• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    System and method of mitral valve quantification Systems and methods of mitral valve quantification are described. In one embodiment, a method of mitral valve quantification is provided. The method includes generating a 3D heart model, defining a 3D mitral valve annulus, fitting a plane through the 3D mitral valve annulus, measuring the distance between at least two papillary muscle heads, defining an average diameter of at least one section around the mitral valve annulus, and determining a size of an implant to be implanted.
    公开号:BE1022777A9
    申请号:E20155313
    申请日:2015-05-20
    公开日:2017-02-28
    发明作者:Nicolo Piazza；Peter Verschueren；Todd Pietila
    申请人:Mat Nv；
    IPC主号:
    专利说明:

    System and method of mitral valve quantification
    BACKGROUND OF THE INVENTION
    Field of application of the invention
    This application relates to the quantification of space and volume of zones in the anatomy of a patient. In a number of aspects this application relates in particular to mitral valve quantification. Even more particularly, this application relates to a system and method of quantifying the mitral valve devices and their environment for use in selecting an appropriately sized valve in a catheter-based transcatheter procedure of mitral valve preparation.
    Description of the technology involved
    The human heart is a complex organ with many functional parts that are critical to the proper functioning of the heart and blood circulation throughout the human body. The human heart generally consists of four hollow chambers: the right atrium, the right heart room, the left atrium and the left heart room. 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 done by means of valves. Between the right atrium and the right ventricle there is, for example, an atrioventricular opening.
    The tricuspid valve is located at that opening. It allows blood to flow from the right atrium to the right ventricle. The valve opens when the blood pressure on the side of the atrium is greater than on the side of the ventricle. When the valve opens, blood can flow from the right atrium to the right ventricle. When the blood pressure is greater on the ventricle side, the valve closes. When the valve closes, blood cannot flow back in the other direction.
    In the healthy heart, blood flow is also regulated between the left atrium and the left ventricle. Here, the mitral valve allows blood to enter the left ventricle of the left atrium when the left atrium fills with blood and the blood pressure within the left atrium rises to a level above that of the left ventricle. When the valve is open, blood flows downward from the left atrium to the left ventricle, where it is expelled to the rest of the body as part of the overall circulatory process. When a healthy mitral valve closes, the blood flow between the two chambers is stopped. This closure prevents blood flow reversal.
    Unfortunately, mitral valves do not always work normally. An abnormally functioning mitral valve can lead to serious health problems. One such problem associated with mitral valve is mitral regurgitation ("MR"). Mitral regurgitation is a disorder in which the mitral valve does not close properly during the contraction of the left ventricle. As a result, blood that has flowed from the left atrium in the left ventricle returns to the left atrium.
    Mitral regurgitation can be treated surgically. One surgical option is accompanied by the replacement of the mitral valve in which the mitral valve is replaced by a bioprosthetic or a synthetic replacement valve. Another surgical option is the mitral valve preparation. Although mitral valve preparation is generally considered to be preferable to mitral valve replacement due to the less invasive nature of the procedure, both options require open heart surgery. Because many candidates for mitral valve replacement and repair do not tolerate the stress associated with open heart surgery, permanent research is being conducted into the development of transcathal mitral valve valves. These transcathal mitral valves can be inserted through a catheter-based system, eliminating the need for surgery. Non-invasive catheter-based implantation techniques can minimize physical trauma associated with open heart surgery and effectively treat more patients with mitral regurgitation disorder.
    Although the use of trans-catheter valve valves appears promising, the effective use of these types of devices presents a number of important challenges. With an open surgical procedure, the surgeon has full access to the operated area. He can therefore optically check this zone to carry out the procedure efficiently. However, when using the catheter-based system, the surgeon must rely on various imaging technologies to be guided to repair and / or replace a valve. Since transcatheter mitral valves are inserted using a delivery catheter, it is critical that the transcatheter mitral valve inserted into the patient is of size and shape suitable to fit into the patient's anatomy. The need for adequate size and formation of implants goes beyond mitral valve-related procedures, and can be useful in various surgical conditions. Today, the methodologies for quantifying the pertinent dimensions of the mitral valve are inadequate. Accordingly, there is a need for a standardized measurement method that can be used in planning an implantation of medical devices including the transcatheter implantation of mitral valves.
    Summary
    In one embodiment, a method of mitral valve quantification is provided. The method may include generating a three-dimensional heart model and defining a three-dimensional mitral valve annulus. The method may further include fitting a plane through the three-dimensional mitral valve annulus. The distance between at least two papillary muscle heads can thus be measured. The method may further comprise defining an average diameter of at least one cross-section around the mitral valve annulus. The size of an implant can be selected based on the average diameter.
    In another embodiment, a computer-readable medium is provided on which computer-readable instructions are stored. When the instructions are executed by a processor of a computer device, they can cause the computer device to perform a method of mitral valve quantification. The method may include generating a three-dimensional ("3D") model of a patient's heart based on scanned images of the patient's heart as well as defining a 3D mitral valve annulus. The method may also include fitting a plane through the 3D mitral valve annulus. The distance can be measured between a first papillary muscle head and a second papillary muscle head in the 3D model, and an average diameter of at least one cross-section around the mitral valve annulus can be defined. The method may further include determining the size of an implant to be implanted.
    Brief description of the drawings
    Figure 1 is a block diagram of one example of a computing environment suitable for applying various embodiments described in this text.
    Figure 2 is a high-level system diagram of a computer system that can be used in one or more embodiments.
    Figure 3 is a flow chart illustrating an example of a method of mitral valve quantification in accordance with one or more embodiments.
