Stiffness-Varying IV Needle with Temperature Sensing

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Solution Overview

Problem

Current IV needles are rigid, leading to mechanical mismatch with soft tissue, causing potential damage, inflammation, and needle blockages during patient movement, and pose a safety risk for medical personnel due to reusability and rigidity.

Innovation Solution

A stiffness-varying IV needle that converts from a rigid to a soft form at body temperature, featuring a hollow elongated body member with variable stiffness and a biocompatible coating, and an embedded temperature sensor for monitoring core body temperature and detecting drug leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a rigid IV needle is used, then the needle can be easily inserted into the blood vessel, but it causes mechanical mismatch with soft tissue leading to damage, inflammation, and needle blockages during patient movement

Engineering Contradiction:
Improveease of insertionVSAvoidtissue compatibility
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The IV needle employs a shape memory alloy body that dynamically changes its mechanical properties in response to temperature changes. The needle transitions from a rigid state at room temperature (facilitating easy insertion) to a flexible state at body temperature (ensuring tissue compatibility and preventing damage during patient movement). This dynamic adaptation resolves the contradiction between ease of insertion and tissue compatibility.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The needle's stiffness parameter is changed by utilizing the phase transition characteristics of shape memory alloy. At room temperature, the alloy maintains a martensitic phase with low stiffness for easy insertion. Upon exposure to body temperature, it transforms to an austenitic phase with higher stiffness that adapts to tissue mechanics, preventing tissue damage and inflammation while maintaining reliable drug delivery.

Inventive Principle:
Principle #35Parameter changes

2Strength

If a rigid needle is used, then the needle maintains structural integrity, but it poses safety risk for medical personnel due to reusability and rigidity

Engineering Contradiction:
Improvestructural integrityVSAvoidneedle stick injury risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The IV needle is designed as a disposable single-use device with integrated temperature sensing capability. The shape memory alloy body maintains sufficient structural integrity for its intended use but is discarded after one use, eliminating the risk of needle stick injuries to medical personnel from reused needles. The disposable nature combined with real-time temperature monitoring ensures both safety and reliability.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The needle incorporates an embedded temperature sensor that autonomously monitors the needle's temperature and detects improper reuse attempts. The sensor provides real-time feedback about the needle's thermal state, alerting medical personnel if the needle is being reused or mishandled, thereby preventing needle stick injuries without requiring additional external monitoring systems.

Inventive Principle:
Principle #25Self-service

3Stability of the object's composition

If a rigid needle is used, then the needle maintains its shape, but it creates large gap in mechanical property with soft biological tissue causing tissue inflammation and needle blockage

Engineering Contradiction:
Improveshape stabilityVSAvoidtissue inflammation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The needle utilizes shape memory alloy technology to dynamically adjust its mechanical properties matching the tissue environment. At room temperature, the needle maintains shape stability for precise insertion. Upon contact with body temperature tissue, the alloy transforms to a more compliant state that adapts to the soft biological tissue, eliminating mechanical mismatch, preventing tissue inflammation, and avoiding needle blockage while maintaining adequate shape definition for drug delivery.

Inventive Principle:
Principle #15Dynamics

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 needle maintains stability during drug delivery without damaging blood vessels, prevents needle-related accidents by being non-reusable, and enhances patient safety and medical service efficiency.

Implementation Method 1

a body member implemented in a hollow elongated shape through which drug passes and having a variable stiffness according to body temperature

Methodology Applied
Scientific EffectBody temperature-responsive stiffness variation: Thermal Expansion

Data Source

PatentUS20240335640A1Body temperature-responsive, stiffness-varying and non-reusable intravenous needle with on-site temperature sensing for improved patient care, intravenous infusion set having the same, and manufacturing method of the same
Publication Date: 2024.10.10 KOREA ADVANCED INST OF SCI & TECH
  • US20240335640A1 patent drawing
  • US20240335640A1 patent drawing
  • US20240335640A1 patent drawing

AI summary

Provided are a body temperature-responsive and non-reusable stiffness-varying intravenous (IV) needle with an on-site temperature sensing function, an IV infusion set having the same, and a manufacturing method thereof. The stiffness-varying IV needle may include a body member implemented in a hollow elongated shape through which drug passes and having a variable stiffness according to ambient temperature; and a coating member configured to cover the outer surface of the body member and having biocompatibility.