HEART VALVE REPAIR PROSTHESES, DELIVERY DEVICES AND METHODS

A heart valve prosthesis including separable ventricular and members is provided. The ventricular member has a first hub that has a connection feature. Each of at least three arms are coupled at a first end to the first hub and have a second end opposite the first end. The arms are preloaded toward a location of heart valve leaflet when the ventricular member is implanted. The atrial member has a second hub coupled to a frame array and has a connection feature configured to couple to the connection feature of the first hub for securing the atrial and ventricular members together. The frame array is preloaded toward a location of the heart valve leaflets when the atrial member is implanted. Concavities are formed at the periphery of the frame array to receive the arms of the ventricular member in an engaged configuration. Valve tissue may be trapped between the arms and the concavities.

BACKGROUND OF THE INVENTION

Field of the Invention

This application is directed to heart valve prostheses configured to treat valve regurgitation, preferably without surgery.

Description of the Related Art

Heart valve regurgitation is a condition that arises from various causes in which blood flows backward through the valve when the valve should have prevented such flow. Regurgitation can occur in several valves of the heart, including the mitral valve, the aortic, valve, the pulmonary valve and the tricuspid valve.

The tricuspid valve separates the right lower heart chamber (the right ventricle) from the right upper heart chamber (right atrium). Tricuspid regurgitation is a disorder in which this valve does not close tight enough. This problem causes blood to flow backward into the right upper heart chamber (atrium) when the right lower heart chamber (ventricle) contracts. Tricuspid regurgitation is leakage of blood backwards through the tricuspid valve each time the right ventricle contracts. Tricuspid regurgitation usually results from an enlarged lower heart chamber (called the ventricle) or from any other condition that constrains the blood flow from the right ventricle to the lungs. Sometimes long-standing disorders, such as emphysema or pulmonary stenosis can cause problems that affect the tricuspid valve which is “upstream” from the lungs. To compensate, the right ventricle enlarges so that it can pump harder, which sometimes causes the tricuspid opening to become stretched out and floppy.

Valve repair is the most common surgical treatment for tricuspid valve disease. This procedure can be done alone or in combination with treatments for other heart problems. Tricuspid valve repair using an annuloplasty ring is a common surgical approach for tricuspid regurgitation and may be performed for primary tricuspid disease or for combined cases with other valve surgery (mitral, aortic). Traditional tricuspid valve repair is an open-heart procedure performed through a 6-8 inch incision through the breastbone (sternum).

While transcatheter systems for tricuspid repair have been explored, such systems provide suboptimal acute results, are complex to use, lacks durability, and poses a too high risk of valve thrombosis unless patients are anticoagulated.

SUMMARY OF THE INVENTION

For these reasons, there exists a need for minimally invasive methods of tricuspid valve repair. The present disclosure is directed to valve fixation devices that can be delivered endovascularly.

In one embodiment, a heart valve prosthesis is provided that includes a ventricular member and an atrial member. The ventricular member is configured to be advanced into a ventricle of a heart. The ventricular member has a hub (sometimes referred to as a first hub) that includes one or more slots and an array of arms. The first hub can be configured to be disposed adjacent to the line of coaptation of a first heart leaflet and a second heart leaflet. The first hub can be positioned on the ventricular side of the line of coaptation, within the line of coaptation and/or into the atrial side of the line of coaptation. Each arm of the array of arms can have a first end connected to the first hub and a second end opposite the first end. The second end of one or more arms (e.g., of each arm) can be deflected towards the first hub in a free state. The second ends of adjacent arms are not connected to each other. For example, the second ends of adjacent arms are not connected to each other in the circumferential direction in some embodiments. The arms are not connected to each other along their length between the first end and the second end in some embodiments. One or more of the second ends of the arms can be configured to be placed into direct contact with the first heart leaflet. One or more of the second ends of the arms can be configured to be placed into direct contact with the second heart leaflet. The atrial member is configured to be advanced into an atrium adjacent to the line of coaptation. The atrial member can be positioned across (e.g., spanning the gap between) the line of coaptation of the first and second heart leaflets. The atrial member can be positioned across (e.g., on an opposite side of) the line of coaptation of the first and second heart leaflets from the arms of the ventricular member. The atrial member has a second hub that has one or more, e.g., a plurality of tangs, and an array of petals. The tangs can be configured for locking into the slots of the first hub to engage the second hub with the first hub when the atrial member and the ventricular member are assembled. One or more petal, e.g., each petal, of the array of petals has a base end connected to the second hub and an outer end opposite the base end. The outer end of one or more petal, e.g., each petal, is deflected away from the second hub. One or more adjacent petals, e.g., each adjacent petal, is bounded by a shared inner strut and a separate outer strut forming a concavity at the junction of the shared inner strut and the separate outer strut. The atrial member is separate from and moveable relative to the ventricular member prior to the first hub and the second hub being engaged. In an engaged configuration the arms of the ventricular member are pressed into the concavity of the atrial member.

A ventricular member of a heart valve prosthesis can be provided. A ventricular member or clamp member can have a plurality of arms disposed around a central member. The arms can collectively span two or three heart leaflets. Each arm of the plurality of arms can have a free end deflected towards the central member. The second ends of adjacent arms are not connected to each other. For example, the second ends of adjacent arms are not connected to each other in the circumferential direction in some embodiments. The arms are not connected to each other along their length between the first end and the second end in some embodiments. One or more of the second ends of the arms can be configured to be placed into direct contact with the first heart leaflet. One or more of the second ends of the arms can be configured to be placed into direct contact with the second heart leaflet.

The central member of the ventricular member or ventricular clamp can include a hub. The hub can have slots or tangs for engagement with another valve leaflet capture member, e.g., an atrial clamp.

An atrial member or atrial clamp of a heart valve prosthesis can be provided. The atrial member can be positioned across, e.g., on an opposite side of, the first and second heart leaflets from a mating ventricular member or clamp. The atrial member can have a central member and an array of petals. One or more petal, e.g., each petal, of the array of petals is connected to the central member and has an outer end opposite the central member. The outer end of one or more petal, e.g., each petal, is deflected away from the central member. The petals can include an array of frame members that are symmetrical and symmetrically disposed around a center of the central member of the atrial member. Non-symmetrical (or asymmetrical) frames or symmetrical frames arranged in a non-symmetrical (or asymmetrical) manner can be provided in some embodiments.

One or more adjacent petals, e.g., each adjacent petal, can be bounded by a radial strut adjacent to the central member. The radial strut can be or include a shared inner strut. The petals can be bounded by separate outer struts. A concavity at the junction of the shared inner strut and the separate outer strut.

If provided together in a heart valve prosthesis, the atrial member can be separate from and moveable relative to the ventricular member prior to implantation. The central members of the ventricular and atrial members can be engaged following movement of the ventricular and atrial members together. In an engaged configuration, arms of the ventricular member can be pressed against the atrial member, e.g, into a concavity formed between adjacent petals of the atrial member, such that a valve leaflet is compressed therebetween. In an engaged configuration, the atrial member can deflect one or more arms such that a valve leaflet is compressed therebetween. In an engaged configuration, the petals of the atrial member and the arms of the ventricular member can both deflect such that a valve leaflet is compressed therebetween.

A portion of the ventricular member can be positioned across the line of coaptation of the first and second heart leaflets (e.g., spanning the gap between the leaflets) when the ventricular member is engaged with the atrial member. The atrial member can include slots or tangs to engage the ventricular member. If the atrial member includes tangs, the tangs can be configured for locking into slots disposed on the central member of the ventricular member when the atrial member and the ventricular member are assembled. If the atrial member includes slot, the slots can be configured for locking into tangs projecting from the central member of the ventricular member when the atrial member and the ventricular member are assembled.

