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

• US 8,768,433 B2
• Filed: 12/21/2012
• Issued: 07/01/2014
• 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
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US13/723,612
• Publication Number:
  US 20130116543A1
• Time in Patent Office: 557 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-guided medical device includes an elongated sheath, an elongated dilator, and an elongated needle. The sheath has a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends. The sheath comprises MRI-compatible material and includes a tracking member located adjacent to the sheath distal end that is visible in an MRI image. The dilator comprises MRI-compatible material and is movably disposed within the sheath lumen. A distal end of the dilator is configured to extend outwardly from the sheath distal end and dilator includes at least one tracking member that is visible in an MRI image. The needle is movably disposed within the dilator lumen and is movable between stored and operative positions relative to the dilator. An RF shield may be coaxially disposed within the elongated sheath so as to surround a portion of the sheath central lumen.

Claims

1. An MRI-compatible medical device, comprising:

an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end;

a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and

a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of an MRI-compatible material and a tip portion, wherein the tip portion is located at the needle distal end, wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position, wherein the needle tip portion includes a tracking member that is closely spaced-apart from the at least one tracking member on the dilator distal end when the needle is in the extended position.

2. The device of claim 1, wherein a portion of the sheath adjacent the sheath distal end has a generally curved configuration.

3. The device of claim 1, wherein the at least one tracking member adjacent the sheath distal end comprises a coating of MRI visible material on the sheath.

4. The device of claim 1, wherein the at least one tracking member adjacent the sheath distal end comprises at least one RF coil.

5. The device of claim 1, wherein the at least one tracking member adjacent the dilator distal end comprises at least one RF coil.

6. The device of claim 1, wherein the at least one tracking member adjacent the dilator distal end comprises a pair of RF coils in adjacent spaced-apart relationship.

7. The device of claim 5, wherein the at least one RF coil adjacent the dilator distal end is embedded within a wall of the dilator.

8. The device of claim 1, wherein the needle tip portion comprises multiple sections of conductive and non-conductive material alternately connected together.

9. The device of claim 1, wherein the needle tip portion comprises a plurality of sections of different diameters arranged in a telescopic configuration.

10. The device of claim 1, wherein the needle tip portion comprises a coating of material.

11. The device of claim 1, wherein a portion of the needle adjacent the needle distal end has a generally curved configuration.

12. The device of claim 1, wherein the needle tip portion is deformable.

13. The device of claim 1, further comprising a guidewire having a distal end, and an opposite proximal end, wherein the guidewire includes at least one tracking member adjacent the guidewire distal end, and wherein the guidewire is configured to be movably disposed within the dilator lumen when the needle is absent therefrom.

14. An MRI-compatible medical device, comprising:

an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end;

a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MM scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and

a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of an MM-compatible material and a tip portion, wherein the tip portion is located at the needle distal end, wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position.

15. The device of claim 14, wherein the needle tip portion includes a tracking member that is closely spaced-apart from the at least one tracking member on the dilator distal end when the needle is in the extended position.

16. The device of claim 14, wherein the at least one tracking member adjacent the sheath distal end comprises a coating of MM visible material on the sheath.

17. The device of claim 14, wherein the at least one tracking member adjacent the sheath distal end comprises at least one RF coil.

18. The device of claim 14, wherein the at least one tracking member adjacent the dilator distal end comprises at least one RF coil.

19. The device of claim 14, wherein the at least one tracking member adjacent the dilator distal end comprises a pair of RF coils in adjacent spaced-apart relationship.