Patent Description:
A wide range of medical treatments are known that utilize "endoluminal prostheses. " As used herein, endoluminal prostheses are intended to include medical devices that are adapted for temporary or permanent implantation within a body lumen, including both naturally occurring and artificially made lumens. Examples of lumens in which endoluminal prostheses may be implanted include but are not limited to arteries, veins, gastrointestinal tract, biliary tract, urethra, trachea, hepatic and cerebral shunts, and fallopian tubes.

Stent prostheses are known for implantation within a body lumen for providing artificial radial support to the wall tissue that defines the body lumen. To provide radial support to a blood vessel, such as one that has been widened by a percutaneous transluminal coronary angioplasty, commonly referred to as "angioplasty," "PTA" or "PTCA", a stent may be implanted in conjunction with the procedure. Under this procedure, the stent may be collapsed to an insertion diameter and inserted into the vasculature at a site remote from the diseased vessel. The stent may then be delivered to the desired treatment site within the affected vessel and deployed, by self-expansion or radial expansion, to its desired diameter for treatment.

Recently, flexible prosthetic valves supported by stent structures that can be delivered percutaneously using a catheter-based delivery system have been developed for heart and venous valve replacement. These prosthetic valves may include either self-expanding or balloon-expandable stent structures with valve leaflets disposed within the interior of the stent structure. The prosthetic valve can be reduced in diameter, by being contained within a sheath component of a valve delivery system or by crimping onto a balloon catheter, and advanced through the venous or arterial vasculature. Once the prosthetic valve is positioned at the treatment site, for instance within an incompetent native or previously implanted prosthetic valve, the stent structure may be expanded to hold the prosthetic valve firmly in place. One embodiment of a prosthetic valve having a stent structure is disclosed in <CIT>. entitled "Percutaneous Placement Valve Stent".

A human heart includes two atrio-ventricular valves through which blood flows from the atria to the ventricles, the valves functioning to prevent return of blood to the atrium. The tricuspid valve, also known as the right atrioventricular valve, is a tri-flap valve located between the right atrium and the right ventricle. The mitral valve, also known as the bicuspid or left atrioventricular valve, is a dual-flap valve located between the left atrium and the left ventricle, and serves to direct oxygenated blood from the lungs through the left side of the heart and into the aorta for distribution to the body. As with other valves of the heart, the mitral valve is a passive structure in that it does not itself expend any energy and does not perform any active contractile function. The mitral valve includes two moveable leaflets, an anterior leaflet and a posterior leaflet, that each open and close in response to differential pressures on either side of the valve. Ideally, the leaflets move apart from each other when the valve is in an open position, and meet or "coapt" when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with mitral regurgitation or backflow typically having relatively severe physiological consequences to the patient.

Chordae tendineae extend within the left ventricle between the native leaflets of the mitral valve and the papillary muscles. Chordae tendineae are cord-like tendons that connect the medial papillary muscle to the posterior leaflet of the mitral valve and connect the lateral papillary muscle to the anterior leaflet of the mitral valve. One method of delivering a mitral valve prosthesis includes delivery via a transapical approach directly through the apex of the heart via a thoracotomy. However, during such a transapical approach, the chordae tendineae may act as an obstacle within the delivery pathway. Chordae tendineae are not all aligned the same way making the delivery pathway to the mitral valve more challenging. The valve delivery system may become entangled in chordae tendineae during advancement, thereby restricting movement of the valve delivery system within the anatomy and also preventing accurate alignment and/or deployment of the valve prosthesis.

Due to the different physical characteristics of the mitral valve as compared to other valves, implantation of a valve in the mitral position has its own unique requirements for valve replacement. There is a continued desire to improve mitral valve replacement devices and procedures to accommodate the structure of the heart, including by providing improved devices and methods for replacing the mitral valve percutaneously. Embodiments hereof relate to methods and devices for managing chordae tendineae during a transapical valve replacement procedure.

<CIT> relates to a treatment device and treatment kit for a blood circulation conduit. <CIT> relates to a dual capture device for a stent graft delivery system. <CIT> relates to a mitral valve spacer. <CIT> relates to a percutaneously delivered temporary valve.

Disclosed herein are exemplary methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A valve delivery system is introduced into a ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof and a displacement component at the distal portion thereof, the displacement component being configured to be radially expandable between a first outer diameter and a second outer diameter. The valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has the first outer diameter. While the valve prosthesis is in the delivery configuration, the displacement component of the valve delivery system is radially expanded into an expanded state in which the displacement component has the second outer diameter greater than the first outer diameter. The valve delivery system is advanced towards the annulus of the native valve of the heart with the displacement component in the expanded state, wherein the second outer diameter is of a dimension that prevents the displacement component from passing through openings between chordae in the ventricle so that the displacement component in the expanded state pushes chordae in the ventricle radially outward away from the valve delivery system. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Specific embodiments of the present invention and further exemplary embodiments are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Unless otherwise indicated, the terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to the treating clinician. "Distal" and "distally" are positions distant from or in a direction away from the clinician, and "proximal" and "proximally" are positions near or in a direction toward the clinician. In addition, the term "self-expanding" is used in the following description and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or scaffold structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in embodiments hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and polycyclooctene can be used separately or in conjunction with other shape memory polymers.

Although the description of embodiments hereof are in the context of delivery systems for delivering a valve prosthesis within a native mitral valve, the valve delivery systems described herein can also be used in other valves of the body that include chordae tendineae, such as for delivering a valve prosthesis within a native tricuspid valve, or for delivering a mitral or tricuspid valve prosthesis within a failed previously-implanted prosthesis.

Embodiments hereof are related to a valve prosthesis configured for deployment within a native heart valve of the heart in a transcatheter heart valve implantation procedure. <FIG> is a perspective view of an exemplary transcatheter valve prosthesis <NUM> for use in embodiments hereof, wherein the valve prosthesis is in an expanded, deployed configuration in accordance with an embodiment hereof. Valve prosthesis <NUM> is illustrated herein in order to facilitate description of the chordae management methods and devices to be utilized in conjunction with a valve delivery system according to embodiments hereof. It is understood that any number of alternate heart valve prostheses can be used with the methods and devices described herein. Valve prosthesis <NUM> is merely exemplary and is similar to heart valve prostheses described in more detail in <CIT>, Other non-limiting examples of transcatheter valve prostheses useful with systems and methods of the present disclosure are described in <CIT>. , <CIT><CIT>, <CIT>, <CIT>, and <CIT>, each of which illustrate heart valve prostheses configured for placement in a mitral valve.

As shown in <FIG>, heart valve prosthesis <NUM> includes a flexible anchoring member <NUM> at least partially surrounding and coupled to an inner valve support <NUM>. Heart valve prosthesis <NUM> further includes a prosthetic valve component <NUM> coupled to, mounted within, or otherwise carried by valve support <NUM>. Heart valve prosthesis <NUM> also includes one or more sealing members <NUM> and tissue engaging elements <NUM>. For example, tissue engaging elements <NUM> may be spikes disposed on an upstream perimeter of anchoring member <NUM> and extend in an upward and/or radially outward direction to engage, and in some embodiments, penetrate the native tissue to facilitate retention or maintain position of the device in a desired implanted location. In another specific embodiment, sealing member <NUM> may extend around an inner wall of anchoring member <NUM> and/or around an exterior surface of valve support <NUM> to prevent paravalvular leaks between heart valve prosthesis <NUM> and the native tissue and/or between anchoring member <NUM> and valve support <NUM>. Tissue engaging elements <NUM> may also be included around an outer wall of anchoring member <NUM> and may extend outwardly to engage and, in some embodiments, penetrate the native valve leaflets or other adjacent tissue. Additionally, valve support <NUM> may have a plurality of coupling features <NUM>, such as eyelets, around an upstream end to facilitate loading, retention and deployment of heart valve prosthesis <NUM> within and from a delivery catheter (not shown), as further described herein.

