WO2025233662A1

WO2025233662A1 - Atrioventricular valves annulus stabilizing, restraining and reshaping methods and devices

Info

Publication number: WO2025233662A1
Application number: PCT/IB2024/054532
Authority: WO
Inventors: Christoph Huber
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-05-09
Filing date: 2024-05-09
Publication date: 2025-11-13
Anticipated expiration: 2026-11-09

Abstract

The heart valve annulus stabilizing, restraining, and reshaping device introduces a novel approach to cardiovascular interventions. Unlike conventional single restraining devices, it incorporates two separate elastic elements, each with half of a D-shaped configuration, significantly enhancing stability and flexibility. The system offers minimally invasive options, featuring multiple configurations for percutaneously delivering and strategically positioning on the respective valve annulus. Central to its effectiveness is a meticulously engineered fixation mechanism, featuring anchoring portions distributed strategically for optimal stability. The incorporation of a shape memory element empowers dynamic configuration adaptation, ensuring optimal engagement with the valve annulus, this allows for precise control over its dimensions. This versatile device promises enhanced patient outcomes through targeted annular modifications, offering a new level of precision in valvular interventions.

Description

ATRIOVENTRICULAR VALVES ANNULUS STABILIZING, RESTRAINING AND RESHAPING METHODS AND DEVICES

TECHNICAL FIELD

[0001] The present disclosure generally relates to a heart valve stabilization device and, more specifically, to mitral annulus stabilization.

BACKGROUND OF THE INVENTION

[0002] Heart valves play a crucial role in maintaining proper blood circulation within the circulatory system. The circulatory system's core components consist of the heart and interconnected vessels, facilitating blood circulation throughout the body. The human heart consists of four chambers, namely the left and right atrium and the left and right ventricles, each separated by specific valves. These valves include the mitral, tricuspid, aortic, and pulmonic valves. The heart's four chambers function harmoniously with the valves to propel blood through the circulatory system.

[0003] However, these valves can become damaged or dysfunctional due to various factors, such as aging or disease, resulting in two main issues: a) Stenosis, where a valve does not open fully, causing restricted blood flow, and b) Regurgitation (or insufficiency), where blood leaks backward through a valve when it should be closed.

[0004] Mitral valve regurgitation/insufficiency, a prevalent condition, can seriously impair circulatory efficiency and is often associated with changes in the left ventricle, papillary muscles, and mitral valve annulus. These changes can result in ineffective leaflet closure during ventricular systole, causing regurgitation. Left untreated, this condition can lead to disease progression and further complications. In some cases, the correction may involve reducing the size of the mitral annulus rather than repairing the valve leaflets themselves, using various techniques.

[0005] To address severe cases of valve dysfunction, medical intervention such as valve replacement or repair becomes necessary. Traditional approaches involve open-heart surgery, which is accompanied by inherent risks, significant expenses, and extended recovery periods. Moreover, open-heart surgery involves cardiopulmonary bypass, raising the potential for complications like thrombosis, stroke, and infarction.

[0006] Current surgical procedures offer both valve replacement and repair options. Replacement can be done through open-heart surgery or percutaneously, involving the removal of the native valve and placement of a prosthetic valve. However, this may introduce complications like the risk of endocarditis, especially in mechanical valve replacements requiring anticoagulation treatment. Valve repair techniques include resection of a diseased posterior leaflet, chordae transposition, valvuloplasty, chordae reattachment or shortening, and annuloplasty, which contracts the valve annulus using a prosthetic annuloplasty ring. These methods often require cardiopulmonary bypass, although less invasive approaches are emerging.

[0007] Various heart valve repair procedures aim to address regurgitation, with success rates depending on factors like the surgeon's experience and anatomical conditions. Repair offers advantages over replacement, including better cardiac function preservation and reduced risk of complications.

[0008] In recent years, minimally invasive procedures have emerged, eliminating the need for open-heart surgery and cardiopulmonary bypass. One such approach involves implanting devices into the coronary sinus to remodel the mitral annulus, improving leaflet coaptation. However, these procedures may not be suitable for all patients due to anatomical variations or weakened coronary sinuses.

