Extracorporeal blood treatment for organ support

Abstract

Extracorporeal blood treatment devices, methods, and systems are described herein for extracorporeal blood treatment using an organic filter operable to perform the function of an organ. An extracorporeal blood treatment device includes a treatment kit, a high flow pump, a first low flow pump, and a second low flow pump, and a computing device operatively coupled to the extracorporeal blood treatment device. The computing device may be configured to perform extracorporeal blood treatment using the extracorporeal blood treatment device and the organic filter.

Description

Technical Field

[0001] The disclosure herein relates to extracorporeal blood treatment using an extracorporeal blood treatment apparatus. More particularly, the disclosure relates to apparatus, devices, methods, systems, and treatment kits for extracorporeal blood treatment for organ support. Background Art

[0002] Extracorporeal blood treatment can refer to the process of removing blood from a patient, treating it outside the patient's body, and returning the treated blood to the patient. Extracorporeal blood treatment is often used to extract harmful substances or molecules from a patient's blood and / or to add beneficial substances or molecules to the blood. Extracorporeal blood treatment can be used for patients who are unable to effectively remove substances from their blood, for example, in cases where the patient suffers from temporary or permanent liver failure. These and other patients may, for example, receive extracorporeal blood treatment to add or remove substances from their blood, maintain acid-base balance, or remove excess body fluids or toxins.

[0003] In various extracorporeal blood treatments, one or more fluids or liquids may be supplied to the extracorporeal blood treatment apparatus for use during treatment, and one or more fluids may be collected as part of the treatment. Depending on the extracorporeal blood treatment, various kit and tubing configurations, as well as various medical devices, may be used. Summary of the Invention

[0004] This disclosure describes one or more illustrative embodiments of apparatus, devices, systems, and methods for providing extracorporeal blood treatment for organ support to a patient. For example, an extracorporeal blood treatment apparatus or system can be used to perform extracorporeal blood treatment on a patient using an organic filter that is operable to perform the function of a human liver organ. In this case, blood can be drawn from the patient and passed through the organic filter before being returned to the patient. For example, the organic filter can be a transplanted liver organ or a synthetic liver organ, which can be used as an organic liver or a bioengineered organ, artificial organ, biohybrid organ, etc. as discussed herein. In alternative embodiments, the apparatus, device, system, and method can instead be used for kidney support and use an organic filter that is operable to perform the function of a human kidney organ. In alternative embodiments, the apparatus, device, system, and method can instead be used for lung support and use an organic filter that is operable to perform the function of a human lung organ. In alternative embodiments, unfiltered blood is not drawn from the patient's vascular system but rather from a storage container (e.g., a blood bag).

[0005] The device or system may also include a computing device that can control the extracorporeal blood treatment for organ support. The computing device can control the flow rate of each pump in the extracorporeal blood treatment device to achieve or maintain a pressure at a certain location in the treatment suite, or to achieve or maintain the weight of each component of the extracorporeal blood treatment device, and can control the flow rate of each pump based on other variables (e.g., a desired flow rate or the amount of a substance or toxin in the blood). The computing device can control and adjust the flow rate of each pump to control the pressure or weight as described herein.

[0006] An illustrative extracorporeal blood treatment system may include an apparatus for performing extracorporeal blood treatment. The apparatus may perform treatment using an organic filter. The organic filter may be operable to perform the function of a human organ. The apparatus may include a treatment kit. The treatment kit may include tubing. The treatment kit may be operatively coupled to a patient. The treatment kit may be configured to move blood from the patient to the organic filter. The treatment kit may return filtered blood to the patient. The treatment kit may include a high-flow pump. The high-flow pump may be operatively coupled to the treatment kit to move blood from a buffer reservoir through the treatment kit toward the organic filter. The treatment kit may include a first low-flow pump. The first low-flow pump may be operatively coupled to the treatment kit to move blood from the patient through the treatment kit toward the organic filter. The treatment kit may include a second low-flow pump. The second low-flow pump may be operatively coupled to the treatment kit to move blood from the organic filter through the treatment kit toward the patient. The apparatus may include a computing device. The computing device may be operatively coupled to the pump. The computing device may be configured to perform extracorporeal blood treatment by controlling the pump.

[0007] An illustrative treatment kit may include an access line. The access line may be operatively coupled to a patient. The access line may be configured to receive blood from the patient. The treatment kit may include a buffer reservoir line. The buffer reservoir line may be operatively coupled to a buffer reservoir. The buffer reservoir line may be configured to receive blood from the buffer reservoir. The treatment kit may include an organic filter inlet line. The organic filter inlet line may be operatively coupled to the access line, the buffer reservoir line, and the organic filter. The organic filter inlet line may be configured to move blood from the access line and the buffer reservoir line to the organic filter. The treatment kit may include an organic filter outlet line. The organic filter outlet line may be operatively coupled to the organic filter and the buffer reservoir. The organic filter outlet line may be configured to move blood from the organic filter to the buffer reservoir. The treatment kit may include a return line. The return line may be operatively coupled to the buffer reservoir and the patient. The return line may be configured to move blood from the buffer reservoir to the patient. The treatment kit may include a leak line. The leak line can be operatively coupled to the buffer reservoir. The leak line can be configured to move fluid that leaks from the organic filter to the buffer reservoir.

[0008] An illustrative method may include monitoring at least one of an access pressure, an organic filter pressure, a return pressure, and a buffer reservoir weight of an extracorporeal blood treatment apparatus to perform extracorporeal blood treatment using an organic filter operable to perform a function of a human organ. The access pressure may be monitored using an access pressure sensor. The organic filter pressure may be monitored using an organic filter pressure sensor. The return pressure may be monitored using a return pressure sensor. The buffer reservoir weight may be monitored using a reservoir scale. The method may also include adjusting a pump speed of at least one of a first low-flow pump, a second low-flow pump, and a high-flow pump based on at least one of the monitored access pressure, the organic filter pressure, the return pressure, and the buffer reservoir weight.

[0009] An illustrative computer-readable medium is configured to monitor at least one of an access pressure, an organic filter pressure, a return pressure, and a buffer reservoir weight of an extracorporeal blood treatment apparatus, and an organic filter operable to perform a human organ function. The access pressure may be monitored using an access pressure sensor. The organic filter pressure may be monitored using an organic filter pressure sensor. The return pressure may be monitored using a return pressure sensor. The buffer reservoir weight may be monitored using a reservoir scale. The computer-readable medium may also be configured to adjust the pump speed of at least one of a first low-flow pump, a second low-flow pump, and a high-flow pump based on at least one of the monitored access pressure, the organic filter pressure, the return pressure, and the buffer reservoir weight.

[0010] An illustrative apparatus may include an apparatus for extracorporeal blood treatment using an organic filter operable to perform a function of a human organ. The apparatus may include a computing device operatively coupled to at least one pump. The computing device may be configured to perform the extracorporeal blood treatment by controlling the at least one pump.

[0011] An illustrative extracorporeal blood treatment apparatus may include a treatment kit. The treatment kit may include tubing. The treatment kit may be operatively coupled to a patient. The treatment kit may be configured to move blood from the patient to an organic filter. The organic filter may be operable to perform the function of a human organ. The treatment kit may be configured to return filtered blood to the patient. The treatment kit may include an access line. The access line may be operatively coupled to the patient and configured to receive blood from the patient. The treatment kit may include an organic filter inlet line. The organic filter inlet line may be operatively coupled to the access line and the organic filter. The organic filter inlet line may be configured to move blood from the access line to the organic filter. The treatment kit may include a return line. The return line may be operatively coupled to the patient and configured to return blood to the patient. The treatment kit may include a high-flow pump outlet line. The high-flow pump outlet line may be operatively coupled to at least one of the access line and the organic filter inlet line. The high-flow pump outlet line may be configured to move blood from the organic filter to at least one of the access line and the organic filter inlet line. The apparatus may further include a first low-flow pump. The first low-flow pump may be operatively coupled to the access line. The first low-flow pump may be configured to move blood from the patient through the treatment kit toward the organic filter. The apparatus may further include a second low-flow pump. The second low-flow pump may be operatively coupled to the return line. The second low-flow pump may be configured to move blood from the organic filter through the treatment kit toward the patient. The apparatus may further include a high-flow pump. The high-flow pump may be operatively coupled to the high-flow pump outlet line. The high-flow pump may be configured to move blood from the organic filter to at least one of the access line and the organic filter inlet line. The high-flow pump may be configured to move blood to the organic filter. The apparatus may include a computing device. The computing device may be operatively coupled to the pump. The computing device may be configured to control the first low-flow pump to move blood from the patient through the treatment kit toward the organic filter. The computing device may be configured to control the second low-flow pump to move blood from the organic filter through the treatment kit toward the patient. The computing device may be configured to control the high-flow pump to move blood from the organic filter to the access line or the organic filter inlet line. The computing device may be configured to move the blood to an organic filter.

