MRI-guided medical interventional systems and methods

• US 8,175,677 B2
• Filed: 06/06/2008
• Issued: 05/08/2012
• Est. Priority Date: 06/07/2007
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Sayler, David John, Mazzei, Raffaele, Jenkins, Kimble L., Piferi, Peter
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Luong, Peter
• Application Number:
  US12/134,412
• Publication Number:
  US 20080306375A1
• Time in Patent Office: 1,432 Days
• Field of Search: 600/417, 600/424, 600/427, 600/429
• US Class Current: 600/417
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• 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 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• 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 34/71 : Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 34/74 : Manipulators with manual electric input means
• CPC Class Codes: A61B 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/4064 : Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• 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: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G01R 33/283 : Intercom or optical viewing arrangements, structurally associated with NMR apparatus
• 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 33/34046 : Volume type coils, e.g. bird-cage coils; Quadrature bird-cage coils; Circularly polarised coils
• CPC Class Codes: G01R 33/3415 : comprising arrays of sub-coils , i.e. phased-array coils with flexible receiver channels

Abstract

An MRI-guided interventional system includes a frame with a cooperating targeting cannula. The frame is configured to be secured to the body of a patient, and is configured to translate and rotate such that the targeting cannula can be positioned to a desired intrabody trajectory. The frame may include one or more MRI-visible fiducial markers that allow frame location/orientation to be determined within an MRI image. A plurality of user-activatable actuators are configured to translate and rotate the frame relative to the body of a patient so as to position the targeting cannula to a desired intrabody trajectory. The targeting cannula includes an axially-extending guide bore therethrough that is configured to guide placement of an interventional device in vivo. Various instrumentation and equipment, such as stimulation leads, ablation catheters, injection catheters, etc., can be inserted through the targeting cannula to execute diagnostic and/or surgical procedures.

Claims

1. An MRI-guided interventional system, comprising:

a frame that supports a cooperating targeting cannula that is movable along a Z-direction, wherein the frame is configured to translate and rotate such that the targeting cannula can be positioned to a desired intrabody trajectory, and wherein the targeting cannula includes a guide bore therethrough that is configured to guide placement of an interventional device in vivo, wherein the frame comprises;

a base having a patient access aperture formed therein, wherein the base is configured to be secured to the body of a patient;

a yoke movably mounted to the base and rotatable about a roll axis; and

a platform movably mounted to the yoke and rotatable about a pitch axis,

wherein an X-Y support table is movably mounted to the platform and is configured to translate in both an X-direction and Y-direction relative to the Z-direction; and

a plurality of user-activatable actuators operably connected to the frame that are configured to translate and rotate the frame relative to the body of the patient so as to position the targeting cannula to a desired intrabody trajectory.

2. The system of claim 1, wherein the frame comprises:

a roll actuator operably connected to the yoke and configured to rotate the yoke about the roll axis;

a pitch actuator operably connected to the platform and configured to rotate the platform about the pitch axis;

an X-direction actuator operably connected to the platform and configured to move the X-Y support table in the X-direction; and

a Y-direction actuator operably connected to the platform and configured to move the X-Y support table in the Y-direction.

3. The system of claim 2, wherein the roll actuator, pitch actuator, X-direction actuator, and Y-direction actuator each have respective free ends which extend outwardly from the frame along a common direction.

4. The system of claim 1, wherein the base comprises a plurality of locations for attaching the base to a body of a patient via fasteners.

5. The system of claim 4, wherein each location comprises a plurality of adjacent apertures configured to receive a fastener therethrough.

6. The system of claim 1, wherein the base is configured to be secured to the skull of a patient about a burr hole formed therein, and wherein the targeting cannula guide bore is configured to guide intra-brain placement of a device in vivo.

7. The system of claim 6, wherein the base comprises a plurality of locations for attaching the base to a skull of a patient via fasteners.

8. The system of claim 1, wherein the yoke comprises a pair of spaced apart arcuate arms, and wherein the platform engages and moves along the arcuate arms when rotated about the pitch axis.

