Blood dialyzer for infants and methods of use

Abstract

The present disclosure provides a manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment on blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connected to the first conduit at the double lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and a second syringe and optionally a third syringe each connected to the filter.

Description

BLOOD DIALYZER FOR INFANTS AND METHODS OF USECROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Patent Application No. 63 / 624,883, filed January 25, 2024, the contents of which are hereby incorporated by reference in its entirety for all purposes.BACKGROUND

[0002] Understanding the challenges of blood draws in infants and children is crucial to their safety and well-being. Blood volume in infants and children is significantly lower than in adults. This makes the procedure of drawing blood a delicate and critical matter. The volume of blood in a premature neonate ranges from 89 to 105 mL per kilogram of body weight, while a full-term baby has from 82 to 86 mL / kg of blood.

[0003] Guidelines suggest that for infants and children, the maximum amount of blood drawn within a 24-hour window should range between 1% and 5% of their total blood volume (TBV). Excessive or frequent blood draws, especially in a short timeframe, can lead to iatrogenic anemia, where the infant becomes anemic due to medical intervention. In neonates and critically ill children, this risk is heightened. Anemia can have a range of detrimental effects, including increased cardiac workload, hindered oxygen delivery to tissues, and potential developmental complications.

[0004] Acute kidney injury (AKI) is indicated by an acute reduction in kidney function that results in a decline in glomerular filtration rate (GFR), which leads to retention of urea and other nitrogenous waste products and loss of fluid, electrolyte, and acid-base regulation. AKI is an important contributing factor to the morbidity and mortality of critically ill neonates. Due to smaller veins, access to the venous system is difficult and blood samples must be conserved and properly handled especially during dialysis.

[0005] There is a need for dialysis systems and methods for infants and neonates. The present disclosure satisfies this need and offers other advantages as well.BRIEF SUMMARY

[0006] The present disclosure provides a blood treatment system and methods of use wherein a volume of blood is withdrawn from a patient; it passes through a filter device and is returned to the patient. The process can be repeated, processing volumes of blood through the blood filter until the entire blood volume of the patient has been treated. In certain instances, a single needle or single catheter is used for both withdrawing and returning the blood and thus one vein of the patient is punctured. In other embodiments, two vascular accesses of the patient are used.

[0007] In a first device embodiment, the present disclosure provides a manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attached to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connected to the first conduit at the double lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and a second syringe and optionally a third syringe each connected to the filter.

[0008] In another embodiment, the present disclosure provides a method for extracorporeal blood treatment, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attached to the vascular access of the patient at a first end and a firstsyringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; and a second conduit connected to the first conduit at the second lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and conveying blood via the first conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

[0009] These and other objects, aspects and embodiments will become more apparent when read with the detailed description and figures that follow.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 illustrates a diagram of an apparatus of the disclosure for blood treatment.

[0011] FIG. 2 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0012] FIG. 3 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0013] FIG. 4 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0014] FIG. 5 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0015] FIG. 6 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0016] FIG. 7 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0017] FIG. 8 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0018] FIG. 9 illustrates a diagram of an embodiment of the disclosure for blood treatment.

[0019] FIG. 10 illustrates a diagram of an embodiment of the disclosure for blood treatment.DETAILED DESCRIPTION

[0020] Systems and methods according to the present disclosure employ batch processing of blood using manual actuation to convey blood and / or fluids to affect a desired extracorporeal blood treatment, for example, hemofiltration, hemodialysis, hemodiafiltration, or hemoperfusion. For example, a series of valves can allow a first syringe to convey blood between a patient and a blood filter. The first syringe can also be used to convey other fluids or drugs to the patient. A secondary syringe can be used to apply a vacuum pressure to the filter to withdraw effluent from the blood volume as it passes along the filter pathway, or as a reservoir for fluid or blood, or to apply positive pressure to the filter. Similarly, in certain aspects, an optional third syringe can be used to apply a vacuum pressure to the filter to withdraw effluent from the blood volume as it passes along the filter pathway, or as a reservoir for fluid or blood, or to apply positive pressure to the filter.

