KR20160047428A - Manifold diaphragms - Google Patents

Abstract

The present invention describes a portable dialysis device having a detachable controller unit and a base unit. The controller unit includes a door having an interior surface, a housing defining the recessed area configured to receive the interior surface of the door with the panel, and a manifold receiver fixedly attached to the panel. The manifold includes a diaphragm configured to minimize dead space and improve reactivity between the dialyzer fins. The base unit has a planar surface for receiving the fluid container, a scale integrated with the planar surface, and a heater in thermal communication with the vessel. Embodiments of the described portable dialysis system have improved structural and functional properties, including improved modularity, ease of use and safety characteristics.

Description

Manifold diaphragm {MANIFOLD DIAPHRAGMS}

Cross-reference

This application is a continuation-in-part application of co-pending U.S. Patent Application No. 13 / 023,490, entitled " Portable Dialysis Machine, " filed February 8, 2011, part.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 237,914, filed on September 25, 2008, which claims priority to U.S. Patent Application No. 60 / 975,157, filed September 25, 2007.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 610,032, filed on October 30, 2009, which claims priority to U.S. Patent Application No. 61 / 109,834, filed October 30,

The '490 application is a continuation-in-part of U.S. Provisional Patent Application No. 60 / 990,959 filed on November 29, 2007 (entitled "System and Method of Changing Fluidic Circuit Between Hemodialysis Protocol and Hemofiltration Protocol" This application is a continuation-in-part of U.S. Patent Application No. 12 / 324,924, which claims priority to U.S. Patent Application No. 61 / 021,962, filed on even date herewith.

The '490 application is a continuation-in-part of U.S. Provisional Patent Application No. 12 / 249,090, filed on October 11, 2007, which claims priority to US Provisional Patent Application No. 60 / 979,113 entitled "Photo- Acoustic Flow Meter" Application.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 575,449, filed on October 7, 2008, which claims priority to U.S. Patent Application No. 61 / 103,271.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 751,930, filed on March 31, 2009, which claims priority to U.S. Patent Application No. 61 / 165,389.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 705,054, filed on February 12, 2009, which claims priority to U.S. Patent Application No. 61 / 151,912.

The '490 application is a continuation-in-part application of US patent application Ser. No. 12 / 875,888, filed Sep. 28, 2007, which claims the benefit of US patent application Ser. No. 60 / 975,840, .

The '490 application is also a continuation-in-part of U.S. Patent Application No. 12 / 210,080, filed on September 13, 2007, which claims priority to U.S. Patent Application No. 60 / 971,937.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 351,969 filed on January 12, 2009.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 713,447, filed on February 26, 2009, which claims priority to U.S. Patent Application No. 61 / 155,548.

The '490 application is a continuation-in-part of U.S. Patent Application No. 12 / 575,450, filed on October 7, 2008, which claims priority to U.S. Patent Application No. 61 / 103,274.

All of the above listed specifications are incorporated herein by reference in their entirety.

Field of the Invention

The present invention relates to a portable dialysis system having improved structural and functional characteristics. In particular, the dialysis system of the present invention is directed to a portable dialysis system having improved modularity, ease of use and safety features.

BACKGROUND OF THE INVENTION The blood purification system used to perform hemodialysis, hemodiafiltration or hemofiltration involves the extracorporeal circulation of blood through an exchange with a semipermeable membrane. Such a system further comprises a hydraulic system for circulating blood and a hydraulic system for circulating a supplemental fluid or dialysate comprising a specific blood electrolyte at a concentration close to the blood concentration of the healthy subject. However, most commonly available blood purification systems are quite large in size and difficult to operate. Also, the configuration of these systems makes the system difficult to handle and does not help with the use and installation of portable components.

Standard dialysis therapy using a hospital-installed device involves two steps: (a) dialysis where toxic substances and scoriae (usually small molecules) are passed from the blood to the dialysis fluid through the semipermeable membrane, and (b) The pressure difference between the circulation line and the dialysis water circulation path, or more precisely the reduced pressure in the latter circulation path, includes ultrafiltration which reduces the blood content of the water by a predetermined amount.

Dialysis using standard equipment tends to be both expensive and expensive as well as requiring the patient to be tethered to the dialysis center for a long period of time. While portable dialysis systems have been developed, conventional portable dialysis systems have certain disadvantages. First, these are not sufficiently modular, thereby hindering easy setup, movement, delivery, and maintenance of the system. Second, the system is not simple enough for the patient to be reliable and accurate to use. The interface of the system and the manner in which the portable components are used are misused and / or erroneous when used by the patient. In order for the portable dialysis system to be effective, it should be easy and convenient for individuals who are not hygienists to use disposable inputs and data inputs that are sufficiently limited to prevent inaccurate use.

One common configuration of the dialysis system uses a single pass system. In a one-pass system, the dialysate is passed once through the blood in the dialyzer and then discarded. One-pass systems have multiple drawbacks due to the use of large amounts of water. First, estimating the 50% rejection rate by the R.O (reverse osmosis) system requires at least 1000 to 1500 ml / min of water. Second, a water purification system is needed to provide a continuous flow of purified water between 100 and 800 ml / min. Third, at least 15 amps of electrical circuitry is required to pump between 100 and 800 ml of water / min, and fourth, at least 1500 ml / min of spent dialysate and RO rejection water A floor drain or any other reservoir is required.

Conventional systems also require the use of a myriad of tubes, including a fluid circuit of a refinery system, which results in lower reliability due to increased risk of leakage and breakage. In addition to the difficulty of transport due to their large size, conventional dialysis machines also lack flexibility. For example, the adsorbent-based hemodialysis process has a specific set of hardware requirements that are not shared by the blood filtration process. Thus, it would be advantageous to have a common hardware component, such as a pumping system, which can be used so that the dialysis system can be operated not only in hemodialysis mode but also in hemofiltration.

In addition, there is a need for a portable system that can effectively provide the function of a dialysis system in a safe, inexpensive, and reliable manner. In particular, a small dialysis fluid storage system is needed that incorporates a variety of other important functions therein, such as fluid heating, fluid measurement and monitoring, leak detection, and disconnection detection, while meeting the fluid delivery requirements of the dialysis process .

With regard to disconnection detection in particular, it is difficult to effectively detect return line disconnect because most known methods are based on monitoring and detecting pressure changes in the vein catheter tube. Disconnection of the transmission line is usually caused by a situation in which the needle is pulled out. Since the needle generally provides the highest fluid resistance during extracorporeal blood circulation, the pressure change in the transit line due to the needle separation is not critical and may not be readily detectable. In addition, the pressure drop is very low when the catheter separates from the patient ' s body and causes a break in the catheter. Thus, disconnection detection in a transfused venous blood circuit using pressure as an indicator or metric is unreliable and can lead to serious damage. In addition, the method of using the detection of air bubbles as an indication of separation can not be relied on because the separation from the venous catheter is not drawing air into the catheter conduit. As a result, there is a need for an improved apparatus and method for detecting separation in a venous catheter. There is also a need for an apparatus and method that does not require any additional components, such as a moisture pad that must rest on the needle insertion site.

Additionally, there is no satisfactory mechanism in the prior art to maintain volumetric accuracy during the dialysis process, which can be easily carried out at a reasonable cost. Most prior art methods for maintaining the capacity accuracy of the makeup fluid and the discharge fluid are not suitable for use as a disposable device. One prior art approach to maintaining capacity accuracy involves weighing both the makeup fluid and the discharge fluid. However, these measures are difficult to implement in practice. Another conventional method involves using a capacity balance chamber for a dialysis system. However, such chambers are complex to build, costly, and also not suitable for disposable devices. While capacity flow measurement is another known method, the accuracy of this method has not been proven. Furthermore, this method is very difficult to perform in a disposable form for the dialysis system. Another prior art approach involves the use of two piston pumps to achieve capacity accuracy. However, this approach is extremely difficult to implement at a reasonable cost in the disposable form, and it is not economical to operate with the required pumping capacity of about 200 ml / min. Therefore, what is needed is a method and system that can be used to accurately maintain the volume of fluid injected into or removed from a patient.

Furthermore, there is a need for a multi-pass sorbent-based dialysis system that reduces overall water requirements compared to conventional systems. In addition, a one-pass adsorbent-based dialysis system, which provides a lightweight structure with blood and dialysate channels configured to avoid piping of complex mesh of piping, as well as a manifold that can be used in the multi- need.

It would also be desirable to have a portable dialysis system that allows for easy setup, movement, transportation, and maintenance of the system by having a structural configuration configured to optimize the modularity of the system. In addition, it is desirable to have a system interface that allows the patient to enter data or place disposable components that are configured to prevent errors in use and that are sufficiently limited to prevent inaccurate use.

summary

In one embodiment, the present disclosure relates to a dialysis apparatus comprising a controller unit, a housing having a panel, a manifold receiver fixedly attached to the panel, and a base unit, the controller unit comprising a door having an interior surface Wherein the housing and the panel define a recessed area configured to receive the interior surface of the door, the base unit having a planar surface for receiving the fluid container, a scale integrated with the planar surface, A dialysis device comprising a heater in communication relation and a sodium sensor in electromagnetic communication with said planar surface.

Optionally, the manifold receiver includes at least one of a contoured guide, a pin, or a latch. The panel is configured to provide access to a plurality of pumps. The panels are configured to provide access to four peristaltic pumps in a substantially parallel arrangement. The inner surface includes four pump shoe. When the door is received in the recessed area, each of the four pump shoe is aligned to one of the four peristaltic pumps. At least one of the pump shoe is movably attached to the door by a member and a spring. The member is a bolt.

Optionally, the controller unit further comprises a sensor for measuring movement of the member. The controller unit further includes a controller for receiving a measurement of the movement of the member from the sensor and for measuring the fluid pressure based on the measurement.

Optionally, the apparatus is configured to perform dialysis therapy using approximately 6 liters of water, wherein the water is obtained from a non-sterile source. The manifold receiver is configured to receive a molded plastic substrate forming a first flow path that is fluidly separated from the second flow path. Each of said first and second flow paths has a hydraulic diameter ranging from 1.5 mm to 7.22 mm. The molded plastic substrate is coupled to a plurality of pipes, and the plurality of pipes are coupled to the dialyzer. The controller unit further comprises a member connected to the exterior of the housing, the member being configured to physically accommodate the dialyzer.

Optionally, the base unit further comprises a member connected to the exterior of the base unit, wherein the member is configured to physically accommodate the dialyzer. The plurality of piping is configured to be detachably attached to the adsorbent cartridge. The base unit further includes a member connected to an outer surface of the base unit, the member being configured to physically receive the adsorbent cartridge. The controller unit includes a bottom surface, wherein the bottom surface includes a first physical interface and a first data interface.

Optionally, the base unit has a top surface, the top surface comprising a second physical interface configured to complement the first physical interface and a second data interface capable of interfacing with the first data interface . The scale includes a plurality of flexures and hall sensors, each of the bends being in physical communication with the plane surface, and each of the hall sensors being configured to sense a physical displacement. The sodium sensor includes a conductivity sensor.

Optionally, the conductivity sensor includes a coil having a plurality of turns, a capacitor in electrical communication with the coil, the coil and the capacitor forming a circuit, and an energy source in electrical communication with the circulation path do. The conductivity sensor outputs a value indicative of the sodium concentration in the fluid based on the amount of energy input required from the energy source to maintain a constant voltage across the capacitor.

Optionally, the base unit comprises at least one moisture sensor. The base unit includes a door that may be in an open or closed state such that the door is not physically open when the interior surface of the door is received within the recessed area. The base unit includes a door that may be in an open or closed state, wherein the door is locked in a physically closed condition when the interior surface of the door is within the recessed area. The controller unit includes a plurality of sensors in communication with the molded plastic substrate when the inner surface of the door is within the recessed area. At least one of the plurality of sensors includes a pressure transducer. The pressure transducer is in pressure communication with the flexible membrane incorporated in the molded plastic substrate.

Optionally, the controller unit comprises at least one valve component in communication with the molded plastic substrate. The controller unit includes instructions according to a plurality of programs configured to activate the valve component, wherein activation of the valve component causes fluid flow to be directed through one of the two separate fluid paths in the molded plastic substrate . Activation of the valve component depends on the mode of operation of the blood purification system.

Optionally, the valve component has an open position and a closed position, the valve component comprising an orifice closure member adjacent the orifice through which the fluid can flow; The first portion having a first portion and a second portion, the first portion having a displacement member adjacent the orifice closure member when the valve component is in the open position; A first magnet and a second magnet sufficiently adjacent to the displacement member to exert a magnetic force on the displacement member; And a driver for moving the displacement member toward the first magnet, causing the first portion to urge against the orifice closure member, and causing the orifice closure member to abut the orifice.

Optionally, the first portion comprises a housing, an elastic material, a rod and a gap between the elastic material and the rod. The optical sensor is positioned to sense whether the gap in the valve component is present or absent. The first portion includes a rod, and the second portion of the displacement member is a metal body having a larger diameter than the rod. The rod is coupled to the cylinder. The first magnet is larger than the second magnet. The orifice closure member includes at least one of a diaphragm, an elastic material, and a compressible material. The orifice closure member is compressed against the valve seat to close the orifice.

Optionally, the valve component comprises an orifice closure member adjacent the orifice through which the fluid may flow; A movable member physically moveable relative to the orifice closure member; A first magnet and a second magnet with a separation portion; And a driver capable of generating an electromagnetic force, the orifice closure member being compressed against the valve seat when the valve is in the closed position, the movable member being movable from a first position, when the valve is in the open position, The movable member is urged against the orifice closure member to cause the orifice closure member to compress against the valve seat, and the first magnet is moved to the second position when the valve is in the closed position, And the second magnet generate a magnetic field in the separator, the magnetic field having a direction, the electromagnetic force reversing the direction of the magnetic field.

Optionally, the dialysis machine includes an optical sensor positioned to sense whether a gap is present or absent. The first magnet and the second magnet provide a bearing surface for moving the movable member. The first magnet having the first pole is larger than the second magnet having the second pole. The first pole and the second pole repel each other, and the first magnet and the second magnet are configured such that the first pole and the second pole face each other.

Optionally, the controller unit further comprises a valve having a first stable state and a second stable state, the valve comprising a magnet, the energy input to the valve generating a magnetic force, And the displacing member causes a change between the first state and the second state and does not require an energy input to maintain the first or second state.

Optionally, the molded plastic substrate has an orifice that is closed against fluid flow when the valve is in a first steady state and open to fluid flow when the orifice is in a second steady state. The orifice is closed against fluid flow when the displacement member compresses the material into the orifice. At least one of the plurality of sensors is a flow meter.

Optionally, the flow meter includes at least two probes, each probe having a contact surface and a body located on the molded plastic substrate, wherein a first of the at least two probes is responsive to the first thermal signal To generate thermal waves in the fluid flowing through the molded plastic substrate, and a second one of the at least two probes senses the thermal wave in the fluid. The flow meter further includes a reference signal generator, wherein the reference signal generator outputs a reference signal. Wherein the flow meter further comprises a heat source, the heat source being adapted to receive the reference signal from the reference signal generator and to be thermally coupled to a first one of the at least two probes, The second thermal signal having the first thermal signal. The flow meter further includes a temperature sensor, which is configured to thermally couple with the second probe and generates a second thermal signal having a phase derived from the thermal wave. The flow meter further includes a multiplier for receiving an input signal from the reference signal generator, receiving the second thermal signal, and outputting a third signal. The flow meter further includes a low-pass filter for receiving a signal derived from the third signal and for receiving a reference signal from the reference signal generator, the low-pass filter having a cutoff frequency .

Optionally, the second probe is separated from the first probe by a distance of less than two inches. The dialysis device further comprises an amplifier for amplifying the third signal and for generating a signal derived from the third signal. The body of each of the at least two probes has a diameter ranging from 0.03 inches to 0.15 inches. The contact surface of each of said at least two probes has a diameter in the range of 0.025 inch to 0.2 inch. The second probe includes a thermistor. A low pass filter generates a filtered signal, and a reference signal generator generates the reference signal based at least in part on the filtered signal. The flow meter dynamically adjusts the reference signal to maintain a constant frequency. The flow meter dynamically adjusts the reference signal to maintain a constant phase.

Optionally, the flow meter projects the optical beam onto the fluid in the molded plastic substrate; Detecting an acoustic signal formed at a first point upstream of the fluid and at a second point downstream; Measuring a phase difference between the acoustic signal detected at the upstream of the fluid and the acoustic signal detected at the downstream; And to calculate the flow rate of the fluid from the measured phase difference. The phase difference is measured by subtracting a representative signal of the acoustic signal phase detected in the upstream and downstream.

Optionally, the flow meter includes an optical system for projecting an optical beam onto a fluid flowing through a transparent section of the molded plastic substrate; A first acoustic detector for detecting acoustic signals at a first point upstream from the transparent section; A second acoustic detector for detecting the acoustic signal at a second point downstream from the transparent section; And a processor for detecting a phase difference between the acoustic signal detected in the upstream and the acoustic signal detected in the downstream and calculating a flow rate of the fluid in the molded plastic substrate from the measured phase difference.

The processor for measuring the phase difference includes a subtraction unit. The optical system is a pulsed laser system. The optical beam is projected perpendicular to the flow direction of the fluid. The flow meter has an operating detection range of 20 ml / min to 600 ml / min. The flow meter has an operating detection range of 20 ml / min to 600 ml / min. The controller unit further includes a reader for detecting identification data embedded in a further molded plastic substrate. The controller unit further includes a temperature sensor configured to be in thermal communication with the molded plastic substrate when the door is in the recessed area.

Optionally, the controller unit comprises a single line monitor for measuring whether the blood line connection to the patient has been broken. Wherein the single line monitor includes a pressure transducer in pressure communication with the blood flow path in the manifold, a cardiac reference signal generator, a pressure transducer data receiver, a cardiac reference signal receiver, and a processor, Wherein the heart reference signal generator detects and generates a signal indicative of the pulse of the patient and the pressure transducer data receiver receives the signal indicative of a pulse signal in the blood flow path, The processor receives the signal indicative of a pulse of the patient and the processor compares the signal indicative of the pulse signal in the blood flow path and the signal indicative of the pulse of the patient to produce data indicative of a disconnection of the blood line connection to the patient .

Optionally, the single line monitor further comprises a controller, which causes an alarm based on the data indicative of a disconnection of the blood line connection to the patient. The single-line monitor further includes a controller, wherein the controller stops the dialysis pump based on the data indicative of disconnection of the blood line connection to the patient.

Optionally, the pressure transducer generates a signal indicative of a pulse signal in the blood flow path non-invasively. The processor calculates the sum of the signal indicative of the pulse signal in the blood circulation path within a specific time frame multiplied by the pair of corresponding points of the signal representing the pulse of the patient, Lt; / RTI > to each other.

Optionally, the single line monitor further includes instructions according to a program for directing the cardiac signal reference generator to attach to the patient prior to initiating the dialysis pump. The single line monitor includes instructions according to a program for inducing the system to capture the signal indicative of a pulse signal in the blood flow path prior to initiating the dialysis pump.

Optionally, the controller unit further comprises a display, a scale, a barcode reader, and a memory for storing instructions according to a plurality of programs, the instructions comprising: a) A first graphical user interface for the user; b) a second graphical user interface for presentation on the display; And c) generating a third graphical user interface for presentation on the display, wherein the first graphical user interface displays each additive required for use in dialysis therapy, and the second graphical user interface is a user of the system Encourages a plurality of additives to be scanned using the barcode scanner, and the third graphical user interface encourages a user of the system to process a plurality of additives using the scale.

Optionally, the scale is a digital scale. The barcode scanner visually represents a successful reading. The memory further includes table associating a plurality of additive names with a plurality of bar codes. The memory further comprises associating the plurality of additives in a table with a plurality of weight values. The first graphical user interface displays a visual representation of the additive packaging. The third graphical user interface only encourages the user of the system to process the additive using the scale when the barcode of the additive is not recognized. The third graphical user interface merely facilitates measurement processing of the additive using the scale when the user of the system can not obtain the barcode of the additive.

Optionally, the controller unit further comprises a display, a scale comprising a plurality of magnets, an electronic reader, and a memory for storing instructions according to a plurality of programs, wherein, upon execution, the instructions a) A first graphical user interface; And b) creating a second graphical user interface for presentation on the display; Wherein the first graphical user interface facilitates a user of the system to scan a plurality of additives using the barcode scanner, and wherein the second graphical user interface is configured to allow a user of the system to measure a plurality of additives using the scale .

Optionally, upon execution, the instructions further generate a third graphical user interface for presentation on the display, and the third graphical user interface displays each additive required for use in dialysis therapy. The scale is a digital scale, and the digital scale generates data representing the weight of the object placed on the digital scale. The digital scale further includes at least three flexures. Each flexure includes a magnet and a corresponding Hall sensor.

Optionally, the dialysis system further comprises a molded plastic substrate, said molded plastic substrate comprising a first flow path and a second flow path formed therein, said first flow path and said second flow path being connected to a valve Lt; / RTI > The controller unit further includes a memory for storing instructions according to a plurality of programs, the instructions according to the program being configured to form a first state of the valve and a second state of the valve based on the selected operating mode. The selected operating mode is either the start mode or the treatment mode. A first state of the valve causes the first flow path to be in fluid communication with the second flow path. A second state of the valve causes the first flow path to be in fluid shutoff from the second flow path. The dialysis system further comprises a molded plastic substrate comprising a first fluid circuit for injecting fluid into a patient and a second fluid circuit for removing fluid from the patient.

Optionally, the controller unit further comprises: a first pump configured to alternately operate with respect to the first circulation path and the second circulation path; A second pump configured to alternately operate with respect to the second circulation path and the first circulation path; And a controller that causes the first pump to operate alternately with respect to the first circulation path and the second circulation path and causes the second pump to operate alternately with respect to the first circulation path and the second circulation path, The first pump and the second pump of the first pump operate only one circulation path at a predetermined time.

Optionally, the first pump causes a greater amount of fluid to be pumped than the second pump per unit time. The first pump and the second pump alternately operate with respect to the first and second circulation paths at predetermined time intervals, and the time interval is limited by the amount of fluid pumped per unit time by the first pump and the second pump It comes from possible differences. The first pump and the second pump are peristaltic pumps. The dialysis system further includes a restrictor for equalizing the pressure difference between the first and second circulation paths. The limiter is active and equalizes the pressure difference based on the measured pressure difference derived from the first pressure sensor in the first circulation path and the second pressure sensor in the second circulation path.

Optionally, the panel further comprises a funnel formed by two inclined surfaces which are guided into the channel, said channel comprising at least one moisture sensor. Once the door is received in the recessed area, the funnel is positioned below the manifold and configured to direct fluid leaking from the manifold towards the moisture sensor.

Optionally, the lower surface of the controller unit is configured to releasably attach to the upper surface of the base unit. The controller unit is in electrical communication with the base unit. The controller unit is physically separated from the base unit. The controller unit is in data communication relationship with the base unit. The controller unit is in fluid communication with the base unit.

In another embodiment, the present invention is a dialysis apparatus comprising a first unit and a second unit, the first unit comprising a door having a first side, a housing having a second side attached to the door, At least one manifold receiver fixedly attached to two sides and a display for displaying a graphical user interface, said second unit comprising a planar surface for supporting a fluid container, metering means incorporated in said planar surface, A heater in thermal communication with the planar surface, and a sodium sensor proximate the planar surface.

Optionally, the manifold receiver is configured to receive a molded plastic substrate forming a first flow path that is fluidly separated from the second flow path. The molded plastic substrate comprises a first layer; A second layer; A first flow path formed by the first surface of the first layer and the first surface of the second layer; A second flow path formed by the first surface of the first layer and the first surface of the second layer; And a valve in fluid communication with both the first flow path and the second flow path, wherein the valve has a first state and a second state, and when in the first state, Is in a fluid shutoff state, and in the second state, the first flow path and the second flow path are in fluid communication relationship.

Optionally, the molded plastic substrate comprises a first plurality of ports in an opposing arrangement to a second plurality of ports. At least one of the first plurality of ports and the second plurality of ports includes a member having an outer cylinder housing, the member having an inner space defined by a central axis. The central axis is angled with respect to the plane in which the plastic substrate lies. The angle is in the range of 5 degrees to 15 degrees. At least one of the first plurality of ports is formed by a first diameter and a cross-sectional area having a second diameter perpendicular to the first diameter. Wherein at least one of the first plurality of ports is connected to a port channel formed by a third diameter and a cross-sectional area having a fourth diameter perpendicular to the third diameter, the third diameter being greater than the first diameter, The diameter is smaller than the second diameter. The port channel includes at least one protruding member having a height less than the fourth diameter. The port channel is covered by a flexible membrane. The port channel includes at least one protrusion configured such that the flexible membrane is not collapsed into the port channel to completely block the port channel. Sectional area of the port channel is different from the cross-sectional area of the port, and the cross-sectional area of the port channel is configured to maintain a substantially constant fluid velocity through the port to the port channel.

Optionally, the molded plastic is formed by a first segment, a second segment, and a third segment; The first segment being parallel to the second segment; The third segment being perpendicular to each of the first segment and the second segment and attached to each of the first segment and the second segment; The first, second, and third segments form a first flow path that is fluidly blocked from the second flow path.

Optionally, the first segment has a first plurality of ports, the second segment has a second plurality of ports, and the first and second plurality of ports are straight. Wherein at least one of the first plurality of ports and the second plurality of ports includes a member having an inner space formed by a central axis. The central axis is angled with respect to the plane in which the first and second segments lie. The angle is in the range of 5 degrees to 15 degrees. Wherein at least one of the first plurality of ports is formed by a first diameter parallel to the length of the first segment and a cross-sectional area having a second diameter perpendicular to the first diameter. Wherein at least one of the first plurality of ports is connected to a port channel having a third diameter parallel to the length of the first segment and a fourth diameter perpendicular to the third diameter, And the fourth diameter is smaller than the second diameter. The port channel includes at least one protruding member having a height less than the fourth diameter. The port channel is covered by a flexible membrane. The port channel includes at least one protrusion configured to prevent the flexible membrane from collapsing into the port channel. The cross-sectional area of the port channel is different from the cross-sectional area of the port, and the cross-sectional area of the port channel is configured to maintain a substantially constant fluid Raynold's number through the port to the port channel.

Optionally, the third segment is attached to the center of the first segment and the second segment. The third segment is not attached to the center of the first segment or the second segment. The first segment has at least one port, and the inner portion of the port is formed by a flat base. The first segment and the second segment are in the range of 4 to 7 inches in length and in the range of 0.5 to 1.5 inches in width. The third segment ranges in length from 2.5 to 4.5 inches. The first segment having a first length and a first width, the second segment having a second length and a second width, the third segment having a third length and a third width, the first length and the second width, The second length is greater than the third width, and the first width and the second width are less than the third length. The first segment having a first length and a first width, the second segment having a second length and a second width, the first length being equal to the second length, Width.

Optionally, the manifold receiver is configured to receive a molded plastic substrate, wherein a tubular segment connects the molded plastic substrate to the dialyzer. The dialyzer includes a receiver for detachably attaching the dialyzer to an outer surface of the dialyzer. The tubular segment includes a disposable conductivity probe having an internal volume, wherein the internal volume receives fluid flowing through the tubular segment. A disposable conductivity probe is configured to be releasably connected to a mating probe located on the exterior surface of the dialysis apparatus.

In another embodiment, the present invention provides a dialysis machine comprising a first unit in data communication relationship with a second unit, the first unit comprising a door having a pressure plate located on an inner surface of the door, a housing having a panel, The housing and the panel defining a recessed area configured to receive the interior surface of the door, the alignment mechanism releasably receiving the manifold on the panel The second unit comprising a planar surface for receiving a fluid container, metering means for integrating with the planar surface, and means for positioning the manifold relative to the pressure plate when the door is received in the recessed region, A heater in thermal communication with the surface, and a sodium sensor adjacent the planar surface.

In another embodiment, the invention is directed to a multi-pass sorbent-based hemodialysis filtration system that combines hemodialysis with hemofiltration, advantageously in the form of multiple passes.

In yet another embodiment, the invention relates to a blood purification system, such as, but not limited to, hemodialysis filtration and ultrafiltration manifold supports. In one embodiment, the manifold of the present invention includes a composite plastic manifold into which blood and a dialysis fluid channel are formed. These plastic-based manifolds can be used with the multi-pass sorbent-based hemodialysis filtration system of the present invention.

In another embodiment, blood purification system components, such as sensors, pumps, and disposables, are incorporated into the shaped manifold. Disposable articles such as, but not limited to, a dialyzer and adsorbent cartridge may be releasably loaded or fluid in communication with the manifold. Disposable articles such as, but not limited to, a dialyzer and adsorbent cartridge are firmly attached to the manifold and are fixedly attached to the pipeline in fluid communication with the manifold.

In another embodiment, the ultrafiltration system is integrated into the manifold by molding both the blood and ultrafiltrate channels in the manifold. In one embodiment, the manifold described herein comprises a single composite plastic structure, also referred to as a substrate or housing, that can be made by combining two plastic substrate halves.

In another embodiment, the present invention is directed to a dialysis system that supports an electronic based lockout system. Thus, in one embodiment, a reader is provided on the system housing (s) and / or the manifold (s), such as, but not limited to, hemodialysis filtration and ultrafiltration manifolds, Reads the identification indicia for the disposable article loaded on the table. The reader communicates with the database via a network, e.g., a public network or a private network, to check whether the disposable article is valid, correct, or fully compliant and to be safe and ready to use. This is done by querying the information about the disposable article from the remote database based on the recognition index of the disposable article. If the disposable article is in an "ineffective" or "inappropriately" state (based on information received from the database), the system locks out the use of the loaded disposable article, Do not allow the system to proceed for treatment.

The present invention also relates to a diaphragm integrated in a disposable manifold for use in a dialysis machine and configured to be pressurized by components external to the disposable manifold in the dialyzer, A convex outer surface fixedly attached to the manifold at a first end and a second end, the distance between the first end and the second end defining a length and height of the septum, the first end and the second end Wherein the diaphragm at the first end has a height equal to that of the manifold and the height of the convex outer surface increases from the first end to a first height for the manifold, To a diaphragm containing a convex outer surface that decreases to a certain degree.

In one embodiment, the first height of the diaphragm is 0.03 to 0.04 inches with respect to the manifold.

In one embodiment, the diaphragm has a thickness along the length from the first end to the second end, wherein the thickness is substantially constant along the length. In one embodiment, the thickness of the diaphragm is 0.03 to 0.04 inches.

In one embodiment, the total length of the diaphragm is 0.625 to 0.675 inches.

The present invention also relates to a manifold comprising at least one of the diaphragms having the convex outer surface described immediately above.

The present invention is also a diaphragm incorporated into a disposable manifold for use in a dialysis machine and configured to be pressurized by components external to the disposable manifold in the dialyzer, A first substantially planar surface having a bend, wherein a distance between the first end and the first bend defines a length and height of the first planar surface, and wherein the first end is fixed to the manifold Further comprising: a first substantially planar surface, the height of the first planar surface substantially equal to the height of the manifold; A convex outer surface extending from said first curve portion of said first plane surface and projecting outwardly therefrom, said convex outer surface extending from said first curve portion to said second curve portion, and wherein a distance between said first curve portion and said second curve portion is Wherein the convex surface of the first curve and the second curve has the same height as the first plane surface and the height of the convex outer surface is greater than the height of the convex surface of the first curve, 2 < / RTI > height, the height of the convex outer surface decreasing from the second height to the second curvature; And a second substantially planar surface extending from the second curve to the second end, the distance between the second curve and the second end defining a length and height of the second planar surface, Wherein the height of the second planar surface is substantially equal to the height of the first planar surface, and wherein the length of the second planar surface is greater than the length of the first planar surface Wherein the second substantially planar surface is substantially the same as the first substantially planar surface.

In one embodiment, the second height of the convex outer surface is between 0.03 and 0.04 inches with respect to the first substantially planar surface.

In one embodiment, the diaphragm has a thickness along the length from the first end to the second end, the thickness being substantially constant along the length. In one embodiment, the thickness of the diaphragm is 0.03 to 0.04 inches.

In one embodiment, the total length of the diaphragm from the first end of the first planar surface to the second end of the second planar surface is 0.625 to 0.675 inches. In one embodiment, the length of the convex outer surface is 0.125 to 0.15 inches, and the length of the first planar surface and the length of the second planar surface is 0.25 to 0.2625 inches.

The present invention also relates to a manifold comprising at least one of the diaphragms having a first planar surface and a second planar surface and a convex outer surface as just described.

The present invention is a diaphragm incorporated into a disposable manifold for use in a dialysis machine and configured to be pressurized by components external to the disposable manifold in the dialyzer, the diaphragm having a first end and a first bend, Wherein a distance between the first end and the first curve defines a length of the first tapered surface and wherein the first end is fixedly attached to the manifold, 1 sloped surface has a first height at the first end and a second height at the first curve, the second height of the first sloped surface is greater than the second height of the first sloped surface A first tapered surface greater than the first height and wherein the first height of the first tapered surface is substantially equal to the height of the manifold; A convex outer surface extending from said first curve portion of said first inclined surface and projecting outwardly therefrom, said convex outer surface extending from said first curve portion to said second curve portion, and a distance between said first curve portion and said second curve portion Defines a length and a height of the convex surface and the height of the convex surface at the first curve and the second curve is equal to the second height of the first tilted surface and the height of the convex outer surface is greater than the height of the first curve Wherein the height of the convex outer surface is reduced from the second height of the convex surface to the second convex surface, wherein the convex outer surface increases in height from the second height of the convex surface to the second height of the convex surface, ; And a second tapered surface extending from the second curve to the second end such that a distance between the second curve and the second end defines a length of the second tapered surface, And wherein the second inclined surface has a first height at the second curve and a second height at the second end, and wherein the first height of the second sloping surface is greater than the second height at the second manifold, Wherein said second height of said second beveled surface is substantially equal to said first height of said first beveled surface and said second height of said second beveled surface is substantially equal to said second height of said second beveled surface, Wherein the first height of the sloped surface is substantially equal to the second height of the first sloped surface and wherein the length of the second sloped surface is substantially equal to the length of the first sloped surface The present invention relates to a diaphragm including a second inclined surface.

In one embodiment, the second height of the convex outer surface is between 0.01 and 0.02 inches relative to the second height of the first tilted surface and the first height of the second tilted surface, And the first height of the second beveled surface is about 0.02 inches with respect to the manifold.

In one embodiment, the diaphragm has a thickness along the length from the first end to the second end, the thickness being substantially constant along the length. In one embodiment, the thickness of the diaphragm is 0.03 to 0.04 inches.

In one embodiment, the total length of the diaphragm from the first end of the first inclined surface to the second end of the second inclined surface is 0.625 to 0.675 inches. In one embodiment, the length of the convex outer surface is 0.125 to 0.15 inches, and the length of the first sloped surface and the length of the second sloped surface is 0.25 to 0.2625 inches.

The present invention also relates to a manifold comprising at least one of the first inclined surface and the second inclined surface described above, and diaphragms having a convex outer surface.

These and other embodiments are described in the detailed description which should be read in light of the drawings.

