Procedural Sheath Adapter for Vascular Closure
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Solution Overview
Problem
Current vascular closure devices require time-consuming sheath exchanges during vascular procedures, leading to complications for patients and operators, as they need to transition from procedural sheaths to closure sheaths, which can cause bleeding issues at puncture sites.
Innovation Solution
A sheath adapter that connects vascular closure devices to procedural sheaths, eliminating the need for sheath exchanges by providing a universal interface for different sheath configurations, allowing for snap-fit, interference fit, or latch-based connections, enabling direct integration of closure devices with procedural sheaths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a closure insertion sheath is used with vascular closure devices, then the closure device can be properly sealed and deployed, but the procedure becomes time-consuming and requires sheath exchange
Solution Approach 1:
The adapter provides a universal interface that allows the same procedural sheath to be used for both the intervention and closure phases. The adapter includes a proximal portion that interfaces with the procedural sheath and a distal portion that interfaces with the closure device, enabling one sheath to serve multiple functions without requiring exchange to a specialized closure sheath.
Solution Approach 2:
The adapter acts as an intermediary component between the procedural sheath and the closure device. It mediates the connection by providing compatible interfaces on both sides, allowing the closure device to be deployed through the existing procedural sheath without direct integration, thus eliminating the need for sheath exchange while maintaining proper sealing.
2Adaptability or versatility
If a specialized closure insertion sheath is used, then the closure device interface is optimized, but the procedural sheath must be exchanged causing complications
Solution Approach 1:
The adapter enables the procedural sheath to maintain its original function while also providing compatibility with the closure device. By adding the adapter component, the system achieves multi-functionality without requiring replacement of the original procedural sheath, thus avoiding the complications associated with sheath exchange.
Solution Approach 2:
The solution segments the closure system into separate components: the existing procedural sheath, the adapter, and the closure device. This segmentation allows each component to maintain its optimized design while the adapter provides the necessary interface compatibility, eliminating the need to exchange sheaths while preserving interface adaptability.
3Reliability
If sheath exchange is performed, then closure device deployment is enabled, but bleeding risks and complications increase
Solution Approach 1:
The adapter serves as a mediator that enables closure device deployment through the existing procedural sheath without requiring sheath exchange. By maintaining continuous access through the same sheath, the adapter eliminates the need to remove and reinsert another sheath, thereby reducing the risk of bleeding and complications associated with repeated puncture site manipulation.
Solution Approach 2:
The adapter enables continuous use of the same sheath throughout the entire procedure from intervention to closure. This continuity maintains the sealed access pathway without interruption, preventing bleeding risks that would otherwise occur during sheath exchange when the puncture site is exposed and manipulated.
Data Source
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AI summary
A sheath adapter configured for use between a tissue puncture closure device and a procedural sheath, the procedural sheath adapted for insertion into a tissue puncture, and the tissue puncture closure device adapted for partial insertion into the procedural sheath and sealing of the tissue puncture, the sheath adapter comprising: a sheath connection portion positioned at a distal end of the sheath adapter; a closure device connection portion positioned at a proximal end of the sheath adapter; an aperture sized for passage of a carrier tube of the tissue puncture closure device through the sheath adapter.