System and method for estimating the outer diameter of an artificial valve

Abstract

The present invention relates to systems and methods for estimating the expanded diameter of a prosthetic valve, and in particular to systems and methods for analyzing images acquired during expansion of the prosthetic valve, identifying and determining the dimensions of structural components of the valve, and estimating at least one outer diameter of the prosthetic valve, and potentially multiple outer diameters along different axial positions of the prosthetic valve.

Description

Technical Field

[0001] The present invention relates to a system and method for estimating the expanded diameter of an artificial valve, and more particularly to analyzing an image acquired during expansion of an artificial valve, identifying structural components of the valve, determining their dimensions, and estimating at least one outer diameter of the artificial valve, and potentially a plurality of outer diameters along different axial positions of the artificial valve.

Background Art

[0002] Natural heart valves, such as aortic valves, pulmonary valves, and mitral valves, function to ensure proper cardiac function and appropriate directional flow between the atria and ventricles in order to supply blood throughout the cardiovascular system. Various valvular heart diseases can render the valve dysfunctional and may require replacement with an artificial valve. Surgery can be performed to repair or replace the heart valve. Surgery is prone to a number of clinical complications, and thus alternative minimally invasive techniques of delivering an artificial heart valve on a catheter and implanting it over a natural dysfunctional valve have been developed over the years.

[0003] Mechanically expandable valves are a category of artificial valves that rely on a mechanical actuation mechanism for expansion. The actuation mechanism typically comprises a plurality of actuation / locking assemblies removably coupled to respective actuating members of the valve delivery system and controlled by an operation to actuate the assembly to expand the valve to a desired diameter. The assembly can, if necessary, lock the position of the valve to prevent the valve from being unnecessarily recompressed and the actuating member of the delivery system from being disengaged from the actuation / locking assembly of the valve, so that the valve can recover when properly positioned at the desired implantation site.

[0004] To mitigate the risk of annular rupture that may result from excessive expansion, and to avoid paravalvular leakage or other undesirable hemodynamic phenomena of the entire valve that may be associated with a mismatch between the expanded valve diameter and the surrounding tissue, it is desirable to expand the valve to the maximum size permissible by the patient's anatomical considerations when implanting an artificial valve, such as a mechanically expandable valve. To ensure the optimal implantation size, the diameter of the artificial valve should be monitored in real time during the implantation procedure. [Overview of the project] [Means for solving the problem]

[0005] This disclosure relates to an apparatus, assembly, and method for estimating the outer diameter of at least one prosthetic valve during prosthetic valve implantation and expansion procedures. Providing real-time estimation of the prosthetic valve diameter during valve expansion ensures that the prosthetic valve is properly implanted into a designated implantation site, such as the site of a malfunctioning native valve.

[0006] According to one aspect of the present invention, a method is provided for estimating the outer diameter of at least one artificial valve, comprising the step of acquiring an image of the artificial valve using an imaging device. The method further comprises the step of analyzing the image using a control circuit to determine at least one lateral width. The method further comprises the step of acquiring the length of a structural component of a certain length using a control circuit and relating the length to an identified structural component of a certain length.

[0007] The method further includes the step of estimating the outer diameter of at least one artificial valve based at least partially on the length of a structural component of a certain length, and the axial position of the estimated outer diameter, at least one lateral width determined by the axial position of the estimated outer diameter.

[0008] According to some embodiments, the step of analyzing an image to determine at least one lateral width further includes identifying structural components of the artificial valve before determining at least one lateral width.

[0009] According to some embodiments, the step of identifying structural components includes identifying the support segments of the artificial valve.

[0010] According to some embodiments, the step of identifying structural components includes identifying the joints of the artificial valve.

[0011] According to some embodiments, the step of identifying structural components includes identifying at least one cell, wherein at least one lateral width extends between two laterally aligned joints of the same cell.

[0012] According to some embodiments, at least one identified cell comprises at least two cells, and the plurality of lateral widths comprises at least one lateral width extending between the lateral junctions of each of the two cell columns.

[0013] According to some embodiments, the step of analyzing an image to determine at least one lateral width further includes determining at least one opening angle defined between two intersecting column segments, the opening angle facing the lateral width, and the lateral width being calculated from the opening angle and the length of the column segments.

[0014] According to some embodiments, the step of analyzing an image to determine at least one lateral width further includes determining at least one opening angle defined between the column segment and the lateral width, the lateral width being calculated from the opening angle and the length of the column segment.

[0015] According to some embodiments, the artificial valve comprises a plurality of threaded rods and a plurality of nuts, each nut being screwed onto its respective threaded rod, and the step of identifying the structural components includes identifying a plurality of nuts of the artificial valve, wherein at least one lateral width extends between each pair of identified nuts of the artificial valve.

[0016] According to some embodiments, at least one lateral width includes multiple lateral widths, each positioned at a different axial location along the length of the artificial valve.

[0017] According to some embodiments, the method further includes the step of analyzing an image using a control circuit to determine at least one vertical height, wherein the at least one vertical height includes a plurality of vertical heights, and the method further includes the step of comparing the vertical heights to generate data indicating whether the expansion of the artificial valve is non-uniform.

[0018] According to some embodiments, a structural component of a certain length is an outer member of an expansion and locking assembly that connects to the frame of the artificial valve.

[0019] According to some embodiments, a structural component of a certain length is a support segment of the artificial valve.

[0020] According to some embodiments, the step of estimating at least one outer diameter includes calculating the diameter of the circumscribed circle surrounding an inner polygon defined between joints positioned around the artificial valve in a corresponding transverse plane, where the length of each edge of the inner polygon is the transverse width determined at the axial position in the transverse plane, and the calculation further includes a conversion of distance from pixels to length units, at least in part on the length of a structural component of a certain length.

[0021] According to some embodiments, the step of estimating at least one outer diameter includes estimating at least two outer diameters based on lateral widths determined at different axial positions.

[0022] According to another aspect of the present invention, there is provided a computing system comprising a control circuit and a memory storing executable instructions that, when executed by the control circuit, cause the control circuit to perform a process including receiving an image of an artificial valve acquired by an imaging device. The process further includes analyzing the image to determine at least one lateral width. The process further includes analyzing the image to identify structural components of a fixed length.

[0023] The process further includes obtaining the length of the structural component of a fixed length and associating the length with the identified structural component of a fixed length. The process further includes estimating at least one outer diameter of the artificial valve based at least in part on at least one lateral width determined at an axial position of the estimated outer diameter and the length of the structural component of a fixed length. The process further includes outputting a display of the estimated at least one outer diameter.

[0024] According to some embodiments, analyzing the image to determine at least one lateral width further includes identifying structural components of the artificial valve before determining the at least one lateral width.

[0025] According to some embodiments, identifying the structural components includes identifying at least one cell, and the at least one lateral width extends between joints that align horizontally in two directions of the same cell.

[0026] According to some embodiments, the at least one lateral width includes a plurality of lateral widths, each positioned at a different axial position along the length of the artificial valve.

[0027] According to some embodiments, identifying the structural components further includes classifying the identified cells as closed cells or open cells.

[0028] According to some embodiments, at least one lateral width extends between two laterally aligned junctions of the same cell.

[0029] According to some embodiments, identifying a structural component includes identifying at least one cell column.

[0030] According to some embodiments, identifying a structural component further includes classifying a specified cell column as a vertex cell column or a non-vertex cell column.

[0031] According to some embodiments, at least one lateral width includes a plurality of lateral widths, each positioned at a different axial position along the length of the artificial valve.

[0032] According to some embodiments, at least two of the plurality of lateral widths extend between laterally aligned junctions associated with the same cell column.

[0033] According to some embodiments, at least one identified cell column includes at least two cells, and the plurality of lateral widths includes at least one lateral width that extends between the laterally aligned junctions of each of the two cell columns.

[0034] According to some embodiments, analyzing an image to determine at least one lateral width further includes determining at least one opening angle, and the lateral width is calculated from the opening angle and the length of the strut segment.

[0035] According to some embodiments, the opening angle is defined between two intersecting strut segments and the opening angle faces the lateral width.

[0036] According to some embodiments, the opening angle is defined between a strut segment and the lateral width.

[0037] According to some embodiments, the process further includes analyzing the image and determining at least one vertical height.

[0038] According to some embodiments, at least one vertical height includes multiple vertical heights, and the process further includes comparing the vertical heights and generating data indicating whether the expansion of the artificial valve is non-uniform.

[0039] According to some embodiments, a structural component of a certain length is an outer member of an expansion and locking assembly that connects to the frame of the artificial valve.

[0040] According to some embodiments, a structural component of a certain length is a support segment of the artificial valve.

[0041] According to some embodiments, estimating at least one outer diameter involves calculating the diameter of the circumscribed circle surrounding an inner polygon defined between the joints positioned around the artificial valve in a corresponding transverse plane, where the length of each edge of the inner polygon is the transverse width determined at the axial position in the transverse plane, and the calculation further involves a conversion of distance from pixels to length units, at least in part on the length of a structural component of a certain length.

[0042] According to some embodiments, the calculation further includes adding the product of the thicknesses of the joints.

[0043] According to some embodiments, the process further includes the step of estimating at least one inner diameter by performing the same calculation without adding the product of the thicknesses of the joints.

[0044] According to some embodiments, estimating at least one outer diameter involves estimating at least two outer diameters based on lateral widths, each determined at a different axial position.

[0045] According to some embodiments, estimating at least one outer diameter further includes estimating at least one outer diameter at an axial position where the lateral width has not been determined.

[0046] According to some embodiments, the outer diameter at an axial position where the lateral width is not determined is extrapolated from at least two outer diameters estimated from the lateral width determined at one of the axial positions.

[0047] According to some embodiments, the outer diameter at an axial position where the lateral width is not determined is interpolated from at least two outer diameters estimated from the lateral widths determined at the axial positions on either side thereof.

[0048] According to some embodiments, at least one estimated outer diameter is selected from the inlet diameter, outlet diameter, and / or rout diameter.

[0049] Some embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims contained herein. Aspects and embodiments of the present invention are further described herein in the following specification and appended claims.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to whom this invention relates. In case of any conflict, the definitions included in this specification shall prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more," unless the context clearly indicates otherwise.

[0051] The following embodiments and aspects are described and illustrated in relation to systems, tools, and methods, but are for illustrative and illustrative purposes only and are not limiting. In various embodiments, one or more of the above-mentioned problems are mitigated or resolved, while other embodiments focus on other advantages or improvements.

[0052] Several embodiments of the present invention are described herein with reference to the accompanying drawings. The specification, together with the drawings, will make it clear to those skilled in the art how some embodiments may be put into practice. The drawings are for illustrative purposes only and no attempt is made to show structural details of the embodiments in more detail than necessary for a basic understanding of the invention. For express purposes only, some objects shown in the figures are not to exact scale. [Brief explanation of the drawing]

[0053] [Figure 1] This is a perspective view of several embodiments of mechanically expandable artificial valves, each with and without soft components of the valve. [Figure 2] This is a perspective view of several embodiments of mechanically expandable artificial valves, each with and without soft components of the valve. [Figure 3A] Exploded perspective views, assembled perspective views, and side cross-sectional views of the extended and locking assemblies in several embodiments are shown, respectively. [Figure 3B] Exploded perspective views, assembled perspective views, and side cross-sectional views of the extended and locking assemblies in several embodiments are shown, respectively. [Figure 3C] Exploded perspective views, assembled perspective views, and side cross-sectional views of the extended and locking assemblies in several embodiments are shown, respectively. [Figure 4A] The following describes the steps taken by the actuation assembly to actuate the expansion and locking assembly in order to expand the artificial valve from a radially compressed configuration to a radially expanded configuration, according to several embodiments. [Figure 4B]The following describes the steps taken by the actuation assembly to actuate the expansion and locking assembly in order to expand the artificial valve from a radially compressed configuration to a radially expanded configuration, according to several embodiments. [Figure 4C] The following describes the steps taken by the actuation assembly to actuate the expansion and locking assembly in order to expand the artificial valve from a radially compressed configuration to a radially expanded configuration, according to several embodiments. [Figure 5A] This shows various stages of one embodiment of an expanded artificial valve, between a retracted configuration and a fully expanded configuration. [Figure 5B] This shows various stages of one embodiment of an expanded artificial valve, between a retracted configuration and a fully expanded configuration. [Figure 5C] This shows various stages of one embodiment of an expanded artificial valve, between a retracted configuration and a fully expanded configuration. [Figure 6] Several embodiments illustrate examples of configurations for estimating the valve diameter in real time during valve expansion procedures. [Figure 7A] The structural components and dimensions of the artificial valve, which can be identified and determined from acquired images, are shown in several embodiments. [Figure 7B] The structural components and dimensions of the artificial valve, which can be identified and determined from acquired images, are shown in several embodiments. [Figure 7C] The structural components and dimensions of the artificial valve, which can be identified and determined from acquired images, are shown in several embodiments. [Figure 8] The images show lateral cross-sections of artificial valves across a selected lateral plane between the inlet and outlet ends, according to several embodiments. [Figure 9A] The structural components and dimensions of other types of artificial valves, which can be identified and determined from acquired images, are shown by several embodiments. [Figure 9B] The structural components and dimensions of other types of artificial valves, which can be identified and determined from acquired images, are shown by several embodiments. [Figure 9C] The schematic diagrams of the polygons of the artificial valve across the entire lateral plane are shown in several embodiments. [Modes for carrying out the invention]

[0054] The following description explains various aspects of the disclosure. For explanatory purposes, certain structures and details are described in order to fully understand the various aspects of the disclosure. However, it will also be apparent to those skilled in the art that the disclosure can be implemented without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

[0055] Throughout the drawings, different embodiments of the same element are indicated using different superscripts for the same reference numeral. Embodiments of the disclosed apparatus and system may include any combination of different embodiments of the same element. Specifically, a reference to an element without a superscript may refer to any other embodiment of the same element indicated by a superscript. To avoid excessive confusion due to too many reference numerals and leader lines on a particular drawing, some components are introduced using one or more drawings and are not explicitly identified in all subsequent drawings containing that component.

[0056] Figures 1 and 2 show perspective views of exemplary embodiments of the prosthetic valve 100, with and without soft components (e.g., skirt and leaflet assembly), respectively. As used herein, “prosthetic valve” refers to any type of prosthetic valve deliverable to a patient’s target site on a catheter, which is radially expandable and compressible between a radially compressed or contracted state and a radially expanded state. Thus, the prosthetic valve 100 can be compressed or held in a compressed state by a delivery device (not shown) during delivery, and then expanded to an expanded state once the prosthetic valve 100 reaches the implantation site. The expanded state may include a range of diameters to which the valve can expand between the compressed state and the maximum diameter achieved in the fully expanded state. Thus, multiple partially expanded states may relate to any expansion diameter between the radially compressed or contracted state and the fully expanded state. The prosthetic valve 100 of this disclosure may include any prosthetic valve configured to be implanted in a natural aortic valve, natural mitral valve, natural pulmonary valve, and natural tricuspid valve.

[0057] As used in this specification, the term "multiple" means two or more.

[0058] According to some embodiments, the artificial valve 100 is a mechanically expandable valve. A mechanically expandable valve is a category of artificial valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism typically comprises a plurality of expansion and locking assemblies, which are detachably coupled to each actuation assembly of the delivery device and controlled via handles that actuate the expansion and locking assemblies to expand the artificial valve to a desired diameter.

[0059] The artificial valve 100 may have an inlet end 104 and an outlet end 102. In some cases, the outlet end 102 is the distal end of the artificial valve 100, and the inlet end 104 is the proximal end of the artificial valve 100. Alternatively, for example, depending on the valve delivery method, the outlet end may be the proximal end of the artificial valve, and the inlet end may be the distal end of the artificial valve.

[0060] As used herein, the term “proximal” generally refers to a location, direction, or part of any device or component of a device that is closer to the user and further away from the implantation site.

