Guidewire Distal Segment Composite Design

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Solution Overview

Problem

Guidewires face challenges in achieving a combination of good torqueability, shape retention, and softness at the distal segment, as a soft distal segment typically lacks torqueability and shape retention due to its material properties.

Innovation Solution

A guidewire design featuring a shaft with multiple layers, including a proximal segment made from high shear modulus materials like Molybdenum Rhenium alloy and a distal segment with Nitinol, along with a sleeve and a marker coil, allowing for desirable torqueability, pushability, and shape retention while maintaining a soft distal segment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the distal segment is made soft to prevent injury and allow elastic flexing, then the guidewire can safely navigate passages of different shapes, but the torqueability and shape retention ability deteriorate

Engineering Contradiction:
Improveinjury preventionVSAvoidtorqueability and shape retention
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The distal segment uses a composite structure combining a soft outer layer (polymer or coated metal) with a rigid inner core (metal wire). This composite design allows the outer layer to provide softness and flexibility for safe navigation, while the inner core maintains torqueability and shape retention capability

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The guidewire is divided into multiple segments with different material properties: the distal segment has a soft outer layer over a rigid core, while proximal segments have different compositions optimized for torque transmission. This segmentation allows each segment to optimize its specific function without compromising overall performance

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If the distal segment is made soft to allow elastic flexing through passages, then adaptability to different anatomical shapes improves, but the shape retention ability worsens

Engineering Contradiction:
Improveflexibility through passagesVSAvoidshape retention
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The soft outer layer (polymer or coated metal) provides adaptability and elastic flexing through passages, while the rigid inner metal core provides shape retention. The composite structure ensures the guidewire can navigate complex anatomical paths while maintaining its bent shape during use

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

Different portions of the guidewire have different material properties: the distal segment has a soft outer layer for flexibility and adaptability, while the inner core and proximal segments have rigid properties for shape retention and torque transmission. This local differentiation allows simultaneous achievement of flexibility and shape retention

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If the distal segment is made soft to prevent injury to the patient, then safety improves, but the torqueability worsens due to material softness

Engineering Contradiction:
Improvepatient injury preventionVSAvoidtorqueability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The soft outer layer (polymer or coated metal) prevents patient injury by providing a compliant surface, while the rigid inner metal core transmits torque effectively. This composite material approach resolves the contradiction between softness for safety and rigidity for torqueability

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 optimal torqueability, pushability, and shape retention, enabling effective navigation through complex anatomical passages without causing injury, with the distal segment being both flexible and capable of retaining a bent shape.

Implementation Method 1

a radiopaque coil surrounding at least a part of the segment

Methodology Applied
Scientific EffectRadiopacity: Absorption (EM radiation)

Implementation Method 2

the part of the segment having opposite sides with indentations along each of the opposite sides for allowing the radiopaque coil to be screwed over the part of the segment

Methodology Applied
Scientific EffectMechanical fastening: Mechanical Fastener

Data Source

PatentEP4233971B1Guidewires for medical devices
Publication Date: 2024.11.06 STRYKER CORP
  • EP4233971B1 patent drawingFigure 1A~1C
  • EP4233971B1 patent drawingFigure 1D~1F
  • EP4233971B1 patent drawingFigure 2A~2C

AI summary

A guidewire includes: a shaft having a proximal end, a distal end, and a body extending from the proximal end to the distal end; a blunt tip; and a sleeve; wherein the body of the shaft comprises at least a segment that is surrounded by the sleeve, the segment coupled to the blunt tip; and wherein the segment of the body of the shaft comprises a flat portion having one or more openings extending through a thickness of the flat portion.