Drainage apparatus for a hemodialysis machine

Abstract

The present disclosure relates to dialysis systems and methods. In some embodiments, a dialysis system includes a dialysis machine having a fluid line and a drain line, a blood line set configured to connect to the dialysis machine, and a drain apparatus coupled to the dialysis machine. The drain apparatus includes a chamber configured to receive an end of a patient line of the blood line set, an input line, an output line, and a valve. The input line has a first end configured to couple to the chamber and a second end configured to couple to the fluid line of the dialysis machine. The output line has a first end configured to couple to the chamber and a second end configured to couple to the drain line of the dialysis machine. The valve is configured to control flow of fluid through the output line.

Description

Technical Field

[0001] This disclosure relates to dialysis systems and methods. Background Technology

[0002] Dialysis is a treatment used to support patients with impaired kidney function. The two main types of dialysis are hemodialysis and peritoneal dialysis.

[0003] During hemodialysis (“HD”), a patient’s blood passes through the dialyzer of a dialysis machine, along with a dialysate or dialysate. A semipermeable membrane within the dialyzer separates the blood from the dialysate and allows diffusion and osmotic exchange to occur between the dialysate and the blood flow. These transmembrane exchanges remove waste products from the blood, including solutes such as urea and creatinine. These exchanges also regulate the levels of other substances in the blood, such as sodium and water. In this way, the dialysis machine acts as an artificial kidney to purify the blood.

[0004] During peritoneal dialysis (“PD”), a patient’s peritoneal cavity is periodically infused with dialysis solution or dialysate. The membranous lining of the patient’s peritoneum acts as a natural semipermeable membrane, allowing diffusion and osmotic exchange between the solution and the bloodstream. These exchanges across the patient’s peritoneum, much like the continuous exchanges across the dialyzer in HD, enable the removal of waste products from the blood, including solutes such as urea and creatinine, and regulate the levels of other substances in the blood, such as sodium and water.

[0005] Many PD machines are designed to automatically inject, retain, and drain dialysate into a patient's peritoneal cavity. Treatment typically lasts several hours and usually begins with an initial drain cycle to empty the peritoneal cavity of used or spent dialysate. The sequence then proceeds sequentially through a series of filling, retaining, and draining phases. Each phase is called a cycle. Summary of the Invention

[0006] In one aspect, a dialysis system includes a dialysis machine having a fluid line and an outlet line, a blood line assembly configured to be connected to the dialysis machine, and an outlet device coupled to the dialysis machine. The outlet device includes a chamber configured to receive an end of a patient line from the blood line assembly, an inlet line, an outlet line, and a valve. The inlet line has a first end configured to be coupled to the chamber and a second end configured to be coupled to the fluid line of the dialysis machine. The outlet line has a first end configured to be coupled to the chamber and a second end configured to be coupled to the outlet line of the dialysis machine. The valve is coupled to the outlet line and configured to control the flow of fluid through the outlet line.

[0007] In another aspect, the discharge device for a dialysis machine includes a chamber, a cover, an inlet line, an outlet line, and a valve. The chamber is configured to receive the end of a fluid line extending from the dialysis machine. The cover is configured to be coupled to the chamber to form a seal with it. The inlet line has a first end configured to be coupled to the chamber and a second end configured to be coupled to the fluid line of the dialysis machine. The outlet line has a first end configured to be coupled to the chamber and a second end configured to be coupled to the outlet line of the dialysis machine. The valve is coupled to the outlet line and configured to control the flow of fluid through the outlet line.

[0008] In another aspect, a method includes evacuating the contents of a blood tubing set of a dialysis system into a chamber of a discharge device of the dialysis system, closing the cover of the discharge device to seal the chamber of the discharge device, allowing disinfectant fluid to flow from the dialysis machine of the dialysis system to the discharge device through the input line of the discharge device to at least partially fill the chamber of the discharge device with disinfectant fluid, and allowing disinfectant fluid to flow from the discharge device to the discharge line of the dialysis machine through the output line of the discharge device.

[0009] The implementation may include one or more of the following features.

[0010] In some embodiments, the fluid lines and the discharge lines are part of the hydraulic circuit of the dialysis machine, and the dialysis system also includes a dialyzer connected to the hydraulic circuit of the dialysis machine.

[0011] In some implementations, the discharge line is located downstream of the dialyzer.

[0012] In some embodiments, the fluid line is located upstream of the dialyzer.

[0013] In some embodiments, the second end of the output line is configured to be coupled to the discharge line at a location upstream of the dialyzer post-flow pump of the dialysis machine.

[0014] In some embodiments, the second end of the output line is configured to be coupled to the discharge line at a location downstream of the discharge valve of the dialysis machine.

[0015] In some embodiments, the discharge device further includes a pump coupled to the output line and configured to pump fluid from the chamber of the discharge device to the discharge line of the dialysis machine.

[0016] In some embodiments, the discharge device is configured to discharge fluid contained in the chamber of the discharge device by gravity to the discharge line of the dialysis machine when the valve of the discharge device is in the open position.

[0017] In some implementations, the second end of the input line is configured to be coupled to a portion of the fluid line located downstream of the fluid filter of the dialysis machine.

[0018] In some embodiments, the discharge device includes a cover coupled to the chamber and configured to form a seal with the chamber.

[0019] In some embodiments, the cover includes an exhaust port and a hydrophobic filter disposed within the exhaust port.

[0020] In some embodiments, the chamber includes an inner funnel coupled to and nested within the outer funnel.

[0021] In some embodiments, the inner funnel and the outer funnel form an annular channel, and the first end of the input line is fluidly connected to the annular channel.

[0022] In some embodiments, the annular channel is formed between the outer surface of the inner funnel and the inner surface of the outer funnel.

[0023] In some embodiments, the discharge device further includes a pump coupled to the output line.

[0024] In some embodiments, the discharge device further includes one or more mechanical attachments coupled to the chamber and configured to position the end of a patient tubing extending from the dialysis machine within the chamber.

[0025] In some embodiments, the discharge device further includes an exhaust port extending through the cover and a hydrophobic membrane coupled to the exhaust port.

[0026] In some embodiments, the discharge device further includes a sensor configured to detect the fluid level in the chamber.

[0027] In some embodiments, the sensor includes a pressure sensor coupled to the output line.

[0028] In some embodiments, the sensor includes an ultrasonic sensor coupled to the chamber.

[0029] In some embodiments, the sensor includes an ultrasonic sensor and an ultrasonic receiver coupled to the cover.

[0030] In some embodiments, the sensor includes a light emitter and a light receiver coupled to the cover.

[0031] In some implementations, the sensor includes one or more electrodes coupled to the chamber.

[0032] In some embodiments, the cover includes one or more vent holes.

[0033] In some embodiments, emptying the contents of the blood tubing set of the dialysis system into the chamber of the dialysis system's discharge device includes: connecting the patient tubing of the blood tubing set to the discharge device of the dialysis machine after dialysis is performed on the patient; allowing saline solution to flow through the patient tubing of the blood tubing set into the discharge device to flush the remaining fluid in the blood tubing set into the discharge device; and disconnecting the patient tubing of the blood tubing set from the discharge device.

[0034] In some embodiments, the method further includes stopping the flow of the disinfectant fluid upon receiving a signal from a sensor coupled to the discharge device indicating that the chamber of the discharge device is filled with disinfectant solution.

[0035] In some embodiments, the disinfectant fluid remains in the chamber of the discharge device for a predetermined amount of time.

[0036] In some embodiments, allowing disinfectant fluid to flow from the discharge device to the discharge line of the dialysis machine via the discharge line of the discharge device includes: opening a valve coupled to the discharge line of the discharge device.

[0037] In some embodiments, the discharge line that allows disinfectant fluid to flow from the discharge device to the dialysis machine via the discharge line includes pumping disinfectant fluid from the chamber of the discharge device into the discharge line using a pump coupled to the discharge line of the discharge device.

[0038] In some embodiments, allowing disinfectant fluid to flow from the discharge device to the discharge line of the dialysis machine via the discharge line of the discharge device includes: using negative pressure generated by a flow pump of the dialysis machine to pump the disinfectant fluid in the chamber of the discharge device to the discharge line.

[0039] In some embodiments, the disinfectant fluid includes a chemical disinfectant.

[0040] In some embodiments, the disinfectant fluid is hot water.

[0041] In some embodiments, allowing disinfectant fluid to flow from the dialysis machine to the discharge device through the inlet line of the discharge device to at least partially fill the chamber of the discharge device includes: allowing the disinfectant fluid to flow into the chamber at a flow rate sufficient to maintain a predetermined fluid level in the chamber for a predetermined amount of time.

[0042] The advantages of the systems, apparatus, and methods described herein include ease of use for users. By providing a drain device coupled to the drain line of the dialysis machine, the evacuation and disinfection of the drain device after perfusion or flushing of the patient tubing is simplified by reducing the need for draining and disinfecting a separate drain device from the dialysis machine. Another advantage is that by combining the disinfection of the drain device used for perfusion and flushing of the patient tubing with the disinfection of the dialysis machine, the total time required for disinfecting both the drain device and the dialysis machine is reduced. Another advantage is the reduced risk of leakage and biohazards. For example, because the drain device can be disinfected and drained while remaining connected to the dialysis machine, the need for transporting the drain device for disinfection is greatly reduced, thereby significantly reducing the risk of spillage of the contents of the drain device (e.g., patient tubing fluid).

[0043] Other aspects, features and advantages will be apparent from the description and drawings as well as from the claims. Attached Figure Description

[0044] Figure 1 It is a perspective view of a hemodialysis system including the discharge equipment coupled to the dialysis machine.

[0045] Figure 2 yes Figure 1 A cross-sectional view of the discharge equipment.

[0046] Figure 3 yes Figure 1 A perspective view of the discharge device in the open position, wherein the patient tubing of the hemodialysis system is coupled to the discharge device.

[0047] Figure 4 yes Figure 1 A perspective view of the discharge device in the closed position.

[0048] Figure 5 yes Figure 1 A schematic diagram of the dialysate circuit of a hemodialysis system, wherein the discharge device is coupled to the dialysate circuit.

[0049] Figure 6 yes Figure 1 A schematic diagram of the blood circuit of a hemodialysis system.

[0050] Figure 7 yes Figure 5A schematic diagram of the dialysate circuit, showing an alternative coupling from the discharge device to the dialysate circuit.

[0051] Figure 8 yes Figure 5 A schematic diagram of the dialysate circuit, showing an alternative coupling from the discharge device to the dialysate circuit.

[0052] Figure 9-15 It is used for Figure 1 A cross-sectional view of an alternative drainage device for a hemodialysis system.

[0053] Figure 16 yes Figure 1 A schematic diagram of the blood circuit and drainage equipment of a hemodialysis system.

[0054] Figure 17 yes Figure 1 A cross-sectional view of an alternative drainage device for a hemodialysis system.

[0055] Figure 18 yes Figure 1 A schematic diagram of the blood circuit and drainage equipment of a hemodialysis system. Detailed Implementation

[0056] refer to Figure 1 The hemodialysis system 100 includes a hemodialysis machine 102, and a disposable blood component assembly 104 forming a blood circuit is connected to the hemodialysis machine 102. During hemodialysis, arterial and venous patient lines 106, 108 of the blood component assembly 104 are connected to a patient, and blood circulates through various blood lines and components of the blood component assembly 104, including a dialyzer 110. Simultaneously, dialysate circulates through the dialysate circuit formed by the dialyzer 110 and various other dialysate components and fluid lines connected to the hemodialysis machine 102. Figure 5 (As shown). Many of these dialysate components and fluid lines are located within the housing of the hemodialysis machine 102, therefore... Figure 1 The dialysate is invisible. Dialysate passes through dialyzer 110 along with blood. The blood and dialysate passing through dialyzer 110 are separated from each other by a semi-permeable structure of dialyzer 110 (e.g., a semi-permeable membrane and / or semi-permeable microtubes). Due to this arrangement, toxins are removed from the patient's blood and collected in the dialysate. The filtered blood leaving dialyzer 110 is returned to the patient. The dialysate leaving dialyzer 110 includes the toxins removed from the blood and is commonly referred to as "used dialysate." Used dialysate is directed from dialyzer 110 to the discharge system via discharge line 112.

