Single or double lumen systems

Abstract

The present disclosure provides methods and systems for improving extracorporeal blood processing and therapy.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Patent Application No. 63 / 423,144, filed November 7, 2022, the entire contents of which are incorporated herein by reference for all purposes. [Background technology]

[0002] In extracorporeal blood processing, blood is withdrawn from a patient (e.g., a human or animal) for a treatment process, and the treated blood is then returned to the patient. Conventional extracorporeal blood processing methods include, but are not limited to, apheresis, plasma exchange, hemoperfusion (HPF), and renal replacement therapy (RRT) such as ultrafiltration (UF), hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF). Blood-based RRT systems generally require access to the patient's vascular flow. In conventional RRT systems, sufficient clearance of waste molecules and / or fluids from the treated blood requires a constant blood flow rate through the treatment module.

[0003] Embodiments of the presently disclosed subject matter improve extracorporeal blood processing and treatment and provide other advantages as well. Summary of the Invention

[0004] In one embodiment, the present disclosure provides a method of blood processing, the method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a blood chamber through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate from the blood chamber through the extracorporeal treatment device to subject the blood to extracorporeal treatment, and returning the treated blood to the blood chamber; (c) returning the blood from the blood chamber through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; The method provides that the second flow rate is separate from both the first flow rate and the third flow rate.

[0005] In another embodiment, the present disclosure provides a method of blood processing, the method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a first T-junction through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate through the first T-junction to the extracorporeal treatment device for extracorporeal treatment of the blood, and returning the treated blood to the second T-junction; and (c) returning the blood from the second T-junction through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; or alternatively, (d) conveying the blood from the second T-junction to a blood chamber for extracorporeal reprocessing of the blood, wherein the second flow rate is separated from both the first flow rate and the third flow rate.

[0006] In yet another embodiment, the present disclosure provides a method of blood processing, the method comprising: (a) conveying a volume of blood through a conduit from a patient's vascular access to a T-junction at a first flow rate, the conduit having a lumen; (b) conveying the blood at a second flow rate through the T-junction to the extracorporeal treatment device to subject the blood to extracorporeal treatment, and returning the treated blood to the blood chamber; (c) returning the blood from the blood chamber to the patient's vascular access at a third flow rate, wherein the second flow rate is separate from both the first flow rate and the third flow rate.

[0007] Additional objects, advantages and embodiments of the presently disclosed subject matter will become apparent from the following description when considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a simplified schematic diagram of a generalized blood processing system according to one or more embodiments of the presently disclosed subject matter. [Figure 2A] FIG. 2A is a simplified schematic diagram of a generalized blood processing system according to one or more embodiments of the presently disclosed subject matter. [Figure 2B] FIG. 2B is a simplified schematic diagram of a generalized blood processing system according to one or more embodiments of the presently disclosed subject matter. [Figure 3] FIG. 3 is a simplified schematic diagram of a generalized blood processing system according to one or more embodiments of the presently disclosed subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0009] FIG. 1 illustrates an embodiment of the present disclosure. The system 100 includes a double-lumen configuration using a four-port blood chamber, reservoir, or bag 130. The system 100 transports blood to and from a patient 115 and processes the blood for therapy. For example, a vascular access 116 is coupled to a single-lumen conduit 118 and uses a first blood pump 121 to pump blood from the patient or subject 115 to the blood chamber 130. The blood pump may be, for example, a centrifugal pump, a Harvard device, or a syringe pump. The vascular access 116 may include a needle, catheter, or any other device known in the art for connecting to a patient's vascular system. The extracorporeal treatment device or treatment module (used interchangeably) 140 is designed or configured to affect extracorporeal treatment of blood passing therethrough, such as filtration, hemoperfusion, plasma separation, dialysis treatments including, but not limited to, ultrafiltration, hemofiltration (HF), hemodiafiltration (HDF), hemodialysis (HD), or hemoperfusion (HPF).

