Systems and methods of fluid passageway cross-sectional area determination in anatomy

Abstract

To provide systems and methods of fluid passageway cross-sectional area determination in an anatomy.SOLUTION: The systems and methods include steps of: obtaining one or more images of the passageway; placing at least a portion of a representation of a prosthetic device in the one or more images of the passageway at a position; determining a starting plane that intersects at least one point of a surface of the representation of the prosthetic device at the position, at least one point in a volume defined by the passageway, and at least one point on a boundary of the passageway in the one or more images of the passageway; creating a plurality of section planes based on rotating the starting plane one or more times about one or more axes; calculating a difference between a first cross-sectional area, which is an intersection of the at least the portion of the representation of the prosthetic device at the position and the corresponding section plane, and a second cross-sectional area, which is an intersection of the volume and the corresponding section plane; and calculating a surface area of the resulting corresponding cross section as the corresponding cross-sectional area.SELECTED DRAWING: Figure 5D

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 841,651, filed May 1, 2019, the contents of each of which are incorporated herein by reference in their entirety.

[0002] This application relates to determining cross-sectional areas in patient anatomical structures. In some aspects, this application specifically relates to determining cross-sectional areas (e.g., minimum, maximum, average, etc.) in volumes corresponding to flow paths of anatomical structures such as valves, arteries, veins, ducts, airways, etc. [Background technology]

[0003] The human heart is a complex organ with many working parts that are important for the proper functioning of the heart to circulate blood throughout the body. The human heart is generally composed of four hollow chambers: the right atrium, the right ventricle, the left atrium, and the left ventricle. One of the keys to a properly functioning heart is the regulation of blood flow through these chambers. The regulation of blood flow through and between these chambers is achieved by valves. For example, there is an atrioventricular opening between the right atrium and the right ventricle.

[0004] The tricuspid valve is located at the atrioventricular opening and allows blood to move from the right atrium to the right ventricle. When the pressure in the atrium is greater than the pressure in the ventricle, the tricuspid valve opens. When the tricuspid valve opens, blood is allowed to flow from the right atrium to the right ventricle. When the pressure in the right ventricle increases, the tricuspid valve closes. When the tricuspid valve closes, blood cannot flow back in the other direction.

[0005] In a healthy heart, blood flow is also regulated between the left atrium and the left ventricle. Now, when the left atrium fills with blood and the blood pressure in the left atrium increases to a level above that of the left ventricle, the mitral valve allows blood to flow from the left atrium to the left ventricle. When the mitral valve opens, blood flows downward from the left atrium to the left ventricle, where it is pumped to the rest of the body as part of the larger circulatory process. When a healthy mitral valve closes, blood stops flowing between the two chambers, and this blockage prevents blood from flowing backwards.

[0006] Unfortunately, the mitral valve does not always function properly. When the mitral valve functions abnormally, severe health problems can occur. One abnormality associated with the mitral valve is mitral regurgitation ("MR"). Mitral regurgitation is a condition in which the mitral valve does not close properly when the left ventricle contracts. This causes blood that has entered the left ventricle from the left atrium to flow backward into the left atrium.

[0007] Mitral regurgitation may be treated with surgery. One surgical option involves mitral valve replacement, where the mitral valve is replaced with a prosthetic mitral valve, such as a bioprosthetic or artificial replacement. Another surgical option is mitral valve repair. Mitral valve repair is generally considered preferable to mitral valve replacement because it is a less invasive procedure, but both options require an open-heart procedure. Since many candidates for mitral valve replacement and repair are not good candidates to withstand the stresses of an open-heart procedure, research is ongoing in the field of transcatheter mitral valve replacement (TMVR). With TMVR, a prosthetic mitral valve can be introduced using a catheter-based system. The catheter-based system eliminates the need for open-heart surgery.

[0008] For example, a prosthetic mitral valve may be placed inside a beating heart via a catheter into the base of the heart through a tube inserted into a small incision in the patient's chest. The physician uses the tube to place the prosthetic mitral valve and positions it so that it rests on the existing mitral valve in the heart. Using catheter-based injection techniques, the physical trauma associated with open-heart surgery is minimized, and more patients may be effectively treated for mitral regurgitation disease.

[0009] Mitral valve prostheses for TMVR have been developed in different shapes and sizes. Therefore, traditionally, before surgery, the clinician needs to determine which model and size of the prosthetic mitral valve is most suitable for the patient and how the prosthetic mitral valve should be positioned in the patient's heart.

[0010] One possible complication is that the prosthetic mitral valve may partially block the left ventricular outflow tract (LVOT), making it difficult for blood to leave the heart toward the aorta. However, because the heart has a complex three-dimensional shape, determining the LVOT and the degree of possible blockage of the LVOT is not a simple task. Summary of the Invention

[0011] Certain embodiments provide a method for determining information regarding multiple cross-sectional areas of a passageway of an anatomical structure for fluid flow. The method includes obtaining a three-dimensional ("3-D") model of the passageway; placing at least a portion of a representation of a prosthesis on the 3-D model of the passageway; determining a starting plane that intersects at least one point on a surface of the representation of the prosthesis, at least one point within a volume defined by the passageway, and at least one point on the surface of the passageway; generating a plurality of cutting planes based on rotating the starting plane one or more times about one or more axes; calculating a plurality of cross-sectional areas corresponding to the plurality of cutting planes, each cross-sectional area being calculated as a difference between a first cross-sectional area that is an intersection of the volume with a corresponding cutting plane and a second cross-sectional area that is an intersection of the at least a portion of the representation of the prosthesis with the corresponding cutting plane; determining one of a maximum or minimum cross-sectional area of ​​the plurality of cross-sectional areas; comparing one of the maximum or minimum cross-sectional area to a threshold value; and selectively modifying the prosthesis corresponding to the representation of the prosthesis based on the comparison.

[0012] Certain embodiments provide a non-transitory computer-readable medium having computer-executable instructions stored thereon that, when executed by a processor of a computing device, cause the computing device to perform the methods described above.

