Radiation sterilization of medical devices

• US 7,959,857 B2
• Filed: 06/01/2007
• Issued: 06/14/2011
• Est. Priority Date: 06/01/2007
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Simmons, Greg, Harrison, Robert, Riggs, Brian, Freeman, Abigail
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Chorbaji; Monzer R
• Application Number:
  US11/809,511
• Publication Number:
  US 20080299002A1
• Time in Patent Office: 1,474 Days
• Field of Search: 422/1, 422/22, 422/186.05, 250/389, 250/427, 250/433, 250/453.11, 250/455.11, 250/492.3, 250/515.1, 600/434, 600/585, 606/191, 606/194, 606/198
• US Class Current: 422/22
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

Disclosed herein is a method of radiation sterilizing a plurality of medical devices.

Claims

1. A method of radiation sterilizing a plurality of stent-catheter assemblies, the method comprising:

Positioning a plurality of stent-catheter assemblies on a fixture, each of the stent catheter assemblies being arranged in a planar configuration and disposed in corresponding planar packaged supported on the fixture, wherein the packages are stacked horizontally on the fixture, and wherein the stents of the assemblies are positioned at a position in each package such that the stents are exposed to the same or substantially the same radiation; and

Exposing the packages to an incoming radiation beam, the radiation beam being at an acute angle to the planes of the planar configuration of the assemblies, wherein the packages are arranged such that a front end of the stack faces the radiation beam and a back end of the stack faces away from the radiation beam, wherein a radiation shield is positioned at the front end of the stack to reduce radiation exposure to selected assemblies adjacent the front end from the incoming radiation.

2. The method according to claim 1, wherein the radiation beam comprises an e-beam radiation beam.

3. The method according to claim 1, wherein the planar packages in the stack are staggered along an edge of the stack facing the radiation beam.

4. The method according to claim 1, wherein radiation shield is positioned and the properties of the radiation shield are selected such that variation in radiation exposure to the selected assemblies from incoming radiation and the other assemblies in the stack is reduced, substantially eliminated, or eliminated.

5. The method according to claim 1, wherein the stents of the assemblies are positioned at a position in each package such that the stents are exposed to the same or substantially the same radiation.

6. The method according to claim 1, wherein each of the stent catheter assemblies are arranged in a coiled configuration.

7. The method according to claim 1, wherein the incoming radiation is 35-45 KGy and the stent in each of the assemblies is positioned at 36°

-108°

in the coiled configuration.

8. The method according to claim 1, wherein the acute angle is 35°

-45°

.

9. The method according to claim 1, wherein exposing the packages to a radiation beam comprises movement of the fixture with respect to the incoming radiation beam.

10. The method according to claim 9, wherein the assemblies are sufficiently sterilized after one movement of the fixture with respect to the incoming radiation beam.

11. The method according to claim 1, wherein the assemblies are cooled prior to, during or after positioning the assemblies on the fixture.

12. A method of radiation sterilizing a plurality of stent-catheter assemblies, the method comprising:

Positioning a plurality of stent-catheter assemblies on a fixture, each of the stent catheter assemblies being arranged in a planar configuration and disposed in corresponding planar packages supported on the fixture, wherein the packaged are stacked horizontally on the fixture, and wherein the stents of the assemblies are positioned in each package such that the stents are exposed to the same or substantially the same radiation; and

Exposing the packages to an incoming radiation beam, the radiation beam being at an acute angle to the planes of the planar configuration of the assemblies, wherein the packages are arranged such that a front end of the stack faces the radiation beam and a back end of the stack faces away from the radiation beam, wherein a radiation shield is positioned at the back end of the stack to reduce backscatter of radiation from a support element of the fixture to selected assemblies adjacent the back end.

13. The method according to claim 12, wherein the radiation shield is positioned and the properties of the radiation shield are selected such that a variation in radiation exposure from backscattered radiation to the selected assemblies and the other assemblies in the stack is reduced, substantially eliminated, or eliminated.

14. A method of radiation sterilizing a plurality of medical devices, the method comprising:

positioning a plurality of medical devices on a fixture; and

exposing the devices to an incoming radiation beam through movement of the plurality of devices with respect to a radiation source, wherein the number of devices through which the radiation beam passes varies with the movement, wherein a radiation shield is positioned such that a variation in radiation exposure among the medical devices from incoming or backscattered radiation is reduced.

15. The method according to claim 14, wherein the radiation shield is positioned between a support element of the fixture and selected devices, the radiation shield reducing radiation exposure from backscattering from the support element to the selected devices.

16. The method according to claim 14, wherein the radiation shield is positioned between the incoming radiation beam and selected devices, the radiation shield modifying radiation exposure from the incoming radiation to the selected devices.

17. The method according to claim 14, wherein the radiation shield comprises foam.

18. The method according to claim 14, wherein the devices are cooled prior to, during or after positioning the devices on the fixture.

19. The method according to claim 14, wherein a selected portion of each of the devices are positioned such that the selected portion of each of the devices is exposed to the same or substantially the same radiation.

20. A method of radiation sterilizing a plurality of medical devices, the method comprising:

only one cooling step, wherein in the only cooling step a plurality of medical devices are cooled;

positioning the plurality of medical devices on a fixture;

positioning a radiation shield relative to the medical devices such that a variation in radiation exposure among the medical devices from incoming or backscattered radiation is reduced; and

only one sterilizing step, wherein in the only sterilizing step there is only one pass of a radiation beam to expose the plurality of medical devices to radiation.

21. The method according to claim 20, wherein the radiation shield is positioned between a support element of the fixture and selected devices, the radiation shield reducing radiation exposure from backscattering from the support element to the selected devices.

