Cardiac valve prosthesis placement system

Description

1 / 78 CARDIAC VALVE PROSTHESIS PLACEMENT SYSTEM CROSS-REFERENCE TO RELATED REQUESTS

[001] This application claims priority and benefit of U.S. Provisional Application No. 63 / 455,943, filed March 30, 2023, which relates to International Application No. PCT / US2019 / 012406, filed January 4, 2019, and International Application No. PCT / US2019 / 012408, filed January 4, 2019, the entirety of each of which is incorporated herein by reference. TECHNICAL FIELD

[002] The present invention relates to devices, systems and methods for percutaneous placement and implantation of a heart valve prosthesis. The valve placement device can be securely retained and placed in a compressed state within a sheath for the defective native valve and released in situ. BACKGROUND

[003] Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrate animals, the heart is a muscular organ with four pumping chambers: the left and right atria and the left and right ventricles, each with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. Prosthetic heart valves can be used to replace any of these naturally occurring valves, although repair or replacement of the aortic or mitral valves is more common, as they reside on the left side of the heart where pressures are higher.

[004] Conventional heart valve replacement surgery involves accessing the heart in the patient's chest cavity through Petition 870250101744, dated 06 / 11 / 2025, page 7 / 124 2 / 78 through a longitudinal incision in the thorax. For example, a median sternotomy requires cutting the sternum and forcing the two opposite halves of the rib cage to spread apart, allowing access to the thoracic cavity and the heart within. The patient is then placed on cardiopulmonary bypass which involves stopping the heart to allow access to the internal chambers. This open-heart surgery is particularly invasive and involves a long and difficult recovery period.

[005] The preceding examples of the related technique and limitations related thereto are intended to be illustrative and not exclusive. Other limitations of the related technique will become apparent to those skilled in the art upon reading the descriptive report and studying the drawings. SUMMARY

[006] The present invention relates to heart valve prostheses, placement devices and drive cables that can facilitate the placement of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve. In some embodiments, placement can be performed using a transcatheter approach.

[007] The placement devices described in this document may allow a physician to more easily place and disengage a transported heart valve prosthesis. The placement device may advance through blood vessels leading to the heart, as well as through tortuosities of such vessels, using a transvascular approach, such as a transfemoral approach. One aspect of at least some of the embodiments described in this document is the understanding that, when advancing a heart valve prosthesis to a target location within the heart, a placement device must provide a secure engagement between the placement device and the heart valve prosthesis; however, the device Petition 870250101744, dated 06 / 11 / 2025, p. 8 / 124 3 / 78 placement device must also be able to reliably disengage and release the heart valve prosthesis at the target site without any trauma to the native tissue or damage to the heart valve prosthesis itself. Furthermore, this insight also notes that few placement devices have successfully balanced these competing needs. Therefore, the present invention addresses these and other problems and provides significant advancements that ensure safety and reliability in the operation of a heart valve placement device.

[008] A prosthetic heart valve placement device may include a coupling mechanism that can securely engage and reliably release a prosthetic heart valve thus transported. The placement device may have a docking area that defines a longitudinal axis and a coupling wire that extends along the longitudinal axis. The coupling wire may have an engaged position in which the coupling wire extends through the docking area to engage with the prosthetic heart valve. The coupling wire may also be moved to a disengaged position to allow disengagement of the prosthetic heart valve from the docking area.

[009] According to some modalities, procedures are provided for transcatheter aortic valve implantation (TAVI) and / or transcatheter aortic valve replacement (TAVR). For example, in the TAVI procedure, a physician may anchor the valve anchor of the heart valve prosthesis to the aortic valve annulus to guide the placement of the prosthetic leaflet structure. The valve prosthesis may comprise prosthetic leaflets, a valve anchor, a valve frame component, and a constriction component, which allows the valve anchor and frame component to be placed in series in a placement device. Petition 870250101744, dated 06 / 11 / 2025, p. 9 / 124 4 / 78 tion, in order to reduce the overall crossing profile of the placement device. According to some embodiments, the valve anchor may be coupled to one or more clamping mechanisms of a placement device. The clamping mechanism may be configured to include one of a variety of unique structures described in this document that securely engage with a portion of the valve anchor and allow reliable release of the valve anchor from it.

[0010] Additional embodiments of these devices and methods, and the like, will be evident from the following description, drawings, examples, and claims. As can be appreciated from the preceding and following description, each feature described in this document and each combination of two or more of these features is included within the scope of the present invention, provided that the features included in such a combination are not mutually inconsistent. Furthermore, any feature or combination of features may be specifically excluded or omitted from any embodiment of the present invention. Additional aspects and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying examples and drawings.

[0011] Additional features and advantages of the technology in question will be set forth in the description below and will, in part, be evident from the description, or may be learned by practicing the technology in question. The advantages of the technology in question will be realized and achieved by the structure particularly indicated in the written description and embodiments thereof, as well as in the attached drawings.

[0012] Certain features of valve prostheses, placement devices, drive cables, other devices, systems and Petition 870250101744, dated 06 / 11 / 2025, page 10 / 124 5 / 78 methods that can be implemented with the valve prostheses, placement devices, actuation cables, other devices, systems, and methods discussed in the present invention, can implement features and / or be used in combination with other features of valve prostheses, placement devices, actuation cables, other devices, systems, and methods described, for example, in International Application No. PCT / US2019 / 012406, filed January 4, 2019, and in International Application No. PCT / US2019 / 012408, the entirety of each of which is incorporated herein by reference.

[0013] It should be understood that both the previous general description and the detailed description below are illustrative and explanatory and are intended to provide further explanation of the technology in question. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Several features of illustrative embodiments of the inventions are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not to limit, the inventions. The drawings contain the following figures:

[0015] Figure 1 illustrates the placement of a valve prosthesis using a valve placement device in a transfemoral retrograde approach, according to some modalities.

[0016] Figure 2 shows a valve prosthesis, according to some embodiments.

[0017] Figure 3 is a partial lateral cross-sectional view of the valve prosthesis of Figure 2 loaded into a valve placement device, according to some embodiments.

[0018] Figure 4 is a perspective view of the valve placement device of Figure 2 showing a clamping mechanism in engagement with a valve anchor and in an enlarged state, Petition 870250101744, dated 06 / 11 / 2025, p. 11 / 124 6 / 78 according to some modalities.

[0019] Figure 5A is an enlarged perspective view of the valve placement device of Figure 3, showing the clamping mechanism for engaging the valve anchor, according to some embodiments.

[0020] Figure 5B is an enlarged perspective view of the valve placement device of Figure 3, showing a tubular member of the clamping mechanism in dashed lines to illustrate internal components of the clamping mechanism, according to some embodiments.

[0021] Figures 6A and 6B are a cross-sectional view of the valve placement device of Figure 5A, according to some embodiments.

[0022] Figures 7A-7D illustrate a process for disengaging the valve placement device of Figure 5A, according to some embodiments.

[0023] Figure 8 illustrates an alternative clamping mechanism in an engaged state, according to some embodiments.

[0024] Figure 9 illustrates another clamping mechanism, in an engaged state, according to some embodiments.

[0025] Figure 10 illustrates yet another tightening mechanism, in an engaged state, according to some embodiments.

[0026] Figure 11 illustrates yet another tightening mechanism, according to some modalities.

[0027] Figures 12A-12E illustrate yet another tightening mechanism and the process of disengaging it, according to some embodiments.

[0028] Figure 13 illustrates yet another clamping mechanism in a disengaged state, according to some embodiments.

[0029] Figure 14 illustrates yet another tightening mechanism in a Petition 870250101744, dated 06 / 11 / 2025, p. 12 / 124 7 / 78 engaged state, according to some modalities.

[0030] Figures 15A and 15B illustrate yet another tightening mechanism and the process of disengaging it, according to some modalities.

[0031] Figures 16A and 16B illustrate yet another tightening mechanism and the process of disengaging it, according to some modalities.

[0032] Figure 17 illustrates yet another tightening mechanism and the process of disengaging it, according to some modalities. DETAILED DESCRIPTION

[0033] In the detailed description that follows, numerous specific details are set forth to provide a complete understanding of the technology in question. It should be understood that the technology in question can be practiced without some of these specific details. In other cases, well-known structures and techniques have not been shown in detail so as not to obscure the technology in question.

[0034] Furthermore, although the present invention sets forth specific details of various embodiments, it is appreciated that the description is merely illustrative and should not be interpreted in any way as limiting. Additionally, it is contemplated that, although particular embodiments of the present invention may be described or shown in the context of aortic valve prostheses, such embodiments may be used in other cardiac valve prosthesis applications. Furthermore, various applications of such embodiments and modifications thereof, which may occur to those skilled in the art, are also encompassed by the general concepts described in this document.

[0035] Several modalities will now be described in more detail. Petition 870250101744, dated 06 / 11 / 2025, page 13 / 124 8 / 78 hereafter. Such embodiments may, however, be incorporated in many different forms and should not be interpreted as limited to the embodiments set forth in this document; rather, these embodiments are provided in such a way that this invention is complete and fully conveys its scope to those skilled in the art. Thus, one or more features shown or otherwise described in an embodiment in this document may be used or incorporated interchangeably in another embodiment that may not expressly show or disclose such features. Furthermore, one or more features shown or described for an embodiment in this document may be excluded from such embodiment unless expressly indicated using the technique.

[0036] As with all heart valves, a healthy aortic valve will open to allow blood flow and close to prevent blood backflow. However, valve disease and dysfunction can result in regurgitation or decreased blood flow (stenosis). In these cases, a replacement aortic valve prosthesis must be used to perform the functions of a healthy aortic valve.

[0037] Minimally invasive surgical techniques are evolving, where a valve prosthesis can be introduced into a patient using a catheter that is inserted through a small incision providing access, for example, to a femoral artery or directly to the heart. These implantation techniques have shown promising results in providing treatment options for patients who are unsatisfactory candidates for open surgery. However, challenges still remain in such catheter-based prosthetic valve placement.

[0038] For example, according to one aspect of at least one modality described in this document is the perception that the Petition 870250101744, dated 06 / 11 / 2025, p. 14 / 124 9 / 78 The advancement of a conventional tubular placement device through a vessel exerts tension against the vessel walls and carries the risk of damaging the vessel walls. Furthermore, according to one aspect of at least one modality described in this document is the perception that transcatheter prosthetic valves may not be able to treat patients with aortic regurgitation. Additionally, according to one aspect of at least one modality described in this document is the perception that conventional prosthetic valves may be difficult to position, may require rapid ventricular rhythm, and may have limited expansion. Consequently, the implantation and use of conventional prosthetic valves may result in complications such as vascular damage, moderate to severe paravalvular leak, valve thrombosis / migration, coronary artery blockage, and excessive stress due to excessive radial force.

[0039] The present invention describes various aspects of heart valve prostheses that can be placed on a defective heart valve in a patient. The valve prostheses may comprise at least one valve anchor, which is movably connected, movably attached, flexibly connected, displaceably connected, attached or coupled to a radially expandable valve support or frame. The valve frame may comprise prosthetic valve leaflets or cusps and provide the functionality of the native heart valve. Certain features of valve prostheses, which can be implemented with the prostheses discussed in the present invention, are also further described, for example, in U.S. Patent No. 8,366,768, the entirety of which is incorporated herein by reference.

[0040] Thus, the present invention provides a variety of features that can be optionally incorporated into or excluded from any of the embodiments explicitly discussed or illustrated. Petition 870250101744, dated 06 / 11 / 2025, p. 15 / 124 10 / 78 described in this document. These modifications and combinations of features can be performed by a person skilled in the art to achieve the advantages and benefits discussed in this document. Furthermore, certain modifications or combinations are indicated or suggested in this document, but it is contemplated that a person skilled in the art may implement or exclude certain aspects or features described in this document in the development of a suitable modality or implementation of these teachings. Advantageously, several modalities described in this document allow for the treatment of patients with aortic regurgitation, permit precise axial, angular, and radial positioning of the valve prosthesis, minimize valve migration and paravalvular leakage, avoid damage to the valve annulus, minimize the need for a pacemaker, and decrease the likelihood of coronary artery blockage.

[0041] Some of these features and benefits of a heart valve prosthesis and a placement system thereof are illustrated in relation to Figures 1-4. Figure 1 illustrates the use of the placement device in a human heart 10. The heart 10 may comprise an aorta 12 having an aortic arch 14 and an aortic valve 16. The aortic valve 16 may comprise a plurality of native valve leaflets 18 and separate the aorta 12 from the left ventricle 20. According to some embodiments, a physician may operate a cable actuator 50 to control the placement and release of a valve prosthesis 100. The valve prosthesis 100 may be carried by a placement device to be advanced retrogradely through the aorta 12 until it reaches and is positioned through the native valve leaflets 18 of the aortic valve 16.

[0042] With reference to Figures 1 and 2, during placement of the valve prosthesis 100 to the native valve site, a support frame 102 and a valve anchor 104 of the prosthesis 100 can be po Petition 870250101744, dated 06 / 11 / 2025, p. 16 / 124 11 / 78 sectioned in tandem, as an axially displaced unit (with or without partial or complete overlap between the anchor and the frame) along the longitudinal axis of the placement device 200. This configuration, as opposed to a concentric arrangement, can allow for a more radially compact configuration of the valve prosthesis components 100, creating a much smaller cross-section and facilitating catheter-based placement. This can improve the flexibility of the placement device 200, allowing the placement device 200 to be advanced over a guidewire through the tortuous geometries of the circulatory system and, in particular, the aortic arch 14. In fact, even with guidewire-guided placement devices, the aortic arch 14 presents a difficult obstacle due to its sudden and high degree of curvature. Often, this is a limiting restriction for some surgeries or placement devices.However, according to the various benefits and advantages of some modalities described in this document, as illustrated in Figure 1, the placement device 200 can be advanced over the aortic arch 14 to a target location in the aortic valve region 16.

[0043] As shown in Figure 1, once the valve anchor 104 is in the desired position, the support frame 102 can be released from the distal carrier assembly and expanded into apposition with the native valve leaflets 18 and the inner aspects of the valve anchor 104, thus sandwiching the native valve leaflets 18 between the support frame 102 and the valve anchor 104. Advantageously, by sandwiching the native valve leaflets 18 between the support frame and the valve anchor, the valve prosthesis 100 can have a reduced dependence on radial force retention. Furthermore, by sandwiching the native valve leaflets 18 between the support frame and the valve anchor, the likelihood of the native valve leaflets 18 blocking the coronary artery opening is reduced, the Petition 870250101744, dated 06 / 11 / 2025, p. 17 / 124 12 / 78 which may be beneficial for patients with low coronary ostia distance and in patients with an existing valve prosthesis who may need a new valve prosthesis within the existing valve prosthesis (valve-in-valve application). The support frame and valve anchor can thus expand in contact with the aortic valve 16, exerting a chronic external force against the native valve leaflets 18 and the aortic valve annulus 22. Subsequently, the prosthetic valve leaflets of the prosthesis 100 can begin to function in the desired manner and provide the same operation as a native valve.

[0044] According to some embodiments, the present invention also provides a cable actuator that can be used to control the operation of the placement device presently described and allow a physician to reliably and accurately control the placement of the valve prosthesis. Figure 1 illustrates features and operation of the cable actuator 50 which can, according to some embodiments, be operated to place the valve prosthesis.

[0045] Figure 1 illustrates the cable actuator 50, which can control one or more functions of a placement device (e.g., the placement device 200 discussed in this document) for placement of a valve prosthesis (e.g., the cardiac valve prosthesis 100 discussed in this document). The cable actuator 50 may comprise a plurality of actuators or moving elements, such as handles or buttons. The moving elements may allow a physician to control one or more operations of the placement device 200. The cable actuator 50 may comprise a control cable 52 having a longitudinal axis 54. The cable actuator 50 may also be referred to as a control unit. In some embodiments, the cable actuator 50 may be coupled to a second core member (shown, for example, in Figure 3). The control cable 52 Petition 870250101744, dated 06 / 11 / 2025, p. 18 / 124 13 / 78 can support the actuators and be held by the physician during the procedure.

