Heart valve support device and methods for making and using the same

Abstract

This disclosure relates to a cardiac valve support device and a method for manufacturing and using the device. The device includes a flow optimizer configured to be located within the valve and having a cross-sectional area that reduces the reflux orifice of the valve during cardiac systole. The device includes an anchoring mechanism coupled to the flow optimizer and configured to fix the position of the flow optimizer relative to the valve. The flow optimizer allows for hemodynamic flow during diastole, minimizes the risk of inducing atrioventricular pressure gradients and thrombosis, and seals or minimizes the reflux orifice and restores valve efficacy during cardiac systole. The anchoring system does not require invasive interaction with the valve, atria, or ventricles. Implantation of the device can be achieved without invasive surgery. The device allows for intraoperative optimization of the positioning of the flow optimizer.

Description

[0001] This application is a divisional application of the application filed on December 21, 2017, with application number 201780086306.5, entitled "Heart Valve Support Device and Method for Manufacturing and Using the Device".

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 437,523, filed December 21, 2016. Priority to that provisional patent application is expressly claimed, and the disclosure of that provisional application is incorporated herein by reference in its entirety for all purposes.

[0004] Cross-reference to relevant non-provisional applications

[0005] The following U.S. patent application is wholly owned by the assignee of this application and was filed on the same date as this application. The disclosure of this U.S. patent application is incorporated herein by reference in its entirety for all purposes:

[0006] The submission dated December 21, 2017 was “HEART VALVE SUPPORT DEVICE AND METHODS FORMAKING AND USING THE SAME”.

[0007] field

[0008] The disclosed implementation schemes generally relate to medical device technology, and more specifically, but not exclusively, to heart valve support devices and methods for manufacturing and using such devices. background

[0009] The tricuspid valve (TV) is the atrioventricular valve located on the right side of the human heart, between the right atrium (RA) and right ventricle (RV). The TV's anatomy consists of three asymmetrical leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet, supported by a complex sub-valvular apparatus composed of chordae tendineae and papillary muscles. The TV is also near the Todaro tendon, where the heart's fragile atrioventricular node is located.

[0010] When the tricuspid valve becomes incompetent, regurgitant flow occurs during the systolic phases of the cardiac cycle. This insufficiency is primarily caused by a pathologically induced, gradual enlargement of the valvular annulus, which prevents the leaflets from achieving complete closure during cardiac systole (or the systolic phase of the cardiac cycle). This lack of leaflet closure leads to the formation of a regurgitant orifice within the valve, through which blood can re-enter the right atrium instead of leaving the right ventricle via the pulmonary valve. This condition induces cardiac overload, subsequently leading to enlargement of the right ventricle and right atrium, a decrease in right ventricular stroke volume, and an increase in systemic venous congestion and other symptoms of congestive heart failure. Tricuspid regurgitation can be isolated from or associated with other valvular diseases and contributes to congestive heart failure, resulting in decreased functional cardiovascular capacity and ultimately increasing the risk of death.

[0011] Surgical repair or replacement is the most commonly used technique for treating this pathology, but clinical outcomes (such as mortality and recurrence rates) are not ideal. Furthermore, because most patients affected by tricuspid regurgitation often have several comorbidities, most are not suitable candidates for surgical repair or replacement due to the high risks associated with these procedures.

[0012] Transcatheter ablation does not require open-heart surgery and may be a viable and safer alternative. The unique anatomy of the tricuspid valve presents a major challenge for developing safe and effective implants. Anchoring may require adding load to adjacent cardiac structures (e.g., superior or inferior vena cava, atrioventricular node, coronary sinus, right coronary artery, ventricular myocardium). Furthermore, the low pressure and hemodynamic output on the right side of the heart increase the risk of inducing atrioventricular pressure gradients and thrombosis.

[0013] Overview

[0014] This disclosure relates to a heart valve support device and a method for manufacturing and using the device.

[0015] According to the first aspect disclosed herein, a device for assisting heart valves is described, comprising:

[0016] A flow optimizer, configured to be located at a specific position within the valve and having a cross-sectional area that reduces the valve's reflux orifice during cardiac contraction; and

[0017] An anchoring mechanism is attached to the flow optimizer and configured to fix the position of the flow optimizer relative to the valve.

[0018] In some embodiments of the disclosed device, the cross-sectional area during cardiac contraction is larger than the cross-sectional area during cardiac diastole.

[0019] In some embodiments of the disclosed apparatus, the flow optimizer includes:

[0020] A frame comprising multiple arms, each arm including a first end region and a second end region, the first end regions of the multiple arms being connected at a common joint, and the second end regions extending radially from the common joint; and

[0021] A cover, which is attached to multiple arms and extends between adjacent arms, defines the cross-sectional area of ​​the flow optimizer.

[0022] In some embodiments of the disclosed device, the covering collapses at least partially in the direction of hemodynamic flow during cardiac diastole.

[0023] In some embodiments of the disclosed device, the frame has a conical shape, and the first end regions of the plurality of arms are connected at the central axis of the conical shape.

[0024] In some embodiments of the disclosed device, the conical shape has a base adjacent to the ventricle of the heart and a apex adjacent to the atrium of the heart.

[0025] In some embodiments of the disclosed device, the cover comprises multiple leaflets, each leaflet being arranged concentrically around a central axis.

[0026] In some embodiments of the disclosed device, the plurality of leaflets includes two or more leaflets, the two or more leaflets including a first leaflet and a second leaflet that at least partially overlap.

[0027] In some embodiments of the disclosed device, the first and second lobules are opened to define a gap for hemodynamic flow during cardiac diastole.

[0028] In some embodiments of the disclosed device, the first lobule and the second lobule are located proximal and distal to the central axis, respectively, and the atrium-facing surface of the first lobule at least partially overlaps the ventricle-facing surface of the second lobule.

[0029] In some embodiments of the disclosed apparatus, the plurality of leaflets includes two or more leaflets, and the two or more leaflets include two adjacent leaflets that at least partially overlap.

[0030] In some embodiments of the disclosed device, two adjacent leaflets open to define a gap for hemodynamic flow during cardiac diastole.

[0031] In some embodiments of the disclosed device, two adjacent lobular layers include a first lobular layer and a second lobular layer located proximal and distal to the central axis, respectively, with the atrium-facing surface of the first lobular layer at least partially overlapping the ventricle-facing surface of the second lobular layer.

[0032] In some embodiments of the disclosed device, the covering expands at least partially toward the natural valve leaflets during cardiac contraction.

[0033] In some embodiments of the disclosed device, the covering at least partially blocks the reflux port during cardiac contraction.

[0034] In some embodiments of the disclosed device, the anchoring mechanism includes one or more anchoring arms, each anchoring arm including a proximal end region connected at a central axis and a distal end region extending from the central axis, the distal end region of the anchoring arm being configured to be located at the commissure of the natural valve leaflets.

[0035] In some embodiments of the disclosed device, the distal end region is configured to engage with the annulus of the valve at the junction.

[0036] In some embodiments of the disclosed device, each of one or more anchoring arms is configured to have a range of shape expansions and to be adapted to the geometry of the annulus of the valve at the junction.

[0037] In some embodiments of the disclosed device, the anchoring arm is configured to rotate about the central axis of the anchoring mechanism.

[0038] In some embodiments of the disclosed device, one or more anchoring arms rotate about a central axis to match the angular distribution of the joint.

[0039] In some embodiments of the disclosed device, one or more anchoring arms include a first anchoring arm whose proximal end region includes a cylindrical protrusion aligned with a central axis.

[0040] In some embodiments of the disclosed device, one or more anchoring arms include a second anchoring arm whose proximal end region is fixedly connected to an inner core enclosed in a cylindrical protrusion, and the inner core is configured to rotate about a central axis relative to the first cylindrical protrusion.

[0041] In some embodiments of the disclosed device, rotating the inner core relative to the first cylindrical protrusion changes the angle between the first anchoring arm and the second anchoring arm.

[0042] In some embodiments of the disclosed device, one or more anchoring arms include a third anchoring arm whose proximal end region includes a central portion located between the cylindrical protrusion and the inner core, and is configured to rotate about a central axis relative to the inner core.

[0043] In some embodiments of the disclosed device, rotating the proximal end region of the third anchoring arm relative to the inner core alters the angle between the second and third anchoring arms.

[0044] In some embodiments of the disclosed device, the anchoring mechanism includes a locking ring configured to secure the relative position between one or more anchoring arms.

[0045] In some embodiments of the disclosed device, the anchoring arm is configured to rotate before being loaded into the catheter, after being deployed in the heart via the catheter, or a combination thereof.

[0046] In some embodiments of the disclosed device, one or more anchoring arms include three anchoring arms, each of which has a distal end region configured to be located at the respective juncture of the natural valve leaflet.

[0047] In some embodiments of the disclosed device, each of one or more anchoring arms includes an intermediate region between a proximal end region and a distal end region, the intermediate region being configured to be positioned against the inner supra-annular wall of the atrium.

[0048] In some embodiments of the disclosed device, the anchoring mechanism includes a height adjustment mechanism configured to individually control the shape of each of one or more anchoring arms.

[0049] In some embodiments of the disclosed device, the height adjustment mechanism includes a cable having a proximal end region slidably connected to a proximal end region of a first anchor arm among one or more anchor arms, the proximal end region of the first anchor arm being aligned with a central axis, and the cable having a distal end region connected to a distal extension of a selected anchor arm among one or more anchor arms.

[0050] In some embodiments of the disclosed device, the device also includes a shaft connecting the flow optimizer and the anchoring mechanism.

[0051] In some embodiments of the disclosed device, the shaft is threaded, such that rotation of the shaft relative to the anchoring mechanism changes the distance between the flow optimizer and the anchoring mechanism.

[0052] In some embodiments of the disclosed device, the shaft is threaded, such that rotation of the shaft relative to the anchoring mechanism alters the radial orientation of the flow optimizer relative to the anchoring mechanism.

