Simulations for planning a minimally invasive procedure

Abstract

Medical interventions utilizing catheters require precise and carefully controlled movement of a catheter and deployment of a medical device to limit damage (e.g., to the heart, veins, etc.). Pre-procedure simulation of catheter control can improve patient safety and outcomes. Information about a patient's anatomy, the catheter, and a medical device (e.g., an implant) can be used to create a patient specific anatomical model and a device model. The device model can be simulated moving through at least a portion of the anatomical model towards a deployment location to determine a desired implant deployment pose and develop at least one path for the device model to take towards the implant deployment location to reach the implant deployment pose minimizing contact-based damage to the anatomical model. The implant deployment pose and / or the path to reach the implant deployment location can be output to at least a display for viewing.

Description

A0013395W001MDT-033926 WO ORDNONPROVISIONAL APPLICATIONSIMULATIONS FOR PLANNING A MINIMALLY INVASIVE PROCEDURERelated Applications

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 705,632, filed October 10, 2024, entitled “PROSTHETIC VALVE DELIVERY PROCEDURE PLANNING USING PHYSICS BASED SIMULATION” and U.S. Provisional Application Serial No. 63 / 814,202, filed May 29, 2025, entitled “SIMULATIONS FOR PLANNING A MINIMALLY INVASIVE PROCEDURE.” The entirety of these provisional applications is hereby incorporated by reference for all purposes.Technical Field

[0002] The present disclosure relates to simulations for planning a minimally invasive procedure, and more specifically, to systems and methods for multi-modal simulations for planning device movements and avoiding and / or reducing damaging interactions.Background

[0003] Minimally invasive procedures remedy the serious risks inherent to traditional invasive surgical techniques. For example, minimally invasive valve replacement and / or stent placement procedures have reduced the need for invasive procedures such as sternotomy and cardiopulmonary bypass. Catheters are now commonly used to deliver a variety of medical devices to target locations. The medical devices can be compressed within the catheter for transport and then expanded at the target location once the target location is reached. Such devices can include prosthetic valves, stents, stent grafts, and the like. However, minimally invasive surgical procedures have their own set of challenges. Vasculature and organs, such as the heart, can be damaged when contacted by the catheter and / or device. Surgeons rely on complicated combinations of pre-procedure medicalA0013395W001MDT-033926 WO ORD images that provide a static and generally more detailed picture of the anatomy and in-procedure active imaging that helps the surgeon determine where a catheter is within the anatomy at a given time. However, patient anatomy is not static (e.g., over a cardiac cycle) and can be more complicated to maneuver through than anticipated based on the pre-procedure medical images. Catheter maneuvering and implant deployment can be further complicated by a complex relationship between catheter control inputs, catheter body movements, and catheter end point movements that can make it difficult to plan and reach target locations.Summary

[0004] Simulation can be used to plan a minimally invasive procedures, such as heart valve replacements and / or repairs or stent placements, ensuring patient safety. The systems and methods described herein utilize physics-based four-dimensional modeling to predict and prevent harmful interactions between an inserted device (e.g., a catheter, an implant, etc.) and the patient’s anatomy. Many portions of the heart and the vasculature are extremely delicate, complex, and can change shape over the course of the cardiac cycle and / or the respiratory cycle and are thus difficult to model with current technologies.

[0005] A system is described that can determine a path to reach a predetermined implant deployment location at a desired implant pose while minimizing potential damage to a patient. The system can include a display configured to display a graphical output and a controller in communication with the display. The controller can include a non-transitory memory configured to store instructions and a processor configured to execute the following instructions. Receive parameters including anatomical information, catheter information, and implant information. The anatomical information can include at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle, the catheter information can include at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter, and the implant information can include at least dimensionality of at least a portion of the implant. The instructions further include create an anatomical model of at least the portion of the heart and a device model. The anatomical model can include at least an ostium into the heart, at least a portion of an interior surface of the heart,A0013395W001MDT-033926 WO ORD and a predetermined deployment location of the implant, based on at least a portion of the anatomical information. The device model can be created based on the catheter information and the implant information and can include at least an exterior shape of the catheter, at least one kinematic joint of the catheter, and at least a top plane of the implant. The system can then simulate the device model moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model. The simulation can determine a desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location, and develop at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with without contacting a surface of the anatomical model, wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion. The desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose can be output (e.g., to the display, the memory, a controller of the catheter, or the like).

[0006] A method is described for determining a path to reach a predetermined implant deployment location at a desired implant pose while minimizing potential damage to a patient. The system comprising at least a processor can receive parameters that can include anatomical information, catheter information, and implant information. The anatomical information can include at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle. The catheter information can include at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter. The implant information can include at least dimensionality of at least a portion of the implant. An anatomical model of at least the portion of the heart can be created that can include at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant. The anatomical model of the at least the portion of the heart can be based on at least a portion of the anatomical information. A device model can be created based on the catheter information and the implant information. The device model can include at least an exterior shape of the catheter, at least one kinematic joint of the catheter,A0013395W001MDT-033926 WO ORD and at least a reference point of the implant. The device model can be simulated moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model. The simulation can determine a desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location. The simulation can also develop at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with a surface of the anatomical model, wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion. The desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose can be output (e.g., to a display, a memory, a controller of the catheter, or the like).Brief Description of the Drawings

[0007] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which:

[0007] FIG. 1 is a diagram representation of a system for simulating movements of a device within an anatomical model during a minimally invasive procedure while avoiding and / or reducing damaging interactions;

[0008] FIG. 2 is an example of a controller of the system of FIG. 1 ;

[0009] FIG. 3 is an example of model creation on the controller of FIG. 2;

[0010] FIG. 4 is an example of developing a simulation on the controller of FIG.2;

[0011] FIG. 5 is an example GUI of a simulation using the system of FIG. 1 ;

[0012] FIG. 6 is a representation of calibration for the system of FIG. 1 ;

[0013] FIG. 7 is representation of anatomical database progressions for the system of FIG. 1 ;

[0014] FIG. 8 is a representation of a control roadmap for the system of FIG. 1 ;A0013395W001MDT-033926 WO ORD

[0015] FIG. 9 is a representation of a kinematics calibration for the system of FIG. 1 ;

[0016] FIGS. 10,11 , and 12 are process flow diagrams of methods for simulating movements of a device within an anatomical model during a minimally invasive procedure and avoiding and / or reducing damaging interactions; and

[0017] FIG. 13 is a process flow diagram of methods for training a user of a catheter with the anatomical and device models.Detailed DescriptionI. Definitions

[0018] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0019] As used herein, the singular forms “a,” “an,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0020] As used herein, the terms “comprises” and / or “comprising,” can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups.

[0021] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0022] As used herein, the terms “first,” “second,” etc. should not limit the elements being described by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or acts / steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0023] It will be understood that when an element is referred to as being "on," "attached" to, "connected" to, "coupled" with, "contacting," etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on," "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, thereA0013395W001MDT-033926 WO ORD are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0024] As used herein, the term “minimally invasive” when used with “procedure” refers to a procedure (e.g., surgical, diagnostic, or the like) that involves making small incisions in a patient’s body. Goals of a minimally invasive procedure can include, but are not limited to, minimizing trauma, pain, minimizing recovery time, minimizing complications, and the like. In some instances, an imaging device can be used to guide the minimally invasive procedure.

[0025] As used herein, the term “simulation” (or the verb simulate) refers to using a model to mimic how a system will react under certain conditions.

[0026] As used herein, the term “model” refers to an informational representation (e.g., a physical, mathematical, conceptual, or the like) representation one or more structures, a system of structures, operation of the system of structures, or the like.

[0027] As used herein, the term “medical device” refers to an article, instrument, apparatus, machine, or the like, used for detecting, measuring, restoring, correcting, or modifying a structure or function on and / or within a patient’s body for a health purpose. As an example, the medical device can be used in a minimally invasive procedure and may be an implantable device, a capsule used for deploying the implantable device, a deployment device used to navigate the implantable device, the capsule to an appropriate location within the body, or the like.

[0028] As used herein, the term “implantable device”, also referred to as an implant”, refers to a medical device intended to be housed on / within a patient’s body (for a period, either a temporary period or an extended / permanent period). The implantable device can be manufactured to replace a missing biological structure, support a damaged biological structure, enhance an existing biological structure, or the like. Examples of implantable device include, but are not limited to, a pacemaker, a defibrillator, a left ventricular assist device (LVAD), a renal denervation device, a sensor, a prosthetic heart valve, a stent, a stent graft, or the like.

[0029] As used herein, the term “catheter” refers to tubular medical device for insertion into canals, vessels, passageways, or bodily cavities. In some instances, the catheter can be flexible. As an example, the catheter can be inserted through a narrow opening to aid in a minimally invasive procedure.A0013395W001MDT-033926 WO ORD

[0030] As used herein, the term “anatomical” refers to something that relates to a structure of the body, such as information, a model, etc.

[0031] As used herein, the term “pose” refers to a position and orientation of a given object or part of an objected, such as a catheter and / or implantable medical device, in three dimensions. A pose includes a translation component and / or a rotation component.

