Extracorporeal blood treatment systems and methods including inline switching

The extracorporeal blood treatment system addresses clotting issues by alternating modes of operation to clean blood treatment devices, effectively managing clot formation and reducing bleeding risks through sensor-controlled fluid circulation.

WO2025254757A1PCT designated stage Publication Date: 2025-12-11THE NEMOURS FOUND
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Patent Information

Application Number
PCT/US2025/027691
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-05
Filing Date
2025-05-05
Publication Date
2025-12-11

AI Technical Summary

Technical Problem

Existing extracorporeal blood treatment systems face issues with coagulation and clotting, leading to system failure and potential bleeding complications due to the use of anticoagulants, which are typically introduced to prevent clotting.

Method used

An extracorporeal blood treatment system with dual modes of operation, alternating between blood treatment and cleaning fluid circulation through different blood treatment devices, using sensors and valves to switch modes based on parameter changes, thereby reducing the need for anticoagulants and minimizing clot formation.

Benefits of technology

The system effectively breaks up clots within blood treatment devices, reduces the risk of clot-related system failures, and minimizes patient bleeding complications by alternating cleaning fluid circulation, maintaining system functionality without significant anticoagulant use.

✦ Generated by Eureka AI based on patent content.

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Abstract

An extracorporeal blood treatment system includes an inlet conduit and an outlet conduit, first and second blood treatment devices, a cleaning segment comprising a cleaning fluid, and first and second valves. In a first mode the first valve and the second valve permit blood flow from a patient, through the inlet conduit, the first blood treatment device, and the outlet conduit and back to the patient and permit cleaning fluid flow from the cleaning segment, through the second blood treatment device, and back to the cleaning segment. In a second mode the first valve and the second valve permit blood flow from the patient, through the inlet conduit, the second blood treatment device, and the outlet conduit and back to the patient and permit cleaning fluid flow from the cleaning segment, through the first blood treatment device, and back to the cleaning segment.
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Description

EXTRACORPOREAL BLOOD TREATMENT SYSTEMS AND METHODS INCLUDING INLINE SWITCHINGRELATED APPLICATION

[0001] This application is related to and claims priority from United States Provisional Application No. 63 / 656,254, filed June 5, 2024, the disclosure of which is incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure generally relates to systems and methods for extracorporeal blood treatment. More specifically, the present disclosure relates to systems and methods for simultaneously treating the blood of a patient and breaking up or reducing development of blood clots in blood treatment devices.BACKGROUND OF THE DISCLOSURE

[0003] Various types of systems and methods are used to remove blood from the body of patient, treat the blood, and return the blood to the patient. For example, extracorporeal membrane oxygenation (ECMO) systems and methods treat severe cardiorespiratory failure and add oxygen to a patient’s blood. An exemplary ECMO system 100 is illustrated in FIG. 1. The system 100 includes an inlet conduit 102 that receives blood from a patient P. A pump 104 drives the blood in the inlet conduit 102 to an oxygenator 106, and the oxygenator 106 is in fluid communication with an air reservoir 108 and an oxygen reservoir 110, via a blender 112 and a flow meter 114, and thereby oxygenates the blood. The oxygenator 106 delivers oxygenated blood to an outlet conduit 116, which returns the oxygenated blood to the patient P.

[0004] As another example, continuous renal replacement therapy (CRRT) systems and methods treat renal failure and use a filter to remove toxins from a patient’s blood.As yet another example, plasma exchange (PLEX) systems and methods replace a patient’s plasma with fresh donor plasma.

[0005] However, treating blood in these manners can lead to coagulation and clotting, for example within 12 to 24 hours of continuous operation and typically in the oxygenator, filter, or plasma reservoir, which can lead to system and treatment failure. Accordingly, anticoagulants are typically introduced to these systems and thereby patients. However, such substances can potentially lead to bleeding complications. Accordingly, improved systems and methods for extracorporeal blood treatment would be beneficial.SUMMARY OF THE INVENTION

[0006] In one aspect, the present disclosure provides an extracorporeal blood treatment system including an inlet conduit and an outlet conduit, a first blood treatment device and a second blood treatment device, a cleaning segment including a cleaning fluid, and a first valve and a second valve. The extracorporeal blood treatment system is operable in a first mode and a second mode. In the first mode the first valve and the second valve permit blood flow from a patient, through the inlet conduit, the first blood treatment device, and the outlet conduit and back to the patient and permit cleaning fluid flow from the cleaning segment, through the second blood treatment device, and back to the cleaning segment. In the second mode the first valve and the second valve permit blood flow from the patient, through the inlet conduit, the second blood treatment device, and the outlet conduit and back to the patient and permit cleaning fluid flow from the cleaning segment, through the first blood treatment device, and back to the cleaning segment.

