MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time

• US 8,369,930 B2
• Filed: 06/16/2010
• Issued: 02/05/2013
• Est. Priority Date: 06/16/2009
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Jenkins, Kimble L., Piferi, Peter, Vij, Kamal, Ghidoli, Daniele, Flores, Jesse
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US12/816,803
• Publication Number:
  US 20100317962A1
• Time in Patent Office: 965 Days
• Field of Search: 600407-429, 600473-480, 607119-123, 324/307, 324/309, 324/318
• US Class Current: 600/423
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• 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 5/0044 for the heart
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0127 : Magnetic means; Magnetic markers
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• 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

Abstract

An MRI-compatible catheter includes an elongated flexible shaft having opposite distal and proximal end portions. A handle is attached to the proximal end portion and includes an actuator in communication with the shaft distal end portion that is configured to articulate the shaft distal end portion. The distal end portion of the shaft may include an ablation tip and includes at least one RF tracking coil positioned adjacent the ablation tip that is electrically connected to an MRI scanner. The at least one RF tracking coil is electrically connected to a circuit that reduces coupling when the at least one RF tracking coil is exposed to an MRI environment. Each RF tracking coil is a 1-10 turn solenoid coil, and has a length along the longitudinal direction of the catheter of between about 0.25 mm and about 4 mm.

Claims

1. An MRI-compatible catheter, comprising:

an elongated flexible shaft having a distal end portion, and an opposite proximal end portion;

a handle attached to the proximal end portion, wherein the handle includes an electrical connector interface configured to be in electrical communication with an MRI scanner;

an ablation tip at the shaft distal end portion, wherein an RF conductor extends longitudinally within the shaft to the electrical connector interface at the handle and that connects the ablation tip to an RF generator; and

at least one RF tracking coil positioned adjacent the distal end portion, wherein the at least one tracking coil includes a conductive lead extending between the at least one RF tracking coil and the electrical connector interface and configured to electrically connect the at least one tracking coil to an MRI scanner, wherein the conductive lead has a length sufficient to define an odd harmonic/multiple of a quarter wavelength of the operational frequency of the MRI Scanner.

2. The device of claim 1, further comprising a thermocouple at the shaft distal end portion.

3. The device of claim 1, wherein the at least one RF tracking coil is electrically connected to a circuit that reduces coupling when the at least one RF tracking coil is exposed to an MRI environment.

4. The device of claim 1, wherein the at least one RF tracking coil comprises first and second RF tracking coils in adjacent spaced-apart relationship.

5. The device of claim 1, wherein the at least one RF tracking coil is a 1-10 turn solenoid coil.

6. The device of claim 1, wherein the at least one RF tracking coil has a length along the longitudinal direction of the catheter of between about 0.25 mm and about 4 mm

7. The device of claim 1, wherein the conductive lead is a coaxial cable.

8. The device of claim 1, wherein the at least one tracking coil comprises at least three spaced apart tracking coils, with at least two of the tracking coils being closely spaced together in fixed relationship on a substantially rigid distal end portion of the shaft.

9. The device of claim 1, wherein the RF conductor includes a series of back and forth segments along its length.

10. The device of claim 1, wherein the conductive lead includes a series of back and forth segments along its length.

11. The device of claim 1, wherein the at least one RF tracking coil is recessed within the catheter shaft.

12. The device of claim 11, wherein a layer of MRI-compatible material overlies the at least one RF tracking coil and is substantially flush with an outer surface of the catheter shaft.

13. The device of claim 1, wherein the shaft distal end portion comprises a biasing member that is configured to urge the shaft distal end portion to a non-articulated position.

14. The device of claim 13, wherein the biasing member is non-metallic.

15. The device of claim 1, further comprising at least one fluid exit port at the shaft distal end portion, wherein the at least one fluid exit port is in fluid communication with an irrigation lumen that extends longitudinally through the catheter shaft lumen from the at least one exit port to the proximal end portion of the catheter shaft.

16. The device of claim 15, wherein the irrigation lumen is in fluid communication with a fluid/solution source at the proximal end portion of the catheter shaft.

17. The device of claim 1, further comprising an actuator attached to the handle and in communication with the shaft distal end portion, wherein activation of the actuator causes articulation of the shaft distal end portion.