[0021] FIG. 1 illustrates the system, apparatus, or device 100 of a first embodiment, which is schematically shown having a filter or dialyzer 128 in the center. The device 100 includes the filter 128 for performing an extracorporeal treatment on blood of a patient such as an infant undergoing dialysis by removing waste molecules and / or fluid from whole blood. A first conduit 101 conveys blood from a vascular access 106 of a patient 102 and returns treated blood to the vascular access 106. The first conduit 101 has a double lumen 114 which is attached to the vascular access 106 of the patient via the first conduit 101 at a first end and a first syringe 142 is coupled to the first conduit via a first valve 132 at the second end. The first valve is disposed between the first syringe 142 and the filter 128. The first valve also connects the first conduit. A second conduit 116 is connected to the first conduit 101 at the double lumen 114. The second conduit 116 is connected to the filter 128 and to the first valve 132. A second valve 104 is positioned between the vascular access 106 of the patient 102 and the double lumen 114. A second syringe 108 and optionally a third syringe 118 are each connected to the filter 128. Each of the valves 132 and 104 may be a manually actuated multi-position valve, such as a 3 -way stopcock. In certain aspects, the second valve 104 can be integrated into the double lumen 114.

[0022] In certain aspects, the filter 128 is a hemofilter, a dialysis filter, a hemoperfusion filter, a plasmapheresis filter, a hemoperfusion filter or a combination for treating blood flowing along the flow path through the filter. In certain aspects, the filter is a dialysis filter.

[0023] Although the present disclosure uses “blood” as an exemplary body fluid, those of skill in the art will recognize that the systems and methods of the present disclosure are also useful for other body fluids such as lymph, ascites, abdominal fluid, pleural fluid, organ fluid, spinal fluid, intestinal fluid or water. Similarly, although “vascular access” is an exemplary embodiment, a skilled artisan will recognize that abdominal access is needed for ascites, spinal canal access is needed for spinal fluid, and lymphatic access is needed for lymph.

[0024] In certain aspects, the disclosed embodiments operate with a modest vascular access (e.g., a single lumen conduit or needle of relatively small size, for example, a catheter smaller than 7 French (e.g., smaller than either 7 French, such as 6, 5, 4, or 3 French) or 17 gauge needle or smaller diameter ( e.g., 18, 19, 20, 21, 22, 23, 24, or 25 gauge). Moreover, since the disclosed embodiments rely on manual actuation, they can be used in scenarios and environments where electrical power is unavailable or unreliable, unlike conventional dialysis machines. Thus, the disclosed embodiments may improve the availability of RRT for patients with acute kidney failure (AKI) and mitigate otherwise preventable deaths. The disclosed systems are useful for treating infants. Embodiments of the disclosed subject matter may exhibit additional or different advantages or features beyond those specifically delineated above.

[0025] In certain aspects, the first valve 132 and the second valve 104 are three-way valves. The first syringe 142 is configured to apply a vacuum pressure to the vascular access 106 when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient via the first conduit 101. When the first valve 132 and the second valve 104 are in the first orientation, blood is drawn from patient 102 through the vascular access 106 and conveyed via conduit 101 and conduit 130 to first syringe 142. First syringe 142 is connected to the first valve 132 via coupler conduit 112. The vacuum pressure is applied by pulling a plunger within first syringe 142 to withdraw blood. By appropriate actuation of the first syringe 142 and control of valves 132 and 104,body fluids, blood, fluids, and / or drugs can be sequentially introduced into the flow path for processing by filtration device 128.

[0026] In certain aspects, the first syringe 142 is configured to apply a positive pressure when the first valve 132 and the second valve 104 are in a second orientation to push the withdrawn volume of blood along the treatment path second conduit 116 and into the filter 128 to return to the patient 102.