[0007] In another aspect, the present disclosure provides an extracorporeal blood treatment system including a patient interface segment configured to receive blood from a patient and deliver blood to the patient. The system further includes a first blood treatment segment and a second blood treatment segment, a cleaning segment, and a first valve and a second valve. The first valve and the second valve are operable to first positions and second positions. In the first positions the patient interface segment is influid communication with the first blood treatment segment and the cleaning segment is in fluid communication with the second blood treatment segment. In the second positions the patient interface segment is in fluid communication with the second blood treatment segment and the cleaning segment is in fluid communication with the first blood treatment segment.

[0008] In yet another aspect, the present disclosure provides a method for treating a patient using an extracorporeal blood treatment system. The method includes operating the extracorporeal blood treatment system in a first mode, which includes: receiving blood from the patient; treating the blood using a first blood treatment device; returning the blood to the patient; circulating a cleaning fluid through a cleaning segment and a second blood treatment device. The method further includes operating the extracorporeal blood treatment system in a second mode, which includes: receiving blood from the patient; treating the blood using the second blood treatment device; returning the blood to the patient; and circulating the cleaning fluid through the cleaning segment and the first blood treatment device.

[0009] In any of the embodiments, the first blood treatment device may be at least one of an oxygenator, a filter, a waste plasma reservoir, and a fresh plasma reservoir.

[0010] A sensor may be included in the embodiments that is operable to sense a change of a parameter of one of the blood and the cleaning fluid, and the extracorporeal blood treatment system, upon the sensor sensing the change of the parameter, may reconfigure from the first mode to the second mode. The sensor may be a pressure sensor and / or an optical sensor.

[0011] A pump may be included in any of the embodiments to cause blood flow through the inlet conduit and the outlet conduit. An additional or alternate pump may be included to cause cleaning fluid flow from the cleaning segment.

[0012] In any of the embodiments, the cleaning fluid may be an anticoagulant.

[0013] The extracorporeal blood treatment system of claim 11 , further comprising a sensor operable to sense a change of a parameter of one of the blood and the cleaning fluid, and wherein the system, upon the sensor sensing the change of the parameter, reconfigures at least one of the first valve and the second valve from the first positions to the second positions.

[0014] In an embodiment, a first sensor is operable to sense a change of a first parameter of the blood, and the system, upon the first sensor sensing the change of the first parameter, reconfigures the first valve from its first position to its second position. A second sensor is included and operable to sense a change of a second parameter of one of the blood and the cleaning fluid. Upon the sensor sensing the change of the second parameter, reconfigures the second valve from its first position to its second position.

[0015] The first sensor may be a first type of sensor and the second sensor may be a second type of sensor that is different from the first type of sensor. A controller may be operably coupled to the first valve and the second valve. The controller is preferably operable to reconfigure the extracorporeal blood treatment system from the first mode to the second mode and vice versa.

[0016] In any of the disclosed methods, the method may include transitioning the extracorporeal blood treatment system from the first mode to the second mode upon sensing a change of a parameter of one of the blood and the cleaning fluid. The methods may also include, after operating the extracorporeal blood treatment system in the second mode, again operating the extracorporeal blood treatment system in the first mode.

[0017] The foregoing and other features of the invention and advantages of the present invention will become more apparent in light of the following detailed description of the preferred embodiments, as illustrated in the accompanying figures. As will be realized, the invention is capable of modifications in various respects, all without departing from the invention. Accordingly, the drawings and the description are to be regarded as illustrative in nature, and not as restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] For illustrative purposes, the drawings show an embodiment which is presently preferred. However, it should be understood that the present disclosure is not limited to the embodiment illustrated in the drawings.

[0019] FIG. 1 is a schematic view of an extracorporeal membrane oxygenation (ECMO) system according to related art.

[0020] FIG. 2 is a schematic view of an extracorporeal blood treatment system providing a blood treatment to a patient and operating in a first mode, according to an embodiment of the present disclosure.

[0021] FIG. 3 is a schematic view of the extracorporeal blood treatment system of FIG. 2 providing the blood treatment to the patient and transitioning from the first mode to a second mode, according to an embodiment of the present disclosure.

