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Organisational structure

The Artificial Heart Laboratory employs a multidisciplinary team of specialists from different fields of science and technology, who cooperate with physicians in Poland’s largest cardiac surgery centres. It establishes cooperation with research institutions in Poland and abroad in terms of material and metrological technologies, nanotechnology, and bioengineering.
The operations of the Laboratory are performed in 4 specialist labs:

Design Lab:

• Design research
• Modelling
• Designing
• Constructing models and prototypes

Test Lab:

• Hydrodynamic tests
• Service tests
• Biocompatibility tests
• Experimental tests
• Clinical tests

 
Technological Lab:

• Manufacture of prototypes of cardiac assist systems
• Manufacture of clinical cardiac assist systems

 
Process Lab:

• Development of polymer processing technologies
• Manufacture of elements of heart prostheses

The Design Lab is engaged in model research and the development of the structure of elements, components, and complete hearth prostheses and controllers thereof, which altogether form mechanical cardiac assist systems. The Lab is equipped with advanced software supporting the process of designing devices and conducting simulations of the phenomena occurring in mathematical models of heart prostheses and elements thereof. The Lab designs pulsatile and centrifugal cardiac assist systems, from models and prototypes through final medical products implemented in the clinical practice. Furthermore, the Lab is a place where interdisciplinary works from the field of the design of power systems and controllers of heart prostheses are performed. The works comprise research on the design, operation, and structure of highly specialised mechatronic miniature power systems of heart prostheses, as well as on the systemic and programmatic structure of microprocessors of systems of control and monitoring of the operations of heart prostheses, as well as power supply systems of heart prostheses based on the application of state-of-the-art battery power supplies along with microcontroller systems of energy transmission and battery charging.
The Test Lab is engaged in the eligibility screening of elements, components, and complete heart prostheses and controllers thereof. The Lab performs hydrodynamic and service tests, as well as a broad array of biocompatibility tests. The Lab is furnished with state-of-the-art control and measurement equipment and software intended for management and collection of experimental data from the domain of flow dynamics in heart prostheses, long-term durability of individual elements and complete prostheses, and experimental tests on animals.
Technical tests on medical products and control systems thereof

• Static and dynamic hydrodynamic tests
• Service tests
• Filtrability tests

In vitro biocompatibility tests of biomaterials and medical products intended for contact with blood

• Tests on haemolysis of biomaterials and products
• Tests on thrombogenicity of biomaterials
• Tests on cytotoxicity of biomaterials
• Tests on acute thrombogenicity of a medical product
• Tests on biodegradation of a biomaterial

In vivo biocompatibility tests of biomaterials and medical products intended for contact with blood

• Tests on local and systemic inflammatory and allergising effect of biomaterials on small animals
• Short- and long-term experimental tests on the implantation of medical products on big animals.

Biocompatibility tests performed in the Lab comprise a multifaceted evaluation of phenomena caused by contact of a biomaterial with a living organism, predominantly in-vitro tests on the effect of the biomaterial surface on blood (coagulation parameters, immuno-enzymatic reactions, haemolysis, cytotoxicity, etc.). In collaboration with external research institutions, the Lab conducts short- and long-term experimental tests on animals evaluating prototypes of medical products, particularly cardiac assist systems developed in the Laboratory. The Lab has developed an original testing method performed on the artificial blood circulation system used as a test stand – the acute thrombogenicity test on fresh animal blood, allowing to evaluate thrombogenic properties of a medical product in lab conditions. The Lab also conducts tests focused on haemolysis on a large volume of blood in circulation (in compliance with the ASTM F 1841 standard), tests of gasometric parameters of blood in extracorporeal circulation by means of an oxygenator, and filtrability tests of vascular prostheses.

GALERY

The Process Lab is engaged in the lab-scale development of technologies of advanced polymer processing and production of elements and components of heart prostheses out of polymers. The Lab develops automated technological processes, designs and manufactures automated technological stations, and performs technological trials. The Lab is a clean zone (ISO 7) and is equipped with state-of-the-art automated technological lamination stations.
The Technological Lab* is engaged in the development of technologies on a scale of batch production, manufacture of heart prostheses as prototype batches intended for pre-clinical and clinical tests and as final medical products applied in the clinical practice.
The Lab is a clean zone (ISO 7) and is furnished with state-of-the-art automated stations for the lamination of elements of heart prostheses and  for the assembly of pulsatile hearth prostheses.


Additional activities of the Artificial Heart Laboratory comprise:

• Development of the quality management system for production of medical products (implants)
• Planning and performing in vitro and in vivo biocompatibility tests on raw materials, biomaterials, medical products (implants) in the scope of the PN EN ISO 10993 standard, including: performance of risk assessment and analysis, development of the profile of necessary biocompatibility tests in compliance with normative requirements, and performance of planned biocompatibility tests along with the results assessment carried out by experts in a given field.
• Organisation of and supervision over the course of clinical tests, in particular: performance of feasibility analyses of clinical tests, negotiating contracts with research centres and individual researchers, registration of tests in the Bioethics Committee and the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, monitoring of clinical trials, data processing in clinical trials (Data Management), and organisation of labour leasing in the scope of clinical trials.