Delivery system and prescription method for interstitial radiation therapy using enhanced parametric release sterilization techniques

• US 7,540,998 B2
• Filed: 11/12/2004
• Issued: 06/02/2009
• Est. Priority Date: 11/19/2003
• Status: Expired due to Fees

• Current Assignee: Theragenics Corporation (Juniper Investment Co. LLC)
• Original Assignee: Biocompatibles Incorporated (Boston Scientific Corporation)
• Inventors: Terwilliger, Richard A., Lamoureux, Gary A.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Chorbaji; Monzer R.
• Application Number:
  US10/987,141
• Publication Number:
  US 20050191207A1
• Time in Patent Office: 1,663 Days
• Field of Search: 422/1, 422 28- 30, 422/32, 422/34, 422/305, 600/1, 600/3, 600 7- 8, 604/48, 604/57, 604/59, 604/60
• US Class Current: 422/28
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

A process is provided for sterilizing brachytherapy devices with Ethylene Oxide gas and releasing the devices on a parametric release basis. Devices that can be sterilized with this process include interstitial radiation seed strand implants and the needles used for implantation. In order to be sterilized effectively by EtO gas, the devices are constructed such that surfaces not readily infused with EtO gas are made to be gas permeable, and will not retain the gas after the sterilization process. Performance qualification of the sterilization process is performed through physical and microbiological studies, and set of established physical process parameters. Maintaining the physical process parameters in subsequent sterilization cycles will consistently yield the desired sterility assurance level without having to test the devices for sterility.

Claims

1. A method of sterilizing a brachytherapy device comprising the steps of:

assembling the brachytherapy device by loading a radioactive seed implant into a delivery needle;

arranging a gas permeable safety plug over a distal end of the delivery needle;

inserting a stylet into a proximal end of the needle so that a portion of the stylet extends out from the delivery needle;

positioning the brachytherapy device in a tray by securing the distal end of the delivery needle to the tray and securing the portion of the stylet to the tray so as to resist relative movement of the stylet and the delivery needle;

packaging the brachytherapy device and the tray in a gas permeable package;

exposing the brachytherapy device and the package to a sterilizing gas;

sterilizing the brachytherapy device using a set of process parameters that provide a prescribed level of sterilization; and

parametrically releasing the brachytherapy device from the sterilization process.

2. The method of claim 1 wherein the sterilizing step further comprises using at least one of the process parameters selected from the group consisting of load configuration, temperature, pressure, time, and gas concentration.

3. The method of claim 1 wherein said radioactive seed implant is a radioactive seed strand.

4. The method of claim 1, the sterilizing step further comprising using ethylene oxide gas to sterilize the brachytherapy device.

5. The method of claim 1 including maintaining a temperature for the sterilization step between 45°

C. and 55°

C.

6. A method of sterilizing at least one brachytherapy device, comprising steps of:

providing an open, sealable diffusion bag to contain said at least one brachytherapy device;

receiving a tray including the at least one brachytherapy device comprising a radioactive seed implant arranged in a delivery needle and a stylet arranged at least partially in the delivery needle so that a portion of the stylet extends out from the delivery needle;

wherein the delivery needle is secured to the tray and the portion of the stylet is secured to the tray so as to resist relative movement of the stylet and the delivery needle;

placing said at least one brachytherapy device and said tray into an interior of the open diffusion bag;

evacuating air from the diffusion bag;

sealing the diffusion bag;

positioning the diffusion bag in a chamber of a sterilizer having a ventilation system for removal of an exhaust gas from the chamber;

providing a sterilizing atmosphere in the interior of the diffusion bag by releasing into the diffusion bag ethylene oxide gas at a concentration sufficient to act as a sterilant;

heating ethylene oxide gas to an appropriate temperature;

maintaining the temperature of the ethylene oxide gas for a sufficient time to sterilize the at least one brachytherapy device.

7. The method of claim 6, including the step of selecting the diffusion bag constructed of a material that allows ethylene oxide gas to outwardly diffuse from the diffusion bag.

8. The method of claim 6, including the step of selecting the diffusion bag constructed of a tear-resistant material.

9. The method of claim 6, including the step of selecting the diffusion bag constructed of low density polyethylene.

10. The method of claim 6, including the step of selecting the diffusion bag being hermetically-sealed to form a substantially leak-proof seal.

11. The method of claim 6, including the step of releasing the ethylene oxide into the diffusion bag by a delivery mechanism.

12. The method of claim 11, including the step of choosing the delivery mechanism to be a cartridge containing ethylene oxide.

13. The method of claim 12, wherein the method further includes remotely activating the cartridge to release ethylene oxide gas.

14. The method of claim 6, wherein the method further comprises maintaining the temperature of ethylene oxide at about 45°

C. to about 55°

C.

15. The method of claim 6, further comprising a step of purging residual ethylene oxide gas from the diffusion bag for a sufficient time.