Valve support <NUM> is a generally cylindrical stent or frame that supports a prosthetic valve component <NUM> within the interior thereof. Similarly, anchoring member <NUM> is also a stent or frame having a flared, funnel-like or hyperboloid shape. In some embodiments, valve support <NUM> and/or anchoring member <NUM> includes a plurality of posts <NUM> connected circumferentially by a plurality of struts <NUM>. Posts <NUM> and struts <NUM> may be arranged in a variety of geometrical patterns that may expand and provide sufficient resilience and column strength for maintaining the integrity of prosthetic valve component <NUM>. For example, posts <NUM> may extend longitudinally across multiple rows of struts <NUM> to provide column strength to the valve support <NUM>. Generally, the plurality of posts <NUM> may extend along an axial direction generally parallel to the longitudinal axis and the struts <NUM> may extend circumferentially around and transverse to the longitudinal axis. As will be understood by one of ordinary skill in the art, the stent or frame of a valve prosthesis may have other configurations such as a metallic, polymeric, or fabric mesh or a woven construction. In embodiments hereof, valve support <NUM> is self-expanding to return to an expanded deployed state from a compressed or constricted delivery state and may be made from stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or Nitinol, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. "Self-expanding" as used herein means that a structure/component has a mechanical memory to return to the expanded or deployed configuration as described herein. Alternatively, valve prosthesis <NUM> may be balloon-expandable as would be understood by one of ordinary skill in the art. Whether valve support <NUM> is self-expanding or balloon-expandable, valve prosthesis <NUM> has a compressed configuration for delivery within a valve delivery system and a radially expanded configuration for deployment within an annulus of the native valve site. In some embodiments, anchoring member <NUM> and/or valve support <NUM> may be laser cut from a single metal tube into the desired geometry, creating a tubular scaffold of interconnected struts. Anchoring member <NUM> may then be shaped into a desired configuration, e.g. a flared, funnel-like or hyperboloid shape, using known shape-setting techniques for such materials.

As previously mentioned, valve prosthesis <NUM> includes prosthetic valve component <NUM> within the interior of valve support <NUM>. Prosthetic valve component <NUM> is configured as a one-way valve to allow blood flow in one direction and thereby regulate blood flow there-through. Prosthetic valve component <NUM> is capable of blocking flow in one direction to regulate flow there-through via valve leaflets that may form a bicuspid or tricuspid replacement valve. More particularly, if valve prosthesis <NUM> is configured for placement within a native valve having two leaflets such as the mitral valve, prosthetic valve component <NUM> includes two valve leaflets to form a bicuspid replacement valve that closes with pressure on the outflow and opens with pressure on the inflow. In other embodiments in accordance herewith, the prosthetic valve component may be a tricuspid replacement valve or may be a single leaflet replacement valve. The valve leaflets are sutured or otherwise securely and sealingly attached to an inner circumference of valve support <NUM> and/or sealing members <NUM> which encloses or lines valve support <NUM> as would be known to one of ordinary skill in the art of prosthetic tissue valve construction.

The valve leaflets may be made of pericardial material; however, the leaflets may instead be made of another material. Natural tissue for prosthetic valve leaflets for use in prosthetic valve component <NUM> may be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals, such as tissue from bovine, equine or porcine origins. Synthetic materials suitable for use as prosthetic valve leaflets in embodiments hereof include DACRON® polyester commercially available from Invista North America S. of Wilmington, DE, polyurethane, Gore-Tex or other cloth materials, nylon blends, polymeric materials, and vacuum deposition nitinol fabricated materials. One polymeric material from which the replacement valve leaflets may be made is an ultra-high molecular weight polyethylene material commercially available under the trade designation DYNEEMA from Royal DSM of the Netherlands. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

Sealing members <NUM> are formed from a suitable graft material such as a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, sealing members <NUM> may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent. In one embodiment, sealing members <NUM> may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other appropriate cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz. , for example.

<FIG> illustrates a sectional view of a heart H, illustrating a left atrium LA, a left ventricle LV, a mitral valve MV and an aortic valve AV. Blood flow BF is depicted with directional arrows in <FIG> in the left atrium LA, into left ventricle LV through mitral valve MV, and into the aorta through aortic valve AV. Mitral valve MV is saddle-shaped and includes two native leaflets, posterior leaflet PL and anterior leaflet AL, and chordae tendineae CT extend within the left ventricle LV between the native leaflets of the mitral valve MV and the papillary muscles. As previously described herein, chordae tendineae CT are cord-like tendons that connect the medial papillary muscle MPM to the posterior leaflet PL of the mitral valve MV and connect the lateral papillary muscle LPM to the anterior leaflet AL of the mitral valve MV. When the native mitral valve is operating properly, the native leaflets will generally function in such a way that blood flows toward the left ventricle LV when the leaflets are in an open position, and so that blood is prevented from moving toward the left atrium LA when the leaflets are in a closed position. During systole, when the native leaflets close to prevent backflow of blood into the atrium, the chordae tendineae CT assist in preventing the native leaflets from everting or prolapsing into the atrium by becoming tense and holding the native leaflets in the closed position.

<FIG> is an illustration of valve prosthesis <NUM> implanted within a native mitral heart valve, which is shown in section. Valve prosthesis <NUM> is shown deployed within a native mitral valve, with an upstream end thereof extending into the left ventricle and a downstream end thereof extending into the left atrium. When valve prosthesis <NUM> is deployed within the valve annulus of a native heart valve, valve support <NUM> and anchoring member <NUM> expands within native valve leaflets, posterior leaflet PL and anterior leaflet AL, of the patient's defective valve, retaining the native valve leaflets in a permanently open state.

One method of delivering valve prosthesis <NUM> includes delivery via a transapical approach directly through the apex of the heart via a thoracotomy, as best illustrated in <FIG> is a sectional view illustration of the anatomy of heart illustrating an exemplary transapical delivery pathway or route represented by directional arrow <NUM> for delivery of valve prosthesis <NUM> to the native mitral valve, located between the left atrium and left ventricle. <FIG> also illustrates an exemplary transapical delivery pathway or route represented by directional arrow <NUM> for delivery of a valve prosthesis to the native tricuspid valve, located between the right atrium and right ventricle. In a transapical approach, access to the heart is gained via thoracic incision, which can be a conventional open thoracotomy or sternotomy, or a smaller intercostal or sub-xyphoid incision or puncture. An access cannula is then placed through a puncture, sealed by a purse-string suture, in the wall of the left ventricle at or near the apex of the heart. Valve delivery systems described herein may then be introduced into the left ventricle through this access cannula. The transapical approach has the feature of providing a shorter, straighter, and more direct path to the mitral or tricuspid valve. Further, because it does not involve intravascular access, the transapical procedure can be performed by surgeons who may not have the necessary training in interventional cardiology to perform the catheterizations required in other percutaneous approaches. During delivery, if self-expanding, the valve prosthesis remains compressed until it reaches a target diseased native heart valve, at which time the valve prosthesis can be released from the valve delivery system and expanded in situ via self-expansion. The valve delivery system is then removed and valve prosthesis <NUM> remains deployed within the native target heart valve. Alternatively, valve prosthesis <NUM> may be balloon-expandable and delivery thereof may be accomplished via a balloon catheter as would be understood by one of ordinary skill in the art.