[0053] In some embodiments of the disclosed device, the anchoring mechanism includes a locking ring configured to fix the relative position between the flow optimizer and the anchoring mechanism.

[0054] In some embodiments of the disclosed device, the shaft is configured to rotate relative to the anchoring mechanism before being loaded into the catheter, to rotate relative to the anchoring mechanism after being deployed in the heart via the catheter, or a combination thereof.

[0055] In some embodiments of the disclosed device, each of the flow optimizer and the anchoring mechanism has a crimped conformation suitable for being loaded in a catheter and a unfolded conformation suitable for unfolding in the heart.

[0056] In some embodiments of the disclosed device, the anchoring mechanism includes an anchoring device coupled to the flow optimizer and configured to anchor to the vena cava.

[0057] In some embodiments of the disclosed apparatus, the flow optimizer includes an atrial anchor coupled to the flow optimizer and configured to be anchored to the atrial wall.

[0058] In some embodiments of the disclosed apparatus, the flow optimizer includes a ventricular anchor coupled to the flow optimizer and configured to be anchored to the ventricular wall.

[0059] According to another aspect disclosed herein, a device for implantation is described, comprising:

[0060] An anchoring mechanism comprising one or more anchoring arms, each arm including a proximal end region connected at a central axis and a distal end region extending from the central axis, the distal end regions being configured to be located at the junction of the natural leaflets of the heart valve; and

[0061] An implant that is connected to and anchored to the valve via an anchoring mechanism.

[0062] In some embodiments of the disclosed device, the distal end region is configured to engage with the annulus of the valve at the junction.

[0063] According to another aspect disclosed herein, a method for deploying a device for supporting the function of a heart valve is described, comprising:

[0064] The distal end region of the catheter is delivered to the valve, where the device is loaded.

[0065] The flow optimizer of the device in the valve is expanded by partially retracting the catheter proximally; and

[0066] The device’s anchoring mechanism is opened by retracting the catheter at least partially proximally. This anchoring mechanism is coupled to the flow optimizer and configured to fix the position of the flow optimizer relative to the valve.

[0067] In some embodiments of the disclosed method, the anchoring mechanism includes one or more anchoring arms, each anchoring arm including a proximal end region connected at a central axis and a distal end region extending from the central axis, wherein opening includes partially opening one or more anchoring arms.

[0068] In some embodiments of the disclosed method, after partially opening one or more anchor arms, the method further includes aligning one or more anchor arms with the fusion of the natural leaflets of the valve. Attached Figure Description

[0069] Figure 1A This is a schematic diagram of an exemplary embodiment of a vena cava anchoring device in an unfolded configuration.

[0070] Figure 1B This is an exploded view of an exemplary embodiment of a vena cava anchoring device in an expanded configuration.

[0071] Figure 2A This is a schematic diagram of an exemplary embodiment of a vena cava anchoring device in a bundled configuration.

[0072] Figure 2B This is an exploded view of an exemplary embodiment of a vena cava anchoring device in a bundled configuration.

[0073] Figure 3A This is a schematic diagram of the distal end of an exemplary embodiment of a vena cava anchoring device in an unfolded configuration.

[0074] Figure 3B This is a schematic diagram of the height adjustment mechanism of the atrial arm in an exemplary embodiment of a vena cava anchoring device.

[0075] Figure 3C This is a detailed cross-sectional view of the height adjustment mechanism of the atrial arm in an exemplary embodiment of a vena cava anchoring device.

[0076] Figure 4 This is an isometric view of an exemplary embodiment of a tricuspid flow optimizer framework that can be used with the apparatus described herein.

[0077] Figure 5A This is a schematic diagram illustrating the configuration of an exemplary embodiment of a tricuspid valve flow optimizer having a single leaflet during the diastolic phase of the cardiac cycle.

[0078] Figure 5B This is a schematic diagram illustrating the configuration of an exemplary embodiment of a tricuspid valve flow optimizer with a single leaflet during the systolic phase of the cardiac cycle.

[0079] Figure 5C yes Figure 5B The diagram shows a cross-sectional view of the flow optimizer, illustrating the cross-section of the frame and leaflet layers.

[0080] Figure 6A and Figure 6C This is a schematic diagram illustrating the configuration of an exemplary embodiment of a tricuspid valve flow optimizer having overlapping (two) leaflet structures during the systolic phase of the cardiac cycle.

[0081] Figure 6B yes Figure 6A The cross-sectional view of the flow optimizer shown in the figure illustrates the frame and leaflet layer sections to further illustrate the principle and structure of the element.

[0082] Figure 6D yes Figures 6A-6C The diagram shows a view of the overlapping (two) leaflets of the flow optimizer.

[0083] Figure 6E This is a view of an exemplary embodiment of a sub-component of a single-layer leaflet molded in a relaxed configuration.

[0084] Figure 6F This is an exploded view of an exemplary embodiment of a flow optimizer 140, which is assembled with a frame 145 and sub-components of single-layer leaflets molded in a relaxed configuration.

[0085] Figure 7A and Figure 7C This is a schematic diagram illustrating the configuration of an exemplary embodiment of a tricuspid valve flow optimizer with overlapping leaflet structures during the diastolic phase of the cardiac cycle.

[0086] Figure 7B yes Figure 7A The diagram shows a cross-sectional view of the flow optimizer, illustrating the cross-section of the frame and leaflet layers.

[0087] Figure 7D yes Figures 7A-7C The diagram shows a view of the overlapping leaves of the flow optimizer.

[0088] Figure 7E This is a view of an exemplary embodiment of a sub-component of a single-layer leaflet molded in a contracted configuration.

[0089] Figure 8A This is a top view schematic diagram of one embodiment of a tricuspid flow optimizer described herein, which has two overlapping semi-rigid flaps in a relaxation configuration.

[0090] Figure 8B This is a top view schematic diagram of one embodiment of a tricuspid flow optimizer described herein, which has two overlapping semi-rigid blades in a contraction configuration.

[0091] Figure 8C This is an isometric schematic diagram of one embodiment of a tricuspid flow optimizer described herein, which has two overlapping semi-rigid blades in a relaxed configuration.

[0092] Figure 8D This is an isometric schematic diagram of one embodiment of a tricuspid flow optimizer described herein, which has two overlapping semi-rigid blades in a contraction configuration.

[0093] Figures 9A-9E The illustration shows the unfolding sequence of an exemplary embodiment of the vena cava anchoring device.

[0094] Figure 10 This is a wireframe diagram of an exemplary embodiment of a vena cava anchoring device that unfolds entirely within the heart.

[0095] Figure 11A This is a schematic diagram of an exemplary embodiment of an atrial and / or ventricular anchoring device in an unfolded configuration.

[0096] Figure 11B This is an exploded view of an exemplary embodiment of an atrial and / or ventricular anchoring device in an unfolded configuration.

[0097] Figure 12A This is a schematic diagram of an exemplary embodiment of an atrial and / or ventricular anchoring device in a bundle configuration.

[0098] Figure 12B This is an exploded view of an exemplary embodiment of an atrial and / or ventricular anchoring device in a bundle configuration.

[0099] Figure 13A This is a wireframe diagram of an exemplary embodiment of an atrial and ventricular anchoring device that unfolds entirely within the heart.

[0100] Figure 13BThis is a wireframe diagram illustrating an unfolded ventricular anchor of an exemplary embodiment of an atrial and / or ventricular anchoring device positioned at the apex of the ventricle.

[0101] Figure 14 This is a schematic diagram illustrating an exemplary embodiment of an unfolded atrial and / or ventricular anchoring device as viewed from the top of the right atrium.

[0102] Figure 15A and Figure 15B This is a schematic diagram of an exemplary embodiment of a height adjustment mechanism suitable for use with a ventricular anchoring device.

[0103] Figure 16A and Figure 16B This is a cross-sectional view of an exemplary embodiment of a height adjustment mechanism suitable for use with a ventricular anchoring device.

[0104] Figure 17A and Figure 17B This is a schematic diagram of an exemplary embodiment of an interlocking link that can be used with the hinged link in the device described herein.

[0105] Figure 18A This is a schematic diagram of an exemplary embodiment of an atrial anchoring device in an unfolded configuration.

[0106] Figure 18B This is a schematic diagram of an exemplary embodiment of an atrial anchoring device in a bundle configuration.

[0107] Figure 18C This is a schematic diagram illustrating an exemplary embodiment of an atrial anchoring device with a vertical height adjustment mechanism.

[0108] Figure 19A This is a schematic diagram of an atrial anchor component illustrating an exemplary embodiment of an atrial anchoring device with a height adjustment mechanism.

[0109] Figure 19B This is a schematic diagram illustrating an exemplary embodiment of a tricuspid valve flow optimizer component of an atrial anchoring device having a receiver portion for height adjustment mechanism.

[0110] Figure 19C This is a schematic cross-sectional view of an exemplary embodiment of a flow optimizer and an atrial anchor in a mating configuration via a height adjustment mechanism of an atrial anchoring device 300.

[0111] Figure 20 This is a wireframe diagram showing an exploded view of an exemplary embodiment of an atrial anchoring device in an unfolded configuration.

[0112] Figure 21AThis is a wireframe schematic diagram illustrating an exemplary embodiment of an atrial anchoring device deployed within the tricuspid valve anatomy.

[0113] Figure 21B This is a wireframe schematic diagram illustrating an exemplary embodiment of an atrial anchoring device deployed within the tricuspid valve anatomy as viewed from the right atrium.

[0114] Figure 22A This is a schematic diagram of an exemplary embodiment of a connecting anchoring device in an unfolded configuration.

[0115] Figure 22B This is a schematic diagram illustrating an exemplary embodiment of the combined anchoring device in an unfolded configuration, wherein arm 415a is not shown to allow visibility of the internal components of the anchoring mechanism 410.

