DIELECTRIC FLUID FILLED ACTIVE IMPLANTABLE MEDICAL DEVICES

• US 20090312835A1
• Filed: 06/03/2009
• Published: 12/17/2009
• Est. Priority Date: 06/17/2008
• Status: Abandoned Application

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A.
• Application Number:
  US12/477,422
• Publication Number:
  US 20090312835A1
• Time in Patent Office: Days
• US Class Current: 623/3.100
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

Active implantable medical devices (AIMDs) are backfilled with a dielectric fluid to increase the volts per mil dielectric breakdown strength between internal circuit elements. In a method for backfilling the AIMD with dielectric fluid, substantially all air and moisture is evacuated from the AIMD housing prior to backfilling the AIMD housing with a dielectric fluid having a dielectric breakdown strength greater than air, nitrogen or helium. The AIMD is constructed to accommodate volumetric expansion or contraction of the dielectric fluid due to changes of pressure or temperature of the dielectric fluid to maintain integrity of the AIMD.

Claims

1. A method for backfilling an active implantable medical device (AIMD) with a dielectric fluid, comprising the steps of:

providing an AIMD having a housing with a fluid inlet/outlet;

evacuating substantially all air and moisture from the housing through the housing inlet/outlet;

filling the housing with a dielectric fluid having a dielectric breakdown strength greater than air, nitrogen or helium; and

sealing the housing inlet/outlet.

2. The method of claim 1, wherein the AIMD comprises a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, or a Bion.

3. The method of claim 1, wherein the evacuating step comprises the step of placing the housing of the AIMD within a vacuum chamber for a period of time.

4. The method of claim 3, wherein the evacuating step includes the step of heating the housing.

5. The method of claim 3, wherein the filling step comprises the step of backfilling a portion of the vacuum chamber with the dielectric fluid.

6. The method of claim 5, including the step of placing the dielectric fluid under a positive pressure.

7. The method of claim 6, including the step of introducing an inert gas into the vacuum chamber.

8. The method of claim 7, wherein the inert gas comprises nitrogen.

9. The method of claim 1, wherein the dielectric fluid has dielectric breakdown strength at least double that of air, nitrogen or helium under similar operating conditions.

10. The method of claim 1, wherein the dielectric fluid has dielectric breakdown strength of at least 100 volts per mil.

11. The method of claim 1, wherein the filling step comprises the step of filling the housing with at least one of sulfur hexaflouride, mineral oil, or silicone oil.

12. The method of claim 1, including the step of accommodating changes of pressure or temperature of the dielectric fluid to maintain housing integrity.

13. The method of claim 12, wherein the sealing step includes the step of accommodating expansion or contraction of the dielectric fluid in response to changes of pressure or temperature of the dielectric fluid.

14. The method of claim 13, wherein the accommodating step includes the step of providing an expandable bellows having an inlet in fluid communication with the AIMD.

15. The method of claim 13, wherein the accommodating step includes the step of providing a resiliently flexible housing, plate or cap configured to deflect in response to changes in dielectric fluid pressure or temperature.

16. The method of claim 12, wherein the accommodating step includes the step of inserting a resiliently flexible member in the housing which contracts or expands in size in response to changes of pressure or temperature of the dielectric fluid.

17. The method of claim 16, wherein the member comprises a foam material or a resilient sphere.

18. The method of claim 12, wherein the accommodating step includes the step of providing a recessed inlet/outlet having an flexible sealing member associated therewith.

19. The method of claim 18, wherein the sealing member comprises a sphere seated within a recess of an end cap.

20. The method of claim 12, wherein the accommodating step includes the step of providing a bellows associated with an end cap.

21. An active implantable medical device (AIMD), comprising:

a housing;

electronic components disposed within the housing;

dielectric fluid substantially filling the housing, the dielectric fluid having a dielectric breakdown strength exceeding that of air, nitrogen, or helium; and

means for accommodating change of pressure or temperature of the dielectric fluid to maintain housing integrity.

22. The AIMD of claim 21, wherein the AIMD comprises a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, or a Bion.

23. The AIMD of claim 21, wherein the dielectric fluid has a dielectric breakdown strength at least double that of air, nitrogen or helium under similar operating conditions.

24. The AIMD of claim 21, wherein the dielectric fluid has a dielectric breakdown strength of at least 100 volts per mil.

25. The AIMD of claim 21, wherein the dielectric fluid comprises at least one of sulfur hexaflouride, mineral oil, or silicone oil.

26. The AIMD of claim 21, wherein the accommodating means comprises an expandable bellows attached to an outlet of the housing and in fluid communication with the dielectric fluid.

27. The AIMD of claim 21, wherein the accommodating means comprises at least one of the walls of the housing being resiliently flexible.

28. The AIMD of claim 21, wherein the accommodating means comprises a resiliently flexible cap of the AIMD.

29. The AIMD of claim 21, wherein the accommodating means comprises a closed-cell foam material or a resilient sphere disposed within the housing.

30. The AIMD of claim 21, wherein the accommodating means comprises a recessed inlet/outlet having an resiliently flexible sealing member seated therein.

31. The AIMD of claim 30, wherein the accommodating means comprises an expandable bellows attached to an end cap and in fluid communication with the dielectric fluid.