However, as previously described herein, the chordae tendineae may act as an obstacle within delivery pathways <NUM>, <NUM> when valve prosthesis <NUM> is delivered transapically and the valve delivery system may become entangled in chordae tendineae during advancement. Embodiments hereof relate to methods and devices for managing chordae tendineae during a transapical valve replacement procedure. More particularly, embodiments hereof relate to a valve delivery system <NUM> having a displacement component <NUM> integrated into or onto the valve delivery system to displace chordae tendineae and thereby clear a pathway for the valve delivery system. Displacement component <NUM> is configured to be radially expandable between a first outer diameter and a second outer diameter in order to relocate or displace the chordae tendineae which interfere with mitral or tricuspid access from the apex. The first outer diameter is not greater than an outer diameter of the outer shaft and the second outer diameter is greater than the outer diameter of the outer shaft. The second outer diameter is of a dimension that prevents displacement component <NUM> from passing through openings between chordae in a left ventricle so that displacement component <NUM> in the expanded state displaces or pushes chordae in a ventricle radially outward away from the valve delivery system.

<FIG> is a side view of valve delivery system <NUM> according to an embodiment thereof which may be used to deliver and deploy heart valve prosthesis <NUM> disclosed herein to the heart of a patient. Valve delivery system <NUM> includes a guiding catheter GC and a valve delivery catheter <NUM>. Guiding catheter GC has a handle <NUM> coupled to a delivery shaft <NUM>, which in one embodiment is <NUM> F or less, and in another embodiment, <NUM> F or less in diameter. Guiding catheter GC may be steerable or preshaped in a configuration suitable for the particular approach to the target valve. Valve delivery catheter <NUM> is placed through a hemostasis valve HV on a proximal end of guiding catheter GC.

Valve delivery catheter <NUM> is depicted in a delivery configuration in <FIG> and <FIG> with heart valve prosthesis <NUM> loaded within a distal delivery sheath or capsule <NUM> of the delivery system. As shown in <FIG>, valve delivery catheter <NUM> includes a tubular outer shaft <NUM> defining a lumen <NUM> there-through and a tubular inner shaft <NUM> defining a lumen <NUM> there-through. A nosecone or distal tip <NUM> is coupled to a distal end of inner shaft <NUM>. Inner shaft <NUM> is concentrically slideably disposed within lumen <NUM> of outer shaft <NUM>, and lumen <NUM> of inner shaft <NUM> may be sized to slidingly receive a guidewire <NUM> such that valve delivery catheter <NUM> may be tracked over the guidewire during delivery of heart valve prosthesis <NUM>. Inner shaft <NUM> extends through heart valve prosthesis <NUM> to distal tip <NUM>. Outer shaft <NUM> extends to delivery sheath or capsule <NUM> and in the delivery configuration of <FIG>, delivery sheath or capsule <NUM> is disposed over heart valve prosthesis <NUM> to compressively retain heart valve prosthesis <NUM> in the collapsed or delivery configuration and in crimped engagement with inner shaft <NUM>.

Heart valve prosthesis <NUM> is coupled to the inner shaft <NUM> and is releasable from the inner shaft <NUM> by release wires <NUM>, as more fully described below. Delivery sheath or capsule <NUM> can protect and secure heart valve prosthesis <NUM> in its collapsed configuration during delivery. Outer shaft <NUM> is coupled to a retraction mechanism <NUM> on a handle <NUM> of valve delivery catheter <NUM>. Various retraction mechanisms <NUM> may be used, such as an axially-slidable lever, a rotatable rack and pinion gear, or other known mechanisms. In this way, outer shaft <NUM> may be retracted relative to inner shaft <NUM> to release (e.g., deploy) heart valve prosthesis <NUM> from delivery sheath or capsule <NUM>.

<FIG> is an enlarged sectional view showing the distal end of valve delivery catheter <NUM> with delivery sheath or capsule <NUM> cut away to illustrate the coupling of heart valve prosthesis <NUM> to inner shaft <NUM>, which is also described in more detail in <CIT>. A plurality of locking fingers <NUM> are coupled to nosecone <NUM> and extend proximally through the interior of valve support <NUM> of heart valve prosthesis <NUM>. A selected number of posts <NUM> of valve support <NUM> of heart valve prosthesis <NUM> have a coupling element <NUM> comprising a tab <NUM> cut out from each post <NUM> at a proximal end thereof. Tab <NUM> may be deflected inwardly from the post <NUM> as shown in <FIG> and is configured to extend through a window or opening in locking finger <NUM>. Release or control wires <NUM> pass through tabs <NUM>, which secure heart valve prosthesis <NUM> to the inner shaft <NUM>. Release or control wires <NUM> can be sandwiched tightly between tabs <NUM> and locking fingers <NUM>, such that friction temporarily prevents release or control wire <NUM> from slipping in a proximal or distal direction. In this way, delivery sheath or capsule <NUM> may be retracted relative to heart valve prosthesis <NUM> to permit expansion of heart valve prosthesis <NUM> while the inner shaft <NUM> maintains the longitudinal position of heart valve prosthesis <NUM> relative to the anatomy. Release or control wires <NUM> may extend proximally to handle <NUM>, for example, in between inner shaft <NUM> and outer shaft <NUM> or within one or more designated lumens. A suitable mechanism (not shown) on handle <NUM> can allow the operator to retract release or control wires <NUM> in a proximal direction until they are disengaged from tabs <NUM>. Accordingly, heart valve prosthesis <NUM> can be released from locking fingers <NUM> and expand for deployment at the target site.

In the embodiment of <FIG>, displacement component <NUM> is a balloon coupled to and surrounding an exterior surface of delivery sheath or capsule <NUM>. <FIG> and <FIG> depict displacement component <NUM> in its unexpanded or uninflated state, while <FIG> illustrates displacement component <NUM> in its expanded or inflated state. Displacement component <NUM> is radially expandable between a first outer diameter D<NUM> in its unexpanded or uninflated state and a second outer diameter D<NUM> in its expanded or inflated state. In the unexpanded or uninflated state with first outer diameter D<NUM>, the width of displacement component <NUM> is marginal so as not to increase the overall size and profile of valve delivery catheter <NUM>. As shown in <FIG>, in its expanded or inflated state with second outer diameter D<NUM>, displacement component <NUM> may have a tapered profile or configuration in which an outer diameter thereof decreases from a distal end <NUM> to a proximal end <NUM> thereof. When the outer diameter varies in the expanded or inflated stated, as used herein "second outer diameter" refers to the greatest or largest dimension of the expanded or inflated displacement component unless otherwise stated. In another embodiment depicted in <FIG>, in its expanded or inflated state, displacement component <NUM> does not have a tapered profile or configuration. An inflation lumen <NUM> extends along the length of valve delivery catheter <NUM> to transmit inflation fluid into displacement component <NUM> for expansion. In an embodiment hereof, inflation lumen <NUM> is a single point inflation lumen defined a tubular component that extends along the exterior of inner shaft <NUM> and/or the interior of outer shaft <NUM> into proximal end <NUM> of displacement component <NUM>. In another embodiment hereof (not shown), the inflation lumen may be formed in a sidewall of the outer shaft. Inflation fluid is received through a luer hub <NUM> (shown on <FIG>) of handle <NUM> or other type of fitting that may be connected to a source of inflation fluid to be delivered to displacement component <NUM>.

Proximal and distal ends <NUM>, <NUM>, respectively, of displacement component <NUM> are sealingly attached to the exterior surface of capsule <NUM>. Adjacent to proximal end <NUM>, displacement component <NUM> is connected to inflation lumen <NUM> through an inflation port or opening <NUM> which is formed through a sidewall of capsule <NUM>. Opening <NUM> is located proximal to heart valve prosthesis <NUM> on inner shaft <NUM> so that integration of inflation lumen <NUM> and displacement component <NUM> does not increase the overall profile and size of the delivery catheter.

