IP Library Granted Patent US 7,604,614
Granted Patent B2
US 7,604,614 · App. 11/222,161 · Granted Oct 20, 2009

Test method and apparatus for verification of medical device functionality

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Quick Facts
Patent No.
US 7,604,614
App. No.
11/222,161
Granted
Oct 20, 2009
Kind
B2
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 (48)

1. A testing apparatus for use with a medical device that includes an outlet, is configured to produce a fluid discharge through the outlet and is contained in a sterile package, said testing apparatus comprising:

an RF transmitter external to the sterile package for generating a command signal to the medical device;

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

an indicator including a device within the sterile package configured to produce a user-discernible indication in response to fluid emission from the outlet and means for mounting the device on the medical device outlet.

2. The apparatus of claim 1 wherein the device comprises a light source.

3. The apparatus of claim 1 wherein the device comprises a sound source.

4. A testing apparatus for use with a medical device that includes an outlet, is configured to produce a fluid discharge through the outlet and is contained in a sterile package, said testing apparatus comprising:

a transmitter external to the sterile package for generating a command signal to the medical device;

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

an indicator within the sterile package including a tubing mounted to the medical device and having sufficient transparency to produce a user-discernible indication which enables a user to visually discern movement of fluid within the tubing in response to fluid emission from the outlet.

5. A system, comprising:

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

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

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

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

a distendible membrane responsive to fluid pressure generated by the infusion pump at the pump outlet port.

6. A system, comprising:

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

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

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

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

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.

7. The system of claim 6 wherein said transmitter comprises an RF transmitter.

8. The system of claim 6 , further comprising:

a liquid/gas interface movable within said visual tube, wherein the gas is placed between two liquid portions within said visual tube.

9. The system of claim 6 wherein said visual tube is marked with lines to indicate specific liquid volumes.

10. A method, comprising the steps of:

providing an infusion pump having a case defining an interior and an exterior, a fluid transfer device and a reservoir within the interior, and an outlet port associated with the exterior;

providing a sterile shipping package having a cavity therein;

mounting said infusion pump in said cavity;

sealing said cavity to contain a sterile environment therein;

transmitting a pump actuation command signal to the infusion pump within the sterile shipping package from outside of said sterile shipping package; and

providing an indication, which is discernible outside of said package, of any fluid discharge and/or pressure change which occurs at the outlet port in response to the pump actuation command signal.

11. The method of claim 10 wherein the indication comprises movement that is visually discernable outside of said sterile shipping package.

12. The method of claim 10 wherein the indication comprises light from a light source.

13. The method of claim 10 wherein the indication comprises sound from a sound source.

14. The method of claim 10 wherein said step of providing an indication further includes: sensing a fluid discharge and/or a pressure change at said outlet port.

15. A method, comprising the steps of:

providing an infusion pump having an outlet port;

providing a sterile shipping package having a cavity therein;

mounting said infusion pump in said cavity;

sealing said cavity to contain a sterile environment therein;

transmitting a pump actuation command signal to the infusion pump within the sterile shipping package from outside of said sterile shipping package; and

providing an indication, which is visually discernible outside of said package, of any fluid discharge and/or pressure change which occurs at the outlet port in response to the pump actuation command signal in the form of a movement of a membrane or a piston.

16. A testing apparatus for use with a medical device that includes an outlet, is configured to produce a fluid discharge through the outlet and is contained in a sterile package, said testing apparatus comprising:

an RF transmitter external to the sterile package for generating a command signal to the medical device;

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

an indicator mounted within the sterile package on the medical device outlet, 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, and configured to produce a visible movement in response to fluid emission from the outlet.

Assignments (7)
SECURITY INTEREST Recorded Jan 16, 2026
From: MEDTRONIC MINIMED, INC.; COMPANION MEDICAL, INC.
To: CITIBANK, N.A.
Reel/Frame 074394/0237 →
RELEASE OF SECURITY INTEREST Recorded Jul 14, 2025
From: THE ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
To: MEDTRONIC MINIMED, INC.
Reel/Frame 071698/0639 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 27, 2021
From: THE ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
To: MEDTRONIC MINIMED, INC.
Reel/Frame 057962/0741 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2019
From: MEDALLION THERAPEUTICS, INC.
To: THE ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
Reel/Frame 051287/0120 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2014
From: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
To: MEDALLION THERAPEUTICS, INC.
Reel/Frame 032892/0067 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SCHEDULE WHICH REFLECTED PATENT NUMBER AS 8,327,041 AND SHOULD HAVE BEEN REFLECTED AS 8,372,041. PREVIOUSLY RECORDED ON REEL 032815 FRAME 0188. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded May 6, 2014
From: MEDALLION THERAPEUTICS, INC.
To: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
Reel/Frame 032827/0478 →
SECURITY INTEREST Recorded May 2, 2014
From: MEDALLION THERAPEUTICS, INC.
To: ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH
Reel/Frame 032815/0188 →