Giner, Inc.

Giner Life Sciences, Inc.

Giner Electrochemical Systems, LLC

Simon G Stone

Linda A Tempelman

Klearchos K Papas

Anthony A Ferrante

Cecelia C Cropley

Melissa Schwenk

William Earl Scott, Iii

Thomas M Suszynski

Shuichiro Matsumoto

Joana Ferrer Fabrega

Michael D Rizzari

Melissa N Schwenk

Method and system for controlling oxygen delivery to a cell implant. In one embodiment, the system includes a water electrolyzer, a cell capsule, a gas conduit, a total fluid pressure sensor, and a controller. The water electrolyzer generates gaseous oxygen with a variable output. The cell capsule includes a cell chamber adapted to hold cells. The gas conduit interconnects the water electrolyzer and the cell capsule to deliver gaseous oxygen generated by the water electrolyzer to the cell capsule. The total fluid pressure sensor is positioned at a location that provides a representative reading of the total fluid pressure within the cell chamber. The controller is electrically coupled both to the total fluid pressure sensor and to the water electrolyzer so that the controller may control the variable output of the water electrolyzer based on one or more sensed total pressure readings from the total fluid pressure sensor.

System and method for controlling oxygen delivery to implanted cells

System for gas treatment of cellular implants. The system enhances the viability and function of cellular implants, particularly those with high cellular density, for use in human or veterinary medicine. The system utilizes a miniaturized electrochemical gas generator subsystem that continuously supplies oxygen and/or hydrogen to cells within an implantable and immunoisolated cell containment subsystem to facilitate cell viability and function at high cellular density while minimizing overall implant size. The cell containment subsystem is equipped with features to allow gas delivery through porous tubing or gas-only permeable internal gas compartments within the implantable cell containment subsystem. Furthermore, the gas generator subsystem includes components that allow access to water for electrolysis while implanted, thereby promoting long-term implantability of the gas generator subsystem. An application of the system is a pancreatic islet (or pancreatic islet analogue) implant for treatment of Type 1 diabetes (T1D) that would be considered a bio-artificial pancreas.

System for gas treatment of a cell implant

Electrolytic gas generator and multi-functional current collector for use in same. In one embodiment, the current collector is constructed both to conduct current from an electrode to a conductive lead and to conduct gas generated at the electrode to external tubing. Accordingly, the current collector may be formed by bonding together a top metal plate and a bottom metal plate of similar profiles, each of which may be shaped to include a main portion and a lateral extension. The bottom metal plate may have central through hole in the main portion for receiving gas from the anode. The top metal plate may have a recess on its bottom surface. The recess may have a first end aligned with the through hole on the bottom metal plate and may have a second end at the end of the lateral extension. A lead and tubing may be attached to the lateral extension.

Combined electrical lead and gas port terminals and electrolytic gas generator comprising same

Implantable gas delivery device and methods, systems, and devices including same. According to one embodiment, the implantable gas delivery device includes a porous core that permits facile transport of gas throughout its open volume. The porous core has sufficiently high tensile strength to withstand pressurization without significant deformation. The porous core is generally planar and is shaped to include a pair of opposing surfaces and a periphery. Diffusion membranes are fixed to the two opposing surfaces of the porous core. A gas supply tube has one end inserted into the porous core and another end connectable to a gas source. The periphery of the porous core is sealed gas-tight, either with a gasket or by sealing the porous core and/or diffusion membranes. The device may be used to deliver a gas to an implanted cell capsule or to native cells or tissues or may be used to expel waste gas.

Robust, implantable gas delivery device and methods, systems and devices including same

Percutaneous gas diffusion device. In one embodiment, the percutaneous gas diffusion device includes a core layer, an outer layer, and an intermediate layer. The core layer may be cylindrical and may include a gas-permeable, liquid-impermeable material. The outer layer may peripherally surround the core layer and may include a tissue-integrating material. The intermediate layer may peripherally surround the core layer and may be peripherally surrounded by the outer layer. The intermediate layer may include a barrier that prevents infiltration of tissue from the outer layer into the core layer and that additionally reduces diffusion of gas from the core layer into the outer layer. The percutaneous gas diffusion device may be coupled to a subcutaneous implant device, such as a subcutaneous container holding implanted cells and/or tissue, a subcutaneous electrochemical oxygen concentrator, or a water electrolyzer.

