Annealed Polycarbonate-Urethane Sheath Kink Resistance

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Solution Overview

Problem

Existing medical articles such as catheters and sheaths often kink when bent, disrupting fluid flow and hindering performance, and are prone to re-kinking at smaller angles, limiting their flexibility and resilience during insertion and use.

Innovation Solution

A method involving the extrusion of polycarbonate-urethane copolymers, followed by annealing at 248° F for one hour to increase flexibility and reduce rigidity, allowing the medical articles to bend up to 120° without kinking, and incorporating a hub and tip formation for improved functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing sheaths and catheters are made with standard rigidity, then they maintain structural integrity, but they kink when bent to certain radii of curvature disrupting fluid flow

Engineering Contradiction:
Improvefluid flow continuityVSAvoidflexibility during manipulation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by heat treating the polymer at temperatures between 150°C and 250°C to permanently alter its physical properties. This heat treatment modifies the polymer's glass transition temperature and reduces its rigidity, enabling the catheter to bend to smaller radii of curvature without kinking while maintaining structural integrity for reliable fluid flow.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite materials by selecting polymers with specific properties (such as polycarbonate-urethane copolymers) and combining heat treatment with the material's inherent viscoelastic properties. This creates a composite system where the heat-treated polymer exhibits both flexibility for manipulation and structural integrity for maintaining fluid flow continuity.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If the catheter is made more flexible to allow manipulation, then ease of insertion improves, but the catheter becomes prone to re-kinking at smaller angles

Engineering Contradiction:
Improveflexibility during insertionVSAvoidresistance to re-kinking
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by performing heat treatment on the polymer before the catheter is used in the body. This pre-treatment permanently sets the polymer's physical properties to achieve optimal flexibility-resilience balance, allowing the catheter to be easily manipulated during insertion while resisting re-kinking during use without requiring additional adjustments.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the polymer rigidity is reduced to increase flexibility, then the catheter can bend more easily, but the structural strength decreases

Engineering Contradiction:
ImproveflexibilityVSAvoidstructural integrity
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent precisely controls parameter changes by heat treating the polymer within specific temperature ranges (150°C to 250°C) and time periods (30 minutes to 24 hours). This controlled parameter change reduces rigidity to achieve flexibility while maintaining sufficient structural strength, as evidenced by the catheter's ability to withstand pressures up to 300 psi and flow rates up to 130 ml/min.

Inventive Principle:
Principle #35Parameter changes

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 provides medical articles with enhanced flexibility, memory, kink-resistance, and resilience, enabling them to withstand pressures up to 300 psi and flow rates of 130 ml/min without kinking, improving their performance and comfort during insertion and use.

Implementation Method 1

heat treating the flexible medical article by annealing under conditions of, for example, 248° F. for one hour

Methodology Applied
Scientific EffectAnnealing: Annealing

Implementation Method 2

heat treating the tubular shaft by annealing under conditions of, for example, 248° F. for one hour

Methodology Applied
Scientific EffectHeat treatment: Heat Treatment

Implementation Method 3

the polymer is selected have the property of reduced rigidity (i.e., increased flexibility) when exposed to heat

Methodology Applied
Scientific EffectThermal softening:

Data Source

PatentUS9981113B2Flexible medical article and method of making the same
Publication Date: 2018.05.29 ICU MEDICAL INC
  • US9981113B2 patent drawing
  • US9981113B2 patent drawing
  • US9981113B2 patent drawing

AI summary

A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.