[0027] In certain aspects, when the first valve and the second valve are in a third orientation, blood flow is closed and the second syringe 108 is coupled to a drain line from the filter 128 via a third valve (not shown), and the second syringe 108 is configured to apply a vacuum pressure to drain the filter.

[0028] In certain aspects, e.g., before attachment to a patient, the system or the device can be primed with a saline, a hemofiltration fluid, a buffer, or a flushing fluid. In certain instances, a priming fluid comprises saline (e.g., isotonic saline) or a flushing liquid. Turning to FIG. 2, the priming step 200 begins by attaching an outlet of saline bag 202 or a syringe (not shown) to conduit 206. Second valve 204 can be a three-way valve and in a first orientation, allows fluid flow from 202 through conduit 206 and through double lumen 214. The fluid flows via non-treatment path 230 and to first valve 232. When first valve 232, which can be a three-way valve, is in a first orientation, the first syringe 242 is configured to apply a vacuum pressure to withdraw fluid. Arrows 223, 225 and 246 show the non-treatment flow path of the fluid.

[0029] In certain aspects, the priming step continues as is shown in FIG. 3, step 300. The fluid now within the barrel of first syringe 342, can be pushed into filter 328 when first valve is in a second position. A positive pressure from the first syringe 342 pushes the fluid along the second conduit 326 and into the filter 328. Arrows 335 and 339 show the treatment path of fluid flow.

[0030] In certain aspects, as shown in FIG. 4, step 400, the filter 428 is primed. By first including fluid in filter 428, second syringe 408 and third syringe 418 apply vacuum pressure to the filter 428 to ensure fluid is well distributed. Arrows 419 and 429 show the flow path of the fluid from filter 428.

[0031] In certain aspects, as shown in FIG. 5, step 500, the ultrafiltration (UF) side of the filter 528 is primed. As shown therein, positive pressure against the fluid in third syringe518 pushes the fluid through the UF side of the filter 528 and into syringe 508 in counterclockwise fashion. Arrows 534, 535, 538, 544 and 550 show fluid flow and direction. A skilled person would readily appreciate that fluid flow through the UF side of the filter can also be directed clockwise using the second syringe 508 to apply positive pressure.

[0032] In certain aspects, as shown in FIG. 6, step 600, blood is drawn from the patient (e.g., infant) 602 from a vascular access 601. Blood is conveyed along the first conduit pathway 606, 630 through the double lumen 614 and via 630. Arrows 622, 634, and 648 show the non-treatment path of blood flow. For blood flow, the first syringe 642 applies a vacuum pressure along this non-treatment pathway.

[0033] In certain aspects, as shown in FIG. 7, step 700, blood is conveyed through the treatment pathway conduit 726 by positive pressure from the first syringe 742 through first valve 732 and into filter 728. In other words, applying a positive pressure from the first syringe 742 when the first valve 732 and the second valve 704 are in a second orientation pushes the withdrawn volume of blood along the second conduit 726 and into the filter 728. Once in filter 728, second syringe 708 is used to apply a vacuum pressure in filter 728 to for example, dialyze or filter the blood. The second syringe 708 is filled with treated blood via arrows 766, 768 and 770. Thereafter, second syringe 708 pushes the treated blood through double lumen 714 and into conduit 706 to patient 702.

[0034] In a second device embodiment, the disclosure provides a system or device which is a double vascular access system. As disclosed in FIG. 8, system 800 has a first vascular access for removing untreated blood 861 and second vascular access 806 for returning treated blood. FIG. 8 shows a first conduit 850 for conveying blood from the first vascular access 861 of a patient 802 and a second conduit 801 for returning treated blood to a second vascular access 806, the first conduit 850 is attach to the first vascular access 861 of the patient at a first end and a first syringe 842 coupled to the first conduit 850 via a first valve 832 at the second end. The first valve 832 is between the first syringe 842 and the filter 828. The first valve 832 also connects the first conduit. A second conduit 801 connects to the filter 828 at 825 and to the first syringe 842 via the first valve 832. The second conduit between the filter 828 and first valve 832 is 816. A second valve 804 is between the vascular accesses of the patient 802, the filter 828 and the first valve 832. A second syringe 808 and optionally a third syringe 818 are each connected to the filter 828.

