Infusion Set Inserter Assembly for Reliable Skin-Adhered Placement
Find Innovative SolutionsGenerate Solutions
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 through the skin upon adhesive application, featuring a cannula subassembly and infusion set base with cooperating coupling features for secure attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Weight of moving object
If wearable devices are made smaller and lighter, then portability and comfort are improved, but manufacturing complexity and cost control become more challenging
Solution Approach 1:
The device is divided into modular components including a reusable inserter assembly and disposable infusion set cartridges. This segmentation allows independent optimization of each module's weight and complexity, enabling the overall device to be smaller and lighter while maintaining functionality through standardized interfaces between modules.
Solution Approach 2:
The infusion set base is nested within the inserter assembly housing, and the cannula subassembly is nested within the infusion set base. This nested configuration maximizes space utilization, reducing the overall device footprint and weight while maintaining all necessary functional components.
2Volume of moving object
If the device is made more compact, then size and weight are reduced, but reliability may be compromised due to tighter tolerances and component crowding
Solution Approach 1:
The infusion set base is pre-assembled with the cannula subassembly in a controlled manufacturing environment with proper tolerances and quality assurance. This preliminary assembly ensures reliable connections before the compact final assembly, preventing reliability issues that might arise from tight tolerances in the compacted device.
Solution Approach 2:
Coupling features such as the cannula receiving void and cooperating engagement structures act as intermediaries between components. These intermediary elements provide tolerance compensation and ensure reliable mechanical and fluid connections even in the compact device configuration, preventing direct contact between components that would require extremely tight tolerances.
3Stability of the object's composition
If adhesive strength is increased to prevent skin detachment, then skin adherence is improved, but skin trauma and discomfort increase during removal
Solution Approach 1:
The adhesive system is designed with dynamic characteristics that allow strong initial bonding for stability during wear, but enable controlled release during removal. The adhesive formulation and application area are optimized to distribute forces evenly during removal, reducing peak stresses that cause skin trauma while maintaining adequate adherence during the infusion period.
Solution Approach 2:
The adhesive properties are carefully selected to change characteristics over time - initially providing strong bonding strength for stability, then allowing gradual reduction of bond strength or increase of release characteristics toward the end of the wear period. This parameter change enables both strong adherence and gentle removal without skin trauma.
4Reliability
If the trigger mechanism is made more sensitive to detect skin tugging, then actuation reliability is improved, but false activation from normal skin movement increases
Solution Approach 1:
The trigger mechanism incorporates feedback from multiple sources including the adhesive bond status and skin movement patterns. The system monitors the force and duration of skin tugging, requiring a specific pattern or threshold to be exceeded before actuation occurs. This feedback mechanism distinguishes between intentional removal actions (strong, sustained tugging) and normal skin movements (weak, brief movements), preventing false activation while maintaining reliable actuation for intended use.
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
Facilitates reliable and efficient placement of infusion sets with reduced size and weight, minimizing malfunctions and skin adherence challenges, enabling automatic drug delivery over time.
Implementation Method 1
a bias member within the cavity. The bias member may be positioned between the sharp holder and a wall of the cavity. The inserter assembly may further comprise a trigger having a first state in which the bias member is maintained in an energy storing state and a second state in which the bias member is released from the energy storing state. 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.
Implementation Method 2
The inserter assembly may further comprise an infusion set base in retaining engagement with the body. The infusion set base may have an adhesive included on a bottom face thereof.
Data Source
AI summary
In accordance with yet another embodiment of the present disclosure an inserter assembly may comprise a housing. The inserter assembly may further comprise an infusion set having adhesive on a portion thereof for adhering the portion of the infusion set to skin. The inserter assembly may further comprise a sharp bearing body. The inserter assembly may further comprise a trigger. The inserter assembly may further comprise an insertion bias member held in an energy storing state by the trigger. The insertion bias member may urge the sharp bearing body from a raised state to a forward state when the trigger is released. The inserter assembly may further comprise a means for releasing the trigger after inserter assembly is withdrawn from the body and skin adhered to the portion of the infusion set has been lifted from underlying anatomy.