[0009] Various annuloplasty ring devices have been developed to address the needs of patients with mitral valve regurgitation. These devices aim to provide structural support and stabilization to the natural human heart valve. Some known devices, such as those disclosed in U.S. Pat. No. 6, 102,945, feature a flexible design with separable anterior and posterior sections, primarily relying on interconnectivity for size variability.

[0010] Additionally, expandable annuloplasty rings, as outlined in European Pat. No. EP099639, have been proposed. These rings possess the capability to expand either spontaneously in response to the patient's growth or through surgical intervention using balloon dilatation. This innovation is particularly suitable for pediatric patients, adapting overtime to accommodate natural growth.

[0011] Devices and methods for reshaping the mitral valve annulus have also been explored, as detailed in U.S. Pub. No. 20110015722. One such device is configured for deployment in the right atrium and exerts force along the atrial septum, inducing deformation that shifts the anterior leaflet of the mitral valve in a posterior direction, effectively reducing mitral valve regurgitation.

[0012] Furthermore, U.S. Pub. No. 20110257741 introduces the use of clips and magnetic tissue shaping devices to remodel heart tissue and enhance heart valve function. These devices utilize mutually attractive or repulsive elements to achieve their remodeling effect, and they may be activated within the patient through less invasive or non-invasive means.

[0013] Despite these innovations, there remains a need for an annuloplasty ring device that incorporates two members securely fixed to the mitral annulus, enabling controlled adjustment of a semi-annulus of the mitral valve. Unlike existing solutions, which primarily focus on smaller, independently acting tissue fasteners around the mitral annulus, the present invention aims to introduce lateral fixation elements for precise manipulation. [0014] U.S. Pat. No. 8,226,709 presents a system and method for treating mitral valve regurgitation by reshaping the mitral valve annulus through the application of one or more pleats in annular or adjacent tissue, each secured by a retainer. This system employs four distinct devices for achieving percutaneous direct plication annuloplasty.

[0015] Furthermore, U.S. Pat. No. 11,529,232 introduces an implantable annuloplasty ring device featuring numerous tissue anchors. When deployed, the unfolded annuloplasty ring is positioned within a body element's cavity to constrict a bodily opening, effectively addressing regurgitation in the area of the heart. However, the patent does not provide explicit details on the inducement of the annuloplasty ring's configuration.

[0016] Uastly, U.S. Pat. No. 11,576,782 presents a system designed to treat a patient's native valve. It includes a prosthetic valve repair device implantable in a sub annular position relative to the native valve. This device, placed under the posterior leaflet exclusively, undergoes configuration changes by filling with either liquid or gas, further demonstrating versatility in addressing valve-related issues.

[0017] Within the realm of annuloplasty rings used in valve repair, distinctions exist in terms of stiffness, completeness, and adjustability. Deciding between partial and complete rings can be influenced by surgical preference or the patient's condition, adding complexity and cost to inventory management.

[0018] In response to these challenges, an ideal annuloplasty ring would allow surgeons to anchor the posterior portion while assessing the need for a complete or partial ring. This flexibility would streamline decision-making during surgery and potentially enhance patient outcomes.

SUMMARY OF INVENTION:

[0019] The conventional approaches to annulus stabilization in cardiac interventions predominantly rely on single restraining devices characterized by circular, nearly closed designs. These devices exhibit inherent limitations, particularly in addressing lateral dilatation of the annulus, a critical concern in many cardiovascular conditions.

