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

• US 20090171184A1
• Filed: 09/24/2008
• Published: 07/02/2009
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc., Mdesign & Product Development, Inc.
• Original Assignee: SurgiVision Inc.
• Inventors: Farberov, Pavel, Hotte, Philip Bradley, Orr, Timothy Neil, Sayler, David John, Geiger, Paul Arthur, Piferi, Peter, Jenkins, Kimble
• Granted Patent: US 8,315,689 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. An MRI-guided surgical system, comprising:

at least one MRI-compatible surgical tool;

a circuit adapted to communicate with an MRI scanner, wherein 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; and

at least one display in communication with the circuit,

wherein 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 predefined data of the at least one tool and data from MRI images of the patient in substantially real time during the surgical procedure.

2. An MRI-guided surgical system according to claim 1, wherein the User Interface is configured to accept input of an identifier associated with the at least one tool and to block 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.

3. An MRI-guided surgical system according to claim 1, 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 circuit is configured to electronically apply a correction to reduce intensity distortion associated with image data collected from the imaging probe.

4. A surgical system according to claim 1, wherein the at least one tool comprises a flexible patch with a grid, and wherein the circuit is configured with a segmentation module that is able to locate the patch in an MR volume, and generate 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.

5. A surgical system according to claim 1, wherein the system is a brain surgery system, wherein the flexible patch is a brain surgery patch configured to reside on a patient'"'"'s skull, and wherein the circuit is configured to identify the patch position and orientation on the patient based on predefined physical characteristics of the patch, electronically deform the patch to fit curvature of a patient'"'"'s skull, and generate and display a visual overlay of the patch on the skull of the patient.

6. A surgical system according to claim 1, 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 circuit is configured to visually illustrate 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 User Interface displays an audible and/or visual warning when the user selects trajectory line that does not intersect the grid.

7. A surgical system according to claim 6, wherein the circuit is configured to display a location and/or coordinates associated with the grid that provides a desired burr hole location for a trajectory entry path through a skull of a patient.

8. A system according to claim 1, 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 a substantially circular opening that aligns with a burr hole in the patient'"'"'s skull and encloses a space for two pivot axes of rotation of the trajectory guide, and wherein the circuit is configured to segment MR image data to locate the fiducial markers of the trajectory guide and orient the trajectory guide.

9. A system according to claim 8, wherein the trajectory guide fiducial markers includes a plurality of fiducial markers that surround the base opening, and wherein the circuit is configured to segment MR image data to locate the fiducial markers of the base and orient the trajectory guide.

10. A system according to claim 9, wherein the fiducial markers are circumferentially 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.

11. A system according to claim 8, wherein the fiducial markers comprise three fluid-filled annular fiducial markers.

12. A system according to claim 8, wherein the circuit is configured to employ 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.

13. A system according to claim 10, wherein the circuit is configured to fit observed signal intensity data to a known geometric circumferential relationship of the circumferentially 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.

14. A system according to claim 8, wherein the circuit comprises a segmentation module for a base of a trajectory frame, a segmentation module for one or more markers associated with a targeting canula held by the trajectory guide, and wherein the circuit is configured, before a probe is inserted fully, to calculate an extrapolated projection along the probe'"'"'s axis and display an error in position if a current insertion path is followed.

15. A system according to claim 8, wherein the circuit is configured to calculate and provide suggested adjustments to carry out X-Y and/or pitch and roll changes for the trajectory guide to position a probe inserted through the targeting canula held by the trajectory guide in the brain at an identified target location

16. A system according to claim 8, 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 circuit comprises a module that has predefined physical characteristics of the trajectory guide and is configured to electronically determined and output to a user via the display, which actuator to move and in which direction to align the trajectory to reach the target location.

17. A system according to claim 8, wherein the circuit is configured to generate a visual of a selected projected trajectory path to a target site in the brain and display 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.

18. A system according to claim 1, wherein the circuit has or is configured to receive data regarding a bore size of the MRI Scanner, and wherein the circuit is configured to monitor 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 circuit is configured to generate 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.

