Systems, devices, and methods for reducing heart valve regurgitation

Abstract

Embodiments described herein relate to an implant delivery system for delivering an implant to reduce heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member, such as a braided tether. A distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate member is configured to couple the implant to the implant holder and to transition the implant between configurations. The implant is configured to be disposed around a portion of a leaflet of a heart valve to improve engagement of the heart valve.

Description

Government-supported confirmation statement

[0001] This invention was made with government support under grant HL135145 granted by the National Institutes of Health. The government holds certain rights in this invention. Cross-reference to related applications

[0002] This application claims the benefit of U.S. Patent Application No. 18 / 782,496, filed July 24, 2024, entitled “Systems, Devices, and Methods for Reducing Heart Valve Regurgitation,” which claims priority to U.S. Provisional Application No. 63 / 578,923, filed August 25, 2023, entitled “Systems, Devices, and Methods for Reducing Heart Valve Regurgitation,” the disclosure of which is incorporated herein by reference. Technical Field

[0003] The embodiments described herein relate to implants and implant delivery systems for reducing valvular regurgitation. Specifically, the embodiments described herein relate to a transcatheter delivery system for delivering an implant to the mitral valve. Background Technology

[0004] Heart valve regurgitation, particularly functional mitral regurgitation (FMR), is a common valvular heart disease in patients with heart failure (HF) and has been shown to worsen the progression of HF and increase patient mortality. Most HF patients are at high risk for surgery due to poor health. Minimally invasive transcatheter methods exist for delivering implants to heart valves (e.g., the mitral valve); however, current implantation techniques do not adequately treat FMR and can disrupt native valve dynamics, resulting in poor long-term durability. Attached Figure Description

[0005] Figure 1A It shows the engagement of the heart valve (left) at the annular plane, as well as the valve annulus and ventricular cavity dilation that deform the heart valve and cause regurgitation.

[0006] Figure 1B The image shows mitral regurgitation during systole (left) and the use of implants to treat valvular regurgitation (right).

[0007] Figures 2A to 2C This is a schematic diagram of an implant delivery system according to an embodiment for reducing valvular regurgitation during different stages of implant delivery.

[0008] Figure 3 This is a schematic block diagram of an implant retainer in an implant delivery system according to an embodiment.

[0009] Figure 4 This is a schematic diagram of an implant for reducing valvular regurgitation according to an embodiment.

[0010] Figure 5A This is an illustration of an implant delivery system including a multi-lumen implant catheter and an implant retainer according to an embodiment.

[0011] Figure 5B A close-up of the distal end of the implant delivery system according to an embodiment is shown.

[0012] Figure 5C Images are of an implant delivery system including a handle assembly, an implant catheter, and an implant retainer, according to an embodiment.

[0013] Figure 6 Images are shown of the proximal control mechanism of each catheter and the maneuverability of the catheter in the implant delivery system according to an embodiment.

[0014] Figures 7A to 7C The operability of an implant delivery system comprising three catheters according to an embodiment is shown.

[0015] Figure 8 This is a diagram of an implant retainer in an implant delivery system according to an embodiment.

[0016] Figures 9A to 9C An image of an implant retainer, comprising an implant connected thereto, is shown according to an embodiment of an implant delivery system.

[0017] Figures 10 to 15 Implants for treating valvular regurgitation according to various embodiments are described.

[0018] Figures 16A to 16C A front perspective view of the implant according to an embodiment is shown. Figure 16A ), rear perspective view ( Figure 16B ) and bottom view ( Figure 16C ).

[0019] Figure 17A A front view of the implant according to an embodiment is shown. Figure 17B Demonstrates the embodiments Figure 17A Front view of the first arm of the implant. Figure 17C Demonstrates the embodiments Figure 17A Front view of the second arm of the implant body.

[0020] Figure 17D Demonstrates the embodiments Figure 17A Rear perspective view of the implant. Figure 17E Demonstrates the embodiments Figure 17A A frontal perspective view of the implant.

[0021] Figure 17F Showing Figure 17A A bottom view of the implant. Figure 17G Showing Figure 17A A side view of the implant.

[0022] Figures 18A to 18C The front perspective view, rear perspective view, and bottom perspective view of the first plate of the implant according to the embodiment are shown respectively.

[0023] Figures 19A to 19C A front view, a side view, and a bottom view of the second plate of the implant according to an embodiment are shown.

[0024] Figure 20A A top perspective view of the implant according to an embodiment is shown. Figures 20B to 20E An edge of the implant according to an embodiment is shown, at which one or more plates are welded to the implant.

[0025] Figures 21A to 21B A portion of the first arm according to an embodiment is shown, illustrating a visual marker received within the implant.

[0026] Figures 22A to 22C A cover for an implant for treating valvular regurgitation according to an embodiment is shown.

[0027] Figure 23A A top view of the cover in a flat configuration according to an embodiment is shown. Figures 23B to 23C A front view of a cover attached to an implant according to an embodiment is shown.

[0028] Figure 24 The embodiment shown is in a substantially flat configuration. Figures 17A to 17G The front view of the implant shown.

[0029] Figure 25 The embodiment shown is in a substantially flat configuration. Figures 18A to 18C The front view of the variant of the first plate shown.

[0030] Figure 26 The embodiment shown is in a substantially flat configuration. Figures 19A to 19C The front view of the variant of the second plate shown.

[0031] Figures 27A to 27B This is a front view of an implant for treating valvular regurgitation according to an embodiment.

[0032] Figure 28 These are images of implants of different sizes in the delivery configuration (bottom row) and the unfolded configuration (top row).

[0033] Figures 29A to 29F A method for delivering an implant to a heart valve using an implant delivery system according to an embodiment is shown to treat valvular regurgitation.

[0034] Figures 30A to 30D A method for delivering an implant to a heart valve using an implant delivery system according to an embodiment is shown to treat valvular regurgitation.

[0035] Figure 31 This is a flowchart of an example method for delivering an implant to treat valvular regurgitation according to an embodiment.

[0036] Figure 32 This is a flowchart illustrating an example method for delivering an implant to reduce valvular regurgitation according to an embodiment.

[0037] Figure 33 This is a flowchart of an example method for manufacturing an implant for treating valvular regurgitation according to an embodiment. Detailed Implementation

[0038] Heart valve regurgitation has been shown to worsen the progression of heart failure (HF) and increase patient mortality. First-line treatment for HF patients with heart valve regurgitation, such as mitral regurgitation, is guideline-guided drug therapy (GDMT). Drug therapy targets hemodynamics or left ventricular (LV) remodeling, rather than the valve itself, aiming to improve LV geometry and thus have a secondary effect on mitral regurgitation. Cardiac resynchronization therapy (CRT) is also used to treat mitral regurgitation in patients with prolonged QRS complexes. CRT helps synchronize LV contraction, thereby enhancing its systolic function, which in turn enhances LV closure force. FMR can often be treated surgically by repairing or replacing the valve when the patient undergoes coronary artery bypass grafting (CABG). However, most HF patients are considered too high-risk for surgery due to poor health. Therefore, these patients require minimally invasive transcatheter techniques to repair or replace the valve. Current techniques are not sufficient to adequately treat FMR and disrupt native valve dynamics, resulting in poor long-term durability.

[0039] Conversely, the embodiments described herein use a lightweight implant to enhance the leaflet at the site of regurgitation, providing leaflet extension and covering the regurgitation gap during systole; and the implant can move with the leaflet during diastole to allow unrestricted inflow. In some embodiments, the implant can locally enhance the native leaflet upon attachment. Manipulable implant delivery systems can be used for image-guided transcatheter implant deployment. The implants described herein overcome the anatomical limitations of cardiac valvular regurgitation implantation, thereby significantly expanding the patient population eligible for treatment. The embodiments described herein can use a single leaflet capture method, thus eliminating the risks of inducing functional stenosis or capturing short leaflets or limiting the possibility of future interventions on the same valve.

[0040] This document discloses devices, systems, and methods for reducing valvular regurgitation. Typically, the devices described herein (e.g., implants) are configured to attach to a heart valve, allowing alteration of the heart valve to treat a patient's heart condition, such as valvular regurgitation. The devices described herein generally include implantable devices configured to attach to one or more of cardiac tissue, such as valve leaflets, chordae tendineae, and valve annulus, to reduce or eliminate valvular regurgitation. The device may include an attachment portion and an engagement portion. The attachment portion may be configured to attach the implant to tissue, and the engagement portion may be configured (e.g., alone or in combination with the attachment portion) to enhance and / or alter one or more physical properties of the heart valve. Physical properties may include, but are not limited to, leaflet length, leaflet height, leaflet width, leaflet thickness, leaflet curvature, leaflet stiffness, leaflet shape, leaflet strength, and combinations thereof. In this way, upon implantation, the implant can enhance and / or alter one or more physical properties that can affect the movement, deformation, and / or stretching of the leaflets. The altered physical properties may affect a portion of a heart valve, or in some variations, the entire heart valve. The altered physical properties can be used to treat (e.g., partially or completely correct) heart conditions such as valvular regurgitation (e.g., functional mitral regurgitation (FMR), tricuspid regurgitation, aortic regurgitation, pulmonary regurgitation).

[0041] In some variations, one or more altered physical properties of the heart valve can reduce or eliminate the gap between the leaflets, thereby reducing or eliminating valvular regurgitation. For example, the devices described herein can alter one or more physical properties of the valve in a manner that increases the engagement surface area of ​​the valve leaflets. That is, the devices described herein can be coupled to the leaflets of the valve such that the length, thickness, and / or width of the leaflets are altered (e.g., increased). The altered length, width, and / or thickness of the leaflets provides altered engagement surfaces (e.g., increased engagement surface area) that reduce or eliminate regurgitation. For example, the devices described herein can protrude from or otherwise extend from the surface of the heart valve leaflets such that another leaflet can engage a portion of the device during systole, which can restore unidirectional blood flow through the valve. In some embodiments, the devices described herein can be coupled to the valve such that leaflet movement is altered in a manner that reduces or eliminates regurgitation.

[0042] The device described herein can offer numerous benefits. For example, the device can be configured to capture individual leaflets, which preserves the valve orifice, as opposed to edge-to-edge approaches. In some embodiments, individual leaflets can be captured when the associated valve is open (e.g., during diastole). Additionally, the device can be configured to move with the heart valve during diastole, thus not obstructing diastolic blood flow and therefore avoiding functional stenosis. In a further example, the device can be used in conjunction with valve replacement surgery (e.g., transcatheter mitral valve replacement). That is, the device can be coupled to the same valve for which valve replacement is possible without removing the coupled device and / or without requiring additional techniques or processes to adapt the coupled device, and / or advantageously modifying the valve's anatomy (i.e., increasing leaflet size) to achieve transcatheter mitral valve replacement. Furthermore, one or more physical properties of the heart valve to be modified can be specifically selected based on the characteristics of a particular patient (e.g., anatomy, severity of the condition to be treated, etc.). For example, a patient may require increased leaflet thickness, so the device described herein can modify leaflet thickness without affecting leaflet width. In a further example, the patient's valve leaflet thickness and width may require enhancement, allowing the device to facilitate both enhancements. In this way, the device can be widely used for a wide range of patients, including those with relatively small heart valves, relatively old patients, and / or patients with relatively calcified mitral annulus.

[0043] Additionally, the device described herein can be deformable, allowing it to non-destructively (e.g., damage-free) affect the structure or function of a heart valve and / or to receive a portion of the heart valve (e.g., leaflet) via engagement. For example, the device can be releasably attached to heart valve tissue (e.g., native leaflet, chordae tendineae) via compressive and / or frictional forces that do not damage the tissue. The compressive force can be applied through an attachment portion comprising a first segment or arm and a second segment or arm of the implant. In some configurations, at least a portion of each of the first segment or arm and the second segment or arm can be coplanar with each other, which can help maintain the device's position relative to the heart valve. A central member can define a portion of the engagement portion, and the engagement portion can also include one or more support members. The support members can extend from the first segment or arm and can help define a volume within the engagement portion. At least a portion of the engagement portion (e.g., at least a portion of the central member, one or more support members, or a portion thereof) can be deflectable and / or deformable upon contact with the native leaflet. For example, one or more support members can deflect and / or deform relative to one or more additional support members. By means of the deflection and / or deformation of one or more support members (e.g., two, three, four or more), the volume of the engagement portion at least partially defined by the support members can be changed (e.g., reduced) upon contact with the native leaflet, and can be restored to its pre-contact volume upon loss of contact with the native leaflet.

[0044] Furthermore, the device described herein can be adjustable, allowing the physician to change its configuration and / or position during surgery without adversely affecting the structure or function of the heart valve. For example, the device can be configured to switch multiple times between a first configuration (e.g., an implantation configuration) and a second configuration (e.g., an open configuration), and to avoid tissue damage during application to the heart valve (including during reapplication or multiple applications) during any such switching between configurations. In this way, the device can be positioned and repositioned until it is placed on the heart valve in an optimal orientation, maximizing the device's effectiveness (e.g., measured by a reduction in regurgitation). To further aid in device positioning, the device can also be visualized by the physician directly or indirectly during surgery, allowing the physician to determine the location and configuration of specific portions of the device. Thus, the adjustability and visibility of the device can reduce or eliminate the need for subsequent surgical procedures that might otherwise be required to adjust the device's position. In some variations, multiple devices can be releasably attached to the heart valve tissue simultaneously, allowing the effects of each device to be combined to optimally reduce valvular regurgitation. The device also allows for tissue embedding, enabling permanent integration into the heart valve. Tissue embedding provides additional thickness to the junction, which can improve the device's effectiveness. As tissue thickness increases over time, effectiveness may continue to increase. In this way, the effectiveness and permanence of the device described herein can reduce or eliminate the risks associated with valvular regurgitation, anticoagulant use, and / or avoidance of tissue maladaptation for patients.

[0045] The systems described herein may include implant delivery systems configured to advance an implant attached thereto into a patient. The implant delivery system may include a handle coupled to one or more catheters, each catheter including one or more lumens. One or more elongated members (e.g., guidewires, sutures, tubes) may pass through one or more lumens of the catheters. In some variations, the elongated member may include a tube including a lumen therethrough, and one or more tubes may pass through one or more lumens of the catheters. One or more additional elongated members (e.g., guidewires, sutures) may be advanced through one or more tubes. The elongated member may be operatively coupled to a first segment or arm and / or a second segment or arm of the implant, such that the first segment or arm and the second segment or arm are movable relative to each other. In some variations, the elongated member may be operatively coupled to the first segment or arm and / or the second segment or arm via a direct attachment between the elongated member and the first segment or arm and / or the second segment or arm, while in other variations, the elongated member may be operatively coupled to the first segment or arm and / or the second segment or arm via an indirect connection. For example, in some variations, the connection via indirect link may include attaching the elongated member to the first or second segment or arm via an annular elongated member (e.g., a suture loop) attached to the first or second segment or arm to which the elongated member is attached. Thus, the delivery device may facilitate positioning the implant near a target heart valve location (e.g., native leaflet, annulus, chordae tendineae), releasing the first or second segment or arm to attach the implant to the heart valve, and optionally reapplying force to the first or second segment or arm to disengage the implant from the heart valve to facilitate removal, retraction, and / or repositioning of the implant.

[0046] Figure 1AThis diagram illustrates the engagement of a left-sided heart valve (e.g., the mitral valve (MV)) at the annular plane and the dilation of the valve annulus on the right side that causes mitral regurgitation. The mitral valve is a bileaflet atrioventricular valve located between the left ventricle (LV) 10 and the left atrium (LA) of the heart. This valve has two leaflets, an anterior leaflet and a posterior leaflet 12, whose bases are attached to a fibrous structure called the annulus 12 between LV 10 and LA. The MV annulus is saddle-shaped, with high points / peaks at the anterior and posterior portions and low points at the lateral and medial commissures. The chordae tendineae (hereinafter referred to as "chordae tendineae") 14 are cord-like structures connecting the leaflets 12 to the papillary muscles and LV 10. The chordae tendineae 14 originate from the tips of the papillary muscles and insert into the ventricular side of both the anterior (AL) and posterior (PL) leaflets. Mitral regurgitation (MR) occurs when the valve leaflets 12 fail to engage during systole, causing blood to flow back through the gap formed between the leaflets. This blood backflow causes pulmonary venous congestion, leading to shortness of breath and LV10 volume overload, and is a significant contributing factor to heart failure (HF). Based on underlying pathology, functional mitral regurgitation can be broadly classified into atrial or atrial FMR and ventricular FMR.

[0047] In FMR, this physiological leaflet movement is disrupted, resulting in incomplete conjunctival closure. The dilated annulus pulls the leaflets 12 apart during diastole, and the leaflets 12 need to travel a greater distance before conjunctival closure during systole. The dyskinetic and dilated LV exerts traction on both the marginal and supporting chordae tendineae, as well as on both the anterior and posterior leaflets, preventing the leaflets from deforming sufficiently to verticalize the leaflet edges, thus forming a conjunctival ridge during systole. As shown in the figure, in a normal mitral valve, the rough area 12R of the leaflet edge 12 is vertical and forms the conjunctival ridge or closure structure during systole. In the abnormal mitral valve shown on the right, the displacement of the papillary muscles and the dilation of the annulus cause increased tension in the chordae tendineae, preventing the leaflet edge 12 from becoming vertical and forming a conjunctival ridge or closure structure.

[0048] Figure 1BThis diagram illustrates mitral regurgitation during systole (left) and the use of implant 160 to treat valvular regurgitation (right). As shown on the right, implant 160 is attached to the edge of one of the leaflets 12 at the site of regurgitation to provide the vertical ridge required for engagement. The implant 160 protrudes from the surface of leaflet 12 to locally increase the length and width at the leaflet edge 12, potentially providing sufficient leaflet 12 reserve and also reducing the degree of relative leaflet movement required for engagement. The protruding portion of the implant can be appropriately sized according to the size and characteristics of the regurgitation jet, such that this local enhancement using the implant is appropriate for the systolic regurgitation gap without interfering with valve opening during diastole to avoid the risk of stenosis. The protruding portion of the implant can also be designed to be appropriately larger according to the size and characteristics of the regurgitation jet, such that the local enhancement using the implant is greater than the systolic regurgitation gap to achieve a larger engagement reserve without interfering with valve opening during diastole to avoid the risk of stenosis.

[0049] Figures 2A to 2C This is a schematic diagram of an implant delivery system 100 for reducing valvular regurgitation during different stages of implant delivery 160, according to an embodiment. The implant delivery system 100 may include one or more catheters and a handle assembly coupled to the proximal end of one or more catheters. In some embodiments, the implant delivery system 100 may include an implant catheter (IC) 130 extending alongside or through the inner lumen of a delivery catheter (DC) 120. The delivery catheter 120 may extend alongside or through the inner lumen of a guiding catheter (GC) 110. The distal end of the implant catheter 130 may be coupled to an implant retainer 135, which includes a cavity configured to receive the implant 160.

[0050] At least one of the implant catheter 130, delivery catheter 120, or guiding catheter 110 may be steerable (e.g., articulated in one or more planes) to navigate the implant delivery system 100 to the leaflets of a heart valve, such that the implant 160 can be secured to the leaflets. In some embodiments, the delivery catheter 120 and guiding catheter 110 may be steerable to position the implant near the patient's heart valve. In some embodiments, the implant catheter 130 may be non-steerable. For example, the stiffness of the implant catheter 130 may be less than that of the delivery catheter 120, such that a portion of the implant catheter 130 disposed within the delivery catheter 120 bends or kinks along with the delivery catheter 120. Figure 2B As shown, the implant catheter 130, delivery catheter 120, and guiding catheter 110 can be configured to guide the implant retainer 135 through the patient's left atrium LA, across the valve leaflet L, and at least partially into the left ventricle LV, such that the implant 160 can be secured to the leaflet of the mitral valve.

[0051] In some embodiments, the guiding catheter 110 may be able to bend along a plane (e.g., a first plane) from its longitudinal axis to angles up to 90, 100, 120, 135, 145, and 150 degrees. In some embodiments, the delivery catheter 120 may be configured to bend along one or more planes (e.g., along a first plane and a second plane perpendicular to the first plane). In some embodiments, the delivery catheter 120 may be configured to bend along the first plane from its longitudinal axis to angles up to about 110, 120, 130, 140, 150, 160, 170, 180, and 190 degrees. In some embodiments, the delivery catheter 120 may be configured to bend along a second plane from its longitudinal axis to angles up to about 30, 40, 45, 50, 55, and 60 degrees. In some embodiments, the guiding catheter 110 may bend to angles up to about 135 degrees to access the left atrium. In some embodiments, the delivery catheter 120 may bend to an angle of up to about 120 degrees to help direct the implant 160 toward the valve and approach different valve segments. In some embodiments, the implant catheter may be non-manipulable. In some embodiments, the implant catheter 130 may be configured to translate linearly (e.g., proximally and distally) relative to the delivery catheter 120 to position the implant 160 near or on the leaflet. In some embodiments, the implant catheter 130 may be configured to translate linearly up to distances of about 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, including all ranges and subranges therebetween.

[0052] In some embodiments, delivery catheter 120 may be configured to rotate about its own longitudinal axis (e.g., between about 180 degrees and about 360 degrees). In some embodiments, implantation catheter 130 may be configured to rotate about its own longitudinal axis. This rotation allows deployment on the anterior or posterior leaflet of a heart valve. In some embodiments, catheters 110, 120, 130 may be formed of any suitable material, such as nylon, polyethylene, nylon / polyethylene, Pebax®, etc. In some embodiments, catheters 110, 120, 130 may be extruded. In some embodiments, catheters (e.g., steerable catheters 120, 130) may be extruded to have a metal ring along the length of the catheter (e.g., at the distal end) and one or more drawstrings attached to the ring. In some embodiments, catheters (e.g., steerable catheters 120, 130) may include two drawstrings attached to the ring with a predetermined separation (e.g., about 180 degrees) such that the tension of each drawstring causes the catheter to hinge along a plane. In some embodiments, catheters 110, 120, and 130 may include any number of drawwires spaced at any intervals around the circumference of a ring. In some embodiments, catheters 110, 120, and 130 may include 1 drawwire, 2 drawwires, 3 drawwires, 4 drawwires, 5 drawwires, 6 drawwires, 7 drawwires, and 8 drawwires. The drawwires may extend along the length of the respective catheter (e.g., maneuverable catheters 120, 130) and be anchored to an actuator (e.g., GC actuator 112, DC actuator 122, and / or IC actuator 132, described in further detail below) on the proximal end of the implant delivery system 100. In some embodiments, the actuator may be any suitable actuator, such as, for example, a rack and pinion, a gear system, a knob, a slider, etc. In some embodiments, the actuator may allow a user to manipulate catheters 120 and 130.

[0053] In some embodiments, at least one of catheters 110, 120, and 130 may include a port (e.g., a flushing port) connected to the inner lumen of catheters 110, 120, and 130. This port may allow fluid to be introduced to reduce frictional contact between catheters 110, 120, and 130 and / or to remove air or prevent air from entering the patient's circulatory system. In some embodiments, a valve (e.g., a hemostatic valve) may be included in a handle assembly proximal to the port to close the proximal end of catheters 110, 120, and 130 and prevent blood leakage.

[0054] In some embodiments, catheters 110, 120, and 130 have varying stiffness or hardness along their length. For example, catheters 110, 120, and 130 may include a harder material at the proximal end, transitioning to a softer material at the distal end to allow the softer portion to bend while holding the harder portion in place. In some embodiments, stiffness or hardness may be measured using a Shore hardness scale, where “D” refers to the exponent of the Shore hardness scale. In some embodiments, the stiffness of guide catheter 130 may transition from about 45D to about 80D at the proximal end to about 15D to about 35D at the distal end. In some embodiments, the stiffness of delivery catheter 120 may transition from about 45D to about 80D at the proximal end to about 15D to about 35D at the distal end. In some embodiments, the stiffness of implant catheters may be less than 35D. In some embodiments, the stiffness of implant catheters may be less than 25D. In some embodiments, catheters 110, 120, and 130 may have column strength to be introduced and advanced into the vascular system, while also having flexibility to articulate with respect to the geometry of the heart. In some embodiments, the bending length of the guiding catheter 110 (e.g., the length of the catheter configured to bend or the length of the maneuverable portion) may range from about 10 mm to about 140 mm, including all ranges and subranges therein. In some embodiments, the bending length of the guiding catheter 110 may range from about 30 mm to about 110 mm, including all ranges and subranges therein. In some embodiments, the bending length of the guiding catheter 110 may be about 100 mm. In some embodiments, the bending length of the delivery catheter 120 may range from about 10 mm to about 90 mm, including all ranges and subranges therein. In some embodiments, the bending length of the delivery catheter 120 may be about 55 mm. In some embodiments, the bending length of the delivery catheter may be about 37 mm.