[0012] Illustrative devices, apparatus, methods, and systems may be described as providing and facilitating methods for obtaining blood from a patient, supporting a defined pressure and blood flow rate to maintain viability of an organic filter, accounting for blood loss from the organic filter, and returning the blood to the patient. Specifically, the organic filter may require specific temperatures, blood flow rates, pressures, and oxygen levels to simulate its normal operating environment, and the illustrative devices or systems may be configured to provide many of these parameters outside the human body, for example, by using a combination of pumps to meet blood flow rates, using embedded pressure sensors to monitor and control pressure to the organic filter, using embedded pressure sensors to monitor and control blood access and blood return to the patient, and using embedded scales to monitor and control blood loss in the system.

[0013] The illustrative apparatus, devices, methods, and systems can generally be described as comprising two main elements, namely, a computing device (or control unit) and a disposable processing kit connected to the patient via central venous access. Blood can be drawn from the patient via an access line of the processing kit connected to the central venous access, then circulated through an oxygenator, an organic filter located within an organ chamber, and through a blood bag, with the purified blood then returned to the patient via a return line connected to the central venous access. In alternative embodiments, unfiltered blood is not drawn from the patient's vascular system, but rather from a storage container (e.g., a blood bag). The extracorporeal circuit defined by the processing kit may also have a recirculation loop within the circuit that circulates blood through the oxygenator and organic filter at a higher blood flow rate than that used when the blood was drawn from the patient. The oxygenator can be used to oxygenate the blood drawn from the patient's venous circulation before circulating the blood through the organic filter. The organic filter can remove toxins from the blood through adsorption before returning the blood to the patient.

[0014] The computing device or control unit can be configured to pump blood through the extracorporeal circuit using two of the system's peristaltic low-flow pumps. The blood flow rates of the two low-flow pumps can be set between 0 and 166 ml / min. The blood flow rates of the individual pumps can be manually adjusted by an operator or automatically adjusted by the computing device to maintain the amount of blood in the blood bag within a predetermined range. The computing device can also be configured to pump blood through a recirculation loop within the extracorporeal circuit using the system's peristaltic high-flow pump. The recirculation blood flow rate can be set between 0 and 450 ml / min.

[0015] The computing device can also be used to monitor, using one of the system's scales, that the amount of blood in a disposable kit's blood bag remains stable within specified limits. The blood bag can be hung on the scale, and the weight of the bag can be monitored based on a tare weight determined at the start of treatment. The blood bag can be used as a blood reservoir for a recirculation loop and collect any blood from the bottom of the organ chamber (e.g., fluid seeping from an organic filter).

[0016] The computing device can also be used to monitor the access pressure (36a), organic filter pressure (36b) and return pressure (36c) in the extracorporeal circuit, the liquid level in the degassing chamber (40), and to monitor bubbles in the return line using an ultrasonic air detector (42), and to prevent detected bubbles from reaching the patient using a return line clamp.

[0017] The disposable processing kit may have several sample ports placed at strategic locations throughout the extracorporeal circuit to enable blood sampling (38a-d).

[0018] The illustrative apparatus, device, method, and system can be described as having a treatment mode that supports extracorporeal liver assist product (ELAP) therapy and a disposable treatment kit. In ELAP therapy, anticoagulation of the extracorporeal circuit of the disposable treatment kit will be performed by infusing an anticoagulant solution using a syringe / infusion pump. In addition, the system can provide automatic loading of the disposable treatment kit using the system's automatic loading function. In addition, the disposable treatment kit can be identified by a barcode on the front and / or back of the disposable treatment kit and can be read by a system barcode reader.

[0019] Illustrative devices, apparatus, methods, and systems can provide a manual or automated priming procedure for a disposable processing set, wherein an operator may need to manually start and stop three blood pumps at specific flow rates to prime the extracorporeal circuit of the disposable processing set. Used perfusion solution can be collected in a separate collection bag that may not be monitored.

[0020] During ELAP therapy, the illustrative devices, apparatuses, methods, and systems can request a medical prescription via the following parameters: blood pump access (BP-Access) flow rate; blood pump return (BP-Return) flow rate; and blood pump organ (BP-Organ) flow rate. Furthermore, the illustrative apparatus or system can allow the blood pumps described above to achieve the following blood flow rates: blood pump access (peristaltic low-flow pump) blood flow rate of up to 166 ml / min; blood pump return (peristaltic low-flow pump) blood flow rate of up to 166 ml / min; and blood pump organ (peristaltic high-flow pump) blood flow rate of up to 450 ml / min.

[0021] The blood flow accuracy of all the above blood pumps can be less than ±10% at the highest blood flow rate that the user can set and at a fluid temperature of 37°C and an access pressure of -200 mmHg. Access pressure is defined as the pressure measured at the access pod in the blood withdrawal line of the extracorporeal circuit.

[0022] Illustrative devices, apparatuses, methods, and systems can monitor the pressure in the extracorporeal circuit of a disposable processing kit using the system's pressure sensors. The following pressures can be monitored: access pressure before the first low-flow blood pump (pump 1) monitored using an access pressure sensor (cabin-based); organ pressure before the organic filter in the organ chamber monitored using an organic filter pressure sensor (cabin-based); and return pressure at the top of the degassing chamber after the second low-flow blood pump (pump 2) monitored using a return pressure sensor. The pressure operating range and accuracy of the illustrative device or system can be as follows: access pressure measured within the range of -250 to +450 mmHg with an accuracy better than ±15 mmHg; return pressure measured within the range of -50 to +350 mmHg with an accuracy better than ±5 mmHg; and organ pressure measured within the range of -50 to +450 mmHg with an accuracy better than ±50 mmHg.

[0023] The above summary of the present disclosure is not intended to describe every embodiment or every implementation thereof. Advantages of the present disclosure and a more complete understanding of the present disclosure will become apparent and understandable by referring to the following detailed description and claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a block diagram of an illustrative extracorporeal blood treatment system including an input device, a display device, and an extracorporeal blood treatment apparatus that may utilize the systems and treatment kits described herein.

[0025] Figure 2 is a depiction of an illustrative extracorporeal blood processing apparatus including the computing device described herein.

[0026] Figure 3 is a schematic diagram of an illustrative fluid circuit that may be used by the extracorporeal processing systems and devices described herein to perform extracorporeal blood processing on a patient using an organic filter that is operable to perform the functions of a human organ.

[0027] Figure 4 is a depiction of an illustrative processing suite.

[0028] Figure 5 Is to use Figures 1 to 4 An illustrative method of an extracorporeal blood treatment apparatus or system is shown. DETAILED DESCRIPTION

[0029] In the following detailed description of illustrative embodiments, reference is made to the accompanying drawings, which form a part hereof, and show by way of illustration specific embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the disclosure set forth herein.

[0030] Will refer to Figures 1 to 5 Illustrative apparatus, devices, methods, systems, and treatment kits for extracorporeal blood processing for organ support are described. It will be apparent to those skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of other embodiments, and that possible embodiments of such systems and methods using the combinations of features set forth herein are not limited to the specific embodiments shown in the figures and / or described herein. Furthermore, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Furthermore, it will be appreciated that the timing of the processes herein and the sizes and shapes of the various elements may be modified and still fall within the scope of this disclosure, although certain timings, one or more shapes and / or sizes, or element types may be more advantageous than other timings, shapes, and / or sizes, or element types.

[0031] Illustrative apparatus, devices, methods, and systems include an extracorporeal blood treatment apparatus, which includes, for example, elements or components such as a pump, a tubing / processing kit, a reservoir, etc., for performing extracorporeal blood treatment on a patient using an organic filter that is operable to perform the function of a human organ. In some cases, the organic filter can be a liver organ, such as the one described herein. In at least one embodiment, the extracorporeal blood treatment apparatus may include, among other components: a processing kit, a high-flow pump, a first low-flow pump, and a second low-flow pump. The high-flow pump can be configured to pump fluid or liquid in the tubing or processing kit at a flow rate that is higher than that of the first low-flow pump and the second low-flow pump. In an alternative embodiment, contrary to the nomenclature, the high-flow pump can be configured to pump fluid at a flow rate that is equal to or lower than that of the first low-flow pump and the second low-flow pump. The nomenclature is not intended to limit absolute flow rates, but rather to distinguish between pumps.

[0032] The organic filter can effectively perform liver function using a minimum blood volume and / or minimum blood flow passing through it at any given moment. In other words, if the minimum blood volume and minimum blood flow are not maintained in the organic filter, the organic filter may not be able to effectively perform extracorporeal blood treatment.

[0033] Comprehensive organ reconstruction is extremely challenging, not least because of the extremely complex anatomy of organs. In some cases, pig organs can be used as a matrix for constructing human organs, in part because of the similarities in anatomy and vascular structure. Porcine organs can be decellularized to remove the pig cells, leaving behind a scaffolding extracellular matrix. This scaffold can then be recellularized, or populated with functional living human cells. For example, such human cells can be isolated from a donated human organ. The recellularized organoid liver can function like a normal human liver and, when used in human patients, could reduce the risk of rejection.

