Medical device diameter determination

Abstract

A method of determining an expected expansion diameter of an expandable medical device, constituted of: receiving one or more images showing the medical device being expanded; identifying one or more features of the medical device; based at least in part on the identified one or more features, determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken; based at least in part on the determined image diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the imaging time; and outputting information regarding the determined expected expansion diameter of the medical device.

Description

Attorney Docket No: TH VYA- 13387 WO01MEDICAL DEVICE DIAMETER DETERMINATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of: U.S. Provisional Application No. 63 / 717,463, filed November 7, 2024; U.S. Provisional Application No. 63 / 723,303, filed November 21, 2024; and U.S. Provisional Application No. 63 / 885,762, filed September 22, 2025, each of which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to apparatuses and methods that can be used in the treatment of various diseases, including the delivery of prosthetic valves.BACKGROUND

[0003] Heart valve disease is a serious problem that involves the malfunction of one or more valves of the heart. The malfunction can manifest itself in a variety of manners. For example, valve stenosis is the calcification or narrowing of a native heart valve. As a result, the native heart valve is not able to completely open and blood flow through the native valve is impeded or restricted. Another example of heart valve disease is valve insufficiency. Valve insufficiency is the failure of a native heart valve to close properly to prevent leaking, or backflow, of blood through the valve.

[0004] Surgical procedures can be performed to repair or replace a heart valve. Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

[0005] Different types of prosthetic valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves. Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve. One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, toward the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.Attorney Docket No: TH VYA- 13387 WO01

[0006] A prosthetic valve conventionally includes a circumferential frame that can be a metallic frame configured to transition between compressed and expanded states, and soft components sutured thereto, such as a leaflet assembly composed of a plurality of leaflets attached to the frame via a plurality of commissure assemblies, and configured to regulate blood flow through the prosthetic valve, as well as a skirt that can prevent perivalvular leakage as further serve as an intermediate means of attachment of the leaflet assembly, along a lower scalloped edge thereof, to the frame.SUMMARY

[0007] When implanting a medical device, such as a balloon expandable valve, it is desirable to expand the valve to a maximum size allowed by the patient's anatomical considerations, in order to avoid paravalvular leakage or other unfavorable hemodynamic phenomena across the valve that may be associated with a mismatch between the valve's expansion diameter and the surrounding tissue, while mitigating the risk of annular rupture that may result from overexpansion.

[0008] One potential technique for mitigating the risk of mismatch between a prosthetic valve's expansion diameter and the surrounding tissue, such as the diameter of a native annulus, involves measuring, in real-time, the valve's expansion diameter.

[0009] In some examples, a method of determining an expected expansion diameter of an expandable medical device is provided, the method comprising receiving one or more images showing the medical device being expanded. In some examples, for each of the received one or more images, the method comprises identifying one or more features of the medical device. In some examples, for each of the received one or more images, based at least in part on the identified one or more features, the method comprises determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken. In some examples, based at least in part on the determined image diameter of the medical device and one or more recoil values, the method comprises determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the prosthetic valve would recoil at the imaging time. In some examples, for at least one of the one or more images, the method comprises outputting information regarding the determined expected expansion diameter of the medical device.

[0010] In some examples, a method of determining an expected expansion diameter of an expandable medical device during expansion thereof is provided, the method comprising,Attorney Docket No: TH VVA- 13387 WOOl during expansion of the medical device, receiving one or more sets of signals associated with the medical device. In some examples, for each of the received one or more sets of signals, the method comprises determining a signal diameter of the medical device, the signal diameter being the diameter of the medical device at a sampling time when the set of signals was generated. In some examples, based at least in part on the determined signal diameter of the medical device and one or more recoil values, the method comprises determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the sampling time. In some examples, for at least one of the one or more sets of signals, the method comprises outputting information regarding the determined expected expansion diameter of the medical device.

[0011] In some examples, a method of ovality determination in an expandable medical device is provided, the method comprising receiving an expansion image showing the medical device being expanded. In some examples, the method comprises receiving an implant image showing the medical device after recoil. In some examples, for each of the received images, the method comprises identifying one or more features of the medical device. In some examples, based at least in part on the identified one or more features of the medical device in the expansion image, the method comprises determining a pre-recoil diameter of the medical device, the pre -recoil diameter being the diameter of the medical device at an imaging time when the expansion image was taken. In some examples, based at least in part on the identified one or more features of the medical device in the implant image, the method comprises determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at an imaging time when the implant image was taken. In some examples, based at least in part on a difference between the determined pre-recoil diameter and the determined postrecoil diameter, and one or more recoil values, the method comprises determining whether the expanded medical device exhibits an ovality. In some examples, the method comprises outputting information regarding the ovality determination.

[0012] In some examples, a method of ovality determination in an expandable medical device is provided, the method comprising, during expansion of the medical device, receiving a first set of signals associated with the medical device. In some examples, after implantation of the medical device, the method comprises receiving a second set of signals associated with the medical device. In some examples, based at least in part on the received first set of signals, the method comprises determining a pre-recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at a first sampling time when the first set ofAttorney Docket No: TH VVA- 13387 WO01 signals was generated. In some examples, based at least in part on the received second set of signals, the method comprises determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at a second sampling time when the second set of signals was generated. In some examples, based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoil values, the method comprises determining whether the implanted medical device exhibits an ovality. In some examples, the method comprises outputting information regarding the ovality determination.

[0013] In some examples, a method of ovality determination in a medical device is provided, the method comprising receiving a plurality of images showing the medical device, each of the plurality of images taken at a different orientation. In some examples, for each of the received images, the method comprises identifying one or more features of the medical device. In some examples, for each of the received images, based at least in part on the identified one or more features of the medical device in the respective image, the method comprises determining one or more diameters of the medical device. In some examples, based at least in part on the determined diameters, the method comprises determining whether the implanted medical device exhibits an ovality; In some examples, the method comprises outputting information regarding the ovality determination.

[0014] In some examples, a method of determining a height variance in an expandable medical device is provided, the method comprising receiving a 2-dimensional image showing the medical device in an expanded state in an image plane. In some examples, the method comprises identifying within the image a plurality of axial frame members of the medical device. In some examples, the method comprises measuring a length of each of the plurality of identified axial frame members. In some examples, based at least in part on the measured lengths, the method comprises determining a position of each of the plurality of axial frame members in relation to the image plane. In some examples, based at least in part on the determining positions of the plurality of axial frame members, the method comprises determining a plurality of heights of the medical device. In some examples, based at least in part on the determined heights of the medical device, the method comprises determining a height variance in the medical device. In some examples, the method comprises outputting information regarding the determined height variance.

[0015] In some examples, a method of determining a regional under-expansion of an expandable medical device is provided, the method comprising receiving a 2-dimensional image showing the medical device in an expanded state in an image plane. In some examples,Attorney Docket No: TH VVA- 13387 WOOl the method comprises identifying within the image a plurality of axial frame members of the medical device. In some examples, the method comprises measuring a length of each of the plurality of identified axial frame members. In some examples, based at least in part on the measured lengths, the method comprises determining a position of each of the plurality of axial frame members in relation to the image plane. In some examples, based at least in part on the determining positions of the plurality of axial frame members, the method comprises determining a plurality of arclengths extending between the identified axial frame members. In some examples, based at least in part on the determined arclengths, the method comprises determining a regional under-expansion of the medical device. In some examples, the method comprises outputting information regarding the determined regional under-expansion.

[0016] In some examples, a method of determining a diameter of an expandable medical device during expansion thereof is provided, the method comprising receiving an image showing the medical device being expanded. In some examples, the method comprises utilizing a parameter identification neural network (NN) to identify within the received image a first plurality of parameters defining a respective ellipse at a first portion of the medical device. In some examples, based at least in part on the identified first plurality of parameters, the method comprises determining a diameter of the medical device. In some examples, the method comprises outputting information regarding the determined diameter.

[0017] In some examples, a system for determining an expected expansion diameter of an expandable medical device is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving one or more images showing the medical device being expanded. In some examples, for each of the received one or more images, the plurality of steps comprise identifying one or more features of the medical device. In some examples, for each of the received one or more images, based at least in part on the identified one or more features, the plurality of steps comprise determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken. In some examples, based at least in part on the determined image diameter of the medical device and one or more recoil values, the plurality of steps comprise determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the imaging time. In some examples, for at least one of the one or more images, the plurality ofAttorney Docket No: TH VVA- 13387 WOOl steps comprise outputring information regarding the determined expected expansion diameter of the medical device.

[0018] In some examples, a system for determining an expected expansion diameter of an expandable medical device during expansion thereof is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising, during the expansion of the medical device, receiving one or more sets of signals associated with the medical device. In some examples, for each of the received one or more sets of signals, the plurality of steps comprise determining a signal diameter of the medical device, the signal diameter being the diameter of the medical device at a sampling time when the set of signals was generated. In some examples, based at least in part on the determined signal diameter of the medical device and one or more recoil values, the plurality of steps comprise determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the sampling time. In some examples, for at least one of the one or more sets of signals, the plurality of steps comprise outputting information regarding the determined expected expansion diameter of the medical device.

[0019] In some examples, a system for ovality determination in an expandable medical device, is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving an expansion image showing the medical device being expanded. In some examples, the plurality of steps comprise receiving an implant image showing the expanded medical device after recoil. In some examples, for each of the received images, the plurality of steps comprise identifying one or more features of the medical device. In some examples, based at least in part on the identified one or more features of the medical device in the expansion image, the plurality of steps comprise determining a pre-recoil diameter of the medical device, the prerecoil diameter being the diameter of the medical device at an imaging time when the expansion image was taken. In some examples, based at least in part on the identified one or more features of the medical device in the implant image, the plurality of steps comprise determining a postrecoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at an imaging time when the implant image was taken. In some examples, based at least in part on a difference between the determined pre-recoil diameter and the determinedAttorney Docket No: TH VVA- 13387 WO01 post-recoil diameter, and one or more recoil values, the plurality of steps comprise determining whether the implanted medical device exhibits an ovality. In some examples, the plurality of steps comprise outputting information regarding the ovality determination.

[0020] In some examples, a system for ovality determination in an expandable medical device is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising, during expansion of the medical device, receiving a first set of signals associated with the medical device. In some examples, after the expansion of the medical device, the plurality of steps comprise receiving a second set of signals associated with the medical device. In some examples, based at least in part on the received first set of signals, the plurality of steps comprise determining a pre-recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at a first sampling time when the first set of signals was generated. In some examples, based at least in part on the received second set of signals, the plurality of steps comprise determining a post-recoil diameter of the medical device, the postrecoil diameter being the diameter of the medical device at a second sampling time when the second set of signals was generated. In some examples, based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoil values, the plurality of steps comprise determining whether the implanted medical device exhibits an ovality. In some examples, the plurality of steps comprise outputting information regarding the ovality determination.

[0021] In some examples, a system for ovality determination in a medical device is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving a plurality of images showing the medical device, each of the plurality of images taken at a different orientation. In some examples, for each of the received images, the plurality of steps comprise identifying one or more features of the medical device. In some examples, for each of the received images, based at least in part on the identified one or more features of the medical device in the respective image, the plurality of steps comprise determining one or more diameters of the medical device. In some examples, based at least in part on the determined diameters, the plurality of steps comprise determining whether the implanted medical device exhibits an ovality; In some examples, the plurality of steps comprise outputting information regarding the ovality determination.Attorney Docket No: TH VVA- 13387 WOOl

[0022] In some examples, a system for determining a height variance in an expandable medical device is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving a 2-dimensional image showing the medical device in an expanded state in an image plane. In some examples, the plurality of steps comprise identifying within the image a plurality of axial frame members of the medical device. In some examples, the plurality of steps comprise measuring a length of each of the plurality of identified axial frame members. In some examples, based at least in part on the measured lengths, the plurality of steps comprise determining a position of each of the plurality of axial frame members in relation to the image plane. In some examples, based at least in part on the determining positions of the plurality of axial frame members, the plurality of steps comprise determining a plurality of heights of the medical device. In some examples, based at least in part on the determined heights of the medical device, the plurality of steps comprise determining a height variance in the medical device. In some examples, the plurality of steps comprise outputting information regarding the determined height variance.

[0023] In some examples, a system for determining a regional under-expansion of an expandable medical device is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving a 2-dimensional image showing the medical device in an expanded state in an image plane. In some examples, the plurality of steps comprise identifying within the image a plurality of axial frame members of the medical device. In some examples, the plurality of steps comprise measuring a length of each of the plurality of identified axial frame members. In some examples, based at least in part on the measured lengths, the plurality of steps comprise determining a position of each of the plurality of axial frame members in relation to the image plane. In some examples, based at least in part on the determining positions of the plurality of axial frame members, the plurality of steps comprise determining a plurality of arclengths extending between the identified axial frame members. In some examples, based at least in part on the determined arclengths, the plurality of steps comprise determining a regional under-expansion of the medical device. In some examples, the plurality of steps comprise outputting information regarding the determined regional underexpansion.Attorney Docket No: TH VVA- 13387 WO01

[0024] In some examples, a system for determining a diameter of an expandable medical device during expansion thereof is provided, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising receiving an image showing the medical device being expanded. In some examples, the plurality of steps comprise utilizing a parameter identification neural network (NN) to identify within the received image a first plurality of parameters defining a respective ellipse at a first portion of the medical device. In some examples, based at least in part on the identified first plurality of parameters, the plurality of steps comprise determining a diameter of the medical device. In some examples, the plurality of steps comprise outputting information regarding the determined diameter.

[0025] In some examples, a system for identifying spatial orientation of a medical device in fluoroscopic images is provided, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps. In some examples, the plurality of steps comprises receiving a plurality of sequential images showing a medical device frame. In some examples, the plurality of steps comprises identifying a plurality of points on the medical device frame in each of the plurality of sequential images. In some examples, the plurality of steps comprises measuring displacement of the plurality points between the sequential images. In some examples, the plurality of steps comprises classifying portions of the medical device frame as front or rear based at least in part on the measured displacements.

[0026] In some examples, a system for identification of medical device specifications prior to diameter measurement is provided, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps. In some examples the plurality of steps comprises receiving an image showing the medical device. In some examples, the plurality of steps comprises identifying within the image identification features associated with the medical device. In some examples, the plurality of steps comprises comparing the identification features to stored data of valve types in the memory. In some examples, the plurality of steps comprises, based at least in part on an outcome of the comparison, determining a diameter of the medical device.

[0027] In some examples, a system for selective presentation of diameter measurements of an expandable medical device is provided, wherein the system comprises: a memory; and one orAttorney Docket No: TH VVA- 13387 WOOl more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps. In some examples, the plurality of steps comprises receiving a target expansion diameter for a medical device. In some examples, the plurality of steps comprises, during expansion of the medical device, determining a current diameter of the medical device. In some examples, the plurality of steps comprises determining whether the current diameter exceeds a predetermined threshold percentage of the target expansion diameter. In some examples, the plurality of steps comprises outputting diameter information when the current diameter exceeds the predetermined threshold percentage of the target expansion diameter.

[0028] In some examples, a system for determining diameter measurements of an expandable medical device having a frame configured to maintain a constant height throughout expansion is provided, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps. In some examples, the plurality of steps comprise receiving one or more images showing the medical device during expansion thereof. In some examples, the plurality of steps comprises measuring the height of the frame at multiple locations within the one or more images, the multiple locations comprising front and rear portions of the frame. In some examples, the plurality of steps comprises calculating an average of the measured heights from the multiple locations. In some examples, the plurality of steps comprises establishing a pixel-to-millimeter conversion factor by comparing the measured heights to a known physical height of the frame. In some examples, the plurality of steps comprises determining a diameter of the medical device using the established pixel-to- millimeter conversion factor.

[0029] In some examples, a system for determining dimensions of a medical device within an image is provided, wherein the medical device has a plurality of markers disposed thereon defining at least one ellipse. In some examples, the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps. In some examples, the plurality of steps comprises receiving one or more images showing the medical device. In some examples, the plurality of steps comprises determining a tilt angle of the medical device based on a ratio between minor and major ellipse diameters of the at least one ellipse. In some examples, the plurality of steps comprises measuring one or more dimensions of the medical device. In some examples, the plurality of steps comprises correcting the measured one or more dimensions based at least in part on the determined tilt angle.Attorney Docket No: TH VVA- 13387 WO01

[0030] In some examples, a method for identifying spatial orientation of a medical device frame in fluoroscopic images is provided. In some examples, the method comprises receiving a plurality of sequential images showing a medical device frame. In some examples, the method comprises identifying a plurality of points on the medical device frame in each of the plurality of sequential images. In some examples, the method comprises measuring displacement of the plurality of points between the sequential images. In some examples, the method comprises classifying portions of the medical device frame as front or rear based at least in part on the measured displacements.

[0031] In some examples, a method for identification of medical device specifications prior to diameter measurement is provided. In some examples, the method comprises receiving an image showing the medical device. In some examples, the method comprises identifying within the image identification features associated with the medical device. In some examples, the method comprises comparing the identification features to stored data of valve types. In some examples, the method comprises, based at least in part on an outcome of the comparison, determining a diameter of the medical device.

[0032] In some examples, a method for selective presentation of diameter measurements of an expandable medical device is provided. In some examples, the method comprises receiving a target expansion diameter for a medical device. In some examples, the method comprises, during expansion of the medical device, determining a current diameter of the medical device. In some examples, the method comprises determining whether the current diameter exceeds a predetermined threshold percentage of the target expansion diameter. In some examples, the method comprises outputting diameter information when the current diameter exceeds the predetermined threshold percentage of the target expansion diameter.

[0033] In some examples, a method for determining diameter measurements of an expandable medical device having a frame configured to maintain a constant height throughout expansion is provided. In some examples, the method comprises receiving one or more images showing the medical device during expansion thereof. In some examples, the method comprises measuring the height of the frame at multiple locations within the one or more images, the multiple locations comprising front and rear portions of the frame. In some examples, the method comprises calculating an average of the measured heights from the multiple locations. In some examples, the method comprises establishing a pixel-to-millimeter conversion factor by comparing the measured heights to a known physical height of the frame. In some examples, the method comprises determining a diameter of the medical device using the established pixel- to-millimeter conversion factor.Attorney Docket No: TH VVA- 13387 WO01

[0034] In some examples, a method for determining dimensions of a medical device within an image is provided, wherein the medical device has a plurality of markers disposed thereon defining at least one ellipse. In some examples, the method comprises receiving one or more images showing the medical device. In some examples, the method comprises determining a tilt angle of the medical device based on a ratio between minor and major ellipse diameters of the at least one ellipse. In some examples, the method comprises measuring one or more dimensions of the medical device. In some examples, the method comprises correcting the measured one or more dimensions based at least in part on the determined tilt angle.

[0035] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0036] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0037] Fig. 1 A shows a perspective view of an example prosthetic valve.

[0038] Fig. IB shows a front view of a frame of the prosthetic valve of Fig. 1A in a straight orientation.

[0039] Fig. 1C shows a first example delivery assembly comprising a delivery apparatus carrying a prosthetic valve.

[0040] Fig. ID shows an example setup for a patient undergoing implantation of a prosthetic valve.

[0041] Fig. 2A shows a front view of the frame of the prosthetic valve of Fig. 1A in a tilted orientation.Attorney Docket No: TH VVA- 13387 WO01

[0042] Fig. 2B shows a flow chart for a method of determining an expected expansion diameter of a prosthetic valve.

[0043] Fig. 2C shows an illustrative concept of determining an orientation angle of a prosthetic valve.

[0044] Fig. 2D shows an illustrative concept of a tilted coronary stent.

[0045] Fig. 2E shows a second example delivery assembly comprising a delivery apparatus carrying a prosthetic valve.

[0046] Fig. 2F shows a flow chart for a method of identifying an ovality in a prosthetic valve.

[0047] Fig. 3A shows a front view of the frame of the prosthetic valve of Fig. 1 A in a slightly tilted orientation.

[0048] Fig. 3B shows an illustrative concept of the difference in length within an image of identical structures.

[0049] Fig. 3C shows a flow chart for a method of determining height variance in a prosthetic valve.

[0050] Fig. 4A show a front view of a frame of a prosthetic valve.

[0051] Fig. 4B shows a conceptual diagram of arc angles of a frame.

[0052] Fig. 4C shows a conceptual diagram of a frame of a prosthetic valve.

[0053] Fig. 5A shows a frame of a prosthetic valve having an hour-glass shape.

[0054] Fig. 5B shows an implanted prosthetic valve with a docking device.

[0055] Fig. 5C shows a perspective view of the docking device of Fig. 5B.

[0056] Fig. 5D shows the frame of the prosthetic valve with the docking device.

[0057] Fig. 5E shows a conceptual diagram of an arc length.

[0058] Fig. 5F shows a conceptual diagram of the frame of Fig. 5A.

[0059] Fig. 6 shows a conceptual illustration of a portion of part of a method of determining a diameter of a prosthetic valve within an image.

[0060] Fig. 7 shows a diagram illustrating spatial orientation determination methods for prosthetic valve analysis.

[0061] Fig. 8 shows an illustrative concept of determining an orientation angle of a prosthetic valve of Fig. 7.

[0062] Figs. 9A-9C show various views of an exemplary prosthetic valve with nonforeshortening characteristics.

[0063] Figs. 10A-10B show side views of the frame of the prosthetic valve of Figs. 9A-9C in compressed and expanded states, respectively.Attorney Docket No: TH VVA- 13387 WO01

[0064] Figs. 11A-11B show perspective and flattened views of a frame with multiple intermediate rungs.

[0065] Fig. 12 shows an exemplary prosthetic valve with an information indicator on an outer skirt.

[0066] Figs. 13A-13B show side views of an exemplary prosthetic valve with apex regions, with and without soft components.

[0067] Figs. 14A-14B show side and detailed views of an exemplary prosthetic valve with a radiopaque information indicator attached to a commissure.

[0068] Figs. 15A-15B show side views of an exemplary prosthetic valve with information indicators formed as openings in axial frame members.

[0069] Figs. 16A-16B show side and detailed views of an exemplary prosthetic valve with a widened portion comprising an information indicator.

[0070] Figs. 17A-17B show side and detailed views of an exemplary prosthetic valve with externally formed information indicators.

[0071] Fig. 18 shows an externally formed information indicator in a non-commissural axial strut.

[0072] Fig. 19 shows a plurality of axial frame members each comprising an externally formed information indicator.

[0073] Figs. 20A-20B show side and detailed views of an exemplary prosthetic valve with commissure support members comprising information indicators.

[0074] Fig. 21 shows a fluoroscopic image of a delivery apparatus with an information indicator on a nosecone.

[0075] Figs. 22A-22D show various arrangements of information indicators on delivery apparatus components.

[0076] Fig. 23 shows a side view of an exemplary prosthetic valve with information indicators extending from junctions.DETAILED DESCRIPTION

[0077] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combinationAttorney Docket No: TH VVA- 13387 WO01 thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0078] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0079] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0080] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0081] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper"Attorney Docket No: TH VVA- 13387 WO01 part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0082] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0083] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (for example, the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terns "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0084] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.

[0085] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0086] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.Attorney Docket No: TH VVA- 13387 WO01

[0087] As used herein, terms such as "first", "second", and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0088] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property that differs from the listed value and / or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0089] The term "fine-tuning", as used herein, means a method where weights of a pre-trained model are trained on new data, as known to those skilled in the art. In some examples, as known to those skilled in the art, fine-tuning comprises inputting data into a neural-network based model and the model is prompted to fine-tune a predetermined sub-set of weights thereof based on a loss-function. In some examples, the output of the model is input into a second model which generates an input for the loss-function, as known to those skilled in the art. It is noted that this is merely one method of performing fine-tuning, and is not meant to be limiting in any way. The term "soft prompt", as used herein, means learnable tensors concatenated with the input embeddings.