[0020] The present invention, however, takes a markedly innovative approach. By introducing two separate and elastic elements, each possessing half of a D-shaped configuration, the device enhances stability and flexibility. It is imperative to note that these elements are intentionally designed to remain detached, steering clear of conventional practices wherein they are interconnected. The device is delivered percutaneously, directly impacting the respective valve annulus. For example, in mitral valve interventions, it is applied on the left side, and for tricuspid valve procedures, on the right side. This strategic positioning ensures precise control over the annular dimensions. [0021] The heart valve annulus stabilizing, restraining, and reshaping device represents a revolutionary leap in cardiovascular interventions, introducing a paradigm shift in approaches to valvular modification. Its pivotal features encompass a meticulously designed body that mirrors the contours of a heart valve annulus, featuring a multitude of anchoring portions. Crucially, the incorporation of a shape memory element, extending over half the body's length, endows the device with the capacity to dynamically adapt its configuration. This innovation allows it to assume a substantially arcuate shape in its second configuration, ensuring optimal engagement with the valve annulus.

[0022] At the heart of its efficacy lies the fixation mechanism, characterized by at least one meticulously engineered fixation member. This element serves as the linchpin, facilitating robust anchoring of the implant within the valve annulus and adjacent paravalvular region, encompassing both the valve leaflets and the valve apparatus.

[0023] The device's versatility shines through in its adaptability to a range of implantation techniques, including endovascular, percutaneous, and transcatheter procedures. This flexibility renders it a versatile tool, seamlessly integrated into a diverse array of clinical scenarios.

[0024] Crucially, the anchoring configuration of the device is strategically distributed, optimizing stability and enabling precise control over the annular dimensions. The first anchoring portion, positioned at the first end, synergizes with the second anchoring portion, strategically located in the middle section, and the third anchoring portion, situated at the second end. This deliberate arrangement ensures a secure and controlled engagement with the valve annulus, further enhancing the device's effectiveness in stabilizing, restraining, and reshaping the targeted anatomical structure.

[0025] This comprehensive and innovative approach marks a significant advancement in cardiovascular interventions, promising enhanced patient outcomes through targeted annular modifications, ushering in a new era of precision-driven valvular interventions.

[0026] One embodiment, accordingly, provides an annuloplasty device which is flexible and includes two separate lateral members. A principal advantage of this embodiment is that an annuloplasty device is provided which is formed by two separate members which can be used in complete ring form or separated to be used in partial ring.

[0027] The introduction and utilization of this device ushers in a notable shift in the landscape of annuloplasty procedures. Specifically, the proportion of traditional annuloplasty devices is substantially supplanted by transcatheter devices. This paradigm shift underscores the transformative potential of this invention in redefining the approaches to valvular interventions. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1 shows a standard surgical annuloplasty ring;

[0029] FIG 2 shows a possible proportion of the annuloplasty device replaced by the transcatheter devices;

[0030] FIG. 3 shows the mechanism of restricting/reshaping of the mitral annulus as to reduce the anterior-posterior diameter and to eliminate/reduce the dilatation causing the valve regurgitation.;

[0031] FIG. 4 shows the said mechanism and some illustrative anchoring catheter;

[0032] FIG. 5 shows the different configuration of the device for transcatheter insertion;

[0033] FIG. 6 shows the asymmetrical shape of the device close to a half D-shape;

[0034] FIG. 7 shows an anchoring mechanism using a loop to be passed from a first cavity to a second cavity and recaptured by a dedicated loop/lasso to have it pulled through and out. And fixed with a compression system as to have both ends secured;

[0035] FIG. 8A & 8B show a possible aid to anchoring providing temporarily fixed elongated thin members that allow to guide anchoring catheters from outside the body;

[0036] FIG. 9 shows the various configurations of the device (extended, for transcatheter insertion, configuration 1 and configuration 2);

[0037] FIG. 10 shows a possible use in a tricuspid valve reducing the size of the septal leaflet to create a better coaptation of the anterior and posterior leaflet;

[0038] FIG. 11 shows device configuration to adapt to the saddle shaped mitral valve annulus;

[0039] FIG. 12 shows the 2-dimensional size reduction and changes in device configuration;

[0040] FIG. 13 shows the 3-dimensional size reduction and changes in device configuration;

[0041] FIGS. 14 -20 shows some 3 -dimensional shapes to accommodate to the native saddle shape of the mitral annulus;

