Heart valve prosthesis delivery system

Abstract

An artificial heart valve delivery device may include an engagement mechanism that can reliably engage with and disengage the heart valve prosthesis it delivers. The delivery device may have a docking area defining a longitudinal axis and an engagement wire extending along the longitudinal axis. The engagement wire may have an engagement position where it extends through the docking area to engage with the heart valve prosthesis. The engagement wire may also move to a disengagement position to allow disengagement of the heart valve prosthesis from the docking area.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Provisional Application No. 63 / 455,943, filed Mar. 30, 2023, which is related to International Application No. PCT / US2019 / 012406, filed Jan. 4, 2019, and International Application No. PCT / US2019 / 012408, filed Jan. 4, 2019, the entire contents of each of which are incorporated herein by reference.

[0002] [Technical Field] The present disclosure relates to devices, systems, and methods for percutaneous delivery and implantation of heart valve prostheses. The valve delivery device can maintain a compressed state within a sheath for delivery to and secure release at a damaged native valve.

Background Art

[0003] Artificial heart valves are used to replace damaged or diseased heart valves. In vertebrates, the heart is a muscular organ having four pumping chambers, namely, a left atrium and a right atrium, each with its own one - way valve, and a left ventricle and a right ventricle. Natural heart valves are identified as the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. Artificial heart valves can replace any of these naturally occurring valves, but the aortic or mitral valves are more commonly repaired or replaced because they are on the left side of the heart where the pressure is highest.

[0004] Conventional heart valve replacement procedures involve accessing the heart within the patient's chest cavity through a median sternotomy. For example, in a median sternotomy, the sternum is cut open, and the two opposing halves of the chest wall must be forcibly spread apart to gain access to the chest cavity and the heart within it. The patient is then placed on cardiopulmonary bypass, which involves stopping the heart to allow access to the inner chambers. Such open - heart surgeries are particularly invasive and involve a long and difficult recovery period.

[0005] The aforementioned embodiments of the related technology and the limitations relating thereto are intended to be illustrative and non-exclusive. Other limitations of the related technology will become apparent to those skilled in the art through reading this specification and studying the drawings. [Overview of the Initiative]

[0006] This disclosure relates to a cardiac valve prosthesis, a delivery device, and an operating handle, which can facilitate the delivery of the cardiac valve prosthesis to a patient's defective natural valve structure, such as the vena cava valve. In some embodiments, delivery can be performed using a transcatheter approach.

[0007] The delivery devices disclosed herein can enable clinicians to more easily deliver and disengage the heart valve prostheses they deliver. The delivery devices can advance through blood vessels leading to the heart, and through the tortuous nature of such vessels, using transvascular approaches such as transfemoral approaches. According to at least some embodiments disclosed herein, when advancing a heart valve prosthesis to a target location within the heart, the delivery device needs to provide a secure engagement between the delivery device and the heart valve prosthesis, but it must also be able to reliably disengage from the heart valve prosthesis at the target location and release the prosthesis without causing any trauma to natural tissue or damage to the heart valve prosthesis itself. Furthermore, this recognition points out that very few delivery devices successfully balance these conflicting needs. Therefore, this disclosure provides a significant advance in addressing these and other issues and ensuring safety and reliability in the operation of heart valve delivery devices.

[0008] An artificial heart valve delivery device may include an engagement mechanism that can reliably engage with and disengage the heart valve prosthesis it delivers. The delivery device may have a docking area defining a longitudinal axis and an engagement wire extending along the longitudinal axis. The engagement wire may have an engagement position where it extends through the docking area and engages with the heart valve prosthesis. The engagement wire may also move to a disengagement position to allow disengagement of the heart valve prosthesis from the docking area.

[0009] According to some embodiments, procedures for transcatheter aortic valve implantation (TAVI) and / or transcatheter aortic valve replacement (TAVR) are provided. For example, in a TAVI procedure, a clinician may anchor the valve anchor of a valve prosthesis to the aortic annulus to guide the placement of the prosthetic valve leaflet structure. The valve prosthesis may comprise prosthetic valve leaflets, a valve anchor, a valve frame component, and a tethering component, which allows the valve anchor and frame component to be arranged in series within the delivery device to reduce the overall cross-profile of the delivery device. According to some embodiments, the valve anchor may be coupled to one or more gripping mechanisms of the delivery device. The gripping mechanism may be configured to include one of the various specific structures disclosed herein, which securely engage with a portion of the valve anchor and allow for reliable release of the valve anchor therefrom.

[0010] Additional embodiments of the device and method, and similar devices, will be apparent from the following description, drawings, examples, and claims. As can be understood from the foregoing and the following description, each and every feature described herein, and each and every combination of two or more such features, are included within the scope of the disclosure, provided that the features included in such combination are not inconsistent with each other. In addition, any feature or combination of features may be specifically excluded or omitted from any embodiment of the disclosure. Additional aspects and advantages of the disclosure are described in the following description and claims, particularly in conjunction with the appended examples and drawings.

[0011] Additional features and advantages of the subject art are described below and may be partially evident from the description or learned through the practice of the subject art. The advantages of the subject art will be realized and achieved through the written description and embodiments of this specification and the structures particularly indicated in the accompanying drawings.

[0012] Certain features of valve prostheses, delivery devices, operating handles, other devices, systems, and methods that can be implemented using the valve prostheses, delivery devices, operating handles, other devices, systems, and methods considered in this disclosure can implement, and / or be used in combination with, the features of valve prostheses, delivery devices, operating handles, other devices, systems, and methods described, for example, in International Applications PCT / US2019 / 012406 and PCT / US2019 / 012408, filed on January 4, 2019.

[0013] It should be understood that both the general description above and the detailed description below are illustrative and explanatory, and are intended to provide further explanation of the subject technology.

[0014] Various features of illustrative embodiments of the present invention are described below with reference to the drawings. The illustrative embodiments are intended to illustrate, but not to limit, the present invention. The drawings include the following figures. [Brief explanation of the drawing]

[0015] [Figure 1] We illustrate the delivery of a valve prosthesis using a valve delivery device via a transfemoral retrograde approach in some embodiments. [Figure 2] A valve prosthesis according to some embodiments is shown. [Figure 3] This is a partial side cross-sectional view of the valve prosthesis shown in Figure 2, loaded onto a valve delivery device according to one embodiment. [Figure 4] Figure 2 is a perspective view of a valve delivery device showing a gripping mechanism in an expanded state, engaged with a valve anchor, according to one embodiment. [Figure 5A] Figure 3 is an enlarged perspective view of a valve delivery device, showing a gripping mechanism for engaging with a valve anchor, according to one embodiment. [Figure 5B] Figure 3 is an enlarged perspective view of a valve delivery device, showing a tubular member of a gripping mechanism with dashed lines to illustrate the internal components of the gripping mechanism according to some embodiments. [Figure 6A] This is a cross-sectional view of the valve delivery device shown in Figure 5A, according to one embodiment. [Figure 6B] This is a cross-sectional view of the valve delivery device shown in Figure 5A, according to one embodiment. [Figure 7A] The disengagement process of the valve delivery device shown in Figure 5A, according to one embodiment, is illustrated as an example. [Figure 7B] The disengagement process of the valve delivery device shown in Figure 5A, according to one embodiment, is illustrated as an example. [Figure 7C] The disengagement process of the valve delivery device shown in Figure 5A, according to one embodiment, is illustrated as an example. [Figure 7D] The disengagement process of the valve delivery device shown in Figure 5A, according to one embodiment, is illustrated as an example. [Figure 8]Illustrate an alternative gripper mechanism in an engaged state, according to some embodiments. [Figure 9] Illustrate another gripper mechanism in an engaged state, according to some embodiments. [Figure 10] Illustrate yet another gripper mechanism in an engaged state, according to some embodiments. [Figure 11] Illustrate yet another gripper mechanism, according to some embodiments. [Figure 12A] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 12B] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 12C] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 12D] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 12E] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 13] Illustrate yet another gripper mechanism in a disengaged state, according to some embodiments. [Figure 14] Illustrate yet another gripper mechanism in an engaged state, according to some embodiments. [Figure 15A] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 15B] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 16A] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 16B] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Figure 17] Illustrate yet another gripper mechanism and its disengaging process, according to some embodiments. [Modes for carrying out the invention]

[0016] The following detailed explanation includes numerous specific details to provide a complete understanding of the subject art. It should be understood that the subject art can be practiced even without these specific details. In other examples, well-known structures and techniques are not shown in detail so as not to obscure the subject art.

[0017] Furthermore, while this disclosure describes specific details of various embodiments, it will be understood that the descriptions are illustrative only and should not be construed as limiting in any way. In addition, while certain embodiments of this disclosure may be disclosed or shown in the context of vena cava valve prostheses, such embodiments are intended to be used for other cardiac valve prosthesis applications. Moreover, various applications of such embodiments and their modifications that may arise for those skilled in the art are also encompassed by the general concepts described herein.

[0018] Various embodiments are described in more detail below. However, such embodiments may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided so as to make this disclosure detailed and complete and to fully convey the scope of the invention to those skilled in the art. Therefore, one or more features shown or otherwise disclosed in the embodiments herein may be used or incorporated interchangeably in other embodiments that do not expressly show or disclose such features. Furthermore, one or more features shown or otherwise disclosed in the embodiments herein may be excluded from such embodiments by means of the art unless expressly indicated.

[0019] Like all heart valves, a healthy aortic valve opens to allow blood flow and closes to prevent blood from flowing backward. However, valve disease and dysfunction can lead to backflow or reduced blood flow (stenosis). In such cases, a replacement aortic valve prosthesis must be used to perform the function of a healthy aortic valve.

[0020] Minimally invasive surgical techniques are evolving, and valve prostheses can now be delivered to patients using catheters introduced, for example, through small incisions in the femoral artery or directly into the heart. These implantation techniques have shown promising results in providing treatment options for patients who are not candidates for open surgery. Nevertheless, challenges remain in such catheter-based delivery of prosthetic valves.

[0021] For example, according to an aspect of at least one embodiment disclosed herein, it is recognized that advancing a conventional tubular delivery device through a vessel puts stress on the vessel wall and carries the risk of damaging the vessel wall. Furthermore, according to an aspect of at least one embodiment disclosed herein, it is recognized that transcatheter prosthetic valves may not be able to treat patients with aortic regurgitation. In addition, according to an aspect of at least one embodiment disclosed herein, it is recognized that conventional prosthetic valves may be difficult to position, may require rapid ventricular pacing, and may have limited expansion. Therefore, the implantation and use of conventional prosthetic valves may result in complications such as vascular damage, moderate to severe paravalvular leakage, valve thrombosis / migration, coronary artery occlusion, and excessive stress due to excessive radial force.

[0022] This disclosure describes various embodiments of heart valve prostheses that can be delivered to a patient's defective heart valve. A valve prosthesis may comprise at least one valve anchor that is movably connected, movably mounted, flexibly connected, displaceably connected, coupled, or joined to a radially expandable valve support or frame. The valve frame may comprise the valve leaflets or spires of the artificial valve and provide the function of a natural heart valve. Certain features of valve prostheses that can be implemented using the prostheses considered in this disclosure are also described, for example, in U.S. Patent No. 8,366,768, which is incorporated herein by reference in whole.

[0023] Therefore, this disclosure provides a variety of features that can be optionally incorporated or excluded from any of the embodiments expressly considered or illustrated herein. Combinations of these modifications and features can be implemented by those skilled in the art to achieve the advantages and benefits considered herein. Furthermore, while certain modifications or combinations are shown or suggested herein, it is intended that those skilled in the art can implement or exclude certain features or aspects disclosed herein when developing preferred embodiments or implementations of these teachings. Advantageously, the various embodiments described herein enable the treatment of patients with aortic regurgitation, allow for precise axial, angular, and radial positioning of valve prostheses, minimize valve movement and perialiflux while avoiding damage to the annulus, minimize the need for pacemakers, and reduce the likelihood of coronary artery occlusion.

[0024] Some of these features and benefits of cardiac valve prostheses and their delivery systems are illustrated with reference to Figures 1-4. Figure 1 illustrates the use of a delivery device in a human heart 10. The heart 10 may comprise an aorta 12 having an aortic arch 14 and an aortic valve 16. The aortic valve 16 comprises a plurality of natural valve leaflets 18 and can separate the aorta 12 from the left ventricle 20. According to some embodiments, a clinician can operate a handle actuator 50 to control the delivery and release of the valve prosthesis 100. The valve prosthesis 100 can be carried by the delivery device and advanced retrogradely through the aorta 12 until it reaches and is positioned through the natural valve leaflets 18 of the aortic valve 16.

[0025] Referring to Figures 1 and 2, during delivery of the valve prosthesis 100 to the natural valve site, the support frame 102 and valve anchor 104 of the prosthesis 100 can be positioned in series as a unit axially displaced along the longitudinal axis of the delivery device 200 (with or without partial or complete overlap between the anchor and the frame). This configuration, in contrast to concentric arrangement, allows for a more radially compact configuration of the components of the valve prosthesis 100, creating a much smaller cross-section and facilitating catheter-based delivery. This improves the flexibility of the delivery device 200, allowing it to advance on the guidewire through the circulatory system, particularly the curvilinear shape of the aortic arch 14. Indeed, even with guidewire-guided delivery devices, the aortic arch 14 presents a challenging obstacle due to its sharp and highly curvilinear nature. Often, this is a limiting constraint for certain surgeries or delivery devices. However, according to the various benefits and advantages of some embodiments disclosed herein, as illustrated in Figure 1, the delivery device 200 can advance over the aortic arch 14 to a target location within the region of the aortic valve 16.

[0026] As shown in Figure 1, when the valve anchor 104 is in the desired position, the support frame 102 is released from the distal carrier assembly and expands to align with the leaflets 18 of the natural valve and the inner surface of the valve anchor 104, thus allowing the leaflets 18 of the natural valve to be sandwiched between the support frame 102 and the valve anchor 104. Advantageously, by sandwiching the leaflets 18 of the natural valve between the support frame and the valve anchor, the valve prosthesis 100 can reduce its reliance on holding radial forces. Furthermore, by sandwiching the leaflets 18 of the natural valve between the support frame and the valve anchor, the possibility of the leaflets 18 obstructing the coronary artery opening is reduced, which may be beneficial for patients with short coronary artery orifice distances and patients who may require a new valve prosthesis within an existing valve prosthesis (valve-in-valve application). Thus, the support frame and valve anchor can expand to contact the aortic valve 16 and exert a sustained outward force on the leaflets 18 of the natural valve and the aortic annulus 22. Subsequently, the valve leaflets of the prosthesis 100 artificial valve begin to function in the desired manner and can provide the same operation as a natural valve.

[0027] According to some embodiments, the Disclosure also provides a handle actuator that can be used to control the operation of the delivery device of the Disclosure, enabling a clinician to reliably and accurately control the delivery of a valve prosthesis. Figure 1 illustrates the features and operation of a handle actuator 50 that can be operated to deliver a valve prosthesis according to some embodiments.

