and automatically deflects radially outward, e.g., contacting an upstream surface of native valve <NUM> (<FIG>).

While flanges <NUM> remain in contact with the downstream surface of the native valve, and typically while upstream support portion <NUM> remains in contact with the upstream surface of the native valve, tubular frame <NUM> is plastically expanded radially by inflating balloon <NUM> (<FIG>). For some embodiments, this is performed while continuing to press flanges <NUM> against the downstream surface using projections <NUM>. As described hereinabove, projections <NUM> are configured to deflect radially outwardly as tubular frame <NUM> expands upon inflation of balloon <NUM>, and therefore (i) do not inhibit radial expansion of the balloon, and (ii) facilitate optional continued application of the axial pushing force during inflation of the balloon.

After implant <NUM> has been implanted and expanded, balloon <NUM> is deflated, and tool <NUM> is removed from the subject, typically after closing capsule <NUM> (<FIG>).

Reference is now made to <FIG>, <FIG>, which are schematic illustrations of implant-delivery tools <NUM>, <NUM>, and <NUM>, in accordance with some embodiments of the invention. In <FIG>, <FIG> a generic expandable implant <NUM> is shown being implanted using the respective tool. For some embodiments, implant <NUM> may represent tubular frame <NUM> of implant <NUM>.

<FIG> show tool <NUM> being used with implant <NUM>, e.g., as described hereinabove for implant <NUM>. The states of tool <NUM> in <FIG> generally correspond to the state of tool <NUM> in <FIG>, respectively, except that in <FIG> implant <NUM> is shown. That is, (i) <FIG> shows implant <NUM> disposed around body balloon-portion <NUM> of balloon <NUM>, with downstream capsule-portion <NUM> having been withdrawn, and balloon <NUM> not yet inflated, and (ii) <FIG> shows balloon <NUM> having been inflated. <FIG> show the same states (e.g., the same steps of deployment) for tools <NUM> and <NUM>.

Tool <NUM> is identical to tool <NUM>, except that it comprises projections <NUM> instead of projections <NUM>. Projections <NUM> are identical to projections <NUM>, except that they are more rigid. Projections <NUM> are identical to projections <NUM> except that they are shorter, and therefore do not extend over balloon-portion <NUM> to implant <NUM>. (Projections <NUM> may be flexible like projections <NUM> or rigid like projections <NUM>. ) As described hereinabove, tool <NUM> is typically configured to facilitate continued application, by projections <NUM>, of the axial pushing force against tubular frame <NUM> while the tubular frame is being expanded, despite the presence of tapered balloon-portion <NUM>. The advantage conferred by projections <NUM> may be illustrated by the following comparison of the results of using tool <NUM> and/or tool <NUM>, to the result of using tool <NUM>.

As described hereinabove, body balloon-portion <NUM> is typically cylindrical, and balloon-portions <NUM> and <NUM> typically taper away from the body balloon-portion. A balloon of this shape advantageously can withstand a greater inflation pressure than can a similar balloon that is entirely cylindrical (i.e., with flat ends). However, in order to expand implant <NUM> evenly, the implant is disposed around body balloon-portion <NUM>, which is cylindrical when inflated.

Before inflation of balloon <NUM>, there is no difference between using tool <NUM> and using tool <NUM>. When balloon <NUM> of tool <NUM> is inflated, projections <NUM> are pushed radially outward by the balloon, allowing downstream balloon-portion <NUM> (over which the projections are disposed) to assume its conical shape, and body balloon-portion <NUM> to assume its cylindrical shape, thereby evenly expanding implant <NUM>. When inflated, balloon <NUM> typically fills the lumen of implant <NUM> uniformly.

In contrast, when balloon <NUM> of tool <NUM> is inflated, projections <NUM> are not pushed radially outward by the balloon, and instead constrain balloon-portion <NUM> (over which the projections are disposed) from expanding. Therefore, a downstream region 124a of body balloon-portion <NUM> is inhibited from fully inflating and joining the rest of the body balloon-portion in becoming cylindrical. Therefore, the part of implant <NUM> that is disposed around region 124a is not expanded to the same degree as other parts of the implant. That is, implant <NUM> is not expanded evenly.