[0057] Still referencing Figure 1The dialysate circuit of the hemodialysis machine 102 is formed by a plurality of dialysate components and fluid lines located within the housing of the hemodialysis machine 102, and a dialyzer 110, a dialyzer inlet line 134, and a dialyzer outlet line 136 located outside the housing of the hemodialysis machine 102. The dialyzer inlet line 134 includes a connector adapted to connect to one end region of the dialyzer 110, and the dialyzer outlet line 136 includes a connector adapted to connect to the other end region of the dialyzer 110.

[0058] Still referencing Figure 1 The hemodialysis machine 102 includes a touchscreen 118 and a control panel 120. The touchscreen 118 and control panel 120 allow the operator to input various treatment parameters into the hemodialysis machine 102 and otherwise control the hemodialysis machine 102. Furthermore, the touchscreen 118 serves as a display for conveying information to the operator of the hemodialysis system 100. A speaker 122 is positioned below the touchscreen 118 and is used to provide audio signals to the operator of the system 100. Therefore, during use, the hemodialysis machine 102 can provide visual alarms to the operator of the system 100 via the touchscreen 118 and audio alarms to the operator of the system 100 via the speaker 122.

[0059] The blood component assembly 104 of the hemodialysis system is fixed to a module 114 attached to the front of the hemodialysis machine 102. Module 114 includes a blood pump 116 capable of driving blood through the blood circuit. Module 114 also includes various other instruments capable of monitoring the blood flowing through the blood circuit. Module 114 includes a door 140, such as... Figure 1 As shown, when closed, door 140 cooperates with the front of module 114 to form a compartment sized and shaped to receive blood component assembly 104. In the closed position, door 140 presses certain blood components of blood component assembly 104 against corresponding instruments exposed on the front of module 114. This arrangement facilitates control of blood flow through the blood circuit and monitoring of blood flowing through the blood circuit.

[0060] like Figure 1 As shown, the hemodialysis system 100 also includes a discharge device 200 coupled to the hemodialysis machine 102. The discharge device 200 includes a cover 202, an inlet port 204, an outlet port 206, an inlet line 210, an outlet line 212, a discharge device pump 214, and an outlet valve 216.

[0061] In some embodiments, the cover 202 is hinged to the body of the discharge device 200. During use, the cover 202 of the discharge device 200 can be opened, and the intravenous patient line 108 of the blood component collection 104 can be placed in the chamber of the discharge device 200 to drain fluid from the intravenous patient line 108 into the chamber of the discharge device 200.

[0062] Components of the hemodialysis machine 102 and the discharge device 200 can be sterilized between treatments. For example, disinfectant fluid can be supplied to and circulated through the hydraulic circuits of the hemodialysis machine 102 and the discharge device 200 between treatments to sterilize the hemodialysis machine 102 and the discharge device 200. As described further in detail herein, the discharge device 200 can be sterilized when not in use by closing the cover 202 and allowing disinfectant fluid to flow through the chamber of the discharge device 200.

[0063] Figure 2 A cross-sectional view of the discharge device 200 with the cover 202 closed is depicted. (See figure) Figure 2 As shown, the discharge device includes an inner funnel 218 and an outer funnel 220. The inner funnel 218 forms a chamber 208 within the discharge device 200 configured to receive and collect liquid. The outer funnel 220 includes an upper lip 222 surrounding an annular surface 224 of the inner funnel 218. The inner funnel 218 of the discharge device 200 is nested within and connected to the outer funnel 220 of the discharge device 200. Figure 2 As shown, the inner funnel 218 is connected to the outer funnel 220 near the discharge port 206 of the discharge device 200. The inner funnel 218 can be connected to the outer funnel 220 by any suitable technique such as welding or injection molding.

[0064] The nested arrangement of the inner funnel 218 and the outer funnel 220 forms an annular channel 228 between the inner funnel 218 and the outer funnel 220 surrounding the inner funnel 218. Fluid received from the inlet line 210 through the inlet port 204 can travel through the annular channel 228 between the inner funnel 218 and the outer funnel 220, across the annular surface 224 of the inner funnel 218, and into the chamber 208 of the discharge device. The arrangement of the inner funnel 218 and the outer funnel 220 to form a 360-degree annular channel 228 allows the fluid to be distributed fairly uniformly across the entire surface of the chamber 208 of the discharge device 200. In some examples, the inner funnel 218 and the outer funnel 220 are arranged to form an annular channel 228 with a width of approximately 0.125 inches to approximately 0.25 inches.

[0065] The inner funnel 218 and outer funnel 220 of the discharge device 200 can be formed from any of a variety of different medical-grade materials. Examples of such materials include PVC, polyethylene, polypropylene, silicone, polyurethane, high-density polyethylene, nylon, ABS, acrylic, Isoplast, polyisoprene, polycarbonate, stainless steel, glass, titanium, carbon fiber, and ceramic.

[0066] like Figure 2As shown, clip 226 is attached to the upper lip 222 of the outer funnel 220. Clip 226 is configured to receive the intravenous patient line 108 of the hemodialysis system 100 and position the patient end of the intravenous patient line 108 within the chamber 208 of the discharge device. As described in further detail herein, chamber 208 is configured to collect fluid contained within the blood line and provide the collected fluid to the discharge system via the output line 212 of the discharge device 200.

[0067] Still referencing Figure 2 The discharge device 200 also includes a screen 236 located within and coupled to an inner funnel 218 of the discharge device 200. The screen 236 is configured to prevent particles exceeding a defined size from entering and potentially clogging the output line 212. For example, the screen 236 includes multiple openings sized to allow fluid flow through the screen 236 while preventing particles exceeding a defined size from entering the output line 212. In some examples, the screen 236 includes openings having a diameter of approximately 0.10 inches to approximately 0.15 inches (e.g., 0.125-inch diameter). The positioning of the screen 236 within the chamber 208 prevents blood lines positioned within the chamber 208 using clamps 226 from contacting the screen 236. In some embodiments, the screen 236 is removable and can be removed from the discharge device 200 for cleaning. The screen 236 can be formed from any of a variety of different medical-grade materials. Examples of such materials include PVC, polyethylene, polypropylene, silicone, polyurethane, high-density polyethylene, nylon, ABS, acrylic, Isoplast, polyisoprene, polycarbonate, stainless steel, titanium, and carbon fiber.

[0068] like Figure 2As shown, the cover 202 of the discharge device 200 includes an exhaust port 230 with a hydrophobic filter 232. The exhaust port 230 extends through the cover 202 to the outside of the discharge device 200. A coupler 234 is coupled to the exhaust port 230 to form a fluid seal between the exhaust port 230 and the cover 202. The hydrophobic filter 232 is disposed within the exhaust port 230. As described in further detail herein, when the chamber 208 of the discharge device 200 is filled with fluid, the air contained within the chamber 208 is displaced by the fluid and exits through the exhaust port 230, thereby allowing complete filling of the chamber 208. Furthermore, the hydrophobic filter 232 prevents liquid supplied to the chamber 208 from flowing out through the exhaust port 230. The hydrophobic filter 232 may be made of a hydrophobic material such as polytetrafluoroethylene (PTFE) (e.g., expanded polytetrafluoroethylene (ePTFE)), polyethylene, and carboxymethyl cellulose. In some embodiments, the hydrophobic filter 232 is a fiber carrier having an entangled braided layer coated with ePTFE or other microporous material. The vent 230 may include a plurality of pores, each having a diameter of approximately 15 μm to approximately 45 μm (e.g., 30 μm). In some examples, the material of the vent 230 expands in response to contact with fluid, thereby closing the plurality of pores in the vent 230 and preventing fluid from passing through the vent 230.

[0069] Still referencing Figure 2 The input port 204 of the discharge device 200 is coupled to the input line 210. In some embodiments, the input line 210 is coupled to the input port 204 using a coupler. The input line 210 can be coupled to the input port 204 using a metal or plastic strip that surrounds barbs around the input port 204 to restrict the tube of the input line 210. A first end of the input line 210 is coupled to the input port 204, and a second end of the input line 210 is coupled to the fluid line of the hemodialysis machine 102.

[0070] exist Figure 2 In the illustrated embodiment, the discharge device inlet valve 242 is fluidly connected to the inlet line and configured to control the flow of fluid entering chamber 208 via inlet line 210. The discharge device inlet valve 242 can be communicatively coupled to hemodialysis machine 102 and can open and close in response to signals received from hemodialysis machine 102. An example of a suitable valve is a solenoid valve.

[0071] The output port 206 of the discharge device 200 is coupled to the output line 212. In some embodiments, the output line 212 is coupled to the output port 206 using a coupler. The output line 212 can be coupled to the output port 206 using a metal or plastic strip that surrounds barbs around the output port 206 to restrict the tube of the output line 212. As described in further detail herein, a first end of the output line 212 is coupled to the output port 206 and a second end of the output line 212 is coupled to the discharge line 112 of the hemodialysis machine 102.

[0072] The discharge device output valve 216 is fluidly connected to the output line 212 of the discharge device 200 and is configured to control the flow of fluid from the output line 212 to the discharge line 112. In some embodiments, the discharge device output valve 216 is communicatively coupled to the hemodialysis machine 102 and can open and close in response to a signal received from the hemodialysis machine 102. An example of a suitable valve is a solenoid valve.

[0073] like Figure 2 As shown, the discharge pump 214 is fluidly coupled to the output line 212 of the discharge device 200. The discharge pump 214 is configured to pump fluid from the chamber 208 of the discharge device 200 through the output line 212 to the discharge line 112 of the hemodialysis machine 102. Any of a variety of suitable pumps can be used, such as peristaltic pumps, piston pumps, impeller pumps, magnetically driven gear pumps, etc.

[0074] The inlet line 210 and outlet line 212 of the discharge device 200 can be formed from any of a variety of different medical-grade materials. Examples of such materials include PVC, polyethylene, polypropylene, silicone, polyurethane, high-density polyethylene, nylon, ABS, acrylic, Isoplast, polyisoprene, and polycarbonate.

[0075] Still referencing Figure 2 Pressure sensor 240 is coupled to the output line 212 of discharge device 200 near output port 206. Pressure sensor 240 is configured to measure the fluid pressure in chamber 208 of discharge device 200. For example, when chamber 208 is filled with disinfectant fluid, the pressure within chamber 208 can be measured by pressure sensor 240 to determine when chamber 208 is full of disinfectant fluid based on the pressure in chamber 208. In some embodiments, pressure sensor 240 is an in-line pressure transducer. Other types of pressure sensors that can be used include those such as the M3200 pressure transducer.

[0076] Figure 3 Depicting Figure 1A perspective view of the discharge device 200, wherein the cover 202 of the discharge device 200 is in the open position and the intravenous patient line 108 is attached to the discharge device 200 via clip 226. Figure 4 A perspective view of the discharge device 200 with its cover 202 in the closed position is depicted. (See image.) Figure 3 and 4 As shown, the cover 202 is attached to the outer funnel 220 via a hinge 238, allowing the cover 202 to... Figure 3 The opening position described in the text is the same as Figure 4 The cover 202 moves between the closed positions depicted herein. When in the closed position, the cover 202 forms a seal with the outer funnel 220 to seal the chamber 208, preventing fluid from escaping from the top of the chamber 208. The cover 202 can be opened or closed based on the procedure being performed by the hemodialysis machine or the stage of hemodialysis treatment. For example, the cover 202 can be opened to receive the intravenous patient line 108 for draining the contents of the intravenous patient line 108 into the draining device. The cover 202 can be closed during sterilization of the draining device 200, as described in further detail herein.

[0077] As mentioned above, Figure 1 The dialysate circuit of the hemodialysis machine 102 is formed by multiple dialysate components and fluid lines located inside the housing of the hemodialysis machine 102, and dialyzer 110, dialyzer input line 134 and dialyzer output line 136 located outside the housing of the hemodialysis machine 102.