[0028] Figure 1 illustrates a handle actuator 50 capable of controlling one or more functions of a delivery device (e.g., a delivery device 200 discussed herein) for delivering a valve prosthesis (e.g., a cardiac valve prosthesis 100 discussed herein). The handle actuator 50 may comprise a plurality of actuators or movable elements, such as knobs or buttons. The movable elements may enable a clinician to control one or more operations of the delivery device 200. The handle actuator 50 may comprise a control handle 52 having a longitudinal axis 54. The handle actuator 50 may also be referred to as a control unit. In some embodiments, the handle actuator 50 may be coupled to a second core member (e.g., shown in Figure 3). The control handle 52 supports the actuator and can be held by a clinician during a procedure.

[0029] In some embodiments, as illustrated in Figure 1, the handle actuator 50 may comprise a first movable element 56, a second movable element 58, a third movable element 60, and a fourth movable element 62. The first movable element 56 can be used to guide the delivery device 200, the second movable element 58 can be used to release the valve anchor, the third movable element 60 can be used to release the nose cone or valve frame, and the fourth movable element 62 can be used as a toggle lock for the nose cone. The first movable element 56, the second movable element 58, the third movable element 60, and the fourth movable element 62 may also be referred to as the first control element 56, the second control element 58, the third control element 60, and the fourth control element 62.

[0030] Optionally, in some embodiments, one or more of the movable elements, such as a second movable element 58 and / or a third movable element 60, may include a button or slider safety switch 64 to prevent unintended rotation of the movable element. The safety switch 64 may be configured as an elastic button or slider mechanism that can be actuated to release a lock that provides resistance to rotational or translational movement of each movable element. In some embodiments, the movable elements may have raised features that provide visual and tactile indication of their rotational position, so that the user does not need to look at the device to operate it, which facilitates tactile engagement and operation by a clinician. Other features of the handle actuator 50 and methods for operating the handle actuator 50 are discussed and illustrated in U.S. Patents 11,090,156 and 11,083,577, each of which is incorporated herein by reference in whole.

[0031] Referring here to Figure 2, the valve prosthesis 100 and its components are shown in various configurations. The valve prosthesis 100 can be delivered to a patient using a suitable delivery device, including embodiments of delivery devices disclosed herein. The valve prosthesis 100 may comprise a support frame 102 and a valve anchor 104 to which the support frame 102 is movably connected, movably mounted, elastically connected, displaceably connected, coupled, or joined.

[0032] The valve prosthesis 100 can be configured such that its components are still movably connected, movably mounted, elastically connected, displaceably connected, coupled, or joined to each other and advance sequentially, thereby minimizing the passage profile or cross-sectional area of ​​the delivery system. The interconnections of the components of the valve prosthesis 100 can allow for different degrees of movement and can be set to an engaged position or a retained position that provides a limited range of movement. In some embodiments, the engaged position can also provide a pre-set relative positioning of the components of the valve prosthesis 100 to facilitate proper placement and release of the valve prosthesis 100. In addition, some embodiments can provide clinicians with a high degree of control when implanting the valve prosthesis 100 at the target site, thereby enhancing the operability of the valve prosthesis 100.

[0033] In some embodiments, the valve anchor 104 can be coupled to the support frame 102 when the support frame 102 is in a compact configuration before delivery and expansion. In some embodiments, the valve anchor 104 is not fixed to the support frame 102. Furthermore, the valve anchor 104 can be separated from the support frame 102 or formed separately from the support frame 102 and then coupled. Thus, although at least a portion of the valve anchor 104, such as the anchor leg, may be in contact with or reversibly attached to the support frame 102, no portion of the valve anchor 104 is fixed to the support frame 102, for example, by welding or otherwise irreversibly bonded. In other words, the valve anchor 104 may be in contact with or otherwise reversibly attached to the support frame 102, but it is not irreversibly fixed to the support frame 102.

[0034] Furthermore, upon reaching the target location, the valve anchor 104 can be movably coupled to the support frame 102 in such a manner that it prevents the entire valve anchor 104 from being radially displaced from the support frame 102 when the valve anchor 104 is first extended. For example, a portion of the valve anchor 104 may be radially displaced from the support frame during the initial "landing" of the valve anchor 104 onto the natural valve structure at the target location. In some embodiments, the support frame 102 can be deployed or extended within the natural heart valve structure, and the valve anchor 104 can be sandwiched between the support frame and the natural valve tissue, and at least partially, and possibly completely, fixed in place. The valve anchor 104 can function to hold the extended support frame 102 in place within the natural valve structure.

[0035] Optionally, the support frame 102 may be referred to as a valve frame or valve support frame. Figure 2 illustrates a support frame 102 aligned with and expanded within a valve anchor 104, a configuration achieved when the prosthesis 100 is released and expanded within a natural valve structure. The natural valve structure includes annulus or leaflets. This expanded configuration serves to secure the valve prosthesis 100 within the natural annulus by engaging with the natural valve structure. In some embodiments, the expanded configuration of the valve prosthesis 100 can reduce reliance on securing the valve prosthesis 100 by radial forces exerted by the support frame 102 and valve anchor 104 through pinching or compression of the leaflets of the natural valve between the support frame 102 and the valve anchor 104 of the valve prosthesis 100. Furthermore, as will be further discussed herein, during the implantation of the valve prosthesis 100, the support frame 102 and valve anchor 104 may be movable relative to each other in an expanded and / or compressed state to facilitate proper positioning of the prosthesis 100 relative to the natural valve annulus and surrounding structures. In fact, the various advantages enabled by the prosthesis 100 delivery device disclosed herein will enable clinicians to achieve greater precision in the placement of the prosthesis 100, and to achieve such improvements in precision more easily.

[0036] Referring to Figure 2, the support frame 102 may have an outer or external surface and define a central orifice around a longitudinal axis 120. The longitudinal axis 120 corresponds to the inlet-outlet axis of the prosthesis 100. In some embodiments, the valve prosthesis 100 further comprises a plurality of artificial valve leaflets or spires 106 coupled to the support frame 102. The support frame 102 can provide a structural support for the valve leaflets 106. The valve leaflets 106 may have a surface that defines a reversibly sealable opening for unidirectional flow of fluid through the prosthesis 100. The prosthesis 100 may include three valve leaflets 106 for a three-leaflet configuration. As understood, single-leaflet, two-leaflet, and / or multi-leaflet configurations are also possible. For example, the valve leaflets may be coupled to the support frame 102 to control the flow of fluid through the lumen of the prosthesis 100. The artificial valve leaflet 106 may include one or more synthetic materials, modified biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically treated / processed tissues, or combinations thereof. In some embodiments, the pericardial tissue is selected from, but is not limited to, the group consisting of bovine, horse, pig, sheep, human tissues, or combinations thereof.

[0037] Furthermore, in some embodiments, the valve prosthesis 100 may include a sealing component or membrane 108 that can be attached to the inner surface, the outer surface, and / or surround the support frame 102, such as by being laminated on the inner and outer surfaces of the support frame 102. Thus, the valve leaflets 106 can be coupled to the support frame 102 and / or the membrane 108. In some embodiments, the membrane 108 can restrict blood flow in the area around the valve leaflets 106 so that blood flow occurs only between the valve leaflets 106 through the lumen of the prosthesis 100, as in a healthy natural heart valve.

[0038] The support frame 102 and / or valve anchor 104 may include a braided frame, a wire frame, or a laser-cut frame (e.g., a laser-cut tubular mesh), as shown in Figure 2. In some embodiments, the support frame 102 and / or valve anchor 104 may include a shape memory metal that can change shape at a specified temperature or temperature range, or by inducing stress. Alternatively, the self-expanding frame may include a frame with a spring bias. The material from which either the support frame 102 and / or valve anchor 104 is fabricated may allow the support frame 102 and / or valve anchor 104 to automatically expand to its functional size and shape when deployed, but may also allow the support frame 102 and / or valve anchor 104 to be radially compressed to a smaller profile for delivery through the patient's vascular system. Examples of preferred materials for the self-expanding components described herein (e.g., support frame, valve anchor, locking member) include, but are not limited to, medical-grade nickel-titanium alloys, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginates, or combinations thereof. Generally, shape memory alloys having superelastic properties, made from a nickel-titanium ratio known as nitinol, are preferred materials. In some embodiments, the self-expanding components described herein may include, but are not limited to, shape memory plastics, polymers, and thermoplastic materials that are inert in the body. In alternative embodiments, either the support frame 102 and / or the valve anchor 104 may be expanded using, for example, a balloon catheter well known in the art, rather than self-expanding. Examples of materials preferred for the components described herein include, but are not limited to, stainless steel and titanium. Optionally, either the support frame 102 and / or the valve anchor 104 may include a radiopaque material to allow visualization under fluoroscopy or other imaging techniques.

[0039] Optionally, the support frame 102 may include one or more hooks 109 that can engage with the tissue of the natural valve annulus, the aortic root, or any other part of the natural valve when the support frame 102 is expanded within the natural valve annulus. The hooks 109 can engage with the natural valve annulus to secure the prosthesis 100 and reduce the movement of the prosthesis 100 downstream or antegrade during operation.

[0040] The support frame 102 may include a first end portion 110 and a second end portion 112. The first end portion 110 may be positioned upstream of the second end portion 112 when the prosthesis 100 is released into the natural valve annulus. As illustrated in Figure 2, the first end portion 110 of the support frame 102 may be shaped as a generally flat end of a cylinder, and the first apex 114 of the support frame 102 may be roughly on a common plane that can be oriented substantially perpendicular to the longitudinal axis 120 of the prosthesis 100. Furthermore, the second end portion 112 may be shaped to include a series of peaks 130 and valleys 132, and the second apex or small peaks 136 of the support frame 102 collectively form the contour of the peaks 130 and valleys 132. The peaks 130 and valleys 132 of the second end portion 112 may be positioned downstream of the first end portion 110 when the prosthesis is placed into the natural valve annulus.

[0041] According to some embodiments, the artificial valve leaflet 106 can be bonded to the support frame 102 at a location circumferentially aligned with the ridge 130 of the second end portion 112, as shown in Figure 2. In some embodiments, the artificial valve leaflet 106 can be bonded to the membrane 108 using, for example, ultra-high molecular weight polyethylene sutures. This unique configuration is advantageous because it allows the prosthesis 100 to more closely approximate the natural valve structure, enabling more natural blood flow without restricting or otherwise constraining the movement of the valve leaflet 106, and allowing for more seamless integration with the surrounding structures of the heart. In some embodiments, the artificial valve leaflet 106 may include, but is not limited to, planar features, flat features, three-dimensional features, Bézier curves, or other preferred shapes. Optionally, the artificial valve leaflet 106 can be molded through fixation on a leaflet-shaped mandrel.

[0042] The valve anchor 104 may include at least one U-shaped member, sinus locator, valve positioner, or valve hanger 140 extending around the longitudinal axis of the valve anchor 104. As illustrated in Figure 2, the valve anchor 104 may include multiple lobes or U-shaped members 140, such as three U-shaped members 140, but may include fewer or more. In some embodiments, the U-shaped members 140 may be configured to engage with or fit into the posterior vena cava sinus, left vena cava sinus, and right vena cava sinus of the natural vena cava valve. Each U-shaped member 140 may have a crest portion 142 and a base portion 144. Each U-shaped member 140 may have first and second legs 146, 148. The first and second legs 146, 148 of adjacent U-shaped members 140 may be interconnected at their crest portions 142. Furthermore, the U-shaped member 140 may include shapes other than U-shape, such as wave-shaped, V-shaped, W-shaped, or zigzag. Optionally, each of the multiple valve anchors 104 may comprise one or more U-shaped members 140, and the multiple valve anchors 104 cooperate with the aortic sinus to secure the valve prosthesis as described herein.

[0043] The valve prosthesis 100 may include a link mechanism 160 that interconnects the support frame 102 to the valve anchor 104. The link mechanism 160 may include a single continuous strand of material or multiple independent strands of material that interconnects the support frame 102 to the valve anchor 104. Furthermore, the link mechanism 160 may be attached in one or more locations on the support frame 102 and / or the valve anchor 104 in the manner of sliding, engaging, or fixing.

[0044] In some embodiments, the valve anchor 104 may optionally define one or more engagement areas on one or more portions of the valve anchor 104, and the link mechanism 160 may engage with one or more engagement areas to restrict relative movement between the support frame 102 and the valve anchor 104.

[0045] For example, at the interconnection of each peak, the valve anchor 104 can define an engagement area 150. The engagement area 150 may also be referred to as the peak engagement area.

[0046] As illustrated in Figure 2, the support frame 102 can be flexibly coupled to the valve anchor 104 via one or more link mechanisms 160. The link mechanism 160 can be coupled to the support frame 102 and the valve anchor 104, allowing relative movement between the support frame 102 and the valve anchor 104. However, the link mechanism 160 can be configured to restrict relative movement between the support frame 102 and the valve anchor 104. In some embodiments, the engagement area 150 of the valve anchor 104 can be used to further restrict the relative movement of the support frame 102 with respect to the valve anchor 104 when the link mechanism 160 is engaged with the engagement area 150, as discussed herein.

[0047] Therefore, the valve anchor 104 can be coupled to the support frame 102, allowing the valve anchor 104 to move axially or longitudinally relative to the support frame 102, while remaining coupled to the support frame 102. This advantageous feature in some embodiments allows a clinician to independently position the valve anchor 104 relative to the support frame 102. For example, in transcatheter vena cava valve replacement, the clinician can independently position the valve anchor 104 to fit its base portion 144 into the vena cava sinus. The portions of the vena cava sinus may include the posterior vena cava sinus, left vena cava sinus, and / or right vena cava sinus of the natural vena cava valve. In some embodiments, the valve anchor 104 can be rotated to align within each aortic sinus. In some embodiments, the interconnection of the valve anchor 104 to the support frame 102 can allow the valve anchor 104 to rotate or reposition, such as by self-rotation, to align within or relative to the aortic sinus. The longitudinal and rotational movement of the valve anchor 104 can be facilitated through the interconnection of the engagement area 150 of the valve anchor 104 with a controlled member or gripper of the delivery device, as will be further discussed below.

[0048] With the valve anchors 104 "landed" in their respective aortic sinuses, the interconnection between the valve anchors 104 and the support frame 102 further allows the support frame 102 to translate along the longitudinal axis 120 of the valve prosthesis 100. In some embodiments, during the delivery procedure, the valve anchors 104 can be moved at least axially from a proximal position relative to the support frame 102 to a distal position relative to the support frame 102, or from either of these positions to a position where the support frame 102 at least partially overlaps the valve anchors 104 longitudinally or is concentric within the valve anchors 104. A range of various positions is illustrated, for example, in U.S. Patents 11,090,156 and 11,083,577, each of which is incorporated herein by reference in its entirety.

