Navigation operation command

Abstract

The device for intrabody navigation operation instructions includes a position data provider, an anatomical data provider, a processor, and an output unit. The position data provider provides current position data of a tool portion having a tool tip inserted into an anatomical structure within a region of interest. The anatomical data provider provides 3D information of the anatomical structure and provides target information for movement of the tool tip within the anatomical structure. The processor determines a current position of the tool tip within the anatomical structure based on the current position data, determines at least one of a movement specification and trajectory information based on the target information and the determined current position to align movement of the tool tip with the target information, and determines an operation command for a user to achieve movement of the tool tip according to at least one of the movement specification and trajectory information based on the at least one of the movement specification and the trajectory information. The output unit provides the operation command to the user.

Description

Technical Field

[0001] The present invention relates to providing navigation operation instructions, for example, during catheter procedures. The present invention particularly relates to an apparatus for in-vivo navigation operation instructions, a catheter system, and a method for providing in-vivo navigation operation instructions.

Background Art

[0002] The catheter method is a medical procedure used to examine, diagnose, and treat a specific patient's condition in a minimally invasive manner. To access the area of interest, a catheter, which is a thin hollow tube made of medical-grade material with a diameter smaller than the blood vessel / artery of interest, is inserted into the patient's arm (radial artery), leg (femoral artery / vein), groin (upper thigh), or neck (internal jugular vein) and passed through the blood vessel / artery to the patient's area of interest. Each blood vessel has its advantages and disadvantages. By using a catheter, a doctor can perform diagnostic tests and treatments on the patient's area of interest. Catheters have a number of shapes, lengths, diameters, and other special features such as electrodes and balloons. Once placed in a fixed position, they are used, for example, to perform measurements or interventions. For example, in the case of cardiac catheterization, the catheter is guided into the patient's heart. As an example, the term catheterization refers to cardiac catheterization (also known as heart cath).

[0003] As an example, catheter procedures can be performed in a special examination room with fluoroscopy and a highly maneuverable patient table. These "cath rooms" can have cabinets for various sizes of catheters, stents, balloons, etc. to enhance the operating efficiency during the intervention.

[0004] Visualization has been shown to be a crucial aspect of catheterization, as physicians must be able to see the occlusion within the artery. This generally includes fluoroscopy, but can also include forms of echocardiography (TTE, TEE, ICE) or ultrasound (IVUS). For example, ultrasound uses sound waves to create detailed images of the heart's blood vessels. In-lab monitors may show the catheter within anatomical structures, such as live fluoroscopy images, ECG, and pressure waves, as the procedure progresses.

[0005] Because individual anatomy differs and is complex, navigating through blood vessels to access the heart is a challenge during procedures. For example, International Publication 2014 / 100530(A1) concerns catheter steering. In some cases, surgeons use X-ray images taken with contrast fluid to locate blood vessels while feeding the catheter. Thus, surgeons monitor the catheter's position on a monitor by taking X-ray images when necessary and guide the catheter through the blood vessels by maneuvering the tip through the junction or through the anatomical structures of the heart. Translational movement is achieved by pushing the catheter. Tip manipulation is performed via clock (roll), yaw, and pitch movements to rotate the tip to maneuver through the junction or through the anatomical structures of the heart. For example, by rotating the catheter clockwise or counterclockwise, the tip of the catheter changes direction. However, the lack of 3D information makes the procedure difficult in that it is more susceptible to damage and therefore more time-consuming, due to the extra effort surgeons must expend to mitigate its risks. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] Therefore, it may be necessary to provide improved navigation instructions. [Means for solving the problem]

[0007] The object of the present invention is solved by the subject matter of the independent claims, and further embodiments are incorporated into the dependent claims. It should be noted that the embodiments of the present invention described below also apply to devices for in-vivo navigation action commands, catheter systems, and methods for providing in-vivo navigation action commands.

[0008] The present invention provides a device for in-vivo navigation operation commands. The device comprises a position data supply unit, an anatomical data supply unit, a processor, and an output unit. The position data supply unit is configured to provide current position data of a tool portion having a tool tip inserted into an anatomical structure within a region of interest of a target. The anatomical data supply unit is configured to provide 3D information of the anatomical structure. The anatomical data supply unit is also configured to provide target information for the movement of the tool tip within the anatomical structure. The processor is configured to determine the current position of the tool tip within the anatomical structure based on the current position data. The processor is also configured to determine at least one of a group of movement specifications and trajectory information based on the target information and the determined current position in order to align the movement of the tool tip with the target information. The processor is further configured to determine an operation command for the user to achieve the movement of the tool tip according to at least one of the group of movement specifications and trajectory information based on at least one of the group of movement specifications and trajectory information. The output unit is configured to provide the operation command to the user.

[0009] This provides a significant advantage to surgeons in maneuvering the device themselves, providing crucial guidance on what specific movements should be made precisely next to avoid junctions—that is, how much and in which direction to control movement for efficient rotation, where to move faster, and where to slow down more effectively. In other words, it provides invaluable operational guidance on navigating the catheter in 3D through vascular structures. This facilitates the non-trivial and dangerous task of route finding and maneuvering to the desired region of interest, especially in complex and microvascular structures such as those within the lungs.

[0010] An action command is an instruction required by the user for the proper handling of a manual interface, such as a handle or tool grip, to achieve a desired movement along a target path or toward a determined target position. An action command is an input action or actuation by the user, resulting in proper navigation. Therefore, an action command is distinct from navigation information or navigation commands. Navigation commands relate to commands related to the movement of an actual inserted intervention device, such as a catheter, while action commands relate to commands related to the operation (i.e., action) of the operating interface for the movement and actuation of the intervention device. As an example, the processor is configured to determine a movement specification based on target information and the determined current position in order to align the movement of the tool tip with the target information. The processor is further configured to determine an action command to the user to achieve the movement of the tool tip in accordance with the movement specification, based on the movement specification.