Projections <NUM> of tool <NUM> do not extend over balloon-portion <NUM> to implant <NUM>, and therefore do not constrain balloon-portion <NUM> from expanding. However, because they do not reach implant <NUM>, they are unable to serve the function of applying the axial force to the implant in order to correctly position the implant during implantation. Furthermore, in some instances, implant <NUM> may slip with respect to balloon <NUM> and become positioned over conical balloon-portion <NUM> or <NUM>, which, as described hereinabove, may result in uneven expansion of the implant.

Therefore, the particular quality of projections <NUM> to be both (i) sufficiently rigid to apply the axial force to an implant, and (ii) sufficiently radially flexible to be pushed radially outward by balloon <NUM>, provides tool <NUM> with the ability to both (i) control the position of an implant, and (ii) to evenly expand the implant.

Reference is made to <FIG>and <FIG>, which are schematic illustrations of additional embodiments of implant-delivery tool <NUM> being used to deliver implant <NUM> to a native valve <NUM> of a heart <NUM> of a subject, in accordance with some embodiments of the invention. In such embodiments, balloon <NUM> is configured to be expandable to at least (i) a partially-inflated state and (ii) a further-inflated state. For example, proximal portion <NUM> of tool <NUM> (e.g., controller/handle <NUM>) may be configured to inflate balloon <NUM> to a distinct partially-inflated state, and may be further configured to inflate balloon <NUM> to a further-inflated state. It is hypothesized by the inventors that regulated inflation of balloon <NUM>, such that the balloon may be maintained in the partially-inflated state, may facilitate some applications of tool <NUM>, as described hereinbelow. Since such embodiments share similarities with those described above in reference to <FIG>, the following description will focus upon aspects differentiating between them and the embodiments described hereinabove in reference to <FIG>.

Although <FIG> and <FIG> show a transapical approach to a native mitral valve, these embodiments of the invention may also be modified as necessary to accommodate alternate approaches to a mitral or other native heart valve, mutatis mutandis. <FIG> shows tool advanced while implant <NUM> is disposed within capsule <NUM>, from which the implant is later exposed. Typically, and as shown in <FIG>, flanges <NUM> deflect automatically radially outward upon exposure from capsule <NUM>, whereas tubular frame <NUM> typically does not expand upon being partially or entirely exposed from the capsule. Further typically, and as shown, capsule <NUM> comprises upstream capsule-portion <NUM> and downstream capsule-portion <NUM>, and flanges <NUM> are exposed from the capsule by moving the downstream capsule-portion away from the upstream capsule-portion. Further typically, flanges <NUM> are (i) exposed from the downstream capsule-portion and (ii) arranged in array <NUM> around the outside of tubular frame <NUM>, before the flanges are pressed against the downstream surface of the native valve <NUM>.

For some embodiments, it may be desirable to at least partially expand tubular frame and/or array <NUM> of flanges <NUM>, prior to the flanges contacting the downstream surface of native valve <NUM>. <FIG> shows inflation of balloon
<NUM> to the partially-inflated state, before flanges <NUM> contact the surface of the native valve <NUM>. Inflation of balloon <NUM> to the partially-inflated state enacts, inter alia, (i) partial radial expansion of tubular frame <NUM>, and/or (ii) partial increasing of inter-flange distance D58 defined by array <NUM>. <FIG> shows pressing of flanges <NUM> against a downstream surface of the native valve <NUM> by moving implant <NUM> in an upstream direction, while inter-flange distance D58 remains partially increased. Typically, and as shown, this is achieved by moving the implant in the upstream direction while balloon <NUM> remains in the partially-inflated state. In this way, partial inflation of balloon <NUM> may enable flanges to reach further laterally while contacting the downstream surface of native valve <NUM>. It is hypothesized by the inventors that increasing inter-flange distance D58 defined by array <NUM>, before flanges <NUM> press against the downstream surface, may facilitate capture of the tissue of native valve <NUM> (e.g., native leaflets <NUM>) - e.g., increasing an amount of the tissue eventually captured between flanges <NUM> and upstream support portion <NUM>.

