MRI and RF compatible leads and related methods of operating and fabricating leads

• US 9,492,651 B2
• Filed: 03/13/2008
• Issued: 11/15/2016
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation), MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation), MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Bottomley, Paul A., Karmarkar, Parag V., Allen, Justin M., Edelstein, William A.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US12/047,602
• Publication Number:
  US 20080243218A1
• Time in Patent Office: 3,169 Days
• Field of Search: 607/63, 607/115, 607/116, 607/117, 607/119, 607/122
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0565 Electrode heads
• 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: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

RF/MRI compatible leads include at least one conductor that turns back on itself at least twice in a lengthwise direction, and can turn back on itself at least twice at multiple locations along its length. The at least one electrical lead can be configured so that the lead heats local tissue less than about 10 degrees Celsius (typically about 5 degrees Celsius or less) or does not heat local tissue when a patient is exposed to target RF frequencies at a peak input SAR of at least about 4 W/kg and/or a whole body average SAR of at least about 2W/kg. Related devices and methods of fabricating leads are also described.

Claims

1. An MRI/RF compatible medical lead system, comprising:

a lead having, a proximal end portion, a distal end portion, and a length extending from the proximal end portion to the distal end portion, the lead comprising at least one electrode disposed along the distal end portion of the lead and at least one conductor having a length with opposing proximal and distal end portions. wherein each conductor of the at least one conductor is configured with a plurality of current suppression modules along the length thereof, wherein each current suppression module comprises a first forward segment extending in a forward lengthwise direction, relative to the length of the lead toward the at least one electrode, a reverse segment that turns away from the first forward segment and extends in an opposing reverse lengthwise direction, relative to the length of the lead, opposite the forward lengthwise direction, and a second forward segment that turns away from the reverse segment and extends in the forward lengthwise segment, wherein the first forward segment, reverse segment, and second forward segment form a transversely stacked arrangement of lengthwise extending segments; and

at least one contact disposed along the proximal end portion of the lead;

wherein the at least one conductor electrically couples the at least one contact to the at least one electrode and wherein each conductor of the at least one conductor comprises a wire that extends continuously from at least one of the at least one contact to at least one of the at least one electrode.

2. A medical lead system according to claim 1, wherein the at least one conductor comprises a first conductor with a plurality of the current suppression modules serially arranged along at least half of a physical length of the first conductor.

3. A medical lead system according to claim 2 wherein the first conductor has a constant nonadjustable physical length.

4. A medical lead system according to claim 1, wherein the lead system heats local tissue less than about 10 degrees Celsius when exposed to RF associated with an MRI Scanner at a peak input SAR of between about 4 W/kg to about 10 W/kg and/or a whole body average SAR input of between about 2-5 W/kg.

5. A medical lead system according to claim 1, wherein some of the current suppression modules have at least one coiled portion forming at least a portion of one or more of the first forward segment, the second forward segment or the reverse segment.

6. A medical lead system according to claim 1, wherein at least some of the current suppression modules are configured so that a respective conductor turns on itself to reside above, below or through a coiled portion thereof.

7. A medical lead system according to claim 1, wherein the lead comprises a serpentine shape of a plurality of closely spaced lead turns that define a plurality of reverse segments, with each neighboring pair of reverse segments separated by a forwardly extending segment, wherein the serpentine reverse segments reside proximate each other along a substantially common lengthwise portion of the lead.

8. A medical lead system according to claim 1, wherein at least one of the reverse, first forward, or second forward segments extends under, over or through a coiled one of the first forward, second forward, or reverse segments.

9. A medical lead system according to claim 1, wherein the at least one conductor is a plurality of conductors, and wherein the at least one electrode is a plurality of electrodes, and wherein one or more of the conductors are in electrical communication with each of the electrodes.

10. A medical lead system according to claim 1, wherein the at least one conductor is a plurality of conductors, and wherein the at least one electrode is a plurality of electrodes, and wherein at least two conductors are in electrical communication with each of the electrodes.

11. A medical lead system according to claim 1, wherein each current suppression module has the first and second forward segments with an electrical length that is about λ

/4 or less in an MRI scanner, and wherein the reverse segment has an electrical length that is substantially the same, less or greater than that of at least one of the first or second forward segments.

12. A medical lead system according to claim 11, wherein the reverse segment has a lengthwise physical length that is substantially the same or less than that of a lengthwise physical length of at least one of the first or second forward segments.

13. A medical lead system according to claim 1, further comprising an implantable pulse generator (IPG) in communication with the at least one conductor of the lead system, with the IPG configured to provide an electrical stimulation or pacing signal to the at least one electrode through the at least one conductor.

14. A medical lead system according to claim 1, wherein at least some of the plurality of current suppression modules of the at least one conductor are proximately spaced apart in a lengthwise direction.

15. A medical lead system according to claim 1, wherein at least some of the plurality of current suppression modules of the at least one conductor are irregularly or regularly spaced apart in a lengthwise direction.

