US20060025679A1

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Publication number: US20060025679A1
Application number: US11/146,430
Authority: US
Inventors: Raju Viswanathan; Walter Blume; Jeffrey Garibaldi; John Rauch
Original assignee: Individual
Current assignee: Stereotaxis Inc
Priority date: 2004-06-04
Filing date: 2005-06-06
Publication date: 2006-02-02
Also published as: WO2005119505A3; US20060041179A1; US20060041181A1; US20060036125A1; US7540288B2; WO2005119505A2; US20060041178A1; US7516416B2; EP1769390B1; US7543239B2; US20060041180A1; US7540866B2; EP1769390A4; EP1769390A2

Abstract

An interface for remotely controlling a medical device in a patient's body provides a two dimensional display of a three dimensional rendering of the operating region, and allows the user to select the orientation or location of the distal end of the medical device on the display and then operate a navigation system to cause the distal end of the medical device to approximately assume the selected orientation or location.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Application Ser. No. 60/576,946, filed Jun. 4, 2004, incorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to the remote navigation of medical devices in a patient's body, and in particular to a user interface for controlling a remote navigation system.

Advances in technology have resulted in systems that allow a physician or other medical professional to remotely control the orientation of the distal of a medical device. It is now fairly routine steer the distal end of a medical device inside a patient's body by manipulating controls on the proximal end of the medical device. Recently magnetic navigation systems have been developed that allow a physician to orient the distal end of a medical device using the field of an external source magnet. Other systems have been discussed for the automated remote orientation of the distal end of a medical device, for example by operating magnetostrictive or electrostrictive elements incorporated into the medical device. However the medical device is oriented, it is still difficult for a physician to visualize the procedure site (which is out of view inside the patient's body), to selected the desired direction in which to orient the distal end of the medical device and communicate the selected direction to the system in order to orient the distal end of the medical device in the selected direction.

SUMMARY OF THE INVENTION

The present invention relates to an interface to facilitate the selection of the desired direction in which to orient the distal end of the medical device and to communicate the selected direction to a navigation system in order to orient the distal end of the medical device in the selected direction. While the present invention is described primarily in connection with a magnetic navigation system, the invention is not so limited, and can be used in connection with other navigation systems, such as those that can orient the distal end of a medical device with mechanical means, electrostrictive elements, magnetostrictive elements, or otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an interface system according to the principles of this invention;

FIG. 2 is a schematic diagram of a possible implementation of the interface for use in controlling a magnetic surgery system;

FIG. 3 is a schematic diagram of the display of a first preferred embodiment of the interface of this invention;

FIG. 4A is a view of the display of the first preferred embodiment of the interface of this invention, showing several points on the 3-D display pane and the desired orientation arrow;

FIG. 4B is a view of the display of the first preferred embodiment of the interface of the invention, showing several points on the 3-D display pane, a current direction vector and a desired direction vector;

FIG. 4C is a view of the display of the first preferred embodiment of the interface of the invention, showing the anatomical model in the 3-D display pane, with the picture-in-picture feature turned off;

FIG. 4D is a view of the display of the first preferred embodiment of the interface of the invention, showing the bull's eye display in the 3-D display pane;

FIG. 4E is a view of the display of the first preferred embodiment of the interface of the invention, showing the bull's eye display in the picture-in-picture portion of the 3-D display pane;

FIG. 4F is a view of the display of the first preferred embodiment of the interface of the invention, showing the bull's eye display in the picture-in-picture portion of the 3-D display pane, and anatomical model in the main 3-D display with the viewpoint changed fromFIG. 4E;

FIG. 4G is a view of the display of the first preferred embodiment of the interface of the invention;

FIG. 4H is a view of the display of the first preferred embodiment of the interface of the invention;

FIG. 4I is a view of the display of the first preferred embodiment of the interface of the invention;

FIG. 4J is a view of the display of the first preferred embodiment of the interface of the invention;

FIG. 5 is an enlarged view of the 3-D display pane of the first preferred embodiment of the interface of this invention;

FIG. 6A andFIG. 6B are left anterior oblique (LAO) and right anterior oblique (RAO) images of the procedure site with desired orientation arrow and visualization surface superposed thereon;

FIG. 6C is an alternate implementation of the visualization surface superposed thereon;

FIG. 7 is an enlarged view of the status pane of the first preferred embodiment of the interface of this invention;

FIG. 8A is an enlarged view of the 2-D navigation pane of the first preferred embodiment of the interface of this invention;

FIG. 8B is an enlarged view of an alternate embodiment of the 2-D navigation pane ofFIG. 8A;

FIG. 9 is an enlarged view of the point navigation pane of the first preferred embodiment of the interface of this invention;

FIG. 10 is an enlarged view of the vector navigation pane of the first preferred embodiment of the interface of this invention;

FIG. 11 is an enlarged view of the bull's eye navigation pane of the first preferred embodiment of the interface of this invention;

FIG. 12 is a view of an x-ray image showing the projection of the bull's eye screen thereon;

FIG. 13 is an enlarged view of the menu bar of the first preferred embodiment of the interface of this invention;

FIG. 14 is a schematic diagram of the display of a second preferred embodiment of the interface of this invention;

FIG. 15 is a view of the display of the second preferred embodiment of the interface of this invention;

FIG. 16 is a view of the display of the second preferred embodiment of the interface of this invention, showing an alternate image inpane308;

FIG. 17 is a view of the display of the second preferred embodiment of the interface of this invention, showing the use oftarget navigation pane314;

FIG. 18 is a view of the display of the second preferred embodiment of the interface of this invention, showing a possible path of a medical device;

FIG. 19 is a view of the display of the second preferred embodiment of the interface of this invention, showing an elliptical constellation of points and a possible path of a medical device to the constellation;

FIG. 20 is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, with two main panes;

FIG. 21 is a view of a display of a third preferred embodiment of an interface of the third embodiment, with four main panes;

FIG. 22A is a view of a display of the third preferred embodiment, with biplanar images in the main panes, showing the selection of a point in creating a predetermined branched path;

FIG. 22B is an enlarged view of the biplanar images in the main panes;

FIG. 23A is a view of a display of the third preferred embodiment, with biplanar images in the main panes, showing the completion of a predetermined branched path;

FIG. 23B is an enlarged view of the biplanar images in the main pane ofFIG. 23A;

FIG. 24A is a view of a display of the third preferred embodiment, with biplanar images in the main panes, showing the specification of a navigation field at an application point;

FIG. 24B is an enlarged view of the biplanar images in the main pane ofFIG. 24A;

FIG. 25A is a view of a display of the third preferred embodiment, with biplanar images in the main panes, showing the specification of a navigation field at an application point;

FIG. 25B is an enlarged view of the biplanar images in the main pane ofFIG. 25A;

FIG. 26A is a view of a display of the third preferred embodiment, with biplanar images in the main panes, showing the exemplary branched path;

FIG. 26B is an enlarged view of the biplanar images in the main pane ofFIG. 26A;

FIG. 27A is an enlarged view of a pattern navigation control pane of the third preferred embodiment of this invention;

FIG. 27B is an enlarged view of the pattern navigation control pane after navigation of the medical device to the first new position in the pattern;

FIG. 27C is an enlarged view of the pattern navigation control pane as the medical device is moved from the first new position in the pattern to the second new position;

FIG. 27D is an enlarged view of the pattern navigation control pane after navigation of the medical device to the second new position in the pattern;

FIG. 28 is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, showing another control for specifying the direction of the magnetic field to be applied;

FIG. 29 is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, showing another control for specifying the direction of the magnetic field to be applied;

FIG. 30A is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, showing an orientation element;

FIG. 30B is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, showing an orientation element;

FIG. 30C is a view of a display of a third preferred embodiment of an interface in accordance with the principles of this invention, showing an orientation element; and

FIG. 31 is a schematic view of the hardware for operating the user interface used in a fourth preferred embodiment of this invention;

FIG. 32 is view of the main menu control screen of the fourth preferred embodiment of a user interface in accordance with the principles of the present invention;

FIG. 33 is a view of a display from the basic mode of the fourth preferred embodiment of a user interface;

FIG. 34A is a view of a display from the EP mode of the fourth preferred embodiment of a user interface, in the right atrium mode;

FIG. 34B is a view of an alternative to the display ofFIG. 34A;

FIG. 35 is a view of a closed spline indicator used in the spherical object navigation mode of the preferred embodiment of the present invention;

FIG. 36 is a view of an ostium indicator used in the spherical object navigation mode of the preferred embodiment of the present invention;

FIG. 37 is a view of a surface constellation indicator used in the spherical navigation mode of the preferred embodiment of the present invention

FIG. 38 is a view of a control pane for a catheter adjustment mode of the user interface of the preferred embodiment;

FIG. 39 is a view of a pane for a catheter adjustment mode of the user interface of the preferred embodiment,

FIG. 40 is a view of the spherical navigation mode of the preferred embodiment of the user interface;

FIG. 41 is a view of the spherical navigation mode of the preferred embodiment;

FIG. 42 is an enlarged partial view of the spherical object used in the spherical object navigation mode of the preferred embodiment of the present invention;

FIG. 43A is a view of a display from the EP mode of the fourth preferred embodiment of a user interface, in the right atrium mode;

FIG. 43B is a view of an alternative to the display ofFIG. 43A;

FIG. 44 is a view of a display from the EP mode of the fourth preferred embodiment of a user interface, in the full heart mode;

FIG. 45A a view of a display from the EP mode of the fourth preferred embodiment of a user interface, in the left atrium mode;

FIG. 45B is a view of an alternative to the display ofFIG. 45A;

FIG. 46 is a view of a display from the CRT mode of the preferred embodiment of the user interface;

FIG. 47 is an alternate view of a display from the CRT mode of the preferred embodiment of the user interface

FIG. 48A is a view of the display of an anatomical object navigation mode;

FIG. 48B is an alternate view of the selections made;

FIG. 49A is an enlarged view of Alignment window, shown in the auto mode; and

FIG. 49B is an enlarged view of the Alignment window, shown in the manual mode.

Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

This invention relates to an interface for a navigation system for orienting the distal end of a medical device inside a patient's body. As shown inFIG. 1 the interface, indicated generally as20, comprises aprocessor22, adisplay24, and aninput device26. Thedisplay24 preferably includes at least onemonitor28, which may be a flat panel LCD display which is small, compact, and less prone to interference. Theinput device26 may include akeyboard32, amouse34, atrack ball36,microphone38, or other device for controlling a cursor on thedisplay24.

A possible implementation of an interface system is indicated inFIG. 2, in which components of the interface are distributed in theprocedure room50 where the patient is located, and acontrol room52. Thecontrol room52 is preferably adjacent theprocedure room50, and there may be awindow54 between the control room and the procedure room to permit direct observation of the patient, however the control room could be remote from the patient, and with the aid of the present interface, a physician could conduct a procedure on a patient in the procedure from a control room on a different floor, in a different building, or even in a different city.

As shown inFIG. 2, a magnetic surgery suite comprising apatient bed56, and amagnetic navigation system58 comprising opposed

magnet units

60 and62 on opposite sides of the patient bed operated by aprocessor64 and controlled bycontrols66 adjacent thepatient56. Animaging system68, such as a x-ray imaging on a C-arm, displays images of the operating region on amonitors70 in theprocedure room50. The interface system of the present invention provides a convenient way for a physician to operate themagnetic navigation system58 to control the distal end of a medical device in the operating region inside the patient's body.

The interface includes a display on, for example, anLCD monitor72, and amouse74 in theprocedure room50, aprocessor76, a display on, for example, monitor78, akey board80, and amouse82 in thecontrol room54. Additional displays on

monitors

86 and88 can be provided in theprocedure room50 which integrate images from theimaging system68 with the interface. One or moreadditional monitors90 can be provided in the control room so that the images are available in the control room as well. The

monitors

72 and78 preferably display a multi-pane display.

In a first preferred embodiment, as shown in FIGS.3 thedisplay100 on the

monitors

72 and78, includes amenu bar102, atool bar104, a 3-D display pane106, astatus area108, a 2-Danatomical control pane110, a pointnavigation control pane112, and a vectornavigation control pane114, and a bull's eyenavigation control pane116. Of course thedisplay100 could include additional panes or fewer panes or different panes. An example of a display in accordance with this invention is shown inFIG. 4.

A 3-D display pane106 in accordance with this invention is shown inFIG. 5. The display preferably includes a three-dimensional representation120 of the patient orientation. As shown inFIG. 5 thisrepresentation120 may be a representation of a horizontal grid corresponding to the surface of thepatient support56. Alternatively, the may be a three dimensional representation of an idealized patient, or of thepatient support56. A coordinate system122 is optionally included in the representation to facilitate the physician's understanding of the orientation. In the first preferred embodiment, the coordinate system122 comprises a longitudinal axis122x, which might for example be colored blue, a horizontal axis122y, which might for example be colored red, and a anterior-posterior axis122z, which might, for example be colored green. Thepane106 preferably also includes asubpane124 that displays three dimensional representation of the operating region. In this first preferred embodiment this representation is an transparent, three dimensional idealized representation of the portion of the patient's body in which the procedure is taking place, e.g. a human heart as shown inFIG. 5. To facilitate the user's interpretation of the image, the image may be displayed over a horizontal backing grid. Instead of an idealized representation of the procedure site, the image could be an actual preoperative image, or an actual current image. A coordinatesystem126 is optionally included in the representation to facilitate the user's understanding of the orientation. In the first preferred embodiment, the coordinatesystem126 comprises alongitudinal axis126x, parallel to the direction as axis122x, and which may similarly be colored blue, ahorizontal axis126y, parallel to the direction of axis122y, and which may similarly be colored red, and a anterior-posterior axis126z, parallel to the direction of axis122z, and which may similarly be colored green.

Thetool bar104 includes a 3D tool bar128 with controls for controlling the 3-D display pane106. In this first preferred embodiment, these controls include atranslation button130, amagnification button132, arotation button134, apoint selection button136, apoint centering button138, animage autorotate button140, aswap button142, and animage capture button144. These buttons are preferably “virtual buttons”, i.e., they are elements on the display which the user can operate by pointing a cursor and clicking.

