Nitinol Endovascular Device Sequenced Shape Memory Deployment

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Solution Overview

Problem

Current Nitinol-based endovascular devices face challenges in controlled temperature deployment within the body, as they typically rely on a single austenite finish temperature for shape recovery, making sequenced deployment difficult due to temperature control issues and premature deployment risks.

Innovation Solution

An endovascular device with a Nitinol structural element featuring multiple deployable regions, each with a unique austenite finish temperature above body temperature, allowing for sequenced deployment through selective heating, enabling precise and controlled shape recovery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single austenite finish temperature is used for shape recovery, then the device structure is simple, but sequenced deployment control is lost and premature deployment risk increases

Engineering Contradiction:

Improvedevice structureVSAvoidsequenced deployment control

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The Nitinol structural element is divided into multiple discrete regions, each with a different austenite finish temperature. This segmentation allows each region to deploy at a specific temperature threshold, enabling controlled sequenced deployment while maintaining overall device simplicity

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the Nitinol structural element are assigned different local austenite finish temperatures to achieve specific deployment sequences. This local quality variation enables precise control over which portions of the device deploy at each temperature stage without complicating the overall device structure

Inventive Principle:

Principle #3Local quality

2Reliability

If heating is employed to induce shape recovery at austenite finish temperatures at or above body temperature, then shape recovery can be controlled, but temperature control in situ becomes difficult

Engineering Contradiction:

Improveshape recovery controlVSAvoidtemperature control in situ

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The austenite finish temperatures of different regions are set to specific values above body temperature, creating inherent temperature thresholds that trigger deployment. This parameter variation across regions allows shape recovery control through passive temperature changes without requiring active temperature regulation mechanisms

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The device utilizes the body's natural temperature gradient and passive heating to trigger deployment at predetermined austenite finish temperatures. The different regional temperature thresholds enable self-controlled sequenced deployment without external temperature regulation, simplifying in situ operation

Inventive Principle:

Principle #25Self-service

3Reliability

If multiple deployable regions with different austenite finish temperatures are used, then sequenced deployment is enabled, but manufacturing complexity increases

Engineering Contradiction:

Improvesequenced deploymentVSAvoidmanufacturing process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The different austenite finish temperatures are established during the manufacturing process through preliminary heat treatment of specific regions. This preliminary action creates the temperature gradients needed for sequenced deployment while integrating the complexity into the manufacturing stage rather than requiring complex assembly procedures

Inventive Principle:

Principle #10Preliminary action

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

Enables a fully deployed configuration in a sequenced manner, ensuring precise deployment and maintaining the deployed shape by utilizing distinct austenite finish temperatures for each region, preventing premature deployment and ensuring effective shape recovery.

Implementation Method 1

Nitinol structural element having n deployable regions, where each of the n deployable regions comprises a local austenite finish temperature above body temperature

Methodology Applied

Scientific EffectShape memory alloy phase transformation: Shape Memory Alloy

Implementation Method 2

the transformation from martensite to austenite that is needed for shape recovery

Methodology Applied

Scientific EffectThermal expansion and phase change: Phase Change

Implementation Method 3

The Nitinol structural element is heated above body temperature, during and/or after delivery into the body vessel, and each of the n deployable regions is deployed when the local austenite finish temperature thereof is reached

Methodology Applied

Scientific EffectThermal heating: Heating

Data Source

PatentUS10596016B2Endovascular device configured for sequenced shape memory deployment in a body vessel

Publication Date: 2020.03.24 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A method of sequenced deployment of an endovascular device comprises delivering, into a body vessel, a Nitinol structural element comprising n deployable regions each having a local austenite finish temperature above body temperature. The local austenite finish temperature of at least one of the n deployable regions is different from the local austenite finish temperature of another of the n deployable regions. During and/or after delivery, the Nitinol structural element is heated above body temperature, and each of the n deployable regions is deployed when the local austenite finish temperature thereof is reached. Thus, a deployed configuration of an endovascular device is achieved in a sequenced deployment process.