16. The method of claim 15, wherein the purging step duration is about 16 hours to 24 hours.

17. A method of sterilizing a brachytherapy device, the method comprising:

providing a gas permeable tray to contain said brachytherapy device;

wherein said brachytherapy device comprises a radioactive seed implant arranged in a delivery needle and a stylet arranged at least partially in the delivery needle so that a portion of the stylet extends out from the delivery needle;

securing the delivery needle to the tray and the portion of the stylet to the tray so as to resist relative movement of the stylet and the delivery needle;

placing said tray into a sealable diffusion bag;

sealing the diffusion bag;

positioning the diffusion bag in a chamber of a sterilizer having a ventilation system for removal of an exhaust gas from the chamber;

providing a sterilizing atmosphere in the interior of the diffusion bag by releasing into the diffusion bag ethylene oxide at a concentration sufficient to act as a sterilant;

heating the ethylene oxide to an appropriate temperature;

maintaining the temperature of the ethylene oxide gas for a sufficient time to sterilize the brachytherapy device and to complete the sterilization process;

conducting a performance qualification of the sterilization process through physical and microbiological studies;

extracting from the performance qualification a set of physical process parameters, which will consistently yield the desired sterility assurance level when said set of physical process parameters are maintained;

maintaining, monitoring, and recording the physical process parameters through direct analysis during routine processing; and

repeating the sterilization process for subsequent brachytherapy devices and releasing the sterilized brachytherapy devices on parametric release.

18. The method of claim 17, wherein one of said physical process parameters is a load configuration.

19. The method of claim 17, wherein one of said physical process parameters is a sterilization temperature.

20. The method of claim 17, wherein one of said physical process parameters is a pressure in said chamber of the sterilizer.

21. The method of claim 17, wherein one of said physical process parameters is a cycle time for sterilization and purging.

22. The method of claim 17, wherein one of said physical process parameters is a gas concentration profile.

23. The method of claim 17, wherein the sterility assurance level is 10⁻

6.

24. The method of claim 17, wherein the method includes selecting the diffusion bag to be constructed of a material that allows ethylene oxide outwardly to diffuse from the diffusion bag.

25. The method of claim 17, wherein the method includes selecting the diffusion bag to be constructed of a tear-resistant material.

26. The method of claim 17, wherein the method further includes selecting the diffusion bag to be constructed of low density polyethylene.

27. The method of claim 17, wherein the method includes selecting the diffusion bag to be hermetically-sealed to form a substantially leak-proof seal.

28. The method of claim 17, wherein the method includes releasing ethylene oxide into the diffusion bag by a delivery mechanism.

29. The method of claim 28, wherein the delivery mechanism is a cartridge containing ethylene oxide.

30. The method of claim 29, wherein the method further includes remotely activating the cartridge to release ethylene oxide gas.

31. The method of claim 17, further comprising maintaining the temperature of the ethylene oxide at about 45°

C. to about 55°

C.

32. The method of claim 17, further comprising a step of purging residual ethylene oxide gas from the diffusion bag for a sufficient time.

33. The method of claim 32, wherein the purging duration is about 16 to 24 hours.

34. A method of sterilizing a brachytherapy device, the method comprising:

receiving the brachytherapy device secured to a gas permeable tray, the brachytherapy device including a radioactive seed implant arranged in a delivery needle;

receiving a stylet for use with the brachytherapy device;

wherein the stylet is secured to the tray;

placing said tray into a sealable diffusion bag;

positioning the diffusion bag in a chamber of a sterilizer;

providing a sterilizing atmosphere in the interior of the diffusion bag by releasing ethylene oxide into the diffusion bag at a concentration sufficient to act as a sterilant;

sterilizing the brachytherapy device by controlling an environment of the chamber using a set of process parameters; and

parametrically releasing the at least one brachytherapy device from the sterilization process.

35. The method of claim 34, wherein:

the ethylene oxide is released into the diffusion bag by way of a cartridge containing ethylene oxide; and

the step of providing a sterilizing atmosphere further includes remotely activating the cartridge to release ethylene oxide gas.

36. The method of claim 34, further comprising after parametrically releasing the at least one brachytherapy device:

removing said tray from the diffusion bag;

placing said tray into a sterile pouch;

sealing said sterile pouch; and

placing said sterile pouch in a lead pouch to block radiation leakage.

37. The method of claim 34, further comprising:

pre-conditioning the environment of the chamber with air having a relative humidity within a range of 35-85% at a temperature within a range of 21-50°

C.; and

maintaining the relative humidity within a range of 35-85% while sterilizing;

wherein releasing ethylene oxide is maintained at a rate within a tolerance of +/−

5%.

38. The method of claim 34, further comprising:

receiving a series of brachytherapy devices corresponding to a treatment program, each brachytherapy device secured to the gas permeable tray, each brachytherapy device including a radioactive seed implant corresponding to a portion of the treatment program arranged in a corresponding delivery needle; and

receiving corresponding stylets for use with each of the brachytherapy devices;

wherein each stylet are secured to the tray.

39. The method of claim 34, wherein the stylet is received arranged at least partially in the delivery needle so that a portion of the stylet extends out from the delivery needle;

and

wherein the portion of the stylet is secured to the tray so as to resist relative movement of the stylet and the delivery needle.