Aortic valve insufficiency repair device and method

Abstract

The invention relates to aortic valve insufficiency repair equipment and a method. The application relates to methods, systems, and devices for replacing a native heart valve with a prosthetic heart valve and treating valvular insufficiency. In a representative embodiment, a support frame configured for transplantation in a heart valve includes an annular body formed by a plurality of angular struts, the body including a plurality of peaks formed by intersections of respective adjacent struts. The support frame also includes one or more leaflet engagement mechanisms configured to engage leaflets of the heart valve. The support frame can be radially expandable and collapsible.

Description

[0001] This application is a divisional application of divisional application 2021103919569, whose application date is November 21, 2014, and whose name is “Device and method for repairing aortic valve insufficiency”. Divisional application 2021103919569 is a divisional application of 2018112346263, and divisional application 2018112346263 is a divisional application of Chinese patent application 2014800640260. Technical Field

[0002] The present application relates to methods, systems and devices for safely replacing native heart valves with artificial heart valves. Background Art

[0003] For many years, artificial heart valves have been used to treat heart valve disorders. Native heart valves (such as the aortic valve, pulmonary valve, tricuspid valve and mitral valve) play an important function in ensuring that an adequate supply of blood flows forward through the cardiovascular system. Congenital, inflammatory or infectious conditions can cause these heart valves to be less effective. Such conditions can ultimately lead to severe cardiovascular damage or death. For many years, the definitive treatment for such disorders has been surgical repair or replacement of the valve during open heart surgery.

[0004] Recently, transvascular techniques have been developed for introducing and transplanting artificial heart valves using flexible catheters in a less invasive manner than open heart surgery. In this technique, an artificial valve is mounted in a curled state on the end portion of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the catheter tip is then expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted. Alternatively, the valve may have an elastic self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter.

[0005] Balloon-expandable valves are commonly used to treat heart valve stenosis, which is a condition in which the leaflets of a valve (e.g., an aortic valve) are hardened by calcium. The hardened leaflets provide a good support structure on which the valve can be anchored within the annulus. In addition, the catheter balloon can apply sufficient expansion force to anchor the frame of the artificial valve to the surrounding calcified tissue. However, there are several heart conditions that do not involve hardened valve leaflets but are still desirable to be treated by valve replacement. For example, when the aortic valve is not properly closed, aortic insufficiency (or aortic regurgitation) occurs, causing blood to flow back into the left ventricle. One cause of aortic insufficiency is an expanded aortic annulus that prevents the aortic valve from closing tightly. In this case, the leaflets are usually too soft to provide sufficient support for a balloon-expandable artificial valve. In addition, the diameter of the aortic annulus can continue to change over time, making it dangerous to install an artificial valve that is not reliably fixed in the annulus. Mitral insufficiency (or mitral regurgitation) involves these same conditions but affects the mitral valve.

[0006] Self-expanding artificial valves are sometimes used to replace defective native valves with non-calcified leaflets. However, self-expanding artificial valves have some significant disadvantages. For example, once the self-expanding artificial valve is placed in a patient's defective heart valve (e.g., the aortic valve or the mitral valve), it continues to exert an outward force on the valve annulus. This continued outward pressure can cause the valve annulus to further expand, worsening the condition of the valve intended to be treated. In addition, when the self-expanding valve is implanted, the outward biasing force of the valve frame tends to cause the valve to be quickly ejected from the distal end of the delivery sheath.

[0007] When treating aortic insufficiency or mitral insufficiency, the size of the artificial valve to be implanted in the patient can also be problematic. Specifically, the size of the artificial valve used to treat aortic insufficiency or mitral insufficiency is generally larger than the artificial valve used to treat aortic or mitral stenosis. This larger valve size makes the delivery procedure more difficult.

[0008] In addition, many artificial heart valves are held by a stent or frame (i.e., a "pinch") placed in the aortic valve annulus prior to valve implantation, and the valve is configured to clamp the native valve leaflets against the frame. However, such a frame typically requires attachment to a delivery device to hold the frame in place prior to and / or during implantation of the artificial heart valve. This requires that the frame delivery device remain in the patient's body during implantation of the artificial heart valve, which can complicate implantation of the valve.

[0009] Therefore, there is a need for improved methods, systems and devices for delivering expandable artificial heart valves (e.g., balloon-expandable artificial valves). Embodiments of the methods, systems and devices can desirably be used to replace native heart valves that do not have calcified leaflets (e.g., aortic valves with aortic insufficiency). In addition, embodiments of the methods, systems and devices can desirably enable precise delivery of artificial valves and control of the delivery. Summary of the invention

[0010] Aortic insufficiency repair devices improve aortic valve function by reducing the diameter (actual diameter and / or effective diameter) of the aortic valve annulus. Embodiments of the device include a percutaneous or minimally invasive implantable annular or ring-shaped support structure that is deployable and anchorable on the downstream side of the aortic valve. Some embodiments of the device are clamped to the native leaflets of the aortic valve at or near the commissures, thereby reducing the effective diameter of the annulus. Some embodiments of the device are fixed in an over-expanded state and reduce the actual diameter of the aortic valve when the device rebounds toward its default size.

[0011] Representative embodiments of methods, systems, and devices for replacing a defective native heart valve with an artificial heart valve are also disclosed below. Embodiments of the disclosed methods, systems, and devices can be used, for example, to replace an aortic valve with aortic insufficiency or a mitral valve with mitral insufficiency. However, these embodiments are not limiting, as the disclosed methods, systems, and devices can be more generally applied to replace any heart valve.

[0012] In another representative embodiment, a support frame configured to be implanted within a heart valve includes an annular body formed by a plurality of angular struts, the body including a plurality of peaks formed by the intersection of corresponding adjacent struts. The support frame also includes one or more leaflet engagement mechanisms located below the corresponding peaks of the support frame. Each of the one or more leaflet engagement mechanisms defines a leaflet receiving space between two opposing surfaces for an engagement portion of an adjacent leaflet therebetween, wherein the leaflet receiving space can be adjustable to facilitate placement of a portion of an adjacent leaflet within the leaflet engagement mechanism. The support frame can be radially expandable and collapsible.

[0013] In certain embodiments, one or more leaflet engagement mechanisms can include one or more pairs of leaflet clamping arms positioned below a corresponding peak of a support frame, wherein each clamping arm includes a fixed end portion and a free end portion, the free end portion of each pair being configured to engage portions of adjacent leaflets therebetween. In some embodiments, the fixed end portion of each leaflet clamping arm is connected to a corresponding strut at a position below the corresponding peak, and the leaflet clamping arm extends from the fixed end portion to the free end portion in a direction toward the peak. In other embodiments, the fixed end portion of each leaflet clamping arm is connected to a corresponding strut at a position below the corresponding peak, and the leaflet clamping arm extends from the fixed end portion to the free end portion in a direction away from the peak.

[0014] In some embodiments, the free end portions of each pair of leaflet clamping arms can be bent or flexed away from each other.

[0015] In some embodiments, the one or more leaflet engagement mechanisms are movable between an open position and a closed position. In some embodiments, the support frame is configured such that the one or more leaflet engagement mechanisms are in the open position when the support frame is partially deployed from the delivery catheter. In some embodiments, the support frame is configured such that the one or more leaflet engagement mechanisms move to the closed position when the support frame is fully deployed from the delivery catheter.

[0016] In some embodiments, the support frame further comprises one or more leaflet engagement subunits.

[0017] In some embodiments, the one or more leaflet engagement mechanisms are configured to be positioned over one or more commissures formed by the leaflets of the heart valve. In some embodiments, the one or more leaflet engagement mechanisms include three leaflet engagement mechanisms configured to engage the commissures of the aortic valve.

[0018] In some embodiments, the support frame further comprises one or more retention arms coupled to the one or more peaks, the one or more retention arms being configured to engage a delivery device.

[0019] In some embodiments, the support frame is configured to reduce the orifice area of ​​the heart valve after implantation.

[0020] In another representative embodiment, a method for treating valvular insufficiency includes inserting a delivery catheter into the vasculature of the heart adjacent to a heart valve, the delivery catheter delivering a support frame in a radially collapsed state. The method can also include positioning the delivery catheter so that one or more leaflet engagement mechanisms of the support frame are aligned with the commissures of the heart valve. Each of the one or more leaflet engagement mechanisms is located below a corresponding tip of the support frame and defines a leaflet receiving space between two opposing surfaces, wherein the leaflet receiving space is adjustable. The method also includes at least partially deploying the support frame from the delivery catheter to allow the support frame to radially expand to an at least partially deployed state, and engaging one or more of the commissures of the heart valve with the one or more leaflet engagement mechanisms.

[0021] In some embodiments, the act of at least partially deploying the support frame causes one or more leaflet engagement mechanisms to move to an open position to increase the leaflet receiving space.

[0022] In some embodiments, the method further comprises fully deploying the support frame from the delivery catheter such that the one or more leaflet engagement mechanisms move from an open position to a closed position.

[0023] In some embodiments, engaging one or more of the commissures of the heart valve with one or more leaflet engagement mechanisms is effective to reduce the orifice area of ​​the heart valve.

[0024] In some embodiments, the method further comprises releasing the support frame from the delivery catheter and allowing the leaflets to regulate blood flow through the heart valve.

[0025] In some embodiments, the method further includes, after releasing the support frame from the delivery catheter and allowing the leaflets to regulate blood flow through the heart valve, deploying the prosthetic heart valve within the leaflets such that the leaflets are captured between the support frame and the prosthetic heart valve.

[0026] In some embodiments, the act of coapting includes actuating one or more leaflet coaptation mechanisms from an open position to a closed position such that the leaflet coaptation mechanisms engage commissures of the heart valve.

[0027] In another representative embodiment, a support frame configured for implantation within a heart valve includes an annular body formed by a plurality of angular struts, the body including a plurality of peaks formed by the intersection of corresponding adjacent struts. In lieu of or in addition to one or more leaflet engagement mechanisms, the support frame can have one or more frame retention mechanisms configured to limit movement of the support frame within the heart by engaging one or more portions of the aortic root and / or the aorta. The support frame can be radially expandable and collapsible.

[0028] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a perspective view of an exemplary embodiment of a support structure according to the disclosed technology.

[0030] Figure 2 is a cross-sectional view of the native aortic valve, where Figure 1 The supporting structure is placed in it.

[0031] Figure 3 and Figure 4 is used for Figure 1 A perspective view of an exemplary delivery system of a support structure. Specifically, Figure 3 shows the delivery system prior to deployment of the support structure, and Figure 4 The delivery system is shown after deployment of the support structure.

[0032] Figure 5 yes Figure 3 and Figure 4 An exploded view of the components of an exemplary delivery system is shown.

[0033] Figure 6 is shown for releasably connecting a support structure to Figure 3 and Figure 4 An enlarged perspective view of the mechanism of an exemplary delivery system.

[0034] Figure 7 and Figure 8 is a cross-sectional view of a patient's heart showing Figure 3 and Figure 4 How can the conveying system of Figure 1 The support structure is deployed to a desired position on the patient's aortic valve.

[0035] Figures 9 to 13 is a cross-sectional view of a patient's heart showing how Figure 1 The support structure is capable of deploying an exemplary transcatheter heart valve ("THV") to the patient's aortic valve and frictionally securing it to the native leaflets.

[0036] Fig.14 is a perspective view of another exemplary embodiment of a support structure according to the disclosed technology.

[0037] Fig.15 yes Fig.14 A top view of an embodiment of a support structure is shown.

[0038] Fig.16 yes Fig.14A side view of an embodiment of a support structure is shown.

[0039] Fig.17 is a cross-sectional view of a patient's heart illustrating how the delivery system can operate to deliver Fig.14 The support structure is deployed to the desired position on the patient's aortic valve.

[0040] Fig.18 is a cross-sectional view of a patient's heart illustrating how an exemplary THV can be deployed through the aortic arch and into the patient's aortic valve, where the THV can be used Fig.14 The support structure is frictionally fixed to the autologous leaflet.

[0041] Fig.19 is a cross-sectional view of a patient's heart showing a medical device according to another embodiment of the present invention including a stent supporting a deflector for treating a vascular aneurysm.

[0042] Fig. 20 yes Fig.19 A plan view of a portion of a scaffold of a support.

[0043] Fig.21 is a cross-sectional view of a patient's heart illustrating another embodiment of a medical device in which a stent is covered by a deflector and is tapered.

[0044] Fig. 22 is a cross-sectional view of a patient's heart illustrating another embodiment of a medical device in which a stent is covered by a balloon configured to fill an aneurysm within an inadequate blood vessel.

[0045] Fig.23 is a cross-sectional view of another embodiment of a medical device in which a stent is covered by a foam sleeve deflector.

[0046] Fig.24 is a cross-sectional view of a patient's heart illustrating a medical device including another embodiment of a deflector having a ring shape.

[0047] Fig.25 is a cross-sectional view of a patient's heart illustrating a medical device including another embodiment of a pair of annular-shaped deflectors.

[0048] Fig.26 is a cross-sectional view of a patient's heart illustrating a medical device including another embodiment of a deflector with a seal that allows passage of a THV delivery device.

[0049] Fig. 27is a cross-sectional view of a patient's heart illustrating a medical device including another embodiment of a deflector with a resilient hourglass shape configured to resiliently assist in pumping blood.

[0050] Fig.28 is a cross-sectional view of a patient's heart illustrating another embodiment of a medical device including an anchor on a foam deflector supported by a stent.

[0051] Fig.29 is a perspective view of another embodiment of a support frame.

[0052] Fig.30 It is implanted in the native heart valve Fig.29 A cross-sectional perspective view of the support frame.

[0053] Fig.31 It is implanted in a partial cross-section of the aorta. Fig.29 Cross-section of the support frame.

[0054] Fig.32 It is implanted in a partial cross-section of the aorta. Fig.29 Another cross-sectional view of the support frame.

[0055] Fig.33 is a perspective view of another embodiment of a support frame including one or more pairs of leaflet engagement members.

[0056] Fig.34 It is implanted in a partial cross-section of the aorta. Fig.33 Perspective view of the supporting frame.

[0057] Fig.35 yes Fig.33 A partial side elevation view of another embodiment of a support frame in which the free end of the leaflet engagement member is bulbous.

[0058] Fig.36 yes Fig.33 Partial side elevation view of another embodiment of a support frame in which the free end portions of the leaflet engagement members are curved.

[0059] Fig.37 yes Fig.36 Partial side elevation view of a support frame showing the autologous leaflets engaged between leaflet engagement members.

[0060] Fig.38 Has a single leaflet coaptation member Fig.33 A partial side elevation view of another embodiment of a support frame.

[0061] Fig.39 A leaflet engagement member extending from a distal tip of a support frame Fig.33 A partial side elevation view of another embodiment of a support frame.

[0062] Fig.40 is a side elevation view of another embodiment of a support frame in a flattened state including multiple pairs of leaflet engagement members having curved sections.

[0063] Fig.41 is a side elevation view of another embodiment of a support frame in a flattened state including multiple pairs of semi-annular leaflet engagement members.

[0064] Fig.42 It is implanted in the aortic root Fig.41 Plan view of the supporting frame.

[0065] Fig.43 is a partial side elevation view of another embodiment of a support frame including a plurality of clamping members.

[0066] Fig.44 yes Fig.43 Side elevation view of the clamping arm of the support frame.

[0067] Fig.45 yes Fig.43 A partial side elevation view of a clamping member of a support frame showing the clamping member engaging leaflets of a native valve.

[0068] Fig.46 yes Fig.43 A side elevation view of a portion of a clamping member illustrating the forces applied to the clamping member.

[0069] Fig.47 is a partial side elevation view of another embodiment of a support frame including one or more commissure clips.

[0070] Fig.48 is a partial side elevation view of another embodiment of a support frame including one or more pairs of curved leaflet engagement members.

[0071] Fig.49 A method of forming a leaflet engaging member that includes one or more pairs of leaflet engaging members defining a gap therebetween. Fig.48 A partial side elevation view of another embodiment of a support frame.

[0072] Fig.50 is a partial side elevation view of another embodiment of a support frame including a plurality of curved struts defining leaflet coaptation regions therebetween.

[0073] Fig.51 yes Fig.50 A partial side elevation view of another embodiment of a support frame wherein the curved struts include serrations.

[0074] Fig.52 is a partial side elevation view of another embodiment of a support frame including a plurality of struts defining a selected subapical leaflet capture region.

[0075] Fig.53 is a side elevation view of another embodiment of a support frame in a flattened state including multiple pairs of spring members.

[0076] Fig.54 yes Fig.53 Partial side elevation view of the support frame.

[0077] Fig.55 With native valve leaflets articulated between spring members Fig.53 Partial side elevation view of the support frame.

[0078] Fig.56 is a spring member configured to overlap each other Fig.53 A partial side elevation view of an alternative embodiment of a support frame.

[0079] Fig.57 A spring member is included Fig.53 A partial side elevation view of another embodiment of a support frame, the spring member having serrations orthogonal to a surface of the spring member.

[0080] Fig.58 A spring member is included Fig.53 A partial side elevation view of another embodiment of a support frame of the invention, the spring member having serrations oriented in the direction of the outflow end of the support frame.

[0081] Fig.59A yes Fig.53 A partial side elevation view of another embodiment of a support frame of FIG. 1 wherein one spring member of each pair of spring members has a circular protrusion and one spring member has a circular cutout.

[0082] Fig.59B yes Fig.59A A partial side elevation view of a support frame showing a circular protrusion of one corresponding spring member received within a circular cutout of another corresponding spring member.

[0083] Fig.60 is a partial side elevation view of another embodiment of a support frame including a leaflet engagement portion.

[0084] Fig.61 yes Fig.60 A partial side elevation view of another embodiment of a support frame wherein the leaflet engagement portion includes two gaps defined by a difference in thickness of struts.

[0085] Fig.62yes Fig.61 Partial side elevation view of another embodiment of a support frame wherein the leaflet engagement portion comprises barbs.

[0086] Fig.63 yes Fig.61 A partial side elevation view of another embodiment of a support frame wherein the gap of the leaflet engagement portion comprises a tapered shape and one or more barbs.

[0087] Fig.64 Including sawtooth Fig.60 A partial side elevation view of another embodiment of a support frame.

[0088] Fig.65 It includes a pair of leaflet engagement wheels Fig.60 A partial side elevation view of another embodiment of a support frame.

[0089] Fig.66A is a partial side elevation view of another embodiment of a support frame including a leaflet clamping mechanism configured as a pair of clamping arms.

[0090] Fig.66B yes Fig.66A Partial side elevation view of a support frame showing the leaflet clamping mechanism in a closed position.

[0091] Fig.66C yes Fig.66A A partial side elevation view of a support frame showing the leaflet clamping mechanism being held in an open position by the delivery device.

[0092] Fig.66D yes Fig.66A A partial side elevation view of a support frame showing a leaflet clamping mechanism engaging a pair of native valve leaflets.

[0093] Fig.67A is a partial side elevation view of another embodiment of a support frame including an elongated member configured as a leaflet engagement mechanism.

[0094] Fig.67B yes Fig.67A Partial side elevation view of a support frame showing the leaflet engagement mechanism in a closed position.

[0095] Fig.68A yes Fig.67A A perspective view of a support frame showing the leaflet engagement mechanism being held in an open position by the delivery device.

[0096] Fig.68B yes Fig.67A A perspective view of a support frame showing the leaflet engagement mechanism engaging the native valve leaflets.

[0097] Fig.69A is a partial side elevation view of another embodiment of a support frame including a leaflet engagement mechanism configured as a pair of leaflet engagement members.

[0098] Fig.69B yes Fig.69A Partial side elevation view of a support frame showing the leaflet engagement mechanism in an open position.

[0099] Fig.70A is a perspective view of another embodiment of a support frame including a leaflet engagement mechanism configured as a plurality of pairs of leaflet engagement members.

[0100] Fig.70B yes Fig.70A A perspective view of a support frame of FIG. 1 showing the leaflet engagement mechanism in an open position when the support frame is partially deployed from a delivery device.

[0101] Fig.71 is a side elevation view of another embodiment of a support frame including a plurality of branch members defining a leaflet engagement mechanism.

[0102] Fig.72A is deployed from a delivery device portion with the leaflet engagement mechanism in an open position Fig.71 Perspective view of the supporting frame.

[0103] Fig.72B is deployed from a delivery device portion with the leaflet engagement mechanism in a closed position Fig.71 Perspective view of the supporting frame.

[0104] Fig.73 It is implanted in the aortic valve Fig.71 Plan view of the supporting frame.

[0105] Fig.74A is a side elevation view of another embodiment of a support frame in a flattened state comprising a plurality of subunits defining leaflet engagement mechanisms.

[0106] Fig.74B In the fully expanded configuration Fig.74A Side elevation view of the support frame.

[0107] Fig.75A is a side elevation view of another embodiment of a support frame in a flattened state and comprising a plurality of subunits defining leaflet engagement mechanisms.

[0108] Fig.75B In the fully expanded configuration Fig.75A Side elevation view of the support frame.

[0109] Fig.76A is a side elevation view of another embodiment of a support frame in a flattened state and comprising a plurality of subunits defining leaflet engagement mechanisms.

[0110] Fig.76B In a flat state Fig.76A Side elevation view of a support frame showing the leaflet engagement mechanism in an open position.

[0111] Fig.77A is a partial perspective view of another embodiment of a support frame including one or more leaflet engagement mechanisms comprising multiple pairs of struts.

[0112] Fig.77B yes Fig.77A Perspective view of the supporting frame.

[0113] Fig.77C Located in the native heart valve Fig.77A A plan view of an alternative embodiment of a support frame.

[0114] Fig.78 is a perspective view of another embodiment of a support frame including a leaflet clamping mechanism configured as clamping arms located on an interior of the support frame.

[0115] Fig.79 is a perspective view of another embodiment of a support frame including a leaflet clamping mechanism configured as clamping arms located on an exterior of the support frame.

[0116] Fig.80 is a side elevation view of the clamping arm.

[0117] Fig.81 is a side elevation view of a portion of an actuation assembly of a conveying device.

[0118] Fig.82A yes Fig.78 A perspective view of a support frame showing a portion of an actuator assembly engaged with a clamping mechanism and showing the actuator assembly conduit in a retracted position.

[0119] Fig.82B yes Fig.78 A perspective view of a support frame showing a portion of an actuator assembly engaged with a clamping mechanism and showing the actuator assembly guide in an advanced position.

[0120] Fig.83 is shown coupled to the conveying device Fig.78 Perspective view of the supporting frame.

[0121] Fig.84 is a side elevation view of a portion of an alternative embodiment of an actuator member.

[0122] Fig.85 is a side elevation view of a portion of another alternative embodiment of an actuator member.

[0123] Fig.86 is used for Fig.85 The actuator member is used together with Fig.78 A perspective view of another embodiment of a support frame.

[0124] Fig.87 is used for Fig.78 A side elevation view of an embodiment of a conveying apparatus for use with a support frame.

[0125] Fig.88 It is connected with the conveying equipment Fig.78 A perspective view of a support frame of FIG. 1 and showing the clamping members in a closed position.

[0126] Fig.89A is used for Fig.78 A perspective view of another embodiment of an outer sheath of a delivery device for use with a support frame.

[0127] Fig.89B yes Fig.89A Perspective view of the inner sheath of the delivery device.

[0128] Fig.90 is a perspective view of another embodiment of a support frame.

[0129] Fig.91 is a cross-sectional side elevation view of another embodiment of a support frame including one or more arch members implanted within the aortic root.

