METHODS ASSOCIATED WITH MRI SURGICAL SYSTEMS FOR REAL-TIME VISUALIZATIONS USING MRI IMAGE DATA AND PREDEFINED DATA OF SURGICAL TOOLS

• US 20130006095A1
• Filed: 09/11/2012
• Published: 01/03/2013
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc., Mdesign & Product Development, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Jenkins, Kimble, Piferi, Peter, Hotte, Philip Bradley, Farberov, Pavel, Orr, Timothy Neil, Geiger, Paul Arthur, Sayler, David John
• Granted Patent: US 9,314,305 B2
• Time in Patent Office: Days
• US Class Current: 600/411
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61B 2034/101 Computer-aided simulation of surgical operations
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 34/74 Manipulators with manual electric input means
• CPC Class Codes: A61B 5/0042 for the brain
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/14 : Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/96 : using barcodes
• CPC Class Codes: G01R 33/286 : involving passive visualization of interventional instruments, i.e. making the instrument visible as part of the normal MR process
• CPC Class Codes: G01R 33/3415 : comprising arrays of sub-coils , i.e. phased-array coils with flexible receiver channels
• CPC Class Codes: G01R 33/546 : Interface between the MR system and the user, e.g. for controlling the operation of the MR system or for the design of pulse sequences

Abstract

MRI-Surgical systems include: (a) at least one MRI-compatible surgical tool; (b) a circuit adapted to communicate with an MRI scanner; and (c) at least one display in communication with the circuit. The circuit electronically recognizes predefined physical characteristics of the at least one tool to automatically segment MR image data provided by the MRI scanner whereby the at least one tool constitutes a point of interface with the system. The circuit is configured to provide a User Interface that defines workflow progression for an MRI-guided surgical procedure and allows a user to select steps in the workflow, and wherein the circuit is configured to generate multi-dimensional visualizations using the predefined data of the at least one tool and data from MRI images of the patient in substantially real time during the surgical procedure.

Claims

1. A method for carrying out an MRI-guided surgical procedure, comprising;

obtaining MRI image data of a patient;

electronically segmenting the MRI image data to identify known fiducial markers on at least one surgical tool using electronically recognizable predefined physical characteristics of the at least one surgical tool;

electronically calculating user adjustments to move at least one of a pitch, roll and/or X-Y actuator to adjust a trajectory of a trajectory guide; and

displaying the calculated user adjustments to at least one display associated with an MRI suite thereby facilitating an MRI-guided surgical procedure.

2. The method of claim 1, further comprising providing a User Interface on the at least one display that includes a series of selectable workflow groups including “

start”

, “

plan entry”

, “

plan target”

, “

navigate”

, and “

refine”

that can be used to guide a surgical procedure resulting in delivering a therapy after the “

refine”

workflow group.

3. The method of claim 1, further comprising displaying fMRI patient function on the at least one display associated with an MRI suite with active regions of a brain in response to a defined stimulation in substantially real-time.

4. The method of claim 1, further comprising selectively displaying brain fiber tracks of the patient in visualizations on the at least one display.

5. The method of claim 1, wherein the pitch, roll, X and Y actuators are controlled by user input devices on a control member that is located away from the actuators, and wherein the user input devices on the control member are each separately attached to a respective actuator by a length of cable, wherein the electronically calculating comprises calculating associated adjustments for the user input devices to adjust the X, Y, pitch and roll actuators to provide a selected trajectory path, the method further comprising displaying instructions to the at least one display as to which user input devices need to be turned and in what direction to achieve the selected trajectory path.

6. The method of claim 1, wherein the electronically segmenting the MRI image data is carried out by electronically interrogating image data and identifying predefined physical characteristics of the at least one tool whereby the at least one tool constitutes a point of interface with an MRI-guided surgical system.

7. The method of claim 1, wherein the MRI guided procedure is a deep brain procedure, wherein the trajectory guide is attached to a skull of the patient, and the MRI image data is from brain MRI images, wherein the at least one surgical tool comprises a flexible grid attached to a skull of the patient, and wherein the method further comprises electronically deforming an electronic model of the grid to fit a head surface and interpolating grid cells of the grid to find associated vertices.

8. The method of claim 1, wherein the trajectory guide comprise a plurality of spaced apart shaped markers, and wherein the electronically segmenting comprises segmenting the image data to identify an orientation and location of the markers.

9. The method of claim 1, wherein the electronically calculating user adjustments is carried out to display turn directions and a number of turns for each thumbwheel associated with a corresponding pitch, roll, X and Y actuator of the trajectory guide.

10. A method of operating an MRI-guided surgical system, comprising:

electronically recognizing predefined physical characteristics of at least one surgical tool to automatically segment MR image data provided by an MRI scanner during an MRI-guided surgery whereby the at least one tool constitutes a point of interface with the system; and

displaying a User Interface on a display that defines workflow progression for an MRI-guided surgical procedure and allows a user to select steps in the workflow; and

generating multi-dimensional visualizations using predefined data of the at least one tool and data from MRI images of the patient in substantially real time during the surgical procedure.

11. The method of claim 10, wherein the displaying the User Interface comprises accepting input of an identifier associated with the at least one tool and blocking use of the system if the identifier of the at least one tool indicates that it is not an authorized tool or that the at least one tool has a version that is not compatible with the system.

12. The method of claim 10, wherein the at least one tool is an imaging probe with an intrabody antenna that is configured to collect small field, high-resolution image data, and wherein the method comprises electronically applying a correction to reduce intensity distortion associated with image data collected from the imaging probe.

13. The method of claim 10, wherein the at least one tool comprises a flexible patch with a grid, and wherein the electronically recognizing step comprises segmenting MRI image data to locate the patch in an MR volume, the method further comprising generating a visualization presented on the display which shows the patch as an overlay on a patient with defined grid coordinates for a surgical entry site.