[0061] As used herein, the term “distal” generally refers to a location, direction, or part of any device or component of a device that is further from the user and closer to the implantation site.

[0062] As used herein, the term "outflow" refers to the area of ​​the artificial valve from which blood flows out through valve 100.

[0063] As used herein, the term "inflow" refers to the region of the artificial valve into which blood flows into valve 100.

[0064] The valve 100 comprises an annular frame 106 movable between a radially compressed structure and a radially expanded structure, and a valve leaflet assembly 124 mounted within the frame 106. The frame 106 can be made of a variety of suitable materials, including, but not limited to, plastically deformable materials, stainless steel, nickel-based alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys, e.g., MP35N alloy), polymers, or combinations thereof. According to some embodiments, the struts 110 are arranged in a grid pattern. In embodiments illustrated in Figures 1 and 2, the struts 110 are positioned obliquely or at an angle to the central axis of the valve 100, and radially offset from the central axis, when the valve 100 is in the expanded state. It will be apparent that the struts 110 can be offset at angles other than those shown in Figures 1 and 2, for example, oriented substantially parallel to the longitudinal axis of the valve 100.

[0065] According to some embodiments, the support columns 110 are pivotably connected to one another at a joint 114. In the exemplary embodiments shown in Figures 1 and 2, the ends of the support columns 110 form a vertex 116 at the outflow end 102 and a vertex 118 at the inflow end 104. The support columns 110 can be connected to one another at a separate non-vertex joint 120 formed between the outflow vertex 116 and the inflow vertex 118. The outflow vertex 116, the inflow vertex 118, and the non-vertex joint 120 constitute a particular type of joint 114.

[0066] Each support column 110 may have a support segment 112 defined between a series of joints 114. The joints 114 are equally spaced apart from each other along the length of each support column 110, thereby defining a plurality of support segments 112 having equal lengths. The frame 106 may have openings or vents 134 in the area of ​​the joints 114. Each hinge may be provided at a position where the openings 134 of the support columns 110 overlap each other, using fasteners, such as rivets or pins 136, that extend through the openings. The hinges or pins 136 may allow the support columns 110 to pivot relative to each other when the frame 106 is expanded or compressed radially.

[0067] In another embodiment, the support columns are not connected to one another via hinges, but are rotatable or bendable relative to one another to allow for expansion or compression of the frame. For example, the frame can be formed from a single piece of material, such as a metal tube, using various processes, such as but not limited to laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to fold / expand radially in the absence of hinges, etc.

[0068] The frame 106 further comprises a plurality of cells 108 defined between the intersections of the struts 110. The shape of each cell 108, and the angles between the intersections of the struts 110 defining the cell boundaries, change during expansion or compression of the artificial valve 100. An embodiment of diamond-shaped cells 108 defined between strut segments 112a, 112b, 112c, and 112d is shown in Figure 1. Further details relating to the structure of the frame and the artificial valve are described in U.S. Patent Applications Publications 2018 / 0153689, 2018 / 0344456, and 2019 / 0060057, all of which are incorporated herein by reference in their entirety.

[0069] As shown in Figure 2, the valve 100 may comprise a plurality of cell rows 130 formed around the frame 106. The cell rows 130 may alternately comprise rows 130a containing non-vertex rows, for example, cells 108a and 108b defined between non-vertex junctions 120a and 120c, and rows 130b containing vertex rows, for example, cells 108c, 108d, and 108e defined between vertices 116 and 118. Thus, each non-vertex cell row 130 can be sandwiched between two adjacent vertex cell rows 130, and each vertex cell row 130 can be sandwiched between two adjacent non-vertex cell rows 130.

[0070] Cell column 130 may comprise closed cells 108 and open cells 109. A closed cell 108 is defined by four pillar segments, for example, segments 112a, 112b, 112c, and 112d shown in Figure 1, while an open cell 109 is enclosed only by two pillar segments 112, for example, between two vertex junctions and one non-vertex junction. An embodiment of column 130b in Figure 2 includes three closed cells 108c, 108d, and 108e. An embodiment of column 130a includes two closed cells 108a and 108b, as well as two open cells 109a and 109b. In the exemplary embodiment, open cell 109a is defined above cell 108a between two outgoing vertices 116 and the nearest non-vertex junction 120a located between them. In the exemplary embodiment, the open cell 109b is defined below cell 108a between two inflow vertices 118 and the most distal non-vertex junction 120c located between them.

[0071] The leaflet assembly 124 comprises a plurality of leaflets 126 (e.g., three leaflets) and is at least partially positioned within the frame 106 and configured to control the flow of blood through the prosthetic valve 100 from the inlet end 104 to the outlet end 102. While three leaflets 126 arranged to collapse in a tricuspid configuration similar to that of a natural aortic valve are shown in the exemplary embodiment in Figure 1A, it will be apparent that the prosthetic valve 100 may comprise any other number of leaflets 126, for example, two leaflets configured to collapse in a bicuspid configuration similar to that of a natural mitral valve, or four or more leaflets, depending on the specific application. The leaflets 126 are made from a flexible material derived from a biological material (e.g., bovine pericardium or pericardium from other sources), a biocompatible synthetic material, or other suitable materials known in the Art and incorporated herein by reference, for example, U.S. Patents 6,730,118, 6,767,362 and 6,908,481.

[0072] Further details regarding the prosthetic valve, including how the valve leaflets 126 can be connected to the frame 106 either directly via the commissure 128, or via the commissure 128 attached to the frame 106 or to other structural elements embedded therein, such as the commissure 128 attached to the commissure post, or how the valve leaflets can be attached to the frame of the prosthetic valve, are described in U.S. Patents Nos. 7,393,360, 7,510,575, 7,993,394, and 8,252,202, and U.S. Patent Application No. 62 / 614,299, all of which are incorporated herein by reference.

[0073] According to some embodiments, the artificial valve may further comprise at least one skirt or sealing member. An inner skirt 122 may be mounted on the inner surface of the frame 106 and configured to function, for example, as a sealing member to prevent or reduce perivalve backflow. The inner skirt 122 may further function as a fixation area for the valve leaflets 126 to the frame 106 and / or may function to protect the valve leaflets 126 from damage that may be caused by contact with the frame 106, for example, while the valve is compressed or during the operating cycle of the artificial valve 100. Additionally or alternatively, the artificial valve 100 may comprise an outer skirt (not shown) mounted on the outer surface of the frame 106 and configured to function, for example, as a sealing member held between the frame 106 and the surrounding tissue of the natural valve annulus to which the artificial valve is mounted, thereby reducing the risk of perivalve leakage passing through the artificial valve 100. The inner skirt 122 and / or the outer skirt can be made from a variety of suitable biocompatible materials, for example, a variety of synthetic materials (e.g., PET) or natural tissues (e.g., pericardial tissue), but are not limited to these.

[0074] According to some embodiments, the artificial valve 100 comprises a plurality of expansion and locking assemblies 138 configured to facilitate the expansion of the valve 100 and, optionally, to lock the valve 100 in an expanded state to prevent unintended recompression. Figures 1-2 show three expansion and locking assemblies 138 mounted on a frame 106 and arranged equally spaced apart from each other around its inner surface as needed, but it will be apparent that different numbers of expansion and locking assemblies 138 can be used, that the expansion and locking assemblies 138 can be mounted on the frame around their outer surfaces, and that the circumferential spacing between the expansion and locking assemblies 138 may be uneven.

[0075] The artificial valve 100 can be delivered to the implantation site via a delivery assembly (not shown) that carries the radially compressed or retracted valve 100 toward the target site so that it can be attached to the natural anatomical structure by expanding the valve 100 via a mechanical expansion mechanism, as will be described in detail below. The delivery assembly may comprise a delivery device comprising a handle and a plurality of actuation assemblies 170 extending from the handle through a delivery shaft (not shown). Figure 2 shows three actuation assemblies 170 connected to three expansion and locking assemblies 138. The actuation assembly 170 may generally comprise actuators 172 (e.g., as seen in Figures 3A-4C) that are detachably connected at their distal ends to each expansion and locking assembly 138 of the valve 100, and sleeves 176 arranged around each actuator 172. Each actuator 172 may be axially movable relative to the sleeve 176 that covers it.

[0076] Figures 3A, 3B, and 3C show exploded perspective views, assembled perspective views, and cross-sectional side views, respectively, of expansion and locking assemblies 138 according to several embodiments. The expansion and locking assembly 138 may comprise a component of the valve 100, for example, an outer member 140 defining the lumen 142 of an outer member fixed to the frame 106 in a first position, and a component 114 of the 100, for example, an inner member 154 fixed to the frame 106 in a second position axially spaced from the first position.

[0077] The inner member 154 extends between its proximal end 156 and its distal end 158. The inner member 154 includes an inner member connecting extension 162 extending from its distal end 158, the extension 162 may be formed as a pin extending radially outward from the distal end 158 and configured to be received in each of the openings or openings 134 of the support columns 110 that intersect at the joint 114. The inner member 154 may further include a linear rack having a plurality of ratchet teeth 164 along at least a portion of its length. According to some embodiments, the inner member 154 further includes a plurality of ratchet teeth 164 along a portion of its outer surface.

[0078] The outer member 140 comprises a proximal end 144 that defines the proximal opening of the lumen 142 and a distal end 146 that defines the distal opening of the lumen 142. The outer member 140 comprises an outer member connecting extension 148 that extends from the proximal end 144, the extension 148 can be formed as a pin that extends radially outward from the outer surface of the proximal end 144 and is configured to be received in the respective openings 134 of the support columns 110 that intersect at the joint 114.

[0079] The outer member 140 may further comprise a spring-biased arm 150 that is attached to one side wall of the outer member 140 or extends therefrom, and has teeth or a stopper 152 at the opposite end, and is biased inward toward the inner member 154 when positioned within the lumen 142 of the outer member.

[0080] At least one of the inner member 154 or the outer member 140 is axially movable relative to the corresponding member. The extension and locking assembly 138 of the exemplary embodiment comprises a ratchet mechanism or ratchet assembly, wherein a chock 152 is configured to engage with the teeth 164 of the inner member 154. The spring-biased arm 150 may comprise an elongated body terminating with a chock 152 in the form of a locking tooth, configured to engage with the ratchet teeth 164 of the inner member 154. The chock 152 may have a shape complementary to the shape of the teeth 164, so that the chock 152 allows the inner member 154 to slide in one direction (e.g., proximal) relative to the spring-biased arm 150, and resists sliding of the inner member 154 in the opposite direction (e.g., distal) when the chock 152 engages with one of the teeth 164.

[0081] The arm 150 can be biased inward so that the stopper 152 is elastically held in a position where it engages with one of the teeth 164 of the inner member 154. In the exemplary embodiment, the spring-biased arm 150 is configured as a leaf spring. In some embodiments, the spring-biased arm 150 can be formed integrally with the outer member 140, and in other embodiments, the spring-biased arm 150 may be formed separately and then connected to the outer member 140. The biased structure of the arm 150 ensures that, under normal operation, the stopper 152 remains reliably engaged with the teeth 164 of the inner member 154.

[0082] The spring biasing arm 150 can be formed from a flexible or elastic portion of the outer member 140, extending over opposing sides of the outer surface of the inner member 154 and contacting it via its latch 152. According to some embodiments, the spring biasing arm 150 can be in the form of a leaf spring, formed integrally with the outer member 140 or formed separately and then connected to the outer member 140. The spring biasing arm 150 is configured to apply a biasing force to the outer surface of the inner member 154 so that, under normal operation, the latch 152 remains securely engaged with the ratchet teeth 164 of the inner member 154.

[0083] The mechanically expandable artificial valve 100 is removablely mountable to at least one, preferably multiple, actuation assemblies 170, corresponding to the number of expansion and locking assemblies 138. In some embodiments, the artificial valve 100 comprises three expansion and locking assemblies 138, and the delivery device comprises three actuation assemblies 170. The actuators 172 and sleeves 176 can be telescopically movable longitudinally relative to each other to expand and contract the frame 106 radially, as further described in U.S. Publications 2018 / 0153689, 2018 / 0153689, and 2018 / 0325665, which are incorporated herein by reference. The actuator 172 may be, for example, a wire, cable, rod, or tube. The sleeves 176 may be, for example, a tube or sheath with sufficient rigidity that can apply distal forces to the frame 106 or outer member 140 without bending or buckling.

[0084] The inner member further comprises a threaded bore 160, the proximal end 156 of the inner member configured to receive and screw into the threaded portion of the distal end 174 (for example, shown in Figure 4C) of the corresponding actuator 172. Figure 2 shows a perspective view of the valve 100 in the expanded state, having an expansion and locking assembly 138 connected to the actuator 172 (hidden and not visible within the sleeve 176). When the actuator 172 is screwed into the inner member 154, the axial movement of the actuator 172 causes the inner member 154 to move axially in the same direction.

[0085] According to some embodiments, the actuation assembly 170 is removably connected to the artificial valve 100 and configured to move the artificial valve 100 between a radially compressed structure and a radially expanded structure. Figures 4A-4C show an unrestrained structure illustrating the operation of the expansion and locking assembly 138 via the actuation assembly 170 for expanding the artificial valve 100 from a radially compressed structure to a radially expanded structure.

[0086] Figure 4A shows an extension and locking assembly 138 having an outer member 140 fixed to the frame 106 in a first position and an inner member 154 fixed to the frame 106 in a second position. According to some embodiments, the first position can be located at or adjacent to the outflow end 102, and the second position can be located at or adjacent to the inflow end 104. In the exemplary embodiment, the outer member 140 is fixed via an outer member connecting extension 148 to the nearest non-apex joint 120a distal to the outflow apex 116 or outflow end 102, and the inner member 154 is fixed via an inner member connecting extension 162 to the most distal non-apex joint 120c proximal to the inflow apex 118 or inflow end 104. The proximal portion of the inner member 154 extends into the lumen 142 of the outer member through the distal opening of the distal end 146 of the outer member.

[0087] Naturally, the exemplary embodiment relates to an expansion and locking assembly 138 fixed to the nearest non-vertex joint 120a, which functions as a first position, and to the farthest non-vertex joint 120c, which functions as a second position. In other embodiments, the expansion and locking assembly 138 can be fixed to other joints. For example, the expansion and locking assembly can be fixed to the outflow vertex 116 via an outer member connecting extension 148, which functions as a first position, and to the opposite inflow vertex 118 along the same cell row 130 via an inner member connecting extension 162, which functions as a second position.

[0088] Figure 4A shows the expanded and locked assembly 138 with the valve 100 in a radially compressed state, where the outlet apex 116 and inlet apex 118 are relatively separated from each other along the axial direction, and the proximal end 156 of the inner member is located distal to the proximal end 144 of the outer member.

[0089] As further shown in Figure 4A, the distal end 174 of the actuator is screwed into the threaded bore 160 of the inner member. According to some embodiments, as shown in Figures 4A-4C, the distal end 174 of the actuator has a male thread configured to engage with the female thread of the threaded bore 160 of the inner member. According to an alternative embodiment, the inner member may have a proximal extension with a male thread configured to be received and engage with the female thread of the distal bore formed within the actuator (example not shown).

[0090] The sleeve 176 may surround the actuator 172 and be connected to the handle of the delivery device. The sleeve 176 and the outer member 140 are sized so that the distal lip 178 of the sleeve 176 abuts against or engages with the proximal end 144 of the outer member, so as to prevent the outer member 140 from moving proximal beyond the sleeve 176.

[0091] To radially expand the frame 106 and therefore the valve 100, the sleeve 176 can be firmly pressed against the outer member 140. Next, as shown in Figure 4B, the actuator 172 can be retracted in the proximal direction 90. Since the sleeve 176 is pressed against the outer member 140 which connects to the frame 106 in the first position, it prevents the outflow end 102 of the frame 106 from moving relative to the sleeve 176. In this way, as the actuator 172 moves in the proximal direction 90, the inner member 154 moves in the same direction, thereby shortening the frame 106 axially and expanding it radially.

