Modular medical fluid management assemblies and associated apparatuses and methods

Abstract

To provide a fluid management apparatus for medical fluid delivery.SOLUTION: A medical fluid management assembly includes a pneumatic manifold forming pneumatic passageways, a pneumatic valve chamber and a pneumatic pump chamber, the valve chamber in pneumatic communication with the passageway, the pump chamber in pneumatic communication with the passageway. The assembly also includes a fluid manifold including multiple fluid pathways, a fluid valve chamber in selective fluid communication with a fluid pump chamber and a fluid pathway, wherein (a) the pneumatic valve chamber and the fluid valve chamber are mated together to compress a membrane and (b) the pneumatic pump chamber and the fluid pump chamber are mated together to compress a membrane, wherein the pneumatic valve chamber or the pneumatic pump chamber extends from the at least one plate, or the fluid valve chamber or the fluid pump chamber extends from the fluid manifold to aid in compressing the membranes.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS]

[0001] This application claims priority to U.S. Patent Application Nos. 15 / 723,921 and 15 / 723,773, both filed on October 3, 2017, and both of which are incorporated herein by reference. [Background technology]

[0002]

[0002] The present disclosure relates generally to fluid management devices, systems, and methods. More particularly, the present disclosure relates to fluid management devices, systems, and methods for medical fluid delivery, such as blood, dialysate, substitution fluid, or intravenous drug delivery.

[0003]

[0003] Due to various causes, the human renal system can fail. Renal failure leads to several physiological disturbances. It is then impossible to maintain water and mineral balance or to manage the daily metabolic load. Toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) can accumulate in the blood and tissues.

[0004]

[0004] Kidney failure and reduced kidney function are treated with dialysis, which removes waste products, toxins, and excess water from the body that would otherwise be removed by normally functioning kidneys. Dialysis treatment, which replaces kidney function, is lifesaving and essential for many people.

[0005]

[0005] One type of renal dysfunction therapy, hemodialysis ("HD"), removes waste products from a patient's body, typically by diffusion. Diffusion occurs due to a diffusion gradient created in a semi-permeable dialyzer between the blood and an electrolyte solution called the dialysate or dialysate.

[0006] Hemofiltration ("HF") is another renal replacement therapy that relies on convective transport of toxins from the patient's blood. HF is achieved by adding replacement or substitution fluid (typically 10-90 liters of fluid) to the extracorporeal circuit during treatment. The replacement fluid, and any fluid accumulated by the patient between treatments, is ultrafiltered during HF treatment, providing a convective transport mechanism that is particularly beneficial in removing middle and large molecules. (In hemodialysis, trace amounts of waste products are removed with the fluid obtained between dialysis sessions, but the solute drugs removed by ultrafiltration are insufficient to provide convective clearance.)

[0007] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF, like standard hemodialysis, uses dialysate flowing through a dialyzer to provide diffusive clearance, and substitution fluid is delivered directly to the extracorporeal circuit to provide convective clearance.

[0008]

[0008] Most HD (HF, HDF) treatments are performed in centers. Today, there is a trend toward home hemodialysis ("HHD"), in part because it can be performed daily, offering therapeutic benefits over in-center hemodialysis treatments, which are typically performed every two or three weeks. Studies have shown that more frequent treatments remove more toxins and waste products than patients who receive less frequent, but potentially longer, treatments. Patients who receive more frequent treatments do not experience the same down-cycling as in-center patients, who accumulate two or three days' worth of toxins before treatment. In certain regions, even the nearest dialysis center can be many miles from a patient's home, resulting in door-to-door treatment times consuming a significant portion of the day. HHD can be performed at night or during the day, when patients have time to relax, work, or be productive.

[0009] Another type of kidney dysfunction therapy is peritoneal dialysis, in which a dialysis solution, also called dialysate, is infused into a patient's peritoneal cavity via a catheter. The dialysate contacts the peritoneal membrane of the cavity. Waste, toxins, and excess water move from the patient's bloodstream through the peritoneal membrane and into the dialysate by diffusion and osmosis, creating an osmotic gradient across the membrane. Osmotic agents in dialysis create the osmotic gradient. The used or spent dialysate is then pumped out of the patient, removing the waste, toxins, and excess water from the patient. This cycle may be repeated, for example, multiple times.

[0010] There are various types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. In this treatment, the patient manually connects an implanted catheter to a drain to allow used or spent dialysate to drain from the peritoneal cavity. The patient then connects the catheter to a fresh dialysate bag and infuses the fresh dialysate into the patient through the catheter. The patient then disconnects the catheter from the fresh dialysate bag and allows the dialysate to dwell in the peritoneal cavity to move waste, toxins, and excess water. After the dwell period, the patient repeats the manual dialysis procedure, for example, four times a day, with each treatment lasting approximately one hour. Manual peritoneal dialysis requires significant patient time and effort, leaving ample room for improvement.

[0011] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis treatment includes drain, fill, and dwell cycles. However, APD devices perform these cycles automatically, usually while the patient sleeps. APD devices eliminate the need for patients to manually perform treatment cycles or transport supplies during the day. APD devices are fluidly connected to an implanted catheter, a fresh dialysate source or bag, and a fluid drain. The APD device pumps fresh dialysate from the dialysate source through the catheter and into the patient's peritoneal cavity. The APD device also allows the dialysate to dwell within the peritoneal cavity and displace waste, toxins, and excess water. The source may include multiple sterile dialysis solution bags.

[0012] APD devices pump used or spent dialysate from the peritoneal cavity through a catheter to a drain. Similar to the manual process, multiple drain, fill, and dwell cycles occur during dialysis. A "final fill" occurs at the end of APD and remains in the patient's peritoneal cavity until the next treatment.

[0013] In any of the above modes of using automated equipment, it is desirable to provide a unit that is safe, reliable, fully functional, cost-effective, and, where possible, reduces waste. With respect to reliability and safety, it is desirable for the equipment to operate within safety limits, while ensuring that the limits are sufficiently broad so that the equipment can operate without constant alarms or interruptions due, for example, to a sensed parameter falling outside a narrowly defined range. Reliability also depends on robustness, for example, providing actuation and / or process fluid connections and seals that are easily generated and sustained under pressure. Performance includes the likelihood of meeting treatment goals and overall feasibility, such as ease of setup and control. Cost-effectiveness and waste are related. Often, payment for treatment using the equipment includes reimbursement. In these (or any) cases, it is desirable to reduce waste costs by reducing the amount of waste and / or recycling the waste.

[0014]

[0014] Therefore, there is a need for an automated medical fluid device that improves on at least some of the above metrics. For example, it would be desirable to have a medical fluid device that is simpler, more modular, less expensive to manufacture, easier to assemble or disassemble, e.g., at home, and / or easier to maintain. Modularizing components of a medical fluid device, for example, allows for the use of parts and subassemblies in future generations of the device and related products. Summary of the Invention

[0015] The examples described herein disclose automated systems and methods applicable to fluid delivery for, for example, plasmapheresis, hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), continuous renal replacement therapy ("CRRT"), apheresis, autologous blood transfusion, hemofiltration for sepsis, and extracorporeal membrane oxygenation ("ECMO") therapy. The systems and methods described herein may also be applicable to peritoneal dialysis ("PD") and intravenous drug delivery. These modalities, collectively or more or less individually, may be referred to as medical fluid delivery.

[0016] Additionally, the assemblies, devices, and methods described herein may each be adapted for use in clinical or home applications. For example, the assemblies may be employed in an in-center HD, HF, or HDF device that operates throughout the day. Alternatively, the assemblies may be used in conjunction with a home HD, HF, or HDF device that operates at the patient's convenience. Home systems that can be improved in accordance with the present disclosure include those described in U.S. Patent No. 8,029,454 (the '454 patent), entitled "High Convection Home Hemodialysis / Hemofiltration And Sorbent System," filed November 4, 2004, and issued October 4, 2011, to the assignee of the present application, the entire contents of which are incorporated herein by reference.

[0017]

[0017] Modular fluid management assemblies, devices, and methods are provided in this disclosure. In one embodiment, the modular fluid assembly is pneumatically operated. The assembly may employ three main components: a pump and valve component (sometimes referred to herein as a pump and valve engine), a pneumatic manifold, and a fluid (e.g., blood, dialysate, fluid concentrate, and / or water) manifold. In one embodiment, the pump and valve component or engine is in contact with both fluid and air. In one embodiment, the pneumatic manifold is in contact only with air and does not allow for fluid leakage. In one embodiment, the fluid manifold is in contact only with fluid and does not allow for air entrainment or leakage.

[0018] In one embodiment, the pump valve engine includes an air side and a fluid side separated by a flexible membrane (representing either a flexible membrane, a sheet, or a diaphragm) or multiple flexible membranes sealed to one or more rigid structures. A pneumatic manifold is positioned on (e.g., coupled to) the air side of the pump valve engine, while a fluid manifold is positioned on (e.g., coupled to) the fluid side of the manifold. In one embodiment, the air side of the engine defines pump valve ports extending in sealing communication with each pump valve recess defined by the pneumatic manifold. In one embodiment, the fluid side of the engine defines pump valve ports extending in sealing communication with each pump valve recess defined by the pneumatic manifold. The ports and recesses of the pump valve engine and one or both of the air manifold and / or fluid manifold may alternatively be reversed.

[0019] In one embodiment, the pneumatic manifold is constructed of a machined or molded material, such as metal or plastic, and is typically disposable, though reusable. The machined pneumatic manifold may include multiple machined plates sealed together, for example, by compressible gaskets. One or more of the plates may have machined pneumatic passages that significantly reduce the amount of pneumatic tubing required to route positive and negative air pressure to various desired locations in the pump and valve engine (or vent to atmosphere). Because the pneumatic manifold is non-reusable and may contain many narrow machined pneumatic passages, it is important to prevent fluids from leaking into the pneumatic manifold. For this reason, multiple flexible membranes may be used simultaneously in the pump and valve engine. The additional flexible membrane(s) provide redundancy against fluid leakage, significantly reducing the chance of fluids, such as dialysate or water, entering the pneumatic manifold.

[0020]

[0020] The pump / valve engine and fluid manifold are disposable because they come into contact with process fluids, such as dialysis fluid and / or water. Disposable can mean a single use or multiple uses with sterilization procedures performed between each use. Because the engine and fluid manifold are disposable, they are often constructed of biocompatible rigid plastic or other relatively inexpensive, liquid-tight materials and are manufactured using mass production methods, such as injection molding. As previously mentioned, the pump / valve engine will have one or more flexible membranes that perform the pumping and valving functions. The one or more flexible membranes may be constructed of flexible rubber or plastic, such as silicone or polyvinyl chloride ("PVC"). The one or more flexible membranes may be solvent bonded, radio frequency welded, heat sealed, and / or mechanically fastened to the rigid portion of the pump / valve engine.

[0021]

[0021] The pump-valve engine may provide additional fluid storage containers, such as a balance chamber, a water accumulation chamber, one or more mixing chambers, and / or a water or dialysate degassing chamber, sometimes referred to as an air trap. The balance chamber, water accumulation chamber, mixing chamber, and water or dialysate degassing chamber each differ from pumps and valves in that they are not connected to a pneumatic manifold but instead include one or more connections to a fluid manifold. The balance chamber balances the flow of unused and used dialysate to the blood circuit (e.g., the dialysis machine). Two balance chambers may be provided to ensure a relatively constant flow of unused and used fluid to the blood circuit. The water accumulator stores a constant amount of purified water in case of temporary increases in demand. The balance chamber and water accumulator may each employ a flexible membrane. The mixing chamber mixes water with a concentrate, such as a liquid acid concentrate, or water with a concentrate, such as a powdered bicarbonate concentrate containing an acid concentrate. The degassing chamber is shaped to remove and collect air from the water or dialysate flowing through the chamber.

[0022] In one embodiment, a rigid (e.g., plastic) fluid manifold eliminates the need for a flexible membrane. The fluid manifold defines a fluid path (e.g., a rigid fluid path) leading to the inlet and outlet ports. The fluid manifold may also sealingly and removably receive a fluid component, such as an ultrafilter, with the goal of eliminating as much fluid tubing as possible. It is contemplated that the fluid tubing may be down-optimized to include tubing for: (i) a purified water inlet; (ii) a liquid concentrate inlet; (iii) a fresh dialysate inlet to the extracorporeal circuit (e.g., the dialyzer); (iv) a spent dialysate outlet from the extracorporeal circuit (e.g., the dialyzer); (v) a fresh dialysate inlet to the dialysate holding tank; (vi) a fresh dialysate outlet from the dialysate holding tank; and (vii) a drain line connectable to a separate drain fluid manifold that is separately replaceable from the fluid manifold.

[0023] In one embodiment, the fluid manifold is a single fluid manifold for each of the multiple process fluids involved, such as blood, purified water, liquid concentrate, and dialysate. In alternative embodiments, separate fluid manifolds may be provided for the separate fluids (e.g., separate manifolds for blood, purified water, and liquid concentrate, and a fourth manifold for dialysate). In this manner, the separate fluid manifolds may be individually replaced as needed. For example, the dialysate manifold may be replaced more frequently than the purified water manifold or the liquid concentrate.

[0024] In one embodiment, the pump and valve engine is a single pump and valve engine for each of the multiple process fluids involved, such as blood, purified water, liquid concentrate, and dialysate. In an alternative embodiment, separate pump and valve engines may be provided for the separate fluids (e.g., separate engines for blood, purified water, and liquid concentrate, and a fourth engine for dialysate). In this manner, the separate pump and valve engines may be individually replaced as needed. For example, a pump and valve engine with the most pumps and valve chambers may be replaced more frequently than a pump and valve engine with fewer pumps and valve chambers.

[0025] In one embodiment, the pneumatic manifold is a single pneumatic manifold for each of the multiple process fluids involved, such as blood, purified water, liquid concentrate, and dialysate. A single pneumatic manifold may be used in conjunction with a single fluid manifold and / or a single pump and valve engine. Alternatively, a single pneumatic manifold may be used in conjunction with multiple fluid manifolds and / or multiple pump and valve engines. In alternative embodiments, separate pneumatic manifolds may be provided for the separate fluids (e.g., separate manifolds for blood, purified water, and liquid concentrate, and a fourth manifold for dialysate). In one embodiment, separate pneumatic manifolds are used in conjunction with separate fluid manifolds and separate pump and valve engines. Here, separate modular assemblies (each comprising a pneumatic manifold, pump and valve engine, and fluid manifold) may be located in different convenient portions of the overall medical fluid or dialysis system.

[0026]

[0026] In another alternative embodiment, a single modular assembly may include multiple fluid manifolds, multiple pump and valve engines, and multiple pneumatic manifolds. For example, two fluid manifolds may be adjacent to each other. Two pneumatic manifolds may be positioned outside the modular assembly, with two pump and valve assemblies sandwiched between the inner fluid manifold and the outer pneumatic manifold. In another embodiment, two pneumatic manifolds may be adjacent to each other. Two fluid manifolds may be positioned outside the modular assembly, with two pump and valve assemblies sandwiched between the inner pneumatic manifold and the outer fluid manifold.

[0027] The modular assemblies disclosed herein may be adapted to pump different fluids at once. Examples of the above include dialysate (fresh and used), water, and liquid concentrates. In another example, the modular assemblies may alternatively or additionally pump blood. In one embodiment, a blood set, including both the pump-valve engine and the blood manifold structure, is sealed to one side of a pneumatic manifold. That side of the manifold may be positioned at the front of a corresponding device, allowing a patient or user to removably position the blood set relative to the front of the device into sealing engagement with the pneumatic manifold. The blood set may be held in place at the front of the device by a releasable spring clamp.

[0028]

[0028] The modular assemblies of the present disclosure may be sealingly and releasably fastened and held together by bolts, clamps, or a combination thereof. The rigid portions of the pump-valve engine and fluid manifold may have metal inserts to receive the bolt heads in countersunk holes and to provide internal threads to receive the externally threaded ends of the bolts and prevent cracking. The machined metal pneumatic manifold may have recesses to countersink the bolt heads and / or internal threads to receive the externally threaded ends of the bolts. The fluid and pneumatic passages, pump chambers, valve chambers, and other components of the pump-valve engine are positioned and routed so as not to intersect with the bolts. The external clamp may be a clamp that applies a compressive clamping force using a clamp that moves with the assembly and / or a portion of the device housing.

[0029]

[0029] As discussed in more detail below, in an alternative embodiment, the pump and valve engine is partially or completely eliminated from any of the embodiments described herein.

[0030]

[0030] In light of the disclosure herein, in a first aspect of the present disclosure, which may be combined with any other aspect set forth herein unless otherwise specified without limiting the disclosure in any way, a medical fluid management assembly comprises: (i) a pneumatic manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; (ii) a pump-valve engine including a plurality of valve chambers and at least one pump chamber, the pump-valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the pneumatic manifold, and further including a plurality of fluid connectors; and (iii) a fluid manifold including a plurality of fluid passages and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the pump-valve engine.

[0031]

[0031] In a second aspect of the present disclosure, which can be combined with any other aspect described in this specification unless otherwise specified, the pneumatic manifold further includes at least one pneumatic supply source connector for connection to at least one pneumatic supply source.

[0032]

[0032] In a third aspect of the present disclosure, which can be combined with any other aspect described herein unless otherwise specified, the fluid manifold includes at least one inlet / outlet connector for connection to fluid tubing.

[0033]

[0033] In a fourth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the multiple pneumatic connectors of the pump-valve engine are ports that engage with multiple pneumatic connectors of the pneumatic manifold, the ports including recesses.

[0034]

[0034] In a fifth aspect of the present disclosure, which may be combined with the fourth aspect in combination with any other aspect described herein unless otherwise specified, the pneumatic manifold provides an O-ring seal that extends around or within the recess to seal the port of the pump-valve engine.

[0035]

[0035] In a sixth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the multiple fluid connectors of the pump-valve engine are ports that engage with the multiple fluid connectors of the fluid manifold, which include recesses.

[0036]

[0036] In a seventh aspect of the present disclosure, which can be combined with the sixth aspect in combination with any other aspect described herein unless otherwise specified, the fluid manifold provides an O-ring seal that extends around or within the recess to seal the port of the pump-valve engine.

