Adjustable Glaucoma Shunt Gating for Remote Outflow Resistance Control

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Solution Overview

Problem

Current glaucoma treatments require frequent and invasive procedures to adjust the outflow resistance of implanted shunts, which can lead to complications such as hypotony and increased costs, as they do not allow for non-invasive, remote adjustment of fluid flow post-implantation.

Innovation Solution

The development of adjustable flow glaucoma shunts with a flow control assembly that includes an anchoring element, actuation elements, and a gating element, allowing for selective adjustment of fluid flow through the shunt using energy, enabling incremental or continuous change in flow resistance without additional invasive surgeries.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If traditional glaucoma shunts are used, then the shunt provides basic fluid drainage function, but frequent invasive procedures are required to adjust outflow resistance

Engineering Contradiction:
Improveadjustment of outflow resistanceVSAvoidshunt structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The shunt incorporates a flow control assembly with a movable gating element that can dynamically adjust the outflow resistance. The gate transitions between different positions (first, second, and intermediate positions) to modulate fluid flow, transforming a static shunt into a dynamically adjustable device that responds to actuation signals.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent introduces a flow control assembly as an intermediary mechanism between the shunt lumen and the external environment. This assembly includes actuation elements and gating elements that mediate the adjustment of fluid flow, allowing remote modification of outflow resistance without direct surgical intervention.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If invasive procedures are performed frequently to adjust shunt flow, then outflow resistance can be modified, but complications such as hypotony increase and costs increase

Engineering Contradiction:
Improveoutflow resistance controlVSAvoidhypotony and complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The flow control assembly incorporates sensors that detect fluid flow characteristics and intraocular pressure, providing feedback about the shunt's performance. This feedback mechanism enables closed-loop control where the system can automatically adjust the gate position to maintain optimal outflow resistance, preventing complications like hypotony through real-time monitoring and adjustment.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The shunt system is designed to self-regulate fluid flow through automated control mechanisms. The actuation elements respond to sensor feedback without requiring external manual intervention, allowing the device to service itself by automatically adjusting outflow resistance to prevent complications.

Inventive Principle:
Principle #25Self-service

3Ease of manufacture

If a simple shunt structure is used, then manufacturing is easier, but non-invasive remote adjustment capability is not available

Engineering Contradiction:
Improveshunt fabricationVSAvoidpost-implantation adjustment capability
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The shunt is divided into distinct functional segments: a simple lumen for fluid drainage, a flow control assembly with gating elements for flow regulation, and actuation elements for remote control. This segmentation allows the basic shunt structure to remain simple and easy to manufacture, while the modular flow control assembly provides advanced adaptability and remote adjustment capabilities.

Inventive Principle:
Principle #1Segmentation

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 precise regulation of intraocular pressure and fluid flow, reducing the need for repeated invasive procedures, thereby minimizing complications and costs, and allowing for long-term effective operation of the shunt post-implantation.

Implementation Method 1

The actuation element is composed of a shape memory material and is configured to transition the gating element from the first position to and/or toward the second position

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS11517477B2Adjustable flow glaucoma shunts and associated systems and methods
Publication Date: 2022.12.06 SHIFAMED HLDG LLC
  • US11517477B2 patent drawing
  • US11517477B2 patent drawing
  • US11517477B2 patent drawing

AI summary

The present technology is directed to adjustable flow glaucoma shunts and methods for making and using such devices. In many of the embodiments described herein, the shunts include a generally flat frame. The frame can include an elongated portion having a lumen extending therethrough and a bladder portion defining an interior chamber that is in fluid communication with the lumen. When implanted in a patient's eye, aqueous can drain from the anterior chamber to a target outflow location via the lumen and interior chamber. In some embodiments, the shunts include a flow control assembly positioned within the interior chamber of the bladder portion to control the flow of aqueous through the lumen.