RFID DETECTION AND IDENTIFICATION SYSTEM FOR IMPLANTABLE MEDICAL DEVICES

• US 20060212096A1
• Filed: 01/25/2006
• Published: 09/21/2006
• Est. Priority Date: 03/21/2005
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch-Sierra, Inc.
• Inventors: Stevenson, Robert A.
• Granted Patent: US 7,916,013 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• 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 1/37211 Means for communicating with stimulators
• CPC Class Codes: G06K 19/07749 the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A radio frequency identification (RFID) system for use with active implantable medical devices (AIMD) implanted in a patient comprises an interrogator and an RFID tag comprising a substrate, an RFID chip, and an antenna. The RFID is typically enclosed in a biocompatible and hermetically sealed container comprising a ceramic housing, an end cap and an encapsulant. The RFID tag or sealed container may be affixed to an AIMD or surgically implanted in a patient adjacent to an AIMD. Alternatively, the sealed container may be injected into body tissue by a large needle syringe. The RFID tag may store information about an AIMD including manufacturer, model number and serial number. The RFID tag may also store information about a treating physician and/or patient including the treating physician'"'"'s name and contact information, the patient'"'"'s name, contact information, medical condition, treatment and other relevant information.

Claims

1. A system for identifying implants within a patient, comprising:

an implantable medical device;

a hermetically sealed radio frequency identification (RFID) tag associated with the implantable medical device, the RFID tag containing information relating to the patient and/or the implantable medical device; and

an interrogator capable of communicating with the RFID tag.

2. The system of claim 1, wherein the implantable medical device comprises an active implantable medical device including a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion or a prosthetic device, and component parts thereof, including lead wires or abandoned lead wires.

3. The system of claim 1, wherein the RFID tag includes an antenna.

4. The system of claim 1, wherein the implantable medical device includes a header block and the RFID tag is implanted in the header block.

5. The system of claim 1, wherein the hermetically sealed container in which the RFID tag is disposed, is biocompatible and has a leak rate of no more than 10⁻

7 cubic centimeters per second.

6. The system of claim 5, wherein the container comprises a housing taken from the group including ceramic, glass, porcelain, sapphire and composites thereof, and specialty polymer composites.

7. The system of claim 6, including a desiccant within the housing.

8. The system of claim 6, wherein the container comprises an encapsulant within the housing surrounding at least a portion of the RFID tag.

9. The system of claim 8, wherein the encapsulant is comprised of a thermal-setting polymer or a silicone material.

10. The system of claim 5, wherein the container further includes an end cap hermetically sealed to the housing.

11. The system of claim 5, wherein the container further includes a fixation hole for affixing the container to body tissue, an implantable device, or a lead wire.

12. The system of claim 5, further comprising an X-ray identification tag associated with the biocompatible and hermetically sealed container.

13. The system of claim 1, wherein the RFID tag is read-only or readable/writable.

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

15. The system of claim 1, wherein the interrogator is in communication with a computer or computer network.

16. A system for identifying implants within a patient, comprising:

an active implantable medical device;

a hermetically sealed radio frequency identification (RFID) tag associated with the active implantable medical device, the RFID tag including an antenna and containing information relating to the patient and/or the active implantable medical device, wherein the RFID tag is read-only or readable/writable; and

an interrogator capable of communicating with the RFID tag.

17. The system of claim 16, wherein the interrogator is a reader/writer device.

18. The system of claim 17, wherein the interrogator is in communication with a computer or computer network.

19. The system of claim 16, wherein the active implantable medical device comprises a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion or a prosthetic device, and component parts thereof, including lead wires or abandoned lead wires.

20. The system of claim 16 wherein the active implantable medical device includes a header block and the RFID tag is implanted in the header block.

21. The system of claim 16, including a biocompatible and hermetically sealed container in which the RFID tag is disposed, wherein the container comprises a housing, an encapsulant within the housing surrounding at least a portion of the RFID tag, and an end cap hermetically sealed to the housing.

22. The system of claim 21, wherein the container has a leak rate of no more than 10⁻

7 cubic centimeters per second.