[0116] Figure 22C This is a schematic diagram illustrating an exemplary embodiment of the combined anchoring device in an unfolded configuration, wherein arms 415a and 415b are not shown to allow visibility of the internal components of the anchoring mechanism 410.

[0117] Figure 22D This is a schematic diagram illustrating an exemplary embodiment of a combined anchoring device in an unfolded configuration, wherein arms 415a and 415b are not shown to allow visibility of the internal components of the anchoring mechanism 410.

[0118] Figure 23A This is a schematic diagram illustrating an exemplary embodiment of the connecting anchoring device in an unfolded configuration along a longitudinal cross-section of arm 415a.

[0119] Figure 23B This illustration shows an exemplary embodiment of the connecting anchoring device in an unfolded configuration, perpendicular to... Figure 23A The diagram shows a schematic of the longitudinal cross-section of the longitudinal cross-section.

[0120] Figure 24A This is a schematic diagram of an exemplary embodiment of a combined anchoring device in an unfolded configuration, wherein the anchoring mechanism 410 is separated from the flow optimizer 440.

[0121] Figure 24B This is an exploded view of an exemplary embodiment of the combined anchoring device in an unfolded configuration.

[0122] Figure 25 This is a schematic diagram of an exemplary embodiment of a connecting anchoring device in a bundled configuration.

[0123] Figure 26 This is a schematic atrial view of an exemplary embodiment of a commissural anchoring device in an unfolded configuration within the cardiac anatomy.

[0124] Figure 27 This is a schematic atrial view of an exemplary embodiment of a commissure anchoring device in an unfolded configuration within the cardiac anatomy, showing the placement of the anchoring arm within the tricuspid commissure.

[0125] Figure 28 This is a schematic ventricular view of an exemplary embodiment of a commissural anchoring device in an unfolded configuration within the cardiac anatomy, showing the placement of the anchoring arm within the commissure of the tricuspid leaflets.

[0126] Figure 29A and Figure 29B This is a schematic view of the anchoring arm of an exemplary embodiment of a combined anchoring device, shown in different expanded configurations.

[0127] Figures 30A-30C This is a schematic diagram of an exemplary embodiment of the anchoring device, illustrating the radial displacement function of the anchoring arm 415b. Arm 415a is not in... Figure 30B and Figure 30C The display allows visibility of the internal components of the anchoring mechanism 410.

[0128] Figures 31A-31C This is a schematic diagram of an exemplary embodiment of the connecting anchoring device, illustrating the radial displacement function of the anchoring arm 415c. Arm 415a is not in... Figure 31B and Figure 31C The display allows visibility of the internal components of the anchoring mechanism 410.

[0129] Figure 32A This is an atrial (top view) of an exemplary embodiment of the combined anchoring device, wherein the anchoring arm 415 is radially positioned in a symmetrical configuration.

[0130] Figure 32B This is an atrial (top view) of an exemplary embodiment of the combined anchoring device, wherein the anchoring arm 415c extends from... Figure 32A The position shown begins to move radially clockwise toward arm 415a.

[0131] Figure 32C This is an atrial (top view) of an exemplary embodiment of the combined anchoring device, wherein the anchoring arm 415c extends from... Figure 32B The position shown begins to move radially counterclockwise toward arm 415b.

[0132] Figure 32D This is an atrial (top view) of an exemplary embodiment of the combined anchoring device, wherein the anchoring arm 415b extends from... Figure 32C The position shown begins to move radially counterclockwise toward arm 415a.

[0133] Figure 32E This is an atrial (top view) of an exemplary embodiment of the combined anchoring device, wherein the anchoring arm 415c extends from... Figure 32D The position shown begins to move radially counterclockwise toward arm 415b.

[0134] Figure 33A and Figure 33B This is a schematic diagram illustrating the height and radial orientation adjustment functions of an exemplary implementation of a flow optimizer.

[0135] Figure 34A This is a close-up view of an exemplary embodiment of the coupling anchoring device with the locking ring 420 disengaged.

[0136] Figure 34B This is a longitudinal cross-sectional view of an exemplary embodiment of the coupling anchoring device with the locking ring 420 disengaged.

[0137] Figure 34C This is a close-up view of an exemplary embodiment of the coupling anchoring device 400 with the locking ring 420 engaged.

[0138] Figure 34D This is a longitudinal cross-sectional view of the connecting anchoring device 400 with the locking ring 420 engaged.

[0139] Figure 35 This is a schematic diagram illustrating an exemplary embodiment of a combined anchoring device in an extended configuration, wherein the anchoring mechanism 410 includes components that independently control the expansion and / or retraction of each arm.

[0140] Figure 36 This is an atrial view illustrating an exemplary embodiment of the syn-anchoring device in an expanded configuration, wherein the anchoring mechanism 410 includes components that independently control the expansion and / or retraction of each arm.

[0141] Figure 37 The illustration shows a longitudinal cross-section of an exemplary embodiment of a combined anchoring device in an unfolded configuration, wherein the anchoring mechanism 410 includes components that independently control the expansion and / or retraction of each arm.

[0142] Figure 38 yes Figure 35 A schematic diagram of the combined anchoring device, wherein arm 415a is not shown to allow visibility of the internal components of the anchoring mechanism.

[0143] Figure 39A and Figure 39B It shows Figure 35 A schematic diagram of the connecting anchoring device, in which arm 415b is in different expansion configurations.

[0144] Figure 40A This is a schematic diagram of an exemplary embodiment of a delivery system conduit for connecting and anchoring devices.

[0145] Figure 40B yes Figure 40A The diagram shows a delivery system conduit, with the outer layer 451 removed to show the coupling anchoring device in the loading configuration.

[0146] Figure 41A This is a schematic diagram of an exemplary embodiment of a delivery system conduit, wherein the outer layer 451 is retracted and the anchoring device is in an deployed configuration.

[0147] Figure 41B This is a schematic diagram of an exemplary embodiment of a delivery system conduit, wherein the outer layer 451 is removed and the coupling anchoring device is in an deployed configuration.

[0148] Figure 42A This is a close-up view of an exemplary embodiment of the connection mechanism between the distal end of the delivery conduit and the proximal end of the connecting anchoring device.

[0149] Figure 42B yes Figure 42A A close-up view of the schematic diagram shows the simultaneous rotation of the arm 415c of the connecting anchoring device and the intermediate cavity 452 of the delivery system conduit.

[0150] Figure 43A This is a close-up view of the connection between the slider 455 of the delivery system conduit and the inner core 418 of the connecting anchoring device.

[0151] Figure 43B yes Figure 43A A close-up view of the schematic diagram shows the simultaneous rotation of the inner core 418 of the connecting anchoring device and the inner cavity 454 of the delivery system conduit.

[0152] Figure 44 This is a close-up view of the connection mechanism between the distal end of the delivery conduit and the proximal end of the connecting anchoring device, showing the slider 453 being pushed distally to activate the locking ring 420.

[0153] Figure 45A This is a close-up view of the connection mechanism between the distal end of the delivery conduit and the proximal end of the connecting anchoring device, showing sliders 453 and 455, which are disconnected from the arm 415c and the inner core 418, respectively.

[0154] Figure 45B This is a close-up view of the connection mechanism between the distal end of the delivery conduit and the proximal end of the connecting anchoring device, showing sliders 453, 455 and 454, which are disconnected from the arm 415c, the inner core 418 and the threaded shaft 419, respectively.

[0155] It should be noted that the accompanying drawings are not drawn to scale, and for illustrative purposes, elements with similar structures or functions are generally represented by similar reference numerals throughout the drawings. It should also be noted that the drawings are intended merely to facilitate the description of preferred embodiments. The drawings do not illustrate every aspect of the described embodiments and do not limit the scope of this disclosure. Detailed description

[0156] The disclosed implementation scheme relates to a catheter-delivered intracardiac implant for supporting and improving tricuspid valve function.

[0157] This disclosure captures a novel device with one or more features to address such anatomically and hemodynamically challenging scenarios. During diastole of the cardiac cycle, the flow optimizer is designed to minimize its cross-sectional area and allow hemodynamic flow around and through the implant, thus minimizing the potential risk of inducing atrioventricular pressure gradients and thrombosis. During systole, the flow optimizer seals or minimizes the reflux orifice and restores tricuspid valve efficacy. The device's anchoring system does not require invasive interaction with the tricuspid valve, right atrium, and right ventricle, and implantation can be achieved with minimal procedural steps. Furthermore, the device's anchoring mechanism allows for in-program adjustment of the flow optimizer's positioning within the native tricuspid valve under standard imaging techniques (e.g., fluoroscopy, echocardiography) to allow for real-time optimization of hemodynamic flow through the tricuspid valve. This disclosure is designed to improve the efficacy, safety, and procedural success of transcatheter tricuspid regurgitation.

[0158] This disclosure provides a tricuspid valve support device capable of reducing or preventing tricuspid regurgitation (TR). The device can be configured in a bundled configuration, allowing deployment using a standard intravascular catheter, and can also be configured for in vivo deployment. Typically, the device has a tricuspid flow optimizer placed within the tricuspid valve cavity. The flow optimizer allows hemodynamic flow from the right atrium to the right ventricle during diastole and, during cardiac systole, reduces or prevents blood from flowing back from the right ventricle to the right atrium through a regurgitation port present in the tricuspid valve of a subject affected by TR. The flow optimizer is directly connected to an anchoring structure that engages the tricuspid valve annulus at the junction of the natural leaflet and / or the superior wall of the right atrium. In alternative configurations, the flow optimizer is attached directly or via a hinged link to the anchoring element. The hinged link can be configured to adopt and maintain a three-dimensional configuration to retain proper shape and orientation from the anchoring device and within the tricuspid valve cavity. The anchoring element may be an intravascular stent configured to anchor the device via frictional contact within the SVC or IVC, thereby providing support to the flow optimizer from the atrial side, and may also include an atrial support or anchoring structure. Alternatively, the anchoring element frictionally engages with the inner wall of the right ventricle, preferably at the ventricular apex. Optionally, the latter configuration may also include an atrial anchoring structure.