Displacement component <NUM> may be made of a polymeric material such as may commonly be used for dilatation balloons, including without limitation PEBAX, Grilimid, nylon in various grades, latex, polyethylene terephthalate (PET), polyamide <NUM> or polyethylene block amide copolymer. Outer and inner shafts <NUM>, <NUM> of valve delivery catheter <NUM> are formed of any suitable flexible polymeric material. Non-exhaustive examples of material for the shaft components are polyethylene terephalate (PET), nylon, polyethylene, PEBAX, or combinations of any of these, either blended or co-extruded. Optionally, a portion of the shaft components is formed as a composite having a reinforcement material incorporated within a polymeric body to enhance strength, flexibility, and/or toughness. Suitable reinforcement layers include braiding, wire mesh layers, embedded axial wires, embedded helical or circumferential wires, and the like. In an embodiment, the proximal portion of outer shaft <NUM> may in some instances be formed from a metallic tubing, such as a hypotube, or a reinforced polymeric tube as shown and described, for example, in <CIT>. The shaft components may have any suitable working length to extend to a target location within the heart.

<FIG> are cross-sectional views of a heart showing a method of delivering a heart valve prosthesis <NUM> to an annulus of a native mitral valve of a heart using a transapical approach in accordance with embodiments hereof. Referring to <FIG>, valve delivery catheter <NUM> is advanced over a guidewire GW through guiding catheter GC (not shown) which enters the left ventricle LV of the heart through a puncture in the left ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Alternatively, valve delivery catheter <NUM> may be placed directly through a purse-string-sealed transapical incision without a guiding catheter. Valve delivery catheter <NUM> is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adjacent to the apex of the heart. Stated another way, "transapical approach" as used herein is not limited to introduction via only the apex of the heart but also includes the ventricular wall adjacent to the apex of the heart since the anatomy of a heart may vary from patient to patient. Further, as noted above, although described in <FIG> as being introduced into the left ventricle for treatment of chordae tendineae associated with a native mitral valve, valve delivery catheter <NUM> may be similarly introduced into the right ventricle for treatment of chordae tendineae associated with a native tricuspid valve. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within capsule <NUM>, and displacement component <NUM> is in its delivery or unexpanded state in which the displacement component has the first outer diameter D<NUM>.

With heart valve prosthesis still in the delivery configuration, displacement component <NUM> of valve delivery catheter <NUM> is radially expanded into its expanded or inflated state in which the displacement component has the second outer diameter D<NUM> greater than the first outer diameter D<NUM>. Valve delivery catheter <NUM> is then maneuvered and advanced towards the annulus of the native mitral valve of the heart with displacement component <NUM> in the expanded or inflated state until displacement component <NUM> (and delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM>) is positioned within the annulus of the native mitral valve between native leaflets AL, PL as shown in <FIG>. With displacement component <NUM> inflated, displacement component <NUM> displaces or pushes all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. The second outer diameter D<NUM> of inflated displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle. Displacement of the chordae tendineae CT does not damage the chordae tendineae, but rather provides an unobstructed pathway to the native mitral valve. In an embodiment hereof, displacement component <NUM> may be inflated with an endoinflater (not shown) as will be understood by one of ordinary skill in the art. Displacement component <NUM> may be fully inflated or expanded, or may be only partially inflated or expanded as required to push all chordae tendineae, trabeculae and ventricular bands radially outwards towards the ventricular wall. The width and length of displacement component <NUM> relative to the size of the left ventricle may vary from that depicted in <FIG>. The dimensions vary according to application and are only required to be configured to push chordae tendineae outwards enough provide to an unobstructed pathway to the native mitral valve, or to be configured to provide feedback to the user that displacement component <NUM> has become entangled during advancement.

Once displacement component <NUM> (and delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM>) is positioned within the annulus of the native mitral valve between native leaflets AL, PL, displacement component <NUM> is at least partially radially collapsed prior to deployment of heart valve prosthesis <NUM> as shown in <FIG>. Heart valve prosthesis <NUM> is then deployed or expanded into apposition with the annulus of the native mitral valve. More particularly, referring to <FIG>, capsule <NUM> is proximally retracted to expose and release the entire length of heart valve prosthesis <NUM>. Valve prosthesis <NUM> selfexpands into apposition with the surrounding native anatomy, i.e., with the annulus of the native valve. Release or control wires <NUM> may be retracted in a proximal direction to release heart valve prosthesis <NUM> from valve delivery catheter <NUM>, allowing the valve delivery system to be removed and the device to be fully implanted at the native mitral valve in the deployed configuration as shown in <FIG>. In an embodiment, heart valve prosthesis <NUM> may be expanded upstream of the desired target location then pulled downstream into the target location before releasing heart valve prosthesis <NUM> from valve delivery catheter <NUM>. Alternatively, heart valve prosthesis <NUM> may not be connected to the valve delivery catheter such that heart valve prosthesis <NUM> deploys and is fully released from valve delivery catheter <NUM>.

In another embodiment hereof, the valve prosthesis is fully deployed prior to deflating displacement component <NUM>. Stated another way, the step of deploying heart valve prosthesis <NUM> into apposition with the annulus of the native mitral valve occurs with displacement component <NUM> in the expanded state. More particularly, capsule <NUM> may be proximally retracted to expose and release the entire length of heart valve prosthesis <NUM> with displacement component <NUM> in its inflated state. With displacement component <NUM> in its inflated state, chordae tendineae CT will be pushed away from the heart valve prosthesis during deployment thereof. Displacement component <NUM> is then deflated after deployment of the heart valve prosthesis so that valve delivery catheter <NUM> may be retracted and removed from the patient.

<FIG> illustrate another embodiment of a displacement component <NUM> that may be used in a valve delivery catheter <NUM>. Valve delivery catheter is similar to valve delivery catheter <NUM> described above. However, in this embodiment, displacement component <NUM> includes a first balloon 1430A that is coupled to an inner shaft <NUM> of the valve delivery catheter and a second balloon 1430B which is similar to displacement component <NUM> and integrated onto an outer surface of capsule <NUM>. In the unexpanded or uninflated state with a first outer diameter D<NUM> (not shown in <FIG> but shown in <FIG>), the width of first and second balloons 1430A, 1430B, respectively, are marginal so as not to increase the overall size and profile of valve delivery catheter <NUM>. First balloon 1430A forms the distalmost tip of valve delivery catheter <NUM> and thus replaces nosecone or distal tip <NUM> of valve delivery catheter <NUM>. First balloon 1430A has a generally conical shape when in an inflated state as shown in <FIG>, with a brim or base <NUM> that has a wider outer diameter than a conical portion <NUM> that narrows or decreases from a proximal end <NUM> to a distal end <NUM> thereof. Brim or base <NUM> has a second outer diameter D<NUM> which is greater than first outer diameter D<NUM>. An inflation lumen 1454A extends along the length of valve delivery catheter <NUM> to transmit inflation fluid into first balloon 1430A for expansion. As best shown in <FIG>, which is a cross-section of inner shaft <NUM> removed from the valve delivery catheter for illustrative purposes only, inflation lumen 1454A is formed in a sidewall of the inner shaft. Inflation lumen 1454A may be crescent shaped as shown, although other shapes are suitable as well. Inner shaft <NUM> defines guidewire lumen <NUM> so that valve delivery catheter <NUM> may be tracked over a guidewire. First balloon 1430A is connected to inflation lumen 1454A through an inflation port or opening 1456A formed through a sidewall of inner shaft <NUM>. Inflation fluid is received through a second luer hub (not shown) of handle <NUM> or other type of fitting that may be connected to a source of inflation fluid to be delivered to first balloon 1430A.

For second balloon 1454B, an inflation lumen 1454B extends along the length of valve delivery catheter <NUM> to transmit inflation fluid into second balloon 1430B for expansion. In an embodiment hereof, inflation lumen 1454B is a single point inflation lumen defined a tubular component that extends along the exterior of inner shaft <NUM> and/or the interior of outer shaft <NUM> into the proximal end of second balloon 1430B. Adjacent to the proximal end thereof, second balloon 1430B is connected to inflation lumen 1454B through an inflation port or opening 1456B formed through a sidewall of capsule <NUM>. Inflation fluid is received through luer hub <NUM> (not shown in <FIG>) of handle <NUM> or other type of fitting that may be connected to a source of inflation fluid to be delivered to second balloon 1430B.

