RU2574367C2 - Portable dialysis machine - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to medical equipment. A dialysis machine comprises a control unit accommodating a door, a casing with a panel forming a buried cavity for receiving the above door, a collector receiver set tightly attached to the above panel, and a processor for controlling the blood flow through the collector and a dialysis unit. A basic unit is configured to attach to the control unit and detach from the same, and to share data with the control unit. The basic unit comprises a flat surface for receiving the liquid container. The container is configured in a liquid connection with the connector. A weighing device is connected to the flat surface. A heating element is configured in a thermal coupling with the container. The processor is configured to control the blood flow from the patient through the dialysis unit and the collector and from the liquid container through the dialysis unit and the collector. Disclosed are versions of the dialysis machine.

EFFECT: invention provides easy installation, transfer, transportation and maintenance of the dialysis machine.

25 cl, 86 dwg

Description

CROSS REFERENCE

This application is a partial continuation of US patent application No. 12 / 237,914, filed September 25, 2008, which is based on provisional patent application US No. 60 / 975,157 filed September 25, 2007 for priority.

This application is also a partial continuation of US patent application No. 12 / 610,032, filed October 30, 2009, which is based on provisional patent application US No. 61 / 109,834 filed October 30, 2008 for priority.

This application is also a partial continuation of US patent application No. 12 / 324,924, which is based on, for priority, provisional patent application US No. 60 / 990,959, entitled "System and Method of Changing Fluidic Circuit Between Hemodialysis Protocol and Hemofiltration Protocol", filed 29 November 2007, and provisional patent application US No. 61 / 021,962, under the same name, filed January 18, 2008

This application is also a partial continuation of US Patent Application No. 12 / 249,090, which relies on, for priority, US provisional patent application No. 60 / 979,113, entitled “Photo-Acoustic Flow Meter,” filed October 11, 2007.

This application is also a partial continuation of US patent application No. 12 / 575,449, which is based on, for priority, provisional patent application US No. 61 / 103,271, filed October 7, 2008 for priority.

This application is also a partial continuation of US patent application No. 12 / 751,930, which is based on, for priority, provisional patent application US No. 61 / 165,389, filed March 31, 2009

This application is also a partial continuation of US patent application No. 12 / 705,054, which is based on, for priority, provisional patent application US No. 61 / 151,912, filed February 12, 2009

This application is also a partial continuation of US patent application No. 12 / 875,888, which is part of US patent application No. 12 / 238,055, which is based on, for priority, provisional patent application US No. 60 / 975,840, filed September 28, 2007

This application is also a partial continuation of US patent application No. 12 / 210,080, which is based on, for priority, provisional patent application US No. 60 / 971,937, filed September 13, 2007

This application is also a partial continuation of US patent application No. 12 / 351,969, filed January 12, 2009.

This application is also a partial continuation of US patent application No. 12 / 713,447, which is based on, for priority, provisional patent application US No. 61 / 155,548, filed February 26, 2009

This application is also a partial continuation of US patent application No. 12 / 575,450, which is based on, for priority, provisional patent application US No. 61 / 103,274, filed October 7, 2008.

All of the above descriptions of the invention are fully incorporated herein by reference.

FIELD OF TECHNOLOGY

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

BACKGROUND

Blood purification systems that are used for hemodialysis, hemodiafiltration or hemofiltration provide extracorporeal circulation of blood through an exchanger having a semipermeable membrane. Such systems further include a hydraulic system for circulating blood and a hydraulic system for circulating saline or dialysate containing certain electrolytes of blood at approximately the same concentrations as in the blood of a healthy subject. However, most traditionally available blood purification systems are characterized by very large sizes of difficulty in operation. Additionally, the design of these systems makes them cumbersome and not conducive to the use and installation of disposable components.

Standard therapeutic dialysis using a device installed in hospitals contains two phases, namely (a) dialysis, in which toxic substances and slags (usually small molecules) pass through a semipermeable membrane from the blood into the dialysis solution, and (b) ultrafiltration, where the pressure drop between the blood line and the dialysate line, more precisely, the lowered pressure in the last line, leads to a decrease in the water content in the blood by a predetermined amount.

Dialysis procedures using standard equipment are burdensome and expensive, not to mention the fact that the patient has to visit the dialysis center for a long time. Although portable dialysis systems have been developed, traditional portable dialysis systems suffer from certain disadvantages. Firstly, they are not sufficiently modular, which makes it difficult to install, move, transport and maintain systems. Secondly, the systems are not simple enough for reliable, accurate use by the patient. System interfaces and methods of using disposable components are subject to misuse and / or errors when used by patients. For a portable dialysis system to be truly effective, it must be easy to use by people who are not medical professionals, even though one-time and data entry is limited enough to prevent inaccurate use.

One traditional design of dialysis systems uses a single-pass system. In single-pass systems, the dialysate is passed through the blood in the dialyzer once, and then disposed of. Single pass systems have many disadvantages associated with the use of large amounts of water. Firstly, based on the fact that the retention coefficient of the R.O. system (reverse osmosis) is 50%; a water flow rate of at least 1000 to 1500 ml / min is required. Secondly, to ensure a continuous flow of 100 to 800 ml / min of purified water, a water purification system is required. Thirdly, an electric circuit, designed for at least 15 A, is required for pumping from 100 to 800 ml of water per minute, and fourthly, a floor drain or any other tank capable of receiving at least 1500 ml / min of used dialysate and water remaining after RO.

Conventional systems are also less reliable due to the need to use a large number of pipes containing the piping of the treatment systems, which increases the risk of leakage and breakage. In addition to the difficulty in transportation due to its large size, traditional dialysis machines also suffer from a lack of flexibility. For example, sorbent hemodialysis procedures have a specific set of equipment requirements that are not inherent in the hemofiltration process. Thus, it is useful to have common equipment components, for example, a pumping system, the use of which allows you to operate the dialysis system, both in hemofiltration mode and in hemodialysis mode.

Additionally, there is a need for a portable system that can efficiently provide dialysis system functionality in a safe, economical, and reliable manner. In particular, there is a need for a compact dialysis fluid reservoir system that can meet the requirements of a dialysis procedure for fluid delivery, while at the same time combining various other important functions, such as heating a fluid, measuring and monitoring a fluid, detecting a leak, and detecting disconnect.

In particular with regard to detection of disconnection, efficient detection of disconnection of the return line is difficult, since most known methods are based on monitoring and detecting a change in pressure in the return venous conduit. The disconnection of the return line usually occurs due to the situation of pulling out the needle. Since the needle usually provides the highest flow resistance in the extracorporeal blood line, the change in pressure in the return line due to disconnection of the needle is negligible and not easy to detect. The pressure drop is also very low in cases when the catheter is disconnected from the patient's body, leading to the separation of the return line. Therefore, detecting a disconnection in the return venous blood stream using pressure as an indicator or metric is unreliable and can result in serious damage. Additionally, one should not rely on methods based on the detection of air bubbles as an indication of separation, since separation in the venous return line does not lead to air suction into the return line. Therefore, there is a need for an improved apparatus and method for detecting disconnection in a venous return line. Additionally, there is also a need for a device and method that does not require placement of any additional elements, for example, a wet pad, at the needle insertion site.

Additionally, in the prior art there are no satisfactory mechanisms for maintaining volumetric accuracy during the dialysis process, which could be easily implemented with reasonable costs. Most traditional methods for maintaining the volumetric accuracy of saline and effluent are unsuitable for use with disposable devices. One traditional approach to maintaining volume accuracy involves weighing saline and effluent. However, this approach is difficult to put into practice. Another method of the prior art involves the use of volumetric surge chambers for dialysis systems. Such cameras, however, are complex and expensive to manufacture and are also unsuitable for disposable devices. Another known method involves the measurement of volumetric flow, but the accuracy of this method is not confirmed. In addition, this method is very difficult to implement for a dialysis system in a single use. Another traditional approach involves the use of two piston pumps to achieve volumetric accuracy. However, this approach is very difficult to implement with affordable costs in a one-time version, and is also not economical for operation with the necessary pumping volumes of about 200 ml / min. Thus, there is a need for a method and system that can be used to accurately maintain the volume of fluid introduced into and removed from the patient, and which can be inexpensively implemented.

In addition, there is a need for a multi-pass sorbent dialysis system that reduces the overall need for water compared to traditional systems. There is also a need for a manifold that can be used in a single-pass sorbent dialysis system, as well as in the multi-pass system of the present invention, which provides a lightweight design with molded flow channels for blood and dialysate to avoid a complex piping network.

It is also desirable to have a portable dialysis system that has a structural design configured to optimize the modularity of the system, which makes it easier to install, move, transport and maintain the system. It is also desirable to have system interfaces through which patients enter data or install disposable components that are configured to prevent errors in use and limited enough to prevent inaccurate use.

SUMMARY OF THE INVENTION

In one embodiment, a dialysis apparatus comprising a control unit is disclosed, said control unit comprising a door having an inner surface, a housing with a panel, said housing and panel forming a recessed area configured to receive said internal surface of said door, and a collector receiver, firmly attached to said panel, and a base unit, said base unit comprising a flat surface for receiving a liquid container, scales combined with said mentioned flat surface, a heater in thermal communication with said planar surface, and a sodium sensor electromagnetic coupling with said planar surface.

Optionally, the collector receiver includes at least one of the curly guides, pins or latches. The panel is configured to provide access to multiple pumps. The panel is configured to provide access to four peristaltic pumps aligned substantially in parallel. The inner surface contains four pump pads. When the door enters said recessed region, each of said four pump blocks is aligned with one of said four peristaltic pumps. At least one of said pumping pads is movably connected to said door by a part and a spring. The part is a bolt.

Optionally, the control unit further comprises a sensor for measuring the movement of said part, the control unit further comprises a controller for receiving a measure of movement of said part from the sensor and determining liquid pressure based on said measure.

Optionally, the apparatus is configured to perform therapeutic dialysis using approximately six liters of water, said water coming from a non-sterile source. The collector receiver is configured to receive a molded plastic base that forms a first flow channel that is hydraulically isolated from the second flow channel. Each of the aforementioned first and second flow channels has a hydraulic diameter ranging from 1.5 mm to 7.22 mm. A molded plastic base is connected to a plurality of tubes, and said plurality of tubes are connected to a dialyzer. The control unit further comprises a part connected to the outer surface of said body, said part being configured to physically receive said dialyzer.

Optionally, the base unit further comprises a part connected to the outer surface of said base unit, said part being configured to physically receive said dialyzer. Many tubes are made with the possibility of attachment with the ability to remove sorbent to the cartridge. The base unit further comprises a part connected to the outer surface of the base unit, said part being configured to physically receive the sorbent cartridge. The control unit comprises a lower surface, said lower surface comprising a first physical interface and a first data interface.

Optionally, the base unit has an upper surface, said upper surface comprising a second physical interface configured to complement said first physical interface, and a second data interface capable of interacting with said first data interface. The balance comprises a plurality of bend sensors and Hall sensors, each of said bend sensors being physically connected to said flat surface, and each of said Hall sensors is configured to record physical displacement. The sodium sensor contains a conductivity sensor.

Optionally, the conductivity sensor comprises a coil having a plurality of turns, a capacitor in electrical communication with said coil, said coil and capacitor forming a circuit, and an energy source in electrical communication with said circuit. The conductivity sensor displays a value indicating the concentration of sodium in said liquid based on the supply of energy from said energy source necessary to maintain a constant voltage across the capacitor.

Optionally, the base unit contains at least one moisture sensor. The base unit comprises a door capable of being in an open state or in a closed state, the door being brought into an open state being physically blocked when said inner surface of the door enters a recessed region. The base unit comprises a door capable of being in an open state or in a closed state, the door being physically locked in a closed state when said inner surface of the door is in said recessed region. The control unit comprises a plurality of sensors associated with the molded plastic base when said inner surface of the door is in said recessed region. At least one of the plurality of sensors comprises a pressure transducer. The pressure transducer is pressure coupled to a flexible membrane integrated in said molded plastic base.

Optionally, the control unit comprises at least one valve component associated with said molded plastic base. The control unit contains many program instructions configured to activate the valve component, the activation of said valve component causing the fluid to flow through one of two separate flow channels in said molded plastic base. The 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, said valve component comprising an opening closure member adjacent to an opening through which fluid can flow, an offset member having a first portion and a second portion, said first portion adjacent to the opening closure when the valve component is in said open position, the first magnet and the second magnet, said first and second magnets being sufficiently close to said a bias part so as to act with magnetic force on said bias part, and an actuator for generating a magnetic field to move said bias part to said first magnet, to ensure that said first portion is pressed against the hole closure part and to ensure that said hole is closed by the hole closure part.

Optionally, the first portion comprises a housing, an elastic material, a rod, and a gap between said elastic material and said rod. To determine the presence or absence of a gap, an optical sensor is provided in said valve component. The first portion comprises a rod, and said second portion of said biasing part is a metal body whose diameter exceeds the diameter of said rod. The rod is connected to the cylinder. The first magnet is larger than the second magnet. The hole closure part comprises at least one of a diaphragm, an elastic material, and a compressible material. The hole closure part is pressed against the valve seat to close said hole.

Optionally, the valve component comprises a hole closure member adjacent to the hole through which fluid can flow, said hole closure member being pressed against the valve seat when the valve is in the closed position, a movable member that can physically move relative to said hole closure member, said movable part moves from a first position when said valve is in an open position to a second position when said valve is in said closed position, wherein, in said second position, the movable part is pressed against the opening part of the hole to ensure that said opening closing part is pressed against the valve seat, the first magnet and the second magnet separated by a gap, said first magnet and second magnet generating a magnetic field in the gap wherein said magnetic field has a direction and an actuator capable of generating electromagnetic force, said electromagnetic force reversing the direction crumpled magnetic field.

Optionally, the dialysis machine includes an optical sensor provided for determining the presence or absence of a gap. The first magnet and the second magnet provide a supporting surface for moving said movable part. The first magnet having a first pole is larger than said second magnet having a second pole. The first pole and the second pole are repelled from each other, and the first magnet and the second magnet are configured so that the aforementioned first pole and second pole are facing each other.

Optionally, the control unit further comprises a valve having a first stable state and a second stable state, said valve comprising magnets, wherein supplying energy to said valve creates a magnetic force by which the biasing part moves in said control unit, and moving said part bias leads to a transition between the first state and the second state, and the maintenance of the aforementioned first or second state does not require energy.

Optionally, the molded plastic base has an opening, said opening being closed to the fluid flow when said valve is in a first stable state, said opening being open to fluid flow when said valve is in a second stable state. The hole is closed to the fluid flow when said biasing part presses the material into said hole. At least one of the plurality of sensors is a flow meter.

Optionally, the flow meter comprises at least two probes, each of said probes having a body and a contact surface located on said molded plastic base, wherein the first of said at least two probes generates a heat wave in the fluid flowing through said molded plastic base, in response to a first heat signal, and a second of said at least two probes, records said heat wave in said liquid. The flow meter further comprises a reference signal generator, wherein said reference signal generator outputs a reference signal. The flow meter further comprises a heat source, wherein said heat source receives said reference signal from said reference signal generator, is configured to thermally couple to the first of said at least two probes, and generates said first thermal signal whose phase is obtained from said reference signal . The flow meter further comprises a temperature sensor, said temperature sensor being configured in thermal conjugation with said second probe and generating a second thermal signal whose phase is obtained from said heat wave. The flow meter further comprises a multiplier for receiving an input signal from said reference signal generator and for receiving said second thermal signal and for outputting a third signal. The flow meter further comprises a low-pass filter for receiving a signal obtained from said third signal and for receiving a reference signal from said reference signal generator, said low-pass filter modulating its cutoff frequency based on the reference signal.

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

Optionally, the flowmeter is configured to project an optical beam onto a liquid in said molded plastic base; register the resulting acoustic signal at the first point upstream and at the second point downstream in the liquid; determine a phase difference between said acoustic signal detected upstream and said acoustic signal detected downstream in a liquid; and calculate the flow rate of said fluid from said determined phase difference. The phase difference is determined by subtracting the signals representing the phase of said acoustic signal recorded upstream and downstream.

Optionally, the flowmeter comprises an optical system for projecting an optical beam into a fluid flowing through a transparent section of said molded plastic base; a first acoustic detector for detecting an acoustic signal at a first point upstream of said transparent section; a second acoustic detector for detecting said acoustic signal at a second point located downstream of said transparent section; and, a processor for determining a phase difference between said acoustic signal recorded upstream and said acoustic signal detected downstream, and for calculating from a certain phase difference of the liquid flow rate in said molded plastic base.

The processor for determining the phase difference contains a subtraction unit. The optical system is a pulsed laser system. An optical beam is projected perpendicular to the direction of flow of said liquid. The flow meter has a working measurement range from 20 ml / min to 600 ml / min. The flow meter has a working measurement range from 20 ml / min to 600 ml / min. The control unit further comprises a reader for detecting identity embedded in the molded plastic base. The control unit further comprises a temperature sensor which is arranged to be in thermal communication with the molded plastic base when said door is in said recessed region.

Optionally, the control unit comprises a disconnection monitor for determining a break in the connection of the blood line to the patient. The disconnection monitor comprises a pressure transducer coupled in pressure to the blood flow passage in said manifold, said pressure transducer generating a signal indicating a pulse signal in said blood flow passage, a heart reference signal generator, said heart reference signal generator recording and generating a signal indicating said patient pulse, a pressure transmitter data receiver, said pressure transmitter data receiver takes said signal indicating a pulse signal in said blood flow channel, a heart reference signal receiver, said heart reference signal receiver receiving said signal indicating a patient’s pulse, and a processor, said processor cross-correlating said signal indicating a pulse signal, in said flow channel for blood and said signal indicating a patient’s pulse to generate data indicating a break in the connection of the blood line with the patient.

Optionally, the disconnect monitor further comprises a controller, said controller triggering a warning signal based on said data indicating a disconnection of the blood line connection with the patient. The disconnect monitor further comprises a controller, said controller shutting down the dialysis pump based on said data indicating a disconnection of the blood line from the patient.

Optionally, the pressure transmitter non-contactly generates a signal indicating a pulse signal in said blood flow passage. The processor cross-correlates said signal indicating a pulse signal in said blood line and said signal indicating a patient’s pulse by calculating the sum of the products of the corresponding pairs of signal points indicating a pulse signal in said blood line and said signal indicating a patient’s pulse in a specified time interval.

Optionally, the disconnect monitor further comprises program instructions instructing the patient to first attach said cardiac reference signal generator before starting the dialysis pump. The disconnect monitor further comprises program instructions instructing the system to capture said signal indicative of a pulse signal in said blood flow path before starting the dialysis pump.

Optionally, the control unit further comprises a display, a balance, a barcode reader and a memory where a plurality of program instructions are stored, and when executed, said instructions generate a) a first graphical user interface for presentation on said display, said first graphical the user interface displays each supplement necessary for use in therapeutic dialysis, b) a second graphical user interface for presentation to said m a display, wherein said second graphical user interface prompts the user of said system to scan many additives using said barcode scanner, and c) a third graphical user interface for presentation on said display, said third graphical user interface inviting the user of said system to additives measured using said weights.

Optionally, the scales are digital scales. A barcode scanner provides a visual indication of a successful read. The memory further comprises a table linking a plurality of additive names to a plurality of barcodes. The memory further comprises a table linking a plurality of additives to a plurality of weight values. The first graphical user interface displays a visual representation of the packaging of the supplement. The third graphical user interface prompts the user of the said system to measure the additive using said weights only if the barcode for the additive is not recognized. The third graphical user interface prompts the user of the said system to measure the additive using said weights only if the barcode for the additive is not available.

Optionally, the control unit further comprises a display, scales comprising a plurality of magnets, an electronic reader, and a memory where a plurality of program instructions are stored, and when executed, said instructions generate a) a first graphical user interface for presentation on said display, said first graphical user interface prompts a user of said system to subject a plurality of additives to scanning using said scan ra-dimensional bar code and b) a second graphical user interface for presentation on said display, said second graphical user interface provides the user of said system to expose a plurality of additives measurement using said weights.

Optionally, when executed, the instructions further generate a third graphical user interface for presentation on said display, said third graphical user interface displaying each supplement necessary for use in therapeutic dialysis. The scales are digital scales, said digital scales generating data representing the weight of an object placed on said digital scales. Digital scales further comprise at least three bend sensors. Each of these bending sensors contains a magnet and a corresponding Hall sensor.

Optionally, the dialysis system further comprises a molded plastic base, said molded plastic base comprising a first flow channel and a second flow channel formed therein, said first flow channel and said second flow channel being hydraulically separated by a valve. The control unit further comprises a memory where a plurality of program instructions are stored, said program instructions being configured to set a first state of said valve and a second state of said valve depending on the selected operating mode. The selected operating mode is either a refueling mode or a treatment mode. The first state of the valve provides fluid communication of said first flow channel with said second flow channel. The second state of the valve provides fluid isolation of said first flow channel from said second flow channel. The dialysis system further comprises a molded plastic base, said base comprising a first conduit for introducing fluid to the patient and a second conduit for removing fluid from the patient.

