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Id Matter Usage Term Definition Doc No Modified Actions
2123 DAR-2 Defined defoamer
"Defoamer" refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to remove and/or mitigate the presence of foam or bubbles in a fluid. In certain embodiments, a defoamer can also include features that remove or eliminate particulates, debris, air bubbles and other bubbles in a fluid. In certain embodiments, a defoamer is a specialized filter that concentrates on the removal of bubbles and/or air in a fluid. "Defoamer" refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to remove and/or mitigate the presence of foam or bubbles in a fluid. In certain embodiments, a defoamer can also include features that remove or eliminate particulates, debris, air bubbles and other bubbles in a fluid. In certain embodiments, a defoamer is a specialized filter that concentrates on the removal of bubbles and/or air in a fluid.
DAR-2 9/18/23, 8:47 PM Add Term Edit
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2108 DAR-2 Defined measured parameter
"Measured Parameter" refers to any parameter that can be measured for a particular device, apparatus, process, method, circuit, or the like. In the context of a perfusion circuit, a measured parameter can include any perfusion parameter that can be measured. Examples of measured parameters in a perfusion circuit, can include, a flow rate, a fluid pressure, a temperature, a weight, an Oxygen saturation (SO2) level, an oxygen (CaO2) content level, Oxygen utilization, Oxygen extraction, vascular resistance, aortic insufficiency level, ventricular P-V loop characteristics, glucose level, lactate level, a pH level, a hematocrit level, a carbon dioxide (pCO2) partial pressure level, a carbon dioxide content (%CO2), electrocardiogram (EKG) reading, beat rate of heart, a partial pressure of Oxygen (pO2), a motor speed, filtrate removal rate, gas flowrate, and the like. "Measured Parameter" refers to any parameter that can be measured for a particular device, apparatus, process, method, circuit, or the like. In the context of a perfusion circuit, a measured parameter can include any perfusion parameter that can be measured. Examples of measured parameters in a perfusion circuit, can include, a flow rate, a fluid pressure, a temperature, a weight, an Oxygen saturation (SO2) level, an oxygen (CaO2) content level, Oxygen utilization, Oxygen extraction, vascular resistance, aortic insufficiency level, ventricular P-V loop characteristics, glucose level, lactate level, a pH level, a hematocrit level, a carbon dioxide (pCO2) partial pressure level, a carbon dioxide content (%CO2), electrocardiogram (EKG) reading, beat rate of heart, a partial pressure of Oxygen (pO2), a motor speed, filtrate removal rate, gas flowrate, and the like.
DAR-2 9/18/23, 8:00 PM Add Term Edit
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2120 DAR-2 Defined continuous refreshed perfusate
"Continuous Refreshed Perfusate" refers to a quantity of perfusate that is refreshed from a suboptimal state to a more optimal state without interrupting, disrupting, or stopping fluid flow within a perfusion circuit. As used herein, continuous refers to a process with no break or interruption, as well as a process with a nominal break or interruption, as well as a process with a break or interruption that is small or short enough that one or more perfused organ experiences nominal or no adverse effects from the break or interruption. Those of skill in the art will appreciate that the perfusate can be refreshed using a variety of methods, processes, techniques, devices, structures, systems, apparatuses, and the like. For example, the perfusate can be refreshed by way of one or more inline filters, a hemofiltration process (conducting using mechanical devices and/or living organs), a bulk perfusate exchange process, a constant perfusate replacement process, a dialysis process, a blood gas exchange process, a pH adjustment process, a temperature adjustment process, an oncotic pressure adjustment process, an addition of one or more nutrients, an addition of one or more additives, an addition of one or more supplements, an addition of one or more drugs, or the like. "Continuous Refreshed Perfusate" refers to a quantity of perfusate that is refreshed from a suboptimal state to a more optimal state without interrupting, disrupting, or stopping fluid flow within a perfusion circuit. As used herein, continuous refers to a process with no break or interruption, as well as a process with a nominal break or interruption, as well as a process with a break or interruption that is small or short enough that one or more perfused organ experiences nominal or no adverse effects from the break or interruption. Those of skill in the art will appreciate that the perfusate can be refreshed using a variety of methods, processes, techniques, devices, structures, systems, apparatuses, and the like. For example, the perfusate can be refreshed by way of one or more inline filters, a hemofiltration process (conducting using mechanical devices and/or living organs), a bulk perfusate exchange process, a constant perfusate replacement process, a dialysis process, a blood gas exchange process, a pH adjustment process, a temperature adjustment process, an oncotic pressure adjustment process, an addition of one or more nutrients, an addition of one or more additives, an addition of one or more supplements, an addition of one or more drugs, or the like.