[0046] In some embodiments, as illustrated in Figure 1, the cable actuator 50 may comprise a first moving element 56, a second moving element 58, a third moving element 60, and a fourth moving element 62. The first moving element 56 may be used to drive the placement device 200, the second moving element 58 may be used to release the valve anchor, the third moving element 60 may be used to release the nose cone or valve frame, and the fourth moving element 62 may be used as a nose cone toggle latch. The first moving element 56, the second moving element 58, the third moving element 60, and the fourth moving 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.

[0047] Optionally, in some embodiments, one or more of the moving elements, such as the second moving element 58 and / or the third moving element 60, may include a safety button or sliding switch 64 that prevents unintentional rotation of the moving elements. The safety switch 64 may be configured as a resilient button or sliding mechanisms that can be actuated to release a latch that provides resistance to rotational or translational movement of the respective moving element. In some embodiments, the moving elements may have a raised feature that provides a visual and tactile indication of the rotational position so that the user does not need to look at the device to operate it, which may facilitate tactile engagement and actuation by the physician. Other features of the cable actuator 50 and methods for operating the cable actuator 50 are discussed and illustrated in U.S. Patents Nos. Petition 870250101744, dated 06 / 11 / 2025, page 19 / 124 14 / 78 11,090,156 and 11,083,577, the entirety of which is incorporated herein by reference.

[0048] Referring now to Figure 2, a valve prosthesis 100 and its components are shown in various configurations. The valve prosthesis 100 may be delivered to a patient using a suitable placement device, including embodiments of the placement devices described in this document. The valve prosthesis 100 may comprise a support frame 102 and a valve anchor 104 to which the support frame 102 is movably connected, movably attached, flexibly connected, displaceably connected, bonded or coupled.

[0049] The valve prosthesis 100 can be configured so that the valve prosthesis 100 components are advanced in series while still being movably connected, movably fixed, flexibly connected, displaceably connected, linked, or coupled to each other, thus minimizing a through-profile or cross-section of the placement system. The interconnection of valve prosthesis 100 components can allow different degrees of movement and can be set in an engaged or retained position that provides a limited range of movement. In some embodiments, the engaged position can also provide a predefined relative positioning of the valve prosthesis 100 components to facilitate proper placement and release of the valve prosthesis 100.Additionally, some modalities can provide a physician with a high degree of control and enhance the maneuverability of the valve prosthesis 100 when implanting the valve prosthesis 100 at the target location.

[0050] In some embodiments, the valve anchor 104 can be coupled to the support frame 102 when the support frame 102 is in the compact configuration prior to placement and expansion. Petition 870250101744, dated 06 / 11 / 2025, p. 20 / 124 15 / 78 In some embodiments, the valve anchor 104 is not fixed to the support frame 102. Furthermore, the valve anchor 104 may be separate from the support frame 102 or formed separately and subsequently coupled to the support frame 102. Thus, although at least a portion of the valve anchor 104, for example, the anchor leg, may be in contact with or otherwise reversibly fixed or connected to the support frame 102, no part of the valve anchor 104 is fixed, for example, welded or otherwise irreversibly adhered, to the support frame 102. Alternatively stated, the valve anchor 104, which may be in contact with or otherwise reversibly fixed to the support frame 102, is not irreversibly fixed to the support frame 102.

[0051] Furthermore, upon reaching the target site, the valve anchor 104 can be movably coupled to the support frame 102 in a manner that prevents the entire valve anchor 104 from being radially displaced from the support frame 102 when the valve anchor 104 is initially expanded. For example, portions of the valve anchor 104 may be radially displaced from the support frame during the initial landing of the valve anchor 104 against the native valve structure at the target site. In some embodiments, the support frame 102 may be implanted or expanded within the native heart valve structure, and the valve anchor 104 may become wedged between the support frame and the native valve tissue, becoming at least partially and possibly totally immobilized. The valve anchor 104 may function to hold the expanded support frame 102 in place within the native valve structure.

[0052] Optionally, the support frame 102 may be referred to as a valve frame or valve support frame. A Petition 870250101744, dated 06 / 11 / 2025, p. 21 / 124 16 / 78 Figure 2 illustrates the support frame 102 aligned and expanded within the valve anchor 104, in a configuration that is achieved when the prosthesis 100 is released and expanded within the native valve structure. The native valve structure includes the tubular valve ring or leaflets. This expanded configuration serves to secure the valve prosthesis 100 within the tubular ring of the native valve, engaging the native valve structure. In some embodiments, the expanded configuration of the valve prosthesis 100 can reduce the reliance on securing the valve prosthesis 100 with radial force exerted by the support frame 102 and the valve anchor 104 by squeezing or compressing the native valve leaflets between the support frame 102 and the valve anchor 104 of the valve prosthesis 100.Furthermore, as discussed later in this document, during the implantation of the valve prosthesis 100, the support frame 102 and the valve anchor 104 can be movable relative to each other in expanded and / or compressed states in order to facilitate proper positioning of the prosthesis 100 relative to the native valve ring and surrounding structures. In fact, several advantages afforded by the prosthesis placement device 100 described in this document allow a physician to achieve a higher degree of precision in the placement of the prosthesis 100, as well as making such increased precision easier to achieve.

[0053] Referring to Figure 2, the support frame 102 may comprise an outer surface and define a central orifice on a longitudinal axis 120. The longitudinal axis 120 corresponds to an inlet-outlet axis of the prosthesis 100. In some embodiments, the valve prosthesis 100 further comprises a plurality of leaflets or prosthetic valve cusps 106 that are coupled to the support frame 102. The support frame 102 may provide structural support for valve leaflets 106. Valve leaflets 106 po Petition 870250101744, dated 06 / 11 / 2025, p. 22 / 124 17 / 78 must have surfaces that define a reversibly sealable opening for unidirectional flow of a liquid through the prosthesis 100. The prosthesis 100 may include three valve leaflets 106 for a three-leaflet configuration. As appreciated, single-leaflet, double-leaflet and / or multi-leaflet configurations are also possible. For example, the valve leaflets may be coupled to the support frame 102 to encompass and control the flow of fluid through the lumen of the prosthesis 100. The prosthetic leaflets 106 may comprise one or more synthetic materials, manipulated biological tissues, biological valve leaflet tissues, pericardial tissues, reticulated pericardial tissues, aortic radicular tissue, chemically or biologically processed / treated tissue or combinations thereof. In some modalities, pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, human tissue, or combinations thereof.

[0054] Furthermore, in some embodiments, the valve prosthesis 100 may comprise a sealing component or membrane 108 that may be attached to an inner surface, an outer surface, and / or enclose the support frame 102, such as being laminated onto inner and outer surfaces of the support frame 102. 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 areas around the valve leaflets 106 so that blood flow occurs only between the valve leaflets 106 through the lumen of the prosthesis 100, as in a healthy native heart valve.

[0055] The support frame 102 and / or the valve anchor 104 may comprise a braided frame, a wire frame or a laser-cut frame (e.g., laser-cut tubular mesh), as shown in Figure 2. In some embodiments, the Petition 870250101744, dated 06 / 11 / 2025, p. 23 / 124 The support frame 102 and / or valve anchor 104 may comprise a shape-memory metal, which can change shape at a designated temperature or temperature range or by inducing stress. Alternatively, self-expanding frames may include those having a spring bias. The material from which the support frame 102 and / or valve anchor 104 are manufactured may allow the support frame 102 and / or valve anchor 104 to automatically expand to their functional size and shape when implanted, but also allow the support frame 102 and / or valve anchor 104 to be radially compressed to a smaller profile for placement through the patient's vasculature.Examples of suitable materials for self-expanding components described in this document (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, alginate, or combinations thereof. Shape-memory alloys having superelastic properties, generally made of nickel-titanium ratios, commonly known as nitinol, are preferred materials. In some embodiments, the self-expanding components described in this document may include materials including, but not limited to, shape-memory plastics, polymers, and thermoplastic materials that are inert in the body. In an alternative embodiment, the support frame 102 and / or the valve anchor 104 are not self-expanding and can be expanded, for example, using a balloon catheter, as is well known in the art.Examples of suitable materials for components described in this document include, but are not limited to, stainless steel and titanium. Optionally, the support frame 102 and / or the valve anchor 104 may comprise radiopaque materials to allow visualization under fluoroscopy or other techniques. Petition 870250101744, dated 06 / 11 / 2025, p. 24 / 124 19 / 78 image cas.

[0056] Optionally, the support frame 102 may comprise one or more hooks 109 that may engage with the native valve tubular ring tissue, the aortic root, or any other portion of the native valve when the support frame 102 is expanded within the native valve tubular ring. The hooks 109 may be hooked with the native valve tubular ring to secure the prosthesis 100 to mitigate any downstream or anterograde migration of the prosthesis 100 during the operation.

[0057] The support frame 102 may comprise a first end portion 110 and a second end portion 112. The first end portion 110 may be positioned upstream of the second end portion 112 when the prosthesis 100 is released within the tubular ring of the native valve. As illustrated in Figure 2, the first end portion 110 of the support frame 102 can be shaped as a generally flat end of a cylinder, where the first apices 114 of the support frame 102 are generally in a common plane, which can be oriented substantially perpendicular to a longitudinal axis 120 of the prosthesis 100. Furthermore, the second end portion 112 can be shaped to include a series of peaks 130 and valleys 132, where second apices or smaller peaks 136 of the support frame 102 collectively form the contours of the peaks 130 and valleys 132.The peaks 130 and valleys 132 of the second end portion 112 can be positioned downstream of the first end portion 110 when the prosthesis is seated within the tubular ring of the native valve.

[0058] According to some embodiments, the prosthetic leaflets 106 can be coupled in relation to the support frame 102 at locations circumferentially aligned with the peaks 130 of the second Petition 870250101744, dated 06 / 11 / 2025, page 25 / 124 20 / 78 of the end portion 112, as shown in Figure 2. In some embodiments, the prosthetic leaflets 106 can be coupled to the membrane 108, for example, using ultra-high molecular weight polyethylene sutures. This unique configuration can advantageously allow the prosthesis 100 to more completely approximate the native valve structures, permit more natural blood flow without limiting or restricting the movement of the valve leaflets 106, and integrate more seamlessly with the surrounding architecture of the heart. In some embodiments, the prosthetic leaflets 106 may comprise features including, but not limited to, flat features, flattened features, three-dimensional features, Bézier curves, or other suitable shapes. Optionally, the prosthetic leaflets 106 can be shaped by fixation in a leaflet-shaped mandrel.

[0059] The valve anchor 104 may comprise at least one U-shaped member, sinus locator, valve positioner, or valve suspensor 140 extending around a longitudinal axis of the valve anchor 104. As illustrated in Figure 2, the valve anchor 104 may comprise a plurality of U-shaped members 140, such as three U-shaped members 140, but may have fewer or more. In some embodiments, the U-shaped members 140 may be configured to engage with or fit within the posterior aortic sinus, left aortic sinus, and right aortic sinus of a native aortic valve. The U-shaped members 140 may each have a peak portion 142 and a base portion 144. The U-shaped members 140 may each comprise first and second legs 146, 148. The first and second legs 146, 148 of adjacent U-shaped members 140 may be interconnected at their peak portions 142.In addition, U-shaped members 140 may. Petition 870250101744, dated 06 / 11 / 2025, page 26 / 124 21 / 78 comprise different forms of a U-shape, such as a wave shape, V shape, W shape, or zigzag shape. Optionally, multiple valve anchors 104 may each comprise one or more U-shaped members 140, wherein the multiple valve anchors 104 engage cooperatively with the aortic sinus to anchor the valve prosthesis, as described in this document.

[0060] The valve prosthesis 100 may include a linking mechanism 160 that interconnects the support frame 102 to the valve anchor 104. The linking mechanism 160 may comprise a single continuous wire of material or multiple independent wires of material that interconnect the support frame 102 to the valve anchor 104. Furthermore, the linking mechanism 160 may attach in a sliding, engaged, or fixed manner to one or more locations on the support frame 102 and / or the valve anchor 104.

[0061] According to some embodiments, the valve anchor 104 may optionally define one or more engagement areas in one or more portions of the valve anchor 104, where a linkage mechanism 160 may engage with one or more engagement areas to restrict the relative movement between the support frame 102 and the valve anchor 104.

[0062] For example, in the interconnection of the respective peak portions, valve anchor 104 can define an engagement area 150. The engagement area 150 can also be referred to as a peak portion engagement area.

[0063] As illustrated in Figure 2, the support frame 102 can be flexibly coupled to the valve anchor 104 by means of one or more linking mechanisms 160. The linking mechanism 160 can be coupled to the support frame 102 and the valve anchor 104, allowing relative movement between the support frame 102 and the valve anchor 104. However, the linking mechanism Petition 870250101744, dated 06 / 11 / 2025, page 27 / 124 22 / 78 160 can be configured to limit the relative movement between the support frame 102 and the valve anchor 104. In some embodiments, the engagement area 150 of the valve anchor 104 can be used to further restrict the relative movement of the support frame 102 with respect to the valve anchor 104 when the linkage mechanism 160 is engaged in the engagement area 150, as discussed in this document.

[0064] The valve anchor 104 can thus be coupled to the support frame 102 to allow the valve anchor 104 to be moved axially or longitudinally relative to the support frame 102 while still remaining coupled to the support frame 102. This advantageous feature of some embodiments may allow a physician to independently position the valve anchor 104 relative to the support frame 102. For example, in a transcatheter aortic valve replacement, the physician may independently position the valve anchor 104 in order to adjust the base portions 144 of the valve anchor 104 in the aortic sinus. Portions of the aortic sinus may include the posterior aortic sinus, the left aortic sinus, and / or the right aortic sinus of a native aortic valve. In some modalities, the 104 valve anchor can rotate to be aligned with the respective aortic sinuses.In some embodiments, the interconnection of the valve anchor 104 with the support frame 102 may allow the valve anchor 104 to be rotated or repositioned so as to autorotate, to be aligned in or in relation to the aortic sinus. The longitudinal and rotational movement of the valve anchor 104 may be facilitated by interconnecting the engagement areas 150 of the valve anchor 104 with a controlled member or gripper of the placement device, as discussed further below.

[0065] With the valve anchor 104 landed in the respective aortic sinuses, the interconnection of the valve anchor 104 with the weapon Petition 870250101744, dated 06 / 11 / 2025, page 28 / 124 23 / 78 support frame 102 further allows the support frame 102 to be translated along the longitudinal axis 120 of the valve prosthesis 100. In some embodiments, during the placement procedure, 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 of these positions to a position in which the support frame 102 overlaps at least partially longitudinally or is concentric within the valve anchor 104. A range of various positions is illustrated, for example, in U.S. Patents Nos. 11,090,156 and 11,083,577, the entirety of which is incorporated herein by reference.

[0066] For example, when the support frame 102 is nested within the valve anchor 104, as shown in Figure 2, the base portions 144 of the valve anchor 104 may be spaced longitudinally from the first end portion 110 of the support frame 102 along the longitudinal axis 120 at a distance that is 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%, about 50% to about 75%, or about 60% to about 70% of a length of the support frame 102. In some embodiments, the support frame 102 may be contained within or otherwise completely overlapping the valve anchor 104. In some In some configurations, the support frame 102 may have minimal or no overlap with the valve anchor 104.The support frame 102 can move along the longitudinal axis 120 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. Petition 870250101744, dated 06 / 11 / 2025, p. 29 / 124 24 / 78 support frame 102. According to some embodiments, the U-shaped members 140 of the valve anchor 104 may be in nested positions within the aortic sinuses, and the base portions 144 of the valve anchor 104 may be approximately longitudinally adjacent, coplanar, or spaced from the first end portion 110 of the support frame 102. For example, the valve anchor 104 may be in a nested position when at least one base portion 144 of the valve anchor 104 is in contact with or adjacent to the basal attachments of the native aortic valve leaflets. Furthermore, the first end portion 110 of the support frame 102 may be longitudinally adjacent, coplanar, or spaced from the native valve structure (or a virtual ring formed by the basal attachments of the native aortic valve leaflets) or with the ventriculo-aortic junction.

