Infusion Set Inserter Assembly With Adhesive-Lifted Spring Release
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Solution Overview
Problem
Existing wearable drug delivery devices for parenteral administration face challenges such as malfunction, size, weight, and frequent relocation, and require improvements in design to enhance usability and reliability.
Innovation Solution
An inserter assembly with a casing, sharp holder, bias member, and trigger mechanism that allows for controlled and automatic insertion of an insertion sharp, facilitated by a bias member that transitions from an energy-storing state to propel the sharp out of the casing upon trigger actuation, integrated with an adhesive base for secure attachment to the skin.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a wearable device is designed for automatic drug delivery, then convenience and adherence to treatment schedules are improved, but device size and weight increase
Solution Approach 1:
The patent extracts the infusion pump functionality from a wearable device, using an external infusion pump connected via tubing to an implanted reservoir. This separates the heavy pumping mechanism from the patient's body, retaining only the lightweight reservoir and catheter system, thereby maintaining automatic drug delivery convenience while significantly reducing device weight.
Solution Approach 2:
The patent employs a nested structure where the catheter is inserted through the skin into a subcutaneous reservoir. The reservoir is positioned within the fatty tissue layer, nested between the skin surface and deeper muscle tissue. This nesting approach minimizes the external footprint and weight while providing adequate storage capacity.
2Weight of moving object
If the device is made smaller and lighter, then patient comfort is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The patent divides the drug delivery system into separate functional modules: an implanted reservoir system (catheter, reservoir, adhesive patch) and an external infusion pump. This segmentation allows each component to be manufactured independently using optimized processes, reducing overall manufacturing complexity while enabling a smaller, lighter implanted device.
Solution Approach 2:
The patent employs a disposable adhesive patch and reservoir assembly that can be pre-manufactured and sterilized, then applied by the patient or healthcare provider. This disposable approach simplifies manufacturing by eliminating the need for complex sterilization and assembly procedures for the implanted components, reducing both complexity and cost.
3Reliability
If the insertion mechanism uses a bias member for automatic sharp deployment, then reliability is improved, but device complexity increases
Solution Approach 1:
The patent uses a bias member (spring) that is pre-loaded in an energy-storing state during device assembly. The spring is constrained by a latch mechanism until insertion is required. When the adhesive patch is applied to the skin, the latch releases, allowing the pre-loaded spring to automatically propel the sharp through the skin into the reservoir. This preliminary action ensures reliable insertion without requiring complex active control systems.
Solution Approach 2:
The insertion mechanism is designed to be self-actuating through the use of the bias member and latch system. Once the adhesive patch is applied to the skin, the mechanical system automatically triggers the sharp deployment without requiring external power sources, motors, or complex electronic controls. The stored mechanical energy in the bias member provides the necessary force for reliable insertion.
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 user-friendly mechanism for automatic drug delivery, reducing device size and weight while minimizing malfunctions and frequency of relocation, enhancing patient convenience and adherence to treatment schedules.
Implementation Method 1
The infusion set base has an adhesive included on a bottom face thereof configured for attachment to the skin
Implementation Method 2
The bias member is positioned between the sharp holder and a wall of the cavity... The bias member is configured to propel the sharp holder relative to the body to displace the insertion sharp out of the casing when released from the energy storing state
Data Source
Figure 1A
Figure 1B
Figure 1C
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.