[0130] Fig.92 is shown in cross section of the aorta. Fig.91 Plan view of the supporting frame.

[0131] Fig.93 is a cross-sectional side elevation view of another embodiment of a support frame including one or more vertical and horizontal members extending into the ascending aorta.

[0132] Fig.94 A horizontal member that extends around two adjacent vertical members. Fig.93 A cross-sectional side elevation view of an alternative embodiment of a support frame.

[0133] Fig.95 Has a single vertical member Fig.93 A cross-sectional side elevation view of another alternative embodiment of a support frame.

[0134] Fig.96A horizontal member that is centered about its own vertical member but does not extend around adjacent vertical members. Fig.93 A cross-sectional side elevation view of another alternative embodiment of a support frame.

[0135] Fig.97 is a cross-sectional side elevation view of another embodiment of a support frame implanted within the aortic root and including an annular member located at the sinotubular junction.

[0136] Fig.98 is a cross-sectional side elevation view of another embodiment of a support frame implanted within the aortic root and comprising a plurality of struts configured to conform to the contour of the aortic sinuses.

[0137] Fig.99A is a perspective view of another embodiment of a support frame including a plurality of distally extending arcuate members.

[0138] Fig.99B yes Fig.99A Plan view of the supporting frame.

[0139] Fig.100 It is implanted in the aortic root Fig.99A Cross-sectional side elevation view of a support frame.

[0140] Fig.101 is a cross-sectional side elevation view of another embodiment of a support frame including a plurality of retaining arms configured to apply pressure to the sinotubular junction and the walls of the aortic sinuses.

[0141] Fig.102 is a cross-sectional side elevation view of another embodiment of a support frame positioned within the aortic root and including a spring member extending into the ascending aorta.

[0142] Fig.103 yes Fig.102 A cross-sectional side elevation view of a support frame showing a spring member connected to the distal end of a delivery device.

[0143] Fig.104 is a cross-sectional side elevation view of another embodiment of a support frame positioned within an aorta and comprising a first frame and a second frame interconnected by one or more elongated members.

[0144] Fig.105 is a cross-sectional side elevation view of another embodiment of a support frame positioned within an aorta and comprising a first frame and a second frame interconnected by a spring member.

[0145] Fig.106 is a perspective view of another embodiment of a support frame including a first frame and a second frame connected to each other by a plurality of interconnecting members.

[0146] Fig.107 yes Fig.106 Plan view of the supporting frame.

[0147] Fig.108 yes Fig.106 Side elevation view of the support frame.

[0148] Fig.109 is a perspective view of another embodiment of a support frame including a semi-annular member supported by a vertical member shape configured such that the diameter of the semi-annular member is greater than the diameter of the ascending aorta.

[0149] Fig.110 It is located within the cross section of the aortic root. Fig.109 Side elevation view of the support frame.

[0150] Fig.111 It includes a semi-circular member Fig.109 A perspective view of an alternative embodiment of a support frame, wherein the semi-annular member is shaped to have a diameter larger than the diameter of the ascending aorta so that the vertical members supporting the semi-annular member remain upright in an unconstrained configuration.

[0151] Fig.112 It is located within the cross section of the aortic root. Fig.111 Side elevation view of the support frame.

[0152] Fig.113 is a perspective view of another embodiment of another embodiment of a support frame including a plurality of retaining rings.

[0153] Fig.114 It is shown Fig.113 Side elevation view of the support frame loaded onto the conveyor equipment.

[0154] Fig.115 It shows the loaded Fig.113 Partial cross-sectional view of a support frame of a conveying device.

[0155] Fig.116 is used for Fig.113 A graph of stress versus strain of a support frame illustrating stress exerted on a delivery device by the support frame on a transcatheter heart valve curled beneath the support frame as the support frame and the transcatheter heart valve expand from a radially collapsed state to a radially expanded state.

[0156] Fig.117 Located in the aortic root Fig.113 Cross-sectional side elevation view of a support frame.

[0157] Fig.118It is located within the cross section of the aortic root. Fig.113 Plan view of the supporting frame.

[0158] Fig.119 It is located in the aortic root and is expanded by a balloon catheter. Fig.113 Cross-sectional side elevation view of a support frame.

[0159] Fig.120 It is located in the aortic root and surrounds the transcatheter heart valve. Fig.113 Cross-sectional side elevation view of a support frame.

[0160] Fig.121 It is composed of multiple planar components. Fig.113 A perspective view of another embodiment of a support frame.

[0161] Fig.122 is a perspective view of another embodiment of a support frame including multiple leaflet engagement mechanisms and multiple actuator mechanisms.

[0162] Fig.123 yes Fig.122 A side elevation view of a portion of the leaflet engagement mechanism of a support frame.

[0163] Fig.124 is coupled to the conveying device Fig.122 0024] A perspective view of a support frame of the embodiment of the present invention is shown in FIG. 1 and shows the support frame in an open position.

[0164] Fig.125 is coupled to the conveying device Fig.122 0014] A perspective view of a support frame is shown in FIG. 10 and showing the support frame in a closed position.

[0165] Fig.126 It is implanted in the cross section of the aortic root. Fig.122 Perspective view of the supporting frame.

[0166] Fig.127 is a perspective view of another embodiment of a support frame including inner and outer trefoil members configured to clamp leaflets of a native valve therebetween.

[0167] Fig.128 It is launched from the conveying equipment part Fig.127 Side elevation view of the support frame.

[0168] Fig.129 is partially developed from an alternative embodiment of a delivery device including a balloon Fig.127 Side elevation view of the support frame.

[0169] Fig.130 is coupled to the conveying device Fig.130Perspective view of the supporting frame. DETAILED DESCRIPTION

[0170] General considerations

[0171] Disclosed below are representative embodiments of support structures (sometimes referred to as "support stents," "support frames," "support bands," or "support rings") that can be used to secure an artificial heart valve within a native heart valve or to reduce the orifice area of ​​a native heart valve. For illustrative purposes, embodiments of the support structures are described as being used to secure a transcatheter heart valve ("THV") in the aortic valve or mitral valve of a heart. It should be understood that the disclosed support structures and THVs can be configured to be used with any other heart valve as well. Also disclosed herein are exemplary methods and systems for deploying support structures and corresponding THVs. Although primarily described with respect to exemplary methods and systems for replacing an aortic valve or mitral valve, it should be understood that the disclosed methods and systems can be adapted to deliver support structures and THVs to any heart valve. In addition, as used herein, the term "coupled" encompasses mechanical methods and other practical methods of coupling or linking items together, and does not exclude the presence of intermediate elements between coupled items.

[0172] For illustrative purposes, certain embodiments of the support structure are described for use in conjunction with embodiments of balloon-expandable THVs described in U.S. Patent Application Publication Nos. 2007 / 0112422 (U.S. Application Serial No. 11 / 280,063) and 2010 / 0049313 (U.S. Application Serial No. 12 / 429,040), which are expressly incorporated herein by reference. However, it should be understood that this particular use is for illustrative purposes only and should not be construed as limiting. On the contrary, embodiments of the disclosed support structure can be used to secure a wide variety of THVs delivered by various mechanisms (e.g., self-expanding heart valves, other balloon-expandable heart valves, etc.). For example, any of the embodiments described in U.S. Patent No. 6,730,118 can be used with embodiments of the disclosed support structure. U.S. Patent No. 6,730,118 is expressly incorporated herein by reference.

[0173] The specification and claims sometimes refer to a first catheter being "advanced" relative to a second catheter. It should be noted that this language covers not only situations where the first catheter is physically moved relative to the second catheter by an operator, but also situations where the second catheter is physically moved relative to the first catheter by an operator (e.g., the second catheter is withdrawn over the first catheter, causing the first catheter to be advanced relative to the second catheter). Similarly, the specification and claims sometimes refer to a first catheter being "withdrawn" relative to the second catheter. It should be noted that this language covers not only situations where the first catheter is physically moved relative to the second catheter by an operator, but also situations where the second catheter is physically moved relative to the first catheter by an operator (e.g., the second catheter is advanced over the first catheter, causing the first catheter to be withdrawn relative to the second catheter).

[0174] The methods, systems, and devices should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, either alone or in various combinations or sub-combinations with one another. The disclosed methods, systems, and devices are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and devices require that any one or more specific advantages be presented or problems be solved.

[0175] Although some disclosed method operations are described in a particular, sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless specific language set forth below requires a particular order. For example, operations described in sequence may in some cases be rearranged or performed simultaneously. In addition, for simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods, systems, and apparatuses can be used in conjunction with other systems, methods, and apparatuses.

[0176] Repair of aortic valve insufficiency

[0177] Embodiments of the support structures, stents, or frames disclosed herein are suitable for repairing aortic insufficiency or aortic regurgitation, in which the native aortic valve leaflets are no longer properly or completely closed, allowing blood to leak or regurgitate through the aortic valve during diastole. Some of the support structures described below can repair or improve aortic insufficiency by reducing the diameter (actual diameter or effective diameter) of the aortic valve annulus. Some embodiments of the support structure clamp the native aortic valve leaflets at or near the commissures together, thereby reducing the effective diameter of the annulus. Some embodiments pull the annulus of the valve radially inward, thereby reducing the diameter of the annulus by radially overexpanding the support structure, engaging the support structure with one or more structures of the aortic valve (e.g., native leaflets and / or annulus) and allowing the support structure to contract radially to a default size to reduce the actual diameter. Some embodiments have both.

[0178] In some cases, the support structure will itself repair or itself improve aortic insufficiency.If the function of the valve deteriorates, for example over the course of months or years, the support structure is used as a dock for it to deploy the THV, as described in detail below.

[0179] Exemplary Embodiments for Replacing an Aortic Valve

[0180] Figure 1 1 is a perspective view showing an exemplary embodiment of a support bracket or frame 10. The support bracket 10 has a generally annular or ring-shaped body formed of a suitable shape memory metal or alloy, such as spring steel, cobalt chromium alloy, or a combination thereof. Or nitinol. Desirably, the material of the stent 10 allows the stent to automatically expand to its functional size and shape when deployed, and allows the stent to radially compress to a smaller profile for delivery through the patient's vasculature. However, in other embodiments, the stent does not expand on its own. In these embodiments, and as described more fully below, other mechanisms (e.g., a balloon catheter) can be used to expand the stent.

[0181] In the illustrated embodiment, the projection of the support bracket 10 onto the xy plane has a generally annular or ring-like shape. The illustrated support bracket 10 further defines some peaks and valleys (or wave crests and valleys) along its circumference. For example, the support bracket 10 forms a sinusoidal shape in the z direction. In other embodiments, the support bracket 10 is formed into a different shape in the z direction (e.g., sharp teeth, small rings, square waves, or otherwise shaped to include peaks and valleys).

[0182] The support bracket 10 shown includes three peaks 20, 22, 24 and three valleys 30, 32, 34. In the illustrated embodiment, the peaks 20, 22, 24 are disposed above the valleys 30, 32, 34 in the z-direction. In some embodiments, the radius of the peaks is greater than the radius of the valleys 30, 32, 34, or vice versa. For example, in some embodiments, the projection of the support bracket 10 onto the xy plane forms a closed shape (e.g., a starfish shape) with a variable diameter.

[0183] The size of the support stent 10 can vary depending on the implementation. In a specific embodiment, the support stent 10 is designed to be sized so that the support stent can be placed in the patient's aorta at a position adjacent to the aortic valve, thereby surrounding the aortic valve. In addition, in order to frictionally fix the artificial heart valve inside the artificial heart valve, the diameter of certain embodiments of the support stent 10 is equal to or less than the diameter of the artificial heart valve when it is fully expanded. In a specific embodiment, for example, the support stent can have an inner diameter or outer diameter between 10mm and 50mm (e.g., between 17mm and 28mm) and have a height between 5mm and 35mm (e.g., between 8mm and 18mm). In addition, the thickness of the annular body of the support stent 10 can vary depending on the embodiment, but in some embodiments, the thickness is between 0.3mm and 1.2mm.

[0184] Figure 2 1 is a perspective view of an exemplary support stent 10 placed on the surface of the outflow side of the native aortic valve and also shows the shape of the support stent. Figure 2 It can be seen that the valleys 30, 32, 34 of the support stent 10 are shaped so that they can be placed adjacent to the commissures 50, 52, 54 of the native leaflets 60, 62, 64 of the aortic valve. In addition, in the illustrated embodiment, when the aortic valve is fully open, the peaks 20, 22, 24 are shaped so that they are generally similar to or smaller than the size and shape of the leaflets 60, 62, 64, but slightly smaller than and below the height of the leaflets at the tips of the leaflets 60, 62, 64. In other embodiments, the peaks 20, 22, 24 are oriented so that they are adjacent to the commissures 50, 52, 54 of the native leaflets 60, 62, 64 and the valleys 30, 32, 34 are opposite the tips of the leaflets 60, 62, 64. The support stent 10 can be equally placed within the aortic valve in any other orientation.

[0185] It should be understood that the shape of the support stent or frame 10 can vary depending on the implementation. For example, in some embodiments, the support stent is not sinusoidal or is otherwise shaped in the z-plane. In other embodiments, the support stent is shaped as a cylindrical band or sleeve. In general, the support stent or frame can be of any shape that defines an interior through which the THV can be inserted, thereby causing the native leaflets of the aortic valve (or other heart valve) to be clamped or fixedly held between the support stent and the THV. In addition, the support stent can have a more complex structure. For example, although Figure 1 and Figure 2 While the support stent shown is formed from a single annular member (or strut), the support stent can include multiple annular elements that are interlocked or otherwise interconnected (eg, via longitudinal members).

[0186] Return to Figure 1, the support stent 10 shown also includes retaining arms 21, 23, 25, which can be used to help place and deploy the support stent 10 to its proper position relative to the native aortic valve. The retaining arms 21, 23, 25 can have corresponding holes 26, 27, 28. An exemplary deployment system and procedure for deploying the support stent 10 using the retaining arms 21, 23, 25 are described in more detail below. The support stent 10 can also have one or more barbs located on its surface. These barbs allow the support stent 10 to be more firmly attached to the tissue surrounding the stent or the leaflets of the aorta.

[0187] Figure 3 and Figure 4 is a side view of a distal portion of an exemplary delivery device 100 for delivering a stent-supporting stent 10 through a patient's vasculature to a location adjacent to a native aortic valve. Figure 3 The delivery device is shown when the support stent 10 is in a compressed, pre-expanded state, and Figure 4 The delivery device is shown when the support stent 10 is in an uncompressed, expanded state. The delivery device 100 includes a guide catheter 102 having an elongated shaft 104, the distal end 105 of which is open in the illustrated embodiment. In other embodiments, the distal end 105 of the guide catheter 102 can taper to a conical shape including multiple "flaps" that form a protective nose cone, which can be pushed open when the support stent 10 and any internal catheters are advanced through the protective nose cone. In addition, for illustrative purposes, the guide catheter 102 is shown partially cut away, thereby exposing the catheter inside it.

[0188] The proximal end (not shown) of the guide catheter 102 is connected to a handle of the delivery device 100. The handle can be used by a clinician to advance and retract the delivery device through the patient's vasculature during delivery of the stent. In a particular use, after the delivery device 100 has been inserted percutaneously through the femoral artery, it is advanced in a retrograde direction through the aortic arch of the patient's heart. The guide catheter can be configured to be selectively steerable or bendable to facilitate advancement of the delivery system 100 through the patient's vasculature. An exemplary steerable guide catheter as can be used in embodiments of the disclosed technology is described in detail in U.S. Patent Application Publication No. 2007 / 0005131 (U.S. Patent Application Serial No. 11 / 152,288), which is expressly incorporated herein by reference.

[0189] The delivery device 100 also includes a stent delivery catheter 108 disposed within the interior of the guide catheter 102. The stent delivery catheter 108 has an elongated shaft 110 and an outer fork 140 connected to a distal portion of the shaft 110. The shaft 110 of the stent delivery catheter 108 can be configured to be axially movable relative to the shaft 104 of the guide catheter 102. In addition, the shaft 110 of the stent delivery catheter 108 can be sized so that its outer wall is adjacent to or in contact with the inner wall of the shaft 104 of the guide catheter 102.

[0190] The delivery device 100 can also include an inner catheter 118 disposed in the interior of the stent delivery catheter 108. The inner catheter 118 can have an elongated shaft 120 and an inner fork 138 fixed to the distal portion of the shaft 120. The shaft 120 of the inner catheter 118 can be configured to be axially movable relative to the shaft 104 of the guide catheter 102 and relative to the shaft 110 of the stent delivery catheter 108. In addition, the shaft 120 of the inner catheter 118 can be designed and sized so that its outer wall is adjacent to or in contact with the inner wall of the shaft 110 of the stent delivery catheter 108. A guide wire (not shown) can be inserted into the interior of the inner catheter 118. The guide wire can be used, for example, to help ensure that the guide catheter 102 and its inner catheter are properly advanced through the patient's vascular system.

[0191] like Figure 5 As best shown, the stent retention mechanism is formed by an inner fork 138 attached to the distal portion of the shaft 120 of the inner catheter 118 and an outer fork 140 attached to the distal portion of the shaft 110 of the stent delivery catheter 108. The inner fork 138 includes a plurality of flexible inner prongs 141, 142, 143 (three in the illustrated embodiment) at its distal end corresponding to the retaining arms 21, 23, 25 supporting the stent 10 and a head portion 144 at its proximal end. The outer fork 140 includes a plurality of flexible outer prongs 145, 146, 147 (three in the illustrated embodiment) at its distal end corresponding to the retaining arms 21, 23 of the stent 10 and a head portion 148 at its proximal end. The distal portions of the outer prongs 145, 146, 147 are formed with corresponding holes 155, 156, 157 that are sized to receive the retaining arms 21, 23, 25.

[0192] Figure 61 is an enlarged view of one of the retaining arms 21, 23, 25 when it is docked with the corresponding prongs of the outer fork 140 and the inner fork 138. In this example, the retaining arm 21 is shown, although it should be understood that the retaining mechanism is similarly formed for the retaining arms 23, 25. The distal portion of the outer fork 145 is formed with a hole 155. When assembled, the retaining arm 21 of the stent is inserted through the hole 155 of the prong 145 of the outer fork, and the prong 141 of the inner fork is inserted through the hole 26 of the retaining arm 21 so that the retaining arm 21 is retained in the hole 155.

[0193] Proximally (in the direction of arrow 152) retracting inner prong 142 to remove the prongs from aperture 26 allows retention arm 21 to be removed from aperture 155, thereby effectively releasing the retention arm from the retention mechanism. For example, outer prong 45 and retention arm 21 can be formed so that when inner prong 141 is withdrawn from aperture 26, outer prong 145 flexes radially inwardly ( Figure 7 downward) and / or the retaining arm 21 of the support bracket is bent radially outward ( Figure 7 140), thereby causing the retaining arm 21 to be removed from the hole 155. In this way, the retaining mechanism formed by the inner fork 138 and the outer fork 140 creates a releasable connection with the support stent 10 that is strong enough to hold the support stent to the stent delivery catheter 108 and allow the user to adjust the position of the support stent after the support stent is deployed. When the support stent 10 is positioned at a desired position adjacent to the leaflet of the aortic valve, the connection between the support stent and the retaining mechanism can be released by retracting the inner fork 138 relative to the outer fork 140, as further described below. In other embodiments, the functions of the inner fork and the outer fork can be reversed. For example, the forks of the inner fork are formed with holes that are sized to receive corresponding retaining arms of the support stent, and when the retaining arms are placed through the holes of the forks of the inner fork, the forks of the outer fork can be inserted through the holes of the retaining arms.

[0194] like Figure 5, the head portion 144 of the inner fork can be connected to the distal portion of the shaft 120 of the inner catheter 118. In the illustrated embodiment, for example, the head portion 144 of the inner fork is formed with a plurality of angularly spaced, inwardly offset retaining flanges 154. The end piece of the shaft 120 can be formed as a cylindrical shaft having an annular groove 121. On the distal side of the annular groove 121, the shaft 120 can have a collar 122 having an outer diameter slightly larger than the diameter defined by the inner free ends of the flanges 154. Thus, the inner fork 138 can be secured to the end piece by inserting the head portion 144 of the inner fork onto the end piece of the shaft 120 until the flanges 154 are flexed inwardly into the annular groove 121 adjacent the collar 122, thereby forming a snap-fit ​​connection between the head portion 144 and the shaft 120. The head portion 144 can have a proximal end that engages the annular shoulder 123 of the shaft 120 with a slightly larger diameter to prevent the head portion from sliding longitudinally along the shaft 120 in a proximal direction.

[0195] The head portion 148 of the outer fork can be secured to the distal end portion of the shaft 110 of the stent delivery catheter 108 in a similar manner. Figure 5 As shown, the head portion 148 can be formed with a plurality of angularly spaced, inwardly biased retaining flanges 155. The end piece of the shaft 110 can be formed as a cylindrical shaft having an annular groove 111. On the distal side of the annular groove 111, the shaft 110 can have a collar 112, the outer diameter of which is slightly larger than the diameter defined by the free ends of the flanges 155. Thus, the outer fork 140 can be secured to the end piece of the shaft 110 by inserting the shaft 110 onto the head portion 148 until the flanges are flexed inwardly into the grooves 111, thereby forming a snap-fit ​​connection between the head portion 148 and the shaft 110. The head portion 148 can have a proximal end that engages the annular shoulder 123 of the shaft 110, the proximal end being slightly larger so as to prevent the head portion from sliding longitudinally along the shaft 110 in the proximal direction.

[0196] exist Figure 3 , the stent 10 is shown in a radially compressed state within the interior of the elongated shaft 104 of the guide catheter 102. In the radially compressed state, the distance along the z-axis between the peaks and adjacent valleys of the stent is greater than the distance along the z-axis between the peaks and adjacent valleys when the stent is in its uncompressed state. The distal portion of the shaft 104 can also be referred to as the delivery sheath of the stent 10. In this undeployed and compressed state, the outer fork 140 and the inner fork 138 of the stent delivery catheter 108 and the inner catheter 118 are arranged as described above with respect to Figure 5 and Figure 6The manner described engages the retaining arms 21, 23, 25 of the support stent 10. To deploy the support stent 10 (advance the stent from the delivery system) in the illustrated embodiment, the stent delivery catheter 108 and the inner catheter 118 are advanced toward the distal end 105 of the guide catheter 102 using one or more control handles or mechanisms (not shown) located at the proximal end of the guide catheter 102. This action causes the support stent 10 to be advanced outward through the distal end 105 of the guide catheter 102 and expand into its relaxed, uncompressed state (e.g., Figure 1 and Figure 2 shown).

[0197] Figure 4 1 is a perspective view showing the support stent 10 after being advanced from the distal end of the guide catheter 102. Figure 4 As shown, the support stent 10 now assumes its relaxed, uncompressed shape, but is still connected to the outer fork 140 and the inner fork 138 at its retaining arms 21, 23, 25. In this configuration, the support stent 10 can be rotated (in a clockwise or counterclockwise direction) or repositioned (in the proximal and distal directions and / or repositioned to a different position in the xy plane) into a suitable orientation adjacent to its desired target area. For example, the support stent 10 can be rotated (in a clockwise or counterclockwise direction) or repositioned (in a proximal and distal direction and / or repositioned to a different position in the xy plane) into a suitable orientation adjacent to its desired target area. Figure 2 The manner shown is to be placed against the upper surface of the leaflet of the aortic valve, while the support stent 10 is still connected to the delivery system 100 via the retaining arms 21, 23, 25. Figures 7 to 12 As more fully shown in , a prosthetic valve (e.g., a THV) can be delivered to the aortic valve via a transapical approach (e.g., through the apex of the heart and through the left ventricle) and deployed within the native valve so that the prosthetic valve is secured in place by friction engagement between the supporting stent, the native leaflets, and the prosthetic valve.