[0022] FIG. 4 is a schematic view of the extracorporeal blood treatment system of FIG. 2 providing the blood treatment to the patient and operating in the second mode, according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE DRAWINGS

[0023] Referring to the drawings, wherein like reference numerals identify corresponding or similar elements throughout the several views, FIGS. 2-4 illustrate an extracorporeal blood treatment system 200, according to an embodiment of the present disclosure, and a patient P receiving a blood treatment from the system 200. The extracorporeal blood treatment system 200 operates in different modes to provide the blood treatment to the patient P while simultaneously cleaning or replacing certain components. Relatedly, FIG. 2 illustrates the extracorporeal blood treatment system 200 operating in a first mode, FIG. 3 illustrates the extracorporeal blood treatment system 200 transitioning from the first mode to a second mode, and FIG. 4 illustrates the extracorporeal blood treatment system 200 operating in the second mode. The operating modes of the extracorporeal blood treatment system 200 are described in further detail below.

[0024] In some embodiments, the extracorporeal blood treatment system 200 adds oxygen to the blood of the patient P and thereby treats severe cardiorespiratory failure. In some embodiments, the extracorporeal blood treatment system 200 removes toxins from the blood of the patient P and thereby treats renal failure. In some embodiments, the extracorporeal blood treatment system 200 replaces plasma of the patient P with fresh donor plasma. In other embodiments, the extracorporeal blood treatment system 200 treats the blood of the patient in a different manner, for example, adding medications.

[0025] The extracorporeal blood treatment system 200 generally includes a patient interface segment 202 that receives blood (illustrated with relatively sparse speckling) from the patient P and ultimately returns treated blood (illustrated with relatively dense speckling) to the patient P, a first blood treatment segment 204, a second blood treatment segment 206, and a cleaning segment 208. A first valve 210 and a second valve 212 couple these segments to each other, and the positions of the valves 210 and 212 control the operating mode of the system 200, more specifically the valves 210 and 212 control fluid communication between one of the blood treatment segments 204 and206 and the patient interface segment 202 and fluid communication between the other of the blood treatment segments 204 and 206 and the cleaning segment 208.

[0026] The first valve 210 and / or a second valve 212 may be, for example and as illustrated, 4-way 2-position valves. More specifically, the first valve 210 and / or the second valve 212 may be, for example, the valve described in the U.S. Provisional Application No. 63,656,268 filed 6 / 5 / 2024, entitled “Valves For Extracorporeal Blood Treatment Systems,” the disclosure of which is incorporated herein by reference in its entirety.

[0027] Referring specifically to FIG. 2, while operating in the first mode the patient interface segment 202 is in fluid communication with the first blood treatment segment 204. More specifically, an inlet conduit 214 of the patient interface segment 202 receives blood from the patient P. A first pump 216, for example a centrifugal pump or the like, drives the blood in the inlet conduit 214 to the first valve 210. The first valve 210 is in its first position and delivers the blood to a first intermediate conduit 218 of the first blood treatment segment 204. The first intermediate conduit 218 delivers the blood to a first blood treatment device 220, for example, an oxygenator (particularly in embodiments in which the system 200 adds oxygen to the blood of the patient P), a filter (particularly in embodiments in which the system 200 removes toxins from the blood of the patient P), or a waste plasma reservoir and a fresh plasma reservoir (particularly in embodiments in which the extracorporeal blood treatment system 200 replaces plasma of the patient P with fresh donor plasma). In some embodiments, the first blood treatment device 220 may be a different type of device or include multiple devices, including any combination of the foregoing. The first blood treatment device 220 delivers treated blood to a second intermediate conduit 222, and the second intermediate conduit 222 delivers the treated blood to the second valve 212. The second valve 212 is in its first position and delivers the treated blood to an outlet conduit 224 of the patient interface segment 202, which returns the treated blood to the patient P.