These and other features of the present invention will be appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings.
1 is a front view of one embodiment of the dialysis system of the present invention.
2 is a diagram of one embodiment of a dialysis system showing the modularity of the system.
3 is a front view of one embodiment of a dialysis system with the door open;
4 is a plan view of one embodiment of a portable dialysis system showing exemplary dimensions.
5 is a top view of one embodiment of a portable dialysis system showing exemplary dimensions.
6 is a front view of another embodiment of a dialysis system.
7 is a diagram of another embodiment of a dialysis system showing the modularity of the system.
8 is a front view of another embodiment of the dialysis system.
9 is a plan view of one embodiment of a storage unit of the dialysis system.
10 is a schematic view of an exemplary component disposed on a top surface of a storage unit of a dialysis system;
11 is a schematic view of an exemplary attachment part disposed on a top surface of a storage unit of a dialysis system;
12 is a schematic view of an exemplary component disposed on the top surface of a storage unit of a dialysis system.
13 is a schematic diagram of an exemplary component located on the lower surface of the control unit of the dialysis system;
14 is a schematic view of an exemplary interfacing component located on the top surface of the storage unit of the dialysis system;
15 is a schematic diagram of one embodiment of the inner frame of the controller unit of the dialysis system.
16A is a front / side view of one embodiment of the dialysis system of the present invention.
Figure 16b is a front / side view of another embodiment of the dialysis system of the present invention.
16C is a side view of another embodiment of the dialysis system of the present invention.
17A is a schematic view of the internal structure of one embodiment of the storage unit of the dialysis system of the present invention.
17B is a schematic view of the internal structure of one embodiment of the storage unit of the dialysis system of the present invention.
17C is a schematic view of the internal structure of one embodiment of the storage unit of the dialysis system of the present invention.
17D is a circulation diagram of an exemplary conductivity sensor.
17E is a diagram of an exemplary coil used in a conductivity sensor.
18 is a schematic view of a flexure used in one embodiment of the storage unit of the dialysis system of the present invention.
19 is a schematic view of a door locking mechanism embodied in one embodiment of a controller unit of the dialysis system of the present invention.
20 is a schematic view of a door locking mechanism embodied in one embodiment of a controller unit of the dialysis system of the present invention.
21 is a front view of one embodiment of a dialysis system with a door open and a manifold installed;
22 is a schematic diagram of one embodiment of a moisture sensor located on a storage unit of a dialysis system.
23 is a close-up schematic view of one embodiment of a moisture sensor positioned on a storage unit of a dialysis system.
24 is a front view of one embodiment of the storage unit of the dialysis system with the door open;
25 is a schematic diagram of one embodiment of a connector mechanism for attaching an adsorbent cartridge and / or a concentrate complex to a dialysis system.
26 is a first exemplary fluid circuit diagram.
27 is a second exemplary fluid circuit diagram.
28 is a third exemplary fluid circuit diagram.
29 is a fourth exemplary fluid circuit diagram.
30 is a schematic view of one embodiment of an exemplary manifold.
31 is a schematic diagram of another embodiment of an exemplary manifold.
32 is a schematic view of another embodiment of an exemplary manifold having dimensions associated therewith.
33 is a schematic diagram of another embodiment of an exemplary manifold.
34 is a diagram illustrating a first exemplary fluid flow through a port.
35 is a diagram illustrating a second exemplary fluid flow through the port.
36 is a diagram showing one specific example of the angled manifold port structure.
37 is a diagram of one embodiment of a shaped fluid path having a substantially planar base.
38 is a fifth exemplary fluid circuit diagram.
39 is a schematic diagram of another embodiment of an exemplary manifold used in conjunction with another dialysis component.
40 is a schematic diagram of another embodiment of an exemplary manifold.
41 is a front view of an embodiment of a controller unit of a dialysis system with a door open and a manifold installed;
42 is a front view of an embodiment of a controller unit of a dialysis system in which a manifold with a door open is installed using an attachment guide;
Figure 43 is a circulation diagram illustrating an exemplary photo-acoustic flow meter.
44 shows a plurality of propagation signals generated by an exemplary photo-acoustic flow meter.
45 is a circulation diagram illustrating an exemplary thermal flowmeter.
46 shows a plurality of propagation signals generated by an exemplary thermal flowmeter.
Figure 47 shows a plurality of variables that define the operation of an exemplary thermal flow meter.
Figure 48 shows a plurality of propagation signals generated by an exemplary thermal flow meter.
Figure 49 shows a plurality of variables that define the operation of an exemplary thermal flow meter.
50A shows a plurality of propagation signals generated by an exemplary thermal flow meter.
50B shows a plurality of propagation signals generated by an exemplary thermal flowmeter.
Figure 51 illustrates a plurality of variables that define the operation of an exemplary thermal flow meter.
Figure 52 shows a plurality of variables that define the operation of an exemplary thermal flow meter.
Figure 53 is a schematic diagram illustrating an exemplary thermal flowmeter.
54 is a schematic diagram illustrating an exemplary thermal flow meter.
Figure 55 shows a plurality of propagation signals generated by an exemplary thermal flow meter.
56 is a front view of an embodiment of a controller unit of a dialysis system with a door open and a manifold installed;
57 is a diagram of an exemplary temperature probe.
58 is a diagram of an exemplary separation monitoring system.
59 is a diagram of an exemplary separation monitor.
FIG. 60 is a flowchart that specifies an exemplary single line detection process.
Figure 61 is a diagram illustrating an exemplary deployment of a catheter for measuring CVP.
62 is a diagram illustrating an exemplary dialysis system using CVP measurements.
63 is a diagram illustrating an exemplary deployment of catheters and CVP measurements.
64 is a sixth exemplary fluid circuit diagram.
65 is a seventh exemplary fluid circuit diagram.
66 is an eighth example fluid circuit diagram.
67 is a chart illustrating one embodiment of the use of pump swapping to achieve capacity accuracy;
68 is a ninth exemplary fluid circuit diagram.
FIG. 69A is a tenth exemplary fluid circulation path diagram. FIG.
69B is an eleventh exemplary fluid circuit diagram.
69C is a twelfth exemplary fluid circulation path diagram.
70 is a thirteenth exemplary fluid circuit diagram.
71A is a first schematic view of an exemplary magnetic valve system.
71B is a second schematic view of an exemplary magnetic valve system.
71C is a cross-sectional illustration of one embodiment of a manifold diaphragm having an elevated convex surface.
FIG. 71D is a cross-sectional illustration of one embodiment of a manifold diaphragm having elevated convex protrusions centrally located within a substantially planar periphery.
71E is a cross-sectional illustration of one embodiment of a manifold diaphragm having elevated convex protrusions centrally located within the raised convex periphery.
72 is a schematic view of an exemplary magnetic valve system component.
73 is a schematic diagram of another exemplary magnetic valve system.
74 is a diagram illustrating the operation of an exemplary magnetic valve system.
75 is a chart relating to the diaphragm displacement for force for an exemplary magnetic valve system.
76 is a diagram illustrating the operation of an exemplary magnetic valve system.
77 is a flow chart illustrating the operation of an exemplary magnetic valve system.
78 is a diagram of an exemplary hardware implementation for one embodiment of a dialysis system.
79 is a chart showing one specific example of a plurality of additives for use in a dialysis system.
80 is a flow chart illustrating one embodiment of a process for enabling a user to add additives precisely.
81 is a schematic view showing a packaged disposable kit;
82 is a schematic view showing one embodiment of a disposable kit including a manifold and a dialyzer attached to a plurality of pipes;
83 is a schematic diagram showing one embodiment of an electronic lock-out system integrated into a disposable article.
84 is a fourteenth exemplary fluid circuit diagram.
85 is a fifteenth exemplary fluid circuit diagram illustrating the starting mode of operation.
86 is a schematic diagram of another embodiment of an exemplary manifold.

details

The present invention may be embodied in many different forms to facilitate an understanding of the principles of the invention, but will now be described with reference to specific embodiments shown in the drawings, in which the specific terminology will be used to describe it. Nevertheless, it should be understood that the scope of the invention is not intended to be limited thereby. Any modifications and further variations in the invention and the described embodiments, and any further application of the principles of the invention as described herein, will be apparent to those skilled in the art, Will be taken into account.

"Duration" and its variants represent the time lapse of the prescribed treatment from start to finish as to whether the treatment should be terminated due to the condition being resolved and the treatment being discontinued for any reason. Over the course of treatment, multiple treatment periods may be prescribed, during which one or more prescribed stimulants are administered to the subject.

"Period" refers to the time that stimulation "dose" is administered to a subject as part of a prescribed treatment plan.

The term "and / or" means any or all of the listed elements, or any combination of two or more of the listed elements.

The term " comprises "and variants thereof have no limited meaning where these terms are set forth in the detailed description and claims.

Unless otherwise indicated, the singular and "one or more" and "at least one" are used interchangeably and mean one or more than one.

In any of the methods described herein, including individual steps, the steps may be performed in any executable order. And, suitably, any combination of two or more steps may be performed simultaneously.

Also, citation of the numerical range by endpoints herein includes all numbers contained within such ranges (e.g., 1 to 5 are 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, . Unless otherwise indicated, all numbers expressing quantities of ingredients and molecular weights used in the specification and claims are to be understood as being modified in all instances by the term "about ". Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit equivalence principles to the scope of the claims, each numerical parameter should be understood in light of at least the number of significant digits reported and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. However, all numerical values inherently contain ranges necessarily resulting from standard errors present in each of these test measurements.

Device structure

This specification describes embodiments of a modular and portable dialysis system with improved safety and functionality. 1 and 2, in one embodiment, the dialysis system 100, 200 includes an upper unit 101, 201 detachably attached to a base 102, 202. The bases 102, 202 include reservoirs 122, 222 for fluid storage, measurement and monitoring. The upper units 101 and 201, also referred to as the main unit or the controller unit, include a graphical user interface 114 and 214 as pumping units and a door 110 with power lock and mechanical backup mechanism, , 210).

A clasp 105 is used to releasably attach the dialyzer 103 to the first side of the upper units 101, 201. The adsorbent cartridge locking bases 104,204 are used to detachably attach the adsorbent cartridge 107 to the second opposite side of the upper units 101,201. The adsorbent cartridge locking bases 104 and 318 and adsorbent cartridges 107 and 317 are located on the same side of the upper unit 101 as shown in Figure 3 It should be understood. In other cases, the bottom unit may be configured to support the adsorbent cartridge, to support the infusion solution complex, to form shelves on either side of the upper unit to collect any effluents and / or to direct any leaks to the leak detector So that it has a sufficiently larger area than that of the upper unit.

An anti-coagulant pump in the form of a syringe pump 190 exists between the dialyzer 103 and the door 110. Optionally, the upper unit 101 may include a bottle holder having a spiked base for receiving bottles in a top-down manner within the bottle holder housing. The lead is connected to the inlet of the blood pump, the outlet of the blood pump, and the outlet of the dialyzer (blood side). The lead line can also be " threaded " through the bubble detector to sense when the anticoagulant is empty or blocked.

In one embodiment, with respect to FIG. 4, the upper unit 401, including the user interface and the controller, is the same in depth but different in length and height as the base unit 402 comprising a reservoir with integrated scales. In this exemplary embodiment, both the upper unit 401 and the lower unit 402 have a depth D in the range of 10 to 30 inches, more preferably about 19 inches. 4 and 5 are now concurrently concerned, in this exemplary embodiment, the upper units 401, 501 have a length Lt in the range of 6 to 20 inches, more preferably about 14 inches, and the bottom units 402, 502 has a length Lb in the range of 14 to 40 inches, more preferably 27 inches. In this exemplary embodiment, the upper units 401, 501 have a height Ht in the range of 7 to 21 inches, more preferably about 14.5 inches, and the bottom units 402, 502 in the range of 3 to 11 inches And preferably has a height Hb of 7 inches.

5, the base units 402 and 502 further include two shoulder portions 504 extending outwardly from the side of the further centered upper unit 501 along the length of the base unit 502, respectively ). ≪ / RTI > The upper unit is preferably located in the center of the base unit 502, as measured in length Lb in Fig. Thus, the shoulder 504 can be defined as having a length ranging from 4 inches to 10 inches, more preferably about 7 inches. There is a lip 503 that extends upward from the surface of the base unit 502 where the shoulder portion 504 physically meets the upper unit 501 to form a surface on which the upper unit 501 is aligned and disposed. The rib 503 has the same length and depth as the upper unit 501 with a height formed as a difference between Ht2 and Ht while being adjacent to the base of the upper unit 501. [ In one embodiment, the lip height is in the range of 0.1 to 3.5 inches, more preferably 0.6 inches. The overall height Ht3 of the system is in the range of 10 to 35 inches, more preferably 22 inches.

The outer housing structure forming the upper unit 501 and the base unit 502 may each be characterized as a vertical exemption, straight parallel cuboid or box with four sides, an upper portion and a lower portion. In both the upper unit 501 and the base unit 502, in an exemplary embodiment, two of the four sides, each having an outer surface and an inner surface, have the same height, length, and depth, And the upper and lower structures with the inner surface have the same height, length and depth.

It should be noted that the system configurations shown in Figures 1, 2, 3, 4, and 5 are illustrative and not restrictive. For example, the upper unit 301 shown in Fig. 3 has a base unit 302, which, in contrast to being centered (symmetrical base formation) on the top of the base unit 302 with respect to the entire length of the base unit 302, (Asymmetric base formation). Placing the upper unit 301 on one side of the base unit 302 has the advantage that the system places all of the piping connections and consumables on the same side but the adsorbent cartridge 317 and the cataplasm 313 needlessly float Making it more difficult to use the device.

6, in another embodiment, the upper unit 601, which includes a user interface and a controller, has the same depth and length as the base unit 602 including a reservoir in which the scale 604 is integrated, It is different. In this exemplary embodiment, both the upper unit 601 and the lower unit 602 have a depth in the range of 16.0 to 20.0 inches, more preferably less than 24 inches, and a depth of about 17.0 inches. In this exemplary embodiment, the upper unit 601 and the lower unit 602 have a length (Lt) in the range of 10.0 to 15.0 inches, more preferably less than 18 inches or approximately 13.0 inches. In this exemplary embodiment, the upper unit 601 has a height Ht in the range of 10.0 to 14.0 inches, more preferably less than 17 inches, and approximately 12.0 inches, and the bottom unit 602 has a height in the range of 9.0 to 11.0 inches, More preferably less than 13 inches and a height (Hb) of about 9.5 inches. The combined height of the two units is denoted by Ht3. Thus, the base unit 602 and the upper unit 601 have the same footprint even at different heights. It should be appreciated that the base unit 602 and the upper unit 601 may have the same footprint and also the same height.

Extending from under the base unit 602 is a flat side wing 610 that includes a connector for attaching an adsorber cartridge and an injection liquid container 615. The surface of the side wing 610 may include a membrane that can be angled to electronically sense the presence of moisture and / or to direct any moisture to a strategically placed sensor.

7, in an alternate embodiment, the upper unit 701 may include a docking station 705 and a physical (not shown) physical and electrical interface 715 that interfaces electronically and fluidly with the remote base unit 702 Lt; / RTI > The reservoir located in the base unit 702 is still in fluid communication with the controller 701 but the docking station 705 allows greater flexibility in converting the size of the storage system used, Under a usage scenario or allowing for a wider range of patients, for example, a small patient versus a large patient, one controller design can be implemented.

8, in another embodiment, the portable dialysis system 800 integrates an upper subsystem (pumping and control unit) 801 with a lower assembly 802 as described above. The lower portion 802 of the system 800 includes an independent, hanging dialysis bag 805. That is, the dialysis bag 805 is not included as part of the lower assembly 802 as in the previously described embodiment. Additionally, the lower assembly 802 is designed to include a metering mechanism in which it is integrated into a structure 810 that hangs an independent dialysis bag 805. This arrangement is suitable when the dialysis system is configured to operate in the hemofiltration mode because it does not require the use of various sensors used in the hemofiltration mode in the hemofiltration mode, such as ammonia, pH and sodium sensors , So that the entire reservoir assembly module can be removed and the system 800 can simply be operated using the dialysis bag 805. [ The modular and compact design of the lower subsystem 802 facilitates its separation by removing unnecessary components and simplifies system operation in blood filtration mode. This is another advantage of integrating the main component of the dialysis water circuit used during the hemodialysis mode into the lower base unit 802.

The dialysis system of the present invention achieves functional and operational parameters that represent significant advantages over the prior art. 1 to 6, the upper unit is in the range of approximately 20 to 40 pounds, more particularly 30 pounds, and the bottom unit is in the range of approximately 15 to 30 pounds, more particularly 22 pounds, The weight is small. The upper unit is in a range of approximately 1 to 4 cubic feet, more particularly 2.3 cubic feet, and the bottom unit is in the range of approximately 1 to 4 cubic feet, more particularly 2.8 cubic feet, and thus is smaller in volume than prior art systems.

Furthermore, dialysis systems use less water than conventional systems. Conventional systems use approximately 120 liters per treatment, but in one embodiment, the system uses 3 to 8 liters, more particularly 5 to 6 liters. Further, the system does not require a home drain, a supply connection, or a separate outlet for treating excess water.

In addition, there is no need for a separate fluid bag and integrated pump required for startup or movement, with a simpler system configuration and lower power requirements (300 at peak during operation and 50-100 W only). The device operates using a dialysate flow rate of 50-500 Qd (ml / min) and a blood flow range of 20-600 Qb (ml / min). In addition, the capacity accuracy is accurate to less than +/- 30 ml / hr.

As shown in Figure 2, the dialysis system is modular. In one embodiment, the upper unit 201 may be physically separated from the bottom unit 202. The upper unit 201 contains the main electron portion of the system, including a graphical user interface, controller, and pump, formed integrally into a self-contained housing. The larger, more bulky bottom unit 202 contains a reservoir 222. The separation of the system electronics from the reservoir allows each sub-unit to be easily handled, packaged, and transported while allowing the portable dialysis system to be separated into multiple units for installation, service and movement. The arrangement sizes the components for transport to a door carrier via a UPS or other door. It further provides flexibility in product growth. For example, if an improvement is made to the controller unit, or an improvement is made to the reservoir separately (e.g., fluid capacity reduction, or variation in the capacity rating measurement), then the existing consumer is not both, Only one needs to be improved. Similarly, if only one of the two components is broken (for example, if the pump fails), the consumer needs to send one for repair or purchase only one of the two components.

To enable the modularity described above, embodiments of the present invention include, in a first configuration, rigidly attaching the bottom unit 202 to the upper unit 201 and separating the bottom unit 202 from the upper unit 201 Lt; RTI ID = 0.0 > latching < / RTI > Although both systems can simply be stacked on top of one another without a latch, the presence and use of the latches reduces the chance of accidental disconnection. Furthermore, when latched together, the device is easier to move. The latch mechanism preferably does not use a mechanism and is simply accomplished using a male / female mating connection present on the base of the upper unit and the upper surface of the lower unit. Further preferably, the latch mechanism is designed to ensure a firm alignment between the upper unit and the lower unit, whereby an electronic component (e. G., The bottom of the upper unit and the exposed electron on the top of the bottom unit, Connector), which, when the unit is properly aligned, automatically contacts and completes the power circuit. This allows the use of a single power supply and simple connection / disconnection.

9, the bottom unit 902 includes four sides 905a, 905b, 905c, 905d, a base, a top surface 906, and a reservoir 922 accessible through the first side 905d I have. The bottom unit 902 further includes a plurality of latching engagement structures 920a, 920b on its top surface 906. [ In one embodiment, the present invention includes two latch-mating structures 920a, 920b positioned centrally to ensure a uniform weight distribution over the length of the bottom unit 902. The first latch interlocking structure 920a is preferably located at a distance corresponding to 1/3 of the width of the bottom unit 902, when measured from the side 905d. Second latch interlocking structure 920b is preferably located at a distance corresponding to 1/3 of the width of bottom unit 902 when measured from side 905b.

10, the latching mechanism includes a metal frame 1001 that is securely secured to the upper surface of the bottom unit 1005 using, for example, bolts, screws or other fasteners 1002 do. The frame 1001 is flexibly inserted into the corresponding latches and supports the projections or the rectangular members 1003 which can be separated from the corresponding latches.

To rigidly and detachably attach the bottom unit to the upper unit, the upper unit includes a complementary mechanical sliding latch, which is rigidly attached to the base of the upper unit. In one embodiment, the base of the upper unit is preferably located in the center of the upper unit with respect to the length of the upper unit, and at a distance corresponding to 3/1 of the width of the upper unit as measured from the first side, . The base is also preferably located at the center of the upper unit with respect to the length of the upper unit and at a distance corresponding to 3/1 of the width of the upper unit as measured from the second side facing and parallel to the first side 2 latches.

As shown in FIG. 11, the upper unit includes a latch 1100 having a sliding metal flat base 1120. The rail 1130 is slidably engaged with the lower surface of the upper unit with an engagement member for retaining the rail 1130 in place. The latch 1100 has two latching tabs 1115 configured to slide into and out of the mating structure physically attached to the top surface of the base unit.

The latches 1100 attached to the upper unit engage the latching engagement structures 920a, 920b on the upper surface of the bottom unit 906. In operation, when the sliding latch 1100 is in the first position, the upper unit is effectively positioned on the top of the base unit, since the sliding latch 1100 will not physically engage properly with the latch interlocking structures 920a, 920b. They will not be aligned or aligned with the base unit. To fabricate the upper unit to be firmly disposed on the upper surface of the base unit 906, the sliding latch moves within the member support structure located on the bottom of the upper unit and is disposed in the second position. In the second position, the handle of the latch 1111 protrudes, thereby moving the tab 1115 away from the latch interlocking structures 920a, 920b and causing the upper unit to seat properly on the base unit.

12 and 13, an upper unit 1301 with a sliding latch 1380 fits into four cavities or pockets 1230 located adjacent each corner on the top of the bottom unit 1202, Are aligned with respect to the bottom unit 1202 by four small rubber pits on the bottom of the top unit 1301, or footing pad 1340, which are configured or shaped to fit tightly. The upper unit 1301 includes an alignment pin 1260 on the upper surface of the base unit 1202 that is configured or formed to fit tightly into the corresponding cavity 1390 on the lower end surface of the upper unit 1301. [ Or may be accurately aligned with respect to the bottom unit 1202 using protrusions. Also, the bottom unit has a latching engagement structure 1263 as described above.

Aligning the rubber base 1340 with respect to the cavity 1230 and the pin 1260 with respect to the cavity 1390 ensures that the latch 1380 on the upper unit 1301 does not cause the latch mating structure 1263 to over- Lt; RTI ID = 0.0 > and / or < / RTI > Once aligned, the latch 1380 is engaged with the latch interlocking structure 1263 by sliding the latch 1380 into the latch interlock structure 1263, thereby making a tight fit between the two units. 9 and 11 again, to release the latch, the tab 1115 is released from the base unit slots 920a, 920b by pulling or otherwise manipulating the latch handle 1111 so that the upper, So that it is lifted from the bottom unit.

Furthermore, in order to enable the modularity described above, embodiments of the present invention also provide for a robust achievement of a telecommunication and / or data communication connection between the bottom unit and the top unit in a first configuration, To terminate the telecommunication and / or data communication connection between the upper units.

14, the electrical connection between the upper unit and the lower unit is made when the upper unit is placed on the lower unit. This connection is formed integrally with the plate 1402 and includes a non-contact line communication port 1403 and a push-pin power supply 1405 which are firmly attached to the upper surface of the bottom unit 1405 using fasteners 1401. [ (Push-pin power port) 1404. The push- It should be appreciated that the lower surface of the upper unit thus comprises an electrical contact pad in proper alignment with the push-pin. In addition, it should be appreciated that the position of the push-pin and contact pad can be reversed, thus placing the push-pin on the lower surface of the upper unit and the contact pad on the upper surface of the lower unit do.

In one embodiment, the high current power connection is made by placing six spring loaded pins in an electrical contact with the contact pads integrated into the bottom surface of the upper unit. The three pins are +24 volts DC current, and the three pins are for grounding. In one embodiment, the pins or probes have the following characteristics: a) a minimum center of 0.175 inches, b) a current rating of 15 amps (continuous), c) a range of 6.2 oz to 6.2 oz E) a maximum travel in the range of 0.09 to 0.1 inches; f) a work shift in the range of 0.06 to 0.067 inches; g) a nickel / silver and gold H) a stainless steel spring (optionally gold-plated), i) a plunger made of full-hard beryllium copper and gold plating, and j) optionally a stainless steel Stainless steel bias ball. The spring force of the pin assists in preventing breakage by absorbing bending or other distortion. It is to be appreciated that the term electrical pin represents any protrusion capable of transmitting electrical power and that the electrical contact pad represents any surface capable of receiving an electrical pin.

The non-contact infrared communication port 1403 uses two LED transmitters and two LED receivers, which are aligned with and communicate with two LED transmitters and two LED receivers on the bottom surface of the upper unit. The distance between the transmit port and the receive port is less than 0.3 inches. On both the top surface of the bottom unit and the bottom surface of the top unit, the four LED units comprise two pairs, one control pair (including one transmitter and one receiver) and one safety pair And one receiver). These ports are placed in a data communication relationship when the upper and lower units are properly aligned.

In one embodiment, the LED transmitter is a high speed infrared light emitting diode of 870 nm manufactured by GaAlAs double hetero technology. The LED transmitter is a high speed diode with the following characteristics: a) extra high radiant power, b) low forward voltage, c) suitable for high pulse current operation, d) angle of half intensity, e) a peak wavelength of approximately 870 nm, f) a reverse voltage of approximately 5 V, g) a net current of approximately 100 mA, h) a peak net current of approximately 200 mA, i) J) a loss power of approximately 190 mW, k) a junction temperature of approximately 100 ° C, and l) an operating temperature in the range of -40 to 85 ° C. It should be appreciated that the non-contact infrared communication port may be distributed in any functional manner across the top surface of the bottom unit or the bottom surface of the top unit. In addition, it should be appreciated that any other communication port or structure known to those of ordinary skill in the art may be implemented herein.

In one embodiment, the LED receiver is a high speed silicon photodiode with ultra high response time, a radiation sensitive area of approximately 0.25 mm ² , and an angle of half sensitivity of approximately 15 degrees. The receiver has the following characteristics: a) a reverse voltage of approximately 60 V, b) a loss power of approximately 75 mW, c) a junction temperature of approximately 100 캜, d) an operating temperature range of -40 to 85 캜, e) V, f) a minimum breakdown voltage of 60 V, and g) a diode capacitance of about 1.8 pF.

Turning back to Figures 1, 2 and 3, there is a work space in the form of handles 211, 311 and available shelves 112, 212 at the top of the controller unit 201. The handle located on the upper pumping portion of the system is directly connected to the internal structure or frame of the system and is not simply an external plastic molding surrounding the upper units 101,201, an extension of the housing or sheath. The direct connection to the internal frame of such a system is particularly advantageous in that it allows the system to be safely and reliably handled using handles, especially when the device is operating at 6 liters of water (approximately 40 lb addition) .

15, in one embodiment, the upper unit 1501 includes an inner metal casing, frame, or housing 1510, and includes therein and in association with electronics, a controller, and other upper unit components do. The inner casing 1510 includes a horizontal protruding arm 1507 extending to the back surface of the upper unit 1501. The substantially horizontal upper shelf 1505 includes at least one handle 1520, a base bracket 1530 and a vertical arm 1506 integrally formed with the upper shelf structure 1505, To form a single continuous metal or molded plastic piece. The base bracket 1530 is firmly attached to the inner casing 1510 at the front surface of the upper unit 1501 and the vertical arm 1506 is firmly attached to the protruding arm 1507 at the point 1508 using a screw . By rigidly attaching the shelf 1505 and the handle 1520 structure to the inner casing 1510 of the upper unit 1501, Avoiding possible damage or breakage.

A metal door 1562 with a hinge 1565 is also attached to the inner frame or casing 1510 to form the inner frame of the door 110 shown in FIG. The door 1562 is rigidly attached to a plate 1561 that is part of the inner frame 1510. Structures 1563 and 1572 represent inner motor and pulley assemblies and / or protrusions of internal motor and pulley assemblies. A protrusion 1583 extending from the back of the frame 1510 is used to connect various electronic components, including a power supply module and a USB connection 1582. The top of the controller unit, or shelf 1505, is flat and has sidewalls that make it ideal for storage or provisional working surfaces of the feed.

Another structural feature of the controller unit 1601 is shown in Figure 16A. Preferably unit 1601 has a built-in exposed reader, such as a barcode reader or RFID tag reader 1605, which can be used to read codes or tags for disposable components. Operationally, the user will preferably place all codes / tags on the disposable component by the reader. Helping the user can be accomplished through an initial GUI dialysis setup step that directs the user across the reader to each disposable component.

By doing so, the reader obtains identifying information in an internal table stored in a memory for the disposable article, transmits the identifying information to an internal table stored in the memory, compares the recognition information with the content of the internal table, It proves or does not exist that the element (especially the additive used in the dialysis) is present. The contents of the internal table can be created by manually entering identification and amount of the disposable article or by remotely accessing the prescription detailing the identification information and amount of the disposable article. This verification step has at least two advantages. The first is to ensure that the user has all of the necessary components, and the second is to ensure that the correct components are being used (not fake or inadequate disposables). These components can be used to enable a variety of user interfaces, as will be described further below.

In another embodiment, the reader 1605 installed on the side of the upper unit provides the ability to read the bar code in either mode, and in another mode, detects the change in level in the injection liquid container, It is a special multi-function infrared camera. The camera emits an infrared signal that is reflected from the fluid level. The reflected signal is received by the camera's infrared receiver and processed using the processor to determine the meniscus position of the fluid level. In one embodiment, the camera can detect and monitor changes in fluid level at a resolution of 0.02 mm. In one embodiment, the camera is a 1.3 megapixel single-chip camera module with at least one of the following characteristics: a) 1280 W x 1024 H active pixels, b) 3.0 μm pixel size, c) a 1/3 inch optical format, d) an RGB Bayer color filter array, e) an integrated 10-bit ADC, f) defect correction, lens shading correction, image scaling, demosaicing An integrated digital image processing function including sharpening, gamma correction, and color space conversion, g) automatic exposure control, automatic white balance H) programmable frame rate and output derating functions; i) SXGA progressive scan (fps) of 15 fps or less progress i) scan, j) low power 30 fps VGA progressive scan, k) 8-bit parallel video interface, l) 2-wire serial control interface, m) on- o) a separate I / O power supply; p) integrated power management with a power switch; and q) a 24-pin shielded socket option (24). pin shield socket option). In one embodiment, the camera is a 1.3 megapixel camera manufactured by ST Microelectronics of model number VL6624 / VS6624.

The top or bottom unit of the dialysis system also preferably has an electronic interface, e.g., an Ethernet connection or a USB port, to enable direct connection to the network, thereby allowing for remote prescription verification, compliance vigilance, and other remote assistance Thereby facilitating the operation. The USB port allows direct connection to an auxiliary device such as a blood pressure monitor or a hematocrit / saturation monitor. The interface is electronically isolated to ensure patient safety regardless of the quality of the interfacing device.

The front side of the upper unit has a graphical user interface 114 that provides a simple user interface to the system 100. In home settings, it is important that the device is easy to use. The maximum use of color and touch screen is ideally suited for application. The touch screen enables multi-user input configuration, provides multi-lingual capability, and can be easily viewed at night (especially by the brightness control and night-vision color).

The GUI further includes features for automatic opening and closing and locking of the door during operation. In one embodiment, the GUI opens the door to the first latch position, and then the user fully opens the door by pressing the physical door-opening button. In yet another embodiment, the device has a manual overide that allows a user to open the door (e.g., by pressing the door open button twice or by pressing using an additional force) to manually open the door. 16A, there is preferably a visual display adjacent to the GUI 1630 that, when activated, provides a normal function (e.g., a system halt) on the central stop button, regardless of work status, There is a single mechanical button 1610.

To further provide security and safety, the system 1600 may include a door controller 1610, a door controller 1610, a door controller 1620, Lt; RTI ID = 0.0 > 1625 < / RTI > In one embodiment, the reservoir door 1625 is physically attached to, coupled to, or otherwise controlled by the front door 1635 of the upper unit 1601 It is physically blocked not to be opened by the projection 1620. [ A protrusion 1620 that may extend from the optional direction relative to the upper unit 1601 across the reservoir door 1625 serves to provide a physical barrier against opening of the reservoir door 1625. Therefore, in this embodiment, it is not possible to open the reservoir door 1625 without first unlocking and opening the controller door 1635, which is controlled by the user interface.

16B, the dialysis system 1600 includes a single mechanical button 1610 for opening and closing the ammonia sensor 1670, the GUI 1630, and the controller door 1635 And a protrusion 1620 physically attached to or otherwise connected to the front surface door 1635 of the upper unit 1601 and controlled by the front surface door 1635 of the upper unit 1601 And a base unit 1615 with a built-in exposed reader, such as a barcode reader or an RFID tag reader 1605, for example. The controller unit 1601 and the base unit 1615 are located on a single continuous, substantially planar base or divided planar base 1645 with two attachment mechanisms 1675, 1695. A first attachment mechanism 1675 used to hold the adsorbent cartridge 1680 in place is a second attachment mechanism (not shown) that is used to hold the concentrate jar 1695 in place on the same side of the dialysis system 1600 1695). Planar base 1645 preferably includes a drip tray or other moisture catching or sensing surface.

Referring to Figure 16c, the sides of the controller unit 1601 and the base unit 1615 are shown. Adsorbent cartridge 1680 is held in place by attachment mechanism 1675 and concentrate jar 1690 is held in place by attachment mechanism 1695. [ Both sorbent cartridge 1680 and concentrate jar 1690 are disposed on a planar surface, such as the top of drip tray 1668, to allow all moisture to be collected. The scanner 1605 is disposed on the side of the base unit 1615 and in direct optical communication with the concentrate jar 1690. Fluid flows from system 1600, adsorbent cartridge 1680, and concentrate jar 1690 through three tubes or fluid segments 1641, 1642, 1643. The tube segment 1642 places the concentrate jar 1690 in fluid communication with the marketing manifold through the concentrate manifold port. The tube segment 1641 places the adsorbent cartridge 1680 in fluid communication with the manifold through the adsorbent outlet port, thereby delivering the dialysis material required to be regenerated to the adsorbent cartridge 1680. The tube segment 1643 places the sorbent cartridge 1680 in fluid communication with the manifold through the sorbent inlet port, thereby receiving the regenerated dialysate from the sorbent cartridge 1680. The tube segment 1643 can be removed from the side of the controller unit 1601 on the same side as the adsorbent cartridge 1680 by removing the mechanism 1671, e.g., a hook, clip, clamp, or tube segment 1643, The ammonia sensor 1670 is detachably attached adjacent to the ammonia sensor 1670 using other means to be disposed adjacent to and in contact with the ammonia sensor 1670 disposed on the ammonia sensor 1670. [ In one embodiment, the ammonia sensor 1670 includes an optical sensor using the presence of ammonia and a colorimetric measurement approach to determine if the ammonia exceeds a predetermined limit.

1, the storage system 102 may be configured to slide out of the reservoir 122, or otherwise make the reservoir 122 accessible to the user, when not pulled out by any protrusions, Has a door (118) for inserting or changing fluid used for dialysis. The reservoir volume is monitored by a scale system. The scale-based fluid balance 604 shown in FIG. 6, more particularly in FIGS. 17A and 17B, is formed integrally with the reservoir, providing accurate fluid removal data and enabling accurate balance calculations, Prevent outside diseases. By integrating the scales into the reservoir and sealing them completely, a more robust system is provided.

17A, an interior structure 1700 of the storage system is shown. The metallic inner frame 1720 includes two sides 1721, a back side 1722, an open front side 1723, and a base 1724. [ The inner structure or frame is shown without an outer housing as shown as element 102 in FIG. Scale 1718 is incorporated into reservoir interior structure 1700. The lower surface 1715 of the scale 1718 together with the rest of the scale 1718 is supported by four flexures 1705 on a metal surface or fan suspended from an external reservoir housing (shown as 102 in FIG. 1) . Beneath the lower surface 1715 of the scale is a heating pad, such as a square, rectangular, round or other shaped surface, which preferably causes heat to rise and to transfer the increased temperature to the surface 1715 . A conductive coil 1770, which is capable of applying an electric field and is capable of measuring conductivity using changes in such an electric field, is integrated into the base surface 1715. Thus, when a reservoir bag (not shown) is placed on the bottom surface 1715, it can be heated by a heating pad, and since it is in contact with the coil 1770, its conductivity can be monitored have.

The inner surface of side 1721 may include a plurality of rails 1710 that serve to secure, hold, hold or affix a disposable reservoir bag mounting surface 1710, such as a plastic sheet, , A rectangular member, or a protrusion 1719. In particular, the reservoir bag located on the surface 1715 may have an outlet attached to the conduit 1771 that is incorporated in the sheet 1710. Each of the four corners of the scale surface 1718 is provided with a flexor 1705, one of which includes a Hall sensor and a magnet.

Thus, in one embodiment, the components of the reservoir subsystem assembly are a reservoir containing a dialysis reservoir, a dialysis water heater, a dialysis water temperature monitor, a magnetic flexure and a tilt sensor, including a disposable reservoir liner or bag. But are not limited to, a dialysis water ammonia concentration and pH sensor including a metering system, a disposable sensor element and a reuse optical reader, a dialysis water conductivity sensor (non-contact type), and a wetness or leak sensor.

It will be appreciated by those of ordinary skill in the art that, in addition to the sensors listed above, other components in the dialyzer circulation path, such as pumps and sensors, such as pressure transducers, may also be included in the reservoir module. In addition, various sensors, such as ammonia and pH sensors, may be incorporated into the reservoir module as individual sensors or integrated as a single 'sensor sub-module' comprising all of the sensors.

