Left atrial appendage closure pretreatment system and method

Abstract

The present disclosure teaches that determining a recommended LAA closure device size is based on simulating the deployment of multiple closure devices using the LAA anatomy. An input image of a patient's LAA anatomy is received. Multiple simulations are performed to provide device interaction, closure, and fixation options for multiple fixation locations and device sizes. Gaps between the simulated deployed devices are analyzed based on leak paths and a recommended closure device size is determined based on the simulated gaps.

Description

[Technical Field]

[0001] The present disclosure relates generally to left atrial appendage (LAA) closure procedures. Specifically, but not exclusively, the present disclosure relates to pre-planning the size and placement of an LAA closure device. [Background technology]

[0002] The human left atrial appendage (LAA) is highly variable in size and shape among patients, making it difficult for physicians to determine the appropriate size and deployment location of an LAA closure device. Computed tomography (CT)-based pre-planning allows physicians to evaluate a patient's LAA prior to the procedure. However, available CT-based pre-planning tools provide limited information. Therefore, there is a need for more advanced pre-planning tools than those currently available. Summary of the Invention [Problem to be solved by the invention]

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0004] The present disclosure provides LAA closure pre-planning methods and systems that address shortcomings of conventional solutions, such as pre-planning methods and systems that can provide important information to physicians, such as the interaction between the closure device and the LAA, the sealing of the closure device, and the fixation of the closure device. [Means for solving the problem]

[0005] Generally, the present disclosure provides for receiving as input an image of a patient's LAA anatomy (e.g., from CT-based pre-procedure imaging). Multiple simulations are performed to provide device interaction, closure, and fixation options for multiple fixation locations and device sizes. In some examples, based on the simulated LAA interaction, sealing, and fixation results, the simulation may provide a recommendation for an ideal closure device size.

[0006] In some examples, the present disclosure provides a method for pre-planning LAA closure, the method including receiving an image including a representation of a patient's LAA, receiving a representation of a landing zone of a closure device, simulating deployment of the closure device within the patient's LAA, simulating sealing of the deployed closure device relative to the patient's LAA, simulating fixation of the closure device within the patient's LAA, and generating a graphical representation of the sealing and fixation of the closure device within the patient's LAA.

[0007] The method may further comprise generating a graphical representation of a deployed closure device within the patient's LAA. In some implementations, generating a graphical representation of a deployed closure device within the patient's LAA comprises overlaying a simulated deployed closure device with a graphical representation of the patient's LAA. The method may further comprise determining a recommended closure device size based on the received image. The method may further comprise identifying an ostial diameter of the patient's LAA based on the received image, selecting a closure device size from a set of closure device sizes that is within a threshold dilated diameter relative to the ostial diameter, and identifying the selected closure device size as a recommended closure device. The method may further comprise simulating deployment of a closure device within the patient's LAA for a closure device having the recommended size. The method may further comprise simulating deployment of a closure device within the patient's LAA for a closure device having a size different from the recommended size. The method may further include generating a graphical representation of the deployed closure device within the patient's LAA, including superimposing a simulated deployed closure device having a recommended size on the graphical representation of the patient's LAA and superimposing simulated deployed closure devices having different sizes on the graphical representation of the patient's LAA. In some implementations, the method includes generating a plurality of images comprising a representation of the patient's LAA and a representation of an interface representing contact between the deployed closure device and the patient's LAA. In some implementations, the plurality of images includes a representation of the patient's LAA, a representation of the interface, and a representation of a leak path. The method may further include generating a rotatable model from the plurality of images. In some implementations, generating a graphical representation of the fixation of the closure device within the patient's LAA includes generating an image of the simulated deployed closure device including a representation of anchors of the closure device and a representation of engagement of the anchors with tissue of the patient's LAA. In some implementations, the representation of anchor engagement includes a color map.

[0008] In some embodiments, the present disclosure may be implemented as a computer-readable storage medium containing instructions that, when executed by a processor of a computing device, cause the processor to perform any of the methods described herein. In some embodiments, the present disclosure may be implemented as a computing system that includes a processor and a memory containing instructions that, when executed by the processor, cause the computing system to implement any of the methods described herein.

[0009] In some examples, the present disclosure may be implemented as a computing system including a processor and memory containing instructions that, when executed by the processor, cause the computing system to receive an image including a representation of the patient's LAA, receive a representation of a landing zone of a closure device, simulate deployment of the closure device in the patient's LAA, simulate sealing of the deployed closure device to the patient's LAA, simulate fixation of the closure device in the patient's LAA, and generate a graphical representation of the sealing and fixation of the closure device in the patient's LAA.

[0010] In some implementations, the computing system includes instructions that, when executed by the processor, cause the computing system to generate a graphical representation of a deployed closure device in the patient's LAA. In some implementations, the computing system includes instructions that, when executed by the processor, cause the computing system to generate a graphical representation of the deployed closure device in the patient's LAA, including overlaying the simulated deployed closure device with the graphical representation of the patient's LAA. In some implementations, the computing system includes instructions that, when executed by the processor, cause the computing system to determine a recommended size of the closure device based on the received image.

[0011] In some examples, the disclosure includes a computer-readable storage medium containing instructions that, when executed by a processor of a mechanical device, cause the processor to receive an image including a representation of the patient's LAA, receive a representation of a landing zone for a closure device, identify a diameter of an ostium of the patient's LAA based on the received image, select a closure device size from a set of closure device sizes that is within a threshold dilation diameter relative to the diameter of the ostium, identify the selected closure device size as a closure device, simulate deployment of the closure device in the patient's LAA, simulate fixation of the closure device in the patient's LAA, and generate a graphical representation of the sealing and fixation of the closure device in the patient's LAA.