22. The method according to claim 20, wherein the radiation shield is positioned between the incoming radiation beam and selected devices, the radiation shield modifying radiation exposure from the incoming radiation to the selected devices.

23. The method according to claim 20, wherein the radiation shield comprises foam.

24. A method of sterilizing a stack of packages of medical devices, the method comprising:

placing a stack of packages of medical devices horizontally on a fixture having a support element, the step of positioning the stack including;

placing the stack between a radiation source and the support element of the fixture,

staggering the stack of packages horizontally so that there is a non-overlapping portion between adjacent packages, and

positioning the stack of packages so that faces of the packages are at an acute angle relative to a radiation beam from the radiation source;

positioning a radiation shield relative to the stack of packages such that a variation in radiation exposure among the medical devices from incoming or backscattered radiation is reduced; and

exposing the packages to an incoming radiation beam.

25. The method of claim 24, wherein each medical device is placed in the same horizontal and vertical positions within the package.

26. The method of claim 25, wherein the step of positioning a radiation shield includes positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation.

27. The method of claim 26, wherein the step of positioning a radiation shield includes positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack.

28. The method of claim 27, wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages.

29. The method of claim 24, wherein the step of positioning a radiation shield includes positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation.

30. The method of claim 29, wherein the step of positioning a radiation shield includes positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack.

31. The method of claim 30, wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages.

32. The method of claim 31, wherein the packages are exposed to the incoming radiation beam to irradiate the packages substantially uniformly.

33. The method of claim 24, wherein the step of positioning a radiation shield includes positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack.

34. The method of claim 33, wherein the thickness and/or density of the radiation shield is varied to obtain a desired exposure to the packages.

35. The method of claim 34, wherein the packages are exposed to the incoming radiation beam to irradiate the packages substantially uniformly.

36. The method of claim 24, wherein the packages are exposed to the incoming radiation beam to irradiate the packages substantially uniformly.

37. A method of sterilizing a stack of packages of medical devices, the method comprising:

Placing a stack of packages of medical devices horizontally on a fixture having a support element, the step of positioning the stack including;

Placing the stack between a radiation source and the support element of the fixture,

Staggering the stack of packages horizontally so that there is a non-overlapping portion between adjacent packages, and

Positioning the stack of packages so that faces of the packages are at an acute angle relative to a radiation beam from the radiation source,

Wherein each medical device is not placed in the middle of the package, and wherein each medical device is placed in the same horizontal and vertical positions within the package;

Exposing the packages to an incoming radiation beam, and positioning a radiation shield relative to the stack of packages such that a variation in radiation exposure among the medical devices from incoming or backscattered radiation is reduced.

38. The method of claim 37, wherein the step of positioning a radiation shield includes positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation.

39. The method of claim 38, wherein the step of positioning a radiation shield includes positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack.

40. The method of claim 39, wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages.

41. The method of claim 37, wherein the step of positioning a radiation shield includes positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack.

42. The method of claim 41, wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages.

43. A method of sterilizing a stack of packages of stents, the method comprising:

placing a stack of packages of stents horizontally on a fixture having a support element, the step of positioning the stack including;

placing the stack between a radiation source and the support element of the fixture,

staggering the stack of packages horizontally so that there is a non-overlapping portion between adjacent packages, and

positioning the stack of packages so that faces of the packages are at an acute angle relative to a radiation beam from the radiation source,

wherein each stent is not placed in the middle of each package, and wherein each stent is placed in the same horizontal position within the package, each stent is placed in the same vertical position within the package, or each stent is placed in the same horizontal and vertical positions within the package;

positioning a radiation shield relative to the stack of packages such that a variation in radiation exposure among the stents from incoming or backscattered radiation is reduced, wherein the step of positioning a radiation shield includes

positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation, and

positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack,

wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages; and

exposing the packages to an incoming radiation beam, wherein the packages are irradiated substantially uniformly.

44. A method of sterilizing a stack of packages of stents, the method comprising:

placing a stack of packages of stents horizontally on a fixture having a support element, the step of positioning the stack including;

placing the stack between a radiation source and the support element of the fixture,

staggering the stack of packages horizontally so that there is a non-overlapping portion between adjacent packages, and

positioning the stack of packages so that faces of the packages are at an acute angle relative to a radiation beam from the radiation source;

positioning a radiation shield relative to the stack of packages such that a variation in radiation exposure among the stents from incoming or backscattered radiation is reduced, wherein the step of positioning a radiation shield includes

positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation, and

positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack,

wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages; and

exposing the packages to an incoming radiation beam, wherein the packages are irradiated substantially uniformly.

45. A method of sterilizing a stack of packages of stents, the method comprising:

placing a stack of packages of stents horizontally on a fixture having a support element, the step of positioning the stack including;

placing the stack between a radiation source and the support element of the fixture,

staggering the stack of packages horizontally so that there is a non-overlapping portion between adjacent packages, and

positioning the stack of packages so that faces of the packages are at an acute angle relative to a radiation beam from the radiation source,

wherein each stent is not placed in the middle of each package, and wherein each stent is placed in the same horizontal and vertical positions within the package;

positioning a radiation shield relative to the stack of packages such that a variation in radiation exposure among the stents from incoming or backscattered radiation is reduced, wherein the step of positioning a radiation shield includes

positioning a radiation shield at the front end of the stack to reduce radiation exposure to one or more packages in the front end from incoming radiation, and

positioning a radiation shield at the back end of the stack to reduce backscatter of radiation from the support element of the fixture to one or more packages in the back end of the stack,

wherein the thickness and/or density of at least one of the radiation shields are varied to obtain a desired exposure to the packages; and

exposing the packages to an incoming radiation beam, wherein the packages are irradiated substantially uniformly.