[0013] Certain embodiments provide a computing device comprising a memory and a processor configured to perform the above-described methods. [Brief description of the drawings]

[0014] [Figure 1] The left side of a digital 2-D or 3-D model of the heart is shown. [Diagram 2] FIG. 1 is a functional block diagram of an example computing environment suitable for implementing various embodiments disclosed herein. [Diagram 3]FIG. 1 is a high-level system diagram of a computer system that can be used in accordance with one or more embodiments. [Figure 4] 1 shows a flowchart illustrating a procedure for determining a minimum cross-sectional area of ​​a volume, according to certain embodiments. [Figure 4A] 1 shows a flowchart illustrating a procedure for determining a minimum cross-sectional area of ​​a volume, according to certain embodiments. [Figure 5A] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5B] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5C] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5D] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5E] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5F] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5G] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 5H] 1 shows a diagram of an example 3-D model of a heart along with a depiction of a prosthetic mitral valve included in the 3-D model. [Figure 6] 1 is a flowchart illustrating a procedure for generating multiple cutting planes in accordance with certain embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] As mentioned above, the prosthetic mitral valve may cause occlusion of the LVOT, thereby reducing blood flow exiting the heart towards the aorta. For example, the introduction of a prosthetic mitral valve, such as using TMVR, may change the size and shape of the original LVOT into a modified LVOT called a neo-LVOT. The neo-LVOT may have a reduced volume compared to the original LVOT due to the prosthetic mitral valve protrusion into the LVOT. Furthermore, the cross-sectional area of ​​the neo-LVOT may be reduced compared to the cross-sectional area of ​​the LVOT. The area of ​​the neo-LVOT as used herein may be referred to as the cross-sectional area of ​​the neo-LVOT.

[0016] The amount of blood flow through a volume (e.g., valve, vein, artery, LVOT, neo-LVOT, etc.) may be directly related to the smallest cross-sectional area through which blood flows within the volume, since the smallest cross-sectional area acts as a bottleneck for blood flow through the volume. Thus, blood flow through the neo-LVOT may be directly related to the smallest neo-LVOT area of ​​the LVOT.

[0017] Adequate blood flow through the neo-LVOT is crucial to ensure patient viability after the insertion of a prosthetic mitral valve. Without adequate blood flow, patients may experience complications or even die. Therefore, a sound calculation of the simulated neo-LVOT area helps to reduce the chance of complications in mitral valve replacement by facilitating the demonstration of blood flow through the neo-LVOT prior to mitral valve replacement.

[0018] In certain embodiments herein, a human, such as a clinician, technician, or specialist, may use a computer device, or the computer device itself may automatically (e.g., iteratively) position one or more different 3-D digital models of a prosthetic mitral valve in one or more different positions within a 3-D digital model of a patient's anatomy. Alternatively, a human, such as a clinician, technician, or specialist, may load one or more treatment plans, each of which includes a 3-D digital model of a prosthetic mitral valve in a specific position of the 3-D digital model of the patient's anatomy. According to embodiments described herein, the computer device may determine a minimum area of ​​the neo-LVOT at each position of each prosthetic mitral valve. The human or computer device may then automatically select a suitable prosthetic mitral valve design and / or position that provides sufficient blood flow through the neo-LVOT (e.g., maximum blood flow, minimum percentage of blood flow compared to the original LVOT, etc.) based on the minimum area of ​​the neo-LVOT determined at each position of each prosthetic mitral valve.

[0019] Accordingly, certain embodiments herein provide systems and methods for determining the minimum neo-LVOT area. Additionally, certain embodiments herein provide systems and methods for selecting an appropriate mitral valve prosthesis design and / or location based on the determined minimum neo-LVOT area. Certain embodiments provide for automatically generating a custom mitral valve prosthesis design based on an analysis of the neo-LVOT area. Certain implementations provide for automatically adapting the mitral valve prosthesis design (e.g., adjusting the shape, fixation system, location, organ coverage, etc.) based on an analysis of the neo-LVOT area (e.g., starting with a standard design and iteratively modifying the design according to certain constraints).

[0020] It should be noted that although certain embodiments are described herein with respect to determining the minimum neo-LVOT area of ​​a neo-LVOT, the techniques described herein may be used to determine information regarding the cross-sectional area of ​​any suitable volume, particularly information regarding the passageways of an anatomical structure for blood flow, air circulation, etc. As an example, the techniques described herein may be used to determine the minimum cross-sectional area of ​​a volume, the maximum cross-sectional area of ​​a volume, the average cross-sectional area of ​​a volume, etc.

[0021] Such techniques may further be used to check for occlusion of other passageways after placement of other prostheses, and to look for leaks next to organs (e.g., valves, left atrial appendage (LAA) occlusion, stent grafts for aortic aneurysms, cerebral aneurysm organs, etc.). Such techniques may also be used for applications other than blood flow, such as considering airflow when planning pulmonary interventions. For example, the techniques may be used for airways, treatment of airway diseases, and replacement of prostheses (e.g., stents, grafts, valves, drug delivery systems) within the airways, etc. Such techniques may also be used to find the A2 minimum distance of the neo-LVOT (e.g., the distance between the A2 portion of the anterior leaflet of the mitral valve and the septal wall).

[0022] FIG. 1 shows the left side of a digital 2-D or 3-D model of a heart 100. In particular, the aorta 105, left ventricle 107, and left atrium 109 of the heart 100 are shown. Also shown is the placement of a prosthetic mitral valve 111 in the location of the actual mitral valve of the heart 100 between the left atrium 109 and the left ventricle 107. Note that in certain embodiments, the prosthetic mitral valve 111 is a representation of the prosthetic mitral valve 111, such as a shape (e.g., cylindrical) that corresponds to the approximate dimensions of the prosthetic mitral valve 111 or a shape that is the same as the prosthetic mitral valve 111. The placement of the mitral valve 111 within the heart 100 along the anatomy of the aorta 105 and left ventricle 107 clearly shows the contours of the neo-LVOT. Conventionally, the minimum area of ​​the neo-LVOT is roughly estimated visually using a 2D centerline method that begins by drawing a spline 113 (e.g., a 2D spline) along an estimate of the centerline of the original LVOT volume on one or more 2D images. Drawing the spline 113 is done manually by a human and is prone to errors due to inaccurate estimation of the centerline. The human may then select and draw a plane 115 that intersects the bottom of the mitral valve 111 and is perpendicular to the spline 113. The human may manually select the location of the plane 115 at a location that visually appears to be a small cross-section. The distance from the mitral valve 111 along the plane 115 to the inner wall of the left ventricle 107 and / or aorta 105 is then calculated and used as an estimate of the minimum area of ​​the neo-LVOT.

