Reduced temperature sterilization of stents

Patent metadata

Field	Value
Publication number	US-9339568-B2
Application number	US-201414263952-A
Country	US
Kind code	B2
Filing date	Apr 28, 2014
Priority date	Jul 13, 2006
Publication date	May 17, 2016
Grant date	May 17, 2016

Abstract

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

First claim

What is claimed is:

1. A method for packaging a medical device, comprising:
providing a stent-catheter assembly including a polymer stent crimped to a balloon of a balloon catheter;
directing a dose of radiation at the stent-catheter assembly sufficient to satisfy a sterility assurance level (SAL); and
reducing the temperature of the stent-catheter assembly after directing the dose of radiation at the stent-catheter assembly.

2. The method of claim 1 , further including placing a barrier between the stent-catheter assembly and a radiation source, which provides the dose of radiation, wherein the barrier is made from a material having micro-voids or particles arranged to scatter radiation to provide a more uniform distribution of dose.

3. The method of claim 1 , wherein the polymer stent comprises a biostable polymer, bioabsorbable polymer, biodegradable polymer, or a combination thereof.

4. The method of claim 3 , wherein the bioabsorbable polymer comprises PLLA or a PLLA and PDLA blend which forms a stereocomplex.

5. The method of claim 3 , wherein the bioabsorbable polymer has a glass transition temperature at least 10° C. greater than human body temperature.

6. The method of claim 1 , wherein the polymer stent comprises a coating including a biostable polymer, bioabsorbable polymer, biodegradable polymer, drug, or a combination thereof.

7. The method of claim 1 , wherein the radiation is selected from the group consisting of e-beam, gamma ray, ultraviolet, infra-red, ion beam, x-ray, and laser.

8. The method of claim 1 , wherein the stent-catheter assembly temperature is reduced to below 0° Celsius and the bioabsorbable polymer comprises PLLA.

9. The method of claim 8 , wherein the stent-catheter assembly is within a sealed, flexible pouch and the stent-catheter assembly receives the dose of radiation while contained within the sealed flexible pouch.

10. The method of claim 9 , wherein the stent-catheter assembly temperature is reduced using ice, dry ice, or a freezable gel.

11. A method for packaging a medical device, comprising:
exposing the medical device comprising a polymer stent to a dose of radiation to sterilize the stent; and
after exposing the polymer stent to the dose of radiation, disposing the polymer stent in a container for storing the polymer stent;
wherein a cold medium is disposed within the container, the cold medium reducing and maintaining the temperature of the polymer stent below ambient temperature.

12. The method of claim 11 , wherein the cold medium reduces the temperature of the polymer stent to below 0° C.

13. The method of claim 11 , wherein the cold medium is selected from the group consisting of ice, dry ice, and freezable gel.

14. The method of claim 11 , wherein the polymer stent comprises a biostable polymer, bioabsorbable polymer, biodegradable polymer, or a combination thereof.

15. The method of claim 11 , wherein the polymer stent comprises a coating including a biostable polymer, biodegradable polymer, drug, or a combination thereof.

Assignees

• Abbott Cardiovascular Systems
• Abbott Cardiovascular Systems

Inventors

• Huang Bin
• Freeman Abigail
• Castro Daniel
• Gale David C

Classifications

• A61L2103/23

  Containers other than laboratory or medical, e.g. bottles or mail · CPC title

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2/087

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• B65B55/16

  by irradiation · CPC title

• A61L2/08 Primary

  Radiation · CPC title