Biologic Intraocular Stent Shaping for Aqueous Outflow

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Solution Overview

Problem

Current ab interno stenting devices for glaucoma treatment using non-biological hardware materials cause erosion, fibrosis, and ocular tissue damage such as endothelial cell loss.

Innovation Solution

A system for deploying a biologically-derived tissue implant using a delivery device with a nose cone assembly and cutting blades to form an elongated strip, which is then inserted into the eye through a minimal incision, providing a biocompatible aqueous outflow pathway.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If non-biological hardware materials are used for stenting devices, then structural strength and durability are improved, but tissue damage, erosion, and fibrosis increase

Engineering Contradiction:

Improvestructural strengthVSAvoidtissue damage

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from non-biological hardware to biologically-derived materials (such as collagen, elastin, or other natural tissue components). This parameter change maintains the structural functionality needed for stenting while eliminating the harmful tissue damage, erosion, and fibrosis associated with synthetic materials. The biological material is processed to maintain structural integrity while being compatible with ocular tissues.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention uses composite or processed biological materials that combine structural support properties with biocompatibility. The material may involve cross-linked or treated biological tissues that provide the necessary mechanical strength for the stent function while maintaining tissue compatibility, thereby resolving the contradiction between strength and tissue damage.

Inventive Principle:

Principle #40Composite materials

2Duration of action of stationary object

If non-biological hardware materials are used for stenting devices, then device durability is improved, but erosion and fibrosis increase

Engineering Contradiction:

Improvedevice durabilityVSAvoiderosion and fibrosis

Core Design Contradiction:

Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The patent changes the material composition parameter from synthetic hardware to biologically-derived materials. This parameter change allows the device to maintain durability through natural tissue regeneration and integration rather than long-term foreign body persistence, thereby reducing erosion and fibrosis while maintaining functional durability.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention may utilize biodegradable or temporarily implanted biological materials that perform their function and then naturally integrate or resorb. This approach accepts that the material will not permanently remain as foreign hardware but will instead be replaced by native tissue, eliminating the harmful effects of long-term foreign body presence.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Reliability

If biologically-derived tissue is used for implant, then biocompatibility and safety are improved, but manufacturing complexity increases

Engineering Contradiction:

ImprovebiocompatibilityVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs preliminary processing of biological materials through standardized protocols for harvesting, cleaning, cross-linking, and forming the stent structure. These preliminary actions are performed in controlled manufacturing environments before implantation, ensuring consistency and reliability while managing the complexity through established procedures rather than ad-hoc processing.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The invention may use intermediary processing steps such as cross-linking agents or scaffold structures that facilitate the transformation of raw biological material into the final stent product. These intermediaries simplify the manufacturing process by providing structured templates or chemical mediators that guide the formation of the stent while maintaining biocompatibility.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Stability of the object's composition

If minimal modification of biologically-derived tissue is performed, then tissue integrity is preserved, but implant shaping flexibility is reduced

Engineering Contradiction:

Improvetissue integrityVSAvoidimplant shaping flexibility

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent applies minimal modification techniques that preserve the overall tissue integrity and biological properties while making localized adjustments to achieve the required implant shape and size. Processing steps such as gentle cutting, folding, or localized cross-linking are applied only where necessary to conform to the stent geometry without compromising the fundamental tissue structure and biocompatibility.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS12453656B2System for shaping and implanting biologic intraocular stent for increased aqueous outflow and lowering of intraocular pressure

Publication Date: 2025.10.28 IANTREK INC

AI summary

A system for deploying an implant cut from a biological tissue into an eye of a patient including a delivery device and a nose cone assembly, a tubular shaft projecting from the distal end region of the nose cone and comprising a lumen. Related devices, systems, and methods are provided.