Patent Description:
Referring to <FIG>, the heart <NUM> includes four chambers connected by four valves. The upper part of the heart <NUM> includes the left atrium <NUM> and right atrium <NUM>. The lower part includes the left ventricle <NUM> and right ventricle <NUM>. The heart <NUM> and cardiovascular system operates like a closed circuit. The right side of the heart <NUM> receives de-oxygenated blood from the body and delivers the blood through the pulmonary artery <NUM> to the lungs where it becomes re-oxygenated. The oxygenated blood is returned to the left side of the heart <NUM>, referred to as the systemic side, which delivers the oxygenated blood throughout the body.

Blood flow between the heart chambers is regulated by the valves. On the left side of the heart, the mitral valve <NUM> is located between the left atrium <NUM> and the left ventricle <NUM> and the aortic valve <NUM> is located between the left ventricle <NUM> and the aorta <NUM>. On the right side of the heart <NUM>, the pulmonary valve <NUM> is located between the right ventricle <NUM> and the pulmonary artery <NUM> and the tricuspid valve <NUM> is located between the right ventricle <NUM> and the right atrium <NUM>.

All four of heart valves are passive one-way valves with "leaflets" which open and close in response to differential pressures. For example, in a healthy heart during systole the left ventricle <NUM> contracts and pushes blood out the aortic valve <NUM>. In turn, the pressure in the left ventricle <NUM> causes the mitral valve <NUM> to close thereby preventing blood from going back into the left atrium <NUM> during systole.

A significant population will acquire valve disease in their lifetime. Congenital heart disease is also a significant problem. Patients with valvular disease have abnormal anatomy and/or function of at least one valve. Congenital valve abnormalities may be tolerated and/or treated palliatively for some years before developing into a life-threatening problem in later years. However, congenital heart disease may present life-threatening risk without notice. Patients may acquire valvular disease from rheumatic fever, heart failure, degenerative leaflet tissue, bacterial infection, and more.

Valvular disease may be caused by several factors as shown in <FIG> shows a healthy mitral valve <NUM>. Referring to <FIG> show a diseased mitral valve <NUM>. The valve <NUM> in <FIG> suffers from insufficiency, also referred to as regurgitation. Such a valve <NUM> does not fully close and allows blood to flow retrograde. In this case, blood will flow back into the left atrium <NUM> during systole. <FIG> shows a mitral valve <NUM> with stenosis. Such a valve <NUM> does not open properly. Some valves <NUM> can have concomitant insufficiency and stenosis. Other diseases may also be present, such as Barlow's disease, which prevent the valve <NUM> from functioning properly. These diseases reduce cardiac output and force the heart <NUM> to work harder, thus increasing the risk of heart failure and chordae failures.

While medications may be used to treat the disease, in many cases the defective valve may need to be repaired or replaced at some point during the patient's lifetime. The native valve can be replaced with a mechanical valve or tissue valve. Mechanical valves have a disc or other member which opens and closes. Although mechanical valves are formed of biocompatible materials, they carry an increased risk of clotting. Thus, patients usually need to take anticoagulants for the remainder of their lives, which presents additional complications. Tissue valves can be formed of human or animal tissue, as well as polymeric materials. Tissue valves, unlike mechanical valves, do not typically require long-term use of anti-coagulants, but because they are formed of a living tissue they are not as widely available nor do they last as long as mechanical valves. Common tissue valves include porcine aortic valves mounted within a stent-like structure.

More recently there has been increased interest in less invasive procedures for implantation of prosthetic valves. One type of percutaneous procedure involves using a catheter to place a prosthetic valve inside of a diseased or injured heart valve.

Existing percutaneous procedures for valve repair still face many challenges. These challenges have limited the adoption of transcatheter procedures to certain patient populations and anatomies. Thus far, transcatheter devices are largely focused on aortic valve procedures and the sickest patient populations who may not be able to tolerate surgery. There is a continuing need for improved transcatheter devices which meet or exceed the performance and safety of surgical valves. Percutaneous valve replacement has also been limited to aortic valve procedures. While a large segment of the population suffers from tricuspid and mitral valve disease, the anatomy and function of these valves present challenges to transcatheter replacement. The aortic valve can be accessed via the femoral artery whereas the mitral valve, for example, typically requires a transseptal approach. The mitral valve anatomy presents more complexities to transcatheter procedures than the aortic valve. For example, as shown in <FIG>, the mitral valve <NUM> includes two asymmetrical leaflets 4a, 4b and an irregularly-shaped annulus 4c. The mitral valve <NUM> also varies far more considerably patient-to-patient than the aortic valve. For these and other reasons, surgical replacement and percutaneous repair thus far are the only widely-available commercial treatments for mitral valve disease.

