Methods and apparatus for fabricating leads with conductors and related flexible

• US 9,248,270 B2
• Filed: 03/13/2008
• Issued: 02/02/2016
• 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: Karmarkar, Parag V., Bottomley, Paul A., Allen, Justin M., Edelstein, William A., Piferi, Peter, Gore, Brian
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US12/047,832
• Publication Number:
  US 20080262584A1
• Time in Patent Office: 2,882 Days
• Field of Search: 607/116, 607/121, 607/122, 174/32
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0488 Details about the lead
• 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 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: B29C 33/126 using centering means forming part of the insert
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: G01N 3/32 by applying repeated or pulsating forces
• CPC Class Codes: Y10T 29/49071 by winding or coiling

Abstract

MRI/RF compatible leads include at least one conductor, a respective conductor having at least one segment with a multi-layer stacked coil configuration. The 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 leads and methods of fabricating leads are also described.

Claims

1. An RF/MRI compatible lead having a proximal end and a distal end, the lead comprising:

an outer layer of a biocompatible, non-conductive polymer material extending along a portion of the lead;

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

at least one insulated conductor extending along the lead and electrically coupled to the at least one electrode, each of the at least one insulated conductor having a length with opposing distal and proximal end portions, each of the at least one insulated conductor having at least one segment with a multi-layer coil configuration, each multi-layer coil configuration being covered by the outer layer of the biocompatible, non-conductive polymer material and being formed from a single one of the at least one insulated conductor and comprising a first forward coiled section that extends in a forward lengthwise direction for a first forward physical length, then turns to merge into a proximately positioned reverse coiled section that extends in a substantially opposing reverse lengthwise direction for a reverse physical length, then turns to merge into a proximately positioned second forward coiled section that extends in the forward lengthwise direction for a second forward physical length, wherein the first forward coiled section, reverse coiled section, and second forward coiled section of the multi-layer coil configuration are each part of the single one of the at least one insulated conductor,

wherein the lead is flexible and is configured and arranged for insertion into a body of a patient.

2. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least two of the first forward section, the second forward section, and the reverse coiled section have substantially constant diameter coil configurations.

3. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section, the second forward coiled section and the reverse coiled section are substantially concentric.

4. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least some revolutions of the first forward and reverse coiled sections reside proximate each other in a side-to-side lengthwise orientation.

5. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, at least some revolutions of the reverse coiled section reside proximate and over the first forward coiled section.

6. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, 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.

7. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section extends in the forward lengthwise direction about a central axis and has a pitch such that serial revolutions of the first forward coiled section are spaced apart in a lengthwise direction to define gaps, and wherein the reverse coiled section extends about the central axis and has a pitch such that revolutions thereof substantially reside in the gaps of the first forward coiled section.

8. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, the second forward coiled section has more revolutions than that of the first forward and the reverse coiled sections.

9. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, 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 conductor coil configuration.

10. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section and the reverse coiled section reside on a substantially common layer and the second forward coiled section resides over the first forward and reverse coiled sections to define a two-layer stacked conductor coil configuration.

11. A lead according to claim 1, wherein, for the multi-layer coil configuration of at least one of the at least one segment, the first forward coiled section and the reverse coiled section have substantially the same pitch, and wherein the second forward coiled section has a smaller pitch than that of the first and reverse coiled sections.

12. A lead according to claim 1, wherein each of the at least one conductor has at least one segment with a multi-layer stacked coil configuration of at least one set of the first and second forward coiled sections and the reverse coiled section.

13. A lead according to claim 12, wherein, for the multi-layer coil configuration of at least one of the at least one segment of at least one of the plurality of conductors, the first forward coiled section and the reverse coiled section have substantially the same pitch, and wherein the second forward coiled section has a smaller pitch than that of the first and reverse coiled sections.

14. A lead according to claim 1, wherein at least one segment of the multi-layer coil configuration has more than three layers of stacked coils.

15. A lead according to claim 1, wherein the at least one conductor is a plurality of conductors wherein each of the conductors are insulated along an entire length of the lead forming the multi-layer coil configuration.

16. A lead according to claim 1, wherein the lead has a length and at least a major portion of the length of the lead has a substantially constant outer diameter.

17. A lead according to claim 1, further comprising an elongate inner flexible sleeve residing about a central lengthwise axis with the multi-layer coil configuration encircling the sleeve.

18. A lead according to claim 1, wherein the at least one conductor includes a conductor that has a cross-sectional width of between about 0.0001 inches to about 0.2 inches.

19. A lead according to claim 1, wherein the lead is an MRI/MRS compatible implantable medical lead.

20. A lead according to claim 1, wherein the at least one conductor is a plurality of conductors and the at least one electrode is a plurality of electrodes.

21. A lead according to claim 20, wherein each of the plurality of electrodes is electrically coupled to a different one of the plurality of conductors.

22. A lead according to claim 1, wherein each of the at least one conductor has low DC resistance.

23. A lead according to claim 1, wherein the conductor has at least two segments of the multi-layer coil configuration, and wherein a forward section on a top layer of one multi-layer coil configuration in one segment merges into a forward section on a bottom layer of the other segment.

24. A lead according to claim 1, wherein the at least one conductor is a plurality of conductors, and wherein each of the plurality of conductors is a continuous length of conductor.