[0049] For example, as shown in Figure 2, when the support frame 102 is nested within the valve anchor 104, the base portion 144 of the valve anchor 104 can be longitudinally spaced away from the first end portion 110 of the support frame 102 along the longitudinal axis 120 at distances of approximately 10% to 100%, 25% to 75%, 33% to 100%, 33% to 66%, 25% to 75%, 50% to 75%, or 60% to 70% of the length of the support frame 102. In some embodiments, the support frame 102 can be housed within the valve anchor 104 or otherwise completely overlap it. In some embodiments, the support frame 102 may have minimal or no overlap with the valve anchor 104. The support frame 102 can move along the longitudinal axis 120 so that it overlaps the valve anchor 104 by about 10% to about 100%, about 25% to about 75%, about 33% to about 100%, about 33% to about 66%, about 25% to about 75%, or about 50% to about 75% of the length of the support frame 102. According to some embodiments, the U-shaped member 140 of the valve anchor 104 may be in a nested position within the aortic sinus, and the base portion 144 of the valve anchor 104 may be substantially longitudinally adjacent to and coplanar with the first end portion 110 of the support frame 102, or spaced apart from it. For example, the valve anchor 104 may be in a nested position when at least one base portion 144 of the valve anchor 104 is in contact with or adjacent to the base attachment portion of the leaflet of the natural vena cava valve. Furthermore, the first end portion 110 of the support frame 102 may be adjacent to, on the same plane as, the natural valve structure (or the virtual ring formed by the base attachment portion of the natural aortic valve leaflet) or the ventricular-aortic junction, or spaced apart in the longitudinal direction.

[0050] The link mechanism 160 can enable rotation and longitudinal movement of the valve anchor 104 relative to the support frame 102. Therefore, despite the presence of the link mechanism 160, the valve anchor 104 can move rotationally relative to the support frame 102. Furthermore, in some embodiments, the link mechanism 160 can be fixedly attached or coupled to the support frame 102 and fixedly or slidably attached to the valve anchor 104. When the support frame 102 moves relative to the valve anchor 104, the link mechanism 160 can slide along the U-shaped member 140. In some embodiments, the U-shaped member 140 has a generally arched or convex shape (as illustrated by the U-shaped member in Figure 2) that allows unlimited movement of the link mechanism 160 along the geometric shapes of the first and second legs 146, 148 of the U-shaped member 140. When the link mechanism 160 is able to slide along the first and second legs 146, 148 of the U-shaped member 140, the valve prosthesis 100 may be in a position referred to as a “slidable” state. In the slidable state, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 is variable and may be at its maximum because the link mechanism 160 can move along the first and second legs 146, 148 of the U-shaped member 140.

[0051] In some embodiments, the link mechanism 160 can be fixedly attached to or coupled to the support frame 102 and fixedly attached to the valve anchor 104. As the support frame 102 moves relative to the valve anchor 104, the link mechanism 160 can be elastically and / or plastically stretched, bent, and deformed. As the link mechanism 160 deforms, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 is variable as made possible by the deformation of the link mechanism 160.

[0052] Referring here to Figure 3, according to some embodiments, a side section view of a valve prosthesis 100 loaded on a delivery device 200 is provided. Among the many features illustrated in Figure 3, the delivery device 200 may include a distal carrier assembly 206 that at least partially accommodates a support frame 102. Furthermore, Figure 3 shows that the proximal enclosure 210 of the delivery device 200 may extend over both the valve anchor 104 and the support frame 102. The distal enclosure 212 of the distal carrier assembly 206 may at least partially accommodate the support frame 102. The proximal enclosure 210 may be coupled to a first core member 220, and the distal enclosure 212 may be coupled to a second core member 222. In some embodiments, the distal enclosure 212 may be screw-coupled and / or adhesive-coupled to the second core member 222.

[0053] Therefore, according to some embodiments, in the compression or delivery configuration shown in Figure 3, a link mechanism (not shown) may extend between the valve anchor 104 and the support frame 102 and be at least partially enclosed within the proximal enclosure 210 (depending on the mounting point of the link mechanism with the support frame 102 and the longitudinal extent of the proximal enclosure 210). Further details of the delivery device and prosthesis are provided in U.S. Patents 11,090,156 and 11,083,577, each of which is incorporated herein by reference in whole.

[0054] In addition, Figure 3 illustrates that, in order to facilitate the movement and control of the positioning of the valve anchor 104 during delivery, the delivery system may be used to engage with the engagement area 150 of the valve anchor 104, for example, using a control member or gripper 224. As discussed in U.S. Patents 11,090,156 and 11,083,577, the wholes of each of these are incorporated herein by reference, and this engagement can maintain the engagement area 150 in a common plane oriented substantially perpendicular to the longitudinal axis of the delivery device 200.

[0055] In some embodiments, the delivery device may include a gripping mechanism. The gripping mechanism may have one, two, three, four, or more gripping arms, or other such components that function as contact points with each contact point of the valve prosthesis, such as the valve frame or valve anchor of the prosthesis. Thus, the gripping mechanism can be used to securely bond a portion of the valve anchor to the delivery device, allowing the clinician to control the movement, operation, and deployment of the valve anchor. The gripping mechanism may engage with one or more portions or structures of the valve anchor using a variety of coupling mechanisms, which may include attachment means such as mechanical engagement, dissolvable structures, chemically reactive decomposable structures, electrolytically decomposable structures, and the like.

[0056] In some embodiments, for example, by engaging with the valve anchor at its base portion, the gripper can precisely engage with and control the longitudinal position of the valve anchor. Therefore, the gripper can be used to control the articular movement of the valve anchor as desired by a clinician. For example, each gripper may have independent translational action (e.g., relative to each other) that can collectively "guide" the valve anchor with respect to and away from the central axis or delivery axis of the system, or toward the central axis or delivery axis. Additionally or optionally, the collective and / or individual actions of the grippers can be used to indirectly or directly control or influence the position, shape, and / or movement of the valve frame.

[0057] Figure 4 illustrates an embodiment of the delivery device 200 according to some embodiments. These figures do not illustrate all components of the delivery device that can be incorporated into embodiments. However, the features illustrated in these figures can be incorporated into embodiments of the delivery device to facilitate engagement with the valve anchor and / or to facilitate delivery and control of the valve anchor during implantation and release of the valve anchor at the target site.

[0058] For example, Figure 4 illustrates an embodiment of a delivery device 200 comprising a gripping mechanism 202. The delivery device 200 is shown together with a valve anchor 104 in a partially open but still constrained ("partially deployed") configuration. In some embodiments, the gripping mechanism 202 may comprise at least one gripping arm. In some embodiments, the gripping arm may comprise a tubular enclosure or structure. As shown, the delivery device 200 may have three gripping arms 224a, 224b, and 224c that can engage with and control the longitudinal position of the valve anchor 104.

[0059] In some embodiments, each gripping arm 224a, 224b, 224c of the delivery device 200 may be equipped with an engagement wire that is movable within the lumen of the tubular enclosure. The valve anchor 104 may be configured to be equipped with anchor tabs extending from the engagement areas 150a, 150b, 150c of the valve anchor 104.

[0060] In some embodiments, the engaging wire can interconnect with one or more portions of the valve prosthesis to provide a releasable connection to the valve prosthesis.

[0061] For example, the engagement wire can be removably coupled to a hole, projection, or other structure of the valve anchor. The engagement wire can loop through or around an engagement area, such as the anchor tab of the valve anchor, and be released during clinician action to allow separation of the valve prosthesis from the delivery device.

[0062] In some embodiments, the engagement wire may include a distal end portion comprising a pin, protrusion, or projection that can be coupled to the engagement structure of the anchor tab in the engagement area of ​​the valve anchor. When engaged together, the engagement wire and anchor tab can be retracted proximally into the lumen of the tubular enclosure, thereby fixing the engagement wire and anchor tab to each other in both radial and longitudinal directions. However, when the engagement wire and anchor tab move outside the lumen of the tubular enclosure, the engagement wire and anchor tab disengage as the valve anchor and anchor tab expand radially, thereby disengaging the anchor tab from the engagement wire. Some aspects of the delivery systems, artificial valves, and delivery methods disclosed herein can be implemented in accordance with the features disclosed in the applicant's U.S. Patents 11,090,156 and 11,083,577, each of which is incorporated herein by reference in whole.

[0063] The wire can be constructed from a metallic or non-metallic material. In some embodiments, the valve anchor may include surface-treated (surface-inactivated) nitinol. In such embodiments, it may be advantageous to have the wire from a non-metallic material to avoid surface damage. As discussed herein, the arrangement and positioning of the wire can allow the wire to maintain engagement with the valve anchor rather than requiring or relying on high-friction engagement between the wire and the valve anchor. Therefore, in some embodiments, the wire may include a non-metallic material with a low coefficient of friction with respect to the valve anchor, thus allowing the wire to move smoothly and freely during intentional action by a clinician while avoiding unintended movement.

[0064] Alternatively, the wire can contain a metal such as nitinol, which may be advantageous due to its low tendency to twist and plastic deformation. However, steel or other materials can also be used.

[0065] In some embodiments, the wire may have a diameter of about 0.020 inches for most of its length to provide rigidity, reduce stretching, and provide responsiveness to proximal action during release.

[0066] In some embodiments, the wire can be constructed from a nitinol wire that is centerless ground at the distal end (for example, a 30-50 mm long wire ground from a 0.020 inch diameter wire to a 0.008 inch diameter wire at the distal tip, with the grinding performed on a conical transition). In some embodiments, the ground wire may be connected to an anchor tab.

[0067] The wires include: coreless grinding wire (a continuous piece of material), welding wire (for example, laser welding, which connects two wires of different diameters via welding), a hypotube connected to a small central wire and another wire soldered, brazed, or bonded near the distal end portion of the hypotube (which can offer the advantages of the rigidity of the hypotube and the flexibility of the distal portion using wire), and a wire that is doubled or folded with two offset ends (one end portion extends distally to allow engagement with a valve anchor).

[0068] According to some embodiments, a control member or gripper can be engaged with the valve anchor for a transfemoral retrograde or antegrade delivery approach (as shown in U.S. Patent No. 11,090,156 or U.S. Patent No. 11,083,577) by engaging the delivery device with the prosthetic valve, for example, by using an anchor tab. For example, the anchor tab can receive a control member or gripper approaching the valve anchor proximal to the crest portion to enable the valve anchor to be used in a retrograde (e.g., transfemoral retrograde) approach when delivering the valve anchor. Furthermore, the anchor retaining component can receive a control member or gripper approaching the valve anchor proximal to the first and second U-shaped members, enabling the valve anchor to be used in a antegrade, apical, or transapical approach when delivering the valve anchor.

[0069] Various configurations of the engagement area of ​​the anchor tab of the valve anchor can be used in some embodiments disclosed herein. Furthermore, in any of the embodiments disclosed herein, the engagement area may include a barb or hook through which a link mechanism can pass, as considered in U.S. Patent No. 11,083,577, the whole of which is incorporated herein by reference. The barb or hook may allow unidirectional movement of the link mechanism, and when the link mechanism intersects the barb or hook, the barb or hook prevents reverse movement of the link mechanism over the barb or hook. The illustrated embodiments provide a double crest or cove that may tend to trap the link mechanism during the prosthesis delivery stage, as discussed herein. When the link mechanism is trapped in this manner, the valve prosthesis 100 may be in a position referred to as the “retained” position.

[0070] During use, after the valve anchor is released from the proximal sheath, and after the valve anchor and valve frame are released from the delivery device, the gripping mechanism of the delivery device can be configured to be compactly reassembled and retracted within the introducer sheath to minimize any damage to the vessel through which the delivery device has advanced.

[0071] Referring here to Figures 5A to 7D, a first embodiment of the engagement between the gripping mechanism 300 and the valve anchor 104 is shown in various figures, as well as in the engaged and disengaged positions. Figures 5A and 5B illustrate that the gripping mechanism 300 may comprise a tubular member 302 (a transparent component is shown in Figure 5B) and an engagement wire 304.

[0072] The engaging wire 304 can extend within the lumen 306 of the tubular member 302. The tubular member 302 may have one or more lateral holes or bores 310 through which the engaging wire 304 can pass to form a mutual locking engagement with the valve anchor 104. For example, in some embodiments, the engaging wire can extend within the proximal section of the tubular member and exit the lumen along its distal section to facilitate engagement with the valve anchor.

[0073] As shown in the embodiments of Figures 5A to 7D, the tubular member 302 may have two, three, four, five, or more holes that allow the engaging wire 304 to engage with the valve anchor 104. For example, the engaging wire 304 can exit the lumen 306 and re-enter, facilitating engagement with the anchor tab 152 of the valve anchor 104.

[0074] The anchor tab 152 can enter the lumen 306 of the tubular member 302 through the end opening 312 of the tubular member 302. When positioned inside, the anchor tab 152 can engage with the engagement wire 304. For example, as shown in Figures 5B to 6B, the engagement wire 304 can pass through a slot or hole 170 in the anchor tab 152. In this configuration, the engagement wire 304 can maintain the anchor tab 152 in an engaged position that ensures the gripping mechanism 300 engages firmly with the valve anchor 104. However, during operation by a clinician, the engagement wire 304 can be retracted proximal to the lumen 306 of the tubular member 302. When the engagement wire 304 is retracted proximal to the lumen 304, the end portion 320 of the engagement wire 304 is retracted through the hole 310 of the tubular member 302 until the end portion 320 of the engagement wire 304 is retracted through the slot 170 of the anchor tab 152. This gradual release or disengagement process is illustrated in Figures 7A and 7B. During continuous proximal retraction of the engaging wire 304 through the lumen 306, the engaging wire 304 can be retracted back into the lumen 306 of the tubular member 302, and the anchor tab 152 is disengaged from the engaging wire 304.

[0075] The holes 310 may include one or more proximal holes and / or one or more distal holes. Various embodiments utilizing such holes, which can allow access to the lumen of the tubular member to facilitate engagement with a valve anchor, are illustrated in Figures 5A to 10.

[0076] For example, Figures 5A to 7D illustrate embodiments in which a hole having first and second distal holes 310a, 310b and first and second proximal holes 310c, 310d is arranged, as described in Figure 6B. In some embodiments, the first distal hole 310a can be directly opposite the second distal hole 310b. In some embodiments, the first proximal hole 310c can be directly opposite the second proximal hole 310d. However, the first proximal hole 310c can be longitudinally offset from the second proximal hole 310d.

[0077] To engage with the valve anchor, the engaging wire extends through one or both of the most distal pair of holes 310a, 310b and / or through one or both of the most distal pair of holes 310a, 310b, and can engage with the valve anchor within the engagement area, as discussed herein.

[0078] In some embodiments, the end portion 320 of the engaging wire 304 can be pushed into the first proximal hole 310c, as shown in Figure 6B. This arrangement may help to prevent the end portion 320 from inadvertently extending into another part of the holes 310a, 310b, or 310d (or other).

[0079] However, in some embodiments, it may be advantageous for the final hole (i.e., the hole through which the end portion 320 of the engaging wire 304 enters the lumen 306) to be the second proximal hole 310d. Thus, the arrangement in Figure 6B can be reversed such that the wire 304 first exits the lumen 306 through the first proximal hole 310c, then re-enters the lumen 306 through the second distal hole 310b to engage with the slot 170, then exits the lumen 306 through the first distal hole 310a, and finally re-enters the lumen 306 through the second proximal hole 310d. In such embodiments, the positioning of the wire 304 through these holes can therefore allow for a shorter or faster positional timing release of the end portion 320 of the wire 304 from the second proximal hole 310d.