[0023] Such estimates of the minimum neo-LVOT area are rough and estimates for the same heart 100 with the same mitral valve prosthesis 111 placed in the same location will vary greatly depending on the person making the estimate. In particular, estimates of the minimum neo-LVOT area may be inaccurate, which may lead to improper selection and placement of the mitral valve prosthesis 111 in the patient's heart, resulting in complications or even death.

[0024] Unlike conventional methods, the systems and methods described herein provide a robust and accurate determination of the minimum neo-LVOT area. Such systems and methods advance the art of medicine and medical technology by efficiently and accurately calculating the minimum neo-LVOT area so that an appropriate prosthetic mitral valve may be selected and placed within a patient's anatomy while maintaining adequate blood flow through the neo-LVOT. Such techniques advance the art of medicine and medical technology by reducing the chance of patient complications due to improper neo-LVOT calculations and prosthetic mitral valve placement and design. Such techniques further advance the capabilities of the computing device itself used to calculate the minimum neo-LVOT area by providing an efficient, defined computer system that efficiently finds the minimum cross-sectional area within a volume using reduced computing cycles compared to other, more complex techniques.

[0025] The systems and methods described herein may be implemented in a computing environment that includes one or more computing devices configured to provide various functions. FIG. 2 is an example of a computing environment 200 suitable for implementing certain embodiments described herein. The computing environment 200 may include a network 202. The network 202 may take various forms. For example, the network 202 may be a local area network located in an operating room. In some embodiments, the network 202 may be a wide area network such as the Internet. In other embodiments, the network 202 may be a combination of a local area network and a wide area network. Typically, a network allows secure communication and data shared between various computing devices. Among these computing devices are client devices 204. The client devices 204 may be typical personal computing devices running off-the-shelf operating systems such as Windows, Mac OS, Linux, Chrome OS, or any other operating system. The client devices 204 may have application software installed to enable them to interact with various other modules and other software stored on the devices in the computing environment 200 via the network 202. This application software may take the form of a web browser that can access a remote application service, or the application software may be a client application installed on the operating system of the client device 204. The client device 204 may also take the form of a special purpose computer, particularly a computer designed for medical imaging work, or more specifically for determining the area of ​​the neo-LVOT.The client device 204 may further take the form of a mobile device or tablet computer configured to communicate over the network 202 and further configured to execute one or more software modules to enable a user to perform the various methods described herein.

[0026] The computing environment 200 may further include an image data storage 206. Typically, the image data storage 206 takes the form of a large database designed to store image files taken by the scanning device 222. These images may be DICOM images, or other types of images. The image data storage 206 may be part of the scanning device 222 or may be part of the client computing device 204. The image data storage 206 may also be in a stand-alone database, for example, a server-based system such as a PACS system, with dedicated storage optimized for medical image data. The computing environment 200 may also include a scanning device 222. The scanning device 222 may be a medical imaging device that typically scans a patient to generate images of the patient's anatomy. In the computing environment 200 shown in FIG. 2, the scanning device 222 may be a CT scanner or an MRI device. However, one skilled in the art will appreciate that other scanning techniques may be implemented that provide imaging data that can be used to generate a three-dimensional anatomical model.

[0027] As described in more detail below, the scanning device 222 may be configured to generate cross-sectional images of the patient's heart. These images may be stored in the image data storage 206 and utilized to generate a three-dimensional model of the heart. To that end, the computing environment 200 may also include an image processing module 208. The image processing module 208 may employ computer software, hardware, or a combination of both to retrieve medical image data from the image data storage 206 and generate a three-dimensional model using a stack of 2-D image data. The image processing module 208 may be a commercially available image processing software for three-dimensional design and modeling, such as Materialise NV's Mimics® application. However, other image processing software may be used. In an embodiment, the image processing module 208 may be provided via a web-based network application accessed by a computer (such as, for example, the client device 204) on the network. Alternatively, the image processing module 208 may be a software application installed directly on the client device 204 or that accesses the image data storage 206 via the network 202. In general, the image processing module 208 may be any combination of software and / or hardware disposed within the computing environment 200 that provides image processing capabilities to image data stored in the image data storage device 206 .

[0028] The computing environment may also include a three-dimensional measurement and analysis module 220 ("3-D measurement and analysis module"). The 3-D measurement and analysis module 220 may be software complementary and / or packaged with the image processing module 208. The 3-D measurement and analysis module may be an application configured to determine a minimum area of ​​the neo-LVOT. As described in more detail below, the 3-D measurement and analysis module 220 is generally used to determine accurate measurements of various aspects of the patient's anatomy and a simulated positioning of a prosthetic mitral valve to determine the minimum area of ​​the neo-LVOT. Similar to the image processing module 208, the 3-D measurement and analysis module 220 may be a network-based application accessed via a web browser by one or more client devices 204. It may also be a native application installed on the operating system of a computer, such as the client device 204. In yet other embodiments, the 3-D measurement and analysis module 220 may be a network application implemented and executed on a client / server. In certain embodiments, the 3-D measurement and analysis module 220 may operate on a three-dimensional model generated by the image processing module 208. Alternatively or additionally, the 3-D measurement and analysis module 220 may operate on image data, such as from the image data storage 206. Performing measurements on the image data may, in certain embodiments, eliminate the step of generating a three-dimensional model. However, performing measurements on the three-dimensional model may produce more accurate results, because features such as the centerline and cross-section of the lumen may be more accurately determined and the deleterious effects of noise or other artifacts in the image data may be reduced.

[0029] Various embodiments of the present invention may be implemented using general-purpose and / or special-purpose computing devices. Referring now to FIG. 3, an example of a computing device 300 suitable for implementing various embodiments is shown. The computing system 300 may generally employ some form of computing hardware configured to execute certain processes and instructions in accordance with various aspects of one or more embodiments described herein. The computing hardware may be a single computer or may be multiple computers configured to work together. The computing device 300 includes a processor 303. The processor 303 may be one or more standard personal computer processors, such as those designed and / or supplied by Intel, Advanced Micro Devices, Apple, or ARM. The processor 303 may be a more specialized processor specifically designed for image processing and / or analysis. The computing device 300 may also include a display device 304. The display device 304 may be a standard computer monitor, such as a well-known LCD monitor. The display device 304 may also employ some form of display integrated into the body of the computing device, such as included in an all-in-one computing device or tablet computer.