[0067] The linking mechanism 160 can allow rotational and longitudinal movement of the valve anchor 104 relative to the support frame 102. Thus, despite the presence of the linking mechanism 160, the valve anchor 104 can move rotationally relative to the support frame 102. Furthermore, in some embodiments, the linking mechanism 160 can be fixedly attached or coupled to the support frame 102 and fixedly or slidingly attached to the valve anchor 104. When the support frame 102 is moved relative to the valve anchor 104, the linking mechanism 160 can slide along the U-shaped members 140. In some embodiments, the U-shaped members 140 generally have an arched or convex shape (as illustrated with the U-shaped members in Figure 2) that allows unrestricted movement of the linking mechanism 160 along the geometry of the first and second legs. 146, 148 of the U-shaped members 140.When the linkage mechanism 160 is held in sliding along the... Petition 870250101744, dated 06 / 11 / 2025, p. 30 / 124 25 / 78 first and second legs 146, 148 of the U-shaped limbs 140, the valve prosthesis 100 may be in a position referred to as a sliding state. In the sliding state, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 is variable and may be greater because the linkage mechanism 160 may move along the first and second legs 146, 148 of the U-shaped limbs 140.

[0068] In some embodiments, the linking 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 is moved relative to the valve anchor 104, the linking mechanism 160 may stretch, flex, deform elastically and / or plastically. As the linking mechanism 160 deforms, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 is variable, as permitted by the deformation of the linking mechanism 160.

[0069] Referring now to Figure 3, a side cross-sectional view of the valve prosthesis 100 loaded into the placement device 200 is provided, according to some embodiments. Among the many features illustrated in Figure 3, the placement device 200 may comprise a distal carrier assembly 206 that at least partially houses the support frame 102. Furthermore, Figure 3 shows that a proximal housing 210 of the placement device 200 may extend over the valve anchor 104 and the support frame 102. A distal housing 212 of the distal carrier assembly 206 may at least partially house at least the support frame 102. The proximal housing 210 may be coupled to a first core member 220, and the distal housing 212 may be coupled to a second core member 222. In some embodiments, the distal housing 212 may be coupled or connected to... Petition 870250101744, dated 06 / 11 / 2025, p. 31 / 124 26 / 78 threaded and / or adhesive form to the second core member 222.

[0070] Thus, according to some embodiments, in the compressed or placement configuration shown in Figure 3, the linkage 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 point of attachment of the linkage mechanism to the support frame 102 and the longitudinal extension of the proximal housing 210). Further details of placement devices and prostheses are provided in U.S. Patents Nos. 11,090,156 and 11,083,577, the entirety of which is incorporated herein by reference.

[0071] Furthermore, Figure 3 illustrates that the placement system can be used to engage the engagement areas 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 placement. As discussed in U.S. Patents Nos. 11,090,156 and 11,083,577, the entirety of each of which is incorporated herein by reference, this engagement can hold the engagement areas 150 in a common plane, generally oriented perpendicular to the longitudinal axis of the placement device 200.

[0072] In some embodiments, the placement device may comprise a clamping mechanism. The clamping mechanism may have one, two, three, four, or more clamping arms or other such components that serve as a point of contact with a respective point of contact of the valve prosthesis, such as the valve frame or valve anchor of the prosthesis. Thus, the clamping mechanism may be used to securely couple a portion of the valve anchor to the placement device to allow the physician to control the movement, operation, and implantation of the valve anchor. The mechanism Petition 870250101744, dated 06 / 11 / 2025, page 32 / 124 27 / 78 clamping can engage one or more portions or structures of the valve anchor using a variety of coupling mechanisms, which may use attachment means including mechanical engagement, dissolvable structures, chemically reactive degradable structures, electrolytically degradable structures and the like.

[0073] In some embodiments, when engaging the valve anchor, for example, in a base portion thereof, the grippers can precisely engage and control the longitudinal position of the valve anchor. Thus, the grippers can be used to control the articulation of the valve anchor as desired by the physician. For example, the grippers may each have independent translational actuation (e.g., relative to each other) which can collectively direct the valve anchor relative to or away from or toward a central or placement axis of the system. Additionally or optionally, the collective and / or individual actuation of the grippers can be used to indirectly or directly control or affect the position, shape and / or movement of the valve frame.

[0074] Figure 4 illustrates aspects of the placement device 200, according to some embodiments. These figures do not illustrate all components of the placement device that can be incorporated into an embodiment. However, the features illustrated in these figures can be incorporated into embodiments of the placement device to facilitate engagement with the valve anchor and / or facilitate placement and control of the valve anchor during deployment and release of the valve anchor at the target location.

[0075] For example, Figure 4 illustrates an embodiment of a placement device 200 comprising a clamping mechanism 202. The placement device 200 is shown with the valve anchor 104 in a partially open, but still restricted (partially deployed) configuration. In some embodiments, the mechanism Petition 870250101744, dated 06 / 11 / 2025, page 33 / 124 28 / 78 clamping device 202 may comprise at least one clamping arm. In some embodiments, the clamping arm may comprise a tubular housing or structure. As shown, the placement device 200 may have three clamping arms 224a, 224b, 224c that can engage and control the longitudinal position of the valve anchor 104.

[0076] In some embodiments, each clamping arm 224a, 224b, 224c of the placement device 200 may comprise a coupling wire that is movable within a lumen of a tubular housing. The valve anchor 104 may be configured to comprise an anchor tab extending from a coupling area 150a, 150b, 150c of the valve anchor 104.

[0077] In some embodiments, the coupling wire may interconnect with one or more portions of the valve prosthesis to provide a releasable connection with it.

[0078] For example, the coupling wire can be releasable attached to a hole, protrusion, or other structure of the valve anchor. The coupling wire can pass through or around a coupling area, such as an anchor tab, of the valve anchor and be released by physician actuation to allow separation of the valve prosthesis from the placement device.

[0079] In some embodiments, the engagement wire may comprise a distal end portion that includes pins, ridges, or protrusions that can be coupled to the engagement structure of the anchor tab in the valve anchor engagement area. When engaged, the engagement wire and anchor tab can be proximally pulled into the lumen of the tubular casing, which secures the engagement wire and anchor tab to each other in both radial and longitudinal directions. However, when the engagement wire and anchor tab are moved out of the lumen of the tubular casing, the engagement wire and anchor tab can be disengaged as per the valve anchor Petition 870250101744, dated 06 / 11 / 2025, page 34 / 124 29 / 78 and the anchor tab expand radially, thus disengaging the anchor tab from the engagement wire. Some aspects of the placement systems, prosthetic valves, and placement methods described in this document may be implemented in accordance with the features described in U.S. Patent Applicant Nos. 11,090,156 and 11,083,577, the entirety of which is incorporated herein by reference.

[0080] The wire may be constructed of a metallic or non-metallic material. In some embodiments, the valve anchor may comprise a surface-treated (passivated) nitinol. In such embodiments, it may be advantageous to have the wire made of a non-metallic material so as not to break the surface. As discussed in this document, the arrangement and position of the wire may allow the wire to maintain engagement with the valve anchor rather than requiring or relying on a high-friction engagement between the wire and the valve anchor. Thus, in some embodiments, the wire may comprise a non-metallic material with a low coefficient of friction against the valve anchor, thereby allowing the wire to move smoothly and freely upon intentional actuation by the physician, preventing unintentional movement of the wire.

[0081] Alternatively, the wire may comprise a metal, such as nitinol, which may be advantageous because nitinol is less prone to twisting and plastic deformation. However, steel or other materials may also be used.

[0082] In some modalities, the wire may have a diameter of about 0.020 over most of its length to provide stiffness, reduced elongation, and provide responsiveness to proximal actuation during release.

[0083] In some embodiments, the wire may be constructed of a nitinol grounding wire without a center at the distal end portion (e.g., a length of 30 to 50 mm of grounding wire) Petition 870250101744, dated 06 / 11 / 2025, page 35 / 124 30 / 78 to the distal end of a wire 0.020 to 0.008 in diameter; grinding may occur over a tapered transition). In some embodiments, the grounding wire may be the one that connects to the anchor tab.

[0084] The wire can be constructed as: a centerless grounding wire (continuous piece of material); a welded wire (e.g., connecting two wires of different diameter by means of a weld, such as a laser weld); a hypotube connected to a small wire in the center and another wire that is welded, brazed, or attached near a distal end portion of the hypotube (which can provide the advantage of the rigidity of the hypotube and the flexibility of the distal portion using a wire); a wire that is bent over itself with the two ends being offset (one of the end portions extends distally to allow engagement with the valve anchor).

[0085] According to some embodiments, the engagement between the placement device and the valve prosthesis, such as using the anchor tab, may allow a control limb or gripper to engage with the valve anchor for a transfemoral retrograde placement approach or for an anterograde placement approach (as shown in U.S. Patent No. 11,090,156 or U.S. Patent No. 11,083,577). For example, the anchor tab may receive a control limb or gripper that approaches the valve anchor proximal to the peak portions to allow the valve anchor to be used for a retrograde approach (e.g., a transfemoral retrograde approach) in valve anchor placement.In addition, the anchor retention component may receive the control member or gripper that approaches the valve anchor proximal to the first and second U-shaped members to allow the valve anchor to be used for an anterograde, apical, or transapical approach in valve anchor placement. Petition 870250101744, dated 06 / 11 / 2025, page 36 / 124 31 / 78

[0086] Various configurations of the anchor flap engagement areas of the valve anchor can be used in some embodiments described in this document. Furthermore, in any of the embodiments described in this document, the engagement area may comprise barbs or hooks over which a linking mechanism may pass, as discussed in U.S. Patent No. 11,083,577, the entirety of which is incorporated herein by reference. The barbs or hooks may allow unidirectional movement of the linking mechanism – once the linking mechanism crosses the barbs or hooks, the barbs or hooks will prevent reverse movement of the linking mechanism over the barbs or hooks. The illustrated embodiments provide double peaks or valleys that may tend to trap the linking mechanism during the prosthesis placement stages, as discussed in this document.When the linking mechanism is thus captured, the valve prosthesis 100 may be in a position referred to as a retained position.

[0087] During use, after the valve anchor has been released from within the proximal sheath and after the valve anchor and valve frame have been released from the placement device, the clamping mechanism of the placement device can be configured to be compactly reassembled and removed from the introducer sheath to minimize any damage to the blood vessel through which the placement device was advanced.

[0088] Referring now to Figures 5A-7D, a first embodiment of the engagement between a clamping mechanism 300 and a valve anchor 104 is shown in various views and in an engaged and a disengaged position. Figures 5A and 5B illustrate that the clamping mechanism 300 may comprise a tubular member 302 (a transparent component is shown in Figure 5B) and a coupling thread 304. Petition 870250101744, dated 06 / 11 / 2025, page 37 / 124 32 / 78

[0089] The coupling wire 304 may extend within a lumen 306 of the tubular member 302. The tubular member 302 may comprise one or more lateral openings or orifices 310 through which the coupling wire 304 may pass in order to form an interlocking coupling with the valve anchor 104. For example, in some embodiments, the coupling wire may extend within a proximal section of the tubular member and exit the lumen along a distal section thereof to facilitate coupling with a valve anchor.

[0090] As shown in the embodiment of Figures 5A-7D, the tubular member 302 may comprise a plurality, such as two, three, four, five or more, of openings that allow the coupling wire 304 to engage with the valve anchor 104. For example, the coupling wire 304 may exit and re-enter the lumen 306 to facilitate engagement with an anchor tab 152 of the valve anchor 104.

[0091] The anchor tab 152 can enter the lumen 306 of the tubular member 302 through an end opening 312 of the tubular member 302. When positioned therein, the anchor tab 152 can be engaged with the engagement wire 304. For example, as shown in Figures 5B-6B, the engagement wire 304 can pass through a slot or opening 170 of the anchor tab 152. In this configuration, the engagement wire 304 can hold the anchor tab 152 in an engaged position that ensures the clamping mechanism 300 is securely engaged with the valve anchor 104. However, upon actuation by the physician, the engagement wire 304 can be withdrawn proximally within the lumen 306 of the tubular member 302. As the engagement wire 304 is withdrawn proximally, an end portion 320 of the wire The coupling wire 304 will be pulled through the openings 310 of the tubular member 302 until the end portion 320 of the coupling wire 304 is also pulled through the slot 170 of the anchor tab 152.This process of gradual release or disengagement is illustrated. Petition 870250101744, dated 06 / 11 / 2025, p. 38 / 124 33 / 78 in Figures 7A and 7B. By continuously withdrawing the proximal attachment wire 304 through the lumen 306, the attachment wire 304 can be pulled back into the lumen 306 of the tubular member 302 and the anchor tab 152 will be disengaged from the attachment wire 304.

[0092] The 310 openings may comprise one or more proximally positioned openings and / or one or more distally positioned openings. Several embodiments are illustrated in Figures 5A10 that utilize such openings which may allow access to a lumen of the tubular member to facilitate engagement with the valve anchor.

[0093] For example, Figures 5A-7D illustrate an embodiment in which the openings are arranged as seen in Figure 6B, with the first and second distal openings 310a, 310b and the first and second proximal openings 310c, 310d. In some embodiments, the first distal opening 310a may be diametrically opposite the second distal opening 310b. In some embodiments, the first proximal opening 310c may be diametrically opposite the second proximal opening 310d. However, the first proximal opening 310c may be longitudinally displaced from the second proximal opening 310d.

[0094] In order to engage the valve anchor, the engagement wire may extend through one or both of the most distal pair of openings 310a, 310b and / or one or both of the most distal pair of openings 310a, 310b and engage with the valve anchor in the engagement area, as discussed in this document.

[0095] In some embodiments, the end portion 320 of the hitch wire 304 may be threaded into the first proximal opening 310c, as shown in Figure 6B. As such, this arrangement may be useful to help prevent the end portion 320 from inadvertently extending into another of the openings 310a, 310b, or 310d (or Petition 870250101744, dated 06 / 11 / 2025, p. 39 / 124 34 / 78 others).

[0096] However, in some embodiments, it may be advantageous to have the final opening (i.e., the opening through which the end portion 320 of the engagement wire 304 passes when entering the lumen 306) being the second proximal opening 310d. Thus, the arrangement in Figure 6B can be reversed so that the wire 304 initially exits the lumen 306 through the first proximal opening 310c, then re-enters the lumen 306 through the second distal opening 310b to engage with the slot 170, then exits the lumen 306 through the first distal opening 310a and finally re-enters the lumen 306 through the second proximal opening 310d. In this arrangement, positioning the 304 wire through these openings can thus allow for a shorter or faster positional release time of the 320 end portion of the 304 wire from the second proximal opening 310d.

[0097] According to some embodiments, opening 310 may have a longitudinal axis that extends substantially perpendicular to a longitudinal axis of the tubular member. For example, as shown in Figure 6B, the first and second distal openings 310a, 310b may each have a longitudinal axis that extends substantially perpendicular to a longitudinal axis of the tubular member.

