Implantable lead bandstop filter employing an inductive coil with parasitic capacitance to enhance MRI compatibility of active medical devices

• US 8,903,505 B2
• Filed: 10/19/2011
• Issued: 12/02/2014
• Est. Priority Date: 06/08/2006
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A., Halperin, Henry R., Lardo, Albert C., Dabney, Warren S., Kondabatni, Kishore Kumar, Frysz, Christine A., Johnson, Robert Shawn, Moschiano, Holly Noelle, Muffoletto, Barry C.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US13/276,484
• Publication Number:
  US 20120071956A1
• Time in Patent Office: 1,140 Days
• Field of Search: 607/2, 607/9, 600/411, 600/424
• US Class Current: 607/116
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2090/374 NMR or MRI
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: H03H 1/0007 of radio frequency interference filters
• CPC Class Codes: H03H 2001/0042 Wound, ring or feed-through type capacitor
• CPC Class Codes: H03H 2001/005 Wound, ring or feed-through type inductor
• CPC Class Codes: H03H 2007/013 Notch or bandstop filters
• CPC Class Codes: H03H 7/1766 Parallel LC in series path H03H7/1783 takes precedence

Abstract

A medical lead system includes at least one bandstop filter for attenuating current flow through the lead across a range of frequencies. The bandstop filter has an overall circuit Q wherein the resultant 3 dB bandwidth is at least 10 kHz. The values of capacitance and inductance of the bandstop filter are selected such that the bandstop filter is resonant at a selected center frequency or range of frequencies. Preferably, the bandstop filter has an overall circuit Q wherein the resultant 10 dB bandwidth is at least 10 kHz. Such bandstop filters are backwards compatible with known implantable deployment systems and extraction systems.

Claims

1. An implantable medical lead, comprising:

a) an implantable lead conductor extending from a proximal conductor end to a distal conductor portion having a distal conductor end, wherein the proximal conductor end is electrically connectable to an active implantable medical device;

b) a mandrel comprising an intermediate mandrel body extending from a proximal mandrel end cap to a distal mandrel end cap, wherein the proximal and distal mandrel ends are electrically conductive;

c) a self-resonant inductor comprising at least a portion of the lead conductor formed as a coiled inductor contacted with a dielectric material, wherein the coiled inductor contacted with the dielectric material is wrapped around the mandrel body from adjacent to the proximal mandrel end cap to adjacent to the distal mandrel end cap;

d) at least one electrode electrically connected to the distal conductor portion or the distal conductor end, wherein the electrode is contactable with biological cells; and

e) an insulation material extending from at least a first outer surface of the proximal mandrel end cap to a second outer surface of the distal mandrel end cap and covering at least an outer surface of the dielectric material contacting the coiled inductor to thereby prevent RF currents in body fluids and tissues from flowing from and to the proximal and distal mandrel ends by isolating both ends of the self-resonant inductor, which currents would otherwise degrade an impedance at resonance of the self-resonant inductor,

f) wherein the self-resonant inductor has a parasitic capacitance between adjacent turns of the coiled inductor to thereby provide an equivalent circuit comprising an inductance in parallel with the parasitic capacitance,

g) wherein the parasitic capacitance provides a capacitive series resistance (R_C) and the self-resonant inductor has an inductance and an inductor series resistance (R_L), wherein at low frequencies of about 10 Hz to about 1 kHz an inductive reactance and the inductor series resistance (R_L) permit passage of biological signals from the electrode to the proximal lead conductor end while a capacitive reactance and the capacitive series resistance (R_C) substantially act as an open circuit to the same biological signals that the self-resonant inductor allows to pass,

h) wherein the self-resonant inductor is resonant at or near an RF frequency, thereby providing a high impedance in series with the lead conductor at or near the RF frequency, and

i) wherein the self-resonant inductor has an overall circuit Q so that the resultant 3-dB bandwidth is at least 100 kHz.

