Vascular Filter Assembly Low Profile Sheath Design
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Solution Overview
Problem
Current vascular filters for capturing embolic material in blood flow often require large sheaths for insertion, which can cause trauma and discomfort, and lack efficient mechanisms for fluid delivery and pressure relief during deployment and use.
Innovation Solution
A vascular filter assembly featuring a self-expanding filter member constrained by a low profile sheath with a port passing through the sidewall, allowing for dual use as a central venous access catheter for fluid administration and emboli capture, with a dual-diameter sheath design to reduce trauma and enhance comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large sheath is used for filter insertion, then the filter can be deployed effectively, but patient trauma and discomfort increase
Solution Approach 1:
The filter assembly is nested within a delivery catheter that is constrained by a sheath. The filter, catheter, and sheath are arranged concentrically, allowing the entire assembly to be delivered through a smaller introducer sheath while maintaining the ability to deploy the filter effectively at the target site.
Solution Approach 2:
The device is divided into distinct functional segments: the filter member, the delivery catheter, and the constraining sheath. This segmentation allows each component to be optimized independently - the sheath can be made low-profile for easy insertion while the filter maintains its deployment capabilities.
2Object-affected harmful factors
If a low profile sheath is used for filter insertion, then patient trauma is reduced, but fluid delivery efficiency decreases
Solution Approach 1:
The sheath incorporates apertures at specific locations to provide localized fluid delivery pathways. These apertures ensure efficient fluid delivery to the filter and surrounding tissue despite the overall low-profile design of the sheath, maintaining therapeutic effectiveness while minimizing patient trauma.
3Device complexity
If a sheath without apertures is used, then the filter structure is simpler, but pressure relief during deployment is insufficient
Solution Approach 1:
The sheath incorporates apertures that function as porous pathways for fluid and pressure relief. These openings allow built-up pressure during filter deployment to be relieved efficiently while maintaining the overall structural integrity and simplicity of the sheath design.
4Ease of manufacture
If a single-diameter sheath is used, then manufacturing is simpler, but fluid delivery and pressure relief are less efficient
Solution Approach 1:
The sheath features varying diameters at different sections, with larger diameters at locations requiring enhanced fluid delivery or pressure relief (such as near the filter deployment zone) and smaller diameters in other regions. This localized variation optimizes fluid dynamics while remaining compatible with standard manufacturing processes.
Data Source
AI summary
A vascular filter assembly includes a catheter body having a self-expanding filter member coupled thereto. A sheath is disposed directly over the self-expanding filter member such that the self-expanding filter member is at least partially constrained from expansion in a first configuration within an interior space defined between the sheath and the catheter body. The sheath includes at least one aperture disposed through a wall thereof.