[0037]

[0037] In an eighth aspect of the present disclosure, which may be combined with any other aspect described in this specification unless otherwise specified, the pneumatic manifold includes a plurality of integrally engaged plates, at least one of the plates defining a groove that forms a pneumatic passage.

[0038]

[0038] In a ninth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the pump-valve engine includes a first rigid plate and a second rigid plate at least partially separated by at least one flexible membrane.

[0039]

[0039] In a tenth aspect of the present disclosure, which can be combined with the ninth aspect in combination with any other aspect described in this specification unless otherwise specified, the first rigid plate and the second rigid plate are separated in areas defining the pump chamber and the valve chamber by at least one flexible membrane.

[0040]

[0040] In an eleventh aspect of the present disclosure, which can be combined with the tenth aspect in combination with any other aspect described in this specification unless otherwise specified, the first rigid plate and the second rigid plate further define at least one of an equilibrium chamber, a water accumulation chamber, a mixing chamber, a water degassing chamber, and a dialysate degassing chamber.

[0041]

[0041] In a twelfth aspect of the present disclosure, which may be combined with any other aspect herein unless otherwise specified, a fluid manifold includes at least one rigid plate that forms a plurality of fluid paths.

[0042]

[0042] In a thirteenth aspect of the present disclosure, which can be combined with any other aspect described in this specification unless otherwise specified, the fluid manifold includes a plurality of rigid plates sealed together to form a plurality of fluid paths.

[0043]

[0043] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the medical fluid management assembly comprises a plurality of pneumatic manifolds each including a plurality of pneumatic connectors sealingly and releasably engaged with pneumatic connectors of the pump-valve engine.

[0044]

[0044] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the medical fluid management assembly comprises a plurality of fluid manifolds each including a plurality of fluid connectors sealingly and releasably engaged with fluid connectors of the pump-valve engine.

[0045]

[0045] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the medical fluid management assembly comprises a plurality of pump-valve engines, each including a plurality of pneumatic connectors sealingly and releasably engaged with pneumatic connectors of a pneumatic manifold.

[0046]

[0046] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, a medical fluid management assembly includes a plurality of pump-valve engines, each including a plurality of fluid connectors sealingly and releasably engaged with a fluid connector of a fluid manifold.

[0047]

[0047] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect herein unless otherwise specified, the pneumatic manifold is a first pneumatic manifold and the pump valve engine is a first pump valve engine comprising a second pneumatic manifold including a plurality of pneumatic connectors, and a plurality of fluid connectors, and the second pump valve engine including a plurality of pneumatic connectors engaged with the pneumatic connectors of the second pneumatic manifold.

[0048]

[0048] In a 19th aspect of the present disclosure, which may be combined with the 18th aspect in combination with any other aspect described herein unless otherwise specified, the fluid connector of the second pump-valve engine engages with the fluid connector of the fluid manifold.

[0049]

[0049] In a twentieth aspect of the present disclosure, which may be combined with the eighteenth aspect in combination with any other aspect described herein unless otherwise specified, the fluid manifold comprises a first fluid manifold and a second fluid manifold including a plurality of fluid connectors, and the fluid connectors of the second pump-valve engine engage with the fluid connectors of the second fluid manifold.

[0050]

[0050] In a 21st aspect of the present disclosure, which may be combined with any other aspect described herein unless otherwise specified, the fluid manifold is a first fluid manifold and the pump valve engine is a first pump valve engine comprising a second fluid manifold including a plurality of fluid connectors, a plurality of pneumatic connectors, and a plurality of fluid connectors engaged with the fluid connectors of the second fluid manifold.

[0051]

[0051] In a 22nd aspect of the present disclosure, which can be combined with the 21st aspect in combination with any other aspect described in this specification unless otherwise specified, the pneumatic connector of the pump-valve engine engages with the pneumatic connector of the pneumatic plate.

[0052]

[0052] In a 23rd aspect of the present disclosure, which may be combined with any other aspect described in this specification unless otherwise specified, the medical fluid management assembly includes at least one pneumatic valve attached to a pneumatic plate.

[0053]

[0053] In a 24th aspect of the present disclosure, which may be combined with any other aspect described in this specification unless otherwise specified, the medical fluid management assembly includes a fluid pumping cassette removably attached to a pneumatic plate.

[0054] In a twenty-fifth aspect of the present disclosure, which may be combined with any other aspect herein unless otherwise specified, a medical fluid device includes: (i) an air pressure source; (ii) a purified water line; (iii) a liquid concentrate line; (iv) an extracorporeal circuit inlet fresh dialysate line; (v) an extracorporeal circuit outlet spent dialysate line; (vi) a drain line; and (vii) (a) an air pressure manifold in air pressure communication with the air pressure source and including a plurality of air pressure passages and a plurality of air pressure connectors; and (b) a pump-valve engine including a plurality of valve chambers and at least one pump chamber. and (c) a fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the pump and valve engine, the fluid manifold being in fluid communication with at least one of a purified water line, a liquid concentrate line, an extracorporeal circuit inlet fresh dialysate line, an extracorporeal circuit outlet spent dialysate line, and a drain line.

[0055]

[0055] In a 26th aspect of the present disclosure, which may be combined with the 25th aspect in combination with any other aspect set forth in this specification unless otherwise specified, the extracorporeal circuit outlet used dialysate line is a dialysis machine outlet line, and optionally, the extracorporeal circuit inlet unused dialysate line is a dialysis machine inlet line.

[0056]

[0056] In a 27th aspect of the present disclosure, which can be combined with the 25th aspect in combination with any other aspect described in this specification unless otherwise specified, the fluid manifold is fluidly connected to each of the purified water line, the liquid concentrate line, the extracorporeal circuit inlet unused dialysate line, the extracorporeal circuit outlet used dialysate line, and the drain line.

[0057]

[0057] In a 28th aspect of the present disclosure, which may be combined with the 25th aspect in combination with any other aspect set forth in this specification unless otherwise specified, the medical fluid device comprises a plurality of fluid manifolds, and the purified water line, the liquid concentrate line, the extracorporeal circuit inlet unused dialysate line, the extracorporeal circuit outlet used dialysate line, and the discharge line are each fluidly connected to one of the plurality of fluid manifolds.

[0058]

[0058] In a 29th aspect of the present disclosure, which may be combined with the 28th aspect in combination with any other aspect described in this specification unless otherwise specified, the fluid connectors of each fluid manifold engage with fluid connectors of the pump-valve engine.

[0059]

[0059] In a 30th aspect of the present disclosure, which may be combined with the 28th aspect in combination with any other aspect described herein unless otherwise specified, the medical fluid device comprises a plurality of pump-valve engines, each having a plurality of pneumatic connectors and a plurality of fluid connectors, and the fluid connectors of each fluid manifold engage with the fluid connector of one of the pump-valve engines.

[0060]

[0060] In a thirty-first aspect of the present disclosure, which may be combined with the thirty-first aspect in combination with any other aspect described in this specification unless otherwise specified, the pneumatic connectors of each pump-valve engine are engaged with pneumatic connectors of the pneumatic manifold.

[0061]

[0061] In a thirty-second aspect of the present disclosure, which may be combined with the thirty-first aspect in combination with any other aspect described herein unless otherwise specified, the medical fluid device comprises a plurality of pneumatic manifolds, each having a plurality of pneumatic connectors, and the pneumatic connector of each pump-valve engine engages with the pneumatic connector of one of the pneumatic manifolds.

[0062]

[0062] In a thirty-third aspect of the present disclosure, which may be combined with any other aspect herein unless otherwise specified, a medical fluid device includes: (i) a first medical fluid management assembly positioned in a first portion of the medical fluid device, the first medical fluid management assembly including: (a) a first pneumatic manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; (b) a first pump-valve engine including a plurality of valve chambers and at least one pump chamber, the first pump-valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the first pneumatic manifold, and further including a plurality of fluid connectors; and (c) a first fluid management assembly including a plurality of fluid passages and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the first pump-valve engine. and (ii) a second medical fluid management assembly positioned in a second portion of the medical fluid device, the second medical fluid management assembly comprising: (a) a second pneumatic manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; (b) a second pump-valve engine including a plurality of valve chambers and at least one pump chamber, the second pump-valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the second pneumatic manifold, and further including a plurality of fluid connectors; and (c) a second fluid manifold including a plurality of fluid passages and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the second pump-valve engine.

[0063]

[0063] In a thirty-fourth aspect of the present disclosure, which may be combined with any other aspect herein unless otherwise specified, a medical fluid management assembly (i) comprises a plurality of plates sealed together to form a plurality of pneumatic passages, at least one of the plates forming a pneumatic valve chamber and a pneumatic pump chamber, the pneumatic valve chamber in pneumatic communication with at least one of the pneumatic passages, and the pneumatic pump chamber in pneumatic communication with at least one of the pneumatic passages; (ii) a fluid manifold including a plurality of fluid paths, the fluid manifold forming the fluid valve chambers and the fluid pump chambers, the fluid valve chambers selectively in fluid communication with at least one of the fluid pump chambers and the fluid paths; (a) the pneumatic valve chambers and the fluid valve chambers integrally engage to apply pressure to at least one flexible valve chamber membrane or a valve chamber area of ​​at least one common flexible membrane; (b) a medical fluid management assembly including a plurality of pneumatic passages, the pneumatic valve chambers and the fluid pump chambers selectively in fluid communication with at least one of the fluid pump chambers and the fluid passages; The pressure pump chamber and the fluid pump chamber are integrally engaged to apply pressure to the pump chamber area of ​​the at least one flexible pump membrane or the at least one common flexible membrane, and (iii) at least one of: (a) the pneumatic valve chamber extends from the at least one plate to help apply pressure to the corresponding at least one flexible membrane or at least one flexible membrane area; (b) the pneumatic pump chamber extends from the at least one plate to help apply pressure to the corresponding at least one flexible membrane or at least one flexible membrane area; (c) the fluid valve chamber extends from the manifold to help apply pressure to the corresponding at least one flexible membrane or at least one flexible membrane area; and (d) the fluid pump chamber extends from the fluid manifold to help apply pressure to the corresponding at least one flexible membrane or at least one flexible membrane area.

[0064]

[0064] In a thirty-fifth aspect of the present disclosure, which can be combined with the thirty-fourth aspect in combination with any other aspect described in this specification unless otherwise specified, a plurality of pneumatic passages are formed in at least one of the plates and sealed by a gasket compressed between the plates.

[0065]

[0065] In a 36th aspect of the present disclosure, which can be combined with the 34th aspect in combination with any other aspect listed in this specification unless otherwise specified, the fluid manifold includes a plurality of fluid plates, at least one of which forms a plurality of fluid paths, and the fluid plates are sealed together to seal the fluid paths.

[0066]

[0066] In a 37th aspect of the present disclosure, which can be combined with the 34th aspect in combination with any other aspect listed in this specification unless otherwise specified, the medical fluid management assembly includes at least one electrically actuated pneumatic solenoid valve secured to the pneumatic manifold and selectively in pneumatic communication with at least one of the pneumatic passages.

[0067]

[0067] In a thirty-eighth aspect of the present disclosure, which may be combined with the thirty-fourth aspect in combination with any other aspect described herein unless otherwise specified, the medical fluid management assembly comprises at least one conductivity sensor having a conductive insert held by a fluid manifold, the insert being positioned along one of the fluid paths, the conductivity sensor further having a conductive conductivity probe held by the pneumatic manifold, the conductivity probe engaged with the conductive insert.

[0068]

[0068] In a thirty-ninth aspect of the present disclosure, which may be combined with the thirty-fourth aspect in combination with any other aspect described herein unless otherwise specified, the pneumatic valve chamber and fluid valve chamber are a first pneumatic valve chamber and fluid valve chamber, and include a second pneumatic valve chamber and a second fluid valve chamber, the second fluid valve chamber being selectively in fluid communication with the first balance chamber, and the first balance chamber being separated from the second balance chamber by at least one balance chamber membrane or a balance chamber area of ​​at least one common flexible membrane.

[0069]

[0069] In a fortieth aspect of the present disclosure, which can be combined with the thirty-ninth aspect in combination with any other aspect listed in this specification unless otherwise specified, the first fluid valve chamber is selectively fluidly connected to the second fluid valve chamber.

[0070]

[0070] In a forty-first aspect of the present disclosure, which can be combined with the thirty-ninth aspect in combination with any other aspect described in this specification unless otherwise specified, the first balance chamber and the second balance chamber are provided as part of a fluid manifold.

[0071]

[0071] In a forty-second aspect of the present disclosure, which may be combined with the thirty-fourth aspect in combination with any other aspect set forth in this specification unless otherwise specified, the medical fluid management assembly comprises a water accumulation chamber, the water accumulation chamber having at least one water accumulation chamber membrane or at least one common flexible membrane water accumulation chamber area for expanding when water increases in the chamber and for contracting when water decreases in the chamber.

[0072]

[0072] In a forty-third aspect of the present disclosure, which can be combined with the forty-second aspect in combination with any other aspect described in this specification unless otherwise specified, the water accumulation chamber is selectively fluidly connected to the fluid valve chamber.

[0073]

[0073] In a forty-fourth aspect of the present disclosure, which can be combined with the forty-second aspect in combination with any other aspect listed in this specification unless otherwise specified, the water accumulation chamber is provided as part of the fluid manifold.

[0074]

[0074] In a forty-fifth aspect of the present disclosure, which can be combined with the thirty-fourth aspect in combination with any other aspect listed in this specification unless otherwise specified, the medical fluid management assembly comprises a mixing chamber having a plurality of fluid inlets and fluid outlets.

[0075]

[0075] In a forty-sixth aspect of the present disclosure, which can be combined with the forty-fifth aspect in combination with any other aspect listed in this specification unless otherwise specified, the mixing chamber is selectively fluidly connected to the fluid valve chamber.

[0076]

[0076] In a forty-seventh aspect of the present disclosure, which may be combined with the forty-fifth aspect in combination with any other aspect listed herein unless otherwise specified, the mixing chamber is provided as part of the fluid manifold.

[0077]

[0077] A forty-eighth aspect of the present disclosure, which may be combined with the thirty-fourth aspect in combination with any other aspect described herein unless otherwise specified, is one of: (i) the pneumatic manifold is a first pneumatic manifold and includes a second pneumatic manifold operating in conjunction with the fluid manifold; and (ii) the fluid manifold is a first fluid manifold and includes a second fluid manifold operating in conjunction with the pneumatic manifold.

[0078]

[0078] In a forty-ninth aspect of the present disclosure, which can be combined with the thirty-fourth aspect in combination with any other aspect described in this specification unless otherwise specified, the fluid manifold includes a purification filter selectively in fluid communication with the fluid pump chamber.

[0079]

[0079] In a fiftieth aspect of the present disclosure which may be combined with any other aspect herein unless otherwise specified, a medical fluid management assembly (i) comprises a pneumatic manifold including a plurality of plates sealed together to form a plurality of pneumatic passages, at least one of the plates forming a first pneumatic valve chamber, a second pneumatic valve chamber, and a pneumatic pump chamber, the first pneumatic valve chamber being in pneumatic communication with at least one of the pneumatic passages, the second pneumatic valve chamber being in pneumatic communication with at least one of the pneumatic passages, and the pneumatic pump chamber being in pneumatic communication with at least one of the pneumatic passages; and (ii) a fluid manifold including a plurality of fluid paths, the fluid manifold forming a first fluid valve chamber, a second fluid valve chamber, a fluid pump chamber, a first balance chamber, and a second balance chamber, the first fluid valve chamber being in pneumatic communication with at least one of the fluid pump chamber and the fluid paths. a second fluid valve chamber in selective fluid communication with at least one of the first balance chamber and the fluid path; (a) the first pneumatic valve chamber and the first fluid valve chamber integrally engage to apply pressure to a first valve chamber area of ​​the at least one first flexible valve chamber membrane or the at least one common flexible membrane; (b) the second pneumatic valve chamber and the second fluid valve chamber integrally engage to apply pressure to a second valve chamber area of ​​the at least one second flexible valve chamber membrane or the at least one common flexible membrane; (c) the pneumatic pump chamber and the fluid pump chamber integrally engage to apply pressure to a pump chamber area of ​​the at least one flexible pump membrane or the at least one common flexible membrane; and (d) the first balance chamber and the second balance chamber integrally engage to apply pressure to a balance chamber area of ​​the at least one balance chamber membrane or the at least one common flexible membrane.

[0080]

[0080] In a 51st aspect of the present disclosure, which can be combined with the 50th aspect in combination with any other aspect listed in this specification unless otherwise specified, the medical fluid management assembly includes a third pneumatic valve chamber and a third fluid valve chamber integrally engaged to apply pressure to at least one third flexible valve chamber membrane or a third valve chamber area of ​​at least one common flexible membrane, and the third fluid valve chamber is selectively in fluid communication with the second balance chamber.

[0081]

[0081] In a 52nd aspect of the present disclosure, which can be combined with the 51st aspect in combination with any other aspect described in this specification unless otherwise specified, the first fluid valve chamber is selectively fluidly connected to (i) the second fluid valve chamber and (ii) the third fluid valve chamber.

[0082]

[0082] In a 53rd aspect of the present disclosure which may be combined with the 51st aspect in combination with any other aspect listed in this specification unless otherwise specified, the medical fluid management assembly of claim 51 includes: (i) a fourth pneumatic valve chamber and a fourth fluid valve chamber integrally engaged to apply pressure to a fourth valve chamber area of ​​at least one fourth flexible valve chamber membrane or at least one common flexible membrane, wherein the fourth fluid valve chamber is selectively in fluid communication with the first balance chamber; and (ii) a fifth pneumatic valve chamber and a fifth fluid valve chamber integrally engaged to apply pressure to a fifth valve chamber area of ​​at least one fifth flexible valve chamber membrane or at least one common flexible membrane, wherein the fifth fluid valve chamber is selectively in fluid communication with the second balance chamber.

