Test Method and Apparatus for Verification of Medical Device Functionality

• US 20090270805A1
• Filed: 07/05/2009
• Published: 10/29/2009
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Das, Stephen D.
• Granted Patent: US 8,137,311 B2
• Time in Patent Office: Days
• US Class Current: 604/111
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation
• CPC Class Codes: Y10T 29/49236 Fluid pump or compressor making

Abstract

This invention relates to methods, apparatuses and systems for testing the functionality of the pumping mechanism of a medical device, e.g., an implantable infusion pump, while the medical device is contained within a shipping package. The test apparatus enables such functional verification, without opening the shipping package, when the medical device is still contained within the package that has been appropriately sealed to maintain sterility of the medical device.

Claims

1-22. -22. (canceled)

23. An apparatus, comprising

a package including a sealed interior;

an infusion pump, including a pump case, a fluid transfer device within the pump case and an outlet that receives fluid from the fluid transfer device, located within the sealed interior of the package; and

an indicator located within the sealed interior and outside the pump case, operably connected to outlet, and configured to provide an indication that is discernible outside the package in response to a fluid discharge at the outlet and/or a pressure change at the outlet.

24. An apparatus as claimed in claim 23, wherein the sealed interior comprises a substantially sterile sealed interior.

25. An apparatus as claimed in claim 23, wherein the outlet comprises a catheter outlet port.

26. An apparatus as claimed in claim 23, wherein

the indicator is visible through the package;

and

the indicator is configured to provide a visible indication in response to a fluid discharge at the outlet and/or a pressure change at the outlet.

27. An apparatus as claimed in claim 26, wherein the indicator is selected from the group consisting of a distendible membrane and a slidable piston.

28. An apparatus as claimed in claim 26, wherein the indicator comprises a tube that is connected to the outlet and is sufficiently transparent to permit a user to visually observe fluid movement within the tube.

29. An apparatus as claimed in claim 26, wherein the indicator includes a light source.

30. An apparatus as claimed in claim 23, wherein the indicator includes a sound source.

31. A method of packaging an infusion pump, the infusion pump including a pump case, a fluid transfer device within the pump case and an outlet that receives fluid from the fluid transfer device, the method comprising:

operably connecting an indicator, which is configured to provide a user discernible indication in response to a fluid discharge at the outlet and/or a pressure change at the outlet, to the outlet; and

sealing the infusion pump and the indicator within a package with the indicator located outside the pump case.

32. A method as claimed in claim 31, wherein

the oulet comprises a catheter outlet port;

and

operably connecting an indicator comprises operably connecting an indicator, which is configured to provide to a user discernible indication in response to a fluid discharge at the outlet and/or a pressure change at the outlet, to the catheter outlet port.

33. A method as claimed in claim 31, wherein sealing the infusion pump and the indicator within a package comprises sealing the infusion pump and the indicator within a package with a sterile interior with the indicator located outside the pump case.

34. An apparatus, comprising

a package including a sealed interior;

an infusion pump, including a pump case, a fluid transfer device within the pump case and an outlet that receives fluid from the fluid transfer device, located within the sealed interior of the package; and

an indicator, located within the sealed interior and outside the pump case, including a device configured to provide an indication that is discernible outside the package in response to a fluid discharge at the outlet and/or a pressure change at the outlet and means for mounting the device on the medical device outlet.

35. An apparatus as claimed in claim 34, wherein the package includes a substantially transparent cover.

36. An apparatus as claimed in claim 34, wherein the sealed interior comprises a substantially sterile sealed interior.

37. An apparatus as claimed in claim 34, wherein the device comprises a light source.

38. An apparatus as claimed in claim 34, wherein the device comprises a sound source.

39. An apparatus as claimed in claim 34, wherein the device comprises a tube having sufficient transparency to enable a user to visually discern movement of fluid within the tube.

40. An apparatus as claimed in claim 34, wherein the device comprises a distendible membrane.

41. An apparatus as claimed in claim 34, wherein the device comprises a slidable piston.

42. An apparatus as claimed in claim 34, wherein the outlet comprises a catheter outlet port.