Heart valve support devices

Abstract

The device for assisting the tricuspid valve function of the heart includes a shaft, a flow optimizer and an anchoring mechanism. The tilting mechanism can be configured to tilt the shaft relative to the central axis of the anchoring mechanism. The leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and an edge, and the edge can have a higher stiffness than the membrane.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 851,503, filed on May 22, 2019, entitled “Heart Valve Support Device,” and U.S. Provisional Application No. 62 / 976,232, filed on February 13, 2020, entitled “Heart Valve Support Device,” the entire contents of which are incorporated herein by reference.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0005] background

[0006] The tricuspid valve (TV) is an atrioventricular valve located on the right side of the human heart between the right atrium (RA) and the right ventricle (RV). The TV consists of three asymmetric leaflets (septal, anterior, and posterior) supported by a complex subvalvular apparatus that includes chordae tendineae and papillary muscles. The TV is also located near the tendon of Todaro, where the heart's delicate atrioventricular node is located.

[0007] When the tricuspid valve is incompetent, regurgitant flow occurs during the systolic phase of the cardiac cycle. This insufficiency is usually caused by a pathologically induced progressive enlargement of the valve annulus that prevents the leaflets from achieving complete docking during systole (or the contractile phase of the cardiac cycle). Lack of docking results in the formation of a regurgitant orifice within the valve through which blood can re-enter the right atrium rather than exit the right ventricle via the pulmonary valve. This condition induces cardiac overload with subsequent right ventricular and right atrium enlargement, decreased right ventricular stroke volume, increased systemic venous congestion, and other symptoms of congestive heart failure. Tricuspid regurgitation may occur in isolation or in association with other valvular diseases, potentially leading to congestive heart failure, reduced functional cardiovascular capacity, and an increased risk of premature death.

[0008] Surgical repair or replacement is the most commonly used technique for the treatment of tricuspid regurgitation, but clinical outcomes such as mortality and recurrence rates are not ideal. In addition, due to the common presence of several complications in patients affected by tricuspid regurgitation, most patients are not eligible for surgical repair or replacement due to the high risks associated with these procedures.

[0009] Transcatheter therapy does not require open-heart surgery and may be a viable and safer alternative. However, the unique anatomical features of the tricuspid valve present a significant challenge to the development of safe and effective transcatheter implants. For example, anchoring the implant in the tricuspid valve may require burdening adjacent cardiac structures (e.g., the superior or inferior vena cava, the atrioventricular node, the coronary sinus, the right coronary artery, or the ventricular myocardium). In addition, the low pressure and output of hemodynamic flow through the right tricuspid valve of the heart increases the risk of inducing atrioventricular pressure gradients and thrombosis. Therefore, there is a need for a transcatheter tricuspid valve implant that overcomes some or all of these challenges.

[0010] Overview of the Disclosure

[0011] In general, in one embodiment, a device for assisting the tricuspid valve function of the heart includes a shaft, a flow optimizer, an anchoring mechanism, and a ball. The flow optimizer is fixedly connected to the distal end of the shaft. The anchoring mechanism includes a core having a socket in the core. The ball is located in the socket and has an inner cavity in the ball, and the shaft is configured to extend through the inner cavity. The ball is configured to rotate in the socket so as to tilt the shaft relative to the central axis of the anchoring mechanism.

[0012] In general, in one embodiment, a device for assisting the tricuspid valve function of the heart includes a shaft, a flow optimizer, an anchoring mechanism, and a rotating element. The flow optimizer is fixedly connected to the distal end region of the shaft. The anchoring mechanism includes a core having a socket in the core. The rotating element is positioned in the socket and has an inner cavity in the rotating element, and the shaft is configured to extend through the inner cavity. The rotating element is configured to rotate in the socket so as to tilt the shaft relative to the central axis of the anchoring mechanism.

[0013] This embodiment and other embodiments may include one or more of the following features. The shaft may be configured to slide and rotate axially within the lumen. The core may include an angled ledge configured to limit the angle of the flow optimizer relative to the anchoring mechanism. The angle may be less than 45 degrees. The device may also include a locking mechanism configured to lock the tilt angle of the flow optimizer relative to the anchoring mechanism. The locking mechanism may also be configured to lock the axial and rotational position of the flow optimizer relative to the anchoring mechanism. The locking mechanism may include one or more screws configured to extend through the core and engage the ball. The locking mechanism may include an annular lock configured to fit between the core and the ball. The annular lock may be configured to move axially between a proximal position and a distal position, at which the ball is configured to rotate at the proximal position and fixed at the distal position. The annular lock may be a snap fit lock. The annular lock may include a threaded groove configured to match the threaded groove on the inner surface of the core. The flow optimizer may include a frame and a plurality of leaflets attached to the frame. The plurality of leaflets may be configured to expand to an expanded configuration during systole to block blood flow around the flow optimizer and collapse to a contracted configuration during diastole to allow blood flow around the flow optimizer. The anchoring mechanism may also include a plurality of anchoring arms extending radially away from the core.

[0014] In general, in one embodiment, a method for assisting tricuspid valve function of the heart includes: (1) inserting a tricuspid valve device into a native tricuspid valve, wherein the tricuspid valve device includes an axis, a flow optimizer, and an anchoring mechanism; (2) securing the anchoring mechanism at the commissures leaflets of the native tricuspid valve; and (3) tilting the axis relative to a central axis of the anchoring mechanism so as to position the flow optimizer at a desired angular position within the native tricuspid valve.

[0015] This embodiment and other embodiments may include one or more of the following features. The tilting shaft may include a ball that rotates within a socket of the tricuspid valve device. The method may also include, during diastole, reducing the cross-sectional area of ​​the flow optimizer to allow hemodynamic flow around and through the flow optimizer, and during systole, increasing the cross-sectional area of ​​the flow optimizer to seal the orifice of the natural tricuspid valve. The method may also include axially moving the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired axial position within the natural tricuspid valve. The method may also include rotating the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired rotational position within the natural tricuspid valve. The method may also include locking the flow optimizer at a desired angular position with a locking mechanism. The locking mechanism may also lock the axial and rotational position of the flow optimizer relative to the anchoring mechanism. The locking mechanism may include one or more screws configured to extend through the core and engage with the ball. The locking mechanism may include an annular lock configured to fit around the shaft. Locking may include moving the annular lock distally relative to the anchoring mechanism. Locking may include rotating the annular lock relative to the anchoring mechanism.

[0016] In general, in one embodiment, a device for assisting tricuspid valve function of the heart includes a flow optimizer, the flow optimizer including a frame having a plurality of arms and a plurality of leaflets attached to the plurality of arms. The plurality of leaflets are configured to expand to an expanded configuration during systole to block blood flow around the flow optimizer, and to contract to a contracted configuration during diastole to allow blood flow around the flow optimizer. Each leaflet of the plurality of leaflets includes a membrane and a rim, and the rim has a higher stiffness than the membrane.

