Histology for implantable medical devices2018-10-04T10:27:55+00:00

Histology for implantable medical devices

In the field of biomedical research, evaluation of materials safety is a critical step for the development of implantable medical devices. That’s why our laboratory has developed a new services of histopathology for implanted biomaterials. It enables to cut and analyze all kind of devices, preserving the integrity of adjacent structures.

Please find here our brochure about Biocompatibility on medical devices

Histology for implanted biomaterials

This histology service has been specifically developed for the needs of biomedical research on implanted medical devices.

The analysis of such devices uses innovative histological resources to achieve micrometric sections of high density tissues, embedded in resin. This method preserves the tissues structures in compliance with the standard NF EN ISO 10993-6 “Biological evaluation of medical devices”; it allows to measure:

  • Osteo-integration of implanted medical devices (tissue and matrix level)
  • Tolerance by the body and safety (biocompatibility)
  • Distortions (loadt resistance and ductility of materials)
  • Deteriorations (corrosion resistance)

Our services are suitable with all kinds of medical devices: I, IIa, IIb and III (annexe IX of 93/42/CEE directive).

Acrylic thermoplastic resins

We provide inclusions in two kind of resins in order to meet all our customer needs

These techniques of inclusion have different characteristics than paraffin’s inclusions:

  • Resin is easier to handle and much more tough
  • The realization of thin sections is possible (up to 5 µm)
  • Resin offers the opportunity to cut all kinds of implants, tissues and biomaterials

However, the panel of histological staining is as important as paraffin and it is possible to perform immunolabeling.

The inclusion is made by polymerization of our MMA and GMA resins in controlled conditions and in suitable molds.

GlycolMethAcrylate Resin (GMA)

MethylMethAcrylate Resin (MMA)

  • Resin the most used in histology
  • Very hydrophilic and easy to stain
  • Deplastification is unnecessary after the cutting
  •  Resin denser
  • Use for all kind of materials
  • Deplastification necessary
  • Staining and immunolabeling possible

Methods of cutting

To obtain histological slides, we propose different methods adapted to our customer needs:

Cutting with diamond saw

This method is more suitable for the cutting of high density biomaterials (implanted medical devices, prosthesis…), embedded in Methylmethacrylate resin:

1. Cutting

The diamond saw system is able to cut implanted tissues and bones with high quality and precision.

This technique preserves all tissue structures even when they have different densities.

2. Polishing blocks

The polishing system reduces the thickness of the sample until the desired one with high accuracy and without artifact.

It is thus possible to obtain sections up to 10 µm of thickness, which is ideal to perform histological studies.


Laser sactionning

It is the quickest and more precise method. It allows to obtain sections to 1 to 10 µm of thickness and is suitable for all kind of tissues embedded in GMA/MMA resins. However, it does not allow cutting of metals and ceramics. The femtosecond laser preserves the warming of the samples when the section is performed.

Advantages

 

Our histological service for implanted biomaterials allows to:

  • Reduce cutting forces (friction and warming)
  • Reduce artefacts
  • Better preservation of tissue structures.
  • Perform cutting across all high density tissues (bones without decalcification)
  • Perform cutting across materials used in medical devices: metals (titanium alloys, cobalt, surgical steel …), ceramics, polymers…
  • Compliance with the standard NF EN ISO 10993-6