    Figure 4 is a flow chart of a sub-process illustrating a more detailed view of the anatomical characterization of the mitral valve device of Figure 3 in accordance with one embodiment.
    Figure 5 is a flow chart illustrating an example of a process by which a mitral valve annulus can be defined as described in the process illustrated in Figure 4.
    Fig. 6 is a flowchart illustrating a more detailed view of the imaging enhancement process illustrated in Fig. 4 in accordance with one or more embodiments.
    Figure 7 is a flow chart that provides more details about the distance measurement process described in Figure 4.
    Figure 8A is a flow chart illustrating a sub-process for evaluating the vulnerable anatomical structure referenced in block 310 of Figure 3.
    Figure 8B is a flow chart illustrating an example of how the most suitable size of an implant can be determined in accordance with one or more embodiments.
    Figure 9 is an example of a graphical user interface environment that can be used to define the mitral valve annulus in accordance with the process described in Figure 5.
    FIG. 10-12 provide examples of graphical user interface environments that can be used to calculate the 3D surface area of the mitral valve annulus and to fit a plane through the annulus in accordance with the aspects of the process described in Figure 4.
    Figure 13 is a graphical illustration of open hollow heart anatomy performed in accordance with the aspects of the process described in Figure 6.
    Figure 14 is the open hollow heart anatomy of Figure 13 with various point-to-point measurements defined therein.
    FIG. 15, 16 provide a visual illustration of various aspects of the process described with respect to Figure 8.
    FIG. 17-19C are visual images of graphical user interface environments that can be used to simulate an implant using a primitive form as described in relation to Figure 8B above.
    Detailed description of certain embodiments of the invention
    As described above, determining the appropriate dimensions for an implanted device can play an important role in the success of an implantation procedure. In the context of the trans-catheter mitral valve preparation, the appropriate dimensions and measurement of the device play an important role in the success of a trans-catheter-mitral valve preparation. The inventors have recognized the importance of mitral valve quantification and have designed systems and methods that quantitatively quantify the mitral valve. The systems and methods typically provide for the calculation of a three-dimensional model of blood volume in a patient's heart. Starting from the three-dimensional model, a model of the myocardium and the most important anatomical structures in the heart can also be reconstructed. Using this reconstructed heart, a series of measurements can be performed with which a virtual insertion of a trans-catheter mitral valve device can be simulated by means of three-dimensional computer modeling. Once the device has been implanted virtually within the three-dimensional model of the heart, the surgical zone can be evaluated by analyzing the possible impact of the device on anatomical structures that could be damaged by physical properties of the device. Based on that analysis, a suitably sized mitral valve device can be selected for use in the repair procedure.
    The systems and methods described in this text can be implemented in a computing environment that includes one or more computing devices configured to perform various functionalities. Figure 1 is an example of a computing environment 100 suitable for implementing various embodiments described in this text. The computing environment 100 may include a network 102. The network 102 can take various forms. The network 102 may, for example, be a LAN installed in a surgical zone. In some embodiments, the network 102 may be a WAN such as the Internet, and in other embodiments, the network 102 may be a combination of LANs and WANs. Typically, the network will allow secure communications and data to be shared by different computer devices. These computer devices include a client device 104. The client device 104 may be a typical computer device running commercially available operating systems such as Windows, Mac OS, Linux, Chrome, or any other operating system. Application software may be installed on client device 104 to enable it to interact via network 102 with other software stored on various other modules and devices in computing environment 100. This application software may take the form of a web browser that can access a remote application service. Alternatively, the application software may be a client application installed in the operating system of the client device 104. The client device 104 may also take the form of a specialized computer specifically designed for medical imaging or even more specifically for medical imaging mitral valve quantification. The client device 104 may further take the form of a mobile device or tablet computer configured for communication over the network 102 and further configured for running one or more software modules around a user's different methods described in this text have it carried out.
    The computing environment 100 may further include an image data memory 106. Typically, the image data memory 106 takes the form of a large database designed to store images recorded by a scanning device 112. These images can be DICOM images, or images of a different type. The image data memory 106 may be part of a scanning device 112 or may alternatively be part of a client computer device 104. The image data memory 106 may also be a standalone database with a suitable storage option optimized for medical image data. The computing environment 100 may also include a scanning device 112. The scanning device 112 is typically a medical imaging device that scans a patient to create images of his anatomy. In the computing environment 100 as illustrated in Figure 1, the scanning device 112 may be a CT scanner or an MRI device. However, those skilled in the art will appreciate that other scanning technologies can be implemented that provide imaging data that can be used to create three-dimensional anatomical models.
    As described in more detail in what follows, the scanning device 112 can be configured with a view to creating images of the cross-section of a patient's heart. These images can be stored in the image data memory 106 and can be used to create three-dimensional models of the heart. To that end, the computing environment 100 may also include an image processing module 108. The image processing module 108 may take the form of computer software or hardware, or a combination of both, which retrieves the medical imaging data in the image data memory 106 and which generates a three-dimensional surface model using stacks of two-dimensional image data. The image processing module 108 may be a commercially available image processing software for three-dimensional design and modeling, for example the Mimics application from Matérialisé nv. However, other image processing software can also be used. In a number of embodiments, the image processing module 108 may be provided by means of an internet-based network application that is accessed by a computer via the network (such as, for example, a client device 104). Alternatively, the image processing module may be a software application installed directly in the client device 104 and accessing the image data memory 106 via the network 102. In general, the image processing module 108 may be any combination of software and / or hardware located in the computing environment 100 that provides image processing capabilities on the image data stored in the image data memory 106.
