Tissue processing apparatus and method

• US 9,308,296 B2
• Filed: 05/05/2014
• Issued: 04/12/2016
• Est. Priority Date: 05/05/2014
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Bhattacharyya, Subhabrata, Kaes, David R., Theiss, Brandon R.
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US14/269,287
• Publication Number:
  US 20150314043A1
• Time in Patent Office: 708 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

A tissue treatment apparatus and method for treating biologic tissue has a controller, an enclosure, a reagent supply system, a draining configuration, and a gas relief valve is controlled by the controller. Optionally provided is a gas evacuation assembly, a gas supply unit, a thermal unit for heating or cooling reagents or gases, a sonication unit, any or each operated by the controller. The method provides for programming controller to effect a treatment procedure. In an embodiment of the present application the tissue sample is bone material and the treatment procedure effects demineralization of the bone material.

Claims

1. An apparatus for processing a biologic tissue sample, the apparatus comprising:

a controller;

an enclosure defining a reaction chamber for accepting the tissue sample, the tissue sample comprising bone material;

a reagent supply system configured to receive at least one reagent and to dispense said at least one reagent into said reaction chamber in response to said controller;

a gas evacuation assembly communicated to said reaction chamber and configured to pump gas from said reaction chamber in response to said controller;

a draining assembly communicated to said reaction chamber and configured to drain fluid from said reaction chamber in response to said controller; and

a signal transmission system functionally interconnecting said controller with said reagent supply system, said gas evacuation assembly, and said draining assembly,

wherein the controller comprises computer readable instructions to cause the controller to effect evacuation of said reaction chamber to a predetermined pressure level by activating said gas evacuation assembly to evacuate gas from said reaction chamber when said at least one reagent is dispensed into the reaction chamber.

2. An apparatus of claim 1, further comprising a fluid level detector disposed to detect a fluid level in said reaction chamber and communicate said fluid level to said controller via said signal transmission system.

3. An apparatus of claim 1, further comprising a gas pressure detector disposed to detect a gas pressure in said reaction chamber and communicate said gas pressure to said controller via said signal transmission system and the tissue sample comprises bone tissue that is demineralized with the reagent that comprises an acid in the chamber.

4. An apparatus of claim 1, further comprising a carbon dioxide sensor communicated to said reaction chamber to detect a carbon dioxide level in said reaction chamber and communicate said carbon dioxide level to said controller via said signal transmission system and the tissue sample comprises bone tissue that is demineralized with the reagent that comprises an acid in the chamber and the porosity of the demineralized bone tissue is controlled.

5. An apparatus of claim 1, further comprising a gas supply unit communicated to said reaction chamber and configured to receive at least one gas and dispense said at least one gas into said reaction chamber in response to said controller, said gas supply unit being functionally interconnected with said controller via said signal transmission system and the tissue sample comprises bone tissue that is demineralized by controlled soaking with the reagent that comprises an acid in the chamber.

6. An apparatus of claim 5, further comprising a thermal assembly configured to effect at least one of heating or cooling of at least one of said at least one reagent, said at least one gas, or contents of said reaction chamber, wherein said thermal assembly is controlled by said controller and the tissue sample comprises bone tissue that is demineralized with the reagent that comprises an acid in the chamber, wherein gases generated from the demineralization of bone is removed from the chamber.

7. An apparatus of claim 6, further comprising a sonication unit configured to effect sonication of contents of said reaction chamber, wherein said sonication unit is controlled by said controller.

8. An apparatus of claim 1, further comprising a thermal assembly configured to effect at least one of heating or cooling of at least one of said at least one reagent, or contents of said reaction chamber, wherein said thermal assembly is controlled by said controller.

9. An apparatus of claim 1, further comprising a sonication unit configured to effect sonication of contents of said reaction chamber, wherein said sonication unit is controlled by said controller.

10. A method for treating biologic tissue sample, comprising:

providing;

a controller;

an enclosure defining a reaction chamber for accepting the tissue sample;

a reagent supply system configured to receive at least one reagent and to dispense said at least one reagent into said reaction chamber in response to said controller;

a gas evacuation assembly communicated to said reaction chamber and configured to pump gas from said reaction chamber in response to said controller;

a draining assembly communicated to said reaction chamber and configured to drain fluid from said reaction chamber in response to said controller; and

a signal transmission system functionally interconnecting said controller with said reagent supply system, said gas evacuation assembly, and said draining assembly;

loading said controller with a treatment procedure programming for effecting a treatment procedure;

loading said reagent supply system with a first reagent;

disposing said biologic tissue sample in said reaction chamber;

effecting application of said first reagent to said biologic tissue sample by said controller activating said reagent supply system to dispense a predetermined amount of said first reagent into said reaction chamber in accordance with said treatment procedure programming;

effecting draining of said first reagent from said reaction chamber by said controller activating said draining assembly to drain said first reagent from said reaction chamber, after a predetermined time period has passed since said application of said first reagent to said biologic tissue sample, in accordance with said treatment procedure programming; and

effecting evacuation of said reaction chamber to a predetermined pressure level by said controller activating said gas evacuation assembly to evacuate gas from said reaction chamber during said application of said first reagent to said biologic tissue sample in accordance with said treatment procedure programming.

