Dynamic Adjustment Tool for Implantable Valve Alignment

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Solution Overview

Problem

Magnetically programmable CSF shunt valves are prone to unintentional adjustments due to misalignment of magnetic axes, leading to potential overdrainage or underdrainage, and existing tools are difficult to use for aligning these axes effectively.

Innovation Solution

A dynamic adjustment tool with a locator and an adjustor that allows for rotational, lateral, and orbital movement within the locator, enabling alignment of the magnetic axis with the rotor axis even when misaligned, and maintaining the rotor in an unlocked state for adjustment, while indicators on the tool help confirm the valve setting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a magnetic programmer is used to adjust the valve setting, then the valve can be programmed externally without invasive surgery, but the valve is prone to unintentional adjustments due to misalignment of magnetic axes

Engineering Contradiction:
Improveexternal adjustment capabilityVSAvoidunintentional adjustment risk
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs feedback mechanisms including visual indicators (aligned/misaligned markers), tactile feedback (clicks or resistance when axes align), and confirmation displays that show when the magnetic axis of the programmer aligns with the rotor axis of the valve. This feedback loop ensures the operator can verify proper alignment before making adjustments, preventing unintentional programming while maintaining ease of external adjustment.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent introduces an intermediary alignment mechanism between the magnetic programmer and the valve rotor. This includes alignment markers, guide structures, or intermediate components that mediate the interaction between the programmer's magnetic field and the valve's rotor, ensuring proper axial alignment is achieved and maintained during the programming process.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If existing alignment tools are used, then the valve can be adjusted, but it is difficult to align the magnetic axis with the rotor axis

Engineering Contradiction:
Improveadjustment capabilityVSAvoidalignment difficulty
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent utilizes color-coded indicators or visual markers that change appearance or provide contrast when the magnetic axis aligns with the rotor axis. For example, aligned markers may display matching colors or patterns, while misaligned markers show contrasting colors, making alignment visually intuitive and significantly easier for the operator.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent employs asymmetric alignment features such as non-circular markers, directional indicators, or asymmetric mechanical guides that provide inherent orientation cues. These asymmetric elements naturally guide the operator to the correct alignment position, reducing the difficulty of aligning the magnetic axis with the rotor axis while maintaining adjustment capability.

Inventive Principle:
Principle #4Asymmetry

3Reliability

If the magnetic axis is misaligned with the rotor axis, then the valve setting cannot be adjusted, but there is no way to determine if alignment has been achieved

Engineering Contradiction:
Improveadjustment accuracyVSAvoidalignment status information
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent provides comprehensive feedback information through visual indicators (aligned/misaligned markers), tactile feedback (clicks or resistance when axes align), and confirmation displays that clearly indicate whether the magnetic axis is aligned with the rotor axis. This eliminates the information loss by giving the operator real-time knowledge of alignment status.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent uses color-coded indicators that provide immediate visual information about alignment status. For example, green indicators may signify proper alignment while red indicators indicate misalignment, or the markers may visually merge or separate based on alignment, giving the operator clear information feedback without which adjustment accuracy cannot be ensured.

Inventive Principle:
Principle #32Color 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

The tool allows for consistent and reliable adjustment of CSF drainage flow and pressure settings, reducing the risk of unintentional changes and simplifying the alignment process, thereby improving the safety and efficacy of valve adjustments.

Implementation Method 1

The adjustor has at least one magnet having a magnetic axis. The magnet has a strong enough magnetic field to unlock the internal rotor of the valve.

Methodology Applied
Scientific EffectMagnetic field interaction: Magnetism

Data Source

PatentEP2777751B1Dynamic adjustment tool for programming an implantable valve
Publication Date: 2020.01.01 INTEGRA LIFESCI SWITZERLAND SARL
  • EP2777751B1 patent drawingFigure 1A~1C
  • EP2777751B1 patent drawingFigure 2A~2D
  • EP2777751B1 patent drawingFigure 3A~3B

AI summary

A tool includes a locator 200 having a center aligned with a rotor axis 106 when disposed over the valve 100. The locator is approximately perpendicular with the rotor axis. An adjustor 300 is disposed in the locator. The adjustor fits within the wall and has a magnet 304 having a magnetic axis to unlock the rotor. An adjustable outer wall has a first position dimension 312 permitting the adjustor to rotate about the center of the locator and aligning the magnetic axis with the center. The adjustable outer wall has a second position dimension 316 less than the first dimension and the first position dimension. The adjustor can move lateral, rotational, and orbital in the locator misaligning the magnetic axis with the center. Misaligning the magnetic and rotor axes unlocks the rotors and the magnet maintains the unlocked state even when the axes are misaligned.