[0017] This embodiment and other embodiments may include one or more of the following features. The plurality of leaflets may also be configured to be compressed into a compressed configuration to allow blood flow through the flow optimizer. The thickness of the membrane may be less than 75% of the thickness of the edge. Each of the plurality of leaflets may have a substantially triangular shape. Each of the plurality of leaflets may include a first layer and a second layer, and the second layer may overlap at least partially with the first layer. The first layer may be configured to be positioned toward the atrium, and the second layer may be configured to be positioned toward the ventricle. The second layer may be positioned radially outward of the first layer so that a gap is formed between the atrial end of the second layer and the ventricular end of the first layer. The shape of the second layer may be substantially quadrilateral, and the shape of the first layer may be substantially triangular. The edge may be positioned along two edges of the first layer and not along the ventricular end of the first layer. The edge may be positioned along three edges of the second layer and not along the ventricular end of the second layer. The leaflet may have a first edge, a second edge, and a third edge, and the edge may be positioned only along the first edge and the second edge. The first edge and the second edge may meet at a vertex that is configured to be positioned closer to the atrium than the third edge. The plurality of leaflets may be sutured to the frame using a plurality of sutures extending parallel to the frame arms. The margin may include a fabric. The fabric may be polyethylene terephthalate. The fabric may be coated with polyurethane and silicone. The membrane may include a polymer membrane. The membrane may include polyurethane and silicone. The device may also include an anchoring mechanism configured to anchor the device in a natural tricuspid valve. The anchoring mechanism may include a plurality of anchoring arms extending radially therefrom.

[0018] In general, in one embodiment, a method of assisting tricuspid valve function of the heart includes: (1) implanting a flow optimizer into a native tricuspid valve orifice, wherein the flow optimizer includes a plurality of leaflets, and wherein each leaflet has a first layer and a second layer, the first layer and the second layer each including a membrane and an edge; (2) during diastole, constricting the plurality of leaflets to allow hemodynamic flow around and through the flow optimizer, wherein constricting the plurality of leaflets includes moving the first layer radially inward before the second layer to create a gap therebetween; and (3) during systole, expanding the plurality of leaflets to seal the tricuspid valve orifice.

[0019] This embodiment and other embodiments may include one or more of the following features. The edge may have a higher stiffness than the membrane. The second layer may at least partially overlap the first layer. The first layer may be positioned toward the atrium and the second layer may be positioned toward the ventricle. The second layer may be located radially outward from the first layer so that a gap is formed between the atrial end of the second layer and the ventricular end of the first layer. The shape of the second layer may be substantially quadrilateral, and the shape of the first layer may be substantially triangular. The edge may be positioned along two edges of the first layer and not along the ventricular end of the first layer. The edge may be positioned along three edges of the second layer and not along the ventricular end of the second layer. Expanding multiple leaflets may include closing the gap.

[0020] In general, in one embodiment, a device for implantation includes a shaft, a flow optimizer fixedly connected to the shaft, and an anchoring mechanism. The shaft is configured to slide axially and rotationally relative to the anchoring mechanism to adjust the axial and rotational position of the flow optimizer relative to the anchoring mechanism.

[0021] This and other embodiments may include one or more of the following features. The device may also include a locking mechanism configured to lock the axial and rotational position of the anchoring mechanism relative to the flow optimizer. The locking mechanism may include one or more screws configured to extend through the core and engage the shaft.

[0022] In general, in one embodiment, a device for assisting tricuspid valve function of the heart includes a shaft, a flow optimizer fixedly connected to the distal end region of the shaft, and an anchoring mechanism connected to the proximal end region of the shaft. The anchoring mechanism includes a core and a plurality of arms extending radially from the core. A first arm of the plurality of arms is fixedly attached to the core, and a second arm of the plurality of arms is rotationally attached to the core. The second arm is configured to move along a cam surface to set the angular arrangement of the second arm relative to the first arm.

[0023] This and other embodiments may include one or more of the following features. The device may also include a locking mechanism configured to lock the angular arrangement of the second arm relative to the first arm. The locking mechanism may include one or more screws.

[0024] This and other embodiments may include one or more of the following features. Each arm may be configured to be placed at the commissure of the tricuspid valve. The plurality of arms may further include a third arm, and the third arm may be configured to move along the cam surface to set the angular arrangement of the third arm relative to the first arm and the second arm.

[0025] In general, in one embodiment, a device for implantation includes a shaft, a flow optimizer fixedly connected to the shaft, and an anchoring mechanism. The anchoring mechanism includes a plurality of arms including a curved elongated element and a covering positioned on a distal end of the elongated element.

[0026] This embodiment and other embodiments may include one or more of the following features. The covering may include polyethylene terephthalate. The covering may extend around only the outer 10%-40% of the arm. The arm may include metal. The covering may include a cushion and a sleeve. The cushion may include 3-10 layers of fabric. Each arm may be configured to be placed at the commissure of the tricuspid valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In particular, the novel features of the present invention are set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments utilizing the principles of the present invention, wherein:

[0029] Figure 1A is a side perspective view of a valve support device.

[0030] Figure 1B yes Figure 1A Top view of a valve support device.

[0031] Figure 2 is a side view of a valve support device showing exemplary dimensions.

[0032] Figure 3 is a side view of a valve support device with exemplary defined angles.

[0033] Figure 4A yes Figure 1A-1B A perspective view of a valve support device with one anchoring arm removed for clarity.

[0034] Figure 4B yes Figure 1A-1B Cross-sectional view of a valve support device.

[0035] Figure 4C yes Figure 1A-1B Another cross-sectional view of a valve support device.

[0036] Figure 5A yes Figure 1A-1B Another cross-sectional view of a valve support device.

[0037] Figure 5B yes Figure 1A-1B A perspective view of a valve support device of , without the leaflets for clarity.

[0038] Figure 6 yes Figure 1A-1B Another perspective view of a valve support device of , without the leaflets for clarity.

[0039] Fig. 7A is a side perspective view of another valve support device.

[0040] Figure 7B yes Fig. 7A Top view of a valve support device.

[0041] Figure 7C yes Fig. 7A Cross-sectional view of a valve support device.

[0042] Fig. 8A yes Fig. 7A A cross-sectional view of a valve support device in which the flow optimizer is tilted relative to the anchoring assembly.

[0043] Figure 8B yes Fig. 8A Side perspective view of a valve support device.

[0044] Figure 8C yes Fig. 8A A top perspective view of a valve support device.

[0045] Fig.9A is a perspective view of a valve support device with a covering on the outer ends of the anchoring arms.

[0046] Fig. 9B yes Fig.9A A close-up view of the outer ends of the anchoring arms of the device.

[0047] Fig. 10A is a perspective view of a flow optimizer with multi-layer leaflets in an expanded configuration.

[0048] Fig. 10B Shows Fig. 10A The top layer of the leaflet.

[0049] Fig. 10C Shows Fig. 10B The bottom layer of the leaflet.