[0035] The present disclosure provides a method for extracorporeal blood treatment using the foregoing device, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying untreated blood from a first vascular access of a patient and a second conduit for returning treated blood passed through the filter to a second vascular access, the first conduit being attached to the first vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connecting the filter and to the first syringe via the first valve and a second valve between the first and the second vascular accesses of the patient, the filter and the first valve; and conveying blood via the first conduit by applying a vacuum pressure to the first vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

[0036] In certain aspects, applying a positive pressure from the first syringe, when the first valve and the second valve are in a second orientation, pushes the withdrawn volume of blood along the second conduit and into the filter to form treated blood. Further, a positive pressure from the first syringe pushes the treated blood into the patient.

[0037] In certain aspects, the first valve and the second valve are in a third orientation to close blood flow. The second syringe is coupled to a drain line from the filter via a third valve (not shown), and the second syringe 808 is configured to apply a vacuum pressure to drain the filter. Alternatively, the filter 828 can drain via optional syringe 818.

[0038] The elements of the second device embodiment operate substantially in similar fashion as discussed. For example, each of the valves 832 and 804 may be a manually actuated multi -position valve, such as a 3 -way stopcock. The filter 828 is a hemofilter, a dialysis filter, a hemoperfusion filter, a plasmapheresis filter, a hemoperfusion filter or a combination for treating blood flowing along the flow path through the filter. The vacuum pressure is applied by pulling a plunger within first syringe 842 to withdraw blood. Byappropriate actuation of the first syringe 842 and control of valves 832 and 804, body fluids, blood, fluids, and / or drugs can be sequentially introduced into the flow path for processing by filtration device 828. The second device embodiment has two accesses: (i) a first vascular access 861 for untreated blood and (ii) a second vascular access 806 for treated blood.

[0039] Each of the valves 832 and 804 may be a manually actuated multi-position valve, such as a 3 -way stopcock.

[0040] In a third device embodiment, the system can be a single conduit system. As disclosed in FIG. 9, system 900 has a single access and a single conduit. As illustrated therein, the disclosure provides the device including a filter 928 for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid. The device has a conduit 901 for conveying blood from a vascular access 906 of a patient 902 and for returning treated blood to the vascular access 906, the conduit attached to the vascular access of the patient 906 at a first end and a first syringe 942 coupled to the conduit via a first valve 932 at the second end, wherein the first valve 932 is between the first syringe 942 and the filter 928. There is a second valve 904 between the vascular access of the patient 906 and the filter 928. The system or device includes a second syringe 908 and optionally a third syringe 918 each connected to the filter 928.

[0041] The present disclosure provides a method for extracorporeal blood treatment using the foregoing device, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a conduit for conveying blood from a vascular access and for returning treated blood to the vascular access, the conduit attached to the vascular access of the patient at a first end and a first syringe coupled to the conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second valve between the vascular access and the filter; andconveying blood via the conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

[0042] In certain aspects, applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation pushes the withdrawn volume of blood along the conduit and into the filter to form treated blood.

[0043] In certain aspects, applying a positive pressure from the first syringe pushes the treated blood into the patient.

[0044] In certain aspects, when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from the filter via a third valve (not shown), the second syringe is configured to apply a vacuum pressure which drains the filter.

[0045] The elements of the third device embodiment operate substantially similar fashion as discussed. For example, each of the valves 932 and 904 may be a manually actuated multi-position valve, such as a 3-way stopcock. The filter 928 is a hemofilter, a dialysis filter, a hemoperfusion filter, a plasmapheresis filter, a hemoperfusion filter or a combination for treating blood flowing along the flow path through the filter. The vacuum pressure is applied by pulling a plunger within first syringe 942 to withdraw blood. By appropriate actuation of the first syringe 942 and control of valves 932 and 904, body fluids, blood, fluids, and / or drugs can be sequentially introduced into the flow path for processing by filtration device 928.

