Heart valve repair device with annuloplasty features and related systems and methods

Abstract

Disclosed herein are heart valve repair devices with annuloplasty features and related systems and methods. A heart valve repair device configured in accordance with embodiments of the present technology may include, for example, an atrial fixation member configured to engage tissue within the left atrium near a native mitral valve and a spring mechanism coupled to a lower edge portion of the atrial fixation member. The spring mechanism has an extended state having a first length corresponding to the size of the atrial fixation member in an expanded state and a relaxed state having a shorter length corresponding to a desired size of the native annulus. When implanted, the spring mechanism contracts the atrial fixation member such that the cross-sectional size of the native mitral annulus anchored to the atrial fixation member is reduced.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 817,443, filed on March 12, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology relates to heart valve repair devices, and more particularly to heart valve repair devices with annuloplasty features and related systems and methods. Background Art

[0004] Conditions that affect the normal function of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is a heart disease in which the leaflets of the mitral valve fail to coapt to apposition during peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle to the left atrium. Several structural factors may affect the normal closure of the mitral valve leaflets. For example, the mitral valve annulus of many patients with heart disease is enlarged due to myocardial dilation. The enlargement of the mitral valve annulus makes it difficult for the leaflets to coapt during systole. Stretching or tearing of the chordae tendineae (the tendons connecting the papillary muscles to the underside of the mitral valve leaflets) may also affect the normal closure of the mitral valve annulus. For example, due to insufficient tension on the leaflets, rupture of the chordae tendineae may cause the valve leaflets to prolapse into the left atrium. Abnormal regurgitation may also occur when the function of the papillary muscles is impaired, for example due to ischemia. Because the left ventricle contracts during systole, the affected papillary muscles cannot contract sufficiently to achieve normal closure.

[0005] Mitral valve prolapse, or when the mitral valve leaflets abnormally bulge into the left atrium, causes abnormal behavior of the mitral valve and may also lead to mitral regurgitation. The proper function of the mitral valve may also be affected by mitral stenosis, or narrowing of the mitral valve orifice, which results in resistance to diastolic left ventricular filling.

[0006] Mitral regurgitation is typically treated with diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other treatments, such as surgery (open and endovascular), have also been used to repair or replace the valve. For example, repair procedures involve removing a portion of the dilated annulus and sewing or clipping the valve leaflets into partial apposition.

[0007] In some patients, the native mitral valve leaflets are still intact and healthy, but the dilation of the annulus prevents the leaflets from coapting during systole, leading to regurgitation. These patients may benefit from annuloplasty devices and methods, which involve implanting annular or peri-annular rings that are fixed to the annulus or surrounding tissue and constrict the annulus. This annuloplasty effectively reduces the size of the native mitral valve annulus, thereby bringing the native leaflets closer together and allowing the native leaflets (or a portion thereof) to coapt during systole.

[0008] For some patients whose mitral regurgitation is caused by factors other than annular dilation, procedures are available to address a significant portion of the mitral regurgitation. For example, placement of a clip (e.g., the Mitra-clip manufactured by Abbott Laboratories) may address flail leaflets caused by chordae tendineae rupture. Additionally, more invasive procedures involve replacement of the entire valve itself, where a mechanical valve or biological tissue is implanted in the heart to replace the mitral valve. These invasive procedures are typically done through large open-chest surgery and are therefore very painful, have a high morbidity rate, and require a long recovery period. Even with these procedures, an uncorrected dilated native annulus may result in an incomplete valve repair that does not eliminate mitral regurgitation. In these cases, devices and methods accompanying annuloplasty hold promise for enhancing mitral valve repair.

[0009] In many of these mitral valve repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can present additional problems for the patient. Furthermore, many repair procedures are highly dependent on the skill of the cardiac surgeon, where improper or inaccurate suture placement can impact the success of the procedure.

[0010] Further complicating the mitral valve repair and replacement procedure is that the mitral valve annulus has limited radial support from surrounding tissue compared to other heart valves (e.g., the aortic valve), and the mitral valve has an irregular, unpredictable shape. For example, the inner wall of the mitral valve is limited only by the thin vessel wall that separates the mitral valve annulus from the lower portion of the aortic outflow tract. Therefore, significant radial forces on the mitral valve annulus can cause collapse of the lower portion of the aortic tract, with potentially fatal consequences. The chordae tendineae of the left ventricle are often an obstacle to deploying mitral valve repair devices. The chordae maze in the left ventricle makes navigation and positioning of the deployment catheter more difficult in mitral valve repair. In view of the difficulties associated with existing procedures, there remains a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves.

[0011] BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Many aspects of the present technology may be better understood with reference to the following figures. The components in the figures are not necessarily drawn to scale, with emphasis placed on clearly illustrating the principles of the present technology. For ease of reference, the same reference numerals and / or letters are used throughout the present technology to designate similar or analogous components or features, but the use of the same reference numerals does not imply that such components should be construed as being identical. In fact, in many of the examples described herein, components with the same number refer to different embodiments that differ in structure and / or function. The headings provided herein are for convenience only.

[0013] Figure 1A and 1B is an isometric view of a mitral valve repair device configured in accordance with an embodiment of the present technology.

[0014] Figure 1C is an enlarged view of a tissue anchoring element of a mitral valve repair device configured in accordance with an embodiment of the present technology.

[0015] Figure 2A is in an initial, expanded state according to an embodiment of the present technology Figure 1A Side view of the mitral valve repair device.

[0016] Figure 2B is in a contracted, relaxed state according to an embodiment of the present technology Figure 1A Side view of the mitral valve repair device.

[0017] Figure 3 is an enlarged view of the lower edge portion of a mitral valve repair device configured according to an embodiment of the present technology.

[0018] Figure 4 is an isometric view of a mitral valve repair device configured in accordance with an embodiment of the present technology.

[0019] Figure 5A and 5B are enlarged views of tissue anchoring elements of a mitral valve repair device configured in accordance with an embodiment of the present technology in a delivery state and a deployed state, respectively.

[0020] Figure 6A Mitral valve repair devices configured in accordance with additional embodiments of the present technology are shown.

[0021] Figure 6B Mitral valve repair devices configured in accordance with additional embodiments of the present technology are shown.

[0022] Figure 7 is a side view of a heart valve repair device configured in accordance with some embodiments of the present technology. Detailed Description of the Invention

[0024] Disclosed herein are heart valve repair devices with annuloplasty features and related systems and methods. In some embodiments, for example, a heart valve repair device (also referred to as an "annuloplasty device," "mitral valve repair device," or "coaptation assist device") includes a securing member anchored to cardiac tissue of the left atrium surrounding the mitral valve annulus and a spring feature that pulls the native annulus inward to cause the valve leaflets (or portions thereof) to re-coapt during systole. Figure 1A-7 Specific details of several embodiments of the present technology are described. Although many embodiments are described below with respect to implantable devices, systems, and methods for repairing a native mitral valve, other applications and other embodiments besides those described herein are within the scope of the present technology. For example, the present technology may be used at other target sites, such as the tricuspid valve, the pulmonary valve, and / or the aortic valve. Additionally, several other embodiments of the present technology may have different configurations, components, or processes than those described herein, and features of the illustrated embodiments may be combined with each other. Therefore, one of ordinary skill in the art will accordingly understand that the present technology may have other embodiments with additional elements, or the present technology may have other embodiments without the features described below. Figure 1A-7 Other embodiments of several of the features shown and described.