Displacement component <NUM> may be used to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. As described with respect to <FIG> herein, valve delivery catheter <NUM> is introduced into a ventricle of the heart through a puncture in the ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Valve delivery catheter <NUM> is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adj acent to the apex of the heart as described above. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within delivery the sheath or capsule <NUM>, and displacement component <NUM> is in its delivery or unexpanded state in which the displacement component has a first or unexpanded outer diameter D<NUM>. With heart valve prosthesis still in the delivery configuration, both first and second balloons 1430A, 1430B, respectively, of displacement component <NUM> are radially expanded into their expanded or inflated states in which displacement component <NUM> has the second outer diameter D<NUM> greater than the first outer diameter D<NUM>. Valve delivery catheter <NUM> is then maneuvered and advanced towards the annulus of the native valve of the heart with displacement component <NUM> in the expanded state. With displacement component <NUM> inflated, displacement component <NUM> displaces or pushes all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. The second outer diameter D<NUM> of inflated displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle. First balloon 1430A of displacement component <NUM> creates a path through the chordae tendineae CT for valve delivery catheter <NUM> to follow, while second balloon 1430B located around capsule <NUM> avoids entanglement or hang up of the chordae tendineae CT thereon. Once delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM> is positioned within the annulus of the native mitral valve, displacement component <NUM> may be deflated and heart valve prosthesis <NUM> is then deployed or expanded into apposition with the annulus of the native mitral valve. Alternatively, heart valve prosthesis <NUM> may be deployed with displacement component <NUM> still inflated and first and/or second balloons 1430A, 1430B may be deflated after deployment of the heart valve prosthesis. Further, although depicted with both first and second balloons 1430A, 1430B, displacement component <NUM> in another embodiment hereof may include only first balloon 1430A for displacing chordae tendineae CT during advancement of the valve delivery system.

<FIG> illustrate another embodiment of a displacement component <NUM> that may be used in a valve delivery catheter <NUM>. Valve delivery catheter <NUM> is similar to valve delivery catheter <NUM> described above except that a balloon protection device <NUM> is disposed thereover. More particularly, balloon protection device <NUM> includes an outermost sheath <NUM> that defines a lumen <NUM> there-through and also includes displacement component <NUM> at a distal end of outermost sheath <NUM>. Outer shaft <NUM> and capsule <NUM> are disposed within lumen <NUM> of outermost sheath <NUM>. Outermost sheath <NUM> is coupled to capsule <NUM> such that outermost sheath <NUM> moves concurrently with valve delivery catheter <NUM> as an assembly. Balloon protection device <NUM> may be considered an integrated sub-assembly of valve delivery catheter <NUM>. As will be explained in more detail herein, balloon protection device <NUM> is temporarily and releasably attached to valve delivery catheter <NUM> via a coupling mechanism <NUM> (shown in <FIG>) so that balloon protection device <NUM> may be selectively detached from valve delivery catheter <NUM>.

In the embodiment of <FIG>, displacement component <NUM> is a balloon coupled to and surrounding an exterior surface of outermost sheath <NUM> of balloon protection device <NUM>. In the unexpanded or uninflated state with a first outer diameter D<NUM> (not shown in <FIG> but shown in <FIG>), the width of displacement component <NUM> is marginal so as not to increase the overall size and profile of valve delivery catheter <NUM>. Displacement component <NUM> is disposed distal to valve prosthesis <NUM> and also is primarily disposed distal to nosecone <NUM> of valve delivery catheter <NUM> so that displacement component <NUM> forms a distalmost tip of valve delivery catheter <NUM>. An inflation lumen <NUM> extends along the length of balloon protection device <NUM> to transmit inflation fluid into displacement component <NUM> for expansion. As best shown in <FIG>, which is a cross-section of outermost sheath <NUM> removed from the valve delivery catheter for illustrative purposes only, inflation lumen <NUM> is formed in a sidewall of outermost sheath <NUM>. Inflation lumen <NUM> may be crescent shaped as shown, although other shapes are suitable as well. Displacement component <NUM> is connected to inflation lumen <NUM> through an inflation port or opening <NUM> which is formed through a sidewall of outermost sheath <NUM>. Inflation fluid is received through a luer hub (not shown) of a handle disposed outside of the patient or other type of fitting that may be connected to a source of inflation fluid to be delivered to displacement component <NUM>.

Displacement component <NUM> may be used to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. As described with respect to <FIG> herein, valve delivery catheter <NUM>, concurrently with balloon protection device <NUM>, is introduced into a ventricle of the heart through a puncture in the ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Outermost sheath <NUM> of balloon protection device <NUM> is initially attached to outer shaft <NUM> of valve delivery system <NUM>, and the entire system is advanced together as one. More particularly, with additional reference to <FIG>, coupling mechanism <NUM> releasably couples outermost sheath <NUM> of balloon protection device <NUM> to outer shaft <NUM> of valve delivery system <NUM>. Coupling mechanism <NUM> includes an annular hub <NUM>, an O-ring <NUM> disposed on an inner surface of hub <NUM>, two opposing pins 3794A, 3794B, and two opposing user contact buttons 3796A, 3796B. Outer shaft <NUM> of valve delivery system <NUM> includes a first set of two recesses or holes (not shown) formed on the outer surface thereof, just distal to handle <NUM>. Hub <NUM> is disposed at a proximal end (not shown) of outermost shaft <NUM> of balloon protection device <NUM>. Hub <NUM> is disposed over the first set of two holes of outer shaft <NUM> so that the coupling mechanism is positioned or disposed over a proximal end of outer shaft <NUM>, just distal to handle <NUM>. Pins 3794A, 3794B slidingly extend through the sidewall of hub <NUM>. Pins 3794A, 3794B may be manually pushed inwards and pulled outwards in a radial direction via user contact buttons 3796A, 3796B, respectively. When pins 3794A, 3794B are manually pushed radially inwards, they extend or sit within the corresponding first set of holes on outer shaft <NUM> of valve delivery system <NUM> thus temporarily locking or attaching the balloon protection device to the valve delivery system. When pins 3794A, 3794B in the hub of balloon protection device <NUM> are manually pulled radially outwards, the balloon protection device is not attached to the valve delivery system and coupling mechanism <NUM> may longitudinally slide along the outer surface of outer shaft <NUM> via O-ring <NUM> so that the balloon protection device may be repositioned as described herein. <FIG> illustrates pins 3794A, 3794B in an engaged or coupled configuration in which the pins are pushed radially inwards and configured to be disposed within the first set of two holes of outer shaft <NUM>, while <FIG> illustrates pins 3794A, 3794B in a disengaged or uncoupled configuration in which the pins are flush with the inner surface of coupling mechanism <NUM> and coupling mechanism <NUM> is thus no longer attached to outer shaft <NUM> of valve delivery system <NUM>.

With pins 3794A, 3794B in an engaged or coupled configuration to temporarily attach the balloon protection device to the valve delivery system, balloon protection device <NUM> and valve delivery system <NUM> are simultaneously advanced together as one. Valve delivery catheter <NUM>, concurrently with balloon protection device <NUM>, is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adjacent to the apex of the heart as described above. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within delivery the sheath or capsule <NUM>, and displacement component <NUM> of balloon protection device <NUM> is in its delivery or unexpanded state in which the displacement component has a first or unexpanded outer diameter D<NUM>.