[0012] In some embodiments, a computer-readable storage medium includes instructions that, when executed by a processor, cause a computing system to simulate deployment of a closure device within a patient's LAA for a closure device having a recommended size. In some embodiments, a computer-readable storage medium includes instructions that, when executed by a processor, cause a computing system to simulate deployment of a closure device within a patient's LAA for a closure device having a size different from the recommended size. [Brief explanation of the drawings]

[0013] To easily identify the discussion of any element and action, the most significant digit(s) in a reference number refers to the figure number in which that element is first introduced. FIG. 1 illustrates an LAA closure planning system in accordance with an embodiment of the present disclosure.

[0014] FIG. 2 illustrates a logic flow in an embodiment of the present disclosure. FIG. 3A illustrates an image of the LAA in an embodiment of the present disclosure. FIG. 3B illustrates an image of the LAA in an embodiment of the present disclosure.

[0015] 4A and 4B illustrate a simulated seal of a closure device in accordance with an embodiment of the present disclosure. 5A, 5B, 5C, and 5D illustrate leak paths in an embodiment of the present disclosure.

[0016] 6A, 6B, and 6C illustrate a simulated seal of a closure device in accordance with an embodiment of the present disclosure. FIG. 7 illustrates a leak path in an embodiment of the present disclosure.

[0017] FIG. 8 illustrates a leak path graph in an embodiment of the present disclosure. 9A and 9B illustrate a simulated locking engagement in accordance with an embodiment of the present disclosure.

[0018] FIG. 10 illustrates an example of a computer-readable storage medium in accordance with an embodiment of the present disclosure. FIG. 11 illustrates an example of a computing device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] The foregoing has outlined broadly the technical advantages of the present disclosure in order that the following detailed description of the disclosure may be better understood. It should be appreciated by those skilled in the art that the disclosed embodiments may readily be utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. The novel features of the present disclosure, both as to its organization and method of operation, together with further objects and advantages, will be better understood from the following description when considered in connection with the accompanying drawings. It is to be expressly understood, however, that each of the drawings is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

[0020] FIG. 1 illustrates an LAA closure planning system 100 in a non-limiting example of the present disclosure. Generally, the LAA closure planning system 100 is a system for planning LAA closure using a closure device. For example, the Watchman FLX® by Boston Scientific Corporation® is an LAA closure device. Patients with non-valvular atrial fibrillation may be treated for LAA closure by implanting a closure device within the LAA to, for example, reduce the risk of thromboembolism from the LAA. The present disclosure may be used to pre-plan a procedure for closure of the LAA with such a device.

[0021] The LAA closure planning system 100 includes a computing device 102. Optionally, the LAA closure planning system 100 includes an imaging device 104 and a display device 106. By way of example, the computing device 102 may receive an image or set of images representative of a patient's anatomy. For example, the computing device 102 may receive an LAA image 118 from the imaging device 104. In some embodiments, the imaging device 104 may be a CT imaging device equipped to generate an image including a representation (or representation) of the patient's LAA. From a portion of the LAA image 118, the computing device 102 may generate a simulated LAA closure image 132 including a representation of a simulated closure device deployment within the patient's LAA (e.g., the LAA depicted in the LAA image 118).

[0022] Although this disclosure uses CT imaging to describe exemplary embodiments, the imaging device 104 may be any LAA imaging device, such as, for example, a fluoroscopic imaging device, an ultrasound imaging device, a computed tomography (CT) imaging device, a magnetic resonance (MR) imaging device, a positron emission tomography (PET) imaging device, or a single photon emission computed tomography (SPECT) imaging device.

[0023] The imaging device 104 may generate information elements or data, including a representation of the LAA image 118. The computing device 102 may be communicatively coupled to the imaging device 104 to receive data from the imaging device 104, including a representation of the LAA image 118. Generally, the LAA image 118 may include a representation of shape and / or appearance data of the LAA. The shape data may include landmarks, surfaces, and boundaries of the three-dimensional surface of the LAA. In some examples, the LAA image 118 may be constructed from two-dimensional (2D) or three-dimensional (3D) images of the LAA. In some embodiments, the LAA image 118 may be a medical image stored in a medical image database and may be subject to access controls for medical images. The term "image" is used herein for clarity of presentation and to suggest that the LAA image 118 represents the structure and anatomy of the LAA. However, it will be understood that the term "image" is not limiting. That is, the LAA image 118 may not be a conventional image, but rather an image that is visible and understandable by a human. For example, the LAA image 118 may be a point cloud, a parametric model, or a morphological description of the anatomy of the LAA. Additionally, the LAA image 118 may be a single image or a series of images.

[0024] Generally, the display device 106 may be a digital display adapted to receive rendered image data and display the data in a graphical user interface. The computing device 102 may be any of a variety of computing devices. In some embodiments, the computing device 102 may be incorporated into and / or implemented by the console of the display device 106. In some embodiments, the computing device 102 may be a workstation or server communicatively coupled to the imaging device 104 and / or the display device 106. In still other embodiments, the computing device 102 may be provided by a cloud-based computing system, such as a computing as a service system available over a network (e.g., the Internet, an intranet, a wide area network, etc.). The computing device 102 may include a processor 108, a memory 110, input and / or output (I / O) devices 112, and a network interface 114.

[0025] Processor 108 may include circuitry or processor logic, such as any of a variety of commercially available processors. In some examples, processor 108 may include multiple processors, multithreaded processors, multi-core processors (whether multiple cores coexist on the same die or on separate dies), and / or other types of multi-processor architectures in which multiple physically separate processors are linked in some way. Additionally, in some examples, processor 108 may include a graphics processing portion, as well as dedicated memory, multi-threaded processing, and / or other parallel processing capabilities. In some examples, processor 108 may be an application specific integrated circuit (ASIC) or a field programmable integrated circuit (FPGA).