    The computing environment may also include a three-dimensional measurement and analysis module 110 (3D measurement and analysis module). The 3D measurement and analysis module 110 may be software that is complementary and / or bundled with the image processing module 108. The 3D measurement and analysis module 110 may, for example, be a bundled project such as 3matic® from Matérialisé nv. The 3D measurement and analysis module can also take the form of a general CAD software such as, for example, AutoCAD or SolidWorks. In a number of embodiments, the 3D measurement and analysis module may be a specialized application specifically designed for mitral valve quantification. As described in more detail in what follows, the 3D measurement and analysis module 110 will generally be used to make precise measurements of various aspects of the patient's anatomy for the purpose of determining the appropriate dimensions of a patient. surgical implant. In specific examples described below, the anatomy of the heart is measured with a view to determining the appropriate dimensions of a transcatheter implant of a mitral valve. As with the image processing module 108, the 3D measurement and analysis module 110 can be a network-based application to which one or more client devices 104 can access themselves through a web browser. It may also be a proprietary application installed on the operating system of a computer such as, for example, client device 104. In yet other embodiments, the 3D measurement and analysis module 110 may be a network-based application that is implemented as a client / server implementation.
    Various embodiments of the invention can be implemented by means of general or specially designed devices. With reference to Figure 2, an example is illustrated of a computer device 200 suitable for implementing various embodiments of the present invention. The computer system 200 can generally take the form of computer hardware configured to perform certain processes and instructions in accordance with various aspects of one or more embodiments described in this text. The computer hardware can consist of a single computer or multiple computers that are configured to work together. The computer device 200 includes a processor 202. The processor 202 may also be one or more standard PC processor such as that designed and / or distributed by Intel, Advanced Micro Devices, Apple, ARM, or Motorola. The processor 202 may also be a more specialized processor specifically designed for image processing and / or analysis. The computer device 200 may also include a display 204. The display 204 may be a standard computer monitor such as an LCD monitor, as known in the art. The display 204 can also take the form of a display integrated into the body of the computer device, for example a one-piece computer device or a tablet computer.
    The computer device 200 may also include input / output devices 206. This can be standard peripheral equipment such as keyboards, mice, printers and other basic input / output software and hardware. The computer device 200 may further comprise a memory 208. The memory 208 can take various forms. By way of example, the memory 208 may contain volatile memory 210. The volatile memory 210 can be any form of RAM, and can generally be configured for loading executable software modules into the memory, so that the software modules can be executed by the processor 202 on a computer known manner. The software modules can be stored in the permanent memory 212. The permanent memory 212 can take the form of a hard disk, a flash memory, a fixed hard disk or any other form of permanent memory. The permanent memory 104B can also be used to store non-executable data, such as data files and the like.
    The computer device 200 may also include a network interface 214. The network interface may take the form of a network interface card and its corresponding software drivers and / or firmware configured to allow the system 200 to access a network (such as the internet, for example). The network interface card 214 may be configured for accessing different network types, for example as described above with respect to Figure 1. The network interface card 214 may be configured for accessing private networks that are not accessible to public. The network interface card 214 may also be configured for accessing wireless networks using wireless transfer technologies such as EVDO, WiMax, or LTE network. Although only a single network interface is illustrated in Figure 2, multiple network interface cards 214 may also be present to access different network types. In addition, a single network interface card 214 may be configured for accessing different network types. in general, the computing environment 100 as illustrated in Figure 1 may generally include one, single, or many types of computing devices 200 cooperating to perform various embodiments described below. Those skilled in the art understand that various types of computer devices and network configurations can be implemented to implement the systems and method of the invention described in this text.
    Figure 3 is a high-level system diagram illustrating a process by which the quantification of space and / or volume of a specific zone of a patient's anatomy, in this example the mitral valve, can be realized in accordance with one or more embodiments. The process starts at block 302, where an image of the patient's heart is recorded. The image can be obtained by means of the scanning device 112, for example a CT scanner or an MRI machine. In the image registration, a contrast means can be used to improve the visibility of various internal structures of the heart. The image (s) recorded by the scanning device 112 can be stored in the image data memory 106 or in any other via the computer network 102 accessible computer memory. The process then proceeds to block 304. There, a 3D model of blood volume is calculated based on the registered image. The use of a contrast medium in the previous step allows the 3D modeling of blood volume. The 3D model can be calculated using the image processing module 108 or any other software and / or hardware designed to generate 3D models based on CT and / or MRI image data.
    By means of the 3D model of blood volume, the anatomical structures of the heart can be reconstructed in block 306. Typically, it is easier to first obtain the blood volume of the clearly visible contrast agent and then use it to create the myocardium. Those skilled in the art will understand, however, that it is also possible to directly create the myocardial model. This reconstruction can also be performed using the image processing module 108. The reconstruction of the anatomy of the heart typically begins with the segmentation of the left side of the heart, followed by the optimization of the segmented and reconstructed 3D model using optimization tools such as winding and softening functions to clean the surfaces of the models.
    The process then proceeds to block 308. There, the anatomy of the mitral valve device is characterized by defining check points and making measurements of relevant anatomical structures. Typically, these measurements are performed using the 3D measurement and analysis module 110. As described above, the 3D measurement and analysis module 110 may be software bundled with, or even integrated into, the image processing module 108. These measurements may consist of different steps. For example, using the 3D measurement and analysis module 110, check points can be placed on the 3D model of the heart that define the mitral valve annulus. The control points can be defined using a spline-drawing functionality provided by the 3D measurement and analysis module 110.
