Medical device electrical lead design for preventing transmittance of unsafe currents to a patient

• US 7,711,436 B2
• Filed: 04/24/2007
• Issued: 05/04/2010
• Est. Priority Date: 03/09/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stone, Richard T.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/739,386
• Publication Number:
  US 20080221568A1
• Time in Patent Office: 1,106 Days
• Field of Search: 607/63, 607/115, 607/116
• US Class Current: 607/63
• CPC Class Codes: A61B 2090/0481 against EM radiation, e.g. microwave
• 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 1/0534 Electrodes for deep brain stimulation
• 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

Abstract

An electrical lead including a conductor assembly, an electrode, and a thermally sensitive material. The conductor assembly has one or more conductors. The electrode is in electrical communication with one of the conductors and has an outer contact adapted for contacting adjacent body tissue of a patient. The thermally sensitive material is electrically connected between the one conductor and the electrode outer contact, and is configured to exhibit high impedance in the presence of currents considered unsafe to the patient, thereby preventing the unsafe currents from flowing through the thermally sensitive material and through the electrode outer contact potentially causing the adjacent body tissue to increase in temperature to an unsafe level. The unsafe currents cause the thermally sensitive material to increase in temperature, thereby causing the material to transition to a high impedance state.

Claims

1. An electrical lead, comprising:

a conductor assembly having one or more conductors;

an electrode in electrical communication with one of the conductors, the electrode having an outer contact adapted for contacting adjacent body tissue of a patient; and

a thermally sensitive material integrated with the electrode in forming an assembly, the thermally sensitive material being completely encased within the electrode and being electrically connected between the one conductor and the electrode outer contact so that current from the one conductor flows through a substantial portion of the thermally sensitive material in order to reach the outer contact, the thermally sensitive material configured to exhibit high impedance in the presence of currents considered unsafe to the patient, thereby preventing the unsafe currents from flowing through the substantial portion of the thermally sensitive material and through the electrode outer contact potentially causing the adjacent body tissue to increase in temperature to an unsafe level, the unsafe currents causing the thermally sensitive material to increase in temperature, thereby causing the material to transition to a high impedance state.

2. The electrical lead of claim 1, wherein the thermally sensitive material comprises positive temperature coefficient material.

3. The electrical lead of claim 1, wherein the thermally sensitive material is electrically connected in series between the one conductor and the electrode outer contact.

4. The electrical lead of claim 1, wherein the thermally sensitive material is sized so as to be internally positioned within the electrode outer contact.

5. The electrical lead of claim 4, wherein the assembly further includes an insulating material enclosing a majority of an outer surface of the thermally sensitive material, the insulating material hermetically sealing the thermally sensitive material within the electrode.

6. The electrical lead of claim 1, wherein the one conductor is electrically coupled to a proximal end portion of the thermally sensitive material and the electrode outer contact is electrically coupled to a distal end portion of the thermally sensitive material, wherein a conductive path between the one conductor and the electrode outer contact is established across the substantial portion of the thermally sensitive material.

7. The electrical lead of claim 6, wherein the assembly further comprises an insulating material enclosing a majority of an outer surface of the thermally sensitive material, thereby enhancing the conductive path between the one conductor and the electrode outer contact across the thermally sensitive material.

8. The electrical lead of claim 1, wherein the electrode further includes an inner contact, the electrode inner contact electrically connecting the one conductor to the thermally sensitive material.

9. The electrical lead of claim 8, wherein the assembly further comprises an insulating material that surrounds the thermally sensitive material except for locations in which the electrode outer contact and the electrode inner contact are in electrical contact with the thermally sensitive material.

10. An electrode, comprising:

an outer contact adapted for contacting adjacent body tissue of a patient;

an inner contact adapted for electrical coupling to a lead conductor; and

a thermally sensitive material electrically connected between the inner contact and the outer contact so that current from the one conductor flows through a substantial portion of the thermally sensitive material in order to reach the outer contact, the thermally sensitive material forming an assembly with the outer contact and inner contact whereby the thermally sensitive material is completely encased, the thermally sensitive material configured to exhibit high impedance in the presence of currents considered unsafe to the patient, thereby preventing the unsafe currents from flowing through the substantial portion of the thermally sensitive material and through the outer contact potentially causing the adjacent body tissue to increase in temperature to an unsafe level, the unsafe currents causing the thermally sensitive material to increase in temperature, thereby causing the material to transition to a high impedance state.

11. The electrode of claim 10, wherein the thermally sensitive material comprises positive temperature coefficient material.

12. The electrode of claim 10, wherein the thermally sensitive material is electrically connected in series between the inner contact and the outer contact.

13. The electrode of claim 10, wherein the thermally sensitive material is sized so as to be internally positioned within the outer contact.

