RFID DETECTION AND IDENTIFICATION SYSTEM FOR IMPLANTABLE MEDICAL LEAD SYSTEMS

• US 20100321163A1
• Filed: 08/30/2010
• Published: 12/23/2010
• Est. Priority Date: 03/21/2005
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A.
• Granted Patent: US 8,326,435 B2
• Time in Patent Office: Days
• US Class Current: 340/10.1
• 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 medical implant within a patient, comprising the steps of:

associating a radio frequency identification (RFID) tag with an active implantable medical device (AIMD), or a leadwire system for the AIMD, or both, the RFID tag being readable or readable/writable and having previously stored retrievable information relating to the AIMD, its leadwire system, or both;

interrogating the RFID tag; and

retrieving information from the RFID tag relating to the AIMD, its leadwire system, or both.

2. The process of claim 1, wherein the retrievable information includes information pertaining to magnetic resonance imaging (MRI) compatibility of the AIMD, its leadwire system, or both.

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

4. The process of claim 1, including the step of disposing the RFID tag within a biocompatible and hermetically sealed container associated with the AIMD or its leadwire system.

5. The process of claim 2, including the step of attenuating current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

6. The process of claim 5, wherein current flow is attenuated through use of a bandstop filter associated with the leadwire system.

7. The process of claim 5, including the step of associating a bandstop filter with the leadwire system for each selected frequency range.

8. The process of claim 1, including the step of remotely writing information to the RFID tag pertaining to the AIMD, its leadwire system, or the patient.

9. The process of claim 1, including the step of retrieving information relating to the patient.

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

a radio frequency identification (RFID) tag associated with the medical implant, the RFID tag having retrievable information relating to the medical implant and, optionally, the patient, wherein the retrievable information includes information pertaining to the medical implant or its associated leadwire system, or both; and

means for changing the retrievable information to correspond to changes in characteristics of the medical device, the associated leadwire system, or the patient.

11. The system of claim 10, including a bandstop filter associated with the leadwire system for attenuating current flow through the leadwire system or the medical device at a selected frequency or frequency range.

12. The system of claim 10, including an interrogator for communicating with the RFID tag and retrieving the information therefrom.

13. The system of claim 12, wherein the interrogator comprises a read only or a reader/writer device.

14. The system of claim 12, wherein the interrogator communicates with a computer or computer network.

15. The system of claim 10, 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.

16. The system of claim 10, wherein the RFID tag is readable/writable.

17. The system of claim 10, wherein the RFID tag is attached to tissue adjacent to the leadwire system.

18. The system of claim 10, wherein the RFID tag is attached to a leadwire.

19. The system of claim 10, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container associated with the medical implant or the leadwire system.

20. The system of claim 11, wherein the bandstop filter comprises an electronic circuit in series with a leadwire, having capacitance in parallel with inductance, the capacitance and inductance being selected such that the bandstop filter is resonant at a selected frequency or frequency range so as to attenuate current flow through the leadwire at the selected frequency or frequency range.

21. The system of claim 20, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

22. The system of claim 11, wherein the RFID tag includes retrievable information relating to the bandstop filter.

23. The system of claim 20, including a plurality of bandstop filters associated with the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

24. The system of claim 10, wherein the medical device comprises cochlear implants, piezoelectric sound bridge transducers, neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, artificial hearts, drug pumps, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, pH probes, congestive heart failure devices, pill cameras, neuromodulators, cardiovascular stents, orthopedic implants, external insulin pumps, external drug pumps, external neurostimulators, Holter monitors, and external probes or catheters.

25. The system of claim 10, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container disposed within tissue of the patient.

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

a radio frequency identification (RFID) tag associated with a medical implant, the RFID tag having retrievable information relating to the medical implant, the patient, or both, wherein the retrievable information includes information pertaining to magnetic resonance imaging (MRI) compatibility of the medical implant or an associated leadwire system (if present), or both.

27. The system of claim 26, including a bandstop filter associated with the leadwire system for attenuating current flow through the leadwire system or the medical device at a selected frequency or frequency range.

28. The system of claim 26, including an interrogator for communicating with the RFID tag and retrieving the information therefrom.

29. The system of claim 28, wherein the interrogator comprises a read only or a reader/writer device.

30. The system of claim 28, wherein the interrogator communicates with a computer or computer network.

31. The system of claim 26, 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.

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

33. The system of claim 26, wherein the RFID tag is attached to tissue adjacent to the leadwire system.

34. The system of claim 26, wherein the RFID tag is associated with the medical implant or the leadwire system.

35. The system of claim 26, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container attached to the leadwire system.