[0030] The computing device 300 may also include input / output devices 306. These may include standard peripherals such as a keyboard, mouse, printer, and other I / O software and hardware. The computing device 300 may also further include memory 308. The memory 308 may take a variety of forms. For example, the memory 308 may include volatile memory 310. The volatile memory 310 may be any form of random access memory and may generally be configured to load executable software modules into the memory. The software modules may then be executed by the processor 303 in a manner well known in the art. The software modules may be stored in non-volatile memory 313. The non-volatile memory 313 may take the form of a hard disk drive, flash memory, solid state hard drive, or some other form of non-volatile memory. The non-volatile memory 313 may also be used to store non-executable data, such as database files.

[0031] The computing device 300 may also include a network interface 314. The network interface may employ a network interface card and a method of communication software drivers and / or firmware configured to provide the system 300 with access to a network (such as the Internet, for example). The network interface card 314 may be configured to access a variety of different types of networks, such as those described above in connection with FIG. 2. For example, the network interface card 314 may be configured to access a private network that is not publicly accessible. The network interface card 314 may also be configured to access a wireless network using a wireless data transfer technology, such as an EVDO, WiMax, or LTE network. Although a single network interface 314 is shown in FIG. 3, there may be multiple network interface cards 314 to access different types of networks. Furthermore, a single network interface card 314 may be configured to enable access to multiple different types of networks.

[0032] 2 may generally include one, several, or many different types of computing devices 300 that cooperate to perform the various embodiments described below. For example, the image data storage 206 may be part of a server-based system, such as a PACS system, and may be accessible to the image processing module 208 and / or the 3-D measurement and analysis module 220 via a network interface 314. Those skilled in the art will readily appreciate that a variety of different types of computing devices and network configurations may be implemented to perform the inventive systems and methods disclosed herein.

[0033] 4 and 4A show a flow chart illustrating a procedure 400 for determining the minimum area of ​​the neo-LVOT, according to certain embodiments. It should be noted that in certain embodiments, procedure 400 is a computer-implemented procedure. Furthermore, certain blocks may be performed automatically by a user of a computing device, manually, or partially manually and partially automatically based on input from a user of a computing device. Furthermore, certain blocks may be optional, and some of the methods described may be performed as separate methods.

[0034] The procedure 400 begins at block 402, where one or more images of the patient's heart are acquired. The images may first be acquired using a scanning device 222, shown in FIG. 2, such as a CT scanner or an MRI device. In acquiring the images, a contrast agent may be used to improve the visibility of various internal structures of the heart. The image (or images) acquired using the scanning device 222 may be stored in the image data storage device 206 or some other computer memory accessible via the computer network 202. The image may be of all or at least a portion of the heart (e.g., at least the mitral valve and the LVOT). The images may be acquired directly from the scanning device 222, from the image data storage device 206, or from any other suitable medium, such as loading the images from a data storage device. The procedure then proceeds to block 404, where a 3-D model of the blood volume is calculated based on the acquired images. In certain embodiments, a contrast agent is used for 3-D modeling of the blood volume. The 3-D model may have been calculated using image processing module 208 or other software and / or hardware designed to generate 3-D models from CT and / or MRI image data. The 3-D model of the blood volume may be of all or at least a portion of the heart (e.g., at least the mitral valve and LVOT). In certain embodiments, block 404 is optional and subsequent blocks may instead be performed on the image. In further description of procedure 400, "3-D model" may refer to the image itself as well as a 3-D model generated from the image.

[0035] Optionally, the 3-D model of the blood volume may be used to reconstruct the cardiac anatomy in block 406 to generate a 3-D model of the heart. Alternatively, the 3-D model of the blood volume itself may be used as the 3-D model of the heart. The 3-D model of the heart may be of all or at least a portion of the heart (e.g., at least the mitral valve and the LVOT). This reconstruction may be performed using the image processing module 208.

[0036] The procedure then proceeds to step 408, where a prosthetic mitral valve design (e.g., a representation of a prosthetic mitral valve design) is selected. As discussed with respect to FIG. 1, procedure 400 may use a representation of a prosthetic mitral valve instead of an actual prosthetic mitral valve. For example, a user of a computing device, such as client device 204, may select a prosthetic mitral valve design. In one example, selecting a prosthetic mitral valve design refers to obtaining a selection of a previously generated mitral valve design (e.g., a design previously generated by a clinician). In another example, selecting a prosthetic mitral valve design refers to loading a prosthetic mitral valve design from a file, from a memory, or from a database of mitral valve designs. In another example, selecting a prosthetic mitral valve design refers to randomly (pseudo-randomly) selecting a prosthetic mitral valve design from a database of prosthetic mitral valve designs (e.g., automatically by the computing device or by a user of the computing device). In another example, selecting a prosthetic mitral valve design refers to manually or automatically selecting a prosthetic mitral valve design based on one or more measurements made on a 3-D model of the heart or blood volume, such as the diameter of a circle that best fits the mitral valve annulus, which is used to select the mitral valve design having the most matching diameter. In another example, the prosthetic mitral valve design may be selected using the techniques described in WO 2015 / 179543, which is incorporated herein by reference in its entirety.

[0037] In a following block 410, a location for implantation of the mitral valve design is obtained. For example, a user of a computing device, such as the client device 204, may select a location for the mitral valve prosthesis (e.g., randomly, visually, etc.). In another embodiment, the computing device automatically positions the mitral valve prosthesis (e.g., randomly, pseudo-randomly, based on a best fit algorithm, etc.). In another embodiment, the computing device or a user of the computing device automatically obtains a location for the mitral valve prosthesis that was previously determined, for example, by a clinician. In block 412, the selected mitral valve prosthesis is placed in a 3-D model of the heart at the selected location. For example, the client device 204 generates a 3-D model of the heart with a mitral valve prosthesis included in the 3-D model superimposed. FIGS. 5A-5H show an example of a 3-D model of a heart 500 with a mitral valve prosthesis 511 included in the 3-D model superimposed. The anatomical structures of the heart 500 and the mitral valve prosthesis 511, as discussed, define the neo-LVOT. Certain aspects of the procedure 400 are described using a 3-D model of a heart 500 as an illustrative example.

