Title:  Infusion pump with an electronically loadable drug library and a user interface for loading the library

United States Patent:  6,269,340

Assignee:  The General Hospital (Boston, MA); Baxter International (Deerfield, IL)

Filed:  October 27, 1997

A system for creating a customized drug library for an electronically loadable drug infusion pump, the system including a drug library containing a plurality of drug entries, there being associated with each drug entry a set of associated drug delivery parameters and/or drug delivery protocols for configuring the drug infusion pump; a tool for selecting a set of drug entries from among the plurality of drug entries in said drug library; a tool for adding the selected drug entries along with the sets of drug delivery information associated therewith to a customized library; and a loading tool for causing the system to electronically load the customized library into the drug infusion pump.

SUMMARY OF THE INVENTION

Applicants have recognized both the limitations of prior drug infusion technologies and the consequent risk to patients, and have developed a customizable drug library software capability for infusion pumps which avoids those limitations and consequent risks. The electronically customizable drug library, either by itself or interacting with an automatic drug recognition capability based upon a machine readable label or data carrier, avoids problems of the prior approaches and both facilitates and enhances the dissemination, training, and execution of appropriate and customary drug infusion practices found in critical care areas of hospitals.

In general, in one aspect, the invention is a system for creating a customized drug library for an electronically loadable drug infusion pump. The system includes a drug library containing a plurality of drug entries, there being associated with each drug entry a set of associated drug delivery parameters and/or drug delivery protocols for configuring the drug infusion pump. It includes means for selecting a set of drug entries from among the entries in said drug library; means for adding the selected drug entries along with the sets of drug delivery information associated therewith to a customized library; and loading means for causing the system to electronically load the customized library into the drug infusion pump.

Preferred embodiments include the following features. Each of the associated sets of drug delivery parameters includes information selected from a group of parameters including drug concentration, drug delivery rate, drug dose, and bolus size. The group of parameters includes minimum, default and maximum drug delivery rate; minimum, default and maximum dose; minimum, default and maximum bolus size; and maximum bolus rate. The system also includes means for creating a drug configuration within the customized library that does not exist in the drug library. The system further includes means for editing an existing drug configuration in the customized library. In addition, the system includes a graphical tool that generates a graph for display on a computer screen, the graph enabling the user to select an appropriate drug concentration for a given body weight. The graph is a two-dimensional log--log graph wherein one axis is body weight and the other axis is fluid flow rate. There are one or more curves plotted on the graph, each of the one or more curves being for a given drug concentration and different doses. 

Preferred embodiments also include the following features. The system includes a list of available mode options, means for identifying one or more modes from that list and means for adding the identified modes to the customized library. The modes specify the units available for expressing the drug delivery information and the identified modes are those the modes that will be available in the infusion pump when the customized library is loaded into the infusion pump. The available mode options include milliliter/hour, units/hour, micrograms/minute, and micrograms/kilogram/minute. The system also includes a list of names of syringe manufacturers, means for selecting names of syringe manufacturers from that list and means for adding the selected names of syringe manufactures to the customized library. The selected names of syringe manufacturers identify syringes that can be used in the drug infusion pump when the customized library is loaded into the infusion pump. The system further includes a list of syringe sizes, means for one or more syringe sizes from that list and means for adding the selected syringe sizes to the customized library.

Also in preferred embodiments, the system includes means for representing a set of features within the customized library, each of which can be toggled on or off, and means for toggling on or off each of the features. The set of features includes a drug library enable flag, wherein the drug library enable flag either enables or disables, depending upon the condition of the drug library enable flag, access to the drug entries within the customized library when the customized library is loaded into said drug infusion pump. The set of features includes a syringe recognition flag, wherein the syringe recognition flag either enables or disables, depending upon the condition of the syringe recognition flag, a syringe recognition capability within the drug infusion pump when the customized library is loaded into the drug infusion pump. The set of features includes a syringe detection flag, wherein the syringe detection flag either enables or disables, depending upon the condition of the syringe detection flag, a syringe detection capability within the drug infusion pump when the customized library is loaded into the drug infusion pump. The set of features includes a volume limit detection flag, wherein the volume limit flag either enables or disables, depending upon the condition of the volume limit flag, a function within the pump that enables the user to specify a volume limit for a drug delivery configuration when the customized library is loaded into the drug infusion pump.