[0032] As used herein, the term “path” refers to a series of points in space that an object can follow to move in space. As used herein, a path can be a series of points within a lumen of an anatomical model that a catheter can follow to reach a target location. In some instances, a path can be defined by the catheter positions required to reach each point because the catheter can have limited articulations and poses. The path can be constrained with boundary conditions that can cause the path to change, so the catheter does not violate any boundary conditions.

[0033] As used herein, the term “deployment location” refers to an intended position for an implant to be positioned, fixed, and / or embedded within at least a portion of the patient’s anatomy.

[0034] As used herein, the terms "subject" and "patient" can be used interchangeably and refer to any warm-blooded organism including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc.

[0035] As used herein, the term "medical professional" can refer to an individual who provides care to a patient. A medical professional can be, for example, a doctor, a physician' s assistant, a student, a nurse, a caregiver, or the like.II. Overview

[0036] Minimally invasive procedures have reduced the need for traditional invasive surgical techniques, remedying the serious risks inherent to traditional invasive surgical techniques. Minimally invasive valve replacement and / or stent placement procedures, for example, have reduced the need for invasive procedures such as sternotomy and cardiopulmonary bypass. Catheters are now commonly used to deliver a variety of medical devices to target locations in these minimally invasive procedures. The medical devices can be compressed within the catheter for transport and then expanded at the target location once the target location is reached. Such devices can include prosthetic valves, stents, stent grafts, and theA0013395W001MDT-033926 WO ORD like. However, minimally invasive surgical procedures have their own set of challenges. Delicate portions of the patient’s body (e.g., vasculature, organs, such as the heart, and the like) can be injured when contacted by the catheter and / or device (e.g., depending on force, angles, sharpness, type of tissue, condition of the tissue, etc.). Currently, surgeons rely on complicated combinations of pre-procedure medical images and in-procedure active imaging to determine a catheter’s position within the anatomy at a given time during a non-invasive medical procedure. However, patient anatomy is not static (e.g., over a cardiac cycle) and can be more complicated to maneuver through than anticipated based on the pre-procedure medical images. Catheter maneuvering and implant deployment can be further complicated by the complex relationships between catheter controls, catheter body movements, and catheter end-point movements required to move the catheter to access difficult to reach target locations. Different techniques have been used for intra-operative guidance to limit some of these complications, including image processing for intra-operative guidance and identification and tracking of anatomic landmarks and registration of data to a patient.

[0037] The systems and methods described here aim to improve intraoperative guidance by fusing multi-modal inputs, population based statistical analysis, life-like device physics parameters, and anticipated procedural delivery parameters, thereby generating improved models and improved guidance predictions. The improved guidance predictions can be used to guide a catheter and implant through a patient’s anatomy. In addition to generating guidance predictions, the systems and methods can suggest suitable next movement(s) of the delivery system controls to arrive at a predetermined deployment location, identify one or more configurations of the delivery system controls that may result in undesirable contact with patient anatomy, and / or the like. Using physics-based analysis to simulate delivery and deployment of a prosthetic valve enables a user to predict interaction between the delivery system and the patient anatomy. The physics-based simulation predicts behavior of the delivery system based on movement or adjustment of the controls of the delivery system while accounting for interaction within the patient anatomy, thereby improving the accuracy of both pre-procedural planning and intra-operative delivery. Using physics-based analysis to simulate delivery and deployment of a prosthetic valve enables a user to predict interaction between the delivery system and the patient anatomy. The physics-based simulationA0013395W001MDT-033926 WO ORD predicts behavior of the delivery system based on movement or adjustment of the control knobs of the delivery system while accounting for interaction within the patient anatomy, thereby improving the accuracy of both pre-procedural planning and intra-operative delivery.III. System

[0038] Minimally invasive procedures, in which catheters are used to deliver a variety of medical devices to target locations, can reduce the risks inherent to traditional surgical techniques. For example, two (non-limiting) common procedures that can be accomplished via minimally invasive techniques include valve replacement and stent placement, thus reducing the need for invasive procedures such as sternotomy and cardiopulmonary bypass. In each of these procedures, implantable medical devices (also referred to as “implants”) can be compressed within a catheter for transport and then expanded at a target location once the target location is reached. Described herein is a system 100 that can form multi-modal simulations and use the multi-modal simulations to plan device movements and provide improved intraoperative guidance (reducing and / or avoiding damaging interactions and / or forces). Notably, the simulations can fuse multi-modal inputs and life-like physics parameters to generate improved models and improved guidance predictions. Unlike previous simulation techniques, that simulations of system 100 acknowledge and account for the fact that patient anatomy is not static (e.g., over a cardiac cycle) and acknowledge the complexities of catheter maneuvering and implant deployment. The improved guidance predictions of the system 100 can improve catheter design, the accuracy, safety, and efficacy of instructions for catheter use, and provide life-like practice for maneuvering of catheter delivery systems through at least a portion of a patient’s body.

[0039] FIG. 1 shows an example system 100 for creating and running simulations that fuse multi-modal inputs and physics to at least generate improved intraoperative guidance predictions and planning. System 100 can include a controller 102 that can create, perform, and / or alter simulations and / or various aspects of simulations. The controller 102 can be in communication (wired and / or wireless) with a display 112 (e.g., a visual display device, a monitor, etc.) such that the controller 102 can provide one or more outputs (e.g., a current path and extrapolated next path points, improved intraoperative guidance predictions andA0013395W001MDT-033926 WO ORD planning, or the like) to the display 112 and the display 112 can visualize one or more graphical representations of the one or more outputs, the simulated components, and / or the like.

[0040] The controller 102 can include a memory 104 (e.g., a non-transitory memory) that can store instructions, data, information, and the like, and a processor 106 that can access the memory 104 and execute the instructions, and in some instances, utilize the stored data, information, or the like. The memory 104 and processor 106 can be embodied as unique and separate devices within the controller 102 (as shown) or, in some instances, can be embodied as a single device (e.g., a microprocessor). The system 100 and any of the individual components of the system, such as the controller 102, can include wiring, wireless transceivers / transmitters / receivers, an internal power source, a connection means to an external power source, and / or the like (not shown for ease of illustration).

[0041] In some instances, the controller 102 can be in wired and / or wireless communication with a user interface 108 and / or one or more medical imaging devices 1 10 to receive input data and / or information relevant to the simulation to be created and performed. The controller 102 can also be in wired and / or wireless communication with at least the display 112 that can visualize a graphical representation of the simulation, suggested instructions, simulation variables, warnings, and / or the like. In other instances, the controller 102 can be in wired and / or wireless communication with a catheter 1 14 (or other surgical implement for performing a minimally invasive procedure, such as delivering an implant 116) to output information, such as path and / or deployment pose information, directions for use in a procedure, and / or the like.

[0042] In creating and performing the simulations, the controller 102 can receive information (e.g., anatomical information, catheter information, implant information, etc.) from the user interface 108 and / or the one or more medical imaging devices 110. Information can be entered into the user interface 108 by a user (e.g., technician, medical professional, or the like) and / or information can be sent from one or more medical imaging devices 110 (e.g., at the behest of the user). For instance, the user interface 108 can receive at least one input comprising at least one parameter, at least one path variable, the predetermined implant deployment location, and / or the like. The user interface 108 can be, for example, a keyboard, a mouse, a touch screen, a microphone, a connection to an electronic health recordA0013395W001MDT-033926 WO ORD(e.g., housed in one or more databases), a data input port (e.g., USB input, CD input, or the like), another device that can include another controller, or the like that can receive information and then send the information to the controller 102. In another instance the user interface 108 can be a real and / or a training version of a catheter control device (e.g., a handle, a gaming controller, a joystick, or the like for a steerable catheter). The one or more medical imaging devices 110 can include one or more sensors and / or imaging devices, such as, a computed tomography (CT) machine, an X-ray machine (e.g., for fluoroscopy), a magnetic resonance imaging (MRI) machine, a positron emission tomography (PET) scanner, an ultrasound, or the like. It should be understood that these examples are for illustrative purposes only and other types of medical devices and / or sensors can be understood to act as inputs to the controller 102. Furthermore, the memory 104 of the controller 102 can store the information and / or other data received as input from the user interface 108 and / or medical imaging device 110 so the information and / or other data need not be input for every use and so that, in some instances, the simulations and / or models can be built upon larger populations of data (e.g., for generalized instruction purposes, research and design purposes, or the like).

[0043] The controller 102 can output information and / or data to the display 112 to at least form the graphical representation. The display 112 can be, for instance, a liquid crystal display, an OLED display, a 3D display, a holographic display, a headsup display, or the like. The graphical representation can include, for instance, at least a portion of the catheter model, the implant model, the anatomical model, and / or the like. The graphical representation may be a graphical user interface and can include variable interface elements (e.g., sliders, data entry points, clickable action items, or the like) that can be controlled via use of user input (e.g., from the user interface 108) to initiate changes in the performance of the controller 102 and / or the simulation.

