Ionizing radiation-protected active implantable medical device

• US 8,694,102 B2
• Filed: 02/07/2012
• Issued: 04/08/2014
• 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.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US13/367,501
• Publication Number:
  US 20120230003A1
• Time in Patent Office: 791 Days
• Field of Search: 607/1, 607 4- 5, 607/116, 600508-528, 361/816
• US Class Current: 607/36
• 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:

a) an AIMD housing;

b) an electronics package including a microprocessor disposed within the AIMD housing, wherein the electronics package has a first external surface area and a remainder external surface area, which first and remainder external surface areas together add up to a total external surface area of the electronics package;

c) a battery disposed within the AIMD housing, the battery being adapted to provide electrical power to the electronics package including the microprocessor, wherein the battery directly faces the first external surface area of the electronics package to thereby shield the first external surface area from ionizing radiation; and

d) a gold shield disposed within the AIMD housing, wherein the gold shield is positioned between the AIMD housing and the remainder external surface area of the electronics package, but not between the battery and the AIMD housing to thereby provide an attenuation of ionizing radiation of at least 0.5 HVL at the remainder external surface area of the electronics package so that the battery together with the gold shield shields the total external surface area of the electronics package.

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

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

4. The medical device of any of claims 1-3, wherein the gold shield comprises a plurality of gold shields.

5. The medical device of claim 4, wherein the plurality of gold shields positioned between the AIMD housing and the remainder external surface area of the electronics package substantially surround the electronics package except for the first external surface area facing the battery.

6. The medical device of claim 1, wherein the gold shield is attached to the electronics package.

7. The medical device of claim 1, wherein the gold shield includes an electrically insulated substrate adjacent to the remainder external surface area of the electronics package, and wherein a high density second shield is positioned adjacent to the electronics package opposite the gold shield.

8. The medical device of any of claims 1-3, wherein the remainder external surface area of the electronics package comprises a plurality of major external surfaces of the electronics package.

9. The medical device of claim 1, wherein the electronics package includes at least one of a circuit board and a substrate, and wherein the gold shield is disposed intermediate the AIMD housing and on or within at least one of the circuit board and the substrate.

10. The medical device of claim 1, wherein the AIMD is selected from the group consisting of 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, and a congestive heart failure device.

11. The medical device of claim 1, wherein the cold shield is a liner contacted to an interior surface of the AIMD housing.

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

13. The medical device of claim 1 wherein the AIMD housing includes an interior recess in which the gold shield is disposed.

14. The medical device of claim 1, wherein the gold shield has a thickness of at least 0.25 millimeters.

15. The medical device of claim 1 wherein the gold shield is co-bonded to a biocompatible substrate disposed within the AIMD housing.

16. The medical device of claim 1 wherein the gold shield has a thickness of from 0.25 millimeters to 1.05 millimeters.

17. The medical device of claim 1 wherein the AIMD housing is of titanium.

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

a) an AIMD housing;

b) an electronics package within the AIMD housing, wherein the electronics package has a first external surface area and a remainder external surface area, which first and remainder external surface areas add up to a total external surface area of the electronics package;

c) a battery disposed within the AIMD housing, the battery being adapted to provide electrical power to the electronics package including the microprocessor, wherein the battery directly faces the first external surface area of the electronics package to thereby shield the first external surface area from ionizing radiation; and

d) an ionizing radiation shield disposed within the AIMD housing and being of a metal selected from the group consisting of gold, platinum, iridium, tungsten and tantalum, wherein the ionizing radiation shield is disposed between the AIMD housing and the remainder external, surface area of the electronics package, but not between the battery and the AIMD housing to thereby provide an attenuation of ionizing radiation of at least 0.5 HVL at the remainder external surface area of the electronics package so that the battery together with the ionizing radiation shield shields the total external surface area of electronics package.

19. The medical device of claim 18, wherein the ionizing radiation shield is adapted to be disposed over an EKG amplifier portion of a CMOS microprocessor comprising the electronics package.

20. The medical device of claim 18, wherein the ionizing radiation shield is a liner contacted to an interior surface of the AIMD housing.

