MRI-GUIDED LOCALIZATION AND/OR LEAD PLACEMENT SYSTEMS, RELATED METHODS, DEVICES AND COMPUTER PROGRAM PRODUCTS

• US 20090118610A1
• Filed: 11/29/2006
• Published: 05/07/2009
• Est. Priority Date: 11/29/2005
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Karmarkar, Parag V., Jenkins, Kimble
• Granted Patent: US 9,042,958 B2
• Time in Patent Office: Days
• US Class Current: 600/420
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 5/6865 Access ports
• 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: A61M 39/08 Tubes; Storage means specially adapted therefor
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/08 : Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/086 : Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/3718 : Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G01R 33/285 : Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
• 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 33/287 : involving active visualization of interventional instruments, e.g. using active tracking RF coils or coils for intentionally creating magnetic field inhomogeneities
• CPC Class Codes: G01R 33/288 : Provisions within MR facilities for enhancing safety during MR, e.g. reduction of the specific absorption rate [SAR], detection of ferromagnetic objects in the scanner room
• CPC Class Codes: G01R 33/34084 : implantable coils or coils being geometrically adaptable to the sample, e.g. flexible coils or coils comprising mutually movable parts
• CPC Class Codes: G01R 33/4808 : Multimodal MR, e.g. MR combined with positron emission tomography [PET], MR combined with ultrasound or MR combined with computed tomography [CT]

Abstract

MRI compatible localization and/or guidance systems for facilitating placement of an interventional therapy and/or device in vivo include: (a) a mount adapted for fixation to a patient; (b) a targeting cannula with a lumen configured to attach to the mount so as to be able to controllably translate in at least three dimensions; and (c) an elongate probe configured to snugly slidably advance and retract in the targeting cannula lumen, the elongate probe comprising at least one of a stimulation or recording electrode. In operation, the targeting cannula can be aligned with a first trajectory and positionally adjusted to provide a desired internal access path to a target location with a corresponding trajectory for the elongate probe. Automated systems for determining an MR scan plane associated with a trajectory and for determining mount adjustments are also described.

Claims

1. An MRI compatible localization and/or guidance system for facilitating placement of an interventional device in vivo, comprising:

a mount having a base with a patient access aperture adapted for fixation to a patient, wherein an upper portion of the mount is able to controllably translate with at least two degrees of freedom;

a targeting cannula having at least one axially extending lumen configured to attach to the mount; and

an elongate probe configured to snugly slidably advance and retract in one of the at least one axially extending lumen of the targeting cannula, the elongate probe comprising at least one of a recording electrode or a stimulation electrode,

wherein, in operation, the mount can be adjusted to provide a desired internal access path trajectory to a target location.

2. An MRI compatible system according to claim 1, wherein the elongate probe is an MRI visible probe.

3. An MRI compatible system according to claim 1, wherein the targeting cannula comprises a first open lumen and a second closed axially extending fluid filled channel or lumen.

4. An MRI compatible system according to claim 1, wherein the targeting cannula comprises a plurality of axially spaced apart microcoils configured to transmit signal data used to define a trajectory of the targeting cannula in vivo.

5. An MRI compatible system according to claim 1, wherein the at least one electrode comprises an electro-acoustic transducer that is configured to detect a local EEG signal (recording electrode).

6. An MRI compatible system according to claim 1, wherein the elongate probe at least one electrode comprises at least one stimulation electrode.

7. An MRI compatible system according to claim 1, wherein the elongate probe further comprises an imaging antenna configured to receive MRI signal from local tissue.

8. An MRI compatible system according to claim 1, wherein the targeting cannula comprises an MRI imaging antenna configured to receive MRI signal from contrast fluid in a fluid filled elongate segment of an elongate member.

9. An MRI compatible system according to claim 3, further comprising a delivery sheath sized and configured to slidably receive the elongate probe, and wherein the elongate probe and/or delivery sheath define an MRI imaging antenna configured to receive MRI signal from the fluid in the fluid channel or lumen of the targeting cannula.

10. An MRI compatible system according to claim 9, wherein the delivery sheath comprises MRI coils

11. An MRI compatible system according to claim 1, further comprising a multi-lumen insert configured to mount to the frameless mount and hold the targeting cannula in one of the lumens thereof.

12. An MRI compatible system according to claim 3, wherein the axially extending fluid filled channel or lumen is substantially concentrically positioned about the first lumen.

13. An MRI compatible system according to claim 3, wherein the fluid filled channel or lumen comprises opposing end portions having a substantially spherical shape.

14. An MRI compatible system according to claim 1, wherein the elongate probe is a multi-purpose probe having at least one stimulation electrode and at least one recording electrode.

15. An MRI compatible system according to claim 1, further comprising a chronically implantable MRI compatible neuromodulation lead configured to slidably advance in a slidably retractably sheath along an access path defined by the targeting cannula and/or probe associated with a target implant location.

16. An MRI compatible system according to claim 1, wherein the probe comprises a slidably extendable sheath residing on an outer wall thereof, the system further comprising an implantable deep brain stimulation (DBS) lead comprising a plurality of stimulation electrodes, the DBS lead configured to slidably advance in the retractable sheath along an access path defined by the targeting cannula and/or probe associated to a target implant location for the electrodes in neural tissue.