[0026] Memory 110 may include logic, a portion of which may include an array of integrated circuits forming non-volatile memory or a combination of non-volatile and volatile memory for persistent storage of data. It will be appreciated that memory 110 may be based on any of a variety of technologies. In particular, the array of integrated circuits included in memory 120 may be arranged to form one or more memories, such as dynamic random access memory (DRAM), NAND memory, NOR memory, etc.

[0027] I / O device 112 may be any of a variety of devices for receiving input and / or output. For example, I / O device 112 may include a keyboard, a mouse, a joystick, a foot pedal, a display different from display device 106 (e.g., touch, non-touch, etc.), a tactile feedback device, an LED, etc.

[0028] Network interface 114 may include logic and / or features to support a communications interface. For example, network interface 114 may include one or more interfaces operating according to various communications protocols or standards for communicating over direct or network communications links. Direct communications may occur through the use of communications protocols or standards set forth in one or more industry standards (including their descendants and variations). For example, network interface 114 may facilitate communications over buses such as peripheral component interconnect express (PCIe), non-volatile memory express (NVMe), universal serial bus (USB), system management bus (SMBus), SAS (e.g., serial attached small computer system interface (SCSI)) interfaces, serial AT attachment (SATA) interfaces, etc. Additionally, network interface 114 may include logic and / or features to enable communications over various wired or wireless network standards (e.g., 802.11 communications standards). For example, network interface 114 may be configured to support wired communications protocols or standards such as Ethernet. As another example, the network interface 114 may be configured to support wireless communication protocols or standards such as Wi-Fi, Bluetooth, ZigBee, LTE, 5G, etc.

[0029] The memory 110 may include instructions 116, an LAA image 118, a landing zone 120, a closure device model 122, an LAA model 124, a deployment simulation 126, a seal simulation 128, a fixation simulation 130, and a simulated LAA closure image 132. During operation, the processor 108 may execute the instructions 116 to cause the computing device 102 to receive the LAA image 118 from the imaging device 104 and the landing zone 120 from a physician via the input and / or output (I / O) device 112. The processor 108 may further execute the instructions 116 to identify a recommended closure device size and simulate the deployment, seal, and fixation of the recommended closure device. Additionally, the processor 108 may execute the instructions 116 to generate a simulated LAA closure image 132 and display 132 on the display device 106.

[0030] In general, the closure device model 122 and the LAA model 124 may be finite elements and may be used with any of a variety of finite element methods (FEM), such as the applied element method (AEM), augmented finite element method (A-FEM), generalized FEM, mixed FEM, variable polynomial, hpk-FEM, extended FEM (XFEM), scaled boundary FEM (SBFEM), smoothed FEM (SFEM), meshfree methods, discontinuous Galerkin methods, stretched grid methods, finite element limit analysis, Loubignac iteration, crystal plasticity finite element method (CPFEM), virtual element method (VEM), etc.

[0031] In other examples, the closure device model 122 and the LAA model 124 may be machine learning models, particularly models adapted for image recognition and processing, such as neural networks, convolutional neural networks, k-nearest neighbors, decision trees, support vector machines, etc.

[0032] In some examples, the processor 108 may execute the instructions 116 to solve equations represented by the closure device model 122 and the LAA model 124, taking into account the LAA image 118 and the landing zone 120 (e.g., if the closure device model 122 and the LAA model 124 are finite elements), to determine the deployment simulation 126, the sealing simulation 128, and the anchoring simulation 130. In other examples, the processor 108 may execute the instructions 116 to generate outputs from the closure device model 122 and the LAA model 124, taking into account the LAA image 118 and the landing zone 120 (e.g., if the closure device model 122 and the LAA model 124 are machine learning models), to infer the deployment simulation 126, the sealing simulation 128, and the anchoring simulation 130. In some examples, although not shown, one or more closure device models 122 and / or LAA models 124 may be provided for each “simulation” (e.g., the deployment simulation 126, the sealing simulation 128, or the anchoring simulation 130).

[0033] The processor 108 may execute the instructions 116 to generate (e.g., process, render, etc.) a simulated LAA closure image 132 from the deployment simulation 126, the seal simulation 128, and / or the fixation simulation 130.

[0034] The above is described in more detail below, for example, in conjunction with 200 from FIG. 2. In some examples, the LAA closure planning system 100 may be provided with only the computing device 102. That is, the LAA closure planning system 100 may include the computing device 102, and a user of the LAA closure planning system 100 may provide the imaging device 104 and the display device 106, with the imaging device 104 and the display device 106 compatible with the computing device 102. In other examples, the LAA closure planning system 100 may include only the instructions 116, the closure device model 122, and the LAA model 124, and may be executed by an equivalent computing system (e.g., a cloud computing service, etc.) to generate the simulated LAA closure image 132, as outlined herein.

[0035] It should be noted that LAA closure planning system 100 includes custom components that are specifically configured, programmed, and / or installed to execute the logic flows and methods detailed herein. For example, processor 108 may be pre-configured to perform FEM using finite elements, such as closure device model 122 and LAA model 124. As another example, processor 108 may be pre-configured to infer output from machine learning models (e.g., closure device model 122 and LAA model 124).

[0036] Furthermore, the closure device model 122 and the LAA model 124 are specifically pre-programmed with the detailed logic flows, methods and techniques described herein and are not conventional or general-purpose computing components.

[0037] 2 illustrates a logic flow 200 in some embodiments of the present disclosure. Logic flow 200 may be implemented to generate pre-procedure planning images for an LAA closure procedure based on pre-procedure imaging. For example, logic flow 200 may be provided to generate simulated LAA closure images 132 taking into account LAA image 118. While logic flow 200 is described with reference to LAA closure planning system 100 and FIG. 1, examples are not limited thereto and logic flow 200 may be implemented by a system including the components depicted in FIG. 1.

