Sterilization methods and apparatus
AssigneeAmaranth Medical Pte.
InventorsKamal RAMZIPOOR, Chang Y. LEE, Fozan O. EL-NOUNOU
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Abstract
Sterilization methods for implantable prostheses are described where a polymeric stent may be sterilized, e.g., via ETO sterilization, at a temperature below a glass transition temperature of the stent. A separate delivery catheter may be sterilized separately and the stent and delivery catheter may then be combined in an aseptic or semi-aseptic environment and sterilized as an assembled system such that the requirements for sterilizing the system are relatively lower. Additionally and/or alternatively, valve and filter assemblies may be used with an optional mandrel assembly for maintaining sterility of the internal components of a catheter system.
Claims12
A system for sterilizing a catheter assembly, comprising:
- a catheter having a proximal end, a distal end, and at least one lumen therethrough;
- one or more valves positioned along the catheter and in fluid communication with the at least one lumen, where the one or more valves are configurable between an opened and closed configuration;
- one or more filters positioned in fluid communication with the one or more respective valves, where the one or more filters are removable from the catheter;
- and,
- a distal end seal which is positionable at the distal end of the catheter and occludes the at least one lumen and is further removable from the distal end of the catheter, where the distal end seal isolates the at least one lumen when positioned at the distal end of the catheter.
The system of claim 1 wherein the distal end seal comprises an elongate mandrel having a plug member sized for insertion into the catheter distal end.
Dependencies are inferred from the claim text.