Heart valve prosthesis delivery system

Abstract

A heart valve prosthesis delivery device may include an engagement mechanism that may securely engage and securely release a heart valve prosthesis carried by it. The delivery device may have a docking region defining a longitudinal axis and a bond wire extending along the longitudinal axis. The bond wire may have an engaged position in which the bond wire extends through the docking region to engage with the heart valve prosthesis. The bond wire may also be moved to a disengaged position to allow the heart valve prosthesis to disengage from the docking region.

Description

[0001] Cross-reference to related applications

[0002] This application requires U.S. Provisional Application No. filed on March 30, 2023.

[0003] Priority and benefits of U.S. Provisional Application No. 63 / 455,943, which relates to International Application No. PCT / US2019 / 012406 and International Application No. PCT / US2019 / 012408, filed January 4, 2019, the entire contents of each of which are incorporated herein by reference. Technical Field

[0004] This disclosure relates to devices, systems, and methods for percutaneous delivery and implantation of heart valve prostheses. The valve delivery device can be securely held and delivered in a compressed state within a sheath to a defective native valve and released in situ. Background Technology

[0005] Heart valve prostheses are used to replace damaged or diseased heart valves. In vertebrates, the heart is a muscular organ with four chambers: the left and right atria, and the left and right ventricles, each with its own unidirectional valve. Native heart valves are identified as the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve. Heart valve prostheses can be used to replace any of these native valves, although repair or replacement of the aortic or mitral valve is more common because they are located on the left side of the heart where the pressure is greatest.

[0006] Conventional heart valve replacement surgery involves accessing the heart in the patient's chest cavity through a longitudinal incision in the thoracic cavity. For example, a median sternotomy requires cutting open the sternum and forcing the two opposing rib cage halves apart to allow access to the chest cavity and heart. Cardiopulmonary bypass is then performed on the patient, which involves stopping the heart to allow access to the ventricles. This open-heart surgery is particularly invasive and involves a long and difficult recovery period.

[0007] The foregoing examples and related limitations of the prior art are intended to be illustrative rather than exclusive. Further limitations of the prior art will become apparent to those skilled in the art upon reading the specification and studying the accompanying drawings. Summary of the Invention

[0008] This disclosure relates to heart valve prostheses, delivery devices, and actuation handles that facilitate the delivery of heart valve prostheses to defective native valve structures (such as aortic valves) within a patient. In some embodiments, delivery may be performed using a transcatheter approach.

[0009] The delivery device disclosed herein enables clinicians to more easily deliver and detach heart valve prostheses carried by the delivery device. Using a transvascular approach (such as a transfemoral approach), the delivery device can advance through blood vessels leading to the heart and through the bends of these vessels. According to one aspect of at least some embodiments disclosed herein, it is recognized that as the heart valve prosthesis advances to a target location within the heart, the delivery device must provide a secure engagement between the delivery device and the heart valve prosthesis; however, the delivery device must also be able to reliably detach from and release the heart valve prosthesis at the target location without causing any trauma to the native tissue or damage to the heart valve prosthesis itself. Furthermore, this recognition also notes that few delivery devices have successfully balanced these competing requirements. Therefore, this disclosure addresses these and other problems and provides a significant advancement in ensuring the safety and reliability of operating heart valve delivery devices.

[0010] A heart valve prosthesis delivery device may include an engagement mechanism that can securely engage with and reliably release a heart valve prosthesis carried thereon. The delivery device may have a mating region defining a longitudinal axis and an engagement line extending along that longitudinal axis. The engagement line may have an engagement position in which it extends through the mating region to engage with the heart valve prosthesis. The engagement line may also be movable to a disengagement position to allow the heart valve prosthesis to disengage from the mating region.

[0011] According to some embodiments, surgical procedures for transcatheter aortic valve implantation (TAVI) and / or transcatheter aortic valve replacement (TAVR) are provided. For example, in TAVI surgery, a clinician may anchor a valve anchor of a heart valve prosthesis relative to the aortic valve annulus to guide the placement of the prosthesis leaflet structure. The valve prosthesis may include a prosthesis leaflet, a valve anchor, a valve frame component, and a tethering component that allows the valve anchor and frame component to be placed in series in a delivery device to reduce the overall cross-sectional profile of the delivery device. According to some embodiments, the valve anchor may be coupled to one or more gripper mechanisms of the delivery device. The gripper mechanism may be configured to include one of a variety of unique structures disclosed herein that both securely engage with a portion of the valve anchor and allow reliable release of the valve anchor from the unique structure.

[0012] Further embodiments of the apparatus and methods of the present invention will become apparent from the following description, drawings, examples, and claims. It will be understood from the above and following description that each feature described herein, as well as each and every combination of two or more such features, is included within the scope of this disclosure, provided that the features included in such combinations do not contradict each other. Furthermore, any feature or combination of features may be explicitly excluded or omitted from any embodiment of this disclosure. Further aspects and advantages of this disclosure are set forth in the following description and claims, particularly when considered in conjunction with the appended examples and drawings.

[0013] Additional features and advantages of this subject matter will be set forth in the following description, and will be apparent in part from the description, or may be learned by practice of the subject matter. The advantages of this subject matter will be realized and obtained through the structures particularly pointed out in the written description, its embodiments, and the accompanying drawings.

[0014] Certain features of valve prostheses, delivery devices, actuation handles, other devices, systems, and methods implemented using the valve prostheses, delivery devices, actuation handles, other devices, systems, and methods discussed in this disclosure may be implemented, for example, in International Application No. PCT / US2019 / 012406 and International Application No. PCT / US2019 / 012408, filed January 4, 2019, the entire contents of each of which are incorporated herein by reference.

[0015] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and are intended to provide further explanation of the technical subject matter. Attached Figure Description

[0016] Various features of exemplary embodiments of the present invention are described below with reference to the accompanying drawings. The illustrated embodiments are intended to show, and not limit, the invention. The drawings include the following figures:

[0017] Figure 1 The delivery of a valve prosthesis (artificial valve) using a valve delivery device in a transfemoral retrograde approach, according to some embodiments, is illustrated.

[0018] Figure 2 A valve prosthesis according to some embodiments is shown.

[0019] Figure 3 It is loaded onto the valve delivery device according to some embodiments. Figure 2 A partial lateral cross-sectional view of the valve prosthesis.

[0020] Figure 4 According to some embodiments Figure 2 A perspective view of the valve delivery device, showing the gripper mechanism engaged with the valve anchor and in an enlarged state.

[0021] Figure 5A According to some embodiments Figure 3 An enlarged perspective view of the valve delivery device shows the gripper mechanism for engaging the valve anchor.

[0022] Figure 5B According to some embodiments Figure 3 An enlarged perspective view of the valve delivery device, with the tubular components of the gripper mechanism shown in dashed lines to illustrate the internal parts of the gripper mechanism.

[0023] Figure 6A and Figure 6B According to some embodiments Figure 5A A cross-sectional view of the valve delivery device.

[0024] Figures 7A to 7D Illustrations are shown according to some embodiments Figure 5A The process of disengaging the valve delivery device.

[0025] Figure 8 An alternative gripper mechanism in an engaged state is shown according to some embodiments.

[0026] Figure 9 Another gripper mechanism in an engaged state is shown according to some embodiments.

[0027] Figure 10 Another gripper mechanism in an engaged state is shown according to some embodiments.

[0028] Figure 11 Another gripper mechanism according to some embodiments is shown.

[0029] Figures 12A to 12E Another gripper mechanism and its disengagement process according to some embodiments are shown.

[0030] Figure 13 Another gripper mechanism in a disengaged state is shown according to some embodiments.

[0031] Figure 14 Another gripper mechanism in an engaged state is shown according to some embodiments.

[0032] Figure 15A and Figure 15B Another gripper mechanism and its disengagement process according to some embodiments are shown.

[0033] Figure 16A and Figure 16B Another gripper mechanism and its disengagement process according to some embodiments are shown.

[0034] Figure 17 Another gripper mechanism and its disengagement process according to some embodiments are shown. Detailed Implementation

[0035] In the following detailed embodiments, numerous specific details are set forth to provide a comprehensive understanding of the subject matter. It should be understood that the subject matter can be practiced without some of these detailed embodiments. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject matter.

[0036] Furthermore, while this disclosure sets forth specific details of various embodiments, it will be understood that the description is illustrative only and should not be construed as limiting in any way. Additionally, it is contemplated that although specific embodiments of this disclosure may be disclosed or illustrated in the context of aortic valve prostheses, these embodiments can be used in other cardiac valve prosthesis applications. Moreover, various applications and modifications of these embodiments that will conceive of those skilled in the art are also encompassed by the general concept described herein.

[0037] Various embodiments will now be described more fully below. However, these embodiments may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and its scope will be fully conveyed to those skilled in the art. Therefore, one or more features shown or otherwise disclosed in the embodiments herein may be used interchangeably or incorporated into another embodiment that may not explicitly show or disclose such features(s). Furthermore, unless explicitly stated otherwise, one or more features shown or otherwise disclosed in the embodiments herein may be excluded from such embodiments using techniques in the art.

[0038] Like all heart valves, a healthy aortic valve opens to allow blood to flow and closes to prevent backflow. However, valve disease and dysfunction can lead to regurgitation 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.

[0039] Minimally invasive surgical techniques are developing in which prosthetic valves can be introduced into a patient using a catheter inserted through a small incision that provides access to, for example, the femoral artery or directly to the heart. These implantation techniques have shown promising results in providing treatment options for patients who are not suitable for open surgery. However, challenges remain in this catheter-based delivery of prosthetic valves.

[0040] For example, according to one aspect of at least one embodiment disclosed herein, it is recognized that advancing a conventional tubular delivery device through a blood vessel can stress the vessel wall and pose a risk of damage to the vessel wall. Furthermore, according to one aspect of at least one embodiment disclosed herein, it is recognized that a transcatheter prosthetic valve may not be suitable for patients with aortic regurgitation. Additionally, according to one 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 dilation. Therefore, the implantation and use of conventional prosthetic valves can lead to complications such as vascular injury, moderate to severe paravalvular leakage, valve thrombosis / migration, coronary artery obstruction, and excessive stress due to excessive radial force.

[0041] This disclosure describes various aspects of a heart valve prosthesis that can be delivered to a patient with a defective heart valve. The valve prosthesis may include at least one valve anchor that is movably connected to, movably attached to, flexibly connected to, displaceably connected to, linked to, or coupled to a radially expandable valve support or frame. The valve frame may include a prosthetic valve leaflet or cusp and provide the function of a native heart valve. For example, certain features of a valve prosthesis that can be implemented in conjunction with the prosthesis discussed in this disclosure are further described in U.S. Patent No. 8,366,768, the entire contents of which are incorporated herein by reference.

[0042] Therefore, this disclosure provides several features that may be optionally incorporated into or excluded from any embodiment explicitly discussed or shown herein. Those skilled in the art can perform modifications and combinations of these features to achieve the advantages and benefits discussed herein. Furthermore, while certain modifications or combinations are pointed out or suggested herein, it is contemplated that those skilled in the art may implement or exclude certain aspects or features disclosed herein in developing suitable embodiments or implementations of these teachings. Advantageously, the various embodiments described herein allow for the treatment of patients with aortic regurgitation, allow for precise axial, angular, and radial positioning of the valve prosthesis, minimize valve migration and paravalvular leakage while avoiding damage to the valve annulus, minimize the need for a pacemaker, and reduce the likelihood of coronary artery obstruction.

[0043] Some of these features and benefits of heart valve prostheses and their delivery systems include Figures 1 to 4 As shown. Figure 1The use of the delivery device in a human heart 10 is illustrated. The heart 10 may include an aorta 12 having an aortic arch 14 and an aortic valve 16. The aortic valve 16 may include a plurality of native valve leaflets 18 and separate the aorta 12 from the left ventricle 20. According to some embodiments, a clinician may operate a handle actuator 50 to control the delivery and release of a valve prosthesis 100. The valve prosthesis 100 may be carried by the delivery device to advance retrogradely through the aorta 12 until it reaches and is positioned at the native valve leaflet 18 of the aortic valve 16.

[0044] Reference Figure 1 and Figure 2 During delivery of the valve prosthesis 100 to the native valve site, the support frame 102 and valve anchor 104 of the prosthesis 100 can be positioned one after the other as axial displacement units (with or without partial or complete overlap between the anchor and the frame) along the longitudinal axis of the delivery device 200. Unlike a concentric arrangement, this configuration allows for a more radially compact configuration of the components of the valve prosthesis 100, resulting in a much smaller cross-section and facilitating catheter-based delivery. This increases the flexibility of the delivery device 200, enabling it to advance along the lead through the tortuous geometry of the circulatory system, particularly the aortic arch 14. In practice, even with a lead-guided delivery device, the aortic arch 14 presents a difficult obstacle due to its abrupt and highly curved nature. This is typically a limiting constraint for some procedures or delivery devices. However, various benefits and advantages are available according to some embodiments disclosed herein, such as Figure 1 As shown, the delivery device 200 can advance over the aortic arch 14 to a target location in the region of the aortic valve 16.

[0045] like Figure 1As shown, once the valve anchor 104 is in the desired position, the support frame 102 can be released from the distal carrier assembly and expand to juxtapose with the internal orientation of the native valve leaflet 18 and the valve anchor 104, thereby clamping the native valve leaflet 18 between the support frame 102 and the valve anchor 104. Advantageously, by clamping the native valve leaflet 18 between the support frame and the valve anchor, the valve prosthesis 100 can reduce its dependence on radial force retention. Furthermore, by clamping the native valve leaflet 18 between the support frame and the valve anchor, the likelihood of the native valve leaflet 18 obstructing the coronary ostium is reduced, which may be beneficial for patients with low coronary ostial distance and patients with existing valve prostheses who may require a new valve prosthesis (valve-in-valve application) within their existing valve prosthesis. The support frame and valve anchors can thus expand to contact the aortic valve 16, thereby applying a sustained outward force to the native valve leaflet 18 and the aortic valve annulus 22. Thereafter, the prosthetic valve leaflet of the prosthesis 100 can begin to function in the desired manner and provide the same operation as the native valve.

[0046] According to some embodiments, this disclosure also provides a handpiece actuator that can be used to control the operation of the delivery device of this disclosure and allow clinicians to reliably and accurately control the delivery of valve prostheses. Figure 1 Features and operation of a handle actuator 50 operable for delivering a valve prosthesis according to some embodiments are shown.