Optionally, the control unit further comprises a first pump configured to operate alternately on said first conduit and said second conduit; a second pump configured to operate alternately on said second conduit and said first conduit; and a controller instructing said first pump to alternately operate on said first conduit and said second conduit and instructing said second pump to alternate operation on said first conduit and said second conduit, wherein each of said first pump and second pump is currently operating on only one the pipeline.

Optionally, the first pump allows more fluid to be pumped per unit time than the second pump. The first and second pumps alternately operate on said first and second pipelines for a time interval, said time interval being obtained from an allowable difference in the amount of liquid pumped per unit of time by said first and second pumps. The first and second pumps are peristaltic pumps. The dialysis system further comprises a limiter for equalizing the differential pressure between said first and second pipelines. The limiter is active and equalizes the pressure drop based on the measured pressure drop received from the first pressure sensor in said first pipe and from the second pressure sensor in said second pipe.

Optionally, the panel further comprises a funnel formed by two inclined surfaces leading into the channel, said channel containing at least one moisture sensor. When the door enters said recessed region, a funnel is located under the manifold and configured to direct fluid flowing from said manifold to said moisture sensor.

Optionally, the lower surface of the control unit is removably connected to the upper surface of said base unit. The control unit is in electrical communication with the base unit. The control unit is physically disconnected from the base unit. The control unit is able to exchange data with the base unit. The control unit is in fluid communication with the base unit.

In another embodiment, the present invention relates to a dialysis apparatus comprising a first block, said first block comprising a door having a first surface, a housing attached to said door, the housing having a second surface, at least one collector receiver, firmly attached to said second surface, and a display for displaying a graphical user interface, and a second unit, said second unit comprising a flat surface for supporting the container A liquid weighting means, integral with said planar surface, a heater in thermal communication with said planar surface, and sodium sensor near said flat surface.

Optionally, the collector receiver is configured to receive a molded plastic base that forms a first flow channel that is hydraulically isolated from the second flow channel. The molded plastic base comprises a first layer; second layer; a first flow channel formed by a first surface of the first layer and a first surface of the second layer; a second flow channel formed by a first surface of the first layer and a first surface of the second layer; and a valve in fluid communication with both of said first flow passage and said second flow passage, said valve having a first state and a second state, wherein being in said first state, the first flow passage and the second flow passage are in liquid isolation and, being in said second state, the first flow channel and the second flow channel are in fluid communication.

Optionally, the molded plastic base comprises a first plurality of ports in opposite alignment with a second plurality of ports. At least one of said first plurality of ports and a second plurality of ports comprises a component having an external cylindrical body, said component having an internal space defined by a central axis. The central axis is aligned with the plane in which said plastic base lies. The angle is from 5 degrees to 15 degrees. At least one of said first plurality of ports is defined by a cross-sectional area having a first diameter and a second diameter perpendicular to the first diameter. At least one of said first plurality of ports is connected to a port channel having a predetermined cross-sectional area having a third diameter and a fourth diameter perpendicular to the third diameter, the third diameter being larger than the first diameter, and the fourth diameter being smaller than the second diameter. The port channel contains at least one protruding part, the height of which is less than the fourth diameter. The port channel is closed by a flexible membrane. The port channel contains at least one protrusion that does not allow the flexible membrane to be drawn into said port channel and completely block said port channel. The cross-sectional area of said port channel is different from said cross-sectional area of said port, and the cross-sectional area of said port channel is configured to maintain a substantially constant fluid velocity passing through said port and into said port channel.

Optionally, the molded plastic is formed by a first segment, a second segment and a third segment; said first segment being parallel to said second segment; wherein said third segment is perpendicular and attached to each of said first segment and second segment; wherein said first, second, and third segments form a first flow channel that is hydraulically isolated from the second flow channel.

Optionally, the first segment has a first plurality of ports, and said second segment has a second plurality of ports, said first and second plurality of ports being aligned with each other.

At least one of said first plurality of ports and a second plurality of ports comprises a part having an internal space defined by a central axis. The central axis is aligned with the plane in which the said first and second segments lie. The angle is from 5 degrees to 15 degrees. At least one of said first plurality of ports is defined by a cross-sectional area having a first diameter parallel to the length of the first segment and a second diameter perpendicular to the first diameter. At least one of said first plurality of ports is connected to a port channel having a cross-sectional area with a third diameter parallel to the length of the first segment and a fourth diameter perpendicular to the third diameter, the third diameter being larger than the first diameter, and the fourth diameter being smaller than the second diameter. The port channel contains at least one protruding part, the height of which is less than the fourth diameter. The port channel is closed by a flexible membrane. The port channel contains at least one protrusion that does not allow the flexible membrane to be drawn into said port channel. The cross-sectional area of said port channel is different from said cross-sectional area of said port, and the cross-sectional area of said port channel is configured to maintain a substantially constant Reynolds number of fluid passing through said port and into said 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 second segment. The first segment has at least one port, wherein a portion of the inner surface of said port is formed by a flat base. The first segment and said second segment have a length in the range of 4 to 7 inches and a width in the range of 0.5 to 1.5 inches. The third segment has a length ranging from 2.5 to 4.5 inches. The first segment has a first length and a first width, said second segment has a second length and a second width, and said third segment has a third length and a third width, said first length and said second length being greater than a third width, and said first width and second width being less third length. The first segment has a first length and a first width, and said second segment has a second length and a second width, said first length being equal to said second length, and said first width being equal to said second width.

Optionally, the collector receiver is configured to receive a molded plastic base, the tubular segment connecting said molded plastic base with a dialyzer. The dialysis apparatus comprises a receiver for attachment with the possibility of removing said dialyzer to the outer surface of said dialysis apparatus. The tubular segment comprises a disposable conductivity probe having an internal volume, said internal volume receiving a fluid flowing through said tubular segment. The disposable conductivity probe is removably connected to docking probes located on the outer surface of the dialysis apparatus.

In another embodiment, the present invention relates to a dialysis apparatus comprising a first unit capable of communicating with a second unit, said first unit comprising a door with a pressure plate located on an inner surface of the door, a cabinet with a panel, said cabinet and panel forming a recessed an area configured to receive said inner surface of said door, an alignment mechanism firmly attached to said panel, said alignment the coupling mechanism is configured to detach the collector on said panel and position said collector opposite said pressure plate when the door enters said recessed region, said second block comprising a flat surface for receiving a liquid container, a weighing means combined with said flat surface, a heater in thermal communication with said flat surface; and a sodium sensor in the vicinity of said flat surface.

In another embodiment, the present invention relates to a multi-pass sorbent hemodiafiltration system, advantageously combining hemofiltration and hemodialysis in a multi-pass configuration.

In another embodiment, the present invention relates to collector supports for blood purification systems, for example, but without limitation, hemodiafiltration and ultrafiltration. In one embodiment, the collector of the present invention comprises a composite plastic collector in which flow channels for blood and dialysate are formed. This plastic collector can be used with the multi-pass sorbent hemodiafiltration system of the present invention.

In another embodiment, components of a blood purification system, such as sensors, pumps, and consumables, are integrated into a molded manifold. Disposable items, for example, but without limitation, the dialyzer and sorbent cartridges, can be loaded with the possibility of disconnection in the collector or installed in fluid communication with it. Disposable items, for example, but without limitation, the dialyzer and sorbent cartridges, are firmly attached to the pipeline, which is firmly attached to the collector and is in fluid communication with it.

In yet another embodiment, an ultrafiltration system is integrated into the collector by molding in the manifold flow channels for blood and ultrafiltrates. In one embodiment, the manifolds disclosed herein comprise single composite plastic structures, also referred to as backings or bodies, which can be made by combining two plastic backing halves.

In another embodiment, the present invention relates to a dialysis system that supports an electronic locking system. Accordingly, in one embodiment, the reader is mounted on the housing (s) and / or collector (s) of the system, for example, but without limitation, hemodiafiltration and ultrafiltration collectors, and reads identifiers on disposable items that are loaded into the housing (a) and / or dialysis manifolds. The reader communicates with the database via a network, for example, a public network or a private network, to check the suitability, accuracy of disposable items or their integrity for safe and free use. This is done by requesting information about disposable items from a remote database, based on item identification pointers. If a disposable item has the status “unserviceable” or “doubtful” (based on information received from the database), the system “blocks” the use of the downloaded consumables and, thus, does not allow the user to continue using the system for treatment.

These and other embodiments are described in the "Detailed Description" section, where reference is made to the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention can be better understood by referring to the following detailed description, taken in connection with the accompanying drawings, in which:

Figure 1 is a front view of one embodiment of a dialysis system of the present invention;

FIG. 2 is a view of one embodiment of a dialysis system showing modularity of the system; FIG.

Figure 3 is a front view of one embodiment of a dialysis system with an open door;

Figure 4 is a top view of one embodiment of a portable dialysis system with the indicated approximate dimensions;

5 is a front view of one embodiment of a portable dialysis system with the indicated approximate dimensions;

6 is a front view of another embodiment of a dialysis system;

7 is a view of another embodiment of a dialysis system, demonstrating the modularity of the system;

Fig. 8 is a front view of another embodiment of a dialysis system;

9 is a top view of one embodiment of a reservoir unit of a dialysis system;

Figure 10 is a schematic view of exemplary components located on the upper surface of the reservoir block of the dialysis system;

11 is a schematic view of an exemplary accession component located on the upper surface of the reservoir block of the dialysis system;

12 is a schematic view of exemplary components located on the upper surface of the reservoir block of a dialysis system;

13 is a schematic view of exemplary components located on the lower surface of a control unit of a dialysis system;

Fig. 14 is a schematic view of an exemplary interaction component located on the upper surface of a reservoir unit of a dialysis system;

FIG. 15 is a schematic view of one embodiment of an inner frame of a control unit of a dialysis system; FIG.

Figa is a front / side view of one embodiment of a dialysis system of the present invention;

Figv is a front / side view of another embodiment of a dialysis system of the present invention;

Fig. 16C is a side view of another embodiment of a dialysis system of the present invention;

17A is a schematic view of an internal structure of one embodiment of a reservoir unit of a dialysis system of the present invention;

17B is a schematic view of an internal structure of one embodiment of a reservoir unit of a dialysis system of the present invention;

17C is a schematic view of an internal structure of one embodiment of a reservoir unit of a dialysis system of the present invention;

Fig.17D is a schematic diagram of an exemplary conductivity sensor;

FIG. 17E is a diagram of an example coil used in a conductivity sensor; FIG.

FIG. 18 is a schematic view of a bend sensor used in one embodiment of a reservoir unit of a dialysis system of the present invention; FIG.

Fig. 19 is a schematic view of a door locking mechanism implemented in one embodiment of a control unit of a dialysis system of the present invention;

FIG. 20 is a schematic view of a door locking mechanism implemented in one embodiment of a dialysis system control unit of the present invention; FIG.

21 is a front view of one embodiment of a dialysis system with an open door and a mounted collector;

FIG. 22 is a schematic view of one embodiment of moisture sensors located on a reservoir unit of a dialysis system; FIG.

FIG. 23 is an enlarged schematic view of one embodiment of moisture sensors located on a reservoir unit of a dialysis system; FIG.

24 is a front view of one embodiment of a reservoir unit of a dialysis system with an open door;

25 is a schematic view of one embodiment of a connector mechanism for attaching a sorbent cartridge and / or a concentrate vessel to a dialysis system;

26 is a first exemplary pipeline diagram;

Fig. 27 is a second exemplary pipeline diagram;

Fig. 28 is a third exemplary pipeline diagram;

Fig. 29 is a fourth exemplary pipeline diagram;

30 is a schematic view of one embodiment of an exemplary collector;

Fig. 31 is a schematic view of another embodiment of an exemplary collector;

Fig. 32 is a schematic view of another embodiment of an exemplary collector with dimensions;

Fig. 33 is a schematic view of another embodiment of an exemplary collector;

Fig. 34 is a diagram showing a first exemplary fluid flow through a port;

Fig. 35 is a diagram showing a second exemplary fluid flow through a port;

Fig. 36 is a diagram showing one embodiment of a design of an inclined collector port;

Fig. 37 is a diagram of one embodiment of a molded flow channel having a substantially flat base;

Fig. 38 is a fifth exemplary pipeline diagram;

Fig. 39 is a diagram of another embodiment of an exemplary collector used in connection with other dialysis components;

40 is a diagram of another embodiment of an exemplary collector;

Fig. 41 is a front view of one embodiment of a control unit for a dialysis system with an open door and a mounted collector;

Fig. 42 is a front view of one embodiment of a control unit of a dialysis system with an open door and an installed manifold using guides for attachment;

Fig. 43 is a circuit diagram depicting an exemplary photoacoustic flowmeter;

Fig. 44 shows a plurality of propagating signals generated by an exemplary photoacoustic flowmeter;

Fig. 45 is a circuit diagram showing an exemplary heat meter;

Fig. 46 shows a plurality of propagating signals generated by an exemplary heat meter;

Fig. 47 depicts a plurality of variables defining the operation of an exemplary heat meter;

Fig. 48 depicts a plurality of propagating signals generated by an exemplary heat meter;

Fig. 49 depicts a plurality of variables defining the operation of an exemplary heat meter;

Fig. 50A depicts a plurality of propagating signals generated by an exemplary heat meter;

Fig. 50B shows a plurality of propagating signals generated by an exemplary heat meter;

Fig. 51 shows a plurality of variables defining the operation of an exemplary heat meter;

Fig. 52 shows a plurality of variables defining the operation of an exemplary heat meter;

Fig. 53 is a diagram showing an exemplary heat meter;

Fig. 54 is a diagram showing an exemplary heat meter;

Fig. 55 shows a plurality of propagating signals generated by an exemplary heat meter;

Fig. 56 is a front view of one embodiment of a control unit of a dialysis system with an open door and a mounted collector;

Fig. 57 is a diagram of an example temperature sensor;

Fig. 58 is a diagram of an example disconnect monitoring system;

Fig. 59 is a diagram of an example disconnect monitor;

60 is a flowchart defining an exemplary disconnect detection process;

Fig. 61 is a diagram showing an exemplary placement of a catheter for CVP measurement;

62 is a diagram showing an exemplary dialysis system using CVP measurements;

63 is a diagram showing an exemplary catheter placement and CVP measurement;

Fig. 64 is a sixth exemplary pipeline diagram;

Fig - seventh approximate diagram of the pipeline;

Fig - eighth approximate diagram of the pipeline;

Fig. 67 is a table showing one embodiment of using a change of pumps to achieve volumetric accuracy;

Fig. 68 is a ninth example pipeline diagram;

Figa - tenth exemplary diagram of the pipeline;

Figv - the eleventh exemplary diagram of the pipeline;

Fig. 69C is a twelfth exemplary pipeline diagram;

70 is a thirteenth exemplary pipeline diagram;

Figa is a first schematic view of an exemplary system of magnetic valves;

Fig. 71B is a second schematic view of an example magnetic valve system;

Fig - schematic view of a component of an exemplary system of magnetic valves;

Fig is a schematic view of another exemplary system of magnetic valves;

Fig. 74 is a diagram depicting the operation of an example magnetic valve system;

Fig. 75 is a graph linking diaphragm displacement with force for an exemplary solenoid valve system;

Fig. 76 is a diagram depicting the operation of an example magnetic valve system;

Fig.77 is a flowchart depicting the operation of an exemplary system of magnetic valves;

78 is a diagram of an exemplary equipment architecture for one embodiment of a dialysis system;

Fig. 79 is a table showing one embodiment of a variety of additives for use in a dialysis system;

Fig. 80 is a flowchart depicting one embodiment of a process that allows users to accurately add additives;

Fig is a diagram showing a packaged disposable kit;

82 is a diagram showing one embodiment of a disposable kit comprising a manifold and a dialyzer connected to a plurality of tubes;

83 is a diagram showing one embodiment of an electronic interlock system integrated in consumables;

84 is a fourteenth exemplary pipeline diagram;

Fig - fifteenth exemplary diagram of the pipeline, showing the operating mode of refueling; and

Fig is a diagram of another variant implementation of an exemplary collector.

DETAILED DESCRIPTION

Although the present invention can be implemented in many different forms, in order to facilitate an understanding of the principles of the invention, we will consider the embodiments illustrated in the drawings, and a specific language will be used to describe them. However, it is obvious that this does not impose any limitation on the scope of the invention. Any changes and additional modifications are allowed in the described embodiments and any additional applications of the principles of the invention described here, which is obvious to a person skilled in the art to which the invention relates.

“Duration” and its variants refer to the period of the prescribed treatment, from the beginning to the end, regardless of whether the treatment is completed due to the condition being fulfilled or the treatment is suspended for one reason or another. During the duration of treatment, many treatment periods may be prescribed during which one or more prescribed stimuli are administered to the subject.

“Period” means the time during which the “dose” of stimulation is assigned to the subject as part of a prescribed treatment plan.

The term “and / or” means one or all of the listed elements or a combination of any two or more of the listed elements.

The terms “contains” and its variations are not intended to be limiting when these terms appear in the description and claims.

Unless otherwise indicated, “a”, “an”, “the”, “one or more”, and “at least one” are used interchangeably and mean one or more than one.

For any method disclosed herein that includes discrete steps, the steps may be carried out in any feasible order. And, if necessary, you can simultaneously carry out any combination of two or more stages.

Also in this description, the indication of numerical ranges by endpoints includes all numbers belonging to this range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5 , etc.). Unless otherwise indicated, all numbers expressing the amounts of components, molecular weights, etc. used in the description of the invention and the claims should be considered as supplemented in all cases by the term “about”. Accordingly, unless otherwise indicated, the numerical parameters given in the description of the invention and the claims are approximations that may vary depending on the properties that it is desirable to obtain through the present invention. At the very least, and not in an attempt to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should be considered, at least in light of the number of reported significant digits and by applying conventional rounding methods.

Although the numerical ranges and parameters defining the wide scope of the invention are approximations, the numerical values set forth in specific examples are reported as accurately as possible. However, all numerical values internally contain a range that inevitably results from the standard deviation found in their respective test measurements.

Device design

In the present description of the invention, embodiments of dialysis systems that are modular and portable with enhanced safety and functionality are disclosed. 1 and 2, in one embodiment, the dialysis system 100, 200 comprises an upper unit 101, 201 which is detachably connected to the base 102, 202. The base 102, 202 comprises a reservoir 122, 222 for storing, measuring and monitoring the liquid. The upper unit 101, 201, also referred to as the main unit or control unit, contains a graphical user interface 114, 214, a pump unit and a door 110, 210 with an electric lock and a redundant mechanical mechanism, which is further discussed below.

On the first side of the upper block 101, 201, a carabiner 105 is used to disconnect the dialyzer 103. On the second, opposite side of the upper block 101, 201, a locking base 104, 204 of the sorbent cartridge is used to disconnect the sorbent cartridge 107. Obviously, the carabiner 105, the hemofilter 103, 315, the locking base 104, 318 of the sorbent cartridge and the cartridge 107, 317 of the sorbent can be located on the same side of the upper block 101, as shown in FIG. 3. In any case, the lower block has a sufficiently large area than the upper block, so that shelves are formed on both sides of the upper block to hold the sorbent cartridge, to hold the vessel with the infusate, to capture any leakage and / or to direct any leakage to the leak detector.

Anticoagulant deposits in the form of syringe pumps 190 are provided between the dialyzer 103 and the door 110. Optionally, the upper block 101 may include a bottle holder having a narrowed base for receiving the bottle, from top to bottom, in the bottle holder body. The infusion lines are connected to the inlet of the blood pump, the outlet of the blood pump or the output of the dialyzer (blood side). Infusion lines can also 'pass' through air bubble detectors to determine if the anticoagulant has run out or is blocked.

In one embodiment, according to FIG. 4, the top unit 401, which contains the user interface and the controller, has the same depth as the base unit 402, which contains the tank combined with the scales, but other lengths and heights. In this exemplary embodiment, the upper block 401 and the lower block 402 have a depth D ranging from 10 to 30 inches, more preferably about 19 inches. As shown in FIGS. 4 and 5, in this exemplary embodiment, the upper block 401, 501 has an Lt length in the range of 6 to 20 inches, more preferably approximately 14 inches, and the lower block 402, 502 has an Lb length in the range of 14 to 40 inches, more preferably 27 inches. In this exemplary embodiment, the upper block 401, 501 has a height Ht ranging from 7 to 21 inches, more preferably about 14.5 inches, and the lower block 402, 502 has a height Hb ranging from 3 to 11 inches, more preferably , 7 inches.

