M.blue®

The balanced way

of life.

Inspired by you.

FEATURES

  • ONE valve for the unique 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
  • Protected 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
  • Protected against unintentional adjustment by means of exposure to magnets found in daily life, such as those used in smartphones, toys, induction cookers 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

24/7 - One valve for all requirements

individual and flexible

Hydrocephalus has many causes and a myraid of manifestations. Moreover, every person is unique. On average, our day is divided into 8 hours of sleep and 16 hours of active daily activities. While the resting phases hardly differ from person to person, there are wide differences in activity from person to person and from patient to patient in everyday life. This is why it is so crucial for optimal, individual treatment 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 that meets the most diverse forms of hydrocephalus with a particularly high degree of flexibility in therapy.

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.

The M.blue is a position-dependent hydrocephalus valve. 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 over-drainage complications, especially in the upright and active body position.

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 over-drainage 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 as needed 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 maintaining 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 active 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.

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 identified, adjusted 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 can be 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, open-up the compass without altering its position.

Weiterlesen

The M.blue plusadjustment 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 2.0 scale. 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.

The unique "Active-Lock" mechanism protects the M.blue against unwanted adjustment due to the influence of external magnetic fields and makes the M.blue compatible for MRI examinations up to 3 Tesla. This eliminates the need for X-ray control after MRI imaging and protects the patient from additional radiation exposure. Only an active pressure on the valve diaphragm releases the rotor brake and makes an adjustment possible. Thanks to the built-in tactile feedback mechanism, this can usually be felt and heard by a click, thus giving the doctor the necessary feedback and assurance that the applied pressure is sufficient for an adjustment. As long as pressure is not applied directly to the valve diaphragm, it remains safe from unintentional adjustment.

Learn more about our M.blue adjustment tools:
M.blue adjustment tools

 

PRESSURE LEVEL DETECTION IN X-RAY IMAGE

The set pressure level of the M.blue can be reliably checked at any time with the M.blue plus compass without need for additional X-ray examination.
For recognition in the X-ray image, we recommend the use of the MIETHKE App. Here, the valve can be individually adjusted according to the X-ray image and the pressure level of the M.blue can be reliably read by means of a template (picture on the right: 5cmH2O).
The selection of the appropriate pressure level of the M.blue depends on several factors, including the patient's age, degree of activity, height and stature. For further information, please refer to our recommended pressure level.

 

MIETHKE APP - UNDERSTANDING VALVES EASILY


The MIETHKE App shows clearly and quickly understandable how our valves work:

+ Influence of the body position on the opening pressure: The motion sensor of the smartphone simulates the body position of the patient: upright - inclined - lying.

+ Pressure stage recognition in the X-ray image: Every set or preset pressure stage is shown here and can be easily recognized by means of templates.

+ Simulation of adjustability: Valves can be easily adjusted with the finger and thus help to understand what is happening inside the valve.

+ View into the inside of MIETHKE valves: All valves allow a view of their construction and thus the influence of the cerebrospinal fluid flow on the functioning can be shown in an easily understandable way.

+ free for Apple and Android
 

   

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

GBA_12_01_0620_WEB.pdf

M.blue plus Instructions for use

GBA_13_01_0620_WEB.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.

Thoralf Knitter

Head of Research & Development

Roland Schulz

Head of Product Management

Thammo Weise

Product Management

Andreas Bunge

Product Management

Michaela Funk-Neubarth

Head of Marketing & HR

Jan Mügel

Product Management

Josefine Kehl

Deputy Head of Marketing & Corporate Communications

August von Hardenberg

Product Management

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OUR PARTNERSHIP
WITH B. BRAUN

B. Braun and MIETHKE - Together for a better life with hydrocephalus

We have a long and intensive partnership with B. Braun in the field of neurosurgery. We are driven by a common vision: to improve the lives of hydrocephalus patients around the world with innovative solutions.

Our partnership is an exciting combination of B. Braun's nearly 180 years of expertise as one of the world's leading medical device and pharmaceutical companies and our agility as an innovative company and technology leader in gravitation-based shunt technology.

 

Our strong partner in neurosurgery:

www.bbraun.com