[0055] In some embodiments, the implant delivery system may include only two maneuverable catheters, and the implant retainer may be directly coupled to one of the maneuverable catheters (e.g., a dual-catheter delivery system). The guiding catheter 610 may include a proximal portion with a hardness between about 60D and 65D (e.g., 63D), an intermediate portion with a hardness between about 50D and 60D (e.g., 55D), and a distal portion with a hardness between about 20D and 30D (e.g., 25D). In some embodiments, the guiding catheter 610 may have a gradual transition between hardness levels. The delivery catheter 620 may include a proximal portion with a hardness between 60D and 65D (e.g., 63D) and a distal portion with a hardness between 30D and 40D (e.g., 35D).

[0056] In some embodiments, catheters 110, 120, and 130 may be visible on fluoroscopy and echocardiography to aid in navigation of the implant delivery system 100. In some embodiments, the distal tip of the guiding catheter 110 may include a radiopaque marker, such as a loop comprising a radiopaque material. In some embodiments, the cannula of the delivery catheter 120 may include a radiopaque marker disposed at or near the distal tip of the delivery catheter 120. In some embodiments, the implant retainer 135 may include a radiopaque marker at its distal tip. In some embodiments, one or more radiopaque markers may be disposed at a predetermined distance from the distal end of the guiding catheter 110. For example, the predetermined distance from the distal end of the guiding catheter may be about 2.5 mm, about 5 mm, about 7.5 mm, about 9 mm, about 10.5 mm, about 13 mm, about 14.5 mm, about 17 mm, about 18.5 mm, or about 20 mm. In some embodiments, one or more radiopaque markers may be disposed at a predetermined distance from the distal end of the delivery system. For example, the predetermined distance from the distal end of the delivery catheter 120 may be about 2.5 mm, about 5 mm, about 7.5 mm, about 9 mm, about 10.5 mm, about 13 mm, about 14.5 mm, about 17 mm, about 18.5 mm, or about 20 mm. In some embodiments, the delivery catheter 110 may include two radiopaque markers disposed thereon: a first radiopaque marker disposed about 5 mm from the distal end and a second radiopaque marker disposed about 20 mm from the distal end.

[0057] In some embodiments, the proximal end of the implant delivery system 100 may include a handle assembly. The handle assembly may include one or more actuators (e.g., buttons, levers, triggers, linear sliders, knobs, wheels, etc.) configured to control the configuration of the implant 160 and / or the articulation of catheters 110, 120, 130. In some embodiments, the handle assembly may include a GC actuator 112 coupled to the guide catheter 110 (e.g., and one or more drawstrings) and configured to articulate the guide catheter 110 during navigation of the implant delivery system 100 and / or delivery of the implant 160. In some embodiments, the handle assembly may include a DC actuator 122 coupled to the delivery catheter 110 (e.g., and one or more drawstrings) and configured to articulate the delivery catheter 120 during navigation of the implant delivery system 100 and / or delivery of the implant 160. In some embodiments, the handle assembly may include an IC actuator 132 coupled to the implant catheter 130 and configured to articulate and / or linearly (e.g., proximal and / or distally) move the implant catheter 130 relative to the steerable catheters 120, 130 during navigation of the implant delivery system 100. In some embodiments, the three catheters 110, 120, 130 may work together to adapt to the geometry of the vascular system and the heart to deliver the implant 160 to a target heart valve.

[0058] In some embodiments, implant 160 may include a central member coupled to a first segment or arm and a second segment or arm. In some embodiments, implant 160 may also include one or more support members, one or more positioning openings, and / or one or more friction elements. Implant 160 may be configured to move between one or more configurations, including a delivery configuration, an open configuration, a closed configuration, and an implantation configuration. For example, implant 160 may move from a delivery configuration in which the first arm and the second arm are substantially coplanar and one or more support members are in a partially or fully extended shape (e.g., an elongated state) and / or a partially or fully collapsed shape (e.g., a compressed state) to an open configuration in which the first arm and the second arm are separated from each other. Implant 160 may move between an open configuration and an implantation configuration in which the first arm and the second arm are positioned around a leaflet and apply clamping force to the leaflet. In some embodiments, implant 160 may be in a closed configuration in which each of the first arm and the second arm is substantially coplanar with each other. In this manner, the implant 160 in the open configuration can be positioned around a portion of the leaflet of the heart valve, and the implant 160 in the closed configuration can apply clamping forces to the leaflet to secure the implant 160 to the leaflet. In some embodiments, the implant 160 may include a cover disposed around a central member to prevent damage to the leaflet tissue and / or promote tissue growth. Reference Figure 4and Figures 10 to 29F Implant 160 is described in further detail.

[0059] In some embodiments, the implant catheter 130 may define one or more lumens extending therethrough. In some embodiments, one or more elongated members (e.g., guidewires, sutures, tethers, braids, etc.) may pass through one or more lumens of the implant catheter 130, extending from the proximal end to the distal end of the implant catheter 130. In some embodiments, four thiopanles may be disposed within the implant catheter 130. Each thiopanle may define a lumen in which a portion of the elongated member may be disposed. In some embodiments, the thiopanles may be formed of a material that prevents deformation or friction with one or more elongated members. In some embodiments, the thiopanles may comprise metals or metal alloys such as stainless steel or nitinol, or polymers such as nylon, polyethylene, polyurethane, polyimide, etc. In some embodiments, one or more elongated members may be formed of electropolished nitinol or polymers such as Teflon, polyethylene, Kevlar, etc. In some embodiments, the thiopanles may have a diameter corresponding to the diameter of the elongated member. For example, in some embodiments, the sodium hypochlorite tube may each have an inner diameter ranging from about 0.010 inches to about 0.015 inches (inclusive of all ranges and subranges therebetween). In some embodiments, the sodium hypochlorite tube may have an outer diameter ranging from about 0.015 inches to about 0.021 inches (inclusive of all ranges and subranges therebetween). In some embodiments, the sodium hypochlorite tube may have an inner diameter of 0.012 inches. In some embodiments, the sodium hypochlorite tube may have an outer diameter of 0.018 inches.

[0060] In some embodiments, one or more elongated members may include an atrial tether (AT) 140 and a ventricular tether (VT) 150. In some embodiments, the atrial tether 140 and the ventricular tether 150 may each form a loop that is detachably coupled to a portion of the implant 160 (e.g., through one or more openings defined by the implant 160). In some embodiments, the atrial tether 140 and the ventricular tether 150 may extend through at least a portion of the implant retainer 135 and may secure the implant 160 within a cavity of the implant retainer 135. Each of the atrial tether 140 and the ventricular tether 150 may include a first end and a second end coupled to the proximal end of the implant delivery system 100 such that each forms a loop (e.g., about 0.005 inches in diameter) at the distal end of the implant delivery system 100. For example, a portion of the atrial tether 140 and the ventricular tether 150 may extend along the length of the implant catheter 130 within each hypotube, wherein their first and second ends are anchored to a handle. In some embodiments, the second end of the atrial tether 140 and / or the second end of the ventricular tether 150 may not be connected to the handle, but may be connected to the portion of the tether 140, 150 distal to the handle.

[0061] In some embodiments, the handle assembly may further include an AT actuator 142 coupled to an atrial tether 140 and a VT actuator 152 coupled to a ventricular tether 150. The AT actuator 142 and VT actuator 152 may be configured to control the configuration of the atrial tether 140 and the ventricular tether 150 (e.g., applying / releasing tension on the tethers, disengaging the tethers from the implant 160, etc.). In some embodiments, the AT actuator 142 and VT actuator 152 may each include linear sliders coupled to the atrial tether 140 and the ventricular tether 150, respectively, such that tension is applied to the atrial tether 140 and the ventricular tether 150, respectively, when each of the AT actuator 142 and the VT actuator 152 moves proximally.

[0062] In some embodiments, the atrial tether 140 and the ventricular tether 150 may be configured to manipulate the implant 160 into different configurations when tension is applied to the atrial tether 140 and / or the ventricular tether 150 (e.g., via the AT actuator 142 and / or the VT actuator). For example, the atrial tether 140 may be operatively coupled to a first segment or arm (e.g., an atrial arm) of the implant 160, and the ventricular tether 150 may be operatively coupled to a second segment or arm (e.g., a ventricular arm) of the implant 160. In this manner, a physician may manipulate the AT actuator 142 and / or the VT actuator 152 (e.g., pull a trigger, move a linear slider proximally, or rotate a knob in a first direction) to retract the atrial tether 140 and / or the ventricular tether 150, which may pull the first and second segments of the implant 160 apart from each other. In some embodiments, the AT actuator 142 may be actuated or held in place such that a first segment or arm (e.g., an atrial arm) of the implant 160 is stabilized. When the atrial arm of the implant 160 is stabilized, the VT actuator 152 may be actuated to tighten the ventricular tether 150, causing a second segment or arm (e.g., a ventricular arm) of the implant 160 to move away from the first segment or arm. This can be performed by a physician when the implant 160 is in the patient's body and near the target heart valve location (e.g., native leaflet, annulus, chordae tendineae), allowing the implant 160 to surround the valve tissue. The physician may release the VT actuator (e.g., stop pulling the trigger, move the linear slider distally, or rotate the knob in a second direction) to release the ventricular tether 150, which may cause the first segment or arm and the second segment or arm of the implant 160 to move toward each other and engage the first segment or arm and / or the second segment or arm to the heart valve tissue.

[0063] In some embodiments, the distance traveled or moved by the actuator (e.g., AT actuator 142 and / or VT actuator 152) may correspond to the degree of opening of the implant 160 (e.g., the angle between the first segment or arm and the second segment or arm). In embodiments where the actuator is a linear slider, the distance moved by the linear slider corresponds to the degree of opening of the implant 160. In some embodiments, the maximum length traveled by the linear slider may be in the range of about 5 mm to about 50 mm, including all ranges and subranges therein. In some embodiments, the maximum length traveled by the linear slider may be about 15 mm. In some embodiments, a linear movement of about 5 mm may correspond to an increment of about 45 degrees in the opening between the segments or arms of the implant 160. In embodiments where the actuator is a knob, the degree of rotation of the knob may correspond to the degree of opening of the implant 160. In some embodiments, the actuator may be hybrid, converting knob movement into linear translational movement.

[0064] In some embodiments, the proximal end of the implant delivery system 100 may include one or more stop members for precisely controlling the articulation of the implant 160. In some embodiments, the stop members may be positioned at predetermined locations along the length of the sliding path of the AT actuator 142 and / or the VT actuator 152, such that the implant 160 may be opened or closed only by a predetermined amount and / or to indicate to the user (e.g., tactically) the degree to which the implant 160 has been opened and / or closed. The stop members may be protrusions, grooves, notches, pawls, openings, slots, etc., configured to engage the actuators to prevent movement beyond a predetermined amount. For example, in some embodiments, a portion of the AT actuator 142 and / or a portion of the VT actuator 152 may have a shape complementary to the sliding path on the proximal end of the implant delivery system 100 to indicate to the user the degree to which the implant 160 has been opened or closed. In some embodiments, the stop members may at least temporarily stop or prevent movement of the AT actuator 142 and / or the VT actuator 152. In some embodiments, the stop member may be provided along the length of the sliding path to indicate that the interarm angle of the implant 160 is 0 degrees, 45 degrees, 90 degrees and / or 120 degrees.

[0065] like Figure 2C As shown, once the implant 160 is clamped onto a portion of the valve leaflet L, the atrial tether 140 and / or ventricular tether 150 can be manipulated (e.g., loosened, relieved of tension) to move the implant 160 away from the cavity of the implant retainer 135, allowing the physician to monitor the placement of the implant 160 without disengaging it from the implant delivery system 100. This allows for real-time assessment of regurgitation correction; it allows the implant to engage freely without completely disengaging it from the implant delivery system 100. If adjustments are required, the tethers can be tightened to convert the implant 160 to its open configuration, sufficient to release the implant 160 from the valve leaflet L and pull it back into the cavity of the implant retainer 135, and the implant 160 can be repositioned using the tethers 140, 150. Once placement of the implant 160 is confirmed by establishing adequate engagement between the heart valve and the implant 160, the atrial tether 140 and ventricular tether 150 can be detached from the implant 160, and the implant delivery system 100 can be guided out of the heart to attach the implant 160 to the valve leaflet L. To completely detach the implant 160 from the implant catheter 130, the anchor can be removed or otherwise detached to release the tethers 140, 150, and the loops can be pulled out by the user. For example, one end of the tether can be released from the proximal end of the delivery system, and a second end of the tether can be pulled proximally until the first end is pulled through the arm of the implant.

[0066] Figure 3This is a schematic block diagram of an implant retainer 335 of an implant delivery system according to an embodiment. In some embodiments, the implant retainer 335 may include a proximal portion, a central portion, and a distal portion. The proximal portion may include a first cross-sectional area, the central portion may include a second cross-sectional area, and the distal portion may include a third cross-sectional area. The second cross-sectional area may be smaller than the first and second cross-sectional areas, such that the central portion forms a cavity 337. The implant retainer 335 may define a cavity 337 in the central portion, the cavity being configured to receive at least a portion of the implant 360 during navigation and delivery to a heart valve. In some embodiments, the distal portion of the implant retainer 335 may form a non-damaging tip (e.g., blunt, rounded, etc.) to prevent damage to tissue during delivery of the implant 360. In some embodiments, the implant retainer 335 may have a straight distal tip to increase torque length. In some embodiments, the implant retainer 335 may define one or more atrial passages 336 and one or more ventricular passages 338. Atrial passages 336 and ventricular passages 338 may extend along a portion of the length of implant retainer 335. In some embodiments, implant retainer 335 may include two atrial passages (e.g., a first atrial passage and a second atrial passage) and two ventricular passages 338 (e.g., a first ventricular passage and a second ventricular passage). In some embodiments, each atrial passage 336 defines an opening proximal to the implant retainer 335, and each ventricular passage 338 defines an opening distal to the implant retainer 335. One or more atrial tethers 340 may extend through the atrial passages 336, and one or more ventricular tethers 350 may extend through the ventricular passages 338. In some embodiments, a first portion of an atrial tether 340 may extend through the first atrial passage, and a second portion of an atrial tether 340 may extend through the second atrial passage, such that a loop is formed between the openings of the first and second atrial passages. In some embodiments, a first portion of the ventricular tether 350 may extend through a first ventricular passage, and a second portion of the ventricular tether 350 may extend through a second ventricular passage, such that a loop is formed between the opening of the first ventricular passage and the opening of the second ventricular passage.

[0067] In some embodiments, a loop of the atrial tether 340 may be disposed through a first portion of the implant 360 (e.g., an opening defined by the atrial arm of the implant 360) to attach the atrial arm to the atrial tether 340. For example, a first end of the atrial tether 340 may be secured proximally, and a second end of the atrial tether may be disposed through the opening of the implant 360 and fed to the proximal end of the implant catheter via the implant catheter. The atrial tether 340 may be configured to stabilize the position of the implant 360 relative to the implant retainer 335. The first and second atrial channels may have unequal lengths, such that each atrial channel 336 defines an opening at a different location on the implant retainer 335. The length of each atrial channel 336 may correspond to a corresponding predetermined region of the atrial arm of the implant 360, such that the atrial tether 340 is attached to the atrial arm of the implant 360 at its corresponding predetermined region. An atrial tether 340 can be attached to the atrial arm at a predetermined area to stabilize the implant 360 relative to the implant retainer 335 (e.g., to prevent slippage or displacement of the implant 360). For example, a first atrial passage can define a first opening, and a second atrial passage can define a second opening distal to the first opening, such that the atrial tether 340 extends from the second opening, through the atrial arm of the implant 360, and into the first opening, or vice versa. The first and second openings can correspond to positions along the atrial arm of the implant 360.

[0068] In some embodiments, a ventricular tether 350 may be disposed through a second portion of the implant 360 (e.g., an opening defined by the ventricular arm of the implant) to attach the ventricular arm of the implant 360 to the ventricular tether 350. The ventricular tether 350 may be attached to the implant 360 in a similar manner to the atrial tether 340. In some embodiments, a ventricular passage 338 may be configured such that the ventricular tether 350 extends partially beyond the implant retainer 335. The implant retainer 335 may include two sets of ventricular passages 338. A first set of ventricular passages 338 is in the proximal portion of the implant retainer 335, and a second set of ventricular passages 338 is in the distal portion of the implant retainer. The first set of ventricular passages may define a first set of openings in the proximal portion of the implant retainer 335, and the second set of ventricular passages may define a second set of openings in the distal portion of the implant retainer 335. The second set of openings may include two openings on the back of the implant retainer 335 and two openings on the front of the implant retainer 335. The ventricular tether 350 may be configured to: (i) extend from the first set of ventricular channels 338 through the ventricular channels; (ii) exit the back of the implant retainer 335 and extend to the exterior of the implant retainer 335; (iii) extend posteriorly at a distal end to the back of the implant retainer 335; (iv) exit the front of the implant retainer 335 at a distal end; and (v) circulate through the ventricular arm of the implant 360. The implant 360 may change from a closed configuration to an open configuration in response to tension applied to the ventricular tether 350 (e.g., by proximal actuation of the end of the ventricular tether), thereby pulling the ventricular arm away from the atrial arm of the implant 360. The implant 360 can be converted from an open configuration to a closed configuration by releasing tension from the ventricular tether 350 (e.g., introducing relaxation thereto) (e.g., actuating the end of the ventricular tether distally). In some embodiments, the implant 360 can be released from the cavity 337 by releasing tension from the atrial tether 340 (e.g., introducing relaxation thereto) (e.g., actuating at least one end of the atrial tether distally). In some embodiments, after releasing tension from the atrial tether 340, tension can also be released from the ventricular tether 350 to release the implant 360 from the cavity 337 (e.g., further release). The implant catheter can be withdrawn proximally so that the effectiveness of the implant 360 clamped on the leaflet of the heart valve in reducing valvular regurgitation can be visualized (e.g., via imaging). In some embodiments, tensioning the atrial tether 340 can tighten or pull the implant 360 against the implant retainer 335, releasing the tension on the atrial tether 340 allows the distal end of the delivery system to move away from the implant 360, and re-tightening the atrial tether 340 can re-tighten or pull the implant 360 against the implant retainer 335.

[0069] In some embodiments, a first atrial canal may define an opening (e.g., a first opening) on ​​the implant retainer 335, the opening being configured to align with the proximal edge of a first arm or segment of the implant 360 when the implant 360 is attached to the implant retainer. In some embodiments, a second atrial canal may define an opening (e.g., a second opening) on ​​the implant retainer 335, the opening being configured to align with a location of the distal edge of the first arm or segment (e.g., the location where the central member begins) when the implant 360 is attached to the implant retainer 335. In this way, the first arm or segment of the implant 360 may be secured to the implant retainer 335 at two points along its length. In some embodiments, a first atrial tether may extend through the first atrial canal, and a second atrial tether may extend through the second atrial canal. In some embodiments, the first atrial tether may be attached to the first segment or arm of the implant 360 at a first location, and the second atrial tether may be attached to the first segment or arm of the implant 360 at a second location distal to the first location. In some embodiments, an atrial tether may extend through both the first and second atrial passages, and a first portion of the atrial tether may be attached to the implant 360 at a first location, and a second portion of the atrial tether may be attached to the implant 360 at a second location.

[0070] In some embodiments, the total length of the implant retainer 335 (e.g., the distance between the proximal end and the distal tip of the implant retainer 335) may range from about 15 mm to about 45 mm, including all ranges and subranges therein. In some embodiments, the total length of the implant retainer 335 may be about 21 mm. In some embodiments, the distal portion of the implant retainer 335 (from the distal end of the implant 360 in the closed configuration to the distal tip of the implant retainer 335) may have a length corresponding to the torque arm for hinged implant 360. In some embodiments, the distal portion of the implant retainer 335 may be straight. In some embodiments, the distal portion of the implant retainer 335 may be curved. In some embodiments, the distal portion of the implant retainer 335 may be dome-shaped. The curved or dome-shaped distal portion may act as a fulcrum when the ventricular tether 350 is tightened to open the arm. For example, at least a portion of the second set of ventricular channels 338 in the distal end of the implant retainer 335 may act as a fulcrum for the ventricular tether. In some embodiments, the increased length of the distal portion can increase the torque arm to allow the implant 360 to more easily transition between open and closed configurations (e.g., with less tension acting on the tether). In some embodiments, the length of the distal portion of the implant retainer 335 can be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or about 10 mm, including all ranges and subranges therein. In some embodiments, the length of the implant retainer 335 can be at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, or at least 7 mm longer than the length of the implant 360 to ensure a desired torque arm to facilitate articulation and / or to open the ventricular arm of the implant 360 to an angle greater than 90 degrees without the distal portion of the implant retainer 335 impeding such movement of the ventricular arm. In some embodiments, the implant retainer 335 can be at least 5 mm longer than the length of the implant 360. The distal tip should be longer than the implant to increase the torque arm for easy articulation. However, the distal tip should not be so long that it cannot traverse the tortuous path of the delivery system. Therefore, the distal tip should have a shorter length than the tortuous length of the guiding catheter (as per relevant information). Figures 1A to 1B (as described).

[0071] In some embodiments, the shape of the cavity 337 may correspond to the size of the implant 360. For example, the cavity 337 may define a radius of curvature that is at least the radius of curvature of the implant 360 including the cover. In some embodiments, the implant 360 may be located within the cavity 337 to reduce snagging of the implant 360 on nearby tissues during the navigation of the implant retainer 335 through the vascular system and the heart. In some embodiments, the profile of the implant retainer 335 may range from about 5 mm to about 6.5 mm, including all ranges and subranges therein. In some embodiments, the implant retainer 335 may be substantially cylindrical. In some embodiments, the diameter of the implant retainer 335 may range from about 4 mm to about 10 mm, including all ranges and subranges therein.

[0072] In some embodiments, the implant retainer 335 may include a proximal engagement surface (e.g., a flat portion) on which a first segment or arm (e.g., an atrial arm) of the implant 360 may be secured. For example, when the atrial tether 340 is tightened, at least a portion of the atrial arm of the implant 360 may be configured to abut at least a portion of the proximal engagement surface of the implant retainer 335 to help secure the implant 360 relative to the implant retainer 335. In some embodiments, the proximal engagement surface may lie in a plane parallel to a plane passing through the longitudinal axis of the implant retainer 335. In some embodiments, the proximal engagement surface may be inclined (e.g., not parallel to a plane passing through the longitudinal axis of the implant retainer 335). In some embodiments, the length of the proximal engagement surface may correspond to the length of the first segment or arm of the implant 360. For example, the length of the engagement surface may range from about 4 mm to about 10 mm, including all ranges and subranges therein. In some embodiments, the inclined proximal portion may reduce the overall profile of the implant retainer 335. In some embodiments, the implant retainer 335 may be formed of a rigid biocompatible material (e.g., a material similar to that of catheters 110, 120, 130).

[0073] Figure 4This is a schematic diagram of an implant 460 configured to be implanted on the leaflet of a heart valve to reduce valvular regurgitation, according to an embodiment. In some embodiments, the implant 460 may have an engagement portion including a three-dimensional shape and an attachment portion configured to attach the device to a heart valve (e.g., mitral, tricuspid, pulmonary, or aortic valve) at its treatment site. The treatment site may correspond to the portion of the heart valve that causes cardiac symptoms such as valvular regurgitation during systole. For example, the treatment site can be located along the anterior leaflet of the mitral valve (e.g., A1, A2, A3), the posterior leaflet of the mitral valve (e.g., P1, P2, P3), the chordae tendineae of the mitral valve, the anterior leaflet (i.e., cusp) of the tricuspid valve, the posterior leaflet (i.e., cusp) of the tricuspid valve, the septal leaflet (i.e., cusp) of the tricuspid valve, the chordae tendineae of the tricuspid valve, the left coronary leaflet (i.e., cusp) of the aortic valve, the right coronary leaflet (i.e., cusp) of the aortic valve, the non-coronary leaflet (i.e., cusp) of the aortic valve, the left leaflet (i.e., cusp) of the pulmonary valve, the right leaflet (i.e., cusp) of the pulmonary valve, or the anterior leaflet (i.e., cusp) of the pulmonary valve.

