MRI conditionally safe lead with multi-layer conductor

• US 8,798,767 B2
• Filed: 11/05/2010
• Issued: 08/05/2014
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Foster, Arthur J., Perrey, Christopher, DeRoche, Stephen Earl
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/940,592
• Publication Number:
  US 20110160829A1
• Time in Patent Office: 1,369 Days
• Field of Search: 607 1- 2, 607115-116, 600372-373, 600/377
• US Class Current: 607/116
• 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 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

An implantable medical lead exhibits reduced heating under MRI conditions. The lead includes a multi-layer coil conductor including an inner coil layer, a middle coil layer disposed around the inner coil layer, and an outer coil layer disposed around the middle coil layer. Each of the coil layers is characterized by one or more of a filar thickness, a coil pitch, or a coil diameter configured such that the coil conductor exhibits a high inductance when exposed to MRI radiation. Each of the coil layers is electrically connected to the other coil layers to provide parallel conductive paths resulting in a coil conductor resistance suitable for defibrillation lead applications.

Claims

1. An implantable electrical lead, comprising:

a flexible body having a proximal region including a proximal end, a distal region, and a longitudinal body lumen extending from the proximal end through the distal region;

a connector assembly configured to mechanically and electrically connect the implantable electrical lead to an implantable pulse generator;

an electrode coupled to the flexible body in the distal region; and

a multi-layer coil conductor extending within the longitudinal body lumen from the connector assembly to at least the electrode, the multi-layer coil conductor configured to minimize heat rise when exposed to magnetic resonance imaging (MRI) scans, the multi-layer coil conductor including;

a first coil layer including one or more filars wound so as to have a close pitch; and

a second coil layer disposed about the first coil layer including one or more filars wound so as to have a close pitch, the second coil layer having a proximal end at the connector assembly and a distal end at the electrode, the second coil layer defining a lumen within which the first coil layer extends from the proximal end to the distal end, the filars of the second coil layer wound in the same pitch direction as the filars of the first coil layer from the proximal end to the distal end; and

wherein the first and second coil layers are electrically coupled to one another and configured to provide parallel conductive paths between the connector assembly and the electrode such that the multi-layer coil conductor has a maximum DC resistance of about 3 to 3.5 ohms and the multi-layer coil conductor further has an impedance when exposed to MRI scans that inhibits induced currents resulting from the MRI scans.

2. The implantable electrical lead of claim 1, wherein the filars of the first coil layer and the second coil layer are individually electrically insulated.

3. The implantable electrical lead of claim 1, wherein the one or more filars of the first and second coil layers are made from drawn filled tube (DFT) wires including a silver core and an outer cladding of a cobalt-nickel-molybdenum alloy.

4. The implantable lead of claim 1, wherein the filars of the first coil layer have a maximum filar thickness of about 0.001 inches, and wherein the filars of the second coil layer have a maximum filar thickness of about 0.003 inches.

5. The implantable electrical lead of claim 1, further comprising a third coil layer disposed about the second coil layer including one or more filars wound in a close pitch and in the same pitch direction as the filars of the first and the second coil layers.

6. The implantable lead of claim 5, wherein the third coil layer has a maximum filar thickness of about 0.004 inches.

7. The implantable electrical lead of claim 6, wherein an inductance of the first coil layer, the second coil layer and the third coil layer are different.

8. The implantable electrical lead of claim 1, wherein the first coil layer and the second coil layer have a 1-filar, 2-filar, 3-filar, or 4-filar construction.

9. The implantable electrical lead of claim 1, wherein the first coil layer has a filar thickness of between, and including, 0.001 inches and 0.002 inches.

10. The implantable electrical lead of claim 1, wherein the first coil layer is formed from a 0.0007 inches drawn filled tube (DFT) wire with a 1 to 4 filar construction and an outside diameter of the first coil layer is less than 0.004 inches.

11. The implantable electrical lead of claim 10, wherein the second coil layer has a filar thickness between, and including, 0.0007 inches to 0.003 inches.

12. An implantable medical lead, comprising:

a flexible body having a proximal region including a proximal end, a distal region, and a longitudinal body lumen extending from the proximal end through the distal region;

a connector assembly configured to mechanically and electrically connect the implantable medical lead to an implantable pulse generator;

an electrode coupled to the flexible body in the distal region; and

a multi-layer coil conductor extending within the longitudinal body lumen, the multi-layer coil conductor comprising a proximal end at the connector assembly and a distal end at the electrode, the multi-layer coil conductor configured to minimize heat rise when exposed to MRI scans, the multi-layer coil conductor including;

an inner coil conductor having an outer diameter (OD), a close pitch, and an inner coil pitch direction of clockwise or counterclockwise;

a middle coil conductor having a close pitch, a middle coil pitch direction the same as the inner coil pitch direction, an inner diameter (ID) greater than the OD of the inner coil conductor, and wherein the middle coil conductor radially surrounds the inner coil conductor along the length of the inner coil conductor from the proximal end to the distal end; and

an outer coil conductor radially surrounding the middle coil conductor from the proximal end to the distal end, the outer coil conductor having a close pitch and an outer coil pitch direction the same as the inner coil pitch direction; and

wherein the inner coil conductor, the middle coil conductor, and the outer coil conductor are electrically coupled to each other in parallel resulting in a DC resistance of approximately 3.5 ohms and an impedance when exposed to an MRI scans that inhibits induced currents resulting from the MRI scans.

13. The implantable medical lead of claim 12, wherein the medical lead further includes one or more layers of insulating material surrounding one or more of the inner coil conductor, the middle coil conductor, or the outer coil conductor.

14. The implantable medical lead of claim 12, wherein the inner coil conductor, the middle coil conductor, or the outer coil conductor have a 1 to 4 filar construction and each having a different pitch.

15. The implantable medical lead of claim 12, wherein the inner coil conductor has a filar thickness of 0.001 inches or less.

16. The implantable medical lead of claim 15, wherein the inner coil conductor is formed from a 0.0007 inches drawn filled tube (DFT) wire with a 1-4 filar assembly and an OD of less than 0.004 inches.

17. The implantable medical lead of claim 16, wherein the outer coil conductor has a wire diameter between, or including, 0.0007 inches to 0.003 inches.

18. The implantable medical lead of claim 12, wherein each of the filars of the inner coil layer, the middle coil layer, and the outer coil layer is individually insulated.

19. An implantable electrical lead, comprising:

a flexible body having a longitudinal body lumen; and

a multi-layer coil conductor extending within the longitudinal body lumen from a connector assembly to at least one electrode, the multi-layer coil conductor configured to minimize heat rise when exposed to MRI scans, the multi-layer coil conductor including a first coil layer including one or more filars, and a second coil layer disposed about the first coil layer including one or more filars,

wherein the first coil layer comprises a first coil layer proximal end and a first coil layer distal end, the second coil layer comprises a second coil layer proximal end and a second coil layer distal end, the first coil layer proximal end is connected to the second coil layer proximal end at or near the connector assembly, and the first coil layer distal end is connected to the second coil layer distal end at or near the at least one electrode such that the first and second coil layers are electrically coupled to one another to provide parallel conductive paths,

wherein the filars of the first coil layer are wound in a first direction from the first coil layer proximal end to the first coil layer distal end, and the filars of the second coil layer are wound in the first direction from the second coil layer proximal end to the second coil layer distal end.