As shown in FIG. 5, the base unit 402, 502 can be further formed by two steps 504, each extending outward, along the length of the base unit 502, from the sides of the centrally located upper unit 501. The upper unit is preferably located in the center of the base unit 502 , which is measured by the length Lb in FIG. 4. Accordingly, the step 504 can be defined as having a length ranging from 4 inches to 10 inches, more preferably about 7 inches. Upward from the surface of the base unit 502, where the steps 504 are physically joined with the upper unit 501, a lip 503 extends, which forms the surface on which the upper unit 501 is aligned and located. The lip 503 adjoins the base of the upper unit 501, having the same length and depth, as the upper block 501, the height being set as the difference between Ht2 and Ht. In one embodiment, the height of the lip is from 0.1 to 3.5 inches, more preferably 0.6 inches. The total height of the system, Ht3, is from 10 to 35 inches, more preferably 22 inches.

The structures of the outer casing, forming the upper block 501 and the base block 502, can be characterized as rectangular parallelepipeds, cuboids or boxes, each of which has four lateral, upper and lower faces. In an exemplary embodiment, for both the upper block 501 and the base unit 502, two of the four sides, each of which has an outer surface and an inner surface, have the same height, length and depth, while the upper and lower structures, each of which has an outer surface and an inner surface, have the same height, length and depth.

Obviously, the system configurations shown in FIGS. 1, 2, 3, 4 and 5 are exemplary and non-limiting. For example, FIG. 3 shows that the top block 301 may be located on one side of the base unit 302 (creating an asymmetric base), or may be located in the center on top of the base unit 302 relative to the full length of the base unit 302 (creating a symmetrical base). Although the placement of the upper block 301 on one side of the base unit 302 has the advantage of placing all piping connections and consumables on the same side of the system, the sorbent cartridge 317 and the dialyzer 313 unnecessarily come close to each other, which makes it difficult to use the apparatus.

6, in another embodiment, the upper block 601, which contains the user interface and the controller, has the same depth and length as the base block 602, which contains a tank combined with scales 604, but a different height. In this exemplary embodiment, the upper block 601 and the lower block 602 have a depth ranging from 16.0 to 20.0 inches, more preferably less than 24 inches and about 17.0 inches. In this exemplary embodiment, the upper block 601 and the lower block 602 have a length Lt ranging from 10.0 to 15.0 inches, more preferably less than 18 inches or about 13.0 inches. In this exemplary embodiment, the upper block 601 has a height Ht ranging from 10.0 to 14.0 inches, more preferably less than 17 inches and about 12.0 inches, while the lower block 602 has a height Hb ranging from 9, 0 to 11.0 inches, more preferably less than 13 inches and approximately 9.5 inches. The total height of both blocks together is designated Ht3. The base unit 602 and the upper unit 601, thus, have the same base area, but different heights. Obviously, the base unit 602 and the upper unit 601 may have the same base area and also the same height.

From under the base unit 602 pass flattened transverse wings 610, which contain connectors for attaching the sorbent cartridge and the container 615 infusate. The surface of the transverse wings 610 may include a membrane that can electronically detect the presence of moisture and / or can be tilted to direct any moisture to strategically located sensors.

7, in another embodiment, the upper unit 701 can physically interact with a docking station 705, which electronically and hydraulically interacts 715 with a remotely located base unit 702. Although the reservoir located in the base unit 702 should still be in fluid communication with the controller 701, the use of the docking station 705 will provide increased flexibility in switching off the size of the used tank system, thereby allowing the implementation of a single controller design in multiple scenarios using use or for a wider range of patients, for example, from small to large patients.

Referring to FIG. 8, in yet another embodiment, the portable dialysis system 800 includes an upper subsystem (pressure and control unit) 801, as described previously, with a lower assembly 802. The lower portion 802 of the system 800 includes an independent, dialysate pendant 805. Thus, dialysate bag 805 is not part of the bottom assembly 802, as in the previously disclosed embodiments. Additionally, the lower assembly 802 is designed so that it includes a weighing mechanism, built into the structure 810, which suspend independent dialysate packages 805. This configuration is suitable when the dialysis system is configured to operate in hemofiltration mode because, in hemofiltration mode, various sensors used in sorbent dialysis, for example, ammonia, pH and sodium sensors, are not required; thus, the entire reservoir assembly module can be removed, and system 800 can simply be operated using dialysate bag 805. The modular and compact design of the lower 802 subsystem simplifies its removal and simplifies the operation of the system in hemofiltration mode by eliminating unnecessary components. This is another advantage of integrating the main dialysate components used in hemodialysis into the lower base unit 802.

The dialysis system of the present invention achieves functional and operating parameters that represent a significant improvement over the prior art. According to the embodiments shown in FIGS. 1-6, the upper block weighs about 20-40 pounds, and in a more particular case 30 pounds, and the lower block weighs about 15-30 pounds, and in a more particular case 22 pounds, thus smaller than traditional systems. The volume of the upper block is approximately 1 to 4 cubic feet, and in a more particular case, 2.3 cubic feet, and the volume of the lower block is approximately 1 to 4 cubic feet, and in a more particular case, 2.8 cubic feet, i.e. less than the volume of traditional systems.

In addition, the dialysis system uses less water than traditional systems. While traditional systems use about 120 liters per treatment session, in one embodiment, the present system uses from 3 to 8 liters, and in a more particular case from 5 to 6 liters. In addition, the system does not require a sewer, water supply or a separate outlet to drain excess water.

Additionally, the design of the system is more compact, has low power consumption (only 300 watts in peak mode and from 50 to 100 watts during operation), does not feel the need for any separate packages of liquid for refueling or moving, and contains built-in pumps. The device operates using a blood flow range of 20-600 Qb (ml / min), a dialysate flow of 50-500 Qd (ml / min). The volume error is also less than ± 30 ml / h.

As shown in FIG. 2, the dialysis system is modular. In one embodiment, the upper block 201 may be physically separated from the lower block 202. The upper block 201 comprises primary electronic systems, including a graphical user interface, controllers and pumps, enclosed in a closed enclosure. The larger, bulkier lower unit 202 comprises a reservoir 222. Separating the electronic systems from the reservoir allows the portable dialysis system to be divided into multiple units for installation, maintenance and movement, each subunit being easily maintained, packaged and carried. The design provides for specific component sizes for door-to-door transportation via UPS or other carriers. This additionally provides flexibility in ramping up production. For example, if improvements are made with respect to the control unit or, separately, the tank (for example, reducing the volume of liquid or changing the measurement of volumetric weights), the existing consumer needs to update only one of the two components, and not both. Similarly, if only one of the two components fails (for example, the pump burns out), the consumer only needs to send it for repair or purchase one of the two components.

To provide the modularity described above, embodiments of the present invention employ a locking mechanism that, in a first configuration, reliably attaches the lower unit 202 to the upper unit 201 and allows manipulation to disconnect, with the possibility of removing the lower unit 202 from the upper unit 201. Although the two systems can simply be stacked one to the other, without a latch, the presence and use of a latch reduces the likelihood of accidental disconnection. In addition, in the latched state, the device is easier to move. The latch mechanism preferably does not use any tools and is simply provided using pin-recessed docking connections present on the base of the upper block and the upper surface of the lower block. More preferably, the latch mechanism is designed to ensure consistent alignment between the upper and lower blocks, which allows the use of electronic components (for example, open electronic connectors on the lower surface of the upper block and the upper surface of the lower block, which is further described below), which, when the blocks are correctly aligned automatically come into contact and close the power circuit. This allows the use of a single power supply and simple connection / disconnection.

9, the lower block 902 has four sides 905a, 905b, 905c, 905d, a base, an upper surface 906, and a reservoir 922 accessible through the first side 905d. The lower block 902 further comprises a plurality of locking docking structures 920a, 920b on its upper surface 906. In one embodiment, the present invention comprises two locking docking structures 920a, 920b that are centrally positioned relative to the length of the lower block 902 to ensure uniform weight distribution. The first locking docking structure 920a is preferably located at a distance equal to one third of the width of the lower block 902, which is measured from the side 905d. The second locking docking structure 920b is preferably located at a distance equal to a third of the width of the lower block 902, which is measured from the side 905b.

The locking mechanisms, as shown in FIG. 10, comprise a metal frame 1001, which makes it possible to securely fasten them using, for example, a bolt, screw or other fastener 1002 to the upper surface of the lower unit 1005. The frame 1001 supports a protrusion or an elongated part 1003, which can be flexibly inserted into and removed from the corresponding latch.

For reliable and removable attachment of the lower block to the upper block, the upper block contains additional mechanical sliding latches that are securely attached to the base of the upper block. In one embodiment, the base of the upper block comprises a first latch, which is preferably located in the center of the upper block, relative to the length of the upper block, and at a distance equal to a third of the width of the upper block, which is measured from the first side. The base also contains a second latch, which is preferably located in the center of the upper block, relative to the length of the upper block, and at a distance equal to a third of the width of the upper block, which is measured from the second side, which is opposite and parallel to the first side.

As shown in FIG. 11, the upper block comprises a latch 1100 with a sliding metal flat base 1120. The rails 1130 are slidingly mated to the bottom surface of the upper block, which has mating parts to hold the rails 1130 in place. The latch 1100 has two locking strips 1115, made with the possibility of sliding into and out of the docking structure, physically attached to the upper surface of the base unit.

The latches 1100 attached to the upper block are joined with the locking docking structures 920a, 920b on the upper surface of the lower block 906. From an operational point of view, when the sliding latch 1100 is in the first position, the upper block will not effectively adjoin the upper part or align with the base block, since the sliding latch 1100 will not physically fit properly with the locking docking structures 920a, 920b. To prepare the upper block for reliable placement on the upper surface of the base unit 906, the sliding latches are moved in the structure holding the part located on the lower surface of the upper block and are placed in the second position. In the second position, the latch handle 1111 will protrude, thereby moving the strips 1115 away from the locking dock structures 920a, 920b and allowing the upper unit to correctly sit on the base unit.

12 and 13, the upper block 1301, which has sliding latches 1380, is aligned with the lower block 1202 with four small rubber feet or bottom pads 1340 on the lower surface of the upper block 1301, which are configured or configured to fit tightly and securely into the four cavities or pockets 1230 located at the corners on the upper surface of the lower block 1202. Additionally, the upper block 1301 can be precisely aligned with the lower block 1202 using alignment pins 1260 or protrusions on the upper surface of the base unit 1202, which are configured or configured to fit securely and tightly into corresponding cavities 1390 on the lower surface of upper unit 1301. The lower unit also has locking docking structures 1263, as described above.

The contact of the rubber feet 1340 in the cavity 1230 and the pins 1260 in the cavity 1390 ensures that the latches 1380 on the upper block 1301 can easily be aligned and engage with the locking docking structures 1263 without unnecessary trial and error. When aligned, the latch 1380 fits into the locking docking structures 1263 by sliding the latches 1380 into the locking docking structures 1263, thereby providing a snug fit between the two blocks. Returning to Figs. 9 and 11, for disengagement, the latch arms 1111 are pulled out or otherwise manipulated, which releases the slats 1115 from the slots 920a, 920b of the base unit and allows the upper unit to be lifted above the lower unit.

In addition, to ensure the above modularity, embodiments of the present invention also apply an electrical and communication connection mechanism, which, in the first configuration, reliably establishes an electrical connection and / or data connection between the lower unit and the upper unit, and, in the second configuration, breaks the electrical connection and / or connection with the possibility of data transfer between the lower block and the upper block.

According to FIG. 14, electrical connections between the upper and lower blocks are created when the upper block is located on the lower block. These connections are established through the non-contact infrared communication port 1403 and the push-pin power port 1404, which are formed together with the plates 1402 and are securely connected using fasteners 1401 to the upper surface of the lower block 1405. Obviously, the lower surface of the upper block will contain, in correct alignment with the pressure pins, the pad of electrical contacts. It is also obvious that the pressure pins and contact pads can be interchanged, thus placing the pressure pins on the lower surface of the upper block, and the contact pads on the upper surface of the lower block.

In one embodiment, a high current power connection is created by bringing six spring-loaded pressure pins into electrical contact with pads that are embedded in the lower surface of the upper unit. Three push pins are for +24 VDC and three push pins are for grounding. In one embodiment, the pressure pins or probes have the following characteristics: a) a minimum center of 0.175 inches, b) a rated current of 15 A (constant), c) a spring force ranging from 6.2 oz to 9.0 oz when moving from 0 , 06 inches to 0.067 inches, d) typical resistance less than 10 mOhm, e) maximum movement in the range from 0.09 to 0.1 inches, f) working movement in the range from 0.06 to 0.067 inches, g) barrel made nickel / silver and gold-plated, h) stainless steel spring (optional, gold-plated), i) a plunger made of completely zakaz a beryllium-copper alloy and gold-plated, and j) optionally, a stainless steel displacement ball. The spring force of the pressure pins helps prevent breakage by absorbing bending or other deformations. Obviously, the term “electrical pins” represents any protrusion capable of transmitting electrical power, and “electrical contact pad” represents any surface capable of receiving an electric push pin.

The non-contact infrared communication port 1403 uses two LED transmitters and two LED receivers, which are aligned and communicate with two LED transmitters and two LED receivers on the lower surface of the upper unit. The distance between the transmit and receive ports is less than 0.3 inches. On the upper surface of the lower block and on the lower surface of the upper block, four LED blocks are divided into two pairs, a control pair (containing one transmitter and one receiver) and a protective pair (containing one transmitter and one receiver). These ports allow data to be transmitted when the upper and lower blocks are correctly aligned.

In one embodiment, the LED transmitters are 870 nm high-speed infrared LEDs made of GaAlAs using double heterojunction technology. LED transmitters are high-speed diodes with the following characteristics: a) ultra-high radiation power, b) low forward voltage, c) suitability for operation with large pulsed currents, d) half-angle angle of approximately 17 degrees, e) peak wavelength of approximately 870 nm, f) reverse voltage approximately 5 V, g) forward current approximately 100 mA, h) peak forward current approximately 200 mA, i) surge forward current approximately 0.8 A, j) dissipated power approximately 190 mW, k) temperature Passing about 100 degrees Celsius, and l) the working temperature range of -40 to 85 degrees Celsius. It is obvious that non-contact infrared communication ports can be distributed in any functional way along the upper surface of the lower block or the lower surface of the upper block. It is also obvious that here you can implement any other communication port or design known to specialists in this field of technology.

In one embodiment, the LED receivers are high speed silicon photodiodes with very short response times, an emissivity area of approximately 0.25 mm ² and a half sensitivity angle of approximately 15 degrees. The receivers have the following characteristics: a) a reverse voltage of approximately 60 V, b) a power dissipation of approximately 75 mW, c) a transition temperature of approximately 100 degrees Celsius, d) an operating temperature range of -40 to 85 degrees Celsius, e) a forward voltage of approximately 1 V f) a minimum breakdown voltage of 60 V, and g) a diode capacitance of approximately 1.8 pF.

Returning to Figs. 1, 2 and 3, on top of the control unit 201 are the handles 211, 311 and the working area in the form of a shelf 112, 212, suitable for operation. The handles located on the upper pumping section of the system are directly connected to the internal structure or frame of the system, and are not just a continuation of the external plastic molding, body or shells surrounding the upper block 101, 201. Direct connection with the internal frame of the system allows you to use the handle to change position the system safely and reliably handle the load, in particular when the instrument is operated with six liters of water (which adds approximately 40 pounds).

According to FIG. 15, in one embodiment, the upper block 1501 comprises an inner metal housing, frame or chassis 1510, in which, and to which, electronics, a controller, and other components of the upper block are contained. The inner housing 1510 includes a horizontal protruding bracket 1507 that extends to the rear side of the upper block 1501. The substantially horizontal upper shelf 1505 includes at least one handle 1520, thus formed together with the upper shelf structure 1505, a base holder 1530 and vertical bracket 1506, thus creating a single, integral part of metal or molded plastic. The base holder 1530 is securely attached to the inner case 1510 on the front side of the upper block 1501, and the vertical bracket 1506 is securely attached to the protruding bracket 1507 at a point 1508 using screws. By reliably attaching the design of the shelf 1505 and the handle 1520 to the inner case 1510 of the upper block 1501, the potential damage or breakage that usually occurs due to placing large weight loads at the connection point between the handle and the outer or outer case of the upper block can be avoided.

Also, a metal door 1562, which forms the inner frame of the door 110 shown in FIG. 1, is hinged 1565 to the inner frame or housing 1510. Door 1562 is securely attached to plate 1561, which forms part of inner frame 1510. Structures 1563 and 1572 are structures that hold and / or represent protrusions, internal motors, and pulley assemblies. The protrusion 1583, which extends from the rear of the frame 1510, is used to connect various electronic components, including the power supply module and USB connections 1582. The upper part of the control unit, or shelf 1505, is flat and has side walls, which makes it ideal to protect stocks or temporary work surface.

Another structural feature of the control unit 1601 is shown in FIG. 16A. Preferably, block 1601 has a built-in open reader, such as a barcode reader or RFID reader 1605, which can be used to read codes or labels on disposable components. From an operational point of view, the user will preferably scan all codes / tags on disposable components with a reader. The user can be instructed during the initial installation of the GUI dialysis, which instructs the user to scan each disposable component with a reader.

After that, the reader receives identifying information about the disposable component, transmits this identifying information to the internal table stored in memory, compares the identifying information with the contents of the internal table, and checks (or does not verify) the presence of the correct disposable components (in particular, additives used in dialysate). The contents of the internal table can be generated by manually entering the identity and quantity of consumables or through remote access to a recipe that details the identity and quantity of consumables. This verification step has at least two advantages. The first allows you to make sure that the user has at his disposal all the necessary components, and the second allows you to make sure that the correct components are used (and not counterfeit or unsuitable supplies). This component can be used to provide various user interfaces, which is further described below.

In another embodiment, the reader 1605, mounted on the top of the unit, is a specialized multifunction infrared camera that, in one mode, provides the ability to read bar codes and, in another mode, registers the level change in the infusate container. The camera emits an infrared signal, which is reflected from the liquid level. The reflected signal is received by the infrared receiver of the camera and processed using a processor to determine the position of the meniscus of the liquid level. In one embodiment, the camera can detect and control the change in liquid level with a resolution of 0.02 mm. In one embodiment, the camera is a 1.3 megapixel single-chip camera module with one or more of the following characteristics: a) 1280 in width × 1024 in height of active pixels, b) pixel size 3.0 μm, c) optical format 1/3 inches, d) RGB Bayer color filter matrix, e) integrated 10-bit ADC, f) integrated digital image processing functions, including defect correction, lens shading correction, image scaling, demosaicing, sharpening, gamma correction and color conversion g) built-in camera controller for automatic exposure control, automatic white balance adjustment and black level compensation, h) programmable frame rate and output reduction functions, i) SXGA progressive scan up to 15 fps, j) VGA30 low-power progressive scan fps, k) 8-bit parallel video interface, l) two-wire serial control interface, m) intra-crystalline PLL, n) analog power supply from 2.4 to 3.0 V, o) separate power supply I / O, p) integrators nny power regulator with a power switch, and q) 24-pediculo shielded panel option. In one embodiment, the camera is a 1.3 megapixel camera manufactured by ST Microelectronics, Model No. VL6624 / VS6624.

The upper or lower unit of the dialysis system also preferably has electronic interfaces, such as Ethernet connections or USB ports, to provide a direct connection to the network, thus facilitating remote recipe checking, reconciliation control and other remote maintenance operations. USB ports allow direct connection with auxiliary products, such as blood pressure monitoring devices or hematocrit / saturation monitoring devices. Interfaces are electronically isolated, which ensures patient safety regardless of the quality of the paired device.

The front of the top unit has a graphical user interface 114, which provides a simple user interface with the system 100. In a home installation, it is important that the device can be easily used. The maximum use of colors and the touch screen are ideally suited for use. The touch screen allows for multiple user input configurations, provides multilingual capabilities and is clearly visible at night (in particular, thanks to brightness controls and night vision colors).

The GUI additionally includes a feature for automatically closing, opening and locking the door during operation. In one embodiment, the GUI opens the door to the first latch position, after which the user must press the physical door open button to fully open the door. In another embodiment, the device has a manual override that allows the user to open the door (for example, by double-clicking the door open button or by applying additional force) to manually open the door. According to FIG. 16A, preferably, near the GUI 1630, there is a single mechanical button 1610, with an illuminated visual indication, which, if activated, provides the central stop button with a common function (for example, stopping the system) regardless of the operation status.

To provide additional protection and safety, system 1600 controls the opening of the tank door 1625 in the base unit 1615 without the need for a door controller, button, or mechanical system, thus independent of the door control system of the upper unit 1601. In one embodiment, opening the tank door 1625 physically blocked by a protrusion 1620, which is physically connected to, connected to, or otherwise controlled by the front door 1635 of the upper block 1601. The protrusion 1620, which can pass through the door 1625 of the tank with Any direction relative to the upper block 1601, serves to provide a physical barrier to opening the door 1625 of the tank. Thus, in this embodiment, it is not possible to open the tank door 1625 without first unlocking and opening the controller door 1635, which is controlled by the user interface.