[0074] The implant 460 can be attached to the heart valve tissue (e.g., the first primary leaflet) at the treatment site in a manner that reduces or eliminates regurgitation. For example, the implant 460 can be attached to the heart valve tissue such that the gap between the two primary leaflets of the heart valve is reduced or eliminated. In one variation, the implant 460 can be attached to the heart valve tissue such that the engagement portion of the implant 460 can be engaged by the second primary leaflet. For example, in some variations where the engagement portion of the implant 460 provides an engagement surface for the second primary leaflet, the treatment site may be referred to as P3-A3 because the device can be attached to the P3 portion of the posterior leaflet of the mitral valve and can be engaged by the A3 region of the anterior leaflet of the mitral valve. In a further example, the implant 460 can be attached to the A3 portion of the posterior leaflet of the mitral valve and can be engaged by the P3 region of the anterior leaflet of the mitral valve. In some variations, the implant 460 may be coupled to a leaflet having a gap or slit, such that the abutment portion of the device can cover the gap or slit of the leaflet, while allowing opposing leaflets to engage with the abutment portion. In some variations, multiple implants 460 may be coupled to leaflets having gaps, such that they are adjacent to each other on the same leaflet, opposite each other on different leaflets, or a combination thereof.

[0075] Treatment sites may correspond to portions of the heart valve associated with damage, disease, geometric deformities, and / or leaflet dysmobility, and may be determined by a physician using clinical data such as blood pressure, heart rate, acoustic signals, images generated by non-invasive techniques (e.g., MRI, CT, ultrasound, fluoroscopy), images generated by invasive techniques (e.g., intracardiac echocardiography, transesophageal echocardiography), or combinations thereof. For example, a physician may use measurements of leaflet mobility, such as offset angles, to determine the treatment site. Offset angles may correspond to the amplitude of leaflet movement between diastole and systole. In some variations, offset angles may be between approximately 5 degrees and approximately 75 degrees, approximately 5 degrees and approximately 60 degrees, approximately 5 degrees and approximately 45 degrees, or approximately 5 degrees and approximately 25 degrees. For example, in some variations, offset angles may be approximately 5 degrees, approximately 15 degrees, approximately 25 degrees, or approximately 45 degrees, or less than approximately 25 degrees. In this way, the implant 460 can advance to the heart valve and connect to the treatment site to reduce or eliminate heart valve regurgitation (e.g., reduce or close the gap between the leaflets), even though the leaflet offset angle is reduced.

[0076] Implant 460 may include one or more portions configured to attach to one or more parts of a heart valve, such that the implant can reduce or eliminate valvular regurgitation. In some embodiments, the attachment portion may be configured to releasably engage heart valve tissue and advantageously allow the implant to be securely attached to the heart valve tissue and, if necessary, disengaged from the heart valve tissue for removal or repositioning at another treatment site of the heart valve. In some variations, the length of the leaflet attached (e.g., clamped) by implant 460 may be adjusted so that the attachment portion can clamp more or fewer leaflets. In this way, the physician can optimize the effectiveness of the implant by repositioning (e.g., once or multiple times) at treatment sites associated with maximally reducing valvular regurgitation (e.g., reducing the gap between the posterior and anterior leaflets of the mitral valve).

[0077] The attachment portion of the implant 460 may include two segments (e.g., planar segments) or arms configured to attach to a portion of a heart valve, thereby attaching the implant 460 to one or more of the native leaflet and chordae tendineae. For example, the attachment portion may include at least a portion of a first segment or arm 462 and a second segment or arm 464. The first segment or arm 462 and the second segment or arm 464 may be offset toward each other such that the first segment or arm 462 and the second segment or arm 464 are held (e.g., compressed) in heart valve tissue (e.g., the posterior or anterior leaflet of the mitral valve) received therebetween. In some variations, the first segment or arm 462 and the second segment or arm 464 may be offset toward each other such that the first segment or arm 462 and the second segment or arm 464 are at least partially and in some variations completely coplanar in a delivery configuration or a closed configuration (e.g., a resting position). The first segment or arm 462 and the second segment or arm 464 may be configured to securely attach to the heart valve so that the implant 460 will not become loose after implantation. The attachment portion may define the distal portion of the device (relative to the physician during implantation).

[0078] The attachment portion may further include one or more friction elements 470 configured to apply frictional force to the heart valve tissue. One or more friction elements 470 may extend from at least one of the first segment or arm 462 and the second segment or arm 464 to help prevent unintentional movement and / or removal of the implant 460 during and / or after implantation. The frictional force generated by the friction elements 470 may be mitigated by a physician during the implantation procedure (e.g., during removal and / or repositioning, if necessary) by, for example, separating the first segment or arm 462 and the second segment or arm 464 and / or first pulling the first segment or arm 462 and the second segment or arm 464 upwards and then pulling away from the heart valve tissue to disengage the friction elements 470 from the heart valve tissue. In this way, the implant 460 can remain firmly attached to the heart valve tissue during normal cardiac events (e.g., heartbeat in a normal state, which may include strenuous exercise associated with a high heart rate), while providing physicians with the flexibility to position and reposition the implant 460 once or multiple times (e.g., twice, three times, four times or more) during implantation.

[0079] The engagement portion of the implant 460 may be configured (alone or in combination with the attachment portion) to enhance and / or alter the physical properties of the native leaflet (e.g., the first native leaflet). In some variations, the engagement portion may be configured to provide an engagement surface for another native leaflet of the heart valve (e.g., the second native leaflet). For example, the engagement portion may be configured to provide a contact surface for non-destructively receiving the second native leaflet during systole, which may reduce or eliminate valvular regurgitation (e.g., reduce or close the gap between the leaflets). At least a portion of the engagement portion may deflect upon engagement by the native leaflet. In some embodiments, the engagement portion may be configured to receive a portion of the first native leaflet (i.e., the leaflet to which the attachment portion is attached). In other words, the engagement portion may define a volume, and a portion of the first native leaflet may be positioned within that volume when the device is attached to the first native leaflet.

[0080] The engagement portion may include a central member 466, from which a first segment or arm 462 and a second segment or arm 464 may each extend. The first segment or arm 462 may extend from a first portion of the central member 466, and the second segment or arm 464 may extend from a second, different portion of the central member 466. In some embodiments, the first segment or arm 462 and the second segment or arm 464 may extend from opposite ends of the central member 466. The central member 466 may be shaped (e.g., bent) to bias the first segment or arm 462 and the second segment or arm 464 toward each other or to facilitate their biasing toward each other. When engaged with heart valve tissue, the biasing force provided by the central member 466 may be sufficient to hold the first segment or arm 462 and the second segment or arm 464 in place. The biasing force can be overcome by applying a force, such as by an elongated member of the implant delivery system or a tether (e.g., an atrial tether 140 and / or a ventricular tether 150), to at least one of the segments or arms 462, 464, allowing the first segment or arm 462 and the second segment or arm 464 to be separated from each other. In this way, the implant 460 can be opened to receive heart valve tissue and / or it can be removed from the heart valve tissue (e.g., for repositioning). Additionally, changes in the curvature and / or shape of the central member 466 can allow the first segment or arm 462 and the second segment or arm 464 to be separated from each other.

[0081] The engagement portion may further include one or more support members 480 configured to provide surfaces for engagement by the native leaflet, such as via the support cover 468. One or more support members 480 of the support cover 468 may be referred to as a first portion of the engagement portion. The engagement portion may further include a second portion extending from the proximal end of the first portion. The second portion may be without support members 480. In some embodiments, the support member 480 may extend from the central member 466. In some embodiments, the support member 480 may extend from the first segment or arm 462 and may be configured to elastically deform with each interaction with the opposing leaflet, which may contribute to the durability and effectiveness of the implant 460. For example, mechanical stress concentration can be reduced by extending the support member 480 from the first segment or arm 462, which may increase the durability of the implant 460. The support member 480 may extend from the first segment or arm 462 to define a larger volume of the engagement portion, relative to a variation in which the support member 480 extends from the central member 466. For example, the radius of curvature of the support member 480 extending from the first segment or arm 462 can be greater than the radius of curvature of the support member 480 extending from the central member 466. A larger radius of curvature can allow the implant 460 to absorb forces from the native leaflet (e.g., via engagement) without being damaged, dislodged from the first native leaflet, and / or damaging any part of the native leaflet.

[0082] The support member 480 may include a free end, allowing it to move (e.g., deflect, extend, or contract) relative to other portions of the implant 460. For example, the support member 480 may deflect when the leaflets exert force on the engagement portion (e.g., during systole), and when the leaflets do not exert force on the engagement portion (e.g., during diastole), the support member may elastically return to its previous configuration. Movement facilitated by the free end can advantageously minimize mechanical stress at the connection point between the support member 480 and the first segment or arm 462. Minimizing such mechanical stress can allow the support member to deflect, bend, or otherwise move without rupture when engaged by another portion of the heart valve, which can facilitate complete closure of the heart valve and / or reduce the size of the fluid flow path (e.g., by reducing the gap between the two native leaflets). Implants partially attached to chordae tendineae may exhibit similar behavior.

[0083] The joining portion may define a volume configured to receive a portion of the original leaflet and / or surround a portion of the original leaflet (e.g., the original leaflet joined by the attachment portion) upon engagement. In some variations, the volume of the joining portion may be determined by the total width and total height of the outer portions of the two or more support members 480 and the length of the joining portion associated with a portion of the second segment or arm 464 and / or a portion of the central member 466. Thus, the total width, total height, and joining portion length can be used to determine the volume of the joining portion. The joining portion may be formed in a bulbous shape. In some embodiments, the maximum length of the joining portion (e.g., the maximum length along the longitudinal axis of the joining portion) may be shorter than the maximum width of the joining portion (e.g., the maximum length along the transverse axis of the joining portion). The height of the joining portion may be defined as the distance from the first surface of the cover 468 that contacts the leaflet to the second surface of the cover 468 that faces away from the leaflet. The maximum length and maximum width of the joining portion and / or the ratio of the maximum length to the maximum width may be modified by altering the shape of the support member 480. The joining portion may taper gradually along the longitudinal axis and / or along the transverse axis (e.g., the cross-sectional area may decrease). For example, the length, width, and / or height of the joining portion may decrease toward the outer edge of the implant 460, such that the joining portion forms an ellipse, a soccer ball, an almond shape, etc. Along the longitudinal axis, the joining portion may be flush with the leaflet surface, reaching a peak (e.g., an increase in height from the leaflet surface), and then gradually taper toward the leaflet surface. In some embodiments, the volume captured between the original leaflet surface and the surface defined by the cover 468 disposed above the support member 480 may be symmetrical (or substantially symmetrical) along the longitudinal axis.

[0084] Implant 460 may be at least partially covered by cover 468. In some embodiments, any portion of implant 460 may include one or more materials configured to elastically deflect. For example, implant 460 including a first segment or arm 462 and / or a second segment or arm 464 may include any suitable material, such as metals (e.g., nitinol, titanium, aluminum, gold, silver, and their alloys) or polymers (e.g., polypropylene, polyvinyl chloride, polyethylene, polyurethane). In some embodiments, implant 460 may include nitinol having an austenitic end temperature below room temperature. This means that implant 460 may maintain its intended shape at room temperature and / or body temperature, and that implant 460 may return to its intended shape after deformation when the deformation force is released. Implant 460 may be configured to withstand strains of up to about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, and about 20%. In some embodiments, the implant 460 may be configured to withstand strain of up to about 10%.

[0085] In some embodiments, the cover 468 may comprise any suitable material, such as, for example, fabric (e.g., textile) or polymer (e.g., polyester, polytetrafluoroethylene (PTFE)). In some embodiments, the cover 468 may comprise, for example, polyester fabric, knitted polyester, woven polyester, PTFE, or a combination thereof. In some embodiments, the cover 468 may comprise two different materials. The fabric may be further reinforced with wire along its boundaries or a portion thereof to provide it with a shape different from that provided by the implant. The attachment and engagement portions of the implant may be covered with different materials and using different methods. The attachment portion may be covered to enhance visibility of the clinical imaging modality during implantation and is optimized to have a thickness that allows the tooth / friction element to protrude from the fabric portion. The engagement portion may be covered to provide a smooth surface for engaging the opposing native leaflets to avoid wear and tear during repeated engagement with the opposing leaflets, and / or to be blood-compatible and allow tissue growth and endothelialization. In some embodiments, the materials of the first arm 462 and / or the second arm 464 and / or the cover 468 may be selected to optimize (e.g., minimize) the weight of the implant 460. This can prevent the implant 460 from pulling on portions of the heart valve due to gravity, which in turn can reduce the effectiveness of the implant in reducing valvular regurgitation. Therefore, in some embodiments, the implant 460 may have a weight of about 50 mg to about 500 mg, about 100 mg to about 150 mg, or about 130 mg to about 140 mg, including about 100 mg, about 110 mg, about 120 mg, about 130 mg, about 140 mg, or about 150 mg. In some embodiments, the body of the implant 460 (e.g., arms 462, 464, and central member 466) may be formed from a single sheet of metal or metal alloy. Therefore, small parts or complex components are not required to assemble the implant 460. In some embodiments, the body of the implant may be formed of a first metal or metal alloy sheet, and the friction element 470 may be separately formed and welded to the body with a second metal or metal alloy sheet that is thinner than the first sheet. In some embodiments, the friction element 470 may be welded to the body via a weld along a specific region of the implant 460. Therefore, the thickness of the body may be greater than the thickness of the friction element 470. For example, the first sheet (and thus the body of the implant 460) may have a thickness of about 250 µm, and the second sheet (and thus the friction element 470) may have a thickness of about 100 µm. In some embodiments, the total length of the implant (e.g., along the longitudinal axis of the implant 460) may be about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, including all ranges and subranges therein.In some embodiments, the implant 460 may be manufactured in sizes of 10 mm, 12 mm, and 16 mm.

[0086] In some embodiments, the cover 468 (e.g., the material of the cover 468) can facilitate tissue embedding of the implant 460. For example, the cover 468 can enable the implant 460 to permanently integrate into the native leaflet within 30 to 60 days after implantation. Therefore, the patient can gradually discontinue anticoagulants and live a life free of bleeding symptoms.

[0087] a. segment or arm

[0088] As described herein, implant 460 includes a first segment or arm 462 and a second segment or arm 464, which are configured to facilitate attachment to heart valve tissue by applying forces (e.g., compressing tissue therebetween) to the heart valve tissue. Therefore, the shapes of the first segment or arm 462 and / or the second segment or arm 464 can be configured to provide distributed compressive forces to the heart valve tissue while minimizing the forces described herein. Figures 29A to 29F , Figures 30A to 30D and Figures 31 to 33 Stress concentration during the described deployment, implantation, and / or removal methods. The first segment or arm 462 and the second segment or arm 464 may be configured to connect different sides of the same primary leaflet. For example, the first segment or arm 462 may be configured to connect a first side (e.g., the atrial side) of the first primary leaflet, and the second segment or arm 464 may be configured to connect a second side (e.g., the ventricular side) of the first primary leaflet.

[0089] In some embodiments, the first segment or arm 462 and the second segment or arm 464 may each include one or more portions configured to non-destructively connect to heart valve tissue. For example, the first segment or arm 462 and the second segment or arm 464 may each include a planar portion and a curved portion. More specifically, the first segment or arm 462 may include a first planar portion and a first curved portion, and the second segment or arm 464 may include a second planar portion and a second curved portion. The planar portions of the first segment or arm 462 and / or the second segment or arm 464 may be configured to contact heart valve tissue without causing damage to the heart valve tissue. In some variations, the first planar portion and the second planar portion may be substantially coplanar when the implant 460 is in a delivery configuration or a closed configuration. For example, the first segment or arm 462 may have a larger maximum width than the second segment or arm 464 and may define an opening sufficient to accommodate the second segment or arm 464, such that the first segment or arm 462 and the second segment or arm 464 may be coplanar. In some embodiments, the second segment or arm 464 may be configured to at least partially extend through the opening defined by the first segment or arm 462, such that the leaflet is compressed in multiple regions to provide better leaflet grip. For example, the first segment or arm 462 may push the leaflet toward the second segment or arm 464 such that when the leaflet is positioned in the first segment or arm 462 and the second segment or arm 464, the leaflet forms a wavy shape, which prevents displacement or slippage of the implant 460.

[0090] The first curved portion and the second curved portion may extend from the first planar portion and the second planar portion of the first segment or arm 462 and the second segment or arm 464, respectively. The first curved portion and the second curved portion may each be configured to provide a biasing force to the first planar portion and the second planar portion, respectively. More specifically, when the first planar portion is in contact with heart valve tissue, the first curved portion may provide a biasing force to the first planar portion such that the first planar portion does not unintentionally separate from the heart valve tissue. Similarly, when the second planar portion is in contact with heart valve tissue, the second curved portion may provide a biasing force to the second planar portion such that the second planar portion does not unintentionally separate from the heart valve tissue. Although the above description includes both planar and curved portions, it should be understood that the first segment or arm and / or the second segment or arm may each be entirely planar or entirely curved.

[0091] The dimensions (e.g., length, width) of the first segment or arm 462 and the second segment or arm 464 can be determined based on a variety of factors, including but not limited to the patient's height, age, sex, valve to be treated, valve anatomy, and the severity of heart disease. Therefore, the implant 460 can be manufactured in a variety of sizes, allowing physicians to pre-select the implant 460 based on patient-specific factors such as those mentioned above. Pre-selection of the implant 460 can increase the effectiveness of the implant 460 by making its size more closely match the characteristics of a specific patient. In some variations, the first segment or arm 462 may include a first length of about 1 mm to about 10 mm, about 2 mm to about 9 mm, about 3 mm to about 8 mm, or about 4 mm to about 7 mm, including about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm. The second segment or arm may include a second length of about 1 mm to about 10 mm, about 2 mm to about 9 mm, about 3 mm to about 8 mm, or about 4 mm to about 7 mm, including about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm.

[0092] In some embodiments, the implant 460 occupies about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% of the total leaflet surface area of ​​the heart valve. In some embodiments, the implant 460 may occupy about 5% to about 10% of the total leaflet surface area. In some embodiments, when attached to the leaflet, the implant 460 occupies 8% of the total leaflet surface area and is not expected to restrict diastolic flow across the valve.

[0093] In some variations, the first segment or arm 462 may include a length different from that of the second segment or arm 464. The different lengths may correspond to the surface area of ​​the native leaflet to which the respective segment or arm can be attached. Therefore, the length of the first segment or arm 462 may be about 1% to about 75%, about 5% to about 60%, about 5% to about 50%, or about 5% to about 25% longer than the length of the second segment or arm 464. For example, in some variations, the length of the first segment or arm 462 may be about 1%, about 5%, about 25%, or about 50% longer than the length of the second segment or arm 464. The relative lengths of the first segment or arm 462 and the second segment or arm 464 may define a ratio. In some variations, the length ratio may be about 1.01 to about 1.75, about 1.05 to about 1.6, about 1.05 to about 1.5, or about 1.05 to about 1.25. For example, in some variations, the length ratio may be about 1.01, about 1.05, about 1.25, or about 1.5.

[0094] In addition to the lengths of the first segment or arm 462 and the second segment or arm 464, the width of each segment or arm 462, 464 may be configured to distribute compressive forces. In some variations, the width of the first segment or arm 462 and / or the second segment or arm 464 may vary along its length. In some variations, changing the width of the first segment or arm 462 and / or the second segment or arm 464 may reduce mechanical stress and / or avoid stress concentration “hot spots” during or after implantation. For example, each of the first arm 462 and / or the second arm 464 may transition from a first width to a second width at any point along the longitudinal dimension of the first arm 462 and / or the second arm 464, such as approximately ¼, approximately 1 / 3, approximately ½, approximately 2 / 3, or approximately ¾ of the distal edge of the first arm 462 and / or the second segment or arm 464. In some embodiments, the maximum width of the first segment or arm 462 may be from about 1 mm to about 10 mm, from about 2 mm to about 8 mm, from about 3 mm to about 7 mm, and from about 4 mm to about 6 mm, including about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, and about 8 mm. In some variations, the maximum width of the second segment or arm 464 may be from about 1 mm to about 8 mm, from about 2 mm to about 8 mm, or from about 3 mm to about 5 mm, including about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. In some embodiments, the first segment or arm 462 may have a larger maximum width than the second segment or arm 464, such that the first segment or arm 462 can define an opening sufficient to receive the second segment or arm 464. Thus, in some variations, the maximum width of the first segment or arm 462 may be from about 1.01 times to about 2 times, from about 1.05 times to about 1.75 times, or from about 1.05 times to about 1.5 times the maximum width of the second segment or arm 464. For example, in some variations, the maximum width of the first segment or arm 462 may be about 1.05 times, about 1.25 times, about 1.5 times, or about 1.75 times the maximum width of the second segment or arm 464.

[0095] The first segment or arm and the second segment or arm may each comprise any shape suitable for attachment to the heart valve tissue and for maintaining the position of the implant relative to the anatomical structure. For example, the shape of the first segment or arm 462 and / or the second segment or arm 464 may be square, rectangular, circular, elliptical, oval, triangular, or a combination thereof. In some variations, it may be advantageous to avoid using sharp corners that could unintentionally damage the tissue; therefore, in some embodiments, one or more ends or edges of the first segment or arm 462 and / or the second segment or arm 464 may be rounded. For example, in some variations, the first segment or arm 462 and / or the second segment or arm 464 may have a square or rectangular shape with rounded corners. The first segment or arm 462 and the second segment or arm 464 may also have any suitable cross-sectional shape, including, for example, square, circular, trapezoidal, triangular, or a combination thereof.

[0096] b. Friction elements

[0097] In some variations, the first segment or arm 462 and / or the second segment or arm 464 may be configured to apply frictional forces. These frictional forces may be configured to hold the implant 460 at the intended treatment site without slipping or otherwise moving. For example, each of the first segment or arm 462 and the second segment or arm 464 may include one or more (e.g., multiple) friction elements 470 configured to apply frictional forces to non-destructively engage heart valve tissue. Friction elements 470 may include, but are not limited to, fangs, teeth, points, hooks, bumps (e.g., rounded bumps), surface roughening structures, etc. Friction elements 470 may be located on or otherwise carried by any portion of the tissue-facing surface of the first segment or arm 462 and / or the second segment or arm 464. More specifically, friction elements 470 may be positioned along one or more edges of one or more of the first segment or arm 462 and the second segment or arm 464, along the central axis of the tissue-facing surfaces 462, 464, and / or between one or more edges and the central axis.

[0098] In some embodiments, the friction elements 470 may be arranged along the longitudinal dimension of one or more of the first segment or arm 462 and / or the second segment or arm 464. The longitudinal arrangement may be collinear, or in some variations, may include one or more offsets. The friction elements 470 may be uniformly spaced along tissue-facing surfaces (e.g., along the edges of the tissue-facing surfaces of the first segment or arm 462 and / or the second segment or arm 464), or may be non-uniformly spaced. In some embodiments, the friction elements 470 may be integrally formed with the first segment or arm 462 and / or the second segment or arm 464. Alternatively and / or additionally, the friction elements 470 may be formed separately from the first segment or arm 462 and / or the second segment or arm 464 and may be attached thereto (e.g., via a plate or other structural element on which the friction elements 470 are formed). The friction elements 470 may have a cross-sectional shape such as triangular, circular, or rectangular. In some embodiments, all friction elements 470 may have the same size and shape. In some embodiments, one or more friction elements 470 may have a first size and / or shape, and one or more other friction elements 470 may have a different size and / or shape. Similarly, the first segment or arm 462 and / or the second segment or arm 464 may include the same or different types of friction elements 470. For example, one or more friction elements 470 on the first segment or arm 462 and / or the second segment or arm 464 may be of a first type (e.g., serrations), and one or more friction elements on the first segment or arm 462 and / or the second segment or arm 464 may be of a second type (e.g., hooks). In some variations, all friction elements 470 on the first segment or arm 462 may have a first size, shape, and / or type, and all friction elements 470 on the second segment or arm 464 may have a second different size, shape, and / or type. In some embodiments, the angle at which the friction elements 470 extend from the first segment or arm 462 and / or the segment or arm 464 may vary based on the position of the implant 460. For example, friction elements 470 have equivalent shapes and sizes, but can be bent at different angles based on their corresponding positions on the implant 460, which in Figures 16A to 16C The following is a more detailed description.

[0099] In some embodiments, the friction element 470 may include one or more surface roughening features. For example, each of the first segment or arm 462 and the second segment or arm 464 may include a plurality of protrusions configured to increase the coefficient of friction between the tissue-facing surface of the respective segment or arm 462, 464 and the heart valve tissue. In some embodiments, each protrusion may be circular. In some embodiments, each protrusion may be pointed (e.g., serrated). The plurality of protrusions may be arranged in one or more rows, which may form a grid. In some variations, the plurality of protrusions may be randomly arranged or may be arranged in one or more rows, extending along the longitudinal and / or transverse dimensions of the respective segment or arm 462, 464. The plurality of protrusions may be combined with any other configuration of the friction element 470 described herein.

