Implantable MRI compatible stimulation leads and antennas and related systems and methods

• US 8,509,876 B2
• Filed: 08/09/2005
• Issued: 08/13/2013
• Est. Priority Date: 08/09/2004
• Status: Active Grant

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Karmarkar, Parag V.
• Primary Examiner(s): Roy, Baisakhi
• Application Number:
  US11/573,226
• Publication Number:
  US 20080039709A1
• Time in Patent Office: 2,926 Days
• Field of Search: 600/424, 324/318, 324/322, 606/41
• US Class Current: 600/424
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• 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 34/20 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 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• 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 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

In vivo medical stimulation probes include an elongate lead having at least one stimulation electrode disposed on a distal portion thereof. The probes may include a plurality of axially spaced apart RF chokes disposed on and/or in an axially extending shielding layer of the lead in advance of the at least one electrode to inhibit induced RF current from forming and/or traveling along the shielding layer.

Claims

1. An in vivo medical stimulation probe, comprising:

an elongate lead having a length and at least one stimulation electrode disposed on a distal portion thereof, at least one axially exending conductor coupled to the at least one stimulation electrode, and an axially extending shielding layer surrounding the at least one conductor over at least a major length of the lead and terminating at a lead location that is in advance of the at least one stimulation electrode;

a plurality of RF chokes axially spaced apart along the length of the lead and disposed on and/or in the shielding layer in advance of the at least one electrode to inhibit induced RF current from forming and/or traveling along the shielding layer; and

an MRI antenna that is configured to collect and transmit signal data in response to an applied RF excitation pulse in an MRI scanner system, wherein the lead is MRI-compatible.

2. A medical stimulation probe according to claim 1, the lead further comprising a recording/sensing electrode disposed at the distal portion.

3. A medical stimulation probe according to claim 1, wherein the lead is a flexible lead, and wherein, the at least one stimulation electrode is a plurality of spaced apart stimulation electrodes and the at least one axially extending conductor is a plurality of conductors held in a core of the lead, a respective one for each electrode, and wherein the shielding layer is discontinuous and is configured to surround the conductors over at least a major length of the lead and terminate at a lead location that is in advance of the electrodes.

4. A medical stimulation probe according to claim 3, further comprising an axially extending primary inner shielding layer surrounding the core with the plurality of electrodes, wherein the discontinuous shielding layer is a second shielding layer that is generally cylindrically disposed over the primary inner shielding layer, and wherein the primary inner and second shielding layers both terminate at a distal location of the lead that precedes the electrodes.

5. A medical stimulation probe according to claim 4, further comprising a first insulating dielectric layer disposed between the conductors and the primary inner shielding layer, and a second insulting dielectric layer disposed between the primary inner shielding layer and the second shielding layer, wherein the conductors, the first and second insulating dielectric layers and the primary inner and second shielding layers comprise MRI compatible materials, and wherein the RF chokes are formed in the second shielding layer to provide an electrical length that is about λ

/4 or less, wherein λ

is an MRI wavelength.

6. A medical stimulation probe according to claim 5, the lead further comprising a bio- and MRI-compatible outer polymeric layer.

7. A medical stimulation probe according to claim 1, wherein the MRI antenna is a coaxial antenna having a signal receiving length of between about 1-4 cm.

8. A medical stimulation probe according to claim 1, wherein the lead is chronically implantable, and wherein the at least one electrode is a plurality of electrodes that are sized and configured to apply deep brain stimulation.

9. A medical stimulation probe according to claim 8, wherein the lead has a length that is greater than 10 cm.

10. A medical stimulation probe according to claim 1, further comprising a connector disposed at a proximal end portion of the probe, the connector configured to releasably serially attach to both an implantable pulse generator and an MRI scanner interface, thereby allowing bimodal operation of the lead.

11. A medical stimulation probe according to claim 1, wherein the lead is configured to have at least two operational modes, including a first MRI operational mode wherein the lead receives MRI signals from the MRI antenna and a second therapeutic operational mode wherein the lead delivers a stimulation pulse to the at least one electrode.

12. A medical stimulation probe according to claim 11, wherein the at least one electrode is a plurality of electrodes, at least one of which is configured as a recording/sensing electrode, and wherein the lead is configured to provide trimodal operation with a third operational mode wherein the lead receives micro-electrical signals from local tissue from the recording/sensing electrode.

13. A medical stimulation probe according to claim 11, wherein the MRI antenna is configured to receive signal from local tissue over about a distance of about 2.5 cm or less.

14. A medical stimulation probe according to claim 13, wherein the MRI antenna is axially spaced apart from a closest one of the at least one electrode a distance of about 1-4 cm.

15. A chronically implantable deep brain stimulation and MRI imaging probe system, comprising:

the in vivo medical stimulation probe of claim 1, wherein the MRI antenna has axially extending, radially spaced apart first and second shielding layers, wherein the second shielding layer corresponds to the axially extending shielding layer of the in vivo medical stimulation probe;

a stimulation circuit in communication with the at least one stimulation electrode;

a MRI signal receiver circuit in communication with the MRI antenna; and

a splitter circuit in communication with the stimulation and receiver circuits for electrically connecting either the MRI receive or stimulation circuit.