<CIT> discloses an apparatus for repairing or replacing a defective cardiac valve including an anchor having a double helix configured to engage the cardiac valve leaflets of a diseased or defective cardiac valve, and a replacement valve body disposed in an expandable stent configured to be disposed within the anchor so that the anchor limits expansion of the expandable stent. The expandable stent of the replacement valve body may be self-expanding or mechanically expanded, e.g., using a balloon catheter or catheter-based mandrel and the valve body may be formed of animal tissue or a synthetic fabric.

<CIT> discloses an implant for repairing and/or replacing functionality of a native mitral valve and configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve is implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

<CIT> discloses a covering layer for a transcatheter heart valve configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted.

Further aspects and preferred embodiments of the invention are defined in the dependent claims. Any aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims are provided for illustrative purposes.

The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:.

The devices and methods of the present disclosure have other features and advantages which will be apparent from or are set forth in more detail in the accompanying drawings, which are incorporated in and form a part of this specification, and the following Detailed Description, which together serve to explain the principles of the present invention.

In the following detailed description, reference is made to the accompanying figures, which form a part hereof. In the figures, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, figures, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the scope of the appended claims. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof, within the scope of the appended claims. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method (unclaimed) or process (unclaimed) disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments, however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of a diseased native valve of the heart, for example a mitral valve. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.

For convenience in explanation and accurate definition in the appended claims, the terms "up" or "upper", "down" or "lower", "inside" and "outside" are used to describe features of the embodiments with reference to the positions of such features as displayed in the figures.

In many respects the modifications of the various figures resemble those of preceding modifications and the same reference numerals followed by subscripts "a", "b", "c", and "d" designate corresponding parts.

Turning now to the drawings, wherein like components are designated by like reference numerals throughout the various figures, attention is directed to <FIG>. <FIG> shows a human heart <NUM> and the blood flow pathways through the four chambers of the heart. <FIG> is a human heart <NUM> showing the mitral valve <NUM>, aortic valve <NUM>, and aorta <NUM>. The mitral valve <NUM> includes two leaflets 4a, 4b. The anterior (aortic) leaflet 4a is adjacent the aorta <NUM>. The posterior (mural) leaflet 4b is remote from the aorta <NUM>. The aortic valve <NUM> includes three leaflets. In the current view, the heart <NUM> is in systole with the aortic valve <NUM> open and the mitral valve <NUM> closed. Whereas <FIG> illustrates a healthy heart <NUM>, <FIG> illustrate exemplary mitral valve <NUM> disease states which may be addressed by the prosthetic valve in accordance with the present disclosure. The prosthetic valve may also be used to treat functional regurgitation such as functional mitral regurgitation (FMR).

<FIG> show an exemplary valve prosthesis <NUM> (also referred to herein as "valve device") for replacement of a diseased mitral valve in accordance with the present disclosure. The illustrated valve prosthesis <NUM> comprises a frame structure <NUM>, a valve segment <NUM>, and an anchor <NUM>. <FIG> show the valve prosthesis <NUM> in an expanded, deployed state. <FIG> show the frame structure <NUM> without the valve segment <NUM>. The frame structure <NUM> is in a collapsed state in <FIG> and an expanded state in <FIG>. The anchor <NUM> is shown in a deployed state.

The exemplary valve prosthesis <NUM> will now be described with reference to <FIG>. In the illustrated embodiment, valve prosthesis <NUM> is configured for replacement of a native mitral valve. Valve <NUM> includes a frame structure <NUM>, valve segment <NUM>, and anchor <NUM>. In the illustrated embodiment, the anchor includes a wire <NUM> formed in a helical or spiral shape around the frame structure.

Exemplary frame structure <NUM> is configured like a stent. The frame has an expanded state and a collapsed or compressed state. The compressed state is sized and dimensioned for percutaneous insertion and the expanded state sized and dimensioned for implantation in a native valve of a patient. In various embodiments, the frame structure <NUM> comprises an expanded outer periphery and a compressed outer periphery when subject to an external radial force, the compressed outer periphery being slightly smaller in diameter than the expanded outer periphery. The frame structure <NUM> is shown in the expanded, deployed state in <FIG>. The frame structure <NUM> is shown in the collapsed, delivery state in <FIG>.