[0042] FIG. 21 shows left part of the heart including Atrium, ventricle and mitral valve. A stabilizing arch is added to the member/device for additional strength and flexibility to follow the expansion movement;

[0043] FIG. 22 shows a mitral clip fixed at the center of the mitral valve and the member of the present invention is implanted laterally on the either side of the mitral valve; and [0044] FIG. 23 shows mitral valve in open and closed position after being repaired. DETAILED DESCRIPTION

[0045] The foregoing disclosure provides illustration and description but is not intended to be exhaustive or to limit the implementations to the precise form disclosed. Modifications may be made in light of the above disclosure or may be acquired from practice of the implementations. As used herein, the term “component” is intended to be broadly construed as hardware, firmware, or a combination of hardware and software . It will be apparent that systems and/or methods de scribed herein may be implemented in different forms of hardware, firmware, and/or a combination of hardware and software. The actual specialized control hardware or software code used to implement these systems and/or methods is not limiting of the implementations. Thus, the operation and behavior of the systems and/or methods are described herein without reference to specific software code - it being understood that software and hardware can be used to implement the systems and/or methods based on the description herein. As used herein, satisfying a threshold may, depending on the context, refer to a value being greater than the threshold, greater than or equal to the threshold, less than the threshold, less than or equal to the threshold, equal to the threshold, and/or the like, depending on the context. Although particular combinations of features are recited in the claims and/or disclosed in the specification, these combinations are not intended to limit the disclosure of various implementations. In fact, many of these features may be combined in ways not specifically recited in the claims and/or disclosed in the specification.

[0046] Although each dependent claim listed below may directly depend on only one claim, the disclosure of various implementations includes each dependent claim in combination with every other claim in the claim set. No element, act, or instruction used herein should be construed as critical or essential unless explicitly described as such. Also, as used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more.” Further, as used herein, the article “the” is intended to include one or more items referenced in connection with the article “the” and may be used interchangeably with “the one or more.” Furthermore, as used herein, the term “set” is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, and/or the like), and may be used interchangeably with “one or more.” Where only one item is intended, the phrase “only one” or similar language is used. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise. Also, as used herein, the term “or” is intended to be inclusive when used in a series and may be used interchangeably with “and/or,” unless explicitly stated otherwise (e.g., if used in combination with “either” or “only one of’).

[0047] The heart valve annulus stabilizing, restraining, and reshaping device is meticulously engineered to address critical challenges in cardiovascular interventions. Comprising two distinct and elastic elements, each embodying half of a D-shaped configuration, the device represents a departure from conventional practices (FIG.l). Notably, these elements are intentionally designed to remain detached, foregoing the common practice of interconnection. This unique design allows for precise control over the annular dimensions without exerting force or deformity on the interatrial septum or anchoring in the caval veins.

[0048] In practical applications, the device is delivered percutaneously and positioned laterally on either side of the mitral valve 22 or tricuspid valve 38. This strategic positioning ensures that the lateral members are securely affixed to the respective valve annulus. The primary focus of the invention lies in addressing lateral dilatation, particularly on the supra-annular side. In certain cases, sub-annular reinforcement may be employed to enhance anchoring safety. An adjustment filament is incorporated to fine-tune the configuration, allowing for precise customization based on individual patient anatomy.

[0049] FIG. 2 illustrates a flexible restraining device (annuloplasty device) 200 specifically designed for addressing mitral valve regurgitation. This flexible annuloplasty device 200 is composed of two distinct members, denoted as 2 and 4. It consists of a first arcuate shape member 2 and a second arcuate shape member 4. Notably, these two members remain unconnected and are positioned in opposition to each other, being laterally affixed to the mitral annulus. They serve to alter one semi-annulus dimension of the mitral valve. FIG. 3 presents these separate flexible members 2 and 4 in an arcuate configuration, representing the shape they will assume upon delivery to the supra-annular side. This configuration predominantly targets the supra-valvular position of the mitral valve.