[0025] With respect to the terms "distal" and "proximal" in this specification, unless otherwise indicated, the terms may provide relative positions of portions of a valve repair device and / or an associated delivery device with reference to an operator and / or a position in the vasculature or heart. For example, in reference to a delivery catheter suitable for delivering and positioning the various valve repair devices described herein, "proximal" may refer to a position closer to the operator of the device or an incision into the vasculature, while "distal" may refer to a position farther from the operator of the device or farther from the incision along the vasculature (e.g., the end of the catheter). With respect to a heart valve repair device, the terms "proximal" and "distal" may refer to portions of the device relative to the native annulus. For example, "proximal" may refer to an upstream portion of the device spaced apart from the native annulus, while "distal" may refer to a downstream position at or near the native annulus.

[0026] Overview

[0027] The present technology includes minimally invasive devices and methods for reducing the annular circumference of the atrioventricular valve. Embodiments of mitral valve repair devices with annuloplasty features disclosed herein include an anchoring member (also known as a "fixation member" or "brim") that is placed in the atrium of the heart against the atrial wall just above the atrioventricular valve. The size and shape of the anchoring member can be designed to conform to the left atrial wall just above the mitral valve annulus. In various embodiments, the anchoring member has a wedge or other friction element to maintain it in place against the atrial wall. Over a period of time after implantation (e.g., 3 days, 2 weeks, 1 month, 2 months, 3 months), the anchoring member or a portion thereof is covered by a layer of tissue, and this tissue grows inward to permanently adhere it to the atrial wall. During this recovery period, the anchoring member heals to the atrial wall (e.g., 4 to 12 weeks), at which point the circumference of the anchoring member itself begins to contract, thereby reducing the circumference of the valve annulus. The annuloplasty device can be designed to be placed in the mitral and / or tricuspid valves and can be delivered to the left atrium via a transseptal (transvenous) approach. In some embodiments, annuloplasty devices may be configured for placement at the site of other native valves, such as the aortic valve.

[0028] In some embodiments, the device is designed to differentially contract certain areas of the annulus. For example, the device can be configured to more aggressively contract the lateral and medial portions of the mitral annulus near the commissures and the P1 and P3 segments of the posterior leaflet (i.e., the medial and lateral portions of the posterior leaflet), pulling the posterior leaflet closer to the anterior leaflet. In the tricuspid valve, the device can be configured to more aggressively contract the free wall in the anterior and posterior leaflet regions.

[0029] The device can be designed to reduce the annular circumference to a very specific smaller dimension. In other embodiments, the device can be configured to apply an elastic reducing force to the annulus over a range of diameters, thereby reducing the maximum force applied to the annulus at any specific point in time.

[0030] In some embodiments, the device includes an anchoring member and one or more fixation members (e.g., screws) that secure the device to native tissue at or near the annulus to provide traditional annuloplasty tightening. In these embodiments, the anchoring member and / or features coupled thereto may also address other issues with the valve leaflets that may cause regurgitation. The anchoring member can be similar to the atrial fixation member (also known as a "rim") disclosed in International Patent Application No. PCT / US2018 / 043566, filed on July 24, 2018, which is incorporated herein by reference in its entirety. In various embodiments, the anchoring member is omitted such that the device includes one or more fixation members to provide a pure annuloplasty device.

[0031] The device can have a variety of different cross-sectional shapes. In some embodiments, for example, the device is symmetrical and / or has a consistent cross-sectional shape such that the device does not need to be oriented relative to the anterior and posterior leaflets. In other embodiments, the device has a specific asymmetrical or non-conforming shape to align with one or more anatomical landmarks, such as the posterior leaflet and / or portions thereof. For example, the asymmetrical device can have an overall shape that aligns with the generally "D-shape" of the mitral annulus and / or the fixation member can have a saddle-like shape similar to the native mitral annulus to enhance the coaptation geometry of the native leaflets. In certain embodiments, the shape of the fixation member can be similar to a surgical saddle-shaped ring, such as the Contour 3D Annuloplasty System manufactured by Medtronic.

[0032] In some embodiments, the device can be configured so that the fixation member lies flat or substantially flat against the atrial wall, which typically has different slopes relative to the valve axis at different locations around the valve. In various embodiments, for example, the fixation member can have a specific shape that is at least generally aligned with the native atrial wall structure surrounding the mitral valve. In various embodiments, the fixation member can be sufficiently flexible to conform to variations in the native anatomy of the atrial wall. In various embodiments, the anchoring member can include a portion that presses against and anchors to the inferior annular tissue.

[0033] In some embodiments, the device can be shaped to accommodate additional or other anatomical features of the atria and / or other surrounding anatomical structures. For example, when configured for annuloplasty of the mitral valve, the device can be shaped to avoid the pulmonary veins and / or the left atrial appendage. When the device is configured for implantation in the right portion of the heart, the device can be sized and shaped to avoid the coronary sinus and / or the inferior vena cava ("IVC"). In some embodiments, the device can be sized and shaped to partially or completely block the left atrial appendage to reduce or minimize the risk of thromboembolic stroke in patients with atrial fibrillation.

[0034] In some embodiments, the mitral valve repair device may further include a coupling structure (also referred to as a "spacer") extending from the anchoring member through the annulus so that the position of the coupling structure is set above a portion of the native valve leaflet. The coupling structure fills at least a portion of the space occupied by the closed native leaflet and extends beyond the space to re-establish engagement with the surrounding leaflets. For example, the coupling structure may extend in front of the central portion of the posterior leaflet (i.e., P2 of the posterior leaflet), pushing the posterior leaflet back to the ventricular wall so that the position of the coupling structure is set to engage with the anterior leaflet during systole. In some embodiments, the device further includes one or more clips extending from the anchoring member and / or coupling structure to a position behind each mitral valve leaflet to the lower annular space to further stabilize the implant. For example, the device may include a clip that reaches below P2 or other portion of the posterior leaflet to the lower annular space and further stabilizes the implant. Further description of implant devices with engagement assist devices is also described in International Patent Application No. PCT / US2018 / 043566, filed on July 24, 2018, and International Patent Application No. PCT / US2018 / 061126, filed on November 14, 2018, each of which is incorporated by reference in its entirety.