[0038] In block 414, optionally, a bottom edge of the mitral valve prosthesis in the 3-D model is determined. For example, the mitral valve prosthesis 511 is shown having a bottom edge 520. In certain aspects, the bottom edge is a generally circular or generally elliptical curve. In certain embodiments, the curve may be manually indicated or may be imposed into the data describing the mitral valve prosthesis. For example, a user of a computing device, such as client device 204, may indicate the bottom edge of the mitral valve prosthesis. In some embodiments, the computing device itself may determine the bottom edge using imaging or other techniques. The bottom edge may be the edge of the mitral valve prosthesis 511 that faces / defines the neo-LVOT.

[0039] In block 416, a starting plane is determined that intersects the surface of the mitral valve prosthesis 511 (e.g., the bottom edge of the mitral valve prosthesis 511), at least one point of the neo-LVOT, and at least one point on the patient's anatomical structure (e.g., the left ventricle or the aorta) that defines the boundary of the neo-LVOT in the 3D model of the heart. The starting plane may be determined using manual input by a user of a computing device such as the client device 204, or automatically by a computing device, such as using the 3-D measurement and analysis module 220 (e.g., randomly, or based on the plane of the aortic valve as described below, or by corresponding to the shortest distance between the patient's anatomical structure and the mitral valve prosthesis 511, etc.). The starting plane may correspond to a first plane or starting plane for calculating the area of ​​the neo-LVOT within the neo-LVOT.

[0040] In one embodiment, a starting plane is determined by first determining the plane of the aortic valve of a 3-D model of the heart. The aortic valve plane may be determined on a 3-D model of the heart itself and / or based on an image of the heart, e.g., a 2D image. For example, the aortic valve plane may be determined as a best fit plane through the aortic valve cusps or a plane through multiple points around the aortic valve. In one example, this plane may correspond to plane 522 of heart 500 shown in FIG. 5B. The aortic valve plane may be determined manually by a user of a computing device, such as client device 204, or automatically by a computing device, such as using shape recognition techniques to recognize the aortic valve of the heart. The aortic valve plane may be determined based on a 3-D model of the heart or based on a medical image of the heart.

[0041] In certain embodiments, the starting plane may be determined based on the plane of the aortic valve. For example, in certain embodiments, the plane of the aortic valve may be translated toward the prosthetic mitral valve until it intersects with the prosthetic mitral valve (e.g., the bottom edge of the prosthetic mitral valve). For example, as shown in FIG. 5B, plane 522 is translated or moved along axis 524 (e.g., corresponding to the centerline of the LVOT or neo-LVOT) until plane 522 intersects (e.g., first intersects) bottom edge 520. The resulting plane 526 shown in FIG. 5B may be used as the starting plane. Such translation may be performed automatically by a computer device.

[0042] In certain embodiments, the starting plane may be determined by translating the plane of the aortic valve toward the mitral valve prosthesis until the starting plane abuts the mitral valve prosthesis (e.g., abuts the bottom edge of the mitral valve prosthesis). For example, as shown in FIG. 5C, plane 522 is translated or moved along axis 524a (e.g., corresponding to the centerline of the LVOT or neo-LVOT) until plane 522 abuts bottom edge 520. The resulting plane 526a, shown in FIG. 5C, may be used as the starting plane. Such translation may be performed automatically by a computing device.

[0043] In block 418, multiple cutting planes are generated in addition to the starting plane. For example, the multiple cutting planes may be determined as any plane that intersects a surface of the mitral valve prosthesis 511 (e.g., the bottom edge of the mitral valve prosthesis 511), at least one point of the neo-LVOT, and at least one point on the patient's anatomical structure (e.g., the left ventricle or the aorta) that defines the boundary of the neo-LVOT in the 3-D model of the heart. The multiple cutting planes may be determined by measuring the neo-LVOT from several positions and angles. In certain embodiments, the multiple cutting planes are generated based on the starting plane. The multiple cutting planes may be determined at least in part automatically (e.g., based on a curve (e.g., bottom edge) or a plane of the mitral valve prosthesis, such as the center of a line / plane) by a computing device such as the client device 204, the 3-D measurement and analysis module 220, etc. The user may provide some input, such as the selection of one or more origin points on the starting plane, as discussed herein. The multiple cut planes may correspond to a rotation (and optionally a translation) of the starting plane in one or more directions (e.g., along two different axes perpendicular to each other) around each of one or more origins. For example, FIGS. 5D and 5E show multiple cut planes 528 corresponding to starting plane 526. As shown, starting plane 526 and multiple cut planes 528 intersect the neo-LVOT to define various neo-LVOT areas in various planes of the neo-LVOT. In some embodiments, starting plane 526 is also considered one of multiple cut planes 528. Method embodiments for generating multiple cut planes are further described herein, such as in FIG. 6. The multiple cut planes may correspond to multiple planes for calculating the area of ​​the neo-LVOT within the neo-LVOT.

[0044] At block 420, the area of ​​the neo-LVOT is calculated for each of the multiple cross sections. In some aspects, the area of ​​the neo-LVOT is calculated automatically by a computing device, such as the client device 240, the 3-D measurement and analysis module 220, etc. In some embodiments, the area of ​​the neo-LVOT is calculated for each cross section by subtracting the cross section of the prosthetic mitral valve at that cross section from the cross section of the left ventricle of the 3-D model of the heart at that cross section. The surface area of ​​the resulting cross section is calculated as the area of ​​the neo-LVOT.

[0045] In block 422, the smallest or minimum area of ​​the neo-LVOT among the multiple cross sections is determined. In some embodiments, the minimum area of ​​the neo-LVOT is calculated automatically by a computing device, such as client device 240, 3-D measurement and analysis module 220, etc. For example, computing device 240 compares the area of ​​the neo-LVOT for the multiple cross sections and finds the cross section having the smallest area of ​​the neo-LVOT.

[0046] In block 424, it is determined whether the minimum neo-LVOT area meets a threshold value. In some embodiments, block 424 is performed automatically by a computing device, such as client device 240, 3-D measurement and analysis module 220, etc. In some embodiments, the threshold value is an absolute surface area. In some embodiments, the threshold value is a percentage or ratio threshold value of the minimum neo-LVOT area to the original LVOT area in the cross section having the minimum neo-LVOT area. For example, in some embodiments, the original LVOT area is calculated in the cross section having the minimum neo-LVOT area. In some embodiments, the original LVOT area is calculated automatically by a computing device, such as client device 240. The original LVOT area may be calculated by determining a cross section of the left ventricle of the 3-D model of the heart in the cross section and calculating the surface area of ​​the cross section as the original LVOT area. Thus, the ratio or percentage of the minimum neo-LVOT area to the original LVOT area may be compared to the threshold value.