[0078] Figure 5 This is a schematic diagram illustrating the flow path of fluid entering, passing through, and exiting the dialysate circuit 500. The dialysate circuit 500 includes multiple dialysate components that are fluidly connected to each other via a series of fluid lines and a discharge line 112.

[0079] Still referencing Figure 5 The water inlet port 502 is configured to receive water from an external source and supply water to the heat exchanger 506 via a fluid line. The heat exchanger 506 is configured to use the heat from the used dialysate (or other fluid) flowing on the opposite side of the heat exchanger 506 to heat the water received by the dialysate circuit 500 through the water inlet port 502.

[0080] After leaving heat exchanger 506, the heated water flows to deaeration and heating chamber 512. Deaeration and heating chamber 512 is configured to heat and deaerate the water received by dialysate circuit 500 via water inlet port 502. Deaeration and heating chamber 512 includes a temperature-controlled thermistor 514 for monitoring the temperature of the heated water and a heater 516 for increasing the temperature of the water received by deaeration and heating chamber 512. For example, if the temperature of the water received by deaeration and heating chamber 512 is below a threshold temperature, as detected by temperature-controlled thermistor 514, heater 516 can be used to heat the water above the threshold temperature. Aeration port 518 is located between two sub-chambers 512C, 512D and is configured to deaerate the water flow when deaeration pump 520 pumps water from sub-chamber 512A to sub-chamber 512E.

[0081] Heated and degassed water flows from sub-chamber 512E to mixing chambers 534 and 536, where water, acid concentrate, and bicarbonate concentrate are mixed. Dialysis circuit 500 includes an acid concentrate pump 526 coupled to an acid concentrate source. Acid concentrate pump 526 is configured to pump the acid concentrate into the water flow from degassed and heated chamber 512 to mixing chambers 534 and 536.

[0082] The dialysate circuit 500 also includes a bicarbonate pump 532 coupled to a bicarbonate source. The bicarbonate pump 532 is configured to pump bicarbonate into a concentrated water and acid stream between the degassing and heating chamber 512 and the mixing chambers 534, 536.

[0083] Mixing chambers 534 and 536 are fluidly connected to downstream fluid lines of the acid concentrate pump 526 and the bicarbonate pump 532, and are configured to receive and mix a combined flow of heated water, acid concentrate, and bicarbonate to produce a homogeneous dialysate fluid. Figure 5 As shown, mixing chambers 534 and 536 are arranged in series to ensure thorough mixing of the dialysate solution.

[0084] The balancing devices 554 and 556 are fluidly connected to downstream fluid lines of the mixing chambers 534 and 536. The balancing devices 554 and 556 each include a spherical chamber divided into a first half-chamber 558 and 560 and a second half-chamber 562 and 564 respectively by flexible membranes 566 and 568. When fluid flows into the first half-chamber 558 and 560, fluid is forced out of the second half-chamber 562 and 564, and vice versa. Valves 538-552 control the inflow and outflow of dialysate into the balancing devices 554 and 556, such that when fresh dialysate flows into one balancing device 554, used dialysate flows into the other balancing device 556, and vice versa. For example, when used dialysate flows into the second half-chamber 562 of the balancing device 554 and forces fresh dialysate out of the first half-chamber 558 of the balancing device 554 towards the dialyzer 110, fresh dialysate flows into the first half-chamber 560 of the balancing device 556 and forces used dialysate out of the second half-chamber 564 of the balancing device 556 towards the discharge system, and vice versa. This alternation of fresh and used dialysate flowing into the balancing devices 554 and 556 is controlled by valves 538-552. This balancing device configuration and the alternating flow of fresh and used dialysate help ensure that the volume of fluid entering the balancing devices 554 and 556 is equal to the volume of fluid leaving the balancing devices 554 and 556. This helps ensure that, when needed during treatment, the volume of fresh dialysate entering the dialysate circuit is equal to the volume of used dialysate leaving the dialysate circuit, as described in more detail below.

[0085] During hemodialysis, fresh dialysate, after passing through the first half-chambers 558 and 560 of balancing devices 554 and 556, is directed to dialyzer 110 via dialysate filter 574. Before being filtered by dialysate filter 574, the fresh dialysate flows downstream of balancing devices 554 and 556 through a conductivity cell 570 and a temperature monitoring thermistor 572. The conductivity cell 570 and the temperature monitoring thermistor 572 regulate the temperature of the fresh dialysate entering filter 574 and dialyzer 110. Fresh dialysate exiting balancing devices 554 and 556 flows along a fluid line through dialysate filter 574, which is configured to filter the fresh dialysate received from balancing devices 554 and 556 before supplying dialysate to dialyzer 110. An example of such a dialysate filter 574 is available from Fresenius Healthcare Filters. Dialysis fluid filter. During hemodialysis, bypass valve 575 is closed and dialyzer inlet valve 576 is opened to direct dialysate flow from dialysate filter 574 to dialyzer 110.

[0086] During hemodialysis, fresh dialysate flowing from the first half-chambers 558, 560 of the balancing devices 554, 556 is directed through dialyzer 110 to the air separation chamber 593. Used dialysate exits dialyzer 110 along the drain line 112 of the dialysate circuit 500. A pressure sensor 586, positioned along the drain line 112 connecting dialyzer 110 to the air separation chamber 593, is adapted to measure the pressure of the used dialysate exiting dialyzer 110. Any of various types of pressure sensors capable of measuring the pressure of the used dialysate from dialyzer 110 to the air separation chamber 593 can be used.

[0087] Used dialysate exiting dialyzer 110 is collected in air separation chamber 593. Air separation chamber 593 uses an air sensor coupled to it to detect air contained in the used dialysate, and air separation chamber 593 expels any air contained in the used dialysate. Air detected in the used dialysate by the balancing chamber travels to the exhaust system through exhaust valve 594.

[0088] The dialysate flow pump 595 is configured to pump used dialysate from the air separation chamber 593 through a fluid line to the second half-chambers 562, 564 of the balancing devices 554, 556. As previously described, the flow of used dialysate into the balancing devices 554, 556 is controlled by valves 540 and 544 to alternate the flow of used dialysate between each of the second half-chambers 562, 564 of the balancing devices 554, 556.

[0089] When one of the second half-chambers 562 and 564 of one of the balancing devices 554 and 556 is filled with used dialysate, the fresh dialysate in the first half-chambers 558 and 560 of the corresponding balancing devices 554 and 556 is discharged into the dialyzer 110. Subsequently, when the first half-chambers 558 and 560 of the corresponding balancing devices 554 and 556 are refilled with fresh dialysate, the used dialysate is forced out of the second half-chambers 562 and 564 of the corresponding balancing devices 554 and 556 through one of the valves 548 and 552, respectively, and reaches the discharge system via the discharge line 112. As described above, when fresh dialysate flows into one balancing device 554, used dialysate flows into the other balancing device 556, and vice versa.

[0090] like Figure 5As shown, ultrafiltration line 591 is connected to the outlet of air separation chamber 593. Ultrafiltration pump 597 is operatively connected to ultrafiltration line 591 such that when ultrafiltration pump 597 is operating, used dialysate can be drawn from air separation chamber 593 and guided to the discharge system via ultrafiltration line 591. Operating ultrafiltration pump 597 simultaneously with dialysate flow pump 595 increases the vacuum pressure within the line connecting air separation chamber 593 to dialyzer 110, thereby creating an increased vacuum pressure within dialyzer 110. Due to this increased vacuum pressure, additional fluid is drawn from the blood circuit across the semi-permeable structure (e.g., a semi-permeable membrane or semi-permeable microtube) of dialyzer 110 into the dialysate circuit. Therefore, ultrafiltration pump 597 can be operated to remove excess fluid from the patient.

[0091] like Figure 5 As shown, the inlet line 210 of the discharge device is connected to the fluid line of the dialysate circuit downstream of the dialysate filter 574 and upstream of the dialyzer 110. The dialyzer inlet valve 576, which runs downstream of the dialysate filter 574, can be closed to direct the fluid flow leaving the dialysate filter 574 to the inlet line 210 and chamber 208 of the discharge device 200.

[0092] Still referencing Figure 5 The output line 212 of the discharge device 200 is coupled downstream of the discharge valve 589 of the discharge line 112. As previously described, the discharge device output valve 216 is positioned along the output line 212. When the discharge device output valve 216 is closed, fluid supplied to the chamber 208 via the input line 210 is collected in the chamber 208 of the discharge device 200. In some examples, fluid is continuously supplied to the discharge device 200 from the fluid line of the dialysate circuit 500 via the input line 210 until a pressure sensor 240 positioned along the output line 212 detects pressure in the chamber 208 of the discharge device 200, indicating that the chamber 208 is full of fluid. Opening the valve 216 allows the fluid collected in the chamber 208 of the discharge device 200 to flow through the output line 212 to the discharge line 112. For example, after a predetermined amount of time has been allowed for the heated disinfectant fluid supplied to chamber 208 via inlet line 210 to remain in chamber 208, valve 216 can be opened to discharge the disinfectant fluid from chamber 208 to outlet line 112. An outlet device pump 214, positioned along outlet line 212, can also be used to pump fluid from chamber 208 of outlet device 200 to outlet line 112 via outlet line 212.

[0093] The various fluid lines and discharge lines 112, as well as the input lines 210 and output lines 212 of the dialysate circuit 500, can be formed from any of a variety of different medical-grade materials. Examples of such materials include PVC, polyethylene, polypropylene, silicone, polyurethane, high-density polyethylene, nylon, ABS, acrylic, Isoplast, polyisoprene, and polycarbonate.

[0094] Figure 6 This is a schematic diagram illustrating the flow path of fluid entering, passing through, and exiting the blood circuit 600 of the hemodialysis system 100. During hemodialysis treatment, one end 628 of the arterial patient line 106 is fluidly connected to the artery of the patient 602. The arterial patient line 106 is also fluidly connected to an arterial pressure sensor 604. The arterial pressure sensor 604 is fluidly connected to the arterial patient line 106 and is configured to measure the pressure of the blood flowing through the arterial patient line 106. Figure 6 As shown, arterial pressure sensor 604 is positioned upstream of blood pump 116 to measure pre-pump arterial pressure. When it detects that the pressure within blood circuit 600 has dropped below a certain level, arterial pressure sensor 604 can transmit a signal of this effect to hemodialysis machine 102, which can activate audio and / or visual alarms to alert the system operator of the drop in patient 602's blood pressure. In some embodiments, arterial pressure sensor 604 is provided as a combination of a pressure transducer aligned with a pressure sensor diaphragm. For example, the pressure transducer can be positioned on door 140 of module 114 such that when door 140 is closed, the pressure sensor presses against the pressure diaphragm and can measure the pressure of the blood flowing through the diaphragm. For example, when the fluid pressure within the pressure sensor diaphragm changes, the amount of pressure applied to the pressure transducer by the pressure sensor diaphragm also changes.

[0095] Arterial patient line 106 extends from patient 602 to a first pump line adapter 618 that connects one end of arterial patient line 106 to a U-shaped pump line 620. The other end of pump line 620 is connected to a second pump line adapter 622 that provides fluid connection to dialyzer inlet line 134. Dialyzer inlet line 134 is connected via a tube adapter to blood inlet port 624 of dialyzer 110. Blood outlet port 626 of dialyzer 110 is connected to another tube adapter that connects dialyzer 110 to dialyzer outlet line 136. Blood pump 116 pumps blood from the artery of patient 602 through arterial patient line 106 to dialyzer 110.

[0096] A venous pressure sensor 606 is positioned upstream of the air release device 608 along the dialyzer output line 136 and is configured to monitor blood pressure on the venous side of the dialyzer 110. In some embodiments, the venous pressure sensor 606 is provided as a combination of a pressure transducer aligned with a pressure sensor capsule. For example, the pressure transducer may be positioned on a door 140 of module 114 such that when the door 140 is closed, the pressure transducer presses against the pressure capsule and can measure the pressure of the blood flowing through the capsule. For example, when the fluid pressure within the pressure sensor capsule changes, the amount of pressure applied to the pressure transducer by the pressure sensor capsule also changes.