[0050] Fig.11A yes Fig. 10A A perspective view of the flow optimizer, with the top layer compacted and the bottom layer expanded.

[0051] Fig. 11B yes Fig.11A Top view of the flow optimizer.

[0052] Fig. 11C yes Fig.11A Bottom view of the flow optimizer.

[0053] Fig. 12A is a perspective view of a flow optimizer with the leaflets sutured to the frame in a first suture pattern.

[0054] Fig. 12B is a perspective view of the flow optimizer with the leaflets sutured to the frame with a second suture pattern.

[0055] Fig.13A The pattern used to cut the top layer of the leaflet is shown.

[0056] Fig. 13B The pattern used to cut the bottom layer of the leaflet is shown.

[0057] Fig.14A is a perspective view of a flow optimizer with a single-layer leaflet.

[0058] Fig. 14B Shows Fig.14A The leaflets of the flow optimizer.

[0059] Fig.15A The distal tip of the anchoring arm of the valve support device is shown with a cushion thereon (the outer sheath is removed for clarity).

[0060] Fig. 15B Shown with a sleeve thereon Fig.15A distal end of .

[0061] Fig.16A is a cross-sectional view of the proximal end of a valve support device with the annular lock in a proximal (unlocked) configuration.

[0062] Fig. 16B yes Fig.16A A perspective view of a valve support device of with the annular lock in a proximal position and the flow optimizer tilted relative to the anchoring mechanism.

[0063] Fig. 16C yes Fig.16A Cross-sectional view of a valve support device with the annular lock in a distal (locked) configuration.

[0064] Fig.16D yes Fig.16A A perspective view of a ring lock of a device.

[0065] Fig.17A is a cross-sectional view of the proximal end of a valve support device with the annular lock in a proximal (unlocked) configuration.

[0066] Fig. 17B yes Fig.17A A perspective view of a valve support device of FIG. 1 with the annular lock in a proximal configuration.

[0067] Fig. 17Cyes Fig.17A Cross-sectional view of a valve support device with the annular lock in a distal (locked) configuration.

[0068] Fig.17D yes Fig.17A A perspective view of a valve support device of FIG. 1 with the annular lock in a distal configuration.

[0069] Fig.17E yes Fig.17A A perspective view of a ring lock of a device.

[0070] Detailed Description

[0071] This article describes a catheter-delivered intracardiac implant for supporting and improving tricuspid valve function. A tricuspid valve implant (also referred to as a tricuspid valve support device) may include a flow optimizer and / or an anchor, one or both of which may be configured to accommodate anatomically and hemodynamically challenging positions within the tricuspid valve. For example, the flow optimizer may be configured so that during the diastolic phase of the cardiac cycle, the flow optimizer minimizes its cross-sectional area and allows hemodynamic flow to pass around and through the implant, thereby minimizing the potential risk of inducing atrioventricular pressure gradients and thrombosis. During the systolic phase, the flow optimizer may be expanded to seal or minimize the regurgitation orifice and restore the efficacy of the tricuspid valve. In addition, for example, the anchor may be configured to anchor the implant near the tricuspid valve without the need for traumatic interaction with the tricuspid valve, right atrium, or right ventricle. The implant may allow the position of the flow optimizer within the natural tricuspid valve to be adjusted during standard imaging techniques (e.g., fluoroscopy, echocardiography), thereby providing real-time optimization of hemodynamic flow across the tricuspid valve. The implants described herein may advantageously increase the efficacy, safety, and procedural success rate of transcatheter treatment of tricuspid regurgitation.

[0072] The flow optimizer can be placed in the lumen of the tricuspid valve and can allow diastolic hemodynamic flow to flow from the right atrium into the right ventricle and, during systole, reduce or prevent blood from flowing back from the right ventricle to the right atrium. The flow optimizer can be placed in the tricuspid valve on the ventricular side (distal or bottom side). The anchor to which the flow optimizer can be directly connected can engage the tricuspid annulus at the commissure of the natural leaflets. Anchoring can be achieved from the atrial side (proximal or apical side). In some embodiments, the device can be anchored in the right atrium at the commissure. When implanted in the tricuspid valve, the device can seal the docking gap between the natural leaflets during the systolic phase of the cardiac cycle and allow blood to flow from the right atrium to the right ventricle during the diastolic phase of the cardiac cycle.

[0073] The tricuspid valve support device described herein can be used to reduce or prevent tricuspid valve regurgitation. The device can be configured to adopt a crimped structure so as to be deployed using a standard intravascular catheter. In addition, the device can be configured to adopt an expanded configuration when placed in the body.

[0074] Although shown and described with reference to the tricuspid valve, the device, flow optimizer and / or anchoring mechanism may be adapted for use in any valve of the heart.

[0075] Figure 1A-1B The tricuspid valve support device 500 is shown in an expanded configuration (with the leaflets expanded). The device 500 is configured to be anchored on the tricuspid valve annulus. The device 500 includes an anchoring mechanism 510 and a flow optimizer 540 connected to a shaft 519.

[0076] The anchoring mechanism 510 includes a plurality of arms 515a-515c that surround and are radially disposed from an inner core 521 of the device 500. The contour of the end regions (or distal end regions) 526 of the arms 515a-515c can match the tissue wall of the tricuspid annulus at the commissure of the natural leaflets. The middle portion 517 of the arms 515a-515c can be shaped to conform to the inner upper annular wall of the right atrium to provide further support and / or stability. The arms 515a-515c can be made of, for example, a shape memory material, such as nitinol, so as to be compacted for delivery and to self-expand outwardly to conform to the anatomical structure of the tricuspid valve. When deployed in the tricuspid valve, the end regions 526 of the arms 515a-515c can mate with the tissue walls of the tricuspid annulus at the commissures of the leaflets and the middle portion 517 can rest against the inner upper annular wall of the right atrium to provide further hold and stability to the tricuspid flow optimizer 540. Figure 2 2 shows exemplary dimensions and angles of arm 515 (which may be any of arms 515a-515c). The specific shapes of arms 515a-515c are exemplary, and it should be understood that other shapes and corresponding dimensions and angles are possible. For example, Figure 3 Arm 315 is shown extending at wider angles α and β relative to the longitudinal axis 333 of the device than arm 515 .

[0077] refer to Figure 4A-4C, one or more arms 515a-515c of the anchoring mechanism 510 of the device 500 can be configured to rotate around the internal core 521. In one embodiment, one arm (515a) can remain fixed relative to the internal core 521, while the other two arms (515b, 515c) can rotate independently clockwise or counterclockwise relative to the internal core 521. For example, the fixed arm 515a can have a cylindrical proximal portion 516a, which can be fixed to the internal core 521, for example, via a snap-fit ​​mechanism. The second arm 515b can have a proximal portion 516b that slides circumferentially along the cam surface 532b on the internal core 521. Similarly, the third arm 515c can have a proximal portion 516c that slides circumferentially along the second cam surface 532c on the internal core 521. Once arms 515b, 515c have reached their desired circumferential positions, arms 515b, 515c can be locked in place individually via starting screws 522b, 522c. For example, screw 522c can be configured to extend through the threaded hole 541c in the inner core 521. When screw 522c extends out from hole 541c distally, it can engage with the wavy proximal edge 517c of proximal portion 516c. In certain embodiments, engagement with this wavy edge 517c can prevent arm 515c from moving. In other embodiments, screw 522c can extend between inner core 521 and proximal portion 516c to force proximal portion 516c to abut against the cylindrical proximal portion 516a of fixed arm 515a, thereby preventing arm 515c from moving due to friction. Screw 522b can similarly lock arm 515b in place.