18. The device of claim 17, wherein the actuator comprises:

a piston movably secured to the handle and that is movable between extended and retracted positions relative the handle; and

a pull wire extending through a shaft lumen and having a distal end and an opposite proximal end, wherein the pull wire distal end is attached to the shaft distal end portion and the pull wire proximal end is attached to the piston, and wherein movement of the piston causes articulation of the shaft distal end portion.

19. The device of claim 17, wherein the pull wire is non-metallic and comprises single wire, a multi-filament wire, and/or a braided wire.

20. The device of claim 1, further comprising at least one sensing electrode at the shaft distal end portion.

21. The device of claim 20, wherein the at least one sensing electrode comprises a plurality of sensing electrodes arranged in spaced-apart relationship, and wherein an RF tracking coil is positioned between two adjacent sensing electrodes.

22. The device of claim 20, wherein the at least one sensing electrode comprises a resistor or resistive material.

23. An MRI-compatible catheter, comprising:

an elongated flexible shaft having a distal end portion, and an opposite proximal end portion;

a handle attached to the proximal end portion, wherein the handle includes an electrical connector interface configured to be in electrical communication with an MRI scanner;

at least one RF tracking coil positioned adjacent the distal end portion, wherein the at least one tracking coil includes a conductive lead extending between the at least one RF tracking coil and the electrical connector interface and configured to electrically connect the at least one tracking coil to an MRI scanner, wherein the conductive lead has a length sufficient to define an odd harmonic/multiple of a quarter wavelength of the operational frequency of the MRI Scanner; and

at least one RF shield coaxially disposed within the elongated shaft, the at least one RF shield comprising;

elongated inner and outer conductors, each having respective opposite first and second end portions; and

an elongated dielectric layer of MRI compatible material sandwiched between the inner and outer conductors and surrounding the inner conductor, wherein only the respective first end portions of the inner and outer conductors are electrically connected, and wherein the second end portions are electrically isolated.

24. The device of claim 23, wherein the inner and outer conductors each have a length of about twenty inches (20″

) or less.

25. The device of claim 23, wherein the inner and outer conductors each have a thickness of less than about 0.05 inches.

26. The device of claim 23, wherein the inner and outer conductors comprise conductive foil, conductive braid, or a film with a conductive surface.

27. The device of claim 23, wherein the at least one RF shield comprises a plurality of RF shields in end-to-end spaced-apart relationship.

28. An MRI-compatible catheter, comprising:

an elongated flexible shaft having a distal end portion, and an opposite proximal end portion;

a handle attached to the proximal end portion, wherein the handle includes an electrical connector interface configured to be in electrical communication with an MRI scanner; and

at least one RF tracking coil positioned adjacent the distal end portion, wherein the at least one tracking coil includes a conductive lead extending between the at least one RF tracking coil and the electrical connector interface and configured to electrically connect the at least one tracking coil to an MRI scanner, wherein the conductive lead has a length sufficient to define an odd harmonic/multiple of a quarter wavelength of the operational frequency of the MRI Scanner, wherein the at least one tracking coil is a plurality of spaced apart tuned tracking coils, each connected to a tuning circuit with a diode at a proximal end of the device using respective coaxial cables, and wherein the coaxial cables each have an electrical length in an MRI Scanner measured from the tracking coil to the diode that is about ¼

lambda or a higher odd harmonic thereof (¾

lambda, 5/4 lambda and the like), and wherein the circuit is configured to identify the location of the tracking coils with a precision of at least about 1 mm.

29. An MRI guided interventional system, comprising:

at least one catheter configured to be introduced into a patient via a tortuous and/or natural lumen path, comprising;

an elongated flexible shaft having a distal end portion, an opposite proximal end portion; and

at least one RF tracking coil connected to a channel of an MRI scanner via a conductive lead, and wherein the conductive lead has a length sufficient to define an odd harmonic/multiple of a quarter wavelength of the operational frequency of the MRI Scanner; and

a circuit adapted to communicate with and/or reside in the MRI scanner, the circuit configured to;

(a) obtain MR image data and generate a series of near real time (RT) MRI images of target anatomy of a patient during a surgical procedure using relevant anatomical scan planes associated with a 3-D MRI image space having a coordinate system;

(b) identify coordinates associated with a location of at least a distal end portion of the at least one catheter using the coordinate system of the 3-D MRI image space; and

(c) render near RT interactive visualizations of the at least one catheter in the 3-D image space with RT image data of target patient anatomical structure and a registered pre-acquired first volumetric model of the target anatomical structure of the patient, wherein the circuit illustrates the at least one catheter with a physical representation in the visualizations.

