Trans-aortic Valve Introducer System Design
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Solution Overview
Problem
Current methods for replacing a deficient cardiac valve often require cardiopulmonary bypass and sternotomy, leading to prolonged hospitalization and painful recovery, while minimally invasive approaches may still necessitate these invasive procedures.
Innovation Solution
A trans-aortic valve introducer system that allows for one-handed, single-shot deployment of a prosthetic valve without cardiopulmonary bypass, using a delivery shaft with a distal tip and deployment element to accurately position and deploy the valve within the aorta.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If classic sternotomy technique is used, then accurate positioning of prosthetic valve is achieved, but patient requires prolonged hospitalization and extensive recovery
Solution Approach 1:
The delivery system is divided into separate functional components: an outer introducer sheath for access, an inner delivery catheter for valve transport, and a deployment mechanism for valve release. This segmentation allows the valve to be delivered through a minimally invasive trans-aortic approach while maintaining precise positioning control, avoiding the need for full sternotomy and cardiopulmonary bypass
Solution Approach 2:
The patent introduces a trans-aortic introducer sheath as an intermediary access route between the femoral artery and the aortic valve. This intermediary pathway allows the delivery catheter to reach the aortic valve position accurately without requiring sternotomy or cardiopulmonary bypass, thus reducing hospitalization time while maintaining positioning precision
2Loss of time
If minimally invasive catheter-based approach is used, then hospitalization time is reduced, but accurate positioning of prosthetic valve becomes more difficult
Solution Approach 1:
The delivery catheter is pre-shaped with a curved distal end that naturally follows the anatomical path from the femoral artery through the aortic arch to the ascending aorta. This preliminary shaping ensures accurate positioning at the aortic valve without requiring complex navigation during the procedure, maintaining positioning precision while enabling minimally invasive access
Solution Approach 2:
The patent replaces the mechanical steering controls of traditional catheters with a pre-formed curved delivery catheter that uses its own geometry to navigate to the target. This substitution eliminates the need for complex mechanical manipulation during positioning, maintaining accuracy while simplifying the minimally invasive approach
3Reliability
If traditional two-handed deployment is used, then control is maintained, but deployment time increases and efficiency decreases
Solution Approach 1:
The deployment mechanism combines the push rod actuation and release functions into a single integrated mechanism controlled by one thumb. The push rod is directly connected to the valve release mechanism, allowing simultaneous control of valve推送 and release with a single hand motion, thus improving deployment speed while maintaining reliability through the simple mechanical connection
4Device complexity
If trans-aortic approach is used, then cardiopulmonary bypass is avoided, but device complexity increases
Solution Approach 1:
The trans-aortic introducer system is designed as a universal platform that can deliver both self-expanding and balloon-expandable valve prostheses. The system includes a standardized introducer sheath, delivery catheter, and deployment mechanism that work with multiple valve types, allowing avoidance of cardiopulmonary bypass for various valve replacement scenarios without requiring different complex systems
Data Source
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AI summary
Prosthetic valve introducer systems (100) and methods for deploying a heart valve prosthesis within a body lumen are disclosed. In certain embodiments, the valve introducer can include a delivery shaft (110) to house a prosthetic valve and a distal tip (114), and a deployment element to push a prosthetic valve out of the distal tip of the delivery shaft. The valve introducer can include at least one finger gripping element (10). The delivery shaft can be inserted into a body lumen and advanced to a desired deployment location. In certain embodiments, the prosthetic valve can be deployed by pushing the deployment element in a distal direction, thereby pushing the prosthetic valve out of the distal tip of the delivery shaft.