[0010] In certain embodiments, blood from patient 115 fills blood chamber 130 using conduit 118 and first blood pump 121. This unprocessed blood exits blood chamber 130 via conduit 133 using second blood pump 131. Processing module 140 processes the blood and returns it to the blood chamber using conduit 143. Fluid / drug module 135 with associated supply conduit 136 may be used to infuse, for example, an anticoagulant into conduit 133. For example, when the patient is not otherwise receiving an anticoagulant, controller 125 can direct the addition of an appropriate anticoagulant, such as, but not limited to, heparin, a citrate-based anticoagulant, nafamostat, or epoprostenol, via conduit 136 from fluid / drug module 135.

[0011] In a particular example, controller 125 controls fluid / drug module 135, first blood pump 121, second blood pump 131, third blood pump 155, blood chamber 130, processing module 140, and fluid / drug module 135, and various valves or other fluid control components (not shown) to pump secondary fluid and / or anticoagulant from fluid / drug module 135 via input conduit 136 to conduit 133 and into the patient's blood.

[0012] During operation, blood is drawn from the patient 115 via the access 116 and delivered to the chamber 130 for temporary storage pending treatment. For example, the controller 125 can control the first blood pump 125 and various valves or other fluid control components (not shown) to pump blood from the patient 115 along the single-lumen conduit 118 to the blood chamber 130 at a first flow rate. Blood delivery continues until a predetermined blood volume is achieved in the chamber 130. The predetermined blood volume can be adjustable based on the size of the patient 115 and can be, for example, 2-7% or 1-15% of the patient's 115 total blood volume, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15%. For example, the predetermined blood volume can be 10-300 ml, or 10-1000 ml, and can be set by the patient 115 or a system operator. The treatment may be repeated until the entire blood volume (eg, about 5 liters) has been treated.

[0013] The controller 125 can monitor the volume of blood in the chamber 130 and determine whether a predetermined volume of blood has been filled. For example, the weight of the chamber 130 and its contents can be monitored by a highly accurate weight sensor, such as a gravity scale. Because the volume of blood in the chamber 130 is relatively small (e.g., less than 300 ml), the chamber 130 can be weighed very accurately, avoiding inaccurate volume correlations. For example, the weight sensor can have an accuracy of ±1 gram or better. Those skilled in the art will know of other sensors for measuring fluid levels that can be used, including, but not limited to, float, gauge, and capacitance level sensors, optical sensors, and other volumetric or weight sensors.

[0014] The controller 125 can then correlate the change in weight of the chamber 130 with the change in the volume of fluid / blood therein. The controller 125 can also correlate the presence or change in signal when other volume level sensors are used. In some aspects, the weight sensor provides a real-time signal to the controller 125 while the chamber 130 is filling. In this manner, the sensor and / or controller 125 can be configured to compensate for any weight fluctuations due to hydrodynamic action / vibrations within the chamber while the blood is flowing.

[0015] The present disclosure provides a method of blood processing, the method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a blood chamber through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate from the blood chamber through a treatment module to subject the blood to extracorporeal treatment, and returning the treated blood to the blood chamber; (c) returning the blood from the blood chamber through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; The method provides that the second flow rate is separate from both the first flow rate and the third flow rate.

[0016] The first flow rate is dependent on the flow rate of first blood pump 121, which fills blood chamber 130 by transporting blood from patient 115 through conduit 118. The second flow rate is determined by second blood pump 131, which removes blood from blood chamber 130 through conduit 133 and passes it to extracorporeal treatment device or treatment module 140. The second flow rate transports blood from treatment module 140 through conduit 143 and back to blood chamber 130. The third flow rate is determined by third blood pump 155, which removes blood from blood chamber 130 through conduit 152 and returns it to the patient through lumen 162.

[0017] In certain aspects, the second flow rate is faster than both the first and third flow rates combined. Such flow rates allow the blood to be treated before being returned to the blood chamber. Because the treatment process is separate from the blood withdrawal and infusion, lower blood flow rates may be used for blood withdrawal / infusion, thereby allowing for a smaller bore / diameter for the needle or lumen, allowing access to the patient's vascular system. While the present disclosure uses "blood" as an exemplary bodily fluid, those skilled in the art will recognize that the disclosed systems and methods are also useful for other bodily fluids, such as blood, lymph, ascites, abdominal fluid, pleural fluid, organ fluid, spinal fluid, intestinal fluid, or water. Similarly, while "vascular access" is an exemplary embodiment, those skilled in the art will recognize that ascites requires abdominal access, spinal fluid requires spinal canal access, and lymph requires lymphatic access. In some embodiments, the treated blood can be returned to the blood chamber and repeatedly treated by the treatment module (e.g., passed through the treatment module multiple times), e.g., to further improve solute clearance before being returned to the patient 115.