[0078] By rotating arms 515b, 515c, an operator can advantageously position arms 515b-515c at different relative angles relative to arm 515a, respectively, to match the angle of the commissures of the leaflets of the patient's native tricuspid valve. Rotation and locking of arms 515b-515c can be performed pre-procedurally (e.g., prior to loading device 500 into a delivery catheter) and / or during the procedure.

[0079] refer to Figure 5A-Figure 5B, the shaft 519 fixed to the flow optimizer 540 can be configured to slide axially and / or rotate relative to the anchoring mechanism 510 to provide axial and rotational adjustment of the relative position of the anchoring mechanism 510 and the flow optimizer 540 in the device 500. For example, the shaft 519 can slide or rotate within the central lumen 551 of the inner core 521. The lip 553 on the proximal end of the shaft 519 can be configured to abut the proximal end 555 of the inner core 521 to prevent the flow optimizer 540 from completely disengaging from the anchoring mechanism 510. In addition, once the flow optimizer 540 and the anchoring mechanism 510 are in the desired relative position, the flow optimizer 540 and the anchoring mechanism 510 can be locked in position relative to each other via the start screw 523. The screw 523 can engage with (and rotate in) the threaded hole 557 in the inner core 521. The threaded hole 557 can extend at a certain angle relative to the longitudinal axis of the device (e.g., at an angle of 30 degrees to 45 degrees). When the screw 523 moves into engagement with the shaft 519 , the screw 523 may push the shaft 519 against the inner core 521 , thereby preventing the shaft 519 from moving relative to the inner core 521 via friction.

[0080] Axial and rotational positioning of the flow optimizer 540 relative to the anchoring mechanism 510 can be performed pre-procedurally (e.g., prior to loading the device 500 into a delivery catheter) and / or during the procedure. Advantageously, when performed while the device 500 is in place within the body, the axial position can be set without the need for rotation of the flow optimizer 540, thereby reducing unnecessary interaction with and / or grabbing of native anatomy. Additionally, the rotational position of the flow optimizer 540 relative to the anchoring mechanism 510 can advantageously be specifically set via the rotation axis 519 (e.g., once the device 500 is in place within the body), thereby allowing precise positioning of the flow optimizer 540 relative to the native tricuspid valve and optimization of its position relative to the regurgitant orifice.

[0081] Return to reference Figure 1A , the flow optimizer 540 may include a frame 545 supporting leaflets 550 that expand radially during systole (eg, Figure 1A 510 and radially contract toward the central axis during diastole. The frame 545 may include a plurality of convex arms extending from the shaft 519. The convex arms may ensure that the flow optimizer 540 maintains a substantially convex cup shape when expanded. This may advantageously ensure that there is no blood pool between the anchoring mechanism 510 and the flow optimizer 540 during systole. In addition, as shown in FIG. Figure 6 As shown, the distal end 561 of the shaft 519 can have a detent cut therein to avoid interaction with the contracted leaflets 550 during diastole.

[0082] During diastole, when blood flows from the right atrium through the tricuspid valve into the right ventricle under atrial contraction, the atrioventricular hemodynamic pressure gradient opens the tricuspid valve leaflets (similar to Figures 7A-8C ). The atrioventricular hemodynamic pressure gradient can cause the leaflets 550 of the flow optimizer 540 to contract toward the central axis of the frame 545, thereby reducing the three-dimensional volume and cross-sectional area of ​​the flow optimizer 540, thereby allowing blood to flow unrestricted into the ventricle around the flow optimizer 540. During systole (i.e., ventricular contraction), when the tricuspid valve leaflets converge around the flow optimizer 540, the ventricular hemodynamic pressure can cause the leaflets 550 to expand to all or part of their three-dimensional volume, which is sufficient to close the tricuspid valve regurgitation orifice and reduce or prevent blood flow into the right atrium.

[0083] Advantageously, device 500 can ensure that the pressure gradient across the tricuspid valve after implantation remains low, such as less than 3 mmHg or less than 2 mmHg.

[0084] Device 500 may be loaded into, for example, an intravascular catheter and delivered to the right atrium and into the tricuspid valve via femoral access through the IVC or via right internal jugular access through the IVC.

[0085] Another embodiment of the tricuspid valve support device 700 is Figures 7A-8C 7 is shown in an expanded configuration (and with the leaflets contracted). Support device 700 is similar to support device 500 and includes an anchoring mechanism 710 having a plurality of arms 715a-715c that surround and are radially disposed from an inner core 721 (and that can be locked with screws 722b, 722c). In addition, shaft 719 secured to flow optimizer 740 can be configured to slide axially and rotate axially relative to anchoring mechanism 710 (similar to device 500), and the leaflets of the flow optimizer can expand and contract during systole and diastole, respectively.

[0086] However, unlike device 500, the shaft 719 and flow optimizer 740 of device 700 are also configured to be adjustably positioned off-axis relative to the anchoring mechanism 710 (i.e., can be configured to be tilted). Such tilt adjustment can allow for precise angular positioning of the flow optimizer 740 relative to the native tricuspid valve. In order to make the angular positioning of the flow optimizer 740 adjustable, the device 700 (e.g., the core 721) includes a ball 771 positioned within a socket 773. The ball 771 includes an inner cavity 775 through which the shaft 719 extends, and the shaft 719 can slide or rotate within the central inner cavity 775. In addition, the ball 771 can rotate within the socket 773, thereby allowing the flow optimizer 740 to be placed off-axis relative to the anchoring mechanism 710 (see Figure 7B). Figure 8A-8C). The angled flange on the inner cavity 751 of the core 721 can prevent the flow optimizer 740 from extending at too large an angle relative to the anchoring mechanism 710 (for example, the angle of the axis of the anchoring mechanism 710 relative to the axis of the flow optimizer 740 can be limited to less than 45 degrees, such as less than 35 degrees, such as less than 25 degrees).