DAR-2 9/18/23, 8:00 PM Add Term Edit
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2124 DAR-2 Defined partial working mode perfusion
"Partial Working Mode Perfusion" or "Left Atrial Perfusion" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit such that the doner heart pumps a perfusate supplied to the left atrium into the left ventricle and then into the aorta and into coronary arteries. From the aorta, the perfusate passes through one or more compliance and/or resistance components designed to simulate the compliance and resistance the ex vivo heart would experience in the body of a recipient. The perfusate exits the compliance and/or resistance components into a perfusion reservoir. The perfusate also circulates through the coronary arteries and back into the right ventricle of the doner heart, then through the right atrium, the right ventricle, and the pulmonary artery into the perfusion reservoir, and eventually back into the left atrium to repeat the perfusion circuit after having been reoxygenated. The partial working mode perfusion procedure is intended to simulate operation of the left side of the ex vivo heart. "Partial Working Mode Perfusion" or "Left Atrial Perfusion" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit such that the doner heart pumps a perfusate supplied to the left atrium into the left ventricle and then into the aorta and into coronary arteries. From the aorta, the perfusate passes through one or more compliance and/or resistance components designed to simulate the compliance and resistance the ex vivo heart would experience in the body of a recipient. The perfusate exits the compliance and/or resistance components into a perfusion reservoir. The perfusate also circulates through the coronary arteries and back into the right ventricle of the doner heart, then through the right atrium, the right ventricle, and the pulmonary artery into the perfusion reservoir, and eventually back into the left atrium to repeat the perfusion circuit after having been reoxygenated. The partial working mode perfusion procedure is intended to simulate operation of the left side of the ex vivo heart.
DAR-2 9/18/23, 7:46 PM Add Term Edit
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2106 DAR-2 Defined full working mode perfusion
"Working Mode Perfusion" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit such that the doner heart pumps a perfusate supplied to the left atrium into the left ventricle and then into the aorta and into coronary arteries. From the aorta, the perfusate passes through one or more compliance and/or resistance components designed to simulate the compliance and resistance the ex vivo heart would experience in the body of a recipient. The perfusate exits the compliance and/or resistance components into a perfusion reservoir. The perfusate also circulates through the coronary arteries and back into the right ventricle of the doner heart, where it joins a perfusate supplied to the right atrium which is pumped by the heart into the right ventricle which pumps perfusate into the pulmonary artery. From the pulmonary artery, the perfusate passes through one or more compliance and/or resistance components designed to simulate the pulmonary compliance and pulmonary vascular resistance the ex vivo heart would experience in the body of a recipient, returning into the perfusion reservoir, and eventually back into the left and right atria to repeat the perfusion circuit after having been reoxygenated. The Working Mode Perfusion procedure is intended to simulate operation of the ex vivo heart in a recipient. "Working Mode Perfusion" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit such that the doner heart pumps a perfusate supplied to the left atrium into the left ventricle and then into the aorta and into coronary arteries. From the aorta, the perfusate passes through one or more compliance and/or resistance components designed to simulate the compliance and resistance the ex vivo heart would experience in the body of a recipient. The perfusate exits the compliance and/or resistance components into a perfusion reservoir. The perfusate also circulates through the coronary arteries and back into the right ventricle of the doner heart, where it joins a perfusate supplied to the right atrium which is pumped by the heart into the right ventricle which pumps perfusate into the pulmonary artery. From the pulmonary artery, the perfusate passes through one or more compliance and/or resistance components designed to simulate the pulmonary compliance and pulmonary vascular resistance the ex vivo heart would experience in the body of a recipient, returning into the perfusion reservoir, and eventually back into the left and right atria to repeat the perfusion circuit after having been reoxygenated. The Working Mode Perfusion procedure is intended to simulate operation of the ex vivo heart in a recipient.
