System for implantation by sterilisation techniques
AssigneeUniversidade De Santiago De Compostela
InventorsCarlos Alberto Garcia Gonzalez, Victor Santos Rosales, Maria Beatriz Magariños Ferro, Carmen Alvarez Lorenzo
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Abstract
A system for implantation by sterilisation techniques. A sterile implantation system comprising a heat-sensitive polymeric matrix that modifies its structure in the presence of a compressed gas or supercritical fluid to produce a solid or semi-solid with porosity greater than 60%.
Claims19
A sterilization process, comprising the following steps:
- a) introducing the material to be sterilized into an autoclave, and a sterilization additive in concentrations between 100 and 3000 ppm;
- b) heating the system to a temperature of 80° C. or less;
- c) introducing into the autoclave a compressed gas or supercritical fluid at a pressure of between 40 and 300 bar and at a temperature of between 2° and 80° C., and maintaining these pressure and temperature conditions for between 5 minutes and 24 hours;
- d) passing a continuous flow of CO2 of 2 to 500 g/min through the autoclave which is maintained at a pressure of between 40 and 300 bar;
- and at a temperature of between 20 and 80° C., for between 5 minutes and 24 hours;
- and
- e) depressurizing to atmospheric pressure.
An implant or scaffold obtainable by a sterilization process comprising the following steps:
- a) introducing the implant or scaffold to be sterilized into an autoclave, and a sterilization additive in concentrations between 100 and 3000 ppm;
- b) heating the system to a temperature of 80° C. or less;
- c) introducing into the autoclave a compressed gas or supercritical fluid at a pressure of between 40 and 300 bar and at a temperature of between 2° and 80° C., and maintaining these pressure and temperature conditions for between 5 minutes and 24 hours;
- d) passing a continuous flow of CO2 of 2 to 500 g/min through the autoclave which is maintained at a pressure of between 40 and 300 bar;
- and at a temperature of between 2° and 80° C., for between 5 minutes and 24 hours;
- and
- e) depressurizing to atmospheric pressure.
A method for the release of biologically active substances which comprises utilizing an implant or scaffold obtainable by a sterilization process, wherein the process comprises the following steps:
- a) introducing the implant or scaffold to be sterilized into an autoclave, and a sterilization additive in concentrations between 100 and 3000 ppm;
- b) heating the system to a temperature of 80° C. or less;
- c) introducing into the autoclave a compressed gas or supercritical fluid at a pressure of between 40 and 300 bar and at a temperature of between 2° and 80° C., and maintaining these pressure and temperature conditions for between 5 minutes and 24 hours;
- d) passing a continuous flow of CO2 of 2 to 500 g/min through the autoclave which is maintained at a pressure of between 40 and 300 bar;
- and at a temperature of between 2° and 80° C., for between 5 minutes and 24 hours;
- and
- e) depressurizing to atmospheric pressure.
A process for bone regeneration or cartilage regeneration comprising utilizing an implant or scaffold obtainable by a sterilization process comprising the following steps:
- a) introducing the implant or scaffold to be sterilized into an autoclave, and a sterilization additive in concentrations between 100 and 3000 ppm;
- b) heating the system to a temperature of 80° C. or less;
- c) introducing into the autoclave a compressed gas or supercritical fluid at a pressure of between 40 and 300 bar and at a temperature of between 2° and 80° C., and maintaining these pressure and temperature conditions for between 5 minutes and 24 hours;
- d) passing a continuous flow of CO2 of 2 to 500 g/min through the autoclave which is maintained at a pressure of between 40 and 300 bar;
- and at a temperature of between 2° and 80° C., for between 5 minutes and 24 hours;
- and
- e) depressurizing to atmospheric pressure.
Dependencies are inferred from the claim text.