System and method for navigating device through path to target location

Abstract

A method of delivering an elongate medical device along a path to a target location using a catheter procedure system includes generating a cover for the path, tracking a location of a distal portion of the elongate medical device based on a set of real-time images, and determining a remaining path length based at least on the location of the distal portion of the elongate medical device. The remaining path length is a distance between the distal portion of the elongate medical device and the target location. The remaining path length decreases as the distal portion of the elongate medical device approaches the target location. The method further includes updating the remaining path length during movement of the elongate medical device; determining if the distal portion of the elongate medical device deviates from the path; adjusting the position of the elongate medical device if the distal portion of the elongate medical device deviates from the path; monitoring a distal portion of the elongate medical device in a real-time image set to identify prolapse; and advancing the elongate medical device to the target location at a velocity determined based at least on the remaining path length.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application Serial No. 16 / 175,333, filed on October 30, 2018, entitled “SYSTEM AND METHOD FOR NAVIGATINGA DEVICE THROUGH A PATH TO A TARGET LOCATION”, and is incorporated herein by reference in its entirety. This application is a divisional application, the parent application number of which is 201980072512.X, the filing date is October 22, 2019, and the invention name is “SYSTEM AND METHOD FOR NAVIGATINGA DEVICE THROUGH A PATH TO A TARGET LOCATION”. Technical Field

[0002] The present invention relates generally to the field of catheter procedure systems, and more particularly to systems and methods for navigating a device (eg, an elongated medical device) through a pathway (eg, a vessel) to a target location. Background Art

[0003] Catheter (and other elongated medical devices) can be used for many minimally invasive medical procedures, for the diagnosis and treatment of various vascular diseases, including neurovascular intervention (NVI), percutaneous coronary intervention (PCI) and peripheral vascular intervention (PVI), also known as neurointerventional surgery. These procedures generally include navigation guide wire through the vascular system, and advance the working catheter via the guide wire to deliver treatment. The catheter insertion procedure begins by using standard percutaneous techniques, using a sheath or guide catheter to obtain access to the appropriate vascular (such as, artery or vein). Then, the sheath or guide catheter is advanced to the main position on the diagnostic guide wire, such as the internal carotid artery for NVI, the coronary artery ostium for PCI or the superficial femoral artery for PVI. Then, the guide wire that navigation is suitable for the vascular system is navigated to the target position in the vascular system by the sheath or guide catheter. In some cases, such as in a tortuous anatomical structure, a support catheter or a microcatheter is inserted on the guide wire to help navigate the guide wire. The doctor or operator can use an imaging system (e.g., a fluoroscope) to obtain a movie with contrast injection and select a fixed frame to use as a roadmap to navigate the guidewire or catheter to the target location, such as a lesion. While the doctor delivers the guidewire or catheter device, a contrast-enhanced image is also obtained so that the doctor can verify that the device is moving along the correct path to the target location. While observing the anatomical structure using fluoroscopy, the doctor manipulates the proximal end of the guidewire or catheter to guide the distal tip toward the lesion into the appropriate vessel and avoid advancing into the side branch.

[0004] Robotic catheter procedure systems have been developed that can be used to help doctors perform catheterization procedures, such as, for example, NVI, PCI, and PVI. Examples of neurovascular intervention (NVI) catheter procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the case of acute ischemic stroke. In NVI, doctors use a robotic system to deliver treatment to restore normal blood flow by manipulating neurovascular guidewires and microcatheters to obtain access to the lesion. This access is achieved by a sheath or guide catheter, but an intermediate catheter may also be required for a more distant area, or sufficient support may be provided for the microcatheter and guidewire. Depending on the type and treatment of the lesion, the distal tip of the guidewire is navigated into the lesion or through the lesion. In order to treat an aneurysm, the microcatheter is advanced into the lesion, and the guidewire is removed, and several coils are deployed into the aneurysm by the microcatheter and used to embolize the aneurysm. In order to treat an arteriovenous malformation, a liquid embolic agent is injected into the malformation via a microcatheter. Mechanical thrombectomy for treating vascular obstruction can be achieved by suction or using a stent retriever. Suction can be performed directly through the microcatheter or can be performed using a larger bore suction catheter. Once the suction catheter is at the lesion, negative pressure is applied to remove the clot through the catheter. Alternatively, the clot can be removed by deploying a stent retriever through the microcatheter. Once the clot has been integrated into the stent retriever, the clot is retrieved by retracting the stent retriever and microcatheter into the guide catheter.

[0005] In PCI, physicians use a robotic system to gain access to the lesion by manipulating a coronary guidewire to deliver treatment and restore normal blood flow. This access is achieved by placing a guide catheter in the coronary ostium. The distal tip of the guidewire is navigated past the lesion, and for complex anatomies, a microcatheter may be used to provide adequate support for the guidewire. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. The lesion may require preparation prior to stent implantation, by delivering a balloon for lesion pre-dilation, or by performing an atherectomy using, for example, a laser or rotational atherectomy catheter and a balloon over the guidewire. Diagnostic imaging and physiological measurements may be performed using an imaging catheter or FFR measurements to determine appropriate treatment.

[0006] In PVI, physicians use a robotic system to deliver treatment and restore blood flow through techniques similar to NVI and PVI. The distal tip of a guidewire is navigated past the lesion, and a microcatheter may be used to provide adequate support for the guidewire for complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon to the lesion. As with PCI, lesion preparation and diagnostic imaging may also be used.

[0007] There are several challenges when performing a catheter procedure, either manually or via a robotic catheter procedure system. For example, the path of a device through the vasculature may change during a physiological cycle (such as a cardiac cycle or a respiratory cycle), which may extend the amount of time required to successfully navigate the device. Additionally, the amount of contrast media used during device navigation may adversely affect the patient (e.g., if there is more than one lesion that requires treatment). It would be desirable to provide a system and method for navigating a device (e.g., an elongated medical device) through a path (e.g., a vasculature) to a target location that reduces the procedure time and reduces the amount of contrast media used during the procedure. Summary of the invention

[0008] According to an embodiment, a method for delivering an elongated medical device to a target location along a path using a catheter procedural system includes: generating a mask of the path; tracking the position of a distal portion of the elongated medical device based on a set of real-time images; determining a remaining path length based at least on the position of the distal portion of the elongated medical device, the remaining path length being the distance between the distal portion of the elongated medical device and the target location, wherein the remaining path length decreases as the distal portion of the elongated medical device approaches the target location; updating the remaining path length during movement of the elongated medical device; determining whether the distal portion of the elongated medical device deviates from the path; adjusting the position of the elongated medical device if the distal portion of the elongated medical device deviates from the path; and advancing the elongated medical device to the target location at a speed determined at least based on the remaining path length.