[0090] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a", "b", "c", etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and / or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0091] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, someAttorney Docket No: TH VVA- 13387 WO01 components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0092] Figs. 1A and IB show various views of an exemplary prosthetic valve 100 with and without soft components attached thereto, respectively. Fig. 1C shows a perspective view of an exemplary delivery assembly 200. Fig. ID shows an example setup for a patient 252 on a patient support platform 250 undergoing implantation of prosthetic valve 100 (not shown in Fig. ID for simplicity).

[0093] As described, the below systems and methods are described in relation to a prosthetic valve, however this is not meant to be limiting in any way. In some examples, the below systems and methods can be implemented in relation to other medical devices, including stents and / or catheters.

[0094] The delivery assembly 200 can include the prosthetic valve 100 and a delivery apparatus 202. The prosthetic valve 100 can be on or releasably coupled to the delivery apparatus 202.

[0095] The term "prosthetic valve", as used herein, refers to any type of an expandable prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state.

[0096] It is understood that the prosthetic valves disclosed herein may be used with a variety of delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus. Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165 and U.S. Patent Application Publication No. 2023 / 0225863, published July 20, 2023, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and lockingAttorney Docket No: TH VVA- 13387 WO01 assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0097] A prosthetic valve 100 can be crimped or retained by a delivery apparatus 202 in a compressed state during delivery, and then expanded to the expanded state once the prosthetic valve 100 reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.

[0098] A prosthetic valve 100 of the current disclosure may include any balloon-expandable prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0099] A catheter deliverable prosthetic valve 100 can be delivered to the site of implantation via the delivery assembly carrying the valve 100 in a radially compressed or crimped state, toward the target site, to be mounted against the native anatomy, by expanding the prosthetic valve 100. Balloon expandable valves 100 generally involve a procedure of inflating a balloon 234 within a prosthetic valve 100, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is sufficiently expanded, the balloon 234 is deflated and retrieved along with the delivery apparatus 202. The delivery assembly 200 can be utilized, for example, to deliver a prosthetic aortic valve for mounting against the aortic annulus, to deliver a prosthetic mitral valve for mounting against the mitral annulus, or to deliver a prosthetic valve for mounting against any other native annulus.

[0100] Figs. 1A-1B show an example of a balloon expandable prosthetic valve 100, illustrated in an expanded state. The prosthetic valve 100 can comprise an outflow end 102, an inflow end 104, and a central longitudinal axis Ca extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the outflow end 102 is the proximal end of the prosthetic valve 100, and the inflow end 104 is the distal end of the prosthetic valve 100. Nevertheless, depending for example on the delivery approach of the valve, the outflow end can be the distal end of the prosthetic valve, and the inflow end can be the proximal end of the prosthetic valve.

[0101] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 100.

[0102] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.Attorney Docket No: TH VVA- 13387 WO01

[0103] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0104] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "distal to" and "proximal to", respectively. Thus, for example, a lowermost component can refer to a distal-most component, and an uppermost component can similarly refer to a proximal-most component.

[0105] The prosthetic valve 100 comprises a frame 106 movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly 120 mounted within the frame 106. The frame 106 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel- based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 106 can be crimped to a radially compressed state on a balloon catheter 210, and then expanded inside a patient 252 by an inflatable balloon 234.

[0106] In the example illustrated in Figs. 1A - IB, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 112. In the current disclosure, the term "strut" encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 112 may be any elongated member or portion of the frame 106. The frame 106 can include a plurality of strut rungs 110 that can collectively define one or more cell rows 148 of cells 132. The term "cell", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts, including, in some examples, struts that can have one or more undulations along their lengths.

[0107] The struts 112 in each rung 110 are arranged in strut pairs 111 of angled struts 108, wherein each pair 111 substantially forms a V shape. The angled struts 108 of each pair 111 intersect with each other at a vertex 156, which is illustrated in Figs. 1A-1B in the form of a generally U-shaped structure, though any other suitable shape of the vertex is contemplated. "Vertex" as used herein refers to the highest or most outward extending, in an axial direction, point.Attorney Docket No: TH VVA- 13387 WO01

[0108] The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0109] The end portions of the stmts 112 form apices 116 at the outflow end 102 and apices 118 at the inflow end 104. A height of the frame 106 is defined by the distance between the outflow apices 116 and the inflow apices 118, as indicated in Fig. 2A. The stmt pairs 111 can intersect at junctions 1 14 formed between the outflow apices 1 16 and the inflow apices 118. The junctions 114 can be equally or unequally spaced apart from each other, and / or from the apices 116, 118, between the outflow end 102 and the inflow end 104.

[0110] At least some of the stmts 112 can be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 106 can be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and the like.

[0111] A leaflet assembly 120 of the prosthetic valve 100 can include a plurality of leaflets 122 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 102. While three leaflets 122 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1 A, it will be clear that a prosthetic valve 100 can include any other number of leaflets 122.

[0112] The inflow or cusp edges (concealed from view in Fig. 1A) of the leaflets 122 can be secured to the frame 106 directly or indirectly, such as by being sutured directly to the frame, being sutured to an inner skirt, and / or via one or more connecting skirts. The cusp portions of the leaflets 122 can collectively define a scalloped line of attachment. Further examples and methods of attaching skirts and seal members to a frame, as well as method and techniques for coupling leaflets 122 to the frame 106, with or without connecting skirts, are disclosed in US Pat. No. 11,096,781, which is incorporated herein by reference.

[0113] Adjacent leaflets 122 can be arranged together to form commissures 130 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing an upper portion (e.g., above the scalloped line) of the leaflet assembly 120 to the frame 106. In some examples, each leaflet 122 can comprise opposing tabs 126. Each tab 126 can be secured to an adjacent tab 126 of an adjacent leaflet 122 to form a commissure 130 that is secured to the frame 106. The tabs 126 can be folded in various manners, for example to form radiallyAttorney Docket No: TH VVA- 13387 WO01 extending layers and circumferentially extending layers facing the frame. Radially extending layers can extends radially inward from a location on the frame 106 to free edges 128, also termed coaptation edges, of the leaflets.

[0114] During valve cycling, the leaflets 122 can articulate at the inner most edges of the tab layers, which helps space the leaflets away from the frame 106 during normal operation of the prosthetic valve. This is particular advantageous in cases where the prosthetic valve 100 is not fully expanded to its nominal size when implanted in a patient. As such, the prosthetic valve 100 can be implanted in a wider range of patient annulus sizes. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 122 can be coupled to the frame 106 of the prosthetic valve 100, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,56. all of which are incorporated herein by reference in their entireties.

[0115] In some examples, the prosthetic valve 100 can further comprise at least one skirt or sealing member. In some examples, an inner skirt 140 can be secured to an inner surface of the frame 106, configured to function, for example, as a sealing member to prevent or decrease peri valvular leakage. An inner skirt 140 can further function as a medium for connecting the leaflets 122 to the frame 106, and / or function to protect the leaflets 122 against damage which may be caused by contact with the frame 106, for example during valve crimping or during working cycles of the prosthetic valve 100. In some examples, the prosthetic valve 100 can comprise an outer skirt 170 mounted on the outer surface of the frame 106, configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 100.

[0116] Any of the inner skirt 140 and / or outer skirt 170 can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). In some examples, the inner skirt 140 can be formed of a single sheet of material that extends continuously around the inner surface of frame 106. In some examples, the outer skirt 170 can be formed of a single sheet of material that extends continuously around the outer surface of frame 106.

[0117] Various exemplary implementations for prosthetic valve 100 and / or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by allAttorney Docket No: TH VVA- 13387 WO01 specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0118] For example, a prosthetic valve 100a, illustrated in Figs. 1A-1C, is an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that the frame 106afurther comprises a plurality of axial frame members 150. The term "axial frame member" refers to a strut or a component of the frame that generally extends in an axial direction. Specifically, the axial frame members 150aof frame 106acomprise a plurality of proximal axial frame members 134, arranged circumferentially at outflow end 102, and axially extending between outflow junctions 1140 and the junctions 114S of the intermediate rung 110S adjacent to the outflow cell row 1480, as shown in Figs 1 A-1B. In some examples, some of the proximal axial frame members 134aof frame 106aare commissure support axial members 142. Commissure support axial members 142acan optionally comprise a commissure window 146, radially extending through the thickness of the commissure support axial member 142, between two axially- extending sidewalls 147. The commissure window 146 can be configured to accept tabs 126 therein so as to couple the leaflet assembly 120 to the frame 106a.

[0119] While commissure support axial members 142athat include commissure windows 146aare illustrated and described herein, it is to be understood that a frame 106acan include other types of commissure support members configured to mount a commissure 130 in any other suitable manner, such as by supporting portions of the leaflet assembly 120 that can be wrapped therearound, or can include apertures through which sutures for attaching the commissures can be passed, and the like.

[0120] In some examples, some of the proximal axial frame members 134aare non- commissural axial struts 117, meaning they are not configured to be attached to any of the commissures 130. The axial frame members of prosthetic valve 100afurther comprise a plurality of distal axial frame members 135, arranged circumferentially at inflow end 104, and axially extending between inflow junctions 1141 and the junctions 114S of the intermediate rung 110S adjacent to the inflow cell row 1481. In some examples, distal axial frame members 135 are non-commissural axial struts 117a. The axial length of the distal axial frame members 135 can be either longer or shorter than that of the proximal axial frame members 134a.

[0121] The height of frame 106ais defined in part by the axial frame members 150aand in part by the rungs of angled struts 108, which are configured to be pivotable or bendable relative toAttorney Docket No: TH VVA- 13387 WO01 each other, so as to permit frame expansion or compression. As the frame 106aexpands, the angled struts 108 bend such that the angle between circumferentially adjacent angled struts 108 increases. Accordingly, during expansion, frame 106aexperiences foreshortening.

[0122] Fig. 1C illustrates a delivery assembly 200 that includes a delivery apparatus 202 adapted to deliver a prosthetic device, which can be the prosthetic valve 100 described above with respect to Figs. 1A-1B. The delivery apparatus 202 includes a handle 204 and a balloon catheter 210 having an inflatable balloon 234 mounted on its distal end. A balloon expandable prosthetic device, such as balloon expandable prosthetic valve 100, can be carried in a crimped state over the balloon catheter 210.

[0123] In some examples, a delivery apparatus 202 further comprises an outer delivery shaft 208. Optionally, an outer delivery shaft 208 of a delivery apparatus 202 can concentrically extend over the balloon catheter 210.

[0124] The outer delivery shaft 208 and the balloon catheter 210 can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer delivery shaft 208 relative to the balloon catheter 210, or a distally oriented movement of the balloon catheter 210 relative to the outer delivery shaft 208, can expose the prosthetic valve 100 from the outer delivery shaft 208.

[0125] A delivery apparatus 202 can further include a nosecone 224 to facilitate advancement of the delivery apparatus 202 through the vascular of patient 252 to the site of treatment. A nosecone shaft 218 can extend proximally from the nosecone 224 through a lumen of the balloon catheter 210. The nosecone 224 can be conical or frustoconical in shape. Attachment of the nosecone shaft 218 to the nosecone 224 can be achieved by a variety of methods, such as overmolding, radio-frequency welding, through an adhesive, and / or a combination thereof. In some examples (not illustrated), the nosecone shaft 218 can extend through the entire length of the nosecone 224, such that a distal end of the nosecone shaft 218 is aligned with a distal end of the nosecone 224. In some examples (not illustrated), the nosecone shaft 218 is coupled to one or more components, such as collars or other connectors, which are in turn attached to the nosecone 224.

[0126] In Fig. 1C, a prosthetic valve 100 is mounted on the balloon 234 and is shown in a crimped state, providing prosthetic valve 100 with a reduced diameter for delivery to the heart via the patient’s vasculature.

[0127] Although the example illustrated in Fig. 1C shows a prosthetic device (e.g., prosthetic valve 100) as being crimped or mounted on the balloon 234 for delivery to the treatment location, it should be understood that the prosthetic device can be crimped or mounted at aAttorney Docket No: TH VVA- 13387 WO01 location different from the location of balloon 234 (e.g., proximal to the balloon 234) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic device. This off-balloon delivery allows the prosthetic device to be crimped to a lower profile than would be possible if the prosthetic device was crimped on top of the balloon 234. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic device) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic device can be particularly helpful when navigating through portions of the patient’s vasculature which are particularly narrow, such as the iliac artery.

[0128] The proximal ends of the balloon catheter 210, the outer delivery shaft 208, and / or the nosecone shaft 218, can be coupled to the handle 204. During delivery, the handle 204 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 202, such as the nosecone shaft 218, the outer delivery shaft 208, and / or the balloon catheter 210, through the patient’s vasculature and / or along the target site of implantation, as well as to inflate the balloon 234 mounted on the balloon catheter 210, for example to expand a prosthetic valve 100 mounted on the balloon 234, and to deflate the balloon 234 and retract the delivery apparatus 202, for example once the prosthetic valve 100 is mounted in the implantation site.

[0129] The handle 204 can include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 202. In the illustrated example, the handle 204 includes a first adjustment member, such as the illustrated rotatable knob 206a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can extend distally from the handle 204 through the outer delivery shaft 208 and has a distal end portion affixed to the outer delivery shaft 208 at or near the distal end of the outer delivery shaft 208. Rotating the knob 206a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 202. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.

[0130] In some examples, the handle 204 can include a second adjustment member such as the illustrated rotatable knob 206b, configured to adjust the axial position of the balloon catheter 210 relative to the outer delivery shaft 208, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 202. Further details on the delivery apparatus 202 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.Attorney Docket No: TH VVA- 13387 WO01

[0131] A prosthetic valve 100 can be carried by the delivery apparatus 202 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures).

[0132] The balloon 234 can be secured to balloon catheter 210 at the balloon’s proximal end, and to either the balloon catheter 210, the nosecone shaft 218, or the nosecone 224, at its distal end. In some examples, the balloon 234 is secured to a distal end portion of the balloon catheter 210 at its proximal end, while the balloon’s distal end can be coupled, directly or indirectly, to another component of the delivery apparatus 202, such as the nosecone 224 or nosecone shaft 218.

[0133] In some examples, the balloon 234 is coupled to a proximal end portion 228 of the nosecone 224. The proximal end portion 228 can optionally include an outer step configured to accommodate the distal end of the balloon 234, such that the outer surface of the balloon 234 can be flush or otherwise relatively continuous with the outer surface of the nosecone 224. Similarly, in some examples, the distal end portion of the balloon catheter 210 can include an outer step configured to accommodate the proximal end of the balloon 234, such that the outer surface of the balloon 234 can be flush or otherwise relatively continuous with the outer surface of the balloon catheter 210.

[0134] In some examples, such as when the balloon 234 is attached at both ends thereof to the nosecone 224 and balloon catheter 210, both the nosecone 224 with nosecone shaft 218 and the balloon catheter 210 can be configured to move simultaneously in the axial direction, without necessarily being axially movable relative to each other, or while axial movement of one relative to the other is limited. In such examples, the delivery apparatus 202 can be designed such that axial movement of the balloon catheter 210 causes the nosecone shaft 218 to move therewith, or such that axial movement of the nosecone shaft 218 causes the balloon catheter 210 to move therewith.

[0135] During implantation of prosthetic valve 100, balloon 234 is configured to transition between a deflated state and an inflated state. The inflation of balloon 234 causes prosthetic valve 100 to transition from a crimped state, as shown in Fig. 1C, and an expanded state, as shown in Figs. 1A - IB. When reaching the site of implantation, the deflated balloon 234, carrying crimped prosthetic valve 100 thereover, can be advanced to the target site to expand the prosthetic valve. Once the prosthetic valve 100 is expanded to its functional diameter within a native annulus or within a previously implanted prosthetic valve, the balloon 234 can be deflated, and the delivery apparatus 202 can be retrieved from the body of patient 252.Attorney Docket No: TH VYA- 13387 WO01

[0136] In some examples, as further shown in Fig. 1C, the balloon catheter 210 can distally extend from a balloon catheter hub 220 which can be disposed proximally to the handle 204. In some examples, the balloon catheter hub 220 includes a first port 222a configured to receive fluid from a fluid source comprising inflation fluid and a second port 222b configured to receive a guidewire (not shown). The term “inflation fluid,” as used herein, means a fluid (e.g., saline, though other liquids or gas can be used) used for inflating the balloon 234. The inflation fluid source (not shown) is in fluid communication with balloon 234 via balloon catheter 210 such that fluid from the fluid source can flow through the balloon catheter 210 into balloon 234 to inflate it.

[0137] Nosecone shaft 218, balloon catheter 210, and outer delivery shaft 208, can be formed from, or include, any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®). In some examples, balloon catheter 210 and / or outer delivery shaft 208 have longitudinal sections formed from, or including, different materials, in order to vary the flexibility of the shafts along their lengths. In some examples, nosecone shaft 218 has an inner liner or layer formed of Teflon® to minimize sliding friction with a guidewire. Balloon may be made of one polymer, or use several layers or a mix of different polymers. Polymers such as Nylon, PEBAX, PET, parylene and / or polyurethane may be used to make the wall of balloon 234.

[0138] In some examples, any delivery assembly of the current disclosure can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the delivery assembly can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0139] As shown in Fig. ID, patient 252 is imaged by an imager 260. In some examples, imager 260 is supported by a C-arm 262 configured to rotate imager 260 about one or more respective rotation axes. In some examples, imager 260 is a fluoroscopy imager. In some examples, imager 260 is an x-ray imager. In some examples, imager 260 is a CT imager. In some examples, imager 260 is an echocardiograph ultrasound transceiver. In some examples, imager 260 and / or C-arm 262 are controlled by a control unit 264. In some examples, control unit 264 is connected to a user output terminal 266, such as a display. In some examples, control unitAttorney Docket No: TH VVA- 13387 WO01264 is connected to a user input terminal 268, such as a keyboard or a touch screen. In some examples, control unit 264 comprises one or more processors 265 and a memory 267, the memory 267 having stored therein a plurality of instructions that when read by the one or more processors 265 cause the one or more processors 265 to perform various steps, as will be described below. Although control unit 264 is illustrated as a stationary work station, this is not meant to be limiting in any way, and one or more functions of control unit 264 can be implemented on any suitable device, such as a smartphone.

[0140] When implanting a prosthetic device, such as balloon expandable prosthetic valve 100, it is desirable to expand the valve to a maximum size allowed by the patient’s anatomical considerations, in order to avoid paravalvular leakage or other unfavorable hemodynamic phenomena across the valve that may be associated with a mismatch between the valve’s expansion diameter and the surrounding tissue, while mitigating the risk of annular rupture that may result from over-expansion.

[0141] In some examples, a diameter of prosthetic valve 100 is determined based on images taken by imager 260. It is noted that the term "determined", as used herein, is not meant to be limiting to an exact determination, and an approximation within acceptable predetermined parameters can be considered as a determination, without exceeding the scope of the disclosure.

[0142] As will be described below, one or more images showing the expansion of prosthetic valve 100 can be received from imager 260. In some examples, the images are received directly from imager 260. In some examples, the images are taken by a camera pointed at a display showing the images provided by imager 260.

[0143] It is noted that prosthetic valve 100 can be tilted in any orientation within the image, and Fig. 2A shows frame 106aof prosthetic valve 100ain such a tilted orientation. It is noted that the illustrated orientation of frame 106ais relative to the plane of the page, which represents the plane of the image. In some examples, the orientation is taken into account when determining the diameter, as will be described below.

[0144] Fig. 2B shows a flowchart for a method of determining an expected expansion diameter of prosthetic valve 100. The term "expansion diameter", as used herein, means an expected diameter of prosthetic valve 100 if prosthetic valve would recoil at the imaging time of the image. Particularly, as described above, once prosthetic valve 100 is sufficiently expanded, balloon 234 is deflated, thereby ceasing the expansion of frame 106 of prosthetic valve 100. However, following deflation of balloon 234, there is typically a recoil of prosthetic valve 100 such that the diameter thereof shrinks slightly. Thus, the expansion diameter is the expected diameter should the recoil occur at the moment the image was taken.Attorney Docket No: TH VYA- 13387 WO01

[0145] One issue in measuring a diameter of an object within a 2-dimensional image, such as a fluoroscopy image, is that the size of the pixels in relation to the actual size of the objects in the image are unknown. As will be described below, this can be solved by measuring the ratio of the height to the diameter of prosthetic valve 100. Each type of prosthetic valve 100 has known correlations between the heigh-diameter ratio and the actual diameter size, thus the diameter can be determined based on the height-diameter ratio.

[0146] In step 1000, one or more images are received at control unit 264, the images each showing prosthetic valve 100 being expanded. In some examples, prosthetic valve is expanded by a balloon 234, however this is not meant to be limiting in any way. In some examples, prosthetic valve 100 comprises a mechanically expandable prosthetic valve. In some examples, as described above, the images are a series of fluoroscopic images taken at predetermined intervals. In some examples, the series of fluoroscopic images form a fluoroscopic video.

[0147] In step 1010, one or more features of prosthetic valve 100 are identified within the image. In some examples, control unit 264 first defines a region of interest within the image, the region of interest (ROI) containing prosthetic valve 100. In some examples, the ROI is defined using one or more object detection algorithms. In some examples, the ROI is defined using a convolutional neural network (CNN) trained to detect objects, such as a YOLO model.

[0148] In some examples, control unit 264 then identifies apices 116 and 118 of frame 106 within the defined ROI. Although the above has been described as a two-step process where an ROI is defined and then apices are identified, this is not meant to be limiting in any way, and the apices can be identified without first defining an ROI. In some examples, the apices 116 and 118 are identified using one or more respective detective algorithms. In some examples, the apices 116 and 118 are identified using a CNN trained to detect edges and / or apices, such as U-Net.

[0149] In step 1020, control unit 264 measures a distance, in pixels, between opposing apices 116 and / or between opposing apices 118 to thereby determine the diameter D of prosthetic valve 100 at inflow end 104 and / or at outflow end 102. In some examples, control unit 264 further identifies edges of frame 106 and measures a distance, in pixels, between the opposing edges at various heights, thereby determining the diameter of prosthetic valve 100 at 2, 3 or even more heights. In some examples, control unit 264 determines an average of the plurality of measured diameters. In some examples, control unit 264 utilizes apices 116 to define an ellipse, and the measured diameter D at outflow end 102 is defined as the long diameter of the ellipse. In some examples, control unit 264 utilizes apices 118 to define an ellipse, and the measured diameter D at inflow end 104 is defined as the long diameter of the ellipse.Attorney Docket No: TH VVA- 13387 WO01

[0150] Control unit 264 further measures the distance, in pixels, between outflow end 102 and inflow end 104 of prosthetic valve 100 to thereby determine the height of prosthetic valve 100. In some examples, the height of prosthetic valve 100 is measured by determining a distance between one or more apices 116 and one or more apices 118. In some examples, control unit 264 measures the height of prosthetic valve 100 at a plurality of locations on frame 106. In some examples, control unit 264 measures the height of prosthetic valve 100 at 4 locations. In some examples, the 4 locations include: the front of frame 106; the rear of frame 106: the right side of frame 106; and the left side of frame 106. In some examples, control unit 264 further determines an average of the plurality of measured heights.

[0151] It is noted that the above has been described in relation to examples where distances are measured between apices of frame 106, however this is not meant to be limiting in any way, and any points on prosthetic valve 100 can be used for measuring heights and diameters of prosthetic valve 100, without exceeding the scope of the disclosure.

[0152] As described above, prosthetic valve 100 may be at a tilted orientation within the image. Therefore, the measured height is not the actual height H, but only a projection of the height. In some examples, control unit 264 compensates for the tilt angle 6. As illustrated in Fig. 2C, the measured height is in fact HcosO. It is noted that the illustration of Fig. 2C is shown in a side view, as opposed to the view in Fig. 2A, such that the plane of the image is orthogonal to the page in Fig. 2C, with the imager being to the left of the illustration (not shown).