[0198] In a particular embodiment, the support stent 10 is shaped so that the THV can be placed in the interior of the support stent together with the autologous leaflets of the aortic valve. More specifically, the support stent 10 can be shaped so that the autologous leaflets are gradually enclosed or clamped between the support stent 10 and the outside of the THV when the THV is installed. For example, when fully expanded, the diameter of the support stent 10 can be equal to or less than the maximum diameter of the THV, thereby causing the THV to frictionally fit the leaflets of the aortic valve and the support stent 10. This friction is suitable for creating a solid foundation for the THV that is independent of the state or condition of the leaflets in the aortic valve. For example, the THV is most commonly used to treat aortic stenosis, which is a condition in which the leaflets of the aortic valve are hardened by calcium. The hardened leaflets generally provide a good support structure for anchoring the THV in the aortic valve ring. However, there can be other conditions in which it is desirable to transplant the THV into the aortic valve, and the other conditions do not cause hardening of the leaflets of the aortic valve. For example, when treating a patient with aortic insufficiency, the support stent 10 can be used as a basis for a THV. Aortic insufficiency occurs when the aortic valve annulus expands so that the aortic valve is not tightly closed. Under this condition, the aortic valve annulus is larger than normal and will otherwise require a large THV. However, using a support stent or frame (such as the support stent or frame 10), a smaller THV can be used, making the THV delivery process easier and safer. In addition, the use of the support stent prevents displacement of the THV if there is any further expansion of the aortic valve.

[0199] The support stent can be used to secure a THV in any situation where the aorta or aortic valve is not suitable to help support the THV and is not limited to situations of aortic valve insufficiency. For example, the support stent 10 can be used in situations where the aortic valve annulus is too dilated or the leaflets of the aorta are too weak or too delicate. For example, in situations where the autologous leaflet tissue is too delicate due to excess collagen in the aorta, the support stent can be used to create an anchor for the THV.

[0200] Figures 7 to 13 An exemplary procedure for deploying a support stent and securing a THV to the support stent is shown. Specifically, Figures 7 and 8 is a cross-sectional view through the left side of a patient's heart illustrating the action involved in delivering stent support 10 through the aortic arch to the aortic valve. Figures 9 to 13 1 is a cross-sectional view through the left side of a patient's heart, which shows the behavior of the THV 250 as it is deployed and engages the supporting stent 10. To better illustrate the components of the delivery system 100, the guide catheter 102 is positioned in the Figures 7 to 13250 is shown partially cut away. For the sake of brevity, certain details of the delivery system of THV 250 are omitted. Additional details and alternative embodiments of the delivery system for THV 250 that can be used with the support stent described herein are discussed in U.S. Patent Application Publication No. 2007 / 0112422 (U.S. Application Serial No. 11 / 280,063), which is expressly incorporated herein by reference.

[0201] Figure 7 The guide catheter 102 of the delivery system 100 is shown as it is advanced through the aortic arch 202 into a position near the surface of the outflow side of the aortic valve 210. The delivery system 100 can be inserted through the femoral artery of the patient and advanced into the aorta in a retrograde direction. Figure 7 Also shown are the stent delivery catheter 108, the inner catheter 118, and the supporting stent 10. Figure 7 In the embodiment, the support stent 10 is in a radially compressed, pre-expanded state. Figure 7 Also shown are the outer fork 140 and the inner fork 138, which couple the radially compressed stent 10 to the distal ends of the stent delivery catheter 108 and the inner catheter 118, respectively.

[0202] Figure 8 The support stent 10 is shown after it has been advanced through the distal end of the guide catheter 102 and assumes its final, uncompressed shape in a position above and adjacent the aortic valve 210. The support stent 10 can also be placed directly on the surface of the outflow side of the aortic valve. Figure 8 The stent delivery catheter 108 and the inner catheter 118 are shown to have been advanced through the distal end of the guide catheter 102, thereby pushing the support stent 10 out of the guide catheter and allowing the support stent 10 to expand to its natural shape. In certain embodiments, the support stent 10 is rotated and positioned as necessary so that the support stent generally surrounds the aortic valve and aligns the peak of the support stent with the tip of the native leaflet of the aortic valve 210. Therefore, when the THV is inserted into the aortic valve 210 and expanded within the aortic valve 210, the leaflets of the aortic valve will engage at least most of the surface in the interior of the support stent 10. This alignment will create an overall tighter fit between the support stent 10 and the THV. In other embodiments, the support stent 10 is rotated and positioned as necessary so that the peak of the support stent 10 is aligned with the commissure or other portion of the aortic valve. The position of the guide catheter 102 and support stent 10 relative to the aortic valve 210, as well as the position of other components of the system can be monitored using radiopaque markers and fluoroscopy, or using other imaging systems, such as transesophageal echo, transthoracic echo, intravascular ultrasound ("IVUS"), or radiopaque injectable dye monitoring.

[0203] Figure 8Also shown are the prongs of the outer fork 140 and the prongs of the inner fork 138. In an exemplary procedure, the outer fork 140 and the prongs of the inner fork 138 remain fixed to the support stent 10 until the THV is deployed and frictionally engaged to the support stent. The inner and outer forks desirably form a connection between the stent 10 and the delivery system that is sufficiently strong and rigid to allow the surgeon to hold the stent 10 in a desired implanted position close to blood flow when the THV is implanted.

[0204] exist Figure 8 In the embodiment, the support stent 10 is self-expanding. However, in other embodiments, the support stent may not be self-expanding. In these embodiments, the support stent can be made of a suitable ductile material (such as stainless steel). In addition, a mechanism for expanding the support stent can be included as part of the delivery system 100. For example, the support stent can be arranged around the balloon of a balloon catheter in a compressed state. The balloon catheter can have an axle rod inside the inner catheter 118. Because the stent 10 is not self-expanding, the distal portion of the guide catheter 102 does not need to extend on the compressed support stent. During the delivery of the support stent, the support stent, the balloon catheter, the inner catheter 118 and the stent delivery catheter 108 can be advanced from the distal end of the guide catheter 102. The balloon portion of the balloon catheter can be inflated, causing the support stent to expand. The balloon portion can then be deflated and the balloon catheter is withdrawn into the delivery system 100 to remove the balloon from the inside of the support stent, while the support stent remains connected to the inner catheter for the placement of the support stent. Delivery of the stent is otherwise performed as in the described embodiment using the self-expanding stent 10 .

[0205] Fig. 9 An introducer sheath 220 is shown entering the left ventricle through a perforation 222 and over a guidewire 224 extending upward through the aortic valve 210. The clinician positions the distal tip 221 of the introducer sheath 220 just to the inflow side of the aortic valve 210. The position of the introducer sheath 220 relative to the aortic valve 210, as well as the position of other elements of the system, can be monitored using radiopaque markers and fluoroscopy, or using other imaging systems.

[0206] Fig.10 The balloon catheter 230 is shown advanced over the guide wire 224 and through the introducer sheath 220. Finally, as Fig.11 As shown, the THV 250 is located at the aortic valve and between the native aortic leaflets. Fig.11 Also shown is the introducer sheath 220 extending from its Fig.10 A radiopaque marker may be provided on the distal end of the introducer sheath 220 to more accurately determine its position relative to the valve 210 and the balloon 232. To better illustrate the components of a delivery system for a THV, Figure 10 to Figure 11 The front third of the support bracket 10 or the corresponding outer and inner forks of the outer and inner forks are not shown. In addition, in order to illustrate the relative position of the support bracket 10 on the THV 250, Figure 12 to Figure 13 The front third of the support stent 10 and the front face of the THV 250 are shown, but the portion of the native heart valve fixed by the front face of the support stent 10 is not shown. However, it should be understood that the corresponding leaflets of the native heart valve are fixed between the support stent 10 and the THV 250.

[0207] Again, precise placement of the THV 250 can be achieved by positioning radiopaque markers on its distal and proximal ends. In some embodiments, the clinician can adjust the position of the valve 250 by actuating a steering or deflection mechanism within the balloon catheter 230. In addition, the rotational orientation of the valve 250 relative to the cusps and commissures of the native aortic valve can be adjusted by twisting the balloon catheter 230 from its proximal end and observing specific markers on the valve (or balloon catheter) under fluoroscopic examination. Fig.11 One of the coronary ostia 280 leading to one of the ascending aortic sinuses is also shown, and one skilled in the art will appreciate that it is important not to occlude both coronary ostia with a prosthetic valve 250 .

[0208] Fig.11 The THV 250 is shown in a collapsed or unexpanded state crimped around the balloon 232. When the clinician is satisfied with the proper placement and rotational orientation of the valve 250, the balloon 232 is expanded to engage the THV 250. Fig.12 The support stent 10 is shown. The engagement of the support stent 10 to the exterior of the THV 250 clamps the leaflets of the aortic valve between the support stent and the THV 250, and thereby secures the THV within the annulus of the aortic valve. Once secured in this position, the inner catheter 118 of the delivery system 100 can be retracted, causing the prongs of the inner fork 138 to disengage from the retaining arms of the support stent 10. Once the prongs of the inner fork 138 are disengaged, the prongs of the outer fork 140 can be disengaged from the retaining arms by retracting the stent delivery catheter 108. Once disengaged from the support stent, the delivery system 100 can be retracted from the aortic arch and removed from the patient.

[0209] It should be noted that valve 250 can take a variety of different forms and can include an expandable stent portion that supports the valve structure. The stent portion desirably has sufficient radial strength to keep the valve at the treatment site and fixedly engage the support stent 10. Additional details about balloon expandable valve embodiments that can be used in conjunction with the disclosed technology are described in U.S. Patent Nos. 6,730,118 and 6,893,460, both of which are expressly incorporated herein by reference.

[0210] Once the valve 250 is properly implanted, as Fig.13 As shown, the balloon 232 is inflated and the entire delivery system including the balloon catheter 230 is withdrawn over the guidewire 224. The guidewire 224 can then be withdrawn, followed by the introducer sheath 220. Finally, the purse-string suture 260 at the apex of the left ventricle can be tied and tied to close the perforation.

[0211] Figures 14 to 16 Another embodiment of a support stent or frame 310 that can be used to help secure a THV to the interior of a native heart valve, such as an aortic valve, is shown. Specifically, Fig.14 is a perspective view of the support bracket 310, Fig.15 is a top view of the support bracket 310, and Fig.16 3 is a side view of support bracket 310. Like support bracket 10, support bracket 310 has a generally annular or ring-shaped body formed of a suitable shape memory metal or alloy, such as spring steel, cobalt chromium alloy (Elgiloy ), or nitinol. The support stent 310 can also be radially compressed to a smaller profile and can self-expand when deployed to its functional size and shape. However, in other embodiments, the support stent 310 does not self-expand.

[0212] The support stent 310 includes a generally cylindrical main body portion 320 and an edge portion 330. The support stent 310 can be a grid structure, which can be formed by, for example, a plurality of elements, wherein about half of the elements are angled in a first direction and about half of the elements are angled in a second direction, thereby creating a cross or diamond pattern. In the illustrated embodiment, the edge portion 330 has a larger diameter than the main body portion 320 and is formed as an extension at the bottom area of ​​the main body portion that is folded outward from the main body portion and folded back toward the top area of ​​the main body portion. The edge portion 330 thus forms a U-shaped edge or lip around the bottom area of ​​the support stent 310. Typically, the edge portion 330 is designed to have a diameter slightly larger than the wall of the aortic arch surrounding the aortic valve. Therefore, when the support stent 310 is delivered to the aortic valve and deployed at the aorta, the edge portion 330 expands to engage the surrounding aortic wall and frictionally fix the support stent 310. At the same time, the main body portion 320 defines an interior in which the expandable THV can expand and the interior further engages the native leaflets of the aortic valve. Therefore, the main body portion 320 is similar to the above-mentioned Figures 1 to 12 The illustrated support stent 10 operates in the same manner, with the edge portion 330 of the support stent 310 operating to secure the support stent in place by engaging the aortic wall surrounding the aortic valve.

[0213] like Fig.14 and Fig.16As best shown, the support stent 310 further includes retaining arms 321, 322, 323, which can be used to help position and deploy the support stent 310 into its proper position relative to the native aortic valve. The retaining arms 321, 322, 323 can have corresponding holes 326, 327, 328. Typically, the retaining arms 321, 322, 323 are arranged in a manner similar to the above Figures 1 to 12 The retaining arms 21 , 23 , 25 described in the exemplary embodiment shown are designed and function in a similar manner.

[0214] Figure 17 to Figure 18 An exemplary procedure for deploying the support bracket 310 and securing the THV 340 inside the support bracket is shown. Figure 17 to Figure 18 is a cross-sectional view through the left side of the patient's heart, which illustrates the actions performed when delivering the support stent 310 through the aortic arch to the aortic valve. For the sake of brevity, certain details of the delivery system of the THV 340 are omitted. Additional details and alternative embodiments of the delivery system for the THV 340 that can be used with the support stent described herein are discussed in U.S. Patent Application Publication No. 2008 / 0065011 (U.S. Application Serial No. 11 / 852,977) and U.S. Patent Application Publication No. 2007 / 0005131 (U.S. Application Serial No. 11 / 152,288), which applications are expressly incorporated herein by reference.

[0215] Fig.17 The outer catheter 352 of the delivery system 350 (which can be a guide catheter) is shown as it is advanced through the aortic arch 302 into a position near the surface of the outflow side of the aortic valve 304. The delivery system 350 can be inserted through the patient's femoral artery in a retrograde direction and advanced into the aorta. Fig.17 Also shown are a stent delivery catheter 354, an inner catheter 356, and a supporting stent 310. Fig.17 Also shown are outer fork 360 and inner fork 362 that couple support stent 310 to the distal ends of stent delivery catheter 354 and inner catheter 356, respectively.

[0216] More specifically, Fig.17 The support stent 310 is shown after it has been advanced through the distal end of the guide catheter 352 and has assumed its final, uncompressed shape in a position adjacent to the aortic valve 304. To better illustrate the components of a delivery system for a THV, Figure 17 to Figure 18 Not shown is the entire front side of the support stent 310 or the corresponding valve leaflets secured by the front side of the support stent 310. However, it should be understood that in practice the entire support stent 310 is present and incorporates the corresponding leaflets of the native heart valve.

[0217] The support stent 310 can be placed adjacent to the aortic valve 304 so that the edge portion 330 of the support stent engages the walls surrounding the aortic valve 304 and applies an outward force to these walls, thereby fixing the support stent 310 in the aorta. This placement can be achieved by, for example, advancing the guide catheter 352 to a position directly adjacent to the aortic valve 304, while the stent delivery catheter 354 and the inner catheter 356 are not deployed and while the support stent 310 remains in its compressed state. The guide catheter 352 can then be retracted while the stent delivery catheter 354 and the inner catheter 356 are maintained in a suitable position, thereby allowing the support stent 310 to expand toward its natural shape. As with the above-mentioned delivery system 100, the position of the guide catheter 352 and the support stent 310 relative to the aortic valve 304, as well as the position of other elements of the system can be monitored using radiopaque markers and fluoroscopic fluoroscopy, or using other imaging systems, such as transesophageal echo, transthoracic echo, IVUS, or radiopaque injectable dyes.

[0218] Once the support stent 310 is positioned in the desired position adjacent the aortic valve 304, the prongs of the inner fork 362 can be disengaged from the corresponding holes of the retaining arms of the support stent 310. For example, the inner catheter 356 can be retracted into the interior of the stent delivery catheter 354, thereby releasing the support stent 310 from the outer fork 360 and the inner fork 362. The delivery system 350 can then be retracted from the aorta and removed from the patient.

[0219] As for the support stent 310 fixed to the aortic valve, a THV (such as any of the THVs described above) can be introduced. Figures 7 to 13 Compared to the procedure shown in the drawings, a delivery system having a delivery catheter advanced through the patient's aorta can be used to deliver the THV. In other words, a transfemoral approach can be used. For example, any of the exemplary systems and methods described in U.S. Patent Application Publication No. 2008 / 0065011 (U.S. Application Serial No. 11 / 852,977) or U.S. Patent Application Publication No. 2007 / 0005131 (U.S. Application Serial No. 11 / 152,288) can be used with the support stent 310. Alternatively, a transfemoral approach can be used. Figures 7 to 13 The transapical approach is shown in .

[0220] Fig.18 A delivery system 380 is shown that includes an outer catheter 382 (which can be a guide catheter) extending through a guide catheter and a balloon catheter 390. The balloon catheter 390 has a balloon at its distal end on which the THV is mounted. As with the delivery system 350, the delivery system 380 can be inserted through the femoral artery of the patient and advanced into the aorta in a retrograde direction. Fig.18Also shown is a guide wire 392 that has first been inserted into the patient's vasculature and advanced into the left ventricle. The delivery system can then be inserted into the body and advanced over the guide wire 392 until the THV is seated within the interior of the aortic valve. As shown, the THV is not only within the interior of the aortic valve 304, but also within the main body portion of the support stent 310.

[0221] Fig.18 The THV 340 is shown in a compressed (or unexpanded) state with the balloon portion crimped around the balloon catheter 390. When the clinician is satisfied with proper placement, the balloon of the balloon catheter 390 can be expanded to cause the THV 340 to expand and push the native leaflets of the aortic valve toward the support stent 310, thereby securing the THV within the annulus of the aortic valve. Once the THV 340 is properly implanted, the balloon of the balloon catheter 390 is deflated, and the entire delivery system 380 including the balloon catheter is withdrawn over the guide wire 392. The guide wire 392 can then be withdrawn.

[0222] Other methods of delivering the stent and THV to the aortic valve or any other heart valve are also possible. For example, in certain embodiments, the stent and THV are surgically delivered to the desired heart valve (e.g., during open heart surgery). Furthermore, in certain embodiments utilizing surgical delivery of the stent and THV, a non-compressible stent and / or THV is used. Exemplary Embodiments for Treating Valvular Insufficiency and Vascular Aneurysms

[0223] Aortic insufficiency (AI) can cause dilation of the ascending aorta, leading to an aneurysm and the aortic annulus. To prevent further dilation, embodiments of the present invention provide for anchoring of a deflector that directs blood away from the aneurysm while simultaneously treating the insufficient heart valve.

[0224] like Fig.19 As shown, one embodiment of a medical device 410 for treating AI (or any other vascular aneurysm or defect associated with a valve) includes a support structure 412, a stent 414, an artificial valve 416, and a deflector 418. The support structure 412 is similar to or identical to the support structures described above and is configured to cooperate with the artificial valve 416 to clamp the native valve therebetween and to provide an anchor for the stent 414 extending into the aorta and supporting the deflector 418, which is positioned to reduce blood flow proximate the aneurysm.

[0225] For example, Fig.194, a support structure 412 (stent or frame) includes peaks 420, 422, 424 and valleys 430, 432, 434 and retaining arms 421, 423, 425 defining holes 426, 427, 428. Similar to the other embodiments of the support structure disclosed herein, a range of variations are possible for the anchoring stent 414 and the artificial valve 416 and the deflector 418.

[0226] As noted above, it should be understood that the shape of the support stent or frame 410 can vary depending on the embodiment. For example, in some embodiments, the support stent is not sinusoidal or is otherwise shaped in the z-plane. In other embodiments, the support stent is shaped as a cylindrical band or sleeve. In general, the support stent or frame can be any shape that defines an interior through which the THV can be inserted, thereby causing the native leaflets of the aortic valve (or other heart valve) to be clamped or fixedly held between the support stent and the THV. In addition, the support stent can have a more complex structure. For example, although Fig.19 While the support stent shown is formed from a single annular member (or strut), the support stent can include multiple annular elements that interlock or are otherwise connected to one another (eg, via multiple longitudinal members).

[0227] Fig.19 The artificial valve 416 of the illustrated embodiment is Figure 1 As noted above, however, it should be understood that this particular use is for illustrative purposes only and should not be construed as limiting. Rather, embodiments of the disclosed support structures can be used to secure a wide variety of THVs delivered through a variety of mechanisms (e.g., self-expanding heart valves, other balloon-expandable heart valves, etc.). For example, any of the embodiments described in U.S. Pat. No. 6,730,118 can be used with embodiments of the disclosed support structures.

[0228] like Fig.19 As shown, stent 414 is a scaffold coupled to support structure 412 and extending from the support structure into the aorta (and over the insufficiency portion of the aorta). Stent 414 has a proximal end 430, a distal end 432, and a plurality of interconnected struts 434 defining a plurality of pores 436.

[0229] exist Fig.19 In the embodiment of the present invention, the proximal (relative to the heart) end 430 of the stent 414 is connected or coupled to the support structure 412 by being formed with the support structure 412 or by attachment of a wire or other support. For example, the support structure 412 and the stent 414 including a plurality of interconnected struts 434 can be cut from a single metal tube using a laser. As described below, when each portion of the medical device 410 is delivered, the coupling can also be by assembly after independent formation, including in vivo assembly.

[0230] Extending in the distal direction from the proximal end 430 is the body of the stent 414 formed of interconnecting struts 434 defining interspaces 436 therebetween. Preferably, the interconnecting struts 434 are formed to promote flexibility and facilitate delivery through tortuous pathways and extension over the aortic arch. For example, the strut pattern may be as follows: Fig. 20 4 (a flat portion of a laser cut blank prior to expansion) and includes a plurality of rings 438 formed by end-to-end connected sinusoidal struts, wherein the rings are connected by a plurality of angled flexible connectors 440. Moreover, the rings 438 can be formed to have variable lengths and the connectors 440 can be selectively positioned to promote directional preferences for flexibility and / or variations in pore size therebetween.

[0231] An example of a flexible stent structure is LIFESTENT manufactured by CRBARD, which has a multi-dimensional helical structure that facilitates its use in the tortuous paths of the surrounding vascular system. Aspects of LIFESTENT are described in U.S. Patent No. 6,878,162 to Bales et al., entitled "Helical Stent Having Improved Flexibility and Expandability."

[0232] This flexibility is advantageous for the treatment of AI because when the stent 414 is extended along the aortic arch, the stent 414 has a tightly curved configuration with an outer long curvature 442 and an inner curvature 444. Along the outer curvature 442, the pore size can be larger to allow for a longer path length, which can be woven into the stent through selective cutting and forming of struts and pores and / or can occur due to mechanical application for insertion and delivery into the aortic arch. Similarly, the inner curvature 444 can be woven in through the selection of strut structure and / or due to delivery.

[0233] In addition, the stent 414 may include structures that promote frictional engagement or mechanical engagement with a surrounding lumen (e.g., the aorta) where the lumen is in proximal contact with the stent. For example, the struts 434 and pores 436 may have patterns that promote frictional engagement, or may have barbs or hooks or micro-anchors or flared portions formed thereon to mechanically engage the lumen and promote the role of the support structure 412 in securing the medical device 410.

[0234] The distal end 432 of the stent 414 is placed in the aortic arch away from the branching arteries extending outside the aorta (e.g., the brachiocephalic, common carotid, and left subclavian arteries). The distal end 432 may be the terminal end of the rearmost row of loops 438 or may include its own retaining arms 446 defining holes 448. The use of retaining arms 446 and holes 448 enables the use of Figure 3and Figure 4 The delivery device 110 shown in and described above. The distal end 432 may also include a structure configured to engage the surrounding lumen for additional fixation of the medical device 410. For example, it may include a hook or barb or a micro-anchor.