16. A deep brain stimulation and MRI imaging probe according to claim 15, further comprising a decoupling circuit to electrically decouple the MRI antenna during an MRI RF transmit operation.

17. A deep brain stimulation and MRI imaging probe according to claim 15, further comprising a plurality of axially spaced apart discontinuities in the second shielding layer.

18. A deep brain stimulation and MRI imaging probe according to claim 15, wherein the RF chokes comprise balun circuits.

19. A deep brain stimulation and imaging probe according to claim 15, further comprising a microrecording electrode for receiving microelectric signals associated with neural tissue.

20. A deep brain stimulation and imaging probe according to claim 15, wherein the lead of the in vivo medical stimulation probe merges into a connector at a proximal portion thereof, the connector configured to serially interchangeably engage an MRI scanner interface and an implantable pulse generator.

21. An MRI compatible deep brain stimulation, and MRI signal acquiring probe system comprising:

the in vivo medical stimulation probe of claim 1, wherein the at least one stimulation electrode comprises a plurality of electrodes disposed on the distal portion of the lead of the in vivo medical stimulation probe and the at least one axially extending conductor comprises a. plurality of axially extending conductors disposed in a core of the probe, a respective one of the conductors associated with each electrode, wherein the axially extending shielding layer of the in vivo medical stimulation probe comprises an axially extending inner shield surrounding the plurality of conductors for at least a major portion of the length of the conductors;

an axially extending second shield radially spaced apart above the inner shield;

an axially extending first insulating/dielectric layer disposed intermediate of the inner and second shields;

an RF transmit decoupling circuit in communication with the MRI antenna; and

at least one connector attached to the proximal portion of the probe body, configured to hold a conductor transmission line for each of the electrodes.

22. A system according to claim 21, wherein the connector is configured to attach to an MRI scanner having a splitter circuit for selectively operating the electrodes or the MRI antenna.

23. A system according to claim 21, further comprising an MRI interface that holds the RF transmit decoupling circuit, the MRI interface configured to connect the lead to an MRI scanner with the RF transmit decoupling circuit decoupling the MRI antenna during an MRI RF excitation transmission.

24. A system according to claim 23, wherein the RF transmit decoupling circuit comprises a matching and tuning decoupling circuit that engages an MRI scanner and decouples the electrodes.

25. A system according to claim 24, wherein the lead is configured to serially engage with an MRI scanner and an implantable pulse generator.

26. A system according to claim 25, wherein the implantable pulse generator is MRI-compatible.

27. A system according to claim 24, wherein the lead comprises at least one lumen and associated port configured to emit a therapeutic fluid to neural tissue.

28. A system according to claim 24, wherein the lead is configured to slidably enter a cannula with the connector held outside the cannula during deep brain placement.

29. A system according to claim 28, wherein the cannula is MRI-compatible.

30. A system according to claim 28, wherein the system is configured to operate with an MRI-compatible stereotactic guidance system during deep brain placement.

31. A system according to claim 21, wherein the RF transmit decoupling circuits is held the connector.

32. A system according to claim 21, further comprising a stimulation circuit coupled to the electrodes and a splitter circuit in communication with the RF transmit decoupling circuit and the stimulation circuit.

33. A system according to claim 32, wherein the stimulation circuit comprises a high pass filter disposed in a transmission path intermediate a stimulation source and the electrodes.

34. A system according to claim 33, wherein the stimulation circuit is configured to block RF signals at a resonant frequency associated with a magnetic field strength of a MRI system used to operate the MRI antenna.

35. A system according to claim 21, further comprising a splitter circuit having selective operative first and second electrical transmission paths associated with first and second operational modes, the first transmission path connecting the MRI antenna with the MRI scanner and decoupling the electrodes during MRI operation and the second transmission path connecting the electrodes with a stimulation or recording source during electrical stimulation or recording, respectively.

36. A system according to claim 35, wherein the splitter circuit is configured to act as a high pass filter during MRI operation to electrically isolate the second transmission path from the first transmission path.

37. A system according to claim 35, wherein the splitter circuit is held in an MRI interface that is releaseably attachable to the connector.

38. A system according to claim 37, wherein the splitter circuit is held in the connector.

39. A medical kit, comprising:

the in vivo medical stimulation probe of claim 1, the lead configured to have selective operative first and second electrical transmission paths associated with at least first and second operational modes, the first transmission path connecting the MRI antenna with an MRI scanner and decoupling the at least one stimulation electrode during MRI operation and the second transmission path connecting the at least one stimulation electrode with a stimulation, ablation or recording source during electrical stimulation, ablation or recording, respectively.

40. A medical kit according to claim 39, wherein the lead is configured and sized to be chronically implantable for deep brain stimulation.

41. A medical kit according to claim 39, wherein the lead comprises a connector at a proximal end portion thereof, the connector configured to engage a chronically implantable pulse generator in the second operational mode.

42. A medical kit according to claim 39, wherein the connector is configured to be in communication with an MRI scanner in the first operational mode.

