Ex Vivo Pericardial Tissue Conditioning Blade Assembly
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Solution Overview
Problem
Current methods for preparing ex vivo pericardial tissue for prosthetic heart valves are inefficient in removing fibers, which can affect the tissue's quality and functionality.
Innovation Solution
A blade assembly with a motor-driven blade array is used to shear fibers from the fibrous side of the tissue, submerged in a liquid bath, with a suction system to collect and flush away the removed fibers, allowing for efficient fiber removal and tissue conditioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional fiber removal methods are used on ex vivo pericardial tissue, then the process is simpler in terms of equipment, but the fiber removal efficiency is low and tissue quality is compromised
Solution Approach 1:
The blade head is divided into multiple cutting blades arranged in a specific pattern, with each blade contributing to fiber removal. The segmentation of the cutting function across multiple blades increases fiber removal efficiency while maintaining manageable device complexity
Solution Approach 2:
A suction system with a suction source and suction openings is integrated into the blade head to create negative pressure that draws cut fibers away from the tissue surface. This hydraulic/pneumatic mechanism enables efficient fiber removal without requiring complex manual cleaning procedures
2Manufacturing precision
If fibers are not thoroughly removed from pericardial tissue, then the processing time is shorter, but the tissue quality and functionality for prosthetic heart valves are compromised
Solution Approach 1:
The suction system operates continuously during the fiber removal process, maintaining constant negative pressure to draw fibers away as they are cut. This continuous action ensures thorough fiber removal without requiring intermittent stopping or manual intervention, achieving high tissue quality without excessive processing time
Solution Approach 2:
The suction openings extract cut fibers from the tissue surface in real-time during the cutting process. By actively removing fibers as they are generated, the system prevents fiber accumulation and ensures complete fiber removal, maintaining high tissue quality while minimizing processing time
3Measurement precision
If a blade array is used to shear fibers, then fiber removal precision is improved, but the complexity of the blade assembly increases
Solution Approach 1:
Different portions of the blade head have different functions: some areas have cutting blades for precise fiber shearing, while other areas have suction openings for fiber removal. This local differentiation of function achieves precise fiber removal without requiring the entire assembly to be overly complex
Solution Approach 2:
The cutting function and suction function are merged into a single integrated blade head assembly. The cutting blades and suction openings work together in close proximity, combining precision cutting with immediate fiber removal in one unified device, thereby achieving high precision without proportionally increasing complexity
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 method effectively removes fibers from ex vivo pericardial tissue, enhancing its suitability for use in prosthetic heart valves by improving tissue quality and reducing post-processing requirements.
Implementation Method 1
movement of the blade array, with respect to the face, shears the fibers that protrude through the gaps into the blade head
Implementation Method 2
the apparatus is configured to generate, while the blade array is submerged in the liquid, a suction force that sucks the liquid into the blade head via the gaps, and discharges a refuse liquid through the exhaust hole
Data Source
AI summary
Embodiments of the present disclosure include a method for conditioning ex vivo pericardial tissue that has a parietal side and a fibrous side from which fibers extend. A blade assembly includes a blade head having a blade array and a face that defines gaps therein. The parietal side of the tissue is placed downward against a support plate, and a motor is operated to move the blade array with respect to the face. The face contacts the tissue such that the fibers protrude through the gaps and into the blade head. The blade array shears the fibers that protrude through the gaps into the blade head, yielding sheared fibers. Other embodiments are also described.