[0153] In some examples, as illustrated in Fig. 2C, control unit 264 further measures the height between the rear apices 116 and the front apices 1 16, this height is DsinO. As described above, D is the diameter of prosthetic valve 100 and H is the height of prosthetic valve 100. Since control unit 264 has already measured D, sinO can be found by dividing the measured height DsinO with diameter D, and 0 can then be derived. Once 0 is determined, cosO can be determined, and H can be determined by dividing the measured height HcosO with cosO.

[0154] As described above, H and D have been measured, however they have been measured in pixels, not in millimeters, since the pixel size is typically unknown. In some examples, control unit 264 determines the ratio of H / D, and the ratio H / D is compared to known ratio values. In some examples, the ratio H / D is compared to a curve representing known ratio values for prosthetic valve 100, the curve indicating the diameter of prosthetic valve 100 giving the specific H / D ratio. Utilizing a curved graph can aid the physician at seeing how quickly the valve is expanding. In some examples, the ratio H / D is compared to a stored group of known ratio values for prosthetic valve 100, corresponding to diameter values, such as in a look up table (LUT). It is noted that the ratio H / D can change as prosthetic valve 100 expands. Thus,Attorney Docket No: TH VVA- 13387 WO01 the value corresponding to the determined ratio H / D gives the diameter of prosthetic valve 100 for that amount of expansion. In some examples, user output terminal 266 can show the image itself, a zoom-in of a portion of the image containing prosthetic valve 100, and the abovedescribed numbers and / or graph. In some examples, these can be displayed on a split screen or on several different screens.

[0155] Although the above has been described in relation to prosthetic heart valves, this is not meant to be limiting in any way. As described above, the above algorithms can be relevant as well for stents, such as coronary stents.

[0156] In relation to prosthetic valves, coronary stents generally exhibit a smaller diameter and longer length. For example, coronary stents can be generally classified into 3 groups: short stents, being 8 - 12 mm in length; medium-length stents, being 14 - 24 mm in length; and long stents, being 28 - 38 mm in length. A greater length can mean that calculations of the actual diameter based on the ratio H / D could be more accurate.

[0157] A conceptual diagram of a coronary stent 180 is shown in Fig. 2D, advancing through a coronary artery 190, which generally follows a curved path over the heart wall, thereby causing the coronary stent 180 to assume such a curvature as well. The coronary stent 180 extends from an inflow end 181 to an outflow end 182, and Fig. 2D shows the coronary stent 180 in two different positions along the coronary artery 190. As shown, in one position along the coronary artery 190, the longitudinal axis of the coronary stent 180 can be within the image plane, and therefore the inflow end 181 and outflow end 182 are seen as generally straight lines. However, in another position along the coronary artery 190, the longitudinal axis of the coronary stent 180 can be tilted out of the image plane, and therefore the inflow end 181 and outflow end 182 are seen as ellipses, each having a long axis denoted d and a short axis denoted d'.

[0158] As described above, in some examples a method for adjusting diameter calculations in accordance with a tilt angle can be provided. In some examples, coronary stent 180 comprises a plurality of markers 183. In some examples, the markers 183 are at least partially radiopaque. In some examples, a plurality of sets of markers 183 are positioned on the coronary stent 180, each set of markers 183 arranged along the circumference of the coronary stent 180, and the plurality of sets being laterally spaced from each other. In some examples, each marker 183 in a first set is generally equally spaced from a respective marker 183 in a second set. In Fig. 2D, a first set of markers 183 is shown at inflow end 181 and second set of markers 183 is shown at outflow end 182, however this is not meant to be limiting in any way, and the sets of markers 183 can be placed anywhere along the coronary stent 180. Fig. 2D is shown in an exampleAttorney Docket No: TH VVA- 13387 WO01 where each set comprises 4 markers 183, however this is not meant to be limiting in any way, and any number of markers 183 can be provided.

[0159] In some examples, control unit 264 can comprise a stent measurement module stored in memory 267 and executed by processors 265, and in some examples the stent measurement module of control unit 264 is configured to measure dimensions of the coronary stent 180 using images from imager 260, as described below.

[0160] In some examples, control unit 264 determines the lengths of the long axis d and the short axis d'. In some examples, control unit 264 determines the tilt angle 0 based at least in part on lengths d and d'. In some examples, control unit 264 further determines the distance between the sets of markers 183, denoted A. In some examples, control unit 264 determines tilt angle 0 using a trigonometric relationship. In some examples, tilt angle 0 is determined by the equation sin(0) = minor ellipse diameter d’ / major ellipse diameter d. Control unit 264 can then determine length A as the measured length divided by the cosine of 0.

[0161] In some examples, after correcting for the tilt angle, the diameter of the coronary stent 180 can then be determined. In some examples, as described above, the diameter in millimeters can be determined based at least in part on a known relationship between the height and the diameter.

[0162] In some examples, control unit 264 measures the length, in pixels, of the length of the coronary stent 180, or a section thereof. In some examples, the section is the maximally visualized section of the coronary stent 180. Since the length of the coronary stent 180, or the section thereof, is known in millimeters, since there is little foreshortening, the length thereof can be used to measure the size of pixels, such as by dividing the known length in millimeters with the measured length in pixels. In some examples, control unit determines the diameter of the coronary stent 180 by multiplying the measured diameter in pixels by the known length of the stent, or stent section, in millimeters, and dividing by the measured length in pixels.

[0163] In some examples, where a plurality of sets of markers 183 are provided, the length of the coronary stent 180 is determined as the summation of the distances between the marker sets.

[0164] In some examples, for each set of markers 183, a second set of markers 183 is placed adjacent thereto, at a predetermined distance. For example, if markers 1 3 are placed at each of the inflow end 181 and the outflow end 182, then two sets of adjacent markers are placed at the inflow end 181 and two sets of adjacent markers are placed at the outflow end 182. The adjacent sets of placed at a predetermined distance from each other, such as 1 - 3 mm. In some examples, control unit 264 determines the minor ellipse diameter d’, which can be small, byAttorney Docket No: TH VVA- 13387 WO01 measuring the distance between adjacent markers 183 and subtracting the known distance therebetween. In some examples, this can allow the use of smaller markers 183, which can reduce the risk of glaring.

[0165] In some examples, an ovality of the coronary stent 180 can be determined, as will be described below in relation to prosthetic valve 100.

[0166] Although the above methods have been described in relation to a coronary stent 180, this is not meant to be limiting in any way, and the above method can be implemented in any type of stent, prosthetic valve or catheter.

[0167] In some examples, control unit 264 outputs the tilt angle 0 on user output terminal 266. In some examples, control unit 264 compares the tilt angle 0 to a predetermined range of acceptable angles. In the event that the tilt angle 0 is not within the predetermined range of acceptable angles, control unit 264 outputs an indication to adjust the angle of the coronary stent 180 and / or adjust the angle of imager 260. In some examples, the respective indication is output at user output terminal 266. In some examples, in the event that the tilt angle 0 is not within the predetermined range of acceptable angles, control unit 264 rotates imager 260 around a respective axis such that the tilt angle 0 enters the predetermined range of acceptable angles.

[0168] In some examples, control unit 264 determines a rate at which the diameter is increasing. In some examples, control unit 264 outputs the determined rate, optionally to be displayed on user output terminal 266. In some examples, control unit 264 further compares the determined rate to a predetermined threshold, and in some examples, controls the inflation of balloon 234 (as described below) to be within a predetermined range of the threshold.

[0169] It is further noted that each type of prosthetic valve 100 may have different diameter values corresponding to different ratio values. In some examples, the valve type is entered at user input terminal 268, and the respective curve and / or data set is selected based at least in part on the entered valve type.

[0170] It is noted that the above has been described in relation to examples where a 2D image is provided, without knowledge of the pixel size, however this is not meant to be limiting in any way. In some examples, a 3D image is provided where the pixel / voxel sizes are known. Alternatively, a 2D image is provided, but the pixel sizes are known. In such examples, it may be sufficient to measure the diameter / s D of prosthetic valve 100.

[0171] Thus, an image diameter of prosthetic valve 100 has been determined by control unit 264. The term "image diameter", as used herein, means the diameter of prosthetic valve 100 as it is in the image, i.e. the diameter of prosthetic valve 100 at an imaging time when theAttorney Docket No: TH VVA- 13387 WO01 respective image was taken. As described above, the image diameter may be an average of a plurality of diameters.

[0172] In step 1030, based at least in part on the determined image diameter of prosthetic valve 100, and based at least in part on one or more recoil values, an expected expansion diameter of prosthetic valve 100 is determined. As described above, the expected expansion diameter reflects the expected diameter of the prosthetic valve if the prosthetic valve would recoil at the imaging time. In some examples, the one or more recoil values comprises an average recoil value for the valve type of prosthetic valve 100. In some examples, the one or more recoil values comprises a range of previously measured differences between a prosthetic valve diameter before recoil and after recoil. In some examples, the expected expansion diameter is determined by subtracting the recoil vale from the determined image diameter.

[0173] Although the above has been described in relation to examples where the expected expansion diameter is determined based on an image diameter, this is not meant to be limiting in any way. In some examples, any sensor system can be used to measure the diameter of prosthetic valve 100, including ultrasound sensors, pressure-based sensors, infra-red based sensors and mechanical based sensors. In some examples, control unit 264 adjusts the measured diameter utilizing the one or more recoil values in order to determine the expected expansion diameter of prosthetic valve 100.

[0174] In some examples, during the implantation of the prosthetic valve 100, control unit 264 receives one or more sets of signals associated with the prosthetic valve 100. In some examples, the one or more sets of signals comprises diameter measurements of prosthetic valve 100, as described above.

[0175] In some examples, for each of the received one or more sets of signals, control unit 264 determines a signal diameter of the prosthetic valve. In some examples, the signal diameter is the diameter of the prosthetic valve at a sampling time when the set of signals was generated. The sampling time can be the imaging time, i.e., the time at which an image was taken, or a time where the diameter was measured utilizing one or more sensors.

[0176] In some examples, based at least in part on the determined signal diameter of the prosthetic valve 100 and one or more recoil values, control unit 264 determines the expected expansion diameter of the prosthetic valve. As described above, the expected expansion diameter reflects the expected diameter of the prosthetic valve if the prosthetic valve would recoil at the sampling time.

[0177] In some examples, control unit 264 displays the determined expected expansion diameter on user output terminal 266. In some examples, where a series of images are received,Attorney Docket No: TH VVA- 13387 WO01 the displayed expected expansion diameter is updated upon receiving each image. In some examples, the expected expansion diameter can be displayed in any suitable way, such as by displaying the values as a graph curve, displaying the numerical values on screen, or other suitable methods. In some examples, control unit 264 divides the determined expected expansion diameter by a preselected expansion diameter, and presents the result as a percentage and / or a fraction, thereby notifying the physician how close they are to the selected diameter.

[0178] The above has been described in examples where the expected expansion diameter is displayed, however this is not meant to be limiting in any way. In some examples, control unit 264 calculates the area and / or circumference that correlates with the expected expansion diameter. In some examples, control unit 264 displays any of the diameter, area or circumference.

[0179] In some examples, control unit 264 is further configured to control the inflation of balloon 234. As shown in Fig. 2E, in some examples, a delivery assembly 300 for prosthetic valve 100 is provided. Delivery assembly 300 is in all respects similar to delivery assembly 200 described above, with the exception that delivery assembly 300 comprises an inflation fluid system 310. In some examples, inflation fluid system 310 comprises: a reservoir 320 containing a predetermined volume of inflation fluid 322; a fluid flow channel 330; a pump 340; an optional flow meter 360; and an optional pressure sensor 370. In some examples, pump 340 is controlled by control unit 264 (not shown in Fig. 2E).

[0180] Fluid flow channel 330 is in fluid communication with balloon catheter 210. In some examples, fluid flow channel 330 is coupled to balloon catheter 210 via port 222a. In some examples, inflation fluid 322 comprises saline and / or sterile water, without limitation. The term "fluid communication", as used herein, means that fluid can flow between components in fluid communication with each other. The fluid communication can be accomplished via a direct connection between openings of the respective components or via additional components connected therebetween.

[0181] In some examples, pump 340 is in fluid communication with both reservoir 320 and fluid flow channel 330. In some examples, flow meter 360 is coupled between pump 340 and reservoir 320. Although pressure sensor 370 is illustrated as being near pump 340, this is not meant to be limiting in any way, and pressure sensor 370 can be positioned anywhere along the fluid path, including within balloon 234.

[0182] In operation, pump 340 pumps inflation fluid 322 through balloon catheter 210 into balloon 234, thereby inflating balloon 234 and expanding prosthetic valve 100. In some examples, control unit 264 controls pump 340 to initiate the pumping. In some examples,Attorney Docket No: TH VVA- 13387 WO01 control unit 264 controls pump 340 to adjust the flow of inflation fluid 322. In some examples, adjustment of the flow of inflation fluid 322 includes adjustment of the flow rate and / or the amount of inflation fluid 322 that flows into balloon 234. In some examples, the flow adjustment is responsive to: a user input, such as an input indicating the amount of inflation fluid 322 to be injected into balloon 234; flow meter 360 and / or pressure sensor 370, such that the flow of inflation fluid 322 remains within predetermined parameters. In some examples, control unit 264 can control pump 340 to reverse the flow of inflation fluid 322, thereby removing some, or all, of inflation fluid 322 from balloon 234.

[0183] In some examples, when the determined expected diameter reaches a predetermined value, control unit 264 controls pump 340 to cease pumping of inflation fluid 322 into balloon 234, thereby ending the expansion of prosthetic valve 100. In some examples, using control unit 264 to control pump 340 based on the determined expected diameter removes the need for limiting the volume of inflation fluid 322 within reservoir 320 since there may not be a danger of too much expansion.

[0184] In some examples (not shown), where rapid pacing is performed on the patient during delivery of prosthetic valve 100, control unit 264 can output a respective signal which can control the rapid pacing such that once the determined expected diameter reaches the predetermined value, rapid pacing can be stopped and blood flow can resume. In some examples, control unit 264 stops the rapid pacing after a predetermined time has passed from when the predetermined value has been reached for the expected diameter. In some examples, control unit 264 stops the rapid pacing after determining that the measured diameter has dropped, i.e., that recoil has occurred.

[0185] Although the above is described in relation to a balloon-expandable prosthetic valve 100, this is not meant to be limiting in any way. In some examples, where prosthetic valve 100 is a mechanically expandable valve or a self-expandable valve, control unit 264 controls a respective actuator that causes the mechanically expandable valve, or self-expandable valve, to cease, or continue, expansion thereof.

[0186] In some examples, the determined diameter, or diameters, of prosthetic valve 100 can be utilized for identifying and / or measuring ovalities in prosthetic valve 100. An ovality is when prosthetic valve 100 does not expand evenly, thereby not exhibiting a fully cylindrical shape. In some examples, when prosthetic valve 100 is fully expanded, determined by control unit 264 and / or based on a respective user input, control unit 264 determines an ovality of prosthetic valve 100.Attorney Docket No: TH VVA- 13387 WO01

[0187] In some examples, control unit 264 controls C-arm 262 to rotate by one or more rotation angles and controls imager 260 to take an additional image at each of those rotation angles. In some examples, C-arm 262 is rotated by a clinician. Control unit 264 then determines the diameter of prosthetic valve 100, either after deflation of balloon 234 or before deflation thereof. In some examples, control unit 264 compares the determined diameters to each other, and if the diameters are not equal, control unit 264 determines that there is an ovality present in prosthetic valve 100. In some examples, control unit 264 further outputs an indication that an ovality is present. In some examples, control unit 264 determines for each angle the difference in the diameter from an average of the diameters, and outputs an indication of the amount of ovality at each angle, the amount of ovality being a predetermined function of the difference between the determined diameter and the diameter average.

[0188] In some examples, the overall ovality is determined based on the different images, at different orientations. In some examples, control unit 264 determines the diameter at each orientation and the ovality O is determined as:O = (Dmax - Dmin) / D max EQ. 1 where Dmax is the largest determined diameter from all the orientations and Dmin is the smallest determined diameter from all the orientations. In some examples, control unit 264 determines the ovality of frame 106 at one or more predetermined heights of frame 106. In some examples, an ovality at a particular height is determined by determining, for each orientation, the diameter of frame 106 at that particular height, as described above. In some examples, the ovality is determined for both inflow end 104 and outflow end 102 of frame 106. In some examples, control unit 264 determines at which heights there is an ovality greater than a predetermined respective threshold and outputs an indication of these heights. In some examples, control unit 264 displays on user output terminal 266 the height, or heights, at which an ovality is present, and in some examples further displays the determined ovality at each height.

[0189] Fig. 2F shows a flow chart of a method of determining ovality in a prosthetic valve based on pre-recoil diameters of the prosthetic valve and post-recoil diameters of the prosthetic valve. In step 1200, an expansion image is received, the expansion image showing a prosthetic valve 100 being expanded, as described above. In some examples, the expansion image of step 1200 is the expansion image from which it was determined, either by control unit 264 or a user input, that the desired expansion diameter was reached.

[0190] In step 1210, following deflation of balloon 234, and the subsequent recoil of frame 106 of prosthetic valve 100, an implant image is received, the implant image showing the implanted prosthetic valve 100 after recoil. In step 1220, one or more features of prostheticAttorney Docket No: TH VVA- 13387 WO01 valve are identified in each of the expansion image of step 1200 and the implant image of step 1210, as described above in relation to step 1010 of Fig. 2B.

[0191] As further described above in relation to step 1020 of Fig. 2B, in step 1230 control unit 264 determines: a pre-recoil diameter of prosthetic valve 100 from the expansion image, the pre-recoil diameter being the diameter of the prosthetic valve at an imaging time when the expansion image was taken; and a post-recoil diameter of prosthetic valve 100 from the implant image, the post-recoil diameter being the diameter of the prosthetic valve at an imaging time when the implant image was taken. As described above, for each image a plurality of pre-recoil and post-recoil diameters, respectively, can be determined. In some examples, as described above in relation to step 1020, the diameters are determined in units of pixels. In some examples, as described above in relation to step 1020, the diameters are determined in units of millimeters.

[0192] In step 1240, based at least in part on the determined pre-recoil diameter and post-recoil diameter, control unit 264 identifies an ovality in prosthetic valve 100 and / or measures the ovality thereof. In some examples, the ovality identification and / or measurement is based on the difference between the pre-recoil diameter and the post-recoil diameter. In some examples, the difference is defined as the ratio therebetween. In some examples, control unit 264 compares the pre-recoil diameter to the post-recoil diameter. In some examples, in the event that the difference between the pre -recoil diameter and the post-recoil diameter is greater than a predetermined threshold, control unit 264 determines that an ovality is present. In some examples, the predetermined threshold is a known average recoil for the corresponding type of prosthetic valve 100, assuming a cylindrical (e.g., non-oval) expanded profile.

[0193] In some examples, a degree, or measurement, of the ovality comprises applying a predetermined function to the determined difference. In some examples, the degree, or measurement, of ovality is determined by comparing the determined difference to a set of predetermined values, such as in an LUT. In some examples, the set of predetermined values comprises a set of predetermined ranges. Particularly, as described above, if an ovality is present, the diameter will be different at different angles. Thus, the determined diameter from the present angle will provide a value that will be within in a range of diameters suitable for a particular ovality degree. Thus, the determined difference can be correlated to a predetermined range of ovality degrees.

[0194] In some examples, where a plurality of pre-recoil diameters and a plurality of postrecoil diameters are determined at different heights of prosthetic valve 100, control unit 264 identifies and / or measures the ovality at each of the different heights.Attorney Docket No: TH VVA- 13387 WO01

[0195] In some examples, control unit 264 displays an indication of the presence of an ovality and / or displays the determined degree of ovality.

[0196] In some examples, if an ovality is identified, control unit 264 controls pump 340 to reinflate balloon 324. In the event that the ovality is caused by a calcification, the reinflation of balloon 324 may dislodge the calcification.

[0197] Although the above has been described in relation to examples where the ovality is determined based on images, this is not meant to be limiting in any way. In some examples, as described above, any sensor system can be used to measure the diameter of prosthetic valve 100, including ultrasound sensors, pressure -based sensors, infra-red based sensors and mechanical based sensors. In some examples, control unit 264 measures the diameter before recoil of prosthetic valve 100 and after recoil of prosthetic valve 100 and determines the ovality thereof based on the measured diameters.

[0198] In some examples, during the implantation of prosthetic valve 100, control unit 264 receives a first set of signals associated with prosthetic valve 100. In some examples, after implantation of the prosthetic valve, prosthetic valve 100 receives a second set of signals associated with prosthetic valve 100.

[0199] In some examples, based at least in part on the received first set of signals, control unit 264 determines a pre-recoil diameter of prosthetic valve 100, the pre-recoil diameter being the diameter of prosthetic valve 100 at a first sampling time when the first set of signals was generated.

[0200] In some examples, based at least in part on the received second set of signals, control unit 264 determines a post-recoil diameter of prosthetic valve 100, the post-recoil diameter being the diameter of prosthetic valve 100 at a second sampling time when the second set of signals was generated.

[0201] In some examples, control unit 264 determines a difference between the post-recoil diameter and the pre-recoil diameter and compares the determined difference to the one or more recoil values. Based at least in part on the outcome of the comparison, control unit 264 can determine that an ovality is present. In some examples, in the event that the determined difference is different than the recoil average, or not present within the recoil value range described above, control unit 264 determines that an ovality is present. In some examples, control unit 264 determines the value of ovality based at least in part on a predetermined function of the outcome of the comparison. In some examples, the ovality is determined as described above in relation to the image-derived ovality.Attorney Docket No: TH VVA- 13387 WOOl

[0202] In some examples, wherein the position of a local resistance is known, such as a raphe in a bicuspid valve, or a significant calcific deposit, a further improvement to the ovality estimated can be made by re-orientation of C-arm 262. Particularly, in some examples, control unit 264 outputs at user output terminal 266 an instruction to orient C-arm 262 such that the raphe appears at the side of the valve, optionally at a 90 degree orientation in relation thereto.

[0203] Fig. 3 A shows a front view of frame 106aof prosthetic valve 100ain a slightly tilted orientation. It is noted that the illustrated orientation of frame 106 is relative to the plane of the page, which represents the plane of the image. In some examples, control unit 264 determines the height of prosthetic valve 100 in the front and the back, as described above. In some examples, the heights are used for determining the diameter of prosthetic valve 100. In some examples, control unit 264 compares the measured front height to the measured rear height to determine a height variance in prosthetic valve 100. The height variance indicates an uneven expansion of frame 106. In some examples, the height variance is caused by a variance in the areas of cells 132 and / or a variance in the angles of struts 112. When the orientation angle of frame 106 is large, as in Fig. 2 A, control unit 264 can differentiate between front and rear apices by the difference in their height. However, when the orientation angle of frame 106ais small, as in Fig. 3 A, control unit 264 may be unable to differentiate between front apices 116a and rear apices 116b.

[0204] In some examples, control unit 264 overcomes this issue by first identifying which of the axial frame members is in the front and which is in the rear, and then using that identification to measure the front and rear heights. As shown, frame 106ahas a plurality of proximal axial frame members 134a. In some examples, as shown in Fig. 1A, proximal axial frame members 134aare commissure support axial members 142a(not shown in Fig. 3 A). In some examples, some of the commissure support axial members 142acan provide a base for commissure attachment thereto, such as by including commissure window 146aor other commissure support features. In some examples, some of the proximal axial frame members 134acan be non-commissural axial stmts 117a. Each proximal axial frame member 134aextends between outflow vertices 1560 and the junctions 114 of the intermediate rung 110S adjacent to the outflow cell row 1480, as shown in Figs 1A-1B. The distance between outflow vertices 1560 and the junctions 114 defines the length of the proximal axial frame member 134a, and the lengths of all proximal axial frame members 134ashould be equal. In some examples, the lengths of proximal axial frame members 134aalso do not change during expansion of prosthetic valve 100a. However, when looking at proximal axial frame members 134ain a 2D image, this may not be the case.Attorney Docket No: TH VVA- 13387 WO01

[0205] Fig. 3B shows an illustrative concept of the difference in length within an image of identical structures. As shown, the size of radiation beam 350 of imager 260 increases as it progresses. Thus, the size of radiation beam 350 will be larger when hitting a proximal axial frame member 134ab, that is in the rear, than when hitting a proximal axial frame member 134aa that is in the front. As a result, front proximal axial frame member 134aa will appear in the image to be larger than rear proximal axial frame member 134ab, thereby providing a feature that allows the front and rear axial frame members to be identified.

