M.blue®

The balanced way of life.

Inspired by you.

FEATURES

  • ONE valve for the special requirements of a life with hydrocephalus: mobility, growth, changes in the course of disease
  • Unique uncompromising pressure adaption to optimize individual patient needs
  • Smallest adjustable gravitational valve worldwide
  • 2 in 1 technology: adjustable gravitational unit combined with fixed differential pressure unit in one valve
  • Efficient protection against over drainage through individually and continuously adjustable opening pressure from 0-40 cmH2O
  • MRI-compatible up to 3 Tesla - no X-ray control after MRI necessary, no additional radiation exposure for the patient
  • Safe from unintentional adjustment by magnets of daily life as smartphone, toy, induction cooker or safety barriers at the airport
  • Innovative M.blue plus® Instruments for M.blue® and proGAV® 2.0
  • Intuitive, safe and comfortable adjustment
  • Precise precision engineering
  • Robust and durable: made of titanium

FUNCTIONALITY

The M.blue® is the essence of 26 years of experience with hydrocephalus and valve technology and the feedback of numerous doctors and patients worldwide.

Hydrocephalus has many causes and most diverse forms. Beyond that, every person is very individual. On average, our day is divided into 8 hours of sleep and 16 hours of day-time activities. While the resting phases hardly differ from each other, there are big differences in the daily activities from person to person and from patient to patient. For an optimal and individual treatment, it is crucial to focus on the flexible adjustability for the active time of the day, i.e. the upright body position, when developing a hydrocephalus valve. The M.blue® is a valve for various forms of hydrocephalus with a particularly high flexibility in therapy.

The M.blue® is a hydrocephalus valve operating in a position-dependent manner. It consists of an adjustable gravitational unit and a fixed differential pressure unit.

The combination of these two units ensures automatic adjustment of the opening pressure depending on the patient's body position and thus counteracts the risk of possible overdrainage complications, especially in the upright and active body position.

Particularly challenging and difficult forms of hydrocephalus require a much greater flexibility in treatment. This is what the M.blue plus® stands for: a combination of an adjustable gravitational unit and an adjustable differential pressure unit (proGAV® 2.0).

Both M.blue® variants are made of robust and biocompatible titanium and are the result of precise precision engineering.

The differential pressure unit in the M.blue® is available in the units 0, 5, 10 and 15 cmH2O. The selected opening pressure of the differential pressure unit is equally effective in all body positions. When lying down, the differential pressure unit acts alone and usually has a low selected opening pressure, so that the valve drains brain water in time when the brain pressure increases during sleep and rest phases. A microspiral spring that presses a sapphire ball into a ball seat is responsible for the correct pressure. If the brain pressure rises above the selected opening pressure, the spring gives way, the differential pressure valve opens and allows brain fluid to pass through until the brain pressure has dropped again accordingly.

The gravitational unit in the M.blue® is adjustable from 0-40 cmH2O and is only effective in the upright body position. Now the sum of both units - gravitational and differential pressure unit - determines the total opening pressure of the M.blue®. The more upright the patient is, the higher the opening pressure of the M.blue®. The considerably higher opening pressure in the active phases of the day is particularly important because hydrostatic and hydrodynamic phenomena in the shunt system take effect in the upright body position and there is otherwise a risk of overdrainage.

The opening pressure of the gravitational unit is determined by a combination of rotor, rod spring, tantalum weight and sapphire ball. The tantalum weight holds a sapphire ball in the ball seat via a lever, which closes or opens the valve. Depending on the body position of the patient, the influence of a tantalum weight on a sapphire ball changes and thus the valve opening pressure. The preload of the rod spring connected to the lever can be adjusted via a rotor using the M.blue plus® Instruments and can influence the desired opening pressure.

In the freely available MIETHKE App, the functionality of the adjustment and the position-dependent opening pressures are shown very clearly (for Android, for iOS).

More information about the different pressure levels and their X-ray detection can be found in the download area below.