The inclusion of each of these components is designed in such a way as to make the reservoir assembly module particularly suitable for use in operation to recirculate the adsorbent-based dialysis system. In addition, the module is also designed to remove any unnecessary elements of the module that are specific only for adsorbent-based dialysis during other forms of dialysis, such as one-pass hemofiltration.

Figure 17B shows an embodiment of a reservoir assembly module in which the outer skin or cover is transparent so that the internal placement is revealed. An opening 1741 is provided on the front surface of the reservoir subsystem module 1700. The main function of the reservoir subassembly is to contain the dialysate. The opening 1741 allows the insertion of a conventional IV bag-able disposable reservoir bag containing dialysate therein. The reservoir module 1700 is also provided with a fan 1742 inside the front opening for containing the reservoir bag. In one embodiment, both a flat film heater and a temperature sensor are located below the bottom of the reservoir pan 1742 and help maintain the temperature of the dialysis fluid at or near the body temperature. In one embodiment, the temperature of the dialysate fluid can be set by the user.

In one embodiment, the reservoir pan 1742 is suspended in the scale mechanism 1743 as further described below. The scale mechanism 1743 can be used to accurately measure the weight of the dialysate fluid in the reservoir bag prior to the start of dialysis and to maintain a capacity balance of dialysate fluid in the circulation path during dialysis.

On top of the reservoir assembly module 1700, a feature 1744 is provided for attachment to the pumping unit of the dialysis system, as discussed above. These features facilitate easy coupling of the reservoir assembly module and easy separation from the pumping unit, and in one embodiment can be mounted on top of the reservoir assembly. As discussed further below, the top of the reservoir assembly module is also provided with a drain gutter 1745 on one side of the module. Individual wetness sensors (not shown) are provided in each gutter. As is well known in the art, a wetness sensor is an optical device that senses moisture due to increased optical coupling to a fluid, in contrast to air, due to differences in refractive index between air and fluid. The wetness sensor in the drain gutter 1745 keeps track of the moisture and indicates any leakage in the pumping system if it is installed on top of the reservoir assembly. By having a separate wetness sensor on the drain gutter on the other side, the leakage can be localized and specific instructions can be presented to the user for any correction that may be required.

Figure 17c shows another aspect of the reservoir assembly module in which the outer cover of module 1700 has been completely removed and some internal components are transparent. 17C, an internal gutter 1753 is provided in the reservoir pan 1752. The gutter 1753 is further provided with a wetness sensor, which is located directly below the dialyzer fan 1752 and to which a flexure 1755 is attached for sensing the leakage inside the reservoir assembly 1700 .

The reservoir assembly module 1700 further includes a sensor pod 1754 or sub-module that includes a collection of various sensors on the same circulating board. The sensor board particularly includes sensors associated with adsorbent-based dialysis, such as ammonia and pH sensors. In one embodiment, the ammonia sensor comprises a disposable color sensitive strip made of a material that exhibits visual changes in color in response to ammonia levels present in the dialysate. For example, the color of the indicator strip may gradually change from blue to yellow based on the level of ammonia present around the strip. This visual color display makes it easier to keep track of ammonia levels and to identify the occurrence of ammonia breakthroughs. In one embodiment, an optical sensor is used to more accurately evaluate this color change in the ammonia indicator strip. In addition, the optical sensor is located in the sensor module 1754 and can be used to convert general visual color readings to accurate ammonia level indications.

With respect to the sodium concentration of the dialysis water, it should be appreciated that in order to properly perform renal dialysis and induce proper diffusion across the dialyzer, the sodium concentration should be maintained within a certain range. A common way to measure the sodium concentration of a fluid is to measure the electrical conductivity of the fluid and the temperature of the fluid and then calculate the sodium concentration in the approximate. An improved method and system for measuring the sodium concentration in the dialysate in a non-contact manner uses a non-contact conductivity sensor built into the bottom of the reservoir pan 1752.

In one embodiment, the non-contact conductivity sensor is an inductive device using a coil. A change in sodium concentration changes the conductivity of the dialysis solution, which in turn changes the impedance of the coil. By placing a conductivity sensor at the bottom of the reservoir pan 1752, a large surface area is provided to the coil, under the dialysate bag in the reservoir. This ensures high accuracy of the measurement besides not requiring physical contact of the sensor with the dialysate fluid.

17D and 17E, a component of the contactless electrical conductivity sensor including a coil 1788 with an n-number of rotations to cause a magnetic field to be generated when properly activated, and the components of the resistive elements Rs 1786 and Rp 1785 and the inductor element < There is shown a diagram of a resonant LCR tank circulation path 1780, which is produced when a coil formed by the capacitor L 1787 is electrically coupled to the capacitor 1781.

Coil 1788 is a multi-layer circular flat coil that is used as an energy storage device with capacitor 1781. Coil 1788 has a loss element, which is the electrical conductivity of the fluid in the bag, including the electrical resistance (Rs 1786) of the coil wire and the electrical resistance (Rp 1785) of the magnetic-field loss element.

The diameter of the coil 1788 is a function of the magnetic field transmission to the fluid. Another factor for fluid penetration is the operating frequency. The lower operating frequency will penetrate deeper into the fluid, but the loss cost will be lower. Larger coils will have small effects due to dimensional tolerances. A defined equation is presented below:

Where a = the average radius (cm) of the coil, N = the number of revolutions, b = the winding thickness (cm), and h = the winding height (cm). In one embodiment, the radius of the coil is in the range of 2 to 6 inches, more particularly 2, 3, 4, 5, and 6 inches and all increments therebetween.

In relation to the circulation path 1780, the physical coil 1788 is represented by L 1787 and Rs 1786, where L is the inductance of the coil and Rs is the electrical resistance of the coil wire. The energy loss of the magnetic field generated by L (1787) is represented by Rp (1785). The energy loss Rp originates from, and is directly related to, the fluid conductivity close to the coil 1788. Therefore, it is contemplated that the coil 1788 may be disposed within the reservoir pan, or incorporated into the surface of the reservoir pan, or alternatively, the magnetic field generated by the coil 1788 may be provided by the presence of dialysate, or more specifically, When placed at a distance that allows it to be affected, the change in the sodium concentration of the bag and thus the conductivity can be monitored and tracked by tracking the change corresponding to the magnetic field produced by the coil 1788.

The circulation path 1780 can accurately measure the change in the magnetic field generated by the coil 1788. When the circulation path 1780 is driven at its resonant frequency, the energy is shifted back and forth between the inductive element L 1787 and the capacitor 1781. At resonance, the energy loss is proportional to the I ² R loss of R _S and R _P. C 1781, energy must be supplied to the circulation path 1780, and the supplied energy must be equal to the energy loss of R _P (1785) and R _S (1786). When the L 1787 and C 1781 elements are placed in a Pierce oscillator with automatic gain control the control voltage will be proportional to the electrical conductivity of the sensed fluid, Is likely to require more energy to oscillate with higher resistive field losses due to changes in the dialysis conductivity resulting from changes in the sodium concentration level.

As previously mentioned in connection with Figure 17b, the reservoir pan is suspended in a scale mechanism for accurately measuring the weight of the dialysate fluid in the circulation path during dialysis and for maintaining the capacity balance. The suspension point 1755 for the scale mechanism is shown in Figure 17c. In one embodiment, there are four suspension points 1755, each comprising a metering mechanism as described above. In addition to the four suspension points 1755, the reservoir assembly subsystem 1700 also includes a water level sensor. The level sensor even allows the reservoir bag to calculate the correct weight even if it is not horizontal. Figure 17c also shows a pin assembly (not shown) on top of the reservoir assembly module 1700, which can be used to provide electrical connection to the control and / or pumping unit, which may be installed on top of the reservoir assembly, 1756).

18, the flexure 1805 includes a plurality of attachment points 1861 to which the flexure is secured to the outer reservoir housing. The flexure further includes a magnetic body 1862, e.g., two magnets, and a Hall sensor 1864. The base 1867 of the flexure 1805 is attached to the top surface 1715 of the scale 1718. When the scale 1718 is moved due to application of the weight rod (e.g., when the reservoir bag is filled with dialysate, the bag presses the surface 1715, thereby pulling the scale 1718 down) The flexure 1805 connected to the scale and connected to the outer housing at the other end will be bent and the magnets 1862 mounted on one end of the flexure 1805 will be deflected to the magnetic field generated by the magnetic body 1862 We will track such changes by changes. Hall sensor 1864 detects a change in magnetic field strength. One of ordinary skill in the art will understand how to change this sensed magnetic field change to a measure of the applied weight load.

The front door is largely open to load the disposable manifold (approximately 100 degrees). Having a wide opening assists with manifold loading and easy cleaning of the sides of the device and the door. Closing the door and covering the moving part of the device makes the device safer and more robust, which is especially important for household use. In addition, the front door house has a display that saves space, and reinforces the important point that the appliance should not be operated if the disposable article is not in position and the door is closed. The door provides the occlusion force required for the manifold and its pump segment. In addition, the door includes a touch screen, an audio alarm, and a manual stop button on the door surface.

In one embodiment, the door is held in a fully closed position by an electric stepper motor. This motor is operated via the user interface and is operated by the user pressing the button, especially when the door is fully closed or is about to open. It is desirable to have an electronic mechanism in which the structure is placed on the manifold with the door and pump shoe to ensure proper pressure, the door is closed, and sufficient door closing force is generated. In one embodiment, a door closing force of 90 to 110 lbs is generated.

19 and 20, one embodiment of the power door closing mechanism 1900 is shown. The stepper motor 1906 mechanically couples to the leadscrew 1916 thereby causing the stepper motor 1906 to rotate the leadscrew 1916 when actuated by the controller such that the rods 1918 and 2018 Let the propulsion force. The hook located below member 2040 acts to latch the U-latch 2030 and causes the U-latch 2030 to be retracted when it is pulled inward, turned, So that the required closing force of the door is applied. The hook is physically engaged with the rods 1918, 2018 and can be manipulated to push tightly against the U-latch 2030 or loosely engage the U-latch 2030. The power shutdown system is mounted and held in proper orientation by mounting the bracket 1905.

21, in operation, the user fully closes the door to engage the hook 2150 inside the internal volume of the controller unit and the U-latch 2110 on the door. Thereafter, the user is presented with a mechanical button or graphical user interface icon which, preferably, depresses the desire to close the door to the portable dialing device, transmits a signal to the controller and then activates the stepper motor. The stepper motor applies a propelling force to the hook 2150, which then pulls the engaged U-latch 2110 tightly closed. In one embodiment, the controller monitors the torque force exerted by the motor and, when it reaches a predetermined limit, deactivates the stepper motor. In another embodiment, the hole device located adjacent to the leadscope senses the extension of the leadstitch and measures the degree of screw movement. When the screw has moved sufficiently in a direction to create a larger door closing force, the hall sensor sends a signal to the controller to deactivate the motor. Alternatively, the sensor transmits a signal indicative of a constant screw extension, which is subsequently captured by the controller to determine whether sufficient thrust has been applied and whether the stepper motor should be deactivated. In either of these embodiments, if the motor is in over torque, a predetermined distance is exceeded, or the door does not reach its fully closed position within a predetermined time, the controller will cause the motor to be stopped , It can be activated to change to a completely open state. In addition, the controller can also cause a visual and / or audible alarm to sound.

If the user wishes to open the door, a mechanical button or graphic user interface icon is activated, sends a signal to the controller, and then activates the stepper motor in reverse. The hook then loosely engages the U-shaped latch. Thereafter, the mechanical release button is depressed and the loosely engaged hook is released from the U-shaped latch.

In addition to providing the required closing force, these power door closing mechanisms have several important characteristics. First, it is designed to prevent obstacles from being caught by the door and to be treated with a strong door closing force. 21, the area recessed by the door 2105 for receiving the manifold 2130 is in the case where an obstacle such as a human finger or an improperly installed disposable article is between the door 2105 and the base play of the upper unit Is surrounded by four side edge guides 2107 that prevent the door latches from engaging the latch receiver on the upper unit. The door 2105 includes an inner surface 2106 to which a metallic casing 2125 is attached. In one embodiment, the upper surface of the inner surface 2106 of the door 2105 is securely attached to the outer surface of the casing 2125. The casing 2125 is substantially rectangular and forms a cavity with a base 2108 and four sides 2107 forming an internal volume. The cavity is open towards the manifold structure 2130 of the dialysis system 2100 and is a plastic shroud 2130 that surrounds the manifold structure 2130 and preferably at its top and sides Including the guard 2140. On the surface of the base 2108, a pump shoe 2115 and at least one U-shaped latch 2110 protruding toward the back plate are attached. By being integrated or extended, the guard becomes a hook 2150 that is configured to firmly engage or disassociate with the U-shaped latch 2110. If the door is properly closed and there is nothing catching between the door and the guard, the U-shaped latch will be mechanically engaged by the power-door lock hook mechanism. If there is an obstruction in the door path, the metal casing 2125 will not extend (and may not include a guard) to the inner volume of the upper unit, so that the U-shaped latch will not engage the hook, Will prevent the mechanical hooking and accidental power shut-off of the door when in the right place.

Second, the mechanical button release is activated only when the power door closing force is extinguished through the reverse motion of the stepper motor, thereby preventing accidental release and rapid opening of the door. 19 and 20, when the door is closed and locked, a collar 2050 on the button shaft 1907, 2007 rotates 90 degrees to move the push pin away from the power-door locking hook. The collar 2050 rotates at a point 2045 and by a rod 1921 that is connected to the collar in mechanical engagement with the lead screw 1916. Collar 2050 is spring loaded and locked by a small pin solenoid. If the user presses the button while the button is locked, the button will move mechanically, but will not release the hook due to displacement due to the rotation of the collar, thereby preventing the door from opening.

If the power is lost or unintentionally terminated, the pin solenoid will be released, the collar will be rotated 90 degrees backwards, and the push-pins will be arranged in an appropriate arrangement. Thereafter, when the user presses the button, the push pin will contact the power-door hook and release the door latch. This mechanism provides the convenience of mechanical door unlocking and stability support without concern that the mechanical door unlocking can be accidentally activated and the door can open the door with great force. It should be appreciated that the term "hook" or "latch" can be broadly defined as any protrusion or member that can be physically or mechanically bonded to another protrusion or member. In addition, it should be appreciated that the term "U-shaped latch" is not limiting, and any latching or hooking mechanism as described above may be used.

As discussed above, the shelf space defined by the bottom unit, which surrounds the upper unit, utilizes drainage ducts with fluid sensors at a plurality of locations inside and outside the appliance, so as to enable compartmentalized leak detection. In particular, in establishing the drainage to the outer body of the instrument together with the optical leak sensor, the system collects the fluid that is likely to leak from the outer component (such as the adsorbent canister) and sends it to the optical leak sensor. For example, in one embodiment, a manifold 2130 is provided, and the surface 2132 of the upper unit, in which the casing 2125 is disposed to define the cavity, And an angled surface 2190 that forms an area around the manifold 2130 and directs moisture through a gravitational force to a centrally located moisture sensor 2180 . Preferably, the angled surface 2190 is sufficiently inclined to move downward toward one or more moisture sensors 2180 positioned to receive moisture on the angled edges so as to land on the edges. In one embodiment, any one moisture sensor 2180 is centered relative to the position of the manifold 2130 and equidistant from the end of each angled surface 2190.

In one embodiment, at least three different optical leak detectors are incorporated into the outer housing of the bottom unit. 22, the top surface of the bottom unit 2202 is slightly angled, and the center portion 2280 is raised with respect to the side surfaces 2281 and 2282. In one embodiment, the surface is tilted from the central region 2280 to the sides 2281 and 2282 by an angle of 1 to 10 degrees, preferably 3 degrees. A channel 2287 surrounds the top surface of the bottom unit, extends around the periphery, extends through the center of the top surface and / or extends through any other portion of the top surface. By the angled top surface of the bottom unit 2202, the channel 2287 also angles from the central portion 2280 to the sides 2281, 2282. In another embodiment, the top surface is also slightly angled down from the back surface 2291 to the front surface 2290. The angled channel 2287 causes fluid to be directed away from the center and / or rear of the system such that the leak detector 2288 is positioned and directed toward the side in fluid communication with the channel 2287.

The first optical leak detector 2288 is located on the front right corner of the top surface of the bottom unit 2202. The second optical leak detector 2288 is located on the front left corner of the top surface of the bottom unit 2202. Each leak detector is located in a well or cavity and includes an optical sensor located on the side of the well. The optical sensor detects the fluid discharged and / or induced into the well and transmits the detected signal to the controller of the upper unit. The detected signal is processed by the processor to determine if a leak has occurred. Thereafter, the detected signal is stored, and if necessary, the processor issues an alarm or beep to display the GUI. The well or cavity preferably includes a round base to allow the user to easily wipe and dry the well. 23 shows the top surface of the bottom unit 2302 with the channel 2387 and the leak detector 2388 located in the well 2397 in greater detail.

24, at least one additional leak detector is disposed within the bottom unit 2402, and more particularly within the reservoir 2403 where the scale 2404 is integrated. The channels 2405 are integrated into a reservoir structure, such as an inner housing or a metal bag holder, and preferably angled from one side to the other, or from either side to the center. In one embodiment, the angle is in the range of 1 to 10 degrees, more particularly 3 degrees. The wells 2410 that accommodate the leak detector are integrated into the reservoir housing and are in fluid communication with the channel 2405 on one or both sides of the reservoir housing. If a leak occurs in the disposable bag, the fluid will be directed through the channel 2405 to the corners of the reservoir housing or metal pan and into at least one well with the leak sensor 2410.

The drainage pathway provides two functions: a) ensuring that no fluid needs to be introduced into the instrument, and b) ensuring that the spillage is quickly contained and guided to the sensor to trigger a beep or alarm. In addition, the device also preferably includes a fluid drain channel leading into the well with the optical sensor inside the device. Thus, for example, if there is a leak in the internal reservoir, the fluid is guided away from the critical component and the optical sensor warns of a leak. Based on the activated sensor, the GUI can provide an alarm to the user and can specifically identify the fluid leakage location. By providing several independent leak detection zones (several fluid sensors and drainage paths), the instrument cluster can guide the user to quickly find the leak. Having multiple channels and sensors allows the system to partially and automatically identify the source of the leak and provide graphical support to the user as a workaround.

Referring now to FIG. 25, once adsorbent cartridge 2580 is filled with waste material, it can expand and spill if not properly secured to the base. In one embodiment, the adsorbent cartridge 2580 is secured to the base 2520 and is temporarily secured to the base 2520 by a plurality of connectors 2540 physically. Base 2520 is a planar structure having a connector 2510 configured to releasably attach to a mating connector for the base of the dialysis system. In one embodiment, the base unit 2520 includes two mating connectors 2510 with complementary mating connectors for the base unit. Connector 2540 includes at least two, preferably three, or, optionally, more than three L-shaped members. In the three connector configuration 2540, the connectors are uniformly distributed about a circumference slightly larger than the periphery of the base of the adsorbent cartridge 2580. Once the sorbent cartridge 2580 is positioned within the connector, it fits into it and is held in place by the weight of the cartridge 2580. The planar surface 2520 further includes a second set of connectors 2550 that include at least two, preferably three, or, optionally, more than three L-shaped members. In the three connector configuration 2550, the connectors are uniformly distributed about a circumference slightly larger than the periphery of the base of the concentrate jug. Once the concentrate jug is disposed within the connector 2550, it fits into it and is held in place by the weight of the jug 2550.

Exemplary blood and dialysate fluid pathways

The described embodiments can be used to provide a dialysis treatment to a patient. Figure 26 is a functional block diagram of one embodiment of a multi-pass sorbent-based dialysis system of the present invention. In one embodiment, the dialysis system 2600 uses a dialyzer cartridge 2602 that includes a high flux membrane for removing toxins by both diffusion and convection from the blood. Removal of the toxin by diffusion is achieved by establishing a concentration gradient across the semipermeable membrane by allowing the dialysate solution to flow in one direction on one side of the membrane while simultaneously allowing the blood to flow in the opposite direction on the other side of the membrane. In order to enhance toxin removal using hemodialysis filtration, a supplemental fluid is added continuously to the blood either before the dialyzer cartridge (before dilution) or after the stagnant cartridge (after dilution). The amount of fluid equal to the amount of supplemental fluid added is ultrafiltered through the dialyzer cartridge membrane, which transports the added solute with it.

26 and 27, in one embodiment, the blood containing the toxin is pumped by the blood pumps 2601, 2701 from the patient's blood vessels and transported through the catheter cartridges 2602, 2702 Flows. Optionally, the inlet and outlet pressure sensors 2603, 2604, 2703, and 2704 in the blood circulation path are configured to allow the blood to flow through the blood inlet tubes 2605 and 2705 into the dialyzer cartridges 2602 and 2702, , 2706, and then measures blood pressure for both of them. Pressure readings from sensors 2603, 2604, 2628, 2703, 2704, 2728 are used as monitoring and control parameters of blood flow. The flow meters 2621 and 2721 are provided in the blood inflow tubes 2605 and 2705 so as to be caught in a part of the blood inflow tubes 2605 and 2705 located directly upstream from the blood pumps 2601 and 2701, Can be in a relationship. Flow meters 2621 and 2721 are located to monitor and maintain the predetermined blood flow rate in the impure blood supply line. The supplemental fluid 2690 can be added continuously to the blood after (before diluter) dialyzer cartridge (after dilution) before dialyzer cartridge.

262 and 272, the dialyzer cartridges 2602 and 2702 are configured to provide a semipermeable membrane that divides the dialyzers 2602 and 2702 into blood chambers 2609 and 2709 and dialysis chambers 2611 and 2711, respectively. And membranes 2608 and 2708. The blood passes through the blood chambers 2609 and 2709 and the urine is filtered through the semipermeable membranes 2608 and 2708 due to the convective force. Additional blood toxins are transported through the semipermeable membranes 2608 and 2708 by diffusion primarily induced by differences in the concentration of fluid flowing through the blood chamber and through the dialysis chambers 2609, 2709 and 2611, 2711, respectively. The dialyzer cartridge used may be of any type suitable for hemodialysis, hemodialysis filtration, hemofiltration, or hemoconcentration as is known in the art. In one embodiment, the dialyzer 2602, 2702 includes a high flux membrane. Examples of suitable dialyzer cartridges include Baxter CT 110, CT 190, Syntra 160, or Minntech (Minneapolis, Minn.) Available from Fresenius® F60, F80, Baxter (Deerfield, Ill.) Available from Fresenius Medical Care But are not limited to, Minntech Hemocor HPH 1000, Primus 1350, 2000,

In one embodiment of the invention, dialysis water pumps 2607 and 2707 draw dialysed water from dialyser cartridges 2602 and 2702 in a multi-pass loop to dialysate recovery system 2610 and 2710, and To the dialyzer cartridges 2602 and 2702 again via 2613 and 2713, thereby creating a "regenerated" or new dialyzer. Optionally, flow meters 2622 and 2722 interfere with the dialysis water supply tubes 2612 and 2712 consumed upstream from the dialysis water pumps 2607 and 2707 to monitor and maintain a predetermined dialysis flow rate. Blood leak sensors 2623 and 2723 are also fitted into the spent dialysate supply tubes 2612 and 2712.

The multi-pass dialysate regeneration system 2610, 2710 of the present invention includes a plurality of cartridges and / or filters containing an adsorbent to regenerate spent dialysate. By regenerating dialysate with adsorbent cartridges, the dialysis systems 2600, 2700 of the present invention require only a small fraction of the dialysate of a conventional one-pass hemodialysis machine.

In one embodiment, each adsorbent cartridge in the dialysate recovery system 2610, 2710 is a miniaturized cartridge containing a separate adsorbent. For example, the dialysate recovery system 2610, 2710 may use five adsorbent cartridges, each cartridge containing separately activated charcoal, urease, zirconium phosphate, hydrous zirconium oxide, and activated carbon. In another embodiment, each cartridge may comprise a plurality of adsorbent layers as described above, and there may be a plurality of such separate layered cartridges connected in series or in parallel with the dialyzer recovery system. Those of ordinary skill in the art will recognize that active charcoal, urease, zirconium phosphate, hydrous zirconium oxide, and activated carbon are not the only chemicals that can be used as adsorbents in the present invention. In fact, any number of additional or alternative adsorbents, including polymer-based adsorbents, can be used without departing from the scope of the present invention.

The sorbent-based multi-pass dialysis system of the present invention provides multiple advantages over conventional one-pass systems. These advantages include:

The system of the present invention does not require a continuous water source, a separate water purifier or a floor drain because it continuously reproduces a given volume of dialysate. This improves portability.

• Because the system of the present invention circulates the same small volume of dialysate throughout the dialysis filtration process, the system requires a low amperage power, for example 15 amps. Therefore, there is no need for additional dialysis water pumps, concentrate pumps, and large heaters to be used in high-volume dialysis of one-pass dialysis systems.

● The system can use tap water of a low capacity in the range of 6 liters, from which dialysate can be manufactured for pre-treatment.

• The adsorbent system uses adsorbent cartridges that serve as both water purification and means for regenerating the used dialysate with fresh dialysate.

Although the present embodiment has separate pumps 2601, 2701, 2607, 2707 for pumping blood and dialysate through the dialyzer, in alternate embodiments, blood and / or blood may be delivered through the hemodialysis filtration system 2600, A single dual channel beating pump may be used to advance both dialysate. In addition, centrifugal, gear, or bladder pumps may be used.

In one embodiment, the excess fluid waste is removed from the spent dialysis effluent in the spent dialysis tubing 2612, 2712 using the capacitive waste micro-pumps 2614, 2714 and is withdrawn periodically through the outlet, And is placed in a waste collection reservoir 2615, 2715 that can be emptied into the waste collection reservoir 2615, 2715. An electronic control unit 2616, including a microprocessor, monitors and controls the functions of all components of the system 2600.

In one embodiment, dialysis filtered blood exiting the dialyzer cartridges 2602 and 2702 is directed from the supplemental fluid containers 2617 and 2717 to the blood outlet tubes 2606 and 2706 via the capacitive micro-pumps 2618 and 2718 Is mixed with a controlled volume of sterilized supplemental fluid to be pumped. The replenishment fluid is typically available as a sterile / non-pyrogenic fluid contained in a flexible bag. In addition, such fluids can be generated on-line by filtration of non-sterile dialysate through suitable filter cartridges which render them sterile and non-heat-resistant.

28 is a functional block diagram illustrating one embodiment of the ultrafiltration treatment system 2800 of the present invention. 28, blood is supplied from the patient to the blood inlet pipe 2801 by a pump 2802 such as an interlocking blood pump that sends blood to the blood filtration cartridge 2804 through the blood inflow port 2803 . The inlet and outlet pressure transducers 2805 and 2806 are connected in-line just before and after the blood pump 2802. The hemofilter 2804 includes a semi-permeable membrane which, by convection, allows the excess fluid to be ultrafiltered from the blood passing therethrough. The ultrafiltered blood is further pumped from the blood filter 2804 to the blood outlet port 2808 through the blood outlet port 2807 and injected into the patient again. Adjusters, such as clamps 2809 and 2810, are used in pipes 2801 and 2808 to regulate fluid flow therethrough.

A pressure transducer 2811 is connected near the blood outlet port 2807 and a bubble detector 2812 is connected downstream of the pressure transducer 2811. An ultrafiltrate pump, for example, a peristaltic pump 2813, draws ultrafiltrate waste from a hemofilter through an ultrafiltrate (UF) discharge port 2814 and discharges it to a UF discharge tube 2815. Pressure transducer 2816 and blood leak detector 2817 are displaced to UF discharge tube 2815. The ultrafiltrate waste is finally pumped into the waste collection reservoir 2818, such as a flask or soft bag, with an exit port that allows it to attach to the legs of the outpatient and allow intermittent bleed. The amount of ultrafiltrate waste produced may be monitored using any measurement technique including meter 2819 or flow meter. Microcontroller 2820 monitors and manages the operation of blood and UF pumps, pressure sensors as well as air and blood leak detectors. Standard luer connection joints, such as luer slips and luer locks, are used to connect the tubing to the pump, blood filter and patient.

Another blood and dialysate circulation path that can be implemented or used in embodiments of the dialysis system is shown in FIG. 29 shows a fluid circulation path for an extracorporeal blood treatment system 2900 used for performing hemodialysis and blood filtration. In one embodiment of the invention, the system 2900 can be implemented as a portable dialysis system that can be used by a patient to perform dialysis in the home. The hemodialysis system includes two circulation-blood circulation passages 2901 and 2902. Blood treatment during dialysis includes extracorporeal circulation through an exchange-hemodialyzer or dialyzer 2903 having a semipermeable membrane. The patient's blood circulates in the blood circulation path 2901 on one side of the membrane (dialyzer) 2903 and the dialysis fluid containing the main electrolyte of the blood at the concentration prescribed by the doctor circulates on the other side in the dialysis water circulation path 2902 Thus, the circulation of the dialysate fluid provides control and regulation of the electrolyte concentration in the blood.

A line 2904 from a patient delivering impure blood to the dialyzer 2903 in the blood circuit 2901 is provided with a blockage detector 2905 that is generally connected to a visual or audible alarm that signals any interference with blood flow. . To prevent coagulation of blood, delivery means 2906, such as a pump, syringe, or any other infusion device, is also provided for injecting an anticoagulant such as heparin into the blood. Peristaltic pump 2907 is also provided to allow blood to flow in the normal (desired) direction.

The pressure sensor 2908 is provided at the entrance where impure blood enters the dialyzer 2903. Other pressure sensors 2909, 2910, 2911 and 2912 are provided at various locations in the hemodialysis system to track the fluid pressure and maintain it at the desired level at a particular point in each circuit.

At the point where the used dialysate fluid from the dialyzer 2903 enters the dialysate circulation channel 2902, a blood leak sensor 2913 is provided to sense and alert any leaks of blood cells into the dialysate circulation path. Under initiation conditions or at other times deemed necessary by the actuator, the dialyzer can be bypassed from the dialysate fluid flow, and to allow the dialyzer fluid flow to still be maintained, i.e., to flush and priming the operation , A pair of bypass valves 2914 are also provided at the start and end points of the dialysis water circulation path. Another valve 2915 is provided just prior to the priming / drain port 2916. Such a port 2916 is first used to fill the circulation path with the dialysate solution and to remove the dialyzer fluid used after dialysis and, in some instances, during dialysis. During dialysis, valve 2915 can be used to replace the portion of the dialyzate used that contains a high concentration of, for example, sodium, with an appropriate concentration of supplemental fluid so that the total component concentration of the dialysate is maintained at the desired level.

Two peristaltic pumps 2917 and 2918 are provided in the dialysis water circulation path. Pump 2917 is used to pump the dialysis fluid into the dialyzer 2903 as well as to pump the dialysate fluid to the drain or waste container. The pump 2918 pumps the used dialysate from the dialyzer 2903 and maintains the fluid pressure through the adsorbent 2919 and pumps the dialysis fluid from the port 2916 to fill the system, It is used to maintain the concentration.

An adsorbent cartridge 2919 is provided in the dialysis water circulation path 2902. [ Adsorbent cartridge 2919 may contain several layers of material each having the role of removing impurities, e.g., urea and creatine. The combination of these layered materials allows water suitable for potable water to be charged into the system for use as a dialysis fluid. This also allows closed circuit dialysis. That is, the adsorbent cartridge 2919 enables the regeneration of fresh dialysate from the spent dialysate from the dialyzer 2903. For fresh dialysis fluid, a suitable volume, for example, 0.5, 1, 5, 8 or 10 liters of lined vessel or reservoir 2920 is provided.

Depending on the needs of the patient and on the basis of the physician's prescription, a desired amount of infusion solution 2921 may be added to the dialysis fluid. Injection solution 2921 is a solution containing glucose that helps replenish minerals such as potassium and calcium in the dialysate fluid at a level after undesired removal by minerals and / or adsorbents. Peristaltic pump 2922 is provided to pump the desired amount of injection solution 2921 into vessel 2920. Alternatively, the infusion solution 2921 may be pumped from the reservoir 2920 to the outflow line. A camera 2923 may optionally be provided to monitor the changing liquid level of the infusion solution as a safety check warning for injection fluid flow breakdown and to serve as a barcode sensor for scanning barcodes associated with additives used in the dialysis process. Immediately, an ammonia sensor 2928 may be provided.

A heater 2924 is provided to maintain the temperature of the dialysate fluid in the vessel 2920 at the desired level. The temperature of the dialysate fluid can be sensed by a temperature sensor 2925 positioned just prior to fluid entry into the dialyzer 2903. The vessel 2920 is also provided with a meter 2926 for continuing the weight tracking of the fluid in the vessel 2920 and for continuing volume tracing accordingly and a conductivity sensor 2927 for measuring and monitoring the conductivity of the dialysate fluid. Conductivity sensor 2927 provides an indication of the sodium level in the dialysis fluid.

A medical port 2929 is provided before the blood from the patient enters the system for dialysis. Another medical port 2930 is provided before the clean blood from the dialyzer 2903 is returned to the patient. Air (or bubble) sensor 2931 and pinch clamp 2932 are used in the circulation loop to detect any air, gas or gas bubbles and prevent them from being returned to the patient.

The priming set (s) 2933 is coupled to the dialysis system 2900, which assists in preparing the system by filling the blood circuit 2901 with aseptic brine before being used for dialysis. The priming set (s) can consist of short segments of a tube having a combination of IV backspike or IV needle or both pre-attached.

Some of the above-mentioned embodiments disclose the incorporation and use of ports that accept an injection or administration of an anticoagulant to create an air-blood interface, but if the device is capable of operating with minimal blood clotting risk at entry and exit ports , It should be appreciated that such ports may be removed. As discussed further below, the manifold design, and in particular the manifold design associated with the internal design of the manifold port, minimizes the risk of blood clotting and provides an option to remove the air-blood interface that accepts injection or administration of the anticoagulant Respectively.

Those skilled in the art will appreciate from the above discussion the complexity of an exemplary fluid circuit for a hemodialysis and / or blood filtration system. When executed in a conventional manner, such a system would appear as a net of tubes and would be too complex for a home dialing user to configure and use. Thus, in order to simplify the system and facilitate ease of use by the patient at home, embodiments of the present invention are implementing a fluid circuit in the form of a compact manifold, and most of the components of such a fluid circuit are made of a single Or integral with the multiple portions of the molded plastic that are configured to form a single working manifold structure.

An exemplary manifold

It should be appreciated that the multi-pass dialysis treatment process indicated by the blood and dialysate circulation pathways described above can be performed in and by a plurality of blood and dialysate circulation conduits molded into disposable manifolds. As shown in FIG. 21, embodiments of the dialysis system described herein provide for multiple blood and dialysis circuit circulations and provide fluid communication with pressure sensors, meters, and pumps in a pressure, thermal, and / or optical communication relationship. Lt; RTI ID = 0.0 > 2130 < / RTI >

In one embodiment, the manifold of the present invention comprises a composite plastic manifold, in which blood and a dialysate flow path are molded. Blood purification system components, such as sensors and pumps, are in pressure, thermal, and / or optical communication with the fluid flow contained within the shaped manifold. And 30 illustrate the structural components of a compact manifold according to one embodiment of the present invention. Disposable manifolds pump and direct fluid flow while measuring pressure in the main area. These fluids include blood, dialysate, infusion fluids and anticoagulants. The manifold also provides the feature of detecting blood leaks from the dialyzer, detecting occlusion in the arterial line, and detecting air in the venous line.

Referring to Figure 30, in one embodiment, the compact manifold 3000 includes a plurality of plastic layers having components fixedly attached therein. More particularly, manifold 3000 includes the following components:

The rear cover 3001,

Pressure Transducer Membrane (3002)

Valve membrane 3003

Intermediate body 3004

· Front cover (3005)

Pump tube segment (not shown in FIG. 30).

The middle-body layer 3004 contains a channel that is embossed on one side. These channels are completed by a front cover layer that is fixedly attached to the mid-body by any number of methods including ultrasonic welding. This combined front cover-mid-body structure forms a major part of the fluid path in the manifold. On the opposite side of the mid-body 3004 there is a feature that forms a surface for valve actuation and pressure sensing in communication with the fluid path on the manifold's front cover side. The manifold includes valve actuation and pressure sensing resilient parts. These elastic parts are secured between the back cover layer and the mid-body layer through the use of ultrasonic welding, completing the fluid path across the manifold.

