Implantable medical leads, systems, and related methods for creating a high impedance within a conduction path in the presence of a magnetic field of a given strength

• US 9,579,502 B2
• Filed: 04/13/2015
• Issued: 02/28/2017
• Est. Priority Date: 04/19/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stone, Richard T., Bondhus, Spencer M., Doell, Walter, Welter, John D., Schmit, Guillaume, Schneeberger, Niklaus
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/684,628
• Publication Number:
  US 20150297886A1
• Time in Patent Office: 687 Days
• Field of Search: 607/63
• US Class Current: 1/1
• 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 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: H01F 41/0206 Manufacturing of magnetic cores by mechanical means magnetic cores per se H01F27/24
• CPC Class Codes: H01F 41/0233 Manufacturing of magnetic circuits made from sheets magnetic cores made from sheets H01F27/245; soft magnetic alloys in the form of sheets H01F1/16
• CPC Class Codes: H01F 41/0253 for manufacturing permanent magnets
• CPC Class Codes: H01F 41/0286 Trimming
• CPC Class Codes: H01H 2036/0093 Micromechanical switches actuated by a change of the magnetic field
• CPC Class Codes: H01H 2229/00 Manufacturing
• CPC Class Codes: H01H 36/008 Change of magnetic field wherein the magnet and switch are fixed, e.g. by shielding or relative movements of armature for reed switches H01H36/002
• CPC Class Codes: H01H 49/00 Apparatus or processes specially adapted to the manufacture of relays or parts thereof

Abstract

Implantable medical systems include implantable medical leads that have magnetic orientation-independent magnetically actuated switches that are placed in the conduction path to the electrode of the lead. Thus, regardless of the orientation of a substantial magnetic field like that from an MRI machine to the lead and switch within the lead, the switch opens when in the presence of that substantial magnetic field. The switch may be placed in close proximity to the electrode such that the opening of the switch disconnects the electrode from the majority of the conduction path which thereby produces a high impedance for RF current and reduces the amount of heating that may occur at the electrode when in the presence of substantial levels of RF electromagnetic energy as may occur within an MRI machine.

Claims

1. A method of creating a high impedance within a conduction path of an implantable medical lead, comprising:

providing a first magnetically responsive actuator that when in a presence of a magnetic field of an MRI scanner moves from a first start position toward a first stop position and reaches the first stop position when the magnetic field is not oriented normal to a direction of movement of the first actuator;

providing a second magnetically responsive actuator that when in the presence of the magnetic field moves from a second start position toward a second stop position and reaches the second stop position when the magnetic field is not oriented parallel to a direction of movement of the second actuator; and

providing at least one switch in series with the conduction path, the at least one switch being coupled to both the first actuator and the second actuator, wherein the at least one switch resides in a closed state and achieves an open state to create the high impedance when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

2. The method of claim 1, wherein providing at least one switch comprises providing one switch that achieves the open state to create the high impedance when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

3. The method of claim 1, wherein providing at least one switch comprises providing a first switch that is coupled to the first actuator and that achieves the open state to create the open circuit when the first actuator reaches the first stop position and providing a second switch that is coupled to the second actuator and that achieves the open state to create the high impedance when the second actuator reaches the second stop position.

4. The method of claim 1, wherein a force from the magnetic field acting on the first actuator is at a maximum when a force from the magnetic field acting on the second actuator is at a minimum.

5. The method of claim 1, wherein providing the first actuator comprises positioning the first actuator coaxially with the second actuator and within a bore of the second actuator.

6. The method of claim 1, wherein providing the first actuator comprises providing a pin attached to a first piece of ferromagnetic material and a cylinder that surrounds the pin and is attached to a second piece of ferromagnetic material, wherein the first piece and the second piece are separated by a distance when the first actuator is in the first start position and wherein the distance decreases as the first actuator moves toward the first stop position.

7. The method of claim 1, wherein providing the second actuator comprises providing a cylinder that comprises alternating layers of ferromagnetic material and non-ferromagnetic material and providing an outer cylinder that surrounds the cylinder and comprises alternating layers of ferromagnetic material, such that the ferromagnetic material of the cylinder has a position in the direction of movement of the second actuator that is unaligned with a position in the direction of movement of the second actuator of the ferromagnetic material of the outer cylinder when the second actuator is in the second start position and wherein the position of the ferromagnetic material of the cylinder becomes more aligned in the direction of movement of the second actuator with the position of the ferromagnetic material of the outer cylinder as the second actuator moves toward the second stop position.

8. The method of claim 1, wherein the direction of movement of the first actuator is parallel to the direction of movement of the second actuator.

