Peritoneal Dialysis System Using Pressure Feedback for Exchange Control

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Solution Overview

Problem

Current peritoneal dialysis systems lack an evidence-based method to determine optimal exchange parameters such as time, volume, and formulation for Tidal Peritoneal Dialysis, leading to inefficiencies, patient discomfort, and increased costs due to the inability to accurately assess ultrafiltrate production and cavity emptiness.

Innovation Solution

A system with on-board sensors and a microprocessor that measures pressure changes to differentiate between ultrafiltrate-induced pressure and other factors, allowing for real-time adjustment of exchange points and fluid management, combining Tidal and Batch modalities to optimize treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a fixed Dwell time is allocated for every given cycle, then the treatment protocol is simple to implement, but the system cannot accurately determine when ultrafiltration has ceased, leading to enhanced glucose absorption

Engineering Contradiction:
Improvefixed Dwell time allocationVSAvoidDwell termination timing
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system continuously monitors intra-abdominal pressure during the Dwell phase and uses this feedback to detect when ultrafiltration has ceased. The pressure sensor provides real-time data to the microprocessor, which automatically terminates the Dwell phase at the optimal moment, eliminating the need for fixed time allocations and preventing glucose reversal.

Inventive Principle:
Principle #23Feedback

2Duration of action of moving object

If the Dwell is allowed to proceed beyond the point when ultrafiltration has ceased, then the treatment duration is extended, but there is a danger of enhanced absorption of Glucose

Engineering Contradiction:
ImproveDwell phase durationVSAvoidGlucose absorption
Core Design Contradiction:
Duration of action of moving objectVSObject-generated harmful factors

Solution Approach 1:

The pressure monitoring system provides continuous feedback during the Dwell phase, enabling the microprocessor to detect the precise moment when ultrafiltration ceases and automatically terminate the phase. This feedback mechanism prevents both under-treatment and glucose reversal, optimizing the Dwell duration dynamically.

Inventive Principle:
Principle #23Feedback

3Object-affected harmful factors

If the Dwell is terminated prematurely, then glucose absorption is prevented, but the patient does not receive the target dosage

Engineering Contradiction:
ImproveGlucose absorption preventionVSAvoidtarget dosage delivery
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The system uses pressure feedback to detect the exact moment when ultrafiltration stops, ensuring the Dwell phase continues long enough to achieve complete ultrafiltration and target dosage delivery, but terminates immediately when this goal is achieved, preventing both under-treatment and glucose reversal.

Inventive Principle:
Principle #23Feedback

4Device complexity

If the drain volume is calculated based on an estimate of the expected UF, then the calculation is simple, but the likelihood of Drain pain occurs when the cavity is empty

Engineering Contradiction:
Improvedrain volume calculationVSAvoidDrain pain
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The system uses real-time pressure feedback during the Drain phase to detect when the peritoneal cavity becomes empty. The microprocessor automatically terminates the Drain phase at this point, preventing the harmful effect of attempting to drain an already empty cavity, which causes patient discomfort. This eliminates the need for complex predictive calculations.

Inventive Principle:
Principle #23Feedback

5Measurement precision

If on-board pressure sensors and microprocessor control are implemented, then evidence-based determination of exchange parameters is achieved, but the device complexity increases

Engineering Contradiction:
Improveexchange parameter determinationVSAvoidsensor and control system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system uses the patient's own physiological pressure changes as the measurement signal, requiring only a simple pressure sensor and microprocessor to automatically perform measurements, calculations, and treatment adjustments. This self-service approach achieves precise evidence-based control without requiring complex external monitoring equipment or manual interventions.

Inventive Principle:
Principle #25Self-service

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enables evidence-based determination of exchange points, reduces patient discomfort, and optimizes treatment efficiency by accurately measuring ultrafiltrate production and cavity emptiness, thereby improving the quality and duration of dialysis.

Implementation Method 1

the peritoneal membrane of the patient's abdominal cavity as a filter to remove toxins via specialized solutions called dialysates

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

the majority of the cleansing process takes place during the Dwell. It is this phase that removes the waste products, known as the Ultrafiltrate (UF), from the blood

Methodology Applied
Scientific EffectOsmosis: Osmosis

Implementation Method 3

A system with on-board sensors and a microprocessor that measures pressure changes to differentiate between ultrafiltrate-induced pressure and other factors

Methodology Applied
Scientific EffectPressure measurement:

Data Source

PatentEP3233152B1System and method for peritoneal dialysis
Publication Date: 2021.02.03 NEWSOL TECH
  • EP3233152B1 patent drawingFigure 1A~1C
  • EP3233152B1 patent drawingFigure 1D
  • EP3233152B1 patent drawingFigure 2

AI summary

The invention relates to a system of performing an evidence Dialysis modality of Batch, Tidal or a combination of both. The system: isolates cavity volume changes due only to ultrafiltrate; determines the volume of a patient cavity; determines a full cavity; determines an objective time to initiate an exchange; and determines an empty cavity. One or more combination of these features provide for evidence base Fill, Dwell, and Drain sequences. The system comprises: a cassette having a heated region and a sensor region for measurements. A valve manifold supplies a patient connection with fluid. A microprocessor receives pressure measurements, controls the heated region and activates a volumetric pump to deliver or extract discrete increments of the fluid to the cassette from bags. Filtering pressure measurements to remove rapid fluctuations determines an accumulated pressure in the patient cavity. The volume of fluid in the patient cavity correlates to the accumulated pressure.