9. The system of claim 8, wherein at least one of the yoke arcuate arms comprises a thread pattern formed in a surface thereof, and wherein the pitch actuator comprises a rotatable worm with teeth configured to engage the thread pattern, and wherein rotation of the worm causes the platform to rotate about the pitch axis.

10. The system of claim 1, wherein the base comprises a pair of spaced apart arcuate arms, and wherein the yoke engages and moves along the arcuate arms when rotated about the roll axis.

11. The system of claim 10, wherein at least one of the base arcuate arms comprises a thread pattern formed in a surface thereof, and wherein the roll actuator comprises a rotatable worm with teeth configured to engage the thread pattern, and wherein rotation of the worm causes the yoke to rotate about the roll axis.

12. The system of claim 1, further comprising:

a remote control unit comprising a plurality of controls; and

a plurality of control cables, each cable operably connected to a respective control and to a respective actuator, wherein movement of a control operates a respective actuator via a respective control cable.

13. The system of claim 12, wherein the control unit comprises a roll adjustment control, a pitch adjustment control, an X-direction adjustment control, and a Y-direction adjustment control;

wherein a roll control cable is operably connected to the roll adjustment control and to the roll actuator, wherein movement of the roll adjustment control operates the roll actuator via the roll control cable;

wherein a pitch control cable is operably connected to the pitch adjustment control and to the pitch actuator, wherein movement of the pitch adjustment control operates the pitch actuator via the pitch control cable;

wherein an X-direction control cable is operably connected to the X-direction control and to the X-direction actuator, wherein movement of the X-direction adjustment control operates the X-direction actuator via the X-direction control cable; and

wherein a Y-direction control cable is operably connected to the Y-direction control and to the Y-direction actuator, wherein movement of the Y-direction adjustment control operates the Y-direction actuator via the Y-direction control cable.

14. The system of claim 13, wherein the roll adjustment control, pitch adjustment control, X-direction adjustment control, and Y-direction adjustment control are manually-operated thumbwheels, and wherein rotation of each thumbwheel by a user causes corresponding axial rotation of a respective control cable and corresponding axial rotation of a respective actuator.

15. The system of claim 14, further comprising a locking mechanism associated with each thumbwheel, wherein each locking mechanism is configured to prevent rotation of a respective thumbwheel.

16. The system of claim 13, wherein the roll adjustment control, pitch adjustment control, X-direction adjustment control, and Y-direction adjustment control are electric motor-assisted, rotatable controls, and wherein rotation of each control causes corresponding axial rotation of a respective control cable and corresponding axial rotation of a respective actuator.

17. The system of claim 12, further comprising a locking mechanism associated with each control, wherein each locking mechanism is configured to prevent operation of a respective control.

18. The system of claim 12, wherein each control cable has a geometrically shaped rigid end configured to removably engage a free end of a respective actuator.

19. The system of claim 12, wherein each control cable has a rigid end with a shape that is different from the other control cable rigid ends such that each control cable free end can only removably engage one of the respective actuator free ends.

20. The system of claim 12, wherein each control cable has a flexible elastomeric collar configured to surround a respective actuator free end and to maintain engagement of the cable end to a respective actuator free end.

21. The system of claim 12, wherein the control cables are MRI compatible cables.

22. The system of claim 12, wherein the actuators are color-coded such that each actuator has a respective different color.

23. The system of claim 12, further comprising a drape configured to be positioned near the body of a patient and comprising a pocket configured to removably receive the remote control unit therein.

24. The system of claim 23, wherein the drape comprises an aperture through which the cables extend from the remote control unit to the frame.

25. The system of claim 12, further comprising a safety lanyard that secures the remote control unit to a rigid object to prevent inadvertent detachment of the control cables.

26. The system of claim 1, further comprising a video imaging probe removably secured to the frame.

27. The system of claim 26, wherein the video imaging probe is removably secured to the frame via a bracket, and wherein the bracket comprises a sleeve configured to slidably receive the imaging device therein.

28. The system of claim 1, further comprising an elongated tubular member extending through the platform and yoke and secured to the X-Y table, wherein the targeting cannula is slidably secured within the tubular member and is movable between extended and retracted positions, and wherein the targeting cannula is configured to translate in response to translational movement of the X-Y support table and to rotate in response to rotational movement of the yoke and platform to define different axial trajectories extending through the patient access aperture.