[0047] Figure 1 A handpiece actuator 50 is shown, which can control one or more functions of a delivery device (e.g., delivery device 200 discussed herein) for delivering a valve prosthesis (e.g., the heart valve prosthesis 100 discussed herein). The handpiece actuator 50 may include multiple actuators or movable elements, such as knobs or buttons. The movable elements may allow a clinician to control one or more operations of the delivery device 200. The handpiece actuator 50 may include a control handle 52 having a longitudinal axis 54. The handpiece actuator 50 may also be referred to as a control unit. In some embodiments, the handpiece actuator 50 may be coupled to a second core member (e.g., Figure 3 (As shown in the diagram). The control handle 52 can support the actuator and be held by the clinician during surgery.

[0048] In some embodiments, such as Figure 1As shown, the handle actuator 50 may include 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 may be used to manipulate the delivery device 200, the second movable element 58 may be used to release the valve anchor, the third movable element 60 may be used to release the nosecone or valve frame, and the fourth movable element 62 may be used as a toggle lock. 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.

[0049] Optionally, in some embodiments, one or more of the movable elements (such as the second movable element 58 and / or the third movable element 60) may include a push-button or slider safety switch 64 to prevent unintentional rotation of the movable element. The safety switch 64 may be configured as a resilient push-button or slider mechanism that can be actuated to release a lock that provides resistance to rotational or translational movement of the respective movable element. In some embodiments, the movable element may have a raised feature that provides visual and tactile indication of rotational position, allowing the user to operate the device without looking at it, which may facilitate tactile engagement and actuation by clinicians. Other features of the handle actuator 50 and methods for operating the handle actuator 50 are discussed and illustrated in U.S. Patent Nos. 11,090,156 and 11,083,577, the entire contents of each of which are incorporated herein by reference.

[0050] Now for reference Figure 2 Various configurations of the valve prosthesis 100 and its components are shown. The valve prosthesis 100 can be delivered to a patient using a suitable delivery device, including embodiments of the delivery devices disclosed herein. The valve prosthesis 100 may include a support frame 102 and a valve anchor 104, the support frame 102 being movably connected to, movably attached to, flexibly connected to, displaceably connected to, linked to, or coupled to the valve anchor 104.

[0051] The valve prosthesis 100 can be configured such that its components advance in series while remaining movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to each other, thereby minimizing the pass profile or cross-section of the delivery system. The interconnection of the components of the valve prosthesis 100 can allow varying degrees of movement and can be configured to provide engagement or retention positions with limited ranges of motion. In some embodiments, the engagement position can also provide a preset relative positioning of the components of the valve prosthesis 100 to facilitate proper placement and release of the valve prosthesis 100. Additionally, some embodiments provide clinicians with a high degree of control and enhance the manipulation of the valve prosthesis 100 when implanted at the target location.

[0052] In some embodiments, the valve anchor 104 may be coupled to the support frame 102 when the support frame 102 is in a compact configuration prior to delivery and expansion. In some embodiments, the valve anchor 104 is not secured to the support frame 102. Furthermore, the valve anchor 104 may be detached from the support frame 102, or may be formed separately from the support frame 102 and subsequently coupled to it. Thus, although at least a portion of the valve anchor 104 (e.g., the anchor leg) may contact or otherwise reversibly attach to or connect to the support frame 102, no portion of the valve anchor 104 is secured (e.g., welded or otherwise irreversibly adhered) to the support frame 102. In other words, the valve anchor 104, which may contact or otherwise reversibly attach to the support frame 102, is not irreversibly secured to the support frame 102.

[0053] Furthermore, upon reaching the target location, the valve anchor 104 can be movably coupled to the support frame 102 in such a way that it prevents the entire valve anchor 104 from radially displacing from the support frame 102 when the valve anchor 104 initially expands. For example, during the initial “landing” of the valve anchor 104 on the native valve structure at the target location, a portion of the valve anchor 104 may be radially displaced from the support frame. In some embodiments, the support frame 102 may unfold or expand within the native heart valve structure, and the valve anchor 104 may become sandwiched between the support frame and the native valve tissue, thereby becoming at least partially and possibly completely secured. The valve anchor 104 can be used to hold the expanded support frame 102 in place within the native valve structure.

[0054] Alternatively, the support frame 102 may be referred to as a valve frame or valve support frame. Figure 2A support frame 102, aligned with and expanding within a valve anchor 104, is shown. This support frame 102 is configured to be released and expanded within the native valve structure when the prosthesis 100 is in place. The native valve structure includes a valve annulus or valve leaflets. This expansion configuration is used to secure the valve prosthesis 100 within the native valve annulus by engaging with the native valve structure. In some embodiments, the expansion configuration of the valve prosthesis 100 can reduce reliance on radial forces to secure the valve prosthesis 100, applied via the support frame 102 and the valve anchor 104 by clamping or compressing the native valve leaflets between the support frame 102 and the valve anchor 104. Furthermore, as further discussed herein, during implantation of the valve prosthesis 100, the support frame 102 and the valve anchor 104 can move relative to each other in an expanded and / or compressed state to facilitate proper positioning of the prosthesis 100 relative to the native valve annulus and surrounding structures. In fact, the various advantages that the delivery device for the prosthesis 100 disclosed herein can achieve allow clinicians greater precision in placing the prosthesis 100, and make this increased precision easier to achieve.

[0055] refer to Figure 2 The support frame 102 may include an outer surface or external surface and defines a central aperture around a longitudinal axis 120. The longitudinal axis 120 corresponds to the inflow and outflow axes of the prosthesis 100. In some embodiments, the valve prosthesis 100 also includes a plurality of prosthetic leaflets or cusps 106 coupled to the support frame 102. The support frame 102 can provide structural support for the leaflets 106. The leaflets 106 may have a surface defining a reversibly sealing opening for unidirectional flow of fluid through the prosthesis 100. The prosthesis 100 may include three leaflets 106 for a tri-leaflet configuration. As understood, single-leaflet, bi-leaflet, and / or multi-leaflet configurations are also possible. For example, the leaflets may be coupled to the support frame 102 to span and control fluid flow through the lumen of the prosthesis 100. The prosthetic leaflet 106 may include one or more synthetic materials, engineered biological tissues, bioprosthetic valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed / treated tissues, or combinations thereof. In some embodiments, the pericardial tissue is selected from, but is not limited to, the group consisting of bovine tissues, equine tissues, porcine tissues, sheep tissues, human tissues, or combinations thereof.

[0056] Furthermore, in some embodiments, the valve prosthesis 100 may include a sealing member or membrane 108, which may be attached to, for example, the inner and outer surfaces of the support frame 102 and / or surround the support frame 102 by lamination. Thus, the valve leaflets 106 may be coupled to the support frame 102 and / or the membrane 108. In some embodiments, the membrane 108 may restrict blood flow in the region surrounding the valve leaflets 106 such that blood flow occurs only between the valve leaflets 106, thereby passing through the lumen of the prosthesis 100, as in a healthy native heart valve.

[0057] like Figure 2 As shown, the support frame 102 and / or valve anchor 104 may comprise a braided frame, a wire frame, or a laser-cut frame (e.g., a laser-cut tubular mesh). In some embodiments, the support frame 102 and / or valve anchor 104 may comprise 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 comprise those with spring bias. The material used to manufacture the support frame 102 and / or valve anchor 104 may allow the support frame 102 and / or valve anchor 104 to automatically expand to its functional size and shape upon deployment, and also allow the support frame 102 and / or valve anchor 104 to radially compress to a smaller profile for delivery through the patient's vascular system. Examples of suitable materials for the self-expanding components described herein (e.g., support frames, valve anchors, locking members) include, but are not limited to, medical-grade nickel-titanium alloys, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginates, or combinations thereof. Shape memory alloys with superelastic properties, typically made of nickel and titanium in a ratio (often referred to as nitinol), are preferred materials. In some embodiments, the self-expanding component described herein may include materials including, but not limited to, shape memory plastics, polymers, and thermoplastics that are inert in the body. In alternative embodiments, the support frame 102 and / or valve anchor 104 are not self-expanding and may be expanded, for example, using balloon catheters known in the art. Examples of suitable materials for the component described herein include, but are not limited to, stainless steel and titanium. Optionally, the support frame 102 and / or valve anchor 104 may include a radiopaque material to allow visualization under fluoroscopy or other imaging techniques.

[0058] Optionally, the support frame 102 may include one or more hooks 109 that can engage with tissue of the native valve annulus, aortic root, or any other part of the native valve when the support frame 102 expands within the native valve annulus. The hooks 109 can engage with the native valve annulus to secure the prosthesis 100, thereby mitigating any downstream or antegrade migration of the prosthesis 100 during operation.

[0059] The support frame 102 may include a first end 110 and a second end 112. When the prosthesis 100 is deployed within the native valve annulus, the first end 110 may be located upstream of the second end 112. Figure 2 As shown, the first end 110 of the support frame 102 can be shaped as a generally flat cylindrical end, wherein the first vertices 114 of the support frame 102 are generally located in a common plane, which can be oriented substantially perpendicular to the longitudinal axis 120 of the prosthesis 100. Furthermore, the second end 112 can be shaped to include a series of peaks 130 and valleys 132, wherein the second vertices or secondary peaks 136 of the support frame 102 collectively form the contours of the peaks 130 and valleys 132. When the prosthesis is located within the native valve annulus, the peaks 130 and valleys 132 of the second end 112 can be positioned downstream of the first end 110.

[0060] According to some embodiments, such as Figure 2 As shown, the prosthetic leaflet 106 can be coupled relative to the support frame 102 at a position circumferentially aligned with the peak 130 of the second end 112. In some embodiments, the prosthetic leaflet 106 can be coupled to the membrane 108, for example, using ultra-high molecular weight polyethylene sutures. This unique configuration advantageously allows the prosthesis 100 to more fully approximate the native valve structure, allowing for more natural blood flow without restricting or otherwise constraining the movement of the valve leaflet 106, and integrating more seamlessly with the surrounding structures of the heart. In some embodiments, the prosthetic leaflet 106 may include features including, but not limited to, planar features, flat features, three-dimensional features, Bézier curves, or other suitable shapes. Optionally, the prosthetic leaflet 106 can be shaped by being fixed to a leaflet-shaped mandrel.

[0061] The valve anchor 104 may include at least one U-shaped member, sinus locator, valve locator, or valve hanger 140 extending around the longitudinal axis of the valve anchor 104. Figure 2As shown, the valve anchor 104 may include a plurality of blades or U-shaped members 140, such as three U-shaped members 140, but may have fewer or more blades or U-shaped members. In some embodiments, the U-shaped members 140 may be configured to engage or fit within the posterior aortic sinus, left aortic sinus, and right aortic sinus of the native aortic valve. Each U-shaped member 140 may have a peak 142 and a base 144. Each U-shaped member 140 may include a first leg 146 and a second leg 148. The first legs 146 and the second legs 148 of adjacent U-shaped members 140 may interconnect at their peaks 142. Furthermore, the U-shaped members 140 may include shapes other than U-shapes, such as wave-shaped, V-shaped, W-shaped, or Z-shaped. Alternatively, the plurality of valve anchors 104 may each include one or more U-shaped members 140, wherein the plurality of valve anchors 104 cooperate with the aortic sinus to anchor the valve prosthesis as described herein.

[0062] The valve prosthesis 100 may include a connection mechanism 160 interconnecting the support frame 102 to the valve anchor 104. The connection mechanism 160 may include a single continuous strand of material or multiple separate strands of material interconnecting the support frame 102 to the valve anchor 104. Furthermore, the connection mechanism 160 may be attached to one or more locations on the support frame 102 and / or the valve anchor 104 in a sliding, engaging, or fixed manner.

[0063] According to some embodiments, the valve anchor 104 may optionally define one or more engagement regions in one or more portions of the valve anchor 104, wherein the connection mechanism 160 may engage with the one or more engagement regions to limit relative movement between the support frame 102 and the valve anchor 104.

[0064] For example, at the interconnection of the corresponding peaks, the valve anchor 104 may define an engagement region 150. The engagement region 150 may also be referred to as a peak engagement region.

[0065] like Figure 2 As shown, the support frame 102 can be flexibly coupled to the valve anchor 104 via one or more connecting mechanisms 160. The connecting mechanism 160 can be coupled to the support frame 102 and the valve anchor 104, thereby allowing relative movement between the support frame 102 and the valve anchor 104. However, the connecting mechanism 160 can be configured to restrict relative movement between the support frame 102 and the valve anchor 104. In some embodiments, when the connecting mechanism 160 engages in an engagement region 150 of the valve anchor 104 as discussed herein, the engagement region 150 can be used to further restrict relative movement of the support frame 102 relative to the valve anchor 104.

[0066] The valve anchor 104 can therefore be coupled to the support frame 102 to allow axial or longitudinal movement of the valve anchor 104 relative to the support frame 102 while still remaining coupled to the support frame 102. This advantageous feature in some embodiments allows clinicians to independently position the valve anchor 104 relative to the support frame 102. For example, in transcatheter aortic valve replacement, clinicians can independently position the valve anchor 104 to engage the base 144 of the valve anchor 104 into the aortic sinus. The portions of the aortic sinus may include the posterior aortic sinus of the native aortic valve, the left aortic sinus, and / or the right aortic sinus. In some embodiments, the valve anchor 104 can be rotated to align within the respective aortic sinus. In some embodiments, the interconnection of the valve anchor 104 with the support frame 102 can allow the valve anchor 104 to rotate or reposition (such as self-rotation) to align within or relative to the aortic sinus. As discussed further below, the longitudinal and rotational movements of the valve anchor 104 can be facilitated by interconnecting the engagement region 150 of the valve anchor 104 with the controlled component or gripper of the delivery device.

[0067] With the valve anchor 104 "landed" in the corresponding aortic sinus, the interconnection between the valve anchor 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 delivery, the valve anchor 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 the proximal or distal position to a position in which the support frame 102 at least partially overlaps longitudinally with or is concentric within the valve anchor 104. Ranges of various positions are illustrated, for example, in U.S. Patent Nos. 11,090,156 and 11,083,577, the entire contents of each of which are incorporated herein by reference.

