Click-lock removal sheath with movable seam
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Solution Overview
Problem
Existing sheaths for intravascular medical devices can disrupt blood flow and are challenging to remove without causing ischemia or compromising sterility, especially when used for extended periods.
Innovation Solution
A hub and sheath assembly with a movable seam and sealing members that can be configured to minimize disruption to blood flow, allowing for the gradual dilation of vessels and facilitating the removal of medical devices with minimal impact on blood flow, while maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sheath is inserted into a blood vessel to deliver medical devices, then medical devices can be introduced and removed, but blood flow is disrupted and ischemia risk increases
Solution Approach 1:
The sheath transitions from a closed tubular configuration during delivery to an open splittable configuration during removal, dynamically changing its structure to minimize blood flow disruption. The seam allows the sheath to split open, creating channels that facilitate blood flow while maintaining sheath functionality.
Solution Approach 2:
The sheath is divided into segments by the seam that can separate, creating multiple independent channels. This segmentation allows blood to flow through the spaces created by the separated sheath walls, reducing the harmful effect of blood flow disruption while maintaining the ability to deliver and remove medical devices.
2Duration of action of moving object
If a sheath remains in place for extended periods, then medical devices can be used continuously, but blood flow disruption causes ischemia
Solution Approach 1:
The sheath can be opened during removal to minimize prolonged blood flow disruption. The dynamic transition from closed to open configuration reduces ischemia risk during the extended period when the sheath remains in place, while still allowing continuous medical device usage.
3Duration of action of stationary object
If a sheath is used for extended periods, then continuous medical device support is provided, but removal becomes challenging without compromising sterility
Solution Approach 1:
The seam divides the sheath into separable segments that can be pulled apart during removal. This segmentation enables the sheath to be opened and removed in a controlled manner, maintaining sterility while facilitating ease of removal after extended use.
Solution Approach 2:
The sheath transitions from a closed sealed configuration to an open separable configuration during removal. This dynamic change enables sterile removal after extended retention by allowing the sheath to split open and be withdrawn without compromising the sterile field.
4Object-affected harmful factors
If a sheath is designed to minimize blood flow disruption, then ischemia risk is reduced, but the sheath structure becomes more complex
Solution Approach 1:
The seam creates segments that can separate to minimize blood flow disruption. This segmentation approach reduces ischemia risk by allowing blood flow through the spaces created by separated sheath walls, while adding relatively simple structural elements compared to more complex flow-management systems.
Data Source
AI summary
A hub and sheath assembly configured to be releasably disposed over a medical device. The hub and sheath assembly may comprise a valve hub including a first body portion, a second body portion, and a lumen extending therethrough and an elongate shaft including a lumen and a seam. The lumen and the seam may extend from a proximal end to a distal end of the elongate shaft. The elongate shaft may be releasably coupled to the valve hub. The seam may be movable from an interlocked configuration configured to hold the elongate shaft in a generally tubular configuration and an open configuration defining an opening extending along a length of elongate shaft.