Stent Delivery System Partial Sheathing and Valve Protection
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Solution Overview
Problem
Current stent delivery systems require stents to be fully crimped and sheathed before storage and transport, which can damage the stent's structural integrity and render it unusable for subsequent deployment, especially for valved stents with deformable polymer valves that can undergo plastic deformation during prolonged compression.
Innovation Solution
A stent delivery system that allows for partial sheathing and storage with the valve in an expanded state, enabling crimping and sheathing just before deployment, using a mechanism with multiple triggers and a flexible pusher/anchor to prevent accidental deployment and maintain the valve's operational configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the stent is fully crimped and sheathed before storage and transport, then the stent can be protected during storage and transport, but the stent's structural integrity is damaged and it becomes unusable for subsequent deployment
Solution Approach 1:
The delivery system is divided into multiple segments including an outer sheath, inner sheath, and stent assembly. The stent can be partially sheathed in the inner sheath while remaining accessible for deployment, allowing storage without complete crimping that would damage structural integrity
Solution Approach 2:
The stent is pre-loaded into the delivery system in a partially crimped state within the inner sheath, but not fully compressed. This preliminary positioning allows for storage and transport while preserving the ability to fully deploy the stent later without damage
2Reliability
If the stent is stored in a partially sheathed configuration, then the valve remains operational, but the risk of accidental deployment increases
Solution Approach 1:
The delivery system employs dynamic locking mechanisms including triggers and a lockout mechanism that can be activated or deactivated as needed. The system transitions between locked and unlocked states based on operational requirements, allowing secure storage while maintaining deployment capability
Solution Approach 2:
A pusher element acts as an intermediary between the operator and the stent deployment mechanism. The pusher is controlled by triggers and can only advance when the lockout is disengaged, providing an intermediate control layer that prevents accidental direct contact with the deployment mechanism
3Object-affected harmful factors
If multiple triggers and lockout mechanisms are added to prevent accidental deployment, then accidental deployment is prevented, but the device complexity increases
Solution Approach 1:
Multiple safety functions are merged into integrated components. The triggers are combined with the pusher control mechanism, and the lockout mechanism is integrated with the sheath assembly. This consolidation provides multiple safety layers without proportionally increasing overall system complexity
Solution Approach 2:
The triggers serve multiple functions: they control the pusher advancement, manage the lockout mechanism, and indicate system status. This multi-functionality reduces the need for separate dedicated components for each safety feature, thereby limiting the increase in device complexity
Data Source
AI summary
Systems and methods are disclosed for delivering a stent to a lumen internal to a body of a patient and for sheathing a stent just prior to an insertion procedure. One embodiment comprises a delivery device having a partially sheathed configuration, a fully sheathed delivery configuration, and a deployed configuration. A panchor (combination pusher and anchor) is configured to engage and limit proximal and distal movement of the implantable device. An outer sheath surrounds a distal portion of an inner member and retains the implantable device near the distal end. The outer sheath is slidably moveable relative to the inner member to deploy the implantable device. Proximal movement of a trigger results in movement of the outer sheath to deploy the implantable device. A sheathing mechanism is configured to crimp and fully sheathe the implantable device prior to a deployment procedure.