[0083] In a fifty-fourth aspect of the present disclosure which may be combined with any other aspect herein unless otherwise specified, a medical fluid system comprises a first medical fluid management assembly and a second medical fluid management assembly, wherein: (i) the first medical fluid management assembly (a) comprises a first pneumatic manifold including a plurality of plates sealed together to form a plurality of pneumatic passageways, at least one of the plates forming a pneumatic valve chamber and a pneumatic pump chamber, the pneumatic valve chamber in pneumatic communication with at least one of the pneumatic passageways, and the pneumatic pump chamber in pneumatic communication with at least one of the pneumatic passageways; (b) comprises a first fluid manifold including a plurality of fluid paths, the first fluid manifold forming a fluid valve chamber and a fluid pump chamber, the fluid valve chamber selectively in fluid communication with at least one of the fluid pump chambers and the fluid paths; (c) the pneumatic valve chamber and the fluid valve chamber are integrally engaged to apply pressure to at least one flexible valve chamber membrane or a valve chamber area of ​​at least one common flexible membrane; and (d) (ii) a second medical fluid management assembly comprising: (a) a second pneumatic manifold including a plurality of plates sealed together to form a plurality of pneumatic passageways, at least one of the plates defining a pneumatic valve chamber and a pneumatic pump chamber, the pneumatic valve chamber in pneumatic communication with at least one of the pneumatic passageways, and the pneumatic pump chamber in pneumatic communication with at least one of the pneumatic passageways; (b) a second fluid manifold including a plurality of fluid paths, the second fluid manifold defining a fluid valve chamber and a fluid pump chamber, the fluid valve chamber in selective fluid communication with at least one of the fluid pump chambers and the fluid paths; (c) the pneumatic valve chamber and the fluid valve chambers integrally engage to apply pressure to at least one of the flexible valve chamber membranes or the valve chamber area of ​​the at least one common flexible membrane; and (d) the pneumatic pump chamber and the fluid pump chambersintegrally engaging to apply pressure to the pump chamber area of ​​at least one flexible pump membrane or at least one common flexible membrane;

[0084]

[0084] In a 55th aspect of the present disclosure, which may be combined with the 54th aspect in combination with any other aspect listed in this specification unless otherwise specified, the first fluid manifold is a purified water manifold arranged and configured to transport purified water, and the second fluid manifold is a dialysate manifold arranged and configured to transport dialysate.

[0085]

[0085] In a 56th aspect of the present disclosure, which can be combined with the 55th aspect in combination with any other aspect listed in this specification unless otherwise specified, the purified water manifold is positioned adjacent to the concentrate source, while the dialysate manifold is positioned adjacent to the dialysate heater.

[0086]

[0086] In a 57th aspect of the present disclosure, which may be combined with the 54th aspect in combination with any other aspect listed in this specification unless otherwise specified, the first fluid manifold is a dialysate manifold arranged and configured to transport dialysate, and the second fluid manifold is a blood manifold arranged and configured to transport blood.

[0087]

[0087] In a fifty-eighth aspect of the present disclosure, which can be combined with the fifty-seventh aspect in combination with any other aspect listed in this specification unless otherwise specified, the blood manifold is positioned adjacent to the dialysis machine.

[0088]

[0088] In a fifty-ninth aspect of the present disclosure, any of the structures and functions disclosed with respect to Figures 1 to 19B may be combined with any of the other structures and functions disclosed with respect to Figures 1 to 19B.

[0089]

[0089] In light of the present disclosure and the above aspects, it is an advantage of the present disclosure to provide improved medical fluid management assemblies, devices, and methods.

[0090] Another advantage of the present disclosure is that it provides a modular and scalable medical fluid management assembly.

[0091] Another advantage of the present disclosure is that it provides a medical fluid management assembly with a reduced component count.

[0092] Yet another advantage of the present disclosure is that it provides a medical fluid management assembly that is relatively easy to use, maintain, assemble, and test.

[0093] Another advantage of the present disclosure is that it provides a medical fluid management assembly that is robust and self-sustaining without the need for a device housing.

[0094] Yet another advantage of the present disclosure is that it provides a medical fluid management assembly that is flexible with respect to pneumatic and fluid routing.

[0095] The advantages described herein may be found in one or some, but perhaps not all, of the embodiments disclosed herein. Additional features and advantages are described herein and will become apparent from the following detailed description and drawings. [Brief explanation of the drawings]

[0096] [Figure 1] FIG. 1 is a schematic diagram of one embodiment of renal failure therapy employing any of the modular fluid management systems and methods of the present disclosure. [Figure 2] FIG. 1 is a perspective view of one embodiment of a blood set of the present disclosure. [Figure 3] FIG. 1 is a side cross-sectional view of an air-operated water, dialysate, liquid concentrate, blood, or other medical fluid pump of one embodiment of a medical fluid management assembly of the present disclosure. [Figure 4] FIG. 10 is a side cross-sectional view of an air-operated water, dialysate, liquid concentrate, blood, or other medical fluid pump of another embodiment of the medical fluid management assembly of the present disclosure. [Figure 5] FIG. 10 is a side cross-sectional view of an air-operated water, dialysate, liquid concentrate, blood, or other medical fluid pump of another embodiment of the medical fluid management assembly of the present disclosure. [Figure 6] FIG. 10 is a side cross-sectional view of one embodiment of a balance chamber of any of the medical fluid management assemblies of the present disclosure. [Figure 7] FIG. 10 is a side cross-sectional view of another embodiment of a balance chamber of any of the medical fluid management assemblies of the present disclosure. [Figure 8] FIG. 10 is a side cross-sectional view of one embodiment of a water accumulator of any of the medical fluid management assemblies of the present disclosure. [Figure 9] FIG. 10 is a side cross-sectional view of one embodiment of a mixing chamber of any of the medical fluid management assemblies of the present disclosure. [Figure 10] 1 is a side cross-sectional view of one embodiment of a conductivity probe integrated with an exemplary medical fluid management assembly of the present disclosure and one embodiment holding various components of the fluid management assembly together. FIG. [Figure 11] FIG. 1 is a side cross-sectional view of one embodiment integrating an electrically actuated pneumatic valve with an exemplary medical fluid management assembly of the present disclosure. [Figure 12] FIG. 12 is a schematic diagram of one embodiment incorporating the structure of FIGS. 3-11 to form any of the medical fluid management assemblies of the present disclosure. [Figure 13] FIG. 4 is a schematic elevation view of the medical fluid management assembly of FIG. 3. [Figure 14] FIG. 10 is a schematic elevation view of another embodiment of a medical fluid management assembly of the present disclosure operating in a renal failure therapy system. [Figure 15] FIG. 15 is a schematic elevation view of the medical fluid management assembly of FIG. 14 performing an alternative direct blood or medical fluid therapy. [Figure 16] FIG. 10 is a schematic elevation view of another embodiment of a medical fluid management assembly of the present disclosure operating in a renal failure therapy system. [Figure 17] FIG. 10 is a schematic elevation view of yet another embodiment of a medical fluid management assembly of the present disclosure illustrating the modularity of the system. [Figure 18A] FIG. 10 is a schematic elevation view of another embodiment of a medical fluid management assembly of the present disclosure, further illustrating the modularity of the system. [Figure 18B] FIG. 10 is a schematic elevation view of another embodiment of a medical fluid management assembly of the present disclosure, further illustrating the modularity of the system. [Figure 18C] FIG. 10 is a schematic elevation view of another embodiment of a medical fluid management assembly of the present disclosure, further illustrating the modularity of the system. [Figure 19A] 16 is a schematic elevational view illustrating an alternative fastening structure for use with the exemplary medical fluid management assembly of FIGS. 14 and 15. FIG. [Figure 19B] 16A-16C are schematic top / bottom views illustrating alternative fastening structures for use with the exemplary medical fluid management assembly of FIGS. 14 and 15. DETAILED DESCRIPTION OF THE INVENTION

[0097] System Hardware

[0115] The examples described herein are applicable to any medical fluid therapy system that delivers blood, dialysate, substitution fluid, purified or sterile water, liquid concentrates, or intravenous medications. These examples are particularly suited to renal dysfunction therapies, such as all forms of peritoneal dialysis ("PD"), hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), and continuous renal replacement therapy ("CRRT"), which are collectively or more or less individually referred to herein as renal failure therapies. Furthermore, any of the devices and modular fluid management systems and methods described herein may be adapted for use in a clinical or home environment. For example, the devices and modular fluid management systems and methods may be employed in an in-center HD system that operates continuously substantially throughout the day. Alternatively, they may be adapted for use in a home HD system that can operate overnight, for example, while the patient is asleep. Furthermore, each of the renal failure therapy examples described herein may include a diffusion membrane or filter, such as a dialysis machine for HD or HDF or a hemofilter for HF.

[0098]

[0116] Referring now to FIG. 1, this figure illustrates one embodiment of a renal failure therapy system 10 employing any of the modular fluid management assemblies and methods described herein and using an HD machine 90. Overall, the system 10 is shown to have a simplified type of dialysate or process fluid delivery circuit. The blood circuit is also simplified. It should be understood that the circuitry has been simplified to facilitate explanation of this disclosure, and that implementations of the system will have other structures and functions, as seen in the above-incorporated publications.

[0099]

[0117] The system 10 of FIG. 1 includes a blood circuit 20. The blood circuit 20 withdraws blood from and returns blood to the patient 12. Blood is withdrawn from the patient 12 via an arterial line 14 and returned to the patient via a venous line 16. The arterial line 14 includes an arterial line connector 14a that connects to an arterial needle 14b in blood draw flow communication with the patient 12. The venous line 16 includes a venous line connector 16a that connects to a venous needle 16b in blood return flow communication with the patient. The arterial line 14 and the venous line 16 also include line clamps 18a and 18v, which may be spring-loaded, fail-safe, mechanical gripping clamps. In one embodiment, the line clamps 18a and 18v are automatically closed in an emergency situation.

[0100]

[0118] Arterial line 14 and venous line 16 also include air or bubble detectors 22a and 22v, which may be ultrasonic air detectors. Air or bubble detectors 20a and 20v look for air in arterial line 14 and venous line 16, respectively. If air is detected by one of air detectors 22a and 22v, system 10 closes line clamps 18a and 18v, pauses the blood and dialysate pumps, and instructs the patient to remove the air so treatment can resume.

[0101]

[0119] In the illustrated embodiment, a blood pump 30 is positioned in the arterial line 14. In the illustrated embodiment, the blood pump 30 includes a first blood pump chamber 30a and a second blood pump chamber 30b. The blood pump chamber 30a operates with an inlet valve 32i and an outlet valve 32o. The blood pump chamber 30b operates with an inlet valve 34i and an outlet valve 34o. In one embodiment, the blood pump chambers 30a and 30b are each blood receptacles including a rigid (e.g., spherical) shell within which a flexible diaphragm is positioned to form a diaphragm pump. One side of each diaphragm receives blood, while the other side of each diaphragm operates with positive or negative air pressure (or is vented to atmosphere). Alternatively, the blood pump 30 is a peristaltic pump that operates in conjunction with the tubing of the arterial line 14.

[0102]

[0120] In the illustrated embodiment, a heparin vial 24 and a heparin pump 26 are positioned between the blood pump 30 and a hemofilter 40 (e.g., a dialysis machine). The heparin pump 26 can be a pneumatic pump or a syringe pump (e.g., a stepper motor-driven syringe pump). Providing heparin upstream of the hemofilter 40 helps prevent clotting of the hemofilter membrane.

[0103]

[0121] Control unit 50 includes one or more processors and memory and receives air detection signals from air detectors 22a and 22v (as well as other sensors in system 10, such as temperature sensors, blood leak detectors, conductivity sensors, pressure sensors, and access disconnection transducer 92) and controls components such as line clamps 18a and 18v, blood pump 30, heparin pump 26, and dialysate pump.

[0104]

[0122] Blood exiting hemofilter 40 via venous line 16 flows through air trap 28. Air trap 28 removes air from the dialyzed blood before it is returned to patient 12 via venous line 16, as discussed in more detail below.

[0105]

[0123] In the hemodialysis version of the system 10 of FIG. 1 , dialysate is pumped along the outside of the membrane of the hemofilter 40, while blood is pumped through the inside of the membrane of the hemofilter. Fresh dialysate is prepared by purifying water via a water purification unit 60. Suitable water purification units include those described in U.S. Patent Application Publication No. 2011 / 0197971, "Water Purification System and Method," filed April 25, 2011, the entire contents of which are incorporated herein by reference. In one embodiment, the water purification unit includes a filter or other structure that purifies tap water (e.g., removes pathogens and ions such as chlorine) so that, in one embodiment, the water has less than 0.03 endotoxin units / ml ("EU / ml") and less than 0.1 colony-forming units / ml ("CFU / ml"). The water purification unit 60 can be provided in a housing separate from the housing of the hemodialysis machine, including the blood circuit 20 and the dialysate circuit 70.

[0106]

[0124] In the illustrated embodiment, the dialysate circuit 70 includes a water accumulation chamber 42. Purified water from the purification unit 60 is stored in the water accumulation chamber 42. The water accumulation chamber 42 provides excess water for the water pump 44 in the event that the demand for purified water increases for any reason.

[0107]

[0125] In one embodiment, purified water from water purification unit 60 is pumped along water line 62 through water accumulation chamber 42 and bicarbonate cartridge 72. Acid from container 74 is pumped along acid line 62 into mixing chamber 52, with bicarbonate flowing from bicarbonate cartridge 72, to form an electrolytic and physiologically compatible dialysis solution. The pumps and temperature-compensated conductivity sensors used to properly mix the purified water with the bicarbonate and acid are discussed below.

[0108]

[0126] The dialysate circuit 70 provides a hemofilter inlet or fresh dialysate pump 64. In one embodiment, the fresh dialysate pump 64 is configured similarly to the blood pump 30. Like the pump 30, the fresh dialysate pump 64 includes a pair of pump chambers (shown as one pump chamber 66, which again can be spherically configured), each operating with an inlet valve chamber 68i and an outlet valve chamber 68o. Like the blood pump 30, the pump chambers 66 alternately operate such that one pump chamber 66 fills with HD dialysate while the other pump chamber 66 discharges HD dialysate.

[0109]

[0127] Pump 64 is a hemofilter inlet dialysate pump. In one embodiment, a second dual-chamber pump 94 similar to pump 64 is positioned at or before the outlet line 82 to push spent dialysate to a drain. The spent dialysate pump 94 includes dual chambers 96 (only one shown), each operating with an inlet valve chamber 98i and an outlet valve chamber 98o.

[0110]

[0128] A third chamber pump 44 is provided to pump purified water from the water accumulation chamber 42 through the bicarbonate cartridge 72. The purified water pump 44 may also include two pump chambers 46 (only one shown), each operating with an inlet valve chamber 48i and an outlet valve chamber 48o.

[0111]

[0129] A fourth chamber pump 54 is provided to pump acid from the acid container 74 to the acid line. The acid pump 54 may include a pump chamber 56 operating in conjunction with an inlet valve chamber 58i and an outlet valve chamber 58o. The acid pump 54 may have only one pump chamber 56, since in one embodiment continuous pumping is less important in the acid line due at least in part to the contribution of a buffer dialysate tank 53 located between the mixing chamber 52 and the hemofilter dialysate pump 64.

[0112]

[0130] A fifth pod pump 104 in the exhaust line 82 is used to remove a known amount of ultrafiltrate ("UF") when HD therapy is being delivered. The UF pump 104 includes a pump chamber 106 that operates in conjunction with an inlet valve chamber 108i and an outlet valve chamber 108o. The system 10 controls and monitors the UF pump 104 to control and know the amount of ultrafiltrate removed from the patient. The system 10 ensures that the required amount of ultrafiltrate is removed from the patient by the end of treatment.

[0113]

[0131] Alternatively, any one or more of the pumps described above may be peristaltic pumps that operate in conjunction with tubing.

[0114]

[0132] 1 also shows that the dialysate is pumped along fresh dialysate line 76, through heater 78 and ultrafilter 80, to hemofilter 40, after which the used dialysate is pumped to a drain by discharge line 82. Heater 78 heats the dialysate to body temperature, or approximately 37° C. Ultrafilter 80 further cleans and purifies the dialysate before it reaches hemofilter 40, removing any germs or contaminants introduced by, for example, bicarbonate cartridge 72 or acid container 74.

[0115]

[0133] In the illustrated embodiment, the dialysate circuit 70 also includes a sample port 84. The dialysate circuit 70 may further include a blood leak detector (not shown, but used to detect whether the fibers of the blood filter 40 have torn).

[0116]

[0134] In the illustrated embodiment, fluid balancing for the dialyzer 40 is performed by balance chambers 86a and 86b and corresponding valve 88. The valves are arranged so that spent dialysate fills one of the balance chambers 86a and 86b, pushing an equal amount of fresh dialysate to the dialyzer 40, while fresh dialysate fills the other balance chamber 86a and 86b, pushing an equal amount of spent dialysate to the drain line 82. The roles of the two balance chambers 86a and 86b are then reversed to maintain a relatively constant flow of fresh fluid to the dialyzer 40 and spent fluid to the drain line 82. The balance chambers 86a and 86b ensure that the amount of fresh fluid to the dialyzer 40 and the amount of spent fluid to the drain line 82 are largely equal. A UF ​​pump 104 is located in a parallel drain line (not shown) leading from the dialyzer 40. In one embodiment, the UF pump uses a smaller, more precise pump chamber to accurately measure the amount of UF from the patient 12.

[0117]

[0135] In the illustrated embodiment, the hemodialysis system 10 is an online pass-through system, which passes the dialysate through a hemofilter once and then pumps the dialysate to a drain after use. Both the blood circuit 20 and the dialysate circuit 70 may be hot water sterilized after each treatment to allow for reuse. In one embodiment, the blood circuit 20, including the hemofilter 40, is hot water sterilized and reused daily for approximately one month, while the dialysate circuit 70 is hot water sterilized and reused for approximately six months. To perform other procedures such as sterilization and priming, in one embodiment, both the arterial line 14 and the venous line 16 are connected to a drain cassette 102 located in the drain line 82. Once the arterial line 14 and the venous line 16 are plugged into the drain cassette 102, sterilizing water and priming dialysate may be circulated throughout the blood circuit 20 and the dialysate circuit 70 on both sides of the dialyzer 40 to ensure complete sterilization or priming.