[0035] Selected embodiments of mitral valve repair devices with annuloplasty features

[0036] Figure 1A and 1B is an isometric view of a heart valve repair device 100 (also referred to as "device 100") configured in accordance with an embodiment of the present technology, Figure 1C is an enlarged view of a tissue anchor portion of a device 100 configured in accordance with an embodiment of the present technology. The device 100 includes an atrial fixation member 102 (also referred to as the "anchoring member 102" or "fixation member 102") shaped to fit and heal to the atrial wall just above a patient's atrioventricular valve (e.g., the mitral valve MV or the tricuspid valve), and one or more stretchable spring mechanisms 120 (also referred to as "spring elements") acting thereon to contract the size of the fixation member 102. The fixation member 102 may be a self-expanding frame structure that naturally expands to a size slightly larger than the existing atrial size. The fixation member 102 has an upper edge portion 104a (also referred to as the "proximal edge portion 104a" and the "first edge portion 104a") configured to be positioned in an atrial region of the heart spaced apart from the native annulus, and a lower edge portion 104b (also referred to as the "distal edge portion 104b" and the "second edge portion 104b") configured to be positioned at or adjacent to the native annulus. The spring mechanism 120 may be provided at the lower edge portion 104b. Figure 1AIn the illustrated embodiment, for example, the spring mechanism 120 surrounds the peripheral edge or perimeter of the lower portion 104b of the fixation member 102. The spring mechanism 120 may also or alternatively be positioned differently along the lower edge portion 104b, and / or the device 100 may include one or more spring mechanisms 120 along additional portions of the fixation member 102. For example, the spring mechanism 120 may include one or more spring assemblies along the wall of the fixation member 102 between the upper and lower edge portions 104a-b. Following device implantation, the spring mechanism 120 is configured to contract, drawing in adjacent portions of the fixation member 102 and the annular tissue attached thereto, thereby reducing the size of the annulus. This spring contraction may occur immediately after the fixation member is implanted and / or may begin at a delayed point in time after the fixation member 102 has healed or adhered to the adjacent heart wall.

[0037] The fixation member 102 may include an expandable mesh frame 106 (e.g., a stent) having an oval, circular, or D-shaped cross-sectional shape in the expanded state and defining an open central lumen 108 (also referred to as "opening 108") that allows blood to pass therethrough. The mesh frame 106 may be a stent made of nitinol or other suitable stent material (e.g., cut from a tube or flat sheet and formed into one or more of the above shapes). The shape of the fixation member 102 may be designed to conform to the left atrial wall just above the mitral annulus to secure the device 100 to the supraannular tissue. After implantation (e.g., 3 days, 2 weeks, 1 month, 2 months), the fixation member 102 or a portion thereof is covered by a layer of tissue, and the tissue grows inward to permanently adhere the device 100 to the atrial wall. In some embodiments, the fixation member 102 includes a covering 110 made of fabric or tissue that extends over at least a portion of the mesh frame 106 to enhance in-growth and long-term bonding to the atrial wall. In this and other embodiments, the mesh frame 106 of the fixation member 102 can be coated with or otherwise include a nitride-based nanomatrix (surface nitridation) to promote tissue ingrowth. In some embodiments, the fixation member 102 has a semicircular or other shape that does not completely extend around the circumference of the native valve. In some embodiments, the fixation member 102 can also or alternatively include one or more portions that press against the inferior annular tissue to provide inferior annular device fixation.

[0038] like Figure 1AAs shown, the device 100 can also include a plurality of barbs or wedges 112 disposed on the fixation member 102 to enhance immediate fixation, mid-term ingrowth, and long-term engagement with the atrial wall tissue to facilitate tissue fixation, thereby allowing for effective application of force and reduction of annular dimensions. These wedges 112 can be angled in one or more directions. For example, the wedges 112 can project outwardly in a distal direction toward the native annulus such that tension applied by the fixation member 102 to contract the native annulus tends to push these wedges deeper into the tissue rather than pull it out. In some embodiments, the wedges 112 can extend in a proximal direction away from the native annulus, point directly radially outward from their points of attachment on the fixation member 102, curve inwardly toward the central longitudinal axis of the device 100, and / or otherwise extend from the fixation member 102 to engage the native tissue and facilitate tissue fixation.

[0039] like Figure 1A As further shown, the fixation member 102 can include a delivery attachment feature 116 positioned along the upper edge portion 104a to facilitate connection to a delivery device (not shown). In this and other embodiments, the device 100 can include attachment features 116 along the lower edge portion 104b and / or along other portions of the fixation member 102. The attachment features 116 can include T-bars, eyelets, hooks, and / or other structures that can be secured to notches, protrusions, gripping mechanisms, sutures, and / or other corresponding parts of a delivery system.

[0040] In some embodiments, the device 100 may include one or more sewing rings 115 (also referred to as tensioning rings) extending around the circumference of the fixation member 102. The sewing rings 115 can be tensioned via a delivery system (not shown). For example, the sewing rings 115 may include or be coupled to sutures or other elongated members that extend through a delivery catheter to an exit port outside the body, where they can be pulled to tighten the sewing rings 115. Tensioning the sewing rings 115 in this manner can position the fixation member 102 in a partially constrained state, wherein the fixation member 102 has a reduced diameter compared to its fully expanded, free state. This constrained state can facilitate repositioning or retrieval of the device 100 during the delivery process. In some embodiments, the sewing rings 115 can be tensioned after the delivery process. For example, an elongated member coupled to the sewing rings 115 can be extended through an entry port (e.g., near the patient's jugular or femoral vein) to make the elongated member accessible after the delivery process. At some point after the delivery procedure, such as after tissue ingrowth has enhanced the fixation of fixation member 102 to the tissue surrounding the native annulus (e.g., approximately 3 months after the procedure), the elongation member can be pulled to tighten sewing ring 115 around fixation member 102 and reduce the overall cross-sectional area of ​​device 100. Because fixation member 102 is attached to the tissue at the annulus, tensioning of sewing ring 115 can also pull the native annulus inward to reduce the overall size of the native annulus.

[0041] In some embodiments, the fixation member 102 can have different stent shapes, sizes, and / or thicknesses in specific regions of the fixation member 102. For example, the fixation member 102 can include additional wedges, barbs, or stent structures in regions of the fixation member 102 configured to be positioned near the trigone. These additional structures can enhance the ability of the device 100 to apply force to the annulus to reduce the anterior-posterior dimension.

[0042] like Figure 1B and Figure 1C As shown in the enlarged view of FIG, in some embodiments, the device 100 further includes one or more anchoring elements 118 that are activated after the position of the fixation member 102 has been set against the atrial wall. The anchoring elements 118 can be constrained to be located within eyelets 124 ( Figure 1C ) and / or other matching structures. The locations of these anchoring elements 118 can be set at each node of the fixed member support or at specific locations along the perimeter of the support. For example, Figure 1BIn the illustrated embodiment, the anchoring elements 118 are positioned at three locations on the fixation member 102 that are configured to align with the trigone and P2 regions (central region) of the annulus. In other embodiments, the anchoring elements 118 are positioned elsewhere along the distal edge portion 104b of the fixation member 102 and / or the device 100 may include more or fewer than three anchoring elements 118.