17. An MRI compatible system according to claim 1, further comprising an electronic in vivo access path trajectory determination circuit in communication with the mount, the module comprising a computer readable storage medium having computer readable program code embodied in the medium, the computer-readable program code comprising:

computer readable program code configured to electronically determine at least one of the following;

(a) coordinates of a position in 3-D MR space of the elongate probe;

or (b) coordinates of a position in 3-D MR space of the targeting cannula.

18. A system according to claim 1, wherein the mount is a frameless mount configured to mount to a skull of a patient about a burr hole formed therein, and wherein the system is sized and configured to guide deep brain placement of a stimulation lead in vivo and to collect and provide feedback of positional data of the elongate probe in substantially real time.

19. A system according to claim 1, wherein the elongate probe at least one electrode includes a recording electrode that is configured to detect signals associated with the patient'"'"'s local neural structure.

20. A system according to claim 1, further comprising a control circuit in communication with an MRI scanner to automatically detect a scan plane associated with the targeting cannula and/or probe based on MRI image data of the patient.

21. A system according to claim 1, wherein the system comprises a stimulation circuit that is configured to block RF signals at a resonant frequency associated with a magnetic field strength of a MRI system used to operate an MRI antenna defined at least partially by the elongate probe.

22. A system according to claim 1, wherein the targeting cannula comprises a plurality of axially extending lumens.

23. A system according to claim 21, wherein an elongate member with fluid in an axially extending closed channel is sized and configured to extend in one of the lumens.

24. An MRI compatible localization and/or guidance system for facilitating placement of an interventional device in vivo, comprising:

a mount having a receiving port and a base with an access aperture adapted for fixation to a patient, the mount port configured to translate with at least two degrees of freedom;

a targeting cannula having at least one axially extending lumen configured to reside in the port; and

an elongate probe configured to define an MRI antenna configured to snugly and slidably advance and retract in one of the at least one axially extending lumen of the targeting cannula,

wherein, in operation, the targeting cannula can be positionally adjusted in the mount to provide a desired internal access path trajectory through the mount access aperture to a target location.

25. An MRI interventional tool, comprising:

a cannula with an open through lumen and at least one axially extending closed fluid filled lumen or channel; and

a first multipurpose probe configured to slidably extend through the open lumen of the cannula.

26. An MRI tool according to claim 25, wherein the first multipurpose probe is configured to define an MRI antenna and includes at least one stimulation electrode.

27. An MRI tool according to claim 25, further comprising a second probe comprising captured fluid sized and configured to be slidably received in the through lumen.

28. An MRI-compatible interventional tool, comprising:

a frameless mount;

a multi-lumen insert configured to mount to the frameless mount; and

an MRI visible targeting cannula with a closed perimeter configured to slidably reside in one lumen of the multilumen insert when the insert is mounted to the frameless mount.

29. A tool according to claim 28, wherein the insert and mount define a unitary integral device.

30. A tool according to claim 28, wherein the targeting cannula comprises at least one axially extending fluid filled lumen or channel.

31. A tool according to claim 28, wherein the targeting cannula comprises at least one side arm with contrast medium therein configured to reside in one of the other lumens of the multi-lumen insert.

32. An MRI interventional or placement tool, comprising:

a mount having a patient access aperture configured to mount to a patient;

an elongate delivery sheath extendable from the access aperture of the mount to a target access location in the patient; and

a fluid filled tube configured to slidably advance with and retract from the sheath.

33. A tool according to claim 32, further comprising a lead with a stimulation electrode configured to sildably advance in the sheath after the fluid filled tube is removed.

34. A tool according to claim 32, wherein the sheath comprises at least one MRI imaging coil.

35. An MRI compatible localization and/or guidance system for facilitating placement of an interventional therapy or device in vivo, comprising:

a mount having a base with a patient access aperture adapted for fixation to a patient, wherein an upper portion of the mount is able to controllably translate;

a targeting cannula having at least one axially extending lumen configured to attach to the mount;

a fluid-filled elongate member configured to reside in the axially extending lumen of the targeting cannula; and

an elongate probe configured to snugly slidably advance and retract in one of the axially extending lumen of the targeting cannula, the elongate probe comprising an MRI imaging coil at a distal portion thereof and at least one of a recording electrode or a stimulation electrode downstream of the imaging coil,

wherein, in operation, the mount can be adjusted to provide a desired internal access path trajectory to a target location.

36. An MRI guided localization system comprising:

a base with an in vivo access aperture configured to mount to a patient;

a translatable mount member attached to the base, the translatable member configured to translate about a pivot point extending proximate the base access aperture, the translatable member having a receiving port configured to receive at least one of a targeting cannula or a multi-lumen insert;

a plurality of sensors in communication with at least one of the base and translatable member whereby the sensors define positional data of the mount member;

a drive system in communication with the translatable mount member; and

a control circuit in communication with the drive system configured to direct the translatable member to translate to define a desired trajectory orientation.