Subsequently, upstream support portion <NUM> is exposed from capsule <NUM> while flanges <NUM> remain in contact with the downstream surface (e.g., continue to press against the downstream surface), while inter-flange distance D58 remams partially increased, and typically while balloon <NUM> remains partially inflated (<FIG>). This may be analogous to the step shown in <FIG>, but with inter-flange distance D58 partially increased, and balloon <NUM> typically being partially inflated.

Subsequently, balloon <NUM> is further inflated to the further-inflated state further radially expanding tubular frame <NUM> (<FIG>). For some applications, this also further increases inter-flange distance D58 by expanding array <NUM>. That is, further inflation of balloon <NUM> may enable the flanges to reach further laterally than when balloon <NUM> is in the partially-inflated state.

<FIG>show subsequent deflation of balloon <NUM> and withdrawal of tool <NUM>, e.g., analogous to <FIG>, mutatis mutandis.

For some embodiments, it may be desirable to expose flanges <NUM> from capsule <NUM> and/or at least partially expand array <NUM>, while the flanges are disposed upstream of the native valve <NUM> (e.g., within atrium <NUM>), and to subsequently move the flanges downstream of the native valve (e.g., within ventricle <NUM>) while the flanges remain in this state. <FIG> relate to such applications.

<FIG> shows exposure of flanges disposed upstream of native valve <NUM>, in accordance with some applications of the invention. Prior to this, tool <NUM> is typically positioned within the heart such that the flanges are disposed, within capsule <NUM>, upstream of the native valve.

For some embodiments, and as shown in <FIG>, balloon <NUM> is then inflated to the partially-inflated state, while flanges <NUM> remain disposed upstream of native valve <NUM>.

Subsequently, tool <NUM> is moved downstream (proximally, for a transapical approach) until the leaflets are observed (e.g., using fluoroscopy and/or ultrasound) to coapt upstream of flanges <NUM> (<FIG>). It is hypothesized by the inventors that this reduces how far downstream the flanges become disposed while deployed. That is, the position of implant <NUM> at which the leaflets coapt upstream of the flanges represents the minimal depth into the ventricle that the flanges are required to reach in order to subsequently ensnare the leaflets. This therefore reduces the distance that the deployed flanges must be moved in an upstream direction when subsequently engaging the leaflets. It is hypothesized by the inventors that this reduces the likelihood of inadvertently or prematurely ensnaring tissue such as chordae tendineae, which might otherwise occur if the deployed flanges were deeper within the ventricle, and therefore moved a greater distance, while in their deployed state, upstream through the ventricle. Similar techniques are described, mutatis mutandis, in <CIT>et al. and <CIT>et al.

Claim 1:
Apparatus for use at a native valve of a heart of a subject, the apparatus comprising:
a delivery tool (<NUM>), comprising:
a shaft (<NUM>), having a shaft-axis;
a capsule (<NUM>), disposed at a distal portion (<NUM>) of the tool, and comprising an upstream capsule-portion (<NUM>) and a downstream capsule-portion (<NUM>), the capsule being openable by moving the upstream capsule-portion and the downstream capsule-portion apart; and
a balloon (<NUM>), coupled to the shaft, and disposed within the capsule; and
a prosthetic valve (<NUM>), comprising:
a tubular frame (<NUM>) that circumscribes a longitudinal axis to define a lumen (<NUM>) along the longitudinal axis, that is compressed around the balloon, and that is disposed within the capsule; and
an outer frame (<NUM>) coupled to the tubular frame, the outer frame comprising:
one or more shape-memory flanges (<NUM>), constrained within the downstream capsule-portion configured to engage a downstream surface of a native heart valve; and
a shape-memory upstream support portion (<NUM>) configured to be placed against an upstream surface of a native heart valve, constrained within the upstream capsule-portion,
wherein:
the flanges are configured to automatically deflect radially outward from the tubular frame upon exposure from the downstream capsule-portion,
the upstream support portion is configured to automatically deflect radially outward upon exposure from the upstream capsule-portion,
the tubular frame is configured to remain compressed around the balloon upon exposure of the tubular frame from the capsule,
the outer frame is disposed radially outward from the tubular frame, and
while the tubular frame is exposed from the capsule:
the tubular frame is configured to inhibit the outer frame from radially expanding, prior to inflation of the balloon, and
inflation of the balloon plastically expands the tubular frame radially.