GLP Research Unit – Implantation – In brain tissue

Biomaterials are materials that are used in medicine and biology, usually in the context of interaction with living organisms. They can be used for a variety of purposes, such as healing, repairing or replacing tissues and organs in human or animal organisms. Biomaterials are widely used in the fields of tissue engineering, surgery, neurology, dentistry, orthopedics and many other medical fields.

Biomaterials must meet certain basic criteria to be effective and safe for use in organisms. These criteria include:

• Biocompatibility: Biomaterials should not induce excessive immune reactions or toxicity in organisms. They must be compatible with the organism to avoid rejection.
• Resistance to degradation: Biomaterials must be durable and resistant to degradation within organisms. However, in some cases, controlled degradation of the biomaterial may be desirable when it serves its purpose, such as in the case of absorbable surgical sutures.
• Mechanical properties: Biomaterials must possess mechanical properties suitable for their intended application. For instance, biomaterials used in bone implants must be sturdy, while those used in heart prostheses must be flexible.
• Biopermeability: Some biomaterials need to be permeable to nutrients and gases to facilitate communication between the organism and the material.
• Sterility: Biomaterials must undergo a sterilization process to prevent infections.

Brain implants, also known as neuroimplants or deep brain electrodes, are medical devices implanted into the brain for the purpose of monitoring or modulating neuronal activity. These advanced technologies are used in the treatment of various neurological and psychiatric disorders, as well as in scientific research related to the brain. Brain implants represent a rapidly evolving field in the realms of neurology and neuroinformatics. They aid in understanding and treating severe brain disorders and may open doors to new possibilities in brain-computer interfaces. However, their use requires caution and a thoughtful assessment of benefits and risks for the patient.

When assessing the biocompatibility of brain implants, a series of tests, in vitro and in vivo studies, and clinical evaluations are conducted. All of these aim to ensure that the biomaterial or device is safe and effective when in contact with the organism. Medical products that do not meet biocompatibility standards are typically not approved for clinical use. For medical devices, biocompatibility assessment is carried out following guidelines ISO 10993-6 – Tests of local effects after implantation.

The Silesian Park of Medical Technology Kardio-Med Silesia is certified by Good Laboratory Practice in the biocompatibility (scope 9) for biological evaluation of medical devices for in vitro testing, among others.

Feel free to contact us to match the appropriate testing method to your medical device.