[0206] Fig. 3C shows a flow chart for a method of determining height variance in a prosthetic valve. In step 1400, an image is received showing an expanded prosthetic valve, as described above. In some examples, the image is a 2-dimensional image showing the prosthetic valve in an image plane. The term "image plane", as used herein means the plane of the 2-dimensional image. Thus, the terms "front" and "back" are defined in relation to the image plane. In step 1410, control unit 264 identifies proximal axial frame members 134a. In some examples, proximal axial frame members 134aare identified utilizing one or more shape detection algorithms. In some examples, proximal axial frame members 134aare identified utilizing a trained CNN model. In some examples, proximal axial frame members 134aare identified utilizing Davis conjections. In some examples, proximal axial frame members 134aare identified by defining a mask of the frame 106aand comparing the image to the mask.

[0207] In step 1420, a position of each of the proximal axial frame members 134ain relation to the image plane are determined. In some examples, the front proximal axial frame member, or members 134aa are identified. Similarly, the rear proximal axial frame member, or members 134ab, are identified. A front proximal axial frame member 134aa is thus between the image plane and the imager, i.e., in front of the page, and a back proximal axial frame member 134ab is beyond the image plane, i.e., behind the page. As described above, control unit 264 measures the length of each proximal axial frame member 134a, and the larger the length is, the closer to the front it is. Thus, control unit 264 can determine which proximal axial frame members 134aa are in the front and which proximal axial frame members 134ab are in the rear.

[0208] In step 1430, based at least in part on the identification of the front and rear proximal axial frame members 134a, control unit 264 identifies front apices 116a and rear apices 116b. It is noted that the above is described in relation to front apices 116a and rear apices 116b, however the same method can be used for identifying front apices 118a and rear apices 118b.

[0209] In some examples, control unit 264 identifies front apices 116a as being connected, by angled struts 108, to front proximal axial frame members 134aa. Similarly, control unit 264 identifies rear apices 116b as being connected, by angled struts 108, to rear proximal axialAttorney Docket No: TH VYA- 13387 WO01 frame members 134ab. In some examples, control unit 264 identifies front apices 118a as being connected, by angled struts 108, to front proximal axial frame members 134aa. Similarly, control unit 264 identifies rear 162 118b as being connected, by angled struts 108, to rear proximal axial frame members 134ab. As described above, other points on frame 106acan be identified, in addition to, or instead of, apices.

[0210] In step 1440, the front and rear heights of prosthetic valve 100 are measured by control unit 264. In some examples, the front height is defined as the distance between opposing front apices 1 16a and 1 18a, and the rear height is defined as the distance between opposing rear apices 116b and 118b. It is noted that the above has been described in relation to the identification of two proximal axial frame members 134a. however this is not meant to be limiting in any way. In some examples, the heights of prosthetic valve 100 at the sides thereof, i.e., at the edges shown in the image, are measured. Thus, in some examples, control unit 264 determines 4 heights of prosthetic valve 100, as described above.

[0211] In some examples, control unit 264 determines the ratio between the length of front proximal axial frame member 134aa and the rear proximal axial frame member 134ab, and adjusts the measurement of the front height or the rear height by the determined ratio. Thus, the determined front and back heights are now calculated without the effects of the distance from the radiation source.

[0212] In some examples, the heights of prosthetic valve 100 at the sides thereof, i.e., at the edges shown in the image, are measured. Thus, in some examples, control unit 264 determines 4 heights of prosthetic valve 100, as described above.

[0213] In step 1450, the height variance of prosthetic valve 100 is determined by control unit 264 by determining a difference between the determined heights. In some examples, an average of the determined heights is determined and the height variance is determined as differences between the determined heights and the determined average. In some examples, control unit 264 displays an indication of the height variance on user output terminal 266.

[0214] As described above, based on the measured heights and measured diameters, in pixels, control unit 264 can determine the pixel size. From this, control unit 264 can also determine the distance X between the radiation source and the front proximal axial frame member 134aa, given as:X = D*la*(la - lb) EQ. 2 where D is the diameter of prosthetic valve 100, la is the measured length of front proximal axial frame member 134aa and lb is the measured length of rear proximal axial frame member 134ab.Attorney Docket No: TH VVA- 13387 WO01

[0215] In some examples, the front and rear heights can each be normalized as follows: Ha(normalized) = Ha*X(X + D / 2) EQ. 3 where Ha is the measured front height;Hb(normalized) = Hb*(X + D) / (X + D / 2) EQ. 4 where Hb is the measured rear height. Thus, in some examples, where it is difficult to measure the lengths of proximal axial frame members 134a, due to resolution issues, the heights Ha and Hb, which are measured in units of pixels, can be converted to measurements in millimeters by control unit 264 in accordance with EQs. 3 and 4. In some examples, distance X is a known value. In some examples, diameter D is determined in accordance with the examples described above.

[0216] In some examples, based at least in part on a determination that a height variance is present, control unit 264 controls pump 340 to further inflate balloon 234, thereby increasing the expansion of frame prosthetic valve 100. As described above, in some examples, control unit 264 can control a respective actuator to allow for further expansion of a mechanically expandable, or self-expandable, valve.

[0217] Fig. 4 A shows a front view of frame 106a, exhibiting central axis Ca. As shown in Fig. 1 A, prosthetic valve 100 comprises leaflets 122. In the event that frame 106adoes not expand symmetrically, this will cause regional under-expansion which can result in leaflets 122 hitting and abrading against frame 106a. Regional under-expansion can be caused by the expansion of frame 106aafter being crimped. In some examples, as will be described below, control unit 264 can identify regional under-expansion.

[0218] As described above, control unit 264 identifies each proximal axial frame member 134aand measures their lengths. Control unit 264 then can identify the position of each proximal axial frame member 134ain relation to the image plane. In some examples, central axis Ca is defined within the image plane. In some examples, control unit 264 then defines the positions of proximal axial frame members 134ain relation to a circle whose center coincides with central axis Ca and the image plane. Fig. 4C shows a conceptual diagram of frame 106a, with 3 proximal axial frame members 134awith distances xl, x2 and x3 from central axis Ca, respectively.

[0219] Control unit 264 measures the distance between each proximal axial frame member 134aand central axis Ca, i.e., distances xl, x2 and x3.

[0220] Fig. 4B shows a conceptual diagram of the arc angles of the frame. In some examples, control unit 264 calculates angles a as follows: al = -cos-1(xl / r) EQ. 5Attorney Docket No: TH VVA- 13387 WO01 where r = D / 2, D being the diameter of frame 106a; a2 = cos1(x2 / r) + 90 EQ. 6 a3 = -cos-1(x3 / r) EQ. 7

[0221] In some examples, diameter D is determined as described in the above examples. Control unit 264 then calculates angles 0 as follows:01 = a2 - al; 02 = a3 - a2; 03 = al + (360 - a3); EQs. 8 - 10 where each arc length is equal to r*0, utilizing the respective angle 0.

[0222] If the arc lengths are not equal, control unit 264 determines that there is regional underexpansion. In some examples, the control unit 264 compares the determined arc length to the expected arc length (e.g., 120 degrees) and outputs a value indicating the amount of underexpansion. In some examples, the value is a predetermined function of the difference between the determined arc length and the expected arc length.

[0223] Fig. 5B shows cross-sectional view of a prosthetic valve 100bimplanted in a mitral valve. Prosthetic valve 100bis in all respects similar to prosthetic valve 100, with the exception of being used in combination with a docking device 410, against which it is secured when implanted, for example, within the native mitral valve. The securing of prosthetic valve 100bagainst docking device 410 is such that the portion of the prosthetic valve 100bexpanded against the docking device 410 defines a narrower portion, relative to wider inflow and outflow end portions of the prosthetic valve 100b.

[0224] Docking device 410 is illustrated separately in Fig. 5C, and is illustrated in Fig. 5D wrapped around frame 106b. In some examples, docking device 410 has a functional coil / turn region or central region 412 and an encircling turn or lower region 414. The docking device 410 can also, optionally, have an upper region 416. The lower region 414 includes one or more turns that can be configured to encircle or capture the chordae tendineae and / or the leaflets of a native valve, such as the mitral valve or tricuspid valve. The central region 412 includes a plurality of turns configured to retain the prosthetic valve at the native valve. The upper region 416 can include one or more turns, and can be configured to keep the docking device from being dislodged from the valve annulus prior to implantation of the prosthetic valve. In some examples, the upper region 416 can be positioned over the floor of the atrium, and can be configured to keep the turns of the central region 412 positioned high within the native valve apparatus.

[0225] As shown in Figs. 5A and 5D, docking device 410 can cause frame 106bto bend, thereby forming an hour-glass shape. In some examples, control unit 264 is configured toAttorney Docket No: TH VYA- 13387 WO01 measure the diameters, at several heights of frame 106b, while taking into account the curves of the frame 106b.

[0226] In some examples, as shown in Fig. 5A, control unit 264 identifies an arc 420 on each side of frame 106b. These arcs are further shown as a conceptual diagram in Fig. 5F. In some examples, control unit 264 can identify an outflow end 422, and inflow end 424 and a central point 426 of the arc 420, even without identifying the entire arc. It is noted that term “central point,” as used herein, means a point at or approaching the center of the arc. In some examples, central point 426 can be identified by identifying the deepest point of the edge of the frame 106b. It is further noted that by identifying the deepest point in the edge of the frame 106b, central point 426 may be defined closer to one of the ends of the arc than the other.

[0227] For each arc 420, control unit 264 can derive the coordinates of the center of the circle defining the corresponding arc, in accordance with the diagram of Fig. 5E. Considering A as point 1 , C as point 2, B as point 3 and F (the circle center) as point 4, control unit 264 defines the following:Slope AB is defined as (y3 - y 1 ) / (x3 - xl); Slope BC is defined as (y2 - y3) / (x2 - x3)

[0228] As known, the center of a circle through 3 vertices of a triangle is the meeting point of the perpendicular bisectors of the sides of the triangle. Thus, the following is derived: Slope DF = -Slope AB = (yl - y3) / (x3 - xl); Slope EF = -Slope BC = (y3 - y2) / (x2 - x3)

[0229] From this we can derive the following:X (circle center): X = ((y2 — yl) — (x3 — xl)(x2 — x3)) / (2((yl — y3)(x2 — x3) —( 3 - y2)(x3 - xl)) EQ. 11... . , ,Y(vcircle center):

[0230] The radius R of the circle is then calculated by control unit 264 as the distance between the center of the circle and any of the points A, B or C.

[0231] Control unit 264 then calculates the arc's angle 6 as:0 = 2*tan(BD / DF) + 2*tan(BE / EF) EQ. 12

[0232] The arc length L is then calculated by control unit 264 as follows:L = R* 0 EQ. 13

[0233] The arc length is similarly determined for the other arc as well. In some examples, control unit 264 further calculates an average of the two arc lengths. It is noted that the more circular the arc is, the more accurate the calculation will be.Attorney Docket No: TH VYA- 13387 WO01

[0234] In some examples, control unit 264 further determines the front, rear, left and right heights of frame 106, as described above. In some examples, control unit 264 calculates the following proportion P:P = (the mean between the left and right arc lengths) I (the mean between the left and right heights) EQ. 14

[0235] In some examples, control unit 264 estimates the average arc length by multiplying proportion P by the (mean between the front and back heights).

[0236] In some examples, control unit 264 determines the diameter of frame 106, as described above, however the height H is replaced with the averaged arc length.

[0237] Fig. 6 shows a conceptual illustration of a part of a method of determining a diameter of a prosthetic valve within an image.

[0238] In some examples, as described above, the diameter of frame 106 is determined based at least in part on the ratio of H / D, i.e., the ratio of the height of frame 106 to the diameter of frame 106. As described above, the diameter of frame 106 can be determined using the ratio H / D and a predetermined function, look-up table, or other reference.

[0239] In some examples, as described above, an image showing the prosthetic valve 100 is received. As described above, the image can be a fluoroscopy image, however this is not meant to be limiting in any way.

[0240] In some examples, two neural networks (NNs) stored on memory 267 are utilized by control unit 264 to determine the diameter of frame 106, which defines the frame of prosthetic valve 100, as described above. In some examples, the neural networks are convolutional neural networks. In some examples, one of the NNs is denoted a feature identification NN and is utilized so as to identify a plurality of features of the prosthetic valve 100. In some examples, a second of the NNs is denoted an ROI NN and is utilized to define an ROI within the image, as will be described below. In some examples, as will be described below, the output of the ROI NN is fed into the input of the feature identification NN. In some examples, prior to the input into the feature identification NN, further processing is performed on the image. In some examples, as will further be described below, the ROI NN comprises a YOLO Oriented Bounding Box (OBB) neural network and the feature identification NN comprises a U-Net neural network. Although the present examples are described in relation to a method utilizing two neural networks, this is not meant to be limiting in any way, and the present method can be performed utilizing only a single neural network, without exceeding the scope of the disclosure.Attorney Docket No: TH VVA- 13387 WO01

[0241] In some examples, as described above, the ROI NN is utilized to define an ROI within the image such that the defined ROI comprises the prosthetic valve. In some examples, an orientation of the prosthetic valve 100 is determined and the orientation of the ROI is adjusted accordingly. In some examples, the orientation of the prosthetic valve 100 is determined based at least in part on a classification based technique. In some examples, for training of the ROI NN, a plurality of classes are defined, each representing a respective angle. In some examples, 180 classes are defined, each representing a separate angle from 1 to 180, however this is not meant to be limiting in any way and any number of classes may be utilized without exceeding the scope of the disclosure.

[0242] In some examples, the classification based technique comprises a circular smooth label (CSL) technique. A CSL is the value of a window function that converts the angle vale to the function value, where the function exhibits the following properties:A. periodicity, defined as g(x) = g(x +kT), where T represents the number of bins into which the angle range is divided and k is an integer;B. symmetry, where the function is symmetrical relative to the value of the angle;C. the maximum of g(x) is equal to 1; andD. monotonicity, where the function presents a monotonous, non-increasing trend from the center point to both sides, wherein the center point represents the angle.

[0243] In some examples, an angular loss value is determined with a binary cross-entropy loss function.

[0244] In some examples, the last 2D convolutional layer of the angle prediction of the ROI NN predicts an n-dimensional vector representing CSL function values, with the index of the maximum element being the class of the angle, 'n' is the number of classes.

[0245] In some examples, utilizing a classification based technique provides for greater accuracy in identifying the orientation of the prosthetic valve 100.

[0246] In some examples, the feature identification NN receives the image with the defined ROI. As described above, in some examples, the feature identification NN further receives the orientation angle of the ROI or the orientation of the prosthetic valve 100.

[0247] In some examples, the feature identification NN identifies a first plurality of parameters defining a respective ellipse at a first portion of the prosthetic valve 100 and a second plurality of parameters defining a respective ellipse at a second portion of the prosthetic valve 100. The term "defining a respective ellipse", as used herein, means that an ellipse can be defined utilizing the parameters, without additional information.Attorney Docket No: TH VVA- 13387 WO01

[0248] In some examples, the first portion of the prosthetic valve 100 is the outflow end 102 and the second portion of the prosthetic valve 100 is the inflow end 104. However, this is not meant to be limiting in any way, and in some examples the first plurality of parameters and second plurality of parameters can be identified at any two heights of the prosthetic valve 100. For example, the first plurality of parameters and second plurality of parameters can be identified at opposing ends of one or more rows of cells of frame 106. As described above, the D parameter in the ratio H / D can be determined at any of a plurality of heights.

[0249] In some examples, each plurality of parameters defining an ellipse comprises 3 or 4 points. In some examples, each plurality of parameters defining an ellipse consists essentially of 3 or 4 points. In some examples, for the first plurality of parameters, a first point 501a is defined at the front or rear of the frame 106, a second point 501b is defined at a side of the frame 106 and a third point 501c is defined at the center of the frame 106. A fourth point (not shown) can further be identified for greater accuracy. Similarly, for the second plurality of parameters, a first point 502a is defined at the front or rear of the frame 106, a second point 502b is defined at a side of the frame 106 and a third point 502c is defined at the center of the frame 106. A further point (not shown) can further be identified for greater accuracy. Utilizing 3 points, a pair of vectors can be defined which correspond to the radii of the ellipse.

[0250] Although the present examples are described herein in relation to the identification of a plurality of points that define an ellipse, this is not meant to be limiting in any way, and other parameters can be identified, such as vectors defining the ellipse radii, or a plurality of points defining curves of the circumference of the ellipse.

[0251] In some examples, based at least in part on the identified first plurality of parameters and second plurality of parameters, the diameters of the two ellipses are determined. As described above, in some examples an average of the two diameters are determined and utilized for the H / D ratio. In some examples, as described above, each ellipse diameter is utilized for determining a separate diameter of the prosthetic valve 100, each at a separate height. Although the present examples are described herein in relation to a pair of determined diameters, this is not meant to be limiting in any way and any number of ellipse diameters can be determined, without exceeding the scope of the disclosure. As further described above, in some examples only a single diameter is determined from the ellipse, which is then used for determining the diameter of the prosthetic valve 100, either utilizing the H / D ratio or other technique.

[0252] As described above, in some examples the diameter of the prosthetic valve 100 is determined utilizing a measured height of the prosthetic valve and the H / D ratio. In some examples, the feature identification NN further identifies a third set of points, comprising oneAttorney Docket No: TH VVA- 13387 WO01 or more points between outflow end 102 and inflow end 104. In some examples, the third set of points comprises a first point 503 and a second point 504, each on opposing sides of frame 106. In some examples, the height of the prosthetic valve is measured by fitting a curve through the respective point 503 or 504, where a first end of the curve starts from the first ellipse and the second end of the curve starts from the second ellipse. As described above, the determined height, or heights, can be utilized for determining the H / D ratio, and then the H / D ratio is utilized for determining the diameter of the prosthetic valve 100.

[0253] Although the above described examples utilize identified points, this is not meant to limit the output of the feature identification NN to a plurality of points. In some examples, the feature identification NN is trained to output, for each of the plurality of points, a heatmap that represents a 2D probability distribution of a pixel belonging to a specific class, with the class being the respective point.

[0254] In some examples, the above described examples, utilizing the ROI NN and feature identification NN, in conjunction with the H / D ratio, allow an accurate measurement of the diameter of the prosthetic valve with a small training dataset. In some examples, utilizing points for identifying both the ellipse diameter and the valve height allows the use of a single neural network for the feature identification, after defining the ROI.

[0255] In some examples, for each of the inflow end 104 and outflow end 102 of frame 106, the respective diameter can be determined by determining the major diameter of the respective ellipse. In some examples, as described above, a tilt angle 0 of frame 106 can be determined by control unit 264 by determining a ratio of the minor ellipse diameter to the major ellipse diameter. Thus, as described above, control unit 264 can adjust the height measurement to take into account the measured tilt angle 0, and determine the actual height H.

[0256] As described above, in relation to Figs. 3 - 4, it may be desired to differentiate between the front and rear of the frame 106. In some examples, difficulties can arise because frame 106 is not perfectly cylindrical. In some examples, differentiating the front and rear can aid in accurate procedure guidance and post-deployment assessment. However, current solutions might require multiple imaging angles (stereoscopy), increasing procedure time and radiation exposure.

[0257] In some examples, control unit 264 can comprise an image acquisition module stored in memory 267 and configured to acquire sequential fluoroscopic images of frame 106 from imager 260. Control unit 264 can further comprise an orientation determination module stored in memory 267 and executed by processors 265, the orientation determination moduleAttorney Docket No: TH VVA- 13387 WO01 configured to analyze differential movement patterns between the sequential images to determine which portions of frame 106 are closer to imager 260.

[0258] In some examples, the orientation determination module of control unit 264 can implement sequential image differential movement analysis that builds upon the elliptical contour detection methods described above. Referring to Fig. 7, in some examples control unit 264 identifies elliptical contours at inflow end 104 and outflow end 102 when prosthetic valve 100 is tilted relative to imager 260, such as by identifying apices, as described above. In some examples, ellipses are defined at inflow end 104 and outflow end 102 based on identification of a plurality of points, as described above.

[0259] In some examples, control unit 264 defines reference points where the major axis intersects the ellipse perimeter (designated as points 'a' and 'b'), and where the minor axis intersects the ellipse perimeter (designated as points 'c' and 'd'), with the major axis serving as the x-axis reference line. In some examples, control unit 264 measures the distances from the upper ellipse point 'c' and lower ellipse point 'd' to the major axis reference line, i.e., the x-axis, in each of a plurality of sequential fluoroscopic images. Control unit 264 then determines the changes in these distances between the sequential images, which essentially defines the displacement of points c and d relative to the x-axis. Objects closer to imager 260 will show larger displacements between consecutive images. Thus, control unit 264 determines which point is displaced the most between consecutive images, which is then defined as being in the front, with the other point defined as being in the rear. In some examples, this analysis can be performed through sequential images while skipping some of the images. For example, the analysis can be performed every 2 images, every 3 images, or every n images, where n is a predetermined number.

[0260] In some examples, control unit 264 designates the arc of the ellipse along the front side as the "front" and the arc along the rear side as "rear". In the illustrative example of Fig. 7, arc 'acb' is designated as the "front" arc, and arc 'adb' is designated as the "rear" arc. In some examples, control unit 264 designates apices along the "front" arc as "front" apices and designates apices along the "rear" arc as "rear" apices. In some examples, this can create a complete 3D spatial understanding from 2D sequential imaging data stored in memory 267, and can eliminate need for stereoscopic imaging or multiple view angles.

[0261] In some examples, control unit 264 can identify changes in the minor diameter of the respective ellipse, and apply a predetermined function to determine the change in length of each radius on the minor diameter through the subsequent images. This is equivalent toAttorney Docket No: TH VVA- 13387 WO01 determining displacement of points 'c' and 'd'. Thus, the radius that changes more between subsequent images will indicate that it is closer to the imager 260.

[0262] Although in the above described method, the displacement of points on the frame are determined in relation to axes of the frame, this is not meant to be limiting in any way. In some examples, the displacements of the various points are determined in relation to axes of the entire image. In such examples, one or more axes of the image are defined, and the distance between the points on the frame and the respective axis are determined in each of the sequential images, as described above.

[0263] In some examples, control unit 264 determines an average of the displacements, and the determination of which point is displaced the most is based on the average of the displacements.

[0264] In some examples, the orientation determination module can implement statistical confidence enhancement stored in memory 267. In some examples, control unit 264 implements a statistical voting mechanism.

[0265] In some examples, in relation to points 'c' and 'd', control unit 264 counts the number of times points 'c' and 'd' are identified as "front" or "back" across sequential images, and determines which side has a higher probability of being the front through frequency analysis.

[0266] For example, in each image, the respective point is defined as being in the front if the displacement in the distance from the axis is greater than the displacement of the other point. Then, control unit 264 counts in how many images each point was defined as being in the front, and the point with the highest number of images where it was defined as being in the front is ultimately designated as being in the front. It is noted that this is not meant to be limiting in any way, and any type of statistical analysis can be performed on the plurality of sequential measurements to determine which point is in the front and which is in the rear.

[0267] In some examples, control unit 264 can determine displacement magnitude by measuring pixel-based movement of identified points between consecutive images using the distance measurement methods described above. The change in distance of point 'c' between each two subsequent images can represent the movement of the lower side of the ellipse, and the same measured for point 'd' can represent the movement of the upper side of the ellipse. Control unit 264 can store these displacement measurements in memory 267 and can analyze the displacement patterns to identify which side exhibits greater movement relative to imager 260.