[0118]

[0136] In an alternative embodiment, for example, in the case of CRRT, multiple bags or infusion equipment of sterile dialysate are grouped together and used alternately. In such cases, an empty supply bag may function as a drain or spent fluid bag. In another alternative embodiment, substitution fluid from balance chambers 86a and 86b may flow directly to arterial line 14 and venous line 16 of extracorporeal circuit 20 instead of to dialyzer 40.

[0119]

[0137] The device 90 of the system 10 includes a housing as shown by the dotted line in Figure 1. The housing of the device 90 depends on the type of treatment, such as whether the treatment is in-center or home treatment, whether the dialysate / infusion equipment is supplied in batch (e.g., bagged) or online, etc. Although not shown in Figure 1, the front of the housing of the device 90 may include structure configured to releasably fasten the air trap 28.

[0120]

[0138] 2 further illustrates that the device 90 of the system 10 of FIG. 1 can operate with a blood set 100. The blood set 100 includes the arterial line 14, the venous line 16, the heparin vial 24 and heparin pump 26 / blood pump 30, the blood filter 40 (e.g., a dialyzer), and the air trap 28. The air trap 28 may be positioned in the venous line 16 to remove air from the blood before it is returned to the patient 12. Alternatively or additionally, one or more air traps 28 may be positioned in the water line 62, the fresh dialysate line 76, and / or elsewhere in the dialysate circuit 70 to improve mixing and / or remove air from the fresh dialysate line before it reaches the filter or dialyzer 40. In one embodiment, the dialysate circuit components 70 may be positioned mostly inside the device 90, while the blood set 100 may be mounted external to the device.

[0121]

[0139] 1 , the primary purified water components of device 90 of system 10 include water accumulation chamber 42 and water pump 44. The primary mixing components of device 90 of system 10 include bicarbonate cartridge 72 and mixing chamber 52 (note that acid container 74 is not retained in device 90, but could be in alternative embodiments). The primary dialysate components of device 90 of system 10 include dialysate holding tank 53, fresh dialysate pump 64, heater 78, ultrafilter 80, balance chambers 86a and 86b, and spent dialysate pump 94. The primary blood moving components of blood set 100 include dialyzer 40, air trap 28, and blood / heparin pump 30 / 26.

[0122]

[0140] In one embodiment, it is contemplated that a single medical fluid management assembly may be provided that houses all of the purified water, mixing, and dialysate components, while operating the blood set 100 separately, as shown in Figure 2. In an alternative embodiment, a single medical fluid management assembly may be provided that operates the blood set 100 for all of the purified water, mixing, and dialysate components. In another alternative embodiment, a first medical fluid management assembly may be provided for the purified water and mixing components, and a second medical fluid management assembly may be provided for the dialysate component, while operating the blood set 100 separately, as shown in Figure 2. In another alternative embodiment, a first medical fluid management assembly may be provided for the purified water and mixing components, and a second medical fluid management assembly may be provided for the dialysate component, while operating the blood set 100 in conjunction with one of the first and second medical fluid management assemblies. In yet another alternative embodiment, a first medical fluid management assembly is provided for the purified water component, a second medical fluid management assembly is provided for the mixing component, and a third medical fluid management assembly is provided for the dialysate component, while the blood set 100 operates separately, as shown in Figure 2. In yet another alternative embodiment, a first medical fluid management assembly is provided for the purified water component, a second medical fluid management assembly is provided for the mixing component, and a third medical fluid management assembly is provided for the dialysate component, while the blood set 100 operates in conjunction with one of the first, second, and third medical fluid management assemblies. Alternatively, in any of the above-described embodiments in which a separate medical fluid management assembly is provided for the dialysate component, the medical fluid management assembly may be further divided into separate fresh dialysate and spent fluid assemblies.

[0123]

[0141] In one embodiment, the pumps are pneumatically actuated pumps each operating with an inlet valve and an outlet valve. Specifically, the purified water pump 44 operates with an inlet valve chamber 48i and an outlet valve chamber 48o, and the acid pump 54 operates with an inlet valve chamber 58i and an outlet valve chamber 58o. The fresh dialysate pump 64 operates with an inlet valve chamber 68i and an outlet valve chamber 68o. The spent dialysate pump 94 operates with an inlet valve chamber 98i and an outlet valve chamber 98o. The blood pump 30 operates with an inlet valve chamber 32i / 34i and an outlet valve chamber 32o, 34o. In one embodiment, the UF pump (not shown) may operate in a similar manner.

[0124]

[0142] Each of the pumps may have pump chambers 46, 56, 66, 96, 106, and 30a, 30b of the same size. Alternatively, any of the pump chambers 46, 56, 66, 96, 106, and 30a, 30b may be of different sizes. For example, the pump chambers of the liquid acid pump 44 and the UF pump 104 may be smaller than the other pump chambers. Regardless, each of the pumps 44, 54, 64, 94, 30, and 104 may be configured as shown in any of FIGS. 3-5. That is, each of the pumps 44, 54, 64, 94, 30, and 104 may have any of the structures, functions, and alternatives discussed with respect to any of FIGS. 3-5. For each pump, the inlet valve is open and the outlet valve is closed while a negative pressure is applied to the pump membrane to draw fluid into the pump. The inlet valve is closed and the outlet valve is open while a positive pressure is applied to the pump membrane to expel fluid from the pump.

[0125]

[0143] Any of the water line 62, concentrate line, dialysate line 76, spent dialysate or drain line 82, arterial blood line 14, and / or venous blood line may include pneumatic valves in addition to the inlet and outlet valves associated with pumps 44, 54, 64, 94, 30, and 104. For example, balance chambers 86a and 86b include corresponding valves 88. Any of these additional valves may have any of the structures, functions, and alternatives discussed with respect to the pneumatically actuated valves of FIGS.

[0126]

[0144] Other major components of device 90 of system 10 are not air-operated, such as water accumulation chamber 42, bicarbonate cartridge 72, mixing chamber 52, dialysate holding tank 53, heater 78, ultrafilter 80, balance chambers 86a and 86b, dialyzer 40, and air trap 28. Of these components, bicarbonate cartridge 72, dialysate holding tank 53, and heater are provided with device 90, but may also be received outside of and in fluid communication with one or more medical fluid management assemblies of system 10. Ultrafilter 80 may or may not be provided with one or more medical fluid management assemblies, as discussed in more detail below.

[0127]

[0145] 3, which is a cross-sectional view of pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of a medical fluid management assembly 110a of the present disclosure. In the illustrated embodiment, the medical fluid management assembly 110a includes three main components: a pneumatic manifold 120a, a pump and valve engine 160a, and a fluid manifold 200a.

[0128]

[0146] In one embodiment, pneumatic manifold 120a includes metal plates or pieces 122a, 124a, 126a, 128a, and 130a, which may be machined aluminum, steel, stainless steel, and combinations thereof. Alternatively, metal plates or pieces 122a, 124a, 126a, 128a, and 130a may be constructed of a plastic material, such as molded plastic. Metal plates or pieces 122a, 124a, 126a, 128a, and 130a, when adjacent, may be removably bolted together using bolts and nuts and / or mating internal threads.

[0129]

[0147] Metal plates or pieces 122a and 124a together define a pneumatic pumping groove 132a that selectively conveys positive or negative pressure (or vents to atmosphere) to the pneumatic pump chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal plate 128a defines an inlet valve groove 134a that selectively conveys positive or negative pressure (or vents to atmosphere) to the inlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal piece 126a defines an outlet valve groove 136a that selectively conveys positive or negative pressure (or vents to atmosphere) to the outlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104.

[0130]

[0148] Metal plate 128a defines inlet valve O-ring seat 138a that sealingly retains inlet valve O-ring 144. Metal piece 126a defines outlet valve O-ring seat 139a that sealingly retains outlet valve O-ring 144. Metal piece 122a defines pump chamber O-ring seat 142a that sealingly retains pump chamber O-ring 144.

[0131]

[0149] A gasket 146a is compressed between metal piece 122a and metal plate 128a to seal pneumatic grooves or passages (e.g., groove or passage 134a) formed in metal piece 122a and / or metal plate 128a. A gasket 148a is compressed between metal piece 122a and metal plate 120a to seal pneumatic grooves or passages (e.g., groove or passage 132a) formed in metal piece 122a and / or metal plate 120a. A gasket 150a is compressed between metal piece 124a and metal piece 126a to seal pneumatic grooves or passages (e.g., grooves or passages 132a and 136a) formed in metal piece 124a and / or metal piece 126a. Gaskets 146a, 148a, and 150a may be, for example, compressible silicone. Gaskets 146a, 148a, and 150a may be individual gaskets or may be provided as part of a common flexible sheet or membrane that comprises other gaskets or gasket areas.

[0132]

[0150] The pneumatic grooves or passages lead to electrically actuated pneumatic solenoid valves (not shown) that may be spring-loaded closed when de-energized and open when energized. The electrically actuated pneumatic solenoid valves selectively allow positive on / off pressure, negative on / off pressure, positive variable pressure, and / or positive variable pressure to reach (or be vented to) the inlet pneumatic valve chamber, the outlet pneumatic valve chamber, or the pneumatic pump chamber (or may be vented to atmosphere) under electrical control by control unit 50 (FIG. 1). The electrically actuated pneumatic solenoid valves may be mounted to pneumatic manifold 120a.

[0133]

[0151] The pump and valve engine 160a of pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of the medical fluid management assembly 110a includes pneumatic caps 162a, 164a, and 166a and fluidic piece 180a. Caps 162a, 164a, and 166a and fluidic piece 180a may each be constructed of a rigid, medically safe plastic, such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like. Metal cross sections are generally depicted herein as having uniform hatching, while plastic cross sections have thin / bold hatching. Materials that contact blood or dialysate are biocompatible and disinfected or sterilized as needed.

[0134]

[0152] Pneumatic caps 162a, 164a, and 166a define the inlet pneumatic valve chamber, outlet pneumatic valve chamber, and pneumatic pump chamber, respectively, for pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of medical fluid management assembly 110a. Each of pneumatic caps 162a, 164a, and 166a sealingly mates with a respective O-ring 144 and is adjacent to a mating groove or passage (e.g., groove 134a, groove 136a, and groove 132a) to define a pneumatic port as shown that provides an airtight connection between pump and valve engine 160a and pneumatic manifold 120a.

[0135]

[0153] In the illustrated embodiment, fluid piece 180a provides mating fluid chambers 182a, 184a, and 186a. Inlet fluid valve chamber 182a mates with inlet pneumatic valve cap 162a. Outlet fluid valve chamber 184a mates with outlet pneumatic valve cap 164a. Fluid pump chamber 186a mates with pneumatic pump cap 166a. Inlet fluid valve chamber 182a, outlet fluid valve chamber 184a, and fluid pump chamber 186a each sealingly mate with a respective O-ring 144 and adjacent to a mating fluid path of fluid manifold 200a to define a fluid port as shown that provides a fluid-tight connection between pump and valve engine 160a and fluid manifold 200a.

[0136]

[0154] In the illustrated embodiment, fluid piece 180a is formed with fluid conduit sections 188a, i.e., a first fluid conduit section 188a connecting inlet fluid valve chamber 182a and fluid pump chamber 186a, and a second fluid conduit section 188a connecting fluid pump chamber 186a and outlet fluid valve chamber 184a. In one embodiment, inlet fluid valve chamber 182a, outlet fluid valve chamber 184a, fluid pump chamber 186a, and fluid conduit section 188a are molded as a single structure. For example, there may be two sizes: a larger size for blood pump 30, water pump 44, and dialysate pumps 64 and 94, and a smaller size for heparin pump 26, acid pump 54, and UF pump 104. Alternatively, three or more different sizes may be provided (e.g., a third, smaller size for heparin pump 26).

[0137]

[0155] It will be appreciated that although the pump and valve chambers are shown as being spherical for ease of illustration, any or all of the pump and valve chambers may have alternative shapes, such as elliptical or oval.

[0138]

[0156] One or more flexible membranes or sheets 190, 192 are positioned between pneumatic caps 162a, 164a, and 166a and fluid piece 180a. Membranes or sheets 190, 192 may be composed of, for example, polyvinyl chloride (“PVC”), polyethylene, Kraton, or polyolefin, or another medically safe, flexible plastic or rubber. Membranes or sheets 190, 192 may be flat and stretch upon actuation, or may have the same or similar shape as pneumatic caps 162a, 164a, and 166a and / or inlet fluid valve chamber 182a, outlet fluid valve chamber 184a, and fluid pump chamber 186a, with a preform or pre-dome so that they flap back and forth instead of stretching.

[0139]

[0157] It is important to prevent fluid leakage into the pneumatic manifold 120a. Therefore, it is contemplated that two or more layers or sheets 190, 192 may be provided to accommodate for the possibility of one tearing, developing a pinhole, becoming misaligned, etc. It is also contemplated that each membrane 190, 192 may be pressure tested before each treatment by applying positive air pressure to the inside of the pneumatic caps 162a, 164a, and 166a, isolating the pneumatic lines leading to the pneumatic caps 162a, 164a, and 166a, and monitoring the pressure in the isolated area to look for pressure decay. In this manner, a leaking membrane or sheet 190, 192 may be detected before medical fluid is introduced into the fluid strip 180a.

[0140]

[0158] To capture fluid leaks that occur during treatment, it is possible to provide one or more of: (i) electrical contact sensors formed in an insulating housing (not shown) in the pneumatic grooves or passages 132a, 134a, 136a (which detect the presence or absence of a conductive liquid such as dialysate or blood filling the circuit); (ii) capacitive or inductive sensors (not shown) in the pneumatic grooves or passages 132a, 134a, 136a (which detect the presence or absence of a liquid such as water, dialysate, or blood that alters the electric field); or (iii) a memory containing known pressure spikes that occur when the non-leaking membranes 190, 192 are in tight contact with the pneumatic caps 162a, 164a, and 166a (which detect deviations in these pressure spikes in the event of a leak or misalignment of the membranes 190, 192).

[0141]

[0159] One or more membranes 190, 192 are placed under positive air pressure at the pneumatic cap 162a and seal against the inlet fluid valve chamber 182a to close the inlet valve. One or more membranes 190, 192 are placed under negative air pressure at the pneumatic cap 162a or vented to atmosphere to open (or make releasable) the inlet fluid valve chamber 182a. One or more membranes 190, 192 are placed under positive air pressure at the pneumatic cap 164a and seal against the outlet fluid valve chamber 184a to close the outlet valve. One or more membranes 190, 192 are placed under negative air pressure at the pneumatic cap 164a or vented to atmosphere to open (or make releasable) the outlet fluid valve chamber 184a.

[0142]

[0160] One or more membranes 190, 192 are placed under positive air pressure at the pneumatic cap 166a and seal against the fluid pump chamber 186a, causing a delivery stroke (with the inlet valve chamber closed and the outlet valve chamber open). One or more membranes 190, 192 are placed under negative air pressure at the pneumatic cap 166a and open the fluid pump chamber 186a, causing a pumping stroke (with the inlet valve chamber open and the outlet valve chamber closed).

[0143]

[0161] Fluid manifold 200a of pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of medical fluid management assembly 110a includes a fluid path plate 202a that is heat sealed, acoustically sealed, or solvent bonded to a cover plate 220a. Plates 202a and 220a may each be constructed of a rigid, medically safe plastic such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like.

[0144]

[0162] Fluid path plate 202a includes or defines inlet fluid path 204a and outlet fluid path 206a. Fluid path plate 202a further defines inlet valve O-ring seat 208a that sealingly retains inlet valve O-ring 144. Fluid path plate 202a further defines outlet valve O-ring seat 210a that sealingly retains outlet valve O-ring 144. Any fluid path described herein, such as outlet fluid path 206a, can be mated with a one-way valve or check valve 212. Fluid flows from left to right in FIG. 3. One-way valve or check valve 212 prevents fluid from flowing back from right to left into fluid pump chamber 186a.

[0145]

[0163] In one embodiment, separate gaskets are not required to seal the inlet fluid path 204a or the outlet fluid path 206a because the cover plate 220a is permanently sealed to the fluid path plate 202a. The cover plate 220a may include ridges or reinforcements 222a that help hold and seal the check valve 212 in place. In the illustrated embodiment, the inlet fluid valve chamber 182a and the outlet fluid valve chamber 184a each define fluid ports that sealingly fit with respective O-rings 144 and are adjacent to the mating fluid paths (e.g., the inlet fluid path 204a and the outlet fluid path 206a) to provide a fluid-tight connection between the pump and valve engine 160a and the fluid manifold 200a.

[0146]

[0164] Fluid, such as water, liquid concentrate, dialysate, or blood, flows under negative pressure from inlet fluid pathway 204a into inlet valve chamber 182a, through first fluid conduit 188a into fluid pump chamber 186a, and under positive pressure from fluid pump chamber 186a through second fluid conduit 188a and outlet valve chamber 184a through inlet fluid pathway 206a to its desired destination. For fluid pumping that benefits from continuous or near-continuous flow, such as blood pump 30, water pump 44, and dialysate pumps 64 and 94, the structure described with reference to FIG. 3 is duplicated so that as one fluid pump chamber 186a fills with blood, water, or dialysate, the other fluid pump chamber 186a can discharge blood, water, or dialysate. For certain pumping applications, such as heparin pump 26, acid pump 54, and UF pump 104, continuous pumping is not required, and therefore a single structure, such as the single fluid pump chamber 186a of FIG. 3, is sufficient.

[0147]

[0165] 4, which is a cross-sectional view of pump sections 26, 30, 44, 54, 64, 94, and 104 of another embodiment of a medical fluid management assembly 110b of the present disclosure. The medical fluid management assembly 110b in the illustrated embodiment again includes three main components: a pneumatic manifold 120b, a pump and valve engine 160b, and a fluid manifold 200b.

[0148]

[0166] In one embodiment, pneumatic manifold 120b includes metal plates or pieces 122b, 124b, and 126b. Notably, metal plate or piece 126b is much larger than metal piece 126b of FIG. 3, eliminating the need for the upper half of pump-valve engine 160a of FIG. 3. Metal plates or pieces 122b, 124b, and 126b may again be machined aluminum, steel, stainless steel, and combinations thereof. When adjacent, metal plates or pieces 122b, 124b, and 126b may be removably bolted together using bolts and nuts and / or mating internal threads.

