Reduced temperature sterilization of stents

• US 8,309,022 B2
• Filed: 07/08/2011
• Issued: 11/13/2012
• Est. Priority Date: 07/13/2006
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Huang, Bin, Freeman, Abigail, Castro, Daniel, Gale, David C.
• Primary Examiner(s): Yoo, Regina M.
• Application Number:
  US13/179,473
• Publication Number:
  US 20110265426A1
• Time in Patent Office: 494 Days
• Field of Search: 422/1, 422/22, 422/40, 422/291
• US Class Current: 422/22
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/082 X-rays
• CPC Class Codes: A61L 2/085 Infrared radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: B65B 55/00 Preserving, protecting or purifying packages or package contents in association with packaging by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22
• CPC Class Codes: B65B 55/16 by irradiation

Abstract

Methods and systems for reduced temperature radiation sterilization of stents are disclosed.

Claims

1. A method of sterilizing of a stent comprising:

providing the stent in a sealed container, the sealed container having at one side a barrier for scattering radiation and at another side a cavity for holding a cooling member, the cooling member being arranged relative to the stent to maintain at least the stent at a sterilization temperature; and

directing radiation at the container such that the radiation passes through the barrier before reaching the container.

2. A method for sterilizing a stent comprising:

disposing a stent-catheter assembly on or adjacent to a surface of a cooling member, the stent-catheter assembly including the stent;

placing a barrier between at least the stent and a radiation source; and

directing a dose of radiation at the stent;

wherein the cooling member maintains a temperature of the stent at or near a sterilization temperature below ambient temperature and the barrier is configured to increase the uniformity of the dose received by at least the stent and/or to reduce the dose received by at least the stent.

3. The method of claim 2, wherein the barrier is made from a material having micro-voids or particles arranged to scatter radiation to provide a more uniform distribution of the dose.

4. The method of claim 2, wherein the stent is a polymer stent comprising a biostable polymer, biodegradable polymer, or a combination thereof.

5. The method of claim 2, wherein the stent comprises a coating including a biostable polymer, biodegradable polymer, drug, or a combination thereof.

6. The method of claim 2, further including the step of disposing a storage container containing the stent within a cavity of a body of a thermal insulating material, wherein the cooling member is within, or in fluid communication with, the cavity.

7. The method of claim 6, wherein the radiation is directed so that the radiation directed at the stent does not pass through the cooling member.

8. The method of claim 6, wherein the cooling member and the stent are positioned so that the cooling member is not between the directed radiation and the stent.

9. The method of claim 6, wherein the stent is a polymer stent comprising a biostable polymer, biodegradable polymer, or a combination thereof.

10. A method for sterilizing a stent comprising:

disposing a stent-catheter assembly on or adjacent to a surface of a cooling member, the stent-catheter assembly including the stent;

placing a barrier between at least the stent and a radiation source; and

directing a dose of radiation at the stent;

wherein the cooling member maintains a temperature of the stent at or near a sterilization temperature below ambient temperature and the barrier is configured to increase the uniformity of the dose received by at least the stent and/or to reduce the dose received by at least the stent;

wherein the cooling member comprises a slab with a cooling fluid circulating within the slab.