[0268] In some examples, control unit 264 can implement measurement approaches that focus on specific axis movements. The orientation determination module can measure the change inAttorney Docket No: TH VYA- 13387 WO01 the y-axis of the ellipse (short axis of the ellipse), or in the screen's y-axis displayed on user output terminal 266. This can reduce computational complexity while maintaining spatial orientation accuracy for cases where frame 106 exhibits primarily vertical or horizontal tilting relative to the imaging plane.

[0269] The above described method is based on displacement that naturally occurs between subsequent images, however displacement can also be manually introduced. In some examples, control unit 264, or the technician / physician, can shift C-arm 262 in the X and / or Y direction to introduce such a displacement. In some examples, a shift of 10 - 50 mm is introduced. As described above, the closer a point on the frame is the imager, the greater the displacement will be in the image. Thus, as described above, control unit 264 can identify the differences in displacement and determine the front and / or rear of the frame based on the measured displacement. In some examples, each shift of 10 mm causes a difference of one pixel within the image. In some examples, control unit 264 identifies the differences in displacement within a plurality of consecutive images and determines an average of the displacement differences. In some examples, control unit 264 determines the front and / or rear of the frame based at least in part on the average displacement.

[0270] In some examples, the above method can be performed assuming that the frame tilts relative to the imaging plane, without rotating about its longitudinal axis, and maintains a relatively rigid 3D shape throughout the imaging sequence.

[0271] In some examples, control unit 264 can seamlessly extend functionality of the algorithms described above, can build upon the established valve contour detection capabilities described above, can provide additional spatial information without requiring new imaging protocols from imager 260, and can enhance overall valve assessment without increasing procedural complexity. In some examples, the spatial orientation determination can integrate with the diameter measurement systems described above by providing enhanced accuracy for height and diameter calculations when prosthetic valve 100 is tilted. Control unit 264 can use the determined front / rear classification to improve the tilt angle compensation methods described above, can enhance the H / D ratio calculations by providing more accurate height measurements, and can store the orientation data in memory 267 for use in subsequent analysis steps. This sequential image analysis approach can enable control unit 264 to extract three- dimensional orientation information from standard two-dimensional fluoroscopic images, eliminating the need for stereoscopic imaging or multiple viewing angles while maintaining procedural efficiency and providing critical spatial orientation data for enhanced prosthetic valve deployment guidance.Attorney Docket No: TH VVA- 13387 WO01

[0272] In some examples, control unit 264 can be configured for selective display of real-time diameter measurements during prosthetic valve 100 expansion procedures. The term "threshold-based diameter display," as used herein, refers to a user interface approach where control unit 264 presents diameter information on user output terminal 266 when the measured diameter exceeds a predetermined percentage of a target expansion diameter. During balloon inflation procedures, it can be desirable to attract the clinician's attention specifically to the final stage of inflation when precise diameter control becomes critical for optimal valve deployment.

[0273] In some examples, control unit 264 can comprise a display management module stored in memory 267 and executed by processors 265, the display management module configured to selectively present diameter information based on expansion progress thresholds. Control unit 264 can further comprise a target diameter input module stored in memory 267 and configured to receive clinician-specified target expansion parameters through user input terminal 268.

[0274] In some examples, the target diameter input module can implement enhanced valve sizing selection that builds upon the diameter measurement methods described above. Control unit 264 can present an initial configuration interface on user output terminal 266 prior to procedure initiation, can prompt the clinician to select a valve size which defines the working range of the valve (e.g., 20, 23, 26, 29) through user input terminal 268, and can subsequently present specific target diameter options associated with the selected size using the valve type classification methods described above. The term "valve size selection," as used herein, refers to the initial categorization step where control unit 264 receives input indicating the general size category of prosthetic valve 100. In some examples, control unit 264 can store in memory 267 a database of valve specifications that correlate valve sizes with corresponding diameter ranges. For a selected size, control unit 264 can present a refined selection interface displaying specific target diameter values (e.g., 27.8, 28.0, 28.4, 28.8...30 mm) that correspond to the working size range of the selected valve type.

[0275] In some examples, control unit 264 can implement a cascading selection process where the first user input determines the valve category, and the second user input specifies the precise target diameter for the procedure. This approach can accommodate the fact that each prosthetic valve 100 can have a working size range rather than a single fixed diameter, allowing clinicians to optimize expansion targets based on patient-specific anatomical considerations.

[0276] In some examples, the display management module can implement threshold-based presentation logic executed by processors 265. Control unit 264 can continuously calculate theAttorney Docket No: TH VVA- 13387 WO01 real-time diameter of prosthetic valve 100 during the entire expansion procedure using the diameter measurement methods described above, can compare the determined diameter to a percentage threshold of the target diameter stored in memory 267, and can optionally selectively activate diameter display on user output terminal 266 only when the measured diameter exceeds the predetermined threshold. The term "diameter display threshold," as used herein, refers to a percentage value of the target diameter that triggers the activation of realtime diameter presentation. In some examples, control unit 264 can use a default threshold of 90% of the target diameter, though other percentage values can be configured, such as 80%, 85%, or 95%. As a specific example, for a target diameter of 29.6 mm, control unit 264 can begin displaying diameter information when the measured diameter exceeds approximately 26.6 mm (90% threshold).

[0277] In some examples, control unit 264 can store multiple threshold values in memory 267 for different procedural phases or valve types. The display management module can select the appropriate threshold based on valve specifications, procedural requirements, or clinician preferences input through user input terminal 268.

[0278] In some examples, control unit 264 can implement multiple presentation formats for diameter information on user output terminal 266. The display management module can present diameter values as numerical readouts, can display progress using horizontal bar indicators, can combine numerical and graphical representations for enhanced visibility, and can provide visual target indicators that assist with precision expansion control.

[0279] In some examples, control unit 264 can present a target bar on user output terminal 266, such as a horizontal target bar, that represents the desired final diameter including expected recoil compensation using the recoil values described above. This visual aid can help clinicians identify when the measured diameter approaches the target value and when to cease balloon 234 inflation.

[0280] In some examples, control unit 264 can implement progressive visual enhancements as the diameter approaches the target value. The display management module can modify color coding, adjust numerical formatting, increase update frequency of diameter readings, and provide additional visual cues that emphasize proximity to the target diameter. In some examples, an adjustment of the color of the bar, an adjustment of the numerical formatting, an increase in the update frequency of diameter readings and / or additional visual cues are performed upon the measured diameter reaching: a respective distance from the target diameter: or a respective percentage of the target diameter. In some examples, as describedAttorney Docket No: TH VVA- 13387 WO01 above, the distance to the target diameter, or the percentage of the target diameter, is calculated based at least in part on the expected diameter after recoil.

[0281] In some examples, the bar includes a marker showing the distance from the target diameter. In some examples, the bar fills up as the diameter increases, and a warning is output together with the bar passing the marker.

[0282] In some examples, the threshold-based display system can integrate seamlessly with the diameter determination methods described above. Control unit 264 can utilize the expected expansion diameter calculations described above to account for recoil when determining target achievement, can incorporate the H / D ratio measurement techniques for accurate diameter assessment, and can leverage the neural network-based diameter identification methods for reliable real-time measurements during the threshold evaluation process. In some examples, control unit 264 can coordinate the threshold-based display with the automatic expansion control systems described above. When the measured diameter reaches the target value (accounting for expected recoil), control unit 264 can simultaneously trigger display updates and expansion cessation commands to pump 340, providing integrated procedural control that enhances both user awareness and procedural automation.

[0283] In some examples, the selective display approach can provide clinical advantages by focusing physician attention on the critical final expansion phase. Control unit 264 can reduce information overload during early expansion stages, can direct clinician focus to the target zone when precision becomes essential, can minimize distraction during less critical procedural phases, and can enhance procedural efficiency by providing information precisely when it becomes most relevant. Rather than providing continuous diameter readings that may distract from other procedural aspects, control unit 264 can time the information presentation to coincide with the procedural phase where diameter monitoring becomes most critical. In some examples, control unit 264 can implement additional attention-directing features such as audio alerts when the threshold is reached, visual highlighting of the diameter display area, automatic adjustment of display brightness or contrast, and integration with other procedural notifications to create a cohesive attention management system.

[0284] In some examples, control unit 264 can store the threshold-based display preferences in memory 267 as part of procedural protocols. The display management module can adapt threshold values based on valve type, can modify presentation formats based on procedural phase, can coordinate with rapid pacing controls described above to optimize information timing, and can integrate with the inflation control systems described above to provide comprehensive procedural guidance. This threshold-based approach can advantageously focusAttorney Docket No: TH VVA- 13387 WO01 clinician attention on the final stage of inflation, providing critical diameter information precisely when precision control becomes most important while reducing information overload during earlier procedural phases. The system enhances procedural safety and efficiency by delivering the right information at the right time during prosthetic valve 100 deployment.

[0285] In some examples, control unit 264 can be configured for adapted diameter measurement algorithms specifically designed for prosthetic valves that do not foreshorten during expansion. The term "non-foreshortening valve," as used herein, refers to prosthetic valve designs where frame 106 maintains a constant, or near-constant, height throughout the expansion procedure, as described below in relation to Figs. 9A - 10B.

[0286] In some examples, control unit 264 can comprise a valve type classification module stored in memory 267 and executed by processors 265, the valve type classification module configured to identify non-foreshortening valve characteristics and adapt measurement algorithms accordingly. Control unit 264 can further comprise a calibration module stored in memory 267 and configured to utilize the constant frame height as a calibration reference for pixel-to-millimeter conversion during diameter measurements.

[0287] In some examples, the calibration module can implement height-based calibration that leverages the constant frame height characteristic of non-foreshortening valves. Since frame 106 height remains constant throughout the procedure, control unit 264 can use the height as a calibration measure and compare the measured height in pixels to the known height in millimeters stored in memory 267. Thus, in some examples, control unit 264 can establish a pixel-to-millimeter conversion factor that remains valid throughout the expansion procedure. As described above, "height calibration factor," as used herein, refers to a conversion ratio calculated by control unit 264 by dividing the known physical height of frame 106 by the measured height in pixels within the fluoroscopic image, or expressed as a simple equation, calibration factor = known height (mm) I measured height (pixels). In some examples, control unit 264 can store valve-specific height specifications in memory 267 and can measure the pixel height using the height measurement methods described above.

[0288] In some examples, the height-based calibration approach can potentially provide advantages over alternative calibration methods since utilizing the entire length of frame 106 for calibration can provide a more accurate calculation.

[0289] In some examples, control unit 264 can implement height measurement algorithms specifically adapted for non-foreshortening valve geometries. The calibration module can execute multiple correction algorithms to ensure accurate height measurement, building upon the methods described above while adapting for the unique characteristics of non-Attorney Docket No: TH VVA- 13387 WO01 foreshortening designs. In some examples, control unit 264 can implement multi-point height averaging using the spatial orientation determination methods described above. As described above, control unit 264 can measure height at four locations within the image: the left and right sides of frame 106, and the front and rear portions of frame 106. Control unit 264 can identify front and rear portions using the spatial orientation determination methods described above, can calculate an average of the four measured height values, and can use this averaged height for improved calibration accuracy.

[0290] In some examples, control unit 264 can implement tilt correction algorithms, as described above. Control unit 264 can account for possible tilting of frame 106 such that the actual height can be derived from the projected height visible in the image, which can be either equal to the actual height or smaller than the actual height depending on the valve orientation relative to imager 260, as described above and further illustrated in Fig. 8. As described above, the measured height is actually HcosG, and thus control unit 264 can adjust the measured height with the correct trigonometric relationship to determine the actual height H.

[0291] As further described above, in some examples control unit 264 can identify ellipses at inflow end 104 and outflow end 102 even in the absence of clearly defined apices present at the sides of prosthetic valve 100. In some examples, as described above, these ellipses can be used for determining the tilt thereof.

[0292] In some examples, control unit 264 can implement enhanced contour detection methods that identify the outer boundaries of frame 106 at inflow end 104 and outflow end 102. The calibration module can process these contours using ellipse-fitting algorithms executed by processors 265, can determine the major and minor axes of the fitted ellipses, and can extract diameter measurements from the elliptical geometry using the geometric analysis methods described above.

[0293] In some examples, the non-foreshortening valve adaptation can integrate with existing diameter measurement systems described above while providing enhanced accuracy for specific valve types. Control unit 264 can maintain compatibility with the H / D ratio methods described above, recognizing that while H / D ratios still change as the diameter changes in nonforeshortening valves, the change in H / D ratio is not as profound as in valves that do foreshorten. In some examples, control unit 264 can implement hybrid measurement approaches that combine height-based calibration with traditional H / D ratio analysis. The calibration module can use the constant height for pixel-to-millimeter conversion and apply this calibration to diameter measurements obtained through the methods described above,Attorney Docket No: TH VVA- 13387 WO01 providing enhanced accuracy for non-foreshortening valve types while maintaining compatibility with existing measurement frameworks.

[0294] In some examples, control unit 264 can implement automatic valve type detection to select appropriate measurement algorithms. The valve type classification module can analyze frame 106 characteristics during initial imaging, can identify indicators of foreshortening vs. non-foreshortening design, can automatically select the appropriate measurement algorithm set, and can store the valve type classification in memory 267 for consistent algorithm application throughout the procedure. In some examples, control unit 264 can monitor height measurements over multiple images during initial expansion phases, can analyze height stability patterns, and can classify the valve as foreshortening or non-foreshortening based on observed height behavior.

[0295] In some examples, the height-based calibration approach can potentially provide measurement accuracy improvements for non-foreshortening valves. Control unit 264 can establish a more stable calibration reference using the constant frame height, can reduce measurement uncertainties associated with smaller frame features, can maintain calibration accuracy throughout the expansion procedure, and can provide enhanced precision for diameter measurements and procedural guidance. In some examples, control unit 264 can store multiple calibration factors in memory 267 for different non-foreshortening valve types, can automatically apply the appropriate calibration based on valve identification, and can provide real-time diameter measurements with enhanced accuracy specifically optimized for nonforeshortening valve characteristics. This adaptation extends the utility of the real-time diameter measurement systems described above to encompass non-foreshortening valve designs, providing accurate measurement capabilities across a broader range of prosthetic valve technologies while maintaining the procedural guidance and safety benefits of real-time diameter monitoring.

[0296] Figs. 9A-9B show an exemplary prosthetic valve 100c. The prosthetic valve 100cis an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that the height of the frame, defined as the axial distance between the inflow end 104 and outflow end 102 of the frame 106c, does not change between the radially crimped and expanded states of the frame.

[0297] The frame 106ccomprises a plurality of axial frame members 150c. Each axial frame member 150ccan be comprised of axial segments 152c, wherein an axial segment 152cof an axial frame member 150cis defined as a portion of the corresponding axial frame member 150cAttorney Docket No: TH VVA- 13387 WO01 extending between axially-adjacent joints 154 of the same axial frame member 150c. The inflow end 104 and outflow end 102, coincide with the ends of the axial frame members 150c.

[0298] As illustrated in Fig. 10 A, which shows a side-view of the frame 106cin the compressed state thereof, and in Fig. 10B, which shows a side-view of the frame 106cin an expanded state thereof, the circumferential distance between adjacent axial frame members 150cincreases with expansion, due to pivoting or angular movement of the strut pairs 111. However, since the inflow end 104 and outflow end 102 coincide with the ends of the axial frame members 150c, which do not change orientation during frame compression or expansion, the frame's height remains unchanged and equal to the length of the axial frame members 150c. This substantially eliminates valve foreshortening.

[0299] Stated otherwise, when the upper and lower ends of the axial frame members 150cdefine the outflow apices 116cand the inflow apices 118c, respectively, the height (or axial length) of the frame 106cis substantially equal to the unchanging length of the axial frame members 150c, irrespective of the state or diameter of the prosthetic valve. This can facilitate more accurate and / or predictable deployment of the prosthetic valve from the radially compressed state.

[0300] As shown in Fig. 9B, the frame 106coptionally comprises three stmt rungs 110 that define two cell rows 148 therebetween. Specifically, in the illustrated examples, frame 106cis shown to include a single intermediate rung 110S comprising a plurality of intermediate stmts 112, and no intermediate cell rows between the outflow cell row 1480 and inflow cell row 1481. Furthermore, cells 132care coupled to adjacent cells 132cwithin the same row via the axial frame members 150c, which extend between the outflow apices 116cand inflow apices 118c.

[0301] Each axial frame member 150ccan be comprised of axial segments 152c, wherein an axial segment 152cof an axial frame member 150cis defined as a portion of the corresponding axial frame member 150cextending between axially-adjacent joints 154 of the same axial frame member 150c. As detailed hereinabove, the inflow end 104 and outflow end 102, coincide with the ends of the axial frame members 150c.

[0302] In some examples, some of the proximal axial segments 152care commissure support axial members 142c. Commissure support axial members 142ccan optionally comprise a commissure window 146c, radially extending through the thickness of the commissure support axial member 142c, between two axially-extending sidewalls 147c. The commissure window 146ccan be configured to accept tabs 126 therein so as to couple the leaflet assembly 120 toAttorney Docket No: TH VVA- 13387 WO01 the frame 106c. In some examples, some of the proximal axial segments 152care non- commissural axial struts 117c.

[0303] While commissure support axial members 142athat include commissure windows 146aare illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support members configured to mount a commissure 130 in any other suitable manner, such as by supporting portions of the leaflet assembly 120 that can be wrapped therearound, or can include apertures through which sutures for attaching the commissures can be passed, and the like. Fig. 9C shows the frame 106cin a flat configuration for purposes of illustration.

[0304] Although the above algorithms have been described in relation to a non-foreshortening valve, this is not meant to be limiting in any way. The same algorithms related to nonforeshortening valves can be utilized in relation to other medical devices that do not exhibit foreshortening, including stents and catheters.

[0305] Figs. 11A and 11B show perspective and flattened views of a frame 106dof exemplary prosthetic valve 100d, illustrated without soft components such as leaflets or skirts for simplicity. Prosthetic valve 100dcan be structurally and functionally similar to any example of prosthetic valve 100cdescribed herein, except that the frame 106dof prosthetic valve 100dincludes at least two intermediate rungs 11 OS of stmts, namely a first intermediate rang 110S1 distal to the inflow rang 1101, and a second intermediate rang 110S2 proximal to the outflow rung 1120. Thus, frame 106ddefines a single intermediate cell row 148S between the outflow cell row 1480 and the inflow cell row 1481.

[0306] As detailed hereinabove, during expansion of prosthetic valve 100, or of another exemplary expandable prosthetic valve, a ratio of H / D is determined. The ratio of H / D can be compared to a stored group of known ratio values for prosthetic valve 100, corresponding to diameter values, such as in a look up table (LUT).

[0307] In some examples, an operator, such as a physician, may manually input details to user input terminal 268. Exemplary details may be type and / or size (e.g., representing a target expanded diameter of a range of expansion diameters) of a prosthetic valve to control unit 264, which are input at the start of a valve implantation procedure. In these examples, control unit 264 uses the inputted details to determine which set of known H / D ratio values the H / D ratio of the prosthetic valve of the procedure should be compared to.

[0308] In some examples, control unit 264 can be configured for automatic identification and validation of prosthetic valve type and size prior to execution of diameter measurement algorithms. The term "valve type identification," as used herein, refers to an automatedAttorney Docket No: TH VVA- 13387 WO01 determination of one or more specifications of prosthetic valve 100, such as manufacturer, model, and size category. In some examples, the stored H / D ratio values described above are different for each type of valve and for each size (corresponding to size ranges), thus it can be useful to identify the correct valve type and size automatically to prevent user input errors and ensure algorithm accuracy. In some examples, this can further prevent use of a program for inappropriate hardware.

[0309] In some examples, control unit 264 can comprise a valve identification module stored in memory 267 and executed by processors 265, the valve identification module configured to automatically detect valve specifications through multiple identification methodologies. Control unit 264 can further comprise a validation module stored in memory 267 and configured to verify valve compatibility and prevent processing of incompatible valve types.

[0310] In some examples, the valve identification module can implement fluoroscopic feature detection that leverages radiopaque markers and structural elements visible under fluoroscopy from imager 260. For example, US patent application publication 2025 / 0090312, published March 20, 2025, the entire contents of which are incorporated herein by reference, describes prosthetic valves with information indicators. US patent application publication 2017 / 0000603, published January 5, 2017, the entire contents of which are incorporated herein by reference, describes prosthetic valves with valve type indicators. US patent application publication 2021 / 0059814, published March 4, 2021, the entire contents of which are incorporated herein by reference, describes prosthetic valves with information markers.

[0311] Control unit 264 can identify any unique structural features formed as part of frame 106, can detect embedded or marked indicators on frame 106 or other valve components, can analyze radiopaque markers on delivery apparatus 202, and can process external identification markers placed within the imaging field. The term "radiopaque identification features," as used herein, refers to structural elements or markers that can be detected by control unit 264 in fluoroscopic images and provide valve specification information. In some examples, control unit 264 can store in memory 267 a comprehensive database of valve-specific identification patterns that correlate visual features with valve types and sizes. The valve identification module can compare detected features against this database using pattern recognition algorithms executed by processors 265.

[0312] In some examples, control unit 264 can identify structural features that are integrally formed as part of frame 106 and visible under fluoroscopy from imager 260. These features can include specific geometric patterns in frame design, unique strut configurations that indicate valve type, distinctive apex arrangements that correlate with valve specifications, andAttorney Docket No: TH VVA- 13387 WO01 purposely designed radiopaque elements that encode valve information using the information indicator methods described above. In some examples, the valve identification module can implement pattern recognition algorithms that analyze frame 106 geometry and compare detected patterns against known valve designs stored in memory 267. Control unit 264 can identify unique frame characteristics such as cell arrangements, strut patterns, overall frame geometry, and specialized features that distinguish different valve types and sizes.

[0313] In some examples, control unit 264 can identify markers positioned on delivery apparatus 202 components that indicate valve specifications. The valve identification module can detect markers on balloon catheter 210, can identify markings on nosecone 224 that provide greater area for identification features, can analyze existing delivery system markers such as central markers or valve positioning indicators, and can recognize specialized identification markers added specifically for automated valve detection. The term "delivery system identification markers," as used herein, refers to radiopaque elements positioned on delivery apparatus 202 that can be detected by control unit 264 and provide valve specification information.

[0314] In some examples, control unit 264 can utilize existing markers such as: a plurality of markers proximal to the valve area, as described below in relation to Figs. 21A - 21D; the shape characteristics of nosecone 224; central positioning markers; and other delivery system features that can be correlated with specific valve types. In some examples, control unit 264 can account for potential limitations of delivery system identification in cases where physicians may perform follow-up procedures using different balloon catheters. The validation module can recognize when delivery apparatus 202 markers are not detectable while prosthetic valve 100 itself remains identifiable through valve-integrated features.

[0315] In some examples, control unit 264 can implement external marker identification that utilizes separate identification elements placed within the fluoroscopic imaging field. The valve identification module can detect radiopaque stickers or markers placed on patient 252, can identify barcode-like markings visible under fluoroscopy, can analyze markers positioned on patient support platform 250 or covering materials, and can process identification elements placed anywhere between the radiation source and receptor of imager 260. In some examples, these markers can be placed over the chest of patient 252 (such as the sternum area), on sheets covering patient 252, beneath patient 252, beneath patient support platform 250, or in other locations where they remain visible to imager 260 during the procedure.

[0316] In some examples, control unit 264 can implement alternative identification methods that do not rely on fluoroscopic image analysis. The valve identification module can receiveAttorney Docket No: TH VVA- 13387 WO01 part number input through user input terminal 268. can process serial number information from valve packaging, can access valve specifications through barcode scanning interfaces, and can retrieve valve details from electronic records or databases stored in memory 267. In some examples, control unit 264 can maintain a comprehensive database in memory 267 that correlates part numbers and serial numbers with valve specifications, H / D ratio parameters, and measurement algorithm settings.