[0018] In some aspects, the systems and methods herein utilize a small lumen 116 (e.g., either a lumen smaller than 7 French, such as a 6, 5, 4, or 3 French lumen, or a lumen smaller than 17 gauge, such as a 16, 15, 14, 13, 12, 11, or 10 gauge lumen) to draw a "micro" batch of blood or bodily fluid (e.g., about 10-300 ml, or 2-7%, such as about 2, 3, 4, 5, 6, or 7%, of the total blood volume of the patient 115) into the chamber 130 at a first flow rate. The volume of bodily fluid can be, for example, about 10 ml-100 ml, 10 ml-200 ml, 10 ml-300 ml, 10 ml-400 ml, 10 ml-500 ml, 10 ml-600 ml, 10 ml-700 ml, 10 ml-800 ml, 10 ml-900 ml, or 10 ml-1000 ml. Once in chamber 130, the batch of blood can be circulated at a second, higher flow rate through a processing module 140 (processing circuit), such as a hemofilter, hemodialyzer, or hemoperfusion device, allowing for efficient clearance of small and medium molecules. After sufficient circulation, the blood is returned 152 and returned to the patient via lumen 162 at a third flow rate (which may be the same as or different from the first flow rate). This cycle (within the processing circuit) can then be repeated multiple times to process the patient's total blood volume, for example, approximately 5 liters.

[0019] 2A, disclosed herein is another embodiment of the present disclosure. The present disclosure is a method of blood processing, the method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a first T-junction through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate through the first T-junction to the extracorporeal treatment device for extracorporeal treatment of the blood, and returning the treated blood to the second T-junction; and (c) returning the blood from the second T-junction through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; or alternatively, (d) conveying the blood from the second T-junction to a blood chamber for extracorporeal reprocessing of the blood, wherein the second flow rate is separated from both the first flow rate and the third flow rate.

[0020] System 200 includes a double-lumen configuration using a two-port blood chamber, reservoir, or bag 230. System 200 transports blood to and from patient 215 and processes the blood for therapy. For example, vascular access 216 is coupled to a single-lumen conduit 218, which delivers blood from patient or subject 215 to a first T-junction 225 at a first flow rate. In certain embodiments, blood leaving patient 215 is transported to the first T-junction using conduit 218 and first blood pump 221. Vascular access 216 may include a needle, catheter, or any other device known in the art for connection to the patient's vasculature. Processing module 240 is designed to affect extracorporeal treatment of blood passing therethrough, for example, dialysis treatment, including, but not limited to, hemofiltration (HF), hemodiafiltration (HDF), hemodialysis (HD), or hemoperfusion (HPF).

[0021] In certain embodiments, blood or other bodily fluids are conveyed using conduit 233 at a second flow rate determined by second blood pump 231 to pass the blood from first T-junction 225 to extracorporeal treatment device or treatment module 240 for extracorporeal treatment, and the treated blood is returned to second T-junction 250. The blood or other bodily fluids are moved or conveyed from treatment module 240 to second T-junction 250 via conduit 243. Treatment module 240 treats the blood and returns it to the blood chamber using conduit 243. A fluid / drug module 235 with an associated supply conduit 236 can be used to infuse anticoagulant into conduit 233, for example. For example, if the patient is not otherwise receiving an anticoagulant, controller 225 can direct the addition of an appropriate anticoagulant, such as, but not limited to, heparin, a citrate-based anticoagulant, nafamostat, or epoprostenol, from fluid / drug module 235 via conduit 236. Processing module 240 processes the blood and delivers it to blood chamber 230 using conduit 243.

[0022] In certain embodiments, the method provides for returning blood from second T-junction 250 to a second vascular access of patient 262 via second conduit 252, the second conduit having second lumen 262. The third flow rate is determined by third blood pump 255.