A viewselection menu bar146 is also provided on the 3D tool bar128. Theview selection menu146 has an arrow that can be operated to drop down a menu of views to display in thepane106. These preferably include cranial, caudal, anterior, posterior, left and right, as well as one or more user defined views. Of course other standard views could be provided depending upon the procedures for which the interface is used.

Thetranslation button130 can be actuated to enter the viewpoint translation mode by pointing the cursor to the button and clicking. In the viewpoint translation mode, the cursor might change in appearance, for example to a shape corresponding to the icon on thebutton130. In this mode the view point can be changed by grabbing the image by clicking when the cursor is on the image, and dragging the cursor to move the image and thus the viewpoint in any direction. The cursor can be moved using

mouse

74 or82. This preferably also causes a corresponding translation of the view point of the image in thesubpane124.

Themagnification button132 can be operated to enter the magnification or zoom mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the zoom mode the cursor might change in appearance, for example to a shape corresponding to the magnifying glass icon on thebutton132. In this mode the magnification of thepatient reference image120 can be accomplished by grabbing the image by pointing the cursor and clicking, and dragging the cursor downwardly and/or to the right to increase the magnification, or upwardly or to the left to decrease the magnification. Changing the size of the patient reference image preferably also does not change the size of the procedure site reference image.

Therotation button134 can be operated to enter the image rotation mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the image rotation mode the cursor might change in appearance, for example to a shape corresponding to the shape on thebutton134. In this mode the image can be rotated by grabbing the image by pointing the cursor and clicking, and dragging the cursor horizontally to rotate the view point of the image about a generally vertical axis, and vertically to rotate the view point about a generally horizontal axis. Of course the image can be dragged both horizontally and vertically to rotate the axis about a diagonal axis. Rotating the patient reference image preferably also rotates the procedure site reference image, so that these two images always have the same viewpoint.

The pointselect button136 can be operated to enter the point selection mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the point selection mode the cursor might change in appearance, for example to a shape corresponding to the shape on thebutton136. In this mode a point in theimage120 can be selected by moving the cursor over a point on image and clicking, for example with

mouse

74 or82. The selection of the point causes the point to be identified on thepoint navigation pane112, as described in more detail below.

Thepoint center button138 can be operated to enter the point selection mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the point center mode the cursor might change in appearance, for example to a shape corresponding to the shape on thebutton138. In this mode the view point for theimage120 can be centered upon a selected point by moving the cursor over a point on image and clicking, for example with

mouse

74 or82.

Theautorotation button140 can be operated to enter the autorotation mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the autorotation mode the cursor might change in appearance, for example to the shape corresponding to shape on the rotation button. In this mode the viewpoint for the image rotates automatically horizontally to the left. The direction of the rotation can be changed by pointing the cursor on the image and clicking and dragging in the desired new direction of rotation.

Theimage swap button142 can be operated to swap the images displayed in themain pane106 and in thesubpane124 by pointing the cursor to the button and clicking, for example with

mouse

74 or82.

Theimage capture button144 can be operated to enter the image capture mode by pointing the cursor to the button, and clicking, for example with

mouse

74 or82. This opens a box that allows the user to save the image on thepane106 for future reference.

The interface preferably displays a visual indicator of the desired orientation for the distal end of the medical device. In this first preferred embodiment, this indicator is anarrow150, whose shaft is aligned with the desired orientation, with a large conical head pointing in the desired direction. Thearrow150 is preferably a distinctive color such as green. The interface preferably also displays a visual indicator of the current orientation of the distal end of the medical device. In this first preferred embodiment, this indicator is anarrow152, whose shaft is aligned with the current orientation of the distal end of the medical device, with a larger conical head pointing in the desired direction.

A localization system could be provided for determining the current position and orientation of the distal end of the medical device. An image representative of the distal end of the medical device can then be generated and displayed in thepane106. There are numerous method for localizing the distal end of the medical device, for example transmitting magnetic signals between one or more reference locations and the medical device, x-ray image processing, ultrasound localization, or electric potential localization.

In the first preferred embodiment, the interface is adapted for use with a magnetic navigation system that operates by generating a magnetic field of selected direction in the operating region, which causes a magnetically responsive element associated with the distal end of the medical device to generally align with the applied field. Because of the physical properties of the catheter, limitations in the strength of the applied field, and the conditions in the procedure site, the distal end of the medical device may not align precisely with the applied magnetic field. While the difference between the applied magnetic field and the actual direction of the distal end of the medical device can be accounted for through modeling or a look-up table, in the first preferred embodiment thearrow150 representing the desired orientation may represent the desired direction of the applied magnetic field, rather than the desired direction of the medical device itself. Similarly, thearrow152 representing the current orientation may represent the direction of the magnetic field to currently being applied, rather than the actual direction of the device itself. However, the differences between the actual direction of the medical device and the applied magnetic field can be characterized by equation or an empirically determined look-up table, or localization of the device can be provided so that even when used with a magnetic navigation system, thearrow150 represents the actual desired orientation of the medical device, andarrow152 represents the actual current direction.

To help visualize the three-dimensional direction of the indicator, thearrow150 can be surrounded with an “umbrella”154—a shape or surface surrounding the arrow so that its direction and orientation can be more easily visualized. One implementation of theumbrella154 is as a wire frame hemisphere. In addition to improving the visualization of the direction of thearrow150, theumbrella154 can be used to selection the orientation of thearrow150. When the cursor hovers over the surface of the umbrella, the cursor can change appearance, for example to resemble the rotation icon onbutton134. The direction of thearrow150 can be changed by rotating the hemisphere by pointing the cursor to the hemisphere, clicking, and dragging the cursor in the desired direction of rotation. In addition thearrow150 andhemisphere154 can be configured so that when the cursor hovers over the root of thearrow150, the cursor can change in appearance, for example to resemble the translation icon onbutton130. The position of the root of thearrow150 can be changed by clicking the cursor and dragging the cursor in the desired direction of movement.

In the first preferred embodiment, the interface includes displays of the fluoroscopic images of the operating region, with thearrow150 superposed thereon. For example, as shown inFIGS. 6A and 6B, theimaging system68 can provide biplanar images of the operating region, and thearrow150 andumbrella154 provided on each image. These images could be displayed on

monitors

86 and88 in theprocedure room50, and onmonitor90 in thecontrol room52. Preferably, the user can change the direction of thearrow150 on these images as well by rotating and translating the arrow and umbrella as described above.

Thedisplay100 of the interface preferably also includes astatus area108, where, as shown inFIG. 7, a text, graphic, or combination text and graphic message of the status of the interface can be displayed to the user. These messages can be colored coded for example to convey an immediate impression of the importance or significance of the message displayed.

While the orientation of the distal end of the medical device can be manipulated directly on thepane106, for example by manipulating theumbrella154, thedisplay100 of the interface preferably includes at least one pane to aid the user in selecting the desired orientation for the medical device. In this first preferred embodiment there are several panes that provide alternative methods for the user to select the desired orientation for the distal end of the medical device. These panes include representations of the orientation of thearrow150 which are constantly updated, so that use of one pane to change the desired direction of the medical device, causes all of the other panes to update, to facilitate the use of any of the panes to adjust the orientation of thearrow150 representing the desired new orientation of the medical device.

One such pane to aid the user in selecting the desired orientation for the medical device is the 2-Danatomical pane110, which allows the user to select the desired orientation of distal end of the medical device as indicated by thearrow150 by adjusting the direction in one or more planes through the patient. As shown inFIG. 8A, thepane110 allows the user to change the direction of thearrow150 in at least one plane, and preferably at least two planes and more preferably at least the planes. These planes are preferably, but not necessarily, mutually perpendicular. While adjustment in two planes is sufficient to specify any direction, providing adjustment in three planes makes it easier for a user to select the desired direction for thearrow150. In this first preferred embodiment, the arrow can be rotated in the coronal or frontal plane (i.e., about an anterior-posterior axis), the median or saggital plane (i.e., about a horizontal axis), and the horizontal or transverse plane (i.e., about a longitudinal axis).

As shown inFIG. 8A thepane110 can have three

graphic displays

160,162 and164, corresponding to the three planes of rotation.Graphic display160 contains a graphic depiction of the coronal or frontal plane (i.e., an caricature image of a patient's body in the coronal or frontal plane), with anindicator166 that indicates the orientation of the arrow in the coronal or frontal plane, and

virtual buttons

168 and170 for moving the indicator166 (and thus the arrow150) clockwise or counterclockwise in the coronal or frontal plane abut the anterior-posterior axis. In this first preferred embodiment,indicator166 is actually a projection of thearrow150 in the plane, and thus the length of theindicator166 is indicative of the orientation. The

virtual buttons

168 and170 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click the button and move theindicator166 and thus thearrow150, in the desired direction.Display162 contains a graphic depiction of the median or saggital plane (i.e., a caricature image of a patient's body in the median or saggital plane), with anindicator172 indicating the direction of thearrow150 in the median or saggital plane, and

virtual buttons

174 and176 for moving the indicator172 (and thus the arrow150) clockwise or counterclockwise in the coronal or frontal plane. In this first preferred embodiment,indicator172 is actually a projection of thearrow150 in the plane, and thus the length of theindicator172 is indicative of the orientation. The

virtual buttons

174 and176 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click and move theindicator172 and thus thearrow150, in the desired direction.Display164 contains a graphic depiction of the horizontal or transverse plane (i.e., a caricature image of a patient's body in the horizontal or transverse plane), with anindicator178 indicating the direction of the arrow in the horizontal or transverse plane, and

virtual buttons

180 and182 for moving the indicator178 (and thus the arrow150) clockwise or counterclockwise in the horizontal or transverse plane. The

virtual buttons

180 and182 can be operated with a cursor for example with the

mouse

58 or66 or thekeyboard64, to point and click to move theindicator178, and thus thearrow150 in the desired direction.

Thepane110 also includes amenu184 to select the increment of change in direction upon operating the

buttons

168 and170,174 and176, and180 and182. The user can select the incremental change from 1 degree, 2 degrees, 3 degrees, 5 degrees, 10 degrees with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click to select the desired increment.

An alternate implementation of thepane110′ is shownFIG. 8B. In contrast toFIG. 8A wherepane110 allows movement of thearrow150 relative to the coronal or frontal plane, the median or saggital plane, and the horizontal or transverse plane, inFIG. 8B thepane110′ allows movement of thearrow150 relative to the right anterior oblique plane, the left anterior oblique plane, and the transverse plane. As shown inFIG. 8B thepane110 can have threegraphic displays160′,162′ and164′, corresponding to the three planes of rotation.Graphic display160′ contains a graphic depiction of the right anterior oblique plane (i.e., an caricature image of patient's body or part of the patient's body in the RAO plane), with anindicator166′ that indicates the orientation of the arrow in the coronal or frontal plane, andvirtual buttons168′ and170′ for moving theindicator166′ (and thus the arrow150) clockwise or counterclockwise in the left anterior oblique plane. In this first preferred embodiment,indicator166′ is actually a projection of thearrow150 in the plane, and thus the length of theindicator166′ is indicative of the orientation. Thevirtual buttons168′ and170′ can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click the button and move theindicator166′ and thus thearrow150, in the desired direction. Display172′ contains a graphic depiction of the left anterior oblique plane (i.e., a caricature image of a patient's body or portion of the patient's body in the LAO plane), with anindicator172′ indicating the direction of thearrow150 in the median or saggital plane, andvirtual buttons174′ and176′ for moving theindicator172′ (and thus the arrow150) clockwise or counterclockwise in the coronal or frontal plane. In this first preferred embodiment,indicator172′ is actually a projection of thearrow150 in the plane, and thus the length of theindicator172′ is indicative of the orientation. Thevirtual buttons174′ and176′ can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click and move theindicator172′ and thus thearrow150, in the desired direction. Display164′ contains a graphic depiction of the horizontal or transverse plane (i.e., a caricature image of a patient's body or a portion of the patient's body in the horizontal or transverse plane), with anindicator178′ indicating the direction of the arrow in the horizontal or transverse plane, andvirtual buttons180′ and182′ for moving theindicator178′ (and thus the arrow150) clockwise or counterclockwise in the horizontal or transverse plane. Thevirtual buttons180′ and182′ can be operated with a cursor for example with the

mouse

58 or66 or thekeyboard64, to point and click to move theindicator178′, and thus thearrow150 in the desired direction.

Thepane110′ also includes amenu184′ to select the increment of change in direction upon operating thebuttons168′ and170′,174′ and176′, and180′ and182′. The user can select the incremental change from 1 degree, 2 degrees, 3 degrees, 5 degrees, 10 degrees with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click to select the desired increment.

Another pane to aid the user in selecting the desired orientation for thearrow150 and thus for the medical device is apoint navigation pane112. As shown inFIG. 9, thepoint navigation pane112 includes a group menu table200 containing information about one or more groups of points the user identifies. The group menu table200 includes acolumn200awith a color indicator for indicating the color corresponding to the points in the group. All points in the group will be indicated with a mark in the indicated color. The menu table200 further includes acolumn200bentitled “Group Name” with the name of a stored group of points. The menu table200 further includes acolumn200centitled “3D” which indicates whether the group of points is visible on the 3D display in pane106 (“show”) or not visible on the 3D display in the pane (“hide”). Finally, the table comprises acolumn200 entitled “Fluro” which indicates whether the group of points is visible on the 3D display in pane106 (“show”) or not visible on the 3D display in the pane (“hide”).