[0038] Logic flow 200 may reside in block 202. At block 202, "Receive an image including a representation of the anatomy of the patient's LAA," an image including a representation of the anatomy of the patient's LAA is received. For example, LAA image 118 may be received by computing device 102 from imaging device 104. Processor 108 may execute instructions 116 to receive LAA image 118 from imaging device 104.

[0039] Proceeding to block 204, "Receive Indication of Landing Zone of Closure Device in LAA," a landing zone within the patient's LAA is received. For example, landing zone 120 may be received by computing device 102 (e.g., from a physician via input and / or output (I / O) device 112). As a specific example, processor 108 may execute instructions 116 to display LAA image 118 on display device 106, and landing zone 120 may be received from the physician, for example, via touchscreen gestures, via mouse input, or other similar methods.

[0040] Proceeding to block 206, "Determine recommended closure device size based on image and desired landing zone," a recommended closure device size is determined based on the image and landing zone. In some examples, various closure devices, e.g., closure devices having sizes ranging from 20 to 40 millimeters (mm), may be available and may be represented by closure device model 122. In some examples, processor 108 may execute instructions 116 to identify a size based on the ostial diameter of the LAA represented in LAA image 118 at landing zone 120. In some embodiments, in block 206, processor 108 may execute instructions 116 to determine a recommended size or initial starting size for the simulation, and the final recommended size may be based on the simulations described herein (e.g., the simulations at blocks 212, 214, etc.).

[0041] In some instances, a recommended closure device is identified based on determining the maximum LAA diameter at the landing zone and selecting a closure device that has a diameter like the maximum LAA diameter at the landing zone when compressed 10 to 30%.

[0042] Proceeding to block 208, "Simulate Closure Device Deployment," deployment of the determined closure device size (and optionally one or more sizes) within the patient's LAA is simulated. For example, deployment simulation 126 is generated based on LAA image 118, landing zone 120, closure device model 122, and LAA model 124. More specifically, processor 108 may execute instructions 116 to generate deployment simulation 126 from LAA image 118, landing zone 120, closure device model 122, and LAA model 124. As a specific example, processor 108 may execute instructions 116 to solve equations represented by finite elements of closure device model 122 and LAA model 124 to simulate how the determined closure device size responds (e.g., stretches and deploys) to the anatomy of the LAA represented in LAA image 118, taking into account landing zone 120. Additionally, in some embodiments, processor 108 may execute instructions 116 to solve equations represented by finite elements of closure device model 122 and LAA model 124 to simulate how alternative closure device sizes (e.g., larger and smaller closure device sizes or all closure device sizes, etc.) respond (e.g., stretch and deploy, etc.) to the LAA anatomy represented in LAA image 118, taking into account landing zone 120. In some embodiments, processor 108 may execute instructions 116 to generate a surface mesh of the LAA (e.g., a stereolithography (STL) mesh, etc.) from LAA image 118, which is then converted to an FEA mesh.

[0043] Proceeding to block 210, "Simulate Seal of Closure Device," a seal of the determined closure device size within the patient's LAA is simulated. For example, seal simulation 128 is generated based on LAA image 118, landing zone 120, closure device model 122, LAA model 124, and deployment simulation 126. More specifically, processor 108 may execute instructions 116 to generate seal simulation 128 from LAA image 118, landing zone 120, closure device model 122, LAA model 124, and / or deployment simulation 126. As a specific example, processor 108 may execute instructions 116 to solve equations represented by finite elements of closure device model 122 and LAA model 124 to simulate how an expanded and deployed closure device (e.g., a closure device having the determined size and optionally alternative sizes) seals (or forms a seal) against the LAA anatomy represented in LAA image 118, taking into account landing zone 120 and deployment simulation 126.

[0044] Proceeding to block 212 "Simulate Fixation of Closure Device," fixation of the determined closure device size within the patient's LAA is simulated. For example, fixation simulation 130 is generated based on LAA image 118, landing zone 120, closure device model 122, LAA model 124, and deployment simulation 126. More specifically, processor 108 may execute instructions 116 to generate fixation simulation 130 from LAA image 118, landing zone 120, closure device model 122, LAA model 124, and / or deployment simulation 126. As a specific example, processor 108 may execute instructions 116 to solve equations represented by finite elements of closure device model 122 and LAA model 124 to simulate how an expanded and deployed closure device (e.g., a closure device having the determined size and optionally alternative sizes) will fixate within the LAA anatomy represented in LAA image 118, taking into account landing zone 120 and deployment simulation 126.

[0045] Proceeding to block 214, "Generate several images including representations of deployment, sealing, and fixation," several images including representations of deployment, sealing, and fixation are generated. For example, a simulated LAA closure image 132 is generated from the LAA image 118, the landing zone 120, the deployment simulation 126, the seal simulation 128, and / or the fixation simulation 130. The processor 108 may execute the instructions 116 to generate the simulated LAA closure image 132 from the LAA image 118, the landing zone 120, the deployment simulation 126, the seal simulation 128, and / or the fixation simulation 130. In some examples, the processor 108 may execute the instructions 116 to generate 132 based on overlaying the LAA depicted in the LAA image 118 with the simulated deployed closure device, the simulated seal, and / or the simulated fixation. As described above, in some embodiments, multiple simulations (e.g., a recommended closure device size and an alternative closure device size) are simulated. Thus, the simulated LAA closure image 132 may include multiple images representing different simulations for different closure device sizes.

