JP2006519629A - Remote control of medical devices using virtual device interfaces - Google Patents

Abstract

An interface system and method for controlling a magnetic surgical system is provided that displays a virtual image of a device, adjusts the configuration of the device, or until the displayed device is portable to the user's desired configuration. Adjust the actuation control information applied to the or select the desired target position of the chip and apply it to the actual device of the set of actuation control information so that the actual device takes the form of a virtual device or device This is done by manipulating the tip to the desired position.

Description

  The present invention relates to remote control of medical devices within an object or subject's body, and more particularly to a user interface for operating a medical device capable of remote control using a “virtual device” interface. .

  With the development of technology, a system has been developed that allows a physician or other medical professional to remotely control the direction of the distal end of the medical device. It is common practice today to maneuver the distal end of a medical device within a subject's body by mechanically manipulating control means on the proximal end of the medical device. In recent years, magnetic navigation (guidance) systems have been developed that allow a physician to determine the direction of the tip of a medical device using the magnetic field of an external source magnet (magnet). Other systems have been developed for automatic remote orientation of the tip of a medical device, for example, by operating a magnetostrictive element or electrostrictive element incorporated in the medical device. Although the medical device can be controlled, the doctor visualizes the treatment site (in the patient and out of sight), selects the desired direction to align the tip of the medical device, It can still be difficult to communicate the selected direction to the system in order to point the tip of the medical device in the selected direction.

As described above, a controlled magnetic field is applied (formed and applied) to the treatment region (operating region) of the subject, and the magnetic response element on the medical device is oriented in the treatment region. A magnetic navigation system was developed. Such a system is, for example, a US patent issued to Ritter et al. Under the name “Open Field System For Magnetic Surgery” dated June 5, 2001. No. 6,241,671 (incorporated herein by reference). A magnetic navigation system is faster and simpler to navigate than a normal mechanically navigated device that needs to include pull wires and other components to steer the device. Can be made thinner and more flexible. With advances in magnetic surgery systems and magnetically responsive medical devices, determining the proper magnetic field direction, and commanding the magnetic surgical system to provide the determined magnetic field, Probably the most difficult task left for magnetically assisted medical procedures. Great efforts have been made to help the user see the treatment (behavior) and to improve it so that the user can control the magnetic surgical system during the treatment period. There is often a lag between the direction of the applied magnetic field and the actual direction of the tip of the medical device. Some current systems require the user to specify the direction of the magnetic field and to consider (draw) in mind the delay (deviation) between the applied magnetic field and the actual device direction.
U.S. Pat.No. 6,241,671

SUMMARY OF THE INVENTION The present invention relates to a method and apparatus for controlling a flexible medical device in a body of a subject, and relates to a virtual device interface, ie, a physical or computational model of the actual device. And possibly using an interface including a computed control interface for real-time / interactive navigation control of the device. Such a calculated device control interface receives user input information from an input device (eg, joy-stick), interprets these inputs by a computer, and maps the device chip according to a pre-specified mapping. Proper control for driving is performed. In general, the method of the present invention comprises the steps of displaying an image of the tip portion of a “virtual” medical device, and displaying a display image of the tip portion of the virtual medical device in a desired configuration. Arrangement) (shape and / or orientation) to be manipulated or processed, and then the desired medical device tip portion is represented by a virtual device image. Remotely operating the device to take.

  In a preferred embodiment of the system and method of the present invention, the displayed virtual medical device configuration (configuration) is the target point (target) that the virtual medical device itself configures. It can be controlled by identifying points. In other preferred embodiments, controls that change the shape of the virtual medical device, such as deflection control and rotation control, are used to control the morphology. In yet another preferred embodiment of the system and method of the present invention, the displayed virtual medical device form is “as if” at least one control parameter has been changed (a special case of a magnetically controlled device). Change at least one parameter (eg, a given magnetic field for a magnetically controlled device) to indicate the shape of the tip of the virtual medical device (as if a new magnetic field was given) It can be changed by updating the image of the virtual medical device. In other preferred embodiments, the user can identify the location of the target and the interface uses a virtual device model to determine one or more control parameters for causing the actual device to reach the target. To do. In yet another preferred embodiment of the system and method of the present invention, a surface comprising a plurality of possible points of the tip of the medical device is displayed. The user can then select a point on the surface and operate the system to automatically provide the correct magnetic field to align the tip of the medical device in the direction of the selected point.

  A preferred embodiment of the present invention is a specification related to a magnetic field applied to a treatment region (surgical region) in an object or a subject in order to control a distal end of a medical device in the operating region (surgical region). And an interface system and method for facilitating the formation of the magnetic field. The present invention can provide a method and apparatus for controlling a magnetic navigation system, in particular for a magnetically operated (enabled) medical device in a patient treatment area (surgical area). Provided are an interface system and method for facilitating (facilitating) the specification of a magnetic field to the patient's treatment area (surgical area) to control the tip and the formation of the magnetic field. However, the virtual device interface of the present invention is not so limited and can be used with any system for controlling the form of a medical device and can be activated by any of a variety of means. Can do. Further, the interface can be used with any elongated medical device including guide wires, catheters, endoscopes and the like.

  In accordance with the system and method of the present invention, a user can provide a tip of a medical device prior to actually supplying one or more variables that are used to change the configuration or configuration of the medical device. The form or arrangement can be seen (visualized). This allows them to learn and operate faster and more easily than many currently used user interfaces. For example, some currently used magnetic navigation interfaces require the user to specify the direction of the magnetic field without considering (referring to) the current direction of the tip portion of the medical device. The system and method of the present invention can also easily automate the procedure (procedure) that combines an advancer with a directional control means to advance the medical device. Furthermore, according to the present invention, the user directly operates the tip of the apparatus in an interactive or interactive form using the input device, and the operation of the input device by the user is actuated by a computer (actuation). It is mapped to changes in the control variable and then causes a corresponding change in the configuration of the device. Changes in the configuration of the device can be visually displayed to the user using any of a variety of imaging systems, thereby allowing the user to control interactively throughout the device. The input device for this purpose may be, for example, a joystick, a graphical menu button, a keyboard button, or any other well known to the technical specialization You may choose The mapping method for mapping the operation of the input device to the change in the operation control of the device may be selected from various methods for performing intuitive spatial control of the device. A selection of possible mapping choices is provided to the user, which allows the user to adopt the one that the user feels most appropriate within a given navigation environment. These features, other features, and advantages will be apparent in part and in part below.

  The same reference number represents the same corresponding part throughout the several views.

  The virtual device interface of the present invention can be used with any type (form) of medical device that can be remotely controlled, including, for example, medical devices that can be mechanically, electrically, and magnetically actuated. Can be used. One possible use of the present invention is in the control of a magnetically actuable (startable) device, for example using the magnetic navigation system shown in FIG. In the following, a preferred embodiment in the form of a magnetic surgery system in cooperation with an X-ray imaging system will be mainly described, but the present invention is not limited to this. For example, a magnetic resonance imaging system can be used that steers a catheter with torque generated by using a variable magnetic moment placed on a medical device that interacts with the static magnetic field of the magnetic resonance imaging system. . Similarly, any other imaging modality or working modality can be employed.