[0050] The Flexible members 2, 4 are made of a flexible, biocompatible material that has “shape memory alloy” 10 so that flexible member 2, 4 can be extended into an elongated configuration 30 and inserted into a delivery catheter but will assume a curved shape and dimensions when supra-anular side on the mitral valve annulus. In one embodiment of the invention, flexible members 2, 4 comprise nitinol, a biocompatible material that gives flexible members 2, 4 the needed flexibility and shape memory. In one embodiment of the invention, flexible members 2, 4 comprise a flexible, nitinol wire with a cover 6. In one embodiment, cover 6 is composed of a material known in the art to have the necessary hemocompatible properties and may be used in the cardiovascular system.

[0051] The incorporation of a shape memory element, crafted from a shape memory alloy, is a pivotal feature of this device. This element confers upon the device a truly unique attribute — the innate capacity to dynamically adapt its configuration in real time, responsive to physiological conditions. Consequently, the device boasts the unparalleled capability to enact instantaneous and enduring alterations to the valve annulus. Following secure anchoring, the shape memory element gradually reverts to its predetermined memory configuration, an action that is not passive but actively exerted, directly influencing the native annulus and thereby ensuring enduring stabilization and reshaping.

[0052] The size and shape of flexible members 2, 4 are selected to fit the configuration of the mitral valve annulus. In one embodiment of the invention, flexible member 2, 4 are substantially arcuate shape and there is big gap 12 between the two members.

[0053] A plurality of anchor members, comprising barbs or prongs 26, are disposed about the exterior surface of flexible member 2, 4 and are used to attach flexible member 2, 4 to the mitral valve annulus. In one embodiment of the invention, anchor members 26 are formed by laser cutting the wall of flexible members 2, 4 or welding/soldering the anchors in such a manner as to create sharp pointed portions in a plurality of locations. These sharp pointed portions may then be shaped into anchoring barbs 26, and then manipulated so that they are oriented at an angle of 30-60 degrees in relation to the surface of flexible members 2, 4 and heat set in this open position, as seen in FIG. 5.

[0054] Flexible members 2, 4 can be transformed from its curved configuration 34 (FIG. 2) into an elongated, substantially linear configuration 30 (FIG. 8). The two ends 18, 20 may be moved in opposite directions until each flexible member 2, 4 is in an elongated, substantially linear configuration 30. Because flexible members 2, 4 comprise a shape-memory material, such as nitinol, these members 2, 4 will spontaneously revert to an unconstrained, flexible or curved configuration 34 (FIG. 9) when free to do so.

[0055] FIG. 8A is a side view of the distal portion of a delivery catheter 300 for guiding the members 2, 4 from outside the body for treating mitral valve regurgitation using minimally invasive surgical techniques, in accordance with the present invention. Flexible members 2, 4 are contained within a sheath 302 forming a delivery chamber in the distal portion of delivery catheter 300. Delivery catheter 300 is flexible, and configured so that it can be inserted into the cardiovascular system of a patient. Appropriate catheters are made of flexible biocompatible materials such as polyurethane, polyethylene, nylon and polytetrafluoroethylene (PTFE).

[0056] Flexible members 2, 4 of restraining device 200 is opened to its elongated configuration 30, FIG. 8A. Each flexible member 2, 4 of the restraining device 200 is then placed within the lumen of catheter 300 near catheter distal tip 306. Within the lumen of catheter 304, and proximal to flexible member 2, 4 of the restraining device 200 is a deployment device, such as delivery member 308. The delivery member 308 is made from a flexible material and it is used to deploy restraining device 200 by pushing it from catheter distal tip 306. In the depicted embodiment, the delivery member is a hollow member having an enlarged end portion that is adapted such that an end of the restraining device can fit therein during delivery and the be easily deployed therefrom. In the depicted embodiment, the adjustment members extending from the ends of the restraining device are routed into the delivery member during deployment of the restraining device. After restraining device 200 is deployed, the delivery member 308 may be withdrawn from catheter 304. In one embodiment of the invention, the interior surface of catheter 304 is coated with a lubricious material such as silicone, polytetrafluoroethylene (PTFE), or a hydrophilic coating. The lubricious interior surface of catheter 304 facilitates the longitudinal movement of delivery member 308 and deployment of both the members 2, 4 of the restraining device 200.