[0046] 3A and 3B show LAA images 300a and 300b, respectively. LAA images 300a and 300b are representative views of LAA images and may be similar to LAA image 118 described above. For example, LAA images 300a and 300b may be CT images of the patient's LAA and may be received by computing device 102 from imaging device 104, as outlined above. As noted above, in some embodiments, LAA image 118 may be a series of images (e.g., multiple views, angles, etc.) of the patient's LAA. The LAA anatomy and model from LAA model 124 may be determined based on multiple LAA images 118. For example, points within the images representing a particular LAA anatomy may be identified, and a model from LAA model 124 having similar points (e.g., the same, within a threshold distance, etc.) may be selected for use.

[0047] 4A and 4B show simulated deployment image 400a and simulated deployment image 400b, respectively. Simulated deployment image 400a and simulated deployment image 400b represent images of deployment of a closure device within the LAA and may be similar to the image of simulated LAA closure image 132 described above. For example, simulated deployment image 400a includes LAA 402, which is a graphical representation of the patient's LAA (e.g., based on LAA image 118), and a graphical representation of a recommended sized deployed closure device 404a. Similarly, simulated deployment image 400a includes LAA 402 and a graphical representation of an alternative sized deployed closure image 404b.

[0048] 5A, 5B, 5C, and 5D show simulated seal images 500a, 500b, 500c, and 500d, respectively. Simulated seal images 500a, 500b, 500c, and 500d represent the seal or contact of a closure device with the anatomy of the LAA. For example, simulated seal images 500a, 500b, 500c, and 500d include the LAA 402 and a graphical representation of the seal or contact of a closure device (of a recommended size or alternative size) with respect to the periphery of the LAA. In some examples, this may be shown from several perspectives (e.g., four in this case). These images include a contact surface 502 that indicates (e.g., depicts) the seal of the closure device with the LAA and a leak path 504 that indicates (e.g., depicts) a gap in the contact between the closure device and the LAA 402.

[0049] In some examples, the simulated seal images 500a, 500b, 500c, 500d may be provided as part of the simulated LAA closure image 132. In other examples, the simulated seal images 500a, 500b, 500c, 500d may be represented as a 3D model and may be manipulated (e.g., rotated, etc.) to show all angles of the LAA 402, including the contact surface 502 and any leak paths 504. As another example, the simulated LAA closure image 132 may include a video that includes frames of images such as the simulated seal images 500a, 500b, 500c, 500d to provide a graphical representation of the periphery of the LAA 402, showing the contact surface 502 and leak paths 504.

[0050] In some examples, a simulated closure image can be generated based on a two-dimensional (2D) cross-sectional map of the desired landing zone with the deployed closure device, where the contours of the LAA anatomy and closure device are identified or suggested, while any "gaps" between the LAA anatomy and the closure device can be highlighted (e.g., suggested by color, graphics, etc.).

[0051] FIG. 6A shows a simulated fixation engagement image 600. The simulated fixation engagement image 600 includes a representation of a deployed closure device of a recommended size (or an alternative size). It will be appreciated that LAA closure devices often include anchors for engaging the LAA tissue, which "hold" the closure device in place until the LAA tissue grows into or around the closure device. For example, the simulated fixation engagement image 600 shows the deployed closure device 404a with anchors 602. Additionally, the simulated fixation engagement image 600 includes a graphical representation of the engagement (or indication) of the tips of each anchor 602. For example, the simulated fixation engagement image 600 includes a color map indicating the penetration distance of each anchor 602 into the tissue of the LAA 402. In another example, the simulated fixation engagement image 600 may include a color map indicating the contact force of each anchor 602 against the tissue of the LAA 402.

[0052] 6B shows in more detail an exploded view 604 from the simulated fixation engagement image 600 of FIG. 6A. As can be clearly seen in this figure, the fixation engagement 606 for each anchor 602 of the deployed closure device 404a is depicted as a color map (or heat map) that indicates (or represents) the engagement (e.g., penetration depth, contact force, etc.) of the anchor 602 with the tissue of the LAA 402.

[0053] In some examples, the simulated seal images 500a, 500b, 500c, 500d may be provided as part of the simulated LAA closure image 132. In other examples, the simulated seal images 500a, 500b, 500c, 500d may be represented as a 3D model and may be manipulated (e.g., rotated, etc.) to show all angles of the LAA 402, including the contact surface 502 and any leak paths 504. As another example, the simulated LAA closure image 132 may include a video that includes frames of images such as the simulated seal images 500a, 500b, 500c, 500d to provide a graphical representation of the periphery of the LAA 402, showing the contact surface 502 and leak paths 504.

[0054] In some embodiments, the processor 108 may execute instructions 116 to determine a suitable size for the LAA closure device based on various simulated seal images. FIGS. 6A, 6B, and 6C each illustrate a pair of seal images 600a, 600b, and 600c, respectively. These seal image pairs depict the simulated seal of the LAA closure devices 602a, 602b, and 602c against the LAA anatomy 604. From these image pairs or from the FAE simulation and image data, the processor 108 may execute instructions 116 to determine a path loop (e.g., around the LAA closure device 602a) having a minimum gap area. This minimum gap area and / or minimum gap path may be reported to a user (e.g., via the display device 106, etc.). In some embodiments, the processor 108 may execute instructions 116 to use the simulated seal to determine a minimum gap area based on hydraulic diameter or flow resistance.

[0055] For example, Figure 7 shows LAA anatomy 702 and leak path 704 based on a simulated deployed closure device (not shown). Figure 8 shows a graph 800 showing leak path 704 gap plotted on 804 against distance along the leak path 704 on the x-axis 802. In some examples, the total leak path 704 gap may be integrated (e.g., area under graph 800, etc.), and the closure device with the smallest total leak path gap may be identified as the preferred or recommended closure device size. In some embodiments, the integrated leak path gap may be normalized to the closure device size (e.g., 35 mm, 37 mm, 40 mm, etc.).

