Packaging technology for non-transvenous cardioverter/defibrillator devices

• US 20020107546A1
• Filed: 11/05/2001
• Published: 08/08/2002
• Est. Priority Date: 09/18/2000
• Status: Active Grant

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Ostroff, Alan H., Rissmann, William J.
• Granted Patent: US 7,194,309 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

Packaging techniques for a non-transvenous implantable cardioverter/defibrillator include a housing and a frame within the housing for holding electronic components. A header is disposed on the housing and includes at least one feedthrough extending through the housing for providing electrical communication to and from the electronic components within the housing.

Claims

1. A subcutaneous implantable cardioverter/defibrillator comprising:

a housing having an inner surface and an outer surface;

a frame disposed on the inner surface of the housing;

a power circuit electrically coupled to the frame;

an electronic package disposed on a substrate electrically coupled to the frame and to the power circuit; and

a header fixed on a portion of the outer surface of the housing wherein the header comprises at least one feedthrough extending through the housing to allow electrical communication to and from the electronic package within the housing.

2. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the housing further comprises a first half and a second half adapted to fit each other.

3. The subcutaneous implantable cardioverter/defibrillator of claim 2, wherein the first half and the second half of the housing are welded together.

4. The subcutaneous implantable cardioverter/defibrillator of claim 3, wherein the housing is backfilled with gas to prevent potential arching inside the housing.

5. The subcutaneous implantable cardioverter/defibrillator of claim 3, wherein the gas further comprises approximately 90-95% Nitrogen gas.

6. The subcutaneous implantable cardioverter/defibrillator of claim 3, wherein the gas further comprises approximately 5 to 10% Helium.

7. The subcutaneous implantable cardioverter/defibrillator of claim 3, wherein the housing further comprises dead spaces filled with a dissecant.

8. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the housing further comprises a material selected from the group consisting essentially of ceramics, titanium, stainless steel, and Nickel alloys.

9. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the frame further comprises a plastic material.

10. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the frame further comprises a self-supporting flex circuit.

11. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the header further comprises materials selected from the group consisting essentially of polyurethane, silicone and epoxy.

12. The subcutaneous implantable cardioverter/defibrillator of claim 1 further comprising a connector block embedded in the header adapted to connect a lead and making an attachment to the at least one feedthrough.

13. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the at least one feedthrough further comprises a hermetic wire.

14. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the at least one feedthrough further comprises at least one of plastic insulation, ceramics and glass.

15. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the header further comprises a pre-slit septum covered hole adapted to be punctured with a tool, the septum covered hole positioned to receive a lead.

16. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the electronic package further comprises at least one integrated circuit.

17. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the electronic package further comprises surface mounted components.

18. The subcutaneous implantable cardioverter/defibrillator of claim 17 wherein the surface mounted components further comprise capacitors.

19. The subcutaneous implantable cardioverter/defibrillator of claim 17 wherein the surface mounted components further comprise resistors.

20. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the power circuit further comprises at least one battery.

21. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the power circuit further comprises at least one high-voltage capacitor.

22. The subcutaneous implantable cardioverter/defibrillator of claim 1 further comprising an insulator positioned between the inner surface of the housing and the electronic package and the power circuit.

23. The subcutaneous implantable cardioverter/defibrillator of claim 22 wherein the insulator further comprises a material selected from the group consisting essentially of polycarbonate, polyimide, and parylene.

24. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the substrate further comprises a material selected from the group consisting essentially of a high-temperature co-fired ceramic, a low-temperature co-fired ceramic, an epoxy and a polyimide.

25. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the electronic package further comprises a bare chip.

26. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the electronic package further comprises an encapsulated chip.

27. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the substrate further comprises a cavity sized to receive an electronic component of the electronic package.

28. The subcutaneous implantable cardioverter/defibrillator of claim 27 wherein the electronic component is mounted near a bottom of the cavity.

29. The subcutaneous implantable cardioverter/defibrillator of claim 27, wherein the electronic component further comprises a bare chip.

30. The subcutaneous implantable cardioverter/defibrillator of claim 27, wherein the electronic component further comprises an encapsulated chip with glob-top.

31. The subcutaneous implantable cardioverter/defibrillator of claim 27, wherein the electronic component further comprises a ball grid array.

32. The subcutaneous implantable cardioverter/defibrillator of claim 27, wherein the electronic component further comprises a leadless chip carrier.

33. The subcutaneous implantable cardioverter/defibrillator of claim 27, wherein the electronic component further comprises flip chip technology.

34. The subcutaneous implantable cardioverter/defibrillator of claim 27 wherein the cavity is filled with an encapsulant to cover the electronic component.

35. The subcutaneous implantable cardioverter/defibrillator of claim 29 wherein the bare chip is mounted with wire bonds from top of the bare chip to metallization on the substrate.

36. The subcutaneous implantable cardioverter/defibrillator of claim 27 further comprising a lid placed on top of the cavity.

37. The subcutaneous implantable cardioverter/defibrillator of claim 36 wherein the lid further comprises kovar material.

38. The subcutaneous implantable cardioverter/defibrillator of claim 29 wherein the bare chip is glob-topped.

39. The subcutaneous implantable cardioverter/defibrillator of claim 27 further comprising at least one extra layer of substrate applied on top of the cavity.

