Compressible Tip for Medical Implant Delivery System
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Solution Overview
Problem
Conventional delivery systems for collapsible prosthetic heart valves face challenges in precisely positioning the valve during transfemoral implantation, as the distal sheath often contacts and damages the aortic arch or calcified tissue, leading to potential embolism and other adverse effects.
Innovation Solution
A delivery system featuring a tip with a compressible material and variable diameter, which changes from a compressed to an expanded state, allowing it to avoid contact with the aortic arch and calcified tissue by maintaining a larger diameter than the sheath, thereby minimizing tissue engagement during navigation through the vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the distal sheath is advanced through the aortic arch using a conventional delivery system, then the prosthetic valve can be delivered to the target site, but the distal end of the sheath contacts and damages the aortic arch and calcified tissue, causing embolism risk
Solution Approach 1:
A tip made of compressible material is attached to the distal end of the support member before delivery. This tip acts as a cushion that prevents direct contact between the hard distal sheath and the aortic arch tissue, absorbing mechanical stresses and preventing tissue damage and embolism during the delivery process
Solution Approach 2:
The compressible tip serves as an intermediary element between the distal sheath and the aortic arch tissue. It mediates the interaction by providing a compliant interface that protects the delicate aortic arch and calcified tissue from direct contact with the rigid delivery system components
2Ease of operation
If the distal sheath has a small diameter to navigate through the vasculature, then it can pass through the aortic arch, but it cannot effectively prevent contact with the aortic arch wall
Solution Approach 1:
The tip is designed to be dynamically compressible, allowing it to be compressed to a small diameter during navigation through the vasculature and aortic arch, then expand to a larger diameter at the target site to prevent contact with the aortic arch wall and provide effective protection
Solution Approach 2:
The compressible tip can be compressed to fit within the confines of the distal sheath during delivery, then expand outward to provide protection, similar to a nested doll that changes size to adapt to different spatial requirements
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 system effectively reduces contact with body tissue, minimizing damage and embolism risk, enabling safer and more precise deployment of prosthetic heart valves by maintaining a larger diameter than the sheath, thus avoiding engagement with the aortic arch and calcified tissue.
Implementation Method 1
a tip (132) made at least partly of a compressible material... the tip having a compressed condition, an expanded condition, and a variable diameter along a length thereof
Data Source
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AI summary
A delivery system for delivering and deploying a medical implant, such as a prosthetic heart valve, includes an elongated support member (28), a sheath (30), and a tip (132). The sheath is movable relative to the elongated support member between a distal position overlying the medical implant and a proximal position exposing the medical implant for release from the delivery system. The tip is attached to the elongated support member and is positioned at a distal end of the sheath when the sheath is in the distal position. The tip has a compressed condition and an expanded condition, and a maximum diameter in the expanded condition that is larger than the outer diameter of the sheath.