Self-Sealing Pad for Fluid Isolation in Safety Needle Assemblies

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Solution Overview

Problem

Existing infusion needle assemblies fail to effectively prevent fluid exposure to clinicians, posing a risk of hazardous contact during use.

Innovation Solution

A safety needle assembly with a fluid isolation component and self-sealing pad that shields the needle tip and captures any leaked fluids, preventing exposure through a combination of absorbent materials and retractable mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional needle assembly is used for fluid infusion, then the needle can effectively deliver fluid into the access port, but fluid may leak from the needle and expose the clinician to hazardous substances

Engineering Contradiction:

Improvefluid containmentVSAvoidclinician exposure to hazardous fluid

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A self-sealing pad is introduced as an intermediary component between the needle and the external environment. The pad includes a self-sealing membrane that allows the needle to penetrate and withdraw while maintaining fluid containment, sealing around the needle to prevent hazardous fluid from reaching the clinician.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The self-sealing pad utilizes a flexible thin film membrane that can deform to accommodate needle insertion and withdrawal. The membrane maintains its sealing function throughout the needle's movement, flexing to allow passage while preventing fluid leakage to the external environment.

Inventive Principle:

Principle #30Flexible shells and thin films

2Object-affected harmful factors

If the needle is shielded by the safety assembly to prevent needle sticks, then clinician safety is improved, but fluid may escape through the needle hole in the safety assembly base

Engineering Contradiction:

Improveneedle stick injuryVSAvoidfluid escape from needle

Core Design Contradiction:

Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The self-sealing pad acts as an intermediary barrier positioned at the base of the safety assembly. It allows the needle to pass through during insertion and withdrawal while maintaining fluid containment, preventing hazardous fluid from escaping through the needle hole in the safety assembly base.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The self-sealing pad is pre-positioned on the safety assembly base before needle insertion. It is designed to automatically seal around the needle as it penetrates, establishing fluid containment before any potential leakage can occur during the procedure.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If the self-sealing pad is made highly sealing to prevent fluid leakage, then fluid containment is improved, but the needle may have difficulty penetrating the pad

Engineering Contradiction:

Improvefluid containmentVSAvoidneedle penetration force

Core Design Contradiction:

ReliabilityVSForce

Solution Approach 1:

The self-sealing membrane's physical parameters are optimized to balance sealing effectiveness with needle penetrability. The membrane is designed with specific thickness, elasticity, and material properties that allow easy needle penetration while maintaining strong sealing capability to prevent fluid leakage.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The self-sealing pad exhibits different local properties: the membrane is designed to be highly sealing in areas away from the needle path, while the needle penetration zone is engineered to be more compliant and easier to penetrate. This local differentiation allows both easy needle insertion and effective fluid containment.

Inventive Principle:

Principle #3Local quality

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 solution significantly reduces the risk of clinician exposure to hazardous fluids by effectively isolating and containing any leakage, enhancing safety during medical procedures.

Implementation Method 1

The pad prevents any fluids that may have leaked from the distal opening of the needle from passing through the pad and escaping the needle assembly

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS10806900B2Insertion device with interface pad and methods of making

Publication Date: 2020.10.20 CR BARD INC

AI summary

An insertion assembly and method of manufacturing an insertion assembly. The method includes forming a catheter assembly including a catheter hub and a catheter, inserting a needle into the catheter assembly such that a distal tip of the needle extends distal of a distal end of the catheter, and permanently adhering an interface pad to the catheter hub. The interface pad can include a foam material including a haemostatic agent. The haemostatic agent can include microdispersed oxidized cellulose. The foam material can further include an antimicrobial agent such as chlorhexidine gluconate.