Guide Wire Deformation Portion Erroneous Puncture Prevention

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Solution Overview

Problem

Current medical devices for puncturing biological tissues, such as the fossa ovalis, face challenges with erroneous punctures and difficulty in forming large diameter holes due to the design of existing guide wires, which can lead to complications like cardiac tamponade and require additional expensive devices.

Innovation Solution

A guide wire with a flexible elongated shaft, a puncture portion, and a deformable deformation portion that restricts deflection, allowing for safe and accurate hole formation in biological tissues without the need for separate puncture devices, by accommodating the puncture portion and covering it after use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a mechanical puncture needle with an angled distal end is used to puncture biological tissue, then the needle can penetrate the tissue, but the needle meets strong resistance when passing through the outer needle and it is difficult to form a large diameter puncture hole

Engineering Contradiction:

Improvepuncture capabilityVSAvoiddifficulty to form large diameter puncture hole

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The guide wire is divided into distinct functional segments: a shaft portion for guidance, a puncture portion with needle for tissue penetration, and a deformation portion for flexibility and protection. This segmentation allows each part to be optimized for its specific function while working together as a unified system.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The guide wire incorporates a deformable portion that can dynamically change its properties. The deformation portion allows the distal end to be flexible during insertion and navigation, then can be straightened or rigidified during the puncture operation to reduce resistance and enable effective hole formation.

Inventive Principle:

Principle #15Dynamics

2Reliability

If the distal end of the inner needle is exposed to facilitate puncture, then the needle can effectively penetrate the biological tissue, but there is a possibility that erroneous puncture may be performed

Engineering Contradiction:

Improvepuncture effectivenessVSAvoiderroneous puncture risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The puncture portion is prepared in advance by being accommodated within the deformation portion during insertion. Before the actual puncture operation, the needle is positioned and the deformation portion is configured to provide protection during navigation, then the needle is exposed only when needed for the controlled puncture action.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The deformation portion serves as an intermediary structure that mediates between the sharp puncture needle and the surrounding environment. It provides a protective sheath during navigation that can be retracted or deformed to expose the needle only when the puncture is intentionally performed, thus preventing erroneous punctures while maintaining puncture effectiveness.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If a bent portion of the inner needle is formed to improve flexibility, then the needle becomes more flexible, but the diameter of the bent portion needs to be decreased which makes it difficult to form a large diameter puncture hole

Engineering Contradiction:

ImproveflexibilityVSAvoiddifficulty to form large diameter puncture hole

Core Design Contradiction:

Ease of operationVSEase of manufacture

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The deformation portion functions as a flexible shell that can deform to accommodate the sharp puncture needle while maintaining structural integrity. This flexible portion allows the distal end to navigate through tortuous pathways, then can be straightened or rigidified during the puncture operation to reduce resistance and enable effective hole formation.

Inventive Principle:

Principle #30Flexible shells and thin films

4Object-affected harmful factors

If a separate puncture device is used to ensure safety and prevent erroneous puncture, then the safety is improved, but the device complexity and cost increase

Engineering Contradiction:

Improveerroneous puncture preventionVSAvoiddevice complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The guide wire combines multiple functions into a single integrated device: it serves as both the guidance wire for navigating the catheter and the puncture needle for creating the access hole. The deformation portion integrates the protective and flexible functions, eliminating the need for separate protective sheaths or additional puncture devices.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The guide wire is designed as a multi-functional device that performs guidance, protection, and puncture functions. The deformation portion can serve as both a protective sheath during navigation and as a delivery mechanism for the puncture needle, while the needle itself serves both as a structural element and as the puncturing element.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11833316B2Guide wire, medical device, and treatment method

Publication Date: 2023.12.05 TERUMO KK

AI summary

A guide wire, a medical device, and a medical method are able to achieve satisfactory workability and while ensuring safety by preventing a puncture needle portion from performing erroneous puncture. A guide wire for guiding a dilator to be inserted into a living body includes a shaft portion, a puncture portion fixed to a distal portion of the shaft portion, and whose distal side includes a needle portion for forming a hole in a biological tissue, and a deformable deformation portion fixed to the shaft portion or the puncture portion. The deformation portion located inside the dilator restricts deflection of the distal portion of the shaft portion.