19. A system according to claim 1, further comprising a clinician workstation with the display in communication with the circuit, wherein the at least one tool comprises a trajectory guide with a frame that attaches to a patient, wherein the circuit is configured to segment MRI image data of the patient and define a roll axis and a pitch axis based on interrogation of the MRI data in substantially real-time to locate at least one frame marker and register the trajectory guide in position on the patient, and wherein the circuit is configured to calculate an insertion depth of a probe associated with the at least one tool to reach a selected intrabody target using the predefined physical characteristics of the trajectory guide.

20. A system according to claim 1, wherein the circuit is configured to generate color coded electroanatomical visualizations of target anatomy in substantially real-time, using at least one of:

(a) electrical signals obtained from electrodes associated with the at least one tool, correlated to time and position of the electrodes to render visualizations to illustrate neural electrical potentials and locations;

or

(b) patient functional data including fMRI data and/or MRI image data showing electrical activity in response to a stimulation.

21. A system according to claim 1, in combination with an MRI scanner, and further comprising a clinician workstation in communication with the MRI scanner and the circuit, wherein the circuit comprises a DICOM interface that receives MRI images from the MRI scanner, and wherein the MRI scanner comprises a module that allows communication with the clinician workstation.

22. A system according to claim 21, wherein the circuit and clinician workstation passively receives data from the MRI scanner.

23. A system according to claim 1, in combination with an MRI scanner, and further comprising a clinician workstation in communication with the MRI scanner and the circuit, and wherein the circuit receives pre-DICOM reconstructed MR image data and/or receives MR data and generates the image construction for the visualization.

24. A system according to claim 1, wherein the circuit is configured to display substantially real-time patient functional information in the visualizations.

25. A system according to claim 1, wherein the User Interface is configured with an input that allows a user to select whether to display patient functional data in substantially real-time in the visualizations and/or to display a patient'"'"'s fiber tracks in the visualizations.

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

defining dimensional and/or functional data of at least one MRI compatible surgical tool;

obtaining MRI image data of the patient;

electronically segmenting the MRI image data to identify known fiducial markers on the at least one tool based on the defining step;

generating visualizations of the at least one tool registered to patient anatomical structure;

electronically generating directions on adjustments for a pitch, roll or X-Y actuator to adjust a trajectory of a trajectory guide; and

guiding the tool to a location in the patient using MRI image data, the directions for adjustment and the visualizations thereby facilitating an MRI-guided surgical procedure.

27. A method according to claim 26, wherein the generating visualizations includes displaying patient function.

28. A method according to claim 27, wherein the patient function is shown as active regions of a brain in response to a defined stimulation and/or fMRI in substantially real-time and/or displaying fiber tracks of the patient in the visualizations.

29. A computer program product for facilitating an MRI-guided surgical procedure, the computer program product comprising:

a computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code that comprises predefined physical data of a plurality of different surgical tools;

computer readable program code that communicates with an MRI scanner to obtain MRI image data of a patient; and

computer readable program code that generates visualizations of the patient using data from the tools and the image data of the patient in substantially real-time.

30. A computer program product according to claim 29, further comprising computer readable program code that obtains image data of patient function, and wherein the computer readable program code that generates the visualizations also shows patient function including active regions in a brain based on fMRI and/or patient stimulation.

31. A MRI-guided interventional deep brain system, comprising:

an MRI Scanner;

a clinician workstation with a circuit and a display, the workstation in communication with the MRI Scanner;

a flexible patch with a grid thereon configured to releasably attach to a patient'"'"'s skull; and

a trajectory guide attachable to a skull of a patient, the guide having a base with an aperture configured to reside over a burr hole formed in a patient'"'"'s skull, the base aperture providing a mechanical center of rotation for a pivot axis associated with the trajectory guide, the trajectory guide having a plurality of spaced apart fiducial markers;

wherein the circuit comprises physical data regarding the patch and is configured to interrogate patient imaging data provided by the MRI Scanner and segment the image data to define a burr hole location that intersects the patch with a desired intrabrain trajectory, and wherein the circuit comprises tool-specific data of the trajectory guide and is configured to interrogate patient imaging data provided by the MRI Scanner and interactively generate visualizations of the patient'"'"'s brain and the trajectory guide to the display.

