IONIZING RADIATION-PROTECTED ACTIVE IMPLANTABLE MEDICAL DEVICE

• US 20120230003A1
• Filed: 02/07/2012
• Published: 09/13/2012
• Est. Priority Date: 03/09/2011
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Ryan A., Stevenson, Robert A.
• Granted Patent: US 8,694,102 B2
• Time in Patent Office: Days
• US Class Current: 361/816
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: G21F 1/085 Heavy metals or alloys
• CPC Class Codes: G21F 3/00 Shielding characterised by its physical form, e.g. granules, or shape of the material

Abstract

A radiation protected active implantable medical device includes an ionizing radiation shield disposed over at least one major surface of an electronics package, a microprocessor, or both contained within an AIMD housing. The ionizing radiation shield is made from a high atomic number, high atomic weight, high density material such as led, gold, platinum, iridium, tungsten or tantalum and has an atomic weight of at least 180 and a density of at least 11 grams per cubic centimeter. The ionizing radiation shield has a thickness of at least 0.25 millimeters and is preferably no thicker than 1.05 millimeters and has an overall attenuation of ionizing radiation of at least 0.5 HVL.

Claims

1. An ionizing radiation-protected active implantable medical device (AIMD), comprising:

an AIMD housing;

an electronics package within the AIMD housing, the electronics package including a microprocessor; and

an ionizing radiation shield disposed over at least one major surface of the electronics package, the microprocessor, a portion of the microprocessor, or any combination thereof.

2. The medical device of claim 1, wherein the microprocessor includes CMOS circuits.

3. The medical device of claim 2, wherein the shielded portion of the microprocessor comprises an EKG amplifier portion of a CMOS microprocessor.

4. The medical device of any of claims 1-3, wherein the ionizing radiation shield includes a plurality of shields.

5. The medical device of claim 4, wherein the plurality of shields substantially surround the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof.

6. The medical device of claim 1, wherein the ionizing radiation shield is attached to the electronics package, the microprocessor, or both.

7. The medical device of claim 1, wherein the ionizing radiation shield includes an electrically insulated substrate adjacent to the electronics package, the microprocessor, or both, and a high density shield material opposite the electronics package, the microprocessor, or both, relative to the electrically insulated substrate.

8. The medical device of any of claims 1-3, wherein the ionizing radiation shield is disposed over a plurality of major surfaces of the electronics package, the microprocessor, or both.

9. The medical device of claim 1, wherein the electronics package includes a circuit board or substrate, and wherein the ionizing radiation shield is disposed on or within the circuit board or substrate.

10. The medical device of claim 1, wherein the AIMD comprises a cochlear implant, a piezoelectric sound bridge transducer, a neurostimulator, a brain stimulator, a cardiac pacemaker, a left ventricular assist device, an artificial heart, a drug pump, a bone growth stimulator, a urinary incontinence device, a pain relief spinal cord stimulator, an anti-tremor stimulator, an implantable cardioverter defibrillator, or a congestive heart failure device.

11. The medical device of claim 1, wherein the ionizing radiation shield comprises a high density liner adjacent to an interior surface of the AIMD housing.

12. The medical device of claim 11, wherein the housing liner is plated over a substantial portion of the interior surface of the AIMD housing.

13. The medical device of claim 11, wherein the ionizing radiation shield is disposed over a limited portion of the interior surface of the AIMD housing immediately adjacent to the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof.

14. The medical device of claim 13, wherein the AIMD housing includes an interior recess in which the ionizing radiation shield is disposed.

15. The medical device of claim 1, wherein the ionizing radiation shield has a thickness of at least 0.25 millimeters.

16. The medical device of claim 1, wherein the AIMD housing includes a high atomic number insert adjacent to the electronics package, the microprocessor, or both, the insert forming the ionizing radiation shield.

17. The medical device of claim 15, wherein the insert comprises a biocompatible substrate and a high atomic number and high density shield material co-bonded to the substrate and disposed within the AIMD housing.

18. The medical device of claim 15, wherein the ionizing radiation shield is comprised of material selected from the group consisting of lead, gold, platinum, iridium, tungsten and tantalum.

19. The medical device of claim 18, wherein the ionizing radiation shield has a thickness of between 0.25 millimeters and 1.05 millimeters.

20. The medical device of claim 1, wherein the ionizing radiation shield has an overall attenuation of ionizing radiation of at least 0.5 HVL.

21. The medical device of claim 1, wherein the ionizing radiation shield has an atomic weight of at least 180 and a density of at least 11 grams per cubic centimeter.

32. The medical device of claim 21, wherein the ionizing radiation shield is attached to the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof.

22. An ionizing radiation-protected active implantable medical device (AIMD) comprising:

an AIMD housing;

an electronics package within the AIMD housing, the electronics package including;

a CMOS microprocessor; and

an ionizing radiation shield disposed over at least one major surface of the electronics package, the microprocessor, a portion of the microprocessor, or any combination thereof, wherein the ionizing radiation shield has an atomic weight of at least 180.

23. The medical device of claim 22, wherein the ionizing radiation shield is disposed over an EKG amplifier portion of the CMOS microprocessor.

24. The medical device of claim 22, wherein the ionizing radiation shield comprises a high density liner adjacent to an interior surface of the AIMD housing.

25. The medical device of claim 24, wherein the housing liner is plated over a substantial portion of the interior surface of the AIMD housing.

