Pre-filled Syringe System with Depth-Controlled Needle Shield

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Solution Overview

Problem

Existing pre-filled syringes face challenges such as the need for precise needle insertion angle, depth control, and post-injection needle protection, with potential for incorrect injections and needle stick injuries.

Innovation Solution

A pre-filled syringe system with a housing and needle shield that allows for controlled needle insertion depth and automatic protection after use, eliminating the need for repositioning during injection and providing a simple, effective needle guard mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a pre-filled syringe is used for subcutaneous injection, then drug delivery efficiency is improved, but the user must maintain a precise forty-five-degree angle and skin fold, increasing operation difficulty

Engineering Contradiction:
Improvedrug delivery efficiencyVSAvoidinjection angle control
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The syringe is pre-assembled with the needle attached at the correct forty-five-degree angle to the barrel, eliminating the need for the user to manually position and maintain this precise angle during injection. The pre-configured state ensures proper orientation is achieved before use.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The syringe design incorporates a self-aligning mechanism where the needle and barrel are structurally integrated to automatically maintain the correct injection angle without requiring active user control or adjustment during the injection process.

Inventive Principle:
Principle #25Self-service

2Device complexity

If manual needle insertion is used, then device simplicity is maintained, but depth control is impossible, leading to potential needle penetration too deep

Engineering Contradiction:
Improveinsertion mechanism simplicityVSAvoidneedle insertion depth control
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

A flange is added to the needle at a specific location corresponding to the desired injection depth. This localized structural feature acts as a depth stop, ensuring the needle penetrates only to the appropriate depth while maintaining the overall simplicity of the manual insertion mechanism.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The needle depth control feature (flange or stop) is pre-configured on the needle before use, establishing the correct insertion depth in advance. This eliminates the need for complex real-time depth control mechanisms during the injection process.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If no needle protection is provided, then device simplicity is maintained, but needle stick injuries occur after injection

Engineering Contradiction:
Improveneedle protection mechanismVSAvoidneedle stick injury risk
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

A protective shield is integrated into the syringe structure, designed to slide over and enclose the needle after injection. The shield nests within the syringe body when not in use and automatically covers the needle when activated, providing protection without adding significant external complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The needle protection mechanism is designed to be automatically activated by the user's natural injection motion. After the injection is complete, the shield is engaged through a simple sliding or snapping action that self-covers the needle without requiring additional tools or complex操作步骤.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP4135796B1Pre-filled syringe system and method
Publication Date: 2025.12.31 BAYER HEALTHCARE LLC
  • EP4135796B1 patent drawingFigure 1
  • EP4135796B1 patent drawingFigure 2
  • EP4135796B1 patent drawingFigure 3

AI summary

This disclosure relates to pre-fill ed syringes and their methods for use and injection. The embodiments provide a pre-filled syringe system for controlled depth of injection in a subject, including a pre-fill ed syringe having a needle tip and a plunger for injecting the contents of the pre-filled syringe; a housing for holding the pre-filled syringe and needle tip in a defined position for a depth of injection; and a needle shield mounted on the housing for releasable movement from a locked injection position to a shield position, wherein after the needle shield is moved into the locked injection position with the needle tip extended out of the needle shield and pre-filled syringe system, the needle can be inserted into the subject at a defined depth of injection. The embodiments further provide methods of injecting a subject using a pre-filled syringe system, including providing a pre-filled syringe system having a housing, a needle shield mounted on the housing, and a pre-filled syringe with a needle tip; moving the needle shield mounted on the housing into a locked injection position to extend the needle tip of the pre-filled syringe and system at a defined length out of the needle shield and pre-filled syringe system; inserting the needle tip of the pre-filled syringe and system into a subject at a defined injection depth, and injecting the contents of the pre-filled syringe and system into the subject.