[0009] According to another embodiment, a system for delivering an elongated medical device along a path to a target location includes an imaging system and a catheter procedure system coupled to the imaging system. The catheter procedure system includes a bedside system and a workstation coupled to the bedside system, the bedside system including an elongated medical device and a drive assembly configured to drive the elongated medical device. The workstation includes a user interface and a controller, the controller being coupled to the bedside system, the user interface, and the imaging system. The controller is programmed to generate a mask of the path; track the position of a distal portion of the elongated medical device based on a set of real-time images acquired by the imaging system; determine a remaining path length based at least on the position of the distal portion of the elongated medical device, the remaining path length being the distance between the distal portion of the elongated medical device and the target location, wherein the remaining path length decreases as the distal portion of the elongated medical device approaches the target location; update the remaining path length during movement of the elongated medical device; determine whether the distal portion of the elongated medical device deviates from the path; if the distal portion of the elongated medical device deviates from the path, adjust the position of the distal portion of the elongated medical device; and use the drive assembly to advance the elongated medical device toward the target location at a speed determined based at least on the remaining path length.

[0010] According to another embodiment, a method for generating a mask of a calculated path to a target position and tracking the position of a slender medical device moving along the path, the method comprising: acquiring a set of contrast-enhanced images of a region of interest; generating a vascular image based on at least one image from the set of contrast-enhanced images; identifying a source point and a target point on the vascular image; calculating the vascular path from the source point to the target point based at least on the set of contrast-enhanced images; generating a path mask for the vascular path; determining whether at least one sub-vessel is connected to the vascular path based at least on the contrast agent flow in the set of contrast-enhanced images; and if at least one sub-vessel is connected to the path, generating a sub-vessel mask for the at least one sub-vessel; applying and displaying the path mask on an image associated with the path mask; and if it is determined that at least one sub-vessel is connected to the vascular path, applying and displaying the sub-vessel mask for the at least one sub-vessel on an image associated with the path mask.

[0011] According to another embodiment, a system for generating a mask of a calculated path to a target location and tracking the position of an elongated medical device moving along the path includes an imaging system, a workstation os coupled to the imaging system, the workstation including a user interface, at least one display; and a controller coupled to the user interface, the at least one display, and the imaging system. The controller is programmed to: receive a set of contrast-enhanced images of a region of interest from the imaging system; generate a vascular image based on at least one image from the set of contrast-enhanced images; receive identification of a source point and a target point on the vascular image; calculate a vascular path from the source point to the target point based at least on the set of contrast-enhanced images; determine whether at least one sub-vessel is connected to the vascular path based at least on contrast agent flow in the set of contrast-enhanced images; and generate a path mask for the vascular path. If at least one sub-vessel is connected to a vascular path, a sub-vessel cover is generated for the at least one sub-vessel; and the path cover is displayed on an image associated with the path cover on a display, and if at least one sub-vessel is connected to the vascular path, a sub-vessel cover for the at least one sub-vessel is displayed on an image associated with the path cover on a display. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which reference numerals indicate similar parts and in which: Figure 1 is a perspective view of an exemplary catheter procedure system according to an embodiment; Figure 2 is a schematic block diagram of an exemplary catheter procedure system according to an embodiment; Figure 3 is an isometric view of an exemplary bedside system of a catheter procedure system according to an embodiment; Figure 4 illustrates a method for path and navigation visualization of an elongated medical device according to an embodiment; Figure 5 A method for identifying a path through a vessel according to an embodiment is illustrated; Figure 6 illustrates identification of exemplary source and target points on a vascular image according to an embodiment; Figure 7 illustrates exemplary pathway covers and sub-vessel covers according to embodiments; Figure 8 A method for delivering an elongated medical device to a target location according to an embodiment is illustrated; Fig. 9 An exemplary display illustrating a path and tracking a guidewire traversing the path is shown in accordance with an embodiment; Fig.10 illustrates exemplary types of wire prolapse according to embodiments; Fig.11 illustrates first and second two-dimensional views of a path and a generated three-dimensional path according to an embodiment; Fig. 12A illustrating a vasculature having sub-vessels and branches that pass through or connect via bifurcations to vessels in the identified vessel; and Fig. 12B The diagram shows the vessel mask and sub-vessel mask after they have been applied and displayed. Fig. 12A of the vascular system. DETAILED DESCRIPTION

[0013] Figure 1 is a perspective view of an exemplary catheter procedure system according to an embodiment. Figure 1In the present invention, the catheter procedure system 100 can be used to perform catheter-based medical procedures (e.g., neurovascular intervention (NVI), percutaneous intervention (PCI), peripheral vascular intervention (PVI)). Catheter-based medical procedures can include diagnostic catheterization procedures, during which one or more catheters are used to help diagnose a patient's disease. For example, in one embodiment of a catheter-based diagnostic procedure, a contrast medium is injected into one or more coronary arteries via a catheter, and an image of the patient's heart is taken. Catheter-based medical procedures can also include catheter-based therapeutic procedures (e.g., angioplasty, stent placement, peripheral vascular disease treatment, clot removal, arteriovenous malformation treatment, aneurysm treatment, etc.), during which a catheter is used to treat the disease. However, it should be noted that those skilled in the art will recognize that certain specific percutaneous intervention devices or components (e.g., guidewire type, catheter type, etc.) will be selected based on the type of procedure to be performed. The catheter procedure system 100 is capable of performing any number of catheter-based medical procedures, with only minor adjustments required to accommodate the specific percutaneous intervention device to be used in the procedure. In particular, although the embodiments of the catheter procedure system 100 described herein are primarily explained with reference to the diagnosis and / or treatment of coronary artery disease, the catheter procedure system 100 can be used to diagnose and / or treat any type of disease or condition that can be diagnosed and / or treated via a catheter-based procedure.

[0014] The catheter procedure system 100 includes a laboratory unit 106 and a workstation 116. The catheter procedure system 100 includes a robotic catheter system (shown as a bedside system 110) that is located within the laboratory unit 106 adjacent to a patient 102. The patient 102 is supported on a table 108. Typically, the bedside system 110 can be equipped with appropriate percutaneous interventional devices or other components (e.g., guidewires, guide catheters, microcatheters, embolic coils, working catheters such as balloon catheters, stent delivery systems, aspiration catheters and atherectomy catheters, contrast media, drugs, diagnostic catheters, etc.) to allow a user to perform catheter-based medical procedures via the robotic system by operating various controls (such as controls located at the workstation 116). The bedside system 110 may include any number of components and / or combinations of components to provide the bedside system 110 with the functionality described herein. The bedside system 110 includes, in particular, a drive assembly 114 (e.g., a box) supported by a robotic arm 112, which is used to advance a guide wire into a guide catheter placed in an artery of the patient 102, or to advance other elongated medical devices (e.g., a catheter, a balloon catheter, a stent delivery system, etc.) into the body of the patient 102.

[0015] The bedside system 110 is in communication with the workstation 116, thereby allowing signals generated by user inputs to the workstation 116 to be transmitted to the bedside system 110 to control various functions of the bedside system 110. The bedside system 110 may also provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to the workstation 116. The bedside system 110 may communicate with the workstation 116 via the communication link 140 ( Figure 2 The communication link may be a wireless connection, a cable connection, or any other means capable of allowing communication to occur between the workstation 116 and the bedside system 110. In an embodiment, the bedside system 110 and the workstation 116 are remote from each other, for example, in different rooms in the same building, in different buildings in the same city, or in different cities. In another embodiment, multiple workstations 116 may be connected to the bedside system 110 and located remote from the bedside system 110.