[0100] Friction elements 470 may extend from and form an angle with the tissue-facing surfaces of the first segment or arm 462 and / or the second segment or arm 464. For example, in some embodiments, the angle between one or more friction elements 470 and the tissue-facing surfaces of the first segment or arm 462 and / or the second segment or arm 464 adjacent to the base of the friction element 470 or otherwise may be about 5 degrees to about 90 degrees, about 10 degrees to about 75 degrees, about 15 degrees to about 60 degrees, or about 40 degrees to about 50 degrees, including all ranges and subranges therein. For example, in some variations, the angle may be about 5 degrees, about 15 degrees, about 30 degrees, about 45 degrees, or about 60 degrees, including all ranges and subranges therein. In some embodiments, all friction elements 470 may extend from the tissue-facing surfaces of their respective arms 462, 464, on which they are positioned at the same angle. In other embodiments, some friction elements 470 on the first segment or arm 462 and / or the second segment or arm 464 may extend at different angles than other friction elements 470 on the same segment or arm or on the opposite segment or arm.

[0101] The implant 460 may include any suitable number of friction elements 470 to maintain the position of the implant 460 relative to the patient's anatomy when the implant 460 is implanted. For example, each of the first segment or arm 462 and the second segment or arm 464 may include 1 to 20, 2 to 15, or 3 to 10 friction elements 470, including all ranges and sub-ranges therein. In some embodiments, the first segment or arm 462 and / or the second segment or arm 464 may include about 6 to 12 friction elements.

[0102] In some embodiments, a first set (e.g., two or more, such as three, four, five, six, seven, eight, nine, ten or more) of friction elements 470 may be positioned along one or more edges of the tissue-facing surface of a first portion of a first segment or arm 462, and a second set of friction elements 470 may be positioned along one or more edges of the tissue-facing surface of a second portion of a first segment or arm 462. The first set of friction elements 470 may define a first angle relative to the tissue-facing surface of the first portion of the first segment or arm 462, and the second set of friction elements 470 may define a second angle relative to the tissue-facing surface of the second portion of the first segment or arm 462. Similarly, a third set of friction elements 470 may extend along one or more edges of the tissue-facing surface of a second segment or arm 464 and may define a third angle relative to the tissue-facing surface of the second segment or arm 464. When the implant 460 is in a closed configuration (e.g., when the first segment or arm 462 and the second segment or arm 464 can be coplanar), the first set of friction elements and / or the second set of friction elements 470 can extend beyond the second segment or arm 464 and / or the third set of friction elements 470 can extend beyond the first segment or arm 462. That is, the first set of friction elements and / or the second set of friction elements 470 on the first segment or arm 462 may not be coplanar with the second segment or arm 464, and the third set of friction elements 470 on the second segment or arm 464 may not be coplanar with the first segment or arm 462.

[0103] The frictional force can be determined by a first angle, a second angle, and / or a third angle defined by each set of corresponding friction elements 470. For example, increasing one or more of the first angle, the second angle, and the third angle can increase the frictional force, and decreasing one or more of the first angle, the second angle, and the third angle can decrease the frictional force. In this way, the frictional force can be adjusted by manipulating the first angle, the second angle, and / or the third angle, wherein the manipulation can be performed during the manufacturing stage and / or by a physician before performing the surgical procedure described herein. The first angle can be about 0 degrees to about 90 degrees, about 10 degrees to about 60 degrees, or about 20 degrees to about 45 degrees, including about 30 degrees, including all ranges and subranges therebetween. The second angle can be about 0 degrees to about 90 degrees, about 10 degrees to about 60 degrees, or about 20 degrees to about 45 degrees, including about 15 degrees, including all ranges and subranges therebetween. The third angle can be about 0 degrees to about 90 degrees, about 10 degrees to about 60 degrees, or about 20 degrees to about 45 degrees, including about 40 degrees, including all ranges and subranges therebetween.

[0104] One or more sets of friction elements 470 may include a height sufficient to engage the heart valve tissue. In some variations, the height of one or more sets of friction elements 470 may be from about 10 micrometers to about 100 micrometers, from 25 micrometers to about 75 micrometers, or from about 30 micrometers to about 60 micrometers, including all ranges and subranges therein. For example, in some variations, the height of one or more sets of friction elements 470 may be about 10 micrometers, about 25 micrometers, about 35 micrometers, about 45 micrometers, or about 75 micrometers. The height of one set of friction elements 470 may be the same as or different from any other set of friction elements 470, which may facilitate optimization of the frictional force applied by the implant 460.

[0105] In some embodiments, the friction element 470 may be formed by forming a slot in the first segment or arm 462 and / or the second segment or arm 464, or by forming a slot in the structure forming the friction element (e.g., a plate). In some embodiments, the first segment or arm 462 and / or the second segment or arm 464 or the plate forming the friction element 470 may include a plurality of slots. Each slot may be adjacent to the corresponding friction element 470 and may define a length corresponding to the height of the friction element 470. The slots may facilitate forming (e.g., bending) the friction element 470 to a desired angle corresponding to the desired frictional force. That is, each slot may separate the edge of the friction element 470 from the tissue-facing surface of the segment or arm 462, 464. In some embodiments, one or more (including all) slots may terminate at a circular portion. Using slots with circular portions may be advantageous because the circular portions can reduce the mechanical stress associated with forming (e.g., bending) the friction element. Additionally, in some variations, the circular portions can prevent cracks from propagating from the slots.

[0106] c. Central component

[0107] As previously described, implant 460 may include a central member 466 positioned between a first segment or arm 462 and a second segment or arm 464. The central member 466 may be configured to provide a biasing force to one or more of the first segment or arm 462 and the second segment or arm 464, such that the first segment or arm 462 and the second segment or arm 464 may be biased toward each other. The biasing force may be sufficient to maintain the connection between the first segment or arm and the second segment or arm to the heart valve tissue. In some embodiments, the central member 466 may be curved. For example, the central member 466 may form an arc between the first segment or arm 462 and the second segment or arm 464. Thus, the biasing force may be at least partially based on the configuration of the central member (e.g., length, radius of curvature, and / or thickness). Therefore, the configuration of the central member 466 may facilitate movement of the second segment or arm 464 toward or away from the first segment or arm 462 and may define the degree to which the first segment or arm 462 and the second segment or arm 464 can be separated.

[0108] The length of the central member 466 may correspond to the compressive force applied by the first segment or arm 462 and the second segment or arm 464 according to a torque (e.g., force multiplied by distance). In some variations, the length of the central member 466 may be about 1 mm to about 10 mm, about 2 mm to about 9 mm, about 3 mm to about 8 mm, or about 4 mm to about 7 mm, including about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm, including all ranges and subranges therein.

[0109] The thickness of the central member 466 may be configured to allow the first segment or arm 462 and the second segment or arm 464 to move relative to each other without inelastic deformation or breakage. In some embodiments, the thickness of the central member 466 may vary along its length. For example, the thickness of a portion adjacent to the second segment or arm 464 may be greater than other portions of the central member 466. The thicker portions of the central member 466 may correspond to the thicker portions of the second segment or arm 464. The thicker portions of the central member 466 and / or the second segment or arm 464 may facilitate the deflection of the second segment or arm 464 relative to the first segment or arm 462 while reducing excessive force or breakage of the central member 466. In some embodiments, the thickness of the central member 466 may be between about 50 micrometers and about 500 micrometers, about 100 micrometers and about 300 micrometers, or about 200 micrometers and about 300 micrometers. In some embodiments, the thickness may be about 50 micrometers, about 100 micrometers, about 200 micrometers, about 250 micrometers, about 300 micrometers, or about 400 micrometers.

[0110] The width of the central member 466 may be configured such that mechanical stresses associated with adjusting the central member 466 (e.g., during transitions between configurations) can be minimized. In some embodiments, the width of the central member 466 may be smaller than the width of one or more of the first segment or arm 462 and the second segment or arm 464. The width of the central member 466 may be from about 1 mm to about 10 mm, from about 2 mm to about 7 mm, or from about 2 mm to about 5 mm. For example, in some variations, the width of the central member 466 may be about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. In some embodiments, the radius of curvature of the central member 466 may be in the range of about 2 mm to about 10 mm or greater. In some embodiments, the radius of curvature of the central member 466 may be about 4 mm.

[0111] The biasing force generated by the central member 466 may correspond to the compressive force applied to the heart valve tissue by the first segment or arm 462 and / or the second segment or arm 464. The compressive force may not be large enough to damage the heart valve tissue. In some embodiments, the compressive force is characterized by the magnitude of the force required to separate the first segment or arm 462 and the second segment or arm 464. In some embodiments, the biasing force may be about 100 mN to about 1000 mN, about 150 mN to about 600 mN, or about 200 mN to about 450 mN, including about 150 mN, about 200 mN, about 250 mN, about 300 mN, about 350 mN, about 400 mN, about 450 mN, about 500 mN, about 550 mN, or about 600 mN. The force applied by the first segment or arm 462 and the second segment or arm 464 may be configured to resist the force generated by the mitral systolic pressure gradient on the mitral valve.

[0112] d. Supporting components

[0113] Implant 460 may include one or more support members 480 configured to absorb impacts from one or more portions of a heart valve (e.g., via engagement) and, in some cases, to provide support for a cover 468 that may cover or otherwise attach to the support member 480. Thus, each support member 480 may have a radius of curvature to facilitate support of the cover 468 and / or the formation of a suitable engagement surface for the native leaflet. The radius of curvature may allow the support member 480 and / or the cover 468 to deflect, for example, upon impact (e.g., engagement) with another portion of the heart valve. In some embodiments, the support member 480 may deflect (e.g., bend and / or extend) in one or more directions, such that the support member 480 is in an elongated configuration (e.g., in a delivery configuration). Each support member 480 may have multiple portions, each portion having a different shape and / or radius of curvature. In some variations, each portion may be linear. In some embodiments, one or more portions of each support member 480 may be linear, and one or more portions may be curved. In some embodiments, each portion of the support member 480 may be curved. For example, one or more support members 480 may have one or more convex and concave portions. In some embodiments, one or more support members of the support members 480 may have a cross section with a radius of curvature greater than that of the central member 466. The radius of curvature of one support member 480 may be different from any other radius of curvature of another support member 480. Additionally or alternatively, one or more support members of the support members 480 may include a free end, as previously described. The free end of the support member 480 may allow the support member 480 to extend or contract further. In some embodiments, the free end of the support member 480 may each include a non-damaging distal tip, such that the support member 480 avoids damage to or otherwise harming the heart valve tissue. In some embodiments, the free end of each support member of the support members 480 may be coplanar with the proximal surface of the central member 466.

[0114] In some embodiments, at least one of the support members 480 (such as a first support member) may be configured to contact the first native leaflet (i.e., the leaflet to which the attachment portion is attached), while at least one other support member 480 (such as a second support member) may be configured to avoid contact with the first native leaflet. The second support member may be configured to contact the second native leaflet (e.g., via engagement). At least one cover (e.g., cover 468) may be attached to the engagement portion. Cover 468 may be a flexible (e.g., stretchable, extensible) material configured to move with the support members 480 such that cover 468 may deflect when the leaflet is subjected to force on the engagement portion. In this way, the heart valve can be modified to achieve complete closure, which can facilitate the durable correction of valvular regurgitation.

[0115] Support members 480 may include one or more dimensions configured to provide the flexibility described herein. For example, each support member 480 may include a length, which in some embodiments may determine the volume of the engagement portion. Each support member 480 may have the same length or a different length from any of the other support members 480. In some embodiments, the length of the support member 480 may be from about 1 mm to about 20 mm, from about 3 mm to about 15 mm, or from about 5 mm to about 12 mm, including about 3 mm, about 5 mm, about 7 mm, about 9 mm, about 11 mm, or about 13 mm. Each support member may have a width that may be determined to minimize stress concentration during deflection. In some embodiments, the width may be from about 10 micrometers to about 500 micrometers, from about 50 micrometers to about 250 micrometers, or from about 100 micrometers to about 200 micrometers, including about 50 micrometers, about 100 micrometers, or about 150 micrometers.

[0116] The number of support members 480 may be determined by the size of the treatment site and / or the heart valve. In some embodiments, the number of support members 480 may alternatively or additionally be determined by the size (e.g., area) of the cover 468. For example, the number of support members 480 may be increased to accommodate a larger cover 468, which may be beneficial for treating relatively severe valvular regurgitation associated with a relatively large gap between the valve leaflets. In some cases, having an even number of support members 480 may be advantageous, as this can help to distribute the mass of the implant 460 evenly when attached to the heart valve tissue. In some embodiments, the implant 460 may include between 2 and 10, 2 and 9, 2 and 8, 2 and 7, 2 and 6, 2 and 5, 2 and 4, and 2 and 3 support members 480. In some embodiments, the implant 460 may include 4 support members 480.

[0117] In embodiments having an even number of support members 480, the support members 480 may be symmetrical (e.g., mirror-image) about the central member 466. That is, there may be the same number of support members 480 on either side of the central member 466, and symmetrical pairs of support members 480 may have the same dimensions (e.g., length, width) and / or shape (e.g., radius or radius of curvature). For example, there may be a first support member and a second support member on a first side of the central member 466, and a third support member and a fourth support member on a second side of the central member 466, wherein the third support member may be symmetrical about the central member 466 with respect to the second support member, and the fourth support member may be symmetrical about the central member with respect to the first support member. In some embodiments, the support members 480 need not be symmetrical, which may facilitate the customization of the engagement portion to optimize treatment for a given patient.

[0118] In some embodiments, the support member 480 may be attached to the central member 466 and / or the first arm 462 or the second arm 464 and is free at their distal ends. Thus, when the implant 460 is compressed into the implant catheter of the implant delivery system (e.g., in a compressed configuration), the support member 480 is compressed inward but also elongates longitudinally to accommodate the compression. When the implant 460 is advanced outside the implant catheter, the support member 480 may transition to its baseline configuration or state (e.g., an expanded configuration), and the longitudinal elongation may decrease. In other words, when the support member 480 is in a compressed configuration (e.g., when the implant 460 is in a delivery configuration), the lateral protrusion length of the support member 480 decreases, while when the support member 480 is in an expanded configuration (e.g., when the implant 460 is in an open configuration and / or an implantation configuration), the lateral protrusion length increases (e.g., returning to the baseline state).

[0119] e. Opening

[0120] Implant 460 may define one or more openings configured to receive one or more segments or arms 462, 464, as described herein. For example, a first segment or arm 462 may define an intermediate opening configured to receive a second segment or arm 464. The intermediate opening may be configured to receive at least a portion of the second segment or arm 464 when a portion of the second segment or arm 464 is at least partially coplanar with at least a portion of the first segment or arm 462. Thus, in some embodiments, the intermediate opening may include a size and / or shape corresponding to a portion of the second segment or arm 464. The intermediate opening may include a length and a width. The length of the intermediate opening may be from about 1 mm to about 10 mm, from about 2 mm to about 8 mm, or from about 3 mm to about 6 mm. For example, in some variations, the length of the intermediate opening may be from about 1 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm. The width of the intermediate opening may be from about 1 mm to about 10 mm, from about 2 mm to about 8 mm, from about 2 mm to about 6 mm, or from about 2.5 mm to about 5.5 mm. For example, in some embodiments, the width of the intermediate opening may be about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, or about 6 mm. In some variations, the length and / or width of the intermediate opening may maintain a gap between the first segment or arm 462 and the second segment or arm 464, allowing the cover 468 to pass through the gap while allowing free movement of segments or arms 462, 464 relative to each other. The intermediate opening may be located at the centerline of the lateral (e.g., width) dimension of the first segment or arm. In some embodiments, the intermediate opening may be located at any point along the lateral dimension of the first segment or arm.

[0121] The implant 460 may further define one or more openings (e.g., positioning openings) 475 configured to facilitate adjustment of the position of each of the first segment or arm 462 and the second segment or arm 464 (e.g., opening and / or closing of the implant 460). The one or more openings 475 may be configured to receive one or more elongated members (e.g., atrial tether 140 and / or ventricular tether 150) to aid in adjustment of the position of one or more of the first segment or arm 462 and the second segment or arm 464. As previously described, an implant delivery system (e.g., implant delivery system 100) may be used to aid in opening and / or closing of the implant 460. One or more elongated members of the implant delivery system (e.g., guidewires, sutures, etc.) may be disposed through one or more positioning openings 475 of each of the first segment or arm 462 and the second segment or arm 464. For example, a first suture or tether (e.g., an atrial tether 140) may pass through one or more positioning openings 475 (e.g., suture holes) of the first segment or arm 462 and thread back into the implant catheter of the implant delivery system, such that both ends of the first suture or tether are controllable by the implant delivery system. Additionally, a second suture or tether may pass through one or more positioning openings 475 of the second segment or arm 464 and thread back into the implant catheter of the implant delivery system, such that both ends of the first suture or tether and the second suture or tether are controllable by the implant delivery system. In some embodiments, the first suture or tether may pass through one or more positioning openings 475 of the first segment or arm 462 and / or the second segment or arm 464 and subsequently be tightened (e.g., to itself or a portion of the catheter) to form a first loop, and the second suture or tether may pass through the first loop and thread back into the implant catheter of the implant delivery system to form a second loop, wherein the first loop may be smaller than the second loop.

[0122] Therefore, one or more positioning openings may include dimensions and / or shapes corresponding to one or more elongated members (e.g., atrial tethers 140 and / or ventricular tethers 150). For example, the shape of positioning opening 475 may be circular, elliptical, rectangular, or a combination thereof. This shape may be determined to reduce friction between segments or arms 462, 464 and the elongated member. The dimensions of positioning opening 475 may correspond to the diameter of the elongated member. In some variations, the dimensions may correspond to multiple elongated members passing through the same positioning opening 475. The width and length dimensions of each positioning opening 475 may be the same or different, and may depend on the number of elongated members passing through it.

[0123] The plurality of positioning openings 475 of the first segment or arm 462 and / or the second segment or arm 464 may be arranged to facilitate the application of a predetermined force distribution to the first segment or arm 462 and / or the second segment or arm 464 via the elongated member. For example, the plurality of positioning openings 475 may be arranged collinearly across the width of the first segment or arm 462 and / or the second segment or arm 464, such that the elongated member can apply force uniformly across the first segment or arm 462 and / or the second segment or arm 464. In some embodiments, the plurality of positioning openings 475 may be non-collinearly arranged such that one or more positioning openings 475 are offset from at least one other positioning opening 475. Offset can reduce friction between the elongated member and the positioning opening 475, such as when the elongated member can pass through more than one positioning opening 475. In some embodiments, the plurality of positioning openings 475 may be arranged along the longitudinal dimension of one or more of the first segment or arm 462 and / or the second segment or arm 464. The longitudinal arrangement may be collinear, or in some embodiments, may include one or more offsets. The arrangement can be configured to uniformly distribute the forces exerted by one or more elongated members passing through the plurality of positioning openings 475 and / or reduce the frictional forces between the elongated members and the positioning openings 475. In some embodiments, the longitudinal arrangement can be centered relative to the width of one or more of the first segment or arm 462 and / or the second segment or arm 464, which can further promote the uniform distribution of the forces exerted by the one or more elongated members.

[0124] In some embodiments, each of the first segment or arm 462 and the second segment or arm 464 may include a number of positioning openings 475 determined by the size and / or shape of the respective segment or arm 462, 464. For example, each of the first segment or arm 462 and the second segment or arm 464 may include one, two, three, four, five, six, seven, eight, nine, or ten positioning openings 475 configured to receive an elongated member. In some embodiments, the first segment or arm 462 and / or the second segment or arm 464 may include openings used during manufacturing to retain a portion of the implant 460 using shape-setting fixation devices. These openings may not be used for the function of the implant 460. In some embodiments, the first segment or arm 462 and the second segment or arm 464 may include the same number and / or configuration of positioning openings 475. In some embodiments, the first segment or arm 462 and the second segment or arm 464 may include different numbers and / or configurations of positioning openings 475. For example, the number of positioning openings 475 in the first segment or arm 462 may not be equal to the number of positioning openings 475 in the second segment or arm 464, which can be determined by the size of each segment or arm 462, 464 and / or the magnitude of the force required to separate the segments or arms 462, 464 from each other. That is, if a greater force is required to separate the segments or arms 462, 464 and / or more elongated members are needed to apply the necessary separation force to avoid damaging one or more elongated members, the number of positioning openings 475 can be increased. In some embodiments, the first segment or arm 462 may include four positioning openings 475, and the second segment or arm 464 may include two positioning openings 475.

[0125] Using one or more elongated members, a physician can manipulate the configuration of segments or arms 462, 464 such that segments or arms 462, 464 can be separated, released to attach to heart valve tissue, and optionally reseparated to reposition implant 460 before receiving and / or attaching to heart valve tissue. In some embodiments, the first segment or arm 462 and the second segment or arm 464 of implant 460 may be coplanar in a closed configuration, a delivery configuration, and / or an implantation configuration. A physician can apply tension to one or more elongated members via an implant delivery system that applies a force sufficient to overcome the biasing force provided by the central member 466 to the first segment or arm 462 and the second segment or arm 464, and thus separate the first segment or arm 462 and the second segment or arm 464 into an open configuration. In the open configuration, the separation of the first segment or arm 462 and the second segment or arm 464 can define a separation angle relative to the closed configuration (e.g., coplanar). The separation angle can be from about 1 degree to about 180 degrees, from about 10 degrees to about 150 degrees, or from about 15 degrees to about 120 degrees. The separation angle can at least correspond to the uncompressed thickness of the target heart valve tissue (e.g., at the treatment site). The separation angle can determine the separation distance between portions of the first segment or arm 462 and the second segment or arm 464. For example, the separation distance can be defined by the maximum distance between the distal end of the first segment or arm 462 and the distal end of the second segment or arm 464. In some embodiments, the separation distance can be from about 1 mm to about 20 mm, from about 5 mm to about 18 mm, or from about 10 mm to about 15 mm. For example, in some variations, the separation distance can be from about 1 mm, about 5 mm, about 15 mm, about 17 mm, or about 20 mm.

[0126] The physician can also reduce tension in one or more elongated members via the implant delivery system 100, which can allow biasing forces to bring the first segment or arm 462 and the second segment or arm 464 toward each other into the implantation configuration. The implantation configuration may correspond to the first segment or arm 462 and / or the second segment or arm 464 coupled to heart valve tissue. Therefore, the implantation configuration may correspond to the compressed thickness of the target heart valve tissue. Depending on the thickness of the compressed heart valve tissue, the first segment or arm 462 and the second segment or arm 464 may not be coplanar with respect to each other in the implantation configuration. In some embodiments, the first segment or arm 462 and the second segment or arm 464 may be partially or completely coplanar with respect to each other in the implantation configuration.

[0127] The implant 460 described herein may further include one or more visualization openings configured to receive visualization markers that facilitate visualization of the implant 460 (e.g., location and / or configuration) before, during, and / or after implantation. The implant 460 may define one or more visualization openings at any location, such as in one or more of the first segment or arm 462, the second segment or arm 464, and the central member 466. For example, the first segment or arm 462 and / or the second segment or arm 464 may each include one or more visualization openings configured to receive visualization markers (e.g., radiopaque markers). In some embodiments, the visualization openings of the first segment or arm 462 and / or the second segment or arm 464 may be located in their distal portions, allowing the determination of the separation distance between the first arm 462 and the second segment or arm 464. When coupled to the first segment or arm 462 and / or the second segment or arm 464, the visualization markers may be indirectly visible to a physician while the implant 460 is in the patient's body. In some embodiments, the visual markers can be directly visible, for example, via fluoroscopy, echocardiography, and / or other imaging modalities. In this way, the position of the first segment or arm 462 and the second segment or arm 464 relative to each other can be determined by radiopaque markers attached thereto, which can be used to determine the configuration of the implant 460 (e.g., delivery configuration, closed configuration, open configuration, or implantation configuration). Additionally, if segments or arms 462, 464 are separated (e.g., in an open configuration), the visual markers can be used to determine the separation distance between segments or arms 462, 464.

[0128] The visualization opening described herein may include dimensions corresponding to the shape and size of the visualization marker. The visualization opening may have the same shape and size as any other visualization opening, or a different shape and size. In some embodiments, the opening and associated visualization marker may have any shape, such as circular, elliptical, triangular, rectangular, square, or trapezoidal. For example, a substantially circular opening may correspond to a substantially circular radiopaque marker. The visualization opening may include a diameter or length. The diameter or length may correspond to the diameter or width of the visualization marker. The diameter or length of the visualization opening may be about 250 micrometers to about 2 micrometers, about 500 micrometers to about 1.5 mm, or about 500 micrometers to about 1 mm. For example, in some variations, the diameter or length may be about 250 micrometers, about 500 micrometers, about 750 micrometers, or about 1 mm. In some embodiments, the visualization opening may extend through the thickness of the segment or arm 462, 464 described herein (i.e., it is a through-hole).