[0087] Once the flow optimizer 740 and the anchoring mechanism 710 are in the desired relative position, the flow optimizer 740 and the anchoring mechanism 710 can be locked in position relative to each other via the start screws 777, 779. The screws 777, 779 can engage with (and rotate in) the threaded holes in the inner core 721. The threaded holes can extend at an angle relative to the longitudinal axis of the device (e.g., at an angle of 5 degrees to 45 degrees, such as 10 degrees to 30 degrees). The screws 777, 779 can be configured to extend through the orifice until they engage with the ball 771. When engaged by a first amount, the position of the ball 771 can be fixed, thereby fixing the angular position of the anchoring mechanism 710 relative to the flow optimizer 740. Under this first amount, the shaft 719 can still be allowed to move (e.g., axial sliding and axial rotation) in the inner cavity 775 (e.g., for axial positioning or rotational positioning of the flow optimizer 740 relative to the anchoring mechanism 710). When the screw 777 is tightened by a second additional amount, the ball 771 can push against the shaft 719 and thereby prevent the shaft 719 from moving within the lumen 775 and fix the axial and rotational position of the flow optimizer 740 relative to the anchoring mechanism 710 .

[0088] Figures 16A-16D Another embodiment of a tricuspid support device 1600 is shown. Similar to device 700, device 1600 includes a shaft 1619 and a flow optimizer 1640, which are configured to be positioned off-axis relative to the anchoring mechanism 1610 (i.e., can be configured to be tilted). Like device 700, device 1600 includes a ball 1671 positioned within a socket 1673. However, unlike device 700, device 1600 includes an annular lock 1662 that is configured to fit within an inner core 1621. The annular lock 1662 may include a threaded groove 1664 along its outer side, which is configured to engage with a threaded groove 1666 on the inner surface of the inner core 1621. In use, the annular lock 1662 can be positioned in a proximal configuration (such as Figure 16A-16B1662) so that the flow optimizer 1640 is free to tilt relative to the anchoring mechanism 1610. Once the flow optimizer 1640 and the anchoring mechanism 1610 are in the desired relative position, the flow optimizer 1640 and the anchoring mechanism 1610 can be locked in position relative to each other via activation of the annular lock 1662. To this end, the annular lock 1662 can be rotated within the inner core 1621, causing the annular lock 1662 to move distally toward the ball 1671 and enter the distal configuration (as shown). Fig. 16C 1675 ). When engaged with ball 1671 by a first amount, the position of ball 1671 can be fixed, thereby fixing the angular position of anchoring mechanism 1610 relative to flow optimizer 1640. At this first amount, shaft 1619 can still be allowed to move (e.g., axially slide and axially rotate) within lumen 1675. When annular lock 1662 is further rotated distally, ball 1671 can push against shaft 1619 and thereby prevent shaft 1619 from moving within lumen 1675 and fix the axial and rotational position of flow optimizer 1640 relative to anchoring mechanism 1610.

[0089] Figure 17A-17E Another embodiment of the proximal end of a tricuspid valve support device 1700 is shown. Similar to device 1600, device 1700 includes an annular lock 1762 to lock the tilted position of the flow optimizer relative to the anchor assembly. Unlike annular lock 1662, annular lock 1762 can be a snap-fit ​​lock (rather than a screw lock). Figure 17A-17B As shown, the annular lock 1762 can be positioned in a proximal configuration, wherein the lock 1762 is not engaged with the ball 1761, and the shaft 1719 is free to tilt (and / or axially rotate or axially move). Figure 17C-Figure 17D As shown, the annular lock 1762 can be pushed distally (ie, rather than rotated) to a distal configuration in which the lock 1762 engages the ball 1761 to lock the position of the shaft 1719.

[0090] Advantageously, the adjustability of the arms of the anchoring mechanisms described herein (e.g., shape and rotational position) combined with the adjustability of the position of the anchoring mechanisms relative to the flow optimizers described herein (e.g., rotational, angular, and / or axial) provide for precise alignment of the device relative to the native tricuspid valve. The device can be fully integrated with the tricuspid valve and annulus, moving harmoniously and ergonomically during both systolic and diastolic phases without obstructing the atria or ventricles. Furthermore, such adjustability can be performed in real time by the operator, allowing for immediate evaluation and adjustment prior to permanent implantation of the device, thereby improving treatment outcomes. Similarly, the amount of sealing (partial or complete) within the tricuspid valve provided by the flow optimizer described herein can be adjusted during the procedure (via tilt, rotational, and axial adjustment of the flow optimizer relative to the anchoring mechanism) and can be based on an evaluation or monitoring of the patient's RV function and pulmonary artery pressure.

[0091] refer to Figure 9A-9B In some embodiments, the anchoring arms 915a-915c (e.g., arms 515a-515c and 715a-715c) of any device described herein may include a covering 991 on its outer end. The covering 991 may be made of, for example, polyethylene terephthalate fabric. In some embodiments, the covering 991 may extend only around the outer portion of the arms 915a-915c, such as along the outer 10%-40%, such as 25%-35%, of the arms 915a-915c. The covering 991 may advantageously enhance endothelial growth and subsequent encapsulation of the outer ends of the arms 915a-915c (e.g., at the ring). The remainder of the arms 915a-915c may remain uncovered, thereby helping to prevent thrombosis during use.

[0092] refer to Figure 15A-15B In some embodiments, the cover 1591 (e.g., cover 991) may include a pad 1552 and a sleeve 1554. The pad 1552 may, for example, extend only at the distal end of each arm 1515, such as extending along the portion of the arm 1515 that hooks backward (e.g., within the outer 10% of the arm 1515). The sleeve 1554 may be placed over the pad 1552 and the arm 1515, and may extend the entire length of the cover 1591. The pad 1552 may advantageously help to make the end of the arm 1515 atraumatic. In some embodiments, the pad 1552 may be made of multiple layers of fabric sealed together, such as 3-10 layers of fabric, such as 4-8 layers of fabric. For example, the pad 1552 may be made of layers of polyethylene terephthalate (PET) fabric. In some embodiments, the pad 1552 may be made of a single piece of foam.

[0093] The leaflets used for any device described herein can be made of a material that is impermeable to blood cells, and preferably a material that is impermeable to blood fluids (e.g., aqueous solutions). For example, the leaflets can be formed of any suitable biocompatible material, including, for example, woven or nonwoven polymer fabrics or sheets and / or biological tissues harvested from animals (e.g., cattle, pigs, and horses) or humans. Suitable biological tissues include, for example, tissues obtained from the pericardial sac of donor animals and / or humans. In some embodiments, the leaflets can be made of composite polymer materials. Composite materials can be made of two-dimensional woven (or braided or knitted) fabrics (e.g., PET fabric sheets) or three-dimensional thermoformed fabrics (e.g., PET fabric shapes). The fabric layer can advantageously carry the cyclic fatigue loads imposed on the leaflets by the hemodynamic flow of the cardiac cycle. The multi-porosity of the fabric can be designed to allow it to be coated with a biocompatible and anti-thrombotic coating, such as polyurethane (PU) or polyurethane-silicone (PU-Sil), without significantly affecting the flexibility of the fabric. In some embodiments, the coating can be applied to the fabric in liquid form using standard coating manufacturing processes (i.e., dipping, spraying, electrospinning). The coating can completely cover the fabric and isolate the fabric from the blood flow. In some embodiments, the final composite material (e.g., PET+PU or PET+PU-Sil) can provide high fatigue resistance due to the woven fabric substrate and strong chemical stability due to the coating.