[0034] An example of an organic filter described herein may be a MIROMATRIX TM Perfusion decellularization and recellularization of porcine organs. An example of decellularization and recellularization of organs and tissues is shown in the following document: U.S. Patent Publication No. 2022 / 0062349A1, filed by Taylor et al. on August 4, 2021. Illustrative methods for using blood to augment human cells for transplantation on biocompatible scaffolds are shown in the following document: U.S. Patent No. 11,278,643B2, filed by Ross et al. on September 6, 2017. Illustrative methods for decellularization and recellularization of solid organs are shown in the following document: U.S. Patent Publication No. 2019 / 0343877A1, filed by Ott et al. on January 11, 2019. Illustrative methods for preparing transplants from recellularized mammalian livers are shown in the following document: U.S. Patent No. 11,452,797B2, filed by Jeffrey Ross on January 9, 2019. Illustrative methods for matched recellularization using perfused decellularized organs are described in European Patent No. 2,588,592 B2, filed by Jeffrey Ross on June 30, 2011. Illustrative systems and apparatus for the preliminary preparation of organ scaffolds to form artificial organs are described in U.S. Patent Publication No. 2010 / 0093066 A1, filed by Taylor et al. on August 25, 2009.

[0035] In alternative embodiments, the devices, apparatus, systems, and methods may instead be used for kidney support and utilize an organic filter operable to perform the function of a kidney organ. In alternative embodiments, the devices, apparatus, systems, and methods may instead be used for lung support and utilize an organic filter operable to perform the function of a lung organ.

[0036] To maintain a minimum volume and minimum flow rate for the organic filter, the illustrative apparatus and system utilize a buffer reservoir and multiple pumps that can be used together, as further described herein. The pumps include a high-flow pump and two low-flow pumps. The output of one of the low-flow pumps and the output of the high-flow pump are combined to provide the minimum flow rate for the organic filter. The buffer reservoir, which can be a hanging blood bag, can be used to ensure that there is enough blood in the system or treatment kit to meet the minimum volume and / or flow rate for the organic filter. In other words, the pump and buffer reservoir configured as described herein can ensure that there is enough blood flowing to exceed the minimum flow rate for the organic filter and that there is enough blood to exceed the minimum volume in the organic filter, as used by the organic filter.

[0037] In addition, the illustrative device or system can be controllable to maintain or control the pressure at certain locations in the pipeline or processing kit, for example, the access pressure close to the patient when blood is extracted from the patient or storage container, the return pressure close to the patient when filtered blood is returned to the patient, or the organic filter pressure close to the organic filter. For example, the system can include a computing device that can control a high-flow pump, a first low-flow pump, and a second low-flow pump to control pressure, as further discussed herein. In addition, the computing device can maintain or control the weight of various components (e.g., a buffer reservoir). In addition, the computing device can control a high-flow pump, a first low-flow pump, and a second low-flow pump to control weight, as discussed herein. In addition, the computing device can maintain or control the desired flow of the pump, or maintain or control the amount of substances or toxins in the blood.

[0038] The flow rates of fluids in a system or treatment kit can be adjusted. The flow rate of each fluid can be limited (e.g., upper and lower flow rates) based on a number of factors, including, but not limited to, other flow rates in the extracorporeal blood treatment system, pressures at various locations in the treatment kit, the weight of various components of the system, etc. When a selected flow rate is adjusted to a limit or a limit is reached, the exemplary system can, for example, provide a notification to the user to adjust or modify the flow rate or to pause the extracorporeal blood treatment.

[0039] Figure 1 The illustrative extracorporeal blood processing system 10 depicted in FIG can be used to perform or implement the exemplary methods and / or processes described herein. In at least one embodiment, the system 10 can be a machine for extracorporeal treatment of blood. For example, the system 10 can also be a blood processing device, a blood component preparation device, or other medical device for fluid transfer / collection.

[0040] As shown, the exemplary extracorporeal blood treatment system 10 includes a computing device 12. The computing device 12 can be configured to receive input from an input device 20 and transmit output to a display device 22. In addition, the computing device 12 can include a data store 14. The data store 14 can allow access to processing programs or routines 16 and one or more other types of data 18 that can be used to perform exemplary methods and / or processes (e.g., measuring pressure, synchronizing pumps, weighing reservoirs, adjusting treatments, adjusting flow rates, calculating flow rates, determining flow rates based on other flow rates, running treatments, notifying an operator or user of problems, displaying status information, etc.) for performing extracorporeal blood treatment. For example, the computing device 12 can be configured to display an exemplary graphical user interface displayed by the display device 22, the exemplary graphical user interface including a treatment kit having one or more fluid lines, various pumps described herein, flow rates or pressures within the treatment kit, weights of various components, etc.

[0041] The computing device 12 can be operatively coupled to the input device 20 and the display device 22 to, for example, transmit data to and from each of the input device 20 and the display device 22. For example, the computing device 12 can be electrically coupled to each of the input device 20 and the display device 22 using, for example, an analog electrical connection, a digital electrical connection, a wireless connection, a bus-based connection, etc. For example, an operator can provide input to the input device 20 to manipulate or modify one or more graphical depictions displayed on the display device 22 to select and adjust one or more flow rates, pressures, weights, etc., during, before, or after any extracorporeal blood treatment.

[0042] In addition, various devices and apparatuses can be operatively coupled to the computing device 12 for use with the computing device 12 to perform one or more in vitro programs / processes and the functions, methods, and / or logic described herein. As shown, the system 10 can include an input device 20, a display device 22, and a processing device 24 operatively coupled to the computing device 12 (e.g., such that the computing device 12 can be configured to use information or data from the devices 20, 22, 24 and to provide information or data to the devices 20, 22, 24). The input device 20 can include any device capable of providing input to the computing device 12 to perform the functions, methods, and / or logic described herein.

[0043] For example, the input device 20 may include a touch screen (e.g., a capacitive touch screen, a resistive touch screen, a multi-touch screen, etc.), a mouse, a keyboard, a trackball, etc. The touch screen may be superimposed on the display device 22 so that, for example, an operator can use the touch screen to interact with a graphical user interface displayed on the display device (e.g., by touching it). When used in conjunction with the display device 22 (e.g., displaying a graphical user interface), the input device 20 may allow an operator to interact with a graphical user interface that includes a process kit having one or more fluid lines, various pumps described herein, flow rates or pressures within the process kit, weights of various components, etc.

[0044] The display device 22 may include any device capable of displaying information to an operator (such as a graphical user interface, etc.) to perform the functions, methods, and / or logic described herein. For example, the display device 22 may include a liquid crystal display, an organic light emitting diode screen, a touch screen, a cathode ray tube display, etc. As further described herein, the graphical user interface displayed by the display device 22 may include a plurality of items related to extracorporeal blood processing, such as a processing kit having one or more fluid lines, various pumps described herein, flow rates or pressures within the processing kit, weights of various components, etc. In addition, the user may use or interact with each of these components to change or modify one or more parameters associated with the fluid within the processing kit, such as flow rates, pressures, concentrations, etc.

[0045] The processing programs or routines 16 may include programs or routines for performing computational mathematics, matrix mathematics, normalization algorithms, comparison algorithms, or any other processing required to implement one or more of the exemplary methods and / or processes described herein. For example, the data 18 may include organic filter limits, fluid data, flow rates, fluid volumes, notifications, pressures, blood flow rates, fluid removal rates, target blood temperatures, graphics (e.g., graphical elements, icons, buttons, windows, dialog boxes, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results of one or more processing programs or routines employed in accordance with the present disclosure, or any other data required to perform one and / or more processes or methods described herein.

[0046] In one or more embodiments, system 10 can be implemented using one or more computer programs executed on a programmable computer (such as a computer that includes, for example, processing capabilities, data storage (e.g., volatile or non-volatile memory and / or storage elements), input devices, and output devices. The program code and / or logic described herein can be applied to input data to perform the functions described herein and generate desired output information. The output information can be applied as input to one or more other devices and / or methods described herein, or applied in a known manner.

[0047] The program for implementing the method and / or process described herein can be provided using any programming language, for example, a high-level procedural programming language and / or an object-oriented programming language suitable for communicating with a computer system. Any such program can be, for example, stored on any suitable device (e.g., a storage medium), which can be read by a general-purpose program or a special-purpose program running on a computer system (e.g., including a processing device), and the general-purpose program or special-purpose program is used to configure and operate the computer system when a suitable device is read to execute the program described herein. In other words, in at least one embodiment, system 10 can be implemented using a computer-readable storage medium configured with a computer program, wherein the storage medium configured in this manner enables the computer to operate in a specific and predefined manner to perform the functions described herein. In addition, in at least one embodiment, system 10 can be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media, the logic including a code for execution, which is operable when executed by a processor to perform the operations described herein (e.g., methods, processes, and / or functions).