In another embodiment, a heart valve prosthesis is provided that includes a ventricular member and an atrial member. The atrial member is separate from and moveable relative to the ventricular member, e.g., prior to assembly. The atrial member and the ventricular member are configured for assembly in the heart in some embodiments. For example, a connection feature of a first hub of the ventricular member and a connection feature of a second hub of the atrial member can be engaged inside the heart. The ventricular member can be configured to be advanced into a ventricle of a heart. The ventricular member can have a first hub having a slot and at least three arms. The first hub can be configured to be disposed adjacent to the line of coaptation of a first heart leaflet and a second heart leaflet. Each arm can have a first end connected to the first hub and a second end opposite the first end, the second ends of adjacent arms are not connected to each other. One or more of the second ends are configured to be placed into direct contact with the first heart leaflet and one or more of the second ends are configured to be placed into direct contact with the second heart leaflet. The atrial member can be configured to be advanced at least partially into an atrium across the line of coaptation of the first and second heart leaflets. The atrial member has a second hub that has a tang. The atrial member has a frame array. The tang of the second hub is configured for locking into the slot of the first hub to engage the second hub with the first hub when the atrial member and the ventricular member are assembled. The frame array includes a plurality of frames. The frames have a base portion connected to the second hub and an outer portion opposite the base portion. Each frame of the frame array has two shared struts and two dedicated strut portions. The two shared struts are connected to the second hub at a first end and forming the base portion. The two dedicated strut portions attached at a second end of each of the shared struts. One or more frame, e.g., each frame, encloses an approximately quadrilateral shaped area. Adjacent frames are connected by shared struts. Adjacent frames form a concavity there between. In an engaged configuration, the arms of the ventricular member are pressed into the concavities of the atrial member.

In another embodiment, a heart valve prosthesis includes a ventricular member and an atrial member. The atrial member can be separate from and moveable relative to the ventricular member, e.g., prior to engagement. During engagement of the ventricular member to the atrial member, a centering feature of the atrial member guides an arm of the ventricular member into a predefined position and/or orientation as connection feature(s) (e.g., tangs) of one of the ventricular and atrial members (e.g., a hub of the atrial member) engage(s) connection feature(s) of the other of the ventricular and atrial members (e.g., slots of a first hub of the ventricular member). The ventricular member is configured to be advanced into a ventricle of a heart. The ventricular member includes a first hub and at least three arms. The first hub has a slot. The first hub is configured to be disposed adjacent to the line of coaptation of a first heart leaflet and a second heart leaflet. Each arm of the at least three arms has a first end connected to the first hub and a second end opposite the first end. One or more of the second ends of the arms is configured to be placed into direct contact with the first heart leaflet and one or more of the second ends configured to be placed into direct contact with the second heart leaflet. The atrial member is configured to be advanced into an atrium and to be positioned across the line of coaptation. The atrial member includes a second hub and at least one centering feature. The second hub has a connection feature (e.g., a tang) for locking into a connection feature (e.g., the slot of the first hub) when the atrial member and the ventricular member are assembled. The at least one centering feature is configured for centering at least one arm of the ventricular member. During an engagement of the ventricular member to the atrial member, the centering feature of the atrial member guides the arm of the ventricular member into a predefined position and/or orientation as the connection feature (e.g., tangs) of the second hub engage the connection features (e.g., slots) of the first hub.

In variations of the foregoing, a span of one or more of the arms adjacent to the second ends can be configured to be placed into direct contact with the first heart leaflet. A span of one or more of the arms adjacent to the second ends can be configured to be placed into direct contact with the second heart leaflet. A span of one or more of the arms extending from the second ends can be configured to be placed into direct contact with the first heart leaflet. A span of one or more of the arms extending from the second ends can be configured to be placed into direct contact with the second heart leaflet. An entirety of a span of one or more of the arms can be configured to be placed into direct contact with the first heart leaflet. An entirety of a span of one or more of the arms can be configured to be placed into direct contact with the second heart leaflet.

Further embodiments of the foregoing can provide the first hub of the ventricular member and the second hub of the atrial member with other connection features. For example, the first hub of the ventricular member can be provided with one or more tangs, e.g., a plurality of tangs, and the second hub of the atrial member can have one or more slots, e.g. a plurality of slots. The tangs of the first hub can be configured for locking into the slots of the second hub to engage the first hub with the second hub when the ventricular member and the atrial member are assembled. In other embodiments, the first hub of the ventricular member can be configured with one or more tangs, e.g., a plurality of tangs, and with one or more slots, e.g., a plurality of slots. The second hub of the atrial member can be configured with one or more tangs, e.g., a plurality of tangs, and with one or more slots, e.g., a plurality of slots. Slots and tangs can alternate about the periphery of the first hub. Slots and tangs can alternate about the periphery of the second hub. Alternate around the hubs in this context can include providing a first connection feature followed by a second connection feature of a different type spaced apart, e.g., circumferentially spaced apart from the first connection feature.

In another embodiment, a system for delivering a heart valve prosthesis is provided. The system can include a delivery device and a prosthesis. The delivery device can include a delivery handle, a plurality of removable lockouts, a sheath assembly, and a guide handle. The delivery handle can include a housing and a plurality of sliders disposed in the housing. The plurality of removable lockouts can be configured to prevent motion of the sliders in a first state and to allow a range of motion in a second state. The sheath assembly can include an outer sheath, an inner sheath disposed within the outer sheath, the outer sheath moveable relative to the inner sheath. The guide handle can be configured to retract the outer sheath. The prosthesis can include a ventricular member and an atrial member. The ventricular member can include at least three arms, each arm having a first end coupled to a hub. The atrial member can include a hub configured to couple with the hub of the ventricular member and at least one centering featuring comprising a concavity for centering at least one of the at least three arms of the ventricular member. The delivery handle can be configured to control movement and positioning of the prosthesis within a heart by movement of the sliders and lockouts.

In variations of the foregoing, the system can include one or more of the following features. The system can include a nosecone coupled to a distal end of the outer sheath. The nosecone can include a plurality of slits configured to open the nosecone to allow the prosthesis to exit the outer sheath. The nosecone can comprise a flexible tip configured to expand to allow the prosthesis to exit the outer sheath. The nosecone can surround the outer sheath and be configured to be retracted to allow the prosthesis to exit the outer sheath. The system can include an inflatable balloon disposed within the outer sheath, the inflatable balloon configured to be inflated to prevent the prosthesis from exiting the outer sheath and configured to be deflated to allow the prosthesis to exit the outer sheath. The system can include a source of fluid coupled with the housing and configured to supply a fluid to a space disposed between an inner surface of the outer sheath and an outer surface of the inner sheath. The system can include a source of fluid coupled with the housing and configured to supply a fluid to a plurality of spaces disposed between an inner surface of the outer sheath and an outer surface of the inner sheath. The system can include a plurality of fluid sources coupled with a plurality of spaces disposed between an inner surface of the outer sheath and an outer surface of the inner sheath, one of the fluid sources of the plurality of fluid sources supplying fluid to each one of the spaces between the inner surface of the outer heath and the outer surface of the inner sheath.

In another embodiment, a method for performing a procedure in a heat is provided. The method can include advancing a delivery catheter to the heart, passing a ventricular member through the delivery catheter and into a ventricle of the heart, the ventricular member comprising at least three arms, each arm having a first end coupled to a hub, passing an atrial member through the delivery catheter and into an atrium of the heart, the atrial member comprising at least one centering feature comprising a concavity for centering at least one of the at least three arms of the ventricular member, aligning the ventricular member and the atrial member such that tissue is compressed between the ventricular member and the atrial member, inserting the hub of the ventricular member to a hub of the atrial member, and securing the ventricular member to the atrial member.

In variations of the foregoing, the system can include one or more of the following features. The delivery catheter can be coupled to a delivery handle, the delivery handle comprising a plurality of sliders disposed in a housing and a plurality of removable lockouts configured to prevent motion of the sliders in a first state and to allow a range of motion in a second state. The sliders and lockouts can be configured to pass the ventricular member and the atrial member through the delivery catheter. The tissue can be the tricuspid valve. The method can include supplying a fluid to a space disposed within the delivery catheter via a source of fluid coupled to a delivery handle coupled to the delivery catheter. The method can include supplying a fluid to a plurality of spaces disposed within the delivery catheter. The method can include opening a plurality of slits in a nosecone coupled to a distal end of the delivery catheter, wherein opening the slits allows the ventricular member and the atrial member to pass through the distal end of the delivery catheter.

In another embodiment, a method for performing a procedure in a heat is provided. The method can include passing a ventricular member through the delivery catheter and into a right ventricle of the heart, the ventricular member comprising at least three arms, each arm having a first end coupled to a hub, positioning the ventricular member against a first side of a leaflet of a tricuspid valve, passing an atrial member through the delivery catheter and into a right atrium of the heart, the atrial member comprising at least one centering feature comprising a concavity for centering at least one of the at least three arms of the ventricular member, positioning the atrial member against a second side of the leaflet of the tricuspid valve, aligning the ventricular member and the atrial member such that leaflet of the tricuspid valve is compressed between the ventricular member and the atrial member, inserting the hub of the ventricular member to a hub of the atrial member, and securing the ventricular member to the atrial member.

