SWITCH FOR TURNING OFF THERAPY DELIVERY OF AN ACTIVE IMPLANTABLE MEDICAL DEVICE DURING MRI SCANS

• US 20090163980A1
• Filed: 12/17/2008
• Published: 06/25/2009
• Est. Priority Date: 12/21/2007
• Status: Abandoned Application

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A.
• Application Number:
  US12/337,170
• Publication Number:
  US 20090163980A1
• Time in Patent Office: Days
• US Class Current: 607/63
• 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

Abstract

An MRI-compatible electronic medical therapy system is provided for temporarily preventing current flow through an implanted lead wire in the presence of an induced radio frequency, magnetic, or static field. One or more normally closed switches are disposed in series between the AIMD and the one or more distal electrodes. The switch may be incorporated in the AIMD, lead wire, or within or adjacent to the electrode. The switch remains closed during normal AIMD-related therapy, but temporarily opens in the presence of an induced radio frequency, magnetic, or static field so as to prevent current flow through the electrode and lead wire. The switches prevent current from circulating that could be induced by a medical therapeutic diagnostic device, which can cause overheating of lead wires, excessive currents or temperatures and tissue damage.

Claims

1. An MRI-compatible electronic medical therapy system, comprising:

an active medical device (AMD);

a lead wire having a first end extending from the AMD to a distal electrode at a second end thereof for contact with biological cells; and

a normally closed switch incorporated into the lead wire or the electrode so as to be in electrical series with the lead wire, wherein the switch remains closed during normal AMD-related therapy, but temporarily opens in the presence of an induced electromagnetic field so as to create an open circuit between the electrode and the AMD to prevent damage to biological cells in contact with the lead wire or electrode.

2. The system of claim 1, wherein the AMD comprises a cochlear implant, a piezoelectric sound bridge transducer, a neurostimulator, a brain stimulator, a cardiac pacemaker, a ventricular assist device, an artificial heart, a drug pump, a bond growth stimulator, a bone growth stimulator, a bone fusion stimulator, a urinary incontinence device, a pain relief spinal cord stimulator, an anti-tremor stimulator, a gastric stimulator, an implantable cardioverter defibrillator, a pH probe, a congestive heart failure device, a pill camera, a neuromodulator, a cardiovascular stent, an orthopedic implant, an external insulin pump, an external drug pump, an external neurostimulator, a Holter monitor, an external probe, or a catheter.

3. The system of claim 1, wherein the induced electromagnetic field comprises a radio frequency, magnetic, or static field.

4. The system of claim 3, wherein the switch comprises a normally closed switching element creating a closed circuit between the electrode and the AMD, and which is automatically moved to an open position to create an open circuit in the presence of the induced radio frequency, electrostatic or magnetic field.

6. The system of claim 1, wherein the switch comprises a Micro-Electromechanical System (MEMS) switch.

7. The system of claim 6, wherein the MEMS switch includes a micro-electrostatic relay activated in the presence of an electrostatic field.

8. The system of claim 6, wherein the MEMS switch includes a micro-magnetic relay activated in the presence of a magnetic field.

9. The system of claim 6, wherein the MEMS switch comprises a resistive-type or a capacitive-type MEMS switch.

10. The system of claim 1, wherein the switch comprises a radio frequency (RF) activated switch.

11. The system of claim 1, wherein the switch comprises a switch assembly having multiple switches or switch relays.

12. The system of claim 1, including an RF device disposed adjacent to the switch for selectively applying an electromagnetic field to the switch upon activation of the RF device.

13. The system of claim 1, wherein the lead wire is adapted for insertion into a venous system or biological tissue.

14. The system of claim 1, wherein the lead wire comprises an epicardial lead, a split-cylinder cuff electrode, a self-sizing nerve cuff, a multiple-cuff nerve electrode, or a deep brain probe.

15. The system of claim 14, wherein the epicardial lead, a split-cylinder cuff electrode, a self-sizing nerve cuff, a multiple-cuff nerve electrode, or a deep brain probe incorporates a switch therein.

5. The system of claim 5, wherein the switching element automatically closes on removal of the induced radio frequency, electrostatic or magnetic field.

16. A medical device, comprising:

a medical device for administering therapy or receiving signals including an electronic circuit operably connected to a power source;

an electrode electrically connected to the electronic circuit of the medical device and adapted for insertion into or connection to biological tissue;

a switch disposed in electrical series with the electrode and the electronic circuit, wherein the switch is normally closed to establish a connection between the electrode and the medical device electronic circuit, but automatically temporarily open to prevent current flow between the electrode and the electronic circuit of the medical device in the presence of an induced radio frequency, static or magnetic field without interrupting the connection between the power source and the electronic circuit of the medical device, and close again to reestablish electrical connection between the electrode and the medical device electronic circuit after removal of the induced radio frequency, static or magnetic field.