In another form of one embodiment of the dialysis system shown in FIG. 16B, the dialysis system 1600 comprises a control unit 1601 with an ammonia sensor 1670, an ISU 1630 and a single mechanical button 1610 for opening and closing the controller door 1635, and a base unit 1615 with a tank door 1625 the opening of which is physically blocked by the protrusion 1620, which is physically connected to, connected to, or otherwise controlled by the front door 1635 of the upper block 1601, and a built-in open reading device, for example, a barcode reader a 1605 device or RFID reader. The control unit 1601 and the base unit 1615 are located on top of a single continuous, substantially flat base or divided flat base 1645, which has two attachment mechanisms 1675, 1695. The first attachment mechanism 1675, which is used to hold the sorbent cartridge 1680 in place, is adjacent to the second attachment mechanism 1695, which is used to hold the concentrate vessel 1695 in place, on the same side of the dialysis system 1600. A flat base 1645, preferably contains a drip tray or other water-retaining or moisture-sensitive surface.

In FIG. 16C, the control unit 1601 and the base unit 1615 are shown sideways. The sorbent cartridge 1680 is held in place by the attachment mechanism 1675, and the concentrate vessel 1690 is held in place by the attachment mechanism 1695. The sorbent cartridge 1680 and the concentrate vessel 1690 are located on top of a flat surface, such as a drip tray 1668, to capture all moisture. The scanner 1605 is located on the side of the base unit 1615 and in direct optical communication with the vessel 1690 with concentrate. Liquids flow from the 1600 V system and from the sorbent cartridge 1680 and from the concentrate vessel 1690 through three tubular or flow segments 1641, 1642, 1643. The tubular segment 1642 provides fluid communication between the 1690 vessel and the concentrate with the collector through the collector concentrate port. The tubular segment 1641 provides fluid communication between the sorbent cartridge 1680 and the collector through the sorbent outflow port, thereby sending dialysate requiring regeneration to the sorbent cartridge 1680. The tubular segment 1643 provides fluid communication between the sorbent cartridge 1680 and the collector through the sorbent influx port, thereby receiving the regenerated dialysate from the sorbent cartridge 1680. The tubular segment 1643 is removably connected near the ammonia sensor 1670 using mechanisms 1671 such as hooks, clamps, clamps or other means to easily remove and position the tubular segment 1643 in close contact with the ammonia sensor 1670 located on the side of the control unit 1601 on the same side as the 1680 sorbent cartridge. In one embodiment, the ammonia sensor 1670 comprises an optical sensor that uses a colorimetric measurement approach to determine the presence of ammonia and whether such ammonia exceeds a predetermined threshold.

1, the reservoir system 102 has a door 118 that, when extended and not blocked by any protrusion, extends the reservoir 122 or otherwise makes the reservoir 122 accessible to the user so that the user can insert or change fluids used for dialysis. The volume of the tank is controlled by a weighing system. The liquid scale scales 604 depicted in FIG. 6 and, in a more particular case, FIGS. 17A and 17B are formed together with a reservoir and provide accurate fluid removal data and allow accurate balance calculations to be made, which prevents the development of hypotension and other painful conditions, caused by imbalance of liquids. The combination of the scales with the tank and their complete enclosure provides increased stability of the system.

On figa shows the internal structure 1700 of the reservoir system. The metal inner frame 1720 comprises two sides 1721, a rear part 1722, an open front part 1723, and a base 1724. The internal structure or frame is shown without an outer case, which is shown as element 102 in FIG. 1. Scales 1718 are integrated into the internal structure 1700 of the tank. The lower surface 1715 of the balance 1718 contains a metal surface or pallet, which, together with the remaining parts of the balance 1718, is suspended on the outer tank body (shown as 102 in FIG. 1) by four bend sensors 1705. Under the bottom surface 1715 of the balance, there is preferably a heating panel, for example a square, rectangular, round or other shape, a surface capable of causing an increase in temperature and conducting an elevated temperature, in the form of heat, to the surface 1715. A conductivity coil 1770 capable of creating a field and using changes of this field for measuring conductivity, is embedded in the surface of the base 1715. Accordingly, when a reservoir package (not shown) is located on the bottom surface 1715, it can be heated by a heating panel and, since it contacts the coil 1770, its conductivity can be controlled.

The inner surfaces of the sides 1721 comprise a plurality of rails, elongated parts or protrusions 1719, which serve to fasten, hold, pack or attach to the mounting surface of the disposable reservoir package, for example, a plastic sheet 1710 to which the reservoir package can be attached. In particular, a reservoir package located on surface 1715 may have an outlet connected to a pipe 1771 embedded in sheet 1710. Bend sensors 1705 are installed at each of the four corners of surface 1718 of the balance, each of which contains a Hall sensor and a magnet.

Accordingly, in one embodiment, the components of the reservoir subsystem assembly include, but are not limited to, a dialysate reservoir including a disposable liner or reservoir pack, a dialysate heater, a dialysate temperature monitor, a tank weighing system including magnetic bend sensors and tilt sensor, ammonia concentration and dialysate pH sensor, including disposable sensor elements and a reusable optical reader, dialysate conductivity sensor (non-contact type), and moisture or leakage sensors.

It will be apparent to those skilled in the art that, in addition to the above sensors, other dialysate components, such as pumps and sensors, such as pressure transmitters, can also be included in the reservoir module. Additionally, various sensors, such as ammonia and pH sensors, can be integrated into the tank module as separate sensors or as a single 'sensor submodule' that contains all the sensors.

The inclusion of each of these components is carried out in such a way that the reservoir assembly module is especially suitable for use in a dialysis system with sorbent recirculation. Additionally, the module is also designed so that when performing other forms of dialysis, such as single-pass hemofiltration, you can remove any unnecessary elements of the module that are intended only for sorbent dialysis.

FIG. 17B illustrates one embodiment of a tank assembly module where outer shells or covers are made transparent, thereby opening up the internal configuration. An opening 1741 is provided in front of the reservoir subsystem module 1700. The primary function of the reservoir subassembly is to accommodate dialysate. Hole 1741 allows the insertion of a disposable bag of a reservoir, which may be a conventional bag for intravenous infusion with the dialysate contained therein. The reservoir module 1700 is also provided with a pallet 1742 inside the front opening to accommodate the tank package. In one embodiment, a flat film heater and a temperature sensor are located under the bottom of the tank pan 1742 and help maintain the temperature of the dialysis fluid at or near body temperature. In one embodiment, the temperature of the dialysis fluid may be set by the user.

In one embodiment, the tank pan 1742 is suspended in a scale mechanism 1743, which is further described below. The 1743 balance mechanism can be used to accurately measure the weight of the dialysis fluid in the reservoir bag prior to dialysis, and to maintain the volume balance of the dialysis fluid in the pipeline during dialysis.

On top of the reservoir assembly module 1700, features 1744 are provided for connection to the dialysis system pumping unit, as discussed previously. These features facilitate the attachment and removal of the reservoir assembly module from the pump unit, which in one embodiment may be mounted on top of the reservoir assembly. As further discussed below, the top of the tank assembly module is also equipped with gutters 1745 on both sides of the module. Separate moisture sensors (not shown) are provided in each of the grooves. As is known in the art, moisture sensors are optical devices that sense moisture based on the increased penetration of light into a liquid as opposed to air, due to the difference in the refractive index between air and liquid. Moisture sensors in the waste grooves 1745 monitor moisture and indicate any leaks in the pump system when it is installed on top of the tank assembly. Due to the presence of a separate moisture sensor in the drain groove on both sides, it is possible to determine the location of the leak and give the user a specific indication regarding any corrections that may be required.

FIG. 17C illustrates another view of a reservoir assembly module, where the outer covers of module 1700 are completely removed and some internal components are made transparent. 17C, the tank pan 1752 is provided with an internal groove 1753. The groove 1753 is further equipped with a moisture sensor, which is located directly below the dialysate pan 1752, to which bend sensors 1755 are connected, which allows leak detection within the tank assembly 1700.

The reservoir assembly module 1700 further comprises a sensor assembly 1754 or a submodule that comprises a plurality of different sensors on a single circuit board. The sensor board contains sensors, in particular those associated with sorbent dialysis, for example, ammonia and pH sensors. In one embodiment, the ammonia sensor comprises disposable color sensitive strips that are made of a material that exhibits a visible color change in accordance with the level of ammonia present in the dialysate. For example, the color of the indicator strip may gradually change from blue to yellow, depending on the level of ammonia present around the strip. This visual color indication makes it easy to track ammonia levels and detect ammonia breakthroughs. In one embodiment, an optical sensor is used to more accurately assess the color change in the strips of the ammonia indicator. An optical sensor is also located in the sensor module 1754 and can be used to convert the total visible color reading into an accurate indication of the ammonia level.

Regarding the concentration of sodium in the dialysate, it is obvious that in order to carry out the correct dialysis treatment of the kidneys and ensure proper diffusion through the dialyzer, the sodium concentration must be maintained in a certain range. The traditional way to determine the concentration of sodium in a liquid is to measure the electrical conductivity of the liquid and the temperature of the liquid, followed by the calculation of the approximate concentration of sodium. The improved method and system for measuring the concentration of sodium in the dialysate by the non-contact method uses a non-contact conductivity sensor built into the bottom of the pan 1752 of the tank.

In one embodiment, the non-contact conductivity sensor is an inductive device where a coil is used. A change in sodium concentration changes the conductivity of the dialysate, which in turn changes the impedance of the coil. By placing the conductivity sensor in the bottom of the pan 1752 of the tank and, thus, under the dialysate packet in the tank, a large surface area appears to the coil. This ensures high measurement accuracy, in addition to the absence of the need for physical contact of the sensor with the dialysis solution.

On Fig.17D and 17E shows the components of a non-contact electrical conductivity sensor, including a coil 1788 with n turns, generating a magnetic field when properly excited, and a circuit forming an LCR resonant circuit 1780, created when the coil formed by the resistive elements Rs 1786 and Rp 1785 and an inductive element L 1787, electrically connected to a capacitor 1781.

Coil 1788 is a multilayer, round, flat coil, used as an energy storage device in conjunction with a capacitor 1781. Coil 1788 has dissipative elements that contain the electrical resistance Rs 1786 of the wire of the coil and the dissipative element Rp 1785 of the magnetic field, the electrical conductivity of the liquid in the package.

The diameter of the coil 1788 is a function of the penetration of the magnetic field into the liquid. Another factor that penetrates the fluid is the operating frequency. A lower operating frequency will penetrate deeper into the liquid, but at the cost of lower losses. A larger coil will have a small effect due to size tolerances. The following is the driving equation:

where a = average coil radius in centimeters, N = number of turns, b = winding thickness in centimeters, h = winding height in centimeters. In one embodiment, the radius of the coil is from 2 to 6 inches and, in a more particular case, 2, 3, 4, 5, and 6 inches and all increments between them.

For circuit 1780, the physical coil 1788 is represented by L 1787 and Rs 1786, where L is the coil inductance and Rs is the electrical resistance of the coil wire. The loss of energy of the magnetic field generated by L 1787 is represented by Rp 1785. The loss of energy Rp arises from and is directly related to the conductivity of the liquid near the coil 1788. Thus, if the coil 1788 is located in the pan of the tank, it is built into the surface of the pan of the tank, or otherwise located on such the distance that the magnetic field generated by the coil 1788 may be affected by the presence of dialysate in the bag or, in a more particular case, the conductivity of the dialysate in the bag, changes in the concentration of sodium in the bag, and thus conductivity can be controlled and measured by tracking the corresponding changes in the magnetic field generated by the 1788 coil.

Circuit 1780 allows you to accurately measure changes in the magnetic field generated by coil 1788. When circuit 1780 is excited at its resonant frequency, energy is transferred back and forth between the inductive element L 1787 and capacitor 1781. In resonance, energy losses are proportional to the losses I ² R on R _S and R _P To maintain a constant AC voltage at C 1781, energy must be supplied to circuit 1780, and the supplied energy should be equal to the energy loss at R _P 1785 and R _S 1786. When the L 1787 and C 1781 elements form a Pierce generator with automatic gain control the voltage will be proportional to the recorded electrical conductivity of the liquid, since the generator will need more energy to oscillate with higher resistive field losses, mainly due to changes in dialysis conductivity This is due to changes in the concentration of sodium levels.

As mentioned previously with reference to FIG. 17B, the tank pan is suspended in the balance mechanism to accurately measure the weight and to maintain the volume balance of the dialysis fluid in the pipeline during dialysis. Suspension points 1755 for the weight mechanism are illustrated in FIG. 17C. In one embodiment, four suspension points 1755 are provided, each of which includes a weighing mechanism, as previously described. In addition to the four suspension points 1755, the reservoir assembly subsystem 1700 also includes a level sensor. The level sensor allows you to calculate the exact weight, even if the tank package is not horizontal. FIG. 17C also illustrates pins 1756 on top of the reservoir assembly module 1700, which can be used to provide electrical connectivity to a control and / or pump unit, which, as mentioned previously, can be mounted on top of the reservoir assembly.

18, the bend sensor 1805 comprises a plurality of attachment points 1861, where the bend sensor is attached to the outer tank body. The bend sensor further comprises magnetic bodies 1862, for example two magnets, and a Hall sensor 1864. The base 1867 of the bend sensor 1805 is attached to the upper surface 1715 of the balance 1718. When the balance 1718 is displaced due to the application of a weight load (for example, when the reservoir package is filled with dialysate, the package presses the surface 1715 and thus pulls the balance 1718 down), the bend sensor 1805, which is connected to the scales at one end and to the outer casing at the other end, will bend, and a magnet 1862 mounted on one end of the bend sensor 1805 will track this change due to changes in the magnetic field generated by the magnetic body 1862. Sensor 1864 to Hall registers changes in the magnetic field intensity. It will be apparent to those skilled in the art how to translate this recorded change in magnetic field to the extent of the applied weight load.

The front door opens wide (approximately 100 degrees) to load a disposable collector. The presence of a wide opening facilitates loading the collector and cleaning the surfaces of the apparatus and the inside of the door. A closed door that covers the moving parts of the device makes it safer and more stable, which is especially important for home use. Additionally, the presence of a display on the front door saves space and emphasizes the important point that the device should not be operated until consumables are in place and the door is closed. The door exerts the necessary blocking force on the manifold and its pump segments. The door also contains a touch screen warning sound alarm and a manual stop button on the door surface.

In one embodiment, the door is held fully closed by an electric stepper motor. This engine is driven through the user interface and, in particular, when the user presses a button when the door is ready to fully close or open. In order to ensure that the correct pressure is applied to the manifold structure by the door and pump pads, it is preferable to have an electronic mechanism by which the door is closed and a sufficient closing force of the door is generated. In one embodiment, a door closing force of 90 to 110 pounds is generated.

FIGS. 19 and 20 show one embodiment of a door closing power mechanism 1900. The stepper motor 1906 is mechanically coupled to the lead screw 1916, due to which, when activated by the controller, the stepper motor 1906 causes the lead screw 1916 to rotate, as a result of which the rod 1918, 2018 applies a driving force to the hook. The hook located under part 2040 serves to engage the horseshoe-shaped latch 2030 and, when pulling, turning, or otherwise moving inwardly to the stepper motor 1906, additionally tightening the horseshoe-shaped latch 2030 and, thus, applying the necessary closing force to the door. The hook is physically coupled to the rod 1918, 2018 and allows manipulation to tightly attract the horseshoe-shaped latch 2030 or to engage it gently with the horseshoe-shaped latch 2030. The force-closing system is installed and maintained in the correct orientation by the 1905 mounting brackets.

According to FIG. 21, during operation, the user closes the door sufficiently so that the horseshoe-shaped latch 2110 on the door engages with the hook 2150 inside the internal volume of the control unit. The user then indicates to the portable dialysis machine the desire to close the door, preferably with a mechanical button or pictogram of a graphical user interface, which, when pressed, sends a signal to the controller, which, in turn, activates the stepper motor. The stepper motor exerts a driving force on the hook 2150, which then tightly attracts the horseshoe-shaped latch 2110 associated with it. In one embodiment, the controller monitors the torque exerted by the motor and, when it reaches a predetermined limit, deactivates the stepper motor. In another embodiment, a Hall device located near the lead screw records the extension of the lead screw and determines the amount of movement of the screw. If the screw has moved enough in the direction of creating an increased force to close the door, the Hall sensor transmits a signal to the controller to deactivate the engine. Alternatively, the sensor continuously transmits a signal indicating the extension of the screw, which is then interpreted by the controller to determine if sufficient driving force has been applied and whether the stepper motor should be deactivated. In any of these embodiments, if the engine develops excess torque, a predetermined distance is exceeded, or the door does not reach its fully closed position at a predetermined time, the controller may instruct the engine to stop and begin to rotate in the opposite direction to enter the fully open state . The controller can also activate a visual and / or audible warning.

When the user wants to open the door, a mechanical button or pictogram of the graphical user interface is activated, sends a signal to the controller, which, in turn, instructs the stepper motor to rotate in the opposite direction. Then the hook engagement with the horseshoe-shaped latch weakens. The mechanical release button is then pressed to disengage the freely mated hook from the horseshoe-shaped latch.

In addition to providing the necessary closing force, this door closing power mechanism has several important features. Firstly, its design allows you to avoid getting into the door of obstacles and exposure to the closing force of the door with a power drive. 21, a region recessed into the door 2105 for receiving the manifold 2130 is surrounded by a four-sided edge protection 2107 that prevents the door latch from engaging with the latch receiver on the upper unit if an obstacle, such as a human finger or a mis-installed disposable component, is between door 2105 and the base plate of the upper unit. The door 2105 comprises an inner surface 2106 to which a metal housing 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 housing 2125. The housing 2125 is substantially rectangular and forms a cavity, four sides 2107 and a base 2108 which forms an internal volume. The cavity is open toward the collector structure 2130 of the dialysis system 2100 and surrounds and surrounds the collector structure 2130 and the protection 2140, which preferably is a plastic casing that surrounds the collector structure 2130 from above and sides. Pump pads 2115 and at least one horseshoe-shaped latch 2110 that protrudes to the back plate are connected to the surface of the base 2108. The hook 2150, combined with the guard and moving away from it, is configured for reliable engagement and disengagement with the horseshoe-shaped latch 2110. If the door is properly closed and nothing is caught between the door and the guard, the horseshoe-shaped latch is mechanically engaged by the locking mechanism of the power-operated door. If there is an obstacle in the way of moving the door, the metal case 2125 will not be able to enter the internal volume of the upper block (and embrace the protection), and thus the horseshoe-shaped latch will not be able to engage with the hook, which will prevent the mechanical engagement and accidental force closing of the door when the presence of obstacles.

Secondly, the mechanical release button can only be activated when the closing force of the power-driven door is dissipated by the reverse movement of the stepper motor, which prevents accidental release, and quick opening of the door. According to Figs. 19 and 20, when the door is closed and locked, the sleeve 2050 on the button axis 1907, 2007 rotates 90 degrees, pushing the pressure pin away from the locking hook of the power-operated door. The sleeve 2050 rotates under the action of the rod 1921, which is connected to the sleeve at a point 2045 and is in mechanical engagement with the lead screw 1916. The sleeve 2050 is spring loaded and is blocked by a small pin solenoid. If the user presses a button in a locked position, the button will move into the device, but, due to the displacement due to the rotation of the sleeve, it will not detach the hook, which prevents the door from opening.

In the event of a loss or inadvertent power failure, the pin solenoid is released, allowing the sleeve to rotate back 90 degrees and installing the pressure pin in the correct alignment. Then, when the user presses the button, the push pin contacts the hook of the power-operated door and releases the door latch. This mechanism provides the convenience and safe duplication of the mechanical release of the door without creating the problem that the mechanical release of the door can be accidentally activated, causing the door to open with very high force. Obviously, the term “hook” or “latch” should be understood in a broad sense as any protrusion or part that can physically or mechanically engage with another protrusion or part. It is also obvious that the term “horseshoe-shaped latch” is not restrictive, and any locking or engaging mechanism as defined above may be used.

As discussed above, the backup space formed by the lower block and surrounding the upper block uses drainage channels with fluid sensors in multiple positions inside and outside the device to provide zoned leak detection. In particular, due to the integration of drainage channels, with optical leakage sensors, into the external case of the device, the system captures and directs liquids potentially leaking from external components (for example, sorbent canisters) to optical leakage sensors. For example, in one embodiment, the surface of the upper block 2132 on which the manifold 2130 is mounted and on which the housing 2125 rests and forms a cavity, comprises inclined surfaces 2190 that form inclined edges for trapping moisture emitted or flowing from the manifold 2130, and areas around the collector 2130, and direct moisture, under the action of gravity, to the centrally located moisture sensor 2180. Preferably, the inclined surfaces 2190 are inclined sufficiently so that moisture settling on the inclined edges moves downward to one or more moisture sensors 2180 for receiving moisture. In one embodiment, one moisture sensor 2180 is located centrally relative to the position of collector 2130 and is equidistant from the ends of each inclined surface 2190.

