Expandable Tip Guidewire Radial Force Distribution

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Solution Overview

Problem

Existing guidewires cause trauma and vessel damage during catheter exchange procedures due to excessive movement and inadequate force distribution, particularly in delicate vasculature, as traditional tips like the J-tip do not effectively distribute force and can lead to irritation, spasm, dissection, or perforation.

Innovation Solution

A guidewire with a compliant structure at the distal end that expands radially upon deployment, providing a uniform outward force and anchoring within the vessel to minimize trauma and stabilize the guidewire, allowing for safer catheter exchange by distributing force and reducing unwanted motion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a traditional J-tip guidewire is used, then the guidewire can be easily navigated through vasculature, but it causes vessel trauma, irritation, spasm, dissection, or perforation due to concentrated force at the tip

Engineering Contradiction:

Improveguidewire navigationVSAvoidvessel trauma

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The guidewire tip is segmented into multiple elements (struts, beams, or wires) arranged in a compliant structure. This segmentation distributes the contact force from the guidewire tip across multiple points of contact with the vessel wall, rather than concentrating force at a single J-tip point, thereby reducing vessel trauma while maintaining navigability

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The distal portion of the guidewire is given different local properties than the proximal portion. The distal compliant structure is designed to be more flexible and compliant to conform to vessel walls and distribute force, while the proximal portion maintains sufficient stiffness for manipulation. This local differentiation allows the guidewire to navigate easily while minimizing trauma at the critical tip region

Inventive Principle:

Principle #3Local quality

2Object-affected harmful factors

If the guidewire tip is curved to reduce trauma, then some trauma reduction is achieved, but force distribution remains insufficient and vessel damage risk persists

Engineering Contradiction:

Improvevessel traumaVSAvoidforce distribution effectiveness

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The compliant structure divides the tip into multiple discrete elements (struts, beams, or wires) that can independently contact the vessel wall. This segmentation ensures that force is distributed across multiple contact points along the curved structure, providing more reliable and uniform force distribution compared to a simple J-curve, thereby reducing vessel trauma more effectively

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The guidewire employs composite construction with different materials having varying stiffness properties. The distal compliant structure uses more flexible materials (such as nitinol or shape memory alloys) compared to the stiffer proximal portion, creating a gradient that enhances force distribution while maintaining the curved shape. This material composite approach improves reliability of force distribution and trauma reduction

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If exchange length guidewire is used for catheter exchange, then catheter replacement is facilitated, but excessive movement of the guidewire tip causes vessel irritation or damage

Engineering Contradiction:

Improvecatheter exchangeVSAvoidvessel irritation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The guidewire tip is designed with dynamic compliance that allows it to adapt its stiffness characteristics during catheter exchange. The compliant structure can flex and conform to vessel movements during the exchange procedure, absorbing unintended motions that would otherwise cause vessel irritation. This dynamic behavior enables safe catheter exchange while protecting the vessel from trauma

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The guidewire exhibits parameter changes in its mechanical properties along its length and during operation. The distal compliant portion has lower stiffness parameters that allow it to accommodate vessel movements and reduce trauma during catheter exchange, while the proximal portion maintains higher stiffness for operator control. This parameter differentiation enables both easy catheter exchange and vessel protection

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 compliant guidewire structure significantly reduces vessel trauma and improves catheter exchange by distributing force evenly, minimizing the risk of damage and facilitating smoother navigation and anchoring during procedures.

Implementation Method 1

a guidewire with a compliant structure at the distal end that expands radially upon deployment, providing a uniform outward force

Methodology Applied

Scientific EffectRadial expansion:

Implementation Method 2

distributing force evenly, minimizing the risk of damage

Methodology Applied

Scientific EffectForce distribution:

Implementation Method 3

anchoring within the vessel to minimize trauma and stabilize the guidewire

Methodology Applied

Scientific EffectAnchoring:

Implementation Method 4

The compliant guidewire structure significantly reduces vessel trauma and improves catheter exchange by distributing force evenly

Methodology Applied

Scientific EffectFriction: Friction

Data Source

PatentUS11497895B2Expandable tip medical devices and methods

Publication Date: 2022.11.15 COVIDIEN LP

AI summary

Guidewires and methods of use of guidewires having improved atraumatic tips that can distribute force to lessen trauma as well as anchor the guidewire to facilitate improved catheter exchange.