Segmented Cardiac Valve Delivery System for Trans-Apical Positioning
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Solution Overview
Problem
Current minimally invasive cardiovascular surgery techniques face challenges in accessing heart valves due to limited space within the vasculature, leading to difficulties in accurately and precisely delivering prosthetic valves, especially during trans-apical procedures, where catheters lack rigidity and are prone to twisting, making it hard to navigate and position valves correctly.
Innovation Solution
The use of a Scapus™ delivery system, which is a substantially rigid and elongated rod-like structure that can be used to deliver prosthetic valves through the apex of the heart, providing greater access and allowing for precise longitudinal and rotational positioning, and can incorporate imaging transducers for better visualization during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If catheters are used for minimally invasive valve delivery, then patient trauma is reduced, but device positioning precision deteriorates due to catheter flexibility and twisting
Solution Approach 1:
The delivery system is divided into multiple segments including a catheter portion for navigation and a rigid delivery member portion for precise valve positioning. This segmentation allows the system to combine the advantages of flexible catheter access with rigid positioning accuracy, resolving the contradiction between minimizing patient trauma and ensuring precise valve placement.
Solution Approach 2:
The delivery system changes its physical parameters along its length, transitioning from a flexible catheter configuration suitable for vascular navigation to a substantially rigid delivery member configuration that provides stability and precision during valve implantation. This parameter change enables the system to address both patient trauma reduction and positioning precision requirements.
2Area of moving object
If percutaneous approach is used, then incision size is minimized, but surgical field access deteriorates due to limited vascular space
Solution Approach 1:
The delivery system employs a nested structure where the prosthetic valve is crimped onto the delivery member, which is itself positioned within the catheter. This nesting allows the entire valve delivery assembly to be compressed to a small diameter for percutaneous insertion while maintaining the capability to deploy the full-sized valve at the target site, thus preserving both minimal incision size and adequate surgical field access.
Solution Approach 2:
The delivery system transitions dynamically from a compressed, flexible state during insertion to an expanded, rigid state during valve deployment. This dynamic transformation allows the system to navigate through narrow vascular passages with minimal incision while providing sufficient surgical field access once positioned at the heart valve site.
3Ease of operation
If trans-apical procedure is used, then direct heart access is improved, but device navigation difficulty increases due to lack of rigidity in catheters
Solution Approach 1:
The delivery system is segmented into a catheter portion for initial navigation to the heart and a rigid delivery member portion for precise valve delivery through the apex. This segmentation reduces navigation difficulty by providing structural support in the critical delivery zone while maintaining flexibility for access, thereby improving ease of operation without excessive device complexity.
Solution Approach 2:
The delivery member acts as an intermediary between the flexible catheter and the rigid prosthetic valve. It provides the necessary rigidity for precise positioning and stable valve deployment during trans-apical procedures, while the catheter portion maintains flexibility for navigation, thus simplifying overall device navigation compared to using a completely rigid system.
Data Source
AI summary
The present invention provides systems and methods for the repair, removal, and/or replacement of heart valves. The methods comprise introducing a delivery system into the heart, wherein a prosthesis is disposed on the delivery member attached to the delivery system, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery member at the target site for implantation. The present invention also provides implant systems for delivering a prosthesis to a target site in or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system, and a prosthesis.