In one embodiment, at least three different optical leak detectors are integrated in the outer shells of the lower unit. 22, the upper surface of the lower block 2202 is slightly inclined, with the center 2280 raised relative to the sides 2281 and 2282. In one embodiment, the surface is inclined downward from the central region 2280 to the sides 2281 and 2282, at an angle of 1 to 10 degrees preferably 3 degrees. Channels 2287 surround the upper surface of the lower block, pass along the perimeter, pass through the center of the upper surface, and / or pass through any other portion of the upper surface. Due to the inclined upper surface of the lower block 2202, the channels 2287 are also inclined from the center 2280 to the sides 2281, 2282. In another embodiment, the upper surface is also slightly inclined downward from the rear side 2291 to the front surface 2290. The inclination of the channels 2287 leads to liquids are directed from the center and / or rear of the system forward and to the sides where leak detectors 2288 are located, which are in fluid communication with channels 2287.

The first optical leak detector 2288 is located in the front right corner of the upper surface of the lower block 2202. The second optical leak detector 2288 is located in the front left corner of the upper surface of the lower block 2202. Each leak detector is located in the well or cavity and contains an optical sensor that is located on the side of the well . The optical sensor detects fluids that are drained and / or canalized into the wells, and transmits the registered signal to the controller in the upper unit. The registered signal is processed by the processor to determine if a leak has occurred. The registered signals are then stored and, if necessary, the processor instructs to display a warning signal or alarm on the GUI. The well or cavity preferably contains a rounded base, so that the user can easily wipe the well dry. On Fig shows a more detailed view of the upper surface of the lower block 2302 with channels 2387 and a leak detector 2388 located in the well 2397.

24, at least one additional leak detector is located in the lower block 2402 and, more particularly, inside the tank 2403, with which the scales 2404 are combined. Channels 2405 are built into the tank structure, for example, an inner case or a metal bag holder, and preferably inclined from one side to the other side or from the center to either side. In one embodiment, the angle is from 1 to 10 degrees and, in a more particular case, 3 degrees. The well 2410, where the leak detector is located, is integrated into the tank body and is in fluid communication with channels 2405 on one or both sides of the tank body. If a leak occurs in a disposable bag, fluid will drain to the corner of the metal pan or tank body through channels 2405 and be routed to at least one well with a leak sensor 2410.

The drainage channels have two functions: a) to ensure that no liquid enters the device, and b) to ensure that leakage is quickly suppressed and directed to a sensor that can trigger an alarm or warning. Additionally, the device preferably also includes channels for drainage of fluid leading into the wells with optical sensors on the inner surface of the device. So, for example, if there is a leak in the internal tank, liquid is drained from important components, and an optical sensor warns of a leak. Based on the activation of the sensor, the GUI can present a warning signal to the user and, in particular, can identify the position of the fluid leak. By providing several independent leak detection zones (multiple fluid sensors and drainage channels), the device can tell the user how to quickly find a leak. The presence of multiple channels and sensors allows the system to partially, automatically, identify the source of the leak and provide the user with graphical assistance in solving the problem.

As shown in FIG. 25, when the sorbent cartridge 2580 is filled with waste material, it expands and, if not properly attached to the base, may tip over. In one embodiment, the sorbent cartridge 2580 is attached to the base 2520, and is temporarily physically attached thereto, by a plurality of connectors 2540. The base 2520 is a flat structure having connectors 2510 that are configured to be removably connected to docking connectors based on a dialysis system. In one embodiment, the base unit 2520 comprises two docking connectors 2510, with additional docking connectors being provided on the base unit. Connectors 2540 comprise at least two, preferably three, or optionally more than three corner pieces. In a configuration with three 2540 connectors, the connectors are evenly distributed around a circumference that is slightly larger than the perimeter of the base of the 2580 sorbent cartridge. When the sorbent cartridge 2580 is located in the connectors, it sits tightly on them and holds in place due to the weight of the cartridge 2580. The flat surface 2520 further comprises a second set of connectors 2550, which contain at least two, preferably three, or, optionally, more than three corner parts. In a configuration with three 2550 connectors, the connectors are evenly distributed around a circle that is slightly larger than the perimeter of the base of the concentrate vessel. When the container with concentrate is located in the connectors 2550, it sits tightly on them and holds in place due to the weight of the vessel 2550.

Exemplary flow channels of blood and dialysate

The disclosed embodiments may be used to provide dialysis treatment to a patient. FIG. 26 is a functional block diagram of one embodiment of a multi-pass sorbent dialysis system of the present invention. In one embodiment, the dialysis system 2600 uses a dialyzer cartridge 2602 comprising a high throughput membrane to remove toxins from the blood, both by diffusion and convection. Toxins are removed by diffusion by establishing a concentration gradient through a semipermeable membrane, allowing the dialysis fluid to flow on one side of the membrane in one direction and at the same time allowing blood to flow on the other side of the membrane in the opposite direction. To enhance the removal of toxins using hemodiafiltration, saline is continuously added to the blood either before the dialyzer cartridge (preliminary dilution) or after the dialyzer cartridge (subsequent dilution). The amount of liquid equal to the amount of physiological saline added is “ultrafiltered” through the membrane of the dialyzer cartridge carrying the added solutions.

26 and 27, in one embodiment, blood containing toxins is pumped from the patient’s blood vessel by a blood pump 2601, 2701 and transferred to flow through the dialyzer cartridge 2602, 2702. Optionally, the inlet and outlet pressure sensors 2603, 2604, 2703, 2704 in the blood line measure the blood pressure both before it enters the dialyzer cartridge 2602, 2702 through the blood inlet tube 2605, 2705, and after it leaves the dialyzer cartridge 2602, 2702 through a tube 2606, 2706 release of blood. Pressure readings from sensors 2603, 2604, 2628, 2703, 2704, 2728 are used as a parameter for monitoring and controlling blood flow. The flow meter 2621, 2721 can be cut into, or otherwise connected by pressure to, a section of the blood inlet tube 2605, 2705, which is located directly in front of the blood pump 2601, 2701. The flow meter 2621, 2721 is designed to control and maintain a predetermined blood flow in the supply line contaminated blood. Saline solution 2690 can be continuously added to the blood either before the dialyzer cartridge (preliminary dilution) or after the dialyzer cartridge (subsequent dilution).

In one embodiment, according to FIGS. 26 and 27, the dialyzer cartridge 2602, 2702 contains a semipermeable membrane 2608, 2708 that divides the dialyzer 2602, 2702 into a blood chamber 2609, 2709 and a dialysate chamber 2611, 2711. When blood passes through the chamber for blood 2609, 2709, uremic toxins are filtered through a semipermeable membrane 2608, 2708 due to convective forces. Additional blood toxins are transported through the semipermeable membrane 2608, 2708 through diffusion, mainly induced by the difference in the concentration of fluids flowing through the blood and dialysate chambers 2609, 2709 and 2611, 2711, respectively. The dialyzer cartridge used may be of any type suitable for hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration as are known in the art. In one embodiment, the dialyzer 2602, 2702 comprises a high throughput membrane. Examples of suitable dialyzer cartridges include, but are not limited to, Fresenius® F60, F80 manufactured by Fresenius Medical Care of Lexington, Mass., Baxter CT 110, CT 190, Syntra® 160 manufactured by Baxter of Deerfield, Ill., Or Minntech Hemocor HPH® 1000, Primus® 1350, 2000 manufactured by Minntech of Minneapolis, Minn.

In one embodiment of the present invention, the dialysate pump 2607, 2707 pumps the spent dialysate from the dialyzer cartridge 2602, 2702 and injects the dialysate into the dialysate regeneration system 2610, 2710 and back 2613, 2713 into the dialyzer cartridge 2602, 2702 in a multi-pass cycle, thereby generating “Regenerated” or fresh dialysate. Optionally, a flowmeter 2622, 2722 is cut into a spent dialysate supply pipe 2612, 2712 in front of the dialysate pump 2607, 2707, which monitors and maintains a predetermined dialysate flow rate. A blood leak sensor 2623, 2723 is also embedded in a spent dialysate supply tube 2612, 2712.

The multi-pass dialysate regeneration system 2610, 2710 of the present invention comprises a plurality of cartridges and / or filters containing sorbents for regenerating spent dialysate. Due to the regeneration of dialysate using sorbent cartridges, the dialysis system 2600, 2700 of the present invention requires only a small fraction of the dialysate of a traditional single-pass hemodialysis device.

In one embodiment, each sorbent cartridge in the dialysate regeneration system 2610, 2710 is a miniaturized cartridge containing a separate sorbent. For example, the dialysate regeneration system 2610, 2710 may use five sorbent cartridges, each cartridge separately containing activated charcoal, urease, zirconium phosphate, aqueous zirconium oxide and activated carbon. In another embodiment, each cartridge may contain a plurality of layers of the above-described sorbents, and there may be a plurality of such separate multilayer cartridges connected to each other in series or parallel in a dialysate regeneration system. It will be apparent to those skilled in the art that activated charcoal, urease, zirconium phosphate, aqueous zirconium oxide, and activated carbon are not exceptional chemicals that can be used as sorbents in the present invention. In fact, any number of additional or alternative sorbents including polymer based sorbents can be used without departing from the scope of the present invention.

The multi-pass sorbent dialysis system of the present invention provides several advantages over traditional single-pass systems. They include the following.

It does not require a continuous source of water, a separate water purification apparatus or floor drain, since the system of the present invention continuously regenerates a certain amount of dialysate. This improves portability.

The present system requires an electric source with a low current strength, for example 15 A, since the same small volume of dialysate in the system recycles due to diafiltration procedure. Thus, additional dialysate pumps, concentrate pumps and large heaters used for large dialysate volumes in single-pass dialysis systems are not required.

The present system can use small volumes of tap water, within 6 liters, from which dialysate can be prepared for the entire treatment session.

The sorbent system uses sorbent cartridges, which act both as a water purifier and as a means for regenerating the used dialysate into fresh dialysate.

Although the current embodiment has separate pumps 2601, 2701, 2607, 2707 for pumping blood and dialysate through the dialyzer, in an alternative embodiment, a single dual-channel pulsating pump that pumps blood and dialysate through the hemodiafiltration system 2600, 2700 can be used. Additionally, centrifugal, gear or diaphragm pumps can be used.

In one embodiment, excess liquid waste is removed from the spent dialysate in the spent dialysate tube 2612, 2712 using a volumetric waste micropump 2614, 2714 and deposited in a waste collection tank 2615, 2715 that may periodically be emptied through an outlet, such as a tap . An electronic control unit 2616 containing a microprocessor monitors and adjusts the functionality of all components of the 2600 system.

In one embodiment, the diafiltered blood exiting the dialyzer cartridge 2602, 2702 is mixed with controlled volumes of sterile physiological saline, which is pumped into a blood delivery tube 2606, 2706 from saline container 2617, 2717 using a volumetric micropump 2618, 2718. Saline solution usually available as a sterile / non -rogenic liquid in flexible bags. This liquid can also be produced promptly by filtering a non-sterile dialysate through a suitable filter cartridge, which makes it sterile and non-degenerate.

28 is a functional block diagram showing one embodiment of an ultrafiltration treatment system 2800 of the present invention. As shown in FIG. 28, blood from the patient is pumped into the blood supply inlet 2801 by a pump, such as a peristaltic blood pump 2802, which pumps blood into the hemofilter cartridge 2804 through the blood inlet 2803. The inlet and outlet pressure transducers 2805, 2806 are connected in series directly to and after a blood pump 2802. Hemofilter 2804 contains a semipermeable membrane that allows ultrafiltration of excess fluid from the blood passing through it, by convection. The ultrafiltered blood is additionally pumped out from the hemofilter 2804 through the blood outlet port 2807 to the outlet blood line 2808 for re-infusion to the patient. Regulators, such as clamps, 2809, 2810 are used in piping 2801 and 2808 to control fluid flow through it.

A pressure transducer 2811 is connected near the blood outlet port 2807, followed by an air bubble detector 2812 located after the pressure transducer 2811. An ultrafiltrate pump, such as a peristaltic pump, 2813 pumps the ultrafiltrate waste from the hemofilter 2804 through the UV (ultrafiltrate) output port 2814 to the UV output 2815. The pressure transducer 2816 and the blood leak detector 2817 are transposed to the UV output 2815. Finally, the ultrafiltrate waste is pumped into the reservoir 2818 for collecting waste, such as a balloon or soft bag attached to the leg of an outpatient patient and equipped with a drain port, allowing it to be emptied from time to time. The amount of ultrafiltrate waste generated can be controlled using any measuring instrument, including a 2819 balance or a flow meter. The microcontroller 2820 monitors and regulates the operation of blood and UV pumps, pressure sensors, as well as air and blood leak detectors. Standard Luer locks, such as Luer locks and Luer locks, are used to connect the piping to the pumps, hemofilter and patient.

Another conduit for blood and dialysate that can be implemented or used in embodiments of dialysis systems is shown in FIG. 29. Fig. 29 shows a hydraulic system for an extracorporeal blood processing system 2900 used for hemodialysis and hemofiltration. In one embodiment of the present invention, system 2900 is implemented as a portable dialysis system that a patient can use for dialysis at home. The hemodialysis system contains two pipelines - a blood line 2901 and a dialysate line 2902. Dialysis blood treatment involves extracorporeal circulation through an exchanger having a semipermeable membrane — a hemodialyzer or dialyzer 2903. Patient blood circulates in the blood line 2901 on one side of the membrane (dialyzer) 2903, and a dialysate containing the main blood electrolytes in concentrations prescribed by the doctor circulate on the other side in dialysate 2902. Thus, the circulation of the dialysis solution provides control DCCH and setting the concentration of electrolytes in the blood.

The patient line 2904, which transfers contaminated blood to the dialyzer 2903 in the blood pipe 2901, is equipped with a blockage detector 2905, which, in general, is connected with a visual or audible warning signal to signal any obstruction to the blood flow. To prevent blood coagulation, a delivery device 2906 is also provided, for example, a pump, syringe or any other injection device for introducing an anticoagulant, such as heparin, into the blood. A peristaltic pump 2907 is also provided to ensure blood flow in the normal (desired) direction.

A pressure sensor 2908 is provided at the inlet where contaminated blood enters dialyzer 2903. Other pressure sensors 2909, 2910, 2911, and 2912 are provided at various positions in the hemodialysis system to monitor and maintain fluid pressure at desired levels at specific points in the respective pipelines.

At the point where the used dialysis solution from the dialyzer 2903 enters the dialysate 2902, a blood leak sensor 2913 is provided to record and notify of any leakage of blood cells to the dialysate line. A pair of bypass valves 2914 is also provided at the start and end points of the dialysate conduit, due to which, under start-up conditions, or at other times required by the operator, the dialysate flow can bypass the dialyzer, while the dialysate flow can still be maintained, i.e. . for draining or filling operations. Another valve 2915 is provided immediately before the filling / drain port 2916. Port 2916 is used to initially fill the pipeline with dialysis fluid and to remove the used dialysis fluid after and, in some cases, during dialysis. During dialysis, valve 2915 can be used to replace portions of used dialysate with high concentrations, such as sodium, with an appropriate concentration replenishing fluid so that the total component concentration of the dialysate is maintained at the desired level.

The dialysate line is equipped with two peristaltic pumps 2917 and 2918. The pump 2917 is used to pump the dialysate into the waste or waste container, as well as to pump the regenerated dialysate into the dialyzer 2903. The pump 2918 is used to pump the spent dialysate from the dialyzer 2903, to maintain the differential pressure of the liquid on the sorbent 2919 and injecting the dialysis fluid from port 2916 to fill the system or maintain component concentration in the dialysate.

In the dialysate 2902, a sorbent cartridge 2919 is provided. The sorbent cartridge 2919 contains several layers of materials, each of which is involved in the removal of contaminants, for example, urea and creatinine. The combination of these multilayer materials allows you to fill the system with potable water for use as a dialysis solution. It also allows dialysis in a closed cycle. Thus, the sorbent cartridge 2919 allows you to regenerate fresh dialysate from spent dialysate coming from dialyzer 2903. For a fresh dialysate solution, a lined container or tank 2920 of suitable capacity, for example 0.5, 1, 5, 8 or 10 liters, is provided.

Depending on the patient’s requirements and based on a doctor’s prescription, the desired amount of 2921 infusion solution can be added to the dialysis solution. Infusate 2921 is a solution containing minerals and / or glucose that helps replenish minerals, such as potassium and calcium, in the dialysis solution at levels after unwanted removal of the sorbent. A peristaltic pump 2922 is provided to inject the desired amount of infusion solution 2921 into the container 2920. Alternatively, the infusion solution 2921 can be injected into the outlet line from the reservoir 2920. Optionally, a chamber 2923 may be provided to monitor the changing fluid level of the infusion solution as a safety check. , warning about the violation of the flow of the infusate and / or functioning as a sensor barcode for scanning barcodes associated with additives to be used Dialysis. Optionally, an ammonia sensor 2928 may be provided.

A heater 2924 is provided to maintain the temperature of the dialysate in container 2920 at the required level. The temperature of the dialysis fluid can be recorded by a temperature sensor 2925 located immediately before the fluid enters the dialyzer 2903. The container 2920 is also equipped with scales 2926 to monitor the weight and, thus, the volume, fluid in the container 2920 and the conductivity sensor 2927, which detects and monitors the conductivity of the dialysis fluid . Conductivity sensor 2927 provides an indication of the level of sodium in the dialysate.

Medical port 2929 is provided before the patient receives blood from the dialysis system. Another medical port 2930 is provided before the return of pure blood from the 2903 dialyzer to the patient. An air (or bubble) sensor 2931 and a wedge clamp 2932 are used in the pipeline to detect any of the air, gas, or gas bubbles and prevent them from returning to the patient.

Refill kit (s) 2933 is connected to the 2900 dialysis system, which helps prepare the system by filling the 2901 blood line with sterile saline before using it for dialysis. Refueling kit (s) may consist of short pipeline segments with pre-connected tips of the intravenous infusion bag or intravenous needles with a combination thereof.

Obviously, although the inclusion and use of a port that accepts an injection or administration of an anticoagulant is thus disclosed in some of the above embodiments, thereby creating an air-blood interface, such a port can be eliminated if the device can operate with minimal risk of blood coagulation at the ports entry and exit. As further discussed below, the collector design, in particular with respect to the internal structure of the ports of the collector, minimizes the risk of blood coagulation, thereby making it possible to get rid of the air-blood interface to receive an injection or an anticoagulant.

From the foregoing discussion, one skilled in the art can appreciate the complexity of exemplary hydraulic systems for a hemodialysis and / or hemofiltration system. Being implemented in the traditional way, the system looks like a piping network and is too complex for a home dialysis user to configure and use. Thus, in order to simplify the system and facilitate its use by the patient at home, embodiments of the present invention implement hydraulic systems in the form of a compact manifold in which most components of the hydraulic system form a single molded plastic part or multiple molded plastic parts that are configured to be connected with each other with the formation of a single workable collector design.

Sample collectors

Obviously, the multi-pass therapeutic dialysis processes represented by the pipelines for blood and dialysate described above can be implemented in, and by, a plurality of pipelines for blood and dialysate molded in a disposable collector. As shown in FIG. 21, embodiments of a dialysis system disclosed herein operate using a manifold 2130 that forms a plurality of blood and dialysate pipelines and provides hydraulic, thermal, and / or optical fluid communication with various sensors, gauges, and pumps.

In one embodiment, the collector of the present invention comprises a composite plastic collector in which flow channels for blood and dialysate are formed. The components of a blood purification system, such as sensors and pumps, are in hydraulic, thermal and / or optical communication with the fluid flow contained in a molded manifold. 30 illustrates the structural elements of a compact collector, according to one embodiment of the present invention. A disposable manifold pumps and directs fluid flow while measuring pressure in critical areas. These fluids include blood, dialysate, infusion, and anticoagulant. In addition, the collector provides signs for detecting blood leakage from the dialyzer, detecting obstruction in the arterial line, and detecting air in the venous line.

30, in one embodiment, the compact manifold 3000 comprises a plurality of layers of plastic with components firmly attached to them. In a more particular case, the collector 3000 contains the following elements:

- back cover 3001

- membrane 3002 pressure transmitter

- valve membranes 3003

- average body 3004

- front cover 3005

- tubular segments of the pump (not shown in Fig.30)

The middle body layer 3004 contains molded channels on one side. These channels end with a layer of the front cover, which is firmly attached to the middle body in any number of ways, including ultrasonic welding. This combined design of the front cover and middle body forms the main part of the fluid ducts in the manifold. On the opposite side of the middle body 3004, there are features that form surfaces for valve control and pressure recording that communicate with fluid ducts on the side of the front cover of the manifold. The manifold includes elastomeric components for valve control and pressure recording. These elastomeric components are trapped between the back cover layer and the middle body layer by ultrasonic welding and complete the fluid ducts in the reservoir.