DAR-2 9/18/23, 7:44 PM Add Term Edit
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2105 DAR-2 Defined langendorff perfusion
"Langendorff perfusion" or "Beating Heart, Resting Mode" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit to pump perfusate in a retrograde manner into the ligated aorta and antegrade thru the coronary arteries of the heart to nourish the doner heart and remove waste. The perfusate circulates through the coronary arteries and back into the right atrium of the doner heart, then into the right ventricle, returning thru cannula and tubing to the perfusion reservoir via the pulmonary artery, and eventually back into the aorta and coronary arteries after having been reoxygenated. The perfusion procedure is named for Otto Langendorff who developed the procedure. "Langendorff perfusion" or "Beating Heart, Resting Mode" refers to a perfusion procedure, process, method, or mode for an ex vivo heart organ. The procedure involves perfusing a doner heart using a perfusion circuit to pump perfusate in a retrograde manner into the ligated aorta and antegrade thru the coronary arteries of the heart to nourish the doner heart and remove waste. The perfusate circulates through the coronary arteries and back into the right atrium of the doner heart, then into the right ventricle, returning thru cannula and tubing to the perfusion reservoir via the pulmonary artery, and eventually back into the aorta and coronary arteries after having been reoxygenated. The perfusion procedure is named for Otto Langendorff who developed the procedure.
DAR-2 9/18/23, 7:39 PM Add Term Edit
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2102 DAR-2 Defined control loop
"Control Loop" refers to a closed-loop process, method, or system that continuously monitors and adjusts a process to maintain a desired setpoint or target. Control loops can regulate and optimize processes, ensuring the processes operate within specified parameters and deliver consistent and reliable results. A control loop often includes the following components: Process: The process is the system or operation that needs to be controlled or regulated. This could be a manufacturing process, a heating or cooling system, a chemical reaction, a biological process, a physiological process, or any other system with variable inputs, outputs, and/or parameters. Setpoint: The setpoint is the desired or target value that the process should achieve or maintain. The setpoint represents the ideal operating condition for the process. Sensor (or Measuring Device): The sensor is a device that measures the current state, condition, or output of the process or one or more components and/or stages of a process. The sensor provides feedback for an actual process variable (PV) and sends this information to a controller. Controller: The controller can be a device and/or software of a computing device that receives input from the sensor and compares the input to the setpoint. Based on this comparison, the controller calculates the necessary control action to bring the process variable back to the setpoint. Actuator: The actuator is a device, component, or mechanism that receives signals from the controller and physically adjusts the process or components or other aspects of a process to achieve the desired setpoint. The adjusted aspect could be a valve position, flow rate, flow pressure, motor revolutions per minute, motor on or off state, gate or port state (open or closed), proportional pinch valve position, heater/cooler increasing or decreasing heat/cold output, mass flow control (e.g., sweep gas flowrate) or any other device that can change a parameter of the process. Feedback Loop: The feedback loop is the continuous flow of information and control signals between the sensor, controller, and actuator. The feedback loop allows the controller to make real-time adjustments to keep the process variable close to or at the setpoint. A control loop can include one or more of setpoints, sensors, controllers, actuators, and/or feedback loops. The basic operation of a control loop involves the controller comparing the actual process variable (PV) with the setpoint (SP) and generating a control signal that instructs the actuator to make adjustments. The process variable can be continuously measured and controlled to minimize deviation from the setpoint, ensuring that the process operates efficiently and within desired limits. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Sept. 7, 2023). "Control Loop" refers to a closed-loop process, method, or system that continuously monitors and adjusts a process to maintain a desired setpoint or target. Control loops can regulate and optimize processes, ensuring the processes operate within specified parameters and deliver consistent and reliable results. A control loop often includes the following components: Process: The process is the system or operation that needs to be controlled or regulated. This could be a manufacturing process, a heating or cooling system, a chemical reaction, a biological process, a physiological process, or any other system with variable inputs, outputs, and/or parameters. Setpoint: The setpoint is the desired or target value that the process should achieve or maintain. The setpoint represents the ideal operating condition for the process. Sensor (or Measuring Device): The sensor is a device that measures the current state, condition, or output of the process or one or more components and/or stages of a process. The sensor provides feedback for an actual process variable (PV) and sends this information to a controller. Controller: The controller can be a device and/or software of a computing device that receives input from the sensor and compares the input to the setpoint. Based on this comparison, the controller calculates the necessary control action to bring the process variable back to the setpoint. Actuator: The actuator is a device, component, or mechanism that receives signals from the controller and physically adjusts the process or components or other aspects of a process to achieve the desired setpoint. The adjusted aspect could be a valve position, flow rate, flow pressure, motor revolutions per minute, motor on or off state, gate or port state (open or closed), proportional pinch valve position, heater/cooler increasing or decreasing heat/cold output, mass flow control (e.g., sweep gas flowrate) or any other device that can change a parameter of the process. Feedback Loop: The feedback loop is the continuous flow of information and control signals between the sensor, controller, and actuator. The feedback loop allows the controller to make real-time adjustments to keep the process variable close to or at the setpoint. A control loop can include one or more of setpoints, sensors, controllers, actuators, and/or feedback loops. The basic operation of a control loop involves the controller comparing the actual process variable (PV) with the setpoint (SP) and generating a control signal that instructs the actuator to make adjustments. The process variable can be continuously measured and controlled to minimize deviation from the setpoint, ensuring that the process operates efficiently and within desired limits. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Sept. 7, 2023).
