Infusion Set Inserter Assembly for Adhesion-Triggered Cannula Insertion
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Solution Overview
Problem
Existing wearable drug delivery devices for parenteral administration face challenges such as malfunction, size, weight, and cost, and often require frequent relocation due to skin adhesion issues.
Innovation Solution
An inserter assembly with a casing, sharp holder, bias member, and trigger mechanism that propels an insertion sharp out of the casing upon actuation, facilitated by adhesive attachment to the skin and skin tugging, allowing for controlled deployment of an infusion set.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If adhesive is applied to secure the infusion set to the skin, then the device remains in place longer, but skin irritation or damage may occur during removal
Solution Approach 1:
The patent applies a protective coating to the adhesive layer before it contacts the skin. This preliminary protective action prevents the adhesive from directly damaging the skin during removal while still maintaining effective adhesion during the wear period
Solution Approach 2:
The patent introduces a protective layer as an intermediary between the adhesive and the skin. This intermediate layer allows the adhesive to perform its function of securing the device while preventing direct contact between the adhesive and skin that could cause damage
2Volume of moving object
If the inserter assembly is made compact to reduce size, then portability improves, but the mechanism for propelling the insertion sharp becomes more complex
Solution Approach 1:
The patent employs a spring-loaded mechanism that automatically propels the insertion sharp when triggered. The system serves itself by using stored mechanical energy in the spring to perform the insertion action without requiring external power sources or complex control systems
Solution Approach 2:
The patent uses a disposable inserter assembly with a simple, inexpensive spring mechanism rather than a reusable system with complex propulsion components. This approach reduces overall device complexity while maintaining compact size
3Speed
If the insertion sharp is pre-loaded in the sharp holder, then insertion speed improves, but the risk of accidental activation increases
Solution Approach 1:
The patent uses a latch mechanism that prevents the spring from propelling the insertion sharp unless deliberately triggered. This preliminary protective action counteracts the potential for accidental activation while maintaining the readiness of the pre-loaded sharp for rapid insertion when needed
4Weight of moving object
If the infusion set base is made lightweight to reduce overall device weight, then comfort during wear improves, but structural strength may be compromised
Solution Approach 1:
The patent employs composite materials or optimized material compositions for the infusion set base that provide high strength-to-weight ratio. This allows the base to remain lightweight for comfort while maintaining sufficient structural strength to support the adhesive and secure the infusion set
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
Enables reliable, compact, and cost-effective automatic drug delivery by ensuring proper insertion and adhesion to the skin, reducing the need for frequent relocation.
Implementation Method 1
The infusion set base may have an adhesive included on a bottom face thereof
Implementation Method 2
The bias member may be positioned between the sharp holder and a wall of the cavity... The bias member may be configured to propel the sharp holder to displace the insertion sharp out of the casing when released from the energy storing state
Data Source
AI summary
An inserter assembly comprising a first unit including a skin contacting face which surrounds an opening and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprising a spring biased insertion assembly. The second unit further comprising a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.