Systems and methods for regulating fluid infusion in a patient
Inventors
Assignees
Publication Number
US-11291769-B1
Publication Date
2022-04-05
Expiration Date
2041-07-01
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Abstract
Closed-loop systems and methods are described herein for regulating a flow of medication being intermittently infused to a patient based on one or more vital signs. The dosage rate of the medication can be adjusted periodically as needed to ensure the patient's vital sign remains with a target range. Various safeguards can be used to ensure the safety and efficacy of the closed-loop systems and methods.
Core Innovation
The invention presents closed-loop systems and methods for regulating the flow of medication, such as intravenously infused drugs, to a patient based on real-time monitoring of one or more vital signs. The system receives patient information including values of vital signs from at least one source (e.g., a sensor or transducer), a target value or range for these vital signs, and an initial dosage rate for the medication. A control algorithm compares the current vital sign value with the target, determines a differential value, and calculates an adjusted medication dosage rate accordingly.
The main problem addressed by the invention is the difficulty in manually managing and optimizing patient vital signs, such as blood pressure, during procedures like surgery. Manual adjustment is labor-intensive, prone to delays, can lead to patients spending significant time outside desired ranges, and may impose a cost burden by requiring continuous professional attention. There is a need for a closed-loop, automated approach to improve accuracy, efficiency, and patient safety in medication titration.
With this system, the control algorithm continually monitors patient vital sign data and periodically adjusts the medication dosage rate to maintain the vital sign within a desired target range. Built-in safeguards include monitoring dose adjustment rates, enforcing minimum timing intervals between changes to account for infusion line lag, limiting dose change magnitude, and generating alarms if patient conditions or system operations fall outside safe or expected parameters. These systems and methods are implemented via a combination of control units (with processors and memory), infusion devices, and non-transitory computer readable media containing the operating software.
Claims Coverage
There are three primary independent claims covering the method for regulating medication flow, a non-transitory computer readable medium containing the necessary software, and a system for automated medication regulation.
Method for closed-loop regulation of medication dosage based on patient vital signs
This method includes receiving from a first source information about a patient's vital sign and a target value or range, as well as receiving and storing a medication's initial dosage rate. If the vital sign is outside of the target range, a first control algorithm generates a revised dosage rate by: - Comparing the current and target values to obtain a differential. - Calculating a dosage adjustment using the differential and a drug scalar. - Producing the revised dosage rate as a function of this adjustment and the original dosage rate. The method delivers medication according to this revised rate, stores it, analyzes previous dosage rates, and generates an alarm command if the rate of change exceeds a threshold.
Non-transitory computer readable medium for automated medication regulation
This feature covers a computer readable medium storing a program with commands that cause a processor to: - Receive via a control unit patient vital sign information, target values, and an initial medication dosage rate (and store these). - Compare current and target values to compute a differential, then generate a dosage adjustment based on this differential and a drug scalar. - Generate a revised dosage rate as a function of the original dosage rate and the dosage adjustment. - Store revised dosage rates, analyze a set of prior dosage rates, generate an alarm if the rate of change over a set period exceeds a threshold, and deliver medication according to the revised dosage rate.
System for regulating medication flow using a control unit and control algorithm
The inventive system includes a control unit (comprising a processor and memory storing a control algorithm) that: - Receives information concerning a patient’s vital sign from a first source, as well as a target value/range and initial dosage rate. - Generates a revised dosage rate using a control algorithm that compares current and target values, calculates a dosage adjustment based on a differential and a drug scalar, and produces an updated dosage rate. - Sends command signals to an infusion device to deliver medication at the revised rate. - Stores dosage rate values, analyzes dosage rate history, and generates alarm commands if a rate of change in dosage exceeds a predetermined threshold.
In summary, the independent claims broadly protect the integration of patient monitoring, control algorithms generating dynamic dosage rates based on real-time data, computer program implementations, and systemic safeguards for automated and safer medication delivery.
Stated Advantages
Automated control results in a significantly higher percentage of time with the patient's vital sign maintained within the target range compared to manual control.
The closed-loop system provides more frequent and precise dosage adjustments, which leads to a lower total medication dose delivered to the patient.
The system reduces the percentage of intraoperative time patients spend in hypotension or hypertension compared to manual control methods.
The safeguards implemented in the system improve patient safety by preventing excessive or unsafe dosage adjustments.
The need for continuous professional attention is reduced, helping alleviate cost and resource burdens in clinical environments.
Documented Applications
Regulation of blood pressure in patients, particularly using vasopressors to maintain mean arterial pressure within a specified range during operations.
Automated intravenous medication infusion where control of any vital sign that can be influenced by intermittent medication administration is needed.
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