Infusion Set Inserter Assembly Using Adhesive-Triggered Cannula Retraction
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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 require frequent relocation due to skin adherence 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 adhesion to skin and skin displacement, allowing for controlled insertion and retraction of a cannula sub-assembly into an infusion set base.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If wearable devices are designed for controlled release of therapeutics, then drug delivery function is improved, but device size and weight increase
Solution Approach 1:
The device is divided into separate components: a reusable inserter assembly and a disposable infusion set. The inserter assembly contains the drive mechanism and control electronics, while the infusion set contains the reservoir and delivery components. This segmentation allows the heavy components to be reused while only the lighter disposable components are replaced frequently.
Solution Approach 2:
The infusion set is nested within the inserter assembly during insertion. The cannula is inserted through the skin first, then the reservoir and other components are sequentially attached and positioned, creating a compact nested structure that reduces overall device footprint and weight.
2Weight of moving object
If devices are made smaller and lighter, then portability is improved, but manufacturing complexity increases
Solution Approach 1:
The infusion set is designed as a disposable component that is manufactured with simpler, more cost-effective methods using standard medical-grade materials and assembly techniques. By offloading the complex reusable components to a separate inserter assembly, the disposable portion can be manufactured more simply and at lower cost.
3Stability of the object's composition
If adhesive is applied to skin for device attachment, then device stability is improved, but skin displacement requirements increase
Solution Approach 1:
The adhesive is applied to the skin surface in advance and allowed to set before device attachment. This preliminary bonding creates a stable anchor point that reduces the displacement distance required during subsequent device application and removal operations.
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 efficient, controlled, and reliable insertion and retraction of infusion sets with reduced device size and cost, improving patient convenience and device reliability.
Implementation Method 1
an adhesive included on a bottom face thereof... once the adhesive is stuck to skin
Implementation Method 2
a bias member within the cavity... positioned between the sharp holder and a wall of the cavity... configured to propel the sharp holder to displace the insertion sharp out of the casing when released from the energy storing state... The energy storing state of the first bias member is a compressed 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.