Positioning of a medical device conductor in an MRI environment to reduce RF induced current

• US 9,061,132 B1
• Filed: 02/21/2012
• Issued: 06/23/2015
• Est. Priority Date: 02/18/2011
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Zweber, Jeffrey, Johnson, Robert Shawn
• Primary Examiner(s): Voorhees, Catherine
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US13/400,701
• Time in Patent Office: 1,218 Days
• Field of Search: 607/2, 607/9, 607/115, 607/116, 607/120, 607/121, 607/122
• US Class Current: 1/1
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• 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: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37514 Brain implants
• CPC Class Codes: G01R 33/288 Provisions within MR facilities for enhancing safety during MR, e.g. reduction of the specific absorption rate [SAR], detection of ferromagnetic objects in the scanner room

Abstract

The present invention provides embodiments in which induced RF current heating along the length of a medical lead is reduced. Reduction of induced RF current heating in the medical lead is achieved by positioning a conductor about the exterior of an implantable medical device when the device is placed within an MRI environment. In one embodiment, an RF conductor is incorporated within a header assembly for connecting an implantable medical device to at least one conductor lead. The body of the RF conductor is positioned circumferentially around the implantable medical device. In another embodiment, the medical lead is positioned circumferentially around the exterior of the housing of the medical device. A series of clips or a sleeve holds the medical lead or RF conductor in place around the device.

Claims

1. An implantable medical device, comprising:

a) a housing;

b) a hermetic feedthrough terminal comprising a ferrule supporting an insulative material sealing between at least one conductive lead wire and an inner surface of the ferrule, wherein the ferrule is hermetically sealed in an opening in the housing, and wherein the conductive lead wire extends from a lead wire proximal portion electrically connected to electronic circuits disposed within the device housing remote from the ferrule to a lead wire distal end located outside the housing;

c) an intermediate conductor extending from an intermediate conductor proximal end to an intermediate conductor distal end, wherein the intermediate conductor proximal end is electrically connected to the lead wire distal end and wherein the intermediate conductor distal end is electrically connected to a terminal, the terminal being configured to detachably electrically connect to a lead;

d) an insulative header mounted on the device housing and encasing the intermediate conductor connecting from the lead wire distal end to the terminal;

e) a connector comprising a connector distal portion spaced from a connector proximal portion, the connector distal portion supported by the insulative body and electrically connected to the intermediate conductor second end, the connector proximal portion electrically connected to the at least one feedthrough conductor distal end extending external the housing; and

f) an RF conductor comprising an RF conductor proximal end spaced from an RE conductor distal end, wherein the RE conductor proximal end is electrically connected to the connector with an RE conductor intermediate portion between the proximal and distal ends exiting the insulative header at an exit location and extending along an outer surface of the housing before entering the insulative header at an entry location spaced from the exit location and wherein the RE conductor distal end is electrically connected to the terminal.

2. The implantable medical device of claim 1 wherein the RF conductor is positioned longitudinally around the housing.

3. The implantable medical device of claim 1 wherein the RF conductor is positioned circumferentially around the housing.

4. The implantable medical device of claim 1 wherein the RF conductor is positioned equatorially around the housing.

5. The implantable medical device of claim 1 wherein the RF conductor extends less than one turn around the housing.

6. The implantable medical device of claim 1 wherein the RF conductor extends more than one turn around the housing.

7. The implantable medical device of claim 1 wherein the RF conductor comprises a metallic material.

8. The implantable medical device of claim 7 wherein the metallic material is selected from the group consisting of titanium, platinum, palladium, MP35N, stainless steel, and alloys thereof.

9. The implantable medical device of claim 1 wherein the RF conductor is at least partially insulated.

10. The implantable medical device of claim 1 wherein the RF conductor comprises a wire, a conductive trace, or a filar.

11. The implantable medical device of claim 1 wherein the RF conductor comprises a plurality of wires or filars.

12. The implantable medical device of claim 11 wherein the plurality of wires of filars are arranged in a form comprising a weave, a braid, a cable, a coil, a coaxial coil, a co-radial coil, a wound coil, or a twist.

13. The implantable medical device of claim 1 wherein the RF conductor is positioned within a series of clips that reside on an exterior surface of the housing for the implantable medical device.

14. The implantable medical device of claim 1 wherein the RF conductor is contacted to an exterior surface of the housing for the implantable medical device.

15. The implantable medical device of claim 1 wherein the housing is positioned within an enclosure having a wall thickness, and wherein the RF conductor is positioned within the enclosure wall thickness.

16. The implantable medical device of claim 1 wherein a band having a U-shaped recess is positioned around an exterior surface of the housing for the implantable medical device, and wherein the RF conductor resides within the recess of the band.