[0317] In some examples, the validation module can implement comprehensive valve compatibility verification executed by processors 265. The term "valve compatibility validation," as used herein, refers to the verification process where control unit 264 confirms that prosthetic valve 100 is suitable for processing with the available measurement algorithms. In some examples, control unit 264 can store compatibility matrices in memory 267 that define which valve types can be processed with specific algorithm versions, measurement parameters, and procedural protocols.

[0318] In some examples, control unit 264 can implement automatic algorithm configuration based on valve identification results. The validation module can select appropriate H / D ratio databases from memory 267, can configure measurement parameters specific to the identified valve type, and can optimize neural network settings for valve-specific characteristics. In some examples, control unit 264 can implement identification protocols that occur at procedure initiation rather than during ongoing measurements. The valve identification module can perform complete valve identification during initial imaging setup, can store identification results in memory 267 for consistent use throughout the procedure, can prevent accidental algorithm interraption once valve type is confirmed, and can provide clear validation status on user output terminal 266.

[0319] In some examples, the validation module can implement comprehensive error prevention measures. Control unit 264 can prompt appropriate messages on user output terminal 266 when valve identification fails, can refuse to initiate diameter measurement algorithms when valve type is invalid or unrecognized, can provide clear feedback regarding identification status and algorithm readiness, and can prevent processing with incorrect valve parameters that could compromise measurement accuracy.

[0320] In some examples, control unit 264 can implement combined identification methodologies that utilize multiple detection approaches for enhanced reliability. The valve identification module can combine fluoroscopic feature detection with part number validation, can cross-reference delivery system markers with valve-integrated features, can use external markers as backup identification when primary methods are unclear, and can provideAttorney Docket No: TH VVA- 13387 WO01 confidence scoring for identification results displayed on user output terminal 266. The term "multi-modal valve identification," as used herein, refers to the combined use of multiple identification approaches by control unit 264 to achieve robust and reliable valve specification determination. In some examples, control unit 264 can store confidence thresholds in memory 267 and require minimum confidence levels before proceeding with diameter measurement algorithms. This comprehensive identification and validation system enhances the reliability and safety of the real-time diameter measurement systems described above by ensuring correct valve parameters are used, preventing algorithm application to incompatible valve types, and reducing the potential for user input errors that could compromise measurement accuracy and procedural guidance.

[0321] Accordingly, disclosed herein are information indicators, which may be included in a variety of suitable locations. Suitable locations may be within exemplary prosthetic valves disclosed herein and / or in delivery apparatuses therefor, or within a kit that includes a prosthetic valve as disclosed herein. The information indicators may be used for automatic determination of details of prosthetic valves by control unit 264, based on images taken by imager 260. Any information indicator disclosed herein may indicate one of or a combination of details such as a manufacturer, a prosthetic valve type, a model number, and / or a valve size. These details are non-limiting and in other examples, other details may be indicated by the information indicator.

[0322] In some examples, a single information indicator may be included in a suitable location as disclosed herein. In some examples, a plurality of information indicators may be included in a suitable location as disclosed herein. In some examples, the information indicator may comprise alphanumeric characters, symbols, or other geometric shapes, or combinations thereof. In some examples, the information indicator may comprise barcode / s, QR code / s, serial number / s, part number / s and / or similar kinds of identifier. Any information indicator disclosed herein can comprise a radiopaque material, such as one or more of: tantalum, iodine, barium, barium sulfate, tantalum, bismuth, gold, or any other suitable radiopaque material.

[0323] Fig. 12 shows an exemplary prosthetic valve 100e. Prosthetic valve 100ecan be structurally and functionally similar to any example of prosthetic valve 100 disclosed herein, except that the outer skirt 170 comprises an exemplary information indicator 160a. Information indicator 160a is shown to be an imprint, which in some examples may comprise a radiopaque dye. "Imprint" as used herein, refers to any mark or design which is formed on a surface of a component, including but not limited to marks or designs created by printing, engraving,Attorney Docket No: TH VVA- 13387 WO01 etching, coating, stamping, or any other surface altering technique detectable by imaging techniques or by the human eye.

[0324] In some examples, information identifier 160a may be formed within a separate radiopaque component which is coupled to outer skirt 170 using sutures, and / or adhesives and / or any other suitable means of coupling. In the illustrated example, information indicator 160a is in the form of numeric characters '23'. In some examples, this may indicate a target diameter of prosthetic valve 100e. In some examples, another detail or multiple details may be indicated by information indicator 160a. In further examples, information indicator 160a may comprise other alphanumeric characters, symbols, or other geometric shapes or other types of identifier as detailed hereinabove, or combinations thereof.

[0325] Figs. 13A and 13B show side views of an exemplary prosthetic valve 100f, with and without soft components (such as skirts or the leaflet assembly), respectively. Prosthetic valve 100fis an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that outflow apices 116fand / or inflow apices 118fof a frame 106fthereof, comprise apex regions 158. Each apex region 158 can comprise a vertex 156fand two thinned (or narrowed) stmt portions 113, one thinned stmt portion 113 extending from either side of the vertex 156fto a corresponding, wider, outflow angled stmt 1080 (at the outflow end 102) or inflow angled stmt 1081 (at the inflow end 104). In this way, each of the apex regions 158 at the outflow end 102 can form a narrowed transition region between and relative to the two outflow angled stmts 1080 extending from the corresponding apex region 158 and each of the apex regions 158 at the inflow end 104 can form a narrowed transition region between and relative to the two inflow angled stmts 1081 extending from the corresponding apex region 158.

[0326] The frame 106ffurther comprises a plurality of proximal axial frame members 134f, arranged circumferentially at outflow end 102, and axially extending between junctions 1 14 of outflow mng 110O and junctions 114 of intermediate mng 110S, as shown in Figs 13A-13B. Proximal axial frame members 134fcan be similar to any exemplary proximal axial frame members 134athat are included in frame 106a.

[0327] Figs 14A shows a side-view of an exemplary prosthetic valve 100s. Prosthetic valve 100gis an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that prosthetic valve 100ffurther includes a radiopaque information indicator 160b attached to a commissure 130 thereof. Fig. 14B shows a detailed view of radiopaque information indicator 160b. In some examples, as shown in Figs. 14A and 14B, a radiopaque information indicatorAttorney Docket No: TH VVA- 13387 WO01160b can be attached (e.g., sutured) to an outer surface (a radially outward facing surface) of the commissure 130 such that the radiopaque information indicator 160b is exposed. In some examples, a piece of fabric or other flexible member can be secured to the commissure 130 and may cover all or a portion of the radiopaque information indicator 160b.

[0328] While only one radiopaque information indicator 160b is visible in Figs.l4A and 14B, it should be noted that one or more of the commissures 130 can include a radiopaque information indicator 160b attached thereto. For example, in some cases, an information indicator 160b can be secured to each commissure 130 of the prosthetic valve 100g. In some examples, an information indicator 160b may only be attached to some but not all of the commissures 130. In some examples, a plurality of information indicators 160b may be attached to a commissure 130 or a plurality of commissures 130.

[0329] Figs. 15A and 15B show side views of an exemplary prosthetic valve 100h, illustrated without soft components (such as skirts or the leaflet assembly) for clarity. Prosthetic valve 100his an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that prosthetic valve 100hfurther includes an information indicator 160c, formed of opening / s passing through the thickness of one or more of axial frame members 150h. The openings may be formed as part of frame 106h, which as disclosed hereinabove, may be formed by processes such as laser cutting, electroforming, and / or physical vapor deposition. In the illustrated examples of Fig 15 A and 15B, information indicators 160c are shown to be formed of openings passing through the thicknesses of non-commissural axial struts 1 17h. In Fig. 15A, an information indicator 160c is shown to be included in a single non-commissural axial strut 117h, while in Fig. 15B information indicators 160c are shown to be included in a plurality of non-commissural axial struts 117h. The openings may be formed at any location along the lengths of axial frame members 15011. In some examples, information indicators 160c may be formed of openings passing through the thicknesses of commissure support axial members 142h, either above or below commissure windows 146h. In the illustrated examples, a maximum of one information indicator 160c is shown to be formed within an axial frame member 150h. In some examples, a plurality of information indicators 160c may be included in an axial frame member 150hor in a plurality of axial frame members 150h. In some examples, information indicator 160c may be included in an angled stmt 108, at any location along any angled stmt 108. In some examples, a plurality of information indicators 160c may be included in an angled stmt 108 or in a plurality of angled stmts 108.Attorney Docket No: TH VVA- 13387 WO01

[0330] In some examples, a widened portion 166hmay be formed at a location along a length of an axial frame member 150h, and information indicators 160c may be formed of openings passing through a thickness thereof. Fig 16A shows a side-view of exemplary prosthetic valve 100hwith an axial frame member 150hcomprising a widened portion 166hwhich comprises an information indicator 160c. Fig. 16B shows a detailed view of widened portion 166h, comprising an information indicator 160c.

[0331] Advantageously, a widened portion 166hprovides more space for formation of an opening defining an information indicator 160c or a plurality of information indicators 160c. Accordingly, Figs. 16A and 16B show an information indicator 160c comprising multiple characters. However, it is to be understood that this is illustrative and any informational indicator disclosed herein may comprise any number of characters, symbols or other types of identifiers as detailed hereinabove, or combinations thereof. In some examples, widened portions 166hmay be included in a plurality of axial frame members 150h. In some examples, a plurality of widened portions 166hcomprising information indicator 160c may be formed along a length of an axial frame member 150h, or over lengths of a plurality of axial frame members 15011. In some examples, information indicator 160c may be included in an angled strut 108, at any location along any angled strut 108. In some examples, information indicators 160c may be included in a plurality of angled struts 108. In some examples, a plurality of information indicators 160c may be included in an angled strut 108 or in a plurality of angled struts 108.

[0332] Fig. 17A shows a side view of an exemplary prosthetic valve 1001, illustrated without soft components (such as skirts or the valvular structure) for clarity. Prosthetic valve 1001is an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that prosthetic valve 1001further includes axial frame members 1501which comprise externally formed information indicators 160d. "Externally formed" as used herein, refers to an information indicator formed not by openings passing through material, but by absence of material from around the perimeter of the information indicator shape.

[0333] Fig. 17B shows a detailed view of externally formed information indicator 160d. Externally formed information indicator 160d is illustratively shown to be included in a commissure support axial member 1421. Externally formed information indicator 160d is shown to extend proximally from a junction 114 of the intermediate rung 110S adjacent to the outflow cell row 1480, to abut a lower portion of commissure window 1461. An intersecting pair of struts 1111is shown to extend distally from information indicator 160d. ExternallyAttorney Docket No: TH VVA- 13387 WO01 formed information indicator 160d is shown to have a width equal to that of the commissure support axial member 1421, such that information indicator 160d is flush with axially-extending sidewalls 1471.

[0334] In some examples, such as the illustrated example of Fig. 18, externally formed information indicator 160d may be formed within a non-commissural axial strut 1121. Furthermore, as further shown in Fig. 18, externally formed information indicator 160d may have a width W2, that is greater than a width W1 of the non-commissural axial strut 1121. In some examples, externally formed information indicator 160d may have a width W2, that is less than a width W1 of the non-commissural axial stmt 1121. It is understood that these width variations may similarly apply to externally formed infomration indicators 160d included in any axial frame member 1501. In some examples, an externally formed information indicator 160d may be thinner than an axial frame member 1501. In some examples, an externally formed information indicator 160d may be thinner than an axial frame member 1501, such that one side of information indicator 160d is flush with one side of an axial frame member 1501, while the other side of information indicator 160d is recessed within axial frame member 1501.

[0335] In some examples, such as the illustrated example of Fig. 18, externally formed information indicator 160d is shown to extend distally from a junction 114 of the outflow rung 1100. An intersecting pair of struts 1111are shown to extend proximally from infomration indicator 160d in the illustrated example of Fig. 18. In some examples, externally formed information indicator 160d may be formed at any location along the length of an axial frame member 1501, and may extend from any junction 114 of any rung 110. In some examples, as shown in Fig. 19, a plurality of axial frame members 1501may each comprise an externally formed information indicator 160d. In some examples, infomation indicator 160d may be included in an angled strut 108, at any location along any angled strut 108. In some examples, information indicators 160d may be included in a plurality of angled struts 108. In some examples, a plurality of information indicators 160d may be included in an angled strut 108 or in a plurality of angled struts 108.

[0336] Figure 20A shows a side view of an exemplary prosthetic valve 100’. Prosthetic valve 100* is an exemplary implementation of a prosthetic valve 100, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that prosthetic valve 100' includes no axial frame members, and the frame is configured to support a leaflet assembly 120 attached thereto via commissure support members 162 coupled to commissure cells 164 thereof. Leaflet assembly 120 may be coupled to commissure support members 162 by any suitable means such as sutures and the like.Attorney Docket No: TH VVA- 13387 WO01

[0337] Commissure cells 164 are diamond shaped cells, each comprised of four angled stmts 108. Each commissure support member 162 can be made of relatively flexible and soft material or materials, including synthetic materials (e.g., PET fabric) or natural tissue (e.g. bovine pericardium). The number of commissure support members 162 can match the number of commissures 130, and the commissure support members 162 may be sutured to stmts of commissure cells 164 with sutures 163, or coupled thereto by any other suitable means.

[0338] As shown in Fig. 20A, and in greater detail in the detailed view of Fig. 20B, a commissure support member 162 may comprise an exemplary information indicator 160e. Information indicator 160e is shown to be an imprint, which in some examples may comprise a radiopaque dye. In some examples, infomration identifier 160e may be formed within a separate radiopaque component which is coupled to a commissure support member 162 using sutures, and / or adhesives and / or any other suitable means of coupling. In some examples, a commissure support member 162 may comprise a single information indicator 160e. In some examples, a commissure support member 162 may comprise a plurality of information indicators 160e. In some examples, a plurality of commissure support members 162 may comprise a single information indicator 160e or a plurality of information indicators 160e.

[0339] In some examples, an information indicator may be included in delivery apparatus 202, as disclosed hereinabove. Fig. 21 shows a fluoroscopic image of a guidewire 212, extending through a distal end portion of delivery apparatus 202, with an information indicator 160f arranged on or embedded within nosecone 224 of the delivery apparatus in a manner that is aligned with (e.g., overlapping) the guidewire 212.

[0340] In some examples, information indicator 160f may be included at a location along delivery shaft 208. In some examples, infonnation indicator 160f may be included in nosecone 224 in a manner that is not aligned with the guidewire 212. In some examples, information indicator 160f may be included elsewhere in nosecone 224. Advantageously, nosecone 224 has a relatively large amount of space to include information indicator 160f therein or thereupon. In some examples, information indicator 160f may be included at any suitable location within delivery apparatus 202. In further examples, information indicator 160f may be internally or externally formed. For example, the nosecone 224 may be shaped to function as an exemplary information indicator 160f. In some examples, information indicator 160f may be formed within a separate radiopaque component that is coupled to a suitable location within delivery apparatus 202, either permanently or removably. In some examples, information indicator 160f may be integrally formed with delivery apparatus 202.Attorney Docket No: TH VVA- 13387 WO01

[0341] While the illustrated examples of Fig. 21 shows information indicator 160f as comprising alphanumeric characters, in some examples, information indicator 160f may comprise other kinds of identifier. In Fig. 22 A, an exemplary information indicator 160f is shown to comprise a barcode-like marking, arranged over a distal end portion of delivery apparatus 202 in a manner that is aligned with the guidewire 212. It is understood that this location is illustrative and other suitable locations within delivery apparatus 202 may be contemplated, as detailed hereinabove.

[0342] Figs. 22B, 22C and 22D show examples in which information indicator 160f comprises a series of marks, which are illustrated as dots. In some examples, the marks may comprise other symbols, such as bands or lines and the like. The arrangements of the series of marks can convey information. For example, there are three dots in Fig. 22B, which are arranged with uniform spacing therebetween. This may indicate a specific size of prosthetic valve 100. A series of three dots arranged with non-uniform spacing therebetween shown in Fig. 22C may indicate a different size of prosthetic valve 100. The arrangement of two dots in a corresponding location of delivery apparatus 202 illustrated in Fig. 22D may indicate yet another size of prosthetic valve 100. Alternatively, in some examples, the arrangements of the series of dots may indicate other types of information as detailed hereinabove.

[0343] In some examples, such as the illustrated example of Fig. 22D, there may be a plurality of arrangements of the series of dots or other symbols, disposed at different locations within delivery apparatus 202. In the illustrated example of Fig. 22D, two arrangements of series of dots are axially offset from one another along a distal end portion of delivery apparatus 202, in a manner that is aligned with the guidewire 212. In some examples, each arrangement may indicate a different type of information. For example, one arrangement may indicate a type of prosthetic valve 100 while another may indicate a size of prosthetic valve 100. It is understood that these types of information are optional and other types of information may be indicated by a plurality of arrangements of marks.

[0344] In some examples, a plurality of arrangements of series of marks may indicate a single type of information, or a single arrangement may indicate a plurality of types of information. In some examples, differing sizes of marks within an arrangement, such as the varying widths of lines in the barcode -like marking of Fig. 22A, may indicate types of information. In some examples, an arrangement of marks may comprise a plurality of different types of symbols, for example a dot and a line or a plurality of dots of lines, with each type of symbol indicating a type of information. Any number of combinations of types of symbols may be contemplated.Attorney Docket No: TH VVA- 13387 WO01

[0345] In some examples, it is desirable to include information indicator 160f at a location within delivery apparatus 202 which is not concealed by prosthetic valve 100 when crimped over delivery apparatus 202, since such concealment may prevent detection of information indicator 160f by imager 260. As detailed hereinabove, in the illustrated example of Fig. 22D, two arrangements of series of dots are axially offset from one another along a distal end portion of delivery apparatus 202. In this example, a first arrangement may be distal to a crimped prosthetic valve 100, while a second arrangement may be proximal to a crimped prosthetic valve 100, thereby avoiding concealment. In some examples, information indicator 160f may be included in a location such as nosecone 224 which is comparatively distant from a location where prosthetic valve 100 may be crimped over delivery apparatus 202, thereby obviating the possibility of information indicator 160f being concealed by prosthetic valve 100.

[0346] Fig. 23 shows a side view of an exemplary prosthetic valve 100k, illustrated without soft components (such as skirts or the valvular structure) for clarity. Prosthetic valve 100kis an exemplary implementation of a prosthetic valve 100 and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that prosthetic valve 100kfurther includes one or more information indicators 160g. Information indicators 160g extend proximally or substantially proximally from junctions 114 at the outflow end 102 of the frame. For example, an information indicator 160g can be generally continuous with a corresponding axial frame member 150sfrom which it extends.

[0347] In some examples, a plurality of axial frame members 150smay comprise an information indicator 160g, or a plurality of information indicators 160g. In some examples, information indicator 160g may comprise a distal support portion 168 extending from vertices 156g. In some examples, information indicator 160g may extend from vertices 156gwithout a distal support portion. In some examples, information indicator 160g may extend distally or substantially distally from vertices 156sat the inflow end 104. In some examples, information indicator 160g may extend laterally or substantially laterally from any junction 114 included in a frame 106.

[0348] In some examples, an information indicator 160 (such as any of information indicators 160a - 160g) may be provided on a sticker which may be attached at any suitable location on exemplary prosthetic valves disclosed herein and / or in delivery apparatuses therefor. Furthermore, a sticker comprising an information indicator 160 (such any of information indicators 160a - 160g) may be placed at a suitable location on patient 252, such as over the patient's chest in some examples. In some examples, a sticker comprising an information indicator 160 (such as any of information indicators 160a - 160g) may be placed a locationAttorney Docket No: TH VVA- 13387 WO01 within the exemplary setup for patient 252 undergoing implantation of prosthetic valve 100. In some examples, the sticker may be placed on patient support platform 250. In some examples, the sticker may be placed on sheets which cover patient 252. In further examples, the sticker may be placed at any location within the setup which can be imaged by imager 260.Some Examples of the Disclosed Technology

[0349] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0350] Example 1. A method of determining an expected expansion diameter of an expandable medical device, the method comprising: receiving one or more images showing the medical device being expanded; for each of the received one or more images, identifying one or more features of the medical device; for each of the received one or more images, based at least in part on the identified one or more features, determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken; based at least in part on the determined image diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the imaging time; and for at least one of the one or more images, outputting information regarding the determined expected expansion diameter of the medical device.

[0351] Example 2. The method of any example herein, particularly example 1, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0352] Example 3. The method of any example herein, particularly example 1, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0353] Example 4. The method of any example herein, particularly any one of examples 1 - 3, wherein the received one or more images comprises a series of fluoroscopic images.

[0354] Example 5. The method of any example herein, particularly example 4, wherein the information regarding the determined expected expansion diameter of the medical device is output for each of the series of fluoroscopic images.Attorney Docket No: TH VVA- 13387 WO01

[0355] Example 6. The method of any example herein, particularly any one of examples 1 - 5, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining an orientation of the medical device within the respective image.

[0356] Example 7. The method of any example herein, particularly any one of examples 1 - 6, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining a height of the medical device.

[0357] Example 8. The method of any example herein, particularly example 7, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining a ratio between the height and diameter of the medical device.

[0358] Example 9. The method of any example herein, particularly example 8, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises identifying a plurality of points on the medical device, wherein the ratio is determined based at least in part on the identified points.

[0359] Example 10. The method of any example herein, particularly example 9, wherein, for each of the one or more images, the identification of the plurality of points on the medical device is performed utilizing a neural network.

[0360] Example 11. The method of any example herein, particularly any one of examples 7 -10, wherein, for each of the one or more images, the determination of the height of the medical device comprises determining a length of a curved edge of the medical device within the respective image.

[0361] Example 12. The method of any example herein, particularly any one of examples 1 -11 , further comprising : receiving a respective user input indicating a target expansion diameter for the medical device; for each of the one or more images, comparing the determined expected expansion diameter of the medical device to the target expansion diameter; and for each of the one or more images, outputting an indication of an outcome of the comparison.

[0362] Example 13. The method of any example herein, particularly any one of examples 1 -12, further comprising receiving a respective user input indicating a type of the medical device, wherein the one or more recoil values are based at least in part on the type of the medical device.

[0363] Example 14. The method of any example herein, particularly any one of examples 1 -13, further comprising: comparing the determined expected expansion diameter to a respective threshold; and based at least in part on an outcome of the comparison to the respective threshold, ceasing the expansion of the medical device.Attorney Docket No: TH VVA- 13387 WO01

[0364] Example 15. The method of any example herein, particularly example 14, wherein the medical device is a balloon expandable valve, and wherein the ceasing of the expansion of the medical device comprising controlling a pump to stop pumping inflation fluid into a balloon that is expanding the medical device.

[0365] Example 16. A method of determining an expected expansion diameter of an expandable medical device during expansion thereof, the method comprising: during the expansion of the medical device, receiving one or more sets of signals associated with the medical device; for each of the received one or more sets of signals, determining a signal diameter of the medical device, the signal diameter being the diameter of the medical device at a sampling time when the set of signals was generated; based at least in part on the determined signal diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the sampling time; and for at least one of the one or more sets of signals, outputting information regarding the determined expected expansion diameter of the medical device.

[0366] Example 17. The method of any example herein, particularly example 16, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0367] Example 18. The method of any example herein, particularly example 16, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0368] Example 19. The method of any example herein, particularly any one of examples 16 - 18, wherein the one or more sets of signals comprises a plurality of sets of signals, each set received at a different point in time, the method further comprising: receiving a respective user input indicating a target expansion diameter for the medical device; for each of the received one or more sets of signals, comparing the determined expected expansion diameter of the medical device to the target expansion diameter; and for each of the received one or more sets of signals, outputting an indication of an outcome of the comparison.

[0369] Example 20. The method of any example herein, particularly any one of examples 16 - 19, further comprising receiving a respective user input indicating a type of the medical device, wherein the one or more recoil values are based at least in part on the type of the medical device.