[0235] On the other hand, the aperture 436 may include a relatively large aperture structure that is positioned above and near the branch artery. This promotes perfusion of the branch artery, such as by being positioned above the branch artery at the aortic arch or closer to the valve for communicating with the coronary artery. The aperture structure is relatively large compared to the remaining aperture that is configured to support the lumen wall or reduce blood flow or further vascular expansion close to the aneurysm. On the other hand, the aperture size may be selected to protect the branch artery from embolic debris so as to act as a local deflector of such debris.

[0236] The length of the device 410 including the support structure 412 and the stent 414 can be sufficient to extend from the native leaflets through the sinuses of Valsalva over the aortic arch into the ascending aorta and potentially into the descending aorta. For example, the length of the device 410 can be 30 mm to 100 mm or longer. The stent 414 can also be tapered, smaller at the annulus and larger at the ascending aorta, can be cylindrical, or can have a tip with a larger diameter for sealing and anchoring, such as Fig.21 shown.

[0237] Once the support structure 412 and stent 414 are deployed, they act like a scaffold or anchoring device for other devices to be deployed therein, such as a prosthetic valve 416, and one or more deflectors 418, which are delivered and anchored as described above.

[0238] exist Fig.19 In , deflector 418 is a relatively impermeable stent graft or graft (eg, impermeable to blood flow and configured for placement over an aneurysm within the aortic arch so as to direct blood flow away from the aneurysm). Fig.19 The deflector 418 of the embodiment includes a deflector stent 450 supporting a tubular graft material 452 that extends around the deflector stent. The deflector 450 is installed in the stent 414 just as a graft is installed in a blood vessel without the stent 414. For example, the deflector 450 can be delivered by a catheter that extends retrograde into the blood flow in the aorta or a catheter that extends from the ventricle and across the aortic valve, and then expands (or is allowed to expand) once the desired location is reached.

[0239] Advantageously, the stent 414 shields the aneurysm from the expansion pressure of the deflector 418 and the deflector can have a smaller expanded diameter than the aneurysm and still provide for a secure anchor.

[0240] Fig.19The deployment of the medical device 410 may include first deploying the support structure 412 and the stent 414 (if they are integrally attached to each other). Then, the THV prosthetic valve 416 is delivered through the support structure 412 and the stent 414, thereby anchoring it in the proximal end of the device (support structure 412 or stent 414). The stent graft or graft deflector 418 is deployed in the stent 414, thereby covering the area with the aneurysm and avoiding the branch arteries and the associated larger pores of the stent 414. The deflector 418 then redirects the pulsating blood away from the aneurysm to prevent the dissection, and the new valve prosthesis 416 will ensure that the correct blood flow is restored.

[0241] Although the deflector 418 is Fig.19 414, the term "deflector" should be interpreted broadly herein to include any structure that is used to reduce (reduce) blood flow against a selected portion of a vessel wall. For example, multiple deflectors 418 in the form of grafts or stent grafts can be delivered and positioned to address anatomical variations in the size and placement of (one or more) aneurysms. Moreover, deflector 418 need not be a tubular structure, but can be a sheet or shield-like material anchored to one side of stent 414. Moreover, deflector 418 need not be separately attached, but can be a portion of stent 414 with reduced permeability (such as through a polymer coating). Fig.21 Another example is shown where the stent 414 is covered by a deflector 418 during delivery.

[0242] Fig. 22 Another example is shown, in which the stent 414 is covered by a deflector 418 in the form of a balloon 454. The balloon not only deflects the blood flow, but can also be inflated so as to expand into and fill the space between the stent 414 and the aneurysm wall. The inflation can be by a fluid, such as saline, wherein the balloon can include a one-way check valve that stops the saline from flowing out after the attachment of the inflation lumen. Moreover, the inflation can be by setting or curing or thickening polymers or other fluids and thus can maintain the filled shape after the intervention is over. Preferably, the expansion force of the balloon 454 is low enough so as not to further expand the aneurysm, but at the same time causes the balloon to acquire the shape of the aneurysm space. The balloon can therefore be composed of a very flexible material, such as silicone that expands at low pressure and / or can even include a fabric material. For fabric materials, another advantage is that if the fabric balloon is made to fit the aneurysm, the fabric material can have a limit to expansion and will protect the aneurysm from dissection.

[0243] Fig.23Another example is shown where a stent 414 is covered by a deflector 418 in the form of a foam sleeve 456. The foam can be an open cell foam or a closed cell foam to promote friction with the surrounding lumen at the initial implant. If open cell, blood will grow in and create a barrier for blood not to travel along the aortic wall. The foam can be configured for compression of up to 300%.

[0244] Moreover, the foam can be configured to absorb blood, such as by being hydrophilic, and expand in the blood and fill the space between the stent 414 and the lumen. An outer skin or impermeable layer can also be applied to the stent 414 or the foam sleeve 456 so that the foam does not fall off or break off and cause embolism. The outer skin or impermeable layer inhibits the leakage of blood through the foam into the aortic wall. For example, the inner surface of the foam sleeve 456 can have a relatively impermeable outer skin (such as a closed-cell foam) to promote the advancement of blood through it, while the outer surface is open-cell and permeable for expansion.

[0245] The foam may also have coagulation properties that promote the accumulation of clots to help secure the medical device 410 and fill the aneurysm space. The foam may include, for example, a flexible ester polyurethane, a reticulated open-cell adhesive foam with a pore size of 80-100 ppi and a density of 5.4-6.3 pcf. Furthermore, a thick fabric sleeve (such as a hydrophilic fabric or foam) that expands in response to absorbing blood may be used.

[0246] During delivery, the foam sleeve 456 is crimped down with the stent 414 and then placed in the patient's aorta. During expansion, the stent 414 expands and maintains its more rigid shape, while the foam is also able to expand and take on the current shape of the aorta. The foam advantageously fills the space between the stent 414 and the aneurysm wall, thereby preventing blood (continued pulsating forces) from reaching the aneurysm. The foam sleeve 456 creates a seal within the aorta, forcing blood to pass through the diameter of the stent 414. It also has an effective friction or outward force on the aortic wall to limit movement.

[0247] Fig.24 Another example is shown where the deflector 418 has an annular or donut shape, such as a foam or balloon ring. As the length of the ring decreases, the ring can be positioned at the location of the aneurysm, thereby blocking the flow of blood to that particular segment of the aortic wall.

[0248] Fig.25 Another example is shown including two annular or ring-shaped deflectors 418 on the stent 414, which help the device remain in the aorta. In this variation, the rings can be placed on opposite sides of the aneurysm and seal the aneurysm against blood flow. The rings can be foam, balloons or other expansion members. Depending on the number and placement and size of the aneurysms, there may be several (more than two) ring deflectors.

[0249] like Fig.28As shown, the deflector 418 may include micro-anchors that are attached to the foam or balloon segments to aid retention if the expansion force of the foam or balloon is not adequate within the larger aorta.

[0250] In another aspect, the deflector 418 may include a mechanical clot promoter, such as a wire, coil, or spring, that fills the space between the stent 414 and the aneurysm wall to promote embolization therebetween.

[0251] Fig.26 Another embodiment of the present invention is shown in which the deflector 418 (in the form of a graft) may include a seal 458 in the form of a slit configured to allow access to the interior of the stent 414. For example, the seal 458 may include an overlap or lip of graft material that seals itself by closing after the delivery tool is removed. Alternatively, the seal may be a valve, such as a duckbill valve.

[0252] Grafting 418 with seal 458 can be used during "transaortic" THV transplantation, where the graft is first deployed in percutaneous delivery. The THV is then passed through the chest wall with a delivery tool (e.g., catheter) and through the crack in the aorta (aortotomy) and finally delivered through the crack or seal 458 in the graft. The crack is then sealed around the delivery tool to prevent blood loss. The THV expands to a suitable position in the support structure 412 or stent 414. When the delivery tool is removed, seal 458 is closed, thereby allowing the aorta to be sutured when blood is not spilled. Grafting 418 can be left behind, or it can be retrieved after the procedure ends. This seal 458 can be used in a series of embodiments with deflector 418, including embodiments disclosed herein.

[0253] Fig. 27 Another embodiment is shown in which the deflector 418 has an hourglass shape and is made of an elastic material that deflects in response to the increased blood pressure of the heartbeat and adds additional pumping action when arterial pressure drops. For example, the hourglass shape is formed by an elastic wall that deflects under pressure and returns to its original shape when the pressure drops. On the other hand, the graft wall can be relatively thick for increased elasticity and additional pumping action.

[0254] In another embodiment, two anchoring stents can be connected by an elastic tube (e.g., made of silicone). One of the anchors is deployed in the STJ (just above the native valve) and the other anchor is deployed on the other end of the aneurysm somewhere in the ascending aorta before the bifurcation. The elasticity of the tube assists the pumping action of the heart.

[0255] Preferably, each of the medical devices 410 described herein is capable of being substantially compressed. For example, the device 410 including the embodiment of the stent 414 and its foam sleeve 456 can be compressed or rolled to a diameter of 8 mm or less. When uncompressed, the diameter can be 50 mm to 90 mm.

[0256] The method of using the medical device 410 disclosed herein includes delivering a support structure 412 to a position on the surface of the outflow side of the patient's native heart valve or a position adjacent to the surface, wherein the support structure defines an interior of the support structure. An expandable artificial heart valve 416 is delivered into the native heart valve and into the interior of the support structure. When the expandable artificial heart valve 416 is inside the support structure and when the support structure is at a position on the surface of the outflow side of the native heart valve or a position adjacent to the surface, the expandable artificial heart valve 416 is expanded. This causes one or more of the native heart valve leaflets to be frictionally fixed between the support structure 412 and the expandable artificial heart valve 416.

[0257] A stent 414 coupled to the support structure 412, either formed together or attached later, extends into a blood vessel (such as the aorta) extending from a native heart valve. A deflector 418 is already present on the stent 414 and / or is delivered into and attached to the stent 414. Blood flow adjacent to the blood vessel is reduced by the deflector 418.

[0258] The method may also include delivering stent 414 (or a portion thereof) to a location adjacent to support structure 412 and coupling the stent to the support structure prior to extending the stent into the blood vessel. Furthermore, deflector 418 may be delivered to a support location on stent 414 and coupled to the stent in the body. Additionally, where stent 414 has multiple portions, the portions can be delivered separately and coupled to one another in the body. Preferably, the method includes preventing the artery from extending from the blood vessel when the deflector is positioned.

[0259] Furthermore, the method may include expanding the deflector 418 to fill at least a portion of the space between the outer surface of the stent 414 and the blood vessel.

[0260] Fig.29 Another embodiment of a support stent or frame 500 that can be used to treat valvular insufficiency (e.g., aortic insufficiency, mitral insufficiency, etc.) or to help secure a THV within the interior of a native heart valve is shown. The support stent 500 includes an annular body 501 formed by a plurality of angular struts 502 arranged in a zigzag pattern and having one or more apexes 504 formed by the intersection of two adjacent struts. The struts 502 can be configured so that there is a gap 506 between adjacent struts below the apex 506, which gap receives portions of two adjacent leaflets that form the commissure of the native valve, such as Fig.30In certain embodiments, the support stent has gaps 506 for each commissure of the native valve in which the support stent is to be implanted. Fig.29 and Fig.30 As shown, when the support stent 500 is intended to be implanted at the aortic valve or pulmonary valve, the support stent 500 desirably has three angularly spaced gaps 506, wherein each gap is disposed at the commissure of the native valve when the support stent 500 is implanted. The gaps 506 may be sized to clamp or clip adjacent leaflets to each other at the corresponding commissures. Similarly, if the support stent is configured to be implanted at the native mitral valve, the support stent desirably has two gaps 504. In this way, the support stent 500 can hold the native valve leaflets together or clamp the native valve leaflets together, thereby reducing the effective orifice area of ​​the valve, which in turn can reduce regurgitation through the valve.

[0261] If stent 500 alone is insufficient to reduce regurgitation or if the native valve deteriorates further over a period of time after implantation of stent 500, stent 500 may be used as a Figures 10 to 13 With the docking shown, the THV can be deployed within the native valve. In some embodiments, by using the stent 500 as a docking for the THV, the stent 500 and the THV can be implanted in the same procedure. As can be appreciated, compared to Figures 1 to 13 In the implantation step shown, the use of stent 500 simplifies the procedure because stent 500 can be "clipped" to the commissures of the native leaflets and, once deployed, maintain its position, which avoids the need to use one catheter to hold the stent in place while another catheter (such as Fig.12 The need for THV transplantation is shown.

[0262] refer to Fig.31 and Fig.32 , the support stent 500 can also be used to treat native valve insufficiency by reducing the diameter of the valve annulus. The support stent 500 can be anchored in the valve annulus by one or more micro-anchors 508 including one or more sets of barbs 510. Exemplary embodiments of micro-anchors that can be used with the disclosed technology can be found in U.S. Patent Application No. 13 / 910,975 (U.S. Publication No. 2013 / 0331930), which is incorporated herein by reference. Fig.31As shown, the micro-anchor 508 can be placed in the gap 506 adjacent to the top 504 of the support stent and can be embedded in the tissue of the valve annulus. One or more sutures 512 coupled to the micro-anchor 508 can extend upward toward the delivery system (not shown) and can include one or more suture fixation devices, such as suture clips 514. The suture clips 514 can be configured to travel along the sutures 512 in the direction indicated by arrows 516 (i.e., toward the micro-anchors 508). When tension is applied to the sutures 512 (by pulling the sutures upward and / or pushing the suture clips downward), the suture clips can prevent the sutures 512 from traveling in the opposite direction through the suture clips 514 (i.e., the suture clips can prevent the sutures from traveling downward relative to the clips). Exemplary embodiments of suture fixation devices that can be used with the technology can be found in U.S. Patent Application No. 13 / 938,071 (U.S. Publication No. 2014 / 0031864), which is incorporated herein by reference.

[0263] Once the micro-anchors 508 are implanted in the tissue of the annulus, tension can be applied to the sutures 512 to pull the micro-anchors 508 toward each other, thereby reducing the diameter of the annulus ( Fig.32 ). Suture clip 514 maintains tension on suture 512, thereby keeping the support stent and surrounding tissue in a reduced diameter state after implantation. In this way, support stent 500 can be used to reduce the diameter of the valve annulus.

[0264] In other embodiments, the support stent 500 can be implanted in a procedure where the micro-anchors 508 are deployed adjacent to the commissures of the native valve, wherein each micro-anchor 508 is provided with a suture 512 that can extend outside of the delivery device and / or the body. When implanted at the native aortic valve, three micro-anchors 508 (each with a corresponding suture) can be implanted. The suture 512 can be threaded through an opening in the top 504 of the support stent 500, which can then be advanced along the suture until it is positioned against the aortic surface of the native leaflet. A suture clip 514 can be advanced downwardly along the suture 512 to tighten the suture and pull the surrounding tissue inward to reduce the diameter of the native valve annulus (e.g., Figure 31 to Figure 32 described above).

[0265] In an alternative embodiment, the support stent 500 can be made of a self-expanding material (e.g., nitinol) and delivered and deployed using an expansion mechanism (e.g., a balloon catheter). When the support stent 500 is adjacent to the native valve, the expansion mechanism over-expands the support stent (i.e., radially expands the support stent beyond its functional size) (such as by inflating the balloon of the balloon catheter) and places the support stent against the aortic surface of the native valve. The support stent 500 can have barbs or anchors 508 that can engage, penetrate and / or grab adjacent tissue when the support stent 500 is placed against the native tissue. Instead of or in addition to the barbs or anchors, the support stent 500 can be configured to clip onto the commissures of the native valve when the commissures are placed in the gap 506. The expansion mechanism then releases the support stent 500 (such as by deflation of the balloon), thereby allowing the support stent to shrink or return to its natural size or functional size, pulling the surrounding tissue inward to reduce the size of the native valve ring.

[0266] Alternatively, the size of the aortic annulus can be reduced by suturing a functionally sized support stent 500 to the aortic valve.

[0267] Fig.33 Another embodiment of a support stent or frame 600 that can be used to treat heart valve insufficiency or to help secure a THV within the interior of a native heart valve (such as an aortic valve) is shown. The support stent 600 includes an annular body 601 formed by a plurality of angular struts 602 arranged in a zigzag pattern. The support frame 600 can include one or more leaflet engagement mechanisms 603. The leaflet engagement mechanisms 603 can include a plurality of pairs of leaflet engagement members 604 secured to corresponding struts 602 below one or more apexes 606, the one or more apexes 606 being formed by the intersection of two adjacent struts 602. Each leaflet engagement member 604 has a fixed end portion 608 and a free end portion 610, the fixed end portion 608 being secured to the corresponding strut. The leaflet engagement members 604 extend upward toward the apex 606 and toward each other. In their normal unbiased (i.e., undeflected) state, the leaflet engagement members 604 can be configured so that there is a small gap between the respective free end portions 610 that receives portions of two adjacent leaflets 616 that form the commissure of the native valve, as further described below. The struts 602 and leaflet engagement members 604 can be laser cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) so that the leaflet engagement members 604 are integral with the support stent. In other embodiments, the leaf springs 604 can be formed separately and welded to the struts 602.

[0268] In certain embodiments, the support stent has a pair of leaflet engagement members 604 for supporting each commissure of a native valve in which the support stent is to be implanted. Fig.33 As shown, when the support stent 600 is intended to be implanted at the aortic valve or pulmonary valve, the support stent 600 desirably has three pairs of angularly spaced leaflet engagement members 604, and each pair is disposed below a top 606, which is disposed at the commissures of the native valve when the support stent 600 is implanted. If the support stent is configured to be implanted at the native mitral valve, the support stent desirably has two pairs of leaflet engagement members 604. Although less desirable, in some embodiments, the number of leaf spring pairs can be less than the number of commissures of the native valve in which the support frame will be implanted. Similar to the support stent 310, the support stent 600 can have a retaining arm 612 for releasably securing the support stent 600 to a delivery device (e.g., the delivery device 350).

[0269] Fig.34 The stent 600 is shown implanted in the aortic root behind the leaflets 616 of the aortic valve 614. To deliver and deploy the stent at the implantation site, the stent 600 can be mounted on a delivery device 350 ( Fig.17 ) and delivered to the vicinity of the native aortic valve, as described in detail above. When the support stent 600 is adjacent to the aortic valve 614 (for example, within or just above the aortic root), the support stent 600 can be deployed from the catheter 352, allowing the support stent to expand to its functional size. Each pair of leaflet engagement members 604 is rotationally aligned within one of the commissures of the aortic valve. Thereafter, the delivery device 350 is further advanced toward the aortic valve, causing each pair of leaflet engagement members 604 to slide on a pair of native leaflets 616 of one of the commissures of the aortic valve. The gap between the free end portions 610 of the leaf springs is such that the insertion of the native leaflets 616 can place the leaf springs in tension and clamp the native leaflets between the leaf springs. Once the native leaflets are captured by the support stent 600, the support stent can be released from the delivery device 350. The compression force of the leaflet engagement members 604 against the native leaflets 616 is sufficient to overcome the blood flow to keep the support stent 600 in the proper position. Thereafter, if desired, the THV can be implanted within the interior of the aortic valve 614 (e.g. Fig.18 ) and expands against the native leaflet 614, which in turn compresses the support stent radially outward.

[0270] Fig.35An improvement of a support stent 600 is shown having leaflet engagement members 604 with ball-shaped free end portions 618 that are configured to contact each other in their normal unbiased (undeflected) state. The curved outer surfaces of the ball-shaped free end portions 610 can help engage autologous leaflets placed between the ball-shaped free end portions 618 without damaging the leaflets. During insertion of the autologous leaflets between the leaflet engagement members 604, the leaflet engagement members 604 can flex to move the ball-shaped free end portions 618 upwardly away from each other to allow the leaflets to slide between the ball-shaped free end portions 618 (e.g., Fig.35 described above).

[0271] Fig.36 Another improvement of a support stent 600 is shown having a leaflet engagement member 604 with a curved free end portion 620, which can improve the retention force against the leaflets while minimizing the bulkiness of the leaflet engagement member 604. Fig.37 The implant is shown in the aortic root with a pair of leaflets 616. Fig.36 The support bracket captures the pair of leaflets 616 between the free end portions 620 of the leaflet engagement member 604.

[0272] Fig.38 Another improvement of the support stent 600 is shown having a single leaflet engagement member 604 beneath one or more selected apexes 606. In this embodiment, the leaflet engagement member 604 is configured to capture a pair of leaflets 616 between a bulbous free end portion 618 of the leaflet engagement member 604 and a projection 622 extending toward the leaflet engagement member 604. In the illustrated embodiment, the projection 622 is shaped to entangle or bind adjacent leaflets 616, thereby helping to hold the leaflets 616 in place between the leaflet engagement member 604 and the projection. In an alternative embodiment, the leaflets 616 can be captured between the bulbous free end portion 618 of the leaflet engagement member 604 and the surface of the adjacent strut 602.

[0273] Fig.39 Another modification of the support frame 600 is shown in which the leaflet engagement member 604 is configured to extend from a distal tip 624 formed by the intersection of two adjacent struts 602 at the outflow end of the support frame 600 .

[0274] Fig.40Another embodiment of a support strut 700 is shown including an annular body 701 (shown as flat) formed by a plurality of struts 702. A leaflet engagement mechanism 705 including a plurality of pairs of leaflet engagement members 706 configured to capture a corresponding pair of autologous leaflets is disposed below one or more selected top ends 704 of the support stent. In the illustrated embodiment, each leaflet engagement member 706 has a first end 708 fixed to the strut 702 and a second end 710 fixed to the same strut 702. Each leaflet engagement member 706 can have a plurality of curved segments 712 extending between the first end 708 and the second end 710, respectively, thereby allowing a pair of adjacent leaflet engagement members 706 to be deflected away from each other while a pair of autologous leaflets are inserted therebetween. Once the leaflets are in the proper position between the leaflet engagement members 706, each pair of leaflet engagement members 706 can also apply sufficient compressive force to the leaflets so that the leaflets remain between the leaflet engagement members 706. In the illustrated embodiment, the leaflet engagement members 706 can be configured to define small gaps between the curved segments 712 of adjacent members 706. In alternative embodiments, the curved segments 712 can define contact points that can contact corresponding contact points of adjacent members 706 when the members 706 are in their undeflected state.

[0275] Fig.41 Another embodiment of a support frame 800 is shown, which is shown in a flat or unrolled state for illustrative purposes. The support frame 800 includes an annular body 801 formed by a plurality of struts 802, and one or more leaflet engagement mechanisms 803. The leaflet engagement mechanisms 803 can include multiple pairs of semi-annular leaflet engagement members 804 disposed below the corresponding top ends 806 of the support frame. Each leaflet engagement member 804 in the illustrated embodiment includes a first fixed end portion 808 and a second fixed end portion 810 fixed to the corresponding strut 802, and a peak 812 formed by a portion of the leaflet engagement member 804 intermediate the two fixed end portions 808, 810. In the illustrated embodiment, the leaflet engagement member 804 can extend generally in the direction of the outflow end of the support frame 800 so that the first fixed end portion 808 is closer to the top end 806 than the peak 812. Fig.42 A support frame 800 is shown implanted in an aortic root 814 with native leaflets 816 of an aortic valve 818 captured between corresponding pairs of leaflet engagement members 804.

