Sustained-Release Refreshing Stylet for Catheter Thrombosis Prevention
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Solution Overview
Problem
Current treatments for preventing catheter-related thrombosis and fibrin-sheath formation, such as using locking solutions like sodium citrate or heparin, lose efficacy over time, necessitating a more consistent delivery of antithrombotic agents to catheter lumens.
Innovation Solution
A refreshing stylet with a sustained-release formulation coated on its exterior surface, featuring side holes for locking solution distribution, is inserted into the catheter lumen to provide continuous antithrombotic treatment, using agents like nitric oxide, TPA, or heparin, which can be controllably released to prevent thrombus formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If locking solutions like sodium citrate or heparin are used to prevent catheter-related thrombosis, then thrombosis prevention is improved, but the solutions lose efficacy over time requiring replacement or additional treatment
Solution Approach 1:
The patent applies preliminary action by coating the stylet with sustained-release antithrombotic formulation before insertion into the catheter lumen. This pre-prepared coating ensures that antithrombotic agents are immediately available upon contact with the catheter wall, establishing protective action before thrombosis can occur during the locking solution's limited efficacy period.
Solution Approach 2:
The patent implements continuity of useful action through the sustained-release formulation that continuously delivers antithrombotic agents over an extended period. The controlled release mechanism maintains therapeutic concentrations of antithrombotic agents throughout the catheter lumen, ensuring uninterrupted protection against thrombosis formation during the entire locking solution duration and beyond.
2Reliability
If catheter lumens are treated with locking solutions between dialysis sessions, then fibrin-sheath formation is reduced, but the treatment requires frequent monitoring and potential re-treatment
Solution Approach 1:
The patent applies self-service by designing a system where the stylet with sustained-release coating automatically and continuously delivers antithrombotic agents without requiring external intervention. Once inserted, the stylet autonomously maintains therapeutic drug levels in the catheter lumen through its built-in sustained-release mechanism, eliminating the need for frequent manual monitoring and re-treatment by healthcare providers.
3Duration of action of moving object
If sustained-release formulation with antithrombotic agents is applied to the stylet exterior surface, then consistent antithrombotic delivery is achieved, but device complexity increases
Solution Approach 1:
The patent applies parameter changes by modifying the physical and chemical properties of the stylet surface through coating with sustained-release formulation. The coating alters the release kinetics, surface area for drug delivery, and concentration gradients of antithrombotic agents, enabling controlled and consistent drug delivery over extended periods while maintaining the simple rod-like structure of the stylet itself.
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 refreshing stylet effectively maintains antithrombotic protection for 24-72 hours, ensuring consistent prevention of thrombosis and fibrin-sheath formation by continuously delivering antithrombotic agents to the catheter lumens.
Implementation Method 1
The exterior surface is coated with a sustained-release formulation including one or more anti-thrombotic agents. The sustained-release formulation is configured to contact a luminal surface of the catheter and prevent thrombus formation thereon.
Implementation Method 2
The side hole is through the hollow body and connects the interior surface with the exterior surface. The side hole is configured to provide a locking solution to the lumen of the catheter for locking the catheter between uses.
Implementation Method 3
The sustained-release formulation includes the nitric oxide dissolved within the sustained-release formulation such that the nitric oxide controllably off gasses.
Data Source
AI summary
Refreshing stylets, catheter systems, and methods thereof. The refreshing stylet can be configured to fit within a lumen of a catheter such as hemodialysis catheter. The refreshing stylet can include an elongated hollow body having a proximal portion coupled to a needleless connector, a distal portion ending in a distal tip, an interior surface, an exterior surface, and a side hole. The exterior surface can be coated with a sustained-release formulation including one or more anti-thrombotic agents. The sustained-release formulation can be configured to contact a luminal surface of the catheter and prevent thrombus formation thereon. The side hole can be configured to provide a locking solution to the lumen of the catheter for locking the catheter between uses.