[0068] For example, when the support frame 102 is nested within the valve anchor 104, such as Figure 2As shown, the base 144 of the valve anchor 104 may be longitudinally spaced from the first end 110 of the support frame 102 along the longitudinal axis 120 by a distance of approximately 10% to approximately 100%, approximately 25% to approximately 75%, approximately 33% to approximately 100%, approximately 33% to approximately 66%, approximately 25% to approximately 75%, approximately 50% to approximately 75%, or approximately 60% to approximately 70% of the length of the support frame 102. In some embodiments, the support frame 102 may be included in or otherwise completely overlap with the valve anchor 104. In some embodiments, the support frame 102 may have minimal overlap or no overlap with the valve anchor 104. The support frame 102 can be moved along the longitudinal axis 120 to overlap 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 can be in a nested position within the aortic sinus, and the base 144 of the valve anchor 104 can be approximately longitudinally adjacent, coplanar, or spaced apart from the first end 110 of the support frame 102. For example, the valve anchor 104 can be in a nested position when at least one base 144 of the valve anchor 104 contacts or is adjacent to the basal attachments of the native aortic valve leaflet. Furthermore, the first end 110 of the support frame 102 may be longitudinally adjacent to, coplanar with, or spaced apart from the native valve structure (or the virtual ring formed by the basal appendages of the native aortic valve leaflet) or the ventricle-aortic junction.

[0069] The connecting mechanism 160 allows the valve anchor 104 to rotate and move longitudinally relative to the support frame 102. Therefore, despite the presence of the connecting mechanism 160, the valve anchor 104 can rotate relative to the support frame 102. Furthermore, in some embodiments, the connecting 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 connecting mechanism 160 can slide along the U-shaped member 140. In some embodiments, the U-shaped member 140 has a generally arcuate or convex shape (e.g., ...). Figure 2(As shown in the U-shaped member 140), allowing the connecting mechanism 160 to move unrestricted along the geometry of the first leg 146 and the second leg 148 of the U-shaped member 140. When the connecting mechanism 160 is allowed to slide along the first leg 146 and the second leg 148 of the U-shaped member 140, the valve prosthesis 100 can 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 can be maximum because the connecting mechanism 160 can move along the first leg 146 and the second leg 148 of the U-shaped member 140.

[0070] In some embodiments, the connecting mechanism 160 may be fixedly attached or coupled to the support frame 102 and fixedly attached to the valve anchor 104. When the support frame 102 moves relative to the valve anchor 104, the connecting mechanism 160 may elastically and / or plastically extend, bend, or deform. When the connecting mechanism 160 deforms, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 may vary within the range allowed by the deformation of the connecting mechanism 160.

[0071] Now for reference Figure 3 A side cross-sectional view of a valve prosthesis 100 loaded onto a delivery device 200 according to some embodiments is provided. Figure 3 Among the many features shown, the delivery device 200 may include a distal carrier assembly 206 that at least partially houses the support frame 102. Furthermore, Figure 3 The proximal housing 210 of the delivery device 200 can extend over both the valve anchor 104 and the support frame 102. The distal housing 212 of the distal carrier assembly 206 is capable of at least partially accommodating the support frame 102. The proximal housing 210 can be coupled to the first core member 220, and the distal housing 212 can be coupled to the second core member 222. In some embodiments, the distal housing 212 can be threadedly and / or adhesively coupled or bonded to the second core member 222.

[0072] Therefore, according to some embodiments, in Figure 3 In the compression or delivery configuration shown, the connection mechanism (not shown) may extend between the valve anchor 104 and the support frame 102 and be at least partially enclosed within the proximal housing 210 (depending on the attachment point of the connection mechanism to the support frame 102 and the longitudinal extent of the proximal housing 210). Further details of the delivery device and prosthesis are provided in U.S. Patent Nos. 11,090,156 and 11,083,577, the entire contents of each of which are incorporated herein by reference.

[0073] in addition, Figure 3The delivery system is shown to be used to engage with the engagement region 150 of the valve anchor 104, for example, using a control member or gripper 224 to facilitate movement and control of the positioning of the valve anchor 104 during delivery. As discussed in U.S. Patent Nos. 11,090,156 and 11,083,577 (the entire contents of each of these U.S. Patents are incorporated herein by reference), such engagement can hold the engagement region 150 in a common plane that is oriented substantially perpendicular to the longitudinal axis of the delivery device 200.

[0074] In some embodiments, the delivery device may include a gripper mechanism. The gripper mechanism may have one, two, three, four, or more gripper arms or other such components that serve as contact points for contacting corresponding contact points with the valve prosthesis (such as the valve frame or valve anchor of the prosthesis). Thus, the gripper mechanism can be used to securely attach a portion of the valve anchor to the delivery device, allowing clinicians to control the movement, manipulation, and deployment of the valve anchor. The gripper mechanism may use a variety of coupling mechanisms to engage one or more portions or structures of the valve anchor, employing attachment means including mechanical engagement, soluble structures, chemically reactive degradable structures, electrolytically degradable structures, and the like.

[0075] In some embodiments, by engaging the valve anchor (e.g., at the base of the valve anchor), one or more grippers can precisely engage and control the longitudinal position of the valve anchor. Therefore, one or more grippers can be used to control the articulation of the valve anchor as needed by the clinician. For example, one or more grippers may each have independent translational actuation (e.g., relative to each other), which can collectively "manipulate" the valve anchor relative to the system's central axis or delivery axis and away from or towards the system's central axis or delivery axis. Additionally or alternatively, collective and / or individual actuation of one or more grippers can be used to indirectly or directly control or influence the position, shape, and / or movement of the valve frame.

[0076] Figure 4 Aspects of a delivery device 200 according to some embodiments are shown. These figures do not show all components that can be incorporated into the delivery device in the embodiments. However, the features shown in these figures can be incorporated into embodiments of the delivery device to facilitate engagement with valve anchors and / or facilitate the delivery and control of valve anchors during implantation and release at the target location.

[0077] For example, Figure 4An embodiment of a delivery device 200 including a gripper mechanism 202 is shown. The delivery device 200 is shown in a configuration where the valve anchor 104 is partially open but still constrained (“partially deployed”). In some embodiments, the gripper mechanism 202 may include at least one gripper arm. In some embodiments, the gripper arm may include a tubular housing or structure. As shown, the delivery device 200 may have three gripper arms 224a, 224b, 224c, which can engage with the valve anchor 104 and control the longitudinal position of the valve anchor 104.

[0078] In some embodiments, each of the gripper arms 224a, 224b, 224c of the delivery device 200 may include an engagement line movable within the lumen of the tubular housing. The valve anchor 104 may be configured to include an anchor tab extending from the engagement regions 150a, 150b, 150c of the valve anchor 104.

[0079] In some embodiments, the bonding wire may interconnect with one or more portions of the valve prosthesis to provide a releasable connection to the valve prosthesis.

[0080] For example, the suture can be releasably attached to a hole, protrusion, or other structure of the valve anchor. The suture can pass through or around the engagement area of ​​the valve anchor (such as an anchor tab) in a loop-like manner and be released upon clinician actuation to allow the valve prosthesis to disengage from the delivery device.

[0081] In some embodiments, the engagement line may include a distal end comprising a pin, ridge, or projection that may engage with the engagement structure of the anchor tab at the engagement region of the valve anchor. When engaged, the engagement line and the anchor tab may be pulled proximally into the lumen of the tubular housing, thereby fixing the engagement line and the anchor tab relative to each other in both radial and longitudinal directions. However, as the engagement line and the anchor tab are moved outside the lumen of the tubular housing, they may disengage as the valve anchor and the anchor tab expand radially, thereby disengaging the anchor tab from the engagement line. Some aspects of the delivery system, prosthetic valve, and delivery method disclosed herein may be implemented according to features disclosed in the applicant's U.S. Patent Nos. 11,090,156 and 11,083,577, the entire contents of each of which are incorporated herein by reference.

[0082] The suture can be made of metallic or non-metallic materials. In some embodiments, the valve anchor may include surface-treated (passivated) nitinol. In such embodiments, it may be advantageous to make the suture a non-metallic material so as not to damage the surface. As discussed herein, the arrangement and position of the suture can allow the suture to maintain engagement with the valve anchor without requiring or relying on a high-frictional engagement between the suture and the valve anchor. Therefore, in some embodiments, the suture may include a non-metallic material having a low coefficient of friction relative to the valve anchor, thereby allowing the suture to move smoothly and freely when intentionally actuated by a clinician, while avoiding unintentional movement of the suture.

[0083] Alternatively, the bonding wire can include metal, such as nitinol, which may be advantageous because nitinol is not easily kinked or plastically deformed. However, steel or other materials can also be used.

[0084] In some embodiments, the bonding wire may have a diameter of about 0.020" over most of its length to provide stiffness, reduced tension, and responsiveness to proximal actuation during release.

[0085] In some embodiments, the bonding line may be composed of a centerlessly ground nitinol wire at the distal end (e.g., a wire with a length of 30 mm to 50 mm ground at the distal end, ground from a diameter of 0.020" to a diameter of 0.008"; the grinding may occur at a tapered transition). In some embodiments, the ground wire may be a wire connected to an anchor tab.

[0086] The joining wire can be constructed as: a centerless grinding wire (a continuous piece of material); a welding wire (e.g., connecting two wires of different diameters via welding (such as laser welding); a hypotube connected to a small wire at the center and another wire brazed, brazed, or bonded near the distal end of the hypotube (this can utilize the wire to provide the advantages of stiffness of the hypotube and flexibility at the distal end); or a wire that is folded or bent in half and offset at both ends (one end of which extends distally to allow engagement with a valve anchor).

[0087] According to some embodiments, engagement between the delivery device and the valve prosthesis (such as by using an anchor tab) can allow a control member or gripper to engage with the valve anchor for a retrograde or antegrade delivery approach via the femoral artery (as shown in U.S. Patent Nos. 11,090,156 or 11,083,577). For example, the anchor tab can receive a control member or gripper of the valve anchor proximal to the peak to allow the valve anchor to be used for a retrograde (e.g., retrograde via the femoral artery) approach during valve anchor delivery. Furthermore, the anchor holding member can receive a control member or gripper of the valve anchor proximal to the first and second U-shaped members to allow the valve anchor to be used for an antegrade, apical, or transapical approach during valve anchor delivery.

[0088] Various configurations of the engagement region of the anchor tabs of the valve anchor can be used in some of the embodiments disclosed herein. Furthermore, in any of the embodiments disclosed herein, the engagement region may include barbs or hooks through which a connecting mechanism can pass, as discussed in U.S. Patent No. 11,083,577, the entire contents of which are incorporated herein by reference. The barbs or hooks may allow unidirectional movement of the connecting mechanism, and once the connecting mechanism has passed through the barbs or hooks, the barbs or hooks will prevent the connecting mechanism from moving in the opposite direction over the barbs or hooks. As discussed herein, the illustrated embodiments provide a bimodal or concave shape that tends to capture the connecting mechanism during the prosthesis delivery phase. When the connecting mechanism is thus captured, the valve prosthesis 100 can be in a position referred to as the “holding” position.

[0089] During use, after the valve anchor has been released from the proximal sheath and after the valve anchor and valve frame have been released from the delivery device, the gripper mechanism of the delivery device can be configured to compactly reassemble and retract into the guide sheath in order to minimize any damage to the blood vessels through which the delivery device is advanced.

[0090] Now for reference Figures 5A to 7D Various views of a first embodiment of the engagement between the gripper mechanism 300 and the valve anchor 104 are shown, along with engagement and disengagement positions. Figure 5A and Figure 5B The gripper mechanism 300 is shown to include a tubular member 302. Figure 5B (shown as a transparent part) and bonding line 304.

[0091] The engagement line 304 may extend within the lumen 306 of the tubular member 302. The tubular member 302 may include one or more side holes or apertures 310 through which the engagement line 304 may pass to form an interlocking engagement with the valve anchor 104. For example, in some embodiments, the engagement line may extend within the proximal segment of the tubular member and exit the lumen along the distal segment of the tubular member to facilitate engagement with the valve anchor.

[0092] like Figures 5A to 7D As shown in the embodiments, the tubular member 302 may include a plurality of holes (such as two, three, four, five or more) that allow the engagement line 304 to engage with the valve anchor 104. For example, the engagement line 304 may exit and re-enter the lumen 306 to engage with the anchor tab 152 of the valve anchor 104.

[0093] Anchor tab 152 can enter the cavity 306 of tubular member 302 through end opening 312. When anchor tab 152 is positioned in cavity 306, anchor tab 152 can engage with engagement line 304. For example, as Figures 5B to 6B As shown, the engagement wire 304 can pass through the slot or hole 170 of the anchor tab 152. In this configuration, the engagement wire 304 can hold the anchor tab 152 in the engaged position, which ensures that the gripper mechanism 300 is securely engaged with the valve anchor 104. However, when actuated by a clinician, the engagement wire 304 can be retracted proximally within the lumen 306 of the tubular member 302. When the engagement wire 304 is retracted proximally, the end 320 of the engagement wire 304 is pulled through the hole 310 of the tubular member 302 until the end 320 of the engagement wire 304 is also pulled through the slot 170 of the anchor tab 152. This gradual release or disengagement process... Figure 7A and Figure 7B As shown in the diagram, when the joint line 304 is retracted proximally through the lumen 306, the joint line 304 can be pulled back into the lumen 306 of the tubular member 302, and the anchor tab 152 will disengage from the joint line 304.

[0094] The hole 310 may include one or more holes located on the proximal side and / or one or more holes located on the distal side. Figures 5A to 10 Various embodiments utilizing such holes are shown, which allow access to the lumen of the tubular member for engagement with valve anchors.

[0095] For example, Figures 5A to 7D An embodiment is shown in which, as Figure 6BAs shown, the holes are arranged to have a first distal hole 310a and a second distal hole 310b, as well as a first proximal hole 310c and a second proximal hole 310d. In some embodiments, the first distal hole 310a may be diametrically opposed to the second distal hole 310b. In some embodiments, the first proximal hole 310c may be diametrically opposed to the second proximal hole 310d. However, the first proximal hole 310c may be longitudinally offset relative to the second proximal hole 310d.

[0096] To engage the valve anchor, the engagement line may extend through one or both of the distal pairs of holes 310a, 310b and / or one or both of the distal pairs of holes 310a, 310b, and engage with the valve anchor in the engagement region as discussed herein.

[0097] In some embodiments, such as Figure 6B As shown, the end 320 of the mating line 304 can be inserted into the first proximal hole 310c. Therefore, this arrangement can help prevent the end 320 from unintentionally extending into another (or other) of the holes 310a, 310b, or 310d.

[0098] However, in some embodiments, it may be advantageous to make the final hole (i.e., the hole through which the end 320 of the mating line 304 passes when entering the lumen 306) a second proximal hole 310d. Therefore, Figure 6B The arrangement can be reversed, such that the wire 304 initially exits the lumen 306 through the first proximal hole 310c, then re-enters the lumen 306 through the second distal hole 310b to engage 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 this embodiment, positioning the engagement wire 304 through these holes thus allows for the release of the end 320 of the engagement wire 304 from the second proximal hole 310d at a shorter or faster timing.