[0149]

[0167] Metal plate 126b defines pneumatic pumping grooves 132a that selectively convey positive or negative pressure (or vent to atmosphere) to the pneumatic pump chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal plate 126b also defines inlet valve grooves 134b that selectively convey positive or negative pressure (or vent to atmosphere) to the inlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal plate 126b further defines outlet valve grooves 136b that selectively convey positive or negative pressure (or vent to atmosphere) to the outlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104.

[0150]

[0168] Pneumatic manifold 120b eliminates the need for upper O-ring seat and associated O-ring 144. Similar to FIG. 3, gasket 146b is compressed between metal plate 122b and metal plate 126b to seal pneumatic grooves or passages (e.g., groove or passage 134b) formed in metal plate 122b and / or metal plate 126b. Gasket 148b is compressed between metal plate 130b and metal plate 126b to seal pneumatic grooves or passages (e.g., groove or passage 132b) formed in metal plate 130b and / or metal plate 126b. Gasket 150b is compressed between metal plate 124b and metal plate 126b to seal pneumatic grooves or passages (e.g., groove or passage 136b) formed in metal plate 124b and / or metal plate 126b. Gaskets 146b, 148b, and 150b may again be, for example, compressible silicone. The pneumatic grooves or passages lead to electrically actuated pneumatic solenoid valves (as described above in FIG. 3) that may be spring-loaded closed when de-energized and open when energized.

[0151]

[0169] The pump and valve engine 160b of pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of medical fluid management assembly 110b eliminates the need for pneumatic caps 162a, 164a, and 166a, but still provides fluid strip 180b, which may again be constructed of a rigid, medically safe plastic such as polyethylene (“PE”), polypropylene (“PP”), polyvinyl chloride (“PVC”), polysulfone, polystyrene, polycarbonate (“PC”), acrylic, cycloolefin copolymer (“COC”), acrylonitrile butadiene styrene (“ABS”), polyolefin, or the like.

[0152]

[0170] 3 are replaced by inlet pneumatic valve chamber 136b, outlet pneumatic valve chamber 138b, and pneumatic pump chamber 140b, respectively, of pump sections 26, 30, 44, 54, 64, 94, and 104 of medical fluid management assembly 110b. Advantageously, the need for O-ring 144 sealing is eliminated.

[0153]

[0171] In the illustrated embodiment, fluid piece 180b is the same as fluid piece 180a of FIG. 3 (including all alternatives) and provides mating fluid chambers 182b, 184b, and 186b. Inlet fluid valve chamber 182b mates with inlet pneumatic valve chamber 136b. Outlet fluid valve chamber 184b mates with outlet pneumatic valve chamber 138b. Fluid pump chamber 186a mates with pneumatic pump chamber 140b. Inlet fluid valve chamber 182b, outlet fluid valve chamber 184b, and fluid pump chamber 186b each define fluid ports as shown that sealingly mate with respective O-rings 144 and are adjacent to mating fluid paths of fluid manifold 200b, providing a fluid-tight connection between pump and valve engine 160b and fluid manifold 200b.

[0154]

[0172] Similar to the above, fluid piece 180b is formed with fluid conduit portions 188b, i.e., a first fluid conduit portion 188b connecting inlet fluid valve chamber 182b and fluid pump chamber 186b, and a second fluid conduit portion 188b connecting fluid pump chamber 186b and outlet fluid valve chamber 184b. In one embodiment, inlet fluid valve chamber 182b, outlet fluid valve chamber 184b, fluid pump chamber 186b, and fluid conduit portion 188b are molded as a unitary structure and sized as needed. Again, it should be appreciated that while the pump and valve chambers are shown as spherical for ease of illustration, any or all of the pump and valve chambers could have alternative shapes, such as elliptical or oval.

[0155]

[0173] One or more flexible membranes or sheets 190, 192 are positioned between pneumatic chambers 136b, 138b, and 140b and fluid strip 180b. Membranes or sheets 190, 192 may be constructed of, for example, polyvinyl chloride ("PVC"), polyethylene, Kraton, or polyolefin, or another medically safe flexible plastic or rubber, and may have any of the alternatives described above in FIG. 3. Again, leaking fluid may be prevented from entering pneumatic manifold 120b through the use of any one or more of: (i) pressure testing; (ii) electrical contact sensors; (ii) capacitive or inductive sensors; or (iii) a memory containing known pressure spikes that would occur in the case of non-leaking membranes 190, 192. Pneumatic pumping operates in the same manner as in FIG. 3.

[0156]

[0174] The fluid manifold 200b of the pump sections 26, 30, 44, 54, 64, 94, and 104 of one embodiment of the medical fluid management assembly 110b is the same as described above (including all alternatives) and includes a fluid path plate 202b that is heat sealed, acoustically sealed, or solvent bonded to a cover plate 220b. Plates 202b and 220b may each be constructed of a rigid, medically safe plastic such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like.

[0157]

[0175] Fluid path plate 202b includes or defines inlet fluid path 204b and outlet fluid path 206b. Fluid path plate 202b further defines inlet valve O-ring seat 208b that sealingly retains inlet valve O-ring 144. Fluid path plate 202b further defines outlet valve O-ring seat 210b that sealingly retains outlet valve O-ring 144. Again, any of the fluid paths described herein can be mated with a one-way valve or check valve 212.

[0158]

[0176] In one embodiment, a separate gasket is not required because the cover plate 220b is permanently sealed to the fluid path plate 202b. The cover plate 220b may again include ridges or reinforcements 222b that help hold and seal the check valve 212 in place. The inlet fluid valve chamber 182b and the outlet fluid valve chamber 184b may again each define pneumatic ports that sealingly fit with respective O-rings 144 and adjacent the mating fluid paths to provide a fluid-tight connection between the pump and valve engine 160a and the fluid manifold 200a.

[0159]

[0177] Again, for fluid pumping that benefits from continuous or near-continuous flow, such as blood pump 30, water pump 44, and dialysate pumps 64 and 94, the structure described with respect to Figure 4 is duplicated so that as one fluid pump chamber 186b fills with blood, water, or dialysate, the other fluid pump chamber 186b can discharge blood, water, or dialysate. Certain pumping applications, such as heparin pump 26, acid pump 54, and UF pump 104, do not require continuous pumping, and therefore a structure such as the single fluid pump chamber 186b of Figure 4 is sufficient.

[0160]

[0178] 5, which is a cross-sectional view of pump sections 26, 30, 44, 54, 64, 94, and 104 of another embodiment of a medical fluid management assembly 110c of the present disclosure. In the illustrated embodiment, the medical fluid management assembly 110c includes two major components: a pneumatic manifold 120c and a fluid manifold 200c. A pump and valve engine is eliminated.

[0161]

[0179] 4 (including all alternatives) and includes metal plates or pieces 122c, 124c, and 126c, which again may be machined aluminum, steel, stainless steel, and combinations thereof. When adjacent, metal plates or pieces 122c, 124c, and 126c may be removably bolted together using bolts and nuts and / or mating internal threads.

[0162]

[0180] Metal plate 126c defines pneumatic pumping groove 132c that selectively conveys positive or negative pressure (or vents to atmosphere) to the pneumatic pump chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal plate 126c also defines inlet valve groove 134c that selectively conveys positive or negative pressure (or vents to atmosphere) to the inlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104. Metal plate 126c further defines outlet valve groove 136b that selectively conveys positive or negative pressure (or vents to atmosphere) to the outlet pneumatic valve chambers of pumps 26, 30, 44, 54, 64, 94, and 104.

[0163]

[0181] A gasket 146c is compressed between metal plates 122c and 126c to seal pneumatic grooves or passages (e.g., groove or passage 134c) formed in metal plates 122c and / or 126c. A gasket 148c is compressed between metal plates 130c and 126c to seal pneumatic grooves or passages (e.g., groove or passage 132c) formed in metal plates 130c and / or 126c. A gasket 150c is compressed between metal plates 124c and 126c to seal pneumatic grooves or passages (e.g., groove or passage 135c) formed in metal plates 124c and / or 126c. Gaskets 146c, 148c, and 150c may again be, for example, compressible silicone. The pneumatic groove or passage leads to an electrically actuated pneumatic solenoid valve (as described above in FIG. 3) which may be spring-loaded closed when de-energized and open when energized.

[0164]

[0182] Pump and valve engines 160a and 160b are completely eliminated. Again, pneumatic caps 162a, 164a, and 166a of FIG. 3 are replaced by inlet pneumatic valve chamber 136c, outlet pneumatic valve chamber 138c, and pneumatic pump chamber 140c of pneumatic manifold 120c, respectively, eliminating the need for O-ring 144 for sealing the airtight connections. In FIG. 5, fluid piece 180b of FIG. 4 is also completely eliminated.

[0165]

[0183] Inlet fluid valve chamber 182b of Figure 4 is replaced by inlet fluid valve chamber 224c of fluid manifold 200c, which mates with inlet pneumatic valve chamber 136b. Outlet fluid valve chamber 184b of Figure 4 is replaced by outlet fluid valve chamber 226c of fluid manifold 200c, which mates with outlet pneumatic valve chamber 138b. Fluid pump chamber 186a of Figure 4 is replaced by fluid pump chamber 228c of fluid manifold 200c. Inlet fluid valve chamber 224c, outlet fluid valve chamber 226c, and fluid pump chamber 228c, as shown, are each formed in fluid path plate 202b, eliminating the need for separate fluid ports, O-ring seats, and O-rings 144 in fluid manifold 200c.

[0166]

[0184] Fluid path plate 202b defines fluid conduit sections 230c, namely, a first fluid conduit section 230c connecting inlet fluid valve chamber 224c and fluid pump chamber 228c, and a second fluid conduit section 230c connecting fluid pump chamber 228c and outlet fluid valve chamber 226c. In one embodiment, inlet fluid valve chamber 224c, outlet fluid valve chamber 226c, fluid pump chamber 228c, and fluid conduit section 230c are molded as a unitary structure and sized as needed. Again, it should be appreciated that while the pump and valve chambers are shown as spherical for ease of illustration, any or all of the pump and valve chambers could have alternative shapes, such as elliptical or oval.

[0167]

[0185] One or more flexible membranes or sheets 190, 192 are positioned between pneumatic chambers 136c, 138c, and 140c and fluid chambers 224c, 226c, and 228c, respectively. Membranes or sheets 190, 192 may again be constructed of, for example, polyvinyl chloride ("PVC"), polyethylene, Kraton, or polyolefin, or another medically safe flexible plastic or rubber, and may have any of the alternatives described above in FIG. 3. Additionally, leaking fluid may again be prevented from entering pneumatic manifold 120b through the use of any one or more of: (i) pressure testing; (ii) electrical contact sensors; (ii) capacitive or inductive sensors; or (iii) a memory containing known pressure spikes that would occur in the case of non-leaking membranes 190, 192. Pneumatic pumping operates in the same manner as in FIG. 3.

[0168]

[0186] Fluid manifold 200c includes a cover plate 220c that is heat sealed, acoustically sealed, or solvent bonded to fluid path plate 202c, eliminating the need for a separate gasket. Plates 202c and 220c may each be constructed of a rigid, medically safe plastic, such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), or polyolefin. Fluid path plate 202c includes or defines inlet fluid pathway 204c leading to inlet fluid valve chamber 224c and outlet fluid pathway 206c leading from outlet fluid valve chamber 226c. Again, any of the fluid pathways described herein can be mated with one-way valves or check valves 212. The cover plate 220c may again include ridges or reinforcements 222c that help hold and seal the check valve 212 in place.

[0169]

[0187] Again, for fluid pumping that benefits from continuous or near-continuous flow, such as blood pump 30, water pump 44, and dialysate pumps 64 and 94, the structure described with respect to Figure 5 is duplicated so that as one fluid pump chamber 228c fills with blood, water, or dialysate, the other fluid pump chamber 228c can discharge blood, water, or dialysate. Certain pumping applications, such as heparin pump 26, acid pump 54, and UF pump 104, do not require continuous pumping, and therefore a structure such as the single fluid pump chamber 228c of Figure 5 is sufficient.

[0170]

[0188] 6, which is a cross-sectional view of one embodiment of a balance chamber portion 86a, 86b that may be included with any of the fluid management assemblies 110a-110c described above. In the illustrated embodiment, the balance chamber portion 86a, 86b of FIG. 6 includes three main components: a pneumatic manifold 240a, a valve engine 260a, and a fluid manifold 300a.

[0171]

[0189] In one embodiment, pneumatic manifold 240a includes metal plates or pieces 242a, 244a, and 246a, which may be machined aluminum, steel, stainless steel, and combinations thereof. When adjacent, metal plates or pieces 242a, 244a, and 246a may be removably bolted together using bolts and nuts and / or mating internal threads.

[0172]

[0190] Metal plate 242a defines pneumatic valve grooves 248a that selectively deliver positive or negative pressure (or vent to atmosphere) to the pneumatic valve chambers of valve engines 260a of balance chambers 86a, 86b. Metal plate 244a defines pneumatic valve grooves 250a that selectively deliver positive or negative pressure (or vent to atmosphere) to the pneumatic valve chambers of valve engines 260a of balance chambers 86a, 86b. There is no pneumatic connection to upper balance chambers 290a of balance chambers 86a, 86b. Upper balance chamber 290a is for delivering liquid.

[0173]

[0191] Metal plate 242a defines a valve O-ring seat 252a that sealingly retains valve O-ring 144. Metal plate 244a defines a valve O-ring seat 254a that sealingly retains outlet valve O-ring 144.

[0174]

[0192] A gasket 256a is compressed between metal plates 242a and 246a to seal pneumatic grooves or passages (e.g., groove or passage 248a) formed in metal plates 242a and / or 246a. A gasket 258a is compressed between metal plates 244a and 246a to seal pneumatic grooves or passages (e.g., groove or passage 250a) formed in metal plates 244a and / or 246a. Gaskets 256a and 258a may be made of, for example, compressible silicone. The pneumatic grooves or passages lead to the aforementioned electrically actuated pneumatic solenoid valves (not shown), which may be spring-loaded closed when de-energized and open when energized. The electrically actuated pneumatic solenoid valves may be attached to pneumatic manifold 240a.

[0175]

[0193] Valve engine 260a of balance chamber portion 86a, 86b of medical fluid management assembly 110a, 110b, or 110c includes pneumatic caps 262a and 264a and fluidic piece 280a. Caps 262a, 264a and fluidic piece 280a may each be constructed from a rigid, medically safe plastic such as polyethylene (“PE”), polypropylene (“PP”), polyvinyl chloride (“PVC”), polysulfone, polystyrene, polycarbonate (“PC”), acrylic, cycloolefin copolymer (“COC”), acrylonitrile butadiene styrene (“ABS”), polyolefin, or the like.

[0176]

[0194] Pneumatic caps 262a and 264a constitute the first and second pneumatic valve chambers of pump portion balance chambers 86a, 86b. Pneumatic caps 262a and 264a each sealingly fit over a respective O-ring 144 and adjacent mating grooves or passages (e.g., grooves 248a and 250a) to define pneumatic ports as shown that provide an airtight connection between valve engine 260a and pneumatic manifold 240a.

[0177]

[0195] In the illustrated embodiment, fluid piece 280a provides mating fluid chambers 282a, 284a, and 286a. Fluid valve chamber 282a mates with pneumatic valve cap 262a. Fluid valve chamber 284a mates with pneumatic valve cap 264a. Fluid balance chamber 286a mates with second fluid balance chamber 290 of second fluid piece 280a, shown in FIG. 6, positioned behind fluid piece 280a. Fluid valve chamber 282a and fluid valve chamber 284a each define fluid ports as shown that sealingly mate with respective O-rings 144 and are adjacent to mating fluid paths of fluid manifold 300a, providing a fluid-tight connection between valve engine 260a and fluid manifold 300a.

[0178]

[0196] In the illustrated embodiment, fluid piece 280a is formed with two fluid conduit sections 288a: a first fluid conduit section 288a connecting fluid valve chamber 282a and lower fluid balance chamber 286a, and a second fluid conduit section 288a connecting lower fluid balance chamber 286a and fluid valve chamber 284a. Also, second fluid piece 280a, shown in FIG. 6 and positioned behind fluid piece 280a, includes two fluid conduit sections 288a: a first fluid conduit section 288a connecting fluid valve chamber 282a (not visible in FIG. 6) and upper fluid balance chamber 290a, and a second fluid conduit section 288a connecting upper fluid balance chamber 290a and fluid valve chamber 284a (not visible in FIG. 6).

[0179]

[0197] 6 are formed as separate fluid pieces such that the fully visible fluid piece 280a (with the lower fluid balance chamber 286a) may be inserted into the fluid manifold 300a before the partially hidden fluid piece 280a (with the upper fluid balance chamber 290a) is inserted into the fluid manifold 300a, so that the upper fluid balance chamber 290a engages the lower fluid balance chamber 286a. In one embodiment, the fluid valve chamber 282a, the fluid valve chamber 284a, the fluid balance chamber 286a or 290a, and the fluid conduit portion 188a are molded as a unitary structure that makes up the fluid piece 280a.

[0180]

[0198] In an alternative embodiment, the first and second fluid pieces 280a of Figure 6 are formed or molded as a single piece, where the upper fluid balance chamber 290a is permanently sealed (e.g., sonic welded, heat sealed, or solvent bonded) to the lower fluid balance chamber 286a, capturing the flexible membranes 190, 192 between the balance chambers. The balance chambers 286a, 290a, with their associated four valves (two visible and two hidden in Figure 6), are then sealingly inserted together into the O-ring 144 of the fluid manifold 300a.

[0181]

[0199] Again, it will be appreciated that although the balance and valve chambers are shown as being spherical for ease of illustration, any or all of the balance and valve chambers could have alternative shapes such as elliptical or oval.