In addition, preferred embodiments include means for causing the system to read pump configuration information from the drug infusion pump. In the system, the means for selecting is normally disabled and the system further includes password protection logic that serves to enable the selection means but only if a system user supplies a preselected password to the password protection logic. There are a plurality of access levels, each of which corresponds to a different set of access privileges in the system and the system includes a table associating each of a plurality of users with a corresponding one of the access levels and the password protection logic uses that table to assign access privileges to the system user. The system also includes an access control means for controlling access to the loading means, wherein the access control means permits access to the loading means if a system user satisfies a set of preconditions and denies access to the loading means if the system user fails to satisfy the set of preconditions. The access control means includes a sign-off table for recording a sign-off and the access control means permits access to the loading means if a valid approval sign-off exists in the sign-off table and denies access to the loading means if a valid approval sign-off does not exist in the sign-off table. The sign-off table includes an system user name and a system user date and time and an approval name and an approval date and time. The system user date and time records when a last modification of the customized file by the user occurred and the access control means permits access to the loading means if the approval date and time is later than the system user date and time and denies access to the loading means if the approval date and time is later than the system user date and time.

In general, in another aspect, the invention is a system for use with a computer. The system includes a storage medium containing a drug library, the drug library containing a plurality of drug entries, there being associated with each drug entry a set of associated drug delivery information for configuring a programmable drug infusion pump, the storage medium being readable by the computer. The system also includes a program that runs on the computer, the program including means for enabling a user to select a set of drug entries from among the plurality of drugs entries in the drug library; means for enabling the user to add the selected drug entries along with the sets of drug delivery information associated therewith to a customized library; and means for enabling the user to cause the computer to electronically load the customized library into the drug infusion pump.

In general, in yet another aspect, the invention is a drug infusion pump for use with a container containing a particular drug. The pump includes a drive mechanism for causing the particular drug to be delivered to a patient from the container; a programmable controller controlling the drive mechanism; an electronically loadable memory inside the pump; input circuitry through which the electronically loadable memory can be electronically loaded with a drug library, the drug library containing a plurality of drug entries, there being associated with each drug entry a set of associated drug delivery parameters and/or drug delivery protocols for configuring the drug infusion pump; a user interface enabling a user to program the programmable controller. The user interface includes means for enabling the user to select a drug entry from the electronically loaded drug library; and means for configuring the programmable controller with the set of drug delivery parameters associated with the selected drug.

Preferred embodiments include the following features. The container is a syringe and the drive mechanism operates the syringe. The electronically loadable memory is non-volatile memory, e.g. EEPROM. The user interface includes a control panel through which the user can program the programmable controller and a display screen for displaying drug entries from the drug library. Each of the associated sets of drug delivery parameters includes information selected from a group of parameters including drug concentration, drug delivery rate, drug dose, and bolus size. The electronically loaded drug library contains a list of available mode options specifying the units available for expressing drug delivery information, and the drug infusion pump offers the user the list of available mode options from which to make a selection when the electronically loaded drug library is in the pump. The electronically loaded drug library contains a list of names of syringe manufacturers identifying syringes that can be used in the drug infusion pump, and the drug infusion pump offers the user the list of names of syringe manufacturers from which to make a selection when the electronically loaded drug library is in the pump. The loaded drug library contains a list of syringe sizes identifying syringes that can be used in the drug infusion pump, and the drug infusion pump offers the user the list of syringe sizes from which to make a selection when the electronically loaded drug library is in said pump. The loaded drug library contains a set of features, each of which is either be toggled on or off, and the pump offers the user only the features from among the set of features that are toggled on when the electronically loaded drug library is in said pump.

