Systems and methods for improving RF compatibility of electrical stimulation leads

• US 9,604,066 B2
• Filed: 05/16/2013
• Issued: 03/28/2017
• Est. Priority Date: 05/18/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carbunaru, Rafael, McDonald, Matthew Lee
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/896,109
• Publication Number:
  US 20130310900A1
• Time in Patent Office: 1,412 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

An implantable lead assembly for an electrical stimulation system includes a first lead configured for insertion into a patient. A current-limiting arrangement is coupleable with the first lead. The current-limiting arrangement is configured for limiting the amount of RF-induced current propagating along a body of the first lead during an MRI procedure. The current-liming arrangement includes a safety device configured to couple to the lead body when the lead body is implanted in the patient. The safety device defines a first port extending along a length of the safety device. The first port is configured for receiving a proximal end portion of the lead body and covering each of multiple terminals disposed along the lead body to prevent the terminals from contacting patient tissue. The safety device provides an impedance of at least 50 ohms at one or more MRI RF frequencies.

Claims

1. An implantable lead assembly for an electrical stimulation system, the lead assembly comprising:

a first lead configured and arranged for insertion into a patient, the first lead comprising

a lead body having a distal end portion, a proximal end portion, and a longitudinal length,

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

a plurality of terminals disposed along the proximal end portion of the lead body, and

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals; and

a current-limiting arrangement coupleable with the first lead, the current-limiting arrangement configured and arranged for limiting the amount of RF-induced current propagating along the lead body during an MRI procedure, the current-liming arrangement comprising

a safety device configured and arranged to couple to the lead body when the lead body is implanted in the patient, the safety device having a length and an outer surface, the safety device defining a first port extending along the length of the safety device, the first port configured and arranged for receiving the proximal end portion of the lead body and for covering each of the plurality of terminals to prevent the plurality of terminals from contacting patient tissue, wherein the safety device provides an impedance of at least 50 ohms at one or more MRI RF frequencies, and

a monitoring device coupleable to the safety device and comprising an alarm configured and arranged for activating when the monitoring device detects a potentially unsafe condition being experienced by the safety device.

2. The lead assembly of claim 1, wherein the safety device is configured and arranged for disposing entirely within the patient when the safety device is coupled to the lead body.

3. The lead assembly of claim 1, wherein the safety device comprises at least one filter.

4. The lead assembly of claim 1, further comprising a second lead.

5. The lead assembly of claim 1, wherein at least a portion of the outer surface of the safety device comprises a conductive material.

6. The lead assembly of claim 1, wherein at least a portion of the outer surface of the safety device comprises a non-conductive material.

7. An electrical stimulating system comprising:

the lead assembly of claim 1;

a control module configured and arranged to electrically couple to the lead body of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

at least one connector configured and arranged for receiving the lead body, the at least one connector having a first end and an opposing second end, the at least one connector comprising

a connector housing defining a port at the first end of the connector, the port configured and arranged for receiving the proximal end portion of the lead body, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals of the lead body when the lead body is inserted into the port of the connector housing.

8. The electrical stimulation system of claim 7, wherein the control module comprises the connector, the electrical stimulation system further comprising a plug configured and arranged for insertion into the port of the connector.

9. The implantable lead assembly of claim 1,

wherein the safety device is configured and arranged to at least partially extend externally from the patient when the safety device is coupled to the lead body.

10. The lead assembly of claim 1, wherein the current-limiting arrangement further comprises at least one cable configured and arranged for coupling the safety device to the monitoring device.

11. The lead assembly of claim 1, wherein the monitoring device is configured and arranged to monitor attachment of the safety device to the first lead.

12. The lead assembly of claim 1, wherein the monitoring device is configured and arranged to monitor at least one condition experienced by the safety device, the at least one condition comprising at least one of RF current, gradient current, temperature, vibration, or acceleration.

13. The lead assembly of claim 1, wherein the monitoring device is configured and arranged to monitor at least one patient parameter, the at least one patient parameter comprising at least one of pulse, blood pressure, heart rhythm;

heart rate, breathing rate, or temperature of the patient.

14. The lead assembly of claim 1, wherein the alarm is configured and arranged for activating when the monitoring device detects at least one patient parameter outside of a predetermined range.

15. The lead assembly of claim 1, wherein the unsafe condition that activates the alarm includes excessive RF current;

excessive gradient current;

or excessive thermal increase.

16. The lead assembly of claim 4, wherein the safety device further defines a second port configured and arranged receiving a portion of the second lead.

17. The lead assembly of claim 10, wherein the safety device comprises a connector configured and arranged to receive a portion of the at least one cable.

18. The lead assembly of claim 1, where the alarm is configured and arranged for activating when the monitoring device detects the potentially unsafe condition being experienced by the safety device, wherein the potentially unsafe condition is at least one of an RF current, a gradient current, a thermal increase, vibration, acceleration, or movement that, when detected, is determined to exceed a threshold level.

19. A method for protecting a patient with an implanted medical device from current propagation along the medical device during exposure to applied electromagnetic fields during an MRI procedure using the lead assembly of claim 1, the method comprising:

inserting the first lead into a patient;

coupling the safety device of the current-limiting arrangement to the lead body;

performing an MRI procedure on the patient while the safety device is coupled to the lead body of the first lead; and

removing the safety device from the lead body within three months of coupling the safety device to the lead body.

20. The method of claim 19, further comprising uncoupling the proximal end portion of the lead body from an implanted control module prior to coupling the safety device to the lead body.