[0023] Alternatively or additionally, the method provides for conveying blood from second T-junction 250 to blood chamber 230 for reprocessing or repetition within extracorporeal blood processing module 240. In certain embodiments, the second flow rate is separate from both the first flow rate and the third flow rate.

[0024] Once in chamber 230, the batch of blood may be circulated through processing module 240 (processing circuit) at a second, higher flow rate. After sufficient circulation, the blood is returned 252 and returned to the patient via lumen 262 at a third flow rate (which may be the same as the first flow rate or may be different from the first flow rate). This cycle may then be repeated multiple times, for example, to process the patient's total blood volume.

[0025] 2B shows system 200 with flow rates associated with first, second, and third flow rates. For example, the processing circuit includes first T-junction 255, second blood pump 231, conduit 233, processing module 240, conduit 243, second T-junction 250, conduit 256, and blood chamber 230. The processing circuit including the second flow rate is isolated from both the first and third flow rates.

[0026] The second flow rate is illustrated by the arrow surrounding 235 and is between about 300 ml / min and about 600 ml / min, including about 300 ml / min, 325 ml / min, 350 ml / min, 375 ml / min, 400 ml / min, 425 ml / min, 450 ml / min, 475 ml / min, 500 ml / min, 525 ml / min, 550 ml / min, 575 ml / min, and 600 ml / min.

[0027] The first flow rate and the third flow rate 259 are between about 50 ml / min and about 500 ml / min, for example, about 50 ml / min, 75 ml / min, 100 ml / min, 125 ml / min, 150 ml / min, 175 ml / min, and about 200 ml / min. The first flow rate and the third flow rate may be the same or different.

[0028] 3 illustrates yet another embodiment of the present disclosure. System 300 includes a single lumen configuration using a two-port blood chamber, reservoir 330 or bag. The present disclosure provides a method of blood processing, the method comprising: (a) conveying a volume of blood through a conduit from a patient's vascular access to a T-junction at a first flow rate, the conduit having a lumen; (b) conveying the blood at a second flow rate through the T-junction to the extracorporeal treatment device to subject the blood to extracorporeal treatment, and returning the treated blood to the blood chamber; (c) returning the blood from the blood chamber to the patient's vascular access at a third flow rate, wherein the second flow rate is separate from both the first flow rate and the third flow rate.

[0029] System 300 transports blood to / from patient 315 and processes the blood for therapy. For example, vascular access 316 is coupled to single-lumen conduit 318, which delivers blood from patient or subject 315 to T-junction 325 at a first flow rate, the conduit having a lumen. First blood pump 321 transports blood in conduit 318 from patient 315 to T-junction 325. The blood is transported at a second flow rate from T-junction 325 to processing module 340, which performs extracorporeal processing on the blood and returns the treated blood to blood chamber 330.

[0030] In certain embodiments, the method provides for returning blood through conduit 318 from T-junction 325 to the vascular access of patient 316 at a third flow rate. The third flow rate is determined by first blood pump 321. In certain embodiments, the second flow rate is separate from both the first flow rate and the third flow rate. In certain instances, the second flow rate is faster than both the first flow rate and the third flow rate combined.

[0031] In one embodiment, the present disclosure provides a system for blood processing, the system comprising: a blood chamber for holding a batch of blood from a patient; a first conduit for conveying blood from a patient's vascular access to a blood chamber at a first flow rate, the first conduit having a first lumen; a filter for performing extracorporeal treatment of blood passing therethrough by removing waste molecules, pathogens, and / or fluids; a recirculating blood processing loop connecting the blood chamber to the filter; a first blood pump for transporting blood from the patient to the blood chamber; a second blood pump for pumping blood at a second flow rate through the recirculating blood processing loop; a third blood pump for conveying blood from the blood chamber through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; a controller configured to control a first blood pump for transporting blood from the patient to the blood chamber, a second blood pump for transporting blood through a recirculating blood processing loop, and a third blood pump for transporting blood from the blood chamber to a second vascular access of the patient; A system comprising:

[0032] In another embodiment, the present disclosure provides a system for blood processing, the system comprising: a blood chamber for holding a batch of blood from a patient; a first conduit for conveying blood from a first vascular access of a patient to a first T-junction at a first flow rate, the first conduit having a first lumen; a first blood pump for transporting blood from the patient to the first T-junction; a recirculating blood processing loop connecting a blood chamber and a first T-junction to a filter and connecting the filter to a second T-junction, the second T-junction connecting to the blood chamber; a second blood pump for pumping blood at a second flow rate through the recirculating blood processing loop; a third blood pump for conveying blood from the second T-junction through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; a controller configured to control a first blood pump for transporting blood from the patient to a first T-junction, a second blood pump for transporting blood through a recirculating blood processing loop, and a third blood pump for transporting blood from the second T-junction to a second vascular access of the patient; A system comprising:

[0033] In yet another embodiment, the present disclosure provides a system for blood processing, the system comprising: a blood chamber for holding a batch of blood from a patient; a conduit for conveying blood from a patient's vascular access to a T-junction at a first flow rate, the conduit having a lumen; a first blood pump for transporting blood from the patient to the T-junction; a recirculating blood processing loop connecting the blood chamber to the filter and connecting the filter to the blood chamber; a second blood pump for pumping blood at a second flow rate through the recirculating blood processing loop; a first blood pump for conveying blood from the blood reservoir through a conduit to the patient's vascular access at a third flow rate; a controller configured to control a first blood pump for transporting blood from the patient to the T-junction, a second blood pump for transporting blood through the recirculating blood processing loop, and the first blood pump for transporting blood from the blood chamber to the patient's vascular access; A system comprising:

[0034] In certain embodiments, the controller is configured to control operation of the first, second and / or third blood pumps during extracorporeal treatment of a batch of blood from a patient.

[0035] In certain aspects, the controller is configured to control the blood pump to repeatedly recirculate the blood from the blood chamber through a filter or treatment module.

[0036] In certain aspects, the systems herein include one or more valves operatively coupled to a controller, for example, the controller configured to control one or more valves of the fluid circuit and the blood pump to deliver at least one of replacement fluid, anticoagulant, or anticoagulant drug from a respective source to the fluid path.

[0037] In some embodiments, the disclosed methods and systems can be used to treat other bodily fluids. For example, the accumulation of fluid within the abdominal cavity is called ascites. Ascites can be common in patients with cirrhosis, liver disease, or congestive heart failure. When removing bodily fluids such as ascites, a diuretic may also be administered. Commonly used diuretics include spironolactone (Aldactone) and / or furosemide (Lasix). When fluid retention cannot be optimally treated with diuretics and a low-salt diet, patients must undergo large-volume fluid removal (paracentesis) for symptomatic relief. The present disclosure includes methods and systems for treating ascites by withdrawal of ascites. Optionally, this withdrawn ascites can be concentrated and reinfused.

[0038] Embodiments of the presently disclosed subject matter provide extracorporeal blood treatment systems and methods that separate blood flow during the treatment process from blood flow to / from the patient. As a result, higher blood flow rates during the treatment process can result in improved solute clearance, including improved clearance of middle molecules over conventional systems. Because the treatment process is separated from blood withdrawal and infusion, lower blood flow rates may be used for blood withdrawal / infusion, thereby allowing for smaller bore / diameter needles or lumens that provide access to the patient's vascular system. While the present disclosure uses "blood" as an exemplary bodily fluid, those skilled in the art will recognize that the presently disclosed systems and methods are also useful for other bodily fluids, such as blood, lymph, ascites, intraperitoneal fluid, pleural fluid, organ fluid, spinal fluid, intestinal fluid, or water. Similarly, while "vascular access" is an exemplary embodiment, those skilled in the art will recognize that ascites requires abdominal access, spinal fluid requires spinal canal access, and lymph requires lymphatic access.

[0039] In certain embodiments, separation can be achieved by batch processing of blood. For example, a volume of blood is removed from a patient into a batch container. The blood in the batch container is then processed by a processing module and returned to the patient. Alternatively, a volume of blood is removed from the patient and sent to the processing module. In certain instances, the processed blood can be returned to the blood chamber and repeatedly processed by the processing module (e.g., passed multiple times through the processing module), thereby further improving solute clearance.

