RFID-enabled AIMD programmer system for identifying MRI compatibility of implanted leads

• US 8,321,032 B2
• Filed: 08/30/2010
• Issued: 11/27/2012
• Est. Priority Date: 11/09/2006
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Frysz, Christine A., Stevenson, Robert A., Dabney, Warren S.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/871,201
• Publication Number:
  US 20110029043A1
• Time in Patent Office: 820 Days
• Field of Search: 607/115
• US Class Current: 607/115
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

An RFID tag is associated with an implantable lead, its sensing or therapy delivery electrode, or a patient, for identifying the MRI compatibility of the implantable lead and/or the presence of a bandstop filter and its attendant characteristics. An RFID-enabled AIMD external telemetry programmer transmits an electromagnetic signal to establish a communication link with the RFID tag.

Claims

1. An RFID-enabled AIMD programmer system for identifying the MRI compatibility of an implantable lead, the system comprising:

a) an implantable lead comprising a lead wire having a length extending from a proximal end that is electrically connectable to an active implantable medical device (AIMD) to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the lead wire somewhere along the length thereof;

b) an RFID tag attached to the implantable lead, the RFID tag having retrievable information relating to the MRI compatibility of the implantable lead under a static magnetic field or the ability of the bandstop filter to attenuate current flow through the lead at one or more selected frequencies or ranges of frequencies; and

c) an RFID-enabled AIMD external telemetry programmer which is configured to transmit an electromagnetic signal to establish a communication link with the RFID tag.

2. The system of claim 1, wherein the implantable lead is selected from the group consisting of a lead that is electrically connectable to an active implantable medical device (AIMD), an abandoned lead, a lead connected to an abandoned lead cap, and a lead that is electrically connectable to an active external medical device.

3. The system of claim 1, wherein the implantable lead is electrically connected to an active implantable medical device (AIMD) having electronic circuitry for therapy delivery or detection of biological signals.

4. The system of claim 3, wherein in addition to having retrievable information relating to the MRI compatibility of the implantable lead, the RFID tag includes retrievable information relating to at least one of the group consistina of the active implantable medical device, a patient, and a physician.

5. The system of claim 4, including means for changing information stored in the RFID tag to correspond to changes in characteristics of at least one of the AIMD, the implanted lead, and a patient.

6. The system of claim 3, wherein the retrievable information further pertains to the magnetic resonance imaging (MRI) compatibility of the AIMD.

7. The system of claim 3, wherein the AIMD is selected from the group consisting of a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a neurostimulator, a ventricular assist device, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion, a lead wire, and an abandoned lead.

8. The system of claim 1 or 3, wherein the electromagnetic signal of the AIMD external telemetry programmer is transmitted in an LF or an HF frequency range.

9. The system of claim 1, wherein the electromagnetic signal comprises an RFID communication signal.

10. The system of claim 1 or 9, wherein the AIMD external telemetry programmer comprises a read-only or a reader/writer device.

11. The system of claim 9, wherein the AIMD external telemetry programmer is configured for communication with a computer or a computer network.

12. The system of claim 11, including an electronic database or look-up table enabling the communication between the AIMD external telemetry programmer and the RFID tag.

13. The system of claim 12, wherein the electronic database or look-up table resides in the computer or computer network.

14. The system of claim 12, wherein the electronic database or look-up table resides in the AIMD external telemetry programmer.

15. The system of claim 1, wherein the electromagnetic signal is selected from the group consisting of an RFID interrogation signal, an RFID tag search signal, an RFID test signal, an RFID read signal, and an RFID write signal.

16. The system of claim 1, wherein the electromagnetic signal comprises a modulated signal.

17. The system of claim 1, wherein, when powered up, the AIMD external telemetry programmer is configured to actively search for or communicate with the RFID tag.

18. The system of claim 1, wherein the RFID tag comprises a read-only or a readable/writable RFID tag.

19. The system of claim 1, wherein the RFID tag comprises an antenna and an electronic micro-chip electrically connected to the antenna.

20. The system of claim 1, wherein the AIMD external telemetry programmer includes a circuit for limiting the total continuous transmit time of the electromagnetic signal, and a time-out circuit for delaying a subsequent transmission of the electromagnetic signal.