[0043] In the illustrated embodiment, the anchoring element 118 is a helical coil anchor 126 ( Figure 1C During device deployment, the helical coil anchor 126 is releasably coupled to the torquable rod 122, and the rod 122 is rotated to push the coil anchor 126 into the heart tissue at or near the native annulus. Figure 1C As shown, the torquable rod 122 may have a groove 128 that receives a portion of the coil anchor 126 so that the shaft 122 exerts a rotational and / or downward force on the coil anchor 126 so that it engages adjacent tissue. In these and other embodiments, the torquable rod 122 may be releasably attached to the anchor element 118 using other suitable coupling mechanisms. In these and other embodiments, the anchor element 118 may have other structures suitable for anchoring the fixation member 102 to the surrounding tissue and / or may be deployed via other mechanisms, including self-deployment. In some embodiments, the anchor element 118 may be coated with PLGA and / or other coating materials to help accelerate incorporation into the surrounding tissue.

[0044] Return Reference Figure 1A , the spring mechanism 120 may include one or more springs formed as partial or full rings attached at several points around the perimeter of the fixation member 102. When the spring mechanism 120 is attached around the distal edge portion of the fixation member 102 (e.g., Figure 1A and 1B), when the device 100 is implanted, the spring mechanism 120 extends around the native annulus. The spring mechanism 120 may include one or more coil springs, such as those used on guidewires or neurovascular embolization coils. In some embodiments, the spring mechanism 120 may be close-wound so that it can be controllably contracted to a specific size, and a predetermined force is applied to incrementally stretch the spring mechanism 120 beyond that size. In other embodiments, the spring mechanism 120 may be at least slightly open-wound so that only minimal force is generated for incremental extension of the spring. In these and other embodiments, the spring mechanism 120 may have other suitable structures that can contract or otherwise reduce in length and have sufficient strength to also contract the fixation member 102 and the native tissue attached thereto. In certain embodiments, the spring mechanism 120 has a major diameter of 0.040 inches to 0.080 inches and a wire diameter of 0.06 inches to 0.016 inches.

[0045] The spring mechanism 120 may be sized so that it has a relaxed dimension having a length that generally corresponds to the desired final ring dimension. Figure 1A As shown, the relaxed size of the spring mechanism 120 can correspond to the desired annular circumference if the spring mechanism 120 extends around the lower perimeter of the fixation member 102. The size can be selected based on the size of the healthy annulus and / or the size required to provide appropriate leaflet prolapse.

[0046] Prior to implantation, when the spring mechanism 120 is attached to or otherwise connected to the fixation member 102, the spring mechanism 120 can be maintained in a pre-stretched and extended state with a bioabsorbable material. The bioabsorbable material that maintains the spring mechanism in its pre-stretched state may include PLA, PLGA, and / or other suitable bioabsorbable materials that dissolve in the body over time. When the spring mechanism 120 is a coil spring, the bioabsorbable material can be in the form of a thick thread or suture that is introduced and extended through the central opening of the coil spring. It is expected that this coaxial suture / spring arrangement will allow a relatively small diameter suture (e.g., 0.020-0.050 inches in diameter) to maintain the spring mechanism 120 in the pre-stretched state for a desired length of time. The total length of the spring mechanism 120 in the pre-stretched state can be approximately the same as the corresponding size of the fixation member 102 in the expanded, deployed state. For example, in Figure 1A In the illustrated embodiment, the length of the spring mechanism 120 in the pre-tensioned state can correspond to the circumference of the distal portion 104b of the fixation member 102 in the expanded state.

[0047] After the device 100 has been implanted and properly anchored (e.g., via structural anchoring mechanism 118 and / or tissue ingrowth) to the native tissue surrounding the annulus, the bioabsorbable material dissolves and causes the pre-stretched spring mechanism 120 to contract to its natural, relaxed state. Because the fixation member 102 is anchored to the adjacent cardiac tissue, this contraction of the spring mechanism 120 also pulls the native annulus inward to reduce the overall size of the native annulus, thereby reestablishing proper coaptation of the valve leaflets. This change from the initial pre-stretched state of the spring mechanism 120 to the contracted, relaxed state is achieved at 30°C and 35°C, respectively. Figure 2A and 2B More specifically, Figure 2A In the illustrated embodiment, the spring element 120 has a first length L1 corresponding to an extended state and is held in place by a bioabsorbable material 130 (eg, a coating or sutures). Figure 2B As shown, as the bioabsorbable material 130 dissolves, the spring element 120 contracts to a second length L2 that is shorter than the first length L1 and corresponds to a natural, relaxed state. This contraction pulls on the annulus with which it is fixed to the fixation member 102, thereby tightening the annulus to a desired size. Thus, the device 100 can reduce the size of the dilated heart valve annulus, thereby bringing the native or artificial leaflets closer together again and causing the leaflets (or a portion thereof) to coapt during systole. In addition, in some patients, there may be reason to believe that the mitral valve annulus is highly likely to dilate in the future. For these patients, preventative annuloplasty devices (e.g., the device 100 described above) that prevent future dilation are also expected to provide clinical benefits.

[0048] It should be noted that the native mitral valve can be a very rigid fibrous structure, so changing its size dramatically requires significant forces. Therefore, during surgical annuloplasty procedures where the annulus size changes dramatically, the ring that applies the force on the annulus must be very strong, and it must be very firmly anchored to the annular tissue, typically by numerous sutures that are deeply embedded in the annular tissue. In contrast, if such annular contraction occurs over a period of months and millions of heartbeats, the force required to gradually reduce the annular size may be much lower using an elastic spring member (e.g., spring mechanism 120). The associated tissue fixation forces required can likewise be much lower. Thus, the fusion of the fixation member 102 to the tissue, along with some of the barbs 112 or anchors 118 to enhance ingrowth into the tissue, is expected to be sufficient to prevent the device 100 from detaching from the annulus.

[0049] Device 100 may also be used in conjunction with other devices, such as clips to connect portions of a leaflet together, artificial leaflet devices to provide coaptation, artificial valve devices (e.g., as a landing pad or base thereof), and / or other devices to provide suitable heart valve function.