Referring to FIG. 30, in one embodiment, the manifold 3000 includes five pressure transducer membranes 3002 and three to four membranes 3003 for a two-way valve. In one embodiment, the two covers 3001 and 3005, the manifold 3000 and the intermediate body 3004 are molded of a polycarbonate material or ABS (acrylonitrile butadiene styrene). The pressure transducer membrane 3002 and the valve membrane 3003 are molded with conventional materials such as Santoprene and more preferably Sarlink, a medical grade elastomeric polymer. In one embodiment, the front and back covers 3005 and 3001 can be formed of an optically transparent material, at least transparent to the wavelength of the particular preselected light, to enable microscopic analysis of the fluid (s) contained therein .

Additionally, the manifold preferably includes four pumping parts. These pumping components are segments of formulated and dimensioned extruded PVC tubing that have properties optimized for pump use, especially roller pump use. This tube is coupled to a barbed fitting that is integrally molded into the manifold mid-body. One of the four pumping components is to draw blood from the patient's artery and pump it back into the patient's vein through the dialyzer. The two pumping components are for dialysis fluid flow and one for infusion fluid delivery to the dialysate fluid circuit. A separate syringe pump can be used to pump the anticoagulant into the arterial route before the dialyzer.

In one embodiment, the manifold is configured to provide a flow of fluid to the other side of a disposable set, including a dialyzer, adsorbent cartridge, bag reservoir, infusion fluid container, patient blood line, anticoagulant, sensor, priming line, and drain, In order to connect all the fluid paths in the manifold to the part, a tube port, preferably a range of 10 to 14 ports, more preferably 12 ports is additionally included.

In one embodiment, the manifold comprises a first segment and a second segment parallel to each other, and a) perpendicular to the first segment and the second segment, and b) having a connecting segment having a role of connecting the first segment and the second segment It looks like the letter "I". In one embodiment, the connecting segment connects the middle of the first segment to the middle of the second segment such that the distance between the connecting segment and each end of the first and second segments is the same distance. It should be appreciated that the connecting segment may be located at the ends of the first segment and the second segment and may be a letter "C" or a "C" The manifold also need not be oriented in the letter "I" shape if it can be rotated relative to the dialysis system. For example, the manifold can be positioned on the side of the dialyzer or at an angle. 32, manifold 3200 has the following dimensions: L1 and L2 are in the range of 4 to 7 inches, preferably 5.7 inches, L3 and L4 are in the range of 0.5 to < RTI ID = 0.0 > 1.5 inches, preferably about 1 inch, and L5 is in the range of 2.5 to 4.5 inches, preferably about 3.5 inches, and L6 is in the range of 1 to 3 inches, preferably about 1.8 inches. While dimensions are provided, it should be appreciated that the invention disclosed herein is not limited to any particular dimension, or set of dimensions.

In one embodiment, the process of assembling the manifold 3000 includes physically attaching or contacting the first side of the membrane to the mid-body and placing the second side of the membrane in a hole, space, or cavity in the back cover 3001 Includes coupling the back cover 3001 to the mid-body 3004 while passing through the cavity 3011 to secure the membranes 3002 and 3003 in place. The cover portion 3001 can be divided into two portions, an upper portion and a lower portion, the upper portion including a central vertical portion 3082 and an upper portion of the upper horizontal section 3080, And a lower portion of the lower horizontal section 3085. In this embodiment, the upper and lower portions of the cover 3001 may be separately joined to the mid-body 3004 and include a material in the middle partial region 3083 of the central vertical portion in relation to the continuous cover 3001 The material cost can be reduced. Preferably, the second side of the membrane has a layered structure in which the first layer passes through the void 3011 and the second layer is held between the rear cover 3001 and the mid-body 3004. This structure attaches the membranes 3002 and 3003 into the back cover 3001. [ In addition, it is desirable for the mid-body 3004 to include a recess into which a first side of the membranes 3002, 3003 may enter and attach such membranes to the mid-body 3004 . In an alternative configuration, the membranes 3002 and 3003 may be co-molded into the back cover 3001 in a multi-shot molding process.

Those skilled in the art will recognize that the various components of the manifold may be combined or attached by any suitable means. In one embodiment, the sealing between the mid-body and the back cover is accomplished through ultrasonic welding or adhesives. Alternatively, laser welding may be used. The front cover is coupled to the other side of the intermediate body in a similar manner. The pump tube segment may be solvent bonded to the seat, in one embodiment, or alternatively, such segment may be laser welded by using a laser absorbing additive in the plastic.

In one embodiment, the front cover is molded of BASF Terlux 2802HD, ABS, which is transparent and provides visibility to the fluid path. The transparency of the ABS will also provide a means for inspecting the integrity of the ultrasonic welded surface. ABS is preferred for its biocompatibility as well as for compatibility with ultrasonic welding. Additionally, the front cover may include a molded in textured surface to help facilitate better bonding between the front cover and the mid-body. Such a textured surface is a chemical etching process known to those skilled in the art. One preferred texture depth is 0.0045. "Other suitable textures can also be laser etched. The surface welded on the front cover is designed with a 0.003" recess, which is reflected by the 0.003 "raised surface on the mold This provides an accurate surface to accommodate texturing. When texturing is performed on the mold, the height of such 0.003 "surface is lowered. 0.0045 "Due to the peak and valley of the texture depth, the average is estimated to be half of that amount or 0.00225". The result will form the mold with a steel plate safety condition of 0.00075 ". The cover 3005 may also be in the form of a central vertical portion 3090 and may not include upper and lower horizontal portions 3091 and 3092 The central vertical portion 3090 is located in a recessed region defined by the raised edge on the surface of the mid-body 3004 opposite the surfacing facing cover 3001, And can be coupled to the mid-body 3004 by coupling its central vertical portion 3090 within the recessed region.

In one embodiment, the front cover provides a blood flow director in both the arterial and venous pathways. These features are designed to minimize hemolysis. The blood flow indicator is provided for a consistent cross-sectional area throughout the path and minimizes sharp edges where blood will be in contact if they are not present. The walls on the opposite side of the blood flow indicator are removed to provide a more consistent wall thickness of the molded plastic part. This will prevent sinks in these areas that can affect the enclosed welded surface. In one embodiment, the front cover wall thickness is 0.075 ".

Optionally, the front cover is provided for assembly purposes and has an alignment hole that allows the front cover and the mid-body to be precisely aligned during the ultrasonic welding process. The raised protrusions around the alignment holes help maximize the contact of the welding fixture with the alignment pins, so that the plastic is not easily melted due to friction. These protrusions do not contact the mid-body and are not welded to it, thus making the hole clear.

Figure 31 provides a perspective view of a mid-body part of a compact manifold of the present invention. 31, a complete blood and dialysate channel 3101 of a hemodialysis / hemofiltration system is formed into a mid-body. Various functional elements of the blood purification system, such as the receiving means of pumps, valves and sensors, are also integrated into the mid-body part of the compact manifold.

The mid-body can be molded with BASF Terlux 2802HD, ABS. Another alternative ABS is Lustran 348, White. ABS is chosen for its biocompatibility as well as its compatibility with ultrasonic welding. The mid-body with the front cover provides a fluid path channel for the manifold. The mid-body contains an energy indicator for butt joint style ultrasonic welding. In one embodiment, the dimensions of the energy indicator are 0.019 "high and 0.024" wide in base. This results in a cross-sectional area of 0.00023 square inches. The width of the weld surface is 0.075 "to create a weld volume of about 0.003" x 0.075 ". Due to its simplicity and ability to control the geometry of the shaped portion, It is preferred over other styles, such as tongue and groove, step joints, etc. Vents are provided in the weld geometry to prevent entrapped gas from being contained through the welds and creating a poor weld that may leak.

The mid-body back cover side preferably provides a molded textured surface to help facilitate better bonding between the back cover and the mid-body. Such a textured surface is a chemical etching process known to those skilled in the art. The desired texture depth is 0.0045 ". Other suitable textures can also be laser etched. The surface welded on the mid-body is designed with a 0.003 "recess, which is reflected in the 0.003" raised surface on the mold . When texturing is performed on the mold, the height of such 0.003 "surface is lowered. 0.0045 "Due to the peak and valley of the texture depth, the average is estimated to be half of that amount or 0.00225". The result will form the mold with a steel plate safety condition of 0.00075 ".

The size of the part to be welded can have a major impact on the success of the ultrasonic welding process. The larger the surface area, the more difficult the welding process becomes. It is important that the weld surface is precisely controlled. The consistent thickness of the front and back covers is more important than the flatness, since the slightly off-flatness of the flatness will be flattened during the welding process. The mid-body flatness is important due to the structural design which will prevent the intermediate-body from being flattened during the welding process. Due to this problem, it is very important that the parts are designed correctly and that malformations such as torsion, sinks, dimensional deformations and the like are not easy. It is also necessary that the mold construction and quality match the high levels at which the parts need to be matched. This will lead to the conclusion that molding process control will also require the highest standards.

The back cover can be molded from BASF Terlux 2802HD, ABS. The back cover contains an energy indicator for ultrasonic welding in a counter-contact style. The dimensions of the energy indicator are 0.019 "high and 0.024" wide. This results in a cross-sectional area of 0.00023 square inches. The width of the weld surface is 0.075 ", resulting in a weld volume of approximately 0.003" x 0.075 ". This 0.003" weld volume should be considered when determining the geometry of the assembled part. Vessels are provided in the weld geometry to prevent entrapped gas from being contained through the welds to create a poor weld that may leak. An alignment hole is provided in the back cover for assembly purposes to ensure that the back cover is precisely aligned to the mid-body during the ultrasonic welding process. Alignment holes in the back cover also provide precise alignment of the manifold and instrument when properly loaded. The raised protrusions around the alignment holes are designed to maximize contact with the alignment pins of the welding fixture such that the plastic is not easily melted due to friction. These projections do not contact and are not welded, so that the holes are clear.

Ultrasonic welding is chosen as the method for combining the manifolds of the three major components due to the low cost of this manufacturing process. The relatively low device cost and cycle time to create the weld contribute to this less production cost. Once the part is loaded in the fixture, the weld cycle due to horn movement and removal can be achieved in a matter of seconds. The actual welding time is about 1 second. Other bonding methods include hot plates, lasers, and UV adhesives.

31, in one embodiment, the middle-body portion 3100 includes three two-way valves 3107, five pressure transducers 3106, an occlusion detector, an air bubble detector, and a blood leak detector . Those skilled in the art will appreciate that the number and type of functional components incorporated within the intermediate-body portion 3100 can vary according to the requirements and use of the blood purification system, and accordingly, can be 1, 2, 3, 4, 6, 7, 8, 9, 10 or more pressure transducers, 1, 2, 4, 5, 6 or more 2-way valves, 0, 2, 3, 4 or more occlusion detectors, 0, 4, or greater, air bubble detectors, 0, 2, 3, 4 or more blood leak detectors. In addition, the mid-body portion 3100 includes a plurality of ports 3103 and 3104.

The ports include an internal port 3104 through which fluid flows from the first and second segments of the manifold 3100 and between the pump segments (not shown) therebetween. In one embodiment, the first segment has four internal ports 3104, two of which are on each side of the first segment and the point at which the connection segment is connected. It should be appreciated that the first segment may have 1, 2, 3, 5, 6, 7, or more internal ports. In one embodiment, the second segment has four internal ports 3104, two of which are on each side of the point at which the first segment and the connecting segment are connected. It should be appreciated that the second segment may have 1, 2, 3, 5, 6, 7, or more internal ports. Additionally, it is desirable that the location and location of the interior port of the first segment be mirrored with the location and location of the interior port of the second segment. The port also includes an external port 3103 for external components to the manifold 3100. In one embodiment, the first segment has two external ports 3103. In one embodiment, the second segment has ten external ports 3104. In one embodiment, the first segment has 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or more external ports 3103. In one embodiment, the second segment has 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, or more external ports 3104.

Integrating the fluid contact component into the manifold, as described above, allows the design of a system in which a reuse sensor is mounted to the dialysis machine, with the manifold coupled to such a dialysis machine, Separated and placed in the manifold. In order to ensure that proper readings and measurements are made, the fluid contact component and the reuse sensor need to be aligned. The coupling and alignment between the manifold and the dialysis machine is important with respect to the orientation and the applied pressure. Typically, such coupling accuracy should provide 0.001 " to 0.010 "tolerance in the X, Y, and Z directions and apply mounting forces in the range of 10-100 PSI to counteract the fluid forces by the manifold. Such critical positioning is accomplished by a specifically designed orthotropic surface on the manifold that is registered with the complementary orthotropic surface on the dialysis machine. The desired force is delivered by design and analysis of the dialysis machine structure to permit X and Y position and Z deflection of less than about 0.001 "to 0.010" under all fluid and mechanical pressures deployed in the manifold during operation. Since the manifold contains many structures on a single monolithic substrate, such critical alignment needs to be performed only if all features of the manifold are aligned with all the binding features of the dialysis machine.

The mid-body channel size is nominally 0.190 "deep, 0.190" wide, and 0.020 "radius at the lower corner of the channel on the mid-body side. The radius at the lower corner of the channel is maximum, These channel walls have valves and pressure barrier geometry on opposite sides of the mid-body, which walls can be adversely affected by sinks in these areas. In one embodiment, The general design rule for preventing sinking is that the wall thickness of the rib (in this case the channel wall) should not exceed 50 to 60% of the adjacent wall to which the lip is attached. And the adjacent wall (main manifold structure) is 0.130 ", resulting in 58%. The 0.190" x 0.190 "dialysate channel is transitioned through the hole to the 0.155" tube port. This minimizes the accuracy required for aligning the front cover to the mid-body and minimizes the potential for sinking caused by thicker walls that may affect sealing the feature on the opposite side of the mid-body. The same method is given to the anticoagulant and infusion channel. A gentle curve is designed into the channel to maximize stratified flow and minimize vortex flow. In one embodiment, as discussed below, the anticoagulant and infusion channel are measured at 0.190 "depth and 0.100" width.

In one embodiment, the mid-body has an alignment hole for assembly purposes such that both the front and rear covers are precisely aligned to the mid-body during the ultrasonic welding process. The raised protrusion around the alignment hole maximizes the contact of the welding fixture with the alignment pin so that the plastic is not easily melted due to friction. These protrusions are not contacted and welded, thereby making the hole clear.

33 is a view for explaining a fluid circulation path for a compact manifold according to an embodiment of the present invention in detail. The fluid circuit is connected to four pump tube segments P1 (3301), P2 (3302), P3 (3303) and P4 (3304) in pressure communication with the pump in the upper controller unit and pump shoes ). Which in turn is connected to the five pressure membranes in pressure communication with the pressure sensors S1 3305, S2 3306, S3 3307, S4 3308 and S5 3309 and the temperature sensor S6 3310, And includes areas that are in an optical communication relationship. In the embodiment illustrated in Figure 33, three pairs of membranes V1A and V1B 3311, V2A and V2B 3312, and V3A and V3B 3313 are integrated into the manifold. The membranes function as valves when they are plugged by pins, members or protrusions from the controller unit.

When the group is formed in this manner, six one-way valves 3311 A, 3312 A, 3313 A, and 3312 A form three three-way valve assemblies 3311, 3312 and 3313. Two-way valves provide greater flexibility in controlling the construction of the circulation path. When conventional two-way valves are used to occlude a portion of a fluid path, they typically have two different fluid paths, one for the first valve state and one for the second valve state Lt; / RTI > Certain valve embodiments that are used in combination with a valve membrane or pressure point incorporated into a manifold as described below enable more subtle control to enable the generation of four distinct fluid channels.

Pump tube segments 3301, 3302, 3303, and 3304 are coupled into the compact manifold. Many ports are provided in the manifold, which are connected to the tubes outside the manifold to allow a variety of fluid flow into and out of the manifold. These ports are connected to various tubes in a blood purification system to deliver fluids as follows:

Port A 3315 - connecting blood to the dialyzer 3330;

Port B (3316) - connected to the dialyzer outlet (used dialysis);

Port C (3317) - connection to blood from the patient;

Port D (3318) - connection to heparin for mixing in blood;

Port E (3319) - Connect to reservoir outlet (fresh dialysate);

Port F (3320) - Connect to the dialyzer inlet (fresh dialysate);

Port G (3321) - Connect to the dialyzer outlet (blood);

Port H (3322) - Connect to patient return (clean blood);

Port J (3323) - to prime and drain lines;

Port K (3324) - connected to the reservoir infusion inlet;

Port M (3325) - connection to the infusion fluid from the infusion reservoir;

Port N (3326) - Connects to the dialysate flow into the adsorbent.

In one embodiment, the tube segment formed as a path formed into the manifold structure 3300 includes a fluid flow of heparin 3314 entering through port D 3318 to a fluid flow of blood entering port C 3317 Lt; / RTI > The mixed heparin and blood flow through the port 3317a and into the port 3317b of the manifold 3300 via the pump segment 3301. The pressure transducer is in physical communication with the membrane 3305 formed in the manifold structure 3300 and then such membrane passes blood and heparin fluid through port A 3315. [ The fluid flow out of the manifold 3300 at port A 3315 passes through the catapult 3330 outside of the manifold 3300. The dialyzed blood passes through the port G 3321 back into the manifold 3300 and into the segment 3307 formed as a shaped path in the manifold structure 3300 in physical communication with the pressure transducer. The fluid then passes through the port H 3322 into the patient return line from the segment.

Separately, the dialysis fluid enters the manifold 3300 from the reservoir via port E (3319). The fluid in the reservoir has an infusion fluid therein which first enters the manifold 3300 via port M 3325 and through a segment formed as a path formed into the manifold structure 3300, Through the port 3325a, through the segment 3302 in communication with the pump, and again through the port 3325b into the manifold 3300. The injection liquid passes through a segment formed as a path formed into the manifold structure 3300 and exits the manifold 3300 at port K 3324 and passes into the reservoir thereat via port E 3319 The dialysis fluid entering the manifold passes through a segment formed as a path formed into the manifold structure 3300, through another port 3319a, through a segment 3303 in communication with the pump, 3319b to pass into the manifold 3300.

The dialysate fluid passes into a segment formed as a path formed into the manifold structure 3300 in physical communication with the pair of valves 3311. [ A segment formed as a shaped path into the manifold structure 3300 passes the dialysate fluid through another pair of valves 3313. Such a segment is in physical communication with pressure transducer 3308 and optical temperature sensor 3310. The dialysate fluid is passed through port F 3320 into a line that exits manifold 3300 and passes into the dialyzer 3330.

The line exiting the dialyzer 3330 passes fluid again through port B 3316 into the manifold 3300 and the first pair of valves 3311 and the second pair of valves 3312 and the pressure transducer 3306 Into a segment formed as a shaped path into the manifold structure 3300, which is in physical communication with the manifold structure 3300. The used dialysate fluid exits the manifold 3300 through port 3326b, passes through segment 3304 in communication with the pump, and again passes through port 3326a into the manifold. The segment in fluid communication with port 3326a is in physical communication with pressure transducer 3309 and passes fluid through port N 3326 to the adsorbent recovery system.

Such ports are designed for circulating tube 0.268 "x 0.175" tubes or anticoagulant and infusion tube 0.161 "x 0.135 ". Preferably, the tube port is combined with a suitable solvent.

It should be appreciated that the valves 3311, 3312, 3313 shown in Figure 33 may be positioned at different locations within the manifold. Referring to Figure 86, valve 8611 (valve 3311 in Figure 33) is adjacent to and parallel to valve 8612 (valve 3312 in Figure 33) to a central vertical portion of manifold 8600 Lt; RTI ID = 0.0 > 8650 < / RTI > On the central vertical portion 8650 of the manifold 8600 connecting the upper horizontal portion 8630 and the lower horizontal portion 8640 together, there is a valve 8613 (valve 3313 in Fig. 33). Valve 8613 is on the bottom of central vertical portion 8650 and is positioned substantially underneath valves 8611 and 8612 and is in the middle between them.

In one embodiment, the two-way valve operates by having a valve actuator mounted on the instrument, and presses the elastic diaphragm on the spout seal, as described in further detail below, to produce a dialysate flow through each path . The spray seal opening is approximately 0.190 "in diameter and matches the channel geometry. The cross-sectional path through the interior of the valve is at least equivalent to a 0.190" diameter when the valve is open. When the valve is in the closed position, the valve actuator and resilient diaphragm consume most of the fluid path space around the spout seal to minimize the potential for air trapping. There is a mid-body raised plastic feature that not only minimizes dead space in the fluid path, but also helps to prevent the diaphragm from collapsing around the central fluid path under negative pressure conditions. The elastic diaphragm has o-ring features around the periphery that fit into the grooves on the mid-body surface. The o-ring is pressed between the mid-body and the back cover to form a fluid tight seal. A design is provided for approximately 30% compression on the o-ring. A two-way valve controls the direction of the dialysate flow through the manifold.

The manifold contains a structure that allows fluid pressure to be monitored across the diaphragm through the use of sensors within the instrument. Fluid is allowed to flow from the channels on the mid-body front cover side through the inlet and outlet openings below the diaphragm on the back cover side. The cross-sectional path through the interior of the pressure sensing structure is equivalent to at least 0.190 ". The internal passageway is designed to minimize air entrapment while providing sufficient fluid contact with the diaphragm. The o-ring is pressurized between the mid-body and the back cover to form an oil tight seal. A design for 30% compression on the o-ring is provided.

Valves and diaphragms may be manufactured from a variety of different materials by different processes. In one embodiment, the elastic component is fabricated from silicon. In yet another embodiment, the elastic part is made from various thermoplastic elastomers. Two shot molding can be used to attach the valve and diaphragm to the back cover. Two-shot shaping of the valve and diaphragm will eliminate the need to individually assemble these components into the manifold, thereby reducing labor costs and improving the quality of the manifold assembly.

The pumping component in the manifold design is defined as PVC header tubing. These headers, in combination with the instrument's rotary linked pumping system, provide a flow of blood, dialysate, and infusion fluid. Circulating tube materials for dialysis, infusion and anticoagulant are preferably tubes referred to as torture resistant materials such as Colorite, Unichem PTN 780 (80A durometer) extruded by Natvar and all TEKNIplex companies. The tube dimensions for the dialysis water line range from 0.268 "x 0.189" to 0.268 "x 0.175".

In order to make the manifold segments thermal, optical or pressure communication with the one or more sensors through the elastic membrane, it is important to create sufficiently close exposure of the fluid flow to the sensing device. One way to do so is shown in FIG. Manifold segment 3400 receives fluid flow 3410 that is caused to move upward due to the blocking and redirecting position of protrusions, members, or other structures 3408 in fluid path 3410. The fluid moves upward and is concentrated between the membrane 3405 and the structure 3408 to enable improved sensing. Such an embodiment, however, can be used to create blood clotting, resulting in bend 3401, 3415, or due to adhesion of the base 3406 of the membrane 3405 to the upper portion 3407 of the structure 3408 due to negative pressure. There is a potential for occlusion.

Now, referring also to FIGS. 35A and 35B, in order to minimize the potential of the helicase solidification or occlusion, one or more sensors, via the elastic membrane 3505, also referred to as sensing segments, and a thermal, While the structure of the associated manifold segment 3500 avoids creating a sharp redirection, bend, or U-shaped path that may increase the likelihood of solidification or occlusion, It is desirable to be designed in such a way that it still provides sufficient contact between the sensors located thereon. 35A and 35B, the inner fluid path 3515 is determined by the upper surface and the lower surface, which is in thermal, optical, or pressure communication relationship that occurs through path 3515, A lower surface comprising a) a first upward inclined wall 3525 which reduces the height of the path 3515 from a first height to a second height along the length of the wall 3525, b) a flat segment 3526 that maintains the same path height 3515 at the second height, and c) a height 3515 of the path 3515 that crosses the length of the wall 3527 from the second height to the first height Is determined by the downward inclined wall 3527. The angled upward tilting / downward tilting of the walls 3525, 3527 narrows the fluid path 3515. However, at the same time, the width of the segment defined by the angled walls 3525, 3527 and the flat segment 3526 is wider than that of the manifold portion before and after this sensing segment. The height reduction and width increase of the sensing segment relative to the manifold segments before and after the sensing segment provides a substantially constant rate of fluid thereby avoiding velocity variations that can hemolyze the blood, eliminate dead space, While still providing the necessary contact area for the flexible membrane 3505 in which the sensor performs the measurements. In one embodiment, one or more posts 3535 are integrated into the fluid path 3515, on the flat surface 3526, and under the membrane 3505 to prevent complete collapse of the membrane 3505 due to negative pressure.

As can be appreciated from the above discussion, the blood and dialysis circuit of the manifold can be defined by a single piece of molded plastic rather than a plurality of plastic parts being welded together. However, certain problems arise when the blood and the dialysis circuit are defined by a single individual part of the material. In particular, the ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b in Figure 33 may be configured such that a cylindrical projection defining each port extends directly vertically from the manifold surface, If the angle is substantially 0 degree from the side of the portion of the manifold to which the cylindrical projection is attached, there is a problem in cost-effective and easy molding. If the port is made in a fully vertical configuration, the pins from the molding machine can not be easily removed. 33 and 36, a cylindrical protrusion defining the port structure 3655 may be formed on the manifold 3645 side to which such protrusion 3655 is attached, as determined by surface 3675 It may be desirable to fabricate the ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b by forming the angles. Thus, in one embodiment, the internal manifold port will be at a constant angle to the manifold surface. This angle further reduces the stress on any pump tube segment that is inserted between the two angled ports. This further places the pump tube segment in a somewhat curved vent, or otherwise non-linear shape, to better conform to the pump header contact surface. In one embodiment, the angle defined by the line perpendicular to the center of the angled port and the line perpendicular to the manifold side is less than 20 degrees, preferably less than 10 degrees. In one embodiment, the angle is approximately 10 degrees. In one embodiment, the internal manifold ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b are fabricated at the aforementioned angles, while the remaining ports are approximately the same angle to zero. In another embodiment, as shown in Fig. 37, the projecting portion 3655, which is described as cylindrical, has an inner region or space 3753 in which the base 3754 is substantially planar Although not bent, the remainder of the internal structure that defines space 3753 is flexed (3756). In yet another embodiment, all ports or fluid paths have an interior region or space 3753 in which the base 3754 is substantially planar and unbent.

Another embodiment of the manifold is shown in Figures 38-40, in which the blood and dialysate channels are molded into a single compact plastic unit. In one embodiment, the manifold 3800 is easy to assemble a compact plastic unit having a built-in molded blood and waste flow path. Optionally, the sensor, pump and blood filter cartridge may also be integrated with the compact plastic unit by insertion into the recessed mold in the unit. In one embodiment, the dialysis system of the present invention can be operated continuously for more than 8 hours per treatment, and up to 72 hours. It should be appreciated that the fluid flows through the defined inlet and outlet ports, e.g., into and out of the external pump, into the waste UF reservoir, or into the patient return line.

Figure 39 shows the module assembly of the manifold 3900 in one embodiment of the present invention. Pumping section 3930 includes blood and waste pumps 3903 and 3913, respectively. Module 3940 includes a blood filtration module 3950 that includes a formed flow path 3942 and a blood filtration cartridge 3908 for blood and ultrafiltration wastes. Such modular design allows for quick and easy assembly of various modules into a single compact structure.

FIG. 40 shows an enlarged view of the middle-body module 3940 of FIG. In one embodiment, the intermediate-body module 4040 includes a built-in formed flow path 4041 for conveying blood and waste. Body module 4040 is also connected to the pump at one end of the mid-body module 4040 and to the hemofiltration cartridge at the other end of the mid- Molded into a module.

38, the blood is guided into the manifold 3800 through the blood inlet port 3801 and the formed flow path 3802 using a blood metering pump 3803 in pressure communication with the manifold tube segment. do. The blood metering pump 3803 pumps blood through the formed flow path 3804 into the blood filtration cartridge 3808. The inlet pressure sensor areas 3806 and 3807 are also integrated into the manifold 3800 with formed flow paths 3802 and 3804.

38, waste from the permeate portion 3809 is discharged by the waste metering pump 3813 through the formed flow path 3814, which in one embodiment is connected to the flow path 3814 And has an integrated pressure sensor area 3815 located in-line. Waste is pumped through the formed flow path 3816 which in one embodiment exits the manifold 3800 through the waste discharge port 3819 and forms an integrated blood A leak detector area 3817 and a waste flow meter 3818.

In one embodiment, the blood filtration cartridge 3808 is disposable and can be detachably integrated into a corresponding molded recess in the manifold 3800 to complete the ultrafiltration cycle. Manifold 3800 also provides an interface to the surplus pinch valve to prevent air from entering the vasculature of the patient. The pinch valve is designed to be in the closed (closed) position when no power is applied.

The shaped channels 3802, 3804, 3810, 3814 and 3816 define the blood and ultrafiltrate flow circulation path of the manifold 3800. In one embodiment, these channels include a disposable tube and a plurality of interfacing components, such as a joint suitable for contacting blood and ultrafiltrate for more than three days. Such joints are preferably at least 5 lbs. Strength and a seal to 600 mm Hg (i.e., greater than blood filtration maximum dermal pressure). In one embodiment, the blood set tubes corresponding to the flow paths 3802, 3804 and 3810 have a length and an inner diameter suitable for supplying a blood flow of 50 ml / min. In one embodiment, the initial volume of the blood set tube, including the blood filter, is less than 40 ml. The blood set tube is interfaced with the blood metering pump 3803. The blood pump 3803 tube consists, in one embodiment, of the Tygon brand formulation S-50-HL, size 1/8 "ID x 3/16" OD x 1/32 "wall.

Similarly, in one embodiment, an ultrafiltrate set tube corresponding to the flow paths 3814 and 3816 can provide an ultrafiltrate flow of 500 ml / Hr (8.33 ml / min). The ultrafiltrate set tube is also interfaced with a waste dosing pump 3813. The waste metering pump 3813 tube is, in one embodiment, a Tygon brand formulation S-50-HL, size 3/32 "ID x 5/32" OD x 1/32 "wall.

Since the manifold of the present invention includes a blood flow, a dialysis fluid, a waste fluid, and a formed flow path for a makeup fluid, the entire flow path can be easily manufactured as a portable complex manifold. The manifold is also easy to handle because all the flexible tubes outside the manifold are attached on one side of the manifold. The use of manifolds with built-in formed flow paths improves fail-safe treatment because changes in disconnection, misassembly, and leakage can be avoided with conventional Because it is minimized compared to the technology system. The use of the manifold of the present invention also improves ease of use and improves portability.

In one embodiment, the dialysis manifold is a stand-alone compact unit, allowing them to be used separately and separately to treat blood from the patient. In another embodiment, the two manifolds may be connected to one another and function as a dual stage blood treatment system. In one example, blood is drawn from the patient's arterial site and passes through the dialyzer, where a large amount of waste fluid is convected. The manifold is used to return the same amount of fluid back to the blood before the blood is reinjected. The manifold weighs the waste fluid and discards it into the waste bag.

As is known to those skilled in the art, a hemofilter, or dialyzer, cartridge 3808 includes a hollow tube that additionally includes a plurality of hollow fiber tubes whose walls act as a semipermeable membrane. The plurality of semipermeable hollow fiber tubes divide the blood filtration cartridge 3808 into a blood flow portion 3805 in the hollow fiber tube and a filtrate or permeate portion 3809 outside the hollow fiber tube. As the blood passes through the blood site 3805, plasma water passes across the semipermeable membrane of the hollow fiber tube. The blood filtration cartridge 3808 is a small blood filter. More concentrated blood flows out of the cartridge 3808 through the formed flow path 3810 and flows out of the manifold 3800 through the blood discharge port 3811. [ The air detector area 3812 is also integrated into the blood conveyance passage 3810.

The following description is an exemplary physical detail of a hemofilter, or dialyzer, 3808, according to one embodiment of the present invention:

During the dialysis process, the patient or health care provider installs one of the manifolds described above on the dialysis machine. 41, the dialysis machine 4101 has a front door 4103 which can be widely opened to install a disposable part. For installation, the manifold 4104 simply needs to be inserted into the purposefully provided space in the dialysis unit 4101, as discussed above. Installing the dialyzer 4102 also includes simple insertion at the designated receses. The front door 4103 is provided with a pump shoe 4105 which makes it very easy to load the disposable part as the pump tube is not required to escape between the roller and the pump shoe. In addition, this arrangement makes it possible to install dialysis 4102 and manifold 4104 in a manner that ensures proper alignment of non-disposable parts, e.g., pressure readers, sensors and other components. This packaged, simple method enables easy disposable article loading and cleaning of the system. This also ensures that the flow path is properly configured and ready for use.

42, in one embodiment, the manifold 4202 is mounted on the vertical front panel 4203 of the dialysis system 4201. The manifold 4202 is accurately positioned on this panel 4203 by a plurality of alignment mechanisms. The first alignment mechanism includes a plurality of alignment pins within panel 4203 that engage alignment holes in manifold 4202. The second alignment mechanism includes one or more latches that hold the manifold 4203 in a specially mounted position until the door 4206 is closed and a final correct position is obtained. In one embodiment, the back cover of the manifold 4202 has two designed-in tabs on the top and bottom. These tabs lock the manifold 4202 in the first locked position before the door 4206 is closed and the subsequent placement of the correct position of the manifold 4202. These tabs enable a locking mechanism that can be released by a ball detent that requires manual disengagement or forced removal of the manifold 4202 by hand. In yet another embodiment, the locking mechanism may include a spring loaded insertion and release mechanism at the top of the back cover. This mechanism has a connecting rod between the upper latch and the lower latch. When the release mechanism is activated at the top, the lower latch is also released.

The third alignment mechanism includes a contoured guide 4208 that leads to the general position and shape of the manifold 4202. Such a concha guide 4208 is preferably configured to mate, match, or otherwise complement the physical structure of the manifold 4202. In one embodiment, the guide 4208 is generally rectangular and is configured to fit within a space defined by the first segment, the second segment, and the connecting segment side of the manifold 4202, as described above have. The fourth alignment mechanism includes a door 4206 having one or more spring loaded pressure plates 4205 that secure the manifold 4202 between the door 4206 and the front panel 4203, And pressure sufficient for pressure sensing. The door 4206 also includes four pressure shoes that apply sufficient pressure to the pumping component for rotationally interlocking the fluid.

It should be appreciated that one or more of the alignment mechanisms may be used alone or in combination to achieve the alignment and pressure position required for the manifold. In addition, it should be appreciated that the alignment mechanism is coupled to the surface of the recessed area in the dialysis device enclosure. The recessed region includes a front panel 4203, which is recessed relative to the dial unit housing and is bounded by four walls (a first wall, a second wall, a third wall and a fourth wall) Which wall extends upwardly from the front panel 4203 and meets and is fixedly coupled to the dialysis device enclosure. The recess is sufficiently deep and configured to receive the door 4206.

Sensing system

As mentioned above, the dialysis system, and in particular the upper controller unit, interacts with the portion of the manifold, in particular with the transparent portion of the membrane incorporated in the manifold or manifold structure, to determine certain parameters or conditions such as flow rate, , The presence of sodium, the presence of ammonia, pH levels, blood leaks, occlusion or air bubbles. For example, detection of blood leaks, air bubbles, and / or occlusions is achieved by including an optical sensor in a dialysis machine attached to and around a predetermined area of the manifold. The manifold may include a plurality of tube support gratings that facilitate the precise positioning of the circulation tube into an optical sensor, such as an Optek sensor, which is separately mounted in the installation when the manifold is installed and the door is closed . The sensor provides a means for detection of occlusion in the arterial line, detection of blood leakage in the blood line downstream of the dialyzer, and means for detecting air in the venous blood line. The bracket holds the tube on one side of the sensor, and the tube port holds the other side of the sensor. These optical sensors are U-shaped devices, and when the manifold is installed, the tube is forced into such a device. The tube support brackets support the tube so that all three of these sensors are loaded in the same motion as the manifold load without additional effort on the user side. Among other systems, a detection system for flow rate, temperature, disconnection, and central venous pressure is further described below.

flux

In one embodiment, the dialysis system is a non-invasive or non-contact type having the ability to generate acoustic signals directly from the fluid being monitored without physical contact and to provide flow measurements with improved accuracy based on sonar transit time And an acoustic wave flowmeter. It is further contemplated that the present flow meter may be used in conjunction with one of the manifolds described above to non-invasively measure the flow in the manifold.

43 is a circuit diagram showing an exemplary photo-acoustic flow meter 4300. Fig. Fluid 4304 through which the flow rate is to be measured is conveyed by fluid-support path 4305, e.g., a pipe, tube, or manifold segment, in the direction indicated by arrow 4306. The optical-acoustical pulse flow meter 4300 includes a light emission system 4310. In one embodiment, such system 4310 further includes an LED or solid state laser 4307, which is excited in a sinusoidal manner by signal source 4308. [ In another embodiment, a Q-switched ruby laser may be used in place of the system 4310. Those skilled in the art will recognize that any other suitable light generating system known in the art may be used for this purpose.