[0011] As another example, the processor is also configured to determine trajectory information based on target information and the determined current position in order to align the movement of the tool tip with the target information. Based on the trajectory information, the processor is further configured to determine an action command to the user to achieve the movement of the tool tip according to the trajectory information. In one example, the tool is a catheter, and the tool tip is the catheter tip. The anatomical structure is a vascular structure.

[0012] In one example, data representing a graphical representation of at least an anatomical structure in the region of interest is provided, and the processor is configured to generate image data showing the tool tip at its current position within the context of the anatomical structure.

[0013] Optionally, the output is a display configured to show image data of the tool tip and anatomical structures in combination with the operation commands.

[0014] In one example, the operation command contains instructions to the user for manipulating the control handle of a tool, the tool having a tool tip attached, and the tool tip being configured to be manipulated within the anatomical structure of the region of interest.

[0015] Optionally, the motion commands are provided as operational instructions for the user on how to operate multiple motion control units of the tool's control handle, with the motion control units relating to the direction of tip movement, tip bending, and tip movement vector.

[0016] As a result, the operational commands are interpreted according to the view provided to the user.

[0017] In one example, multiple motion control units are provided with graphic indicators that are visible to at least the user of the handle. The motion commands are associated with the graphic indicators. For visual differentiation, the graphic indicators may have at least one of the groups of color, pattern, and shape.

[0018] This provides an intuitive method for the user, as operation commands can be applied directly without requiring the transfer of output to the respective spatial arrangements of control handles.

[0019] In one example, a control handle interface is further provided, configured to receive handle information relating to the operation control of a control handle and to provide it to the processor. The processor is further configured to determine an operation instruction based on the handle information.

[0020] In one example, the control handle interface is configured to receive handle position data having at least one of the following groups: orientation in space (clocking rotation), position relative to the object, and distance between the control handle and the catheter tip. The processor is further configured to determine an action command based on at least one of the following groups: orientation in space, position relative to the object, and distance between the control handle and the catheter tip.

[0021] As an example, the catheter is configured to be fed through a control handle. As another example, the control handle is configured to be fixed to the end of the catheter. Depending on how far the catheter is inserted into the body, the catheter is subjected to more or less friction from anatomical structures, and therefore the catheter tip may not respond very directly to the clocking of the control handle. This can also be true when bending the catheter tip in relation to the control input. In one example, the operational command for how much clocking or bending should be applied to the control handle is adjusted accordingly, taking these position-dependent deviations into account.

[0022] In one example, the action commands are provided as augmented reality by overlaying the commands onto a physical control handle via a head-mounted display. Alternatively, the action commands are overlaid onto a virtual representation of the handle shown on a fixed display.

[0023] Optionally, navigation information is provided in addition to the operation instructions, and the operation instructions are separated from the navigation information.

[0024] According to the present invention, a catheter system is also provided. The system has a catheter having a control handle, a catheter body, and a catheter tip. The system has a device for in vivo navigation operation instructions according to one of the aforementioned examples. The catheter tip is attached to one end of the catheter body, and the catheter control handle is connected to the catheter body towards the other end of the catheter body. The operation instructions have instructions for the user to handle the control handle in order to operate the catheter tip when inserted into the vascular structure of the target region of interest.

[0025] According to the present invention, a method for providing in vivo navigation operation instructions is also provided. The method includes - providing current position data of an anatomical part using a tool tip inserted into an anatomical structure within a target region of interest; - providing 3D information of the anatomical structure; - providing target information for movement of the anatomical structure tip within the anatomical structure; - determining the current position of the anatomical structure tip within the anatomical structure based on the current position data; - determining at least one of a group of movement specifications and trajectory information based on the target information and the determined current position to align the movement of the anatomical structure tip with the target information; - determining operation instructions for the user to achieve movement of the anatomical structure tip according to at least one of the group of movement specifications and trajectory information based on at least one of the group of movement specifications and trajectory information; - providing the operation instructions to the user; and includes.

[0026] According to one aspect, in order to navigate a tool that is at least partially inserted inside an object, a user is provided with operation instructions that bring about a desired navigation result. Thus, the operation instructions have operation instructions for the user in a way that is adapted to the user's operation situation, for example, the handle used by the user, so as to facilitate navigation.

[0027] These and other aspects of the invention will become apparent from the embodiments described below and will be explained with reference to them.

[0028] Exemplary embodiments of the invention will be described below with reference to the following drawings.

Brief Description of the Drawings

[0029] [Figure 1] Schematically shows an example of an apparatus for in-body navigation operation instructions. [Figure 2] Shows the basic method steps of an example of a method for providing in-body navigation operation instructions. [Figure 3a] Shows an example of in-body navigation operation instructions presented to a user. [Figure 3b] Shows an example of in-body navigation operation instructions presented to a user. [Figure 4] Shows an example of a catheter system. [Figure 5] Shows a further example of a workflow related to providing in-body navigation operation instructions.

Modes for Carrying Out the Invention

[0030] Here, specific embodiments are described in detail with reference to the accompanying drawings. In the following description, similar drawing reference numbers are used for similar elements even in different drawings. Matters specified herein, such as detailed configurations and elements, are provided to aid in a comprehensive understanding of exemplary embodiments. Also, well-known functions or configurations are not described in detail, as this would obscure the embodiments with unnecessary details. Furthermore, expressions such as "at least one of" qualify the entire list of elements when preceding a list of elements, and do not qualify the individual elements of the list.

[0031] Figure 1 schematically shows an example of a device 10 for in-vivo navigation operation commands. The device includes a position data supply unit 12, an anatomical data supply unit 14, a processor 16, and an output unit 18.