[0048] Likewise, the system 10 may be configured at a remote site (e.g., an application server) that allows access by one or more operators or users via a remote computer device (e.g., via a web browser) and allows the operators to employ functionality according to the present disclosure (e.g., the operators access a graphical user interface associated with one or more programs to process data).

[0049] For example, the computing device 12 may be any fixed or mobile computer system (e.g., a controller, a microcontroller, a personal computer, a minicomputer, etc.). The exact configuration of the computing device 12 is not limited, and essentially any device that can provide suitable computing power and control capabilities (e.g., graphics processing, control of an extracorporeal blood treatment device, etc.) may be used.

[0050] As described herein, a digital file can be any medium (e.g., volatile or non-volatile memory, CD-ROM, punched cards, recordable tape, etc.) containing digital bits (e.g., encoded in binary, ternary, etc.) that can be read and / or written by computing device 12 as described herein. Furthermore, as described herein, a file in a user-readable format can be any data representation (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphics, etc.) that can be presented on any user-readable and / or understandable medium (e.g., paper, a display, etc.).

[0051] In view of the above, it is apparent that the functions described in one or more embodiments of the present disclosure can be implemented in any manner known to those skilled in the art. Therefore, the computer language, computer system, or any other software / hardware used to implement the processes described herein should not limit the scope of the systems, processes, or programs described herein (e.g., the functions provided by such systems, processes, or programs).

[0052] The methods and / or logic described in this disclosure (including methods and / or logic attributed to the system or various constituent components) may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the technology may be implemented in one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, as well as any combination of such components or other devices. The term "processor" or "processing circuitry" may generally refer to any of the aforementioned logic circuits (used alone or in combination with other logic circuits) or any other equivalent circuitry.

[0053] Such hardware, software, and / or firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described components may be implemented together or individually as separate but interoperable logic devices. The depiction of different features, such as using block diagrams, is intended to highlight different functional aspects and does not necessarily imply that such features must be implemented by separate hardware or software components. Rather, functions may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

[0054] When implemented in software, the functions of the systems, devices, and methods described in this disclosure may be embodied as instructions and / or logic on a computer-readable medium (e.g., RAM, ROM, NVRAM, EEPROM, flash memory, magnetic data storage media, optical data storage media, etc.). These instructions and / or logic may be executed by one or more processors to support one or more aspects of the functions described in this disclosure.

[0055] The processing device 24 may include any element or component used in an exemplary extracorporeal blood processing system capable of performing extracorporeal blood processing, such as, for example, a pump, a reservoir, a scale, tubing, or a processing kit, a filter, a pressure sensor, etc. For example, the processing device 24 may include any element or component used in an exemplary extracorporeal blood processing system capable of performing extracorporeal blood processing, such as, for example, a pump, a reservoir, a scale, tubing, or a processing kit, a filter, a pressure sensor, etc. Figure 2 One or more elements or components of the extracorporeal blood treatment system 100 are described.

[0056] The illustrative devices, systems, and methods performed or used by such systems described herein may generally be referred to as organ support systems. For example, the systems, devices, and apparatus may be capable of performing dialysis or other procedures or methods. The general term "dialysis" as used herein includes hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion, liver dialysis, and therapeutic plasma exchange (TPE), as well as other similar treatment procedures. Generally, in dialysis, blood is withdrawn from the body and exposed to a treatment apparatus to separate substances from and / or add substances to the blood, and then returned to the body. Although this document will refer to Figure 2 The illustrative extracorporeal blood processing system described herein is used to describe an extracorporeal blood processing system capable of performing general dialysis (including TPE, as described above), but other systems (e.g., systems for infusing drugs, performing continuous renal replacement therapy (CRRT), extracorporeal membrane oxygenation (ECMO), hemoperfusion, liver dialysis, blood separation, TPE, etc.) can benefit from the systems, methods, and devices described herein, and the present disclosure is not limited to any particular fluid processing system.

[0057] refer to Figure 2 , depicts an illustrative embodiment of an extracorporeal blood treatment system or apparatus 100. System 100 includes a housing 110 having a front face 112. The system also includes one or more pumps 120 for moving liquid through the apparatus as part of a treatment process. Although pump 120 is depicted in the form of a peristaltic pump, the pumps used in the extracorporeal blood treatment systems described herein can be provided in various alternative forms (e.g., piston pumps, pumps for use with syringes, diaphragm pumps, etc.).

[0058] In one or more embodiments, the extracorporeal blood treatment system 100 further includes a display 160 for conveying information to an operator. If the display 160 is in the form of a touch screen, for example, the display 160 can also be used as an input device. Furthermore, although the display 160 is depicted as being located within the housing 110, in one or more alternative embodiments, the display 160 can be separate from the housing 110 of the extracorporeal blood treatment system 100. For example, the display 160 can be movably attached or coupled to the housing 110 (e.g., rotatable, tiltable, etc.).

[0059] The extracorporeal blood treatment system 100 may also include reservoir scales 130, each of which is configured to hold and weigh a reservoir 132. The reservoir scales 130 are positioned below the bottom end 114 of the housing 110, at least in part because the reservoirs 132 are typically attached to and suspended from the reservoir scales 130. Although the depicted embodiment of the extracorporeal blood treatment system 100 includes four reservoir scales 130 and associated reservoirs 132, alternative embodiments of the extracorporeal blood treatment apparatus described herein may include one or more reservoir scales 130 and associated reservoirs 132, such as, for example, as few as one reservoir scale 130 and associated reservoir 132, four or more reservoir scales 130 and associated reservoirs 132, and the like.

[0060] In the illustrated embodiment, the reservoir 132 can take the form of, for example, a flexible polymer bag configured to hold a liquid. However, the reservoir 132 used in conjunction with the exemplary extracorporeal blood processing systems described herein can take any suitable form (e.g., a bottle, a can, a box, a syringe, a jug, etc.) in which the liquid can be stored and weighed by any scale or weighing device (e.g., such as the reservoir scale 130).

[0061] In such Figure 3 In the illustrative embodiment for performing extracorporeal blood treatment diagrammatically depicted in , the system may use only a single reservoir, which is a buffer reservoir configured to hold a buffer of blood to meet the flow rate and volume minimums used by the organic filter to maintain its function.

[0062] like Figure 1 shown, and with Figure 2 Relatedly, the processing device 24 may be operatively coupled or connected to the computing device 12. The processing device 24 operatively coupled to the computing device 12 includes the following: Figure 2 Shown are a pump 120 and a reservoir scale 130. Each of the pump 120 and reservoir 132 may have a flow rate associated therewith.

[0063] In one or more embodiments, computing device 12 may be configured to receive a weight signal from each reservoir scale 130, wherein the weight signal from each reservoir scale 130 indicates the weight of a reservoir 132 attached to the reservoir scale 130. Computing device 12 may also be configured to determine, based at least in part on the weight signal received from the reservoir scale 130, that a reservoir 132 attached to the reservoir scale 130 from which the weight signal was received has risen or fallen beyond a selected weight limit.

[0064] Figure 3An illustrative fluid circuit and arrangement of an extracorporeal blood treatment apparatus is depicted in FIG, which may be used by the extracorporeal blood treatment systems and apparatus described herein to perform extracorporeal blood treatment on a patient using an organic filter operable to perform the function of a human organ. Figure 4 An illustrative processing kit is depicted in FIG. This illustrative arrangement of fluid circuits and extracorporeal blood processing apparatus and processing kit may be used with Figure 2 Extracorporeal treatment devices and Figure 1 As shown in the exemplary drawings, blood treatment can be performed or implemented by an exemplary extracorporeal blood treatment system, so the treatment device 24A (such as Figure 3 ) is configured to diagrammatically represent an exemplary physical extracorporeal fluid circuit for blood processing. Figures 3 to 5 The fluid lines corresponding to an exemplary blood treatment are depicted in FIG. Furthermore, blood treatment can last up to 72 hours at a time.

[0065] Figure 3 In the figure, an exemplary treatment device 24A is depicted, which can generally be used during extracorporeal blood treatment using an organic filter and / or for extracorporeal blood treatment using an organic filter. Treatment device 24A can include a treatment kit 50 (which includes piping, such as piping lines 52a-f as shown in the figure), which forms or defines a fluid circuit, wherein treatment device 24A is configured to diagrammatically represent a physical extracorporeal fluid circuit for the extracorporeal blood treatment performed using an organic filter by an exemplary extracorporeal blood treatment system. Treatment kit 50 is indicated by arrows connecting various components. Treatment kit 50 is operatively coupled to patient 34 to move blood from patient 34 to organic filter 30 and return filtered blood to patient 34. Treatment kit 50 is at least operatively coupled to organic filter 30, buffer reservoir 32 and patient 34.