[0092] More specifically, as shown in Figure 4B, for example, the inner member connecting extension 162 extends through the opening 134 of the two support columns 110 which are interconnected at the distal non-apex joint 120c, while the outer member connecting extension 148 extends through the opening 134 of the two support columns 110 which are interconnected at the proximal non-apex joint 120a. In this way, when the inner member 154 is moved axially, for example in the proximal direction 90, within the outer member lumen 142, the inner member connecting extension 162 moves together with the inner member 154, thereby moving the portion to which the inner member connecting extension 162 is attached in the axial direction, and thereby shortening the frame 106 in the axial direction and expanding it in the radial direction.

[0093] When the frame 106 is expanded or compressed, the support columns 110 to which the inner member connecting extension 162 is connected pivot freely relative to the connecting extension 162 and to each other. In this way, the inner member connecting extension 162 functions as a fastener that forms a pivotable connection between the support columns 110. Similarly, when the frame 106 is expanded or compressed, the support columns 110 to which the outer member connecting extension 148 is connected also pivot freely relative to the connecting extension 148 and to each other. In this way, the outer member connecting extension 148 also functions as a fastener that forms a pivotable connection between the support columns 110.

[0094] As described above, when the stopper 152 of the spring biasing arm 150 engages with the ratchet teeth 164, the inner member 154 can move in one axial direction, for example, the proximal direction 90, but cannot move in the opposite axial direction. This ensures that while the stopper 152 is engaged with the ratchet teeth 164, the frame 106 can be reliably expanded radially but not compressed radially. Therefore, after the artificial valve 100 is implanted in the patient, the frame 106 can be expanded to the desired diameter by pulling the actuator 172. In this way, the operating mechanism also functions as a locking mechanism for the artificial valve 100.

[0095] Once the desired diameter of the artificial valve 100 is reached, the actuator 172 can be rotated, for example, in the rotational direction 92, as shown in Figure 4C, to detach the actuator 172 from the inner member 154. This rotation disengages the distal threaded portion 174 of the actuator 172 from the threaded bore 160 of the inner member, allowing the operating assembly 170, along with the delivery device, to be pulled back from the patient's body and remain implanted in the patient. In transcatheter aortic valve implantation, the patient's natural anatomical structures, such as the natural aortic annulus, may apply radial forces to the artificial valve 100 that attempt to compress it. However, the engagement between the chock 152 of the spring biasing arm 150 and the ratchet teeth 164 of the inner member 154 prevents such forces from compressing the frame 106, thereby ensuring that the frame 106 remains locked in the desired radially expanded state.

[0096] Therefore, the artificial valve 100 is radially expandable from the radially compressed state shown in Figure 4A to the radially expanded state shown in Figure 4B when the expansion and locking assembly 138 is actuated, and such actuation includes bringing the second position of the valve 100 closer to the first position. The artificial valve 100 is further releasable from the delivery device by separating each of the actuation assemblies 170 from each of the corresponding expansion and locking assemblies 138 attached thereto.

[0097] Although the frame 106 is shown to expand radially outward by axially moving the inner member 154 90 degrees proximal to the outer member 140, it will be understood that a similar expansion of the frame can be achieved by axially pushing the outer member 140 distal to the inner member 154.

[0098] In the above embodiments, a screw connection serving as an arbitrary reversible mounting mechanism between the actuation assembly 170 and the inner member 154 is illustrated and described. However, it should be understood that in other embodiments, other reversible mounting mechanisms may be utilized, and the inner member 154 may be configured to be attracted or pushed by the actuation assembly 170, while allowing for separation between them in any preferred manner so that the delivery device can be withdrawn from the patient's body at the end of the implantation procedure. For example, the distal end of the actuator may be provided with a magnet, and the inner member bore may be provided with a corresponding magnetic material to which the distal end of the actuator can extend.

[0099] While a specific operating mechanism utilizing a ratchet mechanism between the inner and outer members of the expansion and locking assembly 138 has been described above, other mechanisms, such as a screw mechanism or other engagement mechanism, may be used to facilitate the relative movement between the inner and outer members of the operating assembly. Further details relating to the structure and operation of a mechanically expandable valve and its delivery system are described in U.S. Patent No. 9,827,093, U.S. Patent Application Publications 2019 / 0060057, 2018 / 0153689 and 2018 / 0344456, and U.S. Patent Applications 62 / 870,372 and 62 / 776,348, all of which are incorporated herein by reference.

[0100] The artificial valve 100 can be delivered to the implantation site in a compressed state, and the frame 106 can be designed to have a cylindrical or substantially cylindrical structure while compressed, so as to have a substantially uniform diameter along the length of the artificial valve. In some configurations, the frame is configured to have a substantially cylindrical structure even during expansion, so that in the expanded state, the diameter of the frame 106 between the inlet end 104 and the outlet end 102 is substantially uniform.

[0101] In an alternative design, the frame may take on a frustoconical shape with a tapering structure during expansion and a varying diameter between the inlet end 104 and the outlet end 102 in various expanded structures, including various partially expanded structures.

[0102] Figures 5A–5C show various stages of an extended frame 106 embodiment between a retracted structure and a fully extended structure. The inlet end 104 has an inlet diameter Di, and the outlet end 102 has an outlet diameter Do. The frame 106 of the artificial valve 100 is shown across Figures 5A–5C, excluding the extension and locking assemblies for clarity of the diagram.

[0103] Figure 5A shows a shortened structure of the prosthetic valve 100, where the outflow diameter Do may be substantially equal to the inflow diameter Di. In some cases, the outflow diameter Do may be even narrower than the inflow diameter Do to facilitate the advancement of the prosthetic valve 100 through the patient's vascular system during delivery to the implantation site.

[0104] Figure 5B shows an intermediate, partially expanded structure of the artificial valve 100, where the valve 100 can take the shape of a frustoconical cone with an outflow diameter Do that is larger than the inflow diameter Di. Figure 5C shows a further expanded artificial valve, for example, a fully expanded structure, where the outflow diameter Do in this structure is larger than the outflow diameter Do in the partially expanded structure shown in Figure 5B, and the inflow diameter Di in this structure is larger than the inflow diameter Di in the partially expanded structure shown in Figure 5B.

[0105] In the fully extended structure shown in Figure 5C, the outflow diameter Do remains larger than the inflow diameter Di, however, the ratio of the outflow diameter to the inflow diameter Do / Di, or the absolute difference between both diameters Do and Di, may differ between the fully extended structure shown in Figure 5C and the partially extended structure shown in Figure 5B.

[0106] A potential advantage associated with the frustoconical shape of the frame 106, where the outlet diameter Do is larger than the inlet diameter Di, is that the wider outlet end 102 can provide an improved anchor for the artificial valve 100 at the location of the natural valve leaflets and / or valve ring, thereby providing improved hydrodynamic function. The smaller inlet diameter Di allows the frame 106 to be separated from the His bundle, reducing the risk of electrical conduction anomalies and rupture of the natural valve ring.

[0107] Referring here to Figure 6, an exemplary configuration 200 for real-time estimation of the valve diameter during a valve dilation procedure based on the analysis of one or more images acquired during valve dilation at the implantation site is illustrated. Configuration 200 includes one or more imaging devices 202 (referred to as “imaging devices 202” for ease of discussion) configured to acquire / generate one or more images of the prosthetic valve 100 during implantation in a patient 204, and one or more computing systems 206 (referred to as “computing systems 206” for ease of discussion) configured to analyze one or more images to estimate at least one diameter of the prosthetic valve 100. In some embodiments, a display of the estimated at least one diameter is output. As described below, the display of the estimated at least diameter may optionally include one or more estimated diameters in SI measurements and / or the axial shape of the prosthetic valve. The imaging devices 202 and computing systems 206 may be configured to transmit / receive data and / or other data, for example, including one or more images generated by the imaging devices 202, to communicate via wired or wireless communication equipment. The computing system 206 can be configured to receive input from a user, such as a physician, technician, or radiologist, and / or provide output to the user. In some embodiments, the imaging device 202 and the computing system 206 are located in the same facility / environment / location.

[0108] The imaging device 202 can be implemented as one or more X-ray devices, ultrasound devices, and / or other types of medical imaging devices. The imaging device 202 can generally be configured to capture / produce one or more images including visual representations of anatomical structures within the body, e.g., the patient's organs / tissues / other anatomical functional parts, and prosthetics placed in the patient's body, e.g., stents, prosthetic valves. According to some embodiments, the imaging device 202 is a fluoroscopy imaging device. As illustrated in the embodiment shown in Figure 6, the fluoroscopy device may comprise a fluoroscopy source and a fluoroscopy detector. In some embodiments, configuration 200 comprises a fluoroscopy device 202 and a monitor 216. The fluoroscopy source can be positioned above the patient 204 to obtain a 30-degree left anterior oblique (LAO) projection, for example, 30-40 degrees, with a 30-degree cranial tilt (for orthogonal projection of the aortic valve annulus). In some embodiments, the imaging device 202 includes a fluoroscopy device used in combination with multiple devices, such as an ultrasonic probe (not shown) for image improvement.

[0109] The computing system 206 can be implemented as one or more computing devices, such as one or more desktop computers, laptops, servers, smartphones, e-reader devices, mobile phones, personal digital assistants, portable navigation devices, portable game consoles, tablet computers, wearable devices (e.g., watches, optical head-mounted displays, etc.), portable media players, televisions, set-top boxes, in-car computer systems, electrical appliances, cameras, security systems, home computer systems, projectors, medical monitors, etc. In some embodiments, one or more computing devices consist of a cluster, a data center, a cloud computing environment, or a combination thereof. In some embodiments, one or more computing devices are implemented as local resources located locally in the environment of the imaging device 202.

[0110] As shown in the figures, the computing system 206 may comprise one or more of the following components, devices, modules, and / or units (hereinafter referred to as “Components”), for example, a control circuit 210, one or more network interfaces 212, one or more imaging components 214, one or more I / O interfaces 216, and / or memories 218, individually and / or in combination and collectively. While some components of the computing system 206 are illustrated in Figure 6, it should be understood that other components not shown may be included in embodiments of this disclosure. Furthermore, in some embodiments, some of the illustrated components may be omitted.

[0111] Although the control circuit 210 is illustrated as a separate component in Figure 6, it should be understood that any or all of the remaining components of the computing system 206 can be at least partially embodied in the control circuit 210. That is, the control circuit 210 may include various (active and / or passive) devices, semiconductor materials and / or regions, layers, areas and / or parts thereof, conductors, leads, vias, connectors and / or similar, and one or more and / or parts thereof of the other components of the computing system 206 can be at least partially formed and / or embodied by / by such circuit components / devices. Specifically, considering the process performed by the dimension-determining component 220, illustrated as a component of memory 218 in Figure 6 and shown separately from the control circuit 210, it may actually be performed by the control circuit 210, and either memory 218 and / or the dimension-determining component 220 can be implemented within the control circuit 210. Furthermore, in some embodiments, the dimension determination component 220 is embodied as a series of instructions (e.g., software commands and algorithms) executed by the processor of the control circuit 210.

[0112] Various components of the computing system 206 can be electrically and / or communicatively coupled using specific connecting circuits / devices / functions, which may or may not be part of the control circuits 210. For example, the connecting function may include one or more printed circuit boards configured to facilitate the mounting and / or interconnection of at least some of the various components / circuits of the computing system 206. In some embodiments, one or more control circuits 210, one or more network interfaces 212, one or more imaging components 214, one or more I / O interfaces 216, and / or databases / memories 218 can be electrically and / or communicatively coupled to one another.

[0113] One or more network interfaces 212 can be configured to communicate with one or more devices / systems over one or more networks. For example, one or more network interfaces 212 can send and receive data, such as one or more images captured by an imaging device 202, wirelessly and / or via wired connections over the network. The network can include various communication protocols, such as a local area network (LAN), a wide area network (WAN) (e.g., the Internet), a personal area network (PAN), a body area network (BAN), etc. In some embodiments, one or more network interfaces 212 can implement wireless technologies, such as Bluetooth, Wi-Fi, or near-field communication (NFC).

[0114] One or more imaging components 214 may include generators, sensors, detectors, cameras, etc., configured to provide / generate and / or receive / detect signals / radiation, and which can be used to acquire / generate one or more images. Although schematically shown as part of a computing system 206 that can communicate with the imaging device 202, it should be understood that one or more imaging components 214 may be located within the imaging device 202, and in some embodiments, the computing system 206 may be a control system for the imaging device 202 that is interconnected with other components of the imaging device 202.

[0115] One or more I / O components 216 may include various components for receiving inputs and / or providing outputs, for example, to interface with a user. One or more I / O components 216 may be configured to receive touch, speech, gestures, or any other type of input. Furthermore, one or more I / O components 216 may be configured to output display data, audio data, haptic feedback data, or any other type of output data. One or more I / O components 216 may include one or more displays (sometimes called "one or more display devices"), touchscreens, touchpads, controllers, mice, keyboards, wearable devices (e.g., optical head-mounted displays), virtual reality devices or augmented reality devices (e.g., head-mounted displays), speakers (e.g., configured to output sound based on audio signals), microphones (e.g., configured to receive sound and generate audio signals), cameras, etc. One or more displays may include one or more liquid crystal displays (LCDs), light-emitting diode (LED) displays, organic LED displays, plasma displays, e-paper displays, and / or any other type of technology. In some embodiments, one or more displays include one or more touchscreens configured to receive input and / or display data.

[0116] As illustrated, the memory 218 may include a dimensioning component 220, a graphical user interface component 222, and / or an image processing component 224 configured to facilitate various functions described herein. In some embodiments, one or more of the components 220-224 may, when executed by the control circuit 210, include one or more executable instructions causing the control circuit 210 to perform one or more steps, and / or may be implemented as one or more executable instructions. While many examples have been discussed relating to components 220-224 that include one or more instructions executable by the control circuit 210, any of the components 220-224 may be implemented, at least in part, as one or more hardware logic components, such as one or more application-specific integrated circuits (ASICs), one or more field-programmable gate arrays (FPGAs), one or more program-specific standard products (ASSPs), one or more complex complex-programmable logic devices (CPLDs), etc. Furthermore, although components 220-224 are exemplified as being contained within the computing system 206, any of components 220-224 can be at least partially implemented in another device / system, such as the imaging device 202 (e.g., a fluoroscopy device) and / or another device / system. Similarly, any other component of the computing system 206 can be at least partially implemented in another device / system.

[0117] The dimension determination component 220 can be configured to identify one or more dimensions of the artificial valve 100. The dimension determination component 220 can analyze one or more images acquired by the imaging device 202. By analyzing one or more acquired images, one or more dimensions of the artificial valve 100 can be determined. The dimensions of the artificial valve 100 may include the lengths of the components of the artificial valve 100, the features of the artificial valve 100 or the distance between components, the ratio of the lengths of the components of the artificial valve 100, and / or the angles between the components of the artificial valve 100. For example, the dimensions of the artificial valve 100 may include the distance between the joints 114 of the artificial valve 100 and / or the angles between the intersecting strut segments 112. The dimension determination component 220 can store data indicating such dimensions of the artificial valve 100 in the database 226.

[0118] In some embodiments, the dimensional determination component 220 can analyze one or more images acquired by the imaging device 202 (e.g., a fluoroscopy device) to identify structural components of the artificial valve 100 visible in the acquired images, such as radiopaque structural components of the artificial valve 100, such as the support column 110 and its support column segments 112, the joint 114, the pin 136 that can extend through the opening 134, and components of the expansion and locking assembly 138, such as the outer member 140.

