Self-Cleaning Shunt Catheter Split Tip Design

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Solution Overview

Problem

Shunt systems for hydrocephalus treatment often become clogged due to foreign materials in the narrow passageways, necessitating costly and risky follow-on operations for maintenance or replacement.

Innovation Solution

Self-cleaning catheters with split tips that utilize pulsatile flow to clear obstructions and built-in flow indicators visible under MRI, along with flushing systems that include collapsible domes and adjustable valves to facilitate obstruction removal and auxiliary pathway opening.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If a narrow tubular passageway is used in the shunt system, then the device size is reduced and implantation is easier, but the passageway becomes prone to clogging by foreign materials

Engineering Contradiction:
Improvedevice sizeVSAvoidclogging resistance
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

The catheter tip is divided into multiple segments or lobes (e.g., Y-shaped, T-shaped, or multi-lobed configurations) that create multiple separate fluid passageways. This segmentation prevents foreign materials from blocking the entire fluid pathway, as obstructions in one segment do not prevent flow through other segments, thereby maintaining reliability while keeping the overall device size compact.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter tip transitions from a simple linear tubular structure to a three-dimensional multi-lobed or branched configuration. This dimensional change creates multiple spatial pathways for fluid flow, allowing the catheter to maintain a small overall footprint while providing redundant flow paths that resist clogging by distributing foreign materials across multiple channels.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Device complexity

If a simple catheter structure is used, then the device complexity is reduced and manufacturing is easier, but the ability to detect blockages and perform maintenance is limited

Engineering Contradiction:
Improvecatheter structureVSAvoidblockage detection and maintenance
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The catheter incorporates flow indicators that change their physical state or appearance based on flow conditions. These indicators may include radiopaque markers visible on X-rays, MRI-visible materials, or flow-sensitive elements that move or change position to indicate whether fluid is flowing freely or if a blockage has occurred, enabling non-invasive monitoring of catheter patency.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The catheter incorporates self-cleaning mechanisms such as pulsatile flow capability or reversible flow direction that allow the system to clear its own obstructions without requiring surgical intervention. The design enables the catheter to maintain its own functionality by using the fluid flow itself to prevent or remove clogs, reducing the need for complex external maintenance systems.

Inventive Principle:
Principle #25Self-service

3Duration of action of stationary object

If the shunt system is designed for long-term implantation, then the duration of action is extended, but the accumulation of foreign materials increases the risk of clogging

Engineering Contradiction:
Improveimplantation durationVSAvoidclogging resistance
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The catheter design incorporates features that facilitate the removal of accumulated foreign materials over time. This may include accessible ports for flushing, detachable sections that can be replaced, or surfaces that prevent permanent adhesion of debris. The system allows for periodic maintenance or recovery of functionality without requiring complete replacement of the entire implant, thereby extending reliable operation duration.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The catheter incorporates preventive features designed to stop clogging before it occurs. This includes anti-adhesive surface coatings, initial flushing protocols, or design features that prevent foreign materials from adhering to the catheter walls in the first place. By taking preliminary actions to prevent obstruction, the system maintains reliability over extended implantation periods.

Inventive Principle:
Principle #10Preliminary action

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 solution effectively reduces the need for frequent maintenance by automatically clearing obstructions and providing reliable blockage detection, thereby minimizing complications and costs associated with shunt system clogging.

Implementation Method 1

Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions

Methodology Applied
Scientific EffectPulsatile flow:

Implementation Method 2

Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI

Methodology Applied
Scientific EffectMRI imaging:

Implementation Method 3

a valve having a first position in which the flush dome is not in fluid communication with the upstream port or the passive flow path and a second position in which the flush dome is in fluid communication with the upstream port and the passive flow path; wherein application of a force to the pinch tube is effective to collapse the pinch tube to block the passive flow path and to collapse the dome to move the valve to the second position and flush fluid through the upstream port

Methodology Applied
Scientific EffectMechanical collapse:

Implementation Method 4

an auxiliary fluid inlet port covered by a membrane such that fluid external to the catheter cannot flow through the auxiliary inlet port; and the membrane can be configured to rupture when a predetermined threshold force is applied to the membrane by fluid in the inner lumen of the catheter to open the auxiliary fluid inlet port

Methodology Applied
Scientific EffectMembrane rupture:

Data Source

PatentEP3679977B1Systems for shunting fluid
Publication Date: 2023.09.06 ANUNCIA MEDICAL INC
  • EP3679977B1 patent drawingFigure 1
  • EP3679977B1 patent drawingFigure 2~3
  • EP3679977B1 patent drawingFigure 4~5

AI summary

Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked. Systems and methods for flushing a shunt system are also disclosed herein, as are various systems and methods for opening auxiliary fluid pathways through a shunt system.