MRI-safe high impedance lead systems

• US 8,055,351 B2
• Filed: 10/20/2006
• Issued: 11/08/2011
• Est. Priority Date: 10/21/2005
• 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: Bottomley, Paul, Eldelstein, William, Karmarkar, Parag V., Allen, Justin, Atalar, Ergin
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/090,583
• Publication Number:
  US 20090171421A1
• Time in Patent Office: 1,845 Days
• Field of Search: 607/9, 607/63
• US Class Current: 607/63
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

Some embodiments are directed to MRI/RF compatible medical interventional devices. A plurality of spaced apart high impedance circuit segments are configured to have a high impedance at a high range of radiofrequencies and a low impedance at a low range of frequencies The high impedance circuit segments may comprise co-wound coiled inductors and can reduce, block or inhibit RJ-transmission along the lead system (20) during exposure to RF associated with a high-Held magnet MRI systems, while permuting passage of low frequency physiologic signals, treatments and/or stimuli The devices can include at least one electrode.

Claims

1. An MRI/RF compatible medical device, comprising:

an implantable elongate lead having at least a first electrode, a second electrode, a first axially extending conductor, and a second axially extending conductor, the first electrode electrically coupled to the first axially extending conductor and the second electrode electrically coupled to the second axially extending conductor, wherein, at each of a plurality of intermediate locations along a length of the elongate lead, at least one of a plurality of spaced apart capacitors is disposed between the first and second axially extending conductors to define a plurality of high impedance circuit segments, each high impedance circuit segment comprising at least a portion of the first axially extending conductor, at least a portion of the second axially extending conductor, and at least one of the plurality of spaced apart capacitors disposed between the portion of the first axially extending conductor and the portion of the second axially extending conductor, whereby the lead system has a high impedance at a target range of high radiofrequencies and a low impedance at low frequencies.

2. A device according to claim 1, wherein the high impedance circuit segments are configured to reduce or eliminate electronic coupling of the lead system to external RF.

3. A device according to claim 2, wherein the lead system comprises three axially spaced apart electrodes and a respective first, second and third conductor, and wherein some of the capacitors are arranged to extend between the first and second conductors and others are arranged to extend between the second and third conductors.

4. A device according to claim 3, wherein the capacitors between the first and second conductors are axially offset from the capacitors between the first and third conductors.

5. A device according to claim 1, wherein the high impedance circuit segments are configured to reduce or eliminate transmission of induced RF along the length of the lead system.

6. A device according to claim 1, wherein at least one of the first and second conductors defines an inductor that is in electrical communication with at least two of the capacitors.

7. A device according to claim 1, wherein the spaced apart capacitors are substantially regularly spaced apart axially.

8. A device according to claim 1, wherein at least some of the spaced apart capacitors are axially spaced apart at irregular intervals from the others over the length of the lead system.

9. A device according to claim 1, wherein the components of the lead system are formed from non-magnetic materials.

10. A device according to claim 1, wherein the high impedance circuit segments are configured to inhibit RF transmission along the lead system during exposure to RF associated with a high-field magnet MRI system.

11. A device according to claim 10, wherein the high impedance circuit segments include at least one inductor distributed along at least a major portion of a length of at least one of the conductors.

12. A device according to claim 11, wherein the at least one inductor comprises a coil inductor defined by a wound coil segment of the at least one conductor.

13. A device according to claim 12, wherein the coil inductor is wound to encase other conductors of the lead system.

14. A device according to claim 12, wherein the coil inductor is substantially an entire length of the at least the first conductor, and wherein the spaced capacitors connect segments of the coil and the second conductor.

15. A device according to claim 11, wherein the first and second conductors have a respective length, and wherein portions of the length of the first and second conductors disposed axially between the spaced apart capacitors comprise inductors.

16. A device according to claim 11, wherein the values of the capacitances and at least one inductance associated with the lead system define a high impedance over the RF range of between about 1-150 MHz and a low impedance at frequencies less than about 50 kHz.

17. A device according to claim 1, further comprising an electrically insulating biocompatible coating disposed over an external surface of the lead system.

