Miniature hermetically sealed RFID microelectronic chip connected to a biocompatible RFID antenna for use in conjunction with an AIMD

• US 8,253,555 B2
• Filed: 09/24/2009
• Issued: 08/28/2012
• Est. Priority Date: 01/25/2006
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A., Frysz, Christine A., Kelley, Scott W., Tyers, Geddes Frank Owen
• Primary Examiner(s): CROSLAND, DONNIE L
• Application Number:
  US12/566,223
• Publication Number:
  US 20100060431A1
• Time in Patent Office: 1,069 Days
• Field of Search: 340/539.12, 340/572.1
• US Class Current: 340/539.12
• 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 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• 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

Abstract

A non-hermetically sealed and biocompatible multi-turn RFID loop antenna is electrically connected to a RFID chip which is enclosed within its own hermetically sealed miniature container. The hermetic seal can be very small and the loop antenna can be relatively large, wherein the entire package is both highly reliable, resistant to body fluids and completely biocompatible. The RFID structure can be implanted in a patient and later communicate with an RFID interrogator to provide information relating to the patient and/or implantable medical devices.

Claims

1. An implantable medical device comprising:

a) hermetically sealed biocompatible housing;

b) an RFID microelectronics chip disposed within the housing;

c) an antenna wire having a first end portion electrically connected to a first end of the RFID chip inside the housing and extending along a length to a second end portion electronically connected to a second end of the RFID chip inside the housing with at least an intermediate portion of the length of the antenna wire between the first and second end portions residing outside the housing; and

d) a sealing material that hermetically seals against an outer surface of the first and second end portions of the antenna wire and against respective perimeter openings in the housing through which the antenna wire extends, wherein the intermediate portion of the antenna wire external to the housing serves as an antenna for the RFID microelectronics chip.

2. The implantable medical device of claim 1, wherein the housing has a leak rate of no more than 10⁻

7 centimeters per second.

3. The implantable medical device of claim 2, wherein the housing is of a material selected from the group consisting of biocompatible metals and alloys, ceramic, glass, porcelain, sapphire and composites thereof, and specialty polymer composites.

4. The implantable medical device of claim 3, including a desiccant within the housing.

5. The implantable medical device of claim 3, including an encapsulant within the housing surrounding at least a portion of the RFID chip.

6. The implantable medical device of claim 5, wherein the encapsulant is comprised of a thermal-setting polymer or a silicone material.

7. The implantable medical device of claim 1, wherein the housing includes a cap hermetically sealed to an open end of a housing container.

8. The implantable medical device of claim 1, wherein the RFID chip is read-only or readable/writable.

9. The implantable medical device of claim 1, wherein the RFID chip is communicable with an external device at a radio frequency of from 125 kHz to 915 MHz.

10. The implantable medical device of claim 9, wherein the RFID chip is communicable with an external device at a radio frequency of approximately 13.56 MHz.

11. The implantable medical device of claim 1, wherein the RFID chip includes information relating to a patient in which the medical device is implanted.

12. The implantable medical device of claim 1, wherein the container, RFID chip, and at least the first and second end portions of the antenna wire are embedded within a non-conductive biocompatible material.

13. The implantable medical device of claim 12, wherein the biocompatible material comprises a disc of a material selected from the group consisting of silicone, epoxy, and a medical grade plastic.

14. The implantable medical device of claim 1, wherein the intermediate portion of the antenna wire is wound around a ferrite-based core.

15. The implantable medical device of claim 14, wherein the ferrite-based core comprises a high temperature sintered ferrite-based material.

16. The implantable medical device of claim 15, including a biocompatible dielectric material at least partially coating the ferrite-based material.

17. The implantable medical device of claim 16, wherein the biocompatible dielectric material is selected from the group consisting of parylene, ETFE, PTFE, polyimide, polyurethane, and silicone.

18. The implantable medical device of claim 14, wherein the ferrite-based core is comprised of a ferrite material that will not exhibit permanent remanence after exposure to MRI fields.

19. The implantable medical device of claim 1, including a sensor conductively coupled to the RFID microelectronics chip.