[0098] Alternatively, however, in some embodiments, as shown by the first and second proximal openings 310c, 310d of Figure 6B, the openings 310 may have a longitudinal axis that extends transversely relative to a longitudinal axis of the tubular member. As shown in Figure 6B, the first and second proximal openings 310c, 310d may have a longitudinal axis that extends transversely relative to a longitudinal axis of the tubular member. This transverse alignment of the longitudinal axis may facilitate the movement of wire 304 through the opening. Petition 870250101744, dated 06 / 11 / 2025, page 40 / 124 35 / 78

[0099] According to some embodiments, the arrangement of multiple openings may allow wire 304 to be oriented transversely or perpendicularly to the direction of flap travel when pulled out of lumen 306. The embodiments shown may allow the wire to remain statically positioned and retain or engage the flap, even if the end portion of the wire is inadvertently dislodged from the end opening.

[00100] Subsequently, as shown in Figures 7C and 7D, the valve anchor can begin to be separated from the clamping mechanism 300 so that the anchor tab 152 is fully removed from the lumen 306 of the tubular member 302. Once the anchor tab 152 has been removed from the lumen 306 of the tubular member 302, the valve anchor 104 can expand radially freely relative to the placement device 200 (not shown).

[00101] Among the many advantages associated with the embodiment illustrated in Figures 5A-7D is the secure engagement between the clamping mechanism and the valve anchor 104, also allowing for easy disengagement. Secure engagement can be achieved according to the new embodiments described in this document, given the increased ability to have precise tolerances between an adjusted length of the anchor tab within the lumen (e.g., from the engagement area of ​​the valve anchor to a distal end edge of the anchor tab slot) and a length 324 of the tubular member openings from the end opening thereof, which can be combined to provide precise alignment of the slot with the openings and minimize noise when the anchor tab is inserted into the lumen and engaged by the engagement wire.

[00102] For example, in some embodiments, a more distal set of 330 apertures, as illustrated in Figures 6A-7B, may be positioned in a substantially equal longitudinal position. Petition 870250101744, dated 06 / 11 / 2025, p. 41 / 124 36 / 78 along the axis of the tubular member 302 so that the most proximal edges of the slot 170 and the most distal set of openings 330 are positioned adjacent to each other or in a substantially common longitudinal position along the axis of the tubular member 302. This relative positioning of the most proximal edges of the slot 170 and the most distal set of openings 30 can ensure that when the anchor flap 152 is fully inserted into the end opening 312, the positions of these edges can be aligned and engaged against the engagement wire 304 to limit distal migration of the anchor flap 152 out of the lumen 306 of the tubular member 302.Therefore, by aligning and positioning the most distal set of openings 330 and the slot 170 of the anchor tab 152, the base portion 144 of the valve anchor 104 can firmly abut and be retained against the distal end of the tubular member 302 until the engagement wire 304 is proximally withdrawn into the lumen 306, thus releasing the valve anchor 104 from engagement with the tightening mechanism 300.

[00103] These and other features described in this document provide an innovative design that allows a physician to take advantage of the benefits of secure valve anchor engagement until valve anchor release is required and the assurance that the valve anchor will be released without causing damage to the valve anchor or native valve structure (e.g., requiring a twisting, pulling, or bending force or other damaging movement) that may inadvertently occur during valve anchor release.

[00104] Furthermore, according to at least some of the methods described in this document, there is a perception that these challenges have not been resolved despite years of research and development by numerous companies at great cost. The present Applicant, through the methods described and suggested in this document, has been able to al Petition 870250101744, dated 06 / 11 / 2025, page 42 / 124 37 / 78 successfully achieve a solution that minimizes or successfully prevents inadvertent release of the valve anchor or cardiac prosthesis during placement and ensures that the cardiac valve prosthesis can be precisely released at the target location to avoid any trauma or misalignment of the valve prosthesis during placement.

[00105] Referring now to Figure 8, another embodiment of a clamping mechanism is illustrated. Similar to the embodiment shown in Figures 5A-7D, the embodiment illustrated in Figure 8 may also comprise a tubular member having a plurality of openings and a coupling wire that can pass through the openings and engage with a portion of a valve anchor.

[00106] As illustrated in Figure 8, a clamping mechanism 400 may comprise a tubular member 402 (shown as a transparent component) and a wire coupling mechanism 404 that may extend at least partially within a lumen 406 of the tubular member 402. Although the clamping mechanism 400 may share many of the same operating principles and characteristics as the clamping mechanism 300 discussed above, the wire coupling mechanism 404 provides a simpler alternative structure and function. Therefore, the discussion of the characteristics and advantages of the clamping mechanism 300, which may also apply to the clamping mechanism 400, will not be repeated in this document for brevity.

[00107] With regard to the 404 engagement wire mechanism, 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 discrete steps in the release process.

[00108] For example, the engagement wire mechanism 404 may comprise a pull wire 410 and a loop wire 412. The pull wire 410 and the loop wire 412 may cross and engage with each other. Petition 870250101744, dated 06 / 11 / 2025, page 43 / 124 38 / 78 at a distal location (e.g., adjacent to the fitting area along the valve anchor is engaged with the clamping mechanism) along the clamping mechanism 400. As illustrated, the pull wire 410 and the loop wire 412 can cross and create a closed loop or by the engagement wire mechanism 404 engages with a slot 170 of the valve anchor 104.

[00109] Therefore, similar to the embodiment discussed above in relation to the clamping mechanism 300, an anchor tab 152 of the valve anchor 104 can be inserted into an end opening 420 of the tubular member 402 and the traction wire 410 and / or the loop wire 412 can pass through the slot 170 of the anchor tab 152 to restrict the axial movement of the anchor tab 152 out of the opening 420 until the engagement wire mechanism 404 is disengaged by the physician, thus allowing the clamping mechanism 400 to disengage from the valve anchor 104.

[00110] According to some embodiments, the loop wire 412 may comprise an engagement structure, such as an opening structure 430 that extends through or is coupled to the loop wire 412. As illustrated, the loop wire 412 may be configured to incorporate or be coupled to the opening structure 430 along a distal end portion of the loop wire 412. The opening structure 430 may be configured to receive the pull wire 410 through it, thus forming a loop that may engage with the slot 170 of the valve anchor 104.

[00111] In order to disengage the engagement wire mechanism 404 from the slot 170, the physician can approximately retract the traction wire 410, which will cause the traction wire 410 to eventually separate and be removed from the opening structure 430 to separate the traction wire 410 from the loop wire 412. Once separated, the loop wire 412 can be approximately retracted into the lumen 406 and exit the slot 170. In operation, Petition 870250101744, dated 06 / 11 / 2025, page 44 / 124 39 / 78 Both the pull wire 410 and the handle wire 412 can be approximately retracted and positioned entirely within the lumen 406 after disengaging the valve anchor 104. Furthermore, the anchor tab 152 can extend from the end opening 420 in order to allow the valve anchor 104 to expand freely at the target location.

[00112] According to at least some embodiments described in this document, it is perceived that the clamping mechanism 400 may allow the physician to operate separate controls or actuators that control the movement of the pull wire 410 and the loop wire 412, thus establishing discrete steps of disengaging the pull wire 410 from the loop wire 412 and subsequently allowing the physician to conduct a final disengagement of the loop wire 412 from the slot 170. These actions may be performed by rotating or translating an actuator or handle of the placement device's control cable. This discrete step of disengaging the pull wire 410 from the loop wire 412 may offer additional certainty and control to the physician, thus minimizing any inadvertent disengagement or minimizing ambiguity about when or if the disengagement process has begun. This may be advantageous during the placement procedure, so that a physician receives another discrete step in the disengagement process.

[00113] Additionally, some embodiments of the clamping mechanism 400 can be implemented such that the traction wire 410 comprises a distal end portion 440 that extends beyond the opening structure 430 to a position adjacent to the end opening 420, or within about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm of the end opening 420. The dimensions and configuration of the distal end portion 440 may depend on the axial length of the slot 170, the position of the site opening 442 of the tubular member 402, and the gauge of the traction wire 410. In fact, according to some embodiments, the Petition 870250101744, dated 06 / 11 / 2025, p. 45 / 124 40 / 78 tension wire 410 will provide sufficient rigidity and will be able to withstand any lateral bending force exerted on it by the handle wire 412 so that tension wire 410 is not pulled through the slot 170 and disengaged from the handle wire 412 inadvertently.

[00114] Furthermore, according to some embodiments, the opening structure 430 may have an internal profile or dimension that corresponds to an external profile or dimension of the pull wire 410. According to some embodiments, the external cross-section or profile of the pull wire 412 and the opening structure 430 may be smaller than a corresponding dimension or profile of the slot 170, in order to allow the pull wire 412 to be pulled through the slot 170.

[00115] For example, according to some embodiments, the opening structure 430 may have an expanded configuration when the pull wire 410 is inserted through it (the expanded configuration of which may be larger than the corresponding dimension or profile of the slot 170), thus preventing the opening structure 430 from passing through the slot 170 in the expanded configuration. However, after the pull wire 410 is removed from the opening structure 430, the opening structure 430 may be compressed or automatically return to a retracted configuration that is able to pass through the slot 170. Consequently, the configuration of the opening structure 430 may facilitate the engagement or disengagement of the engagement wire mechanism 404 with the anchor flap 152.

[00116] Referring now to Figure 9, a further embodiment of a clamping mechanism 450 is illustrated. The clamping mechanism 450 may comprise a tubular member 452 and a coupling wire 454. Similar to the embodiment discussed above in relation to Figures 5A-7D, the coupling wire 454 may comprise a single continuous wire that passes through a lumen 456 of the tubular member 452 and through openings 460 of the tubular member in order to form a loop. Petition 870250101744, dated 06 / 11 / 2025, p. 46 / 124 41 / 78 engaging with a portion of a valve anchor 104. According to some embodiments, the clamping mechanism 450 may be configured such that the tubular member 452 comprises a slot or recess 462 along an outer surface of the tubular member 452. The slot or recess 462 may comprise or form a receptacle 464 having one or more structures that are formed to be complementary to a form or structure of the valve anchor 104 and / or the anchor tab 152.

[00117] For example, the receptacle 464 shown in Figure 9 may comprise a raised area 466 configured to receive the valve anchor 104 therein and to restrict the longitudinal or axial movement of the valve anchor 104 relative to the tubular member 452. For example, the raised area 466 may comprise a depression or pit that allows the valve anchor 104 to be positioned therein and that restricts the degrees of freedom of movement of the valve anchor 104, except for a degree of radial translational movement that is generally perpendicular to a longitudinal axis 470 of the tubular member 452. Therefore, unless otherwise restricted, the valve anchor 104 may exit the raised area or receptacle 464 in a direction radially away from the longitudinal axis 470, but would otherwise be restricted against movement in other directions (translational or rotational).

[00118] In some embodiments, the engagement wire 454 can restrict the radial movement of the valve anchor 104 and thus provide safety engagement between the valve anchor 104 and the clamping mechanism 450. For example, the engagement wire 454 can rotate around the anchor tab 152 and in the slot 170 of the anchor tab 152, thus engaging the anchor tab 152 and the valve anchor 104 to restrict the radial movement of the valve anchor in a direction away from the longitudinal axis 470 and out of engagement with the raised area 466. Petition 870250101744, dated 06 / 11 / 2025, page 47 / 124 42 / 78

[00119] Optionally, the tubular member 452 can be configured so that the receptacle 464 comprises opposing rail portions 472 that extend longitudinally away from the protrusion area 466 and define a gap between them that is configured to receive at least one portion of the valve anchor (e.g., the anchor flap 152) therein. The rail portions 472 can thus assist in restricting degrees of movement of the anchor flap 152 and the valve anchor 104 relative to the tubular member 452.

[00120] Among the advantages associated with the 450 clamping mechanism embodiment illustrated in Figure 9 is the increased ease of disengaging and separating the valve anchor 104 from the tubular member 452. For example, the placement device can be configured so that the receptacles 464 of the 450 clamping mechanism (especially when multiple 450 clamping mechanisms are used, as in the placement device embodiment shown in Figure 4, i.e., when three clamping mechanisms are used), the receptacle 464 can be radially outward relative to a longitudinal axis of the placement device. Consequently, when the receptacle 464 is radially outward or open in a direction away from the longitudinal axis of the placement device, the valve anchor 104 can expand in a direction radially away from the 450 clamping mechanism with ease.In this way, once the coupling wire 454 is removed proximally by the physician and disengaged from the slot 170, the valve anchor 104 can immediately release from the tubular member 452 and expand in apposition to the native tissue of the target area. Thus, the clamping mechanism 450 will not tend to interfere with the expansion of the valve anchor 104.

[00121] Referring now to the embodiment illustrated in Figure 10, similar to the embodiment illustrated in Figure 9, a clamping mechanism 480 may comprise a tubular member 482 and a wire Petition 870250101744, dated 06 / 11 / 2025, p. 48 / 124 43 / 78 gate 484 which can collectively engage a valve anchor 104. Similar to clamping mechanism 450, clamping mechanism 480 may comprise a receptacle 486 configured to receive at least a portion of the valve anchor 104, such as the anchor tab 152, and to restrict degrees of movement of the valve anchor 104 relative to the tubular member 482. Several features and functions of the tubular member 482 and receptacle 486 are similar to those discussed above in relation to the tubular member 452 and receptacle 464 shown in Figure 9 and will not be repeated in this document for brevity, but are incorporated by reference.

[00122] In contrast to the clamping mechanism 450 embodiment shown in Figure 9, the clamping mechanism 480 can be configured such that the coupling wire 484 comprises a distal end segment 488 that is removablely coupled to an end cap 490 disposed at a distal end of the tubular member 482. The distal end segment 488 of the coupling wire 484 can be attached to the end cap 490. This attachment can be by means of an adhesive or mechanical means. In some embodiments, the end cap 490 can be formed on the distal end segment 488 of the coupling wire 484 prior to the assembly of the clamping mechanism 480 and the valve anchor 104.Furthermore, the end cap 490 can be detached and attached to a distal portion 492 of the tubular member 482 so that when the coupling wire 484 is pulled proximally and detached from the end cap 490, the end cap 490 remains attached to the distal portion 492 of the tubular member 482.

[00123] 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 coupled together during the assembly of the placement device with the valve prosthesis. Petition 870250101744, dated 06 / 11 / 2025, page 49 / 124 44 / 78 part. 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 that is configured to receive the distal end segment 488 of the coupling wire 484. In some embodiments, the distal end segment 488 may be positioned within the cavity 494 with or without an adhesive that secures the coupling wire 484 to the inner surface of the cavity 494. Consequently, with sufficient rigidity, the coupling wire 484 may serve to restrict the radial movement of the valve anchor 104 away from a longitudinal axis of the tubular member 482 (at least in part due to the shear strength of the coupling wire 484 adjacent to its insertion in the cavity 494).Furthermore, with a releasable adhesive to provide a degree of engagement, without adhesive (thus, only friction engagement), or with an interference fit (and high friction engagement), the distal end segment 488 of the engagement wire 484 can be adjusted and / or positioned within the cavity 494 in a manner to mitigate inadvertent or unintentional separation of the distal end segment 488 from the cavity 494, which can be overcome by an intentional proximal force exerted on the engagement wire 484 during release of the valve anchor 104. Other advantageous features of the clamping mechanism 480 are similar to those discussed above in relation to the embodiment illustrated in Figure 9 and will not be repeated in this document for brevity.

[00124] Therefore, in the embodiment of the clamping mechanism 480 illustrated in Figure 10, the coupling wire can be pulled proximally and, by applying sufficient proximal force, separated from its coupling with the end cap 490. The coupling wire 484 can then be withdrawn proximally in the tubular member 482 and thus allow the disengagement and separation of the valve anchor 104 from the tubular member 482. Petition 870250101744, dated 06 / 11 / 2025, page 50 / 124 45 / 78

[00125] According to yet another embodiment of the clamping mechanism described in this document, Figure 11 illustrates a clamping mechanism 500. The clamping mechanism 500 may comprise a tubular member 502 (shown as a transparent component) having a side opening 504 through which an anchor tab 510 of a valve anchor 512 may be inserted and engaged with a coupling wire 530. The clamping mechanism 500 may provide certain advantages over other embodiments described in this document, including simplicity of design, minimal components, and direct and simplified movements of the components thereof.