DAR-2 9/18/23, 7:32 PM Add Term Edit
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2101 DAR-2 Defined bulk perfusate diversion system
"Bulk Perfusate Diversion System" refers to a diversion system, structure, subsystem, device, apparatus, assembly, or the like that is organized, configured, designed, arranged, or engineered to divert, exchange, and/or replace a large quantity of perfusate within a fluid circuit, where large is a quantity greater than or equal to about twenty-five percent of the perfusate volume in a perfusate circuit. For example suppose a quantity of perfusate within a fluid circuit is between about 600cc to about just less than 1000 cc. For such an example, a large quantity of may be between about 150 cc and about 250 cc. In another example a quantity of perfusate within a fluid circuit may be between about 1500 cc. For such an example, a large quantity of is between about 375 cc. "Bulk Perfusate Diversion System" refers to a diversion system, structure, subsystem, device, apparatus, assembly, or the like that is organized, configured, designed, arranged, or engineered to divert, exchange, and/or replace a large quantity of perfusate within a fluid circuit, where large is a quantity greater than or equal to about twenty-five percent of the perfusate volume in a perfusate circuit. For example suppose a quantity of perfusate within a fluid circuit is between about 600cc to about just less than 1000 cc. For such an example, a large quantity of may be between about 150 cc and about 250 cc. In another example a quantity of perfusate within a fluid circuit may be between about 1500 cc. For such an example, a large quantity of is between about 375 cc.
DAR-2 9/18/23, 6:29 PM Add Term Edit
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2109 DAR-2 Defined revitalized perfusate
"Revitalized Perfusate" refers to a quantity of perfusate having a state or condition that is higher or better than another quantity of perfusate used or to be used in a perfusion circuit. In certain embodiments, revitalized perfusate refers to a quantity perfusate that has undergone some form of cleaning, cleansing, purifying, or filtration process. In another embodiment, revitalized perfusate refers to a quantity perfusate that has been prepared, manufactured, or fabricated for use in perfusion but has not yet been used in a perfusion process. In another embodiment, revitalized perfusate refers to a quantity perfusate that has received an additive, a drug, and/or supplement that improves the condition of the perfusate for use in a perfusion process. In one embodiment, a revitalized perfusate is obtained by one or more components of a perfusion circuit processing the perfusate. In another embodiment, a revitalized perfusate is obtained by introducing revitalized perfusate to a perfusion circuit. In another embodiment, a revitalized perfusate is obtained by introducing revitalized perfusate to a perfusion circuit and removing a quantity of perfusate replaced by the revitalized perfusate. In one embodiment, revitalized perfusate refers to a quantity perfusate that has received a nutrient, an additive, a drug, and/or supplement that improves the condition of the perfusate for use in a perfusion process. In one embodiment, a revitalized perfusate is obtained by one or more components of a perfusion circuit processing perfusate that is already circulating in a perfusion circuit. In one embodiment, a revitalized perfusate is obtained by introducing a quantity of revitalized perfusate to a perfusion circuit. A revitalized perfusate can include a perfusate that has had one or more waste products removed. A revitalized perfusate can include a perfusate that has had one or more nutrients and/or drugs added. A revitalized perfusate can include a perfusate that has had one or more waste products removed and one or more nutrients added. "Revitalized Perfusate" refers to a quantity of perfusate having a state or condition that is higher or better than another quantity of perfusate used or to be used in a perfusion circuit. In certain embodiments, revitalized perfusate refers to a quantity perfusate that has undergone some form of cleaning, cleansing, purifying, or filtration process. In another embodiment, revitalized perfusate refers to a quantity perfusate that has been prepared, manufactured, or fabricated for use in perfusion but has not yet been used in a perfusion process. In another embodiment, revitalized perfusate refers to a quantity perfusate that has received an additive, a drug, and/or supplement that improves the condition of the perfusate for use in a perfusion process. In one embodiment, a revitalized perfusate is obtained by one or more components of a perfusion circuit processing the perfusate. In another embodiment, a revitalized perfusate