[0080] According to some embodiments, each hole 310 may have a longitudinal axis extending substantially perpendicular to the longitudinal axis of the tubular member. For example, as shown in Figure 6B, the first and second distal holes 310a and 310b may each have a longitudinal axis extending substantially perpendicular to the longitudinal axis of the tubular member.

[0081] However, alternatively, in some embodiments, the holes 310 may have a longitudinal axis extending laterally with respect to the longitudinal axis of the tubular member, as shown by the first and second proximal holes 310c and 310d in Figure 6B. As shown in Figure 6B, the first and second proximal holes 310c and 310d may each have a longitudinal axis extending laterally with respect to the longitudinal axis of the tubular member. This lateral alignment of the longitudinal axis facilitates the movement of the wire 304 through the hole.

[0082] According to some embodiments, a porous arrangement can allow the wire 304 to be oriented laterally or perpendicularly to the direction of displacement of the tab when it is withdrawn from the lumen 306. The shown embodiments can allow the wire to remain statically positioned and hold or engage with the tab even if the end portion of the wire is inadvertently dislodged from the final hole.

[0083] Subsequently, as shown in Figures 7C and 7D, the valve anchor can begin to detach from the gripping mechanism 300 so that the anchor tab 152 is completely withdrawn from the lumen 306 of the tubular member 302. Once the anchor tab 152 has exited the lumen 306 of the tubular member 302, the valve anchor 104 can freely expand radially relative to the delivery device 200 (not shown).

[0084] Among the many advantages associated with the embodiments illustrated in Figures 5A to 7D, there is secure engagement between the gripping mechanism and the valve anchor 104, while also allowing for easy disengagement. Secure engagement can be achieved according to the novel embodiments disclosed herein, considering the increased ability to have precise tolerances between the fitting length of the anchor tab in the lumen (e.g., the length from the engagement area of ​​the valve anchor to the distal end edge of the slot of the anchor tab) and the length of the hole 324 from its end opening of the tubular member. These tolerances can be matched to provide precise alignment of the slot and hole when the anchor tab is inserted into the lumen and engaged by the engagement wire, minimizing chatter vibration.

[0085] For example, in some embodiments, as illustrated in Figures 6A to 7B, the set of the most distal holes 330 can be positioned at substantially equal longitudinal positions along the axis of the tubular member 302 such that the nearest edge of the slot 170 and the set of the most distal holes 330 are positioned adjacent to each other or at substantially common longitudinal positions along the axis of the tubular member 302. This relative positioning of the nearest edge of the slot 170 and the set of holes 30 at the farthest extent ensures that when the anchor tab 152 is fully inserted into the end opening 312, the positions of these edges can be aligned and engaged with the engaging wire 304, thereby restricting the distal movement of the anchor tab 152 from the lumen 306 of the tubular member 302. Therefore, through the alignment and positioning of the holes 330 and slots 170 of the most distal set of anchor tabs 152, the base portion 144 of the valve anchor 104 can be firmly in contact with and held against the distal end of the tubular member 302 until the engaging wire 304 is drawn proximal to the lumen 306, thereby releasing the valve anchor 104 from engagement with the gripping mechanism 300.

[0086] These and other features disclosed herein provide an innovative design that enables clinicians to enjoy both the benefits of secure engagement of the valve anchor until release of the valve anchor is required, and the certainty that the valve anchor is released without causing damage to any valve anchor or natural valve structure that could inadvertently occur during release (e.g., by requiring torsional, tensile, or bending forces, or other damaging movement).

[0087] Furthermore, according to at least some embodiments disclosed herein, these challenges have remained unresolved despite many companies investing considerable resources in research and development over many years. The applicant has successfully achieved a solution by the embodiments disclosed and suggested herein that enables the precise release of the cardiac valve prosthesis at the target location in order to effectively minimize or prevent accidental release of the valve anchor or cardiac prosthesis during delivery and to avoid any trauma or displacement of the valve prosthesis during delivery.

[0088] Referring now to Figure 8, another embodiment of the gripping mechanism is illustrated. Similar to the embodiments shown in Figures 5A to 7D, the embodiment illustrated in Figure 8 may also comprise a tubular member having a plurality of holes and an engaging wire that passes through the holes and can engage with a portion of the valve anchor.

[0089] As illustrated in Figure 8, the gripping mechanism 400 may comprise a tubular member 402 (shown as a transparent component) and an engaging wire mechanism 404 that can extend at least partially within the lumen 406 of the tubular member 402. The gripping mechanism 400 may share many of the same operating principles and features as the gripping mechanism 300 discussed above, but the engaging wire mechanism 404 provides a simpler alternative structure and function. Therefore, the consideration of the features and advantages of the gripping mechanism 300 can also be applied to the gripping mechanism 400, which will not be repeated herein for the sake of brevity.

[0090] With respect to the engagement wire mechanism 404, some embodiments may provide multiple components, such as a two-part structure that allows independent operation of the components in order to provide additional certainty and separate steps in the release process.

[0091] For example, the engagement wire mechanism 404 may comprise a pull wire 410 and a loop wire 412. The pull wire 410 and the loop wire 412 can intersect and engage with each other at a distal location along the gripping mechanism 400 (for example, adjacent to the docking area along which the valve anchor engages with the gripping mechanism). As illustrated, the pull wire 410 and the loop wire 412 can intersect and create a closed loop, or can engage with the slot 170 of the valve anchor 104 by the engagement wire mechanism 404.

[0092] Therefore, similar to the embodiments discussed above with respect to the gripping mechanism 300, the anchor tab 152 of the valve anchor 104 can be inserted into the end opening 420 of the tubular member 402, and the pull wire 410 and / or loop wire 412 can pass through the slot 170 of the anchor tab 152 to restrict the axial movement of the anchor tab 152 out of the opening 420 until the engaging wire mechanism 404 is disengaged by a clinician, thereby allowing the gripping mechanism 400 to be disengaged from the valve anchor 104.

[0093] According to some embodiments, the loop wire 412 may include engaging structures such as a hole structure 430 that extends through the loop wire 412 or is coupled to the loop wire 412. For example, the loop wire 412 may be configured to incorporate or couple with a hole structure 430 along the distal end portion of the loop wire 412. The hole structure 430 may be configured to receive a pull wire 410 through it, thereby forming a loop that can engage with the slot 170 of the valve anchor 104.

[0094] To disengage the engagement wire mechanism 404 from the slot 170, the clinician can retract the pull wire 410 proximal, ultimately separating the pull wire 410 and withdrawing it from the bore structure 430, thus separating the pull wire 410 from the loop wire 412. Once separated, the loop wire 412 can retract proximal to the lumen 406 and exit the slot 170. During operation, both the pull wire 410 and the loop wire 412 can retract proximal to the lumen 406 after being disengaged from the valve anchor 104, allowing them to be fully positioned within the lumen 406. Furthermore, the anchor tab 152 can exit the end opening 420 to allow the valve anchor 104 to expand freely at the target location.

[0095] According to at least some embodiments disclosed herein, the gripping mechanism 400 can enable a clinician to operate separate control devices or actuators to control the movement of the pull wire 410 and the loop wire 412, thereby establishing a separate step of disengaging the pull wire 410 from the loop wire 412, and then enabling the clinician to finally disengage the loop wire 412 from the slot 170. These actions can be performed via the rotational or translational movement of an actuator or knob on the control handle of the delivery device. This separate step of disengaging the pull wire 410 from the loop wire 412 provides the clinician with additional certainty and control, thereby minimizing or reducing ambiguity regarding when the disengagement process has started or whether the disengagement process has started. This may be advantageous during placement procedures, as it allows the clinician to be given a separate step in the disengagement process.

[0096] In addition, some embodiments of the gripping mechanism 400 can be implemented such that the pull wire 410 has a distal end portion 440 that extends beyond the bore structure 430 to a position adjacent to the end opening 420, or to a position within approximately 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm from the end opening 420. The dimensions and configuration of the distal end portion 440 may depend on the axial length of the slot 170, the position of the portion hole 442 in the tubular member 402, and the gauge of the pull wire 410. In practice, according to some embodiments, the pull wire 410 provides sufficient rigidity to withstand the lateral bending force exerted by the loop wire 412 so that it is pulled through the slot 170 and does not inadvertently detach from the loop wire 412.

[0097] Furthermore, according to some embodiments, the hole structure 430 may have an internal profile or dimensions that closely match the external profile or dimensions of the pull wire 410. According to some embodiments, the external cross-section or profile of the loop wire 412 and the hole structure 430 may be smaller than the corresponding dimensions or profile of the slot 170 in order to allow the loop wire 412 to be pulled through the slot 170.

[0098] For example, according to some embodiments, the hole structure 430 may have an expanded configuration when the pull wire 410 is inserted through it (the expanded configuration may be larger than the corresponding dimensions or profile of the slot 170), thereby preventing the hole structure 430 from passing through the slot 170 in its expanded configuration. However, after the pull wire 410 is removed from the hole structure 430, the hole structure 430 can be compressed into a folded configuration that allows it to pass through the slot 170, or it can automatically return to its original state. Thus, the configuration of the hole structure 430 can facilitate engagement with or disengagement of the anchor tab 152 of the engaging wire mechanism 404.

[0099] Referring here to Figure 9, an additional embodiment of the gripping mechanism 450 is illustrated. The gripping mechanism 450 may comprise a tubular member 452 and an engaging wire 454. Similar to the embodiments discussed above with respect to Figures 5A to 7D, the engaging wire 454 may include a single continuous wire passing through the lumen 456 of the tubular member 452 and through a hole 460 in the tubular member to form a loop that engages with a portion of the valve anchor 104. According to some embodiments, the gripping mechanism 450 may be configured such that the tubular member 452 comprises a slot or cutout 462 along the outer surface of the tubular member 452. The slot or cutout 462 comprises or may comprise a receptacle 464 having one or more structures formed to be complementary to the shape or structure of the valve anchor 104 and / or anchor tab 152.

[0100] For example, the receptacle 464 shown in Figure 9 may include a shoulder area 466 configured to receive a valve anchor 104 and to restrict the longitudinal or axial movement of the valve anchor 104 relative to the tubular member 452. For example, the shoulder area 466 may include a recess or well that allows the valve anchor 104 to be positioned within it and restricts the degree of freedom of movement of the valve anchor 104, except for the degree of radial movement in the translational direction which is generally perpendicular to the longitudinal axis 470 of the tubular member 452. Thus, unless otherwise constrained, the valve anchor 104 can move out of the shoulder area or receptacle 464 in a direction radially away from the longitudinal axis 470, but will be otherwise constrained to movement in other directions (translational or rotational).

[0101] In some embodiments, the engagement wire 454 can restrict the radial movement of the valve anchor 104, thereby providing a secure engagement between the valve anchor 104 and the gripping mechanism 450. For example, the engagement wire 454 can loop around the anchor tab 152 and within the slot 170 of the anchor tab 152, thereby engaging with the anchor tab 152 and the valve anchor 104 to restrict the radial movement of the valve anchor away from the longitudinal axis 470 and away from engagement with the shoulder area 466.

[0102] Optionally, the tubular member 452 may be configured to include opposing rail portions 472 that define a gap between which the receptacle 464 extends longitudinally away from the shoulder area 466 and is configured to receive at least a portion of a valve anchor (e.g., an anchor tab 152). The rail portions 472 can thereby help limit the degree of movement of the anchor tab 152 and the valve anchor 104 relative to the tubular member 452.

[0103] Among the advantages associated with the embodiment of the gripping mechanism 450 illustrated in Figure 9 is the increased ability to disengage and separate the valve anchor 104 from the tubular member 452. For example, the delivery device can be configured such that the receptacle 464 of the gripping mechanism 450 (especially when multiple gripping mechanisms 450 are used, i.e., when three gripping mechanisms are used, such as in the embodiment of the delivery device shown in Figure 4) can face radially outward with respect to the longitudinal axis of the delivery device. Thus, when the receptacle 464 is facing radially outward or open away from the longitudinal axis of the delivery device, the valve anchor 104 can easily expand radially away from the gripping mechanism 450. In this way, when the engagement wire 454 is pulled proximal by the clinician and disengaged from the slot 170, the valve anchor 104 can be immediately released from the tubular member 452 and expand to align with the natural tissue of the target area. Therefore, the gripping mechanism 450 does not tend to interfere with the expansion of the valve anchor 104.

[0104] Referring next to the embodiment illustrated in Figure 10, similar to the embodiment illustrated in Figure 9, the gripping mechanism 480 may comprise a tubular member 482 and an engaging wire 484 that can collectively engage with the valve anchor 104. Similar to the gripping mechanism 450, the gripping mechanism 480 may comprise a receptacle 486 configured to receive at least a portion of the valve anchor 104, such as the anchor tab 152, and to restrict the degree of movement of the valve anchor 104 relative to the tubular member 482. Various features and functions of the tubular member 482 and the receptacle 486 are similar to those discussed above with respect to the tubular member 452 and the receptacle 464 shown in Figure 9, and will be incorporated by reference, though not repeated herein for the sake of brevity.

[0105] In contrast to the embodiment of the gripping mechanism 450 shown in Figure 9, the gripping mechanism 480 may be configured such that the engaging wire 484 includes a distal end segment 488 to which the engaging wire 484 is detachably coupled to an end cap 490 disposed at the distal end of the tubular member 482. The distal end segment 488 of the engaging wire 484 can be attached to the end cap 490. This attachment may be via adhesive or mechanical means. In some embodiments, the end cap 490 can be formed on the distal end segment 488 of the engaging wire 484 before the assembly of the gripping mechanism 480 and the valve anchor 104. Furthermore, the end cap 490 can be separated from and attached to the distal portion 492 of the tubular member 482 such that the end cap 490 remains coupled to the distal portion 492 of the tubular member 482 when the engaging wire 484 is pulled proximal and separated from the end cap 490.

[0106] According to some embodiments, the end cap 490 and distal portion 492 of the tubular member 482 may be separate components that are attached to or joined to each other during the assembly of the delivery device having the component valve prosthesis. However, the end cap 490 and distal portion 492 may have a cavity configured to receive the distal end segment 488 of the engagement wire 484, or form a single feature of the tubular member 482 that forms the cavity. In some embodiments, the distal end segment 488 may be positioned within the cavity 494, with or without adhesive to secure the engagement wire 484 to the inner surface of the cavity 494. Thus, if sufficiently rigid, the engagement wire 484 can function to restrict the radial movement of the valve anchor 104 away from the longitudinal axis of the tubular member 482 (at least in part by the shear strength of the engagement wire 484 adjacent to its insertion into the cavity 494). Furthermore, by means of a peelable adhesive to provide some degree of engagement, by the absence of adhesive (and therefore friction engagement only), or by interference fit (and high friction engagement), the distal end segment 488 of the engaging wire 484 can be fitted and / or positioned within the cavity 494 in a manner that mitigates inadvertent or unintentional separation of the distal end segment 488 from the cavity 494, which can be overcome by intentional proximal forces exerted on the engaging wire 484 during the release of the valve anchor 104. Other advantageous features of the gripping mechanism 480 are similar to those discussed above with respect to the embodiment illustrated in Figure 9 and will not be repeated herein for the sake of brevity.