[0159] Although the tricuspid valve is shown and described with reference to it for illustrative purposes only, the device, flow optimizer and / or anchoring mechanism can be applied to any valve of the heart.

[0160] In some embodiments, the device may be at least partially oriented such that two opposing end regions of the device are respectively close to and far from the heart. In these embodiments, "distal" can be a relative term, referring to a direction or side toward the heart, and more specifically, a direction or side toward the apex of the heart's ventricles. For example, Figure 1A The flow optimizer 140 is located at the distal end of the vena cava anchoring device, as described in more detail below. In those embodiments, "proximal" can be a relative term, referring to a direction away from the heart or to one side. For example, Figure 1A The anchoring stent 110 is located at the proximal end of the vena cava anchoring device, as described in more detail below.

[0161] This disclosure provides an implantable tricuspid valve support device that can be delivered and implanted using a catheter. The device provides a flow optimizer placed within the tricuspid valve to support and improve hemodynamic function in patients affected by tricuspid regurgitation (TR). The device seals the junctional gap between the natural leaflets during the systolic phase of the cardiac cycle and allows blood flow from the right atrium to the right ventricle during the diastolic phase of the cardiac cycle. In some embodiments, this disclosure provides an anchoring device. Anchoring can be achieved from the atrial side, such as within the superior vena cava (SVC) or inferior vena cava (IVC), or anchoring can be achieved from within the right ventricle by supporting the device. In some embodiments, the device is anchored only within the right atrium. In other embodiments, the device is anchored within the right atrium, at the junction of the tricuspid annulus, and / or in the annular region of the right atrium.

[0162] Vein-anchored tricuspid valve support device—100

[0163] Figure 1A The illustration shows a tricuspid valve support device 100 in an deployed configuration, which is configured to be anchored in the vena cava. The vena cava may include the superior vena cava (SVC) and / or the inferior vena cava (IVC). Figure 1A The device 100 is shown as including an anchoring bracket 110 connected to an atrial anchor 130 via a hinged link 120. The atrial anchor 130 is attached to a tricuspid valve flow optimizer 140 and includes one or more (e.g., one, two, three, four or more) atrial support arms 135. Figure 1B The illustration shows an exploded view of these elements in an unfolded configuration. Figure 2A The illustration shows the tricuspid valve support device 100 in a bundle configuration when it can be loaded into an intravascular delivery catheter (not shown). Figure 2B An exploded view of the tricuspid valve support device 100 in a bundled configuration is shown. Each of the device elements and the method of deployment will be described in more detail below.

[0164] Anchoring bracket 110

[0165] The anchoring stent 110 is sized and adapted for both bundled configurations (when loaded and housed within an intravascular catheter) and deployed configurations. The anchoring stent 110 can be self-expanding and / or balloon-deployable. The anchoring stent 110 can be appropriately sized for the desired anchoring vessel (i.e., SVC or IVC) and configured and constructed according to standard techniques and materials used for intravascular stents. For example, the anchoring stent 110 can be made of stainless steel, shape-memory metals, etc. Formed from NiTi or any suitable biocompatible polymer. The anchoring stent 110 is used to anchor the device in the body through frictional contact with the inner wall of the blood vessel while maintaining patency. The anchoring stent 110 may have a generally cylindrical stent body 112. The stent body 112 may be attached to a hinged link 120 at its distal end region. In one configuration, the stent body 112 may be attached to the proximal end region of the hinged link 120 at its distal end region via one or more (e.g., one, two, three, four or more) stent arms 111.

[0166] Hinged Link 120

[0167] The articulated link 120 is adapted to connect the anchoring support 110 to the atrial anchor 130 without significantly obstructing blood flow. For example, the articulated link 120 may be configured to remain toward the center and / or midline of the vessel when deployed. The articulated link 120 may be solid or hollow. The articulated link 120 also includes a receiver 121 at its distal end, which is adapted to receive and secure the atrial anchor 130. The receiver 121 may include a first mating pair member adapted to mate with a second mating pair member located on the atrial anchor 130. The receiver 121 may be articulated or non-articulated. In embodiments where the receiver 121 is non-articulated, it is configured to remain completely within the atrium, such that the lack of articulation does not interfere with the proper placement and orientation of the atrial anchor 130 and / or the flow optimizer 140.

[0168] The articulated link 120 is configured to accommodate and retain any three-dimensional curvature deformation induced by the catheter delivery system. Various gooseneck tubes, interlocking coils, and interlocking links can be used based on the principles described herein. Figure 17A and Figure 17B The illustration shows two exemplary types of interlocking links that can be used.

[0169] Atrial anchor 130

[0170] The atrial anchor 130 includes a second mating pair member adapted to mate with a first mating pair member located on the receiver 121. The atrial anchor 130 may include one or more (e.g., one, two, three, four, or more) radially extended atrial support arms 135. The atrial anchor 130 is adapted to support the flow optimizer 140 at its distal end region and within the tricuspid valve (e.g., via the receiver 121). Preferably, the arms 135 extend from a bound configuration to an extended configuration upon release from the delivery catheter. The arms 135 may be formed of any suitable material, including shape-memory materials such as NiTi. Optionally, the arms 135 may also include a friction-enhancing layer on the body-facing surface of the arms 135 to enhance adhesion to the atrial wall. Exemplary friction-enhancing layers may be made of polymers, including, for example, fabric hook-and-loop fasteners (e.g., available from Velcro Ltd., UK). ) and micro barbs.

[0171] Additionally and / or alternatively, the atrial anchor 130 also includes a height adjustment mechanism adapted to vertically position the adjustment arm 135 relative to the flow optimizer 140. Figure 3A An exemplary height adjustment mechanism defining a channel 131 is illustrated. The channel 131 has a series of notches 132, in which an arm 135 is mounted. Figure 3B It provides a close-up view of the vertical positioning system, and Figure 3C A cross-sectional view of the internal components is provided. The distal end region of each arm 135 terminates in an earpiece 136. Each arm 135 is slidably engaged with a channel 131 in the receiver 121, such that the arm 135 can be displaced in a proximal or distal axial direction. The channel 131 defines a series of horizontal notches 132, the notches 132 being sized to receive the earpiece 136.

[0172] In one embodiment, the arm 135 can be positioned in an deployed configuration before the device 100 is loaded into the delivery catheter. The choice of height positioning can be determined using imaging and / or other data obtained from the patient.

[0173] Additionally and / or alternatively, after the device 100 has deployed within the atrium, the arm 135 may be positioned proximally or distally relative to the flow optimizer 140. For example, the arm 135 may be displaced relative to the flow optimizer 140 using an internal operator-controlled line fixed to the distal end of the arm 135 and adapted to pull the distal end region of the arm 135 inward toward the central axis of the cavity of the device 100, thereby releasing the ear flap 136 from the notch 132. The arm 135 may be displaced in the axial direction, and when tension from the catheter is released, the spring / memory shape properties of the distal end return the ear flap 136 to the notch 132.

[0174] Additionally and / or alternatively, the earpiece 136 is reversibly engaged with a wire or tube inside the catheter lumen in a manner that keeps the earpiece 136 detached from the notch 132. After the device is deployed, the operator can use the internal wire or tube to displace the arm 135 until the arm 135 is properly positioned within the atrium (e.g., frictionally engaged with the atrial wall), and they disengage the earpiece 136 from the internal wire or tube, causing the earpiece 136 to engage with the notch 132.

[0175] Tricuspid Flow Optimizer 140

[0176] Figure 4 The tricuspid valve flow optimizer 140 is shown as a conical shape. However, the tricuspid valve flow optimizer 140 can be formed into any desired shape, preferably matching the tricuspid valve anatomy to ensure non-invasive engagement of the natural tricuspid leaflets on the flow optimizer during cardiac systole. Specifically, during the systolic phase of the cardiac cycle, the flow optimizer 140 is designed to engage with the tricuspid leaflets and fill the reflux orifice in the tricuspid valve. During the diastolic phase of the cardiac cycle, the flow optimizer 140 allows hemodynamic flow from the right atrium to the right ventricle. The exemplary flow optimizer 140 may include a frame 145. The exemplary frame 145 may be formed of a shape-memory material. For example, the frame 145 may include a wire / band frame made of a shape-memory material such as NiTi. The exemplary flow optimizer 140 may include a covering formed of one or more (e.g., two, three, four, five or more) layers of leaflets 150 (such as...). Figure 5A (As shown in the image).

[0177] like Figure 4As shown, the flow optimizer frame may include two or more (e.g., two, three, four, five or more) arms 146 that support the covering material and impart the desired three-dimensional shape to the leaflets 150. The leaflets 150 may be made of a material impermeable to blood cells, and preferably a material impermeable to blood fluids (e.g., aqueous solutions). The leaflets 150 may be formed of any suitable biocompatible material, including, for example, woven or nonwoven polymer fabrics or sheets, and / or biological tissue obtained from animals (e.g., cattle, pigs, and horses) or humans. Suitable biological tissues include, for example, tissue obtained from the pericardial sac of a donor animal and / or human. The leaflets 150 are sewn or attached to the arms 146 of the frame 145 using other standard fastening methods (e.g., adhesives). Additionally and / or alternatively, the leaflets 150 may be molded as a single sub-component that can be mounted on the frame 145 in a desired three-dimensional shape, such as... Figures 6E-6F and Figure 7E As shown in the figure.