[0016] The workstation 116 includes a user interface 126 that is configured to receive user input to operate various components or systems of the catheter procedure system 100. The user interface 126 includes controls 118 that allow a user to control the bedside system 110 to perform a catheter-based medical procedure. For example, the controls 118 can be configured to cause the bedside system 110 to perform various tasks (e.g., to advance, retract, or rotate a guidewire; advance, retract, or rotate a working catheter; advance, retract, or rotate a microcatheter; advance, retract, or rotate a guide catheter; expand or deflate a balloon located on a catheter; position and / or deploy a stent; inject contrast media into a catheter; inject a drug into a catheter; or perform any other function that can be performed as part of a catheter-based medical procedure) using various drive mechanisms to cause movement (e.g., axial and rotational movement) of components of the bedside system 110 including the percutaneous interventional devices. In embodiments, drive assembly 114, user interface 126, and / or controls 118 are used to manipulate the proximal end of a guidewire or catheter to direct the distal end of the device toward a target location into an appropriate vessel and avoid advancement into side branches.

[0017] In an embodiment, the control 118 includes a touch screen 124, one or more joysticks 128 and buttons 130, 132. The joystick 128 can be configured to advance, retract or rotate various components and percutaneous interventional devices, such as, for example, a guide wire, a guide catheter, a microcatheter or a working catheter. Buttons 130, 132 may include, for example, an emergency stop button and a multiplier button. When the emergency stop button is pressed, a relay is triggered to cut off the power supply to the bedside system 110. The multiplier button is used to increase or decrease the movement speed of the associated components in response to the manipulation of the control 118. In one embodiment, the control 118 may include one or more controls or icons (not shown) displayed on the touch screen 124, which, when activated, cause the operation of the components of the catheter procedure system 100. The control 118 may also include a balloon or stent control, which is configured to expand or contract balloons and / or stents. Each control may include one or more buttons, joysticks, touch screens, etc., which may be desirable for controlling a specific component dedicated to the control. Additionally, touch screen 124 may display one or more icons (not shown) associated with various portions of controls 118 or various components of catheter procedure system 100 .

[0018] The user interface 126 may include a first monitor or display 120 and a second monitor or display 122. The first monitor 120 and the second monitor 122 may be configured to display information or patient-specific data to a user located at the workstation 116. For example, the first monitor 120 and the second monitor 122 may be configured to display image data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.). In addition, the first monitor 120 and the second monitor 122 may be configured to display procedure-specific information (e.g., procedure duration, catheter or guidewire position, volume of medication or contrast agent delivered, etc.). The monitor 120 and the monitor 122 may be configured to display information about the position of the guide catheter. Furthermore, the monitor 120 and the monitor 122 may be configured to display information to provide functionality associated with the controller 134 (in Figure 2 In another embodiment, the user interface 126 includes a single screen that is large enough to display one or more of the display components and / or touch screen components discussed herein.

[0019] The catheter procedure system 100 also includes an imaging system 104 located within the laboratory unit 106. The imaging system 104 can be any medical imaging system that can be used in conjunction with a catheter-based medical procedure (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, the imaging system 104 is a digital x-ray imaging device that communicates with the workstation 116. In one embodiment, the imaging system 104 can include a C-arm (not shown) that allows the imaging system 104 to be partially or completely rotated around the patient 102 in order to obtain images at different angular positions relative to the patient 102 (e.g., sagittal view, caudal view, anteroposterior view, etc.).

[0020] The imaging system 104 can be configured to take x-ray images of appropriate areas of the patient 102 during a particular procedure. For example, the imaging system 104 can be configured to take one or more x-ray images of the heart to diagnose a heart condition. The imaging system 104 can also be configured to take one or more x-ray images (e.g., fluoroscopy) (e.g., real-time images) during a catheter-based medical procedure to help a user of the workstation 116 properly position a guidewire, guide catheter, microcatheter, stent, etc. during the procedure. The one or more images can be displayed on the first monitor 120 and / or the second monitor 122. In particular, the images can be displayed on the first monitor 120 and / or the second monitor 122 to allow the user, for example, to accurately move a guide catheter into an appropriate position.

[0021] refer to Figure 2 , a block diagram of a catheter procedure system 100 according to an exemplary embodiment is shown. The catheter procedure system 100 may include a control system, shown as a controller 134. The controller 134 may be part of a workstation 116. The controller 134 may generally be an electronic control unit suitable for providing the catheter procedure system 100 with the various functions described herein. For example, the controller 134 may be an embedded system, a dedicated circuit, a general purpose system programmed with the functions described herein, etc. The controller 134 communicates with one or more bedside systems 110, controls 118, monitors 120 and 122, imaging systems 104, and patient sensors 136 (e.g., an electrocardiogram ("ECG") device, an electroencephalogram ("EEG") device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). In various embodiments, the controller 134 is configured to generate control signals based on user interaction with the controls 118 and / or based on information accessible to the controller 134 so that a medical procedure can be performed using the catheter procedure system 100. Additionally, the controller 134 may communicate with a hospital data management system or hospital network 142 and one or more additional output devices 138 (eg, printer, disk drive, CD / DVD burner, etc.).

[0022] Communication between the various components of the catheter procedure system 100 can be achieved via a communication link 140. The communication link 140 can be a dedicated wired or wireless connection. The communication link 140 can also represent communication through a network. The catheter procedure system 100 can be connected or configured to include any other system and / or device not explicitly shown. For example, the catheter procedure system 100 can include an IVUS system, an image processing engine, a data storage and archiving system, an automatic balloon and / or stent expansion system, a drug injection system, a drug tracking and / or recording system, a user log, an encryption system, a system that limits access or use of the catheter procedure system 100, etc.

[0023] As described above, the controller 134 communicates with the bedside system 110 and can provide control signals to the bedside system 110 to control the operation of the motor and the drive mechanism for driving the percutaneous interventional device (e.g., a guidewire, a catheter, etc.). The bedside system 110 may include, for example, a guidewire axial drive mechanism that provides advancement and / or retraction of the guidewire, a working catheter axial drive mechanism that provides advancement and / or retraction of the working catheter, and a guidewire rotation drive mechanism configured to rotate the guidewire about its longitudinal axis. In one embodiment, the various drive mechanisms are housed in the drive assembly 114 (e.g., Figure 1 shown).