[0032] The position data supply unit 12 is configured to provide current position data of a tool portion having a tool tip inserted into an anatomical structure within a region of interest. The anatomical data supply unit 14 is configured to provide 3D information of the anatomical structure. The anatomical data supply unit 14 is also configured to provide target information for the movement of the tool tip within the anatomical structure. The processor 16 is configured to determine the current position of the tool tip within the anatomical structure based on the current position data. The processor 16 is also configured to determine at least one of a group of movement specifications and trajectory information based on the target information and the determined current position in order to align the movement of the tool tip with the target information. The processor 16 is further configured to determine an action command to the user to achieve the movement of the tool tip according to at least one of the group of movement specifications and trajectory information based on at least one of the group of movement specifications and trajectory information. The output unit 18 is configured to provide the action command to the user.

[0033] In Figure 1, the frame 20 shows that, as an option, the position data supply unit 12, the anatomical data supply unit 14, and the processor 16 are provided in a common arrangement, for example, within a common housing or device. In another option, some or each of the position data supply unit 12, the anatomical data supply unit 14, and the processor 16 are provided separately. The output unit 18 is indicated by an arrow to show that it is provided for further purposes such as displaying determined operation commands for the user. In an option provided in addition to or instead of visually providing operation commands for the user, operation commands for the user are output in at least one of the following ways: acoustically and tactilely.

[0034] In Figure 1, the first hash arrow 22 indicates the input of current location data. The second hash arrow 24 indicates the input of 3D information of anatomical structures. Data input can be provided as live data relating to the input of current location data. In another example, the input of current location data is provided from a data storage device, for example, for testing or training purposes when operating a device in a model or simulation. 3D information of anatomical structures can be provided by a data storage device such as preoperative image data. 3D information of anatomical structures can also be provided as live data from live imaging, etc.

[0035] As a further option, the hash frame indicates a display 30 data-connected to output 18 (see below). In one example, the display is a monitor. In another example, the display is an image projection device that projects graphic information onto a projection surface, such as a handle of a device. In yet another example, the display is provided as an augmented reality display in which physical objects are combined with additional information, i.e., enhanced. For example, the display is provided as a head-mounted display for user wear. For example, the display is provided as goggles for user wear with a display of additional information, i.e., action commands are provided as projections in the user's view in a real-world situation. Thus, a head-up display with action commands for the user is provided.

[0036] Figure 2 shows the basic method steps of an example of method 100 for providing in-vivo navigation action commands. Method 100 has the following steps: In a first step 102, also referred to as step a), current position data of an anatomical part having a tool tip inserted into an anatomical structure within a region of interest is provided. In a second step 104, also referred to as step b), 3D information of the anatomical structure is provided. In a third step 106, also referred to as step c), target information is provided for the movement of the anatomical structure tip within the anatomical structure. In a fourth step 108, also referred to as step d), the current position of the anatomical structure tip within the anatomical structure is determined based on the current position data. In a fifth step 110, also referred to as step e), a movement specification is determined based on the target information and the determined current position in order to align the movement of the anatomical structure tip with the target information. In a sixth step 112, also referred to as step f), an action command to the user is determined based on the movement specification to achieve the movement of the anatomical structure tip in accordance with the movement specification. In the seventh step 114, also known as step g), an operation command is provided to the user.

[0037] The first, second, and third steps can be provided simultaneously or in any possible order.

[0038] In one example, a method for providing in-vivo navigation operation commands is provided. The method comprises the following steps: providing current position data of a catheter portion having a catheter tip inserted into a vascular structure within a region of interest; providing 3D information of the vascular structure; providing target information for catheter tip movement within the vascular structure; determining the current position of the catheter tip within the vascular structure based on the current position data; determining at least one of a group of movement specifications and trajectory information based on the target information and the determined current position in order to align the movement of the catheter tip with the target information; determining an operation command for the user to achieve the movement of the catheter tip in accordance with at least one of the group of movement specifications and trajectory information based on at least one of the group of movement specifications and trajectory information; and providing the operation command to the user.

[0039] For example, the following steps: - In order to align the movement of the tip of an anatomical structure with target information, the step of determining the movement specifications based on the target information and the determined current position, - A step of determining an action command for the user to achieve movement of the anatomical structure tip in accordance with the movement specifications and trajectory information, based on the movement specifications, It will be provided.

[0040] As another example, the following steps: - In order to align the movement of the tip of an anatomical structure with target information, the step of determining trajectory information based on target information and the determined current position, - A step of determining an action command to the user to achieve the movement of the anatomical structure tip in accordance with the trajectory information, It will be provided.

[0041] An example of in-vivo navigation is catheterization. Another example of in-vivo navigation is endoscopy. The term "in-vivo navigation operation command" refers to the operation of a maneuverable tool inserted into the body, for which tool navigation is provided.

[0042] The tool may be inserted for inspection, measurement, imaging, or sensing purposes, or to perform an intervention.

[0043] The term "internal navigation command" refers to the operation of catheter-based interventions, i.e., procedures in which a catheter is inserted into a target. Such procedures are called catheterization procedures. Internal navigation commands can also be referred to as catheterization procedure commands.

[0044] The term "operational instructions" refers to information and commands provided to a user for operating a device, such as a catheter. Operations can be provided manually and may also be powered or at least partially supported by motor drive. Operations can be provided directly or indirectly. Operational instructions may also be referred to as operational guidance or control guidance. For example, operational instructions may relate to recommended actions to be performed by the user. For example, operational instructions may relate to steering commands or control commands. For example, operational instructions may relate to operational procedures or workflows. For example, operational instructions may relate to tool operations, also referred to as steering operations, when moving a tool, such as moving a catheter within a vascular structure.

[0045] In one example, the tool is the catheter portion that has the catheter tip.

[0046] For example, an anatomical structure may be a vascular structure, or a cardiac chamber structure, or a lumen of another organ. An anatomical structure may also be a histological region.

[0047] The term "positional data supply" refers to providing spatial information about a tool, such as the tip of a catheter, i.e., its position in space in relation to anatomical structures. Positional data supply may also be referred to as positional data input or position input.