17. The device of claim 16, wherein the medical device comprises a cochlear implant, a piezoelectric sound bridge transducer, a neurostimulator, a brain stimulator, a cardiac pacemaker, a ventricular assist device, an artificial heart, a drug pump, a bond growth stimulator, a bone growth stimulator, a bone fusion stimulator, a urinary incontinence device, a pain relief spinal cord stimulator, an anti-tremor stimulator, a gastric stimulator, an implantable cardioverter defibrillator, a pH probe, a congestive heart failure device, a pill camera, a neuromodulator, a cardiovascular stent, an orthopedic implant, an external insulin pump, an external drug pump, an external neurostimulator, a Holter monitor, an external probe, or a catheter.

18. The device of claim 16, wherein the switch comprises a normally closed switching element creating a closed circuit between the electrode and the medical device, and which is automatically moved to an open position to create an open circuit in the presence of the induced radio frequency, electrostatic or magnetic field and automatically closed on removal of the induced radio frequency, electrostatic or magnetic field.

19. The device of claim 16, wherein the switch comprises a Micro-Electromechanical System (MEMS) switch.

20. The device of claim 19, wherein the MEMS switch includes a micro-electrostatic relay activated in the presence of an electrostatic field.

21. The device of claim 19, wherein the MEMS switch includes a micro-magnetic relay activated in the presence of a magnetic field.

22. The device of claim 19, wherein the MEMS switch comprises a resistive-type or a capacitive-type MEMS switch.

23. The device of claim 16, wherein the switch comprises a radio frequency (RF) activated switch.

24. The device of claim 16, wherein the switch comprises a switch assembly having multiple switches or switch relays.

25. The device of claim 16, including an RF device disposed adjacent to the switch for selectively applying an electromagnetic field to the switch upon activation of the RF device.

26. The device of claim 16, including a lead wire disposed between the medical device and the electrode.

27. The device of claim 26, wherein the lead wire is adapted for insertion into a venous system or biological tissue.

28. The device of claim 26, wherein the lead wire comprises an epicardial lead, a split-cylinder cuff electrode, a self-sizing nerve cuff, a multiple-cuff nerve electrode, or a deep brain probe.

29. The device of claim 28, wherein the epicardial lead, a split-cylinder cuff electrode, a self-sizing nerve cuff, a multiple-cuff nerve electrode, or a deep brain probe incorporates a switch therein.

30. A method for preventing current generated from diagnostic or therapeutic energy from circulating between an electrode disposed within a human body and a medical device operably connected to the electrode, comprising the steps of:

providing a medical device having an electronic circuit designed to administer therapy or receive signals via an electrode electrically connected to the medical device;

incorporating a switch in series with the electrode and the electronic circuit of the medical device, the switch configured to prevent electric current from flowing between the electrode and the medical device electronic circuit, but not preventing current flow between a power source of the medical device and the electronic circuit;

disposing the electrode and the switch into the human body;

opening the switch to prevent current to flow between the electrode and the medical device electronic circuit during exposure of the human body to non-medical device related diagnostic or therapeutic electromagnetic energy, in order to prevent undesirable generation of current between the electrode and the medical device electronic circuit by exposure to the diagnostic or therapeutic electromagnetic energy; and

closing the switch after exposure of the human body to the diagnostic or therapeutic electromagnetic energy to reestablish electrical connection between the electrode and the medical device electronic circuit.

31. The method of claim 30, wherein the opening step comprises selectively opening the switch utilizing a magnetic field.

32. The method of claim 30, wherein the opening step comprises selectively opening the switch utilizing an electrostatic field.

33. The method of claim 30, wherein the opening step comprises selectively opening the switch utilizing a radio frequency circuit in electrical communication with the switch.

34. The method of claim 30, wherein the incorporating step includes the step of incorporating a MEMS switch into the electrode or between the electrode and the electronic circuit of the medical device.

35. A method for temporarily preventing current flow through an implanted lead wire in the presence of an induced static, radio frequency or magnetic field, comprising the steps of:

incorporating a switch in series with the lead wire between proximal and distal ends thereof;

electrically connecting the proximal end of the lead wire to an active implantable medical device (AIMD);

maintaining the switch in a closed state so as to create a closed circuit between the distal end of the lead wire and the AIMD during normal AIMD-related therapy;

automatically opening the switch to create an open circuit in the presence of an induced static, radio frequency or magnetic field; and

automatically closing the switch to create a closed circuit on removal of the induced static, radio frequency or magnetic field.

36. The method of claim 35, wherein the opening step comprises opening the switch utilizing a radio frequency circuit in electrical communication with the switch.

37. The method of claim 35, wherein the incorporating step includes the step of incorporating a MEMS switch into the lead wire or the AIMD.