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Last Updated: March 29, 2024

Claims for Patent: 7,794,653


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Summary for Patent: 7,794,653
Title:Methods for treating allograft products
Abstract: Apparatus for treating allografts, having a sonication tank configured to transmit ultrasonic energy to the interior of the tank; a treatment canister rotatably positioned in said sonication tank, and configured to receive allografts therein; and a treatment fluid source in fluid communication with said treatment canister. Methods of treating allografts and methods for determining microbial contamination using the apparatus.
Inventor(s): Ronholdt; Chad J. (Aurora, CO), Bogdansky; Simon (Littleton, CO), Hooks; Alan (Commerce City, CO)
Assignee: Allosource (Centennial, CO)
Application Number:12/034,150
Patent Claims:1. A method of treating allografts, comprising: (a) providing an ultrasonic treatment apparatus, said treatment apparatus including a sonication tank, a treatment canister rotatably mountable in said sonication tank, a treatment fluid source having a line in fluid communication with, and rotatably coupled to, said treatment canister, said treatment fluid source configured to supply at least one treatment fluid to the interior of said treatment canister supported by said sonication tank, and said line rotatably coupled with said treatment canister configured to allow simultaneous rotation of said treatment canister and exchange of the at least one treatment fluid with said treatment canister while said treatment canister remains in fluid communication with the fluid source, and at least one ultrasonic transducer configured to transmit ultrasonic energy to the interior of said tank and said treatment canister; (b) placing one or more allografts inside said treatment canister; (c) exposing said allografts to the at least one treatment fluid in said treatment canister while applying ultrasonic energy to said allografts and rotating said treatment canister in said sonication tank.

2. The method of claim 1, wherein said treatment canister is foraminous.

3. The method of claim 1, wherein said treatment canister is sealed with respect to said sonication tank, and a sonication fluid is provided in said tank.

4. The method of claim 1, wherein ultrasonic energy is applied to the allografts at a frequency between about 40 kHz and about 170 kHz with a power output of between about 100 watts/gallon and about 550 watts/gallon.

5. The method of claim 1, wherein rotating said treatment canisters in said sonication tank is configured to eliminate a shielding effect by exposing the entire allograft surface to ultrasonic energy and treatment fluid.

6. The method of claim 1, wherein ultrasonic energy is applied to the allografts at a frequency between about 72 kHz and about 104 kHz with a power output of between about 100 watts/gallon and about 300 watts/gallon.

7. The method of claim 1, wherein the allografts are sonicated at a temperature of between about 20.degree. C. and about 50.degree. C.

8. The method of claim 1, wherein the allografts are sonicated at a temperature of between about 45.degree. C. and about 50.degree. C.

9. The method of claim 1, wherein said step of exposing said allografts to at least one treatment fluid comprises providing a treatment fluid within said treatment canister, and further comprising the step of exchanging at least a portion of said treatment fluid in said treatment canister without removing the allografts from the treatment canister.

10. The method of claim 1, wherein said allografts are exposed to first and second treatment fluids, and further wherein said first treatment fluid is initially provided in said treatment canister and is thereafter exchanged for said second treatment fluid in said treatment canister.

11. The method of claim 10, wherein said ultrasonic treatment apparatus further includes a fluid control system adapted for exchanging said first treatment fluid for said second treatment fluid.

12. The method of claim 10, wherein said step of exchanging said first treatment fluid for said second treatment fluid comprises removing said first treatment fluid from the treatment canister, flushing the treatment canister with water, and thereafter delivering said second treatment fluid to the treatment canister.

13. The method of claim 10, wherein said first and second treatment fluids are chosen from the group consisting of: detergents, enzyme solutions, antibiotic solutions, oxidizing agents, alcohols, sterile water, and mixtures of the foregoing.

14. The method of claim 1, wherein said treatment canister has a rotational axis, and the interior of said treatment canister has a non-circular cross-sectional shape in a plane orthogonal to said rotational axis.

15. The method of claim 1, further comprising the step of removing said treatment fluid from the treatment canister and filtering at least a portion of the removed treatment fluid.

16. The method of claim 1, further comprising the steps of: providing an extraction fluid in said treatment canister; applying ultrasonic energy to said allografts while rotating said treatment canister; and simanalyzing the extraction fluid for microbial contamination.

17. The method of claim 1, after exposing said allografts to at least one treatment fluid in said treatment canister, removing said treatment canister from said sonication tank, transferring said treatment canister to an aseptic packaging site, removing said allografts from said treatment canister, and aseptically packaging said allografts.

18. The method of claim 1, wherein during said step of exposing said allografts to at least one treatment fluid in said treatment canister while applying ultrasonic energy to said allografts and rotating said treatment canister in said sonication tank, the frequency and/or intensity of ultrasonic energy is varied.

19. A method of treating allografts, comprising: (a) providing an ultrasonic treatment apparatus, said treatment apparatus including a sonication tank, a treatment canister, a treatment fluid source having a line in fluid communication with, and rotatably coupled to, said treatment canister, said treatment fluid source configured to supply at least one treatment fluid to the interior of said treatment canister supported by said sonication tank, and said line rotatably coupled with said treatment canister configured to allow simultaneous rotation of said treatment canister and exchange of the at least one treatment fluid with said treatment canister while said treatment canister remains in fluid communication with said fluid source, and at least one ultrasonic transducer configured to transmit ultrasonic energy to said treatment canister; (b) placing one or more allografts inside said treatment canister; (c) providing the at least one treatment fluid in said treatment canister; and (d) applying ultrasonic energy to said allografts while rotating said allografts.

20. The method of claim 19, wherein said allografts are rotated by rotating said treatment canister.

21. The method of claim 19, wherein said allografts are rotated by the flow of treatment fluid within said treatment canister.

22. The method of claim 19, wherein the canister is rotated at a rate from of from about 0.1 to about 60 revolutions per minute (rpm).

23. The method of claim 19, wherein the canister is rotated at a rate from of from about 8 to about 12 revolutions per minute (rpm).

24. The method of claim 19, wherein the canister is rotated at a rate from of about 10 revolutions per minute (rpm).

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