30, in one embodiment, the manifold 3000 comprises five pressure transmitter membranes 3002 and three to four two-way valve membranes 3003. In one embodiment, the two covers 3001 and 3005 and the middle body 3004 of the collector 3000 are formed of polycarbonate material or ABS (a copolymer of acrylonitrile, butadiene and styrene). Pressure transducer membranes 3002 and valve membranes 3003 are formed from a common material, such as santoprene or, more preferably, sarlinka, which is a medical elastomeric polymer. In one embodiment, the front and back covers 3005 and 3001 can be formed of optically pure material that is at least transparent to certain pre-selected wavelengths of light, which allows spectroscopic analysis of the liquid (s) contained in them.

Additionally, the collector preferably includes four pump components. These pump components are segments of an extruded PVC pipe whose composition and dimensions provide properties optimized for use as a pump, in particular a peristaltic pump. This pipeline is connected to studded fittings that are molded together with the middle body of the collector. One of the four pump components is designed to pump blood from a patient’s artery and pump it through the dialyzer and back into the patient’s vein. Two pump components are designed for dialysate flow and one for infusion delivery to the dialysate line. A separate syringe pump can be used to pump an anticoagulant into the duct of arterial blood, a pre-analyzer.

In one embodiment, the collector further includes conduit ports, preferably between 10-14, and more preferably 12 ports, for connecting all fluid ducts in the manifold to other components of the disposable kit, including a dialyzer, sorbent cartridge, batch a reservoir, an infusate container, a patient’s blood line, an anticoagulant, sensors, a filling and draining line, which are further discussed below.

In one embodiment, the collector is made in the form of a capital letter “I”, the first segment and the second segment of which are parallel to each other and the connecting segment of which a) is perpendicular to the first segment and the second segment and b) serves to connect the first and second segments. In one embodiment, the connecting segment connects the middle of the first segment with the middle of the second segment, so that the distance between the connecting segment and each end of the first and second segments is the same. Obviously, the connecting segment can be located at the ends of the first and second segment, thus forming the capital letter “C” or inverted “C”. The collector can also be rotated relative to the dialysis system and does not have to be in the form of a capital letter “I”, for example, it can be located horizontally or at an angle. As shown in FIG. 32, in an exemplary embodiment, the collector 3200 has the following dimensions: L1 and L2 are from 4 to 7 inches and preferably about 5.7 inches, L3 and L4 are from 0.5 to 1.5 inches and preferably about 1 inch, L5 is from 2.5 to 4.5 inches, and preferably about 3.5 inches, and L6 is from 1 to 3 inches, and preferably about 1.8 inches. Although dimensions have been given, it is obvious that the invention disclosed herein is not limited to any particular size or set of sizes.

In one embodiment, the assembly process of the collector 3000 comprises docking the back cover 3001 with the middle body 3004 while simultaneously seating the membranes 3002 and 3003 in place, whereby the first side of the membranes is physically attached to the middle body or touches it and the second side of the membranes passes through the holes, gaps or voids 3011 in the back cover 3001. The cover 3001 can be divided into two sections, an upper section and a lower section, the upper section comprising an upper section of a central vertical section 3082 and an upper horizontal sections 3080, and the lower portion contains the lower portion of the central vertical portion 3084 and the lower horizontal section 3085. In this embodiment, the upper and lower portions of the cover 3001 may be separately attached to the middle body 3004 and, compared to the integral cover 3001, may not include self material in the region 3083 of the middle section of the central vertical section to save material. Preferably, the second side of the membranes has a tiered structure that allows the first tier to pass through the cavity 3011, while the second tier remains between the back cover 3001 and the middle body 3004. This allows you to close the membranes 3002, 3003 in the back cover 3001. In addition, preferably so that the middle body 3004 contains recesses in which the first side of the membranes 3002, 3003 is located, so that they are attached to the middle body 3004. In an alternative configuration, the membranes 3002 and 3003 can be jointly molded to the back cover 3001 in the process multi-impact molding.

It will be apparent to those skilled in the art that the various collector components may be coupled or connected to each other using any suitable means. In one embodiment, the seal between the middle body and the back cover is achieved by ultrasonic welding or adhesive. Alternatively, laser welding may be used. The front cover is connected to the other side of the middle body in a similar way. The pump tubing segments, in one embodiment, are solvent-seated in place, or, in an alternative embodiment, the segments can be laser welded using a laser-absorbing additive in plastic.

In one embodiment, the front cover is molded from BASF Terlux 2802HD ABS, which is transparent and provides visibility to the fluid duct. The transparency of the ABS also provides a means of monitoring the integrity of surfaces obtained by ultrasonic welding. ABS is preferred because of its biocompatibility as well as compatibility with ultrasonic welding. Additionally, the front cover may include a molded textured surface to facilitate bonding between the front cover and the middle body. This textured surface is a chemical etching process that is known to those skilled in the art. One preferred texture depth is 0.0045 ”. Other suitable textures can also be obtained by laser etching. The surface to be welded on the front cover is provided with a notch of 0.003 ”, which goes into a raised surface of 0.003” on the mold. This provides an accurate surface for receiving texturing. When texturing takes place on the mold, the height of this surface is 0.003 ”. Due to peaks and troughs at a texture depth of 0.0045 ”, it is assumed that the average will be half this value or 0.00225”. The result will leave the mold in a 0.00075 ”steel-protected condition. The cover 3005 may also be in the form of only a central vertical portion 3090 and not include upper and lower horizontal portions 3091, 3092. The central vertical portion 3090 can be attached to the middle body 3004 by placing it in a recessed area formed by raised edges on the surface of the middle body 3004, the opposite surface of the lid 3001, and fixing section 3090 in the recessed area.

In one embodiment, the anterior cap provides directors of blood flow in the arterial and venous ducts. These signs are designed to minimize hemolysis. Blood flow directors provide a consistent cross-sectional area over the duct and minimize the sharp edges with which blood would come into contact in their absence. The wall on the opposite side of the blood flow directors is released to provide a more consistent wall thickness in the molded plastic part. This will prevent lows in this area that will affect the surrounding welded surfaces. In one embodiment, the wall thickness of the front cover is 0.075 ”.

Optionally, the front cover has mounting holes provided for assembly purposes to ensure accurate alignment of the front cover and middle body during the ultrasonic welding process. Raised bulges around the mounting holes help maximize contact with the alignment pins of the weld fittings to make it difficult to melt the plastic due to friction. These thickenings do not touch or weld with the middle body to ensure that the hole is open.

FIG. 31 provides a perspective view of a medium body component of a compact collector of the present invention. As shown in FIG. 31, the completed flow channels 3101 for blood and dialysate of the hemodialysis / hemofiltration system are formed in the middle body. Accommodations for the various functional elements of the blood purification system, such as pumps, valves and sensors, are also integrated in the middle section of the compact manifold.

The middle body can be molded from BASF Terlux 2802HD ABS. Another alternative ABS is Lustran 348, White. ABS was chosen for its biocompatibility as well as compatibility with ultrasonic welding. The middle body together with the front cover provides flow channels for the collector. The middle body contains energy directors for butt welding type ultrasonic welding. In one embodiment, the dimensions of the energy director are 0.019 "in height with a base width of 0.024". This gives a cross-sectional area of 0.00023 square inches. The width of the welding surface is 0.075 ”, which gives a welding volume of about 0.003” × 0.075 ”. The energy director for the type of butt joint is preferable to other types, such as lap joint, tongue and groove joint, splined joint, due to its simplicity and the ability to control the geometry of the mold. Ventilation holes are provided in the geometry of the weld to prevent entrained gases from breaking through the welds, resulting in weak welds that can leak.

The back cover side of the middle body preferably provides a molded textured surface to facilitate bonding between the back cover and the middle body. This textured surface is a chemical etching process that is known to those skilled in the art. The preferred texture depth is 0.0045 ”. Other suitable textures can also be obtained by laser etching. The surface to be welded on the middle body is provided with a notch of 0.003 ”, which goes into a raised surface of 0.003” on the mold. When texturing takes place on the mold, the height of this surface is 0.003 ”. Due to peaks and troughs at a texture depth of 0.0045 ”, it is assumed that the average will be half this value or 0.00225”. The result will leave the mold in a 0.00075 ”steel-protected condition.

The size of the components to be welded can have a decisive influence on the success of the ultrasonic welding process. The larger the surface area, the more difficult the welding process becomes. It is important to precisely control the welding surfaces. The agreed thickness of the front and back covers is more important than flatness, since a cover with a slight misplacing will be flattened under pressure during the welding process. Flatness on the middle body is important due to the structural design, which will prevent its flattening during the welding process. In connection with these problems, it is very important that the parts are correctly designed and not subject to such anomalies as warping, lowering, resizing, etc. In addition, the design and quality of the mold must meet the same high standards as the details must meet. It follows that the control of the molding process must also meet the highest standards.

The back cover can be molded from ABS BASF Terlux 2802HD. The back cover contains energy directors for ultrasonic butt welding. The dimensions of the energy director are 0.019 "in height with a base width of 0.024". This gives a cross-sectional area of 0.00023 square inches. The width of the welding surface is 0.075 ”, which gives a welding volume of about 0.003” × 0.075 ”. This 0.003 ”welding volume should be considered when determining the geometry of the assembled components. Ventilation holes are provided in the geometry of the weld to prevent entrained gases from breaking through the welds, resulting in weak welds that can leak. Mounting holes in the back cover are provided for assembly purposes to ensure accurate alignment of the back cover with the middle body during the ultrasonic welding process. Mounting holes in the back cover also ensure accurate alignment of the manifold and instrument when loaded correctly. Raised thickenings around the mounting holes are designed to maximize contact with the alignment pins of the welding fittings to make it difficult to melt the plastic due to friction. These thickenings are not touched or welded to ensure that the hole is open.

Ultrasonic welding was chosen as a way of bonding the three main components of the collectors due to the low cost of this manufacturing process. The relatively low cost of equipment and the short cycle for creating a welded joint are the reason for these low production costs. When the parts are loaded into the reinforcement, the welding cycle with moving and removing the horn can be carried out in seconds. The actual welding time is about one second. Other bonding methods include hot plate, laser, and UV adhesive.

As shown in FIG. 31, in one embodiment, three two-way valves 3107, five pressure transducers 3106, an obstruction detector, an air bubble detector, and a blood leak detector are integrated in the middle body section 3100. It will be apparent to those skilled in the art that the number and type of functional components integrated in the middle body section 3100 may vary according to the requirement and application of the blood purification system, and thus may include 1, 2, 3, 4, 6, 7, 8, 9, 10 or more pressure transmitters, 1, 2, 4, 5, 6, or more two-way valves, 0, 2, 3, 4, or more blockage detectors, 0, 2, 3, 4, or more air bubble detectors, 0, 2, 3, 4 or more blood leak detectors. Additionally, the middle body section 3100 comprises a plurality of ports 3103, 3104.

Ports include internal ports 3104 through which fluid flows through pump segments (not shown) from and between the first and second segments of manifold 3100. In one embodiment, the first segment has four internal ports 3104, two on each side of the connection point of the first segment and connecting segment. Obviously, 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 on each side of the connection point of the first segment and the connecting segment. Obviously, the second segment may have 1, 2, 3, 5, 6, 7 or more internal ports. Additionally, it is preferable that the position and position of the internal ports of the first segment reflect the position and position of the internal ports of the second segment. Ports also include external ports 3103 to elements external to collector 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 a 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.

The inclusion of elements in contact with the liquid in the collector, as described above, allows you to design systems where reusable sensors are installed in the dialysis machine to which the collector is attached, while the fundamentally disposable elements in contact with the liquid are separated and located in the collector. To ensure correct readings and measurements, fluid contact elements and reusable sensors must be aligned. Docking and alignment between the collector and the dialysis machine play an important role in terms of positioning and applied pressure. Typically, such docking accuracy should provide a tolerance of 0.001 ”to 0.010” in the X, Y, and Z directions and a mounting force of 10-100 PSI to overcome the resistance of the fluid to the collector. This important positioning is achieved through specially designed collector positioning surfaces that are compatible with additional dialysis unit positioning surfaces. The necessary forces are delivered by analysis and design of the dialysis machine so that the deviation of the X and Y positions and the Z direction is less than about 0.001 ”to 0.010” at all hydraulic and mechanical pressures developed in the collector during operation. Since the collector contains a large number of structures on one monolithic basis, this important alignment needs to be done only once to position all the features of the collector with all the docking features of the dialysis machine.

The size of the channel of the average body is nominally 0.190 ”in depth by 0.190” in width with radii of 0.020 ”at the lower corners of the channel on the middle body side. The radius at the lower corners of the channel should be maximum to prevent the occurrence of lows under the walls of the channel. These channel walls have valve geometry and pressure diaphragms on the opposite side of the middle body, which are negatively affected by a decrease in these areas. In one embodiment, the fluid ducts are square. A general design rule to prevent lowering is that the wall thickness of the rib (in this case, the channel wall) should be more than 50-60% of the adjacent wall to which it is attached. The channel wall has a thickness of 0.075 ”, and the adjacent wall (main collector structure) has a thickness of 0.130”, which gives 58%. Dialysate channels of 0.190 ”× 0.190” size go into the 0.155 ”pipe port through openings. This minimizes the accuracy needed to align the front cover with the middle body and minimizes the possibility of lowering due to thicker walls, which can affect the signs of sealing on the opposite side of the middle body. The same approach is used for anticoagulant and infusate channels. Channels are designed as smooth curves to maximize laminar flow and minimize turbulent flow. In one embodiment, the anticoagulant and infusate channels, as discussed below, are 0.190 ”deep 0.100” wide.

In one embodiment, the middle body has mounting holes for assembly purposes to ensure that the front cover and the back cover are precisely aligned with the middle body during the ultrasonic welding process. Raised bumps around the mounting holes maximize contact with the alignment pins of the welding fittings to make it difficult to melt the plastic due to friction. These thickenings are not touched or welded to ensure that the hole is open.

33 is a detailed diagram of a hydraulic system for a compact manifold according to one embodiment of the present invention. The hydraulic system contains four tubular segments of the pump P1 3301, P2 3302, P3 3303 and P4 3304, connected by pressure to the pumps in the upper control unit and the pump blocks in the door of the upper control unit. It additionally contains five pressure membranes, connected in pressure with the sensors S1 3305, S2 3306, S3 3307, S4 3308 and S5 3309 pressure, and the area in thermal or optical connection with the sensor S6 3310 temperature. According to the embodiment illustrated in FIG. 33, three pairs of membranes are embedded in the manifold, V1A and V1B 3311, V2A and V2B 3312 and V3A and V3B 3313. The membranes function as valves when they are plugged with a pin, part or protrusion from the control unit.

The pairs thus assembled from six single-pass valves, 3311 A, B, 3312 A, B, 3313 A, B, form three assemblies 3311, 3312, 3313 of two-way valves. Two-way valves provide increased flexibility in piping configuration management. When traditional two-way valves are used to shut off portions of a fluid duct, they are typically configured to provide two different fluid ducts, one for a first valve state and one for a second valve state. Certain valve embodiments, as described below, used in conjunction with valve diaphragms or pressure points integrated in the manifold provide more nuanced control, allowing four different fluid flow paths to be created.

The tubular segments of the pump 3301, 3302, 3303, 3304 are integrated in a compact manifold. The manifold has several ports for connecting to tubes external to the collector to allow the flow of various fluids into and out of the collector. These ports are connected to various tubes in the blood purification system to transfer fluids as follows:

port A 3315 - blood into the dialyzer 3330;

port B 3316 - dialyzer output (used dialysate);

port C 3317 - blood from the patient;

port D 3318 - heparin for mixing in the blood;

port E 3319 - tank outlet (fresh dialysate);

port F 3320 - dialyzer input (fresh dialysate);

port G 3321 - dialyzer output (blood);

port H 3322 - return to the patient (pure blood);

port J 3323 - connects the filling and drain lines;

port K 3324 - input of the reservoir of the infusate;

port M 3325 - infusate inlet from the infusate reservoir;

port N 3326 - dialysate flow into the sorbent.

In one embodiment, a tubular segment made in the form of a duct formed in the manifold 3300 connects a heparin fluid stream 3314 through port D 3318 with a blood fluid stream through port C 3317. Heparin and blood flow together through port 3317a through the pump segment 3301 to port 3317b of the manifold 3300. The pressure transmitter is physically connected to a membrane 3305 formed in the collector structure 3300, which in turn passes blood and heparin fluid through port A 3315. The fluid flow from the lecturer 3300 on port A 3315 passes through a dialyzer 3330, which is external to the collector 3300. The dialyzed blood passes back to the collector 3300 through port G 3321 and to segment 3307, made in the form of a duct molded into the collector structure 3300, which is physically connected with pressure transmitter. The fluid then passes from the segment through port H 3322 and back to the patient.

Separately, the dialysis fluid enters the 3300 collector from the reservoir through port E 3319. The fluid in the reservoir contains an infusate, which first enters the 3300 collector through port M 3325, passes through a segment configured as a duct molded into the 3300 collector structure, through another port 3325a, through a segment 3302 connected to the pump, and back to the collector 3300 through port 3325b. The infusate passes through a segment made in the form of a duct, formed in the collector structure 3300, and from the collector 3300 at port K 3324, where it enters the reservoir. The dialysate entering the collector through port E 3319 passes through a segment formed as a duct formed in the collector structure 3300, through another port 3319a, through a segment 3303 connected to the pump, and back to the collector 3300 through port 3319b.

The dialysis fluid enters a segment made up of a duct molded in a manifold 3300, which is physically connected to a pair of valves 3311. A segment made in the form of a duct molded in a manifold 3300 passes a dialysis fluid to another pair of valves 3313. The segment is physically connected with pressure transmitters 3308 and an optional temperature sensor 3310. The dialysis fluid passes from the 3300 collector through port F 3320 and into a line that is connected to the 3330 dialyzer.

A line from dialyzer 3330 passes fluid back to manifold 3300 through port B 3316 and to a segment made in the form of a duct formed in manifold 3300, which is physically connected to a first pair of valves 3311, a second pair of valves 3312, and a pressure transmitter 3306. Used dialysis fluid passes from collector 3300 through port 3326b, through segment 3304 connected to the pump, and back to the collector through port 3326a. The segment in fluid communication with port 3326a is physically connected to pressure transducer 3309 and passes liquid through port N 3326 to the sorbent regeneration system.

Ports are for the piping system of the 0.268 ”× 0.175” pipeline or the anticoagulant and infusion 0.161 ”× 0.135” pipeline. Preferably, the ports of the pipeline are associated with a suitable solvent.

Obviously, the valves 3311, 3312, 3313 shown in FIG. 33 may occupy different positions in the manifold. 86, valve 8611 (valve 3311 in FIG. 33) may be located in parallel to and parallel to valve 8612 (valve 3312 in FIG. 33) in a central vertical portion 8650 of manifold 8600. Also, in a central vertical portion 8650 of the manifold 8600, which connects the upper horizontal portion 8630 and the lower horizontal portion 8640, a valve 8613 is provided (valve 3313 in FIG. 33). Valve 8613 is located in the lower portion of the central vertical portion 8650 and is located substantially below and in the middle between valves 8611, 8612.

In one embodiment, the two-way valves operate by the presence of valve actuators that are mounted on the device, press the elastomeric diaphragm against the volcanic seal to prevent the dialysate from flowing through its corresponding duct, which is described in more detail below. The volcanic seal bore is approximately 0.190 ”in diameter in accordance with the channel geometry. The cross section of the duct through the interior of the valve is at least equivalent to a diameter of 0.190 ”with the valves open. When the valve is in the closed position, the valve actuator and elastomeric diaphragm occupy most of the clearance around the volcanic seal, minimizing the possibility of air entrainment. On the middle body there are raised plastic features that minimize dead space in the flow channel, and also prevent the diaphragm from compressing around the center of the flow channel under conditions of negative pressure. The elastomeric diaphragm has the sign of a sealing ring around its perimeter, which is located in a groove on the surface of the middle body. The seal ring is clamped between the middle body and the back cover to form a liquid tight seal. The design provides approximately 30% compression on the o-ring. Two-way valves control the direction of dialysate flow through the manifold.

The collector contains designs that allow you to control the pressure drop across the diaphragms by using sensors in the device. The possibility of fluid flow from the channels on the side of the front cover of the middle body through the inlet and outlet openings under the diaphragm on the side of the back cover is provided. The cross section of the duct through the inner region of the pressure recording structure is at least 0.190 ”equivalent. The internal duct is designed to minimize air entrainment while ensuring adequate fluid contact with the diaphragm. The elastomeric diaphragm has the sign of a sealing ring around its perimeter, which is located in a groove on the surface of the middle body. The seal ring is clamped between the middle body and the back cover to form a liquid tight seal. The design provides 30% compression on the o-ring.

Valves and diaphragms can be made of various materials and through various processes. In one embodiment, the elastomeric components are made of silicone. In another embodiment, the elastomeric components are made of various thermoplastic elastomers. Double-impact molding can be used to attach valves and diaphragms to the back cover. Double-impact molding of valves and diaphragms eliminates the need for individual assembly of these parts into the manifold, which reduces labor costs and improves the quality of the collector assembly.