16. A medical lead system according to claim 1, wherein at least some of the current suppression modules have a configuration that is repeated over a length of the conductor.

17. A medical lead system according to claim 1, wherein some of the current suppression modules have a different physical and/or electrical length than others.

18. A medical lead system according to claim 1, wherein the at least one conductor is insulated, the lead system further comprising an electrical insulator and/or RF shield of biocompatible material disposed over an external surface of the lead system.

19. A lead having a proximal end and a distal end, the lead comprising:

an outer layer of a biocompatible polymer material extending from the proximal end to the distal end of the lead;

at least one contact disposed along the proximal end of the lead;

at least one electrode disposed along the distal end of the lead; and

at least one conductor with each conductor having a plurality of spaced apart current suppression modules formed by the conductor, wherein at least one of the current suppression modules comprises a length of the conductor having a plurality of closely spaced conductor portions in a serpentine shape with respect to the outer layer, wherein the conductor portions comprise a first conductor portion, a second conductor portion, and a third conductor portion, wherein the first conductor portion extends toward the distal end of the lead and turns into the second conductor portion that extends away from the distal end of the lead and then turns into the third conductor portion that extends toward the distal end of the lead, wherein the first conductor portion, second conductor portion, and third conductor portion form a transversely stacked arrangement of lengthwise extending conductor portions, wherein the at least one conductor electrically couples the at least one contact to the at least one electrode and wherein each conductor of the at least one conductor comprises a wire that extends continuously from at least one of the at least one contact to at least one of the at least one electrode.

20. A lead according to claim 19, wherein one of the first conductor portion, second conductor portion, or third conductor portion comprises a coiled portion with at least one other of the first conductor portion, second conductor portion, or third conductor portion residing inside, outside or through the coiled portion.

21. A lead according to claim 19, wherein the conductor portions in the serpentine shape have a lengthwise physical distance of between about 0.5 cm to about 10 cm.

22. A lead according to claim 19, wherein the lead comprises an electrical shield, and wherein at least some of the serpentine conductor portions are unshielded to thereby increase RF-induced current deposited on the serpentine conductor portions relative to other conductor portions when exposed to RF associated with an MRI scanner.

23. A lead according to claim 19, wherein the conductor comprises first and second forward portions, extending forwardly toward the at least one electrode, at at least some opposing end portions of the serpentine shaped conductor portions, and wherein the first and second forward portions have increased insulation relative to the conductor portions in the serpentine shape.

24. A lead according to claim 19, wherein at least some of the conductor portions defining the serpentine shape are capacitively coupled together.

25. A lead according to claim 19, wherein the lead is a medical lead, wherein the at least one conductor is a plurality of conductors and wherein each of the conductors comprise a plurality of the current suppression modules with serpentine shapes with the respective serpentine shapes being longitudinally spaced apart.

26. An MRI safe lead system, comprising:

an elongate flexible lead having a proximal end portion and a distal end portion, the lead comprising a plurality of conductors having a length with opposing proximal and distal end portions, wherein each conductor contains a plurality of current suppression modules along the length of each conductor, each current suppression module comprising at least one coiled segment of the conductor;

a plurality of contacts disposed along the proximal end portion of the lead; and

a plurality of electrodes disposed along the distal end portion of the lead, the conductors electrically coupling at least one of the contacts to at least one of the electrodes, wherein each conductor of the plurality of conductors comprises a wire that extends continuously from at least one of the contacts to at least one of the electrodes.

27. A lead system according to claim 26, wherein the lead system is configured to inhibit undesired temperature rise in local tissue to less than about 10 degrees Celsius when exposed to RF frequencies associated with an MRI scanner at a peak SAR input of between about 4 W/kg to at least about 10 W/kg and/or a whole body average SAR of between about 2 W/kg to at least about 5 W/kg.

28. A lead system according to claim 26, wherein corresponding sets of first forward, second forward, and reverse segments of a respective current suppression module have an electrical length of about λ

/4 or less in an MRI scanner, and wherein the first and second forward segments have a lengthwise physical length of between about 1-25 cm, and wherein the reverse segments have a lengthwise physical length of between about 1-25 cm.

29. A lead system according to claim 28, Wherein the reverse segments of the current suppression modules have a physical length that is between about 30-70% that of a physical length of an adjacent one of the first or second forward segments.

30. A lead system according to claim 28, wherein the plurality of conductors is between about 2-100, and wherein the conductors are configured so that the coiled segments of at least some of the first forward, second forward and/or reverse segments of the current suppression modules are cowound with at least one other conductor.

31. A lead system according to claim 26, wherein the plurality of current suppression modules is between about 4-40.

32. A lead system according to claim 26, wherein the plurality of current suppression modules is between about 6-20.

33. A lead system according to claim 26, wherein the lead is between about 1 French to about 10 French.

34. A lead system according to claim 26, wherein the conductors comprise a distal end portion with at least one of the current suppression modules that terminates into a coiled segment that connects to one of the electrodes.