[0024] Figure 3 is an isometric view of an exemplary bedside system of a catheter procedure system according to an embodiment. Figure 3 In the embodiment of the present invention, a bedside system 210 includes a robotic mechanism 212 that can be used to robotically move an elongated medical device (e.g., a percutaneous interventional device or other component). The robotic mechanism 212 is movable relative to a base 214. The robotic mechanism 212 includes a robotic drive base 220 that is movable relative to the base 214 and a drive assembly 222 that is operably fixed to the robotic drive base 220. Figure 3 , the drive assembly 222 is shown as a box that houses various drive mechanisms for driving a percutaneous device and can be equipped with a percutaneous device. In one embodiment, the base 214 is fixed to an articulated arm 224, which allows a user to position the robotic mechanism 212 close to the patient. In an embodiment, the base 214 is the distal portion of the articulated arm 224. The articulated arm 224 is fixed to the bed by a rail clamp or a bed clamp 226. By manipulating the articulated arm 224, the base 214 is placed in a fixed position relative to the patient lying on the bed. Once the desired position of the robotic mechanism 212 relative to the patient is set, the joint of the articulated arm 224 can be locked.

[0025] As used herein, the direction distal is the direction toward the patient, and the direction proximal is the direction away from the patient. The terms "upper" and "upper" refer to the general direction away from the direction of gravity, and the terms "lower," "lower," and "below" refer to the general direction of gravity. The term "front" refers to the side of the robotic mechanism that faces the user and away from the articulated arm. The term "rear" refers to the side of the robotic mechanism that is closest to the articulated arm. The term "inward" refers to the interior portion of a feature. The term "outward" refers to the outward portion of a feature.

[0026] The bedside system 210 also includes a flexible track 216 movable along a rigid guide track 218 having a non-linear portion. The flexible track 216 includes a proximal end 228 and a distal end 230. The flexible track 216 supports an elongated medical device, such as a guide catheter, so that the guide catheter can be advanced into the patient without buckling. In one embodiment, the drive assembly 222 includes a structure defining the rigid guide 218. In another embodiment, the base 214, alone or in combination with the drive assembly 222, includes a structure defining the rigid guide 218.

[0027] The flexible track 216 is initially positioned within the rigid guide 218 by feeding the distal end 230 of the flexible track 216 into the proximal opening 234 of the rigid guide 218 until the distal end 230 of the flexible track 216 extends beyond the collar 258 of the rigid guide 218. The collar 258 is formed at the distal end of the rigid guide 218. The distal end 230 of the flexible track 216 is operably connected and secured to the sheath clip 232, which is releasably connected to the drive assembly 222. The rigid guide 218 includes a linear portion beginning at the proximal opening 234 and a non-linear portion. In one embodiment, the non-linear portion is an arcuate portion having at least one inflection point.

[0028] To perform the procedure, the user pulls the sheath clip 232 away from the drive assembly 222 in a direction along the longitudinal axis 256 until the distal end 262 of the sheath clip 232 is in close proximity to the patient. In one embodiment, an introducer (not shown) is fixed to the distal end 262 of the sheath clip 232. An introducer is a device that is fixed to the patient to forcibly position the introducer to the patient, thereby allowing an elongated medical device (such as a guide catheter, a guidewire, and / or a working catheter) to be inserted into or removed from the patient's body with minimal tissue damage to the patient. Once the operator has pulled the sheath clip 232 and the accompanying flexible track 216 toward the patient, so that the introducer is in close proximity to the patient, the flexible track 216 is locked in place by the locking clamp 236. The locking clamp 236 secures the flexible track 216 to the base 214 so that a portion of the flexible track 216 is in a fixed position relative to the bed and the patient is at the extent that the patient is lying on the bed.

[0029] In one type of interventional procedure, a guide catheter (not shown) is inserted into the femoral artery of the patient through an introducer and positioned close to the coronary ostium of the patient's heart. The guide catheter maintains a linear position along its longitudinal axis 256 in the drive assembly 222 and maintains a certain distance at the distal end of the drive assembly 222. In one embodiment, the longitudinal axis 256 corresponds to the longitudinal axis of the drive assembly 222. In medical procedures such as percutaneous coronary intervention (PCI), a guide catheter (not shown) is used to guide an elongated medical device such as a guidewire and a balloon stent catheter into the patient's body to perform, for example, exploratory diagnosis or treatment of stenosis in the patient's vascular system. As described above, the distal end of the guide catheter can be placed in the coronary ostium of the patient's heart. The robot mechanism 212 drives the guidewire and / or working catheter (such as a balloon stent catheter) in and out of the patient. The guidewire and working catheter are driven in the guide catheter between the distal end of the robot mechanism 212 and the patient. In one embodiment, longitudinal axis 256 is the axis about which drive assembly 222 causes the guidewire to rotate, and the axis along which drive assembly 222 drives the guidewire and drives a working catheter (such as a balloon stent catheter) along its longitudinal axis.

[0030] Figure 4 A method for path and navigation visualization of an elongated medical device according to an embodiment is illustrated. At block 402, a path through a vascular system is identified or detected. In one embodiment, the path is a path through one or more vessels to a target location (e.g., a lesion). Figure 5 A method for identifying a path through a vessel according to an embodiment is illustrated. At block 502, an imaging system (e.g., Figure 1 The imaging system 104 shown in the figure captures a set of images or image data of a region of interest. In an embodiment, the image is a contrast enhanced image obtained by injecting a contrast agent or medium into the patient before and / or during image acquisition. In an embodiment, the set of images may include images acquired at one or more views of the region of interest (e.g., a sagittal view, a caudal view, an anterior-posterior view, etc.). In various embodiments, the set of images may be acquired during at least one phase of a physiological cycle, such as a cardiac cycle or a respiratory cycle. The following description herein will relate to an exemplary cardiac cycle. For example, image data for the set of images may be acquired during a single phase of the cardiac cycle, during multiple phases of the cardiac cycle, or during all phases of the cardiac cycle. Information about the state of the physiological cycle may be provided by patient sensors (e.g., Figure 2Patient sensor 136 shown) such as, for example, an ECG or EEG for the cardiac cycle. At box 504, a vascular image is generated based on at least the set of acquired contrast enhanced images. In one embodiment, the vascular image is a two-dimensional image. For example, a two-dimensional vascular image can be generated by performing vascular extraction from at least one image of the set of images. In an embodiment, if the set of images includes more than one view, the best view can be selected from the set of images. In one embodiment, eigenvalues ​​of the image Hessian can be used as a "vascularity" measure, such as Frangi filtering. Additional filtering can be performed based on object regions (e.g., filtering out objects with small shapes) and non-linear objects (e.g., filtering out objects that are not similar to linear shapes). A control system or controller (e.g., Figure 2 The controller 134 shown may be configured to generate a two-dimensional vascular image as described above.

[0031] At block 506, a source point or location and a target point or location are identified on the vascular image. Figure 6 Identification of exemplary source and target points on a vascular image according to an embodiment is illustrated. Figure 6 In the embodiment of the present invention, a source point or location 604 and a target point or location 606 are identified on a vessel image 602. In one embodiment, the source point or location is the starting point of the path, such as a coronary artery ostium or the distal end of a guide catheter. The target point or location can be, for example, a lesion in the vessel or a point before or past the lesion in the vessel. The source point 604 and the target point 606 can be displayed using, for example, a user interface of a catheter programming system (e.g., Figure 1 In another embodiment, one or more additional constraint points along the path may also be identified. Figure 6 In the embodiment of the present invention, a source point 610, a target point 612, and a constraint point 614 are identified on a vascular image 608. Additional constraint points (e.g., Figure 1 User interface 126 shown).

