Split Sheath Catheter for Precise Prosthetic Valve Deployment
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Solution Overview
Problem
Current minimally invasive aortic valve replacement technologies face challenges in accurately deploying prosthetic valves due to potential shifting during deployment, leading to suboptimal placement and increased complexity in procedures, especially when relying on videographic feedback without direct visualization.
Innovation Solution
A split sheath catheter system with axially moveable distal and proximal portions, where the distal sheath has a radially inwardly biased section to minimize vascular trauma and ensure precise deployment, allowing for controlled exposure and retraction of the medical device, thereby maintaining accurate positioning and reducing the risk of paravalvular leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a single sheath is used to deliver and deploy the medical device, then the device can be delivered to the target site, but the device may shift position during deployment leading to inaccurate placement
Solution Approach 1:
The sheath is divided into two separate portions: a distal sheath portion and a proximal sheath portion. This segmentation allows independent control of each portion during deployment, enabling the distal portion to remain stationary while the proximal portion is retracted, thereby preventing device shifting and ensuring accurate placement at the target site.
2Ease of operation
If the sheath is fully withdrawn to expose the medical device, then the device can be deployed, but vascular trauma may occur during retrieval
Solution Approach 1:
By segmenting the sheath into distal and proximal portions, the system allows selective retraction of the proximal portion while leaving the distal portion in place. This enables device exposure and deployment without fully withdrawing the sheath, thereby minimizing vascular trauma during the retrieval process.
Solution Approach 2:
The distal sheath portion is positioned in advance to cover the medical device, and the proximal sheath portion is retracted to expose the device for deployment. This preliminary arrangement allows the device to be exposed and deployed while the distal portion remains in place to prevent vascular trauma during retrieval.
3Ease of operation
If videographic feedback is used for positioning, then the procedure can be performed minimally invasively, but the complexity of the procedure increases due to lack of direct visualization
Solution Approach 1:
The segmented sheath structure provides mechanical control for precise device positioning, compensating for the limitations of videographic feedback. By independently controlling the distal and proximal sheath portions, the operator can achieve accurate placement without direct visualization, thereby managing the procedural complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The split sheath catheter system enables more consistent and precise placement of prosthetic valves, reducing the need for dynamic catheter positioning and minimizing vascular trauma, thereby simplifying the procedure and enhancing the accuracy of valve deployment.
Implementation Method 1
the distal sheath has a proximal section that is configured to bias radially inwardly to minimize a larger exposed annular surface
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3C
AI summary
A sheathed catheter system is described where the sheath comprises a distal portion and a proximal portion that are moveable axially relative to each other, and relative to a tube carrying a medical device thereon. The distal and proximal sheath portions can be brought together in order to enclose therewithin the medical device. The distal sheath has a proximal section that is configured to bias radially inwardly to minimize an otherwise exposed annular surface catching on protruding surfaces that may exist on the catheter or other medical tool in use at the time, or to minimize scraping the inner native lumen of the patient upon retrieval.