In variations of the foregoing, the system can include one or more of the following features. The delivery catheter can be coupled to a delivery handle, the delivery handle comprising a plurality of sliders disposed in a housing and a plurality of removable lockouts configured to prevent motion of the sliders in a first state and to allow a range of motion in a second state. The sliders and lockouts can be configured to pass the ventricular member and the atrial member through the delivery catheter. The method can include supplying a fluid to a space disposed within the delivery catheter via a source of fluid coupled to a delivery handle coupled to the delivery catheter. The source of fluid can be configured to supply a fluid to a plurality of spaces disposed within the delivery catheter. The method can include opening a plurality of slits in a nosecone coupled to a distal end of the delivery catheter, wherein opening the slits allows the ventricular member and the atrial member to pass through the distal end of the delivery catheter. The delivery catheter can be advanced through a femoral vein. The delivery catheter can be advanced through a jugular vein.

More detailed descriptions of various embodiments of valve repair devices and methods useful to treat patients suffering from valve regurgitation are set forth below.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

This application is directed to heart valve repair prostheses, delivery devices and methods for delivering and implanting the same.FIG.1illustrates one embodiment of a heart valve prosthesis100and a delivery system400. The heart valve prosthesis100and other embodiments disclosed herein provide more reliable valve leaflet capture than in other prior device and methods. The components and assemblies have less, minimally, or a-traumatic device materials and configurations to enhance safety. As discussed further below, the devices and methods disclosed herein provide improved treatment for severe degrees of tricuspid valve regurgitation. The heart valve prosthesis100includes an atrial member212with a cover223and a ventricular member112configured to avoid chordea in delivery and assembly and to provide atraumatic interaction leaflet tissue. These components and assemblies, discussed in greater detail below, are informed by a physiologic approach to treating tricuspid valve regurgitation which incorporates an understanding of the tricuspid anatomy.

I. HEART VALVE REGURGITATION AND ITS ENDOVASCULAR TREATMENT

As discussed above, poor coaptation of valve leaflets is a major problem.FIGS.1A-1Cillustrate this problem and a technique for correcting it.FIG.1Ais a schematic representation of a heart10in normal diastole. The heart10consists of four chambers with the tricuspid valve12located between the right atrium14and the right ventricle16.FIG.1Billustrates the heart10in normal systole, showing that the leaflets LF1, LF2, LF3of the tricuspid valve12are contacting each other where they meet. This leaflet contact seals the right atrium14from the right ventricle16along the length of the leaflets, sometimes called a line of coaptation.

FIG.1Cschematically illustrates a malfunctioning tricuspid valve12. This view shows the tricuspid valve from above, e.g., the view from the right atrium.FIG.1Cillustrates that during systole there are large gaps G between the leaflet edges, with a complete lack of coaptation along these leaflets.FIG.1Dillustrates how heart valve prostheses described herein improve the valve function in systole. In this view, the heart valve prosthesis100is disposed within and captures the leaflets of the tricuspid valve. Specifically, the heart valve prosthesis100is applied such that each leaflet is engaged by a frame member or petal of the atrial member212of the heart valve prosthesis100. Also, each leaflet of the valve is engaged by arms of the ventricular member112. The second end136of the arms and the frames222or petals236of the atrial member212grip the first heart leaflet LF1, LF2, LF3to reduce or eliminate regurgitation through the valve12.FIG.1Dpresents a simplified version of the heart valve prosthesis100, showing three frames222and three arms124. The heart valve prosthesis100can include two frames222and two arms124or more than three frames222and three arms124, e.g., any number of arms including four, five six, seven, eight, nine, ten, eleven, twelve or more than twelve frames222and four, five six, seven, eight, nine, ten, eleven, twelve or more than twelve arms124, or any combination of these numbers of frames and arms. In some embodiments, there are more frames222than arms124, e.g., twelve frames222and six arms124or other combinations of frames and arms from the foregoing numbers of each of these components to form the heart valve prosthesis100. In some embodiments, there are more arms124than frames222, e.g., twelve arms124and six frames222or other combinations of frames and arms from the foregoing numbers of each of these components to form the heart valve prosthesis100. The heart valve prosthesis100has a cover223blocks flow through a substantial portion of the valve12even if the uncovered portions of the valve along the lines of coaptation do not close. The result is that the volume of backflow (regurgitation) is reduced or prevented in systole. The leaflets can still separate in diastole sufficiently to allow blood to flow from the right atrium to the right ventricle.

The present disclosure illustrates a closure of at least a central zone of leakage or cause the uncovered portions of the valve12close in systole. The resulting repaired valve is much more capable of providing healthy blood flow through the heart10.

II. HEART VALVE REPAIR SYSTEM

Having illustrated one example of treating the tricuspid valve12with an embodiment of the heart valve prosthesis100, additional details of various embodiments of the heart valve prosthesis100and a treatment system50for treating patients with heart valve regurgitation will now be discussed.FIG.1illustrates the treatment system50that includes a heart valve prosthesis100coupled with a delivery system400. The heart valve prosthesis100is particularly well suited for treating tricuspid valve regurgitation, as described above.

The heart valve prosthesis100includes a ventricular member112and an atrial member212. The ventricular member112is configured to be advanced by the delivery system400into a ventricle of a heart, e.g., the right ventricle. The atrial member212is configured to be advanced by the delivery system400into an atrium of a heart, e.g., the right atrium. A further discussion of the delivery system400is set forth below.

The heart valve prosthesis100is further illustrated inFIGS.2-5.FIG.2show a collapsed configuration of the ventricular member112. The ventricular member112includes a hub116, which is sometimes referred to herein as a first hub116. The ventricular member112includes one or more slots120formed through the first hub116. The slots120are one example of a connection feature of ventricular member112of the heart valve prosthesis100. The ventricular member112includes array of arms124. The ventricular member112can include at least two, three, four, five, six, seven, eight, nine, ten, eleven or twelve arms124. The ventricular member112can include no more than two, three, four, five, six, seven, eight, nine, ten, eleven or twelve arms124. The ventricular member112can include only two, only three, only four, only five, only six, only seven, only eight, only nine, only ten, only eleven or only twelve arms124. The arms124have a first end132connected to the first hub116. The arms124have a second end136opposite the first end132.FIG.2shows that in one embodiment, the array of arms124can include some arms124that are longer than other arms. A shorter arm124can have a first end132′ and a second end136′. The second end136′ can be located closer to the first hub116than is the second end136of the longer arms124. Each arm124of the array of arms124can include an elongate body130disposed between the first end132and the second end136.

FIGS.3and3Ashow that the first end132of one or more arm, e.g., each arm, of the ventricular member112, can be deflected towards the first hub116in a free state140. For example, the first hub116can be arranged along a lumen axis LA1. The lumen axis LA1can be an axis in the center of a lumen within the first hub116.FIG.3Ashows the first hub116and a single arm124for simplicity. The arm124has the first end132and the second end136as discussed above and extends along the elongate body130. The first end132can be the end of the elongate body130coupled or attached to the first hub116. The first end132can be coupled or attached to a distal end of the first hub116. The elongate body130can include a first curved segment130aadjacent to or extending from the first end132and a second segment130badjacent to or extending from the first segment130a. The second segment130bcan be a straight segment. The second segment130bcan be curved. In one embodiment, the second segment130bis curved in the same direction as the first segment. If curved, the second segment130bcan have a much larger radius of curvature than the first segment130a. The radius of curvature can be about 0.25 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, or in a range including any of the foregoing dimensions as end points. The size of the radius of curvature can be a balance between being as small as possible but also large enough to minimize strains during manufacturing or implantation. An arm axis AA1can be defined along the elongate body130. In one embodiment, the arm axis AA1can be a straight line aligned with or parallel to the longitudinal axis of the second segment130b. In one embodiment, the arm axis AA1can be a tangent line to the second segment130bof the elongate body130. An angle of deflection a can be defined between the lumen axis LA1and the arm axis AA1. The angle of deflection a can be about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, or within a range defined between any of the foregoing angles.