25. A lead according to claim 1, wherein the at least one conductor has a plurality of the multi-layer coil configurations serially arranged so that one multi-layer coil configuration segment merges into the next adjacent multi-layer coil configuration along the length of the conductor, each of the multi-layer coil configurations having a length that is less than about 15 cm, and wherein the lead has low DC resistance.

26. A lead according to claim 1, wherein the at least one conductor is a plurality of conductors configured so that at least one multi-layer coil configuration of a first conductor of the plurality of conductors has first forward, reverse, and second forward coiled sections that are substantially concentric to first forward, reverse, and second forward coiled sections of at least one multi-layer coil configuration of a second conductor of the plurality of conductors.

27. A lead according to claim 1, wherein the at least one conductor is a plurality of conductors configured so that one multi-layer coil configuration of a first conductor of the plurality of conductors resides downstream or upstream of one multi-layer coil configuration of a second conductor of the plurality of conductors along a length of the lead.

28. A lead according to claim 1, wherein the at least one conductor is between about 1-100 conductors.

29. A lead according to claim 28, wherein each of at least a majority of the conductors has a plurality of the multi-layer coil configurations, and wherein the at least one conductor has between about 4-100 multi-layer coil configurations along the length thereof.

30. A lead according to claim 1, wherein the at least one conductor comprises first and second conductors, each of the first and second conductors having a plurality of segments with the multi-layer coil configuration, and wherein the segments of the multi-layer coil configurations of the first conductor alternate along the length of the lead with those of the segments of the multi-layer coil configurations of the second conductor.

31. A lead according to claim 1, wherein the lead is sufficiently flexible such that when grasped or suspended at a medial location, opposing long sides and/or end portions thereof drape or droop together.

32. A lead according to claim 1, wherein the at least one conductor comprises a single layer coil extension extending from a segment having a multi-layer coil configuration to an electrode residing upstream thereof.

33. A lead according to claim 1, wherein the lead is configured and arranged for implantation in a patient.

34. An RF/MRI compatible lead comprising:

a plurality of conductors, each of the plurality of conductors having a length with opposing distal and proximal end portions, each of the plurality of conductors having at least one segment with a multi-layer coil configuration, each multi-layer coil configuration being formed from a single one of the plurality of conductors and comprising a first forward coiled section that extends in a forward lengthwise direction for a first forward physical length, then turns to merge into a proximately positioned reverse coiled section that extends in a substantially opposing reverse lengthwise direction for a reverse physical length, then turns to merge into a proximately positioned second forward coiled section that extends in the forward lengthwise direction for a second forward physical length, wherein the first forward coiled section, reverse coiled section, and second forward coiled section of the multi-layer coil configuration are each part of the single one of the plurality of conductors; and

at least one electrode with one or more of the plurality of conductors in communication with the at least one electrode, wherein the lead is configured so that the lead heats local tissue less than about 10 degrees Celsius or does not heat local tissue when a patient is exposed to target RF frequencies generating a peak input SAR of between about 4 W/kg to about 10 W/kg and/or whole body average SAR of between about 2 W/kg to about 4 W/kg.

35. An RF/MRI compatible lead comprising:

a plurality of conductors, each of the plurality of conductors having a length with opposing distal and proximal end portions, each of the plurality of conductors having at least one segment with a multi-layer coil configuration, each multi-layer coil configuration being formed from a single one of the plurality of conductors and comprising a first forward coiled section that extends in a forward lengthwise direction for a first forward physical length, then turns to merge into a proximately positioned reverse coiled section that extends in a substantially opposing reverse lengthwise direction for a reverse physical length, then turns to merge into a proximately positioned second forward coiled section that extends in the forward lengthwise direction for a second forward physical length, wherein the first forward coiled section, reverse coiled section, and second forward coiled section of the multi-layer coil configuration are each part of the single one of the plurality of conductors; and

at least one electrode with one or more of the plurality of conductors in communication with the at least one electrode, wherein the electrical lead heats local tissue less than about 5 degrees Celsius when exposed to target RF frequencies associated with MR Scanners at a peak input SAR of between about 4-10 W/kg and/or a whole body average SAR of between about 2-5 W/kg.

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

an outer layer of a biocompatible, non-conductive polymer material extending along a portion of the lead;

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

at least first and second insulated conductors extending along the lead and electrically coupled to the at least one electrode, the first and second conductors having at least one multi-layer stacked cowound coil configuration, wherein, for each multi-layer stacked cowound coil configuration, each of the first and second conductors, including the at least one multi-layer stacked cowound coil configuration, being covered by the outer layer of the biocompatible, non-conductive polymer material and having individually a first forward coiled section that extends in a forward lengthwise direction for a first forward physical length, that then turns in a lengthwise direction to merge into a proximately positioned reverse coiled section that extends in a substantially opposing reverse lengthwise direction for a reverse physical length, and that then turns in the lengthwise direction to merge into a proximately positioned second forward coiled section that extends in the forward lengthwise direction,

wherein the medical lead is flexible and is configured and arranged for insertion into a body of a patient.

37. A medical lead according to claim 36, wherein each of the first and second conductors connect to the same electrode.

38. A medical lead according to claim 36, wherein the at least one electrode comprises a plurality of electrodes, and wherein the first and second conductors connect to a different electrode.

39. A medical lead according to claim 36, wherein the medical lead is configured and arranged for implantation in a patient.