[0028] With continued reference to FIG. 2, while operating in the first mode the cleaning segment 208 is in fluid communication with the second blood treatmentsegment 206. More specifically, a reservoir 232 delivers a cleaning fluid (illustrated with cross-hatching) to a first cleaning segment conduit 234. In certain embodiments, the cleaning fluid is a simple sterile solution. Such a solution may include, for example, distilled water or a crystalloid solution including 0.9% sodium chloride, lactated Ringer’s solution, or PlasmaLyte® fluid (available from Baxter International, Inc.). In certain embodiments, the cleaning solution can contain anticoagulants or other medications such as heparin, bivalirudin, tissue plasminogen activator (tPA), or protease. A second pump 236, for example a peristaltic pump or the like, drives the cleaning fluid in the first cleaning segment conduit 234 to the first valve 210. It should be readily apparent that the pumps described herein may be located upstream (directing flow) or downstream (drawing flow) through the conduits. The first valve 210, being in its first position, delivers the cleaning fluid to a third intermediate conduit 238 of the second blood treatment segment 206. The third intermediate conduit 238 delivers the cleaning fluid to a second blood treatment device 240, for example, an oxygenator, a filter, or a waste plasma reservoir and a fresh plasma reservoir. In some embodiments, the second blood treatment device 240 may be a different type of device or include multiple devices, including any combination of the foregoing. The second blood treatment device 240 delivers the cleaning fluid to a fourth intermediate conduit 242, and the fourth intermediate conduit 242 delivers the cleaning fluid to the second valve 212. The second valve 212, being in its first position, delivers the cleaning fluid to a second cleaning segment conduit 244 of the cleaning segment 208, which returns the cleaning fluid to the reservoir 232. While circulating through the cleaning segment 208 and the second blood treatment segment 206, the cleaning fluid internally cleans the components of the second blood treatment segment 206. More specifically, the cleaning fluid breaks up blood clots in the second blood treatment segment 206, particularly the second blood treatment device 240, if the system 200 was previously operated in the second mode, as described below.

[0029] After operating in the first mode for a time period, the system 200 changes to the second mode to clean the first blood treatment segment 204. More specifically, the valves 210 and 212 permit fluid communication between the first blood treatment segment 204 and the cleaning segment 208 and fluid communication between thesecond blood treatment segment 206 and the patient interface segment 202. The system 200 may change from the first mode to the second mode in response to one or more of various inputs. For example, in some embodiments and as illustrated, the first blood treatment segment 204 includes one or more sensors (illustratively, three sensors 246, 248, and 250) that sense a change of a parameter of flow through the first blood treatment segment 204. The sensors are operably coupled to an electronic controller 251 (for example, a general-purpose computer, a mobile device, or the like), which is also operably coupled to the first and second valves 210, 212. The controller 251 is programmed to change the positions of the first and second valves 210, 212, and thereby the operating mode of the system 200, in response to the sensor(s) sensing the change of the parameter of flow through the first blood treatment segment 204 relative to a threshold. In some embodiments, the first sensor 246 and / or the second sensor 248 are pressure sensors and sense the pressure of the flow in the first blood treatment segment 204. More specifically, the first sensor 246 and the second sensor 248 are positioned upstream and downstream, respectively, of the first blood treatment device 220 and thereby sense pressures at those locations and provide signals to the controller 251 . The controller 251 is programmed to determine the pressure difference in the flow across the first blood treatment device 220 based on the signals from the sensors 246, 248. If the pressure difference exceeds a threshold (for example, the pressure sensed by the first sensor 246 being at least double the pressure sensed by the second sensor 248), it may indicate the presence or development of blood clots or blockage in the first blood treatment device 220, and in response thereto the controller 251 changes the operating mode of the system 200. In certain embodiments, the controller 251 may utilize programming or artificial intelligence to facilitate automatically changing operating modes in the presence of an increasing clot burden, thrombus embolization, air embolus, declining post-membrane partial pressure of oxygen, declining platelet levels, and / or declining fibrinogen levels, or after learning when one or more of these are likely to occur. In some embodiments, the controller 251 changes the operating mode of the system 200 after a certain time period (for example, after 12 to 24 hours of continuous operation). In certain embodiments, an operator (for example, a medical professional) changes the operating mode of the system 200 via the controller 251 or by manuallychanging the positions of the first and second valves 210, 212. The controller 251 may include programming that permits an operator to select the preferred timing of the switching between operating modes. In some embodiments, the system 200 lacks the controller 251 and any sensors in which case the change is manually affected, presumably after a period of time.

