Methods and apparatus for fabricating leads with conductors and related flexible lead configurations

• US 9,630,000 B2
• Filed: 02/01/2016
• Issued: 04/25/2017
• 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: Edelstein, William A., Bottomley, Paul A., Karmarkar, Parag V., Allen, Justin M., Piferi, Peter, Gore, Brian
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US15/012,692
• Publication Number:
  US 20160220812A1
• Time in Patent Office: 449 Days
• 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 implantable medical 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;

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

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

a plurality of insulated conductors extending along the lead and electrically coupling the electrodes to the contacts, each insulated conductor defining a plurality of current suppression modules covered by the outer layer of the biocompatible, non-conductive polymer material, each current suppression module comprising a first forward section that extends in a forward lengthwise direction, then turns into a reverse section that extends in a reverse lengthwise direction opposite the forward lengthwise direction, then turns into a second forward section that extends in the forward lengthwise direction, wherein at least one of the first forward section, the reverse section, or the second forward section comprises a coil.

2. The lead of claim 1, wherein each insulated conductor electrically couples one of the electrodes to one of the contacts.

3. The lead of claim 1, wherein the first forward section, the reverse section, and the second forward section overlap.

4. The lead of claim 1, wherein each of the first forward section, the reverse section, and the second forward section comprises a coil.

5. The lead of claim 4, wherein at least two of the coils interleave.

6. The lead of claim 5, wherein exactly two of the coils interleave.

7. The lead of claim 6, wherein the two interleaved coils are disposed around a third one of the coils.

8. The lead of claim 4, wherein the coils of the first forward section, the reverse section, and the second forward section form a stack with a first one of the coils being an inner layer coil, a second one of the coils being an intermediate layer coil disposed around the inner layer coil, and a third one of the coils being an outer layer coil disposed around the intermediate layer coil.

9. The lead of claim 8, wherein the coil of the reverse section is the intermediate layer coil.

10. The lead of claim 1, wherein the reverse section comprises the coil.

11. The lead of claim 10, wherein the first forward section, the reverse section, and the second forward section form a stack.

12. The lead of claim 11, wherein the reverse section is between the first forward section and the second forward section in the stack.

13. The lead of claim 11, wherein a portion of at least one of the first forward section or the second forward section passes through the coil of the reverse section.

14. An implantable medical lead having a proximal end and a distal end, the lead comprising:

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

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

a plurality of insulated conductors extending along the lead and electrically coupling the electrodes to the contacts, each insulated conductor defining a plurality of current suppression modules, each current suppression module comprising a first forward section that extends in a forward lengthwise direction and comprises a first coil, then turns into a reverse section that extends in a reverse lengthwise direction opposite the forward lengthwise direction and comprises a second coil, then turns into a second forward section that extends in the forward lengthwise direction and comprises a third coil, wherein the first, second, and third coils form a stack.

15. The lead of claim 14, wherein two of the first coil, the second coil, or the third coil interleave.

16. The lead of claim 15, wherein one of the first coil or the third coil is interleaved with the second coil.

17. The lead of claim 14, wherein a first one of the first coil, the second coil, or the third coil is an inner layer coil, a second one of the first coil, the second coil, or the third coil is an intermediate layer coil disposed around the inner layer coil, and a third one of the first coil, the second coil, or the third coil is an outer layer coil disposed around the intermediate layer coil.

18. The lead of claim 17, wherein the second coil is the intermediate layer coil.

19. The lead of claim 14, wherein each insulated conductor electrically couples one of the electrodes to one of the contacts.

20. The lead of claim 14, further comprising an outer layer of a biocompatible, non-conductive polymer material disposed around and covering each of the current suppression modules.