11. A method of claim 10, further comprising:

providing a carbon dioxide sensor communicated to said reaction chamber to detect a carbon dioxide level in said reaction chamber and communicate said carbon dioxide level to said controller via said signal transmission system; and

maintaining a CO2 level in said reaction chamber below a predetermined CO2 level during said application of said first reagent to said biologic tissue sample by said controller monitoring said CO2 level in said reaction chamber and activating said gas evacuation assembly in response to said CO2 level rising above said predetermined CO2 level to bring said CO2 level to or below said predetermined CO2 level in accordance with said treatment procedure programming, wherein said biologic tissue sample is bone material and said first reagent is an acid suitable for demineralizing said bone material.

12. A method of claim 11, further comprising:

loading said reagent supply system with a second reagent;

effecting application of said second reagent to said biologic tissue sample by said controller activating said reagent supply system to dispense a predetermined amount of said second reagent into said reaction chamber in accordance with said treatment procedure programming; and

effecting draining of said second reagent from said reaction chamber by said controller activating said draining assembly to drain said second reagent from said reaction chamber, after a predetermined time period has passed since said application of said second reagent to said biologic tissue sample, in accordance with said treatment procedure programming, wherein said second reagent is water.

13. A method of claim 12, further comprising:

loading said reagent supply system with a third reagent;

effecting application of said third reagent to said biologic tissue sample by said controller activating said reagent supply system to dispense a predetermined amount of said third reagent into said reaction chamber in accordance with said treatment procedure programming; and

effecting draining of said third reagent from said reaction chamber by said controller activating said draining assembly to drain said third reagent from said reaction chamber, after a predetermined time period has passed since said application of said third reagent to said biologic tissue sample, in accordance with said treatment procedure programming, wherein said third reagent is an alcohol suitable for delipidizing said bone material.

14. A method of claim 13, further comprising:

loading said reagent supply system with a fourth reagent;

effecting application of said fourth reagent to said biologic tissue sample by said controller activating said reagent supply system to dispense a predetermined amount of said fourth reagent into said reaction chamber in accordance with said treatment procedure programming; and

effecting draining of said fourth reagent from said reaction chamber by said controller activating said draining assembly to drain said fourth reagent from said reaction chamber, after a predetermined time period has passed since said application of said fourth reagent to said biologic tissue sample, in accordance with said treatment procedure programming, wherein said fourth reagent is chemical chaperone suitable for at least partially reversing or preventing denaturation of proteins of said bone material.

15. A method of claim 14, wherein said fourth reagent is glycerol.

16. A method of claim 10, further comprising:

providing a thermal assembly configured to effect at least one of heating or cooling of at least one of said first reagent or contents of said reaction chamber, wherein said thermal assembly is controlled by said controller; and

effecting heating of said first reagent to a predetermine temperature by said thermal assembly in response to control thereof by said controller such that said first reagent is at said predetermined temperature when in contact with the tissue sample in said enclosure in accordance with said treatment procedure programming, wherein said biologic tissue sample is bone material, said first reagent is an acid suitable for demineralizing said bone material, and said predetermined temperature is in the range of 40 degrees Celsius to 120 degrees Celsius.

17. A method of claim 10, further comprising:

providing a gas supply unit communicated to said reaction chamber and configured to receive at least one gas and dispense said at least one gas into said reaction chamber in response to said controller, said gas supply unit being functionally interconnected with said controller via said signal transmission system;

providing a thermal assembly configured to effect at least one of heating or cooling of at least one of said first reagent or contents of said reaction chamber, wherein said thermal assembly is controlled by said controller;

effecting evacuation of said enclosure by said gas evacuation assembly in response to control thereof by said controller in accordance with said treatment procedure programming;

effecting charging of said enclosure with said at least one gas by operation of said gas supply unit in response to control thereof by said controller in accordance with said treatment procedure programming; and

effecting heating of said at least one gas to a predetermine temperature by said thermal assembly in response to control thereof by said controller such that said at least one gas is at said predetermined temperature when in contact with the tissue sample in said enclosure in accordance with said treatment procedure programming, wherein said biologic tissue sample is bone material, said at least one gas is not oxygen, and said predetermined temperature is in the range of 40 degrees Celsius to 120 degrees Celsius.

18. A method of claim 10, wherein said at least one gas is supercritical carbon dioxide and said controller is programmed to adjust pressure of said supercritical carbon dioxide to adjust properties thereof between gas properties and liquid properties to vary solvent action thereof.

19. A method of claim 10, further comprising:

providing a sonication unit configured to effect sonication of contents of said reaction chamber, wherein said sonication unit is controlled by said controller; and

effecting sonication of said first reagent by said sonication unit in response to control thereof by said controller such that said first reagent is sonicated at a predetermined level when in contact with the tissue sample in said enclosure in accordance with said treatment procedure programming, wherein said biologic tissue sample is bone material, said first reagent is an acid suitable for demineralizing said bone material.