Artificial valve and delivery assembly with positioning and stabilizing members

Abstract

This disclosure relates to a device designed to assist in the precise positioning and deployment of an artificial valve within a natural annular portion. In one embodiment, the delivery assembly comprises an artificial valve having a frame movable between a radially compressed configuration and an expanded configuration, and a delivery device. The delivery device includes an outer delivery shaft and at least one elongated positioning member extending through the outer delivery shaft and movable axially relative to the outer delivery shaft. The elongated positioning member is configured to position its distal end radially outward relative to the artificial valve and axially distal relative to the outflow end of the frame. In some embodiments, the delivery device may further include at least one sensor attached to the elongated positioning member.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims the interests of U.S. Provisional Patent Application No. 63 / 464,147, filed on 4 May 2023, which is incorporated herein by reference.

[0002] This disclosure relates to artificial valves and delivery assemblies equipped with positioning and / or stabilizing members, and to methods of using the same. [Background technology]

[0003] The human heart can be affected by various valvular heart diseases. These valvular heart diseases can cause serious cardiac dysfunction, ultimately requiring the repair of the original valve or its replacement with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical approaches, such as transcatheter aortic valve replacement (TAVR), are used in a variety of procedures to deliver artificial medical devices to locations inside the human body that are not easily accessible by surgery, or where surgical access is desirable.

[0004] Transcatheter vena cava valve replacement (TAVR) is an example of a minimally invasive surgical procedure used to replace the natural vena cava valve. In one specific example of the procedure described above, an expandable artificial heart valve is placed in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to the heart. The artificial heart valve is positioned within the natural valve and expanded to its functional size. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 10603165 [Patent Document 2] International application No. PCT / US2021 / 052745 [Patent Document 3] U.S. Provisional Application No. 63 / 085947 [Patent Document 4] U.S. Provisional Application No. 63 / 209904 [Patent Document 5] U.S. Patent No. 7993394 [Patent Document 6] U.S. Patent No. 9393110 [Patent Document 7] U.S. Patent No. 9155619 [Patent Document 8] U.S. Patent Application Publication No. 2018 / 0028310 [Patent Document 9] U.S. Patent No. 6730118 [Patent Document 10] U.S. Patent No. 7393360 [Patent Document 11] U.S. Patent No. 7510575 [Patent Document 12] U.S. Patent No. 8652202 [Patent Document 13] U.S. Patent No. 11135056 [Patent Document 14] U.S. Patent No. 9339384 [Patent Document 15] U.S. Patent No. 8007992 [Patent Document 16] U.S. Patent No. 8357387 [Overview of the project]

[0006] Numerous TAVR techniques are known in the art, including percutaneous, transarterial, transvenous, transcardiac, transarterial, transventricular, and / or trans-tip techniques. A critical factor in the placement of such transcatheter valves is the proper positioning of the prosthetic device, for example, accurately positioning the prosthetic valve within the natural cardiac annulus. For example, a prosthetic valve implanted too deeply relative to the natural annulus may cause conduction problems. In another embodiment, a prosthetic valve may be misaligned within the natural annulus, potentially dislodging from the implantation site and / or resulting in undesirable extravalvular leakage and regurgitation formed between the valve and the surrounding tissue. Therefore, it is desirable to provide devices and methods that can accurately position the prosthetic valve relative to the natural annulus during the implantation procedure.

[0007] In one of the basic configurations, the delivery assembly comprises an artificial valve and a delivery device having at least one elongated positioning member. This basic configuration may preferably include one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also include one or more of the configurations shown in the figures and / or described in conjunction with the figures, which are preferably additional to or alternative to the configurations of the embodiments described below.

[0008] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0009] In some embodiments, the delivery device may be configured to include a handle.

[0010] In some embodiments, the delivery device may be configured to include an external delivery shaft that optionally extends distally from the handle.

[0011] In some embodiments, at least one elongated positioning member is optionally extended through the outer delivery shaft and optionally movable axially relative to the outer delivery shaft.

[0012] In some embodiments, the delivery device may be configured to include at least one sensor attached to at least one elongated positioning member.

[0013] In some embodiments, at least one elongated positioning member is configured to optionally position its distal end radially outward relative to the artificial valve and axially distal relative to the outflow end of the frame.

[0014] In one of the basic methods, the method includes the step of advancing a delivery assembly, which comprises a delivery device carrying an artificial valve in a radially compressed configuration, onto a natural heart valve. Preferably, this basic method may provide one or more of the steps described elsewhere in this disclosure, in particular the steps of the embodiments described below. However, it will be understood that the basic method may also preferably provide one or more of the steps shown in the figures and / or described in conjunction with the figures, in addition to or instead of the steps of the embodiments described below.

[0015] In some embodiments, the method includes extending at least one elongated positioning member of the delivery device distally through the outer delivery shaft of the delivery device until the distal end of at least one elongated positioning member interacts with the proximal contact surface of a natural heart valve.

[0016] In some embodiments, the method includes the step of acquiring a measurement signal from at least one sensor attached to at least one elongated positioning member.

[0017] In some embodiments, the method optionally includes the step of expanding the artificial valve within the annular portion of a natural heart valve, wherein the distal end of at least one elongated positioning member is radially spaced away from the artificial valve.

[0018] In one of the basic configurations, the delivery assembly comprises an artificial valve and a delivery device having a positioning balloon. Preferably, this basic configuration may provide one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also provide one or more of the configurations shown in the figures and / or described in conjunction with the figures, preferably as additional or alternative configurations to the configurations of the embodiments described below.

[0019] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0020] In some embodiments, the delivery device may be configured to include a handle.

[0021] In some embodiments, the delivery device may be configured to include an external delivery shaft extending distally from the handle.

[0022] In some embodiments, the positioning balloon is freely movable between a deflated state and an inflated state.

[0023] In some embodiments, the delivery device may be configured to include an expansion tube connected to a positioning balloon and in fluid communication with the positioning balloon.

[0024] In some embodiments, the expansion tube optionally extends through the outer delivery shaft and optionally is axially movable relative to the outer delivery shaft.

[0025] In some embodiments, the expansion tube is optionally configured to position the positioning balloon radially outward relative to the prosthetic valve such that at least a portion of the positioning balloon extends axially distally to the outflow end of the frame.

[0026] In one of the basic configurations, the delivery assembly comprises an artificial valve and a delivery device equipped with a stabilizing filter. This basic configuration may preferably include one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also preferably include one or more of the configurations shown in the figures and / or described in conjunction with the figures, as additional or alternative configurations to the configurations of the embodiments described below.

[0027] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0028] In some embodiments, the delivery device may be configured to include a handle.

[0029] In some embodiments, the delivery device may be configured to include an outer delivery shaft optionally extending distally from the handle, and a stabilizing filter.

[0030] In some embodiments, the stabilization filter is optionally configured to transition between a folded state and an unfolded state.

[0031] In some embodiments, the stabilizing filter is optionally positioned proximal to the artificial valve.

[0032] In some embodiments, the stabilization filter may have a configuration that includes multiple pores.

[0033] In one of the basic configurations, the delivery assembly comprises a delivery device and an artificial valve including one or more positioning supports. Preferably, this basic configuration may provide one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also provide one or more of the configurations shown in the figures and / or described in conjunction with the figures, preferably as additional or alternative configurations to the configurations of the embodiments described below.

[0034] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0035] In some embodiments, one or more positioning supports may be optionally configured to transition between a compressed state and an uncompressed state.

[0036] In some embodiments, the frame may be configured to extend between the inlet and outlet ends.

[0037] In some embodiments, the delivery device may be configured to include a handle.

[0038] In some embodiments, the delivery device may be configured to include an inner capsule and an outer capsule.

[0039] In some embodiments, the inner capsule is optionally configured to hold the artificial valve within it in a radially compressed configuration.

[0040] In some embodiments, the outer capsule optionally has an inner diameter larger than the outer diameter of the inner capsule.

[0041] In some embodiments, one or more positioning posts are optionally configured to extend radially away from the frame when deployed.

[0042] In some embodiments, the artificial valve, inner capsule, and outer capsule are axially movable relative to each other.

[0043] In one of the basic configurations, the delivery assembly comprises an artificial valve and a delivery device having one or more positioning arms extending through the lumen of the nose cone shaft of the delivery device. Preferably, this basic configuration may provide one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also provide one or more of the configurations shown in the figures and / or described in conjunction with the figures, preferably as additional or alternative configurations to the configurations of the embodiments described below.

[0044] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0045] In some embodiments, the frame optionally extends between the inlet and outlet ends.

[0046] In some embodiments, the delivery device may be configured to include a handle.

[0047] In some embodiments, the nose cone shaft optionally extends distally from the handle.

[0048] In some embodiments, the delivery device may include a nose cone attached to the distal portion of the nose cone shaft.

[0049] In some embodiments, the nose cone shaft may be configured to include one or more side openings formed in the distal portion of the nose cone shaft.

[0050] In some embodiments, one or more positioning arms are optionally configured to transition between a compressed state and an uncompressed state.

[0051] In some embodiments, one or more positioning arms are optionally movable axially relative to the nose cone shaft and the nose cone.

[0052] In some embodiments, one or more positioning arms are optionally configured to be in a compressed state when fully held within the lumen of the nose cone shaft.

[0053] In some embodiments, one or more positioning arms are optionally configured to take an extended position when at least a portion of them extends through one or more side openings.

[0054] In some embodiments, one or more positioning arms are optionally configured to extend radially away from the nose cone shaft when deployed.

[0055] In one of the basic configurations, the delivery assembly comprises an artificial valve and a delivery device having one or more positioning arms attached to the nose cone of the delivery device. Preferably, this basic configuration may provide one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also provide one or more of the configurations shown in the figures and / or described in conjunction with the figures, preferably as additional or alternative configurations to the configurations of the embodiments described below.

[0056] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0057] In some embodiments, the frame optionally extends between the inlet and outlet ends.

[0058] In some embodiments, the delivery device may be configured to include a handle.

[0059] In some embodiments, the delivery device may be configured to include a nose cone shaft extending distally from the handle.

[0060] In some embodiments, the nose cone is optionally attached to the distal portion of the nose cone shaft at the proximal end of the nose cone.

[0061] In some embodiments, one or more positioning arms may be optionally attached to the nose cone at their fixed ends and optionally extend proximal from there to the free ends of one or more positioning arms.

[0062] In some embodiments, the delivery device may be configured to include one or more tension members attached to the free end of one or more positioning arms and optionally extending proximal therefrom.

[0063] In some embodiments, the nose cone shaft arbitrarily defines the lumen of the nose cone shaft.

[0064] In some embodiments, the nose cone shaft may be configured to include one or more side openings formed in the distal portion of the nose cone shaft.

[0065] In some embodiments, one or more positioning arms are optionally configured to transition between a compressed state and an uncompressed state.

[0066] In some embodiments, one or more positioning arms are optionally configured to be in a compressed state when one or more tension members attached to them are subjected to tension.

[0067] In some embodiments, one or more positioning arms are optionally configured to take an extended position when tension is released from one or more tension members.

[0068] In some embodiments, one or more positioning arms are optionally configured to extend radially away from the nose cone and nose cone shaft when deployed.

[0069] In one of the basic configurations, the delivery assembly comprises a delivery device and an artificial valve having an outer skirt including a circumferential mesh. Preferably, this basic configuration may provide one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also provide one or more of the configurations shown in the figures and / or described in conjunction with the figures, preferably as additional or alternative configurations to the configurations of the embodiments described below.

[0070] In some embodiments, the delivery device may include a capsule.

[0071] In some embodiments, the artificial valve may have a frame that can move between a radially compressed configuration and a radially expanded configuration.

[0072] In some embodiments, the outer skirt is optionally positioned around the frame.

[0073] In some embodiments, the circumferential mesh is optionally configured to transition between a compressed state and an expanded free state.

[0074] In some embodiments, the circumferential mesh is optionally configured to be compressed when the artificial valve is held within the capsule and to be expanded and free when the artificial valve is deployed from the capsule.

[0075] In one of its basic configurations, the artificial valve comprises a frame including multiple struts, including multiple inlet vertical struts. This basic configuration may preferably include one or more of the configurations described elsewhere in this disclosure, in particular the configurations of the embodiments described below. However, it will be understood that the basic configuration may also preferably include one or more of the configurations shown in the figures and / or described in conjunction with the figures, as additional or alternative configurations to the configurations of the embodiments described below.

[0076] In some embodiments, the frame is movable between a radially compressed configuration and a radially expanded configuration as an optional configuration.

[0077] In some embodiments, the frame optionally extends between the inlet and outlet ends.

[0078] In some embodiments, the frame may be configured to include multiple intersecting supports.

[0079] In some embodiments, the multiple supports may be configured to include multiple angled supports and multiple vertical supports.

[0080] In some embodiments, the multiple vertical supports may be configured to include multiple inlet vertical supports.

[0081] In some embodiments, the inlet vertical support is arbitrarily defined between the cells of the frame extending from the inlet end.

[0082] In some embodiments, the multiple vertical supports may be configured to include multiple outflow vertical supports.

[0083] In some embodiments, the outflow vertical support is arbitrarily defined between the cells of the frame extending from the outflow end.

[0084] In some embodiments, the inlet vertical support optionally defines an inlet support length greater than the outlet support length defined by the outlet vertical support.

[0085] In one of the basic methods, the method includes the step of advancing a delivery assembly, which has a delivery device that carries an artificial valve in a radially compressed configuration, onto a natural heart valve. Preferably, this basic method may provide one or more of the steps described elsewhere in this disclosure, in particular the steps of the embodiments described below. However, it will be understood that the basic method may also preferably provide one or more of the steps shown in the figures and / or described in conjunction with the figures as an additional or alternative configuration to the steps of the embodiments described below.

[0086] In some embodiments, the method includes the step of contacting the contact surface of a natural heart valve with at least one positioning member of the delivery device.

[0087] In some embodiments, the method includes the step of identifying the axial position of the annular portion of a natural heart valve by monitoring at least one positioning member under fluorescence imaging.

[0088] In some embodiments, the method includes the step of positioning the inlet end of the artificial valve in an axial position with respect to at least one positioning member, while monitoring both the frame of the artificial valve and at least one positioning member under fluorescence fluoroscopy.

[0089] In some embodiments, the method optionally includes the step of expanding the artificial valve within the annular portion.

[0090] Various aspects of this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, some of the various concepts described later in the detailed description. This summary is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The aforementioned and other objects, structures, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

[0091] Brief explanation of the drawing This specification describes several embodiments of the present invention with reference to the accompanying drawings. This specification, together with the drawings, will make it clear to those skilled in the art how some embodiments may be carried out. The drawings are for illustrative purposes only and do not attempt to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present invention. For clarity, some objects shown in the drawings are not to exact scale.

[0092] The drawing is as follows: [Brief explanation of the drawing]

[0093] [Figure 1A] Figure 1A is a perspective view of an exemplary artificial valve. [Figure 1B] Figure 1B shows a perspective view of the frame in the artificial valve shown in Figure 1A. [Figure 2] Figure 2 shows an exemplary delivery assembly comprising a delivery device for supporting an artificial valve. [Figure 3] Figure 3 shows an exemplary delivery assembly with a positioning member. [Figure 4] Figure 4 shows an exemplary delivery assembly comprising a distally oriented sensor attached to a positioning member. [Figure 5] Figure 5 shows an exemplary delivery assembly with a lateral orientation sensor attached to a positioning member. [Figure 6] Figure 6 shows an exemplary delivery assembly comprising axially spaced sensors attached to a positioning member. [Figure 7] Figure 7 shows an exemplary delivery assembly comprising a first sensor attached to a positioning member and a second sensor attached to another component of the delivery assembly. [Figure 8] Figure 8 shows an exemplary delivery assembly with an inflatable positioning balloon. [Figure 9]Figure 9 shows an exemplary delivery assembly with a stabilization filter. [Figure 10] Figure 10 shows an exemplary delivery assembly with an artificial valve equipped with a positioning support. [Figure 11] Figure 11 shows the distal portion of a delivery device that includes an inner capsule positioned inside an outer capsule. [Figure 12A] Figure 12A shows a portion of the artificial valve positioned within the inner and outer capsules, with the positioning arm held in a compressed state. [Figure 12B] Figure 12B shows the artificial valve of Figure 12A with the positioning arm in a free position. [Figure 13A] Figure 13A shows an exemplary delivery assembly in which the positioning arm is held in a compressed state inside the nose cone shaft. [Figure 13B] Figure 13B shows the delivery assembly of Figure 13A, where the positioning arm extends radially outward through a lateral opening in the nose cone shaft. [Figure 14A] Figure 14A shows an exemplary delivery assembly having a positioning arm that extends proximal to the nose cone and is held in a compressed state by a tensioned member. [Figure 14B] Figure 14B shows the delivery assembly of Figure 14A, where the positioning arm extends radially outward relative to the nose cone, and the tensioning member is released. [Figure 15] Figure 15 shows an exemplary delivery assembly with an outer skirt featuring a circumferential mesh. [Figure 16] Figure 16 shows an exemplary artificial valve frame with an inlet vertical column longer than the outlet vertical column. [Modes for carrying out the invention]

[0094] For the purposes of this specification, specific aspects, advantages, and novel configurations in the examples of this disclosure are described herein. The methods, apparatus, and systems disclosed are not to be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects relating to the various examples disclosed, individually, in various combinations of each other, and in various subcombinations of each other. The methods, apparatus, and systems are not limited to any specific aspects, configurations, or combinations thereof, and the examples disclosed do not require the existence of any one or more specific advantages or problems to be solved. Techniques from any example can be combined with techniques described in any one or more of the other examples. Given the many possible embodiments to which the principles of the disclosed techniques may be applied, it will be recognized that the exemplary examples are merely preferred embodiments and should not be considered to limit the scope of the disclosed techniques.

[0095] While some operations of the disclosed embodiments are described in a specific sequential order for the sake of presentation, it will be understood that this aspect of the description is inclusive of reordering unless a specific order is required by the specific wording described below. For example, operations described sequentially may be reordered and performed simultaneously in some cases. Furthermore, for the sake of simplification, the accompanying drawings may not show various ways in which the disclosed method can be used in combination with other methods. In addition, the description sometimes uses terms such as “provide / prepare” or “achieve” to describe the disclosed method. These terms are high-level abstractions of the actual work performed. The actual work corresponding to these terms may be modified as appropriate depending on the specific implementation and will be readily apparent to those skilled in the art.

[0096] All configurations described herein are independent of each other and can be used in combination with any other configuration described herein, unless structurally impossible.

[0097] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural form unless the context clearly specifies otherwise. Furthermore, the terms “have” or “includes” mean “comprises.” In addition, as used in this disclosure, the terms “coupled,” “connected,” or “attached” generally mean interchangeable and coupled or linked physically, mechanically, chemically, magnetically, and / or electrically, and do not preclude the presence of intermediate elements between coupled or associated members unless otherwise specified. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0098] In this disclosure, directions and other relative references may be used to facilitate the explanation of drawings and principles, but these are not intended to be limiting. For example, specific terms such as “inside,” “outside,” “top,” “bottom,” “internal,” “external,” “top,” “bottom,” “inside,” “outside,” “left,” “right,” and similar terms may be used. Such terms are used where applicable to clarify the explanation to some extent when dealing with relative relationships, particularly with respect to the illustrated examples. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, the “top” portion can become the “bottom” portion simply by inverting the object. Nevertheless, the portion remains the same, and the object remains the same.