26. The medical device of claim 24, wherein the ionizing radiation shield is disposed over a limited portion of the interior surface of the AIMD housing immediately adjacent to the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof.

27. The medical device of claim 24, wherein the AIMD housing includes an interior recess in which the ionizing radiation shield is disposed.

28. The medical device of claim 24, wherein the ionizing radiation shield has a density of at least 11 grams per cubic centimeter.

29. The medical device of claim 23 or 28, wherein the ionizing radiation shield has a thickness of at least 0.25 millimeters.

30. The medical device of claim 28, wherein the ionizing radiation shield has an overall attenuation of at least 0.5 HVL.

31. The medical device of claim 23, wherein the ionizing radiation shield includes a plurality of shields surrounding the electronic package, the microprocessor, or both.

33. The medical device of claim 23 or 32, wherein the ionizing radiation shield is disposed over a plurality of major surfaces of the electronics package, the microprocessor, or both.

34. The medical device of claim 23, wherein the ionizing radiation shield includes an electrically insulated substrate adjacent to the electronics package, the microprocessor, or both, and a high density shield material opposite the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof, relative to the electrically insulated substrate.

35. The medical device of claim 23, wherein the electronics package includes a circuit board, and wherein the ionizing radiation shield is disposed on or within the circuit board.

36. The medical device of claim 23, wherein the AIMD comprises a cochlear implant, a piezoelectric sound bridge transducer, a neurostimulator, a brain stimulator, a cardiac pacemaker, a left ventricular assist device, an artificial heart, a drug pump, a bone growth stimulator, a urinary incontinence device, a pain relief spinal cord stimulator, an anti-tremor stimulator, an implantable cardioverter defibrillator, or a congestive heart failure device.

37. The medical device of claim 23, wherein the AIMD housing includes a high atomic number insert adjacent to the electronics package, the microprocessor, the portion of the microprocessor, or any combination thereof, the insert forming the ionizing radiation shield.

38. The medical device of claim 37, wherein the insert comprises a biocompatible substrate and a high atomic number and high density shield material co-bonded to the substrate and disposed within the AIMD housing.

39. The medical device of claim 23, wherein the ionizing radiation shield is comprised of material selected from the group consisting of lead, gold, platinum, iridium, tungsten and tantalum.

40. The medical device of claim 39, wherein the ionizing radiation shield is comprised of gold and has a thickness of between 0.25 millimeters and 1.05 millimeters.

41. An ionizing radiation-protected active implantable medical device (AIMD) comprising:

an AIMD housing;

an electronics package within the AIMD housing; and

an ionizing radiation shield disposed over at least one major surface of the electronics package, wherein the ionizing radiation shield has a density of at least 11 grams per cubic centimeter.

42. The medical device of claim 41, wherein the ionizing radiation shield comprises a high density liner adjacent to an interior surface of the AIMD housing.

43. The medical device of claim 42, wherein the housing liner is plated over a substantial portion of the interior surface of the AIMD housing.

44. The medical device of claim 42, wherein the ionizing radiation shield is disposed over a limited portion of the interior surface of the AIMD housing immediately adjacent to the electronics package, or a portion of the electronics package.

45. The medical device of claim 42, wherein the AIMD housing includes an interior recess in which the ionizing radiation shield is disposed.

46. The medical device of claim 42, wherein the ionizing radiation shield has an atomic weight of at least 180.

47. The medical device of claim 41 or 46, wherein the ionizing radiation shield has a thickness of at least 0.25 millimeters.

48. The medical device of claim 46, wherein the ionizing radiation shield has an overall attenuation of at least 0.5 HVL.

49. The medical device of claim 41, wherein the ionizing radiation shield includes a plurality of shields surrounding the electronic package, or a portion of the electronics package.

50. The medical device of claim 41, wherein the ionizing radiation shield is attached to the electronics package, or a portion of the electronics package.

51. The medical device of claim 41 or 50, wherein the ionizing radiation shield is disposed over a plurality of major surfaces of the electronics package, or a portion of the electronics package.

52. The medical device of claim 41, wherein the ionizing radiation shield includes an electrically insulated substrate adjacent to the electronics package, or a portion of the electronics package, and a high density shield material opposite the electronics package, or a portion of the electronics package, relative to the electrically insulated substrate.

53. The medical device of claim 41, wherein the electronics package includes a circuit board or substrate, and wherein the ionizing radiation shield is disposed on or within the circuit board or substrate.

54. The medical device of claim 41, wherein the AIMD comprises a cochlear implant, a piezoelectric sound bridge transducer, a neurostimulator, a brain stimulator, a cardiac pacemaker, a left ventricular assist device, an artificial heart, a drug pump, a bone growth stimulator, a urinary incontinence device, a pain relief spinal cord stimulator, an anti-tremor stimulator, an implantable cardioverter defibrillator, or a congestive heart failure device.

55. The medical device of claim 41, wherein the AIMD housing includes a high atomic number insert adjacent to the electronics package, or a portion of the electronics package, the insert forming the ionizing radiation shield.

56. The medical device of claim 55, wherein the insert comprises a biocompatible substrate and a high atomic number and high density shield material co-bonded to the substrate and disposed within the AIMD housing.

57. The medical device of claim 41, wherein the ionizing radiation shield is comprised of material selected from the group consisting of lead, gold, platinum, iridium, tungsten and tantalum.

58. The medical device of claim 57, wherein the ionizing radiation shield is comprised of gold and has a thickness of between 0.25 millimeters and 1.05 millimeters.