    If the mitral valve annulus is defined, the measurements may further include the calculation of the 3D surface zone of the mitral valve annulus based on the spline. With regard to the mitral valve annulus, additional measurements and analyzes can be performed. By way of example, and as will be explained in the following, one or more planes can be fitted through the mitral valve annulus using the 3D measurement and analysis module. Using these defined planes, additional measurements can be performed that contribute to a more accurate definition of the actual geometry of the mitral valve annulus.
    Once the measurements have been made, the process proceeds to block 310. There, an evaluation is made of vulnerable anatomical structures. An anatomical structure can be fragile because a trans-catheter implant of a mitral valve typically cannot be attached within the mitral valve. Rather, the mitral valve device will experience a high degree of mobility. This movement can potentially damage surrounding anatomical structures due to collisions or protrusions of the device. This analysis can be performed on the basis of measurements made in the previous step. In addition, a visual check can be performed. Finally, based on the measurements taken and the vulnerabilities evaluated, a suitable sized mitral valve device can be selected in block 312.
    As previously described with respect to block 308 of Figure 3, the mitral valve quantification process in certain embodiments may include characterizing the anatomy of the mitral valve device. Figure 4 is a flow chart of one example of a sub-process that can be implemented to characterize the anatomy provided in block 308. The subprocess starts in block 401 where the mitral valve annulus is defined in the reconstructed model of the heart by means of the image processing module. Additional details on how the mitral valve annulus is defined will be discussed below with reference to Figure 5. Once the mitral valve annulus is defined, the process proceeds to block 403. There, the 3D surface area of the mitral valve annulus is calculated. The process then proceeds to block 405 where a face is fitted through the 3D mitral valve annulus. In a number of embodiments, the plane can be generated by using a create reference plane function provided by the image processing module 108 and / or the 3D measurement and analysis module 110. When fitting the plane through the mitral valve annulus, the 3D mitral valve annulus surface zone (the mitral surface) are used as a fitting entity.
    The process then proceeds to block 407. Here, the imaging of the 3D model is improved by adding additional anatomical details to the model and generating an illustration of a hollow heart anatomy. Additional details about this imaging enhancement will be discussed below with reference to Figure 6. Once the imaging of the 3D model is improved, the process proceeds to block 409. In block 409, distance measurements are performed on the model to determine different size attributes. which may have an influence on the size of the mitral valve transcatheter implant. These distance measurements can be performed against various aspects of the 3D model, and will be discussed below with reference to Figure 8.
    As described above, Figure 5 is a flow chart that provides additional details about the process by which a mitral valve annulus can be defined in the 3D model. In this specific example, the mitral valve annulus can be defined by first placing control points on a user interface that graphically represents the 3D model of the heart to the user. The control points can be placed using a spline-drawing functionality provided by the 3D measurement and analysis module 110. Once each of the control points for the defined mitral valve annulus are selected, the initial control point can be selected to block the spline in block 504 to close. Once the spine is closed, the process can proceed to block 506 where the check points can be verified and edited based on reformatted views generated from the data initially recorded by the scanning device 112. The control points selected by the user can be placed, for example, on any of a coronal reformation, a sagittal reformation, and a conventional axial view. If the check points are not consistent with the anatomy illustrated in any of the reformatted views, they can be edited to ensure that they are consistent with the originally recorded image data. If the checkpoints are consistent with the anatomy illustrated in the reformatted views, the process can proceed to block 508 where the spline object is stored and exported for use in the 3D heart model.
    With reference to Figure 6, a more detailed flow chart is provided that provides additional details about the image enhancement of block 407 and Figure 4. In particular, Figure 6 provides an example of one implementation of the image enhancement process in accordance with one embodiment. The process starts at block 601, where a wall thickness is added to the 3D heart model. Since the original 3D heart model was generated using blood volume images, these images do not provide data about the wall thickness in the model. In a number of embodiments, the wall thickness can be added by applying a hollow machining to the heart model and specifying a wall thickness as an element of that machining. Once the wall thickness has been added, the process can proceed to block 603 where a heart-intersecting surface can be defined. In a number of embodiments, the plane can be used for a section of the anatomy to provide an inside view of the geometry of the left half of the heart. In one embodiment, a three-point method can be implemented to define the plane that intersects the septum and the rising aorta. However, those skilled in the art will appreciate that the precise location of the points can be changed and that other methods can be used to obtain an image of the internal geometry. Once the plane that intersects the heart is defined, a blocking function can be performed on the hollow heart at block 605. When performing the cutting function on the hollow heart, the defined plane on the septum can be used as a cutting entity. The use of the cutting function results in a cut-away view of the inside of the anatomy of the heart.
    Figure 7 is a more detailed flow chart of the distance measurement step shown in block 409 of Figure 4. In this example, various distance measurements can be performed using the 3D measurement and analysis module 110. In this specific example, the process starts at block 702 where the distance between papillary muscle heads is measured. Using the 3D measurement and analysis module 110, a user can identify and select two points in the cut-away view generated by the cutting function performed in Figure 6. Both of these selected points can match any of the papillary muscle heads. The 3D measurement and analysis module 110 can determine the distance between the papillary muscle heads based on these two points.
    The process then proceeds to block 704. There, the distance is calculated between each of the papillary muscle heads and the mitral plane. In this specific example, the distance is calculated, normal to the mitral plane, and not to the geometric center of the plane. Additional measurements can also be performed. The process then proceeds to block 706 where the distance between the papillary muscle heads and the geometric center of the mitral valve annulus is calculated. The process then proceeds to block 708 where the distance between the center point and the geometric center of the mitral valve annulus is determined. The process then proceeds to block 710 where the distance between the left atrium roof and the geometric center of the mitral valve annulus is calculated.
