Glaucoma Implant Valve with Thermomechanical Flap

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Solution Overview

Problem

Current glaucoma drainage implants without valves risk postoperative hypotonia due to incomplete pressure closure, while implants with valves, like the Ahmed implant, show no significant long-term benefits over trabeculectomy, and are prone to fibrovascular encapsulation leading to clogging and increased intraocular pressure.

Innovation Solution

A glaucoma drainage implant with a pressure relief valve featuring a movably connected pressure relief flap, utilizing a thermomechanically active area, such as a shape-memory material, to non-invasively mobilize the flap and prevent fibrotic encapsulation, allowing for controlled drainage of aqueous humor.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a valve is added to prevent postoperative hypotonia, then pressure control is improved, but fibrovascular encapsulation and clogging occur

Engineering Contradiction:
Improvepressure controlVSAvoidfibrovascular encapsulation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pressure relief flap is designed to be movable rather than fixed, allowing it to dynamically respond to pressure changes. The flap can open when intraocular pressure exceeds a threshold and close when pressure is normalized, providing adaptive pressure control that reduces fibrotic response compared to fixed valves

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The flap's position and opening area are changed based on pressure parameters. When pressure increases, the flap opens to a degree proportional to the pressure excess, allowing controlled drainage that prevents both hypotonia and fibrotic encapsulation

Inventive Principle:
Principle #35Parameter changes

2Reliability

If cytotoxins are used to prevent fibrotic encapsulation, then drainage functionality is improved, but risk of sterile endophthalmitis increases

Engineering Contradiction:
Improvedrainage functionalityVSAvoidsterile endophthalmitis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces chemical prevention methods (cytotoxins) with a mechanical solution - a movable pressure relief flap that physically prevents fibrotic encapsulation through its movement mechanism, eliminating the need for cytotoxic agents and their associated risks

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If the pressure relief flap is made fixed to ensure closure, then pressure control is improved, but long-term functionality deteriorates due to encapsulation

Engineering Contradiction:
Improvepressure controlVSAvoidlong-term drainage functionality
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The pressure relief flap transitions from a fixed structure to a dynamic, movable component that can open and close based on pressure conditions, ensuring long-term functionality by preventing fibrotic encapsulation while maintaining pressure control

Inventive Principle:
Principle #15Dynamics

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 solution effectively reduces the risk of fibrotic encapsulation and hypotonia, maintaining long-term drainage functionality without the need for cytotoxins like mitomycin C, and allows for controlled regulation of intraocular pressure, enhancing the implant's long-term outcomes compared to prior art.

Implementation Method 1

the actuation area has a thermomechanically active area, which allows the pressure relief flap to be mobilized non-invasively by a change in temperature. The actuation area is preferably provided in the form of a shape-memory material or includes such a material.

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS10912675B2Glaucoma drainage implant
Publication Date: 2021.02.09 NIKOLIC MED STEPHAN DR
  • US10912675B2 patent drawing
  • US10912675B2 patent drawing
  • US10912675B2 patent drawing

AI summary

A glaucoma drainage implant comprising a pressure relief valve via which aqueous humor can be drained. The pressure relief valve has a pressure relief flap which is movably connected with a base plate of the implant, which is to be embedded in a sclera, wherein the pressure relief flap has an actuation area by means of which the pressure relief flap can be mobilized non-invasively during a post-operative healing phase or thereafter. The actuation area is preferably designed as a thermomechanically active area.