  As shown in FIG. 1, a magnetic surgery system is installed in a treatment room 50 and a control room 52 where a patient is placed. The control room 52 is preferably adjacent to the treatment room 50 and a window 54 may be provided between the control room 52 and the treatment room 50 so that the patient can be observed directly. However, the control room can also be separated from the patient, and with the help of the interface of the present invention, doctors can treat patients in the treatment room from different floors, from different buildings, even from control rooms in different towns. Can be applied.

  The magnetic surgical system is operated by a patient bed 56 and a processor 64 and opposed magnets disposed on both sides (opposite sides) of the patient bed controlled by control means 66 adjacent to the patient 56. And a magnetic navigation system 58 that includes units 60 and 62. An imaging system 68, such as an X-ray imaging system on the C-arm, displays an image of the treatment area on a set of monitors 70 in the treatment room 50. The interface system of the present invention provides a convenient way for a user to navigate (guide, steer or manipulate) a magnetic navigation system 58 to control the tip of a medical device in a treatment area within a patient's body. provide.

  The interface is a display (display) in the treatment room 50, for example on the LCD monitor 72, and a display (display) on the processor 76, for example in the monitor 78, in the digital tablet 74, the control room 52 (54). ), A keyboard 80, and a mouse / digital tablet 82. Additional displays that integrate multiple images from the imaging system 68 using an interface may be provided on monitors 86 and 88 in the treatment room 50. One or more monitors 90 can be additionally provided in the control room so that images can be used in the control room as well. The monitor 90 preferably displays a multi-pane display (multi-pane display, multi-screen display, multi-frame display).

  In one preferred embodiment of the invention shown in FIG. 2, one of the displays, for example display 90, is a pane (pane, glass plate, display pane, frame) 92 that receives a bi-directional image of the treatment area. And 94. Display 90 preferably comprises a control pane 96. As shown in FIG. 2, the user selects a discrete set of points for the medical device tip to characterize the medical device. In a preferred embodiment, the treatment area is bi-planar imaging (imaging) (such as bi-plane fluoroscopy) and in separate planes, preferably planes orthogonal to each other. Two images are displayed: an image of the treatment area and an image of the tip of the medical device. For example, a two-way imaging system may cause panes 92 and 94 to display a left anterior oblique (LAO) and right anterior oblique (RAO) image of the treatment area, respectively. . Two-way imaging can be provided using a single x-ray source and imaging plate that move together (in tandem back and forth) to perform imaging in multiple planes or multiple planes. It will be possible.

The user preferably identifies a “support” point or “pivot” point x ₁ of the tip portion of the medical device on each of the panes 92 and 94. A user uniquely identifies a point in three-dimensional space by identifying points in both planes. Also, the user preferably identifies the tip x ₄ of the medical device. The user also preferably identifies at least one point between points x ₁ and x ₄ , preferably at least two other points x ₂ and x ₃ . The user can of course identify more points, but the accuracy gained by doing so is not worth the inconvenience to the user.

  Other methods of reconstructing the shape of the tip of the medical device are possible. For example, points can be identified individually on each view. Based on these points, the processor can cause splines for each plane to appear (a series of polynomial curves), and then characterize the shape of the medical device in three dimensions (features). Identify corresponding points on the two splines.

  As shown in FIG. 4A, a point can be identified by manipulating the cursor on each of the two-plane displays (displays) and clicking on a point such as point 100. As shown in FIG. 4B, after the user clicks a point 100 on the LAO, a line 102 is displayed on the RAO, and the identified point 100 in the LAO must be located along that line 102. As shown in FIG. 4C, the user then uniquely identifies a point in the three-dimensional space by identifying the desired point 104 along the line 102 displayed on the RAO. The user can start on the RAO and complete the point identification process in LAO. Several other methods can be used to identify the points, or the points can be automatically identified using, for example, image processing.

  Instead of using two-way images to uniquely identify points on the medical device to characterize the medical device shape, localization is used to characterize the shape of the medical device. It is of course possible to use a (localized) system. For example, a magnetic positioning system uses a reference transmitter in a treatment room to transmit to one or more receivers on a medical device to position the receiver and thus A medical device in three-dimensional space can be positioned (or one or more transmitters on the medical device can be transmitted to a reference receiver in the treatment room). For example, other positioning systems using ultrasound or electrical potential can be used.

Once the points x ₁ , x ₂ , x ₃ and x ₄ in 3D space have been identified, these points can be processed to determine the shape of the tip of the medical device. This process makes it possible to determine whether the point x ₁ is actually a support point and pivot point of the medical device. For example, in a uniform medical device such as a uniform wall catheter, the tip portion of the medical device, ie, the portion at the tip distal to the pivot point, is generally circular. Assume that there is. Thus, whether the selected point x ₁ is actually a support point or a pivot point determines the circularity of the reconstructed curve between points x ₁ , x ₂ , x ₃ and x _4. It can be determined by checking. When using other catheter configurations where the characteristics are not uniform along the length, the effectiveness of x ₁ as a support or pivot point, as opposed to a calculated or empirically determined shape, This can be determined by checking the shape of the part.

In this preferred embodiment, if it is determined that the point x ₁ selected as a temporary pivot point or support point is not a valid pivot point or support point, this is indicated, for example, in a text message or display. By changing the color of that point above it informs the user (signals) and informs the user to select another temporary pivot point or support point. The system can also suggest (suggest) one or more suitable pivot points or support points for simple acceptance by the user with proper processing. Once the pivot point or support point is correctly determined, the processor then determines (determines) the free length l of the medical device that is distal (distal) to the pivot point or support point. )can do.

Pivot or support point x ₁ , free length l, tip length, indicated by the location of points x ₁ , x ₂ , x ₃ and x ₄ identified by the user when a known magnetic field is applied or formed The characteristics can be used to calculate the morphology of the tip portion of the medical device when given a different magnetic field. These calculations can take into account the characteristics of the medical device expressed in a lookup table or one or more equations developed (developed) by mathematical modeling or empirical measurements. These calculations can also take into account the previous (previous) point set x ₁ , x ₂ , x ₃ and x ₄ that the user has identified for the same (or similar) medical device.

  Therefore, even when different magnetic fields are applied, it is possible to display a virtual medical device representation (representation, representation, representation) 106 representing the form (shape and direction) of the actual medical device. (Of course, for other remotely controllable medical devices, the interface is a virtual medical device that represents the form of the actual medical device as if one or more control parameters were selected and changed by the user. May be displayed). This representation is superimposed on the image of the treatment area in panes 92 and 94. Therefore, the user can select the desired new magnetic field and observe the form of the tip of the medical device as if the new magnetic field had been applied before the new magnetic field was applied and appropriate adjustments were made. . Various systems and methods have been devised and proposed to identify the desired direction of a given magnetic field. For example, a user can identify a start point and an end point (eg, on a display of a two-way imaging system) and can provide a magnetic field (field) in a selected direction. As an alternative, the user can manipulate the vector representation of the desired magnetic field direction, or can select the previously used (previous) direction, or the direction associated with the previously identified point (user Can be used with other remotely controllable medical devices to manipulate the appropriate control parameters to change the configuration of the device). However, in any case, the resulting form of the medical device is only a user's guess based on experience. According to the present invention, it is possible to create a display of the form that the distal end of the medical device should take when a desired magnetic field is applied before the magnetic field is actually applied.