[0276] Fig.43 Another embodiment of a support stent 900 is shown that includes a plurality of struts 902 and a plurality of leaflet engagement mechanisms 903. The leaflet engagement mechanisms 903 can include clamping members 904 secured to distal tips 916 of struts 902 at the inflow end of the support stent 900. Fig.44Clamping members 904 are shown spaced apart from the support bracket 900. Each clamping member 904 includes two leg portions 906 secured to each other at a tip 908. Each leg portion 906 has a free end portion 910 that can be angled inwardly toward the other free end portion 910 as shown. Each clamping member 904 can be secured to the support frame 900 with a section of fabric cloth 912 extending around the tip 908 of the clamping member 904 and an adjacent distal tip 916 of the support frame 900 at the inflow end of the support frame. Sutures can be used to secure the cloth 912 in place around the clamping member 904 and the adjacent distal tip 916 of the support frame 900. As shown in FIG. Fig.43 and Fig.45 It can be seen that the two leg portions 906 of adjacent clamping members 904 are capable of extending toward each other for capturing a pair of native leaflets 914.

[0277] In some embodiments, the clamping member 904 can be formed separately from the support frame 900 and can be made of a metal wire having a diameter smaller than the diameter of the support column 902. For example, in some embodiments, the diameter of the clamping member 904 can be from about 0.010 inches to about 0.023 inches. Each leg portion 906 of the clamping member 904 can also have a length L ( 5 mm or more, for example). Fig.46 Thus, the clamping member 904 can be configured to exert an inward retaining force F on the aortic valve leaflets. in ,like Fig.45 and Fig.46 In some embodiments, the holding force F in can be about 3 N. The clamping member 904 can also have a removal force F required to remove or reposition the device 900 along the leaflet 914. R , and the buckling force F oriented axially relative to the support 902 B . Removal force F R and buckling force F B can be configured so that application of the required removal force Fr can result in a buckling force F B The force F is sufficient to cause the clamping member 904 to bend or flex, thereby reducing the risk of tearing the native valve leaflets 914 when the support frame 900 is repositioned or removed. R Can be about 6 N. In an alternative embodiment, the clamping member 904 can be integrally formed with the support frame 900 .

[0278] Fig.47Another embodiment of a support stent 1000 is shown that includes an annular body formed by a plurality of struts 1002. A leaflet engagement mechanism 1003 including a horseshoe-shaped leaflet engagement member 1006 is disposed below one or more selected poles 1004 of the support stent 1000, the leaflet engagement member 1006 being configured as a clip corresponding to each of the three commissure locations of the native aortic valve. Each of the leaflet engagement members 1006 can be configured to capture a corresponding pair of native leaflets at each commissure of the aorta. The leaflet engagement members 1006 and the support frame 1000 can be integrally manufactured or manufactured separately and subsequently assembled using any suitable method or combination such as welding, tying with sutures or threads, adhesives, mechanical fixation, etc. In this application, the phrases "integrally manufactured", "integrally formed", and "integrated with..." all refer to a construction that does not include any adhesive, fastener, or other device for fixing separately formed pieces of material to each other.

[0279] Fig.48 and Fig.49 A partial view of another embodiment of a support frame 1100 comprising an annular body formed by a plurality of struts 1102 is shown. The support frame 1100 can include one or more leaflet engagement mechanisms 1103, which include a pair of integrated leaflet engagement members 1104. The leaflet engagement members 1104 can be positioned below a selected top 1106 and can be configured to capture a corresponding pair of autologous leaflets. In the illustrated embodiment, each leaflet engagement member 1104 has a first end 1108 fixed to the strut 1102 and a second end 1110 fixed to the same strut 1102. Each leaflet engagement member 1104 can be spring biased to allow a pair of adjacent leaflet engagement members 1104 to deflect away from each other when a pair of autologous leaflets are inserted between the leaflet engagement members 1104. The leaflet engagement members 1104 can be configured to apply a force to the leaflets so that the leaflets remain between the leaflet engagement members 1104.

[0280] exist Fig.48 In an embodiment of the present invention, the curved leaflet engagement members 1104 can define contact points that contact corresponding contact points of adjacent members 1104 when the members 1104 are in their undeflected state. Alternatively, the members 1104 can be configured to define small gaps between the curved segments of adjacent members 1104, such as Fig.49 As shown. Depending on, for example, the desired degree of spring bias, member 1104 can also have a value greater than, equal to ( Fig.49 ) or less than ( Fig.48 )The diameter of the diameter of the pillar 1102.

[0281] Fig.50 and Fig.51A partial view of another embodiment of a support stent 1200 comprising an annular body formed by a plurality of struts 1202 is shown. Below one or more selected apexes 1204, the struts 1202 can be curved or otherwise shaped so that adjacent struts define a leaflet engagement mechanism 1203 having a narrow leaflet engagement region 1206 between the struts 1202. The leaflet engagement region 1206 can include a gap sized to clamp the native aortic valve leaflets. The struts 1202 can be spring biased to allow adjacent pairs of struts 1202 to deflect away from each other when a pair of native leaflets are inserted between the struts 1202, and cause the struts 1202 to apply sufficient force to the leaflets to keep the leaflets in place between the struts 1202. In some embodiments, the leaflet engagement region 1206 can include teeth or serrations 1208 configured to engage the native leaflets, thereby helping to keep the frame 1200 in place after implantation.

[0282] Fig.52 Another embodiment of a stent 1300 is shown that includes an annular body formed by a plurality of struts 1302. The support frame 1300 can include a leaflet engagement mechanism 1303 located below a selected apex 1304 and defined by the struts 1302. The struts 1302 can be separated by narrow leaflet engagement regions 1306. The leaflet engagement regions 1306 can include serrations 1308 that are configured to engage native leaflets when they are inserted between the struts 1302. In this way, the stent 1300 can remain in place after implantation.

[0283] refer to Figure 53 to Figure 55 , showing a ring-shaped body 1401 ( Fig.53 Another embodiment of a support frame 1400 (shown as flat in ). The support frame 1400 can include one or more leaflet engagement mechanisms 1403, which can include a pair of leaflet engagement members 1404 secured to corresponding struts 1402 below one or more apexes 1406 formed by the intersection of two adjacent struts 1402. Each leaflet engagement member 1404 can have a fixed end portion 1408 and a free end portion 1410, the fixed end portion 1408 being secured to the corresponding strut 1402. The leaflet engagement members 1404 can extend downwardly from near the apex 1406 at the outflow end of the support frame 1400 and toward each other, thereby defining a narrow leaflet engagement region 1405 before bending toward the struts 1402 near the inflow end of the frame 1400. As shown in FIG. Fig.54As best shown, in their normal unbiased (undeflected) state, the leaflet engagement members 1404 can be configured so that a small gap exists between the free end portions 1410 and the struts 1402. Thus, when the leaflets 1414 of the native valve are inserted therebetween, the leaflet engagement members 1404 can be deflected toward the adjacent struts 1402, such as Fig.55 As in the previously described embodiments, the struts 1402 and leaflet engagement members 1404 can be laser cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) so that the leaflet engagement members 1404 are integral with the support stent. Alternatively, the leaflet engagement members 1404 can be formed separately and welded to the struts 1402.

[0284] In the illustrated embodiment, the support frame 1400 can include a pair of leaflet engagement members 1404 located below each apex 1406 of the frame. This can make implantation of the support frame 1400 easier by reducing the amount that the frame 1400 must be rotated in order to align multiple pairs of leaflet engagement members with the commissures of the native valve. Alternatively, the support frame 1400 can have a pair of leaflet engagement members 1404 for each commissure of the native valve in which the support frame is to be implanted. Thus, similar to the above Fig.33 In an embodiment, when the support frame 1400 is intended for implantation at the aortic valve or the pulmonary valve, the support frame 1400 desirably has three pairs of angularly spaced leaflet engagement members 1404, wherein each pair is disposed below a tip 1406 that is disposed at the commissures of the native valve when the support frame 1400 is implanted. Similarly, if the support frame 1400 is configured for implantation at the native mitral valve, the support frame 1400 desirably can have two pairs of leaflet engagement members 1404. Although less desirable, in some embodiments, the number of pairs of leaflet engagement members 1404 can be less than the number of commissures of the native valve in which the support stent is to be implanted. Similar to the support stent 310, the support stent 1400 can also have retaining arms 1412 ( Fig.53 ) for releasably securing the support bracket 1400 to a delivery device (eg, delivery device 350).

[0285] Fig.56An improvement of a support stent 1400 having leaflet engagement members 1404 that overlap each other in their normal (undeflected) state is shown. In this way, the leaflet engagement members 1404 can be configured to retain the native valve leaflets 1414 by applying a preload force to the leaflets 1414 once the leaflets 1414 are captured between the leaflet engagement members 1404. In the illustrated embodiment, the overlapping regions of the leaflet engagement members 1404 are offset from a central axis 1416 extending through the tip 1406, and the corresponding fixed end portions 1408 of the leaf springs are vertically offset from each other. Alternatively, the corresponding leaflet engagement members 1404 can overlap symmetrically about the central axis 1416 of the stent, and the fixed end portions 1408 can be fixed to the corresponding struts 1402 at the same vertical position. In the illustrated embodiment, when the leaflet engagement members 1404 are in their undeflected state, the free end portions 1410 of the leaflet engagement members 1404 contact the struts 1402. Alternatively, depending on the degree of spring bias desired in the leaflet engagement member 1404 , the free end portion 1410 can be spaced apart from the strut 1402 such that a gap exists between the free end portion 1410 and the strut 1402 .

[0286] Fig.57 and Fig.58 Another improvement of the support frame 1400 is shown having a leaflet engagement member 1404 that includes serrations 1418 located in the leaflet engagement region 1405. The serrations 1418 can be defined by circular cutouts 1420 so that the serrations 1418 extend outwardly from the leaflet engagement member 1404 in a direction generally orthogonal to the surface of the leaflet engagement member 1404, as shown in FIG. Fig.57 The serrations 1418 can help retain the autologous leaflets between the leaflet engagement members 1404 after insertion. Alternatively, the leaflet engagement members 1404 can include angled cutouts 1422 so that the serrations 1418 are oriented generally in the direction of the outflow end of the support frame 1400, as shown. Fig.58 As shown. In this way, the serrations 1418 can allow for smooth insertion of the native leaflets between the leaflet engagement members 1404 (i.e., the orientation of the serrations 1418 can minimize damage to the leaflets caused by the serrations 1418 during insertion), while retaining the native leaflets between the leaflet engagement members 1404 after insertion. In further alternative embodiments, the leaflet engagement members 1404 can include surface roughness in the leaflet engagement region 1405 to increase retention of the native valve leaflets.

[0287] Fig.59A and Fig.59BAnother improvement of the support stent 1400 is shown, in which each pair of corresponding leaflet engagement members 1404 includes a protrusion 1424 and a corresponding cutout or notch 1426 configured to receive the protrusion 1424. In some embodiments, the leaflet engagement members 1404 can be spring biased to be in the open position ( Fig.59A ) and closed position ( Fig.59B ), in which the corresponding leaflet springs define a gap therebetween, and in which the recesses 1426 receive the corresponding protrusions 1424 of the leaflet engagement members 1404 in the closed position. In this way, when the leaflet engagement members 1404 are in the open position, the native valve leaflets inserted between the leaflet engagement members 1404 can be engaged and held between the protrusions 1424 and recesses 1426 of the corresponding leaflet engagement members 1404 when the leaflet engagement members 1404 are in the closed position.

[0288] Fig.60 A detailed view of another embodiment of a stent 1500 including an annular body formed by a plurality of struts 1502 is shown. Below the top 1504, the support frame 1500 can include a leaflet engagement mechanism 1503 in the form of a leaflet engagement portion 1505 defined by the struts 1502. The leaflet engagement portion 1505 can define a gap 1506 that is configured to engage and retain a native valve leaflet 1508 after the leaflet is inserted into the gap 1506. The leaflet engagement portion 1505 can include a cloth or fabric cover 1510 that surrounds the respective struts 1502 and extends over the top 1504. The fabric cover 1510 can be configured to engage the native leaflet 1508 when the leaflet is inserted into the gap 1506. The fabric cover 1510 can be configured to reduce wear and / or damage to the native leaflet, and to accommodate different leaflet thicknesses. The cloth or fabric is optionally included at any location where tissue damage or wear may occur in any embodiment of the support frame disclosed herein.

[0289] Fig.61A modification of a stent 1500 is shown having a leaflet engagement portion 1505 defining a first gap 1506 and a second gap 1514, wherein the first gap 1506 is narrower than the second gap 1514. The first gap 1506 can be defined by an increase in thickness of the corresponding strut 1502 in the area of ​​the first gap 1506, and can include serrations 1516 on the corresponding strut 1502. The first gap 1506 and serrations 1516 together can assist in retaining the autologous leaflet 1508 after the autologous leaflet is inserted into the leaflet engagement portion 1505. In some embodiments, the struts 1502 can have a uniform first thickness, except for a portion of the corresponding strut 1502 defining the first gap 1506, wherein the thickness of the struts 1502 can increase to a second thickness greater than the first thickness before returning to the first thickness in the area defining the second gap 1514. In an alternative embodiment, the struts 1502 can have a third thickness less than the first thickness in the area defining the second gap 1514, such as Fig.62 shown.

[0290] Fig.63 Another improvement of the stent 1500 is shown, in which the first gap 1506 has a tapered shape and the distance between the corresponding struts 1502 decreases from the inflow end of the first gap 1506 to the outflow end of the first gap 1506. The leaflet engagement portion 1505 can also include one or more protrusions or barbs 1518 located on the corresponding struts 1502 and extending into the first gap 1506 and or the second gap 1514. For example, as Fig.63 As shown, the leaflet engagement portion 1505 can include barbs 1518 located on the corresponding struts 1502 at the inflow end of the first gap 1506, and barbs 1518 located on the outflow end of the first gap 1506 and oriented generally in the direction of the second gap 1514. In this way, the support frame 1500 can be held in place after the autologous leaflets 1508 are inserted into the leaflet engagement portion 1505. In alternative embodiments, the leaflet engagement portion 1505 need not include barbs, or the barbs can be smooth protrusions rather than pointed protrusions.

[0291] In another alternative embodiment of the support frame 1500, the struts 1502 can define a single gap 1506 in the leaflet engagement portion 1505, such as Fig.64 The gap 1506 can include cutouts or serrations 1516 extending from the distal end to the proximal end of the gap 1506 or any suitable length therebetween.

[0292] Fig.654202. The support frame 4200 can include a leaflet engagement mechanism 4203 that includes a pair of toothed wheels or gears 4204 rotationally secured to a leaflet engagement portion 4206 of the frame 4200 below a tip 4212 defined by the intersection of the struts 4202. In the illustrated embodiment, each wheel 4204 can have an easy rotation direction (indicated by arrows 4208) that permits easy entry of the native leaflet 4210 into the leaflet engagement portion 4206 of the support frame 4200. It is difficult to rotate each wheel 4204 in the opposite direction, thereby tending to keep the leaflet 4210 engaged in the leaflet engagement portion 4206. Some embodiments of the wheels 4204 can include a soft or elastomeric material that contacts the leaflet 4210, thereby reducing wear or damage thereto. Some embodiments can include only one wheel 4204 which can engage the leaflets 4210 between the wheel 4204 and the struts 4202 of the leaflet engagement portion 4206 .

[0293] FIG. 66A to FIG. 66D 16 is a detailed view of another embodiment of a support frame 1600 including an annular body formed by a plurality of struts 1602. The frame 1600 can include one or more active leaflet clamping mechanisms 1604, including in an open position ( Fig.66A ) and closed position ( Fig.66B ) are two clamping arms 1606 movable between them. In some embodiments, the clamping arms 1606 can be biased toward a closed position. The clamping arms 1606 can include respective proximal portions 1608, middle portions 1610, and distal leaflet engagement portions 1612. In the illustrated embodiment, the proximal portion 1608 includes a hole or eyelet 1614 configured to receive a wire or a flexible fork (e.g., the flexible fork 141 of the delivery system 350). In this way, when the clamping arms 1606 are mounted on the delivery device prior to implantation, they can be maintained in an open position, as further described below.

[0294] The middle portion 1610 can include a connection member 1616 coupled to the strut 1602 of the stent 1600. In the illustrated embodiment, the connection member 1616 can be coupled to the strut on the top end 1618 of the strut 1602 or to the strut adjacent to the top end 1618. However, the connection member 1616 can be coupled to the strut 1602 at any suitable location along the length of the strut. The connection member 1616 can act as a fulcrum about which the clamp arm 1606 pivots when moving between the open and closed positions.

[0295] The leaflet engagement portion 1612 can be configured to engage the native leaflet 1622 when the clamp arm 1606 is in the closed position. Fig.66C and Fig.66D In the illustrated embodiment, the leaflet engagement portion 1612 includes a protrusion 1620 that is configured to engage and retain the native leaflet 1622 between the clamping arms 1606. Alternatively, the leaflet engagement portion 1612 can include any suitable type of surface treatment to help retain the leaflet 1622 between the clamping arms 1606, such as cuts, serrations, surface roughness, etc. In further alternative embodiments, the leaflet engagement portion 1612 may not include any surface treatment.

[0296] The support 1602 and one or more leaflet engagement mechanisms 1604 can be laser cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) such that the leaflet engagement mechanism 1604 is integral with the support stent. In other embodiments, the leaflet engagement mechanism 1604 can be formed separately and welded or otherwise coupled to the support 1602. In some embodiments, the leaflet engagement mechanism 1604 can be located on the interior of the stent valve annulus. Alternatively, the leaflet engagement mechanism 1604 can be located on the exterior of the stent valve.

[0297] After manufacturing the stent, the clamp arms 1606 can be arranged on the respective sides of the pillars 1602, and the connecting members coupled to the pillars, such as Fig.66A The clamping arm 1606 can then be shaped so that the clamping arm is biased toward the closed position, as shown. Fig.66B Prior to insertion into a patient, the flexible fork 141 of the delivery system 350 can be threaded through the aperture 1626 of the retaining arm 1624 and through the hole 1614 of the clamping arm, so that the clamping arm 1606 is held in the open position, as shown. Fig.66C After the stent is positioned on and around the valve leaflet 1622, the flexible prongs 141 can be retracted through the holes 1614, thereby releasing the clamping arms 1606. The clamping arms 1606 can then be moved to a closed position, thereby capturing the leaflet 1622 between the corresponding leaflet engagement portions 1612 of the clamping arms, as shown. Fig.66D The flexible prongs 141 can then be retracted through the apertures 1626 of the retaining arms 1624, and the delivery system 350 can be withdrawn, leaving the stent secured to the leaflets 1622 in the native valve.

[0298] Fig.67A , Fig.67B , Fig.68A and Fig.68BAnother embodiment of a support frame 1700 is shown including an annular body 1701 formed by a plurality of struts 1702. The support frame 1700 can include one or more active leaflet engagement mechanisms 1704 including elongated members 1706 configured to engage in an open position ( Fig.67A ) and closed position ( Fig.67B ). In the illustrated embodiment, the elongated member 1706 can include a proximal portion 1708 having an eyelet or hole 1710, and a distal portion 1712 coupled to a tip 1714 of the stent and / or a base of the retaining arm 1716. In the illustrated embodiment, the elongated member 1706 can be disposed in an opening 1726 defined by the retaining arm 1716 when the elongated member 1706 is in the open position, and can be moved out of the opening 1726 when it is moved into the closed position.

[0299] In some embodiments, the proximal portion 1708 of the elongated member 1706 can be bent radially inward (ie, in a direction toward the center of the annulus), such as Fig.67B Alternatively, the proximal portion 1708 can be straight or otherwise conform to the vertical profile of the retaining arm 1714, such as Fig.67A The distal portion 1712 can include a spring portion 1718, which can be shaped to bias the elongated member 1706 toward the closed position, as shown. Fig.67B shown.

[0300] The leaflet engagement mechanisms 1704 can be integrally formed (e.g., by laser cutting, machining, or forming) with the stent 1700 formed from a single piece of material (e.g., a metal piece). Alternatively, the leaflet engagement mechanisms 1704 can be formed separately and welded or otherwise coupled to the stent 1700. When the support frame 1700 is intended for implantation at the aortic valve or pulmonary valve, the support stent 1700 desirably has three angularly spaced leaflet engagement mechanisms 1704, wherein each mechanism is disposed at the commissure of the native valve when the support stent 1700 is implanted, such as Fig.68A and Fig.68B Similarly, if the support stent is configured for implantation at the native mitral valve, the support stent desirably has two leaflet engagement mechanisms 1704 .

[0301] Prior to implantation, the elongated member 1706 can be shaped so that it is biased toward the closed position, as described above. The flexible prongs 141 of the delivery system 350 can be threaded through the apertures 1720 of the retaining arms 1716 and through the holes 1710 of the elongated member 1706 to retain the elongated member in the open position, as described above. Fig.68A Reference Fig.68BAfter stenting the valve leaflets 1722 (shown in phantom), the forks 141 can be retracted through the holes 1710, thereby releasing the elongated members 1706. The elongated members 1706 can then be moved to a closed position, thereby engaging and retaining the leaflets 1722 between the struts 1702, as shown. Fig.66D The prongs 141 can then be retracted through the apertures 1720 of the retaining arms 1716 and the delivery system 350 can be withdrawn, leaving the stent secured to the leaflets 1722 in the native valve.

[0302] Fig.69A and Fig.69B A detailed view of another embodiment of a support frame 1800 including an annular body formed by a plurality of struts 1802 is shown. The support frame 1800 can include one or more active leaflet engagement mechanisms 1804, which include a pair of leaflet engagement members 1806 fixed to respective struts 1802. The leaflet engagement members can be in an open position (e.g., Fig.69B ) and the closed position (as shown Fig.69A 1802). Each leaflet engagement member 1806 can have a fixed end portion 1808 and a free end portion 1810 fixed to a corresponding pillar 1802. The leaflet engagement members 1806 can extend distally from the pillars 1802 toward the inflow end of the frame 1800 and toward each other so that the free end portions 1810 are substantially consistent when the leaflet engagement members 1806 are in a closed position. In the illustrated embodiment, the fixed end portions 1808 of the leaflet engagement members 1806 are fixed to the pillars 1802 at the midpoint of the pillars. However, in alternative embodiments, the leaflet engagement members 1806 can be fixed to the pillars 1802 at any suitable position. In the illustrated embodiment, the free end portion 1810 of each leaflet engagement member 1806 includes a foot 1814, which can be guided toward a received leaflet (not shown), which can help to retain the leaflets between the leaflet engagement members 1806. In alternative embodiments, the free end portion 1810 can include other leaflet engagement features, such as barbs, serrations, notches, hooks, surface roughness, and the like.

[0303] The open position and the closed position can correspond to a radially collapsed state and a radially expanded state, respectively, of the frame 1800. For example, when the frame 1800 is in a radially collapsed state, such as when loaded or partially deployed from a delivery catheter, the struts 1802 can be displaced circumferentially toward each other, such as Fig.69BAs shown. Circumferential displacement of the struts 1802 toward each other can cause the free end portions 1810 of the leaflet engagement members 1806 to be circumferentially displaced away from each other, thereby defining a leaflet engagement region 1812 between the free end portions 1810 of the corresponding leaflet engagement members 1806. During implantation, the frame 1800 can be partially deployed from the delivery catheter and positioned so that the native valve leaflets (not shown) are located in the leaflet engagement regions 1812 of the corresponding leaflet engagement mechanisms 1804. The frame 1800 can then be fully deployed from the delivery catheter, causing the frame 1800 to expand to its functional size and causing the leaflet engagement members 1806 to be circumferentially displaced to a closed position (causing the end portions 1810 to move toward each other, Fig.69A ), thereby engaging the leaflets between the free end portions 1810 of the member 1806 at or near their commissures.