The angle of deflection a is such that a projection of the second end136of the elongate body130toward the first hub116is closer to a proximal end of the first hub116than is a projection of another part of the elongate body130. A projection of the second end136of the elongate body130toward the first hub116can be disposed closer to a proximal end of the first hub116than is an end of the second segment130badjacent to the first segment130a. A projection of the second end136of the elongate body130toward the first hub116can be disposed closer to a proximal end of the first hub116than is the first segment130a. A projection of the second end136of the elongate body130toward the first hub116can be disposed closer to a proximal end of the first hub116than is the first end132.

FIGS.3and3Aillustrate that the slots120can be an elongate, e.g., rectangular, opening in the side surface of the first hub116. The slots120can be elongate along the direction of the lumen axis LA1. The slots120can have axial edges aligned with the lumen axis LA1and circumferential edges that follow the curvature of the first hub116. As discussed further below, the slots120can engage connection features of the atrial member212when the heart valve prosthesis100is assembled within a heart of a patient.

The ventricular member112can be formed in any suitable manner. In one embodiment, the ventricular member112is formed from a tubular body. The elongate body130of each of the arms124can be formed by cutting or removing material between an elongate body130and one or more adjacent elongate bodies130.FIG.2shows that the ventricular member112can have a tubular configuration when in an unexpanded or compressed state. The outward facing surfaces of the elongate body130can be aligned with a projection of the outer surface of the first hub116. The outward facing surfaces of the elongate body130can be disposed radially inward of a projection of the outer surface of the first hub116. These configurations facilitate the use of a cylindrical catheter body of the delivery system400to maintain the arms124in an unexpanded or compressed state for delivery and thereafter extend the ventricular member112out of the cylindrical catheter body for expansion in a ventricle, as discussed further below.

In one embodiment, the ventricular member112can be formed using or can include a shape memory material. Such a material can enable the arms124to self-expand from the configuration ofFIG.2into the configuration ofFIG.3. One such material is a nickel-titanium alloy know as Nitinol. A shape memory material that is configurated to be highly elastic (e.g., super-elastic) can allow the configuration ofFIG.3to be attained by removing a constraint (e.g., an outer catheter body of the delivery system400) from a position radially outward of the arms124. Once the arms124are unconstrained, the arms can move from the compressed state ofFIG.2to the expanded state ofFIG.3. Shape memory materials also can be configured to be actuated by ambient temperature. The material used to form the ventricular member112, e.g., the arms124, can be configured such that the compressed state ofFIG.2is provided at room temperature and the expanded state ofFIG.3is provided by raising the temperature of the arms124to a higher temperature, e.g., the body temperature of the patient.

FIG.2shows that the arms124can have an atraumatic configuration. In one embodiment, an atraumatic configuration is provided by configuring the second end136of one or at least some (e.g., all) of the arms124with an atraumatic tip. The atraumatic tip can have an enlarged portion136aand a narrowed portion136b. The enlarged portion136acan be the same size or width (e.g., dimension transverse to a longitudinal axis of the arms124) and can be enlarged relative to the narrowed portion136b. The enlarged portions136acan be larger than the dimension transverse to a longitudinal axis of the arms124of the narrowed portion136b. The enlarged portion136acan spread the contact load to valve leaflets on the ventricular side thereof to reduce the trauma thereto. The narrowed portion136band the varying length of adjacent arms124allow for enhanced packing of the arms. In particular, the narrowed portion136bcan be configured to receive the enlarged width of the enlarged portion136aas seen inFIG.2. As a result, a larger number of arms124can be included in the ventricular member112of a given diameter than if the enlarged portion136aof some of the arms124were not nested within the narrowed portion136bof the adjacent arms124.

The ventricular member112can be configured such that the second end136of the arms124can lie on or adjacent to an arcuate profile, such as a circle C1. The circle C1can have a diameter of about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, or in a range including any of the foregoing dimensions as end points, e.g., about 15 mm to about 25 mm. The arcuate profile, e.g., circle C1connecting the second ends136of the arms124is less than an arcuate profile, e.g., circle C2(seeFIG.5) connecting the outer ends of petals236or the tips of the atrial member212. The relative size for the circle C1and circle C2can be seen inFIGS.6D and6Fand is discussed further below.

In the illustrated embodiment ofFIG.3, the second ends136of adjacent arms124are not connected to each other. One or more of the second ends136configured to be placed into direct contact with the first heart leaflet LF1. One or more of the second ends136configured to be placed into direct contact with the second heart leaflet LF2Optionally, one or more of the second ends136configured to be placed into direct contact with the third heart leaflet LF3. In some embodiments, the entire elongate body130of adjacent arms124remain unconnected to the adjacent arms. The heart leaflets LF1, LF2, LF3are connected to heart tissue by chordae tendineae, or chordae. The chordae are elongate fibrous chords spanning the ventricle. The un-connected nature of the arms124allows the arms to expand between adjacent chordate without becoming tangled therein. More specifically, the arms124can transition from extending in a direction aligned with the lumen axis LA1to a direction corresponding to the pre-loaded configuration. This can include swinging through an angle of more than 90 degrees. The slender and un-connected configuration of the arms124allows the arms to move between adjacent chordae without entanglement.

FIGS.4and5show additional details of the atrial member212. The atrial member212is configured to be advanced into an atrium and to extend across a line of coaptation LOC of a first heart leaflet LF1, a second heart leaflet LF2, and/or a third heart leaflet LF3. The atrial member212is separate from and moveable relative to the ventricular member112prior to connecting or engaging the first hub116to a second hub216of the atrial member212to assemble the heart valve prosthesis100. The engagement of the first hub116and the second hub216causes the arms124of the ventricular member112to be pressed into concavities of the atrial member212. The concavities can be disposed at an outer periphery of the atrial member212.

The atrial member212includes a frame array220including a plurality of frames222that can be at least partially, e.g., entirely enclosed by a cover223. The cover223can include a membrane formed of a material such as ePTFE or Dacron. By positioning the cover223on the atrial side of the valve (on the atrial member212), the cover223will not interfere with the chordae. The cover223and the frame array220provide a closed cell frame structure that creates more consistent loading around the perimeter of the atrial member212. The cover223can be used to seal the portion of the valve over which the cover and the frames222extend. In some cases the cover223promotes endothelialization over the atrial member212. The cover223can cause some load to be applied between the tips of the frames222. The cover223can partially cover concavities between the frames222(discussed below) and can receive tips of the arms124of the ventricular member112with valve tissue sandwiched therebetween in some locations upon deployment.

The frames222can be configured as petals236. The petals236can include a repeating pattern of structures about the circumference. The petals236can be positioned edge to edge. The petals236can share a common edge or strut. The petals236can be symmetrical about a bi-secting radius of each petal. In some embodiments, the petals236are symmetrical about a radius extending from a center of an inner portion of the petals236adjacent to the second hub216to a tip of the petals236. The tip of the petals236can be a radially outermost portion of each petal. Where the cover223is provided, it can extend across the structure of the petal enclosing some or each petal. The cover223can have an arcuate, e.g., circular, outer periphery as shown inFIG.1. The cover223can span between tips of the petals236at the periphery of the atrial member212.

FIGS.4and5show that each of the frames222can have a base portion224and an outer portion226. The base portion224of each frame222can include one or more shared struts228. The shared struts228can have opposing circumferential edges bounding a portion of adjacent frames222. A single frame222can be bounded by two adjacent shared struts228. A single frame222can be bounded by dedicated strut portions229. A single frame222can include a first shared strut228and a first dedicated strut portion229extending from an outer end of the first shared strut228to a tip of the frame222. The single frame222can further be bounded by a second dedicated strut portion229. The second dedicated strut portion229can extend from the tip of the frame222to an outer end of a second shared strut228. The second shared strut228is disposed adjacent to the first shared strut228opposite a radius extending to the tip of the frame222. The first and second shared struts228can be coupled at inner ends to the second hub216or to another frame member that is coupled to the second hub216.

Each frame222encloses an approximately quadrilateral shaped area238in one embodiment. As discussed above, adjacent frames are connected by shared struts228. Adjacent frames222form a concavity240therebetween. The concavity240provides an area for receiving or nesting of the arms124in the atrial member212. The atrial member212is separate from and moveable relative to the ventricular member112prior to the first hub116and the second hub216being engaged. The concavity240can be centered on a longitudinal axis of the shared struts228in one embodiment. In an engaged configuration the arms124of the ventricular member112are pressed into the concavity240of the atrial member212. This relationship is shown inFIGS.6D and6F and7B-7D.