  Furthermore, as shown in FIG. 3A, all possible points that the tip of the medical device can reach by only changes to one or more selected control parameters such as the direction and / or strength of the magnetic field are represented. A surface 108 can be generated. In this preferred embodiment, this surface 108 is generally parabolic. This surface 108 can also be displayed, and the user can identify a point on this surface, and the system can provide the correct magnetic field to be applied by the process to bring the tip of the medical device to the selected point. Can be determined. The user can reach a point slightly beyond the surface by aligning the medical device in a desired direction and slightly moving the medical device forward. As shown in FIG. 3B, the system can also generate and display possible point planes 108 ′ and 108 ″ for different free lengths l ′ and l ″, so that the current set of possible points (current If the surface representing the possible points of the set does not reach the desired position, the user can select from the surfaces representing the different sets of possible points (the possible points of the different sets) and manually If the free length l is adjusted or the system is provided with a mechanized advancer mechanism, the system can automatically adjust the free length l.

  The system and method of the present invention also allows the user to change the form of the displayed representation 106 of the medical device and provide a magnetic field to obtain the desired form. Accordingly, the display can be coupled to a control means that changes the form of the displayed virtual image 106 of the distal portion of the medical device. These control means may be control means for changing the deflection (deflection) and rotation of the distal end portion of the medical device, for example. As shown in FIG. 5, these control means are realized by the screen control means 110 and 112 and point to this control means in order to change the degree of deflection and to change the degree of rotation (point operation). And click and drag. These control means 110 and 112 are the same as the control means provided in a device capable of mechanical navigation. In practice, instead of providing the control means on the screen, it can be provided on a catheter handle similar to a normal catheter handle, and the user can manipulate the deflection and rotation of the tip of the medical device. it can. Once the desired excursions and rotations are obtained using the control means 110 and 112, as indicated by the display of the virtual device in the panes 92 and 94, the user can, for example, use virtual buttons to provide a magnetic field. Pointing or clicking 114 (or other control means) can provide the proper magnetic field. As an alternative, the system can also operate in a continuous mode, in which the form of the tip portion of the medical device automatically changes based on changes in the displayed image 106 without the need to operate the button 114. Can be made. The possible forms of the displayed virtual device are preferably limited to those that can be realized by the possible formed magnetic field, so that the user cannot manipulate the virtual device to an infeasible form. Can not. This can be incorporated into the control means as well, thereby preventing the user from manipulating the virtual device image 106 into a physically unrealizable form.

  Just as a processor can determine its form for a given magnetic field, the processor can determine the magnetic field that should be properly formed for a given form. Thus, the user can specify the form, more preferably the target point (target point), and the interface determines the control parameters (eg magnetic field direction, magnetic field strength, free length) to reach the target. Can do. The interface displays the assumed new form, and if it is satisfactory, the user accepts it and is supplied with interface decision control parameters to reach the target.

  The system can store the characteristics of various types of medical devices, and one of these stored values can be used in a mathematical model that determines the shape of the virtual medical device display 106. Let's go. The user can select some of these stored values and, as shown in FIG. 5, pane 96 is a window (indicia) that displays indicia that identifies the stored values used. Windows) 116 may also be included. The pane may also include an indication 118 of the direction of the currently applied magnetic field.

  The interface employs several models of medical devices. In the following description, a model of a simple case (case) of a flexible device having a uniform elastic or elastic property and comprising one permanent magnet placed on the chip of the device is shown. This model and details are for when non-uniform elastic or stretch properties and more than one (two or more) magnets are used, or when another model of device operation is used. It can be generalized in a form that can be determined by experts in this field. The form of the medical device can be expressed mathematically as follows.

The distances between points x ₁ , x ₂ , x ₃ and x ₄ are given by:

The unit tangent vectors ( ^→ n ₁ and ^→ n ₄ ) ( ^→ n represents the vector n) at the points x ₁ and x ₄ are estimated as follows:

The deformation angle θ between x ₁ and x ₂ can be found from cos θ = ^→ n _1. ^→ n ₄ .

Deviation from planarity
Points x ₁ , x ₂ , x ₃ and x ₄ can be checked to ensure that points x ₁ , x ₂ , x ₃ and x ₄ are generally in one plane. The unit vector ^→ p between x ₁ and x ₄ is given by:

Next, the vector ^→ q ₁ orthogonal to ^→ n ₁ and ^→ n ₄ is given by:

Further, the vector ^→ q ₂ orthogonal to ^→ n ₁ and ^→ p is given by the following equation.

^→ The angle φ between q ₁ and ^→ and q _2, measure of flatness of point (planarity) (reference: its measure) in given by the following equation.

  Regarding planarity, it is desirable that φ ≦ 10 ° ≈π / 20.

Circularity check (uniform rigidity)
For a medical device of uniform stiffness, the tip portion is assumed to be generally circular in shape. The selection of points, in particular the pivot point x ₁ , can be effective by ensuring that the points are substantially along a circle (ring, circle). (For non-uniform devices, several other checks are performed on the points). ^→ u represents the direction unit vector of the magnetic field and is defined as ψ = cos ⁻¹ ( ^→ u · ^→ n ₁ ). The delay angle α between a given magnetic field and its direction is given by α≡ (ψ−θ) and is defined as such. If m is the magnetic moment of the magnet on the tip of the medical device and β is its stiffness (β = EI, where E is the Young's modulus of the material and I is the bending moment of that region (location)) The following formula holds:

Here, B is the magnitude of the magnetic (magnetic field) intensity, and l is the length of the medical device between ^→ x ₁ and ^→ x ₄ .

  The chord length is given by:

If the point exists along a circle, the chord length d ′ needs to approach c≡ | ^→ x ₄ − ^→ x ₁ |, and should be within 10%, for example. That is,

  When the above constraints are met, the medical device curve is estimated as follows.

ν is the unit vector in the plane of the medical device that is orthogonal to ^→ n _1.

  The curve of the medical device is represented by the following formula:

  The envelope or surface of the chip when the direction of the magnetic field changes is determined based on the following equation for the position of the chip.

By changing θ from 0 to θ _mas (= lMB / β), an envelope (envelope surface) or locus of the position of the chip when the magnetic field changes is given.

Once the decision point Z for the direction of the magnetic field relative to the selected point is selected on the envelope (envelope surface), the direction of the magnetic field that brings the chip to that position may be calculated according to the following equation:

  Here, the direction of the corresponding magnetic field for directing the chip in the direction of the point Z is given by the following unit vector.

"Accessible surface (accessible Surface)" is also, the above formula envelope obtained by [25] (the envelope surface) is defined by rotating the ^→ n ₁ as a pivot, ^→ v and ^→ n ₁ unit vector ^→ w orthogonal to the ^→ w = ^→ v given by × ^→ n _1, rotation ^→ v of ^→ w to the center of rotation ^→ n ₁ is
Against
Given by.