[0044] In some instances, the controller 102 can output information to a control device of a catheter 1 14 to preload suggested maneuvering steps (e.g., directions) for and / or for instructions to physically move (automatically control) the catheter (and the implant 116) on at least one path based on the simulations to avoid and / or reduce damaging (or potentially damaging) interactions between a device (e.g., the catheter 114, the implant 116, or the like) and at least a portion of a patient’s anatomy. The catheter 114 can correspond to the catheter of the device model (e.g.,A0013395W001MDT-033926 WO ORD can be a same model and / or can have a same size, a same number of degrees of freedom, or the like, as the catheter of the device model) and the implant 116 can correspond to the implant of the device model (described in detail below). The implant 116 can be removably attached to and / or at least partially inside a lumen of the catheter 114 (e.g., deployable from the catheter) according to the known steps of a given procedure.

[0045] FIG. 2 shows an example 200 of the controller 102 that can form a simulation and perform the simulation of a minimally invasive procedure that can avoid and / or reduce interactions between the device (e.g., the catheter, the implant, or the like) and at least the portion of the patient’s anatomy. For illustrative purpose, a heart valve replacement procedure (e.g., for a tricuspid valve, a mitral valve, an aortic valve, or the like) is described but should not be construed to be limiting. Examples of other procedures that can be simulated with this system (and the method described below) can include, but are not limited to, placement of a pacemaker (e.g., Medtronic’s MICRA™), a coronary stent, or the like, for procedures such as a renal denervation, catheter mediated ablations, biopsy, and / or internal imaging, or the like, and / or the like. The processor 106 can execute the instructions stored on the memory 104 (e.g., the non-transitory memory) utilizing stored and / or input information. The processor 106 can execute instructions to receive (or retrieve) parameters 202. The parameters can include anatomical information 204, catheter information 206, implant information 208, and the like. The anatomical information 204 can include, for instance, at least one image from a sequence of images of at least a portion of heart over at least one cardiac cycle. The catheter information 206 can include, for instance, at least external dimensional information (e.g., exterior length, width, circumference, etc.) of a catheter (e.g., catheter 1 14) and kinematic joint information representing articulations, bend angles, degrees of freedom of the catheter, and / or control inputs for the catheter (e.g., handle controls). The implant information 208 can include, for instance, at least dimensionality (e.g., at least one reference point, a top plane, an encapsulated circumference, a diameter, a length, a height, a width or the like) of at least a portion of the implant (e.g., prosthetic valve, stent, graft, pacemaker, LVAD, a renal denervation device, a sensor, or the like) or another medical device that may not be implanted, such as a biopsy needle, ablation device, imaging device, or the like.A0013395W001MDT-033926 WO ORD

[0046] The processor 106 can execute instructions to create models 210, including but not limited to anatomical model 212 and device model 214. The anatomical model 212 can be created based at least in part on at least a portion of the anatomical information 202. As an example, the anatomical model 212 can be, for instance, at least a portion of the heart received as anatomical information 204. For example, the portion of the heart can include at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant within and / or adjacent to the heart. The device model 214 can be created based on the catheter information 206 and the implant information 208. The device model 214 can include, for instance, least an exterior shape of at least a portion of the catheter (e.g., the portion of the catheter inserted into the relevant anatomy), at least one kinematic joint of the catheter, and at least one reference point and / or at least a top plane of the implant.

[0047] The processor 106 can simulate a procedure 216 where the device model 214 can move through at least a portion of anatomical model 212 towards the predetermined implant deployment location of the anatomical model. The simulation can, for instance, develop at least one path 218 and / or determine at least one deployment pose 220 of the catheter and / or the implant. Through the simulation the processor 106 can determine a desired implant deployment pose 220 and / or a trajectory for releasing the implant from the catheter. The desired implant deployment pose can include including a position and orientation of at least the top plane and / or the at least one reference point of the implant at the predetermined implant deployment location. The processor 106 can also develop at least one path 218 for the device model 214 via the simulation. The at least one path can be a path the device model 214 to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging and / or potentially damaging contact with a surface of the anatomical model 212. The at least one path can include at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion. In some instance, the at least one path can be embodied as catheter controls (e.g., knobs or buttons to push, joystick directions, etc.). In other instances, the at least one path can be embodied within a joint space, configuration space, and / or task space. Additionally, the predetermined implant deployment location and / or the desired implant deployment pose can include compensation for known deploymentA0013395W001MDT-033926 WO ORD dynamics of a given implant. Such as, but not limited to, the phenomena of foreshortening where the implant changes length in the deployment sequence. By including this dynamic, an optimal deployment position of the desired implant deployment pose can be better captured, and simulations can better represent final implant outcomes.

[0048] The processor 106 can then output the at least one path and / or the desired (implant and / or catheter) deployment pose 222 to the display (e.g., display 112, control device of the catheter 114, etc.), the memory 102, another device comprising a memory and / or a processor, or the like. In some instances, the output can be the desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose. In other instances, the output can include instructions to physically move the catheter and the implant on the at least one path. The processor 106 can also and / or alternatively output instructions to physically move the catheter and the implant on the at least one path to the control device of the catheter (e.g., catheter 114). The catheter (e.g., catheter 114) can correspond to the catheter of the device model (e.g., can be a same model and / or can have a same number of degrees of freedom as the catheter of the device model) and the implant (e.g., implant 116) can correspond to the implant of the device model. The implant (e.g., implant 116) can be removably attached to and / or at least partially inside the catheter (e.g., catheter 114) (e.g., deployable). The controller 102 via processor 106 can, in some instances, automatically steer the catheter (e.g., catheter 114) with the implant attached along the at least one path to the predetermined implant deployment location, wherein the implant is deployed in the implant deployment pose at the predetermined implant deployment location.

[0049] FIG. 3 shows a more detailed example 300 of model creation (e.g., instruction 210). As previously noted, the anatomical model 212 can be based on anatomical information that can be at least one image from a sequence of (anatomical) images 302 of at least a portion of a heart over at least one cardiac cycle. The sequence of images 302 over the at least one cardiac cycle can include, for instance, a plurality of three-dimensional (3D) computed tomography images of the at least the portion (e.g., surface, section, etc.) of the heart corresponding to a plurality of time points during the at least one cardiac cycle. The anatomical model 212 of the at least the portion of the heart can move in time with the at least oneA0013395W001MDT-033926 WO ORD cardiac cycle (e.g., simulate the at least one cardiac cycle). The anatomical model 212 can be based on manual and / or Al assisted segmentation of the sequence of images 302 and can include surfaces and / or volumes as 3D surface geometry (e.g., STL file) and landmarks as curves, planes, points, or the like. Material properties for tissues and / or foreign objects (e.g., stents, etc.) of the portion of the heart can also be included in the anatomical model 212 for improved simulations (e.g., stent material may stretch more or less than tissue, tissue thickness can effect allowable collision forces, etc.).

[0050] As noted, the anatomical model 212 can include at least an ostium 304 into the heart, at least a portion of an interior 306 (e.g., interior surface) of the heart, and a predetermined deployment location 308 of the implant within and / or adjacent to the heart. In one instance, when planning and simulating a tricuspid valve replacement, the ostium 304 into the heart is an ostium of an inferior vena cava (IVC), the at least the portion of the interior 306 of the heart is at least a portion of the right side of the heart, and the implant deployment location 308 is an annulus of a tricuspid valve. For example, the ostium of the IVC can be modeled as a minimum ostium in a plane as an initial boundary condition and the annulus of the tricuspid valve can be modeled as a spline. In another instance, when planning and simulating a mitral valve replacement, the ostium 304 into the heart can be an ostium of a fossa ovalis, the at least the portion of the interior 306 of the heart can be at least a portion of the left side of the heart, and the implant deployment location 308 can be an annulus of the mitral valve. The device model 214 can include a catheter model 310 and an implant model 312 created based on catheter information and implant information. The catheter information can include at least one dimension 318 (e.g., external dimensional information such exterior length, width, circumference, etc.) of a catheter (e.g., catheter 114), one or more reference points 314 of the catheter (e.g., end points, bend points, etc.) and / or information on at least one kinematic joint 316 of the catheter representing articulations, bend angles, and / or degrees of freedom of the catheter. For example, the catheter information can include at least one of: at least one two-dimensional (2D) fluoroscopy image of the catheter, synthetic and / or simulated echo and / or ultrasound views, one or more mathematically determined shapes, positions, and / or articulation points of the catheter, one or more three- dimensional (3D) scans of the catheter, or a finite element analysis model of the catheter.A0013395W001MDT-033926 WO ORD

[0051] The implant information 208 can include at least one dimension 318 and / or at least one referent point 314 of the implant (e.g., at least one reference point, a top plane, an encapsulated circumference, a diameter, a length, a height, a width or the like) of at least a portion of the implant (e.g., prosthetic valve, stent, graft, pacemaker, LVAD, a renal denervation device, a sensor, or the like) or another medical instrument that may not be implanted (e.g., a biopsy needle, an ablation device, an imaging device, or the like). For example, the implant information can include at least one of: at least one two-dimensional (2D) fluoroscopy image of at least a portion of the implant, synthetic and / or simulated echo and / or ultrasound views, a mathematical determination of an aspect of the implant pose, one or more reference points on the implant, a 3D scan of the implant, a finite element analysis model of the implant, and / or the like. The device model 214 can include, as noted above, least an exterior shape of at least a portion of the catheter (e.g., the portion of the catheter inserted into the relevant anatomy), at least one kinematic joint of the catheter, and at least one reference point, at least a top plane of the implant, and / or the like.