[0178] like Figure 5A As shown, the tricuspid valve flow optimizer 140 can be configured to allow leaflets 150 to collapse toward the central axis of frame 145 during cardiac diastole (or the diastolic phase of the cardiac cycle). The leaflets 150 of the tricuspid valve flow optimizer 140 are made of a flexible but impermeable material that forms a foldable dome and / or other three-dimensional structure. During cardiac diastole, as 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 (not shown). The atrioventricular hemodynamic pressure gradient causes the leaflets 150 of the flow optimizer 140 to collapse toward the central axis of frame 145, such that the three-dimensional volume and cross-sectional area of ​​the flow optimizer 140 can be... Figure 5A The reduced flow area allows blood to flow unrestricted into the ventricle around the optimizer 140. When viewed from the right atrium, the cross-sectional area of ​​the tricuspid flow optimizer 140 may include the dimensions of the tricuspid flow optimizer 140.

[0179] like Figure 5B As shown, the tricuspid valve flow optimizer 140 can be configured to expand toward arm 146 to fill the lumen of the reflux orifice (not shown) and thereby prevent reflux during cardiac contraction. Figure 5B As shown, during cardiac contraction (i.e. ventricular contraction), when the tricuspid valve leaflets engage around the flow optimizer 140, ventricular hemodynamic pressure will cause the leaflets 150 to expand to their full three-dimensional volume, which is sufficient to close the tricuspid valve orifice and reduce or prevent blood flow into the right atrium.

[0180] Additional and / or alternative, such as Figure 6A As shown, the covering of the flow optimizer 140 can be formed by the overlapping cascade of two or more (e.g., two, three, four or more) circumferential lobular layers of the leaflets 150 to achieve an effective reduction in three-dimensional volume during diastole and to leave open gaps between the lobular layers of the leaflets 150, allowing blood flow paths through the flow optimizer 140. These gaps further minimize the cross-sectional area of ​​the flow optimizer 140, which can restrict hemodynamic flow and thus reduce the likelihood of pressure gradients forming on the natural tricuspid valve. These gaps also improve blood flushing within the flow optimizer, minimizing blood stagnation and thus minimizing the risk of thrombosis. The circumferential lobules are aligned such that the distal (bottom or ventricular side) edge of the upper lobular layer (closest to the atrium) 150a overlaps the interior of the proximal (upper or atrial side) edge of the lower lobular layer (closest to the ventricle) 150b.

[0181] like Figures 6A-6D As shown, during cardiac contraction, ventricular pressure causes the leaflets of the tricuspid valve to close, causing the leaflets to engage around the flow optimizer 140 and expanding the leaflet layers 150a, 150b into a fully three-dimensional shape, pressing the leaflet layers 150a, 150b together to create a gap 152 ( Figure 7A (as shown in the diagram) seals and prevents blood from passing through the flow optimizer 140 and flowing into the ventricle around the flow optimizer 140.

[0182] During diastole, depending on the material and shape of the structure and selection, the lobules 150a and 150b of the flow optimizer 140 partially and / or completely collapse, allowing blood to flow from the atria around the flow optimizer 140 and also through the lobules 150a and 150b (e.g., Figures 7A-7D The gap 152 between the lobules (as shown in the diagram) allows water to flow into the ventricle. A similar pattern of overlapping three, four, or more lobule layers can be used for each lobule 150.

[0183] exist Figure 8A and Figure 8C In one embodiment shown, six flaps 250a, 250b arranged on two layers allow hemodynamic flow through the gaps 254 of the flow optimizer 140 during the diastolic phase of the cardiac cycle. Figure 8B and Figure 8DAs shown, flaps 250a and 250b close gap 254 during the systolic phase of the cardiac cycle, thus preventing backflow through the natural tricuspid valve. Flaps 250a and 250b are semi-rigid to maintain their shape when open or closed. Three flaps 250a are arranged on the upper layer of frame 248, and three flaps 250b are arranged on the lower layer of frame. Flaps 250a and 250b are connected to frame 248 of flow optimizer 140 by connecting strips 252a and 252b, which are patches of soft tissue or other flexible, impermeable material to prevent blood from crossing the boundaries of flaps 250a and 250b. The patches are connected to frame 248 by hinges 251a and 251b. Figure 8A and Figure 8C The flow optimizer 140 is shown during the diastolic phase of the cardiac cycle, when the atrioventricular pressure gradient causes vanes 250a and 250b to rotate about hinges 251a and 251b in the direction of hemodynamic flow. In this configuration, blood can pass through an open gap 254 between vanes 250a and 250b, providing a washing effect to prevent blood stagnation and the risk of thrombosis within the flow optimizer.

[0184] Figure 8B The flow optimizer 140 is shown during the systolic phase of the cardiac cycle, when the atrioventricular pressure gradient causes the vanes 250a and 250b to rotate toward the atrium. In this configuration, the distal edge (closer to the ventricle) of vane 250b overlaps with the proximal edge (closer to the atrium) of vane 250a, thus sealing the gap 254 and preventing blood from passing through.

[0185] Deployment of the vena cava support device 100

[0186] Device 100 can be anchored in the SVC and / or IVC, depending on which vessel it enters. This paper illustrates deployment via the SVC. The same principles and techniques can be applied to deployment of device 100 via the IVC.

[0187] Figures 9A-9E The diagram illustrates the unfolding sequence of the device 100 within the heart 10 of an object (e.g., a patient). Figure 9A The illustration shows the device inserted into the right atrium 11 via SVC 12. The device 100 is housed within an intravascular delivery catheter (not shown), which holds the device 100 in a bundle configuration. Figure 9B As illustrated, device 100 is deflected toward tricuspid valve 13 using a catheter manipulation mechanism. When aligned with tricuspid valve 13, device 100 can be pushed in such that the distal end region of device 100 (and catheter) is located within right ventricle 14. Flow optimizer 140 can be as follows: Figure 9CThe device 100 is positioned such that the flow optimizer 140 is disposed within the tricuspid valve 13. The flow optimizer 140 can be deployed by retracting a portion of the duct. Figure 9D As shown, arm 135 can be deployed such that the distal end region of arm 135 is positioned on top of tricuspid valve 13 and / or against the wall of atrium 11, thereby suspending flow optimizer 140 within tricuspid valve 13. Optionally, arm 135 can be height-adjusted as described herein. Figure 9E A perspective view of the fully unfolded device 100 is provided. Figure 10 A wire drawing illustrating the device 100 fully deployed within the heart 10 is provided.

[0188] Atrial / ventricular anchored tricuspid valve support device—200

[0189] Figure 11A The illustration shows a tricuspid valve support device 200 in an expanded configuration, which is anchored in the right ventricle and right atrium. Figure 11A The device 200 is shown as including a ventricular anchor 210, which may include one or more (e.g., one, two, three, four or more) support arms 215 connected to a hinged link 220 attached to a tricuspid flow optimizer 240. Additionally and / or alternatively, the device 200 may also include an atrial anchor 230, which may have one or more (e.g., one, two, three, four or more) arms 235. Arms 235 may be radially disposed from the central axis of the device 200 and may be a single band or rod, or a regular or random geometry, as illustrated. Figure 11B An exploded view of the tricuspid valve support device 200 in its deployed configuration is shown. Figure 12A illustrates the tricuspid valve support device 200 in its bundled configuration when it can be loaded into an intravascular delivery catheter (not shown). Figure 12B An exploded view of the tricuspid valve support device 200 in a bundled configuration is shown. Each of the device elements of the tricuspid valve support device 200 and the method of deployment are described in more detail below.

[0190] Ventricular anchor 210

[0191] The ventricular anchor 210 is configured and adapted to support the device 200 by abutting against the inner wall of the right ventricle at and / or near the ventricular apex. In some embodiments, the ventricular anchor 210 includes a plurality of arms 215 on its distal side. The arms 215 may be formed of a shape-memory material as described herein, such that the arms 215 self-expand upon release from an intravascular delivery catheter. The arms 215 may be formed of any suitable material, including shape-memory materials such as NiTi. Additionally and / or alternatively, the arms 215 may include a friction-enhancing layer (e.g., a polymer), comprising, for example... And micro-barbs to enhance adhesion to the ventricular wall. Additionally and / or alternatively, arm 215 may partially penetrate the ventricular wall to facilitate anchoring. Ventricular anchor 210 is attached to hinge link 220 at the distal end region of hinge link 220.

[0192] Hinged Link 220

[0193] The articulated link 220 may have a similar or identical structure to the articulated link 120, as described above in the context of device 100. The tricuspid flow optimizer 240 may be attached to the proximal end region of the articulated link 220.

[0194] Tricuspid Flow Optimizer 240

[0195] Tricuspid flow optimizer 240 may have the same or similar structure as tricuspid flow optimizer 140, as described above in the context of device 100. Tricuspid flow optimizer 240 may be supported from the ventricle at the ventricular apex by a hinged link 220 and from the atrium by an atrial anchor 230.

[0196] Additionally and / or alternatively, the flow optimizer 240 and the articulated link 220 may have a height adjustment mechanism to allow for more precise positioning of the flow optimizer 240 within the tricuspid valve. In one embodiment, in Figures 15A-15B and Figures 16A-16BAs illustrated, the articulated link 220 may have a centrally located non-articulated attachment member 225 defining a plurality of notches 226. The flow optimizer 240 includes a frame 242 having a centrally located sleeve 244, one or more detents 246 configured to engage with the notches 226. Positioning of the flow optimizer 240 can be adjusted by sliding the frame 242 longitudinally along the attachment member 225 to disengage the detents 246 from and re-engage them with the notches 226. In one embodiment, the detents 246 are configured to allow sliding in only one direction. For example, a unidirectional detent 246 is configured to allow displacement in the proximal direction (i.e., toward the ventricular apex). In another embodiment, the frame 242 and the attachment member 225 have a threaded engagement allowing an operator to rotate the frame 242 to induce displacement in either direction.