[0099] According to some embodiments, each of the holes 310 may have a longitudinal axis extending substantially perpendicularly to the longitudinal axis of the tubular member. For example, as Figure 6B As shown, the first distal hole 310a and the second distal hole 310b may each have a longitudinal axis that extends substantially perpendicularly to the longitudinal axis of the tubular member.

[0100] However, as an alternative, in some embodiments, such as Figure 6B As shown in the first proximal hole 310c and the second proximal hole 310d, the hole 310 may have a longitudinal axis extending laterally relative to the longitudinal axis of the tubular member. Figure 6BAs shown, the first proximal hole 310c and the second proximal hole 310d may each have a longitudinal axis extending laterally relative to the longitudinal axis of the tubular member. This lateral alignment of the longitudinal axes can facilitate the movement of the mating line 304 through the hole.

[0101] According to some embodiments, the porous arrangement allows the engagement line 304 to be oriented laterally or perpendicularly relative to the displacement direction of the tab when pulled out of the lumen 306. The illustrated embodiment allows the engagement line to remain stationary and retain or engage the tab even if the end of the engagement line is unintentionally displaced from the final hole.

[0102] After that, as Figure 7C and Figure 7D As shown, the valve anchor can begin to separate from the gripper mechanism 300, causing the anchor tab 152 to retract completely from the lumen 306 of the tubular member 302. Once the anchor tab 152 has left the lumen 306 of the tubular member 302, the valve anchor 104 can freely expand radially relative to the delivery device 200 (not shown).

[0103] and Figures 5A to 7D One of the many advantages associated with the illustrated embodiment is the robust engagement between the gripper mechanism and the valve anchor 104, while also allowing for easy disengagement. This robust engagement is achieved according to the novel embodiments disclosed herein due to the enhanced ability to have precise tolerances between the mating length of the anchor tab within the lumen (e.g., from the mating area of ​​the valve anchor to the distal edge of the anchor tab slot) and the length 324 from the bore of the tubular member to the end opening of the tubular member. These tolerances can be matched to provide precise alignment of the slot and the bore, and to minimize jitter when the anchor tab is inserted into the lumen and engaged by the mating line.

[0104] For example, in some embodiments, such as Figures 6A to 7B As shown, the farthest set of holes 330 can be positioned in substantially identical longitudinal positions along the axis of the tubular member 302, such that the nearest edge of the slot 170 and the farthest set of holes 330 are positioned adjacent to each other or in substantially identical longitudinal positions along the axis of the tubular member 302. This relative positioning of the nearest edge of the slot 170 and the farthest set of holes 30 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 on the engagement line 304 to limit the distal migration of the anchor tab 152 away from the lumen 306 of the tubular member 302. Therefore, by aligning and positioning the farthest set of holes 330 and the slot 170 of the anchor tab 152, the base 144 of the valve anchor 104 can be firmly abutted against and held against the distal end of the tubular member 302 until the engagement line 304 retracts proximally into the lumen 306, thereby releasing the valve anchor 104 from engagement with the gripper mechanism 300.

[0105] The features disclosed herein provide an innovative design that enables clinicians to enjoy the benefits of: a secure engagement of the valve anchor until it needs to be released, and certainty in releasing the valve anchor without causing damage to the valve anchor or native valve structure that may occur unintentionally during the release of the valve anchor (e.g., by requiring torsional, tensile, or bending forces or other destructive movements).

[0106] Furthermore, based on at least some of the embodiments disclosed herein, it has been recognized that these challenges remain unresolved despite years of research and development undertaken by many companies at high cost. Through the embodiments disclosed and suggested herein, the applicant has been able to successfully achieve a solution that successfully minimizes or prevents accidental release of valve anchors or cardiac prostheses during delivery and ensures that the cardiac valve prosthesis is precisely released at the target location to avoid any damage or misalignment of the valve prosthesis during delivery.

[0107] Now for reference Figure 8 This illustrates another embodiment of the gripper mechanism. Similar to... Figures 5A to 7D The embodiment shown, Figure 8 The illustrated embodiment may also include a tubular member having multiple holes and a bonding line that passes through the holes and engages with a portion of the valve anchor.

[0108] like Figure 8 As shown, the gripper mechanism 400 may include a tubular member 402 (shown as a transparent member) and a connecting line mechanism 404 that may extend at least partially within a lumen 406 of the tubular member 402. While the gripper mechanism 400 may share many of the same operating principles and features as the gripper mechanism 300 discussed above, the connecting line mechanism 404 provides a simpler alternative structure and function. Therefore, for the sake of brevity, the discussion of the features and advantages of the gripper mechanism 300, which can also be applied to the gripper mechanism 400, will not be repeated herein.

[0109] Regarding the joining line mechanism 404, some embodiments may provide multiple components, such as a two-part structure that allows independent actuation of the components, in order to provide additional assurance and separate steps during release.

[0110] For example, the engagement wire mechanism 404 may include a pull wire 410 and a loop wire 412. The pull wire 410 and the loop wire 412 may intersect and engage with each other at a distal location along the gripper mechanism 400 (e.g., adjacent to the mating area where the valve anchor engages with the gripper mechanism). As shown, the pull wire 410 and the loop wire 412 may intersect and form a closed loop, or engage with the slot 170 of the valve anchor 104 via the engagement wire mechanism 404.

[0111] Therefore, similar to the embodiments discussed above regarding the gripper 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 412 can pass through the slot 170 of the anchor tab 152 to restrict the axial movement of the anchor tab 152 away from the opening 420 until the clinician disengages the coupling wire mechanism 404, thereby allowing the gripper mechanism 400 to disengage from the valve anchor 104.

[0112] According to some embodiments, the loop 412 may include engagement structures, such as a hole structure 430 extending through or connected to the loop 412. As shown, the loop 412 may be configured to engage or connect to the hole structure 430 along a distal end of the loop 412. The hole structure 430 may be configured to receive a drawwire 410 passing through it, thereby forming a loop that can engage with a slot 170 of the valve anchor 104.

[0113] To disengage the suture mechanism 404 from the slot 170, the clinician can retract the suture 410 proximally, causing it to eventually separate and retract from the bore structure 430, thus separating the suture 410 from the annulus 412. Once separated, the annulus 412 can retract proximally within the lumen 406 and exit the slot 170. In operation, after disengagement from the valve anchor 104, both the suture 410 and the annulus 412 can retract proximally and 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.

[0114] Based on at least some of the embodiments disclosed herein, it is recognized that the gripper mechanism 400 can allow a clinician to operate a separate controller or actuator to control the movement of the pull cord 410 and loop 412, thereby establishing a discrete step of disengaging the pull cord 410 from the loop 412, and subsequently allowing the clinician to perform a final disengagement of the loop 412 from the slot 170. These actions can be performed via the rotation or translation of an actuator or knob of the control handle of the delivery device. This discrete step of disengaging the pull cord 410 from the loop 412 can provide the clinician with additional certainty and control, thereby minimizing any unintentional disengagement or uncertainty about when or whether the disengagement process has begun. This can be advantageous during placement, thus giving the clinician another discrete step during the disengagement process.

[0115] Additionally, some embodiments of the gripper mechanism 400 may be implemented such that the pull cord 410 includes a distal end 440 that extends beyond the hole structure 430 and extends to a location adjacent to the end opening 420, or extends to a location within approximately 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm of the end opening 420. The size and configuration of the distal end 440 may depend on the axial length of the slot 170, the location of the positioning hole 442 of the tubular member 402, and the specifications of the pull cord 410. In practice, according to some embodiments, the pull cord 410 will provide sufficient rigidity to withstand any lateral bending forces exerted by the loop 412, such that the pull cord 410 will not be pulled through the slot 170 and will not inadvertently detach from the loop 412.

[0116] Furthermore, according to some embodiments, the hole structure 430 may have an inner profile or dimension that closely matches the outer profile or dimension of the draw wire 410. According to some embodiments, the outer cross-section or profile of the loop wire 412 and the hole structure 430 may be smaller than the corresponding dimension or profile of the slot 170 in order to allow the loop wire 412 to be pulled through the slot 170.

[0117] For example, according to some embodiments, the hole structure 430 may have an expanded configuration (which may be larger than the corresponding size or profile of the slot 170) when the draw wire 410 is inserted through it, thereby preventing the hole structure 430 from passing through the slot 170 in the expanded configuration. However, after the draw wire 410 is removed from the hole structure 430, the hole structure 430 may be compressed or automatically returned to a contracted configuration that allows it to pass through the slot 170. Therefore, the configuration of the hole structure 430 can facilitate the engagement or disengagement of the engagement wire mechanism 404 with the anchor tab 152.

[0118] Now for reference Figure 9 Another embodiment of the gripper mechanism 450 is shown. The gripper mechanism 450 may include a tubular member 452 and a connecting line 454. Similar to the above regarding... Figures 5A to 7D In the discussed embodiments, the engagement line 454 may comprise a single continuous line passing through the lumen 456 of the tubular member 452 and through the aperture 460 of the tubular member to form a loop engaging a portion of the valve anchor 104. According to some embodiments, the gripper mechanism 450 may be configured such that the tubular member 452 includes a slot or cutout 462 along the outer surface of the tubular member 452. This slot or cutout 462 may include or form a receiving portion 464 having one or more structures formed to complement the shape or structure of the valve anchor 104 and / or the anchor tab 152.

[0119] For example, Figure 9The illustrated receiving portion 464 may include a shoulder region 466 configured to receive the valve anchor 104 therein and restrict longitudinal or axial movement of the valve anchor 104 relative to the tubular member 452. For example, the shoulder region 466 may include a recess or well that allows the valve anchor 104 to be positioned therein and restricts the valve anchor 104's degrees of freedom of movement other than translational and radial movement, which are substantially perpendicular to the longitudinal axis 470 of the tubular member 452. Thus, unless otherwise restricted, the valve anchor 104 may exit the shoulder region or receiving portion 464 in a direction radially away from the longitudinal axis 470, but will be further restricted to movement in other directions (translation or rotation).

[0120] In some embodiments, the engagement line 454 can restrict radial movement of the valve anchor 104, thereby providing a secure engagement between the valve anchor 104 and the gripper mechanism 450. For example, the engagement line 454 can surround the anchor tab 152 and enter a slot 170 in the anchor tab 152, thereby engaging with the anchor tab 152 and the valve anchor 104 to restrict radial movement of the valve anchor in a direction away from the longitudinal axis 470 and from disengagement from the shoulder region 466.

[0121] Optionally, the tubular member 452 may be configured such that the receiving portion 464 includes opposing guide portions 472 extending longitudinally away from the shoulder region 466 and defining a gap between the guide portions 472, the gap being configured to receive at least a portion of the valve anchor (e.g., anchor tab 152) therein. Thus, the guide portions 472 can help limit the degree of movement of the anchor tab 152 and the valve anchor 104 relative to the tubular member 452.

[0122] and Figure 9 One of the advantages associated with the illustrated gripper mechanism 450 is the increased ease of disengaging and separating the valve anchor 104 from the tubular member 452. For example, the delivery device can be configured such that the receiving portion 464 of the gripper mechanism 450 (especially when using multiple gripper mechanisms 450, such as in...) Figure 4In the embodiment of the delivery device shown, i.e., when using three gripper mechanisms, it can be radially outward relative to the longitudinal axis of the delivery device. Therefore, when the receiving portion 464 is radially outward or open in a direction away from the longitudinal axis of the delivery device, the valve anchor 104 can easily expand radially away from the gripper mechanism 450. Thus, once the clinician retracts the intercalation line 454 proximally and disengages it from the slot 170, the valve anchor 104 can be immediately released from the tubular member 452 and expanded to juxtapose with the native tissue of the target area. Therefore, the gripper mechanism 450 will not tend to interfere with the expansion of the valve anchor 104.

[0123] Now for reference Figure 10 The illustrated embodiment, and Figure 9 Similar to the illustrated embodiment, the gripper mechanism 480 may include a tubular member 482 and an engagement line 484 that can co-engage the valve anchor 104. Similar to the gripper mechanism 450, the gripper mechanism 480 may include a receiving portion 486 configured to receive at least a portion of the valve anchor 104 (such as the anchor tab 152) and limit the degree of movement of the valve anchor 104 relative to the tubular member 482. The various features and functions of the tubular member 482 and the receiving portion 486 are consistent with those described above. Figure 9 The features and functions of the tubular member 452 and the receiving part 464 shown are similar and will not be repeated here for the sake of brevity, but are incorporated herein by reference.

[0124] and Figure 9 Compared to the embodiment of the gripper mechanism 450 shown, the gripper mechanism 480 can be configured such that the coupling line 484 includes a distal segment 488 removably coupled to an end cap 490 disposed at the distal end of the tubular member 482. The distal segment 488 of the coupling line 484 can be attached to the end cap 490. This attachment can be achieved via adhesive or mechanical means. In some embodiments, the end cap 490 can be formed on the distal segment 488 of the coupling line 484 prior to the assembly of the gripper mechanism 480 and the valve anchor 104. Furthermore, the end cap 490 can be detached from and attached to the distal portion 492 of the tubular member 482 such that when the coupling line 484 is pulled proximally and the coupling line 484 is separated from the end cap 490, the end cap 490 remains coupled to the distal portion 492 of the tubular member 482.

[0125] According to some embodiments, the end cap 490 and the distal portion 492 of the tubular member 482 may be separate components that are attached or joined to each other during the assembly of the delivery device with a portion of the valve prosthesis. However, the end cap 490 and the distal portion 492 may form a single feature of the tubular member 482 having or forming a cavity configured to receive the distal segment 488 of the engagement wire 484. In some embodiments, the distal segment 488 may be positioned within the cavity 494, wherein the engagement wire 484 is secured to the inner surface of the cavity 494 with or without adhesive. Thus, with sufficient rigidity, the engagement wire 484 can be used to limit radial movement of the valve anchor 104 away from the longitudinal axis of the tubular member 482 (this limitation is at least in part due to the shear strength of the engagement wire 484 adjacent to the cavity 494 into which it is inserted). Furthermore, by utilizing a releasable adhesive to provide a degree of engagement, in the absence of an adhesive (and therefore only friction engagement), or in the case of an interference fit (and high friction engagement), the distal segment 488 of the engagement line 484 can engage and / or be positioned within the cavity 494 in a manner that mitigates unintentional or accidental separation of the distal segment 488 from the cavity 494. This engagement can be overcome by an intentional proximal force (proximal force) applied to the engagement line 484 during the release of the valve anchor 104. Other advantageous features of the gripper mechanism 480 are similar to those described above. Figure 9 The features discussed in the embodiments shown will not be repeated herein for the sake of brevity.