After valve delivery system <NUM> and balloon protection device <NUM> are positioned within the left ventricle as desired, balloon protection device <NUM> is disconnected or detached from valve delivery system <NUM>. In order to disconnect or detach balloon protection device <NUM> from valve delivery system <NUM>, pins 3794A, 3794B are moved to the disengaged or uncoupled configuration in which the pins are flush with the inner surface of coupling mechanism <NUM> and coupling mechanism <NUM> is no longer attached to outer shaft <NUM> of valve delivery system <NUM>. Pins 3794A, 3794B are moved to the disengaged or uncoupled configuration via user contact buttons 3796A, 3796B, respectively, which breaks the connection between the balloon protection device and the valve delivery system sheath.

After disconnection, balloon protection device <NUM> and valve delivery system <NUM> are longitudinally movable or slidable relative to one another via O-ring <NUM> of coupling mechanism <NUM>. Balloon protection device <NUM> is then distally advanced further into the heart by the physician, independent of valve delivery system <NUM>. With heart valve prosthesis <NUM> still in the delivery configuration within valve delivery system <NUM>, displacement component <NUM> of balloon protection device <NUM> is radially expanded into its expanded or inflated state in which the displacement component has the second outer diameter D<NUM> greater than the first outer diameter D<NUM>, moving the chordae tendinae aside and creating a pathway through which valve delivery system <NUM> may pass through. The second outer diameter D<NUM> of inflated displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle. At this point, balloon protection device <NUM> is not advanced any further and is held in place by the physician holding the proximal portion thereof outside the body. Valve delivery system <NUM> is then distally advanced through lumen <NUM> of balloon protection device <NUM>, while the balloon protection device remains in place pushing the chordae aside. Once delivery sheath or capsule <NUM> is positioned within the annulus of the native mitral valve for deployment of heart valve prosthesis <NUM>, balloon protection device <NUM> is reconnected to outer shaft <NUM> of valve delivery system <NUM>. More particularly, outer shaft <NUM> includes a second set of two recesses or holes (not shown) formed on the outer surface thereof, distal to the first set of holes, which permit balloon protection device <NUM> to be reconnected to outer shaft <NUM> of valve delivery system <NUM>. Pins 3794A, 3794B are moved back into the engaged or coupled configuration to re-attach the balloon protection device to the valve delivery system. Balloon protection device <NUM> and valve delivery system <NUM> can then be concurrently proximally retracted as an assembly to deploy or expand heart valve prosthesis <NUM> into apposition with the annulus of the native mitral valve. After deployment of heart valve prosthesis <NUM>, balloon protection device <NUM> and valve delivery system <NUM> are still connected and thus are concurrently proximally retracted to be removed from the body.

In an embodiment, inflation of displacement component <NUM> may occur in a pulsative manner. More particularly, the step of radially expanding displacement component <NUM> includes repeatedly or systematically inflating displacement component <NUM> in a pulsative manner in which displacement component <NUM> is inflated for a first time period and displacement component <NUM> is slightly or partially deflated for a second time period. Valve delivery system <NUM> is maneuvered and advanced towards the annulus of the native mitral valve of the heart during the second time period when displacement component <NUM> is at least slightly or partially deflated. As such, full inflation of displacement component <NUM> occurs when valve delivery system <NUM> is stationary and the chordae tendineae are displaced or pushed out of the way prior to movement of the valve delivery system, thereby allowing valve delivery system <NUM> to safely pass through the ventricle without interference from the chordae tendineae.

<FIG> illustrate another embodiment of a displacement component <NUM> that may be used in a valve delivery catheter <NUM>. Valve delivery catheter <NUM> is similar to valve delivery catheter <NUM> described above except that displacement component <NUM> in its unexpanded or uninflated state is housed within a nosecone or distal tip <NUM>. More particularly, nosecone <NUM> is a hollow casing or shell defining a space or chamber <NUM>. Displacement component <NUM> is a balloon coupled to a tubular component that defines an inflation lumen <NUM> there-through. Inflation lumen <NUM> extends along the length of valve delivery catheter <NUM> to transmit inflation fluid into displacement component <NUM> for expansion. Inflation lumen <NUM> is a single point inflation lumen defined the tubular component that extends along the exterior of inner shaft <NUM>. Displacement component <NUM> is disposed at the distal end of the tubular component that defines inflation lumen <NUM>. Inflation fluid is received through luer hub <NUM> (not shown in <FIG>) of handle <NUM> or other type of fitting that may be connected to a source of inflation fluid to be delivered to displacement component <NUM>.

In the unexpanded or uninflated state shown in <FIG>, displacement component <NUM> has a first outer diameter D<NUM> is housed or disposed within chamber <NUM> defined by nosecone <NUM> to thereby provide the displacement component with its delivery state. Displacement component <NUM> in the unexpanded or uninflated state has a second outer diameter D<NUM> and extends around inner shaft <NUM> which extends through the center of nosecone <NUM>. In the expanded or inflated state shown in <FIG>, displacement component <NUM> extends through an opening or port <NUM> formed through nosecone <NUM> to deploy outside of chamber <NUM> and nosecone <NUM> to thereby provide the displacement component with its expanded state.

Displacement component <NUM> may be used to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. As described with respect to <FIG> herein, valve delivery catheter <NUM> is introduced into a ventricle of the heart through a puncture in the ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Valve delivery catheter <NUM> is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adj acent to the apex of the heart as described above. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within delivery the sheath or capsule <NUM>, and displacement component <NUM> is in its delivery or unexpanded state in which the displacement component has a first or unexpanded outer diameter D<NUM> and is housed or disposed within chamber <NUM> of nosecone <NUM>. With heart valve prosthesis <NUM> still in the delivery configuration, displacement component <NUM> is radially expanded through port <NUM> formed through nosecone <NUM> into its expanded or inflated state in which the displacement component has the second outer diameter D<NUM> greater than the first outer diameter D<NUM> and is disposed outside of chamber <NUM> and nosecone <NUM>. Valve delivery catheter <NUM> is then maneuvered and advanced towards the annulus of the native valve of the heart with displacement component <NUM> in the expanded state. With displacement component <NUM> inflated and disposed outside of nosecone <NUM>, displacement component <NUM> displaces or pushes all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. The second outer diameter D<NUM> of inflated displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle. Once delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM> is positioned within the annulus of the native mitral valve, displacement component <NUM> may be deflated and heart valve prosthesis <NUM> is then deployed or expanded into apposition with the annulus of the native mitral valve. When deflated, displacement component <NUM> may retract or return back into chamber <NUM> of nosecone <NUM> due to a suction force created by removal of the inflation fluid from the interior of displacement component <NUM>. In another embodiment, displacement component <NUM> may remain external or outside of nosecone <NUM> after deflation. Alternatively, heart valve prosthesis <NUM> may be deployed with displacement component <NUM> still inflated.

<FIG> illustrate another embodiment of a displacement component <NUM> that is similar to displacement component <NUM>. In this embodiment, displacement component <NUM> in its unexpanded or uninflated state is housed within a nosecone or distal tip <NUM> but is coupled to and surrounds an exterior surface of a distal end of an inner shaft <NUM>, which is slidingly disposed within outer shaft <NUM> and capsule <NUM>. As best shown in <FIG>, which is a cross-section of inner shaft <NUM> removed from a valve delivery catheter <NUM> for illustrative purposes only, inflation lumen <NUM> is formed in a sidewall of the inner shaft. Inflation lumen <NUM> may be crescent shaped as shown, although other shapes are suitable as well. Inner shaft <NUM> defines guidewire lumen <NUM> so that valve delivery catheter <NUM> may be tracked over a guidewire. Displacement component <NUM> is connected to inflation lumen <NUM> through an inflation port or opening <NUM> which is formed through a sidewall of inner shaft <NUM>. Inflation fluid is received through luer hub <NUM> (not shown in <FIG>) of handle <NUM> or other type of fitting that may be connected to a source of inflation fluid to be delivered to displacement component <NUM>.