The above formula [26], by changing the direction of the magnetic field by changing the θ and xi], define a surface of revolution accessible to the chip, a ^→ n ₁ as a rotation center, face, longitude And a sphere with latitude.

Similar to the generation formula [25] of the direction of the magnetic field for an arbitrary point on the surface, given a desired point on this surface ^→ z, the corresponding magnetic field is obtained from the following equation [16].

Here, ^→ v _RS is obtained from the following equation.

here,
It is.

When the position of the desired chip exceeds the accessible surfaces, combinations of the inserted length of the change and the magnetic field direction, to move toward the distal end of the medical device from the current position ^→ z I need it.

As described above, ^→ u ₁ Defines, phi ^- and theta ^- find (phi ^- represents phi bar or phi dash). l ^- is the new medical device length, and
Then,

become.

  Given equations [28] and [29],

and
Is a change in the inserted length that brings the end of the medical device in a predetermined direction along with a change in the direction of the magnetic field.

  Although described herein in the context of a magnetic surgical system, as noted above, the virtual device interface of the present invention is mechanically, hydraulically or by magnetostrictive and electrostrictive means. Needless to say, the present invention can be applied to other devices capable of controlling the form of the medical device including the device to be controlled.

  A second embodiment of the user interface is shown in FIG. The interface of the second embodiment controls a magnetic navigation system that provides a magnetic field to the treatment area (surgical area) in the patient for the user to control the orientation of the magnetic medical device in the treatment area (surgical area). It is adapted to help you. An advance / retractor mechanism is preferably provided for controlled advance / retreat of the medical device. As shown in FIG. 10, the user is given several virtual or actual buttons, and the user is given a mouse, a track ball, a space ball, a joy stick, It can be operated using a tablet or other input device. An operation button 200 initiates navigation according to the present invention, a window (or other message) is displayed, and a number on the medical device on the display 202, including an image 203 of the medical device that includes an anchor point. In order to identify the points, the user is prompted (instructed) to use the input device.

  The user identifies the point, for example, by placing the cursor on the medical device on the display 202. In this preferred embodiment, the inventor has determined that four points are appropriate from the balance between the user effort (effort) and the accuracy of the characterization of the medical device being navigated, but otherwise A number of can also be used. The identified point is checked (as described above) or considered valid (qualified) and the window (or other message) properly identifies one or more points to the user. Call attention to whether it is not.

  Using information about the magnetic field currently provided and the position and morphology of the medical device (obtained from the identification of the points), the processor implementing the interface can characterize the medical device. The user can then operate the direction control button using the input device. In this preferred embodiment, there are four buttons, such as buttons 204 and 206 for increasing or decreasing the deflection of the medical device and buttons 208 and 210 for rotating the medical device. The interface can be operated in discrete navigation mode, continuous navigation mode, or the interface allows the user to switch between individual navigation and continuous navigation. In a separate navigation mode, the user clicks on button 204, 206, 208 or 210 and an image 212 of the virtual device is superimposed on the display 202 showing the form of the medical device with the given new magnetic field given. The As represented by the virtual device image 212, once the user is satisfied with the new magnetic field, the user operates a control means (such as a button) to activate the magnetic navigation system and the specified magnetic field. In such a way that the actual medical device substantially takes (follows) the form and position represented by the image 212 of the virtual device. In the continuous navigation mode, the user can operate in the continuous navigation mode, and the change of direction specified by operating the buttons 204, 206, 208 and 210 is automatically performed to move the medical device. The user can enter continuous navigation mode, for example by pressing down a control button. Buttons 204, 206, 208 and 210 are preferably operable to change the deflection (deflection) and rotation, preferably by a pre-set individual amount, and can be customized by the user, or the deflection and rotation can be navigated. It is preferable to be able to press down to continuously change to the limit value of the system. In addition to controlling the rotation and deflection of the medical device separately, many other mappings are possible. For example, the device chip can be properly controlled or actuated to move within a selected plane.

  In another embodiment, a joystick can be provided for interactive device control. In this case, the user selects from a set of possible mappings depending on the joystick's deflection (deflection) to changes in the actuation control variable that changes (changes) the form of the medical device. In one special case where a magnetic surgical system is used for device operation, the magnetic field is controlled (driven) by a joystick. Visible feedback from the imaging system that can employ X-ray, magnetic resonance imaging, ultrasound, or other imaging modalities well known to experts in the field, provides the device configuration to the user Thereby, the medical device may be interactively driven by the user to reach the desired target. In other embodiments, various other input devices may be used for interactive remote control over device operation, including space balls or custom made devices.

  The interface also allows the user to click on the point being displayed to mark (mark) the target point 214 on the two-dimensional display. The interface then provides the magnetic navigation system and the magnetic field required to stretch or retract the medical device (preferably controlled by an automated advance / retract system) required to reach the target point 214. The virtual device image 216 is displayed with the determined and calculated magnetic field and with the proper adjustment of the length performed. The user then operates a control means (such as a button), thereby adjusting the calculated magnetic field and length. As an alternative, the user can be operated in a continuous navigation mode (eg by pressing another button on the joystick) so that the magnetic field formed thereby and the length of the device can be Is automatically changed to go to the identified point 214 by clicking on the display 202.

  Since the user attempts to identify a point in 3D space by identifying a point on the 2D display, the tip of the medical device may not exactly match the location intended by the user. The user can switch to a different display in order to more finely distinguish the position (if a bi-directional image of the treatment area is available). Alternatively, if two-way imaging or two corresponding images can be used, the user can identify a target point (target point) on each image and uniquely identify the point in 3D space Can be identified. After the user identifies a target in one image, the interface assists in selecting an appropriate point in the second image. For example, the color or shape of the cursor can indicate that it is when the cursor is over a valid or invalid position based on user selections on other displays. In individual navigation, when the user actuates an “apply field button”, the magnetic navigation system will reach the specified target point (secure the target point). Provide the necessary magnetic field. In one embodiment of the continuous navigation system, the magnetic navigation system generates the magnetic field necessary to reach the specified target point as soon as the target point is properly specified (to ensure the target point). Automatically starts. In order to prevent unintentional movement, the user should preferably press the button to maintain continuous navigation mode, and releasing the button causes the magnetic navigation system to stop moving. In one embodiment employing a joystick, for example, the button may be a trigger button on the joystick. In practice, the “apply field button” used in the individual navigation mode and the “continuous navigation button” used in the continuous navigation mode may be the same.

  As an alternative, the user can make fine adjustments to the position using buttons 204, 206, 208 and 210. Once the medical device is characterized according to instructions by the interface system, the system automatically interprets the user pointing and clicking on the display 202 as an indication that the target point 214 is being identified. be able to. Alternatively, a button may be provided on the display or on the input device for the user to turn on the target mode.