[0094] The leaflets can be sewn or attached to the arms of a frame (e.g., frame 545) using other standard fastening methods (e.g., adhesive). Additionally and / or alternatively, the leaflets can be molded into the desired three-dimensional shape as a single subassembly that can be mounted on a frame.

[0095] refer to Figure 10A-10C In some embodiments, the leaflets 1050 of the device 1000 (which can be any leaflet described herein) can be composed of two circumferential layers. That is, each leaflet can have a top layer 1011 (positioned toward the apex 1015 at the atrial end of the frame 1045) and a bottom layer 1013 (positioned toward the end or tip of the convex frame arm at the ventricular end of the frame 1045). The shape of the top layer 1011 can be substantially triangular, while the shape of the bottom layer 1013 can be substantially rectangular or quadrilateral. The layers 1011, 1013 can be a radially overlapping configuration, with the bottom layer 1013 positioned radially outward of the top layer 1011. During heart contraction, the leaflets 1050 can be substantially convex (e.g., Fig. 10A ), and layer 1011 and layer 1013 may be sealed against and / or in contact with each other.

[0096] like Figure 10B-Figure 10CAs shown, each individual leaflet layer 1011, 1013 may include an edge 1017 and a membrane 1019. The membrane 1019 may include a thin layer of a polymer material, such as polyurethane-silicone. The edge 1017 of the top layer 1011 may extend along the first edge 1014a and the second edge 1014b (closest to the apex 1015), while the third edge 1014c (the most ventricular edge) has no edge. Similarly, the edge 1017 of the bottom layer 1013 may extend along the first edge 1016a, the second edge 1016b and the third edge 1016c, while leaving the fourth edge 1016d (the most ventricular edge) without an edge. The edge 1017 may be made of, for example, a fabric, such as a polyethylene terephthalate fabric. In some embodiments, the edge 1017 may have a coating thereon, such as a polyurethane and / or silicone coating. In addition, the edge 1017 may be thicker and / or have greater rigidity than the membrane 1019.

[0097] refer to Figure 11A-11C During diastole, as blood flows from the right atrium into the right ventricle, the hemodynamic pressure gradient may cause the leaflets 1050 of the device 1000 to contract and / or become concave toward the central axis of the frame 1045 (the concave leaflets 1050 are Fig.11A As shown in Figure 11B-Figure 11C As shown, because the overlapping layers 1013, 1011 have varying stiffnesses (i.e., due to the location and size of the edge 1017), the top layer 1011 can contract first, thereby leaving a gap 1018 between the top layer 1011 and the bottom layer 1013. That is, the stiffness of the edge 1017 along the edges 1016a, 1016b, 1016c of the bottom layer 1013 can hold the bottom layer 1013 radially outward longer than the edgeless overlapping bottom edge 1014c of the top layer 1011. Moving the layers 1011, 1013 sequentially (e.g., the top layer 1011 moves radially inward before the bottom layer 1013) can allow blood to flow through the gap 1018, minimize potential areas of blood stagnation, and thus prevent thrombus formation around or in the leaflets 1050. Additionally, sequential deflation can help minimize obstruction of atrial-ventricular flow during the diastolic phase by reducing the effective orifice area (e.g., can help maintain a gradient of less than 3 mmHg, such as less than 2 mmHg after implantation). In other embodiments, the top layer 1011 and bottom layer 1013 can be configured to deflate simultaneously.

[0098] refer to Figure 12A-12B , the leaflet 1250 (which may be any leaflet described herein) may be arranged along an edge (e.g., along Figure 10A-10CThe edges 1014b, 1014c and the edges 1017 of 1016a, 1016b, 1016c are sutured to the frame 1245. The sutures can be parallel to the edges, which can advantageously reduce the impact on blood flow and reduce the risk of thrombosis. In some embodiments, the sutures can be positioned by pre-drilled (e.g., laser cut) holes to ensure alignment of the components when sutured together. The sutures can be wrapped around the arms of the frame 1245 (e.g., Fig. 12A ), or extending only in a direction parallel to the arms of frame 1256 (as shown Fig. 12B shown).

[0099] refer to Figure 13A-13B , an exemplary method of manufacturing a leaflet comprises:

[0100] 1) Obtain a panel 1331, such as a polyethylene terephthalate fabric coated with polyurethane and silicone. The panel 1331 may be, for example, 40 microns thick.

[0101] 2) Place the panel 1331 on a tray, such as a borosilicate glass tray.

[0102] 3) Change the pattern of the top leaflet (such as Fig.13A as shown) laser cut into panel 1331.

[0103] 4) Remove the center portion of the top blade from panel 1331, leaving only the edge 1317.

[0104] 5) Repeat steps 1-4 for the bottom leaflet (with patterned panel 1332 at Fig. 13B ).

[0105] 6) Coat the entire surface of panels 1331, 1332, including the cutouts, with a coating such as polyurethane and silicone. The coating can be, for example, 20 microns thick. The coating can form a film between edges 1317.

[0106] 7) Repeat step 6, applying additional coats as desired to achieve the desired edge and film thickness.

[0107] 8) Cut the completed leaflets from panels 1331 and 1332.

[0108] refer to Figure 14A-14B, in some embodiments, the leaflets 1450 (which may be used as part of any flow optimizer described herein) may be comprised of a single circumferential layer. Each leaflet 1450 may have a substantially triangular shape. In addition, each leaflet 1450 may have an edge 1417 and a membrane 1419 as described above with respect to the leaflets 1050. Similar to the top layer 1011, the edge 1417 may extend along the first edge 1414a and the second edge 1414b (toward the apex 1415), while leaving the third edge 1414c (the ventricular-most edge) without an edge. The leaflets 1450 may be manufactured using the same process as described above with respect to the dual circumferential layers of the leaflets, except for step 5 (i.e., not manufacturing the bottom leaflet). In use, during diastole, as blood flows from the right atrium into the right ventricle, the hemodynamic pressure gradient causes the leaflets 1450 to contract toward the central axis of the frame 1445. Because membrane 1419 is thinner than edge 1417 (e.g., the thickness of the membrane is less than 75% of the thickness of the edge, such as less than 60% of the thickness of the edge, such as less than 55% of the thickness of the edge, such as less than or equal to 50% of the thickness of the edge), membrane 1419 can advantageously rapidly contract during diastole (and similarly rapidly expand during systole).

[0109] In some embodiments, during diastole, the ratio of the cross-sectional area of ​​the device relative to the tricuspid annulus area can be less than 0.4, such as less than 0.3, such as less than or equal to 0.26. Having a low cross-sectional area ratio relative to the tricuspid annulus can advantageously help ensure that the pressure gradient across the valve remains low (such as less than 3 mmHg or less than 2 mmHg).

[0110] In some embodiments, some or all of the devices described herein may be echogenic and / or radiopaque, allowing for intraprocedural visualization.