[0107] Therefore, in the embodiment of the gripping mechanism 480 illustrated in Figure 10, when the engaging wire is pulled proximal and sufficient proximal force is applied, it can be separated from the end cap 490. Subsequently, the engaging wire 484 is pulled proximal into the tubular member 482, thereby enabling the valve anchor 104 to be disengaged and separated from the tubular member 482.

[0108] According to yet another embodiment of the gripping mechanism disclosed herein, Figure 11 illustrates a gripping mechanism 500. The gripping mechanism 500 may comprise a tubular member 502 (shown as a transparent component) having a lateral hole 504 into which the anchor tab 510 of the valve anchor 512 can be inserted and which can engage with the engagement wire 530. The gripping mechanism 500 may offer certain advantages over other embodiments disclosed herein, such as simplicity of design, minimal components, and direct and simplified movement of its components.

[0109] The engagement wire 530 may include a proximal section 532 and a distal section 534. The proximal section may define different dimensions or gauges than the distal section 534. In some embodiments, the proximal section 532 may have a smaller gauge than the distal section 534. As described above, in some embodiments, the wire 530 may be cut, formed from wires and / or hypotubes of different diameters joined together, folded in themselves, or in a combination thereof, to achieve the difference in diameter between the proximal section 532 and the distal section 534. This difference in size or gauge between the proximal section 532 and the distal section 534 may allow for a greater degree of responsiveness (less or no longitudinal stretching) when a clinician retracts the engagement wire 530 proximal or applies force proximal, due to the greater tensile strength of the proximal section 532 compared to the distal section 534. Nevertheless, the distal section 534 can also provide sufficient tensile strength to firmly disengage from the anchor tab 510, as discussed herein.

[0110] According to the embodiment disclosed in Figure 11, the anchor tab 510 can be pre-bent to approximately a right angle during assembly, or folded into the lateral hole 504. Thus, the anchor tab 510 can be identical to the anchor tab 152 illustrated and described in various other embodiments disclosed herein, except that the anchor tab 510 is configured approximately lateral to the longitudinal axis of the anchor tab 510 or the longitudinal axis of the gripping mechanism 500.

[0111] As illustrated in Figure 11, the bending of the anchor tab 510 can form a plug or insertion portion 514 of the anchor tab 510 that can be inserted into the lumen 506 of the tubular member 502 through the lateral hole 504. The anchor tab 510 may include a slot 516 that enters the lumen 506 to a depth sufficient to allow the distal section 534 of the engaging wire 530 to be inserted through the slot 516. In this way, the engaging wire 530 can engage with the anchor tab 510 and restrict the movement of the anchor tab 510 so that it cannot exit the lateral hole 504.

[0112] During operation, the clinician can pull the engaging wire 530 proximal to disengage the distal section 534 of the engaging wire 530 from the slot 516 of the anchor tab 510. Once disengaged, the anchor tab 510 can move freely relative to the tubular member 502, thus allowing for radial expansion of the valve anchor 512. As described above with respect to the gripping mechanism 450 shown in Figure 9, the lateral hole 504 can be opened away from the longitudinal axis of the delivery device so that, when released, the valve anchor 512 can expand freely away from the gripping mechanism 500. Therefore, the gripping mechanism 500 does not tend to interfere with the expansion of the valve anchor 512.

[0113] According to some embodiments, the gripping mechanisms and delivery devices disclosed herein may also be configured such that the anchor tab of the valve anchor includes a notch or projection that can longitudinally overlap or engage with a corresponding projection or notch on the distal end section of the engaging wire. When longitudinally overlapped and constrained within the lumen of the tubular member, the anchor tab and the engaging wire may also be constrained to longitudinal movement relative to each other, thereby securing the anchor tab to the gripping mechanism.

[0114] For example, as shown in Figures 12A to 13, the gripping mechanism 550 may include a tubular member 552 having a lumen 554 in which the engaging wire 556 can be positioned. The engaging wire 556 may include a distal end segment 558, a spherical end portion 560, and a reduced profile section 562.

[0115] The reduced profile section 562 may include a reduced diameter relative to the adjacent proximal section of the engaging wire 556. Furthermore, the spherical end portion 560 may comprise a generally cylindrical component attached to the reduced profile section 562, having a larger diameter than the reduced profile section 562. However, according to some embodiments, the spherical end portion 560 and the reduced profile section 562 may be configured as notches or slots formed in the distal portion of the engaging wire 556, which are configured to be compatible with or engage with the respective projections or components of the anchor tab of the valve anchor.

[0116] In the embodiment illustrated in Figures 12A to 12E, the gripping mechanism 550 can engage with a valve anchor 570 having an anchor tab 572 with a notched portion 574. The notched portion can be configured to receive at least a portion of the spherical end portion 560 of the engaging wire 556. Furthermore, the inner diameter of the lumen 554 can be sized to allow the combined cross-profile or outer profile of the anchor tab 572 and the distal end segment 558 of the engaging wire 556 to fit into the lumen 554 when they overlap longitudinally, as shown in Figure 12A. Furthermore, when they overlap longitudinally, the spherical end portion 560 of the engaging wire 556 is constrained to or within the notched portion 574 of the anchor tab 572, and the reduced profile section 562 generally constrains the enlarged end portion 580 of the anchor tab 572 so that the enlarged end portion 580 and the distal end segment overlap longitudinally. In this way, the anchor tab 572 and the reduced profile section 562 are radially constrained so that the corresponding structures actually engage with each other and firmly hold the anchor tab 572 within the lumen 554 of the tubular member 552.

[0117] Figures 12B to 12E illustrate the stepwise release and disengagement of the anchor tab 572 from within the lumen 554 of the tubular member 552. As shown in Figure 12B, the anchor tab 572 is engaged and fixed within the lumen 554 in a first position where the spherical end portion 560 longitudinally overlaps with the notched portion 574 and the enlarged end portion 580 longitudinally overlaps with the reduced profile section 562. However, as the engaging wire 556 moves distally relative to the tubular member 552 in the direction indicated by arrow 582, the radial constraint on the inner surface of the lumen 554 of the tubular member 552 is removed, as shown in Figure 12C. Once the radial constraint created by the tubular member 552 is removed, the anchor tab 572 and the distal end segment 558 of the engaging wire 556 can be radially separated, as shown in Figure 12D.

[0118] Subsequently, as shown in Figure 12E, the engaging wire 556 can be pulled out proximal to the lumen 554 of the tubular member 552 and inserted into the lumen 554. The valve anchor 570 can then be freely expanded alongside the target site.

[0119] Figure 13 illustrates another embodiment in which the valve anchor 590 comprises an anchor tab 592 having opposing elongated segments 594, 596 that form or define a gap 598 between them. Similar to the embodiments described above with respect to Figures 12A to 12E, the gap 598 may be configured to include corresponding recesses and protrusions that substantially correspond to the shapes of the spherical end portion 560 and the reduced profile section 562 of the engaging wire 556. As described above with respect to Figures 12A to 12E, the considerations are incorporated herein by reference and will not be repeated herein for brevity, but the anchor tab 592 may longitudinally overlap the distal end segment 558 of the engaging wire 556 within the lumen 554 of the tubular member 552. In such a position, the anchor tab 592 is firmly engaged with the engaging wire 556, preventing disengagement from the gripping mechanism 550. Furthermore, as illustrated and discussed in Figures 12B to 12E, the anchor tab 592 can also be pushed out of the lumen 554 and released from engagement with the engagement wire 556.

[0120] Embodiments shown in Figures 12A to 13 illustrate additional features or components of the anchor tab and engaging wire, which allow the simplified structure to utilize interference fits between the engaging wire and anchor tab within the lumen of the tubular member of the gripper mechanism. Furthermore, according to some embodiments, an advantage of some embodiments of the anchor tab and wire arrangement shown in Figure 13 is that each gripper connection can be made individually via temporary engagement by simply pressing the anchor tab against the wire or gripper mechanism until the two notched legs fit over the spherical end portion 560. Once all three connections are made, the handle is actuated to pull all three wires into their respective tubular members, so that the widest portion of the anchor tab 592 can engage the spherical end portion 560 within the gap 598 to effectively lock or seal it. Such arrangements can simplify connections by making temporary connections with each wire and then performing a common locking action during assembly. This can advantageously provide simplified mechanical operation and easier assembly.

[0121] Furthermore, some embodiments may optionally include other interference fit mechanisms that radially engage with the anchor tab of the valve anchor within the lumen of the tubular member. Proximal extensions of such structures, which can be incorporated into the engagement wire or which can perform a function that creates some radial constriction or interference, are shown, for example, in Figures 14 to 15B. These additional embodiments illustrate other components and principles of configuration that can be provided using aspects of some embodiments.

[0122] For example, Figure 14 illustrates an embodiment of a gripping mechanism 600 comprising a tubular member 602 having a lumen 604 and an engaging wire 606 disposed within the lumen 604. The engaging wire 606 may have a zigzag section 608 at its distal end. The zigzag section 608 may have a configuration in which the engaging wire 606 deviates from a generally straight configuration and has one or more bands along the length of the wire 606 in the zigzag section 608.

[0123] For example, the zigzag section 608 may be formed having at least two, at least three, or more bends. As illustrated in Figure 14, the zigzag section 608 may include four bends that cause the engaging wire 606 to deviate from a generally straight shape or configuration. The bends may form first and second bends 610, 612, and the engaging wire 606 may further comprise a distal section 614 that extends distally beyond the second bend 612 within the lumen 604.

[0124] According to some embodiments, the tubular member 602 may have a slot 620 and an end opening 622. When coupled to a valve anchor such as a valve anchor 104, the anchor tab 152 of the valve anchor 104 can be inserted into the end opening 622 of the tubular member and engage with a portion of the engagement wire 606.

[0125] For example, as illustrated, the slot 170 of the anchor tab 152 can receive at least a portion of the second bend 612 and longitudinally overlap with the distal section 614 of the engaging wire 606. In this way, the anchor tab 152 may be at least partially constrained radially and longitudinally due to the projection of the second bend 612 that is radially inserted into and received therein, forming an interference fit between the anchor tab 152 and the distal section 614 of the engaging wire 606 in the lumen 604. Therefore, the size of the lumen 604 may be sufficient to receive both the profile or diameter of the engaging wire 606 and the profile of the anchor tab 152 so that they overlap each other longitudinally, but due to the insertion of the second bend 612 into the slot 170, the anchor tab 152 cannot exit the end opening 622 in the position illustrated in Figure 14.

[0126] Furthermore, since the first bend 610 can be inserted or received through the slot 620 of the tubular member 602, the engaging wire 606 tends to be longitudinally or actually constrained to the tubular member 602.

[0127] However, according to some embodiments, the engaging wire 606 can be retracted proximally using sufficient proximal force, thereby pulling the first bend 610 upward, straightening the first bend 610, and applying a similar tensile / straightening force to the second bend 612. Thus, when the zigzag section 608 is pulled proximally, the first and second bends 610, 612 can be straightened longitudinally, thereby releasing the interference fit between the anchor tab 152 and the second bend 612 of the engaging wire 606 in the lumen 604. Continuing the proximal retraction of the engaging wire, the zigzag section 608 is pulled to a proximal position in the slot 620 in the direction illustrated by arrow 630. As the anchor tab 152 is allowed to exit the end opening 622, the valve anchor 104 and the gripping mechanism 600 are separated and disengaged from each other, thereby allowing the valve anchor 104 to expand alongside the natural valve tissue at the target site.

[0128] Figures 15A and 15B illustrate another embodiment in which a cross-sectional interference fit is used to cause engagement between the anchor tab of the valve anchor and the gripping mechanism, according to one embodiment.

[0129] Referring to Figure 15A, the gripping mechanism 650 may comprise a tubular member 652 having a lumen 654 and an engagement wire 656. The engagement wire 656 may have a tapered shape, such as a wedge shape that tapers distally, so that the engagement wire 656 can overlap longitudinally with the anchor tab 660 of the valve anchor 662. In the first position 670, the reduced profile section 672 of the engagement wire 656 may be biased to engage radially so as to form an interference fit along the proximal portion 674 of the anchor tab 660. The reduced profile section 672 may have a wedge shape or a cone shape, according to some embodiments.

[0130] As those skilled in the art will understand, when the reduced profile section 672 is biased distally to the anchor tab, the cross-sectional profile of the reduced profile section 672 increases until the combined cross-sectional area of ​​the anchor tab 660 and the reduced profile section 672 matches the inner profile of the lumen 654 of the tubular member 652. In this position, the projection 680 of the anchor tab 660 extending through the lateral hole 682 of the tubular member 652 can extend entirely within the lateral hole 682. The presence of the projection 680 and its insertion into the lateral hole 682 tends to prevent the anchor tab 660 from sliding or translating relative to the tubular member 652, thereby constraining its relative longitudinal movement and holding the anchor tab 660 within the lumen 654 of the gripping mechanism 650.

[0131] However, as illustrated in Figure 15B, the engaging wire 656 can be pulled proximal to the lumen 654, thereby allowing the reduced profile section 672 to be pulled proximal to the proximal portion 674 of the anchor tab 660. Once the reduced profile section 672 is pulled proximal to the proximal portion 674 of the anchor tab 660, the proximal portion 674 of the anchor tab 660 can move radially against the side wall or inner surface of the lumen 654, thereby allowing the projection 680 to exit the hole 682. In this manner, after the projection 680 has separated from the hole 682, the anchor tab 660 can be detached from the tubular member 652. Thus, Figure 15B illustrates the separation of the valve anchor 662 from the tubular member 652.

[0132] Therefore, the design and simplifications in Figures 14-15B can provide a reliable and simplified action of the gripping mechanism in some embodiments. The simple proximal retraction of the engaging wire and the subsequent elimination of cross-sectional interference between the anchor tab and the engaging wire can enable the valve anchor to be simply separated and released from the gripping mechanism when operating the deployment device.

[0133] According to yet another embodiment disclosed herein, Figures 16A and 16B illustrate another gripping mechanism according to some embodiment. Figure 16A illustrates a gripping mechanism 700 which may comprise a tubular member 702 having a lumen 704 configured to receive an engagement wire 706, and a distal end section 708 configured to restrict the degree of freedom of movement of a valve anchor 710 when coupled thereto.

[0134] In other embodiments disclosed herein, the lumen 704 of the gripping mechanism 700 can receive a portion of the valve anchor 710, such as the anchor tab 712 of the valve anchor 710. Then, when the anchor tab 712 is in a predetermined position within the lumen 704, the engaging wire 706 can be looped through the proximal and distal holes 720, 722 to engage with the slot or hole 724 of the anchor tab 712, as shown in Figure 16B. The valve anchor 710 is firmly engaged with the gripping mechanism 700, as in other embodiments disclosed herein, which restrict relative axial or longitudinal movement between the anchor tab 712 of the valve anchor 710 and the gripping mechanism 700.