[0370] Example 21. The method of any example herein, particularly any one of examples 16 - 20, further comprising: comparing the determined expected expansion diameter to aAttorney Docket No: TH VVA- 13387 WO01 respective threshold; and based at least in part on an outcome of the comparison to the respective threshold, ceasing the expansion of the medical device.

[0371] Example 22. The method of any example herein, particularly example 21, wherein the medical device is a balloon expandable valve, and wherein the ceasing of the expansion of the medical device comprising controlling a pump to stop pumping inflation fluid into a balloon that is expanding the medical device.

[0372] Example 23. A method of ovality determination in an expandable medical device, the method comprising: receiving an expansion image showing the medical device being expanded; receiving an implant image showing the medical device after recoil; for each of the received images, identifying one or more features of the medical device; based at least in part on the identified one or more features of the medical device in the expansion image, determining a pre-recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at an imaging time when the expansion image was taken; based at least in part on the identified one or more features of the medical device in the implant image, determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at an imaging time when the implant image was taken; based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoil values, determining whether the implanted medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0373] Example 24. The method of any example herein, particularly example 23, further comprising, based at least in part on the determined expected expansion diameter of the medical device and the determined post-recoil diameter of the medical device, determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0374] Example 25. The method of any example herein, particularly example 23 or 24, wherein each of the pre-recoil diameter and the post-recoil diameter is determined at a plurality of heights of the medical device, and wherein the method further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.

[0375] Example 26. The method of any example herein, particularly any one of examples 23 - 25, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.Attorney Docket No: TH VVA- 13387 WO01

[0376] Example 27. The method of any example herein, particularly any one of examples 23 - 25, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0377] Example 28. A method of ovality determination in an expandable medical device, the method comprising: during expansion of the medical device, receiving a first set of signals associated with the medical device; after the expansion of the medical device, receiving a second set of signals associated with the medical device; based at least in part on the received first set of signals, determining a pre-recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at a first sampling time when the first set of signals was generated; based at least in part on the received second set of signals, determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at a second sampling time when the second set of signals was generated; based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoil values, determining whether the expanded medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0378] Example 29. The method of any example herein, particularly example 28, further comprising, based at least in part on the determined pre-recoil diameter of the medical device and the determined post-recoil diameter of the medical device, determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0379] Example 30. The method of any example herein, particularly example 28 or 29, wherein each of the pre-recoil diameter and the post-recoil diameter is determined at a plurality of heights of the medical device, and wherein the method further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.

[0380] Example 31. The method of any example herein, particularly any one of examples 28 - 30, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0381] Example 32. The method of any example herein, particularly any one of examples 28 - 30, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0382] Example 33. A method of ovality determination in a medical device, the method comprising: receiving a plurality of images showing the medical device, each of the plurality of images taken at a different orientation; for each of the received images, identifying one orAttorney Docket No: TH VVA- 13387 WO01 more features of the medical device; for each of the received images, based at least in part on the identified one or more features of the medical device in the respective image, determining one or more diameters of the medical device; based at least in part on the determined diameters, determining whether the medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0383] Example 34. The method of any example herein, particularly example 33, further comprising, based at least in part on the determined diameters, determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0384] Example 35. The method of any example herein, particularly example 33 or 34, wherein for each of the plurality of images, the one or more diameters comprises a plurality of diameters, each determined at a respective one of a plurality of heights of the medical device, and wherein the method further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.

[0385] Example 36. A method of determining a height variance in an expandable medical device, the method comprising; receiving a 2-dimensional image showing the medical device in an expanded state in an image plane; identifying within the image a plurality of axial frame members of the medical device; measuring a length of each of the plurality of identified axial frame members; based at least in part on the measured lengths, determining a position of each of the plurality of axial frame members in relation to the image plane; based at least in part on the determining positions of the plurality of axial frame members, determining a plurality of heights of the medical device; based at least in part on the determined heights of the medical device, determining a height variance in the medical device; and outputting information regarding the determined height variance.

[0386] Example 37. The method of any example herein, particularly example 36, further comprising determining an orientation of the medical device within the image, wherein the determination of the plurality of heights is based at least in part on the determined orientation.

[0387] Example 38. The method of any example herein, particularly example 36 or 37, wherein the determination of the height variance comprises determining that a height variance is present.

[0388] Example 39. The method of any example herein, particularly example 36 or 37, wherein the determination of the height variance comprises determining an amount of height variance present.Attorney Docket No: TH VVA- 13387 WO01

[0389] Example 40. A method of determining a regional under-expansion of an expandable medical device, the method comprising: receiving a 2-dimensional image showing the medical device in an expanded state in an image plane; identifying within the image a plurality of axial frame members of the medical device; measuring a length of each of the plurality of identified axial frame members; based at least in part on the measured lengths, determining a position of each of the plurality of axial frame members in relation to the image plane; based at least in part on the determining positions of the plurality of axial frame members, determining a plurality of arclengths extending between the identified axial frame members; based at least in part on the determined arclengths, determining a regional under-expansion of the medical device; and outputting information regarding the determined regional under-expansion.

[0390] Example 41. The method of any example herein, particularly example 40, wherein the determination of the regional under-expansion comprises determining that a regional underexpansion is present.

[0391] Example 42. The method of any example herein, particularly example 40, wherein the determination of the regional under-expansion comprises determining an amount of regional under-expansion present.

[0392] Example 43. A system for determining an expected expansion diameter of an expandable medical device, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving one or more images showing the medical device being expanded; for each of the received one or more images, identifying one or more features of the medical device; for each of the received one or more images, based at least in part on the identified one or more features, determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken; based at least in part on the determined image diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the imaging time; and for at least one of the one or more images, outputting information regarding the determined expected expansion diameter of the medical device.

[0393] Example 44. The system of any example herein, particularly example 43, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.Attorney Docket No: TH VVA- 13387 WO01

[0394] Example 45. The system of any example herein, particularly example 43, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0395] Example 46. The system of any example herein, particularly any one of examples 43 - 45, wherein the received one or more images comprises a series of fluoroscopic images.

[0396] Example 47. The system of any example herein, particularly example 46, wherein the information regarding the determined expected expansion diameter of the medical device is output for each of the series of fluoroscopic images.

[0397] Example 48. The system of any example herein, particularly any one of examples 43 -47, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining an orientation of the medical device within the respective image.

[0398] Example 49. The system of any example herein, particularly any one of examples 43 -48, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining a height of the medical device.

[0399] Example 50. The system of any example herein, particularly example 49, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises determining a ratio between the height and diameter of the medical device.

[0400] Example 51. The system of any example herein, particularly example 50, wherein, for each of the one or more images, the identification of one or more features of the medical device comprises identifying a plurality of points on the medical device, wherein the ratio is determined based at least in part on the identified points.

[0401] Example 52. The system of any example herein, particularly example 51, wherein, for each of the one or more images, the identification of the plurality of points on the medical device is performed utilizing a neural network.

[0402] Example 53. The system of any example herein, particularly any one of examples 49 -52, wherein, for each of the one or more images, the determination of the height of the medical device comprises determining a length of a curved edge of the medical device within the respective image.

[0403] Example 54. The system of any example herein, particularly any one of examples 43 -53, wherein the plurality of steps further comprises: receiving a respective user input indicating a target expansion diameter for the medical device; for each of the one or more images, comparing the determined expected expansion diameter of the medical device to the targetAttorney Docket No: TH VVA- 13387 WO01 expansion diameter; and for each of the one or more images, outputting an indication of an outcome of the comparison.

[0404] Example 55. The system of any example herein, particularly any one of examples 43 -54, further comprising receiving a respective user input indicating a type of the medical device, wherein the one or more recoil values are based at least in part on the type of the medical device.

[0405] Example 56. The system of any example herein, particularly any one of examples 43 -55, wherein the plurality of steps further comprises: comparing the determined expected expansion diameter to a respective threshold; and based at least in part on an outcome of the comparison to the respective threshold, ceasing the expansion of the medical device.

[0406] Example 57. The system of any example herein, particularly example 56, wherein the medical device is a balloon expandable medical device, and wherein the ceasing of the expansion of the medical device comprising controlling a pump to stop pumping inflation fluid into a balloon that is expanding the medical device.

[0407] Example 58. A system of determining an expected expansion diameter of an expandable medical device during expansion thereof, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: during the expansion of the medical device, receiving one or more sets of signals associated with the medical device; for each of the received one or more sets of signals, determining a signal diameter of the medical device, the signal diameter being the diameter of the medical device at a sampling time when the set of signals was generated; based at least in part on the determined signal diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the sampling time; and for at least one of the one or more sets of signals, outputting information regarding the determined expected expansion diameter of the medical device.

[0408] Example 59. The system of any example herein, particularly example 58, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0409] Example 60. The system of any example herein, particularly example 58, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.Attorney Docket No: TH VVA- 13387 WO01

[0410] Example 61. The system of any example herein, particularly any one of examples 58 -60, wherein the one or more sets of signals comprises a plurality of sets of signals, each set received at a different point in time, the plurality of steps further comprising: receiving a respective user input indicating a target expansion diameter for the medical device; for each of the received one or more sets of signals, comparing the determined expected expansion diameter of the medical device to the target expansion diameter; and for each of the received one or more sets of signals, outputting an indication of an outcome of the comparison.

[0411] Example 62. The system of any example herein, particularly any one of examples 58 -61, wherein the plurality of steps further comprises receiving a respective user input indicating a type of the medical device, wherein the one or more recoil values are based at least in part on the type of the medical device.

[0412] Example 63. The system of any example herein, particularly any one of examples 58 -62, wherein the plurality of steps further comprises: comparing the determined expected expansion diameter to a respective threshold; and based at least in part on an outcome of the comparison to the respective threshold, ceasing the expansion of the medical device.

[0413] Example 64. The system of any example herein, particularly example 63, wherein the medical device is a balloon expandable medical device, and wherein the ceasing of the expansion of the medical device comprising controlling a pump to stop pumping inflation fluid into a balloon that is expanding the medical device.

[0414] Example 65. A system of ovality determination in an expandable medical device, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving an expansion image showing the medical device being expanded; receiving an implant image showing the expanded medical device after recoil; for each of the received images, identifying one or more features of the medical device; based at least in part on the identified one or more features of the medical device in the expansion image, determining a pre-recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at an imaging time when the expansion image was taken; based at least in part on the identified one or more features of the medical device in the implant image, determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at an imaging time when the implant image was taken; based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoilAttorney Docket No: TH VVA- 13387 WO01 values, determining whether the expanded medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0415] Example 66. The system of any example herein, particularly example 65, further comprising, based at least in part on the determined expected expansion diameter of the medical device and the determined post-recoil diameter of the medical device, determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0416] Example 67. The system of any example herein, particularly example 65 or 66, wherein each of the pre -recoil diameter and the post-recoil diameter is determined at a plurality of heights of the medical device, and wherein the plurality of steps further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.

[0417] Example 68. The system of any example herein, particularly any one of examples 65 - 67, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0418] Example 69. The system of any example herein, particularly any one of examples 65 - 67, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0419] Example 70. A system of ovality determination in an expandable medical device, the system comprising: during expansion of the medical device, receiving a first set of signals associated with the medical device; after the expansion of the medical device, receiving a second set of signals associated with the medical device; based at least in part on the received first set of signals, determining a pre -recoil diameter of the medical device, the pre-recoil diameter being the diameter of the medical device at a first sampling time when the first set of signals was generated; based at least in part on the received second set of signals, determining a post-recoil diameter of the medical device, the post-recoil diameter being the diameter of the medical device at a second sampling time when the second set of signals was generated; based at least in part on a difference between the determined pre-recoil diameter and the determined post-recoil diameter, and one or more recoil values, determining whether the expanded medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0420] Example 71. The system of any example herein, particularly example 70, wherein the plurality of steps further comprises, based at least in part on the determined pre-recoil diameter of the medical device and the determined post-recoil diameter of the medical device,Attorney Docket No: TH VVA- 13387 WO01 determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0421] Example 72. The system of any example herein, particularly example 70 or 71 , wherein each of the pre-recoil diameter and the post-recoil diameter is determined at a plurality of heights of the medical device, and wherein the plurality of steps further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.

[0422] Example 73. The system of any example herein, particularly any one of examples 70 - 72, wherein the one or more recoil values comprises an average of measured differences between a medical device diameter before recoil and after recoil.

[0423] Example 74. The system of any example herein, particularly any one of examples 70 - 72, wherein the one or more recoil values comprises a range of measured differences between a medical device diameter before recoil and after recoil.

[0424] Example 75. A system of ovality determination in a medical device, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving a plurality of images showing the medical device, each of the plurality of images taken at a different orientation; for each of the received images, identifying one or more features of the medical device; for each of the received images, based at least in part on the identified one or more features of the medical device in the respective image, determining a diameter of the medical device; based at least in part on the determined diameters, determining whether the medical device exhibits an ovality; and outputting information regarding the ovality determination.

[0425] Example 76. The system of any example herein, particularly example 75, wherein the plurality of steps further comprises, based at least in part on the determined diameters, determining an amount of the ovality of the medical device, wherein the output information comprises the determined amount of ovality of the medical device.

[0426] Example 77. The system of any example herein, particularly example 75 or 76, wherein for each of the plurality of images, the one or more diameters comprises a plurality of diameters, each determined at a respective one of a plurality of heights of the medical device, and wherein the plurality of steps further comprises identifying at which of the plurality of heights the ovality of the medical device is present, the output information regarding the identified height where the ovality of the medical device is present.Attorney Docket No: TH VVA- 13387 WO01

[0427] Example 78. A system of determining a height variance in an expandable medical device, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving a 2-dimensional image showing the medical device in an expanded state in an image plane; identifying within the image a plurality of axial frame members of the medical device; measuring a length of each of the plurality of identified axial frame members; based at least in part on the measured lengths, determining a position of each of the plurality of axial frame members in relation to the image plane; based at least in part on the determining positions of the plurality of axial frame members, determining a plurality of heights of the medical device; based at least in part on the determined heights of the medical device, determining a height variance in the medical device; and outputting information regarding the determined height variance.

[0428] Example 79. The system of any example herein, particularly example 78, further comprising determining an orientation of the medical device within the image, wherein the determination of the plurality of heights is based at least in part on the determined orientation.

[0429] Example 80. The system of any example herein, particularly example 78 or 79, wherein the determination of the height variance comprises determining that a height variance is present.

[0430] Example 81. The system of any example herein, particularly example 78 or 79, wherein the determination of the height variance comprises determining an amount of height variance present.

[0431] Example 82. A system of determining a regional under-expansion of an expandable medical device, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving a 2-dimensional image showing the medical device in an expanded state in an image plane; identifying within the image a plurality of axial frame members of the medical device; measuring a length of each of the plurality of identified axial frame members; based at least in part on the measured lengths, determining a position of each of the plurality of axial frame members in relation to the image plane; based at least in part on the determining positions of the plurality of axial frame members, determining a plurality of arclengths extending between the identified axial frame members; based at least in part on the determinedAttorney Docket No: TH VVA- 13387 WO01 arclengths, determining a regional under-expansion of the medical device; and outputting information regarding the determined regional under-expansion.

[0432] Example 83. The system of any example herein, particularly example 82, wherein the determination of the regional under-expansion comprises determining that a regional underexpansion is present.

[0433] Example 84. The system of any example herein, particularly example 82, wherein the determination of the regional under-expansion comprises determining an amount of regional under-expansion present.

[0434] Example 85. A method of determining a diameter of an expandable medical device during expansion thereof, the method comprising: receiving an image showing the medical device being expanded; utilizing a parameter identification neural network (NN) to identify within the received image a first plurality of parameters defining a respective ellipse at a first portion of the medical device; based at least in part on the identified first plurality of parameters, determining a diameter of the medical device; and outputting information regarding the determined diameter.

[0435] Example 86. The method of any example herein, particularly example 85, further comprising utilizing the parameter identification NN to identify within the received image a second plurality of parameters defining a respective ellipse at a second portion of the medical device, wherein the determination of the diameter of the medical device is based at least in part on the identified second plurality of parameters.

[0436] Example 87. The method of any example herein, particularly example 85 or 86, wherein the first plurality of parameters comprises a first plurality of points.

[0437] Example 88. The method of any example herein, particularly example 87, wherein the first plurality of points comprises 3 or 4 points.

[0438] Example 89. The method of any example herein, particularly example 87, wherein the first plurality of points consists essentially of 3 or 4 points.

[0439] Example 90. The method of any example herein, particularly any one of examples 85 - 89, further comprising, determining a height of the medical device within the received image, wherein the determination of the diameter of the medical device is based at least in part on the determined height.

[0440] Example 91. The method of any example herein, particularly example 90, further comprising, utilizing the parameter identification NN to identify within the received image a third set of points, the height determined based at least in part on the third set of points.Attorney Docket No: TH VVA- 13387 WO01

[0441] Example 92. The method of any example herein, particularly example 91, wherein the third set of points comprises a third plurality of points, the third plurality of points consisting essentially of 2 points.

[0442] Example 93. The method of any example herein, particularly example 92, wherein the third plurality of points are located between an inflow end and an outflow end of the medical device.

[0443] Example 94. The method of any example herein, particularly any one of examples 92- 93, wherein a first and second of the third plurality of points are on opposing sides of the medical device.

[0444] Example 95. The method of any example herein, particularly any one of examples 85- 94, wherein the parameter identification NN outputs a plurality of heatmaps, the method further comprising identifying the first plurality of parameters and second plurality of parameters within the output heatmaps.

[0445] Example 96. The method of any example herein, particularly any one of examples 85- 95, further comprising determining a ratio between the diameter and height of the medical device, the determination of the diameter being based at least in part on the determined ratio.

[0446] Example 97. The method of any example herein, particularly any one of examples 85- 96, further comprising utilizing a region of interest (ROI) neural network (NN) to define within the received image a region of interest comprising the medical device, wherein the identification of the first and second plurality of parameters is performed within the defined region of interest.

[0447] Example 98. The method of any example herein, particularly example 97, wherein the ROI NN determines an orientation of the medical device within the image, wherein the determination of the orientation of the medical device is based at least in part on a classification based technique defining a plurality of classes, each of the plurality of classes representing a respective angle.

[0448] Example 99. The method of any example herein, particularly example 98, wherein the classification based technique utilizes circular smooth label values.

[0449] Example 100. A system of determining a diameter of an expandable medical device during expansion thereof, the system comprising: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving an image showing the medical device being expanded; utilizing a parameter identification neural network (NN) to identify within the received image a firstAttorney Docket No: TH VYA- 13387 WO01 plurality of parameters defining a respective ellipse at a first portion of the medical device; based at least in part on the identified first plurality of parameters, determining a diameter of the medical device; and outputting information regarding the determined diameter.

[0450] Example 101. The system of any example herein, particularly example 100, further comprising utilizing the parameter identification NN to identify within the received image a second plurality of parameters defining a respective ellipse at a second portion of the medical device, wherein the determination of the diameter of the medical device is based at least in part on the identified second plurality of parameters.

[0451] Example 102. The system of any example herein, particularly example 100 or 101, wherein the first plurality of parameters comprises a first plurality of points.

[0452] Example 103. The system of any example herein, particularly example 102, wherein the first plurality of points comprises 3 or 4 points.

[0453] Example 104. The system of any example herein, particularly example 102, wherein the first plurality of points consists essentially of 3 or 4 points.

[0454] Example 105. The system of any example herein, particularly any one of examples 100- 104, wherein the plurality of steps further comprises, determining a height of the medical device within the received image, wherein the determination of the diameter of the medical device is based at least in part on the determined height.

[0455] Example 106. The system of any example herein, particularly example 105, wherein the plurality of steps further comprises utilizing the parameter identification NN to identify within the received image a third set of points, the height determined based at least in part on the third set of points.

[0456] Example 107. The system of any example herein, particularly example 106, wherein the third set of points comprises a third plurality of points, the third plurality of points consisting essentially of 2 points.

[0457] Example 108. The system of any example herein, particularly example 107, wherein the third plurality of points are located between an inflow end and an outflow end of the medical device.

[0458] Example 109. The system of any example herein, particularly any one of examples 107- 108, wherein a first and second of the third plurality of points are on opposing sides of the medical device.

[0459] Example 110. The system of any example herein, particularly any one of examples 100- 109, wherein the parameter identification NN outputs a plurality of heatmaps, the pluralityAttorney Docket No: TH VVA- 13387 WO01 of steps further comprising identifying the first plurality of parameters and second plurality of parameters within the output heatmaps.

[0460] Example 111. The system of any example herein, particularly any one of examples 100 - 110, wherein the plurality of steps further comprises determining a ratio between the diameter and height of the medical device, the determination of the diameter being based at least in part on the determined ratio.

[0461] Example 112. The system of any example herein, particularly any one of examples 100 - 1 11 , wherein the plurality of steps further comprises utilizing a region of interest (RO1) neural network (NN) to define within the received image a region of interest comprising the medical device, wherein the identification of the first and second plurality of parameters is performed within the defined region of interest.

[0462] Example 113. The system of any example herein, particularly example 112, wherein the ROI NN determines an orientation of the medical device within the image, wherein the determination of the orientation of the medical device is based at least in part on a classification based technique defining a plurality of classes, each of the plurality of classes representing a respective angle.

[0463] Example 114. The system of any example herein, particularly example 113, wherein the classification based technique utilizes circular smooth label values.

[0464] Example 115. A system for identifying spatial orientation of a medical device in fluoroscopic images, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving a plurality of sequential images showing a medical device frame; identifying a plurality of points on the medical device frame in each of the plurality of sequential images; measuring displacement of the plurality points between the sequential images; and classifying portions of the medical device frame as front or rear based at least in part on the measured displacements.

[0465] Example 116. The system of any example herein, particularly example 115, wherein the classification comprises determining that portions with larger displacements are closer to an imaging source.

[0466] Example 117. The system of any example herein, particularly any one of examples 115 - 116, wherein the identifying the plurality of points comprises identifying elliptical contours at inflow and outflow ends of the medical device frame.Attorney Docket No: TH VVA- 13387 WO01

[0467] Example 118. The system of any example herein, particularly example 117. wherein the plurality of points comprises points where a diameter of the respective elliptical contours intersects a perimeter of the respective ellipse.

[0468] Example 119. The system of any example herein, particularly example 118, wherein the measuring displacement comprises measuring distances relative to one or more axes of an elliptical contour of the medical device frame.

[0469] Example 120. The system of any example herein, particularly any one of examples 115 - 1 16, wherein the measuring displacement comprises measuring distances relative to one or more axes of the sequential images.

[0470] Example 121. The system of any example herein, particularly any one of examples 115- 120, wherein the plurality of steps further comprises: for each of the sequential images, determining which portion of the frame has the greatest displacement; and for each portion of the frame, counting the number of images where the respective portion had the greatest displacement, and wherein the classification is based at least in part on the counted number of images.

[0471] Example 122. The system of any example herein, particularly any one of examples 115- 120, wherein the plurality of steps further comprises determining an average of the measured displacements for each of the plurality of points, and wherein the classification is based at least in part on the determined averages.

[0472] Example 123. The system of any example herein, particularly any one of examples 115- 122, wherein the sequential images are received from an imager, and wherein the imager is shifted by a predetermined distance between sequential images.

[0473] Example 124. A system for identification of medical device specifications prior to diameter measurement, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving an image showing the medical device; identifying within the image identification features associated with the medical device; comparing the identification features to stored data of valve types in the memory; and based at least in part on an outcome of the comparison, determining a diameter of the medical device.

[0474] Example 125. The system of any example herein, particularly example 124, wherein identifying identification features comprises detecting radiopaque markers and structural elements visible under fluoroscopy.Attorney Docket No: TH VVA- 13387 WO01

[0475] Example 126. The system of any example herein, particularly example 124. wherein identifying identification features comprises detecting markers positioned on a delivery apparatus carrying the medical device.

[0476] Example 127. The system of any example herein, particularly example 126, wherein the markers are positioned on at least one of a balloon catheter, a nosecone, central markers, and valve positioning indicators of the delivery apparatus.