[0050] Figure 3is an enlarged view of a lower edge portion 104b of a mitral valve repair device 300 ("device 300") configured in accordance with an embodiment of the present technology. Device 300 includes various features that are at least generally similar to the features of device 100 described above. For example, device 300 includes a fixation member 102 having at least one spring mechanism 320 configured to retract the lower edge portion 104b of fixation member 102. Figure 3 In the embodiment shown, the spring mechanism 320 has varying degrees of pre-tensioned extension along its length such that certain areas of the spring mechanism 320 are more pre-tensioned than other areas. Figure 3 As shown, the spring mechanism 320 can have a first spring portion 321a that is maintained in a first pre-tensioned state (e.g., via the biocompatible material 130) and a second spring portion 321b that is maintained in a second pre-tensioned state, and the first pre-tensioned state is such that the first spring portion 321a must undergo a greater degree of displacement (e.g., contraction) than the second spring portion 321b to return to its relaxed, normal state. The first and second spring portions 321a-b can be separate spring assemblies or a single spring assembly, and each spring portion can have the same spring constant or the spring constants of the respective portions can be different. When the spring mechanism 320 is a ring disposed circumferentially around the fixation member 102 ( Figure 1A-3 ), the spring mechanism 320 can stretch more near the commissures and the lateral and medial portions of the native mitral valve than at portions aligned with the anterior and posterior of the native mitral valve. In this configuration, the contraction of the spring mechanism 320 is concentrated at the medial and lateral portions of the device 300, thereby pulling the anterior and posterior portions of the native annulus toward each other to reduce the anterior-posterior dimension of the native annulus. In some embodiments, the spring mechanism 320 can have greater contraction in portions aligned with the anterior and posterior portions of the native mitral valve to pull the medial and lateral sides of the native valve together. In some embodiments, the spring mechanism 320 can have different degrees of contraction positioned elsewhere on the fixation member and / or have a different orientation from the native anatomy to apply a desired degree of tightening to the native annulus and / or provide a desired end shape of the native annulus. Although Figure 3 A spring mechanism 320 is shown having two spring portions 321a - b with two different spring forces, but the valve repair devices disclosed herein may have more than two spring portions and / or more than two spring forces.

[0051] Figure 4 is an isometric view of a mitral valve repair device 400 ("device 400") configured in accordance with an embodiment of the present technology. Device 400 includes a mitral valve repair device 400 substantially similar to that described above with reference to FIG. Figures 1A-2B Many features of the device 100 are described, such as the securing member 402 and at least one spring mechanism 420 coupled to the lower edge portion 104b of the securing member 402. However, Figure 4 The fixation member 402 is preferably ovalized with an anterior-posterior ("AP") axis as its major axis, which can result in the medial and lateral sides of the device 400 having little contact with the wall when implanted. In addition, the spring mechanism 420 extends across the central opening 108 of the fixation member 402, rather than around its perimeter (e.g., as in FIG. Figure 1A-3 As shown). Figure 4 As shown, the spring mechanism 420 can include a first spring component 423a laterally spaced from a second spring component 423b (collectively, "spring components 423"), with the spring components 423 attached to opposite sides of the lower edge portion 104b of the fixation member 402 such that they span the diameter or chord length of the lower edge portion 104b of the fixation member 402. In this configuration, the length of the spring components 423 in the pre-tensioned state can correspond to the diameter or corresponding chord length of the distal portion 104b of the fixation member 402 in the deployed state (i.e., when unconstrained by the delivery system), and the relaxed size of the spring mechanism 420 can correspond to a desired chord length or diameter at or near the native annulus. As the spring mechanism 420 moves from its pre-tensioned size to its relaxed size (e.g., as the bioabsorbable material dissolves), the device 400 can gradually draw the native annulus inward based on the direction and relaxed size of the spring mechanism 420. For example, when the spring assemblies 423 are positioned so that they extend between the posterior and anterior portions of the native annulus, the device 400 provides contraction of the native annulus in the AP direction to bring the anterior and posterior leaflets together while avoiding additional or excessive expansion of the atrium in the commissure-to-commissure ("CC") direction.

[0052] In some embodiments, the spring mechanism 420 can have a single spring assembly that spans the diameter or other chord length of the fixation member 402, or the device 400 can include three or more spring assemblies that extend across the opening 108 of the fixation member 402. In some embodiments, the device 400 can include one or more spring assemblies that span different portions of the fixation member 402 (e.g., across the upper portion 104a of the fixation member 402, across the inner sidewall of the fixation member 402, across the opening 108 from the upper portion 104a to the lower portion 104b), the spring assemblies can have variable spring forces in a pre-tensioned state, and / or the spring assemblies can pull into the native annulus and / or other cardiac tissue attached to the fixation member 402 in different directions (e.g., a CC direction).

[0053] Figure 5A and 5B are enlarged views of a tissue anchoring element 518 of a mitral valve repair device 500 ("device 500") configured in accordance with an embodiment of the present technology in a delivery state and a deployed state, respectively. Device 500 may include a device generally similar to that described above with respect to Figure 1A-4For example, the device 500 includes a fixation member 102 and one or more anchoring elements 518 that engage cardiac tissue near the lower edge portion 104b of the fixation member 102 to enhance device fixation. Figure 1B and 1C Unlike the helical coil anchor 126 shown in FIG, the anchoring element 518 of the device 500 is a hook anchor 532 that can be coupled to the eyelet 124 and / or other connecting structure along the fixation member 102. The hook anchor 532 can be driven into tissue using a rod 522 that acts on a portion of the hook anchor 532 (e.g., flange 536). For example, Figure 5A As shown, the rod 522 can extend through a guide 534 on the fixation member 102 that is aligned with the eyelet 124, and the rod 522 can be rotated and / or longitudinally translated within the guide 534 to move the hook anchor into the tissue. When the hook anchor 532 is driven through the eyelet 124, the pressure from the eyelet 124 can fold the barbs 538 of the hook anchor 532 inward ( Figure 5A Once passed through the eyelet, the barbs 538 can spring radially outward to engage the underlying tissue, while the flange 536 extends above the eyelet 124 to maintain engagement with the fixation member 102 ( Figure 5B In some embodiments, the hook anchor 532 can have different characteristics and / or be deployed via other mechanisms, including self-deployment.

[0054] In various embodiments, the mitral valve repair devices disclosed herein may include additional components to enhance their ability to restore native valve function. For example, Figure 6A and 6B Annuloplasty devices 600A and 600B (collectively, "devices 600") are shown, respectively, configured in accordance with additional embodiments of the present technology. Devices 600 may include at least substantially similar annuloplasty devices 600A and 600B (collectively, "devices 600"). Figures 1A-5B The various features of the features of the described devices 100, 300, 400, and 500 are described. For example, the device 600 includes a fixing member 602 and one or more spring mechanisms (not shown) configured to retract a lower edge portion 604b of the fixing member 602. Figure 6AAs shown, the annuloplasty device 600A can further include one, two, or more wires or arms (individually labeled as first through fifth arms 640a-e; collectively referred to as "arms 640") that extend across at least a portion of the opening 608 of the fixation member 602 to limit prolapse of the valve leaflets. These arms 640 can extend radially inward and / or distally (e.g., toward the left ventricle) from a distal edge portion 604b of the fixation member 602 near the annulus. The arms 640 can be independent of each other, or adjacent arms 640 can be connected to each other. In some embodiments, one or more arms 640 (e.g., fifth arm 640e) can extend completely across the central opening 608 of the device 600A (i.e., across the native annulus when implanted), or two arms 640 extending from opposite sides of the fixation member 602 can be connected to each other to extend across the opening 608. In these embodiments, the arms 640 can initially extend fairly straight across the central device opening 608, and then, as the native annulus diameter is reduced over time by contraction of the device 600, the arms 640 can bend further away from the fixation member 602 in a distal direction toward the ventricle. The connecting arms 640 extending across the opening 608 of the device 600 can also have features (e.g., scores, perforations) that form weakened areas to allow one or more of the arms 640 to break and separate as desired when a predetermined force is applied thereto (e.g., to later place a prosthetic replacement valve).