[0030] FIG. 3 illustrates the system 200 changing from the first operating mode to the second operating mode. During this transition, the controller 251 synchronizes switching of the positions of the first valve 210 and the second valve 212. More specifically, the first valve 210 reconfigures from its first position to its second position such that the first blood treatment segment 204 begins to fill with the cleaning fluid and the second blood treatment segment 206 begins to fill with blood. When the cleaning fluid reaches the third sensor 250, which may be immediately upstream from the second valve 212 and may be an optical sensor, such as for sensing a change in turbidity in the flow in the first blood treatment segment 204 or a visual change in the fluid, the second valve 212 reconfigures from its first position to its second position. Alternatively or additionally, when the blood in the second blood treatment segment 206 reaches a fourth sensor 252, which may be immediately upstream from the second valve 212 and may be an optical sensor, such as for sensing a change in turbidity in the flow in the first blood treatment segment 204 or a visual change in the fluid, the second valve 212 reconfigures from its first position to its second position. As a result and as shown in FIG. 4, in the second operating mode blood treated by the second blood treatment device 240 flows from the second blood treatment device 240, through the fourth intermediate conduit 242, through the second valve 212, and to the outlet conduit 224 of the patient interface segment 202, which returns the treated blood to the patient P. In the second mode, the cleaning fluid, while circulating through the cleaning segment 208 and the first blood treatment segment 204, internally cleans the components of the first blood treatment segment 204. More specifically, the cleaning fluid breaks up blood clots in the first blood treatment segment 204, particularly the first blood treatment device 220. In certain embodiments, the cleaning fluid may be “backflowed” through the first blood treatment device 220 (that is, driven in the opposite direction than the illustrated direction) to facilitate debris removal in the second mode, for example forleaning the filter and channeling the loosened debris to a waste reservoir. In some embodiments, the first blood treatment device 220 may be deactivated in the second mode. In certain embodiments, the first blood treatment device 220 may additionally be cleaned by using an agitating mechanism and / or ultrasonic cleaning in the second mode.

[0031] After operating in the second mode for a time period, the system 200 changes back to the first mode to clean the second blood treatment segment 206. More specifically, the valves 210 and 212 permit fluid communication between the second blood treatment segment 206 and the cleaning segment 208 and fluid communication between the first blood treatment segment 204 and the patient interface segment 202. The system 200 may change from the second mode to the first mode in response to one or more of various inputs, similar to those described above. For example, in some embodiments and as illustrated, the second blood treatment segment 206 includes one or more sensors (illustratively, three sensors 252, 254, and 256) that sense a change of a parameter of flow through the second blood treatment segment 206. The sensors are operably coupled to the electronic controller 251 and thereby the first and second valves 210, 212. The controller 251 changes the positions of the first and second valves 210, 212, and thereby the operating mode of the system 200, in response to the sensor(s) sensing the change of the parameter of flow through the second blood treatment segment 206. In some embodiments, the fifth sensor 254 and / or the sixth sensor 256 are pressure sensors and sense the pressure of the flow in the second blood treatment segment 206. More specifically, the fifth sensor 254 and the sixth sensor 256 are positioned upstream and downstream, respectively, of the second blood treatment device 240 and thereby sense pressures at those locations and provide signals to the controller 251 . The controller 251 is programmed to determine the pressure difference in the flow across the second blood treatment device 240. If the pressure difference exceeds a threshold (for example, the same or similar threshold to that described hereinabove), it may indicate the presence or development of blood clots or blockage in the second blood treatment device 240, and in response thereto the controller 251 changes the operating mode of the system 200. In certain embodiments, the controller 251 may utilize programming or artificial intelligence to facilitate automatically changingoperating modes in the presence of an increasing clot burden, thrombus embolization, air embolus, declining post-membrane partial pressure of oxygen, declining platelet levels, and / or declining fibrinogen levels. In some embodiments, the controller 251 changes the operating mode of the system 200 after a certain time period (for example, after 12 to 24 hours of continuous operation). In certain embodiments, an operator changes the operating mode of the system 200 via the controller 251 or by manually changing the positions of the first and second valves 210, 212. During the transition from the second mode to the first mode, the controller 251 may synchronize switching of the positions of the first valve 210 and the second valve 212 in a similar manner as described above.

[0032] In certain embodiments, the cleaning fluid may be backflowed through the second blood treatment device 240 to facilitate debris removal when the system 200 returns to the first mode. In some embodiments, the second blood treatment device 240 may be deactivated when the system 200 returns to the first mode. In certain embodiments, the second blood treatment device 240 may additionally be cleaned by using an agitating mechanism and / or ultrasonic cleaning when the system 200 returns to the first mode.

[0033] The system 200 may be repeatedly reconfigured between the first and second operating modes in the manners described hereinabove. In some embodiments, the system 200 may remain operable during maintenance. More specifically, one of the first or second blood treatment segments 204, 206 may treat the blood of the patient P while an operator conducts maintenance on the other of the first or second blood treatment segments 204, 206 and / or the cleaning segment 208. Such maintenance may include, for example, replacing or repairing one or more components of the other of the first or second blood treatment segments 204, 206, particularly the first blood treatment device 220 or the second blood treatment device 240, and / or the cleaning segment 208, and / or replacing the cleaning fluid. The system 200 could track the usage of cleaning fluid based on flow out of the reservoir 232 and send a signal to notify the user that the reservoir 232 needs to be refilled or changed. In certain embodiments, the cleaning fluid is recirculated for several hours, and the cleaning fluid is then flushed from the system 200 and replaced with fresh cleaning fluid. In someembodiments, the cleaning fluid may be flushed to a waste reservoir (not shown). In some embodiments, the cleaning fluid is not recirculated but instead delivered from the reservoir 232 to the second blood treatment device 240 (in the first mode) or the first blood treatment device 220 (in the second mode) and then to the waste reservoir.

