US2021009936A1PendingUtilityA1

Fluid Pumping and Bioreactor System

Assignee: DEKA PRODUCTS LPPriority: Oct 9, 2015Filed: Sep 22, 2020Published: Jan 14, 2021
Est. expiryOct 9, 2035(~9.2 yrs left)· nominal 20-yr term from priority
C12M 25/14A61L 27/38C12M 23/40C12M 23/42C12M 41/48C12M 21/08C12M 29/00A61L 27/3683C12N 5/0602
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Claims

Abstract

A fluid pumping and bioreactor system including at least two cassettes, at least one storage reservoir, at least one bioreactor, at least one manifold including valve modules, and tubing to connect the cassettes to the storage reservoir and the bioreactor. The cassettes can include pumps, valves, and fluid conduits and can be communicatively connected to the at least one manifold. The bioreactor can include an adapter and fluid conduits extending through the adapter from the exterior of the bioreactor to the interior of the bioreactor. System and method for generating a tissue for transplant by decellularizing and recellularizing a supplied tissue.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for engineering a transplantable tissue from a donor tissue comprising:
 accessing a recipe including recipe steps;   receiving GUI input from a graphical user interface (GUI); and   accessing, by a controller, the recipe steps, the GUI input, and at least one default value;   forming, by the controller, at least one controller command based on arbitrating the at least one default value, the recipe steps, and the GUI input;   executing, by the controller, the at least one controller command to engineer the transplantable tissue including the donor tissue.   
     
     
         2 . The method as in  claim 1  further comprising:
 updating, by the controller, the GUI based at least on a status of the transplantable tissue; and 
 updating, by the controller, the recipe based at least on the status. 
 
     
     
         3 . The method as in  claim 1  comprising:
 configuring at least one valve in a fluid path according to the recipe; 
 continually adjusting the fluid path by manipulating the at least one valve based on the recipe; 
 pumping water through the continually-adjusted fluid path past at least one of the at least one valve to a mix cassette, an amount of the water being based on the recipe; 
 pumping at least one solution through the continually-adjusted fluid path past at least one of the at least one valve to the mix cassette, a solution amount of the at least one solution being based at least on the recipe; 
 mixing the water and the at least one solution in the mix cassette to form a medium, a mixing amount of the mixing being based at least on the recipe; 
 pumping the medium through the continually-adjusted fluid path to a reservoir based at least on the recipe; 
 pumping the medium through the continually-adjusted fluid path from the reservoir to a bioreactor based at least on the recipe, the medium becoming a used medium in the bioreactor; and 
 pumping the used medium through the continually-adjusted fluid path from the bioreactor to a drain based at least on the recipe. 
 
     
     
         4 . The method as in  claim 1  wherein the water comprises deionized water. 
     
     
         5 . The method as in  claim 1  further comprising:
 filtering the water; 
 deaerating the water; and 
 if a water amount of the water exceeds a pre-selected threshold, storing at least part of the water. 
 
     
     
         6 . The method as in  claim 3  wherein the at least one solution comprises a concentrated form of the at least one solution. 
     
     
         7 . The method as in  claim 1  comprising:
 covering at least one pumping chamber and at least one fluid valve of at least one cassette with a flexible sheet; 
 housing the donor tissue in a bioreactor, the bioreactor being in fluid communication with the at least one cassette; 
 receiving, by at least one module processor, the at least one controller command from the controller; 
 generating, by the at least one module processor, at least one module command based on the at least one controller command, the at least one module command being addressed to at least one module; 
 receiving, by the at least one module, the at least one module command; 
 generating, by the at least one module, a plurality of valve commands based on the at least one module command, the plurality of valve commands governing fluid flow through a plurality of valves of the at least one module, the at least one fluid valve controlling pressure applied to the flexible sheet via outlet ports; and 
 decellularizing the donor tissue using the fluid flow metered based on the at least one controller command. 
 
     
     
         8 . The method as in  claim 7  wherein the at least one cassette comprises a pneumatically controlled cassette. 
     
     
         9 . The method as in  claim 7  wherein at least one of the at least one cassette comprises a disposable cassette. 
     
     
         10 . The method as in  claim 1  further comprising:
 iteratively decellularizing and recellularizing the donor tissue until the transplantable tissue is generated. 
 
     
     
         11 . The method as in  claim 10  further comprising:
 applying a first protocol to the decellularizing; and 
 applying a second protocol to recellularizing. 
 
     
     
         12 . The method as in  claim 10  further comprising:
 introducing the donor tissue to at least one agent for a pre-selected amount of time; and 
 introducing a cell culture to the donor tissue. 
 
     
     
         13 . The method as in  claim 10  wherein decellularizing the donor tissue comprises:
 configuring at least one valve in a fluid path according to a recipe; 
 continually adjusting the fluid path by manipulating the at least one valve based on the recipe; 
 pumping water through the continually-adjusted fluid path past at least one of the at least one valve to a mix cassette, the amount of the water being based on the recipe; 
 pumping at least one solution through the continually-adjusted fluid path past at least one of the at least one valve to the mix cassette, the amount of the at least one solution being based on the recipe; 
 mixing the water and the at least one solution in the mix cassette to form a medium, the amount of the mixing being based on the recipe; 
 pumping the medium through the continually-adjusted fluid path to a reservoir based on the recipe; 
 pumping the medium through the continually-adjusted fluid path from the reservoir to a bioreactor based on the recipe, the medium becoming a used medium in the bioreactor; and 
 pumping the used medium through the continually-adjusted fluid path from the bioreactor to a drain based on the recipe. 
 
     
     
         14 . A method for engineering a tissue comprising:
 covering at least one pumping chamber and at least one fluid valve of at least one cassette with a flexible sheet;   housing the tissue in a bioreactor, the bioreactor being in fluid communication with the at least one cassette;   receiving, by at least one module processor, at least one controller command from a controller;   generating, by the at least one module processor, at least one module command based on the controller command, the at least one module command being addressed to at least one module;   receiving, by the at least one module, the at least one module command;   generating, by the at least one module, a plurality of valve commands based on the at least one module command, the plurality of valve commands governing fluid flow through a plurality of valves of the at least one module, the at least one fluid valve controlling pressure applied to the flexible sheet via the outlet ports;   decellularizing the tissue using the fluid flow metered based on the at least one controller command; and   recellularizing the decellularized tissue.   
     
     
         15 . The method as in  claim 14  wherein the plurality of pumping cassettes comprise pneumatically controlled cassettes. 
     
     
         16 . The method as in  claim 14  wherein at least one of mixing cassette and the plurality of pumping cassettes comprise disposable cassettes. 
     
     
         17 . The method as in  claim 14  wherein the water comprises deionized water. 
     
     
         18 . The method as in  claim 14  further comprising:
 filtering the water; 
 deaerating the water; and 
 if the amount of the water exceeds a pre-selected threshold, storing at least part of the water. 
 
     
     
         19 . The method as in  claim 14  wherein the at least one solution is concentrated. 
     
     
         20 . A method for generating a tissue for transplant comprising:
 iteratively decellularizing and recellularizing a biological specimen until the tissue is generated.   
     
     
         21 . The method as in  claim 20  further comprising:
 applying a first protocol to the decellularizing; and 
 applying a second protocol to recellularizing. 
 
     
     
         22 . The method as in  claim 20  further comprising:
 introducing the biological specimen to at least one agent for a pre-selected amount of time; and 
 introducing a cell culture to the biological specimen.

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