is obtained by introducing revitalized perfusate to a perfusion circuit. In another embodiment, a revitalized perfusate is obtained by introducing revitalized perfusate to a perfusion circuit and removing a quantity of perfusate replaced by the revitalized perfusate. In one embodiment, revitalized perfusate refers to a quantity perfusate that has received a nutrient, an additive, a drug, and/or supplement that improves the condition of the perfusate for use in a perfusion process. In one embodiment, a revitalized perfusate is obtained by one or more components of a perfusion circuit processing perfusate that is already circulating in a perfusion circuit. In one embodiment, a revitalized perfusate is obtained by introducing a quantity of revitalized perfusate to a perfusion circuit. A revitalized perfusate can include a perfusate that has had one or more waste products removed. A revitalized perfusate can include a perfusate that has had one or more nutrients and/or drugs added. A revitalized perfusate can include a perfusate that has had one or more waste products removed and one or more nutrients added.
DAR-2 9/18/23, 6:11 PM Add Term Edit
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2067 DAR-2 Defined Normothermic Ex Vivo Perfusion (NEVP)
"Normothermic Ex Vivo Perfusion" (NEVP) or "Normothermic perfusion" refers to a form of perfusion involving an organ outside a body of a human or animal that is perfused at a temperate at or about a normal temperature the organ experiences when functioning within a human or animal. NEVP can also include temperatures slightly lower than normal which is subnormothermic. In example implementations a NEVP system or apparatus can include settings for temperatures in the following ranges: Hypothermic about +4C degrees to about +10C degrees; Subnormothermic about 15C degrees to about 30C degrees; Normothermic about 37C degrees. "Normothermic Ex Vivo Perfusion" (NEVP) or "Normothermic perfusion" refers to a form of perfusion involving an organ outside a body of a human or animal that is perfused at a temperate at or about a normal temperature the organ experiences when functioning within a human or animal. NEVP can also include temperatures slightly lower than normal which is subnormothermic. In example implementations a NEVP system or apparatus can include settings for temperatures in the following ranges: Hypothermic about +4C degrees to about +10C degrees; Subnormothermic about 15C degrees to about 30C degrees; Normothermic about 37C degrees.
DAR-2 9/18/23, 6:07 PM Add Term Edit
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2066 DAR-2 Defined oxygenator
"Oxygenator" refers to any structure, apparatus, surface, device, system, feature, or aspect configured for use in extracorporeal circulation systems, such as normothermic ex-vivo perfusion system. An oxygenator's primary function is to exchange oxygen and carbon dioxide with the patient's blood, a perfusion fluid, and/or a perfusate. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 30, 2023). In one embodiment, an oxygenator can be configured to exchange gases in order to maintain a target level of oxygen (O2) content and target carbon dioxide (CO2) level (or pH) of a perfusate for a perfusion operation. In certain embodiments, an oxygenator may include functionality to heat or cool a fluid supplied to the oxygenator. Consequently, the oxygenator may include a heater and/or a cooler .In one implementation, an oxygenator may have a hollow fiber membrane section or metallic tubes in contact with blood or perfusate that carry circulated temperature controlled water that is provided by a heater/cooler in order to transfer thermal energy to or from the blood or perfusate. "Oxygenator" refers to any structure, apparatus, surface, device, system, feature, or aspect configured for use in extracorporeal circulation systems, such as normothermic ex-vivo perfusion system. An oxygenator's primary function is to exchange oxygen and carbon dioxide with the patient's blood, a perfusion fluid, and/or a perfusate. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 30, 2023). In one embodiment, an oxygenator can be configured to exchange gases in order to maintain a target level of oxygen (O2) content and target carbon dioxide (CO2) level (or pH) of a perfusate for a perfusion operation. In certain embodiments, an oxygenator may include functionality to heat or cool a fluid supplied to the oxygenator. Consequently, the oxygenator may include a heater and/or a cooler .In one implementation, an oxygenator may have a hollow fiber membrane section or metallic tubes in contact with blood or perfusate that carry circulated temperature controlled water that is provided by a heater/cooler in order to transfer thermal energy to or from the blood or perfusate.
