Cultured Cell Leaflet Material for Prosthetic Heart Valves
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Solution Overview
Problem
Existing heart valve prosthetics made from bovine or porcine pericardial tissue face challenges such as uneven mechanical properties, difficulty in ensuring disease-free tissue, and potential animal health issues, while attempts to grow heart valves from stem cells have been inadequate in replicating necessary mechanical and biological properties.
Innovation Solution
Prosthetic heart valves are created using cultured cell tissue sheets formed from fibroblast and smooth muscle cells, which are chemically cross-linked under tension to produce leaflets with consistent mechanical properties, such as specific thickness, elongation, and tensile strength, and integrated into a prosthetic heart valve system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If bovine or porcine pericardial tissue is used to make prosthetic heart valves, then biological tissue availability is improved, but mechanical property consistency deteriorates
Solution Approach 1:
The patent creates artificial copies of natural heart valve tissue by culturing fibroblast and smooth muscle cells to form tissue sheets that replicate the mechanical and biological properties of native pericardial tissue. This copying approach allows production of tissue with consistent, controllable properties while maintaining the benefits of biological material.
Solution Approach 2:
The patent controls and standardizes key parameters of the cultured tissue including thickness (50-300 micrometers), elongation percentages, and tensile strength (4-6.5 MPa) through regulated cell culture processes. This parameter control ensures mechanical property consistency while maintaining biological functionality.
2Reliability
If natural animal tissue is used for prosthetic valves, then biological functionality is improved, but disease transmission risk increases
Solution Approach 1:
The patent extracts only the essential biological components (fibroblast and smooth muscle cells) needed to create functional heart valve tissue, separating these from the animal organism. This allows production of biologically functional tissue without using complete animal organs, thereby eliminating disease transmission risks associated with natural tissue transplantation.
Solution Approach 2:
Instead of transplanting actual animal tissue, the patent creates cultured cell copies that replicate the desired biological functionality. These cultured tissues are grown in controlled laboratory conditions, ensuring they are free from animal-borne pathogens while maintaining the mechanical and biological properties needed for heart valve function.
3Adaptability or versatility
If stem cells are used to grow heart valve leaflets, then tissue regeneration capability is improved, but mechanical property adequacy deteriorates
Solution Approach 1:
The patent uses specific cell types (fibroblasts and smooth muscle cells) that are locally optimized for producing the mechanical properties needed in heart valve tissue. Rather than using undifferentiated stem cells with broad regeneration potential, the patent selects cells that naturally produce the required tensile strength, elasticity, and structural integrity for valve leaflets.
Solution Approach 2:
The patent performs preliminary cell culture and differentiation steps before forming the final tissue structure. Fibroblast and smooth muscle cells are cultured and allowed to develop appropriate mechanical properties before being assembled into leaflet structures, ensuring that the tissue achieves adequate strength and mechanical performance before implantation.
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 cultured cell tissue leaflets demonstrate uniform mechanical properties, providing a reliable and consistent material for prosthetic heart valves that can match the requirements for long-term in vivo use, overcoming the limitations of natural tissue-based prosthetics.
Implementation Method 1
chemically cross-linking the sheet of cultured cells while under tension to fix the sheet
Data Source
AI summary
A prosthetic heart valve provided herein can include a cultured cell tissue leaflet. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member. The cultured cell tissue can be obtained by culturing fibroblast cells, smooth muscle cells, or a combination thereof to form a sheet of cultured cells and chemically cross-linking the fibroblast cells while under tension. In some cases, the cultured cell tissue can be radially tensioned. In some cases, the cultured cell tissue can be bi-axially tensioned.