[0126] Therefore, in Figure 10 In the embodiment of the gripper mechanism 480 shown, the coupling wire can be pulled proximally and, with sufficient proximal force applied, the connection between the coupling wire and the end cap 490 can be disengaged. The coupling wire 484 can then be retracted proximally into the tubular member 482, thereby allowing the valve anchor 104 to disengage and separate from the tubular member 482.

[0127] According to yet another embodiment of the gripper mechanism disclosed herein, Figure 11 A gripper mechanism 500 is shown. The gripper mechanism 500 may include a tubular member 502 (shown as a transparent component) having a side hole 504 through which the anchor tab 510 of the valve anchor 512 can be inserted and engaged with the engagement line 530. The gripper mechanism 500 may provide certain advantages over other embodiments disclosed herein, including simplicity of design, minimal components, and direct and simplified movement of its components.

[0128] The bonding line 530 may include a proximal segment 532 and a distal segment 534. The proximal segment may be defined in a different size or specification than the distal segment 534. In some embodiments, the proximal segment 532 may have a smaller specification than the distal segment 534. As described above, in some embodiments, the bonding line 530 may be ground and formed of wires and / or tubes of different diameters, which are joined together, folded together, or combined thereof to achieve the difference in diameter between the proximal segment 532 and the distal segment 534. This difference in size or specification between the proximal segment 532 and the distal segment 534 may allow clinicians to have a greater degree of responsiveness (less or no longitudinal stretching) when retracting proximally or applying proximal force to the bonding line 530 due to the greater tensile strength of the proximal segment 532 relative to the distal segment 534. However, as discussed herein, the distal segment 534 may also provide sufficient tensile strength to reliably disengage from the anchor tab 510.

[0129] according to Figure 11 In the disclosed embodiments, during assembly, the anchor tab 510 can be pre-bent into a generally right-angle configuration or bent into the side hole 504. Therefore, the anchor tab 510 can be the same as the anchor tab 152 shown and described in the various other embodiments disclosed herein, except that the anchor tab 510 is configured in a generally transverse direction relative to the longitudinal axis of the anchor tab 510 or the longitudinal axis of the gripper mechanism 500.

[0130] like Figure 11 As shown, the bent portion of the anchor tab 510 can form a plug or insertion portion 514 of the anchor tab 510, which can be inserted through the side hole 504 and into the lumen 506 of the tubular member 502. The anchor tab 510 may include a slot 516, which can enter the lumen 506 to a depth sufficient to allow the distal segment 534 of the engagement line 530 to be inserted through the slot 516. In this way, the engagement line 530 can engage with the anchor tab 510 and restrain the movement of the anchor tab 510, thereby preventing the anchor tab 510 from leaving the side hole 504.

[0131] During the procedure, the clinician can retract the suture 530 proximally to disengage the distal segment 534 of the suture 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, thereby allowing radial expansion of the valve anchor 512. (As mentioned above...) Figure 9As shown in the gripper mechanism 450, the side hole 504 can open in a direction away from the longitudinal axis of the delivery device, so that when released, the valve anchor 512 can expand freely away from the gripper mechanism 500. Therefore, the gripper mechanism 500 will not tend to interfere with the expansion of the valve anchor 512.

[0132] According to some embodiments, the gripper mechanism and delivery device disclosed herein can also be configured such that the anchor tab of the valve anchor includes a notch or protrusion that can longitudinally overlap or engage with a corresponding protrusion or notch at the distal segment of the junction line. When the anchor tab longitudinally overlaps with the junction line and is confined within the lumen of the tubular member, the anchor tab and the junction line can also be confined to longitudinal movement relative to each other, thereby securing the anchor tab to the gripper mechanism.

[0133] For example, such as Figures 12A to 13 As shown, the gripper mechanism 550 may include a tubular member 552 having a lumen 554, and a connecting line 556 may be positioned within the lumen 554. The connecting line 556 may include a distal end segment 558, a stem end 560, and a contour-reducing segment 562.

[0134] The contour-reducing segment 562 may include a diameter reduced relative to the proximal segment of the adjacent junction line 556. Furthermore, the stem end 560 may include a generally cylindrical member attached to the contour-reducing segment 562, the generally cylindrical member having a larger diameter than the contour-reducing segment 562. However, according to some embodiments, the stem end 560 and the contour-reducing segment 562 may be configured to form a notch or slot in the distal end of the junction line 556, the notch or slot being compatible with or configured to engage with a corresponding protrusion or component of the anchor tab of the valve anchor.

[0135] about Figures 12A to 12E In the embodiment shown, the gripper mechanism 550 can engage with a valve anchor 570 having an anchor tab 572 including a notch 574. The notch can be configured to receive at least a portion therein the stem end 560 of the engagement line 556. Furthermore, as... Figure 12AAs shown, the inner diameter of the lumen 554 can be designed to allow the combined cross-sectional profile or outer profile of the anchor tab 572 and the distal segment 558 of the joining line 556 to fit within the lumen 554 when they overlap longitudinally. Furthermore, when longitudinally overlapping, the stem end 560 of the joining line 556 will be confined to abut against or within the recess 574 of the anchor tab 572, and the contour-reducing section 562 will substantially confine the enlarged end 580 of the anchor tab 572 such that the enlarged end 580 and the distal segment overlap longitudinally. Thus, the anchor tab 572 and the contour-reducing section 562 are radially confined, such that the corresponding structures effectively engage with each other and securely hold the anchor tab 572 within the lumen 554 of the tubular member 552.

[0136] Figures 12B to 12E This illustrates the gradual release and disengagement of the anchor tab 572 from within the lumen 554 of the tubular member 552. (As shown) Figure 12B As shown, the anchor tab 572 engages and is fixed within the cavity 554 in a first position, in which the stem end 560 longitudinally overlaps with the notch 574, and the enlarged end 580 longitudinally overlaps with the contour-reducing section 562. However, as Figure 12C As shown, when the joint line 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 eliminated. Figure 12D As shown, once the radial constraint created by the tubular member 552 is removed, the anchor tab 572 and the distal segment 558 of the joint line 556 can be radially separated.

[0137] After that, as Figure 12E As shown, the junction line 556 can retract proximally relative to the lumen 554 of the tubular member 552 and enter the lumen 554. Then, the valve anchor 570 can freely expand to be juxtaposed with the native tissue at the target site.

[0138] Figure 13 Another embodiment is shown, wherein the valve anchor 590 includes an anchor tab 592 having opposing elongated segments 594, 596 therebetween forming or defining a gap 598. Similar to the above regarding... Figures 12A to 12E In the discussed embodiment, the gap 598 can be configured to include corresponding recesses and protrusions that substantially correspond to the shapes of the stem end 560 and the contour-reducing section 562 of the joining line 556. (As described above regarding...) Figures 12A to 12EThe discussion described herein, which is incorporated herein by reference and will not be repeated here for the sake of brevity, describes that the anchor tab 592 can longitudinally overlap the distal segment 558 of the engagement line 556 within the cavity 554 of the tubular member 552. In this position, the anchor tab 592 will be securely engaged with the engagement line 556 and prevent disengagement from the gripper mechanism 550. Furthermore, as per [the relevant information]... Figures 12B to 12E The steps shown and discussed can similarly push the anchor tab 592 out of the lumen 554 and release it from engagement with the engagement line 556.

[0139] Figures 12A to 13 The illustrated embodiments show additional features or components for the anchor tabs and the engagement line, which allow for a simplified structure to utilize the interference fit between the engagement line and the anchor tab within the cavity of the tubular member of the gripper mechanism. Furthermore, according to some embodiments, Figure 13 An advantage of some embodiments of the anchor tab and wire arrangement shown is that each gripper connection can be made individually via a temporary engagement by simply pressing the anchor tab onto the wire or gripper mechanism until the two notched legs snap onto the stem end 560. Once all three connections are completed, the handle can be actuated to pull all three wires into the corresponding tubular members, thereby effectively locking or closing the engaged stem end 560 within the gap 598 at the widest portion of the anchor tab 592. This arrangement simplifies the connection by providing a temporary connection at each wire, followed by a common locking actuation during assembly. This can advantageously provide simplified mechanical operation and easier assembly.

[0140] Furthermore, some embodiments may optionally include additional interference fit mechanisms that radially engage with the anchor tabs of the valve anchor within the lumen of the tubular member. For example, Figures 14 to 15B The diagram illustrates such a proximal retraction structure, which can be incorporated into a bonding line, or its function can be performed by the bonding line to produce some radial contraction or interference. These additional embodiments illustrate the principles of other components and constructions that can be prepared using aspects of some embodiments.

[0141] For example, Figure 14 An embodiment of a gripper mechanism 600 is shown, which includes a tubular member 602 having a lumen 604 and a connecting line 606 disposed within the lumen 604. The connecting line 606 may include a bend segment 608 at its distal end. The bend segment 608 may have a configuration in which the connecting line 606 deviates from a generally straight configuration to have one or more bends along the length of the connecting line 606 in the bend segment 608.

[0142] For example, the tortuous section 608 can be formed to have at least two, at least three, or more bends. Figure 14 As shown, the zigzag section 608 may include four bends, thereby causing the joint line 606 to deviate from a generally straight shape or configuration. The bends may form a first bend 610 and a second bend 612, and the joint line 606 may also include a distal section 614 extending distally beyond the second bend 612 within the lumen 604.

[0143] According to some embodiments, the tubular member 602 may include a slot 620 and an end opening 622. When coupled to a valve anchor (such as valve anchor 104), the anchor tab 152 of valve anchor 104 may be inserted into the end opening 622 of the tubular member and engage with a portion of the engagement line 606.

[0144] For example, as shown, 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 segment 614 of the engagement line 606. Thus, the anchor tab 152 can be at least partially constrained radially and longitudinally because the protrusion of the second bend 612 is radially inserted into and received in the slot 170 to form an interference fit between the anchor tab 152 and the distal segment 614 of the engagement line 606 within the lumen 604. Therefore, the size of the lumen 604 can be sufficient to accommodate both the profile or diameter of the engagement line 606 and the profile of the anchor tab 152, such that they longitudinally overlap each other, but because the second bend 612 is inserted into the slot 170, the anchor tab 152 will not be able to... Figure 14 The position shown is away from the end opening 622.

[0145] Furthermore, because the first bend 610 can be inserted into or received through the slot 620 of the tubular member 602, the joint line 606 will tend to be constrained longitudinally or practically relative to the tubular member 602.

[0146] However, according to some embodiments, the junction 606 can be retracted proximally using sufficient proximal force to pull the first bend 610 upward to straighten it and apply a similar pulling / straightening force to the second bend 612. Thus, as the zigzag segment 608 is pulled proximally, the first bend 610 and the second bend 612 can be straightened longitudinally, thereby eliminating the interference fit between the anchor tab 152 within the lumen 604 and the second bend 612 of the junction 606. Successive proximal retraction of the junction will cause the zigzag segment 608 to be pulled to a position proximal to the slot 620 in the direction indicated by arrow 630. When the anchor tab 152 is allowed to leave the end opening 622, the valve anchor 104 and the gripper mechanism 600 will separate and disengage from each other, allowing the valve anchor 104 to expand into juxtaposition with the native valve tissue at the target site.

[0147] Figure 15A and Figure 15B Another embodiment according to some examples is shown, which utilizes a cross-sectional interference fit to engage the anchor tabs of the valve anchor and the gripper mechanism.

[0148] refer to Figure 15A The gripper mechanism 650 may include a tubular member 652 having a lumen 654 and an engagement line 656. The engagement line 656 may include a tapered shape (such as a wedge) that tapers distally, such that the engagement line 656 may longitudinally overlap with the anchor tab 660 of the valve anchor 662. In a first position 670, the tapered section 672 of the engagement line 656 may be pushed into radial engagement to form an interference fit along the proximal portion 674 of the anchor tab 660. According to some embodiments, the tapered section 672 may include a wedge shape or a cone shape.

[0149] As those skilled in the art will understand, when the profile reduction section 672 is pushed distally relative to the anchor tab, the cross-sectional profile of the profile reduction section 672 will increase until the total cross-sectional area of ​​the anchor tab 660 and the profile reduction section 672 matches the inner profile of the lumen 654 of the tubular member 652. In this position, the protrusion 680 extending through the side hole 682 of the tubular member 652 can extend fully into the side hole 682. The presence of the protrusion 680 and its insertion into the side hole 682 tend to ensure that the anchor tab 660 cannot slide or translate relative to the tubular member 652, thereby limiting the relative longitudinal movement of the anchor tab 660 and retaining the anchor tab 660 within the lumen 654 of the gripper mechanism 650.

[0150] However, as Figure 15B As shown, the joint line 656 can retract proximally into the lumen 654, thereby causing the profile-reducing section 672 to retract proximally away from the proximal portion 674 of the anchor tab 660. As the profile-reducing section 672 retracts proximally away from the proximal portion 674 of the anchor tab 660, the proximal portion 674 of the anchor tab 660 can move radially relative to the sidewall or inner surface of the lumen 654, thereby allowing the protrusion 680 to disengage from the hole 682. When this occurs, after the protrusion 680 separates from the hole 682, the anchor tab 660 can be removed and separated from the tubular member 652. Therefore, Figure 15B The separation of the valve anchor 662 from the tubular member 652 is shown.

[0151] Therefore, according to some embodiments, the design is simplified and Figures 14 to 15BThis provides deterministic and simplified operation of the gripper mechanism. Simple proximal retraction of the engagement line and subsequent elimination of cross-sectional interference between the anchor tab and the engagement line allow for easy separation and release of the valve anchor from the gripper mechanism during operation of the deployment device.

[0152] According to yet another embodiment disclosed herein, Figure 16A and Figure 16B Another gripper mechanism according to some embodiments is shown. Figure 16A A gripper mechanism 700 is shown, which may include a tubular member 702 and a distal segment 708. The tubular member 702 has a lumen 704 configured to receive a junction line 706, and the distal segment 708 is configured to restrict the degrees of freedom of movement of the valve anchor 710 when the valve anchor 710 is engaged to the distal segment 708.

[0153] As in other embodiments disclosed herein, the lumen 704 of the gripper mechanism 700 may receive a portion of the valve anchor 710, such as the anchor tab 712 of the valve anchor 710. Then, as Figure 16B As shown, once the anchor tab 712 is in place within the lumen 704, the engagement line 706 can pass in a loop through the proximal hole 720 and the distal hole 722 to engage the slot or hole 724 of the anchor tab 712. The valve anchor 710 will be securely engaged relative to the gripper mechanism 700, restricting relative axial or longitudinal movement between the anchor tab 712 of the valve anchor 710 and the gripper mechanism 700, as in other embodiments disclosed herein.