43. A medical kit according to claim 42, wherein the connector is configured to connect to an MRI interface with a splitter circuit and RF transmit decoupler circuit with the MRI interface connecting to the MRI scanner.

44. A method of placing and operating a deep brain stimulation probe, comprising:

inserting the in vivo stimulation probe of claim 1 into a brain of a subject;

connecting the lead to an MRI scanner interface in communication with a splitter circuit having a first electric transmission path for MRI operation and a second electric transmission path for stimulation operation;

obtaining MRI signals associated with local neural tissue proximate the MRI antenna from the MRI antenna using the first transmission path;

placing the at least one electrode on the lead at a desired location in the brain based on the obtaining step;

then stimulating neural tissue with the at least one electrode using the second transmission path; and

configuring the lead to inhibit the formation and/or transmission of RF induced current, wherein, the stimulating and obtaining steps are carried out using the same lead.

45. A method according to claim 44, further comprising;

implanting the lead in the brain with the at least one electrode held at the desired location in the brain;

connecting the lead to an implantable pulse generator; and

stimulating the neural tissue with the at least one electrode based on a stimulation signal transmitted from the implantable pulse generator to provide a therapeutic treatment.

46. A method according to claim 44, wherein the placing step comprises inserting the lead through a bore of a MRI-compatible cannula body having increased rigidity relative to the lead, the cannula body extending through the skull into neural tissue.

47. A method according to claim 44, wherein the placing step is carried out using a sterotaxis guidance system with MRI fiducial markers.

48. A method according to claim 44, wherein the obtaining step is repeated and carried out in substantially real-time to track the location of the lead in the brain.

49. A method according to claim 44, wherein the lead comprises an axially extending lumen with at least one exit port, the method further comprising releasing a therapeutic fluid into the brain.

50. A method according to claim 44, wherein the obtaining step is repeated a plurality of times before the placing step, the method further comprising recording microelectric audio signals sensed from the at least one electrode and transmitting the audio signals to an external audio device intermediate at least some of the obtaining steps.

51. A method according to claim 50, wherein the MRI antenna and at least one electrode are decoupled during RF transmission in an MRI imaging session.

52. A method according to claim 44, wherein the at least one electrode is a plurality of electrodes, at least one of which is both a recording and stimulation electrode, and wherein the MRI antenna has a viewing length of between about 1-4 cm.

53. A method according to claim 44, further comprising splitting the operation of the lead into an MRI operation and a stimulation operation, wherein the at least one electrode has an electrical circuit transmission path that is different during stimulation and MRI operation.

54. A method according to claim 44, wherein the at least one electrode is a plurality of electrodes-and the method further comprises selectively attaching the connector to an MRI system or to an implantable pulse generator, depending on a desired operational mode.

55. A probe system, comprising:

an MRI compatible cannula having an axially extending bore; and

the in vivo medical stimulation probe of claim 1;

wherein the probe is configured to slidably extend through the cannula bore and wherein, in operation, the cannula and probe cooperate to define componentsf the MRI antenna.

56. A probe system according to claim 55, wherein the cannula is configured to be inserted into a burr hole placed in a patient'"'"'s skull, and wherein the probe is configured for deep brain placement.

57. A probe system according to claim 55, wherein the cannula comprises a plurality of generally concentric tubular members configured to define axially extending shielding layer disposed over an inner conductive core, with the shielding layer and core being insulated from each other.

58. A probe system according to claim 55, wherein the cannula comprises a conductive shielding layer that cooperates with the probe to define the MRI antenna during positioning to obtain MRI signals for MRI positional guidance.

59. A probe system according to claim 58, wherein the probe is configured to remain implanted in the body.

60. A system according to claim 55, the system further comprising a controlled placement system that is configured to determine the positional location of the probe when held at a target region in the brain.

61. An MRI compatible therapeutic stimulation probe comprising:

an elongate flexible probe body having an axially extending internal cavity disposed therein;

at least one electrode held by a distal portion of the probe body;

at least one conductive trace or wire disposed within the probe body and coupled to the at least one electrode and configured and arranged to conductively connect the at least one electrode to a source; and

at least one axially extending conductor, separate from the at least one conductive trace or wire, configured to slidably extend into the cavity of the probe body, the at least one conductor having increased rigidity relative to the probe body,

wherein, during positioning in a body, the at least one conductor cooperates with the probe body and defines an in vivo MRI antenna used to obtain MRI signals for MRI positional guidance, and wherein, after placement, the at least one conductor can be removed from the probe body, leaving the probe body and electrode in position in the body.

62. An MRI probe according to claim 61, wherein the at least one electrode is a plurality of electrodes, at least one of which configured as a sensing and stimulation electrode.

63. An MRI probe according to claim 62, wherein the at least one conductor is a plurality of attached insulated conductors.

64. An MRI probe according to claim 61, wherein the probe body comprises a shielding layer with a plurality of axially spaced apart RF chokes.

65. An MRI probe according to claim 64, wherein the probe body comprises a first insulating layer, a first shielding layer, a second insulating layer and a second shielding layer, and wherein the RF chokes are disposed in the second shielding layer.