Hermetic implantable stimulator

• US 7,742,817 B2
• Filed: 03/04/2005
• Issued: 06/22/2010
• Est. Priority Date: 03/04/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Colvin, Michael S., Halberg, Leslie I., Malinowski, Zdzislaw B.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/073,290
• Publication Number:
  US 20060200200A1
• Time in Patent Office: 1,936 Days
• Field of Search: 607/36
• US Class Current: 607/36
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: H05K 3/284 for encapsulating mounted components H05K1/185 takes precedence

Abstract

An implantable medical device, e.g., an implantable pulse generator, having a non-metal sealed housing and method of making same. An exemplary embodiment of the device includes a replenishable power source, coupling electronic components configured to generate a pulse signal to the replenishable power source, and an inorganic coating covering the electronic components and the power source to seal, preferably hermetically, the electronic components and the power source from a body environment.

Claims

1. A method of forming an implantable medical device, comprising:

providing an electronic assembly comprising a circuit board and one or more electronic components mounted on the circuit board;

electrically coupling a feedthru pin to the electronic assembly;

applying a mask to a portion of the feedthru pin;

encapsulating the electronic assembly with a non-metallic hermetic composite after the mask has been applied to the feedthru pin to seal the electronic assembly from a body environment;

removing the mask from the feedthru pin to expose the portion of the feedthru pin;

and

coupling a connector assembly to the exposed portion of the feedthru pin after the electronic assembly has been encapsulated with the non-metallic hermetic composite.

2. The method of claim 1, wherein encapsulating the electronic assembly with the non-metallic hermetic composite comprises applying an inorganic coating to the electronic assembly.

3. The method of claim 2, wherein encapsulating the electronic assembly with the non-metallic hermetic composite comprises applying a layer of parylene to the electronic assembly.

4. The method of claim 2, wherein the inorganic material is selected from the group consisting of silicon nitride, silicon dioxide, and silicon oxinitride.

5. The method of claim 2, wherein applying the inorganic coating to the electronic assembly comprises reactive sputtering.

6. The method of claim 1, further comprising:

mounting a rechargeable power source to the electronic assembly; and

encapsulating the rechargeable power source with the non-metallic hermetic composite.

7. The method of claim 6, wherein the rechargeable power source is mounted to the printed circuit board opposite the one or more electronic components.

8. An implantable medical device, comprising:

an electronic assembly comprising a circuit board and one or more electronic components mounted to the circuit board;

a feedthru pin electrically coupled to the electronic assembly;

a non-metallic hermetic composite encapsulating the electronic assembly, wherein at least a portion of the feedthru pin is not encapsulated by the non-metallic hermetic composite;

a connector assembly coupled to the at least a portion of the feedthru pin; and

a layer of impact resistant epoxy disposed over the electronic assembly and connector assembly.

9. The implantable medical device of claim 8, wherein the non-metallic hermetic composite comprises an inorganic coating.

10. The implantable medical device of claim 9, wherein the non-metallic hermetic composite comprises a layer of parylene.

11. The implantable medical device of claim 9, wherein the inorganic material is selected from the group consisting of silicon nitride, silicon dioxide, and silicon oxinitride.

12. The implantable medical device of claim 8, further comprising a rechargeable power source to the electronic assembly, wherein the rechargeable power source is encapsulated with the non-metallic hermetic composite.

13. The implantable medical device of claim 12, wherein the rechargeable power source is mounted to the printed circuit board opposite the one or more electronic components.

14. The implantable medical device of claim 8, wherein the epoxy layer is in contact with the non-metallic hermetic composite.

15. The implantable medical device of claim 8, further comprising a soft material encapsulating the electronic assembly and connector assembly.

16. The implantable medical device of claim 15, wherein the soft material is in contact with the epoxy layer.

17. The implantable medical device of claim 15, wherein the soft material comprises silicone rubber.

18. The implantable medical device of claim 15, further comprising suture holes formed in the soft material.

19. A method of forming an implantable medical device, comprising:

providing an electronic assembly comprising a circuit board and one or more electronic components mounted on the circuit board;

electrically coupling a feedthru pin to the electronic assembly;

encapsulating the electronic assembly with a non-metallic hermetic composite to seal the electronic assembly from a body environment, wherein at least a portion of the feedthru pin is exposed;

coupling a connector assembly to the exposed portion of the feedthru pin after the electronic assembly has been encapsulated with the non-metallic hermetic composite; and

applying a layer of impact resistant epoxy to the electronic assembly and connector assembly after encapsulating the electronic assembly with the non-metallic hermetic composite.

20. The method of claim 19, wherein the epoxy layer is applied directly onto the non-metallic hermetic composite.

21. The method of claim 19, further comprising encapsulating the electronic assembly and connector assembly with a soft material after applying the layer of impact resistant epoxy to the electronic assembly.

22. The method of claim 21, wherein the soft material is applied directly over the epoxy layer.

23. The method of claim 21, wherein the soft material comprises silicone rubber.

24. The method of claim 21, further comprising forming suture holes in the soft material.

25. The method of claim 19, wherein encapsulating the electronic assembly with the non-metallic hermetic composite comprises applying an inorganic coating to the electronic assembly.

26. The method of claim 25, wherein encapsulating the electronic assembly with the non-metallic hermetic composite comprises applying a layer of parylene to the electronic assembly.