Implanted Valve Toolset for Non-Invasive Adjustment

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Solution Overview

Problem

Current medical devices, such as adjustable shunt valves for hydrocephalus treatment, face challenges in resisting unintentional setting changes due to vibrations, jarring, or unintended magnetic fields, and lack accurate and simplified methods for non-invasive location, orientation, and adjustment.

Innovation Solution

A toolset comprising a positioning tool, an indicator tool, and an adjustment tool is developed to accurately locate and adjust implanted magnetically adjustable devices, using marking guides and sensor arrays to detect the actual valve setting and resist unintended changes, ensuring precise alignment and operation under strong magnetic fields.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If adjustable valves use applied magnetic fields for non-invasive adjustment, then ease of operation is improved, but reliability deteriorates due to unintentional setting changes from vibrations, jarring, or unintended magnetic fields

Engineering Contradiction:
Improvenon-invasive adjustmentVSAvoidresistance to unintentional setting changes
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The valve mechanism is pre-configured with a specific rotor design featuring arcuate cam surfaces and a ratchet-like engagement system that inherently prevents backward rotation. This preliminary structural arrangement ensures that once a setting is achieved through magnetic field application, the valve cannot accidentally revert to a previous setting due to vibrations or unintended magnetic fields.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The cam follower acts as an intermediary mechanical element between the rotor and the valve member. It translates the rotor's rotational position into precise valve opening pressure settings while the ratchet mechanism on the cam follower prevents reverse motion, thereby mediating between the magnetic field actuation and the final valve setting to ensure reliability.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If MRI machines use strong magnetic fields for imaging, then measurement precision is improved, but object-affected harmful factors worsen due to potential interference with implanted devices

Engineering Contradiction:
Improveimaging qualityVSAvoidinterference with implanted devices
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The valve's rotor is equipped with magnets that are specifically designed to be responsive to the MRI machine's magnetic field. While the MRI field was originally a potential harmful factor, the invention converts it into a beneficial tool for non-invasive detection and adjustment of the valve setting. The magnets in the rotor allow the MRI field to accurately determine the valve's current setting without causing unintended changes.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The valve mechanism uses discrete cam surfaces with specific geometric parameters that correspond to different valve opening pressures. By changing the rotor's angular position in discrete increments, each aligning with a specific cam surface, the valve setting is adjusted in predetermined steps. This parameter-based approach ensures that only specific, intended settings can be achieved, preventing continuous or accidental adjustments during MRI exposure.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If toolsets use magnetic field detection for locating and adjusting valves, then ease of operation is improved, but device complexity increases

Engineering Contradiction:
Improvelocation and adjustmentVSAvoidtoolset structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The toolset is designed with multi-functional components. The same tool that applies magnetic fields for adjustment also detects the valve's current setting through magnetic field interaction with the rotor magnets. Additionally, the toolset can locate the implanted valve by detecting the magnetic signature of the rotor. This universal design allows a single tool to perform multiple functions (location, detection, and adjustment), reducing the need for separate specialized devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 toolset enables reliable and precise non-invasive adjustment of implanted valve settings, minimizing unintended changes and improving detection accuracy, even under MRI exposure up to 3.0 Tesla, thus enhancing the stability and effectiveness of hydrocephalus treatment.

Implementation Method 1

The rotor has a rotor magnet that responds to an applied magnetic field by rotating to one of a plurality of angular positions

Methodology Applied
Scientific EffectMagnetic field interaction: Magnetic Field

Implementation Method 2

A magnet is carried by an indicator wheel assembly to detect an actual setting of the implanted valve unit

Methodology Applied
Scientific EffectMagnetic attraction: Magnetism

Data Source

PatentEP2826517B1Method and tools for implanted device
Publication Date: 2019.10.02 INTEGRA LIFESCI SWITZERLAND SARL
  • EP2826517B1 patent drawingFigure 1~2
  • EP2826517B1 patent drawingFigure 1A~4
  • EP2826517B1 patent drawingFigure 5~6A

AI summary

A method and toolset (1060, 1070) capable of remotely moving a rotor of an implanted device in a first arcuate direction and detecting a first limit of travel, moving the rotor in a second, opposite direction and detecting a second limit of travel without altering the current performance setting of the implanted device, comparing the first and second limits of travel with known values for a plurality of selectable performance settings, and indicating the current performance setting of the implanted device.