Light generating system 4310 projects beam 4309 onto fluid 4304 through an optical aperture, or optically transparent section, formed in the wall of path 4305 (i.e., the manifold segment). In one embodiment, the projected optical beam 4309 traverses through fluid 4304 in a direction perpendicular to the direction of axis 4312 of fluid-support path 4305. The optically transparent section of the tube 4305 should be transparent to a specific wavelength of the optical source 4310. The wavelength of the optical source 4310 should be chosen such that the light is easily absorbed by the system by the fluid 4304 to be measured by the flow rate. In addition, when the system 4300 is used with a manifold, the light generating system 4310 is preferably contained in a dialysis machine, the disposable manifold is loaded into such a dialysis machine and aligned with the manifold It should be appreciated that the optical beam 4309 is allowed to pass through the transparent section of the manifold.

As the optical beam 4309 passes into the fluid 4304, the thermal energy associated with the optical beam is absorbed into the fluid. Absorption of heat occurs along the direction of the beam 4309 and causes thermal variations in the fluid 4304. These thermal variations appear as ubiquitous fluid heating and cause thermal expansion within the fluid. As a result of this thermal expansion, a sound signal 4311 is generated. The nature of this signal, which is related to the pressure change in the fluid 4304, simulates the waveform generated at the signal source 4308 used to power the optical signal generating element 4307. This pressure change is propagated both upstream and downstream in relation to the position of the optical beam 4309 in path 4305.

As is known to those skilled in the art, acoustic signals received upstream and downstream by sensors 4313 and 4314, respectively, will out of phase with each other. The amount of phase difference between the acoustic signals received upstream and downstream is directly proportional to the flow rate. In addition, when used with a disposable manifold, it should be appreciated that sensors 4313 and 4314 are either positioned close to the manifold tube or embedded within the manifold tube.

Thus, in one embodiment, the sound detectors T1 4313 and T2 4314 are positioned upstream and downstream, respectively, equidistant from the optical beam 4309 such that d1 4313a and d2 4314a are equal. In another embodiment, the positions of the upstream and downstream 4313 and 4314 need not be equidistant from 4309. Detectors T1 and T2 may be pressure transducers or acoustical transducers, e.g., microphones. Microphone cartridges, such as Model WM-55A103 manufactured by Panasonic Corporation, are suitable for this application.

Detectors T1 4313 and T2 4314 illuminate the fluid flow to detect acoustic signals 4311 at the points where detectors T1 4313 and T2 4314 are located. As the pressure change (sound) of the acoustic signal 4311 is transmitted to the sensors 4313 and 4314 through the wall of the circulation path 4305, the irradiation occurs acoustically.

A first receive amplifier 4315 is coupled to detector T1 4313 and a second receive amplifier 4316 is coupled to receive the output from detector T2 4314. [ The outputs of the first and second amplifiers 4315 and 4316 are connected to the inputs of the first and second phase sensitive detectors 4317 and 4318 via gain control elements 4319 and 4320, respectively. One implementation of the phase sensitive detectors 4317 and 4318 is known in the art as a "lock in amplifier ". After the signal is processed by the amplifiers 4315 and 4316 and the phase sensitive detectors 4317 and 4318, the outputs of 4317 and 4318 pass through low pass filters 4321 and 4322 to produce a high frequency noise component Or the ripple remaining from the phase detection detection process 4324 is removed from the signal. The resulting output of the filters 4321 and 4322 are normal signals representing the relative phase of the acoustic signal detected by 4313 and 4314, respectively, with respect to the original signal of the generator 4308. [ Thus, the photo-acoustic flow meter provides an indication of the phase angle of the upstream and downstream acoustic signals, in relation to the reference signal.

After processing and phase detection by the phase sensitive detector component, the upstream and downstream phase angle signals are supplied to the add / subtract unit 4323. [ The output of the addition / subtraction unit 4323 represents the phase difference between the upstream received sound signal by the sound detector T1 4313 and the downstream received sound signal by the sound detector T2 4314. This phase difference between these acoustic signals is directly proportional to the flow rate of the fluid and can be used as a basis for calculating a substantial flow rate or a change to such flow rate, as will be appreciated by those skilled in the art. All means for calculating the flow rate include a processor and a software algorithm for deriving a change in flow rate or flow rate from at least the phase difference data. Thus, the output of the add / subtract unit 4323 provides a flow measurement of the fluid 4304.

Thus, as described above, in one embodiment, the output voltage signals of the first and second low-pass filters 4321 and 4322 are sampled and subtracted in unit 4323 to determine the flow rate of the fluid in path 4305 Is determined. Those skilled in the art will appreciate that any other suitable means for calculating the phase difference from the output of the sound detector may be used. All such means include a processor for calculating the phase difference and a hard code or soft code software algorithm.

As previously mentioned, the signal generated by the source 4308 acts as a reference signal for the upstream and downstream transducers T1 4313 and T2 4314. Figure 44 shows the reference signal 4400a generated by the source 4308 of Figure 43. 44 shows respective acoustic wave signals 4400b and 4400c after progressing signal processing in the output of the gain control amplifiers 4315 and 4316 of Fig. 43, respectively.

In one embodiment, a photoacoustic pulse flow meter can be used by those skilled in the art to non-invasively monitor the flow rate of fluid in known dialysis systems, such as hemodialysis, hemofiltration and / or hemodialysis filtration systems. The fluids required to measure the flow rate during dialysis are mainly blood and dialysate in the blood and dialysate circulation channels, respectively; Those skilled in the art will appreciate that the flow rates of other fluids, such as infusion fluids or concentrates, may also be measured by the flow meter of the present invention. Those skilled in the art will also recognize that the flow meter of the present invention may also indicate the presence of flow non-flow in the circulation path / path.

Thus, referring again to FIG. 43, if the difference between the signal outputs of the low-pass filters 4321 and 4322 is meaningless, this would imply no flow of fluid. In dialysis system applications, this detection of fluid non-flow is very useful because it may be an indication of a serious problem such as disconnection of the arterial / venous catheter connected to the patient.

In yet another embodiment, the flow in the manifold can be measured by a thermal flow meter. 56 illustrates a thermal fluid flow measurement apparatus 5601 of the present invention installed with a manifold 5602 in a dialysis machine 5610. As mentioned above, the manifold 5602 has a fluid flow path or tube circulation path 5603 embedded therein. The dialysis machine 5610 has a front door 5620 that can be opened to install the disposable manifold 5602. In addition, the front door 5620 is equipped with a pin 5621 that can contact the electrical point on the manifold 5602 to read information or provide electrical input when the door 5620 is closed.

The thermal fluid flow measurement device 5601 further includes a series of contacts 5611, 5612, and 5613. Operatively, as fluid (e.g., blood, dialysate, or other fluid) flows through the fluid channel 5603 during dialysis, it passes through a first contact portion 5611 that is embedded in the plastic path. Contact portion 5611, in one embodiment, makes electrical contact with an electrical source, which is pin 5621 on machine front door 5620. The electrical source or pin is controlled by a controller in the dialysis machine 5610. The electrical source supplies an electrical stimulus to contact portion 5611, which acts to micro-heat the contacts based on a sine-wave method.

In one embodiment, the micro-heating process causes a temperature rise of 0.1 to 1.0 占 폚 in the fluid being measured. This temperature rise is caused by the microwave heater located at the first contact portion 5611, and such a heater generates heat upon reception of the electrical stimulus. The microheater for the thermal fluid flow measurement device of the present invention can be fabricated using any design suitable for application. For example, in one embodiment, the microheater is made of 30 grams of copper wire wrapped around a pin located at the first contact position 5611.

As the contact portion 5611 is micro-heated, the generated thermal energy acts to generate a thermal wave, and such thermal wave propagates downstream from the first contact portion 5611. A plurality of contacts, in one embodiment, two contacts 5612 and 5613, are located downstream from the first contacts 5611 and are used to measure the propagation time of the heat waves. Then, the measured time of such wave is compared with the initial wave generated by the first contact portion 5611. The measured retardation provides an indication of the flow rate.

Figure 45 illustrates one embodiment of a flow meter 4500a having probes that can be used for flow measurement. The channel 4501a includes a space 4502a through which a fluid such as a water or silane solution (0.9N) 4503a flows. In one embodiment, the channel has a height in the range of 1 mm to 5 mm (preferably 3 mm), a width in the range of 3 mm to 13 mm (preferably 8 mm), a range of 10 mm to 100 mm Length, a channel area in the range of 3 mm ² to 65 mm ² (preferably 24 mm ² ), and / or a hydrodynamic diameter in the range of 1.5 mm to 7.22 mm (preferably 4.36 mm).

The flow direction of the fluid is shown by arrow 4504a. An excitation probe 4505a is positioned close to the reception probe 4506a. The relative distance of the probes is an important feature of the design because the excitation frequency at which the electrical stimulus should be transmitted by the excitation pin or probe 4505a depends on the distance between the probes 4505a and 4506a. In one embodiment, the excitation probe and the receive probe are located at a distance of less than 2 inches, preferably less than 0.8 inches, more preferably approximately 0.6 inches, or approximately 15 mm from each other. In this embodiment, the excitation and measurement require only two contacts, each contact having a contact surface 4507a. Those skilled in the art will appreciate that in such cases only two contact points will be required than three, as indicated above in connection with the disposable manifold and the dialysis machine.

The excitation pin or probe 4505a is embedded in the channel 4501a and acts to provide a thermal stimulus (in the form of a thermal wave) to the flow fluid which is then sensed and measured by the receive probe 4506a. In one embodiment, the body diameter of the pin or probe is in the range of 0.03 inches to 0.15 inches (preferably 0.08 inches) and the diameter of the upper contact surface is in the range of 0.025 inches to 0.2 inches (preferably 0.125 inches) Or the probe is made of gold plated brass or any other material having a density of approximately 8500 kg / m ³ , a thermal conductivity of approximately 1.09 W / mK and / or a specific heat of approximately 0.38 J / KgK.

In one embodiment, the body of both the excitation pin or probe 4505a and the receiving pin or the probe 4506a is molded into the manifold (so that the pin or probe is not in physical contact with the fluid, Is exposed to one surface of the manifold). The body of the pin or probe is in the center of the cell and the fluid passes through it. The top of the pin is exposed to allow the spring loaded contact from the instrument panel to be in thermal contact so that thermal energy is transferred between the spring loaded contact and the contact surface of the pin.

45, a side view of one embodiment of a thermal flow meter 4500b of the present invention is shown with a contact surface 4507b, which is located on the instrument panel of the dialysis machine (shown in FIG. 56) Is exposed so that thermal energy can be exchanged between the spring loaded contacts and the excitation pin or probe 4505b. The channel 4501b includes a space 4502b through which the fluid 4503b flows. The direction of the fluid flow is shown by arrow 4504b. The excitation probe 4505b is located close to the receive probe 4506b, each of which has a contact surface 4507b.

Figure 45 further shows a thermal flow meter 4500c from the end of flow channel 4501c including a space 4502c through which fluid 4503c flows. Here, only the receiving probe 4506c and its contact surface 4507c are shown. In one embodiment, the receiving contact or pin 4506c has a structure similar to that of the excitation pin 4505b, and its top portion 4507c is also exposed. In one embodiment, the receiving pin surface 4507c is also designed as a low thermal capacity spring loaded contact. The receive (4506a) probe or pin as well as excitation (4505a) are made of a suitable material having high thermal and electrical conductivity, and in one embodiment, it is a gold plated brass.

In one embodiment, the low thermal capacity spring loaded contacts within the instrument, such as a dialysis machine, are temperature controlled using a heater and a thermistor. The temperature control function then creates a cosine temperature wave form in the probe that reflects the temperature wave generated at the spring loaded contacts. The generated excitation signal characteristics of the excitation pin can be defined as follows:

e _s = E _s cos ( ωt ), where ωt is the excitation frequency.

The thermal response of the receiving pin is characterized by the following equation:

r _r = R _r sin ( ? t + ? ), where ? t is the excitation frequency and? is the phase.

One representative example of propagation of thermal waves is shown in Fig. 46, arrow 4601 represents the direction of the fluid flow in the fluid path 4602 (and hence the propagation direction of the thermal wave) in the channel. The measurement contact portion is indicated by the contact portions 4611, 4612, and 4613. The fine heater is positioned close to the first contact portion 4611 and thermal waves are generated at the first contact portion and then propagated to the second and third contact portions 4612 and 4613 respectively located downstream from the first contact portion 4611 do. The distance between the second contact portion 4612 and the third contact portion 4613 is 4615.

Figure 46 illustrates an exemplary wave measurement 4620 at three further contacts 4611, 4612, and 4613. [ The heat wave generated at the first contact portion 4611 is indicated by the first curve 4621. [ Considering that the flow proceeds from left to right, this thermal wave will reach the contact 4612 at the second position just before the time that such wave reaches the contact 4613 at the third position. Outputs of the second and third contact portions 4612 and 4613 are indicated by curves 4622 and 4623, respectively.

The phase shift between the second 4622 and third 4623 signals can be measured by comparing the points of zero crossing for each. Dividing the distance 4615 between the second contact portion 4612 and the third contact portion 4613 by the time between each zero crossing (also referred to as propagation time) is equal to the flow rate of the fluid. In addition, multiplying the calculated flow rate by the diameter of the fluid path yields a volumetric flow rate.

The thermal wave may be monitored by using a temperature sensor, wherein, in one embodiment, such a temperature sensor comprises a thermistor, e.g., Cantherm, part number CWF4B153F3470, and is in physical contact with contacts located in the second and third positions have. In one embodiment, the contacts are measured / monitored using a thermal measurement device within the dialysis machine itself, which is in contact with the two metal contacts. This eliminates the need for separate temperature measuring devices to be integrated into the manifold. In a preferred embodiment, the dialysis machine, or non-disposable instrument, comprises a processor and a memory, comprising: a) a housing for communicating with a spring loaded contact which is in physical communication with the contact surface of the excitation probe upon installation of the disposable manifold, Frequency and b) the frequency of the temperature wave which is sensed by the receiving probe and communicated through the contact surface of the receiving probe to the spring loaded contacts or non-disposable instruments in the dialysis machine. The processor performs the derivation described herein to measure temperature levels and changes based on the stored data described above. It should further be appreciated that the temperature information is then passed on to the display driver which allows the information to be visibly displayed or acoustically communicated through the user interface.

In one embodiment, the detection circuit checks the phase shift by mixing the excitation signal and the received signal, comparing, and sending the result to a low pass filter to obtain phase shift information. More particularly, in one embodiment, phase detection is performed by multiplying the excitation frequency by the received signal. The result is a signal with one component of two components, that is, twice the frequency, and one component, which is a DC signal proportional to the phase shift between the excitation reference signal and the received signal. This is represented by the following equation:

Phase _{detection: e s r r = (E} s R r) / 2 [sin (2ωt + θ) + sin θ]

Here, e _s is an excitation signal, r _r is a reception signal,? T is an excitation frequency, and? Is a phase.

As described above, the present invention relies on wave measurements during propagation time and does not rely on thermal pulses. This method provides a significant advantage because it overcomes the uncertainty where the thermal pulse is suppressed to start the pulse edge and substantially increase the measurement noise. The waves are well dispersed, but even after dispersion, the phase shift of the sine wave remains more uniquely. Therefore, depending on the sine wave for the measurement, the noise is reduced.

Another advantage of the present invention lies in integrating thermal flow sensors in disposable manifolds. The plastics used in the manifolds act as adiabatic agents that have a beneficial effect on the measurement. As noted above, in one embodiment, a spring-loaded probe is used for the heat flow measurement device, which reduces cost and is disposable.

The design of the device of the present invention is based on three parameters: a) thermal excitation (frequency of the terminal input signal), b) expected flow rate (slower flow rate requires a different flow rate than the higher flow rate, Slow flow is more dispersed), and c) is optimized according to the amount and range of thermal dispersion. In one embodiment, the main parameters may be set to a constant setting, e.g., a constant phase shift, a constant frequency, or a constant flow field, in order to minimize noise and improve detection accuracy.

In one embodiment, a constant phase shifting method is implemented by using a phase sensitive detector and a digital control frequency generator. As described above, the propagation time causes a physical delay between the excitation probe and the receiving probe. At high flow rates the physical delay is small, while at low flow rates the physical delay is large. Thus, in order to maintain a constant phase shift, the excitation frequency is controlled through feedback from the phase sensitive detector. The excitation loop is included in the system, and excitation frequency can be dynamically adjusted so that important parameters, such as phase shift, are kept constant.

Referring to Figure 53, a schematic diagram of one embodiment of the present invention using a uniform phase shift mode of operation is shown. The liquid 5303 flowing through the channel 5301 passes through the excitation probe 5305 and the reception probe 5307 and such a probe is separated by a certain distance 5309 as described above. In one embodiment, the channel 5301 is part of a manifold that is inserted into the dialysis machine and is designed for use therein. The contact surface of the excitation probe 5305 is made to be in thermal contact with the heater driver 5325 and the contact surface of the receiving probe 5307 is made to be in thermal contact with the temperature sensor 5330 . Heater driver 5325 and temperature sensor 5330 are in electrical contact with circuitry integrated in and / or integrated within the dialysis machine.

On the excitation side, the circuit includes a reference signal source 5310 that transmits a signal having a phase [theta] r to an adder 5315 and also receives a signal input [theta] m from a low-pass filter, as described above. The two signals are summed, processed, or otherwise compared to produce an output that is sent to a voltage controlled oscillator 5320. The voltage controlled oscillator 5320 outputs a signal Rp with Rp = Kp sin (? T), which is received by the heater drive 5325 and used to drive the heater drive 5325, Lt; / RTI >

The thermal wave propagates through the channel 5301 as a function of the flow rate of the fluid 5303. The receiving probe 5307 thermally transmits the second heat wave to the temperature sensor 5330. [ The thermal second wave can be expressed as a function: Es = Ks sin (? T +? C).

As mentioned above, the temperature sensor 5330 is in electrical contact with circuits built into the dialysis machine or integrated into the dialysis machine. The second row of waves Es is sent to a coincidence phase sensitive detector using a multiplier 5335 and such components convert the second row wave Es to an input signal Rn, Here, Rn = Kn cos (? T)) to generate an output signal EsRn. The output signal EsRn (which can be expressed as EsRn = (KnKs / 2) [sin (2ωt + θc) + sin (θc)] is input into the amplifier 5340 and amplified by the constant K1. The amplified signal is then input into a low pass filter 5345, which receives an input signal from a voltage regulated oscillator 5320. The input signal from the voltage-controlled oscillator 5320 is used to change the filter threshold, or cut-off, of the low-pass filter 5345. The output from the low-pass filter 5345 (? M, which can be expressed as a function of KnKsK1? C / 2) is an indicator of the flow rate of the fluid that can be derived by any means known to those skilled in the art, And is transmitted again to the adder 5315 for use in generating the reference signal.

Figure 47 is a table illustrating the range of excitation frequencies dynamically adjusted to maintain a constant phase shift. Referring to Figure 47, the measurement process takes into account various parameters such as the flow rate 4701 varying between 25 and 600 ml / min and the flow rate 4702 between 17.36 mm / s and 416.67 mm / s . Using a value of 15 mm for the probe separation 4703, the excitation frequency 4705 will vary from about 1.16 Hz @ 25 ml / min to 27.78 Hz @ 600 ml / min. The corresponding values of the travel time and the received amplitude are detailed in columns 4704 and 4706, respectively. It should be noted that the receive amplitude is kept at zero for a constant phase shift.

Figure 48 illustrates the output of a phase sensitive detector plotted against a time axis 4810. The various curves 4820 represent a series of outputs of the phase sensitive detector for different values of the flow rate. The graph in FIG. 48 is plotted against the values given in the table of FIG. 47; Accordingly, the flow rate is 25 to 600 ml / min and the corresponding excitation frequency is varied from about 1.16 Hz to 27.78 Hz.

In another embodiment, the phase shift can be allowed to vary, but the frequency excitation remains constant. Constant frequency excitation is used with a phase sensitive detector, but no feedback mechanism is used. Figure 49 illustrates a table detailing the values of various parameters when excitation frequency 4906 is maintained at 1.157 Hz. These values are for flow rates varying between 25 and 600 ml / min (4901) and for flow rates ranging from 17.36 mm / s to 416.67 mm / s (4902). The probe separation 4903 is set to 15 mm while the corresponding value of the travel time 4904 is 0.0360 sec (value for the harmonic 4905 value of 1.000) to 0.864 sec. The change in phase shift is reflected in the corresponding received amplified value detailed in column 4907. Receive amplification 4907 is shown in the last column. Figures 50A and 50B illustrate the output of two sets of phase sensitive detectors (with respect to the range of flow rates specified in Figure 49) plotted against the time axis.

Referring to Figure 54, a schematic diagram of one embodiment of the present invention using a constant frequency operating mode is shown. The liquid 5403 flowing through the channel 5401 passes through the excitation probe 5405 and the reception probe 5407 and such a probe is separated by a certain distance 5409 as described above. In one embodiment, channel 5401 is part of a manifold that is inserted into the dialysis machine and is designed for use therein. The contact surface of the excitation probe 5405 is made to be in thermal contact with the heater driver 5425 and the contact surface of the receive probe 5407 is made to be in thermal contact with the temperature sensor 5430 . Heater driver 5425 and temperature sensor 5430 are in electrical contact with the integrated circuit and / or integrated into the dialysis machine.

On the probe side, the circuit includes a reference signal source 5410, such as a sine generator, that transmits a signal having a frequency (e.g., 1.17 Hz or about 1.17 Hz) to the heater driver 5425. The sign generator 5410 outputs a signal Rp where Rp = Kp sin (? T), which is received by the heater driver 5425 and used to power the heater driver 5425 to drive the blob 5405 To generate an excitation wave that is thermally transmitted to the excitation wave. The excitation frequency is preferably low enough so that the phase shift is less than 80 degrees at low flow rates. The sinusoid generator 5410 also outputs a signal Rn where Rn = Kn cos (? T) and such signal is generated by a multiplier 5435 and a low-pass filter 5445, .

The thermal wave propagates through the channel 5401 as a function of the fluid 5403. The receiving probe 5407 transmits the sensed heat wave to the temperature sensor 5430. The thermally sensed wave can be expressed as a function: Es = Ks sin (ωt + θc). The temperature sensor 5430 is in electrical contact with the integrated or integrated circuitry within the dialysis machine. The sensed heat wave Es is sent to a coincident phase sensitive detector using a multiplier 5435 which multiplies the sensed heat wave Es by the input signal Rn from the sine generator 5410, , Rn = Kn cos (? T)) to generate an output signal EsRn. The output signal EsRn (which can be expressed as EsRn = (KnKs / 2) [sin (2ωt + θc) + sin (θc)] is input into the amplifier 5440 and amplified by the constant K1. The amplified signal is then input into a low-pass filter 5445 that receives an input signal from a sine generator 5410. [ The input signal from the sine generator 5410 is used to vary the filter threshold, or cut-off, of the low-pass filter 5445. The output from the low-pass filter 5445 (? M, which can be expressed as a function of KnKsK1? C / 2) is a signal that is indicative of the flow rate of the fluid, which is derived by any means known to those skilled in the art. It should be noted that the frequency cutoff of the low-pass filter is approximately 1/20 of the excitation frequency. The low-pass filter will attenuate the 2ωt signal by about 80dB.

55 shows the relative phase shift of a signal generated in a constant frequency mode due to the low flow rate and the high flow rate. The excitation signal 5530 is generated at time zero. In the low flow scenario, the sensed signal 5520 is offset from the excitation signal 5530 by the phase shift of the θ _LF 5540, but in the high flow scenario, the sensed signal 5510 is the phase of the θ _hF (5550) Is offset from excitation signal 5530 by motion.

Regardless of whether a constant or varying phase shifting method is used for the measurement, using phase shifting as the basis of the flow measurement is advantageous over using amplitude because the amplitude is proportional to the external temperature Because it can be influenced by external factors such as effects.

In one embodiment, the non-invasive thermal fluid flow meter of the present invention provides a measurement range of 20 ml / min to 600 ml / min. In addition to the factors listed above, other factors that are important for designing a thermal flow meter for optimal performance include flow characteristics such as flow mode, maximum Reynolds number and flow rate; And physical characteristics of the flow cell, such as channel height, width, and length.

Figure 51 includes a table depicting an exemplary set of design parameters such that the flow pattern is maintained in layers and the Reynolds number 5109 is kept below 2000 for a maximum flow rate 5101 of 600 ml / min. The channel dimensions including the channel height 5102, the width 5103, the length 5104, the area 5105 and the hydrodynamic diameter 5106 are optimized to keep the flow style in layers. The Reynolds number 5109 is calculated after considering the values of the flow rate 5107, the hydrodynamic diameter 5106 and the properties of the water 5108, such as density, mechanical viscosity, and dynamic viscosity.

In one embodiment, the flow cell is designed for turbulent flow mode instead of layered. Such a design of the flow cell involves a constant flow area, which will also include a flow area that widens around the probe, which is reduced around the probe in the case of layered flow. As the area in the probe increases, the velocity of the fluid around the probe increases, and the increased velocity moves the flow pattern in a turbulent manner.

52 is a table illustrating another set of exemplary design parameters for an excitation and receive probe, scaled to have a thermal time constant 5205 of less than 1 millisecond for optimal performance, in one embodiment. to be. The factor considered for this purpose is the convection coefficient 5204, in this case the brass material, and its properties 5201, such as density, thermal conductivity and specific heat. Thus, the size of the probe 5202 and the exposed surface area 5203 are measured.

Temperature sensing

As mentioned above, the compact manifold for the dialysis system includes a temperature sensor. In one embodiment, the temperature sensor is located in the storage assembly. However, the temperature sensor can also be located outside the storage assembly, and in such embodiments, it can be integrated into the manifold.

There are three main ways to use temperature sensing that can be integrated into a manifold. One of ordinary skill in the art will recognize that variations in each method are possible without any significant change in the overall design of the manifold. Such a method is discussed below:

High Conductivity Fluid Contact

In a highly conductive direct fluid contact method, a metal disk is mounted into a wall of a manifold having a thermistor or any other suitable temperature sensor known to those skilled in the art, and such a thermistor or temperature sensor is mounted on the disk and the fluid on the patient side Contact position. Thus, the fluid temperature can be monitored through a metal disk.

Typically, the temperature is monitored by placing the thermistor in the fluid stream. The use of a metal disk for monitoring the temperature in the present invention offers the advantage of reducing the risk of contamination, and therefore the need to clean the thermistor is avoided.

Those skilled in the art will appreciate that any suitable metal, such as a metal disc of type 316 stainless steel, may be used for the purpose. In addition, any thermistor suitable for current application may be used. An exemplary thermistor is the part number 10K 3A1A manufactured by BetaTherm.

In one embodiment, the metal disk is single patient and disposable, and the thermistor is part of a dialysis machine and reused.

Intermediate conductive fluid contact

The pressure transducer membrane of the compact manifold is relatively thin and consists of an intermediate thermally conductive material. Typically a thickness of 0.040 "is used and may vary from 0.005" to 0.050 ". The thinner the material, the higher the thermal conductivity and the higher the thermal conductivity, the more accurately the pressure transducer membrane imposes the temperature of the dialysis fluid inside the dialysis machine The pressure transducer on the machine side and the fluid on the patient side are in direct contact with the pressure transducer by placing the appropriate temperature sensor inside the pressure transducer enables the fluid temperature to be monitored. Pressure transducer of the present invention includes a temperature sensor for calibrating the transducer due to temperature flow. Such a pressure transducer with temperature sensing characteristics may be used for this application purpose. Model MPT40. Using such a combination of sensors It is to avoid the direct contact of the measurement fluid to reduce the number of parts of the manifold. This provides an alternative to the metal disc, as used in the previous method.

Indirect optical temperature measurement

If the plastic wall of the manifold fluid path is of a limited thickness, for example, a wall of approximately 0.020 ", the plastic wall will be temperature balanced with the fluid inside the manifold. Under such conditions, non- An exemplary non-contacting optical temperature sensor is part number MLX90614, manufactured by Melexis. The non-contact method requires additional components to the manifold < RTI ID = 0.0 > The only requirement is a thinner portion in the fluid path wall. This method is costly and still maintains a single patient use stability characteristic.

One possible implementation for an integral conductivity sensor in a manifold is to perform as a conductive cell with an electrical pin in contact with the dialysis fluid. The technical details of an exemplary conductivity cell are shown in FIG. Referring to FIG. 57, the conductive cell 5700 includes a bias pin 5701 for applying a small and constant current to the fluid. The sensing pin 5702 detects the voltage in the fluid, where the magnitude of the detected voltage depends on the conductivity and temperature of the fluid. The temperature is measured using a thermistor 5703 located after the conductive cell 5700. [ Alternatively, the temperature can be measured by one of the means disclosed above. Knowing the measured temperature and voltage values at the sense pin 5702, the conductivity of the fluid can be measured.

The current applied through the bias pin 5701 may be a DC or AC signal, and is typically in the 50 to 100kHz frequency range. In one embodiment, the magnitude of the applied current is on the order of 10 mA. The sensing pin 5702 is located at a general depth during fabrication of the conductive cell, typically at a depth of +/- 0.001 inches with the cal solution in the cell. Thermistor 5703 has typical accuracy of 0.5 ° C. The conductive cells guide or form in situ conductive pins (biasing pins and sensing pins) into the manifold body so that they are brought into contact with the dialysis material, but not into the dialysate fluid passageway of the compact manifold Can be buried.

Disconnection detection

Embodiments of the disclosed dialysis system further include an apparatus and method for detection of disconnection in an extracorporeal blood circuit used in any blood processing path. Examples of blood process treatment routes include hemodialysis, hemofiltration, ultrafiltration, or apheresis. Vascular access for the establishment of an extracorporeal blood circuit is typically obtained by using a percutaneous needle or a luer connected catheter. The wire harnesses and methods use pressure pulses produced by the patient's beating heart as an indicator of intact needle or catheter for the vessel. The pressure pulse generated by the patient's heart is small; This is more so in the IV line of the extracorporeal blood circuit. To detect small pressure pulses, the present invention uses a cross-correlation method, wherein the reference cardiac signal is cross-correlated with the pressure pulse signal.

58 is a block diagram of a system 5800 for detecting disconnection of a patient from an extracorporeal blood circulation path, in accordance with an embodiment of the present invention. In accordance with an embodiment of the present invention, system 5800 includes an input arterial blood circuit 5802, a dialyzer 5804, a dialysis circuit 5806, a patient pulse pressure transducer 5808, a patient heart signal generator 5815 for reference, A single line monitor 5820, a controller 5825, and a conveying vein blood circulation path 5810. In various embodiments of the present invention, the blood that has been hemmed from the patient passes through the dialyzer 5804 via the arterial circulation path 5802, and the washed blood from the dialyzer 5804 flows via the venous blood circulation path 5810 And returned to the patient. The contaminated dialysate discharged from the dialyzer 5804 is refined or regenerated in the dialysate circulation path 5806, and is pumped back into the dialyzer 5804. In various embodiments of the present invention, the rinsed blood is returned to the patient ' s body via a percutaneous needle or a luer connected catheter. The blood flow in the return vein blood circulation path 5810 is typically in the range of 300 to 400 ml / min. It should be appreciated that any suitable dialysis circuit may be deployed.

The pressure transducer 5808 measures the blood pressure pulse of the patient performing the blood processing path and transmits the pulse pressure substantially continuously to the single line monitor 5820. In one embodiment, the transducer 5808 is an invasive or non-invasive venous pressure sensor located anywhere within the dialysis blood line (either the introductory arterial circulation path 5802 or the return venous return path 5810). In another embodiment, the transducer 5808 is an invasive or non-invasive venous pressure sensor located specifically in the dialysis blood line between the dialyzer 5804 and the patient, i.e., the return vein blood circulation path 5810. A non-invasive air bubble detector and / or a pinch valve (not shown) is optionally positioned between the Luer connection for the patient and the transducer 5808. In an embodiment of the present invention, the pressure transducer 5808 is positioned in close proximity to a needle or catheter inserted into the patient's body to provide access to blood vessels corresponding to the return vein blood circuit 5810. The pressure transducer 5808 is placed in close proximity to the needle or catheter to preserve waveform integrity. In other embodiments, the pressure transducer 5808 may be connected to any location within the return vein blood circuit 5810. [ In an embodiment of the present invention, the pressure signal generated by the pressure transducer 5808 is an alternating current (AC) signal, which is not an accurate vascular pressure measurement. Accordingly, the pressure transducer 5808 is not a high accuracy transducer.

The reference signal generator 5815 transmits the patient's heart signal substantially continuously to the single line monitor 5820 for reference. In an embodiment of the invention, the reference cardiac signal is obtained from a plethysmograph connected to the same body part (e.g. an arm) to which the needle or catheter is connected to supply the treated blood to the patient. In another embodiment of the present invention, the reference cardiac signal is obtained from a finger pulse sensor / oxygen concentration meter. In various other embodiments of the present invention, the reference cardiac signal may be an electrocardiogram (ECG) signal, a real-time blood pressure signal, a stethoscope, a venous pressure signal from a blood collection line, an oxygenation system pulse signal, an alternate site blood flow measurement signal, A blood flow measurement signal, an acoustic heart signal, a wrist pulse or any other cardiac signal source known to those skilled in the art.

The single line monitor 5820 detects disturbance in the conveying vein blood circulation path 5810 caused by disconnection of the needle or catheter from the body of the patient performing the blood processing process. To detect disconnection, monitor 5820 processes the patient pulse pressure transducer and cardiac reference signal. One skilled in the art should appreciate that such disconnection can be caused by any reason, such as a needle or catheter being drawn from the patient's body due to sudden movement of the patient. The single line monitor 5808 is described in detail with reference to FIG. Controller 5825 is any microprocessor known to those skilled in the art. The function of the controller 5825 is to receive the processed input from the monitor 5820, if desired, and to trigger appropriate operation accordingly.

Those skilled in the art should appreciate that the pressure transducer and reference signal are transmitted to the single line monitor 5820 through a transmitter integrated into the reference signal generator and pressure transducer. The transmitter can make wired or wireless communication with the corresponding receiver. Similarly, data from the single line monitor is transmitted to the controller 5825 via a wired or wireless connection. In one embodiment, such signaling may be accomplished using any suitable wired or wireless public and / or private network, such as a LAN, WAN, MAN, Bluetooth network, and / or the Internet. Also, in one embodiment, a single line monitor 5820 and a controller 5825 are located proximate to each other and located proximate the pressure transducer 5808 and heart reference signal generator 5815. [ In an alternate embodiment, both or both of the single line monitor 5820 and the controller 5825 are remotely located and / or remotely located from each other.

Fig. 59 is an example of a block diagram of an apparatus 5900 for detecting disconnection in a conveying vein blood circulation path according to an embodiment of the present invention. The single line monitor 5900 includes a pressure transducer receiver 5902, a reference signal receiver 5904, and a cross-correlation processor 5906. Transducer receiver 5902 and reference signal receiver 5904 receive input signals from respective pressure transducer 5808 and cardiac reference signal generator 5815 of Figure 58.

The pressure pulse signal obtained by the pressure transducer receiver 5902 and the reference heart signal obtained by the reference signal receiver 5904 are stored in the local memory and further supplied to the cross correlation processor 5906, Calculate the correlation of signal differences. The output of the processor 5906 is fed into the controller 5825 of Fig. If the output produced by the cross-correlation processor 5906 indicates a correlation between the two input signals, this indicates that the return vein blood circuit is intact. If the output produced by the cross-correlation processor 5906 does not indicate a correlation between the two input signals, then this is destroyed by the needles or catheters of the conveying vein blood circuit being pulled, and the controller 5825 of FIG. Indicating activation of an alarm, for example, an alarm for display and / or triggering the dialysis system completely or partially.

Those skilled in the art should appreciate that the present invention contemplates the use of any cross-correlation process to connect, counter, or otherwise generate measurable, quantifiable, and / or predictable correlations between pressure transducer signals and reference signals. In one embodiment of the invention, the cross-correlation is performed by using an amplifier, for example a lock in the SR810 Lock-In Amplifier manufactured by Stanford Research Systems of California, USA, and a very low signal-to- Various well-known techniques for cross-correlation detection and cardiac signals may be integrated in the cross-correlation processor 5906.