[0304] Fig.70A and Fig.70B A perspective view of another embodiment of a support frame 1900 is shown including an annular body 1901 formed by a plurality of struts 1902. The frame 1900 can include one or more leaflet engagement mechanisms 1903, which include multiple pairs of leaflet engagement members 1904 extending circumferentially between alternating first tips 1906a and second tips 1906b. Each leaflet engagement member 1904 can include a fixed end portion 1908 coupled to a first tip 1906a, a middle portion 1910 coupled to an adjacent second tip 1906b or to a strut 1902 directly below the second tip 1906b, and a free end portion 1912 disposed below the second tip 1906b. The multiple pairs of leaflet engagement members 1904 can be configured to be in open positions (i.e., partially radially collapsed) and fully deployed configurations corresponding to the stent 1900, respectively. Fig.70B ) and closed position ( Fig.70A )

[0305] In the illustrated embodiment, the middle portion 1910 of the leaflet engagement member 1904 can include approximately equidistant peaks 1918 located between the first top 1906a and the second top 1906b. The peaks 1918, together with the relatively long length of the middle portion 1910, can provide the leaflet engagement member 1904 with some elasticity or flexibility consistent with the curved contact area, which can reduce the risk of damage to the leaflets. The free end portions 1912 of each corresponding pair of leaflet engagement members 1904 can define a leaflet engagement area or gap 1914, which is designed to engage and retain the leaflets of the native heart valve (not shown). In the illustrated embodiment, the free end portions 1912 of the leaflet engagement member 1904 can define a curved leaflet contact area 1920, which can reduce the risk of damage to the leaflets. In some embodiments, the leaflet contact area 1920 can include a surface treatment, such as a protrusion, a cutout, a surface roughness, etc., to help retain the leaflets between the leaflet engagement members.

[0306] In the illustrated embodiment, the first tip 1906a can include a retaining arm 1916. Thus, when the stent is deployed from the delivery catheter 1922, the second tip 1906b can first emerge from the delivery catheter 1922, while the retaining arm 1916 of the first tip 1906a remains within the lumen of the delivery catheter 1922, as shown. Fig.70B As shown. This can cause the retaining arms 1916 and the associated first top 1906a to flex radially inward, thereby pulling the struts 1902 of the second top 1906b apart. This can cause the free end portions 1912 of the leaflet engagement members 1904 to be pulled into an open position, thereby allowing the leaflet to be inserted into the leaflet engagement region 1914. Once positioned around the leaflet, the retaining arms 1916 can be fully deployed from the delivery catheter 1922, thereby allowing the frame 1900 to expand to its functional size and causing the leaflet engagement members 1904 to move into a closed position, thereby engaging and retaining the autologous leaflet. In some embodiments, the curved free end portions 1912 of the leaflet engagement members 1904 can be configured to contact the leaflets in both the open and closed configurations, which can permit the leaflet engagement members 1904 to be rolled into position when the support frame is expanded to the closed configuration, thereby reducing the risk of damage to the autologous leaflets.

[0307] The leaflet engagement member 1904 can be integrally formed with the stent 1900, or can be separately formed and secured to the stent by, for example, welding, brazing, adhesives, etc. In the illustrated embodiment, the fixed end portion 1908 is integrally formed with the first apex 1906a, and the intermediate portion 1910 is welded to the radially outwardly facing surface of the struts 1902 of the second apex 1906b. In alternative embodiments, both the fixed end portion 1908 and the intermediate portion 1910 can be integrally formed with the respective first apex 1906a and second apex 1906b, or the fixed end portion 1908 and the intermediate portion 1910 can be separately formed and secured to the respective apex 1906a, 1906b as described above.

[0308] Fig.71 , Fig.72A , Fig.72B and Fig.73 Another embodiment of a support frame 2000 is shown that includes an annular body 2001 having a plurality of leaflet engagement mechanisms configured as a frame subunit 2002 formed by a corresponding number of branch members 2004. The frame subunit 2002 can include an actuator portion 2006 and a leaflet engagement portion 2008. The leaflet engagement portion 2008 can include a plurality of leaflet engagement mechanisms that are configured as a frame subunit 2002 formed by a corresponding number of branch members 2004. The frame subunit 2002 can include an actuator portion 2006 and a leaflet engagement portion 2008. The leaflet engagement portion 2008 can include a plurality of leaflet engagement mechanisms that are configured as a frame subunit 2002 formed by a corresponding number of branch members 2004. Fig.72A ) and closed position ( Fig.71 and Fig.72B ) are two leaflet clamping subunits 2010 movable between them. In the illustrated embodiment, the frame 2000 includes three frame subunits 2002 formed by three corresponding branch members 2004 and connected to each other by connecting members 2012.

[0309] refer to Fig.71 2008, the actuator portion 2006 can include a peak 2014 and a valley 2016. The peak 2014 can be formed by the intersection of the first branch 2018 and the second branch 2020 of the branch member 2004 at the proximal end of the actuator portion 2006. The first branch 2018 and the second branch 2020 of the branch member 2004 can be arcuate, and can be further branched into a third branch 2022 and a fourth branch 2024, and a fifth branch 2026 and a sixth branch 2028. The valley 2016 can be defined by the meeting point of the fourth branch 2024 and the fifth branch 2026 of the branch member 2004 near the proximal end of the leaflet joint portion 2008. In the illustrated embodiment, the fourth branch 2024 and the fifth branch 2026 meet toward each other, but do not intersect to form a single integral member. However, in an alternative embodiment, if desired, the fourth branch 2024 and the fifth branch 2026 can intersect to form an integral member. In the illustrated embodiment, the peak 2010 can also include a retaining arm 2011 .

[0310] The leaflet clamping subunits 2010 can each have a peak 2030 and a valley 2032. The peak 2030 can be formed by respective proximal intersections of the third branch 2022 and the fourth branch 2024, and the fifth branch 2026 and the sixth branch 2028, respectively, of the branch member 2002. Similarly, the valley 2032 can be formed by respective distal intersections of the third branch 2022 and the fourth branch 2024, and the fifth branch 2026 and the sixth branch 2028, respectively. The respective peaks 2030 of the leaflet clamping subunits 2010 can be angled away from each other so that the leaflet clamping subunits 2010 are biased toward a closed position when the frame is in a fully expanded configuration. In this way, the leaflet clamping subunits 2010 can be configured to engage and hold the native leaflets 2038 between the respective leaflet clamping subunits 2010 when the frame 2000 is deployed in the native valve 2034, as shown in FIG. Fig.73 The fourth branch 2024 and the fifth branch 2026 can also be interconnected by a spring member 2036, which can help bias the leaflet clamping subunit 2010 toward the closed position.

[0311] The support frame 2000 can be configured so that when deployed from the distal end portion of a delivery catheter 2040 with the corresponding frame subunit 2002 within the catheter and the actuator portion 2006 of the leaflet clamping subunit 2010 outside the catheter, radial compression of the actuator portion 2006 can actuate or lever-move the leaflet clamping subunit 2010 into an open position, such as Fig.72A As shown in FIG. 20, the user can position the support frame 2000 over the commissures 2042 of the native valve leaflets 2038 so that the leaflets are located between the corresponding leaflet clamping subunits 2010 of the leaflet engagement portion 2008. When the support frame 2000 is more fully deployed, the radial compression of the actuator portion 2006 can be released, causing the leaflet clamping subunits 2010 to close, capturing the leaflets 2038 of the native valve 2034 therebetween, as shown in FIG. Fig.73 Retracting the support frame 2000 partially back into the catheter 2040 can reopen the leaflet clamping subunit 2010 by applying radial compression to the actuator portion 2006, thereby permitting the user to reposition the device. Fig.72B is an illustration of a support frame partially deployed from a delivery catheter 2040 with a leaflet clamping subunit 2010 intermediate between an open and closed position. Fig.73 is a top view of the support frame fully deployed in the aortic valve 2034.

[0312] The branch members 2004 of the support frame can be laser cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) such that the frame subunit 2002 is integral with the support bracket. In other embodiments, the individual branches of the branch members 2004 can be formed separately and welded or otherwise coupled together to form the frame subunit 2002. In other alternative embodiments, the respective frame subunits can be integrally formed and then joined together by, for example, welding, brazing, adhesives, etc.

[0313] Fig.74A and Fig.74B Another embodiment of a support frame 2100 is shown comprising an annular body 2101 including a plurality of leaflet engagement mechanisms configured as a frame subunit 2102. The frame subunit 2102 can be formed by a plurality of first frame members 2104 and second frame members 2106 configured as retaining arms. Fig.74A is a side elevation view of the flat layout pattern of the support frame 2100, and Fig.74B The support frame 2100 is shown in a fully expanded configuration. The frame subunit 2102 can include an actuator portion 2108 and a leaflet engagement portion 2110. The leaflet engagement portion 2110 can include two leaflet clamping subunits 2112 movable between an open position and a closed position by actuation of the actuator portion 2108, similar to Fig.71 In the illustrated embodiment, the frame 2100 includes three frame subunits 2102, although the frame can include any suitable number of frame subunits depending on the valve structure in which the frame is to be implanted.

[0314] Each of the first frame members 2104 can include a first inner branch 2114 and a second inner branch 2116, which can define an actuator portion 2108 of a corresponding frame subunit 2102, as described further below. Each of the second frame members 2106 can include a first outer branch 2118 and a second outer branch 2120, which can define a corresponding boundary of the leaflet engagement portion 2110. In the illustrated embodiment, the frame subunit 2102 can be bounded by the corresponding second frame member 2106.

[0315] The actuator portion 2108 can include a peak 2122 and a valley 2124. The peak 2122 can be formed by the intersection of the first inner branch 2114 and the second inner branch 2116 of the first frame 2104 at the proximal end of the first frame member 2104. The first inner branch 2114 and the second inner branch 2116 of the first frame member 2104 can be symmetrically arcuate and can intersect each other at the intersection 2126 located at the distal end of the actuator portion 2108, thereby defining the valley 2124 of the actuator portion 2108. In the illustrated embodiment, the intersection 2126 can act as a lever, thereby causing the leaflet clamping subunit 2112 to move to the open position when radial compression is applied to the first inner branch 2114 and the second inner branch 2116 of the actuator portion 2106. In alternative embodiments, the first inner branch 2114 and the second inner branch 2116 of the first frame member 2104 need not intersect.

[0316] With reference to the leaflet engagement portion 2110, the first inner branch 2114 and the second inner branch 2116 of the first frame member 2104 can continue to extend distally from the intersection 2126 to the distal end of the leaflet engagement portion 2110, where they can intersect with the first outer branch 2118 and the second outer branch 2120 of the second frame member 2106 to form a valley 2128 of the corresponding leaflet clamping subunit 2110. The first inner branch 2114 and the second outer branch 2120, as well as the second inner branch 2116 and the first outer branch 2118 can be interconnected by corresponding interconnecting members 2130. The interconnecting members 2130 can define peaks 2132, which can be angled away from each other. In this way, when the stent 2100 is in a fully expanded configuration, the interconnecting members 2130 can act as a spring that biases the leaflet clamping subunit 2112 toward the closed position. In this way, the leaflet clamping subunits 2112 can be configured to engage and hold the native valve between the corresponding leaflet clamping subunits when the frame is deployed within the native valve.

[0317] The support frame 2100 can be configured so that when partially deployed from the end of a catheter with the actuator portion 2108 having the corresponding frame subunit 2102 within the catheter and the leaflet clamping subunit 2112 outside the catheter, radial compression of the actuator portion 2108 can actuate or lever-move the leaflet clamping subunit 2112 into an open position, similar to Fig.71In this way, the user can position the support frame 2100 over the commissures of the native valve leaflets so that the leaflets are located between the corresponding leaflet clamping subunits 2112 of the leaflet engagement portion 2110. When the support frame 2100 is more fully deployed, the radial compression of the actuator portion 2108 can be released, causing the leaflet clamping subunits 2112 to move to a closed position, capturing the leaflets of the native valve therebetween. Retracting the support frame 2100 partially back into the catheter can reopen the leaflet clamping subunits 2112 by reapplying radial compression to the actuator portion 2108, thereby permitting the user to reposition the device.

[0318] The first frame member 2104 and the second frame member 2106 of the support frame 2100 can be cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) using a laser so that the frame subunit 2102 is integral with the support bracket. In other embodiments, the branches of the first frame member 2104 and the second frame member 2106 can be formed separately and welded or otherwise coupled together to form the frame subunit 2102.

[0319] Fig.75A and Fig.75B Another embodiment of a support frame 2200 is shown that includes an annular body 2201 that includes a plurality of leaflet engagement mechanisms configured as frame subunits 2202. The frame subunits 2202 can be formed by a plurality of frame members 2204 configured as retaining arms, similar to Fig.74A and Fig.74B Embodiment of the invention. Fig.75A is a side elevation view of the flat layout pattern of the support frame 2200, and Fig.75B The support frame 2200 is shown in a fully expanded configuration. The frame subunit 2202 can include an actuator portion 2206 and a leaflet engagement portion 2208. The leaflet engagement portion 2208 can include two leaflet clamping subunits 2210, 2211 movable between an open position and a closed position by actuation of the actuator portion 2206, similar to Fig.71 In the illustrated embodiment, the frame 2200 includes three frame subunits 2202, however the frame can include any suitable number of frame subunits depending on the valve structure in which the frame is to be implanted.

[0320] Each of the frame members 2204 can include a first branch 2212 and a second branch 2214, which can define the actuator portion 2206 of the corresponding frame subunit 2202, as further described below. Each corresponding first branch 2212 can be further divided into a third branch 2216 and a fourth branch 2218, which can define the corresponding boundaries of the leaflet clamping subunits 2210, 2211. Similarly, each corresponding second branch 2214 can be further divided into a fifth branch 2220 and a sixth branch 2222.

[0321] Referring to the frame subunit 2202, generally the actuator portion 2206 can include a peak 2224 and two valleys 2226. The peak 2224 can be formed by the intersection of the first branch 2212 and the second branch 2214 of the frame member 2204 at the proximal end of the frame member 2204. The valley 2226 can be defined by the fourth branch 2218 and the fifth branch 2220, and the interconnecting member 2228 that can extend between the fourth branch 2218 and the fifth branch 2220. In the illustrated embodiment, the second branch 2214 can have an actuation portion 2232 that extends laterally relative to the longitudinal axis of the support frame 2200. In this way, radial compression of the actuator portion 2206, particularly the radial compression of the second branch 2214, can cause the leaflet clamping subunits 2210, 2211 to move to the open position.

[0322] Referring to the leaflet engagement portion 2208, the third branch 2216 and the fourth branch 2218 of the frame member 2204 can extend from the distal end of the first branch 2212 to the distal end of the leaflet engagement portion 2208, where they can intersect the sixth branch 2222 and the fifth branch 2220, respectively. In this way, the third branch 2216 and the sixth branch 2222 of the frame member 2204 can define a valley 2235 of the leaflet clamping subunit 2210, and the fourth branch 2218 and the fifth branch 2220 can define a valley 2234 of the leaflet clamping subunit 2211. The sixth branch 2222 and the third branch 2216 can also be interconnected by an interconnecting member 2229 similar to the interconnecting member 2228. The interconnecting members 2228, 2229 can include central peaks 2230, 2231, respectively, and can be angled away from each other. In this way, the interconnecting members 2228, 2229 can act as springs to bias the leaflet clamping subunits 2210, 2211 toward the closed position when the stent 2200 is in the fully expanded configuration. In this way, the leaflet clamping subunits 2210, 2211 can be configured to engage and hold the native leaflets between the corresponding leaflet clamping subunits when the frame is deployed in the native valve.

[0323] The support frame 2200 can be configured so that when deployed from the distal portion of a catheter with the corresponding frame subunits 2202 within the catheter and the actuator portion 2206 of the leaflet clamping subunits 2210, 2211 outside the catheter, radial compression of the actuator portion 2206 can actuate or lever-move the leaflet clamping subunits 2210, 2211 to an open position, similar to Fig.71 In this way, the user can position the support frame over the commissures of the native valve leaflets so that the leaflets are located between the corresponding leaflet clamping subunits 2210, 2211 of the leaflet engagement portion 2208. When the support frame 2200 is more fully deployed, the radial compression of the actuator portion 2206 can be released, causing the leaflet clamping subunits 2210, 2211 to move to a closed position, capturing the leaflets of the native valve therebetween. Retracting the support frame 2200 partially back into the catheter can reopen the leaflet clamping subunits 2210, 2211 by reapplying radial compression to the actuator portion 2206, thereby permitting the user to reposition the device.

[0324] Fig.76A and Fig.76B Another embodiment of a support frame 2300 is shown that includes an annular body including a plurality of leaflet engagement mechanisms configured as frame subunits 2302. The plurality of frame subunits 2302 can be formed by a corresponding number of branch members 2304, similar to Fig.71 The frame subunit 2302 can include an actuator portion 2306 and a leaflet engagement portion 2308. The leaflet engagement portion 2308 can include a portion that is actuated by the actuator portion 2306 to open the leaflet engagement portion 2308. Fig.76B ) and closed position ( Fig.76A ) are two leaflet clamping subunits 2310 movable between them. In the illustrated embodiment, the frame 2300 includes three frame subunits 2302 formed by three corresponding branch members 2304 and connected to each other by connecting members 2312.

[0325] Referring to the frame subunit 2302, generally the actuator portion 2306 can include a peak 2314 and a valley 2316. The peak 2314 can be formed by the intersection of the first branch 2318 and the second branch 2320 of the branch member 2004 at the proximal end of the actuator portion 2306. The first branch 2318 and the second branch 2320 of the branch member 2304 can be angled and can further branch into a third branch 2322 and a fourth branch 2324, and a fifth branch 2326 and a sixth branch 2328, respectively. In the illustrated embodiment, the third branch 2322, the fourth branch 2324, the fifth branch 2326, and the sixth branch 2328 are thicker than the first branch 2318 and the second branch 2320 from which they originate. In this way, when the support frame is in the open configuration, the first branch 2318 and the second branch 2320 can be configured to deform to a greater extent than the leaflet clamping subunit 2310. However, in an alternative embodiment, all branches of the branch member 2304 can have the same thickness.

[0326] The valley 2316 can be defined by the junction of the fourth branch 2324 and the fifth branch 2326 of the branch member 2304 near the proximal end of the leaflet engagement portion 2308, wherein the fourth branch 2324 and the fifth branch 2326 can be interconnected by the spring member 2334. In the illustrated embodiment, the fourth branch 2324 and the fifth branch 2326 meet, but do not intersect to form a single integral member. However, in an alternative embodiment, if desired, the fourth branch 2324 and the fifth branch 2326 can intersect to form an integral member. In the illustrated embodiment, the peak 2314 can also include a retaining arm 2311.

[0327] The leaflet clamping subunits 2310 can each have a peak 2330 and a valley 2332. The peak 2330 can be formed by the respective proximal intersections of the third branch 2322 and the fourth branch 2324, and the fifth branch 2326 and the sixth branch 2328 of the branch member 2302, respectively. Similarly, the valley 2332 can be formed by the respective distal intersections of the third branch 2322 and the fourth branch 2324, and the fifth branch 2326 and the sixth branch 2328, respectively. The respective peaks 2330 of the leaflet clamping subunits 2310 can be angled away from each other so that the leaflet clamping subunits are biased toward the closed position when the frame is in the fully expanded configuration. In this way, the leaflet clamping subunits 2310 can be configured to engage and hold the native leaflets between the respective leaflet clamping subunits 2310 when the frame 2300 is deployed in the native valve. As noted above, the fourth branch 2324 and the fifth branch 2326 can also be interconnected by a spring member 2334, which can help bias the leaflet clamping subunit 2310 toward the closed position.

[0328] The support frame 2300 can be configured so that when deployed from the distal portion of a catheter with the corresponding frame subunit 2302 within the catheter and the actuator portion 2306 of the leaflet clamping subunit 2310 outside the catheter, radial compression of the actuator portion 2306 can actuate or lever-move the leaflet clamping subunit 2310 into an open position ( Fig.76B ), as above Fig.71 Thus, the user can position the support frame 2300 on the commissures of the native valve so that the leaflets are located between the corresponding leaflet clamping subunits 2310 of the leaflet engagement portion 2308. When the support frame 2300 is more fully deployed, the radial compression of the actuator portion 2306 can be released, causing the leaflet clamping subunits 2310 to close ( Fig.76A ), capturing the leaflets of the native valve therebetween. Retracting the support frame portion back into the catheter can reopen the leaflet-holding subunit 2310 by reapplying radial compression to the actuator portion 2306, thereby permitting the user to reposition the device.

[0329] The branch members 2304 of the support frame can be laser cut (or otherwise machined or formed) from a single piece of material (e.g., a tubular metal piece) so that the frame subunit 2302 is integral with the support bracket. In other embodiments, the individual branches of the branch members 2304 can be formed separately and welded or otherwise coupled together to form the frame subunit 2302. In further alternative embodiments, the respective frame subunits can be integrally formed and then joined together by, for example, welding, brazing, adhesives, etc.

[0330] Fig.77A and Fig.77B The annular body 2401 ( Fig.77B ), which can include a plurality of apexes 2404 formed by the intersection of two adjacent struts 2402. The support frame can also include one or more leaflet engagement mechanisms 2406, which can include a first pair 2408 of struts 2402 and a second pair 2410 of struts 2402 extending distally from respective apexes 2404. The struts 2402 of each respective pair 2408, 2410 can be angled away from one another such that the pair 2408, 2410 of struts 2402 define a leaflet capture region 2412 therebetween. The pair 2408, 2410 of struts 2402 of each leaflet engagement portion 2406 can also be angled away from one another such that the leaflet capture region 2412 defined therebetween narrows toward the proximal end of the support frame 2400 before terminating at the respective apexes 2404.

[0331] For example, in Fig.77A and Fig.77BIn the illustrated embodiment, the first pair 2408 of struts 2402 can be angled so that the struts 2402 extend radially inward from the respective tops 2404. Similarly, the second pair 2410 of struts 2402 can be angled so that the struts 2402 extend radially outward from the respective tops 2404. In this way, the leaflet engagement portion 2406 can slide over the native leaflets of the aorta like a paper clip. In some embodiments, the distal portions of the first pair 2408 and the second pair 2410 of struts 2402 can include a surface treatment, such as threads, grooves, surface roughness, etc., to help retain the native leaflets 2414 after implantation.

[0332] exist Fig.77C In the illustrated alternative embodiment, the leaflet engagement mechanism 2406 can be oriented at a right angle to the annular body 2401. In this way, the leaflet engagement mechanism 2406 can slide over the commissures 2418 formed by the native leaflets 2414 of the aorta 2420. In this way, the support frame 2400 can reduce the valve orifice area of ​​the aorta 2420 by limiting the extent to which the native leaflets 2414 are allowed to open.

[0333] Figures 78 to 89B Another embodiment of a stent 2500 is shown that includes an annular body 2501 formed by a plurality of struts 2502. The stent 2500 can include one or more active leaflet engagement mechanisms 2504 located on three corresponding apexes 2506 formed by the intersection of two adjacent struts 2502. The leaflet engagement mechanism 2504 can include a leaflet clamp 2508 having two clamping arms 2510 slidably disposed within an annular restriction 2512. When the leaflet clamp 2508 is pulled distally and proximally, respectively, through the annular restriction 2512, the clamping arms 2510 of the leaflet clamp 2508 can be in an open position (see, e.g., Fig.78 ) and closed position (see e.g. Fig.89A ). In this way, the leaflet engagement mechanism 2504 can allow the user to position the support frame 2500 in a first step and clamp the leaflets of the native valve in a second step, thereby providing improved control over both the positioning and clamping forces. The leaflet engagement mechanism 2504 can be disposed on the interior of the support frame 2500, such as Fig.78 As shown, or arranged on the outside of the support frame, such as Fig.79 shown.