The exemplary frame structure <NUM> is a scaffold in a diamond pattern formed from a shape memory material (e.g. NiTi). One of ordinary skill in the art will appreciate from the description herein that many other structures, materials, and configurations may be employed for the frame structure <NUM>. For example, the frame structure <NUM> may be formed of a polymer of sufficient elasticity. The frame structure <NUM> may be formed of a combination of a metal and polymer, such as a metal (e.g. shape memory material) covered in polymer. The frame structure <NUM> may include a variety of patterns besides diamond shapes.

Valve prosthesis <NUM> includes a valve segment <NUM> within the frame structure <NUM>. The exemplary valve segment <NUM> is expandable and collapsible. In the illustrated embodiment, the valve segment <NUM> is affixed within the frame structure <NUM> and expands and collapses with the frame structure <NUM>. Valve segment is used somewhat interchangeably with prosthetic valve leaflet and generally refers to the prosthetic leaflets and frame. As used herein, "prosthetic valve" may refer to all manner of prosthetic and artificial replacement valves including tissue (biological) valves, tissue-engineered valves, polymer valves (e.g. biodegradable polymer valves), and even certain mechanical valves.

In the illustrated embodiment, frame structure <NUM> is a closed frame such that blood flow is forced through valve segment <NUM> therein. One or more skirts and/or seals may help force blood through valve segment <NUM>.

Valve segment <NUM> can be configured as would be understood by one of skill from the description herein. The valve segment <NUM> can be similar to existing transcatheter valves. The valve segment <NUM> can be similar to existing surgical tissue valves, and mechanical valves. In various embodiments, the valve segment <NUM> includes leaflets <NUM> formed of multi-layered materials for preferential function. At least one leaflet <NUM> may have an inner layer and an outer layer. In various embodiments, the leaflet <NUM> is connected to a valve structure which in turn is connected to the frame structure <NUM>. The valve structure may be connected to the frame structure <NUM> before or after the frame structure <NUM> has been deployed adjacent a native valve. In various embodiments, the leaflet <NUM> is attached to the frame structure <NUM> directly. The leaflet <NUM> may have an inner layer and an outer layer, with the outer layer attached to the frame structure <NUM>. The leaflet <NUM> may be attached to an end of the frame structure <NUM>. Alternatively, or in combination, the leaflet <NUM> may be attached to an intermediate portion of the frame structure <NUM>. In various embodiments, the valve segment <NUM> includes a plurality of leaflets <NUM>, such as two, three, or more leaflets. In the illustrated embodiment, the valve segment <NUM> includes three leaflets <NUM> which are attached to frame structure <NUM>. An exemplary leaflet <NUM> is shown in <FIG>. The leaflet <NUM> is concave to permit flow in one direction. In particular, flow in one direction causes the leaflet(s) <NUM> to deflect open and flow in the opposite direction causes the leaflet(s) <NUM> to close.

Turning back to <FIG>, and more particularly <FIG>, an exemplary anchor <NUM> comprises a helical member being a wire formed in a helical shape, having a free end <NUM>. The other end of the wire <NUM> is attached to a top end of frame structure <NUM>. In the illustrated embodiment, one end of the wire <NUM> is fixed to a strut of the frame structure <NUM>. This end can be attached by suitable means as would be understood by one of skill in the art from the description herein including, but not limited to, a weld, an adhesive, and a mechanical fastener. The helical wire <NUM> is attached to the frame structure only at the location of the second end.

Although referred to as an anchor, one will appreciate that anchor <NUM> does not require performing an anchor function in the traditional sense. As will be described in more detail below, the anchor guides valve prosthesis <NUM> into a desired position within a native valve. The anchor <NUM> may also mitigate against undesired entanglement and disturbances to the chordae tendineae and valve leaflets of the mitral valve.

Wire <NUM> is formed of a material having sufficient rigidity to hold a predetermined shape. In the exemplary embodiment, the wire <NUM> is formed of a shape memory material (e.g. NiTi). It may be desirable for at least an end portion to be relatively rigid such that it can exert a force to move chordae tendineae, while still retaining flexibility to be collapsed within a catheter. In various embodiments, the end portion (including free end <NUM>) only needs sufficient rigidity to hold its shape and will deform under a load. For example, the end portion may be configured with similar rigidity to a guidewire, or slightly stiffer.

The anchor <NUM> comprises a helical member. The helical member is a wire formed in a helical shape. In a configuration not covered by the claimed invention, it can be a flat ribbon. The helical member may comprise a three-dimensional surface as described herein.