In various embodiments of the present invention, the cross-correlation function computed by the cross-correlation processor 5906 is used to measure the similarity between the two input signals, the reference cardiac signal and the pressure pulsation signal. The calculation of the cross-correlation function includes calculation of the sum of the calculated values of the points of the corresponding two input signal pairs within a specific time frame or range. The calculation also takes into account any potential phase difference between the two input signals by including a lead or lag term. The equation corresponding to the cross-correlation function is expressed as: < RTI ID = 0.0 >

Where N represents a number of samples, j represents a lag factor, and x1 and x2 represent two input signals, respectively.

FIG. 60 is a flowchart showing exemplary steps of a method for confirming disconnection of a patient from an extracorporeal blood circulation path according to an embodiment of the present invention. FIG. In operation, dialysis system software, including multiple instructions and execution on the processor, causes the patient to first attach to a cardiac signal generator (e.g., a finger pulse oximeter) to obtain a reference signal (6005). At this point, the patient may or may not be connected to the dialysis system. Dialysis system software, including multiple instructions and executions on the processor, after the cardiac reference signal has been acquired, or concurrently therewith, allows the patient to be connected to the system 5800 of Figure 58 so that the patient pulse pressure transducer signal (6010). The cross-correlation processor is then attempted to correlate the reference and transducer signals (6015). If the correlation is not achieved at the start, in one embodiment, the patient may cause all or a particular part to be turned off (6020), and in another embodiment, the controller 5825 of system 5800 of Figure 58 may automatically To reduce the noise level. For example, the interruption of the pump in the dialysis system can reduce noise and make it easier to capture and correlate the two signals. In another embodiment, the cross-correlation is attempted before the noise-generating system component, e.g., the pump, is turned on. Thus, locking down of correlation is attempted before complete system startup can be completed. In one embodiment, if correlation is not enforced, an alarm is triggered indicating that the patient dialysis system may be abnormal.

However, if a correlation is obtained, such correlation is substantially continuously monitored (6025). If there are any deviations from such a correlation, an alarm is triggered (6030) indicating the likelihood of leakage or, optionally, an attempt to re-establish the correlated signal and the system is either halted (fully or partially) and re-attempted. In one embodiment, if the nature of the correlation changes or goes beyond or within certain limits, certain system components, such as a pump, are interrupted and the cross-correlation processor attempts to re-establish the correlation. If the correlation can not be re-established, an alarm is triggered. In another embodiment, if the nature of the correlation changes or goes out of range beyond a predefined limit, then certain system components, such as an alarm before the pump is stopped and any additional attempts to re-establish the correlation, Is instantly triggered.

This method of monitoring disconnection provides an improvement distinct from the prior art. First, unlike the prior art, the present invention is responsive to whether the needle is pulled only slightly, or whether the needle is pulled and pulled at a very small distance from the insertion site. Second, the present invention does not require an excessive device, e.g., a moisture pad, located at the insertion site. Third, by correlating the patient's own cardiac signals, the false negatives are greatly reduced. Fourth, the combination of pressure pulse sensing and cross-correlation makes the present invention unique and enables detection of low signal-to-noise ratio signals. Fifth, continuously monitoring the cross-correlation state enables the system to detect small signal deviations that can potentially indicate a disconnection. Therefore, an apparatus and a method for detection of a disconnection in an extracorporeal blood circulation path used in any blood processing path are provided by the present invention.

Central venous pressure monitoring

Embodiments of the dialysis systems disclosed herein further include methods and systems for monitoring and controlling ultrafiltration (UF) flow rates to maintain the volume of fluid in a patient undergoing dialysis / ultrafiltration within a desired range . The present invention integrates central venous pressure (CVP) monitoring into a dialysis system and controls the flow rate of ultrafiltration (UF) using CVP measurements. The CVP feedback data serves as a safeguard to help prevent fluid headaches and provides a means of titrating the UF flow rate to improve therapy.

The CVP measurement involves measuring the mean pressure present in the central venous line used for dialysis and incorporating CVP measurements with dialysis. To measure CVP, a suitable catheter is inserted into the patient ' s body so that the tip of the catheter needs to be positioned within the thorax. 61 shows an exemplary orientation of a central venous catheter for blood filtration and CVP measurements. Referring to Figure 61, a Central Venous Catheter (CVC) 6110 is used to provide vascular access for UF. In this particular embodiment, the selected entry site 6120 for the CVC 6110 is below the collarbone 6130 in the subclavian vein 6140. One skilled in the art will appreciate that while maintaining the tip within the thorax, any other major vein in the patient's body may be selected as an alternative site for insertion of the CVC. CVC 6110 passes through subcutaneous tunnel 6150 and is secured with the aid of clamp 6160 and standard luer-lock 6170. The pressure at the tip of the CVC at the exit site 6180 is equal to the central venous pressure.

In one embodiment of the invention, the CVC 6110 is used to access blood during blood filtration and the central venous pressure can be measured by using a sensor that is internal to the blood filtration machine. In this case, no additional equipment is required for CVP measurements. In another embodiment, a dual lumen CVC is used for blood filtration. In this case, the proximal lumen can be used for blood collection, and the distal lumen (at the tip) can be used for the return of blood. A lumen or port can provide a CVP measurement. In both cases, when the CVC is used for blood access, the system of the present invention provides that the blood flow is temporarily interrupted prior to performing the CVP measurement to enable accurate pressure measurement. Thus, in one embodiment, the present invention integrates program control into a conventional dialysis machine to interrupt blood flow through the device based on a predetermined CVP measurement flow rate.

62 is a block diagram illustrating a dialysis control system of the present invention. 62, there is provided a user interface 6210 that receives input from a user (clinician) indicating a desired CVP measurement frequency and a desired CVP value range. These input values are provided to the central dialysis controller 6220. The central dialysis controller 6220 is a programmable system that can be used to regulate the flow rate of hemodialysis / ultrafiltration based on CVP monitoring and monitored CVP. Depending on the CVP measurement frequency determined by the user, the central dialysis controller 6220 sends a signal to the blood pump in the dialysis system 6230 to interrupt the blood flow whenever the CVP measurement is to be recorded. Thereafter, the CVP sensor in the dialysis system 6230 performs the measurements and sends it to the central dialysis controller 6220, which can send it to the user interface 6210 for display. After the CVP measurement is complete, the central dialysis controller 6220 sends another signal to the dialysis system 6230, causing the blood flow to resume. The central dialysis controller 6220 also keeps track of the measured CVP values and measures whether they are within a user-defined range. A decrease in CVP below the defined range will indicate hypovolemia. In such a case, the central dialysis controller 6220 interrupts the ultrafiltration process, so that additional fluid can not be removed until the CVP is restored to the desired range. In one embodiment, the central dialysis controller 6220 titrates ultrafiltrate removal to a range of 2-6 mm Hg to maintain the CVP within the desired range.

CVP monitoring and UF conditioning systems consider a wide range of CVP measurement systems integrated with conventional dialysis machines. Measuring CVP can be accomplished in many ways. In one embodiment, the CVP can be measured by a sensor located at the tip of a suitable catheter. In another embodiment, the CVP can be measured with a dedicated pressure transducer located remotely from the catheter, and such pressure transducer is fixed at the same level as the heart. Figure 63 is an illustrative example of the latter embodiment. 63, there is shown a catheter 6310 used to access blood. Catheter (6310) is located in Central Vena Cava (6320). The pressure transducer 6330 measures the central venous pressure at the cardiac level. The CVP measurement in this case is used to control the flow rate of blood filtration in the same manner as when the CVC is used.

In another embodiment, the CVP is measured by a remote sensor in a blood filtration machine. Referring to Figure 64, an exemplary blood circuit 6400 providing CVP measurements is illustrated. As the blood enters the circulation path 6400 from the patient, the anticoagulant is injected into the blood using the syringe 6401 to prevent clotting. A pressure sensor PBIP 6410 for measuring the central venous pressure is provided. The blood pump 6420 forces blood from the patient into the dialyzer 6430. Two different pressure sensors PBI 6411 and PBO 6412 are provided at the inlet and outlet of the dialyzer 6430, respectively. The pressure sensors PBI 6411 and PBO 6412 help to keep track of the fluid pressure at the dominating points in the hemodialysis system and to maintain the pressure. A pair of bypass valves B 6413 and A 6414 are also provided to the dialysis machine, which allows the fluid flow to be in the desired direction in the closed-loop dialysis circuit. The user can remove such air from port 6417 when air bubbles are detected by sensor 6418. [ The blood temperature sensor 6416 is provided before the air elimination port 6417. An AIL / PAD sensor 6418 and a pinch valve 6419 are used in the circulation to ensure a smooth, non-flammable flow of clean blood to the patient. A priming set 6421 is pre-attached to a hemodialysis system that assists the system to manufacture such a system before it is used for dialysis.

In order to perform the CVP measurement, the blood flow in the circulation path 6400 is stopped by stopping the blood pump 6420. At this point, the pressure at the catheter (not shown) used to access the blood will be balanced and the pressure measured at the pressure sensor PBIP 6410 in the blood filtration machine will be equal to the pressure at the catheter tip Will be the same. This measured pressure (CVP) is then used to control the flow rate of ultrafiltration and the flow rate of fluid removed from the patient.

Thus, in operation, the system of the present invention alters conventional dialysis systems to allow ultrafiltration to be performed at a predetermined flow rate by the physician. Periodically, blood flow is discontinued and mean CVP is measured using one of the various measurement methods described above. In one embodiment, a safe mode is provided, and in such a safe mode, if the CVP falls below a preset limit, blood filtration is stopped and an alarm is sounded.

In another application, patients with high blood volume, such as those suffering from Congestive Heart Failure (CHF), may be given ultrafiltration to remove body fluids. It is well known in the art that the ultrafiltration process removes body fluids from the blood and that the body fluids to be removed are located in the interstitial space. In addition, the flow rate of fluid flow from the epileptic space into the blood is not known. Without the system of the present invention, the physician can only guess the fluid withdrawal from the blood stream and the epileptic fluid removal flow that will balance it with the body fluid back flow into the blood from the epileptic space, and set the dialysis machine for such flow. In such a scenario, constant monitoring at the physician's side requires that the body fluid removal flow should not over-hydrate or under-hydrate the patient. According to the system of the present invention, the physician can prescribe the total amount of fluid he desires to remove, typically the amount calculated from the patient's body weight, and the minimum acceptable mean CVP. Such a system then removes the maximum flow rate of fluid that automatically maintains the desired CVP. That is, the system of the present invention automatically balances the fluid removal rate and the fluid flow rate from the epileptic space into the blood.

It should be noted that the normal CVP level is 2 to 6 mm Hg. Elevated CVP is an index of hyperinflation and decreased CVP is indicative of hypovolemia. Using the present invention, the patient begins ultrafiltration time with a CVP above normal, e. G., 7 to 8 mm Hg, for example, such time from a final CVP target of 3 mmHg through a treatment time of 6 hours I can finish it. However, if the removed fluid reaches only 50% of the final removal target, while the CVP does not exceed 50% of the desired drop in the middle of such processing time, the system may reduce the fluid removal target or reduce the fluid removal rate Lt; / RTI > Other measures can be taken based on more complex algorithms. The net result is to avoid hypovolemia by monitoring the actual value and flow rate of the CVP. It should be appreciated that this method may also be useful in controlling fluid removal rates for all types of renal replacement therapies, as well as during hemofiltration.

Monitor and maintain capacity accuracy

Embodiments of the dialysis systems disclosed herein include methods and systems for maintaining the correctness of the replenishment fluid and the output fluid in the hemodialysis system. In one embodiment, the method includes swapping the pumps used at the makeup fluid side and at the output side to cause the same amount of fluid to be pumped on each side. The pump-swapping system of the present invention provides an accurate means for maintaining fluid volume during the dialysis process and can be implemented at low cost for reuse devices as well as disposable devices.

Figure 65 illustrates an exemplary pump swapping circuit as used in one embodiment. The pump swap circulation path 6500 for blood filtration includes two pumps, pump A 6545 and pump B 6555. These two pumps are in fluid communication with the supplemental fluid circuit R 6560 and the output fluid circuit O 6570. The fluid communication relationship is enabled by two pairs of two-way valves 6505 and 6507. In the case of the supplemental fluid circuit R 6560, the supplemental fluid supply source 6510 supplies fluid to the pair of the two-way valve 6505 through the restrictor 6517. Thus, depending on which of the two valves in the pair 6505 is open, the supplemental fluid is supplied to the second set of two-way valve 6507 by either pump A 6545 or pump B 6555 Lt; / RTI > This set of two-way valve 6507 channels the makeup fluid to alternative circuit R 6560, which is in fluid communication with the output 6542 of the dialyzer 6540. In this embodiment, the communication relationship with the output 6542 of the dialyzer 6540 is in the form of an injection after dialysis. In another form known in the art, the communication relationship is communication with the input section 6544 of the dialyzer. One of ordinary skill in the art will recognize that any form of the two forms may be used without affecting the scope of the present invention.

Way valve 6505 is configured to be alternately opened such that any of the following fluid communication paths can be established:

Between output fluid circuit O (6570) and pump A (6545);

Between the supplementary fluid circuit R (6560) and the pump B (6555);

Between the supplementary fluid circuit R (6560) and the pump A (6545); And

· Between output fluid circulation path O (6570) and pump B (6555).

The system 6500 also includes two pressure sensors 6515 and 6516. Sensor 6516 is located on output circuit O 6570 and sensor 6515 is located proximate to supplemental fluid supply source 6510. [ Pressure sensors 6515 and 6516 are used to monitor pressure. Pressure data from these sensors is supplied to the active limiter 6517 via the differential amplifier 6525. [ Depending on the pressure measurements, restrictor 6517 variably limits the flow of the makeup fluid as required.

During dialysis, additional fluid can be removed from the patient, if necessary, in the form of ultrafiltrate (UF). To this end, a UF pump 6535 is provided to pump the UF to the bag or drain 6530. Because the UF fluid is removed before the pressure measurement point at O (6570) as the output fluid sub-circulation, the volumetric accuracy is maintained regardless of how much or how little the UF is removed.

Operationally, the volumetric accuracy in the hemodialysis system of the present invention is achieved by swapping the pumps 6545 and 6555 used on the supplementary fluid side and the output side such that the same amount of fluid is pumped at each point after an even number of swaps . Two pairs of two-way valves 6505 and 6507 enable the alternate use of the pump with the supplemental fluid circuit R 6560 and the output fluid circuit O 6570, respectively.

In one embodiment, the pump used is a peristaltic pump. Those skilled in the art will recognize that other types of pumps may also be used because the volume balance in the kidney dialysis is achieved by the use of pump-swapping technology and is not dependent on the type of pump. In one embodiment, pump A 6545 delivers more fluid per unit time than pump B 6555. Thus, this will lead to the supplemental fluid being pumped more than the output fluid at any given time.

Those skilled in the art will appreciate that a pump comprising disposable components can have a differential pumping rate because the disposable components are of the same size and type, but the volume across the disposable component is not the same. For example, the volumes of two disposable syringes of nominally equal size inserted into two syringe-pump assemblies will not be exactly the same. Those skilled in the art will also recognize that two pumps without disposable components can generally be adjusted to have no differential in pumping rate. Examples of pumps employing disposable components that may be practiced in accordance with the present invention include, but are not limited to, rotary or linear peristaltic pumps, syringe pumps, rotary vane pumps, centrifugal pumps, and diaphragm pumps.

In order to achieve a volume balance between the makeup fluid and the output fluid, pumps 6545 and 6555 are swapped every T minutes. Due to the specific nature of the pump at the end of the first T min interval, pump A 6545 will deliver more volume than pump B 6555. The fluid volume delivered by pump A 6545 is referred to as "Q ". Thus, during the first pumping interval "T ", when the supplemental fluid is sent through pump A 6545 and the output fluid is sent through pump B 6555, at the end of time interval T, More replenishment fluid "Q" than the output fluid will be pumped in replenishment fluid circuit R 6560.

Thereafter, pump A 6545 and pump B 6555 are swapped in the next time interval, and the output fluid at circulation O 6570 is pumped by pump A 6545 and the supplemental fluid at circulation path R 6560 Is pumped by pump B (6555). At this time interval, the replenishment fluid "Q" at R (6560) will be pumped less than the output fluid at O (6570). Thus, at the end of the second interval (and the end of the even swapping), the difference in the pumped volume during each interval will be Q-Q = 0. Thus, the net volume difference is zero after an even number of swaps, achieving a capacitive balance between the injected solid fluid through the dialyzer and the output fluid flowing back therefrom. One of ordinary skill in the art will recognize that there can be minute changes in flow rate through the pump over time and thus minute changes in delivered volume per unit time. In such cases, the net volume difference may not be exactly zero, but it may be very close to zero.

The volume pumped by the peristaltic pump is dependent on the head pressure. The head pressure for the pump is a function of the sub-circulation path, not the pump, and is systematically different in the supplemental fluid circuit R 6560 relative to the output circulation path O 6570. Accordingly, it is necessary to make the head pressures experienced by the pump A 6545 and the pump B 6555 equal.

In one embodiment, the head pressures are the same by adjusting the restrictor 6517 on the input circuit from the supplemental fluid source 6510. [ Limiter adjustment is accomplished based on the output of the differential amplifier 6525 which results in a pressure difference between the pressure values measured by the output pressure sensors 6515 and 6516 located between the pump 6545 and the pump 6555 . The magnitude of the desired compensation will depend on how much the pump is affected by the head pressure at the supplemental fluid circuit R 6560 and the output fluid circuit O 6570. The head pressure at circulation path O (6570) will typically be negative pressure. The head pressure at circulation R 6560 will be positive if the supplemental fluid bag (source) 6510 is raised above the level of the pump and will be negative pressure if the bag is vertically below the level of the pump will be. In the case of pumps using heavy duty pump tube segments, this difference may be relatively small.

As mentioned, the head pressure measures the pressure at sub-circulation R (6560) and O (6570) and provides these pressures as input to the differential amplifier 6525 and the influx from the supplemental fluid bag 6510 to the differential By tuning to a variable limiter 6517 at sub-circuit R 6560, which is adjusted by the output of amplifier 6525. [ Accordingly, it is necessary to adjust the average difference between the head pressures of the two sub-circulation lines in an unadjusted state, since the head pressure is a function of the sub-circulation path rather than the pump. The unadjusted pressure can be measured initially and at a desired interval during the operation by pausing the adjustment. Such recalibration does not require stopping the pumping.

In one embodiment, the pump head pressure may vary from zero to a few hundred mmHg or more, depending on the dialyzer being introduced, the height of the replenishment fluid for the dialyzer, and the dialysis fluid flow rate setting. For example, in the case of a 200 mL / min dialyzate flow and a fill fluid bag hanging 5 to 10 inches higher than the dialysis device, the pressure difference is in the 10 mmHg range. Generally, when the pressure at the supplemental circulation path R (6560) is higher than the pressure at circulation O (6570), the flow restrictor 6517 will limit the flow from the supplemental fluid source 6510 to compensate for the pressure differential.

For a dialysis system using a closed-loop dialysate circulation path where the dialysate fluid passes through the adsorbent cartridge and is constantly recirculated, Figure 66 shows an alternative pump swapping circuit. The pump replacement circulation path 6600 for hemofiltration includes two pumps, pump A (6645) and pump B (6655). These two pumps are in fluid communication with the recovery fluid circulation path R (6660) and the adsorbent fluid circulation path S (6670). Fluid communication is facilitated by two pairs of bi-directional valves 6605 and 6607. For the recovery fluid circuit R 6660, a reservoir fluid supply source 6610 provides fluid to the pair of bi-directional valves 6605 through the restrictor 6617. Thereafter, as the two valves of this pair 6605 are opened, the supplemental fluid is pumped to the second set of bidirectional valves 6607 by either pump A 6645 or pump B 6655. This set of bi-directional valve 6607 directs fluid to the return path R (6660) in fluid communication with the inlet port 6642 of the dialyzer 6640, via the adsorbent cartridge 6608 and through the reservoir 6610 send.

This pair of bidirectional valves 6605 may be configured to open alternately so that any of the following fluid communication paths may be established:

Between adsorbent fluid circulation path S (6670) and pump A (6645);

Between recovery fluid circuit R (6660) and pump B (6655);

Between withdrawal fluid circuit R (6660) and pump A (6645); And

● Between adsorbent fluid circulation path S (6670) and pump B (6655).

System 6600 also includes two pressure sensors 6615 and 6616. The sensor 6616 is located on the adsorbent circulation path S 6670 and the sensor 6615 is located close to the reservoir fluid source 6610. Pressure sensors 6615 and 6616 are used to monitor the pressure. The pressure data from this sensor is provided to the active limiter 6617 via a differential amplifier 6625. Depending on the pressure measurement, restrictor 6617 variably limits the flow of reservoir fluid if desired.

As in the previous embodiment, this embodiment provides a UF pump 6635 so that additional fluids in the form of UF (ultrafiltrate) can be removed from the patient during dialysis, if desired. The UF pump 6635 pumps the ultrafiltrate to the bag or drain 6630. Since the UF fluid is removed before the pressure measurement point at the adsorbent fluid sub-circulation path S (6670), volumetric accuracy is maintained regardless of how much or how little the UF is removed.

In use, the volumetric accuracy in the hemodialysis system of the present invention is such that pumps 6645 and 6655 are used on the adsorbent side and on the recovered fluid side so that an equal amount of fluid is pumped at each point after an even number of swaps Swapping. The two pairs of bidirectional valves 6605 and 6607 facilitate the use of each pump alternately according to the recovered fluid circuit R 6660 and the adsorbent fluid circuit S 6670.

In one embodiment, the pump used is a peristaltic pump. Those skilled in the art will recognize that other types of pumps may also be used, as the volumetric balance in kidney dialysis is achieved by using pump-swapping techniques and is not dependent on pump type. In one embodiment, pump A 6645 delivers more fluid per unit time than pump B 6655. As such, it will be possible to pump more recovered fluid relative to the adsorbent fluid at any given time.

Those skilled in the art will recognize that even though the disposable components have the same size and type, the pump comprising the disposable component may have pumping speed differences, since the volume across the disposable component is not the same. Those skilled in the art will also appreciate that two pumps without disposable components can usually be adjusted such that the pumping speed between these two pumps does not differ.

In order to achieve a volume balance between the recovered fluid and the adsorbent fluid, pumps 6645 and 6655 are swapped every T minutes. At the end of the first 'T' interval, due to the particular characteristics of the pump, pump A 6645 will deliver more volume than pump B 6655. The volume of fluid delivered by pump A 6645 is referred to as 'Q'. Thus, during the first pumping interval 'T', when the reservoir fluid is sent through pump A 6645 and the adsorbent fluid is sent through pump B 6655, at the end of time interval T, the circulation path S (6670 Quot; Q " reservoir fluid will be pumped in the withdrawal fluid circuit R (6660) as compared to the adsorbent fluid at < RTI ID = 0.0 > Thereafter, pumps A 6645 and B 6655 are swapped in the next time interval, and the adsorbent fluid in circulation path S 6670 is pumped by pump A 6645 and the withdrawal fluid at circulation path R (6660) Is pumped by pump B (6655). At this interval, the reservoir fluid at R (6660) of less 'Q' will be pumped compared to the adsorbent fluid at S (6670). Thus, at the end of the second interval (and at the end of the even-numbered swaps), the difference in volume pumped during each interval will be Q-Q = 0. Thus, the total volume difference is zero after an even number of swaps, thereby achieving a volume balance between the injected recovered fluid and the adsorbent fluid returning from the patient through the dialyzer. In addition, the total volume difference may sometimes be close to zero, not exactly zero, since there may be some, usually small, changes in flow rate through the pump over time, such that the volume delivered per unit of time changes.

As such with respect to the embodiment shown in FIG. 65, the volume pumped by the peristaltic pump in the embodiment illustrated in FIG. 66 is dependent on the head pressure. Also, since the head pressure for the pump is a function of the sub-circulation path, not the pump, and there is a systematic difference in the recovery fluid circulation path R (6660) relative to the adsorbent circulation path S (6670) It is necessary to equalize the head pressures indicated by the head 6655.

In one embodiment, the head pressure is the same by adjusting the restrictor 6617 on the input circulation path from the reservoir fluid source 6610. [ The limiter adjustment is accomplished in a similar manner to the embodiment of FIG. 65 and is based on the output of differential amplifier 6625. Differential amplifier 6625 calculates the pressure difference between the pressure values measured by output pressure sensors 6615 and 6616 located between pump 6645 and pump 6655. [ The magnitude of the desired compensation will depend on how the pump is affected by the head pressure at the recovery fluid circuit R (6660) and adsorbent fluid circuit S (6670). The head pressure at the circulation path S (6670) will typically be negative. The head pressure at circulation R (6660) will be positive if the reservoir 6610 is raised above the pump level and negative pressure if the reservoir 6610 is vertically below the pump level. In the case of a pump using a large pump tube segment, this difference would be relatively small.

As mentioned, the head pressure is used to measure the pressure in sub-circulation R 6660 and S 6670 and to provide this pressure as an input to differential amplifier 6625 and to provide a sub- - by adjusting the inflow from the reservoir 6610 to the variable limiter 6617 in the circulation path R (6660). Accordingly, it is necessary to adjust the average difference between the head pressures of the two sub-circulation lines in the unadjusted state, since the head pressure is a function of the sub-circulation path rather than the pump. The pressure in the unregulated state can be measured initially and at desired intervals during operation by simply stopping the adjustment. Such recalibration does not require stopping the pumping.

In one embodiment, the pump head pressure may vary from 0 to several hundreds of mmHg or more, depending on the dialyzer being introduced, the height of the reservoir for the dialysis device, and the dialysis fluid flow rate setting. For example, the pressure differential is in the range of 10 mmHg, with a dialysate flow of 200 ml / min and a reservoir located 5 to 10 inches above the pump of the dialysis machine. When the pressure in circulation R (withdrawal) 6660 is higher than the pressure in circulation S (6670) (from the dialyzer), flow restrictor 6617 limits the flow from reservoir 6610 to compensate.

In either the configuration of FIG. 65 or the configuration of FIG. 66, there may sometimes be an increased efflux to the dialysate circulation segment (O 6570 or S 6670, respectively) due to the increase of the dialyzer membrane throughput pressure (TMP). This can occur, for example, due to outflow obstruction of the dialyzer (6540 or 6640, respectively). In this case, there may be a possibility that the restrictors (6517 or 6617, respectively) may not be open enough to adjust, for example when the supplemental fluid source 6510 or reservoir 6610 is located below the level of the pump . To accommodate this, a booster pump may be inserted into the circulation path after the supplemental fluid source 6510 or reservoir 6610. The booster pump may be configured to automatically adjust in the case of differential amplifiers (6525 or 6625, respectively) and / or limiters (6517 or 6617, respectively) may not be able to calibrate the system.

Since time gaps are formed during a pump swap, it is necessary to calculate the time interval between swaps. This calculation is a function of the maximum allowable difference in the amount of fluid pumped, as determined by the two functions at any given time. However, these calculations must compensate for the difference in head pressure between the fluid coming out of the fluid container and the pump for fluid returning from the patient through the dialyzer.

The number of times the pump is swapped depends on the maximum allowable increase or decrease of the fluid volume in the patient during the dialysis process for any given interval T. [ For example, if the total allowable gain or loss is 200 ml and the replenishing fluid is input at a rate of 200 ml / min, the number of pump swaps for the various levels of the difference in pumping speeds of the two pumps is shown in Table 67 6700 < / RTI >

The following description refers to the parts in the embodiment shown in Fig. 65, but is also applicable in the same manner as the embodiment illustrated in Fig. 67, the first column 6701 of the table indicates that the percentage difference in pumping speed of the two pumps, pump A 6545 and pump B 6555, is less than (200 ml of allowable total gain or loss Swapping of the pump at time intervals of 200 ml / 2 ml = 100 minutes will achieve a 0 volume difference, when 1% to 2 ml fluid volume difference, for example. Similarly, in the case of a pumping speed difference of 2%, swapping of the pump at an interval of 200 ml / 4 ml = 50 minutes will achieve volume balance and the like. This is illustrated in the next column of Table 6700.

Even if a much greater stringent restriction provides a maximum volume of fluid that can be injected into or removed from the patient, for example, +/- 30 ml in contrast to ± 200 ml in the example, the pumping difference is 5% The swap interval for 30 ml / 10 ml = 3 minutes. Since the switching of the bidirectional valve (shown as 6505 in FIG. 65) is necessary to swap the pump and the start and stop of the pump is not required, even a short interval of three minutes (or less) It is possible.

More frequent pump swapping can also alleviate any deviations in pump tube performance. In the system of the present invention, since the tubes of both pumps are treated with the same number of impacts, the performance of the pump tends not to deviate.

When using the pump-swapping method, differential errors in the volume balance of the makeup fluid and the output fluid can be caused if this process does not stop at an even number of swaps. Thus, in one embodiment, the system is configured to stop only when an even swap is completed, unless the system is interrupted. Possible effects of the problem ending with a total differential error can also be reduced by swapping the pump more often. In any case, it can be ensured that any overall difference will not deviate from the originally set bound for the maximum allowable total fluid loss or gain, e.g., ± 200 ml. Thus, in one embodiment, the present invention includes a controller in data communication relationship with all operating pumps. The controller includes software with counters that track the number of pump swaps by increasing. When the number of pump swaps is odd, the controller executes a blocking signal that prevents the system from being stopped. The controller will issue a blocking signal when the counter is even, thereby allowing the system to halt. The controller is an additional source for delivering a swapping signal which causes the appropriate valve to open and close causing pump swap.

During the process of pump swapping, there will be a small amount of residual fluid moving from one sub-circulation path to another sub-circulation path. For example, if the peristaltic pump tubing is 0.8 ml / inch and the pump-tube segment length is 3 inches, the residual amount will be 2.4 ml (3 inches x 0.8 ml / in = 2.4 ml) per period. Typically for a period of 50 minutes, and at a pumping rate of 200 ml / min, 10 liters of fluid (50 min x 200 ml / min = 10,000 ml) will be pumped. Thus, the percentage of residue to total fluid pumped per liter is only 0.024% (2.4 ml / 10,000 ml = 0.024%). Even the effect of this low percentage of residue is rendered ineffective, as there is movement between sub-circulations due to pump swapping to offset the overall effect.

With respect to the problem of residual fluid entering one sub-circulation to another sub-circulation path, the fluid exiting the dialyzer is merely from the patient and is thus completely safe to re-enter the patient with the sterile filling fluid.

As noted above, during dialysis, additional fluid can be removed from the patient in the form of ultrafiltrate (UF) if desired, and the UF pump is provided for this purpose in the system of the present invention. Also, volume accuracy is maintained regardless of how much or how little UF is removed.

When pumping an ultrafiltrate to remove excess fluid from a patient, the system has a lower pump speed, e.g., 10 ml / min, which is contrary to a high rate, such as 200 ml / min, Achieving full volume accuracy is even easier. For example, if the desired accuracy is ± 30 ml, over a period of 60 minutes, 600 ml will be pumped at a pump rate of 10 ml / min. This suggests that 30 ml / 600 ml = 0.05 or 5% is adequate to achieve the percentage of accuracy achieved. However, those skilled in the art will recognize that the system of the present invention can achieve the desired volumetric accuracy regardless of the pump speed of the UF pump in the dialysis machine.

Disposable Conductivity Sensor

86 shows a disposable conductivity sensor 8690 that includes, among other components, a tubular section having a first end for receiving a first disposable tubing segment and a second end for receiving a second disposable tubing segment will be. The tubular section includes a first plurality of probes extending in an internal volume defined by the tubular sections and constituting a fluid flow path. In one embodiment, at least three separate long probes are used. In another embodiment, at least four separate long probes are used.

Disposable conductivity sensor 8690 is configured to be attached to a second plurality of probes that are complementarily joined together to be fixedly and / or permanently attached to the outer side of the control unit. Preferably, the attachment site comprises a portion of the outer surface of the control unit on the same side as the dialyzer or on the same side as the dialyzer, as described above in connection with Fig. In use, the disposable conductivity sensor 8690 is snapped to a non-disposable plurality of probes that complement each other in a transient but attached relationship. Thus, the second plurality of probes are accommodated in the first plurality of probes and positioned in communication therewith. Thereafter, the probe, as discussed hereinabove, sends and detects a signal in a fluid flow path defined by the first disposable tubing segment, the tubular section of the conductivity sensor, and the second disposable tubing segment, Signal by sending it to the memory and processor in the control unit for use in monitoring and controlling the dialysis system.

Valve system

In order to be able to regulate the flow through the blood and dialysate circulation path and to select the desired mode of operation (hemodialysis or hemofiltration), in one embodiment, a system is provided with an exotropic valve (s) as described above . Such a valve may be operated by the user to direct the dialysis fluid flow through the dialyzer in one mode of operation or directly to the patient in the dialysis fluid flow of the infusion fluid level in the second mode of operation. This bi-directional valve can also be integrated with the compact manifold of the dialysis circuit. This is illustrated in FIG. In Figures 68 to 70, it should be noted that for clarity, the corresponding components have the same number.

68, extracorporeal blood treatment system 6800 includes a plurality of molded blood and dialysate fluid paths as well as a plastic molded compact manifold 6810 that encapsulates a plurality of sensor zones, valves, and fluid pump segments do. The dialyzer 6805 completes the blood circulation path of the system 6800 when it is connected to the arterial blood tube 6801 and the venous blood tube 6802 of the manifold 6810. In one embodiment, the dialyzer 6805 is disposable. Two lines 6803 and 6804 are used to circulate spent dialysate and fresh dialysate, respectively. A bidirectional valve 6845 and a backup bidirectional valve 6846 are provided to operate the system 6800 in either of two modes (hemodialysis and blood filtration).

The backup valve 6846 is used because the dialysis fluid used in hemodialysis is not sterilized and the fluid used in hemofiltration is not of injection grade. In the case of operation in the hemodialysis mode or in the presence of a leak or other failure of the valve 6845, the valve 6846 provides double protection against fluid pumped into the patient blood stream. The inclusion of the backup valve 6846 makes it safe to use one manifold for both hemodialysis and blood filtration. As noted above, the bi-directional valve, for example backup valve 6846, consists of two single valves. In this case, both of the one-way valves are in series, thereby providing dual protection by closing both ports of the bi-directional valve 6846 to prevent the dialysis fluid from entering the blood stream. In other embodiments, an intended manifold may be manufactured solely for hemodialysis, which may result in the safe removal of valve 6846 due to the absence of a connection between the dialysis fluid circuit and the blood circuit.

Figure 69a illustrates a circuit for a hemodialysis / blood filtration system in accordance with one embodiment of the present invention in greater detail. The spent dialysis tubing 6903 and the new dialysis tubing 6904 are each connected to a dialysis regeneration system 6906 thereby completing the dialysis tubing circulation path of the system 6900. The dialysis water recovery system 6906 further includes a disposable absorbent cartridge 6915 and a reservoir 6934 for maintaining the dialys cleaned by the cartridge 6915. 69A is an enlarged view of an extracorporeal blood treatment system 6900 configured to operate in a hemodialysis mode, as described with reference to Fig. 69B. The corresponding components in Figures 69A, 69B and 69C have the same number.

The blood circulation path 6920 includes an interlocking blood pump 6921 that draws the blood mixed with the impurities of the patient artery along the tube 6901 and pumps the blood through the dialyzer 6905. Syringe device 6907 is injected into a blood stream containing an anticoagulant, e. G., Heparin impurities. Pressure sensor 6908 is disposed at the inlet of blood pump 6921 and pressure sensors 6909 and 6911 are disposed upstream and downstream of the dialyzer 6905 to monitor pressure at these advantageous points.

As the purified blood flows downstream from the dialyzer 6905 and flows back to the patient, a blood temperature sensor 6912 is provided in the line to maintain a track of the temperature of the purified blood. Air remover 6913 is also provided to remove accumulated gas bubbles in clean blood from the dialyzer. A pair of air (bubble) sensors (or optionally a single sensor) 6914 and a pinch valve 6916 are used in the circulation path to prevent the accumulated gas from returning to the patient.

The dialysis water circulation path 6925 includes two dual-channel pulsatile dialysis pumps 6926 and 6927. The dialysis water pumps 6926 and 6927 respectively draw the spent dialysate solution from the dialyzer 6905 and withdraw the regenerated dialysate solution from the reservoir 6934. At the point where the dialysate fluid used from the dialyzer 6905 enters the dialysate circulation path 6925, a blood leak sensor 6928 is provided to detect and prevent any leakage of blood to the dialysate circulation path. Thereafter, the spent dialysate from the outlet of the dialyzer 6905 travels through the bypass valve 6929 to reach the bidirectional valve 6930. A pressure sensor 6931 is disposed between the valve 6929 and the valve 6930. An ultrafiltrate pump 6932 is provided in the dialysis water circulation loop which is periodically operated to extract the ultrafiltrate waste from the spent dialysate and store it in the ultrafiltrate 6933 which is emptied periodically.