[0056] FIG. 9A shows a simulated fixation engagement image 900. The simulated fixation engagement image 900 includes a representation of a deployed closure device of a recommended size (or an alternative size). It will be appreciated that LAA closure devices often include anchors for engaging the LAA tissue, which "hold" the closure device in place until the LAA tissue grows into and around the closure device. For example, the simulated fixation engagement image 900 shows the deployed closure device 404a with anchors 902. Additionally, the simulated fixation engagement image 900 includes a graphical representation of the engagement (or indication) of the tips of each anchor 902. For example, the simulated fixation engagement image 900 includes a color map indicating the penetration distance of each anchor 902 into the tissue of the LAA 402. In another example, the simulated fixation engagement image 900 may include a color map indicating the contact force of each anchor 902 against the tissue of the LAA 402.

[0057] 9B shows an exploded view 904 from the simulated fixation engagement image 900 of FIG. 9A in more detail. As can be clearly seen in this figure, the fixation engagement 906 for each anchor 902 of the deployed closure device 404a is shown as a color map (or heat map) that indicates (or represents) the engagement (e.g., penetration depth, contact force, etc.) of the anchors 902 with the tissue of the LAA 402. In some embodiments, penetration depth may be identified and reported (e.g., to mark areas of potential pre-formation, etc.). In other examples, the number of engaged anchors (e.g., above a threshold level, etc.) may be identified and reported (e.g., to indicate potential stability of deployment, etc.).

[0058] FIG. 10 illustrates a computer-readable storage medium 1000. The computer-readable storage medium 1000 may include any non-transitory computer-readable or machine-readable storage medium, such as an optical storage medium, a magnetic storage medium, or a semiconductor storage medium. In various embodiments, the computer-readable storage medium 1000 may include an article of manufacture. In some embodiments, the computer-readable storage medium 700 may store computer-executable instructions 1002 that may be executed by a circuit (e.g., processor 108, etc.). For example, the computer-executable instructions 1002 may include instructions for implementing the operations described for logic flow 200, instructions 116, closure device model 122, and / or LAA model 124. Examples of the computer-readable storage medium 1000 or machine-readable storage medium may include any tangible medium capable of storing electronic data, such as volatile memory, non-volatile memory, removable or non-removable memory, erasable or non-erasable memory, writable or rewritable memory, etc. Examples of computer-executable instructions 1002 may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, object-oriented code, visual code, etc.

[0059] 11 diagrammatically represents a machine 1100 in the form of a computer system within which a set of instructions may be executed to cause the machine 1100 to perform any one or more of the methodologies described herein. More specifically, FIG. 11 diagrammatically represents a machine 1100 in the form of an exemplary computer system within which instructions 1108 (e.g., software, a program, an application, an applet, an app, or other executable code) may be executed to cause the machine 1100 to perform any one or more of the methodologies described herein. For example, the instructions 1108 may cause the machine 1100 to perform logic flow 200 of FIG. 2 , or the like. More generally, the instructions 1108 may cause the machine 1100 to provide a pre-procedure plan for an LAA closure procedure, such as receiving LAA images 118 and generating a deployment simulation 126, a seal simulation 128, a fixation simulation 130, and / or a simulated LAA closure image 132, as described above.

[0060] The instructions 1108 transform the generic, unprogrammed machine 1100 into a specific, specifically programmed machine 1100 configured to perform the functions described and illustrated in a particular manner. In alternative embodiments, the machine 1100 operates as a standalone device or may be coupled (e.g., networked) with other machines. In a networked deployment, the machine 1100 may operate as a server machine or a client machine in a server-client network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. The machine 1100 may comprise, but is not limited to, a server computer, a client computer, a personal computer (PC), a tablet computer, a laptop computer, a netbook, a set-top box (STB), a PDA, an entertainment media system, a mobile phone, a smartphone, a handheld device, a wearable device (e.g., a smart watch), a smart home device (e.g., a smart appliance), other smart devices, a web appliance, a network router, a network switch, a network bridge, or any machine capable of serially or otherwise executing instructions 1108 that define actions to be taken by the machine 1100. Additionally, while only a single machine 1100 is illustrated, the term "machine" should also be construed to include a collection of machines 200 that individually or collectively execute instructions 1108 to perform any one or more of the methods described herein.

[0061] Machine 1100 may include processor 1102, memory 1104, and I / O components 1142, which may be configured to communicate with each other, for example, via bus 1144. In one example embodiment, processor 1102 (e.g., a central processing unit (CPU), a reduced instruction set computer (RISC) processor, a complex instruction set computer (CISC), a graphics processing unit (GPU), a digital signal processor (DSP), an ASIC, a radio frequency integrated circuit (RFIC), or other processor, or any suitable combination thereof) may include processor 1106 and processor 1110, which may execute instructions 1108. The term "processor" is intended to include multi-core processors, which may include two or more independent processors (sometimes referred to as "cores") that may simultaneously execute instructions. While multiple processors 1102 are shown in FIG. 11, machine 1100 may include a single processor with a single core, a single processor with multiple cores (e.g., a multi-core processor), multiple processors with a single core, multiple processors with multiple cores, or any combination thereof.

[0062] Memory 1104 may include a main memory 1112, a static memory 1114, and a storage unit 1116, all of which are accessible to processor 1102, for example, via bus 1144. Main memory 1104, static memory 1114, and storage unit 1116 store instructions 1108 that embody any one or more of the methods described herein. The instructions 1108 may reside, completely or partially, within main memory 1112, within static memory 1114, within a machine-readable medium 1118 in storage unit 1116, within at least one of processors 1102 (e.g., within a processor's cache memory), or any suitable combination thereof, during their execution by machine 1100.