[0111] Advantageously, the devices described herein can be placed even in the presence of pacemaker leads. Additionally, the devices described herein can allow for the crossing of assist devices from the right atrium to the right ventricle without interfering with device function.

[0112] In some embodiments, an extended flow optimizer as described herein may be substantially circular or elliptical (or convexly triangular) in cross-section, while an unextended flow optimizer may be triangular (or concavely triangular) in cross-section.

[0113] The devices described herein may additionally or alternatively include any of the features described in PCT Publication No. WO2018 / 119192, entitled “Heart Valve Support Device and Methods for Making and Using the Same,” the entire contents of which are incorporated herein by reference.

[0114] It should be understood that the devices and methods described herein may be used additionally or alternatively to the tricuspid valve for use with other heart valves, such as the mitral valve or the aortic valve.

[0115] When a feature or element is referred to as being "on" another feature or element in this article, it may be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly on another feature or element", there is no intermediate feature or element. It will also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will also recognize that the structure or feature of the "adjacent" another feature setting involved may have a part overlapping with the adjacent feature or below the adjacent feature.

[0116] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to also include the plural forms, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any combination and all combinations of one or more of the associated listed items, and may be abbreviated as " / ".

[0117] Spatially related terms such as "under", "below", "lower", "over", "upper", etc. may be used herein for ease of description to describe the relationship of one element or feature to other elements or features as shown in the accompanying drawings. It will be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is reversed, the elements described as "below other elements or features" or "below other elements or features" will be oriented to "on the other elements or features". Therefore, the exemplary term "below" may include both "on" and "below". The device may be oriented otherwise (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes.

[0118] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0119] In this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components can be used together in methods and articles of manufacture (e.g., compositions and apparatus including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0120] As used herein in the specification and claims, including as used in the examples and unless expressly stated otherwise, all numbers may be treated as if they were preceded by the word "about" or "approximately," even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing a magnitude and / or position to indicate that the value and / or position being described is within a reasonably expected range of values ​​and / or positions. For example, a numerical value may have a value of + / -0.1% of a set value (or range of values), + / -1% of a set value (or range of values), + / -2% of a set value (or range of values), + / -5% of a set value (or range of values), + / -10% of a set value (or range of values), etc. Any numerical range stated herein is intended to include all subranges contained therein.

[0121] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0122] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and if in fact more than one is disclosed, it is not intended that the scope of the present application is actively limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, those skilled in the art will understand the combination of the above embodiments and other embodiments not specifically described herein.

Claims

1. A device for assisting the tricuspid valve function of a heart, comprising: axis; a flow optimizer fixedly connected to the distal end of the shaft; an anchoring mechanism including a core having a socket therein; as well as A ball is positioned within the socket, the ball having an interior cavity therein, the shaft being configured to extend through the interior cavity, wherein the ball is configured to rotate within the socket to tilt the shaft relative to a central axis of the anchoring mechanism.

2. A device for assisting the tricuspid valve function of a heart, comprising: axis; a flow optimizer fixedly connected to a distal end region of the shaft; an anchoring mechanism including a core having a socket therein; as well as A rotational element is positioned within the socket, the rotational element having an internal cavity therein, the shaft being configured to extend through the internal cavity, wherein the rotational element is configured to rotate within the socket to tilt the shaft relative to a central axis of the anchoring mechanism.

3. The device according to claim 1 or 2, wherein: The shaft is configured to slide axially and rotate within the lumen.

4. The device according to claim 1 or 2, wherein: The core includes an angled flange configured to limit an angle of the flow optimizer relative to the anchoring mechanism.

5. The device according to claim 4, wherein: The angle is less than 45 degrees.

6. The apparatus of claim 1, further comprising a locking mechanism configured to lock a tilt angle of the flow optimizer relative to the anchoring mechanism.

7. The device according to claim 6, wherein: The locking mechanism is also configured to lock the axial and rotational position of the flow optimizer relative to the anchoring mechanism.

8. The device according to claim 6, wherein: The locking mechanism includes one or more screws configured to extend through the core and engage the ball.

9. The device according to claim 7, wherein: The locking mechanism includes an annular lock configured to fit between the core and the ball.

10. The device according to claim 9, wherein: The annular lock is configured to move axially between a proximal position and a distal position, the ball is configured to rotate in the proximal position, and the ball is fixed in the distal position.

11. The device according to claim 9, wherein: The annular lock is a snap-fit ​​lock.

12. The device according to claim 9, wherein: The annular lock includes a threaded groove configured to mate with a threaded groove on an inner surface of the core.

13. The device according to claim 1 or 2, wherein: The flow optimizer includes a frame and a plurality of leaflets attached to the frame.

14. The device according to claim 13, wherein: The plurality of leaflets are configured to expand to an expanded configuration during systole to block blood flow around the flow optimizer and to contract to a contracted configuration during diastole to allow blood flow around the flow optimizer.

15. The device according to claim 1 or 2, wherein: The anchoring mechanism also includes a plurality of anchoring arms extending radially away from the core.

16. A method for assisting tricuspid valve function of the heart, comprising: inserting a tricuspid valve device into a native tricuspid valve, wherein the tricuspid valve device comprises a shaft, a flow optimizer, and an anchoring mechanism; securing the anchoring mechanism at the commissure leaflets of the native tricuspid valve; and The shaft is tilted relative to a central axis of the anchoring mechanism to position the flow optimizer at a desired angular position within the native tricuspid valve.

17. The method according to claim 16, wherein: Tilting the axis includes rotating a ball within a socket of the tricuspid valve device.

18. The method according to claim 16, further comprising: during diastole, reducing a cross-sectional area of ​​the flow optimizer to allow hemodynamic flow around and through the flow optimizer; as well as During systole, the cross-sectional area of ​​the flow optimizer is increased to seal the orifice of the native tricuspid valve.

19. The method of claim 16, further comprising, after securing the anchoring mechanism, axially moving the shaft relative to the anchoring mechanism to position the flow optimizer at a desired axial position within the native tricuspid valve.

20. The method of claim 16, further comprising rotating the shaft relative to the anchoring mechanism after securing the anchoring mechanism to position the flow optimizer in a desired rotational position within the native tricuspid valve.

21. The method of claim 17, further comprising locking the flow optimizer in the desired angular position with a locking mechanism.

22. The method according to claim 21, wherein: The locking mechanism also locks the axial and rotational position of the flow optimizer relative to the anchoring mechanism.

23. The method according to claim 21, wherein: The anchoring mechanism includes a core, and the locking mechanism includes one or more screws configured to extend through the core and engage the ball.

24. The method according to claim 21, wherein: The locking mechanism includes an annular lock configured to fit around the shaft.

25. The method according to claim 24, wherein: Locking includes moving the annular lock distally relative to the anchoring mechanism.

26. The method according to claim 25, wherein: Locking includes rotating the annular lock relative to the anchoring mechanism.

