Infusate Sleeve with Filter for Dialysis

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Solution Overview

Problem

Current dialysis systems require separate containers for specific solutions like sodium chloride, sodium bicarbonate, and cations, which need to be cleaned and sterilized before each use, increasing costs and time, and there is a need for disposable components that can dissolve solid infusates while preventing particulate matter from entering the system.

Innovation Solution

The development of an infusate sleeve with a filter and rigid disk, connected to a draw tube and fluid connector, allowing for the dissolution of solid infusates within a reusable container, ensuring the separation of particulates and efficient delivery of infusate solutions to the dialysate flow path.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If separate containers are used for each solution (sodium chloride, sodium bicarbonate, cations), then the concentration control and purity are improved, but the cleaning and sterilization time and cost increase

Engineering Contradiction:
Improveconcentration control and purityVSAvoidcleaning and sterilization time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system divides the infusate delivery function into separate disposable sleeves, each containing a specific solution (sodium chloride, sodium bicarbonate, or cations). This segmentation allows each sleeve to be independently prepared with precise concentrations while being disposed of after single use, eliminating the need for cleaning and sterilization of reusable containers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs disposable infusate sleeves that are discarded after single use. These sleeves contain pre-measured solutions and are replaced rather than cleaned, significantly reducing the time and cost associated with cleaning and sterilization while maintaining concentration control and purity through factory-prepared formulations.

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

2Measurement precision

If solid infusate sources are dissolved in reusable containers, then the solution concentration can be controlled, but particulate matter may enter the dialysis system

Engineering Contradiction:
Improvesolution concentrationVSAvoidparticulate matter contamination
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The disposable infusate sleeves are factory-filled with pre-dissolved solutions of known concentration. This eliminates the need for on-site dissolution of solid infusate sources, thereby preventing particulate matter contamination while maintaining precise concentration control through manufacturing specifications.

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

Solution Approach 2:

The solutions are pre-dissolved and prepared in the disposable sleeves during manufacturing before use in the dialysis system. This preliminary action ensures that the solutions are ready for immediate use with controlled concentrations and no particulate matter, as the dissolution process occurs in a controlled factory environment rather than in reusable containers that would require cleaning.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If disposable infusate sleeves are used within reusable containers, then cleaning and sterilization frequency is reduced, but the device complexity increases

Engineering Contradiction:
Improvecleaning and sterilization efficiencyVSAvoidcontainer and sleeve assembly structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system separates the infusate storage and delivery function into disposable sleeves that insert into reusable containers. This segmentation simplifies the overall system by allowing the reusable container to remain simple while the disposable sleeve handles the complex function of containing pre-prepared solutions with precise concentrations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reusable container is designed with universal compatibility to accept different types of disposable sleeves (for different solutions). This multi-functionality allows a single reusable container design to serve multiple purposes with different infusate types, reducing device complexity while maintaining high productivity through reduced cleaning needs.

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

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 solution reduces the need for frequent cleaning and sterilization of containers, lowers costs, and ensures consistent infusate concentrations by using disposable infusate sleeves within reusable containers, preventing particulate entry and maintaining solution purity.

Implementation Method 1

a filter inside of the sleeve body and sealed to the sleeve body separating the sleeve body into a top portion and a bottom portion

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

a draw tube connected to the rigid disk; the draw tube downwardly extending from the rigid disk through the filter and into the bottom portion

Methodology Applied
Scientific EffectFluid flow through tube:

Implementation Method 3

a rigid disk sealed to a top portion of the sleeve body; the rigid disk covering an opening in the top portion of the sleeve body

Methodology Applied
Scientific EffectPhysical containment: Physical Containment

Data Source

PatentEP3621672B1Infusate sleeve
Publication Date: 2021.06.30 MEDTRONIC INC
  • EP3621672B1 patent drawingFigure 1
  • EP3621672B1 patent drawingFigure 2
  • EP3621672B1 patent drawingFigure 3

AI summary

The invention relates to infusate sleeves for use in dialysis and related systems and methods. The infusate sleeves include a sleeve body, a filter inside of the sleeve body, a rigid disk covering an opening in the top of the sleeve body, a draw tube connected to the rigid disk and extending downwardly into the sleeve body, and a fluid connector fluidly connected to the draw tube for connection to a dialysis system.