RFID detection and identification system for implantable medical lead systems

• US 8,326,435 B2
• Filed: 08/30/2010
• Issued: 12/04/2012
• Est. Priority Date: 03/21/2005
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/871,016
• Publication Number:
  US 20100321163A1
• Time in Patent Office: 827 Days
• Field of Search: 607/115
• US Class Current: 607/115
• CPC Class Codes: A61B 1/00059 provided with identification means for the endoscope
• 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
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3754 Feedthroughs

Abstract

A system for identifying active implantable medical devices (AIMD) and lead systems implanted in a patient using a radio frequency identification (RFID) tag having retrievable information relating to the AIMD, lead system and/or patient. The RFID tag may store information about the AIMD manufacturer, model number, serial number; leadwire system placement information and manufacturer information; MRI compatibility due to the incorporation of bandstop filters; patient information, and physician and/or hospital information and other relevant information. The RFID tag may be affixed or disposed within the AIMD or leadwires of the lead system, or surgically implanted within a patient adjacent to the AIMD or leadwire system.

Claims

1. A process for identifying a leadwire system implanted within a patient, comprising the steps of:

a) providing a leadwire system comprising a leadwire 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 leadwire somewhere along the length thereof;

b) attaching a radio frequency identification (RFID) tag to the leadwire system, the RFID tag having retrievable information relating to the leadwire system;

c) interrogating the RFID tag; and

d) retrieving information from the RFID tag relating to the magnetic resonance imaging MRI compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

2. The process of claim 1, including the step of communicating information retrieved from the RFID tag to a computer or computer network.

3. The process of claim 1, including the step of disposing the RFID tag within a biocompatible and hermetically sealed container attached to the leadwire system.

4. The process of claim 1, including the step of electrically connecting a bandstop filter in series with the leadwire for each of the more than one selected frequencies or frequency ranges.

5. The process of claim 1, including the step of remotely writing information to the RFID tag pertaining to the leadwire system.

6. The process of claim 1 including providing the RFID tag containing 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.

7. A system for identifying a medical implant within a patient, comprising:

a) a leadwire system comprising a leadwire having a length extending from a proximal end that is electrically connected to a medical implant to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the leadwire somewhere along the length thereof;

b) a radio frequency identification (RFID) tag associated with the medical implant, the RFID tag having retrievable information; and

c) means for changing the retrievable information to correspond, to changes in characteristics of the leadwire system,

d) wherein at least some of the retrievable information relates to the magnetic resonance imaging (MRI) compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

8. The system of claim 7, including an interrogator for communicating with the RFID tag and retrieving the information therefrom.

9. The system of claim 8, wherein the interrogator comprises a read only or a reader/writer device.

10. The system of claim 8, wherein the interrogator is configured to communicate with a computer or computer network.

11. The system of claim 7, wherein the RFID tag comprises a substrate, an antenna disposed on the substrate, and a chip electrically connected to the antenna and adapted to store the retrievable information.

12. The system of claim 7, wherein the RFID tag is readable/writable.

13. The system of claim 7, wherein the RFID tag is attached to tissue adjacent to the leadwire system.

14. The system of claim 7, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container attached to the leadwire system.

15. The system of claim 7, wherein the bandstop filter comprises an electronic circuit in series with the leadwire, the electronic circuit having capacitance in parallel with inductance, the capacitance and inductance being configured such that the bandstop filter is resonant at the selected frequency or frequency range so as to attenuate current flow through the leadwire system at the selected frequency or frequency range.

16. The system of claim 15, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

17. The system of claim 15, including a plurality of bandstop filters electrically connected in series with the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

18. The system of claim 7, wherein the medical implant is selected from the group consisting of neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, congestive heart failure devices, neuromodulators, external neurostimulators, probes, and catheters.

19. The system of claim 7, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container disposed within tissue of the patient.

20. The system of claim 7 including providing the RFID tag containing 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.

21. A system for retrieving medical information from a patient, comprising:

a) a leadwire system comprising a leadwire having a length extending from a proximal end that is electrically connected to a medical implant to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the leadwire somewhere along the length thereof;

b) a radio frequency identification (RFID) tag attached to a medical implant or the leadwire system, the RFID tag having retrievable information relating to at least the leadwire system,

c) wherein at least some of the retrievable information relates to the magnetic resonance imaging (MRI) compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

22. The system of claim 21, including an interrogator configured for communication with the RFID tag and for retrieval of the information therefrom.

23. The system of claim 22, wherein the interrogator comprises a read only or a reader/writer device.

24. The system of claim 22, wherein interrogator is configured to communicate with a computer or computer network.

25. The system of claim 21, wherein the RFID tag comprises a substrate, an antenna disposed on the substrate, and a chip electrically connected to the antenna and adapted to store the information.

26. The system of claim 21, wherein the RFID tag is read only or readable/writable.

27. The system of claim 21, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container attached to the leadwire system.