18. An MRI compatible device/lead system, comprising:

an implantable lead system elongate lead having at least a first and a second electrode, each associated with a respective first and second axially extending conductor; and

a high impedance surface band gap structure disposed about the first and second conductors, wherein the surface band gap structure comprises a primary shield and secondary and tertiary segmented shields which are intermittently connected to the primary shield, whereby the high impedance surface reduces or blocks RF propagation.

19. An MRI compatible device comprising:

an implantable lead system elongate lead having at least a first and a second electrode, each associated with a respective first and second axially extending conductor, wherein a plurality of spaced apart capacitors are disposed between the first and second axially extending conductors along at least major portion of a length of the lead system to define a plurality of high impedance circuit segments; and

a high impedance surface band gap structure formed along at least a major length of the lead system, wherein the surface band gap structure comprises a primary shield and secondary and tertiary segmented shields which are intermittently connected to the primary shield, whereby the high impedance surface reduces or blocks RF propagation;

wherein the lead system has a high impedance at a high range of radiofrequencies and a low impedance at a low range of frequencies.

20. An MRI compatible implantable pulse generator (IPG), comprising:

an implantable housing;

a high impedance decoupling circuit disposed in the housing;

at least one implantable lead in communication with the decoupling circuit and configured with a length that extends from the housing to a target treatment site;

at least one implantable electrode in communication with the lead; and

a controller in the implantable housing, the controller configured to selectively activate the decoupling circuit to provide a high impedance to the lead at high radiofrequencies and a low impedance at a low radiofrequencies, wherein the controller is remotely controllable to activate the decoupling circuit to provide the high impedance.

21. An MRI safe lead system, comprising:

an elongate flexible body with a plurality of conductive leads, the body having distal and proximal portions, the conductive leads having a plurality of axially spaced apart coiled segments and a plurality of linear segments residing between adjacent coiled segments;

at least one electrode in communication with the at least one conductive lead; and

a plurality of high impedance segments axially spaced apart along a length of the conductive lead, the high impedance segments including;

a coiled conductive lead segment defining an inductor;

a dielectric over the coiled conductive lead segment;

a conductive shield over the dielectric with the dielectric residing between the inductor and the conductive shield; and

a plurality of capacitors at a first end portion of the coiled lead segment, a respective capacitor electrically connecting a respective conductive lead to the shield to define an RF short and low frequency open circuit,

wherein the high impedance segments are tuned to a target RF frequency associated with an MRI system.

22. A lead system according to claim 21, wherein each conductive lead is electrically coupled to the conductive shield at the opposing end portion of the respective coiled segments via a tuning capacitor.

23. An MRI safe lead system, comprising:

an elongate flexible body with at least one conductive lead, the body having distal and proximal portions, the at least one conductive lead having a plurality of axially spaced apart coiled segments and a plurality of linear segments residing between adjacent coiled segments;

at least one electrode in communication with the at least one conductive lead; and

a plurality of high impedance segments axially spaced apart along a length of the lead, the high impedance segments including;

a coiled conductive lead segment defining an inductor;

a dielectric over the coiled conductive lead segment;

a conductive shield over the dielectric with the dielectric residing between the inductor and the conductive shield, wherein the at least one conductive lead is electrically coupled to the shield at a first end portion of the coiled segment; and

a capacitor at an opposing second end portion of the coiled conductive lead segment electrically connecting the at least one conductor and the shield to define an RF short and low frequency open circuit,

wherein the high impedance segments are tuned to a target RF frequency associated with an MRI system.

24. A lead system according to claim 23, wherein the at least one conductive lead is a plurality of conductive leads, each having a plurality of axially spaced apart coiled segments, wherein each conductive lead is electrically coupled to the conductive shield at the second end portion via a respective tuning capacitor.

25. A lead system according to claim 23, wherein the coiled conductive lead segments have a length between about 0.1-200 cm, wherein at least some of the coiled conductive lead segments comprise coiled segments that are co-wound with other conductive leads, and wherein the conductive shield is flexible.