As described above, spent dialysate is regenerated using adsorbent cartridges. The dialysis product regenerated by the adsorbent cartridge 6915 is collected in the reservoir 6934. The reservoir 6934 includes a conductivity sensor 6961 and an ammonia sensor 6962, respectively. From the reservoir 6934, the regenerated dialysis material proceeds through flow restrictor 6935 and pressure sensor 6936 to reach the bi-directional valve 6937. Depending on patient requirements, a desired amount of infusion solution from reservoir 6950 and / or a concentrated solution from reservoir 6951 may be added to the dialysis fluid. Injections and concentrates are sterile solutions containing minerals and / or glucose that help maintain minerals such as potassium and calcium to a level prescribed by a medical practitioner in a dialysis fluid. Bypass valve 6941 and peristaltic pump 6942 are provided to select the desired amount of infusion and / or concentration solution and ensure proper flow of solution to the washed dialysate exiting reservoir 6934.

The dialysis water circulation path includes two bidirectional valves 6930 and 6937. Valve 6930 directs one stream of spent dialysate to the first channel of dialysis water pump 6926 and another stream of spent dialysate to first channel of dialysis water pump 6927. Similarly, valve 6937 directs one stream of regenerated dialysate to the second channel of dialysis water pump 6926 and another stream of regenerated dialysate to second channel of dialysis water pump 6927.

A stream of spent dialysate from pumps 6926 and 6927 is collected by a bi-directional valve 6938 and a stream of regenerated dialysate from pumps 6926 and 6927 is collected by a bi-directional valve 6939. Valve 6938 combines the two streams of spent dialysate into a single stream that is pumped via pressure sensor 6940 and through adsorbent cartridge 6915 where the spent dialysis The water is cleaned and filtered, after which it is collected in reservoir 6934. The valve 6939 combines the two streams of regenerated dialysate into a single stream which flows through the bypass valve 6947 to the bidirectional valve 6945. A pressure sensor 6943 and a dialysis water temperature sensor 6944 are provided on the dialysate flow stream to the bidirectional valve 6945.

By switching the state of the bidirectional valves 6930, 6937, 6938, and 6939, the two pumps 6926 and 6927 allow one to withdraw the dialysis fluid from the dialyzer 6905 and the other to withdraw fluid from the dialyzer 6905 . Such a transition, when performed periodically over a shorter period of time compared to the dialysis period, over the longer period of the entire dialysis period, the dialysate fluid volume pumped into the dialyser is equal to the amount of fluid that is pumped out, ) Is removed by the ultrafiltrate pump 6932 as discussed above.

In the hemodialysis mode, the bi-directional valve 6945 may allow the regenerated dialysate to enter the dialyzer 6905 to enable normal hemodialysis of the patient's blood. One side of the valve 6945 is closed and leads to the patient's blood collection line. The other bi-directional valve 6946 acts as a backup to maintain the dialysate from the patient's blood line where both ports of the valve 6946 are closed, even if the valve 6945 leaks or fails.

69C, in the hemofiltration mode, the bi-directional valve 6945 is connected to the reservoir 6946 via a valve 6946, both ports open, to directly enter the stream of purified blood exiting the dialyzer and to flow back to the patient. The dialysate can be operated to derive a stream of fresh ultrapure water from dialysate 6952.

It should be appreciated by those skilled in the art that the backup anisotropic valve 6946 is a redundant safety valve that prevents the failure of one valve 6945 in the hemodialysis mode from directly injecting regenerated dialysate into the patient do. That is, both valves 6945 and 6946 may be operated by the system to cause the fluid to be directed to the patient's venous line as a safety consideration. In one embodiment, the bidirectional backup valve 6946 is a single valve for permitting or stopping fluid flow.

It should further be appreciated by those skilled in the art that the valve as described in the above description is a " bypass " or " bi-directional " Valves are thus referred to as " bypass valves " when these bypass components, e.g., the catapult. In addition, these are referred to as " bipolar valves ", which simply direct the flow in at least two directions. However, bypass and outgoing valves may be structurally identical.

In one embodiment, the bi-directional valve used in the present invention is a bi-directional valve that is biased against the orifice by a mechanism contained within the dialysis device to stop the flow having fluid contact with the remaining fluid circuit, As shown in Fig.

Bidirectional valves 6945 and 6946 may be used to change the mode of operation for the blood treatment system. Referring to Fig. 69C, the fluid flow in the blood circulation path 6920 and the dialysis water circulation path 6925 is shown. Because the system is operating in the hemofiltration mode, the spent dialysis tubing 6903 is connected to the drain port and the new dialysis tubing 6904 is connected to the new ultra pure water and injectable grade dialysis reservoir 6952. New dialysate through a ball-valve drip chamber 6953 travels through a heater bag 6954 to flow to a new dialysis tubing 6904. The remaining components and fluid pathways of the blood and dialysate circulation paths 6920 and 6925 allow new dialysate or supplemental fluids to be introduced into the dialysate circulation path 6925 in blood filtration since the spent dialysate is not drained and reused And is similar to that of FIG. 69B. Also, in the infusion solution subsystem, components 6942, 6950, 6941, and 6951 are not used.

The blood circulation path 6920 includes an interlocking blood pump 6921 which draws arterial blood mixed with the impurities of the patient along the tube 6901 and pumps the blood through the dialyzer 6905. Optional pump 6907 injects an anticoagulant, e. G., Heparin, into the blood stream containing the impurities. The pressure sensor 6908 is disposed at the inlet of the blood pump 6921 and the pressure sensors 6909 and 6911 are disposed upstream and downstream of the dialyzer 6905. The purified blood from the dialyzer 6905 is pumped back through the tube 6902 through the blood temperature sensor 6912, the air remover 6913 and the air (bubble) sensor 6914 to the patient's vein. The pinch valve 6916 is also disposed to completely stop the blood flow and prevent air from reaching the patient when air is sensed by the bubble sensor 6914 in the upstream line of the pinch valve 6916 .

The dialysis water circulation path 6925 includes two dual-channel dialysis water pumps 6926 and 6927. The dialysis water pumps 6926 and 6927 respectively extract the spent dialysate solution from the dialyzer 6905 and extract the new dialysate solution from the reservoir 6952. The spent dialysate from the outlet of the dialyzer 6905 is drawn through the blood leak sensor 6928 and the bypass valve 6929 to reach the bidirectional valve 6930. A pressure sensor 6931 is disposed between the valves 6929 and 6930. The ultrafiltrate pump 6932 is periodically operated to extract the ultrafiltrate waste from the spent dialysate and store it in the ultrafiltrate bag 6933 (which is periodically emptied). New dialysate from reservoir 6952 travels through flow restrictor 6935 and pressure sensor 6936 to reach bi-directional valve 6937. Those skilled in the art will realize that injection solutions and concentrates are not required in these protocols and that components 6941, 6942, 6950, 6951 associated with these functions may not be used.

The heater bag 6954 is configured to direct the ultrafiltered blood from the dialyzer 6905 back to the patient or the ultrafiltered blood from the dialyzer 6905 and valves 6945 and 6946 directly into the purified blood The temperature of the new dialysate is raised sufficiently to prevent any heat shocks, because the total temperature of the mixture of injected new dialysate is equal to the patient ' s body temperature.

Fig. 70 shows another embodiment of the fluid circulation path in which the backup anisotropic valve 6946 is not used. The blood circulation path includes an interlocking blood pump that draws arterial blood of a patient mixed with the impurities along the tube 7001 and pumps blood through the dialyzer 7005. [ A syringe or pump 7007 injects an anticoagulant, e. G., Heparin, into the blood stream containing the extracted impurities. Pressure sensor 7008 is disposed at the inlet of the blood pump and pressure sensors 7009 and 7011 are disposed upstream and downstream of the manifold segment. The purified blood from the dialyzer 7005 is pumped through the tube 7002 through the blood temperature sensor 7012, air remover 7013 and air (bubble) sensor 7014 back to the patient's vein. The pinch valve 7016 is also actuated to fully stop the blood flow when air is sensed by the air (bubble) sensor 7014 in the upstream line of the pinch valve 7016 to prevent air from reaching the patient Are placed before the circulating loop connection.

The dialysis water circulation path 7010 includes two dialysis water pump segments 7026 and 7027 in pressure communication relationship with the pump. The dialysis water pump segments 7026 and 7027 respectively extract dialysate consumed from the dialyzer 7005 and extract the regenerated dialysate solution from the reservoir 7034. The spent dialysate from the outlet of the dialyzer 7005 is drawn through the blood leak sensor 7028 to reach the bypass valve 7029. The flow sensor 7020 is one of the two flow sensors (the other is the flow sensor 7046) that determines the volume of the dialysis fluid flowing through the circulation path. The valve 7030 is structurally similar to the bidirectional valve and is used to bypass the dialysis water pump 7026. The valve 7030 is normally closed in the bypass direction. When the dialysis water pump 7026 is stopped, the valve 7030 is opened to induce flow around the pump 7026. A pressure sensor 7031 is disposed between the flow sensor 7020 and the valve 7030. During normal flow, spent dialysate is pumped through pressure sensor 7040, tube 7003, and adsorbent cartridge 7015 where spent dialysate is cleaned and filtered. The washed / filtered dialysate then enters storage 7034. The ultrafiltrate pump 7032 is periodically operated to extract the ultrafiltrate from the spent dialysate and store the ultrafiltrate in a periodically emptied ultrafiltrate (not shown).

The regenerated dialysate from the reservoir 7034 is passed through a bypass valve 7041 to a tube 7004, a flow restrictor 7035, a dialysis water temperature sensor 7044, (7046) and pressure sensor (7036). When the individual channels of the bypass valves 7029, 7045 and 7041 are activated, they induce the regenerated dialysate to bypass the dialyzer 7005. The infusion and concentrate streams from the infusion and concentrate reservoirs 7050 and 7051 are delivered by the infusion and concentrate pump segments 7042 and 7043 to the cleaned dialysate And the spent dialysate downstream of the flow sensor 7020.

The bidirectional valve 7045 determines in which mode the system is operating. Thus, in one mode of operation, the bidirectional valve 7045 allows the regenerated dialysate to enter the dialyzer via tube 7060 to enable general hemodialysis of the patient ' s blood. In another mode of operation, the bidirectional valve 7045 is operated to direct the fluid flow of the ultrapure water injection grade dialysis fluid to the venous line and directly to the patient. Thus, the multipurpose valve allows the mode of operation to be switched between hemofiltration and hemodialysis. For example, in the blood filtration shown in FIG. 69C, an injectable grade of fluid is passed through three valves, directly to the blood stream to which valve 6946 connects to the post-dialyzer. In this mode, valve 6945 prevents dialysate fluid from entering the lower port of the dialyzer. As shown in FIG. 69B, in hemodialysis, valve 6946 is closed and valves 6947 and 6945 send dialysate fluid to the dialyzer. It should be noted that the embodiment of FIG. 69b utilizes multiple valves and pump swapping to adjust the fluid volume, and the embodiment of FIG. 70 uses flow sensors 7020 and 7046 to adjust the fluid volume.

As discussed above, the valve is preferably implemented in the manifold using an elastic membrane at the flow control point, which is selectively closed if desired, by protrusions, pins, or other members extending from the manifold machine. In one embodiment, fluid closure is enabled using a secure low energy magnetic valve.

The valve system includes a magnetic displacement system that is lightweight and consumes minimal power, which makes it ideal even when a portable kidney dialysis system uses a disposable manifold for a fluid circuit. The system can be used with an orifice of any structure. In particular, the orifices are any holes, openings, cavities, or partitions of any type of material. This includes piping, manifolds, disposable manifolds, paths in channels and other paths. Those skilled in the art will appreciate that the valve system described in this invention will be implemented as a disposable manifold by placing the displacement member and magnet on the valve cryogen manifold on the valve as desired, as discussed further below. The actuator is also separate from and separate from the disposable manifold, and is generally part of the non-disposable portion of the kidney dialysis system.

Functionally, the valve of the present invention has two stable states: an open and a closed state. This works by using a magnetic force to move the displacement member relative to the diaphragm, thereby creating sufficient force to press the diaphragm against the valve seat and closing the orifice with the diaphragm. Closure of the orifice blocks fluid flow. The use of a reverse process, that is, the use of magnetic forces to move the displacement member away from the diaphragm and thereby release the diaphragm from compression against the valve seat opens the orifice and causes fluid flow.

Although the present invention is discussed in terms of the preferred embodiment shown in FIGS. 71A and 71B and the undesirable embodiment shown in FIG. 73, the present invention relates generally to any use of valves in a kidney dialysis system having the following characteristics: B) state change requires energy input; c) state maintenance does not require energy input; d) when it is changed, the valve is closed. One state is changed using magnetic force to change the position of the displacement member to open or close.

71A and 71B, the valve system 7100 of the present invention is used to regulate fluid flow through a fluid flow channel 7102, which in turn provides a valve annular orifice 7103 And bounded by the valve seat 7104 to form the valve seat 7104. Orifice 7103 is a compartment of any hole, aperture, cavity, or any type of material, particularly a manifold, disposable manifold, channel, and other path 7110. The valve 7100 is shown in an open state. The components of the valve system include an orifice closure member, a displacement member, a mechanism for moving the displacement member, an optional optical sensor, a coil driver circuit, and a driver with a coil.

In one embodiment, the orifice closure member includes a diaphragm 7106 that compresses against the valve seat 7104 to close the valve annular orifice 7103 when pressed by the displacement member, as discussed below. In the open state, the main body of the diaphragm 7106 is separated from the valve seat 7104 by the gap 7198. [ In one embodiment, the diaphragm 7106 is made from a soft material such as silicone rubber. The diaphragm 7106 should maintain its shape over time, temperature and drive. Valve 7100 relies on diaphragm material 7106 to return the displacement member (compressive force) to its uncompressed shape when removed in the open state.

Those skilled in the art will recognize that the orifice closure member may include any combination of spring, compressible, or non-compressible structures, which when closed by the displacement member closes the orifice. In one embodiment, valve seat 7104 may be molded with a manifold. Suitable materials for the valve seat are polycarbonate, ABS and similar plastics. The valve orifice 7103 has a diameter in the range of 0.1 to 0.3 inches (and more particularly 0.190 inches) in the preferred embodiment. The orifice dimensions may be increased to increase the flow for alternative applications of the present invention, or alternatively may be reduced to reduce flow for alternative applications.

In one embodiment, the displacement member includes a plunger cap or housing 7110 that is aligned with the diaphragm 7106 when the valve is in the open position, but substantially compresses the diaphragm 7106 Do not. On the inside of the plunger cap 7110, a compliant component, for example, a spring 7112 and a head 7199 of a plunger are located, which are separated by an air gap 7114. The plunger cap 7110 is surrounded on its outer side by a fluid seal 7120, which in one embodiment is a thin, soft silicone rubber washer. In one embodiment, the plunger cap 7110 is forced against the silicone rubber washer and compresses the washer to form a fluid seal 7120. When in the closed position, the plunger cap 7110 is not pressed against the washer so that it is loosely positioned in the end cap 7130 without being compressed. Spring 7112 is any elastic or compliant material and, in one embodiment, includes a wave spring.

Plunger cap 7110, inner spring 7112, air gap 7198, plunger head 7199, plunger body 7140, and core 7142 are the components of a preferred displacement member of the present invention. In one embodiment, the plunger body 7140 is approximately 0.5 to 2.5 inches long with an outer diameter in the range of 0.1 to 0.2 inches (more particularly 0.122 inches). It will be appreciated that the plunger body 7140 may be any load structure of any length depending on the application. The plunger body 7140 is positioned within the annular core 7142 which has one larger end and one smaller end and includes any one of a variety of known to those skilled in the art, including epoxy, screw attachment, pinned, Gt; core. ≪ / RTI > The outer diameter of the larger end of core 7142 ranges from 0.3 inches to 0.5 inches (and more particularly 0.395 inches), the thickness ranges from 0.03 to 0.15 inches (and more particularly 0.05 to 0.10 inches), the length is 0.50 to 1.75 Inch length (and more particularly 1.05 inch length). The small end of the core 7142 has a diameter of 0.1 to 0.4 inches, and more particularly 0.25 inches.

Surrounding at least a portion of the small end of the core is a coil bobbin 7195 that holds the coil 7148 in place and provides dimensional stability to the coil 7148. [ The gap is preferably between the coil bobbin 7195 and the core 7142. The size of the gap is approximately 0.01 to 0.03 inches (and more particularly 0.02 inches). The coil bobbin 7195, in one embodiment, is a glass-filled nylon structure, which must be non-metallic and non-ferromagnetic. The coil bobbin 7195 is an annular structure having an outer diameter of sufficient size to provide a tight fit to the housing bore and an inner diameter sufficient to move and sufficient to surround the core to withstand some degree of thermal expansion. The two end caps 7130 and 7160 sandwich the bobbin 7195 in place and prevent it from moving or slipping, especially when exposed to electromagnetic forces.

The plunger body is made of metal or non-metallic material, such as brass or glass fiber, and the core is also made of metal, especially steel. Preferably, the plunger body is non-magnetic and the core body is ferrous-magnetic. As discussed further below, plunger body 7140 and core 7142 are moved by a mechanism to move the displacement member.

The mechanism for moving the displacement member includes a housing that includes a large magnet component, a small magnet component, and a portion of the magnet and displaceable member, i.e., the plunger body 7140 and the core 7142. 71A and 71B, the mechanism for moving the displacement member includes a large magnet end cap 7130, a large magnet 7132, an elastic material 7134, a gap (not shown) for holding and aligning a large magnet, 7197, a coil 7148, a small magnet component 7162, a small magnet mount and end cap 7160, and an elastic material 7164.

The large magnet end cap 7130 includes a large magnet part 7132 and a coil bobbin 7195 in place within a housing 7170 referred to as a drive body having a borehole through which the components described herein are disposed. ). The large magnet part 7132 needs to be properly aligned with the core 7142, the plunger body 7140, and the small magnetic component 7162 to ensure proper movement of the displacement member. Both end caps 7130 and 7160 secure coil bobbin 7195 and coil 7148 in the correct position.

In addition, a mounting plate can be used to occupy and hold the end cap 7130. [ In one embodiment, the mounting plate is positioned vertically and flushes the sides of the end cap and between the end cap and the bore. The mounting plate has a hole therein, which is approximately the same diameter as the smaller diameter of the end cap. The clamping mechanism holds the body against the plate, or alternatively the plate can be permanently secured using any bonding technique known to those skilled in the art. Unlike the prior art, for example US Pat. No. 6,836,201, in a preferred embodiment, the magnet is located inside the bore but not outside, and provides a bearing for the plunger, as discussed below.

The large magnet component 7132 is separated from the core 7142 by a gap 7197 and an elastic material 7134, such as a silicone washer, which in one embodiment is 0.3 to 0.5 inches (and more particularly 0.37 inches) And a thickness of from 35 to 45 (and more particularly 40) durometers, of an outer diameter of 0.1 to 0.3 inches (and more particularly 0.188 inches), an inner diameter of 0.005 to 0.015 inches (and more particularly 0.01 inches) . The small magnet component 7162 is separated from the core by a resilient material 7164, e.g., a silicone washer, which in one embodiment has an outer diameter of 0.1 to 0.4 inch (and more particularly 0.24 inch) (And more particularly 0.188 inches), a thickness of 0.005 to 0.015 inches (and more particularly 0.01 inches), and a durometer of 35 to 45 (and more particularly 40). The small magnetic component 7162 is held within the housing 7170 by the small magnet mount and end cap 7160 and is properly aligned. A small magnet end cap screw 7172 is also provided to occupy and hold the small magnet end cap 7160 in place.

71A, the valve system of the present invention includes a coil driver circuit board 7150 including a coil 7148 that drives a driver and preferably includes a small screw, coil driver connector 7154, and a core 7196 through an optical sensor 7152 that senses the position of the large end of the actuator body 7170. [ Coil 7148 is provided to cause a change in magnetic field to cause movement of core 7142 and plunger body 7140. [ In one embodiment, the coils are approximately 0.05 to 1.5 inches long (and more particularly 1 inch in length), have an outer diameter of 0.35 to 0.55 inches (and more particularly 0.46 inches), and 0.15 to 0.35 inches (and more particularly 0.26 inches) And has six layers of wire 29 AWG wire.

Various elastic materials used in the mechanism for moving the displacement member and the displacement member provide a "soft" stop for movement of the rod 7140 when the valve is opened or closed. In particular, this provides that the movement of the core does not damage the magnet.

The large magnet component 7132 may be a single magnet, or, in a preferred embodiment, a plurality of magnets, e.g., three magnets. The small magnet component 7162 may also be a single magnet or may comprise a plurality of magnets. In one embodiment, the magnet is preferably made of Alnico, samarium cobalt, neodymium, rare earth or ceramic magnets. In one embodiment, the large magnet 7132 has an outer diameter of 0.2 to 0.5 inches (and more particularly 0.375 inches), an inner diameter of 0.05 to 0.3 inches (and more particularly 0.125 inches), and a diameter of 0.2 to 0.5 inches 0.375 inches) in length. In one embodiment, the small magnet 7162 has an outer diameter of 0.15 to 0.4 inches (and more particularly 0.25 inches), an inner diameter of 0.05 to 0.3 inches (and more particularly 0.125 inches), and an inner diameter of 0.15 to 0.4 inches 0.25 inches). ≪ / RTI > Larger magnets 7132 are used closer to the orifice closure member since they are necessary to create a sufficient counter force against the valve seat. Further, even if the magnets have different sizes, the driving force caused by the driving coil is substantially the same, thereby enabling a simple coil driver circuit.

In one embodiment, the rod, plunger, or other elongated member 7140 uses the center hole of the magnet as a linear bearing. Accordingly, the central hole of the magnet should preferably have a bearing surface, for example chromium with minimal friction or any smooth hard surface. The gap is disposed between the coil bobbin 7195 and the core 7142 due to the thermal expansion of the bobbin, the bobbin clip creepage over time, and the bobbin, core and magnet tolerances. However, under all operating conditions, the gap should be sufficient to allow the plunger body 7140 to move freely without engaging at the magnet and coil openings. In a preferred embodiment, the gap is approximately 0.01 to 0.06 inches (and more particularly 0.02 inches) at room temperature.

71B, the valve system 7100 of the present invention compresses the orifice closure member, e. G., The diaphragm 7106, thereby blocking the valve annular orifice 7103, 7104 to regulate the flow of fluid through the fluid flow channel 7102. In the closed state, the main body of the diaphragm 7106 is compressed against the valve seat 7104, thereby substantially eliminating the gap 7198 (see Fig. 71A).

As soon as immediately adjacent to the diaphragm 7106, the displacement member compresses the diaphragm 7106. In particular, the plunger cap 7110 moves to compress the diaphragm 7106. The plunger cap 7110 moves because it moves the core body 7142 toward the magnet component 7132 with a large change in magnetic field. The core body 7142 stops moving when the core head 7196 moves through the gap 7197 (Fig. 71A) and stops at the elastic material 7134 positioned adjacent to the large magnet part 7132. Fig. Movement of core 7142 also moves plunger body 7140, which is coupled to core 7142. The movement of the plunger body 7140 causes the plunger head 7199 to move within the plunger cap 7110, through the gap 7114 (Fig. 71A), and compresses the spring 7112. Fig. After a certain degree of compression, the plunger cap 7110 moves and compresses the diaphragm 7106. The movement of the plunger cap 7110 creates a new gap 7192 between the resilient material 7120 and the cap body 7110 positioned adjacent the large magnet end cap 7130. [

A coil driver circuit 7150, a coil connector 7154, a coil 7148, a coil bobbin 7193, a small end cap screw 7172, an optical sensor 7152 And the small magnet end cap 7160 are the same. It will be appreciated, however, that by movement of the core 7142, a gap 7195 is formed between the smaller end of the core 7194 and the elastic material 7164 located adjacent to the smaller magnetic component 7162. [

To close the valve, it will be appreciated that the displacement member exerts a force on the orifice closure member, e.g., diaphragm 7106. The required force from the displacement member for deforming the diaphragm to the point at which the diaphragm contacts the valve seat is substantially linear and can be modeled as a linear spring. However, the force requirement increases exponentially as the diaphragm compresses into the valve seat. As a result, the force profile for the displacement member becomes non-linear and more complex. There are thus a number of unique problems associated with the design of the valve and the hard stop of the displacement member, the tolerance between the various parts of the orifice closure member, and the displacement mechanism. The displacement mechanism makes it possible to deliver a nonlinear force profile without permanently deforming the diaphragm. This means that this mechanism should only deliver the correct amount of force.

As discussed above, the displacement member includes a rod, plunger, or other elongate member that is coupled to another structure, referred to as a core, which has a larger diameter and is pressurized against another structure, such as a magnet face, It can function as a stopper when it is turned on. Those skilled in the art will recognize that the displacement member or movable member is not limited to a rod and cylinder form. Conversely, it may include a non-cylindrical structure, a single piece, or multiple pieces welded or otherwise joined together in any other manner. In short, the displacement member may include several different structures, and movement of the end member may exert the required force on the orifice compression member in a reliable and consistent manner.

For example, referring to Figure 73, another less preferred embodiment is shown. For renal dialysis applications, these embodiments typically do not reliably maintain the valve in a closed state. The displacement member 7300 includes a housing 7305 including an electromagnet 7310 having a substantially cylindrical structure and a bore hole 7315 passing therethrough. Electromagnet 7310 is fixedly positioned centrally within housing 7305 by non-magnetic spacer 7320, which in one embodiment is an end cap. The end cap has two purposes: to hold the magnet in place and to sandwich the coil in place. In one embodiment, components 7331 and 7320 comprise a first single piece and components 7305 and 7320 comprise a second single piece. The cylindrical ferromagnetic core 7325 having the first face 7323 and the second face 7324 has a bore 7315 and a portion of the core 7325 between the first face 7323 and the second face 7324, To be linearly slidably fitted. Second surface 7324 is sufficiently larger than bore 7315, thereby limiting the linear motion of core 7325. In one embodiment, the second side has a different size than the first side to create sufficient magnetic force to hold the valve in the closed position. The core 7325 enables left and right linear sliding movement within the bore 7315.

Two different sized magnets 7330 and 7335 are also attached to and in the two end caps 7331 and 7332 of the housing 7305. The first side 7323 of the core 7325 contacts the first magnet 7330 to form a first stable state of the displacement system 7300 and the second side 7324 of the core 7325 is displaced And contacts a larger magnet 7335 to form a second stable state of system 7300. [ The arrangement of the permanent magnets 7330 and 7335 is designed to be within the diameter of the housing 7305 by reducing the size of the displacement system 7300. [ The first rod 7340 connected to the first face 7323 of the core 7325 passes through the first magnet 7330 and thereby protrudes from the housing 7305 at one end, A second rod 7345 connected to the second face 7324 passes through the second magnet 7335 and thereby protrudes from the housing 7305 at the other end. The rods 7340 and 7345 may be fabricated from non-corrosive, non-magnetic materials known in the art, such as, but not limited to, brass. One embodiment has two rods connected to two sides of the core, but in another embodiment, only one rod is connected to one of the sides of the shuttle.

Those skilled in the art will appreciate that the magnetic forces exerted by the electromagnet 7310 on the core 7325 can be controlled by changing the holding forces of the permanent magnets 7330 and 7335 so that the displacement system 7300 can change from the first stable state to the second stable state. Will be perceived as high enough to overcome. Those skilled in the art will also recognize that the rod / plunger 7345 moves with the core 7325, thereby creating a motive force for compressing or decompressing the orifice closure member. However, this embodiment was determined to be inferior to the first embodiment because it did not sufficiently maintain the closed state.

Several design features of the orifice closure member that operate in conjunction with the displacement member and mechanism should be appreciated. First, referring to FIG. 74 and as discussed above in connection with FIGS. 71A and 71B, the gap 7408 includes a plunger cap 7404 and an orifice closure member 7405, particularly a first diaphragm surface 7405 ). Gap 7408 is in the range of 0.040 to 0.070 inches, and more particularly about 0.055 inches. The diaphragm can be modeled as a spring (K _V2 ) that includes silicon, preferably 0.040 inch thick silicon, and has a spring constant of 270 lbf / in. The second diaphragm surface 7406 is separated from the valve seat 7407 and is acted upon by a magnetic force modeled as a spring K _V1 having a spring constant of approximately 22.5 lbf / in and a thickness of approximately 0.047 inches.

The rod 7404 transfers the force generated by the magnetic force of the core 7401 to the magnet 7403 modeled by the spring K _P which is in the closed state blocked by a washer, Is separated from the core head 7401 and is separated from the core head 7401 by about 0.110 inch in the open state. This silicone washer provides a force modeled as a spring K _SL . Core 7401 is coupled to rod 7404. When the valve is operated, the rod 7404 moves in the direction of the valve seat 7407 because the core coupled to the rod moves in the direction of the large magnet 7403.

Referring to FIG. 74, K _v2 and K _{SL correspond} to elastic materials, for example, silicon, which are modeled as rigid springs. When the valve is in the closed state, it will be recognized that there are two important positions. The first is the position of the rod to the diaphragm, and the second is the position of the core face to the large magnet. When the valve is closed, the rod presses on the valve diaphragm with sufficient force to withstand at least 600 mmHg back pressure generated in the fluid passageway of the kidney dialysis system. In this embodiment, the fluid pressure can reach 2600 mm Hg, and this system 7400 is designed to maintain the diaphragm firmly pressed against the valve seat to 2600 mm Hg up to 2600 mm Hg to seal the orifice do.

Additionally, when the valve is closed, the large side of the core is pulled close to the large magnet or pulled directly against it. The magnetic force of the core with respect to the large magnet forms the force that the rod applies to the orifice closure member, e.g., the diaphragm. In order to generate a constant and reliable force, the gap between the core face and the face of the large magnet must be constant. Accordingly, it is preferable to dispose the elastic material 7402 between the core surface 7401 and the magnet surface 7404. The elastic material will have a nonlinear spring constant and will compress until the force obtained for the elastic material is equal to the magnetic force. When a rod applies force to the diaphragm through the core, the core will experience the resulting force. In order for a static condition to occur, the sum of these forces on the core must equal zero. The elastic material is also provided to protect the magnet surface from chipping or fracture during drive.

76, when the valve 7600 is in the closed state, the core heads 7605 and 7602 move away from the small magnet face 7601 (from position 7602a to position 7602). When in position 7602, the core head is separated from the small magnet 7601 by a resilient material 7617, for example a silicone washer having a thickness of approximately 0.015 inches. When in position 7605, the core head will move approximately 0.140 +/- 0.20 inches, including a distance of 0.45 +/- 0.005 inches, while the rod 7608 will not move, and the elastic material 7616 (e.g., A silicon washer having a thickness of approximately 0.015 inches), which separates the core head 7605 from the large magnet face 7606. [ The large magnet 7606 is also separated from the load head 7607.

When the valve is in the open state, the large magnet 7606 is separated from the load head 7607 by a resilient material 7615, for example, a silicone washer having a thickness of approximately 0.015 inches. When the valve is in the closed state, the large magnet 7606 is moved from the load head 7607 by an elastic material 7615, for example a silicon washer having a thickness of approximately 0.015 inches and a distance of approximately 0.055 +/- 0.10 inches. Separated. When the valve is closed, the load head 7607 moves from close to the large magnet 7606 and the elastic material 7615 to close to the valve seat 7610. Specifically, the load head 7607 compresses the diaphragm 7608 to move the elastic material 7609 (e.g., silicon having a thickness of about 0.040 inches) and also to press the valve seat 7610. [ This causes the valve to close with a force of approximately 14N.

The configuration of the displacement member and mechanism for the orifice closure member and the tolerances described herein provide a diaphragm displacement profile 7500 as shown in FIG. 75, which is an application that must withstand at least 600 mmHg back pressure, such as a kidney dialysis system Lt; / RTI > Referring to Figure 75, a representative diaphragm displacement profile 7501 is provided wherein the force 7502 exerted by the displacement member is provided on the y-axis and the corresponding diaphragm displacement is provided on the x-axis . The inflection point on this curve 7503 specifies when the diaphragm begins to be pressed against the valve seat. To the left of the inflection point 7503, the diaphragm is pressed to bend toward the valve seat, but there is no substantial compression for the valve seat. To the right of the inflection point 7503, the diaphragm is bent relative to the valve seat to deform the diaphragm material and affect a good seal against fluid pressure.

Another important component of the displacement mechanism system is the actuator system 7200 shown in FIG. During the drive process, the coil 7205 is energized and a magnetic field is formed, thereby creating a magnetic force facing the small magnet attraction. As the magnetic force is formed, the core discussed above begins to move to a closed position (large magnet). Immediately after the core moves past the point of no return, the attraction on the core of the large magnet overcomes the attraction of the small magnet. In order to prevent counter forces caused by the valve diaphragm from overcoming the attraction of large magnets, the gap is provided as discussed above.

The coil design is made in coil form and magnet wire 7210. The size of the coil shape size is preferably based on the commercially available coil shape, the pulse current capability of the power source, and in particular the desired driving force and supply voltage. The driving force is proportional to the amp-turn rating of the coil. In one embodiment, it is desirable to limit the coil current to 6 amps or less.

Important factors in coil design include the number of layers, packing factor, wire diameter and coil resistance. In one embodiment, the present invention uses a bobbin having six wire layers and a bobbin flange diameter of about 0.010 inches and spacing between the final layers. Depending on the coil resistance of 3.5 +/- 0.5 Ohm and the insulation requirements of heavy poly nylon, the wire size is approximately 29 AWG. Any size coil type can be used.

The circuit used to induce the coil is an H-bridge circuit that can switch current for open and close operation. The H-bridge circuit is derived by a unique pulse width modulated (PWM) signal. The PWM signal is used to generate a cosine current pulse through the coil. The duration of the cosine pulse is related to the mass and counter force of the core. A preferred embodiment does not use a bipolar DC power switch or sense switch, but rather uses an electronic drive cosine to move the plunger in the desired direction, determine the position of the core, Thereby generating a waveform, thereby changing the state of the valve.

Optionally, valve system 7100 uses a sensor, preferably an optical sensor 7152, to determine the state (open or closed) of the valve, as shown in Figures 71A and 71B as component 7152 . This can be accomplished by orienting the optical sensor 7152 between a valve open state and a valve closed state at a position that is sufficiently different in reflectivity or other optical properties. For example, when the valve is closed, in one embodiment, the large end of the core 7196 is oriented with respect to the elastic material 7134 and the large magnet part 7132. [ The large end of the core 7196 has a width wide enough to be sensed by the reflective optical sensor 7152, but the optical sensor 7152 is not very wide to have position resolution. The optical sensor 7152 will be placed on the outside of the displacement member / mechanism and viewed through its body, which is preferably made of a transparent polycarbonate. The wavelength of the optical sensor 7152 may be in the near-infrared range (NIR) to have good transmission through the polycarbonate body. Those skilled in the art will appreciate that the sensor may be selected to suit any material structure, but that it includes an appropriate filter. Here, the optical sensor 7152 is preferably embedded therein with a long pass optical filter for NIR sensitivity.

Functionally, as shown in FIG. 71A, when the core is in the open position, the large end of the core 7196 moves out of the field of view of the optical sensor 7152, It will be seen by the optical sensor. As shown in FIG. 71B, when the large end of the core 7196 is in the clock, there will be a reflection observed by the sensor 7152, thereby indicating that the core is in the closed position. Those skilled in the art will appreciate that the sensor 7152 may be configured to sense a large amount of reflectance from the core when the valve 7100 is in the open position and to detect very low reflectivity when the valve 7100 is in the closed position ≪ / RTI > A person skilled in the art can also sense when the gap is present and when the gap is free so that the sensor 7152 can be positioned close to the gap to indicate the condition of the valve 7100. [

In this embodiment, the substantially planar surface of the manifold diaphragm causes a functional system, but the responsivity of such a system is delayed. In detail, the gap or gap between the sensors or pins in the dialysis device, and the diaphragm surface form the reactive curve shown in Fig. The reaction does not appear until the inflection point 7503 when the diaphragm is pressed against the valve seat. However, in certain embodiments, more immediate reactivity may be desired. Thus, in other embodiments, the manifold may include one or more diaphragms having elevated portions or protrusions on the outer surface of the dialyzer pin or sensor that are configured to be in sufficient intimate contact with the dialyzer pin or sensor from which the gaps present in the above- . Gap, or dead space causes improved linearity of the system's response to movement of the pin to the diaphragm.