A “new”button202, a “delete”button204, and an “edit”button206 are associated with the menu table200. The

buttons

202,204, and206 are preferably “virtual” buttons, i.e. portions of the display on which the user points the cursor and clicks, for example with

mouse

74 or82, orkeyboard82. Thenew button202 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to create a new group in the menu table200. Operating thenew button202 opens a box that allows the user to select the color indicator incolumn200a, select the name of the group incolumn200b, select the display properties incolumn200cbetween “show” and “hide” to determine whether the points will appear on the3D panel110, and select the display properties incolumn200d, between “show” and “hide” to determine whether the points will appear on the fluoroscope displays (monitors86,88, and90). Thedelete button204 can be operated by pointing and clicking with the cursor using the74 or82, orkeyboard82, and allows the user to delete the group or groups that the user highlighted in the menu table114, using the

mouse

74 or82, orkeyboard82. Theedit button206 can be operated by pointing and clicking with the cursor using the

mouse

74 or82, orkeyboard82, and allows the user to edit the group that the user highlighted in the menu table200 using the74 or82, orkeyboard82. Operating theedit button206 opens a box that allows the user to change the color indicator incolumn200a, change the name of the group incolumn200b, change the display properties incolumn200cbetween “show” and “hide” to determine whether the points will appear on the3D panel110, and change the display properties incolumn200d, between “show” and “hide” to determine whether the points will appear on the fluoroscope displays (monitors86,88, and90).

Thepane112 also includes a point menu table208. The menu table208 includes acolumn208a, entitled “id” for an identification code assigned by the system to a particular point (in the first preferred embodiment the system assigns an id from A to ZZ). The menu table208 further includes acolumn208b, entitled “point name” for the name of the point. Finally, the menu table208 includes athird column208centitled “group” for the name of the group to which the point is assigned. A display control is provided adjacent the point menu table208 for selection the points to display in the point menu table208. As shown inFIG. 9, the display control can comprise radio buttons210 and212, which allow the user to specify “all groups” or “selected group”, respectively, so that the user can identify whether to display the points in “all groups” or just the points a selected group “selected group” in the menu table208.

An “edit”button214, a “delete”button216, a “group”button218, and a “vector”button220 are associated with the menu table208. The

buttons

214,216,218, and220 are preferably “virtual” buttons on the display that can be operated by pointing the cursor and clicking, for example with

mouse

74 or82, orkeyboard80. The user can select a point on the menu table200 by pointing with the cursor and clicking, using the

muse

74 or82, or thekeyboard80. Theedit button214 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to edit the selected point. Operating the edit box opens a box that allows the user to change the name of the selected point incolumn208b, and the group to which the point iscolumn208c. Thedelete button216 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to delete the selected point. Thegroup button218 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to change the group to which the selected point is associated. Thevector button220 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to set the orientation of thearrow150 to the orientation associated with a point selected on the menu table208 using the

mouse

74 or82 orkeyboard80. This automatically updates the display ofarrow150 in the other panes. Thus a user who wants to navigate back to a stored point can recall the direction associated with that point, facilitating the return to the point. However that direction may also be useful in navigating to another point.

Another such pane to aid the user in selecting the desired orientation for the medical device is avector navigation pane114. Thevector navigation pane114 allows the user to use predetermined directions, to store and use new directions, and to recall and use previously used directions. Thevector navigation pane114 includes asection222 for recalling and using predetermined directions; a direction vector storage andrecall section224; and a direction history andrecall section226. Thesection222 for recalling and using predetermined directions includes a “preset list”pick menu228 for selecting a particular set of predetermined directions, and a “direction”pick menu230 for selecting a particular direction from the selected set. A set of possible “preset list” and “direction” entries for the

pick menus

228 and230 is shown in Table 1. The user can select from the “preset list” and “direction” pick menus using the

mouse

74 or82 orkeyboard80.

TABLE 1


Possible Preset Lists and Directions

	Cardinal	Superior
	Cardinal	Inferior
	Cardinal	Anterior
	Cardinal	Posterior
	Cardinal	Left
	Cardinal	Right
	Cardinal	RAO
	Cardinal	LAO
	Deflection	From 0 to 175° in 15°
		increments

The direction vector storage andrecall section224 includes a vector menu table232, and associated “store”button234, “edit”button236, “delete”button238. The

buttons

234,236, and238 are preferably virtual buttons, or portions of the display to which the cursor can be pointed and clicked, for example with the

mouse

74 or82, or thekeyboard80. The “store”button234 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to store the current direction under a user selected name on the vector menu table232. Operating thestore button234 opens a box that allows the user to input a name. The user can selected a stored direction from the menu table232 by pointing to the name with the cursor, and clicking, using the

mouse

74 or82, orkeyboard80. The “edit”button236 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to edit the name of a selected direction. The “delete”button238 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to delete a selected direction. Thehistory section226 includes virtual forward and

back buttons

240 and242. The forward and

back buttons

240 and242 can be operated by pointing the cursor and clicking using

mouse

74 or82 orkeyboard80. The

buttons

240 and242 allow the user to set the orientation of thearrow150 to one of the previously selected directions, which are automatically stored. In the first preferred embodiment, the system automatically stores the last ten directions, and the user can scroll backward and forward through these directions with the

buttons

240 and242. The appearance of the

buttons

240 and242 changes (e.g. grays out) when the there is no further stored directions.

The bull'seye navigation pane116 includes acircular screen250, and an “apply”button252. Thepane116 also includes ascale menu254, which in the first preferred embodiment allows the user to select the scale of thescreen250 from 15, 20, 45, 60, and 90 degrees. The user can select the desired scale for thecircular screen250 by pointing the cursor and clicking, using the

mouse

74 or82 orkeyboard80. Thepane116 may also include adisplay control section256 with “Hide” and “Show”

radio buttons

258 and260. These buttons determine whether thecircular screen250 is projected onto the other displays, specifically the 3D display ofpane106 and the fluoroscopic images from the imaging system displayed on the

monitors

86,88, and90.FIG. 12 shows one of the biplane imaging displays with thescreen250 projected thereon. Thedisplay control section256 also includes RAO (right anterior oblique) and LAO (left anterior oblique)

selection buttons

262 and264, which orient thescreen250 so that the top of the screen is up in whichever of the two views is selected. As shown inFIG. 11,

markers

262 and264 are provided on thecircular screen250, to help the user interpret the orientation of thecircular screen250 on the3D pane106 and the on the RAO and LAO views. Themarker262 might be blue and themarker264 might be red.

The user can set the base direction thenavigation pane116 by operating the “apply”button252 by pointing at the button with a cursor and clicking, using

mouse

74 or82 orkeyboard80. The sets the current direction as the direction though the center of thescreen250. The user can then specify a direction for thearrow150 by selecting a point on thescreen250, by pointing with the cursor and clicking, using

mouse

74 or82, orkeyboard80. As shown inFIG. 11, thescreen250 has vertical andhorizontal cross hairs266 and268, and a plurality of radially extending markers270, at 30 degree intervals. There are a plurality of concentriccircular markers272 representing regular angular intervals (10 degree intervals in the first preferred embodiment), with specified intervals (30 degree intervals in the first preferred embodiment) indicated bybold markers272a. Thecircular screen272 actually represents a hemisphere of space. The screen allows the user to orient thearrow150 at a number of points to draw radial and circular lines.

Thetoolbar104 preferably also includes anindicator280, an applybutton282, areduce button284, and anangle indicator286. Theindicator280 indicates when the interface is connected to the magnetic navigation system. Of course if some other system for orienting the distal end of the medical device is used, a suitable indicator can be provided. The applybutton282 and thereduce button284 are preferably virtual buttons which are operated by pointing the cursor and clicking, for example with

mouse

74 or82, orkeyboard80. Operating the applybutton282 causes the magnetic navigation system to apply a magnetic field to orient the distal end of the medical device in the orientation of thearrow150. Operating thereduce button284 causes the magnetic navigation system to “turn off” the magnetic field. Theindicator286 indicates the angular difference between the previously applied magnetic field and the orientation ofarrow150. Of course rather than discrete navigation, in which thearrow150 is successively oriented and the magnetic field applied, the interface could be adapted to operate in a continuous navigation mode in which the field is automatically applied in the direction ofarrow150 Operation

In operation the user can visualize the current direction of the device represented byarrow154 and the desired new direction for the device represented byarrow150, on the 3-D pane106 or on the x-ray images on

monitors

86,88, and90. The user can selected the orientation of thearrow150 in a number of

ways using panes

110, or112, or114, or116.

The user can select the orientation ofarrow150 onpane110 by clicking on

buttons

168 and170,174 and176, and180 and182, to move thearrow150 in each of the coronal or frontal plane, the median or saggital plane, and the horizontal or transverse plane to move the arrow. Alternatively, the user can select the orientation ofarrow150 by using thepane112. The user selects a point on the menu table208 by pointing and clicking with the cursor, and then operating thevector button220 by pointing and clicking with the cursor. This sets the orientation ofarrow150 to the orientation associated with point selected. Alternatively, the user can select the orientation ofarrow150 using thepane114. The user can select a stored orientation by selecting a category onmenu228, and a direction onmenu230. The user can select a user-stored direction by selecting a direction vector from the menu table232. The user can select a previously used direction by using the

buttons

240 and242 to recall one of the last previously used direction. Finally, the user can select an orientation by picking a point on ascreen250.

Once the direction of thearrow150 is selected, the navigation system can be operated by operating the applybutton282. This can operate a magnetic navigation system to apply a field in thedirection150, or it can operate a magnetic navigation system to apply a field to cause the medical device to align in thedirection150, either by using feedback of the catheter position or by calculating or using a look-up table to account for the properties of medical device.

In second preferred embodiment, as shown in FIGS.14 thedisplay100′ on the

monitors

72 and78, includes amenu bar302, tool bars304, a 3-D display pane306, a 2-Danatomical control pane308, a pointnavigation control pane310, a vectornavigation control pane312, and a bull's eyenavigation control pane314, anadvancer control pane316, and a title block anddevice selection pane318. Of course thedisplay100′ could include additional panes or fewer panes or different panes. An example of a display in accordance with this invention is shown inFIG. 15.

A 3-D display pane306 in accordance with this invention is shown inFIG. 15. The display preferably includes a three-dimensional representation of the patient orientation. As shown inFIG. 15 this representation may be a representation of a horizontal grid corresponding to the surface of thepatient support56. Alternatively, the may be a three dimensional representation of an idealized patient, or of thepatient support56. Thepane306 preferably also includes asubpane324 that displays three dimensional representation of the operating region. In this preferred embodiment this representation is an transparent, three dimensional idealized representation of the portion of the patient's body in which the procedure is taking place, e.g. a human heart as shown inFIG. 15. To facilitate the user's interpretation of the image, the image may be displayed over a horizontal backing grid. Instead of an idealized representation of the procedure site, the image could be an actual preoperative image, or an actual current image. A coordinate system is optionally included in the representation to facilitate the user's understanding of the orientation.

Thetool bar304 includes a3D tool bar328 with controls for controlling the 3-D display pane306. In this second preferred embodiment, these controls include ascreen manipulation button330, agrid button332, adisplay selector button334, aconstellation button336; apoint centering button338, a zoom inbutton340, a zoom outbutton342, and animage capture button344. These buttons are preferably “virtual buttons”, i.e., they are elements on the display which the user can operate by pointing a cursor and clicking.

A viewselection menu bar346 is also provided on the3D tool bar328. Theview selection menu346 has an arrow that can be operated to drop down a menu of views to display in thepane306. These preferably include cranial, caudal, anterior, posterior, left and right, as well as one or more user defined views. Of course other standard views could be provided depending upon the procedures for which the interface is used.

Thescreen manipulation button330 can be actuated (for example by right clicking) to display a plurality of screen manipulation options for the cursor. For example, the user can select among a plurality of cursor modes to translate the image on thedisplay306, to rotate the image on the display, etc., by clicking and dragging the image. The appearance of the cursor on thedisplay306 preferably changes to cue the user as to the particularly screen manipulation mode in effect. In the translation mode, the cursor might change in appearance, for example to a shape corresponding to the icon on thebutton330. In this mode the view point can be changed by grabbing the image by clicking when the cursor is on the image, and dragging the cursor to move the image and thus the viewpoint in any direction. The cursor can be moved using

mouse

74 or82. This preferably also causes a corresponding translation of the view point of the image in thesubpane324.

Thegrid button332 can be clicked to show and hide the grid lines on thedisplay306.

Thedisplay selector button334 allows the user to select the format of thedisplay306. The user can click on the button to cause a menu of icons depicting various formats to drop down. The user then simply selects the desired format, for example including the subpane324 (as shown) or removing thesubpane324.

Thedisplay constellations button336 can be operated to toggle between a display in which points on thedisplay306 are shown as part of a group or constellation (e.g.FIG. 19) by pointing the cursor to the button and clicking, for example with

mouse

74 or82.

Thepoint center button338 can be operated to enter the point selection mode by pointing the cursor to the button and clicking, for example with

mouse

74 or82. In the point center mode the cursor might change in appearance, for example to a shape corresponding to the shape on thebutton338. In this mode the view point for the image can be centered upon a selected point by moving the cursor over a point on image and clicking, for example with

mouse

74 or82.

The zoom inbutton340 allows the user to click to enlarge the image on thedisplay306, and the zoom outbutton342 allows the user to click to reduce the image on thedisplay306 The zoom inbutton340 and the zoom outbutton342 can be operated to enter the magnification or zoom mode by pointing the cursor to the button and clicking for example with

mouse

74 or82. In the zoom mode the cursor might change in appearance, for example to a shape corresponding to the magnifying glass icon with a “+” for zoom in, and a “−” for zoon out. In this mode the magnification of the image can be accomplished by grabbing the image by pointing the cursor and clicking, and dragging the cursor downwardly and/or to the right to increase the magnification, or upwardly or to the left to decrease the magnification. Changing the size of thepatient reference image306 preferably also does not change the size of the procedure site reference image.324

Theimage capture button344 can be operated to enter the image capture mode by pointing the cursor to the button, and clicking, for example with

mouse

74 or82. This opens a box that allows the user to save the image on thepane306 for future reference.

The interface preferably displays a visual indicator of the desired orientation for the distal end of the medical device. In this preferred embodiment, this indicator is anarrow350, whose shaft is aligned with the desired orientation, with a large conical head pointing in the desired direction. Thearrow350 is preferably a distinctive color, e.g. green. The interface preferably also displays a visual indicator of the current orientation of the distal end of the medical device. In this preferred embodiment, this indicator is anarrow352, whose shaft is aligned with the current orientation of the distal end of the medical device, with a larger conical head pointing in the desired direction. Thearrow352 is preferably a distinctive color, different from thearrow350, e.g. yellow.

