Medical apparatus with patient data recording

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Reexamination Certificate

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Reexamination Certificate

active

06468242

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention is directed to an infusion pump used for the infusion of liquid medicants into a patient.
An infusion pump is used to automatically administer liquid medicant to a patient. The liquid medicant is supplied from a source of medicant and pumped into the patient via a catheter or other injection device. The manner in which the liquid is infused is controlled by the infusion pump, which may have various modes of infusion, such as a continuous mode in which the liquid medicant is continuously infused at a constant rate, or a ramp mode in which the rate of infusion gradually increases, then remains constant, and then gradually decreases.
An infusion pump is disclosed in U.S. Pat. No. 5,181,910 to Scanlon. That infusion pump is programmable and has a controller for automatically determining the interval between pump activations necessary to produce a substantially linear rate of increase or decrease in liquid flow during the administration of liquid medicant to a patient. The pump has a nonvolatile memory in which infusion parameters may be stored and from which such parameters may be retrieved.
SUMMARY OF THE INVENTION
The invention is directed to an infusion apparatus for infusing liquid into a patient over an infusion period beginning with an initial infusion and ending with a final infusion. During the infusion period, all infusion data relating to the operation of the infusion apparatus is stored in a non-volatile memory in the infusion apparatus to generate a complete historical record of such operation.
The infusion apparatus is provided with a housing, a pump disposed in the housing and adapted to pump liquid through a conduit, and a controller operatively coupled to the pump to cause the pump to deliver a plurality of infusions of liquid medicant during the infusion period, each of the infusions being made at a time and a flow rate. The apparatus has a non-volatile memory and means for storing infusion data in the non-volatile memory to generate a complete historical record of the infusions delivered during the infusion period.
The infusion data stored in the non-volatile memory may include programmed infusion data input to the infusion apparatus during programming of the apparatus. Such programmed data may include data representing the infusion mode, the infusion flow rate, the volume to be infused, and the infusion start time. The infusion data may also include data representing the time at which each infusion was made during the infusion period and the flow rate at which of each infusion was made.
Where the infusion apparatus is provided with run and hold keys to control the infusion, the infusion data may include the times at which each of those keys was pressed by the user. The infusion apparatus may be provided with a bolus-request key for requesting that a bolus infusion be made, in which case the infusion data stored in the non-volatile memory could include data representing the time at which the bolus-request key was pressed and whether the bolus infusion was made as requested.
The stored infusion data could also include data representing the time at which any alarms or malfunctions occurred and data representing the type of alarm or malfunction. If the infusion apparatus includes lockout means for preventing a user from programming the infusion apparatus, the stored infusion data could include data relating to the infusion modes that were locked out.
The automatic recording of the infusion data described above in the non-volatile memory during the programming and operation of the infusion apparatus will generate a historical data record of the use of the apparatus. This is advantageous in that the data record can be later retrieved from the non-volatile memory and used for various purposes, including clinical purposes to aid in determining how effective a particular infusion therapy was and treatment purposes to confirm that the prescribed infusion was actually delivered to the patient.
In another aspect, the invention is directed to an infusion apparatus having a housing, a pump disposed in the housing and adapted to pump liquid through a conduit, a non-volatile memory, means for presenting the patient with a plurality of questions to be answered by the patient, input means for allowing a patient to input a plurality of answers to the plurality of questions, and means for storing the answers in the non-volatile memory.
The questions may be related to the current health of the patient and/or to the patient's health history. The infusion apparatus may have a memory in which a plurality of question sets are stored, and the questions asked of the patient may be taken from one of the question sets which is selected based on a parameter relating to the type of infusion the patient is to receive, or has just received, the type of patient, or a particular health care provider. The questions may be asked prior to an infusion or after an infusion is delivered to the patient.
These and other features and advantages of the present invention will be apparent to those of ordinary skill in the art in view of the detailed description of the preferred embodiment, which is made with reference to the drawings, a brief description of which is provided below.


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