[0046] Each of the valves 932 and 904 may be a manually actuated multi-position valve, such as a 3 -way stopcock.

[0047] In a fourth device embodiment, the present disclosure provides a manual extracorporeal blood treatment device 1000 as shown in FIG. 10. The system 1000 includes a filter 1028 for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid. A first conduit 1001 for conveying blood from a vascular access 1006 of a patient and for returning treated blood to the vascular access 1006, the first conduit having a double lumen 1014 which is attached to the vascular access of the patient 1006 at a first end and a first syringe 1042 coupled to the first conduit 1001 via a first valve 1032 at the second end, wherein the first valve 1032 is between the firstsyringe 1042 and the filter 1028. A second conduit 1016 connected to the first conduit at the double lumen 1014, wherein the second conduit is connected to the filter 1028 and to the first valve 1032. A second valve 1004 is between the vascular access 1006 of the patient 1002 and the double lumen 1014. A second syringe 1031, a third valve 1036, and a drain bag 1008 are connected to the filter 1028 by a third conduit 1038. A fourth conduit 1055 connects a waste bag (e.g., for dialysate) to the filter 1018.

[0048] The present disclosure provides a method for extracorporeal blood treatment using the foregoing device, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; and a second conduit connected to the first conduit at the double lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and conveying blood via the first conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

[0049] In certain aspects, applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation pushes the withdrawn volume of blood along the second conduit and into the filter to form treated blood.

[0050] In certain aspects, a positive pressure from the first syringe pushes the treated blood into the patient.

[0051] In certain aspects, when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from thefilter via a third valve, and the second syringe is configured to apply a vacuum pressure to drain the filter.

[0052] The elements of the fourth device embodiment operate substantially similar fashion as discussed. For example, each of the valves 1032 and 1004 may be a manually actuated multi -position valve, such as a 3 -way stopcock. The filter 1028 is a hemofilter, a dialysis filter, a hemoperfusion filter, a plasmapheresis filter, a hemoperfusion filter or a combination for treating blood flowing along the flow path through the filter. The vacuum pressure is applied by pulling a plunger within first syringe 1042 to withdraw blood. By appropriate actuation of the first syringe 1042 and control of valves 1032 and 1004, body fluids, blood, fluids, and / or drugs can be sequentially introduced into the flow path for processing by filtration device 1028.

[0053] Each of the valves 1032, 1004 and 1036 may be a manually actuated multiposition valve, such as a 3 -way stopcock.

[0054] The syringes herein described hold a volume of about 5 mL to about 100 mL of fluid such as 5 mL, 10 mL, 15 mL, 20 mL, 25 mL, 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, 60 mL, 65 mL, 70 mL, 75 mL, 80 mL, 85 mL, 90 mL, 95 mL, and / or 100 mL, comprise a barrel and a plunger. In certain instances, the volume of blood of each increment processed is between about 3 mL to about 25 mL. The total volume of blood of the patient processed may be between 70 mL-2400 mL or higher as the treatment method is repeated in increments.

[0055] In certain aspects, a drug such as an anticoagulant, or an anticoagulant reversal agent can be included in the blood flow from the first syringe.

[0056] In certain aspects, the patient is an infant having a weight between about 1 kg to about 20 kg. The amount of blood volume is between 70 to 120 mL per kilogram of body weight, or 70 mL-2400 mL of total blood volume.

[0057] In certain aspects, the patient such as an infant to be treated is suffering from an indication such as hydrops fetalis, twin-twin transfusion syndrome, volume overload, acute kidney injury, or heart failure. Alternatively, the patient is an adult suffering from heart failure, acute kidney injury or volume overload.