[0099] When used with elements, the terms “plurality” or “multiple” mean two or more elements. Directions and other relative references (e.g., inside and outside, top and bottom, upward and downward, left and right, and proximal and distal) may be used to facilitate the discussion of the drawings and principles herein, but are not intended to be limiting.

[0100] The terms “proximal” and “distal” are defined in relation to the location of use of the delivery device. Generally, the end of the delivery device closest to the user of the device is the proximal end, and the end of the delivery device furthest from the user (e.g., the end inserted into the patient's body) is the distal end. When used in reference to two spatially separated locations or parts of an object, the term “proximal” may be understood to mean closer to or oriented toward the proximal end of the delivery device. When used in reference to two spatially separated locations or parts of an object, the term “distal” may be understood to mean closer to or oriented toward the distal end of the delivery device. The terms “longitudinal” and “axial” are interchangeable and refer to axes extending in the proximal and distal directions, respectively, unless otherwise explicitly defined.

[0101] The terms “axial,” “radial,” and “circumferential,” as used in this disclosure, are used to describe the arrangement and assembly of components with respect to the geometry of the frame of the artificial heart valve. Such terms are used for illustrative purposes only and do not strictly limit the examples disclosed. Specifically, when a component or function is described with respect to a particular direction, this includes directions parallel to the specified direction and slight deviations therefrom. Thus, a description of a component extending along the axial direction of the frame does not require the component to be aligned with the center of the frame; rather, the component may extend substantially along a direction parallel to the central axis of the frame.

[0102] As used herein, the terms “integrally formed” and “single structure” refer to a structure that does not involve any welding, fasteners, or other means for fastening separately formed material pieces together.

[0103] As used herein, actions occurring "simultaneously" or "concurrently" occur simultaneously with each other as a whole, but any delay in the occurrence of the other action, such as that caused by the spacing between components, is explicitly within the scope of the above term unless otherwise stated.

[0104] Where used in this disclosure, terms such as “first,” “second,” etc., are intended to function as labels for distinct components, steps, etc., and are not intended to imply or suggest any particular order or priority. For example, unless otherwise stated, a step performing a second operation and / or forming a second component may be performed before a step performing a first operation and / or forming a first component.

[0105] Where used in this disclosure, the term “substantially” means any enumerated value and / or characteristic, as well as any value and / or characteristic that is at least 75% of the enumerated value and / or characteristic. Equivalently, the term “substantially” means any enumerated value and / or characteristic, as well as any value and / or characteristic that is up to 25% different from the enumerated value and / or characteristic. For example, “at least substantially parallel” means perfectly parallel directions and directions that are offset by up to 22.5 degrees.

[0106] In this disclosure, reference codes including alphabetical labels (e.g., "a", "b", "c", etc.) will be understood as identifying specific examples in the structure or component to which the reference code corresponds. Accordingly, it will be understood that components sharing similar names and / or similar reference codes may share any characteristics and / or features disclosed in this disclosure, even if a particular such component is not specifically described and / or referred to in this disclosure.

[0107] Throughout the drawings, different examples of the same component are shown by using different superscripts for the same reference numeral. The examples of devices and systems disclosed may include any combination of different examples of the same component. Specifically, any reference to a component that does not have a superscript may refer to any alternative example of the same component indicated by the superscript. To avoid unnecessary confusion from having an excessive number of reference numerals and leader lines on a particular drawing, some components are introduced through one or more drawings and are not explicitly identified in any subsequent drawings that contain that component.

[0108] Figures 1A and 1B show perspective views of the artificial valve 100 with and without soft components attached, according to some embodiments. Figure 2 shows a perspective view of the delivery assembly 200, according to some embodiments. The delivery assembly 200 may include the artificial valve 100 and a delivery device 202. Optionally, the artificial valve 100 may be mounted on the delivery device 202, or detachably connected to the delivery device 202. Optionally, the delivery device may have a handle 204 at its proximal end, a nose cone 236 attached to its distal end, and a nose cone shaft 220 (hidden from view in Figure 2, but exposed in, for example, Figure 3) extending distally from the handle 204.

[0109] As used in this disclosure, the term “artificial valve” refers to any type of artificial valve that can be delivered to a target site in a patient via a catheter, and which is radially expandable and radially compressible between a radially compressed or crimped state and a radially expanded state. Thus, the artificial valve 100 can be crimped or held in a compressed state by the delivery device 202 during delivery, and thereafter, upon reaching the implantation site, the artificial valve 100 can expand to an expanded state. Optionally, the expanded state may include a diameter range to which the valve can expand, between the compressed state and the maximum diameter reached in the fully expanded state. Thus, the partially expanded states may relate to any expansion diameter between the radially compressed state and the fully expanded state.

[0110] The artificial valve 100 of this disclosure may include any artificial valve configured to be installed inside a natural aortic valve, natural mitral valve, natural pulmonary valve, and natural tricuspid valve. The delivery assembly 200 described in this disclosure includes a delivery device 202 and a balloon-inflatable prosthesis such as the artificial valve 100, but it will be understood that the delivery device 202 in any embodiment of this disclosure may be used for the implantation of other prostheses other than artificial valves, such as stents or grafts.

[0111] As an optional configuration, a catheter-deliverable prosthetic valve 100 can be delivered to the implantation site via a delivery assembly that carries the valve 100 toward a target site to be implanted relative to a natural anatomical target site by expanding the prosthetic valve 100 via various expansion mechanisms in a radially compressed or crimped state. A balloon-inflatable valve generally includes a procedure to inflate a balloon within the prosthetic valve, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is fully expanded, the balloon is deflated and retrieved together with the delivery device 202. A self-expandable valve includes a frame shaped to automatically expand as soon as an outer retaining capsule, which may also be defined as the distal portion of the outer shaft or the distal portion of the delivery shaft, is withdrawn proximally relative to the prosthetic valve.

[0112] Mechanically expandable valves are a category of artificial valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism typically includes multiple expansion lock assemblies (such as the artificial valves described in Patent Documents 1-4, each of which is incorporated herein by reference), and the expansion lock assemblies are detachably coupled to their respective drive assemblies in the delivery device and are controlled via handles to drive the expansion and lock assemblies, thereby expanding the artificial valve to a desired diameter. The expansion lock assemblies may optionally lock the valve diameter to prevent undesirable recompression of the valve, and may also allow the delivery device to be retrieved after the artificial valve has been properly positioned at the desired implantation site by detaching the drive assemblies from the expansion lock assemblies.

[0113] The delivery assembly can be used, for example, to deliver an artificial aortic valve for placement on an aortic annulus, to deliver an artificial mitral valve for placement on a mitral annulus, or to deliver an artificial valve for placement on any other natural valve annulus.

[0114] Figures 1A and 1B show embodiments of the artificial valve 100, which can be a balloon-inflatable valve as an optional configuration, and are illustrated in an expanded state. The artificial valve 100 has an outlet end 104, an inlet end 106, and a central longitudinal axis Ca extending from the inlet end 106 to the outlet end 104. In some cases, the outlet end 104 is the proximal end of the artificial valve 100, and the inlet end 106 is the distal end of the artificial valve 100. In other configurations, for example, depending on the valve delivery approach, the outlet end can be the distal end of the artificial valve, and the inlet end can be the distal end of the proximal valve.

[0115] As used in this disclosure, the term “outflow” refers to the region of the artificial valve through which blood flows and out of the artificial valve 100.

[0116] As used in this disclosure, the term “inflow” refers to the region of the artificial valve into which blood flows and is introduced.

[0117] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. For example, the lower end of the artificial valve is its inflow end, and the upper end of the artificial valve is its outflow end.

[0118] In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “distal” and “proximal,” respectively. Therefore, for example, the lowest component may refer to the most distal component, and the uppermost component may similarly refer to the nearest component.

[0119] The artificial valve 100 comprises an annular frame 102 that is movable between a radially compressed structure and a radially expanded structure, and a valve leaflet assembly 126 mounted within the frame 102. The frame 102 can be made from a variety of suitable materials, including, but not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys such as MP35N alloy), polymers, or combinations thereof. When made from a plastically deformable material, the frame 102 can be crimped into a radially compressed state on the balloon catheter 210 and then expanded in the patient's body by an expandable balloon 212 or an equivalent expansion mechanism. As an alternative or additional configuration, the frame 102 can be made from a shape memory material, such as nickel-titanium alloy (e.g., Nitinol), but not limited to. When constructed from a shape memory material, the frame 102 can be crumpled into a radially compressed state and can also be constrained in a compressed state by being inserted into the shaft of the delivery device 202 or an equivalent mechanism.

[0120] In the embodiments shown in Figures 1A and 1B, the frame 102 is an annular stent-like structure including a plurality of intersecting supports 108. In this application, the term “support” encompasses axial supports, angled supports, laterally expandable supports, intersecting windows, intersecting support supports, support posts, and any similar structures described in Patent Documents 5 and 6, which are incorporated herein by reference. The supports 108 may be any elongated members or elongated portions of the frame 102. The frame 102 may include a plurality of rows of supports that can collectively define one or more rows of cells 118. The frame 102 may have a cylindrical or substantially cylindrical shape with a constant diameter from the inlet end 106 to the outlet end 104, as shown, or the frame may have a diameter that changes along the height of the frame, as disclosed in Patent Document 7, which is incorporated herein by reference.

[0121] The end portion of the support column 108 forms a vertex 122 at the outflow end 104 and a vertex 124 at the inflow end 106. The support column 108 can intersect at an additional joint 120 formed between the outflow side vertex 122 and the inflow side vertex 124. The joint 120 may be configured to be evenly or unevenly spaced apart from each other and / or from the vertices 122 and 124 between the outflow end 104 and the inflow end 106.

[0122] At least some of the multiple support columns 108 may be rotatable or bendable relative to each other to allow the frame to expand and contract. For example, the frame 102 may be formed from a single material member, such as a metal tube, through various processes such as laser cutting, electroforming, and / or physical deposition, and may retain the ability to compress / expand radially without hinges and similar components.

[0123] As an optional configuration, the leaflet assembly 126 of the artificial valve 100 includes a plurality of artificial leaflets 128 (e.g., three leaflets) at least partially located inside the frame 102, and is configured to regulate the blood flow through the artificial valve 100 from the inlet end 106 to the outlet end 104. Although the example illustrated in Figure 1A shows three leaflets 128 arranged to be compressed in a tricuspid configuration, it will be clear that the artificial valve 100 may be configured to include any other number of leaflets 128.

[0124] As an optional configuration, the inlet or cusp edge of the valve leaflet 128 may be directly or indirectly fixed to the frame 102, such as by being directly sutured to the frame, sutured to an inner skirt, and / or via one or more connecting skirts. Further embodiments and methods for attaching skirts and sealing members to the frame, as well as methods and techniques for joining the valve leaflet 128 to the frame 102 with or without connecting skirts, are disclosed in Patent Document 8, incorporated herein by reference.

[0125] As an optional configuration, adjacent valve leaflets 128 can be placed together to form joints 134 that are (directly or indirectly) connected to corresponding portions of the frame 102, thereby fixing at least a portion of the valve leaflet assembly 126 to the frame 102. As an optional configuration, in some embodiments, each valve leaflet 128 may be configured to have optionally opposing tabs 130. As an optional configuration, each tab 130 can be fixed to the adjacent tab 130 of an adjacent valve leaflet 128, thereby forming joints 134 that are fixed to the frame 102. The tabs 130 can be folded in various ways, for example, to form radially extending layers and circumferentially extending layers facing the frame. The radially extending layers may be configured to extend radially inward from their position on the frame 102 to a free edge 132, also called the joint edge of the valve leaflet.

[0126] During valve cycling, the valve leaflets 128 can articulate at the innermost edge of the tab layer, thereby assisting in separating the valve leaflets from the frame 102 during normal operation of the prosthetic valve. This may be particularly advantageous when the prosthetic valve 100 does not fully expand to its nominal size when implanted in a patient. Thus, the prosthetic valve 100 can be implanted within a wider range of annular sizes in the patient. Further details regarding transcatheter prosthetic valves, including embodiments in which the valve leaflets 128 can be coupled to the frame 102 of the prosthetic valve 100, can be found, for example, in Patent Documents 5 and 9-13, all of which are incorporated herein by reference in their entirety.

[0127] As an optional configuration, according to some embodiments, the artificial valve 100 may further include at least one skirt or sealing member. The inner skirt 136 can be fixed to the inner surface of the frame 102 and is configured to function as a sealing member for preventing or reducing, for example, perivalve leakage. Furthermore, the inner skirt 136 may be configured to function as an anchoring area for fixing the valve leaflet 128 to the frame 102 and / or to function to protect the valve leaflet 128 from damage that may be caused by contact with the frame 102, for example, during valve compression or during the operating cycle of the artificial valve 100. As an additional or alternative configuration, the artificial valve 100 may include an outer skirt 140 mounted on the outer surface of the frame 102, the outer skirt 140 being configured to function as a sealing member held between, for example, the frame 102 and the surrounding tissue of the natural valve ring to which the artificial valve will be mounted, thereby reducing the risk of perivalve leakage (PVL) passing through the artificial valve 100.

[0128] The outer skirt 140 may optionally include a base layer 146 extending from the outer skirt inlet end 144 to the outer skirt outlet end 142. Either the inner skirt 136 and / or the base layer 146 of the outer skirt 140 can be made from a variety of suitable biocompatible materials, such as various synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue), but are not limited to these. In some cases, the inner skirt 136 may be formed from a single sheet material extending continuously around the inner surface of the frame 102, as an optional configuration. In some embodiments, the optional outer skirt 140 or its base layer 146 may be formed from a single sheet material extending continuously around the outer surface of the frame 102.

[0129] The support columns 108 include inclined support columns 110 and optionally include vertical support columns 112. The term “vertical support column” generally refers to a support column that extends in a direction perpendicular to the central longitudinal axis Ca, while the term “inclined support column” generally refers to a support column that may extend inclined with respect to an axis intersecting itself along the plane defined by the frame 102. It will be understood that the term “inclined support column” encompasses both straight and curved inclined support columns.

[0130] Figure 1B shows an example of a frame 102 that includes at least two types of vertical supports 112, namely, an outflow-side vertical support 114 defined between a plurality of cells 118 extending from the outflow end 104, and an inflow-side vertical support 116 defined between a plurality of cells 118 extending from the inflow end 106. As shown, the cells 118 extending from the inflow end 106 and from the outflow end 104 may, in some embodiments, optionally define hexagonal openings therein, and the frame may optionally further include at least one additional row of diamond-shaped cells between them.

[0131] Various exemplary embodiments relating to the artificial valve 100, the delivery assembly 200, and / or its components may be referenced by superscripts throughout this specification to facilitate the description of features referring to such exemplary implementations. However, it will be understood that any reference without superscripts to any structural or functional configuration of any assembly device or component refers to a configuration that is commonly shared by all specific exemplary embodiments, which may also be indicated by superscripts. In contrast, with respect to exemplary implementations of any assembly, device, or component such as the artificial valve 100 and / or the delivery assembly 200, configurations highlighted by superscript references may, at their discretion, be shared by some of all other exemplary embodiments, but not necessarily by all other exemplary embodiments. For example, artificial valve 100 aThis is an exemplary implementation of the artificial valve 100 and therefore includes all the configurations described for the artificial valve 100 throughout this disclosure, except that the artificial valve 100 may generally be provided with any type of strut 108, such as angled struts and / or vertical struts 112 of any shape and size. a The system includes an outflow vertical support 114 having an outflow vertical support length Lov and an inflow vertical support 116 having an inflow vertical support length Liv, wherein the length Lov of the outflow vertical support 114 is greater than the length Liv of the inflow vertical support 116 (i.e., Lov > Liv).

[0132] While several embodiments of the delivery assemblies described herein are illustrated to include a delivery device and a balloon-inflatable artificial valve, it will be understood that a delivery device according to any embodiment of the herein may be used for the implantation of other prosthetic devices other than artificial valves, such as stents or grafts.

[0133] A delivery assembly comprising any delivery device described throughout this disclosure may be used, for example, to deliver an artificial molar flap to the natural molar ring or to an artificial flap previously implanted in a natural molar flap; to deliver an artificial mitral flap to the natural mitral ring or to an artificial flap previously implanted in a natural mitral flap; or to deliver an artificial flap to any other natural annular portion or to an artificial flap previously implanted in any other natural flap.

[0134] Figure 2 illustrates a delivery assembly 200 of a delivery device 202 adapted to deliver an artificial valve, such as the artificial valve 100 described above with respect to Figures 1A-1B. According to some embodiments, the delivery device 202 includes a handle 204 and at least one catheter extending therefrom, and is configured to deliver the artificial valve 100 in a crimped state through the patient's vascular structure. As an optional configuration, an exemplary delivery assembly 200 aThis is an exemplary delivery device 202 configured to deliver a balloon-inflatable artificial valve. a It includes the following optional configuration: delivery device 202 a The configuration may include a balloon catheter 210 having an inflatable balloon 212 mounted on its distal end. As an optional configuration, the balloon-inflatable artificial valve 100 may be supported in a crimped state on the balloon catheter 210.

[0135] In some embodiments, the delivery device 202 further comprises an outer delivery shaft 208. Optionally, the delivery device 202 a The outer delivery shaft 208 may be configured to extend concentrically over the balloon catheter 210. In some embodiments, the delivery device 202 a The configuration may optionally include a push shaft 214 positioned above the balloon catheter 210, and optionally further provided between the balloon catheter 210 and the outer delivery shaft 208.

[0136] As an optional configuration, the outer delivery shaft 208, the push shaft 214, and the balloon catheter 210 may be configured to be axially movable relative to each other. For example, the artificial valve 100 can be exposed from the outer delivery shaft 208 by proximal movement of the outer delivery shaft 208 relative to the balloon catheter 210, or by distal movement of the balloon catheter 210 relative to the outer delivery shaft 208.

[0137] The delivery device 202 may optionally further include a nose cone 236 held by a nose cone shaft 220 (not shown in Figure 2, but shown, for example, in any of Figures 3 to 10). a In this case, the nose cone shaft 220 may be configured to extend voluntarily through the lumen of the balloon catheter 210.

[0138] As an optional configuration, the balloon catheter 210, the outer delivery shaft 208, the push shaft 214, and / or the nose cone shaft 220 can be coupled to the handle 204. When delivering the artificial valve 100, the handle 204 is operated by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery device 202, such as the nose cone shaft 220, the outer delivery shaft 208, and in the case of the balloon catheter 210 and / or the push shaft 214, through the patient's vasculature. Also, the artificial valve 100 can be expanded by inflating the balloon 212 mounted on the balloon catheter 210, and after the artificial valve 100 is installed at the implantation site, the balloon 212 can be deflated and the delivery device 202 can be retracted. a In the case of ,

[0139] , , components of the delivery device 202, such as the balloon catheter 210 and / or the push shaft 214, can be driven axially forward or backward through the patient's vasculature. Also, the artificial valve 100 can be expanded by inflating the balloon 212 mounted on the balloon catheter 210, and after the artificial valve 100 is installed at the implantation site, the balloon 212 can be deflated and the delivery device 202 can be retracted.

