Rotating Introducer Sheath Side Holes for Targeted Fluid Delivery
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Solution Overview
Problem
Existing introducer sheaths lack the ability to selectively target fluid delivery to specific locations within the vasculature, leading to inefficiencies in fluid use, increased patient discomfort, and prolonged procedure times due to vessel spasms and the need for higher volumes of vasodilating agents.
Innovation Solution
An introducer assembly with an inner and outer elongated body that allows for selective alignment of side holes through relative rotational orientation, enabling targeted fluid delivery by blocking or allowing fluid flow through specific subsets of side holes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If fluid is delivered through all side holes simultaneously, then fluid delivery coverage is maximized, but the amount of fluid needed increases and patient discomfort increases
Solution Approach 1:
The side holes are segmented into multiple groups along the longitudinal axis, with each group可控 to deliver fluid to specific vascular segments. The inner elongated body can selectively align with different outer elongated body to enable fluid delivery through specific subsets of side holes, allowing targeted rather than omnidirectional fluid delivery.
Solution Approach 2:
Different portions of the introducer assembly are designed with different functional characteristics - the inner elongated body provides selective blocking capability while the outer elongated body provides multiple side hole options. This allows local control of fluid delivery at specific longitudinal positions and circumferential orientations.
2Reliability
If higher volumes of vasodilating agents are used to reduce vessel spasms, then vessel relaxation is improved, but procedure time increases and patient discomfort increases
Solution Approach 1:
The introducer assembly enables preliminary targeted delivery of vasodilating agents to specific vascular locations before proceeding with the main procedure. By pre-treating specific vessel segments through selective side hole alignment, the system prevents vasospasms proactively rather than requiring higher volumes of medication during the procedure.
Solution Approach 2:
The system creates multiple copies of fluid delivery pathways through the array of side holes, allowing the same vasodilating agent to be delivered simultaneously to multiple vascular locations by rotating the inner elongated body to align different subsets of side holes.
3Device complexity
If non-selective fluid delivery is used, then device complexity is reduced, but fluid delivery precision to specific vasculature locations deteriorates
Solution Approach 1:
The system transitions from a static fluid delivery configuration to a dynamic one where the inner elongated body can rotate relative to the outer elongated body. This dynamic adjustment allows the clinician to select different rotational orientations to align specific inner body side holes with different outer body side holes, enabling precise targeting of fluid delivery to specific vascular locations.
Solution Approach 2:
The inner elongated body is nested within the outer elongated body, with both components defining their own sets of side holes. This nested configuration allows the inner component to selectively block or enable fluid flow through specific subsets of the outer component's side holes based on rotational orientation, achieving precise fluid delivery control.
Data Source
AI summary
An introducer assembly includes a plurality of selectable side holes through which a fluid can be delivered. In some examples, an introducer assembly includes an outer elongated body defining a plurality of outer body side holes and an inner elongated body defining a plurality of inner body side holes. The inner elongated body is configured to rotate relative to the outer elongated body between a first rotational orientation in which a first subset of outer body side holes aligns with a first subset of inner body side holes and the inner elongated body blocks fluid flow out of the outer elongated body through a second subset of outer body side holes, and a second rotational orientation in which the second subset of outer body side holes aligns with a second subset of inner body side holes and inner elongated body blocks fluid the first subset of outer body side holes.