Distal Capture Device for Self-Expanding Stent Delivery
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Solution Overview
Problem
Conventional self-expanding stents require significant supplemental delivery forces to navigate through the delivery catheter due to the distal leading edge radially flaring open, especially when encountering obstacles within the lumen.
Innovation Solution
A distal capture device with elastically deformable sections that constrain the distal end of the stent in a retracted state, minimizing the need for supplemental forces by transitioning between a fully expanded and retracted state to prevent flaring and facilitate smooth axial traversal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the distal leading edge of the self-expanding stent is allowed to expand radially during traversal, then the stent can maintain its self-expanding properties, but significant supplemental delivery forces are required to push past obstacles within the catheter lumen
Solution Approach 1:
The distal capture device is configured to maintain the stent in a compressed state before delivery, preventing premature radial expansion. The capture device engages the distal leading edge of the stent and constrains it axially within the catheter lumen, ensuring the stent remains compact during navigation through vessels and obstacles.
Solution Approach 2:
The distal capture device acts as an intermediary between the delivery system and the stent. It provides a mechanical interface that captures and controls the distal leading edge of the stent, allowing the delivery system to push the stent axially without the stent expanding radially. The capture device translates axial force into controlled stent advancement while maintaining compression.
2Force
If the stent is kept in a compressed state during delivery, then supplemental delivery forces are minimized, but the distal leading edge may still radially flare open when encountering obstacles
Solution Approach 1:
The distal capture device is pre-configured to engage and constrain the distal leading edge of the stent before delivery begins. This preliminary constraint prevents radial flaring when obstacles are encountered during traversal, maintaining stent configuration stability throughout the delivery process.
Solution Approach 2:
The distal capture device serves as a protective intermediary that shields the stent's distal leading edge from obstacles within the catheter lumen. By capturing and constraining the stent edge, the device prevents unwanted radial expansion while allowing smooth axial movement through the delivery system.
3Device complexity
If conventional delivery systems are used without a distal capture device, then the delivery system is simpler, but significant forces are required and the catheter may be damaged
Solution Approach 1:
The delivery system is segmented into distinct functional components: the catheter, the distal capture device, and the stent. The distal capture device is a separate element that can be attached to or integrated with the catheter, providing specialized functionality for stent engagement and control without requiring complete redesign of the entire delivery system.
Solution Approach 2:
The distal capture device is introduced as an intermediary component that bridges the catheter and stent. This addition provides the necessary control and force distribution to prevent catheter damage while maintaining reasonable system complexity. The capture device absorbs and distributes delivery forces, protecting the catheter from damage.
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 solution effectively reduces or eliminates the need for supplemental delivery forces, ensuring the stent can be advanced through the catheter without damaging it, thereby improving the delivery system's efficiency and reliability.
Implementation Method 1
one or more elastically deformable sections having a free terminating end and an opposite end mounted to the distal end of the sleeve. The elastically deformable sections transition between: (i) a fully expanded state in which the elastically deformable section is distally biased in a direction away from the sleeve; and (ii) a retracted state in which the free terminating end of each of the elastically deformable sections is proximally deflected backwards over itself
Data Source
Figure 1A~1B
Figure 2~3
Figure 4
AI summary
A delivery system including a distal capture device that has a sleeve with a passageway defined axially therethrough and one or more elastically deformable sections. Each of the one or more elastically deformable sections has a free terminating end and an opposite end mounted to the distal end of the sleeve. The elastically deformable sections transition between: (i) a fully expanded state in which the elastically deformable section is distally biased in a direction away from the sleeve; and (ii) a retracted state in which the free terminating end of each of the elastically deformable sections is proximally deflected backwards over itself in a direction toward the proximal end of the sleeve.