[0477] Example 128. The system of any example herein, particularly example 124, wherein identifying identification features comprises detecting external identification markers placed within an imaging field.

[0478] Example 129. The system of any example herein, particularly example 124, wherein the plurality of steps further comprises: receiving part number input; processing serial number information; or accessing valve specifications through barcode scanning interfaces.

[0479] Example 130. The system of any example herein, particularly any one of examples 124- 129, wherein the plurality of steps further comprises, based at least in part on the outcome of the comparison, identifying a type of the medical device.

[0480] Example 131. The system of any example herein, particularly example 130, wherein the plurality of steps further comprises verifying that an identified medical device type is allowable.

[0481] Example 132. The system of any example herein, particularly example 131, wherein the plurality of steps further comprises preventing the diameter determination responsive to the identified medical device type not being allowable.

[0482] Example 133. The system of any example herein, particularly any one of examples 130 - 132, wherein the determination of the diameter of the medical device is based at least in part on one or more respective height-to-diameter ratio values, and wherein the plurality of steps further comprises, based at least in part on the identification of the type of the medical device, selecting the respective height-to-diameter ratio values.

[0483] Example 134. The system of any example herein, particularly any one of example 130- 133, wherein the plurality of steps further comprises, based at least in part on the identification of the type of the medical device, adjusting neural network settings for respective characteristics associated with the identified features.

[0484] Example 135. The system of any example herein, particularly any one of examples 130- 134, wherein the plurality of steps further comprises providing feedback regarding identification status of the medical device.Attorney Docket No: TH VVA- 13387 WO01

[0485] Example 136. A system for selective presentation of diameter measurements of an expandable medical device, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving a target expansion diameter for a medical device; during expansion of the medical device, determining a current diameter of the medical device; determining whether the current diameter exceeds a predetermined threshold percentage of the target expansion diameter; and outputting diameter information when the current diameter exceeds the predetermined threshold percentage of the target expansion diameter.

[0486] Example 137. The system of any example herein, particularly example 136. wherein the predetermined threshold percentage is selected from a group including 80%, 85%, 90%, and 95% of the target expansion diameter.

[0487] Example 138. The system of any example herein, particularly example 136, wherein the plurality of steps further comprises receiving a medical device size selection for the medical device, and wherein receiving the target expansion diameter comprises presenting a plurality target diameter options associated with the selected medical device size.

[0488] Example 139. The system of any example herein, particularly example 138, wherein the medical device size selection comprises selecting from predetermined medical device working ranges.

[0489] Example 140. The system of any example herein, particularly any one of examples 136- 139, wherein the outputting diameter information comprises displaying the diameter information on a visual display.

[0490] Example 141. The system of any example herein, particularly any one of examples 136 - 139, wherein the target expansion diameter accounts for expected recoil of the medical device using predetermined recoil values.

[0491] Example 142. The system of any example herein, particularly any one of examples 136 - 139, wherein the outputting diameter information comprises providing an audio alert or haptic feedback when the predetermined threshold is reached.

[0492] Example 143. The system of any example herein, particularly example 142, wherein the outputting diameter information comprises displaying a horizontal target bar representing the target expansion diameter including expected recoil compensation.

[0493] Example 144. The system of any example herein, particularly any one of examples 136- 143, wherein the outputting diameter information comprises displaying numerical diameter values that are updated during the expansion of the medical device.Attorney Docket No: TH VVA- 13387 WO01

[0494] Example 145. The system of any example herein, particularly any one of examples 136- 144, wherein the plurality of steps further comprises implementing progressive visual enhancements as the current diameter approaches the target expansion diameter, including at least one of modifying color coding, adjusting numerical formatting, or increasing update frequency of diameter readings.

[0495] Example 146. The system of any example herein, particularly any one of examples 136 - 145, wherein the plurality of steps further comprises controlling expansion of the medical device based on the current diameter reaching the target expansion diameter.

[0496] Example 147. The system of any example herein, particularly example 146, wherein the controlling expansion comprises controlling a pump to cease pumping inflation fluid into a balloon expanding the medical device.

[0497] Example 148. A system for determining diameter measurements of an expandable medical device having a frame configured to maintain a constant height throughout expansion, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving one or more images showing the medical device during expansion thereof; measuring the height of the frame at multiple locations within the one or more images, the multiple locations comprising front and rear portions of the frame; calculating an average of the measured heights from the multiple locations; establishing a pixel-to-millimeter conversion factor by comparing the measured heights to a known physical height of the frame; and determining a diameter of the medical device using the established pixel-to-millimeter conversion factor.

[0498] Example 149. The system of any example herein, particularly example 148, wherein the measuring the height at multiple locations comprises measuring height at four locations comprising front, rear, left, and right portions of the frame.

[0499] Example 150. The system of any example herein, particularly example 148, wherein the plurality of steps further comprises determining a tilt angle of the medical device, and wherein the determination of the diameter is based at least in part on the determined tilt angle.

[0500] Example 151. The system of any example herein, particularly any one of examples 148- 150, wherein the determining the tilt angle comprises analyzing elliptical distortion of the frame in the one or more images.Attorney Docket No: TH VVA- 13387 WO01

[0501] Example 152. The system of any example herein, particularly example 151. wherein the plurality of steps further comprises analyzing an elliptical distortion of the medical device by calculating a ratio between minor and major ellipse diameters at an end of the frame.

[0502] Example 153. The system of any example herein, particularly any one of examples 148 - 152, wherein the plurality of steps further comprises detecting that the frame is configured to maintain a constant height throughout expansion by monitoring height stability over multiple images during expansion.

[0503] Example 154. The system of any example herein, particularly any one of examples 148 - 153, wherein the plurality of steps further comprises identifying ellipses at inflow and outflow ends of the frame using contour detection algorithms that detect outer boundaries of the frame.

[0504] Example 155. The system of any example herein, particularly example 154, wherein the contour detection algorithms apply ellipse-fitting algorithms to detected contours to establish elliptical references for diameter measurement.

[0505] Example 156. The system of any example herein, particularly any one of examples 154 - 155, wherein the pixel-to-millimeter conversion factor is applied to diameter measurements obtained through height-to-diameter ratio analysis.

[0506] Example 157. The system of any example herein, particularly any one of examples 148 - 156, wherein the plurality of steps further comprises maintaining compatibility with existing diameter measurement frameworks for expandable medical devices having a frame that does not maintain a constant height throughout expansion.

[0507] Example 158. A system for determining dimensions of a medical device within an image, wherein the medical device has a plurality of markers disposed thereon defining at least one ellipse, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving one or more images showing the medical device; determining a tilt angle of the medical device based on a ratio between minor and major ellipse diameters of the at least one ellipse; measuring one or more dimensions of the medical device; and correcting the measured one or more dimensions based at least in part on the determined tilt angle.

[0508] Example 159. The system of any example herein, particularly example 158, wherein the markers comprise radiopaque marker sets positioned at axially spaced locations along the medical device.Attorney Docket No: TH VVA- 13387 WO01

[0509] Example 160. The system of any example herein, particularly example 159. wherein the plurality of markers comprises a plurality of sets of markers, each set defining a respective ellipse around a circumference of the medical device.

[0510] Example 161. The system of any example herein, particularly example 160, wherein each marker set comprises at least four markers.

[0511] Example 162. The system of any example herein, particularly any one of examples 159- 161, wherein the marker sets are spaced 1 - 3 millimeters apart from each other.

[0512] Example 163. The system of any example herein, particularly any one of examples 158- 162, wherein the determining the tilt angle comprises determining a trigonometric relation between the minor and major ellipse diameters.

[0513] Example 164. The system of any example herein, particularly any one of examples 158- 163, wherein the correcting comprises dividing a length of the medical device by a cosine of the determined tilt angle.

[0514] Example 165. The system of any example herein, particularly any one of examples 158 - 164, wherein the plurality of steps further comprises providing real-time diameter assessment feedback for medical device repositioning or reorientation during delivery.

[0515] Example 166. A method for identifying spatial orientation of a medical device frame in fluoroscopic images, the method comprising: receiving a plurality of sequential images showing a medical device frame; identifying a plurality of points on the medical device frame in each of the plurality of sequential images: measuring displacement of the plurality of points between the sequential images; and classifying portions of the medical device frame as front or rear based at least in part on the measured displacements.

[0516] Example 167. The method of any example herein, particularly example 166, wherein classifying portions comprises determining that portions with larger displacements are closer to an imaging source.

[0517] Example 168. The method of any example herein, particularly any one of examples 166- 167, wherein identifying specific points comprises identifying elliptical contours at inflow and outflow ends of the medical device frame.

[0518] Example 169. The method of any example herein, particularly example 168, wherein the plurality of points comprises points where a diameter of the respective elliptical contours intersects a perimeter of the respective ellipse.

[0519] Example 170. The method of any example herein, particularly example 169, wherein the measuring displacement comprises measuring distances relative to one or more axes of an elliptical contour of the medical device frame.Attorney Docket No: TH VVA- 13387 WO01

[0520] Example 171. The method of any example herein, particularly any one of examples 166- 167, wherein the measuring displacement comprises measuring distances relative to one or more axes of the sequential images.

[0521] Example 172. The method of any example herein, particularly any one of examples 166- 171, further comprising: for each of the sequential images, determining which portion of the frame has the greatest displacement; and for each portion of the frame, counting the number of images where the respective portion had the greatest displacement, and wherein the classification is based at least in part on the counted number of images.

[0522] Example 173. The method of any example herein, particularly any one of examples 166- 171, further comprising determining an average of the measured displacements for each of the plurality of points, wherein the classification is based at least in part on the determined averages.

[0523] Example 174. The method of any example herein, particularly any one of examples 166- 173, wherein the sequential images are received from an imager, and wherein the method further comprises shifting the imager by a predetermined distance between sequential images.

[0524] Example 175. A method for identification of medical device specifications prior to diameter measurement, wherein the method comprises: receiving an image showing the medical device; identifying within the image identification features associated with the medical device; comparing the identification features to stored data of valve types; and based at least in part on an outcome of the comparison, determining a diameter of the medical device.

[0525] Example 176. The method of any example herein, particularly example 175, wherein identifying identification features comprises detecting radiopaque markers and structural elements visible under fluoroscopy.

[0526] Example 177. The method of any example herein, particularly example 175, wherein identifying identification features comprises detecting markers positioned on a delivery apparatus carrying the medical device.

[0527] Example 178. The method of any example herein, particularly example 177, wherein the markers are positioned on at least one of a balloon catheter, a nosecone, central markers, and valve positioning indicators of the delivery apparatus.

[0528] Example 179. The method of any example herein, particularly example 175, wherein identifying identification features comprises detecting external identification markers placed within an imaging field.Attorney Docket No: TH VVA- 13387 WO01

[0529] Example 180. The method of any example herein, particularly example 175, further comprising: receiving a part number input; processing serial number information; or accessing valve specifications through barcode scanning interfaces.

[0530] Example 181 . The method of any example herein, particularly any one of examples 175- 180, further comprising, based at least in part on the outcome of the comparison, identifying a type of the medical device.

[0531] Example 182. The method of any example herein, particularly example 181, further comprising verifying that an identified medical device type is allowable.

[0532] Example 183. The method of any example herein, particularly example 182, further comprising preventing the diameter determination responsive to the identified medical device type not being allowable.

[0533] Example 184. The method of any example herein, particularly any one of examples 181 - 183, wherein the determination of the diameter of the medical device is based at least in part on one or more respective height-to-diameter ratio values, and wherein the method further comprises, based at least in part on the identification of the type of the medical device, selecting the respective height-to-diameter ratio values.

[0534] Example 185. The method of any example herein, particularly any one of example 181- 184, further comprising, based at least in part on the identification of the type of the medical device, adjusting neural network settings for respective characteristics associated with the identified features.

[0535] Example 186. The method of any example herein, particularly any one of examples 181- 185, further comprising providing feedback regarding identification status of the medical device.

[0536] Example 187. A method for selective presentation of diameter measurements of an expandable medical device, wherein the method comprises: receiving a target expansion diameter for a medical device; during expansion of the medical device, determining a current diameter of the medical device; determining whether the current diameter exceeds a predetermined threshold percentage of the target expansion diameter; and outputting diameter information when the current diameter exceeds the predetermined threshold percentage of the target expansion diameter.

[0537] Example 188. The method of any example herein, particularly example 187, wherein the predetermined threshold percentage is selected from a group including 80%, 85%, 90%,Attorney Docket No: TH VVA- 13387 WO01

[0538] Example 189. The method of any example herein, particularly example 187, further comprising receiving a medical device size selection for the medical device, and wherein receiving the target expansion diameter comprises presenting a plurality of target diameter options associated with the selected medical device size.

[0539] Example 190. The method of any example herein, particularly example 189, wherein the medical device size selection comprises selecting from predetermined medical device working ranges.

[0540] Example 191. The method of any example herein, particularly any one of examples 187 - 190, wherein outputting diameter information comprises displaying the diameter information on a visual display.

[0541] Example 192. The method of any example herein, particularly any one of examples 187 - 190, wherein the target expansion diameter accounts for expected recoil of the medical device using predetermined recoil values.

[0542] Example 193. The method of any example herein, particularly any one of examples 187 - 190, wherein the outputting diameter information comprises providing an audio alert or haptic feedback when the predetermined threshold is reached.

[0543] Example 194. The method of any example herein, particularly example 193, wherein the outputting diameter information comprises displaying a horizontal target bar representing the target expansion diameter including expected recoil compensation.

[0544] Example 195. The method of any example herein, particularly any one of examples 187- 190, wherein the outputting diameter information comprises displaying numerical diameter values that are updated during the expansion of the medical device.

[0545] Example 196. The method of any example herein, particularly any one of examples 187- 195, further comprising implementing progressive visual enhancements as the cunent diameter approaches the target expansion diameter, including at least one of modifying color coding, adjusting numerical formatting, or increasing update frequency of diameter readings.

[0546] Example 197. The method of any example herein, particularly any one of examples 187- 196, further comprising controlling expansion of the medical device based on the current diameter reaching the target expansion diameter.

[0547] Example 198. The method of any example herein, particularly example 197, wherein the controlling expansion comprises controlling a pump to cease pumping inflation fluid into a balloon expanding the medical device.

[0548] Example 199. A method for determining diameter measurements of an expandable medical device having a frame configured to maintain a constant height throughout expansion,Attorney Docket No: TH VVA- 13387 WO01 wherein the method comprises: receiving one or more images showing the medical device during expansion thereof; measuring the height of the frame at multiple locations within the one or more images, the multiple locations comprising front and rear portions of the frame; calculating an average of the measured heights from the multiple locations; establishing a pixel-to-millimeter conversion factor by comparing the measured heights to a known physical height of the frame; and determining a diameter of the medical device using the established pixel-to-millimeter conversion factor.

[0549] Example 200. The method of any example herein, particularly example 199, wherein the measuring the height at multiple locations comprises measuring height at four locations comprising front, rear, left, and right portions of the frame.

[0550] Example 201. The method of any example herein, particularly example 200, further comprising determining a tilt angle of the medical device, and wherein the determining the diameter is based at least in part on the determined tilt angle.

[0551] Example 202. The method of any example herein, particularly any one of examples 199 - 201, wherein the determining the tilt angle comprises analyzing elliptical distortion of the frame in the one or more images.

[0552] Example 203. The method of any example herein, particularly example 202, further comprising analyzing an elliptical distortion of the medical device by calculating a ratio between minor and major ellipse diameters at an end of the frame.

[0553] Example 204. The method of any example herein, particularly any one of examples 199- 203, further comprising detecting that the frame is configured to maintain a constant height throughout expansion by monitoring height stability over multiple images during expansion.

[0554] Example 205. The method of any example herein, particularly any one of examples 199- 204, further comprising identifying ellipses at inflow and outflow ends of the frame using contour detection algorithms that detect outer boundaries of the frame.

[0555] Example 206. The method of any example herein, particularly example 205, wherein the contour detection algorithms apply ellipse-fitting algorithms to detected contours to establish elliptical references for diameter measurement.

[0556] Example 207. The method of any example herein, particularly any one of examples 205- 206, wherein the pixel-to-millimeter conversion factor is applied to diameter measurements obtained through height-to-diameter ratio analysis.

[0557] Example 208. The method of any example herein, particularly any one of examples 199- 207, further comprising maintaining compatibility with existing diameter measurementAttorney Docket No: TH VVA- 13387 WO01 frameworks for expandable medical devices having a frame that does not maintain a constant height throughout expansion.

[0558] Example 209. A method for determining dimensions of a medical device within an image, wherein the medical device has a plurality of markers disposed thereon defining at least one ellipse, wherein the method comprises: receiving one or more images showing the medical device; determining a tilt angle of the medical device based on a ratio between minor and major ellipse diameters of the at least one ellipse; measuring one or more dimensions of the medical device; and correcting the measured one or more dimensions based at least in part on the determined tilt angle.

[0559] Example 210. The method of any example herein, particularly example 209, wherein the markers comprise radiopaque marker sets positioned at axially spaced locations along the medical device.

[0560] Example 211. The method of any example herein, particularly example 210, wherein the plurality of markers comprises a plurality of sets of markers, each set defining a respective ellipse around a circumference of the medical device.

[0561] Example 212. The method of any example herein, particularly example 211, wherein each marker set comprises at least four markers.

[0562] Example 213. The method of any example herein, particularly any one of examples 210 - 212, wherein the marker sets are spaced 1 - 3 millimeters apart from each other.

[0563] Example 214. The method of any example herein, particularly any one of examples 209- 213, wherein the determining the tilt angle comprises determining a trigonometric relation between the minor and major ellipse diameters.

[0564] Example 215. The method of any example herein, particularly any one of examples 209 - 214, wherein the correcting comprises dividing a length of the medical device by a cosine of the determined tilt angle.

[0565] Example 216. The method of any example herein, particularly any one of examples 209- 215, further comprising providing real-time diameter assessment feedback for medical device repositioning or reorientation during delivery.

[0566] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the contextAttorney Docket No: TH VVA- 13387 WOOl of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0567] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope.

Claims

Attorney Docket No: TH VYA- 13387 WOOlCLAIMS1. A system for determining an expected expansion diameter of an expandable medical device, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving one or more images showing the medical device being expanded; for each of the received one or more images, identifying one or more features of the medical device; for each of the received one or more images, based at least in part on the identified one or more features, determining an image diameter of the medical device, the image diameter being the diameter of the medical device at an imaging time when the respective image was taken; based at least in part on the determined image diameter of the medical device and one or more recoil values, determining the expected expansion diameter of the medical device, the expected expansion diameter reflecting the expected diameter of the medical device if the medical device would recoil at the imaging time; and for at least one of the one or more images, outputting information regarding the determined expected expansion diameter of the medical device.

2. The system of claim 1, wherein the received one or more images comprises a series of fluoroscopic images.

3. The system of claim 2, wherein the information regarding the determined expected expansion diameter of the medical device is output for each of the series of fluoroscopic images.

4. The system of any one of claims 1 - 3, wherein the plurality of steps further comprises: receiving a respective user input indicating a target expansion diameter for the medical device; for each of the one or more images, comparing the determined expected expansion diameter of the medical device to the target expansion diameter; andAttorney Docket No: TH VVA- 13387 WOOl for each of the one or more images, outputting an indication of an outcome of the comparison.

5. The system of any one of claims 1 - 4, further comprising receiving a respective user input indicating a type of the medical device, wherein the one or more recoil values are based at least in part on the type of the medical device.

6. The system of any one of claims 1 - 5, wherein the plurality of steps further comprises: comparing the determined expected expansion diameter to a respective threshold; and based at least in part on an outcome of the comparison to the respective threshold, ceasing the expansion of the medical device, wherein the medical device is a balloon expandable medical device, and wherein the ceasing of the expansion of the medical device comprising controlling a pump to stop pumping inflation fluid into a balloon that is expanding the medical device.

7. A system of determining a diameter of an expandable medical device during expansion thereof, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising; receiving an image showing the medical device being expanded, utilizing a parameter identification neural network (NN) to identify within the received image a first plurality of parameters defining a respective ellipse at a first portion of the medical device, based at least in part on the identified first plurality of parameters, determining a diameter of the medical device, and outputting information regarding the determined diameter.

8. The system of claim 7, wherein the plurality of steps further comprises utilizing the parameter identification NN to identify within the received image a second plurality of parameters defining a respective ellipse at a second portion of the medical device,Attorney Docket No: TH VVA- 13387 WOOl wherein the determination of the diameter of the medical device is based at least in part on the identified second plurality of parameters.

9. The system of claim 7 or 8, wherein the first plurality of parameters comprises a first plurality of points.

10. The system of any one of claims 7 - 9, wherein the plurality of steps further comprises determining a height of the medical device within the received image, wherein the determination of the diameter of the medical device is based at least in part on the detemrined height.

11. The system of claim 10, wherein the plurality of steps further comprises utilizing the parameter identification NN to identify within the received image a third set of points, the height determined based at least in part on the third set of points.

12. The system of claim 11, wherein the third plurality of points are located between an inflow end and an outflow end of the medical device.

13. The system of any one of claims 11 or 12, wherein a first and second of the third plurality of points are on opposing sides of the medical device.

14. The system of any one of claims 7 to 13, wherein the parameter identification NN outputs a plurality of heatmaps, and wherein the plurality of steps further comprises identifying the first plurality of parameters and second plurality of parameters within the output heatmaps.

15. The system of any one of claims 7 - 14, wherein the plurality of steps further comprises utilizing a region of interest (ROI) neural network (NN) to define within the received image a region of interest comprising the medical device, wherein the identification of the first and second plurality of parameters is performed within the defined region of interest.

16. The system of claim 15, wherein the ROI NN determines an orientation of the medical device within the image, andAttorney Docket No: TH VVA- 13387 WOOl wherein the determination of the orientation of the medical device is based at least in part on a classification based technique defining a plurality of classes, each of the plurality of classes representing a respective angle.

17. A system for identification of medical device specifications prior to diameter measurement, wherein the system comprises: a memory; and one or more processors, the memory having stored therein a plurality of instructions that when read by the one or more processors cause the one or more processors to perform a plurality of steps, the plurality of steps comprising: receiving an image showing the medical device; identifying within the image identification features associated with the medical device; comparing the identification features to stored data of valve types in the memory; and based at least in part on an outcome of the comparison, determining a diameter of the medical device.

18. The system of claim 17, wherein the plurality of steps further comprises, based at least in part on the outcome of the comparison, identifying a type of the medical device.

19. The system of claim 18, wherein the plurality of steps further comprises verifying that an identified medical device type is allowable.

20. The system of claim 19, wherein the plurality of steps further comprises preventing the diameter determination responsive to the identified medical device type not being allowable.

21. The system of any one of claims 17 - 20, wherein the determination of the diameter of the medical device is performed during expansion of the medical device, and wherein the plurality of steps further comprises: receiving a target expansion diameter for the medical device; determining whether the determined diameter exceeds a predetermined threshold percentage of the target expansion diameter; and outputting diameter information when the determined diameter exceeds the predetermined threshold percentage of the target expansion diameter.Attorney Docket No: TH VVA- 13387 WOOl22. The system of claim 21 , wherein the plurality of steps further comprises receiving a medical device size selection for the medical device, and wherein receiving the target expansion diameter comprises presenting a plurality of target diameter options associated with the selected medical device size.

23. The system of claim 22, wherein the medical device size selection comprises selecting from predetermined medical device working ranges.

24. The system of any one of claims 21 - 23, wherein the outputting diameter information comprises displaying the diameter information on a visual display.

25. The system of any one of claims 21 - 24, wherein the outputting diameter information comprises providing feedback when the predetermined threshold is reached, wherein the feedback is selected from the group consisting of audio, visual and haptic feedback.

26. The system of any one of claims 21 - 25, wherein the outputting diameter information comprises displaying a horizontal bar representing the determined diameter in relation to the target expansion diameter.

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