[0139] As an optional configuration, the handle 204 may be configured to include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 202. In the illustrated example, the handle 204 includes an adjustment member such as the rotatable knob 206a shown, and this adjustment member is operably coupled to the proximal end portion of a tension wire (not shown). The tension wire can extend distally from the handle 204 through the outer delivery shaft 208 and has a distal end portion fixed to or near the distal end of the outer delivery shaft 208. By rotationally driving the knob 206a, the tension of the tension wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 202. Further details regarding the steering mechanism or bending mechanism of the delivery device can be found in Patent Document 14, which is incorporated herein by reference. The handle 204 can further include an adjustment mechanism including an adjustment member such as the rotatable knob 206b shown. The adjustment mechanism is for the delivery device 202 aIn this case, the push shaft 214 can be configured to adjust the axial position of the balloon catheter 210. The handle may also be configured to include an additional knob for controlling additional components of the delivery device 202, such as positioning members, which will be described in more detail below.

[0140] The artificial valve 100 may be carried by the delivery device 202 during delivery in a crimped state, and may be expanded, for example, by balloon inflation to be fixed into a natural heart valve ring (such as the molar ring 24 shown in Figure 3) or to a previously implanted artificial valve (for example, during an intravalvular valve implantation procedure). a In an exemplary implantation procedure using the device, the prosthetic valve 100 is first compressed on the balloon catheter 210 at a position proximal to the inflatable balloon 212. Because the prosthetic valve 100 is crimped at a different position than the balloon 212, it can be crimped to a smaller profile compared to the profile possible if it were crimped on the top of the balloon 212. This smaller profile allows the clinician to... a The compressed prosthetic valve (including the 100) can be more easily maneuvered through the patient's vascular system to the treatment site. The small profile of the compressed prosthetic valve is particularly useful when maneuvering it through particularly narrow sections of the patient's vascular system, such as the iliac artery.

[0141] As an optional configuration, the balloon 212 may be fixed to the balloon catheter 210 at its proximal end, or to the balloon catheter 210, the nose cone shaft 220, or the nose cone 236 at its distal end. The distal end portion of the push shaft 214 is positioned proximal to the outflow end 104 of the artificial valve 100.

[0142] Upon reaching the implantation site, the inflatable balloon 212, carrying the crimped valve 100, can be advanced to the target site to inflate the prosthetic valve. Prior to the inflation of the balloon 212, the push shaft 214 is advanced distally, and its distal end portion contacts and pushes the outflow end 104 of the prosthetic valve 100, thereby pushing the valve 100 distally. The distal end of the push shaft 214 is dimensioned to engage with the outflow end 104 of the prosthetic valve 100 in the crimped configuration of the valve. As an optional configuration, in some embodiments, the distal end portion of the push shaft 214 may be radially flared outward, terminating with a wider diameter that can contact the prosthetic valve 100 in its crimped state. In an optional configuration, the push shaft 214 may then be driven distally forward, pushing the crimped prosthetic valve 100 together with it until the balloon 212 is positioned around the balloon 212, where the balloon 212 can be inflated to radially expand the prosthetic valve 100. Once the prosthetic valve 100 has expanded to its functional diameter within the natural valve annulus or within a previously implanted prosthetic valve, the balloon 212 may be deflated, and the delivery device 202 may be retrieved from the patient's body.

[0143] In certain embodiments, any exemplary delivery assemblies of this disclosure may be optionally packaged in sterile packages that can be supplied to the end user for storage and final use. In certain embodiments, the leaflets of the prosthetic valve (typically made from bovine pericardial tissue, or other natural or synthetic tissue) are completely or substantially dehydrated by processing during the manufacturing process, thereby allowing them to be stored in a partially or fully compressed state without a humidifying solution. Thus, the package containing the delivery assembly may not contain any liquid. Methods for processing tissue leaflets for dry storage are disclosed in Patent Documents 15 and 16, both of which are incorporated herein by reference.

[0144] As stated above, the specific methods described and illustrated herein address the replacement of molar valves, but any exemplary delivery assemblies 200 described throughout this disclosure can be used to assist in the precise positioning and deployment of implants to all heart valves, and can also be used to assist in the precise positioning and deployment of implants to other orifices and body cavities, such as major arteries and veins associated with the heart (including, but not limited to, the superior and inferior vena cava, as well as the pulmonary artery and vein, coronary sinus, nominate artery, common carotid artery, and subclavian artery).

[0145] Figure 3 shows an exemplary delivery assembly 200 used to position the artificial valve 100 within the natural annular portion 24. b The delivery assembly 200 can optionally advance into the patient via the femoral artery (not shown), and then advance through the molars 26 and molar roots 28 toward the molar valve 20. In some embodiments, the distal portion of the delivery assembly 200 can optionally advance further into the left ventricle 32, such as through the annular portion 24 and natural leaflets 22 of the aortic valve 20, as shown in Figure 3, within the left ventricular outflow duct (LVOT) 34 of the left ventricle 32.

[0146] As described above, proper positioning of the prosthetic valve 100 can advantageously ensure the success of valve implantation within the natural heart valve annulus. An example of a delivery assembly 200 disclosed herein is a delivery device 202 and / or prosthetic valve 100 equipped with positioning and / or stabilizing components that can be used during placement of the prosthetic valve and implantation within the natural heart valve.

[0147] Delivery Assembly 200 b This is an exemplary implementation of the delivery assembly 200, and therefore the delivery device 202 of the delivery assembly 200b. bExcept for further comprising at least one elongated positioning member 250 extending distally from the handle 204, the delivery assembly 200 includes all the configurations described throughout this disclosure. The elongated positioning member 250 extends through the lumen of the outer delivery shaft 208, etc., of the delivery device 202 b The configuration may extend through the shaft or catheter.

[0148] In some embodiments, the delivery assembly 200 b The delivery device 202 can be optionally configured for the delivery of the balloon expandable valve. b is the delivery device 202 a This can be implemented according to any of the embodiments described above. In some embodiments, the elongated positioning member 250 may be configured to extend optionally through the space formed between the balloon catheter 210 and the outer delivery shaft 208, as shown in Figure 3.

[0149] The positioning member 250 can optionally be configured to be a delivery device 200 such as an outer delivery shaft 208 or any other shaft. b The positioning member 250 may be independently operated through the sheath or catheter and may extend from the shaft (e.g., from the outer delivery shaft 208) via, for example, the movement of the handle 204 by a clinician. Although the positioning member 250 is illustrated to extend from the outer delivery shaft 208, in some embodiments the delivery device may optionally include a plurality of shafts that can be arranged adjacent to one another within the same sheath. Accordingly, any reference to any type of positioning member that can extend through the outer delivery shaft 208 as disclosed herein should be understood to also refer to positioning members that extend through any other sheath of the shafts of the delivery device.

[0150] The positioning member 250 may, as an optional configuration, be axially movable relative to the artificial valve 100, the outer delivery shaft 208, and / or other components of the delivery assembly 200, such as the balloon catheter 210. As an optional configuration, the handle 204 may include a mechanism (not shown) that controls the axial movement of the elongated positioning member 250. Although a single elongated positioning member 250 is illustrated in Figure 3, it should be understood that any other number is contemplated, including any multiple two or more elongated positioning members 250 spaced circumferentially apart from one another around the artificial valve 100.

[0151] The natural valve 20 may define a proximal contact surface 36, which is defined as the proximal surface of the natural valve 20, and may be formed by the cusps or proximal portion of the natural leaf 22 extending from the annular portion 24. Optionally, the elongated positioning member 250 may extend from the distal end of the outer delivery shaft 208 and interact with the contact surface in the implantation region to guide the placement and positioning of the prosthetic valve 100 within the host valve (e.g., the natural aortic valve). For example, the elongated positioning member 250 can optionally advance to contact and rest on the proximal contact surface 36 of the natural heart valve 20, assisting in the precise positioning of the prosthetic valve 100. Optionally, the elongated positioning member 250 may be configured to be axially movable distal to the outer delivery shaft 208, and optionally, its distal portion may advance so as to radially move away from the outer delivery shaft 208 and / or the prosthetic valve 100.

[0152] In some embodiments, the distal end 254 of the elongated positioning member 250 is configured to be non-traumatic (e.g., blunt or lacking otherwise sharp edges) to avoid damage to surrounding anatomical structures during operation. For example, the elongated positioning member 250 may optionally have a contoured distal end 254 having a circular, elliptical (e.g., spoon-shaped), C-shaped, J-shaped, or any other arched shape to increase the contact area between the distal end 254 and the contact surface 36 (e.g., cusp portion). In some embodiments, as an optional configuration, the elongated positioning member 250 may be formed from a plurality of wires, for example, as a pair of wires bent laterally to contact or attach to each other at the distal end 254. In some embodiments, the elongated positioning member includes a catheter or sheath having a non-traumatic distal end (examples not shown).

[0153] In some embodiments, the elongated positioning member 250 is provided with a loop 252 at its distal end. The loop 252 can optionally define inclined side segments 256 and a bottom-curved segment 254 between them. Advancement of the elongated positioning member 250 may be carried out in an optional configuration such that the bottom-curved segment 254 is pressed against the proximal contact surface 36. In some embodiments, the elongated positioning member 250 may optionally be a pre-formed wire or cable, such as a wire formed from a shape-memory material such as Nitinol. Thus, the elongated positioning member 250 advancing from the outer delivery shaft 208 can have its ends, such as the loop 252, adopt a predetermined shape. In some embodiments, the elongated positioning member 250 may optionally be formed from other materials such as metal (e.g., steel, titanium, etc.), metal alloy (e.g., cobalt-chromium alloy, etc.), plastic, or any combination thereof.

[0154] The delivery assembly 200 can optionally advance from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. The elongated positioning member 250 can optionally be retained within the outer delivery shaft 208 before reaching the implantation site. Once one or more elongated positioning members 250 reach the aortic valve 20, they can optionally advance from the distal end of the outer delivery shaft 208 toward the proximal contact surface 36 (e.g., the cusp of the natural valve leaflet 22), but can also optionally move away from the proximal contact surface 36. Simultaneously with or in conjunction therewith the advancement of the elongated positioning member 250 (e.g., anterior-posterior), the artificial valve 100 can optionally advance from the distal end of the outer delivery shaft 208 toward and through the natural molar ring 24, as shown in Figure 3, together with, for example, the balloon catheter 210. The forward movement of the elongated positioning member 250 can be optionally continued until the elongated positioning member 250 reaches the proximal contact surface 36.

[0155] Using tactile feedback from an elongated positioning member 250, created by contact between its distal end, such as the bottom curved segment 254, and the proximal contact surface 36, a clinician can confirm the position of the natural annular region where the prosthetic valve 100 can be properly positioned. Conventional techniques for positioning the prosthetic valve inside the natural annular region include injecting a contrast agent into the implantation area to visualized anatomical structures that are otherwise not visible under fluoroscopy. By utilizing the exemplary positioning members disclosed herein, it is possible to provide an annular-level visual indication that allows the prosthetic valve 100 to be manipulated and positioned relative to it without the need to introduce a contrast medium into the bloodstream.

[0156] The exemplary positioning members disclosed herein are visible under X-ray, and as a result, once contact with the natural annular portion is identified, the artificial valve 100 can be moved axially relative to the position of the corresponding positioning member, indicating a desired position of the artificial valve 100 relative to the natural annular portion 24. For example, as described above, tactile feedback from the elongated positioning member 250 can provide indication of contact with the proximal contact surface 36. Since the elongated positioning member 250 may optionally be formed of a metal wire or other radiopaque material, the position of the bottom curved segment 254, which is visible under fluorescence radiography, can indicate the position of the natural annular portion 24, such as its proximal contact surface 36. The frame 102 of the artificial valve 100 is constructed to include a metallic material that is visible under fluoroscopy, and without the need to inject a contrast agent, such as barium or other types of contrast agents, into the patient's bloodstream during treatment, the position of the frame 102 and bottom curved segment 252 of the loop 252 can be tracked in real time under an appropriate imaging modality such as fluoroscopy, allowing the inlet end 106 to be advanced relative to the annular portion 24 to be positioned in the desired location, thereby increasing procedural safety and reducing material costs.

[0157] If the positioning arm according to any embodiment disclosed herein is configured to contact a specific surface or region of the annular portion 24, further anatomical features can be grasped during the positioning of the artificial valve. For example, if a positioning member such as an elongated positioning member 250 is configured to contact the proximal contact surface 36, the thickness of the natural annular portion 24 can be grasped if the positioning of the valve 100 is desired relative to the distal contact surface 38 or to the center of the natural annular portion 24.

[0158] When the artificial valve 100 is positioned in the desired location, the imaged portion of the positioning member 250 corresponds to the natural annular portion 24, and the clinician can optionally inflate the expansion balloon 212 or inflate it in another way (e.g., via removal of a suppressor sheath or capsule in the case of a self-inflating valve, or by operating a mechanical actuator in the case of a mechanically expandable valve) to expand / position the artificial valve 100 to the desired location within the natural annular portion 24. During expansion of the artificial valve, the elongated positioning member 250 can optionally remain engaged with the proximal contact surface 36 (e.g., pressed against) and optionally absorb at least some of the force applied to the molar valve 20 by the delivery assembly 200 during the implantation procedure.

[0159] In some embodiments, before the full expansion of the artificial valve 100, the elongated positioning member 250 can be optionally retracted from the molar root 28, thereby allowing the artificial valve 100 to fully expand against the inner wall 30 of the molar root 28. The elongated positioning member 250 can be optionally (but not necessarily) retracted into the outer delivery shaft 208, and the balloon 212 (if used) can be deflated to a smaller diameter, and the catheter delivery device 202 b The artificial valve 100 can then be removed from the patient and implanted into the natural valve 20.

[0160] It should be understood that clinicians may rely on additional positioning techniques such as fluoroscopy and echocardiography. For example, during the initial advancement of the delivery assembly 200 into the heart, clinicians may use fluoroscopy, echocardiography, and / or other imaging methods to provide visual confirmation of the orientation and position of components of the delivery assembly 200, such as the prosthetic valve 100 and / or positioning element 250, relative to the natural annular portion 24 or other anatomical regions of interest. Clinicians may also use fluoroscopy, echocardiography, and / or other imaging methods to provide visual confirmation of the orientation and position of various components of the delivery assembly, in addition to the tactile feedback provided by the positioning member, during the positioning of the valve 100 described herein, for example, using the positioning member or other positioning or stabilizing components and devices. Thus, tactile feedback provides clinicians with another important sensory cue for the relative position of the positioning member / prosthetic valve to the annulus.

[0161] In some embodiments, the elongated positioning member 250 may be relatively prominent under applicable image-guided modalities such as fluoroscopy, echocardiography, and / or other imaging methods. As described above, in some embodiments, the elongated positioning member 250 can be fabricated at will from a shape-memory material such as nitinol. Since nitinol is sometimes difficult to see under radiography, radiopaque markers (such as gold) can be added, or nitinol can be mixed with a radiopaque material to be easily identified under radiography during the procedure. Therefore, in some embodiments, the elongated positioning member 250 is fabricated from a radiopaque material or includes a radiopaque marker. This can, in some cases, help in identifying contact between the elongated positioning member 250 and the contact surface 36. For example, when using fluoroscopy or other suitable imaging techniques, the clinician can observe that when the proximal contact surface 36 engages with (i.e., is pressed against) the distal portion of the elongated positioning member 250, such as the loop 252 and / or its bottom curved segment 254, begins to buckle, bend, or deform in shape. Thus, contact with the elongated positioning member 250 can be identified by tactile feedback and / or visually from fluoroscopy or other imaging guidance.

[0162] Figure 4 shows an exemplary delivery assembly 200. c This shows the delivery assembly 200. c This is an exemplary implementation of the delivery assembly 200 and the delivery device 202 c However, the delivery assembly 200b may be similar to any embodiment described above with respect to the at least one elongated positioning member 250, except that it further comprises at least one sensor 258 attached to the elongated positioning member 250, the sensor being oriented distally (i.e., facing a surface that can be substantially perpendicular to the longitudinal axis defined by the elongated positioning member), and configured to contact the proximal contact surface 36 when the elongated positioning member 250 is pressed against the surface 36. bAs mentioned above, two or more elongated positioning members 250 are similarly provided in the delivery device 202 c The configuration may include the following: Delivery device 202 c If the system includes multiple elongated positioning members 250, one, some, or all of the positioning members 250 may optionally include one or more sensors 258 attached thereto.

[0163] In some embodiments, the sensor 258 is a force sensor configured to provide feedback on the force applied by the elongated positioning member 250 on the surrounding anatomical structure. The sensor 258 may optionally be mounted on the distal end of the elongated positioning member 250. In some embodiments, if the elongated positioning member 250 includes a loop 252, the force sensor 258 is mounted on the bottom curved segment 254 and configured to provide feedback on the force applied by the loop 252 of the positioning member 250 on the proximal contact surface 36.

[0164] In some applications, the delivery device 202 c The configuration may include one or more optional communication devices, a sensor data unit (not shown), and one or more user output devices (not shown). As used herein, the term communication device means any device that enables communication through it passively and / or actively. In some embodiments, this includes wires, optical fibers, or wireless communication terminals. The communication device may be configured to enable electrical communication (e.g., via conductive materials such as wires) and / or optical communication (e.g., via optical fibers).

[0165] The communication device may optionally be implemented as an insulated wire extending from the sensor 258, such as along the length of the elongated positioning member and optionally attached thereto. For simplicity, such embodiments of the communication device are not illustrated as extending from the sensor 258 throughout the figure. In some embodiments, the elongated positioning member 250 may also optionally function as a communication device. For example, the elongated positioning member 250 may optionally be configured as a conductive wire that is insulated along its length but exposed to the sensor 258 at the mounting point of the sensor 258.

[0166] In some embodiments, the sensor 258 communicates with a sensor data unit. In some embodiments, the sensor 258 communicates with the sensor data unit via a wired connection through a communication device. In some embodiments, the sensor 258 communicates with the sensor data unit wirelessly. In some embodiments, the sensor 258 is operated by the sensor data unit so that the sensing of the sensor 258 is performed in conjunction with the sensor data unit. For example, in an implementation in which the sensor 258 has a strain gauge bridge, the sensor data unit applies a predetermined excitation voltage to the input leads of the bridge and measures the voltage at the output leads of the bridge. The sensor data unit then determines the applied force or pressure from the measured output voltage. In some embodiments, the sensor 258 has dedicated circuitry for operation, and the sensor data unit receives the measured data from the sensor 258. In some embodiments, the sensor 258 communicates wirelessly with an external computing device.

[0167] In some embodiments, one or more user output devices comprise visual and / or auditory information elements, each configured to generate visual and / or auditory information, such as displays, LED lights, and speakers. These options are not limiting, and other feedback may also be delivered by one or more user output devices to the delivery device 202 c It may be provided to the users or operators of [the service / platform].

[0168] In some embodiments, the sensor data unit communicates with an external system (not shown). Such an external system may include a processor and memory. The memory stores a set of instructions that, when executed by the processor, cause the processor to perform a set of predetermined functions. In some embodiments, communication between the sensor data unit and the external system is carried out via a dedicated antenna and / or connections to various networks.

