Test method and apparatus for verification of medical device functionality

• US 8,137,311 B2
• Filed: 07/05/2009
• Issued: 03/20/2012
• 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.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US12/497,671
• Publication Number:
  US 20090270805A1
• Time in Patent Office: 989 Days
• Field of Search: 604/111, 604/131, 604/151, 604/891.1, 417/63, 206/570, 206/363, 206/459.1, 731/68
• 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. 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, in fluid communication with the 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.

2. An apparatus as claimed in claim 1, wherein the sealed interior comprises a sterile sealed interior.

3. An apparatus as claimed in claim 1, wherein the outlet comprises a catheter outlet port.

4. An apparatus as claimed in claim 1, 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.

5. An apparatus as claimed in claim 4, wherein the indicator is selected from the group consisting of a distendible membrane and a slidable piston.

6. An apparatus as claimed in claim 4, 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.

7. An apparatus as claimed in claim 4, wherein the indicator includes a light source.

8. An apparatus as claimed in claim 1, wherein the indicator includes a sound source.

9. An apparatus as claimed in claim 1, wherein

the infusion pump includes a reservoir located within the pump case;

and

the reservoir, fluid transfer device and outlet are arranged such that fluid flows from the reservoir to the outlet.

10. An apparatus as claimed in claim 9, wherein the fluid transfer device comprises a pump mechanism.

11. An apparatus as claimed in claim 1, wherein the infusion pump is configured to be surgically implanted after being removed from the package.

12. An apparatus as claimed in claim 1, wherein the package comprises a shipping package.

13. An apparatus as claimed in claim 12, wherein the infusion pump comprises an implantable infusion pump.