[0048] The term "anatomical data supply" refers to providing spatial information about the anatomical structures of a region of interest. Anatomical data supply is also called 3D anatomical data supply or anatomical 3D data supply. Anatomical data refers to vascular structures, i.e., three-dimensional information about blood vessels within a region of interest. Anatomical data supply can also be called anatomical data input or anatomical input.

[0049] The term "target information" refers to the target location within a vascular structure and / or movement information for a tool to be tracked, such as a catheter tip. Therefore, the target can be a track to be followed, such as a specific blood vessel. Thus, the target can also be a point or location to which a catheter tip or another type of tool should be moved. Target information may be manually set before or during intervention, or determined by further imaging procedures (including AI-driven diagnostic tools).

[0050] For example, target information for the movement of the catheter tip within a vascular structure can be provided separately, such as through user input.

[0051] Anatomical data supply can be provided as a data feed connected to a data source. Anatomical data supply can also be provided as a data storage device connected to a processor.

[0052] In the options, the positional data supply unit and the anatomical data supply unit are provided as an integrated supply unit that provides a data input interface. The supply unit may also be referred to as an input, input unit, or data input interface.

[0053] The term "processor" relates to data processing. A processor may also be called a data processor, data processing device, or processor unit. For example, a processor may be data-connected to a location data supply unit, an anatomical data supply unit, and a user interface.

[0054] The "movement specification" relates to the movements that a tool tip, such as a catheter tip, must perform to move according to target information. The movement specification provides navigation commands related to the path within the vascular structure given by the target information.

[0055] "Trajectory information" refers to the path, i.e., the planned trajectory that a tool tip, such as a catheter tip, must follow to move along that path as it approaches a target. Trajectory information provides navigation instructions regarding the path within the vascular structure given by target information.

[0056] The term "output" refers to providing the user with generated operation commands. The output unit may also be called an output section. In one example, the output unit can be data-connected to a user interface, such as a display configuration. The user interface may also be called an instructor. In one example, the user interface provides operation commands in at least one of the following ways: visual (seeing), tactile (feeling), and auditory (hearing).

[0057] The operation commands are provided to allow the catheter tip to move forward until the target position is reached.

[0058] In one example, a device for in-vivo navigation operation commands is provided. The device comprises a position data supply unit, an anatomical data supply unit, a processor, and an output unit. The position data supply unit is configured to provide current position data of a catheter portion having a catheter tip inserted into a vascular structure within a region of interest. The anatomical data supply unit is configured to provide 3D information of the vascular structure and target information for the movement of the catheter tip within the vascular structure. The processor is configured to determine the current position of the catheter tip within the vascular structure based on the current position data, determine a movement specification based on the target information and the determined current position in order to align the movement of the catheter tip with the target information, and determine an operation command to the user to achieve the movement of the catheter tip according to the movement specification based on the movement specification. The output unit is configured to provide the operation command to the user.

[0059] In one example, the anatomical data supply unit is further configured to provide data representing at least anatomical structures, such as a graphical representation of the anatomical structures of a region of interest.

[0060] Optionally, the processor can be configured to generate image data showing the tool tip at its current position within the context of an anatomical structure.

[0061] As a further option, the output unit is a display 30, which is configured to display image data of the tool tip and anatomical structures in combination with operation commands.

[0062] In one example, data representing a graphical representation is provided as pre-recorded or predetermined image data.

[0063] In one example, the processor is configured to display annotations or tags for anatomical structures shown in the image data.

[0064] In one example, data representing a graphical representation is provided as a live image from an image acquisition device.

[0065] As an option, an image acquisition device can be attached to the tool tip area.

[0066] In one example, the image acquisition device is an ultrasound imager, such as an IVUS (intravascular ultrasound) sensor.

[0067] In one example, the operation command may also contain directional information regarding the catheter tip relative to the vascular structure, such as a navigation command.

[0068] In one example, the operation command has instructions for the user to operate the control handle of the catheter, the catheter has a catheter tip attached to it, and the catheter tip is configured to be operated within the vascular structure of the region of interest. In one example, the operation control is provided as at least one of a group such as a control knob, adjustment wheel, joystick-like element, touch control, or button on a display.

[0069] As a result, the operational commands are interpreted according to the view provided to the user.

[0070] Therefore, the navigation portion is operated by the device itself, and the load that translates the navigation into actual (manual) actions by the user to control catheter movement is also operated by the device itself. Thus, the user can easily and directly execute action commands.

[0071] In one example, it is used in conjunction with haptic and tactile feedback while guiding the catheter along the vascular structure, in addition to or instead of visual motion commands. For instance, the user generates an impression of feeling the vascular wall, for example, in an improved, i.e., increased or amplified, manner.

[0072] The colors, patterns, and shapes are provided to be distinguishable in order to facilitate the easy transfer of user information.

[0073] For example, indicators such as superior / inferior, left / right, anterior / posterior, distal / proximal, and other anatomical structure-specific indicators are not present on the control handle or within the provided operating instructions.

[0074] In one example, the output unit is configured as a user interface that provides the user with operation commands and also allows the input of user commands.

[0075] In one example, the control handle interface is configured to receive handle position data having at least one of the following groups: orientation in space, position relative to the object, and distance between the control handle and the catheter tip. The processor is further configured to determine an action command based on at least one of the following groups: orientation in space and position relative to the object.

[0076] The distance between the control handle and the catheter tip affects the amount of elasticity, and therefore this is taken into consideration.

[0077] Therefore, the operation instructions are provided as context-sensitive instructions.

[0078] The direction of the handlebars can be tracked, for example.

[0079] Spatial location is provided for augmented reality.