9. An implantable medical lead, comprising:

a lead body;

at least one conductor surrounded by the lead body;

at least one electrode coupled to the lead body on the distal end of the lead body;

a first magnetically responsive actuator within the lead body that when in a presence of a magnetic field of an MRI scanner moves from a first start position toward a first stop position and reaches the first stop position when the magnetic field is not oriented normal to a direction of movement of the first actuator;

a second magnetically responsive actuator within the lead body that when in the presence of the magnetic field moves from a second start position toward a second stop position and reaches the second stop position when the magnetic field is not oriented parallel to a direction of movement of the second actuator; and

at least one switch within the lead body that is coupled to the first and second switches and that is in series between the conductor and the electrode on the distal end of the lead body, the at least one switch residing in a closed state and achieving an open state to create a high impedance between the conductor and the electrode on the distal end of the lead body when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

10. The lead of claim 9, wherein the at least one switch comprises one switch that achieves the open state to create the high impedance when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

11. The lead of claim 9, wherein the at least one switch comprises:

a first switch that is coupled to the first actuator and that achieves the open state to create the high impedance when the first actuator reaches the first stop position; and

a second switch that is coupled to the second actuator and that achieves the open state to create the high impedance when the second actuator reaches the second stop position.

12. The lead of claim 9, wherein a force from the magnetic field acting on the first actuator is at a maximum when a force from the magnetic field acting on the second actuator is at a minimum.

13. The lead of claim 9, wherein the first actuator is positioned coaxially with the second actuator and within a bore of the second actuator.

14. The lead of claim 9, wherein the first actuator comprises a pin attached to a first piece of ferromagnetic material and a cylinder that surrounds the pin and is attached to a second piece of ferromagnetic material, wherein the first piece and the second piece are separated by a distance when the first actuator is in the first start position and wherein the distance decreases as the first actuator moves toward the first stop position.

15. The lead of claim 9, wherein the second actuator comprises a cylinder that comprises alternating layers of ferromagnetic material and non-ferromagnetic material and an outer cylinder that surrounds the cylinder and comprises alternating layers of ferromagnetic material, such that the ferromagnetic material of the cylinder has a position in the direction of movement of the second actuator that is unaligned with a position in the direction of movement of the second actuator of the ferromagnetic material of the outer cylinder when the second actuator is in the second start position and wherein the position of the ferromagnetic material of the cylinder becomes more aligned in the direction of movement of the second actuator with the position of the ferromagnetic material of the outer cylinder as the second actuator moves toward the second stop position.

16. The lead of claim 9, wherein the electrode on the distal end of the lead body is the most distal electrode on the lead body.

17. A medical system, comprising:

a pulse generator; and

an implantable medical lead that comprises;

a lead body;

at least one conductor surrounded by the lead body, the at least one conductor being electrically coupled to the pulse generator;

at least one electrode coupled to the lead body on the distal end of the lead body;

a first magnetically responsive actuator within the lead body that when in a presence of a magnetic field of an MRI scanner moves from a first start position toward a first stop position and reaches the first stop position when not oriented normal to a direction of movement of the first actuator;

a second magnetically responsive actuator within the lead body that when in the presence of a magnetic field moves from a second start position toward a second stop position and reaches the second stop position when not oriented parallel to a direction of movement of the second actuator; and

at least one switch within the lead body that is coupled to the first and second actuators and that is in series between the conductor and the electrode on the distal end of the lead body, the at least one switch residing in a closed state and achieving an open state to create a high impedance between the conductor and the electrode on the distal end of the lead body when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

18. The system of claim 17, wherein the at least one switch comprises one switch that achieves the open state to create the high impedance when the first actuator reaches the first stop position and/or when the second actuator reaches the second stop position.

19. The system of claim 17, wherein the at least one switch comprises:

a first switch that is coupled to the first actuator and that achieves the open state to create the high impedance when the first actuator reaches the first stop position; and

a second switch that is coupled to the second actuator and that achieves the open state to create the high impedance when the second actuator reaches the second stop position.

20. The system of claim 17, wherein a force from the magnetic field acting on the first actuator is at a maximum when a force from the magnetic field acting on the second actuator is at a minimum.

21. The system of claim 17, wherein the first actuator is positioned coaxially with the second actuator and within a bore of the second actuator.

22. The system of claim 17, wherein the first actuator comprises a pin attached to a first piece of ferromagnetic material and a cylinder that surrounds the pin and is attached to a second piece of ferromagnetic material, wherein the first piece and the second piece are separated by a distance when the first actuator is in the first start position and wherein the distance decreases as the first actuator moves toward the first stop position.

23. The system of claim 17, wherein the second actuator comprises a cylinder that comprises alternating layers of ferromagnetic material and non-ferromagnetic material and an outer cylinder that surrounds the cylinder and comprises alternating layers of ferromagnetic material, such that the ferromagnetic material of the cylinder has a position in the direction of movement of the second actuator that is unaligned with a position in the direction of movement of the second actuator of the ferromagnetic material of the outer cylinder when the second actuator is in the second start position and wherein the position of the ferromagnetic material of the cylinder becomes more aligned in the direction of movement of the second actuator with the position of the ferromagnetic material of the outer cylinder as the second actuator moves toward the second stop position.