[0066] The processing kit 50 may also include one or more tubing lines or segments 52a-f (collectively, 52) extending between and connecting the various components of the exemplary fluid circuit. The various components of the exemplary fluid circuit include an organic filter 30, a buffer reservoir 32, a patient 34, one or more pressure sensors 36a-c (collectively, 36), one or more sample ports 38a-d (collectively, 38), a degassing chamber 40, an air detector 42, a return tubing clamp 46, an oxygenator 44, a first low-flow pump P1, a second low-flow pump P2, and a high-flow pump P3. The direction of fluid flow through the processing kit 50 is depicted using the direction of the arrows. Each of the tubing lines 52 and each individual segment of each tubing line between adjacent components and each component can correspond to a fluid, flow rate or pump rate, pressure, and / or fluid concentration in a physical fluid circuit used in the exemplary extracorporeal blood treatment.

[0067] In addition, the processing kit 50 is operatively coupled to the patient 34, the organic filter 30, and the buffer reservoir 32. Such operative couplings may include, for example, an intravenous access needle, catheter, or tubing. The processing kit 50 is also operatively coupled to the components of the processing device 24A discussed herein, and such operative couplings may include, for example, access ports or other mechanical couplings. The processing device 24A is sterile because it is configured for use in a medical environment.

[0068] The processing kit 50 and various components can provide the following fluid circuit path. For example, the processing kit 50 includes an access line 52a, which is operatively coupled to the patient 34 and is configured to receive a fluid (e.g., whole blood) from the patient 34. A first low-flow pump P1 can be used to draw blood from the patient 34, and the blood can flow through the access pressure sensor 36a and through the first sample port 38a. Therefore, the first low-flow pump P1 can move blood from the patient 34 through the processing kit toward the organic filter 30. The access pressure sensor 36a can be configured to sense the access pressure of the blood downstream of the patient access site (the position where the processing kit 50 is operatively coupled to the patient 34) in the processing kit 50. In one or more embodiments, the first sample port 38a is positioned downstream of the access pressure sensor 36a.

[0069] Each of the sample ports 38 can be configured to remove a sample of fluid (e.g., blood) from the fluid in the processing kit 50. The sample can be tested for various variables and substances (e.g., ammonia, toxins, blood cell count, etc.). For example, samples can be taken upstream and downstream of the organic filter 30 to detect ammonia in the blood to determine whether the organic filter 30 is successfully filtering ammonia from the blood.

[0070] The processing kit 50 also includes a buffer reservoir line 52g, which is operatively coupled to the buffer reservoir and configured to receive fluid (e.g., whole blood) from the buffer reservoir. A high-flow pump P3 can be used to draw blood from the buffer reservoir 32. Thus, the high-flow pump P3 can move the blood through the processing kit (including the buffer reservoir line 52g, the high-flow pump inlet line 52h, and the high-flow pump outlet line 52b) to the organic filter 30. The fluids pumped through the access line 52a and the high-flow pump outlet line 52b using the high-flow pump P3 and the first low-flow pump P1, respectively, can be combined, as shown in FIG. Figure 3 This combined flow rate may be described as the "organic filter inlet flow rate." The processing kit 50 also includes a high flow pump inlet line 52h that operatively couples the buffer reservoir line 52g to the high flow pump P3.

[0071] The processing kit also includes an organic filter inlet line 52c that is operatively coupled to the access line 52a, the buffer reservoir line 52g (via the high flow pump inlet line 52h and the high flow pump outlet line 52b), and the organic filter 30, and is configured to move blood from the access line 52a and the buffer reservoir line 52g (via the high flow pump inlet line 52h and the high flow pump outlet line 52b) to the organic filter 30. This combined organic filter inlet flow allows the patient 34 to experience a lower flow rate of blood removed from the patient 34, which may be safer or more comfortable for the patient 34. The combined organic filter inlet flow will be discussed further herein.

[0072] In alternative embodiments, unfiltered blood is not drawn from the patient's vascular system, but rather from a storage container (e.g., a blood bag). In these alternative embodiments, for example, there is less risk of extracting blood too quickly from the storage container (compared to extracting blood from the patient), and therefore a buffer reservoir may not be required. In addition, for example, the first low-flow pump can be configured to pump at a higher speed, while a high-flow pump may not be necessary. In addition, contrary to the nomenclature, the first low-flow pump and the second low-flow pump can be configured to pump fluid at a higher flow rate than the high-flow pump. The nomenclature is not used to limit in terms of absolute flow rate, but rather to distinguish between pumps.

[0073] The organic filter inlet flow can move through the oxygenator 44, through the second sample port 38b, through the organic filter pressure sensor 36b, and then into the organic filter 30. The oxygenator 44 can be configured to oxygenate the fluid within the processing kit 50. The oxygenator 44 can be positioned downstream of the high-flow pump P3 and the first low-flow pump P1, and can be positioned upstream of the organic filter 30. The organic filter pressure sensor 36b can be configured to sense the organic filter pressure of the blood within the processing kit 50 upstream of the organic filter 30. The second sample port 38b can be positioned upstream of the organic filter pressure sensor 36b.

[0074] The organic filter 30 can be a liver organ, such as a human liver or a pig liver that has been decellularized and subsequently recellularized using human cells, as described herein. The organic filter 30 can be a kidney organ, such as a human kidney or a pig kidney, etc. The organic filter 30 can be one or more lungs, such as a human lung or a pig lung, etc. The organic filter 30 can operate normally using a certain amount of blood flowing through it at a certain flow rate. For example, a human liver can hold about one pint of blood at any given time and can filter blood at a rate of 1.7 liters per minute. In the event that the amount of blood and the blood flow rate entering and passing through the organic filter 30 are not appropriate, the organic filter 30 may not operate properly or may be damaged. To prevent this, the extracorporeal blood treatment system 10 can be configured to control the amount and rate of blood flowing into and through the organic filter 30 during the treatment process.

[0075] Once the blood has moved through the organic filter 30, the blood exits the organic filter 30 and enters an organic filter outlet line 52d operatively coupled to the organic filter and the buffer reservoir. The organic filter outlet line 52d can be configured to move the blood from the organic filter 30 to the buffer reservoir 32. Fluid exiting the organic filter 30 can move through the third sample port 38c and into the buffer reservoir 32.

[0076] The organic filter 30 can be located in a container or basin (e.g., a sealed container or basin). The organic filter 30 may leak or leak some blood or other fluids during operation, and therefore, the container may include a drain portion so that the leaked blood or fluid or the leaked blood or fluid can be recovered. Therefore, the processing kit 50 may include a runoff line 52f, which is operatively coupled to the drain portion of the container and the buffer reservoir 32 so as to move the fluid that has leaked from the organic filter to the buffer reservoir 32. In other words, the runoff line 52f drains any fluid that has leaked from the organic filter 30 into the buffer reservoir 32. In an alternative embodiment, this drainage can be gravity-driven, or can be pump-driven. The runoff fluid can include any fluid that is discharged from the organic filter during the treatment process and does not flow through the organic filter outlet line 52d.

[0077] The processing kit 50 also includes a return line 52e that is operatively coupled to the buffer reservoir 32 (via the buffer reservoir line 52g) and the patient 34 and is configured to move blood from the buffer reservoir 32 to the patient 34. Thus, the buffer reservoir line 52g can be operatively coupled to the return line 52e, as shown in FIG. Figure 3 As shown. A second low-flow pump P2 is used to pump fluid from the buffer reservoir 32 and move the fluid through the fourth sample port 38d, the return pressure sensor 36c, the degassing chamber 40, the air detector 42, and the return tubing clamp 46, and then back to the patient 34. Thus, the second low-flow pump P2 can move blood from the organic filter 30 through the processing kit to the patient 34. The second low-flow pump P2 can be configured to return blood from the organic filter 30 to the patient 34 at a second low flow rate.

[0078] The return pressure sensor 36c can be configured to sense the return pressure of blood within the treatment kit 50 near the patient return site (the location at which the treatment kit 50 is operably coupled to the patient 34). The fourth sample port 38d can be positioned upstream of the return pressure sensor 36c. The degassing chamber 40 can be positioned downstream of the return pressure sensor. The air detector 42 can be positioned downstream of the degassing chamber 40. The return tubing clamp 46 can be positioned downstream of the air detector 42. Other configurations and locations of the various components can be configured to perform the same or similar functions as discussed herein.

[0079] When the air detector 42 detects the presence of air within the fluid in the treatment kit 50, the computing device 12 can be configured to stop the first low-flow pump P1 and the second low-flow pump P2 and close the return line clamp 46. The computing device 12 can also be configured to stop the high-flow pump P3 as needed, or can be configured to continue using the high-flow pump P3, for example, to prevent clotting. Introducing air into the venous system of the patient 34 can be dangerous and life-threatening, and this safety measure can prevent such danger. In an alternative embodiment, the air detector 42 can detect bubbles of a minimum size to prevent such danger.