14. The method of claim 10, wherein the system is a brain surgery system, wherein the at least one tool comprises a flexible brain surgery patch configured to reside on a patient'"'"'s skull, and wherein the method comprises:

electronically identifying a position and orientation of the patch on the patient based on predefined physical characteristics of the patch; and

electronically deform an electronic model of the patch to fit curvature of a patient'"'"'s skull, wherein the displaying comprises displaying a visual overlay of the patch on the skull of the patient on the at least one display.

15. The method of claim 10, wherein the system is a brain surgery system, wherein the at least one tool is a brain surgery flexible grid patch configured to reside on a patient'"'"'s head, wherein the method comprises presenting on the display, a user-selectable trajectory line to a deep brain location that intersects the grid and defines a location on the grid for marking a burr entry hole based on the desired trajectory line, and wherein the method further comprises generating an audible and/or visual warning when a user selects a trajectory line that does not intersect the grid.

16. The method of claim 10, wherein the displaying comprises displaying a location and/or coordinates of a desired location associated with a flexible grid attached to a skull of a patient that provides a desired burr hole location for a trajectory entry path through the skull of a patient.

17. The method of claim 10, wherein the at least one surgical tool comprises a trajectory guide with fiducial markers in a fixed geometric relationship, the trajectory guide configured to define a trajectory path for a subsurface brain target in the patient, the trajectory guide having a base that affixes to a patient'"'"'s skull, the base having an opening that aligns with a burr hole in the patient'"'"'s skull, and wherein the electronically recognizing step comprises segmenting MR image data to locate the fiducial markers of the trajectory guide and orient the trajectory guide in position in MRI image space.

18. The method of claim 17, wherein the trajectory guide fiducial markers includes a plurality of fiducial markers that surround the base opening spaced and are spaced apart and positioned relative to each other such that at least two are closer together than another to define an affirmative orientation of the trajectory guide, and wherein the electronically recognizing comprises segmenting MR image data to locate the fiducial markers of the base to orient the trajectory guide.

19. The method of claim 18, wherein the electronically recognizing comprises employing a statistical best-fit analysis to MRI image data to fit observed fiducial positions to expected fiducial geometry based on the fixed geometric relationship of the fiducial markers.

20. The method of claim 10, wherein the electronically recognizing comprises fitting observed signal intensity data to the fixed geometric relationship of the spaced apart fiducial markers thereby providing for a more robust image recognition while inhibiting errors if one fiducial marker has less signal intensity than others.

21. The method of claim 10, wherein the at least one surgical tool comprises a trajectory guide adapted to attach to the patient, the method further comprising calculating suggested adjustments to carry out X-Y and/or pitch and roll changes for the trajectory guide to position a probe inserted through a targeting canula held by the trajectory guide at an identified target location.

22. The method of claim 10, wherein the at least one surgical tool comprises a trajectory guide, wherein the trajectory guide comprises a frame attached to an X-Y translating platform that resides on pitch and roll control arcs, an X adjustment actuator, a Y adjustment actuator, a pitch adjustment actuator and a roll adjustment actuator, each actuator associated with the platform to provide the associated adjustment to a pivot axis of the trajectory guide, wherein the electronically recognizing step comprises identifying predefined physical characteristics of the trajectory guide and electronically determine and output to the display, which actuator to move and in which direction to align the trajectory guide to define a trajectory that reaches a target intrabody location.

23. The method of claim 10, wherein the at least one surgical tool comprises a trajectory guide, the method further comprising displaying on the display a selected projected trajectory path to a target site in the brain and at least one of an associated X adjustment, Y adjustment, pitch adjustment, and roll adjustment for actuators associated with the trajectory guide to provide the selected trajectory path.

24. The method of claim 10, further comprising receiving data regarding a bore size of the MRI Scanner, and electronically monitoring for a physical limitation or interference of a surgical tool based on:

(a) pre-defined physical characteristics of the surgical tool;

(b) MRI scanner bore size; and

(c) patient size, and wherein the method further comprises generating an audible and/or visual warning when the surgical tool will be blocked by physical interference with a wall defining at least a portion of the bore size of the MRI scanner.

25. The method of claim 10, further comprising accepting user input to select whether to (i) display patient functional data in substantially real-time in the generated visualizations and/or (ii) to display a patient'"'"'s fiber tracks in the generated visualizations.

26. The method of claim 10, wherein the User Interface selectable workflow groups include “

start”

, “

plan entry”

, “

plan target”

, “

navigate”

, and “

refine”

workflow groups that can be used to guide the surgical procedure resulting in delivering a therapy after the “

refine”

workflow group.

27. The method of claim 26, wherein the User Interface also includes an “

Administrative”

workflow group that electronically generates a medical report automatically summarizing clinical information regarding the patient and certain surgical information including at least a plurality of the following;

(a) AC, PC, and MSP points in MR space (both detected and user-specified, if user modified);

(b) planned and corrected targets in both MR and ACPC space;

(c) elapsed time for the procedure; and

(d) screenshots taken during the procedure.

28. The method of claim 10, wherein the displaying the User Interface displays different user selectable intrabody procedures including a unilateral or bilateral procedure and a desired intrabody target, wherein if a bilateral procedure is selected, the User Interface provides a toolbar with left and right workflow steps.

29. A system according to claim 10, wherein the displaying the User Interface for bilateral procedures comprises displaying workflow steps that guides a user to complete grid entry locations for both sides, burr hole formation for both sides and trajectory frame attachment to both sides before proceeding to a “

plan target”

step due to brain shift and before directing a patient to be returned to an imaging location in the magnet.