[0182]

[0200] One or more flexible membranes or sheets 190, 192 are positioned between the pneumatic caps 262a, 264a and the upper fluid balance chamber 290a and each chamber of the fluidic strip 280a. The membranes or sheets 190, 192 may be composed of, for example, polyvinyl chloride ("PVC"), polyethylene, Kraton, or polyolefin, or another medically safe, flexible plastic or rubber. The membranes or sheets 190, 192 may be flat and stretch upon actuation, or may have the same or similar shape as the pneumatic caps 262a, 264a and / or fluid valve chambers 282a, 284a, with a preform or pre-dome so that they flap back and forth instead of stretching. In one embodiment, the membranes or sheets 190, 192 for the balance chambers 286a, 290a are flat.

[0183]

[0201] Again, leaking fluid may be prevented from entering the pneumatic manifold 240a through the use of one or more of: (i) pressure testing, (ii) electrical contact sensors, (ii) capacitive or inductive sensors, or (iii) a memory containing known pressure spikes that would occur with non-leaking membranes 190, 192. The pneumatic actuation of the valves operates in the same manner as in FIG.

[0184]

[0202] Fluid manifold 300a of balance chamber portion 86a, 86b of medical fluid management assembly 110a, 110b, or 110c includes a fluid path plate 302a that is heat sealed, acoustically sealed, or solvent bonded to a cover plate 320a. Plates 302a and 320a may each be constructed of a rigid, medically safe plastic such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like.

[0185]

[0203] The fluid path plate 302a includes or defines a first fluid path 304a and a second fluid path 306a. The fluid path plate 302a further defines a first valve O-ring seat 308a that sealingly retains the first valve O-ring 144. The fluid path plate 302a further defines a second valve O-ring seat 310a that sealingly retains the second valve O-ring 144. Any of the fluid paths described herein, such as the outlet fluid path 306a, can be mated with a one-way valve or check valve 212.

[0186]

[0204] In one embodiment, separate gaskets are not required to seal the first fluid path 304a or the second fluid path 306a because the cover plate 320a is permanently sealed to the fluid path plate 302a. The cover plate 320a may include ridges or reinforcements 322a that help hold and seal the check valve 212 in place. In the illustrated embodiment, the first fluid valve chamber 282a and the second fluid valve chamber 284a each define fluid ports that sealingly fit with respective O-rings 144 and are adjacent to the mating fluid paths (e.g., the first fluid path 304a and the second fluid path 306a) to provide a fluid-tight connection between the valve engine 260a and the fluid manifold 300a.

[0187]

[0205] Fluids, such as water, liquid concentrate, dialysate, or blood, flow through balance chambers 86a, 86b as follows: As mentioned above, balance chambers 286a and 290a, separated by membranes 190, 192, are associated with four valves (the left and right valves seen in FIG. 6 and the left and right valves behind the valves seen in FIG. 6). One of the visible left and right valves is the inlet valve to the lower balance chamber 286a, and the other of the visible left and right valves is the outlet valve to the lower balance chamber 286a. The same applies to the hidden valves, but this is the case for the upper balance chamber 290a. One of the hidden left and right valves is the inlet valve to the upper balance chamber 290a, and the other of the hidden left and right valves is the outlet valve to the upper balance chamber 290a. Depending on the position of the parallel chambers 86a, 86b relative to the other components of the medical fluid management assembly 110a, 110b, or 110c, it may be more convenient to (i) have both left-side valves be inlet valves and both right-side valves be outlet valves, (ii) have both left-side valves be outlet valves and both right-side valves be inlet valves, (iii) have the left-side visible valve be an inlet valve, the right-side visible valve be an outlet valve, the left-side hidden valve be an outlet valve, and the right-side hidden valve be an inlet valve, or (iv) have the left-side visible valve be an outlet valve, the right-side visible valve be an inlet valve, the left-side hidden valve be an inlet valve, and the right-side hidden valve be an outlet valve.

[0188]

[0206] Referring now to Figure 7, this figure is a cross-sectional view of another embodiment of a balance chamber portion 86a, 86b that may be included with any of the fluid management assemblies 110a-110c described above. In the embodiment shown, the balance chamber portion 86a, 86b of Figure 7 includes two main components: a pneumatic manifold 240b and a fluid manifold 300b. The valve engine 260a of Figure 6 is eliminated.

[0189]

[0207] In one embodiment, pneumatic manifold 240b includes metal plates or pieces 242b, 244b, and 246b, which may be machined aluminum, steel, stainless steel, and combinations thereof. When adjacent, metal plates or pieces 242b, 244b, and 246b may be removably bolted together using bolts and nuts and / or mating internal threads.

[0190]

[0208] Metal plate 242b defines a pneumatic valve groove 248b that selectively delivers positive or negative pressure (or vents to atmosphere) to a first pneumatic valve chamber 245b defined by metal plate 242b. Metal plate 244b defines a pneumatic valve groove 250b that selectively delivers positive or negative pressure (or vents to atmosphere) to a second pneumatic valve chamber 247b defined by metal plate 244b. Again, there is no pneumatic connection to an upper balance chamber 290b of balance chambers 86a, 86b. Upper chamber 290b is for delivering liquid.

[0191]

[0209] All pneumatic O-ring seats and associated O-rings 144 of FIG. 6 are eliminated.

[0192]

[0210] A gasket 256b is compressed between metal plates 242b and 246b to seal pneumatic grooves or passages (e.g., groove or passage 248b) formed in metal plates 242b and / or 246b. A gasket 258b is compressed between metal plates 244b and 246b to seal pneumatic grooves or passages (e.g., groove or passage 250b) formed in metal plates 244b and / or 246b. Gaskets 256b and 258b may be made of, for example, compressible silicone. The pneumatic grooves or passages lead to the aforementioned electrically actuated pneumatic solenoid valves (not shown), which may be spring-loaded closed when de-energized and open when energized. The electrically actuated pneumatic solenoid valves may be attached to pneumatic manifold 240b.

[0193]

[0211] Fluid manifold 300b of balance chamber portion 86a, 86b of medical fluid management assembly 110a, 110b, or 110c includes a fluid path plate 302b that is heat sealed, acoustically sealed, or solvent bonded to a cover plate 320b. Plates 302b and 320b may each be constructed of a rigid, medically safe plastic such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like.

[0194]

[0212] The fluid path plate 302b includes or defines a first fluid path 304b and a second fluid path 306b. The fluid valve O-ring seat and associated O-ring 144 of FIG. 6 are eliminated. Any of the fluid paths described herein, such as the outlet fluid path 306a, can be mated with a one-way valve or check valve 212. In one embodiment, a separate gasket is not required to seal the first fluid path 304b or the second fluid path 306b because the cover plate 320b is permanently sealed to the fluid path plate 302b. The cover plate 320b may include ridges or reinforcements 322b that help hold and seal the check valve 212 in place.

[0195]

[0213] In the illustrated embodiment, the fluid path plate 302b defines a first fluid valve chamber 312b and a second fluid valve chamber 314b. The first fluid valve chamber 312b mates with the first pneumatic valve chamber 245b. The second fluid valve chamber 314b mates with the second pneumatic valve chamber 247b. The first fluid valve chamber 312b is in fluid communication with the lower balance chamber 316b via a first fluid conduit portion 318b. Meanwhile, the second fluid valve chamber 314b is in fluid communication with the lower balance chamber 316b via a second fluid conduit portion 318b. In the illustrated embodiment, the lower balance chamber 316b and the first and second fluid conduit portions 318b are each formed by or in the fluid path plate 302b.

[0196]

[0214] The first and second hidden fluid valve chambers are positioned behind the first and second visible chambers 312b and 314b. The first hidden fluid valve chamber is in fluid communication with the upper balance chamber 319b via a third fluid conduit section 318b, while the second hidden fluid valve chamber is in fluid communication with the upper balance chamber 319b via a fourth fluid conduit section 318b. In one embodiment, the third and fourth fluid conduit sections 318b are heat sealed, sonic welded, or solvent bonded to the fluid path plate 302b and the upper balance chamber 319b, respectively, and then heat sealed, sonic welded, or solvent bonded to the lower balance chamber 316b. In an alternative embodiment, the third and fourth fluid conduit sections 318b are sealingly pressed into O-rings 144 (not shown) fitted to the fluid path plate 302b, so that the upper balance chamber 319b (permanently welded, heat sealed, or attached to the third and fourth fluid conduit sections 318b) is sealingly pressed onto the lower balance chamber 316b and held in place by the plate 246b.

[0197]

[0215] Again, it will be appreciated that although the balance and valve chambers are shown as being spherical for ease of illustration, any or all of the balance and valve chambers could have alternative shapes such as elliptical or oval.

[0198]

[0216] One or more flexible membranes or sheets 190, 192 are positioned between the pneumatic valve chambers 245b, 247b and the upper fluid balance chamber 319b and the respective chambers 312b, 314b, and 316b of the fluid path plate 302b. The membranes or sheets 190, 192 may be composed of, for example, polyvinyl chloride ("PVC"), polyethylene, Kraton, or polyolefin, or another medically safe, flexible plastic or rubber. The membranes or sheets 190, 192 may be flat and stretch upon actuation, or may have the same or similar shape as the pneumatic valve chambers 245b, 247b and / or fluid valve chambers 312a, 314a, with a preform or pre-dome so that they flap back and forth instead of stretching. In one embodiment, the membranes or sheets 190, 192 for the balance chambers 316b, 319b are flat, but may alternatively be pre-domes or pre-forms.

[0199]

[0217] Again, leaking fluid may be prevented from entering the pneumatic manifold 240b through the use of one or more of: (i) pressure testing, (ii) electrical contact sensors, (ii) capacitive or inductive sensors, or (iii) a memory containing known pressure spikes that would occur with non-leaking membranes 190, 192. The pneumatic actuation of the valves operates in the same manner as in FIG.

[0200]

[0218] Fluid, such as water, liquid concentrate, dialysate, or blood, flows through balance chambers 86a and 86b as described above with respect to Figure 6, except that balance chambers 316b and 319b in Figure 7 replace balance chambers 286a and 290a, respectively, in Figure 6.

[0201]

[0219] 8, which is a cross-sectional view of one embodiment of a water accumulator 42 that may be included with any of the fluid management assemblies 110a-110c described above. In the embodiment shown, the water accumulator 42 of FIG. 8 includes only a fluid manifold 330. The fluid manifold 330 includes a fluid path plate 332 sealed to a cover plate 340. The fluid path plate 332 defines an inlet water path 334 leading to a water chamber 336 and an outlet water path 338 leading from the water chamber 336. The water chamber 336 is permanently sealed or sealed by an air chamber plate 342.

[0202]

[0220] The fluid path plate 332, cover plate 340, and air chamber plate 342 may each be constructed from a rigid, medically safe plastic, such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, or the like. The fluid path plate 332 may be heat sealed, acoustically sealed, or solvent bonded to both the cover plate 340 and the air chamber plate 342. Alternatively, the air chamber plate 342 may be held in compression over the water chamber 336. In either case, pressure is applied to one or more flexible membranes 190, 192 between the water chamber 336 and the air chamber plate 342.

[0203]

[0221] The flexible membranes 190, 192 may be constructed from any of the materials described above and can stretch to increase or decrease the amount of water entering the water chamber 336. The flexible membranes 190, 192 also tend to dampen pulsations in the water flow to the mixing section of the device 90.

[0204]

[0222] 9, which is a cross-sectional view of one embodiment of a mixing chamber 52 that may be included with any of the fluid management assemblies 110a-110c described above. In the embodiment shown, the mixing chamber portion 52 of FIG. 9 includes only a fluid manifold 350. The fluid manifold 350 includes a fluid path plate 352 that is sealed to a cover plate 370 in any manner described above. The fluid path plate 352 defines an inlet water / bicarbonate mixing pathway 354 and an inlet liquid acid pathway 356 that lead to a mixing chamber housing 358, and an outlet mixed dialysate pathway 360 that leads from the mixing chamber housing 358 to a desired destination.

[0205]

[0223] The fluid path plate 352 and cover plate 360 ​​may each be constructed from a rigid, medically safe plastic such as polyethylene ("PE"), polypropylene ("PP"), polyvinyl chloride ("PVC"), polysulfone, polystyrene, polycarbonate ("PC"), acrylic, cycloolefin copolymer ("COC"), acrylonitrile butadiene styrene ("ABS"), polyolefin, etc. The fluid path plate 352 may be heat sealed, acoustically sealed, or solvent bonded to the cover plate 360. In this case, flexible membranes 190, 192 are not used.

[0206]

[0224] The mixing chamber allows water premixed with bicarbonate (eg, dry bicarbonate powder) to mix with metered liquid acid to produce fresh dialysate for use in the device 90 .

[0207]

[0225] Referring now to FIG. 10, this figure illustrates one embodiment in which a conductivity sensor 36 is incorporated into a medical fluid management assembly of the present disclosure. The conductivity sensor 36 is additionally illustrated with respect to FIG. 12 below. The conductivity sensor 36 is illustrated as incorporated into the fluid management assembly 110c of FIG. 5. Each of the element numbers illustrated in FIG. 10 are also illustrated in FIG. 5, but include all structures, functions, and alternatives described above with respect to FIG. 5 or incorporated by reference thereto. Similarly, it will be appreciated that the conductivity sensor 36 may be incorporated into the fluid management assemblies 110a and 110b of FIGS. 3 and 4, respectively, in the manner described above with respect to FIG. 10.

[0208]

[0226] FIG. 10 shows that fluid pathway 206c leads to inlet or outlet port 214c, which in the illustrated embodiment is sealingly connected to tubing by a hose barb connection. Looking at FIG. 12 and the exemplary placement of conductivity sensor 36, the tubing may be, for example, purified water line 62, tubing from acid pump 74, or tubing leading to or from water pump 52. In the illustrated embodiment, conductivity sensor 36 is located in outlet fluid pathway 206c between outlet pneumatic valve chamber 138c / outlet fluid valve chamber 226c and inlet or outlet port 214c. In alternative embodiments, conductivity sensor 36 is positioned upstream of inlet port 214c or downstream of outlet port 214c.

[0209]

[0227] In the illustrated embodiment, the conductivity sensor 36 includes an insert 36a (e.g., some kind of cone or cone-shaped insert) disposed in sealing engagement with the fluid path plate 202c by a compression O-ring 216c. Alternatively, the insert 36a may be molded into the plate 202c. In one embodiment, the insert 36a is discarded when the manifold 200c is discarded, which may be after one use or multiple uses (e.g., one month's worth of use). The insert 36a is constructed of a medically safe conductive material, such as stainless steel or titanium.

[0210]

[0228] Alternatively, a metal plate or piece 126c of the pneumatic manifold 120c carries a conductivity probe 36b. The probe 36b is similarly constructed of a conductive material, such as copper, steel, aluminum, or stainless steel. The probe 36b is not intended to come into contact with medical fluids or any of the fluids described herein. The probe 36b includes a conical or cone-shaped insert end 36c that contacts and mates with the insert 36a. The conductivity probe 36b includes a threaded end 36d that screws into a mating threaded hole in the metal plate or piece 126c of the pneumatic manifold 120c. A sensing lead 36e leads from the threaded end 36d to the control unit 50 (FIG. 1). The probe 36b is reusable as long as it functions properly. Therefore, only the small, thin conductivity probe 36a needs to be disposed of, even after multiple uses. Therefore, the conductivity sensor 36 of the present disclosure does not significantly increase disposal costs.

[0211]

[0229] The conductivity of the fluid passing through the fluid path 206c can be detected by the insert 36a in contact with a conductive probe rod 36b having conductive leads extending to the control unit 50. In one embodiment, each conductivity sensor 36 shown in FIG. 12 is actually a sensor pair (e.g., two of the sensors 36 shown in FIG. 10). One sensor of the pair further includes a thermistor or thermocouple wire compressed between the mating conductive insert 36a and the conductivity probe 36b to sense the fluid temperature at the point where the conductivity measurement is taken. In this manner, the control unit 50 may provide a temperature-compensated conductivity measurement by inputting the associated fluid temperature.

[0212]

[0230] Figure 10 also illustrates an embodiment in which pneumatic manifold 120c and fluid manifold 200c are secured together to apply pressure to gaskets 146c, 148c, 150c and flexible membranes 190 and 192 to provide air-tight and liquid-tight fluid management assembly 110c. Also, in the embodiment discussed with respect to Figure 10, gasket 144 shown in Figures 3 and 4 is compressed to provide air-tight and liquid-tight fluid management assemblies 110a and 110b.

[0213]

[0231] In the illustrated embodiment, pneumatic manifold 120c may be constructed from various metal plates or pieces and may be threaded. FIG. 10 shows that metal plate or piece 124c defines a through-hole that allows threads from bolt or fastener 390 to pass through metal plate or piece 124c and into mating female threads in threaded hole 127c formed in plate 126c. Bolt or fastener 390 may be fastened with one or both flat lock washers 392. Multiple bolts or fasteners 390 may be provided as needed to compress gaskets 146c, 148c, and 150c to seal pneumatic passages, such as passage 135c shown in FIG. 10. Bolts or fasteners 390 need only be removed from pneumatic manifold 120c when maintenance is required, such as in the event of a fluid leak into a pneumatic passage, such as passage 135c. Pneumatic manifolds 120a and 120b of FIGS. 3 and 4, respectively, may be similarly held together using bolts or fasteners 390.

[0214]

[0232] In various embodiments, fluid manifolds 200a, 200b, and 200c of Figures 3, 4, 5, and 10, respectively, are held together by heat sealing, acoustic sealing, or solvent bonding. Sealing together (i) pump and valve engine 160a (pump and valve engine 160a to pneumatic manifold 120a and fluid manifold 200a) in Figure 3, (ii) pump and valve engine 160b (pump and valve engine 160b to fluid manifold 200b) in Figure 4, and (iii) pneumatic manifold 120c and fluid manifold 200c in Figures 5 and 10 is performed using long bolts or fasteners 394, as shown in Figure 10. Again, Figure 10 illustrates situation (iii) (sealing pneumatic manifold 120c to fluid manifold 200c).