[0119] In some embodiments, the dimensional determination component 220 can analyze one or more images acquired by the imaging device 202 (e.g., a fluoroscopy device) to further identify anatomical structures near the implanted prosthetic valve 100, such as the wall surrounding the natural valve annulus into which the prosthetic valve 100 is implanted. Such anatomical structures may include, for example, the wall of the ascending aorta 12, the aortic valve annulus 14, the valve leaflets 16, and / or the LVOT 18 (e.g., shown in Figure 7A).

[0120] In some embodiments, the dimensional determination component 220 can analyze multiple images from various orientations / positions / angles. For example, the dimensional determination component 220 can identify one or more dimensions and / or positions of structural components of the artificial valve 100 by analyzing a first image from a first orientation / position in the patient and a second image from a second orientation / position in the patient. In some embodiments, the positions of structural components of the artificial valve 100 may include the coordinates of one or more structural components in a coordinate system / space.

[0121] In some embodiments, the dimensions and / or positions of one or more structural components of the artificial valve 100 may include the dimensions / positions of the visual representations of the structural components of the artificial valve 100 and / or the dimensions of the artificial valve 100 in an image, such as the size / length / distance of the visual representation, the color / shading of the visual representation, the position of the visual representation in the image, etc.

[0122] In some embodiments, the dimension determination component 220 works in conjunction with a graphical user interface component 222. For example, the graphical user interface component 222 can be configured to provide an interface that includes an image. A user, such as a physician or technician, can view the image and make input regarding the dimensions of the artificial valve 100 or the location of structural components of the artificial valve 100. In one embodiment, the user can specify a representation in the image to represent a particular structural component, such as a support segment 112, an outer member 140, etc. In another embodiment, the user can specify a first point / location in the image and a second point / location in the image and make a request to calculate the distance between the first point / location and the second point / location. The user can also make input to label the distance. In the embodiment, the user can make input to determine / display any of the dimensions of the artificial valve 100. In the embodiment, the dimension determination component 220 can analyze one or more images using input provided by the user, and / or store data relating to one or more features / locations of one or more dimensions of the artificial valve 100 and / or the locations of structural components of the artificial valve 100 in the database 226.

[0123] Furthermore, in some embodiments, the dimension determination component 220 works in conjunction with the image processing component 224 to analyze images. For example, the image processing component 224 can perform one or more image processing techniques on one or more images to automatically identify image-based features in one or more images and / or classify the image-based features as structural components of the artificial valve 100. In some embodiments, the image processing component 224 analyzes one or more images using one or more intelligent techniques, such as one or more machine-trained models. In embodiments, the dimension determination component 220 can analyze one or more images using the information determined by the image processing component 224 and / or store data regarding one or more features / locations of one or more dimensions of the artificial valve 100 and / or the locations of structural components of the artificial valve 100 in the database 226.

[0124] The data / information generated / determined herein can be used in a variety of ways. In some embodiments, data relating to one or more dimensions of the artificial valve 100 can be used to obtain real-time estimates of the valve expansion diameter in various regions of the artificial valve 100, and this can be used to generate instructions / information such as whether the artificial valve 100 needs to be further expanded, whether the expansion procedure needs to be stopped, or whether the artificial valve 100 needs to be recompressed. In embodiments, such information can be presented to the user via a user interface.

[0125] As described above, the database 226 can store one or more images acquired by the imaging device 202, and can also store data on the dimensions of the artificial valve 100 and / or the location of the structural components of the artificial valve 100, as well as the estimated expansion diameter and any generated instructions / information. Although the database 226 is exemplified as being contained within the computing system 206, in some embodiments the database 226 may be implemented elsewhere, for example, in a remote resource.

[0126] The term “control circuit” is used herein in accordance with its broad and ordinary meaning and can refer to one or more processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including one or more active and / or passive devices and / or connection circuits), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, image processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any group of any devices that manipulate signals (analog and / or digital) based on hardcoding of circuits and / or operation instructions. A control circuit may further comprise one or more storage devices that can be embodied in a single memory device, multiple memory devices, and / or embedded circuits of a device. Such data storage may include read-only memory, random-access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. In embodiments in which the control circuit includes a hardware state machine (and / or an implementation of a software state machine), analog circuits, digital circuits, and / or logic circuits, it should be noted that data storage devices / registers for storing any associated operation instructions may be incorporated within or outside the circuit including the state machine, analog circuits, digital circuits, and / or logic circuits.

[0127] The term “memory” is used herein in accordance with its broad and ordinary meaning and can refer to any suitable or desirable type of computer-readable medium. For example, computer media can include one or more volatile data storage devices, non-volatile storage devices, removable data storage devices, and / or non-removable data storage devices implemented using any technology, layout, and / or data structure / protocol, which include any suitable or desirable computer-readable instructions, data structures, program modules, or other types of data.

[0128] Computer-readable media that can be implemented according to embodiments of this disclosure include, but are not limited to, phase-change memory, static random-access memory (SRAM), dynamic random-access memory (DRAM), other types of random-access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technologies, compact disc read-only memory (CD-ROM), digital versatile disc (DVD) or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other non-temporary media that can be used to store information for access by computing devices. In the specific context of this specification, computer-readable media typically do not include communication media, such as modulated data signals and carrier waves. Therefore, computer-readable media should generally be understood to refer to non-temporary media.

[0129] Figures 7A-7C illustrate an example of an artificial valve 100 (which can be expanded relative to the aortic valve annulus 14 as shown in Figure 7A), and show the structural components of the artificial valve 100 and the dimensions of the artificial valve 100, which can be identified and determined by the dimensional determination components 220, based on the analysis of images acquired by the imaging device 202 in the figures shown in Figures 7A-7C.

[0130] As used herein, the term "image" is used for simplicity to refer to either a single acquired image or two or more acquired images.

[0131] In some embodiments, the techniques and systems discussed herein can analyze images taken during the implantation procedure of the prosthetic valve 100, more precisely, during the expansion of the prosthetic valve 100 within the desired implantation site in the patient's body, in order to identify structural components of the prosthetic valve 100, such as the joint 114, support segments 112, cells 108, cell rows 130, the outer member 140 of the expansion and locking assembly 138, and potentially structural elements of the anatomical structures surrounding the prosthetic valve at the implantation site, such as the aortic wall 12, aortic annulus 14, leaflets 16, and LVOT 18. Based on the identification of the structural components of the prosthetic valve 100 visible / represented in the images, the techniques and systems can determine the dimensions of the prosthetic valve 100, analyze the expansion diameter of the valve based on such dimensions, and provide instructions / information accordingly.

[0132] Figure 7A shows some exemplary dimensions that can be determined from the acquired image, including the lateral distance W between the joints 114. In some embodiments, the process for estimating at least one expanded diameter of the artificial valve includes determining at least one, and optionally multiple, lateral distances W between the joints 114 along the non-vertex cell row 130, e.g., lateral distances W1, W2, W3, and W4 shown in Figure 7A.

[0133] The process may include the identification of structural components necessary to identify non-vertex rows, for example, non-vertex row 130d sandwiched between vertex cell rows 130c and 130e shown in Figure 7A. Identification of cell row 130 can be initiated by identifying support segments 112 and / or junctions 114 that may be contained within such cells. Once junctions 114 are identified in the acquired image, such junctions are identified as non-vertex junctions 120 or as vertex junctions, for example, outflow vertices 116 and / or inflow vertices 118.

[0134] In some embodiments, the identification of the type of joint 114 may be based solely on their position relative to each other, and the classification as vertex and non-vertex cell columns 130 may be based solely on the joint 114 contained in each column. In some embodiments, the process further includes the identification of strut segments 112 extending between the joints 114. A joint 114 can be identified by identifying either an opening 134, a pin 136, and / or an intersection between strut segments 112. In some embodiments, the positions of intersecting strut segments 112 can be used to classify the joints 114 as non-vertex joints 120, outflow vertices 116, and / or inflow vertices 118.

[0135] In some embodiments, the process further includes identifying closed cells 108 and open cells 109 based on identified intersecting strut segments 112 and / or junctions 114 of the cells, where a closed cell 108 comprises four junctions 114 and four intersecting strut segments 112, while an open cell 109 comprises three junctions 114 and two strut segments 112, where one of the three junctions is a non-vertex junction and the other two are outflow vertices 116 or inflow vertices 118.

[0136] The process may further include determining at least one lateral distance W along different axial positions of the non-vertex cell column 130d, for example, the lateral distance W1 between junctions 114(1,1) and 114(1,2), which are the outflow vertex 116; the lateral distance W2 between junctions 114(2,1) and 114(2,2); the lateral distance W3 between junctions 114(3,1) and 114(3,2); and the lateral distance W4 between junctions 114(4,1) and 114(4,2), which are the inflow vertex 118. The multiple lateral distances W1 to W4 are substantially parallel to each other, as shown.

[0137] The lateral distance W can be determined from the distance between two consecutive joints at the lateral ends on both sides of the closed cell 108, such as the lateral distances W2 and W3 shown in Figure 7, or from the distance between two consecutive vertices 116 and 118, such as the lateral distance W1 located at the outlet end 102 of the valve or the lateral distance W4 located at the inlet end 104 of the valve.

[0138] Dimensions, such as lateral distances W (e.g., W1-W4), may be measured in pixels. In some embodiments, at least one constant-length structural component of the artificial valve 100 is provided, which is defined as a structural component whose length does not change throughout the entire implantation procedure, and whose length is known and can serve as a metric unit used, for example, to calibrate other dimensions and convert pixels to SI units. In some embodiments, a component of the expansion and locking assembly 138, such as the outer member 140, can function as a constant-length structural component having a known constant outer member length Lp, as shown in Figure 7A. Other types of artificial valves may have another constant-length structural component, such as a commissar post that is attached to or integrally formed with the frame and has a vertical post length Lp. In some embodiments, a strut segment 112 can function as a constant-length structural component having a strut segment length Ls (see, for example, Figure 7C).

[0139] Components that can function as structural components of a fixed length are rigid components that do not deform, whose length does not shorten or change during valve expansion, and which are identifiable in acquired images as, for example, radiopaque (e.g., made of metallic material).

[0140] It should be understood that other components of the artificial valve that need to be identified in the acquired image, such as its strut 110 and segment 112, or pin 136, may also preferably be radiopaque, or otherwise should be identifiable by having an identifiable radiopaque boundary, for example, an identifiable opening 134 within the metal strut 110.

[0141] The estimation of the expanded diameter of the artificial valve 100 may be based on at least one lateral distance W. In some embodiments, a single lateral distance W is determined. This may be sufficient if the artificial valve 100 expands into a cylindrical structure having a uniform expanded diameter along its length. In such cases, the estimation of the expanded diameter at any axial position along the artificial valve 100 based on any lateral distance W may indicate the expanded diameter along any other axial position of the artificial valve.

[0142] In some embodiments, at least two lateral distances W are determined at different axial positions along the prosthetic valve 100. For prosthetic valves that expand into a non-cylindrical structure, such as the frustoconical structure described above in relation to Figures 5A-5C, multiple lateral distances W may be required to estimate the expansion diameter at different axial positions of the prosthetic valve 100. The lateral distance W measured between two joints 114 at each axial position along the prosthetic valve 100 can be used to estimate the expansion diameter at that axial position, and two lateral distances W at different axial positions can be used to estimate the expansion diameter along other axial positions of the prosthetic valve 100, for example, by mathematical interpolation or extrapolation. Three or more lateral inter-joint distances W may be determined to improve the accuracy of the extrapolation interpolation along other axial regions of the prosthetic valve 100.

[0143] As used herein, the term “axial direction” refers to the direction extending between the inlet end 104 and the outlet end 102 (also known as the valve height). References to different axial positions refer to different heights along the artificial valve 100 between the inlet end 104 and the outlet end 102.

[0144] The inlet end 104 can define an inlet plane passing through all inlet vertices 118, and similarly, the outlet end 102 can define an outlet plane passing through all outlet vertices 116. Multiple transverse planes can be defined between the inlet and outlet planes, parallel to each other and parallel to the inlet and outlet planes. Reference to transverse planes refers to planes between the inlet and outlet planes that are parallel to them.

[0145] Each lateral width W is defined along such a lateral plane, and the expanded diameter of the prosthetic valve at the same lateral plane height (or axial position) can be estimated from the lateral width W. Thus, the lateral width W1 can be used to estimate the expanded diameter in the outflow plane and is also called the outflow diameter Do. The lateral width W4 can be used to estimate the expanded diameter in the inflow plane and is also called the inflow diameter Di. The lateral width W2 can be used to estimate the expanded diameter at the height of the lateral plane passing through joints 114(2,1) and 114(2,2), and the lateral width W3 can be used to estimate the expanded diameter at the height of the lateral plane passing through joints 114(3,1) and 114(3,2).

[0146] In the case of an artificial valve expanded into a frustoconical shape with non-uniform diameters, the width in each lateral direction at different axial positions can be of different sizes. For example, as shown in Figure 7A, W4 <W3<W2<W1である。

[0147] Figure 7B shows another exemplary dimension that can be determined from the acquired image, including the vertical height H and lateral distance W between the joints 114. In some embodiments, the process for estimating at least one expanded diameter of the artificial valve includes determining at least one, and optionally multiple, lateral distances W and / or vertical heights H between the joints 114 along the vertex cell row 130, e.g., lateral distances W5, W6, W7 and vertical heights H1 and Hio shown in Figure 7B.

[0148] The process may include the identification of structural components necessary to identify vertex rows, for example, vertex cell row 130e sandwiched between non-vertex cell rows 130d and 130f shown in Figure 7B. The identification of the support segments 112 and cell rows 130, as well as the identification and classification of the joints 114, can be performed in the same manner as described above with respect to the identification of non-vertex rows.

[0149] The process may further include determining at least one lateral distance W along different axial positions of the vertex cell column 130e, for example, the lateral distance W5 between junctions 114(5,1) and 114(5,2), which are the nearest non-vertex junction 120a; the lateral distance W6 between junctions 114(6,1) and 114(6,2); and the lateral distance W7 between junctions 114(7,1) and 114(7,2), which are the farthest non-vertex junction 120c.

[0150] The multiple lateral distances W5 to W7 are substantially parallel to each other, as shown. The lateral width W5 can be used to estimate the expansion diameter in the lateral plane passing through joints 114(5,1) and 114(5,2). The lateral width W6 can be used to estimate the expansion diameter in the lateral plane passing through joints 114(6,1) and 114(6,2). The lateral width W7 can be used to estimate the expansion diameter in the lateral plane passing through joints 114(7,1) and 114(7,2). In the case of an artificial valve expanded into a frustoconical shape with non-uniform diameters, each lateral width at different axial positions can have different sizes. For example, as shown in Figure 7B, W7 <W6<W5である。

[0151] In some embodiments, the lateral width W can be determined along two or more cell rows 130. For example, at least some of the lateral widths W1 to W4 can be determined between joints 114 located at the lateral ends on both sides of the intersecting support segment 112 of a non-vertex cell row 130d, and at least some of the lateral widths W5 to W7 can be determined between joints 114 located at the lateral ends on both sides of the intersecting support segment 112 of a vertex cell row 130e. Since the lateral widths W1-W4 and W5-W7 are located in different axial positions, for example, W5 along a lateral plane located between the lateral planes of W1 and W2, W2 along a lateral plane located between the lateral planes of W5 and W6, and so on, by identifying the lateral widths from adjacent vertex cell rows and non-vertex cell rows, the resolution of the number of diameters estimated at different axial positions of the valve can be improved, thereby improving the accuracy of interpolation or extrapolation performed to estimate the extended diameter value at axial positions that do not cross a particular lateral joint 114 or the identified lateral width W.

[0152] According to some embodiments, the dimensions determined from the acquired image may include the vertical height between two joints 114 aligned along a vertical line. For example, Figure 7B shows an embodiment of the height H1 between two joints 114 of a cell, including the lateral width W7. Thus, the lateral width W7 and the vertical height H1 together can provide the width and height of the cell to which they extend.