  As described above, the user can input a change in direction using a joystick instead of the buttons 204, 206, 208 and 210. For example, the deflection can be increased or decreased by moving the joystick back and forth, and rotation can be caused by moving the joystick left or right (or by twisting the joystick). Similarly, other modes of mapping from joystick to device operation can be used. The user can operate in individual or continuous mode using the buttons described above. When operating in the individual mode, the user uses the joystick to position the virtual image 212 on the display 202 and, if that position is acceptable, operates the control means (such as a button on the joystick). Make the navigation system provide a magnetic field. When operating in continuous mode, the user operates the control means (eg, presses a button on the joystick), and the change indicated by the movement of the joystick is automatically performed, and the magnetic navigation system responds accordingly. To change the required magnetic field. In this mode, when the user operates the joystick, the medical device responds interactively.

  In a preferred embodiment, the advancement of the medical device is preferably controlled separately by the user, for example using a toggle switch on the joystick, so that both maneuvering the device and advancing or retreating the device. One joystick can be used, or a separate button on display 202 can be used. However, in target mode, the interface preferably controls both the magnetic navigation system and the advancer system, so the medical device is directly computer controlled. In a further preferred embodiment, the advancement of the medical device and the deflection or shape change of the medical device are controlled by the user with separate joysticks. Various other embodiments and modes of use can be envisioned by those skilled in the art.

  FIG. 11 shows a display 300 from another implementation of the interface system of the second embodiment. The display 300 includes two bi-directional images 302 and 304 of the treatment area (surgical area). The display also includes a control pane 306. In box 308, which can be included in the control pane, the user can select or specify the stiffness of the medical device. As an alternative, the type of medical device can be selected from a menu of medical devices whose stiffness values are pre-programmed into the system. The computer processor uses the stiffness to determine the form of the medical device in the forming magnetic field, generates a virtual image of the medical device under the specified magnetic field, and generates the forming magnetic field to reach a specific target point. Can be calculated.

  The control pane 306 also includes a field display 309 having coordinates of the current magnetic field direction and a pick box for selecting a magnetic field formation point. The control pane has a free length box 310 to allow the user to select a free length from the end of the medical device sheath. Arrows 312 and 314 allow the user to perform a specified length increase or decrease performed by the advance / retract mechanism (advancer / retractor mechanism). The control pane 306 also includes sliding control means 316 for controlling the degree of deflection and rotation (such as buttons 204, 206, 208 and 210). An apply field button 320 allows the user to create a magnetic field specified by the virtual device being displayed. A conform to field button 322 causes the virtual device model to predict and display the shape that would result from the formation of the input magnetic field. A get live button 324 updates the images 302 and 304. Finally, a target mode button 326 allows the user to enter target mode (as described above), thereby virtualizing by pointing and clicking on the displays 302 and 304. Identify the point where the medical device moves in the individual mode, or identify the point where the actual medical device moves in the continuous mode.

In yet another embodiment of a user interface according to the principles of the present invention, user interaction can be further simplified for ease of use. In FIG. 12, graphical buttons 411 and 412 are provided as alternative controller modes of the magnetic navigation system. Button 411, when selected, is indicated by a direction designation in two projections, typically LAO and RAO perspectives or perspectives well known to intervening surgeons. The direction of the magnetic field can be defined in the dimensional space. When a corresponding magnetic field is formed to steer a medical device, the medical device tends to align itself with the magnetic field, but is determined by the elasticity (flexibility) and magnetic properties of the medical device With a certain amount of angular delay. On the other hand, the button 412 can directly select a target position to which the medical device can move. To use this mode, the user first selects the “Mark catheter base” button 413 (highlighted in FIG. 12) by mouse click. This allows the user to draw (using a pen tablet) the pivot point or support point of the medical device, as well as the direction of rotation, by drawing the line appropriately in the two projected X-ray views. Or by dragging the mouse appropriately). In FIG. 12, it can be observed that the catheter 419 extends from the guide sheath 422. A line 420 drawn by the user indicates that the pivot point is the distal tip of the sheath and the direction in which the medical device 419 extends at the pivot point. FIG. 13 shows pivot points and directions marked by lines 505 and 506 on RAO and LAO screens 501 and 502. This process effectively gives x _l and n _l to the system. Next, the user selects the target button 412 as shown in FIG. This gives the user a “target” cursor 601 that allows the user to select a point 602 in the three-dimensional space from the two X-ray projections. This point is the desired anatomical target point that the user wishes to steer the medical device. The computer then calculates the required magnetic field direction and insertion length from equations [25] and [32]. The corresponding shape of the medical device is also calculated and displayed as a dashed curve 603. FIG. 15 shows the desired target points in the RAO and LAO projections as 602 and 602a, respectively, and the associated projections of the respective device shapes 603 and 603a11.

  When the button is pressed, the required magnetic field direction and insertion length need only be automatically provided by the system. Alternatively, the direction of the magnetic field may be provided directly by the system while the user is continuously controlling the advancement or retraction of the medical device. The medical device curve is updated to show as a solid line, perhaps as a solid line of a different color, indicating that the desired change in control information has occurred. FIG. 16 shows an LAO perspective of such an updated device curve 650 with a user-specified pivot direction 648 and a desired target position 652. Furthermore, the device shape can be interactively operated by the user as described above. In one convenient implementation, keyboard buttons are used to increase or decrease the deflection of the virtual device and to rotate the virtual device clockwise or counterclockwise about the pivot direction. To do. The shape of the device is continuously calculated and updated in the projected display, and possibly (possibly) updated during the three-dimensional display during this user adjustment process. A corresponding manipulated virtual device 702 is shown in the LAO perspective of FIG. 17, which includes the current device configuration 701 and an updated device chip when the user manipulates the virtual device. Position 703 is shown together. Once the desired device shape or chip position is obtained, the corresponding control is given by touching the “Apply” button, or alternatively, the system is specified by the user each time the keyboard button is pressed. Control information (in one embodiment, magnetic field and insertion / retraction) is provided in the steps that are performed. Another convenient implementation of continuous control uses a joystick or other input device with a mapping function. The mapping function converts joystick movement into control input changes, thereby causing the medical device to continuously respond to joystick movement. In one implementation, the user would be able to cause a change in the control input to be delivered by moving or deviating the joystick and pressing and holding the “trigger” button. The user observes the device's response to joystick movement (on X-ray images or other visualization modes) and releases the “trigger” button on the joystick, for example, when the desired device configuration is obtained May interactively stop the response of the device.

  The actuation system employed to steer or orient the flexible device is a magnetic actuation using an external magnetic field, a mechanical cable using a steering cable or force transmission element (transmission element) provided within the device. Actuation, actuation of a device using an electrostrictive polymer such as a piezoelectric material or silicone elastomer, actuation using a magnetostrictive element incorporated in the device, or other techniques well known to those skilled in the art , Can take several different forms.

  In a preferred embodiment, a magnetic field generated by an external magnet can be used to orient the magnet incorporated in the tip portion of the device. By controlling the externally applied magnetic field, the interaction between the external magnetic field and the magnet of the device acts to orient the device in a controllable manner. The external magnet can be either a permanent magnet or an electromagnet, and in some cases a superconductor could be used to generate a strong magnetic field. FIG. 1 shows a schematic diagram of such a system and apparatus.