[0040] In some embodiments, the systems and methods utilize a small single lumen (e.g., a single lumen smaller than 7 French, such as a 6, 5, 4, or 3 French, or a single lumen smaller than 17 gauge, such as a 16, 15, 14, 13, 12, 11, or 10 gauge) to draw a "micro" batch (e.g., about 10-300 ml, or 2-7%, such as about 2, 3, 4, 5, 6, or 7%, of the patient's total blood volume) of blood or bodily fluid into a single reservoir at a first flow rate. The volume of bodily fluid can be, for example, about 10 ml-100 ml, 10 ml-200 ml, 10 ml-300 ml, 10 ml-400 ml, 10 ml-500 ml, 10 ml-600 ml, 10 ml-700 ml, 10 ml-800 ml, 10 ml-900 ml, or 10 ml-1000 ml. The batch of blood in the treatment circuit can be circulated at a second, higher flow rate through a treatment module, such as a hemofilter, hemodialyzer, or hemoperfusion device, allowing for efficient clearance of small and middle molecules. After sufficient circulation, the blood is returned to the patient through a small, single lumen at a third flow rate (which may be the same as or different from the first flow rate). This cycle can then be repeated multiple times, for example, to treat the patient's total blood volume.

[0041] In certain instances, the filter or filtration device may be an extracorporeal hemoadsorption filter device, e.g., for removing cytokines from circulating blood, and may be a biocompatible hemoadsorption bead technology such as CytoSorb™ from CytoSorbents™ Inc. CytoSorb hemoadsorption beads are porous polystyrene-divinylbenzene particles (average particle size 450 μm, pore size 0.8-5 nm, surface area 850 m) coated with a biocompatible polyvinyl-pyrrolidone derivative. 2 / g). See, for example, U.S. Patent No. 8,647,666, which claims a method of using a composition comprising a polystyrene-divinylbenzene copolymer and a polyvinylpyrrolidone polymer.

[0042] In another specific example, the filter or filtration device is a Seraph® Microbind® Affinity Blood Filter, which allows bodily fluids to pass through microbeads coated with molecular receptor sites that mimic the receptors on human cells that pathogens use to colonize when they invade the body. The adsorption medium is a flexible platform that uses covalently bound, immobilized heparin or heparan sulfate for its unique binding capabilities. See, for example, U.S. Pat. No. 8,758,286 or U.S. Pat. No. 9,173,989, which disclose at least one polysaccharide adsorbent or immobilized heparin.

[0043] Features discussed herein can be performed on a single or distributed processor (single-core and / or multi-core), by components distributed across multiple computers or systems, or by components co-located on a single processor or system. For example, aspects of the disclosed subject matter can be implemented via a programmed general-purpose computer, an integrated circuit device (e.g., an ASIC), a digital signal processor (DSP), an electronic device (e.g., a microprocessor or microcontroller) programmed with microcode, hardwired electronic or logic circuitry, programmable logic circuitry (e.g., a programmable logic device (PLD), a programmable logic array (PLA), a field programmable gate array (FPGA), a programmable array logic (PAL)), software stored on a computer-readable medium or signal, an optical computing device, a networked system of electronic and / or optical devices, an application-specific computing device, a semiconductor chip, software modules or objects stored on a computer-readable medium or signal.

[0044] When implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. The steps of a method or algorithm disclosed herein may be embodied in a processor-executable software module, which may be stored on a computer-readable medium. The instructions may be compiled from source code instructions provided according to a programming language. The programmed instructions and their associated data arrangements may be stored on a computer-readable medium (e.g., a non-transitory computer-readable medium), such as a computer-readable medium or storage device, which may be any suitable memory device, such as, but not limited to, a read-only memory (ROM), a programmable read-only memory (PROM), an electrically erasable programmable read-only memory (EEPROM), a random access memory (RAM), a flash memory, a disk drive, etc.

[0045] As used herein, computer-readable media includes both computer storage media and communication media, including any medium that facilitates transfer of a computer program from one place to another. As such, storage media may be any available medium that can be accessed by a computer. By way of example, and not limitation, such computer-readable media may include RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of instructions or data structures and that can be accessed by a computer.