37. A system according to claim 36, wherein the translatable mount member comprises calibrated manual adjustment movements for precise movement of the mount member to a desired rotation and translation configuration.

38. A system according to claim 36, wherein the translatable mount member comprises a pair of spaced apart upwardly extending arms that define a curvilinear travel path for the receiving port, and wherein the arms mount to a rotatable platform attached to the base.

39. An automated trajectory adjustment system, comprising:

a mount member with a base having an access aperture extending therethrough configured to reside against a mounting surface of a patient;

an MRI visible elongate member configured to mount to the mount member;

at least one position sensor in communication with the mount member;

a drive system in communication with the mount member; and

a control circuit in communication with the drive system configured to identify adjustments to alter the position of the mount member to obtain a desired trajectory of an access path through the access aperture into the patient.

40. A system for MRI guided localization of therapies/tools, comprising:

an MRI visible elongate member; and

a localization system in communication with a MRI scanner configured to programmatically determine a scan plane location of the elongate member having a first trajectory in 3D MRI space whereby the elongate member acts as an MRI detectable marker.

41. A system according to claim 40, wherein the localization system is configured to electronically determine positional adjustments of a mount attached to a patient holding the elongate member to define a second adjusted trajectory to a target site.

42. A system according to claim 40, wherein the localization system is configured to electronically identify at least one of pixels or voxels with increased signal intensity to determine the scan plane associated with the elongate member.

43. A system according to claim 40, wherein the elongate member comprises a fluid filled channel with an axially extending through lumen.

44. A system according to claim 40, wherein the elongate member comprises a fluid filled lumen with axially spaced apart spherical segments.

45. A method for automatically defining a scan plane associated with an elongate MRI visible marker, comprising:

programmatically determining a scan plane location of an MRI visible elongate member held in a mount affixed to a patient and residing in 3D MRI space with an associated first trajectory.

46. A method according to claim 45, wherein the elongate member is one of a targeting cannula or stimulation probe, the method further comprising electronically determining positional adjustments of the mount holding the targeting cannula and/or probe to define a second adjusted trajectory with respect to a target site.

47. A method according to claim 45, further comprising electronically generating predicted trajectory lines that intersect a target subsurface location associated with different lumens of a multi-lumen insert held in the mount.

48. A method according to claim 46, further comprising generating projection images in a plurality of orthogonal planes to define a registered position of the mount and a remote center of motion (RCM) point proximate an access path into the patient.

49. A method according to claim 45, wherein the programmatically determining a scan plane comprises identifying an object having increased SNR in 3D MRI space of image data of the patient.

50. A method according to claim 45, wherein the programmatically determining a scan plane comprises:

obtaining sagittal and coronal projection images of head of the patient;

applying high intensity filtering to identify the pixels or voxels in data associated with the obtained images to identify the location of the elongate member; and

determining coordinates of the elongate member in space based on the filtering.

51. A method according to claim 50, wherein the determining comprises using image recognition and/or linear regression.

52. A method according to claim 45, wherein the programmatically determining a scan plane comprises:

obtaining a 3D volumetric scan of a head of the patient;

analyzing scan data using high intensity filtering to identify the location of the elongate member;

then

determining coordinates of the elongate member in space.

53. A method according to claim 52, wherein the determining comprises using 3D image recognition and/or linear regression.

54. A method according to claim 50, wherein positional adjustments for the mount to obtain desired adjusted trajectory are determined in less than about 10 minutes after the image data is obtained.

55. A method according to claim 45, further comprising electronically calculating an RCM point and electronically determining points associated with trajectory of the elongate member in MRI space to electronically define an altered desired trajectory in less than about 10 minutes.

56. A method according to claim 46, further comprising generating a visualization of alternate trajectories through the mount to a desired intersection location in the body on a display.

57. A frameless head mount for MRI interventional procedures, comprising:

a base having a patient access aperture configured to affix to a burr hole in a skull of a patient;

a rotatable platform attached to the base; and

a pair of spaced apart upwardly extending arms holding a receiving port attached to the platform, the receiving port being able to translate and rotate while held by the arms to define different axial trajectories extending through the patient access aperture.

58. A frameless head mount according to claim 57, further comprising a user rotation adjustment member attached to the platform and a user pitch adjustment member attached to at least one of the arms whereby the adjustment members allow a user to move the mount.

59. A frameless head mount according to claim 57, further comprising respective non-ferromagnetic flexible drive cables attached to the rotation and pitch adjustment members to allow a user to adjust an access path trajectory while the user resides proximate but outside an end of a bore of a magnet associated with an MRI scanner without moving the patient.

60. A frameless head mount according to claim 57, further comprising an automated trajectory adjustment circuit in communication with the adjustment members whereby the receiving port is automatically moved to a desired position based on MRI data.

61. A method of adjusting a trajectory of a head mount defining an internal access path trajectory during an MRI-guided interventional procedure, comprising:

affixing a head mount with a holding member having adjustable pitch and rotation to a head of a patient; and

adjusting at least one of pitch or rotation of the holding member to define a desired access path trajectory into the patient while the patient remains in position in a bore of a magnet.