[0080] As a further option, the processor is further configured to determine adapted operational commands based on a pre-modeled model or measurement-based wire elasticity and stretch. In one example, a measurement-based solution includes a continuous analysis of orientation and angular rotation sensing at both the catheter tip (possibly via imaging) and the control handle, and modeling of the catheter tip rotation response to rotational input to the control handle.

[0081] In one example, a 180° rotation of the handle results in only a 90° rotation at the tip due to the elasticity of the wire shaft. Depending on the length of the outer part of the body, this different movement behavior is taken into consideration when determining the motion command.

[0082] In one example (furthermore, not shown), an action command is provided as augmented reality by overlaying the command onto an image of a control handle.

[0083] In the options, navigation information is displayed in addition to the operation instructions, and the operation instructions are separated from the navigation information.

[0084] In one example, at least one of a group of action commands and navigation information is provided as augmented reality overlaid on a live image of the current situation. Optionally, action commands are overlaid on the tool's physical control handles.

[0085] In one example, navigation provides at least one indicator from a group such as movement path, direction of movement, speed of movement, turning points, branches, and curves. Thus, navigation information relates to spatial movement along a target path. Conversely, action commands provide instructions to the user on how to operate the catheter to achieve movement according to the navigation information.

[0086] In one example, the anatomical data supply unit is further configured to provide data that enables at least two different views of the anatomical structure of the region of interest. The processor is configured to generate image data showing the tool tip in different views, depending on at least one of a group of action instructions and the complexity of the approaching junctions.

[0087] The term "different view" refers to a change in at least one of the following groups: observation direction, field of view, and field of view resolution.

[0088] For example, the user, i.e., the operator, can switch from a neutral external view to a view from the perspective of the catheter tip. In one example, automatic switching is provided.

[0089] In one example, to achieve target information, the start or entry position and the target or exit position for catheter movement are determined, and the processor calculates at least one route for moving the catheter from the entry position to the target position. Optionally, different routes can be selected depending on other parameters such as the geometric and physical properties of the catheter and catheter tip.

[0090] Figures 3a and 3b show examples of in-vivo navigation command instructions presented to the user. An angiographic image 32, or another representation of a vascular structure or another anatomical structure, is shown in the upper half of Figures 3a and 3b. A partially inserted device 34 is shown, and a target point 36 is indicated. An additional image 38 of the inside of a blood vessel is shown in the lower right portion of Figures 3a and 3b. An indicator 40 of the target movement path may be provided. The additional image 38 may be an ultrasound image. The lower left portion of Figures 3a and 3b shows a command instruction 42 in the form of a handle 44 having an indicated direction of movement, for example, with respect to the handle 44. In addition, navigation information 46, such as a map, can also be provided, as well as the navigation command 48, which is provided as text.

[0091] A representation of the vascular structure is provided for overview purposes. In addition (not shown), a predetermined route, i.e., a path within the vascular structure to target point 36, may be shown. Thus, the representation of the vascular structure provides a kind of roadmap.

[0092] Additional image 38 provides a personal perspective to the user, as if the user were operating the device within a blood vessel. Thus, additional image 38 provides a cockpit view from the tip of the device. Target movement path indicators 40 provide a further understanding of the direction of movement. Instead of target movement path indicators 40, the indicators may also present the distal end of the device.

[0093] Map-like navigation information 46 provides the user with abstract navigation information related to the indicated portion of the map. Thus, map-like navigation information 46 provides the user with primary source information about where the movement should be directed. However, this navigation is provided in relation to the map and needs to be translated by the user to the steering wheel.

[0094] The operation commands 42 provide such information in relation to an operating device, such as a steering wheel 44. Thus, the operation commands 42 provide the user with intuitive and direct instructions on how to perform the steering wheel's movements to achieve desired navigation through the vascular structure to reach a target point in a desired manner along a desired path. Thus, the operation commands 42 are provided within the context of the steering wheel, and the user can follow them directly.

[0095] Figure 3a shows a rather easy-to-maneuver situation, as indicated by the straight green arrow (shown in black in Figure 3a) above the handle 44. The current vascular section is only slightly bent without branching. Providing operational commands allows the user to move the tip of the device forward.

[0096] Figure 3b illustrates a situation requiring more maneuvering attention, as indicated by a larger blue arrow (shown in gray in Figure 3b) that curves to the right (in the image), a smaller red arrow (shown in black in Figure 3b) that acts on the first control knob to the left, and a smaller orange arrow (shown in white in Figure 3b) that acts on the second control knob to the right. The current vascular section has complex branching, and the target pathway continues to the left. Providing action commands allows the user to operate in this situation.

[0097] Figure 4 shows an example of a catheter system 50. The catheter system 50 further includes a catheter 52 having a catheter body and a catheter tip, along with a control handle (not shown). The catheter system 50 further includes an example 54 of a device 10 for in-vivo navigation operation commands according to one of the examples described above. The catheter tip is attached to one end of the catheter body, and the catheter control handle is connected to the catheter body toward the other end. The operation commands include instructions for the user to operate the control handle to manipulate the catheter tip when it is inserted into a vascular structure in the region of interest.

[0098] Optionally, the catheter features an integrated optical fiber, and a laser is provided to send laser light into the fiber so that it is reflected back along the fiber for analysis to reconstruct and visualize the complete shape of the catheter.

[0099] This is based on the concept of measuring strain in optical fibers using light reflected from density variations in these fibers. Called FORS (Fiber Optic Real Shape), this technique enables real-time 3D visualization of the complete shape of a catheter inside the body without requiring continuous imaging, such as X-ray imaging. The catheter can be shown in the context of the patient's anatomical structure through integration with images obtained by preoperative or intraoperative techniques (CT, MRI, or X-ray fluoroscopy). Thus, clinicians can clearly see where and how the device needs to be navigated and positioned within the anatomical structure.