30. The system of claim 29, wherein the at least one catheter further comprises:

a handle attached to the proximal end portion;

an actuator attached to the handle and in communication with the shaft distal end portion, wherein activation of the actuator causes articulation of the shaft distal end portion; and

an ablation tip at the shaft distal end portion, wherein at least one RF tracking coil is positioned adjacent the ablation tip.

31. The system of claim 29, wherein the shaft distal end portion comprises a biasing member that is configured to urge the shaft distal end portion to a non-articulated position.

32. The system of claim 29, further comprising at least one sensing electrode at the shaft distal end portion.

33. The system of claim 29, further comprising a thermocouple at the shaft distal end portion.

34. The system of claim 29, further comprising at least one fluid exit port at the shaft distal end portion, wherein the at least one fluid exit port is in fluid communication with an irrigation lumen that extends longitudinally through the catheter shaft from the at least one exit port to the proximal end portion of the catheter shaft, and wherein the irrigation lumen is in fluid communication with a fluid/solution source at the proximal end portion of the catheter shaft.

35. The system of claim 29, wherein the at least one catheter further comprises:

a handle attached to the proximal end portion;

an actuator attached to the handle and in communication with the shaft distal end portion, wherein activation of the actuator causes articulation of the shaft distal end portion; and

a plurality of pairs of sensing electrodes arranged in spaced-apart relationship at the shaft distal end portion.

36. The system of claim 29, further comprising a display with a user interface in communication with the circuit configured to display the visualizations during an MRI guided interventional procedure, wherein the user interface is configured to allow a user to (a) rotate the visualizations and (b) alter a displayed visualization to include only a near RT image of the target anatomy, to include the near RT image of the anatomy and the registered model of the anatomical structure, or to include only the registered model of the anatomical structure.

37. The system of claim 29, wherein the MRI Scanner is configured to interleave signal acquisition of tracking signals from the at least one tracking coil with image data for the near RT MRI images, and wherein the circuit is configured to electronically track the at least one catheter in the 3-D image space independent of scan planes used to obtain the MR image data so that the at least one catheter is not required to be in any of the relevant anatomical scan planes used to obtain MR image data for the at least one near RT MRI image, and wherein the distal end portion of the at least one catheter can take on a curvilinear shape.

38. The system of claim 29, wherein the circuit is configured to calculate a device-tissue interface location proximate a tip location of the at least one catheter in the three dimensional image space, the circuit configured to project axially forward a defined distance beyond the tip to define the device-tissue interface, and wherein the calculated tissue interface location is used to automatically define at least one scan plane used to obtain the MR image data during and/or proximate in time to a procedure using the at least one catheter.

39. The system of claim 29, wherein the at least one tracking coil comprises at least three spaced apart tracking coils, with at least two of the tracking coils being closely spaced together in fixed relationship on a substantially rigid distal end portion of the shaft, and wherein the circuit is configured to direct the Scanner to snap-to a projected tissue-device interface that is at or a distance beyond a calculated location of the tip to use at least one scan plane to obtain near real time image data of the tissue-device interface based on tracking coil signal data from only the two distal tracking coils and a known spatial relationship between the two tracking coils.

40. The system of claim 29, wherein the at least one tracking coil is a plurality of spaced apart tuned tracking coils that are connected to a diode at a proximal end of the device using respective coaxial cables, wherein the coaxial cables each have an electrical length in the Scanner measured from the tracking coil to the diode that is about ¼

lambda or a higher odd harmonic thereof (¾

lambda, 5/4 lambda and the like), and wherein the circuit is configured to obtain tracking coil signals from two adjacent tracking coils in a fixed spatial relationship with each other with respective tracking signals that define a substantially constant and correct physical offset distance.