Sterilization methods and apparatus
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.
1. 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which is positionable at the distal end of the catheter and occludes the at least one lumen and is further removably withdrawn out through the distal end of the catheter, where the distal end seal isolates the at least one lumen when positioned at the distal end of the catheter.
2. The system of claim 1 further comprising a luer assembly coupled to the proximal end and defining a guidewire lumen and an inflation lumen therethrough.
3. The system of claim 1 wherein the one or more valves comprise a stop configurable between the opened and closed configuration.
4. The system of claim 1 wherein the one or more filters are coupled to a proximal end of the one or more respective valves.
5. The system of claim 1 wherein the one or more filters comprise a micro-porous filter.
6. The system of claim 5 wherein the micro-porous filter defines pores of 0.2 μm or less.
7. The system of claim 1 wherein the distal end seal comprises an elongate mandrel having a tapered sealing portion which extends proximally over the mandrel for receiving the catheter distal end.
8. The system of claim 7 wherein the mandrel has a length of 1 cm-160 cm.
9. The system of claim 7 wherein the mandrel has a diameter sized to be slidably inserted into the at least one lumen.
10. The system of claim 7 wherein the mandrel has a length sufficient to extend at least partially through an inflation balloon positioned near or at the distal end of the catheter.
11. 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.
12. The system of claim 1 wherein the distal end seal comprises an elongate mandrel having a tapered portion sized for insertion into the catheter distal end.