21. The system of claim 20, wherein the total continuous transmit time of the electromagnetic signal is no greater than five seconds.

22. The system of claim 20, wherein the time-out circuit delays the subsequent transmission of the electromagnetic signal for two seconds or more.

23. The system of claim 20, wherein the total continuous transmit time of the electromagnetic signal is 500 milliseconds or less.

24. The system of claim 20, including a switch in the RFID-enabled AIMD external telemetry programmer for temporarily actuating the total continuous transmit time limiting circuit and the time-out circuit.

25. The system of claim 1, wherein the electromagnetic signal comprises a modulated signal.

26. The system of claim 1 wherein the RFID tag includes information related to the MRI compatibility of the implantable lead under the static magnetic field of a strength ranging from 0.5 to 3.0 Tesla.

27. The system of claim 26 wherein the RFID tag is attached to the active implantable medical device.

28. The system of claim 26 wherein the RFID tag is attached to the lead.

29. The system of claim 26 wherein the RFID tag is carried on or in a patient.

30. The system of claim 26, wherein the retrievable information from the RFID tag includes a center frequency of attenuation for the bandstop filter.

31. The system of claim 26, wherein the RFID tag is attached to an object in close proximity to a patient being medically assisted by the active implantable medical device.

32. An RFID-enabled AIMD programmer system for identifying the MRI compatibility of an implanted lead, the system comprising:

a) an active implantable medical device (AIMD) having electronic circuitry for therapy delivery or detection of biological signals;

b) an implantable lead comprising a lead wire having a length extending from a proximal end that is electrically connected to the active implantable medical device (AIMD) to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the lead wire somewhere along the length thereof;

c) an RFID tag attached to at least one of the implantable lead, the AIMD, and a patient, the RFID tag having retrievable information relating to the MRI compatibility of the implantable lead under a static magnetic field or the ability of the bandstop filter to attenuate current flow through the lead at one or more selected frequencies or ranges of frequencies; and

d) an RFID-enabled AIMD external telemetry programmer which is configured to transmit an electromagnetic signal to establish a communication link with the RFID tag.

33. The system of claim 32 wherein the RFID tag includes information related to the MRI compatibility of the implantable lead under the static magnetic field of a strength ranging from 0.5 to 3.0 Tesla.

34. An RFID-enabled AIMD programmer system for identifying the MRI compatibility of an implantable lead, the system comprising:

a) an implantable lead comprising a lead wire having a length extending from a proximal end that is electrically connectable to an active implantable medical device (AIMD) to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the lead wire somewhere along the length thereof;

b) an RFID tag attached to the implantable lead, the RFID tag having retrievable information relating to the implantable lead; and

c) an RFID-enabled AIMD external telemetry programmer which is configured to transmit an electromagnetic signal to establish a communication link with the RFID tag, wherein the programmer includes a time-out circuit so that regardless whether an RFID tag is detected, or not, the programmer transmits a first electromagnetic signal having a first limited total continuous transmit time that is not greater than a defined transmit length, followed by an interim period of defined, manually non-resettable interim length where the time-out circuit renders the programmer incapable of transmitting the electromagnetic signal, followed by the programmer transmitting a second electromagnetic signal having a second limited total continuous transmit time that is not greater than the defined transmit length, and wherein no matter how frequently the programmer is actuated, the time-out circuit prevents the second and subsequent transmissions of the electromagnetic signal after a prior electromagnetic signal has been transmitted from the programmer until the interim period of the defined, manually non-resettable interim length has expired, and wherein the first, second and subsequent transmissions of the electromagnetic signal can be less, but not greater than, the defined transmit length.

35. The system of claim 34 wherein the total continuous transmit time of the electromagnetic signal is no greater than five seconds.

36. The system of claim 34 wherein the time-out circuit delays the subsequent transmission of the electromagnetic signal for two seconds or more.

37. The system of claim 34 wherein the total continuous transmit time of the electromagnetic signal is 500 milliseconds or less.

38. The system of claim 34 wherein the electromagnetic signal comprises a modulated signal.

39. The system of claim 34 including a switch in the RFID-enabled AIMD external telemetry programmer for temporarily actuating the total continuous transmit time limiting circuit and the time-out circuit.