Apparatus and 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description will be more fully understood in view of the drawings in which:

FIG. 1 is a schematic illustration of a treatment system according to one embodiment of the present invention;

FIG. 2 is a schematic illustration of a treatment system according to another embodiment of the present invention;

FIG. 3 is a schematic illustration of a treatment canister according to one embodiment of the present invention;

FIG. 4 is a schematic illustration of a treatment canister according to another embodiment of the present invention;

FIG. 5 is a schematic illustration of a treatment system according to another embodiment of the present invention;

FIG. 6 is a schematic illustration of a treatment system according to yet another embodiment of the present invention;

FIG. 7 is a schematic illustration of a treatment system according to one embodiment of the present invention.

Claims

1. An apparatus for treating allografts, comprising: (a) a sonication tank configured to transmit ultrasonic energy to the interior of the tank;(b) a treatment canister rotatably positioned in said sonication tank, and configured to receive allografts therein; and(c) a treatment fluid source in fluid communication with said treatment canister.

2. The apparatus of claim 1, wherein said treatment canister is foraminous such that fluid within said sonication tank will pass into said treatment canister.

3. The apparatus of claim 1, wherein said sonication tank contains a sonication fluid and said treatment canister is sealed with respect to said sonication tank such that said sonication fluid cannot enter the interior of said treatment canister.

4. The apparatus of claim 1, further comprising a motor for rotating said treatment canister within said sonication tank.

5. The apparatus of claim 1, further comprising a plurality of treatment fluid sources in selective fluid communication with the interior of said cleaning canister.

6. The apparatus of claim 1, further comprising a fluid control system adapted for exchanging treatment fluid in said treatment canister without removing the allografts from the treatment canister.

7. The apparatus of claim 6, wherein said apparatus includes at least first and second treatment fluid sources, and said control system is adapted for delivering the first treatment fluid to said treatment canister and for replacing the first treatment fluid in said treatment canister with the second treatment fluid.

8. The apparatus of claim 1, wherein the treatment canister comprises at least four canisters for the processing of up to 4 different donors at once and can be configured for more donors at a time.

9. The apparatus of claim 1, further comprising a treatment fluid outlet in fluid communication with said treatment canister and a filter in selective fluid communication with said treatment fluid outlet.

10. The apparatus 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.

11. The apparatus of claim 1, further comprising a temperature controller configured to control temperature of the sonication fluid.

12. The apparatus of claim 1, further comprising a programmable logic controller in communication with the sonication tank and configured to control the amount of ultrasonic energy transmitted to the interior of the tank.

13. The apparatus of claim 1, wherein the treatment fluid has a ratio ranging from about 1:5 to about 1:2 of solution (ml) to tissue (g).

14. The apparatus of claim 1, wherein the treatment fluid has a ratio of about 1:2 of solution (ml) to tissue (g).

15. The apparatus of claim 1, wherein the canister comprises one or more internal baffles.

16. The apparatus of claim 1, wherein the canister comprises one or more grooves or ribs on an inner surface of the canister.

17. 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, andat 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 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.

18. The method of claim 17, wherein said treatment canister is foraminous.

19. The method of claim 17, wherein said cleaning canister is sealed with respect to said sonication tank, and a sonication fluid is provided in said tank.

20. The method of claim 17, 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.

21. The method of claim 17, 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.

22. The method of claim 17, 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.

23. The method of claim 17, wherein the allografts are sonicated at a temperature of between about 20° C. and about 50° C.

24. The method of claim 17, wherein the allografts are sonicated at a temperature of between about 45° C. and about 50° C.

25. The method of claim 17, 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.

26. The method of claim 17, 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.

27. The method of claim 26, wherein said ultrasonic treatment apparatus further includes a fluid control system adapted for exchanging said first treatment fluid for said second treatment fluid.

28. The method of claim 26, 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.

29. The method of claim 26, 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.

30. The method of claim 17, 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.

31. The method of claim 17, further comprising the step of removing said treatment fluid from the treatment canister and filtering at least a portion of the removed treatment fluid.

32. The method of claim 17, further comprising the steps of: providing an extraction fluid in said treatment canister;applying ultrasonic energy to said allografts while rotating said treatment canister; andanalyzing the extraction fluid for microbial contamination.

33. The method of claim 17, 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.

34. The method of claim 17, 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.

35. A method of treating allografts, comprising: (a) providing an ultrasonic treatment apparatus, said treatment apparatus including a treatment canister, andat 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 a treatment fluid in said treatment canister; and(d) applying ultrasonic energy to said allografts while rotating said allografts.

36. The method of claim 35, wherein said allografts are rotated by rotating said treatment canister.

37. The method of claim 35, wherein said allografts are rotated by the flow of treatment fluid within said treatment canister.

38. The method of claim 35, wherein the canister is rotated at a rate from of from about 0.1 to about 60 revolutions per minute (rpm).

39. The method of claim 35, wherein the canister is rotated at a rate from of from about 8 to about 12 revolutions per minute (rpm).

40. The method of claim 35, wherein the canister is rotated at a rate from of about 10 revolutions per minute (rpm).

41. (canceled)