[0057] In another embodiment of the invention, sheath 302 is retractable (not shown), as is well known in the art. Sheath 302 is retracted by the surgeon to deploy device 200 from delivery catheter 304. In this embodiment, delivery member 308 or a holding means may be used to maintain device 200 in a fixed position near catheter distal tip 306 until each flexible member 2, 4 of the device 200 is deployed from the catheter.

[0058] To deliver restraining device 200 to mitral valve 4 (FIG. 3), distal tip 306 of delivery catheter 304 containing flexible members 2, 4 of device 200 is inserted into the vascular system of the patient. The catheter 304 may be inserted into the subclavian vein, through superior vena cava, and into right atrium. Alternatively, catheter tip 306 may be inserted through the femoral vein into the common iliac vein, through inferior vena cava, and into the right atrium. Next, transeptal wall between right atrium and left atrium is punctured with a guide wire or other puncturing device and distal tip 306 of delivery catheter 304 is advanced through the septal perforation and into left atrium and placed in proximity to annulus of mitral valve. Another possible delivery path would be through the femoral artery into the aorta, through the aortic valve into the left ventricle, and then through the mitral valve into left atrium. Yet another possible path would be through the left or right pulmonary vein directly into left atrium. The placement procedure, using any of these vascular routes, is preferably performed using fluoroscopic or echocardiographic guidance.

[0059] While the devices described herein can be delivered to the mitral valve annulus in a manner described above, other delivery systems and means can also be used. The delivery systems may also include a dilator catheter for providing a larger diameter pathway for delivering annulus reduction delivery system.

[0060] Next, the restraining device is deployed to the supra-valvular side/position of mitral valve 22 from the delivery catheter 304. If a catheter such as catheter 304 is used, the flexible tip 306 is moved along the surface of mitral valve annulus 16, and used to direct the placement of restraining device 200. If delivery system 300 is used, the distal tip of a suitable catheter is guided along the path. In either case, a deployment device, such as delivery member 308 within delivery catheter 304 is used to deploy flexible members 2, 4 of the restraining device 200 by pushing it from distal tip 306 of delivery catheter 304 and laying flexible restraining device 200 along mitral valve annulus 22. In yet another embodiment, sheath 302 is retracted to deploy restraining device 200.

[0061] Restraining device 200 is positioned so that anchor members 26 on the surface of restraining device 200 are facing the surface of mitral valve annulus 16. As restraining device 200 is extruded from distal tip 306 of delivery catheter 304, flexible members 2, 4 of device 200 will assume a curved, configuration 34 commensurate with mitral valve annulus 16. In addition anchor members 26 assume a deployment configuration, in which they extend away from the surface of flexible members 2, 4 at a predetermined angle.

[0062] Once restraining device 200 is secured to mitral valve annulus 16 by anchor members 26, the shape memory alloy 10 assumes its original shape so that the radius of flexible members 2, 4 and the underlying mitral valve annulus 16 are reduced by the desired amount. In one embodiment of the invention, flexible rod 308, used to deploy the restraining device 200 is withdrawn from the catheter. In one embodiment each flexible member 2, 4 of the device 200 adapt to the saddle shape 40 of the mitral valve annulus so the diameter of the to reduce the annulus diameter more efficiently.

[0063] A pivotal attribute of this invention is its unique capacity to restrict and reshape the mitral annulus, achieving a reduction in the anterior-posterior diameter. This vital alteration serves to mitigate or eliminate the dilatation responsible for valve regurgitation — an issue of substantial clinical significance. The device is meticulously configured to adapt its shape, accommodating the native saddle shape 40 of the mitral annulus 16 with exquisite precision. When deployed in tricuspid valve 38 interventions, the device plays a transformative role in resizing the septal leaflet. This strategic adjustment creates a superior coaptation of the anterior and posterior leaflets, a critical factor in ensuring optimal valve function and reducing regurgitation.