In various embodiments, the anchor <NUM> may comprise a first portion comprising the helical wire <NUM> and another portion. Alternatively or in combination, the anchor <NUM> may comprise a plurality of helical wires <NUM>. For example, the anchor <NUM> may comprise at least two helical wires <NUM> having the same or different diameters. Alternatively or in combination, the anchor <NUM> may comprise at least two helical wires <NUM> having the same or different winding pitches.

In various embodiments, the anchor <NUM> may comprise a plurality of anchors, for example a plurality of helical wires <NUM> as described herein.

In the illustrated embodiment, valve prosthesis <NUM> is configured for replacing a mitral valve and free end <NUM> is configured for insertion through a commissure. <FIG> is a schematic of a human heart <NUM> having a mitral valve <NUM>. <FIG> and <FIG> show an exemplary mitral valve <NUM>. As can be seen in the figures, several commissure points (anterolateral commissure 4d and posteromedial commissure 4e) are presented at the ends of the valve leaflets 4a, 4b.

With continued reference to <FIG>, the exemplary free end <NUM> is sized and dimensioned for insertion through one of the commissures. In the various embodiments, the free end <NUM> is configured to be atraumatic to avoid risk of injury to the valve tissue and leaflets. The free end <NUM> may be in the form of a blunt end, a ball tip, a curved tip (e.g., J-tip or pigtail), and other atraumatic shapes. In various embodiments, the free end <NUM> is configured with a sharp end to pierce tissue.

In various embodiments, wire <NUM> has varying stiffness along its length. The wire <NUM> may have two or more segments of differing stiffness and/or the stiffness may transition over its length. In various embodiments, wire <NUM> is attached to frame <NUM> at multiple points such that free end <NUM> is relatively flexible and the wire <NUM> is more rigid along portions where it is attached to the frame structure <NUM>.

In various embodiments, free end <NUM> extends radially outward from frame structure <NUM>, and in particular the remainder of wire <NUM>. As will be described below, the free end <NUM> is configured to encircle a larger radius than the main coils of the wire <NUM>. For example, when the main coils of wire <NUM> have a generally tubular shape, the free end <NUM> may extend radially outward from the tubular shape. When the main coils of wire <NUM> have a generally helical shape, the free end <NUM> may extend radially outward from the helical shape. When the main coils of wire <NUM> have a generally frustoconical shape, the free end <NUM> may extend radially outward from the frustoconical shape. The larger diameter facilitates capturing of the valve leaflets and/or chordae tendineae within the sweep of the free end <NUM> during rotation as will be described in more detail below.

The method (unclaimed) of implanting valve prosthesis <NUM> in accordance with the present disclosure will now be described with reference to <FIG>. Although shown and described with respect to a mitral valve, one will understand that the principles described herein may be applied equally to other atrioventricular valves. Aspects of the procedure, delivery tool, and implanted valve prosthesis are similar to those described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT> and <CIT>.

Prior to implantation, valve prosthesis <NUM> is collapsed and loaded into a delivery device <NUM>, for example, a delivery catheter. The valve system is optionally primed before or after loading into the delivery catheter <NUM>. <FIG> shows a cross-sectional side view of a heart <NUM> with a transseptal puncture <NUM> in the atrial septum thereof. The leaflets <NUM> of valve <NUM> do not fully prolapse and the patient is experiencing regurgitation.

Next, the delivery catheter <NUM> is inserted through an introducer into a vessel. The delivery catheter <NUM> can be guided over a guidewire to a target location using the Seldinger technique. In the illustrated embodiment, the delivery catheter <NUM> is guided to the left atrium <NUM> through a transseptal puncture <NUM> in conventional fasion as shown in <FIG>.

Turning to <FIG>, at this point, the end of the delivery catheter <NUM> is pointed towards the mitral valve <NUM>. Valve prosthesis <NUM> is then pushed out of the distal end of delivery catheter <NUM>. The delivery device <NUM> may comprise an outer catheter <NUM> and an inner catheter or shaft <NUM>. In some embodiments, once the delivery device <NUM> is in position, the delivery tube <NUM> extends out of the outer catheter <NUM> to move valve device <NUM> distally towards the native valve <NUM>. As the valve prosthesis <NUM> comes out from the delivery catheter <NUM>, an anchor <NUM>, such as wire <NUM>, is deployed (e.g., from a straightened shape within the delivery device <NUM>) to its pre-formed deployed shape and wraps around frame <NUM>, which remains in its collapsed state as shown in <FIG>. The valve prosthesis <NUM> is then aligned with the target native valve <NUM> so the axis of the prosthetic valve <NUM> is aligned with a central axis of the native valve <NUM>.