DAR-2 9/18/23, 6:03 PM Add Term Edit
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2064 DAR-2 Defined donor
"Donor" refers to an animal or human from which an organ is harvested that is to be used in an Ex Vivo perfusion system. "Donor" refers to an animal or human from which an organ is harvested that is to be used in an Ex Vivo perfusion system.
DAR-2 9/18/23, 6:00 PM Add Term Edit
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2078 DAR-2 Defined hemofiltration
"Hemofiltration" refers to a process, method, procedure that filters and cleanses blood (or a blood substitute such as a perfusate) by removing excess fluid, waste products, and electrolytes from the bloodstream. Hemofiltration can be considered a form of renal replacement therapy. In one embodiment of hemofiltration, the blood (or a blood substitute such as a perfusate) passes through a semipermeable membrane, which allows a fluid of water, electrolytes, and small molecules (including waste products) to pass through while retaining larger blood cells and proteins. This fluid that passes through the membrane, along with waste products and excess electrolytes, can be referred to as an ultrafiltrate or simply filtrate. The ultrafiltrate can be collected and discarded to effectively remove excess fluid from the bloodstream/blood circuit. To prevent excessive removal of fluid and/or certain electrolytes, drugs, and/or nutrients, a replacement fluid, referred to herein as a filtrate replacement fluid (FRF) or ultrafiltrate replacement fluid (UFRF) together with, or without, drugs and/or nutrients, can be infused back into the bloodstream/blood circuit. This helps maintain a desired composition in the bloodstream/blood circuit. In hemofiltration, a portion of the blood (or a blood substitute such as a perfusate) that does not pass through the membrane and remains on the intake or input side of the membrane is referred to as a retentate. Retentate can include water, blood cells, proteins, and larger solutes. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 31, 2023). "Hemofiltration" refers to a process, method, procedure that filters and cleanses blood (or a blood substitute such as a perfusate) by removing excess fluid, waste products, and electrolytes from the bloodstream. Hemofiltration can be considered a form of renal replacement therapy. In one embodiment of hemofiltration, the blood (or a blood substitute such as a perfusate) passes through a semipermeable membrane, which allows a fluid of water, electrolytes, and small molecules (including waste products) to pass through while retaining larger blood cells and proteins. This fluid that passes through the membrane, along with waste products and excess electrolytes, can be referred to as an ultrafiltrate or simply filtrate. The ultrafiltrate can be collected and discarded to effectively remove excess fluid from the bloodstream/blood circuit. To prevent excessive removal of fluid and/or certain electrolytes, drugs, and/or nutrients, a replacement fluid, referred to herein as a filtrate replacement fluid (FRF) or ultrafiltrate replacement fluid (UFRF) together with, or without, drugs and/or nutrients, can be infused back into the bloodstream/blood circuit. This helps maintain a desired composition in the bloodstream/blood circuit. In hemofiltration, a portion of the blood (or a blood substitute such as a perfusate) that does not pass through the membrane and remains on the intake or input side of the membrane is referred to as a retentate. Retentate can include water, blood cells, proteins, and larger solutes. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 31, 2023).
