Systems and methods for regulating fluid infusion in a patient
Inventors
Assignees
Publication Number
US-12138426-B2
Publication Date
2024-11-12
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 relates to closed-loop systems and methods for regulating the flow of medication or other fluids to a patient by automatically adjusting the dosage rate based on one or more vital signs. These systems receive vital sign information from at least one source, such as a transducer or other sensor, and use a control algorithm to compare the current value of a vital sign to a defined target value or range. The algorithm generates a revised dosage rate as a function of the previous or current dosage rate and the differential between the current and target vital sign values.
This innovation addresses the problem that manual control of medication to maintain blood pressure and other vitals during surgery is challenging and often results in patients spending significant time outside of the target vital sign range. Manual adjustments require continuous attention from medical professionals, which is difficult and can be cost prohibitive, particularly as multiple patients are often under care simultaneously.
The described systems include safeguards to enhance safety, such as storing previous dosage rates, analyzing trends for potential alarms, enforcing minimum time intervals between adjustments (based on line lag), and checking if revised dosage rates fall within prescribed limits. These measures help prevent unsafe conditions and unnecessary dosage changes, ensuring the system maintains patient vital signs such as mean arterial pressure within a desired range during intermittent intravenous infusion of medication.
Claims Coverage
The patent claims cover several inventive features focused on automated, safe, and effective regulation of medication infusion via closed-loop control, supported by multiple independent claims relating to methods, computer-readable media, and systems.
Automated adjustment of medication dosage using a control algorithm based on patient vital signs
A method involves receiving both a target value/range for a first vital sign and real-time vital sign information from a source. When the current value falls outside the target, a control algorithm calculates a differential, derives a dosage adjustment using a drug scalar value, generates a revised dosage rate as a function of the prior dosage rate and adjustment, and delivers medication according to this revised rate.
Safeguard of enforcing minimum time between dosage changes using line lag
The method calculates the elapsed time since the last dosage change and compares it to a minimum time period that is greater than or equal to the estimated line lag for medication delivery. If the elapsed time is less, the dosage rate remains unchanged, preventing excessive or unsafe dosage adjustments before prior changes are physiologically relevant.
Non-transitory computer readable medium implementing the control logic for closed-loop medication regulation
A computer program stored on a non-transitory medium contains commands to: receive vital sign and dosage information via a control unit; compute the differential value and dosage adjustment; ensure elapsed time exceeds minimum (line lag) before allowing dosage changes; and command delivery of medication at the revised rate, thereby enabling automation through software.
System for real-time, closed-loop medication infusion with control unit and safeguards
A system comprises a control unit with a processor and memory, configured to receive target values/ranges, receive and process vital sign information, and, only if sufficient time has elapsed based on line lag, adjust and send command signals for medication delivery at adjusted rates. The system may further store historical dosage data for analysis and alarm generation.
In summary, the claims emphasize methods, systems, and computer-readable media for automated, safe, and adaptive control of patient medication infusion based on real-time vital sign feedback and built-in safeguards tied to timing, limits, and validation of dosage changes.
Stated Advantages
Enables continuous optimization of medication dosing to maintain patient vital signs within target ranges, reducing deviations and associated risks.
Reduces the total dose of vasoactive medication administered while achieving better control of vital signs compared to manual methods.
Minimizes time patients spend in hypotension or hypertension during procedures by providing frequent, precise dosage adjustments.
Decreases the need for continuous attention by medical professionals, making patient care less labor-intensive and more cost-effective.
Provides safety through integrated safeguards such as dose limits, minimum time intervals based on line lag, and alarm generation for excessive dosage changes.
Documented Applications
Regulation of blood pressure in a patient during surgery by controlling the dosage of vasopressors via automated infusion systems.
Use with any medication administered by intermittent infusion to control and maintain a patient’s vital signs, including but not limited to mean arterial pressure.
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