[00126] The 530 hook wire may comprise a proximal section 532 and a distal section 534. The proximal section may define a different dimension or gauge than the distal section 534. In some embodiments, the proximal section 532 may have a smaller gauge than the distal section 534. As noted above, in some embodiments, the 530 wire may be ground, formed from wires of different diameters and / or a hypotube that are coupled to each other, bent over themselves, or combinations thereof, to achieve a difference in the diameters of the proximal section 532 and the distal section 534. This difference in size or gauge of the proximal section 532 and the distal section 534 may allow the physician to have a higher degree of responsiveness (less or no longitudinal stretching) when retracting proximally or exerting a proximal force on the 530 hook wire due to the greater tensile strength of the proximal section 532 compared to the distal section 534.However, distal section 534 can also provide sufficient tensile strength to safely disengage from anchor tab 510, as discussed in this document.

[00127] According to the embodiment described in Figure 11, the anchor tab 510 can be pre-folded into a generally right-angle configuration or folded into the side opening 504 during assembly. Petition 870250101744, dated 06 / 11 / 2025, p. 51 / 124 46 / 78 gem. Therefore, the anchor tab 510 may be identical to the anchor tab 152 illustrated and described in various other embodiments described in this document, except for the configuration of the anchor tab 510 in a generally transverse direction with respect to a longitudinal axis of the anchor tab 510 or the longitudinal axis of the clamping mechanism 500.

[00128] As illustrated in Figure 11, the fold of the anchor tab 510 may form a plug or insertion portion 514 of the anchor tab 510 that may be inserted through the lateral opening 504 into a lumen 506 of the tubular member 502. The anchor tab 510 may comprise a slot 516 that may enter the lumen 506 to a sufficient depth to allow the distal section 534 of the engagement wire 530 to be inserted through the slot 516. In this manner, the engagement wire 530 may engage the anchor tab 510 and restrict the movement of the anchor tab 510 so that the anchor tab 510 is not permitted to exit the lateral opening 504.

[00129] In operation, the physician may proximally withdraw the coupling wire 530 in order to disengage the distal section 534 of the coupling wire 530 from the slot 516 of the anchor tab 510. Once disengaged, the anchor tab 510 may move freely relative to the tubular member 502, thus allowing radial expansion of the valve anchor 512. As noted above with respect to the clamping mechanism 450 shown in Figure 9, the lateral opening 504 may be opened in a direction away from a longitudinal axis of the placement device, so that when released, the valve anchor 512 may expand freely away from the clamping mechanism 500. Thus, the clamping mechanism 500 will not tend to interfere with the expansion of the valve anchor 512.

[00130] According to some embodiments, the tightening mechanism and the placement device described in this document also Petition 870250101744, dated 06 / 11 / 2025, page 52 / 124 47 / 78 can also be configured so that the anchor tab of the valve anchor includes a notch or protrusion that can overlap longitudinally or fit against a corresponding protrusion or notch on a distal end section of a coupling wire. By overlapping longitudinally and restricting within the lumen of the tubular member, the anchor tab and the coupling wire can also be restricted against longitudinal movement relative to each other, thus securing the anchor tab to the clamping mechanism.

[00131] For example, as shown in Figures 12A-13, the clamping mechanism 550 may comprise a tubular member 552 having a lumen 554 in which a coupling wire 556 may be positioned. The coupling wire 556 may comprise a distal end segment 558, a bulb end portion 560, and a reduced profile section 562.

[00132] The reduced profile section 562 may comprise a reduced diameter relative to an adjacent proximal section of the engagement wire 556. Furthermore, the bulb end portion 560 may comprise a generally cylindrical component attached to the reduced profile section 562 that has a larger diameter than the reduced profile section 562. However, according to some embodiments, the bulb end portion 560 and the reduced profile section 562 may be configured as a notch or slot formed in a distal portion of the engagement wire 556 that is compatible with, or configured to engage with, a respective protrusion or component of the valve anchor's anchor tab.

[00133] With respect to the embodiment illustrated in Figures 12A-12E, the clamping mechanism 550 can engage with a valve anchor 570 having an anchor tab 572 comprising a notched portion 574. The notched portion can be configured to receive at least one portion of the bulbous end portion. Petition 870250101744, dated 06 / 11 / 2025, p. 53 / 124 48 / 78 560 of the hitch wire 556 therein. Furthermore, the internal diameter of the lumen 554 can be dimensioned to allow a combined crossover profile or external profile of the anchor tab 572 and the distal end segment 558 of the hitch wire 556 to fit within the lumen 554 when they overlap longitudinally with each other, as shown in Figure 12A. Moreover, when overlapped longitudinally, the bulb end portion 560 of the hitch wire 556 will be constrained against or within the notch portion 574 of the anchor tab 572, and the reduced profile section 562 will generally constrain an enlarged end portion 580 of the anchor tab 572 so that the enlarged end portion 580 and the distal end segment overlap longitudinally with each other.In this way, the anchor tab 572 and the reduced profile section 562 are radially restrained so that the corresponding structures are actually engaged with each other and securely retain the anchor tab 572 within the lumen 554 of the tubular member 552.

[00134] Figures 12B-12E illustrate the gradual release and disengagement of the anchor tab 572 from within the lumen 554 of the tubular member 552. As shown in Figure 12B, the anchor tab 572 is engaged and secured within the lumen 554 in an initial position where the bulbous end portion 560 overlaps longitudinally with the notched portion 574 and the enlarged end portion 580 overlaps longitudinally with the reduced profile section 562. However, as the engagement wire 556 is moved distally in the direction shown by arrow 582 relative to the tubular member 552, the radial restraint of the inner surface of the lumen 554 of the tubular member 552 is removed, as shown in Figure 12C. Once the radial restriction created by the tubular member 552 is removed, the anchor tab 572 and the distal end segment 558 of the engagement wire 556 po Petition 870250101744, dated 06 / 11 / 2025, page 54 / 124 49 / 78 must be radially separated, as shown in Figure 12D.

[00135] Subsequently, as shown in Figure 12E, the coupling wire 556 can be proximally withdrawn in relation to and within the lumen 554 of the tubular member 552. The valve anchor 570 can then expand freely into apposition at the target site.

[00136] Figure 13 illustrates another embodiment in which a valve anchor 590 comprises an anchor tab 592 having opposing elongated segments 594, 596 that form or define a gap 598 between them. Similar to the embodiment discussed above in relation to Figures 12A-12E, the gap 598 can be configured to include corresponding recesses and protrusions that generally correspond to the shape of the bulbous end portion 560 and the reduced profile section 562 of the engagement wire 556. As described above in relation to Figures 12A-12E, the discussion of which is incorporated herein by reference and will not be repeated herein for brevity, the anchor tab 592 can longitudinally overlap the distal end segment 558 of the engagement wire 556 within the lumen 554 of the tubular member 552. In such a position, the anchor tab 592 will be securely engaged with the engagement wire 556 and prevented from disengaging from the clamping mechanism 550.Furthermore, as shown and discussed in relation to the steps illustrated in Figures 12B-12E, the anchor tab 592 can similarly be pushed out of the lumen 554 and released from engagement with the engagement wire 556.

[00137] The embodiments shown in Figures 12A-13 illustrate additional features or components of the anchor tab and engagement wire that allow a simplified structure to enhance an interference fit with the engagement wire and anchor tab within the lumen of the tubular member of the clamping mechanism. Furthermore, according to some embodiments, an advantage in some embodiments of the wire and anchor tab arrangement shown in Figure 13 is that Petition 870250101744, dated 06 / 11 / 2025, page 55 / 124 50 / 78 each clamping connection can be made individually by means of a temporary engagement by simply pressing the anchor tab onto the wire or clamping mechanism until the two notched legs engage by fitting over the bulbous end portion 560. Once all three connections are made, the cable can be actuated to pull all three wires into their respective tubular members, thus having the wider portion of the anchor tab 592 effectively locking or enclosing the bulbous end portion 560 in engagement within the gap 598. Such an arrangement can simplify the connection by providing a temporary connection on each wire, followed by a common locking actuation during assembly. This can advantageously provide simplified mechanical operation and easier assembly.

[00138] In addition, some embodiments may optionally comprise other interference fitting mechanisms that engage radially with the anchor tab of the valve anchor within the lumen of the tubular member. The proximal removal of such structures, which may be incorporated into the engagement wire or whose function may be performed by the engagement wire to create some radial constriction or interference, is shown in Figures 14-15B, for example. These additional embodiments illustrate principles of other components and configurations that may be prepared using aspects of some embodiments.

[00139] For example, Figure 14 illustrates an embodiment of a clamping mechanism 600 comprising a tubular member 602 having a lumen 604 and a coupling wire 606 disposed within the lumen 604. The coupling wire 606 may comprise a zigzag section 608 in a distal end portion thereof. The zigzag section 608 may have a configuration whereby the coupling wire 606 deviates from a generally straight configuration to have one or more bends along the length of the wire 606 in the zigzag section. Petition 870250101744, dated 06 / 11 / 2025, page 56 / 124 51 / 78 zag 608.

[00140] For example, the zigzag section 608 may be formed by having at least two, at least three, or more bends. As illustrated in Figure 14, the zigzag section 608 may comprise four bends by which the hitch wire 606 deviates from a generally straight form or configuration. The bends may form the first and second bends 610, 612, and the hitch wire 606 may further comprise a distal section 614 that extends distally beyond the second bend 612 within the lumen 604.

[00141] According to some embodiments, the tubular member 602 may comprise a slot 620 and an end opening 622. When coupled to a valve anchor, such as the valve anchor 104, the anchor tab 152 of the valve anchor 104 may be inserted into the end opening 622 of the tubular member and engaged with a portion of the coupling wire 606.

[00142] For example, as illustrated, slot 170 of anchor tab 152 can receive at least a portion of the second bend 612 and overlap longitudinally with the distal section 614 of the coupling wire 606. In this way, anchor tab 152 can be radially and longitudinally restricted, at least in part, due to the protrusion of the second bend 612 that inserts radially into slot 170 and is received therein to form an interference fit between anchor tab 152 and the distal section 614 of the coupling wire 606 within lumen 604. Thus, the size of lumen 604 may be sufficient to receive both the profile or diameter of the coupling wire 606 and the profile of anchor tab 152 so that they overlap longitudinally, but due to the insertion of the second bend 612 into slot 170, anchor tab 152 will not be able exiting the end opening 622 in the position illustrated in Figure 14.

[00143] Furthermore, because the first fold 610 can be inserted or be Petition 870250101744, dated 06 / 11 / 2025, p. 57 / 124 52 / 78 received through slot 620 of tubular member 602, the coupling wire 606 will tend to be longitudinally or actually restricted in relation to tubular member 602.

[00144] However, according to some embodiments, the hitch wire 606 can be approximately retracted using sufficient proximal force, thus pulling upwards on the first bend 610 to straighten the first bend 610 and exerting a similar traction / alignment force on the second bend 612. Consequently, as the zigzag section 608 is pulled approximately, the first and second bends 610, 612 can be straightened longitudinally, thus removing the interference fit between the anchor tab 152 and the second bend 612 of the hitch wire 606 within the lumen 604. Continuous proximal retraction of the hitch wire will cause the zigzag section 608 to be pulled to a location proximal to the slot 620 in the direction illustrated by arrow 630.As the anchor tab 152 is allowed to exit the end opening 622, the valve anchor 104 and the clamping mechanism 600 will be separated and disengaged from each other, thus allowing the valve anchor 104 to expand into apposition with the native valve tissue at the target site.

[00145] Figures 15A and 15B illustrate another embodiment that uses cross-sectional interference fits to cause engagement between an anchor tab of a valve anchor and a clamping mechanism, according to some embodiments.

[00146] Referring to Figure 15A, a clamping mechanism 650 may comprise a tubular member 652 having a lumen 654 and a coupling wire 656. The coupling wire 656 may comprise a tapered shape, like a wedge shape, which tapers in a distal direction so that the coupling wire 656 can be longitudinally overlapped onto an anchor tab 660 of a valve anchor 662. In Petition 870250101744, dated 06 / 11 / 2025, page 58 / 124 53 / 78 a first position 670, a reduced profile section 672 of the engagement wire 656 can be driven into radial engagement so as to form an interference fit along a proximal portion 674 of the anchor tab 660. The reduced profile section 672 may comprise a wedge or a conical shape, according to some embodiments.

[00147] As will be appreciated by persons skilled in the art, as the reduced-profile section 672 is driven distally relative to the anchor flange, the cross-sectional profile of the reduced-profile section 672 will increase until the total cross-sectional area of ​​the anchor flange 660 and the reduced-profile section 672 corresponds to an internal profile of the lumen 654 of the tubular member 652. In such a position, a projection 680 of the anchor flange 660, which extends through a lateral opening 682 of the tubular member 652, can be fully extended into the lateral opening 682. The presence of the projection 680 and its insertion into the lateral opening 682 can tend to ensure that the anchor flange 660 is unable to slide or translate relative to the tubular member 652, thus restricting the relative longitudinal movement thereof and keeping the anchor flange 660 within the lumen 654 of the clamping mechanism. 650.

[00148] However, as illustrated in Figure 15B, the engagement wire 656 can be approximately withdrawn into the lumen 654, thus approximately withdrawing the reduced profile section 672 away from the proximal portion 674 of the anchor tab 660. As the reduced profile section 672 is proximally withdrawn 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 lateral wall or inner surface of the lumen 654, thus allowing the protrusion 680 to exit the opening 682. As this occurs, the anchor tab 660 can be displaced and separated from the tubular member 652 after the protrusion 680 separates from the opening 682. Thus, Figure 15B illustrates the separation of the anchor from Petition 870250101744, dated 06 / 11 / 2025, page 59 / 124 54 / 78 valve 662 of tubular member 652.

[00149] Therefore, the simplicity of the designs and Figures 1415B can provide certainty and simplified action of the clamping mechanism, according to some embodiments. The simple proximal retraction of the coupling wire and the subsequent elimination of transverse interference between the anchor tab and the coupling wire can allow a simple separation and release of the valve anchor from the clamping mechanism in the operation of the implantation device.

[00150] According to yet another embodiment described in this document, Figures 16A and 16B illustrate another clamping mechanism, according to some embodiments. Figure 16A illustrates a clamping mechanism 700 that may comprise a tubular member 702 having a lumen 704 configured to receive a coupling wire 706 and a distal end section 708 configured to limit a degree of freedom of movement of a valve anchor 710 when coupled thereto.

[00151] As in other embodiments described in this document, the lumen 704 of the clamping mechanism 700 may receive a portion of the valve anchor 710, such as an anchor tab 712 of the valve anchor 710. Then, once the anchor tab 712 is in place within the lumen 704, the engagement wire 706 may be wound through proximal and distal openings 720, 722 to engage a slot or opening 724 of the anchor tab 712, as shown in Figure 16B. The valve anchor 710 will be securely engaged relative to the clamping mechanism 700, as with other embodiments described in this document that limit the relative axial or longitudinal movement between the anchor tab 712 of the valve anchor 710 and the clamping mechanism 700.

[00152] However, according to some embodiments, the distal end section 708 and / or the lumen 704 may advantageously Petition 870250101744, dated 06 / 11 / 2025, page 60 / 124 55 / 78 can be configured to limit an additional degree of freedom of movement of the anchor tab 712 when coupled to it. In this way, some embodiments may tend to provide a more rigid interconnection between the clamping device.

[00153] For example, lumen 704 can restrict the rotational movement of anchor tab 712 relative to and within lumen 704. This can be achieved by forming anchor tab 712 with a polygonal cross-section, such as a rectangle, square, or triangle, or another shape having one or more protruding corners, flanges, or tabs that can engage with a corresponding structure or shape of anchor tab 712 in order to restrict the rotational movement of anchor tab 712 relative to lumen 704. By restricting the rotational movement between them, the valve anchor 710 will tend to move in unison with the clamping mechanisms 700 of the clamping device, thus creating more control and precision when placing the valve anchor 710.