    These distance measurements can be used to select an implant design that avoids collisions with different anatomical structures after implantation. A transcatheter implant of a mitral valve can contain various metal components. After implantation in the mitral valve annulus, it exhibits a specific height and shape. The height and shape of the implanted device can interact significantly with different anatomical structures in the patient. For example, on the atrial side, the implant may collide with and damage the thin walls of the atrium. In particular, the circumference of the implant may possibly perforate the atrium wall due to its high mobility and the deformation between systole and diastole. Moreover, on the ventricular side, the deformations are also quite large, and the papillary muscles can interfere with the valves on the device by pushing against the frame of the valve. Moreover, they can even interfere with the new valve blades that are sewn into the metal structure. That would mean that the new valve could not open or close, or wear out even faster due to this repeated mechanical contact. Accordingly, the distance measurements can be analyzed to take into account the mobility of the device and to choose a size that avoids these problems.
    With reference to Figure 8A, a more detailed flow chart is provided which gives an example of a detailed process for evaluating vulnerable anatomical structures as illustrated in Figure 3. This sub-process starts at block 801. Using the 3D measurement and analysis module 110 allows a user to make the sections of the anatomy, both above and below the mitral valve face. In a number of embodiments, the translation function can be used to copy the mitral valve surface above and below the mitral valve annulus. In one specific implementation, the surface can be translated in steps of 5 mm to 20 mm.
    The process then proceeds to block 803 where the circumference of the lumen (e.g., the mitral valve) is recorded in each section created by the translation function. In a number of embodiments, an intersection curve can be calculated between the blood volume anatomy provided by a 3D model and each plane to record the circumference of the lumen in each section. The process then proceeds to block 805, where the system can extract the average diameter measurements on each of the cross-sections. In one embodiment, the average diameter measurements can be extracted by an arc method or any other function that can be used to create an arc or curve.
    As described above with respect to Figure 3, after the vulnerable anatomical structures have been evaluated, the appropriate size for a mitral valve transcatheter implant is determined. Figure 8B is an example of a process by which the most suitable size can be selected in accordance with one or more embodiments. The process starts at block 811, where a primitive cylinder can be generated to simulate the implant. The primitive cylinder can be indirectly generated based on the measurements determined in combination with Figure 7, and more directly based on the recorded circumference of the mitral valve annulus lumen as obtained using the process as described above with respect to Figure 8A. Once the primitive cylinder has been generated, the process proceeds to block 813 where the implant is verified by visualizing the outlines of the object superimposed on the original scanned images. Although the primitive form generated in this example is a cylinder, those skilled in the art understand that any number of other primitive forms can be used individually or in combination with the cylinder.
    Although the general process as described above with reference to Figure 3 and the sub-processes described with reference to Figures 4-8B can be performed using various different configurations of computer hardware and / or software, Figures 9-14 illustrate examples of graphic user interfaces and computer-generated images that can be used in the execution of the described process.
    Referring to Figure 9, an example is provided of a graphical user interface environment that can be used to define the mitral valve annulus as described above with respect to Figure 5. As illustrated, a 3D surface model of the left side of the heart of the heart is provided. patient. On the 3D surface model of the heart 900 a spline 906 is laid, created by means of a spline-drawing functionality provided by the image processing module 108. The spline 406 defines the mitral valve annulus and is created by the user entering the control points which surround the spline by selecting the initial checkpoint.
    Figures 10-12 are an example of a graphical user interface environment that can be used to calculate the 3D surface area of the mitral valve annulus and fit a plane through the annulus as previously described in blocks 403 and 405 of Figure 4. Figure 10 illustrates how the 3D surface zone of the mitral valve annulus is displayed. As illustrated, reference is made to the mitral valve annulus surface area 1002 and various properties 1004, including the calculated surface area 1006, are shown. The calculated surface zone 1006 can be used to calculate the size of the implant device. In addition to the calculated surface zone, the projected circumference of the annulus or a combination of other measurements can also play a role in the final determination of the most suitable device.
    Figures 11A and 11B are graphical representations of aspects of a user interface with which a plane can be fitted through the mitral annulus using a create reference plane function. As illustrated, a create reference plane operation 1102 was selected. A fit plane method 1104 for creating the reference plane was selected, and fitting entity 1106 was selected. In this specific case, the mitral surface of Figure 10 was selected as the fitting entity. Figure 11B provides a graphic illustration of how the plane is fitted to the 3D heart model. As illustrated, a plane was fitted through the mitral annulus, with the geometric center 1108 of the mitral valve annulus as the origin of the fitted plane 1110.
    As described above with reference to Figure 6, a wall thickness can be added to the 3D heart model and a plane defined that intersects the heart and where a cross-section can then be taken to obtain a hollow heart anatomy. Referring to Figure 12, a graphic illustration shows how the intersecting surface can be defined. Here, by means of a three-point method, the intersecting surface 1203 is defined which intersects the interventricular septum 1205 (separating the left ventricle from the right ventricle) and the rising aorta 1207.
    Figure 13 is a cutaway view 1302 of the 3D heart model after the cutting function was performed on the hollow heart anatomy as previously described at block 605 of Figure 6. As previously described with reference to Figure 6, in this specific example, the defined plane as shown illustrated in Figure 12 used as a cutting entity.