[0032] return Figure 5, at box 508, determine the path between the source point and the target point through the vessel. In an embodiment, the path is determined by calculating the shortest path between the source point and the target point through the vessel. For example, a directed weighted graph can be generated from the skeleton of the vessel image. The shortest path on the directed graph can then be calculated from the source point to the target point (e.g., based on weights and / or cost functions). In addition, the length (or distance) of the identified path through the vessel from the source point to the target point can be determined. If additional constraint points have been provided, the shortest path between each pair of consecutive points can be calculated. All calculated paths can then be accumulated into a single path on the directed graph from the source point to the target point through all constraint points. At box 506, the constraint points can be identified by the operator using the source point and the target point, or if the path is not correctly identified, the user or operator can provide the constraint points. For example, a display (e.g., Figure 1 The identified path is displayed to the user (e.g., in a 2D or 3D image) using a display 120, 122 as shown, and the user can approve the path using input from the user interface, or can use the user interface to provide one or more additional constraint points. The process of block 508 is then repeated with the additional constraint points. In another embodiment, the path can be smoothed or corrected based on the bending energy of the guidewire or other elongated medical device. For example, a directed graph can be generated that connects a set of sample points of the vessel traversed along the path. The graph weight can be set to the estimated local bending energy of the guidewire or other elongated medical device, which is related to the local bending angle between each two vectors. The path can then be calculated by determining the shortest path that minimizes the local bending energy from the source point to the target point. An example of a method based on curved energy smoothing paths is described in S. Schafer, V. Singh, PB Noel, AMWalczak, J. Xu and KRHoffmann, “Real-time endovascular guidewire position simulation using shortest path algorithms”, Int J. CARS 4, pp. 597-608 (2009), which is incorporated herein by reference in its entirety.

[0033] In another embodiment, a three-dimensional path may be generated. The three-dimensional path may be generated using two different views from the set of images, for example, a first image at a first view and a second image at a second view. A first two-dimensional vascular image may be created using the first image at the first view, and a second two-dimensional vascular image may be created using the second image at the second view. In an embodiment, the first two-dimensional vascular image and the second two-dimensional vascular image may be generated as described above with reference to step 504. As described above with reference to steps 506 and 508, a path through the vessel of interest between a source point and a target point is determined for the first vascular image, and a path is determined for the second vascular image. Fig.11 The first and second two-dimensional views of a path and the generated three-dimensional path according to an embodiment are illustrated. A three-dimensional path 1106 can then be generated using the path 1102 of the first two-dimensional vascular image at the first view and the path 1104 of the second two-dimensional vascular image at the second view. In one embodiment, the three-dimensional path is generated by first projecting the first 2D vascular image 1108 onto 3D space and projecting the second 2D vascular image 1110 onto 3D space based on a set of parameters of the imaging system (e.g., parameters of a C-arm). Next, for each point in a set of points on the path in the first vascular image, a set of epipolar lines is calculated on the second vascular image, and the most likely matching point on the other path is determined using, for example, a Viterbi algorithm. For every two matching points in the two views, a common point is found in 3D space, thereby reconstructing the three-dimensional path.

[0034] If the vessels traversed by the path are located in an area of ​​the vasculature that is not affected by movement due to the physiological cycle, then the path is independent of the phase of the physiological cycle. In another embodiment, the path is determined for a single phase of the cardiac cycle or other physiological cycle. In another embodiment, the path is determined for all phases of the cardiac cycle or other physiological cycle. In embodiments where the vessels are affected by the cardiac cycle, the start point of the cardiac cycle can be selected, for example, using R-phase gating and acquiring images synchronized with the peak of the R wave. If image data for less than all phases of the heart is acquired at box 502, data can be interpolated from the acquired image data and used to identify the path for all phases of the cardiac cycle. In an embodiment, to determine the path for all phases of the heart, the path can be tracked between adjacent frames using, for example, matching points or a Viterbi algorithm. A control system or controller (e.g., Figure 2 The controller 134 shown may be configured to determine a path from a source point to a destination point as described above.

[0035] In an embodiment, determining the path from the source point to the target point through the vessel at box 508 also includes identifying a sub-vessel or branch of the path vessel, wherein the sub-vessel or branch is not part of the identification path between the source point and the target point, but is connected to the vessel in the identification path via a bifurcation. Therefore, the sub-vessel or branch represents an incorrect or wrong path. The sub-vessel or branch can be identified or detected based on the contrast-enhanced image data collected at step 502. In addition, the sub-vessel or branch can be distinguished from the cross-vessel, which appears to overlap with the path vessel, or appears to be overlapped by the path vessel, but is not directly connected to the path vessel. In one embodiment, the sub-vessel or branch can be identified based on the appearance of the contrast agent in the collected image. For example, the sub-vessel or branch is filled with contrast after the main path vessel, and the cross-vessel is filled with contrast before the main path vessel. If the branch is a sub-vessel in direct fluid communication with the vessel, the contrast in the sub-vessel will be considered to appear immediately after the contrast is observed in the portion of the vessel in fluid communication with it. In one embodiment, contrast that appears earlier or later in a branch at a predetermined time will be identified as a non-connected crossing branch. Two-dimensional reconstruction or three-dimensional reconstruction can be used to reconstruct one or more images including the identified path from the source point to the target point and any identified daughter vessels. Fig. 12A , an image of a vascular system 1200 includes vessels extending from a source 1212 to a target 1214. In one embodiment, vessel 1202 is in a path extending from source 1212 to target 1214. Although it is possible that the path extending from source 1212 to target 1214 includes many vessels. Sub-vessels 1204 are in direct fluid communication with vessels identified in the path between the source and the target. Branches 1206 that appear in the 2D image intersect or are below the path vessels, but are not in direct fluid communication, and these branches are referred to as non-connected branches. As discussed above, sub-vessels 1204 and non-connected branches 1206 are identified using the outlined process or other methods known in the art. Reference Fig. 12B Once sub-vessel 1204 and branch 1206 are identified, vessel mask 1208 is applied and displayed on the image associated with the path mask. Sub-vessel mask 1210 is applied and displayed on the image associated with the path mask. In one embodiment, sub-vessel mask only covers the portion of sub-vessel 1204 that is immediately adjacent to vessel 1202. Vessel mask 1208 is applied and displayed from source point 1212 to target point 1214, as shown in FIG. Fig. 12A One or more images may be used as reference images and displayed on a display (e.g., Figure 1 The catheter procedure system may be displayed to a user of the catheter procedure system by a control system or controller (e.g., Figure 2The controller 134 shown may be configured to identify sub-vessels or non-connected branches and generate an image with the identified pathways and sub-vessels as described above.

