Drug pump systems and methods

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S031000

Reexamination Certificate

active

06475180

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to systems and methods for operating drug delivery devices, such as drug pumps.
BACKGROUND OF THE INVENTION
Various ambulatory medical devices are known for treating and/or monitoring patients at a remote site away from the caregiver's or clinician's office. One example of an ambulatory medical device is a drug delivery device, such as a drug pump, for providing periodic or continuous drug delivery to the patient when the patient is away from the caregiver's office.
Certain drugs rarely achieve their maximum therapeutic action through conventional injection techniques. Many drugs reach their full potential only through precise delivery over an extended period of time. With controlled drug infusion through a drug pump, the drug can be given at a precise rate that will keep the drug concentration within the therapeutic margin and out of the toxic range. Ambulatory drug pumps can provide appropriate drug delivery to the patient at a controllable rate which does not require frequent medical attention and which allows the patient to leave the hospital or caregiver's office.
A failure to adequately monitor the drug pump and the patient's usage of the drug pump can reduce or eliminate any benefits the patient may have received from a proper drug delivery therapy. In some cases, the drug therapies can have serious health consequences to the patient if the drugs are not administered properly.
Various concerns arise in connection with operation of the drug pumps. One concern arises in that the drug pump must be adequately monitored when the patient utilizes the drug pump at a remote site. Another concern relates to controlling the sophisticated therapies desired by the caregivers and the patients for the ambulatory drug pumps. Additional concerns relate to accurate pumping of an appropriate drug therapy. Still further concerns relate to the costs to manufacture and maintain the drug pump.
There is a need for drug pump operating systems and methods which address the above concerns and other concerns.
SUMMARY OF THE INVENTION
The present invention concerns a drug pump including a control module interconnectable to a cassette, the cassette being linked to a remote fluid reservoir or an enclosed fluid reservoir disposed within the cassette. The control module includes a pump mechanism for pumping fluid from the fluid reservoir to the patient. The control module includes a control system including a pump application program for providing a desired therapy, and patient specific settings accessed by the pump application program to deliver the particular therapy desired to the patient. The control system further includes a display and a keyboard. Preferably, a communications port is provided to transfer information to and from the drug pump. The drug pump is programmable to allow for different pump application programs for pumping different therapies to a patient, such as an antibiotic therapy, a chemotherapy, a pain control therapy, and a nutritional therapy.
Systems and methods are provided for communication between two drug pumps or between a drug pump and a computer. Further systems and methods are provided for simulating a pump, such as for training purposes. Systems and methods are further provided for reprogramming the pump application program including a flash memory resident within the control module. Systems and methods are also provided for identifying a cassette mounted to the control module. Systems and methods are further provided for automated testing of the pump systems, such as operation of the pumping mechanism.


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