    Figure 14 provides a visual illustration of how the various measurements described in Figure 7 can be performed in a graphical user interface environment. Figure 14 shows the cut-away view 1302 of Figure 13. The cut-away view 1302 shows various measurements that were extracted by means of a point-to-point measurement tool. Different measurements are shown relative to the geometric center 1403 of the mitral annulus. Other measurements include the distance between the papillary muscle heads (37.42 mm), the distance from the papillary muscle heads to the mitral plane (18.02 mm and 13.99 mm), the distance from the papillary muscle heads to the geometric center of the mitral valve annulus ( 26.12 mm and 23.16 mm), and the distance from the apex of the left ventricle to the geometric center of the mitral valve annulus (110.21 mm).
    Referring to Figures 15 and 16, a visual illustration of the process described in Figure 8A is provided. As illustrated, a translation triple measurement and analysis module 110 was used to copy the mitral valve plane above and below the mitral valve annulus. The plane is translated in steps of 5 mm to 20 mm, as evidenced by the values in the distance field 1506 and the number of copy field 1508. As described above in Figure 8A, an intersection curve can be calculated between the blood volume anatomy 302 and each plane 1505 wherein the circumference of the lumen is recorded in each section. Referring to Figure 16, a graphic illustration is provided of how the average diameter measurement is extracted for each cross-section. As described above, these measurements on these cross-sections can be extracted by an arc method.
    Figure 17 provides a visual illustration of one graphical user interface environment that can be used to simulate an implant using a primitive cylinder as previously described with reference to Figure 8B. As illustrated, the mitral cancellation curve 1702 is projected into the plane 1704 that is fitted by the mitral annulus. The mitral annulus curve was exported, resulting in a flattened annulus 1706 and the diameter of the flattened annulus can be measured and used to determine the size of the primitive implant.
    Figures 18A and 18B are examples of a graphical user interface that can be used to create a simulated implant using a primitive cylinder. As illustrated in Figure 18A, the create cylinder operation is applied in the 3D measurement and analysis module 110 using the measurements obtained as previously described. Figure 18B illustrates the generated cylinder 1801 positioned within the mitral valve annulus.
    In some embodiments, the cylinder or any other geometry (e.g., primitive shape, CAD or scan file of the device as described above) can be implanted "virtually" as illustrated in Figure 19A. Here, a distance mapping can be performed with regard to the anatomy. This distance mapping can quantify the space available between the implanted device and any relevant part of the anatomy. As illustrated, a primitive form 1902 (in this example a cylinder, but can take various other forms) was virtually placed in the mitral valve annulus. With reference to Figure 19B, distance mapping was used to identify the position of anatomical structures in the heart (e.g., the walls of the atrium) or other anatomical features 1908, as illustrated in Figure 19C. The distance mapping provides a clear visualization of the space around the proposed implant.
    Using the systems and methods described above, a standardized method offers physicians and researchers the opportunity to quantify the mitral valve device and its environment for research and development in the field of transcathal mitral valve preparation, and to determine the appropriate size in a context of planning for patient and procedure. Although the specific examples described relate to mitral valve quantification, those skilled in the art understand that the principles, systems and methods described above can be easily applied to other types of surgical procedures and other areas of anatomy. For example, in some embodiments, the valve may be a pulmonary valve. In other embodiments, the principles and methods described above can be used in the treatment of pulmonary valve stenosis. In other implementations, a measurement and quantification of holes resulting from congenital heart disorders such as the atrial septal defect (ASD) or the ventricular septal defect (VSD) can also be performed to determine a suitable size for a catheter implant or other device to be implanted.
    It should be understood that any feature with respect to any embodiment may be used alone or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. In addition, equivalents and modifications not previously described can also be implemented without departing from the scope of the invention which is defined in the appended claims.
    权利要求:
    Claims (24)
    [1]
    A method for quantifying a valve in an organ, the method comprising: generating a three-dimensional ("3D") model of the organ based on scanned images of the organ; defining a 3D valve annulus; fitting a plane through the valve annulus; measuring the distance between a first location and a second location in the 3D model; defining an average diameter of at least one cross-section around the valve annulus; and determining the size of an implant to be implanted.
    [2]
    The method of claim 1, wherein the valve is a mitral valve and the organ is the heart of a patient, wherein measuring the distance between the first location and the second location is accompanied by measuring the distance between a first papillary muscle head and a second papillary muscle head in the 3D model.
    [3]
    The method of claim 1, wherein the generating of the 3D model comprises: obtaining an image of the patient's heart; calculating a 3D model of blood volume; and reconstituting the patient's heart using the calculated model.
    [4]
    The method of claim 1, wherein defining the mitral valve annulus comprises: placing control points on the 3D heart model, wherein the control points define the mitral valve annulus; verifying the control points using reformatted views of the patient's heart; and exporting the check points for use in the 3D model.
    [5]
    The method of claim 4, wherein the check points include a spline and wherein the spline is defined by selecting the check points.
    [6]
    The method of claim 1, wherein measuring the distance between the first papillary muscle head and the second papillary muscle head comprises: adding the wall thickness to the 3D model; defining a plane that intersects the septum and a rising aorta of the patient's heart; performing a cutting function to obtain a cut-away view of the anatomy of the patient's heart; performing the measurement using a point-to-point measurement tool.
    [7]
    The method of claim 1, the method further comprising: measuring the distance of at least one papillary muscle head to the fit surface; measuring the distance from at least one papillary muscle head to a geometric center of the defined mitral valve annulus; measuring the distance of a ventricular apex from the patient's heart to the geometric center of the defined mitral valve annulus; measuring the distance from a left atrium roof to the geometric center of the defined mitral valve annulus.