[0047] At block 424, if it is determined that the minimum neo-LVOT area meets the threshold, the procedure 400 proceeds to block 426. At block 426, the selected mitral valve prosthesis design is finalized. For example, the mitral valve prosthesis design may be output in the form of a selection of a commercially available mitral valve prosthesis, a prescription for a particular mitral valve prosthesis, a custom mitral valve prosthesis design, a CAD file, or the like. In certain embodiments, the mitral valve prosthesis design may be manufactured for a custom mitral valve prosthesis, or the like. In some embodiments, the mitral valve prosthesis design is manufactured by additive manufacturing. In certain aspects, the selected mitral valve prosthesis may be implanted into a patient.

[0048] At block 424, if it is determined that the minimum neo-LVOT area does not meet the threshold, the procedure 400 returns to 408, where a new prosthetic mitral valve design is selected, tested for suitability for mitral valve replacement. In certain embodiments, the new prosthetic mitral valve design may again be manually selected. In certain embodiments, the new prosthetic mitral valve design may be automatically selected or designed by a computing device, such as computing device 204. For example, the previously selected prosthetic mitral valve design may be automatically modified (e.g., one or more dimensions are automatically altered, such as by an increment, within the range of allowed dimensions). The modifications may be performed iteratively until a suitable prosthetic mitral valve design is determined, such that the procedure 400 is performed and a new prosthetic mitral valve design is automatically selected or designed.

[0049] In some embodiments, if it is determined that the minimum neo-LVOT area does not meet the threshold, the procedure 400 may end and no mitral valve replacement may be performed.

[0050] It should be noted that while procedure 400 is described using a single starting plane and multiple cut planes corresponding to the starting plane to determine the minimum area of ​​the neo-LVOT, in certain embodiments, multiple starting planes and multiple cut planes corresponding to the multiple starting planes may be used to determine the minimum area of ​​the neo-LVOT. For example, multiple starting planes may be used that intersect the prosthetic mitral valve design (e.g., the bottom edge of the prosthetic mitral valve, different surfaces of the prosthetic mitral valve design, etc.) at different locations on the prosthetic mitral valve design. In one embodiment, the first starting plane may be based on a plane of the aortic valve that is translated toward the prosthetic mitral valve until it first intersects with the bottom edge of the prosthetic mitral valve. Additional multiple starting planes may be positioned in increments (e.g., 5 degrees) from the first starting plane along the bottom edge over a range (e.g., from -20 degrees to +20 degrees). For example, FIG. 5F shows the spacing of the intersections of multiple starting planes with the bottom edge of the prosthetic mitral valve. In another embodiment, a first starting plane may be selected, and multiple additional starting planes may be located in increments (e.g., 5 degrees, at specific intervals, etc.) in a particular direction from the first starting plane (e.g., along a particular plane, line, surface of a prosthetic mitral valve, neo-LVOT, etc.). In certain embodiments, the multiple starting planes may themselves correspond to the multiple cutting planes generated in block 418.

[0051] 6 is a flow chart illustrating a procedure 600 for generating multiple cutting planes, according to certain embodiments. In certain embodiments, procedure 600 may be used to perform block 418 of procedure 400 of FIG.

[0052] In block 602, an origin is selected on the starting plane. The origin may act as a point around which the starting plane is rotated to generate multiple cut planes. For example, in one embodiment, the origin may be a point on the mitral valve prosthesis (e.g., bottom edge of the mitral valve prosthesis) that the starting plane intersects (e.g., point 530 in FIG. 5G), a point on the patient's anatomy (e.g., left ventricle or aorta) that defines the neo-LVOT that the starting plane intersects (e.g., point 532), or a point within the neo-LVOT that the starting plane intersects (e.g., point 534). In certain embodiments, a user of a computing device, such as client device 204, may indicate the origin. In certain embodiments, the computing device may automatically calculate the origin by finding the intersection between the starting plane and the bottom edge of the mitral valve prosthesis. In certain embodiments, multiple different origins may be selected for the starting plane. That is, procedure 600 may be performed multiple times, once for each origin, to generate multiple cut planes.

[0053] In block 604, a first axis for rotation at the origin is determined. In certain embodiments, the first axis for rotation may be an intersection between the starting plane and a bottom surface of the mitral valve prosthesis, including the bottom edge of the mitral valve prosthesis. For example, FIG. 5D shows an example of a first axis for rotation 536 that is an intersection between the starting plane 526 and a bottom surface 538 of the mitral valve prosthesis. In certain embodiments, a user of a computing device, such as the client device 204, may indicate the first axis for rotation. In certain embodiments, the computing device may automatically determine the first axis for rotation by using imaging techniques to determine the bottom surface 538 and finding the intersection between the starting plane 526 and the bottom surface 538. The first axis for rotation may also be determined in other ways, such as an intersection between the starting plane and a surface, plane, line, etc. of the mitral valve prosthesis.

[0054] In block 606, a second axis of rotation at the origin is determined. In certain embodiments, the second axis of rotation may be a line in the starting plane that passes through the origin and perpendicular to the first axis of rotation. For example, FIG. 5E shows an example of a second axis of rotation 540. In certain embodiments, the computer device may automatically determine the second axis of rotation. By having the second axis of rotation perpendicular to the first axis of rotation, the entire volume in the 3-D space may be quantified with respect to the cross-sectional area.

[0055] At block 608, one or more rotation increments are determined. For example, a single rotation increment (e.g., 1 degree) may be determined for the first axis and the second axis. In another embodiment, different rotation increments may be determined for the first axis and the second axis.

[0056] At block 610, a plurality of cut planes are generated by rotating the starting plane by appropriate rotational increments about one or more of the first axis or the second axis, each cut plane being a rotation at a different increment. For example, in certain embodiments, the starting plane may be rotated by the rotational increments one or more times about the first axis to generate a plurality of cut planes 528, as shown in FIG. 5D. Additionally or alternatively, in certain embodiments, the starting plane may be rotated by the rotational increments one or more times about the second axis to generate a plurality of cut planes 528, as shown in FIG. 5E.