2. The lead of claim 1 wherein the resultant 3-dB bandwidth is on the order of megahertz and at least 0.5 MHz.

3. The lead of claim 1 wherein the resultant 3-dB bandwidth is on the order of MHz and is at least 10 MHz.

4. The lead of claim 1 wherein each of the dielectric material and the insulation material is selected from the group consisting of polyimide, aromatic polyimide, liquid crystal polymer, PTFE, PEEK, ETFE, Parylene, tantalum oxides, iridium oxides, niobium oxides, hafnium oxides, ruthenium oxides, SiO₂, Si₃N₄, Al₂O₃, Y₂O₃, La₂O₃, Ta₂O₅, TiO₂, HfO₂, ZrO₂, PFA, FEP, Polyurethane, polyamide, polyvinyl acetal, polyvinyl acetal overcoated with polyamide, polyurethane overcoated with polyamide, epoxy, polyester (amide) (imide) overcoated with polyamide, polyester (amide) (imide), silicone-treated glass fiber, polyamide-imide, polyvinylchloride (PVC), polylefin class:

{LDPE, HDPE, TPO, TPR, polyolefin alloys}, LDPE low density, HDPE high density, polypropylene (PP), thermoplastic fluoropolymers, TEFLON FEP, Tefzel ETFE, Kynar PVDF, TEFLON PEA, Halar ECTFE, XLPE, XLPVC, silicone rubber, Polyimide Kapton film, Polyester Mylar film, Kaladex PEN film, and a crosslinked polyalkene.

5. The lead of claim 1 wherein each of the dielectric material and the insulation material has a dielectric constant greater than 1 up to 100.

6. The lead of claim 1, wherein a Q_i of the self-resonant inductor is relatively high and a Q_c of the capacitance is relatively low.

7. The lead of claim 1, wherein a Q_i of the self-resonant inductor is relatively low and a Q_c of the capacitance is relatively high.

8. The lead of claim 1, wherein the Q of the self-resonant inductor results in a 3-dB bandwidth that spans a plurality of MRI RF pulsed frequencies.

9. The lead of claim 1 wherein the self-resonant inductor is disposed at, adjacent to, or within the electrode.

10. The lead of claim 1, wherein the self-resonant inductor is integrated into the electrode comprising either a pacemaker Tip electrode or a pacemaker Ring electrode.

11. The lead of claim 1, wherein the self-resonant inductor is at least partially housed within a heat dissipating shield.

12. The lead of claim 1, wherein at least one of the dielectric material and the insulation material is provided with a thermally conductive material.

13. The lead of claim 1, wherein the proximal and distal mandrel ends are provided as conductive end caps.

14. The lead of claim 1, wherein a shape of the lead conductor comprising the coiled inductor is of a rectangular or square cross-sectional configuration.

15. The lead of claim 1, wherein the self-resonant inductor resonates at a center frequency and at one or more of its harmonic frequencies.

16. The lead of claim 1 wherein the insulation material is contiguous with an insulation of the implantable lead conductor.

17. The lead of claim 1 wherein the insulation material comprises an insulative sleeve disposed about the coiled inductor portion of the implantable lead conductor.

18. The lead of claim 1, wherein the coiled inductor portion of the lead conductor includes distinct segments having different numbers of turns contacted with a respective dielectric material to form distinct self-resonant inductors which resonate at different center frequencies or across different ranges of frequencies.

19. The lead of claim 1 wherein the intermediate mandrel body has a first diameter that is less than second and third diameters of the respective proximal and distal ends to thereby provide the mandrel having first and second steps formed from a third outer surface of the intermediate body to the first and second outer surfaces of the respective proximal and distal ends and wherein the insulation material substantially covers the first and second outer surfaces of the proximal and distal ends with the coiled inductor comprising the self-resonant inductor residing in a recess of the mandrel provided by the first and second steps.

20. The lead of claim 1 wherein the mandrel has a hollow lumen extending from the proximal mandrel end cap to the distal mandrel end cap.