  In an alternative preferred embodiment employing electrostrictive actuation, the device could use an electrostrictive material that is electrically energized to bend or steer the device. . FIG. 18 shows a flexible device 851 incorporating electrostrictive elements 854 and 855. Electrical leads 858, 859 and 865, 866 connect elements 854 and 855 to voltage source 856, respectively. The electrostrictive element 854 is disposed (sandwiched) between the rings 860 and 862. When a voltage is applied between the leads 858 and 859, the length of the electrostrictive element 854 decreases, and the flexible device is defined by the surface of the device and the direction of the electrostrictive element relative to this axis. Force bending inside. The amount of bending can be controlled by changing the applied voltage. When a voltage is applied between leads 855 and 866, electrostrictive element 855 is shortened, causing the device to bend in the opposite direction.

  In some cases, it may be useful to determine the curved surface of the device. This is important when a non-magnetic steering mechanism is used to orient the device. This may be performed by employing an imaging method such as X-ray imaging or by employing a localization sensor embedded in the device. If a positioning sensor is used that gives the complete position and orientation of the device, the direction of the actuation (starting) mechanism, such as a steering cable or electrostrictive element, is known in the reference (reference) configuration (configuration); The corresponding direction in the general form may be obtained by processing the data obtained from the positioning sensor. Therefore, the curved surface of the device in the three-dimensional space may be determined. As an alternative configuration, an imaging method such as X-ray (fluoroscopy) may record the change in tangent vector relative to the device chip when a small change in actuation control variable occurs, This provides the information necessary to determine the curved surface in the three-dimensional space.

  With knowledge of the curved surface, the device can be controlled for targeting and for changing the form with the help of a computational model in a manner similar to that described above.

  The embodiments described herein are given by way of example only and may be used to maneuver the device using other embodiments of an actuation system such as, for example, a mechanical actuation device or other actuation device well known in the art. it can. In the following description, a computational model for magnetic actuation using an externally applied magnetic field will be described as a non-limiting example, but the computational model and its usage are generally different possible actuation systems. It should be understood that can be incorporated.

  The coordinates of the actuation system may be recorded in the coordinates of the imaging system and the coordinates of the positioning system by several methods known to those skilled in the art. For example, the actuation system may employ an external magnetic field, in which case a magnetic field source, such as an external magnet, is used by the imaging system by using properly placed markers located at known locations with respect to the actuation system. Could be recorded (registered) mechanically. Since information from multiple image projections or 3D imaging is available from the imaging system, each of the above locations may be an assigned coordinate in the reference frame of the imaging system. The positions of the three markers determined in both coordinate systems are sufficient to produce a fixed (rigid) coordinate transformation (rotation and translation), which is an essential record (registration). . Additional markers may be used to improve accuracy as needed.

  Similarly, if the positioning system of the device is used, it can also be used to determine the coordinates of a known marker for this positioning system, thereby allowing the various distinct coordinate frames used in the various systems. Mutual records (registration) can be provided. In practice, such recording (registration) is performed at the start of the medical procedure. Subsequent movements of the patient table may be tracked within reasonable accuracy to allow for updated recording (registration) that may be required based on standard criteria during the clinical procedure.

  In the foregoing description, the magnetic actuation system has been described as a non-limiting example, but various alternative actuation systems may be arranged and recorded (registered) as needed according to the methods described herein. For example, an apparatus using a piezoelectric actuator may use a coordinate frame that is common to an X-ray imaging system that only requires recording (registration) in the apparatus positioning system. Similarly, the marker in question may be mechanically placed by the user or based on an anatomical location pinpointed (exactly indicated) by the user. May be.

FIG. 1 is a schematic perspective view of a magnetic surgical system incorporating the interface system of the present invention. FIG. 2 is a schematic diagram of a possible display screen for implementing an interface system for a magnetic surgical system constructed in accordance with the principles of a preferred embodiment of the present invention. FIG. 3A is an enlarged view of one of the two-way image displays from the interface shown in FIG. 2, showing a possible position plane for the tip portion of the medical device. 3B is an enlarged view of one of the two-way image displays from the interface shown in FIG. 2, showing a possible position plane for the tip portion of the medical device for different free lengths l. FIG. 4A is a schematic diagram of a two-way image display from the interface shown in FIG. 2, showing point identification. FIG. 4B is a schematic diagram of a two-way image display from the interface shown in FIG. 2, showing point identification. FIG. 4C is a schematic diagram of a two-way image display from the interface shown in FIG. 2, showing point identification. FIG. 5 is an enlarged view of the control panel for the interface shown in FIG. FIG. 6 is a graph showing that a fixed length tip of the medical device can contact in-plane. FIG. 7 is a diagram representing the distal portion of the medical device showing points x ₁ , x ₂ , x ₃ and x ₄ . FIG. 8 is a diagram illustrating the relationship between the direction vector and the magnetic field vector. Figure 9 is a diagram showing the relationship between the direction vector and the unit vector ^→ w orthogonal to ^→ v and ^→ n _1. FIG. 10 is a representation of another display for the second embodiment of the user interface that selectively uses the display of the virtual medical device. FIG. 11 is a diagram representing another display for the second embodiment of the user interface that selectively uses the display of the virtual medical device. FIG. 12 is a diagram showing a display from a third embodiment of a user interface with screen buttons. FIG. 13 is a diagram representing LAO and RAO images from the third embodiment of the user interface. FIG. 14 is a diagram representing a RAO image of the third embodiment of the user interface in target mode, showing the target cursor, target, and virtual device. FIG. 15 is a diagram representing LAO and RAO images from a third embodiment of the user interface in target mode, showing a virtual device extending to the selected target. FIG. 16 is a diagram representing a LAO image of the third embodiment of the user interface showing the virtual device after the control has changed. FIG. 17 is a diagram representing an LAO image of a third embodiment of the user interface showing further changes in the virtual device after previous changes have occurred in the control information. FIG. 18 is a side view of a medical device constructed according to the principles of the present invention and adapted for control according to various embodiments of the present invention.

Claims (61)