[0169] In some embodiments, the sensor data unit may optionally include one or more processors and memory, the memory having a plurality of instructions stored therein. When one or more processors read the plurality of instructions, the plurality of instructions cause one or more processors to execute the functions of the sensor data unit. In some embodiments, the sensor data unit is mounted on a microcontroller, and one or more peripheral devices of the microcontroller communicate with at least one sensor 258.

[0170] In some embodiments, at least one sensor 258 comprises at least one force sensor. As used herein, the term “force sensor” means any sensor that senses the magnitude of a force or pressure applied thereto. Wherever the term “force sensor” is used in this disclosure (in the description and / or claims), it should be noted that this may optionally include a pressure sensor. In some embodiments, the force sensor 258 may optionally include, for example, a piezoresistive sensor which is a strain gauge or strain gauge bridge, the resistance of which is a predetermined function of each of the forces applied thereto; a piezoelectric sensor whose voltage at its output is a predetermined function of each of the forces applied thereto; a capacitive sensor whose capacitance is a predetermined function of each of the forces applied thereto; and / or an optical sensor whose optical interferometry is a predetermined function of each of the forces applied thereto.

[0171] As described above, in one example, measurements from one or more sensors 258 are performed in conjunction with a sensor data unit. Alternatively, measurements from one or more sensors 258 are performed by dedicated circuits for each sensor 258 and transmitted to the sensor data unit.

[0172] When contact with the proximal contact surface 36 is identified by force measurement by the force sensor 258, the visual or auditory indication may be one or more user output devices, which may optionally include an LED light or other indication that can be mounted on the handle 204, as described above. Based on such indications, further advancement of the elongated positioning member 250 can be optionally stopped, after which the positioning and implantation of the artificial valve 100 can proceed as described above.

[0173] The expansion of the prosthetic valve 100 into the surrounding tissue may result in various risks associated with a mismatch between the valve's expansion diameter and the surrounding tissue. One complication is associated with valve over-inflation, which can exert excessive radial force on the surrounding anatomical structures, potentially leading to tissue damage or even annular rupture. Conversely, under-inflation of the valve may increase the risk of regurgitation in the vena cava or mitral valve. Inappropriate expansion may also result in unfavorable hemodynamic performance across valve 100, such as increased pressure gradient or flow obstruction due to the diameter mismatch, which may be associated with an increased risk of thrombus formation.

[0174] Therefore, in order to avoid the adverse effects of insufficient hemodynamic performance or valve regurgitation resulting from either excessive or insufficient expansion of the artificial valve 100, the clinician must be able to control the degree of valve expansion in accordance with real-time feedback received during the procedure, for example, indicating the current force exerted around the valve by the valve or the reaction force of the surrounding tissue resisting valve expansion.

[0175] Figure 5 shows an exemplary delivery assembly 200. d This shows the delivery assembly 200.d This is an exemplary implementation of the delivery assembly 200 and the delivery device 202 d The configuration may be similar to any embodiment described above with respect to a delivery assembly 200c including at least one elongated positioning member 250 having at least one force sensor 258 attached thereto, except that the force sensor 258 is oriented laterally (for example, facing a surface that may be substantially parallel to the longitudinal axis defined by the elongated positioning member) and configured to contact an axially extending anatomical surface between the artificial valve and the anatomical structure into which the artificial valve expands.

[0176] In addition to the position and orientation of the force sensor 258 on the elongated positioning member 250, the delivery assembly 200 d is the delivery assembly 200 c It will be understood that this can be structurally and functionally implemented as desired in accordance with any of the embodiments described above.

[0177] In some embodiments, the force sensor 258 is exposed from the outer delivery shaft 208 and may be optionally attached to a portion of an elongated positioning member 250 distal to the outflow end 104 of the prosthetic valve 100 during the valve expansion procedure, or it may be proximal to the proximal contact surface 36. In some embodiments, the force sensor 258 is attached to a side segment 256 of the loop 252. In some embodiments, the force sensor 258 is configured to face radially away from the central longitudinal axis Ca of the prosthetic valve 100 during the valve expansion procedure, such as toward the molar root wall 30, as shown in Figure 5. In some embodiments, the force sensor 258 is configured to face radially toward the central longitudinal axis Ca of the prosthetic valve 100 during the valve expansion procedure, for example toward the natural valve leaflets 22 positioned between the prosthetic valve 100 and the elongated positioning member 250, and / or components of the prosthetic valve 100 itself, such as the outer skirt 140 and / or frame 102 (embodiments not shown).

[0178] When the elongated positioning member 250 engages with the proximal contact surface 36, for example as shown in Figure 5, the force sensor 258 can be positioned between the artificial valve 100 and the molar root wall 30. When the valve 100 is initially compressed, the valve 100 is sufficiently spaced away from the molar root wall 30 so that the force sensor 258 is not yet forcibly pressed against any anatomical structure and / or side of the artificial valve 100. When the artificial valve 100 expands, the frame 102 is pushed closer to the molar root wall 30 by the inflation of the balloon or by any other expansion mechanism (e.g., release from a dedicated capsule for a self-expanding valve, or mechanical action in the case of a mechanically expandable valve) until the sensor 258 is forcibly pressed therein, thereby increasing the measured force reading of the sensor 258.

[0179] The sensor data unit may optionally be configured to output a signal indicating the force or pressure applied by the valve 100 to the surrounding tissue. Based on the determined magnitude of the force applied by the valve 100 during such expansion, the clinician can determine the maximum expansion diameter and optionally stop further expansion so as not to exceed a predetermined maximum threshold that could cause damage to the surrounding tissue.

[0180] The distally oriented force sensor 258 is shown in Figure 4 and is part of the delivery assembly 200. c As described above, the laterally oriented force sensor 258 is shown in Figure 5, and the delivery assembly 200 dAs described above, it should be understood that multiple sensors 258 can be optionally coupled to different regions of the same elongated positioning member 250. For example, as an optional configuration, the elongated positioning member 250 may be optionally equipped with both distally oriented force sensors 258 and laterally oriented force sensors 258, the force sensors 258 may be optionally coupled to the bottom curved segment 254 of the loop 252, or the force sensors 258 may be optionally coupled to the side segment 256 of the loop 252, thereby enabling the use of the sensors 258 of the elongated positioning member 250 for both the identification of contact with the proximal contact surface 36 and the measurement of the force applied by the artificial valve 100 to the surrounding anatomical structure, as described above. Furthermore, if the delivery device 202 includes a plurality of elongated positioning members 250, each elongated positioning member 250 can be optionally equipped with a force sensor 258 oriented distally, and at least one other elongated positioning member 250 can be optionally equipped with a force sensor 258 oriented laterally, thus each can be optionally equipped with a force sensor of a different type.

[0181] Improper valve expansion can also lead to undesirable hemodynamic performance across the valve, such as increased pressure gradients. Therefore, it may be desirable to provide clinicians with additional real-time transvalvular pressure gradient measurements during valve implantation procedures.

[0182] Figure 6 shows an exemplary delivery assembly 200. e This shows the delivery assembly 200. e This is an exemplary implementation of the delivery assembly 200, in which a single laterally oriented sensor 258 is connected to the delivery device 202. d Instead of being illustrated for this purpose, the positioning member 250 is mounted in the region of the delivery assembly 200, which is configured to be positioned distal to the outlet end 104 of the valve 100 during the valve expansion procedure. eThe elongated positioning member 250 may be similar to any embodiment described above with respect to a delivery assembly 200d including at least one elongated positioning member 250 having at least one sensor 258 attached thereto, except that the elongated positioning member 250 is shown to include at least two pressure sensors 258a and 258b and is attached to different regions of the positioning member 250 that are axially spaced apart from each other.

[0183] Delivery device 202 d Unlike the sensor 258, the delivery device 202 e The pressure sensor 258 is mounted on a region of the positioning member 250 that is exposed from the outer delivery shaft 208, but is configured to remain proximal to the outflow end 104 of the prosthetic valve 100 during valve expansion procedures. The pressure sensor 258 is configured to measure blood pressure along the proximal region of the prosthetic valve 100. Thus, the pressure gradient of the downstream prosthetic valve 100 can be measured by the difference between the pressure readings of both sensors 258b and 258a. In some embodiments, the delivery device 202 d Unlike the sensor 258 in some exemplary embodiments, the delivery device 202 e The pressure sensors 258a and 258b are oriented toward the central longitudinal axis Ca and away from the molar wall so that they remain exposed to blood flow during valve implantation procedures and are not contacted by any other tissue that could interfere with these readings.

[0184] Although two axially spaced pressure sensors 258 are shown in Figure 6, it should be understood that three or more sensors 258 can be optionally used, for example, to increase the resolution of pressure gradient readings. In the illustrated example, two pressure sensors 258a and 258b are connected to the same elongated positioning member 250, but it should be understood that in some embodiments, for example, if multiple elongated positioning members 250 are provided, each elongated positioning member 250 may be configured to include one of the pressure sensors 258 positioned at different axial positions relative to each other.

[0185] Figure 7 shows an exemplary delivery assembly 200. f This shows the delivery assembly 200. f This is an exemplary implementation of the delivery assembly 200, and the delivery device 202 in Figure 6. e It is shown that it is connected to the same positioning member 250. Instead of at least two laterally oriented pressure sensors 258, the delivery device 202 f The elongated positioning member 250 optionally includes a pressure sensor 258 (such as the single pressure sensor 258a shown in Figure 7), while the delivery assembly 200 f Another component may be similar to any embodiment described above with respect to a delivery assembly 200e including at least one elongated positioning member 250 having at least one pressure sensor 258 attached thereto, except that it includes at least one additional pressure sensor 258b.

[0186] Delivery Assembly 200 f The first pressure sensor 258a is mounted on a region of the positioning member 250 that is exposed from the outer delivery shaft 208, but is configured to remain proximal to the outlet end 104 of the artificial valve 100 during the valve expansion procedure. f The second pressure sensor 258b is coupled to another component of the delivery assembly 200f, and the delivery assembly 200 f The configuration may be aligned proximal, distal, or medially to the artificial valve 100 during the valve implantation procedure. The additional components to which the elongated positioning member 250 and the second pressure sensor 258b are attached may optionally be axially movable relative to each other, so that the first pressure sensor 258a and the second pressure sensor 258b are axially separated from each other during the valve implantation procedure.

[0187] In some embodiments, the second pressure sensor 258b may be coupled to the nose cone shaft 220, such as the distal portion 224 of the nose cone shaft 220, which may be configured to extend through the inlet end 106 of the prosthetic valve 100 during the implantation procedure, as shown in Figure 7. This configuration allows the second pressure sensor 258b to be positioned in the left ventricle 32, such as the LVOT 34, while the first pressure sensor 258a is positioned within the aorta 26. In this way, the pressure gradient can be measured across the prosthetic valve 100 during its inflation and implantation procedure.

[0188] The second pressure sensor 258b is shown connected to the nose cone shaft 220 in Figure 7, but this is shown for illustrative purposes only, and the second pressure sensor 258b is connected to the delivery assembly 200 f It should be understood that it can be optionally connected to other components in the same manner. In some embodiments, the second pressure sensor 258b is coupled to the nose cone 236. In some embodiments, the second pressure sensor 258b is coupled to the balloon catheter 210. In some embodiments, the second pressure sensor 258b is coupled to the outer delivery shaft 208. In some embodiments, the second pressure sensor 258b is coupled to the guide wire 50. In some embodiments, the second pressure sensor 258b is coupled to the artificial valve 100 itself, such as the outer skirt 140, frame 102, etc. In some embodiments, the second pressure sensor 258b is coupled to the delivery assembly 200, which is not shown in Figure 7. f It is coupled to another shaft. In some embodiments, the second pressure sensor 258b is connected to the delivery assembly 200 f It is coupled to other shafts or a pigtail shaft (not shown) of a catheter that can be used in combination with it.

[0189] Figure 7 shows a single pressure sensor 258a in combination with an elongated positioning member 250, and a single pressure sensor 258b in combination with another component of the delivery assembly, such as a nose cone shaft 220, but multiple pressure sensors 258 may optionally be connected to the elongated positioning member 250, and two or more sensors 258 may be connected to the nose cone shaft 220 or the delivery assembly 200. f It may be configured to be optionally coupled to any other component, such as the delivery assembly 200, including the nose cone shaft 220. f Although only one other component is shown to include the pressure sensor 258, the delivery assembly 200 f It should be understood that two or more additional components of the same type may optionally include pressure sensors. For example, a first pressure sensor 258a may optionally be connected to an elongated positioning member 250, an additional pressure sensor 258b may optionally be connected to a nose cone shaft 220, and another pressure sensor 258 may be connected to a delivery assembly 200 such as a nose cone 236, an artificial valve 100, or any other component. f It may be further connected to other components.

[0190] In some embodiments, a sensor 258 connected to an elongated positioning member 250 is a flow sensor 258. The flow sensor 258 may optionally be coupled to a region of the positioning member 250 exposed from the outer delivery shaft 208, but may be configured to remain proximal to the outlet end 104 of the artificial valve 100 during the valve expansion procedure. The flow sensor 258 may be oriented laterally toward the central longitudinal axis Ca and can be used to measure the flow downstream of the artificial valve 100 during the valve implantation procedure.

[0191] In some embodiments, the flow sensor 258 comprises an ultrasonic flow sensor. As used in this disclosure, the term “ultrasonic flow sensor” means a flow sensor based on ultrasonic detection. In particular, as is known to those skilled in the art, an ultrasonic transducer generates ultrasonic waves directed at a fluid, and the detected waves after interaction with the fluid indicate the fluid velocity. In one embodiment, velocity measurement may be performed by any suitable method, such as by measuring the Doppler shift.

[0192] In some embodiments, the flow sensor 258 comprises an optical flow sensor. As used in this disclosure, the term “optical flow sensor” means a flow sensor based on photodetection. In particular, in one embodiment, the optical flow sensor may include a beam of light configured to heat blood, and the temperature fluctuations caused by the flow fluctuations are detected by an optical fiber sensor. In some embodiments, the optical flow sensor may optionally include a pair of light rays and a detection mechanism configured to measure the time difference between the scattering of each ray. In some embodiments, blood flow can be measured through the use of a monochromatic laser diode. In particular, the laser probe is inserted into the tissue and turned on, where light is scattered, and a small portion is reflected back to the probe. The signal is then processed to calculate blood flow.

[0193] In some embodiments, the flow sensor 258 comprises a mechanical flow sensor. As used herein, the term “mechanical flow sensor” means a flow sensor configured to detect flow based on mechanical effects of fluid flow known to those skilled in the art. These mechanical effects may include positive displacement-based flow meters and / or pressure-based flow meters.

[0194] One or more elongated positioning members 250 are part of an exemplary delivery assembly 200. c , 200 d , 200 e and / or 200 fIt should be understood that the configuration may optionally include any combination of the sensors 258 described above with respect to any of the above. For example, one or more elongated positioning members 250 include one or more distally oriented force sensors 258 for identifying contact between the elongated positioning member 250 and the proximal contact surface, one or more laterally oriented force sensors 258 for measuring the force exerted by the prosthetic valve on the surrounding anatomical structure when the prosthetic valve is expanding, one or more pressure sensors 258 for measuring the pressure gradient across the downstream prosthetic valve 100 and / or the prosthetic valve 100, and / or one or more flow sensors 258 for measuring the flow downstream prosthetic valve 100.

[0195] Figure 8 shows an exemplary delivery assembly 200. g This shows the delivery assembly 200. g This is an exemplary implementation of the delivery assembly 200, and therefore the delivery assembly 200 g Delivery device 202 g However, it includes all the configurations described throughout this disclosure for the delivery assembly 200, except that it further comprises an inflatable positioning balloon 260 at the distal end of an expansion tube 262 extending distally from the handle 204. The expansion tube 262 optionally extends through the lumen of the outer delivery shaft 208, etc., of the delivery device 202 g It may be configured to extend through a shaft or catheter.

[0196] In some embodiments, the expansion tube 262 may be configured to extend optionally through the space formed between the balloon catheter 210 and the outer delivery shaft 208, as illustrated in Figure 8. The expansion tube 262 supporting the positioning balloon 260 may optionally be connected to the delivery device 202, such as the outer delivery shaft 208 or any other shaft. gThe expansion tube 262 may be independently operated through a sheath or catheter and may extend from the shaft (e.g., outside the outer delivery shaft 208) via, for example, the operation of the handle 204 by a clinician. Although the expansion tube 262 is illustrated to extend from the outer delivery shaft 208, in some embodiments the delivery device may optionally include a plurality of shafts that can be arranged adjacent to one another within the same sheath. Accordingly, any reference to an expansion tube and positioning balloon extending through the outer delivery shaft 208 as disclosed herein should be understood to also refer to an expansion tube and positioning balloon extending through any other sheath of the shaft of the delivery device.

[0197] The inflation tube 262 supporting the positioning balloon 260 optionally includes a delivery assembly 200 such as an artificial valve 100, an external delivery shaft 208, and / or a balloon catheter 210. g It may be axially movable relative to other components. The handle 204 may optionally include a mechanism (not shown) for controlling the axial movement of the positioning balloon 260. Although a single expansion tube 262 having a positioning balloon 260 is illustrated in Figure 8, it should be understood that any other number is contemplated, including any number of two or more expansion tubes 262, each having a positioning balloon 260 at its distal end and spaced circumferentially apart from one another around the artificial valve 100.

[0198] The expansion tube 262 may be configured to be optionally fluid-connected at its proximal end to a fluid source (not shown) in order to inflate the positioning balloon 260. As used in this disclosure, the term expansion fluid means the fluid used to inflate the positioning balloon 260 (e.g., saline solution). The expansion fluid from the fluid source (e.g., syringe or pump) can flow through the lumen of the expansion tube 262 into the cavity of the positioning balloon 260 and inflate it. Furthermore, the expansion tube 262 may be configured to draw fluid from the internal cavity of the positioning balloon 260 to deflate the balloon 260. Thus, positioning the balloon 260 is configured to transition between a deflated state and an expanded state.

[0199] Delivery Assembly 200 g The positioning balloon 260 can be optionally advanced from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. The positioning balloon 260 can optionally be moved into the lumen of the delivery assembly 200, such as the lumen of the lateral delivery shaft 208, before reaching the implantation site. g It can be held in a deflated state inside the sheath. Upon reaching the aortic valve 20, the inflation tube 262 may be configured to optionally extend from the distal end of the outer delivery shaft 208 to expose the positioning balloon 260 from the outer delivery shaft 208, so that the positioning balloon 260 advances toward the proximal contact surface 36 (e.g., the cusp of the natural valve leaflet 22), but optionally moves away from there.