[0097] like Figure 6 As shown, the dialyzer output line 136 is coupled to an air release device 608. The air release device 608 includes an exhaust assembly 610 located at the top of the air release device 608. The exhaust assembly 610 allows air to pass through while inhibiting (e.g., preventing) the passage of fluid. If the blood passing through the blood circuit 600 during treatment contains air, the air will be released into the atmosphere as the blood passes through the air release device 608.

[0098] In some embodiments, module 114 of the hemodialysis machine 102 includes a level detector 612, which is aligned with an air release device 608 when the blood component assembly 104 is attached to the front of module 114. The level detector 612 is adapted to detect the level of liquid (e.g., blood and / or saline) within the air release device 608.

[0099] Still referencing Figure 6 The intravenous patient line 108 is connected at the first end to the exit port of the air release device 608 and is fluidly connected at the second end 630 to the vein of the patient 602 during treatment.

[0100] A bubble detector 632 is positioned downstream of the air release device 608 along the intravenous patient line 108. The bubble detector 632 is capable of detecting air bubbles within the intravenous patient line 108. The bubble detector 632 includes a housing forming a channel for receiving the intravenous patient line 108. In some embodiments, the door 140 of the module 114 of the hemodialysis machine 102 includes flaps that, when the door 140 is closed, press the intravenous patient line 108 into the channel of the housing and abut against the sensor of the bubble detector 632.

[0101] Occluder 634 is positioned downstream of bubble detector 632 along intravenous patient line 108. Occluder 634 is configured to be able to coil a portion of intravenous patient line 108 disposed therein when activated to prevent blood from flowing through intravenous patient line 108. For example, occluder 634 may be connected to bubble detector 632 such that occluder 634 can be activated when bubble detector 632 detects air bubbles within intravenous patient line 108. Such arrangement helps ensure that no air bubbles reach the patient if air release device 608 fails to remove one or more air bubbles from the blood. Similar to bubble detector 632, occluder 634 includes a housing forming a channel for receiving intravenous patient line 108. In some embodiments, door 140 of module 114 includes flaps that press intravenous patient line 108 into the channel of housing of occluder 634 when door 140 is closed.

[0102] In addition to the blood lines forming the main blood circuit 600, a saline delivery line 126 and a drug delivery line 128 can be connected to the blood lines 600 to introduce saline and a drug (e.g., heparin) into the blood circuit 600, respectively. Figure 6 As shown, the saline delivery line 126 is connected to the saline bag 138 at the first end and to the first pump line adapter 618 at the second end.

[0103] A drug delivery line 128 is connected at a first end to a syringe 130—which can contain medication to be administered to a patient 602—and at a second end to a second pump line adapter 622. The syringe 130 may be coupled to a drug pump 132. The drug pump 132 is a syringe pump that includes a clamping mechanism configured to hold the syringe 130 of the blood component assembly 104. The drug pump 132 also includes a stepper motor configured to move a plunger of the syringe 130 along the axis of the syringe 130. The shaft of the stepper motor is fixed to the plunger such that when the stepper motor operates in a first direction, the shaft forces the plunger into the syringe 130, and when operated in a second direction, the shaft pulls the plunger out of the syringe 130. Therefore, the drug pump 132 can be used to inject liquid drugs (e.g., heparin) from the syringe 130 into the blood circuit 600 via the drug delivery line 128 during use, or to draw liquid from the blood circuit 600 into the syringe 130 via the drug delivery line 128 during use.

[0104] Various blood delivery lines, saline delivery lines 126, and drug delivery lines 128 can be formed from any of a variety of different medical-grade materials. Examples of such materials include PVC, polyethylene, polypropylene, silicone, polyurethane, high-density polyethylene, nylon, ABS, acrylic, Isoplast, polyisoprene, and polycarbonate.

[0105] Various blood tubing, saline delivery tubing 126, and drug delivery tubing 128 are typically held within module 114. Various techniques can be used to attach the tubing to module 114. For example, a carrier body having a series of orifices and recesses for capturing and holding various blood tubing and components can be attached to module 114 of the hemodialysis machine 102. In some examples, mechanical attachment devices (e.g., clamps or grippers) can be attached to the carrier body for holding the tubing, and the carrier body can be attached to module 114 of the hemodialysis machine 102. As another example, the tubing can be adhered to or thermally bonded to the carrier body, and the carrier body can be attached to module 114 of the hemodialysis machine.

[0106] refer to Figure 5 and Figure 16 A method for preparing a hemodialysis system 100 for hemodialysis treatment will now be described. Before starting hemodialysis treatment, a blood component assembly 104 is connected to a hemodialysis machine 102, such as... Figure 1 As shown. For example, the first end of the arterial patient line 106 is attached to the pump line 620 via a first pump line adapter 618, and the first end of the venous patient line 108 is attached to the exit port of the air release device 608. Furthermore, as... Figure 16 As shown, prior to the perfusion hemodialysis system 100, the patient end 628 of the arterial patient line 106 is coupled to the saline bag 138 via the saline delivery line 126, and the patient end 630 of the venous patient line 108 is attached to the discharge device 200 using the discharge device clip 226. By attaching the venous patient line 108 to the discharge device 200 using the clip 226, the patient end 630 of the venous patient line 108 can be positioned within the chamber 208 of the discharge device 200 without contacting the wall of the inner funnel 218 of the discharge device 200.

[0107] To initiate the perfusion system 100, saline solution is introduced into the blood circuit 600 from the saline bag 138 via the arterial patient line 106. To draw saline solution from the saline bag 138 and into the blood circuit 600 via the arterial patient line 106, the blood pump 116 is activated. The blood pump 116 draws saline solution from the saline bag 138, through the saline delivery line 126 and the arterial patient line 106, through the arterial pressure sensor 604, and through the pump line 620 to the dialyzer 110. The saline solution flows into the dialyzer 110 via the dialyzer inlet line 134 and exits the dialyzer 110 via the dialyzer outlet line 136. As the saline solution flows through the dialyzer outlet line 136 towards the air release device 608, it passes through the venous pressure sensor 606.

[0108] Next, saline solution flows through the inlet port of air release device 608 and fills air release device 608. To fill air release device 608, the intravenous patient line 108 leading from air release device 608 is clamped, while saline solution is forced into air release device 608. When the air release device is full of saline solution, air is forced out of the top of air release device 608 and through venting assembly 610. Because the intravenous patient line 108 is still clamped at this time, the operation of blood pump 116 establishes a large pressure within blood air release device 608 via venting assembly 610. Saline solution does not pass through venting assembly 610 because the membrane of venting assembly 610 is hydrophobic.

[0109] Once the air release device 608 is filled with saline, the clamp is removed from the intravenous patient line 108, and the saline flows through the intravenous patient line 108 to the patient end 630 of the intravenous patient line 108. Once the entire blood circuit 600 is filled with saline, any additional (e.g., excess) saline pumped through the blood component assembly 104 exits the patient end 630 of the intravenous patient line 108 and is captured by the chamber 208 of the discharge device 200. During perfusion, the discharge device output valve 216, fluidly connected to the output line 212 of the discharge device 200, opens, and the discharge device pump 214 opens to draw the saline collected by the discharge device 200 from the intravenous patient line 108 through the output line 212 to the discharge line 112.

[0110] The perfusion process described above is used to remove air from the blood circuit 600 and to fill the blood circuit 600 with saline solution from the patient end 628 of the arterial patient line 106 to the patient end 630 of the venous patient line 108. Once all air has been expelled from the patient lines 106 and 108 and the blood circuit 600 is filled with saline solution, clamps are closed on the patient ends 628 and 630 of the patient lines 106 and 108. Once clamped, the patient end 628 of the arterial patient line 106 is removed from the saline bag 138, and the patient end 630 of the venous patient line 108 is removed from the discharge device 200.

[0111] After initial perfusion, the patient ends 628 and 630 of patient lines 106 and 108 can be connected together using a sterile recirculation connector, and the saline solution contained in the blood circuit 600 can be recirculated away from the discharge device 200 through the blood circuit 600 until the patient 602 is ready to receive treatment.

[0112] Once blood circuit 600 has been perfused and patient 602 is ready to receive treatment, such as Figure 6As shown, the patient ends 628 and 630 of the arterial and venous patient lines 106 and 108 are connected to patient 602, and hemodialysis is initiated. (Reference) Figure 5 and 6 The method of performing dialysis treatment using the hemodialysis system 100 will now be described.

[0113] During hemodialysis, blood circulates through the blood circuit (i.e., the various blood lines and blood components of the blood component assembly 104, including the dialyzer 110). Simultaneously, dialysate circulates through the dialysate circuit (i.e., the various fluid lines and dialysate components, including the dialyzer 110).

[0114] like Figure 5 As shown, the dialysate is generated by the dialysate circuit 500 and supplied to the dialyzer 110 via the fluid lines of the dialysate circuit 500. For example, refer to Figure 5 During hemodialysis, recirculation valve 508 is closed and water inlet valve 510 is open, allowing water for generating dialysate to be received by hydraulic circuit 500 through water inlet port 502. The water passes through heat exchanger 506, the open water inlet valve 510, and enters deaeration and heating chamber 512. In some embodiments, if the water temperature detected by temperature control thermistor 514 in heating sub-chamber 512A is below a threshold temperature, heater 516 in heating sub-chamber 512B can be used to heat the water to above the threshold temperature. The heated water is deaerated by passing through aeration holes 518 positioned between sub-chambers 512C and 512D.

[0115] During hemodialysis, degassing pump 520 pumps heated and degassed water through fluid lines from degassing and heating chamber 512 to mixing chambers 534 and 536. The heated and degassed water flow is combined with an acid concentrate flow provided by acid concentrate pump 526 and a bicarbonate flow provided by bicarbonate pump 532. Figure 5 As shown, the acid concentrate can be filtered by the acid concentrate filter 524 before being introduced into the heated water stream. Similarly, the bicarbonate supplied by the bicarbonate pump 532 can be filtered by the bicarbonate filter 530 before being introduced into the heated water stream. Mixing chambers 534 and 536 receive the combined flow of heated water, acid concentrate, and bicarbonate and mix these fluids to generate a homogeneous dialysate fluid.

[0116] As previously described, the dialysate flows from the mixing chamber 536 to the first half-chambers 558 and 560 of one of the balancing devices 554 and 556, respectively controlled by valves 538 and 542. As previously described, when fresh dialysate flows into one balancing device 554, used dialysate flows into the other balancing device 556, and vice versa. When fresh dialysate flows into the first half-chambers 558 and 560, used dialysate is forced out of the corresponding second half-chambers 562 and 564 via the discharge line 112 through valves 548 and 552. Furthermore, when used dialysate flows from the dialyzer 110 into the second half-chambers 562 and 564 via the air separation chamber 593, fresh dialysate in the corresponding first half-chambers 558 and 560 is forced out of the corresponding balancing devices 554 and 556 via valves 546 and 550 and flows into the dialyzer 110.

[0117] Before the dialysate generated by the dialysate circuit 500 is supplied to the dialyzer 110, the dialysate passes through a dialysate filter 574 to remove any potential impurities. During hemodialysis, a bypass valve 575 is closed and a dialyzer inlet valve 576 is opened to guide the dialysate from the dialysate filter 574 to the dialyzer 110, and the dialysate flows from the dialysate filter 574 to the dialyzer 110. Additionally, during hemodialysis, the discharge device inlet valve 242 is closed to prevent dialysate from flowing into the discharge device during dialysis. If, during hemodialysis, the pressure sensor 240 detects fluid buildup in the discharge device 200 for any reason (e.g., a malfunction of valve 242), valve 216 can be opened to empty the discharge device without interrupting hemodialysis. In some embodiments, the dialysate flows past a dialysate flow line indicator 578 before entering the dialyzer 110.