[0080] like Figure 3 As shown, the processing device 24A also includes a buffer reservoir 32 coupled to the processing kit 50. For example, Figure 3 As shown, one of the fluid connections to the buffer reservoir 32 is shown extending from the organic filter 30 to the buffer reservoir 32, which can indicate that the buffer reservoir 32 stores and collects fluid (e.g., fluid from a patient, etc.). Additionally, in other areas of the processing device 24A, fluid connections can be shown extending from the buffer reservoir 32 to a high flow pump P3 and a second low flow pump P2, which can indicate that the reservoir stores and supplies fluid to be used during blood processing. The buffer reservoir 32 can correspond to a physical reservoir, such as the one described herein. Figure 2 One of the reservoirs 132 of the extracorporeal blood treatment system 100 is depicted. The reservoir 132 may be a fluid bag as shown, or may be, for example, a cylindrical container, a canister, a syringe, a flask, or the like.

[0081] In this configuration as shown, computing device 12 can control processing device 24A so that buffer reservoir 34 is partially or completely filled to accommodate a buffer volume of fluid (e.g., blood) before extracorporeal blood treatment. For example, buffer reservoir 32 can be filled with 1 liter of blood from patient 34 and / or a non-patient blood supply for extracorporeal blood treatment. Furthermore, for example, buffer reservoir 32 can be filled with filtered patient blood or with filtered non-patient blood.

[0082] The buffer reservoir 32 can be configured to contain or hold between 0 and 5 liters of blood. During the illustrative process, the buffer reservoir 32 can be filled to contain 1 liter of blood. In other embodiments, during the illustrative process, the buffer reservoir 32 can be filled to contain greater than or equal to 0.25 liters of blood, greater than or equal to 0.5 liters of blood, greater than or equal to 0.75 liters of blood, greater than or equal to 1 liter of blood, greater than or equal to 1.25 liters of blood, greater than or equal to 1.5 liters of blood, etc., and / or less than or equal to 5 liters of blood, less than or equal to 3 liters of blood, less than or equal to 2 liters of blood, less than or equal to 1.5 liters of blood, less than or equal to 1.175 liters of blood, less than or equal to 0.95 liter of blood, etc.

[0083] In order to provide safe and comfortable treatment for the patient, blood may be drawn from the patient 34 at a slower rate than that required by the organic filter 30. The computing device 12 may also control the processing device 24A to move blood from the buffer reservoir 32 to the organic filter 30 at a high flow rate using the high flow pump P3 and to move blood from the patient 34 to the organic filter 30 at a first low flow rate using the first low flow pump P1. Figure 3 As shown, the fluid circuit can use a first low-flow pump P1 to promote blood flow from the patient 34, and the fluid circuit can use a high-flow pump P3 to promote blood flow from the buffer reservoir 32, and merge these blood flows toward the organic filter 30. Therefore, the high flow rate and the first low flow rate are merged into a combined flow rate (controlled by the computing device 12), and the combined flow rate is configured to move a sufficient amount of blood to the organic filter 30 at a sufficient flow rate to promote the function of the organic filter.

[0084] In one or more embodiments, the first low-flow pump P1 can be configured to move blood from the patient 34 to the organic filter 30 at a first low flow rate, while the second low-flow pump P2 can be configured to return blood from the organic filter 30 to the patient 34 at a second low flow rate. Furthermore, the first low flow rate can be equal to the second low flow rate. This can help ensure that fluid drawn from the patient 34 is replaced by an equal amount of fluid returned to the patient 34.

[0085] The first low flow rate can be between about 50 ml / min and about 170 ml / min. In at least one embodiment, the first low flow rate is 166 ml / min. In at least one embodiment, the first low flow rate can be greater than or equal to 50 ml / min, greater than or equal to 100 ml / min, greater than or equal to 125 ml / min, greater than or equal to 150 ml / min, and / or less than or equal to 175 ml / min, less than or equal to 160 ml / min, less than or equal to 140 ml / min, less than or equal to 110 ml / min, less than or equal to 85 ml / min, etc.

[0086] The high flow rate can be between about 200 milliliters per minute and about 500 milliliters per minute. In at least one embodiment, the high flow rate is 440 milliliters per minute. In at least one embodiment, the high flow rate is 184 milliliters per minute. In at least one embodiment, the high flow rate can be greater than or equal to 200 milliliters per minute, greater than or equal to 250 milliliters per minute, greater than or equal to 300 milliliters per minute, greater than or equal to 400 milliliters per minute, greater than or equal to 450 milliliters per minute, etc., and / or less than or equal to 475 milliliters per minute, less than or equal to 425 milliliters per minute, less than or equal to 375 milliliters per minute, less than or equal to 325 milliliters per minute, etc.

[0087] The second low flow rate can be between about 50 ml / min and about 170 ml / min. In at least one embodiment, the second low flow rate is 166 ml / min. In at least one embodiment, the second low flow rate can be greater than or equal to 50 ml / min, greater than or equal to 100 ml / min, greater than or equal to 125 ml / min, greater than or equal to 150 ml / min, and / or less than or equal to 175 ml / min, less than or equal to 160 ml / min, less than or equal to 140 ml / min, less than or equal to 110 ml / min, less than or equal to 85 ml / min, etc.

[0088] Computing device 12 (such as Figure 1 ) can be operatively coupled to an extracorporeal blood treatment apparatus 24, 24A (as shown Figures 1 to 3 ). Computing device 12 can be configured to perform extracorporeal blood treatment on patient 34 using extracorporeal blood treatment device 24 and organic filter 30. As described herein, computing device 12 can direct fluid flow through treatment kit 50 using pumps (P1-P3) to remove blood from patient 34, move the blood through organic filter 30, and return the blood to patient 34.

[0089] The computing device 12 may also be configured to utilize a first low-flow pump P1 to draw blood from the patient 34 toward the organic filter 30 at a first low flow rate. The computing device 12 may also be configured to utilize a second low-flow pump P2 to return blood from the organic filter 30 to the patient 34 at a second low flow rate. The computing device 12 may also be configured to utilize a high-low-flow pump P3 to draw blood from the buffer reservoir 32 toward the organic filter 30 at a high flow rate.

[0090] The computing device 12 can also be configured to control the high flow, the first low flow, and the second low flow based on at least one of the access pressure, the organic filter pressure, and the return pressure. The computing device 12 can also be configured to use at least one of the high flow pump P3, the first low flow pump P1, and the second low flow pump P2 to maintain the access pressure within the access pressure limit, maintain the organic pressure within the organic filter pressure limit, and / or maintain the return pressure within the return pressure limit. In one or more embodiments, the organic filter pressure limit is greater than the return pressure limit and the access pressure limit. In one or more embodiments, the organic filter pressure limit is less than the return pressure limit and the access pressure limit. If any corresponding pressure limit is reached, the pump is controlled to stop and no fluid moves through the treatment device 24A.

[0091] The access pressure limit may be between approximately -250 mmHg and 400 mmHg. In at least one embodiment, the access pressure limit is -200 mmHg. In at least one embodiment, the access pressure limit is greater than or equal to -100 mmHg, greater than or equal to 0 mmHg, greater than or equal to 50 mmHg, greater than or equal to 25 mmHg, greater than or equal to 75 mmHg, greater than or equal to 100 mmHg, greater than or equal to 150 mmHg, greater than or equal to 200 mmHg, greater than or equal to 250 mmHg, greater than or equal to 300 mmHg, greater than or equal to 400 mmHg, and / or less than or equal to 375 mmHg, less than or equal to 275 mmHg, less than or equal to 175 mmHg, less than or equal to 90 mmHg, less than or equal to 45 mmHg, less than or equal to -80 mmHg, etc.

[0092] The organic filter pressure limit may be between approximately 0 mmHg and 450 mmHg. In at least one embodiment, the organic filter pressure limit is 55 mmHg. In at least one embodiment, the organic filter pressure limit is greater than or equal to 0 mmHg, greater than or equal to 50 mmHg, greater than or equal to 25 mmHg, greater than or equal to 75 mmHg, greater than or equal to 100 mmHg, greater than or equal to 150 mmHg, greater than or equal to 200 mmHg, greater than or equal to 250 mmHg, greater than or equal to 300 mmHg, greater than or equal to 400 mmHg, greater than or equal to 450 mmHg, and / or less than or equal to 475 mmHg, less than or equal to 375 mmHg, less than or equal to 275 mmHg, less than or equal to 175 mmHg, less than or equal to 90 mmHg, less than or equal to 45 mmHg, etc.

[0093] The return pressure limit can be between approximately 0 mmHg and 300 mmHg. In at least one embodiment, the return pressure limit is 200 mmHg. In at least one embodiment, the return pressure limit is greater than or equal to 0 mmHg, greater than or equal to 50 mmHg, greater than or equal to 25 mmHg, greater than or equal to 75 mmHg, greater than or equal to 100 mmHg, greater than or equal to 150 mmHg, greater than or equal to 200 mmHg, greater than or equal to 250 mmHg, greater than or equal to 300 mmHg, and / or less than or equal to 375 mmHg, less than or equal to 275 mmHg, less than or equal to 175 mmHg, less than or equal to 90 mmHg, less than or equal to 45 mmHg, etc.