21. An implantable lead, comprising:

a) an implantable conductor extending from a proximal conductor end to a distal conductor portion having a distal conductor end, wherein the proximal conductor end is electrically connectable to an active implantable medical device;

b) a mandrel comprising an intermediate mandrel body extending from a proximal mandrel end cap to a distal mandrel end cap, wherein the proximal and distal mandrel ends are electrically conductive;

c) a self-resonant inductor comprising at least a portion of the lead conductor formed as a coiled inductor contacted with a dielectric material, wherein the coiled inductor contacted with the dielectric material is wrapped around the mandrel body from adjacent to the proximal mandrel end cap to adjacent to the distal mandrel end cap;

d) at least one electrode electrically connected to the distal conductor portion or the distal conductor end, wherein the electrode is contactable with biological cells; and

e) an insulation material extending from at least a first outer surface of the proximal mandrel end cap to a second outer surface of the distal mandrel end cap and covering at least an outer surface of the dielectric material contacting the coiled inductor to thereby prevent RF currents in body fluids and tissues from flowing from and to the proximal and distal mandrel ends by isolating both ends of the self-resonant inductor, which currents would otherwise degrade an impedance at resonance of the self-resonant inductor,

f) wherein the self-resonant inductor has a parasitic capacitance between adjacent turns of the coiled inductor to thereby provide an equivalent circuit comprising an inductance in parallel with the parasitic capacitance,

g) wherein the parasitic capacitance provides a capacitive series resistance (R_C) and the self-resonant inductor has an inductance and an inductor series resistance (R_L), wherein at low frequencies of about 10 Hz to about 1 kHz an inductor reactance and the inductor series resistance (R_L) permit passage of biological signals from the electrode to the proximal lead conductor end while a capacitive reactance and the capacitive series resistance (R_C) substantially act as an open circuit to the same biological signals that the self-resonant inductor allows to pass,

h) wherein the self-resonant inductor is resonant at or near an RF frequency, thereby providing a high impedance in series with the lead conductor at or near the RF frequency, and

i) wherein the self-resonant inductor has an overall circuit Q, wherein the resultant 3-dB bandwidth is at least 10 kHz and the resultant 10-dB bandwidth is at least 25 kHz.

22. The lead of claim 21 wherein the 3-dB bandwidth is on the order of megahertz and at least 0.5 MHz.

23. The lead of claim 21 wherein the 10-dB bandwidth is on the order of MHz and at least 0.5 MHz.

24. The lead of claim 21 wherein each of the dielectric material and the insulation material is selected from the group consisting of polyimide, aromatic polyimide, liquid crystal polymer, PTFE, PEEK, ETFE, Parylene, tantalum oxides, iridium oxides, niobium oxides, hafnium oxides, ruthenium oxides, SiO₂, Si₃N₄, Al₂O₃, Y₂O₃, La₂O₃, Ta₂O₅, TiO₂, HfO₂, ZrO₂, PFA, FEP, Polyurethane, polyamide, polyvinyl acetal, polyvinyl acetal overcoated with polyamide, polyurethane overcoated with polyamide, epoxy, polyester (amide) imide) overcoated with polyamide, polyester (amide) (imide), silicone-treated glass fiber, polyamide-imide, polyvinylchloride (PVC), polylefin class:

{LDPE, HDPE, TPO, TPR, polyolefin alloys}, LDPE low density, HDPE high density, polypropylene (PP), thermoplastic fluoropolymers, TEFLON FEP, Tefzel ETFE, Kynar PVDF, TEFLON PEA, Halar ECTFE, XLPE, XLPVC, silicone rubber, Polyimide Kapton film, Polyester Mylar film, Kaladex PEN film, and a crosslinked polyalkene.

25. The lead of claim 21 wherein the Q of the self-resonant inductor results in a 3-dB bandwidth that spans a plurality of MRI RE pulsed frequencies.

26. The lead of claim 21 wherein the self-resonant inductor is at least partially housed within a heat dissipating shield.