Similar to nosecone <NUM>, nosecone <NUM> is a hollow casing or shell defining a space or chamber <NUM>. In the unexpanded or uninflated state shown in <FIG>, displacement component <NUM> has a first outer diameter D<NUM> is housed or disposed within chamber <NUM> defined by nosecone <NUM> to thereby provide the displacement component with its delivery state. When it is desired to expand or inflate displacement component <NUM>, inner shaft <NUM> is slidingly distally advanced as indicated by directional arrow <NUM> through an opening or port <NUM> formed in nosecone <NUM> until displacement component <NUM> is disposed outside of or external to nosecone <NUM>. Once displacement component <NUM> is external to nosecone <NUM>, displacement component <NUM> may be inflated to an expanded or inflated state similar to that shown in <FIG>. Similarly, when it is desired to deflate displacement component <NUM>, displacement component <NUM> is deflated and then inner shaft <NUM> is slidingly proximally retracted through opening or port <NUM> formed in nosecone <NUM> until the deflated displacement component <NUM> is disposed within nosecone <NUM>.

<FIG> illustrate another embodiment of a displacement component <NUM> that may be used in a valve delivery catheter <NUM>. Valve delivery catheter <NUM> is similar to valve delivery catheter <NUM> described above except that displacement component <NUM> is a radially expandable distal tip that is coupled to a distal end of an inner shaft <NUM>. More particularly, as best shown in <FIG>, which is a cross-section of inner shaft <NUM> removed from the valve delivery catheter for illustrative purposes only, a pullwire lumen <NUM> is formed in a sidewall of the inner shaft for slidably receiving a pullwire <NUM>. A proximal end (not shown) of pullwire <NUM> extends to handle <NUM> outside of the patient and actuating mechanism (not shown) is provided thereon for pushing and/or pulling pullwire <NUM> as will be understood by one of ordinary skill in the art. Pullwire <NUM> functions to radially deploy and/or collapse displacement component <NUM> as will be explained in more detail herein. Inner shaft <NUM> defines guidewire lumen <NUM> so that valve delivery catheter <NUM> may be tracked over a guidewire.

With additional reference to <FIG>, displacement component <NUM> includes a plurality of spokes 2276A, 2276B, 2276C (collectively referred to as spokes <NUM>) and a planar or flat component <NUM> attached to the plurality of articulating arms or spokes <NUM>. Spokes 2276A, 2276B, 2276C intersect each other at a centerpoint of each spoke as best shown in <FIG>. Collectively, spokes <NUM> form a support frame <NUM> for planar component <NUM> and provide structural support for the planar component. Each spoke <NUM> is formed from a self-expanding material. In an embodiment shown in <FIG>, support frame <NUM> is self-expanding meaning it has a mechanical memory to return to a pre-set configuration. Mechanical memory may be imparted to the spokes <NUM> that form support frame <NUM> by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Each spoke <NUM> has a joint <NUM> at a centerpoint thereon which allows the spoke to bend and collapse into a delivery configuration as shown in <FIG> and <FIG>. To attach or join spokes <NUM> to inner shaft <NUM>, a pin (not shown) may extend through each joint <NUM> to couple the spoke to the inner shaft and also permit the spokes to rotate relative to the pin.

In a first embodiment, spokes <NUM> are shape set or have a mechanical memory to return to the collapsed or delivery configuration thereof. In this first embodiment, pullwire <NUM> applies tension on spokes <NUM> in order to cause them to rise and deploy. When the tension is released, the mechanical memory thereof pulls spokes <NUM> to its collapsed or delivery configuration shown in <FIG> and <FIG>. In a second embodiment hereof, spokes <NUM> are shape set or have a mechanical memory to return to the expanded or deployed configuration thereof. In this second embodiment, pullwire <NUM> applies tension on spokes <NUM> in order to hold them in the delivery or collapsed configuration of <FIG>. When the tension is released, the mechanical memory thereof pulls spokes <NUM> to their deployed or expanded configuration shown in <FIG>. In both embodiments, pullwire <NUM> provides an ability to counter the mechanical memory configuration so that the user may selectively apply a force to expand and also a counter force to collapse displacement component <NUM>.

Planar component <NUM> is a disc and is attached to support frame <NUM> to extend over a distalmost surface of spokes <NUM>. Planar component <NUM> is an expandable mesh or braid component formed of a permeable material in order to allow blood to flow there-through. For example, planar component <NUM> may be formed from a braided structure constructed from a plurality of metallic wires or filaments woven together or a stamped mesh defining a plurality of open spaces <NUM>. Open spaces <NUM> defined by the mesh when planar component <NUM> is expanded allow blood or other fluid to flow there-through during the valve replacement/repair procedure such that the blood flow is not blocked or occluded.

In the unexpanded or delivery state shown in the side views of <FIG> and <FIG>, each spoke <NUM> is bent at its respective joint <NUM> and at least the unattached ends of each spoke <NUM> are disposed within capsule <NUM> of valve delivery system <NUM>. Pullwire <NUM> extends through inner shaft <NUM> via pullwire lumen <NUM>, and then extends to and is attached to each unattached end of each spoke <NUM> as shown in <FIG>. In the expanded or deployed state shown in the side view of <FIG> and the end view of <FIG>, the plurality of spokes <NUM> radially expand such that they are disposed outside of capsule <NUM>. In order to expand or deploy spokes <NUM>, pullwire <NUM> is proximally withdrawn or pulled to cause spokes <NUM> to radially expand similar to an umbrella. When pullwire <NUM> is pulled back, the portions of pullwire <NUM> that extend to each unattached end of each spoke <NUM> are forced in a distal direction and thereby spokes <NUM> radially expand as indicated by directional arrows <NUM> in <FIG>. When in the expanded or deployed state, each spoke <NUM> is substantially straight and is no longer bent at its respective joint <NUM>.

Displacement component <NUM> may be used to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. More particularly, with reference to <FIG>, valve delivery catheter <NUM> is introduced into a ventricle of the heart through a puncture in the ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Valve delivery catheter <NUM> is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adj acent to the apex of the heart as described above. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within delivery the sheath or capsule <NUM>, and displacement component <NUM> is in its delivery or unexpanded state in which the displacement component has a first or unexpanded outer diameter D<NUM>, and each spoke <NUM> is bent at its respective joint <NUM> and at least the unattached ends of each spoke <NUM> are disposed within capsule <NUM> of valve delivery system <NUM>.

With heart valve prosthesis <NUM> still in the delivery configuration, displacement component <NUM> is radially expanded by manipulation of pullwire <NUM>. More particularly, if spokes <NUM> of displacement component <NUM> are shape set or have a mechanical memory to return to the collapsed or delivery configuration thereof, tension on pullwire <NUM> is applied in order to cause spokes <NUM> to rise and radially expand similar to an umbrella such that spokes <NUM> are disposed outside of capsule <NUM>. If spokes <NUM> of displacement component <NUM> are shape set or have a mechanical memory to return to the expanded or deployed configuration thereof, tension on pullwire <NUM> is released in order to permit spokes <NUM> to resume their expanded or deployed configuration as shown in <FIG>. As shown on the partial perspective view of <FIG>, when deployed, each spoke <NUM> is substantially straight and is no longer bent at its respective joint <NUM> when displacement component <NUM> is expanded or deployed.

Valve delivery catheter <NUM> is then maneuvered and advanced towards the annulus of the native valve of the heart with displacement component <NUM> in the expanded state. With displacement component <NUM> expanded and disposed outside of capsule <NUM>, displacement component <NUM> displaces or pushes all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM> as shown in <FIG>. When expanded, displacement component <NUM> has the second outer diameter D<NUM> greater than the first outer diameter D<NUM>. The second outer diameter D<NUM> of expanded displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle.