A localization system could be provided for determining the current position and orientation of the distal end of the medical device. An image representative of the distal end of the medical device can then be generated and displayed in thepane306. There are numerous method for localizing the distal end of the medical device, for example transmitting magnetic signals between one or more reference locations and the medical device, x-ray image processing, ultrasound localization, or electric potential localization.

In the preferred embodiment, the interface is adapted for use with a magnetic navigation system that operates by generating a magnetic field of selected direction in the operating region, which causes a magnetically responsive element associated with the distal end of the medical device to generally align with the applied field. Because of the physical properties of the catheter, limitations in the strength of the applied field, and the conditions in the procedure site, the distal end of the medical device may not align precisely with the applied magnetic field. While the difference between the applied magnetic field and the actual direction of the distal end of the medical device can be accounted for through modeling or a look-up table, in the preferred embodiment thearrow350 representing the desired orientation may represent the desired direction of the applied magnetic field, rather than the desired direction of the medical device itself. Similarly, thearrow352 representing the current orientation may represent the direction of the magnetic field to currently being applied, rather than the actual direction of the device itself. However, the differences between the actual direction of the medical device and the applied magnetic field can be characterized by equation or an empirically determined look-up table, or localization of the device can be provided so that even when used with a magnetic navigation system, thearrow350 represents the actual desired orientation of the medical device, andarrow352 represents the actual current direction.

As in the first preferred embodiment, in the second preferred embodiment, the interface includes displays of the fluoroscopic images of the operating region, with thearrow350 superposed thereon. For example, as shown inFIGS. 6A and 6B, theimaging system68 can provide biplanar images of the operating region, and thearrow350 on each image. These images could be displayed onmonitors86 an88 in theprocedure room50, and onmonitor90 in thecontrol room52. Preferably, the user can change the direction of thearrow150 on these images by rotating and translating the arrow as described above.

While the orientation of the distal end of the medical device can be manipulated directly on thepane306, thedisplay100′ of the interface preferably includes at least one pane to aid the user in selecting the desired orientation for the medical device, and thus of thearrow350. In this preferred embodiment there are several panes that provide alternative methods for the user to select the desired orientation for the distal end of the medical device. These panes include representations of the orientation of thearrow350 which are constantly updated, so that use of one pane to change the desired direction of the medical device, causes all of the other panes to update, to facilitate the use of any of the panes to adjust the orientation of thearrow350 representing the desired new orientation of the medical device.

One such pane to aid the user in selecting the desired orientation for the medical device is the 2-Danatomical pane308, which allows the user to select the desired orientation of distal end of the medical device as indicated by thearrow350 by adjusting the direction in one or more planes through the patient. As shown inFIG. 15, thepane310 allows the user to change the direction of thearrow350 in at least one plane, and preferably at least two planes and more preferably at least the planes. These planes are preferably, but not necessarily, mutually perpendicular. While adjustment in two planes is sufficient to specify any direction, providing adjustment in three planes makes it easier for a user to select the desired direction for thearrow350. In this preferred embodiment, thearrow350 can be rotated in the coronal or frontal plane (i.e., about an anterior-posterior axis), the median or saggital plane (i.e., about a horizontal axis), and the horizontal or transverse plane (i.e., about a longitudinal axis).

As shown inFIGS. 15-19 thepane308 can have three

graphic displays

360,362 and364, corresponding to the three planes of rotation. As shown inFIGS. 15 and 16, the user can preferably select between an anatomy view (FIG. 15) or a whole body view (FIG. 16).Graphic display360 contains a graphic depiction of the coronal or frontal plane (e.g. a caricature image of the organ and/or operation region or a caricature image of a patient's body, in the coronal or frontal plane), with anindicator366 that indicates the orientation of the arrow in the coronal or frontal plane, and

virtual buttons

368 and370 for moving the indicator366 (and thus the arrow350) clockwise or counterclockwise in the coronal or frontal plane abut the anterior-posterior axis. In this preferred embodiment,indicator366 is actually a projection of thearrow350 in the plane, and thus the length of theindicator366 is indicative of the orientation. The

virtual buttons

368 and370 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click the button and move theindicator366 and thus thearrow350, in the desired direction.Display362 contains a graphic depiction of the median or saggital plane (i.e., a caricature image of a patient's body in the median or saggital plane), with anindicator372 indicating the direction of thearrow350 in the median or saggital plane, and

virtual buttons

374 and376 for moving the indicator372 (and thus the arrow350) clockwise or counterclockwise in the coronal or frontal plane. In this preferred embodiment,indicator372 is actually a projection of thearrow350 in the plane, and thus the length of theindicator372 is indicative of the orientation. The

virtual buttons

374 and376 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click and move theindicator372 and thus thearrow350, in the desired direction.Display364 contains a graphic depiction of the horizontal or transverse plane (i.e., a caricature image of a patient's body in the horizontal or transverse plane), with anindicator378 indicating the direction of the arrow in the horizontal or transverse plane, and

virtual buttons

380 and382 for moving the indicator378 (and thus the arrow350) clockwise or counterclockwise in the horizontal or transverse plane. The

virtual buttons

380 and382 can be operated with a cursor for example with the

mouse

58 or66 or thekeyboard64, to point and click to move the indicator278, and thus thearrow250 in the desired direction.

Thepane308 also includes a menu384 to select the increment of change in direction upon operating the

buttons

368 and370,374 and376, and380 and382. The user can select the incremental change from 1 degree, 2 degrees, 3 degrees, 5 degrees, 10 degrees with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click to select the desired increment.

Instead of using

controls

368 and370,374 and376, and380 and382, to incrementally move the

indicators

366,372. and378, the user can simply point and click on the three

graphic displays

360,362 and364 to move the indicator to the selected point. Moving the indicators either with

controls

368 and370,374 and376, and380 and382, or by selecting points on the

displays

366,372, and378, the user can selected the direction ofarrow350.

Another pane to aid the user in selecting the desired orientation for thearrow350, and thus for the medical device, ispoint navigation pane310. As shown inFIG. 15, thepoint navigation pane310 includes a group menu table400 containing information about one or more groups of points the user identifies. The group menu table400 includes acolumn400afor an icon for identifying the arrangement of the group (a group of points can be thought of as defining a shape, such as a circle, ellipse, or spline much the same way that stars for constellations of shapes). An icon representing unorganized points is shown inFIG. 15, a icon representing an ellipse “constellation” is shown inFIG. 19. Other types of arrangements of points in a group, for example points on fitted curve, and points on a spline, can be identified with different icons in thecolumn400a. Acolumn400b, with the heading “Group Name” includes a color/shape identifier and a name for the group, e.g. “Group 1”. In this second preferred embodiment, a square of a color identifying the group is displayed incolumn400b, but the group could be identified in some other manner. All points in a group will be indicated with a mark in the indicated color, as described in more detail below. The group menu table400 further includes acolumn400cfor a pick box for each group for indicating whether the group should be shown on the bi-plane fluoroscopic imaging screens (on

monitors

86,88, and90), and acolumn400dfor a pick box for each group for indicating whether the group should be shown on the 3D display inpane306.

The identified of points, groups of points, and constellations of points within a group allows the user to simply identify a point or points and have the interface determine the field direction to reach the point or points

Thepane310 also includes a point menu table408. The menu table408 includes acolumn408a, for an identification symbol that indicates (preferably using color) the group to which the point belongs, acolumn408bentitled “ID” that contains a code assigned by the system to a particular point (in this second preferred embodiment the system assigns an ID sequentially from A to ZZ). The menu table208 further includes acolumn208c, entitled “Point Name” for a user specified name of the point. The user can select a group by pointing the cursor on a group in the group menu table400, which causes the point menu table408 to display each of the points in the selected group.

As a further aid to the user in selecting the desired orientation for the medical device, vector

navigation pick menus

428 and430 are provided on thetoolbars304. Thepick menu428 displays a “preset list” pick menu for selecting a particular set of predetermined directions, and thepick menu430 displays a “direction” pick menu for selecting a particular direction from the set selected inwindow428. A set of possible “preset list” and “direction” entries for the

pick menus

428 and430 is shown in Table 2. The user can select from the “preset list” and “direction” pick menus using the

mouse

74 or82 orkeyboard80.

TABLE 2


Possible Preset Lists and Directions

	Cardinal	Superior
	Cardinal	Inferior
	Cardinal	Anterior
	Cardinal	Posterior
	Cardinal	Left
	Cardinal	Right
	Cardinal	RAO
	Cardinal	LAO
	Deflection	Increasing deflection
		from 0 to 175° in 15°
		increments

Vector history buttons

432 and434 are also provided on one of the tool bars304 to aid the user in selecting the desired orientation for the medical device. The

buttons

432 and434 allow the user to move backwardly and forwardly through an automatically stored list of applied magnetic field directions, in order to reapply a previously applied magnetic field. The

buttons

432 and434 allow the user to set the orientation of thearrow350 to one of the previously selected directions, which are automatically stored. In the preferred embodiment, the system automatically stores the last ten directions, and the user can scroll backward and forward through these directions with the

buttons

432 and434. The appearance of the

buttons

432 and434 preferably changes (e.g. grays out) when the there is no further stored directions.

The interface can also include a vector storage andrecall pane312 to store, recall, and use custom directions. The direction vector storage andrecall pane312 includes a vector menu table436, and associated “store”button438, “delete:button440, and “edit”button442. The

buttons

438,440, and442 are preferably virtual buttons, or portions of the display to which the cursor can be pointed and clicked, for example with the

mouse

74 or82, or thekeyboard80. The “store”button438 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to store the current direction under a user selected name on the vector menu table436. Operating thestore button438 allows the user to input a name for the stored direction. The user can selected a previously stored direction from the menu table436 by pointing to the name with the cursor, and clicking, using the

mouse

74 or82, orkeyboard80. The “edit”button442 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to edit the name of a selected direction. The “delete”button440 can be operated by pointing and clicking with the cursor using the

mouse

74 or82 orkeyboard80, and allows the user to delete a selected direction.

The bull'seye navigation pane314 includes acircular screen450, and an “apply”button452. Thepane314 also includes ascale menu454, which in the preferred embodiment allows the user to select the scale of thescreen450 from 15, 20, 45, 60, 90, and 120 degrees. The user can select the desired scale for thecircular screen250 by pointing the cursor at thescale menu454, to display a list of scales, and selecting and clicking on the desired scale, using the

mouse

74 or82 orkeyboard80.FIG. 17 shows thecircular screen450 on thedisplay pane306. As shown inFIG. 17,

markers

462 and464 are provided on thecircular screen450, to help the user interpret the orientation of thecircular screen450 on the3D pane306 and the on the RAO and LAO views. Themarker262 might be blue and themarker264 might be red.

The user can set the base direction thenavigation pane116 by operating the “apply”button452 by pointing at the button with a cursor and clicking, using

mouse

74 or82 orkeyboard80. This sets the current direction as the direction though the center of thescreen450. The user can then specify a direction for thearrow350 by selecting a point on thescreen450, by pointing with the cursor and clicking, using

mouse

74 or82, orkeyboard80. As shown inFIG. 17, thescreen450 has vertical and

horizontal cross hairs

466 and468, and a plurality of radially extendingmarkers470, at 30 degree intervals. There are a plurality of concentriccircular markers472 representing regular angular intervals (10 degree intervals in the preferred embodiment), with specified intervals (30 degree intervals in the preferred embodiment) indicated bybold markers472a. Thecircular screen450 actually represents a hemisphere of space, and is represented as such withhemisphere450′ ondisplay306 inFIG. 17. Thehemisphere450′ includesmarkers462′ and464′ corresponding to the

markers

462 and464 oncircular screen450. Thescreen450 allows the user to orient thearrow350 at a number of points to draw radial and circular lines.

Thetoolbar304 preferably also includes anindicator480, an applybutton482, areduce button484, and anangle indicator486. Theindicator480 allows the user to select among a “manual apply” mode, in which the user must affirmatively apply the selected field, an “automatic” mode in which the selected field direction is automatically applied, and a “locked” mode in which the field cannot be applied without changing the mode to either “manual apply” or “automatic”. The applybutton482 and thereduce button484 are preferably virtual buttons which are operated by pointing the cursor and clicking, for example with

mouse

74 or82, orkeyboard80. Operating the applybutton482 when the interface is not in the automatic or locked modes causes the magnetic navigation system to apply a magnetic field to orient the distal end of the medical device in the orientation of thearrow350. Operating thereduce button484 causes the magnetic navigation system to “turn off” the magnetic field. Theindicator486 indicates the angular difference between the previously applied magnetic field (arrow352) and the desired new orientation (arrow350). Of course rather than discrete navigation, in which thearrow350 is successively oriented and the magnetic field applied, the interface could be adapted to operate in a continuous navigation or automatic mode in which the field is automatically applied in the direction ofarrow350.

The interface also includes anadvancer control pane316. Theadvancer control pane316 displays the length of extension of the medical device being navigated. Thepane316 has three buttons: a reset zero button490, a zoom in button492, and a zoom out button494. Thepane316 also has three user settable flags496,498 and500, and one system settable flag502. The user can use the reset zero button490 to reset the current extension of the medical device as the zero position. The user can advance and retract the medical device using the zoom in and zoom out buttons494 and496. The extension of the medical device from its zero position is displayed as a colored bar on the scale504. The user can set three flags to mark desired locations by operating the virtual buttons496,498, and500. Operating any one of the buttons causes the corresponding flag to appear on the scale504, and allows the user to name the flag for future reference. In modes where the system automatically calculates the applied magnetic field and extension to reach a particular target, the system displays the path of the device a dashed line, the required field as a green arrow, and the required extension by positioning the system flag502 on the scale504. This aids the user in extending or retracting the medical device to the proper position to reach the target.