[0215]

[0233] 10, plate 126c of pneumatic manifold 120c defines perforations or openings 142c, while fluid path plate 202c of fluid manifold 200c defines mating perforations or openings 218c. Mating perforations or openings 142c and 218c receive bolts or fasteners 394. In one embodiment, the exterior of fluid manifold 200c is provided with quick disconnects 396 (e.g., bicycle-style quick clamps) that a user can quickly release to pull fluid manifold 200c from pneumatic manifold 120c while bolted or otherwise connected to device 90. Quick disconnects 396 couple multiple fasteners 394 (including one or both of flat lock washers 392), allowing a user to quickly undo disconnect 396 and replace fluid manifold 200c as needed. In one embodiment, flexible membranes 190 and 192 are provided with fluid manifolds 200c such that new membranes are provided with new manifolds 200c. Fluid management assemblies 110a and 110b allow for replacement of pump and valve engines and fluid manifolds upon release of quick disconnect 396.

[0216]

[0234] Of course, other types of quick disconnects may be used, and alternatively, the quick disconnects may be replaced with nuts or lock nuts, and the user may replace the appropriate pump, valve engine, and / or fluid manifold by removing the nuts with a tool.

[0217]

[0235] Referring now to FIG. 11, this figure illustrates one embodiment of incorporating an electrically actuated pneumatic valve 400 into a medical fluid management assembly of the present disclosure. The electrically actuated pneumatic valve 400 is shown as incorporated into the fluid management assembly 110c of FIG. 5. Each of the element numbers shown in FIG. 11 is also shown in FIG. 5, but includes all structures, functions, and alternatives described above with respect to FIG. 5 or incorporated by reference thereto. Similarly, it will be appreciated that the electrically actuated pneumatic valve 400 may also be incorporated into the fluid management assemblies 110a and 110b of FIGS. 3 and 4, respectively, in the manner described above with respect to FIG. 11.

[0218]

[0236] Again, pneumatic passage 135c is provided to route positive or negative air pressure to pneumatic valve chamber 138c (inlet or outlet) in plate 126c. In FIG. 11, positive groove or passage 137c and negative groove or passage 139c have been added so that valve 400 can supply positive or negative air pressure to pneumatic passage 135c and pneumatic valve chamber 138c. Of course, negative groove or passage 139c could alternatively be a passage to atmosphere. That is, instead of using negative pressure to open flexible membranes 190 and 192, positive pressure could vent the membranes to atmosphere after closing, allowing positive fluid pressure on the other side of the membrane to open the valve. However, if groove or passage 139c is used for negative pressure, the passage would be pneumatically connected to a negative pressure source, such as a negative pressure container or manifold. Similarly, positive groove or passage 137c would be pneumatically connected to a positive pressure source, such as a positive pressure container or manifold.

[0219]

[0237] Electrically actuated pneumatic valve 400 may take different forms. In the case of a pneumatic valve chamber, such as pneumatic valve chamber 138c, pneumatic valve 400 may be an on / off type valve using an electrically actuated solenoid 412 to open or close pneumatic passage 135c and pneumatic valve chamber 138c to provide positive or negative pressure (or venting). In one embodiment, electrically actuated solenoid 412 is normally closed and requires electrical energy to open valve chamber 138c to provide positive or negative pressure. Thus, in the event of a power failure, no action occurs. As noted above, flexible membranes 190 and 192 may be preforms or predomes and may be positioned to close relative to fluid valve chamber 226c in the event of a power failure.

[0220]

[0238] In the case of a pneumatic pump chamber, such as pneumatic pump chamber 140c of Figure 5, pneumatic valve 400 may be a variable orifice valve commanded by control unit 50 (Figure 1) so that varying amounts of positive or negative air pressure can be delivered to pneumatic pump chamber 140c. Regardless of the type of valve 400 used, positive pressure in Figure 11 is supplied to pneumatic passage 135c and pneumatic valve chamber 138c through positive groove or passage 137c, positive valve inlet 408, and valve outlet 406. Similarly, regardless of the type of valve 400 used, negative pressure in Figure 11 is supplied to pneumatic passage 135c and pneumatic valve chamber 138c through negative groove or passage 139c, negative valve inlet passage 410, and valve outlet passage 406.

[0221]

[0239] FIG. 11 illustrates that the pneumatic valve 400 can be sealingly and directly mounted to a fluid management assembly of the present disclosure, such as the fluid management assembly 110c of FIGS. 5 and 11. As shown, this configuration allows the pneumatic passages (e.g., passage 135c) between the valve 400 and each pneumatic chamber (e.g., chamber 138c) to be as short as possible. The positive passage 137c and negative passage 139c may be manifold lines supplying multiple valves. In this manner, the pneumatic routing of the fluid management assembly of the present disclosure may be minimized.

[0222]

[0240] 12, which is an overall view of one embodiment of a fluid management assembly 110a (using a pump according to FIG. 3), 110b (using a pump according to FIG. 4), or 110c (using a pump according to FIG. 5), any of which employ a balance chamber according to FIG. 6 or 7, a water accumulator according to FIG. 8, and a mixing chamber according to FIG. 9. Fluid management assemblies 110a-110c include an overall fluid manifold 380, which may be considered a combination or fusion of the fluid manifolds 200a / 200b / 200c, 300a / 300b, 330, and 350 described above, along with the definition of other fluid paths discussed below.

[0223]

[0241] In one embodiment, in a water accumulator 42 provided in accordance with Figure 9, unused water is introduced by purified water line 62 into an overall fluid manifold 380. The purified water is pumped by a water pump 44 provided in accordance with any of Figures 3-5 to a bicarbonate cartridge 72 located within the apparatus 90 away from the fluid manifold 380. Simultaneously, a liquid acid pump 54 provided in accordance with any of Figures 3-5 pumps liquid acid concentrate from a container 74 located within the apparatus 90 away from the fluid manifold 380.

[0224]

[0242] 12 shows that the fluid manifold 380 provides space for the conductivity sensor 36 to measure the fluid conductivity at appropriate locations, such as in the water line 62, downstream of the bicarbonate cartridge 72, in the liquid acid line, and downstream of the mixing chamber 52, where the resulting fresh dialysate conductivity is within a set range. The conductivity sensor 36 is shown by dashed lines to communicate with the control unit 50 (FIG. 1). The control unit 50 relies on the signal from the conductivity probe to assess whether the dialysate has been properly mixed and ensure that the dialysate has been properly mixed.

[0225]

[0243] Fresh dialysate is pumped to a dialysate holding tank 53 located within the device 90 away from the fluid manifold 380. A fresh dialysate pump 64, provided in accordance with any of Figures 3-5, pumps the fresh dialysate from the holding tank 53 through an ultrafilter 78 attached to the fluid manifold 380 and disposed in fluid-tight communication with the fluid manifold 380. As shown, the ultrafilter 78 separately outputs purified dialysate to a heater 80 and rejects a portion of the dialysate that returns to the dialysate holding tank 53. The heater 80 is located within the device 90 away from the fluid manifold 380.

[0226]

[0244] The heated fresh dialysate is pumped by fresh dialysate pump 64 into parallel chambers 86a and 86b. Parallel chambers 86a and 86b may be provided in accordance with either of FIGS. 6 and 7. Spent dialysate is pumped into parallel chambers 86a and 86b from dialyzer 40 by spent dialysate pump 94. Dialysis device 40 is positioned within system 90 away from fluid manifold 380. Spent dialysate pump 94 may be provided in accordance with either of FIGS. 3-5. The spent dialysate entering parallel chambers 86a and 86b carries an equal volume of spent dialysate to dialyzer 40. The spent dialysate entering parallel chambers 86a and 86b carries an equal volume of spent dialysate to the drain via discharge line 82.

[0227]

[0245] A UF pump 104, configured according to any of FIGS. 3-5, meters a precise, predetermined amount of used dialysate as UF into the drain line 82. The drain line 82 extends to the drain cassette 102 and then from the drain cassette to an indoor drain. The drain cassette 82 is also fluidly connected to a blood tubing connector 103. The blood tubing connector 103 (which may be located at the front of the device 90 for easy user access) accepts the arterial and venous lines 14 and 16 that are not connected to the patient 12 (FIG. 1), allowing sterilization and priming to occur with the integrated connection of the dialysate and blood circuits. Because sterilizing and priming fluids contact the blood lines 14 and 16 that carry the patient's blood and can reach the drain cassette 102, the drain cassette is separate from the fluid manifold 380; therefore, when the device 90 is used with a different patient, only the small drain cassette 102 needs to be replaced, while the manifold 380 remains. For this reason, a check valve 212 is placed in the exhaust line 82 upstream of the exhaust cassette to prevent backflow of fluid from the exhaust cassette into the fluid manifold 380. As mentioned above, other check valves 212 may be incorporated into the overall fluid manifold 380.

[0228]

[0246] 12 also illustrates that fluid management assemblies 110a-110c may also include a blood pump 30 and a heparin pump 26 (each of which may be provided in accordance with any of FIGS. 3-5). Blood pump 30 draws blood from arterial line 14 when connected to patient 12, and pumps blood through dialyzer 40 and venous line 16 when connected to patient 12, as indicated by the arrows (blood indicated by dashed lines and dialysate indicated by solid lines). In one embodiment, heparin is pumped from vial 24 into arterial line 14 by the heparin pump as indicated by the arrows (heparin indicated by dashed and dotted lines).

[0229]

[0247] Thus, FIG. 12 illustrates that nearly all fluid-contacting components of device 90 can be located on a single fluid manifold 380. The only components depicted in FIG. 12 that reside outside the front of device 10 are dialysis machine 40, heparin vial 24, arterial line 14, venous line 16, and blood tubing connector 103, providing a sleek and simplified appearance for the device. Water line 62 and drain line 82 may extend from the rear of device 90. Also, in an alternative embodiment, blood pump 30 is visible from the front of device 90. While heparin vial 24 is replaced with a new vial after each treatment, blood set 100 is expected to be sterilized, reused, and replaced approximately once per month. Other components of fluid manifold 380 may be replaced approximately every few months (e.g., six months).

[0230]

[0248] Viewing FIG. 12 in light of FIGS. 3-9, it will be appreciated that the water pump 44, acid pump 54, fresh dialysate pump 64, parallel chambers 86a-86b, spent dialysate pump 94, UF pump 104, blood pump 30, and heparin pump 26 have pneumatic components corresponding to the fluid components of fluid manifold 380. The water accumulator 42, mixing chamber 52, and ultrafilter 78 do not have corresponding pneumatic components. Thus, in one embodiment, it is contemplated to provide the water accumulator 42, mixing chamber 52, and ultrafilter 78 in a fluid management assembly different from assemblies 110a-110c of FIG. 12, thereby allowing the pneumatics to operate efficiently only when the fluid management assembly requires pneumatic actuation. In alternative embodiments, different fluid management assemblies are differentiated based on their intended use (e.g., water mixing, dialysate pumping, or blood pumping). Alternatively or additionally, different fluid management assemblies are differentiated based on whether they include disposable or reusable components.

[0231]

[0249] The 12 fluid components of the fluid manifold 380 of Figure 12 are laid out in a linear or 12 x 1 array. In alternative embodiments, the 12 fluid components of the fluid manifold 380 of Figure 12 are still integrally disposed, but are laid out in a 6 x 2 array (split after the ultrafilter 78) or a 4 x 3 array (split after the mixing chamber 52 and parallel chambers 86a, 86b).

[0232]

[0250] In yet another alternative embodiment, the twelve fluid components of fluid manifold 380 of FIG. 12 may be physically separated from one another, e.g., according to function, such that separate manifolds and corresponding fluid management assemblies are located where desired within device 90. For example, a first water and mixed fluid management assembly including water accumulator 42, water pump 44, acid pump 54, and mixing chamber 52 may be located in a first location within device 90 (e.g., near bicarbonate cartridge 72 and acid container 74). A second dialysate management assembly including fresh dialysate pump 64, ultrafiltration device 78, parallel chambers 86a, 86b, spent dialysate pump 94, and UF pump 104 may be located in a second location within device 90 (e.g., near dialysate holding tank 53). A third blood fluid management assembly including a blood pump 30, a heparin pump 26, and a heparin vial 24 may be provided at a third location within the device 90 (e.g., near the dialysis machine 40 and / or the blood tubing connector 103).

[0233]

[0251] 13, which is a schematic cross-sectional view of the fluid management assembly 110a described above with respect to FIG. 3. The medical fluid management assembly 110a includes the pneumatic manifold 120a, the pump and valve engine 160a, and the fluid manifold 200a, as described above, including all structures, functions, and alternatives. In various embodiments, the pneumatic manifold 120a may be fixed to the housing of the device 90 (FIG. 1), while the pump and valve engine 160a and the fluid manifold 200a are removable from the pneumatic manifold 120a for periodic replacement. The pump and valve engine 160a and the fluid manifold 200a may be accessible from the front, rear, or one of the left and right sides of the device 90, for example.

[0234]

[0252] Referring now to FIG. 14, this figure schematically illustrates one embodiment of another alternative fluid management assembly 110d for operation in a renal failure therapy system, such as system 10 (FIG. 1). Here, dual fluid manifolds 200d1 and 200d2 are aligned back-to-back. The first fluid manifold 200d1 operates in conjunction with a first pneumatic manifold 120d1 and a first pump and valve engine 160d1 according to any of the present disclosures provided herein. Meanwhile, the second fluid manifold 200d2 operates in conjunction with a second pneumatic manifold 120d2 and a second pump and valve engine 160d2 according to any of the present disclosures provided herein. In an alternative embodiment, some or all of one or both of the first pump and valve engine 160d1 and the second pump and valve engine 160d2 are removed in accordance with FIGS. 4 and 5.

[0235]

[0253] The first pneumatic manifold 120d1 and the second pneumatic manifold 120d2 may be hingedly connected to the housing of the device 90 so that the respective pump-valve engines and fluid manifolds can be hinged away from each other and replaced. After replacement, the first pneumatic manifold 120d1 and the second pneumatic manifold 120d2 are hinged together. In the illustrated embodiment, the first pneumatic manifold 120d1 and the second pneumatic manifold 120d2 are operably connected to the control unit 50 for valve operation and sensor readout.

[0236]

[0254] In FIG. 14, a first fluid manifold 200d1 takes in water, acid, and bicarbonate and includes all of the components from the left end of FIG. 12 through the ultrafilter 78, thereby outputting purified dialysate to the dialyzer 40. A second fluid manifold 200d2 takes in spent dialysate from the dialyzer 40 and includes all of the components from the parallel chambers 86a, 86b through the UF pump 104, thereby outputting the spent dialysate to drain. Separate from the fluid management assembly 110d is the blood set 100 (FIG. 2), which pumps blood from the patient 12 through the dialyzer 40 under negative pressure along the arterial line 14 (in one embodiment, dialysate backflow) and returns blood to the patient 12 under positive pressure via the venous line 16.

[0237]

[0255] 15, the same fluid management assembly 110d (including all of the structures, features, and alternatives described in or incorporated above in FIG. 14) may be adapted for use in a different blood therapy (e.g., providing hemofiltration for sepsis). Again, a blood set 100 (FIG. 2) separate from the fluid management assembly 110d is provided, which pumps blood under negative pressure from the patient 12 along the arterial line 14 to the second fluid manifold 200d2, which pumps the blood through the sepsis filter 440 to the first fluid manifold 200d1, and returns the blood to the patient 12 under positive pressure via the venous line 16.

[0238]

[0256] Referring now to FIG. 16, this figure schematically illustrates one embodiment of yet another alternative fluid management assembly 110e for operation in a renal failure therapy system, such as system 10 (FIG. 1). Again, dual fluid manifolds 200e1 and 200e2 are aligned back-to-back. First fluid manifold 200e1 operates in conjunction with first pneumatic manifold 120e1 and first pump and valve engine 160e1 according to any of the present disclosures provided herein. Meanwhile, second fluid manifold 200e2 operates in conjunction with second pneumatic manifold 120e2 and second pump and valve engine 160e2 according to any of the present disclosures provided herein. In an alternative embodiment, some or all of one or both of first pump and valve engine 160e1 and second pump and valve engine 160e2 are removed in accordance with FIGS. 4 and 5.

[0239]

[0257] Again, first and second pneumatic manifolds 120e1 and 120e2 may be hingedly connected to the housing of device 90 for component replacement. In the illustrated embodiment, first and second pneumatic manifolds 120e1 and 120e2 are operably connected to control unit 50 for valve operation and sensor readout. In FIG. 16, first fluid manifold 200e1 receives water, acid, and bicarbonate and outputs purified dialysate to dialyzer 40 by including all components from the left end of FIG. 12 to ultrafilter 78. Second fluid manifold 200e2 receives spent dialysate from dialyzer 40 and includes all components from parallel chambers 86a, 86b to the right end of FIG. 12 (including blood pump 30 and heparin pump 24). Here, blood set 100 (FIG. 2) is incorporated into fluid management assembly 110e. The integrated blood pump 30 pumps blood from the patient 12 along the arterial line 14 through the dialyzer 40 under negative pressure (backflow of dialysate in one embodiment) and returns blood to the patient 12 via the venous line 16 under positive pressure.

[0240]

[0258] In one embodiment, first pneumatic manifold 120e1 and second pneumatic manifold 120e1 are mounted to the housing of device 90 (FIG. 1) so that they can slide apart from one another. First pneumatic manifold 120e1 includes first pump and valve engine 160e1 and first fluid manifold 200e1, while second pneumatic manifold 120e2 includes second pump and valve engine 160e2, second fluid manifold 200e2, and blood set components 30 and 24, such that, once separated, (i) first pump and valve engine 160e1 and first fluid manifold 200e1 can be replaced as needed, and (ii) second pump and valve engine 160e2, second fluid manifold 200e2, and blood set components 30 and 24 can be replaced as needed. After the replacement is completed, the first air pressure manifold 120e1 and the second air pressure manifold 120e2 slide back together along the housing.

[0241]

[0259] FIG. 16 also illustrates a blood set 100e (including all of the structures, functions, and alternatives described above with respect to the blood set 100 shown in FIG. 2). The blood set 100e is shown engaged with a pneumatic manifold 120e2 outside of a fluid management assembly 110e. This configuration simplifies the configuration, reduces the number of parts, and the like. Because the blood set 100e may be replaced frequently, it may be located outside the housing of the device 90 (e.g., on a wall or door that is visible and accessible (e.g., can be moved in and out of place)). The pump and valve engines 160e1 and 160e2 and the pneumatic manifolds 120e1 and 120e2 of the fluid management assembly 110e may be permanent or may be replaced infrequently (e.g., every six months or more), and therefore are located within the housing of the device 90.