[0334] refer to Fig.80, the leaflet clip 2508 can include a proximal hairpin portion 2514 formed by parallel segments of the clamp arms 2510, a mid-portion 2516 in which the clamp arms 2510 branch, and a leaflet engagement portion 2518, with the distal portions 2520 of the respective clamp arms 2510 oriented toward each other at the leaflet engagement portion 2518. In some embodiments, the hairpin portions 2514 of the leaflet clip 2508 can extend over the respective apexes 2506 of the stent so that proximal movement of the leaflet clip 2508 through the annular restriction 2512 can cause the annular restriction 2512 to apply a force to the clamp arms 2510. Applying a force to the clamp arms 2510 through the annular restriction 2512 can cause the distal portions 2520 of the clamp arms 2510 to move toward each other. The distance between the respective end portions 2520 of the clamping arms 2510 and the resultant force applied to the native leaflet therebetween can be controlled by properly vertically positioning the leaflet clamp 2508 within the annular restriction 2512.

[0335] In some embodiments, the leaflet clip 2508 can be configured to match the geometric profile of the struts 2502 of the support frame 2500 so that the potential for the leaflet clip 2508 to interfere with the placement of the stent is reduced. For example, the clamp arm 2510 can define an angle θ between the hairpin portion 2514 and the middle portion 2516. The angle θ can be configured so that the bifurcated portion of the clamp arm 2510 approximates the profile of the struts 2502 of the support frame 2500. Similarly, the end portion 2520 of the clamp arm 2510 can be oriented at an angle α to the bifurcated portion of the clamp arm 2510 of the middle portion 2516. The end portion 2520 of the clamp arm 2501 can also have a length L. The angle α and length L of the end portion 2520 can be selected to reduce the tendency of the leaflet clip 2508 to interfere with the placement of the stent 2500 during implantation, while allowing the end portion 2520 to engage and retain the native leaflet. In some embodiments, angle θ can be from about 130 degrees to about 170 degrees. In some embodiments, angle θ can be about 147 degrees. In some embodiments, angle α can be from about 45 degrees to about 60 degrees.

[0336] In some embodiments, the clamp arms 2510 of the leaflet clamp 2508 can have a rectangular cross-sectional shape. This can increase the torsional stiffness of the clamp arms 2510, thereby reducing the tendency of the end portions 2520 to rotate inwardly or outwardly when the clamp arms are urged together by the annular restraint 2512. In alternative embodiments, the clamp arms 2510 can have a circular cross-sectional shape, or any other suitable cross-sectional shape.

[0337] The annular restriction 2512 can be configured as, for example, a tubular member, a suture loop, or a folded tab. In the illustrated embodiment, the annular restriction 2512 is configured as a suture loop around each respective apex 2506 to which the leaflet engagement mechanism 2504 is mounted. The annular restriction 2506 can also be configured as one or more suture loops around each strut 2502 below the apex 2506 to which the leaflet engagement mechanism 2504 is mounted. The annular restriction 2512 can be integral with the support frame 2500, or can be separately attached.

[0338] Fig.81 A deployment device 2522 ( Fig.83 ) is a portion of an actuation assembly 2534 of the leaflet clip 2508. The actuation assembly 2534 can include an actuator member conduit 2524 sized to receive the proximal hairpin portion 2514 of the leaflet clip 2508, and an actuator member 2526 slidably disposed in the actuator member conduit 2524. The distal portion 2528 of the actuator member 2526 can include a tab 2530 that includes a pin 2532. The pin 2532 can be sized to engage the proximal end of the hairpin portion 2514, such as Fig.82A The actuator member catheter 2524 can then be moved in the direction of arrow 2548 over the distal end portion 2528 of the actuator member 2526 and the engaged hairpin portion 2514, thereby securing the leaflet clip 2508 to the actuator member 2526, as shown. Fig.82B As shown. In this way, longitudinal movement of the actuator member 2526 in the actuator member conduit 2524 can cause corresponding movement of the leaflet clamp 2508 through the annular restriction 2512. This in turn can cause the clamping arm 2510 of the leaflet clamp 2508 to move between an open position and a closed position. The leaflet clamp 2508 can be released by retracting the actuator member conduit 2524, exposing the distal portion 2528 of the actuator member 2526 and allowing the hairpin portion 2514 to disengage from the pin 2532. The deployment device 2522 can include a corresponding actuation assembly 2534 for each leaflet clamping mechanism 2504 of the support frame 2500, such as Fig.83 shown.

[0339] Fig.84 and Fig.85 An alternative embodiment of a distal portion 2528 of an actuator member 2526 is shown. Fig.84 A distal end portion 2528 of the actuator member 2526 is shown including a hook 2536 that is configured to engage the hairpin portion 2514 of the leaflet clip 2508 . Fig.84 The actuator member can be combined with Fig.86 The framework uses Fig.86The frame includes an integral tab 2540 extending from the respective top end 2506 and located radially within the leaflet clamping mechanism 2504. Fig.85 Another embodiment of a distal portion 2528 of an actuator member 2526 is shown having a circular protrusion 2538 positioned toward the proximal end of the tab 2530. The circular shape of the protrusion 2538, along with its position toward the proximal end of the tab 2530, can reduce the tendency of the leaflet clip 2508 to disengage from the actuator member 2526 prematurely.

[0340] Fig.87 25 is a perspective view of a deployment device 2522 coupled to a support frame 2500. The deployment device can include an outer sheath 2550. The actuator member conduits 2524 and associated actuator members 2526 can engage respective leaflet clamping mechanisms 2504 and can pass through the outer sheath 2550. Similarly, the retaining arm engagement members 2552 can pass through the outer sheath 2550 and can engage respective retaining arms 2556 of the support frame. In this way, the respective actuator member conduits 2524, actuator members 2525, retaining arm engagement members 2552, and retaining member conduits 2556 can be actuated independently of one another. Fig.88 The support frame 2500 is shown coupled to the deployment device 2522 with the actuator member 2526 retracted and the leaflet clamp 2508 of the leaflet clamping mechanism 2504 in a closed position.

[0341] Fig.89A and Fig.89B A perspective view of one embodiment of an outer sheath 2540 for use with support frame 2500 is shown. The outer sheath 2540 can include an outer proximal conduit 2542 and three distal conduits 2544 extending from and in communication with the outer proximal conduit 2542. The outer sheath 2540 can also include Fig.89B An inner proximal catheter 2546 is shown which can be configured to be contained within the outer proximal catheter 2542. The actuator member 2526 of the corresponding actuator assembly 2534 can be configured to travel within the lumen of the corresponding distal catheter 2544.

[0342] The following description relates to various embodiments of a support frame configured to be self-retained in a native valve by applying pressure to various anatomical structures of the native valve, such as via one or more frame retaining mechanisms configured to engage portions of the aortic root and / or the aorta. Any of the embodiments described herein having leaflet engagement mechanisms can be provided with one or more frame retaining mechanisms described in detail below, unless the context indicates otherwise. Similarly, any of the embodiments described herein having one or more frame retaining mechanisms can be provided with one or more leaflet engagement mechanisms, unless the context indicates otherwise.

[0343] The following embodiments can be used to treat valvular insufficiency by, for example, reducing the valve circumference or reducing the valve orifice area. The following embodiments can also be used to support a transcatheter heart valve (THV) and can be used in conjunction with any of the support frames described herein. Fig.90 , the support frame or stent 2600 can include an annular body 2601 formed by a plurality of angular struts 2602. The support stent 2600 can include one or more retaining arms 2604 (e.g., three equidistant retaining arms 2604) extending proximally from the top 2606 of the struts 2602. The retaining arms 2604 can be used to form a releasable connection with the distal end of the delivery device, as previously described. In some embodiments, the support stent 2600 can include one or more protrusions or projections (not shown) that can help maintain the THV in an implanted position within the interior of the support stent 2600, as further described in U.S. Patent Application No. 61 / 729,109 and WIPO Publication No. 2014 / 081796, which are incorporated herein by reference.

[0344] Fig.91 and Fig.92 Another embodiment of a support frame 2700 is shown including an annular body formed by a plurality of angular struts 2702, similar to Fig.90 Embodiment of the invention. Fig.91 The support frame 2700 is shown positioned in a partial cross-section of an aorta 2704. The support frame 2700 can also include one or more frame retaining mechanisms configured as arch members 2706. The arch members can be configured to extend radially outward from the support frame and contact the wall of the aortic root 2708. For purposes of illustration, the front half of the support frame is not shown. Fig.92 is a cross-sectional plan view of support frame 2700 positioned in aorta 2704.

[0345] The arch members 2706 can include metal or polymer strips or hooks. In the illustrated embodiment, the arch members 2706 can contact the wall of the aortic root 2708 from substantially the aortic valve 2710 to substantially the sinotubular junction 2712. In this way, the arch members 2706 can hold the support frame 2700 in place after implantation. In alternative embodiments, the height of the arch members 2706 can be configured so that the arch members 2708 contact any suitable portion of the wall of the aortic root 2708.

[0346] Figure 93 to Figure 96 Various embodiments of another support frame 2800 are shown positioned in a partial cross-section of an aorta 2802. The support frame 2800 can include an annular body formed by a plurality of angular struts 2804, similar to the above Fig.90The support stent 2800 can also include one or more elongated frame retention mechanisms configured as vertical members 2806 extending proximally from a apex 2808, which can be formed by the intersection of corresponding adjacent struts 2804. The one or more vertical members 2806 can in turn include one or more elongated horizontal members 2810 configured to contact the wall of the ascending aorta 2812, thereby maintaining the support stent 2800 in place after implantation.

[0347] In some embodiments, the vertical members 2806 can be shaped so that they are biased against the wall of the ascending aorta 2812 when the support stent 2800 is expanded to its fully expanded configuration. Similarly, one or more horizontal members 2810 can be shaped to have a radius greater than the radius of the ascending aorta 2812 so that the horizontal members are biased against the wall of the ascending aorta 2812 when the support stent is fully expanded. The vertical members 2806 and horizontal members 2810 can thus work in concert to hold the support frame 2800 in place after implantation. The vertical members 2806 and horizontal members 2810 can be made of a suitable shape memory metal or alloy, such as spring steel, cobalt chromium alloy, or a combination thereof. or Nitinol, or made from various polymer materials.

[0348] The number, size, and location of vertical members 2806 and horizontal members 2810 can vary depending on the implementation. Fig.93 As shown, the support stent 2800 can include vertical members 2806 extending from each top end 2808 and horizontal members 2810 positioned at intervals along the length of the vertical members 2806. The horizontal members 2810 can also be configured to extend around substantially the entire circumference of the ascending aorta 2812. In some embodiments, the horizontal members 2810 can be coupled to each of the vertical members 2806. Alternatively, the horizontal members 2810 can be coupled to a single vertical member 2806, or any other suitable number of vertical members 2806.

[0349] In further alternative embodiments, the horizontal members 2810 can extend around less than the entire circumference of the ascending aorta 2812 and can be vertically offset from one another, such as Fig.94 and Fig.96 More specifically, Fig.94 As shown, each of the horizontal members 2810 can be centered on a single vertical member 2806 and can extend around two adjacent vertical members 2806 without extending around the entire circumference of the ascending aorta 2812. Alternatively, each of the horizontal members 2810 can be centered on a single vertical member 2806 without extending around adjacent vertical members, such as Fig.96 shown.

[0350] exist Fig.95 In another alternative embodiment shown, the support stent 2800 can include a frame retention mechanism configured as a single vertical member 2806 extending from a single top end 2808. The vertical member 2806 can also include one or more horizontal members 2810 centered on the vertical member 2806 and coupled to the vertical member 2806. If desired, the horizontal member 2810 can be configured to extend around substantially the entire circumference of the ascending aorta 2812 or any portion thereof. The vertical member 2806 and the horizontal member 2810 can be shaped or otherwise configured to contact the wall of the ascending aorta 2812, thereby maintaining the support frame 2800 in place after implantation, as described above. The vertical member 2806 and the horizontal member 2810 can be integrally formed with the support frame 2800, or can be formed separately and fixed to the support frame and / or to each other by, for example, welding, brazing, suturing, adhesives, etc.

[0351] Reference now Fig.97 , showing another embodiment of a support frame 2900 including an annular body formed by a plurality of angular struts 2902 and having a plurality of apexes 2904 formed by the intersection of two adjacent struts 2902, similar to the above Fig.90 2906. The support frame 2900 is shown positioned in a partial cross-section of an aorta 2906. The support frame 2900 can also include a frame retention mechanism configured to be coupled to an annular member 2908 of the support frame 2900 via one or more rigid, or semi-rigid vertical members 2910, the vertical members 2910 extending from respective apexes 2904. The annular member 2908 can be positioned in an aortic root 2912 and can be configured to contact a wall of the aortic root 2912 substantially below the sinotubular junction 2914. Thus, the annular member 2908 in combination with the one or more vertical members 2910 can limit upward movement of the support frame 2900 in the aortic root 2912.

[0352] In the illustrated embodiment, the support frame 2900 can include two vertical members 2910 located on the portion of the support frame in the dorsal half of the aorta 2906, and two vertical members 2910 located on the portion of the support frame in the ventral half (not shown) of the aorta 2906. However, in alternative embodiments, the support frame 2900 can include any suitable number of vertical members 2910 located on any suitable portion of the support frame 2900. The vertical members 2910 can be integrally formed with the support frame 2900, or can be formed separately and secured to the support frame by, for example, welding, brazing, suturing, adhesives, etc.

[0353] Fig.98Another embodiment of a support frame 3000 is shown comprising an annular body formed by a plurality of angular struts 3002, similar to the above Fig.90 3004. The support frame 3000 is shown positioned in a partial cross-section of an aorta 3004. The support frame 3000 can have a plurality of proximal tips 3006 and distal tips 3008 formed by the intersection of two adjacent struts 3002 at the respective proximal and distal ends of the support frame. The struts 3002 can thus define a height H extending from the proximal tips 3006 to the distal tips 3008. The struts 3002 can also be configured to conform to the contour of the aortic root 3010 so that the struts contact the wall of the aortic root 3010. For example, the support frame 3000 can be shaped to have a diameter that is greater than the diameter of the aortic root 3010, thereby causing the struts 3002 to contact the wall of the aortic root 3010 to keep the support stent in place after implantation.

[0354] In the illustrated embodiment, the height H can be configured such that the proximal tip 3004 is located proximal to the sinotubular junction 3012 and the distal tip 3008 is located proximal to the aortic valve 3014. Thus, the struts 3002 can operate as a frame retention mechanism by contacting and applying force to the wall of the aortic root 3010 along substantially the entire length of the aortic root 3010 from proximal to the sinotubular junction 3014 to proximal to the aortic valve leaflets 3014. Alternatively, the height H can be configured such that the struts 3002 contact any suitable portion of the wall of the aortic root 3010. In further alternative embodiments, the proximal tip 3006 can be configured to contact the sinotubular junction 3012 and the distal tip 3008 can be configured to contact the aortic valve leaflets 3014.

[0355] Fig.99A , Fig.99B and Fig.100 Another embodiment of a support frame 3100 is shown comprising an annular body 3101 formed by a plurality of angular struts 3102, similar to the above Fig.90 Embodiment. The support frame 3100 can have a plurality of proximal tips 3104 and distal tips 3106 formed by the intersection of two adjacent struts 3102 at respective proximal and distal ends of the support frame. In the illustrated embodiment, the proximal tips 3104 can include retaining arms 3118 extending from their proximal ends. The support frame 3100 can also include a plurality of frame retaining mechanisms configured as arch members 3108. The arch members 3108 can extend distally from respective distal tips 3106 before bending radially outward and terminating in a rounded distal portion 3110. In the illustrated embodiment, the distal portion 3110 can be oriented generally proximally relative to the support frame 3100. Reference Fig.100When implanted in the aorta 3112, the arch members 3108 can be configured to contact and apply pressure to the wall of the aortic root 3114, thereby keeping the support frame 3100 in place after implantation. In some embodiments, the arch members 3108 can also be configured to contact the bottom of the aortic valve leaflets 3116, such as Fig.100 The arch members 3108 can be integrally formed with the support frame 3100, or can be formed separately and fixed to the support frame 3100 by, for example, welding, brazing, stitching, adhesives, etc.

[0356] Fig.101 Another embodiment of a support frame 3200 including an annular body formed by a plurality of angular struts 3202 is shown. The support frame 3200 is shown in a partial cross-section of the aorta 3204 and can also include a plurality of tops 3206 formed by the intersection of two adjacent struts 3202. The support frame can include one or more frame retaining structures configured as retaining arms 3208 extending proximally from the tops 3206. The retaining arms 3208 can be configured to contact and apply pressure to the wall of the aortic root 3210 and / or the sinotubular connection 3212, thereby pushing the support frame 3200 downward and assisting in keeping the support frame in place after implantation. In the illustrated embodiment, the retaining arms 3208 can be flexible so that they deflect radially inward when contacting the wall of the aortic root 3210 and / or the sinotubular connection 3212. The retaining arms 3208 can be made of metal (e.g., Nitinol) or a suitable biocompatible polymer and can be integrally formed with the support frame 3200 or formed separately and secured to the support frame by, for example, welding, brazing, suturing, adhesives, etc.

[0357] Fig.102Another embodiment of a support frame 3300 comprising an annular body formed by a plurality of angular struts 3302 is shown. The support frame 330 is shown in a partial cross-section of the aorta 3304, and can also include a plurality of tops 3306 formed by the intersection of two adjacent struts 3302. The support frame 3300 can also include a frame retaining mechanism configured to extend from the proximal end of the top 3306 of the support frame 2300 into the ascending aorta 3310. The spring member 3308 can be spirally wound or coiled, and can be shaped to have a diameter greater than the ascending aorta 3310, so that the spring member 3308 contacts and applies force to the wall of the ascending aorta 3310. This in turn can push the support frame 3300 downward, thereby assisting in keeping the support frame in place after implantation. In the illustrated embodiment, the spring member 3308 can originate from a single top 3306. However, in alternative embodiments, the spring member 3308 can originate from any suitable number of tops 3306, including all of the tops 3306. In some embodiments, the spring member 3308 can be configured as a retaining arm that can engage with the delivery device 3312, such as Fig.103 The spring member 3308 can be made of metal (eg, Nitinol) or a suitable biocompatible polymer and can be integrally formed with the support frame 3300 or formed separately and secured to the support frame by, for example, welding, brazing, suturing, adhesives, etc.

[0358] Fig.104 Another embodiment of a support frame 3400 is shown positioned in a partial cross-section of an aorta 3402. The support frame 3400 can include a first annular frame 3404 formed by a plurality of angular struts 3406, and a second annular frame 3408 formed by a plurality of angular struts 3410. The first annular frame 3404 can be positioned in the aortic root 3412 adjacent to the aortic valve leaflets 3414, and the second annular frame 3408 can be positioned in the ascending aorta 3416 adjacent to the sinotubular junction 3418. In some embodiments, the second annular frame 3408 can be configured to have a larger diameter than the diameter of the ascending aorta 3416 so that the second annular frame 3408 applies a radial force to the wall of the ascending aorta 3416. This can allow the second annular frame 3408 to resist proximal and / or distal movement within the ascending aorta 3416.

[0359] The first annular frame 3404 and the second annular frame 3408 can be interconnected by one or more frame retaining mechanisms configured as interconnecting members 3420. One or more interconnecting members 3420 can be coupled to the proximal tip 3422 of the first annular frame 3404 and to the distal tip 3424 of the second annular frame 3408, and can be spring biased. In this way, the interconnecting members 3420 can push the first annular member 3404 downward, thereby assisting in keeping the frame 3400 in a proper position after implantation. In the illustrated embodiment, the interconnecting members 3420 can be configured to deflect and contact the wall of the aortic root and / or the sinotubular connection 3418, thereby further increasing the stability of the support frame 3400 after implantation. In some embodiments, the interconnecting members 3420 can be made of metal (e.g., nitinol) or a suitable biocompatible polymer, and can be integrally formed with the first annular frame 3404 and the second annular frame 3408. Alternatively, the interconnecting member 3420 and the first annular frame 3404 and the second annular frame 3408 can be formed separately and secured together by, for example, welding, brazing, stitching, adhesives, etc.

[0360] Fig.105 Another embodiment of a support frame 3500 is shown positioned in a partial cross-section of an aorta 3502. The support frame 3500 can include a first annular frame 3504 formed by a plurality of angular struts 3506 and a second annular frame 3508 formed by a plurality of angular struts 3510, similar to Fig.104 The first annular frame 3504 can be located in the aortic root 3512 adjacent to the aortic valve leaflets 3514, and the second annular frame 3508 can be located in the ascending aorta 3516 adjacent to the sinotubular junction 3518. In some embodiments, the second annular frame 3508 can be configured to have a larger diameter than the diameter of the ascending aorta 3516 so that the second annular frame 3508 applies a radial force to the wall of the ascending aorta 3502. This can allow the second annular frame 3508 to resist proximal and / or distal movement within the ascending aorta 3516.

[0361] The first annular frame 3504 and the second annular frame 3508 can be interconnected by a frame retaining mechanism configured as a spring member 3520. The spring member 3520 can be coupled to the corresponding proximal top 3522 of the first annular frame 3504 and to the corresponding distal top 3524 of the second annular frame 3508, and can be spirally coiled. In this way, the spring member 3520 can push the first annular frame 3504 downward, thereby helping to keep the support frame 3500 in a proper position after transplantation. In the illustrated embodiment, the spring member 3520 is coupled to a single proximal top 3522 of the first annular frame 3504 and a single distal top 3524 of the second annular frame 3508. Alternatively, the spring member 3520 can be coupled to multiple proximal tops 3522 and / or multiple distal tops 3524 of the first annular frame 3504 and the second annular frame 3508, respectively. In another alternative embodiment, the support frame 3500 can include multiple spring members 3520. In some embodiments, the spring member 3520 can be made of metal (e.g., Nitinol) or a suitable biocompatible polymer and can be integrally formed with the first annular frame 3504 and the second annular frame 3508. Alternatively, the spring member 3520 and the first annular frame 3504 and the second annular frame 3508 can be formed separately and secured together by, for example, welding, brazing, suturing, adhesives, etc.

[0362] Figures 106 to 108 Another embodiment of a support frame 3600 is shown, the support frame 3600 includes a first annular frame 3602 formed by a plurality of angled struts 3604 and a second annular frame 3606, the second annular frame 3606 including a plurality of frame subunits 3608 formed by a corresponding number of branch members 3610. The first annular frame 3602 can be configured to be located within the aortic root, and the second annular frame 3606 can be configured to be located within the ascending aorta, similar to Fig.104 and Fig.105 Embodiment. The frame subunits 3608 of the second annular frame 3606 can include a proximal tip 3612 formed by the proximal intersection of two corresponding branch members 3610 and a distal tip 3614 formed by the corresponding distal intersection of the branch members 3610. In the illustrated embodiment, the alternating proximal tips 3612 can include retaining arms 3616 extending therefrom. The second annular frame 3606 can be configured to have a diameter larger than the diameter of the ascending aorta so that the second annular frame 3608 applies a radial force to the wall of the ascending aorta. This can allow the second annular frame 3606 to prevent proximal and / or distal movement within the ascending aorta. The frame subunits 3608 can be selectively coupled via short coupling members 3622, which can increase the stiffness of the second frame 3606.