DAR-2 9/18/23, 5:59 PM Add Term Edit
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2088 DAR-2 Defined organ chamber
"Organ Chamber" refers to any apparatus, instrument, structure, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to hold, support, retain, house, enclose, or contain one or more organs. An organ chamber can include a base and a cover, dome, lid, or door, and/or one or more access ports or openings to permit access to the organ by tubing, hoses, probes, wires, conduit, instruments, or the like. In certain embodiments, an organ chamber may be made of plastic or glass and may be reusable or disposable. In certain embodiments, an organ chamber can be implemented as a flexible sac arranged to hold and support the organ. The organ chamber may also include or may be filled with fluid. When implemented as a flexible sac or a structure that includes fluid, this can allows ultrasonic evaluation of the organ and its anatomical structure. "Organ Chamber" refers to any apparatus, instrument, structure, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to hold, support, retain, house, enclose, or contain one or more organs. An organ chamber can include a base and a cover, dome, lid, or door, and/or one or more access ports or openings to permit access to the organ by tubing, hoses, probes, wires, conduit, instruments, or the like. In certain embodiments, an organ chamber may be made of plastic or glass and may be reusable or disposable. In certain embodiments, an organ chamber can be implemented as a flexible sac arranged to hold and support the organ. The organ chamber may also include or may be filled with fluid. When implemented as a flexible sac or a structure that includes fluid, this can allows ultrasonic evaluation of the organ and its anatomical structure.
DAR-2 9/18/23, 5:55 PM Add Term Edit
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2122 DAR-2 Defined continuous perfusion
“Continuous Perfusion” refers to a type of organ perfusion in which the perfusion process, method, apparatus, system, and/or protocol operates without interruption, stoppage, or break. “Continuous Perfusion” can also refer to a perfusion process, method, apparatus, system, and/or protocol that includes an interruption, stoppage, or break, but the interruption, stoppage, or break is so small or so short that it has substantially no or little impact on the viability of a perfused organ. Alternatively, or in addition, “Continuous Perfusion” can also refer to a perfusion process, method, apparatus, system, and/or protocol that includes an interruption, stoppage, or break, but the interruption, stoppage, or break designed to overlap with a natural break or relaxation phase of an existing perfusion process, method, apparatus, system, and/or protocol. “Continuous Perfusion” refers to a type of organ perfusion in which the perfusion process, method, apparatus, system, and/or protocol operates without interruption, stoppage, or break. “Continuous Perfusion” can also refer to a perfusion process, method, apparatus, system, and/or protocol that includes an interruption, stoppage, or break, but the interruption, stoppage, or break is so small or so short that it has substantially no or little impact on the viability of a perfused organ. Alternatively, or in addition, “Continuous Perfusion” can also refer to a perfusion process, method, apparatus, system, and/or protocol that includes an interruption, stoppage, or break, but the interruption, stoppage, or break designed to overlap with a natural break or relaxation phase of an existing perfusion process, method, apparatus, system, and/or protocol.
DAR-2 9/12/23, 2:45 PM Add Term Edit
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2121 DAR-2 Defined replaceable reservoir
"Replaceable Reservoir" refers to any reservoir, tank, or fluid holding structure configured, designed, and/or engineered to be replaced within a fluid circuit. A "replaceable reservoir" also refers to any reservoir, tank, or fluid holding structure configured, designed, and/or engineered to enable replacement of a quantity of fluid supplied by the replaceable reservoir. In one embodiment, a replaceable reservoir is disposable. In one embodiment, a replaceable reservoir is reusable. In one embodiment, a replaceable reservoir includes a set of chambers, for example a pair of chambers and one chamber (or the fluid of one chamber) can be replaced while another chamber is in use. In one embodiment, a replaceable reservoir includes a set of cartridges, for example a pair of cartridges and one cartridge can be replaced while another cartridge is in use. "Replaceable Reservoir" refers to any reservoir, tank, or fluid holding structure configured, designed, and/or engineered to be replaced within a fluid circuit. A "replaceable reservoir" also refers to any reservoir, tank, or fluid holding structure configured, designed, and/or engineered to enable replacement of a quantity of fluid supplied by the replaceable reservoir. In one embodiment, a replaceable reservoir is disposable. In one embodiment, a replaceable reservoir is reusable. In one embodiment, a replaceable reservoir includes a set of chambers, for example a pair of chambers and one chamber (or the fluid of one chamber) can be replaced while another chamber is in use. In one embodiment, a replaceable reservoir includes a set of cartridges, for example a pair of cartridges and one cartridge can be replaced while another cartridge is in use.
