Segmented Medical Guidewire Resilient Tip Design

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Solution Overview

Problem

Conventional guidewires face a dilemma between stiffness for pushability and flexibility, with stainless steel cores being prone to kinking and Nitinol cores lacking sufficient stiffness for maneuverability, leading to potential vessel damage and limited access in complex vascular paths.

Innovation Solution

A guidewire design featuring a solid stainless steel core with a tapered distal section and an overlapping superelastic Nitinol or Nitinol-based resilient portion, which increases flexibility and pushability while minimizing kinking, allowing for predictable steering and repeated use without reshaping or replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a full stainless steel core is used to provide stiffness for pushability, then the guidewire can push through vasculature effectively, but the thinner distal tip tends to kink when bending

Engineering Contradiction:
Improvestiffness for pushabilityVSAvoidkinking resistance
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The guidewire is divided into distinct segments with different material properties: a proximal stainless steel core for stiffness and pushability, and a distal Nitinol resilient portion for flexibility and kink resistance. This segmentation allows each section to perform its optimal function without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guidewire combines two different materials (stainless steel and Nitinol) with complementary properties into a single composite structure. The stainless steel provides structural integrity and pushability, while the Nitinol portion provides superelasticity and resistance to kinking, creating a guidewire that exhibits both stiffness and flexibility.

Inventive Principle:
Principle #40Composite materials

2Adaptability or versatility

If the distal tip is made thinner to improve flexibility and reduce vessel damage, then the guidewire can navigate tortuous paths better, but it becomes more prone to kinking

Engineering Contradiction:
Improveflexibility for navigationVSAvoidkinking resistance
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

Different sections of the guidewire are assigned different material qualities: the distal tip uses Nitinol with superelastic properties specifically where flexibility and kink resistance are needed, while the proximal section uses stainless steel for stiffness. This local differentiation allows the thin distal tip to be both flexible and resistant to kinking.

Inventive Principle:
Principle #3Local quality

3Stability of the object's composition

If a stainless steel core is used to maintain structural integrity, then the guidewire has good torque control, but it lacks flexibility for navigating complex vascular paths

Engineering Contradiction:
Improvestructural integrityVSAvoidflexibility for navigation
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The guidewire structure is segmented into a proximal stainless steel core for structural integrity and torque control, and a distal Nitinol resilient portion for flexibility and adaptability. This allows the guidewire to maintain structural stability while navigating complex vascular anatomy.

Inventive Principle:
Principle #1Segmentation

4Object-affected harmful factors

If the distal tip is made thinner to reduce vessel damage, then the guidewire is more flexible, but it requires more frequent replacement due to kinking

Engineering Contradiction:
Improvevessel damage riskVSAvoidguidewire reuse capability
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The composite construction with Nitinol at the distal tip provides superelastic properties that prevent permanent kinking, allowing the guidewire to be repeatedly bent and shaped during procedures without requiring replacement. This maintains the thin profile needed for vessel safety while enabling repeated use.

Inventive Principle:
Principle #40Composite materials

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 guidewire achieves enhanced pushability and flexibility, reducing the risk of kinking and vessel damage, enabling more effective navigation through tortuous vascular paths with improved maneuverability and reduced fluoroscopy exposure.

Implementation Method 1

an overlapping superelastic Nitinol or Nitinol-based resilient portion

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentEP3434310B1Resilient tip and method
Publication Date: 2023.06.21 HERAEUS MEDICAL COMPONENTS LLC
  • EP3434310B1 patent drawingFigure 1~2
  • EP3434310B1 patent drawingFigure 3
  • EP3434310B1 patent drawingFigure 4~5

AI summary

One aspect is a medical guidewire (10) including a core wire (12) with a proximal end (18) extending out to a distal end (16) and a resilient portion (14) coupled to the distal end of the core wire at a distal tip section of the guidewire. The resilient portion includes a superelastic material.