Infusion Set Inserter Assembly With Adhesive-Lift Cannula Coupling
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, coupled with an infusion set base and adhesive for secure attachment, allowing for automatic and controlled drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If a wearable device is designed for controlled release of therapeutics, then automatic drug delivery is achieved, but the 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 electronic control system and power source, while the infusion set contains the drug reservoir. This segmentation allows the heavy automated components to be used only during insertion, reducing the weight burden on the patient during prolonged wear.
Solution Approach 2:
The insertion sharp is pre-loaded into the inserter assembly in a ready-to-deploy state. The device is prepared in advance with the infusion set attached and the insertion mechanism loaded, allowing for quick application to the skin without requiring the patient to assemble components during the procedure.
2Extent of automation
If a wearable device is designed for controlled release of therapeutics, then automatic drug delivery is achieved, but the device cost increases
Solution Approach 1:
By segmenting the device into reusable and disposable portions, the expensive electronic control system is amortized over multiple uses, while the inexpensive disposable infusion set is manufactured using cost-effective methods such as molded plastics and standard medical-grade materials.
Solution Approach 2:
The infusion set is designed as a disposable component that is discarded after a single use or after the drug is depleted. This eliminates the need for complex sterilization and maintenance systems, reducing overall device cost while maintaining high reliability for the critical insertion function.
3Strength
If adhesive is applied to attach the device to skin, then secure attachment is achieved, but frequent relocation is required due to skin adherence issues
Solution Approach 1:
The attachment system is segmented into a reusable inserter assembly that remains on the skin long-term and a disposable infusion set that is periodically changed. The adhesive is applied to the base of the inserter assembly, which is designed to maintain skin attachment for extended periods while allowing for controlled replacement of the infusion set.
Solution Approach 2:
A adhesive barrier layer or transfer tape is used as an intermediary between the adhesive and the skin. This intermediary protects the skin from direct adhesive contact, reduces irritation, and allows for cleaner removal and replacement of the infusion set without compromising the long-term attachment of the inserter assembly.
4Productivity
If the insertion sharp is propelled through the skin, then drug delivery is achieved, but malfunction rate increases
Solution Approach 1:
The insertion sharp is pre-positioned and pre-loaded into the inserter assembly during manufacturing, ensuring proper alignment and reducing the risk of malfunction during patient application. The sharp is held in a controlled environment until use, minimizing exposure to contaminants and mechanical damage.
Solution Approach 2:
The device includes fail-safe mechanisms such as backup springs, latch systems, and mechanical stops that prevent malfunction even if one component fails. The insertion mechanism is designed with redundant elements that compensate for potential manufacturing variations or wear, maintaining high reliability over the device lifecycle.
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
The inserter assembly provides a reliable and efficient method for attaching and deploying infusion sets, reducing manual intervention and improving patient compliance by ensuring secure skin attachment and controlled drug delivery.
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
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.