Pump components in the collector design are made in the form of a PVC intake pipe. These receivers, combined with a rotational peristaltic pump system of the device, provide a flow of blood, dialysate and infusate. The material of the piping system for dialysate, infusate and anticoagulant is preferably fracture resistant, for example, in the form of tubes called Colorite, Unichem PTN 780 (80A hardness tester), extruded by Natvar and all TEKNIplex companies. Tube sizes for dialysate lines are in the range of 0.268 ”× 0.189” to 0.268 ”× 0.175”.

In order to ensure effective thermal, optical, or hydraulic connection of the collector segments with one or more sensors through elastic membranes, it is important to create a fairly close contact of the fluid flow with the recording device. One way to do this is shown in FIG. 34. The collector segment 3400 receives a fluid stream 3410 that is forced to move upward due to blocking and redirecting the position of the protrusion, part, or other structure 3408 in the flow channel 3410. The fluid moves upward and concentrates between the membrane 3405 and the structure 3408, which improves registration. However, such an embodiment may lead to the formation of blood clots in bends 3401, 3415 or blockages due to adhesion of the base 3406 of the membrane 3405 to the upper part 3407 of the structure 3408 due to negative pressure.

As shown in FIGS. 35A and 35B, in order to minimize the possibility of blood clots or clogging, it is therefore preferred that the design of the collector segments 3500, which are in thermal, optical or hydraulic communication with one or more sensors through resilient membranes 3505, also referred to as recording segments was designed so as to avoid creating sharp turns, bends or horseshoe-shaped channels that can increase the likelihood of thickening or clogging, but still provide sufficient th contact between the flowing fluid and the sensor located on or near the segment. 35A and 35B, the inner fluid duct 3515 is now formed by an upper surface containing a membrane 3505 that provides thermal, optical, or hydraulic connection of the sensor through duct 3515, and a lower surface formed by a) the first upwardly sloping wall 3525, which reduces the height of the duct 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 duct height 3515 equal to the second height, and c) a beveled wall 3527 that increases the height of the duct 3515 rivers of wall length 3527 from a second height again to a first height. The tilt up / down of walls 3525, 3527 leads to a narrowing of the fluid duct 3515. However, at the same time, the width of the segment formed by the inclined walls 3525, 3527 and the flat segment 3526 increases compared with the collector sections before and after the recording segment. Reducing the height and increasing the width of the recording segment relative to the collector segments before and after the recording segment provides a substantially constant fluid velocity, thereby avoiding velocity changes that can hemolize the blood, eliminating dead spaces and maintaining a low Reynolds number, while ensuring the required contact area for the flexible membrane 3505, through which the sensors take measurements. In one embodiment, one or more struts 3535 are embedded in the fluid duct 3515, above a flat surface 3526 and below the membrane 3505 to prevent the membrane 3505 from completely contracting due to negative pressure.

As follows from the above discussion, pipelines for blood and dialysate of the collector can be formed by a single molded plastic part, rather than a plurality of plastic components welded together. However, when the pipelines for blood and dialysate are formed by a single solid piece of material, certain problems arise. In particular, the ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b in Fig. 33 are difficult to form economically and reliably if the protrusions of a cylindrical shape forming each port extend directly perpendicular to the surface of the collector or, in other words, are inclined at an angle of essentially zero degrees to the side of the collector portion to which the cylindrical protrusion is attached. If the ports are made in a completely perpendicular configuration, the pins from the molding machine are not easy to remove. 33 and 36, it is preferable to produce ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b when the cylindrical protrusion defining the port structure 3655 is inclined relative to the side of the manifold 3645 to which the protrusion 3655 connected by the surface 3675 is connected Thus, in one embodiment, the internal ports of the collector are angled relative to the surface of the collector. This angle further reduces stress on any tubular segment of the pump that is inserted between two tilted ports. This additionally gives the tubular segment of the pump a slightly curved, curved or other non-linear shape for better alignment with the contact surface of the pump receiver. In one embodiment, the angle formed by the line normal to the center of the inclined port and the line normal to the collector side is less than 20 degrees and preferably less than 10 degrees. In one embodiment, the angle is approximately 10 degrees. In one embodiment, the internal ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b of the collector are fabricated at the aforementioned angle, while the remaining ports are fabricated at an angle approximately equal to zero. In another embodiment, the protrusions 3655, being described as cylindrical, have inner regions or volumes 3753, the base 3754 of which is substantially flat and not curved, while the rest of the internal structure forming the volume 3753 remains curved 3756, as shown in Fig.37. In another embodiment, all ports or fluid ducts have internal regions or volumes 3753, the base of which 3754 is substantially flat and not curved.

Another embodiment of the collector is shown in Figs. 38-40, where the flow channels for blood and dialysate are formed in a single compact plastic block. In one embodiment, the collector 3800 is an easy-to-assemble compact plastic block into which molded flow channels for blood and waste are integrated. Optionally, sensors, pumps, and hemofilter cartridges can also be combined with a compact plastic block by inserting them into concave moldings in the block. In one embodiment, the dialysis system of the present invention is capable of operating for more than 8 hours during a treatment session and up to 72 hours continuously. Obviously, fluid flows into and out of the collector through certain inlet and outlet ports, for example, to and from external pumps, to the UV waste tank or to the patient return line.

FIG. 39 shows a modular assembly of a manifold 3900 in one embodiment of the present invention. Pump section 3930 contains pumps 3903, 3913 for blood and waste, respectively. Module 3940 comprises molded flow channels 3942 for blood and ultrafiltrate waste and a hemofilter module 3950 comprising a hemofilter cartridge 3908. This modular design allows you to quickly and easily assemble various modules into a single compact design.

On Fig shows an enlarged view of the module 3940 of the middle body shown in Fig. In one embodiment, the middle body module 4040 comprises integrated molded flow channels 4041 for transferring blood and waste. The connection ports 4042 are also molded into the middle body module for connection (via Luer connectors and piping) with pumps on one end of the middle body module 4040 and with a hemofilter cartridge on the other end of the middle body module 4040.

Returning to FIG. 38, blood is pumped into the manifold 3800 through the blood inlet port 3801 and the molded flow channel 3802 using a volumetric blood pump 3803, which is connected in pressure to the tubular segment of the collector. A volumetric blood pump 3803 pumps blood into the hemofilter cartridge 3808 through a molded flow channel 3804. Areas 3806, 3807 of the inlet pressure sensors are also integrated into the collector 3800 in the molded flow channels 3802, 3804.

Returning to FIG. 38, waste from the permeable region 3809 is pumped out by the volumetric waste pump 3813 through the molded flow channel 3814, which, in one embodiment, has an integrated pressure sensor region 3815 located along the flow channel 3814. The waste is pumped through the molded flow channel 3816, which, in one embodiment, has an integrated blood leak detector area 3817 and a waste flow meter 3818, in series with a flow channel 3816 leading from the collector 3800 through the waste discharge port 3819 at.

In one embodiment, the hemofilter cartridge 3808 is disposable and may be integrated with the ability to remove into the corresponding molded concavity in the manifold 3800 to complete the ultrafiltration line. The 3800 manifold also interfaces with an excess clamping valve to prevent air from entering the patient's vascular system. The clamping valve is designed so that it is in a closed (clogged) position in the absence of supply of electrical power.

The molded flow channels 3802, 3804, 3810, 3814 and 3816 form the flow channels of blood and ultrafiltrate of the collector 3800. In one embodiment, these flow channels contain a disposable conduit and many interface components, for example, compounds that are suitable for contact with blood and ultrafiltrate in for at least 3 days. The compounds are preferably designed to have a strength of at least 5 pounds and a seal for 600 mmHg. Art. (which exceeds the maximum pressure drop across the hemofilter membrane). In one embodiment, the blood line corresponding to the flow channels 3802, 3804 and 3810 have a length and an inner diameter suitable for providing blood flow of 50 ml / min. In one embodiment, the filling volume of the blood line including a hemofilter is less than 40 ml. The bloodline mates with a volumetric blood pump 3803. Blood pump tubing 3803, in one embodiment, is sold under the brand name Tygon, composition S-50-HL, size 1/8 ”VD × 3/16” ND × 1/32 ”wall.

Similarly, in one embodiment, the ultrafiltrate line corresponding to flow channels 3814 and 3816 is capable of providing an ultrafiltrate flow rate of 500 ml / h (8.33 ml / min). The ultrafiltrate line also interfaces with the 3813 waste volume pump. The pipeline of the waste pump 3813, in one embodiment, is sold under the brand name Tygon, composition S-50-HL, size 3/32 ”HP × 5/32” HP × 1/32 ”wall.

Because the collectors of the present invention contain molded flow channels for blood, dialysate, liquid waste, and blood substitute fluids, the entire flow channel can be easily manufactured as portable composite collectors. Collectors are also easy to handle, since all flexible tubes outside the collectors are attached to one side of the collectors. The use of manifolds with integrated molded flow channels increases the reliability of treatment, since the likelihood of disconnection, improper assembly and leakage is minimized compared to traditional systems that use a large number of flexible tubes. The use of new collectors also simplifies use, resulting in increased portability.

In one embodiment, the dialysis collectors are autonomous compact units, which allows them to be used individually and separately for treating a patient’s blood. In another embodiment, the two collectors may be connected to each other to function as a two-stage blood processing system. In one example, blood is pumped out of a patient’s arterial region and passed through a dialyzer, where a large amount of liquid waste is removed by convection. The collector is used to return an equal amount of fluid back to the blood, before re-infusion of blood. The collector measures and discharges liquid waste into a waste bag.

As is well known to those skilled in the art, the hemofilter or dialyzer cartridge 3808 further comprises a hollow tube further comprising a plurality of hollow fiber tubes, the walls of which play the role of a semipermeable membrane. Many tubes of semi-permeable hollow fiber divide the cartridge 3808 hemofilter in the region of 3805 blood flow in the tubes of hollow fiber and the filtrate or permeable region 3809 outside the tubes of hollow fiber. As blood passes through the 3805 blood region, plasma water passes through semipermeable hollow fiber tube membranes. Cartridge 3808 hemofilter is a small hemofilter. More concentrated blood flows from the cartridge 3808 through the molded flow channel 3810 and from the collector 3800 through the blood outlet port 3811. An air detector region 3812 is also integrated into the return blood flow channel 3810.

The following are exemplary physical specifications for a hemofilter, or dialyzer, 3808 in accordance with one embodiment of the present invention:

membrane surface area (m ² ) ≤0.1 filling volume (ml) ≤10 molecular weight cut-off (daltons) 65,000 Pressure drop 3 (mmHg) ≤50 (Qb = 50 ml / min)

maximum pressure drop across the membrane (mmHg) ≥500 full block length (cm) 12-15 filtration rate 8-10 ml / min at 100 mm Hg. Art. at 50 ml / min Qb pipe connections blood Luer tip filtrate sliding landing (direct) sterilization ETO or gamma membrane material polysulfone (preferred) case material polycarbonate Insulation material polyurethane Filter coefficients urea 1.00 creatinine 1.00 vitamin B12 0.98 average molecule / size ≥0.20
17000 albumen ≤0.03

During treatment dialysis, a patient or health care provider installs one of the above collectors in a dialysis machine. As shown in FIG. 41, the dialysis apparatus 4101 has a front door 4103 that can be opened wide to accommodate disposable components. For installation, the collector 4104 just needs to be inserted into the space provided for this in the dialysis unit 4101, as discussed earlier. The installation of the dialyzer 4102 also provides for a simple insertion into the intended recess. The front door 4103 is equipped with pump pads 4105, which makes it very easy to load disposable components, since there is no need to connect the pump pipeline between the roller and the pads by means of a threaded connection. Additionally, this configuration allows the dialyzer 4102 and the collector 4104 to be installed in such a way as to ensure proper alignment with non-disposable components, such as pressure gauges, sensors and other components. This compact, simple approach makes it easy to load supplies and clean the system. It also ensures that the piping is correctly configured and ready for use.

42, in one embodiment, a manifold 4202 is mounted on a vertical front panel 4203 of the dialysis system 4201. A collector 4202 is precisely positioned on this panel 4203 by a plurality of alignment mechanisms. The first alignment mechanism comprises a plurality of alignment pins in the panel 4203 that fit into the mounting holes in the manifold 4202. The second alignment mechanism comprises at least one latch that supports the manifold 4203 in a specific mounting position until the door 4206 is closed and the final exact position. In one embodiment, the rear cover of the manifold 4202 has two strips embedded in the structure at the top and bottom. These strips lock the manifold 4202 in the first holding position until the door 4206 is closed and the exact position of the manifold 4202 is subsequently placed. The planks provide a locking mechanism that can be released manually or by means of ball retainers that require manual removal of the manifold 4202. In another embodiment, the latch mechanism comprises a spring-loaded insertion and release mechanism at the top of the back cover. This mechanism had a connecting rod between the upper latch and the lower latch. When the release mechanism in the upper part is activated, the lower latch is also released.

The third leveling mechanism comprises curly rails 4208 that guide the overall position and configuration of the manifold 4202. The curved rails 4208 are preferably shaped to fit, align with, or otherwise match the physical design of the manifold 4202. In one embodiment, the rails 4208 are, generally rectangular and configured to enter a space bounded by the sides of the first segment, the second segment, and the connecting segment of the manifold 4202, as described above. The fourth leveling mechanism comprises a door 4206 having at least one spring-loaded pressure plate 4205 that grips a manifold 4202 between the door 4206 and the front panel 4203, thereby applying adequate pressure for valve control and pressure recording. Door 4206 also includes four pressure pads that apply adequate pressure to the pump components of the rotational peristaltic fluid delivery.

Obviously, one or more of the equalization mechanisms can be used, individually or in combination, to achieve the required pressure equalized and water position for the reservoir. It is also obvious that alignment mechanisms are attached to the surface of the recessed region in the shell of the dialysis device. The recessed region comprises a front panel 4203, which is recessed relative to the dialysis device body and is limited by four walls (first wall, second wall, third and fourth wall), which extends upward from the front panel 4203, reaching and firmly joining the dialysis device shell. The recess is deep enough and configured to receive door 4206.

Registration systems

As indicated above, the dialysis system and, in particular, the upper control unit, contains registration systems that interact with collector sections and, in particular, transparent collector sections or membranes embedded in the collector structure to record certain parameters or conditions, for example, costs, temperature, pressure, the presence of sodium, the presence of ammonia, pH levels, blood leakage, clogging or air bubbles. For example, registration of blood leakage, air bubbles and / or blockage is achieved by incorporating optical sensors into the dialysis apparatus that are attached to, and around, predefined collector areas. The manifold may include a plurality of tube support brackets that facilitate accurate placement of the piping system in optical sensors, for example Optek sensors, which are separately installed in the device when the collector is installed and the door is closed. The sensors provide a means for detecting blockage in the arterial line, blood leakage in the blood line after the dialyzer, and air detection in the venous blood line. The brackets restrict the pipeline on one side of the sensor, while the port port limits on the other side of the sensor. These optical sensors are horseshoe-shaped devices into which the pipe is inserted when the collector is installed. The pipeline support brackets provide support for the pipeline, so that all three of these sensors are loaded together with the collector, without additional effort from the user. Systems for recording flow, temperature, separation, central venous pressure, among other systems, are further described below.

Consumption

In one embodiment, the dialysis system comprises a non-invasive or non-contact type acoustic flowmeter that is capable of generating an acoustic signal directly in a controlled fluid without physical contact, thereby providing flow measurement with increased accuracy based on measurement of acoustic wave propagation time. It is also contemplated that the present flowmeter may be used with one of the above-described collectors for non-contact flow measurement in a collector.

43 is a circuit diagram illustrating an exemplary photoacoustic flow meter 4300. Liquid 4304, the flow rate of which is to be measured, is transferred through the liquid channel 4305, for example, a pipe, pipe or manifold segment, in the direction indicated by arrow 4306. The photoacoustic pulse flow meter 4300 contains a light emitting system 4310. In one embodiment, system 4310 further comprises an LED or solid state laser 4307 that is sinusoidally excited by signal source 4308. In another embodiment, a Q-switched ruby laser can be used instead of the 4310 system. Those skilled in the art will appreciate that any other suitable optical generation system known in the art can be used for this purpose.

An optical generation system 4310 projects the beam 4309 into the liquid 4304 through an optical aperture or optically transparent section formed in the wall of the channel 4305 (i.e., the collector segment). In one embodiment, the projected optical beam 4309 passes through the liquid 4304 in a direction perpendicular to the axis 4312 of the liquid channel 4305. The optically transparent section of the tube 4305 should be transparent to the specific wavelength of the optical source 4310. The wavelength of the optical source 4310 must be selected so that light was well absorbed by 4304, the flow rate of which the system must measure. It is also clear that when the present system 4300 is used with a collector, the optical generation system 4310 is preferably contained in a dialysis apparatus into which a disposable collector is loaded and aligned with the collector so that the generated optical beam 4309 passes through the transparent section of the collector.

When the optical beam 4309 enters the liquid 4304, the thermal energy associated with the optical beam is absorbed in the liquid. Heat absorption occurs in the direction of the beam 4309 and leads to thermal fluctuations in the liquid 4304. These thermal fluctuations look like localized heating of the liquid and cause thermal expansion of the liquid. As a result of this thermal expansion, an acoustic signal 4311 is generated. The nature of this signal, with respect to pressure changes in the liquid 4304, repeats the waveform generated in the signal source 4308 used to drive the optical signal generating element 4307. This pressure change propagates, both upstream and upstream with respect to the position of the optical beam 4309 in the channel 4305.

As known to those skilled in the art, acoustic signals received upstream and downstream by sensors 4313 and 4314, respectively, will be out of phase with each other. The magnitude of the phase difference between the acoustic signals received upstream and downstream is directly proportional to the flow rate. It is also obvious that when used in conjunction with a disposable collector, sensors 4313 and 4314 are located near the manifold pipeline or embedded in the manifold pipeline.

Accordingly, in one embodiment, the acoustic detectors T1 4313 and T2 4314 are located before and after, respectively, being at an equal distance from the optical beam 4309, so that d1 4313a and d2 4314a are equal. In another embodiment, placing 4313 and 4314 before and after does not imply an equal distance from 4309. Detectors T1 and T2 can be either pressure transducers or acoustic transducers, for example microphones. A microphone cartridge, such as the WM-55A103 manufactured by Panasonic Corporation, is suitable for this application.

Detectors T1 4313 and T2 4314 interrogate the fluid flow to detect acoustic signal 4311 at the points where the detectors T1 4313 and T2 4314 are located. The interrogation occurs acoustically when the changes in the (sound) pressure of the acoustic signal 4311 are transmitted through the walls of the pipe 4305 to sensors 4313 and 4314.

The first receiving amplifier 4315 is connected to the detector T1 4313, and the second receiving amplifier 4316 is connected to receive the output signal from the 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, respectively, through the elements 4319 and 4320 gain control. One implementation of phase-sensitive detectors 4317 and 4318 is known in the art as a “synchronous amplifier." After the signals are processed by amplifiers 4315, 4316 and phase-sensitive detectors 4317, 4318, the output signals 4317 and 4318 pass through low-pass filters 4321 and 4322 to eliminate high-frequency noise components or ripples remaining after the phase-sensitive detection process 4324 from the signals. The resulting output signals of filters 4321 and 4322 are stable signals representing a relative phase relative to the original signal of generator 4308, acoustic signals detected 4313 and 4314, respectively. Thus, the photoacoustic flowmeter provides an indication of the phase angle of the acoustic signals upstream and downstream, relative to the reference signal.

After processing and phase detection by phase-sensitive detector elements, phase angle signals upstream and downstream are fed to addition / subtraction unit 4323. The output of the addition / subtraction unit 4323 represents the phase difference between the acoustic signal received upstream by the acoustic detector T1 4313 and downstream by the acoustic detector T2 4314. This phase difference between these acoustic signals is directly proportional to the flow rate and, as is obvious to a person skilled in this field technique, can be used as the basis for calculating actual flow rate or flow rate changes. All means for calculating the flow rate include a processor and software algorithms for deriving the flow rate or flow rate changes from at least the phase difference data. Thus, the output of the addition / subtraction unit 4323 provides a measurement of fluid flow 4304.

Thus, as described above, in one embodiment, the voltage output signals of the first and second low-pass filters 4321 and 4322 are sampled and, in block 4323, subtracted to determine a phase difference signal indicating a flow rate of a channel 4305. One skilled in the art it is obvious that any other suitable means can be used to calculate the phase difference from the output signals of acoustic detectors. All such tools include a processor and hard-coded or soft-coded software algorithms for calculating the phase difference.

As mentioned previously, the signal generated by source 4308 plays the role of a reference signal for acoustic transducers T1 4313 and T2 4314 upstream and downstream. Fig. 44 depicts a reference signal 4400a generated by a source 4308 shown in Fig. 43. Fig. 44 depicts acoustic wave signals 4400b and 4400c, respectively, that have undergone signal processing at the outputs of amplifiers 4315 and 4316 with gain control shown in Fig. 43, respectively.

