Trans-aortic Delivery System with Centering Capsule
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Solution Overview
Problem
Current methods for replacing cardiac valves require prolonged hospitalization and extensive recovery due to the need for cardiopulmonary bypass and invasive procedures, and existing catheter-based delivery systems face challenges in precise deployment and retraction of prosthetic valves.
Innovation Solution
A trans-aortic delivery system with a two-part prosthesis containment capsule and a handle assembly featuring control mechanisms for precise deployment and retraction, including a safety stop feature and centering elements like self-expanding frames or funnels to facilitate accurate placement and safe removal of heart valve prostheses without cardiopulmonary bypass.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open-heart surgery with cardiopulmonary bypass is used for valve replacement, then complete valve replacement can be achieved, but patient recovery time is prolonged and the procedure is more invasive
Solution Approach 1:
The delivery system is divided into separate components including an outer catheter, inner catheter, containment capsule, and deployment mechanisms that can be independently controlled. This segmentation allows for minimally invasive delivery through peripheral vessels while maintaining the ability to achieve complete valve replacement, avoiding the need for open-heart surgery and reducing recovery time
Solution Approach 2:
A containment capsule serves as an intermediary device that holds the compressed prosthetic valve during delivery through the aorta. The capsule can be precisely positioned and then opened to deploy the valve at the target location, enabling minimally invasive replacement while ensuring complete valve substitution
2Loss of time
If catheter-based delivery systems are used for minimally invasive valve implantation, then recovery time is reduced, but precise deployment and retraction control becomes challenging
Solution Approach 1:
The system replaces manual mechanical manipulation with controlled mechanical mechanisms including a first control mechanism for the outer catheter and a second control mechanism for the inner catheter. These mechanisms provide precise, reproducible control of catheter movement and capsule deployment, improving operational ease while maintaining minimal invasiveness
Solution Approach 2:
The system utilizes controlled changes in catheter position, capsule orientation, and deployment timing parameters to achieve precise valve placement. By systematically controlling these parameters through dedicated control mechanisms, the system enables accurate deployment and retraction while maintaining minimally invasive benefits
3Measurement precision
If a containment capsule is used to deliver the prosthetic valve, then precise delivery is achieved, but quick and accurate retraction of the distal portion becomes difficult
Solution Approach 1:
The containment capsule is designed with dynamic characteristics that allow it to be held in a controlled open state during precise valve deployment, then quickly transition to a closed state for rapid retraction. The capsule's distal portion can be independently controlled to open and close, enabling both precise delivery and quick retraction without compromise
4Manufacturing precision
If self-expanding frames or funnels are added as centering elements, then accurate valve placement is improved, but device complexity increases
Solution Approach 1:
Self-expanding frames or funnels are incorporated as centering elements that automatically assume their functional shape when deployed, providing accurate valve centering without requiring complex external manipulation or additional control mechanisms. The self-expanding nature simplifies the overall system while improving placement accuracy
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 quick and accurate implantation of prosthetic heart valves directly in the aorta, reducing recovery time and minimizing tissue damage, while allowing for precise control and safe retraction of the delivery system through the deployed valve.
Implementation Method 1
capsule centering element such as, but not limited to, a self-expanding frame, a self-expanding funnel, or a centering shaft
Data Source
AI summary
Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly which can include a first control mechanism, a second control mechanism, and a decoupling mechanism. The delivery systems can also include a delivery catheter extending from the handle assembly. The delivery catheter can include an outer shaft, which can be controlled by the first control mechanism; a prosthesis containing capsule comprising a proximal capsule portion connected to the outer shaft, and a distal capsule portion releasably coupled to the proximal capsule portion. After deploying a valve prosthesis, the capsule can be closed by activating the decoupling mechanism in the handle to rapidly close the distal and proximal capsule portions together. The delivery system can also include a centering element to guide the distal and proximal capsule portions together.