[0100] This assists surgeons who need to view the device in 3D in real time relative to anatomical structures, while simultaneously reducing radiation exposure for patients, staff, and the surgeon themselves. FORS also enables visualization in multiple, user-controlled, and unrestricted fields of view in relation to the patient's anatomical structure (using overlays from preoperative 3D anatomical data or intraoperative X-ray images). The FORS system provides 3D information to reduce the risk of procedure in terms of potential vascular damage and reduces procedure time as surgeons can navigate anatomical structures with greater confidence and efficiency. 3D-shaped catheters can be shown overlaid on CT / MRI / X-ray images of the subject. Thus, clinicians are provided with an even more improved visualization of where and how the device needs to be navigated and positioned within the anatomical structure.

[0101] In one example, a map of vascular anatomical structures is created using imaging techniques, such as CT or X-ray angiography.

[0102] Figure 4 shows an example catheterization lab 60. The catheterization lab 60 has an X-ray imaging system 62 having a C-arm 64 that is movably supported by an imaging system, such as a ceiling mount 66. An X-ray source 68 and an X-ray detector 70 are provided to image an object 72 placed on a target support 74. A control and display interface 76 is provided next to the target support 74. A monitoring device 78 is also shown. Illumination 80 is also provided.

[0103] An example 54 of the device 10 for in-vivo navigation operations is provided in the context of a workstation or console 82. The console 82 has a display 84, a keyboard 86, and a mouse 88. Furthermore, a control console 90 and a graphics tablet 92 are shown.

[0104] In one example, the surgeon points to or identifies a starting point, such as the groin or arm of the subject, or a point of interest, such as the heart.

[0105] For example, a vascular navigation system calculates a route from a starting point to a point of interest. It is possible for the system to choose to calculate alternative routes to the primary route, taking into account factors such as catheter size and bending capacity, the size of the implant being delivered, and safety-efficiency trade-offs. This provides the surgeon with the option to select the best route for themselves at a given moment, thus overriding the default criteria used by the system to generate the primary route.

[0106] In one example, the surgeon feeds the catheter into the blood vessel and makes turns based on real-time guidance provided by the device, namely the distance to the upcoming junction, the next 3D turn to take, and the recommended forward speed. The device may also inform the surgeon of the speed of movement when a complex vascular section is reached, for example, by slowing down in a complex vascular section and accelerating when it is not a very complex vascular section.

[0107] In complex environments, devices for catheter procedures can provide more detailed instructions. For example, devices for in-vivo navigation, also known as vascular maneuvering support devices, provide detailed instructions on which branch to take at a junction.

[0108] For example, a fundamental difference from a car navigation system is that a device for in-vivo navigation commands provides the surgeon with instructions on which control devices on the catheter should operate, how and to what extent, in order to safely maneuver the catheter. The device may provide the surgeon with audio, visual, and tactile cues on what to do at specific points along the route.

[0109] As shown above, the device may change the view settings of the imaging device (e.g., ICE, IVUS, OCT) at the catheter tip depending on the vascular shape being navigated. In more linear sections, the image settings may have deeper, more forward-looking view settings, while as the device approaches a junction, the real-time view of the anatomical structure may switch to an optimal 3D view or 2D plane, visualizing the anatomical structure with respect to the device and the branch to be navigated. This provides the possibility of selecting a more appropriate and relevant view at the catheter tip to make the surgeon's movements more intuitive. Some view settings provide a better view than others depending on the exact position of the tip at that point. These settings can also help to better estimate the device-anatomical structure distance, which makes it more intuitive for the operator (surgeon) to maneuver the catheter through the junction. Images can be segmented into a 3D model to render vascular features in a more useful way to support navigation.

[0110] Figure 5 shows a further example of a workflow, or procedure, related to providing in-vivo navigation action commands.

[0111] As preparation, subject 202 undergoes an imaging procedure to generate a CT angiography 204. This data is further processed into an angiography, e.g., a CT angiography of the subject 206, and the results are stored in a data storage element. The surgeon 210 annotates this data by identifying entry points into vascular anatomical structures and points of interest where diagnostic or interventional procedures must be performed 208. The annotated data, also referred to as annotated CT angiography data 212, is stored in a data storage element. A routing algorithm 214 reads the annotated angiography data from the data storage element and calculates the route from the entry points within the vascular anatomical structures to the points of interest. The routing algorithm can be optimized based on individual anatomical differences, catheter capabilities, e.g., the bending ability of the catheter tip, and the size of the catheter. The routing algorithm can also take into account the size of the folded implant to which the catheter is delivering. The routing results in a routing description 216. The surgeon can begin the operation, and the guidance algorithm 218 receives input from live catheter FORS data 220, annotated angiographic data and descriptions from memory elements, as an example. The guidance is displayed in frame 222. The guidance algorithm can further calculate the position of the catheter within the vascular anatomical structure by overlaying the angiographic data, routing description data, and FORS data. When a junction within the anatomical structure is reached, the guidance algorithm can show a 3D representation of the junction, as well as the position and orientation of the catheter within the anatomical structure, along with an indicator of which exit to take. The guidance algorithm then calculates cues for the surgeon to manipulate the catheter within the anatomical structure. When further away from the point of interest and on a less complex section of the anatomical structure, the guidance algorithm may guide the surgeon so that it is safe to feed the catheter faster—a safe speed can be calculated from the anterior width and curvature of the vascular system (from the angiographic image) with respect to the size and tip position of the catheter. The catheter insertion speed can be monitored from the FORS shape with respect to the angiographic image.This allows for quantitative velocity guidance, accompanied by a warning if the feed is too fast. As the catheter approaches a point of interest or a more complex section of an anatomical structure, the algorithm signals the surgeon to slow down. When a junction in the vascular anatomy is reached, the algorithm uses FORS data to calculate translational and clocking, yaw, and pitch operations to orient the catheter to the correct branch. The bending angle of the catheter tip is calculated. The surgeon 210 is informed which controls on the catheter handle to operate and by how much to safely navigate to the point of interest. This can be achieved by providing optical signals on the catheter control handle, augmented reality projection on the control handle (via AR glasses worn by the surgeon), indicators on the control handle representation on the navigation guidance display, or by any other method. It should be noted that the guidance may take into account discrepancies between the control operations and the catheter tip behavior due to torsional constraints, catheter feed length, etc. For this purpose, it may use known catheter properties, simulations, and / or real-time sensing and mapping of the control operations with respect to the catheter movement.

