Expandable Introducer Sheath for Minimizing Vessel Trauma
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Solution Overview
Problem
Percutaneous medical procedures face challenges with large medical devices causing undesirable forces on vessel walls, leading to potential injury during insertion, especially in calcified or diseased vessels, necessitating a reduced insertion profile and protective barrier for the introducer system.
Innovation Solution
An implant delivery system featuring a catheter shaft with an expandable introducer sheath having a ribbed support member that shifts from a reduced profile to an expanded configuration, providing a protective barrier and allowing for minimization of insertion forces, and an anti-splash back valve to prevent blood loss.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Weight of moving object
If a large medical device is used for percutaneous procedures, then the device can perform its function, but it causes undesirable forces on vessel walls leading to potential injury
Solution Approach 1:
The introducer system is divided into multiple components: an introducer needle, an introducer sheath, and a delivery system. The introducer sheath itself is segmented into an inner liner and an expandable support member with ribs. This segmentation allows the system to be inserted through a small puncture site while the expandable portion provides protection without requiring a large insertion profile.
Solution Approach 2:
The delivery system is nested within the introducer sheath during insertion. The catheter shaft with the implant is inserted through the lumen of the introducer sheath, which is itself inserted through the puncture site in the vessel wall. This nesting allows the large delivery system to pass through a small access point.
Solution Approach 3:
The introducer sheath transitions from a compressed delivery configuration to an expanded deployed configuration. The expandable support member with ribs can expand radially outward to provide protection and support after insertion, changing the profile of the device from small during insertion to larger during use.
2Object-affected harmful factors
If an introducer sheath is used to protect the vessel wall, then vessel trauma is reduced, but the insertion profile must be large enough to accommodate the protective barrier
Solution Approach 1:
The introducer sheath is designed with dynamic expandability, transitioning from a compressed state during insertion to an expanded state after deployment. The expandable support member with ribs allows the sheath to provide full protective functionality when deployed, while maintaining a reduced insertion profile that can pass through small puncture sites in the vessel wall.
Solution Approach 2:
The physical parameters of the introducer sheath change between delivery and deployed states. The radial dimension expands from a compressed configuration that can pass through small access points to an expanded configuration that provides adequate protection and support within the vessel.
3Object-affected harmful factors
If the introducer sheath is expanded to provide protection, then the protective barrier is enhanced, but the device complexity increases
Solution Approach 1:
The expandable support member is segmented into multiple ribs that can flex and move relative to each other. This segmentation allows the structure to expand and provide protection while maintaining a relatively simple overall design. The ribs can be attached to the inner liner at discrete points, simplifying the attachment mechanism while achieving the protective function.
Solution Approach 2:
The inner liner is designed as a flexible thin-walled tube that can deform during expansion and contraction of the support member. This flexible film approach simplifies the overall structure compared to rigid alternatives, allowing the introducer sheath to adapt its shape while maintaining protection.
Data Source
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AI summary
An example implant delivery system is disclosed. The example implant delivery system includes a catheter shaft having a distal end region and proximal end region, an implant coupled to the distal end region of the catheter shaft, a handle coupled to the proximal end region of the catheter shaft and an introducer sheath (24) disposed along the catheter shaft. The introducer sheath (24) includes an inner liner including a lumen (34) and an expandable support member. The support member includes a plurality of ribs (40) extending along a length of the support member. The introducer sheath further includes a sheath attached to at least a portion of the support member, wherein the support member is designed to shift from a first position to an expanded position.