[0197] Atrial anchor 230

[0198] Additionally and / or alternatively, the device 200 may include an atrial anchor 230 extending proximally from the tricuspid flow optimizer 240 into the right atrium. When deployed, the atrial anchor 230 rests on the inner wall of the right atrium above and / or adjacent to the annulus of the tricuspid valve to provide additional support and stability to the tricuspid flow optimizer 240. The atrial anchor 230 may include one or more (e.g., one, two, three, four, or more) support arms 235. Arms 235 may be linear and / or contoured to conform to the atrial wall in and / or adjacent to the annulus region of the tricuspid valve. Alternatively, each arm 235 may include a line defining a closed shape. Preferably, the atrial anchor 230 and / or arms 235 are formed of a shape-memory material (e.g., NiTi) such that they self-expand upon release from the delivery catheter. Additionally and / or alternatively, arm 235 may include a friction-enhancing layer (e.g., a polymer) on its body-facing surface, including, for example... And micro-barbs to enhance adhesion to the atrial wall.

[0199] In one embodiment, the atrial anchor 230 can be locked in a desired position relative to the articulated link 220 before the device 200 is loaded into the delivery catheter. The choice of height positioning can be determined using imaging and / or other data obtained from the patient.

[0200] Additionally and / or alternatively, after the ventricular anchor 210 has deployed within the ventricle, the atrial anchor 230 may be positioned proximally or distally relative to the articulated link 220. For example, the atrial anchor 230 may be displaced relative to the articulated link 220 via an internal operator-controlled cavity within a central sleeve 244 fixed to the flow optimizer 240. A second operator-controlled cavity, connected to the proximal end of the articulated link 220 and covering a notch 226, prevents the notch 226 from engaging with a stop 246 of the sleeve 244. Once the flow optimizer 240 has been displaced to the desired position on the articulated link 220, the second operator-controlled cavity can be retracted to expose the notch 226, thus allowing the stop 246 to engage with the notch 226 and lock the flow optimizer 240 in position on the articulated link 220.

[0201] Deployment of ventricular support device 200

[0202] Similar to the deployment of device 100, device 200 can be deployed and delivered via the SVC or IVC using an intravascular catheter (not shown). The catheter is pushed from the right atrium through the tricuspid valve into the right ventricle, with the catheter lumen positioned near the ventricular apex. The outer lumen of the catheter can be partially retracted to deploy the ventricular anchor 210 and / or arm 215. Using a catheter with a tamperable distal end, the positioning of device 200 can be adjusted to place the ventricular anchor 210 at the ventricular apex. The outer lumen of the catheter can be further retracted to expose the articulated link 220 and the flow optimizer 240. The articulated link 220 can be manipulated using the tamperable distal end of the catheter to place the flow optimizer 240 at the desired location within the tricuspid valve. The outer lumen of the catheter can be fully retracted to deploy the atrial anchor 230. Figure 13A This is a wireframe diagram showing the device 200 fully deployed in the right atrium. Figure 13B This is an enlarged illustration showing the location of the ventricular anchor 210 at the ventricular apex of the right ventricle. Figure 14 This is a diagram of the unfolded device 200 as viewed from the atrial side.

[0203] Right atrial anchored tricuspid valve support device—300

[0204] Figure 18A The illustration shows a tricuspid valve support device 300 in an expanded configuration, which is anchored in the right atrium. Figure 18A The device 300 is shown in position including an atrial anchor 310. The atrial anchor 310 may include one or more (e.g., one, two, three, four or more) support arms 315 attached to the tricuspid valve flow optimizer 340. The arms 315 may be radially disposed from the central axis of the device 300 and may be a single band or rod, or a regular geometry or random shape, as illustrated. Figure 18BThe illustration shows the tricuspid valve support device 300 in a bundled configuration when it can be loaded into an intravascular delivery catheter. Figure 18C The diagram illustrates a tricuspid valve support device 300, which includes an optional vertical height adjustment mechanism to change the relative distance between the flow optimizer 340 and the atrial anchor 310. Each of the device elements and the method of deployment will be described in more detail below.

[0205] Tricuspid Flow Optimizer 340

[0206] Tricuspid flow optimizer 340 may have the same or similar structure as tricuspid flow optimizer 140, as described above in the context of device 100. Tricuspid flow optimizer 340 may be supported proximally by atrial anchor 310.

[0207] Atrial anchor 310

[0208] The device 300 also includes an atrial anchor 310 that extends proximally from the tricuspid flow optimizer 340 into the right atrium. When deployed, the atrial anchor 310 rests on the inner wall of the right atrium above and / or adjacent to the annulus of the tricuspid valve to provide support and stability to the tricuspid flow optimizer 340. The atrial anchor 310 may include one or more (e.g., one, two, three, four or more) support arms 315. The arms 315 may be linear and / or conformal to the atrial wall in and / or adjacent to the annulus region of the tricuspid valve, and they may have individual shapes and / or lengths. Alternatively, the arms 315 may include lines defining a closed shape, such as an annular shape. Preferably, the atrial anchor 310 and / or arms 315 are formed of a shape-memory material (e.g., NiTi) such that the atrial anchor 310 and / or arms 315 self-expand upon release from the delivery catheter. Optionally, arm 315 also includes a friction-enhancing layer (e.g., a polymer) on the body-facing surface, including, for example... And micro-barbs to enhance adhesion to the atrial wall.

[0209] Optionally, the flow optimizer 340 and the atrial anchor 310 can be coupled to a height adjustment mechanism to allow for more precise positioning of the flow optimizer 340 within the tricuspid valve. In one embodiment, in Figures 19A-19C and Figure 20 As illustrated in the diagram, the atrial anchor 310 has a centrally located hinged or non-hinged attachment member 345 defining a plurality of notches 346. The flow optimizer 340 includes a frame 342 having a centrally located sleeve 344, one or more of which have stops 347 configured to mate with the notches 346. Figure 19CAs shown, the positioning of the flow optimizer 340 can be adjusted by sliding the frame 342 longitudinally along the attachment member 345 to disengage the stop 347 from and re-engage it with the notch 346. In one embodiment, the notch 346 is configured to allow sliding in both distal and proximal directions. Alternatively, the unidirectional notch 346 is configured to allow displacement in one direction, either distally (e.g., toward the ventricle) or proximally (e.g., toward the atrium). In another embodiment, the frame 342 and the attachment member 345 have a threaded engagement that allows an operator to rotate the frame 342 to allow displacement in either direction.

[0210] In one embodiment, the atrial anchor 310 can be positioned in a desired location relative to the flow optimizer 340 before the device 300 is loaded into the delivery catheter. The choice of height positioning can be determined using imaging and / or other data obtained from the patient.

[0211] Additionally and / or alternatively, after the device 300 is deployed within the atrium, the atrial anchor 310 may be positioned proximally or distally relative to the flow optimizer 340. For example, the atrial anchor 310 may be displaced relative to the flow optimizer 340 via an internal operator-controlled cavity fixed to the proximal end of the flow optimizer 340. A second operator-controlled cavity, connected to the distal end of the anchoring mechanism 310 and covering the notch 346, prevents the notch 346 from engaging with the stop 347. Once the desired positioning of the flow optimizer 340 on the anchoring mechanism 310 is achieved, the second operator-controlled cavity is retracted to expose the notch 346, thus allowing the stop 347 to engage the notch 346 and lock the position of the flow optimizer 340 on the anchoring mechanism 310.

[0212] Deployment of ventricular support device 300

[0213] Similar to the deployment of device 100, device 300 can be deployed and delivered via an intravascular catheter through the SVC or IVC. For example, the catheter is pushed from the right atrium through the tricuspid valve into the right ventricle, with the catheter lumen positioned near the ventricular apex. The catheter can be partially retracted, exposing the flow optimizer 340 and the atrial anchor 330. The catheter can be further retracted to deploy the shortest atrial anchor arm 315. The catheter can be fully retracted, deploying all remaining atrial arms 315. Figure 21A This is a wireframe diagram showing the device 300 fully deployed in the right atrium. Figure 21B This is a diagram of the unfolded device 300 as viewed from the atrial side.

[0214] Combined Anchored Tricuspid Valve Support Device—400

[0215] Figures 22A-22D and Figures 23A-23B The illustration shows a tricuspid valve support device 400 in an expanded configuration, configured to be anchored at the annulus of the tricuspid valve corresponding to the fusion of the natural leaflets. Typically, the device 400 includes an anchoring mechanism 410, which may comprise one or more (e.g., one, two, three, four, or more) support arms 415 connected via threaded shafts 419 to a tricuspid valve flow optimizer 440. Arms 415 may be radially disposed from the central axis of the device 400 and may be single bands or rods defining a geometry, regular shape, and / or random shape, as illustrated. Alternatively, arms 415 may be formed by lines defining a closed shape. The end regions (or distal end regions) 416 of arms 415a-415c are shaped to conform to the tissue wall of the tricuspid valve annulus at the fusion of the natural leaflets. The intermediate portion 417 of arms 415 is shaped to conform to the superior wall of the inner annulus of the right atrium to provide further support and / or stabilization. Figure 25 The illustration shows the tricuspid valve support device 400 in a bundled configuration when it can be loaded into an intravascular delivery catheter. Each of the device elements and the method of deployment will be described in more detail below.

[0216] Tricuspid Flow Optimizer 440

[0217] Tricuspid flow optimizer 440 may have a similar or identical structure to tricuspid flow optimizer 140, as described above in the context of device 100. Tricuspid flow optimizer 440 may be connected to threaded shaft 419. Tricuspid flow optimizer 440 may be supported in the proximal direction via threaded shaft 419 through fusion / atrial wall anchoring mechanism 410.

[0218] although Figures 22A-23B Shaft 419 is shown as threaded, but shaft 419 can be threaded and / or unthreaded, without limitation. Anchoring mechanism 410 can be connected to shaft 419 via any mechanism that is the same as and / or different from the thread.