[00154] Therefore, according to some embodiments, the anchor tab 712 may have a profile or cross-sectional shape that is configured to mate with a corresponding profile or cross-sectional shape of the lumen 704. The cross-sectional shape of the anchor tab may comprise a rectangle having chamfered corners 730 that allow the flat surfaces formed by the sides of the rectangular shape to provide rotational restraint, while the chamfered corners 730 allow the anchor tab 712 to be able to slide within the lumen 704 with some ease.

[00155] As generally illustrated in Figure 16A, according to some embodiments, the chamfered corners 730 may comprise a radius of curvature that is between about 10% and about 50% of the distance from one side of the rectangular anchor flange profile 712, such as about 1 / 7, 1 / 6, 1 / 5, 1 / 4 or about 1 / 3 of the distance from Petition 870250101744, dated 06 / 11 / 2025, page 61 / 124 56 / 78 one side of the rectangular anchor flange profile 712. Furthermore, the rectangular anchor flange profile 712 can define a length ratio of adjacent sides of approximately 2:3, 1:2, 1:3, 1:4 or 1:5.

[00156] In some embodiments, the rectangular profile of the anchor flange 712 may provide a flange width that is at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or one hundred percent greater than a slot width 724 that extends through the anchor flange 712.

[00157] Optionally, as shown in Figure 17, the distal end section may be formed to include an anchor slot or bay in which the anchor may be at least partially received to provide additional rotational restraint between the clamping mechanism and the valve anchor.

[00158] As illustrated, the clamping mechanism 750 may comprise a tubular member 752 which includes a distal end section 754. The distal end section 754 comprises an anchor slot or bay 756 which provides a gap or space between opposing flanges 758. The valve anchor 760 may be received within the anchor slot 756 and fitted into the gap between the opposing flanges 758. The generally flat profile of the flanges 758 fits against the upper and lower edges of the valve anchor 760 along a width or length side of the anchor slot 756 to restrict rotational movement between them.

[00159] Thus, in some embodiments, with the anchor tab (not shown) of the valve anchor 760 being received in a lumen of the tubular member 752, the anchor slot 756 may further engage a base 762 of the anchor tab 760 and provide a restraint against relative rotational movement between the anchor 760 and the tubular member 752 about a longitudinal axis of the tubular member 752. Such embodiments may be implemented in combination with or Petition 870250101744, dated 06 / 11 / 2025, page 62 / 124 57 / 78 separately from the anchor flange having a specific cross-sectional profile to provide rotational restraint and engagement with the lumen of the tubular member, as discussed above in relation to Figures 16A and 16B.

[00160] Figures 16A-17 show that, in some embodiments, the tubular member may comprise a round (e.g., circular) outer profile along its entire length or at least a portion of its length. In addition, some embodiments may have a non-circular outer profile along their entire length or at least a portion of their length.

[00161] Furthermore, various embodiments throughout the present invention illustrate that the lumen of the tubular member may have an internal cross-sectional profile that is generally round (e.g., circular) or a luminal profile. Figures 16A and 16B illustrate that the tubular member may comprise a non-round (e.g., non-circular) luminal profile along at least a portion of its length. As noted above, the lumen may comprise a polygonal cross-section, such as a rectangle, square, or triangle, or other shape having one or more protruding corners, flanges, or tabs that may engage with a corresponding anchor tab structure or shape. Such a non-round luminal profile may be formed along the entire length of the tubular member or at least a portion of its length.

[00162] The shape of at least one portion of the external profile or luminal profile may be formed or adjusted by means of an extrusion process or by means of post-extrusion heating and deformation to alter the external profile or luminal profile as desired, using end-portion forming tools in which the tubular member is pressed to alter the external profile and / or luminal profile. Petition 870250101744, dated 06 / 11 / 2025, page 63 / 124 58 / 78

[00163] Furthermore, in some embodiments, a round or non-round outer profile may be along the entire length or only a portion of the length of the tubular member, while a round or non-round luminal profile extends along the entire length or only a portion of the length of the tubular member. Thus, the tubular member may have a round outer profile that changes to a non-round outer profile, along with a non-round luminal profile.

[00164] Therefore, according to some embodiments, a physician may manipulate the valve anchor by engaging or coupling a gripper to an anchor tab of a valve anchor. The gripper and anchor tab may be prevented from relative longitudinal, rotational, and / or radial movement by enclosing or interconnecting the gripper and anchor tab side-by-side, such as within or against a tubular casing. In order to disengage the gripper and anchor tab, the physician may withdraw or advance a coupling wire disposed within the gripper. This relative movement may cause or permit a displacement or separation between the gripper and anchor tab. Once separated, the valve anchor will tend to expand radially outward, thus disengaging the anchor tab from the gripper. Subsequently, the gripper may be retracted or withdrawn into the tubular casing. Illustration of the technology in question as Clauses

[00165] Several examples of aspects of the invention are described as sets of clauses with numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the technology in question. The figure identifications and reference numbers are provided below merely as examples and for illustrative purposes, and the clauses are not limited by these identifications.

[00166] Clause 1. A cardiac valve placement device Petition 870250101744, dated 06 / 11 / 2025, p. 64 / 124 59 / 78 prosthetic device comprising: a docking area defining a longitudinal axis; and a coupling wire extending along the longitudinal axis, the coupling wire comprising a first section, a second section, and a loop section interposed between the first section and the second section along the coupling wire, the coupling wire having (i) an engaged position in which the loop section extends through the docking area and the second section overlaps at least partially longitudinally with the first section to facilitate engagement between the placement device and a heart valve prosthesis in the docking area and (ii) a disengaged position in which the second section is positioned distal to the loop section and the first section to allow disengagement of the heart valve prosthesis from the docking area.

[00167] Clause 2. The placement device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the fitting area.

[00168] Clause 3. The placement device, according to Clause 2, in which the coupling wire extends through the lumen.

[00169] Clause 4. The placement device, according to either Clause 2 or 3, in which the fitting area is configured to receive a protrusion or flap of the heart valve prosthesis thereon.

[00170] Clause 5. The placement device, according to any of Clauses 2 to 4, wherein the tubular member comprises at least one opening extending through a side wall thereof to the lumen thereof, and wherein in the engaged position, the engagement wire is positioned within the lumen and extends through the opening.

[00171] Clause 6. The placement device, in accordance with Petition 870250101744, dated 06 / 11 / 2025, p. 65 / 124 60 / 78 any of Clauses 2 to 5, wherein the tubular member comprises a more distal set of openings extending through a lateral wall of the tubular member towards the lumen thereof, the engagement wire extending through the more distal set of openings to facilitate engagement between the placement device and the heart valve prosthesis in the docking area.

[00172] Clause 7. The placement device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the fitting area, the tubular member comprising four openings extending from an outer surface of the tubular member to the lumen, wherein: the coupling wire is disposed through a first opening and a second opening so that the second section of the coupling wire is disposed outside the lumen; the coupling wire is disposed through the second opening and a third opening so that a second segment of the coupling wire extends through the fitting area within the lumen; the coupling wire is disposed through the third opening and a fourth opening so that the third segment of the coupling wire is disposed outside the lumen; and the coupling wire is disposed through the fourth opening so that a fourth segment of the coupling wire is disposed outside the lumen.

[00173] Clause 8. The placement device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the fitting area, the tubular member comprising four openings extending from an outer surface of the tubular member to the lumen, wherein the proximal and distal segments of the coupling wire are disposed within the lumen, the coupling wire passing through the four openings to form a loop segment extending through the fitting area within the lumen. Petition 870250101744, dated 06 / 11 / 2025, p. 66 / 124 61 / 78

[00174] Clause 9. The fitting device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the fitting area, the tubular member comprising the first, second, third, and fourth openings extending from an outer surface of the tubular member to the lumen, each of the first and fourth openings having a longitudinal axis extending transversely in relation to a longitudinal axis of the tubular member, each of the second and third openings having a longitudinal axis extending substantially perpendicular in relation to a longitudinal axis of the tubular member.

[00175] Clause 10. The placement device, according to Clause 9, in which the second and third openings are arranged in approximately equal longitudinal positions along the longitudinal axis of the tubular member.

[00176] Clause 11. The placement device, according to either Clause 9 or 10, wherein the first opening is interposed between the fourth opening and the second and third openings along the longitudinal axis of the tubular member.

[00177] Clause 12. The placement device, in accordance with any of Clauses 9 to 11, wherein the first opening is offset longitudinally from the second, third and fourth openings along the longitudinal axis of the tubular member.

[00178] Clause 13. The fitting device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the fitting area, the tubular member including a plurality of openings extending from an outer surface of the tubular member to the lumen, the coupling wire extending through the lumen and the plurality of openings. Petition 870250101744, dated 06 / 11 / 2025, p. 67 / 124 62 / 78

[00179] Clause 14. The placement device, according to Clause 13, in which at least one opening is longitudinally offset from another opening along the longitudinal axis of the tubular member.

[00180] Clause 15. The placement device, according to any of the preceding Clauses, further comprising a tubular member having a lumen that defines at least partially the docking area, an open end that allows access to the docking area, and a plurality of openings extending from an outer surface of the tubular member into the lumen to allow the engagement wire to extend outward and into the lumen and through the docking area to engage a portion of the heart valve prosthesis extending to the open end of the tubular member.

[00181] Clause 16. The placement device, according to any of the preceding Clauses, further comprising three tubular members that form the respective fitting areas for engaging the valve with it.

[00182] Clause 17. The placement device, according to Clause 16, further comprising a proximal sheath into which the three tubular members extend, the proximal sheath being retractable to allow expansion of the heart valve prosthesis and three tubular members before disengagement of the heart valve prosthesis placement device.

[00183] Clause 18. The placement device, according to any of the preceding Clauses, wherein the fitting area comprises a housing with an opening to receive a portion of the heart valve prosthesis to allow coupling between the heart valve prosthesis and the placement device.

[00184] Clause 19. The placement device, in accordance with Petition 870250101744, dated 06 / 11 / 2025, p. 68 / 124 63 / 78 any of the preceding Clauses, further comprising a tubular member with a lumen and a more distal pair of openings extending from an external surface of the tubular member into the lumen, the more distal pair of openings being diametrically opposite and positioned in a first longitudinal position along a longitudinal axis of the tubular member, the engagement wire extending through the more distal pair of openings into the lumen and through the engagement area to allow engagement with the heart valve prosthesis.

[00185] Clause 20. The placement device, according to Clause 19, wherein the first longitudinal position is defined at a first distance from an end of the tubular member, wherein the heart valve prosthesis comprises an elongated flap having a base and an opening that extends through the elongated flap, wherein the first distance is approximately equal to a distance from an edge of the opening and the base to allow a tight fit and minimize relative movement between the elongated flap and the tubular member in the engaged position.

[00186] Clause 21. A prosthetic heart valve placement device for placing a prosthetic heart valve, the device comprising: a core member defining a longitudinal axis; a proximal sheath extending over the core member; and a plurality of clamping mechanisms extending along the longitudinal axis within the proximal sheath to engage the prosthetic heart valve, each clamping mechanism comprising a longitudinal axis, an elongated fitting area extending along the longitudinal axis, and a coupling wire extending along the clamping mechanism, the coupling wire comprising a proximal section and a loop section, the loop section extending through the fitting area in a direct transverse direction relative to the longitudinal axis to facilitate engagement between the clamping mechanism and Petition 870250101744, dated 06 / 11 / 2025, p. 69 / 124 64 / 78 the heart valve prosthesis in an engaged configuration, the engagement wire being proximally retractable to proximally remove the loop section from the engagement area to disengage the heart valve prosthesis clamping mechanism in an unengaged configuration.

[00187] Clause 22. The placement device, according to Clause 21, in which the plurality of clamping mechanisms comprises three clamping mechanisms.

[00188] Clause 23. The fitting device, according to either Clause 21 or 22, wherein each clamping mechanism comprises a tubular member in which the fitting area is disposed.

[00189] Clause 24. The placement device, according to Clause 23, wherein the tubular member comprises a plurality of openings extending through a side wall of the tubular member into a lumen thereof, the plurality of openings being configured to allow the passage of the coupling wire through it.

[00190] Clause 25. The placement device, according to Clause 24, wherein the plurality of openings comprises a pair of opposite openings positioned approximately in the same axial position with respect to a longitudinal axis of the tubular member, the opposite openings being substantially diametrically opposite to each other.

[00191] Clause 26. The placement device, according to Clause 25, in which the coupling wire passes through opposite openings to cross the fitting area in the engaged configuration.

[00192] Clause 27. The placement device, in accordance with either Clause 25 or 26, in which the plurality of openings further includes at least one proximal opening in the limb. Petition 870250101744, dated 06 / 11 / 2025, p. 70 / 124 65 / 78 tubular, proximal to the pair of opposing openings, with at least one proximal opening configured to allow the hook wire to extend from the lumen and to a location outside the lumen along the tubular member.

[00193] Clause 28. The placement device, in accordance with any of Clauses 24 to 27, where the plurality of openings comprises four openings.

[00194] Clause 29. The placement device, in accordance with any of Clauses 24 to 28, where the plurality of openings comprises five openings.

[00195] Clause 30. The placement device, according to Clause 23, wherein the tubular member comprises an elongated receptacle disposed along a lateral wall of the tubular member.

[00196] Clause 31. The placement device, according to Clause 30, in which the receptacle extends at least partially into the side wall, the receptacle having an axial length that is greater than its width.

[00197] Clause 32. The placement device, according to either Clause 30 or 31, wherein the receptacle comprises a raised area defined by a recess along a length of the receptacle which is configured to receive a portion of the heart valve prosthesis therein, the raised area restricting at least one degree of freedom of movement of the portion of the heart valve prosthesis.

[00198] Clause 33. The placement device, according to Clause 32, wherein the receptacle comprises a pair of opposing rail portions extending at least partially along the length of the receptacle, the opposing rail portions being configured to laterally restrict the movement of at least one portion of the heart valve prosthesis. Petition 870250101744, dated 06 / 11 / 2025, p. 71 / 124 66 / 78

[00199] Clause 34. The placement device, according to Clause 33, wherein in the engaged configuration, the loop section of the engagement wire extends from a lumen of the tubular member through the receptacle out of the lumen to engage with the heart valve prosthesis.

[00200] Clause 35. The placement device, according to Clause 34, wherein the tubular member comprises a pair of opposing openings extending through a side wall of the tubular member from the lumen thereof, the pair of opposing openings generally being diametrically opposed with respect to each other around the tubular member, wherein the loop section of the coupling wire extends through the receptacle, through the pair of opposing openings, through the lumen and to opposite external surfaces of the tubular member.

[00201] Clause 36. The placement device, according to Clause 35, wherein the tubular member comprises proximal openings extending through the lateral wall of the tubular member, wherein in the engaged configuration, the engagement wire extends, sequentially, out of the lumen through a proximal opening, into the lumen through another proximal opening, through the receptacle and the engagement area to a location outside the lumen, through the pair of opposite openings to pass through the lumen and out of the lumen, and into yet another proximal opening in the lumen.

[00202] Clause 37. The placement device, according to any of Clauses 34 to 36, wherein the tubular member comprises an end-covering member arranged so that a distal end of the tubular member, the end-covering member being configured to be coupled to a distal end of the attachment wire to secure the attachment wire extending from the lumen over the receptacle to facilitate engagement with the prosthesis. Petition 870250101744, dated 06 / 11 / 2025, page 72 / 124 67 / 78 heart valve in the engaged configuration.

[00203] Clause 38. The placement device, according to Clause 37, in which the end cover member is loosely coupled to the end cover member.