[0112] Different view settings of imaging devices (e.g., ICE, IVUS, OCT) at the catheter tip can be used to obtain a better real-time view of anatomical structures in complex sections of vascular anatomy. These can be 3D U / S volume, optimal 3D view, or 2D plane, visualizing the device-anatomical and vascular structure distances. Guidance algorithms automatically change these view settings based on the catheter's position within the vascular system. Signals to the surgeon can be provided by audio, tactile, video, augmented reality, or a combination thereof.

[0113] Please note that the term "subject" may also be referred to as an individual. Furthermore, "subject" may also be referred to as a patient, but please note that this term does not indicate whether a particular disease or illness actually exists in the subject.

[0114] As an example, a computer program is provided that enables a processor to perform the method described in the example above.

[0115] In one example, a computer program or program element for controlling a device according to one of the above examples is provided, and this program or program element is configured to perform one of the method steps from the above example when executed by a processing unit.

[0116] In one example, a computer-readable medium storing the program elements of the aforementioned example is provided.

[0117] It should be noted that the present invention can be used in any medical field in which a catheter is used to navigate through the vascular system in the context of treating a patient through a minimally invasive procedure. It can be used in a hybrid catheterization laboratory where such a procedure is performed and additional image-guided therapeutic devices are present. In the case of X-ray, the present invention can be used, for example, in a Philips catheterization laboratory equipped with an Azurion or Allura system, or with ICE, IVUS, OCT, FORS, etc. The proposed guidance may also be used in combination with an (autonomous) catheter robot, which the surgeon can disable as needed and continue manually using navigation guidance.

[0118] In another exemplary embodiment of the present invention, a computer program or computer program element is provided, which is configured to perform a method step of the method according to one of the above embodiments on a suitable system.

[0119] Accordingly, the computer program elements may be stored in a computer unit or distributed across one or more computer units, which may be part of embodiments of the present invention. This computing unit may be configured to perform or induce the execution of the steps of the method described above. Furthermore, it may be configured to operate the components of the apparatus described above. The computing unit may be configured to operate automatically and / or to perform user orders. The computer program may be loaded into the working memory of a data processor. Accordingly, the data processor may be configured to perform the method of the present invention.

[0120] Aspects of the present invention may be implemented in a computer program product, which may be a collection of computer program instructions stored on a computer-readable memory device that can be executed by a computer. The instructions of the present invention may include, but are not limited to, scripts, interpretable programs, dynamic link libraries (DLLs), or Java classes, and may be any interpretable or executable code mechanism. The instructions may be provided as a complete executable program, a partial executable program, a modification (e.g., an update) to an existing program, or an extension (e.g., a plug-in) to an existing program. Furthermore, some of the processing of the present invention may be distributed across multiple computers or processors.

[0121] As described above, a processing unit, such as a controller, implements a control method. This controller can be implemented in various ways using software and / or hardware to perform various required functions. A processor is an example of a controller that uses one or more microprocessors that can be programmed using software (e.g., microcode) to perform the required functions. However, the controller may be implemented with or without a processor, and may be implemented as a combination of dedicated hardware for performing some functions and a processor (e.g., one or more programmed microprocessors and associated circuits) for performing other functions.

[0122] Examples of controller components used in various embodiments of this disclosure include, but are not limited to, conventional microprocessors, application-specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs).

[0123] This exemplary embodiment of the present invention encompasses both computer programs that use the present invention from the outset and computer programs that, by means of updating, transform an existing program into a program that uses the present invention.

[0124] Furthermore, the computer program elements may provide all the steps necessary to satisfy the procedures of the exemplary embodiment of the method described above.

[0125] According to a further exemplary embodiment of the present invention, a computer-readable medium, such as a CD-ROM, is presented, and the computer-readable medium has computer program elements stored therein, which are described in the preceding section. The computer program may be stored and / or distributed on a suitable medium, such as an optical storage medium or a solid-state medium, supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless communication systems.

[0126] However, computer programs may be presented on a network such as the World Wide Web and can be downloaded from such a network into the working memory of a data processor. According to a further exemplary embodiment of the present invention, a medium for making a computer program element downloadable is provided, and this computer program element is configured to perform a method according to one of the aforementioned embodiments of the present invention.

[0127] It should be noted that embodiments of the present invention are described with reference to different subject matter. In particular, some embodiments are described with reference to method-type claims, and other embodiments are described with reference to apparatus-type claims. However, those skilled in the art will understand from the above and below descriptions that, unless otherwise notified, any combination of features belonging to one type of subject matter, as well as any combination of features relating to different subject matter, are also disclosed in this application. However, all features can be combined in such a way that they provide a greater synergistic effect than the simple sum of the features.

[0128] Although the present invention is illustrated and described in detail in the drawings and the foregoing description, such illustrations and descriptions should be considered illustrative or typical and not limiting. The present invention is not limited to the disclosed embodiments. Other variations of the disclosed embodiments can be understood and achieved by those skilled in the art in carrying out the claimed invention from a consideration of the drawings, disclosure and dependent claims.

[0129] In the claims, the word “have” does not preclude other elements or steps, and the indefinite article “a” or “an” does not preclude plurality. A single processor or other unit may fulfill the functions of several items described in the claims. The mere fact that certain means are mentioned in different dependent claims does not imply that combinations of these means cannot be used advantageously. No reference numeral in the claims should be construed as limiting in scope.