[0055] like Figure 6B As shown, in some embodiments, the proximal portion of the arm 640 can be joined together by a skirt or hem 642 of fabric (e.g., ePTFE) or tissue to encourage the base of the native leaflet to grow inward and provide an atraumatic surface for the native leaflet. The fabric hem 642 may also enhance the seal in areas where the native leaflet tissue is less (such as commissures and fissures). The distal end of the arm 640 can also be covered with fabric or tissue to provide an atraumatic surface (not shown).

[0056] In some embodiments, the devices disclosed herein may include structural features that assist in the coaptation of the native leaflets. For example, Figure 7 A heart valve repair device 700 ("device 700") configured in accordance with some embodiments of the present technology is shown. Device 700 includes at least substantially similar Figures 1A-6BVarious features of the features of the devices 100, 300, 400, 500, and 600 described herein can be combined. For example, the device 700 includes an atrial fixation member 702 having an upper edge portion 704a and a lower mesh portion 704b, and one or more spring mechanisms 720 configured to contract the lower edge portion 704b of the fixation member 702. The fixation member 702 can include a mesh frame 706 having an optional suture ring 715 extending therearound to facilitate deployment, recapture, and / or constriction of the fixation member 702 following tissue ingrowth. Figure 7 As shown, the device 700 also includes an engagement structure 744 (also referred to as a "baffle" or "engagement member") that extends in a distal direction away from the lower edge portion 704b of the fixation member 702 and extends radially inward from the fixation member 702 to the central cavity 708, such that the engagement structure 744 is configured to block a portion of the native valve orifice. The engagement structure 744 has an anterior surface 746 configured to engage with at least a portion of the first native leaflet during systole and a posterior surface 748 configured to displace at least a portion of the second native leaflet. For example, when implanted within the mitral valve, the engagement structure 744 can be positioned in front of the P2 portion of the posterior leaflet to provide an anterior engagement surface 746 for the anterior leaflet. In various embodiments, the engagement structure 744 is substantially stationary (does little to no movement, unlike the native leaflets) during the cardiac cycle. In some embodiments, the engagement structure 744 moves during the cardiac cycle, similar to the native leaflets.

[0057] Suitable baffle structures are disclosed in PCT Patent Application No. PCT / US2018 / 043566, filed on July 24, 2018, entitled "Artificial Leaflet Device." In these and other embodiments, the devices disclosed herein can incorporate one or more different space-filling elements suspended from a fixation member to block a portion of the valve orifice not blocked by the native leaflets. For example, the device can include a tongue-shaped expandable element connected to the fixation member at the commissures of the valve. In other embodiments, the device can include different types of space-filling elements extending from the fixation member to facilitate engagement.

[0058] In various embodiments, the device can serve as a ring or base for future placement of a prosthetic valve replacement within the annulus. The device will have an appropriate final size (i.e., when the spring element is in its relaxed state) and spring strength to adequately retain the prosthetic valve disposed therein. The device can also be combined with minimally invasive edge-to-edge repair to provide durable, long-term reduction in mitral regurgitation.

[0059] The annuloplasty devices disclosed herein can be delivered via a variety of catheter-based approaches from the femoral vein, femoral artery, etc. to reach the native mitral valve. The tricuspid valve version of the device can be delivered from the jugular vein. These devices can also be delivered via minimally invasive transapical or transatrial approaches, or via open surgical placement. For delivery, one or more spring elements can be folded distally of the fixation member so as not to increase the overall diameter of the device in the delivery state. The shape of one or more spring elements and / or bioresorbable materials can also be designed so that the portion between the attachment points of the fixation member naturally folds distally (away from the interior of the fixation member) when the device collapses to aid in packaging for delivery and / or retrieval.

[0060] Example

[0061] Several aspects of the present technology are illustrated in the following examples.

[0062] 1. A mitral valve repair device, comprising:

[0063] an atrial fixation member configured to engage tissue within the left atrium proximate the native mitral valve annulus, the atrial fixation member comprising-

[0064] an upper edge portion configured to be disposed within the atrium spaced from the native mitral valve annulus,

[0065] a lower edge portion configured to be disposed adjacent to a native mitral valve annulus,

[0066] wherein the atrial fixation member is configured to expand from a delivery state to a deployed state;

[0067] and

[0068] a spring mechanism coupled to the lower edge portion, wherein-

[0069] the spring mechanism having an extended state having a first length corresponding to the size of the atrial fixation member in the deployed state and a relaxed state having a second length shorter than the first length, and

[0070] When implanted, the spring mechanism is configured to contract the inferior edge portion of the atrial fixation member such that a cross-sectional size of the native mitral valve annulus anchored to the atrial fixation member is reduced.

[0071] 2. The mitral valve repair device of Example 1, wherein the spring mechanism surrounds the periphery of the lower edge portion of the fixing member.

[0072] 3. The mitral valve repair device of example 1 or 2, wherein:

[0073] The atrial fixation member defines a central lumen extending therethrough; and

[0074] The spring mechanism extends across the central lumen between opposing sides of the atrial fixation member.

[0075] 4. The mitral valve repair device of any preceding example, wherein the spring mechanism comprises:

[0076] a first spring portion maintained in a first pre-tensioned state having a first spring force; and

[0077] A second spring portion is maintained in a second pretensioned state having a second spring force different from the first spring force.

[0078] 5. The mitral valve repair device of any of the foregoing examples further comprises a biocompatible material on at least a portion of the spring mechanism, wherein the biocompatible material is configured to dissolve over time to provide delayed contraction of the spring mechanism.

[0079] 6. The mitral valve repair device of any of the preceding examples, wherein the atrial fixation member comprises a mesh frame defining a central lumen configured to allow blood to pass therethrough.

[0080] 7. The mitral valve repair device of Example 6 further includes a cover extending over at least a portion of the mesh frame.

[0081] 8. The mitral valve repair device of Example 6 further comprises a plurality of wedges protruding outward from the mesh frame, wherein the wedges are configured to enhance tissue fixation.

[0082] 9. The mitral valve repair device according to any of the aforementioned examples further includes a plurality of anchoring elements along the lower edge portion of the atrial fixation member, wherein the anchoring elements are configured to engage tissue near the native mitral valve annulus after the position of the fixation member has been set against the atrial wall.