[0118] During hemodialysis, used dialysate leaves the dialyzer 110 and passes through the dialysate circuit via the discharge line 112. For example... Figure 5 As shown, during hemodialysis, dialyzer output valve 584 opens and receives used dialysate from dialyzer 110 via discharge line 112. The used dialysate passes through fluid line filter 582 and dialyzer output valve 584. Fluid line filter 582 filters the used dialysate leaving dialyzer 110. The used dialysate leaving dialyzer 110 passes through pressure sensor 586, configured to measure the pressure of the dialysate entering discharge line 112 from dialyzer 110, and through blood leak detector 588, configured to detect whether blood has leaked into the dialysate through the dialyzer 110 membrane.

[0119] Before entering the air separation chamber 593, the used dialysate flows through the dialyzer post-temperature thermistor 590 and the dialyzer post-conductivity cell 592, which is configured to regulate the temperature of the used dialysate.

[0120] As previously described, used dialysate is received by an air separation chamber 593, which is configured to discharge any air contained in the dialysate via a valve 594. A dialysate flow pump 595 draws dialysate from the air separation chamber 593, through a discharge check valve 596, and through one of valves 540 and 544 into one of the second half-chambers 562 and 564 of the balancing devices 554 and 556, respectively. The discharge check valve 596 is fluidly coupled to a discharge line 112 downstream of the dialysate flow pump 595 and is configured to prevent backflow of fluid along the discharge line 112 toward the dialysate flow pump 595.

[0121] When fresh dialysate is supplied to one of the first half-chambers 558 and 560 of the balancing devices 554 and 556, the used dialysate in the corresponding second half-chamber is forced to flow out from the corresponding balancing device 554 and 556 to the heat exchanger 506 along the discharge line 112.

[0122] During hemodialysis, the ultrafiltration pump 597 operates simultaneously with the dialysate flow pump 595 to generate an increased vacuum pressure within the drain line 112 that connects the air separation chamber 593 to the dialyzer 110, thereby creating an increased vacuum pressure within the dialyzer 110. Due to this increased vacuum pressure, additional fluid is drawn from the blood circuit 600 through a semi-permeable structure (e.g., a semi-permeable membrane or semi-permeable microtube) of the dialyzer 110 into the dialysate circuit 500. This additional fluid travels along the drain line 112 through the ultrafiltration pump filter 598 downstream of the air separation chamber 593 and through the ultrafiltration check valve 599, reaching the drain line 112 and the heater. The ultrafiltration check valve 599 prevents fluid from flowing back along the ultrafiltration line 591 toward the ultrafiltration pump 597.

[0123] After passing through the heat exchanger 506, the used dialysate leaves the dialysate circuit through the discharge line 112 and proceeds to the discharge system outside the hemodialysis machine 102.

[0124] refer to Figure 6 During hemodialysis, blood from patient 602 is drawn from the patient end 628 of arterial patient line 106 into blood circuit 600 via blood pump 116. In some embodiments, before the blood from patient 602 is supplied to dialyzer 110, the blood flow is combined with saline solution supplied by saline delivery line 126 and one or more drugs (e.g., heparin) supplied by drug pump 132 via drug delivery line 128 from syringe 130. The combined flow enters dialyzer 110 through dialyzer inlet line 134.

[0125] After passing through dialyzer 110, the filtered blood of patient 602 leaves dialyzer 110 and enters blood circuit 600 through dialyzer output line 136. The blood flows through venous pressure sensor 606 to air release device 608. As previously described, air release device 608 removes any air contained in the filtered blood through exhaust assembly 610.

[0126] After flowing through the air release device 608, the degassed, filtered blood flows through the intravenous patient line 108 to the bubble detector 632. As previously described, the bubble detector is configured to detect air bubbles contained in the blood flow. After passing through the bubble detector 632, the filtered blood passes through the occluder 634. As previously described, the occluder 634 can be connected, for example, to the bubble detector 632 such that the occluder 634 can be activated when the bubble detector 632 detects air bubbles within the intravenous patient line 108. If the bubble detector 632 does not detect air bubbles, the blood flows through the occluder 634 to the patient end 630 of the intravenous patient line 108 and enters the patient's body.

[0127] After dialysis treatment has been performed, the blood contained in the blood circuit 600 is re-infused (i.e., flushed back) to the patient 602. To perform the re-infusion, the arterial patient line 106 is clamped, and the patient end 628 of the arterial patient line 106 is attached to a saline bag 138. The arterial patient line 106 is then released, and saline solution is pumped from the saline bag 138 through the arterial patient line 106 via a blood pump 116. The saline solution is then pumped through the entire blood circuit 600 to the patient end 630 of the venous patient line 108 to push any remaining blood in the blood circuit 600 back to the patient 602 and fill the blood circuit 600 with saline solution.

[0128] Once the desired amount of blood contained in the blood circuit 600 has been reinfused back into the patient 602, patient lines 106 and 108 are clamped and intravenous patient line 108 is removed from the patient 602. Figure 16As shown, the patient end 630 of the intravenous patient line 108 is attached to the discharge device 200 using a clip 226. By attaching the intravenous patient line 108 to the discharge device 200 using the clip 226, the patient end 630 of the intravenous patient line 108 is positioned within the chamber 208 of the discharge device 200 without contacting the wall of the inner funnel 218. A blood pump 116 draws saline solution from the saline bag 138 through the arterial patient line 106 and circulates the saline solution through all components of the blood circuit 600. After circulating through the blood circuit 600, the saline solution exits the patient end 630 of the intravenous patient line 108 and is collected in the chamber 208 of the discharge device 200. The discharge device output valve 216 opens and the discharge device pump 214 opens to draw the saline solution collected by the discharge device 200 from the intravenous patient line 108 through the output line 212 to the discharge line 112. Normal saline is continuously pumped through the blood circuit 600 until all remaining patient fluid has been flushed from the blood circuit 600 into the discharge device 200. In some cases, for example, normal saline is pumped through the blood circuit 600 until the normal saline bag 138 is empty.

[0129] After completing the patient's treatment and flushing the blood circuit 600, the blood component assembly 104 is disconnected from module 114 of the hemodialysis machine 102 and discarded. Dialysis fluid contained in the dialysate circuit is pumped via drain line 112 to the drain system outside the hemodialysis machine using dialysate flow pump 595 and / or ultrafiltration pump 597. After treatment, the dialysate circuit and drain equipment are sterilized in preparation for subsequent treatments.

[0130] refer to Figure 2 and 5 The method for sterilizing the dialysate circuit 500 and the discharge device 200 will now be described. As previously mentioned, after dialysis treatment is completed and the blood circuit 600 is flushed, the intravenous patient line 108 is removed from the discharge device 200 and discarded along with the remainder of the blood component assembly 104. In some embodiments, during sterilization, one or more of the acid concentrate port 522 and bicarbonate port 528 of the dialysate circuit are removed from the acid concentrate source and bicarbonate source and connected to a chemical disinfectant fluid concentrate source. Before sterilizing the dialysate circuit 500 and the discharge device 200, the cap 202 of the discharge device 200 is closed to form a liquid-tight seal with the chamber 208 of the discharge device 200, and the discharge device output valve 216 on the output line 212 is closed.

[0131] Once the drain cover 202 is closed and the drain outlet valve 216 is closed, sterilization of the dialysate circuit 500 and the drain outlet 200 can begin. To sterilize the dialysate circuit 500 and the drain outlet 200, water is pumped from the water inlet port 502 into the dialysate circuit 500 and then into the heat exchanger 506.

[0132] Water heated by heat exchanger 506 flows from heat exchanger 506 through recirculation valve 508 to degassing and heating chamber 512. Degassing and heating chamber 512 is configured to heat and degas water received by dialysate circuit 500 through water inlet port 502 for disinfection. The water is heated to the desired temperature in degassing and heating chamber 512.

[0133] One or more of the acid concentrate pump 526 and bicarbonate pump 532 pump the chemical disinfectant concentrate into a heated water stream exiting the degassing and heating chamber 512. The combined stream of heated water and chemical disinfectant concentrate is supplied to mixing chambers 534, 536 to mix the heated water and disinfectant concentrate to form a homogeneous disinfectant fluid.

[0134] The disinfectant fluid exits the mixing chamber 536 and flows through valves 538 and 542 to one of the first half-chambers 558 and 560 of one of the balancing devices 554 and 556. Similar to the flow of the dialysate solution, when the disinfectant fluid flows through the first half-chamber 558 of one balancing device 554, the disinfectant fluid flows into the second half-chamber 564 of the other balancing device 556, and vice versa, controlled by valves 538-552. Furthermore, similar to the flow of the dialysate solution, when the disinfectant fluid flows into the first half-chambers 558 and 560 of the balancing devices 554 and 556, the disinfectant fluid is simultaneously forced out of the second half-chambers 562 and 564, and vice versa.

[0135] The disinfectant fluid flowing out of the first half-chambers 558 and 560 of the balancing devices 554 and 556 flows through the conductivity cell 570 and the temperature monitoring thermistor 572 to the dialysate filter 574. During the initial flow of the disinfectant fluid through the dialysate circuit 500, the bypass valve 575 opens and the discharge device inlet valve 242 and the exhaust valve 594 close to direct the disinfectant fluid from the dialysate filter 574 to the post-dialyzer temperature thermistor 590 and the post-dialyzer conductivity cell 592, and through the air separation chamber 593.

[0136] Then, one or more of the dialysate flow pump 595 and ultrafiltration pump 597 pump disinfectant fluid from air separation chamber 593 to one of the second half-chambers 562 and 564 of one of the balancing devices 554 and 556 via valves 540 and 544, respectively. While the disinfectant fluid flows into the first half-chambers 558 and 560, the disinfectant fluid in the second half-chambers 562 and 564 flows out of the second half-chambers 562 and 564 via discharge line 112 through valves 548 and 552, respectively. During disinfection, discharge valve 589 is closed, and the disinfectant fluid leaving the second half-chambers 562 and 564 flows through discharge line 112 to heat exchanger 506, and then returns via fluid line through recirculation valve 508.

[0137] Water is continuously added to the dialysate circuit 500 via water inlet port 502 to generate disinfectant fluid for circulation throughout the dialysate circuit 500. During disinfection, water inlet pressure regulator 504 monitors the fluid pressure in the fluid line extending from water inlet port 502, and whenever water inlet pressure regulator 504 detects that a threshold pressure indicating the entire dialysate circuit is filled with disinfectant fluid has been reached, bypass valve 575 closes and discharge device inlet valve 242 opens. By closing bypass valve 575 and opening discharge device inlet valve 242, disinfectant fluid leaving dialysate filter 574 is directed to discharge device 200 via inlet line 210 coupled to the outlet of dialysate filter 574.

[0138] Still referencing Figure 2 and 5 The disinfectant fluid flows through the open inlet valve 242 and inlet line 210 to the inlet port 204 of the outlet device 200, and flows upward to fill the annular channel 228 between the inner funnel 218 and the outer funnel 220. Once the disinfectant fluid reaches the top of the annular channel 228, the curved upper lip 222 of the outer funnel 220 forces the solution over the annular surface 224 of the inner funnel 218, causing the disinfectant fluid to flow down the surface of the inner funnel 218. Because the annular channel 228 completely surrounds the inner funnel, the disinfectant fluid is evenly distributed on the surface of the inner funnel 218 and cleans the entire surface of the inner funnel 218.

[0139] During this portion of the disinfection process, the discharge device output valve 216 is closed to allow the chamber 208 of the discharge device 200 to fill with disinfectant fluid. Additionally, during this portion of the disinfection process, the pump 214 is positioned to prevent disinfectant fluid from flowing through the output line 212 to the discharge line 112, thus allowing the chamber 208 of the discharge device 200 to fill with disinfectant fluid. As the disinfectant fluid enters the chamber 208 of the discharge device 200 via the inlet line 210 and the annular channel 228, the chamber 208 begins to fill with disinfectant fluid, and any air in the chamber 208 is discharged from the vent 230 and the hydrophobic filter 232, which are coupled to the closed cover 202 of the discharge device 200. The hydrophobic filter 232, attached to and covering the vent 230, prevents disinfectant fluid from passing through the vent 230. This arrangement of the exhaust port 230 and the hydrophobic filter 232 allows virtually all the air in the chamber 208 to be replaced by the disinfectant fluid, thereby allowing almost the entire chamber 208 of the discharge device 200 to be filled with the disinfectant fluid when the output valve 216 is closed.