[0052] FIG. 4 shows an example 400 of how a simulation can develop at least one path 218, in FIG. 4, element A, and determine a deployment pose 220, FIG. 4, element B. The controller (e.g., controller 102) can be given the conditions to maneuver through the portion of the heart to the final position (e.g., the predetermined deployment location). As an example, the conditions can be based on one or more goals, such as have no collisions with the anatomical model, have minimal or reduced collisions, and / or have collisions of a soft enough force to not cause damage that would significantly affect patient’s health. FIG. 4, element A, shows a device model moving through a traditionally challenging portion of a patient’s heart (e.g., a portion that can require multiple bends of the catheter to reach the predetermined implant deployment location). The simulation can be specifically configured with a centerline and boundary conditions to focus on collision avoidance and to account for the articulations (e.g., kinematic joint number and flexibility) of the catheter model. Collision avoidance can include avoiding the device model (catheter and / or un-deployed implant) contacting (or contacting with a damaging force, determined based on the materials and specific tissues) a portion of the ostium into the heart, any portion of the interior surface of the heart, the implant deployment location, and / or the like.A0013395WG01MDT-033926 WO ORD

[0053] For instance, the instruction to simulate the device model moving through the at least the portion of the anatomical model (e.g., 216) towards the predetermined implant deployment location in the anatomical model can be based at least in part on a collision aware algorithm and / or an artificial intelligence reinforcement algorithm to avoid collisions, reduce collisions, and / or reduce collision force, or the like. For example, the collision aware algorithm can calculate finite element analysis physics between at least a portion of the device model and the at least the portion of the anatomical model that can be applied to avoid collisions, reduce collisions and / or collision force, or the like. As another example, an artificial intelligence reinforcement algorithm can be used to perform reduced order methods to estimate physics parameters of at least a portion of the device model and the at least the portion of the anatomical model to avoid collisions, reduce collisions and / or collision force, or the like. The collision aware algorithm(s) can include an internal “solver” that can iterate (e.g., in a data loop) instructions for best collision avoidance (and / or other desired results). For instance, the solver can be in the form of one or more loops that include updating system state (e.g., using control inputs / variables, from user or system), calculating catheter pose based on kinematics and physics, assessing for collisions between at least the device model and the anatomical model, rendering collision interaction effects, and calculating metrics of implant and catheter pose (which can be visualized on the display and / or logged in memory as events for learning purposes (e.g., for the algorithm, user, or the like)).

[0054] FIG. 4, element B shows an example of the components used to determine a desired implant deployment pose 220. First, the controller (e.g., controller 102 of FIG. 1 ) can determine a trajectory of the implant, and, optionally, at least the portion of the catheter connected to the implant (not shown), to best position and orient the implant to deploy at the predetermined deployment location (e.g., a tricuspid valve, mitral valve, etc.) for optimal (or near optimal) surgical attachment. For example, the approach angle relative the valve can be optimized for best results. The implant deployment pose (position and orientation) can be further refined (e.g., with translation and / or rotations by and / or from the end of the catheter) when the implant is near and / or at the predetermined implant deployment location. For instance, the controller (e.g., controller 102 of FIG. 1 ) can determine if and / or when the implant is coaxial and centered with the valve. The depth of the deployment can then be determined for optimal implantation based on the procedureA0013395W001MDT-033926 WO ORD and / or the specific patient anatomy (e.g., not too deep, and not too shallow). Additionally and / or alternatively, the predetermined implant deployment location and / or the desired implant deployment pose can include compensation for known deployment dynamics of a given implant. Such as, but not limited to, the phenomena of foreshortening where the implant changes length in the deployment sequence. By including this dynamic, an optimal deployment position of the desired implant deployment pose can be better captured, and simulations can better represent final implant outcomes In some instances, an artificial intelligence reinforcement algorithm can perform reduced order methods to estimate at least some of the physics parameters to determine the optimal deployment depths, poses, trajectories, or the like.

[0055] FIG. 5 shows an example graphical user interface (GUI) 500 of a simulation using the system 100 of FIG. 1 that can be embodied on a display 112 and can be controlled via a user interface 108 connected to controller 102 to simulate and plan a tricuspid valve replacement. A tricuspid valve replacement can be used, for instance, when the tricuspid valve is regurgitating, which can compromise the cardiac output, to restore the cardiac output. Generally, a catheter sheath can be maneuvered up the inferior vena cava, the dilator can be removed, and then a steerable catheter delivery system can be introduced and steered into the tricuspid anulus and a capsule, including the replacement valve can be deployed forward to place the implant into the tricuspid valve, thereby replacing the valve. The steerable catheter delivery system can then be removed, and the cardiac function can be restored. However, steerable catheter delivery systems are complex, including a number of pieces, which make it a challenge to predict how catheter controls can influence deployment pose and end effector positions. One example catheter can include: the implant, the cradle which holds the delivery system, the distal end of the catheter which contains the delivery capsule, a movable shaft that the capsule is connected to, the sheath, and two nested catheters that can flex and bend (the inner catheter and the outer catheter), the catheter handle which allows for the flexing of the outer catheter and the rotation and the flexing of the inner catheter and the rotation and the articulation of the capsule forward and backwards. This example can give up to eleven degrees of freedom for articulation to move the device.A0013395W001MDT-033926 WO ORD

[0056] The example GUI 500 can show the simulation of the device model moving through at least a portion of the anatomical model (e.g., the right atrium) towards a predetermined implant deployment location (e.g., the tricuspid valve) in the anatomical model and avoiding collisions and / or reducing collisions and / or collision force. In FIG. 5, the ring at the bottom of the right atrium represents the tricuspid annulus, the plane on the left upper side represents the IVC, the small plane at the end of the catheter (shown as a column) (outside the right atrium) represents a top edge of the implant. In this example the plane of the implant is intended to line up with the planes of the inferior vena cava and the plane above the annulus for “perfect” deployment. The right side of the GUI, as shown, can include the different articulations that the catheter can achieve. The left side of the GUI, as shown, can include metrics that can define the deployment pose and location. Combined the articulations and the metrics can be referred to as variables and can include an advancement depth into the anatomical model, an inner flexion angle, an inner rotation angle, an inner advancement amount, an outer flexion angle, an outer rotation angle, a sheath rotation, a sheath translation, a system advancement quantity, and a deployment status. Conditions can be set and / or generated with population data and / or artificial intelligence for when the variables (the articulations and the metrics) are within optimal ranges (determined based on the device and / or the patient specific anatomy). It should be understood that FIG. 5 is an example of a display comprising a GUI (and changeable via a user interface) for illustrative purposes and is not intended to be limiting. Different device models, anatomical models, variables, articulations, and the like for other procedures known in the art should be understood.

[0057] The device model can be maneuvered through the anatomical model using robotics like steering articulations considered at least relative to the distal tip of the catheter. The device model can be considered in terms of one or more kinematic joints in series - sliding joints and / or rotating joints. Each joint may have a different amount of articulation available. Between each joint there is a change in the coordinate system, and following the series leads to a final joint (the distal tip) that can be used to get an understanding of the final joint and its position. For instance, the inputs of all of the joint angles can go into a forward kinematics calculation which can then tell us the position and the rotation of the distal tip of the device model (e.g., may include the implant and / or capsule) based on all of the input joint angles.A0013395W001MDT-033926 WO ORDAlternatively, if the position and the rotation of the distal tip of the device model at a step in time is known, then inverse kinematics can be used to determine all the joint angles of the device model and understand the range of articulations that are able to achieve the position and the rations of the distal tip of the device model at the given step in time. In the simulations run by the system (e.g., 100), with the example shown in FIG. 5, both the position and / or rotation of the distal tip and the range of articulations required to reach that position and / or rotation can be compared with boundary conditions representing the anatomy to determine optimal paths for avoiding collision and / or reducing collisions and / or collision forces between the device model and the anatomy model. For each simulation run through the system (e.g., 100) the system can ask - does the catheter achieve desired configuration in the anatomy at each step through the anatomy? If the answer is no, then the joints, meshes, and / or articulation controls can be altered (manually and / or automatically) until the answer is yes. The system (e.g., 100) described herein can also be utilized for improving catheter design. For example, the system can determine and / or help determine catheter dimensions, number of catheter bends, number of catheter degrees of freedom, control inputs and outputs (manual and / or automatic), or the like for improved catheter design.

