Marker Band Indicator for Medical Device Delivery Orientation
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Solution Overview
Problem
Existing medical device delivery systems face challenges in maintaining consistent and predictable delivery due to the tortuosity of a patient's native anatomy, often resulting in undesirable rotation of the delivery system during procedures, which can affect the accurate positioning of medical devices like valve prostheses.
Innovation Solution
Incorporating a marker band with an indicator at the distal end of the delivery system, which allows for the determination of rotational orientation relative to the central axis of the vasculature, enabling adjustment and confirmation of the correct orientation of the medical device before deployment, thereby ensuring proper alignment and reducing rotation issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery system is advanced through tortuous vasculature, then the medical device can be delivered to the target site, but the delivery system rotates undesirably during tracking
Solution Approach 1:
The marker band is attached to the delivery system capsule before the procedure begins, establishing a known reference orientation. This preliminary marking allows the operator to predict and compensate for rotation that will occur during advancement through tortuous vasculature, enabling more reliable delivery consistency despite the rotational challenge.
Solution Approach 2:
The fluoroscopically visible marker band provides continuous visual feedback about the rotational orientation of the delivery system during advancement. By observing the marker band's position relative to anatomical landmarks, the operator can detect rotation and make real-time adjustments to maintain the desired orientation, improving both delivery consistency and operational control.
2Adaptability or versatility
If the delivery system is rotated during tracking through vasculature, then the system can navigate the anatomy, but the medical device positioning accuracy deteriorates
Solution Approach 1:
The marker band includes asymmetric features such as indicators or markers at specific positions that allow differentiation of orientation. This asymmetry enables the operator to distinguish between different rotational positions (e.g., 0 degrees vs. 90 degrees) relative to anatomical landmarks, maintaining positioning accuracy even as the system adapts to navigate tortuous vasculature.
Solution Approach 2:
The marker band acts as an intermediary reference between the delivery system and the anatomical structure. By providing a visible, trackable element that maintains a known relationship to the medical device, the marker band allows the operator to indirectly monitor and control device orientation during navigation through complex anatomy, preserving positioning accuracy.
3Productivity
If the medical device is deployed without orientation confirmation, then the procedure time is reduced, but the likelihood of paravalvular leakage increases
Solution Approach 1:
The marker band is pre-positioned on the delivery system with known orientation relationships to the medical device. Before deployment, the operator can verify the correct orientation by checking the marker band's position relative to fluoroscopic landmarks, ensuring accurate placement while maintaining procedural efficiency. This preliminary orientation check prevents the need for corrective maneuvers after deployment.
Solution Approach 2:
The visible marker band provides real-time feedback about device orientation during the deployment process. The operator can confirm correct alignment with anatomical structures (such as native leaflets for valve replacement) before releasing the device, thereby ensuring high placement accuracy and minimizing paravalvular leakage while maintaining acceptable procedure timing.
Data Source
AI summary
A delivery system for delivering a medical device through a vasculature can include a capsule for housing the medical device during delivery and a marker band rotatably fixed to the capsule. The marker band can include a band portion and a single indicator protruding from the band portion. The indicator can allow the rotational orientation of the marker band to be determined while the medical device is in the vasculature, the rotational orientation being around a central axis of the vasculature. A delivery system for delivering a medical device through a vasculature includes a capsule for housing the medical device during delivery and a marker band attached to a proximal end of the capsule. The marker band can include a base portion and a protrusion that can be configured to extend from the base portion towards a distal end of the capsule. Related methods are also described.