[0140] A pressure sensor 240, coupled to the output line 212 of the discharge device 200, monitors the fluid pressure in chamber 208 during disinfection. Once the pressure sensor 240 detects that the pressure in chamber 208 has reached the threshold pressure indicating that chamber 208 is full of fluid, the discharge device inlet valve 242 is closed to prevent any additional disinfectant fluid from entering chamber 208 via inlet line 210. In some embodiments, once the pressure sensor 240 detects that the pressure in chamber 208 has reached the threshold pressure indicating that chamber 208 is full of fluid, it sends a signal to close water inlet valve 510 to prevent additional water from being added to dialysate circuit 500 via water inlet port 502 and to stop the generation of disinfectant fluid.

[0141] Once chamber 208 is filled with disinfectant fluid, discharge device outlet valve 216 remains closed for a predetermined amount of time to allow the disinfectant fluid to remain in chamber 208 for the predetermined amount of time. In some embodiments, the disinfectant fluid remains in chamber 208 for at least 10 minutes (e.g., at least 30 minutes, 10 to 60 minutes).

[0142] After the disinfectant fluid has resided in chamber 208 for a predetermined amount of time, the discharge device output valve 216 opens. The discharge device pump 214 draws the disinfectant fluid from chamber 208 to discharge line 112 via output port 206 and the opened discharge device output valve 216 through output line 212. The discharge device pump 214 continues to operate until all the disinfectant fluid has been pumped from the discharge device 200 to discharge line 112.

[0143] Similarly, once the disinfectant fluid has been recirculated through the dialysate circuit for a predetermined amount of time, the recirculation valve 508 closes and the discharge valve 589 opens to allow the disinfectant fluid to be directed through the discharge line 112 to the discharge system. In some embodiments, the dialysate flow circuit pumps the disinfectant fluid through balancing devices 554, 556 and along the discharge line 112 through the discharge valve 589. In some embodiments, the discharge valve 589 and the discharge device output valve 216 open simultaneously or nearly simultaneously, and the dialysate circuit 500 and the discharge device 200 discharge the disinfectant fluid simultaneously.

[0144] While some embodiments have been described above, other embodiments are also possible.

[0145] For example, Figure 7 This is a schematic diagram showing an alternative arrangement of the dialysate circuit 500 and the discharge device 200 of the hemodialysis machine 102. (See diagram below.) Figure 7 As shown, the discharge device 200 does not include a discharge device pump (e.g., along the output line 212 between the output port 206 of the discharge device 200 and the discharge line 112). Figure 2-5 (Discharge device pump 214). In this case, the discharge device 200 is configured such that whenever the discharge device valve 216 is opened, the fluid contained in the chamber 208 of the discharge device 200 is discharged by gravity to the discharge line 112 via the output line 212. For example, during the disinfection of the discharge device 200, whenever the discharge device output valve 216 is opened, the disinfectant fluid contained in the chamber 208 of the discharge device 200 is discharged by gravity to the discharge line 112 via the output line 212.

[0146] In some embodiments, the discharge device includes a discharge pump (e.g., discharge pump 214) along the discharge line 212, but does not include a discharge valve (e.g., along the discharge line 212 between the output port 206 of the discharge device 200 and the discharge line 112). Figure 2-5 (e.g., discharge valve 216 of 7). In this case, discharge pump 214 is used to control the flow of fluid out of chamber 208 via output line 212. For example, during sterilization of discharge device 200, discharge pump 214 can be configured to prevent fluid from flowing through output line 212 to the discharge system until discharge pump 214 is activated to pump fluid from chamber 208 to discharge line 112 via output line 212.

[0147] Figure 8 This is a schematic diagram showing an alternative arrangement of the dialysate circuit 500 and the discharge device 200 of the hemodialysis machine 102. (See diagram below.) Figure 8As shown, the inlet line 210 of the discharge device 200 is fluidly connected to a downstream fluid line of the dialysate filter 574, and the outlet line 212 of the discharge device 200 is fluidly connected to a portion of the outlet line 112 of the dialysate circuit 500 upstream of the dialysate flow pump 595. In this arrangement, as... Figure 8 As shown, the discharge device 200 does not include a discharge device pump (e.g., along the discharge line 212) Figure 2-5 Instead of the discharge device pump 214, the negative pressure generated by the dialysate flow pump 595 of the dialysate circuit 500 is used to extract the fluid contained in the chamber 208 of the discharge device 200 from the discharge device 200 via the discharge line 212 and the discharge device output valve 216. Using this arrangement, the fluid contained in the chamber 208 of the discharge device 200 is discharged through the output line 212 and provided to the dialysate circuit 500 downstream of the air separation chamber 593. The dialysate flow pump 595 then pumps the fluid from the discharge device 200 through the discharge line 112 to one of the second half chambers 562, 564 of one of the balancing devices 554, 556 and continues to pump it to the discharge system, as described above. For example, using this arrangement during the disinfection of the discharge device 200, the discharge device output valve 216 is opened and the dialysate flow pump 595 draws the disinfectant fluid contained in the chamber 208 of the discharge device 200 through the output line 212 to a portion of the discharge line 112 of the dialysate circuit 500 downstream of the air separation chamber 593. The dialysate flow pump 595 then flows the disinfectant fluid via the discharge line 112 to one of the second half-chambers 562, 564 of one of the balancing devices 554, 556. Finally, the disinfectant fluid exits the second half-chambers 562, 564 of the balancing devices 554, 556 and flows through the discharge line 112 to the discharge system.

[0148] Similarly, in some embodiments, the output line 212 of the discharge device 200 may be fluidly connected to a portion of the discharge line 112 of the dialysate circuit 500 upstream of the ultrafiltration pump 597 of the dialysate circuit. In this arrangement, the negative pressure generated by the ultrafiltration pump 597 of the dialysate circuit 500 is used to draw fluid contained in the chamber 208 of the discharge device 200 out of the discharge device 200 via the discharge line 212 through the discharge device output valve 216. The ultrafiltration pump 597 then pumps the fluid from the discharge device 200 through the discharge line 112 to one of the second half-chambers 562, 564 of one of the balancing devices 554, 556 and continues pumping it to the discharge system, as described above.

[0149] Furthermore, although the inlet line 210 of the discharge device 200 has been described as a fluid line that is fluidly connected downstream of the dialysate filter 574, the inlet line 210 may alternatively be coupled to the fluid line of the dialysate circuit 500 at any other point upstream of the dialyzer 110.

[0150] Although the discharge device 200 is described as having an exhaust port 230 and a hydrophobic filter 232 to allow complete filling of the chamber 208 of the discharge device 200, other configurations of the discharge device may also be provided alternatively to allow complete filling of the chamber 208. Figure 9-14 Describing for Figure 1 A cross-sectional view of an alternative drainage device for a hemodialysis system.

[0151] like Figure 9 As shown, in some embodiments, the cover 902 of the discharge device may include a plurality of vents or holes 924 passing through the cover 902, instead of having a single vent and a hydrophobic filter (e.g., Figure 2 (Exhaust port 230 and hydrophobic filter 232). In this arrangement, the cover 902 of the discharge device 900 is liquid-tight when closed, and fluid contained in the chamber 208 of the discharge device can exit through the hole 924 in the cover 902. This arrangement of the hole 924 in the cover 902 of the discharge device 900 allows all air in the chamber 208 of the discharge device 900 to be displaced by disinfectant fluid during disinfection, thereby allowing the entire chamber 208 to be filled with disinfectant fluid when the output valve 216 is closed. In some embodiments, in order to fill the chamber 208 of the discharge device 900 with disinfectant fluid during disinfection, a pressure sensor 240 coupled to the output line 212 monitors the fluid pressure in the chamber 208 of the discharge device 900 during disinfection, and once the pressure sensor 240 detects that the pressure in the chamber 208 has reached a threshold pressure indicating that the chamber 208 is filled with fluid, the discharge device input valve 242 closes to prevent additional disinfectant fluid from entering the chamber 208 via the input line 210. Once chamber 208 is filled with disinfectant fluid, the disinfectant fluid is allowed to remain in chamber 208 for a predetermined amount of time. In some embodiments, once pressure sensor 240 detects that the pressure in chamber 208 has reached a threshold pressure indicating that chamber 208 is filled with fluid, a signal is sent to close water inlet valve 510 to prevent additional water from being added to dialysate circuit 500 via water inlet port 502 and to stop the generation of disinfectant fluid. After the disinfectant fluid has remained in chamber 208 for the predetermined amount of time, discharge device output valve 216 is opened and discharge device pump 214 draws disinfectant fluid from chamber 208 to discharge line 112 via output port 206 and the open discharge device output valve 216.

[0152] like Figure 10 As shown, in some embodiments, the cover 922 of the discharge device 920 is not liquid-tight when in the closed position, and the chamber 208 of the discharge device 920 is filled with disinfectant fluid during sterilization by metering the flow rate of disinfectant fluid entering the inlet line 210 of the discharge device 920 using balancing devices 554, 556 of the dialysate circuit 500. For example, once the discharge device inlet valve 242 is opened during sterilization, the amount of disinfectant fluid flowing from the balancing devices 554, 556 toward the discharge device 920 can be controlled to provide the exact amount of disinfectant fluid required to fill the fluid lines between the balancing devices 554, 556 and the inlet line 210, the inlet line 210, and the chamber 208 of the discharge device 920. In this arrangement, when the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 exits the chamber 208 around the non-liquid-tight cover 922. In some embodiments, the cover 922 of the discharge device 920 includes an vent or hole (e.g., Figure 9 (orifice 924). In some examples, each stroke of the balancing devices 554, 556 supplies 30 cc of disinfectant fluid to the discharge device 920 via the input line 210, and performs a calculated number of strokes by the balancing devices 554, 556 to provide the amount of disinfectant fluid required to fill the chamber 208 of the discharge device 920. Once the chamber 208 is filled with disinfectant fluid, the discharge device output valve 216 remains closed to allow the disinfectant fluid to remain in the chamber 208 for a predetermined amount of time. After the disinfectant fluid has remained in the chamber 208 for the predetermined amount of time, the discharge device output valve 216 is opened and the discharge device pump 214 draws the disinfectant fluid from the chamber 208 to the discharge line 112 via the output port 206 and the open discharge device output valve 216.

[0153] refer to Figure 11 In some embodiments, the cap 932 of the discharge device 930 is not liquid-tight when in the closed position, and the discharge device 930 includes an ultrasonic sensor 904 coupled to the outer funnel 220 and configured to detect the liquid level 906 within the chamber 208 of the discharge device 930. For example, during disinfection, the disinfectant fluid level in the chamber 208 of the discharge device 930 is monitored by the ultrasonic sensor 904. During disinfection, the discharge device output valve 216 is closed and disinfectant fluid is supplied to the chamber 208 of the discharge device 930 via the inlet line 210. In this arrangement, as the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 exits the chamber 208 around the non-liquid-tight cap 932. In some embodiments, the cap 932 of the discharge device 930 includes an vent or hole (e.g., Figure 9(Orifice 924). Once the ultrasonic sensor 904 detects that the disinfectant fluid level 906 is at or near the top of chamber 208, the discharge device valve 242 closes to prevent any additional disinfectant fluid from entering chamber 208 of the discharge device 930 and allows the disinfectant fluid to remain in chamber 208 for a predetermined amount of time. In some embodiments, once the ultrasonic sensor 904 detects that the liquid level 906 is at or near the top of chamber 208, causing chamber 208 to fill with fluid, a signal is sent to close the water inlet valve 510 to prevent additional water from being added to the dialysate circuit 500 via water inlet port 502 and to stop the generation of disinfectant fluid. After the disinfectant fluid has remained in chamber 208 for the predetermined amount of time, the discharge device outlet valve 216 is opened and the discharge device pump 214 draws the disinfectant fluid from chamber 208 to discharge line 112 via outlet port 206 and the open discharge device outlet valve 216 through outlet line 212.