A method of operating a navigation system for remotely placing a distal portion of a medical device within a target object, comprising:
Displaying a virtual representation of at least a portion of the medical device based on a computational model of the medical device;
Receiving input information made by a user to change the form of the portion of the medical device represented by the displayed virtual representation, and updating the virtual representation of the portion of the medical device;
Manipulating the navigation system with the computational model of the medical device to adapt the portion of the medical device to a desired form represented by the updated virtual representation;
A method characterized by.   The method according to claim 1, wherein the user creates input information away from the target object.   The medical device is an elongated medical device having a proximal end portion outside the target object and a distal end portion in the target object, and the virtual representation relates to at least the distal end portion of the medical device; The method of claim 1, wherein the navigation system changes a form of at least the tip portion of the medical device.   4. The step of displaying a virtual representation of the tip portion of the elongate medical device includes superimposing a representation of the tip portion of the elongate medical device with a representation of a treatment area in the target object. The method described.   The method of claim 4, wherein a representation of a treatment area within a patient's body is obtained from an x-ray image.   The method of claim 4, wherein a representation of a treatment area within the target object is obtained from a CT image.   The method of claim 4, wherein a representation of a treatment area within the target object is obtained from an MR image.   The method of claim 4, wherein a representation of a treatment area within the target object is obtained from an ultrasound image.   The method of claim 4, wherein a representation of a treatment area within the target object is obtained from a map of points on a surface of the treatment area.   The navigation system operates in response to a control variable and receives input information made by a user to change the shape of the tip portion of the elongate medical device represented by the displayed virtual representation. Receiving a desired change to a control variable of the navigation system corresponding to a desired change in an operating state of the navigation system; and a virtual representation of the tip portion of the elongate medical device as if the navigation system Updating the medical device to make it appear as if the control variable has actually changed.   The navigation system includes at least one external magnet that provides a magnetic field to a magnetic response element provided on the medical device, the system receiving input information regarding a desired change in the direction of the magnetic field. 10. The method according to 10.   Receiving input information made by a user to change the shape of the tip portion of the elongate medical device represented by the displayed virtual representation is input regarding a new orientation of the tip portion of the elongate medical device The method of claim 3, comprising receiving information.   Receiving input information made by a user to change the shape of the tip portion of the elongate medical device represented by the displayed virtual representation comprises: 4. The method of claim 3, comprising receiving input information relating to deviations from the form.   Receiving input information made by a user to change the shape of the tip portion of the elongate medical device represented by the displayed virtual representation relates to a new position relative to the tip portion of the elongate medical device. The method of claim 3, comprising receiving input information.   The method of claim 3, wherein the navigation system includes an element within the medical device that, when operated, changes a form of the tip portion of the medical device.   16. The method of claim 15, wherein at least some of the elements that change the shape of the tip portion of the medical device are electrostrictive elements.   16. The method of claim 15, wherein at least some of the elements that change the shape of the tip portion of the medical device are magnetostrictive elements.   The method according to claim 17, further comprising applying a magnetic field from an external source magnet to the magnetostrictive element to change the shape of the tip portion of the medical device.   4. The method of claim 3, wherein the navigation system includes a mechanical link in the medical device that, when moved, changes a shape of the tip portion of the medical device.   4. The method of claim 3, wherein the step of operating the navigation system occurs automatically after input information by the user is received.   The method of claim 3, wherein operating the navigation system occurs only after input by the user.   The method of claim 3, wherein the computational model is based at least in part on physical characteristics of the medical device.   The method of claim 3, wherein the computational model is based at least in part on a mathematical representation of at least one physical characteristic of the medical device.   The method of claim 3, wherein the computational model is based at least in part on a measurement of at least one physical property of the medical device. The position of the tip portion of the medical device is controlled by an advance and retract mechanism;
Further receiving input information made by the user to change the position of the tip portion of the medical device, updating a virtual representation of the tip of the elongate medical device;
4. The method of claim 3, wherein the advance and retract mechanisms are operated to adapt the tip portion of the elongate medical device to a desired position represented by the updated virtual representation.   Determining the actual position and configuration of the tip portion of the medical device and comparing the actual position and configuration of the tip portion of the medical device with the position and configuration given by the calculation model, by means of calculating means by the medical device; 4. The method of claim 3, wherein the contact force between the tissue and the tissue in the treatment area is determined. A method of operating a navigation system that remotely positions a distal portion of a flexible medical device within a target object to reach a target comprising:
Display the treatment area representation,
Receiving input information relating to a form of the part of the medical device, displaying a representation of the form of the part;
Receiving input information about a target on the display of the treatment area;
Based on a computational model of the medical device and navigation system, determining input information necessary for the navigation system to cause the medical device to reach the goal;
Providing the determined input information to the navigation system to cause the medical device to reach the goal;
A method characterized by.   28. The method of claim 27, wherein the medical device is an elongate medical device having a proximal end outside the target object and a distal end within the target object.   29. The method of claim 28, wherein the navigation system is capable of changing a shape of the tip portion of the medical device and advancing and retracting the tip of the elongate medical device.   The navigation system includes at least one magnet that provides a magnetic field in a selected direction to a magnetic response element in the medical device, and targets the elongate medical device based on a computational model of the elongate medical device. Determining the input information required for the navigation system to reach, the navigation system determining, based on the computational model, the direction of the magnetic field required to bring the medical device to the target. 30. The method of claim 28, wherein:   In order to cause the elongate medical device to reach a goal based on the computational model of the elongate medical device, the input information required for the navigation system is determined, and the navigation system targets the medical device based on the computational model. 31. The method of claim 30, comprising determining the magnetic field strength required to reach   The method of claim 30, wherein the user creates input information away from the object.   31. Displaying a virtual representation of the tip portion of the elongate medical device includes superimposing a representation of the tip portion of the elongate medical device with a representation of the treatment area in the target object. The method described in 1.   34. The method of claim 33, wherein a representation of the treatment area within the target object is obtained from an x-ray image.   34. The method of claim 33, wherein a representation of the treatment area within the target object is obtained from a CT image.   34. The method of claim 33, wherein a representation of a treatment area within the target object is obtained from an MR image.   34. The method of claim 33, wherein a representation of a treatment area within the target object is obtained from an ultrasound image.   34. The method of claim 33, wherein a representation of a treatment area within the target object is obtained from a map of points on the surface of the treatment area.   28. The method of claim 27, wherein the navigation system includes at least one external magnet that provides a magnetic field to a magnetic response element of an elongated medical device, and the control input information includes a change in direction of the magnetic field.   28. The method of claim 27, wherein the navigation system includes elements within the medical device that change the shape of the tip portion of the medical device when operated by the navigation system.   41. The method of claim 40, wherein at least some of the elements that alter the shape of the tip portion of the medical device are electrostrictive elements.   41. The method of claim 40, wherein at least some of the elements that alter the shape of the tip portion of the medical device are magnetostrictive elements.   41. The method of claim 40, wherein the navigation system includes a mechanical link in the medical device that changes the shape of the tip portion of the medical device when moved.   28. The method of claim 27, wherein the step of operating the navigation system occurs automatically after user input information is received.   28. The method of claim 27, wherein operating the navigation system occurs only after input by a user.   28. The method of claim 27, wherein the computational model is based at least in part on physical characteristics of the medical device.   47. The method of claim 46, wherein the computational model is based at least in part on a mathematical representation of at least one physical characteristic of the medical device.   47. The method of claim 46, wherein the computational model is based at least in part on a measurement of at least one physical property of the medical device. A method of navigating the tip of a medical device having a magnetic response element by applying a magnetic field from an external source magnet,