[0200] At this stage, the positioning balloon 260 may optionally be configured to inflate and advance further distally to the contact surface in the implantation region, with the distal end of the balloon 260 indicating the position of each surface of the natural annular portion, and enabling the artificial valve 100 to be positioned within the host valve (e.g., within the natural atmospheric pressure valve) with respect to the inflatable balloon 260, similar to what is described above with respect to the elongated positioning member 250. For example, as an optional configuration, the positioning balloon 260 may advance to contact and rest on the proximal contact surface 36 of the natural heart valve 20, and the balloon 260 or inflation fluid injected into its cavity may be radiopaque in such a manner that it can be identified under fluoroscopy (or other suitable imaging modality), and the artificial valve 100 may be configured to move axially with respect to the bottom end of the balloon 260, indicating the position of the annular portion 24, and to assist in precisely positioning the artificial valve 100 with respect to the annular portion 24 without requiring the injection of contrast agent.

[0201] The inflation tube 262 may optionally be axially movable distal to the outer delivery shaft 208, and optionally be configured to advance so that the positioning balloon 260 moves radially away from the outer delivery shaft 208 and / or the artificial valve 100. As shown in Figure 8, simultaneously with or in succession to the inflation of the balloon 260d (e.g., anterior-posterior), the artificial valve 100 may optionally advance from the distal end of the outer delivery shaft 208 toward and through the natural molar ring 24, for example together with the balloon catheter 210. Advancement of the inflation tube 262 may optionally continue until the positioning balloon 260 reaches the proximal contact surface 36.

[0202] In some embodiments, when the positioning balloon 260 is inflated, its distal end generally forms a non-traumatic surface to avoid damage to surrounding anatomical structures during operation. The distal region of the positioning balloon 260 can further increase the area in contact with the contact surface 36 when inflated.

[0203] Using tactile feedback from the positioning balloon 260, produced by contact between its distal end and the proximal contact surface 36, the clinician can axially manipulate the prosthetic valve 100 to position the inlet end 104 at a desired position relative to the surface of the annular portion 24 contacted by the balloon 260, in a manner similar to that described above with respect to the positioning of the valve 100 relative to the elongated positioning member 250. Once the prosthetic valve 100 is positioned at the desired position relative to the imaged portion of the positioning balloon 260, corresponding to the natural annular portion 24, the clinician can optionally inflate the expansion balloon 212, which can be supplied by the same or a different expansion fluid source, or otherwise perform expansion / deployment of the prosthetic valve 100 to the desired position within the natural annular portion 24 (e.g., via removal of a suppressor sheath or capsule in the case of a self-inflating valve, or by activation of a mechanical actuator in the case of a mechanically expandable valve). During the expansion of the artificial valve, the positioning balloon 260 remains engaged with the proximal contact surface 36 (for example, pressed against it) and optionally, during the implantation procedure, the delivery assembly 200 g This absorbs at least a portion of the force applied to the molar flap 20. In some embodiments, the positioning balloon 260 may be configured to create a flexible or semi-flexible structure, as an optional configuration. The positioning balloon 260 may be formed from any other polymer such as PET, silicone, elastomer, nylon, polyethylene, or copolymer.

[0204] As described above, in some embodiments, the balloon may optionally be made of a radiopaque material, or may optionally include radiopaque markings attached thereto. In some embodiments, the inflation fluid may also include a contrast agent. Any of these solutions may allow visibility of a portion of the balloon 260 that contacts the proximal contact surface 26 during valve positioning, and may also allow tracking of changes in the shape of the positioning balloon 260 under fluoroscopy or other suitable imaging modality. As shown in Figure 8, the positioning balloon 260 is held between the prosthetic valve 100 and the molar root wall 30, so that the expansion of the prosthetic valve compresses the positioning balloon 260 in a manner that can cause its appropriate deformation. In some embodiments, the internal pressure of the inflation fluid within the positioning balloon 260 is low enough to prevent the positioning balloon 260 from resisting valve expansion. In some embodiments, the expansion tube 262 is configured to allow the flow of expansion tube from the positioning balloon 260 back through it, and to allow for gradual balloon deflation as it is compressed between the prosthetic valve 100 and the molar root wall 30 during expansion of the prosthetic valve. In such cases, the position of the frame 102 of the prosthetic valve 100 relative to the natural anatomical structure can be visualized and estimated by the deformation of the positioning balloon 260.

[0205] In some embodiments, if the positioning balloon 260 is still at least partially inflated before the full expansion of the artificial valve 100, it can be voluntarily fully deflated and retracted from the molar root 28, thereby allowing the artificial valve 100 to fully expand against the inner wall 30 of the molar root 28. The positioning balloon 260 may optionally (but not necessarily) be retracted into the outer delivery shaft 208, and the expansion balloon 212 (if used) may also be deflated to a reduced diameter, and the catheter delivery device 202 g The artificial valve 100 can then be removed from the patient and implanted into the natural valve 20.

[0206] Figure 9 shows an exemplary delivery assembly 200. h This shows the delivery assembly 200. hThis is an exemplary implementation of the delivery assembly 200, and therefore the delivery device 202 of the delivery assembly 200h. h Except for further comprising a stabilization filter 264, the delivery assembly 200 includes all the configurations described throughout this disclosure. The stabilization filter 264 provides the delivery assembly 200 during positioning and expansion of the artificial valve 100. h It is configured to function both as a centering and stabilizing component for stabilizing the natural valve 20, and as an embolic filter for capturing embolic fragments that may become dislodged during the operation and expansion of the artificial valve 100 within the natural valve 20.

[0207] One of the potential complications associated with artificial valve implantation is the removal of atherosclerotic and / or thrombotic fragments, also known as “embolic fragments.” The most serious consequence of embolic fragments is that they travel downstream with the bloodstream and can cause stroke, among other diseases in the patient. Advantageously, the disclosed stabilizing filter 264 can function simultaneously as both a stabilizing and / or centering member and a filter for capturing embolic fragments, thereby enabling the delivery assembly 200 h This simplifies their use while saving costs by replacing two devices, which could be used separately to provide each of these functions, with a single device that provides both functions.

[0208] The stabilizing filter 264 is configured to transition between a folded state and an unfolded or expanded state. The stabilizing filter 264 may optionally include a braided mesh, but its structure can vary and may optionally be, for example, braided, meshed, perforated, etc. In some embodiments, the stabilizing filter 264 may optionally be constructed from a wire mesh, for example, shapeset nitinol wire braid. The stabilizing filter 264 may optionally define pores sized to optimize embolic capture of blood flowing through it. In some embodiments, the average or maximum pore size of the stabilizing filter 264 may optionally be 40, 100, 150, 200, or 300 microns, or any value in between.

[0209] In some embodiments, the stabilizing filter 264 optionally connects to the delivery device 200, such as the outer delivery shaft 208 or any other shaft. h It is operated independently through the sheath or catheter and can be deployed from the shaft (e.g., outside the external delivery shaft 208) via, for example, the movement of the handle 204 by a clinician.

[0210] Delivery Assembly 200 h The stabilizing filter 264 can optionally advance from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. The stabilizing filter 264 can optionally advance into the lumen of the delivery assembly 200, such as the lumen of the outer delivery shaft 208, before reaching the implantation site. hIt can be held in a folded state inside the sheath. Upon reaching the aortic valve 20, the stabilizing filter 264 optionally unfolds from the distal end of the outer delivery shaft 208, exposing the distal end of the outer delivery shaft 208 at a position proximal to the molar ring 24 so that the stabilizing filter 264 can optionally self-expand radially toward the molar wall, allowing the prosthetic valve 100, or any shaft or catheter coupled to or carrying the prosthetic valve 100, to extend distally through it toward the natural annular portion 24. The pores of the stabilizing filter 264 allow blood flow through it during the implantation procedure.

[0211] In its deployed and expanded state, the stabilizing filter 264 can function as a docking or positioning member configured to improve the accuracy of deployment and implantation of the artificial valve 100 by circumferentially centering the artificial valve 100 and / or any attached catheter / shaft, such as a balloon catheter 210. As described above, the stabilizing filter 264 may optionally be formed of a shape memory material configured to self-expand when not restricted by an outer shaft, such as an outer delivery shaft 208. Shape memory can be employed in a braided mesh by heat treatment, for example, to achieve a spring temper in stainless steel or to set shape memory in a sensitive metal alloy such as nitinol. When the stabilizing filter 264 is expanded against the molar wall, the force exerted by the stabilizing filter 264 against the surrounding anatomical structure is high enough to hold it in place and resist its unintended axial movement during operation and expansion of the artificial valve 100.

[0212] In some embodiments, the stabilizing filter 264 is located in the delivery assembly 200. hAttached to the shaft of , the delivery assembly 200h may be configured to be optionally axially movable relative to an outer sheath or shaft such as the outer delivery shaft 208. In some embodiments, the stabilization filter 264 is coupled to a portion of the balloon catheter 210 proximal to the expansion balloon 212 such that, as shown in FIG. 9, upon reaching the implantation site and pushing the balloon catheter 210 distally relative to the outer delivery shaft 208 and / or retracting the outer delivery shaft 208 relative to the balloon catheter 210, the stabilization filter 264 is exposed and serves to enable its expansion against the aortic wall. In some embodiments, as an optional configuration, the stabilization filter 264 may be configured to be coupled to a different shaft that is capable of passing through the outer delivery shaft 208 such as a push shaft 214 or other independent shaft (not shown).

[0213] To prevent embolic debris from flowing downstream past the stabilization filter 264, the stabilization filter 264 extends across the entire cross-sectional area of the blood vessel (e.g., aorta 26) between the vessel wall and the shaft or catheter to which it is attached such that, in its expanded state, there is no opening between the outer diameter of the stabilization filter 264 and the attachment region to the shaft that holds it, which is larger than the pore size defined by the mesh. In this way, as long as the stabilization filter 264 is expanded proximal to the prosthetic valve 100, embolic debris suspended in the blood is captured by the stabilization filter 264, preventing them from flowing into the distal vascular bed.

[0214] Concurrent with or consecutive to (e.g., before and after) the deployment of the stabilization filters 264, the prosthetic valve 100 can optionally advance from the distal end of the outer delivery shaft 208, e.g., with a balloon catheter 210, toward and optionally through the native annulus 24, as shown in FIG. 9. With the stabilization filters 264 held in place, the clinician can optionally inflate the dilation balloon 212 or otherwise inflate it (e.g., in the case of a self-expanding valve, by removing a restraining sheath or capsule, or in the case of a mechanically expandable valve, via activation of a mechanical actuator), thereby effecting expansion / placement of the prosthetic valve 100 at a desired location within the native annulus 24. Optionally, after full or at least partial expansion of the prosthetic valve 100, a re-sheathing of the stabilization filters 264 can be performed, such as retracting back into the outer delivery shaft 208, shrinking the dilation balloon 212 (if used) to reduce its diameter, and withdrawing the catheter delivery device 202 h from the patient, leaving the prosthetic valve 100 implanted within the native valve 20.

[0215] FIG. 10 shows a delivery assembly 200 carrying an exemplary prosthetic valve 100 deployed within a native prosthetic valve 20. The prosthetic valve 100 i includes all of the configurations described for the prosthetic valve 100 throughout this disclosure, except that the prosthetic valve 100 i is an exemplary implementation of the prosthetic valve 100 and thus further includes one or more positioning struts 160 configured to transition the prosthetic valve 100 i between a compressed state and a deployed or released state. The prosthetic valve 100 i is illustrated in FIG. 10 and FIGS. 12A - 12B described below, but is shown without soft components such as skirts or valve tips for clarity.

[0216] Each positioning post 160 has a fixed end 162 attached to the frame 102 and a free end 164 opposite the fixed end 162. Any reference to the various forms of “positioning post 160” in this specification may similarly refer to a single positioning post 160 unless otherwise stated. In some embodiments, the positioning posts 160 are formed integrally with the rest of the frame 102. For example, if the frame 102 is formed by laser cutting a single tube, the positioning posts 160 may also be formed by laser cutting the same tube. In some embodiments, the positioning posts 160 are formed separately and then attached to the frame 102, for example, by adhesive, sutures, welding, or other means.

[0217] In some embodiments, the positioning posts 160 are connected at their fixed ends 162 to joints 120 of the frame 102, which may optionally be closer to the inlet end 106 than to the outlet end 104, as shown in Figure 10. In some embodiments, the positioning posts 160 are connected at their fixed ends 162 to the inlet apex 124. In some embodiments, the free end 164 is constructed to be non-traumatic (e.g., blunt or lacking sharp edges) to avoid damage to surrounding anatomical structures during operation, such as being rounded and covered by a non-traumatic covering, covering, etc.

[0218] The positioning support 160 can optionally be shaped by, for example, heat treatment, and as a result, if not constrained by an outer covering element such as a sheath or capsule, the positioning support 160 extends radially away from the central longitudinal axis Ca such that its free end 164 is positioned radially away from the frame 102 and oriented proximal in the free or deployed state.

[0219] The natural valve 20 may define a distal contact surface 38, which is defined as the distally facing surface of the natural valve 20 opposite to the proximal contact surface 36. The distal contact surface 38 may face the LVOT 34. The delivery assembly 200 can advance from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. Artificial valve 100i can optionally be held in a crimped or compressed configuration before reaching the implantation site, and the positioning strut 160 can also hold the valve 100 i in a compressed state when the valve is positioned within a capsule or sheath (such as outer delivery shaft 208), and can optionally be extended in a relatively linear fashion (e.g., parallel to central longitudinal axis Ca). The valve advances such that its inflow portion is present within the left ventricle 32, at which point the prosthetic valve 100 i can be optionally exposed from the sheath or capsule by advancing distally thereagainst and / or by housing the sheath or capsule from the valve 100 i Thereby, the positioning strut 160 springs to its free or deployed preformed state such that the free end 164 is directed proximally toward the annulus 24 and the distal abutment surface 38, and can optionally curve radially outwardly away from the frame 102. When the free end 164 is distally spaced from the distal abutment surface 38, the prosthetic valve 100

[0220] can be optionally pulled proximally to approximate the positioning strut 160 to the annulus 24 such that the free end 164 contacts the distal abutment surface 38. In some embodiments, the prosthetic valve 100 i can optionally be continuously, at least partially expanded while being pulled proximally relative to the annulus 24, which can help to position the free end 164 further radially apart and in alignment with the distal abutment surface 38. Although two positioning struts 160 are illustrated in FIG. 10, it should be understood that any other number such as a single positioning strut 160 or three or more positioning struts 160 are contemplated. i

[0221] ​Using the tactile feedback from the positioning strut 160 created by the contact of the free end 164 with the distal abutment surface 38, the clinician positions the inlet end 104 relative to the surface of the annulus 24 contacted by the positioning strut 160 in a manner similar to that described above with respect to the positioning of the valve 100 relative to the elongate positioning member 250 so that the prosthetic valve 100 i can be axially manipulated. When the prosthetic valve 100 i is positioned in the desired location, corresponding to the natural annulus 24, relative to the imaged portion of the positioning strut 160, the clinician can optionally inflate the dilation balloon 212 or otherwise cause it to expand (e.g., in the case of a self-expanding valve, via removal of a restraining sheath or capsule, or in the case of a mechanically expandable valve, by activation of a mechanical actuator), resulting in the expansion / disposition of the prosthetic valve 100 within the natural annulus 24 i . During expansion of the prosthetic valve, the positioning strut 160 remains engaged (e.g., pressed) with the distal abutment surface 38 and optionally absorbs at least a portion of the force applied to the molar valve 20 by the delivery assembly 200 during the implantation procedure.

[0222] In some embodiments, the positioning support 160 may be relatively prominent under applicable imaging guide modalities such as fluoroscopy, echocardiography, and / or other imaging methods. As described above, as an optional configuration, the positioning support 160 may, in some embodiments, be made of a shape memory material such as nitinol. Since nitinol is sometimes difficult to see under radiography, radiopaque markers (such as gold) may be added, or nitinol may be mixed with a radiopaque material to be easily identifiable under radiography during the procedure. Thus, in some embodiments, the positioning support 160 may be made of a radiopaque material or may include a radiopaque marker. This can, in some cases, help in identifying contact between the positioning support 160 and the contact surface 38. For example, when using fluoroscopy or other suitable imaging techniques, a clinician may see the positioning support 160 begin to buckle, bend, or otherwise deform when it engages with (i.e., is pressed against) the distal contact surface 38. Therefore, contact with the positioning support 160 can be identified by tactile feedback and / or visually by fluorescence imaging or other image guidance.

[0223] Figures 11-12B show artificial valve 100 i Exemplary delivery assembly 200 that can be used for delivery and placement. i This shows the distal portion. Delivery assembly 200 i This is an exemplary implementation of the delivery assembly 200, and therefore the delivery assembly 200 i Delivery device 202 i However, it includes all the features described throughout this disclosure for the delivery assembly 200, except that it further comprises an inner capsule 274 and an outer capsule 270 that are movable axially relative to each other.

[0224] Figure 11 shows the inner capsule 274 located within the outer capsule 270, and for clarity, the artificial valve 100 i or delivery device 202 iOther components are removed from view. Each of the inner capsule 274 and the outer capsule 270 can optionally be connected to a delivery device 202 such as the outer delivery shaft 208. i The outer capsule 270 and / or the shaft attached thereto may be configured to extend through the lumen of the outer delivery shaft 208. The outer capsule 270 may have a larger diameter than the diameter defined by the inner capsule 274, so that the inner capsule 274 may reside inside and extend through the outer capsule 270.

[0225] It should be understood that the outer capsule 270 may be a separate component attached to the corresponding shaft, or it may be formed as an integral distal portion of the shaft. Similarly, the inner capsule 274 may be configured to extend through the lumen of the outer capsule's shaft, or it may be configured to be an integral distal portion of the shaft, or it may be a separate component attached to the corresponding shaft.

[0226] The inner capsule 274 extends proximal to the distal end 276 of the inner capsule, and the outer capsule 270 extends proximal to the distal end 272 of the outer capsule. In some embodiments, as an optional configuration, the inner capsule 274 may further include one or more slots 278, each extending from the distal end 276 of the inner capsule to the proximal end 280 of the slot. The number of slots 278 is, as an optional configuration, the valve 100 configured to reside within the inner capsule 274. iThe number of positioning posts 160 may be matched by the configuration. The positions of the slots 278 around the inner capsule 274 may, as an optional configuration, be matched by the positions of the positioning posts 160 around the frame 102. The width of each slot 278 may, as an optional configuration, be greater than the width of the positioning posts 160 to allow its movement through the slot 278. The length of each slot 278 can be set to allow appropriate extension of the positioning posts 160 as they pass through when transitioning between the folded and free states. In the embodiment shown in Figure 11, the inner capsule 274 is shown partially offset distally to the outer capsule 270 so that the entire length of the slots 278 is exposed from the outer capsule 270.

[0227] Figures 12A and 12B show the delivery device 202 i The distal portion is shown in two states, with the positioning support 160 shown in a compressed state (Figure 12A) and a free state (Figure 12B), while the artificial valve 100 i It remains in a compressed configuration. Figure 12A shows the artificial valve 100 being delivered toward the implantation site. i The state of the positioning support 160 is shown. As shown, in this state, the artificial valve 100 i The inner capsule 274 is held in a crimped or compressed configuration inside the inner capsule 274, while the outer capsule 270 is positioned around the inner capsule 274 and covers it. The outer capsule 270 can optionally be aligned with the inner capsule 274 in this state such that the distal end 272 of the outer capsule 270 is aligned with or close to the distal end 276 of the inner capsule 276, but this is not required as long as the outer capsule 270 covers a sufficient portion of the slot 278 and holds the positioning support 160 in a compressed state.