[0154] refer to Figure 12 In some embodiments, the cap 942 of the discharge device 940 is not liquid-tight when in the closed position, and one or more electrodes 908 are positioned within the chamber 208 of the discharge device and configured to detect the level 906 of the chemical disinfectant fluid within the chamber 208 of the discharge device 940. For example, one or more electrodes 908 may be attached to the top of the inner funnel 218 of the discharge device and configured to interact with the disinfectant fluid. During disinfection, the discharge device output valve 216 is closed, and the disinfectant fluid is supplied to the chamber 208 of the discharge device 940 via the inlet line 210. In this arrangement, as the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 exits the chamber 208 around the non-liquid-tight cap 942. In some embodiments, the cap 942 of the discharge device 940 includes an vent or hole (e.g., Figure 9(Orifice 924). Once the chemical disinfectant fluid is at or near the top of chamber 208, the chemicals in the disinfectant fluid will interact with one or more electrodes 908 located near the top of chamber 208, indicating that chamber 208 is filled with disinfectant fluid. In some embodiments, once one or more electrodes 908 detect that the disinfectant fluid level 906 is at or near the top of chamber 208, the discharge device valve 242 closes to prevent any additional disinfectant fluid from entering the discharge device chamber 208 and allows the disinfectant fluid to remain in chamber 208 for a predetermined amount of time. In some embodiments, once one or more electrodes 908 detect that the disinfectant fluid level 906 is at or near the top of chamber 208, a signal is sent to close the water inlet valve 510 to prevent additional water from being added to the dialysate circuit 500 via water inlet port 502 and to stop the production of disinfectant fluid. After the disinfectant fluid has resided in chamber 208 for a predetermined amount of time, the discharge device output valve 216 is opened, and the discharge device pump 214 draws the disinfectant fluid from chamber 208 through output port 206 and the opened discharge device output valve 216 to discharge line 112. Any of a variety of suitable electrodes can be used to detect the fluid level, such as an in-line electrode with an optical groove, a conductive rod probe, etc.

[0155] like Figure 13 As shown, in some embodiments, the cover 952 of the discharge device 950 is not liquid-tight when in the closed position, and the discharge device 950 includes an ultrasonic transmitter 910 and an ultrasonic receiver 912 configured to detect the liquid level 906 within the chamber 208 of the discharge device 950. In this arrangement, when the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 is discharged around the non-liquid-tight cover 952. In some embodiments, the cover 952 of the discharge device 950 includes an vent or hole (e.g., Figure 9 Hole 924). For example Figure 13As shown, the ultrasonic transmitter 910 and ultrasonic receiver 912 can be coupled to the inner surface 914 of the cover 952 of the discharge device 950, which faces the chamber 208 of the discharge device 950 when the cover 952 is in the closed position. During disinfection, the discharge device output valve 216 is closed, the cover 952 is closed over the chamber 208, disinfectant fluid is supplied to the chamber 208 of the discharge device 950 via the inlet line 210, and the ultrasonic transmitter 910 transmits sound waves to the chamber 208 through the cover 952. The sound waves emitted by the ultrasonic transmitter 910 bounce off the surface of the liquid in the chamber 208 and are received by the ultrasonic receiver 912. Based on the intensity of the sound waves received by the ultrasonic receiver 912, the level 906 of the disinfectant fluid in the chamber 208 of the discharge device 950 can be determined. Once the ultrasonic receiver 912 receives an acoustic signal indicating that the disinfectant fluid level 906 is at or near the top of chamber 208, the discharge device valve 242 closes to prevent any additional disinfectant fluid from entering the discharge device chamber 208. In some embodiments, once the ultrasonic receiver 912 receives an acoustic signal indicating that the fluid level 906 is at or near the top of chamber 208, a signal is sent to close the water inlet valve 510 to prevent additional water from being added to the dialysate circuit 500 via the water inlet port 502 and to stop the production of disinfectant fluid. After the disinfectant fluid has resided in chamber 208 for a predetermined amount of time, the discharge device outlet valve 216 is opened and the discharge device pump 214 draws the disinfectant fluid from chamber 208 to discharge line 112 via outlet line 212 through outlet port 206 and the open discharge device outlet valve 216. Any of a variety of suitable ultrasonic transmitters and receivers can be used to detect fluid levels, such as ultrasonic gap sensors.

[0156] refer to Figure 14 In some embodiments, the cover 962 of the discharge device 960 is not liquid-tight when in the closed position, and the discharge device 960 includes a light emitter 916 and a light receiver 918 configured to detect the liquid level 906 within the chamber 208 of the discharge device 960. In this arrangement, when the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 is discharged around the non-liquid-tight cover 962. In some embodiments, the cover 962 of the discharge device 960 includes an vent or hole (e.g., Figure 9 Hole 924). For example Figure 14As shown, the light emitter 916 and the light receiver 918 can be coupled to the inner surface 964 of the cover 962 of the discharge device 960, which faces the chamber 208 of the discharge device 960 when the cover 962 is in the closed position. During disinfection, the discharge device output valve 216 is closed, the cover 962 is closed over the chamber 208, disinfectant fluid is supplied to the chamber 208 of the discharge device 960 via the inlet line 210, and the light emitter 916 transmits light waves into the chamber 208. The light waves emitted by the light emitter 916 bounce off the surface of the liquid in the chamber 208 and are received by the light receiver 918. Based on the intensity of the light waves received by the light receiver 918, the level 906 of the disinfectant fluid in the chamber 208 of the discharge device 960 can be determined. Once the light wave received by the light receiver 918 indicates that the disinfectant fluid level 906 is at or near the top of chamber 208, the discharge device valve 242 closes to prevent any additional disinfectant fluid from entering the discharge device chamber 208. In some embodiments, once the light wave received by the light receiver 918 indicates that the fluid level 906 is at or near the top of chamber 208, a signal is sent to close the water inlet valve 510 to prevent additional water from being added to the dialysate circuit 500 via the water inlet port 502 and to stop the production of disinfectant fluid. After the disinfectant fluid has resided in chamber 208 for a predetermined amount of time, the discharge device outlet valve 216 is opened and the discharge device pump 214 draws the disinfectant fluid from chamber 208 to discharge line 112 via outlet line 212 through outlet port 206 and the open discharge device outlet valve 216. Any of a variety of suitable light emitters and receivers can be used to detect fluid levels, such as optical switch sensors.

[0157] refer to Figure 15 In some embodiments, the cover 972 of the discharge device 970 is not liquid-tight when in the closed position, and the discharge device 970 includes a level sensor 974 coupled to the discharge device 970. The level sensor 974 is configured to detect the liquid level 906 within the chamber 208 of the discharge device 970. For example, during disinfection, the level of disinfectant fluid in the chamber 208 of the discharge device 970 is monitored by the level sensor 974. During disinfection, the discharge device output valve 216 is closed and disinfectant fluid is supplied to the chamber 208 of the discharge device 970 via the inlet line 210. In this arrangement, as the disinfectant fluid enters the chamber 208, an equal amount of air contained in the chamber 208 exits the chamber 208 around the non-liquid-tight cover 972. In some embodiments, the cover 972 of the discharge device 970 includes an vent or hole (e.g., Figure 9(Orifice 924). Once the level sensor 974 detects that the disinfectant fluid level 906 is at or near the top of chamber 208, the discharge device valve 242 closes to prevent any additional disinfectant fluid from entering chamber 208 of the discharge device 970 and allows the disinfectant fluid to remain in chamber 208 for a predetermined amount of time. In some embodiments, once the level sensor 974 detects that the liquid level 906 is at or near the top of chamber 208, causing chamber 208 to be filled with fluid, a signal is sent to close the water inlet valve 510 to prevent additional water from being added to the dialysate circuit 500 via water inlet port 502 and to stop the generation of disinfectant fluid. After the disinfectant fluid has remained in chamber 208 for the predetermined amount of time, the discharge device outlet valve 216 is opened and the discharge device pump 214 draws disinfectant fluid from chamber 208 to discharge line 112 via outlet port 206 and the open discharge device outlet valve 216 through outlet line 212. Any of a variety of suitable level sensors can be used, such as level switches, magnetic level switches, magnetic float sensors, pneumatic level sensors, electrode level sensors, conductivity level sensors, etc.

[0158] While the methods described above for disinfecting the discharge device 200 include allowing the disinfectant fluid to remain in the chamber 208 of the discharge device 200 for a predetermined amount of time, other techniques may be used alternatively or additionally. In some embodiments, for example, once the chamber 208 of the discharge device 200 is filled with disinfectant fluid (as determined using the methods described above), the discharge device output valve 216 is opened to allow disinfectant fluid to flow through the output line 212 to the discharge line 112, and additional disinfectant fluid is simultaneously supplied to the chamber 208 via the input line 210. In some embodiments, once the chamber 208 is filled with disinfectant fluid and the output valve 216 is open, the dialysate circuit 500 pumps disinfectant fluid into the chamber 208 via the input line 210 at a flow rate sufficient to maintain a disinfectant fluid level 906 in the chamber 208 (i.e., keeping the chamber filled with disinfectant fluid). This "continuous flow" method of draining and simultaneously filling the chamber 208 of the drain device 200 can be performed for a predetermined amount of time to ensure that the chamber 208 is properly disinfected. In some embodiments, the disinfectant fluid continuously flows through and fills the chamber 208 for at least 10 minutes (e.g., at least 30 minutes, 10 to 60 minutes). In some examples, after the disinfectant fluid has flowed and filled the chamber 208 for the predetermined amount of time, the drain device inlet valve 242 is closed and the solution contained in the chamber 208 of the drain device 200 is drained from the chamber 208 to the drain line 112 via the drain device outlet valve 216.

[0159] Furthermore, although the disinfectant fluid used to disinfect the dialysate circuit 500 and the discharge device 200 has been described as including a chemical disinfectant concentrate, the disinfectant fluid may alternatively consist only of hot water (i.e., without the addition of a chemical disinfectant concentrate). In some examples, the disinfectant fluid is heated to a temperature of at least 80°C.

[0160] Although the hydrophobic filter 232 of the discharge device 200 has been described as being disposed within the vent 230 of the discharge device, the hydrophobic filter 232 may alternatively be incorporated into the cover 952 of the discharge device 200. For example, the cover 952 may include an opening therethrough, and the hydrophobic filter 232 may be disposed within the opening in the cover 202.

[0161] Although the cover 202 has been described as being attached to the discharge device 200 using a hinge 238, alternative attachment mechanisms such as clips, threads, injection-molded attachments, magnets, etc., can be used to attach the cover 202 to the discharge device 200. In some examples, the cover 202 is attached to the discharge device 200 along a pivot axis, such that the cover 202 can pivot along the axis to cover the discharge device 200. In some embodiments, the cover 202 pivots about the axis via a stepper motor attached to the cover 202. In some embodiments, the cover 202 may not be attached to the discharge device 200 and may be placed on top of the discharge device 200 to seal the chamber 208, for example, during sterilization of the chamber.

[0162] While the above method involves attaching only the venous patient line 108 to the drainage device 200 during perfusion and subsequent treatment, the arterial patient line 106 can be additionally or alternatively attached to the drainage device 200 for perfusion and flushing of the arterial patient line 106. For example, see reference... Figure 18 Before perfusion of the hemodialysis system 100, the patient end 628 of the arterial patient line 106 and the patient end 630 of the venous patient line 108 can be attached to the discharge device 200 using the clamp 226 of the discharge device. A first end of the saline delivery line 126 can be attached to a saline bag 138, and a second end of the saline delivery line 126 can be attached to a port 702 on the arterial patient line 106. To initiate perfusion of the system 100, saline is introduced from the saline bag 138 through the saline delivery line 126 and through the port 702 on the arterial patient line 106. Saline is initially supplied to the portion of the arterial patient line 106 between the patient end 628 and the port 702.