FIG.5shows that the quadrilateral shaped area238can have a kite shape. For example, in some embodiments the shared struts228can have a length that is greater than the length of the dedicated strut portions229. In some embodiments the shared struts228extend away from a central radial axis of the frames222by a first angle and the dedicated strut portions229extend away from the central radial axis by a second angle that is greater in magnitude than the first angle. The kite shaped area can be defined by a first isosceles triangular shaped area and a second isosceles triangular shaped area. The first isosceles triangular shaped area can be defined by an axis extending between outer ends of the shared struts228and by the two shared struts228of an individual frame222. The second isosceles triangular shaped area can be defined by the axis extending between outer ends of the shared struts228and by the dedicated strut portions229of an individual frame222. The first isosceles triangle can be disposed between the second isosceles triangle and the second hub216. The first isosceles triangular shaped area can have a first height greater than a second height of the second isosceles triangle. The first height can be in a range of about 5 mm to about 9 mm. The second height can be in a range of about 2 mm to about 6 mm. The height of the first isosceles triangular shaped area can be about 20 percent, about 30 percent, about 40 percent, about 50 percent, about 60 percent, about 70 percent, about 80 percent, about 90 percent, about 100 percent, about 150 percent, about 200 percent, or in a range including any two of the foregoing percentages listed as end points larger than the height of the second first isosceles triangular shaped area. The height of the first isosceles triangular shaped area can the same or less than the height of the second first isosceles triangular shaped area. The magnitude of the height of the first isosceles triangular shaped area can be about twice the magnitude of the length of the base of the first isosceles triangular shaped area. The magnitude of the height of the second isosceles triangular shaped area can be about the same as the magnitude of the length of the base of the second isosceles triangular shaped area.

FIG.5Ais a schematic diagram illustrating a preloaded state of the atrial member212. In the preloaded state, the frames222are oriented toward the location of the leaflets when the atrial member212is positioned or implanted in the heart. The atrial member212can provide that the frames222extend from a distal end of the second hub216outward and distally. In one embodiment, the amount of the extent in the distal direction can be defined by an angle of deflection B. The angle of deflection B can be about 85 degrees, about 80 degrees, about 75 degrees, about 70 degrees, about 65 degrees, about 60 degrees, about 55 degrees, about 50 degrees, about 45 degrees, or within a range defined between any of the foregoing angles. The magnitude of the angle of deflection B can be the same as the magnitude of the angle of deflection a of the arms124. The magnitude of the angle of deflection B can be greater than the magnitude of the angle of deflection a of the arms124. The magnitude of the angle of deflection B can be less than the magnitude of the angle of deflection a of the arms124.

FIG.3Ashows that the arms124are bent or are inclined toward the first hub116when the ventricular member112is disengaged from the atrial member212.FIG.3Aillustrates a preloaded state in which the arms124are oriented toward the location of the leaflets when the ventricular member112is positioned or implanted in the heart.FIG.5Ashows that the frames222or the petals236are bent or are inclined away from the second hub216(e.g., toward the leaflet location) when the atrial member212is disengaged from the ventricular member112. The arms124and the base portion224are each elastic, e.g., formed of a nickel-titanium alloy (e.g., Nitinol) or similar highly elastic material, such that the arms124and the base portion224apply a load when they are deflected away from the at rest states ofFIGS.3A and5A. If the arms124are deflected to higher angles α the arms124will apply a proximally oriented load to the leaflets of the valve when implanted. If the frames222are deflected to higher angles ß the frames222will apply a distally oriented load. As discussed further below, in one embodiment the process of assembling the first hub116of the ventricular member112to the second hub216of the atrial member212will cause the arms124to deflect to higher angles α and the frames222to deflect to high angles ß. Thus, in this embodiment, both the arms124and the frames222will apply compression loads on one or more of the first heart leaflet LF1, the second heart leaflet LF2, and optionally the third heart leaflet LF3compressed therebetween. In other embodiments, one of the arms124and the frames222are more deflectable or one of the arms124and the frames222is not deflectable under the loads involved in assembling the heart valve prosthesis100. Thus, the load applied to one side of the leaflets LF1, LF2, LF3can be different from the load applied to the other side of the leaflets LF1, LF2, LF3.

FIGS.5B and5Cshow additional configurations of frames222A,222B. The frames222A have a concavity240A that is centered on a central radial axis (dashed line) of the frames. As with the frames222, the frames222A are formed by radially outward extending dedicated strut portions229. The concavity240A can be formed by undulating shape of portions of the dedicated strut portions229disposed away from the shared struts228. The concavity240A can be located between the adjacent dedicated strut portions229of the frames222A. The frames222B have a concavity240B that is centered on a central radial axis (dashed line) of the frames222B. As with the frames222, the frames222B are formed with dedicated strut portions229that extend from outer ends of the shared struts228. The dedicated strut portions229of the frames222B extend radially inward from the outer ends of the shared struts228to form the concavity240B along the central radial axis of the frames222B. The concavity240B can be formed by straight inwardly extending dedicated strut portions229of the frames222B.

FIG.5shows that the frames222of the atrial member212can have tips disposed on an arcuate periphery, e.g., a circle C2. The circle C2can be configured to be larger than the circle C1extending between the ends of the arms124of the ventricular member112. The location of the concavity240, concavity240A, or the concavity240B can be disposed at a radial position that is less than the radius of circle C1. Thus the tips of the arms124can be disposed in an annular band between the circumference of the circle C1and the circumference of the circle C2. The circle C2can have a diameter of about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or in a range including any of the foregoing dimensions as end points.

The atrial member212also can have connection feature. In one embodiment, a tang (or a plurality of tangs)252is (or are) configured for locking into the slot(s)120of the first hub116to engage the second hub216with the first hub116when the atrial member212and the ventricular member112are assembled. The tangs252can be configured to engage a connection feature of the ventricular member112, e.g., the slots120. In one embodiment, the first hub116is received in the second hub216. The tangs252are biased inwardly and will deflect inward into the slots120when the tangs252are aligned with the slots120. In another embodiment, the second hub216is received in the first hub116. The tangs252are biased outwardly and will deflect outward into the slots120when the tangs252are aligned with the slots120.

The heart valve prosthesis100preferably has a centering feature to cause the connection features of the ventricular member112and the atrial member212to be aligned with each other upon engagement of the members with each other. In one example, as the arms124are moved into the concavity240the sloping side surfaces of the dedicated strut portions229guide the arms124into the radially inner-most portion of the concavity240. This position corresponds to an alignment of the tangs252with the slots120. For example, in one embodiment, the delivery system400is configured such that the atrial member212is held rotationally stationary and the frames222or petals236can apply a load to the arms124which thereby apply a moment to the first hub116to rotate the first hub116relative to (e.g., within or over) the second hub216to rotate the slots120into rotational alignment with the tangs252. In another embodiment of the delivery system400the ventricular member112is maintained rotationally stationary and the arms124apply a force to the frames222or to the petals236which thereby apply a moment to the second hub216to rotate the second hub216relative to (e.g., within or over) the first hub116such that the tangs252move into rotational alignment with the slots120. Thus, the arms124can act as a centering feature, the concavity240can also act as a centering feature or the arms124and the concavity240can also act as a centering feature of the heart valve prosthesis100.

As with the ventricular member112, the atrial member212can be compressed into a cylindrical configuration as seen inFIG.4. The cylindrical configuration allows the atrial member212to be disposed in a catheter body of the delivery system400as discussed below. As discussed above, the atrial member212can be formed of an elastic material, e.g., a nickel-titanium material such as Nitinol, to be able to self-expand to the configuration ofFIG.5.

FIGS.8A-9Billustrates additional embodiments of the heart valve prosthesis that can incorporate a plug or other flow control for a heart valve prosthesis. The prosthesis can include a ventricular member112A or a ventricular member112B illustrated thereby. The ventricular member112A and the ventricular member112B can be similar to the ventricular member112except as described differently below.