[0135] However, according to some embodiments, the distal end section 708 and / or lumen 704 can be advantageously configured to limit the additional degrees of freedom of movement of the anchor tab 712 when engaged with it. In this way, some embodiments may tend to provide a more rigid interconnection between the gripper devices.

[0136] For example, the lumen 704 can restrict the rotational movement of the anchor tab 712 relative to and within the lumen 704. This can be achieved by forming the anchor tab 712 in a polygonal cross-section such as a rectangle, square, or triangle, or in other shapes having one or more protruding corners, flanges, or tabs that can engage with the corresponding structure or shape of the anchor tab 712 to restrict the rotational movement of the anchor tab 712 relative to the lumen 704. By restricting the rotational movement between them, the valve anchor 710 tends to move integrally with the gripping mechanism 700 of the gripping device, thereby creating more control and precision when positioning the valve anchor 710.

[0137] Accordingly, according to some embodiments, the anchor tab 712 may have a profile or cross-sectional shape configured to fit with a corresponding contour or cross-sectional shape of the lumen 704. The cross-sectional shape of the anchor tab may include a rectangle having chamfered corners 730, the chamfered corners 730 which allow the anchor tab 712 to slide to some extent within the lumen 704, while the flat surface formed by the sides of the rectangle provides rotational constraint.

[0138] As illustrated in general Figure 16A, according to some embodiments, the chamfered corner 730 may include a radius of curvature that is approximately 10% to 50% of the distance between the sides of the rectangular profile of the anchor tab 712, for example, approximately 1 / 7, 1 / 6, 1 / 5, 1 / 4, or 1 / 3 of the distance between the sides of the rectangular profile of the anchor tab 712. Furthermore, the rectangular profile of the anchor tab 712 can define adjacent side length ratios of approximately 2:3, 1:2, 1:3, 1:4, or 1:5.

[0139] In some embodiments, the rectangular profile of the anchor tab 712 can provide a tab width that is at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100 percent larger than the width of the slot 724 extending through the anchor tab 712.

[0140] Optionally, as shown in Figure 17, the distal end section may be formed to include an anchor slot or bay capable of at least partially receiving an anchor in order to provide further rotational constraint between the gripper mechanism and the valve anchor.

[0141] As illustrated, the gripping mechanism 750 may comprise a tubular member 752 including a distal end section 754. The distal end section 754 comprises an anchor slot or bay 756 that provides a gap or space between opposing flanges 758. A valve anchor 760 can be received within the anchor slot 756 and fitted into the gap between the opposing flanges 758. The generally flat profile of the flanges 758 fits with the upper and lower edges of the valve anchor 760 along the width or lateral length of the anchor slot 756, constraining rotational movement between them.

[0142] Therefore, in some embodiments, with the anchor tab (not shown) of the valve anchor 760 received within the lumen of the tubular member 752, the anchor slot 756 can further engage with the base 762 of the anchor tab 760, providing a constraint on relative rotational movement between the anchor 760 and the tubular member 752 around the longitudinal axis of the tubular member 752. Such embodiments can be implemented in combination with or separately from the anchor tab, having a specific cross-sectional profile, to provide rotational constraint and engagement with the lumen of the tubular member, as discussed above with respect to Figures 16A and 16B.

[0143] Figures 16A to 17 show that in some embodiments, a tubular member may include a rounded (e.g., circular) outer profile along its entire length or at least a portion of its length. Furthermore, some embodiments may have a non-circular outer profile along its entire length or at least a portion of its length.

[0144] In addition, various embodiments throughout this disclosure illustrate that the lumen of a tubular member may have a substantially circular (e.g., circular) cross-sectional inner profile or lumen profile. Figures 16A and 16B illustrate that a tubular member may include a non-circular (e.g., non-circular) lumen profile along at least a portion of its length. As described above, the lumen may include a polygonal cross-section such as a rectangle, square, or triangle, or other shapes having one or more protruding corners, flanges, or tabs that can engage with the corresponding structure or shape of the anchor tab. Such a non-circular lumen profile may be formed along the entire length of the tubular member or at least a portion of its length.

[0145] The shape of at least a portion of the outer profile or lumen profile can be formed or modified, as desired, by an extrusion process or by post-extrusion heating and deformation, using an end-part forming tool against which a tubular member is pressed to modify the outer profile and / or lumen profile.

[0146] Furthermore, in some embodiments, the rounded or non-rounded outer profile may extend along all or part of the length of the tubular member, and the rounded or non-rounded lumen profile may extend along all or part of the length of the tubular member. Thus, the tubular member may have a rounded outer profile that transitions into a non-rounded outer profile, and a non-rounded lumen profile.

[0147] Therefore, according to some embodiments, a clinician can operate a valve anchor by engaging or coupling a gripper with the anchor tab of the valve anchor. The gripper and anchor tab can restrict relative longitudinal, rotational, and / or radial movement by aligning and enclosing or interconnecting the gripper and anchor tab with each other, such as within or relative to a tubular enclosure. To disengage the gripper and anchor tab, the clinician can pull out or advance an engagement wire disposed within the gripper. This relative movement can cause or enable a slip or separation between the gripper and the anchor tab. Once separated, the valve anchor tends to expand radially outward, thereby disengaging the anchor tab from the gripper. The gripper can then be retracted or pulled out into the tubular enclosure.

[0148] An example of subject matter technology as a clause Various embodiments of the aspects of this disclosure are described for convenience as sets of clauses having numbered clauses (1, 2, 3, etc.). These are provided as embodiments and do not limit the art of the subject matter. The identification of figures and reference numbers is provided below solely as embodiments and for illustrative purposes, and these identifications do not limit the clauses.

[0149] Clause 1. An artificial heart valve delivery device comprising: a docking area defining a longitudinal axis; and an engagement wire extending along the longitudinal axis, wherein the engagement wire comprises: a first section; a second section; and a loop-shaped section interposed between the first section of the second section along the engagement wire, the engagement wire having: (i) an engagement position in which the loop-shaped section extends through the docking area and the second section at least partially overlaps the first section longitudinally to facilitate engagement between the delivery device and a heart valve prosthesis in the docking area; and (ii) a disengagement position in which the second section is positioned distal to the loop-shaped section and the first section to allow disengagement of the heart valve prosthesis from the docking area.

[0150] Clause 2. The delivery device of Clause 1, further comprising a tubular member having a lumen that at least partially defines a docking area.

[0151] Clause 3. The delivery device of Clause 2, wherein the engaging wire extends through the lumen.

[0152] Clause 4. A delivery device according to Clause 2 or 3, wherein the docking area is configured to receive a projection or tab of a heart valve prosthesis inside.

[0153] Clause 5. A delivery device according to any one of Clauses 2 to 4, wherein the tubular member comprises at least one hole extending through the side wall of the tubular member into the lumen of the tubular member, and in the engagement position, an engagement wire is positioned within the lumen and extending through the hole.

[0154] Clause 6. A delivery device according to any one of Clauses 2 to 5, wherein the tubular member comprises a distal set of holes extending through the side walls of the tubular member toward the lumen of the tubular member, and an engaging wire extending through the distal set of holes to facilitate engagement between the delivery device and the heart valve prosthesis in the docking area.

[0155] Clause 7. A delivery device according to any one of the preceding clauses, further comprising a tubular member having a lumen that at least partially defines a docking area, wherein the tubular member has four holes extending from the outer surface of the tubular member to the lumen, and an engaging wire is disposed through the first and second holes such that a second section of the engaging wire is disposed outside the lumen, the engaging wire is disposed through the second and third holes such that a second segment of the engaging wire extends through the docking area within the lumen, the engaging wire is disposed through the third and fourth holes such that a third segment of the engaging wire is disposed outside the lumen, and the engaging wire is disposed through the fourth hole such that a fourth segment of the engaging wire is disposed outside the lumen.

[0156] Clause 8. A delivery device according to any one of the preceding clauses, further comprising a tubular member having a lumen that at least partially defines a docking area, wherein the tubular member has four holes extending from the outer surface of the tubular member to the lumen, and the proximal and distal segments of an engaging wire are disposed within the lumen, the engaging wire passing through the four holes to form a loop segment extending through the docking area within the lumen.

[0157] Clause 9. A delivery device according to any one of the preceding clauses, further comprising a tubular member having a lumen that at least partially defines a docking area, wherein the tubular member comprises first, second, third, and fourth holes extending from the outer surface of the tubular member to the lumen, the first and fourth holes each having a longitudinal axis extending laterally with respect to the longitudinal axis of the tubular member, and the second and third holes each having a longitudinal axis extending substantially perpendicular to the longitudinal axis of the tubular member.

[0158] Clause 10. The delivery device according to Clause 9, wherein the second and third holes are arranged at substantially equal longitudinal positions along the longitudinal axis of the tubular member.

[0159] Clause 11. A delivery device according to Clause 9 or 10, wherein the first hole is interposed between the fourth hole and the second and third holes along the longitudinal axis of the tubular member.

[0160] Clause 12. A delivery device according to any one of Clauses 9 to 11, wherein the first hole is longitudinally offset from the second, third, and fourth holes along the longitudinal axis of the tubular member.

[0161] Clause 13. A delivery device according to any one of the preceding clauses, further comprising a tubular member having a lumen that at least partially defines a docking area, wherein the tubular member has a plurality of holes extending from the outer surface of the tubular member to the lumen, and an engaging wire extending through the lumen and the plurality of holes.

[0162] Clause 14. The delivery device of Clause 13, further comprising at least one hole which is longitudinally offset from another hole along the longitudinal axis of the tubular member.

[0163] Clause 15. A delivery device according to any one of the preceding clauses, further comprising a tubular member, the tubular member having a lumen that at least partially defines a docking area, an open end that allows access to the docking area, and a plurality of holes extending from the outer surface of the tubular member into the lumen that allow an engagement wire to extend out of and into the lumen, across the docking area, and engage with a portion of a heart valve prosthesis that extends into the open end of the tubular member.

[0164] Clause 16. A delivery device according to any one of the preceding clauses, further comprising three tubular members, the three tubular members forming their respective docking areas for engaging with a valve.

[0165] The delivery device of Clause 17. The delivery device of Clause 16, further comprising a proximal sheath from which three tubular members extend, wherein the proximal sheath is retractable to allow expansion of the heart valve prosthesis and the three tubular members before disengaging the delivery device from the heart valve prosthesis.

[0166] Clause 18. A delivery device according to any one of the preceding clauses, comprising an enclosure having an opening for receiving a portion of a heart valve prosthesis and enabling coupling between the heart valve prosthesis and the delivery device.

[0167] Clause 19. A delivery device according to any one of the preceding clauses, further comprising a tubular member, the tubular member having a lumen and a pair of most distal holes extending from the outer surface of the tubular member into the lumen, wherein the pair of most distal holes are opposite each other and positioned at a first longitudinal position along the longitudinal axis of the tubular member, and an engagement wire extending across a docking area into the lumen through the pair of most distal holes to enable engagement with a heart valve prosthesis.

[0168] Clause 20. A delivery device according to Clause 19, wherein a first longitudinal position is set at a first distance from the end of a tubular member, and the heart valve prosthesis comprises an elongated tab, the elongated tab having a base and a hole extending through the elongated tab, and the first distance is substantially equal to the distance from the edge of the hole to the base, in order to enable a tight fit between the elongated tab and the tubular member at the engagement position and to minimize relative movement.

[0169] Clause 21. An artificial heart valve delivery device for delivering a heart valve prosthesis, the device comprising: a core member defining a longitudinal axis; a proximal sheath extending over the core member; and a plurality of gripping mechanisms extending along the longitudinal axis within the proximal sheath for engaging with a heart valve prosthesis, each gripping mechanism comprising: a longitudinal axis; an elongated docking area extending along the longitudinal axis; and an engagement wire extending along the gripping mechanism, the engagement wire comprising a proximal section and a loop-shaped section, the loop-shaped section extending perpendicularly to the longitudinal axis through the docking area to facilitate engagement between the gripping mechanism and the heart valve prosthesis in an engagement configuration; and the engagement wire being retractable proximal to pull the loop-shaped section out from the docking area to disengage the gripping mechanism from the heart valve prosthesis in an disengagement configuration.

[0170] Clause 22. A delivery device according to Clause 21, comprising multiple gripping mechanisms, including three gripping mechanisms.

[0171] Clause 23. A delivery device according to Clause 21 or 22, wherein each gripping mechanism comprises a tubular member on which a docking area is provided.

[0172] Clause 24. A delivery device according to Clause 23, wherein the tubular member comprises a plurality of holes extending through the side walls of the tubular member into the lumen of the tubular member, the plurality of holes being configured to allow the passage of an engaging wire passing through them.

[0173] Clause 25. A delivery device according to Clause 24, wherein the plurality of holes include a pair of opposing holes positioned in substantially the same axial position with respect to the longitudinal axis of a tubular member, and the opposing holes are substantially opposite each other.

[0174] Clause 26. The delivery device of Clause 25, wherein the engaging wire passes through opposing holes so as to cross the docking area in the engaging configuration.

[0175] Clause 27. A delivery device according to Clause 25 or 26, wherein the plurality of holes further include at least one proximal hole in the tubular member proximal to a pair of opposing holes, the at least one proximal hole being configured to allow an engaging wire to extend from the lumen along the tubular member to a location outside the lumen.

[0176] Clause 28. A delivery device according to any one of Clauses 24-27, having multiple holes, including four holes.

[0177] Clause 29. A delivery device according to any one of Clauses 24-28, having multiple holes, including five holes.

[0178] Clause 30. A delivery device according to Clause 23, wherein the tubular member comprises an elongated receptacle disposed along the side wall of the tubular member.

[0179] Clause 31. A delivery device according to Clause 30, wherein the receptacle extends at least partially within the side wall, and the receptacle has an axial length greater than its width.

[0180] Clause 32. A delivery device according to Clause 30 or 31, wherein the receptacle comprises a shoulder area defined by a recess along the length of the receptacle, which is configured to receive a portion of a heart valve prosthesis, and the shoulder area restricts the freedom of movement of at least one portion of the heart valve prosthesis.

[0181] Clause 33. A delivery device according to Clause 32, wherein the receptacle comprises a pair of opposing rail portions that extend at least partially along the length of the receptacle, the opposing rail portions being configured to laterally restrict the movement of at least a portion of the heart valve prosthesis.

[0182] Clause 34. A delivery device according to Clause 33, wherein in an engagement configuration, a loop-shaped section of the engagement wire extends from the lumen of a tubular member through the receptacle to the outside of the lumen in order to engage with a heart valve prosthesis.

[0183] Clause 35. A delivery device according to Clause 34, wherein the tubular member comprises a pair of opposing holes extending from the lumen of the tubular member through the side walls of the tubular member, the pair of opposing holes facing each other substantially opposite to each other around the tubular member, and a loop-shaped section of an engaging wire extending through a receptacle, through the pair of opposing holes, through the lumen, to the opposing outer surfaces of the tubular member.