[0046] Also, any connection is properly termed a computer-readable medium. For example, if software is transmitted from a website, server, or other remote source using a transmission medium (e.g., coaxial cable, fiber optic circuit, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, or microwave), the transmission medium is included in the definition of computer-readable medium. Furthermore, the operations of a method or algorithm may be stored as one (or any combination thereof) or set of code and / or instructions on a machine-readable and / or computer-readable medium, which may be embodied in a computer program product.

[0047] Ranges set forth herein should be understood to include the endpoints and all values ​​between the endpoints. Unless expressly stated otherwise, whenever the words "substantially," "approximately," "essentially," "approximately," "near," or similar terms are used in conjunction with a particular value, a variation of up to and including 10% of that value is intended.

[0048] It is therefore apparent that there is provided, in accordance with the present disclosure, an extracorporeal blood processing system and method using batch processing. Many alternatives, modifications, and variations are possible with this disclosure. While specific examples have been shown and described in detail to illustrate application of the principles of the invention, it should be understood that the invention may be practiced otherwise without departing from such principles. For example, disclosed features may be combined, rearranged, omitted, and the like to produce additional embodiments, while certain disclosed features may, in some cases, be used to advantage without the corresponding use of other features. Accordingly, applicants intend to embrace all such alternatives, modifications, equivalents, and variations that are within the spirit and scope of the present invention.

Claims

1. 1. A method of blood processing, said method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a blood chamber through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate from the blood chamber to an extracorporeal treatment device to perform extracorporeal treatment on the blood, and returning the treated blood to the blood chamber; (c) returning the blood from the blood chamber to a second vascular access of the patient via a second conduit at a third flow rate, the second conduit having a second lumen; The method, wherein the second flow rate is separate from both the first flow rate and the third flow rate.

2. The method of claim 1 , wherein the second flow rate is faster than both the first flow rate and the third flow rate combined.

3. The method of claim 1 , wherein the first conduit is a needle or cannula that forms at least a portion of the vascular access.

4. 4. The method of claim 3, wherein the catheter or needle of the first conduit has a size of either 2-11 French or 10-23 gauge.

5. 10. The method of claim 1, wherein the extracorporeal treatment is at least one of hemodialysis, hemofiltration, hemodiafiltration, or hemoperfusion.

6. 10. The method of claim 1, wherein the amount of blood comprises 2-7% of the patient's total blood volume.

7. The method of claim 1 , wherein the second flow rate comprises between 300 ml / min and 600 ml / min.

8. The method according to claim 1, wherein in step (b), middle molecules contained in the blood are removed via the extracorporeal treatment device.

9. the first conduit is a single-lumen catheter or needle having a size smaller than either 7 French or 17 gauge; and 2. The method of claim 1, wherein the clearance of β2 microglobulin is at least 100 ml / min.

10. 10. The method of claim 1, further comprising monitoring the weight of the blood chamber or the volume level of the blood chamber and correlating the monitored weight to a stage of a dialysis process.

11. 10. The method of claim 1, wherein the method includes, prior to (b), adding a first amount of replacement fluid and / or a second amount of anticoagulant to the blood chamber.

12. 1. A method of blood processing, said method comprising: (a) conveying a volume of blood from a first vascular access of a patient to a first T-junction through a first conduit at a first flow rate, the first conduit having a first lumen; (b) conveying the blood at a second flow rate through the first T-junction to an extracorporeal treatment device for extracorporeal treatment of the blood, and returning the treated blood to a second T-junction; and (c) returning the blood from the second T-junction to a second vascular access of the patient via a second conduit at a third flow rate, the second conduit having a second lumen; or alternatively, (d) conveying the blood from the second T-junction to a blood chamber for reprocessing the blood in the extracorporeal process, wherein the second flow rate is separated from both the first flow rate and the third flow rate.

13. The method of claim 12, wherein the first flow rate and the third flow rate are about 50 to 200 ml / min.

14. The method of claim 12, wherein the second flow rate is about 300 to 600 ml / min.

15. 13. The method of claim 12, wherein the first conduit is a needle or cannula that forms at least a portion of the vascular access.

16. 13. The method of claim 12, wherein the catheter or needle of the first conduit has a size of either 2 to 11 French or 10 to 23 gauge.

