Pericardial Tissue Thinning for Uniform Heart Valve Leaflets
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Solution Overview
Problem
Existing methods for preparing bioprosthetic heart valve leaflets from bovine pericardial tissue are inefficient, time-consuming, and result in inconsistent thickness, limiting the yield and suitability for minimally invasive delivery systems.
Innovation Solution
A method involving the selection of bovine pericardial membrane, smoothing and thinning the fibrous side using mechanical devices or laser ablation, and cross-linking the membrane under compression to achieve uniform thickness, which can be further treated with capping and borohydride reduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional manual measurement and trimming methods are used, then the process is simple to operate, but the manufacturing precision of tissue thickness is poor and productivity is low
Solution Approach 1:
The patent replaces manual mechanical measurement and trimming with automated laser-based thickness measurement and controlled material removal systems. The laser measurement system provides precise non-contact thickness measurement, while automated control systems regulate the trimming process to achieve uniform thickness across the tissue sheet, eliminating the imprecision of manual operations.
Solution Approach 2:
The tissue processing system incorporates automated feedback control where thickness measurements are taken continuously during processing, and the system automatically adjusts processing parameters to maintain target thickness. This self-regulating mechanism ensures consistent thickness uniformity without requiring constant manual intervention or complex operator skills.
2Manufacturing precision
If extensive manual processing and quality control are performed, then manufacturing precision can be improved, but the processing time increases significantly
Solution Approach 1:
The patent implements continuous automated processing where laser thickness measurement, marking, and trimming operations are performed in an uninterrupted sequence without manual repositioning or measurement between steps. The automated system maintains continuous control over the tissue sheet, eliminating idle time and achieving both high precision and rapid processing.
Solution Approach 2:
Manual measurement and quality control steps are replaced by automated optical measurement systems and computer-controlled processing. The system continuously monitors thickness and automatically adjusts parameters, eliminating the time-consuming manual inspection and adjustment cycles while maintaining or improving precision.
3Strength
If thicker tissue is used to ensure durability, then valve durability is improved, but the tissue cannot be delivered through minimally invasive systems
Solution Approach 1:
The patent precisely controls tissue thickness as a critical parameter, reducing it to optimal values that enable minimally invasive delivery while maintaining sufficient structural integrity. Through automated measurement and controlled material removal, the system achieves thickness values that balance deliverability requirements with durability needs, eliminating the need to use excessively thick tissue.
Solution Approach 2:
The patent employs controlled compression of the tissue during processing to achieve uniform thinning while maintaining structural integrity. Compression allows the tissue to be delivered through smaller catheters while preserving the mechanical properties needed for durability, effectively decoupling thickness reduction from strength loss.
4Productivity
If inconsistent tissue thickness is produced, then processing speed can be maintained, but the yield of usable leaflets per sac decreases
Solution Approach 1:
The patent incorporates real-time thickness measurement feedback that guides the processing system to maintain consistent thickness across the entire tissue sheet. The measurement data is fed back to control the material removal process, ensuring that all portions of the tissue meet specification requirements and can be used as usable leaflets, thereby maximizing yield without sacrificing processing speed.
Solution Approach 2:
The automated system performs self-regulation of thickness uniformity through continuous monitoring and automatic parameter adjustment, eliminating the need for slow manual quality checks between processed sections. This maintains high processing speed while ensuring consistent thickness that maximizes the number of usable leaflets obtained from each sac.
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
This process increases the yield of usable heart valve leaflets per sac, reduces thrombogenic agents, and enables smaller, more consistent thicknesses suitable for minimally invasive procedures, enhancing the durability and efficiency of bioprosthetic valves.
Implementation Method 1
smoothing and thinning the fibrous side using mechanical devices or laser ablation
Implementation Method 2
chemically fixed to crosslink collagen and elastin molecules in the tissue and increase the tissue durability
Data Source
AI summary
Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smooths the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.