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Active Implantable Systems

Our Active Implantable system solutions - based on the Brain Interchange Technology

We provide fully developed active implantable systems that you can integrate directly into your therapeutic concepts. The Brain Interchange platform enables customers to bring implantable solutions to market faster, with significantly reduced technical and regulatory risk.

Built on our proprietary implantable electronics, hermetic packaging, and wireless communication technologies, our systems offer a robust foundation for therapies requiring chronic sensing, stimulation, or closed‑loop interaction with neural and physiological structures.

Implantable Unit

The Implant is comprised of the Implanted Electronics Unit and one or two ECoG electrodes plus one optional ground (GND) electrode contact

  1. Implanted Electronics Unit
  2. Magnet for suspension of External Unit (location and number of magnets can vary)
  3. Coil for electromagnetic power reception
  4. Hermetic encapsulation of implant electronics
  5. Ground lead (GND) Contact

  6. Electrode cables

  7.  AirRay ECoG electrodes (customizable)

  8. Adapter for commercial DBS Electrodes

Materials
Specifications

External Unit

The External Unit consists of the Head Piece, which supplies power to the Implanted Unit, and the Communication Unit, responsible for secure wireless data exchange with the Implanted Unit.

Magnets ensure proper alignment between the Head Piece and Implanted Unit. The Communication Unit, typically worn on the upper arm, not only facilitates data exchange but also controls power delivery to the Head Piece.

It is directly connected to the computer on which the Application Software is controlling the System. The Application Software is communicating to the Implant via the External Unit.

State of the art encrypted communication between the External Unit and Multi-Part-Implant via a RF link.

Specifications

Computing Unit

The application software runs on a Microsoft Windows 10 computer and represents the interface between the user and the complete system comprising external unit and multi-part implant.

The Application Software runs on a Microsoft Windows-based laptop or tablet and represents the interface between the user and the system.

The Application Software provides users with a graphical user interface. The computer manages the telemetry (programming of stimulation parameters, accessing the system information, and data transmission) and analyses the data.

When requested, the software creates commands, which are sent to the implanted electronics. They translate into stimulation patterns that can modulate the nervous system.

Additionally, it can visualize implant status data such as impedances, humidity and temperature inside the hermetic encapsulation. It is also able to define stimulation signals within the implant’s technical capability and safety limits as well as to execute stimulation commands.

The software has been developed according to IEC 62304.

Specifications

MATERIALS

AirRay Electrodes:

  • Material: Silicone and platinum-iridium (90:10)
  • Alternative materials/coatings available upon request
  • Hybrid silicone-Parylene C substrate recommended for some designs

Ground Electrode:

  • Ring made from platinum-iridium (90:10)
  • Located at the end of a medical-grade silicone tube
  • Connected to the Implanted Internal Electronics Unit

Implanted Internal Electronics Unit:

  • Casted in medical-grade silicon rubber
  • Contains a hermetic ceramic encapsulation for electronic circuit protection

AirRay ECoG Electrodes:

  • Material: Platinum-iridium (90:10), medical-grade silicone rubber, and Parylene C
  • Connection cables: Individually insulated wires bundled in medical-grade silicone tubing

SPECIFICATIONS

FEATURES

Recording channels: 32 

Sampling rate: 1 kHz 

Sampling dynamic range: 16 bit (74 nV smallest increment)

High pass filter cut-off: ca. 2 Hz

Low pass filter cut-off: 325 Hz 

Amplifier band pass gain: Adjustable: 100-750 

Band pass roll-off: 20 dB/dec 

Reference: Any (subset) of the recording channels selectable by software or one dedicated hard-wired additional contact 

Stimulation: Current-controlled, biphasic, rectangular, asymmetric stimulus pulses (cathodic amplitude with pulse width followed by an anodic counter pulse of 1/4x amplitude and 4x pulse width) 

Stimulation channels: 32

Current: Max. -6 mA / +1.5 mA (24 µA increments) within compliance voltage range of -11 V to +5 V 

Current source: Can be directed to any of the 32 electrode contacts 

Pulse width: Negative phase: 10 µs – 2,500 µs 

Power supply: Wireless inductive, 120-140 kHz

Wireless datatransmission: Bi-directional, radio frequency in 2400-2483.5 MHz band 

Closed Loop latency: ≤ 40 ms

SPECIFICATIONS

  • Connection of Communication Unit to Personal Computer with Software Interface: USB 2.0 or 3.0 data transmission
  • Method of keeping Head Piece unit in place: Suspended by magnets
  • Maximum power uptake:
    Limited by USB 2.0 and USB 3.0 specifications (depends on distances between transmitting and receiving coil)
    – USB 2.0 power uptake (~2.5W) for distaces up to 12mm
    – USB 3.0 power uptake (~5W) for distances higher than 12 mm
  • Surface material of Head Piece: PA 2200 (Polyamide 12)
  • Size of Head Piece: 36,4 mm Ø , Height = 9,3 mm
  • Weight of Head Piece: 13 g (without cable)
  • Head Piece cable length: max. 50 cm
  • ETU Head Piece cable: PUR
  • Surface material of external relay unit: ABS (UL 94 HB)
  • Size of Communication Unit: ca. 85 x 95,9 x 48,1 mm3
  • Weight of Communication Unit: ≤ 300g
  • Trigger input of Communication Unit: Analog and digital input with adjustable threshold, suitable e.g. for averaging recorded data on a particular trigger signal and synchronization of multiple implant systems

Brain Interchange Software Specifications

The PC software is designed for interoperative tests.
Its main features are:

  • Live measurement data visualization
  • Establish connection to implants
  • Error display of implants
  • Status display (temperature, humidity, supply voltage)
  • Stimulation function editor (graphical editor for complex stimulation patterns)
  • Definition of reference electrodes for measurement
  • Counter electrode can be selected of any channel incl. ground electrode
  • The system is based on an easily extensible signal processing pipeline so that almost any pattern recognition algorithm or closed-loop stimulation paradigm can be implemented
  • The system can easily be extended by new components
  • Software development according to IEC 62304

Interfaces for implant control on Windows 10 systems

  • C++ API (Attention: Compiler must be compatible)
  • C API (suitable for integration in Matlab, Labview, etc.)
  • Python API (planned)

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