[0228] As shown, artificial valve 100 iWhen positioned within the inner capsule 274, the positioning support 160 aligns with the slot 278 and attempts to extend outward through the slot 278. The inner wall of the outer capsule 270 can optionally hold the positioning support 160 in a relatively straight configuration, as shown in Figure 12A. Artificial valve 100 including positioning support 160 i If the distal portion is located inside the left ventricle 32, for example, inside the LVOT 34 (optionally), the outer capsule 270 can be retracted proximal 90° relative to the inner capsule 274, and / or the inner capsule 274 can be pushed distally relative to the outer capsule 270, as shown in Figure 12B, the distal end 272 of the outer capsule can optionally be positioned at or proximal to the proximal end 280 of the slot, exposing the slot 278, allowing the positioning support 160 to spring radially outward and assume their pre-formed free state. The positioning support 160 may, as shown, optionally be pre-formed to have a curved C-shape or U-shape in their free state, with a concave side facing the distal contact surface 38.

[0229] Therefore, both the inner capsule 274 and the outer capsule 270 are, as described above with respect to Figure 10, the artificial valve 100 i Move it proximal to the artificial valve 100 i It can be exposed.

[0230] Figures 13A and 13B show an exemplary delivery assembly 200. j This shows the delivery assembly 200. j This is an exemplary implementation of the delivery assembly 200, and therefore the delivery device 202 of the delivery assembly 200j. j However, nose cone shaft 220 jExcept for further including one or more positioning arms 228 that extend through the lumen 222 and are configured to transition between a compressed state and an unfolded or free state, the delivery assembly 200 includes all the configurations described throughout this disclosure. The artificial valve 100 is shown in Figures 13A-13B, but for clarity, soft components such as skirts or leaflets are omitted from the illustration.

[0231] Any reference to multiple forms of positioning arm 228' in this disclosure may, unless otherwise stated, refer to a single positioning arm 228. Nose cone shaft 220 j It includes one or more side openings 226 formed proximal to its distal portion 224, for example, the nose cone 236. The positioning arm 228 moves toward and away from the side opening 226, etc., the nose cone shaft 220 i It is movable in the axial direction relative to the side openings 226. The number of side openings 226 may, as an optional configuration, be configured to match the number of positioning arms 228. Each positioning arm 228 defines a free end 232 that can be optionally extended through the corresponding side opening 226. The proximal end of a positioning arm 228 (not shown) may, as an optional configuration, extend to a handle 204 and be operated by a knob 206 to move the positioning arm 228 axially in the distal or proximal direction.

[0232] The positioning arm 228 may be shaped arbitrarily by, for example, heat treatment, resulting in the nose cone shaft 220 as shown in Figure 13A. j If not restricted by a wall, the positioning arm 228 has a free end 232 on the nose cone shaft 220. j The configuration may optionally extend radially away from the central longitudinal axis Ca so as to be positioned radially away from the central axis and oriented proximal in the free or unfolded state.

[0233] Delivery Assembly 200 jAs an optional configuration, the prosthesis may advance from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. The positioning arm 228 may be held in a compressed state, with its free end 232 aligned with the lateral opening 226 or positioned proximal to the lateral opening 226, as shown in Figure 13A, and may extend voluntarily in a relatively linear manner (e.g., parallel to the central longitudinal axis Ca) before reaching the implantation site. The prosthesis valve 100 advances so that its inflow portion is located within the left ventricle 32, and the distal portion 224 of the nose cone shaft extends beyond the valve 100 so that the lateral opening 226 is positioned distal to the inflow end 106 of the valve 100.

[0234] At this stage, as shown in Figure 13B, the positioning arm 228 can optionally advance distally through the lumen 222 of the nose cone shaft, and as a result, the positioning arm 228 moves toward the nose cone shaft 220 j Extending radially away from the positioning arms 228 through the side openings 226, and assuming their pre-formed free state, a curved section 230 is formed between the side openings 226 and the free end 232, with the free end 232 oriented toward the annular portion 24 and the distal contact surface 38. The clinician can control the length of the exposed portion of the positioning arms 228 to form longer or shorter curved sections 230 according to the patient's specific anatomical structure in order to align the free end 232 with the distal contact surface 38. Although two positioning arms 228 are illustrated in Figures 13A-13B, it will be understood that any other number, such as one positioning arm 228 or three or more positioning arms 228, is conceivable.

[0235] Using the tactile feedback from the positioning arm 228 created by the contact between the free end 232 and the distal abutment surface 38, the clinician axially manipulates the prosthetic valve 100 in a manner similar to that described above with respect to the positioning of the valve 100 relative to the elongate positioning member 250 to position the inflow end 104 at a desired position relative to the surface of the annulus 24 contacted by the positioning arm 228. When the prosthetic valve 100 is positioned at the desired position, corresponding to the natural annulus 24, with respect to the imaged portion of the positioning arm 228, the clinician can optionally inflate the dilation balloon 212 or otherwise cause inflation (e.g., in the case of a self-expanding valve, via removal of a restraining sheath or capsule, or in the case of a mechanically expandable valve, by activation of a mechanical actuator), resulting in expansion / placement of the prosthetic valve 100 within the natural annulus 24. The positioning arm 228 may be preformed, as an optional configuration as shown, to form curved sections 230 that are concave on the side facing the distal abutment surface 38 and are C-shaped or U-shaped in their free state.

[0236] During expansion of the prosthetic valve, the positioning arm 228 remains engaged (e.g., pressed) with the distal abutment surface 38 and optionally absorbs at least a portion of the force applied to the molar valve 20 by the delivery assembly 200 during the implantation procedure. j

[0237] In some embodiments, the positioning arm 228 may be relatively prominent under applicable imaging-guided modalities such as fluoroscopy, echocardiography, and / or other imaging methods. As described above, in some embodiments, the positioning arm 228 may be fabricated from a shape-memory material such as nitinol, as an optional configuration. Since nitinol is sometimes difficult to see under radiography, radiopaque markers (such as gold) may be added, or nitinol may be mixed with a radiopaque material to be easily identifiable under radiography during the procedure. Thus, in some embodiments, the positioning arm 228 may be fabricated from a radiopaque material or may include radiopaque markers. This can, in some cases, help in identifying contact between the positioning arm 228 and the contact surface 38. For example, when using fluoroscopy or other suitable imaging techniques, a clinician may observe the positioning arm 228 beginning to buckle, bend, or otherwise deform upon engagement (i.e., pressing) with the distal contact surface 38. Therefore, contact with the positioning arm 228 can be identified by tactile feedback and / or visually from fluoroscopy or other image guidance.

[0238] In some embodiments, before the full expansion of the artificial valve 100, the positioning arm 228 may optionally be retracted into the nose cone shaft lumen 222. Optionally, after the full expansion of the artificial valve 100, the balloon 212 (if used) may be deflated to a reduced diameter, and the catheter delivery device 202 j The artificial valve 100 can be removed from the patient and left implanted inside the natural valve 20.

[0239] Figures 14A and 14B show an exemplary delivery assembly 200. k This shows the delivery assembly 200. k This is an exemplary implementation of the delivery assembly 200, and therefore the delivery assembly 200 k Delivery device 202 kHowever, it includes all the configurations described for the delivery assembly 200 throughout this disclosure, except that it further includes one or more positioning arms 240 that extend proximal to the nose cone 236 and are configured to transition between a compressed state and an unfolded or free state. The artificial valve 100 is shown in Figures 14A-14B, but for clarity, it is shown without any soft components such as skirts or leaflets.

[0240] Any reference to multiple forms of positioning arms 240' in this disclosure may, unless otherwise stated, refer to a single positioning arm 240. Each positioning arm 240 includes a fixed end 242 attached to the nose cone 236 by adhesive, welding, suture, etc., and a free end 244 on the opposite side. In some embodiments, the positioning arms 240 are connected at their fixed ends 242 to the proximal end 238 of the nose cone, as shown.

[0241] Optionally, the tension member 246 or tether may be connected to the positioning arm 240. For example, the distal end 248 of the tension member may be attached to the free end 244 of the positioning arm 240 by tying, gluing, or other means, as an optional configuration. The tension member 246 or tether may optionally be in the form of a pull wire, cable, string, suture, and similar. Optionally, the number of tension members 246 may match the number of positioning arms 240. The proximal end of the tension member 246 (not shown) may optionally extend to the handle 204 and be operated by a knob 206 to apply or release tension therefrom. As shown in Figure 14A, when the tension member 246 is subjected to tension, the positioning arm can be forced to take on a relatively straight configuration substantially parallel to the central longitudinal axis Ca and / or parallel to the nose cone shaft 220, as shown in Figure 14A.

[0242] The positioning arm 240 may be configured such that, for example, its shape can be arbitrarily set by heat treatment, and when the tension is released from the tension member 246, the positioning arm 240 can open radially from the central longitudinal axis Ca, and as a result, the free end 244 can be positioned radially away from the nose cone shaft 220 and can be generally oriented laterally and proximal in the free or deployed state.

[0243] Delivery Assembly 200 k As an optional configuration, the prosthesis may advance from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. The tension member is kept constant during delivery, as shown in Figure 14A, and can approximate the free end 244 toward the nose cone shaft 220, keeping the positioning arm 240 in a relatively linearly compressed state before reaching the implantation site (for example, parallel to the central longitudinal axis Ca and / or the distal portion 224 of the nose cone shaft). The prosthesis valve 100 advances so that its inlet portion is located within the left ventricle 32, and the distal portion 224 of the nose cone shaft extends beyond the valve 100 so that the free end 244 of the positioning arm 240 is positioned distal to the inlet end 106 of the valve 100.

[0244] At this stage, as shown in Figure 14B, the tension can be optionally released from the tension member 246 so that the positioning arm 240 can spring radially outward to its pre-formed free state with its free end 244 positioned away from the nose cone shaft 220. The clinician can control the tension of the tension member 246 and optionally release only a portion of the tension sufficient to align the free end 244 with the distal contact surface 38. Although two positioning arms 240 are illustrated in Figures 14A-14B, it will be understood that any other number, such as one positioning arm 240 or three or more positioning arms 240, is also conceivable.

[0245] Using tactile feedback from the positioning arm 240, produced by contact between the free end 244 and the distal contact surface 38, the clinician can manipulate the prosthetic valve 100 axially in a manner similar to that described above with respect to positioning the valve 100 relative to the elongated positioning member 250, to position the inlet end 104 at a desired position relative to the surface of the annular portion 24 that is contacted by the free end 244 of the positioning arm 240. Once the prosthetic valve 100 is positioned at the desired location, with respect to the imaged portion of the free end 244 of the positioning arm 240, corresponding to the natural annular portion 24, the clinician can optionally inflate the expansion balloon 212 or otherwise inflate it (e.g., via removal of a suppressor sheath or capsule in the case of a self-inflating valve, or by operating a mechanical actuator in the case of a mechanically expandable valve) to expand / position the prosthetic valve 100 within the natural annular portion 24. The positioning arm 240 may be configured to be arbitrarily pre-formed to take an arch shape in the free state, as shown in the figure.

[0246] During the expansion of the artificial valve, the positioning arm 240 remains engaged with (for example, pressed against) the distal contact surface 38, and optionally, during the implantation procedure, the delivery assembly 200 k This absorbs at least a portion of the force applied to the molar flap 20.

[0247] In some embodiments, the positioning arm 240 may be relatively prominent under applicable imaging-guided modalities such as fluoroscopy, echocardiography, and / or other imaging methods. As mentioned above, in some embodiments, the positioning arm 240 can be optionally fabricated from a shape-memory material such as nitinol. Since nitinol is sometimes difficult to see under radiography, radiopaque markers (such as gold) may be added, or nitinol may be mixed with a radiopaque material to be easily identifiable under radiography during the procedure. Thus, in some embodiments, the positioning arm 240 is fabricated from a radiopaque material or includes radiopaque markers. This can, in some cases, help in identifying contact between the positioning arm 240 and the contact surface 38. For example, when using radiography or other suitable imaging techniques, a clinician may observe the positioning arm 240 beginning to buckle, bend, or otherwise deform when it engages with (i.e., is pressed against) the distal contact surface 38. Therefore, contact with the positioning arm 240 can be identified by tactile feedback and / or visually by fluoroscopy or other image guidance.

[0248] In some embodiments, before the full expansion of the artificial valve 100, tension can be optionally reapplied to the tension member 246 to return the tension member to a compressed configuration. As an optional configuration, the nose cone 236 may be configured to be distally translated before the tension member 246 is re-tensioned. Optionally, after the full expansion of the artificial valve 100, the balloon 212 (if used) can be deflated to a reduced diameter, and then the catheter delivery device 202 k The artificial valve 100 can be removed from the patient and left implanted inside the natural valve 20.

[0249] Figure 15 shows an exemplary artificial valve 100 deployed within a natural artificial valve 20. l The delivery assembly 200 supporting the artificial valve 100 is shown. l This is an exemplary implementation of the artificial valve 100, and therefore the artificial valve 100 l Outer skirt 150 lHowever, it includes all the configurations described throughout this disclosure for the artificial valve 100, except that it further includes a circumferential mesh 150 configured to transition between a compressed state and an expanded free state.

[0250] Outer skirt 150 l The circumferential mesh 150 may optionally include a base layer 146 extending from the outer skirt inlet end 144 to the outer skirt outlet end 142, and the circumferential mesh 150 may be, for example, sutured or otherwise attached to the base layer 146. Optionally, the base layer 146 may be connected (e.g., sutured) to the frame 102. The circumferential mesh 150 may extend from the distal end 154 to the proximal end 152. In some embodiments, the distal end 154 is aligned with or positioned close to the outer skirt inlet end 144, and the proximal end 152 is optionally distal to the outer skirt outlet end 142. In some embodiments, the circumferential mesh 150 extends around the inlet portion of the frame 102 such that the distal end 154 is aligned with or positioned close to the inlet end 106.

[0251] The circumferential mesh 150 may optionally include a braided flexible material. The circumferential mesh 150 may optionally be formed from a shape memory material such as nitinol and, if not limited by an outer covering element such as a sheath or capsule, may be pre-formed so that the circumferential mesh 150 extends radially away from the frame 102.

[0252] As an optional configuration, the delivery assembly 200 can be advanced from the ascending aorta 26 toward the implantation site, such as the natural aortic valve 20. l As an optional configuration, the circumferential mesh 150 is also held in a crimped or compressed state before reaching the transplant site, and the frame 102 and valve 100 are also held in a compressed state. lThe valve may be configured to be generally flattened between a capsule or sheath (such as the outer delivery shaft 208, or one of the capsules 270, 274 described above) that holds the valve. The valve advances so that its inlet portion is within the left ventricle 32, at which point the artificial valve 100 l This is achieved by advancing distally to it, and / or by valve 100 l By housing the sheath or capsule, it can be exposed from the sheath or capsule.

[0253] This allows the circumferential mesh 150 to expand into its free, pre-formed state, radially extending outward away from the frame 102. The outer diameter of the circumferential mesh 150 is set so that a sufficient portion of the circumferential mesh 150 is positioned below the contact surface 38, and as a result, when in contact with the contact surface 38, a suitable portion of the circumferential mesh 150 passes through the annular portion 24 of the artificial valve 100. l It resists further proximal displacement. In some embodiments, the radial distance between the frame 102 (or base layer 146) and the outermost edge of the circumferential mesh, as assumed by the extended free state circumferential mesh 150, is greater than half the diameter of the frame 102 in the extended configuration.

[0254] In some embodiments, the radial distance assumed by the circumferential mesh 150 in its expanded free state is at least as large as the diameter of the frame 102 in its expanded configuration. The radial distance that the circumferential mesh 150 can expand is the diameter of the artificial valve 100 l When the prosthetic valve 100 is released from the capsule (or sheath), a sufficient contact area is provided by the circumferential mesh 150 for contact with the distal contact surface 38, while the prosthetic valve 100 lThe circumferential mesh is selected to be large enough so that it remains fully or at least partially compressed. When the outermost edge of the circumferential mesh 150 contacts and presses against the side wall of the left ventricle 32 as the prosthetic valve expands, the circumferential mesh 150 may be radially compressed between the frame 102 and the surrounding anatomical wall, allowing the circumferential mesh 150 to have a narrower radial distance between the frame and its outermost edge without hindering the expansion of the prosthetic valve.

[0255] When the circumferential mesh 150 is spaced distally from the distal contact surface 38, the artificial valve 100 l As an optional configuration, the circumferential mesh 150 may be pulled proximally to approximate the annular portion 24 so that the proximal surface of the circumferential mesh 150 contacts the distal contact surface 38. In some embodiments, as an optional configuration, the artificial valve 100 l This configuration, which pulls the annulus 24 proximally while simultaneously expanding it at least partially, can help position the circumferential mesh 150 further apart radially to align it with the distal contact surface 38.

[0256] Using tactile feedback from the circumferential mesh 150 created by contact with the distal contact surface 38, the clinician positions the inlet end 104 at a desired position relative to the surface of the annular portion 24 that is in contact with the circumferential mesh 150, in a manner similar to that described above with respect to the positioning of the valve 100 relative to the elongated positioning member 250. l It can be operated in the axial direction. Artificial valve 100 l However, if positioned as desired relative to the imaged circumferential mesh 150 corresponding to the natural annular portion 24, the clinician may optionally inflate the expansion balloon 212 or, by other means (e.g., by removing the restraining sheath or capsule in the case of a self-expandable valve, or by operating a mechanical actuator in the case of a mechanically expandable valve), the artificial valve 100 within the natural annular portion 24. lThis can result in expansion / positioning. During expansion of the artificial valve, the positioning support 160 remains engaged with (e.g., pressed against) the distal contact surface 38 and optionally absorbs at least a portion of the force applied to the molar valve 20 by the delivery assembly 200 during the implantation procedure.

[0257] In some embodiments, the circumferential mesh 150 may be relatively prominent under applicable image-guided modalities such as fluoroscopy, echocardiography, and / or other imaging methods. As mentioned above, in some embodiments, the circumferential mesh 150 can be optionally fabricated from a shape-memory material such as nitinol. Since nitinol is sometimes difficult to see under radiography, radiopaque markers (such as gold) may be added, or nitinol may be mixed with a radiopaque material to be easily identifiable under radiography during the procedure. Thus, in some embodiments, the circumferential mesh 150 is fabricated from a radiopaque material or contains radiopaque markers. This can, in some cases, help in identifying contact between the circumferential mesh 150 and the contact surface 38. For example, when using fluoroscopy or other suitable imaging techniques, the clinician may observe that the circumferential mesh 150 begins to compress axially or otherwise begin to deform when engaged (i.e., pressed) with the distal contact surface 38. Therefore, contact with the circumferential mesh 150 can be identified by tactile feedback and / or visually by fluoroscopy or other image guidance.

[0258] Some of the positioning members and solutions disclosed herein are designed to have a tip or contact surface (configured to contact a contact surface such as surface 36 or 38) at a specific axial distance from the inlet end 106 of the artificial valve 100, so that when pressed against the contact surface, the inlet end 106 remains in a desired axial position relative to the annular portion 24. As the artificial valve expands radially, the length between the inlet end and the outlet end typically decreases. Artificial valve 100 shown in Figures 1A-1B aConventional artificial valves such as the one described above have traditionally been shortened so that the inlet end 106 moves axially toward the outlet end 104, thereby creating a longer outlet vertical support 114 for the frame 102 a This can result from higher rigidity in the outflow region.

