Abstract: A sanitary preparation apparatus having a vertically disposed tube, a port coupled to the tube for loading materials, and an end piece coupled to and sealing the bottom end of the tube is disclosed. A slidable platen having substantially the size and shape of the cross section of the tube is provided to close the mixing volume against contamination and to force the prepared material through a sealable connector coupled to the end piece. The platen has a passageway allowing a mixing mechanism including a shaft with attached impeller to be introduced into the mixing volume. One embodiment provides a second volume above the platen in which positive and negative gas pressures can be applied to move the platen within the tube. A method is disclosed for using the sanitary preparation apparatus to prepare a 4% cross-linked polyacrylamide (CPAM) hydrogel and to dispense the gel under pressure.

Abstract: Filling device and method for use in manufacturing of gel filled prostheses which provides fast and accurate filling of prosthesis shells without deterioration of the gel or induction of air into the prosthesis. The filling method utilizes a dual port cannula for penetrating a preslit fill port on a prosthesis shell, the cannula having one port coupled through a flexible tube to a peristaltic pump supplied with gel under pressure, and a second port coupled through a flexible tube to a vacuum system. The cannula and prosthesis shell being filled are supported on a scale, with the flexible tubes being disposed so that pressure variations in the tubes do not effect the scale readings.