[0034] In certain embodiments, the system 200 advantageously does not deliver, or delivers relatively little of, a coagulant to the patient P. Accordingly, the system 200 advantageously reduces the likelihood of causing patient bleeding complications.

[0035] For the purposes of promoting an understanding of the principles of the invention, reference has been made to the preferred embodiments illustrated in the drawings, and specific language has been used to describe these embodiments. However, no limitation of the scope of the invention is intended by this specific language, and the invention should be construed to encompass all embodiments that would normally occur to one of ordinary skill in the art.

[0036] The particular implementations shown and described herein are illustrative examples of the invention and are not intended to otherwise limit the scope of the invention in any way. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. Numerous modifications and adaptations will be readily apparent to those skilled in this art without departing from the spirit and scope of the invention.

[0037] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e. , meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening.

[0038] The recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within therange, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein.

[0039] Terms such as “about” or “approximately”, unless otherwise defined or restricted in the specification, should be understood to define a variance of plus or minus 5%-10% to the numerical term referred to.

[0040] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not impose a limitation on the scope of the invention unless otherwise claimed. The various embodiments and elements can be interchanged or combined in any suitable manner as necessary.

[0041] The use of directions, such as forward, rearward, top and bottom, upper and lower are with reference to the embodiments shown in the drawings and, thus, should not be taken as restrictive. Reversing or flipping the embodiments in the drawings would, of course, result in consistent reversal or flipping of the terminology.

[0042] No language in the specification should be construed as indicating any nonclaimed element as essential to the practice of the invention.

[0043] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. There is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

AMENDED CLAIMS received by the International Bureau on 02 September 2025 (02.09.2025)CLAIMS1 . An extracorporeal blood treatment system, comprising: an inlet conduit and an outlet conduit; a first blood treatment device and a second blood treatment device; a cleaning segment comprising a cleaning fluid and including a first cleaning segment conduit and a second cleaning segment conduit; a first valve and a second valve; the first valve having a first inlet, a second inlet, a first outlet and a second outlet, the inlet conduit being connected to the first inlet of the first valve, the first cleaning segment conduit being connected to the second inlet of the first valve, the first outlet of the first valve being connected to the first blood treatment device, and the second outlet of the first valve being connected to the second blood treatment device; the second valve having a first inlet, a second inlet, a first outlet and a second outlet, the first inlet of the second valve being connected to the first blood treatment device, the second inlet of the second valve being connected to the second blood treatment device, the outlet conduit being connected to the first outlet of the second valve, and the second cleaning segment conduit being connected to the second outlet of the second valve; and a controller operably coupled to the first valve and the second valve, and the controller being operable to reconfigure the extracorporeal blood treatment system between in a first mode and a second mode, wherein in the first mode: the first valve is in a first position so that the first inlet of the first valve is in fluid communication with the first outlet of the first valve and the second inlet of the first valve is in fluid communication with the second outlet of the first valve, and the second valve is in its first position so that the first inlet of the second valve is in fluid communication with the first outlet of the second valve, and the second inlet of the second valve is in fluid communication with the second outlet of the second valve, the first valve and the second valve permitting blood flow from a patient, through the inlet conduit, the first blood treatment device, and the outlet conduit and back to the patient and permitting cleaning fluid flow from thecleaning segment, through the second blood treatment device, and back to the cleaning segment, wherein in the second mode: the first valve is in a second position so that the first inlet of the first valve is in fluid communication with the second outlet of the first valve and the second inlet of the first valve is in fluid communication with the first outlet of the first valve, and the second valve is in a second position so that the first inlet of the second valve is in fluid communication with the second outlet of the second valve, and the second inlet of the second valve is in fluid communication with the first outlet of the second valve, the first valve and the second valve permitting blood flow from the patient, through the inlet conduit, the second blood treatment device, and the outlet conduit and back to the patient and permitting cleaning fluid flow from the cleaning segment, through the first blood treatment device, and back to the cleaning segment, and wherein the extracorporeal blood treatment system includes at least two sensors each operable to sense a change of a parameter of one of the blood and the cleaning fluid, the first sensor of the two sensors being located downstream from the first blood treatment device and sensing a parameter of the flow out of the first blood treatment device, the controller configured to switch the first valve from its first position to its second position based on a signal from the first sensor that is indicative of a pressure drop, and the second sensor of the two sensors being located downstream from the first blood treatment device and upstream from the second valve, the second sensor sensing a change in a flow out of the first blood treatment segment, the controller configured to switch the second valve from its first position to its second position based on a signal from the second sensor.