[0129] In some embodiments, the first visual opening or first set of visual openings defined by the first arm or segment 462 may have a different shape and / or orientation than the second visual opening or second set of visual openings defined by the second arm or segment 464. For example, the first visual opening on the first arm or segment 462 may be vertically elongated (e.g., an ellipse, slit, or rectangle longer along the longitudinal axis of the first arm or segment 462), and the second visual opening on the second arm or segment 464 may be horizontally elongated (e.g., an ellipse, slit, or rectangle longer along the transverse axis of the second arm or segment 464). When the first arm or segment 462 and the second arm or segment 464 are coplanar, the first visual opening and the second visual opening form a "+" shape. When the first arm or segment 462 and the second arm or segment 464 are not coplanar, the first visual marker and the second visual marker form a series of horizontal and vertical shapes.

[0130] In some embodiments, each of the first segment or arm 462 and the second segment or arm 464 may include 0 to 20 visualization openings, such as 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 visualization openings configured to receive visualization markers. The number of visualization openings in the first segment or arm 462 may not be equal to the number of visualization openings in the second segment or arm 464. For example, the number of visualization openings in each segment or arm 462, 464 may be determined by the size of each segment or arm 462, 464. For example, the number of visualization openings in the first segment or arm 462 may be greater than the number of visualization openings in the second segment or arm 464 because the first segment or arm 462 has a larger surface area relative to the second segment or arm 464. In some embodiments, increasing the surface area of ​​the segments or arms 462, 464 may increase the number of their visualization openings, enabling physicians to identify the location of larger segments or arms 462, 464. In some embodiments, one or more visual markers may be attached to the first segment or arm 462 and / or the second segment or arm 464 instead of being received in the corresponding visual opening, which may facilitate the attachment of additional visual markers to the device after the initial assembly of the implant 460.

[0131] f. Board

[0132] The implant 460 may further include one or more plates (e.g., a first segment or arm 462 and / or a second segment or arm 464) configured to be attached to the implant 460. One or more plates may be attached to the implant 460 such that the plates remain securely attached to the implant 460 during the initial implantation process and any subsequent repositioning. For example, a first plate may be attached to the first segment or arm 462, and a second plate may be attached to the second segment or arm 464. The first plate may include a shape corresponding to at least a portion of the first segment or arm 462 and / or the second plate may include a shape corresponding to at least a portion of the second segment or arm 464. Thus, in some embodiments, each of the first and second plates may include one or more of flat and curved portions. The curved portions of the first and second plates may be shaped to mate with the curved portions of the previously described first segment or arm 462 or second segment or arm 464. One or more plates may be further configured to be releasably attached to heart valve tissue, which may facilitate repositioning of the implant 460. One or more plates may include any friction element of friction element 470 as described in detail above and in any configuration described herein.

[0133] One or more plates may further include one or more openings (e.g., positioning openings 475) configured to receive one or more elongated members, which may facilitate opening and / or closing of the implant 460. For example, a first plate may include one or more positioning openings 475 having a similar size and location to one or more positioning openings 475 of the first segment or arm 462. Additionally or alternatively, a second plate may include one or more positioning openings 475 having a similar size and location to one or more positioning openings 475 of the second segment or arm 464. In this way, one or more elongated members may pass through the positioning openings of at least one of the first plate, the first segment or arm 462, the second plate, and / or the second segment or arm 464. In some embodiments, the first plate and / or the second plate may each include one or more visualization openings configured to receive visualization markers. In some embodiments, the first plate and / or the second plate may not include one or more visualization openings, such that the first plate and / or the second plate may cover one side of the visualization opening of the respective first segment or arm 462 and the second segment or arm 464, and thus provide a mounting surface (e.g., a support). In this manner, the visual marker received within one of the visual openings in the first segment or arm 462 and / or the second segment or arm 464 can be securely mounted to the first plate or the second plate.

[0134] The first and second plates described herein can be respectively coupled to the first segment or arm 462 and the second segment or arm 464. For example, in some embodiments, the first and second plates can be fixedly attached (e.g., permanently) to the first segment or arm 462 and the second segment or arm 464, respectively, so that the implant 460 can maintain its structural integrity before, during, and after the implantation procedure. The first and second plates can be coupled to the first segment or arm 462 and the second segment or arm 464 via any suitable fastening technique, such as, for example, via welding, adhesives, and / or mechanical fasteners (e.g., screws, bolts)). The coupling method can depend at least in part on the materials of the plates and / or segments or arms 462, 464.

[0135] In some embodiments, the plates and segments or arms 462, 464 may each be made of metal (e.g., stainless steel, nitinol) such that the first plate can be welded to the first segment or arm 462, and the second plate can be similarly welded to the second segment or arm 464. In some embodiments, the plates and arms may each be made of plastic such that the plates can be bonded to the respective segments or arms 462, 464 using a polyurethane adhesive, which may be non-toxic to humans and therefore suitable for medical devices. The first and second plates may each have a thickness of about 50 micrometers to about 500 micrometers, about 50 micrometers to about 300 micrometers, about 50 micrometers to about 200 micrometers, or about 75 micrometers to about 125 micrometers. For example, in some variations, the first and second plates may each have a thickness of about 50 micrometers, about 75 micrometers, about 100 micrometers, about 200 micrometers, or about 250 micrometers.

[0136] g. Visual markers

[0137] Implant 460 can be implanted into a patient without direct visualization of implant 460, which can reduce the number of components associated with surgery, facilitate minimally invasive surgery, and / or reduce the size of implant 460 and / or delivery system. For example, implant 460 can be implanted into a patient using visualization via X-ray, CT, or similar medical imaging means. In some embodiments, implant 460 may include one or more visualization markers (e.g., one or more radiopaque markers) configured to allow a user to indirectly visualize implant 460 and thereby determine the location of one or more elements of implant 460. As described above, implant 460 may define one or more visualization openings configured to receive one or more visualization markers. In some embodiments, a first plate and a second plate may be configured to provide mounting surfaces for one or more visualization markers. In this way, the precise location of implant 460 relative to a heart valve can be determined. Furthermore, the position of the first segment or arm 462 and the second segment or arm 464 relative to each other can also be determined via visualization markers attached thereto. Therefore, it can be determined whether the first segment or arm 462 and the second segment or arm 464 are coplanar (e.g., in a closed configuration) or whether they are separated (e.g., in an open configuration), and if so, the distance by which the segments or arms 462 and 464 are separated can be determined.

[0138] The visual markers described herein may include dimensions corresponding to the shape and size of the visual openings that receive them. In some embodiments, the width of the visual markers may be from about 250 micrometers to about 2 mm, from about 500 micrometers to about 1.5 mm, or from about 500 micrometers to about 1 mm. For example, in some variations, the width may be from about 250 micrometers, about 500 micrometers, about 750 micrometers, or about 1 mm. The height of the visual markers may be from about 50 micrometers to about 300 micrometers, from about 100 micrometers to about 300 micrometers, or from about 150 micrometers to about 300 micrometers. In embodiments where the visual openings extend through segments or arms 462, 464, the height of the visual markers may be from about 200 micrometers to about 300 micrometers, including about 250 micrometers.

[0139] The visual marker can be attached to the implant 460 such that it remains securely attached to the implant 460 for the entire duration the implant remains in the patient's body. For example, the visual marker can be attached to arms 462, 464 and / or plates using welding, adhesives, and / or mechanical fasteners (e.g., screws, bolts). The attachment method can depend at least in part on the materials of the visual marker, plate, and / or arm. In some embodiments, the visual marker may be made of gold, platinum, iridium, tantalum, or other radiopaque materials. In some embodiments, the visual marker (e.g., a radiopaque marker) may include platinum and can be welded to the implant 460 made of nitinol.

[0140] Although received within a visualization opening as described above, in some embodiments, one or more visualization markers may be attached to the surface of the first segment or arm 462 and / or the second segment or arm 464 or the central member 466 without using the opening. Furthermore, in some cases, the visualization markers may be in the form of visual markers on the surface of the implant 460 (e.g., the first segment or arm 462 and / or the second segment or arm 464, the central member 466), intended for endoscopic observation without the use of radiology.

[0141] h. Covering

[0142] Implant 460 may include one or more covers 468 configured to attach to and, in some cases, surround at least a portion of implant 460. In some embodiments, covers 468 may extend along at least a portion of the attachment and engagement portions of implant 460. For example, covers 468 may cover at least a portion of each of a first segment or arm 462 and / or a second segment or arm 464. In some embodiments, covers 468 may cover each of a first segment or arm 462 and a second segment or arm 464, except for its plurality of positioning openings 475 and / or friction elements 470. Covers 468 may cover a central member 466 and / or may cover a support member 480. When used to cover the support member 480, covers 468 may be configured to alter one or more physical properties of the heart valve tissue, such as its thickness, length, width, curvature, and / or stiffness. The cover 468 can also help provide an extendable engagement surface for receiving heart valve tissue and can be combined with the support member 480 to advantageously provide an engagement surface for heart valve tissue. The cover 468 can also provide a surface on which native tissue can grow, which can help improve outcomes and / or further reduce heart valve regurgitation, as the native tissue naturally connects to portions of the heart valve after the implantation procedure. Additionally or alternatively, the cover 468 can operate as a flexible extension of the implant 460, allowing a larger surface area of ​​heart valve tissue (e.g., a second native leaflet) to contact the implant 460 and / or to fill larger gaps between the native leaflets. In these embodiments, the cover 468 can further reduce the precision required by the physician during the implantation procedure because the cover can increase the overall size of the implant 460.

[0143] The cover 468 may be made of a material with sufficient flexibility to accommodate movement of the attachment and / or engagement portions without tearing, breaking, or otherwise damaging. As described above, the material of the cover 468 may promote the growth of native heart valve tissue. Therefore, in some embodiments, the cover 468 may comprise one or more of fabrics (e.g., textiles) and polymers (e.g., polyester, polytetrafluoroethylene). Additionally or alternatively, the cover 468 may be woven, braided, and / or layered using one or more materials. The material and texture of the cover 468 may be determined based on biocompatibility and / or durability with heart valve tissue. The cover 468 may be attached to the implant 460 using any suitable technique, such as, for example, sutures, frenulums, knots, adhesives, and / or elastic bands.

[0144] In some embodiments, the cover 468 may include three portions, such as a first portion configured to attach to a support member 480, a second portion configured to extend from the support member, and a third portion configured to attach to an attachment portion (e.g., at least a portion of a first segment or arm 462 and a second segment or arm 464). These portions may be integrally formed or may be separate from each other. For example, the first and second portions may be integrally formed (e.g., a first cover), and the third portion may be formed separately (e.g., a second cover), such that the first and second covers can be attached to the implant 460 during assembly.

[0145] In another example, the cover 468 may include a first portion of a plurality of support members 480 configured to be coupled to the engagement portion, wherein one or more (e.g., all) of the support members 480 support the cover 468. The cover 468 may further include a second portion that may extend proximally from the first portion, such that the second portion may not directly contact or otherwise cover the implant body (e.g., the second portion may be without support members 480). Thus, the second portion may increase one or more dimensions of the implant 460 (e.g., the engagement portion) and may provide additional volume to the implant body by defining a 3D shape. In some embodiments, the first portion may be coupled to the second portion along the distal edge of the second portion and / or along the width of the second portion. The second portion may be rolled up and / or folded (e.g., accordion fold) and may be bent along the lateral dimension (e.g., width) of the implant 460. For example, in some embodiments, the second portion may be or may include a cylindrical cuff that may be formed and secured (e.g., using mechanical fasteners such as sutures, adhesives, and / or the like) from a rolled-up material (e.g., a covering material such as fabric) such that it maintains its rolled-up configuration during use. In these embodiments, the second portion may provide a flexible and / or non-rollable extension that may be configured to increase the size of the implant 460. The third portion may be configured to attach to the attachment portion such that the third portion covers at least a portion of the first segment or arm 462 and the second segment or arm 464. The third portion may cover the friction element 470 of the first segment or arm 462 and / or the second segment or arm 464. In some embodiments, some or all of the friction elements 470 of the first segment or arm 462 and / or the second segment or arm 464 may extend through (e.g., pierce) the covering 468 such that the friction element 470 can directly engage the native leaflet tissue.

[0146] Figure 5A This is an illustration of a short catheter implant delivery system 500 according to an embodiment, including a handle assembly 505, an implant catheter 530, and an implant retainer 535. Figure 5BA close-up of the distal end of an implant delivery system 500 according to an embodiment is shown. As shown, an implant catheter 530 includes four sub-tubes extending therethrough. Each sub-tube may define a lumen 533 configured to receive an elongated member (e.g., a tether, not shown) extending therethrough. Each tether extends along the length of the implant catheter 530 within each lumen 533 of the respective sub-tube, wherein at least one end or portion of the tether is anchored (e.g., detachably anchored) to a handle assembly 505. An implant retainer 535 is coupled to the distal end of the implant catheter 530 and includes four channels, each channel configured to receive a corresponding portion of the tether. For example, each tether may extend from the distal end of the respective sub-tube and through a corresponding channel in the implant retainer 535, such that each tether can be coupled to a portion of an implant disposed in the implant retainer 535. Although not shown, in some embodiments, a first tether (e.g., an atrial tether) may be configured to be attached to a first arm (e.g., an atrial arm) of the implant, and a second tether (e.g., a ventricular tether) may be configured to be attached to a second arm (e.g., a ventricular arm) of the implant.

[0147] Figure 5CA handle assembly of a short catheter implant delivery system 500 is shown. As shown, the handle assembly 505 includes an AT actuator 542 and a VT actuator 552. The AT actuator 542 is configured to be coupled to an atrial tether (not shown), and the VT actuator 552 is configured to be coupled to a ventricular tether (not shown). The AT actuator 542 and VT actuator 552 may be configured to move linearly along the length of the handle assembly 505 in response to user manipulation to apply tension and / or introduce slack into the tether in order to control the configuration of the implant 560. For example, to position the implant 560 around a portion of a heart valve, the AT actuator 542 may move proximally to tighten the atrial tether, such that the first arm of the implant 560 is stabilized in the implant retainer 535. The VT actuator 552 can then be moved proximally to tighten the ventricular tether, thereby converting the implant 560 into an open configuration in which the second arm (not shown) of the implant 560 moves away from the first arm (not shown). Once the implant 560 is positioned to clamp part of the heart valve tissue, the VT actuator 552 can be moved distally to convert the implant 560 into an implant configuration in which the first and second arms apply clamping forces to the heart valve tissue. To confirm the position of the implant 560 relative to the heart valve, the AT actuator 542 and the VT actuator 552 can be moved distally to introduce slack in the atrial and ventricular tethers, allowing the distal end of the implant delivery system to move away from the implant 560 without detaching the implant 560 from the heart valve tissue. This partial disengagement allows the position of the implant 560 to be checked after initial deployment. If necessary, proximally moving the AT actuator 542 and the VT actuator 552 can reposition the implant 560. To completely detach implant 560 from implant retainer 535, the atrial and ventricular tethers can be removed (e.g., cut, untied, separated, etc.) and pulled out from the proximal end of the implant delivery system (e.g., by the user). Implant delivery system 500, implant retainer 535, and implant 560 may be structurally and / or functionally similar to implant delivery system 100, implant retainers 135, 335, and implants 160, 360, 460; therefore, certain aspects of delivery system 500, implant retainer 535, and implant 560 are not referred to herein. Figures 5A to 5C To describe in further detail.

[0148] Figure 6An image is shown of the proximal control mechanism of each catheter in an implant delivery system. The proximal control mechanism may be separate or may be included in a handle assembly. As shown, the implant delivery system may include a guide catheter 610 coupled to a guide catheter (GC) actuator 612, a delivery catheter 620 coupled to a delivery catheter (DC) actuator 622, and an implant catheter 630 coupled to an implant catheter (IC) actuator 632. The distal end of the implant catheter 630 is coupled to an implant retainer 635, and the implant retainer 635 is configured to receive an implant 660. The delivery catheter 630 and the guide catheter 610 may be manipulated via the DC actuator 622 and the GC actuator 612, respectively. In some embodiments, catheters 610, 620, and 630 may have varying thicknesses along their length. For example, conduits 610, 620, and 630 may have greater rigidity at their proximal ends and less rigidity at their distal ends, allowing the less rigid portions of conduits 610, 620, and 630 to bend, while the more rigid portions remain straight and stabilize the delivery system. In some embodiments, guide conduit 610 and delivery conduit 620 may each have a proximal portion with a first hardness, an intermediate portion with a second hardness lower than the first hardness, and a distal portion with a third hardness lower than the second hardness. Delivery conduit 620 and guide conduit 630 may each include a welded ring at their distal ends and two hinge members (e.g., draw wires), the two hinge members including a first end coupled to the welded ring and a second end coupled to a proximal control mechanism. In some embodiments, the hinge members may be coupled to the welded ring at 180-degree intervals. In some embodiments, DC actuator 622 and / or GC actuator 612 may each include a rack and pinion assembly. The gears on each rack and pinion assembly can be calibrated to enable independent and precise manipulation of each conduit. A user can rotate a knob 613 on the GC actuator 612 to manipulate the guide catheter 610. A user can rotate a knob 623 on the DC actuator 622 to manipulate the delivery catheter 620. Each catheter 610, 620, 630 may include a flushing port connected to its inner lumen to help reduce frictional contact between catheter shafts and prevent air from entering the patient's circulatory system.

[0149] In some embodiments, the guiding catheter 610 may be a 24Fr catheter, the delivery catheter 620 may be a 16Fr catheter, and the implantation catheter 620 may be a 12Fr catheter. In some embodiments, the maximum angle at which the delivery catheter 620 can be manipulated is greater than the maximum angle at which the guiding catheter 610 can be manipulated. In some embodiments, the length of the maneuverable portion of the delivery catheter 620 may be less than the length of the maneuverable portion of the guiding catheter 610. In some embodiments, the guiding catheter 610 may be manipulated to an angle between about 0 degrees and about 150 degrees from the longitudinal axis of the catheter 610, including all ranges and subranges therebetween. In some embodiments, the length of the maneuverable portion of the guiding catheter 610 may be in the range of about 30 mm to about 80 mm, including all ranges and subranges therebetween. In some embodiments, the delivery catheter 620 may be manipulated to an angle between about 0 degrees and about 150 degrees, including all ranges and subranges therebetween. In some embodiments, the length of the maneuverable portion of the delivery catheter 620 may be in the range of about 20 mm to about 70 mm, including all ranges and subranges therebetween.

[0150] The implant catheter 630 can be linearly moved within the delivery catheter 620 (e.g., in proximal and distal directions) via a linear slider 633 on the IC actuator 632. The implant catheter 630 may have a stiffness or rigidity of 35D. The implant catheter 630 may be configured for maneuverability and torsion, such that the implant catheter 640 can extend linearly from the delivery catheter 620 even when the delivery catheter 620 is in a curved configuration. Therefore, the trajectory of the implant 660 can be independent of the curvature of the implant catheter 630, which can allow for precise positioning and leaflet capture. The implant catheter 630 may include a plurality of hypotubes (e.g., four hypotubes) extending therethrough. Each hypotube may include an elongated member (e.g., an atrial tether and / or ventricular tether) extending therethrough. As shown, the IC actuator 632 may further include one or more actuators, each actuator coupled to the elongated member to control the tension of the elongated member. One or more actuators can be any suitable actuator, such as, for example, a knob, a rotary screw, a button, a slider, etc. In some embodiments, IC actuator 632 may include a first rotary screw configured to control tension on an atrial tether and a second rotary screw configured to control tension on a ventricular tether. Rotation of the rotary screw in a first direction may apply tension to the tether, and rotation of the rotary screw in a second direction may release tension from the tether. Implant catheters 610, 620, 630, implant retainer 635, and implant 660 may be structurally and / or functionally similar to implant catheters 110, 120, 130, implant retainers 135, 335, and implants 160, 360, 460; therefore, certain aspects of implant catheters 610, 620, 630, implant retainer 635, and implant 660 are not referred to herein. Figure 6 To describe in further detail.

[0151] Figures 7A to 7CThe maneuverability of a three-catheter system according to an embodiment of an implant delivery system is illustrated. As shown, the implant delivery system includes a guide catheter 710, a delivery catheter 720, and an implant catheter 730. The implant catheter 730 is coupled to an implant retainer 735 that holds an implant 760. The guide catheter 710 is maneuverable, the delivery catheter 720 is maneuverable, and the implant catheter 730 may be non-maneuverable. However, the implant catheter 730 may be linearly translated relative to the delivery catheter 720 and the guide catheter 710 and rotate about its own longitudinal axis. In some embodiments, the implant catheter 730 may be twisted (e.g., rotated about its longitudinal axis). In some embodiments, the guide catheter 710 is maneuverable in one plane and is configured to achieve a curvature corresponding to the path through the septum into the left atrium. Although not shown, the delivery catheter 720 may have biplane maneuverability (e.g., maneuverability in two planes). The three-catheter system allows the user to achieve a composite curve that may lie in multiple planes at the distal end of the delivery system. In some embodiments, the three-catheter system can achieve angles of up to about 180 degrees, about 175 degrees, about 170 degrees, about 165 degrees, about 160 degrees, about 155 degrees, and about 150 degrees distally, including all ranges and subranges therein. Implant catheters 710, 720, 730, implant retainers 735, and implants 760 may be structurally and / or functionally similar to implant catheters 110, 120, 130, 530, 630, implant retainers 135, 335, 535, 635, and implants 160, 360, 460, 560, 660; therefore, certain aspects of implant catheters 710, 720, 730, implant retainers 735, and implants 760 are not referred to herein. Figures 7A to 7C To describe in further detail.

[0152] Figure 8 This is a diagram of an implant retainer 835 of an implant delivery system according to an embodiment. The implant retainer 835 includes a proximal end 835A configured to be coupled to the distal end of an implant catheter (not shown) of the delivery system. The implant retainer 835 has a curved distal end 835B. The curved distal end 835B can be non-invasive to prevent damage to tissue during implant delivery. The implant retainer 835 may further define a first portion configured to receive the implant (…). Figure 8 The implant retainer 835 includes a cavity (not shown) and a proximal engagement surface (e.g., a flat portion 837) configured to receive a second portion of the implant. The implant retainer 835 includes a pair of atrial channels 836A, 836B and a pair of ventricular channels 838 (not shown). Figure 8Only one ventricular channel 838 is shown in the diagram (as another channel is located directly behind the shown channel in the side view). Each channel may be configured to receive an elongated member (e.g., a tether) to attach an implant to an implant retainer 835 and to allow the implant to change configurations. A first atrial channel 836A may define a first opening at the proximal end of a flat portion 837 of the implant retainer 835. A second atrial channel 836B may define a second opening at the proximal end of a cavity of the implant retainer 835. When the implant is attached to the implant retainer 835, the first and second openings may correspond to positioning openings on a first arm of the implant. Ventricular channels 838 may define a third and a fourth opening, respectively, at the distal end of the implant retainer 835. The implant retainer 835 may be structurally and / or functionally similar to implant retainers 135, 335, 535, 635, and 735; therefore, certain details of the implant retainer 835 are not referred to herein. Figure 8 Describe it.

[0153] Figures 9A to 9C An image of an implant retainer 935 of an implant delivery system including an implant 960 coupled thereto, according to an embodiment, is shown. As shown, the implant retainer 935 includes a proximal end coupled to an implant catheter and a curved distal end. The implant retainer 935 defines a cavity in which a first portion (e.g., a central portion and a first portion of the second arm) of the implant 960 is disposed, and an engagement surface (e.g., a flat portion, surface feature, etc.) in which a second portion (e.g., a first arm 962 and a second portion of the second arm) of the implant 960 may be disposed. In some embodiments, the engagement surface may be a flat portion of the implant retainer 935. In some embodiments, the engagement surface may be curved or shaped to correspond to a portion of the implant 960. In some embodiments, the engagement surface may include one or more surface features to assist in engaging that portion of the implant 960. An atrial tether 940 is configured to extend through a first atrial canal defining a first opening at the proximal end of the flat portion, through a positioning opening on the first arm 962 of the implant 960, and into a second atrial canal defining a second opening at the proximal end of the cavity. The ventricular tether 950 may be configured to extend through a first ventricular passage defining a third opening at the distal end of the implant retainer 935, through a positioning opening on the second arm 964 of the implant 960, and into a second ventricular passage defining a fourth opening at the distal end of the implant retainer 935 adjacent to the third opening.