[0153] H1 is an example of a vertical height H1 extending between opposing vertical junctions of a single cell 108, but other vertical heights H can be determined between opposing vertical junctions of multiple cells. For example, Hio shown in Figure 7B spans three cells aligned perpendicularly to each other, more specifically extending perpendicularly between the inlet vertex 118 and the outlet vertex 116, thereby representing the overall vertical height of the frame 106 between the inlet end 104 and the outlet end 102. Other heights span multiple cells but may be lower than the overall height of the frame.

[0154] In the case of a truncated cone-shaped artificial valve with non-uniform diameter, cells at different axial positions along the same cell row may have different vertical heights, as shown in Figure 7B, for example, where H1 is longer than the vertical height of the cells perpendicularly aligned with it at an axial position proximal to it.

[0155] In the embodiment of Figure 7B, it is shown that the vertical height is determined between the junctions of vertex rows, such as cell row 130e, but it should be understood that the vertical height can be similarly determined between the junctions of non-vertex rows, such as cell row 130d. In some embodiments, the determination of dimensions from the acquired image may include at least one lateral width, at least one vertical height, and / or a combination thereof. The vertical height can be determined to estimate the shortening of the frame during frame expansion. Using the shortening of the frame, the expanded diameter can be derived based on a known relationship between axial shortening and radial expansion, and thus may be useful as another method used to estimate the expanded diameter, which can be used in combination with a lateral width-based estimate to improve the accuracy of the estimated diameter.

[0156] In some embodiments, two or more vertical heights H, determined along two or more cell rows 130, thereby representing vertical heights H at different lateral positions around the entire circumference of the artificial valve, can indicate whether the valve expands uniformly or non-uniformly along its circumference and the degree of non-uniformity at different circumferential positions during its expansion.

[0157] Figure 7C shows another example of dimensions that can be determined from the acquired image, including the column opening angles α, β, γ and the lateral distance W between the joints 114, which can be derived from the acquired image. The opening angle may have a vertically oriented opening angle α defined at the intersection between the two column sections 112 and oriented perpendicularly from the intersection. For example, Figure 7C shows a vertically oriented opening angle α1 defined between column sections 112c and 112f that intersect at a joint 114 which can be identified by the opening 134(5).

[0158] Multiple angles, for example, α1, α2, and α3 aligned vertically along the same cell column 130, for example, cell column 130d shown in Figure 7C, can be determined. The vertical aperture angles α1, α2, and α3 can be oriented proximal, and the corresponding vertex angles β1, β2, and β3, which are vertical aperture angles oriented distal, can be determined in a similar manner.

[0159] The opening angle can similarly have a laterally oriented opening angle γ that is oriented laterally from the intersection. In some cases, the laterally oriented opening angle γ is defined at the intersection between two column segments 112. For example, γ2 and γ3 shown in Figure 7C are defined between intersecting column segments 112 and are in fact adjacent and complementary angles to α2 and α3 (or β1 and β2). Another type of laterally oriented opening angle γ can be defined between a column segment 112 and the lateral width W that intersects it. For example, γ1 may be defined between a column section 112f and the lateral width between openings 134(1 / 1) and 134(1,2), which is in fact W1 between the same joints shown in Figure 7A (not annotated again in Figure 7C to avoid confusion). Thus, either γ1 or γ4 shown in Figure 7C can be about half the size of the adjacent and complementary angles of α1 and β3, respectively.

[0160] The opening angle can be determined from the acquired image and used in combination with a known column section length Ls to derive a suitable lateral width W extending between the corresponding opposing lateral joints 114. For example, as shown in Figure 7C, if the joint 114 is identified by an opening 134, the column segment length Ls may be defined as the length between the openings 134 at both ends of the column segment 112. This length Ls may be slightly angled with respect to the edges of the column segment 112 if the openings 134 at both ends of the column segment are offset from each other, as shown.

[0161] Therefore, by determining α1 and using it in combination with a known length Ls, the lateral width W1 between the openings 134(1,1) and 134(2,1) can be derived. If the openings 134 or pins 136 are detectable in the acquired image and used to identify the spatial position of the openings 134, it should be understood that references to the dimensions determined for the joint 114 are similarly applicable to the same dimensions determined for the openings 134 or pins 136 at similar positions throughout the frame 106.

[0162] Determining the aperture angles, e.g., angles α, β, γ, can be advantageous because the angles can function as a dimensionless measure used to estimate various distances, e.g., lateral length W and / or vertical height H, and it is not necessary to measure such distances as quantities of pixels that are later calibrated to lengths in SI units. Nevertheless, in some embodiments, for example, to improve the accuracy of the evaluation process, both the direct determination of distances, e.g., lateral width W and / or vertical height H, and the determination of aperture angles, from which some of these distances can be derived, are performed.

[0163] Advantageously, the proposed method does not rely on pre-measured relationships between dimensions, such as the opening angle or distance and the valve's expansion diameter, and does not compare the dimensions determined from the acquired image with a table or graph that stores such relationships.

[0164] Figure 8 shows a lateral cross-section of the artificial valve 100 over the entire selected lateral plane between the inlet and outlet ends. As described above, the artificial valve 100 may comprise two layers of intersecting struts 110, comprising an inner strut 110i and an outer strut 110o, as shown. The joint 114 may be identified by an opening 134 extending through it (shown in the enlarged area of ​​Figure 8), or by a pin 136 extending through such an opening (the pin is not shown in Figure 8 for clarity). As further shown in Figure 8, each opening 134 may extend through a portion of the corresponding inner strut 110i, and the lateral width W described above is actually measured between the openings 134 extending through the inner strut 110i.

[0165] As further shown in Figure 8, multiple openings 134 defined along a single transverse plane across the circumference of the frame 106 can define an inner polygon Pi having multiple edges, each having a polygonal edge length Le. The estimated transverse width W determined at the transverse plane location shown in Figure 8 serves as the length of each edge of the inner polygon Pi. Thus, the inner polygon Pi can be determined by multiplying the transverse width W determined at the corresponding transverse plane location by the number of edges equal to the number of joints 114 arranged around the valve in the corresponding transverse plane.

[0166] The outer diameter of the valve can be defined with respect to a circumscribed circle extending over the outer surface defined by the outer support 110o, which is illustrated in Figure 8 by the dotted circumscribed circle surrounding the outer support 110o. The vertices of the inner polygon Pi are offset inward from the outer circumscribed circle by the thickness Th of the frame of the joint 114 between the inner surface of the inner support 110i and the outer surface of the outer support 110o. The thickness Th can include the thickness of the inner support 110i and the thickness of the outer support 110o. In some embodiments, the frame 106 includes washers 132 positioned between the inner support 110i and the outer support 110o at each joint 114 such that the thickness Th also includes the thickness of the washers 132. In some embodiments, the pin 136 or other type of fastener extending through the opening 134 may have a head that extends radially outward beyond the outer surface of the outer post 110o (not shown in Figure 8), resulting in a thickness Th including the additional portion of the pin head, and an overall thickness Th extending between the inner surface of the inner post 110i and the outer surface of the pin 136 head.

[0167] Therefore, the process of estimating the outer diameter of the artificial valve 100 may include estimating the outer diameter at a specific axial position as the diameter of a circumscribed circle that approximates an inner polygon having edges equal in transverse width and length determined with respect to the same plane, wherein the circumscribed circle may be offset from the vertices of the inner polygon by the thickness Th of the joint. In some embodiments, the outer diameter can be estimated by an equation.

[0168]

number

[0169] In the formula, Dc is the desired estimated outer diameter of the artificial valve in the relevant transverse plane (i.e., in the relevant axial position), N is the number of edges of the inner polygon Pi, and N × W is the circumference of the inner polygon Pi. actual L is a known value that has been measured in advance and is a certain length of the outer member, which can be the length of the outer member (or the length of the connecting post) Lp, or the length of the support section Ls. pixels L is the length measured in pixels from the acquired image. actual L pixels The ratio to serves as a calibration for the size of the lateral width W, which can be determined in pixels from the acquired image. The thickness Th of the joint can be at least equal to the sum of the thicknesses of the inner struts 110i and the outer struts 110o, respectively, to compensate for the additional difference between the vertices and circumcircles of the inner polygon Pi.

[0170] The part of the formula other than adding twice the thickness Th can represent the diameter of the circumscribed circle that surrounds the inner polygon Pi and extends along its vertices, which is the inner diameter of the artificial valve 100 in the same transverse plane. Thus, both the inner and outer diameters can be estimated by the above formula, with and without the addition of the offset parameter 2Th.

[0171] Unless otherwise specified, please understand that when referring to any diameter D, it refers to the outer diameter Dc.

[0172] Dc can be estimated at individual axial positions where the lateral width W can be determined based on the lateral joint 114, but the desired outer diameter may be desirable at an axial position other than the same position as a particular joint 114, in which case one or more desired outer diameters can be interpolated or extrapolated from two or more outer diameters estimated at the axial position where the lateral width is determined.

[0173] For example, Figure 7A shows an artificial valve 100 expanded to an aortic annulus 14. The valve outer diameter Da at the annular position should not exceed a maximum value that can be determined, for example, from pre-CT images of a particular patient, in order to reduce the risk of annular rupture. In the embodiment illustrated in Figure 7A, the annular outer diameter Da is located at a position that does not coincide with a particular junction 114 shown in the illustrated example, and is located slightly above (i.e., proximal) the position of the most distal non-apex junction 120c (annotated, for example, in Figure 7B). If at least one outer diameter Dc is estimated in the lateral planes on both sides of the annular position, for example at positions W3 and W4 (which may be the inflow outer diameter Di), the annular outer diameter Da can be extrapolated from there. If at least two outer diameters Dc are estimated in the lateral plane on one side (either proximal or distal) of the valve position, for example at positions W2 and W3, the valve outer diameter Da can be extrapolated from there.

[0174] In some embodiments, the techniques and systems discussed herein can determine the distance / dimension associated with the artificial valve 100 by using one or more algorithms, for example, an algorithm that converts the number of pixels or the distance between pixels in an acquired image into the distance / dimension of the artificial valve 100.

[0175] According to some embodiments, a single outer diameter Dc is estimated by the control circuit 210 and / or the dimension determination component 220 and, if necessary, shown to the user (e.g., physician, technician, radiologist, etc.) via, for example, at least one I / O interface 216 (e.g., display device) and / or stored in the database 226 and / or transmitted via at least one network interface 212. The single outer diameter may be applicable when the artificial valve 100 is expanded into a cylindrical shape having a uniform diameter along its length, or when the desired outer diameter is in a single axial position, and other outer diameters may be estimated for interpolation or extrapolation to the desired single desired outer diameter, but they may not be shown.

[0176] According to some embodiments, multiple outer diameters Do are estimated by the control circuit 210 and / or the dimension determination component 220 and, if necessary, presented to the user (e.g., a physician, technician, radiologist, etc.) via, for example, at least one I / O interface 216 (e.g., a display device), and / or stored in a database 226, and / or transmitted via at least one network interface 212. For example, several outer diameters, e.g., inlet diameter Di, outlet diameter Do, valve ring diameter Da, and potentially another diameter at a different axial position may be estimated and presented to the user.

[0177] A method for estimating at least one outer diameter of an artificial valve may include a series of steps that can be performed during artificial valve expansion. The method may include the step of acquiring one or more images of the artificial valve during valve expansion using an imaging device 202, for example, a fluoroscopy device conventionally used for imaging during artificial valve implantation. A control circuit 210 may receive one or more acquired images (e.g., fluoroscopic images) from the imaging device 202. The acquired images may include components of the artificial valve 100 that may be radiopaque, for example, a frame 106 consisting of a strut 110 and its segments 112, and an expansion and locking assembly 138 that may be attached to the frame 106 as needed.

[0178] The method further includes the step of analyzing acquired images to identify structural components of the artificial valve 100, which can be performed by a control circuit 210 that includes a dimensional determination component 220 and / or an image processing component 224, which can be embodied within the control circuit 210. Identification of structural components may include identification of basic components of the artificial valve 100 and identification of complex structures of the artificial valve 100. For example, identification of basic components may include radiopaque components, such as the strut segments 112, the outer members 140 of the expansion and locking assembly 138, and the joint 114. The joint 114 may be identified as an intersection region between struts 110 by identifying the boundary of an opening 134 extending through it, by identifying a washer 132 positioned between the inner and outer struts, and / or by identifying a pin 136 or other fastener that penetrates the joint (e.g., through the opening 134).

[0179] A complex structure may be a structure that is combined from or contains multiple identified basic components, and may include a cell 108 (e.g., a closed cell) combined from four pillar segments 112 that intersect at four joints 114, and a cell column 130 that may contain several cells 108 aligned perpendicular to each other. Associations between a complex structure, such as a cell 108 or cell column 130, and the basic components contained therein, such as the association between each pillar segment 112 and the cells 108 and / or cell column 130 contained therein, and the association between each joint 114 and the pillar segments 112, cells 108 and / or cell column 130 contained therein can also be identified. Each pillar segment 112 may be shared and associated with two or more cells 108 and two or more cell columns 130. Each joint 114 is associated with two or more support segments 112 (for example, two support segments 112 in the case of a vertex, and four support segments 112 in the case of a non-vertex joint), and can be shared and associated with two or more cells 108 and two or more cell columns 130.

[0180] In some embodiments, the step of analyzing the acquired image to identify structural components further includes classifying at least some of the identified basic components and / or complex structures. In some embodiments, the classifying step includes classifying each identified junction 114 as, for example, an outflow vertex 116, an inflow vertex 118, or a non-vertex junction 120. In some embodiments, the classifying step includes classifying each cell 108 as a closed cell or an open cell 109. In some embodiments, the classifying step includes classifying each cell column 130 as a vertex cell column or a non-vertex cell column.

[0181] In some embodiments, the step of analyzing the acquired image to identify structural components further includes identifying the spatial location of the identified components, for example, basic components, more specifically, the spatial location of, for example, joints 114, and further identifying joints that are aligned laterally to each other. This step can further identify joints that are aligned laterally to each other and belong to the same cell 108 and / or the same cell column 130.

[0182] In some embodiments, the control circuit 210, which includes a dimensional determination component 220 and / or an image processing component 224 that can be incorporated therein, can use one or more image processing techniques that can use one or more models, for example, a machine learning model, a user-learned model, or another model trained to identify and classify features of acquired images.

[0183] In some embodiments, the control circuit 210 can provide a user interface to the user and / or receive input regarding one or more dimensions and / or structural components of the prosthetic valve, including the location and / or classification of the prosthetic valve. For example, the control circuit 210 can generate user interface data representing a user interface including acquired images and / or transmit the user interface data including acquired images to a display device for displaying the user interface. The user can view the acquired images through the interface and provide input to identify the location of structural components, such as joints 114, support segments 112, outer members 140, etc. The user can further classify specific structural components, such as the type of joint 114 and / or joints aligned laterally with each other.

[0184] In one embodiment, the user can specify a first point / location on the image that can be a first joint, and a second point / location on the image that can be a second joint laterally aligned with the first joint, and request that the distance between the first and second joints be calculated, which is the lateral width W. The same can be done for vertically aligned joints to calculate the vertical height. Similarly, the user can specify a first column segment (which in some embodiments may be indicated by pointing to two points / locations through which the column segment penetrates) and a second column segment that intersects it, and request that the opening angle between the first and second column segments be calculated.

[0185] The various steps described above for analyzing the acquired images can be performed in any order. For example, the order of execution may include the identification and classification of the basic components of the artificial valve, and the step of identifying complex structures may be performed after the classification of at least some components, as the classification facilitates the identification of some of the complex structures. Then, classification can be performed again on the identified complex structures. In some cases, the identification of the spatial location of the basic components may be performed before their classification, as the spatial location facilitates such classification (e.g., classifying the junction 114 as the outflow vertex 116, the inflow vertex 118, the nearest non-vertex junction 120a, the most distal non-vertex junction 120c, and other non-vertex junctions 120, etc.).