Turning to <FIG>, valve <NUM> is anchored to the native valve <NUM> using exemplary helical wire <NUM>. The valve prosthesis <NUM>-frame <NUM>, wire <NUM>, and valve segment <NUM>-are slowly rotated into the native mitral valve <NUM>. In the illustrated embodiment, a torquer is provided in the delivery catheter <NUM> for rotating valve <NUM>. Free end <NUM> of wire <NUM> is rotated through a commissure and extends below the native valve <NUM> annulus. The valve prothesis <NUM> is further rotated so the free end <NUM> captures the chordae tendineae (also referred to as "papillary muscles") <NUM> and/or native valve leaflets <NUM>. As the wire <NUM> is continually rotated, the chordae tendineae <NUM> are gathered and pulled radially inward. Free end <NUM> has a larger radius than the main body of the helical coil in order to facilitate capture of the chordae tendineae <NUM> during rotation of the valve prosthesis <NUM>. Frame structure <NUM> also moves into the native valve <NUM> as the wire <NUM> is rotated. Valve prosthesis <NUM> is in the correct position when the chordae tendineae <NUM> have been captured to a sufficient degree and/or frame structure <NUM> is in the desired location in the native valve <NUM>. Insertion of the device through the native valve may be facilitated by the natural opening and closing of the native valve during the cardiac cycle. In the illustrated embodiment, the chordae tendineae <NUM> are pulled inwardly into a bunches (best seen in <FIG>). The native valve leaflets <NUM> are also in communication with the helical coil <NUM>. At this stage valve device <NUM> is rigidly anchored adjacent the native valve <NUM> annulus.

If the clinician desires to remove or reposition the valve, the helical wire <NUM> can be counter-rotated to back out the device <NUM> from the native valve <NUM>. The implant rotation procedure can then be repeated.

Frame structure <NUM> is expanded once valve <NUM> is in the desired location as shown in <FIG>. The frame structure <NUM> may comprise a first and second opposite ends, the first end extending above a native valve and the second end extending below the native valve when the frame structure <NUM> is anchored to the native valve <NUM>. In the illustrated embodiment, the frame structure <NUM> is expanded with a balloon <NUM> as shown in <FIG>. In various embodiments, the frame structure <NUM> is self-expanding. The self-expanding exemplary frame structure <NUM> is formed of a shape memory material or any material having superelastic properties. The self-expanding frame structure <NUM> is configured and expands in a similar manner to a self-expanding stent or scaffold. Expanding the frame structure <NUM> comprises removing a sheath (for example, outer sheath <NUM>) of the delivery device <NUM> from the frame structure <NUM>.

Once the frame structure <NUM> is expanded the entire valve assembly <NUM> is released from the delivery catheter <NUM> and the delivery catheter <NUM> is removed as shown in <FIG>. In some embodiments, expansion of the frame structure <NUM> may occur simultaneously with release of the frame structure <NUM> from the delivery catheter <NUM>.

In the illustrated embodiment, the valve structure <NUM> and frame structure <NUM> are deployed together. One of ordinary skill in the art will appreciate, however, that the frame structure <NUM> can be deployed first and then receive the prosthetic valve segment <NUM>.

In various embodiments, valve prosthesis <NUM> does not include a valve segment <NUM>. Instead, the frame structure <NUM> and anchor <NUM> are positioned within the native valve <NUM>. The frame structure <NUM> is configured to receive a valve segment <NUM> delivered separately. In certain embodiments, the frame structure <NUM> can be configured to receive one of several valve sizes and types. In this manner, a clinician can choose the proper valve for the individual patient.

In the illustrated embodiment, the helical wire <NUM> of anchor <NUM> guides the valve system <NUM> along a desired axis into position adjacent the native valve <NUM>. The wire <NUM> also provides an initial anchoring. The valve prosthesis <NUM> is finally anchored when the frame structure <NUM> is expanded within the native valve <NUM>. The frame structure <NUM> dilates the valve leaflets <NUM> and the compressive force fixes the valve prosthesis <NUM> into position. Thereafter tissue ingrowth ensures the valve prosthesis <NUM> remains seated and does not migrate.