[00204] Clause 39. The placement device, according to Clause 38, in which the end cover member is adhesively or mechanically coupled to the end cover member.

[00205] Clause 40. The placement device, according to any of Clauses 21 to 39, wherein the engagement wire comprises a pull wire and a loop wire, the loop wire having an opening structure through which the pull wire can extend in the engaged configuration, wherein the pull wire is proximally retractable to disengage from the opening structure to allow separation of the pull wire from the loop wire, the pull wire and the loop wire being proximally retractable relative to the engagement area to allow disengagement from the heart valve prosthesis clamping mechanism.

[00206] Clause 41. The placement device, according to Clause 40, wherein each clamping mechanism comprises a tubular member in which the fitting area is disposed, the tubular member comprising a lumen configured to receive the traction wire and the loop wire after proximal retraction of the traction wire and the loop wire.

[00207] Clause 42. The placement device, according to Clause 41, wherein the tubular member comprises a pair of opposing openings extending through a side wall of the tubular member from the lumen thereof, the pair of opposing openings generally being diametrically opposed to each other around the tubular member, wherein the loop wire extends through the pair of opposing openings through the fitting area, the loop wire Petition 870250101744, dated 06 / 11 / 2025, p. 73 / 124 68 / 78 being engaged by the traction wire within the lumen of the tubular member.

[00208] Clause 43. A prosthetic heart valve placement device for placing a heart valve prosthesis, the device comprising: a clamping mechanism comprising a longitudinal axis, a tubular member with a lumen, a fitting opening extending through a lateral wall of the tubular member into the lumen, and a coupling wire extending through the lumen towards the fitting opening, the coupling wire being configured to pass and engage a slot or opening of a closing tongue of the heart valve prosthesis, the coupling wire generally extending parallel to the longitudinal axis and the closing tongue generally extending transversely to the longitudinal axis to facilitate engagement between the clamping mechanism and the heart valve prosthesis in an engaged configuration,The engagement wire being proximally retractable from the slot or opening of the closing tongue to disengage the heart valve prosthesis clamping mechanism in a disengaged configuration.

[00209] Clause 44. The placement device, according to Clause 43, wherein the coupling wire comprises a straight wire.

[00210] Clause 45. The fitting device, according to any of Clauses 43 to 44, in which the fitting opening extends in a transverse direction relative to the longitudinal axis along the side wall of the tubular member.

[00211] Clause 46. The fitting device, according to any of Clauses 43 to 45, wherein the device comprises a plurality of clamping mechanisms, wherein the fitting opening of each clamping mechanism is oriented in a direction away from other clamping mechanisms.

[00212] Clause 47. The prosthetic heart valve placement device comprising: a clamping mechanism comprising Petition 870250101744, dated 06 / 11 / 2025, page 74 / 124 69 / 78 a longitudinal axis, a tubular member with a lumen and an open end, and a coupling wire extending through the lumen toward the open end, the coupling wire having a distal end segment having a protrusion or recess configured to abut a respective recess or protrusion of a latch tongue of a heart valve prosthesis to form a component coupling, wherein: in an engaged configuration, the distal end segment and the latch tongue overlap longitudinally within the lumen and collectively define a cross-sectional profile that is less than an internal diameter of the lumen so that the movement of the distal end segment and the latch tongue is radially restricted by the lumen to restrict the movement of the distal end segment relative to the latch tongue,and the distal end segment of the engagement wire can be moved distally out of the lumen to allow the distal end segment and the locking tab to become radially displaced from each other into a disengaged configuration to allow the locking tab to move freely away from the engagement wire to disengage the heart valve prosthesis from the clamping mechanism.

[00213] Clause 48. The placement device, according to Clause 47, wherein the distal end segment of the attachment wire comprises an elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[00214] Clause 49. The placement device, according to either Clause 47 or 48, wherein the distal end segment of the attachment wire comprises a pair of elongated clamps, each elongated clamp having an enlarged end portion. Petition 870250101744, dated 06 / 11 / 2025, page 75 / 124 70 / 78 and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[00215] Clause 50. The placement device, according to Clause 49, wherein each elongated clamp comprises a lateral protrusion, each lateral protrusion extending radially from a surface of the elongated clamp in a direction away from both elongated clamps, the lateral protrusions being configured to contact an inner surface of the lumen to maintain engagement between the distal end segment and the locking tongue of the heart valve prosthesis.

[00216] Clause 51. The placement device, according to any of Clauses 47 to 50, wherein the distal end segment comprises opposing double hooks configured to engage the locking tongue of the heart valve prosthesis.

[00217] Clause 52. A prosthetic heart valve system comprising the placement device, according to any one of Clauses 47 to 50, and a heart valve prosthesis comprising a locking tongue, the locking tongue having an elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

[00218] Clause 53. A prosthetic heart valve system comprising the placement device, according to any one of Clauses 47 to 50, and a heart valve prosthesis comprising a locking tongue, the locking tongue having a pair of elongated clamps, each elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a profile Petition 870250101744, dated 06 / 11 / 2025, page 76 / 124 71 / 78 transverse smaller than the enlarged end portion.

[00219] Clause 54. The system, according to Clause 53, wherein each elongated clamp comprises a lateral protrusion, each lateral protrusion extending radially from a surface of the elongated clamp in a direction away from both elongated clamps, the lateral protrusions being configured to contact an internal surface of the lumen to maintain the engagement between the distal end segment and the locking tongue of the heart valve prosthesis.

[00220] Clause 55. The system, according to either Clause 53 or 54, wherein the locking tongue comprises opposing double hooks configured to engage the distal end segment of the engagement wire in the engaged configuration.

[00221] Clause 56. A prosthetic heart valve placement device comprising: a clamping mechanism comprising: a tubular member with a lumen, a lateral opening extending from the lumen to an external surface of the tubular member, and an open end; and a coupling wire extending through the lumen towards the open end, the coupling wire having a distal end segment configured to overlap at least partially longitudinally with a locking tongue of a prosthetic heart valve positioned within the lumen;wherein (i) in an engaged position, the distal end segment is in a first position that overlaps longitudinally with the locking tongue within the lumen to create an interference fit within the lumen to cause an engagement structure coupled to the engagement wire or locking tongue to project into the lateral opening of the tubular member and thus restrict the longitudinal movement of the locking tongue relative to the tubular member, and wherein (ii) in a disengaged position, the distal end segment is positioned in a; Petition 870250101744, dated 06 / 11 / 2025, page 77 / 124 72 / 78 second position, proximal to the first position, in which the distal end segment and the locking tongue release the interference fit and allow the engagement structure to withdraw from the lateral opening, thus allowing longitudinal movement of the locking tongue in relation to the tubular member.

[00222] Clause 57. The placement device, according to Clause 56, wherein the distal end segment of the engagement wire comprises a zigzag section with first and second bends, wherein in the engaged position, the first bend is configured to be received within the lateral opening of the tubular member and the second bend is configured to engage with an opening of the locking tongue.

[00223] Clause 58. The placement device, according to Clause 57, wherein the distal end segment comprises a straight most distal section, distal to the first and second folds, configured to overlap longitudinally the locking tongue within the lumen in the engaged position to assist in creating the interference fit.

[00224] Clause 59. The placement device, according to any of Clauses 56 to 58, wherein the distal end segment of the coupling wire comprises a tapered cross-sectional profile that tapers in a distal direction.

[00225] Clause 60. The placement device, according to Clause 59, wherein the distal end segment comprises a wedge section that tapers in a distal direction.

[00226] Clause 61. The placement device, according to either Clause 59 or 60, wherein the distal end segment comprises a flat surface configured to abut the locking tongue.

[00227] Clause 62. A prosthetic heart valve system Petition 870250101744, dated 06 / 11 / 2025, page 78 / 124 73 / 78 comprising the placement device, according to Clause 56, and a heart valve prosthesis having a locking tongue, wherein the locking tongue comprises an elongated body with a protrusion extending in a transverse direction relative to a longitudinal access of the elongated body, the protrusion being configured to project into the lateral opening of the tubular member to restrict the longitudinal movement of the locking tongue relative to the tubular member when the locking tongue is in the engaged position with the engagement wire of the placement device.

[00228] Clause 63. A prosthetic heart valve placement device comprising any of the features mentioned in any of the preceding Clauses.

[00229] Clause 64. A prosthetic heart valve system comprising a heart valve prosthesis and a prosthetic heart valve placement device comprising any of the features mentioned in Clauses 1 to 62.

[00230] Clause 65. A method of assembling a prosthetic heart valve placement device mentioned in any of the preceding Clauses.

[00231] Clause 66. A method of placing a prosthetic heart valve placement device mentioned 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 placement device.

[00232] Clause 67. The devices, systems and methods mentioned in any of the clauses above, wherein the anchor flange comprises a protrusion or cross-sectional profile configured to engage with a corresponding recess or cross-sectional profile of the tubular member to restrict the relative rotation between the anchor flange and the tubular member when the anchor flange is received. Petition 870250101744, dated 06 / 11 / 2025, page 79 / 124 74 / 78 within the lumen.

[00233] Clause 68. The devices, systems and methods mentioned in any of the above clauses, wherein a distal end portion of the tubular member comprises an anchor slot configured to receive a portion of the valve anchor therein to restrict the relative rotation between the valve anchor and the distal end portion about a longitudinal axis of the tubular member. Additional considerations

[00234] In some embodiments, any of the clauses in this document may depend on any of the independent clauses or any of the dependent clauses. In some embodiments, any of the clauses (e.g., dependent or independent clauses) may be combined with any other clauses (e.g., dependent or independent clauses). In some embodiments, a claim may include some or all of the words (e.g., steps, operations, means, or components) quoted in a clause, phrase, sentence, or paragraph. In some embodiments, a claim may include some or all of the words quoted in one or more clauses, phrases, sentences, or paragraphs. In some embodiments, some of the words in each of the clauses, phrases, sentences, or paragraphs may be removed.In some embodiments, additional words or elements may be added to a clause, phrase, sentence, or paragraph. In some embodiments, the technology in question may be implemented without using some of the components, elements, functions, or operations described in this document. In some embodiments, the technology in question may be implemented using additional components, elements, functions, or operations.

[00235] The previous description is provided to allow a person Petition 870250101744, dated 06 / 11 / 2025, p. 80 / 124 75 / 78 sound versed in the technique practice the various configurations described in this document. Although the technology in question has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustrative purposes only and should not be considered as limiting the scope of the technology in question.

[00236] There may be many other ways to implement the technology in question. Several functions and elements described in this document may be divided differently from those shown without departing from the scope of the technology in question. Several modifications to these configurations will be readily apparent to those skilled in the art, and the generic principles defined in this document may be applied to other configurations. Thus, many alterations and modifications may be made to the technology in question by a person skilled in the art without departing from the scope of the technology in question.

[00237] It is understood that the specific order or hierarchy of steps in the processes described is an illustration of exemplary approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The method accompanying the claims presents elements of the various steps in a sample order and is not intended to be limited to the specific order or hierarchy presented.

[00238] As used in this document, the term distal may denote a location or direction that is distant from a point of interest, such as the user or a control unit or region of the placement system that will be used to place a valve prosthesis into a native tubular valve ring. Additionally, the term proximal may denote a location or direction that is closer to a point of interest. Petition 870250101744, dated 06 / 11 / 2025, page 81 / 124 76 / 78 interest, such as the user or a control unit or region of the placement system that will be used to place a valve prosthesis.

[00239] As used in this document, the phrase "at least one of" preceding a series of items, with the term "and" or "or" to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase "at least one of" does not require selection of at least one of each item listed; instead, the phrase allows for a meaning that includes at least one of any of the items and / or at least one of any combination of the items and / or at least one of each of the items. By way of 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.

[00240] Terms such as top, bottom, front, back and the like, as used in this invention, should be understood as referring to an arbitrary frame of reference, rather than the common gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface and a back surface may extend upward, downward, diagonally or horizontally in a gravitational frame of reference.

[00241] Furthermore, to the extent that the term include, have or similar terms are used in the description or claims, such term is intended to be inclusive in a manner similar to the term understand as understand is interpreted when used as a transitional word in a claim.

[00242] The word "exemplificative" is used in this document to mean serving as an example, instance, or illustration. Any modality described in this document as exemplary must not Petition 870250101744, dated 06 / 11 / 2025, p. 82 / 124 77 / 78 must not necessarily be interpreted as preferential or advantageous in relation to other modalities.

[00243] A reference to a singular element is not intended to mean one and only one, unless specifically indicated, but rather one or more. Masculine pronouns (e.g., he) include the feminine and external gender (e.g., she and her) and vice versa. The term some refers to one or more. Underlined and / or italicized titles and subtitles are used for convenience only, do not limit the technology in question, and are not referred to in connection with the interpretation of the description of the technology in question. All structural and functional equivalents to the elements of the various configurations described throughout this invention that are known or become known to those skilled in the art are expressly incorporated herein by reference and intended to be covered by the technology in question. Furthermore, nothing described in this document is intended to be dedicated to the public, regardless of whether such invention is explicitly cited in the description above.

[00244] Although the detailed description contains many specifications, they should not be interpreted as limiting the scope of the technology in question, but only as illustrating different examples and aspects of the technology in question. It should be appreciated that the scope of the technology in question includes other embodiments not discussed in detail above. Various other modifications, alterations, and variations may be made to the arrangement, operation, and details of the method and apparatus of the technology in question described in this document without departing from the scope of the present invention. Unless otherwise indicated, reference to an element in the singular is not intended to mean one and only one, unless explicitly indicated, but rather to mean one or more. Furthermore, it is not necessary for a device or method to address all problems that are solvable (or possess). Petition 870250101744, dated 06 / 11 / 2025, page 83 / 124 78 / 78 all the advantages that can be achieved) by different embodiments of the invention to be encompassed within the scope of the invention. The use in this document of "may" and derivatives thereof should be understood in the sense of "possibly" or "optionally" as opposed to an affirmative capability. Petition 870250101744, dated 06 / 11 / 2025, page 84 / 124

Claims

1 / 16 CLAIMS 1. A prosthetic heart valve placement device, characterized in that it comprises: a docking area defining a longitudinal axis; and a coupling wire extending along the longitudinal axis, the coupling wire comprising a first section, a second section, and a loop section interposed between the first section and the second section along the coupling wire, the coupling wire having (i) an engaged position in which the loop section extends through the docking area and the second section overlaps at least partially longitudinally with the first section to facilitate engagement between the placement device and a heart valve prosthesis in the docking area and (ii) a disengaged position in which the second section is positioned distal to the loop section and the first section to allow disengagement of the heart valve prosthesis from the docking area.

2. Placement device, according to claim 1, characterized in that it further comprises a tubular member with a lumen that at least partially defines the fitting area.

3. Placement device, according to claim 2, characterized in that the coupling wire extends through the lumen.

4. Placement device, according to claim 2 or 3, characterized in that the fitting area is configured to receive a protrusion or tab of the heart valve prosthesis thereon.

5. Placement device, according to any one of claims 2 to 4, characterized in that the tubular member comprises at least one opening extending through Petition 870250101744, dated 06 / 11 / 2025, page 85 / 124 2 / 16 of a side wall thereof to the lumen thereof, and in which, in the engaged position, the engagement wire is positioned within the lumen and extends through the opening.

6. Placement device, according to any one of claims 2 to 5, characterized in that the tubular member comprises a more distal set of openings extending through a lateral wall of the tubular member towards the lumen thereof, the engagement wire extending through the more distal set of openings to facilitate engagement between the placement device and the heart valve prosthesis in the docking area.

7. Placement device, according to claim 1, characterized in that it further comprises a tubular member with a lumen that at least partially defines the engagement area, the tubular member including four openings extending from an outer surface of the tubular member into the lumen, wherein: the engagement wire is disposed through a first opening and a second opening such that a first segment of the engagement wire is disposed outside the lumen; the engagement wire is disposed through the second opening and a third opening such that a second segment of the engagement wire extends through the engagement area within the lumen; the engagement wire is disposed through the third opening and a fourth opening such that the third segment of the engagement wire is disposed outside the lumen; and the engagement wire is disposed through the fourth opening such that a fourth segment of the engagement wire is disposed within the lumen.