[0058] In certain instances, the filter can be for example, an extracorporeal hemoadsorption filter device to remove cytokines from circulating blood such as a biocompatible, sorbent bead technology e.g., CytoSorb™, Cyto Sorbents™, Inc. CytoSorb hemoadsorption beads are polystyrene-divinylbenzene porous particles (450 pm avg. particle diameter, 0.8-5 nm pore diameter, 850 m2 / g surface area) with a biocompatible polyvinyl-pyrrolidone coating. See for example, US Patent No. 8,647,666 which claims a method of using a composition comprising polystyrene divinyl benzene copolymer and a polyvinyl pyrrolidone polymer.

[0059] In certain other instances, the filter is Seraph® Microbind® Affinity Blood Filter, which is a filter that allows body fluids to pass over microbeads coated with molecular receptor sites that mimic the receptors on human cells which pathogens use to colonize when they invade the body. The adsorption media is a flexible platform that uses covalently-bonded, immobilized heparin or heparan sulfate for its unique binding capacity. See, for example, US Patent Nos. 8,758,286 or 9,173,989, disclosing at least one polysaccharide adsorbent, or immobilized heparin.

[0060] In this application, unless specifically stated otherwise, the use of the singular includes the plural, and the separate use of “or” and “and” includes the other, i.e., “and / or.” Furthermore, use of the terms “including” or “having,” as well as other forms such as “includes,” “included,” “has,” or “had,” are intended to have the same effect as “comprising” and thus should not be understood as limiting.

[0061] Any range described herein will be understood to include the endpoints and all values between the endpoints. Whenever “substantially,” “approximately,” “essentially,” “near,” “about,” or similar language is used in combination with a specific value, variations up to and including 10% of that value are intended, unless explicitly stated otherwise.

[0062] It is thus apparent that there is provided, in accordance with the present disclosure, syringe-based manual extracorporeal blood treatment systems and methods employing batch processing. Many alternatives, modifications, and variations are enabled by the present disclosure. While specific examples have been shown and described in detail to illustrate the application of the principles of the present invention, it will be understood that the invention may be embodied otherwise without departing from such principles. For example, disclosed features may be combined, rearranged, omitted, etc. to produce additional embodiments, while certain disclosed features may sometimes be used toadvantage without a corresponding use of other features. Accordingly, Applicant intends to embrace all such alternative, modifications, equivalents, and variations that are within the spirit and scope of the present invention.

Claims

WHAT IS CLAIMED IS:1 A manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connected to the first conduit at the double lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and a second syringe and optionally a third syringe each connected to the filter.

2. The device of claim 1, wherein the filter is a member selected from a hemofilter, a dialysis filter, a hemoperfusion filter or a plasmapheresis filter.

3. The device of claim 1, wherein the first valve is a three-way valve.

4. The device of claim 1, wherein the second valve is a three-way valve.

5. The device of claim 1, herein the first syringe is configured to apply a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient via the first conduit.

6. The device of claim 1, wherein the first syringe is configured to apply a positive pressure when the first valve and the second valve are in a second orientation to push the withdrawn volume of blood along the second conduit and into the filter to return to the patient.

7. The device of claim 1, wherein the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drainline from the filter via a third valve, and the second syringe is configured to apply a vacuum pressure to drain the filter.

8. A manual extracorporeal blood treatment method, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; and a second conduit connected to the first conduit at the second lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and conveying blood via the first conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

9. The method of claim 8, wherein applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation to push the withdrawn volume of blood along the second conduit and into the filter to form treated blood.

10. The method of claim 9, wherein applying a positive pressure from the first syringe pushing the treated blood into the patient.

11. The method of claim 8, wherein when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from the filter via a third valve, and the second syringe is configured to apply a vacuum pressure to drain the filter.

12. The method of claim 8, wherein the filter is a member selected from a hemofilter, a dialysis filter, a hemoperfusion filter or a plasmapheresis filter.

