Device Histopathology Overview
CBI provides a complete range of device histopathology assessments, including macroscopic dissection, sample preparation, photographic documentation, plastic sectioning and ground sections. Our experienced pathologists supervise all aspects of protocol preparation, device preparation, evaluation and morphometery on a variety of materials including implants, metals, plastics and polymers.
Plastic sections are used for the evaluation of non-decalcified bone, devices such as stents or bone pins and implanted material such as suture. Hard biological tissue, such as bone and tissue containing metal can be embedded in plastics, sectioned with a high-speed saw and either ground to a thickness suitable for histological examination or sectioned with a tungsten knife.
Following gross trimming and orientation, plastic sections are prepared by infiltrating and embedding tissues into a plastic resin such as glycol methacrylate or methyl methacrylate or other appropriate resin. Cured tissues are sawed with a diamond saw and either prepared as 5 mm ground sections or cut with a tungsten knife. Sections may be stained with routine hematoxylin eosin; special stains including toluidine blue, trichrome, Movat’s pentachrome or Van Geisen’s. Immunohistochemistry may also be performed. Dramatic photographs can be provided that are suitable for regulatory purposes and publication.
Resin embedding and grinding facilitates hard implants to be processed while maintaining intimate contact with surrounding tissue and permits the routine high-quality processing of soft implants in hard tissue without decalcification.
Device, Plastics and Ground Section Capabilities
- Artificial cartilage and cartilage implants
- Bone cements
- Bone plates, pins and screws
- Bone/spine fusion polymers
- Drug-coated beads
- Implanted suture material and catheters
- Metallic intravascular stents and vascular filters
- Mineralized or demineralized
- Ophthalmic implants
- Stem cell devices
- Total hip prosthesis