[0154] However, according to some embodiments, the distal segment 708 and / or lumen 704 can be advantageously configured to restrict additional degrees of freedom of movement of the anchor tab 712 when engaged with the anchor tab 712. Thus, some embodiments tend to provide a more rigid interconnection between gripper devices.

[0155] For example, the lumen 704 can restrict the rotational movement of the anchor tab 712 relative to the lumen 704 and also restrict the rotational movement of the anchor tab 712 within the lumen. This can be achieved by forming the anchor tab 712 with a polygonal cross-section, such as a rectangle, square, or triangle, or other shape with one or more protruding corners, flanges, or tabs, which can engage with a 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 the anchor tab and the lumen, the valve anchor 710 will tend to move in unison with the gripper mechanism 700 of the gripper device, thereby providing greater control and precision when placing the valve anchor 710.

[0156] Therefore, according to some embodiments, the anchor tab 712 may have a profile or cross-sectional shape configured to mate with a corresponding profile or cross-sectional shape of the cavity 704. The cross-sectional shape of the anchor tab may include a rectangle with a chamfer 730, which allows the flat surface formed by the sides of the rectangular shape to provide rotational constraint, while the chamfer 730 allows the anchor tab 712 to slide easily within the cavity 704.

[0157] like Figure 16A As generally shown, according to some embodiments, the chamfer 730 may include a radius of curvature between approximately 10% and approximately 50% of the distance between the sides of the rectangular profile of the anchor tab 712, such as approximately 1 / 7, 1 / 6, 1 / 5, 1 / 4, or approximately 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 may define the length ratio of adjacent sides as approximately 2:3, 1:2, 1:3, 1:4, or 1:5.

[0158] In some embodiments, the rectangular profile of the anchor tab 712 may be provided with a tab width that is at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% larger than the width of the slot 724 extending through the anchor tab 712.

[0159] Optionally, such as Figure 17 As shown, the distal section can be formed to include an anchor slot or bay, in which the anchor can be at least partially received to provide further rotational constraint between the gripper mechanism and the valve anchor.

[0160] As shown, the gripper mechanism 750 may include a tubular member 752, which includes a distal section 754. The distal section 754 includes an anchor slot or groove 756 that provides a gap or space between opposing flanges 758. A valve anchor 760 may be received within the anchor slot 756 and fitted into the gap between opposing flanges 758. The generally flat profile of the flange 758 fits along the width or lateral length of the anchor slot 756 on the top and bottom edges of the valve anchor 760 to limit rotational movement between the flange 758 and the valve anchor 760.

[0161] Therefore, in some embodiments, when the anchor tab (not shown) of the valve anchor 760 is received into the lumen of the tubular member 752, the anchor slot 756 can further engage the base 762 of the anchor tab 760 and provide constraint on relative rotational movement between the anchor 760 and the tubular member 752 about the longitudinal axis of the tubular member 752. (As stated above regarding...) Figure 16A and Figure 16BThe embodiments discussed may be implemented in combination with or separately from anchor tabs having a specific cross-sectional profile to provide rotational constraint and engagement with the lumen of the tubular member.

[0162] Figures 16A to 17 As shown in some embodiments, the tubular member may include a rounded (e.g., circular) outer contour along its entire length or at least a portion of its length. Furthermore, some embodiments may have a non-circular outer contour along its entire length or at least a portion of its length.

[0163] In addition, various embodiments in this disclosure show that the lumen of the tubular member can have a generally rounded (e.g., circular) cross-sectional profile or lumen profile. Figure 16A and Figure 16B The tubular member may include a non-rounded (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 rectangular, square, or triangular, or other shape having one or more protruding corners, flanges, or tabs that may engage with a corresponding structure or shape of an anchor tab. This non-rounded lumen profile may be formed along the entire length of the tubular member or at least a portion of its length.

[0164] The shape of at least a portion of the outer contour or the cavity contour can be formed or adjusted by an extrusion process or by post-extrusion heating and deformation to change the outer contour or the cavity contour as needed using an end forming tool, the tubular member being pressed onto the end forming tool to change the outer contour and / or the cavity contour.

[0165] Furthermore, in some embodiments, the rounded or non-rounded outer contour may extend along the entire length or only a portion of the length of the tubular member, while the rounded or non-rounded lumen contour extends along the entire length or only a portion of the length of the tubular member. Thus, the tubular member may have a rounded outer contour that changes to a non-rounded outer contour along with the non-rounded lumen contour.

[0166] Therefore, according to some embodiments, clinicians can manipulate valve anchors by engaging or connecting the gripper to the anchor tabs of the valve anchor. By encapsulating or interconnecting the gripper and anchor tabs side-by-side (e.g., within or against a tubular housing), relative longitudinal, rotational, and / or radial movement of the gripper and anchor tabs can be restricted. To disengage the gripper and anchor tabs, the clinician can retract or advance the engagement line disposed within the gripper. This relative movement can cause or allow misalignment or separation between the gripper and anchor tabs. Once separated, the valve anchor will tend to expand radially outward, thereby disengaging the anchor tabs from the gripper. The gripper can then be retracted or withdrawn into the tubular housing.

[0167] Description of the subject technology as per the terms

[0168] For convenience, various examples of aspects of this disclosure are described as groups of clauses with numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the technical scope of the subject matter. Identifications and reference numerals in the accompanying drawings are provided hereinafter as examples and for illustrative purposes only, and the clauses are not limited by those identifications.

[0169] Clause 1. A heart valve prosthesis delivery device, comprising: a docking region defining a longitudinal axis; and an engagement line extending along the longitudinal axis, the engagement line including a first segment, a second segment, and a looping segment along the engagement line between the first and second segments, the engagement line having: (i) an engagement position, in which the looping segment extends through the docking region and the second segment at least partially overlaps the first segment longitudinally to facilitate engagement between the delivery device and a heart valve prosthesis at the docking region; and (ii) a disengagement position, in which the second segment is positioned distal to the looping segment and the first segment to allow the heart valve prosthesis to disengage from the docking region.

[0170] Clause 2. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines the docking area.

[0171] Clause 3. The delivery device according to Clause 2, wherein the coupling line extends through the lumen.

[0172] Clause 4. The delivery device according to any one of Clauses 2 or 3, wherein the docking region is configured to receive a protrusion or tab of a heart valve prosthesis therein.

[0173] Clause 5. The delivery device according to any one of Clauses 2 to 4, wherein the tubular member includes at least one hole extending through a sidewall of the tubular member into a lumen of the tubular member, and wherein, in the engagement position, an engagement line is positioned within the lumen and extends through the hole.

[0174] Clause 6. The delivery device according to any one of Clauses 2 to 5, wherein the tubular member includes a distal set of holes extending toward the lumen of the tubular member through a sidewall of the tubular member, and an engagement line extending through the distal set of holes to facilitate engagement between the delivery device and a heart valve prosthesis at the mating region.

[0175] Clause 7. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines a mating region, the tubular member including four holes extending from an outer surface of the tubular member to the lumen, wherein: a mating line is arranged to pass through a first hole and a second hole such that a second segment of the mating line is disposed outside the lumen; a mating line is arranged to pass through a second hole and a third hole such that a second segment of the mating line extends through the mating region within the lumen; a mating line is arranged to pass through a third hole and a fourth hole such that a third segment of the mating line is disposed outside the lumen; and a mating line is arranged to pass through a fourth hole such that a fourth segment of the mating line is disposed outside the lumen.

[0176] Clause 8. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines a docking region, the tubular member including four holes extending from an outer surface of the tubular member into the lumen, wherein a proximal and distal segment of a mating line is disposed within the lumen, the mating line passing through the four holes to form a loop segment extending through the docking region within the lumen.

[0177] Clause 9. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines a docking region, the tubular member including a first hole, a second hole, a third hole and a fourth hole extending from the outer surface of the tubular member to the lumen, the first hole and the fourth hole each having a longitudinal axis extending laterally relative to the longitudinal axis of the tubular member, the second hole and the third hole each having a longitudinal axis extending substantially perpendicularly relative to the longitudinal axis of the tubular member.

[0178] Clause 10. The delivery device according to Clause 9, wherein the second and third holes are arranged at substantially the same longitudinal position along the longitudinal axis of the tubular member.

[0179] Clause 11. The delivery device according to any one of Clauses 9 or 10, wherein the first hole is located along the longitudinal axis of the tubular member between the fourth hole and the second and third holes (between the fourth hole and the second and third holes).

[0180] Clause 12. The delivery device according to any one of Clauses 9 to 11, wherein the first hole is longitudinally offset relative to the second, third and fourth holes along the longitudinal axis of the tubular member.

[0181] Clause 13. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines a mating region, the tubular member including a plurality of holes extending from an outer surface of the tubular member to the lumen, and a mating line extending through the lumen and the plurality of holes.

[0182] Clause 14. The delivery device according to Clause 13, further wherein at least one hole is longitudinally offset relative to another hole along the longitudinal axis of the tubular member.

[0183] Clause 15. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen that at least partially defines a docking region, an open end that allows access to the docking region, and a plurality of holes extending from the outer surface of the tubular member to the lumen, the plurality of holes being for allowing an engagement line to extend out of and into the lumen and across the docking region to engage with a portion of the open end of the heart valve prosthesis that extends into the tubular member.

[0184] Clause 16. The delivery device according to any one of the preceding clauses further includes three tubular members, each having a mating area for engaging the valve with the three tubular members.

[0185] Clause 17. The delivery device according to Clause 16 further includes a proximal sheath with three tubular members extending therein, the proximal sheath being retractable to allow the heart valve prosthesis and the three tubular members to expand prior to disengagement of the delivery device from the heart valve prosthesis.

[0186] Clause 18. The delivery device according to any one of the preceding clauses, wherein the docking area includes a housing having an opening for receiving a portion of a heart valve prosthesis to allow coupling between the heart valve prosthesis and the delivery device.

[0187] Clause 19. The delivery device according to any one of the preceding clauses further includes a tubular member having a lumen and a distal pair of holes extending from the outer surface of the tubular member into the lumen, the distal pair of holes being diametrically opposed and positioned at a first longitudinal position along the longitudinal axis of the tubular member, and an engagement line extending through the distal pair of holes into the lumen and across the mating region to allow engagement with a heart valve prosthesis.

[0188] Clause 20. The delivery device according to Clause 19, wherein a first longitudinal position is set at a first distance from the end of the tubular member, wherein the heart valve prosthesis includes an elongated tab having a base and a hole extending through the elongated tab, wherein the first distance is approximately equal to the distance from the edge of the hole to the base, to allow a tight fit between the elongated tab and the tubular member at the engagement position and to minimize relative movement between the elongated tab and the tubular member.

[0189] Clause 21. A heart valve prosthesis delivery device for delivering a heart valve prosthesis, the delivery device comprising: a core member defining a longitudinal axis; a proximal sheath extending over the core member; and a plurality of gripper mechanisms extending along the longitudinal axis within the proximal sheath for engagement with a heart valve prosthesis, each gripper mechanism including a longitudinal axis, an elongated mating region extending along the longitudinal axis, and an engagement line extending along the gripper mechanism, the engagement line including a proximal segment and a looping segment, the looping segment extending transversely through the mating region relative to the longitudinal axis to facilitate engagement between the gripper mechanism and the heart valve prosthesis in an engagement configuration, the engagement line being retractable proximally to retract the looping segment proximally from the mating region for disengagement of the gripper mechanism from the heart valve prosthesis in a disengagement configuration.

[0190] Clause 22. The delivery device according to Clause 21, wherein the plurality of gripper mechanisms includes three gripper mechanisms.

[0191] Clause 23. The delivery device according to any one of Clauses 21 or 22, wherein each gripper mechanism includes a tubular member and a docking area is arranged in the tubular member.

[0192] Clause 24. The delivery device according to Clause 23, wherein the tubular member includes a plurality of holes extending through the sidewalls of the tubular member to the lumen of the tubular member, the plurality of holes being configured to allow a joining line to pass through therein.

[0193] Clause 25. The delivery device according to Clause 24, wherein the plurality of holes includes a pair of opposing holes positioned at substantially the same axial position relative to the longitudinal axis of the tubular member, the opposing holes being substantially diametrically opposed to each other.

[0194] Clause 26. The delivery device according to Clause 25, wherein, in the engagement configuration, the engagement line passes through the opposing hole to span the mating area.

[0195] Clause 27. The delivery device according to any one of Clauses 25 or 26, wherein the plurality of holes further includes at least one proximal hole in the tubular member, the at least one proximal hole being proximal to a pair of opposing holes, the at least one proximal hole being configured to allow a joining line to extend from the lumen and along the tubular member to a location outside the lumen.

[0196] Clause 28. The delivery device according to any one of Clauses 24 to 27, wherein the plurality of holes includes four holes.

[0197] Clause 29. The delivery device according to any one of Clauses 24 to 28, wherein the plurality of holes includes five holes.

[0198] Clause 30. The delivery device according to Clause 23, wherein the tubular member includes an elongated receiving portion arranged along the sidewall of the tubular member.

[0199] Clause 31. The delivery device according to Clause 30, wherein the receiving portion extends at least partially into the sidewall, and the axial length of the receiving portion is greater than the width of the receiving portion.

[0200] Clause 32. The delivery device according to any one of Clauses 30 or 31, wherein the receiving portion includes a shoulder region defined by a recess along the length of the receiving portion, the recess being configured to receive a portion of a heart valve prosthesis therein, the shoulder region restricting at least one degree of freedom of movement of the portion of the heart valve prosthesis.

[0201] Clause 33. The delivery device according to Clause 32, wherein the receiving portion includes a pair of opposing guide portions extending at least partially along the length of the receiving portion, the opposing guide portions being configured to laterally restrict movement of at least a portion of the heart valve prosthesis.

[0202] Clause 34. The delivery device according to Clause 33, wherein, in the engagement configuration, a looped section of the engagement line extends from the lumen of the tubular member through the receiving portion to the outside of the lumen for engagement with a heart valve prosthesis.

[0203] Clause 35. The delivery device according to Clause 34, wherein the tubular member includes a pair of opposing holes extending from the lumen of the tubular member through the sidewall of the tubular member, the pair of opposing holes being generally diametrically opposed to each other around the tubular member, wherein an annular section of the joining line extends through the receiving portion, through the pair of opposing holes, through the lumen and to opposite outer surfaces of the tubular member.

