Biologic Luminal Graft for Small-Diameter Vessel Replacement
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Solution Overview
Problem
Conventional vascular grafts, particularly for small-diameter vessels, face issues such as high failure rates due to thrombosis, kinking, anastomotic hyperplasia, infection, biological failure, and compliance mismatch, leading to inadequate long-term patency and increased risks in hemodialysis and nerve regeneration applications.
Innovation Solution
A luminal graft composed of elastin and collagen fibers, with a dominant elastin component, utilizing pulmonary ligament tissue or visceral pleura, which is flexible and capable of arterialization, and features a unique closure mechanism to maintain patency and promote tissue integration, reducing the risk of thrombosis and scar tissue growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional synthetic materials (Dacron, polytetrafluoroethylene) are used for vascular grafts, then structural strength and durability are improved, but thrombogenicity and compliance mismatch with host vessels worsen
Solution Approach 1:
The patent changes the material parameters by using biologic tissue (pericardium, fascia, dermis) instead of synthetic materials, altering the surface properties and mechanical characteristics to reduce thrombogenicity while maintaining structural integrity through natural tissue composition
Solution Approach 2:
The patent employs composite construction by combining biologic tissue layers with specific architectural arrangements, creating a graft that integrates both structural support and biocompatible surface properties to address both strength and thrombogenicity requirements
2Manufacturing precision
If conventional synthetic materials are used for small-diameter vascular grafts, then manufacturing precision is improved, but long-term patency worsens due to intimal hyperplasia and thrombosis
Solution Approach 1:
The patent changes the biological parameters of the graft material by using decellularized biologic tissue, which alters the cellular interaction properties and reduces the host's thrombotic and hyperplastic responses while maintaining the engineered dimensional precision
Solution Approach 2:
The patent uses an intermediary approach by applying anticoagulant and anti-proliferative coatings or treatments to the biologic tissue surface, creating a protective interface that prevents thrombosis and intimal hyperplasia while allowing the precisely manufactured graft structure to function
3Object-affected harmful factors
If autologous blood vessels are used for grafting, then biocompatibility is improved, but surgical complexity and patient morbidity worsen due to requiring a second surgical site
Solution Approach 1:
The patent extracts the beneficial biological properties (biocompatibility, anti-thrombogenic surface) from autologous tissue by using decellularized biologic material, allowing these properties to be achieved without requiring harvesting from a second surgical site, thereby simplifying the surgical procedure
4Strength
If conventional vascular grafts are used, then initial structural integrity is improved, but long-term functional performance worsens due to aneurysm formation and compliance mismatch
Solution Approach 1:
The patent changes the mechanical parameters of the graft by using biologic tissue with natural elastic and compliant properties, allowing the graft to better match the host vessel's mechanical behavior over time, thereby preventing aneurysm formation and maintaining long-term functional performance
Solution Approach 2:
The patent applies dynamics by using biologic tissue that can adapt and remodel over time, allowing the graft's mechanical properties to evolve and match the host vessel dynamically, preventing compliance mismatch and aneurysm formation in the long term
Data Source
AI summary
The disclosure of the present application provides devices, systems, and methods for replacing damaged or compromised blood vessels and engineering luminal grafts for various medical applications. Such devices are capable of providing viable, small-diameter grafts for use in anastomotic procedures and comprise a tubular construct consisting largely of elastin and some collagen fibers and having at least one diameter of less than or equal to about 5 mm. In one exemplary embodiment, the graft comprises at least one layer of pulmonary ligament tissue and/or pulmonary visceral pleura. Systems and methods for the manufacture of the graft are also provided, which include the use of at least one layer of tissue, a mandrel and a closure mechanism.