29. The system of claim 28 wherein the tubular member is configured to lock the targeting cannula in an extended position and in a retracted position.

30. The system of claim 28, further comprising a depth stop configured to receive a sheath therein, wherein the sheath is configured to receive an elongated interventional device therethrough, wherein the depth stop is removably secured within a proximal end of the tubular member, and wherein the depth stop limits a distance that the sheath can extend into the body of a patient when the depth stop is secured within the proximal end of the tubular member.

31. The system of claim 30, wherein the sheath is configured to be removable when the depth stop is secured within the proximal end of the tubular member.

32. The system of claim 30, further comprising a locking mechanism removably secured to the depth stop, wherein the locking mechanism is configured to prevent axial movement of an elongated interventional device extending through the sheath.

33. The system of claim 1, further comprising a plurality of MRI-visible fiducial markers attached to the frame.

34. The system of claim 1, further comprising a removable centering device that matingly engages the patient access aperture in the base to center the patient access aperture relative to an opening in the body.

35. The system of claim 1, wherein the guide bore defines a trajectory axis, and the plurality of actuators each extend from the frame in a direction substantially parallel to the trajectory axis.

36. An MRI-guided interventional system, comprising:

a frame that supports a cooperating targeting cannula that is movable along a Z-direction, wherein the frame is configured to move such that the targeting cannula can be positioned to a desired intrabody trajectory, and wherein the targeting cannula includes a guide bore therethrough that is configured to guide placement of an interventional device in vivo, wherein the frame comprises;

a base having a patient access aperture formed therein, wherein the base is configured to be secured to the body of a patient;

a yoke movably mounted to the base and rotatable about a roll axis; and

a platform movably mounted to the yoke and rotatable about a pitch axis, wherein an X-Y support table is mounted to the platform and is configured to translate in both an X-direction and a Y-direction relative to the Z-direction;

a plurality of user-activatable actuators operably connected to the frame that are configured to rotate the frame relative to the body of the patient so as to position the targeting cannula to a desired intrabody trajectory; and

wherein the system further comprises at least one of the following;

color-coded actuators wherein each actuator has a respective different color;

or

a remote control unit comprising a plurality of elongate control devices, wherein each control device comprises first and second elongate rods axially connected at respective first ends via a first cable, wherein the first rod second end is operably connected to a respective actuator via a second cable, and wherein rotational movement of the second end of the second rod operates the actuator via the second cable.

37. The system of claim 36, wherein the frame comprises:

a roll actuator operably connected to the yoke and configured to rotate the yoke about the roll axis; and

a pitch actuator operably connected to the platform and configured to rotate the platform about the pitch axis.

38. The system of claim 37, wherein each second cable has a geometrically shaped rigid end configured to removably engage a free end of a respective actuator.

39. A method of adjusting a trajectory of an in vivo interventional device, comprising:

affixing a frame to the body of a patient, wherein the frame comprises an X-Y support table configured to translate in both an X-direction and a Y-direction relative to a Z-direction, wherein the X-Y support table supports a targeting cannula that is movable along the Z direction, wherein the X-Y support table is configured to rotate about at least two different axes such that the targeting cannula can be positioned to a desired access path trajectory, and wherein the targeting cannula includes a guide bore therethrough that is configured to guide placement of an interventional device in vivo; and

adjusting at least one of translation or rotation of the frame to define a desired access path trajectory into the patient while the patient remains in position in a magnetic field associated with an MRI scanner.

40. The method of claim 39, further comprising inserting an interventional device through the targeting cannula guide bore and into the body of the patient.

41. The method of claim 39, wherein the targeting cannula is movable between retracted and extended positions, and wherein the targeting cannula is moved to the extended position and locked in the extended position prior to the adjusting step.

42. The method of claim 39, wherein the adjusting step comprises displaying rotational and translational adjustments required to position the targeting cannula to the desired access path trajectory on a workstation display.

43. The method of claim 42, further comprising displaying the desired access path trajectory on a workstation display.

44. The method of claim 42, further comprising displaying an actual access path trajectory of the targeting cannula on a workstation display.