[0058] FIG. 6 shows a representation 600 of calibration for the system 100 of FIG. 1 for a specific patient anatomy. It should be understood that the calibration does not necessarily have to occur in this manner, and this is only one example for illustrative purpose. The controller 102 can match 602 an anatomical model (created as described above) to at least one bench fluoroscopy image of a patient’s anatomy. The controller can simulate 604 at least one fluoroscopy view in the model simulation. The catheter can be steered in 3D space and a simulated fluoroscopy view can be generated at different view angles. Such a simulation can make moving between simulation and real world cases easier for a physician, as fluoroscopy may be used during the procedure. The controller can then estimate 606 a catheter pose for a clinical case and during the calibration a user can look at the at least one fluoroscopy view from a particular case and infer the 3D catheter position. This procedure can be done for any number of catheters and / or anatomies to calibrate the system (e.g., system 100) for optimal use.

[0059] FIG. 7 is representation of an example anatomical database progressions for the system 100 of FIG. 1 . It should be understood that theA0013395W001MDT-033926 WO ORD anatomical database progressions do not necessarily have to occur in this manner and are only one example for illustrative purpose. The anatomical information for the controller (e.g., controller 102) can be at least one 4D CT data set 702, e.g., the sequence of images over the at least one cardiac cycle. The 4D CT data 702 set can include a plurality of three-dimensional (3D) CT images corresponding to a plurality of time points during the at least one cardiac cycle for at least one surface of the heart. From the 4D CT data set 702, the anatomy model 704 can be created. The anatomy model 704 can include, for example if the anatomy model is specific to a tricuspid valve replacement, the right heart 3D stereolithography (STL) 706, which can define the right heart surface as a series of triangles; the annulus spline 708, which can define the positioning and minimum opening size of the tricuspid valve; and the inferior vena cava plane 710 and / or an IVC / venous access path STL, which can define the IVC as an ostium and as the initial boundary condition. In another instance, not shown, for an anatomy model of a mitral valve replacement the model can include a left heart STL and a fossa ovalis spline in addition to an IVC plane and / or an IVC / venous access path STL. Put more generally, the anatomy model 704 can include a number of anatomy structures represented as STLs to model access path(s), target anatomy, and key points (e.g., IVC ostium, fossa ovalis, valve annulus, etc.) A plurality of anatomy models 704 can be used as part of a feasibility study 712. From the feasibility study a statistical shape model 714 can be formed that can generate up to an essentially infinite number of synthetic patients. Al assisted segmentation 716 can also be utilized for further improved modeling options of the statistical shape model (e.g., improved boundary condition modeling, better physics fusions, or the like). The Al assisted segmentation can, for instance, automatically analyze a CT scan (of the 4D CT scan data 702) and pull out the different 3D STL models, shapes of the heart, shapes of the IVC, shapes of the aorta, annulus splines representing the tricuspid valve, or the like to create infinite numbers of 4D beating heart models.

[0060] FIG. 8 is a representation of a control roadmap 800 for the system 100 of FIG. 1 . It should be understood that the control roadmap does not necessarily have to occur in this manner and is only an example for illustration. Basic control of the system 100 can utilize manual control 802 (e.g. using user interface 108) to either mimic catheter control and / or to set the sliders (e.g., shown in FIG. 5) for changing variables of the path and / or final position. More advanced control can utilize a finalA0013395W001MDT-033926 WO ORD position auto-solver 804 that can mathematically determine at least one final position and path (based on available catheter articulations) to reach the predetermined implant deployment location with the implant in a desired implant deployment pose and while avoiding collision and / or reducing collisions and / or collision forces between the device model and the anatomy model (e.g., based on known boundary conditions). The auto-solver 804 can utilize Jacobean matrices and forwards and inverse kinematics. A further iteration of system control can utilize an algorithmic motion plan 806 to plan out motions that are collision aware such that motions for an entire procedure can be planned. Finally, a fully realized version of the system can also utilize an Al reinforcement learning motion plan 808 that can learn from manual operation, auto-solver operation, and algorithmic operation (both successful and non-successful simulations) to more effectively and timely create plans.

[0061] FIG. 9 is a representation of a kinematics calibration 900 for the system 100 of FIG. 1 to get the simulated version to match the physical version of a model. It should be understood that the kinematics calibration does not necessarily have to occur in this manner. The system 100 can determine if various portions of the device model are where they are predicted to be and how to eliminate positioning error. A 1stprinciples model calibration 902 can be performed. For instance, simple robotics models (sliding and rotating joints) and models of flexion in various components. Then a fluoro calibration study 904 can be completed by taking 2D fluoroscopy images and comparing them to calibrate the different flex motions, particularly how the components may interact with each other when, for instance, steering while nested with each other. The fluoro calibration study 904 can model various interactions. Laser scanner calibration 906 can also be utilized to automate the comparison to include an entire 3D surface of a catheter with virtual geometry of the device to ensure a good 3D match. Finally, Finite Element Analysis (FEA) calibration 908 can be used to model different physics interactions, including but not limited to, internal stresses and deflections within the device model (which can cause deviations from idealized kinematics). FEA calibration 908 can also be utilized to model interactions with the anatomy and / or the implant and how components of the device, anatomy, and / or implant move during interactions with each other. FEA calibration 908 can also render complex collision physics (e.g., elastic vs inelastic collisions, deflections, what angles and / or forces do and do not cause damage to various anatomical tissues, etc.).A0013395W001MDT-033926 WO ORD

[0062] The system 100 of FIG. 1 described above can be used for a number of different purposes. For instance, the system 100 can be used for planning patient specific procedures steps, where a physician can run one or more simulations of a procedure before attempting the real procedure to get an understanding of all the different steps that will be needed and where the challenge areas may lie in doing the procedure. In another instance new and / or improved devices can be evaluated in a diverse range of anatomies as opposed to the handful of cases that could be 3D print and currently used for physical simulations. In a further instance the system can be used for training physicians, technicians, and / or therapy delivery specialists to get an understanding of the counterintuitive ways that a catheter moves and how the different controls and / or knobs of the cradle of the catheter translate to motions inside of the heart, without the high-stakes pressure of performing the procedure in real life.IV. Method

[0063] Another aspect of the present disclosure can include methods 1000,1100, 1200, and 1300 (FIGS. 10, 1 1 , 12, and 13). Methods 1000, 1 100, and 1200 can be for simulating movements of a device within an anatomical model during a minimally invasive procedure and avoiding and / or reducing damaging interactions that can be implemented with system 100 (shown in FIG. 1 and described in detailed examples in FIGS. 2-9). Method 1300 can be for training a user of a catheter with the simulations described above. As an example, the methods 1000,1100, 1200, and 1300 can be executed by controller 102 of system 100.

[0064] The methods 1000,1 100, 1200, and 1300 are illustrated as process flow diagrams with flowchart illustrations that can be implemented by one or more components of the system 100. For purposes of simplicity, the methods 1000,1100, 1200, and 1300 are shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps may occur in different orders and / or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the methods 1000,1 100, 1200, and 1300.

[0065] FIG. 10 shows method 1000 for creating and performing a physics-based simulation that can predict behavior of the delivery system based on movement or adjustment of the controls of the delivery system while accounting for interactionsA0013395W001MDT-033926 WO ORD within the patient anatomy, thereby improving the accuracy of both pre-procedural planning and intra-operative delivery. The method can be used to validate catheter designs and / or implant designs, train medical professionals and / or technicians, test patient specific procedures, determine suitability of a patient for the procedure (e.g., determine if the catheter can navigate in the patient’s anatomy) and / or automatically control steering of a physical catheter.

[0066] At 1002, parameters can be received (e.g., by the controller 102 including at least the processor 106). As an example, the parameters can be received from a non-transitory memory (e.g., memory 104), a user interface (e.g., user interface 108), and / or one or more medical devices and / or sensors (e.g., medical device 110). The parameters can include anatomical information, catheter information, and implant information. The anatomical information can include, for instance, at least one image from a sequence of images of at least a portion of heart over at least one cardiac cycle. The sequence of images over the at least one cardiac cycle can include a plurality of three-dimensional (3D) computed tomography images corresponding to a plurality of time points during the at least one cardiac cycle (e.g., across different cardiac phases) for at least one surface of the heart.

[0067] The catheter information can include at least external dimensional information (e.g., exterior length, width, circumference, etc.) of a catheter (e.g., catheter 114) and kinematic joint information representing articulations, bend angles, and / or degrees of freedom of the catheter. In some instances, the catheter information can include at least one: at least one two-dimensional (2D) fluoroscopy image of the catheter, synthetic and / or simulated echo and / or ultrasound views, one or more mathematically determined shapes, positions, and / or articulation points of the catheter, one or more three-dimensional (3D) scans of the catheter, or a finite element analysis (FEA) model of the catheter. The catheter information can further include an interior shape of the catheter, a volumetric representation of an interior shape of the catheter, and / or a at least partial 3D model (the 3D scanned model and / or the FEA model) of the catheter. Information on interior shape and / or volumetric representations of the interior shape of a catheter can be advantageous for generating synthetic x-ray views (digital reconstructed radiographs) for the use in field-like training simulations and / or for the reverse engineering of field use to determine the exact path used in a clinical case. It is also noted that FEA models can be utilized for calculating physics such as forces, displacements, strain, and stress,A0013395W001MDT-033926 WO ORD or used with reduced order methods (e.g., machine learning neural networks or the like) to estimate more realistic physics parameters. Additionally, synthetic and / or simulated echo and / or ultrasound views can be useful in providing a realistic interface for physicians who often use echo for these minimally invasive procedures.

