Electron-beam sterilization of biological materials

• US 5,989,498 A
• Filed: 10/21/1996
• Issued: 11/23/1999
• Est. Priority Date: 03/04/1994
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Odland, Thomas L.
• Primary Examiner(s): MCKANE, ELIZABETH L
• Application Number:
  US08/734,494
• Time in Patent Office: 1,128 Days
• Field of Search: 422/22, 422/23, 422/28, 422/36, 435/1.1, 250/455.11, 623/2
• US Class Current: 422/22
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/007 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: Y10S 623/918 Heart

Abstract

A method for sterilizing collagen containing tissue includes crosslinking the tissue to form a crosslinked biological tissue. The tissue is maintained in a hydrated state. The crosslinked, collagen-containing tissue is sterilized by irradiating the tissue with a beam of accelerated electrons. The biological tissue exposed to accelerated electrons is suitable for surgical implantation. The irradiated biological tissue is not significantly degraded following irradiation. The irradiation can be performed on tissue that has been packed in a container in a hydrated state.

Claims

1. A method for sterilizing a collagen-containing biological tissue comprising the steps of:

crosslinking said biological tissue to form a crosslinked biological tissue;

maintaining said crosslinked biological tissue in a hydrated state; and

irradiating said crosslinked, collagen-containing biological tissue with a beam of accelerated electrons, wherein said biological tissue exposed to accelerated electrons is suitable for surgical implantation and said irradiated biological tissue is not significantly degraded following said irradiation of said crosslinked biological tissue.

2. The method of claim 1 wherein irradiating a biological tissue comprises irradiating a heart valve, vascular prosthesis, or pericardial patch.

3. The method of claim 1 wherein irradiating a biological tissue with a beam of accelerated electrons comprises directly exposing the biological tissue to a beam of accelerated electrons, wherein the dose of accelerated electrons on an upper and lower surface of the biological tissues is approximately equal.

4. The method of claim 1 wherein irradiating a biological tissue with a beam of accelerated electrons comprises controlling the maximum to minimum dose ratio.

5. The method of claim 1 wherein irradiating a biological tissue with a beam of accelerated electrons comprises controlling build-up of electrons within the biological tissue.

6. The method of claim 1 wherein the irradiated biological tissue has long term durability as determined with an accelerated wear tester on average at least comparable to the tissue'"'"'s durability without irradiation.

7. The method of claim 1, wherein said irradiated biological tissue has a shrink temperature on average greater than a temperature about 7°

below the shrink temperature of the biological tissue without irradiation.

8. The method of claim 1 wherein said tissue is crosslinked with glutaraldehyde.

9. The method of claim 1 wherein said tissue is a heart valve, a vascular prosthesis, or a pericardial patch.

10. The method of claim 1 further comprising maintaining said tissue in an unfrozen state.

11. A method for preparing a biological tissue for implantation comprising:

packaging a crosslinked, biological tissue in a container in a hydrated state; and

terminally sterilizing the packaged biological tissue by exposing the packaged biological tissue to a beam of accelerated electrons, wherein the biological tissue exposed to accelerated electrons is suitable for surgical implantation and the irradiated biological tissue is not significantly degraded following said irradiation of said crosslinked biological tissue.

12. The method of claim 11 further comprising exposing the biological tissue to at least one anticalcification agent prior to packaging.

13. The method of claim 11 wherein packaging comprises adding a peroxide scavenger to the biological tissue prior to sterilizing the biological tissue.

14. The method of claim 11 wherein terminally sterilizing the packaged biological tissue includes terminally sterilizing the package and the biological tissue.

15. The method of claim 11 wherein packaging comprises adding at least one of the group consisting of a peroxide scavenger, a radioprotectant, and a buffer to the biological tissue prior to sterilizing the biological tissue.

16. The method of claim 11, wherein said irradiated biological tissue has long term durability as determined with an accelerated wear tester on average at least comparable to the tissue'"'"'s durability without irradiation.

17. The method of claim 11, wherein said irradiated biological tissue has a shrink temperature on average greater than a temperature about 7°

below the shrink temperature of the biological tissue without irradiation.

18. A method for sterilizing a biological tissue prior to implantation comprising:

exposing a biological tissue to at least one crosslinking agent to produce a crosslinked biological tissue;

adding an anticalcification agent in a buffer to the crosslinked biological tissue;

rinsing the biological tissue treated according to the previous two steps, to form a rinsed biological tissue;

packaging the rinsed biological tissue in a container in a hydrated state; and

irradiating the package and the biological tissue with a beam of accelerated electrons, wherein the irradiated biological tissue is not significantly degraded following said irradiation of said crosslinked biological tissue.

19. The method of claim 18, wherein said irradiated biological tissue has long term durability as determined with an accelerated wear tester on average at least comparable to the tissue'"'"'s durability without irradiation.

20. The method of claim 18, wherein said irradiated biological tissue has a shrink temperature on average greater than a temperature about 7°

below the shrink temperature of the biological tissue without irradiation.