[0064] In a specific embodiment, when added strength and flexibility are required for stabilizing the valve annulus 16 in an expanded state, the first flexible member 2 can be utilized in conjunction with the second flexible member 4 to establish a closed geometric shape by connecting the corresponding first and second ends of each flexible member. This particular design choice empowers the stabilizing device 200 to provide augmented structural integrity and support precisely suited to the distinct demands of stabilizing a dysfunctional heart valve.

[0065] Within this arrangement, the first end of the first flexible member 2 is affixed to the first end of the second flexible member 4, and the second end of each member are similarly connected. The second flexible member 4 forms an arch 50 over the first flexible member 2, maintaining an angle between 45° and 135°, as illustrated in FIG. 21. This seamless integration exemplifies the device's inherent adaptability and flexibility, showcasing its ability to adapt to diverse anatomical conditions and furnish optimal support. The stabilizing arch 50 imparts additional structural strength and enhanced flexibility, further enhancing the device's ability to accurately follow the dynamic expansion movements and fluctuations in the anatomical configuration of the valve annulus. This feature represents a pioneering approach to ensuring optimal performance in a diverse range of anatomical contexts, enhancing the device's versatility and applicability.

[0066] One of the distinctive characteristic applications of the flexible restraining device (annuloplasty device) 200 lies in its seamless integration with the implantation of a mitral clip 60, as shown in FIG. 22, a widely utilized interventional tool for mitral valve repair. The mitral clip 60 is a well-established interventional tool used extensively for mitral valve repair. It excels in securing the middle portion of both leaflets of the mitral valve, akin to a clothespin. However, it often falls short in comprehensively addressing later dilatation that can manifest on the lateral part of the mitral annulus 16. These critical zones 62, 64 surrounding the mitral clip 60, positioned at the central aspect of the valve, is susceptible to subsequent dilation, thereby potentially compromising the long-term success of the procedure. The integration of the lateral devices (flexible members 2,4) on both sides of the annulus 16 presents a transformative solution, elevating and optimizing the long-term success rate of the mitral clip procedure.

[0067] In another embodiment the flexible restraining device (annuloplasty device) 200 can have features or components designed to make the process of anchoring more efficient and effective when it is done from a distance, possibly through some form of remote control or automated system allowing a more sophisticated implantation.

[0068] The person skilled in the art will appreciate the following improvements to the presently available heart valve annulus stabilizing:

Innovative Design

[0069] The heart valve annulus stabilizing, restraining, and reshaping device introduces a novel approach to cardiovascular interventions. Comprising two separate elastic elements 2, 4, each embodying half of a D-shaped configuration, the device offers precise control over annular dimensions without exerting force or deformity on surrounding anatomical structures. Percutaneously delivered and positioned laterally on either side of the mitral or tricuspid valves, it effectively addresses lateral dilatation, particularly on the supra-annular side.

B. Dynamic Adaptation with Shape Memory Alloy

[0070] The incorporation of a shape memory element 10 enables dynamic configuration adaptation, ensuring enduring stabilization and reshaping of the valve annulus. This innovative feature allows the device to respond in real-time to physiological conditions, providing unparalleled flexibility and effectiveness in valvular interventions.

C. Enhanced Mitral Clip Integration [0071] This innovative device also integrates seamlessly with the implantation of a mitral clip

60, enhancing the long-term success of mitral valve 22 repair procedures. By addressing critical zones surrounding the mitral clip 60, it elevates and optimizes the overall procedure's success rate.

D: Stabilizing Arch for Adaptability [0072] The introduction of a stabilizing arch 50 further augments the device's adaptability and flexibility. This feature represents a pioneering approach to ensuring optimal performance in a diverse range of anatomical contexts, enhancing the device's versatility and applicability.

