Medical Balloon Roll-Sock Sheath for Coating Protection
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Solution Overview
Problem
Current medical balloon technologies face challenges in maintaining the integrity of bioactive coatings during deployment, leading to potential loss of the coating material and reduced effectiveness in preventing restenosis and acute occlusion during angioplasty procedures, due to friction and delayed drug delivery.
Innovation Solution
A coated medical balloon assembly featuring a roll-sock sheath with a hydrophilic or lubricous outer layer that protects the bioactive material coating, allowing for direct application to the vessel wall without delay, while minimizing friction and ensuring precise deployment, using a mechanism that retracts the outer layer to expose the balloon for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a bioactive coating is applied to the medical balloon, then the effectiveness in preventing restenosis and acute occlusion is improved, but the coating integrity is compromised due to friction during deployment
Solution Approach 1:
The patent applies a protective coating to the balloon surface before the bioactive coating is deposited. This preliminary protective layer is designed to withstand the friction and mechanical stresses of catheter insertion and deployment, while still allowing the bioactive coating to adhere and transfer effectively to the vessel wall during the procedure.
Solution Approach 2:
The patent employs a composite coating structure consisting of multiple layers: a base protective coating layer that provides mechanical durability, and an outer bioactive coating layer that contains the therapeutic agents. This composite structure allows each layer to perform its specific function - the base layer protects against friction and damage, while the bioactive layer maintains its integrity and delivers the therapeutic effect.
2Productivity
If the balloon is deployed directly without protection, then the bioactive coating can be applied directly to the vessel wall, but friction during insertion causes coating loss and delayed drug delivery
Solution Approach 1:
The protective coating is applied in advance to the balloon surface before the bioactive coating is deposited. This preliminary layer serves as a protective barrier during the insertion and deployment process, preventing premature loss of the bioactive material while still allowing for effective drug transfer to the vessel wall when the balloon is inflated against the lesion.
Solution Approach 2:
The protective coating acts as an intermediary layer between the bioactive coating and the external environment (catheter friction, blood flow). This intermediary layer protects the bioactive materials during insertion and deployment, reducing coating loss while maintaining the ability to deliver the therapeutic agent to the vessel wall when needed.
3Stability of the object's composition
If a protective layer is added to the balloon, then coating integrity is maintained, but the device complexity increases
Solution Approach 1:
The protective coating is implemented as a thin film layer on the balloon surface rather than a bulky structural component. This thin film approach maintains coating integrity while minimizing the increase in device complexity and overall device dimensions, allowing the balloon to remain flexible and functional.
Solution Approach 2:
The patent uses a composite coating structure where multiple functional layers are combined in a integrated manner. The base protective layer and bioactive coating layer work together as a unified system, where the protective layer enables the bioactive layer to maintain integrity without requiring separate protective mechanisms or complex additional components.
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 maintains the bioactive coating integrity, reduces drug loss, and ensures timely delivery of the therapeutic agent to the vessel wall, enhancing the prevention of restenosis and acute occlusion, and facilitating smoother balloon deployment through vascular lesions.
Implementation Method 1
a coating of hydrophilic or lubricous material on an outer surface of the second roll-sock layer
Data Source
AI summary
An introducer assembly includes a balloon catheter, a medical balloon at the distal end of the catheter. On the outside of the balloon catheter and medical balloon is a roll-sock sheath. The sheath is in formed of two layers able to slide over one other extending towards the proximal end of the assembly. The roll-sock sheath extends to a distal fold line which, before employment, extends over at least a portion of dilator tip and covers completely the medical balloon. The roll-sock sheath can be pulled back by withdrawing the outer layer of the roll-sock sheath, gradually to expose the medical balloon. A hydrophilic coating is provided on the outer surface of the outer layer of the roll-sock sleeve, which promotes the pushability of the balloon catheter assembly through a lesion. The coating makes it easier to push the distal end of the catheter assembly through a lesion, reduces friction between the lesion and the distal end of the balloon catheter assembly. The balloon remains protected by the roll-sock sleeve as does the coating of drug, which is exposed only just prior to deployment, once the balloon is in position.