Sleeve Retraction System for Endoluminal Devices
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Solution Overview
Problem
Conventional endoluminal devices face challenges in preventing inadvertent obstruction of branch vessels due to the inability of existing imaging technologies to detect flexible sleeves, which lack radioopaque markers and do not correlate with device markers, necessitating a system for sleeve retraction after deployment.
Innovation Solution
A sleeve retraction system comprising a sleeve, deployment lines, and sleeve pull back lines that allow for partial or full retraction of the sleeve after device deployment, utilizing materials like ePTFE and high-strength polymer fibers, with engagement mechanisms such as z-pattern threading and independent release lines to control retraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a flexible sleeve is used to constrain the endoluminal device during delivery, then the device can be delivered through the vasculature in a compressed state, but the sleeve may inadvertently obstruct branch vessels after deployment
Solution Approach 1:
The sleeve is retracted before the endoluminal device is fully deployed, ensuring the device is properly positioned and expanded before the sleeve is removed from the treatment site. This preliminary retraction action prevents the sleeve from obstructing branch vessels while maintaining its constraining function during delivery.
Solution Approach 2:
The system separates the sleeve retraction function from the device deployment function by using independent pull back lines and release mechanisms. This allows the sleeve to be retracted independently after device deployment, enabling controlled removal without affecting the deployed device or obstructing branch vessels.
2Productivity
If conventional imaging technologies are used to monitor device deployment, then the procedure can be visualized, but the imaging technologies cannot detect the flexible sleeve or its position
Solution Approach 1:
Radioopaque markers are incorporated into the sleeve at specific locations (such as at the ends or at intervals along the sleeve) to make the otherwise radiolucent sleeve visible under fluoroscopic imaging. These markers change the radiopacity of the sleeve in specific regions, allowing clinicians to track sleeve position and retraction status using conventional imaging technologies.
Solution Approach 2:
Radioopaque markers serve as intermediaries between the flexible sleeve and the imaging system. Since the sleeve material itself is not detectable by conventional imaging, these markers act as mediators that reflect or attenuate X-rays, making the sleeve's position and movement visible without requiring the sleeve material itself to be imaging-visible.
3Device complexity
If the sleeve is left in situ after device deployment, then the delivery system can be simplified, but branch vessels may be inadvertently obstructed by the remaining sleeve
Solution Approach 1:
The sleeve is retracted to a predetermined position before device deployment is complete, ensuring that the device is fully deployed and secured before the sleeve is removed from the treatment site. This preliminary retraction prevents the sleeve from obstructing branch vessels while maintaining system simplicity by using pre-configured release mechanisms.
4Difficulty of detecting and measuring
If radioopaque markers are added to the sleeve to improve detectability, then the sleeve position can be visualized, but the markers may not correlate with the actual ends of the sleeve
Solution Approach 1:
Radioopaque markers are strategically placed at the ends of the sleeve and at known intervals along its length, creating a predictable pattern that correlates with the sleeve's physical structure. This allows clinicians to accurately determine sleeve position and orientation by observing the spatial relationship between markers under fluoroscopic imaging.
Data Source
AI summary
The present disclosure describes systems for endoluminal devices utilizing a sleeve for constraining an expandable device toward a constrained configuration suitable for endoluminal delivery to a treatment site along vasculature; and a mechanism for retracting at least a portion of the sleeve.