[0163] Once the portion of the arterial patient line 106 between the patient end 628 and port 702 is filled with saline, clamp the clamp near the patient end 628 of the arterial patient line 106. Then, blood pump 116 is turned on to draw saline from saline bag 138 through saline delivery line 126 and port 702 of the arterial patient line 106, through the portion of the arterial patient line 106 between port 702 and dialyzer 110. The saline flows into dialyzer 110 via dialyzer inlet line 134 and exits dialyzer 110 via dialyzer outlet line 136.

[0164] As saline solution flows through dialyzer output line 136 to air release device 608, it passes through venous pressure sensor 606. Next, saline solution flows through the inlet port of air release device 608 and fills it. Once air release device 608 is full, the clamp on venous patient line 108 is removed, and saline solution flows through venous patient line 108 to patient end 630. Once the entire blood circuit 700 is full of saline solution, any additional (e.g., excess) saline solution pumped through blood component assembly 104 exits patient end 630 of venous patient line 108 and is captured by chamber 208 of discharge device 200. Once all air has been expelled from patient lines 106, 108 and blood circuit 700 is full of saline solution, the clamp on patient end 630 of venous patient line 108 is closed. Once clamped, patient ends 628, 630 of patient lines 106, 108 are removed from discharge device 200.

[0165] Similarly, in some embodiments, both the arterial patient line 106 and the venous patient line 108 can be attached to the drainage device 200 to flush the patient lines 106, 108 after dialysis. For example, see Reference Figure 18 Once the desired amount of blood contained in the blood circuit 700 has been reinfused back into the patient 602, patient lines 106 and 108 are clamped and removed from the patient 602, and the patient end 628 of the arterial patient line 106 and the patient end 630 of the venous patient line 108 are attached to the discharge device 200 using clamp 226. A first end of the saline delivery line 126 can be attached to a saline bag 138, and a second end of the saline delivery line 126 can be attached to a port 702 on the arterial patient line 106. Saline solution is introduced from the saline bag 138 through port 702 on the arterial patient line 106 via the saline delivery line 126.

[0166] Normal saline is first supplied to the portion of arterial patient line 106 between the patient end 628 and the port 702 on arterial patient line 106. The normal saline exits the patient end 628 of arterial patient line 106 and enters the chamber 208 of the drainage device. Normal saline is continuously supplied until all remaining patient fluid in the portion of arterial patient line 106 between the patient end 628 and the port 702 on arterial patient line 106 has been flushed into the drainage device 200.

[0167] Once the portion of arterial patient line 106 between the patient end 628 and port 702 on arterial patient line 106 has been flushed of patient fluid, the clamp near the patient end 628 of arterial patient line 106 is clamped. Then, blood pump 116 is turned on to draw saline from saline bag 138 through saline delivery line 126 and port 702 on arterial patient line 106, allowing the saline to circulate through all components of blood circuit 700. After circulation through blood circuit 700, the saline exits from patient end 630 of venous patient line 108 and collects in chamber 208 of discharge device 200. Discharge device output valve 216 is opened and discharge device pump 214 is turned on to draw the saline collected by discharge device 200 from venous patient line 108 through output line 212 to discharge line 112. Saline is continuously pumped through blood circuit 700 until all remaining patient fluid has been flushed from blood circuit 700 to discharge device 200. In some cases, such as, saline solution is pumped through the blood circuit 700 until the saline bag 138 is empty.

[0168] Although the discharge device 200 has been described as including a clamp 226 for attaching an intravenous patient line 108 to the discharge device 200, other mechanical attachment devices such as clamps, ties, straps, hooks, latches, etc., may be used alternatively or additionally for attaching patient lines 106, 108 to the discharge device. In some embodiments, the discharge device 200 includes two or more mechanical attachment devices.

[0169] Although the discharge device 200 has been described as including a coupler 234 that attaches the vent 230 to the cover 202 of the discharge device 200, in some examples, the vent is coupled to the cover without a separate coupler. For example, as Figure 17As shown, the discharge device 800 includes an exhaust port 830 with a clamping portion 832 configured to bend and fill an opening 834 in a cover 802 and couple the exhaust port 830 to the cover 802. The clamping portion 832 of the exhaust port 830 is semi-rigid and is compressed to fit into the opening 834 of the cover 802. Furthermore, once positioned within the opening 834, the clamping portion 832 of the exhaust port 830 expands to hold the exhaust port 830 in place within the opening 834. To remove the exhaust port 830 from the cover 802, a force is applied to the exhaust port 830 and the diameter of the clamping portion 832 of the exhaust port 830 is compressed, allowing the clamping portion 832 to slide out of the opening 834 of the cover 802. Once removed from the cover 802, the clamping portion 832 of the exhaust port 830 expands to its original, uncompressed diameter. In some examples, the exhaust port 830 is replaced as part of periodic maintenance. In some embodiments, a plurality of pores in the hydrophobic filter 232 close in response to contact with water, and the vent 830 is replaced after the pores in the hydrophobic filter 232 have closed.

[0170] In some examples, a leak detection sensor is positioned below the discharge device 200 (e.g., near the output port 206 of the discharge device) to detect a fault in the discharge device 200 that causes fluid to leak from the discharge device 200. The leak detection sensor may be communicatively coupled to the discharge device inlet valve 242, and the discharge device inlet valve 242 may automatically close in response to the leak detection sensor detecting fluid leakage from the discharge device 200.

[0171] Although the arterial pressure sensor 604 has been described as being positioned upstream of the blood pump 116 to measure pre-pump arterial pressure, it can alternatively be positioned downstream of the blood pump 116 to measure post-pump arterial pressure, or an additional arterial pressure sensor can be positioned downstream of the blood pump 116 to measure post-pump arterial pressure.

[0172] While the above method involves circulating saline solution through patient lines 106, 108 and blood circuit 600 to flush out any remaining patient fluid, alternatively, air can be pumped through blood circuit 600 and patient lines 106, 108 to flush out any remaining patient fluid. For example, arterial patient line 106 can be disconnected from saline delivery line 126, and blood pump 116 can be used to remove air through arterial patient line 106 via blood circuit 600.

[0173] While the above method involves using valves 538-552 to control the flow of disinfectant fluid to alternate the flow of disinfectant fluid between the first half-chambers 558, 560 and the second half-chambers 562, 564, alternatively, all balancing device valves 538-552 can be opened during the disinfection of the dialysate circuit 500. For example, during disinfection, all valves 538-552 can be opened so that the disinfectant fluid flowing from the mixing chambers 534, 536 simultaneously flows into all four half-chambers 558, 560, 562, 564.

[0174] While the above method involves allowing disinfectant fluid to flow from air separation chamber 593 into the second half-chambers 562, 564 of balancing devices 554, 556, and allowing disinfectant fluid to flow out of the second half-chambers 562, 564 through valves 548, 552, alternatively, valves 548, 552 can remain closed during disinfection, such that when disinfectant fluid flows into the first half-chamber 558 of balancing device 554, disinfectant fluid is simultaneously forced to flow out of the second half-chamber 562 of balancing device 554 and into the second half-chamber 564 of balancing device 556. Similarly, in some embodiments, when disinfectant fluid flows into the first half-chamber 560 of balancing device 556, disinfectant fluid is simultaneously forced to flow out of the second half-chamber 564 of balancing device 556 and into the second half-chamber 562 of balancing device 554.

[0175] Many embodiments have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of this disclosure. Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A dialysis system comprising: a dialysis machine including a fluid line and a drain line; a blood line set configured to be connected to the dialysis machine; a drain apparatus coupled to the dialysis machine, the drain apparatus comprising: a chamber configured to receive an end of a patient line of the blood line set; an input line having a first end couplable to the chamber and a second end couplable to the fluid line of the dialysis machine at a location downstream of a dialysate filter and upstream of a dialyzer of the dialysis machine; an output line having a first end configured to be coupled to the chamber and a second end configured to be coupled to the drain line of the dialysis machine; and a valve coupled to the output line and configured to control flow of fluid through the drain line.

2. The dialysis system of claim 1, wherein, the fluid line and the drain line are part of a hydraulic circuit of the dialysis machine, the dialysis system further comprising a dialyzer connected to the hydraulic circuit of the dialysis machine.

3. The dialysis system of claim 2, wherein, the drain line is downstream of the dialyzer.

4. The dialysis system of claim 3, wherein, the fluid line is upstream of the dialyzer.

5. The dialysis system of any one of claims 1-4, wherein, the second end of the output line is configured to be coupled to the drain line at a location upstream of a flow pump after the dialyzer of the dialysis machine.

6. The dialysis system of any one of claims 1-4, wherein, the second end of the output line is configured to be coupled to the drain line at a location of the dialysis machine downstream of a drain valve of the dialysis machine.

7. The dialysis system of any one of claims 1-4, wherein, the drain apparatus further comprises a pump coupled to the output line and configured to pump fluid from the chamber of the drain apparatus to the drain line of the dialysis machine.

8. The dialysis system of any one of claims 1-4, wherein, the drain apparatus is configured to drain fluid contained in the chamber of the drain apparatus through the output line of the drain apparatus to the drain line of the dialysis machine by gravity when the valve of the drain apparatus is in an open position.

9. The dialysis system of any one of claims 1-4, wherein, the drain apparatus further comprises a cap coupled to the chamber and configured to form a seal with the chamber.

10. The dialysis system of claim 9, wherein, the cap comprises a vent and a hydrophobic filter disposed within the vent.

11. A method comprising: emptying contents of a blood line set of a dialysis system into a chamber of a drain apparatus of the dialysis system; closing a cap of the drain apparatus to seal the chamber of the drain apparatus; flowing a sterilant fluid through an input line of the drain apparatus from a dialysis machine of the dialysis system to the drain apparatus to at least partially fill the chamber of the drain apparatus with the sterilant fluid, wherein the input line has a first end couplable to the chamber and a second end couplable to the fluid line of the dialysis machine at a location downstream of a dialysate filter and upstream of a dialyzer of the dialysis machine; and flowing the sterilant fluid through an output line of the drain apparatus from the drain apparatus to a drain line of the dialysis machine. emptying contents of a blood line set of a dialysis system into a chamber of a drain apparatus of the dialysis system comprises:

12. The method of claim 11, wherein, after performing dialysis on a patient, connecting a patient line of the blood line set to a drain apparatus of a dialysis machine; flowing a saline solution through the patient line of the blood line set into the drain apparatus to flush remaining fluid in the blood line set into the drain apparatus; and ​ The patient line of the blood line set is disconnected from the drain apparatus.

13. The method of claim 11 or 12, wherein, The method further includes stopping the flow of the disinfectant fluid upon receiving a signal from a sensor coupled to the drain apparatus indicating that a chamber of the drain apparatus is full of the disinfectant solution.

14. The method of claim 11 or 12, wherein, The disinfectant fluid resides in the chamber of the drain apparatus for a predetermined amount of time.

15. The method of claim 11 or 12, wherein, Causing disinfectant fluid to flow from the drain apparatus to a drain line of a dialysis machine through an output line of the drain apparatus includes opening a valve coupled to the output line of the drain apparatus.

16. The method of claim 11 or 12, wherein, Causing disinfectant fluid to flow from the drain apparatus to a drain line of a dialysis machine through an output line of the drain apparatus includes using a pump coupled to the output line of the drain apparatus to pump disinfectant fluid in a chamber of the drain apparatus to the drain line.

17. The method of claim 11 or 12, wherein, Causing disinfectant fluid to flow from the drain apparatus to a drain line of a dialysis machine through an output line of the drain apparatus includes using negative pressure generated by a flow pump of a dialysis machine to pump disinfectant fluid in a chamber of the drain apparatus to the drain line.

18. The method of claim 11 or 12, wherein, The disinfectant fluid includes a chemical disinfectant.

19. The method of claim 11 or 12, wherein, The disinfectant fluid is hot water.

20. The method of claim 11 or 12, wherein, Causing disinfectant fluid to flow from a dialysis machine to the drain apparatus through an input line of the drain apparatus to at least partially fill a chamber of the drain apparatus includes flowing the disinfectant fluid into the chamber at a flow rate sufficient to maintain a predetermined fluid level in the chamber for a predetermined amount of time.

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