Transcutaneous Infusion Device with Nested Needle and Clutch Drive
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Solution Overview
Problem
Existing ambulatory infusion pumps for delivering therapeutic fluids, such as insulin to patients with diabetes, face challenges in reducing device size, improving user comfort, and enhancing fluid driving mechanisms for efficient and comfortable fluid delivery.
Innovation Solution
The development of a fluid delivery device with a transcutaneous access tool insertion mechanism that allows for single, uninterrupted motion of a needle/trocar and a clutch mechanism for efficient fluid drive, along with integrated monitoring capabilities through a test strip, to facilitate subcutaneous delivery and reduce pain and complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the device size is reduced to improve portability and comfort, then the device becomes more portable and comfortable, but the fluid driving mechanism becomes more difficult to implement effectively
Solution Approach 1:
The needle/trocar is nested within the cannula, and the insertion mechanism components are nested within the pump housing. This allows the fluid driving mechanism to be compact while maintaining functionality, resolving the contradiction between small device size and effective fluid driving capability
Solution Approach 2:
The insertion mechanism uses dynamic motion where the needle/trocar moves from retracted to extended position during insertion, and the fluid drive mechanism uses dynamic plunger movement to deliver fluid. This dynamic approach allows effective fluid driving in a compact device
2Device complexity
If the insertion mechanism is simplified to reduce device complexity, then the device becomes easier to manufacture and use, but the ability to reduce insertion pain is compromised
Solution Approach 1:
The needle/trocar is pre-loaded in a retracted position within the cannula before insertion. This preliminary positioning allows the sharp needle to penetrate skin first, then retract into the softer cannula, reducing pain without requiring complex mechanisms
Solution Approach 2:
The insertion tool is segmented into separate functional components: a sharp needle/trocar for skin penetration and a softer cannula for fluid delivery. This segmentation allows each component to be optimized for its specific function while keeping the overall mechanism simple
3Object-affected harmful factors
If the needle/trocar is retracted after insertion to reduce pain, then patient comfort is improved, but the fluid path priming becomes more difficult
Solution Approach 1:
The fluid delivery system maintains continuous pressure through the plunger mechanism, ensuring the fluid path remains primed and filled during the needle retraction process. This continuous action prevents air entry and maintains reliable fluid delivery
Solution Approach 2:
The fluid path is pre-primed through the needle/trocar before retraction, and the plunger is pre-positioned to maintain pressure. This preliminary priming ensures the fluid path remains filled during the needle retraction movement
Data Source
AI summary
A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.