Adjustable Glaucoma Shunt Flow Control for Noninvasive Pressure Titration

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Solution Overview

Problem

Existing glaucoma treatments require invasive surgical procedures to adjust fluid flow resistance in shunts, which can be costly, time-consuming, and risky, potentially leading to complications such as hypotony.

Innovation Solution

Implantable devices with adjustable flow control assemblies that can be remotely actuated using energy, allowing incremental adjustments of fluid flow resistance without additional surgeries, utilizing shape memory materials and ratchet mechanisms for precise regulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If invasive surgical procedures are used to adjust fluid flow resistance in shunts, then the initial implantation can be performed, but additional surgeries are required for adjustment which increases risk, cost, and time

Engineering Contradiction:
Improveadjustment of fluid flow resistanceVSAvoidsurgical procedure requirements
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent replaces mechanical surgical adjustment with a non-invasive energy-based actuation system. Shape memory materials (SMM) are used to create actuation elements that change their mechanical properties in response to applied energy (such as heat), enabling remote adjustment of the flow control element's position without requiring surgical intervention

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

Solution Approach 2:

The patent introduces an intermediary energy field (thermal or electromagnetic) as a mediator between the external control system and the internal flow resistance mechanism. This energy intermediary triggers the shape memory material to change shape, which in turn adjusts the flow control element, eliminating the need for direct mechanical surgical manipulation

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the shunt allows high fluid flow to reduce intraocular pressure, then glaucoma treatment is effective, but the risk of hypotony and other complications increases

Engineering Contradiction:
Improvetreatment efficacyVSAvoidhypotony and complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a dynamic flow resistance adjustment mechanism where the flow control element can be repositioned to change the lumen's flow resistance characteristics. This allows the system to adapt fluid flow levels dynamically based on treatment response, preventing both excessive pressure and hypotony by adjusting resistance in response to changing ocular conditions

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent incorporates a feedback mechanism where clinicians monitor intraocular pressure and treatment response, then use energy actuation to adjust the flow control element's position accordingly. This closed-loop control allows optimization of fluid flow to maintain safe pressure levels while preventing complications from excessive drainage

Inventive Principle:
Principle #23Feedback

3Adaptability or versatility

If the shunt structure is made adjustable with moveable elements, then long-term management flexibility is improved, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:
Improvelong-term management flexibilityVSAvoiddevice manufacturing
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The patent employs a nested structure where the flow control element is positioned within the lumen, and shape memory material actuation elements are integrated within or adjacent to the flow control mechanism. This nested arrangement allows multiple functional components to be compactly integrated without proportionally increasing device complexity or manufacturing difficulty

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent utilizes parameter changes in the shape memory material's physical state (such as phase transitions between martensite and austenite phases) to achieve large mechanical displacements from small energy inputs. This allows the adjustable mechanism to achieve significant functional range while maintaining a compact structure that is relatively straightforward to manufacture

Inventive Principle:
Principle #35Parameter changes

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

Enables non-invasive, long-term management of intraocular pressure by allowing clinicians to adjust fluid flow in response to patient needs, reducing complications and improving treatment efficacy.

Implementation Method 1

utilizing shape memory materials and ratchet mechanisms for precise regulation

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

ratchet mechanisms for precise regulation

Methodology Applied
Scientific EffectRatchet mechanism: Ratchet

Data Source

PatentEP4135640B1Adjustable glaucoma treatment devices and associated systems
Publication Date: 2025.12.24 SHIFAMED HLDG LLC
  • EP4135640B1 patent drawingFigure 1A~1B
  • EP4135640B1 patent drawingFigure 2
  • EP4135640B1 patent drawingFigure 3a

AI summary

The present technology is directed to implantable medical devices for draining fluid from a first body region to a second body region. Some embodiments of the present technology provide adjustable devices that are selectively titratable to provide various levels of therapy. For example, the adjustable devices can have a drainage element with a lumen extending therethrough, a flow control element, and an actuation assembly. The actuation assembly can drive movement of the flow control element to change a dimension of and/or a flow resistance through the lumen, thereby increasing or decreasing the relative drainage rate of aqueous from an eye. In some embodiments, the actuation assembly and the flow control element together operate as a ratchet mechanism that can selectively move the flow control element between a plurality of positions and lock the device in a desired configuration until further actuation of the actuation assembly.