Disposable Dialysis Manifold for Fluid Balancing

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Solution Overview

Problem

Conventional dialysis systems are cumbersome, costly, and require patients to be tethered to a dialysis center for extended periods, with complex and unreliable fluid circuits that increase the risk of leakage and breakage, necessitating a portable and more robust extracorporeal blood processing system capable of operating in both hemodialysis and hemofiltration modes with integrated disposable components.

Innovation Solution

A compact, disposable plastic manifold with integrated blood and dialysate fluidic pathways, sensors, valves, and pumps that supports a disposable dialyzer, allowing for operation in either hemodialysis or hemofiltration modes through the use of two-way valves to direct dialysate flow, and includes a sorbent cartridge for dialysate regeneration in hemodialysis and a fresh dialysate reservoir in hemofiltration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional dialysis systems use multiple tubes and complex fluid circuits, then the system can perform hemodialysis and hemofiltration functions, but the system becomes cumbersome, costly, and unreliable with increased risk of leakage and breakage

Engineering Contradiction:
Improvesystem reliabilityVSAvoidfluid circuit complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple fluid circuits (blood circuit and dialysate circuit) and components (tubes, connectors, valves) into a single integrated disposable apparatus. The blood circuit and dialysate circuit are merged into one unit with integrated flow paths, eliminating the need for separate tube connections and reducing the overall number of components that could leak or break.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The apparatus is segmented into distinct functional modules within a single disposable unit, including separate but integrated blood and dialysate flow paths. This segmentation allows each circuit to be independently designed for its specific function while maintaining overall system integration and reducing interconnection points.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If conventional dialysis systems use installed apparatus in hospitals, then the system can provide comprehensive dialysis treatment, but the system requires patients to be bound to a dialysis center for long durations and lacks portability

Engineering Contradiction:
ImproveportabilityVSAvoidsystem integration
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent merges the entire dialysis system including blood pump, dialysate pump, dialyzer, and fluid circuits into a single portable disposable apparatus that can be operated outside traditional hospital settings. This integration enables the system to be transported and used at home or in mobile clinics while maintaining full dialysis functionality.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The portable apparatus is designed to perform multiple dialysis functions (hemodialysis and hemofiltration) within a single device, making it universally applicable for different treatment protocols without requiring separate specialized equipment for each function.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If conventional dialysis systems use separate blood and dialysate circuits, then the system can perform ultrafiltration and dialysis functions, but the system requires a myriad of tubes that increase leakage and breakage risks

Engineering Contradiction:
Improveleakage preventionVSAvoidnumber of tubes
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges separate blood and dialysate circuits into a single integrated apparatus with internally connected flow paths. The blood circuit and dialysate circuit are combined into one unit where connections are factory-sealed and permanently fixed, eliminating the myriad of separate tube connections that require assembly and are prone to leakage and breakage.

Inventive Principle:
Principle #5Merging (Combining)

4Ease of manufacture

If conventional dialysis systems use traditional fluid circuits, then the system can maintain fluid flow for dialysis, but the system becomes costly and requires frequent replacement of components

Engineering Contradiction:
Improvecost reductionVSAvoidcomponent lifespan
Core Design Contradiction:
Ease of manufactureVSDuration of action of stationary object

Solution Approach 1:

The patent employs a disposable apparatus that is designed for single-use and then discarded, eliminating the need for expensive maintenance and replacement of individual components. The entire apparatus including all tubes, connectors, and fluid circuits is manufactured as a low-cost disposable unit that can be safely discarded after one use, reducing overall system cost.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

The system provides a portable, user-friendly, and reliable extracorporeal blood processing system that simplifies dialysis procedures, reduces equipment complexity, and enhances system robustness by integrating essential components into a single, disposable manifold, enabling efficient removal of toxins and fluid management in both hemodialysis and hemofiltration protocols.

Implementation Method 1

The semi permeable membrane separates the blood from dialysate solution. The impurities from the blood pass through the membrane and into the dialysate solutions primarily by osmotic pressures.

Methodology Applied
Scientific EffectOsmotic pressure: Osmosis

Implementation Method 2

This is accomplished by a process known as ultrafiltration. In this process, fluid is removed from the patient by taking the fluid off through the dialyzer via convection and discarding it. The amount of ultrafiltrate which is removed from the body is normally controlled by the pressure across the semipermeable membrane.

Methodology Applied
Scientific EffectConvection: Convection

Implementation Method 3

allowing for operation in either hemodialysis or hemofiltration modes through the use of two-way valves to direct dialysate flow

Methodology Applied
Scientific EffectValve flow direction: Valve

Data Source

PatentUS11439738B2Methods and Systems for fluid balancing in a dialysis system
Publication Date: 2022.09.13 FRESENIUS MEDICAL CARE HOLDINGS INC
  • US11439738B2 patent drawing
  • US11439738B2 patent drawing
  • US11439738B2 patent drawing

AI summary

An extracorporeal blood processing system comprises a plastic molded compact manifold that supports a plurality of molded blood and dialysate fluidic pathways along with a plurality of relevant sensors, valves and pumps. A disposable dialyzer is connected to the molded manifold to complete the blood circuit of the system. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine.