BIOCOMPATIBLE MEDICAL DEVICE AND METHOD OF MAKING SAME

Traumatic brain injury is the leader in the ranking of mortality and invalidity. The surgical repair of a defect of the skull by cranioplasty has been practiced since ancient times, when materials of non-biological origin were used for this purpose. New materials and processes are sought to improve osseintegration of implants. Like any surgical procedure, cranioplasty involves complications that may be related to the surgical technique and/or to the patient’s tolerance to the material used. This patent describes a biocompatible medical device that include two supported meshes for providing mechanical strength and osseointegration properties of the implant, and a multiplayer porous material in between them that is loaded with the required bioactive antibacterial compound to promote a controlled and sustained release of the pharmaceutical agents at the site of surgical intervention. To increase osseointegration, meshes are designed with an open structure and coated with biocompatible materials such as hydroxyapatite.

The composition gradient in the multilayer porous material is attained by loading successive layers of porous material with different amounts of bioactive materials and then stacking them to create a gradient of composition across the porous material.

The present invention describes method(s) to place, fix and fasten the medical device to the bone structure. More particularly, the present invention relates to a method for accelerating the transport of the incorporated drug from the inner layers to the outer edge of the outer layer. The present invention describes a clamping system that provides a fast attachment of the biocompatible medical device to the bone structure and a rapid placement of the three layers of material with different properties: i.e. the two meshes that promote osseo-integration of the implant and one multilayer porous material loaded with bioactive compounds having a gradient composition to control the release of the drugs incorporated in the porous material.

US Patent Application 38170047/2019