[0036] return Figure 4 Once a path through the vessel from the source point to the target point is identified, a map or mask of the identified path is created at box 404. In an embodiment, the mask is applied as a semi-transparent cover that allows a user or operator to visualize or allows the system to track a device that is navigated along the path or deviates from the path in the vessel. Applying the mask to the image eliminates the need for contrast because the path can be visualized. In one embodiment, the mask is displayed by highlighting the path. In this way, the path is displayed in a prominent manner on the display. In addition, masks of the identified sub-vessels or branches, referred to herein as sub-vessel masks, can also be created. If the vessel is affected by a physiological cycle such as the cardiac cycle, in one embodiment, a mask can be created for a single stage of the cardiac cycle or other physiological cycle. In another embodiment, a mask can be created for each stage of the cardiac cycle or other physiological cycle. In one embodiment, the masks of the paths and sub-vessels can be two-dimensional. In one embodiment, a vessel mask of the path (and / or sub-vessels) can be created around the identified path using, for example, a minimum cost contour detection algorithm (MCA) to locate and smooth the edges of the vessel. Vessel curvature can be determined by mapping pixels to a "vertical" image based on local path curvature properties. After finding and smoothing the edges, the path centerline can be corrected to the centroid of each pair of edge points. Other mask boundaries can be estimated by connecting the edges of the mask in a direction perpendicular to the vessel direction. The areas inside these lines can be colored and the morphological openings identified. Figure 7 Exemplary pathway covers and subvessel covers according to embodiments are illustrated. Figure 7, a path mask 702 is shown having a first cross-hatching overlaid on a path identified in an image (e.g., a reference image or a real-time image). The reference image or real-time image can be two-dimensional or three-dimensional. A plurality of sub-vessel masks 704 are shown, with a second cross-hatching overlaid on a plurality of identified sub-vessels or branches in the image. In one embodiment, different colors may be used to indicate the path mask 702 and the sub-vessel masks 704 on the image. In an embodiment, the vessel mask 704 covers only the portion of the sub-vessel immediately adjacent to the path 702. In one embodiment, the vessel mask 704 covers a majority of the sub-vessel. As described above, since masks may be created for the path and sub-vessels for each phase of the cardiac cycle, the masks for the path and sub-vessels may change appropriately over time, such as through the cardiac cycle. Thus, appropriate masks may be displayed during all phases of the cardiac cycle (e.g., by overlaying the mask on a reference image or a real-time image). A control system or controller (e.g., Figure 2 The controller 134 shown may be configured to create a mask of the identified pathways and sub-vessels as described above.

[0037] At block 406, the pathway mask and subvessel mask may be displayed to an operator of the catheter procedure system (e.g., in Figure 1 122 as shown). For example, the path mask and sub-vessel mask can be used to assist an operator in manually navigating an elongated medical device, to assist an operator in navigating an elongated medical device using a catheter procedure system, or to allow an operator to monitor navigation if navigation is fully automated using a catheter procedure system. If navigation is fully automated, then as described below, at box 406 or during navigation, the path mask and sub-vessel mask need not be displayed to the operator. As described above, the path mask and sub-vessel or branch masks can be overlaid on a reference image, where the mask corresponds to the stage of the reference image, or the path mask and sub-vessel mask can be overlaid on a real-time image without contrast, where the mask corresponds to the cardiac stage of a particular real-time image. Thus, during each stage of the cardiac cycle, the path mask and sub-vessel mask can be appropriately changed with any changes in the identified path and sub-vessels.

[0038] At block 408, the elongated medical device is navigated along the identified path using the catheter procedure system. In one embodiment, the elongated medical device is navigated in a fully automated manner using the catheter procedure system. In another embodiment, an operator can view an overlay of the identified path and subvessel and device tracking information described further below to assist the operator in navigating along the path and delivering the elongated medical device to a target location using the catheter procedure system. Figure 8A method for delivering an elongated medical device to a target location according to an embodiment is illustrated. At box 802, movement of the device is initiated, for example, an operator can provide input via a user interface to begin a fully automated process, or an operator can utilize a user interface to control movement of the device. The following description will relate to navigation of an exemplary guidewire, however, it should be understood that the techniques described herein can also be used for navigation of other elongated medical devices, such as, for example, a working catheter (e.g., a balloon catheter or stent delivery system), a microcatheter, or a lesion treatment device. A control system or controller (e.g., Figure 2 The controller 134 shown in the figure can be configured to perform some or all portions of the method of delivering an elongated medical device to a target location as described below. As the guidewire is moving, the position of the guidewire is tracked at box 804. In one embodiment, an imaging system can be used to track the distal portion of the guidewire. In one embodiment, the distal portion of the guidewire includes the tip of the guidewire. The distal portion of the guidewire can be radiopaque, and the position of the distal portion of the guidewire can be tracked using images acquired during navigation using the imaging system (e.g., Figure 1 1. In one embodiment, the image is a fluorescence image taken without contrast.

[0039] When guide wire moves through path vessel and the distal part of guide wire is tracked, determine and update the remaining path length based on the position of guide wire distal part.As used herein, remaining path length is the distance between the distal part and the target point or position of guide wire (or other elongated medical devices) passing the path of identification when the distal part is on the path of identification.Along with the distal part of guide wire advancing towards the target point from the source point by the path of identification, the remaining path length reduces.In an embodiment, except guide wire, this program may need to use microcatheter.In such an embodiment, guide wire and microcatheter can advance through the path from the source point to the target point in an alternating stepping manner.The position of guide wire distal part can be projected or displayed on the image including path and sub-vascular covering. Fig. 9 An exemplary display is shown that illustrates a path and tracks a guidewire passing through the path, according to an embodiment. Fig. 9 As shown, the display includes a first view 902 and a second view 904. The display may be on a display of a catheter procedure system (e.g., Figure 1120, 122) to an operator of the catheter procedure system. A first view 902 shows a reference image of the path as shown by the dashed line and a mask 908, with potential branches along the path shown with "X". A second view 904 shows a real-time image showing the movement and position of a distal portion 910 of the guidewire as it moves through the path. In an alternative embodiment, the display may include a view showing a real-time image with both the mask (path and sub-vessels) and the guidewire tracking. Although Fig. 9 900 is not shown, but the subvessel cover may also be shown in the display. The display 900 also shows the remaining path length 906. The remaining path length is calculated in pixels, although other metrics may be used in other embodiments. As the guidewire moves along the path toward the target point, the remaining path length 906 will be shown as decreasing toward zero. Ultimately, a portion 909 of the guidewire may be indicated by showing its progress along the cover 908 of the path.

