System and method for controlling an implantable medical device subject to magnetic field or radio frequency exposure

• US 7,242,981 B2
• Filed: 06/30/2003
• Issued: 07/10/2007
• Est. Priority Date: 06/30/2003
• Status: Expired due to Term

• Current Assignee: Medos International Sarl (Johnson & Johnson)
• Original Assignee: Codman Neuro Sciences Sarl (Johnson & Johnson)
• Inventors: Ginggen, Alec
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): Gilbert; Andrew
• Application Number:
  US10/610,445
• Publication Number:
  US 20040267233A1
• Time in Patent Office: 1,471 Days
• Field of Search: 604/502, 604/890.1, 604/891.1, 604/892.1, 604/500, 604/506, 607/27, 607/9, 128/898
• US Class Current: 607/27
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

A system for controlling an implantable medical device (e.g., a drug delivery device) susceptible to malfunctioning during exposure to a magnetic field and/or Radio Frequency field (e.g., during a magnetic resonance imaging procedure) and a method for operating the same. Exposure of the implantable device to the magnetic field and/or the Radio Frequency field is detected using the sensing device. When the detected magnetic field and/or Radio Frequency field exceeds a corresponding predetermined threshold level, an input signal is generated at the microcontroller. In response to the generated input signal, the microcontroller automatically triggers (i) a safety mode enabling a predetermined safety mode operation that alters some operation, without ceasing all operation, of the implantable medical device and/or (ii) after expiration of a predetermined safety mode time interval when the at least one field being detected falls below its corresponding predetermined threshold level or a predetermined period of time elapses, a self testing mode enabling a predetermined self testing operation to verify proper operation of the implantable medical device. Preferably, both the safety and self testing modes are automatically triggered.

Claims

1. A method for operating a system for controlling an implantable drug delivery device susceptible to malfunctioning during exposure to at least one of a magnetic field or a Radio Frequency field, the method comprising the steps of:

detecting exposure of the implantable device to the at least one of the magnetic field or the Radio Frequency field using a sensing device;

when the at least one field being detected exceeds a corresponding predetermined threshold level, generating an input signal at a microcontroller;

automatically triggering, in response to the generated input signal, a safety mode enabling a predetermined safety mode operation that comprises;

(i) duplicating all data, (ii) saving all data to a memory, (iii) short circuiting a transmitter/receiver of the implantable drug delivery device, (iv) reverting to a default operation of the implantable drug delivery device stored in a non-volatile memory at the time of implantation, (v) calculating memory checksums to be verified during the self testing mode, (vi) store data detected by the sensing device, and (vii) ceasing delivery of drugs.

2. The method in accordance with claim 1, wherein the sensing device comprises a plurality of Reed switches or a plurality of Hall Magnetic Sensors.

3. The method in accordance with claim 1, further comprising the step of:

automatically triggering, in response to the generated input signal, after expiration of a predetermined safety mode time interval when the at least one field being detected falls below its corresponding predetermined threshold level or a predetermined period of time elapses, a self testing mode enabling a predetermined self testing operation to verify proper operation of the implantable medical device.

4. The method in accordance with claim 3, wherein the safety mode is automatically triggered followed by the self testing mode, the predetermined safety mode operation continuing simultaneously with the predetermined self testing mode operation.

5. The method in accordance with claim 3

wherein the predetermined self testing mode operation comprises at least one of:

(i) verifying of memory contents and (ii) testing operation of memory device of the implantable medical device.

6. The method in accordance with claim 4, further comprising, if no error in operation is detected during the self testing mode, disabling the predetermined safety mode operation.

7. The method in accordance with claim 4, further comprising the steps of:

when an error in operation is detected during the self testing mode, indicating that the error has been detected; and

disabling the predetermined safety mode operation when the error in operation has been corrected.