[0068] The implant information can include at least dimensionality (e.g., at least one reference point, a top plane, an encapsulated circumference, a diameter, a length, a height, a width or the like) of at least a portion of the implant (e.g., prosthetic valve, stent, graft, pacemaker, LVAD, a renal denervation device, a sensor, or the like) or another medical instrument that may not be implanted such as a biopsy needle, ablation device, imaging device, or the like. For instance, the implant information can include at least one two-dimensional (2D) fluoroscopy image of at least a portion of the implant, synthetic and / or simulated echo and / or ultrasound view, a mathematical determination of an aspect of the implant pose and / or one or more reference points on the implant, a 3D scan of the implant, or a finite element analysis model of the implant. It is similarly noted that FEA models can be utilized for calculating physics such as forces, displacements, strain, and stress, or used with reduced order methods (e.g., machine learning neural networks or the like) to estimate more realistic physics parameters. Additionally, synthetic and / or simulated echo and / or ultrasound views can be useful in providing a realistic interface for physicians who often use echo for these minimally invasive procedures.

[0069] At 1004 an anatomical model of at least a portion of the heart can be created based on at least a portion of the anatomical information. The anatomical model of the at least the portion of the heart can be static and / or can move in time with the at least one cardiac cycle (e.g., simulate the at least one cardiac cycle). The anatomical model can include at least an ostium into the heart, at least a portion of an interior (e.g., interior surface) of the heart, and a predetermined deployment location of the implant within and / or adjacent to the heart. In one instance, when planning and simulating a tricuspid valve replacement, the ostium into the heart is an ostium of an inferior vena cava (IVC), the at least the portion of the interior of the heart is at least a portion of the right side of the heart, and the implant deployment location is an annulus of a tricuspid valve. For example, the ostium of the IVC can be modeled as a minimum ostium in a plane as an initial boundary condition and the annulus of the tricuspid valve can be modeled as a spline. In another instance, when planning and simulating a mitral valve replacement, the ostium into the heart can beA0013395W001MDT-033926 WO ORD an ostium of a fossa ovalis, the at least the portion of the interior of the heart can be at least a portion of the left side of the heart, and the implant deployment location can be an annulus of the mitral valve.

[0070] At 1006, a device model can be created based on at least a portion of the catheter information and at least a portion of the implant information. The device model can include, for instance, least an exterior shape of at least a portion of the catheter (e.g., the portion of the catheter inserted into the relevant anatomy), at least one kinematic joint of the catheter, and at least one reference point and / or at least a top plane of the implant. In other instances, the device model can include interior shape and / or a volumetric representation of the catheter and / or the implant, which can be used for generating synthetic x-ray views (digital reconstructed radiographs) for the use in field-like training simulation and for the reverse engineering of field use to determine the exact path used in a clinical case. In some instance, the device model can be created with one or more statistical shape models, device specific scans, and / or Al assisted segmentation. The device model can include a catheter model and an implant model that can correspond with a real-world catheter and implant that a physician would use and can have the same number of degrees of freedom. The catheter may be in communication with the controller (e.g., controller 102).

[0071] At 1008, at least a portion of the device model can be simulated moving through at least a portion of the anatomical model towards a predetermined implant deployment location in the anatomical model. The simulation can be based at least on boundary conditions and a centerline intended to avoid collisions, reduce collisions, and / or reduce collision forces to decrease the likelihood of internal damage if the procedure was real. The simulation can be manually controlled (e.g. using user interface 108) to either mimic catheter control and / or to set sliders (e.g., shown in FIG. 5) for changing variables of the path and / or final position. More advance control can utilize a final position auto-solver that can mathematically determine at least one final position and path (based on available catheter articulations) to reach the predetermined implant deployment location with the implant in a desired implant deployment pose and while avoiding collision and / or reducing collisions and / or collision forces between the device model and the anatomy model (e.g., based on known boundary conditions). The auto-solver can utilize Jacobean matrices to relate changes in the position of the at least oneA0013395W001MDT-033926 WO ORD kinematic joint to changes in a current pose of the implant. A further iteration of control can utilize an algorithmic motion plan to plan out motions that are collision aware such that motions for an entire procedure can be planned. Finally, a fully realized simulation control can also utilize an Al reinforcement learning motion plan that can learn from manual operation, auto-solver operation, and algorithmic operation (both successful and non-successful simulations) to more effectively and timely create plans. The simulation can be, for instance, a simulation of a tricuspid valve replacement, as partially shown in FIG. 5. Further simulation details are discussed below in reference to method 1100 of FIG. 11 .

[0072] At 1010, a desired implant deployment pose (determined by the simulation) at the predetermined implant deployment location and the at least one path (developed by the simulation) to reach the predetermined implant deployment location with the implant in the desired implant deployment pose can be output. The output can be, for instance, to a memory, a display, and / or a control device of a real- world catheter. For example, the output can include instructions and / or suggested steps for physically moving the catheter and the implant along the at least one path (e.g., for a user to follow, for at least partially automatic control of the catheter, or the like). The output can further comprise a graphical representation of the anatomical model, the device model, and / or at least one path for the device model in the anatomical model where collisions with the at least the portion of the heart are avoided. Alternatively and / or additionally, the output at least one path can include a path selected to minimize interference with the anatomy using collision bounds to minimize and / or avoid injury. This can include collision reduction (based on Al, algorithms, etc.), and / or bounds within the models set to only allow forces and / or angles with reduced likelihood of injury and / or minimized interference with the anatomy.

[0073] FIG. 11 shows a further detailed method 1100 for performing the simulation to predict (and / or learn how to predict) behavior of the delivery system based on movement or adjustment of the controls of the delivery system while accounting for interactions within the patient anatomy. The simulation can be performed to avoid collisions, reduce collisions, and / or reduce at least collision forces to reduce and / or minimize internal damage to a patient.

[0074] At 1102, a desired implant deployment pose can be determined. The desired implant pose can include at least a position 1104 and an orientation 1106 ofA0013395W001MDT-033926 WO ORD at least a reference point and / or a top plane of the implant at the predetermined implant deployment location. The implant deployment pose can also be optimized for a specific procedure and / or anatomy. The desired implant deployment pose can include a trajectory of the implant, an angle of a reference point of the implant relative to the predetermined implant deployment location, a position of the implant, and / or a depth of the implant within at least the portion of the heart relative to the predetermined implant deployment location. For example, when aligning the implant to a valve annulus the alignment can be decomposed into position (referring to a projection of the implant landmark onto an annular plane of the annulus) and / or orientation as described here. However, it should be noted this is only one example and other methods or metrics describing alignment can be used. Deployment dynamics of the implant can also be predicted and a final implant pose can be described relative to the annulus in terms of, for example, the number of cleats above and / or below the annulus, the number of cleats engaged with the annulus, the amount of the implant is oversized to the anatomy, and / or the expected force exerted by the implant onto the anatomy. Additionally and / or alternatively, the predetermined implant deployment location and / or the desired implant deployment pose can include compensation for the phenomena of foreshortening where the implant changes length in the deployment sequence. By including this dynamic, an optimal deployment position of the desired implant deployment pose can be better captured, and simulations can better represent final implant outcomes

[0075] At 1008, at least one path can be developed for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with a surface of the anatomical model. The at least one path can include at least one articulation of the catheter at the at least one kinematic joint 1110 and at least one advancement motion 1112. The simulation can include performance of forward and / or backward kinematics of the flexion, rotation, and / or extension of each of the at least one kinematic joint and a position of each of the at least on kinematic joints and / or the implant along the at least one path at a time. The at least one path can be developed for a surgeon or technician to practice maneuvering through a portion of a patient’s heart that is traditionally challenging (e.g., requires multiple bends of the catheter to reach the predetermined implant deployment location). As an example, the simulation can be specifically configured with a centerline and boundary conditionsA0013395W001MDT-033926 WO ORD to focus on collision avoidance and to take into account the articulations (e.g., kinematic joint number and flexibility) of the catheter model. Collision avoidance can include avoiding the device model (catheter and / or un-deployed implant) contacting (or contacting with a damaging force, determined based on the materials and specific tissues) a portion of the ostium into the heart, any portion of the interior surface of the heart, and / or the implant deployment location. The at least one path can be developed based at least in part on a collision aware algorithm and / or an artificial intelligence reinforcement algorithm to avoid collisions and / or reduce collisions and / or collision force. For example, the collision aware algorithm can calculate finite element analysis physics between at least a portion of the device model and the at least the portion of the anatomical model to avoid collisions and / or reduce collisions and / or collision force. As another example, the artificial intelligence reinforcement algorithm can perform reduced order methods to estimate physics parameters of at least a portion of the device model and the at least the portion of the anatomical model to avoid collisions and / or reduce collisions and / or collision force.

