Hemodiafiltration Module Safety Control via Flow Feedback

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing dialysis machines often fail to coordinate safely between events like alarm conditions and mode shifts, leading to potentially hazardous conditions when the substitution pump continues to operate without dialysate or blood flow, particularly in hemodiafiltration treatments.

Innovation Solution

A hemodiafiltration delivery module that integrates with ultrafiltration-controlled dialysis machines, using a sterilizing filter cartridge and pressure sensors to monitor dialysate and blood flow, ensuring safe operation by controlling the substitution pump and preventing hemoconcentration, with a configuration that allows for easy integration and reduced maintenance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a substitution pump is used to deliver substitution fluid during hemodiafiltration, then the removal of substances from blood is enhanced, but hazardous conditions occur when the pump continues to operate without dialysate or blood flow

Engineering Contradiction:
Improvesubstance removal efficiencyVSAvoidsafe operation
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system employs feedback control by monitoring dialysate flow rate and blood flow rate through sensors, and using this information to automatically adjust or stop the substitution pump operation. When dialysate flow rate or blood flow rate falls below predetermined thresholds, the control unit stops the substitution pump to prevent hazardous conditions such as hemoconcentration.

Inventive Principle:
Principle #23Feedback

2Reliability

If multiple sensors are used to monitor flow conditions, then safe operation is ensured, but device complexity increases

Engineering Contradiction:
Improvesafe operationVSAvoidnumber of sensors
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The control unit is designed to serve multiple functions: it monitors both dialysate flow rate and blood flow rate, determines operational parameters for the substitution pump, and executes control decisions based on sensor inputs. This multi-functional design reduces the need for separate dedicated components for each monitoring task.

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

3Ease of manufacture

If a hemodiafiltration module is integrated with existing dialysis machines, then the need for new expensive equipment is reduced, but coordination safety between machine events becomes problematic

Engineering Contradiction:
Improveequipment costVSAvoidcoordination safety
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The hemodiafiltration delivery module acts as an intermediary system that interfaces with the host dialysis machine. It receives operational information from the machine (such as alarm conditions and mode shifts) and independently controls the substitution pump based on its own sensor measurements, thereby mediating between the machine's control system and the substitution fluid delivery to ensure safety.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables safe and efficient hemodiafiltration therapy using existing dialysis machines, preventing hazardous conditions and reducing the need for new equipment, while minimizing maintenance and operational complexity.

Implementation Method 1

a sterilizing filter cartridge containing at least one filtration stage is used to filter the non-sterile dialysate solution and thus render it sterile and non-pyrogenic

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

pressure sensors to monitor dialysate and blood flow

Methodology Applied
Scientific EffectPressure sensing: Pressure Gradient

Implementation Method 3

The removal of substances by diffusion is accomplished by establishing a concentration gradient across a semipermeable membrane by flowing a dialysate solution on one side of the membrane while simultaneously flowing blood on the opposite side of the membrane

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

a dialyzer cartridge containing a high flux membrane is used to remove substances from the blood both by diffusion and by convection

Methodology Applied
Scientific EffectConvection: Convection

Data Source

PatentUS10821216B1Method and apparatus for a hemodiafiltration module for use with a dialysis machine
Publication Date: 2020.11.03 NEPHROS INC
  • US10821216B1 patent drawing
  • US10821216B1 patent drawing
  • US10821216B1 patent drawing

AI summary

A method and apparatus are provided for a hemodiafiltration delivery module that is used in conjunction with a UF controlled dialysis machine to enable hemodiafiltration therapy to be performed. The advantage is that one can fully utilize a current functioning dialysis machine to perform a hemodiafiltration therapy as opposed to purchasing a completely new machine that offers this capability.