The ventricular member112A can include a deflectable flow control member150disposed within the first hub116. The deflectable flow control member150can be configured as a one way valve with deflectable flaps154configured to span the lumen of the first hub116. The deflectable flaps154can be deflected as shown inFIG.8Ato accommodate an inner shaft404, which can be part of the delivery system400as discussed further below. The deflection of the deflectable flaps154allows the inner shaft404to be disposed through the ventricular member112A during delivery. The inner shaft404can be removed during or at the end of deliver and assembly of the heart valve prosthesis100incorporating the ventricular member112A.FIG.8Bshows that after the inner shaft404is removed from the lumen of the first hub116the deflectable flaps154extend across the lumen and seal against each other. The pressure on the distal side of the ventricular member112A (i.e., in the right ventricle) will exceed that of the pressure on the proximal side of the ventricular member112A and when that condition is present the deflectable flaps154will remain closed. The deflectable flow control member150is advantageous in that the valve would allow access through the heart valve prosthesis100for reintroducing the inner shaft404or performing other procedures through the heart valve prosthesis100.

FIGS.9A-9Billustrate the ventricular member112B in more detail. A compressible flow control member162is provided within the lumen of the first hub116. The compressible flow control member162can be a compressible foam material, a woven Dacron material, or other similar material. The compressible flow control member162can be provided with a small opening allowing the inner shaft404to be passed therethrough. After delivery of the ventricular member112B the inner shaft404can be removed from the lumen of the first hub116of the ventricular member112B. The pressure in the ventricle will cause the small opening to collapse and to close, plugging the lumen of the first hub116. The compressible flow control member162is advantageous in that after the inner shaft404is removed a complete closure of the lumen through the first hub116(and through the heart valve prosthesis100) is provided regardless of the pressures on opposite sides of the ventricular member112B. The compressible flow control member162can initially have an opening, e.g., not be fully closed when the inner shaft404is not disposed therethrough. A small size opening may become occluded with tissue over time. In some cases the ventricular member112can be provided without any collapsible flow control member and yet can be closed due to tissue growth over time.

III. DELIVERY SYSTEMS AND METHODS

FIGS.1and6A-6Fillustrate various embodiments of the delivery system400for delivering and assembling the heart valve prosthesis100within a patient's heart, e.g., in the tricuspid valve between the right atrium and ventricle. The delivery system400is configured to be delivered over a guidewire GW as seen inFIGS.1and6A-6E. In some techniques, the guidewire GW can be advanced into the ventricle and held at rest (e.g., parked) in the ventricle to provide a rail for rapid and accurate advancement and deployment of the prosthesis100. In other techniques, a guide catheter (not shown) can be advanced into the ventricle and held at rest in the ventricle to provide a rail for rapid and accurate advancement and deployment of the prosthesis100. A guide catheter can be used alone or in combination with a guidewire to facilitate deployment. The delivery system400includes a distal portion402A and a proximal portion402B. An outer sheath406can extend to a distal tip410. The proximal portion402B can include a guide handle412and a delivery handle414. The guide handle412can be coupled with a proximal end of the outer sheath406. The delivery handle414can extend through the guide handle412and through the outer sheath406to components of the heart valve prosthesis100.

FIG.6Ashows an aspect of a method of using the delivery system400to deliver the heart valve prosthesis100. The guide handle412can be manipulated to advance the outer sheath406through the venous vasculature over a guidewire to the heart. The outer sheath406can be advanced into the right atrium. Continued advancement of the outer sheath406can move the distal tip410across the line of coaptation LOC of the tricuspid valve of the patient into the right ventricle. This is the position illustrated inFIG.6A. The delivery handle414controls movement and relative position of the components of the heart valve prosthesis100, e.g., during movement of the guide handle412and the outer sheath406. The delivery handle414can be held stationary while the guide handle412is pulled back to expose the implant. In various methods, the heart valve prosthesis100is placed in one of the peripheral regions of the tricuspid valve.

FIG.1Dshows that the heart valve prosthesis100can be implanted between the first heart leaflet LF1and the second heart leaflet LF2. The placement of the heart valve prosthesis100inFIG.1Dcan be such that the heart valve prosthesis100is not disposed across the gap G between the first heart leaflet LF1and the third heart leaflet LF3unaffected. The placement of the heart valve prosthesis100inFIG.1Dcan be such that the heart valve prosthesis100is not disposed across the gap G between second heart leaflet LF2and the third heart leaflet LF3unaffected. In other techniques, the heart valve prosthesis100can be placed between the first heart leaflet LF1and the third heart leaflet LF3. In other techniques, the heart valve prosthesis100can be placed between the second heart leaflet LF2and the third heart leaflet LF3. The appropriate position of the heart valve prosthesis100can be determined prior to or during the procedure, e.g., using an echocardiogram. The appropriate position of the heart valve prosthesis100can be achieved by manipulating the distal tip410and a distal length of the outer sheath406within a peripheral region of a portion of the tricuspid valve between two of the three leaflets.

FIG.6Bshows that relative movement between the outer sheath406and the ventricular member112can expose the ventricular member in the right ventricle. The outer sheath406can be moved proximally by withdrawing the guide handle412as indicated by the arrow A1. The delivery handle414can be held stationary while the guide handle412is moved as indicated by the arrow A1in one technique. As the outer sheath406moves proximally, the distal tip410is withdrawn proximally until the distal tip410is disposed proximal of the ventricular member112. The distal tip410can be withdrawn into the right atrium while the delivery system400maintains the ventricular member112in position, e.g., the ventricular member can be maintained at a same position while the distal tip410is moved proximally. In another technique the guide handle412can be held stationary and the delivery handle414can be moved distally to advance the ventricular member112distally out of the distal tip410of the outer sheath406.

As discussed above, the ventricular member112can include arms124that can be configured to self-expand into the position or configuration seen inFIG.6B. The arms124can be arranged such that the second ends136thereof are not connected to each other. The arms124are thus slender members that can expand between the network of chordae that transverse the right ventricle to move the leaflets LF1, LF2, LF3as the heart beats. This configuration of the ventricular member112mitigates or eliminates the risk of entanglement between the ventricular member112and the chordae. In one form of the delivery system400the rotational position of the delivery handle414can be maintained as the outer sheath406is moved relative to the ventricular member112such that the ventricular member does not rotate as it is expanded.

FIG.6Cshows a further aspect of a method of using the delivery system400. The outer sheath406can be moved relative to an inner sheath408, e.g., moved proximally as indicated by the arrow A2, until distal tip410is proximal of the atrial member212. The atrial member212can be disposed distally of the inner sheath408such that when exposed, the atrial member212can expand within the atrium. Proximal movement along the arrow A2can be caused by corresponding movement of the guide handle412as indicated by the arrow A2.FIG.6Cshows that the ventricular member112and the atrial member212can be expanded within the heart prior to being engaged with each other. The ventricular member112can be preloaded, e.g., with the arms124deflected or oriented toward the first hub116of the ventricular member as discussed in connection withFIG.3A. The frame array220can be preloaded, e.g., with the frames222or petals236deflected or oriented away from the second hub216as discussed in connection withFIG.5A. The angle of deflection or orientation of the arms124and the frame array220can be greater in the state ofFIG.6Cthan when the ventricular member112and the atrial member212are engaged with each other.

FIG.6Dshows a technique for grasping one or more, e.g., two or three, leaflets. The delivery handle414can be modified by removing a first lockout432from a first slider436and a second slider440. The first lockout432is configured to block movement of the first slider436and the second slider440prior to being removed from the delivery handle414.FIG.6Cshows that the first lockout432can fill a space in the delivery handle414in which the first slider436and the second slider440can move if the first lockout432is not positioned in that space. Upon removal of the first lockout432the first slider436and the second slider440can be moved together as indicated by the arrow A3. This movement can cause a corresponding movement according to arrow A3moving the atrial member212toward and into engagement with the ventricular member112. Following the movement of the first slider436and the second slider440the ventricular member112and the atrial member212can be engaged, trapping leaflet material therebetween. At least one of the tips (e.g., the second end136) of the arms124can be received in the concavities240of the frame array220. The ventricular member112and the atrial member212can still be connected to the delivery system400in this part of the method of using the delivery system400.FIG.6Dshows that a second lockout444can maintain the relative position of the first slider436and the second slider440during the movement according to the arrow A3.FIG.6Dalso shows that a third lockout452can be provided to maintain the relative position of a third slider456and a fourth slider460, the operation of which will be discussed further below.

As discussed above the tangs252can be configured to engage windows, e.g., the slots120, of the ventricular member112. The tangs252can be deflected inwardly in a free state. Prior to engaging the first hub116with the second hub216(e.g., advancing the first hub116into the second hub216) the tangs252can be deflected inwardly such that a minimum distance between the tangs252is less than an outer diameter of the first hub116. The tangs252can be rotationally aligned with the slots120such that as the movement according to the arrow A3occurs the tangs252can be advanced to a proximal edge of the first hub116. As the proximal edge engages the inner side of the tangs252the tangs can be deflected outwardly by the first hub116. Continued relative movement of the first hub116and the second hub216to each other can be provided, e.g., according to the arrow A3, until the tangs252are disposed over the slots120. When disposed over the slots120, the tangs252will no longer be held in a radially outwardly deflected position and can deflect inwardly into the slots120to securely connect the ventricular member112to the atrial member212.

As discussed above, the concavities240can receive the arms124(in at least some cases with valve tissue therebetween) and as continued movement of the ventricular member112and the atrial member212together occurs, the concavity240can provide at least some rotational movement of the members to each other. This rotational movement can reduce or eliminate any misalignment of the tangs252to the slots120that could complicate engagement of these connection features.

FIG.6Eshows a further aspect of a method of using the delivery system400. The second lockout444is removed allowing for relative movement of the first slider436relative to the second slider440. The first slider436can be moved toward the second slider440as indicated by the arrow A4. Such movement corresponds to withdrawing a distal portion of the inner sheath408to allow an outer gripper407of the delivery system400to expand. Prior to expansion thereof, the outer gripper407is engaged with the second hub216, e.g., with windows250of the second hub216disposed around the tangs252. Retracting the inner sheath408from the outer gripper407can allow the outer gripper407to self-expand out of engagement with the window250.

FIG.6Fshows disengagement of the heart valve prosthesis100from the delivery system400. The disengagement can be achieved by removing the third lockout452from the delivery handle414. The third lockout452can prevent relative movement of the third slider456to the fourth slider460. After the third lockout452is removed the fourth slider460can be moved proximally as indicated by the arrow A5retracting the inner shaft404to a position proximal of the inner gripper409. Prior to such movement the inner shaft404is disposed in a space between the inner gripper409to maintain the inner gripper409in the slots120to retain the ventricular member112in position on the delivery system400. Movement along arrow A5causes the inner shaft404to move out of position between the inner gripper409. Such movement allows the inner gripper409to self-collapse to the configuration shown inFIG.6F. This configuration provides a maximum outer dimension of the inner gripper409that is less than the inner diameter of the first hub116or in some embodiments moved out of the slots120. In some configurations the inner gripper409do not fully deflect out of the slots120when the inner shaft404is withdrawn. In such configurations the inner gripper409may be sufficiently deflectable when the inner shaft404is withdrawn that the inner gripper409will be deflected by the heart valve prosthesis100as it moves off of the delivery system400. For example the heart valve prosthesis100can be firmly engaged with two or more of the heart leaflets LF1, LF2, LF3such that the leaflets retain the heart valve prosthesis100upon proximal movement of the guide handle412to withdraw the delivery system400from the heart.

FIG.6Gillustrates an additional embodiment of a delivery handle414A. The features described with reference toFIG.6Gare optional. The delivery system400and in particular the delivery handle414A can include one or more tubes or fluid sources441(e.g., tube441a, tube441b, tube441c, tube441d) configured to act as flushing sources for flushing catheter bodies of the system400. The tubes441a-dcan allow for the delivery system400to be flushable with a fluid such as saline or any other biocompatible fluid. The fluid can flow through the tubes441a-441dand delivery device and eventually into the blood and expelled. The tubes441a-dwhen pressurized can assist in removing air from the delivery system400, which can prevent the air from entering the bloodstream. Additionally, the tubes441a-dwhen pressurized can prevent/remove blood from entering areas of the delivery device400. The tubes441a-441dwhen pressurized can prevent/reduce friction when moving the sliders436,440,456,460to move different catheter bodies of the system400.

The tubes441a-dcan each be in fluid communication with a different annular space within the delivery system400that can correspond to the slider to which each tube441a-dis connected. For example, tube441acan be connected to the first slider436. The tube441bcan be connected to the second slider440. The tube441ccan be connected to the third slider456. The tube441dcan be connected to the fourth slider460.

The first tube441acan be fluidically connected to a first annular space that extends from first slider436toward or to the distal tip410of the delivery system400. The second tube441bcan be fluidically connected to a second annular space that extends from the second slider440toward or to the distal tip410of the delivery system400. The third tube441ccan be fluidically connected to a third annular space that extends from the third slider456toward or to the to the distal tip410of the delivery system400. The fourth tube441dcan be fluidically connected to a fourth annular space that extends from the fourth slider460toward or to the distal tip410of the delivery system400. The annular spaces can be separate from each other. The annular spaces can be embedded within each other. For example, the fourth annular space can enclose the third annular space. The third annular space can enclose the second annular space. The second annular space can enclose the first annular space. In another embodiments, the fourth annular space can extend through the third annular space. The fourth and the third annular spaces can then extend through the second annular space. The fourth, third, and second annular spaces can extend through the first annular space. One or more of the annular spaces can be disposed between an inner surface of the outer sheath406and the outer surface of the inner sheath408. One or more of the annular spaces can be disposed between an outer surface of the inner shaft404and the inner surface of the inner sheath408.

A syringe442can be used to push the fluid through the tubes441a-d. In some embodiments, more than one syringe442can be used. For example, one or a separate syringe can be used for each tube441a-d. Fluid can be selectively inserted one or more annular spaces at a time. Fluid can be inserted into more than one or all annular spaces simultaneously. The fluid can exit the syringe442and travel through a manifold443. The manifold443can direct the fluid to the appropriate tube441a-dand corresponding annular space. The fluid will then travel through the annular spaces of the delivery system and ultimately out the distal end. As described above, this can flush any air out of the delivery system, can prevent or remove blood from the system, and/or can reduce friction or can eliminate friction when moving the sliders436,440,456,460. When present the manifold443can be supplied with a continuous supply of fluid, e.g., a drip of saline from an elevated saline bag.

In some embodiments, each tube441a-dcan be connected to a flow regulator, to the manifold443and/or to an IV fluid source. The IV fluid source can be an IV bag fed by gravity, a pressurized bag, and/or a fluid pump. The flow regulator, manifold, and IV fluid source can be configured such that each tube441a-dreceives a fixed flow rate for flushing. This can be beneficial when all tubes441a-dare connected together flushing and can allow for flow to be preferentially directed to the tube441a-dwith least resistance and bypass more restrictive tubes441a-d.

In another embodiment, a single infusion supply tube can be provided, such as by causing one of the tubes441a-441dto be in fluid communication with each interstitial space between adjacent layers of the system400. This approach benefits from simplicity but may require a higher infusion pressure to counter resistance in certain interstitial spaces of the system400.

FIGS.8A-9Bhave been discussed above in connection with ventricular member112A and the ventricular member112B which are configured to plug a lumen of the first hub116. The plug can be achieved during the technique illustrated inFIG.6F. In particular, as the fourth slider460is withdrawn according to arrow A5the inner shaft404is withdrawn from within the lumen of the first hub116of the ventricular member112B. This allows the deflectable flow control member150, e.g., the deflectable flaps154, of the ventricular member112A to extend out into the lumen of the first hub116. As the fourth slider460is withdrawn according to arrow A5the inner shaft404is withdrawn from within the lumen of the first hub116of the ventricular member112B. This allows the compressible flow control member162of the first hub116of the ventricular member112B to extend out into the lumen of the first hub116. The control of flow in the ventricular member112A is immediate when the deflectable flaps154contact each other. The ventricular member112A can allow for re-crossing the lumen of the first hub116. The ventricular member112A can allow for re-crossing the lumen of the first hub116in one technique. The control of flow in the ventricular member112B can be increasing over time as the compressible flow control member162absorbs blood which may become embedded in pores of the member162.

FIG.7Ashow engagement of the heart valve prosthesis100with heart tissue in one experiment. The heart valve prosthesis100is depicted from the atrial sides of the valve. The second hub216is seen disposed around the first hub116, both of which are on the atrial side of the line of coaptation.