[0076] FIG. 12 shows a method 1200 for planning a path for catheter control using an inverse solver and a solver that can loop until a final position and / or orientation is achieved (e.g., implant at desired final position and orientation). At 1202, the anatomy and device models can be simulated (as described in detail above) and at 1204 the initial path estimates can be formed 1204 based on the anatomy and device models. The initial path estimates can be, for instance, a discrete centerline of the atrial volume. The initial path estimates may in some instances, be output as a visualization (e.g., overlaying the anatomical model) and / or as steps. At 1206 the desired catheter output state can be determined for the initial path estimates and based on the device model. The desired catheter output state can be the current catheter state plus the change needed for the next step of the initial path estimate. At 1208, the desired catheter output state can be run through the inverse solver (e.g., solving state and steps as functions of the kinematics and physics of the joints of the catheter, as described in more detail above).

[0077] At 1210, control inputs and / or changes to the control inputs can be determined based on the outcome of the inverse solver. At 1212, the solver can be run with the control inputs and / or changed control inputs to determine the catheter state output with the step taken. At 1214, it can be determined if the new deviceA0013395W001MDT-033926 WO ORD position (e.g., catheter and / or implant) meets desired parameters (e.g., predetermined for avoiding collusions with the anatomical model, reducing collusions, and / or appropriate force of collision to cause no or minimal damage). If the new device position is within the desired parameters, then at 1216 the control inputs can be saved (e.g., in memory) as acceptable and the system can proceed to the next step of the estimated path and repeat. If the new device position is not within the desired parameters, then at 1218, the device model (e.g., catheter) can be reset to the previous state and a different path step can be attempted (e.g., smaller step size and / or with one or more constraints to the input control degrees of freedom). The method can then loop again with the smaller step and / or more constraints until the new device position is deemed appropriately within the desired parameters.

[0078] FIG. 13 shows a method 1300 for training a user of a catheter using the simulations described above in detail. For example, the method 1300 can be used to train students, technicians, doctors, or the like on procedures and / or new equipment. At 1302, the control inputs for a given simulation (e.g., created as described above in detail with the anatomical and device models) can be input into the system (e.g., system 100). The trainee can choose the inputs to move the device (e.g., catheter and implant) through at least a portion of the anatomy. At 1304 the simulation, including the solver, and a deterministic model of interactions can be solved for. At 1306 the catheter control outputs can be determined for at least the one step of the path based on the simulation (e.g., how the catheter reacts to the inputs selected by a trainee). At 1308, the navigation session results can be output (e.g., audibly, visually, to memory, and / or the like). Navigation session results can be partial results (for one or more steps of a procedure) and can include, success percentage, time to navigate, or the like.

[0079] At 1310, world state parameters and / or variables can be output (e.g., audibly, visually, to memory, and / or the like). World state parameters and / or variables can include, but are not limited to, closeness to target position / orientation, catheter dexterity reserve, internal system force(s), distance between one or more portions of the device model and the anatomical model, and force(s) on the anatomy (e.g., if a collision occurred). At 1312 action desirability can be determined (e.g., parameterization from 1310 can be rescaled for a loss function. At 1314, a reward loss function can be performed to determine what the parameters and variablesA0013395W001MDT-033926 WO ORD mean for navigation session successfulness (e.g., determining was implant positioned close enough to a target, was the next position and / or orientation of the device close enough to a target next position and / or orientation, did the device touch the anatomy model with too much force, or the like). The output of the reward / loss function can determine if a user passed a training module, needs to start over, performed one or more steps improperly, or the like. At 1316, a deep learning optimization can be performed on an output of the reward loss function to act as feedback in the training loop. And at 1318, the next step(s) can be predicted with a control network and may be fed back into the next possible control inputs (e.g., a previous step can limit the available inputs a trainee can have for a next step). The training method can loop until the session is ended and / or the procedure is completed successfully.V. Aspects

[0080] According to a first embodiment hereof, the present disclosure provides a system that can determine a path to reach a predetermined implant deployment location at a desired implant pose while minimizing potential damage to a patient. The system can include a display configured to display a graphical output and a controller in communication with the display. The controller can include a non- transitory memory configured to store instructions and a processor configured to execute the following instructions. Receive parameters including anatomical information, catheter information, and implant information. The anatomical information can include at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle, the catheter information can include at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter, and the implant information can include at least dimensionality of at least a portion of the implant. The instructions further include create an anatomical model of at least the portion of the heart and a device model. The anatomical model can include at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant, based on at least a portion of the anatomical information. The device model can be created based on the catheter information and the implant information and can include at least an exterior shape of the catheter, at least one kinematic joint of the catheter, and at least a reference point and / or a top plane ofA0013395W001MDT-033926 WO ORD the implant. The system can then simulate the device model moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model. The simulation can determine a desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location, and develop at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with without contacting a surface of the anatomical model, wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion. The desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose can be output (e.g., to the display, the memory, a controller of the catheter, or the like).

[0081] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the implant is at least one of a pacemaker, an ablation catheter, a coronary stent, or a renal denervation device.

[0082] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the system further comprises a user interface configured to receive at least one input comprising at least one parameter, at least one path variable, and / or the predetermined implant deployment location, wherein the user interface is communication with the controller.

[0083] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the sequence of images over the at least one cardiac cycle comprises a plurality of three-dimensional (3D) computed tomography images corresponding to a plurality of time points during the at least one cardiac cycle for at least one surface of the heart.

[0084] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the catheter information comprises at least one of: at least one two-dimensional (2D) fluoroscopy image of the catheter, at least one synthetic and / or simulated echo and / or ultrasound views, one or more mathematically determined shapes, positions, and / or articulation points of the catheter, one or more three-dimensional (3D) scans of the catheter, or a finite element analysis model of the catheter; and the implant information comprises atA0013395W001MDT-033926 WO ORD least one of: at least one two-dimensional (2D) fluoroscopy image of at least a portion of the implant, a mathematical determination of an aspect of the implant pose and / or one or more reference points on the implant, a 3D scan of the implant, or a finite element analysis model of the implant.

[0085] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the ostium into the heart is an ostium of an inferior vena cava (IVC), the at least the portion of the interior of the heart is the right side of the heart, and the implant deployment location is an annulus of a tricuspid valve.

[0086] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the ostium of the IVC is modeled as a minimum ostium in a plane as an initial boundary condition and the annulus of the tricuspid valve is modeled as a spline.

[0087] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the ostium into the heart is an ostium of a fossa ovalis, the at least the portion of the interior of the heart is at least a portion of the left side of the heart, and the implant deployment location is an annulus of the mitral valve.

[0088] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the system further outputs instructions to physically move the catheter and the implant on the at least one path.

[0089] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the system further comprises the catheter corresponding to the catheter of the device model and the implant corresponding to the implant of the device model, wherein the implant is removably attached to the catheter, wherein the controller automatically steers the catheter with the implant attached along the at least one path to the predetermined implant deployment location, wherein the implant is deployed in the implant deployment pose at the predetermined implant deployment location.

[0090] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the catheter of the device model has a same number of degrees of freedom as the catheter.

[0091] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the at least one path furtherA0013395W001MDT-033926 WO ORD comprises at least one variable, the at least one variable comprises: an advancement depth into the anatomical model, an inner flexion angle, an inner rotation angle, an inner advancement amount, an outer flexion angle, an outer rotation angle, a sheath rotation, a sheath translation, a system advancement quantity, and a deployment status.

[0092] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the instruction to simulate the device model moving through the at least the portion of the anatomical model towards the predetermined implant deployment location in the anatomical model are based at least in part on a collision aware algorithm and / or an artificial intelligence reinforcement algorithm to avoid collisions.

[0093] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the collision aware algorithm calculates finite element analysis physics between at least a portion of the device model and the at least the portion of the anatomical model.

[0094] In an aspect of the first embodiment, and in combination with any of the other aspects herein, the disclosure provides that the artificial intelligence reinforcement algorithm performs reduced order methods to estimate physics parameters of at least a portion of the device model and the at least the portion of the anatomical model.

[0095] According to a second embodiment hereof, the present disclosure provides a method for determining a path to reach a predetermined implant deployment location at a desired implant pose while minimizing potential damage to a patient. The system comprising at least a processor can receive parameters that can include anatomical information, catheter information, and implant information. The anatomical information can include at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle. The catheter information can include at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter. The implant information can include at least dimensionality of at least a portion of the implant. An anatomical model of at least the portion of the heart can be created that can include at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant. The anatomical model of the at least the portion of the heart can be based on at least a portion of theA0013395W001MDT-033926 WO ORD anatomical information. A device model can be created based on the catheter information and the implant information. The device model can include at least an exterior shape of the catheter, at least one kinematic joint of the catheter, and at least a reference point of the implant. The device model can be simulated moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model. The simulation can determine a desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location. The simulation can also develop at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with a surface of the anatomical model, wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion. The desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose can be output (e.g., to a display, a memory, a controller of the catheter, or the like).

[0096] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the sequence of images over the at least one cardiac cycle comprises a plurality of three-dimensional (3D) computed tomography images corresponding to a plurality of time points during the at least one cardiac cycle for at least one surface of the heart.

[0097] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the creating the device model further comprises modeling the at least an exterior shape of the catheter, the at least one kinematic joint of the catheter, and / or the at least a reference point of the implant with statistical shape models, device specific modeling, and / or Al assisted segmentation.