[0204] Clause 36. The delivery device according to Clause 35, wherein the tubular member includes a proximal hole extending through the sidewall of the tubular member, wherein, in the engagement configuration, the engagement line extends sequentially from the lumen through the proximal hole, enters the lumen through another proximal hole, passes through the receiving portion and the mating area to a position outside the lumen, passes through a pair of opposing holes to pass through the lumen and reach the outside of the lumen, and enters yet another proximal hole to enter the lumen.

[0205] Clause 37. The delivery device according to any one of Clauses 34 to 36, wherein the tubular member includes an end cap member disposed at the distal end of the tubular member, the end cap member being configured to engage with the distal end of the engagement line for securing the engagement line extending from the lumen to the receiving portion for engagement with a heart valve prosthesis in an engagement configuration.

[0206] Clause 38. The delivery device according to Clause 37, wherein the end cap member is releasably coupled to the end cap member.

[0207] Clause 39. The delivery device according to Clause 38, wherein the end cap member is adhesively or mechanically coupled to the end cap member.

[0208] Clause 40. The delivery device according to any one of Clauses 21 to 39, wherein the engagement wire includes a pull wire and a loop wire having a hole structure, wherein in the engagement configuration the pull wire is capable of extending through the hole structure, wherein the pull wire is capable of retracting proximally to disengage from the hole structure to allow the pull wire to separate from the loop wire, and the pull wire and loop wire are capable of retracting proximally relative to the mating area to allow the gripper mechanism to disengage from the heart valve prosthesis.

[0209] Clause 41. The delivery device according to Clause 40, wherein each gripper mechanism includes a tubular member, a docking area is arranged in the tubular member, the tubular member including a lumen configured to receive the pull wire and loop when the pull wire and loop are retracted proximally.

[0210] Clause 42. The delivery device according to Clause 41, wherein the tubular member includes a pair of opposing holes extending from the lumen of the tubular member through the sidewall of the tubular member, the pair of opposing holes being generally diametrically opposed to each other around the tubular member, wherein a loop extends through the pair of opposing holes through the mating area, the loop being joined by a drawwire within the lumen of the tubular member.

[0211] Clause 43. A heart valve prosthesis delivery device for delivering a heart valve prosthesis, the delivery device comprising: a gripper mechanism including a longitudinal axis, a tubular member having a lumen, a mating hole extending through a sidewall of the tubular member into the lumen, and an engagement line extending toward the mating hole through the lumen, the engagement line being configured to pass through and engage with a slot or hole in a clasper tang of the heart valve prosthesis, the engagement line extending generally parallel to the longitudinal axis and the clasper tang extending generally laterally to facilitate engagement between the gripper mechanism and the heart valve prosthesis in an engagement configuration, the engagement line being retractable proximally from the slot or hole in the clasper tang for disengaging the gripper mechanism from the heart valve prosthesis in a disengagement configuration.

[0212] Clause 44. The delivery device according to Clause 43, wherein the joining line comprises a straight line.

[0213] Clause 45. The delivery device according to any one of Clauses 43 or 44, wherein the mating hole extends along the sidewall of the tubular member in a direction transverse to the longitudinal axis.

[0214] Clause 46. The delivery device according to any one of Clauses 43 to 45, wherein the delivery device includes a plurality of gripper mechanisms, wherein the mating hole of each gripper mechanism faces away from the other gripper mechanisms.

[0215] Clause 47. A heart valve prosthesis delivery device, comprising: a gripper mechanism including a longitudinal axis, a tubular member having a lumen and an open end, and an engagement line extending through the lumen toward the open end, the engagement line having a distal segment having a protrusion or recess configured to abut against a corresponding recess or protrusion of a latch of a heart valve prosthesis to form a component connection, wherein: in the engagement configuration, the distal segment and the latch longitudinally overlap within the lumen and together define a cross-sectional profile smaller than the inner diameter of the lumen, such that movement of the distal segment and the latch is radially constrained by the lumen to limit movement of the distal segment relative to the latch, and the distal segment of the engagement line is capable of distally displacing out of the lumen to allow the distal segment and the latch to radially displace relative to each other to a disengagement configuration to allow the latch to move freely away from the engagement line, thereby disengaging the heart valve prosthesis from the gripper mechanism.

[0216] Clause 48. The delivery device according to Clause 47, wherein the distal segment of the joining line includes an elongated rod having an enlarged end and a notch, the notch being proximal to the enlarged end and having a smaller cross-sectional profile than the enlarged end.

[0217] Clause 49. The delivery device according to any one of Clauses 47 or 48, wherein the distal segment of the joining line comprises a pair of elongated rods, each elongated rod having an enlarged end and a notch, the notch being proximal to the enlarged end and having a smaller cross-sectional profile than the enlarged end.

[0218] Clause 50. The delivery device according to Clause 49, wherein each elongated rod includes a lateral ridge extending radially from a surface of the elongated rod in a direction away from both elongated rods, the lateral ridge being configured to contact the inner surface of the lumen to maintain engagement between the distal segment and the latch of the heart valve prosthesis.

[0219] Clause 51. The delivery device according to any one of Clauses 47 to 50, wherein the distal segment includes two opposing hooks configured to engage with a clasp of a heart valve prosthesis.

[0220] Clause 52. A heart valve prosthesis system comprising a delivery device according to any one of claims 47 to 50 and a heart valve prosthesis including a handle, the handle having an elongated rod having an enlarged end and a notch, the notch being proximal to the enlarged end and having a smaller cross-sectional profile than the enlarged end.

[0221] Clause 53. A heart valve prosthesis system comprising a delivery device according to any one of claims 47 to 50 and a heart valve prosthesis including a handle, the handle having a pair of elongated rods, each elongated rod having an enlarged end and a notch, the notch being proximal to the enlarged end and having a smaller cross-sectional profile than the enlarged end.

[0222] Clause 54. The system according to Clause 53, wherein each elongated rod includes a lateral ridge extending radially from a surface of the elongated rod in a direction away from both elongated rods, the lateral ridge being configured to contact the inner surface of the lumen to maintain engagement between the distal segment and the latch of the heart valve prosthesis.

[0223] Clause 55. The system according to any one of Clauses 53 or 54, wherein the clasp comprises two opposing hooks configured to engage with the distal segment of the engagement line in an engagement configuration.

[0224] Clause 56. A heart valve prosthesis delivery device comprising: a gripper mechanism including: a tubular member having a lumen, a side hole extending from the lumen to an outer surface of the tubular member, and an open end; and a coupling line extending through the lumen toward the open end, the coupling line having a distal segment configured to at least partially longitudinally overlap with a latch of a heart valve prosthesis positioned within the lumen; wherein, (i) in an engaged position, the distal segment is in a first position longitudinally overlapping with the latch within the lumen to form an interference fit within the lumen, such that an engagement structure coupled to the coupling line or the latch prosthesis protrudes into the side hole of the tubular member, thereby restricting longitudinal movement of the latch prosthesis relative to the tubular member, and wherein, (ii) in a disengaged position, the distal segment is positioned in a second position proximal to the first position, in which the distal segment and the latch prosthesis release the interference fit and allow the engagement structure to retract from the side hole, thereby allowing longitudinal movement of the latch prosthesis relative to the tubular member.

[0225] Clause 57. The delivery device according to Clause 56, wherein the distal segment of the engagement line includes a zigzag section having a first bend and a second bend, wherein, in the engagement position, the first bend is configured to be received within a side hole of the tubular member, and the second bend is configured to engage with a hole in the clasp.

[0226] Clause 58. The delivery device according to Clause 57, wherein the distal segment includes a straight distal section on the distal side of the first bend and the second bend, the straight distal section being configured to longitudinally overlap with the latch within the lumen at the engagement position to facilitate an interference fit.

[0227] Clause 59. The delivery device according to any one of Clauses 56 to 58, wherein the distal segment of the joining line includes a tapered cross-sectional profile that decreases in the distal direction.

[0228] Clause 60. The delivery device according to Clause 59, wherein the distal segment includes a wedge-shaped section that decreases in the distal direction.

[0229] Clause 61. The delivery device according to any one of Clauses 59 or 60, wherein the distal segment includes a flat surface configured to abut a handle.

[0230] Clause 62. A heart valve prosthesis system comprising a delivery device according to Clause 56 and a heart valve prosthesis having a latch, wherein the latch includes an elongated body having a protrusion extending in a transverse direction relative to the longitudinal axis of the elongated body, the protrusion being configured to project into a side hole in a tubular member to restrict longitudinal movement of the latch relative to the tubular member when the latch is in an engaged position with the engagement line of the delivery device.

[0231] Clause 63. A heart valve prosthesis delivery device comprising any one of the features according to any of the preceding clauses.

[0232] Clause 64. A heart valve prosthesis system comprising a heart valve prosthesis and a heart valve prosthesis delivery device comprising any one of the features described in Clauses 1 to 62.

[0233] Clause 65. A method for assembling a heart valve prosthesis delivery device as described in any of the preceding clauses.

[0234] Clause 66. A method of delivering a heart valve prosthesis delivery device as described in any of the preceding clauses, comprising advancing a heart valve prosthesis to a target location within a human heart and releasing the heart valve prosthesis from the delivery device.

[0235] Clause 67. The apparatus, system, and method according to any of the preceding clauses, wherein the anchor tab includes a cross-sectional protrusion or profile configured to engage a corresponding cross-sectional recess or profile of the tubular member to limit relative rotation between the anchor tab and the tubular member when the anchor tab is received within the lumen.

[0236] Clause 68. The apparatus, system, and method according to any of the preceding clauses, wherein the distal end of the tubular member includes an anchor slot configured to receive a portion of a valve anchor therein to limit relative rotation between the valve anchor and the distal end about the longitudinal axis of the tubular member.

[0237] Further consideration

[0238] In some embodiments, any provision of this document may be subordinate to any independent provision or any dependent provision. In some embodiments, any provision (e.g., a dependent or independent provision) may be combined with any other provision (e.g., a dependent or independent provision). In some embodiments, a claim may include some or all of the words (e.g., steps, operations, apparatus, or components) stated in a provision, sentence, phrase, or paragraph. In some embodiments, a claim may include some or all of the words stated in one or more provisions, sentences, phrases, or paragraphs. In some embodiments, some words may be removed from each of the provisions, sentences, phrases, or paragraphs. In some embodiments, additional words or elements may be added to the provisions, sentences, phrases, or paragraphs. In some embodiments, the subject matter technique may be implemented without utilizing some of the components, elements, functions, or operations described herein. In some embodiments, the subject matter technique may be implemented using additional components, elements, functions, or operations.

[0239] The above description is provided to enable those skilled in the art to practice the various constructions described herein. Although the subject matter has been specifically described with reference to various accompanying drawings and constructions, it should be understood that these are for illustrative purposes only and should not be considered as limiting the scope of the subject matter.

[0240] There are many other ways to implement the subject matter. The various functions and elements described herein can be categorized differently from those shown without departing from the scope of the subject matter. Those skilled in the art will readily understand various modifications to these constructions, and the general principles defined herein can be applied to other constructions. Therefore, those skilled in the art can make many changes and modifications to the subject matter without departing from its scope.

[0241] It should be understood that the specific order or hierarchy of steps in the disclosed process is an illustration of an exemplary method. Based on design preferences, it should be understood that the specific order or hierarchy of steps in the process can be rearranged. Some steps may be performed simultaneously. The appended method claims present the elements of the various steps in an exemplary order and are not intended to limit one to the specific order or hierarchy presented.

[0242] As used herein, the term "distal" can refer to a location or orientation away from the point of interest, such as the user or the control unit or region of the delivery system used to deliver the valve prosthesis to the native valve annulus. Conversely, the term "proximal" can refer to a location or orientation closer to the point of interest, such as the user or the control unit or region of the delivery system used to deliver the valve prosthesis.

[0243] As used herein, the phrase “at least one” preceding a series of items, and the terms “and” or “or” used to separate any items, modify the list as a whole, not each member of the list (i.e., each item). The phrase “at least one” does not require selection of at least one of each of the listed items; rather, the phrase allows for meanings including at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0244] Terms such as “top,” “bottom,” “front,” and “rear” used in this disclosure should be understood to refer to any frame of reference, rather than a conventional gravitational frame of reference. Therefore, the top surface, bottom surface, front surface, and rear surface may extend upward, downward, obliquely, or horizontally in a gravitational frame of reference.

[0245] Furthermore, with regard to the terms “comprising”, “having”, etc., used in the specification or claims, this term is intended to be inclusive in a similar manner to the term “comprising,” as interpreted when “comprising” is used as a transitional word in the claims.

[0246] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0247] Unless otherwise specified, references to elements in the singular are not intended to mean "one and only one," but rather "one or more." Male pronouns (e.g., his) include female and neutral 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, do not limit the subject matter, and are not related to the interpretation of the description of the subject matter. All structural and functional equivalents of elements in various constructions described herein that are known or will be known hereafter by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the subject matter. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the foregoing description.

[0248] Although the detailed embodiments contain numerous details, these details should not be construed as limiting the scope of the subject matter, but rather as illustrating different examples and aspects of the subject matter. It should be understood that the scope of the subject matter includes other embodiments not discussed in detail above. Various other modifications, alterations, and variations can be made to the arrangement, operation, and details of the methods and apparatuses of the subject matter disclosed herein without departing from the scope of this disclosure. Unless otherwise stated, references to elements in the singular are not intended to mean "one and only one," but rather "one or more" unless explicitly stated. Furthermore, an apparatus or method does not necessarily solve every problem (or possess every achievable advantage) that can be solved by the different embodiments of this disclosure in order to be covered within the scope of this disclosure. The word "can" and its derivatives as used herein should be understood to mean "possibly" or "optionally," rather than a definitive capability.

Claims

1. A heart valve prosthesis delivery apparatus comprising: a docking region defining a longitudinal axis; and an engagement line extending along the longitudinal axis, the engagement line comprising a first section, a second section, and a looped section interposed between the first section and the second section along the engagement line, the engagement line having: (i) an engaged position in which the looped section extends through the docking region and the second section at least partially longitudinally overlaps the first section to facilitate engagement between the delivery apparatus and a heart valve prosthesis at the docking region, and (ii) a disengaged position in which the second section is positioned distal to the looped section and the first section to allow the heart valve prosthesis to disengage from the docking region.

2. The delivery apparatus of claim 1, further comprising a tubular member having a lumen at least partially defining the docking region.

3. The delivery device of claim 2, wherein, the engagement line extends through the lumen.

4. The delivery device of claim 2 or 3, wherein, the docking region is configured to receive a protrusion or tab of the heart valve prosthesis therein.