23. The system of claim 21, wherein the encapsulant is comprised of a thermal-setting polymer or a silicone material.

24. The system of claim 21, wherein the container further includes a fixation hole for affixing the container to body tissue, an implantable device, or a lead wire.

25. The system of claim 21, further comprising an X-ray identification tag affixed to the biocompatible and hermetically sealed container.

26. A system for identifying implants within a patient, comprising:

an active implantable medical device including a header block;

a radio frequency identification (RFID) tag disposed within the header block, the RFID tag containing information relating to the patient and/or the active implantable medical device; and

an interrogator capable of communicating with the RFID tag.

27. The system of claim 26, wherein the active implantable medical device comprises a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion or a prosthetic device, and component parts thereof, including lead wires or abandoned lead wires.

28. The system of claim 26, wherein the RFID tag includes an antenna and is read-only or readable/writable, the interrogator is a reader/writer device, and wherein the interrogator is in communication with a computer or computer network.

29. The system of claim 26, further comprising an X-ray identification tag associated with the RFID tag.

30. A process for manufacturing a radio frequency identification device (RFID) for identifying an implant within a patient, comprising the steps of:

associating a hermetically sealed RFID tag with an implantable medical device;

storing information relating to the patient or the implantable medical device on the RFID tag; and

implanting the RFID tag in the patient.

31. The process of claim 30, further comprising the step of embedding the RFID tag in a header block of the active implantable medical device.

32. The process of claim 30, further comprising the step of encasing the RFID tag in a biocompatible container including a housing taken from the group including ceramic, glass, porcelain, sapphire and composites thereof, and specialty polymer composites.

33. The process of claim 32, including a desiccant within the housing.

34. The process of claim 32, including an encapsulant within the housing surrounding at least a portion of the RFID tag.

35. The process of claim 34, wherein the encapsulant is comprised of a thermal-setting polymer or a silicone material.

36. The process of claim 32, further comprising the step of hermetically sealing an end cap to the housing.

37. The process of claim 32, wherein the container further includes a fixation hole for affixing the container to body tissue.

38. The process of claim 32, further comprising the step of affixing an X-ray identification tag to the container.

39. The process of claim 30, wherein the active implantable medical device comprises an active implantable medical device including a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion, or a prosthetic device, and component parts thereof, including lead wires and abandoned lead wires.

40. A process for manufacturing a radio frequency identification device (RFID) for identifying an implant within a patient, comprising the steps of:

associating an RFID tag with an active implantable medical device;

storing information relating to the patient or the active implantable medical device on the RFID tag;

encasing the RFID tag in a biocompatible and hermetically sealed container including a housing and an encapsulant within the housing surrounding at least a portion of the RFID tag; and

implanting the RFID tag in the patient.

41. The process of claim 40, further comprising the step of embedding the RFID tag in a header block of the active implantable medical device.

42. The process of claim 40, wherein the container comprises a housing taken from the group including ceramic, glass, porcelain, sapphire and composites thereof, and specialty polymer composites.

43. The process of claim 42, including a desiccant within the housing.

44. The process of claim 40, wherein the encapsulant is comprised of a thermal-setting polymer or a silicone material.

45. The process of claim 40, further comprising the step of hermetically sealing an end cap to the housing.

46. The process of claim 40, wherein the container further includes a fixation hole for affixing the container to body tissue.

47. The process of claim 40, further comprising the step of affixing an X-ray identification tag to the container.

48. The process of claim 40, wherein the active implantable medical device comprises a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion, or a prosthetic device, and component parts thereof, including lead wires and abandoned lead wires.

49. A process for manufacturing a radio frequency identification device (RFID) for identifying an implant within a patient, comprising the steps of:

providing an active implantable medical device having a header block;

storing information relating to the patient or the active implantable medical device on an RFID tag;

embedding the RFID tag in the header block of the active implantable medical device; and

implanting the active implantable medical device in the patient.

50. The process of claim 49, further comprising the step of associating an X-ray identification tag with the container.

51. The process of claim 49, wherein the active implantable medical device comprises an active implantable medical device including a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, a Bion, or a prosthetic device, and component parts thereof, including lead wires and abandoned lead wires.