[0186] Therefore, the method further includes the step of determining at least one dimension of the artificial valve, which is performed by a control circuit, more specifically by a dimensional determination component that can be embedded therein or associated therewith. At least one dimension always includes at least one lateral width W. In some embodiments, several (i.e., two or more) lateral widths W are determined between two laterally spaced joints 114, respectively. In some embodiments, several lateral widths W are determined at different axial positions of the same cell row 130, which can be either a vertex cell row or a non-vertex cell row. In some embodiments, at least two lateral widths W of two different cell rows 130 are determined. For example, one or more lateral widths W can be determined for a first cell row that can be a vertex cell row, and one or more other lateral widths can be determined for a second cell row that can be a non-vertex cell row, and both the vertex and non-vertex cell rows 130 can be adjacent cell rows that can share a portion of the column segment 112 and joint 114.

[0187] The determination of at least one lateral width W can be performed by directly estimating the distance between two laterally aligned joints 114, the two laterally aligned joints can be positioned opposite each other along the same cell (closed cell 108, or open cell 109 in the case of inflow or outflow vertices), or, as described above, by first determining an opening angle that is defined either between intersecting column segments facing the lateral width W, or between the column segments and the lateral width.

[0188] In some embodiments, the step of determining at least one dimension may further include determining at least one vertical height H. In some embodiments, several vertical heights H are determined at different lateral positions of the artificial valve, in which case the method may further include the step of comparing the different vertical heights H to evaluate whether the artificial valve is expanding uniformly or non-uniformly over its circumference, and if the expansion is non-uniform, providing information regarding the degree of non-uniformity of the expansion.

[0189] In some embodiments, the step of analyzing an image to identify structural components of an artificial valve includes identifying structural components of a fixed length, and the method further includes the step of obtaining a pre-stored length of a structural component of a fixed length. For example, an outer member 140 of an expansion and locking assembly 138, or another type of commissure post, either attached to or integrally formed with the frame 106, can be identified as a structural component of a fixed length and thus classified or tagged. The length of the outer member 140 can be pre-stored, for example, in a memory 218 and any of its components (e.g., a database 226), and this pre-stored length Lp of the outer member 140 (or other commissure post) can be retrieved (e.g., from memory) by a control circuit 210 and associated with the identified outer member 140.

[0190] In another embodiment, the support segments 112 can be identified and classified or tagged as structural components of a fixed length. The support segments 112 pivot around the joint 114 during valve expansion, but their lengths remain constant and can be pre-stored, for example, in memory 218 and any of its components (e.g., database 226), and this pre-stored length Ls of the support segments 112 can be retrieved by the control circuit 210 (e.g., from memory) and associated with identified support segments 112 that function as structural components of a fixed length.

[0191] The method further includes the step of estimating at least one outer diameter of the prosthetic valve, performed by a control circuit, based on at least one lateral width W determined at the location of the estimated outer diameter (i.e., at the axial location) and the obtained length associated with an identified constant-length structural component. This estimation can follow the above formula described in relation to Figure 8, which is based on the calculation of the diameter of the circumscribed circle surrounding an approximated inner polygon Pi having a known number of edges N, each having a length equal to the determined lateral width W. The number of edges N is constant and known for a particular type of prosthetic valve and is equal to the number of joints 114 surrounding the frame 106 across the corresponding lateral plane. Figure 8 shows a specific embodiment of an inner polygon Pi having nine edges extending between nine joints 114. The obtained length associated with a constant-length structural component helps to convert distance from pixels to units of length.

[0192] In some embodiments, the step of estimating at least one outer diameter further includes adding the product of the thickness Th of the joint 114 (as shown in the formula above, the product can be twice the thickness Th) to compensate for additional radial displacement of the circumscribed circle from the vertices of the inner polygon Pi.

[0193] In some embodiments, the step of estimating at least one outer diameter includes estimating a plurality of outer diameters based on a lateral width W determined at different axial positions along the length of the artificial valve and at the corresponding axial position of the estimated outer diameter.

[0194] In some embodiments, the step of estimating at least one outer diameter further includes estimating at least one outer diameter at an axial position where the lateral width has not been determined by extrapolating or interpolating at least two outer diameters estimated from the lateral width W determined at that axial position. In some embodiments, at least one outer diameter is extrapolated from at least two outer diameters estimated from the lateral width W determined at one side, for example, the proximal or distal axial position. In some embodiments, at least one outer diameter is interpolated from at least two outer diameters estimated from the lateral width W determined at both sides, i.e., at both the proximal and distal axial positions of the outer diameter.

[0195] In some embodiments, at least one outer diameter includes the inlet diameter Di and / or the outlet diameter Do. In some embodiments, at least one outer diameter includes the valve ring diameter Do.

[0196] Identifying a structural component of a fixed length, obtaining a pre-stored length of a structural component of a fixed length, and associating that length with the identified structural component of a fixed length can be performed at any stage prior to the step of estimating at least one outer diameter.

[0197] The above process can be repeated at several stages of valve expansion to monitor the outer diameter of the valve at a desired axial position(s), such as the valve ring diameter, inlet / outlet diameter, and potentially another diameter in between.

[0198] In some embodiments, a threshold for at least one diameter can be pre-stored, for example, in memory 218 or its components (e.g., database 226) for at least one axial position of the prosthetic valve, or can be manually entered by the user via a user interface provided by the control circuit 210. The threshold may be the maximum allowable dilation diameter at the position of the natural valve annulus (e.g., aortic annulus 14) and may be patient-specific. In some embodiments, such a threshold can be derived from images acquired by an imaging device other than the imaging device 202 described above, prior to valve implantation. This may include, for example, a pre-CT performed before prosthetic valve implantation from which the threshold can be derived.

[0199] According to some embodiments, at least one image acquired by the imaging device 202 includes tissue of an anatomical region in the implantation area, from which the aortic annulus 14 can be identified in a manner similar to that described above for identifying the structural elements of the prosthetic valve 100. In some embodiments, the method includes the steps of identifying the boundary of the natural annulus 14 to which the prosthetic valve should be expanded, and determining the distance between opposing walls of the annulus 14, which indicates the diameter of the natural annulus 14, from which a threshold for the annular diameter Da of the prosthetic valve can be determined.

[0200] According to some embodiments, the estimated outer diameter is compared with a threshold value obtained (e.g., from memory by the control circuit) with respect to the corresponding axial position (e.g., the level of the valve ring), and if the estimated outer diameter exceeds the threshold value, a warning can be generated.

[0201] Throughout the process, the control circuit 210 can generate graphic interface data that can be relayed to a display device. The graphic interface data may include the acquired image, and / or identified structural components, determined dimensions, and / or estimated outer diameters, which can be tagged to the acquired image, graphically overlaid on the image, or displayed separately from the image in any format including text and / or graphical representations.

[0202] The advantages provided by the systems and methods disclosed herein are that they enable continuous real-time diameter monitoring during prosthetic valve expansion, thereby providing clinicians with valuable feedback regarding valve expansion within the natural anatomical structure. This valuable information can help prevent, or at least reduce, potential trauma to tissue (e.g., the annulus). Clinicians can continuously readjust the diameter of the prosthetic valve 100 as needed until it expands to a diameter that best fits the natural annulus. For example, a diameter sufficient to press the prosthetic valve 100 against the surrounding tissue and secure it in place will result in little to no leakage around the valve and will not over-expand the prosthetic valve 100, thus avoiding or reducing the risk of rupture of the natural annulus.

[0203] Here, with reference to Figures 9A-9C, the measurements of different types of prosthetic valves are described. In particular, Figure 9A shows a first partial view of another embodiment of a mechanically expandable prosthetic valve 300, and Figure 9B shows a second partial view of the prosthetic valve 300 with soft components (e.g., skirt and leaflet assembly) removed. Similar to the prosthetic valve 100, the prosthetic valve 300 includes an annular frame 310, which can be a single lattice frame made of a set of intersecting supports 320 defined between the outflow end 302 and the inflow end 304. As shown above with respect to the prosthetic valve 100, a leaflet assembly (not shown), as well as an inner skirt and / or outer skirt, may be provided, but for brevity these components will not be described.

[0204] Unlike artificial valve 100, which is representative of a mechanical valve having two layers of struts hinged together at a cross joint, artificial valve 300 is representative of another valve type that can be expanded using a mechanical mechanism, having a single frame with a single layer of struts, as will be described in more detail below. In some embodiments, artificial valve 300 can be expanded radially by applying an axial force toward the inlet end 304 toward the outlet end 302 while maintaining the inlet end 304 in a fixed position. Alternatively, artificial valve 300 can be expanded by applying an axial force toward the inlet end 304 while maintaining the outlet end 302 in a fixed position, or by applying opposite axial forces toward the inlet end 304 and the outlet end 302, respectively. According to some embodiments, a delivery device (not shown) is provided which may include a plurality of operating assemblies configured to expand and / or compress the artificial valve 300 radially when operated.

[0205] As shown in Figures 9A-B, the artificial valve 300 may include one or more actuators 360 mounted on the inner surface of the frame 310 and spaced equally apart around it. Each of the actuators 360 may be configured to form a releasable connection with the respective operating assembly of a delivery device (not shown).

[0206] The set of interconnected struts 320 of the frame 310 of the artificial valve 300 illustrated in Figures 9A-B comprises curved struts 325, 327, 329, 333 and axial struts or posts 334, 335, 336. The curved struts define a plurality of cells 338 that extend circumferentially around the frame 310. Although only one side of the frame 310 is illustrated in Figures 9A-B, it will be understood that the frame 310 forms an annular structure having substantially the same opposite side as the illustrated portion. In the illustrated embodiment, the frame 310 comprises an outflow strut 324 of the curved strut 325 defining the outflow end 302, a first intermediate strut 326 of the curved strut 327, an intermediate strut 328 of the curved strut 329, and an inflow strut 332 of the curved strut 333 defining the inflow end 304.

[0207] Cell 338 may comprise a first cell 339 and a second cell 340. Each first cell 339 may have an axially extending elliptical shape, comprising an outflow vertex 356 and an inflow vertex 358 located at the principal vertices of the ellipse. Each first cell 339 may further comprise each second cell 340 located within the outer circumference of the first cell 339. The second cell 340 may have a circumferentially extending elliptical shape, comprising a proximal joint 341a and a distal joint 341b located at the minor axis vertices of the ellipse. Each proximal post 335 may extend between its respective outflow vertex 356 and its respective distal end 357. Each distal post 336 may extend between its respective inflow vertex 358 and its respective proximal end 359. Although exemplified as elliptical, it should be understood that any of the cells 338 may have any of various other shapes, such as hexagonal, triangular, teardrop, rectangular, square, oval, etc.

[0208] As described above, the frame 310 may comprise a plurality of axially extending supports or posts, each comprising a plurality of proximal posts 335 and distal posts 336. The proximal posts 335 (shown as upper posts in the exemplary embodiment) may extend to the outflow end 302, and the distal posts 336 (shown as lower posts in the exemplary embodiment) may extend to the inflow end 304. For a pair of proximal and distal posts, each proximal post 335 may be axially aligned with the corresponding distal post 336. One or more pairs of proximal posts 335 and distal posts 336 may constitute an actuator 360. The frame 310 may further comprise another axial support post 334 positioned between each pair of adjacent circumferentially arranged first cells 339, and the actuator 360 may be positioned to extend through the first and second cells, through the vertices 356, 358 and joints 341a, 341b, and to connect to them. The axial support posts 334 can be connected via the curved support columns 325, 327, 329, and 333.

[0209] Each first cell 339 is formed by two curved supports 325 of the valve frame outflow crossbar 324 and two curved supports 333 of the valve frame inflow crossbar 332. Each curved support 325 is connected at one end to the proximal post 335 of the actuator 360 and at the other end to the axial support post 334. Each curved support 333 is connected at one end to the distal post 336 of the actuator 360 and at the other end to the axial support post 334.

[0210] Each second cell 340 is formed by two curved supports 327 of the first intermediate crossbar 326 of the valve frame and two curved supports 329 of the second intermediate crossbar 328 of the valve frame. The lower / distal ends of the curved supports 327 and the upper / proximal ends of the curved supports 329 can be connected to the axial support posts 334. The upper / proximal ends of the curved supports 327 can be connected to the proximal posts 335 of each actuator 360. The lower / distal ends of the curved supports 329 can be connected to the distal posts 336 of each actuator 360.

[0211] Each proximal post 335 can extend through and connect to the outflow vertices 356 and proximal junctions 341a of the first and second cell pairs, respectively. Each distal post 336 can extend through and connect to the inflow vertices 358 and distal junctions 341b of the first and second cell pairs, respectively. In the exemplary embodiment, the frame 310 comprises six first cells 339 extending in a row circumferentially, each first cell 339 comprising a second cell 340, and the six pairs of proximal posts 335 and distal posts 336 each connect to the pairs of cells 339, 340. However, in another embodiment, the frame 310 may comprise more or fewer first cells 339 in the row, and correspondingly more or fewer second cells 340 and / or pairs of posts 335, 336.

[0212] In some embodiments, each pair of posts 335, 336 can be configured as an actuator 360. For example, in the illustrated embodiment, each of the six pairs of posts 335, 336 is configured as an actuator 360. In another embodiment, not all pairs of posts 335, 336 are actuators. When a pair of posts 335, 336 are configured as actuators, the threaded rod 362 extends through each pair of posts 339, 340, resulting in radial compression and expansion of the frame 310. The distal post 336 may be provided with a threaded nut 364 located at its proximal end and configured to engage with the threaded rod 362. When the threaded rod 362 rotates in a first direction (e.g., clockwise), it moves the proximal post 335 and distal post 336 toward each other in corresponding axial directions, thereby expanding the frame 310. When the threaded rod 362 rotates in a second direction (e.g., counterclockwise), it moves the proximal post 335 and distal post 336 toward each other in corresponding axial directions, thereby compressing the frame. When the frame 310 moves from a compressed state to an expanded state, the gap between the proximal post 335 and distal post 336 can be narrowed.

[0213] Since the threaded rod 362 is fixed to the frame 310 at axially separated positions (for example, the outflow end 302 and the inflow end 304), rotating the threaded rod 362 causes the outflow end 302 and the inflow end 304 to move axially relative to each other, thereby expanding or compressing the frame 310 radially. For example, moving the outflow end 302 and the inflow end 304 toward each other shortens the frame 310 axially and expands it radially.

[0214] As shown in Figures 9A and 9B, the axial support posts 334 can extend longitudinally, and each portion of them may be provided with a connecting support member, such as a connecting window 322. The connecting window 322 is illustrated as being located proximal to the axial support post 334, but this is not intended to limit it; in other embodiments, the connecting window 322 may be located at different portions of each axial support post 334. According to some embodiments, one or more axial support posts 334 can extend toward the inlet end 304 via extension members 345. In some embodiments, each extension member 345 terminates with an eyelet 346. As used herein, the term “eyelet” means a small structure having a hole. In the illustrated example, each eyelet 346 is substantially circular, but this is not intended to limit it; each eyelet 346 can have any shape.

[0215] The frame 310 may further have one or more pairs of eyelets 365. In the illustrated example, the eyelets 365 are substantially circular, but this is not intended to limit them, and each eyelet 346 can have any shape. In some embodiments, the eyelets 365 can be used to fasten an outer skirt (not shown). In some embodiments, each eyelet 365 is positioned on each valve frame inlet crossbar 332. In some embodiments, six eyelets 365 are provided, but this is not intended to limit them. In some embodiments, a pair of eyelets 365 are associated with each connecting window 322 such that each pair of eyelets 365 is positioned on the opposite side of each connecting window 322. Figures 9A-B show eyelets 365 on the valve frame inlet crossbar 332, but this is not intended to limit them, and in addition to, or instead of, eyelets may be provided on the valve frame outlet crossbar 324.