27. The lead of claim 21 wherein the insulation material is a thermally conductive material.

28. The lead of claim 21 wherein a shape of the lead conductor comprising the coiled inductor is of a rectangular or square cross-sectional configuration.

29. The lead of claim 21 wherein the self-resonant inductor resonates at a center frequency and at one or more of its harmonic frequencies.

30. The lead of claim 21 wherein the coiled inductor portion of the lead conductor includes distinct segments having different numbers of turns contacted with a respective dielectric material to form distinct self-resonant inductors which resonate at different center frequencies or across different ranges of frequencies.

31. The lead of claim 21 wherein each of the dielectric material and the insulation material has a dielectric constant greater than 1 up to 100.

32. The lead of claim 21 wherein the intermediate mandrel body has a first diameter that is less than second and third diameters of the respective proximal and distal ends to thereby provide the mandrel having first and second steps formed from a third outer surface of the intermediate body to the first and second outer surfaces of the respective proximal and distal ends and wherein the insulation material substantially covers the first and second outer surfaces of the proximal and distal ends with the coiled inductor comprising the self-resonant inductor residing in a recess of the mandrel provided by the first and second steps.

33. The lead of claim 21 wherein the mandrel has a hollow lumen extending from the proximal mandrel end cap to the distal mandrel end cap.

34. An implantable medical lead, comprising:

a) an implantable lead conductor extending from a proximal conductor end to a distal conductor portion having a distal conductor end, wherein the proximal conductor end is electrically connectable to an active implantable medical device;

b) a mandrel comprising an intermediate mandrel body extending from a proximal mandrel end cap to a distal mandrel end cap, wherein the proximal and distal mandrel ends are electrically conductive;

c) a self-resonant inductor comprising at least a portion of the lead conductor formed as a coiled inductor contacted with a dielectric material, wherein the coiled inductor contacted with the dielectric material is wrapped around the mandrel body from adjacent to the proximal mandrel end cap to adjacent to the distal mandrel end cap;

d) at least one electrode electrically connected to the distal conductor portion or the distal conductor end, wherein the electrode is contactable with biological cells;

e) an insulation material extending from at least a first outer surface of the proximal mandrel end cap to a second outer surface of the distal mandrel end cap and covering at least an outer surface of the dielectric material contacting the coiled inductor to thereby prevent RF currents in body fluids and tissues from flowing from and to the proximal and distal mandrel ends by isolating both ends of the self-resonant inductor, which currents would otherwise degrade an impedance at resonance of the self-resonant inductor,

f) wherein the self-resonant inductor has a parasitic capacitance between adjacent turns of the coiled inductor to thereby provide an equivalent circuit comprising an inductance in parallel with the parasitic capacitance,

g) wherein the parasitic capacitance provides a capacitive series resistance (R_C) and the self-resonant inductor has an inductance and an inductor series resistance (R_L), wherein at low frequencies of about 10 Hz to about 1 kHz an inductor reactance and the inductor series resistance (R_L) permit passage of biological signals from the electrode to the proximal lead conductor end while a capacitive reactance and the capacitive series resistance (R_C) substantially act as an open circuit to the same biological signals that the self-resonant inductor allows to pass,

h) wherein the self-resonant inductor is resonant at or near an RF frequency, thereby providing a high impedance in series with the lead conductor at or near the RF frequency, and

i) wherein the self-resonant inductor has an overall circuit Q so that the resultant 3-dB bandwidth is at least 0.5 MHz and the 10-dB bandwidth is at least 0.5 MHz.

35. The lead of claim 34 wherein each of the dielectric material and the insulation material has a dielectric constant greater than 1 up to 100.

36. The lead of claim 34 wherein the Q of the self-resonant inductor resulting in a 3-dB bandwidth that spans a plurality of MRI RF pulsed frequencies.

37. The lead of claim 34 wherein a shape of the lead conductor comprising the coiled inductor is of a rectangular or square cross-sectional configuration.

