Bioprosthetic Valve Conduit Assembly for Redo Surgery
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Solution Overview
Problem
Current prosthetic heart valves with conduits face challenges such as high leakage rates, difficulty in storage due to bioresorbable sealants degrading in liquid sterilants, and the need for entire assembly removal during valve re-replacement procedures, which complicates surgical operations and patient recovery.
Innovation Solution
A valved conduit design featuring a bioprosthetic aortic heart valve connected to a tubular conduit graft, sealed with a bioresorbable material, allowing for easy assembly and disassembly with mechanical snap-fit or sewing ring connections, facilitating valve replacement and minimizing leakage through undulating collar and sewing ring configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bioprosthetic heart valves are stored in liquid preserving solution, then the valve tissue remains flexible and functional, but the bioresorbable sealant in the conduit degrades and washes out
Solution Approach 1:
The valve and conduit are separated into independent components with different storage requirements. The valve is stored in liquid preserving solution while the conduit is stored dry, allowing each component to be optimized for its specific storage needs without compromising the other
Solution Approach 2:
A dry storage bag or container serves as an intermediary for the conduit, protecting the bioresorbable sealant from liquid exposure during storage while allowing the valve to be stored in its optimal liquid environment separately
2Reliability
If the entire valved conduit assembly is removed during redo operations, then complete valve replacement is achieved, but surgical complexity and patient recovery time increase
Solution Approach 1:
The valved conduit system is divided into separable components (valve and conduit) that can be independently removed and replaced. This allows the valve to be exchanged while preserving the conduit, reducing surgical complexity and patient recovery time compared to removing the entire assembly
Solution Approach 2:
The connection between the valve and conduit is designed to be dynamically adjustable, allowing for easy disconnection and reconnection during surgical procedures. This dynamic interface enables quick valve replacement without requiring complete assembly removal
3Reliability
If non-bioresorbable sealant layers are used in conduits, then sealing performance is improved, but conduit wall thickness increases and flexibility decreases
Solution Approach 1:
The sealant material undergoes parameter changes over time, transitioning from a non-porous sealed state during storage to a progressively more porous state as it bioresorbs in the body. This allows the conduit to maintain excellent sealing performance initially while gradually becoming more flexible and compliant with natural tissue as the sealant degrades
Solution Approach 2:
The conduit is constructed as a composite structure combining porous tubular material (such as woven polyester) with bioresorbable sealant. This composite approach provides both the structural integrity needed for sealing and the flexibility required for natural movement, avoiding the need for thick non-bioresorbable layers
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
The design enhances implant simplicity, reduces leakage, and allows for straightforward valve replacement during redo operations, improving surgical efficiency and patient outcomes by maintaining the functionality of the bioprosthetic valve during extended storage and simplifying the assembly process.
Implementation Method 1
the sealant medium eventually degrades by hydrolysis when exposed to water after implant and are replaced by natural tissue ingrowth
Data Source
AI summary
A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.