Percutaneous gas diffusion device suitable for use with a subcutaneous implant

Self-regulating electrolytic gas generator and implant system including the same. In one embodiment, the electrolytic gas generator is a water electrolyzer and includes a polymer electrolyte membrane with an anode on one side and a cathode on the other side. Anode and cathode seals surround the peripheries of the anode and cathode and include inlets for water and outlets for oxygen and hydrogen, respectively. A cathode current collector is placed in contact with the cathode, and an anode current collector, which may be an elastic, electrically-conductive diaphragm, is positioned proximate to the anode. The anode current collector is reversibly deformable between a first state in which it is in direct physical and electrical contact with the anode and a second state in which it distends, due to gas pressure generated at the anode, so that it is not in physical or electrical contact with the anode, causing electrolysis to cease.

Self-regulating electrolytic gas generator and implant system comprising the same

System for gas treatment of cellular implants. The system enhances the viability and function of cellular implants, particularly those with high cellular density, for use in human or veterinary medicine. The system utilizes a miniaturized electrochemical gas generator subsystem that continuously supplies oxygen and/or hydrogen to cells within an implantable and immunoisolated cell containment subsystem to facilitate cell viability and function at high cellular density while minimizing overall implant size. The cell containment subsystem is equipped with features to allow gas delivery through porous tubing or gas-only permeable internal gas compartments within the implantable cell containment subsystem. Furthermore, the gas generator subsystem includes components that allow access to water for electrolysis while implanted, thereby promoting long-term implantability of the gas generator subsystem. An application of the system is a pancreatic islet (or pancreatic islet analog) implant for treatment of Type 1 diabetes (T1D) that would be considered a bio-artificial pancreas.

Method and system for organ preservation. According to one aspect, an organ may be preserved by being perfused with an in situ generated preserving gas. The organ may be, for example, a human or porcine pancreas, and perfusion of the pancreas may be anterograde, retrograde, ductal, anterograde/ductal, or retrograde/ductal. The preserving gas used to perfuse the organ may be dissolved in a liquid and then administered to the organ as a gas/liquid solution or may be mixed with one or more other gases and then administered to the organ as a gas/gas mixture. The preserving gas may be, for example, oxygen gas generated in situ using an electrochemical oxygen concentrator. According to another aspect, an organ preservation system may include an electrochemical oxygen concentrator having a water vapor feed, as well as auxiliary equipment to control and measure delivery pressure, flow, temperature and humidity.

Perfusing an organ with an in situ generated gas

System for fluid perfusion of biological matter that includes tissue. According to one embodiment, the system may include a storage container for storing the biological matter, a thermal control device for cooling the contents of the storage container, a gas generator for generating a preserving gas, a fluid conduit coupled to the gas generator and insertable into tissue for delivering the preserving gas to the biological matter, and a process controller for controlling the operation of the gas generator and the thermal control device. The gas generator, in turn, may include an electrochemical oxygen concentrator and/or a water electrolyzer for generating the preserving gas. The system may further include a liquid perfusion system that includes a reservoir of liquid perfusate, a fluid delivery conduit for delivering liquid perfusate from the reservoir to the biological matter, and a fluid draining conduit for draining liquid perfusate from the biological matter.

System for fluid perfusion of biological matter comprising tissue

A fuel cell and method using the same. The fuel cell comprises a membrane electrode assembly, the membrane electrode assembly comprising a proton exchange membrane having a front face and a rear face. An anode is coupled to the front face of the proton exchange membrane, and a cathode is coupled to the rear face of the proton exchange membrane. A vapor diffusion chamber is positioned in the front of the anode, and a vapor transport member is positioned in front of the vapor diffusion chamber. The vapor transport member is substantially impermeable to an organic fuel/water mixture in a liquid phase but is permeable to the organic fuel/water mixture in a vapor phase. In operation, a liquid fuel mixture delivered to the vapor transport member evaporates from the vapor transport member and is delivered to the anode in vapor form.

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Arlington, MA, United States of America

Simon G Stone