5. The delivery device of claims 2-4, wherein, the tubular member includes at least one aperture extending through a sidewall of the tubular member to the lumen of the tubular member, and wherein, in the engaged position, the engagement line is positioned within the lumen and extends through the aperture.

6. The delivery device of claims 2-5, wherein, the tubular member includes a distal-most set of apertures extending through a sidewall of the tubular member toward the lumen of the tubular member, the engagement line extending through the distal-most set of apertures to facilitate engagement between the delivery apparatus and the heart valve prosthesis at the docking region.

7. The delivery apparatus of claim 1, further comprising a tubular member having a lumen at least partially defining the docking region, the tubular member including four apertures extending from an outer surface of the tubular member to the lumen, wherein: the engagement line is arranged to pass through a first aperture and a second aperture such that a first segment of the engagement line is arranged outside of the lumen; the engagement line is arranged to pass through the second aperture and a third aperture such that a second segment of the engagement line extends through the docking region within the lumen; the engagement line is arranged to pass through the third aperture and a fourth aperture such that a third segment of the engagement line is arranged outside of the lumen; and the engagement line is arranged to pass through the fourth aperture such that a fourth segment of the engagement line is arranged within the lumen.

8. The delivery device of any of the preceding claims, further comprising a tubular member having a lumen at least partially defining the docking region, the tubular member including four apertures extending from an outer surface of the tubular member to the lumen, wherein, proximal and distal segments of the engagement line are arranged within the lumen, the engagement line passing through the four apertures to form a looped segment extending through the docking region within the lumen.

9. The delivery device of any of the preceding claims, further comprising a tubular member having a lumen at least partially defining the docking region, the tubular member including a first hole, a second hole, a third hole, and a fourth hole extending from an outer surface of the tubular member to the lumen, the first and fourth holes each having a longitudinal axis extending transversely relative to a longitudinal axis of the tubular member, the second and third holes each having a longitudinal axis extending substantially perpendicularly relative to the longitudinal axis of the tubular member.

10. The delivery device of claim 9, wherein, The second and third holes are disposed at substantially the same longitudinal position along the longitudinal axis of the tubular member.

11. The delivery device of 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 of claims 9-11, wherein, The first hole is longitudinally offset relative to the second, third, and fourth holes along the longitudinal axis of the tubular member.

13. The delivery device of any of the preceding claims, further comprising a tubular member having a lumen at least partially defining the docking region, the tubular member including a plurality of holes extending from an outer surface of the tubular member to the lumen, the engagement wire extending through the lumen and the plurality of holes.

14. The delivery device of claim 13, further wherein, At least one hole is longitudinally offset relative to another hole along the longitudinal axis of the tubular member.

15. The delivery device of any of the preceding claims, further comprising a tubular member having a lumen at least partially defining the docking region, an open end allowing access to the docking region, and a plurality of holes extending from an outer surface of the tubular member to the lumen for allowing the engagement wire to extend out of and into the lumen and across the docking region to engage a portion of the heart valve prosthesis extending into the open end of the tubular member.

16. The delivery device of any of the preceding claims, further comprising three tubular members formed with respective docking regions for engaging a valve with the three tubular members.

17. The delivery device of claim 16, further comprising a proximal sheath in which the three tubular members extend, the proximal sheath being retractable to allow the heart valve prosthesis and three tubular members to expand prior to disengagement of the delivery device from the heart valve prosthesis.

18. The delivery device of any of the preceding claims, wherein, The docking region includes a housing having an opening for receiving a portion of the heart valve prosthesis to allow coupling between the heart valve prosthesis and the delivery device.

19. The delivery device of any of the preceding claims, further comprising a tubular member having a lumen and a distal pair of holes extending from an outer surface of the tubular member into the lumen, the distal pair of holes being diametrically opposed and positioned at a first longitudinal position along a longitudinal axis of the tubular member, the engagement wire extending through the distal pair of holes into the lumen and across the docking region to allow engagement with the heart valve prosthesis.

20. The delivery device of claim 19, wherein, The first longitudinal position is set at a first distance from an end of the tubular member, wherein the heart valve prosthesis includes an elongate tab having a base and a hole extending through the elongate tab, wherein the first distance is approximately equal to a distance from an edge of the hole to the base to allow a close fit between the elongate tab and the tubular member at the engaged position and to minimize relative movement between the elongate tab and the tubular member.

21. A heart valve prosthesis delivery apparatus for delivering a heart valve prosthesis, the delivery apparatus comprising: a core member defining a longitudinal axis; a proximal sheath extending over the core member; and a plurality of gripper mechanisms extending within the proximal sheath along the longitudinal axis for engagement with the heart valve prosthesis, each gripper mechanism including a longitudinal axis, an elongate docking region extending along the longitudinal axis, and an engagement wire extending along the gripper mechanism, the engagement wire including a proximal section and a looped section extending through the docking region just transverse to the longitudinal axis to facilitate engagement between the gripper mechanism and the heart valve prosthesis in an engaged configuration, the engagement wire being retractable proximally to withdraw the looped section proximally from the docking region for disengagement of the gripper mechanism from the heart valve prosthesis in a disengaged configuration.

22. The delivery device of claim 21, wherein, The plurality of gripper mechanisms includes three gripper mechanisms.

23. The delivery device of claim 21 or 22, wherein, Each gripper mechanism includes a tubular member, the docking region being disposed in the tubular member.

24. The delivery device of claim 23, wherein, The tubular member includes a plurality of holes extending through a sidewall of the tubular member to a lumen of the tubular member, the plurality of holes being configured to allow the engagement wire to pass therethrough.

25. The delivery device of claim 24, wherein, The plurality of holes includes a pair of opposing holes positioned at approximately the same axial position relative to the longitudinal axis of the tubular member, the opposing holes being approximately diametrically opposed to each other.

26. The delivery device of claim 25, wherein, In the engaged configuration, the engagement wire passes through the opposing holes to span the docking region.

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

28. The delivery device of claims 24-27, wherein, The plurality of holes includes four holes.

29. The delivery device of claims 24-28, wherein, The plurality of holes includes five holes.

30. The delivery device of claim 23, wherein, The tubular member includes an elongate receptacle disposed along a sidewall of the tubular member.

31. The delivery device of claim 30, wherein, The receptacle extends at least partially into the sidewall, an axial length of the receptacle being greater than a width of the receptacle.

32. The delivery device of claim 30 or 31, wherein, The receptacle includes a shoulder region defined by a recess along a length of the receptacle, the recess being configured to receive a portion of the heart valve prosthesis therein, the shoulder region restricting at least one degree of freedom of movement of the portion of the heart valve prosthesis.

33. The delivery device of claim 32, wherein, The housing includes a pair of opposing rail portions extending at least partially along a length of the housing, the opposing rail portions configured to laterally restrict movement of at least a portion of the heart valve prosthesis.

34. The delivery device of claim 33, wherein, In the engaged configuration, the looped segment of the engagement line extends from a lumen of the tubular member through the housing to an exterior of the lumen for engagement with the heart valve prosthesis.

35. The delivery device of claim 34, wherein, The tubular member includes a pair of opposing apertures extending through a sidewall of the tubular member from the lumen of the tubular member, the pair of opposing apertures being generally diametrically opposed relative to one another about the tubular member, wherein the looped segment of the engagement line extends through the pair of opposing apertures, through the lumen, and to an opposing outer surface of the tubular member.

36. The delivery device of claim 35, wherein, The tubular member includes a proximal aperture extending through the sidewall of the tubular member, wherein, in the engaged configuration, the engagement line extends successively out of the lumen through the proximal aperture, into the lumen through another proximal aperture, through the housing and the docking region to a location exterior of the lumen, through the pair of opposing apertures to pass through the lumen and to an exterior of the lumen, and into yet another proximal aperture to enter the lumen.

37. The delivery device of any of claims 34-36, wherein, The tubular member includes an end cap member disposed at a distal end of the tubular member, the end cap member configured to be coupled to a distal end of the engagement line for securing the engagement line extending from the lumen over the housing to facilitate engagement with the heart valve prosthesis in the engaged configuration.

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

39. The delivery device of claim 38, wherein, The end cap member is adhesively or mechanically coupled to the end cap member.

40. The delivery device of claims 21-39, wherein, The engagement line includes a pull wire and a loop wire, the loop wire having a hole structure through which the pull wire is extendable in the engaged configuration, wherein the pull wire is retractable proximally to disengage from the hole structure to allow the pull wire to separate from the loop wire, the pull wire and the loop wire are retractable proximally relative to the docking region to allow the gripper mechanism to disengage from the heart valve prosthesis.

41. The delivery device of claim 40, wherein, Each gripper mechanism includes a tubular member in which the docking region is disposed, the tubular member including a lumen configured to receive the pull wire and the loop wire when the pull wire and the loop wire are retracted proximally.

42. The delivery device of claim 41, wherein, The tubular member includes a pair of opposing apertures extending through a sidewall of the tubular member from a lumen of the tubular member, the pair of opposing apertures being generally diametrically opposed relative to one another about the tubular member, wherein the loop wire extends through the pair of opposing apertures through the docking region, the loop wire being engaged by the pull wire within the lumen of the tubular member.

43. A heart valve prosthesis delivery apparatus for delivering a heart valve prosthesis, the delivery apparatus comprising: A grasper mechanism including a longitudinal axis, a tubular member having a lumen, a docking hole extending through a sidewall of the tubular member into the lumen, and an engagement wire extending through the lumen toward the docking hole, the engagement wire configured to pass through and engage with a slot or hole of an anchor tab of the heart valve prosthesis, the engagement wire extending substantially parallel relative to the longitudinal axis, and the anchor tab extending substantially transverse relative to the longitudinal axis, to facilitate engagement between the grasper mechanism and the heart valve prosthesis in an engaged configuration, the engagement wire being retractable proximally from the slot or hole of the anchor tab for disengaging the grasper mechanism from the heart valve prosthesis in a disengaged configuration.

44. The delivery device of claim 43, wherein, The engagement wire includes a straight wire.

45. The delivery device of claims 43-44, wherein, The docking hole extends along the sidewall of the tubular member in a direction transverse relative to the longitudinal axis.

46. The delivery device of claims 43-45, wherein, The delivery device includes a plurality of grasper mechanisms, wherein the docking hole of each grasper mechanism faces away from the other grasper mechanisms.

47. A heart valve prosthesis delivery device comprising: A grasper mechanism including 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, the engagement wire having a distal segment with a protrusion or recess configured to abut a corresponding recess or protrusion of an anchor tab of a heart valve prosthesis to form a component coupling, wherein: In an engaged configuration, the distal segment and the anchor tab longitudinally overlap within the lumen and collectively define a cross-sectional profile that is smaller than an inner diameter of the lumen, such that motion of the distal segment and the anchor tab is constrained radially by the lumen to limit motion of the distal segment relative to the anchor tab, and The distal segment of the engagement wire is distally movable out of the lumen to allow the distal segment and the anchor tab to be radially displaced from one another to a disengaged configuration to allow the anchor tab to freely move away from the engagement wire to disengage the heart valve prosthesis from the grasper mechanism.

48. The delivery device of claim 47, wherein, The distal segment of the engagement wire includes an elongated rod having an enlarged end portion and a notched portion proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

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

50. The delivery device of claim 49, wherein, Each elongated rod includes a lateral protuberance radially extending from a surface of the elongated rod in a direction away from both elongated rods, the lateral protuberance configured to contact an inner surface of the lumen to maintain engagement between the distal segment and the anchor tab of the heart valve prosthesis.

51. The delivery device of claims 47-50, wherein, The distal segment includes two opposing hook portions configured to engage the anchor tab of the heart valve prosthesis.

52. A heart valve prosthesis system comprising the delivery device of any one of claims 47-50 and a heart valve prosthesis comprising an anchor tab having an elongated stem with an enlarged end portion and a notched portion proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

53. A heart valve prosthesis system comprising the delivery device of any one of claims 47-52 and a heart valve prosthesis comprising an anchor tab having a pair of elongated stems, each elongated stem having an enlarged end portion and a notched portion proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

54. The system of claim 53, wherein, Each elongated stem comprises a lateral bulge extending radially from a surface of the elongated stem in a direction away from both elongated stems, the lateral bulge configured to contact an inner surface of the lumen to maintain engagement between the distal end segment and the anchor tab of the heart valve prosthesis.

55. The system of claim 53 or 54, wherein, The anchor tab comprises two opposing hook portions configured to engage the distal end segment of the engagement wire in the engaged configuration.

56. A heart valve prosthesis delivery device comprising: a gripper mechanism comprising: a tubular member having a lumen, a side aperture extending from the lumen to an outer surface of the tubular member, and an open end; and an engagement wire extending through the lumen toward the open end, the engagement wire having a distal end segment configured to at least partially longitudinally overlap an anchor tab of a heart valve prosthesis positioned within the lumen; wherein (i) in an engaged position, the distal end segment is in a first position longitudinally overlapping the anchor tab within the lumen to form an interference fit within the lumen, thereby causing an engagement structure coupled to the engagement wire or the anchor tab to protrude into the side aperture of the tubular member and thereby limit longitudinal movement of the anchor tab relative to the tubular member, and wherein (ii) in a disengaged position, the distal end segment is positioned in a second position proximal to the first position, in which the distal end segment and the anchor tab release the interference fit and allow the engagement structure to be withdrawn from the side aperture, thereby allowing longitudinal movement of the anchor tab relative to the tubular member.

57. The delivery device of claim 56, wherein, The distal end segment of the engagement wire comprises a tortuous section having a first bend and a second bend, wherein in the engaged position, the first bend is configured to be received within the side aperture of the tubular member and the second bend is configured to engage a hole of the anchor tab.

58. The delivery device of claim 57, wherein, The distal end segment comprises a straight distal-most section distal to the first bend and the second bend, the straight distal-most section configured to longitudinally overlap the anchor tab within the lumen in the engaged position to contribute to the formation of the interference fit.

59. The delivery device of claims 56-58, wherein, The distal end segment of the engagement wire comprises a tapered cross-sectional profile decreasing in a distal direction.

60. The delivery device of claim 59, wherein, The distal end section comprises a wedge-shaped section decreasing in a distal direction.

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

62. A heart valve prosthesis system comprising the delivery device of 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 protrusion extending in a transverse direction relative to a longitudinal axis of the elongated body, the protrusion configured to protrude into the side aperture of the tubular member to limit longitudinal movement of the anchor tab relative to the tubular member when the engagement line of the anchor tab and the delivery device is in the engaged position.

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