The interface also includes aninformation block318, displaying the version of the software, and including a pick window506 to allow the user to select the particular type of device being navigated. The properties of the device are then used in calculating and displaying the configuration of the device to reach a selected point, and determining the required magnetic field and device extension to reach the desired point.

Operation

In operation the user can visualize the current direction of the device represented byarrow352 and the desired new direction for the device represented byarrow350, on the 3-D pane306 or on the x-ray images on

monitors

86,88, and90. The user can selected the orientation of thearrow350 in a number of

ways using panes

308, or310, or314, using the

menus

328 and330 on the tool bars304, or simply selecting a point in the three dimensional display, and allowing the system to calculate the field and direction to reach a selectedpoint16. SeeFIG. 18.

The user can select the orientation of arrow350 (representing the magnetic field to apply) in a variety of ways. Onpane308 the user clicks on

buttons

368 and370,374 and376, and380 and382, to move thearrow350 in each of the coronal or frontal plane, the median or saggital plane, and the horizontal or transverse plane to move the arrow. Alternatively, the user can select the orientation ofarrow350 by using thepane312. The user selects a point on the menu table408 by pointing and clicking with the cursor to set the orientation ofarrow350 to the orientation associated with point selected. Alternatively, the user can select the orientation ofarrow350 using thepane312. The user can select a stored orientation by selecting a category onmenu428, and a direction onmenu430. The user can select a user-stored direction by selecting a direction vector from the menu table436. The user can select a previously used direction by using the

buttons

432 and434 to recall one of the last previously used direction. Finally, the user can select an orientation by picking a point on ascreen450 inpane314.

Once the direction of thearrow350 is selected, the navigation system can be operated by operating the applybutton482. This can operate a magnetic navigation system to apply a field in thedirection350, or it can operate a magnetic navigation system to apply a field to cause the medical device to align in thedirection350, either by using feedback of the catheter position or by calculating or using a look-up table to account for the properties of medical device.

A third embodiment of an interface is illustrated inFIGS. 20-26. The interface is adapted for controlling a magnetic navigation system that applies a magnetic field in a selected direction to an operating region in a subject to magnetically orient a medical device in the operating region. The interface comprises adisplay602 on which at least one image of the operating region is displayed, and in this preferred embodiment the display has

panes

604 and606 for displaying images of the operating region from two different planes, to facilitate identifying points in three dimensional space in the operating region. The interface further comprises an input device, such as a mouse (not shown) for identifying points in the operating region on the at least one image on the display, for example by moving a cursor or other indicator over the display, and “clicking” on the selected point. Of course the interface could be any other device for identifying points on the display, including joysticks, touch screen displays, light pens, etc. By identifying a point on the image on each of the

panes

604 and606, a user can uniquely identify a point in three-dimensions in the operating region.

The interface includes a processor that, after the user selects a point in the operating region, determining an application point in the operating region which is on a predetermined branched path through the subject's vasculature and which is closest to the identified point. The interface then determines (e.g., by calculation or use of a reference table) the direction that is tangent to the predetermined branched path at the application point. As shown inFIGS. 24 and 25, this direction can be displayed byindicators608, which may be color coded to distinguish them fromindicators609 of the previously applied direction. The interface, preferably through the processor, then causes the magnetic navigation system to apply a magnetic field at the application point, in a direction tangent to the predetermined path at the application point.

As shown inFIGS. 22 and 23, the predetermined branched path can be manually determined prior to beginning the procedure. A user can use the interface to identify a plurality of points on the vasculature in the operating region, uniquely identifying each point in three dimensional space by identifying it on the two

panes

604 and606, using the input device (seeFIG. 22). After points have been identified along the vasculature, the processor can automatically connect the points to form the predetermined branched path by connecting each point with its next nearest neighbors (seeFIG. 23). The processor then can overlay or superimpose the predetermined branched path over the images of the operating region on the

panes

604 and606, so that the user can verify the accuracy of the branched path, and make adjustments if necessary. As shown inFIG. 26, each branch can be displayed in a different color to help the user visualize the operating region. This is particularly helpful when viewing the operating region in two planes on the

panes

604 and606. Where the vasculature curves, or is branched, the points must be identified fairly closely together, while wherein the vasculature in straight and unbranched, the user does not have to identify as many points. Alternatively, the predetermined branched path can be determined through image processing, which can be assisted by the injection of contrast medium, if necessary.

Thus the processor creates the predetermined branched path through the vasculature in an operating region in a subject's vasculature, by accepting the identification of a plurality of points on the subject's vasculature on at least one image of the operating region; and connecting each point with its nearest neighboring point to form the branched path through the vasculature.

The interface thus can be used to operate a magnetic navigation system to apply a magnetic field in a selected direction in an operating region in a subject, to magnetically orient a medical device in the operating region. The user first identifies a plurality of points along the subject's vasculature in an image of the operating region in the subject. The user then connecting each point to the closest adjacent point to create a network of navigable paths through the subject's vasculature. This can be done manually, but is preferably done automatically by a computer processor. The user then identifies a point where on the image of the operating region, where the user wants to navigate. The computer processor can then determine an application point that is on the previously determined network of navigable paths, closest to the selected point. The computer processor also determines the direction tangent to the network of navigable paths at the application point. The interface then causes the magnetic navigation system to apply magnetic field at the application point in a direction tangent to the navigable path at the application point.

The interface accepts the identification of a selected point on an image of the operating region, determines an application point on a predetermined navigable path through the subject's vasculature in the operating region corresponding that is closest to the selected point; and applies a magnetic field at the application point in a direction tangent to the navigable path at the application point. A magnetic navigation system incorporating the interface may have one or more stationary electromagnetic coils, or one or more movable electromagnets and/or permanent magnets. The interface selectively powers the stationary electromagnets, selectively powers and moves the moveable electromagnets, or selectively moves the permanent magnets to apply the appropriate magnetic field at the operating point in the selected direction.

Another control of the interface of the third embodiment is illustrated inFIG. 27. This control operates a magnetic navigation system that applies a magnetic field in a selected direction to an operating region in a subject to magnetically orient a medical device in the operating region. The interface facilitates the specification of the direction of the magnetic field to be applied by the magnetic navigation system, and includes adisplay pane610 on which a representation612 of the current orientation of the medical device (or the currently applied magnetic field) is displayed. In this preferred embodiment the representation612 is a dot614 at the center of a circular grid616 comprising a plurality ofconcentric circles618 representing angular deflections from the axis of the medical device. Thedisplay pane610 also includes aselector620 for selecting one of a plurality of predetermined patterns of new orientations. The interface includes a input device for selecting one of the plurality of patterns of new orientations. This input device may be a mouse and/or a keyboard for operating the selector. Of course, some other input device, such as a joystick, touch screen, etc. could be used for selecting a pattern,

Theselector620 includes a pick box622 for selecting the type of pattern. In this preferred embodiment there are preferably at least two types of patterns, a circular pattern generally concentric about the current position of the medical device, and a spiral pattern originating at the current position of the medical device. The selector preferably also includes a pick box624 for selecting the number of new positions in the pattern. The selector preferably also includes a pick box626 for selecting the angular displacement of the pattern from the current position. The selector may also include a pick box628 for selecting the delay between movement among the positions in the pattern. Lastly, theselector620 can include a previous positionvirtual button630, a next position virtual button632, a play virtual button634, and a stop virtual button636.

The user selects the type of pattern in pick box622, the number of new positions in the pattern in pick box624, the angular displacement of the pattern in pick box626, and if desired a delay time in pick box628. The selected pattern is displayed on the circular grid616 as a plurality of dots638. The user can then operate the magnetic navigation system by clicking on thevirtual buttons630,632,634, and636.Operating button630 causes the interface to operate the magnetic navigation system to the previous position in the pattern. Operating virtual button632 causes the interface to operate the magnetic navigation system to the next position in the pattern. Operating the virtual button634 causes the interface to operate the magnetic navigation system to successively move to each position in the pattern. Operating the virtual button634 stops automatic operation of the interface.

The colors of the representations of the new positions638 in the pattern preferably indicate the status of each position. For example, as shown inFIG. 27B, the dots638b-638hare a first color (e.g. light grey), indicating that the medical device has not yet been operated to those positions. The dot638ais a second color (e.g. yellow), indicating it is the current position of the medical device. As shown inFIG. 27C the dots638b-638hare in a first color, the dot638ais a second color and a dot of a third color (e.g. green) indicating the movement of the field appears behind dot638A. As shown inFIG. 27D, dot638ais a fourth color (e.g. dark grey) indicating that the medical device has already been navigated to the position, the dot638his not the second color, indicating it is the current position of the medical device, and dots638b-638gare the first color, indicating that the medical device still has not been navigated to these positions.

This pattern navigation, and automated pattern navigation, make it easy to navigate the medical device for selected procedures. For example in mapping procedures, wherein it is desirable to move a mapping catheter to trace an electrical signal, automated movement in a circular or spiral or other pattern facilitates the mapping procedure. Similarly, in ablation procedures, where the user needs to move the tip of an ablation catheter to form a closed loop of ablation, automated movement in a circular or other pattern facilitates the ablation procedure.

In operation the user can use the interface to operate a magnetic navigation system to apply a magnetic field in a selected direction in an operating region in a subject, to magnetically orient a medical device in the operating region. The user selects one of a plurality of predetermined patterns of new positions for the medical device using the selector320 and an input/output device, such as a mouse. The user then simply manually operates the magnetic navigation system to successively orient the medical device in each new position of the pattern by operating virtual button632 or initiate the system automatically moving from position to position after the predetermined delay by operating virtual button634.

A magnetic navigation system incorporating the interface may have one or more stationary electromagnetic coils, or one or more movable electromagnets and/or permanent magnets. The interface selectively powers the stationary electromagnets, selectively powers and moves the moveable electromagnets, or selectively moves the permanent magnets to apply the appropriate magnetic field at the operating point in the selected direction.

Another control of the interface of the third embodiment is illustrated inFIGS. 28 and 29. The control operates a magnetic navigation system that applies a magnetic field in a selected direction to an operating region in a subject to magnetically orient a medical device in the operating region. The control facilitates the specification for the direction in which to orient the medical device/apply a magnetic field.

The control comprises adisplay pane650 including anindicator652 for indicating the desired direction of the medical device and/or applied magnet field on a display. This indicator may be an arrow or other element capable of indicating a three-dimensional direction on a two-dimensional display. Thedisplay pane650 includes at least first and second

active areas

654 and656 for separately controlling theindicator652. An input device for controls a cursor or other indicator on the display pane to click and drag within one of the two active areas, to change the orientation of theindicator652. Clicking and dragging in the firstactive area654 rotates theindicator652 about an axis perpendicular to the plane of the display, and clicking and dragging in the secondactive area656 flattens in the indicator into the plane of the display, and rotates it about an axis perpendicular to the plane of the display. The input device is preferably a mouse, but could also be a joystick, space ball, touch screen or other device.

Theindicator652 is preferably surrounded by a closed shape, and wherein the firstactive area654 outside the closed shape, and wherein the secondactive area656 is inside the closed shape. In the preferred embodiment the closed shape is acircle658 which bounds the maximum extension of theindicator652. The circle preferably has a plurality of indicia around its circumference, and preferably twelve equally spaced indicia oriented like a clock face, for convenient reference by the users.

In a preferred implementation, there are preferably multiple panes showing the orientation of theindicator652 from different perspectives. As shown inFIGS. 28 and 29,

panes

660,662, and664 can be provided to provide an image of the indicator from three mutually perpendicular perspectives. Each of the panes allows for rotation of the indicator about an axis perpendicular to its particular plane. This, as described above, allows the user to adjust the orientation of theindicator652.

Theindicator652 inpane660 is surrounded by a circular frame666, defining a first active area668 outside the frame, and a secondactive area670 inside the frame. Clicking and dragging in first active area668 causes the indicator to rotate about an axis perpendicular to the plane ofpane652, while clicking and dragging in secondactive area670 causes the indicator to drop into the plane of thepane660, and rotate in that plane about an axis perpendicular to the plane of thepane660.

Theindicator652 inpane662 is surrounded by acircular frame672, defining a firstactive area674 outside the frame, and a secondactive area676 inside the frame. Clicking and dragging in firstactive area674 causes the indicator to rotate about an axis perpendicular to the plane ofpane652, while clicking and dragging in secondactive area676 causes the indicator to drop into the plane of thepane662, and rotate in that plane about an axis perpendicular to the plane of thepane662.

Theindicator652 in pane664 is surrounded by acircular frame678, defining a firstactive area680 outside the frame, and a secondactive area682 inside the frame. Clicking and dragging in firstactive area680 causes the indicator to rotate about an axis perpendicular to the plane of pane664, while clicking and dragging in secondactive area680 causes the indicator to drop into the plane of the pane664, and rotate in that plane about an axis perpendicular to the plane of the pane664.

In operation the interface is used to control a magnetic navigation system to apply a magnetic field in a selected direction in an operating region in a subject to magnetically orient a medical device in the operating region. The user selects the direction in which to apply a magnetic field by clicking and dragging on one of first and second active areas of a display to rotate an indicator indicating the desired direction. Clicking and dragging on the first active area rotating the indicator about an axis perpendicular to the plane of the display, and clicking and dragging on the second active area collapsing the indicator into the plane of the display, and rotating it about an axis perpendicular to the plane of the display. The user then operates the interface to cause the interface to apply a magnetic field to the operating region in the direction indicated by the indicator.

As shown inFIG. 3 this last control mode of navigation can be applied to specifying the field on the other panes. In this plane mode, a clock like circle is superposed over the indicator of the desired new direction. The indicator can be moved about an axis perpendicular to the clock face by clicking and dragging outside the clock face, or it can be moved in the plane of the clock face, also about an axis perpendicular to the clock face, by clicking and dragging inside the clock face.

A fourth embodiment of an interface in accordance with the principles of this invention is illustrated inFIGS. 32-48.