When displacement component <NUM> approaches the underside of the native mitral valve, it may be desirable to radially collapse displacement component <NUM> to cross the native mitral valve as shown in <FIG>. If spokes <NUM> of displacement component <NUM> are shape set or have a mechanical memory to return to the collapsed or delivery configuration thereof, tension on pullwire <NUM> is released in order to permit spokes <NUM> to bend and resume their delivery configuration as shown in <FIG>. If spokes <NUM> of displacement component <NUM> are shape set or have a mechanical memory to return to the expanded or deployed configuration thereof, tension on pullwire <NUM> is applied in order to collapse or bend spokes <NUM> into their delivery configuration as shown in <FIG>. Once delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM> is positioned within the annulus of the native mitral valve, heart valve prosthesis <NUM> is then deployed or expanded into apposition with the annulus of the native mitral valve as shown in <FIG>. Alternatively, the native mitral valve may be crossed with displacement component <NUM> in its expanded or deployed configuration and heart valve prosthesis <NUM> may be deployed with displacement component <NUM> still expanded.

As an alternative to planar component <NUM>, as depicted in <FIG>, a displacement component <NUM> may be utilized that includes a plurality of articulating arms or spokes 3276A, 3276B, 3276C (collectively referred to as spokes <NUM>) and an annular component <NUM> that encircles and is attached to the unattached ends of spokes <NUM>. In this embodiment, spokes 3276A, 3276B, 3276C have the same structure and are deployed in a similar manner as spokes 2276A, 2276B, 2276C. Annular component <NUM> is a ring comprised of a self-expanding material or an inflatable balloon, and functions to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of the valve delivery catheter. Spokes 3276A, 3276B, 3276C provide structural support for annular component <NUM>.

Further, although <FIG> were described with utilization of pullwire <NUM> to mechanically deploy spokes <NUM>, other deployment mechanisms may be utilized to cause spokes <NUM> to radially expand as described herein. For example, hydraulic or pneumatic means may be used to deploy spokes <NUM> to the expanded or deployed state.

<FIG> illustrate an embodiment of a displacement component <NUM> according to the present invention that may be used in a valve delivery catheter <NUM>. <FIG> is an enlarged sectional view of a distal portion of valve delivery catheter <NUM> with displacement component <NUM> in an unexpanded or delivery state. Valve delivery catheter <NUM> is similar to valve delivery catheter <NUM> described above except that displacement component <NUM> includes a first ring <NUM> comprised of a self-expanding material and a second ring <NUM> comprised of a self-expanding material, first and second rings <NUM>, <NUM> being longitudinally spaced apart and coupled to each other via a plurality of sutures or tethers 3390A, 3390B. Displacement component <NUM> is incorporated onto valve delivery catheter <NUM>, with displacement component <NUM> disposed distal to valve prosthesis <NUM> and compressed within a distalmost end of capsule <NUM> during delivery thereof as best shown in <FIG>, and displacement component <NUM> is deployed prior to valve prosthesis <NUM>.

<FIG> illustrates displacement element <NUM> in an expanded or deployed state and removed from the valve delivery system for illustrative purposes only. First and second rings <NUM>, <NUM> are each annular components of an O-shape. In another embodiment hereof, one or both of first and second rings <NUM>, <NUM> may be a C-shape. First and second rings <NUM>, <NUM> are attached to each other via sutures or tethers 3390A, 3390B which extend between the first and second rings on opposing sides thereof. Sutures 3390A, 3390B may be formed from a monofilament or plastic suture material, such as polypropylene. First and second rings <NUM>, <NUM> also attached to valve delivery catheter <NUM> at all times via sutures or tethers 3390A, 3390B. Sutures or tethers 3390A, 3390B extend proximally to handle <NUM>, for example, within respective or designated lumens (not shown) formed within a sidewall of inner shaft <NUM>, which may be formed via multi-lumen extrusion as known in the art. A suitable mechanism (not shown) on handle <NUM> can allow the operator to retract sutures or tethers 3390A, 3390B in a proximal direction in order to retrieve displacement component <NUM> after valve deployment if desired, as will be described in more detail herein.

<FIG> is a perspective illustration of the distal end of valve delivery catheter <NUM> during deployment of displacement component <NUM>. First ring <NUM> is disposed distal to second ring <NUM>, and thus first ring <NUM> is deployed prior to second ring <NUM>. In <FIG>, first ring <NUM> of displacement component <NUM> is in the expanded or deployed state and second ring <NUM> of displacement component <NUM> is in the unexpanded or delivery state. Deployment of displacement component <NUM> is a two stage or step process, i.e., deployment or expansion of first ring <NUM> and then deployment or expansion of second ring <NUM>, to allow for alignment of displacement component <NUM> before completing deployment of the displacement component. Ring alignment may be adjusted through manipulation of valve delivery catheter <NUM> between ring deployment procedural steps.

Displacement component <NUM> may be used to displace or push all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. As described with respect to <FIG> herein, valve delivery catheter <NUM> is introduced into a ventricle of the heart through a puncture in the ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Valve delivery catheter <NUM> is positioned into the left ventricle via a transapical approach and positioning valve delivery catheter <NUM> within the left ventricle of the heart includes introducing the catheter into the apex of the heart as well as introducing the catheter through a ventricular wall adj acent to the apex of the heart as described above. Heart valve prosthesis <NUM> is in the delivery or collapsed configuration within delivery the sheath or capsule <NUM>, and displacement component <NUM> is in its delivery or unexpanded state in which the displacement component has a first or unexpanded outer diameter D<NUM> and is housed or disposed within a distalmost end of capsule <NUM>. With heart valve prosthesis <NUM> still in the delivery configuration, displacement component <NUM> is radially expanded via retraction of capsule <NUM>. More particularly, capsule <NUM> of valve delivery catheter <NUM> is proximally retracted to expose first ring <NUM> and permit self-expansion thereof. After alignment of first ring <NUM> is verified, capsule <NUM> of valve delivery catheter <NUM> is further proximally retracted to expose second ring <NUM> and permit self-expansion thereof. First and second rings <NUM>, <NUM> of displacement component <NUM> each have a second outer diameter D<NUM> greater than the first outer diameter D<NUM>. Valve delivery catheter <NUM> is then maneuvered and advanced towards the annulus of the native valve of the heart with displacement component <NUM> in the expanded state. With first and second rings <NUM>, <NUM> expanded and released from capsule <NUM>, displacement component <NUM> displaces or pushes all chordae tendineae CT, trabeculae and ventricular bands radially outwards towards the ventricular wall and away from the valve delivery catheter during advancement of valve delivery catheter <NUM>. The second outer diameter D<NUM> of expanded displacement component <NUM> is of a dimension that prevents the displacement component from passing through openings between chordae in a left ventricle. Once delivery sheath or capsule <NUM> containing collapsed heart valve prosthesis <NUM> is positioned within the annulus of the native mitral valve, heart valve prosthesis <NUM> is then deployed or expanded into apposition with the annulus of the native mitral valve. After deployment of heart valve prosthesis <NUM>, displacement component <NUM> is retracted or return back into capsule <NUM> by pulling or proximally retracting sutures or tethers 3390A, 3390B in order to retrieve displacement component <NUM> after valve deployment.

Claim 1:
A delivery system (<NUM>) for delivering a valve prosthesis (<NUM>) to an annulus of a native valve of a heart, the native valve having chordae tendineae, the delivery system comprising:
an inner shaft component (<NUM>) having a distal segment over which the valve prosthesis is loaded in a compressed delivery configuration;
an outer shaft component (<NUM>) slidingly disposed over the distal segment of the inner shaft component for holding the valve prosthesis in the compressed delivery configuration; and
characterized in the delivery system further including a displacement component (<NUM>) configured for displacing chordae tendineae, the displacement component being at the distal portion of the valve delivery system, wherein the displacement component includes a first ring (<NUM>) comprised of a self-expanding material and a second ring (<NUM>) comprised of a self-expanding material, the first and second self-expanding rings being longitudinally spaced apart and coupled to each other via a plurality of sutures (3390A. 3390B).