[0259] Figure 16 shows an exemplary artificial valve 100. m Frame 102 m This indicates artificial valve 100 m This is an exemplary implementation of the artificial valve 100, and therefore the artificial valve 100 m Frame 102 m However, it includes all the configurations described throughout this disclosure for the artificial valve 100, except that it includes the inlet vertical support 116, which is the longest vertical support 112 of the frame. m For clarity, it is shown in Figure 16 without any soft components such as a skirt or valve leaflets.

[0260] In some embodiments, frame 102 m The vertical support 112 comprises an outflow vertical support 114 having length Lov and an inflow vertical support 116 having length Liv, so that the length Liv of the inflow vertical support 116 is greater than the length Lov of the outflow vertical support 114 (i.e., Liv > Lov), as shown in Figure 16. The longer inflow vertical support 116 is connected to valve 100 m As it expands radially and shortens axially, the outlet end 104 tends to move toward the inlet end 106, and advantageously, the artificial valve 100 keeps the inlet end 106 fixed in place relative to the natural annular portion 24. m This results in greater overall rigidity in the inflow section.

[0261] In some embodiments, the artificial valve 100 may optionally include only an inlet vertical support 116 without any outlet support, which would result in a similar effect of the outlet end 104 moving toward the inlet end 106 during the shortening of the frame 102, due to the increased rigidity of the inlet end of the frame.

[0262] Artificial valve 100 with longer inflow vertical support 116 m Features include the delivery assembly 200 b , 200 c , 200b, 200 d , 200 e , 200 h , 200 i , 200 j , and / or 200 k , and artificial valve 100 i and / or 100 l It should be understood that any of the components and parts of the exemplary delivery assembly 200 disclosed herein, including those mentioned above, can be optionally used in combination with each other. Similarly, any other components or parts of either the exemplary delivery assembly 200 and / or the artificial valve 100 can be used in combination with each other.

[0263] Some examples of the disclosed technology Some embodiments relating to the above-described technology are listed below. It should be noted that a single individual configuration in one embodiment, or two or more configurations in a combination in that embodiment, and optionally a combination with one or more configurations in one or more of the following embodiments, are also further embodiments that fall within the disclosure of this application.

[0264] Example 1. A delivery assembly comprising: an artificial valve having a frame movable between a radially compressed configuration and a radially expanded configuration; and a delivery device comprising: a handle; an outer delivery shaft extending distally from the handle; at least one elongated positioning member extending through the outer delivery shaft and movable axially relative to the outer delivery shaft; and at least one sensor attached to the at least one elongated positioning member, wherein the at least one elongated positioning member is configured to position its distal end radially outward with respect to the artificial valve and axially distal with respect to the outflow end of the frame.

[0265] Example 2. Any embodiment of this specification, in particular the delivery assembly described in Example 1, wherein at least one elongated positioning member comprises a conductive material and is configured to function as a communication device through which an electrical signal acquired by a corresponding sensor can be delivered.

[0266] Example 3. Any embodiment of this specification, in particular the delivery assembly described in Example 2, wherein at least one elongated positioning member is insulated along its length and exposed in the sensor mounting area.

[0267] Example 4. A delivery assembly according to any embodiment of the Spec, in particular any one of Examples 1 to 3, wherein at least one sensor is oriented distally.

[0268] Example 5. Any embodiment of this specification, in particular the delivery assembly described in Example 4, wherein at least one sensor is attached to the distal end of an elongated positioning member.

[0269] Example 6. Any embodiment of the specification, in particular any one of Examples 1 to 3, wherein at least one sensor is oriented laterally.

[0270] Example 7. Any embodiment of this specification, in particular the delivery assembly described in Example 6, wherein at least one sensor is attached to a portion of an elongated positioning member configured to be positioned distal to the outlet end.

[0271] Example 8. Any embodiment of this specification, in particular the delivery assembly described in Example 7, wherein at least one sensor is configured to face radially away from the artificial valve when positioned distal to the outflow end.

[0272] Example 9. Any embodiment of this specification, in particular the delivery assembly described in Example 7, wherein at least one sensor is configured to face radially toward the artificial valve when positioned distal to the outflow end.

[0273] Example 10. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 4 to 9, wherein the sensor is a force sensor.

[0274] Example 11. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 1 to 3, wherein the at least one sensor comprises at least two sensors connected to at least one elongated positioning member.

[0275] Example 12. Any embodiment of this specification, in particular the delivery assembly according to Example 11, wherein the at least two sensors are spaced apart from each other in the axial direction.

[0276] Example 13. Any embodiment of this specification, in particular the delivery assembly according to Example 12, wherein at least one of the at least two sensors is mounted on a portion of an elongated positioning member configured to be positioned distal to the outlet end, and the other one of the at least two sensors is mounted on a portion of an elongated positioning member configured to remain proximal to the outlet end.

[0277] Example 14. Any embodiment of this specification, in particular the delivery assembly according to Example 12, wherein the at least two sensors are attached to a portion of an elongated positioning member configured to remain proximal to the outflow end during expansion of the artificial valve within the natural annular portion.

[0278] Example 15. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 11 to 14, wherein at least two of the sensors are pressure sensors.

[0279] Example 16. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 1 to 3, wherein the at least one sensor comprises three or more flow sensors.

[0280] Example 17. Any embodiment of this specification, in particular the delivery assembly described in Example 16, wherein the flow sensor is attached to a portion of an elongated positioning member configured to remain proximal to the outlet end during expansion of an artificial valve within a natural annular portion.

[0281] Example 18. Any embodiment of this specification, in particular any one of Examples 1 to 3, wherein the delivery assembly further comprises a second pressure sensor attached to another component of the delivery assembly, wherein the at least one sensor comprises a first pressure sensor, and the delivery assembly further comprises a second pressure sensor attached to another component of the delivery assembly.

[0282] Example 19. Any embodiment of this specification, in particular the delivery assembly described in Example 18, wherein the first pressure sensor is attached to a portion of the elongated positioning member configured to remain proximal to the outlet end during expansion of the artificial valve within the natural annular portion.

[0283] Example 20. Any embodiment of this specification, in particular the delivery assembly according to Example 19, wherein the second pressure sensor is mounted on a portion of another component of the delivery assembly configured to remain distal to the first pressure sensor during expansion of the artificial valve within the natural annular portion.

[0284] Example 21. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 18 to 20, wherein another component of the delivery assembly to which the second sensor is attached is axially movable relative to the first pressure sensor.

[0285] Example 22. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 18 to 21, wherein the second pressure sensor is attached to the artificial valve.

[0286] Example 23. Any embodiment of this specification, in particular the delivery assembly according to Example 22, wherein the second pressure sensor is mounted on a portion of the artificial valve closer to the inlet end of the frame than to the outlet end.

[0287] Example 24. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 18 to 21, wherein the second pressure sensor is attached to the nose cone shaft of the delivery device.

[0288] Example 25. Any embodiment of this specification, in particular the delivery assembly according to Example 24, wherein the second pressure sensor is attached to the distal end of the nose cone shaft.

[0289] Example 26. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 18 to 21, wherein the second pressure sensor is mounted on the nose cone of the delivery device.

[0290] Example 27. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 18 to 21, wherein the second pressure sensor is attached to the balloon catheter of the delivery device.

[0291] Example 28. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 1 to 27, wherein the distal end of at least one elongated positioning member is non-traumatic.

[0292] Example 29. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 1 to 28, wherein the at least one elongated positioning member comprises a radiopaque material.

[0293] Example 30. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 1 to 28, wherein the at least one elongated positioning member comprises a loop, the loop defining two side segments and a bottom curved segment.

[0294] Example 31. Any embodiment of this specification, in particular the delivery assembly of Example 30, wherein the loop is formed of a shape memory material configured to take a predetermined shape when not tightened inside the outer delivery shaft.

[0295] Example 32. A delivery assembly of any embodiment of this specification, in particular of Example 30 or 31, wherein at least one sensor is mounted on the bottom curved segment.

[0296] Example 33. A delivery assembly of any embodiment of this specification, in particular of Example 30 or 31, wherein at least one sensor is attached to one of the side segments.

[0297] Example 34. Any embodiment of this specification, in particular any one of Examples 30-33, further comprising one or more radiopaque markers.

[0298] Example 35. Any embodiment of this specification, in particular any one of Examples 1 to 34, further comprising a valve structure including a plurality of valve leaflets arranged within the frame and configured to regulate the flow of blood through the artificial valve, the delivery assembly according to any embodiment of this specification.

[0299] Example 36. Any embodiment of this specification, in particular the delivery assembly described in Example 35, wherein the plurality of valve leaflets include three valve leaflets.

[0300] Example 37. A method comprising the steps of advancing a delivery assembly, which includes a delivery device that carries an artificial valve in a radially compressed configuration, onto a natural heart valve; extending at least one elongated positioning member of the delivery device distally through an outer delivery shaft of the delivery device until the distal end of the at least one elongated positioning member interacts with the proximal contact surface of the natural heart valve; acquiring a measurement signal from at least one sensor attached to the at least one elongated positioning member; and expanding the artificial valve within the annular portion of the natural heart valve while the distal end of the at least one elongated positioning member is radially separated from the artificial valve.

[0301] Example 38. Any embodiment of this specification, in particular the method of Example 37, wherein the step of expanding the artificial valve in the annular portion includes the step of advancing the artificial valve from the outer delivery shaft into the annular portion.

[0302] Example 39. Any embodiment of this specification, in particular the method of Example 38, wherein the step of advancing the artificial valve is performed simultaneously with the step of extending at least one elongated positioning member.

[0303] Example 40. Any embodiment of this specification, in particular the method of Example 38, wherein the step of advancing the artificial valve is followed by the step of extending at least one elongated positioning member.

[0304] Example 41. A method relating to any embodiment of this specification, in particular to the method of Example 38, wherein the step of expanding the artificial valve within the annular portion includes the steps of partially expanding the artificial valve to a diameter smaller than the diameter of the annular portion, pausing the valve expansion, and fully expanding the artificial valve relative to the natural annular portion, wherein the method further includes the step of retracting the at least one elongated positioning member from the natural heart valve after partially expanding the artificial valve and before fully expanding the artificial valve.

[0305] Example 42. The method according to any embodiment of this specification, in particular any one of Examples 38 to 41, wherein the step of stretching at least one elongated positioning member includes the step of identifying the position of the proximal contact surface of a natural heart valve by monitoring at least one elongated positioning member under fluorescence imaging.

[0306] Example 43. Any embodiment of this specification, particularly the method of Example 42, wherein the step of advancing the artificial valve includes the step of positioning the inlet end of the artificial valve in an axial position relative to at least one elongated positioning member, while monitoring both the frame of the artificial valve and at least one elongated positioning member under fluoroscopy.

[0307] Example 44. Any embodiment of this specification, in particular the method of any one of Examples 37 to 43, wherein the at least one sensor is a distally oriented force sensor configured to contact a proximal contact surface.

[0308] Example 45. Any embodiment of this specification, in particular the method of Example 44, wherein the step of acquiring a measurement signal is performed in the extension of at least one elongated positioning member through an outer delivery shaft, and the interaction between at least one elongated positioning member and a proximal contact surface is identified by a force measured by a force sensor indicating contact with the proximal contact surface.

[0309] Example 46. The method according to any one of Examples 37 to 43, wherein the at least one sensor is a laterally oriented force sensor positioned between the artificial valve and the inner wall of the molar root during expansion of the artificial valve within the annular portion.

[0310] Example 47. Any embodiment of this specification, in particular the method of Example 46, wherein the step of acquiring a measurement signal is performed during expansion of the artificial valve, and the measurement signal indicates the force applied by the artificial valve to the annular portion.

[0311] Example 48. Any embodiment of this specification, in particular the method of Example 46 or 47, wherein the force sensor is oriented toward the inner wall of the root of the molar tooth.

[0312] Example 49. The method of any embodiment of this specification, in particular of Example 46 or 47, wherein the force sensor is oriented toward the artificial valve.

[0313] Example 50. The method according to any one of Examples 37 to 49, wherein at least one elongated positioning member is radiopaque, and the step of stretching at least one elongated positioning member includes, under image guidance, the step of identifying deformation of the elongated positioning member due to contact with a proximal contact surface.

[0314] Example 51. A delivery assembly comprising: an artificial valve having a frame movable between a radially compressed configuration and a radially expanded configuration; and a delivery device comprising: a handle; an outer delivery shaft extending distally from the handle; a positioning balloon movable between a contracted state and an expanded state; and an expansion tube connected to the positioning balloon and in fluid communication with the positioning balloon, wherein the expansion tube extends through the outer delivery shaft and is axially movable relative to the outer delivery shaft, and the expansion tube is configured to position the positioning balloon radially outward relative to the artificial valve such that at least a portion of the positioning balloon extends axially distally relative to the outflow end of the frame.

[0315] Example 52. Any embodiment of this specification, in particular the delivery assembly of Example 51, wherein the distal end of the positioning balloon forms a non-traumatic surface when inflated.

[0316] Example 53. Any embodiment of this specification, particularly the delivery assembly according to Example 51 or 52, wherein the expansion tube is configured to deliver expansion fluid into a positioning balloon to transition the balloon to an inflated state, and to discharge the expansion fluid from the positioning balloon when the positioning balloon transitions to a deflated state.

[0317] Example 54. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 51 to 53, wherein the positioning balloon is configured to deflate in response to compression between the prosthetic valve and the molar root wall surrounding the prosthetic valve when the prosthetic valve is positioned in an inflated state between the prosthetic valve and the molar root wall during expansion of the prosthetic valve.

[0318] Example 55. In the inflated state of the positioning balloon, the internal pressure of the positioning balloon is low enough to allow deformation of the positioning balloon when compressed by the artificial valve during inflation of the artificial valve, as described in any embodiment of this specification, in particular any one of Examples 51 to 54 of the delivery assembly.

[0319] Example 56. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 51 to 55, wherein the balloon comprises a radiopaque material.

[0320] Example 57. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 51 to 56, wherein the artificial valve further comprises a valve structure including a plurality of valve leaflets arranged within a frame and configured to regulate the flow of blood through the artificial valve.

[0321] Example 58. Any embodiment of this specification, in particular the delivery assembly described in Example 57, wherein the plurality of valve leaflets include three valve leaflets.

[0322] Example 59. A delivery assembly comprising an artificial valve having a frame movable between a radially compressed configuration and a radially expanded configuration, a handle, an outer delivery shaft extending distally from the handle, and a stabilizing filter positioned proximal to the artificial valve and configured to transition between a folded state and an unfolded state, wherein the stabilizing filter comprises a plurality of pores.

[0323] Example 60. Any embodiment of this specification, in particular the delivery assembly described in Example 59, wherein the stabilizing filter includes a braided mesh.

[0324] Example 61. A delivery assembly of any embodiment of this specification, particularly of Example 59 or 60, wherein the stabilizing filter is made of a shape memory material configured to self-expand to an unfolded state when not restricted by the outer shaft.

[0325] Example 62. Any of the embodiments described herein, particularly the delivery assembly according to Example 61, wherein the shape memory alloy is nitinol.

[0326] Example 63. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 59 to 62, wherein the maximum pore size is 40 to 300 microns.

[0327] Example 64. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 59 to 62, wherein the average pore size is 40 to 300 microns.

[0328] Example 65. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 59 to 64, wherein the stabilizing filter is mounted on a shaft of the delivery device that is movable in the axial direction through the outer delivery shaft.

[0329] Example 66. Any embodiment of the specification, in particular the delivery assembly according to Example 65, wherein the shaft to which the stabilizing filter is attached is a balloon catheter, and the delivery device further comprises a balloon attached to the balloon catheter.

[0330] Example 67. Any embodiment of this specification, in particular the delivery assembly of Example 66, wherein the stabilizing filter is attached to a portion of the balloon catheter located proximal to the balloon.

[0331] Example 68. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 65-67, wherein the stabilizing filter, in its deployed state, does not include an opening between its outermost diameter and the shaft to which it is mounted, and the opening is larger in size than a pore.

[0332] Example 69. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 65 to 68, wherein the stabilizing filter comprises a radiopaque material.

[0333] Example 70. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 59 to 69, wherein the artificial valve further comprises a valve structure including a plurality of valve leaflets arranged within the frame and configured to regulate the flow of blood through the artificial valve.

[0334] Example 71. The delivery assembly according to any embodiment of this specification, in particular Example 70, wherein the plurality of valve leaflets include three valve leaflets.

[0335] Example 72. A delivery assembly comprising: an artificial valve having a frame that is movable between a radially compressed configuration and a radially expanded configuration, extending between an inlet end and an outlet end, and one or more positioning posts configured to transition between a compressed state and an unfolded state; and a delivery device having a handle, an inner capsule configured to hold the artificial valve therein in the radially compressed configuration, and an outer capsule having an inner diameter larger than the outer diameter of the inner capsule, wherein the one or more positioning posts are configured to extend radially away from the frame in the unfolded state, and the artificial valve, the inner capsule, and the outer capsule are axially movable relative to each other.

[0336] Example 73. Any embodiment of this specification, in particular the delivery assembly according to Example 72, wherein one or more positioning posts are connected at their fixed ends to a joint of the frame closer to the inlet end than to the outlet end.

[0337] Example 74. Any embodiment of this specification, in particular the delivery assembly according to Example 72, wherein one or more positioning posts are connected at their fixed ends to allow the apex of the frame to flow in.

[0338] Example 75. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 74, wherein one or more positioning posts terminate at a non-traumatic free end.

[0339] Example 76. Any embodiment of this specification, in particular the delivery assembly according to Example 75, wherein the free end is configured to be positioned proximal to the inlet end in the deployed state.

[0340] Example 77. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 76, wherein one or more positioning supports are formed from a shape memory material.

[0341] Example 78. Any of the embodiments described herein, particularly the delivery assembly described in Example 77, wherein the shape memory alloy is nitinol.

[0342] Example 79. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 78, wherein one or more positioning supports are integrally formed with the frame.

[0343] Example 80. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 79, wherein the inner capsule comprises one or more slots extending proximal from the distal end of the inner capsule.

[0344] Example 81. Any embodiment of this specification, in particular the delivery assembly of Example 80, wherein the number of slots 78 matches the number of positioning supports.

[0345] Example 82. Any embodiment of this specification, in particular the delivery assembly according to Example 80 or 81, wherein one or more slots are circumferentially aligned with one or more positioning posts.

[0346] Example 83. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 80 to 82, wherein one or more slots are sized to allow the positioning support to extend through them.

[0347] Example 84. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 83, wherein one or more positioning supports are pre-formed to have a curved configuration when unfolded.

[0348] Example 85. Any embodiment of this specification, in particular the delivery assembly described in Example 84, wherein the curved configuration is C-shaped or U-shaped.

[0349] Example 86. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 72 to 85, wherein the positioning support includes a radiopaque marker.

[0350] Example 87. Any embodiment of this specification, in particular any one of Examples 72 to 86, further comprising a valve structure including a plurality of valve leaflets arranged within the frame and configured to regulate the flow of blood through the frame in one direction.