Claims

1. Location data supply unit, Anatomical data supply unit, Processor and Output section, In a device for in-vivo navigation operation commands having, The position data supply unit is configured to provide current position data of a tool portion having a tool tip inserted into an anatomical structure within the region of interest of the target. The anatomical data supply unit is configured to provide 3D information of the anatomical structure and to provide target information for the movement of the tool tip within the anatomical structure. The processor is configured to determine the current position of the tool tip within the anatomical structure based on the current position data, to determine at least one of a group of movement specifications and trajectory information based on the target information and the determined current position in order to align the movement of the tool tip with the target information, and to determine an action command to the user to achieve the movement of the tool tip in accordance with at least one of the group of movement specifications and trajectory information based on at least one of the group of movement specifications and trajectory information. The operation command relates to commands relating to the operation of the operating interface for the operation and functioning of the device, the operation command has operation commands for the user in a manner that is adapted to the user's operating situation, the operation command is an input operation or operation by the user, which results in appropriate navigation, The output unit is configured to provide the operation command to the user, The operation command comprises instructions to the user for operating the control handle of the tool, the tool tip is attached to the tool, and the tool tip is configured to be operated within the anatomical structure of the region of interest of the object, The operation command is provided as an operation command for the user on how to operate a plurality of motion control devices of the control handle of the tool, the motion control devices with respect to the direction of movement of the tip, the bending of the tip portion, and the movement vector of the tip. A control handle interface is further provided, configured to receive and provide to the processor position data of the control handle having at least one of the group of orientation in space, position relative to the object, and distance between the control handle and the tool tip. The processor is further configured to determine the operation instruction based on at least one of the group of orientation in space, position relative to the object, and distance between the control handle and the tool tip. Device.

2. The tool is a catheter, and the tip of the tool is the tip of the catheter. The aforementioned anatomical structure is a vascular structure. The apparatus according to claim 1.

3. Data representing at least a graphical representation of the anatomical structure in the region of interest is provided, and the processor is configured to generate image data indicating the tool tip at its current position in the context of the anatomical structure. The output unit is a display configured to show the image data having the tool tip and the anatomical structure in combination with the operation command. The apparatus according to claim 1 or 2.

4. The data representing at least the graphical representation of the anatomical structures in the region of interest is provided as live images from an image acquisition device. The image acquisition device is attached to the area of ​​the tool tip, The apparatus according to claim 3.

5. The plurality of operation control devices are provided with at least one graphic indicator of the handle that is visible to the user, The aforementioned operation command relates to the graphic indicator, For visual distinction, the graphic indicator has at least one of the groups of color, pattern, and shape. The apparatus according to any one of claims 1 to 3.

6. The control handle interface is configured to receive handle information relating to the operation control device of the control handle and provide it to the processor. The processor is further configured to determine the operation instruction based on the handle information. The apparatus according to any one of claims 1 to 5.

7. The aforementioned operation command is provided as augmented reality by overlaying the command onto the image of the control handle. In addition to the aforementioned operation commands, navigation information is provided, and the operation commands are separated from the navigation information. The apparatus according to any one of claims 1 to 6.

8. The anatomical data supply unit is further configured to provide data that enables at least two different views of the anatomical structure of the region of interest, The processor is configured to generate image data showing the tool tip in different views, depending on at least one of the group of operation instructions and the complexity of the approaching joints. The apparatus according to any one of claims 1 to 7.

9. A catheter having a control handle, a catheter body, and a catheter tip, A device for issuing internal navigation operation commands according to any one of claims 1 to 8, In a catheter system having, The catheter tip is attached to one end of the catheter body, and the control handle is connected to the catheter body toward the other end of the catheter body. The operation command includes a command for user operation of the control handle for manipulating the tip of the catheter when it is inserted into a vascular structure in the region of interest. Catheter system.

10. The catheter comprises an integrated optical fiber, and a laser is provided to send laser light into the fiber such that it is reflected back along the fiber for analysis to reconstruct and visualize the complete shape of the catheter, according to claim 9.

11. In a method for operating a device for in-vivo navigation operation commands, the device comprises a position data supply unit, an anatomical data supply unit, a processor, and an output unit, and the method is: The position data supply unit provides current position data of an anatomical structure portion having a tool tip inserted into an anatomical structure within the region of interest of the target, The anatomical data supply unit provides 3D information of the anatomical structure, The anatomical data supply unit provides target information for the movement of the tip of the anatomical structure within the anatomical structure, The processor determines the current position of the tip of the anatomical structure within the anatomical structure based on the current position data, The processor determines at least one of a group of movement specifications and trajectory information based on the target information and the determined current position in order to align the movement of the tip of the anatomical structure with the target information. Steps include: the processor determining an action command to a user to achieve movement of the tip of the anatomical structure in accordance with at least one of the movement specifications and the group of trajectory information, wherein the action command relates to an instruction relating to the operation of an operating interface for the operation and operation of the device, the action command has an operation command for the user in a manner that is adapted to the user's operating situation, and the action command is an input operation or operation by the user, resulting in appropriate navigation; The output unit provides the operation command to the user, It has, The operation command comprises instructions to the user for operating the control handle of the tool, the tool tip is attached to the tool, and the tool tip is configured to be operated within the anatomical structure of the region of interest of the object, The operation command is provided as an operation command for the user on how to operate a plurality of motion control devices of the control handle of the tool, the motion control devices with respect to the direction of movement of the tip, the bending of the tip portion, and the movement vector of the tip. The apparatus further includes a control handle interface configured to receive and provide to the processor position data of the control handle, which has at least one of the group of orientation in space, position relative to the object, and distance between the control handle and the tool tip. The processor is further configured to determine the operation instruction based on at least one of the group of orientation in space, position relative to the object, and distance between the control handle and the tool tip. method.

12. A computer program that enables a processor to perform the method according to claim 11.

13. A computer-readable medium storing the computer program described in claim 12.

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