28. The system of claim 21, wherein the bandstop filter comprises an electronic circuit in series with the leadwire, the electronic circuit having capacitance in parallel with inductance, the capacitance and inductance being configured such that the bandstop filter is resonant at the selected frequency or frequency range so as to attenuate current flow through the leadwire system at the selected frequency or frequency range.

29. The system of claim 28, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

30. The system of claim 28, including a plurality of bandstop filters attached to the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

31. The system of claim 21, wherein the medical implant is selected from the group consisting of neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, congestive heart failure devices, neuromodulators, external neurostimulators, external probes, and catheters.

32. The system of claim 21 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.

33. A process for identifying a medical implant within a patient, comprising the steps of:

a) providing a leadwire system comprising a leadwire having a length extending from a proximal end that is electrically connectable to a medical implant to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the leadwire somewhere along the length thereof;

b) electrically connecting leadwire system to a medical implant;

c) attaching a radio frequency identification (REID) tag to the medical implant or the leadwire system, the RFID tag being readable or readable/writable and having retrievable information relating to at least the leadwire system;

d) interrogating the RFID tag; and

e) retrieving information from the RFID tag relating to the magnetic resonance imaging (MRI) compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

34. The process of claim 33, including the step of communicating information retrieved from the RFID tag to a computer or computer network.

35. The process of claim 33, including the step of disposing the RFID tag within a biocompatible and hermetically sealed container associated with the medical implant or the leadwire system.

36. The process of claim 33, including the step of associating a bandstop filter with the leadwire system for each of the more than one selected frequencies or frequency ranges.

37. The process of claim 33, including the step of remotely writing information to the RFID tag pertaining to the leadwire system.

38. The process of claim 33, including the step of retrieving information from the RFID tag relating to a patient in whose body the medical implant including the leadwire system resides.

39. The process of claim 33 including providing the RFID tag containing 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.

40. A system for identifying a medical implant within a patient, comprising:

a) a leadwire system comprising a leadwire having a length extending from a proximal end that is electrically connected to a medical implant to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the leadwire somewhere along the length thereof;

b) a radio frequency identification (RFID) tag associated with the medical implant, the RFID tag having retrievable information pertaining to at least the leadwire system; and

c) means for writing information to the RFID tag pertaining to characteristics of at least the leadwire system,

d) wherein at least some of the retrievable information relates to the magnetic resonance imaging (MRI) compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

41. The system of claim 40, including an interrogator configured for communication with the RFID tag and for retrieving the information therefrom.

42. The system of claim 41, wherein the interrogator comprises a read only or a reader/writer device.

43. The system of claim 41, wherein the interrogator is configured to communicate with a computer or computer network.

44. The system of claim 40, wherein the RFID tag comprises a substrate, an antenna disposed on the substrate, and a chip electrically connected to the antenna and adapted to store the information.

45. The system of claim 40, wherein the RFID tag is readable/writable.

46. The system, of claim 40, wherein the RFID tag is attached to tissue adjacent to the leadwire system.

47. The system of claim 40, wherein the RFID tag is attached to the leadwire system.

48. The system of claim 40, wherein, the RFID tag is disposed within a biocompatible and hermetically sealed container attached to the medical implant or the leadwire system.

49. The system of claim 40, wherein the bandstop filter comprises an electronic circuit in series with a leadwire, the electronic circuit having capacitance in parallel with inductance, the capacitance and inductance being configured such that the bandstop filter is resonant at the selected frequency or frequency range so as to attenuate current flow through the leadwire system at the selected frequency or frequency range.

50. The system of claim 49, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

51. The system of claim 49, including a plurality of bandstop filters associated with the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

52. The system of claim 40, wherein the medical implant is selected from the group consisting of neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, congestive heart failure devices, neuromodulators, external neurostimulators, external probes, and catheters.

53. The system of claim 40, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container disposed within tissue of the patient.

54. The system of claim 40 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.

55. An implantable leadwire system, which comprises:

a) a leadwire 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 leadwire somewhere along the length thereof;

b) a radio frequency identification (RFID) tag attached to the leadwire system, the RFID tag being readable or readable/writable and having retrievable information relating to the leadwire system;

wherein at least some of the retrievable information, relates to the magnetic resonance imaging (MRI) compatibility of the leadwire system under at least one of a static magnetic field and the ability of the bandstop filter to attenuate current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

56. The system of claim 55 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.

57. A system for identifying a medical implant within a patient, comprising:

a) a leadwire system comprising a leadwire having a length extending from a proximal end that is electrically connected to a medical implant to a distal end electrically connected to an electrode, wherein a bandstop filter is electrically connected in series with the leadwire somewhere along the length thereof;

b) a radio frequency identification (RFID) tag attached to the medical implant, the RFID tag having retrievable information relating to the leadwire system; and

means for changing the retrievable information to correspond to changes in characteristics of the leadwire system,

wherein at least some of the retrievable information relates to the magnetic resonance imaging (MRI) compatibility of the leadwire system including the ability of the bandstop filter to attenuate current flow through the leadwire under at least one of a static magnetic field and at one or more selected frequencies or ranges of frequencies.

58. The system of claim 57 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.