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

• US 10,391,307 B2
• Filed: 11/15/2016
• Issued: 08/27/2019
• Est. Priority Date: 03/19/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Bottomley, Paul A., Karmarkar, Parag V., Allen, Justin M., Edelstein, William A.
• Primary Examiner(s): Bertram, Eric D.
• Assistant Examiner(s): Bays, Pamela M.
• Application Number:
  US15/352,514
• Publication Number:
  US 20170113036A1
• Time in Patent Office: 1,015 Days
• Field of Search: 607115, 607122
• 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 2 W/kg. Related devices and methods of fabricating leads are also described.

Claims

1. A flexible medical lead, comprising:

an elongate flexible lead body of a biocompatible polymer material, the lead body having a length with a proximal end portion and a distal end portion;

a plurality of electrodes disposed along the distal end portion of the lead body;

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

at least one conductor, wherein each of the at least one conductor is continuous and is electrically coupled to at least one of the electrodes and at least one of the contacts and comprises a plurality of segments, each segment comprising a multi-layer stacked coil configuration, each multi-layer stacked coil configuration comprising a first forward coiled section that extends in a forward lengthwise direction, then turns back into a reverse coiled section that extends in a substantially opposing reverse lengthwise direction, then turns back into a second forward coiled section that extends in the forward lengthwise direction, wherein the first forward coiled section, reverse coiled section, and second forward coiled section form a plurality of layers stacked over each other.

2. The flexible medical lead of claim 1, wherein the at least one conductor is a plurality of conductors.

3. The flexible medical lead of claim 1, wherein each of the at least one conductor is attached to at least one of the contacts and at least one of the electrodes.

4. The flexible medical lead of claim 1, wherein the first forward coiled section resides on a first layer, the reverse coiled section resides on a second layer over the first layer, and the second forward coiled section resides on a third layer over the second layer to define a three-layer stacked coil configuration.

5. The flexible medical lead of claim 1, wherein the first forward coiled section and the reverse coiled section reside on a first layer and the second forward coiled section resides on a second layer over the first layer to define a two-layer stacked coil configuration.

6. The flexible medical lead of claim 1, wherein the first forward coiled section, the reverse coiled section, and the second forward coiled section are concentric.

7. The flexible medical lead of claim 1, further comprising an elongate inner flexible sleeve residing about a central lengthwise axis with the multi-layer stacked coil configurations encircling the sleeve.

8. The flexible medical lead of claim 1, wherein each of the at least one conductor has between about 4-100 multi-layer stacked coil configurations.

9. The flexible medical lead of claim 1, wherein each of the at least one conductor has at least two of the multi-layer stacked coil configurations, and wherein a second forward coiled section on a top layer of one of the multi-layer stacked coil configurations leads to a first forward coiled section on a bottom layer of another one of the multi-layer stacked coil configurations.

10. The flexible medical lead of claim 1, wherein the at least one conductor comprises first and second conductors, each having a plurality of segments with the multi-layer stacked coil configuration, and wherein the segments of the multi-stacked coil configurations of the first conductor alternate along a length of the lead with those of the segments of the multi-layer stacked coil configurations of the second conductor.

11. The flexible medical lead of claim 1, wherein each of the multi-layer stacked coil configurations is a current suppression module.

12. The flexible medical lead of claim 11, wherein each of the current suppression modules is configured and arranged to substantially suppress current induced by RF utilized during an MRI procedure.

13. The flexible medical lead of claim 1, wherein at least one of the first forward coiled section, reverse coiled section, or second forward coiled section of at least one of the multi-layer stacked coil configurations has an electrical length of λ

/4 or less in an MRI scanner.

14. The flexible medical lead of claim 1, wherein each of the at least one conductor comprises at least four of the multi-layer stacked coil configurations.

15. The flexible medical lead of claim 1, wherein each of the at least one conductor comprises a single layer extension from one of the segments having the multi-layer stacked coil configuration, wherein the single layer extension is attached to one of the electrodes.

16. The flexible medical lead of claim 1, wherein each of the at least one conductor is insulated along an entire length of the multi-layer stacked coil configurations of that conductor.

17. The flexible medical lead of claim 1, wherein, for the multi-layer stacked coil configuration of at least one of the segments, at least some revolutions of the reverse coiled section are interleaved with at least some revolutions of at least one of the first or second forward coiled sections.

18. The flexible medical lead of claim 1, wherein, for the multi-layer stacked coil configuration of at least one of the segments, at least two of the first forward coiled section, the second forward coiled section, and the reverse coiled section have a constant coil diameter.

19. The flexible medical lead of claim 1, wherein, for at least one of the at least one conductor, the multi-layer stacked coil configurations are serially arranged along at least half of a physical length of the conductor.

20. The flexible medical lead of claim 1, wherein, for the multi-layer stacked coil configuration of at least one of the segments, the second forward coiled section leads into the first forward coiled section of another one of the multi-layer stacked coil configurations.