The valve device in accordance with the present disclosure provides several advantages over conventional valve systems. Embodiments described herein provide an easy-to-use, repositionable device. Unlike conventional valve systems, the valve prosthesis described herein reduces the risk of injuring or tearing chordae. Typical mitral valve replacement systems involve implanting a prosthetic annulus or ring around the valve. The ring increases the circumference of the valve and risks occluding the entry to the aortic valve. The valve device described herein overcomes these and other problems.

<FIG> illustrates another embodiment in accordance with the present disclosure. A valve prosthesis <NUM>' includes a helical wire <NUM>' and frame structure <NUM>'. Valve structure <NUM>' is similar to valve <NUM> except that valve segment <NUM>' is fixed within a separate end of frame structure <NUM>'. Wire <NUM>' is wrapped around a lower portion of the frame structure <NUM> having a smaller diameter than the upper portion of the frame structure <NUM> to which the valve segment <NUM>' is fixed.

<FIG> illustrate several other embodiments in accordance with the present disclosure. Each of valves <NUM>a to <NUM>f includes a helical wire and frame. Each can optionally include a valve segment within the frame.

<FIG> shows a valve prosthesis <NUM>a which is similar to valve prosthesis <NUM> except that free end 22a includes an atraumatic ball tip. Also, wire <NUM>a has a tubular shape at one end and a frustoconical shape at another end. Frame structure 12a is substantially similar to frame structure <NUM>.

<FIG> shows a valve prosthesis <NUM>b which is similar to valve prosthesis <NUM> except that free end <NUM> has a pigtail tip. Also, wire <NUM>b is attached to an intermediate portion of frame structure 12b instead of an end of the frame structure 12b. Frame structure 12b is substantially similar to frame structure <NUM>.

<FIG> shows a valve prosthesis 10c which is similar to valve prosthesis <NUM> except that frame structure <NUM>c is a tubular structure instead of a scaffold or stent-like structure. The frame structure 12c can be formed of expandable materials such as polyurethane or polycarbonate urethane. The wire 20c is substantially similar to wire <NUM>. The free end 22c is substantially similar to free end <NUM>.

<FIG> shows a valve prosthesis 10d which is similar to valve prosthesis <NUM> except that the anchor <NUM> is formed of a three-dimensional surface 20d instead of a wire <NUM>. Three-dimensional surface 20d comprises a free end 22d, which may be substantially similar to any of the free ends described herein. Frame structure 12d is substantially similar to frame structure <NUM>.

<FIG> shows a valve prosthesis <NUM>e which is similar to valve prosthesis <NUM> except that frame structure 12e has a conical shape instead of a tubular shape. One will appreciate from the description herein that the frame structure <NUM> may take a variety of shapes in accordance with the present disclosure. The wire 20e is substantially similar to wire <NUM>. The free end 22e is substantially similar to free end <NUM>.

<FIG> shows a valve prosthesis 10f which is similar to valve prosthesis <NUM> except that the valve device 10f includes a plurality of wires 20f and 20f. The use of a plurality of wires 20f and 20f' provides increased anchoring security. Because it may be difficult to insert both free ends 22f and 22f', one or both free ends 22f and 22f' may include a sharp point for piercing tissue. In this manner, the sharp end can pierce the valve annulus or leaflets. Barbs or other mechanisms may be employed to increase anchoring of the wire. For example, one or both of the wires 20f and 20F may include a braided surface or barbs to prevent axial dislocation once it is screwed into place.

Claim 1:
A heart valve prosthesis (<NUM>) for replacing a diseased native valve in a heart of a patient, the valve prosthesis having an axis and comprising:
a compressible and expandable frame structure (<NUM>);
a valve segment (<NUM>) disposed within the frame structure (<NUM>), the valve segment comprising a biocompatible one-way valve; and
an expandable anchor (<NUM>) connected to an outer periphery of the frame structure (<NUM>), wherein the anchor comprises a wire (<NUM>) formed in a helical shape around the frame structure (<NUM>), the wire having a free end (<NUM>) and wherein the other end of the helically shaped wire (<NUM>) is attached to a top end of the frame structure (<NUM>);
wherein the valve prosthesis (<NUM>) is configured such that, when the valve prosthesis comes out from a delivery catheter, the anchor (<NUM>) expands to a pre-formed deployed state and wraps around the frame structure (<NUM>), which remains in its collapsed state; and
wherein the free end (<NUM>) of the helically shaped wire (<NUM>) is configured to guide the helically shaped wire through a commissure of a native valve of a patient when the helically shaped wire is rotated.