[0040] At box 806, at least based on the remaining path length, determine whether the distal portion of the guide wire deviates from the path. If the remaining path length is decreasing and is greater than but not equal to zero, the guide wire continues to advance. In an embodiment, the speed of the guide wire when it moves is determined based on the remaining path length using a control law. The control law can be a negative feedback control law, and can be selected to make the resulting system stable (e.g., Lyapunov stable). The relationship between the command speed and the negative value of the remaining path length is a passive relationship. Therefore, the appropriate feedback control law based on the negative value of the remaining path length is also passive (for the linear time-invariant case, it is also a positive real number). The passive control law is a control law that satisfies the integral of the input and output product to be positive. Therefore, for the control law based on the negative remaining path length, the input is the negative remaining path length, and the output is the negative speed. In an example control law, the speed can be proportional to the remaining path length, that is, as the remaining path length decreases, the speed of the device decreases. In other examples, the speed can be proportional to the remaining path length with a saturation limit (e.g., based on the limit of the maximum allowable speed of a guidewire or other device), the speed can be scaled by a continuous smooth function (such as a hyperbolic tangent function), the speed can be scaled by a cubic mapping, or the speed can be scaled by a cubic mapping with a saturation limit. In "On relationships among passivity, positive realness, and dissipativity in linear systems" by Kottenstette, Nicholas et al., Automatica 50.4 (2014): 1003-1016, an example of a method for controlling a positive real (or passive) system is described, the entire contents of which are incorporated herein by reference. In another embodiment, the speed of the guidewire can also be adjusted based on the local properties of the path (such as tortuosity or narrowing).

[0041] At box 806, various parameters can be used to determine whether the guidewire has deviated from the path. In an embodiment, if the remaining path length is less than zero (a negative number), the device has deviated from the path. For example, if the device is moving along a subvessel or branch that is not part of the identified path to the target point, or if it has passed the target point, the device may have deviated from the path. If the guidewire deviates from the identified path, the remaining path length changes from a positive number to a negative number, which increases in a negative direction to indicate the distance the distal portion of the guidewire has traveled along a branch vessel that is not on the path. If the guidewire passes through the target point, the remaining path length will change from a positive number to a negative number, and the remaining path length will increase in a negative direction to indicate the distance the distal portion of the guidewire has moved past the target point. The change in the remaining path length from a positive number to a negative number can be displayed to the operator, for example, in Fig. 9, display 900 may display remaining path length 906 as a negative number.

[0042] At box 807, if the remaining path length has not decreased, it can indicate that the distal portion of the guidewire has stopped moving and corrective action is required. For example, if the proximal end of the guidewire is being delivered into the patient's body by the catheter programming system, but the distal portion of the guidewire has not moved, corrective action may be required to change the position of the distal portion of the guidewire. If the guidewire deviates from the path at box 806, or if the remaining path length has not decreased at box 807, the catheter programming system generates an alarm at box 814. The alarm can be displayed on a display (e.g., Figure 1 The alarm may be displayed to the operator of the catheter procedure system on a display 120, 122 as shown and / or may be audible. In another embodiment, the procedure may be stopped and an alarm may be displayed to the operator so that the operator may take corrective action. In another embodiment, the catheter procedure system may automatically take corrective action.

[0043] At frame 816, the position of the guidewire or the distal portion of the guidewire is corrected. In one embodiment, when the remaining path length is converted to a negative number, the speed of the guidewire is converted to a negative number proportional to the remaining path length, so the distal portion of the guidewire can be retracted. For example, the guidewire can be retracted until the distal position of the guidewire is positioned back on the path of the junction before the branch, or retracted back to the target point. In another example, the guidewire can be rotated and retracted until the distal portion of the guidewire is positioned back on the junction on the path before the branch or retracted to the target point. Another example of a corrective action is to adjust the position of the distal end of the guide catheter to redirect the guidewire along the correct path. The distal portion of the guidewire can also "swing" to pass through the upcoming branch of the deviation path. In one embodiment, the catheter program system automatically performs a corrective action to reposition the distal portion of the guidewire. In another embodiment, the operator controls the guidewire to adjust the position of the distal portion of the guidewire by providing an input command using the user interface of the catheter program system. In one embodiment, the operator can repeat the corrective action, or the catheter program system automatically performs the corrective action until the position of the guidewire is corrected. For example, if the first retraction of guide wire does not place the distal portion of guide wire on the path, then guide wire can be retracted again. In an embodiment, different types of correction actions can be taken in succession, until the position of the distal portion of guide wire is on the path. For example, guide wire can be retracted at first, and can be rotated and retracted then. Once the position of guide wire distal portion is corrected at frame 816 places, guide wire just restarts along the advancement of path, and the process continues at frame 804 places, with the movement of tracking device by path.

[0044] Returning to box 806, if the guidewire is on the path, movement of the guidewire along the path continues. At box 807, if the remaining path length is decreasing, movement of the guidewire along the path continues. A guidewire or other elongated medical device may experience prolapse when being advanced through the vascular system. At box 808, if prolapse of the distal portion of the guidewire is detected, an alarm is generated at box 818. The alarm may be displayed on a display (e.g., Figure 1 The alarm may be displayed to the operator of the catheter procedure system on the display 120, 122 shown and / or the alarm may be audible. In an embodiment, prolapse may be detected by inspecting the distal portion of the guidewire using an imaging system. Fig.10 Exemplary types of wire prolapse according to embodiments are illustrated. Fig.10 , an open prolapse 1002 and a closed complete loop prolapse 1006 are shown. An open prolapse 1002 is a condition where the distal portion 1004 of the guidewire is bent but does not have a complete loop. In one embodiment, an open prolapse 1002 can be detected by checking the curvature of the distal portion 1004 of the guidewire. A closed prolapse 1006 is a condition where the distal portion 1008 of the guidewire has a complete loop. In an embodiment, a closed loop prolapse 1006 is detected using morphological filling. An image of the distal portion 1006 is subtracted from the "filled" image to check for loop holes. In another embodiment, information from a previous image can be used to detect prolapse, for example, to detect whether the distal portion of the guidewire is transitioning to prolapse. At box 820, the detected prolapse can be corrected. At box 820, the catheter program system can be configured to provide the operator with a suggested technique on how to correct the prolapse. For example, various navigation techniques such as "knuckling" techniques can be used to correct prolapse, stop and back off devices, stop and rotate devices, or rotate and retract devices. In one embodiment, the catheter program system automatically performs a corrective action to correct the prolapse of the distal portion of the guide wire. In another embodiment, the operator controls the guide wire by providing an input command using the user interface of the catheter program system. In one embodiment, the corrective action can be repeated by the operator, or automatically performed by the catheter program system until the prolapse is corrected. For example, if the first retraction of the guide wire does not correct the prolapse, the guide wire can be retracted again. In an embodiment, different types of corrective actions can be taken in succession until the prolapse is corrected. For example, the guide wire can be stopped and backed up first, and then the knuckling technique can be used. Once the prolapse of the distal portion of the guide wire is corrected at frame 820, the advancement of the guide wire along the path is restarted, and the process continues at frame 804 to track the movement of the device through the path. At frame 810, if the remaining path length is equal to zero, the distal portion of the guide wire has reached the target position or point. Movement of the guidewire stops and navigation ends at box 812.

[0045] return Figure 4At block 410, if the target location is reached, for example, the remaining path length is equal to zero, then the navigation of the device is terminated at block 412. If the target has not been reached at block 410, the navigation process continues at block 408.

