Ultra-thin hermetic enclosure for implantable medical devices

• US 5,876,424 A
• Filed: 01/23/1997
• Issued: 03/02/1999
• Est. Priority Date: 01/23/1997
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Oleen, Farrell, O'Phelan, Michael J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/787,640
• Time in Patent Office: 768 Days
• Field of Search: 607/36, 607/2, 607/9
• US Class Current: 607/36
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing

Abstract

An implantable medical device and method of making the same. The device includes an electronic component sub-assembly with an exterior surface. A plurality of electronic components are disposed spaced apart and internal to the external surface. The components define voids between one another. The voids are filled with an electrically insulative material which is substantially rigid. An ultra-thin hermetic shell is then formed over the exterior surface of the implantable medical device.

Claims

1. An implantable medical device, comprising:

a component sub-assembly including an insert made of an electrically insulative material and a plurality of electronic components wherein the plurality of electronic components are attached to the insert; and

a thin metal hermetic shell adapted to receive and encapsulate the component subassembly, the tin hermetic shell having a thickness of 0.012 inches or less,

wherein the insert and one or more of the plurality of electronic components are configured so as to define an outer surface which conforms to an inner surface of the thin hermetic shell and which provides support for the thin hermetic shell.

2. The implantable medical device of claim 1, wherein said thin hermetic shell comprises a bio-compatible material.

3. The implantable medical device of claim 2 wherein said bio-compatible material comprises titanium or stainless steel.

4. The implantable medical device of claim 3, wherein said thin hermetic shell has a thickness of 0.005 inches or less.

5. The implantable medical device of claim 3, wherein said thin hermetic shell comprises a plated layer over the component sub-assembly.

6. The implantable medical device of claim 5, wherein said thin hermetic shell has a thickness of 0.002 inches or less.

7. The implantable medical device of claim 1, wherein the insert is an injection molded thermoplastic.

8. The implantable medical device of claim 1, wherein said insert is a preformed thermoplastic injection molded insert having a contour to adapt to support each of said plurality of electronic components.

9. A method of producing an implantable medical device, said method comprising:

forming a component sub-assembly including an insert of electrically insulative material and a plurality of electronic components;

placing said plurality of electronic components in a mold cavity;

injecting a heated electrically insulative thermoplastic material around the plurality of electronic components within the mold cavity to form the component sub-assembly; and

removing the component sub-assembly from the mold cavity when the thermoplastic material is sufficiently cooled;

encapsulating said component assembly in a thin hermetic shell; and

where the insert and one or more of the plurality of electronic components define an outer surface of the component sub-assembly which conforms to an inner surface of the thin hermetic shell to provide support for the thin hermetic shell encapsulating the component sub-assembly.

10. A method of producing an implantable medical device, said method comprising:

forming a component sub-assembly including an insert of electrically insullative material and a plurality of electronic components, where the insert and one or more of the plurality of electronic components define an outer surface of the component sub-assembly which conforms to an inner surface of a thin hermetic shell to provide support for the thin hermetic shell encapsulating the component sub-assembly; and

plating said component sub-assembly with a layer of bio-compatible material to form said thin hermetic shell.

11. A method of producing an implantable medical device, said method comprising:

forming a component sub-assembly including an insert of electrically insulative material and a plurality of electronic components, where the insert and one or more of the plurality of electronic components define an outer surface of the component sub-assembly which conforms to an inner surface of a thin hermetic shell to provide support for the thin hermetic shell encapsulating the component sub-assembly; and

placing said component sub-assembly within a prefabricated hermetic casing and laser welding said prefabricated hermetic casing to form said thin hermetic shell.