26. An MRI safe lead system, comprising:

an elongate flexible body with a plurality of conductive leads, the conductive leads each having a plurality of axially spaced apart coiled segments defining an inductor;

at least one electrode residing at a distal portion of the flexible body in communication with at least one of the conductive leads; and

a plurality of high impedance segments axially spaced apart along a length of the flexible body, the high impedance segments each having a length with opposing proximal and distal end portions, the high impedance segments including;

a plurality of coiled conductive lead segments residing at a common axially extending segment of the flexible body, at least one coiled conductive lead segment for each of the leads;

a dielectric insulator covering the plurality of coiled conductive lead segments at the common axial segment;

a conductive shield at the common axial segment disposed over the dielectric insulator with the dielectric insulator residing between the coiled conductive lead segments and the conductive shield,

wherein a single one of the plurality of conductive leads is electrically coupled to the conductive shield at one of the end portions of the high impedance segment proximate the common axial segment, and

wherein the high impedance segments are tuned to at least one MRI operating frequency.

27. An MRI safe lead system according to claim 26, wherein the plurality of coiled segments are co-wound to each start and end at substantially the same locations at the common axially extending segment.

28. An MRI safe lead system according to claim 26, wherein the single one of the plurality of conductive leads is connected to the conductive shield via a capacitor configured to generate an RF short and low frequency open circuit.

29. An MRI safe lead system according to claim 26, wherein the high impedance segments are configured so that a different one of the conductive leads is connected to the conductive shield at different high impedance segments along a length of the lead system, and wherein the lead system has at least the same number of high impedance segments as the number of conductive leads, and wherein each of the conductive leads is connected to the shield at least once over the length of the lead system.

30. An MRI safe lead system, comprising:

an elongate flexible body with a plurality of conductive leads and at least one high impedance segment with opposing proximal and distal portions, wherein the at least one high impedance segment is configured so that;

at least one of the conductive leads has (a) a first individually coiled segment that is proximate to but axially apart from the coiled segments of the other conductive leads, and (b) a second coiled segment that is co-wound with at least one of coiled segment of another conductive lead;

a conductive shield residing over the first and second coiled conductive lead segments; and

an insulating material residing between the shield and the first and second coiled conductive lead segments,

wherein the at least one conductive lead with the individual and co-wound coiled conductive lead segments is in electrical communication with the shield at a first end portion of the high impedance segment, and

wherein the high impedance segments are tuned to at least one MRI operating frequency.

31. An MRI safe lead system according to claim 30, wherein the high impedance segment defines a parallel resonant circuit that is tuned to a plurality of high frequencies, including at least one MRI operating frequency.

32. An MRI safe lead system according to claim 31, wherein the high impedance segment resonant circuit is tuned to at least two different frequencies associated with different magnetic field strength MRI scanners.

33. An MRI safe lead system according to claim 30, further comprising a plurality of capacitors, at least one capacitor being in electrical communication with a respective one of the conductive leads and the shield at a second end portion opposing the first end portion of the high impedance segment to define an RF short and a low frequency open circuit.

34. An MRI safe lead system according to claim 30, wherein the conductive leads each have a substantially straight section at the proximal portion of the high impedance segment, the straight section merging into the coiled segment.

35. An MRI safe lead system according to claim 30, wherein the plurality of leads is at least three leads, and wherein the at least one high impedance segment is configured so that each of the conductive leads has an individual coiled segment that merges into a common co-wound segment or a common co-wound segment that merges into an individually coiled segment, with all of the conductive leads being co-wound for an axial length in the high impedance segment.

36. An MRI safe lead system according to claim 35, wherein the common axially co-wound length is between about 0.1 cm to about 50 cm.

37. An MRI safe lead system according to claim 30, wherein each of the conductive leads is in electrical communication with the shield at the proximal portion of the high impedance segment via a respective capacitor to define an RF short and low frequency open circuit.

38. An MRI safe lead system according to claim 30, further comprising at least one electrode on a distal portion of the flexible body.

39. An MRI safe lead system according to claim 30, wherein the conductive leads are in electrical communication with the shield at the distal portion of the high impedance segment via a tuning capacitor.