US 12,227,727 B2
Medical devices and uses thereof
Randice Lisa Altschul, Cliffside Park, NJ (US); Neil David Theise, New York, NY (US); Razvan Andrei Ene, Vimercate (IT); Myron Rapkin, Indianapolis, IN (US); and Rebecca O'Brien, Shell Knob, MO (US)
Assigned to Pop Test Oncology LLC, Cliffside Park, NJ (US)
Appl. No. 16/992,705
Filed by Pop Test Oncology LLC, Cliffside Park, NJ (US)
PCT Filed Feb. 27, 2019, PCT No. PCT/US2019/019744
§ 371(c)(1), (2) Date Aug. 13, 2020,
PCT Pub. No. WO2019/168913, PCT Pub. Date Sep. 6, 2019.
Claims priority of provisional application 62/723,071, filed on Aug. 27, 2018.
Claims priority of provisional application 62/655,367, filed on Apr. 10, 2018.
Claims priority of provisional application 62/650,165, filed on Mar. 29, 2018.
Claims priority of provisional application 62/636,196, filed on Feb. 28, 2018.
Prior Publication US 2021/0162125 A1, Jun. 3, 2021
Int. Cl. A61M 5/142 (2006.01); A61B 5/00 (2006.01); A61B 5/145 (2006.01); A61M 1/16 (2006.01); A61M 1/34 (2006.01); A61M 1/36 (2006.01); C12M 1/00 (2006.01); C12M 1/12 (2006.01); C12M 3/00 (2006.01); C12M 3/06 (2006.01); G01N 33/574 (2006.01); A61B 5/021 (2006.01); A61B 34/20 (2016.01)
CPC C12M 23/42 (2013.01) [A61B 5/14546 (2013.01); A61B 5/4845 (2013.01); A61B 5/4866 (2013.01); A61M 1/3486 (2014.02); A61M 1/3489 (2014.02); A61M 1/3623 (2022.05); A61M 5/14244 (2013.01); A61M 5/14276 (2013.01); C12M 3/065 (2013.01); C12M 3/067 (2013.01); C12M 23/44 (2013.01); C12M 23/58 (2013.01); C12M 25/14 (2013.01); G01N 33/57438 (2013.01); A61B 5/021 (2013.01); A61B 2034/2055 (2016.02); A61M 1/1601 (2014.02); A61M 2202/0413 (2013.01); A61M 2202/0415 (2013.01); A61M 2205/18 (2013.01); A61M 2205/3584 (2013.01); A61M 2205/50 (2013.01); A61M 2210/1071 (2013.01); A61M 2210/1082 (2013.01); C12M 3/06 (2013.01)] 4 Claims
OG exemplary drawing
 
1. A bio-artificial organ device for processing of a biological fluid for the production of a biologically active, physiologically sustainable tissue comprising:
an inflow port for ingress of a biological fluid;
a distribution chamber which optionally includes a pump;
at least one column in fluid communication with the distribution chamber having a cap wherein said at least one column can receive biological fluid flow from the inflow port, wherein said at least one column comprises a decellularized, de-vitalized extracellular matrix derived from a non-micro organ source selected from the group consisting of either neonatal porcine or human liver, adult porcine or human liver, neonate porcine or human pancreas, adult porcine or human pancreas, and combinations thereof, further wherein said at least one column comprises a living cellular component selected from the group consisting of hepatocytes, hepatobiliary progenitor cells, hepatobiliary stem cells, pancreatic islet beta cells, pancreatic stem cells, and combinations thereof;
wherein said column has one or more sensors that monitor said column for metabolic and functional activity;
wherein when there are more than one column, the columns are independent from each other;
a holding device surrounding an entirety of an axial surface of the at least one column and configured so as to allow insertion into the holding device and removal from the holding device of the at least one column, and wherein the at least one column is attached to the distribution cap with a column connector;
a sealingly closeable outer casing;
a thermal control system including a thermos-pouch encasing the bio-artificial organ which maintains the device at an optimal temperature for the cells within the device;
the function of the bio-artificial organ may be controlled by control units selected from the group consisting of dedicated sensors, micro-controllers, wireless communication systems, micro actuators, contactless identification tags and combinations thereof;
an outflow port for egress of a biological fluid,
wherein said bio-artificial organ conducts and processes said biological fluid; and
the device is adapted to hold approximately 500-700 grams of cellularized tissue in order to provide sufficient tissue function to keep the body in homeostasis.