17. 13. The method of claim 12, wherein the extracorporeal treatment is at least one of hemodialysis, hemofiltration, hemodiafiltration, or hemoperfusion.

18. 13. The method of claim 12, wherein the amount of blood comprises 2-7% of the patient's total blood volume.

19. The method of claim 12, wherein the second flow rate comprises between 300 ml / min and 600 ml / min.

20. The method according to claim 12, wherein in step (b), middle molecules contained in the blood are removed via the extracorporeal treatment device.

21. the first conduit is a single-lumen catheter or needle having a size smaller than either 7 French or 17 gauge; and 13. The method of claim 12, wherein the clearance of β2 microglobulin is at least 100 ml / min.

22. 13. The method of claim 12, further comprising monitoring the weight of the blood chamber or the volume level of the blood chamber and correlating the monitored weight to a stage of a dialysis process.

23. 13. The method of claim 12, wherein the method includes, prior to (b), adding a first amount of replacement fluid and / or a second amount of anticoagulant to the blood chamber.

24. 1. A method of blood processing, said method comprising: (a) conveying a volume of blood from a patient's vascular access to a T-junction through a first conduit at a first flow rate, the conduit having a lumen; (b) conveying the blood at a second flow rate through the T-junction to an extracorporeal treatment device for extracorporeal treatment of the blood, and returning the treated blood to a blood chamber; (c) returning the blood from the blood chamber to the patient's vascular access at a third flow rate, the second flow rate being separate from both the first flow rate and the third flow rate.

25. 25. The method of claim 24, wherein the second flow rate is faster than both the first flow rate and the third flow rate combined.

26. 1. A system for blood processing, said system comprising: a blood chamber for holding a batch of blood from a patient; a first conduit for conveying blood from the patient's vascular access to the blood chamber at a first flow rate, the first conduit having a first lumen; a filter for performing extracorporeal treatment of blood passing therethrough by removing waste molecules, pathogens, and / or fluids; a recirculating blood processing loop connecting the blood chamber to the filter; a first blood pump for transporting blood from the patient to the blood chamber; a second blood pump for pumping blood through the recirculating blood processing loop at a second flow rate; a third blood pump for conveying blood from the blood chamber through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; a controller configured to control the first blood pump for transporting blood from the patient to the blood chamber, the second blood pump for transporting blood through the recirculating blood processing loop, and the third blood pump for transporting blood from the blood chamber to a second vascular access of the patient; A system comprising:

27. 1. A system for blood processing, said system comprising: a blood chamber for holding a batch of blood from a patient; a first conduit for conveying blood from a first vascular access of a patient to a first T-junction at a first flow rate, the first conduit having a first lumen; a first blood pump for transporting blood from the patient to a first T-junction; a recirculating blood processing loop connecting the blood chamber and the first T-junction to a filter and connecting the filter to a second T-junction, the second T-junction connecting to the blood chamber; and a second blood pump for pumping blood through the recirculating blood processing loop at a second flow rate. a third blood pump for conveying blood from the second T-junction through a second conduit to a second vascular access of the patient at a third flow rate, the second conduit having a second lumen; a controller configured to control the first blood pump for transporting blood from the patient to the first T-junction, the second blood pump for transporting blood through the recirculating blood processing loop, and the third blood pump for transporting blood from the second T-junction to a second vascular access of the patient; A system comprising:

28. 1. A system for blood processing, said system comprising: a blood chamber for holding a batch of blood from a patient; a conduit for conveying blood from a patient's vascular access to a first T-junction at a first flow rate, the conduit having a lumen; a first blood pump for transporting blood from the patient to a T-junction; a recirculating blood processing loop connecting the blood chamber to a filter and connecting the filter to the blood chamber; a second blood pump for pumping blood through the recirculating blood processing loop at a second flow rate; the first blood pump for conveying blood through the conduit from the blood reservoir to the patient's vascular access at a third flow rate; a controller configured to control the first blood pump to transport blood from the patient to the T-junction, the second blood pump to transport blood through the recirculating blood processing loop, and the first blood pump to transport blood from the blood chamber to the vascular access of the patient; A system comprising:

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