2. The extracorporeal blood treatment system of claim 1 , wherein the first blood treatment device comprises at least one of an oxygenator, a filter, a waste plasma reservoir, and a fresh plasma reservoir.

3. The extracorporeal blood treatment system of claim 1 , wherein the first sensor is a pressure sensor operable to sense a pressure of a flow out of the first blood treatment device, and wherein the controller, upon determining a drop in pressure, switches the first valve from its first position to its second position.

4. The extracorporeal blood treatment system of claim 3, wherein there is a third sensor located upstream from the first blood treatment device, the third sensor being a pressure sensor for detecting a pressure of a flow from the first inlet conduit into the first blood treatment device, and wherein pressure drop is determined based on the controller detecting a pressure difference between the signal from the third sensor and the signal from the first sensor.

5. The extracorporeal blood treatment system of claim 4, further comprising a pump causing blood flow through the inlet conduit and the outlet conduit.

6. The extracorporeal blood treatment system of claim 5, wherein the pump is a first pump, and further comprising a second pump causing cleaning fluid flow from the cleaning segment.

7. Cancelled.

8. The extracorporeal blood treatment system of claim 1 , wherein the cleaning fluid comprises an anticoagulant.

9. The extracorporeal blood treatment system of claim 1 , wherein there are fourth, fifth and sixth sensors, the fourth sensor located upstream from the second blood treatment device, the fourth sensor being a pressure sensor for detecting a pressure of a flow from the first inlet conduit into the second blood treatment device, the fifth sensor is a pressure sensor located downstream from the second blood treatment device and senses a pressure of a flow out of the second blood treatment device, the controller configured to switch the first valve from its second position to its first position based on a pressure difference between the signal from the fifth sensor and the signal from the fourth sensor, and the sixth sensor being located downstream from the second blood treatment device and upstream from the second valve, the sixth sensor sensing a change in a flow out of the second blood treatment segment, the controller configured to switch the second valve from its second position to its first position based on a signal from the sixth sensor.

10. An extracorporeal blood treatment system, comprising: a patient interface segment configured to receive blood from a patient and deliver blood to the patient; a first blood treatment segment and a second blood treatment segment; a cleaning segment including a first cleaning segment conduit and a second cleaning segment conduit; and a first valve and a second valve; the first valve having a first inlet, a second inlet, a first outlet and a second outlet, the inlet conduit being connected to the first inlet of the first valve, the first cleaning segment conduit being connected to the second inlet of the first valve, the first outlet of the first valve being connected to the first blood treatment device, and the second outlet of the first valve being connected to the second blood treatment device; the second valve having a first inlet, a second inlet, a first outlet and a second outlet, the first inlet of the second valve being connected to the first blood treatment device, the second inlet of the second valve being connected to the second blood treatment device, the outlet conduit being connected to the first outlet of the second valve, and the second cleaning segment conduit being connected to the second outlet of the second valve; a controller operably coupled to the first valve and the second valve, the controller being operable to actuate the first valve and the second valve between first positions and second positions, wherein in the first position of the first valve, the first inlet of the first valve is in fluid communication with the first outlet of the first valve, and the second inlet of the first valve is in fluid communication with the second outlet of the first valve, and in the first position of the second valve, the first inlet of the second valve is in fluid communication with the first outlet of the second valve, and the second inlet of the second valve is in fluid communication with the second outlet of the second valve, the patient interface segment being in fluid communication with the first blood treatment segment and the cleaning segment being in fluid communication with the second blood treatment segment, wherein in the second position of the first valve, the first inlet of the first valve is in fluid communication with the second outlet of the first valve and the second inlet of the first valve is in fluid communication with the first outlet of the first valve, and inthe second position of the second valve, the first inlet of the second valve is in fluid communication with the second outlet of the second valve, and the second inlet of the second valve is in fluid communication with the first outlet of the second valve, the patient interface segment being in fluid communication with the second blood treatment segment and the cleaning segment being in fluid communication with the first blood treatment segment, and wherein the extracorporeal blood treatment system includes at least two sensors each operable to sense a change of a parameter of one of the blood and the cleaning fluid, the first sensor of the two sensors being located downstream from the first blood treatment device and sensing a parameter of the flow out of the first blood treatment device, the controller configured to switch the first valve from its first position to its second position based on a signal from the first sensor being indicative of a loss in pressure, and the second sensor of the two sensors being located downstream from the first blood treatment device and upstream from the second valve, the second sensor sensing a change in a flow out of the first blood treatment segment, the controller configured to switch the second valve from its first position to its second position based on a signal from the second sensor.11 . The extracorporeal blood treatment system of claim 10, wherein the cleaning segment comprises a cleaning fluid.