17. The implantable medical device of claim 1 wherein the implantable medical device is selected from the group consisting of a hearing assist device, a neurostimulator, a cardiac pacemaker, a drug pump, a cardiac defibrillator, a bone growth stimulator, and an obesity control device.

18. An implantable medical device system, comprising:

a) at least one implantable lead extending from a lead proximal end to a lead distal portion;

b) at least one electrode electrically connected to the lead distal portion, wherein the electrode is configured to be placed in contact with biological cells inside a body;

c) a housing;

d) a control circuitry connected to a power supply residing within the housing;

e) at least one feedthrough conductor having a feedthrough conductor proximal end spaced from a feedthrough conductor distal end, wherein the feedthrough conductor proximal end is positioned within the housing electrically connected to the control circuitry and the feedthrough conductor distal end extends external of the housing;

f) an electrically insulative body mountable on an exterior surface of the housing, wherein the insulative body has at least one inlet that extends within the body from an insulative body exterior surface;

g) a terminal block residing within and supported by the insulative body in open communication with the inlet, the terminal block having a throughbore extending therethrough configured to receive and electrically contact the lead proximal end inserted into the insulative body inlet;

h) an intermediate conductor comprising an intermediate conductor first end connected to the terminal block, and an intermediate conductor second end;

i) a connector comprising a connector distal portion spaced from a connector proximal portion, the connector distal portion supported by the insulative body and electrically connected to the intermediate conductor second end, the connector proximal portion electrically connected to the at least one feedthrough conductor distal end extending external the housing; and

j) wherein with the lead proximal end inserted into the inlet and received in the terminal block throughbore, the lead has sufficient length to extend around at least a portion of an exterior circumference of the housing for the medical device such that RF current through the lead is modified from a first RF current had the lead not been positioned extending around the portion of the exterior circumference to a second RF current that is less than the first RF current.

19. The implantable medical device system of claim 18 wherein the lead is positioned longitudinally about the housing for the implantable medical device.

20. The implantable medical device system of claim 18 wherein the lead is positioned equatorially about the housing for the implantable medical device.

21. The implantable medical device system of claim 18 wherein the lead is positioned circumferentially around the housing for the implantable medical device.

22. The implantable medical device system of claim 18 wherein the lead is positioned such that it completes at least a full circumference of the housing for the implantable medical device.

23. The implantable medical device system of claim 18 wherein the lead completes less than a full circumference about the housing for the implantable medical device.

24. The implantable medical device system of claim 18 wherein the lead is positioned within a series of clips that extend from an exterior surface of the housing.

25. The implantable medical device system of claim 18 wherein the lead is positioned within a sleeve that is supported on an exterior surface of the housing for the implantable medical device.

26. The implantable medical device system of claim 18 wherein the housing is positioned within an enclosure having a wall thickness, and wherein the lead is positioned within the enclosure wall thickness.

27. The implantable medical device system of claim 18 wherein a band having a U-shaped recess is positioned around an exterior surface of the housing, and wherein the lead resides within the recess of the the band.

28. The implantable medical device system of claim 18 wherein the device is selected from the group consisting of a hearing assist device, a neurostimulator, a cardiac pacemaker, a drug pump, a cardiac defibrillator, a bone growth stimulator and an obesity control device.

29. The implantable medical device system of claim 18 wherein the lead is comprised of a plurality of electrically conductive wires or filars.

30. The implantable medical device system of claim 18 wherein the plurality of wires or filars are arranged in a form comprising a cable, a braided, a co-radial, or combination thereof.

31. The implantable medical device system of claim 18 wherein a lead extender connects a distal end of the lead distal portion to a proximal end of a second conductor lead to thereby provide a third lead system having a longer total length than either of the first and second leads.

32. An implantable medical device, comprising:

a) a housing;

b) a control circuitry electrically connected to at least one electrical energy storage device positioned within the housing;

c) an electrically insulative body mounted on an exterior surface of the housing, wherein the electrically insulative body has at least one inlet that extends within the body from an insulative body exterior surface, the insulative body inlet adapted to receive an end of a lead configured to provide therapeutic electrical stimulation to tissue;

d) at least one terminal block that resides within and is supported by the insulative body, wherein the at least one terminal block has a throughbore extending therethrough configured to receive and electrically connect to the lead;

e) at least one feedthrough conductor having a feedthrough conductor distal end spaced from a feedthrough conductor proximal end, the feedthrough conductor proximal end positioned within the housing and electrically connected to the control circuitry that resides within the housing, wherein the feedthrough conductor distal end resides external of the housing;

f) an RF conductor having an RF conductor first end spaced from an RF conductor second end, wherein the RE′

conductor first end is electrically connected to the at least one terminal block positioned within the insulative body and the RF conductor second end is electrically connected to the at least one feedthrough conductor distal end;

wherein when the lead is electrically connected to the terminal block, an RF current within the lead is modified from a first RF current to a second RF current that is less than the first RF current.