Sterilization methods for medical devices
First Claim
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1. A method of sterilizing a stent, the method comprising:
- exposing the stent to a sterilizing chemical at ambient temperature;
performing one or more processing operations on the exposed stent; and
packaging the processed stent, wherein the sterility assurance level (SAL) of the packaged stent is less than a selected value due to the exposure to the sterilizing chemical.
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Abstract
Methods of sterilizing medical devices, including implantable medical devices like stents, chemically and with radiation are disclosed. Methods of preparing a sterile, packaged medical device, including a sterile, packaged implantable medical device or stent are disclosed.
73 Citations
31 Claims
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1. A method of sterilizing a stent, the method comprising:
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exposing the stent to a sterilizing chemical at ambient temperature;
performing one or more processing operations on the exposed stent; and
packaging the processed stent, wherein the sterility assurance level (SAL) of the packaged stent is less than a selected value due to the exposure to the sterilizing chemical. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for preparing a sterilized packaged stent, the method comprising:
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exposing a stent comprising a polymer to radiation to sterilize the stent while the stent is in an uncrimped state; and
packaging the stent. - View Dependent Claims (20, 21, 22, 23, 24)
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25. A method of preparing a sterilized, packaged stent, the method comprising:
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exposing the stent to a fluid to a cleaning fluid in preparation for a coating operation;
exposing the stent to a sterilizing chemical at ambient temperature;
coating the stent; and
heating the stent after coating, wherein the stent comprises a polymer. - View Dependent Claims (26, 27, 28, 29, 30)
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31. A method of preparing a sterilized, packaged stent, the method comprising:
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exposing the stent to a cleaning fluid in preparation for a coating operation;
coating the stent; and
heating the stent after coating;
mounting the stent onto a delivery device and attaching the mounted stent to a delivery system;
packaging the stent and delivery system; and
exposing the packaged stent and delivery system to radiation of not more than 15 KGy after packaging the stent;
wherein the stent comprises a polymer.
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Specification