[0098] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the desired implant deployment pose comprises: a trajectory of the implant, an angle of a reference point of the implant relative to the predetermined implant deployment location, a position of the implant, and / or a depth of the implant within at least the portion of the heart relative to the predetermined implant deployment location.A0013395W001MDT-033926 WO ORD

[0099] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the method further comprises optimizing the implant deployment pose.

[0100] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the simulating further comprises performing forward and / or backward kinematics of the flexion, rotation, and / or extension of each of the at least one kinematic joints and a position of each of the at least on kinematic joints and / or the implant along the at least one path at a time.

[0101] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that a Jacobian matrix relates changes in the position of the at least one kinematic joint to changes in a current pose of the implant.

[0102] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the method further comprises outputting, by the system, instructions to physically move the catheter and the implant along the at least one path.

[0103] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the method further comprises outputting, by the system, a graphical representation of the anatomical model, the device model, and / or at least one path for the device model in the anatomical model where collisions with the at least the portion of the heart are avoided.

[0104] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the method is used to validate catheter designs and / or implant designs, train medical professionals and / or technicians, test patient specific procedures, determine suitability of a patient for the procedure, and / or automatically control steering of a physical catheter.

[0105] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the outputting the at least one path further comprises selecting at least one path to minimize interference with the anatomy with collision bounds to minimize and / or avoid injury to the anatomy.

[0106] In an aspect of the second embodiment, and in combination with any of the other aspects herein, the disclosure provides that the catheter information furtherA0013395W001MDT-033926 WO ORD comprises an interior shape of the catheter and / or a volumetric representation of an interior shape of the catheter.

[0107] From the above description, those skilled in the art will perceive improvements, changes, and modifications. Such improvements, changes and modifications are within the skill of one in the art and are intended to be covered by the appended claims. All patents, patent applications, and publications cited herein are incorporated by reference in their entirety.

Claims

A0013395W001MDT-033926 WO ORDWhat is claimed is:1 . A system comprising: a display configured to display a graphical output; and a controller in communication with the display, the controller comprising: a non-transitory memory configured to store instructions, and a processor configured to execute the instructions to: receive parameters, the parameters comprising: anatomical information, wherein the anatomical information comprises at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle, catheter information, wherein the catheter information comprises at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter, and implant information, wherein the implant information comprises at least dimensionality of at least a portion of the implant, create an anatomical model of at least the portion of the heart, comprising at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant, based on at least a portion of the anatomical information, create a device model based on the catheter information and the implant information, wherein the device model comprises at least an exterior shape of the catheter, at least one kinematic joint of the catheter, and at least a top plane of the implant, simulate the device model moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model to: determine a desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location, andA0013395W001MDT-033926 WO ORD develop at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with a surface of the anatomical model wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion; and output the desired implant deployment pose at the implant deployment location and the at least one path to reach the implant deployment location with the implant in the implant deployment pose.

2. The system of claim 1 , wherein the implant is at least one of a pacemaker, an ablation catheter, a coronary stent, or a renal denervation device.

3. The system of any preceding claim, further comprising a user interface configured to receive at least one input comprising at least one parameter, at least one path variable, and / or the predetermined implant deployment location, wherein the user interface is communication with the controller.

4. The system of any preceding claim, wherein the sequence of images over the at least one cardiac cycle comprises a plurality of three-dimensional (3D) computed tomography images corresponding to a plurality of time points during the at least one cardiac cycle for at least one surface of the heart.

5. The system of any preceding claim, wherein: the catheter information further comprises at least one of: at least one two-dimensional (2D) fluoroscopy image of the catheter, at least one synthetic and / or simulated echo and / or ultrasound views, one or more mathematically determined shapes, positions, and / or articulation points of the catheter, one or more three-dimensional (3D) scans of the catheter, or a finite element analysis model of the catheter; and the implant information comprises at least one of:A0013395W001MDT-033926 WO ORD at least one two-dimensional (2D) fluoroscopy image of at least a portion of the implant, a mathematical determination of an aspect of the implant pose and / or one or more reference points on the implant, a 3D scan of the implant, or a finite element analysis model of the implant.

6. The system of any preceding claim, wherein the ostium into the heart is an ostium of an inferior vena cava (IVC), the at least the portion of the interior of the heart is the right side of the heart, and the implant deployment location is an annulus of a tricuspid valve, wherein the ostium of the IVC is modeled as a minimum ostium in a plane as an initial boundary condition and the annulus of the tricuspid valve is modeled as a spline.

7. The system of claim 1 , 2, 3, 4, or 5, wherein the ostium into the heart is an ostium of a fossa ovalis, the at least the portion of the interior of the heart is at least a portion of the left side of the heart, and the implant deployment location is an annulus of the mitral valve.

8. The system of any preceding claim, wherein the system further outputs instructions to physically move the catheter and the implant on the at least one path and wherein the system further comprises the catheter corresponding to the catheter of the device model and the implant corresponding to the implant of the device model, wherein the implant is removably attached to the catheter, wherein the controller automatically steers the catheter with the implant attached along the at least one path to the predetermined implant deployment location and the catheter has a same number of degrees of freedom as the catheter, and wherein the implant is deployed in the implant deployment pose at the predetermined implant deployment location.

9. The system of any preceding claim, wherein the at least one path further comprises at least one variable, the at least one variable comprises: anA0013395W001MDT-033926 WO ORD advancement depth into the anatomical model, an inner flexion angle, an inner rotation angle, an inner advancement amount, an outer flexion angle, an outer rotation angle, a sheath rotation, a sheath translation, a system advancement quantity, and a deployment status.

10. The system of any preceding claim, wherein the instruction to simulate the device model moving through the at least the portion of the anatomical model towards the predetermined implant deployment location in the anatomical model are based at least in part on a collision aware algorithm to avoid collisions, wherein the collision aware algorithm calculates finite element analysis physics between at least a portion of the device model and the at least the portion of the anatomical model, and / or wherein the instruction to simulate the device model moving through the at least the portion of the anatomical model towards the predetermined implant deployment location in the anatomical model are based at least in part on an artificial intelligence reinforcement algorithm to avoid collisions, wherein the artificial intelligence reinforcement algorithm performs reduced order methods to estimate physics parameters of at least a portion of the device model and the at least the portion of the anatomical model.

11. A computer-implemented method to determine a desired implant deployment pose at a predetermined implant deployment location and at least one path to reach the predetermined implant deployment location, the method comprising: receiving, by a system comprising a processor, parameters, the parameters comprising: anatomical information, wherein the anatomical information comprises at least one image from a sequence of images of at least a portion of a heart over at least one cardiac cycle, catheter information, wherein the catheter information comprises at least external dimensional information of a catheter and kinematic joint information representing articulations of the catheter, and implant information, wherein the implant information comprises at least dimensionality of at least a portion of the implant;A0013395W001MDT-033926 WO ORD creating, by the system, an anatomical model of at least the portion of the heart, comprising at least an ostium into the heart, at least a portion of an interior surface of the heart, and a predetermined deployment location of the implant, based on at least a portion of the anatomical information; creating, by the system, a device model based on the catheter information and the implant information, wherein the device model comprises at least an exterior shape of the catheter, at least one kinematic joint of the catheter, and at least a reference point of the implant; simulating, by the system, the device model moving through at least a portion of anatomical model towards a predetermined implant deployment location in the anatomical model by: determining the desired implant deployment pose, comprising a position and orientation of at least the top plane of the implant at the predetermined implant deployment location, and developing the at least one path for the device model to take towards the predetermined implant deployment location to reach the desired implant deployment pose while reducing and / or avoiding damaging contact with a surface of the anatomical model, wherein the at least one path comprises at least one articulation of the catheter at the at least one kinematic joint and at least one advancement motion; and outputting, by the system, the desired implant deployment pose at the predetermined implant deployment location and the at least one path to reach the predetermined implant deployment location with the implant in the desired implant deployment pose.

12. The computer-implemented method of claim 1 1 , wherein the creating the device model further comprises modeling the at least an exterior shape of the catheter, the at least one kinematic joint of the catheter, and / or the at least a reference point of the implant with statistical shape models, device specific modeling, and / or Al assisted segmentation.

13. The computer-implemented method of claim 1 1 or 12, wherein the simulating further comprises performing forward and / or backward kinematics of the flexion, rotation, and / or extension of each of the at least one kinematic joint and a position ofA0013395W001MDT-033926 WO ORD each of the at least on kinematic joints and / or the implant along the at least one path at a time.

14. The computer-implemented method of claim 1 1 , 12, or 13, further comprising: outputting, by the system, instructions to physically move the catheter and the implant along the at least one path; and / or outputting, by the system, a graphical representation of the anatomical model, the device model, and / or at least one path for the device model in the anatomical model where collisions with the at least the portion of the heart are avoided.

15. The method of claim 1 1 , 12, 13, or 14, wherein the outputting the at least one path further comprises selecting at least one path to minimize interference with the anatomy with collision bounds to minimize and / or avoid injury to the anatomy.

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