Cutting and Delivery of Biologic Intraocular Implants for Aqueous Outflow
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Solution Overview
Problem
Current ab interno stenting devices for glaucoma treatment using non-biological hardware materials face issues such as erosion and fibrosis, leading to ocular tissue damage and endothelial cell loss.
Innovation Solution
Development of biologically-derived tissue-based implants, such as amniotic membrane and scleral tissue, which are cut into elongate shapes and delivered using a trephining system to create a pathway for aqueous outflow, with minimal manipulation to maintain biological characteristics and therapeutic factors for improved tolerability and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If non-biological hardware materials are used for ab interno stenting devices, then structural strength and durability are improved, but tissue erosion, fibrosis, and ocular damage occur
Solution Approach 1:
The patent changes the material parameter from non-biological hardware to biologically-derived tissue materials. The biostent is made from decellularized extracellular matrix that maintains structural integrity while being biocompatible, resolving the contradiction between strength and tissue compatibility
Solution Approach 2:
The patent uses composite material construction where the biostent combines decellularized extracellular matrix with preserved growth factors and inflammatory mediators. This composite approach provides both structural support and therapeutic benefits, eliminating tissue erosion and fibrosis associated with traditional hardware materials
2Object-affected harmful factors
If biologically-derived tissue materials are used for implants, then tissue compatibility and healing are improved, but structural strength may be reduced
Solution Approach 1:
The patent applies parameter changes by controlling the decellularization process to preserve the mechanical properties of the extracellular matrix while removing immunogenic cells. The resulting biostent maintains adequate structural strength for stenting while being fully biocompatible
Solution Approach 2:
The biostent functions as a composite material system where the decellularized matrix provides structural framework and the preserved biological factors provide therapeutic enhancement. This composite structure achieves both tissue compatibility and sufficient structural strength
3Ease of operation
If extensive manipulation is performed on biological tissue to form implants, then implantability and delivery are improved, but biological characteristics and therapeutic factors are lost
Solution Approach 1:
The patent applies preliminary action by pre-decellularizing the tissue and preserving growth factors during manufacturing, then storing the biostent in a stable form. During surgery, the implant is simply delivered and deployed with minimal additional manipulation, preserving both implantability and biological characteristics
Solution Approach 2:
The patent controls physical-chemical parameters during processing to maintain biological integrity. The decellularization and preservation processes are optimized to retain growth factors and inflammatory mediators while enabling safe storage and delivery of the implant
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 biologically-derived implants provide enhanced aqueous outflow with reduced tissue damage and improved safety by using minimally modified biological materials that elute healing factors, creating a scaffold for augmented drainage.
Implementation Method 1
The bio-tissue material includes amniotic membrane tissue configured to elute one or more healing factors derived from the amniotic membrane tissue
Implementation Method 2
The vacuum source can be configured to aspirate the implant into the distal opening of the delivery cannula when the vacuum source is coupled to the cartridge and activated
Data Source
AI summary
A system for treating an eye comprising a tissue stored within a lumen of an elongated cannula, the tissue comprises scleral, amniotic membrane, or acellular biomatrix tissue and having an elongated form factor. Related devices, systems, and methods are provided.