[0094] The processing device 24, 24A may also include a scale for weighing the buffer reservoir 32 (e.g., Figure 2130 shown). The computing device 12 may also be configured to maintain the weight of the buffer reservoir 32 using at least one of the high-flow pump P3, the first low-flow pump P1, and the second low-flow pump P2. In an alternative embodiment, the computing device 12 may use the pumps P1-P3 to maintain the weight of the buffer reservoir 32 within a certain range. The range may be based on the initial weight of the buffer reservoir 32 and may be based on a set value or a percentage of the initial weight of the buffer reservoir 32. If the weight of the buffer reservoir 32 is not maintained, the pump may be stopped so that no fluid moves through the processing device 24A.

[0095] The flow rates of pumps P1-P3 may vary depending on the process and / or stage in the process and may be changed or modified by the operator. Figure 1 The exemplary extracorporeal blood treatment system 10 is described as including an input device 20 for selecting one or more portions of a graphical user interface 200, such as, for example, regions, areas, elements, items, icons, buttons, and the like. For example, the input device 20 may be a touch screen corresponding to the graphical user interface 200. As used herein, when an operator refers to "selecting" a portion of the graphical user interface, it should be understood that the portion may be selected in many different ways using many different types of input devices. For example, when the input device is a touch screen, the operator may select the portion by "touching" the portion with their finger or using a pointing device such as a stylus.

[0096] When the operator adjusts the flow rate of a particular pump, one or more adjustment notifications may be depicted or displayed. In one or more embodiments, if one pump flow rate can be adjusted to maintain or obtain a desired variable (e.g., flow rate, pressure, weight), the exemplary system may automatically adjust the flow rate of another pump in pumps P1-P2. In other words, one flow rate may be dependent on another flow rate. In addition, in one or more embodiments, one or more flow rates of one pump in pumps P1-P3 may be automatically adjusted based on monitored variables (e.g., pressure, weight, etc.) without user intervention.

[0097] Figure 4 Other exemplary processing devices or exemplary processing kits 25 are depicted in FIG. Such exemplary processing devices or processing kits 25 may be used with Figure 2 Extracorporeal treatment device or Figure 1 Used in conjunction with an in vitro treatment system. Figure 3Similar to the processing device 24A described in , the processing kit 25 includes an access line 52a, which is operatively coupled to a patient (not shown) and is configured to receive blood from the patient. The processing kit 25 includes a buffer reservoir line 52g, which is operatively coupled to a buffer reservoir (not shown) and is configured to receive blood from the buffer reservoir. The processing kit 25 includes a high-flow pump inlet line 52h, which is operatively coupled to the buffer reservoir line 52g and the high-flow pump P3. The processing kit 25 includes a high-flow pump outlet line 52b, which is operatively coupled to the high-flow pump P3 and the access line 52a. The processing kit 25 includes an organic filter inlet line 52c, which is operatively coupled to the access line 52a, the buffer reservoir line 52g (via the high-flow pump inlet line 52h and the high-flow pump outlet line 52b) and the organic filter (not shown), and is configured to move blood from the access line and the buffer reservoir line to the organic filter. The processing kit includes an organic filter outlet line 52d operatively coupled to the organic filter and the buffer reservoir and configured to move blood from the organic filter to the buffer reservoir. The processing kit includes a return line 52e operatively coupled to the buffer reservoir (via buffer reservoir line 52g) and the patient and configured to move blood from the buffer reservoir to the patient. Figure 3 Other components shown and discussed. For example, cassette 60 can interface with pumps P1-P3. Processing kit 25 can have dimensions optimized for the particular blood treatment being performed.

[0098] Figure 5 An illustrative method for extracorporeal blood treatment using an illustrative device and / or system is depicted in the accompanying drawings. Method 100 includes monitoring at least one of access pressure, organic filter pressure, return pressure, and buffer reservoir weight 102. Access pressure can be monitored using access pressure sensor 36a. Organic filter pressure can be monitored using organic filter pressure sensor 36b. Return pressure can be monitored using return pressure sensor 36c. Buffer reservoir weight can be monitored using a reservoir scale 130. Method 100 can also include adjusting the pump speed of at least one of the first low-flow pump P1, the second low-flow pump P2, and the high-flow pump P3 based on the monitored data 104. Adjusting the pump speed can be performed using the computing device 12 described herein.

[0099] The entire contents of all patents, patent documents, and references cited herein are incorporated by reference as if each were individually incorporated. This disclosure is provided with reference to illustrative embodiments, but this disclosure is not intended to be construed in a limiting sense. As previously mentioned, those skilled in the art will recognize that various other illustrative applications can use the techniques described herein to take advantage of the beneficial features of the systems and methods described herein. Various modifications of the illustrative embodiments and additional embodiments of the disclosure will be apparent by reference to this specification.

Claims

1. An apparatus for extracorporeal blood treatment using an organic filter operable to perform the function of a human organ, the apparatus comprising: a treatment kit comprising: tubing operatively coupled to a patient, wherein the treatment kit is configured to move blood from the patient to the organic filter and return filtered blood from the organic filter to the patient, and a high flow pump operatively coupled to the processing kit to move blood through the processing kit toward the organic filter; a first low flow pump operatively coupled to the processing kit to move blood from the patient through the processing kit toward the organic filter; a second low flow pump operatively coupled to the processing kit to move blood from the organic filter through the processing kit toward the patient; and A computing device is operatively coupled to the pump and configured to perform extracorporeal blood treatment by controlling the pump.

2. The apparatus of claim 1 , further comprising a buffer reservoir coupled to the process kit, wherein The computing device is further configured to: filling the buffer reservoir to hold a buffer volume of blood before performing the extracorporeal blood treatment; and controlling the high flow pump to move blood from the buffer reservoir to the organic filter at a high flow rate, and The first low flow pump is controlled to move blood from the patient to the organic filter at a first low flow rate.

3. The device according to claim 2, wherein The computing device is further configured to control the high flow rate and the first low flow rate as a combined flow rate, and wherein the combined flow rate is configured to move a sufficient amount of blood to the organic filter at a sufficient flow rate to facilitate function of the organic filter.

4. The device according to any one of claims 1 to 3, wherein The computing device is further configured to control the second low flow pump to return blood from the organic filter to the patient at a second low flow rate.

5. The device according to claim 1, wherein The first low flow pump is configured to move blood from the patient to the organic filter at a first low flow rate, and the second low flow pump is configured to return blood from the organic filter to the patient at a second low flow rate, wherein the first low flow rate is equal to the second low flow rate.

6. The device according to any one of claims 2 to 5, wherein The processing kit includes: an access line operatively coupled to the patient and configured to receive blood from the patient; a buffer reservoir line operatively coupled to the buffer reservoir and configured to receive blood from the buffer reservoir; an organic filter inlet line operatively coupled to the access line, the buffer reservoir line, and the organic filter and configured to move blood from the access line and the buffer reservoir line to the organic filter; an organic filter outlet line operatively coupled to the organic filter and the buffer reservoir and configured to move blood from the organic filter to the buffer reservoir; and A return line is operatively coupled to the buffer reservoir and the patient and is configured to move blood from the buffer reservoir to the patient.

7. The device according to any one of claims 2 to 6, wherein: The processing kit further comprises: A leak line is operatively coupled to the buffer reservoir and configured to move fluid that leaks from the organic filter to the buffer reservoir.

8. The device according to any one of claims 1 to 7, wherein The processing kit further comprises: an access pressure sensor configured to sense an access pressure of blood within the treatment kit downstream of a patient access site; an organic filter pressure sensor configured to sense an organic filter pressure of blood within the processing kit upstream of the organic filter; and A return pressure sensor is configured to sense a return pressure of blood within the treatment kit proximate a patient return site.

9. The device according to claim 8, wherein The computing device is operatively coupled to a pressure sensor and is further configured to control at least one of the high flow pump, the first low flow pump, and the second low flow pump to maintain the access pressure within an access pressure limit, maintain the organic pressure within an organic filter pressure limit, and maintain the return pressure within a return pressure limit.

10. The device according to claim 9, wherein The access pressure limit is greater than or equal to -250 mmHg and less than or equal to 150 mmHg.

11. The device according to any one of claims 9 to 10, wherein The return pressure limit is greater than or equal to 50 mmHg and less than or equal to 300 mmHg.

12. The device according to any one of claims 2 to 11, wherein The extracorporeal blood treatment apparatus further comprises a scale configured to weigh the buffer reservoir, and wherein the computing device is further configured to control at least one of the high-flow pump, the first low-flow pump, and the second low-flow pump to maintain a buffer weight of the buffer reservoir.

13. The device according to any one of claims 1 to 12, wherein The process kit also includes a degassing chamber, an air detector, and a return line fixture. wherein the degassing chamber is positioned downstream of the return pressure sensor, and wherein the air detector is positioned downstream of the degassing chamber, and wherein the return line clamp is positioned downstream of the air detector, and Wherein, the computing device is configured to stop the first low-flow pump and the second low-flow pump and close the return pipe clamp when the air detector detects air.