[0351] Example 88. Any embodiment of this specification, in particular the delivery assembly described in Example 87, wherein the plurality of valve leaflets include three valve leaflets.

[0352] Example 89. A delivery assembly comprising an artificial valve having a frame movable between a radially compressed configuration and a radially expanded configuration, wherein the frame extends between an inlet end and an outlet end; and a delivery device comprising a handle; a nose cone shaft extending distally from the handle, defining the lumen of the nose cone shaft and including one or more side openings formed in the distal portion of the nose cone shaft; a nose cone attached to the distal portion of the nose cone shaft; and one or more positioning arms extending through the lumen of the nose cone shaft. A delivery assembly comprising a delivery device including one or more positioning arms configured to transition between a compressed state and an unfolded state, wherein the one or more positioning arms are axially movable relative to the nose cone shaft and the nose cone, configured to assume the compressed state when fully held within the lumen of the nose cone shaft, and to assume the unfolded state when at least a portion thereof extends through the one or more side openings, and the one or more positioning arms are configured to extend radially away from the nose cone shaft in the deployed state.

[0353] Example 90. Any embodiment of this specification, in particular the delivery assembly according to Example 89, wherein one or more positioning arms terminate at a non-traumatic free end.

[0354] Example 91. Any embodiment of this specification, in particular the delivery assembly of Example 90, wherein the free end is configured to be positioned proximal to the inlet end of the frame in the deployed state.

[0355] Example 92. A delivery assembly of any embodiment of this specification, particularly of Example 90 or 91, wherein the free end is configured to be radially offset from the frame when unfolded.

[0356] Example 93. A delivery assembly according to any one of Examples 89 to 92, wherein the nose cone shaft and the artificial valve are axially movable relative to each other so that one or more side openings are positioned distal to the inlet end of the frame.

[0357] Example 94. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 93, wherein one or more positioning arms are formed from a shape memory material.

[0358] Example 95. Any of the embodiments described herein, particularly the delivery assembly described in Example 94, wherein the shape memory alloy is nitinol.

[0359] Example 96. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 95, wherein one or more positioning arms are predetermined to be curved in their extended state.

[0360] Example 97. Any embodiment of this specification, in particular the delivery assembly of Example 96, wherein the curved configuration is C-shaped or U-shaped.

[0361] Example 98. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 97, wherein the number of side openings matches the number of positioning arms.

[0362] Example 99. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 98, wherein one or more side openings are circumferentially aligned with one or more positioning arms.

[0363] Example 100. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 99, wherein one or more side openings are sized to allow the positioning arm to extend through them.

[0364] Example 101. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 100, wherein the delivery assembly further comprises one or more radiopaque markers.

[0365] Example 102. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 89 to 101, further comprising a valve structure including a plurality of valve leaflets arranged within the frame and configured to regulate the flow of blood through the artificial valve.

[0366] Example 103. Any embodiment of this specification, in particular the delivery assembly described in Example 102, wherein the plurality of valve leaflets include three valve leaflets.

[0367] Example 104. A delivery assembly of any embodiment of this specification, particularly of Example 102 or 103, wherein the nose cone shaft extends through an artificial valve between a plurality of valve leaflets.

[0368] Example 105. A delivery assembly comprising an artificial valve having a frame movable between a radially compressed configuration and a radially expanded configuration, wherein the frame extends between an inlet end and an outlet end; a delivery device comprising a handle; a nose cone shaft extending distally from the handle, wherein the nose cone shaft defines a lumen of the nose cone shaft and includes one or more side openings formed in the distal portion of the nose cone shaft; a nose cone attached to the distal portion of the nose cone shaft at the proximal end of the nose cone; and one or more attached to the nose cone at its fixed end and extending proximal therefrom to its free end. A delivery assembly comprising: a delivery device comprising: one or more positioning arms configured to transition between a compressed state and an unfolded state; and one or more tension members attached to the free ends of the one or more positioning arms and extending proximal therefrom, wherein the one or more positioning arms are configured to assume the compressed state when the one or more tension members attached thereto are subjected to tension, and to assume the unfolded state when the tension is released from the one or more tension members, and the one or more positioning arms are configured to extend radially away from the nose cone and the nose cone shaft in the deployed state.

[0369] Example 106. Any embodiment of this specification, in particular the delivery assembly according to Example 105, wherein the free ends of one or more positioning arms are non-traumatic.

[0370] Example 107. A delivery assembly of any embodiment of this specification, particularly of Example 105 or 106, wherein the free end is configured to be positioned proximal to the inlet end of the frame in the deployed state.

[0371] Example 108. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 107, wherein the free end is configured to be radially offset from the frame when unfolded.

[0372] Example 109. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 108, wherein the nose cone and artificial valve are axially movable relative to each other so that one or more free ends are positioned distal to the inlet end of the frame.

[0373] Example 110. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 109, wherein one or more positioning arms are formed from a shape memory material.

[0374] Example 111. Any of the embodiments described herein, particularly the delivery assembly described in Example 110, wherein the shape memory alloy is nitinol.

[0375] Example 112. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 111, wherein one or more positioning arms are predetermined to be curved in their extended state.

[0376] Example 113. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 112, wherein the number of tension members matches the number of positioning arms.

[0377] Example 114. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 113, wherein one or more tension members extend from the free end of the positioning arm through one or more side openings into the lumen of the nose cone shaft.

[0378] Example 115. Any embodiment of this specification, in particular Example 114, of the delivery assembly, wherein one or more tension members extend into the lumen of the nose cone shaft from the side opening to the handle.

[0379] Example 116. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 115, wherein one or more side openings are circumferentially aligned with one or more free ends of a positioning arm.

[0380] Example 117. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 116, wherein one or more side openings are sized to allow the tension member to stretch through them.

[0381] Example 118. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 117, wherein the one or more alignment arms include radiopaque markers.

[0382] Example 119. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 118, wherein one or more positioning arms are attached at their fixed ends to the proximal end of the nose cone.

[0383] Example 120. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 119, wherein the one or more tension members include at least one of wires, strings, sutures, and / or cables.

[0384] Example 121. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 105 to 120, wherein one or more positioning arms are parallel to the nose cone shaft in a compressed state.

[0385] Example 122. An artificial heart valve according to any embodiment of this specification, in particular any one of Examples 105 to 121, wherein the artificial valve further comprises a valve structure including a plurality of valve leaflets arranged within a frame and configured to regulate the flow of blood through the artificial valve.

[0386] Example 123. Any embodiment of this specification, in particular the delivery assembly described in Example 122, wherein the plurality of valve leaflets include three valve leaflets.

[0387] Example 124. Any embodiment of this specification, in particular Example 122 or 123, wherein the nose cone shaft extends through an artificial valve between a plurality of valve leaflets, the delivery assembly.

[0388] Example 125. A delivery assembly comprising an artificial valve, an artificial valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, and an outer skirt disposed around the frame, wherein the outer skirt includes a circumferential mesh configured to transition between a compressed state and an expanded free state; and a delivery device comprising a capsule, wherein the circumferential mesh is configured to take the compressed state when the artificial valve is held within the capsule, and to take the expanded free state when the artificial valve is unfolded from the capsule.

[0389] Example 126. Any embodiment of this specification, in particular the delivery assembly described in Example 125, wherein the outer skirt further comprises a base layer, the base layer is attached to a frame, and a circumferential mesh is attached to the base layer.

[0390] Example 127. The method according to any embodiment of this specification, in particular to one of Examples 125 or 126, wherein the circumferential mesh extends around the inlet of the frame.

[0391] Example 128. The circumferential mesh is a delivery assembly according to any embodiment of this specification, in particular any one of Examples 125 to 127, comprising a flexible braided material.

[0392] Example 129. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 125-128, wherein the circumferential mesh is made of a shape memory material configured to self-expand to an expanded free state when not restricted by the capsule.

[0393] Example 130. Any of the embodiments described herein, particularly the delivery assembly described in Example 129, wherein the shape memory alloy is nitinol.

[0394] Example 131. A delivery assembly according to any embodiment of this specification, in particular any one of Examples 125-130, wherein, in an extended free state, the radial distance defined by the circumferential mesh between the frame and the outermost edge of the circumferential mesh is greater than the radius defined by the frame in the extended configuration of the frame.

[0395] Example 132. Any embodiment of this specification, in particular the delivery assembly described in Example 131, wherein the radial distance of the expanded free-state circumferential mesh is at least as large as the diameter of the frame in the expanded configuration of the frame.

[0396] Example 133. The circumferential mesh is a delivery assembly according to any embodiment of this specification, in particular any one of Examples 125 to 132, comprising a radiopaque material.

[0397] Example 134. Any embodiment of this specification, in particular any one of Examples 125 to 133, further comprising a valve structure including a plurality of valve leaflets arranged within a frame and configured to regulate the flow of blood through the artificial valve, the delivery assembly according to any one of these embodiments.

[0398] Example 135. Any embodiment of this specification, in particular the delivery assembly described in Example 134, wherein the plurality of valve leaflets include three valve leaflets.

[0399] Example 136. An artificial valve comprising a frame that is movable between a radially compressed configuration and a radially expanded configuration, extending between an inlet end and an outlet end, and including a plurality of intersecting struts, wherein the plurality of struts include a plurality of angled struts, a plurality of vertical struts, a plurality of inlet vertical struts defined between cells of the frame extending from the inlet end, and a plurality of outlet vertical struts defined between cells of the frame extending from the outlet end, wherein the inlet vertical struts define an inlet strut length greater than the outlet strut length defined by the inlet vertical struts.

[0400] Example 137. Any embodiment of this specification, in particular the artificial valve according to Example 136, further comprising a valve structure including a plurality of valve leaflets arranged within a frame and configured to regulate the flow of blood through the artificial valve.

[0401] Example 138. The artificial valve according to any embodiment of this specification, in particular Example 137, wherein the multiple valve leaflets include three valve leaflets.

[0402] Example 139. An artificial valve according to any embodiment of this specification, in particular Example 137 or 138, further comprising a plurality of commitments formed between adjacent valve leaflets, wherein the plurality of commitments are coupled to at least a portion of a plurality of outflow vertical supports.

[0403] Example 140. An artificial valve according to any embodiment of this specification, particularly according to any one of Examples 137 to 139, wherein the cells extending from the outflow end and the cells extending from the inflow end define a hexagonal opening.

[0404] Example 141. Any embodiment of this specification, in particular Example 140, of the artificial valve, wherein the hexagonal opening of the cell extending from the inlet end is larger than the hexagonal opening of the cell extending from the outlet end.

[0405] Example 142. An artificial valve according to any embodiment of this specification, particularly according to any one of Examples 137 to 141, further comprising an outer skirt provided around the outer surface of the frame.

[0406] Example 143. An artificial valve according to any embodiment of this specification, particularly according to any one of Examples 137 to 142, further comprising an inner skirt provided around the inner surface of the frame.

[0407] Example 144. An artificial valve according to any embodiment of this specification, in particular any one of Examples 137 to 143, wherein the frame comprises at least one additional row of diamond-shaped cells positioned between cells extending from the inlet end and cells extending from the outlet end.

[0408] Example 145. An artificial valve according to any embodiment of this specification, in particular any one of Examples 137 to 144, wherein the frame comprises a cobalt-chromium alloy.

[0409] Example 146. An artificial valve according to any one of Examples 137 to 145, wherein the frame further comprises a plurality of inlet shafts at the inlet end and a plurality of outlet shafts at the outlet end, and each inlet vertex is angularly positioned between two of the plurality of inlet vertical supports, and each outlet vertex is angularly positioned between two of the plurality of outlet vertical supports.

[0410] Example 147. An artificial valve according to any one of Examples 137 to 146, wherein the angled support is angled with respect to the central longitudinal axis of the frame, and the vertical support is parallel to the central longitudinal axis.

[0411] Example 148. A delivery assembly according to any embodiment of this specification, in particular one of Examples 1 to 36 or 39 to 135, wherein the frame comprises a plurality of columns, the plurality of columns comprising a plurality of angled columns, a plurality of vertical columns comprising a plurality of inlet vertical columns defined between cells of the frame extending from the inlet end of the frame, and a plurality of outlet vertical columns defined between cells of the frame extending from the outlet end of the frame, wherein the inlet vertical columns define an inlet column length greater than the outlet column length defined by the inlet vertical columns.

[0412] Example 149. Any embodiment of this specification, in particular the delivery assembly described in Example 148, wherein cells extending from the outflow end and cells extending from the inflow end define a hexagonal opening.

[0413] Example 150. Any embodiment of this specification, in particular the delivery assembly described in Example 149, wherein the hexagonal opening of the cell extending from the inlet end is larger than the hexagonal opening of the cell extending from the outlet end.

[0414] Example 151. The method, comprising: advancing a delivery assembly, which includes a delivery device that carries an artificial valve in a radially compressed configuration, onto a natural heart valve; contacting the contact surface of the natural heart valve with at least one positioning member of the delivery device; identifying the axial position of the annular portion of the natural heart valve by monitoring the at least one positioning member under fluoroscopy; positioning the inlet end of the artificial valve axially with respect to the at least one positioning member while monitoring both the frame of the artificial valve and the at least one positioning member under fluoroscopy; and expanding the artificial valve within the annular portion.

[0415] Example 152. Any embodiment of this specification, in particular the method of Example 151, wherein the artificial valve is axially movable with respect to at least one positioning member.

[0416] Example 153. Any embodiment of this specification, in particular the method of Example 152, wherein the step of positioning the inlet end of the artificial valve includes the step of moving the artificial valve axially relative to at least one positioning member while maintaining the position of at least one positioning member in contact with a contact surface.

[0417] Example 154. Any embodiment of this specification, particularly the method of any of Examples 151 to 153, wherein the contact surface is the proximal contact surface of a natural heart valve.

[0418] Example 155. The method according to any embodiment of this specification, in particular any one of Examples 151 to 153, wherein the contact surface is the distal contact surface of a natural heart valve.

[0419] Example 156. The method of any embodiment of this specification, in particular any one of Examples 151 to 155, wherein the step of contacting the contact surface includes a step of confirming contact between at least one positioning member and the contact surface using tactile feedback from at least one positioning member.

[0420] While certain configurations of this disclosure are described in the context of various individual examples for clarity, it will be understood that they may also be provided in combination in a single example. Conversely, while various configurations of this disclosure are described in the context of a single example for brevity, they may also be provided individually, in any preferred subcombination, or as suitably provided in any other example of this disclosure. No configuration described in the context of an example should be considered an essential configuration of that example unless expressly designated so.

[0421] Given the many possible examples to which the principles of this disclosure may apply, it will be recognized that the examples provided are merely preferred examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the following claims. Accordingly, everything contained within those claims and their spirit is asserted.

Claims

1. A delivery assembly, An artificial valve having a movable frame between a radially compressed configuration and a radially expanded configuration, A delivery device, The handlebars and An external delivery shaft extending distally from the handle, At least one elongated positioning member that extends through the outer delivery shaft and is movable in the axial direction relative to the outer delivery shaft, A delivery device including at least one sensor attached to the at least one elongated positioning member, Includes, A delivery assembly in which at least one elongated positioning member is configured to position its distal end radially outward with respect to the artificial valve and axially distal with respect to the outflow end of the frame.

2. The delivery assembly according to claim 1, wherein at least one of the sensors is oriented distally.

3. The delivery assembly according to claim 2, wherein at least one sensor is attached to the distal end of the elongated positioning member.

4. The delivery assembly according to claim 1, wherein at least one of the sensors is oriented laterally.

5. The delivery assembly according to any one of claims 2 to 4, wherein the sensor is a force sensor.

6. The delivery assembly according to claim 1, wherein the at least one sensor comprises at least two sensors connected to the at least one elongated positioning member.

7. The delivery assembly according to claim 6, wherein at least two of the sensors are spaced apart from each other in the axial direction.

8. The delivery assembly according to claim 6 or 7, wherein at least two of the sensors are pressure sensors.

9. The delivery assembly according to claim 1, wherein at least one of the sensors comprises a flow sensor.

10. The delivery assembly according to claim 1, wherein the at least one sensor comprises a first pressure sensor, and the delivery assembly further comprises a second pressure sensor attached to another component of the delivery assembly.

11. The delivery assembly according to any one of claims 1 to 10, wherein the at least one elongated positioning member comprises a loop, the loop defining two side segments and a bottom curved segment.

12. The delivery assembly according to claim 11, wherein the loop is formed of a shape memory material and is configured to adopt a predetermined shape that expands when not tightened inside the outer delivery shaft.

13. It is a method, Steps include advancing a delivery assembly, which includes a delivery device that supports an artificial valve in a radially compressed configuration, onto a natural heart valve, The steps include extending at least one elongated positioning member of the delivery device distally through the outer delivery shaft of the delivery device until the distal end of at least one elongated positioning member of the delivery device interacts with the proximal contact surface of the natural heart valve, The steps include acquiring a measurement signal from at least one sensor attached to the at least one elongated positioning member, A method comprising the step of expanding the artificial valve within the annular portion of the natural heart valve while the distal end of the at least one elongated positioning member is radially separated from the artificial valve.

14. The method according to claim 13, wherein the step of expanding the artificial valve within the annular portion includes the step of advancing the artificial valve from the outer delivery shaft into the annular portion.

15. The method according to claim 14, wherein the step of expanding the artificial valve within the annular portion includes the steps of partially expanding the artificial valve to a diameter smaller than the diameter of the annular portion, pausing the valve expansion, and fully expanding the artificial valve relative to the natural annular portion, and the method further includes the step of retracting the at least one elongated positioning member from the natural heart valve after partially expanding the artificial valve and before fully expanding the artificial valve.

16. The method according to claim 14 or 15, wherein the step of extending the at least one elongated positioning member includes the step of identifying the position of the proximal contact surface of the natural heart valve by monitoring the at least one elongated positioning member under X-ray fluoroscopy.

17. The method according to claim 16, wherein the step of advancing the artificial valve includes the step of positioning the inlet end of the artificial valve in an axial position with respect to the at least one elongated positioning member, while monitoring both the frame of the artificial valve and the at least one elongated positioning member under X-ray fluoroscopy.

18. The method according to any one of claims 13 to 17, wherein the at least one sensor is a distally oriented force sensor configured to contact the proximal contact surface.

19. The method according to claim 18, wherein the step of acquiring the measurement signal is performed in the extension of the at least one elongated positioning member passing through the outer delivery shaft, and the interaction between the at least one elongated positioning member and the proximal contact surface is identified by a force measured by the force sensor indicating contact with the proximal contact surface.

20. The method according to any one of claims 13 to 17, wherein the at least one sensor is a laterally oriented force sensor positioned between the artificial valve and the inner wall of the molar root during expansion of the artificial valve within the annular portion.

21. The method according to claim 20, wherein the step of acquiring the measurement signal is performed during the expansion of the artificial valve, and the measurement signal indicates the force exerted on the annular portion by the artificial valve.

22. The method according to any one of claims 13 to 21, wherein the at least one elongated positioning member is radiopaque, and the step of stretching the at least one elongated positioning member includes the step of identifying deformation of the elongated positioning member due to contact with the proximal contact surface, based on image guidance.

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