    [8]
    The method of claim 1, wherein determining the size of an implant to be implanted comprises: generating a primitive shape to simulate the implant; and verifying the cylinder by placing the generated cylinder on the scanned images of the patient's heart.
    [9]
    The method of claim 8, wherein the scanned images of the patient's heart are at least one of CT images and MRI images.
    [10]
    The method of claim 1, wherein defining an average diameter of at least one cross-section about the mitral valve annulus comprises: defining a mitral valve surface; making sections of the anatomy, both above and below the mitral valve surface; registering a circumference of the lumen in each section; and extracting average measurements for each cross-section.
    [11]
    The method of claim 10, wherein the average measurements are extracted using at least one of an arc method, a circle fit, an ellipse fit, and a free line segment fit.
    [12]
    The method of claim 1, wherein the valve is a pulmonary valve.
    [13]
    A computer-readable storage medium on which computer-readable instructions are stored which, when executed by a processor of a computer device, cause a computer device to perform a method of mitral valve quantification, which method comprises: generating a three-dimensional ( "3D" model of the organ based on scanned images of the organ; defining a 3D valve annulus; fitting a plane through the valve annulus; measuring the distance between a first location and a second location in the 3D model; defining an average diameter of at least one cross-section around the valve annulus; and determining the size of an implant to be implanted.
    [14]
    The computer-readable medium of claim 13, wherein the valve is a mitral valve and the organ is the heart of a patient, wherein measuring the distance between the first location and the second location is accompanied by measuring the distance between a first papillary muscle head and a second papillary muscle head in the 3D model.
    [15]
    The computer-readable medium of claim 14, wherein the generating of the 3D model comprises: obtaining an image of the patient's heart; calculating a 3D model of blood volume; and reconstituting the patient's heart using the calculated model.
    [16]
    The computer-readable medium of claim 14, wherein defining the mitral valve annulus comprises: placing control points on the 3D heart model, wherein the control points define the mitral valve annulus; verifying the control points using reformatted views of the patient's heart; and exporting the check points for use in the 3D model.
    [17]
    The computer-readable medium of claim 16, wherein the check points include a spline and wherein the spline is defined by selecting the check points.
    [18]
    The computer-readable medium of claim 14, wherein measuring the distance between the first papillary muscle head and the second papillary muscle head comprises: adding the wall thickness to the 3D model; visualizing the anatomy of the heart; performing the measurement using a point-to-point measurement tool.
    [19]
    The computer-readable medium of claim 14, further comprising: measuring the distance of at least one papillary muscle head from the fit surface; measuring the distance from at least one papillary muscle head to a geometric center of the defined mitral valve annulus; measuring the distance of a ventricular apex from the patient's heart to the geometric center of the defined mitral valve annulus; measuring the distance from a left atrium roof to the geometric center of the defined mitral valve annulus.
    [20]
    The computer-readable medium of claim 14, wherein determining the size of an implant to be implanted comprises: generating a primitive cylinder to simulate the implant; and verifying the primitive cylinder by visualizing the generated cylinder superimposed on the scanned images of the patient's heart.
    [21]
    The computer-readable medium of claim 20, wherein the scanned images of the patient's heart are at least one of CT images and MRI images.
    [22]
    The computer-readable medium of claim 14, wherein defining an average diameter of at least one cross-section about the mitral valve annulus comprises: defining a mitral valve surface; making sections of the anatomy, both above and below the mitral valve surface; registering a circumference of the lumen in each section; and extracting an average diameter measurement for each cross-section.
    [23]
    The computer-readable medium of claim 22, wherein the average diameter measurements are extracted by an arc method.
    [24]
    The computer-readable medium of claim 13, wherein the valve is a pulmonary valve.
    类似技术:
    公开号 | 公开日 | 专利标题
    BE1022777A9|2017-02-28|System and method of mitral valve quantification
    US11004198B2|2021-05-11|Method and system for assessing vessel obstruction based on machine learning
    De Craene et al.2012|Temporal diffeomorphic free-form deformation: Application to motion and strain estimation from 3D echocardiography
    Wang et al.2009|Modelling passive diastolic mechanics with quantitative MRI of cardiac structure and function
    US10970829B2|2021-04-06|Synthesizing and segmenting cross-domain medical images
    Kozic et al.2010|Optimisation of orthopaedic implant design using statistical shape space analysis based on level sets
    JP6382304B2|2018-08-29|Medical imaging system
    EP3444781B1|2020-03-18|Image processing apparatus and image processing method
    EP3667615A1|2020-06-17|Determination of metastases in an image of an anatomical body part
    Kjer et al.2018|Patient-specific estimation of detailed cochlear shape from clinical CT images
    García et al.2018|A step‐by‐step review on patient‐specific biomechanical finite element models for breast MRI to x‐ray mammography registration
    Cuadros Linares et al.2019|Mandible and skull segmentation in cone beam computed tomography using super-voxels and graph clustering
