Combined extracorporeal and drug delivery system and method

Inventors

Zacharia, John Ramez • Wittner, Bernd • Bivans, Matthew

Assignees

Vantive Health GmbH • Vantive US Healthcare LLC

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Publication Number

US-12427235-B2

Patent

Publication Date

2025-09-30

Expiration Date


Abstract

An extracorporeal and drug delivery system includes (i) a renal failure therapy machine operable with a blood filter in fluid communication with an arterial line and a venous line, the machine including (a) an effluent pump for pumping effluent from the blood filter at an effluent flowrate, and at least one of (b) a dialysis fluid pump for pumping dialysis fluid to the blood filter at a dialysis fluid flowrate, (c) a predilution pump for pumping replacement fluid into the arterial line at a predilution flowrate, or (d) a postdilution pump for pumping replacement fluid into the venous line at a postdilution flowrate; (ii) an infusion pump operable to deliver an intravenous (“IV”) drug to the patient at an IV drug flowrate; and (iii) a coordinating logic implementor configured to adjust the IV drug flowrate based on an amount of the IV drug removed via the effluent flowrate.

Core Innovation

The invention relates to an extracorporeal and drug delivery system that combines a renal failure therapy machine with an intravenous drug delivery system and coordinates IV drug delivery with effluent and fluid removal. The system includes a coordinating logic implementor that determines an effluent flowrate using a fluid balance equation that relates the effluent flowrate to ultrafiltration removal and a total patient fluid input rate including dialysis fluid flowrate and replacement fluid flowrates. The system further coordinates an infusion pump that delivers the IV drug to account for the IV drug amount removed via the effluent.

In a first variant, the coordinating logic implementor estimates a blood volume using a patient weight and determines an adjustment for an IV drug flowrate based on the estimated blood volume and an amount of the IV drug removed via the determined effluent flowrate. The logic determines an adjustment percentage by dividing the adjustment for the IV drug flowrate by the determined effluent flowrate. When the adjustment percentage is greater than a threshold, the coordinating logic iteratively determines the effluent flowrate and a resulting adjustment for the IV drug flowrate until the adjustment percentage is less than the threshold, and when less than the threshold, the system implements at least the adjustment for the IV drug flowrate at the infusion pump.

In a second variant, the coordinating logic implementor determines an adjustment to a concentration of the IV drug based on estimated blood volume and an amount of the IV drug removed via the determined effluent flowrate, determines an adjustment value by comparing the adjustment to the effluent flowrate, and iteratively determines an updated effluent flowrate and resulting adjustment to the concentration until the adjustment value is less than a threshold. In a further variant for a high flux dialyzer, the coordinating logic implementor determines an adjustment to a flowrate and/or a concentration of the IV drug based on an amount of dilution due to dialysis fluid flowrate and/or replacement fluid flowrates, compares the adjustment to an adjustment threshold, iteratively determines the adjustment until it falls below the threshold, and implements at least the adjustment at the infusion pump.

Claims Coverage

The document provides three independent claims. Across these claims, the core coverage centers on coordinating a renal failure therapy machine effluent/ultrafiltration behavior with IV drug delivery by determining effluent flowrate using a fluid balance equation and then adjusting IV drug flowrate and/or concentration via an iterative threshold-based logic implementor.

Coordinated renal failure effluent with IV drug flowrate adjustment via fluid balance equation

A coordinating logic implementor determines the effluent flowrate using a fluid balance equation that relates the effluent flowrate to a sum between an ultrafiltration removal rate and a total patient fluid input rate including dialysis fluid flowrate and replacement fluid flowrates; estimates a blood volume using patient weight; determines an adjustment for the IV drug flowrate based on the estimated blood volume and an amount of the IV drug removed via the determined effluent flowrate; determines an adjustment percentage dividing the adjustment for the IV drug flowrate by the determined effluent flowrate; when the adjustment percentage is greater than a threshold, iteratively determines the effluent flowrate and a resulting adjustment for the IV drug flowrate until the adjustment percentage is less than the threshold; and when the adjustment percentage is less than the threshold, implements at least the adjustment for the IV drug flowrate at the infusion pump.

Coordinated renal failure effluent with IV drug concentration adjustment via iterative threshold logic

A coordinating logic implementor determines the effluent flowrate using a fluid balance equation relating the effluent flowrate to ultrafiltration removal and total patient fluid input rate including dialysis fluid flowrate and replacement fluid flowrates; estimates a blood volume using patient weight; determines an adjustment to a concentration of the IV drug based on the estimated blood volume and an amount of the IV drug removed via the determined effluent flowrate; determines an adjustment value by comparing the adjustment to the determined effluent flowrate; when the adjustment value is greater than a threshold, iteratively determines the effluent flowrate and a resulting adjustment to the concentration of the IV drug until the adjustment value is less than the threshold; and when the adjustment value is less than the threshold, implements at least the updated effluent flowrate at the effluent pump.

Dilution-aware IV drug adjustment for high flux dialyzer with iterative threshold control

A coordinating logic implementor determines an adjustment to a flowrate and/or a concentration of the IV drug based on an amount of dilution of the IV drug due to at least one of the dialysis fluid flowrate, the predilution flowrate, or the postdilution flowrate; compares the adjustment to an adjustment threshold; when the adjustment is greater than the adjustment threshold, iteratively determines the adjustment to the flowrate and/or the concentration of the IV drug until the adjustment is less than the adjustment threshold; and when the adjustment is greater than the adjustment threshold, implements at least the adjustment to the flowrate and/or the concentration of the IV drug at the infusion pump.

Across the independent claims, the system coverage consists of determining effluent flowrate via a fluid balance equation, estimating blood volume using patient weight where applicable, and using a coordinating logic implementor to iteratively adjust IV drug flowrate or concentration, or dilution-compensated flowrate/concentration for a high flux dialyzer, based on an adjustment metric compared to a threshold, with implementation of the resulting adjustment at an infusion pump.

Stated Advantages

Reduced caregiver workload.

Improved accuracy of fluid removal and drug dosing.

Compatibility with existing equipment is emphasized.

Documented Applications

No documented applications found

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