[0184] Clause 36. A delivery device according to Clause 35, wherein a tubular member comprises a proximal bore extending through the side wall of the tubular member, and in an engagement configuration, an engagement wire extends sequentially through the proximal bore to the outside of the lumen, through another proximal bore to the inside of the lumen, through the receptacle and docking area to a location outside the lumen, through a pair of opposing bores to the outside of the lumen, and into yet another proximal bore within the lumen.

[0185] Clause 37. A delivery device according to any one of Clauses 34 to 36, wherein the tubular member comprises an end cover member disposed at the distal end of the tubular member, the end cover member being configured to be coupled to the distal end of an engagement wire to secure an engagement wire extending from the lumen over the receptacle in order to facilitate engagement with a cardiac valve prosthesis in an engagement configuration.

[0186] Clause 38. A delivery device according to Clause 37, wherein an end cover member is releasably coupled to the end cover member.

[0187] Clause 39. A delivery device according to Clause 38, wherein the end cover member is bonded to the end cover member by adhesive or mechanical means.

[0188] Clause 40. A delivery device according to any one of Clauses 21 to 39, wherein the engaging wire comprises a pull wire and a loop wire, the loop wire having a hole structure into which the pull wire can extend in the engaging configuration, the pull wire being retractable proximal to disengage from the hole structure to allow separation of the pull wire from the loop wire, and the pull wire and loop wire being retractable proximal to a docking area to allow disengagement of the gripper mechanism from the heart valve prosthesis.

[0189] Clause 41. A delivery device according to Clause 40, wherein each gripping mechanism comprises a tubular member having a docking area, the tubular member having a lumen configured to receive the pull wire and the loop wire when the pull wire and loop wire are proximal to the retraction of the pull wire and loop wire.

[0190] Clause 42. A delivery device according to Clause 41, wherein the tubular member comprises a pair of opposing holes extending from the lumen of the tubular member through the side walls of the tubular member, the pair of opposing holes facing each other substantially opposite to each other around the tubular member, and a loop wire extending through the pair of opposing holes through a docking area, the loop wire being engaged by a pull wire within the lumen of the tubular member.

[0191] Clause 43. An artificial heart valve delivery device for delivering a heart valve prosthesis, the device comprising: a gripping mechanism having a longitudinal axis; a tubular member having a lumen; a docking hole extending into the lumen through the side wall of the tubular member; and an engagement wire extending through the lumen toward the docking hole, wherein the engagement wire is configured to pass through and engage with a slot or hole in the clasper tongue of a heart valve prosthesis, the engagement wire extending substantially parallel to the longitudinal axis, and the clasper tongue extending substantially laterally with respect to the longitudinal axis, thereby facilitating engagement between the gripping mechanism and the heart valve prosthesis in an engagement configuration, and the engagement wire being retractable proximal to the slot or hole in the clasper tongue to disengage the gripping mechanism from the heart valve prosthesis in a disengagement configuration.

[0192] Clause 44. The delivery device of Clause 43, wherein the engaging wire includes a straight wire.

[0193] Clause 45. A delivery device according to Clause 43 or 44, wherein the docking hole extends laterally with respect to the longitudinal axis along the side wall of the tubular member.

[0194] Clause 46. A delivery device according to any one of Clauses 43 to 45, wherein the device comprises multiple gripping mechanisms, and the docking holes of each gripping mechanism face away from the other gripping mechanisms.

[0195] Clause 47. An artificial heart valve delivery device comprising: a gripping mechanism having a longitudinal axis; a tubular member having a lumen and an open end; and an engagement wire extending through the lumen toward the open end, wherein the engagement wire has a distal end segment having projections or recesses configured to abut against the respective recesses or projections of the clasper tongue of a heart valve prosthesis to form a component connection, wherein in the engagement configuration, the distal end segment and the clasper tongue overlap longitudinally within the lumen, and collectively define a cross-sectional shape smaller than the inner diameter of the lumen so as to radially restrain the movement of the distal end segment and the clasper tongue by the lumen and restrict the movement of the distal end segment relative to the clasper tongue, wherein the distal end segment of the engagement wire moves distally from the lumen so as to radially displace the distal end segment and the clasper tongue toward each other and disengage, and the clasper tongue can move freely away from the engagement wire to disengage the heart valve prosthesis from the gripping mechanism.

[0196] Clause 48. A delivery device according to Clause 47, wherein the distal end segment of the engaging wire comprises an elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[0197] Clause 49. A delivery device according to Clause 47 or 48, wherein the distal end segment of the engaging wire comprises a pair of elongated prongs, each elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[0198] Clause 50. A delivery device according to Clause 49, wherein each elongated prong is provided with a lateral bump, each lateral bump extending radially from the surface of the elongated prong in a direction away from both elongated prongs, and the lateral bump is configured to contact the inner surface of the lumen in order to maintain engagement between the distal end segment of the heart valve prosthesis and the clasp parting.

[0199] Clause 51. A delivery device according to any one of Clauses 47-50, comprising a distal end segment comprising double opposing hooks configured to engage with the clasp pattern of a cardiac valve prosthesis.

[0200] Clause 52. An artificial heart valve system comprising a delivery device according to any one of Clauses 47 to 50 and a heart valve prosthesis including a clasp partang, wherein the clasp partang has an elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[0201] Clause 53. An artificial heart valve system comprising a delivery device according to any one of Clauses 47 to 50 and a heart valve prosthesis including a clasp-parting tongue, wherein the clasp-parting tongue has a pair of elongated prongs, each elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[0202] Clause 54. The system of Clause 53, wherein each elongated prong is provided with a lateral bump, each lateral bump extending radially from the surface of the elongated prong toward both elongated prongs, and the lateral bump is configured to contact the inner surface of the lumen in order to maintain engagement between the distal end segment of the heart valve prosthesis and the clasp parting.

[0203] Clause 55. The system of Clause 53 or 54, wherein the clasp pattern comprises a double opposing hook configured to engage with the distal end segment of the engaging wire in an engaging configuration.

[0204] Clause 56. An artificial heart valve delivery device comprising a gripping mechanism, the gripping mechanism comprising: a tubular member having a lumen, a lateral hole extending from the lumen to the outer surface of the tubular member, and an open end; and an engaging wire extending through the lumen toward the open end, the engaging wire having a distal end segment configured to overlap at least partially longitudinally with the clasp parting of a heart valve prosthesis positioned within the lumen, wherein (i) in the engaged position, the distal end segment overlaps longitudinally with the clasp parting in the lumen and tightens within the lumen A delivery device comprising: (ii) a first position in which an engagement structure coupled to an engagement wire or clasp parting protrudes into a lateral hole of a tubular member, thereby restricting the longitudinal movement of the clasp parting relative to the tubular member; and (ii) a disengagement position in which the distal end segment is positioned at a second position proximal to the first position, and the distal end segment and clasp parting release the interference fit, allowing the engagement structure to be withdrawn from the lateral hole, thereby enabling the longitudinal movement of the clasp parting relative to the tubular member.

[0205] Clause 57. A delivery device according to Clause 56, wherein the distal end segment of the engaging wire includes a zigzag section having first and second bends, wherein in the engaging position, the first bend is configured to be received in a lateral hole of a tubular member, and the second bend is configured to engage with a hole in a clasp pattern.

[0206] Clause 58. A delivery device according to Clause 57, wherein the distal end segment is located distal to the first and second bends and includes a straight, most distal section configured to longitudinally overlap with the clasp parting in the lumen at the engagement position, thereby assisting in creating an interference fit.

[0207] Clause 59. A delivery device according to any one of Clauses 56 to 58, wherein the distal end segment of the engaging wire has a tapered cross-sectional profile that decreases distally.

[0208] Clause 60. A delivery device according to Clause 59, wherein the distal end segment comprises a wedge section that decreases distally.

[0209] Clause 61. A delivery device according to Clause 59 or 60, wherein the distal end segment comprises a flat surface configured to abut against a clasp pattern.

[0210] A delivery system comprising a delivery device according to Clause 62.56 and a heart valve prosthesis having a clasp parting, wherein the clasp parting comprises an elongated body having a projection extending laterally with respect to the longitudinal access of the elongated body, the projection projecting into a lateral hole of a tubular member, and configured to restrict the longitudinal movement of the clasp parting relative to the tubular member when the clasp parting is in an engagement position with the engagement wire of the delivery device.

[0211] Clause 63. An artificial heart valve delivery device comprising any of the features enumerated in any one of the preceding clauses.

[0212] Clause 64. An artificial heart valve system comprising a heart valve prosthesis and an artificial heart valve delivery device having any of the features listed in Clauses 1 to 62.

[0213] Clause 65. A method for assembling an artificial heart valve delivery device as enumerated in any of the preceding clauses.

[0214] Clause 66. A method for delivering an artificial heart valve delivery device as enumerated in any one of the preceding clauses, comprising advancing the heart valve prosthesis to a target location within a human heart and releasing the heart valve prosthesis from the delivery device.

[0215] Clause 67. Devices, systems, and methods listed in any one of the above clauses, wherein the anchor tab comprises a cross-sectional projection or profile configured to engage with a corresponding cross-sectional recess or profile of a tubular member in order to restrict relative rotation between the anchor tab and the tubular member when the anchor tab is received in the lumen.

[0216] Clause 68. Devices, systems, and methods listed in any one of the above clauses, wherein the distal end portion of a tubular member comprises an anchor slot configured to receive a portion of a valve anchor in order to restrict relative rotation between the valve anchor and the distal end portion about the longitudinal axis of the tubular member.

[0217] Further considerations In some embodiments, any of the provisions of this specification may be dependent on any one of the independent provisions or any one of the dependent provisions. In some embodiments, any of the provisions (e.g., dependent or independent provisions) may be combined with any one or more other provisions (e.g., dependent or independent provisions). In some embodiments, a claim may include some or all of the words (e.g., steps, actions, means, or components) listed in a provision, sentence, phrase, or paragraph. In some embodiments, a claim may include some or all of the words listed in one or more provisions, sentences, phrases, or paragraphs. In some embodiments, some of the words in each of the provisions, sentences, phrases, or paragraphs may be removed. In some embodiments, additional words or elements may be added to a provision, sentence, phrase, or paragraph. In some embodiments, the subject art may be implemented without utilizing any of the components, elements, functions, or actions described herein. In some embodiments, the subject art may be implemented using additional components, elements, functions, or actions.

[0218] The foregoing description is provided to enable those skilled in the art to implement the various configurations described herein. While the subject art has been described in particular with reference to various figures and configurations, it should be understood that these are for illustrative purposes only and should not be construed as limiting the scope of the subject art.

[0219] Many other methods may exist for implementing the subject art. Various functions and elements described herein may be divided in ways different from those shown, without departing from the scope of the subject art. Various modifications to these configurations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other configurations. Therefore, many changes and modifications to the subject art may be made by those skilled in the art without departing from the scope of the subject art.

[0220] It is understood that the specific order or hierarchy of steps within the disclosed process is illustrative of an exemplary approach. It is understood that the specific order or hierarchy of steps within the process may be rearranged based on design preferences. Some steps may be performed simultaneously. The claims of the appended method illustrate elements of various steps in an exemplary order and are not intended to limit the present order or hierarchy.

[0221] As used herein, the term “distal” may refer to a location or direction away from a point of interest, such as the user, control unit, or delivery system area, used to deliver the valve prosthesis to the natural valve annulus. In addition, the term “proximal” may refer to a location or direction close to a point of interest, such as the user, control unit, or delivery system area, used to deliver the valve prosthesis.

[0222] Where used herein, the phrase “at least one” preceding a set of items modifies the list as a whole, rather than each member of the list (i.e., each item), by using the terms “and” or “or” to separate any of the items. The phrase “at least one” does not require the selection of at least one of each enumerated item; rather, the phrase allows for the meaning of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. In practice, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” refer, respectively, to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0223] Terms such as “top,” “bottom,” “front,” and “rear” as used in this disclosure should be understood to refer to an arbitrary reference frame, not a typical gravity reference frame. Therefore, the top, bottom, front, and rear surfaces may extend upward, downward, diagonally, or horizontally within the gravity reference frame.

[0224] Furthermore, where the terms “include,” “have,” or similar are used in this specification or in the claims, such terms are intended to be inclusive in a similar manner to the term “comprise,” so that they may be interpreted as “comprise” when adopted as transitional terms in the claims.

[0225] The term “exemplary” is used herein to mean “functioning as an example, case, or illustration.” Any embodiment described herein as “exemplary” is not necessarily construed to be preferable or advantageous to other embodiments.

[0226] References to singular elements, unless specifically stated, are intended to mean "one or more" rather than "one and only one." Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. The term "some" refers to one or more. Underlined and / or italicized headings and subheadings are used for convenience only and are not intended to limit the subject art, nor are they referenced in connection with the interpretation of the description of the subject art. All structural and functional equivalents to elements of the various configurations described through this disclosure that are known to those skilled in the art, or will become known thereafter, are expressly incorporated herein by reference and are intended to be included in the subject art. Furthermore, no disclosure disclosed herein, whether or not such disclosure is expressly enumerated in the above description, is intended to be made public.

[0227] While the detailed descriptions include many specific details, these should not be interpreted as limiting the scope of the subject art, but merely as illustrating different embodiments and aspects of the subject art. Naturally, the scope of the subject art includes other embodiments not discussed in detail above. Various other modifications, changes, and variations can be made to the arrangement, operation, and details of the methods and apparatus of the subject art disclosed herein without departing from the scope of this disclosure. Unless otherwise expressed, references to singular elements mean "one or more" rather than "one and only one" unless expressly stated. In addition, for a device or method to be included within the scope of this disclosure, it is not necessary to address (or have achieved) every problem that can be solved by a different embodiment of this disclosure. The use of "can" and its derivatives herein should be understood as "possibly" or "optionally," as opposed to a positive ability.

Claims

1. An artificial heart valve delivery device, A docking area that defines the longitudinal axis, An engaging wire extending along the longitudinal axis, Equipped with, The engaging wire comprises a first section, a second section, and a loop-shaped section interposed between the first section and the second section along the engaging wire. A delivery device having (i) an engagement position in which the loop-shaped section extends through the docking area and the second section at least partially overlaps the first section longitudinally to facilitate engagement between the delivery device and the heart valve prosthesis in the docking area, and (ii) a disengagement position in which the second section is positioned distal to the loop-shaped section and the first section to allow disengagement of the heart valve prosthesis from the docking area.

2. The delivery device according to claim 1, further comprising a tubular member having a lumen that at least partially defines the docking area.

3. The delivery device according to claim 2, wherein the engaging wire extends through the lumen.

4. The delivery device according to claim 2 or 3, wherein the docking area is configured to receive a projection or tab of the heart valve prosthesis.

5. The delivery device according to any one of claims 2 to 4, wherein the tubular member comprises at least one hole extending through the side wall of the tubular member to the lumen of the tubular member, and in the engagement position, the engagement wire is positioned within the lumen and extends through the hole.

6. The delivery device according to any one of claims 2 to 5, wherein the tubular member comprises a distal set of holes extending through the side wall of the tubular member toward the lumen of the tubular member, and the engaging wire extends through the distal set of holes to facilitate engagement between the delivery device and the heart valve prosthesis in the docking area.