13. The method of claim 8, wherein the patient is an infant.

14. The method of claim 13, wherein the infant has a weight between about 1 kg to about 20 kg.

15. The method of claim 13, wherein the infant is suffering from hydrops fetalis.

16. The method of claim 13, wherein the infant is suffering from twintwin transfusion syndrome.

17. The method of claim 13, wherein the infant is suffering from volume overload.

18. The method of claim 13, wherein the infant is suffering with acute kidney injury.

19. The method of claim 13, wherein the infant is suffering heart failure.

20. The method of claim 8, wherein the patient is an adult.

21. The method of claim 20, wherein the adult patient is suffering from heart failure.

22. The method of claim 20, wherein the adult patient is suffering from acute kidney injury.

23. The method of claim 20, wherein the adult patient is suffering from volume overload.

24. A manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid;a first conduit for conveying untreated blood from a first vascular access of a patient and a second conduit for returning treated blood passed through the filter to a second vascular access, the first conduit being attached to the first vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connecting the filter and to the first syringe via the first valve and a second valve between the first and the second vascular accesses of the patient, the filter and the first valve; and a second syringe and optionally a third syringe are each connected to the filter.

25. A method for extracorporeal blood treatment, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying untreated blood from a first vascular access of a patient and a second conduit for returning treated blood passed through the filter to a second vascular access, the first conduit being attached to the first vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connecting the filter and to the first syringe via the first valve and a second valve between the first and the second vascular accesses of the patient, the filter and the first valve; and conveying blood via the first conduit by applying a vacuum pressure to the first vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

26. The method of claim 25, wherein applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation to push the withdrawn volume of blood along the second conduit and into the filter to form treated blood.

27. The method of claim 26, wherein applying a positive pressure from the first syringe pushes the treated blood into the patient.

28. The method of claim 25, wherein when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from the filter via a third valve, the second syringe is configured to apply a vacuum pressure to drain the filter.

29. A manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a conduit for conveying blood from a vascular access and for returning treated blood to the vascular access, the conduit attached to the vascular access of the patient at a first end and a first syringe coupled to the conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second valve between the vascular access and the filter; and a second syringe and optionally a third syringe each connected to the filter.

30. A method for extracorporeal blood treatment, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a conduit for conveying blood from a vascular access and for returning treated blood to the vascular access, the conduit attached to the vascular access of the patient at a first end and a first syringe coupled to the conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second valve between the vascular access and the filter; and conveying blood via the conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

31. The method of claim 30, wherein applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation to push the withdrawn volume of blood along the conduit and into the filter to form treated blood.

32. The method of claim 31, wherein applying a positive pressure from the first syringe pushing the treated blood into the patient.

33. The method of claim 30, wherein when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from the filter via a third valve, the second syringe is configured to apply a vacuum pressure to drain the filter.

34. A manual extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; a second conduit connected to the first conduit at the double lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; a third valve between the filter and a drain bag; and optionally a dialysate reservoir coupled to the filter.

35. A manual extracorporeal blood treatment method, the method comprising: providing an extracorporeal blood treatment device, the device comprising: a filter for performing an extracorporeal treatment of blood passing therethrough by removing waste molecules and / or fluid; a first conduit for conveying blood from a vascular access of a patient and for returning treated blood to the vascular access, the first conduit having a double lumen which is attach to the vascular access of the patient at a first end and a first syringe coupled to the first conduit via a first valve at the second end, wherein the first valve is between the first syringe and the filter; anda second conduit connected to the first conduit at the second lumen, wherein the second conduit is connected to the filter and to the first valve; a second valve between the vascular access of the patient and the double lumen; and conveying blood via the first conduit by applying a vacuum pressure to the vascular access when the first valve and the second valve are both in a first orientation to withdraw a volume of blood from the patient.

36. The method of claim 35, wherein applying a positive pressure from the first syringe when the first valve and the second valve are in a second orientation to push the withdrawn volume of blood along the second conduit and into the filter to form treated blood.

37. The method of claim 36, wherein applying a positive pressure from the first syringe pushes the treated blood into the patient.

38. The method of claim 35, wherein when the first valve and the second valve are in a third orientation to close blood flow and the second syringe is coupled to a drain line from the filter via a third valve, and the second syringe is configured to apply a vacuum pressure to drain the filter.

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