Receive input information about the desired magnetic field from the user,
Display a virtual representation of the form of the tip of the medical device as if a desired magnetic field was applied,
Receiving instructions from the user to provide the desired magnetic field;
A method characterized by. A method of navigating the tip of a medical device having a magnetic response element by applying a magnetic field from an external source magnet,
Identifying a plurality of points on an image of the tip of the medical device while a known magnetic field is applied to the tip of the medical device;
Processing the identified points to determine at least one geometric feature of the tip of the medical device;
Allow the user to input the desired magnetic field,
Display a virtual representation of the tip of the medical device as if it had been given the desired magnetic field,
Allowing the user to input a command to apply the desired magnetic field and direct the medical device in a new direction;
A method characterized by. A method for navigating a distal end of a flexible medical device having an actuation element that is controlled by applying a set of actuation control information comprising:
Display a virtual representation of the tip of the medical device,
In response to input information regarding desired changes in the shape and orientation of the tip of the medical device that can be affected by changing the applied actuation control information, the device characteristics and computational physics for device deformation Updating the displayed virtual representation of the tip portion of the medical device with a model based on
Applying a set of actuation control information based on characteristics of the tip portion of the medical device that places the tip portion of the medical device in a desired shape and orientation in response to input information by a user;
A method characterized by. A method for specifying a set of actuation control information applied to a set of remotely actuated elements at a distal end of a flexible medical device in a patient treatment area, the method comprising:
Identify the point at the tip of the medical device on the image of the treatment area,
Based on information about the tip of the medical device from the identified point, a reconstructed virtual image of the medical device that can be computed as if a new magnetic field was applied to the medical device To display
Receiving input information from a user for changing the form of the virtual image of the medical device;
Applying actuation control information for operating an actual medical device in a treatment area, calculated from a combination of user-specified input information and device physics calculation model, corresponding to a virtual image processed by the user;
A method characterized by. A method for specifying a set of actuation control information applied to a set of remotely actuated elements at a distal end of a flexible medical device in a patient treatment area, the method comprising:
Identify the point on the tip of the medical device on the image of the treatment area,
Based on information about the tip of the medical device from the identified point, a reconstructed virtual image of the medical device that can be computed as if a new magnetic field was applied to the medical device. Display
Receiving input information from the user identifying a target position on the image of the treatment area that the user wishes to reach the device tip;
Apply operation control information for operating an actual medical device in the treatment area, calculated from a combination of user-specified input information and a physical calculation model of the device, corresponding to the chip location specified by the user thing,
A method characterized by. A method for specifying a set of actuation control information applied to a set of remotely actuated elements at a distal end of a flexible medical device in a patient treatment area, comprising:
Using device positioning data at one or more points on the medical device to reconfigure the current device configuration;
Displaying a reconstructed virtual image of the medical device that can be computed as if a set of new actuation control information had been applied to the medical device;
Receiving input information from a user to change the form of the virtual image of the medical device;
Apply operation control information for operating an actual medical device in the treatment area calculated from a combination of input information specified by the user and a device physical calculation model corresponding to a virtual image processed by the user thing,
A method characterized by. A method for specifying a set of actuation control information applied to a set of remotely actuated elements at a distal end of a flexible medical device comprising:
Using device positioning data at one or more points on the medical device to reconfigure the current device configuration;
Displaying a reconstructed virtual image of the medical device that can be computed as if a set of new actuation control information had been applied to the medical device;
Receiving input information from the user to identify the location of the target on the display that the user wishes to reach the device chip;
Apply operation control information for operating an actual medical device in the treatment area, calculated from a combination of user-specified input information and a device physical calculation model corresponding to the user-specified chip position. thing,
A method characterized by. A method for navigating a distal end of a flexible medical device having a set of remotely actuated elements by application of a remote set of actuation control information comprising:
Identifying a plurality of points on two projection images of the tip portion of the medical device while a known (or zero) set of actuation control information is applied to the tip portion of the medical device;
Identifying a desired position of the medical device chip on one or both sides of the projection image of the medical device and its operating environment, or on a three-dimensional local electrical map or projection thereof;
Performing computer calculations based on the elastic or magnetic properties of the medical device, (a) a trajectory of possible positions of the medical device chip in the plane of the tip device chip, shown on one or both surfaces of the projection image; b) an accessible surface at a possible location that can be accessed by the device chip by a combination of deflection and axial rotation, shown on one or both surfaces of the projected image, (c) the device chip in the three-dimensional graphic diagram Performing one or more automatic drafting of the trajectory or accessible surface, generated with
Identifying the desired location of the medical device chip as the locus or point on the accessible surface, either in an image plane, a three-dimensional graphic diagram, or a local electrical activity map;
Performing a set of actuation control information and device advance / retract calculations that allow the medical device to approach and reach the desired tip position;
Using a computer controlled device advancer to control the advancement and retraction of the medical device;
Instructing the computer to automatically advance the medical device toward the selected point by providing appropriate actuation control information and device advancer movement;
Displaying one or more of (a) a new set of projection images of the medical device and its operating environment, or (b) a new three-dimensional local electrical map or projection thereof;
A method characterized by. A method for navigating a distal end of a flexible medical device having a set of remotely actuated elements by application of a set of actuation control information comprising:
Identifying a plurality of points on two projection images of the tip portion of the medical device while a known (or zero) set of actuation control information is applied to the tip portion of the medical device;
Identifying a desired position of the medical device chip on one or both sides of the projection image of the medical device and its operating environment, or on a three-dimensional local electrical map or projection thereof;
A computer calculation based on the elastic or magnetic properties of the medical device, and (a) a trajectory of possible positions of the tip of the medical device in the plane of the tip device tip shown on one or both sides of the bi-directional image (B) an accessible surface at a possible location that can be accessed by the device chip by a combination of deflection and axial rotation, shown on one or both surfaces of the projected image, (c) in a three-dimensional graphic diagram Performing one or more automatic drafting of the trajectory or accessible surface generated with the device chip at
Identifying the desired location of the medical device chip as a point beyond the trajectory or the accessible surface, either in an image plane, a three-dimensional graphic diagram, or a local electrical activity map;
Performing a set of actuation control information and device advance / retract calculations that allow the medical device to approach and reach the desired tip position;
Using a computer controlled device advancer to control the advancement and retraction of the medical device;
Instructing the computer to automatically advance the medical device toward the selected point by providing appropriate actuation control information and device advancer movement;
Displaying one or more of (a) a new set of projection images of the medical device and its operating environment, or (b) a new three-dimensional local electrical map or projection thereof;
A method characterized by. The tip of the magnetically guideable catheter, in which the tip of the tip can be oriented by the applied magnetic field and the free length from the tip of the guide sheath is telescopically adjustable, can be A method of navigating to a selected point in a treatment area within
Using the calculation model of the catheter and information on the position and direction of the distal end of the guide sheath, the magnetic field to be applied is determined so that the distal tip reaches the target point, and the free length for extending the catheter from the guide sheath is determined. A method characterized by:   59. The method of claim 58, further comprising displaying the virtual image of the catheter as if the determined magnetic field was applied to the tip and the catheter was extended to the determined free length.   60. The method of claim 59, further comprising applying the determined magnetic field to the tip and extending the catheter from the guiding sheath to the determined free length. A steerable catheter that allows the tip tip to be oriented according to the applied control variable, and that the free length from the distal end of the guide sheath to a selected point in the treatment area of the object can be telescopically adjusted. A method for navigating the tip of
Using a calculation model of the catheter and information on the position and direction of the distal end of the guiding sheath, a control variable to be applied is determined so that the distal tip reaches the target point, and the free length for extending the catheter from the guiding sheath Determining a method.