Balloon Nosecone Length Adjustment for Minimally Invasive Valve Delivery
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Solution Overview
Problem
Current minimally invasive cardiac valve replacement procedures face challenges with large prosthetic heart valves requiring correspondingly large delivery devices, which can be traumatic and costly, and often necessitate open-heart surgery, especially for patients intolerant of such procedures due to age or illness.
Innovation Solution
A delivery system comprising a collapsible and expandable prosthetic heart valve deployment system with a nosecone that can be inflated or deflated to adjust length, allowing for a smaller profile for navigation through the femoral vein and easier maneuverability within the heart, along with a suture rigging assembly for secure attachment and deployment of the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large prosthetic heart valve is used to replace a damaged valve, then the valve replacement is effective, but the delivery device becomes large and causes more trauma
Solution Approach 1:
The delivery device employs a nested configuration where the prosthetic heart valve is collapsed and positioned within a delivery catheter. The valve frame is compressed to a small profile that fits inside the catheter lumen, allowing the large valve to be transported through small vessels without requiring a large delivery device, thus reducing procedural trauma.
Solution Approach 2:
The delivery system utilizes a collapsible and expandable valve mechanism. The valve frame can be dynamically compressed to a small size for delivery through the catheter, then expanded to its full functional size at the deployment site. This dynamic transformation allows the valve to transition from a compact transport state to a functional large-size state, resolving the contradiction between valve size and delivery device size.
2Adaptability or versatility
If a large delivery device is used to deliver a large prosthetic heart valve, then the valve can be delivered, but the procedure becomes more complex and costly
Solution Approach 1:
The delivery system uses a nested catheter configuration where multiple components (guidewire, valve, compression mechanism) are arranged concentrically within a single catheter. This nested arrangement allows the system to deliver large valves through a unified small-profile catheter, simplifying the overall device structure while maintaining delivery capability for large valves.
Solution Approach 2:
The delivery catheter is designed as a multi-functional device that can perform multiple operations: guiding the valve to the target location, compressing the valve frame to the delivery position, and facilitating valve deployment. This consolidation of functions into a single device reduces system complexity compared to having separate devices for each function.
3Object-affected harmful factors
If a small delivery catheter is used to deliver a large prosthetic heart valve, then procedural trauma is reduced, but the valve cannot be delivered
Solution Approach 1:
The valve frame is designed with dynamic compressibility, allowing it to be collapsed to a small profile that fits within a small delivery catheter during transport. At the deployment site, the valve is expanded to its full size to function as a large prosthetic valve. This dynamic size change enables the delivery of large valves through small catheters, simultaneously achieving reduced trauma and maintained delivery capability.
Solution Approach 2:
The valve frame is segmented into collapsible elements that can be compressed individually to reduce the overall valve profile. This segmentation allows the valve structure to be broken down into a compact configuration for delivery, then reassembled to its full functional size at the target location, enabling delivery through small catheters.
4Reliability
If open-heart surgery is performed for valve replacement, then the valve can be replaced effectively, but the patient faces high costs and significant trauma
Solution Approach 1:
The system replaces the mechanical open-heart surgery approach with a minimally invasive catheter-based delivery system. Instead of requiring surgical incisions, chest opening, and direct manipulation of the heart, the valve is delivered through a small catheter inserted via a peripheral access point, substituting complex mechanical surgery with a simpler minimally invasive mechanical delivery system.
Solution Approach 2:
The delivery catheter acts as an intermediary that bridges the gap between the prosthetic valve and the heart valve annulus. Rather than directly opening the heart to implant the valve, the catheter serves as a mediator to transport and deploy the valve through the vascular system, eliminating the need for open-heart surgery and its associated trauma and costs.
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
Enables the delivery of large prosthetic heart valves through smaller catheters, reducing procedural trauma and costs, and allowing for minimally invasive procedures without the need for open-heart surgery, improving patient safety and outcomes.
Implementation Method 1
a nosecone that has a length that may be adjusted by pushing an inflation medium into the balloon nosecone or withdrawing the inflation medium from the balloon nosecone via the inflation lumen
Data Source
AI summary
A delivery system for delivering a medical device includes a delivery device. The delivery device may include an outer delivery sheath having a compartment at a distal end thereof, the compartment configured to receive the medical device. The delivery device may also include a nosecone catheter positioned radially within the outer delivery sheath, the nosecone catheter having an inner tube configured to receive a guidewire therethrough, and an outer tube, an inflation lumen defined between the inner tube and the outer tube. The delivery device may further include a nosecone that has a length that may be adjusted by pushing an inflation medium into the balloon nosecone or withdrawing the inflation medium from the balloon nosecone via the inflation lumen, the balloon nosecone being reversibly coupled to the nosecone catheter.