[0083] 10. The mitral valve repair device of example 9, wherein:

[0084] said atrial anchor comprising a plurality of eyelets along said lower edge portion; and

[0085] The anchoring element is a helical coil anchor configured to extend through the eyelet.

[0086] 11. The mitral valve repair device of example 9, wherein:

[0087] said atrial anchor comprising a plurality of eyelets along said lower edge portion; and

[0088] The anchoring element is a hook-shaped anchor configured to extend through the eyelet.

[0089] 12. The mitral valve repair device of any preceding example, wherein the atrial fixation member comprises a nitride-based nanomatrix coating to facilitate tissue ingrowth.

[0090] 13. The mitral valve repair device of any of the preceding examples, wherein the atrial fixation member comprises a mesh frame having an elliptical shape, the main axis of the mesh frame being configured to be oriented between the anterior wall of the left atrium and the posterior wall of the left atrium.

[0091] 14. The mitral valve repair device of any of the preceding examples, further comprising a delivery attachment feature positioned along the upper edge portion of the atrial fixation member and configured to facilitate connection to a delivery device.

[0092] 15. The mitral valve repair device according to any one of the preceding examples, wherein:

[0093] The atrial fixation member defines a central lumen configured to allow blood to pass therethrough; and

[0094] The mitral valve repair device also includes a plurality of arms extending across at least a portion of the central lumen to limit valve leaflet prolapse.

[0095] 16. The mitral valve repair device of Example 15 further includes a skirt extending inwardly from the lower edge portion toward the central cavity and positioned between the arms, wherein the skirt is configured to promote inward growth of tissue having native leaflets.

[0096] 17. A mitral valve repair device according to Example 15, wherein at least one of the arms extends fully across the central cavity, and wherein contraction of the spring mechanism causes the arms to bend away from the atrial fixation member in a direction away from the upper edge portion.

[0097] 18. The mitral valve repair device according to any one of the preceding examples, wherein:

[0098] the atrial fixation member defining a central lumen configured to allow blood to pass therethrough;

[0099] The mitral valve repair device further includes at least one arm that fully extends across the central lumen to limit valve leaflet prolapse; and

[0100] The arm has a weakened area configured to break when a predetermined force is applied to the weakened area.

[0101] 19. The mitral valve repair device according to any of the preceding examples, further comprising a sewing ring extending around the circumference of the atrial fixation member 102 and configured to be tightened to reduce the cross-sectional area of ​​the atrial fixation member.

[0102] 20. The mitral valve repair device of any preceding example, further comprising an engagement structure extending away from the atrial fixation member and extending radially inward from the atrial fixation member, the engagement structure comprising:

[0103] an anterior surface configured to coapt with the first native leaflet during systole; and

[0104] a posterior surface configured to replace at least a portion of the second native leaflet,

[0105] wherein the engagement structure is substantially stationary during the cardiac cycle.

[0106] 21. A heart valve repair device, comprising:

[0107] A fixation member configured to engage cardiac tissue in a cardiac chamber adjacent a native annulus, the fixation member comprising-

[0108] a mesh frame defining a central lumen extending therethrough,

[0109] a proximal edge portion configured to be spaced apart from the native annulus, and

[0110] a distal edge portion configured to be positioned adjacent the native annulus; and

[0111] a spring mechanism coupled to the distal edge portion, wherein-

[0112] The spring mechanism has a pre-tensioned state having a first length and a relaxed state having a second length shorter than the first length, and

[0113] When the spring mechanism moves to the relaxed state, the spring mechanism pulls the distal edge portion inward to reduce the size of the native annulus of the atrial fixation member such that the cross-sectional size of the native mitral valve annulus anchored to the atrial fixation member is reduced.

[0114] 22. The heart valve repair device of Example 21, wherein the spring mechanism extends around the perimeter of the distal edge portion.

[0115] 23. The heart valve repair device of Examples 21 or 22, wherein the spring mechanism comprises at least one spring assembly extending across a chord length of the central lumen.

[0116] 24. The heart valve repair device of any preceding example, wherein the spring mechanism comprises:

[0117] a first spring portion having a first spring force in the pre-tensioned state; and

[0118] A second spring portion has a second spring force in the pre-tensioned state, the first spring force being different from the second spring force.

[0119] 25. The heart valve repair device of any of the preceding examples, further comprising a biocompatible material configured to maintain the spring mechanism in the pre-stretched state.

[0120] 26. The heart valve repair device according to any one of the preceding examples, further comprising:

[0121] a cover extending over at least a portion of the mesh frame; and

[0122] A plurality of wedges project outwardly from the mesh frame, wherein the wedges are configured to enhance tissue fixation.

[0123] 27. The heart valve repair device according to any of the foregoing examples further includes a plurality of anchoring elements along the lower edge portion of the atrial fixation member, wherein the anchoring elements are configured to engage tissue near the native valve annulus.

[0124] 28. The heart valve repair device of Example 27, wherein the plurality of anchoring elements comprises three anchoring elements configured to align with the trigone and P2 regions of the native valve.

[0125] 29. The heart valve repair device of any of the preceding examples, further comprising a plurality of arms extending across at least a portion of the central lumen to limit valve leaflet prolapse.

[0126] 30. A method of deploying a valve repair device in a native mitral valve, the method comprising:

[0127] positioning a fixation member of a mitral valve repair device against an atrial wall in the left atrium such that the fixation member surrounds the native mitral valve annulus and the fixation member forms a central lumen through which blood flows into the native mitral valve;

[0128] The distal edge portion of the fixation member is engaged with tissue of the native mitral valve annulus such that a spring mechanism coupled to the distal edge portion is disposed at the native mitral valve annulus in a pre-stretched state, wherein the spring mechanism is configured to move to a relaxed state, pulling the distal edge portion and the tissue engaged therewith inward to reduce the size of the native mitral valve annulus.

[0129] 31. The method of Example 30, wherein engaging the distal edge portion comprises extending an anchoring element coupled to the distal edge portion to tissue of the native mitral annulus.

[0130] 32. The method of example 31, wherein extending the anchoring element to the tissue comprises:

[0131] first and second anchoring elements engaged about the triangle; and

[0132] A third anchoring element engages near the P2 region of the native mitral valve.

[0133] in conclusion

[0134] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, as those skilled in the relevant art will recognize, various equivalent modifications may be made within the scope of the present technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0135] It will be understood from the foregoing that specific embodiments of the present technology are described herein for illustrative purposes, but to avoid unnecessarily obscuring the description of the embodiments of the present technology, well-known structures and functions are not shown or described in detail. Where the context permits, singular or plural terms may also include the plural or singular terms, respectively.

[0136] In addition, unless the word "or" is expressly limited to referring only to a single item in a list of two or more items that does not include other items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" refers throughout to including at least one or more of the described features, so that additional types of any greater number of the same features and / or other features are not excluded. It will also be understood that, for illustrative purposes, specific embodiments are described herein, but various modifications may be made without departing from the present technology. In addition, although the advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit these advantages, and not all embodiments need to exhibit these advantages to fall within the scope of the present technology. Therefore, the present disclosure and related technology may include other embodiments not explicitly shown or described herein.