In general, in still another aspect, the invention is a drug infusion pump for use with a container containing a given drug, the container including a machine readable label, the label specifying an identifier of the given drug and possibly other information about the given drug. The pump includes a drive mechanism for causing the given drug to be delivered to a patient from the container; a programmable controller controlling the drive mechanism; a memory for storing a drug library containing a plurality of drug entries, there being associated with each drug entry a set of associated drug delivery parameters for configuring the drug infusion pump; a label reader for reading the contents of the label on the container; means responsive to the label reader for identifying an entry in the drug library that corresponds to the given drug; means for configuring the programmable controller by using the set of drug delivery parameters associated with the identified entry from the drug library; and means for causing the controller to run the drive mechanism using the set of drug delivery parameters associated with the identified entry from the drug library.

In preferred embodiments, the machine readable label is a touch memory. In addition, the label includes an expiration date for the given drug and the pump includes an internal clock indicating a current date; means for comparing the expiration date as read by the label reader to the current date as indicated by the internal clock; and means for issuing a warning if the current date is later than the expiration date. The pump further includes means for preventing the controller from running the drive mechanism if the current date is later than the expiration date.

In general, in another aspect, the invention is a drug infusion pump including a drive mechanism for causing the given drug to be delivered to a patient from the container; a programmable controller controlling the drive mechanism; a memory containing an event log; means for configuring the programmable controller to deliver the given drug in accordance with a set of drug delivery parameters; a user interface for operating the pump; and means for creating in the event log a sequence of event records, each event record documenting a different event in the operation and/or programming of the pump.

In preferred embodiments, the events that are recorded in the event log include occurrences of alarms.

A significant advantage of the present invention is that it enables clinicians to easily customize their drug infusion pumps by electronically injecting customized drug libraries and configuration data into them. Thus, the clinicians can easily customize their drug infusion pumps with drug-associated information that the clinician has heretofore had to remember.

The invention offers users ease in customizing their pumps to reflect exactly the unique clinical practices and preferences of a community of users (typically a single hospital, or a subset of users within that hospital) sharing a group of infusion pumps, thus essentially incorporating the written practices, policies, and procedures within the device, at the point of use.

The electronic customizability of drug infusion pumps allows hospital-based users continually and easily to update their infusion devices to reflect new drug introductions, modifications or minor variants of dosing regimens, local practices with respect to the compounding together of several medications in one fluid container, and advances in medical knowledge.

The interaction between the internal drug library and the automated drug recognition capability using machine readable labels provides a seamless link between drug container-associated information and pump resident information or knowledge necessary for infusions.

The ability to log pump events and to download them from the pump to a personal computer enables clinicians to perform automated record-keeping relative to drug infusion history for a specific patient, and to collect device utilization information.

The invention offers users the ability (using the graphical tool) to perform "what-if" prospective analysis of the impact of a particular choice of drug concentration or mixing upon the fluid flow rates which would result if certain doses or dose rates were chosen for patients of various body sizes.

The invention provides the users with a layer of safety in terms of preventing programming errors during the set-up of an infusion pump as, for example, entering 0.02 instead of 0.2.

Claim 1 of 32 Claims

What is claimed is:

1. A system for creating a customized drug library for an electronically loadable infusion pump, said system comprising:

a memory for storing a drug library containing a plurality of drug entries, there being associated with each drug entry associated drug delivery information;

a user interface module enabling a user to select a set of drug entries from among said plurality of drug entries in said drug library, to add the selected drug entries along with the drug delivery information associated therewith to an electronically-stored customized library which presents a plurality of drug selection options to the user of the infusion pump, and to electronically load said electronically-stored customized library into the drug infusion pump.

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