DAR-2 9/12/23, 2:17 PM Add Term Edit
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2094 DAR-2 Defined reservoir or fluid reservoir
“Reservoir” or “Fluid Reservoir” refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to store, retain, or hold a fluid. In certain embodiments, a reservoir may include a plurality of components coupled to, connected to, and/or integrated with the reservoir. In certain embodiments, a reservoir is an open container. In one embodiment, a reservoir is a closed, sealed container. In one embodiment, a reservoir includes a lid or cap that enables the reservoir to operate either open or closed and/or sealed. In certain embodiments, a reservoir can include a plurality of containers or chambers. “Reservoir” or “Fluid Reservoir” refers to an apparatus, instrument, structure, member, device, component, system, or assembly structured, organized, configured, designed, arranged, or engineered to store, retain, or hold a fluid. In certain embodiments, a reservoir may include a plurality of components coupled to, connected to, and/or integrated with the reservoir. In certain embodiments, a reservoir is an open container. In one embodiment, a reservoir is a closed, sealed container. In one embodiment, a reservoir includes a lid or cap that enables the reservoir to operate either open or closed and/or sealed. In certain embodiments, a reservoir can include a plurality of containers or chambers.
DAR-2 9/12/23, 2:02 PM Add Term Edit
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2081 DAR-2 Defined organ
"Organ" refers to a distinct anatomical structure composed of specialized tissues that perform specific functions within an organism's body. Organs are essential components of living organisms, ranging from simple organisms to complex multicellular organisms including animals and humans. Organs cooperate to support the overall function of an organism and maintain its physiological processes. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 30, 2023). Examples of an organ include tissue and body parts, including arms, hands, feet, legs, fingers, toes and include organs such as a heart, a brain, a kidney, a lung, a pancreas, a stomach, an intestine, a liver, and the like. "Organ" refers to a distinct anatomical structure composed of specialized tissues that perform specific functions within an organism's body. Organs are essential components of living organisms, ranging from simple organisms to complex multicellular organisms including animals and humans. Organs cooperate to support the overall function of an organism and maintain its physiological processes. (© ChatGPT Aug. 3 Version, Modified, accessed chat.openai.com/chat Aug. 30, 2023). Examples of an organ include tissue and body parts, including arms, hands, feet, legs, fingers, toes and include organs such as a heart, a brain, a kidney, a lung, a pancreas, a stomach, an intestine, a liver, and the like.
DAR-2 9/11/23, 5:05 PM Add Term Edit
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2063 DAR-2 Defined perfusion
"Perfusion" refers to an act of forcing a fluid to flow or driving a fluid over or through something, especially through an organ, tissue, or other part of the body of a human or animal. (Search "perfuse" on wordhippo.com. WordHippo, 2023. Web. Modified. Accessed 30 Aug. 2023.) Often, the fluid used in perfusion is blood, a blood-based product, and/or a blood substitute. "Perfusion" refers to an act of forcing a fluid to flow or driving a fluid over or through something, especially through an organ, tissue, or other part of the body of a human or animal. (Search "perfuse" on wordhippo.com. WordHippo, 2023. Web. Modified. Accessed 30 Aug. 2023.) Often, the fluid used in perfusion is blood, a blood-based product, and/or a blood substitute.
DAR-2 9/11/23, 4:33 PM Add Term Edit
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2119 DAR-2 Defined perfusate supply exchange system
"Perfusate Supply Exchange System" refers to any system that exchanges a quantity of at least twenty-five percent of a perfusate in a perfusion circuit with another quantity of at least twenty-five percent of a replacement perfusate for the perfusion circuit. A perfusate supply exchange system can be integrated with and/or in line with a fluid circuit or a perfusate supply exchange system can be separate and independent of a fluid circuit. One example of a perfusate supply exchange system is dual chamber/bladder disclosed herein. "Perfusate Supply Exchange System" refers to any system that exchanges a quantity of at least twenty-five percent of a perfusate in a perfusion circuit with another quantity of at least twenty-five percent of a replacement perfusate for the perfusion circuit. A perfusate supply exchange system can be integrated with and/or in line with a fluid circuit or a perfusate supply exchange system can be separate and independent of a fluid circuit. One example of a perfusate supply exchange system is dual chamber/bladder disclosed herein.
DAR-2 9/8/23, 8:09 PM Add Term Edit
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