7. The docking area is further comprising a tubular member having a lumen that at least partially defines the docking area, wherein the tubular member has four holes extending from the outer surface of the tubular member to the lumen, The engaging wire is disposed through a first hole and a second hole such that the first segment of the engaging wire is disposed on the outside of the lumen. The engaging wire is disposed through the second and third holes such that the second segment of the engaging wire extends through the docking area within the lumen. The engaging wire is disposed through the third and fourth holes such that the third segment of the engaging wire is disposed on the outside of the lumen. The delivery device according to claim 1, wherein the engaging wire is disposed through the fourth hole such that the fourth segment of the engaging wire is disposed within the lumen.

8. The delivery device according to any one of claims 1 to 7, further comprising a tubular member having a lumen that at least partially defines the docking area, wherein the tubular member has four holes extending from the outer surface of the tubular member to the lumen, the proximal and distal segments of the engagement wire are disposed within the lumen, and the engagement wire passes through the four holes to form a loop segment extending through the docking area within the lumen.

9. The delivery device according to any one of claims 1 to 8, further comprising a tubular member having a lumen that at least partially defines the docking area, wherein the tubular member comprises first, second, third, and fourth holes extending from the outer surface of the tubular member to the lumen, the first and fourth holes each having a longitudinal axis extending laterally with respect to the longitudinal axis of the tubular member, and the second and third holes each having a longitudinal axis extending substantially perpendicular to the longitudinal axis of the tubular member.

10. The delivery device according to claim 9, wherein the second and third holes are arranged at substantially equal longitudinal positions along the longitudinal axis of the tubular member.

11. The delivery device according to claim 9 or 10, wherein the first hole is interposed between the fourth hole and the second and third holes along the longitudinal axis of the tubular member.

12. The delivery device according to any one of claims 9 to 11, wherein the first hole is longitudinally offset from the second, third, and fourth holes along the longitudinal axis of the tubular member.

13. The delivery device according to any one of claims 1 to 13, further comprising a tubular member having a lumen that at least partially defines the docking area, wherein the tubular member has a plurality of holes extending from the outer surface of the tubular member to the lumen, and the engaging wire extends through the lumen and the plurality of holes.

14. Furthermore, the delivery device according to claim 13, wherein at least one hole is longitudinally offset from another hole along the longitudinal axis of the tubular member.

15. A delivery device according to any one of claims 1 to 14, further comprising a tubular member, the tubular member having a lumen that at least partially defines the docking area, an open end that allows access to the docking area, and a plurality of holes extending from the outer surface of the tubular member to the lumen, for enabling the engagement wire to extend out of and into the lumen, across the docking area, and engage with a portion of the heart valve prosthesis that extends into the open end of the tubular member.

16. The delivery device according to any one of claims 1 to 15, further comprising three tubular members, the three tubular members each forming a docking area for engaging with the valve.

17. The delivery device according to claim 16, further comprising a proximal sheath on which the three tubular members extend, wherein the proximal sheath is retractable to allow expansion of the heart valve prosthesis and the three tubular members before disengaging the delivery device from the heart valve prosthesis.

18. The delivery device according to any one of claims 1 to 17, wherein the docking area comprises an enclosure having an opening for receiving a portion of the heart valve prosthesis and enabling coupling between the heart valve prosthesis and the delivery device.

19. A delivery device according to any one of claims 1 to 18, further comprising a tubular member, the tubular member having a lumen and a pair of most distal holes extending from the outer surface of the tubular member into the lumen, wherein the pair of most distal holes are opposite each other and positioned at a first longitudinal position along the longitudinal axis of the tubular member, and the engaging wire extends through the pair of most distal holes into the lumen across the docking area to enable engagement with the heart valve prosthesis.

20. The delivery device according to claim 19, wherein the first longitudinal position is set at a first distance from the end of the tubular member, the heart valve prosthesis comprises an elongated tab, the elongated tab having a base and a hole extending through the elongated tab, and the first distance is substantially equal to the distance from the edge of the hole to the base in order to enable a tight fit between the elongated tab and the tubular member at the engagement position and to minimize relative movement.

21. An artificial heart valve delivery device for delivering a heart valve prosthesis, wherein the device is A core member defining the longitudinal axis, A proximal sheath extending over the core member, A delivery device comprising: a plurality of gripping mechanisms extending along the longitudinal axis within the proximal sheath for engaging with the heart valve prosthesis, each gripping mechanism comprising: a longitudinal axis; an elongated docking area extending along the longitudinal axis; and an engagement wire extending along the gripping mechanism, wherein the engagement wire comprises a proximal section and a loop-shaped section, the loop-shaped section extending perpendicularly to the longitudinal axis through the docking area to facilitate engagement between the gripping mechanism and the heart valve prosthesis in an engaged configuration, and the engagement wire being retractable proximal to pull the loop-shaped section proximal out of the docking area to disengage the gripping mechanism from the heart valve prosthesis in an disengaged configuration.

22. The delivery device according to claim 21, wherein the plurality of gripping mechanisms includes three gripping mechanisms.

23. The delivery device according to claim 21 or 22, wherein each gripping mechanism comprises a tubular member on which the docking area is provided.

24. The delivery device according to claim 23, wherein the tubular member has a plurality of holes extending through the side wall of the tubular member to the lumen of the tubular member, and the plurality of holes are configured to allow the passage of the engaging wire passing through them.

25. The delivery device according to claim 24, wherein the plurality of holes include a pair of opposing holes positioned at substantially the same axial position with respect to the longitudinal axis of the tubular member, and the opposing holes are substantially opposite each other.

26. The delivery device according to claim 25, wherein the engaging wire passes through the opposing holes so as to cross the docking area in the engaging configuration.

27. The delivery device according to claim 25 or 26, wherein the plurality of holes further include at least one proximal hole in the tubular member proximal to the pair of opposing holes, and the at least one proximal hole is configured to allow the engaging wire to extend from the lumen along the tubular member to a location outside the lumen.

28. The delivery device according to any one of claims 24 to 27, wherein the plurality of holes include four holes.

29. The delivery device according to any one of claims 24 to 28, wherein the plurality of holes include five holes.

30. The delivery device according to claim 23, wherein the tubular member comprises an elongated receptacle disposed along the side wall of the tubular member.

31. The delivery device according to claim 30, wherein the receptacle extends at least partially within the side wall, and the receptacle has an axial length greater than its width.

32. The delivery device according to claim 30 or 31, wherein the receptacle comprises a shoulder area defined by a recess along the length of the receptacle, which is configured to receive a portion of the heart valve prosthesis, and the shoulder area restricts the freedom of movement of at least one portion of the heart valve prosthesis.

33. The delivery device according to claim 32, wherein the receptacle comprises a pair of opposing rail portions that extend at least partially along the length of the receptacle, and the opposing rail portions are configured to restrict the movement of at least a portion of the heart valve prosthesis laterally.

34. The delivery device according to claim 33, wherein, in the engagement configuration, the loop-shaped section of the engagement wire extends from the lumen of the tubular member through the receptacle to the outside of the lumen in order to engage with the heart valve prosthesis.

35. The delivery device according to claim 34, wherein the tubular member comprises a pair of opposing holes extending from the lumen of the tubular member through the side wall of the tubular member, the pair of opposing holes facing each other substantially opposite to each other around the tubular member, and the loop-shaped section of the engagement wire extends through the receptacle, through the pair of opposing holes, through the lumen, to the opposing outer surfaces of the tubular member.

36. The delivery device according to claim 35, wherein the tubular member has a proximal hole extending through the side wall of the tubular member, and in the engagement configuration, the engagement wire extends sequentially through the proximal hole to the outside of the lumen, through another proximal hole to the inside of the lumen, through the receptacle and docking area to a location outside the lumen, through the pair of opposing holes to the outside of the lumen, and into yet another proximal hole within the lumen.

37. The delivery device according to any one of claims 34 to 36, wherein the tubular member comprises an end cover member disposed at the distal end of the tubular member, and the end cover member is configured to be coupled to the distal end of the engagement wire in order to secure the engagement wire extending from the lumen over the receptacle in order to facilitate engagement with the heart valve prosthesis in the engagement configuration.

38. The delivery device according to claim 37, wherein the end cover member is releasably coupled to the end cover member.

39. The delivery device according to claim 38, wherein the end cover member is bonded to the end cover member by adhesive or mechanical means.

40. The delivery device according to any one of claims 21 to 39, wherein the engaging wire comprises a pull wire and a loop wire, the loop wire having a hole structure into which the pull wire can extend in the engaging configuration, the pull wire being retractable proximal to disengage from the hole structure to allow separation of the pull wire from the loop wire, and the pull wire and the loop wire being retractable proximal to the docking area to allow disengagement of the gripping mechanism from the heart valve prosthesis.

41. The delivery device according to claim 40, wherein each gripping mechanism comprises a tubular member on which the docking area is disposed, and the tubular member comprises a lumen configured to receive the pull wire and the loop wire when the pull wire and the loop wire retract proximally.

42. The delivery device according to claim 41, wherein the tubular member comprises a pair of opposing holes extending from the lumen of the tubular member through the side wall of the tubular member, the pair of opposing holes facing each other substantially opposite to each other around the tubular member, the loop wire extending through the docking area and through the pair of opposing holes, and the loop wire being engaged by the pull wire within the lumen of the tubular member.

43. An artificial heart valve delivery device for delivering a heart valve prosthesis, wherein the device is A delivery device comprising: a gripping mechanism having a longitudinal axis; a tubular member having a lumen; a docking hole extending into the lumen through the side wall of the tubular member; and an engaging wire extending through the lumen toward the docking hole, wherein the engaging wire is configured to pass through and engage with a slot or hole in an anchor tab of the heart valve prosthesis, the engaging wire extending substantially parallel to the longitudinal axis, and the anchor tab extending substantially laterally with respect to the longitudinal axis, thereby facilitating engagement between the gripping mechanism and the heart valve prosthesis in an engagement configuration, and the engaging wire being retractable proximal to the slot or hole in the anchor tab in an engagement configuration to disengage the gripping mechanism from the heart valve prosthesis.

44. The delivery device according to claim 43, wherein the engagement wire includes a straight wire.

45. The delivery device according to claim 43 or 44, wherein the docking hole extends laterally with respect to the longitudinal axis along the side wall of the tubular member.

46. The delivery device according to any one of claims 43 to 45, wherein the device comprises a plurality of gripping mechanisms, and the docking hole of each gripping mechanism faces away from the other gripping mechanisms.

47. An artificial heart valve delivery device, The gripping mechanism comprises a longitudinal axis, a tubular member having a lumen and an open end, and an engaging wire extending through the lumen toward the open end, wherein the engaging wire has a distal end segment having a protrusion or recess configured to abut against each recess or protrusion of the anchor tab of the heart valve prosthesis to form a component connection, In the engagement configuration, the distal end segment and the anchor tab overlap longitudinally within the lumen, and the movement of the distal end segment and the anchor tab is radially constrained by the lumen, thereby limiting the movement of the distal end segment relative to the anchor tab. A cross-sectional profile smaller than the inner diameter of the lumen is collectively defined. A delivery device wherein the distal end segment of the engagement wire is movable distally from the lumen so that the distal end segment and the anchor tab are radially offset from each other to form a disengagement configuration, allowing the anchor tab to move freely away from the engagement wire in order to disengage the heart valve prosthesis from the gripping mechanism.

48. The delivery device according to claim 47, wherein the distal end segment of the engaging wire comprises an elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

49. The delivery device according to claim 47 or 48, wherein the distal end segment of the engagement wire comprises a pair of elongated prongs, each elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

50. The delivery device according to claim 49, wherein each elongated prong is provided with a lateral bump, each lateral bump extending radially from the surface of the elongated prong in a direction away from both elongated prongs, and the lateral bump is configured to contact the inner surface of the lumen in order to maintain engagement between the distal end segment of the heart valve prosthesis and the anchor tab.

51. The delivery device according to any one of claims 47 to 50, wherein the distal end segment comprises a double opposing hook configured to engage with the anchor tab of the heart valve prosthesis.

52. An artificial heart valve system comprising a delivery device according to any one of claims 47 to 50 and a heart valve prosthesis including an anchor tab, wherein the anchor tab has an elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

53. An artificial heart valve system comprising a delivery device according to any one of claims 47 to 52 and a heart valve prosthesis including an anchor tab, wherein the anchor tab has a pair of elongated prongs, each elongated prong having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

54. The system according to claim 53, wherein each elongated prong is provided with a lateral bump, each lateral bump extending radially from the surface of the elongated prong toward both elongated prongs, and the lateral bump is configured to contact the inner surface of the lumen in order to maintain engagement between the distal end segment of the heart valve prosthesis and the anchor tab.

55. The system according to claim 53 or 54, wherein the anchor tab comprises a double opposing hook configured to engage with the distal end segment of the engagement wire in the engagement configuration.

56. An artificial heart valve delivery device, Equipped with a gripping mechanism, The gripping mechanism, A tubular member having a lumen, a lateral hole extending from the lumen to the outer surface of the tubular member, and an open end, The engagement wire extends through the lumen toward the open end, and has a distal end segment configured to at least partially overlap longitudinally with the anchor tab of the heart valve prosthesis positioned within the lumen, (i) The engagement position is a first position in which the distal end segment overlaps longitudinally with the anchor tab in the lumen, creating an interference fit within the lumen, causing the engagement wire or the engagement structure coupled to the anchor tab to protrude into the lateral hole of the tubular member, thereby restricting the longitudinal movement of the anchor tab relative to the tubular member. (ii) A delivery device in which, in the disengaged position, the distal end segment is positioned at a second position proximal to the first position, and the distal end segment and the anchor tab release the interference fit, allowing the engaging structure to be pulled out of the lateral hole, thereby allowing longitudinal movement of the anchor tab relative to the tubular member.

57. The delivery device according to claim 56, wherein the distal end segment of the engaging wire includes a zigzag section having first and second bends, wherein at the engaging position, the first bend is configured to be received in the lateral hole of the tubular member, and the second bend is configured to engage with the hole of the anchor tab.

58. The delivery device according to claim 57, wherein the distal end segment includes a linear, most distal section located distal to the first and second bends, which longitudinally overlaps with the anchor tab in the lumen at the engagement position, and is configured to help create the interference fit.

59. The delivery device according to claims 56 to 58, wherein the distal end segment of the engaging wire has a tapered cross-sectional profile that decreases distally.

60. The delivery device according to claim 59, wherein the distal end segment comprises a wedge section that decreases distally.

61. The delivery device according to claim 59 or 60, wherein the distal end segment comprises a flat surface configured to abut against the anchor tab.

62. An artificial heart valve system comprising a delivery device according to any one of claims 56 to 61 and a heart valve prosthesis having an anchor tab, wherein the anchor tab comprises an elongated body having a projection extending laterally with respect to the longitudinal axis of the elongated body, the projection projecting into the lateral hole of the tubular member, and configured to restrict the longitudinal movement of the anchor tab relative to the tubular member when the anchor tab is in the engagement position with the engagement wire of the delivery device.

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