Claims

1. A mitral valve repair device, comprising: An atrial fixation member configured to engage tissue within the left atrium proximate a native mitral valve annulus, the atrial fixation member comprising: an upper edge portion configured to be disposed within the atrium spaced from the native mitral valve annulus, a lower edge portion configured to be disposed adjacent to a native mitral valve annulus, wherein the atrial fixation member is configured to expand from a delivery state to a deployed state; and a spring mechanism coupled to the lower edge portion, wherein The spring mechanism has an extended state and a relaxed state, the atrial fixation member is in the deployed state, the biocompatible material on at least a portion of the spring mechanism enables the spring mechanism to be in the extended state, and the spring mechanism has a first length. When implanted, the biocompatible material dissolves over time, placing the spring mechanism in a relaxed state. The spring mechanism has a second length that is shorter than the first length. The spring mechanism contracts the lower edge portion of the atrial fixation member, reducing the cross-sectional size of the native mitral valve annulus anchored to the atrial fixation member.

2. The mitral valve repair device according to claim 1, wherein: The spring mechanism surrounds a periphery of the lower edge portion of the securing member.

3. The mitral valve repair device according to claim 1, wherein: the atrial fixation member defining a central lumen extending therethrough; and The spring mechanism extends across the central lumen between opposing sides of the atrial fixation member.

4. The mitral valve repair device according to claim 1, wherein: The spring mechanism comprises: a first spring portion which, in said extended state, is maintained in a first pre-tensioned state having a first spring force; and The second spring portion, in the extended state, is maintained in a second pre-tensioned state having a second spring force different from the first spring force.

5. The mitral valve repair device according to claim 1, wherein: The atrial fixation member includes a mesh frame defining a central lumen configured to allow blood to pass therethrough.

6. The mitral valve repair device of claim 5, further comprising a cover extending over at least a portion of the mesh frame.

7. The mitral valve repair device according to claim 5, further comprising a plurality of wedge-shaped members protruding outward from the mesh frame, wherein The wedge is configured to enhance tissue fixation.

8. The mitral valve repair device according to claim 1, further comprising a plurality of anchoring elements along the lower edge portion of the atrial fixation member, wherein The anchoring element is configured to engage tissue adjacent to the native mitral valve annulus after the fixation member has been positioned against the atrial wall.

9. The mitral valve repair device according to claim 8, wherein: said atrial fixation member comprising a plurality of eyelets along said lower edge portion; and The anchoring element is a helical coil anchor configured to extend through the eyelet.

10. The mitral valve repair device according to claim 8, wherein: said atrial fixation member comprising a plurality of eyelets along said lower edge portion; and The anchoring element is a hook-shaped anchor configured to extend through the eyelet.

11. The mitral valve repair device according to claim 1, wherein: The atrial fixation member includes a nitride-based nanomatrix coating to facilitate tissue ingrowth.

12. The mitral valve repair device according to claim 1, wherein: The atrial fixation member includes an oval mesh frame, the main axis of which is oriented between the anterior wall of the left atrium and the posterior wall of the left atrium.

13. The mitral valve repair device of claim 1, further comprising a delivery attachment feature positioned along the upper edge portion of the atrial fixation member and configured to facilitate connection to a delivery device.

14. The mitral valve repair device according to claim 1, wherein: The atrial fixation member defines a central lumen configured to allow blood to pass therethrough; and The mitral valve repair device also includes a plurality of arms extending across at least a portion of the central lumen to limit valve leaflet prolapse.

15. The mitral valve repair device of claim 14, further comprising a skirt extending from the lower edge portion inwardly toward the central cavity and positioned between the arms, wherein The skirt is configured to promote ingrowth of tissue having native leaflets.

16. The mitral valve repair device according to claim 14, wherein: At least one of the arms extends fully across the central lumen, and wherein contraction of the spring mechanism causes the arm to flex away from the atrial fixation member in a direction away from the upper edge portion.

17. The mitral valve repair device according to claim 1, wherein: the atrial fixation member defining a central lumen configured to allow blood to pass therethrough; The mitral valve repair device further includes at least one arm that fully extends across the central lumen to limit valve leaflet prolapse; and The arm has a weakened area configured to break when a predetermined force is applied to the weakened area.

18. The mitral valve repair device of claim 1, further comprising a sewing ring extending around a circumference of the atrial fixation member and configured to be tightened to reduce a cross-sectional area of ​​the atrial fixation member.

19. The mitral valve repair device of claim 1 , further comprising an engagement structure extending away from the atrial fixation member and extending radially inward from the atrial fixation member, the engagement structure comprising: an anterior surface configured to coapt with the first native leaflet during systole; and a posterior surface configured to replace at least a portion of the second native leaflet, wherein the engagement structure is substantially stationary during the cardiac cycle.

20. A heart valve repair device, comprising: A fixation member configured to engage cardiac tissue in a cardiac chamber proximal to a native annulus, the fixation member comprising: a mesh frame defining a central lumen extending therethrough, a proximal edge portion configured to be spaced apart from the native annulus, and a distal edge portion configured to be positioned adjacent the native annulus; and a spring mechanism coupled to the distal edge portion, wherein The spring mechanism has a pre-stretched state having a first length and a relaxed state having a second length shorter than the first length, and a biocompatible material on at least a portion of the spring mechanism causes the spring mechanism to be in the pre-stretched state, and the biocompatible material dissolves over time so that when the spring mechanism moves to the relaxed state, the spring mechanism pulls the distal edge portion inwardly, causing the cross-sectional size of the native valve annulus anchored to the fixation member to decrease.

21. The heart valve repair device according to claim 20, wherein: The spring mechanism extends around the perimeter of the distal edge portion.

22. The heart valve repair device according to claim 20, wherein: The spring mechanism includes at least one spring component extending across a chord length of the central cavity.

23. The heart valve repair device according to claim 20, wherein: The spring mechanism comprises: a first spring portion having a first spring force in the pre-tensioned state; and A second spring portion has a second spring force in the pre-tensioned state, the first spring force being different from the second spring force.

24. The heart valve repair device according to claim 20, further comprising: a cover extending over at least a portion of the mesh frame; and A plurality of wedges project outwardly from the mesh frame, wherein the wedges are configured to enhance tissue fixation.

25. The heart valve repair device of claim 20, further comprising a plurality of anchoring elements along the distal edge portion of the fixation member, wherein The anchoring element is configured to engage tissue adjacent the native annulus.

26. The heart valve repair device according to claim 25, wherein: The plurality of anchoring elements includes three anchoring elements configured to align with central regions of the trigone and posterior leaflets of the native valve.

27. The heart valve repair device of claim 20, further comprising a plurality of arms extending across at least a portion of the central lumen to limit valve leaflet prolapse.

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