[0242]

[0260] Referring now to FIG. 17, this figure schematically illustrates one embodiment of yet another alternative fluid management assembly 110f. Again, dual fluid manifolds 200f1 and 200f2 are aligned back-to-back. The first fluid manifold 200f1 operates in conjunction with a first pneumatic manifold 120f1 and multiple pump and valve engines 160f2, 160f3, and 160f4 according to any of the present disclosures provided herein. Meanwhile, the second fluid manifold 200f2 operates in conjunction with a second pneumatic manifold 120f2 and first pump and valve engine 160f1 according to any of the present disclosures provided herein. In an alternative embodiment, one, more, or all of the first through fourth pump and valve engines 160f1-160f4 are partially or completely removed in accordance with FIGS. 4 and 5.

[0243]

[0261] The first pneumatic manifold 120f1 and the second pneumatic manifold 120f2 may be hingedly connected to the housing of the device 90 for component removal as described above. In the illustrated embodiment, the first pneumatic manifold 120d1 and the second pneumatic manifold 120d2 are operatively connected to a control unit 50 for valve operation and sensor readout. The control unit 50 may control the electrical and signal functions of the device 90 and the entire system 10.

[0244]

[0262] Figure 17 is a cross-sectional view illustrating that the pneumatic manifold, pump / valve engine, and fluid manifold do not necessarily have a one-to-one relationship. In the case of a single pneumatic manifold, there may be (i) a single fluid manifold, (ii) a single fluid manifold and a single pump / valve engine, (iii) a single fluid manifold and multiple pump / valve engines, (iv) multiple fluid manifolds and a single pump / valve engine, and (v) multiple fluid manifolds and multiple pump / valve engines. In the case of a single pump / valve engine, there may be (i) a single pneumatic manifold and multiple fluid manifolds, (ii) multiple pneumatic manifolds and a single fluid manifold, and (iii) multiple pneumatic manifolds and multiple fluid manifolds. In the case of a single fluid manifold, there may be (i) a single pneumatic manifold and multiple pump / valve engines, (ii) multiple pneumatic manifolds and a single pump / valve engine, and (iii) multiple pneumatic manifolds and multiple pump / valve engines.

[0245]

[0263] 17 illustrates the modularity of the fluid management assembly 110f. As shown, different pump and valve engines may be attached to the same fluid manifold to perform different functions.

[0246]

[0264] 18A-18C, which schematically illustrate the modularity of fluid management assemblies of the present disclosure with fluid management assemblies 110g1-110g3. Fluid management assemblies 110g1-110g3 each include a different fluid manifold 200g1, 200g2, and 200g3. Fluid management assemblies 110g1-110g3 each include the same first pump and valve engine 160g1. Fluid management assembly 110g1 also includes second and third pump and valve engines 160g2 and 160g3. Fluid management assembly 110g2 also includes second and fourth pump and valve engines 160g2 and 160g4. Fluid management assembly 110g3 also includes second, third, and fourth pump and valve engines 160g2, 160g3, and 160g4. Thus, it is to be appreciated that one of each of the same pneumatic manifold, pump and valve engine, and fluid manifold may be modularly mixed and matched to produce entirely different fluid management assemblies (each with the desired functionality).

[0247]

[0265] 19A and 19B, which illustrate the above-described fluid management assembly 110d with additional mounting details, which may be applied to any of the medical fluid management assemblies of the present disclosure. FIG. 10 and associated text describe bolts or fasteners 390 and 394 that may be used to releasably hold together the fluid management assemblies of the present disclosure. FIG. 19A further describes that multiple bolts or fasteners 390a-390f may be used to hold together two or more of any of the pneumatic manifold, pump and valve engine, and fluid manifold. When bolts or fasteners 390a-390f are threaded into plastic components, the threaded metal inserts may form or adhere to the plastic components, allowing the desired amount of tightening to be achieved without cracking the plastic components.

[0248]

[0266] In the illustrated embodiment, bolts or fasteners 390a releasably hold pneumatic manifold 120d1, pump and valve engine 160d1, and fluid manifold 200d1 together. Bolts or fasteners 390b releasably hold pump and valve engine 160d1, fluid manifold 200d1, fluid manifold 200d2, and pump and valve engine 160d2 together. Bolts or fasteners 390c releasably hold pneumatic manifold 120d1 and pump and valve engine 160d1 together. Bolts or fasteners 390d releasably hold fluid manifold 200d1 and fluid manifold 200d2 together. Bolts or fasteners 390e releasably hold pneumatic manifold 120d2, pump and valve engine 160d2, and fluid manifold 200d2 together. Bolts or fasteners 390f releasably hold pneumatic manifold 120d2 and pump and valve engine 160d2 together.

[0249]

[0267] By removing outer bolts or fasteners 390a, 390c, 390e, and 390f, inner bolts or fasteners 390b and 390d are accessible. In this order, fluid management assembly 110d can be easily disassembled and any necessary components replaced. By reversing this order, fluid management assembly 110d with replaced components can be easily reassembled. FIG. 19B is a top or bottom view of fluid management assembly 110d, illustrating that inserting an array of bolts or fasteners from the outside of pneumatic manifold 120d1 or 120d2, for example, in a regular pattern, can ensure sufficient air pressure is evenly distributed along the entire fluid management assembly to adequately compress all gaskets and O-ring seals and provide a proper seal.

[0250]

[0268] 19A and 19B further illustrate that the use of mechanical quick-release clamps 398a, 398b, 398c, and 398d to releasably hold pneumatic manifolds 120d1, 120d2, pump and valve engines 160d1, 160d2, and fluid manifolds 200d1, 200d2 together in the x and y directions (but with bolts or fasteners 390a-390f fastened in the z direction) allows the various chambers, flexible membranes 190, 192, O-ring 144, and seat gaskets to be releasably and properly aligned in place prior to fastening in the z direction by fasteners 390a-390f and / or the structure and methods discussed with respect to FIG. 10. Quick-release clamps 398a, 398b, 398c, and 398d may be used exclusively or in conjunction with bolts and / or other fasteners.

[0251]

[0269] It is understood that various changes and modifications to the preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims. The present disclosure also includes the following embodiments. [Embodiment 1] 1. A medical fluid management assembly comprising: the medical fluid management assembly comprising a pneumatic manifold including a plurality of plates sealed together to form a plurality of pneumatic passageways, at least one of the plates defining a pneumatic valve chamber and a pneumatic pump chamber, the pneumatic valve chamber in pneumatic communication with at least one of the pneumatic passageways, and the pneumatic pump chamber in pneumatic communication with at least one of the pneumatic passageways; the medical fluid management assembly comprises a fluid manifold including a plurality of fluid paths, the fluid manifold defining a fluid valve chamber and a fluid pump chamber, the fluid valve chamber being in selective fluid communication with at least one of the fluid pump chambers and the fluid paths; (a) the pneumatic valve chamber and the fluid valve chamber being in mating engagement to apply pressure to at least one flexible valve chamber membrane or a valve chamber area of ​​at least one common flexible membrane; (b) the pneumatic pump chamber and the fluid pump chamber being in mating engagement to apply pressure to at least one flexible pump membrane or a pump chamber area of ​​the at least one common flexible membrane; A medical fluid management assembly comprising at least one of: (i) the pneumatic valve chamber extending outward from the at least one plate; (ii) the pneumatic pump chamber extending outward from the at least one plate; (iii) the fluid valve chamber extending outward from the fluid manifold; and (iv) the fluid pump chamber extending outward from the fluid manifold to assist in applying pressure to a corresponding at least one flexible membrane or at least one flexible membrane area. [Embodiment 2] 2. A medical fluid management assembly as described in embodiment 1, wherein the plurality of pneumatic passages are formed in at least one of the plates and sealed by a gasket compressed between the plates. [Embodiment 3] A medical fluid management assembly as described in embodiment 1, wherein the fluid manifold includes a plurality of fluid plates, at least one of which forms the plurality of fluid paths, and the fluid plates are sealed together to seal the fluid paths. [Embodiment 4] 2. A medical fluid management assembly as described in embodiment 1, comprising at least one electrically actuated pneumatic solenoid valve secured to the pneumatic manifold and in selective pneumatic communication with at least one of the pneumatic passages. [Embodiment 5] A medical fluid management assembly as described in embodiment 1, comprising at least one conductivity sensor having a conductive insert held by the fluid manifold, the insert being positioned along one of the fluid paths, the conductivity sensor further having a conductive conductivity probe held by the pneumatic manifold, the conductivity probe engaged with the conductive insert. [Embodiment 6] A medical fluid management assembly as described in embodiment 1, wherein the pneumatic valve chamber and the fluid valve chamber are a first pneumatic valve chamber and a first fluid valve chamber, and the medical fluid management assembly includes a second pneumatic valve chamber and a second fluid valve chamber, the second fluid valve chamber being selectively fluidly connected to a first balance chamber, and the first balance chamber being separated from a second balance chamber by at least one balance chamber membrane or a balance chamber area of ​​the at least one common flexible membrane. [Embodiment 7] 7. A medical fluid management assembly as described in embodiment 6, wherein the first fluid valve chamber is in selective fluid communication with the second fluid valve chamber. [Embodiment 8] 7. A medical fluid management assembly as described in embodiment 6, wherein the first balance chamber and the second balance chamber are provided as part of the fluid manifold. [Embodiment 9] A medical fluid management assembly as described in embodiment 1, comprising a water accumulation chamber, the water accumulation chamber having at least one water accumulation chamber membrane or a water accumulation chamber area of ​​the at least one common flexible membrane for expanding when the amount of water contained in the water accumulation chamber increases and for contracting when the amount of water contained in the water accumulation chamber decreases. [Embodiment 10] 10. A medical fluid management assembly as described in embodiment 9, wherein the water accumulation chamber is in selective fluid communication with the fluid valve chamber. [Embodiment 11] 10. A medical fluid management assembly as described in embodiment 9, wherein the water accumulation chamber is provided as part of the fluid manifold. [Embodiment 12] 2. A medical fluid management assembly as described in embodiment 1, comprising a mixing chamber having a plurality of fluid inlets and fluid outlets. [Embodiment 13] 13. A medical fluid management assembly as described in embodiment 12, wherein the mixing chamber is in selective fluid communication with the fluid valve chamber. [Embodiment 14] 13. A medical fluid management assembly as described in embodiment 12, wherein the mixing chamber is provided as part of the fluid manifold. [Embodiment 15] A medical fluid management assembly as described in embodiment 1, wherein (i) the pneumatic manifold is a first pneumatic manifold and the medical fluid management assembly comprises a second pneumatic manifold that operates in conjunction with the fluid manifold, or (ii) the fluid manifold is a first fluid manifold and the medical fluid management assembly comprises a second fluid manifold that operates in conjunction with the pneumatic manifold. [Embodiment 16] 2. A medical fluid management assembly as described in embodiment 1, wherein the fluid manifold includes an ultrafiltration device in selective fluid communication with the fluid pump chamber.

Claims

1. an air pressure source; Purified water line, a concentrate line; An extracorporeal circuit introduction unused dialysis fluid line, an extracorporeal circuit lead-out post-use dialysate line; A discharge line; 1. A first medical fluid management assembly, comprising: a first pneumatic manifold in pneumatic communication with the pneumatic supply source, the first manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a first pump and valve engine including a plurality of valve chambers and at least one pump chamber, the first pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the first pneumatic manifold, the first pump and valve engine further including a plurality of fluid connectors; a first fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the first pump and valve engine, the first fluid manifold being in fluid communication with the purified water line, the concentrate line, and the extracorporeal circuit inlet fresh dialysate line; a first medical fluid management assembly; a second medical fluid management assembly, a second pneumatic manifold in pneumatic communication with the pneumatic supply source, the second manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a second pump and valve engine including a plurality of valve chambers and at least one pump chamber, the second pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the second pneumatic manifold, the second pump and valve engine further including a plurality of fluid connectors; a second fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the second pump and valve engine, the second fluid manifold being in fluid communication with the drain line and the extracorporeal circuit outlet spent dialysate line; a second medical fluid management assembly; A medical fluid device comprising:

2. The medical fluid device of claim 1 , wherein the first medical fluid management assembly is located in a first portion of the medical fluid device and the second medical fluid management assembly is located in a second portion of the medical fluid device.

3. 2. The medical fluid device of claim 1, wherein at least one of the first pump and valve engine and the second pump and valve engine are contained within a fluid pumping cassette that is removably attached to at least one of the first pneumatic manifold or the second pneumatic manifold, respectively.

4. 2. The medical fluid device of claim 1, wherein each of the first and second pneumatic manifolds includes a plurality of plates engaged with one another, at least one of the plates defining a groove that forms the pneumatic passageway.

5. 10. The medical fluid device of claim 1, wherein the first and second pump and valve engines each include first and second rigid plates at least partially separated by at least one flexible membrane.

6. 6. The medical fluid device of claim 5, wherein the first and second rigid plates are separated by the at least one flexible membrane in areas defining pump and valve chambers.

7. 7. The medical fluid device of claim 6, wherein the first and second rigid plates further define at least one of a balancing chamber, a water accumulation chamber, a mixing chamber, a water degassing chamber, or a dialysate degassing chamber.

8. 2. The medical fluid device of claim 1, wherein each of the first and second fluid manifolds includes at least one rigid plate that forms the plurality of fluid paths, or a plurality of rigid plates sealed to one another to form the plurality of fluid paths.

9. 10. The medical fluid device of claim 1, wherein the first fluid manifold is integrally formed with the second fluid manifold.

10. 10. The medical fluid system of claim 1, further comprising a dialysis machine fluidly connected to the extracorporeal circuit inlet fresh dialysate line and the extracorporeal circuit outlet spent dialysate line.

11. the first pump and valve engine includes a mixing chamber; 10. The medical fluid device of claim 1, wherein the first pump and valve engine is configured to mix purified water received from the purified water line with a concentrate in the mixing chamber.

12. 12. The medical fluid device of claim 11, further comprising at least one conductivity sensor, the conductivity sensor having a conductive insert carried by the first fluid manifold, the insert being positioned along one of the fluid paths, the conductivity sensor further including a conductive conductivity probe carried by the first pneumatic manifold, the conductivity probe engaging the conductive insert to provide a measurement indicating whether the purified water and the concentrate have been mixed according to a specified mixing concentration.

13. an air pressure source; a fresh dialysate line; An extracorporeal circuit introduction unused dialysis fluid line, an extracorporeal circuit lead-out post-use dialysate line; A discharge line; 1. A first medical fluid management assembly, comprising: a first pneumatic manifold in pneumatic communication with the pneumatic supply source, the first manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a first pump and valve engine including a plurality of valve chambers and at least one pump chamber, the first pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the first pneumatic manifold, the first pump and valve engine further including a plurality of fluid connectors; a first fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the first pump and valve engine, the first fluid manifold being in fluid communication with the fresh dialysate line and the extracorporeal circuit inlet fresh dialysate line; a first medical fluid management assembly; a second medical fluid management assembly, a second pneumatic manifold in pneumatic communication with the pneumatic supply source, the second manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a second pump and valve engine including a plurality of valve chambers and at least one pump chamber, the second pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the second pneumatic manifold, the second pump and valve engine further including a plurality of fluid connectors; a second fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the second pump and valve engine, the second fluid manifold being in fluid communication with the drain line and the extracorporeal circuit outlet spent dialysate line; a second medical fluid management assembly; a dialysis machine fluidly connected to the extracorporeal circuit inlet fresh dialysate line and the extracorporeal circuit outlet used dialysate line; A medical fluid device comprising:

14. 14. The medical fluid device of claim 13, wherein the first fluid manifold is integrally formed with the second fluid manifold.

15. 14. The medical fluid device of claim 13, wherein at least one of the first pump and valve engine and the second pump and valve engine are contained within a fluid pumping cassette that is removably attached to the first pneumatic manifold or the second pneumatic manifold, respectively.

16. an air pressure source; A blood filter introduction line, a blood filter outlet line; Arterial line and Intravenous line and a blood filter fluidly connected to the blood filter inlet line and the blood filter outlet line; 1. A first medical fluid management assembly, comprising: a first pneumatic manifold in pneumatic communication with the pneumatic supply source, the first manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a first pump and valve engine including a plurality of valve chambers and at least one pump chamber, the first pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the first pneumatic manifold, the first pump and valve engine further including a plurality of fluid connectors; a first fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the first pump-valve engine, the first fluid manifold being in fluid communication with the blood filter outlet line and the venous line; a first medical fluid management assembly; a second medical fluid management assembly, a second pneumatic manifold in pneumatic communication with the pneumatic supply source, the second manifold including a plurality of pneumatic passages and a plurality of pneumatic connectors; a second pump and valve engine including a plurality of valve chambers and at least one pump chamber, the second pump and valve engine including a plurality of pneumatic connectors sealingly and releasably engaged with the pneumatic connectors of the second pneumatic manifold, the second pump and valve engine further including a plurality of fluid connectors; a second fluid manifold including a plurality of fluid paths and a plurality of fluid connectors sealingly and releasably engaged with the fluid connectors of the second pump and valve engine, the second fluid manifold being in fluid communication with the blood filter introduction line and the arterial line; a second medical fluid management assembly; A medical fluid device comprising:

17. 17. The medical fluid device of claim 16, wherein the blood filter comprises a septic filter.

18. 17. The medical fluid device of claim 16, wherein the first fluid manifold is integrally formed with the second fluid manifold.

19. 17. The medical fluid device of claim 16, wherein at least one of the first pump and valve engine and the second pump and valve engine are contained within a fluid pumping cassette that is removably attached to at least one of the first pneumatic manifold or the second pneumatic manifold, respectively.

20. a first valve that selectively supplies air pressure or atmospheric pressure to the air pressure passage of the first air pressure manifold; a second valve that selectively supplies air pressure or atmospheric pressure to the air pressure passage of the second air pressure manifold; a control unit electrically connected to the first valve and the second valve and configured to control operation of the first valve and the second valve; 17. The medical fluid device of claim 16, further comprising:

21. 21. The medical fluid device of claim 20, wherein at least one of the first valve or the second valve is a pneumatic solenoid valve.

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