[0219] Joint anchoring mechanism 410

[0220] like Figure 24A As shown, the device 400 also includes a merging anchoring mechanism 410 that extends proximally from the tricuspid valve flow optimizer 440 into the right atrium (not shown). The merging anchoring mechanism 410 may include one or more (e.g., one, two, three, four, or more) anchoring arms 415. The anchoring arms 415 may have the same or separate shape and / or length. Figure 24B (As shown in the image). Figures 26-28As shown, when deployed, the distal (or distal) end regions 416 of arms 415a-415c engage with the tissue wall of the tricuspid annulus at the leaflet fusion point, and the intermediate portion 417 is positioned against the inner annular wall of the right atrium to provide further retention and stabilization of the tricuspid flow optimizer 440. Preferably, arms 415a-415c are formed of a shape-memory material (e.g., NiTi) such that they self-expand upon release from the delivery catheter. As an example, Figures 29A-29B An exemplary extent of expansion of the arm 415a from the central axis of the device is shown. The arm 415a can expand to... Figures 29A-29B Any of the shapes shown and / or Figures 29A-29B Any intermediate shape between the shapes shown is acceptable to allow the merging anchoring mechanism 410 to be placed and / or fitted into a tricuspid annulus of variable shape and size. A similar range of displacement applies to arms 415a-415c. Optionally, arms 415a-415c may include a friction-enhancing layer (e.g., a polymer) on the tissue-facing surface, including, for example... And microbarbs to enhance adhesion to tissue at the fusion site and the upper wall of the inner ring. For example Figure 24B As shown, the inner core 418, threaded shaft 419, and locking ring 420 can be made of standard metal alloys or polymers.

[0221] like Figure 22A As shown, arm 415a protrudes proximally in a cylindrical shape. In other words, arm 415a includes a proximal end region comprising a cylindrical protrusion. The inner core 418 may be located within the cylindrical shape protruding from arm 415a. Figure 22A As shown, the snap-fit ​​edge 421 on the inner core 418 is designed to mate with the notch 422 of the arm 415a, axially interlocking these components while still allowing limited rotation of the inner core 418 within the arm 415a. Figure 22B neutralization Figure 22D As shown, arm 415b is fitted into inner core 418 within a matching groove 464 defined on inner core 418, allowing the combined rotation of arm 415b and inner core 418. Figure 22C As shown, arm 415c protrudes proximally in the central portion of a cylindrical shape. The central portion of arm 415c can be inserted into the inner core 418 by engaging in a groove 423 defined on the inner core 418, allowing arm 415a to rotate independently of the inner core 418. Clockwise (CW) and / or counterclockwise (CCW) rotation of arm 415b can be limited by the edge of the groove 423 on the inner core 418, within which the central portion of arm 415c engages.

[0222] like Figures 30A-30CAs shown, arm 415c can be moved radially by rotating the proximal end region CW or CCW of arm 415c. The proximal end region of arm 415c protrudes through locking ring 420. Similarly, as Figures 31A-31C As shown, arm 415b can be moved radially by clockwise or counterclockwise rotation along the proximal end region of the inner core 418 protruding from the threaded shaft 419. Figures 32A-32E As shown in the atrial view, by rotating the inner core 418 and / or the proximal end region of arm 415c, the operator can individually position arms 415a-415c at different relative angles to match the angles on the natural commissure of the tricuspid valve leaflets. Rotation of arms 415a-415c can be controlled via the device delivery system before (e.g., before loading device 400 into the delivery catheter) and / or during (e.g., before loading device 400 into the delivery catheter) the procedure.

[0223] The threaded shaft 419 supports the flow optimizer 440 and passes through the inner core 418, as... Figure 23A and Figure 23B As shown. (As illustrated) Figures 33A-33B As shown, rotation of the CW and / or CCW of the distal end region of the threaded shaft 419 can cause the distally connected flow optimizer 440 to move axially in the distal and proximal longitudinal directions, allowing the relative distance between the flow optimizer 440 and the connecting anchoring mechanism 410 to shorten or lengthen, and / or change the radial orientation of the flow optimizer 440 relative to the anchoring arms 415a-415c.

[0224] like Figure 34A and Figure 34B As shown, the locking ring 420 is positioned on the proximal end of the anchoring mechanism 410, above the inner core 418 and the arm 415c. Figure 34C and Figure 34D As shown, the proximal surface 424 of the locking ring 420 can move distally until it mates with the proximal cylindrical surface 425 of the arm 415a. The proximal surface 424 of the locking ring 420 can engage the bayonet engagement edge 426 of the inner core 418. In this position, the locking ring 420 presses the arm 415a onto the inner core 418 while radially constraining the proximal ends of the arm 415c and the inner core 418 onto the threaded shaft 419, thus simultaneously locking the relative radial and axial positions of the inner core 418, the arms 415a-bc, and the threaded shaft 419.

[0225] Optionally, the anchoring mechanism 410 can be coupled to a height adjustment mechanism to allow discrete, individual control over the expansion or contraction of each arm 415. In one embodiment, Figure 35 - Figure 38As illustrated, the end regions (or distal end regions) and / or intermediate portions of the anchoring arms 415a-415c can be connected to cable 431. The proximal end of cable 431 is connected to slider 432. The longitudinal cross-sectional profile of slider 432 is configured to mate with the longitudinal cross-sectional profile of a notch 433 cut along the cylindrical protrusion of arm 415a. The expansion or contraction of arms 415a-415c relative to the central axis of the anchoring mechanism can be individually controlled by moving slider 432 longitudinally along arm 415a distally or proximally, causing stop 434 to disengage from and re-engage with slider 432, as shown in the figure. Figures 39A-39B As shown in the illustration. In one embodiment, the stop 434 is configured to allow sliding in both distal and proximal directions. Alternatively, the unidirectional stop 434 is configured to allow displacement in a distal direction (e.g., toward the ventricle) or a proximal direction (e.g., toward the atrium).

[0226] Deployment of the commissural / atrial wall support device 400

[0227] Similar to the deployment of device 100, device 400 can be loaded into intravascular catheter 450, such as... Figure 40A and Figure 40B As shown, the fluid is delivered to the right atrium and into the tricuspid valve via a transfemoral artery access through the IVC or a right internal jugular vein access through the IVC. Once positioned within the tricuspid valve, the distal end of the external lumen 451 can be partially retracted to allow for the expansion of the flow optimizer 440 and partial opening of the anchoring arm 415. Figure 41A As shown in the diagram. Under standard visualization techniques (e.g., angiography, fluoroscopy, echocardiography), the radial position of arm 415c can be determined by adjusting the intermediate cavity 452 of the delivery system. Figure 42B As shown, the CW or CCW rotation is used to modify the intermediate cavity 452 via the slider 453. Figure 42A (As shown in the figure) is connected to the proximal end of arm 415c.

[0228] like Figure 43A As shown, the slider 455 on the inner cavity 454 can be advanced to engage the mating notch 456 at the distal end region of the inner core 418. Figure 43B As shown, the radial position of arm 415b can be modified by rotating the inner cavity 454CW or CCW of the conveying system.

[0229] Once the anchoring arm 415 is aligned with the leaflet fusion of the natural valve, the slider 455 on the lumen 454 can be retracted by the operator, thus disengaging from the rotational control of the arm 415b, and the height and orientation of the flow optimizer 440 can then be changed by rotating the lumen 454CW or CCW. Figure 44As shown, the position of the locking anchor arm and flow optimizer 440 can be achieved by sliding the slider 453 to the distal side and advancing the locking ring 420 until it engages with the arm 415a.

[0230] The external cavity 451 can be further retracted to allow the anchoring arm 415 to fully reach the tricuspid annulus at the commissure of the leaflets and / or at the superior wall of the right atrium. For example Figures 45A-45B As shown, the catheter operator can rotate the inner lumen 454 (e.g., CCW) to disengage it from the threaded shaft 419, thereby allowing the release device and retraction of the delivery system catheter. Optionally, an additional outer lumen (not shown) with three separate sliders (not shown) can be added to the delivery system to allow the operator to modify the position of slider 432 (in... Figures 39A-39B (as shown in the diagram), and thus control the expansion and / or contraction of each individual anchor arm 415.

[0231] The disclosed embodiments are susceptible to various modifications and alternative forms, and specific examples of these have been shown by way of example in the accompanying drawings and described in detail herein. However, it should be understood that the disclosed embodiments are not limited to the specific form or method disclosed, but rather, the disclosed embodiments will cover all modifications, equivalents, and alternatives.

[0232] This disclosure relates to a device for assisting heart valves, comprising:

[0233] A flow optimizer, configured to be located within the valve and having a cross-sectional area that reduces the valve's reflux orifice during cardiac contraction; and

[0234] An anchoring mechanism is connected to the flow optimizer and configured to fix the position of the flow optimizer relative to the valve.

[0235] In one embodiment, the cross-sectional area during cardiac contraction is greater than the cross-sectional area during cardiac diastole.

[0236] In one implementation, the traffic optimizer includes:

[0237] A frame comprising a plurality of arms, each arm including a first end region and a second end region, the first end regions of the plurality of arms being connected at a common joint, and the second end regions extending radially from the common joint; and

[0238] A cover, which is attached to the plurality of arms and extends between adjacent arms, defines the cross-sectional area of ​​the flow optimizer.

[0239] In one embodiment, the covering collapses at least partially in the direction of hemodynamic flow during cardiac diastole.

[0240] In one embodiment, the frame has a conical shape, and the first end regions of the plurality of arms are connected at the central axis of the conical shape.

[0241] In one embodiment, the conical shape has a base adjacent to the ventricle of the heart and a apex adjacent to the atrium of the heart.

[0242] In one embodiment, the covering includes a plurality of leaflets, each leaflet being arranged concentrically around the central axis.

[0243] In one embodiment, the plurality of leaflets includes two or more leaflets, the two or more leaflets including a first leaflet and a second leaflet that at least partially overlap.