FIG. 71C is a cross-sectional illustration of an embodiment of a manifold diaphragm 7106 having an elevated convex surface 7120. FIG. The surface 7120 of the diaphragm 7106 starts at the same level of the manifold 7107 and increases the height h over its length 1 relative to the height of the manifold 7107 and thereafter decreases. In one embodiment, the length l of the diaphragm is measured to be approximately 0.625 inches to 0.675 inches. In one embodiment, the increase in overall height h in the middle with respect to the exterior surface of the manifold 7107 is 0.03 to 0.04 inches. In one embodiment, the thickness t of the diaphragm is measured to be 0.03 to 0.04 inches relatively constant over its length l. The convex diaphragm would be desirable to remove the bubble when the transducer is in contact with the diaphragm surface. However, it is difficult to create and maintain a convex diaphragm structure due to the generated heat.

Small dome or protrusions within a substantially flat diaphragm surface are more resistant to heat and easier to fabricate. FIG. 71D is a cross-sectional illustration of an embodiment of a manifold diaphragm 7106 having elevated convex protrusions 7128 positioned centrally within a substantially planar periphery 7125. FIG. The peripheral portion 7125 of the diaphragm 7106 has a surface height that is substantially flat with the outer surface of the peripheral manifold 7107. There is an elevated protrusion 7128 with a pronounced step increase in height relative to the periphery 7125 substantially centered at or about the center of the diaphragm 7106. [ The protrusion 7128 has a convex surface 7120 designed to contact a pin or sensor. In one embodiment, the overall length l of the diaphragm is measured to be approximately 0.625 inches to 0.675 inches. The length l ₁ of the protrusion is measured from 0.125 to 0.15 inches, and in one embodiment within the sensing diameter of the pressure transducer is 0.185 inches. The length of the peripheral portion (l ₂ ) on each side of the projection is measured from 0.25 to 0.2625 inches. In one embodiment, the total height h of the protrusions is measured from 0.03 to 0.04 inches. The increase in height is capped by the curved surface of the protrusion. In one embodiment, the thickness t of the diaphragm is relatively constant over the entire length l thereof and is measured from 0.03 to 0.04 inches. In one embodiment, the raised protrusion 7128 represents 10% to 40%, preferably greater than 19% to 23% of the total diaphragm surface.

In another embodiment, both the periphery of the diaphragm and the raised protrusion have a convex surface, but have a different overall height relative to the manifold outer surface. FIG. 71E is a cross-sectional illustration of an embodiment of a manifold diaphragm 7106 having elevated convex protrusions 7128 located centrally within an elevated convex periphery 7127. FIG. The peripheral portion 7127 of the diaphragm 7106 has an increasing surface height relative to a substantially flat outer surface of the peripheral manifold 7107. The peripheral portion 7127 includes a convex surface 7123. At the center of the diaphragm 7106 there is an elevated protrusion 7128 with a distinct, single increase in height relative to the convex periphery 7127. The protrusion 7128 has a convex surface 7120 configured to contact a pin or sensor. In one embodiment, the overall length l of the diaphragm is measured to be approximately 0.625 to 0.675 inches. The length l ₁ of the protrusion is measured from 0.125 to 0.15 inches and is within 0.15 inches of the sensing diameter of the pressure transducer in one embodiment. The length of the peripheral portion (l ₂ ) on each side of the projection is measured from 0.25 to 0.2625 inches. In one embodiment, the total height h of the protrusions is measured from 0.03 to 0.04 inches. In one embodiment, the height h ₂ of the protrusion is measured to be 0.10 to 0.02 inches less than the inflection on each side of the periphery defining the end of the periphery and the onset of the protrusion. The height h ₁ of the periphery is measured approximately 0.02 inches higher than the manifold outer surface. The increase in height is capped by the curved surface of the protrusion. In one embodiment, the thickness t of the diaphragm is relatively constant over the entire length l thereof and is measured from 0.03 to 0.04 inches. In each of the above embodiments, the diaphragm may have a non-uniform thickness throughout its entire length l, but it will be appreciated that this is not preferred.

By configuring the entire diaphragm surface (which may include the periphery and protrusions) to include a central zone having a relatively constant thickness and an increased height relative to the rest of the diaphragm, the linearity of the pressure response is improved. A first protrusion extending upward in a bent manner within the boundary of the peripheral portion and a diaphragm having a second protrusion centered in the first protrusion extending upward in a bent manner in the boundary of the first protrusion, It will be appreciated that further variations of the described embodiments are encompassed. In this manner, the protrusions can be stratified within each other to create a multi-step-wise increase in height towards the center of the diaphragm at the periphery. The same number of such protrusions and steps are possible and are limited only by the quality of the pressure response and the fabrication capability of the design.

In use, as shown in Figure 77, the valve is initially in one of two states, open or closed. When the valve is in the open state 7701, the first step of closing the valve is to power the coil driver circuit 7702, thereby passing the magnetic field generated by the coil to the core, And forms a weak attracting force between the large magnet and the large end of the core. As the displacement member begins to move (7703), the attraction of the small magnet increases as the attraction of the small magnet increases. The displacement member moves to the return point 7703 and then the displacement member 7704 closes the gap 7704 and compresses the orifice closure member or septum 7705 against the valve seat 7706. Compression of diaphragm 7706 causes diaphragm to close orifice 7707 and valve 7708 to close.

When the valve is in the closed state 7709, the first step of opening the valve supplies energy to the coil driver circuit 7710, thereby causing the magnetic field generated by the coil to pass through the core, Creates an opposing magnetic force between the magnets, and creates a weak attractive force between the small magnet and the small end of the core. As the displacement member begins to move (7711), the larger magnet attraction is reduced as the larger magnet attraction increases. The displacement member moves to the return point (7711), and then the displacement member releases the pressure of the diaphragm 7712 away from the valve seat 7713. The orifice is opened by being no longer covered by the diaphragm 7714. The displacement member returns to its original position and re-forms gap 7715, thereby returning to open state 7716. [

Since the first and second stable states of the core are maintained even when the power to the electromagnet is turned off, the displacement system requires a continuous power supply to maintain the state and, as compared to prior art actuators, Low power consumption and low heat generation.

SALINE RINSE BACK

Referring to Figure 86, a method and system for performing a brine rinse bag safely and efficiently is shown. Typically, the brine rinse bag provided for flushing the system with saline desorbs the tubular segment 8658 connecting the dialysis blood circuit to the patient at the connection 8651 and connects the tubular segment 8658 to the connection points 8652 and 8653, To the brine source 8602 via the inlet port 8602. However, these conventional methods have disadvantages including breaching of the sterile connection. It will be appreciated that the connection point may be any type of connection including luer connections, snap pits, needleless inserts, valves or any other type of fluid connection.

Another method for saline rinse bags involves connecting saline supply source 8602 to connection point 8653 via connection point 8652 while maintaining connection to the patient. While this prevents collapse of the sterile connection, it exposes the patient to a brine fluid flow which may contain bubbles. There is a risk that an excessively large air bubble will form because the air bubble detector is not typically present in the tubular segment 8658 between the saline connection point 8653 and the connection point 8651 for the patient, There is a risk that it will enter the patient ' s blood stream and cause substantial damage.

Alternatively, a preferred method for performing a brine rinse bag is to maintain a blood circulation connection between the patient and the dialysis system via the tubular segment 8658, which is connected to the manifold 8600 at port C (8605) And connects to the patient at connection point 8651 and fluidly connects brine source 8602 to manifold 8600 at port D 8606. With regard to the fact that the patient is still fluidly connected to the dialysis system, the brine can flow by gravity or applied pressure to the manifold 8600 via port D (8606) adjacent port C (8605). The brine flow flushes the manifold 8600 with brine and flows through the tubular segment 8658, in some cases port C 8605, out of the manifold 8600 and into the patient via connection 8651 ≪ / RTI > Because manifold 8600 is installed in the controller unit and is thus configured to detect bubbles in the fluid stream present in port C 8605 because there is a bubble detector in area 8654 proximate to port C 8605, , The brine present in the manfold 8600 and directed to the patient will be monitored for bubbles through the bubble detector in the area 8654. If bubbles are detected, the alarm will sound and thereby signal to the patient that the bubble should be extracted from the access point 8610 using a syringe or disconnected from the system. Thus, this method and system for performing brine rinse-back still monitors the presence of bubbles and keeps the sterilized connection informed.

Improved hardware architecture

Embodiments of the dialysis system described herein further include a hardware architecture that provides a faster method of terminating system operation. Typically, when an alarm condition is encountered during a dialysis operation or when the user wishes to terminate a task, the instructions issued in the higher application layer must go through multiple lower layers to actively terminate the hardware operation . This architecture places the user in unnecessary risk of a delayed outage that may not be allowed in the main application.

78, the dialysis system includes at least one processor and memory for storing program instructions that, when executed, communicate with the software application layer 7805. [ The software application layer 7805 is in data communication with a plurality of field programmable gate arrays (control FPGAs) 7815 responsible for controlling the various pumps, sensors and valves, Or interface with a master controller 7810 in data communication with a plurality of field programmable gate arrays (safety FPGAs) responsible for monitoring for conditions exceeding the allowable operating parameters 7820.

The control FPGA 7815 includes a controller 7810 that controls the operation of all system components including pumps, sensors, and valves, passes information specific data for further processing and / or displays it on the application layer 7805, And the safety FPGA 7820, which monitors operating conditions for the alarm condition, e.g., operating parameters that do not meet or exceed one or more pre-defined thresholds, .

Controller 7810 or application layer 7805 may generate one or more instructions to terminate the operation in the event that control FPGA 7815 generates an alarm condition or generally indicates data indicating a need to terminate or abort the operation And the like. Independently, however, the safety FPGA 7820 can receive data and issue instructions directly, or it can terminate, stop, or otherwise change state of operation of one or more valves, pumps, or sensors . The safety FPGA 7820 may be configured to receive data directly after receiving data directly from the control FPGA 7815 or when it is received directly by the controller 7810 or directly by the application layer 7805 Can operate. By receiving data from the control FPGA 7815 and receiving instructions from them without a mediating layer between the application layer 7805 and the controller 7810, the system is in a state of accepting alarm conditions Stop, interrupt, or other modification or user command more quickly and reliably.

Graphical User Interfaces

Embodiments of the dialysis system further include an interface through which the user interacts with the system. As discussed above, the controller unit includes a display for displaying a graphical user interface to the user. The interface allows the user to accurately measure and verify the prescription additive and provide the authenticity and preservability of the disposables used in the system, as well as the ability to check the authenticity and preservability of the prescription additive.

As discussed above, the dialysis system may be located on the shelf above the controller unit, inside the storage unit of the portable dialysis system, on the side of the bottom unit close to the holder for the adsorbent cartridge or infusion liquid, And a scale that can be incorporated into the < / RTI > The measurement reading obtained by the digital scale is displayed by the graphical user interface (GUI) shown on the display incorporated in the upper controller unit.

In one embodiment, the controller unit is programmed in accordance with a user ' s prescription. This can be done by an initial setup in which the user sequentially arranges packets of all prescription additives on the scale tray. Measurements made by digital scales are recorded and stored in internal memory. Thus, the controller can access data relating to the name of the additive and the prescribed weight. Thus, when a packet of any prescription additive is placed on a scale for measurement before initiating the dialysis process, the controller compares the measured weight to the prescribed weight stored in the internal memory. In case of any inconsistency between the measured weight and the correct or prescribed weight, the controller derives the GUI to display an alarm or an audio generation unit to generate an acoustic alarm. Accordingly, such an alarm can be a visual, e.g., flashing, error message on the GUI screen and can also be performed by a sound alarm. Alternatively, the user may be prevented from continuing the dialysis setup process.

Figure 79 illustrates a representative table of data for prescription additives that can be stored as files, flat files, or tables in an internal memory of a portable dialysis system. Column 7901 describes the contents of the packet, and column 7902 represents the corresponding weight. As can be seen from column 7902, the weight difference between the different packages can be read by the digital scale, as a few grams. In one embodiment, the digital scale of the present invention is designed with a weight resolution of the order of 0.1 gm, which provides a resolution advantage of greater than 5 times, and more preferably a 10 times resolution advantage, when providing the weight of the additive . This resolution is sufficient to distinguish between commonly used additives.

Optionally, the structure of the digital scale is designed such that the metering process is not affected by the manner in which the user places the packets of the prescription additive on the scale. This is because the structure of the scale in the present invention includes several weight-sensitive members at various suspension points. In one embodiment, for example, the scale includes three sensors on a three point suspension. The total weight is calculated by the scale system as the sum (SUM) of the weights measured by all the sensors. The advantage of using this formula is that the pocket weight need not be homogeneously distributed on the scale platform. This will not affect the accuracy of the weighing done by the scale, even though the pocket is placed on the scale tray slightly off to one side, flattened, or clumped. That is, the user is not constrained in a manner in which packets are placed on the scale.

It will further be appreciated that the sensor weight can be determined using any calculation method known in the art. In one embodiment, a processor in scale and data communication relationship receives a data read from the scale and determines the weight as follows:

Sensor_weight t (i) = K1 (i) * ADC (reading) + K0 (i)

Weight of sensor (weight of sensor + weight of sensor + weight of sensor + weight of sensor 3) / 4

As discussed above in connection with FIG. 16, the portable dialysis system has an exposed reader 1605, such as a bar code reader or RFID tag reader, which may be used to read codes or tags on the packets of prescribed additives . For initial setup, the user would preferably read all the code / tags on the packet of the prescription additive by reader 1605. The user is assisted through an initial GUI message that is passed through the reader 1605 to be read to the user for each packet of prescription additive. If so, the reader obtains the identification information for the additive and delivers the identification information to the internal table stored in the memory. After this initial setup, each time the prescription additive is added to the dialysis product prior to initiating the dialysis, the identification information of the associated pocket (read by the reader 1605) identifies the identity of the additive already stored in the internal table during initial setup . This helps to ensure that the correct additive is selected for use with the dialysate and helps dispense any spurious additive. The contents of the internal table may be generated by manual entry of data relating to the identity and weight of the additive, or by remote access to a specification detailing the identity and amount of the additive.

In one embodiment, the GUI of the present invention is generated by a plurality of program instructions stored and executed by a processor residing in a controller unit. One set of program instructions is designed to show the process for identifying and quantifying the amount of additive used by the user. The first GUI screen allows the user to expose the barcode on the additive bag to the barcode reader. Those skilled in the art will recognize that this identification mechanism may be a barcode, RFID tag or other electronic tag, and that the reader may be a barcode reader, an RFID tag reader, or other electronic tag reader. The reader reads the coded information, processes it using the processor, and sends the processed information to the memory. The memory has a programmatic routine that translates the processed information into an identification of the additive. In one embodiment, such translations are facilitated by a table that matches various identifiers with specific additive names. Such a table may be manually entered prior to the procedure or downloaded to the controller via a wired or wireless connection from the server.

Immediately after the additive identification is obtained, the GUI instructs the user to convey the identification of the additive to the user and place the additive on the scale. The digital scale meters the additive and delivers the measured weight to the second table. The second table maps the additive identification to the expected weight. Such a second table may be manually entered before the procedure or downloaded to the controller via a wired or wireless connection from the server. When the additive identification and the measured weight match, the user is instructed to open the packet and pour the contents to the proper location. This process is repeated for all additives. In one embodiment, the user may not continue the process if there is a mismatch between the identification of the pocket and its weight, or if the coded identification of the pocket is unreadable or unknown. Accordingly, the system can use a digital scale together with a bar code or tag reader, which either: a) uses the digital scale itself, or b) ensures that the user has all the desired additives in the water and the correct additive is used and falsified or not Provides a one-step or two-step verification mechanism.

Referring to Figure 80, a flowchart depicting another process (8000) for initiating dialysis therapy is described. In one embodiment, the controller unit 8001 comprises at least one processor and a memory in which a plurality of program instructions are stored. When executed by a processor, program instructions generate a plurality of graphical user interfaces that are displayed on a controller display, which directs the user through a series of measures designed to reliably acquire and measure the required additives for use in dialysis therapy do. A first graphical user interface is formed through which the system may initiate an additive accounting process 8001. The initial prompt may be through a specific icon to initiate the process or may occur as part of a larger system setup.

A second graphical user interface is then created 8003, which preferably includes a visual image of the actual additive package to visually compare the user's desired additive to the product the user holds, It is expressed in graphic form. Thereafter, the user is prompted to indicate whether he wants to check the additive by using a bar code scan or by weight (8005). If the user indicates, for example, that he wants to use a barcode scan by pressing an icon, a third graphical user interface is formed 8007 to allow the user to pass through the barcode scanner and through the first additive. Thereafter, the user registers the readings by passing the additive preferably past the bar code scanner in any order. It will be appreciated that the barcode scanner may include light, e.g., red light that changes color to green, for example, upon successful reading.

If the system successfully reads the bar code, it processes the code by checking the code for the table stored in memory (8009). A table stored in memory allows the bar code to be associated with a particular additive. Immediately after a particular additive is identified, a second graphical user interface as described above is updated (8011) with a checkmark or highlight to specify that the additive is successfully scanned and the user is instructed to set the additive separately, . This process is repeated for all additives (8019). In one embodiment, immediately after all additives are highlighted or checked, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, immediately after all the additives are highlighted or checked, the system displays a graphical user interface informing the user that all additives have been registered, after which the user manually navigates the system as the next step in the dialysis setup or initialization process . Although the term bar code is used, it will be appreciated that any electronic tagging or labeling system may be used.

If the bar code is not recognized during random scanning step 8009, the additive does not have a bar code, or the user prefers to identify the additive using weight, as opposed to scanning, To the user (8013) to place the first additive in the container. The scale measures the weight of the additive package (8015) and compares the measured weight to the specific additive and the table of weighted values in order to recognize the additive. Immediately after being recognized, the second graphical user interface is updated 8017 with a check mark or highlight to instruct the user to set the additive separately, as described above, and the additive is successfully scanned. This process is repeated for all additives (8019). In one embodiment, immediately after all additives are highlighted or checked, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, immediately after all the additives are highlighted or checked, the system displays a graphical user interface informing the user that all additives have been registered, after which the user manually navigates the system as the next step in the dialysis setup or initialization process . Although the term bar code is used, it will be appreciated that any electronic tagging or labeling system may be used.

In the event that the additive is not recognized, the user is informed that the additive is not part of the treatment process and the appropriate additive is to be metered. In other embodiments, the user may be prevented from continuing the initialization or setup process if the user fails to scan or quantify the recognized additive.

Those skilled in the art will appreciate that although the above-described attestation procedures have been described for prescription additives, the same procedure can also be extended to disposable parts, such as adsorbent cartridges and other disposables, used with the dialysis system.

It will be further appreciated that the process of scanning and metering additives can be integrated and automated. As discussed above, the user may be allowed to initiate an additive metering process and a display of the items required for treatment may be displayed. The user places the additive on a scale with a near or integrated bar code reader. In one embodiment, the user causes the additive to be placed in a specific location or arrangement so that the bar code can be read properly. Upon placing the additive on a scale having an integrated or combined bar code reader, the bar code reader scans the additive, attempts to recognize the bar code, and, if recognized, checks or enhances the identified additive on the display . If the bar code reader does not identify the additive, or if the system requires an additional supplemental check, or if the system is to acquire or otherwise record weight information, the scale may be weighted and the additive . If identified, the system processes the item by checking or highlighting the identified additive on the display. As such, scale measurements and bar code readers can occur without moving the additive from one position or place to another position or place.

The additive may be a holding container, chute, cylinder, box, bucket, or aggregator that automatically drops, locates, or otherwise positions each additive to a suitable location on the scale / may be inserted into the staging area. Thus, the user can place all of the additives in a single vessel, activate the system, and sequentially locate and automatically identify each additive on the scale. The user can either remove each additive after each additive is recognized, or all additives can be processed first.

It will further be appreciated that the additive can be added to the system automatically after identification, manually after identification, and before the blood filter and / or sorbent cartridge is installed. In one embodiment, the upper or lower unit of the portable dialysis system also preferably has a direct connection to the network to facilitate remote prescription confirmation, compliance vigilance, and other remote service operations, For example, an Ethernet connection or a USB port. The USB port also allows direct connection to ancillary products such as a blood pressure monitor or a hematocrit / saturation monitor. This interface is electrically insulated, thereby ensuring patient safety regardless of the quality of the interfacing device.

In another embodiment, the dialysis device includes an interface in the form of a graphical user interface with a touch screen button, a physical keypad or a mouse, which initiates a task in the dialysis device loaded with the manifold in either the treatment mode or the priming mode Lt; / RTI > When commanded to operate in the treatment mode, the controller generates a signal (responsive to the treatment mode command) to switch the manifold valve from the opened priming state to the closed treatment state. When commanded to operate in the priming mode, the controller generates a signal (responsive to the priming mode command) such that the manifold valve is switched from the closed treatment state to the open priming state. Those skilled in the art will appreciate that all of the above-described control and user command functions are triggered by the introduction of one or more processors that execute programs that implement the above-described instructions stored in local memory.

When properly operated, the system may operate at least in a priming mode and a treatment mode, which may include other operating modes (e.g., hemodialysis, blood filtration, or simply non-priming mode). 84, a dialysis system 8400 operating in a dialysis mode is shown to include a dialysis machine 8402, an adsorbent recycling system (e.g., cartridge) 8412, a manifold 8410, And a reservoir 8415 into which new dialysate is injected back into the manifold 8410 through the port. In operation, the blood enters the blood line 8401, enters the manifold 8410 through the port, enters the diaphragm 8402 through the diverticulum valve 8421 in the first position. The purified blood is discharged from the dialyzer 8402 through the outlet port 8403 and through the port of the bidirectional valve 8422 in the first position and into the manifold 8410 through the port. The blood proceeds through the manifold and proceeds through the plurality of valves 8417 as described above in connection with the manifold 8410 and proceeds to the blood line 8423 from the port and into the patient.

At the same time, the infusion fluid traveling from the source 8416 travels through the port to the manifold 8410, through the manifold 8410, through the other port, and into the reservoir 8415, The water is transferred to the dialyzer 8402 via a line 8424, which is a dialysis liquid. After proceeding through the dialyzer 8402 the dialysis material proceeds through the out-line 8425 and reverses through the port to the manifold 8410 through the port to the adsorbent-based dialysate recovery system 8412 do. The regenerated dialysate travels back through the port through the manifold 8410 and is recycled through the dialyzer 8402 with the new dialysate as desired and desired. To manage dialysate fluid flow, a reservoir 8415 is used to store the regenerated dialysate as and when needed. In one embodiment, the reservoir has the ability to maintain 5 liters of dialysis and maintain 10 liters of dialysate and effluent from the patient.

85 and in reference to Figure 85, the dialysis system 8500 operating in the priming mode includes a dialyzer 8502, an adsorbent recycling system (e.g., cartridge) 8512, a manifold 8510, An infusion solution supply source 8516 and a reservoir 8515. In operation, the blood line from the patient (e. G., 8401 to 8401) to the manifold 8510 is not connected, thereby allowing blood not to flow or flow into the manifold 8510. [ Rather, the proceeding dialysis product from the source 8515 proceeds to the manifold 8510 through a plurality of ports and through a line 8524, which is a dialysis fluid connected to the bidirectional valve port 8522.

In a preferred embodiment, the single bi-directional valve 8517 is introduced into the physical body of the manifold 8510 and is manipulated to switch between the therapeutic mode of operation and the starter mode of operation, as discussed above. In this embodiment, the manifold 8510 can be activated or moved from a first position (e.g., a closed position) to a second position (e.g., open position) Lt; RTI ID = 0.0 > 8517 < / RTI > As a result of such a flow path change, the blood circulation path and the dialysis water circulation path which are fluidly blocked from each other when the valve is closed are disposed in fluid communication with each other. Preferably, additional valves or switches need not be manipulated in order to achieve this state change, i.e. to make the separate blood circulation path and dialysis circuit circulation fluidly connected.

The valve switch is used to physically manipulate the mechanical control on the surface of the internal fold or to control the valve condition according to the user selected mode of operation through the interface between the dialysis device with the controller and the integrated valve interface on the surface of the manifold, Including, but not limited to, manipulation through the operation of a dialysis machine that alters the temperature of the dialysis machine.

In priming mode, valve 8517 will open, thereby advancing the dialysate fluid through the pump through manifold 8510, through tubes 8524 and 8503 to the dialyzer 8502, Is advanced through the bidirectional valve port 8522 out of the dialyzer and back through the bidirectional valve port 8521 and tube 8525 to the manifold 8510 and advanced out of the manifold 8510. Accordingly, in the priming mode, the valve 8517 causes the dialysis water to circulate through the blood circulation path to place the blood circulation path and the dialysis water circulation path. Functionally, the manifold 8510 is disposed by manipulating the state of the bidirectional valve 8517 in the priming mode.

After a certain volume of dialysate is pumped into the blood circuit and through the blood circuit, the two-way valve is closed. The pumping of dialysate may or may not be continuous. In successive cases, the new dialysate only circulates through the dialysate circulation path. In the blood circulation path, the remaining dialysate remains. In order to purge the dialysate from the blood circuit, the patient is connected from the "patient line" 8401, shown in FIG. 84 and commonly referred to as the arterial access line. "Patient line side" 8423, commonly referred to as a venous return line, extends into the waste container or is connected to the patient.

By placing the system in a treatment mode, the blood from the patient is vented to the blood circuit and travels to the manifold, through the pump, out of the manifold, through the dialyzer, back to the manifold, and back out of the manifold. Thereby, depending on the connected state of the vein return line, the blood causes the residual priming fluid to be " traced " through the blood circulation path to remove any remaining air pockets in the process and to either the waste container or the patient. After the blood is completely filled with the blood circulation path, the system fixes the blood pump or the user manually stops the pump. If not already connected, the venous return line is then connected to the patient and treatment continues.

In other embodiments, a filter, for example a 0.22 mu filter, can be used to help remove any remaining undesired material if the adsorbent-canister is not necessarily suitable for producing sterile dialysis. In one embodiment, the filter is located in-line with the reservoir input line, close to port E of the manifold, and is used during both priming and operation.

By using this priming system, it is possible to prevent the use of additional and separate sets of disposables to just prime the blood side of the circulation path. In particular, this method can be used to remove the need for a separate brine source, for example a 1 liter brine bag, and thus also a dual-lumen spike or single lumen spike used to connect the blood line to the brine, Eliminating the need for piping and connectors to separate brine sources.

Disposable Kits

Embodiments of the dialysis system described herein are designed to use a plurality of disposable components. 81, in one embodiment, disposables 8106 for use in the present system are conveyed in a package that is preassembled on tray 8105. [ The tray 8105 is disposed on top of the work area of the controller unit 8101, thereby enabling easy access to and management of important disposables, which are particularly important to home users. The controller unit 8101 is waterproof to prevent impregnation and damage to the upper controller unit 8101 in the event of liquid spillage.

In one embodiment, the kit 8200 includes a manifold 8202, a dialyzer 8201, and a pre-attached tubing 8203 all. 82, disposable kit 8200 includes a dialyzer 8201, a manifold 8202, a pipe 8203, a valve 8204 (as part of a manifold), a storage bag 8205, All of which are pre-attached and arranged by the user for direct installation on the dialysis machine.

More particularly, disposable components, particularly full disposable blood and dialysate circulation passages, are pre-packaged in kits (including dialysis machines, manifolds, tubing, storage bags, ammonia sensors and other components) Is installed by opening the front door of the unit (as discussed above), installing a dialyzer, and installing the manifold in a manner that can align the manifold with non-disposable components such as pressure sensors and other components. A plurality of pump shoe integrated into the interior surface of the front door facilitates disposable components to be mounted. Only the manifold has to be inserted, and the pump piping need not be sandwiched between the roller and the shoe. This simple packaging method makes it possible to easily load disposable items and clean the system. This can also make the flow path properly arranged and ready for use. In operation, the upper unit is attached to a lower unit having a reservoir.

Optionally, disposable components, and in particular manifolds, include an electronic-based lockout ("e-lockout") system. 83 is a functional block diagram illustrating one embodiment of an e-lockout system of the present invention. In one embodiment, the e-lockout system 8300 detects disposable items 8302, e.g., disposable manifolds, disposable adsorbents used in dialysis regeneration, and / or identification data 8306 embedded in the dialyzer And a reader 8301 for reading. The identification data 8306 may be stored on the disposable item 8302 by a barcode, RFID tag, EEPROM, microchip, or any other identifying means that uniquely identifies the disposable item 8302 used in the dialysis system 8303. [ have. The reader 8301 is correspondingly a bar code reader, an RFID reader, a microchip reader, or any other reader corresponding to an identification technique used as is known to those skilled in the art. In one embodiment, the reader 8301 is coupled to a transceiver for wireless connection to a remote database 8305 via a network 8304, such as the Internet or any other public or private network known to those skilled in the art. In another embodiment, the reader 8301 is directly aligned with the identification data 8306.

The database 8305 located away from the dialysis system stores a plurality of information about the disposable items 8302 that can be used in the system 8303. This information can be used to determine a corresponding disposable item, for example authenticity, usefulness in terms of whether the item is good in working conditions, or whether the item is defective, in some cases, its expiration period, and / And unique identification data 8306 along with information about when it is recalled to the manufacturer due to any other such numerical-ancillary information that has been proven to be valid.

In operation, when the disposable item 8302, e.g., a dialyzer, manifold or blood filter cartridge, is loaded into the system 8303, the reader 8301 reads the identification data 8302 stored in the item 8302 via the identification data 8306 embedded in the item 8302 Disposable item 8302 is detected. This identification data 8306 is read by the reader 8301, which also requests additional information about the item 8302 stored thereon based on the identification data 8306 or identifies the item 8302 based on the identification data 8306 To communicate with the database 8305 either wired or wireless to verify the validity or integrity of the database 8302.

For example, in one embodiment, the dialyzer cartridge 8302 identified by the reader 8301 may be returned by the manufacturer due to some defects. This reply information is stored on the database 8305 and returned to the reader 8301 as a result of a request signal sent by the reader 8301 via the network 8304 to the database 8305. As a result of the number of times information received from the database 8305, the microprocessor controlling the blood purification system supported by the system 8303 prevents the user from continuing the therapy. This is achieved, in one embodiment, by delaying the functionalization of the pump to propel the fluid through the fluid circulation path of the blood purification system 8303. Additionally, the acoustic / visual alarm can also be displayed with this effect.

In another example, the dialyzer cartridge 8302 identified by the reader 8301 may not be authentic. As a result, the microprocessor will not allow the functionalization of the blood purification system of system 8303. Thus, the e-lockout system 8300 of the present invention prevents use of the system 8303 when the disposable article 8302 attached to the manifold 8303 is in a compromised state.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the true scope of the invention, . In addition, various modifications may be applied to specific situations or materials taught by the present invention without departing from the scope of the present invention. Accordingly, it is intended that the invention not be limited to the particular embodiment described as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims (20)

A diaphragm integrated in a disposable manifold for use in a dialysis machine and configured to be pressurized by components within the dialysis device and external to the disposable manifold, And a convex outer surface that is fixedly attached to the manifold at a first end and a second end, the distance between the first end and the second end defining a length and height of the septum, Wherein the diaphragm at the second end has the same height as the manifold and the height of the convex outer surface is increased from the first end to the first height for the manifold and the height of the convex outer surface is at the first height The diaphragm decreases to the second end. The diaphragm of claim 1 wherein the first height of the diaphragm is 0.03 to 0.04 inches with respect to the manifold. The diaphragm of claim 1, wherein the diaphragm has a thickness along a length from the first end to the second end, the thickness being substantially constant along the length. The diaphragm of claim 1, wherein the thickness of the diaphragm is 0.03 to 0.04 inch. The diaphragm of claim 1 wherein the total length of the diaphragm is 0.625 to 0.675 inches. A manifold comprising at least one diaphragm of claim 1. A diaphragm incorporated into a disposable manifold for use in a dialysis machine and configured to be pressurized by components within the dialysis device and external to the disposable manifold,
a) a first substantially planar surface having a first end and a first bend, wherein a distance between the first end and the first bend defines a length and height of the first planar surface, A first substantially planar surface having one end fixedly attached to the manifold and further wherein the height of the first planar surface is substantially equal to the height of the manifold;
b) a convex outer surface extending from the first curve portion of the first plane surface and projecting outwardly, the convex outer surface extending from the first curve portion to the second curve portion, the distance between the first curve portion and the second curve portion being Wherein the convex surface of the first curve and the second curve has the same height as the first plane surface and the height of the convex outer surface is greater than the height of the convex surface of the first curve, 2 < / RTI > height, the height of the convex outer surface decreasing from the second height to the second curve; And
c) a second substantially planar surface extending from the second curve to the second end, the distance between the second curve and the second end defining the length and height of the second plane surface, and the second end Wherein the height of the second planar surface is substantially equal to the height of the first planar surface, and wherein the length of the second planar surface is greater than the height of the second planar surface Wherein the first substantially planar surface is substantially the same as the first substantially planar surface. 8. The diaphragm of claim 7, wherein the second height of the convex outer surface is 0.03 to 0.04 inches with respect to the first substantially planar surface. The diaphragm of claim 7, wherein the diaphragm has a thickness along a length from the first end to the second end, the thickness being substantially constant along the length. 8. The diaphragm of claim 7, wherein the thickness of the diaphragm is 0.03 to 0.04 inches. 8. The diaphragm of claim 7 wherein the total length of the diaphragm from the first end of the first planar surface to the second end of the second planar surface is 0.625 to 0.675 inches. 8. The diaphragm of claim 7, wherein the convex outer surface is 0.125 to 0.15 inches long, the length of the first planar surface and the length of the second planar surface is 0.25 to 0.2625 inches. A manifold comprising at least one diaphragm of claim 6. A diaphragm incorporated into a disposable manifold for use in a dialysis machine and configured to be pressurized by components within the dialysis device and external to the disposable manifold,
a) a first tapered surface having a first end and a first bend, the distance between the first end and the first bend defining a length of the first tapered surface, Wherein the first inclined surface has a first height at the first end and a second height at the first curve, and wherein the second height of the first inclined surface is greater than the second height of the second manifold, The first inclined surface being greater than the first height of the first inclined surface relative to the first inclined surface, and wherein the first height of the first inclined surface is substantially equal to the height of the manifold;
b) a convex outer surface extending from the first curve portion of the first inclined surface and protruding outward, the convex outer surface extending from the first curve portion to the second curve portion, the distance between the first curve portion and the second curve portion Wherein the height of the convex surface at the first curve and the second curve is equal to the second height of the first tilted surface and the height of the convex outer surface defines the height of the convex surface at the first curve, A convex outer surface increasing to a second height of the convex surface relative to a second height of the first beveled surface, the height of the convex outer surface decreasing from the second height to the second bend of the convex surface; And
c) a second tapered surface extending from the second curve to the second end, wherein a distance between the second curve and the second end defines a length of the second tapered surface, Wherein the second inclined surface has a first height at the second curve and a second height at the second end, and wherein the first height of the second sloping surface is greater than the second height of the second manifold, Wherein the first height of the first inclined surface is greater than the second height of the second inclined surface relative to the fold, and wherein the second height of the second inclined surface is substantially equal to the first height of the first inclined surface, Wherein the first height of the bi-sloping surface is substantially equal to the second height of the first sloping surface, and wherein the length of the second sloping surface is substantially equal to the length of the first sloping surface And a second inclined surface. 15. The method of claim 14 wherein the second height of the convex outer surface is between 0.01 and 0.02 inches relative to the second height of the first beveled surface and the first bevel of the second beveled surface, Wherein the second height of the first beveled surface and the first height of the second beveled surface are approximately 0.02 inches with respect to the manifold. 15. The diaphragm of claim 14, wherein the diaphragm has a thickness along a length from the first end to the second end, the thickness being substantially constant along the length. 15. The diaphragm of claim 14, wherein the thickness of the diaphragm is 0.03 to 0.04 inches. 15. The diaphragm of claim 14, wherein the total length of the diaphragm from the first end of the first tapered surface to the second end of the second tapered surface is 0.625 to 0.675 inches. 15. The diaphragm of claim 14, wherein the convex outer surface has a length of from 0.125 to 0.15 inches, the length of the first inclined surface and the length of the second inclined surface is from 0.25 to 0.2625 inches. 15. The manifold of claim 14, wherein the manifold comprises at least one diaphragm.

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