Vena Cava Stabilization for Cardiac Implant Delivery
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Solution Overview
Problem
Existing systems for delivering and positioning cardiac implants, such as prosthetic heart valves, face challenges in stabilizing the delivery device during procedures, particularly when navigating through the heart's vasculature, which can lead to tissue damage and instability, especially when accessing the tricuspid or mitral valves.
Innovation Solution
A system comprising a delivery device with an outer and inner catheter, along with a stabilization device that includes a distal end fixably connected to the outer catheter and a proximal end that can bulge outwardly or be supported by expandable mesh or inflatable structures, allowing for precise positioning and deployment of the implant within the heart valve annulus while minimizing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a catheter-based delivery system is used to deliver prosthetic valves percutaneously, then the procedure is less invasive and recovery is faster, but the delivery device becomes difficult to stabilize and position precisely within the heart valve
Solution Approach 1:
The stabilization device acts as an intermediary between the delivery catheter and the heart valve anatomy. It provides a larger surface area that can engage with the vena cava and atrial wall to stabilize the delivery system, enabling precise positioning without requiring more invasive surgical access
Solution Approach 2:
The stabilization device extends the delivery system into additional spatial dimensions by deploying structures that engage with surrounding anatomical features (vena cava, atrial wall). This multi-dimensional engagement provides stability that cannot be achieved by the catheter alone within the vascular lumen
2Measurement precision
If the delivery device is made more stable by increasing its size or structure, then positioning precision improves, but the risk of tissue damage during navigation increases
Solution Approach 1:
The stabilization function is segmented from the delivery catheter itself, allowing the catheter to remain small and flexible for safe navigation, while the separate stabilization device provides precision positioning when deployed at the target site
Solution Approach 2:
The stabilization device transitions from a compressed delivery state to an expanded deployed state only when needed for positioning. This dynamic deployment allows the system to remain minimally invasive during navigation while providing stability during the brief positioning phase
3Ease of operation
If the stabilization device is deployed early to improve stability, then positioning control improves, but the device complexity and procedure time increase
Solution Approach 1:
The stabilization device is integrated with the existing delivery catheter system, sharing common components such as the inner catheter support and deployment mechanisms. This merging reduces overall complexity compared to using entirely separate stabilization equipment
Data Source
AI summary
Aspects of the disclosure relate to systems, delivery devices and method for transcatheter delivery of a cardiac implant such as a prosthetic heart valve. Systems of the disclosure are configured to support the delivery device in an inferior vena cava and/or superior vena cava to reduce the potential for damage to heart tissue during delivery of the implant as the delivery device is articulated through the vasculature.