[0057] In certain embodiments, the multiple cut planes are generated by further duplicating one or more cut planes generated in block 610 and translating the one or more cut planes (e.g., along a bottom edge, surface, line, etc. of the mitral valve prosthesis) over one or more distance increments. In certain embodiments, the multiple cut planes are generated by further duplicating one or more cut planes generated in block 610 and translating the one or more cut planes (e.g., along a bottom edge, surface, line, etc. of the mitral valve prosthesis) until the translated one or more cut planes are tangential to the mitral valve prosthesis (e.g., a bottom edge of the mitral valve prosthesis).

[0058] In certain embodiments, the range of rotation within which the starting plane is rotated may be limited based on the 3-D model of the heart and the mitral valve prosthesis. For example, rotation about the first axis may be limited to a range defined by 1) a plane (shown in FIG. 5H as plane 550) through the first axis and a point on the top edge of the mitral valve prosthesis opposite the point where the first axis intersects with the bottom edge, and 2) a plane (shown in FIG. 5H as plane 560) through the first axis and tangent to the top edge of the prosthesis.

[0059] Using the above-described systems and methods, a standardized methodology provides physicians and researchers with the ability to determine the minimum area of ​​a neo-LVOT for transcatheter mitral valve repair research and development, as well as appropriate sizing in the context of a patient and treatment plan. While the above specific examples relate to the mitral valve, those skilled in the art will appreciate that the above principles, systems, and methods may be readily applied in connection with other types of surgical procedures and other regions of the anatomy. For example, in some implementations, the valve may be a pulmonary branch valve, a tricuspid valve, and the like. In other embodiments, the above-described systems and methods may be used to treat pulmonary stenosis, other valves, left atrial appendage (LAA) obstruction, stent grafts for aortic aneurysms, cerebral aneurysm devices, annular assessments (e.g., minimum / maximum area), and the like. In certain embodiments, the described systems and methods may be used for airways, treatment of diseases of the airways, and replacement of prosthetic devices (e.g., stents, grafts, valves, drug delivery systems, and the like) within the airways, and the like.

[0060] It should be understood that any feature described in connection with any one embodiment may be used alone or in combination with the other features described, and may also be used in combination with one or more features of any other embodiment, or in any combination of any other embodiment. Moreover, equivalents and modifications not described above may also be used without departing from the scope of the invention as defined in the appended claims.

[0061] The methods disclosed herein comprise one or more steps or actions for achieving the described method. Method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims. Furthermore, one or more blocks / steps may be deleted or added. For example, only a portion of the procedure 400 illustrated with respect to FIG. 4 and FIG. 4A (e.g., blocks 402-422 for determining the minimum area of ​​the neo-LVOT) may be performed in a particular embodiment.

[0062] Various embodiments disclosed herein provide for the use of a computer system to perform certain features. Those skilled in the art will readily appreciate that these embodiments may be performed using many different types of computer devices, including both general purpose and / or dedicated computer system environments or configurations. Examples of well-known computer systems, environments, and / or configurations that may be suitable for use in connection with the above-described embodiments may include, but are not limited to, personal computers, server computers, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like. These devices may include stored instructions that, when executed by a microprocessor in the computer device, cause the computer device to perform specified operations to execute the instructions. As used herein, instructions refer to computer-executed steps for processing information in a system. Instructions may be executed in software, firmware, or hardware and include any type of programmed steps performed by components of the system.

[0063] The microprocessor may be a conventional general-purpose single-chip or multi-chip microprocessor, such as a Pentium® processor, a Pentium® Pro processor, an 8051 processor, a MIPS® processor, a Power PC® processor, or an Alpha® processor. Additionally, the microprocessor may be any conventional special-purpose microprocessor, such as a digital signal processor or a graphics processor. A microprocessor typically has conventional address lines, conventional data lines, and one or more conventional control lines.

[0064] Aspects and embodiments of the invention disclosed herein may be implemented as a method, apparatus, or article of manufacture using standard programming or engineering techniques to produce software, firmware, hardware, or any combination thereof. As used herein, the term "article of manufacture" refers to code or logic executed in hardware or non-transitory computer readable media, such as optical storage devices, as well as volatile or non-volatile memory devices, such as signals, carrier waves, or transitory computer readable media. Such hardware may include, but is not limited to, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic arrays (PLAs), microprocessors, or other similar processing devices.

Claims

1. 1. A computer-implemented method for determining information regarding a plurality of cross-sectional areas of a passageway of an anatomical structure for fluid flow, comprising: acquiring one or more images of the passageway; placing at least a portion of a representation of a prosthesis in the one or more images of the passageway at a location; determining a starting plane that intersects at least one point on a surface of the representation of the prosthesis at the location, at least one point within a volume defined by the passageway, and at least one point on a boundary of the passageway in the one or more images of the passageway; generating a plurality of cutting planes based on rotating the starting plane one or more times about one or more axes; calculating a plurality of cross-sectional areas corresponding to the plurality of cross-sectional planes, calculating the plurality of cross-sectional areas includes calculating a difference between a first cross-sectional area that is an intersection of the at least a portion of the representation of the prosthetic device at the location with the corresponding cut surface and a second cross-sectional area that is an intersection of the volume with the corresponding cut surface, resulting in the plurality of corresponding cross sections; calculating the surface area of ​​the corresponding cross section obtained as the corresponding cross-sectional area; determining one of a maximum or minimum cross-sectional area of ​​the plurality of cross-sectional areas; comparing one of the maximum cross-sectional area or the minimum cross-sectional area to a threshold; selectively modifying the prosthetic device corresponding to the representation of the prosthetic device based on the comparison.

2. the passageway of the anatomical structure comprises a left ventricular outflow tract (LVOT); the representation of the prosthesis includes a representation of a prosthetic mitral valve; The method of claim 1 , wherein the multiple cross-sectional areas comprise multiple neo-LVOT areas.

3. determining one or more additional starting surfaces; The method of claim 1 , wherein generating the multiple cutting planes is based on rotating each of the one or more additional starting planes one or more times about one or more axes.

4. The method of claim 3 , wherein determining one or more starting planes comprises determining additional starting planes at incremental amounts from the starting plane along the representation of the prosthetic device.

5. the passageway of the anatomical structure comprises a left ventricular outflow tract; the representation of the prosthesis comprises a representation of a prosthetic mitral valve; 2. The method of claim 1, wherein determining the starting plane comprises determining a plane of an aortic valve of the passageway and translating the plane of the aortic valve until it intersects with the representation of the prosthesis at the position.