[0216] As mentioned above, Figures 9A and 9B show only one side of the frame 310. Although only one axial support post 334 with a connecting window 322 is shown in Figures 9A and 9B, it should be noted that the frame 310 can have any number of axial support posts 334, and any number of axial support posts can have connecting windows 322. For example, the frame 310 can have six axial support posts 334, three of which also have connecting windows 322. In some embodiments, for example, the valve frame can have one, two, three, or four connecting windows.

[0217] When the artificial valve 300 is implanted in a selected implantation site within the patient's body, the patient's natural anatomical structures (e.g., the natural aortic annulus) can exert radial forces on the artificial valve 300 that tend to compress the frame 310. However, the engagement of the threaded rod 362 and threaded nut 364 prevents such forces from compressing the frame 310, thereby ensuring that the frame remains securely locked in a desired radially expanded state.

[0218] Configuration 200 is configured to estimate the diameter of the prosthetic valve 300 during a valve expansion procedure, as described above for the prosthetic valve 100. Similar to the prosthetic valve 100, an image of the prosthetic valve 300 is acquired by the imaging device 202 and analyzed by the control circuit 210 to determine at least one lateral width, e.g., lateral widths X1, X2, X3, X4, or X5. In some embodiments, as shown in Figure 9A, one or more lateral widths X1 are measured between the proximal portions of adjacent axial support posts 334. In some embodiments, as shown in Figure 9A, one or more lateral widths X3 are measured between the distal portions of one or more adjacent pairs of axial support posts 334. In some embodiments, as shown in Figure 9A, one or more lateral widths X2 are measured at both ends of the width of one or more cells 340. In some embodiments, as shown in Figure 9B, one or more lateral widths X4 are measured between adjacent outflow vertices 356. In some embodiments, as shown in Figure 9B, one or more lateral widths X5 are measured between adjacent inflow vertices 358.

[0219] The lateral width is not limited to widths X1 to X5, and other lateral widths can also be measured. In some embodiments, the distance between adjacent nuts 364 is measured as their respective lateral widths. In some embodiments, the nuts 364 have a higher opacity than the opacity of their respective proximal posts 335, so that the control circuit 210 can identify the nuts 364 and measure the distance between them. One or more vertical heights, for example, a vertical height H1 extending between the outflow apex 356 and the inflow apex 358, as shown in Figure 9B, can also be measured.

[0220] The control circuit 210 further analyzes the image to identify one or more structural components of a fixed length. In some embodiments, as shown in Figure 9A, a support post 334 can be identified as a structural component of a fixed length having a length Y1 that can be measured between opposing ends of each axial support post 334 in the acquired image and compared to a pre-stored value. In some embodiments, as shown in Figure 9A, a support post 334 with extension members 345 can be identified in the acquired image as a structural component of a fixed length having a length Y2 that can be measured between the proximal end of each axial support post 334 and the distal end of each extension member 345 extending therefrom and compared to a pre-stored value.

[0221] In some embodiments, as shown in Figure 9B, the proximal post 335 can be identified in the acquired image as a structural component of constant length having a length Y3 that can be measured between the outflow vertex 356 and each distal end 357a and compared with a pre-stored value. In some embodiments, as shown in Figure 9B, the distal post 336 can be identified in the acquired image as a structural component of constant length having a length Y4 that can be measured between the inflow vertex 358 and each proximal end 359 and compared with a pre-stored value.

[0222] The control circuit 210 estimates at least one outer diameter of the artificial valve 300 based at least in part on at least one lateral width determined at the axial position of the estimated outer diameter, and the length of a structural component of a certain length. As described above with respect to the artificial valve 100, if either the inside or outside of the body lumen is incised, the artificial valve 300 may not exhibit a uniform shape, so the outer diameter can be estimated at multiple axial positions.

[0223] In some embodiments, as shown in Figure 9C, multiple determined lateral widths form a polygon. In some embodiments, if the frame 310 has six sides, the multiple determined lateral widths form a hexagon. Figure 9C illustrates a hexagon formed by a lateral width X4, but similar hexagons can be formed by a lateral width X5, or other lateral widths measured at different axial positions. Using the polygon, the diameter of the circle surrounding the polygon can be determined and used to estimate the open diameter of the frame 310. As described above, the diameter of the circle can be determined at multiple axial positions, and the diameter of the frame 310 at multiple axial positions can be estimated. Thus, deformation of the frame 310 can be detected.

[0224] It should be noted that determining these parameters and the axial shape of the frame 310 does not require determining the circle enclosing the polygon. In some embodiments, multiple lateral widths (X1, X2, X3, X4, X5 and / or other widths) are measured and compared to one another. The difference between the measured widths can be used to determine the axial shape of the frame 310.

[0225] As described above in relation to the artificial valve 100, the lateral width can be measured by pixels, and the diameter of the frame 310 can be more accurately estimated using the length of a structural component of a fixed length as a reference. In some embodiments, as described above, one or more structural components of a fixed length comprise one or more support posts 334. In some embodiments, one or more structural components of a fixed length are a combination of a proximal post 335 and a distal post 336.

[0226] In one embodiment, the diameter D of the frame 310 is calculated using the following formula.

number

[0227] As described above, in some embodiments, an eyelet 365 is provided. In such embodiments, the control circuit 210 can identify the eyelet 365 and determine the position of the commissure window 322 based on the position of the eyelet 365. Thus, the artificial valve 300 can be rotated so that the commissure window 322 is positioned in a desired orientation, for example, in a predetermined orientation relative to the natural commissure of the heart. Similarly, in some embodiments, an eyelet 346 of the extension member 345 can be identified by the control circuit 210 and used to adjust the axial position of the artificial valve 300, for example, to position the leaflets of the artificial valve 300 (not shown) relative to the annulus or relative to the position of a previously implanted valve. In one embodiment, position identification can be performed based on both the eyelet 346 and the eyelet 365.

[0228] Additional embodiments of the disclosed technology In consideration of the above-described implementation of the subject matter to be disclosed, this application discloses the following additional embodiments. Note that any feature of an embodiment alone, or any two or more features of an embodiment that are incorporated in combination, or optionally in combination with one or more features of one or more further embodiments, are further embodiments similarly included within the disclosure of this application.

[0229] Example 1. A method for estimating the outer diameter of at least one artificial valve, comprising: acquiring an image of the artificial valve with an imaging device; analyzing the image with a control circuit to determine at least one lateral width; analyzing the image with a control circuit to identify a structural component of a fixed length; acquiring the length of the structural component of a fixed length with a control circuit and relating the length to the identified structural component of a fixed length; estimating the outer diameter of at least one artificial valve at least partially based on the lateral width and the length of the structural component of a fixed length determined at the axial position of the estimated outer diameter; and outputting a display of the estimated at least one outer diameter.

[0230] Example 2. The imaging device is a fluorescence fluoroscopy device, in any embodiment described herein, particularly the method of Example 1.

[0231] Example 3. Any embodiment of the method described herein, particularly Embodiment 1 or 2, wherein the control circuit is communicably coupled to a memory, and the memory stores executable instructions that, when executed by the control circuit, cause the control circuit to perform steps of the method.

[0232] Example 4. Any embodiment described herein, in particular any one of Examples 1 to 3, wherein the step of analyzing an image to determine at least one lateral width further includes identifying structural components of the artificial valve before determining at least one lateral width.

[0233] Example 5. The step of identifying structural components includes identifying the support segments of the artificial valve, as described in any embodiment described herein, in particular the method of Embodiment 4.

[0234] Example 6. The step of identifying structural components includes identifying the joints of the artificial valve, as described in any embodiment of this specification, particularly the method of Example 4 or 5.

[0235] Example 7. Identifying the joint includes identifying the boundary of an opening that extends through the joint, as described in any embodiment of this specification, particularly the method of Embodiment 6.

[0236] Example 8. Identifying the joint includes identifying pins that extend through the joint, as described in any embodiment of this specification, particularly the method of Embodiment 6.

[0237] Example 9. The step of identifying structural components further includes classifying the identified joints as at least one of inlet joints, outlet joints, or non-apex joints, in any embodiment described herein, in particular any one of Examples 6 to 8.

[0238] Example 10. The step of identifying structural components further includes identifying the spatial location of the identified structural components, in any one of the embodiments described herein, particularly any one of Examples 4 to 9.

[0239] Example 11. At least one lateral width extends between two laterally aligned joints, in any embodiment described herein, in particular any one of Examples 6 to 10.

[0240] Example 12. The step of identifying structural components includes identifying at least one cell, in any embodiment described herein, particularly any one of Examples 4 to 11.

[0241] Example 13. The step of identifying structural components further includes classifying the identified cells as closed cells or open cells, as described in any embodiment of this specification, in particular the method of Example 12.

[0242] Example 14. Any embodiment described herein, in particular any one of Examples 12-13, wherein at least one lateral width extends between the laterally aligned joints of two identical cells.

[0243] Example 15. The step of identifying structural components includes identifying at least one cell column, any one of the embodiments described herein, in particular any one of Examples 4 to 14.

[0244] Example 16. The step of identifying structural components further includes classifying the identified cell columns into vertex cell columns or non-vertex cell columns, as described in any embodiment of this specification, in particular the method of Example 15.

[0245] Example 17. Any embodiment described herein, particularly the method of Example 14 or 15, wherein at least one lateral width comprises multiple lateral widths, each positioned at a different axial location along the length of the artificial valve.

[0246] Example 18. Any embodiment described herein, in particular the method of Example 17, wherein at least two of the multiple lateral widths extend between lateral joints connecting to the same cell column.

[0247] Example 19. Any embodiment described herein, in particular the method of Example 17 or 18, wherein at least one identified cell column comprises at least two cell columns, and the plurality of lateral widths comprises at least one lateral width extending between the respective lateral junctions of the two cell columns.

[0248] Example 20. The step of analyzing an image to determine at least one lateral width further includes determining at least one opening angle, the lateral width being calculated from the opening angle and the length of the support segment, any one of the embodiments described herein, in particular any one of Examples 5 to 19.

[0249] Example 21. The opening angle is defined between two intersecting column segments, and the opening angle is opposite to the lateral width, as described in any embodiment of this specification, in particular the method of Embodiment 20.

[0250] Example 22. The opening angle is defined between the column segment and the lateral width, as in any embodiment described herein, particularly the method of Example 20.

[0251] Example 23. The artificial valve comprises a plurality of threaded rods and a plurality of nuts, each nut being screwed onto its respective threaded rod, and the step of identifying the structural components includes identifying the plurality of nuts of the artificial valve, as described herein in any embodiment, particularly the method of Embodiment 4.

[0252] Example 24. At least one lateral width extends between each pair of nuts of the identified artificial valve, as in any embodiment described herein, particularly the method of Embodiment 23.

[0253] Example 25. Any embodiment described herein, in particular any one of Examples 1 to 24, further comprising the step of analyzing an image using a control circuit to determine at least one vertical height.

[0254] Example 26. Any embodiment described herein, in particular the method of Example 25, wherein at least one vertical height includes multiple vertical heights, and the method further includes the step of comparing the vertical heights and generating data indicating whether the expansion of the artificial valve is non-uniform.

[0255] Example 27. A structural component of a certain length is an outer member of an expansion and locking assembly that connects to the frame of the artificial valve, in any embodiment described herein, in particular any one of Examples 1 to 6.

[0256] Example 28. A structural component of a certain length is a support segment of the artificial valve, in any embodiment described herein, in particular any one of Examples 1 to 26.

[0257] Example 29. The step of estimating at least one outer diameter includes calculating the diameter of the circumscribed circle surrounding an inner polygon defined between joints positioned around the artificial valve in a corresponding transverse plane, where the length of each edge of the inner polygon is the transverse width determined at the axial position in the transverse plane, and the calculation further includes a conversion of distance from pixels to length units, at least in part on the length of a structural component of a certain length, any one of the methods of any embodiment described herein, in particular any one of Examples 1 to 28.

[0258] Example 30. The calculation further includes adding the product of the thicknesses of the joints. Any embodiment described herein, in particular the method of Example 29.

[0259] Example 31. Any embodiment described herein, in particular the method of Example 30, further includes the step of performing the same calculation but estimating at least one inner diameter by not adding the product of the thicknesses of the joints.

[0260] Example 32. The step of estimating at least one outer diameter includes estimating at least two outer diameters based on lateral widths determined at different axial positions, according to any of the embodiments described herein, particularly any one of embodiments 1 to 31.

[0261] Example 33. The step of estimating at least one outer diameter further includes estimating at least one outer diameter at an axial position where the lateral width is not determined, according to any of the embodiments herein, particularly the method of embodiment 32.

[0262] Example 34. The outer diameter at an axial position where the lateral width is not determined is extrapolated from at least two outer diameters estimated from the lateral widths determined at axial positions on one side thereof, according to any of the embodiments described herein, particularly the method of embodiment 31.

[0263] Example 35. The outer diameter at an axial position where the lateral width is not determined is interpolated from at least two outer diameters estimated from the lateral widths determined at axial positions on both sides thereof, according to any of the embodiments described herein, particularly the method of embodiment 33.

[0264] Example 36. At least one estimated outer diameter is selected from an inflow diameter, an outflow diameter, and / or a valve ring diameter, according to any of the embodiments described herein, particularly any one of embodiments 1 to 35.

[0265] Example 37. The method further includes identifying one or more markers by a control circuit, identifying one or more commissures of an artificial valve by the control circuit according to the identified one or more markers, and outputting a display of the positions of the identified one or more commissures, according to any of the embodiments described herein, particularly any one of embodiments 1 to 36.

[0266] Example 38. One or more markers comprise a plurality of eyelets, and each pair of eyelets is disposed on opposite surfaces of each intersection, in any of the embodiments described herein, particularly the method of embodiment 37.

[0267] Example 39. Any of the embodiments described herein, particularly any one of the methods of embodiments 1 - 36, further comprising identifying one or more markers by a control circuit and, in response to the identified one or more markers, identifying the position of an artificial valve by the control circuit and outputting a display of the position of the artificial valve.

[0268] Example 40. One or more markers comprise one or more eyelets, and each of the one or more eyelets is disposed on a respective extension member extending from an artificial valve, in any of the embodiments described herein, particularly the method of embodiment 39.

[0269] Example 41. A computing system comprising a control circuit and a memory communicatively coupled to the control circuit and storing executable instructions, the executable instructions, when executed by the control circuit, causing the control circuit to receive an image of an artificial valve acquired by an imaging device, analyze the image to determine at least one lateral width, analyze the image to identify a structural component of a constant length, obtain the length of the structural component of the constant length and associate the length with the identified structural component of the constant length, estimate at least one outer diameter of the artificial valve based at least in part on the at least one lateral width determined at an axial position of the estimated outer diameter and the length of the structural component of the constant length, and output a display of the estimated at least one outer diameter.

[0270] Example 42. The image is a fluoroscopic image, in any of the embodiments described herein, particularly the computing system of embodiment 41.

[0271] Example 43. The computing system of any embodiment described herein, in particular embodiment 41 or 42, further comprises analyzing an image to determine at least one lateral width, and identifying structural components of the artificial valve prior to determining at least one lateral width.

[0272] Example 44. Identifying structural components includes identifying the support segments of an artificial valve, as described in any embodiment of the computing system described herein, particularly in Embodiment 43.

[0273] Example 45. Identifying structural components includes identifying the joints of the artificial valve, as described herein in any embodiment, particularly in Embodiment 43 or 44 of the computing system.

[0274] Example 46. Identifying a joint includes identifying the boundary of an opening that extends through the joint, as described in any embodiment of this specification, particularly the computing system method of Embodiment 45.

[0275] Example 47. Identifying a joint includes identifying pins that extend through the joint, as described in any embodiment of this specification, particularly the computing system method of Embodiment 45.

