Split-tip Hemodialysis Catheter Divergence for Clot Prevention

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Solution Overview

Problem

Split-tip dialysis catheters face complications such as blood recirculation, flow occlusion, and increased clotting due to their design, particularly at the junction area where slow and turbulent flow occurs, leading to clot formation and associated morbidity.

Innovation Solution

A dual-tip catheter design where the first and second lumens split at a distal junction and diverge along a splitting plane to regain a relaxed configuration, allowing for elastic divergence and alignment, reducing the risk of clot formation by minimizing stagnant flow and using removable aligning means to facilitate scissor-like movement and optimal positioning within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the two lumens are separated directly away from each other at the junction, then the catheter can withdraw and deliver blood effectively, but a dead space with slow and turbulent flow forms which makes clot formation very likely

Engineering Contradiction:
Improveblood withdrawal and delivery efficiencyVSAvoidclot formation at junction
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a third spatial dimension by angling the lumens relative to the longitudinal axis. Instead of separating lumens in a straight line (1D), they diverge at angles (e.g., 45 degrees) creating a 3D configuration that eliminates dead space while maintaining effective blood flow pathways, thus preventing clot formation without compromising productivity

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

Solution Approach 2:

The patent employs an elastic member that allows the lumens to dynamically adjust their configuration. The elastic member enables the lumens to move from a collapsed state during insertion to a separated state during operation, and can adapt to prevent clot formation while maintaining blood flow efficiency throughout the procedure

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If the catheter tip has freedom of movement inside the patient, then the catheter can be positioned flexibly, but this can cause positional occlusion where the tip or side hole is sucked against the blood vessel or heart wall

Engineering Contradiction:
Improvecatheter positioning flexibilityVSAvoidpositional occlusion
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the catheter into segmented components including a proximal portion, a junction, and distal portions with lumens. This segmentation allows independent movement and positioning of each segment, providing flexibility for proper placement while reducing the risk that the entire tip will be suctioned against the vessel wall, as the segmented structure can flex and adapt to prevent occlusion

Inventive Principle:
Principle #1Segmentation

3Ease of manufacture

If the distal portions of the lumens are aligned during insertion, then the catheter can be inserted smoothly, but clot formation is likely at the junction due to slow and turbulent flow

Engineering Contradiction:
Improvecatheter insertion easeVSAvoidclot formation at junction
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates an elastic member that is pre-configured to automatically separate the lumens at the junction once the catheter is inserted. This preliminary action of alignment during insertion is followed by the automatic divergence of lumens driven by the elastic member's properties, ensuring smooth insertion while preventing clot formation without requiring additional manual intervention

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 design minimizes clot formation and flow occlusion, enhancing the stability and effectiveness of dialysis by ensuring blood flow is not stagnant at the junction and reducing the risk of thrombosis, thereby improving catheter functionality and patient outcomes.

Implementation Method 1

an elastic member, having a non-stressed form in which the first and second distal portions are separated from alignment with each other to a diverged configuration

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS12151068B2Deploying split-tip hemodialysis catheter in a right atrium
Publication Date: 2024.11.26 PRISTINE ACCESS TECH LTD
  • US12151068B2 patent drawing
  • US12151068B2 patent drawing
  • US12151068B2 patent drawing

AI summary

A split-tip catheter and methods for deploying a split-tip catheter in a right atrium are provided. The catheter is configured with a distal portion including a first and a second distal end regions elastically divergable from alignment along a splitting plane to regain a relaxed configuration. The first distal end region terminates in a first tip having a first forward opening, and the second distal end region terminates in a second tip having a second forward opening. Catheter deployment may include directing the first forward opening generally towards an anterior right atrium wall portion and applying the first forward opening to withdraw blood from the right atrium.