One possible embodiment of a main menu for display on the

monitors

72 and80 is indicated generally as700 inFIG. 32. Themenu700 has virtual buttons which the user can select and click using either themouse74 or84, or using the

joystick

76 or86. In this preferred embodiment there arebuttons702 for operating the interface in the basic mode,button704 for using the interface in an EP procedure;button106 for using the interface in and IC procedure, and abutton708 for using the interface during a CRT procedure. The menu preferably also hasbuttons710 for opening a previous procedure, abutton112 for importing a previous procedure, and abutton714 for exporting a previous procedure, and abutton716 for shutting down the system.

To enter the basic navigation mode of the interface, a user points the cursor at the “basic”button702, and clicking with the mouse or joystick. This action causes the basic navigation display, indicated generally as800 inFIG. 33, to be displayed on the monitors. As shown inFIG. 33, thedisplay800 preferably includes amenu bar802, which is preferably common to all screens, and which in this preferred embodiment has categories “Procedure”, “Navigation”, “Fluro”, “View”, “Volume”, “Settings”, and “Help”. Thedisplay800 preferably also includes amenu bar804, which is preferably common to all screens, and which in this preferred embodiment has astep selector box806, for selecting the increment size for changes in the direction of the applied magnetic field, and a magneticnavigation selector box808, for selecting between a “Manual Apply” mode in which the magnetic field must be manually applied after the magnetic field direction is selected, and an “Automatic” mode in which a magnetic field is automatically applied in the selected direction without further action by the user. There are also

format selection buttons

814 and816, for selecting the format of the display. In this preferred embodiment there are two formats, the first, selectable withbutton814 has two display panes surrounded by control panes at the left side and the top (for example as shown inFIG. 33), and the second, selectable withbutton816, has four display panes surrounded by control panes at the left and right sides (for example as shown inFIG. 34A). The user can select the type of display pane or control pane to display by right clicking in a particular area to display a menu, and selecting the particular type of display pane desired.

Anx-ray button818 can be operated to drop down a menu to select an x-ray image to display in an active x-ray image pane on the display. An x-ray transfer button820 can be operated to transfer new x-ray images from an x-ray imaging system to the interface, so that the new image can be selected whenx-ray button818 is operated.

Astore point button822 can be operated to store the current location of the distal end of the medical device being navigated with the user interface, using the Points & Constellation Pane as described below. Similarly a store vector button824 can be operated to store the current direction of the device (or in this preferred embodiment the current magnetic field direction applied to the device by the magnetic navigation system. There is avector window826 for displaying the status of the applied magnetic field. As a newly selected magnetic field is applied, an indicator in thewindow826 increases from 0% to 100% until the selected field is applied.

Thedisplay800 also includes various user-selected panes for displaying the current orientation of the medical device and for specifying a new desired location or orientation of the medical device. As shown inFIG. 33, these panes can include a 2Dfield specification pane828, a navigations pane830, apresets pane832, and abulls eye pane834. As described above, each of these panes can be replaced by right clicking on the pane to display a list of available alternative panes which can be selected. In this preferred embodiment, these panes can include a bull's eye pane, a points & constellations pane, a catheter adjustment pane, an alignment pane, and 2-D anatomical navigation pane. Of course thedisplay800 could include additional panes or fewer panes or different panes, including the various panes disclosed in the various other embodiments of this invention.

As also shown inFIG. 33, these panes also include two large panes, which can be anobject navigation pane836 and afield specification pane838, which displays one of the subpanes of the 2-Dfield specification pane828. As described above, each of these panes can be replaced by right clicking on the pane to display a list of available alternative panes which can be selected. In this preferred embodiment, these panes can include an object navigation pane, a 3D sync pane, a preoperative image pane, and an x-ray pane. Of course thedisplay800 could include additional panes or fewer panes or different panes, including the various panes disclosed in the various other embodiments of this invention.

The “Navigations” pane830 includes alist840 for entering a name or description of a stored direction; a store button842 for storing the current direction (similar to button824, described above); an edit button844 for editing the name or description of a previously stored navigation; a delete button846 for deleting a previously stored navigation; and areference box848 with a set button850 and a remove button852 for setting the color and id for a stored direction.

The “Presets”pane832 allows the user to quickly select directions from one or more sets of standard directions. The “Presets”pane832 has alist subpane854, with anicon column856, alist column858 for the name of one or more sets of standard or preset directions. The “Presets”pane832 also includes a directions subpane860, which displays the directions that are part of a selected set on thelist858. The directions subpane860 includes anID column862 and a description column864. TheID column862 contains a reference and a color code for each direction in the set, and the description column864 contains a name or description of each direction in the set.

The Bull'sEye pane834 comprises a generallycircular display screen868, and a plurality of buttons, including aset center button870, a show/hide button872, switch orientation button874, andscale menu876. In the preferred embodiment, theset center button870 centers the bull's eye grid on the current magnetic field direction, so that it is concentric with the indicator of the current magnetic field direction. In other embodiments of the user interface for use with other navigation systems, this button could center the bull's eye screen on the current direction of the medical device instead of the current magnetic field direction. The show/hide button872 toggles between a show mode in which the bulls eye grid is shown in the display panes in the interface, and a hide mode in which the bulls eye display is not shown in the display panes.

The switch orientation button874 changes the orientation of the bull's eye grid between the standard proximal to distal view and a distal toproximal view876. Thedisplay screen868 preferably has indicators for indicating the orientation of the display screen and the corresponding bull's eye grid. For example, as shown inFIG. 33, an indicator838a, which may be color coded (e.g. blue) is shown at the top of thecircular display screen838, and a corresponding indicator is shown on the bulls eye grid in the display panes, in the superior (up direction). A second indicator838b, which also may be color coded (e.g. red) is shown at the left side of thecircular display screen838, and a corresponding indicator is shown on the bull's eye grid in the display panes. The indicators838aand838bhelp the user to understand the relationship between thedisplay screen838 and the bull's eye grid in the user interface. Theswitch orientation button838 allows the user to switch the direction of the direction of thedisplay screen838 and the corresponding bull's eye grid in the display panes, from a perspective looking toward the distal end of the device, and the thus the indicator838bis on the left side of thedisplay screen838 and the corresponding bull's eye grid, and a perspective looking toward the proximal end of the device, and thus the indicator838bis on the right side of the display screen, and the corresponding bull's eye grid, reflecting the fact that the left side looking distally is the right side looking proximally.

Thescale orientation menu876 allows the user to set the scale of thedisplay838 and the bull's eye grid. In this preferred embodiment, the user can right click on themenu876, and select from one of several preset scales, preferably including 15°, 30°, 45°, 60° and 90°. The Bull's eye navigation pane can otherwise be used like the bull'seye navigation pane610 shown inFIG. 27, and described above. Thus, the Bull'sEye pane834 preferably also includes apattern navigation box880 for selecting a pattern of points and for manually or automatically navigating to the points in the selected pattern. Thispattern navigation box880 includes abox882 for activating pattern navigation, a selection box884 for selecting the shape of the pattern, a points selection box886 for selecting the number of points in the pattern, a range selection box888 for selecting the angular range of the pattern from the center point; and a pause selection box890 for selecting the duration of the pause between each navigation to a point in the automated pattern navigation mode. Acontrol bar892 has a first button894 for returning to the first point in the pattern, alast button896 for moving to the last point in the pattern, an advance button898 for advancing to the next point in the pattern, and a autoadvance button900 for automatically advancing through successive points, and a stop button902 for stopping the automatic advancement.

The interface preferably displays a visual indicator of the desired orientation for the distal end of the medical device, such as thearrow150, whose shaft is aligned with the desired orientation, with a large conical head pointing in the desired direction. Thearrow150 is preferably a distinctive color such as green. The interface preferably also displays a visual indicator of the current orientation of the distal end of the medical device, such asarrow152, whose shaft is aligned with the current orientation of the distal end of the medical device, with a larger conical head pointing in the desired direction. Thearrow152 is preferably a distinctive color such as yellow.

A localization system can be provided for determining the current position and orientation of the distal end of the medical device. An image representative of the distal end of the medical device can then be generated and displayed. There are numerous method for localizing the distal end of the medical device, for example transmitting magnetic or rf signals between the medical device and one or more reference locations, x-ray image processing, ultrasound localization, or electric potential localization.

In this preferred embodiment, the interface is adapted for use with a magnetic navigation system that operates by generating a magnetic field of selected direction in the operating region, which causes a magnetically responsive element associated with the distal end of the medical device to generally align with the applied magnetic field. Because of the physical properties of the medical device, limitations in the strength of the applied field, and the conditions in the procedure site, the distal end of the medical device may not align precisely with the applied magnetic field. While the difference between the applied magnetic field and the actual direction of the distal end of the medical device can be accounted for through modeling or a look-up table, in this preferred embodiment thearrow150 representing the desired orientation may represent the desired direction of the applied magnetic field, rather than the desired direction of the medical device itself. Similarly, thearrow152 representing the current orientation may represent the direction of the magnetic field currently being applied, rather than the actual direction of the device itself. However, the differences between the actual direction of the medical device and the applied magnetic field can be characterized by equation or an empirically determined look-up table, or localization of the device can be provided so that even when used with a magnetic navigation system, thearrow150 represents the actual desired orientation of the medical device, andarrow152 represents the actual current direction.

Other panes facilitate the visualization and selection of directions. One such pane to aid the user in selecting the desired orientation for the medical device is the 2-Danatomical pane828, which allows the user to select the desired direction (as indicated by the arrow150) by adjusting the direction of thearrow150 in one or more planes through the operating region in the subject. As shown inFIG. 33, thepane828 allows the user to change the direction of thearrow150 in at least one plane, and preferably at least two planes and more preferably at least the planes. These planes are preferably, but not necessarily, mutually perpendicular. While adjustment in two planes is sufficient to specify any direction, providing adjustment in three planes makes it easier for a user to select the desired direction for thearrow150. In this fourth preferred embodiment, thearrow150 can be rotated in the coronal or frontal plane (i.e., about an anterior-posterior axis), the median or saggital plane (i.e., about a horizontal axis), and the horizontal or transverse plane (i.e., about a longitudinal axis).

As shown inFIG. 33 thepane828 can have three

subpanes

910,912 and914, corresponding to the three planes of rotation.Subpane910 contains a graphic depiction of the coronal or frontal plane (i.e., a caricature image of a subject's body in the coronal or frontal plane), with anindicator916 that indicates the orientation of the arrow in the coronal or frontal plane, andvirtual buttons918 and920 for moving the indicator916 (and thus the arrow150) clockwise or counterclockwise in the coronal or frontal plane abut the anterior-posterior axis. In this fourth preferred embodiment,indicator916 is actually a projection of thearrow150 in the plane, and thus the length of theindicator916 is indicative of the orientation. Thevirtual buttons918 and920 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click the button and move theindicator916 and thus thearrow150, in the desired direction.

Subpane

912 contains a graphic depiction of the median or saggital plane (i.e., a caricature image of a subject's body in the median or saggital plane), with anindicator922 indicating the direction of thearrow150 in the median or saggital plane, andvirtual buttons924 and926 for moving the indicator922 (and thus the arrow150) clockwise or counterclockwise in the coronal or frontal plane. In this first preferred embodiment,indicator922 is actually a projection of thearrow150 in the plane, and thus the length of theindicator922 is indicative of the orientation. Thevirtual buttons924 and926 can be operated with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click and move theindicator922 and thus thearrow150, in the desired direction.

Thepane914 contains a graphic depiction of the horizontal or transverse plane (i.e., a caricature image of a subject's body in the horizontal or transverse plane), with anindicator928 indicating the direction of the arrow in the horizontal or transverse plane, andvirtual buttons930 and932 for moving the indicator178 (and thus the arrow150) clockwise or counterclockwise in the horizontal or transverse plane. Thevirtual buttons930 and932 can be operated with a cursor for example with the

mouse

58 or66 or thekeyboard64, to point and click to move theindicator928, and thus thearrow150 in the desired direction.

As described above, themenu bar804 contains astep selector box806 to select the increment of change in direction upon operating the

buttons

918 and920,924 and926, and930 and932. The user can preferably select the incremental change from several preset increments: 1 degree, 2 degrees, 3 degrees, 5 degrees, 10 degrees with a cursor for example with the

mouse

74 or82 or thekeyboard80, to point and click to select the desired increment.

Theobject navigation pane836 has arepresentation940 of a three-dimensional object. This three dimensional object is preferably a sphere, but it could be some other shape such as an ellipse or a cube. There are preferably indicators on the surface of the three dimensional object to indicate the corresponding directions in the operating region in the subject. In this preferred embodiment, these indicators include cones942 for identifying the directions of major anatomical axes in the subject. As shown inFIG. 33, there are a pair of cones942A identifying the superior-inferior axis, a pair of cones942B identifying the anterior-posterior axis, and a pair of cones942C identifying the left-lateral right-lateral axis. Each of the pairs of cones942A,942B, and942C, are preferably displayed in a unique color. There are preferably a plurality of latitude lines and longitude lines on the surface of the three-dimensional object. In this preferred embodiment, the latitude lines and longitude lines for each axis are color coordinated with the color of the cones, and preferably can be selectively displayed or hidden.

The indicators can also include direction indicators944 for identifying other selected directions in the operating region in the subject on the surface of the three dimensional object. As shown inFIG. 33, these indicators944 can include anindicator944A indicating the RAO direction and an indicator944B indicating the LAO direction. The cone pairs942A,942B, and942C, and theindicators944A and944B, indicate the preset cardinal directions as set forth on thePresets pane832.

The indicators can also include a representation of at least a portion of the subject, such asrepresentation946. This representation can be an idealized representation of a subject. Alternatively, this representation could be created from actual image data of the subject. Of course the representation could also be a representation of an internal body structure. This representation could either be an idealized representation of the internal body structure, or it could be a representation created with imaging data from the subject. Each point on the surface of therepresentation940 of the object corresponds to a direction in the operating region. The user clicks on a location on the surface of therepresentation940 of the object to identify the desired direction of orientation in the operating region. The indicators942 and944, and therepresentation946 help the user identify the point on the surface of the representation of theobject940 that corresponds to the desired direction.