[0363] The first annular frame 3602 and the second annular frame 3606 can be interconnected by one or more frame retaining mechanisms configured as interconnecting members 3618. One or more interconnecting members 3618 can be coupled to the corresponding proximal tops 3620 of the first annular frame 3602 and the corresponding distal tops 3614 of the second annular frame 3606, and can be spirally coiled. In this way, the interconnecting members 3618 can push the first annular frame 3602 downward, thereby helping to keep the support frame 3600 in a proper position after transplantation. In the illustrated embodiment, the interconnecting members 3618 interconnect each proximal top 3620 of the first annular frame 3602 with each distal top 3614 of the second annular frame 3606. Alternatively, the interconnecting members 3618 can interconnect every two (every other) proximal tops 3620 of the first annular frame 3602 with every two distal tops 3614 of the second annular frame 3606. In another alternative embodiment, each proximal end 3620 of the first annular frame 3602 can be interconnected with each distal end 3614 of the second annular frame 3606 by a plurality of pairs of interconnecting members 3618, such as Fig.108 As shown. Fig.108 In some embodiments, each corresponding pair of interconnecting members 3618 can extend from a corresponding proximal tip 3620 of the first annular frame 3602 to a distal tip 3614 of the second annular frame in opposite radial directions about the support frame 3600 (i.e., one interconnecting member 3618 can extend in a clockwise direction and the other interconnecting member can extend in a counterclockwise direction prior to coupling to a corresponding distal tip 3614 of the second frame 3606). Additionally, in some embodiments, the support frame 3600, and in particular the second frame 3608, can be configured to be axially compliant so that the geometry of the support frame 3600 can be altered to accommodate changes in the shape of the ascending aorta.

[0364] Figures 109 to 112 Another embodiment of a support frame 3700 is shown including an annular body 3701 formed by a plurality of angular struts 3702 and having a plurality of apexes 3704 formed by the intersection of two adjacent struts 3702. Fig.110 and Fig.112 , the support frame 3700 is shown positioned within a partial cross-section of the aorta 3706. The support frame 3700 can also include a frame retaining mechanism configured to be coupled to the semi-annular member 3708 of the support frame 3700 via two rigid or semi-rigid vertical members 3710 extending from respective top ends 3704, similar to Fig.97 The support frame 3700 can be located within the aortic root 3712, and the semi-circular member 3708 can be located within the ascending aorta 3714, such as Fig.110 and Fig.112 shown.

[0365] In the illustrated embodiment, the vertical member 3710 can be integral with the semi-annular member 3708 and can be shaped so that the semi-annular member 3708 has a diameter that is larger than the diameter of the ascending aorta 3714. In this way, the semi-annular member 3708 can be configured to apply a radial force to the wall of the ascending aorta 3714, which, in conjunction with the two vertical members 3710, can limit the upward movement of the support frame 3700 in the aortic root 3712. For example, in Fig.109 In an embodiment of the present invention, the vertical members 3710 can be shaped so that they extend at an angle away from each other in the proximal direction, thereby radially advancing the semi-annular members 3708 outward. In this way, when the support frame is in the fully expanded configuration, the semi-annular members 3708 can have a diameter that is larger than the diameter of the ascending aorta 3714. Alternatively, the vertical members 3710 can be shaped so that when the support frame is in the expanded configuration, they are oriented substantially parallel to the longitudinal axis of the support frame 3700, and the semi-annular members 3708 can be configured to have a diameter that is larger than the diameter of the ascending aorta 3714 and are not advanced by the vertical members 3710, such as Fig.111 Thus, the vertical members 3710 can be pushed toward each other by the radial compression of the semi-circular members 3708 imposed by the wall of the ascending aorta 3714, as shown. Fig.110 and Fig.112 As shown respectively, this can help maintain the support frame 3700 in the proper position after implantation.

[0366] The vertical member 3710 and the semi-annular member 3708 can be made of metal (e.g., Nitinol) or of a suitable biocompatible polymer and can be integrally formed with the support frame 3700. Alternatively, the vertical member 3710 and the semi-annular member 3708 can be formed separately and secured to the support frame 3700 by, for example, welding, brazing, suturing, adhesives, etc.

[0367] Figures 113 to 115 Another embodiment of a support frame 3800 is shown including an annular body 3801 formed by a plurality of angular struts 3802 and having a plurality of apexes 3804 formed by the intersection of two adjacent struts 3802. The support frame 3800 can include a plurality of frame retaining members 3806 configured as retaining rings 3808. The retaining rings 3808 can be located within the aortic root 3818 behind the native leaflets 3820 (see, e.g., Fig.117 and Fig.118 ) and can be configured to apply radial force to the wall of the aortic root 3818 to help maintain the support frame 3800 in the proper position after implantation.

[0368] Each retaining member 3806 can include a proximal portion 3810 and a distal portion 3812. The proximal portion 3810 can be formed by a respective end portion 3814 of a ring or wire 3808, which can extend proximally from the respective tip 3804 before being bent distally. In this way, the proximal portion 3810 can define a leaflet coaptation region 3822 that is configured to receive a native leaflet 3820, and when the support frame is implanted, the respective end portion 3814 of the ring 3808 can extend over the native valve leaflet 3820 (see, e.g., Fig.117 and Fig.118 ). The distal portion 3812 of the retention member 3806 can be defined by a middle portion 3816 of the ring or wire 3808 and can have a radial profile to distribute forces to the wall of the aortic root 3818 (e.g., during maximum pressure differentials during the cardiac cycle).

[0369] In some embodiments, the ring or wire 3808 can extend a distance of about 5 mm to about 10 mm proximal to the top end 3804 of the support frame 3800 before the distal end is bent. In some embodiments, the distal portion 3812 of the retaining member 3806 can have a height of about 12 mm to about 18 mm. In this way, the height of the retaining member 3806 can be approximately equal to the height of the native valve leaflet 3820, which can reduce the possibility of damage to the leaflet 3820 during and after implantation.

[0370] refer to Fig.114 and Fig.115 , the support frame 3800 is capable of radial collapse so that it can be loaded onto the delivery device 3824 via a loading device (such as a funnel loader 3826) in the direction of arrow 3832, as shown. Fig.114 3824. Alternatively, the support frame 3800 can be loaded onto the delivery device 3824 using any of a variety of other loading devices, including a reverse crimper and a circular dilator. In some embodiments, the support frame 3800 can be radially collapsed around a transcatheter heart valve ("THV") 3828, which itself can be radially collapsed around a balloon catheter 3830. The THV 3828 can have a balloon-expandable metal frame that supports valve components, such as a plurality of tissue leaflets supported by the frame.

[0371] like Fig.115 As shown, the support frame 3800 can be held in place by an outer sheath 3834. Contracting the outer sheath 3834 can allow the retaining ring 3808 to extend radially into the aortic root 3818 behind the native valve leaflets 3820, as shown in FIG. Fig.117 and Fig.118With the retaining ring 3808 in place behind the leaflet 3820, the balloon catheter 3830 can be inflated, thereby radially expanding the THV 3828 into its fully expanded configuration and capturing the leaflet 3820 between the THV 3828 and the support frame 3800, as shown. Fig.119 With the THV 3828 anchored in place, the balloon catheter 3830 can be deflated and the delivery device 3824 can be retracted so that the support frame 3800 and THV 3828 are implanted within the aortic root 3818, as shown. Fig.120 shown.

[0372] The support frame 3800 can be configured such that when the THV 3828 and the support frame 3800 are radially expanded by the balloon catheter 3830, the support frame 3800 exerts a constant or nearly constant radial force on the THV 3828. For example, Fig.116 As shown in the stress-strain graph of , the THV 3828 can be configured to have a diameter of about 6 mm when the THV 3828 collapses radially around the delivery device 3824, and to have a diameter of about 30 mm when the THV 3828 is fully expanded. The support frame 3800, which can collapse onto the delivery device 3824 over the THV 3828, can have a corresponding diameter when the support frame 3828 collapses and expands radially. The radial force applied to the THV 3828 by the support frame 3800 can remain constant or increase only slightly when the support frame 3800 and the THV 3828 expand from a radially collapsed state to a fully expanded state. This is achieved by Fig.116 The area between the curves 3838 and 3840 is shown, indicating that the support frame 3800 absorbs a nearly constant amount of strain energy when the support frame and THV 3828 are expanded. In this way, the rate and degree of expansion of the THV 3828 using a balloon catheter can be precisely controlled. In an alternative embodiment, any of the support frames / struts described herein can be implanted with a THV using the delivery device 3824 and the delivery techniques described above.

[0373] exist Fig.121In the illustrated alternative embodiment, the retaining ring 3808 can include a planar member 3840 coupled to and depending from a pair of coupling members 3842. The coupling members 3842 can extend proximally from the respective top ends 3804 before being bent distally and coupled to the planar members 3840, thereby defining a leaflet engagement region 3844 similar to the leaflet engagement region 3822. In some embodiments, the planar member 3840 can include a sheet of material (e.g., a metal such as nitinol, a polymeric material, etc.) and can have a radial profile. In some embodiments, the planar member 3840 and / or the coupling members 3842 can be covered in a fabric to cushion the load applied to the walls of the aortic sinus 3818 and promote ingrowth of surrounding tissue. In further alternative embodiments, the delivery device 3824 need not include a THV 3828. Instead, the support frame 3800 can be implanted and positioned within the aorta to reshape the leaflets 3820 to address, for example, aortic valve insufficiency.

[0374] Figures 122 to 126 Another embodiment of a support frame 3900 is shown including an annular body 3901 formed by a plurality of first struts 3902 and second struts 3904. Corresponding pairs of first struts 3902 can intersect at a first proximal tip 3906 and define a leaflet engagement mechanism 3908. Similarly, corresponding pairs of second struts 3902 can intersect at a second proximal tip 3910, thereby defining an actuator mechanism 3912. The leaflet engagement mechanism 3908 can be moved in an open position ( Fig.124 ) and closed position ( Fig.125 ) can be moved between them, and the relevant parts are Figures 124 to 126 Shown in.

[0375] The delivery device 3914 can include a plurality of first and second actuator members 3922, 3924 configured to respectively engage the first and second tips 3906, 3910 of the leaflet engagement mechanism 3908 and the actuator mechanism 3912. The first actuator member 3922 can be configured to apply a compressive axial force to the first tip 3906 of the leaflet engagement mechanism 3908 in the direction indicated by arrow 3928 (i.e., the first actuator member 3922 can be configured to push the first tip 3906 of the leaflet engagement mechanism 3908 downward). At the same time, the second actuator member 3924 can be configured to apply a tensile force to the second tip 3910 of the actuator mechanism 3912 in the direction indicated by arrow 3930 (i.e., the second actuator member 3924 can be configured to pull the second tip 3910 of the actuator mechanism 3912 upward). In this way, the combined action of the first actuator member 3922 and the second actuator member 3924 can cause the second struts 3904 of the actuator mechanism 3912 to converge, while the first struts 3902 of the corresponding leaflet engagement mechanism 3908 are pulled apart, thereby moving the leaflet engagement mechanism 3908 into an open position, such as Fig.124 When the corresponding compressive and tensile forces applied to the leaflet engagement mechanism 3908 and the actuator mechanism 3912 are released, the leaflet engagement mechanism 3908 can return to the closed position ( Fig.125 Thus, when the support frame 3900 is implanted in the aorta 3946, the leaflet engagement mechanism 3908 is able to engage and retain the native valve leaflets 3944, such as Fig.126 shown.

[0376] Fig.123 Detailed views of representative leaflet engagement mechanisms 3908 are shown. Each leaflet engagement mechanism 3908 can include a proximal portion 3916, a spring portion 3918, and a leaflet engagement portion 3920. The proximal portion 3916 can include an aperture 3926 configured to engage a corresponding first actuator member 3922 ( Fig.124). The spring portion 3918 can include two spring subunits 3932, one spring subunit 3932 located on each corresponding first strut 3902 of the leaflet engagement mechanism 3908. Each spring subunit 3932 can include a spring member 3934 and a pair of travel limiting members 3936. Each corresponding pair of travel limiting members 3936 can define a gap 3938 therebetween. When an axial force is applied to the leaflet engagement mechanism 3908 and tension is applied to the adjacent actuator mechanism 3912 by the corresponding first actuator member 3922 and the second actuator member 3924 of the delivery device 3914, the struts 3902 can be pulled apart in the direction of arrow 3948. This can bias the spring members 3934 away from each other. At the same time, each pair of corresponding travel limiting members 3936 can gather until the travel limiting members 3936 contact, thereby limiting further travel of the spring members 3934 and therefore further travel of the first struts 3902.

[0377] The leaflet engagement portion 3920 of the leaflet engagement mechanism 3908 can define a leaflet engagement region 3940 between respective first struts 3902 configured to receive autologous leaflets 3944. In some embodiments, the leaflet engagement region 3940 can extend between respective spring members 3934 of the spring subunit 3932. In the illustrated embodiment, the opposing surfaces of the first struts 3902 of the leaflet engagement portion 3920 can include barbs 3942 configured to engage and retain autologous leaflets. In alternative embodiments, the opposing surfaces of the first struts 3902 of the leaflet engagement portion 3920 can include any suitable surface treatment, such as protrusions, cutouts, surface roughness, etc., if desired. In some embodiments, the first struts 3902 and the second struts 3904 can be integrally formed with the support frame 3900. Alternatively, the first struts 3902 and the second struts 3904 can be formed separately and secured together by, for example, welding, brazing, suturing, adhesives, etc.

[0378] Figure 127 to Figure 129 Another embodiment of a support frame 4000 comprising an annular body formed by a plurality of curved inner members 4002 and outer members 4004 is shown, the inner members intersecting the outer members at three corresponding tops or apexes 4006. The support frame 4000 can be configured to have a diameter smaller than the diameter of the regurgitant native valve so that when implanted, the support frame 4000 can reduce the valve circumference and thus reduce the valve orifice area. Thus, the support frame 4000 can effectively "re-mold" the structure of the regurgitant valve at the bottom of the leaflets. In some embodiments, the support frame 4000 can pull the commissures of the native valve together, thereby improving the leaflet coaptation (improving valve function). The support frame 4000 also provides a limit to the further advancement of valve expansion.

[0379] The inner members 4002 can be arranged to form an inner trefoil piece 4008 having three inner top ends 4010 formed by the intersection of adjacent inner members 4002. The outer members 4004 can be arranged to form an outer trefoil piece 4012 that is concentric with the inner trefoil piece 4008 and has a diameter greater than the diameter of the inner trefoil piece 4008. The inner top ends 4010 of the inner trefoil piece 4008 can be coupled to the corresponding top 4006 near the center of the top 4006, and the outer members 4004 can be coupled to the sides of the corresponding top 4006. In this way, the inner members 4002 and the outer members 4004 can define a gap 4014 therebetween that extends along each side of the support frame 4000.

[0380] In the illustrated embodiment, the inner member 4002 and the outer member 4004 can be substantially parallel, wherein the inner member 4004 extends radially inwardly of the outer member 4004. Thus, the gap 4014 can be configured to receive the native leaflets 4016 of the aortic valve 4018 (shown as dashed lines), wherein the inner member 4002 is located along the ventricular surface of the leaflets 4016 and the outer member 4004 is located along the aortic surface of the leaflets 4016 (when implanted in the native aortic valve). In some embodiments, the inner member 4002 and the outer member 4004 can be shaped so that they are spring-biased toward each other. Thus, when the leaflets are inserted therebetween, the inner member 4002 and the outer member 4004 can clamp and hold the native leaflets 4016, thereby remolding the aortic valve 4018 by reducing the valve circumference and / or valve orifice area. The inner member 4002 and the outer member 4004 can be made of metal (e.g., Nitinol) or of a suitable biocompatible polymer and can be integrally formed with the support frame 4000. Alternatively, the inner member 4002 and the outer member 4004 can be formed separately and secured to the support frame 4000 by, for example, welding, brazing, suturing, adhesives, etc.

[0381] refer to Fig.128, the support frame 4000 can be configured to be loaded onto a delivery device 4020 in a radially collapsed state. The delivery device 4020 can be configured so that the inner cloverleaf piece 4008 is maintained in a radially collapsed state by the inner sheath 4022, and the outer cloverleaf piece 4012 is maintained in a radially collapsed state by the outer sheath 4024. When the delivery device 4020 is located in the aorta, the outer sheath 4024 can be partially retracted in the direction of arrow 4026, thereby exposing the distal aspect of the outer cloverleaf piece 4012. The partial exposure of the outer cloverleaf piece 4012 can cause the outer member 4004 to expand to a diameter larger than the diameter of the aortic valve. The outer member 4004 can be placed in a native sac or sinus behind the native leaflet. The inner sheath 4022 can then be advanced in the direction of arrow 4028, exposing the inner cloverleaf piece 4008. Because the proximal aspect of the inner trefoil 4008 remains constrained by the outer sheath 4024, the inner member 4002 is able to expand outward to a diameter that is larger than the diameter of the inner trefoil in the fully expanded configuration.

[0382] When the outer member 4004 of the outer trefoil 4012 is properly positioned behind the native leaflets (i.e., on the aortic side of the leaflets) and the inner member 4002 of the inner trefoil 4008 is properly positioned on the ventricular side of the native leaflets, the outer sheath 4024 can be fully retracted. The inner trefoil 4008 and outer trefoil 4012 can then return to their respective natural diameters, engaging the native leaflets between the inner trefoil 4008 and outer trefoil 4012 and gathering the native leaflets, thereby reducing the circumference of the aortic valve and / or reducing the orifice area of ​​the aortic valve.

[0383] exist Fig.129 In the illustrated alternative embodiment, the proximal portion of the inner sheath 4022 can include a balloon 4032 configured to expand the outer member 4004 of the partially exposed outer cloverleaf 4012 when expanded. Alternatively, the inner sheath 4022 can have a region of increased diameter configured to expand the outer member 4004 of the outer cloverleaf 4012 when the outer sheath 4024 is retracted.

[0384] Fig.130Another embodiment of a support frame 4100 is shown including an annular body configured as a trefoil 4104 formed by a plurality of angular struts 4102. The trefoil 4104 can have three apices 4106 formed by the intersection of adjacent struts 4102. The support frame 4100 can also include a leaflet engagement mechanism in the form of a clamping member 4108 coupled to each of the respective apices 4106. The clamping member 4108 can include a retaining arm 4110 that can extend through a sleeve 4111 coupled to the apices 4106 of the trefoil 4104. The retaining arm 4110 can include a coupling member configured as a clamp 4122 that can engage a bulbous end portion 4124 of an elongated member 4112 of a delivery device 4114, as shown. Fig.130 As such, the clamping member 4108 can be movable between a clamped position and an unclamped position by the action of the elongated member 4112 of the delivery device 4114.

[0385] The clamping members 4108 can be located at the commissures 4118 of the aortic valve 4116 so that when the clamping members 4108 are moved from an unclamped position to a clamped position, the native leaflets 4120 can be clamped against the underlying struts 4102 of the trefoil 4104. In some embodiments, the trefoil 4104 can be configured to have a diameter that is smaller than the natural diameter of the aortic valve 4116. Thus, when the native leaflets 4120 are clamped against the trefoil 4104 by the clamping members 4108, the support frame 4100 can re-mold the aortic valve 4116 by focusing the native valve leaflets 4120. This can reduce the circumference of the aortic valve 4116 and reduce the area of ​​the valve orifice, thereby reducing regurgitation.

[0386] The support frame 4100 can be loaded onto the delivery device 4114, and the coupling member 4122 of the clamping member 4108 engages the bulbous end portion 4124 of the elongated member 4112. Initially, the clamping member 4108 can be located above the trefoil 4104 so as not to interface with the placement of the trefoil 4104. The delivery device 4124 can be advanced through the surgical opening in the left ventricle and into the aorta, where the trefoil 4104 can be positioned so that the apex 4106 can be located between the leaflets 4120 at the commissures 4118 of the aortic valve 4116. When the trefoil 4104 is properly positioned, the elongated member 4112 can be retracted, thereby moving the clamping member 4108 from the unclamped position to the clamped position. This in turn can cause the leaflets 4120 to be squeezed between the clamping member 4108 and the struts 4102 of the trefoil 4104. The coupling member 4122 can then be disengaged from the ball-shaped end portion 4124 of the slender member 4112, and the delivery device 4114 can be retracted.

[0387] In view of the fact that the principles of the disclosed invention can be applied to many feasible embodiments, it should be understood that the illustrated embodiments are only preferred embodiments of the invention and should not be considered to limit the scope of the invention. On the contrary, the scope of the invention is defined by the following claims. We therefore claim all rights within the scope and spirit of these claims.

Claims

1. A support frame configured to be implanted at a native heart valve, the support frame comprising: an annular body configured as a trefoil formed by a plurality of angular struts, the trefoil being capable of having three apexes formed by intersections of adjacent struts; a leaflet engagement mechanism in the form of a clamping member coupled to each of the respective apexes to help secure the support frame at the native heart valve, Wherein the clamping member includes a retaining arm extending through a sleeve coupled to the top end of the clover leaf.

2. The support frame according to claim 1, wherein: The gripping member is movable between a clamped position and an unclamped position by the action of an elongated member of the delivery device.

3. A valvular insufficiency repair system, comprising: Conveying device; a valvular insufficiency repair device coupled to the delivery device; The valvular insufficiency repair device comprises: a support frame, the support frame comprising an annular body formed by a plurality of struts and one or more active leaflet engagement mechanisms comprising two clamping arms; wherein the clamping arm is movable between an open position and a closed position; wherein the clamping arm is capable of being biased toward the closed position; wherein the delivery device is configured to maintain the plurality of clamp arms in the open position when the plurality of clamp arms are mounted on the delivery device prior to implantation; and The delivery device is configured to allow the plurality of clamping arms to move to the closed position to engage native heart valve leaflet tissue.

4. The valvular insufficiency repair system according to claim 3, wherein the frame is configured to treat valvular insufficiency.

5. The valvular insufficiency repair system of claim 3, wherein the clamping arm can include respective proximal portions, intermediate portions, and distal leaflet coaptation portions.

6. The valvular insufficiency repair system according to claim 5, wherein the proximal portion of the clamping arm includes a hole or an eyelet configured to receive a wire or a flexible fork.

7. The valvular insufficiency repair system according to claim 3, wherein the connecting member is capable of acting as a fulcrum, and the clamping arm pivots around the fulcrum when moving between the open position and the closed position.

8. A valvular insufficiency repair system according to claim 3, wherein before insertion into a patient, the flexible fork of the delivery device is capable of passing through the hole of the retaining arm and through the hole thread of the clamping arm so that the clamping arm is retained in the open position.

9. The valvular insufficiency repair system according to claim 6, wherein the flexible fork is retracted through the hole of the clamping arm to release the clamping arm.

10. The valvular insufficiency repair system of claim 3, wherein the delivery device comprises a wire or a flexible fork passing through the clamping arm to hold the clamping arm in the open position.

11. The valvular insufficiency repair system according to claim 5, wherein the leaflet engagement portion includes a protrusion configured to engage and retain the native leaflet between the clamping arms.

12. The valvular insufficiency repair system of claim 3, wherein the clamping arms are laser cut.

13. The valvular insufficiency repair system of claim 3, wherein the clamping arms are configured to engage a pair of native heart valve leaflets.

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