6. The method of claim 1 , wherein the one or more axes comprises a first axis defined as an intersection between the starting plane and a bottom surface of the representation of the prosthetic device at the location.

7. The method of claim 6 , wherein the one or more axes comprises a second axis defined in the starting plane as a line perpendicular to the first axis.

8. The step of generating a plurality of cutting planes includes: selecting an origin on the starting surface that is one of a first point on a surface of the representation of the prosthesis at the location, a second point on the boundary of the passageway, or a third point within the volume, wherein the one or more axes are defined through the origin; 2. The method of claim 1, further comprising: rotating the starting plane one or more times in increments about at least one of the one or more axes, each of the one or more results corresponding to a cutting plane.

9. The method of claim 8 , wherein the rotating of the starting surface is limited to a range about a first axis of the one or more axes.

10. the surface of the representation of the prosthetic device at the location comprises a bottom edge; the range is defined as between a first surface and a second surface; the first plane is defined through a point on a top edge of the representation of the prosthetic device at the location that is opposite an intersection between the first axis and the bottom edge of the representation of the prosthetic device at the location; 10. The method of claim 9, wherein the second surface is defined to pass through the first axis and be tangent to the top edge of the representation of the prosthetic device at the location.

11. The step of generating a plurality of cutting planes further comprises:

9. The method of claim 8, comprising replicating and translating one or more of the plurality of cutting planes along the surface of the representation of the prosthetic device at the location over one or more distance increments.

12. A non-transitory computer-readable medium having computer-executable instructions stored thereon, comprising: When executed by the one or more processors, causes the one or more processors to perform a method for determining information related to a cross-sectional area of ​​a passageway of an anatomical structure for fluid flow; The method comprises: acquiring one or more images of the passageway; placing at least a portion of a representation of a prosthesis in the one or more images of the passageway at a location; determining a starting plane that intersects at least one point on a surface of the representation of the prosthesis at the location, at least one point within a volume defined by the passage, and at least one point on a boundary of the passage in one or more images of the passage; generating a plurality of cutting planes based on rotating the starting plane one or more times about one or more axes; calculating a plurality of cross-sectional areas corresponding to the plurality of cross-sectional planes, calculating the plurality of cross-sectional areas includes calculating a difference between a first cross-sectional area that is an intersection of the at least a portion of the representation of the prosthetic device at the location with the corresponding cut surface and a second cross-sectional area that is an intersection of the volume with the corresponding cut surface, resulting in the plurality of corresponding cross sections; calculating the surface area of ​​the corresponding cross section obtained as the corresponding cross-sectional area; determining one of a maximum or minimum cross-sectional area of ​​the plurality of cross-sectional areas; comparing one of the maximum cross-sectional area or the minimum cross-sectional area to a threshold; and selectively modifying the prosthetic device corresponding to the representation of the prosthetic device based on the comparison.

13. the passageway of the anatomical structure comprises a left ventricular outflow tract (LVOT); the representation of the prosthesis comprises a representation of a prosthetic mitral valve; The non-transitory computer readable medium of claim 12 , wherein the multiple cross-sectional areas comprise multiple neo-LVOT areas.

14. The method further comprises determining one or more additional starting surfaces; The non-transitory computer readable medium of claim 12 , wherein generating the multiple cutting planes is based on rotating each of the starting planes one or more times about one or more axes.

15. The step of generating a plurality of cutting planes includes: selecting an origin on the starting surface that is one of a first point on the surface of the representation of the prosthesis at the location, a second point on the boundary of the passageway, or a third point within the volume, wherein the one or more axes are defined through the origin; 13. The non-transitory computer readable medium of claim 12, further comprising: rotating the starting plane one or more times in increments about at least one of the one or more axes, each of the one or more results corresponding to a cut plane.

16. 1. A computer system comprising one or more memories and one or more processors, The one or more processors are configured to cause the computer system to perform operations to determine information regarding a cross-sectional area of ​​a passageway of an anatomical structure for fluid flow; The operation is acquiring one or more images of the passageway; placing at least a portion of a representation of a prosthesis in the one or more images of the passageway at a location; determining a starting plane that intersects at least one point on a surface of the representation of the prosthesis at the location, at least one point within a volume defined by the passage, and at least one point on a boundary of the passage in one or more images of the passage; generating a plurality of cutting planes based on rotating the starting plane one or more times about one or more axes; calculating a plurality of cross-sectional areas corresponding to the plurality of cut surfaces, each of the cross-sectional areas corresponding to the plurality of cross-sectional areas; calculating a plurality of cross-sectional areas corresponding to the plurality of cross-sectional planes, The step of calculating the plurality of cross-sectional areas may include calculating a difference between a first cross-sectional area that is an intersection of the at least a portion of the representation of the prosthetic device at the location with the corresponding cut surface and a second cross-sectional area that is an intersection of the volume with the corresponding cut surface, resulting in the plurality of corresponding cross sections; and calculating as the corresponding cross-sectional areas. calculating the surface area of ​​the corresponding cross section obtained as the corresponding cross-sectional area; and determining one of a maximum or minimum cross-sectional area of ​​the plurality of cross-sectional areas; comparing one of the maximum cross-sectional area or the minimum cross-sectional area to a threshold; and selectively modifying the prosthetic device corresponding to the representation of the prosthetic device based on the comparison.

17. the passageway of the anatomical structure comprises a left ventricular outflow tract (LVOT); the representation of the prosthesis comprises a representation of a prosthetic mitral valve; 17. The computer system of claim 16, wherein the multiple cross-sectional areas comprise multiple neo-LVOT areas.

18. The operations further include determining one or more additional starting faces; 20. The computer system of claim 16, wherein generating the multiple cutting planes is further based on rotating each of the additional starting planes one or more times about one or more axes.

19. The step of generating a plurality of cutting planes includes: selecting an origin on the starting surface that is one of a first point on the surface of the representation of the prosthesis at the location, a second point on the boundary of the passageway, or a third point within the volume, wherein the one or more axes are defined through the origin; 20. The computer system of claim 16, further comprising: rotating the starting plane one or more times in increments about at least one of the one or more axes, each of the one or more results corresponding to a cutting plane.

20. The step of generating a plurality of cutting planes further comprises:

17. The computer system of claim 16, further comprising replicating and translating one or more of the plurality of cutting planes along the surface of the representation of the prosthetic device at the position over one or more distance increments.

Images