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Control for Cardiac Support System

Product: Circulite
Complete Control Unit for Cardiac Support System

Starting Point

Cardiac support systems (LVAD) require an intelligent control of battery management as well as a reliable transfer of control data to the extracorporeal components. Contracted by a manufacturer of LVAD cardiac support systems, em-tec developed a complete control unit consisting of a controller, batteries and power pack, as well as a system monitor and configuration device.

Implementation

The control system regulates the entire power management, saves data and controls the LVAD pump. Additionally, it also incorporates an alarm system. The battery module and the charger are both equipped with an intelligent charge management and thus enable continuous battery care and ensure long usage times. To charge on the go, an additional car adapter was developed. A system monitor provides the collected control data for the read-out. A special configuration device also enables the setting of the LVAD pump during the minimally invasive implantation.

Result

With this contract development, em-tec presents a compact control system with good usability, long battery runtimes, comprehensive data display and configuration support during the implantation. All processes concerning quality assurance, documentation and clinical approval were also handled by em-tec so that the customer received a fully functional, tested and market-approved system, which has been successfully implanted to patients for several years.

Customer
Circulite

Contract Development
Control unit for minimally invasive cardiac support pump (LVAD)

Research Time
5 years

EU Research Project

Product: TET-System SensorArt
EU research project concerning the transcutaneous energy transfer for cardiac systems

Starting Point

Active implants such as cardiac support systems (VAD) or total artificial hearts (TAH) have to be continuously supplied with energy due to their high energy demand. Implanted batteries are not yet efficient enough for the required output of 15 to 30 watt. Consequently, the device needs to be supplied from the outside via a cable connection. This does not only come with severe disadvantages for the patients (e.g. when it comes to showering or getting dressed), but it also increases the risk of infection and injury. Furthermore, real artificial hearts with an energy demand of 25 to 30 watt need an even thicker, and thus rather rigid, cable, which further complicates the patients' everyday life.

Implementation

In the course of the EU research project "SensorArt", the transcutaneous energy transfer for cardiac systems was developed and tested. With this method, the energy transfer is completely wireless through the skin by means of the inductive connection of two TET magnetic coils (one inside as well as a second one outside the body). In addition to the energy transfer in the range of 15 to 30 watt, this system can also be used for the wireless transmission of sensor data. What is challenging here is, aside from the generation of heat and the risk of injury connected to it, also the stable energy transfer. This can only be ensured if both TET induction coils lie exactly on top of each other. Furthermore, it is dependent on the thickness of the tissue that needs to be penetrated..

Result

During the five-year long research process of this project, em-tec was able to prove the general functionality of a transcutaneous energy transfer for cardiac systems. By doing so, we completed the preliminary stage of a serial development. We were also able to gain central insights into the application of wireless TET systems, their implantability and the problems linked to them. In the course of further research projects, as well as an externally commissioned product development, em-tec is currently advancing this technology to market maturity direction.

Customer
Research project of the EU

Contract Development
Transcutaneous energy transfer for cardiac systems via a TET coil

Research Time
5 years

Dialysis: Blood Volume Module

Product: Blood Volume Module BVM
Measurement of the relative blood volume during dialysis

Starting Point

An external client who develops and sells complete dialysis products, was looking for a sensoric measurement extension in order to record the degree of drainage during the dialysis as exactly as possible. The additional measurement data should facilitate the analysis of the dialysis' efficiency and enable a better adjustment of the dialysis to every patient individually.

Implementation

The task was to integrate an additional sensor for the non-invasive measurement of the relative blood volume—based on the hematocrit value—throughout the dialysis' process into the existing dialysis product.

Key factors throughout the development were, for one, to ensure the fit so that the module can be integrated into the pre-defined shaft within the device. The transmission of the measurement parameters to the given data interface should take place via a plug connection. It was important that the tubes of the dialysis device can be exactly integrated into the mounting in an easy and uncomplicated manner in order to ensure error-free measurements. For another, the regulatory framework according to DIN ISO 13485 and Medical Device Regulation (MDR) had to be abided by to ensure the certification of the additional module.

em-tec developed a completely new measuring module based on the opto-acoustic resonance principle. This principle first stimulates the erythrocytes with a laser beam. After that, one can exactly measure the relative blood volume and thus the degree of drainage by using the resonance method based on the ultrasonic transit time method.

Result

em-tec realized the complete development and supply of certification documents for the measurement module according to the client's task definition. Since the module is still manufactured in-house in the required quantity, the client can always contact us in regard to necessary changes and adjustments for future device generations with next to no effort. A comprehensive accompanying quality management in both developmental as well as manufacturing processes ensures the compliance with all regulatory requirements at all times.

Contract Development
Development: relative blood volume meter for integration into an existing dialysis product

Measurement methods used: TTFM, OAR

Dialysis: Battery Module for Shunt Flow Device

Product: Battery Module
Measurement of the relative blood volume during dialysis

Starting Point

A customer successfully develops measurement devices to evaluate the condition of dialysis shunts using a flow method. During everyday operation, however, it became apparent that a mobile use of the measurement device without a power supply line would do the requirements of the clinical operation much more justice, as this would avoid the currently necessary powering on and off of the device at every power loss. It would also allow for more flexibility concerning possible applications.

Implementation

em-tec developed and realized a 100 Wh battery module for a shunt flow measurement device. It can be retroactively interfaced and rigidly connected to the device.

Result

The development facilitates a comparatively cost-effective upgrade of the existing measurement device and thus allows for a mobile application between several beds in a dialysis center. All the required certifications for the retroactive extension were taken care of by em-tec. The same applies to the complete documentation, the quality assurance and a comprehensive quality management.

Customer
d.med

Contract Development
Battery module for a device measuring the shunt flow during dialysis

Implementation Period
4 months

Control Unit for Minimally Invasive Cardiac Support Pump and Total Artificial Heart

Product: ReinHeart VAD
Case study control unit for minimally invasive cardiac support pump and total artificial heart

Starting Point

Cardiac support systems (LVAD) and total artificial heart systems (TAH) require an intelligent control of the battery management as well as a reliable transfer of control data to the extracorporeal components. Contracted by ReinHeart and ReinVAD, em-tec is currently developing a complete control unit consisting of a controller, batteries and power packs, system monitor and implantable drive control (TAH) for a LVAD pump as well as an total artifical heart.

Implementation

A control system regulates the complete power management, saves the data and controls the LVAD pump or TAH respectively. Additionally, it incorporates an alarm system. The battery module and the charger are equipped with an intelligent charge management and enable a continuous battery care for long utilization periods. A system monitor provides the collected control data for the read-out, and supports the configuration during the surgery. For the TAH, an implantable drive control is being developed. For the implementation, em-tec refers to the successful development of a LVAD control unit for the Circulite.

Result

For the development, em-tec was able to fall back on their specific know-how in the fields of battery management, data management, safety architecture as well as LVAD control and the application of flow sensors. All specifications are developed together with the customer and the involved suppliers in order to present a complete system that is tested, medically certified and optimally tailored to the customer's requirements. Everything concerning quality assurance, quality management and complete documentation was also centrally handled by em-tec.

Customer
ReinHeart, ReinVAD

Contract Development
Control unit for minimally invasive cardiac support pump (LVAD) as well as a total artificial heart (TAH)

Research Time
3 years