Balloon delivery system for the implant deployment
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Solution Overview
Problem
Existing stent deployment systems face challenges with stent sizing difficulties such as under-expansion or malapposition, leading to restenosis and subacute thrombosis in percutaneous coronary intervention (PCI), particularly with bioresorbable vascular scaffolds (BVS).
Innovation Solution
A balloon delivery system (BDS) with a sheath and stopper mechanism to restrain the BVS, preventing repositioning and self-expansion, combined with a balloon for controlled expansion, ensuring optimal deployment of BVS in coronary arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a conventional stent deployment system is used, then the stent can be deployed in the coronary artery, but stent sizing difficulties occur leading to under-expansion or malapposition
Solution Approach 1:
The patent introduces a balloon as an intermediary device between the stent and the delivery system. The balloon serves as a mediator that transmits controlled expansion force to the stent, enabling precise dimensional control during deployment. This resolves the contradiction by providing a controlled expansion mechanism that ensures both precision and reliability in stent deployment.
Solution Approach 2:
The patent employs parameter changes by controlling the balloon inflation pressure and volume to achieve precise stent expansion. By adjusting the expansion parameters (pressure, volume, duration), the system achieves accurate stent sizing and positioning, resolving the contradiction between expansion precision and deployment reliability.
2Ease of operation
If the implant is self-expanding, then deployment is simplified, but the implant may fail to maintain sufficient friction force with the sheath
Solution Approach 1:
The patent uses pneumatic pressure through balloon inflation to enhance friction force between the implant and sheath. By inflating the balloon, radial pressure is applied to press the implant against the sheath wall, generating sufficient friction force to prevent premature expansion during delivery while maintaining deployment simplicity.
3Ease of operation
If the sheath is retracted to expose the implant, then deployment is enabled, but the implant may move toward the proximal end of the catheter
Solution Approach 1:
The patent replaces the traditional mechanical stopper system with a friction-based retention mechanism. The friction force between the implant and sheath, enhanced by balloon inflation pressure, substitutes for mechanical stopping mechanisms, allowing sheath retraction for implant exposure while maintaining precise implant positioning through controlled friction.
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 BDS ensures precise and controlled deployment of BVS, reducing restenosis and thrombosis risks by maintaining the scaffold in the desired conformation and expanding it accurately at the treatment site.
Implementation Method 1
a balloon for controlled expansion
Implementation Method 2
expanding it accurately at the treatment site
Implementation Method 3
the friction force between the sheath, the implant, and the stents are designed to bold them in place with respect to each other
Implementation Method 4
a sheath that extends longitudinally around the catheter and envelops the implant; wherein the stopper prevents movement of the implant
Data Source
AI summary
Provided herein are balloon delivery systems (BDSs) for deploying expandable implants at treatment locations within a subject. In particular provided herein are BDSs providing optimal deployment of bioresorbable vascular scaffolds (BVS). for example. within a coronary artery.