[0154] like Figure 9BAs shown, the atrial tether 940 can be tightened such that the first arm 962 of the implant abuts the engagement surface of the implant retainer 935. Tightening the atrial tether 940 stabilizes the first arm of the implant 960, such that when a force is applied to the second arm 964 of the implant 960, the first arm 962 remains in place. When the ventricular tether 950 is tightened, the second arm 964 of the implant moves away from the first arm 962 of the implant 960, thereby converting the implant 960 into an open configuration, as... Figure 9C As shown. Implant retainers 935 and 960 may be structurally and / or functionally similar to implant retainers 135, 335, 535, 635, 735, 835 and implants 160, 360, 460, 560, 660; therefore, certain details of implant retainer 935 are not referred to herein. Figures 9A to 9C Describe it.

[0155] Figures 10 to 15 Implants 1060, 1160, 1260, 1360, 1460, and 1560 for treating valvular regurgitation according to various embodiments are depicted. For example... Figure 10 As shown, the implant 1060 includes a first arm 1062, a second arm 1064, and a central portion 1066. The first arm 1062 may include three positioning openings 1075 configured to receive one or more atrial tethers for attaching the first arm 1062 to an implant retainer. Although not shown, the first arm may further include one or more friction elements configured to fix the first arm 1062 relative to heart valve tissue when the implant 1060 is implanted. The second arm 1064 may also include two positioning openings 1077 configured to receive one or more ventricular tethers for attaching the second arm 1064 to the implant retainer. The first arm may further include positioning openings 1079A and 1079B at its proximal end. Positioning opening 1079A may be located at the center of the proximal end of the first arm 1062, and positioning opening 1079B may be located on opposite sides of the proximal end of the first arm 1062. The second arm 1064 may further include one or more friction elements 1070 to secure the implant 1060 to cardiac tissue. The central portion 1066 may include one or more horizontal struts 1061 disposed along the length of the central portion 1066. In some embodiments, a cover may be disposed over a portion of the central portion 1066 and the second arm 1064. The implant 1060 may be formed of a material including nitinol, such that the implant 1060 is deformable between configurations (e.g., delivery configuration, opening configuration, closing configuration, implantation configuration, etc.). The implant 1060 may be structurally and / or functionally similar to any of the implants described herein, and therefore is not referred to. Figure 10 Describe certain aspects of implant 1060 in detail.

[0156] Similar to Figure 10 The implant 1060, Figure 11 An implant 1160 is shown, comprising a first arm 1162 including three positioning openings 1175, a second arm 1164 including two positioning openings 1177, and a central portion 1166. The first arm may include additional positioning openings 1179A, 1179B at its proximal end. The first and second arms may include one or more friction elements 1170 configured to secure the implant 1160 to cardiac tissue. The central portion 1166 includes a horizontal strut 1161 disposed along its length. Figure 10 In contrast to implant 1060, implant 1160 includes four support members 1180 welded to the implant frame. For example, a first and second support member may be disposed on a first side of the central portion 1166, and a third and fourth support member may be disposed on a second side of the central portion 1166 opposite to the first side. Each support member may include a first end weldable to the proximal end of a first arm and a second end weldable to the proximal end of the central portion 1166. In some embodiments, a cover may be mounted on the support member 1180.

[0157] Figure 12 The implant 1260 may further include: a first arm 1262 and a second arm 1264, the first and second arms including positioning openings 1275, 1277 and a friction element 1270; a central member 1266 including a horizontal strut 1261; and four support members 1280. The first arm 1262 may include additional positioning openings 1279A, 1279B at its proximal end. The implant 1260 may differ from... Figure 11 The implant 1160 differs in that the support member 1280 of the implant 1260 can be integrated into the implant frame (instead of being welded) and can extend further away from the central member 1266, so that the implant 1260 has a greater maximum width. Figure 13 Implant 1360 is shown, comprising: a first arm 1362 and a second arm 1364, the first and second arms including positioning openings 1375 and 1377; a central member 1366; and four support members 1380. Implant 1360 may include additional positioning openings 1379A and 1379B on the proximal end of the first arm 1362. Implant 1360 may differ from... Figure 12The implant 1260 differs in that the central member 1366 does not include a horizontal strut, the thickness of the support member 1380 is reduced, and / or the total radius of curvature of the support member 1380 is greater than the total radius of curvature of the implant 1260. Furthermore, each support member 1380 may include a free end (e.g., a free proximal end) not connected to the implant frame. Although not shown, in some embodiments, the implant 1360 may optionally include friction elements on the first arm 1362 and / or the second arm 1364. In some embodiments, the implant 1360 may not include friction elements.

[0158] Figure 14 Implant 1460 is shown, comprising: a first arm 1462 and a second arm 1464, the first and second arms including positioning openings 1475, 1477 and a friction element 1470; a central member 1466; and four support members 1480. Implant 1460 may differ from... Figure 13 The implant 1360 differs in that the width of the second arm 1464 (e.g., a ventricular arm) is increased and the width of the opening defined by the first arm (e.g., an atrial arm) is increased to accommodate the second arm 1464. Consequently, the width of the side of the first arm 1462 surrounding the second arm 1464 is correspondingly reduced. Additionally, the positioning opening on the opposite side proximal to the first arm (e.g., 1379B) is removed. Therefore, the implant 1460 may include only one positioning opening 1479 proximal to the first arm 1462.

[0159] Figure 15 Implant 1560 is shown, comprising: a first arm 1562 and a second arm 1564, the first and second arms including positioning openings 1575, 1577 and a friction element 1570; a central member 1566; and four support members 1580. Implant 1560 may differ from... Figure 14 The implant 1460 differs in that the width of the first arm 1562 (e.g., an atrial arm) is greater than the width of the second arm 1462. Additionally, the second arm 1564 has been modified to have two portions with two different widths. A first portion of the second arm 1564, offset into the opening of the first arm 1562, has a first width, and a second portion of the second arm 1564, not disposed in the opening of the first arm 1562, has a second width greater than the first width. The implant 1560 further includes an opening 1576 disposed at the distal end of the first arm 1562 and configured to receive a radiopaque marker. The implant 1560 may further include an opening on the second arm 1564 configured to receive a radiopaque marker. These radiopaque openings allow the user to locate the implant 1560 via imaging during implantation. The implant design will refer to... Figures 16A to 16C To describe in further detail.

[0160] Figures 16A to 16C A front perspective view of the implant 1660 according to an embodiment is shown. Figure 16A ), rear perspective view ( Figure 16B ) and bottom view ( Figure 16C The implant 1660 may include an attachment portion 1602 and an engagement portion 1604. The attachment portion 1602 may include a first segment or arm 1662 and a first portion of a second segment or arm 1664. The engagement portion 1604 may include a second portion of the second segment or arm 1664 and a central member 1666. The first arm 1662 may extend from a first end of the central member 1666, and the second arm 1664 may extend from a second end of the central member 1666. As shown, when in a closed configuration and / or an implanted configuration, at least a portion of each of the first arm 1662 and the second arm 1664 may be coplanar. In some embodiments, this coplanarity may facilitate the secure attachment of the implant 1660 to heart valve tissue. Additionally, as shown, the first arm 1662 and the second arm 1664 may each have a plurality of friction elements 1672, 1673, 1674a, 1674b extending therefrom. Friction elements 1672, 1673, 1674a, and 1674b can be configured to apply frictional force to heart valve tissue. Friction elements 1672 and 1673 of the first arm 1662 can be coupled to or integrally formed with the tissue-facing surface of the first arm 1662. Similarly, friction elements 1674a and 1674b of the second arm 1664 can be coupled to or integrally formed with the tissue-facing surface of the second arm 1664. Therefore, friction elements 1672, 1673, 1674a, and 1674b can be configured to non-destructively engage heart valve tissue when it is received between the first arm 1662 and the second arm 1664. For example, the flat portions of the first arm 1662 and the second arm 1664 can be coplanar in a plane, and friction element 1672 can extend or protrude beyond that plane. Therefore, when the first arm 1662 and the second arm 1664 are coplanar and clamped around the leaflet, the friction element 1672 can extend at least partially into the leaflet tissue. As shown, when the implant can be in a closed configuration, the friction elements 1672, 1673 can extend beyond the second arm 1664, and / or the friction element 1674 can extend beyond the first arm 1662. That is, the friction elements 1672, 1673 of the first arm 1662 may not be coplanar with the second arm 1664, and the friction element 1674 may not be coplanar with the first arm 1662.

[0161] In some embodiments, friction elements 1674a and 1672 in attachment portion 1602 may have angles with the surfaces of the corresponding arms or segments 1662 and 1664, compared to friction elements 1674b and 1673 in engagement portion 1604. For example, friction element 1672 may form a first angle with the surface of the first segment or arm 1662, and friction element 1674a may form a second angle with the surface of the second segment or arm 1662. In some embodiments, the first and second angles may be equal. In some embodiments, friction element 1674b may form a third angle with the surface of the first segment or arm 1662, and friction element 1673 may form a fourth angle with the surface of the second segment or arm 1664. In some embodiments, the third and fourth angles may be equal. The first and second angles may be greater than the third and fourth angles, such that friction elements 1674b and 1673 do indeed interfere with each other when the implant 1660 is in a closed configuration.

[0162] Extending from the first arm 1662 may be multiple support members, such as a first support member 1681, a second support member 1682, a third support member 1683, and a fourth support member 1684. The multiple support members 1681, 1682, 1683, and 1684 may be configured for elastic deflection, including during delivery and / or engagement with the native leaflet. One or more of the support members 1681, 1682, 1683, and 1684, including all support members, may extend from the first arm 1662 to a free end, which may further facilitate the deformability of each of the support members 1681, 1682, 1683, and 1684. In some variations, the free end of each of the support members 1681, 1682, 1683, and 1684 may be positioned relative to the central member 1666 to facilitate delivery, engagement, and / or contact with cardiac valve tissue. For example, when the implant 1660 is in a closed configuration, the free ends of each of the support members 1681, 1682, 1683, and 1684 may be coplanar with the proximal surface of the central member 1666. This coplanarity of the free ends of the support members 1681, 1682, 1683, and 1684 with the proximal surface of the central member 1666 can maximize the volume defined by the engagement portion 1604. In some cases, the first support member may be a mirror image of the second support member or otherwise have a shape that corresponds to and is opposite to the second support member. For example, in some embodiments, the first support member on a first side of the central member may be a mirror image of the second support member on a second side of the central member. As shown, the first support member 1681 and the second support member 1682 may be mirror images of their counterparts in the third support member 1683 and the fourth support member 1684. Upon implantation, the support members 1681, 1682, 1683, and 1684 can independently deform or otherwise buckle, such that the support members 1681, 1682, 1683, and 1684 do not need to maintain a mirror configuration. In some embodiments, the implant 1660 may further include one or more positioning openings 1675A, 1675B, and 1675C defined by the first arm or segment 1662, as shown in reference to Figures 25 to 26 Further detailed description.

[0163] Figures 17A to 17GDifferent views of an implant 1760 for treating valvular regurgitation in a closed configuration according to an embodiment are shown. The closed configuration may correspond to a predetermined configuration formed by a manufacturing process, and the implant 1760 may be made of a material (e.g., nitinol) capable of returning to the predetermined configuration after deformation, for example, during a delivery process. The predetermined configuration of the implant 1760 may facilitate the biasing forces described herein. The implant 1760 may include an attachment portion 1702 and an engagement portion 1704, as previously described. The attachment portion 1702 may include a first segment or arm 1762 and a first portion of a second segment or arm 1764, such as a planar portion 1724. The engagement portion 1704 may include a second portion of the second segment or arm 1764 (such as a curved portion 1726) and a central member 1766.

[0164] The attachment portion 1702 may include a length between about 1 mm and about 15 mm, about 2 mm and about 12 mm, about 4 mm and about 10 mm, or about 5 mm and about 7 mm. For example, in some variations, the length of the attachment portion 202 may be about 4 mm, about 5 mm, about 6 mm, about 6.5 mm, about 7 mm, or about 10 mm. The joining portion 1704 may include a length between about 1 mm and about 15 mm, about 2 mm and about 12 mm, about 4 mm and about 10 mm, or about 5 mm and about 7 mm. For example, in some variations, the length of the joining portion 1704 may be about 4 mm, about 5 mm, about 6 mm, about 6.5 mm, about 7 mm, or about 10 mm. The ratio of the length of the attachment portion 1702 to the length of the joining portion 1704 may be between about 1:1 and about 1.5:1. In some variations, each of the first segment or arm 1762 and the second segment or arm 1764 may include one or more planar portions and curved portions. Figure 17E As shown, the first arm 1762 may include a planar portion 1714 and a curved portion 1716. The curved portion 1716 may extend from the central member 1766. In some variations, the attachment portion 1702 may include a planar portion 1714 and a curved portion 1716. Similarly, the second arm 1764 may include a planar portion 1724 and a curved portion 1726, as... Figure 17D As shown. The curved portion 1726 may extend from the central member 1766.

[0165] As shown, the first arm 1762 may include a dimension larger than that of the second arm 1764, which allows the second arm 1764 to be inserted into the first arm 1762. For example, the second arm 1764 may be received within an intermediate opening 1763 defined by the first arm 1762. The intermediate opening 1763 may be sized such that a gap can be formed between the first arm 1762 and the second arm 1764. This gap may facilitate the extension of a cover (not shown) through the opening 1763 and between the first arm 1762 and the second arm 1764. Thus, the first arm 1762 may include a width 1711 and a length 1712. In some variations, the width 1711 may be between about 2 mm and about 10 mm, about 2 mm and about 9 mm, about 4 mm and about 8 mm, or about 4 mm and about 7 mm. For example, in some variations, the width 1711 may be about 2 mm, about 4 mm, about 5 mm, about 5.5 mm, about 6 mm, or about 7 mm. The length 1712 can be between about 2 mm to about 12 mm, about 3 mm to about 11 mm, about 5 mm to about 10 mm, or about 6 mm to about 8 mm. For example, in some variations, the length 1712 can be about 4 mm, about 5 mm, about 6 mm, about 7 mm, or about 8 mm. In contrast, the second arm 1764 can include a first width 1720, a second width 1721, and a length 1722. As previously described, the second arm 1764 can include varying widths to reduce mechanical stress associated with the connecting heart valve tissue. The first width 1720 can be greater than the second width 1721. Each of the first width 1720 and the second width 1721 can be less than the width 1711 of the first arm 1762. The transition from the first width 1720 to the second width 1721 can occur at any point along the longitudinal dimension (e.g., length) of the second segment or arm 1764, such as about one-third of the distance from the distal edge of the second segment or arm 1764.

[0166] In some variations, the transition between widths 1720 and 1721 can be gradual, thereby reducing stress concentration. In some variations, the first width 1720 can be between about 0.25 mm and about 8 mm, about 1 mm and about 5 mm, about 2 mm and about 4 mm, or about 2.5 mm and about 3.5 mm. For example, in some variations, the first width 1720 can be about 2 mm, about 2.5 mm, about 3 mm, or about 3.5 mm. In some variations, the second width 1721 can be between about 1 mm and about 5 mm, about 2 mm and about 4 mm, about 2.5 mm and about 3.5 mm, or about 2.5 mm and about 3 mm. For example, in some variations, the second width 1721 can be about 2 mm, about 2.5 mm, about 2.75 mm, or about 3 mm. The length 1722 can be less than the length 1712. In some variations, the length 1722 may be between about 2 mm to about 12 mm, about 3 mm to about 12 mm, about 5 mm to about 10 mm, or about 6 mm to about 8 mm. For example, in some variations, the length 1722 may be about 5 mm, about 6 mm, about 7 mm, or about 8 mm.

[0167] The first arm 1762 may define a plurality of openings in its distal portion, which may be configured to receive one or more elongated members (e.g., sutures) and / or visual markers (e.g., radiopaque markers). As shown, the first arm 1762 may include a plurality of positioning openings (e.g., suture holes) 1775A, 1775B, 1775C, each of which may be configured to receive an elongated member. In the illustrated variant, positioning openings 1775A and 1775C may be arranged collinearly, and positioning opening 1775B may be slightly offset therefrom. This slight offset of positioning opening 1775B allows the elongated member to pass through each of the positioning openings 1775A to 1775C in a ring configuration, thus limiting the number of contact points between the sutures, which reduces the frictional forces associated with contact with the suture itself. A positioning opening 1779 may be defined in the proximal portion of the first arm 1762 (e.g., the curved portion 1716), which may be configured to receive an elongated member in a manner similar to positioning openings 1775A to 1775C. Positioning openings 1775B and 1779 may be collinear with the longitudinal axis of the first arm 1762 and may be centered relative to the width of the first arm 1762. The placement of positioning openings 1775A to 1775C and positioning opening 1779 allows for the application of a uniform force to the first arm 1762 via a suture passing through it. In some variations, a single elongated member may pass through each of the positioning openings 1775A to 1775C and positioning opening 1779, which allows a user to manipulate the entire first arm 1762. In a further variation, a first elongated member may pass through each of the positioning openings 1775A to 1775C, and a second elongated member may pass through positioning opening 1779. In this variant, the user (e.g., a physician) can individually control the proximal and distal portions of the first arm 1762, allowing the user to adjust the position of the first arm 1762 with increased precision compared to a variant using a single elongated member. Multiple openings defined in the distal portion of the first arm 1762 may include multiple visualization openings, such as visualization openings 1776A and 1776B. Visualization openings 1776A and 1776B may each be configured to receive visualization markers (e.g., radiopaque markers). As previously described, when the implant is in the patient's body, the visualization markers received within visualization openings 1776A and 1776B are indirectly visible to the physician.

[0168] Similar to the first arm 1762, the second arm 1764 may define a plurality of openings in its distal portion, which may be configured to receive one or more elongated members and / or visual markers. The openings defined by the second arm 1764 may then facilitate opening, closing, and / or positioning of the second arm 1764. As shown, a plurality of positioning openings (e.g., suture holes) may be defined in the distal portion of the second arm 1764. The plurality of positioning openings may include positioning openings 1777A, 1777B. Positioning openings 1777A, 1777B may be collinear with respect to each other and may also be collinear with the longitudinal axis of the second arm 1764 and / or the central member 1766. The collinear configuration of positioning openings 1777A, 1777B may facilitate the passage of an elongated member through each of the positioning openings 1777A, 1777B. In this way, the elongated member may form a loop, allowing it to be returned, for example, by a delivery device. Multiple visualization openings, such as visualization openings 1778A and 1778B, may be further defined in the distal portion of the second arm 1764. Visualization opening 1778A may each be configured to receive a visualization marker (e.g., a non-transmissive marker) and may be collinear with the transverse axis of the second arm 1764.

[0169] The first arm 1762 may include a plurality of support members 1781, 1782, 1783, and 1784 extending from a curved portion of the first arm 1762. A central member 1766 may separate the first support member 1781 and the second support member 1782 from the third support member 1783 and the fourth support member 1784. As shown, each of the plurality of support members 1781 to support member 1784 may include a plurality of curves. For example, the first support member 1781 may include a first portion 1781A connected to a second portion 1781B, which may be connected to a third portion 1781C. The first portion 1781A may include a first radius of curvature forming a convex shape. The second portion 1781B may include a second radius of curvature forming a concave shape. The first radius of curvature may be larger than the second radius of curvature. The third portion 1781C may extend along a plane parallel to the plane defined by the first arm 1762. Extending from the third portion 1781C may be a fourth portion 1781D, which may include a curve having a third radius of curvature. A fifth portion 1781E may extend from the fourth portion 1781D. A sixth portion 1781F may extend from the fifth portion 1781E, and the sixth portion 1781F may include a curve having a fourth radius of curvature. The sixth portion 1781F may define a free distal end of the support member 1781. The free distal end of the sixth portion 1781F may be curved toward the central member 1766. The free distal end of the support member 1781 may be blunt so as not to puncture the heart valve tissue. Thus, as described and shown, the support member 1781 may include concave and convex configurations. In some variations, the fourth support member 1784 may be symmetrical with respect to the central member 1766 to the first support member 1781. The fourth support member 1784 may include a first portion 1784A, a second portion 1784B, a third portion 1784C, a fourth portion 1784D, a fifth portion 1784E, and a sixth portion 1784F similar to those of the first support member 1781. The first support member 1781 and the fourth support member 1784 may together define the total width 1732 of the implant 1760. In some variations, the total width 1732 may be between about 10 mm and about 20 mm, about 12 mm and about 20 mm, about 13 mm and about 18 mm, about 14 mm and about 17 mm, or about 15 mm and about 16 mm. For example, in some variations, the total width 1732 may be about 12 mm, about 14 mm, about 15 mm, about 15.5 mm, about 15.8 mm, about 16 mm, or about 17 mm. The second support member 1782 and / or the third support member 1783 may define the total height 1733 of the implant 1760. In some variations, the total height 1733 can be between about 3 mm to about 12 mm, about 4 mm to about 9 mm, about 5 mm to about 8 mm, or about 6 mm to about 8 mm.For example, in some variations, the total height 1733 may be about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 7.2 mm, about 7.5 mm, or about 8 mm. The total width 1732, total height 1733, and length of the joint portion 1704 can be used (e.g., multiplied) to determine the total volume of the joint portion.

[0170] As further shown, the second support member 1782 may include multiple portions 1782A, 1782B, 1782C, and 1782D. The first portion 1782A may include a first radius of curvature, which may be smaller than the first radius of curvature of the first portion 1782A of the first support member 1782. Extending from the first portion 1782A may be a second portion 1782B, which may include a curve having a second radius of curvature. A third portion 1782C may extend from the second portion 1782B and may connect to the fourth portion 1782D. The third portion 1782C may be configured to avoid contact with heart valve tissue. The fourth portion 1782D may include a curve having a third radius of curvature. The third radius of curvature may be similar to (e.g., substantially equal to) the second radius of curvature of the second portion 1782B. A fifth portion 1782E may extend from the fourth portion 1782D. The sixth portion 1782F may extend from the fifth portion 1782E and, similar to the description of 1782F above, may include a curve having a fourth radius of curvature and may define the free distal end of the support member 1782. The free distal end of the support member 1782 may be bent toward the central member 1766 and / or the curved portion 1726. In some variations, the third support member 1783 may be symmetrical about the central member 1766 to the second support member 1782. In some embodiments, the third support member 1783 may include a first portion 1783A, a second portion 1783B, a third portion 1783C, a fourth portion 1783D, a fifth portion 1783E, and a sixth portion 1783F similar to those of the second support member 1782. The second support member 1782 may define a vertex distance 1730 corresponding to the distance between the vertex of the support member 1782 and the vertex of the central member 1766. The apex of the central member 1766 can define a central member height 1734 relative to the plane defined by the planar portion 1714 of the first segment or arm 1762. The central member height 1734 can be between about 1 mm and about 7 mm, about 2 mm and about 6 mm, or about 3 mm and about 5 mm. For example, in some variations, the central member height 1734 can be about 3 mm, about 4 mm, or about 5 mm. Therefore, the apex distance 1730 can be between about 1 mm and about 6 mm, about 2 mm and about 5 mm, or about 2.5 mm and about 3.5 mm. For example, in some variations, the apex distance 1730 can be about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm. Similarly, the third support member 1783 can define an apex distance 1731 corresponding to the distance between the apex of the support member 1783 and the apex of the central member 1766. The apex distance 1731 can be the same as the apex distance 1730. In some variations, such as during the deflection of one or more support members during the engagement of the native leaflets, the vertex distances 1730 and 1731 may be different.Therefore, the vertex distance 1731 can be between about 1 mm to about 6 mm, about 2 mm to about 5 mm, or about 2.5 mm to about 3.5 mm. For example, in some variations, the vertex distance 1730 can be about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm.

[0171] Figures 18A to 18C Front perspective, rear perspective, and bottom perspective views of a first plate configured to be attached to the bottom surface of a first arm of an implant, according to one embodiment, are shown. The first plate 1862 may include a flat portion 1802, a curved portion 1804, a plate extension 1806, a central opening 1863, a plurality of positioning openings 1875A to 1875C, a positioning opening 1879, and friction elements 1872, 1873. The flat portion 1802 and the curved portion 1804 may each include shapes corresponding to corresponding portions of the first arm described herein. The flat portion 1802 may define one or more openings, such as positioning openings 1875A to 1875C, and the curved portion 1804 may also define one or more openings, such as positioning opening 1879. As described above, the positioning openings 1875A to 1875C and 1879 of the first plate 1862 may correspond to the positioning openings of the first arm, allowing an elongated member to pass through one or more positioning openings 1875A to 1875C and 1879 to facilitate opening and / or closing of the implant. The intermediate opening 1863 may be inserted into each of the flat portion 1802 and the curved portion 1804. The intermediate opening 1863 may include dimensions and shapes corresponding to the size and shape of the second arm (not shown), allowing the second arm to be accommodated therein. For example, the opening 1863 may be sized such that the second arm can pass through the opening 1863 without contacting the first plate 1862.