40. The subcutaneous implantable cardioverter/defibrillator of claim 39 further comprising electronic components mounted on the at least one extra layer of substrate.

41. The subcutaneous implantable cardioverter/defibrillator of claim 39 wherein the electronic components are mounted on the at least one extra layer of substrate by using a ball grid array.

42. The subcutaneous implantable cardioverter/defibrillator of claim 39 wherein the electronic components are mounted on the at least one extra layer of substrate by using a wire bond.

43. The subcutaneous implantable cardioverter/defibrillator of claim 39 wherein the electronic components are mounted on the at least one extra layer of substrate by using a wire bond with glob top.

44. The subcutaneous implantable cardioverter/defibrillator of claim 39 wherein the electronic components are mounted on the at least one extra layer of substrate by using a leadless chip carrier.

45. The subcutaneous implantable cardioverter/defibrillator of claim 39 wherein the electronic components are mounted on the at least one extra layer of substrate by using flip chip technology.

46. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the substrate has a lower surface and an upper surface.

47. The subcutaneous implantable cardioverter/defibrillator of claim 46 wherein the electronic package further comprises electronic components disposed on at least one of the lower surface and the upper surface of the substrate.

48. The subcutaneous implantable cardioverter/defibrillator of claim 46 wherein the lower surface and the upper surface of the substrate further comprise at least one cavity.

49. The subcutaneous implantable cardioverter/defibrillator of claim 1 further comprising a flexible circuit to interconnect the electronic package, the power circuit, and the at least one feedthrough.

50. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the power circuit is interconnected to the electronic package by discrete wires.

51. The subcutaneous implantable cardioverter/defibrillator of claim 1 wherein the power circuit is interconnected to the electronic package by discrete wires.

52. A method for packaging a subcutaneous implantable cardioverter/defibrillator comprising the steps of:

providing a housing having an inner surface and an outer surface;

placing a frame on the inner surface of the housing;

using the frame to hold a power source, a power storage circuit and an electronic package on a substrate within the housing;

interconnecting the power source, the power storage circuit and the electronic package to the frame;

fitting a header along a portion of the outer surface of the housing, the header having a connector block embedded therein;

connecting the electronic package to a feedthrough, which is in turn connected to the connector block;

providing a septum covered hole in the header adapted to receive a lead; and

tightening the lead into the septum covered hole by using a tool.

53. The method of claim 52 further comprising the step of puncturing the septum covered hole for receiving the lead.

54. The method of claim 52, further comprising the step of forming the housing by attaching a first half to a second half adapted to fit each other.

55. The method of claim 52, further comprising the step of applying an insulator between the inner surface of the housing and the electronic package.

56. The method of claim 54 further comprising the step of welding the first half to the second half to form the housing.

57. The method of claim 56, further comprising applying an insulator between the inner surface of the housing and the electronic package before welding the first half to the second half of the housing.

58. The method of claim 56 further comprising the step of backfilling the housing with a gas to reduce arching inside the housing.

59. The method of claim 58 wherein the gas further comprises approximately 90-95% Nitrogen gas.

60. The method of claim 58 wherein the gas further comprises approximately 5 to 10% Helium.

61. The method of claim 52 further comprising the step of filling dead spaces in the housing with a dissecant.

62. The method of claim 52, further comprising mounting an electronic component of the electronic package in a cavity of the substrate.

63. The method of claim 62 further comprising mounting the electronic component using a ball grid array.

64. The method of claim 62 further comprising mounting the electronic component using a leadless chip carrier.

65. The method of claim 62 further comprising mounting the electronic component using a flip chip technology.

66. The method of claim 62, further comprising filling the cavity with an encapsulant to cover the electronic component.

67. The method of claim 62, wherein the electronic component further comprises a bare chip.

68. The method of claim 67, further comprising mounting the bare chip in the cavity by using at least one wire bond.

69. The method of claim 67, further comprising providing a cavity lid to protect the bare chip.

70. The method of claim 62, wherein the electronic component further comprises an encapsulated chip.

71. The method of claim 70, further comprising using glob-top to embed the encapsulated chip in the cavity.

72. The method of claim 62, further comprising the step of applying at least one extra layer of substrate on top of the cavity once the electronic components in the cavity are mounted.

73. The method of claim 72, further comprising the step of placing additional electronic components on top of the extra layers of substrate.

74. The method of claim 73, further comprising the step of using a ball grid array technique to place the additional electronic components on the extra layers of substrate.

75. The method of claim 73, further comprising the step of using a leadless chip carrier to place the additional electronic components on the extra layers of substrate.

76. The method of claim 73, further comprising the step of using flip chip technology to place the additional electronic components on the extra layers of substrate.

77. The method of claim 52 wherein the step of interconnecting further comprises using a flex circuit.

78. The method of claim 52 wherein the step of interconnecting further comprises using discrete wires.

80. The non-transvenous implantable cardioverter/defibrillator of claim 79, wherein the frame further comprises a self-supporting flex circuit for holding the electronic components.

81. The non-transvenous implantable cardioverter/defibrillator of claim 79, wherein the flex circuit further comprises solder to hold the electronic components.

79. A non-transvenous implantable cardioverter/defibrillator comprising:

a housing;

a frame within the housing for holding electronic components; and

a header disposed on the housing comprising at least one feedthrough extending through the housing for providing electrical communication to and from the electronic components within the housing.