Sealing of an implantable medical device

• US 8,412,304 B2
• Filed: 07/02/2010
• Issued: 04/02/2013
• Est. Priority Date: 07/16/2009
• Status: Active Grant

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Kara, Sule, Svehla, Martin, Capcelea, Edmond
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/830,036
• Publication Number:
  US 20110015686A1
• Time in Patent Office: 1,005 Days
• Field of Search: 607/2, 607/36, 607/116, 600/395, 430/320
• US Class Current: 600/395
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

A method of adhering a protective layer applied to a substrate region of an implantable medical device (IMD) to form a covered substrate region. The method includes obtaining the IMD, depositing an intermediate layer on a portion of the substrate region of the IMD such that the intermediate layer binds to the portion of the substrate region to create a modified substrate region, and depositing the protective layer after depositing the intermediate layer onto the intermediate layer and adhering the protective layer to the intermediate layer. In an embodiment of the present invention, this method enhances the sealing characteristics of the protective layer by, for example, reducing the likelihood of delamination of the protective layer from the IMD relative to IMDs prepared by certain other methods.

Claims

1. A method of adhering a protective layer to a substrate region of an implantable medical device (IMD) to form a covered substrate region, comprising:

depositing an intermediate layer on a portion of the substrate region such that the intermediate layer binds to the portion of the substrate region to create a modified substrate region comprising the covered substrate region and a boundary region;

depositing a protective layer onto at least the intermediate layer along the covered substrate region but not along the boundary region; and

adhering the protective layer to the intermediate layer along only the covered substrate region such that an increased adhesion exists between the protective layer and the covered substrate region relative to adhesion that would be present between the portion of the substrate region and the protective layer and such that the boundary region improves resistance to delamination at an edge of the covered substrate region.

2. The method of adhering the protective layer as claimed in claim 1, further comprising depositing the intermediate layer by vapor deposition.

3. The method of adhering the protective layer as claimed in claim 1, further comprising depositing the intermediate layer by sputter deposition.

4. The method of adhering the protective layer as claimed in claim 1, wherein the protective layer is a flexible protective layer.

5. The method of adhering the protective layer as claimed in claim 1, wherein the portion of the substrate region includes platinum, wherein the intermediate layer includes titanium, and wherein the protective layer includes silicon.

6. The method of adhering the protective layer as claimed in claim 1, wherein the surface energy of the modified substrate region is higher than the surface energy of the portion of the substrate region, thereby providing the increased adhesion.

7. The method of adhering the protective layer as claimed in claim 5, wherein the stability of the chemical bond between the modified substrate region and the protective layer is increased relative to the stability of the chemical bond that would be present between the portion of the substrate region and the protective layer.

8. The method of adhering the protective layer applied to a substrate region as claimed in claim 4, wherein after application of the protective layer to the substrate region is completed, an exposed substrate region having no protective layer is present, thereby defining a boundary region between the covered substrate region and the exposed substrate region.

9. The method of adhering the protective layer as claimed in claim 1, wherein the protective layer forms a hermetic protective layer between an exterior of the IMD and the portion of the substrate region.

10. The method of adhering the protective layer as claimed in claim 1, wherein the portion of the substrate region includes a mobile oxide layer, wherein the intermediate layer includes a stable oxide component, and wherein the protective layer includes a silicon component.

11. The method of adhering the protective layer as claimed in claim 1, wherein the portion of the substrate region has a surface energy that is substantially lower than the surface energy of the intermediate layer.

12. The method of adhering the protective layer applied to a substrate region as claimed in claim 1, wherein after application of the protective layer to the substrate region is completed, an exposed substrate region having no protective layer is present, thereby defining a boundary region between the covered substrate region and the exposed substrate region.

13. The method of adhering the protective layer applied to a substrate region as claimed in claim 9, wherein the modified substrate region is substantially co-located with the boundary region.

14. The method of adhering the protective layer applied to a substrate region as claimed in claim 1, further including the step of introducing a layer of sulphur atoms to the portion of the substrate region.

15. An implantable medical device (IMD), comprising:

a housing assembly containing electronics components, the housing assembly including a substrate region comprising a modified substrate region that includes a covered substrate region and a boundary region;

an intermediate layer adhering to the substrate region along substantially the entire modified substrate region; and

a protective layer adhering to at least the intermediate layer along the covered substrate region but not along the boundary region such that, at the boundary region, the protective layer is not adhered to the intermediate layer,

wherein an increased adhesion exists between the protective layer and the intermediate layer relative to adhesion that would be present between the substrate region and the protective layer and wherein the boundary region improves resistance to delamination at an edge of the housing assembly.

16. The implantable medical device of claim 15, wherein:

the housing assembly includes a housing having an opening and a metal plate welded to a housing hermetically sealing the opening;

wherein the substrate region is located on at least the metal plate.

17. The implantable medical device of claim 15, wherein the protective layer extends from the substrate region onto the housing.

18. The implantable medical device of claim 16, wherein the plate includes a mobile oxide layer, wherein the intermediate layer includes a stable oxide component, and wherein the protective layer includes a silicon component.

19. The implantable medical device of claim 16, wherein the plate includes platinum, wherein the intermediate layer includes titanium, and wherein the protective layer includes silicon.

20. An implantable medical device (IMD), comprising:

a housing assembly containing electronics components, the housing assembly including a substrate region comprising a modified substrate region that includes a covered substrate region and a boundary region;

an intermediate layer adhering to the substrate region along the modified substrate region; and

a protective layer adhering to at least the intermediate layer such that the protective layer adheres to the intermediate layer along the covered substrate region but does not adhere to the intermediate layer along the boundary region,

wherein a bond between the intermediate layer and the protective layer is a Ti—

O—

Si bond, and wherein the Ti—

O—

Si bond is more stable than a PT—

O—

Si bond

and wherein the boundary region improves resistance to delamination at an edge of the housing assembly.