FIG.7Bshows the same heart valve prosthesis100engaged with heart tissue.FIG.7Bis a view of from the ventricular side of a valve to which the prosthesis100has been applied, with a chordae tendineae CT in the foreground. The second end136are shown engaged with the concavity240. Leaflet tissue is trapped between the arms124and the frame array220. In some applications one or more region of the heart valve prosthesis100may be disposed in the line of coaptation LOC, e.g., not engaged with either leaflet as seen at the 2 o'clock position. The atrial member212can be covered by the cover223as discussed above such that backflow can be reduced, minimized or prevented even for portions of the heart valve prosthesis100where leaflet tissue is not trapped between an arm124and concavity240or other portion of the frame array220.

FIG.7Cshows that in some applications a portion spanning an angle of about 120 degrees of the circumference of the heart valve prosthesis100can be provided in which direct engagement is provided between the arms124and the concavities240of the frame array220, e.g., no valve tissue is trapped in this spanning portion. In some embodiments, the arms124can align in the center of the concavities240. In some embodiments, the arms124can be off-center of the concavities240. This can be due to interaction with or interference by tissue or other interferences. The cover223can inhibit back flow over the spanning portion. In other applications a spanning of about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 100 degrees, about 110 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, about 170 degrees, about 180 degrees, or over a range of degrees including any combination of the foregoing numbers as end points. In some applications more than one portion of the circumference of the heart valve prosthesis100can provide direct engagement between the ventricular member112and the atrial member212with portions of the heart valve prosthesis100therebetween engaging valve tissue.

FIGS.10A-10Eillustrate exemplary nosecones to be coupled to or disposed at the distal tip410of the delivery system400. The nosecones can allow the delivery system400to track over a guide wire GW within the vasculature. The nosecones can enable the heart valve prosthesis100to be pre-loaded at the distal end of the outer sheath406. The nosecones can provide an atraumatic tip for the delivery system400so the delivery system400does not catch on or damage the vasculature or leaflets as the tip410traverses the line of coaptation of the valve leaflets. The nosecones can be provided in a location that blocks or otherwise protects the heart valve prosthesis100while the delivery system400is advanced and can be capable of transitioning to a second position or a second configuration that is out of the way of or at least less blocking of the heart valve prosthesis100such that the heart valve prosthesis100can pass through the distal tip410of the outer sheath406.

FIGS.10A-10Billustrate an example embodiment of a nosecone500.FIG.10Aillustrates a nosecone500. The nosecone500can be coupled to the distal tip410of the outer sheath406. The nosecone500can be a distal portion or distal region of the distal tip410. The nosecone500can have a first portion501that extends generally parallel to the outer sheath406. The nosecone500can have a second portion502that extends at an angle relative to the outer sheath406toward a central axis of the sheath406to form a generally cone or other distally tapered shape. The second portion502can be configured to transition to an open state, as shown inFIG.10B′.

The nosecone500can have a split tip. For example, the nosecone500can have one or more seams or splits504that allow the nosecone500to open away from a central axis. The nosecone500can have a plurality of seams or splits504. For example, one, two, three, four or more seams or splits504. The number of splits504can determine the number of sections505the nosecone500can be split into when in an open state. In some embodiments, the splits504can extend along both the first and second portions501,502of the nosecone500. In some embodiments, the splits504can extend along only the second portion502of the nosecone500.

The splits504of the nosecone500can be secured together with a breakaway retention device or structure. For example, the breakaway retention device or structure can include a series of perforations, a zone provided with a weak adhesive, a zone with scoring along the splits504or any other suitable method. The breakaway retention device or structure can allow the nosecone500to be advanced in or as one piece and breakaway, split apart, or open once or as the heart valve prosthesis100is advanced through the nosecone500. In some embodiments, the advancement of the heart valve prosthesis100can cause the nosecone500to separate at the splits504.

FIGS.10B and10B′ illustrate the nosecone500transitioning from a closed state, position or configuration to an open state, position or configuration. In the closed state, the delivery system400is advanced to the delivery location. The nosecone500is closed to prevent the heart valve prosthesis100from exiting the delivery system400. In the open state, the delivery system400is at the delivery location and the nosecone transitions to an open state to allow for delivery of the heart valve prosthesis100.

The nosecone500can have an interlock508. The interlock508can be configured to retain the nosecone500in a closed state during advancement of the delivery system400. By pushing the distal tip410of the delivery system400into the interlock508, the nosecone500can be held in a closed position. The nosecone500can be opened by releasing the interlock508by withdrawing the distal tip410and pushing the heart valve prosthesis100through the nosecone500. The nosecone500can the open away from the central axis, as designated by arrow2.

FIGS.10C and10C′ illustrate another example embodiment of a nosecone512.FIG.10Cillustrates the nosecone512in a closed state or configuration andFIG.10C′ illustrates the nosecone512in an open state or configuration. The nosecone512can be coupled to the distal tip410of the outer sheath406. The nosecone512can comprise a flexible material. The flexible material can be configured to open or expand as the heart valve prosthesis100passes through the nosecone512. After the heart valve prosthesis100is delivered the nosecone512can revert to its original closed shape.FIG.10C′ shows elastic expansion of the nosecone512, though some deformation is acceptable given that the function of the nosecone is no longer needed after the heart valve prosthesis100has been deployed.

FIGS.10D and10D′ illustrate another example embodiment of a nosecone516.FIG.10Dillustrates the nosecone516in a closed state or configuration andFIG.10D′ illustrates the nosecone512in an open state or configuration. The nosecone516can be configured as an additional outer sheath disposed around outer sheath406. The nosecone516can have a tip portion and an outer sheath portion. The tip portion and outer sheath portion can enclose the outer sheath406. The nosecone516can slide over the outer sheath406to expose the distal tip410of the outer sheath406. The nosecone516can be withdrawn or pulled back by pulling and stretching the nosecone516over the outer sheath406, as designated by the arrows. In one technique the outer sheath406can be advanced out of the nosecone516. In another technique a simultaneous motion of the nosecone516and the outer sheath406can be provided to move the tip of the sheath406out of the nosecone516. The heart valve prosthesis100can be delivered through the exposed distal tip410of the outer sheath406.

FIG.10Eillustrates another example embodiment of a nosecone520. The nosecone520can be an inflatable balloon tip that is disposed inside or partially coupled to an outer surface of the distal tip410of the outer sheath406. The inflatable balloon tip nosecone520can be inflated by a lumen located inside the distal tip410to prevent the heart valve prosthesis100from exiting the outer sheath406. The inflated tip can block the passage inside the distal tip410to block egress of the prosthesis100. The inflatable tip can have a hemispherical, tapered, or conical profile that can function as a nosecone until delivery of the heart valve prosthesis100. In some embodiments, the heart valve prosthesis100can be advanced along the guidewire GW and the inflatable balloon tip can surround the guidewire and be inflated to prevent the heart valve prosthesis100from exiting the delivery system400. The inflatable balloon tip nosecone520can then be deflated and drawn back past the heart valve prosthesis100such that the heart valve prosthesis100can exit the outer sheath406. Or, the prosthesis100can be advanced over the inflatable balloon tip nosecone520when the nosecone520is deflated.

Among the advantages of the prostheses, delivery systems, nosecones, and methods disclosed herein is the fact that the procedure can be used to deploy the prosthesis without anticoagulation therapy.

Terminology

As used herein, the relative terms “proximal” and “distal” can be defined from the perspective of the implant. Thus, proximal refers to the direction of the portion of the implant to be disposed in the right atrium and distal refers to the portion of the implant to be disposed in the right ventricle.

Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. In addition, the articles “a,” “an,” and “the” as used in this application and the appended claims are to be construed to mean “one or more” or “at least one” unless specified otherwise.

The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 1” includes “1.” Phrases preceded by a term such as “substantially,” “generally,” and the like include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially spherical” includes “spherical.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.

Although certain embodiments and examples have been described herein, it should be emphasized that many variations and modifications may be made to the heart valve prostheses and delivery systems shown and described in the present disclosure, the elements of which are to be understood as being differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.

Moreover, while illustrative embodiments have been described herein, it will be understood by those skilled in the art that the scope of the inventions extends beyond the specifically disclosed embodiments to any and all embodiments having equivalent elements, modifications, omissions, combinations or sub-combinations of the specific features and aspects of the embodiments (e.g., of aspects across various embodiments), adaptations and/or alterations, and uses of the inventions as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inserting a delivery catheter into a right internal jugular vein” include “instructing insertion of a delivery catheter into a right internal jugular vein.”