    US10335238B2|2019-07-02|System and method for non-invasively estimating electrophysiological maps and measurements from cardio-thoracic 3D images and electrocardiography data
    Kjer et al.2016|Free-form image registration of human cochlear μCT data using skeleton similarity as anatomical prior
    Le et al.2019|High resolution simulation of diastolic left ventricular hemodynamics guided by four-dimensional flow magnetic resonance imaging data
    Matsopoulos et al.2005|Thoracic non-rigid registration combining self-organizing maps and radial basis functions
    Vera et al.2019|An automatic technique for left ventricle segmentation from msct cardiac volumes
    Lu et al.2015|Facial nerve image enhancement from CBCT using supervised learning technique
    Złahoda-Huzior et al.2019|Automatic aorta and left ventricle segmentation for TAVI procedure planning using convolutional neural networks
    Bravo et al.2010|Left ventricle segmentation and motion analysis in multislice computerized tomography
    Umenhoffer et al.2018|Modeling and simulation framework of aortic valve for hemodynamic evaluation of aortic root replacement surgery outcomes
    Ün et al.2019|An analytical method to create patient-specific deformed bone models using X-ray images and a healthy bone model
    Niemann et al.2020|Shrinking tube mesh: combined mesh generation and smoothing for pathologic vessels
    Baličević et al.2018|A computational model-based approach for atlas construction of aortic Doppler velocity profiles for segmentation purposes
    JP2021086263A|2021-06-03|Image processing apparatus, image processing method, and program
    同族专利:
    公开号 | 公开日
    JP2017515609A|2017-06-15|
    US10546378B2|2020-01-28|
    WO2015179543A1|2015-11-26|
    CA2949686C|2019-03-19|
    US20190043191A1|2019-02-07|
    JP6333413B2|2018-05-30|
    US10127657B2|2018-11-13|
    US20170084029A1|2017-03-23|
    EP3146507A1|2017-03-29|
    BE1022777B1|2016-09-01|
    BE1022777A1|2016-09-01|
    US20200051243A1|2020-02-13|
    CA2949686A1|2015-11-26|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    EP1832233A4|2004-12-24|2008-04-16|Yd Ltd|Cardiac valve data measuring method and device|
    CN102245120B|2008-12-12|2014-08-13|皇家飞利浦电子股份有限公司|Automatic road mapping for heart valve replacement|
    CN102438551A|2009-05-08|2012-05-02|皇家飞利浦电子股份有限公司|Ultrasonic planning and guidance of implantable medical devices|
    US8812431B2|2010-02-03|2014-08-19|Siemens Aktiengesellschaft|Method and system for medical decision support using organ models and learning based discriminative distance functions|
    US8920322B2|2011-03-09|2014-12-30|Siemens Aktiengesellschaft|Valve treatment simulation from medical diagnostic imaging data|
    JP6382304B2|2013-06-07|2018-08-29|コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ．|Medical imaging system|
    US10881461B2|2014-08-07|2021-01-05|Henry Ford Health System|Method of analyzing hollow anatomical structures for percutaneous implantation|US5364914A|1988-10-05|1994-11-15|Imperial Chemical Industries Plc|Moulding composition comprising a thermoset component and thermoplast component|
    US9058692B1|2014-04-16|2015-06-16|Heartflow, Inc.|Systems and methods for image-based object modeling using multiple image acquisitions or reconstructions|
    US10881461B2|2014-08-07|2021-01-05|Henry Ford Health System|Method of analyzing hollow anatomical structures for percutaneous implantation|
    US9693830B2|2014-12-10|2017-07-04|Henry Ford Health System|Evaluating prosthetic heart valve placement|
    DE102016119620A1|2016-10-14|2018-04-19|Fehling Instruments Gmbh & Co. Kg|Teaching for the reconstruction of a sail of an aortic valve|
    WO2018089461A1|2016-11-08|2018-05-17|Henry Ford Health System|Selecting a medical device for use in a medical procedure|
    CA3055394A1|2017-03-07|2018-09-13|Cd Med S.R.L.|Method for generating a mitral repair ring, and mitral repair ring|
    USD878414S1|2017-04-19|2020-03-17|Navix International Limited|Display screen or portion thereof with icon|
    US10499879B2|2017-05-31|2019-12-10|General Electric Company|Systems and methods for displaying intersections on ultrasound images|
    KR20190002958A|2017-06-30|2019-01-09|연세대학교 산학협력단|A method for decting a left atrial appendage using a geometric information of a heart|
    US10388015B2|2017-09-06|2019-08-20|International Business Machines Corporation|Automated septal defect detection in cardiac computed tomography images|
    USD918929S1|2017-09-28|2021-05-11|Navix International Limited|Display screen or portion thereof with panoramic view|
    USD878413S1|2017-09-28|2020-03-17|Navix International Limited|Display screen or portion thereof with icon|
    US10595994B1|2018-09-20|2020-03-24|Vdyne, Llc|Side-delivered transcatheter heart valve replacement|
    US11071627B2|2018-10-18|2021-07-27|Vdyne, Inc.|Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis|
    US11109969B2|2018-10-22|2021-09-07|Vdyne, Inc.|Guidewire delivery of transcatheter heart valve|
    CN111432718A|2018-11-09|2020-07-17|亨利福特保健系统|Assessing blood flow blockage through anatomical structures|
    US11253359B2|2018-12-20|2022-02-22|Vdyne, Inc.|Proximal tab for side-delivered transcatheter heart valves and methods of delivery|
    US11185409B2|2019-01-26|2021-11-30|Vdyne, Inc.|Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis|
    US11173027B2|2019-03-14|2021-11-16|Vdyne, Inc.|Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same|
    US11076956B2|2019-03-14|2021-08-03|Vdyne, Inc.|Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis|
    EP3962397A1|2019-05-01|2022-03-09|Materialise NV|System and method of fluid passageway cross-sectional area determination in an anatomy|
    AU2020267390A1|2019-05-04|2021-11-11|Vdyne, Inc.|Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus|
    WO2021035032A1|2019-08-20|2021-02-25|Vdyne, Inc.|Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves|
    US11234813B2|2020-01-17|2022-02-01|Vdyne, Inc.|Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    US201462001016P| true| 2014-05-20|2014-05-20|
    US62/001,016|2014-05-20|
    [返回顶部]