Expandable Distal Tip Anchor for Non-Occluding Introducer Sheaths
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Solution Overview
Problem
Existing introducer sheaths with large diameters cause vessel occlusion and potential damage during medical procedures, leading to limb ischemia and reduced blood flow, necessitating a solution that maintains vessel patency and perfusion.
Innovation Solution
An introducer sheath with an expandable distal tip anchor that deploys to an expanded configuration, securing against the vessel wall and a proximal anchor that traps tissue, maintaining vessel access and sealing the entry site, while allowing blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If an introducer sheath with large diameter is used to deliver medical devices, then the device delivery capability is improved, but vessel occlusion and blood flow reduction occur
Solution Approach 1:
The introducer sheath is divided into distinct functional segments: a large-bore proximal portion for device delivery and a distal portion with an expandable anchor for vessel wall engagement. This segmentation allows the proximal segment to maintain large diameter for device passage while the distal segment manages vessel occlusion through anchoring, resolving the contradiction between device delivery capability and vessel patency maintenance.
2Volume of moving object
If an introducer sheath with large diameter is used, then large bore therapy devices can be delivered, but vessel damage and tearing risk increases
Solution Approach 1:
The expandable anchor is deployed at the distal end of the introducer sheath before device delivery to preemptively secure the sheath to the vessel wall. This preliminary anchoring action prevents the large-bore sheath from causing vessel damage or tearing during subsequent device passage, as the anchor distributes mechanical stresses and stabilizes the sheath position.
3Ease of operation
If an introducer sheath is used to maintain vessel access, then device delivery is enabled, but sealing the entry site becomes difficult
Solution Approach 1:
The introducer sheath integrates two functions into a single device: the expandable distal anchor provides both vessel wall engagement for stable access maintenance and sealing at the entry site. By merging the anchoring and sealing functions into one integrated component, the device achieves easy vessel access maintenance while simplifying entry site sealing, rather than requiring separate components.
Data Source
AI summary
An introducer sheath for use in delivering a device includes a hub, an elongate shaft including a proximal end region connected to the hub, a distal end region and a lumen extending therethrough. Further contemplated is a distal tip anchor that may be disposed proximate the distal end region. The distal tip anchor may have a collapsed configuration and an expanded configuration. The hub may include an actuation element operatively connected to the distal tip anchor such that actuation of the actuation element may deploy the distal tip anchor into the expanded configuration.