14. The device according to any one of claims 1 to 13, wherein The treatment kit further includes an oxygenator configured to oxygenate the blood, The oxygenator is positioned downstream of the high-flow pump and the first low-flow pump and upstream of the organic filter.

15. The device according to any one of claims 2 to 14, wherein The processing kit further includes a first sample port, a second sample port, a third sample port, and a fourth sample port, wherein each sample port is configured to remove a blood sample, wherein the first sample port is positioned downstream of the access pressure sensor, and wherein the second sample port is positioned upstream of the organic filter pressure sensor, and wherein the third sample port is positioned downstream of the organic filter and upstream of the buffer reservoir, and wherein the fourth sample port is positioned upstream of the return pressure sensor.

16. The device according to any one of claims 1 to 15, wherein The organic filter is operable to perform a function of at least one of a human liver organ, a human kidney organ, and a human lung organ.

17. A processing kit comprising: an access line operatively coupled to a patient and configured to receive blood from the patient; a buffer reservoir line operatively coupled to the buffer reservoir and configured to receive blood from the buffer reservoir; an organic filter inlet line operatively coupled to the access line, the buffer reservoir line, and the organic filter and configured to move blood from the access line and the buffer reservoir line to the organic filter; an organic filter outlet line operatively coupled to the organic filter and the buffer reservoir and configured to move blood from the organic filter to the buffer reservoir; as well as A return line is operatively coupled to the buffer reservoir and the patient and is configured to move blood from the buffer reservoir to the patient.

18. The process kit of claim 17, wherein: The access line is configured to move blood from the patient through the processing kit toward the organic filter at a first low flow rate, and wherein the return line is configured to move blood from the organic filter through the processing kit toward the patient at a second low flow rate, and wherein the buffer reservoir line is configured to move blood from the buffer reservoir through the processing kit toward the organic filter at a high flow rate, and The flow rate is controlled to ensure sufficient blood flow through the treatment kit to perform extracorporeal blood treatment on the patient.

19. The process kit according to any one of claims 17 to 18, wherein: The access line and the buffer reservoir line merge into the organic filter inlet line, and wherein the blood flow through the access line and the blood flow through the buffer reservoir line merge into a combined organic filter inlet blood flow, and wherein the first low flow rate and the high flow rate merge into a combined flow rate, and The combined flow is configured to move a sufficient amount of blood to the organic filter at a sufficient flow rate to facilitate the function of the organic filter.

20. The process kit of claim 18, wherein: The first low flow rate is equal to the second low flow rate.

21. The process kit according to any one of claims 17 to 20, further comprising: A leak line is operatively coupled to the buffer reservoir and configured to move fluid that leaks from the organic filter to the buffer reservoir.

22. The process kit according to any one of claims 17 to 21, further comprising: an access pressure sensor configured to sense an access pressure of blood within the treatment kit downstream of a patient access site; an organic filter pressure sensor configured to sense an organic filter pressure of blood within the processing kit upstream of the organic filter; as well as A return pressure sensor is configured to sense a return pressure of blood within the treatment kit proximate a patient return site.

23. The process kit of claim 22, wherein: At least one of the high flow rate, the first low flow rate, and the second low flow rate is configured to maintain the access pressure within an access pressure limit, maintain an organic pressure within an organic filter pressure limit, and maintain a return pressure within a return pressure limit.

24. The process kit according to any one of claims 18 to 23, wherein: At least one of the high flow rate, the first low flow rate, and the second low flow rate is configured to maintain a buffer weight of the buffer reservoir.

25. The process kit of any one of claims 17 to 24, further comprising a degassing chamber, an air detector, and a return line fixture, and in, The degassing chamber is positioned downstream of the return pressure sensor, and wherein the air detector is positioned downstream of the degassing chamber, and wherein the return line clamp is positioned downstream of the air detector, and Wherein, when the air detector detects air, the first low flow and the second low flow are configured to stop, and the return pipe clamp is configured to close.

26. The treatment kit according to any one of claims 17 to 25, further comprising an oxygenator configured to oxygenate blood, in, The oxygenator is positioned upstream of the organic filter.

27. The process kit of any one of claims 17 to 26, further comprising a first sample port, a second sample port, a third sample port, and a fourth sample port, wherein Each sample port is configured to pipette a blood sample, wherein the first sample port is positioned downstream of the access pressure sensor, and wherein the second sample port is positioned upstream of the organic filter pressure sensor, and wherein the third sample port is positioned downstream of the organic filter and upstream of the buffer reservoir, and wherein the fourth sample port is positioned upstream of the return pressure sensor.

28. A method comprising: monitoring at least one of an inlet pressure, an organic filter pressure, a return pressure, and a buffer reservoir weight of the extracorporeal blood treatment apparatus, wherein the monitoring of the access pressure is performed using an access pressure sensor, and wherein the monitoring of the organic filter pressure is performed using an organic filter pressure sensor, and wherein the monitoring of the return pressure is performed using a return pressure sensor, and wherein the monitoring of the buffer reservoir weight is performed using a reservoir scale; and A pump speed of at least one of a first low flow pump, a second low flow pump, and a high flow pump is adjusted based on at least one of the monitored access pressure, the organic filter pressure, the return pressure, and the buffer reservoir weight.

29. A computer-readable medium configured to: monitoring at least one of an access pressure, an organic filter pressure, a return pressure, and a buffer reservoir weight, in, The monitoring of the access pressure is performed using an access pressure sensor, and wherein the monitoring of the organic filter pressure is performed using an organic filter pressure sensor, and wherein the monitoring of the return pressure is performed using a return pressure sensor, and wherein the monitoring of the buffer reservoir weight is performed using a reservoir scale; and A pump speed of at least one of a first low flow pump, a second low flow pump, and a high flow pump is adjusted based on at least one of the monitored access pressure, the organic filter pressure, the return pressure, and the buffer reservoir weight.

30. An apparatus for extracorporeal blood treatment using an organic filter operable to perform the function of a human organ, the apparatus comprising: A computing device is operatively coupled to the at least one pump and configured to perform extracorporeal blood treatment by controlling the at least one pump.

31. An extracorporeal blood treatment apparatus, comprising: A treatment kit comprising tubing operatively coupled to a patient, wherein the treatment kit is configured to move blood from the patient to an organic filter and return filtered blood to the patient, the organic filter being operable to perform a function of a human organ, the treatment kit comprising: an access line operatively coupled to a patient and configured to receive blood from the patient; an organic filter inlet line operatively coupled to the access line and the organic filter, the organic filter inlet line configured to move blood from the access line to the organic filter; a return line operatively coupled to the patient and configured to move blood back to the patient; a high flow pump outlet line operatively coupled to at least one of the access line and the organic filter inlet line and configured to move blood from the organic filter to at least one of the access line and the organic filter inlet line; a first low-flow pump operatively coupled to the access line and configured to move blood from the patient through the processing kit toward the organic filter; a second low-flow pump operatively coupled to the return line and configured to move blood from the organic filter through the processing kit toward the patient; a high flow pump operatively coupled to the high flow pump outlet line and configured to move blood from the organic filter to at least one of the access line and the organic filter inlet line and further move blood to the organic filter; a computing device operatively coupled to the pumps and configured to control the first low-flow pump to move blood from the patient through the treatment kit toward the organic filter, control the second low-flow pump to move blood from the organic filter through the treatment kit toward the patient, and control the high-flow pump to move blood from the organic filter to the access line or the organic filter inlet line and further to the organic filter.

32. The extracorporeal blood treatment apparatus according to claim 31 , further comprising: Buffer storage; as well as an organic filter outlet line operatively coupled to the organic filter and the buffer reservoir and configured to move blood from the organic filter to the buffer reservoir; a buffer reservoir line operatively coupled to the buffer reservoir and the high flow pump outlet line and configured to move blood from the buffer reservoir to the high flow pump, Wherein, the computing device is configured to control the high flow pump to move blood from the buffer reservoir to at least one of the access line and the organic filter inlet line, and further to move blood to the organic filter.

33. The extracorporeal blood treatment apparatus according to any one of claims 31 and 32, wherein The high flow pump outlet line is operatively coupled to the access line downstream of the first low flow pump.

34. The extracorporeal blood treatment apparatus according to any one of claims 31 to 33, further comprising an oxygenator placed in the organic filter inlet line downstream of the connection of the high flow pump outlet line to the access line.

35. The extracorporeal blood treatment apparatus according to any one of claims 32 to 34, further comprising a leakage line operatively coupled to the container accommodating the organic filter and the buffer reservoir, and configured to discharge fluid leaking from the organic filter to the buffer reservoir.

36. The extracorporeal blood treatment apparatus according to any one of claims 32 to 35, wherein The return line is operatively coupled to the buffer reservoir line upstream of the high flow pump.

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