Valved Tip Catheter Segmentation for Thrombus Prevention

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Solution Overview

Problem

Chronic catheters face issues with thrombus formation due to anticoagulant leakage and blood ingress during non-use periods, leading to thrombosis and potential catheter failure, which is costly and invasive to treat.

Innovation Solution

A split-tip catheter design with distal and proximal one-way valves that are normally closed, allowing fluid to exit and enter respectively based on pressure differentials, minimizing recirculation and retaining anticoagulant within the catheter lumens without the need for locking solutions like heparin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional catheter without valves is used, then the catheter structure is simple, but anticoagulant leaks from the distal end and blood enters during non-use periods, causing thrombus formation

Engineering Contradiction:
Improveprevention of thrombus formationVSAvoidcatheter structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter tip is divided into multiple separate tip portions (first distal tip portion and second distal tip portion) that are spaced apart. This segmentation allows each tip portion to have its own valve assembly, enabling independent control of fluid flow at each opening and preventing blood ingress while maintaining catheter functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Valve assemblies are introduced as intermediary components between the catheter lumen and the external environment. These valves selectively control fluid flow, allowing anticoagulant to be retained within the lumen while preventing blood from entering, thereby resolving the contradiction between simple structure and thrombus prevention.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If anticoagulant is injected to fill the lumen during locking, then thrombus formation is inhibited, but anticoagulant partially drains from the distal end allowing blood to enter and form thrombus

Engineering Contradiction:
Improvethrombus preventionVSAvoidanticoagulant drainage
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The valve assemblies provide self-service functionality by automatically responding to pressure differentials. When the catheter is locked and anticoagulant fills the lumen, the valves remain closed to the external environment, preventing anticoagulant drainage and blood ingress without requiring external intervention or monitoring.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The valve assemblies act as intermediaries that selectively control the interface between the catheter lumen and external environment. They prevent anticoagulant loss while allowing the catheter to maintain its locked state, thereby preventing thrombus formation without continuous drainage issues.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the catheter tip is separated into multiple portions, then recirculation is minimized and valve placement is optimized, but the manufacturing complexity increases

Engineering Contradiction:
Improverecirculation preventionVSAvoidcatheter fabrication
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The catheter tip is segmented into multiple separate tip portions with valve assemblies positioned between them. This segmentation minimizes recirculation by ensuring that fluid exiting one tip portion does not immediately re-enter through another. The segmented design, while slightly more complex to manufacture, can be achieved through standard catheter fabrication techniques involving modular assembly.

Inventive Principle:
Principle #1Segmentation

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 catheter effectively prevents thrombus formation by maintaining anticoagulant within the lumens and preventing blood ingress, reducing the risk of thrombosis and extending catheter lifespan without the use of expensive treatments like tPA.

Implementation Method 1

each of the distally located one-way valves being configured to open in response to an increase in pressure within a respective one of the first and second lumens to enable fluid to be discharged from the respective first or second lumen; and a proximally located normally closed, one-way valve associated with each of the first and second lumens... being configured to open in response to a decrease in pressure within a respective one of the first and second lumens to enable fluid to enter the respective first or second lumen

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentEP2682152B1Valved tip catheters
Publication Date: 2019.09.18 COVIDIEN LP
  • EP2682152B1 patent drawingFigure 1
  • EP2682152B1 patent drawingFigure 2~3B
  • EP2682152B1 patent drawingFigure 3C~3D

AI summary

The present disclosure relates to multiple embodiments of catheters (100, 200, 300, 400, 600, 700, 800) which include valved openings (118, 120, 218, 220, 318, 320, 418, 420, 618, 620, 718, 720, 818, 820) which are normally closed to maintain a lock solution within a catheter during periods of non-use.