21. The medical device of claim 18 wherein the ionizing radiation shield is plated over a portion of the interior surface of the AIMD housing.

22. The medical device of claim 18 wherein the AIMD housing includes an interior recess in which the ionizing radiation shield is disposed.

23. The medical device of claim 18 wherein the ionizing radiation shield has a thickness of at least 0.25 millimeters.

24. The medical device of claim 18 wherein the ionizing radiation shield comprises a plurality of shields positioned between the AIMD housing and the remainder external surface area of the electronics package to thereby substantially surrounding the electronic package except for the first external surface area facing the battery.

25. The medical device of claim 18 wherein the ionizing radiation shield is attached to the electronics package.

26. The medical device of claim 18 wherein the remainder external surface area of the electronics package comprises a plurality of major surfaces of the electronics package.

27. The medical device of claim 18 wherein the ionizing radiation shield includes an electrically insulated substrate adjacent to the remainder external surface area of the electronics package, and wherein a high density second shield is positioned adjacent to the electronics package opposite the ionizing radiation shield.

28. The medical device of claim 18 wherein the electronics package includes a circuit board, and wherein the ionizing radiation shield is disposed on or within the circuit board.

29. The medical device of claim 18 wherein the AIMD is selected from the group consisting of 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, and a congestive heart failure device.

30. The medical device of claim 18 wherein the ionizing radiation shield is co-bonded to a biocompatible substrate disposed within the AIMD housing.

31. The medical device of claim 18 wherein the ionizing radiation shield has a thickness of from 0.25 millimeters to 1.05 millimeters.

32. The medical device of claim 18 wherein the electronics package within the AIMD housing includes a CMOS microprocessor.

33. The medical device of claim 18 wherein the AIMD housing is of titanium.

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

a) an AIMD housing;

b) an electronics package within the AIMD housing, wherein the electronics package has a first external surface area and a remainder external surface area, which first and remainder external surface areas add up to a total external surface area of the electronics package;

c) a battery disposed within the AIMD housing, the battery being adapted to provide electrical power to the electronics package including the microprocessor, wherein the battery directly faces the first external surface area of the electronics package to thereby shield the first external surface area from ionizing radiation; and

d) a gold shield having a thickness of at least 0.25 millimeters disposed within the AIMD housing, wherein the gold shield is positioned between the AIMD housing and the remainder external surface area of the electronics package, but not between the battery and the AIMD housing to thereby provide a shielded portion at the remainder external surface area of the electronics package so that the battery together with the gold shield shields the total external surface area of the electronics package.

35. The medical device of claim 34, wherein the gold shield is a liner disposed adjacent to an interior surface of the AIMD housing.

36. The medical device of claim 35, wherein the gold shield is plated over a portion of the interior surface of the AIMD housing.

37. The medical device of claim 35 wherein the AIMD housing includes an interior recess in which the gold shield is disposed.

38. The medical device of claim 34, wherein the gold shield comprises a plurality of gold shields substantially surrounding the electronic package except for the first external surface area facing the battery.

39. The medical device of claim 34, wherein the gold shield is attached to the electronics package.

40. The medical device of claim 34 or 39, wherein the remainder external surface area of the electronics package comprises a plurality of major surfaces of the electronics package.

41. The medical device of claim 34, wherein the gold shield includes an electrically insulated substrate adjacent to the remainder external surface area of the electronics package, and wherein a high density second shield is positioned adjacent to the electronics package opposite the gold shield.

42. The medical device of claim 34, wherein the electronics package includes at least one of a circuit board and a substrate, and wherein the gold shield is disposed intermediate the AIMD housing and on or within the at least one of the circuit board and the substrate.

43. The medical device of claim 34, wherein the AIMD is selected from the group consisting of 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, and a congestive heart failure device.

44. The medical device of claim 34 wherein the cold shield is co-bonded to a biocompatible substrate disposed within the AIMD housing.

45. The medical, device of claim 34 wherein the cold shield has a thickness of from 0.25 millimeters to 1.05 millimeters.

46. The medical device of claim 34 wherein the gold shield provides an attenuation of ionizing radiation of at least 0.5 HVL.