[0276] Example 48. Identifying structural components further includes classifying the identified joints as at least one of inflow joints, outflow joints, or non-vertex joints, in any embodiment described herein, in particular any computing system among Examples 45 to 47.

[0277] Example 49. Identifying a structural component further includes identifying the spatial position of the identified structural component, in any of the embodiments described herein, particularly in any one of Embodiments 43 to 48 of a computing system.

[0278] Embodiment 50. At least one lateral width extends between two horizontally aligned joints, in any of the embodiments described herein, particularly in any one of Embodiments 45 to 49 of a computing system.

[0279] Embodiment 51. Identifying a structural component includes identifying at least one cell, in any of the embodiments described herein, particularly in any one of Embodiments 43 to 50 of a computing system.

[0280] Embodiment 52. Identifying a structural component further includes classifying the identified cell as a closed cell or an open cell, in any of the embodiments described herein, particularly in the computing system of Embodiment 51.

[0281] Embodiment 53. At least one lateral width extends between two horizontally aligned joints of two same cells, in any of the embodiments described herein, particularly in the computing system of Embodiment 47 or 48.

[0282] Embodiment 54. Identifying a structural component includes identifying at least one cell column, in any of the embodiments described herein, particularly in any one of Embodiments 43 to 53 of a computing system.

[0283] Embodiment 55. Identifying a structural component further includes classifying the identified cell column as a vertex cell column or a non-vertex cell column, in any of the embodiments described herein, particularly in the computing system of Embodiment 54.

[0284] Example 56. A computing system of any embodiment described herein, particularly embodiment 54 or 55, wherein at least one lateral width comprises multiple lateral widths, each positioned at a different axial location along the length of the artificial valve.

[0285] Example 57. A computing system according to any embodiment described herein, in particular Example 56, wherein at least two of the multiple lateral widths extend between lateral junctions connecting to the same cell column.

[0286] Example 58. A computing system of any embodiment described herein, in particular embodiment 56 or 57, wherein at least one identified cell column comprises at least two cell columns, and the plurality of lateral widths comprises at least one lateral width extending between the respective lateral junctions of the two cell columns.

[0287] Example 59. Analyzing an image to determine at least one lateral width further includes determining at least one aperture angle, the lateral width being calculated from the aperture angle and the length of the support segment, in any embodiment described herein, in particular one of embodiments 44-58 of the computing system.

[0288] Example 60. The opening angle is defined between two intersecting column segments, and the opening angle is opposite to the lateral width, in any embodiment described herein, in particular the computing system of Embodiment 59.

[0289] Example 61. The opening angle is defined between the column segment and the lateral width, in any embodiment described herein, particularly the computing system of Embodiment 59.

[0290] Example 62. The artificial valve comprises a plurality of threaded rods and a plurality of nuts, each nut being screwed onto its respective threaded rod, and the identification of the structural components includes identifying the plurality of nuts of the artificial valve, as described herein in any embodiment, in particular the computing system of Embodiment 43.

[0291] Example 63. At least one lateral width extends between each pair of nuts of the identified artificial valve, in any embodiment described herein, in particular the computing system of Embodiment 62.

[0292] Example 64. The process further includes analyzing an image to determine at least one vertical height in any of the embodiments described herein, in particular any one of the computing systems from Examples 41 to 63.

[0293] Example 65. Any embodiment described herein, particularly the computing system of Example 64, wherein at least one vertical height includes multiple vertical heights, and the process further includes comparing the vertical heights and generating data indicating whether the expansion of the artificial valve is non-uniform.

[0294] Example 66. A computing system in any embodiment described herein, particularly one of embodiments 41 to 65, wherein a structural component of a fixed length is an outer member of an expansion and locking assembly that connects to the frame of an artificial valve.

[0295] Example 67. A computing system in any embodiment described herein, particularly one of Examples 41 to 65, in which a structural component of a fixed length is a support segment of an artificial valve.

[0296] Example 68. Estimating at least one outer diameter involves calculating the diameter of the circumscribed circle surrounding an inner polygon defined between the joints positioned around the artificial valve in a corresponding transverse plane, where the length of each edge of the inner polygon is the transverse width determined at the axial position in the transverse plane, and the calculation further involves a conversion of distance from pixels to length units, at least in part on the length of a structural component of a certain length, in any one of the computing systems described herein, in particular examples 41 to 67.

[0297] Example 69. The calculation further includes adding the product of the thicknesses of the joints. Any embodiment described herein, in particular the computing system of Example 68.

[0298] Example 70. The computing system of any embodiment described herein, in particular Example 69, further includes the step of estimating at least one internal diameter by performing the same calculation but without adding the product of the thicknesses of the joints.

[0299] Example 71. Estimating at least one outer diameter includes estimating at least two outer diameters based on lateral widths determined at different axial positions, in any embodiment described herein, particularly any one of Examples 41 to 70 of the computing system.

[0300] Example 72. Estimating at least one outer diameter further includes estimating at least one outer diameter at an axial position where the lateral width has not been determined, in any embodiment of this specification, in particular the computing system of Embodiment 71.

[0301] Example 73. The computing system of any embodiment described herein, in particular Embodiment 72, wherein the outer diameter at an axial position where the lateral width is not determined is extrapolated from at least two outer diameters estimated from the lateral width determined at one axial position.

[0302] Example 74. The computing system of any embodiment described herein, in particular Embodiment 72, wherein the outer diameter at an axial position where the lateral width is not determined is interpolated from at least two outer diameters estimated from the lateral widths determined at the axial positions on either side thereof.

[0303] Example 75. At least one estimated outer diameter is selected from the inlet diameter, outlet diameter, and / or valve ring diameter, in any embodiment described herein, in particular any one of the computing systems from Examples 41 to 74.

[0304] Example 76. A computing system, any embodiment described herein, in particular any one of Examples 41 to 75, further comprising the steps of: identifying one or more markers; identifying one or more commissures of an artificial valve in accordance with the identified one or more markers; and outputting an indication of the location of the identified one or more commissures.

[0305] Example 77. One or more markers comprise a plurality of eyelets, each pair of eyelets positioned on the opposing surfaces of each crossing, in any embodiment described herein, particularly the computing system of Embodiment 76.

[0306] Example 78. The process further includes identifying one or more markers, identifying the location of an artificial valve in accordance with the identified one or more markers, and outputting an indication of the location of the artificial valve, any one of any embodiment described herein, in particular any one of Examples 41 to 75.

[0307] Example 79. One or more markers comprise one or more eyelets, each of which is positioned on an extension member extending from an artificial valve, in any embodiment described herein, particularly the computing system of Embodiment 78.

[0308] Example 80. A method for identifying the location of one or more commissures of an artificial valve, comprising: acquiring an image of the artificial valve with an imaging device; analyzing the image with a control circuit to identify one or more markers; identifying one or more commissures of the artificial valve according to the identified one or more markers; and outputting a display of the location of the identified one or more commissures.

[0309] Example 81. One or more markers comprise a plurality of eyelets, each pair of eyelets positioned on the opposing surfaces of each crossing, as described in any embodiment of this specification, particularly the method of Embodiment 80.

[0310] Example 82. A computing system comprising a control circuit and a memory communicatively coupled to the control circuit and storing executable instructions, wherein the executable instructions, when executed by the control circuit, cause the control circuit to perform the following steps: receiving an image of an artificial valve from an imaging device; analyzing the image to identify one or more markers; identifying one or more commissures of the artificial valve according to the identified one or more markers; and outputting an indication of the location of the identified one or more commissures.

[0311] Example 83. One or more markers comprise a plurality of eyelets, each pair of eyelets positioned on the opposing surfaces of each commissar, in any embodiment described herein, particularly the computing system of Embodiment 82.

[0312] Example 84. A method for identifying the location of an artificial valve, comprising: acquiring an image of the artificial valve with an imaging device; analyzing the image with a control circuit to identify one or more markers; identifying the location of the artificial valve according to the identified one or more markers; and outputting a display of the location of the artificial valve.

[0313] Example 85. One or more markers comprises one or more eyelets, each of which is positioned on an extension member extending from the frame of the artificial valve, as described in any embodiment of this specification, particularly the method of Embodiment 84.

[0314] Example 87. A computing system comprising a control circuit and a memory communicatively coupled to the control circuit and storing executable instructions, wherein the executable instructions, when executed by the control circuit, cause the control circuit to perform the following steps: receiving an image of an artificial valve from an imaging device; analyzing the image to identify one or more markers; identifying the position of the artificial valve according to the identified one or more markers; and outputting a display of the position of the artificial valve.

[0315] Example 88. One or more markers comprise one or more eyelets, each of which is positioned on an extension member extending from the frame of the artificial valve, in any embodiment described herein, particularly the computing system of Embodiment 87.

[0316] For clarity, it is understood that certain features of the Disclosure described in the context of separate embodiments may be provided in combination in a single embodiment. Conversely, for brevity, various features of the Disclosure described in the context of a single embodiment may also be provided separately, in any preferred partial combination, or as preferred in any other described embodiment of the Invention. Features described in the context of an embodiment should not be considered essential features of that embodiment unless expressly designated as such an embodiment.

[0317] While the present invention is described in conjunction with its specific embodiments, it is evident that numerous alternatives, modifications, and variations are available, as will be apparent to those skilled in the art. It should be understood that the present invention is not necessarily limited in its application to the structural and arrangement details and / or methods of the components described herein. Other embodiments can be implemented, and these embodiments can be implemented in a variety of ways. Therefore, the present invention encompasses all such alternatives, modifications, and variations within the scope of the appended claims. Further aspects of the present invention are provided by the subject matter of the following sections. [Section 1] A computing system, Control circuit and A memory that is communicatively coupled to the control circuit and executed by the control circuit, the control circuit Receiving images of the artificial valve acquired by the imaging device, The aforementioned image is analyzed to determine at least one horizontal width, The aforementioned image is analyzed to identify structural components of a certain length, Obtain the length of the structural component of the aforementioned fixed length, and associate the length with the identified structural component of the aforementioned fixed length. Estimating the outer diameter of the artificial valve based at least partially on the length of the structural component of the constant length and the lateral width of the at least one component determined at the axial position of the estimated outer diameter, A computing system including memory and a memory that stores executable instructions for performing a process including outputting a display of at least one estimated outer diameter. [Section 2] The computing system according to item 1, wherein analyzing the image to determine at least one lateral width further includes identifying structural components of the artificial valve before determining at least one lateral width. [Section 3] The computing system according to claim 1 or 2, wherein identifying structural components includes identifying the joints of the artificial valve. [Section 4] The computing system according to any one of claims 1 to 3, wherein identifying a structural component includes identifying at least one cell, the lateral width of which extends between two laterally aligned junctions of the same cell. [Section 5] The computing system according to any one of claims 1 to 4, wherein the at least one transverse width comprises a plurality of transverse widths, each positioned at a different axial position along the length of the artificial valve. [Explanation of symbols]

[0318] 100 artificial valves 102 Outlet end 104 Inflow end 106 Annular Frame 108 Close Cell 109 Open Cells 110 Metal post 112 support segment 114 components 116 Outflow peak 118 Inflow peak 120 Non-vertex joints 122 Inner skirt 124 Valve leaflet assembly 126 Valve Leaflet 128 Commissure 130 cell columns 132 Washer 134 Opening 136 pins 138 Locking Assembly 140 Outer member 142 Lumens of the outer component 144 Proximal end 146 Distal end 148 Connection extension 150 biasing arm 154 Inner member 156 Proximal end 158 Distal end 160 Bore 162 Connection extension 164 ratchet teeth 170 Actuating Assembly 172 Actuators 174 Distal end 176 sleeves 178 Distal lip 200 configurations 202 Fluorescence Fluoroscopy Apparatus 204 patients 206 Computing Systems 210 Control circuits 212 Network Interfaces 214 Imaging Components 216 I / O interfaces 218 memory 220 Dimension Determination Components 221 Components 222 Components 223 Components 224 Components 226 Databases 300 artificial valves 302 Outlet end 304 Inflow end 310 Ring Frame 320 sets 322 Interconnecting window 324 Valve frame outflow crossbar 325 Curved support column 326 First intermediate horizontal bar 327 Curved support column 328 Second intermediate horizontal bar 329 Curved support column 332 Valve frame inlet crossbar 333 Curved support column 334 Axial support post 335 Proximal Post 336 Distal Post 338 cells 339 cells 340 cells 345 Extension member 346 Eyelets 356 Outflow peak 357 Distal end 358 Inflow peak 359 Proximal end 360 Actuator 362 bars 364 nuts 365 Eyelets

Claims

1. A method for estimating the outer diameter of at least one artificial valve, The process of acquiring an image of the artificial valve, A step of analyzing the aforementioned image and determining at least one lateral width, wherein the at least one lateral width extends between two laterally aligned joints of the same cell, The aforementioned image is analyzed to identify structural components of a certain length, A step of obtaining the length of the structural component of a certain length and associating the length with the identified structural component of a certain length, A step of estimating the outer diameter of the artificial valve based at least partially on the lateral width of the at least one determined at the axial position of the estimated outer diameter and the length of the constant-length structural component, A method comprising the step of outputting a representation of at least one estimated outer diameter.

2. The method according to claim 1, wherein the step of analyzing the image to determine at least one lateral width further includes the step of identifying structural components of the artificial valve before determining at least one lateral width.

3. The method according to claim 2, wherein the step of identifying structural components includes the step of identifying the support segment of the artificial valve.

4. The method according to claim 2 or 3, wherein the step of identifying structural components includes the step of identifying the joint of the artificial valve.

5. The method according to any one of claims 2 to 4, wherein the step of identifying structural components includes identifying at least one cell.

6. The method according to claim 5, wherein the at least one identified cell comprises at least two cell columns, and the at least one lateral width comprises a plurality of lateral widths extending between the lateral junctions of each of the two cell columns.

7. The method according to any one of claims 2 to 6, wherein the step of analyzing the image to determine at least one lateral width further includes the step of determining at least one opening angle defined between two intersecting column segments, wherein the opening angle faces the lateral width and the lateral width is calculated from the opening angle and the length of the column segments.

8. The method according to any one of claims 2 to 6, wherein the step of analyzing the image to determine at least one lateral width further includes the step of determining at least one opening angle defined between the support segment and the lateral width, and the lateral width is calculated from the opening angle and the length of the support segment.

9. The method according to any one of claims 2 to 8, wherein the artificial valve comprises a plurality of threaded rods and a plurality of nuts, each nut being screwed onto its respective threaded rod, and the step of identifying structural components includes the step of identifying the plurality of nuts of the artificial valve, wherein the at least one lateral width extends between each pair of identified nuts of the artificial valve.

10. The method according to any one of claims 1 to 5, wherein the at least one lateral width includes a plurality of lateral widths, each of which is positioned at a different axial position along the length of the artificial valve.

11. The method according to any one of claims 1 to 10, further comprising the step of analyzing the image by a control circuit to determine at least one vertical height, wherein the at least one vertical height includes a plurality of vertical heights, and the method further comprises the step of comparing the vertical heights and generating data indicating whether the expansion of the artificial valve is non-uniform.

12. The method according to any one of claims 1 to 11, wherein the structural component of a certain length is an outer member of an expansion and locking assembly that connects to the frame of the artificial valve.

13. The method according to any one of claims 1 to 11, wherein the structural component of a certain length is a support segment of the artificial valve.

14. The method according to any one of claims 1 to 13, wherein the step of estimating at least one outer diameter includes the step of calculating the diameter of a circumscribed circle surrounding an inner polygon defined between joints arranged around the artificial valve in a corresponding transverse plane, the length of each of the edges of the inner polygon being the transverse width determined at the axial position in the transverse plane, and the calculation further includes a conversion of distance from pixels to length units, at least in part on the length of the constant length structural component.

15. The method according to any one of claims 1 to 14, wherein the step of estimating at least one outer diameter includes the step of estimating at least two outer diameters based on lateral widths determined at different axial positions.

Images