38. The lead of claim 34 wherein the self-resonant inductor resonates at a center frequency and at one or more of its harmonic frequencies.

39. The lead of claim 34 wherein the coiled inductor portion of the lead conductor includes distinct segments having different numbers of turns contacted with a respective dielectric material to form distinct self-resonant inductors which resonate at different center frequencies or across different ranges of frequencies.

40. The lead of claim 34 wherein the self-resonant inductor is at least partially housed within a heat dissipating shield.

41. The lead of claim 34 wherein each of the dielectric material and the insulation material has a dielectric constant greater than 1 up to 100.

42. The lead of claim 34 wherein the intermediate mandrel body has a first diameter that is less than second and third diameters of the respective proximal and distal ends to thereby provide the mandrel having first and second steps formed from a third outer surface of the intermediate body to the first and second outer surfaces of the respective proximal and distal ends and wherein the insulation material substantially covers the first and second outer surfaces of the proximal and distal ends with the coiled inductor comprising the self-resonant inductor residing in a recess of the mandrel provided by the first and second steps.

43. The lead of claim 34 wherein the mandrel has a hollow lumen extending from the proximal mandrel end cap to the distal mandrel end cap.

44. An implantable lead, probe or catheter, comprising:

a) a conductor extending from a proximal conductor end to a distal conductor portion having a distal conductor end;

b) a mandrel comprising an intermediate mandrel body extending from a proximal mandrel end cap to a distal mandrel end cap, wherein the proximal and distal mandrel ends are electrically conductive;

c) a self-resonant inductor comprising at least a portion of the lead conductor formed as a coiled inductor contacted with a dielectric material, wherein the coiled inductor contacted with the dielectric material is wrapped around the mandrel body from adjacent to the proximal mandrel end cap to adjacent to the distal mandrel end cap;

d) at least one electrode electrically connected to the lead conductor at the distal conductor portion or the distal conductor end, wherein the electrode is configured for placement in contact with biological cells; and

d) an insulation material extending from at least a first outer surface of the proximal mandrel end cap to a second outer surface of the distal mandrel end cap and covering at least an outer surface of the dielectric material contacting the coiled inductor to thereby prevent RF currents in body fluids and tissues from flowing from and to the proximal and distal mandrel ends by isolating both ends of the self-resonant inductor, which currents would otherwise degrade an impedance at resonance of the self-resonant inductor,

e) wherein the self-resonant inductor has a parasitic capacitance between adjacent turns of the coiled inductor to thereby provide an equivalent circuit comprising an inductance in parallel with the parasitic capacitance,

f) wherein the parasitic capacitance provides a capacitive series resistance (R_C) and the self-resonant inductor has an inductance and an inductor series resistance (R_L), wherein at low frequencies of about 10 Hz to about 1 kHz an inductor reactance and the inductor series resistance (R_L) permit passage of biological signals from the electrode to the proximal lead conductor end while a capacitive reactance and the capacitive series resistance (R_C) substantially act as an open circuit to the same biological signals that the self-resonant inductor allows to pass,

g) wherein the self-resonant inductor is resonant at or near an RF frequency, thereby providing a high impedance in series with the lead conductor at or near the RF frequency, and

h) wherein the self-resonant inductor has an overall circuit Q so that the resultant 3-dB bandwidth is at least 100 kHz.

45. The lead of claim 44 wherein the intermediate mandrel body has a first diameter that is less than second and third diameters of the respective proximal and distal ends to thereby provide the mandrel, having first and second steps formed from a third outer surface of the intermediate body to the first and second outer surfaces of the respective proximal and distal ends and wherein the insulation material substantially covers the first and second outer surfaces of the proximal and distal ends with the coiled inductor comprising the self-resonant inductor residing in a recess of the mandrel provided by the first and second steps.

46. The lead of claim 44 wherein the mandrel has a hollow lumen extending from the proximal mandrel end cap to the distal mandrel end cap.