20. The implantable medical device of claim 19, wherein the sensor is disposed exterior of the hermetically sealed housing.

21. The implantable medical device of claim 19, wherein the sensor is disposed within the hermetically sealed housing.

22. The implantable medical device of claim 19, wherein the RFID chip is capable of transmitting data measured by the sensor in real time.

23. The implantable medical device of claim 22, wherein the measurable data comprises the activity of a human body.

24. The implantable medical device of claim 1 wherein the intermediate portion of the antenna wire is a multi-turn antenna.

25. The implantable medical device of claim 1 wherein the first and second end portions of the antenna wire are first and second feedthrough wires that are hermetically sealed in the respective openings in the housing and opposed end of the intermediate portion of the antenna wire are electrically connected to the first and second feedthrough wires.

26. The implantable medical device of claim 1 wherein the hermetically sealed housing is the housing for an active implantable medical device.

27. The implantable medical device of claim 1 wherein the hermetically sealed housing s of titanium or stainless steel.

31. The system of claim 3 including an interrogator for electromagnetically communicating with the RFID chip.

32. The system of claim 31 wherein the interrogator is a read only or a reader/writer device.

33. The system of claim 31 wherein the interrogator is capable of communicating with a computer or a computer network.

28. An implantable medical device, comprising:

a) a hermetically sealed biocompatible housing;

b) an RFID microelectronics chip disposed within the housing;

c) an antenna wire having a first end portion electrically connected to a first end of the RFID chip inside the housing and extending along a length to a second end portion electronically connected to a second end of the RFID chip inside the housing with at least an intermediate portion of the length of the antenna wire between the first and second end portions residing outside the housing; and

d) wherein a wall of the housing hermetically seals against an outer surface of the first and second end portions of the antenna wire, wherein the intermediate portion of the antenna wire external to the housing serves as an antenna for the RFID microelectronics chip.

29. An implantable medical device, comprising:

a) a hermetically sealed biocompatible housing;

b) an RFID microelectronics chip disposed within the housing;

c) a first feedthrough wire comprising a first proximal end electrically connected to the RFID chip and a first distal end residing outside the hermetically sealed housing, wherein a first sealing material hermetically seals against an outer surface of the first feedthrough wire and against a first perimeter opening in the housing through which the first feedthrough wire extends;

d) a second feedthrough wire comprising a second proximal end electrically connected to the RFID chip and a second distal end residing outside the hermetically sealed housing, wherein a second sealing material hermetically seals against an outer surface of the second feedthrough wire and against a second perimeter opening in the housing through which the second feedthrough wire extends; and

e) an antenna wire having a first end electrically connected to the first distal end of the first feedthrough wire outside the housing and extending along a length to a second end electronically connected to the second distal end of the second feedthrough wire outside the housing.

30. A medical system comprising:

a) an implantable medical device;

b) a hermetically sealed biocompatible housing that is either contained inside the implantable medical device or contacted to an outer surface thereof;

c) an RFID microelectronics chip disposed within the housing;

d) an antenna wire having a first end portion electrically connected to a first end of the RFID chip inside the housing and extending along a length to a second end portion electronically connected to a second end of the RFID chip inside the housing with at least an intermediate portion of the length of the antenna wire between the first and second end portions residing outside the housing; and

e) a sealing material that hermetically seals against an outer surface of the first and second end portions of the antenna wire and against respective perimeter openings in the housing through which the antenna wire extends, wherein the intermediate portion of the antenna wire external to the housing serves as an antenna for the RFID microelectronics chip.

34. The system of claim 30 wherein the hermetically sealed housing for the RFID chip is disposed within a non hermetically sealed portion of the medical device.

35. The system of claim 30 wherein the hermetically sealed housing for the RFID chip is disposed within a header block of the medical device.

36. The system of claim 30 wherein the antenna wire and the RFID chip are disposed within the medical device parallel to a length and height plane of the medical device, and midway through the width thereof.

37. The system of claim 30 wherein the RFID chip includes information pertaining to the medical device.

38. The system of claim 30 wherein the implantable medical device is selected from the group consisting of 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 wire.