36. The system of claim 27, wherein the bandstop filter comprises an electronic circuit in series with a leadwire, having capacitance in parallel with inductance, the capacitance and inductance being selected such that the bandstop filter is resonant at a selected frequency or frequency range so as to attenuate current flow through the leadwire at the selected frequency or frequency range.

37. The system of claim 36, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

38. The system of claim 27, wherein the RFID tag includes retrievable information relating to the bandstop filter.

39. The system of claim 36, including a plurality of bandstop filters associated with the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

40. The system of claim 26, wherein the medical device comprises cochlear implants, piezoelectric sound bridge transducers, neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, artificial hearts, drug pumps, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, pH probes, congestive heart failure devices, pill cameras, neuromodulators, cardiovascular stents, orthopedic implants, external insulin pumps, external drug pumps, external neurostimulators, Holter monitors, and external probes or catheters.

41. The system of claim 26, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container disposed within tissue of the patient.

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

associating a radio frequency identification (RFID) tag with a medical implant, a leadwire system for the medical implant (if present), or both, the RFID tag being readable or readable/writable and having previously stored retrievable information relating to the medical implant, its leadwire system, or both;

interrogating the RFID tag; and

retrieving information from the RFID tag relating to the medical implant, its leadwire system, or both.

43. The process of claim 42, wherein the retrievable information includes information pertaining to magnetic resonance imaging (MRI) compatibility of the medical implant, its leadwire system, or both.

44. The process of claim 42, including the step of communicating information retrieved from the RFID tag with a computer or computer network.

45. The process of claim 42, including the step of disposing the RFID tag within a biocompatible and hermetically sealed container associated with the medical implant or its leadwire system.

46. The process of claim 43, including the step of attenuating current flow through the leadwire system at one or more selected frequencies or ranges of frequencies.

47. The process of claim 46, wherein current flow is attenuated through use of a bandstop filter associated with the leadwire system.

48. The process of claim 46, including the step of associating a bandstop filter with the leadwire system for each selected frequency.

49. The process of claim 42, including the step of remotely writing information to the RFID tag pertaining to the medical implant, its leadwire system, or the patient.

50. The process of claim 42, including the step of retrieving information relating to the patient.

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

a radio frequency identification (RFID) tag associated with a medical implant, the RFID tag having retrievable information relating to the medical implant and, optionally, the patient, wherein the retrievable information includes information pertaining the medical implant or its associated leadwire system, or both; and

means for writing information to the RFID tag pertaining to characteristics of the medical device, an associated leadwire system (if present), or the patient.

52. The system of claim 51, including a bandstop filter associated with the leadwire system for attenuating current flow through the leadwire system or the medical device at a selected frequency or frequency range.

53. The system of claim 51, including an interrogator for communicating with the RFID tag and retrieving the information therefrom.

54. The system of claim 53, wherein the interrogator comprises a read only or a reader/writer device.

55. The system of claim 53, wherein the interrogator communicates with a computer or computer network.

56. The system of claim 51, 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.

57. The system of claim 51, wherein the RFID tag is readable/writable.

58. The system of claim 51, wherein the RFID tag is attached to tissue adjacent to the leadwire system.

59. The system of claim 51, wherein the RFID tag is attached to a leadwire.

60. The system of claim 51, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container associated with the medical implant or the leadwire system (if present).

61. The system of claim 52, wherein the bandstop filter comprises an electronic circuit in series with a leadwire, having capacitance in parallel with inductance, the capacitance and inductance being selected such that the bandstop filter is resonant at a selected frequency or frequency range so as to attenuate current flow through the leadwire at the selected frequency or frequency range.

62. The system of claim 61, wherein the selected frequency or frequency range corresponds to one or more MRI pulsed frequencies.

63. The system of claim 52, wherein the RFID tag includes retrievable information relating to the bandstop filter.

64. The system of claim 61, including a plurality of bandstop filters associated with the leadwire, each bandstop filter being resonant at a different frequency or frequency range.

65. The system of claim 51, wherein the medical device comprises cochlear implants, piezoelectric sound bridge transducers, neurostimulators, brain stimulators, cardiac pacemakers, ventricular assist devices, artificial hearts, drug pumps, bone growth stimulators, bone fusion stimulators, urinary incontinence devices, pain relief spinal cord stimulators, anti-tremor stimulators, gastric stimulators, implantable cardioverter defibrillators, pH probes, congestive heart failure devices, pill cameras, neuromodulators, cardiovascular stents, orthopedic implants, external insulin pumps, external drug pumps, external neurostimulators, Holter monitors, and external probes or catheters.

66. The system of claim 51, wherein the RFID tag is disposed within a biocompatible and hermetically sealed container disposed within tissue of the patient.