[0063] I / O components 1142 may include a wide variety of components for receiving input, providing output, generating output, transmitting information, exchanging information, obtaining measurements, etc. The specific I / O components 1142 included in a particular machine will depend on the type of machine. For example, a portable machine such as a mobile phone may include a touch input device or other input mechanism, while a headless server machine, for example, may not include such a touch input device. It will be understood that I / O components 1142 may include many other components not shown in FIG. 11 . I / O components 1142 are grouped according to function solely to simplify the following description, and this grouping is in no way limiting. In various example embodiments, I / O components 1142 may include output components 1128 and input components 1130. Output components 1128 may include visual components (e.g., a plasma display panel (PDP), a light-emitting diode (LED) display, a liquid crystal display (LCD), a projector, a cathode ray tube (CRT)), acoustic components (e.g., speakers), tactile components (e.g., vibration motors, resistive mechanisms), other signal generators, etc. Input components 1130 may include alphanumeric input components (e.g., a keyboard, a touchscreen configured to receive alphanumeric input, an optical keyboard, or other alphanumeric input component), point-based input components (e.g., a mouse, touchpad, trackball, joystick, motion sensor, or other pointing device), tactile input components (e.g., physical buttons, a touchscreen that provides the location and / or force of a touch or touch gesture, or other tactile input component), audio input components (e.g., a microphone), etc.

[0064] In further example embodiments, I / O component 1142 may include a biometric component 1132, a motion component 1134, an environmental component 1136, a position component 1138, among a wide variety of other components. For example, biometric component 1132 may include components for detecting expressions (e.g., hand expressions, facial expressions, vocal expressions, body gestures, gaze tracking), measuring biometric signals (e.g., blood pressure, heart rate, body temperature, sweat, or brain waves), identifying people (e.g., voice identification, retinal identification, facial identification, fingerprint identification, electroencephalogram-based identification), etc. Motion component 1134 may include an acceleration sensor component (e.g., an accelerometer), a gravity sensor component, a rotation sensor component (e.g., a gyroscope), etc. The environmental components 1136 may include, for example, an illuminance sensor component (e.g., a photometer), a temperature sensor component (e.g., one or more thermometers that detect ambient temperature), a humidity sensor component, a pressure sensor component (e.g., a barometer), an acoustic sensor component (e.g., one or more microphones that detect background noise), a proximity sensor component (e.g., an infrared sensor that detects nearby objects), a gas sensor (e.g., a gas detection sensor for detecting concentrations of toxic gases for safety purposes or for measuring pollutants in the air), or other components that may provide an indication, measurement, or signal corresponding to the surrounding physical environment. The position component 1138 may include a location sensor component (e.g., a GPS receiver component), an altitude sensor component (e.g., an altimeter or barometer that detects air pressure from which altitude can be calculated), an orientation sensor component (e.g., a magnetometer), etc.

[0065] Communications may be implemented using a wide variety of technologies. I / O component 1142 may include a communications component 1140 operable to connect machine 1100 to network 1120 or device 1122 via coupling 1124 and coupling 1126. For example, communications component 1140 may include a network interface component or other suitable device for interfacing with network 1120. In further examples, communications component 1140 may include a wired communications component, a wireless communications component, a cellular communications component, a near field communications (NFC) component, a Bluetooth® component (e.g., Bluetooth® Low Energy), a Wi-Fi® component, or other communications component for providing communications via other modalities. Device 1122 may be another machine or any of a wide variety of devices (e.g., a peripheral device connected via USB).

[0066] Further, the communications component 1140 may detect an identifier or may include a component operable to detect an identifier. For example, the communications component 1140 may include a radio frequency identification (RFID) tag reader component, an NFC smart tag detection component, an optical reader component (e.g., an optical sensor for detecting one-dimensional barcodes such as Universal Product Code (UPC) barcodes, multidimensional barcodes such as Quick Response (QR) Code, Aztec Code, Data Matrix, Dataglyph, MaxiCode, PDF147, UltraCode, UCC RSS-2D barcodes, and other optical codes), or an acoustic detection component (e.g., a microphone for identifying tagged audio signals). Additionally, various information may be calculated via the communications component 1140, such as location information calculated via Internet Protocol (IP) geolocation, location information calculated via Wi-Fi® communication triangulation, and location information calculated via detection of NFC beacon signals that may indicate a particular location.

[0067] Various memories (i.e., memory 1104, main memory 1112, static memory 1114, and / or memory of processor 1102) and / or storage units 1116 may store one or more sets of instructions and data structures (e.g., software) that embody or are utilized by any one or more of the methods or functions described herein. These instructions (e.g., instructions 1108), when executed by processor 1102, cause various operations to be performed to implement the disclosed embodiments.

[0068] As used herein, the terms “mechanical storage medium,” “device storage medium,” and “computer storage medium” mean the same thing and may be used interchangeably in this disclosure. These terms refer to a single or multiple storage devices and / or media (e.g., centralized or distributed databases and / or associated caches and servers) that store executable instructions and / or data. These terms are intended to include, but are not limited to, solid-state memory, optical, and magnetic media, including memory internal or external to a processor. Specific examples of mechanical storage media, computer storage media, and / or device storage media include non-volatile memory, such as semiconductor memory devices, e.g., erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), FPGAs, and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The terms "mechanical storage media," "computer storage media," and "device storage media" specifically exclude carrier waves, modulated data signals, and other media, at least some of which are covered by the term "signal media" described below.

