Needle Spacer for Subcutaneous Injection Depth Control
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Solution Overview
Problem
Subcutaneous injections with needles of 13 mm or greater length pose challenges in reliably achieving and maintaining the desired depth and angle of 4 mm to 8 mm and 90-degrees relative to the skin, while also ensuring visibility and stability during administration.
Innovation Solution
A needle spacer system comprising a first portion engaging the needle hub and a second portion with a skin-contacting surface, designed to maintain a predetermined distance and angle, support the needle radially, axially, and laterally, and allow visualization of the injection site, featuring transparent materials, windows, and adhesive surfaces for stability and ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a needle of 13 mm or greater length is used, then the needle can reach the required injection depth, but it becomes difficult to reliably achieve and maintain the desired depth of 4 mm to 8 mm and angle of 90-degrees relative to the skin
Solution Approach 1:
A needle spacer is introduced as an intermediary component between the needle hub and the skin surface. The spacer includes a depth-stop feature that physically limits needle insertion depth to 4-8 mm, and a flange with wing tabs that provide visual alignment markers to ensure 90-degree angle relative to the skin, thereby enabling precise depth and angle control when using longer needles
2Manufacturing precision
If a needle spacer is introduced to control depth and angle, then injection precision is improved, but the device complexity increases
Solution Approach 1:
The needle spacer combines multiple functions into a single integrated component: the depth-stop feature controls insertion depth, the flange with wing tabs provides angular alignment, and the transparent material allows visualization of the injection site. This merging of functions reduces the need for multiple separate devices while achieving precise depth and angle control
3Loss of information
If the needle spacer uses transparent materials and windows, then visualization of the injection site is improved, but the manufacturing complexity increases
Solution Approach 1:
The needle spacer is manufactured from transparent or translucent plastic material specifically at the portions that require visualization (the spacer body and flange), while maintaining structural features like the depth-stop and wing tabs. This localized transparency allows clinicians to visually monitor the injection site through the spacer without requiring complex transparent assemblies, simplifying manufacturing while achieving the visualization goal
Data Source
AI summary
Needle spacers for use in administering subcutaneous injections, as well as subcutaneous injection systems including such needle spacers, are disclosed. In certain embodiments, the needle spacer comprises a first portion configured to engage a hub of a needle that comprises such a hub; and a second portion coupled to the first portion and extending distally therefrom, the second portion including a skin-contacting surface disposed on a distal end thereof, wherein the skin-contacting surface is configured to engage a surface of skin of a subject. The second portion is configured to maintain a predetermined distance between the hub of the needle and the surface of the skin, and to permit insertion of the needle to a depth of about 4 mm to about 8 mm below the surface of the skin during administration of a subcutaneous injection via the needle.