Infusion Set Inserter Assembly With Skin-Lifted Cannula Coupling
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Solution Overview
Problem
Existing wearable drug delivery devices for parenteral administration face challenges such as malfunction, size, weight, and cost, as well as frequent relocation issues, and there is a need for improved inserter assemblies for infusion sets that can efficiently and reliably deliver therapeutic compounds.
Innovation Solution
The inserter assembly includes a casing with a sharp holder, a bias member, and a trigger mechanism that propels an insertion sharp out of the casing upon actuation, featuring a cannula sub-assembly that integrates with an infusion set base, utilizing adhesive attachment and spring mechanisms for controlled deployment and retraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If wearable devices are designed for controlled release of therapeutics, then drug delivery reliability 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 with reservoir. This segmentation allows the heavy drug delivery mechanism to be used repeatedly while only the lighter infusion set is replaced, reducing overall weight for the user while maintaining reliability of the delivery system.
Solution Approach 2:
The reservoir containing the therapeutic compound is extracted as a separate disposable component (infusion set) from the main inserter device. This allows the bulk of the device weight to be in the reusable portion, while the disposable portion remains lightweight, solving the contradiction between reliable delivery and user comfort.
2Volume of moving object
If device size is reduced for wearability, then ease of wear is improved, but manufacturing complexity increases
Solution Approach 1:
The infusion set base is nested within the inserter assembly during the insertion process. The inserter provides the complex mechanical functions while the infusion set is compactly stored within it, achieving a small external footprint despite the complexity of the integrated system.
Solution Approach 2:
The infusion set is pre-assembled and sterilized separately, then integrated into the inserter assembly at the point of use. This preliminary preparation simplifies the manufacturing of each component individually while achieving a compact integrated device, reducing overall manufacturing complexity.
3Ease of operation
If adhesive attachment is used for skin application, then ease of application is improved, but skin displacement requirements increase
Solution Approach 1:
The adhesive on the infusion set base is activated in advance by removing the protective covering before insertion. This preliminary adhesive application ensures immediate skin attachment upon insertion, reducing the distance the skin must be displaced during the procedure while maintaining ease of application.
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 effort and improving the reliability of drug delivery, while minimizing device size and cost.
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.