12. The extracorporeal blood treatment system of claim 11 , wherein the first sensor is a pressure sensor operable to sense a pressure of a flow out of the first blood treatment device, and wherein the controller, upon determining a drop in pressure switches the first valve from the first positions to the second positions.

13. The extracorporeal blood treatment system of claim 12, wherein the second sensor is an optical sensor configured to detect one of a change in turbidity and a visual change in a flow from the first blood treatment device and providing a signal to the controller, the controller switching the second valve from the first position to the second position based on the signal from the second sensor.

14. The extracorporeal blood treatment system of claim 13, wherein there are fourth, fifth and sixth sensors, the fourth sensor located upstream from the second blood treatment device, the fourth sensor being a pressure sensor for detecting a pressure of a flow from the first inlet conduit into the second blood treatment device, the fifth sensor is pressure sensor located downstream from the second blood treatment device and senses a pressure of a flow out of the second blood treatment device, the controller configured to switch the first valve from its second position to its first position based on a pressure difference between the signal from the fifth sensor and the signal from the fourth sensor, and the sixth sensor being located downstream from the second blood treatment device and upstream from the second valve, the sixth sensor sensing a change in a flow out of the second blood treatment segment, the controller configured to switch the second valve from its second position to its first position based on a signal from the sixth sensor.

15. The extracorporeal blood treatment system of claim 10, wherein the first sensor is a first type of sensor and the second sensor is a second type of sensor that is different from the first type of sensor.

16. Cancelled.

17. The extracorporeal blood treatment system of claim 11 , further comprising a pump causing cleaning fluid flow from the cleaning segment.

18. The extracorporeal blood treatment system of claim 10, wherein the first blood treatment segment comprises at least one of an oxygenator, a filter, a waste plasma reservoir, and a fresh plasma reservoir.

19. The extracorporeal blood treatment system of claim 10, further comprising a pump causing blood flow through the patient interface segment.

20. A method for treating a patient using an extracorporeal blood treatment system, the method comprising: operating the extracorporeal blood treatment system in a first mode, comprising: receiving blood from the patient; treating the blood using a first blood treatment device; returning the blood to the patient; circulating a cleaning fluid through a cleaning segment and a second blood treatment device; receiving a signal from a first sensor located downstream from the first blood treatment device and switching a first valve from a first position to a second position to channel flow of blood from the patient to the second blood treatment device based on the signal; receiving a signal from a second sensor located downstream from the first blood treatment device and upstream from a second valve and switching the second valve from a first position to a second position to channel flow of blood from the second blood treatment device to the patient based on the signal and operating the extracorporeal blood treatment system in a second mode, comprising: receiving blood from the patient; treating the blood using the second blood treatment device; returning the blood to the patient; and circulating the cleaning fluid through the cleaning segment and the first blood treatment device.21 . The method of claim 20, wherein the first sensor is a pressure sensor and the signal is indicative of a drop in pressure of the blood flowing from the first blood treatment device, and wherein the second sensor senses a change in the flow from the first blood treatment device indicative of a transition from blood to cleaning fluid.

22. The method of claim 20, further comprising, after operating the extracorporeal blood treatment system in the second mode, receiving a signal from a third sensor located downstream from the second blood treatment device and switching the first valve from its second position to itsfirst position based on the signal to channel flow of blood from the patient to the first blood treatment device; receiving a signal from a fourth sensor located downstream from the second blood treatment device and upstream from the second valve and switching the second valve from its second position to its first position based on the signal to channel flow of blood from the first blood treatment device to the patient and again operating the extracorporeal blood treatment system in the first mode.

23. The extracorporeal blood treatment system of claim 3, wherein the second sensor comprises an optical sensor configured to detect one of a change in turbidity and a visual change in a flow from the first blood treatment device, the second sensor providing the signal to the controller.

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