Implanted ceramic case with enhanced ceramic case strength

• US 6,411,854 B1
• Filed: 07/14/1999
• Issued: 06/25/2002
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Tziviskos, George, Law, Tom J., Mann, Alfred E.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/353,237
• Time in Patent Office: 1,077 Days
• Field of Search: 607/1, 607/2, 607/36-38, 607/55-57
• US Class Current: 607/57
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

An implantable medical device is made from an electronic subassembly hermetically sealed in a ceramic case filled with a potting material. Use of the potting material enhances the capacity of the device to withstand mechanical shock without failure. The device includes a hollow ceramic or other case having an open end to which a metal ring is hermetically bonded. The inside surface of the ceramic case is treated (cleansed and activated) to assure the potting material adheres to it. The potting material, while in a non-cured fluid or quasi-fluid state, is inserted inside of the ceramic case. The electronic circuitry is next inserted into the open end of the ceramic case while the potting material is still in a non-cured, soft or fluid state. The electronic circuitry displaces some of the potting material and the potting material fills the voids between the electronic circuitry and the ceramic case. The potting material is then slowly cured, and once cured, supports the walls of the ceramic case and protects the electronic circuitry embedded therein. A header (to which the electronic circuitry is attached) is hermetically bonded to the metal band on the open end of the ceramic case, thereby hermetically sealing the implantable device.

Claims

1. An implantable medical device comprising a case having walls with an open end, and components housed within the case, wherein the components are configured to carry out a desired function, the medical device further comprising:

a cavity within the case;

a potting material within the cavity and essentially filling the cavity;

a substrate assembly embedded within the potting material within the cavity, the substrate assembly carrying the components of the device; and

a header attached to the substrate assembly that hermetically closes the open end of the case;

wherein the potting material supports the walls of the case and helps prevent the walls from collapsing under a mechanical stress or impact load; and

wherein the potting material comprises a curable potting material that cures at an elevated temperature >

100°

C.

2. The implantable medical device of claim 1 wherein the potting material comprises a rigid potting material.

3. The implantable medical device of claim 1 wherein the potting material is selected from the group consisting of urethane, urethane foam, silicone, epoxy, Al₂O₃-filled epoxy, and epoxy mixed with at least one benign material.

4. The implantable medical device of claim 1 wherein the case is made from a ceramic material.

5. The implantable medical device of claim 4 further including a closed metal band hermetically bonded to the open end of the ceramic case;

and wherein the header is hermetically bonded to the band, thereby hermetically closing the ceramic case.

6. The implantable medical device of claim 5 wherein the metal band comprises a metal selected from the group consisting of niobium, molybdenum and tantalum.

7. The implantable medical device of claim 4 wherein the ceramic case comprises an inert ceramic selected from the group consisting of aluminum oxide and zirconium oxide.

8. The implantable medical device of claim 1 wherein the potting material is selected from the group consisting of HYSOL FP4651 and HYSOL FP4651 mixed with at least one benign material.

9. An implantable medical device comprising:

(a) a ceramic case made from a ceramic material, the ceramic case having walls and an open end that defines a cavity, wherein the cavity is accessible through the open end, and wherein the ceramic material has a first coefficient of thermal expansion (CTE);

(b) device components within the cavity;

(c) a potting material within the cavity essentially filling voids within the cavity between the device components and the walls of the ceramic case, wherein the potting material comprises a curable potting material that cures at an elevated temperature >

100°

C.;

(d) a closed metal band bonded to the open end of the ceramic case, wherein the band is formed from a metal having a second CTE substantially the same as the first CTE of the ceramic material; and

(e) a header hermetically bonded to the metal band, wherein the header seals the open end of the ceramic case and hermetically seals the implantable medical device.

10. The implantable medical device of claim 9 wherein the potting material is selected from the group consisting of urethane, urethane foam, silicone, epoxy, Al₂O₃-filled epoxy, and epoxy filled with at least one benign material.

11. The implantable medical device of claim 10 wherein the ceramic material comprises an inert ceramic selected from the group consisting of aluminium oxide and zirconium oxide, and wherein the metal band comprises a metal selected from the group consisting of niobium, molybdenum, tantalum, and the alloys of niobium, molybdenum and tantalum.

12. The implantable medical device of claim 9 wherein the potting material is selected from the group consisting of HYSOL FP4651 and HYSOL FP4651 mixed with at least one benign material.

13. An implantable cochlear stimulator (ICS) comprising a ceramic case having walls with an open end, and components housed within the ceramic case, wherein the components receive control signals, and wherein the components generate electrical stimuli for stimulating an auditory nerve of a patient in response to the control signals, the ICS further comprising:

a cavity within the ceramic case;

a potting material within the cavity and essentially filling the cavity;

a substrate assembly embedded within the potting material within the cavity, wherein the substrate assembly has components of the device mounted thereon; and

a header attached to the substrate assembly that hermetically closes the open end of the case;

wherein the potting material supports the walls of the case and helps prevent the walls from collapsing under a mechanical stress or impact load; and

wherein the potting material comprises a curable potting material that cures at an elevated temperature >

100°

C.

14. The ICS of claim 13 wherein the potting material is selected from the group consisting of urethane, urethane foam, silicone, epoxy, Al₂O₃-filled epoxy, and epoxy filled with at least one benign material.

15. The ICS of claim 14 further including a metal band hermetically attached to the ceramic case and the header.

16. The ICS of claim 15 wherein the ceramic case comprises an inert ceramic selected from the group consisting of aluminum oxide and zirconium oxide, and wherein the metal band comprises a metal selected from the group consisting of niobium, molybdenum, tantalum, and the alloys of niobium, molybdenum and tantalum.

17. The implantable medical device of claim 13 wherein the potting material is selected from the group consisting of HYSOL FP4651 and HYSOL FP4651 mixed with at least one benign material.