[0069] In various example embodiments, one or more portions of network 1120 may be an ad-hoc network, an intranet, an extranet, a VPN, a LAN, a WLAN, a WAN, a WWAN, a MAN, the Internet, a portion of the Internet, a portion of the PSTN, a plain old telephone service (POTS) network, a cellular telephone network, a wireless network, a Wi-Fi network, other types of networks, or a combination of two or more such networks. For example, network 1120 or portions of network 1120 may include a wireless or cellular network, and coupling 1124 may include a code division multiple access (CDMA) connection, a Global System for Mobile communications (GSM) connection, or other type of cellular or wireless coupling.In this example, coupling 1124 may implement any of various types of transport technologies, such as Single Carrier Radio Transmission Technology (1xRTT), Evolution-Data Optimized (EVDO) technology, General Packet Radio Service (GPRS) technology, Enhanced Data rates for GSM Evolution (EDGE) technology, third Generation Partnership Project (3GPP) including 3G, fourth generation wireless (4G) networks, Universal Mobile Telecommunications System (UMTS), High Speed ​​Packet Access (HSPA), Worldwide Interoperability for Microwave Access (WiMAX), Long Term Evolution (LTE) standards, others defined by various standards setting bodies, other long-range communication protocols, or other data transport technologies.

[0070] The instructions 1108 may be transmitted or received over the network 1120 using a transmission medium via a network interface device (e.g., a network interface component included in communications component 1140) and utilizing any one of several well-known transmission protocols (e.g., Hypertext Transfer Protocol (HTTP)). Similarly, the instructions 1108 may be transmitted or received to the device 1122 via coupling 1126 (e.g., a peer-to-peer coupling) using a transmission medium. The terms “transmission medium” and “reception medium” mean the same thing and may be used interchangeably in this disclosure. The terms “transmission medium” and “reception medium” are intended to include any intangible medium that may store, encode, or carry instructions 1108 for execution by the machine 1100, including digital or analog communications signals or other intangible media for facilitating communication of such software. Accordingly, the terms “transmission medium” and “reception medium” are intended to include any form of modulated data signal, carrier wave, etc. A “modulated data signal” means a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal.

[0071] Terms used in this specification should be given their ordinary meaning in the relevant art or the meaning suggested by their use in context, except that if an express definition is provided, that meaning will control.

[0072] References herein to "one embodiment" or "an embodiment" do not necessarily refer to the same embodiment, but may. Throughout this specification and claims, terms such as "comprises," "comprising," and the like are not intended to be exclusive or exhaustive, but rather to be construed in an inclusive sense, i.e., "including, but not limited to," unless the context clearly requires a different interpretation. Terms using the singular or plural also include the plural or singular, respectively, unless expressly limited to the singular or plural. In addition, the terms "herein," "above," "below," and terms of similar import, when used herein, refer to this application as a whole, not to any portion thereof. When a claim uses the term "or" in connection with a list of two or more items, the term covers all interpretations of that term, in other words, any of the items in the list, all of the items in the list, or any combination of the items in the list, unless expressly limited to only one. Any terms not expressly defined herein have their conventional meanings as commonly understood by those of ordinary skill in the art.

Claims

1. 1. A method for pre-planning left atrial appendage (LAA) closure, comprising: receiving an image including a representation of the patient's LAA; receiving an indication of a landing zone of the closure device; simulating deployment of the closure device within the patient's LAA; simulating sealing of the deployed closure device against the patient's LAA; and simulating fixation of the closure device within the patient's LAA; generating a graphical representation of the seal and the fixation of the closure device within the patient's LAA. A method for pre-planning left atrial appendage (LAA) closure.

2. The method of claim 1 , comprising generating a graphical representation of the deployed closure device within the patient's LAA.

3. 3. The method of claim 2, wherein generating a graphical representation of the deployed closure device in the patient's LAA includes overlaying the simulated deployed closure device on a graphical representation of the patient's LAA.

4. The method of any one of claims 1 to 3, comprising determining a recommended size of the closure device based on the received images.

5. identifying an ostial diameter of the patient's LAA based on the received image; selecting a closure device size from a set of closure device sizes that is within a threshold expanded diameter relative to the diameter of the stoma; and identifying the selected closure device size as the recommended closure device.

6. The method of claim 4 , comprising, for a closure device having the recommended size, simulating deployment of the closure device within the patient's LAA.

7. The method of claim 6, comprising simulating deployment of a closure device within the patient's LAA for a closure device having a size different from the recommended size.

8. 7. The method of claim 6, comprising generating a graphical representation of the deployed closure device within the patient's LAA, including superimposing the simulated deployed closure device having the recommended size on the graphical representation of the patient's LAA, and superimposing the simulated deployed closure device having a different size on the graphical representation of the patient's LAA.

9. 9. The method of claim 1, wherein generating the graphical representation of the seal of the deployed closure device within the patient's LAA comprises generating a plurality of images including a representation of the patient's LAA and a representation of a contact surface representative of contact between the deployed closure device and the patient's LAA.

10. The method of claim 9 , wherein the plurality of images includes a representation of the patient's LAA, a representation of the contact surface, and a representation of a leak path.

11. The method of claim 10 , comprising generating a rotatable model from the plurality of images.

12. 12. The method of any one of claims 1 to 11, wherein generating the graphical representation of the fixation of the closure device within the patient's LAA comprises generating an image of the simulated deployed closure device including a representation of anchors of the closure device and a depiction of engagement of the anchors with tissue of the patient's LAA.

13. The method of claim 12 , wherein the depiction of the engagement of the anchors comprises a color map.

14. 10. A computer-readable storage medium containing instructions that, when executed by a processor of a computing device, cause the processor to perform the method of claim 1.

15. 1. A computing system comprising: a processor; a memory containing instructions; The instructions, when executed by the processor, cause the computing system to perform the method of claim 1. Computing system.

Images