32. A system according to claim 31, wherein the circuit is configured to obtain patient function data and generate the visualizations showing patient function in substantially real time.

33. A system according to claim 31, wherein the circuit is configured to provide a default trajectory for the trajectory guide on the display that extends through a center location of the grid patch.

34. A system according to claim 31, further comprising at least one fiber optic device attached to the trajectory guide for viewing the burr hole with a local field of view, the fiber optic device being in communication with an MRI compatible camera.

35. A system according to claim 31, wherein the system comprises two grid patches and two trajectory guides for a bilateral procedure, and two fiber optic video stream imaging devices, one mounted to each trajectory guide, each being in communication with a different MRI compatible camera mounted proximate a bore of the MRI Scanner, and wherein the workstation displays a video stream from one or both of the cameras while also displaying the visualizations.

36. A system according to claim 31, wherein the system is configured to determine and display a depth value for a user to set on a depth stop associated with an intrabody probe or lead prior to insertion.

37. A system according to claim 31, wherein the circuit is in communication with a User Interface for a display whereby a user can:

(a) select an intrabrain target, (b) select or specify a position in MR coordinates representing a lead tip, and (c) select or specify an identifier that selects a set of offsets indicating electrode offsets from the lead tip, and wherein the circuit is configured, for each offset value, to provide an AC-PC coordinate that corresponds to a point offset from the tip position back along the trajectory of the lead whereby the AC-PC coordinates correspond to the electrode positions in AC-PC space.

38. A system according to claim 31, wherein the circuit is in communication with a User Interface that includes a series of selectable workflow groups including “

start”

, “

plan entry”

, “

plan target”

, “

navigate”

, and “

refine”

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

refine”

workflow group.

39. A system according to claim 38, wherein the User Interface allows a user to select whether to show patient function information in the visualizations.

40. A system according to claim 38, wherein the User Interface also includes an “

Administrative”

workflow group whereby the circuit 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;

(d) physician case notes (optional); and

(e) screenshots taken during the procedure.

41. A system according to claim 31, wherein the circuit is configured to generate a warning when a user selects or draws a trajectory that does not intersect the grid patch.

42. A system according to claim 31, wherein the circuit is configured to require hardware identifier data, and wherein if the identifier data is not recognized or is defined to be incompatible with the circuit, the system is configured to inhibit use of the system.

43. A system according to claim 31, further comprising an imaging probe with an intrabody antenna that is configured to extend through the targeting canula and collect small field, high-resolution image data, and wherein the circuit is configured to electronically apply a correction to reduce intensity distortion associated with image data collected from the imaging probe.

44. A system according to claim 31, further comprising a User Interface that allows a user to select different 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.

45. A system according to claim 44, wherein the User Interface for bilateral procedures comprises workflow steps in a visual control 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.

46. A system according to claim 31, wherein the system comprises a User Interface with workflow steps, and wherein the User Interface comprises a control that allows a user to select to show patient function information in the visualizations in substantially real-time during at least one of a “

plan entry”

, “

plan target”

, “

navigate”

, “

refine”

or “

deliver therapy”

step.

47. A system according to claim 31, wherein the trajectory guide comprises a targeting canula with a central passage and at least one fiducial marker, and wherein the circuit is configured to request and/or obtain high resolution image data from the MR scanner of a slab that includes the at least one fiducial marker based on predefined physical characteristics of the targeting canula to determine an actual trajectory of the targeting canula.

48. A system according to claim 47, wherein the at least one marker comprises a proximal marker and a distal marker, and wherein the circuit is configured to selectively request a slab of a single one of the proximal or distal markers at a single point in time.

49. A system according to claim 31, wherein the trajectory guide comprises a targeting canula with a central passage and spaced apart proximal and distal fiducial markers, the proximal marker having a different shape than the distal marker, and wherein the circuit is configured to request and/or obtain high resolution image data from the MR scanner of a slab that includes only one of the proximal or distal markers based on predefined physical characteristics of the targeting canula.