[0046] Computer executable instructions for navigating a device through a path to a target location and generating a path cover to the target location according to the above method can be stored in the form of a computer readable medium. Computer readable media include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information such as computer readable instructions, data structures, program modules or other data. Computer readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other storage technology, compact disk ROM (CD-ROM), digital versatile disk (DVD) or other optical storage, cassettes, magnetic tape, disk storage or other magnetic storage devices, or media (such as) that can be used to store the desired instructions and can be accessed by the system 10 (including through the Internet or other computer network access form). Figure 1 any other medium as shown).

[0047] This written description uses examples to disclose the invention, including the best mode, and also to enable those skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements that do not differ substantially from the literal language of the claims. The order and sequence of any process or method steps may be changed or reordered according to alternative embodiments.

[0048] Numerous other changes and modifications may be made to the present invention without departing from the spirit of the invention. The scope of these and other variations will become apparent from the appended claims.

Claims

1. A system for delivering an elongated medical device along a path to a target location, the system comprising: A bedside system comprising a drive assembly configured to drive an elongated medical device; as well as a controller coupled to the bedside system, wherein the controller is programmed to: generating a mask for the well-defined path, the mask being applied to an image of an imaging system; tracking a position of a distal portion of the elongated medical device based on a set of real-time images acquired by the imaging system; determining a remaining path length based at least on a position of a distal portion of the elongated medical device, The remaining path length is the distance between the distal portion of the elongated medical device and the target location, wherein the remaining path length decreases as the distal portion of the elongated medical device approaches the target location; updating the remaining path length during movement of the elongated medical device; determining whether the distal portion of the elongated medical device has deviated from a path; If a result of the determining indicates that the distal portion of the elongated medical device is off-path, driving the elongated medical device with the drive assembly in a corrective action; and The elongate medical device is driven using the drive assembly at a speed determined based at least on the remaining path length.

2. The system according to claim 1, wherein: The controller is also programmed to adjust the speed based on the remaining path length, the speed being proportional to the remaining path length. The system according to claim 1 , further comprising a user interface.

4. The system of claim 1, further comprising a workstation coupled to the bedside system, wherein: The workstation also includes a display, and wherein the controller is further programmed to display the covering over an image associated with the covering on the display.

5. The system according to claim 1, wherein: The controller is also programmed to determine whether at least one daughter vessel is connected to the pathway.

6. The system according to claim 1, wherein: The controller is also programmed to display the covering and the sub-vessel covering over an image associated with the covering on a display.

7. The system according to claim 1, wherein: The speed is proportional to the remaining path length.

8. The system according to claim 1, wherein: The controller is also programmed to generate a covering for each phase of the menstrual cycle.

9. The system according to claim 8, wherein: The workstation also includes a display, and wherein the controller is further programmed to display each covering on an image on the display corresponding to the phase of the heart cycle associated with the covering.

10. The system according to claim 1, wherein: The controller is also programmed to determine whether the distal portion of the elongated medical device has deviated from a path based on the remaining path length.

11. The system according to claim 10, wherein: The controller is further programmed to adjust the position of the distal portion of the elongate medical device in response to the remaining path length being a negative number.

12. The system of claim 1, wherein: The position of the distal portion of the elongate medical device is adjusted by retracting the elongate medical device using the drive assembly.

13. The system of claim 1, wherein: The position of the distal portion of the elongate medical device is adjusted by rotating and retracting the elongate medical device using the drive assembly.

14. The system of claim 1, wherein: The elongated medical device is a guidewire.

15. The system of claim 14, wherein: The tip of the guidewire is radiopaque.

16. The system of claim 4, wherein: The image on which the mask is displayed is a fixed reference image of the region of interest.

17. The system of claim 4, wherein: The image on which the cover is displayed is a real-time image of the region of interest.

18. The system of claim 1, wherein: The imaging system is a fluoroscopy system.

19. The system according to claim 18, wherein: The set of real-time images are fluorescent images.

20. The system of claim 1, wherein: The controller is also programmed to adjust the position of the distal portion of the elongate medical device in response to detecting a prolapse.

21. The system of claim 1, wherein: The workstation includes a display, and wherein the controller is programmed to generate coverings for a set of branches connected to the path and to display each covering of the set of branches on an image associated with the covering on the display.

22. The system of claim 21, wherein: The controller is programmed to generate a set of branched masks including generating a mask for each phase of the physiological cycle.

23. The system of claim 11, wherein: As the distal portion of the elongated medical device advances into a branch, the remaining path length turns negative.

24. The system of claim 11, wherein: As the distal portion of the elongated medical device advances past the target location, the remaining path length turns negative.

25. The system of claim 1, wherein: When the distal portion of the elongated medical device reaches the target location, the remaining path length is equal to zero.

26. The system of claim 10, wherein: The controller is further programmed to generate an alarm in response to the remaining path length being a negative number.

27. A non-transitory computer readable medium storing computer executable instructions that, when executed by at least one processor at a workstation, cause the workstation to perform a method for generating a mask of a calculated path to a target location and tracking a position of an elongated medical device moving along the calculated path, the method comprising: generating a vascular image based on at least one image from a set of medical images of the region of interest; identifying a source point and a target point on the vascular image; calculating a vascular path from the source point to the target point based at least on the set of medical images; generating a pathway mask for the vascular pathway; determining whether at least one sub-vessel is connected to the vascular path based on at least contrast agent flow in the set of medical images; generating a sub-vessel cover for the at least one sub-vessel; as well as The pathway mask and the sub-vessel masks are displayed on an image associated with the pathway mask.

28. A system for generating a mask of a calculated path to a target location and tracking the position of an elongated medical device moving along the path, the system comprising: a controller configured to be coupled to a user interface, at least one display, and an imaging system, the controller being programmed to: receiving a set of contrast-enhanced images of a region of interest from the imaging system; generating a vascular image based on at least one image from the set of contrast-enhanced images; receiving identification of a source point and a target point on the vascular image; calculating a vascular path from the source point to the target point based at least on the set of contrast-enhanced images; determining whether at least one sub-vessel is connected to the vascular path based at least on contrast agent flow in the set of contrast enhanced images; generating a pathway mask for the vascular pathway; If at least one sub-vessel is connected to the vascular path, generating a sub-vessel cover for the at least one sub-vessel; The pathway mask is displayed on an image associated with the pathway mask on the display, and if at least one sub-vessel is connected to the vascular pathway, the sub-vessel mask of the at least one sub-vessel is displayed on the image associated with the pathway mask on the display.

29. A computer program product comprising computer executable instructions which, when executed by at least one processor at a workstation, cause the workstation to perform a method for generating a mask of a calculated path to a target location and tracking a position of an elongated medical device moving along the calculated path, the method comprising: generating a vascular image based on at least one image from a set of medical images of the region of interest; identifying a source point and a target point on the vascular image; calculating a vascular path from the source point to the target point based at least on the set of medical images; generating a pathway mask for the vascular pathway; determining whether at least one sub-vessel is connected to the vascular path based on at least contrast agent flow in the set of medical images; generating a sub-vessel cover for the at least one sub-vessel; as well as The pathway mask and the sub-vessel masks are displayed on an image associated with the pathway mask.

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