[0172] Extending from the curved portion 1804 may be a plate extension 1806, which may be configured to contact and / or apply compressive force to the heart valve tissue. While the planar portion 1802 and the curved portion 1804 may contact the first arm, the plate extension 1806 may not contact the first arm (e.g., the plate extension 1806 may extend away from the first arm). Due to the protruding configuration of the plate extension 1806, the plate extension 1806 can advantageously apply compressive force. The plate extension 1806 may include a smaller width than the planar portion 1802 and / or the curved portion 1804, which may contribute to the elastic deformability of the plate extension 1806. In some variations, the width of the plate extension 1806 may allow the plate extension 1806 to be positioned between (e.g., not in contact with) the friction elements of the second segment or arm or the second plate. Therefore, the width of the plate extension 1806 can be between about 0.5 mm and about 3 mm, about 0.5 mm and about 2 mm, about 1 mm and about 2 mm, or about 1 mm and about 1.5 mm. For example, in some variations, the width of the plate extension 306 can be about 0.5 mm, about 1 mm, about 1.2 mm, or about 1.5 mm.

[0173] The plate may include friction elements, as previously described, configured to apply frictional force to heart valve tissue. As shown, the first plate 1862 may include a first set of friction elements 1872 along two edges of a flat portion 1802 and a second set of friction elements 1873 along two edges of a plate extension 1806. The first set of friction elements 1872 may define a first angle relative to the tissue-facing surface of the flat portion 1802, and the second set of friction elements 1873 may define a second angle relative to the tissue-facing surface of the plate extension 1806. The first and second angles may be different, which may facilitate easier disengagement of the friction elements 1872, 1873 from the tissue, allowing the implant, as described herein, to be non-destructively removed from a first location of the heart valve (e.g., the first native valve leaflet) and moved to a second location of the heart valve. In a further variation, the first and second angles may be the same, which may facilitate faster and / or easier manufacturing.

[0174] Figures 19A to 19CA front view, a side view, and a bottom view of a second plate 1964 configured to be coupled to the top surface of a second arm of an implant according to an embodiment are shown. The second plate 1964 may include a flat portion 1902, a curved portion 1904, a plurality of positioning openings 1977A, 1977B, and a plurality of friction elements 1974. The flat portion 1902 and the curved portion 1904 may each include a shape corresponding to the second arm described herein. Similar to the first plate 1862, the second plate 1964 may define one or more openings, such as positioning openings 1977A, 1977B. Positioning openings 1977A, 1977B may correspond to positioning openings of the second arm, such that an elongated member can pass through one or more positioning openings 1977A, 1977B to facilitate opening and / or closing of the implant. The plurality of friction elements 1974 may define a third angle relative to the tissue-facing surface of the second plate 1964. The third angle may be the same as or different from the first or second angle associated with the plurality of friction elements 1872, 1873. The first, second, or third angle may be adjusted during the manufacturing phase or by a physician before the implant is inserted into the patient.

[0175] Figure 20AAn exemplary embodiment of attaching a first plate to a first arm and a second plate to a second arm is shown. The implant 2060 shown may be made of metal (e.g., nitinol), so these components are well-suited for welding. As shown, the first plate may be attached to the first arm via multiple welds, such as along a first weld 2040 and a second weld 2042. The first weld 2040 may extend along a portion of the outer periphery of each of the first arm and the first plate, and the second weld 2042 may extend along a portion of the inner periphery of each of the first arm and the first plate. The lengths of welds 2040 and 2042 may be sufficient to withstand any forces associated with the surgical procedure, implantation process, and / or cardiac events described herein. Thus, the length of weld 2040 may be between about 2 mm and about 15 mm, about 4 mm and about 12 mm, or about 5 mm and about 8 mm. For example, in some variations, the length of weld 2040 may be about 2 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, or about 8 mm. The length of weld 2042 can be between about 3 mm and about 15 mm, about 4 mm and about 13 mm, about 5 mm and about 12 mm, or about 6 mm and about 10 mm. For example, in some variations, the length of weld 2042 can be about 4 mm, about 6 mm, about 8 mm, about 10 mm, or about 12 mm. Additionally or alternatively, the second plate can be joined to the second arm via multiple welds, such as along a third weld 2044 and a fourth weld 2046. The third weld 2044 can extend along a portion of the outer periphery of each of the second plate and the second arm, and the fourth weld 2046 can extend along the entire periphery of an opening (e.g., a suture hole) defined by each of the second arm and the second plate. Therefore, the length of weld 2044 can be between about 3 mm and about 15 mm, about 4 mm and about 12 mm, or about 5 mm and about 10 mm. For example, in some variations, the length of weld 2044 can be about 4 mm, about 6 mm, about 8 mm, or about 10 mm. The length of weld 2046 can be between about 0.5 mm and about 5 mm, about 1 mm and about 5 mm, or about 1 mm and about 3 mm. For example, in some variations, the length of weld 2046 can be about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, or about 5 mm.

[0176] Figures 21A to 21BAn exemplary variant of a visual marker (e.g., a non-transparent marker) received within a visual opening (e.g., a non-transparent opening) of a first arm 2162 is shown. The first arm 2162 may include a first visual opening 2179A configured to receive a first visual marker 2185A and a second visual opening 2179B configured to receive a second visual marker 2185B. The visual openings 2179A and 2179B may include a substantially circular shape, and the visual markers 2185A and 2185B may have a similar shape. In some variants, the visual markers 2185A and 2185B may include a diameter slightly smaller than the diameter of the respective visual openings 2179A and 2179B, such that the visual markers 2185A and 2185B can be securely coupled to the respective visual openings 2179A and 2179B by friction (e.g., via friction engagement). In other variations, the visual markers 2185A and 2185B may include diameters smaller than the corresponding visual openings 2179A and 2179B, making friction-fit techniques impossible. Therefore, an adhesive may be placed below, around, and / or on top of the visual markers 2185A and 2185B to securely attach the radiopaque markers to the radiopaque openings. In either case, the visual markers 2185A and 2185B can be securely fastened in place using, for example, adhesives and / or welding. The illustrated visual markers 2185A and 2185B may be made of a metal (e.g., platinum) and can therefore be welded in place along the first marker weld 2148A and the second marker weld 2148B. The lengths of the marker welds 2148A and 2148B may correspond to the entire circumference of the corresponding visual openings 2179A and 2179B. In some variations, the length of the marker weld may correspond only to a portion of the circumference of the corresponding visual opening (e.g., via spot welding). Visual markers can be attached to the visual openings of the second arm in a similar manner.

[0177] Figure 22A A cover for an implant for treating valvular regurgitation according to an embodiment is illustrated. The cover 2268 may be configured to cover portions of attachment parts, such as portions of the first arm, central member, and second arm as described herein. For example, the cover 2268 may include a first portion 2292 configured to cover a portion of the first arm, and a second portion 2296 configured to cover portions of the central member and second arm. As shown, the first portion 2292 may include a width greater than the second portion 2296, which may correspond to a greater width of the first arm relative to the second arm and / or the central member. Also as shown, the second portion 2296 may include a length greater than the first portion 2292, which may correspond to a combined length of the portions of the central member and second arm relative to the first arm. Figures 22B to 22CAn alternative view of the cover 2268 attached to the implant is shown. As shown, portion 2296 may cover most of the second arm and the central member, and may extend through the opening defined by the first arm 2262. Portion 2292 may cover most of the first arm, while leaving the support members 2281, 2282, 2283, and 2284 extending from the first arm uncovered. Portions 2292 and 2296 may similarly leave uncovered friction elements extending from each of the first and second arms. Cover 2268 may be securely attached to the implant via multiple sutures along the periphery of cover 2268.

[0178] Figure 23A A top view of the cover in a flat configuration according to an embodiment is shown. Figures 23B to 23C A front view of a cover attached to an implant according to an embodiment is shown. As shown, the cover 2368 can be coupled with... Figures 22A to 22C The cover 2268 shown is used in combination. The cover 2368 may be configured to cover a portion of the support member and extend beyond the implant. For example, the cover 2368 may include a first portion 2392A and a second portion 2392B that commonly define a channel 2395. The first portion 2392A may be configured to cover a portion of the support member on a first side of the central member, and the second portion 2392B may be configured to cover a portion of the support member on a second side of the central member. The channel 2395 may be configured to receive the central member, which may already be covered by the cover 2268. The cover 2368 may further include a third portion 2394, which may be configured to cover another portion of the support member on both sides of the central member. In this way, the third portion 2394 may be coupled to each of the first portion 2392A and the second portion 2392B, such that the support member is covered therebetween. The cover 2368 may further include a fourth portion 2396, which may be initially formed as a rectangle before being rolled into a cylinder and partially attached to other portions of the cover 2368. For example, the fourth portion 2396 may be attached to the third portion 2394 via one or more sutures and / or adhesive. In this way, the fourth portion 2396 may extend beyond the implant body, which can increase the surface area of ​​the engagement portion to provide a larger surface area for engagement. The increased surface area for engagement can be beneficial for the use of the implant in patients with clinical conditions associated with a relatively large gap between the leaflets (e.g., valvular regurgitation).

[0179] Figure 24 The embodiment shown is in a substantially flat configuration. Figures 17A to 17GThe image shows a front view of the implant. The flat configuration of the implant body can be achieved by cutting the outline of the implant from a flat sheet. As shown, the implant body 2460, shown in a flat configuration, may include a first arm 2462, a central member 2466, and a second arm 2464. The first arm 2462 may extend from or be otherwise connected to a first end of the central member 2466, and the second arm 2464 may extend from or be otherwise connected to a second end of the central member 2466 opposite to the first end. The first arm 2462 may define a plurality of openings, such as positioning openings 2475A, 2475B, and 2475C, each configured to receive an elongated member (e.g., a suture), similar to... Figures 17A to 17G The description. The multiple openings in the distal portion of the first arm 2462 may also include multiple visual openings, such as visual openings 2476A and 2476B. (See previous reference...) Figures 17A to 17G As described, visualization openings 2476A and 2476B can be configured to receive visualization markers. The first arm 2462 can further define an intermediate opening 2463, which can be configured to receive a portion of the second arm 2464. The central opening 2463 can be further configured to receive a portion of a cover, such as the previously described covers 2268 and 2368. A positioning opening 2479 can be defined in the proximal portion of the first arm 2462, which can be configured to receive an elongated member in a manner similar to positioning openings 2475A to 2475C.

[0180] Extending from the first arm 2462 may be multiple support members, such as support members 2481, 2482, 2483, and 2484. Support members 2481 and 2482 may be separated from support members 2483 and 2484 by a central member 2466. In some variations, support members 2481 and 2482 may be symmetrical with respect to the longitudinal axis of the first arm 2462 and / or the central member 2466 with respect to support members 2483 and 2484. Therefore, support members 2481 and 2484 may each include a first length and support members 2482 and 2483 may each include a second length. The first length may be greater than the second length. Support members 2481 to 2484 may include a thickness equal to the remainder of the implant body and may each include a width of about 100 micrometers to about 200 micrometers (such as about 150 micrometers). This width can promote the flexibility of the support member described herein by reducing the mechanical stress generated at the connection point between the support member and the first arm 2462.

[0181] Reference Figures 17A to 17GSimilar to the description provided, the second arm 2464 may include multiple openings to facilitate opening, closing, and / or positioning of the second arm 2464. As shown, multiple positioning openings may be defined in the distal portion of the second arm 2464 (relative to the physician during implantation, when the implant body can be in a closed configuration). The multiple positioning openings may include positioning openings 2477A, ​​2477B. Multiple radiopaque openings, such as visualization openings 2478A, 2478B, may be further defined in the distal portion of the second arm 2464. Visualization openings 2478A, 2478B may each be configured to receive a visualization marker, similar to the previously provided description.

[0182] Figure 25 and Figure 26 Exemplary variations of a first plate 2562 and a second plate 2564 in a planar configuration are shown, respectively, which are configured to be connected to the body described herein. The first plate 2562 can be manipulated to... Figures 18A to 18C The configuration is shown. Therefore, the descriptions of positioning openings 2575A, 2575B, 2575C, and 2579 correspond to positioning openings 1875A, 1875B, 1875C, and 1879. Plate 1862 may further include a plurality of slots 2572, each of which may be adjacent to friction elements 1872 and 1873 (not shown). Each slot 2572 may define a length corresponding to the height of friction elements 1872 and 1873, and may facilitate the placement of friction elements 1872 and 1873 (not shown). Figures 18A to 18C (As shown) bends to a desired angle corresponding to the desired frictional force. Each slot 2572 may terminate at a circular portion 2572A. The circular portion 2572A may be configured to reduce and cause the friction element 1872 ( Figures 18A to 18C (As shown) the mechanical stress associated with bending. The second plate 2664 can be manipulated to... Figures 19A to 19C The configuration is shown. The second plate 2664 may include a plurality of positioning openings 2677A, 2677B, which may correspond to positioning openings 1977A, 1977B. The second plate 2664 may further include a slot 2674 and a circular portion 2674A, the slot and the circular portion functioning similarly to those in the reference design. Figure 25 The first plate 2562 describes the slot 2572 and the circular portion 2572A. Plates 2562 and 2564 can then be attached to the implant body, as previously referenced. Figures 20A to 20E Described.

[0183] Figure 27AThis is a front view of an implant 2760 according to an embodiment. The implant 2760 may include an attachment portion and an engagement portion as previously described herein. The attachment portion may include a first portion of a first segment or arm 2762 and a first portion of a second segment or arm 2764. The engagement portion may include a second portion of the second segment or arm 2764 and a central member 2766. The first arm 2762 may include one or more positioning openings 2775A, 2775B, 2775C (e.g., three positioning openings) disposed at its distal end, and the second arm 2764 may include one or more positioning openings 2777A, 2777B (e.g., two positioning openings) disposed at its distal end. The first arm 2762 may further include one or more visual marker openings 2776A, 2776B disposed distal to the positioning openings 2775A, 2775B, 2775C, as previously described herein. Each of the first arm 2762 and the second arm 2764 may further include a friction element 2770, as previously described herein. The first arm may further include a proximal positioning opening 2779. The implant may further include a first support member 2780A, a second support member 2780B, a third support member 2780C, and a fourth support member 2780D. Implant 2760 may be structurally and / or functionally similar to any of the implants described herein (e.g., implant 460, implant 1660, etc.), and therefore is not referred to. Figures 27A to 27B Further details of implant 2760 are described below. Implant 2760 may be similar to... Figure 15 To implants 1560 and 1660 in Figure 16; however, implant 2760 may include a teardrop shape 2771 at the end of each tooth or friction element 2770 to reduce stress concentration when they are bent, such as Figure 27B As shown.

[0184] Figure 28 Images show various implant dimensions (e.g., 10 mm on the left, 12 mm in the middle, and 16 mm on the right) in delivery configurations (bottom row) and unfolded configurations (top row). In the delivery configuration, the implant is in a constrained state, where the support members of the implant are elongated, causing the implant to fit within the lumen of the implant catheter. In some embodiments, in the constrained state, the support members of the implant are configured to fold over each other to reduce the overall width (or cross-sectional area) of the implant, causing the implant to fit within the lumen of the implant catheter. The free ends of the support members allow them to fold over each other to transition the implant to the constrained state. In some embodiments, the support members of the implant can extend in the constrained state to reduce the overall width of the implant. When the implant unfolds (e.g., is advanced out of the implant catheter), the implant catheter no longer constrains the implant, and the implant returns to its relaxed state, in which the support members extend away from the central member of the implant. Although in Figure 28 In this design, the implant is shown directly in the implant catheter; however, it should be understood that the implant may be coupled to an implant retainer and transition between a constrained and relaxed state while coupled to the implant retainer. Additionally, the implant may include a cover disposed above the support member and configured to conform to the support member when the implant transitions between the constrained and relaxed states.

[0185] Figures 29A to 29F and Figure 31 The figures and flowcharts illustrate a method for reducing valvular regurgitation using an implant. This method is applicable to any implant delivery system and implant described herein. As shown, method 3100 may optionally include selecting an implant from a plurality of implants 3108. For example, multiple implants corresponding to various potential patients may be available, and the physician may select an implant sized to fit patient parameters (e.g., age, sex, heart valve type, heart valve size, regurgitation severity, etc.). As previously described, the implant may be releasably coupled to a delivery device (e.g., implant retainer) in a delivery configuration. Method 3100 may further include advancing the implant in the delivery configuration to the heart valve at 3110 using an implant delivery system, such as... Figure 29A As can be seen in the image. Heart valves may include the mitral valve, tricuspid valve, aortic valve, pulmonary valve, or portions thereof (e.g., leaflets, chordae tendineae, annulus). As shown in the figure, the distal end of the implant delivery system passes through the mitral valve from the atrium into the ventricle. Figure 29B As shown. Once positioned near the valve, the first and second arms of the implant can be separated at 3112. The first and second arms can be separated using one or more elongated members extending through the implant delivery system and the corresponding portions (e.g., one or more arms) of the implant. For example, a physician can manipulate an actuator of the implant delivery system (e.g., press a button, pull a trigger) to apply a pulling force (e.g., pull a suture) to one or more elongated members. One or more elongated members can be coupled to the first and / or second arms such that the applied pulling force overcomes the biasing force of a central member connected to each of the first and second arms. The tension is sufficient to achieve a separation angle such that the implant can receive heart valve tissue between the first and second arms. At 3120, the first arm can be positioned on a first side of the heart valve and the second arm can be positioned on a second side of the heart valve, as shown. Figures 29C to 29D As shown. In some variations, the first segment or arm may be attached to the leaflet surface on the first side, such as the atrial surface of the mitral valve leaflet. The second segment or arm may be attached to the leaflet surface on the second side, such as the ventricular surface of the mitral valve leaflet. In further variations, the first segment or arm and the second segment or arm may each be attached to the side of the tricuspid valve, aortic valve, and / or pulmonary valve.

[0186] In some embodiments, visual markers on the first and second arms can be used to determine the position of the first and second arms relative to each other. For example, at least one visual marker (e.g., a radiopaque marker) may be attached to each of the first and second arms, allowing the physician to indirectly observe the configuration of the implant (e.g., open or closed configuration) via an appropriate imaging modality.

[0187] When it is determined that the placement of the implant is acceptable, at 3130 at least one of the first and second arms may be released to engage the implant with one or more of the native leaflets and chordae tendineae of the heart valve. The implant may be engaged with the heart valve tissue via (i) compressive forces generated by the central member and applied by the first and second arms and / or (ii) frictional forces generated by its frictional elements. In some variations, the compressive and / or frictional forces may correspond to pull-out forces. Pull-out forces may include forces required to move the implant without first separating the first segment or arm and the second segment or arm (e.g., a pulling force acting along the longitudinal dimension of the implant). Unintended movement of the implant (e.g., movement without first separating the first segment or arm and the second segment or arm) when the implant applies one or more of the compressive and frictional forces to the heart valve tissue may be referred to as dehiscence. In some variations, the compressive and frictional forces can be several times greater than the pull force, either individually or in combination, such as from about 2 to about 100 times, including about 5 times, about 10 times, about 20 times, about 30 times, about 40 times, or about 50 times.

[0188] At 3140, the implant may optionally be repositioned relative to the heart valve. Repositioning the implant may include dissociating a first arm and a second arm, which can be achieved by applying a pulling force to one or more elongated members passing through one or more of the first and second arms. Dissociating the arms may non-destructively (e.g., without damage) separate the arms (including friction elements) from the heart valve tissue, allowing the implant to move without scratching or otherwise damaging the heart valve tissue. The implant can then be moved to a second location, which can be observed and / or confirmed via previously described visual markers. The second location may be at a different location on the same heart valve to which the implant was previously attached, or, in some variations, at a location on different heart valves. With the arms still dissociated, the implant may receive the heart valve tissue associated with the second location. The arms may then be released to reattach the implant to the heart valve. Reattaching the implant may include applying the same or similar frictional and compressive forces applied during the initial attachment. The implant may be repeatedly repositioned until it is properly positioned to effectively treat heart conditions such as valvular regurgitation. The elongated component passing through the implant can be cut or otherwise detached from the implant, allowing the elongated component and / or delivery device to be retracted from the patient's body, such as... Figure 29EAs can be seen in the image. Optionally, in some variations, valve replacement surgery (e.g., transcatheter mitral valve replacement) can be performed on the same heart valve connected by the implant. For example, valve replacement surgery can be performed on the same heart valve connected by the implant without removing the connected implant before, during, or after the surgery.

[0189] In further variations, more than one implant can be attached to the heart valve, such as... Figure 29F As shown. For example, a first implant may be attached to A1, a second implant to P2, and a third implant to A3. Treatment can be performed on more than one site to maximize the effectiveness of the implants described herein. That is, multiple implants may be required to effectively reduce valvular regurgitation. Multiple implants can be inserted during the same surgical procedure, allowing the same delivery device to be advanced to insert the implant, retract, and subsequently advanced to insert an additional implant, or they can be inserted during different surgical procedures. In some variations, the implant can optionally be removed from the heart valve at 3150. Similar to the steps described previously, the first and second arms can be separated via tension applied to one or more elongated members passing through one or more of the first and second arms. The implant can then be reattached to the delivery device, allowing both the delivery device and the implant to be removed from the patient's body.

[0190] Figures 30A to 30D This document illustrates a method for delivering an implant to a heart valve to treat valvular regurgitation using an implant delivery system according to an embodiment. This method is applicable to any implant delivery system and implant described herein. The distal end of a guiding catheter is advanced through the inferior vena cava into the right atrium and across the interatrial septum into the left atrium, as described above. Figure 30A As shown. The delivery catheter and the implantation catheter, including the implant connected thereto, can be advanced through the guiding catheter and further into the left atrium (e.g., approximately 2 cm), as... Figure 30B As shown. The mitral valve manipulation delivery catheter and implant catheter, as... Figure 30C As shown. Figure 30D As shown, the implant catheter can be advanced further distally to position the implant relative to the leaflets of the mitral valve. The implant can then be placed around a portion of the leaflets of the mitral valve, and the effectiveness of the implant for treating valvular regurgitation can be tested before the implant is fully deployed and the catheter is removed from the heart.

[0191] Figure 32This is a flowchart illustrating an example method for delivering an implant to reduce valvular regurgitation according to an embodiment. This method is applicable to any implant delivery system and implant described herein. The method includes, at 3210, inserting a manipulable guide catheter having an implant catheter slidably and rotatably disposed therein through the patient's vascular system such that the distal end of the guide catheter is positioned in the atrium of the heart, with the implant in its closed position and detachably coupled to the distal portion of the implant catheter during insertion. At 3220, with the guide catheter positioned in the atrium, the implant catheter may be advanced relative to the guide catheter to expose the implant from the guide catheter within the atrium. Then, at 3230, the implant may be changed from the closed position to the open position. At 3240, method 3200 may optionally include rotating and / or manipulating (or deflecting) the implant catheter relative to the guide catheter to align the implant with the native valve leaflet. At 3250, the implant may be aligned in its open position to position the free end of the native valve leaflet within the space defined by the implant. For example, the implant can be opened so that a portion of the heart tissue is positioned between a pair of arms of the implant. At 3260, with the free end of the native leaflet positioned within the space defined by the implant, the implant can be changed from an open position to a closed position to clamp the free end of the native leaflet between the pair of arms. At 3270, with the implant clamped to the native leaflet, the implant catheter and the guiding catheter can be withdrawn from the patient. In some embodiments, withdrawing the guiding catheter from the patient includes separating the elongated components (e.g., the atrial and ventricular tethers) from the implant by pulling the atrial and ventricular tethers from the proximal end of the implant delivery system. For example, the distal portion of each of the atrial and ventricular tethers near the implant delivery system can be cut or untied, and each of the atrial and ventricular tethers can be pulled proximally from the proximal end of the implant delivery system. In some embodiments, the implant catheter can be withdrawn proximally into the lumen of the guiding catheter, and the guiding catheter in which the implant catheter is disposed can be withdrawn from the heart.

