Test method and apparatus for verification of medical device functionality
First Claim
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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.
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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.
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Citations
22 Claims
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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:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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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:
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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. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of verifying the functionality of an infusion pump contained in a sterile shipping package, said method comprising:
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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. - View Dependent Claims (18, 19, 20, 21, 22)
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Specification