Implantable Mechanical Valve for Hydrocephalus Pulsatility

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Solution Overview

Problem

Current treatments for hydrocephalus, primarily relying on CSF shunts, inadequately address the pathogenetic alterations associated with intraventricular pulsatility and asymmetric brain parenchyma responses, leading to incomplete and indirect solutions.

Innovation Solution

A purely mechanical implantable device featuring a passive mechanical valve with a non-linear spring, which attenuates intraventricular pulsation by aspirating cerebrospinal fluid during systole and infusing it during diastole, thereby reducing intracranial pressure fluctuations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a passive mechanical valve with non-linear spring is used to attenuate intraventricular pulsation, then intraventricular pulsatility is reduced and intracranial pressure fluctuations are dampened, but the device requires precise mechanical design and calibration to match physiological pressure variations

Engineering Contradiction:
Improveintraventricular pulsatility reductionVSAvoidmechanical valve design complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs a non-linear spring mechanism that changes its mechanical parameters (stiffness, force characteristics) based on compression depth, allowing the valve to adaptively respond to varying intracranial pressure levels. This enables reliable pulsatility attenuation across different physiological conditions without requiring complex electronic control systems.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The passive mechanical valve operates autonomously using the intrinsic pressure variations of the cerebrospinal fluid itself to drive the non-linear spring mechanism. The system self-regulates intracranial pressure fluctuations without requiring external power sources, control electronics, or complex actuation systems, thereby reducing device complexity while maintaining reliability.

Inventive Principle:
Principle #25Self-service

2Reliability

If CSF shunts are used to treat hydrocephalus, then cerebrospinal fluid drainage is achieved, but the treatment does not adequately address intraventricular pulsatility and pathogenetic alterations

Engineering Contradiction:
Improvehydrocephalus treatment effectivenessVSAvoidresponse to pathogenetic alterations
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent transitions from static CSF shunt systems to a dynamic passive mechanical valve that actively responds to intracranial pressure pulsations. The non-linear spring mechanism dynamically adjusts to varying pressure conditions throughout the cardiac cycle, enabling the device to address both drainage needs and pulsatility-related pathogenetic alterations, thereby improving treatment effectiveness and adaptability.

Inventive Principle:
Principle #15Dynamics

3Ease of operation

If electric or electronic components are used in implantable hydrocephalus devices, then control and regulation capabilities are enhanced, but device complexity and potential failure points increase

Engineering Contradiction:
Improvepressure regulation controlVSAvoidelectric and electronic components
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent replaces electric and electronic control systems with a purely passive mechanical valve mechanism. The non-linear spring-based valve uses mechanical principles to automatically regulate intracranial pressure pulsations, eliminating the need for batteries, sensors, motors, or electronic circuitry. This substitution maintains adequate pressure regulation control while dramatically reducing device complexity and potential failure points.

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

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 device effectively reduces intraventricular pulsatility, maintaining average intracranial pressure while dampening pulsation-induced fluctuations, providing a mechanical solution without the need for electric or electronic components.

Implementation Method 1

a non-linear spring (17), exhibited a special non-linear characteristic... associated with and suitable for co-operating with the piston (13) to control it and hold it in position

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the piston (13) being subject to the intracranial pressure (ICP) present in said ventricle (VEN)

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentEP2851103B1Implantable mechanical valve device for the treatment of hydrocephalus syndrome
Publication Date: 2020.01.08 SIAD HEALTHCARE
  • EP2851103B1 patent drawingFigure 1~2
  • EP2851103B1 patent drawingFigure 3A~3D
  • EP2851103B1 patent drawingFigure 3E~3G

AI summary

An implantable device (10) for the treatment of hydrocephalus, having a mechanical passive valve device or assembly (VAL) comprising a cylindrical body (CIL, 12); a piston (PIS, 13), housed slidingly (f1) in the cylindrical body (CIL); and a spring (MOL-NL, 17), having non-linear characteristic for applying a force on the piston (PIS) such that, when the overall pressure of the cerebrospinal fluid (CSF) exceeds, during the phase of cardiac systole, a certain value, a rapid displacement of the piston (PIS, 13) in the cylindrical body in one direction (f2) takes place and, when the pressure of the CSF falls below a certain value, during the phase of cardiac diastole, the piston (PIS), under the control of the non-linear spring (MOL-NL), reacts and moves rapidly in a direction opposite (f3) to the first, so as to feed once again into the ventricle (VEN) the CSF previously aspirated.