27. A device for assisting the tricuspid valve function of a heart, comprising: axis; Anchoring institutions; a flow optimizer fixedly connected to the shaft and comprising: a frame having a plurality of arms; and a plurality of leaflets attached to the plurality of arms; wherein the plurality of leaflets are configured to expand to an expanded configuration during systole to block blood flow around the flow optimizer and to contract to a contracted configuration during diastole to allow blood flow around the flow optimizer, further wherein each leaflet of the plurality of leaflets comprises a membrane and a rim, the rim having a higher stiffness than the membrane, and Wherein the shaft is configured to slide axially and rotationally relative to the anchoring mechanism to adjust the axial and rotational position of the flow optimizer relative to the anchoring mechanism.

28. The apparatus of claim 27, wherein: The plurality of leaflets are also configured to contract to a contracted configuration to allow blood flow through the flow optimizer.

29. The apparatus of claim 27, wherein: The thickness of the membrane is less than 75% of the thickness of the rim.

30. The apparatus of claim 27, wherein: Each of the plurality of leaflets has a substantially triangular shape.

31. The apparatus of claim 27, wherein: Each of the plurality of leaflets includes a first layer and a second layer, the second layer at least partially overlapping the first layer.

32. The apparatus of claim 31, wherein: The first layer is configured to be positioned toward the atrium, and the second layer is configured to be positioned toward the ventricle.

33. The apparatus of claim 32, wherein: The second layer is positioned radially outward of the first layer such that a gap is formed between an atrial end of the second layer and a ventricular end of the first layer.

34. The apparatus of claim 33, wherein: The second layer is substantially quadrilateral in shape, and the first layer is substantially triangular in shape.

35. The apparatus of claim 34, wherein: The rim is located along two edges of the first layer and not along a ventricular end of the first layer, and further wherein the rim is located along three edges of the second layer and not along a ventricular end of the second layer.

36. The apparatus of claim 27, wherein: The leaflet has a first edge, a second edge, and a third edge, the margin being located only along the first edge and the second edge.

37. The apparatus of claim 36, wherein: The first edge and the second edge meet at an apex, and the apex is configured to be closer to the atrium than the third edge.

38. The apparatus of claim 27, wherein: The plurality of leaflets are sutured to the frame using a plurality of sutures extending parallel to the arms of the frame.

39. The apparatus of claim 27, wherein: The rim comprises fabric.

40. The apparatus of claim 39, wherein: The fabric is polyethylene terephthalate.

41. The apparatus of claim 39, wherein: The fabric is coated with polyurethane and silicone.

42. The apparatus of claim 27, wherein: The film comprises a polymer film.

43. The apparatus of claim 40, wherein: The film includes polyurethane and silicone.

44. The device of claim 27, further comprising an anchoring mechanism configured to anchor the device in a native tricuspid valve.

45. The apparatus of claim 44, wherein: The anchoring mechanism includes a plurality of anchoring arms extending radially from the anchoring mechanism.

46. ​​A method of assisting tricuspid valve function of the heart, comprising: implanting a tricuspid valve device into a native tricuspid valve orifice, the tricuspid valve device comprising a shaft, a flow optimizer, and an anchoring mechanism, the flow optimizer comprising a plurality of leaflets, each leaflet having a first layer and a second layer, the first layer and the second layer each comprising a membrane and a rim; tilting the shaft relative to a central axis of the anchoring mechanism to position the flow optimizer at a desired angular position within the native tricuspid valve; During diastole, constricting the plurality of leaflets to allow hemodynamic flow around and through the flow optimizer, wherein constricting the plurality of leaflets comprises moving the first layer radially inwardly before the second layer to create a gap between the first layer and the second layer; and During systole, the plurality of leaflets expand to seal the tricuspid valve orifice.

47. The method of claim 46, wherein: The rim has a higher stiffness than the membrane.

48. The method of claim 46, wherein: The second layer at least partially overlaps the first layer.

49. The method of claim 48, wherein: The first layer is positioned toward the atrium, and the second layer is positioned toward the ventricle.

50. The method of claim 49, wherein: The second layer is positioned radially outward of the first layer such that the gap is formed between an atrial end of the second layer and a ventricular end of the first layer.

51. The method of claim 50, wherein: The second layer is substantially quadrilateral in shape, and the first layer is substantially triangular in shape.

52. The method of claim 51, wherein: The rim is located along two edges of the first layer and not along a ventricular end of the first layer, and further wherein the rim is located along three edges of the second layer and not along a ventricular end of the second layer.

53. The method of claim 46, wherein: Expanding the plurality of leaflets includes closing the gap.

54. A device for implantation, comprising: axis; a flow optimizer fixedly connected to the shaft; as well as Anchoring institutions; Wherein the shaft is configured to slide axially and rotationally relative to the anchoring mechanism to adjust the axial and rotational position of the flow optimizer relative to the anchoring mechanism.

55. The device of claim 54, further comprising a locking mechanism configured to lock the axial and rotational position of the anchoring mechanism relative to the flow optimizer.

56. The apparatus of claim 55, wherein: The anchoring mechanism includes a core, and the locking mechanism includes one or more screws configured to extend through the core and engage the shaft.

57. A device for assisting the tricuspid valve function of the heart, comprising: axis; a flow optimizer fixedly connected to a distal end region of the shaft; An anchoring mechanism connected to the proximal end region of the shaft, wherein the anchoring mechanism includes a core and a plurality of arms extending radially from the core, wherein a first arm of the plurality of arms is fixedly attached to the core, and a second arm of the plurality of arms is rotationally attached to the core, and the second arm is configured to move along a cam surface to set an angular arrangement of the second arm relative to the first arm.

58. The apparatus of claim 57, further comprising a locking mechanism configured to lock the angular arrangement of the second arm relative to the first arm.

59. The apparatus of claim 58, wherein: The locking mechanism includes one or more screws.

60. The apparatus of claim 57, wherein: Each of the arms is configured to be placed at a commissure of the tricuspid valve.

61. The apparatus of claim 57, wherein: The plurality of arms also includes a third arm configured to move along a cam surface to set an angular disposition of the third arm relative to the first arm and the second arm.

62. A device for implantation, comprising: axis; a flow optimizer fixedly connected to the shaft; as well as an anchoring mechanism, wherein the anchoring mechanism comprises a plurality of arms, each of the arms comprising a curved elongated element and a covering positioned on a distal end of the elongated element, Wherein the shaft and the flow optimizer are further configured to be adjustably positioned relative to the anchoring mechanism offset from a central axis of the anchoring mechanism.

63. The device according to claim 62, wherein The cover comprises polyethylene terephthalate.

64. The apparatus of claim 62, wherein: The cover only extends around the outer 10%-40% of the arm.

65. The apparatus of claim 62, wherein: The arm comprises metal.

66. The apparatus of claim 62, wherein: The covering includes a liner and a sleeve.

67. The apparatus of claim 66, wherein: The pad includes 3 to 10 layers of fabric.

68. The apparatus of claim 62, wherein: Each of the arms is configured to be placed at a commissure of the tricuspid valve.

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