Test method and apparatus for verification of medical device functionality

• US 20060122652A1
• Filed: 09/08/2005
• Published: 06/08/2006
• 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 7,604,614 B2
• Time in Patent Office: Days
• US Class Current: 607/27
• 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 for testing the functionality of a medical device contained in a sterile package without compromising the sterility of said package, said apparatus comprising:

a transmitter external to said package for generating a command signal to the medical device, wherein the medical device is configured to produce a fluid discharge;

a receiver, which is part of the medical device, for responding to said command signal to actuate said device; and

an indicator mounted within said package responsive to the actuation of said device for producing an indication recognizable by a user.

2. The apparatus of claim 1 wherein said transmitter comprises an RF transmitter.

3. The apparatus of claim 1 wherein said indicator produces said indication within said package, said indicator being selected from the group consisting of a distendible, flexible membrane that movably responds to fluid pressure and a slidable piston that movably responds to fluid pressure, wherein the indication is a visible movement of the indicator, and wherein the package has sufficient transparency for viewing the visible movement.

4. The apparatus of claim 1 wherein said indicator produces said indication within said package, which indication is discernible outside of said package.

5. The apparatus of claim 4 wherein said indicator includes a tubing mounted to the medical device, the tubing and package having sufficient transparency to enable a user to visually discern movement of fluid within the tubing.

6. The apparatus of claim 4 wherein said indicator includes a light source energizable to produce said indication discernable outside of said package by said user.

7. The apparatus of claim 4 wherein said indicator includes a sound source energizable to produce said indication discernable outside of said package by said user.

8. A system for testing the functionality of an infusion pump contained in a sterile package without compromising the sterility of said package, said system comprising:

an infusion pump that can be actuated to produce a fluid discharge from a pump outlet port;

a shipping package for housing said pump in a sterile environment;

a transmitter external to said package for selectively generating a command signal;

a receiver mounted in said package for responding to said command signal for switching said pump to an operating state for producing said fluid discharge; and

an indication means in said package for signaling a user in response to fluid discharge or change of fluid pressure at said outlet port.

9. The system of claim 8 wherein said transmitter for generating said command signal comprises an RF transmitter.

10. The system of claim 8 wherein said indication means for signaling includes a distendible membrane responsive to fluid pressure generated by the infusion pump at the pump outlet port.

11. The system of claim 8 wherein said indication means for signaling includes a piston mounted for movement in response to fluid pressure generated by the infusion pump at the pump outlet port.

12. The system of claim 8 wherein said indication means for signaling includes a visual tube having an open proximal end coupled to said pump outlet port for accommodating fluid discharged therefrom, wherein the visual tube has sufficient transparency to enable fluid movement within the tube to be observed outside of the tube.

13. The system of claim 12 wherein said indication means for signaling comprises a liquid/gas interface movable within said tube, wherein the gas is placed between two liquid portions within the visual tube.

14. The system of claim 12 wherein the tube is marked with lines to indicate specific liquid volumes.

15. The system of claim 8 wherein said indication means for signaling includes a light source energizable to produce said indication discernable outside of said package by said user, and wherein the package has sufficient transparency to view the signaling.

16. The system of claim 8 wherein said indication means for signaling includes a sound source energizable to produce said indication discernable outside of said package by said user.

17. A method of verifying the functionality of an infusion pump contained in a sterile shipping package, said method comprising:

providing an infusion pump having an outlet port;

providing a shipping package having a cavity therein;

mounting said pump in said cavity;

sealing said cavity to contain a sterile environment therein;

transmitting a signal from outside of said package for actuating said pump to produce a fluid discharge and/or pressure change at said outlet port; and

providing an indication of said fluid discharge and/or said pressure change which is discernible outside of said package.

18. The method of claim 17 wherein said step of providing an indication includes mounting an indicator for movement and wherein said movement is visually discernable outside of said package.

19. The method of claim 18 wherein said step of providing an indication comprises delaying visual movement of a membrane and/or piston.

20. The method of claim 17 wherein said step of providing an indication includes providing a light source energizable to produce said indication.

21. The method of claim 17 wherein said step of providing an indication includes providing a sound source energizable to produce said indication.

22. The method of claim 17 wherein said step of providing an indication further includes:

sensing a fluid discharge and/or said pressure change at said outlet port.