Theobject navigation pane836 has a rotation button948, a spherical/hemispherical button950, a 3D sync button952, and a view selection window954. The rotation button948 toggles between a rotation mode in which the cursor can be manipulated by a control device such as mouse, joystick, or keyboard to grab and rotate therepresentation940 of the object, and a selection mode in which the cursor can be manipulated by a control device such as a mouse, joystick, or keyboard, to select a point of the surface of therepresentation940 of the object.

The spherical/hemispherical button950 toggles between an external view of therepresentation940 of the object, and an internal view of the representation of the object, which is preferably taken from a vertical plane through the center of rotation of the object.

The 3D sync button952 preferably synchronizes rotation of a 3D representation of the operating region with the rotation of therepresentation940 of the object in theobject navigation pane838.

A floating “Fluro” tool bar956 can be made to appear on the interface display, and has a contrast/brightness button958, a pan button960, and a vector show/hide button962. The contrast/brightness button958 displays a menus allowing the user to adjust the contrast and the brightness of the fluoro display pane (which is not shown ifFIG. 33). The pan button960 allows the user to pan over the x-ray image displayed in the fluoro display pane. The vector show/hide button962 can be operated by the user to selectively show or hide the direction vectors, e.g. thecurrent direction vector150 and the desirednew direction vector152.

A floating “Mode” window964 can also be made to appear on the interface display, and has a vector mode button966, an x-ray mode button968, a target mode button968, an a vessel navigation mode button972. The vector mode button966 causes the active display panes to enter the vector mode in which the directions are displayed and specified on the panes. The x-ray mode button968 permits field adjustments to be made in the plane of the selected reference X-ray window. The target mode button968 causes the active display panes to enter the target mode, where target points are identified rather than navigation directions. The vessel navigation button can be used to set the local tangent at a location along a vessel constellation (defined by an automatic spline curve fitting to a group of fluoro-localized points along a vessel) by double-clicking at that location on the vessel constellation in the 3D window.

A display from the EP mode of the fourth preferred embodiment of a user interface is indicated as1000 inFIG. 34. The display is reached by clicking onbutton704 on themenu700. Thedisplay1000 comprises a 2Dfield specification pane1002, similar topane828 described above. Thedisplay1000 also comprises a “Points & Constellation”pane1004, a “Presets” pane1006 similar to “Presets”pane832 described above, an “Alignment”pane1008, and a “Catheter Adjustment Tools”pane1110. Thedisplay1000 also includes a 3-D view pane1012, ananatomical model pane1014, anx-ray display pane1016, and an object navigation pane1018 similar to theobject navigation pane836.

Using the various navigation tools of the interface, the user can navigate the distal end of a medical device to selected points in the operating region, and assemble these points in groups or constellations. The user can use the “Points & Constellations”pane1004 to select how these points are displayed in the various panes of the user interface. As shown inFIG. 34, the “Points & Constellations”pane1004 has asubpane1020 with acolumn1022 for selecting how the point or constellation is displayed on the panels of thedisplay1000; acolumn1024 for indicating a color code for displaying the point or group of points, and a code for indicating from which panes the points were created, acolumn1026 for displaying a name of the point or group of points; acolumn1028 for selecting whether to display the point or group of points on anx-ray display pane1016, and acolumn1030 for selecting whether to display the point or group of points on the 3D display1012. When a particular point or group of points on thesubpane1020 is selected, the member points are displayed insubpane1032, which has acolumn1034 for an ID of the point and acolumn1036 for a name of the point.

Thecolumn1022 allows the user to select how the points in a group are displayed in the 3-D pane1012. The user can select (for example by right clicking with the mouse or some similar command) to display the points as a group. The user can also select to display a group of points as a computer generated spline (a closed loop that best fits the point or points selected. (SeeFIG. 35). The user can also select to display a group of points as a computer generated planar disk, such asdisks1038 in pane1012, which are particularly well suited for displaying ostium or openings in a surface that have been identified by a plurality of points. The interface generates a closed loop ofactive points1036 from a set of selected points, and generates a disk of active points surrounding the loop in the same general plane. (SeeFIG. 36). The user can easily select a point on theloop1036 or on thedisk1038, and the interface allows the user to make the medical device to point toward the selected point. The user can also select to display the points as asurface patch1039, comprising a surface between the points in the group. (SeeFIG. 37).

The user can also cause the points to be displayed in thex-ray image pane1016, by checking the appropriate box incolumn1028 of thesubpane1032 As shown inFIGS. 34A and 34B, the groups are indicated as splines superposed over the x-ray image in thepane1016, in the color indicated incolumn1024 for the group to which each point belongs.

The pane1012 has apan button1040, a 3D grid show/hide button1042, apoint selection button1044, a direction selection button1046, a bulls eye button1048, a first user defined view_button1050, a second user defined view button1052, a third user defined view button1054, and a view selection window1056. Thepan button1040 allows the user to select a mode in which the movement of the cursor, for example with the mouse, joystick, or keyboard, allows the user to pan across the view in the pane1012. Thepoint selection button1044 allows the user to select a point in the pane1012. The direction selection button1046 allows the user to select a direction in the pane1012. The bulls eye button1048 causes the bull's eye grid to be displayed on the pane1012. The first, second, and third user defined view buttons1050,1052, and1054 allows the user to save up to three separate user defined views, so that the user can quickly and easily return to those views. The view selection window1056 allows the user to select one of several standard views in the pane1012.

The object navigation pane1018 is similar to theobject navigation pane836 ondisplay800, and includes arepresentation1058 of a three dimensional object. As described above with respect to object940, the three dimensional object depicted byrepresentation1058 is preferably a sphere, but it could be some other shape such as an ellipse or a cube. There are preferably indicators on the surface of therepresentation1058 of the three dimensional object to indicate the corresponding directions in the operating region in the subject. In this preferred embodiment, these indicators include cones1060 for identifying the directions of major anatomical axes in the subject. As shown inFIGS. 34A and 34B, there are a pair of cones1060A identifying the superior-inferior axis, a pair of cones1060B identifying the anterior-posterior axis, and a pair of cones1060C identifying the left-lateral right-lateral axis. Each of the pairs of cones1060A,1060B, and1060C, are preferably displayed in a unique color. There are preferably a plurality of latitude lines and longitude lines on the surface of the three-dimensional shape. In this preferred embodiment, the latitude lines and longitude lines for each axis are color coordinated with the color of the cones, and preferably can be selectively displayed or hidden.

The indicators can also includedirection indicators1062 for identifying other selected directions in the operating region in the subject on the surface of the three dimensional object. As shown inFIGS. 34A and 34B, theseindicators1062 can include an indicators for the various preset directions for the selected set of directions in “Presets” pane1006. The “Presets” pane1006 is similar to the “Presets”pane832 described above. The cone pairs1060A,1060B, and1060C, and theindicators1062 help the user select the appropriate point on the surface of therepresentation1058 of the object to properly identify the desired corresponding direction in the operating region in the subject.

The indicators can also include a representation of at least a portion of the subject, such asrepresentation1064. Thisrepresentation1064 can be an idealized representation of the internal body structures in the operating region in the subject. Alternatively, thisrepresentation1064 could be created from actual image data of the operating region in the subject. Of course the representation could also be a representation of an external body structure, as described above with respect topane836 ofdisplay800.

The object navigation pane1018 is particularly adapted for direction based navigation, rather than point based navigation, although it could be used in point based navigation. Each point on the surface of therepresentation1058 of the object corresponds to a direction in the operating region. The user simply manipulates a cursor to the desired position and clicks on the location on the surface of the representation of the object to identify the desired direction in the operating region in the subject. Theindicators1060 and1062, and therepresentation1064 help the user identify the point on the surface of therepresentation1058 of the object that corresponds to the desired direction.

Other directional markers are preferably provided on the surface of theobject1058. For example, the various system-specified and user-specified preset directions can be stored by the interface. The “Presets” pane1006 is similar toPresets pane832, and corresponding parts are identified with corresponding reference numerals. The “Presets” pane has a “List” subpane854, and a “Directions”subpane860. Thelist subpane854 has acolumn856 for icons indicating the type of set of directions, and aname column858 for indicating the name of the direction. For a selected set of directions on theList subpane854, the “Directions”subpane860 displays the various directions that comprise the set. The “Directions”subpane860 has anID column862 which displays an ID code and a color code for each direction, These directions are in turn displayed on theobject1058 usingindicators1062 with corresponding ID codes and colors. Theseindicators1062 help the user select a point on the surface of theobject1058 that corresponds to the desired direction in the operating region, including picking one of the preset directions.

The interface is preferably provided with a variety of present directions that users can employ to orient the medical device. For example standard directions from the center of the operating region, or from a particular entrance of an operating region, to common procedure destinations for typical anatomies can be determined, and these directions stored, so that when a user desires to navigate to one of these common destinations, the user merely needs to select from among the standard directions. For example, as shown inFIGS. 34A and 34B, standardized directions to the center of the mitral center, the 3 o'clock position on the mitral valve, the six o'clock position on the mitral valve, and the 12 o'clock position are all indicated by markers on theobject1058. These marks are color coordinated with theID column862 in the “Directions”subpane860, and each is identified with the code appearing in theID column862.

The user can select a direction by pointing a cursor and clicking on the surface at the point corresponding to the desired direction. In this preferred embodiment which includes a magnetic navigation system, the magnetic navigation system is then applied, for example by clicking on the applymagnetic field button1066. Depending upon how the system is set up, the system may either apply a magnetic field in the selected direction, or it may apply a magnetic field that will cause the device to point in the desired direction. Alternatively, in the continuous mode, the magnetic navigation system can automatically act to orient the device in the desired direction. When used with non-magnetic navigation system, the selected direction can be input to the control of the non-magnetic navigation system, which can then orient the medical device in the desired direction.

The pane1018 includes an orientation button1068, a full-sphere/half-sphere button1070, a 3D sync button1072, and a window1074. The orientation button1068 causes the display to enter the pivot mode where the user can uses the controls (e.g. the cursor under the control of the mouse or joystick), to rotate theobject1058. Theobject1058 preferably pivots about its center, but it could pivot about some other point, if desired. The full-sphere/half-sphere button1070 toggles between a full-sphere view in which theentire object1058 is visible (for example,FIG. 34A), and a half-sphere view in which the front half of theobject1058 is removed, and the rear half is visible from the inside (for exampleFIG. 34B). The 3D sync button1072 synchronizes the object navigation pane1018 with the 3D display pane1012, so that rotation of the representation of theobject1058 rotates that 3d display pane1012. The window1074 allows the user to select among one of several standard views.

The interface can also employ a CatheterAdjustment Tool pane1010, which has anangle adjustment box1076, and aposition adjustment box1078, and aposition adjustment box1080. As shown inFIG. 38, in theangle adjustment box1076, the user can specify an angle of catheter over-torque, i.e., an angular adjustment beyond what is necessary to contact the surface, to increase the contact force between the catheter and an anatomical structure in the operating region. Thebox1076 includes an indicator window1082 for displaying the angle of over-torque, and increase and decrease

buttons

1084 and1086 for increasing and decreasing the angle of over-torque, and aslide control1088 for alternatively specifying the angle of overtorque. Abutton1112 can be provided to reset the over-torque to zero.

Theposition adjustment box1080 includes controls for displaying and operating a distance adjustment tool. The box is used in conjunction with a display of a representation1081 of the distal end of the medical to adjust the configuration of the representation of the distal end of a medical device to a desired configuration, and then cause the actual medical device to conform to the configuration of the representation of the medical device. The representation1081 is preferably derived from a computational model of the actual medical device, as is discussed in U.S. patent application Ser. No. 10/448,273, filed May 29, 2003, forRemote Control of Medical Devices Using a Virtual Device Interface, U.S. Patent Application 20040068173 published Apr. 8, 2004, the entire disclosure of which is incorporated herein by reference.

Thebox1080 includes a button1118 for displaying a catheter adjustment indicator or reticle1120 (shown inFIG. 39), in the 3D view pane (e.g., panes1012 inFIGS. 34A and 34b). In this preferred embodiment thereticle1120 comprises a series of concentric rings (hexagonal in this preferred embodiment) with a perpendicular line extending through its center point, although the active area of adjustment is really an umbrella-shaped surface that includes the displayed rings. Thereticle1120 is displayed at a point selected by the user. If the point selected by the user (for example by pointing a cursor and clicking) is not on a surface, thereticle1120 is preferably displayed centered at the distal tip of the representation of the medical device, in an orientation perpendicular to the orientation of the distal end of the medical device. If the point selected by the user is on a surface, the center of thereticle1120 is preferably positioned on a line normal to the surface point at a default distance from the surface selected by the user. This default distance may be zero to position thereticle1120 at the surface, or it may be a positive distance to position thereticle1120 beyond the surface, or a negative distance to position the reticle short of the surface. In this preferred embodiment, the user can also specify that the reticle be displayed in the plane of the display at the selected point by usingbutton1116.

The position of thereticle1120 and thus the position of the representation of the distal end of the medical device, which follows the reticle, can be adjusted to achieve a desired position or configuration of the representation of the medical device. Once the desired position or configuration is achieve, the navigation system can be operated to cause the actual medical device to conform to the representation. Alternatively, the navigation system could automatically operate to cause the actual medical device to conform to the representation of the medical device as changes are made to the representation.

The box includes anindicator1098 which indicates the distance between the reticle1120 (and the distal end of the medical device being controlled with the interface), and the starting point. Where an offset from the surface is specified, this offset is automatically displayed in theindicator1098. Further movement of thereticle1120 is reflected in theindicator1098. Buttons1100 and1102 allow the user to selectively increase or decrease the distance between thereticle1120 and the representation of distal end of the medical device) and the starting point. Thebox1080 can also include aslide control1104 for selecting the distance (+ or −) of thereticle1120 and the representation of the distal portion of the elongate medical device and the starting point, increasing and decreasing the distance between the reticle and the starting point, and thereby changing the configuration of the representation of the distal end of the medical device. This distance can be either negative indicating that the desired destination point is inside of the starting point, or the distance can be positive indicating that the desired destination point is outside starting point.

