Balloon Constraint Delivery for Smooth Implant Deployment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing implantable medical devices face challenges in effective constraint and deployment due to limitations in length, geometry, tensile strength, and interaction with bioactive agents, leading to issues like snagging, drug displacement, and uneven deployment.
Innovation Solution
A scalable delivery system using an expandable sheath with a constraining member and differential mechanism to ensure smooth deployment, protecting devices from shear forces and maintaining bioactive coatings, accommodating various device configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a fiber constraint is used to constrain the implantable device, then the device can be delivered through minimally invasive procedures, but the fibrous cover may not smoothly mount and/or deploy from certain device geometries (e.g., fibers may catch on barbs or other features)
Solution Approach 1:
The patent replaces the fibrous constraint with a smooth, flexible balloon catheter that can conform to various device geometries without catching on features like barbs. The balloon acts as a flexible shell that envelops the compressed device and can be inflated to deploy it smoothly regardless of the device's specific geometry.
Solution Approach 2:
Instead of having the device penetrate through a fibrous constraint (as in prior art), the patent inverts the approach by having the constraint (balloon) envelop the device from the outside. This reversal allows the smooth external surface of the balloon to interface with the device, eliminating the problem of fibers catching on device features.
2Ease of manufacture
If a funnel is used to load the device, then the device can be constrained, but pulling a drug coated device through the funnel runs a serious risk that bioactive agent may be removed or displaced
Solution Approach 1:
The patent applies the coating to the device before compression, and then immediately encapsulates the compressed device in the balloon catheter. This preliminary encapsulation protects the coating from damage during subsequent handling and deployment, preventing loss of the bioactive agent.
Solution Approach 2:
The balloon catheter serves as a protective cushion that envelops the device with its smooth interior surface. This cushioning layer prevents direct contact between the device coating and potentially damaging surfaces during loading and deployment, thereby protecting the bioactive coating from displacement or removal.
3Reliability
If the constraint tightly constrains the device, then adequate constraint is achieved, but deployment forces increase and accurate deployment becomes more difficult
Solution Approach 1:
The balloon catheter transitions from a compressed state during delivery to an inflated state during deployment. This dynamic transformation allows the constraint to be tight during delivery (when the balloon is deflated and conforming to the device) and then smoothly release during deployment (when the balloon is inflated to push the device outward), reducing the force required for deployment.
Data Source
Figure 1
Figure 2~6
Figure 4~5
AI summary
An implantable medical device deployment system is disclosed that employs both a sheath element and a constraint member to protect implantable medical devices during delivery in a body while providing simple, accurate, and reliable device deployment. The delivery system is configured so that loading and deployment forces are not directly related to device diameter, length, or design, thus allowing a more universal delivery system across various delivered device configurations and product lines. The deployment system can provide numerous benefits, include better protection for drug-coated implantable devices.