VALVE ADJUSTMENT

With the M.blue plus® Instruments the opening pressure of the adjustable gravitational unit (0-40 cmH2O) of the M.blue® as well as the opening pressure of the adjustable differential pressure unit (proGAV® 2.0) of the M.blue plus® can be determined, changed and controlled. The instruments offer safe and easy usage for the physician and a comfortable adjustment for the patient.

1. Localize

It is recommended to first feel the valve and locate the inlet and outlet with your fingers.

Weiterlesen

Then place the open M.blue plus® compass on the valve so that the direction of flow is correctly aligned with the arrow markings on the compass. Now the compass is closed and fine-tuned by very light movements of the instrument. If the float in the center of the compass is centrally aligned within the mark, the instrument is in the correct position for all further steps.

2. Check

Once the float is centered, the currently set opening pressure can be read out from the line mark on the float.

Weiterlesen

Simply follow the line mark up to one of the two scales: For the opening pressure of the adjustable differential pressure unit (proGAV® 2.0), the setting range of 0-20 cmH2O on the outer scale applies, which is highlighted in light grey. For the opening pressure of the gravitational unit of the M.blue® the blue marked setting range of 0-40 cmH2O of the inner scale applies.

3. Adjust

To adjust the opening pressure, the compass is opened without leaving its position.

Weiterlesen

The M.blue plus® adjustment ring can now be inserted into the resulting opening in the middle. The marking on the adjustment ring should point to the desired opening pressure of the corresponding M.blue® or proGAV® 2.0scale. By applying light pressure with the index finger on the valve diaphragm which is located under the skin in the middle of the adjustment ring, the rotor brake is released and the opening pressure of the valve is changed to the desired value.

When adjusting the differential pressure unit of the proGAV® 2.0, make sure that the opening pressure is changed by a maximum of 8 cmH2O per adjustment process or by a maximum of 16 cmH2O per adjustment process when adjusting the gravitational unit of the M.blue®, otherwise errors may occur. After each adjustment, the set pressure level should be checked as described in steps 1 and 2.

M.blue®

Download information

GBA_11_01_0718_FG_WEB.pdf

M.blue® Instructions for use

GBA_11_01_1118_O_WEB.pdf

M.blue® Instructions for use

GBA_12_01_0718_FG_WEB.pdf

M.blue plus® Instructions for use

GBA_13_01_2018-10-18_FG.pdf

M.blue plus® Instruments Instructions for use

PHB_11_01_0718_FG_WEB.pdf

Patient Manual

DO YOU HAVE ANY QUESTIONS ABOUT THE PRODUCT?
WE ARE THERE FOR YOU.

Jan Mügel

Product Management

Michaela Funk-Neubarth

Head of Marketing & PR

Thoralf Knitter

Head of Research & Development

Christoph Miethke

CEO

Roland Schulz

Head of Product Management

Thammo Weise

Product Management

Andreas Bunge

Product Management

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OUR PARTNERSHIP WITH B. BRAUN

B. Braun and MIETHKE are connected by a long and intensive partnership, that started rather accidental.

In the early 90´s, the young engineer Christoph Miethke had first significant, scientific and economic successes with the idea to rely on gravitational technology for the treatment of hydrocephalus. At the same time, B. Braun was looking for an innovative partner for hydrocephalus shunts. Both had already heard of each other, but then met by chance in a clinic and neither of them was prepared for the moment that provided the foundation for this cooperation. It just fitted. In terms of time and a common understanding of values and partnership. Despite the differences in size.

Since 2010 B. Braun is no longer just a sales partner but also a minority shareholder in Christoph Miethke's company.

B. Braun and MIETHKE still share a common vision: to develop and offer technologies for a normal life for all hydrocephalus patients worldwide.

This common vision was and is particularly noticeable in the cooperation in the M.blue® project. Michaela Funk-Neubarth, Jan Mügel, Peter Ecker and Josefine Kehl (from left to right) formed a cross-company M.blue® team and pulled together for the market launch.

Our strong partner in neurosurgery:

www.bbraun.com