8. Placement device, according to any of the preceding claims, characterized in that, as per Petition 870250101744, dated 06 / 11 / 2025, page 86 / 124 3 / 16, it further comprises a tubular member with a lumen that defines at least partially the fitting area, the tubular member including four openings that extend from an outer surface of the tubular member to the lumen, wherein the proximal and distal segments of the coupling wire are disposed within the lumen, the coupling wire passing through the four openings to form a loop segment that extends through the fitting area within the lumen.

9. A fitting device, according to any of the preceding claims, characterized in that it further comprises a tubular member with a lumen that at least partially defines the fitting area, the tubular member comprising the first, second, third, and fourth openings extending from an outer surface of the tubular member to the lumen, each of the first and fourth openings having a longitudinal axis that extends transversely relative to a longitudinal axis of the tubular member, each of the second and third openings having a longitudinal axis that extends substantially perpendicular relative to a longitudinal axis of the tubular member.

10. Placement device, according to claim 9, characterized in that the second and third openings are arranged in approximately equal longitudinal positions along the longitudinal axis of the tubular member.

11. Placement device, according to claim 9 or 10, characterized in that the first opening is interposed between the fourth opening and the second and third openings along the longitudinal axis of the tubular member.

12. Placement device, according to any one of claims 9 to 11, characterized in that the first opening is longitudinally offset from the second, third, and fourth openings along the longitudinal axis of the tubular member. Petition 870250101744, dated 06 / 11 / 2025, p. 87 / 124 4 / 16 13. A fitting device, according to any of the preceding claims, characterized in that it further comprises a tubular member with a lumen that at least partially defines the fitting area, the tubular member including a plurality of openings extending from an outer surface of the tubular member to the lumen, the engagement wire extending through the lumen and the plurality of openings.

14. Placement device, according to claim 13, characterized in that at least one opening is offset longitudinally from another opening along the longitudinal axis of the tubular member.

15. Placement device, according to any of the preceding claims, characterized in that it further comprises a tubular member with a lumen that at least partially defines the docking area, an open end that allows access to the docking area, and a plurality of openings extending from an outer surface of the tubular member into the lumen to allow the engagement wire to extend outward and into the lumen and through the docking area to engage a portion of the heart valve prosthesis that extends to the open end of the tubular member.

16. A placement device, according to any of the preceding claims, characterized in that it further comprises three tubular members that form the respective fitting areas for engaging the valve therewith.

17. Placement device, according to claim 16, characterized in that it further comprises a proximal sheath into which the three tubular members extend, the proximal sheath being retractable to allow expansion of the heart valve prosthesis and three tubular members before disengagement of the heart valve prosthesis delivery device. Petition 870250101744, dated 06 / 11 / 2025, page 88 / 124 5 / 16 18. Placement device, according to any of the preceding claims, characterized in that the docking area comprises a housing with an opening to receive a portion of the heart valve prosthesis to allow coupling between the heart valve prosthesis and the placement device.

19. Placement device, according to any of the preceding claims, characterized in that it further comprises a tubular member with a lumen and a more distal pair of openings extending from an outer surface of the tubular member into the lumen, the more distal pair of openings being diametrically opposed and positioned in a first longitudinal position along a longitudinal axis of the tubular member, the engagement wire extending through the more distal pair of openings into the lumen and through the engagement area to allow engagement with the heart valve prosthesis.

20. Placement device, according to claim 19, characterized in that the first longitudinal position is defined at a first distance from an end of the tubular member, wherein the heart valve prosthesis comprises an elongated flap having a base and an opening that extends through the elongated flap, wherein the first distance is approximately equal to a distance from an edge of the opening and the base to allow a tight fit and minimize the relative movement between the elongated flap and the tubular member in the engaged position.

21. Prosthetic heart valve placement device to provide a heart valve prosthesis, characterized in that it comprises: a core member defining a longitudinal axis; a proximal sheath extending over the core member. Petition 870250101744, dated 06 / 11 / 2025, page 1.89 / 124 6 / 16 core; and a plurality of clamping mechanisms extending along the longitudinal axis within the proximal sheath to engage the heart valve prosthesis, each clamping mechanism comprising a longitudinal axis, an elongated fitting area extending along the longitudinal axis, and a coupling wire extending along the clamping mechanism, the coupling wire comprising a proximal section and a loop section, the loop section extending through the fitting area in a transverse direction relative to the longitudinal axis to facilitate engagement between the clamping mechanism and the heart valve prosthesis in a coupled configuration, the coupling wire being proximally retractable to proximally pull the loop section out of the fitting area to disengage the clamping mechanism from the heart valve prosthesis in a disengaged configuration.

22. A placement device according to claim 21, characterized in that the plurality of clamping mechanisms comprises three clamping mechanisms.

23. A fitting device, according to claim 21 or 22, characterized in that each clamping mechanism comprises a tubular member in which the fitting area is disposed.

24. Placement device, according to claim 23, characterized in that the tubular member comprises a plurality of openings extending through a side wall of the tubular member into a lumen thereof, the plurality of openings being configured to allow the passage of the coupling wire through the same.

25. Placement device, according to claim 24, characterized in that the plurality of openings Petition 870250101744, dated 06 / 11 / 2025, page 90 / 124 7 / 16 comprises a pair of opposing openings positioned approximately in the same axial position with respect to a longitudinal axis of the tubular member, the opposing openings being substantially diametrically opposed to each other.

26. A placement device, according to claim 25, characterized in that the coupling wire passes through opposite openings to cross the engagement area in the coupled configuration.

27. Placement device, according to claim 25 or 26, characterized in that the plurality of openings further comprises at least one proximal opening in the tubular member, proximal to the pair of opposing openings, at least one proximal opening being configured to allow the engagement wire to extend from the lumen and to a location outside the lumen along the tubular member.

28. A placement device, according to any one of claims 24 to 27, characterized in that the plurality of openings comprises four openings.

29. A placement device, according to any one of claims 24 to 28, characterized in that the plurality of openings comprises five openings.

30. Placement device, according to claim 23, characterized in that the tubular member comprises an elongated receptacle disposed along a lateral wall of the tubular member.

31. A placement device, according to claim 30, characterized in that the receptacle extends at least partially into the side wall, the receptacle having an axial length that is greater than its width.

32. Placement device, according to claim 30 or 31, characterized in that the receptacle comprises a raised area defined by a recess along a length of the receptacle that is configured to receive a portion of the heart valve prosthesis therein, the raised area restricting at least one degree of freedom of movement of the portion of the heart valve prosthesis.

33. Placement device, according to claim 32, characterized in that the receptacle comprises a pair of opposing rail portions extending at least partially along the length of the receptacle, the opposing rail portions being configured to laterally restrict the movement of at least one portion of the heart valve prosthesis.

34. Placement device, according to claim 33, characterized in that in the engaged configuration, the loop section of the engagement wire extends from a lumen of the tubular member through the receptacle out of the lumen to engage with the heart valve prosthesis.

35. Placement device, according to claim 34, characterized in that the tubular member comprises a pair of opposing openings extending through a side wall of the tubular member from the lumen thereof, the pair of opposing openings generally being diametrically opposed with respect to each other around the tubular member, wherein the loop section of the coupling wire extends through the receptacle, through the pair of opposing openings, through the lumen and to opposite outer surfaces of the tubular member.

36. Placement device, according to claim 35, characterized in that the tubular member comprises proximal openings extending through the lateral wall of the tubular member, wherein in the coupled configuration, the coupling wire extends, sequentially, out of the lumen through a proximal opening, into the lumen through another proximal opening, through the receptacle and the fitting area to a location outside the lumen, through the pair of opposite openings to pass through the lumen and out of the lumen, and into yet another proximal opening in the lumen.

37. Placement device, according to any one of claims 34 to 36, characterized in that the tubular member comprises an end cover member arranged such that a distal end of the tubular member, the end cover member being configured to be coupled to a distal end of the coupling wire to secure the coupling wire extending from the lumen over the receptacle to facilitate engagement with the heart valve prosthesis in the coupled configuration.

38. A placement device according to claim 37, characterized in that the end cover member is loosely coupled to the end cover member.

39. Placement device, according to claim 38, characterized in that the end cover member is adhesively or mechanically coupled to the end cover member.

40. Placement device, according to any one of claims 21 to 39, characterized in that the engagement wire comprises a pull wire and a loop wire, the loop wire having an opening structure through which the pull wire can extend in the coupled configuration, wherein the pull wire is proximally retractable to disengage from the opening structure to allow separation of the pull wire from the loop wire, the pull wire and the loop wire being proximally retractable relative to the engagement area to allow disengagement of the clamping mechanism of the cardiac valve prosthesis. Petition 870250101744, dated 06 / 11 / 2025, page 93 / 124 10 / 16 41. Placement device, according to claim 40, characterized in that each clamping mechanism comprises a tubular member in which the fitting area is disposed, the tubular member comprising a lumen configured to receive the traction wire and the loop wire after proximal retraction of the traction wire and the loop wire.

42. Placement device, according to claim 41, characterized in that the tubular member comprises a pair of opposing openings extending through a side wall of the tubular member from the lumen thereof, the pair of opposing openings generally being diametrically opposed with respect to each other around the tubular member, wherein the loop wire extends through the pair of opposing openings through the fitting area, the loop wire being engaged by the traction wire within the lumen of the tubular member.

43. Prosthetic heart valve placement device for providing a heart valve prosthesis, characterized in that it comprises: a clamping mechanism comprising a longitudinal shaft, a tubular member with a lumen, a fitting opening extending through a lateral wall of the tubular member into the lumen, and a coupling wire extending through the lumen towards the fitting opening, the coupling wire being configured to pass through and engage a slot or opening of an anchor flap of the heart valve prosthesis, the coupling wire generally extending parallel to the longitudinal axis and the anchor flap generally extending transversely to the longitudinal axis to facilitate engagement between the clamping mechanism and the heart valve prosthesis in a coupled configuration, the coupling wire being proxi Petition 870250101744, dated 06 / 11 / 2025, page.94 / 124 11 / 16 retractable from the slot or opening of the anchor tab to disengage the heart valve prosthesis clamping mechanism in a disengaged configuration.

44. Placement device, according to claim 43, characterized in that the coupling wire comprises a straight wire.

45. A fitting device, according to claim 43 or 44, characterized in that the fitting opening extends in a transverse direction relative to the longitudinal axis along the side wall of the tubular member.

46. ​​A placement device, according to any one of claims 43 to 45, characterized in that the device comprises a plurality of clamping mechanisms, wherein the fitting opening of each clamping mechanism is oriented in a direction away from other clamping mechanisms.

47. Device for placing a prosthetic heart valve, characterized in that it comprises: a clamping mechanism comprising a longitudinal shaft, a tubular member having a lumen and an open end and a coupling wire extending through the lumen towards the open end, the coupling wire having a distal end segment having a protrusion or recess configured to abut a respective recess or protrusion of an anchor flap of a prosthetic heart valve to form a component coupling, wherein: in an engaged configuration, the distal end segment and the anchor flap overlap longitudinally within the lumen and collectively define a cross-sectional profile that is less than an internal diameter of the lumen so that the movement of the distal end segment and the anchor flap is radially. Petition 870250101744, dated 06 / 11 / 2025, p.95 / 124 12 / 16 restricted by the lumen to restrict the movement of the distal end segment relative to the anchor flap, and the distal end segment of the engagement wire can be moved distally out of the lumen to allow the distal end segment and the anchor flap to become radially displaced from each other to a disengaged configuration to allow the anchor flap to move freely away from the engagement wire to disengage the heart valve prosthesis from the clamping mechanism.

48. Placement device, according to claim 47, characterized in that the distal end segment of the hook wire comprises an elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

49. Placement device, according to claim 47 or 48, characterized in that the distal end segment of the hook wire comprises a pair of elongated clamps, each elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

50. Placement device, according to claim 49, characterized in that each elongated pin comprises a lateral protrusion, each lateral protrusion extending radially from a surface of the elongated clamp in a direction away from both elongated clamps, the lateral protrusions being configured to contact an inner surface of the lumen to maintain engagement between the distal end segment and the anchor flap of the heart valve prosthesis. Petition 870250101744, dated 06 / 11 / 2025, pp. 96 / 124 13 / 16 51. Placement device, according to any one of claims 47 to 50, characterized in that the distal end segment comprises opposing double hooks configured to engage the anchor tab of the heart valve prosthesis.

52. Prosthetic heart valve system, characterized in that it comprises the placement device, as defined in any one of claims 47 to 50, and a heart valve prosthesis including an anchor flap, the anchor flap having an elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

53. Prosthetic heart valve system, characterized in that it comprises the placement device, as defined in any one of claims 47 to 52, and a heart valve prosthesis including an anchor flap, the anchor flap having a pair of elongated clamps, each elongated clamp having an enlarged end portion and a notched portion, the notched portion being proximal to the enlarged end portion and having a smaller cross-sectional profile than the enlarged end portion.

54. System according to claim 53, characterized in that each elongated clamp comprises a lateral protrusion, each lateral protrusion extending radially from a surface of the elongated clamp in a direction away from both elongated clamps, the lateral protrusions being configured to contact an inner surface of the lumen to maintain engagement between the distal end segment and the anchor flap of the heart valve prosthesis.

55. System, according to claim 53 or 54, characterized in that the anchor tab comprises double opposing hooks configured to engage the distal end segment of the engagement wire in the engaged configuration.

56. Device for placing a prosthetic heart valve, characterized in that it comprises: a clamping mechanism comprising: a tubular member with a lumen, a lateral opening extending from the lumen to an external surface of the tubular member and an open end; and a coupling wire extending through the lumen towards the open end, the coupling wire having a distal end segment configured to overlap at least partially longitudinally with an anchor flap of a prosthetic heart valve positioned within the lumen;wherein (i) in an engaged position, the distal end segment is in a first position that overlaps longitudinally with the anchor tab within the lumen to create an interference fit within the lumen to cause an engagement structure coupled to the engagement wire or anchor tab to project into the lateral opening of the tubular member and thus restrict the 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 withdraw from the lateral opening to thus allow longitudinal movement of the anchor tab relative to the tubular member.

57. Placement device, according to claim 56, characterized in that the distal end segment of the coupling wire comprises a zigzag section with first and second bends, wherein in the coupled position, the first bend is configured to be received within the lateral opening of the tubular member and the second bend is configured to engage with an opening of the anchor flap.

58. Placement device, according to claim 57, characterized in that the distal end segment comprises a straight, more distal section, distal to the first and second folds, configured to overlap longitudinally the anchor tab within the lumen in the engaged position to assist in creating the interference fit.

59. Placement device, according to any one of claims 56 to 58, characterized in that the distal end segment of the coupling wire comprises a tapered cross-sectional profile that tapers in a distal direction.

60. Placement device, according to claim 59, characterized in that the distal end segment comprises a wedge section that tapers in a distal direction.

61. Placement device, according to claim 59 or 60, characterized in that the distal end segment comprises a flat surface configured to abut the anchor tab.

62. Prosthetic heart valve system, characterized in that it comprises the placement device, as defined in any one of claims 56 to 61, and a heart valve prosthesis having an anchor flap, wherein the anchor flap comprises an elongated body with a protrusion extending in a transverse direction relative to a longitudinal axis of the elongated body, the protrusion being configured to project into the lateral opening of the tubular limb to restrict the longitudinal movement of the anchor flap relative to the tubular limb when the anchor flap is in the engaged position with the engagement wire of the placement device. Petition 870250101744, dated 06 / 11 / 2025, pages 99 / 124 16 / 16

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