As shown inFIG. 38, thebox1080 can also include a surfacepersistent box1106. When the user selects the surfacepersistent box1106, theindicator1120 remains at its current location even if the distal tip of the medical device moves. Astore button1108 stores the location of theindicator1120, and therecall button1110 recalls the location of theindicator1120. This facilitates returning to a previously navigated location.

As shown inFIG. 38, thebox1078 can have awindow1090 indicating the change in length of the elongate medical device to reach the destination point represented by the reticle. The window indicates amount of the change, and increase and

decrease indicators

1092 and1094 indicate the direction of change (i.e. whether the length needs to be increased or decreased) to bring the distal end of the actual device to the point indicated by the representation of the distal end of the medical device on thereticle1120. When the free length of the medical device needs to be increased to reach the position in the operating region corresponding to the position represented by the representation of the medical device on thereticle1120, theincrease indicator1092 is activated, and when the free length of the medical device needs to be decreased to reach the position in the operating region corresponding to the position represented by the representation of the medical device on thereticle1120 indicator, thedecrease indicator1094 is activated. Thebox1078 also includes areset button1096 to reset thewindow1090.

By adjusting the position of thereticle1120 along the line1122, and by adjusting the position of the representation of the medical device relative to the surface of the reticle, the user can accurately make minor adjustments in the position and configuration of the actual device. Once the desired configuration of the medical device is correctly indicated in the display, the user can then apply the configuration. In this preferred embodiment employing a magnetic navigation system, the user simply click the apply field button and the navigation system orients the actual device in the direction required to reach the target point indicated on the display. The user then advances or retracts the device as indicated on the indicators1090-1094, to bring the medical device to the desired destination. With other navigation systems, the system could be operated to orient the distal end portion in the appropriate configuration, and the device advanced. In this manner the distal end of the device can be easily advanced into a lumen, or pressed against a wall of an anatomical structure.

It is possible that the movement of the distal end of the device could be automated as well as the orientation of the distal end. Feedback from a localization system could also be incorporated to facilitate the automation of the orientation and movement of the distal end of the device.

Thedisplay1000 also includes ananatomical pane1014, with arepresentation1126 of a three-dimensional anatomical feature, obtained from imaging data from the subject. Each point on the surface of the representation corresponds to a location in the operating region. Theanatomical pane1014 has apan button1128, a show/hide objects button1130, acenter point button1132, a fit-objects-to-window button1134, aview synchronization button1136, atransparency selection button1138, aTissue Editor button1140, and a “Share Fluoro Points”button1142. Thepan button1128 allows the user to use the cursor to click and drag the display in the pane, for example with the mouse, joystick, or keyboar to change the view. With a mouse click on this button, a toolbar of other choices for the mouse mode (such as rotation) can also be brought up to change the mouse mode if desired. The show/hide objects button1130 allows the user to display objects such as the points selected on the surface of therepresentation1126 of the three dimensional anatomical feature, within theanatomical window pane1014. Thecenter point button1132 centers the display on thepane1014 on a selected point. The fit-objects-to-window button1134 rescales the display scale within the window so that all objects are visibly displayed in thepane1014. Theview synchronization button1136 synchronizes the display perspective in thepane1014 to that of the display selected with this button, for example that of the bull's eye display. Thetransparency selection button1138 allows for a choice of opaque, semi-transparent or transparent display of the three dimensional image displayed in thepane1014. TheTissue Editor button1140 brings up a choice of colors, shades and transfer functions for the data that may be chosen by a user to display the three dimensional image data in customized form. The “Share Fluoro Points”button1142 permits display of fluoro-localized points in thepane1014 after a suitable registration between preoperative image data and the X-ray or navigation system has been effected, in a manner similar to that described herein.

Thepane1014 also includes a window1144. The window1144 allows the user to selected one of several standard views.

Once the three dimensional image data has been registered to the navigation system, the user can manipulate therepresentation1126 and select a target by picking a point on the surface of the representation. As also shown inFIG. 34A, the user can also employ the distance adjustment tool to advance and retract the medical device along a line normal to the surface of a selected target point.

Thealignment pane1008 can be used to align or register the 3D image inpane1014 with the x-ray image inpane1016. As best shown inFIGS. 49A and 49B, the alignment pane has tabs to select between an auto (automatic) mode (FIG. 49A) and a manual mode (FIG. 49B). In the automatic mode shown inFIG. 49A, the pane has afluoro point box1200, with anID column1202 and aname column1204, and apreop point box1206 with anID column1208 and aname column1210. In the auto mode,pane1008 also includes an “Add Selected Points”button1212, and “Adjust”button1214, and a “Reset All”button1216. The user selects point from the Points &Constellations pane1004. The user picks a group fromcolumn1026, and then selects one or more of the points in the group that are displayed onlist1036. Once a point has been selected, the point can be added to one of the lists (1202 or1206) with the Add SelectedPoints button1212. The user tries to mark the same points on both the anatomical display and the fluoro display. In the case of an EP procedure, an effective technique is to identify the highest (most superior) point in two or more of the pulmonary veins in each display. Once an appropriate number of corresponding points have been identified in both the anatomical and the x-ray views, the user can use the Adjustbutton1024 to automatically find the best fit between the anatomical and x-ray views. If the match is not satisfactory (i.e. if the corresponding points from the x-ray view and the anatomical view are not satisfactorily aligned), the user can reset the points and start over with the Reset Allbutton1216. Alignment with thepane1008 allows points and directions identified on the anatomical model to be displayed and used on the x-ray view, and vice versa. Thus the indicators in

columns

1028 and1030 inpane1032 can be checked to display fluoro points, not just on thex-ray pane1016, but also on theanatomical pane1014, and to display anatomical points, not just on theanatomical pane1016 but also on thex-ray pane1016. As shown inFIG. 34A, the set of fluoro points indicated by yellow circles in theanatomical pane1014 and the set of preoperative points indicated by red squares in theanatomical pane1014 are fairly well aligned.

The automatic best fit alignment or registration can be implemented as a cost function optimization procedure. Since preoperative image points are being registered to X-ray or fluoro-localized points, a natural measure or cost function is the sum of the squared distances between corresponding points after a rigid transformation has been applied to one set of points, say the preoperative image points. The rigid transformation in general consists of a rotation and a translation. Standard algorithms such as the so-called Procrustes method can be used for this purpose. In some cases the three dimensional image data may not require further orientational corrections, in which case only a best-fit translation is required to implement the registration. In this latter case it can be mathematically shown that a best-fit registration is achieved by matching the centroids of the 2 sets of points (the preoperative image set and the fluoro-localized set); thus the distance vector between the corresponding centroids defines the requisite translation. Thus the “Adjust”button1024 could implement any of these schemes. Other intensity-based schemes familiar to those skilled in the art could also be used for the automatic registration process.

As shown inFIG. 49B, in the manual mode thepane1008, has an adjustbox1220 with an “All”pick button1222, a “Fluoro” pick button1224, a “Preop” pick button1226. Thepane1008 also has a “Fluoro A” button1228 and a “Fluoro B”button1230. The user can select the “Fluoro” pick button1228, and then move the fluoro points displayed on the preoperative anatomical image inpane1014. The user can also select the “Preop” pick button1224, and then move the preop points displayed on the x-ray fluoroscopic image inpane1016. Finally the user can select the “All” button, and then move the preop points displayed on the x-ray fluoroscopic image inpane1016 and/or the fluoro points displayed on the preoperative anatomical image inpane1014. The user can use the Fluoro A andFluoro B buttons1228 and1230, which preferably display thumbnail images, to switch the image that user uses to align with the preoperative image points.

FIG. 34B is a view of thedisplay1000 similar to the view inFIG. 34A, except that the button1070 has been pressed to displayobject1058 cut in half by a plane in order to display the interior rather than the exterior of the object. Theobject1058 has also been rotated slightly inFIG. 34B fromFIG. 34A. As shown in pane1018 inFIG. 34B, the inside view is preferably taken along a vertical plane through the point of rotation of theobject1058. The outside of theobject1058 is shown inFIG. 40, the inside of the object1058 (rotated fromFIG. 40) is shown inFIG. 41, and the standard user directions, several user selected directions, and the desired field direction are shown in the enlarged inside view of the object inFIG. 42.

FIG. 43A is another view of thedisplay1000 configured by the user withbutton814, and selecting2D Pane1002, Navigations pane1250, Presets pane1006, and Bull'sEye pane834. The user has also selected the object navigation pane1018, and the 30° LAO subpane from the2D pane1002. In the object navigations pane, the user has selected (for example by right clicking on therepresentation1058 of the object) to display a representation of the right atrium inside therepresentation1058 of the object.

The Navigations pane1250 is adapted for storing and displaying defined directions. As shown inFIG. 43A, the Navigations pane1250 includes a “Navigations” list1252 for listing various user defined directions. The Navigations pane1250 also includes a “Store” button1254, an “Edit” button1256, and a “Delete” button1258. In this preferred embodiment, the Store button1254 stores the current direction of the magnetic field, although when used with a non-magnetic navigation system it might simply store the current direction of the medical device. The Edit button allows the user to edit the name of a previously stored point on the Navigations list1252. The Navigations pane1250 also includes a “Reference” box1260. The navigations box1260 has two indicator windows1262 and1264 for setting identifying information about a stored user-defined direction. For example, the user can right click on the window to1262 and1264 to select color and shape, respectively, or the windows1262 and1264 could be set up to receive text labels entered, for example with a keyboard. The reference box1260 also includes a “Set” button1266 to set the selected identifiers in the windows1262 and1264 for a selected direction highlighted on the Navigations list1252. The reference box1260 preferably also includes a “Remove” button to remove the identifiers for a selected direction highlighted on the Navigations list1252.

The Bull'sEye pane834 is adapted for manually or automatically adjusting the distal tip of the medical device.

FIG. 43B is a view similar toFIG. 43A, except that the sphere/hemisphere button has been operated inFIG. 43B to show the interior ofobject1058, and the object has been rotated.

FIG. 44 is another view of thedisplay1000 configured by the user withbutton814, and selecting2D Pane1002, Navigations pane1250, Presets pane1006, and Bull'sEye pane834. The user has also selected the object navigation pane1018, and the 30° LAO subpane from the2D pane1002. In the object navigations pane1018, the user has selected (for example by right clicking on therepresentation1058 of the object) to display a representation of the entire heart inside the representation of the object.

The Navigations pane1250 is adapted for storing and displaying user-defined directions. The Presets pane1006 is adapted for recalling various preset directions and sets of directions. The Bull'sEye pane834 is adapted for manually pr automatically adjusting the distal tip of the medical device.

FIG. 45A is another view of thedisplay1000 configured by the user withbutton814, and selecting2D Pane1002, Navigations pane1250, Presets pane1006, and Bull'sEye pane834. The user has also selected the object navigation pane1018, and the 30° RAO subpane from the2D pane1002. In the object navigations pane1018, the user has selected (for example by right clicking on therepresentation1058 of the object) to display a representation of the left atrium inside the representation of the object.

The Navigations pane1250 is adapted for storing and displaying defined directions. The Presets pane1006 is adapted for recalling various preset directions and sets of directions. The Bull'sEye pane834 is adapted for manually or automatically adjusting the distal tip of the medical device.

FIG. 45B is a view similar toFIG. 45A, except that the sphere/hemisphere button has been operated inFIG. 45B to show the interior of therepresentation1058 of the object, and the object is shown rotated.

FIG. 46 is a view of a display1300 from the CRT mode of the preferred embodiment of the user interface, selected by operatingbutton708 on themenu700 inFIG. 32. The display1300 is similar to thedisplay1000 and corresponding parts are identified with corresponding reference numerals. The user has configured the display1300 withbutton814, and selecting2D Pane1002, Navigations pane1252, Presets pane1006, and Bull'sEye pane834. The user has also selected the object navigation pane1018, and the 30° LAO subpane from the2D pane1002. In the object navigations pane1018, the user has selected (for example by right clicking on therepresentation1058 of the object) to display a representation of the right atrium inside therepresentation1058 of the object.

FIG. 47 is a view of a display1300 from the CRT mode of the preferred embodiment of the user interface, selected by operatingbutton708 on themenu700 inFIG. 32. The display1300 is similar to thedisplay1000 and corresponding parts are identified with corresponding reference numerals. The user has configured the display1300 withbutton816, and selecting2D Pane1002, “Points & Constellations”pane1004, Presets pane1006, Bull'sEye pane834, and Navigations pane1250. The user has also selected the 3D pane1012, the preoperative anatomical pane1014 (which inFIG. 47 shows the venous structure of the heart), and twofluoro panes1066 to display the RAO and LAO images of the operating region.

As shown inFIG. 47, a vessel grouping is also possible in the Points andConstellations pane1004. In the vessel grouping a series of points are joined as a continuous path, as a blood vessel. The user can use

columns

1028 and1030 to elect to display the vessel grouping on the images in thefluoro panes1066, and on the 3D pane1012. As shown inFIG. 47, a vessel grouping1400 is displayed in bothfluoro panes1066, and in the 3D pane1012. The user can pick a direction parallel to the longitudinal axis of the vessel grouping simply by selecting a point on the vessel grouping. This is useful in navigating through vessels. As shown inFIG. 47, the Bull'sEye pane834 is in use so that the user can conveniently alter the indicated desired direction from the tangential direction to the vessel grouping.

FIG. 48A is a view of the display of an anatomicalobject navigation pane1014. The user can identify points on the surface of theanatomical object1126 by manipulating the object and pointing and clicking on points on its surface. These points can be grouped as constellations, for example splines,1402,1404,1404, and displayed on a 3D pane1012. This facilitates visualization of the points selected directly from subject-derived anatomy.

While discussed above with respect to controlling a magnetic navigation system, it should be understood that any of the interfaces described above can be used to control any system for remotely orienting the distal end of an elongate device, including but not limited to medical devices such as catheters and guide wires.