14. The electrode of claim 10, wherein the inner contact is electrically coupled to a proximal end portion of the thermally sensitive material and the outer contact is electrically coupled to a distal end portion of the thermally sensitive material, wherein a conductive path between the inner contact and the outer contact is established across the substantial portion of the thermally sensitive material.

15. The electrode of claim 13, further comprising an insulating material enclosing a majority of an outer surface of the thermally sensitive material, the insulating material hermetically sealing the thermally sensitive material between the inner contact and the outer contact.

16. A method of providing an electrical lead configured to prevent currents considered unsafe to a patient, comprising:

providing a conductor assembly having one or more conductors;

providing an electrode in electrical communication with one of the conductors, the electrode having an outer contact adapted for contacting adjacent body tissue of a patient;

integrating a thermally sensitive material with the electrode to form an assembly such that the thermally sensitive material is completely encased within the electrode; and

electrically connecting the thermally sensitive material between the one conductor and the electrode outer contact so that current from the one conductor flows through a substantial portion of the thermally sensitive material in order to reach the electrode outer contact, the thermally sensitive material configured to exhibit high impedance in the presence of currents considered unsafe to the patient, thereby preventing the unsafe currents from flowing through the substantial portion of the thermally sensitive material and through the electrode outer contact potentially causing the adjacent body tissue to increase in temperature to an unsafe level, the unsafe currents causing the thermally sensitive material to increase in temperature, thereby causing the material to transition to a high impedance state.

17. The method of claim 16, wherein the thermally sensitive material upon reaching a certain temperature exhibits significant increased resistance upon further increases in temperature.

18. The method of claim 16, wherein the thermally sensitive material is electrically connected in series between the one conductor and the electrode outer contact.

19. The method of claim 16, wherein the thermally sensitive material is sized so as to be internally positioned within the electrode outer contact.

20. The method of claim 19, wherein the assembly further includes an insulating material enclosing a majority of an outer surface of the thermally sensitive material, the insulating material hermetically sealing the thermally sensitive material within the electrode.

21. The method of claim 16, wherein the one conductor is electrically coupled to a proximal end portion of the thermally sensitive material and the electrode outer contact is electrically coupled to a distal end portion of the thermally sensitive material, wherein a conductive path between the one conductor and the electrode outer contact is established across the substantial portion of the thermally sensitive material.

22. The method of claim 21, wherein the assembly further comprises an insulating material enclosing a majority of an outer surface of the thermally sensitive material, thereby enhancing the conductive path between the one conductor and the electrode outer contact across the thermally sensitive material.

23. The method of claim 16, wherein the electrode further includes an inner contact, the electrode inner contact electrically connecting the one conductor to the thermally sensitive material.

24. The method of claim 23, wherein the assembly further comprises an insulating material that surrounds the thermally sensitive material except for locations in which the electrode outer contact and the electrode inner contact are in electrical contact with the thermally sensitive material.

25. An electrical lead, comprising:

a conductor assembly having one or more conductors;

an electrode in electrical communication with one of the conductors, the electrode having an outer contact adapted for contacting adjacent body tissue of a patient; and

a positive temperature coefficient material integrated with the electrode in forming an assembly, the positive temperature coefficient material being completely encased within the electrode and being electrically connected between the one conductor and the electrode outer contact so that current from the one conductor flows through a substantial portion of the positive temperature cofficient material in order to reach the electrode outer contact, the positive temperature coefficient material integrated into an assembly with the electrode, the positive temperature coefficient material configured to exhibit high impedance in the presence of currents considered unsafe to the patient, thereby preventing the unsafe currents from flowing through the substantial portion of the positive temperature coefficient material and through the electrode outer contact potentially causing the adjacent body tissue to increase in temperature to an unsafe level, the unsafe currents causing the positive temperature coefficient material to increase in temperature, thereby causing the material to transition to a high impedance state.

26. The electrical lead of claim 25, wherein the positive temperature coefficient material is electrically connected in series between the one conductor and the electrode outer contact.

27. The electrical lead of claim 25, wherein the positive temperature coefficient material is sized so as to be internally positioned within the electrode outer contact.

28. The electrical lead of claim 25, wherein the one conductor is electrically coupled to a proximal end portion of the positive temperature coefficient material and the electrode outer contact is electrically coupled to a distal end portion of the positive temperature coefficient material, wherein a conductive path between the one conductor and the electrode outer contact is established across the substantial portion of the positive temperature coefficient material.

29. The electrical lead of claim 28, wherein the assembly further comprises an insulating material enclosing a majority of the outer surface of the positive temperature coefficient material, thereby enhancing the conductive path between the one conductor and the electrode outer contact across the positive temperature coefficient material.

30. The electrical lead of claim 27, wherein the assembly further includes an insulating material enclosing a majority of an outer surface of the positive temperature coefficient material, the insulating material hermetically sealing the thermally sensitive material within the electrode.