Microporous Elastomeric Implant for Drusen Reduction

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Solution Overview

Problem

Current treatments for age-related macular degeneration (AMD) and diabetic retinopathy, particularly the dry form, lack effective methods to prevent or reverse the progression of drusen formation and associated vision loss, with existing therapies focusing on slowing progression rather than restoration of vision or complete reversal.

Innovation Solution

Implantable microporous devices made of biocompatible elastomeric materials with optimized pore geometry to attract and concentrate macrophage cells, reducing drusen accumulation, inflammation, and promoting a pro-healing environment, which can be injected into the eye to prevent or reverse AMD and diabetic retinopathy progression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If repeated injections of anti-inflammatory drugs or anti-angiogenic therapies are administered, then progression of wet AMD or diabetic retinopathy is slowed, but vision loss cannot be restored and treatment compliance becomes difficult

Engineering Contradiction:
Improvedisease progression controlVSAvoidtreatment compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The microporous device is implanted in advance to create a sustained drug reservoir that continuously releases therapeutic agents over time, eliminating the need for repeated patient visits and injections. The device proactively maintains therapeutic drug levels in the target tissue without requiring ongoing patient compliance with injection schedules.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The microporous device acts as an intermediary carrier between the drug and target tissue, providing controlled release kinetics and maintaining consistent drug concentrations. This mediator function ensures reliable disease progression control while removing the burden of repeated patient self-administration or clinic visits.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If laser sealing of blood vessels is performed to treat diabetic retinopathy, then leaking vessels are sealed, but vision restoration is not achieved and repeated treatments are required

Engineering Contradiction:
Improveleakage controlVSAvoidmultiple treatment sessions
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The microporous device provides continuous release of therapeutic agents at the implantation site, maintaining sustained control of vascular leakage and inflammation. This continuous action replaces the need for multiple discrete laser treatment sessions, achieving prolonged therapeutic effect from a single implantation procedure.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The device changes the temporal parameter of drug delivery from acute, repeated interventions to sustained, continuous release. By controlling the release kinetics and maintaining therapeutic drug levels over extended periods, the device achieves reliable leakage control while reducing the frequency of treatment sessions.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If no treatment is given for dry AMD, then no harmful side effects occur, but drusen accumulation progresses and vision loss increases

Engineering Contradiction:
Improveside effectsVSAvoidvision preservation
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The microporous device is designed to be self-contained and self-regulating, using biocompatible materials and controlled release mechanisms that do not require external control or adjustment. The device autonomously maintains therapeutic drug levels and reduces drusen accumulation without causing harmful side effects, preserving vision through sustained local action.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The microporous structure of the device enables controlled release of therapeutic agents while allowing tissue integration and minimizing foreign body response. The porosity facilitates sustained drug delivery and interaction with surrounding tissue, achieving effective drusen reduction without the harmful side effects associated with systemic or aggressive local therapies.

Inventive Principle:
Principle #31Porous materials

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 microporous devices effectively reduce drusen formation, alleviate inflammation, and restore a healthy balance of growth factors, thereby preventing the progression of both dry and wet forms of AMD and diabetic retinopathy, offering a potential cure or significant slowing of disease progression.

Implementation Method 1

The devices are also capable of preventing progression of diabetic retinopathy... the microporous device... comprises a plurality of interconnected pores throughout the device body and extending to the outer surface... attract and concentrate macrophage cells

Methodology Applied
Scientific EffectMacrophage cell attraction and concentration:

Data Source

PatentEP3313466B1Injectable porous device for treatment of dry and wet age-related macular degeneration or diabetic retinopathy
Publication Date: 2024.08.07 HEALIONICS CORP
  • EP3313466B1 patent drawingFigure 1A~1B
  • EP3313466B1 patent drawingFigure 2
  • EP3313466B1 patent drawingFigure 3

AI summary

This disclosure provides a method for reducing or preventing the formation and/or accumulation of drusen in an eye of a mammalian subject in need thereof, the method comprising implanting one or more microporous devices into the eye using a needle having an interior dimeter of 0.2-0.3mm. Each device having a device body (10) and an outer surface (18), wherein the microporous device is formed of a biocompatible elastomeric material and comprises a plurality of interconnected pores (16,20) throughout the device body and extending to the outer surface, and wherein substantially all the interconnected pores in the microporous device are each interconnected to at least 2 other pores, a mean diameter of the pores being between about 5 and about 50 micrometers, and any two adjacent pores are connected by a throat (30), a mean throat diameter being at least 5 micrometers.