[0244] In one embodiment, the first lobule and the second lobule are opened to define a gap for hemodynamic flow during cardiac diastole.

[0245] In one embodiment, the first lobule and the second lobule are located proximal and distal to the central axis, respectively, and the atrium-facing surface of the first lobule at least partially overlaps the ventricle-facing surface of the second lobule.

[0246] In one embodiment, the covering expands at least partially toward the natural valve leaflets during cardiac contraction.

[0247] In one embodiment, the covering at least partially blocks the reflux port during cardiac contraction.

[0248] In one embodiment, the anchoring mechanism includes one or more anchoring arms, each anchoring arm including a proximal end region connected at the central axis of the anchoring mechanism and a distal end region extending from the central axis of the anchoring mechanism, the distal end region of the anchoring arm being configured to be located at the commissure of the natural valve leaflets.

[0249] In one embodiment, the distal end region is configured to engage with the annulus of the valve at the junction.

[0250] In one embodiment, each of the one or more anchoring arms is configured to have a shape expansion range and a ring geometry adapted to the valve at the junction.

[0251] In one embodiment, the anchoring arm is configured to rotate about the central axis of the anchoring mechanism.

[0252] In one embodiment, the one or more anchoring arms rotate about the central axis of the anchoring mechanism to match the angular distribution of the engagement.

[0253] In one embodiment, the one or more anchoring arms include a first anchoring arm, the proximal end region of which includes a cylindrical protrusion aligned with the central axis of the anchoring mechanism.

[0254] In one embodiment, the one or more anchoring arms include a second anchoring arm, the proximal end region of which is fixedly connected to an inner core enclosed in the cylindrical protrusion, and the inner core is configured to rotate about the central axis of the anchoring mechanism relative to the cylindrical protrusion.

[0255] In one embodiment, rotating the inner core relative to the cylindrical protrusion changes the angle between the first anchor arm and the second anchor arm.

[0256] In one embodiment, the one or more anchoring arms include a third anchoring arm, the proximal end region of which includes a central portion located between the cylindrical protrusion and the inner core, and is configured to rotate relative to the inner core about the central axis of the anchoring mechanism.

[0257] In one embodiment, rotating the proximal end region of the third anchoring arm relative to the inner core changes the angle between the second and third anchoring arms.

[0258] In one embodiment, the anchoring mechanism includes a locking ring configured to secure the relative positions between the one or more anchoring arms.

[0259] In one embodiment, the anchoring arm is configured to rotate before being loaded into the catheter, after being deployed in the heart via the catheter, or a combination thereof.

[0260] In one embodiment, the one or more anchoring arms include three anchoring arms, each of which has its distal end region configured to be located at the respective commissure of a natural valve leaflet.

[0261] In one embodiment, each of the one or more anchoring arms includes an intermediate region between the proximal end region and the distal end region, the intermediate region being configured to rest against the inner annular upper wall of the atrium.

[0262] In one embodiment, the anchoring mechanism includes a height adjustment mechanism configured to individually control the shape of each of the one or more anchoring arms.

[0263] In one embodiment, the height adjustment mechanism includes a cable having a proximal end region slidably connected to a proximal end region of a first anchor arm among the one or more anchor arms, the proximal end region of the first anchor arm being aligned with the central axis of the anchoring mechanism, and the cable having a distal end region connected to a distal extension of a selected anchor arm among the one or more anchor arms.

[0264] In one embodiment, the device further includes a shaft connecting the flow optimizer and the anchoring mechanism.

[0265] In one embodiment, the shaft is threaded, such that rotation of the shaft relative to the anchoring mechanism changes the distance between the flow optimizer and the anchoring mechanism.

[0266] In one embodiment, the shaft is threaded, such that rotation of the shaft relative to the anchoring mechanism alters the radial orientation of the flow optimizer relative to the anchoring mechanism.

[0267] In one embodiment, the anchoring mechanism includes a locking ring configured to fix the relative position between the flow optimizer and the anchoring mechanism.

[0268] In one embodiment, the shaft is configured to rotate relative to the anchoring mechanism before being loaded into the catheter, to rotate relative to the anchoring mechanism after being deployed in the heart via the catheter, or a combination thereof.

[0269] In one embodiment, each of the flow optimizer and the anchoring mechanism has a bundle configuration suitable for being loaded in a catheter and a deployment configuration suitable for deployment in the heart.

[0270] In one embodiment, the anchoring mechanism includes an anchoring device coupled to the flow optimizer and configured to anchor to the vena cava.

[0271] In one embodiment, the anchoring mechanism includes an atrial anchor connected to the flow optimizer and configured to be anchored to the atrial wall.

[0272] In one embodiment, the anchoring mechanism includes a ventricular anchor coupled to the flow optimizer and configured to be anchored to the ventricular wall.

[0273] This disclosure also relates to a device for implantation, comprising:

[0274] An anchoring mechanism comprising one or more anchoring arms, each arm including a proximal end region connected at a central axis and a distal end region extending from the central axis, the distal end regions being configured to be located at the juncture of the natural leaflets of the heart valve; and

[0275] An implant that is connected to and anchored to the valve via the anchoring mechanism.

[0276] In one embodiment, the distal end region is configured to engage with the annulus of the valve at the junction.

[0277] This disclosure also relates to a method for deploying a device for supporting the function of heart valves, comprising:

[0278] The distal end region of the catheter is delivered to the valve, wherein the device is loaded in the catheter;

[0279] The flow optimizer of the device is expanded within the valve by partially retracting the catheter proximally; and

[0280] The device's anchoring mechanism is opened by retracting the catheter at least partially proximally; the anchoring mechanism is coupled to the flow optimizer and configured to fix the position of the flow optimizer relative to the valve.

[0281] In one embodiment, the anchoring mechanism includes one or more anchoring arms, each anchoring arm including a proximal end region connected at a central axis and a distal end region extending from the central axis, wherein opening includes partially opening the one or more anchoring arms.

[0282] In one embodiment, after partially opening the one or more anchoring arms, the method further includes aligning the one or more anchoring arms with the fusion of the natural leaflets of the valve.

Claims

1. A device for implantation, comprising: An anchoring mechanism comprising a plurality of anchoring arms, each anchoring arm including a proximal end region on a central axis of the anchoring mechanism and a distal end region extending from the central axis, the distal end regions being configured to be located at the junction of the natural leaflets of a heart valve; wherein a first anchoring arm of the plurality of anchoring arms is configured to rotate about the central axis of the anchoring mechanism relative to a second anchoring arm of the plurality of anchoring arms; and A flow optimizer, which is connected to and anchored to the valve via the anchoring mechanism. The flow optimizer includes multiple leaf layers, which include a first leaf layer and a second leaf layer that overlap at least partially, and the multiple leaf layers are arranged concentrically around the central axis of the flow optimizer.

2. The device according to claim 1, wherein the flow optimizer has a conical shape.

3. The device of claim 1, wherein the first lobule and the second lobule are configured to open a gap for hemodynamic flow between the first lobule and the second lobule during cardiac diastole.

4. The device of claim 1, wherein each of the plurality of anchoring arms is configured to have a shape expansion range and a ring geometry adapted to the junction of the heart valve.

5. The device of claim 1, wherein the proximal end region of the first anchoring arm includes a cylindrical protrusion aligned with the central axis of the anchoring mechanism.

6. The device of claim 5, wherein the proximal end region of the second anchoring arm is fixedly connected to an inner core enclosed in the cylindrical protrusion, and the inner core is configured to rotate about the central axis relative to the cylindrical protrusion.

7. The device of claim 1, wherein the anchoring mechanism includes a locking ring configured to fix the relative position between the plurality of anchoring arms.

8. The device of claim 1, wherein the anchoring mechanism has a bundle configuration suitable for being loaded in a catheter and a deployment configuration when deployed in a heart valve.

9. A device for implantation, comprising: A shaft, the shaft including a distal end region and a proximal end region; An anchoring mechanism comprising a plurality of anchoring arms, each anchoring arm extending radially away from the axis, the distal end portion of each anchoring arm being configured to be located at the junction of the natural leaflets of the heart valve. A flow optimizer, attached to the distal end region of the shaft, wherein the anchoring mechanism is configured to slide axially and rotate about the shaft, such that the relative position between the flow optimizer and the anchoring mechanism can be adjusted axially and radially. A locking ring, configured to fix the relative axial and relative radial positions between the flow optimizer and the anchoring mechanism. The flow optimizer includes a plurality of leaf layers, the plurality of leaf layers including a first leaf layer and a second leaf layer that overlap at least partially, wherein each of the plurality of leaf layers is arranged concentrically about the axis.

10. The device of claim 9, wherein the flow optimizer is configured to collapse inward during cardiac diastole and expand at least partially toward the natural leaflets of the heart valve during cardiac systole.

11. The device of claim 9, wherein the flow optimizer has a conical shape.

12. The device of claim 9, wherein the first lobule and the second lobule are configured to open a gap for hemodynamic flow between the first lobule and the second lobule during cardiac diastole.

13. The device of claim 9, wherein each of the plurality of anchoring arms is configured to have a shape expansion range and a ring geometry adapted to the junction of the heart valve.

14. The device of claim 9, wherein the proximal end portion of the first anchoring arm of the plurality of anchoring arms includes a cylindrical protrusion aligned with the central axis of the anchoring mechanism.

15. The device of claim 14, wherein the proximal end portion of the second anchoring arm of the plurality of anchoring arms is fixedly connected to an inner core enclosed in the cylindrical protrusion, and the inner core is configured to rotate about the central axis relative to the cylindrical protrusion.

16. The device of claim 9, wherein each of the flow optimizer and the anchoring mechanism has a bundle configuration suitable for being loaded in a catheter and a deployment configuration suitable for deployment in a heart valve.

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