[0192] Figure 33This is a flowchart of an example method for manufacturing an implant according to an embodiment. As shown, an implant, including the implant body and plate described herein, can be cut from a substantially flat sheet and subsequently folded, rolled, and / or bent into a three-dimensional shape 3410. The initial flat configuration of the implant can facilitate faster and more economical manufacturing. For example, the substantially flat sheet can be cut via laser cutting, waterjet cutting, plasma cutting, and / or handheld tin shears according to a predetermined design of the implant. The predetermined design of the implant may correspond to parameters associated with a potential patient. Thus, multiple designs corresponding to various patients can be generated. The cut-out implant body, which may still be flat, can then be further processed via, for example, grinding, brushing, and / or deburring to eliminate any sharp edges 3420. Eliminating sharp edges can prevent tissue damage during advancement to the treatment location or otherwise placing the implant at the treatment location and / or attaching the implant to heart valve tissue. The still flat cut can then be set into a predetermined multi-dimensional configuration (e.g., a first configuration) 3430 as described above. In some embodiments, the implant body may be heat-treated for shaping. The flat sheet may include a thickness that facilitates the manufacturing steps (e.g., cutting, bending), such as about 50 micrometers to about 500 micrometers (inclusive of all values ​​and subranges therein). In some variations, the flat sheet may have a thickness of about 250 micrometers. Furthermore, the material used to form the implant body may be a flexible material to facilitate the performance of the manufacturing steps. For example, the material may be a metal (e.g., nitinol, titanium, aluminum, gold, silver, and their alloys) or a plastic (e.g., polypropylene, polyvinyl chloride, polyethylene, polyurethane). The material may be further determined by its shape setting, shape memory, and / or hyperelastic properties. For example, the implant described herein may be able to return to a predetermined configuration after elastic deformation. In this way, the implant can advantageously return to a desired shape after release from the delivery device or, for example, after impact from the native leaflet. In some embodiments, at 3440, the first plate and the second plate may be configured in a predetermined configuration. In some variations, the first plate may be attached to a first arm of the implant body 3450. Similarly, the second plate may be attached to a second arm of the implant body 3460. In some variations, at least one visual marker may be attached to the first arm (e.g., via welding) 3470. Similarly, at least one visual marker may be attached to the second arm (e.g., via welding) 3480. Then, at least one cover may be attached to the implant body 3490. In some variations, the first cover may be coupled to the first arm, the second arm, and / or the central member, and the second cover may be coupled to a support member extending from the first arm.

[0193] Example

[0194] The following examples are provided to illustrate the claimed invention, but are not intended to limit it.

[0195] Example 1: Pull-out force

[0196] The device described herein was coupled to the anterior or posterior leaflets of five porcine mitral valves to assess the force required for dehiscence and / or pull-out. Dehiscence was defined as movement of the implant at least 2 mm from its implantation site. Pull-out was defined as complete removal of the implant from the leaflet. Weights were suspended from the implant using non-extensible sutures in progressively increasing increments until dehiscence and / or pull-out occurred. The average weight of the implant at 2 mm movement from its implantation site was 500 g, equivalent to a force of 4.9 N. None of the tested configurations resulted in implant pull-out. Therefore, the force required to remove the implant is significantly higher than the actual physiological conditions the implant might experience.

[0197] Example 2: Compression force

[0198] The device described herein was tested to measure the compressive forces applied to the mitral valve tissue by two segments or arms. A custom-designed weighing sensor device was used to measure the compressive forces exerted by the implant on native mitral valve leaflets of varying thicknesses. The implant applied a minimum compressive force of 200 mN, which increased linearly with leaflet thickness. The measured forces were 40 times greater than the calculated forces associated with dehiscence when theoretical calculations were performed on the hemodynamics exerted by blood flow and mitral valve pressure. Therefore, the compressive forces exerted by the implant on the native mitral valve were sufficient for secure attachment without any dehiscence.

[0199] Example 3: Patient Group

[0200] Three clinically relevant valvular pathologies were investigated: atrial FMR (aFMR), where the primary contributing factor to loss of valve engagement is severe annular dilation (seen in patients with chronic atrial fibrillation); ischemic FMR (iFMR), where contributing factors to loss of valve engagement are annular dilation and focal displacement of the posteromedial papillary muscles due to underlying posterolateral or inferior myocardial infarction; and dilated cardiomyopathy FMR (dFMR), where contributing factors to loss of valve engagement are annular dilation and bilateral papillary muscle displacement due to concentric dilation of the left ventricle due to various etiologies. A left ventricular simulator was used. A porcine mitral valve was fitted into the simulator, the annulus was fitted into a dilatational system, and the papillary muscles were fitted into a system allowing for spatial displacement / repositioning. aFMR, iFMR, or dFMR was then induced using the simulator. Mitral hemodynamics were measured using a calibrated pressure sensor, and flow rate was measured using a calibrated electromagnetic flow probe. At baseline (i.e., a healthy / disease-free valve), the regurgitation fraction was 0%. When the implant was deployed onto a healthy / disease-free valve, the regurgitation fraction was 1.03 ± 0.86%, which was negligible. In the atrial FMR state (aFMR), a significant increase in the regurgitation fraction due to annular dilation was observed, at 14.78 ± 3.10%. With implant deployment, aFMR significantly decreased to 6.79 ± 1.89% (p = 0.001). In the ischemic FMR state (iFMR), the pre-repair regurgitation fraction was 20.52 ± 2%, and after implantation, the regurgitation fraction decreased to 6.63 ± 2.15% (p < 0.0001). In the dilated cardiomyopathy FMR state (dFMR), the pre-repair regurgitation fraction was 21.93 ± 7.2%, which significantly decreased to 7.12 ± 2.8% after implantation. The results are illustrated in Figure 16. Therefore, quantitative measurements of mitral regurgitation in different clinically relevant anatomical states leading to FMR indicate that the implant can be very effective in treating aFMR, iFMR, and dFMR.

[0201] Although various embodiments of the invention have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for performing the functions described herein and / or obtaining these results and / or one or more of these advantages, and each such variation and / or modification is considered to be within the scope of the embodiments of the invention described herein. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications and anatomical structures (e.g., intracranial and extracranial vascular structures) using the teachings of this invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments of the invention described herein using only conventional experiments. Therefore, it should be understood that the foregoing embodiments are presented by way of example only and within the scope of the appended claims and their equivalents; embodiments of the invention may be practiced in ways different from those specifically described and claimed. The embodiments of the invention disclosed herein relate to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits and / or methods is included within the scope of this disclosure if such features, systems, articles, materials, kits and / or methods do not contradict each other.

[0202] Various inventive concepts can be implemented as one or more methods, with at least one instance provided. Actions performed as part of a method can be ordered in any suitable manner. Thus, embodiments can be constructed in which actions are performed in a different order than those shown, which may include performing several actions simultaneously, even if the actions are shown as sequential in the illustrative embodiments.

[0203] As used herein, the terms “about” and / or “approximately” when used in conjunction with numerical values ​​and / or ranges generally refer to those values ​​and / or ranges that are close to the listed values ​​and / or ranges. In some cases, the terms “about” and “approximately” may refer to within ±10% of the listed values. For example, in some cases, “about 100 [units]” may refer to within ±10% of 100 (e.g., from 90 to 110). The terms “about” and “approximately” are used interchangeably.

[0204] Any and all references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., presented anywhere in this application, are incorporated herein by reference in their entirety. Furthermore, all definitions defined and used herein should be understood as controls over dictionary definitions, definitions in documents incorporated by reference, and / or the general meaning of the defined terms.

[0205] The specific examples and descriptions herein are exemplary in nature, and those skilled in the art can develop embodiments based on the materials taught herein without departing from the scope of the invention.

Claims

1. An implant for reducing valvular regurgitation, said implant comprising: The attachment portion includes at least a first portion of a first arm and a second arm, the first arm and the second arm being configured to attach the implant to a first native leaflet; as well as The joining portion is configured to provide a contact surface for the second primary leaflet. The joining portion includes a plurality of support members, each of which extends from the first arm to a corresponding free end.

2. The implant of claim 1, wherein the second portion of the second arm forms part of the engagement portion.

3. The implant of claim 1, wherein the engagement portion is further configured to receive at least a portion of the first native leaflet.

4. The implant of claim 1, wherein the maximum width of the first arm is about 1.05 to about 1.75 times the maximum width of the second arm.

5. The implant of claim 1, wherein the length of the first arm is about 1.05 to about 1.5 times the length of the second arm.

6. The implant of claim 1, wherein the first arm includes a first planar portion and the second arm includes a second planar portion.

7. The implant of claim 6, wherein each of the first planar portion and the second planar portion is configured to contact the first native leaflet.

8. The implant of claim 6, wherein the first planar portion and the second planar portion are configured to be coplanar in a first configuration.

9. The implant of claim 8, wherein in the first configuration, the distal end of the first arm extends distally beyond the distal end of the second arm.

10. The implant of claim 1, wherein the length of the implant is between about 50% and about 100% of the length of the first native leaflet.

11. The implant of claim 1, wherein the length of the second arm is between about 25% and about 75% of the length of the implant.

12. The implant of claim 1, wherein the first arm is configured to connect to the atrial surface of the original leaflet, and the second arm is configured to connect to the ventricular surface of the first original leaflet.

13. The implant of claim 1, wherein the plurality of support members comprises support members of two to six.

14. The implant of claim 13, wherein the plurality of support members comprises four support members.

15. The implant of claim 1, wherein a portion of at least one of the plurality of support members is configured to contact the first native leaflet.

16. The implant of claim 1, wherein at least one of the plurality of support members is configured to avoid contact with the first native leaflet.

17. The implant of claim 1, wherein each of the plurality of support members is configured to temporarily deform for placement within the delivery device.

18. The implant of claim 1, wherein a portion of the first support member of the plurality of support members is configured to contact the first native leaflet, and a second support member of the plurality of support members is configured to avoid contact with the first native leaflet.

19. The implant of claim 1, wherein at least one of the plurality of support members is configured to be deflected by the second native leaflet.

20. The implant of claim 1, wherein at least one of the support members has a first portion having a convex shape and a second portion having a concave shape.

21. The implant of claim 1, wherein a portion of the first support member is parallel to the plane defined by the first arm.

22. The implant of claim 1, wherein the support member of the plurality of support members is symmetrical about the longitudinal axis of the first arm.

23. The implant of claim 1, wherein the engagement portion further comprises a central member connecting the first arm to the second arm.

24. The implant of claim 23, wherein the central member is configured to bias the first arm toward the second arm.

25. The implant of claim 23, wherein the free end of at least one of the plurality of support members is bent toward the central member.

26. The implant of claim 23, wherein the free end of each of the plurality of support members is bent toward the central member.

27. The implant of claim 23, wherein the engagement portion further comprises a cover disposed above the plurality of support members and the central member.

28. The implant of claim 1, wherein the first arm and the second arm can be separated by applying a separation force of about 150 mN to about 600 mN to the first arm and the second arm.

29. The implant of claim 1, wherein each of the first arm and the second arm includes an opening configured to receive a radiopaque marker.

30. The implant of claim 1, wherein one or more of the first arm and the second arm includes a plurality of openings, each opening being configured to receive a radiopaque marker.

31. The implant of claim 1, wherein one or more of the first arm and the second arm includes a plurality of openings, each opening being configured to receive sutures.

32. A system comprising: The implant according to claim 1; as well as A delivery device that is releasably coupled to the implant.

33. An implant for reducing valvular regurgitation, said implant comprising: A central component, the central component having a first end and a second end; A first arm extends from the first end of the central member; The second arm extends from the second end of the central member; as well as Multiple support members, each extending from the first arm to a corresponding free end.

34. The implant of claim 33, wherein the central member is curved.

35. The implant of claim 33, wherein the free end of each of the plurality of support members is coplanar with the proximal surface of the central member.

36. The implant of claim 33, wherein the radius of curvature of the central member is smaller than the radius of curvature of each of the plurality of support members.

37. The implant of claim 33, wherein the central member forms at least a portion of the engagement portion.

38. The implant of claim 33, wherein the central member is configured to bias the first arm toward the second arm.

39. An implant for reducing valvular regurgitation, said implant comprising: The joining portion is configured to receive a first native leaflet; as well as The attachment portion includes a first arm and a second arm configured to connect the implant to the first native leaflet. The implant further includes a first set of friction elements and a second set of friction elements extending from the first arm at a first angle and a second angle, respectively, wherein the first angle is different from the second angle.

40. The implant of claim 39, further comprising a first plate coupled to the first arm, wherein the first set of friction elements and the second set of friction elements are integrally formed with the plate.

41. The implant of claim 39, wherein the first set of friction elements and the second set of friction elements are integrally formed with the first arm.

42. The implant of claim 40, wherein the implant further comprises a second plate coupled to the second arm and including a third set of friction elements, the second plate comprising a first portion having a first width and a second portion having a second width greater than the first width.

43. The implant of claim 40, wherein the first plate includes a plurality of slots, each slot adjacent to a corresponding friction element, wherein each slot terminates at a circular portion.

44. The implant of claim 42, wherein each of the first arm, the second arm, the first plate, and the second plate includes a plurality of suture holes, each suture hole being configured to receive sutures.

45. The implant of claim 42, wherein each of the first arm and the second arm includes an opening configured to receive a radiopaque marker.

46. ​​The implant of claim 45, wherein the first plate is configured to cover a portion of the opening in the first arm, and the second plate is configured to cover a portion of the opening in the second arm.

47. An implant for reducing valvular regurgitation, said implant comprising: The attachment portion is configured to connect the implant to the first native leaflet; as well as The joining portion, wherein the joining portion is configured such that the second primary leaflet provides a contact surface and / or closes at least the gap between the first primary leaflet and the second primary leaflet, the joining portion comprising: The first part includes a plurality of support members supporting the cover; as well as The second part extends from the proximal end of the first part.

48. The implant of claim 47, wherein the second portion has no supporting member.

49. The implant of claim 47, wherein the second portion is formed by the cover.

50. The implant of claim 49, wherein the cover is fabric.

51. The implant of claim 49, wherein the second portion is a cylindrical cuff.

52. The implant of claim 49, wherein the second portion comprises rolled-up fabric.

53. The implant of claim 47, wherein the second portion is coupled to the first portion along the distal edge of the second portion.

54. The implant of claim 47, wherein the second portion is coupled to the first portion along the width of the second portion.

55. The implant of claim 47, wherein the second portion is curved.

56. The implant of claim 47, wherein the ratio of the length of the attachment portion to the length of the engagement portion is between about 1:1 and about 1.5:

1.

57. An implant for reducing valvular regurgitation, said implant comprising: The attachment portion includes at least a first portion of the first arm and the second arm. The first arm and the second arm are configured to connect the implant to the first native leaflet; as well as The joining portion is configured to provide a contact surface for the second primary leaflet. The ratio of the length of the first native leaflet to the length of the implant is between approximately 1:1 and approximately 2:

1.

58. A method for reducing valvular regurgitation, the method comprising: An implant in a delivery configuration is advanced to a heart valve via a delivery device. The implant includes a first arm, a second arm, and a plurality of support members, each support member extending from the first arm to a corresponding free end. Separate the first arm and the second arm; The first arm is positioned on a first side of the heart valve and the second arm is positioned on a second opposite side of the heart valve; as well as Release at least one of the first arm and the second arm to attach the implant to one or more of the native leaflets or chordae tendineae of the heart valve.

59. The method of claim 58, the method further comprising determining a first location of the implant via a radiopaque marker coupled to the first arm or the second arm.

60. The method of claim 58, wherein the first planar portion of the first arm and the second planar portion of the second arm are coplanar in the delivery configuration.

61. The method of claim 58, wherein the plurality of support members are elongated in the delivery configuration.

62. The method of claim 58, wherein separating the first arm and the second arm comprises pulling a suture through at least one of a plurality of suture holes in the first arm or the second arm.

63. The method of claim 62, wherein releasing the first arm and the second arm comprises reducing the tension of the suture applied to at least one of the plurality of suture holes passing through the first arm or the second arm.

64. The method according to claim 58, wherein, When connected to the heart valve, the plurality of friction elements of the first arm and the plurality of friction elements of the second arm each engage the heart valve.

65. The method of claim 64, wherein the first arm and the second arm are separated by applying a separating force of about 150 mN to about 600 mN to the first arm and the second arm.

66. The method of claim 58, the method further comprising removing the implant from the heart valve.

67. The method of claim 58, further comprising: After the first and second arms are released to attach the implant to the heart valve, the implant is repositioned relative to the heart valve.

68. The method of claim 67, wherein repositioning the implant includes a second separation of the first arm and the second arm, moving the implant relative to the heart valve, and a second release of the first arm and the second arm to reattach the implant to the heart valve.

69. The implant of claim 58, further comprising selecting an implant from a plurality of implants.

70. The implant according to claim 58, wherein the heart valve is selected from the group consisting of the mitral valve, tricuspid valve, aortic valve and pulmonary valve.

71. The implant of claim 58, wherein the implant is configured to be non-destructively attached to the heart valve.

72. An implant for reducing valvular regurgitation, said implant comprising: A central component, the central component having a first end and a second end; The first segment extends from the first end of the central member and includes a planar portion and a curved portion; The second segment extends from the second end of the central member; as well as Multiple support members, each extending from the first segment to a corresponding free end.

73. A method of implanting an implant into a native heart valve leaflet of a patient's heart to reduce valvular regurgitation, said implant comprising (1) a pair of arms movable between a resting closed position and a biased open position, said pair of arms in the biased open position defining a space therebetween sufficient to capture the free end of the native valve leaflet between said pair of arms, and (2) a leaflet enhancer, said method comprising: A steerable guiding catheter is inserted through the patient's vascular system. The steerable guiding catheter has an implantable catheter that is slidably and rotatably disposed therein, such that the distal end of the guiding catheter is positioned in the atrium of the heart. During the insertion, the implant is in its closed position and is detachably coupled to the distal portion of the implantable catheter. With the guiding catheter positioned within the atrium, the implant catheter is advanced relative to the guiding catheter to expose the implant within the atrium; The implant is moved from its closed position to the bias-open position; Align the implant to position the free end of the native leaflet within the space; as well as With the free end of the native leaflet positioned within the space, the implant is moved from the biased open position to its closed position to clamp the free end of the native leaflet between the pair of arms.

74. The method according to claim 73, further comprising: With the guiding catheter positioned within the atrium and the implant catheter advanced to expose the implant from the guiding catheter, the implant catheter is rotated relative to the guiding catheter to align the implant with the native leaflet.

75. The method of claim 73, wherein the pair of arms comprises a first arm and a second arm, and changing the implant from the closed position to the bias-open position comprises: Tension is applied to the first tether that is detachably attached to the first arm; as well as After applying tension to the first tether, tension is applied to the second tether, which is detachably connected to the second arm.

76. The method of claim 75, wherein changing the implant from the bias-open position to the closed position comprises: Release the tension applied to at least one of the first or second tether.

77. The method of claim 76, further comprising: After releasing the tension and with the first tether detachably connected to the first arm and the second tether detachably connected to the second arm, the implant catheter is partially withdrawn from the implant and the native leaflet to visualize the effect of the implant on the native heart valve engagement.

78. The method of claim 77, further comprising: Separate the first tether and the second tether from the first arm and the second arm of the implant; Withdraw the implant catheter and the guide catheter, wherein the implant is clamped to the free end of the native leaflet.

79. The method of claim 77, wherein a first portion of the free end of the original leaflet is clamped between the first arm and the second arm, the method further comprising: The implant catheter is advanced toward and into contact with the implant, and tension is applied to at least one of the first tether or the second tether to cause the implant to shift away from the closed position to release the native leaflet between the pair of arms; The implant is redeployed to a second portion of the original leaflet, different from the first portion. Withdraw the implant catheter and the guide catheter, wherein the implant is clamped to the second portion of the original leaflet.

80. The method of claim 73, wherein the pair of arms includes a first arm and a second arm, the implant catheter defines a single lumen and houses four elongated members within the single lumen, each elongated member defining a lumen therethrough, and changing the implant from its closed position to the biased open position comprises: Tension is applied to the first tether, which is detachably connected to the first arm, and the second tether, which is detachably connected to the second arm. The first tether extends through the first and second elongated members of the four elongated members, such that the tension applied to the two free ends of the first tether applies tension to the first arm. The second tether extends through the third and fourth elongated members of the four elongated members, such that the tension applied to the two free ends of the second tether applies tension to the second arm.

81. A system for delivering an implant to a native heart valve leaflet of a patient's heart to reduce valvular regurgitation, the implant comprising (1) an atrial arm and a ventricular arm, the atrial arm and the ventricular arm being movable together between a resting closed position and a biased open position, the biased open position defining space sufficient to capture the free end of the native leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer, the system comprising: An implant catheter having a distal portion configured to retain the implant. The distal portion defines a first atrial passage and a second atrial passage, both configured to slidably receive an atrial arm tether. The ventricular portion defines a first ventricular passage and a second ventricular passage, both configured to slidably receive a ventricular arm tether. The first ventricular passage terminates at a first ventricular opening in the distal portion, and the second ventricular passage terminates at a second ventricular opening in the distal portion, allowing the ventricular arm tether to extend therefrom and be slidably and detachably attached to the ventricular arm of the implant. The atrial passage terminates at a first atrial opening in the distal portion, and the second atrial passage terminates at a second atrial opening in the distal portion, to allow the atrial arm tether to extend therefrom and be slidably and detachably attached to the atrial arm of the implant. The implant catheter has a proximal portion defining a single lumen extending from the distal portion, and accommodates four elongated members, each elongated member defining a lumen therethrough. The first and second elongated members of the four elongated members are configured to slidably accommodate the atrial arm tether, and the third and fourth elongated members of the four elongated members are configured to slidably accommodate the ventricular arm tether.

82. The system of claim 81, wherein the distal portion defines a cavity configured to receive a first portion of the implant, the distal portion further including an engagement surface proximal to the cavity, and the second portion of the implant being configured to adjoin the engagement surface.

83. The system of claim 81, wherein tension applied to the proximal portion of the atrial tether causes the second portion of the implant to abut the engagement surface.

84. The system of claim 81, wherein the distal portion includes a curved distal end.

85. The system of claim 83, wherein tension applied to the proximal portion of the ventricular tether causes the ventricular arm of the implant to move away from the atrial arm of the implant, thereby changing the implant from the closed configuration to the open configuration, the ventricular arm and the atrial arm defining a space therebetween, the space being configured to accommodate a portion of the native heart valve leaflet when the implant is in the open configuration.

86. The system of claim 84, wherein when the native heart valve leaflet is disposed in the space and tension is released from the proximal portion of the ventricular tether, the ventricular arm moves toward the atrial arm to clamp the portion of the native heart valve leaflet therebetween.

87. The system of claim 86, wherein tension is released from the proximal ends of the atrial tether and the ventricular tether such that the implant catheter can be withdrawn proximally from the implant.

88. The system of claim 81, wherein the atrial passage is positioned and aligned with a positioning opening defined by the atrial arm of the implant, wherein the ventricular passage is positioned and aligned with a positioning opening defined by the ventricular arm of the implant.

89. The system of claim 81, further comprising: An atrial tether actuator, wherein at least one free end of the free ends of the atrial arm tether is connected to the atrial tether actuator; A ventricular tether actuator, wherein at least one free end of the free end of the ventricular tether is connected to the ventricular tether actuator. The atrial tether actuator and the ventricular tether actuator are configured to apply tension to the atrial tether and release tension to the ventricular tether, respectively.

90. The system of claim 89, wherein the atrial tether actuator includes a first linear slider, the proximal movement of which applies tension to the atrial tether, and the ventricular tether actuator includes a second linear slider, the proximal movement of which applies tension to the ventricular tether.

91. The system of claim 89, wherein the atrial tether actuator includes a first rack and a pinion, the ventricular tether actuator includes a second rack and a pinion, the rotation of the first rack and pinion in a first direction applies tension to the atrial tether, and the rotation of the second rack and pinion in the first direction applies tension to the ventricular tether.

92. An implant for reducing valvular regurgitation, said implant comprising: A central component, the central component having a first end and a second end; A first arm extends from the first end of the central member; The second arm extends from the second end of the central member; Multiple support members, each extending from the first arm to a corresponding free end. The first arm and a first portion of the second arm are configured to clamp around a portion of the native leaflet, the first portion of the second arm has a first width, and the second arm includes a second portion having a second width greater than the first width.

93. The implant of claim 92, wherein the first width gradually increases to the second width.

94. The implant of claim 92, wherein the central member is curved.

95. The implant of claim 92, wherein the free end of each of the plurality of support members is coplanar with the proximal surface of the central member.

96. The implant of claim 92, wherein the radius of curvature of the central member is smaller than the radius of curvature of each of the plurality of support members.

97. The implant of claim 92, wherein the central member forms at least a portion of the engagement portion.

98. The implant of claim 92, wherein the central member is configured to bias the first arm toward the second arm.

99. The implant of claim 92, further comprising: A cover, the cover being configured to surround the central member, at least a portion of the second arm, and the plurality of support members.

100. The implant of claim 92, wherein the implant further comprises: Multiple positioning openings are configured to connect the implant to an implant delivery system.

101. The implant of claim 92, wherein the plurality of positioning openings comprises a first set of positioning openings defined by the first arm and a second set of positioning openings defined by the second arm.

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