Spring-Biased Infusion Set Inserter for Secure Skin Attachment
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Solution Overview
Problem
Existing wearable drug delivery devices for parenteral administration face challenges such as malfunction, size, weight, and cost, along with frequent relocation issues, and require improvements for effective and reliable use.
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, combined with an infusion set base and adhesive for secure attachment to the skin, allowing for controlled and efficient delivery of therapeutic compounds.
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, weight, and cost increase
Solution Approach 1:
The patent extracts the reservoir (cartridge or syringe) from the wearable device, allowing the device to be lighter and more comfortable while still achieving automatic drug delivery. The reservoir can be separately handled and replaced, reducing the weight burden on the user.
Solution Approach 2:
The wearable device is designed to work with different types of reservoirs (cartridges or syringes), providing multi-functionality. This universal design allows the same device platform to serve multiple purposes with different drug reservoirs, reducing overall system cost and weight.
2Extent of automation
If a wearable device is designed for controlled release of therapeutics, then automatic drug delivery is achieved, but device complexity and cost increase
Solution Approach 1:
The system is segmented into distinct components: a reusable wearable device and disposable reservoirs. This segmentation simplifies the wearable device by removing the need for complex reservoir management mechanisms, while maintaining automatic drug delivery capability.
Solution Approach 2:
The patent employs disposable reservoirs (cartridges or syringes) that are discarded after use. This eliminates the need for complex cleaning, sterilization, and maintenance mechanisms in the wearable device, reducing its complexity and cost.
3Reliability
If adhesive is applied to attach the infusion set base to the skin, then secure attachment is achieved, but frequent relocation is required
Solution Approach 1:
The adhesive is applied in advance to the infusion set base before insertion, ensuring secure attachment is established before the device is used. This preliminary action prevents the need for frequent relocation during the infusion period.
Solution Approach 2:
The adhesive attachment mechanism is merged with the insertion process itself. The adhesive secures the base to the skin, and when combined with the insertion sharp penetrating the skin, creates a more permanent and secure attachment that reduces relocation frequency.
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 placing infusion sets, reducing the need for frequent relocation and enhancing the usability and reliability of wearable drug delivery systems.
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.
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.