Ocular Injection Packaging System for Sterile Handling

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Solution Overview

Problem

Current ocular injection devices face challenges in delivering substances to the posterior region of the eye due to safety risks associated with needle depth and placement, require higher force than users are comfortable with, and are prone to contamination and cumbersome handling within a sterile field.

Innovation Solution

A packaging system and kit that includes a tray assembly with a first and second tray member and a cover member, designed to maintain sterility and facilitate easy handling and preparation of medicament delivery devices within a sterile environment, allowing for interchangeable needle lengths and reducing contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional needles and syringes are used for direct injection into the eye, then injection can be performed, but safety risks increase due to difficulty in controlling needle depth and placement

Engineering Contradiction:
ImprovesafetyVSAvoidneedle depth and placement control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The injection system is divided into separate components: a syringe body and interchangeable needle assemblies with different lengths. This segmentation allows the practitioner to select the appropriate needle length for the specific procedure, improving safety by enabling precise control over injection depth while maintaining ease of operation through modular design

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system incorporates adjustable and interchangeable needle assemblies that can be dynamically selected based on the required injection depth. This dynamic adaptability allows the practitioner to optimize needle length for each specific case, resolving the contradiction between safety (through controlled depth) and ease of operation (through flexible selection)

Inventive Principle:
Principle #15Dynamics

2Productivity

If higher force is applied to expel the medicament, then delivery can be achieved, but user comfort decreases as users do not like to apply more than 2 N force

Engineering Contradiction:
Improvemedicament deliveryVSAvoiduser comfort
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The system replaces manual force application with a mechanical advantage mechanism in the syringe design. The plunger and barrel are configured to provide mechanical leverage, allowing the medicament to be expelled with forces below the 2 N comfort threshold while still achieving effective delivery. This substitution resolves the contradiction by maintaining productivity through mechanical assistance rather than relying on user strength

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If non-sterile portions are included in the kit for packaging and instructions, then completeness is improved, but contamination risk increases when components are unpackaged

Engineering Contradiction:
Improvekit completenessVSAvoidcontamination risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The kit design extracts and separates sterile components from non-sterile portions. The syringe and needle assemblies are packaged in sterile containers that can be opened without exposing the sterile components to contamination from non-sterile elements like packaging materials or instructions. This separation maintains kit completeness while eliminating contamination risk by preventing contact between sterile and non-sterile elements

Inventive Principle:
Principle #2Taking out (Extraction)

4Productivity

If known kits are used for ocular injection, then basic functionality is provided, but handling and manipulation become cumbersome within a sterile field

Engineering Contradiction:
Improveinjection functionalityVSAvoidhandling within sterile field
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The kit is designed with universal features that facilitate multiple functions within the sterile field. The syringe and needle assemblies are configured for easy grasping, positioning, and manipulation, with features like ergonomic handles and clear orientation markers. The system maintains basic injection functionality while improving ease of operation through design elements that simplify handling during the constrained conditions of sterile field work

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3413851B1packaging
Publication Date: 2023.09.27 CLEARSIDE BIOMEDICAL INC
  • EP3413851B1 patent drawingFigure 1
  • EP3413851B1 patent drawingFigure 2~4
  • EP3413851B1 patent drawingFigure 5~6

AI summary

An apparatus includes a first tray member, a second tray member, and a lid. The first tray member has a first portion and a second portion. The first portion defines a first volume, and the second portion defines a second volume configured to receive a medicament container. The second tray member defines a third volume having a sidewall including a retention portion configured to retain an ocular injector within the third volume. The second tray member is coupled within first volume such that the sidewall of the second tray member and a sidewall of the first tray member enclose the ocular injector. The lid is coupled to the first tray member about the first volume, and is constructed from a material formulated to maintain sterility of the first volume.