Claims

WHAT IS CLAIMED IS: CLAIMS

1. A stabilizing device to restrain a heart valve annulus comprising: a first half D-shaped flexible member comprising a first end, a second end, a shape memory element, and a plurality of anchoring portions; a second half D-shaped flexible member comprising a first end, a second end, a shape memory element, and a plurality of anchoring portions; wherein the shape memory element in the first and the second half D-shaped flexible members consists of at least one shape memory material extending up to half length of each flexible member; and wherein presence of a shape memory element within the first and the second half D-shaped flexible members are positioned laterally around the heart valve annulus, for flexibility and effective stabilization of the heart valve in expansion state and in contraction state.

2. The stabilizing device of claim 1, wherein the first and the second flexible members are separate and are positioned at a distance from each other.

3. The stabilizing device of claim 1, wherein the first and the second flexible members are configured to accommodate a multitude of configurations.

4. The stabilizing device of claim 1, wherein the shape memory element allows the flexible members to change from a first geometric configuration to a second geometric configuration by direct or continuous transition.

5. The stabilizing device of claim 1, wherein the stabilizing device forms a substantially arcuate shape when at least one shape memory element is in the second geometric configuration.

6. The stabilizing device of claim 5, wherein the shape memory element comprises a shape memory alloy.

7. The stabilizing device of claim 5, wherein the shape memory element comprises a shape memory polymer.

8. The stabilizing device of claim 3, wherein the first and the second flexible members are configured to adapt to a saddle shape of a mitral valve annulus, including 2-dimensional and 3 -dimensional deformation of variable degrees.

9. The stabilizing device of claim 3, wherein the first and the second flexible members are configured to adapt to a shape of a tricuspid valve annulus, including 2-dimensional and 3- dimensional deformation of variable degrees.

10. The stabilizing device of claim 9, wherein one of the flexible members forms an arch over another flexible member to enhance flexibility and effective stabilization of the device in both expansion and contraction states.

11. The stabilizing device of claim 1 further comprises at least one fixation member configured to substantially anchor the stabilizing device within the valve annulus or a paravalvular portion, including leaflets of the valve.

12. The stabilizing device of claim 1, wherein the first flexible member and the second flexible member are joined together to form a closed geometric shape for additional strength, flexibility and to stabilize the valve annulus in the expansion state.

13. A method for stabilizing heart valve annulus, comprising: inserting a first half D-shaped flexible member of a heart valve annulus adjusting device into a patient's body via body lumen in a reduced state and can be extended when within a desired body cavity; inserting a second half D-shaped flexible member of the heart valve annulus adjusting device into the patient's body via body lumen in a reduced state and can be extended when within the desired body cavity; positioning the first and the second half D-shaped flexible members laterally around the heart valve annulus; anchoring the first and the second D-shaped flexible members to the valve annulus; extending the device within the desired body cavity; and configuring the device from a first geometric configuration to a second geometric configuration by direct or continuous transition using a shape memory element.

14. The method of claim 13, wherein said flexible members are substantially straight in the first geometric configuration.

15. The method of claim 13, wherein the device is configured to exert a force on the valve annulus when the shape memory element is in the second geometric configuration.

16. The method of claim 13, wherein the device is configured to exert a continuously increasing force on the valve annulus when changing from the first to the second geometric configuration.

17. The method of claim 13, wherein the device ensures that the shape memory element within both the first and the second D-shaped flexible members to effectively stabilize the valve annulus in both expansion state and in contraction state.

18. The method of claim 13, wherein the device is implanted through endovascular, percutaneous, transcatheter, and open surgical approaches.

19. The method of claim 13, wherein the device incorporates a mechanism designed to facilitate remote anchoring procedures.

20. A stabilizing device to restrain a heart valve annulus consisting: a half D-shaped flexible member comprising a first end, a second end, a shape memory element, a plurality of anchoring portions; wherein the shape memory element in the flexible member consisting of at least one shape memory material extending at least half length of each flexible member; and wherein presence of the shape memory element within the flexible member, positioned laterally around the heart valve annulus, contributes to flexibility and effective stabilization of the device in both expansion and contraction states.