In one embodiment, a photoacoustic pulse flowmeter is used to contactlessly monitor fluid flow in a dialysis system, for example, a hemodialysis, hemofiltration and / or hemodiafiltration system known to those skilled in the art. The fluids whose flow rate is required to be measured during dialysis are mainly blood and dialysate, in blood and dialysate pipelines, respectively; however, it will be apparent to those skilled in the art that the flow rate of other fluids, such as an infusate or concentrate, can also be measured using the flow meter of the present invention. It will also be apparent to those skilled in the art that the flowmeter of the present invention is also capable of indicating the presence of fluid stagnation in a pipe / duct.

Thus, returning to FIG. 43, if the difference between the output signals of the low-pass filters 4321 and 4322 is zero, this means that there is no liquid flow. With regard to the dialysis system, this detection of fluid stagnation is very useful because it can indicate a serious problem, for example, the separation of an arterial / venous catheter connected to the patient.

In another embodiment, the flow in the manifold can be measured by a heat flow meter. Fig. 56 illustrates a fluid flow measuring device 5601 of the present invention installed with a collector 5602 in a dialysis unit 5610. As mentioned earlier, fluid flow channels or piping system 5603 are integrated into the collector 5603. The dialysis unit 5610 has a front door 5620 that can open for installation of a disposable collector 5602. Additionally, the front door 5620 is equipped with pins 5621, which, when the door 5620 is closed, can make contact with electrical points on the collector 5602 for reading providing information or providing electrical power.

The device 5601 thermal measurement of fluid flow additionally contains a number of contacts 5611, 5612 and 5613. From an operational point of view, when a fluid (eg, blood, dialysate or other liquids) flows during dialysis through a fluid flow channel 5603, it passes through the first contact 5611, embedded in a plastic duct. Contact 5611 forms an electrical contact with an electrical source, which in one embodiment is a pin 5621 on the front door 5620 of the apparatus. The electrical source or pin is controlled by a controller in the dialysis unit 5610. The electrical source communicates an electrical stimulus to contact 5611, which acts to microwave the contact using a sine wave method.

In one embodiment, the micro-heating process results in a temperature increase of from 0.1 to 1.0 degrees Celsius in the fluid where the measurement is performed. This is done by micro-heaters located on the first contact 5611, which generate heat when receiving an electrical stimulus. Microheaters for the thermal fluid flow measuring device of the present invention can be manufactured using any design suitable for use. In one embodiment, for example, the microheater is made of 10 turns of copper wire weighing 30 g, twisted around a pin located in the first contact position 5611.

With microheating of contact 5611, the resulting thermal energy acts to create a heat wave that propagates downstream after the first contact 5611. Many of the contacts, which are two in one embodiment, 5612 and 5613, are located after the first contact 5611 and used to measure the propagation time of the heat wave . Then, the measured phase of the wave is compared with the phase of the initial wave generated by the first contact 5611. The phase difference thus determined provides an indication of the flow rate.

Fig. 45 illustrates one embodiment of a flowmeter 4500a with probes that can be used to measure flow. Channel 4501a spans a volume 4502a through which a liquid, such as water or physiological saline (0.9 N) 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 length in the range of 10 mm to 100 mm (preferably 50 mm ), a channel area in the range of 3 mm ² to 65 mm ² (preferably 24 mm ² ) and / or a hydraulic diameter in the range of 1.5 mm to 7.22 mm (preferably 4.36 mm).

The direction of fluid flow is indicated by arrow 4504a. An excitation probe 4505a is located near the measuring probe 4506a. The relative distance of the probes is an important feature of the design, since the frequency of excitation at which the electrical stimulus is to be delivered by a pin or probe 4505a excitation depends on the separation between the probes 4505a and 4506a. In one embodiment, the field probe and the measurement probe are spaced less than 2 inches, preferably less than 0.8 inches, and more preferably approximately 0.6 inches, or approximately 15 mm, from each other. In this embodiment, only two contacts are required for excitation and measurement, with each contact having a contact surface 4507a. One skilled in the art will appreciate that, in this case, only two contact points are required, instead of three, as shown above with respect to the disposable collector and dialysis apparatus.

An excitation pin or probe 4505a is embedded in the channel 4501a and acts to communicate the current heat stimulus fluid (in the form of a heat wave), which is then recorded and measured by the measurement probe 4506a. In one embodiment, the body diameter of the pin or probe is from 0.03 inches to 0.15 inches (preferably 0.08 inches), the diameter of the upper contact surface is from 0.025 inches to 0.2 inches (preferably 0.125 inches) and is made of gold-plated brass or any other material having a density of about 8500 kg / m ^3, a thermal conductivity of about 1.09 W / mK and / or specific heat of about 0.38 J / kg · K.

In one embodiment, the bodies of the excitation pin or probe 4505a and the measuring pin or probe 4506a are formed in the manifold (so that the pin or probe is not in physical contact with the liquid and its upper contact area is open to one surface of the collector). The body of the pin or probe is centered in the cell, and fluid passes by it. The upper part of the pin is open, so the spring-loaded contact from the dashboard can create a thermal contact, which allows the transfer of thermal energy between the spring-loaded contact and the contact surface of the pin.

For example, FIG. 45 shows a side view of one embodiment of the heat flow meter 4500b of the present invention, where the contact surface 4507b is open, whereby the spring-loaded contact from the dashboard of the dialysis apparatus (shown in FIG. 56) can create a thermal contact, and heat energy can be exchanged. between the spring-loaded contact and the pin or probe 4505b excitation. Channel 4501b spans a volume 4502b through which fluid 4503b flows. The direction of fluid flow is indicated by arrow 4504b. An excitation probe 4505b is located near the measuring probe 4506b, each of which has a contact surface 4507b.

Fig. 45 further shows a heat flow meter 4500c from the end of the flow channel 4501c, which contains a volume 4502c through which fluid 4503c flows. Only the measuring probe 4506c and its contact surface 4507c are shown here. In one embodiment, the design of the measurement contact or pin 4506c is similar to the design of the excitation pin 4505b, and its top 4507c is also open. In one embodiment, the measuring pin surface 4507c is also designed as a spring loaded low heat contact. The excitation probes or pins 4505a, as well as the measurements 4506a, are made of a suitable material with high specific thermal and electrical conductivity, which in one embodiment is gold-plated brass.

In one embodiment, the spring-loaded low thermal mass contact in a device, such as a dialysis machine, allows temperature control using a heater and a thermistor. The temperature adjustment function then generates a cosine temperature wave in the probe, which reflects the temperature wave created in the spring-loaded contact. The characteristic of the resulting excitation signal of the excitation pin can be defined as:

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

The thermal response of the measuring pin can be characterized according to the following equation:

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

One representation of heat wave propagation is shown in FIG. According to Fig. 46, arrow 4601 represents the direction of fluid flow (and therefore the direction of propagation of the heat wave) in the fluid duct 4602 in the channel. The measuring contacts are represented by 4611, 4612 and 4613. Since the microheater is located near the first contact 4611, the heat wave starts at the first contact and then propagates to the second and third contacts 4612 and 4613, respectively, which are located after the first contact 4611. The distance between the second 4612 and third 4613 the contacts are designated as 4615.

46 further illustrates exemplary wave measurements 4620 at three pins 4611, 4612, and 4613. The heat wave generated at the first pin 4611 is represented by the first curve 4621. Provided that the flow is oriented from left to right, this heat wave will reach pin 4612 in the second position a little earlier than it reaches contact 4613 in the third position. The output signals at the second and third pins 4612 and 4613 are represented 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 passage through zero for each. The distance 4615 between the second 4612 and third 4613 contacts, divided by the time between the corresponding zero passes (also called the propagation time) is equal to the velocity of the fluid. Additionally, multiplying the calculated flow rate by the diameter of the liquid flow gives a volumetric flow rate.

The heat wave can be controlled using temperature sensors, which, in one embodiment, are designed based on thermistors, for example Cantherm, part number CWF4B153F3470, and are in physical contact with the contacts, located in the second and third positions. In one embodiment, contacts are monitored / measured using thermal measuring devices (which are in contact with two metal contacts) in the dialysis apparatus itself. This eliminates the need to integrate individual temperature measuring devices into the manifold. Obviously, in a preferred embodiment, the dialysis apparatus, or non-disposable device, contains a processor and memory, which stores a) the excitation frequency transmitted to the spring-loaded contact, which, after installing the disposable collector, physically communicates with the contact surface of the excitation probe, and b) the frequency of the temperature wave recorded by the measuring probe and transmitted, through the contact surface of the measuring probe, to the spring-loaded contact in the dialysis machine, or one-time Ore. The processor performs the calculations described herein to determine levels and temperature changes based on the above stored data. It is also obvious that this temperature information is then transmitted to the display driver, which provides a visual display or acoustic transmission of information through the user interface.

In one embodiment, the detection circuit checks the phase shift by mixing the drive signal and the measured signal, comparing and subjecting the low-pass filtering result to obtain phase shift information. In a more particular case, in one embodiment, phase detection is performed by multiplying the excitation frequency by the measured signal. The result is a signal with two components, one of which has a double frequency, and the other is a DC signal proportional to the phase shift between the reference excitation signal and the measured signal. This can be expressed according to the following equation:

phase detection: $$e_s{r}_r=\frac{E_s{R}_r}{2}[\sin (2\omega t+\theta )+\sin \theta ],$$

where e _s is the excitation signal, r _r is the measured signal, ωt is the excitation frequency, and θ is the phase.

As described above, the present invention relies on measuring the propagation time of a wave, and not on a thermal pulse. This method provides a significant advantage, since the thermal pulse disperses, which leads to uncertainty in determining the beginning of the pulse front and a significant increase in measurement noise. The waves also disperse, but the phase shifts of the sine wave, even after dispersion, remain more distinguishable. Thus, a sine wave measurement introduces less noise.

Another advantage of the present invention is the integration of a thermal flow sensor into a disposable collector. The plastic used in the collector plays the role of a heat insulator, which has a beneficial effect on measurements. As mentioned previously, in one embodiment, spring-loaded probes are used for a thermal flow measurement device, which makes it inexpensive and disposable.

The design of the device of the present invention is optimized in accordance with three parameters: a) thermal excitation (frequency of the input heat signal), b) expected flow rate (lower flow rate requires a different frequency than higher flow rate, since lower flow rate is accompanied by greater dispersion), and c ) the magnitude and extent of thermal dispersion. In one embodiment, to minimize noise and improve detection accuracy, a key parameter can be set constant, for example, constant phase shift, constant frequency, or constant flow area.

In one embodiment, the constant phase shift method is implemented using a phase-sensitive detector and a digitally controlled frequency generator. As described above, the propagation time determines the physical delay between the excitation probe and the measuring probe. At high costs, the physical delay is small, while at low costs the physical delay is large. Thus, in order to maintain a constant phase shift, the excitation frequency is controlled by feedback from a phase-sensitive detector. A feedback loop is included in the system, which allows you to dynamically adjust such important parameters as the excitation frequency, as a result of which the phase shift remains constant.

FIG. 53 is a diagram of one embodiment of the present invention where a constant phase shift operation mode is applied. Fluid 5303 flowing through channel 5301 passes by an excitation probe 5305 and a measurement probe 5307, which are separated by a distance 5309, as described above. In one embodiment, channel 5301 is part of a collector whose design allows it to be inserted into a dialysis machine and used there. When installed in a dialysis apparatus, the contact surface of the probe 5305 makes thermal contact with the driver 5325 of the heater, and the contact surface of the probe 5307 makes thermal contact with the temperature sensor 5330. The driver 5325 of the heater and the temperature sensor 5330 are in electrical contact with the circuit embodied in and / or integrated into the dialysis machine.

On the side of the excitation probe, the circuit comprises a reference signal source 5310, which transmits a signal having a phase θr to a summing device 5315, which also receives a signal θm from a low-pass filter, as described below. The two signals are summed, processed, or otherwise compared to obtain an output signal that is transmitted to a voltage-controlled generator 5320. The voltage-controlled generator 5320 outputs a signal Rp, where Rp = Kp sin (ωt), which is supplied to the heater driver 5325 and used to drive the heater driver 5325 to provide an excitation wave that is thermally transmitted to the probe 5305.

A heat wave propagates through channel 5301 as a function of fluid flow 5303. The measurement probe 5307 thermally transmits the recorded heat wave to a temperature sensor 5330. The recorded heat wave can be expressed as a function as follows: Es = Ks sin (ωt + θc).

As indicated above, the temperature sensor 5330 is in electrical contact with a circuit embodied in or integrated into the dialysis machine. The recorded heat wave (Es) is transmitted to a synchronous phase-sensitive detector using a multiplier component 5335, which multiplies the recorded heat wave (Es) by the input signal from the voltage-controlled generator 5320 (Rn, where Rn = Kn cos (ωt)), giving an output signal EsRn. The output signal EsRn (which can be expressed as EsRn = (KnKs / 2) [sin (2ωt + θc) + sin (θc)] is fed to amplifier 5340 and is amplified by constant K1. The amplified signal then passes to a low pass filter 5345, which receives an input signal from a voltage controlled oscillator 5320. An input from a voltage controlled oscillator 5320 is used to change the threshold or filter cutoff for low pass filter 5345. The output signal of the low-pass filter 5345 (θm, which can be expressed as a function of KnKsK1θc / 2) is a signal indicating a fluid flow rate that can be delivered by any means known to those skilled in the art and returned to said summing device 5315 for use in generating a reference the signal from the 5320 generator with voltage control.

On Fig shows a table that illustrates the range of the frequency of the excitation, which is dynamically adjusted to maintain a constant phase shift. According to Fig. 47, the determination process takes into account the values of various parameters, for example, flow rate 4701, which varies from 25 to 600 ml / min, and flow rate 4702, ranging from 17.36 mm / s to 416.67 mm / s. Using a value of 15 mm for the gap 4703 between the probes, the excitation frequency 4705 will vary from ~ 1.16 Hz at a flow rate of 25 ml / min to 27.78 Hz at a flow rate of 600 ml / min. The corresponding values of the propagation time and the measured amplitude are indicated in lines 4704 and 4706, respectively. Note that the measured amplitude is maintained at zero for a constant phase shift.

48 illustrates an output signal of a phase-sensitive detector constructed with respect to a time axis 4810. The various curves 4820 represent a series of output signals of a phase-sensitive detector for different flow rates. The graphs in Fig. 48 are plotted for the values given in the table in Fig. 47; accordingly, the flow rate ranges from 25 to 600 ml / min, and the corresponding excitation frequency varies from ~ 1.16 Hz to 27.78 Hz.

In another embodiment, a change in phase shift is acceptable while the excitation frequency remains constant. A constant excitation frequency is used in conjunction with a phase-sensitive detector, while the feedback mechanism is not used. Fig. 49 illustrates a table showing values of various parameters when the excitation frequency 4906 is maintained at a different frequency of 1.157 Hz. This value is applicable for 4901 flow rates ranging from 25 to 600 ml / min and 4902 flow rates ranging from 17.36 mm / s to 416.67 mm / s. When the gap 4903 between the probes is set to 15 mm, the corresponding values of the propagation time 4904 are from 0.0360 s (for a value of 1.000 harmonics 4905) to 0.864 s. The change in phase shift is reflected in the corresponding values of the measured amplitude indicated on line 4907. The measured amplitude 4907 is indicated on the final line. 50A and 50B illustrate two sets of output signals (for the flow rate indicated in FIG. 49) of a phase-sensitive detector constructed with respect to the time axis.

On Fig shows a diagram of one embodiment of the present invention, which applies the constant frequency mode. Fluid 5403 flowing through channel 5401 passes by an excitation probe 5405 and a measurement probe 5407, which are separated by a distance 5409, as described above. In one embodiment, channel 5401 is part of a collector, the design of which allows it to be inserted into a dialysis machine and used there. When installed in a dialysis apparatus, the contact surface of the probe 5405 makes thermal contact with the driver 5425 of the heater, and the contact surface of the probe 5407 makes thermal contact with the temperature sensor 5430. The driver 5425 of the heater and the temperature sensor 5430 are in electrical contact with the circuit embodied in and / or integrated into the dialysis machine.

On the side of the field probe, the circuit comprises a reference signal source 5410, such as a sine wave generator, that transmits a signal having a frequency (e.g., 1.17 Hz or so) to a heater driver 5425. The sine wave generator 5410 outputs a signal Rp, where Rp = Kp sin (ωt), which is supplied to the heater driver 5425 and used to drive the heater driver 5425 to provide an excitation wave that is thermally transmitted to the probe 5405. It is preferable that the excitation frequency be sufficiently low so that at low flow rates the phase shift is less than 80 degrees. Sine wave generator 5410 also outputs a signal Rn, where Rn = Kn cos (ωt), which is supplied to a multiplier 5435 and a low pass filter 5445, which is further described below.

A heat wave propagates through channel 5401 as a function of fluid flow 5403. A measurement probe 5407 thermally transmits a recorded heat wave to a temperature sensor 5430. The recorded heat wave can be expressed as a function as follows: Es = Ks sin (ωt + θc). The temperature sensor 5430 is in electrical contact with a circuit embodied in or integrated into the dialysis machine. The recorded heat wave (Es) is transmitted to a synchronous phase-sensitive detector using a multiplier component 5435, which multiplies the recorded heat wave (Es) by the input signal from the sinusoidal oscillator 5410 (Rn, where Rn = Kn cos (ωt)), giving the output signal EsRn . The output signal EsRn (which can be expressed as EsRn = (KnKs / 2) [sin (2ωt + θc) + sin (θc)] is fed to the amplifier 5440 and is amplified by the constant K1. The amplified signal then passes to a low pass filter 5445, which receives an input signal from a sinusoidal oscillator 5410. An input from a sinusoidal oscillator 5410 is used to change a threshold or cutoff filter for a low pass filter 5445. The output signal of the low pass filter 5445 (θm, which can be expressed as a function of KnKsK1θc / 2) is a signal indicating the flow rate of the liquid, which can be delivered by any means known to those skilled in the art. Obviously, the cutoff frequency of the low-pass filter is approximately 1/20 of the excitation frequency. The low-pass filter should attenuate the 2ωt signal by at least 80 dB.

On Fig shows the relative phase shifts of the signals generated in constant frequency mode at low flow rate and high flow rate. The excitation signal 5530 is generated at time 0. In the low flow scenario, the recorded signal 5520 is biased relative to the phase shift excitation signal 5530 θ _LF 5540, while, in the high flow scenario, the detected signal 5510 is biased relative to phase shift signal θ _hF θ ₅₅ 5550.

Regardless of whether the method uses a constant or variable phase shift method, the use of a phase shift as the basis of flow measurement has an advantage over the use of amplitude, since the amplitude is influenced by external factors, such as external temperature, which does not affect the phase shift.

In one embodiment, the non-contact heat meter of the present invention provides a measurement range from 20 ml / min to 600 ml / min. In addition to the factors listed previously, other factors that play an important role in ensuring optimal performance of a heat flow meter include flow characteristics, such as flow regime, maximum Reynolds number, and flow velocity; and physical characteristics of the flow cell, for example, height, width and length of the channel.

Fig. 51 contains a table showing an exemplary set of design parameters optimized so that the flow regime remains laminar and the Reynolds number 5109 is maintained below 2000, with a maximum flow rate of 5101 600 ml / min. To maintain the laminar flow regime, the channel size is optimized, including height 5102, width 5103, length 5104, area 5105, and hydraulic diameter 5106 of the channel. The Reynolds number 5109 is calculated taking into account the values of flow velocity 5107, hydraulic diameter 5106 and the properties of water 5108, for example, density, dynamic viscosity and kinematic viscosity.

In one embodiment, the flow cell is designed for turbulent flow instead of laminar flow. This design of the flow cell assumes a constant flow area, which, in turn, leads to an increase in the flow area around the probes (which decreases around the probes for laminar flow). With an increase in the area on the probes, the fluid velocity around the probes increases, and an increase in velocity causes the flow to enter a turbulent mode.

Fig. 52 is a table illustrating another set of exemplary design parameters for field probes and measurement probes, which in one embodiment have been dimensioned to provide a thermal time constant of 5205 less than 1 millisecond for optimal performance. Factors taken into account for this purpose are material, which in this case is brass, and its properties 5201, for example density, thermal conductivity and specific heat, as well as convection coefficient 5204. Accordingly, the size 5202 and the area 5203 of the open surface of the probes are determined.

Temperature recording

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

There are three main approaches using temperature recording, which can be integrated into the collector. It will be apparent to those skilled in the art that each approach allows variations that do not result in any significant change in the overall design of the reservoir. These approaches are discussed below.

Highly conductive liquid contact

In an approach of direct highly heat-conducting contact with a liquid, a metal disk is inserted into the wall of the collector, where a thermistor or any other suitable temperature sensor known in the prior art is in contact with the disk on the side of the dialysis apparatus, and with the liquid on the patient side. Thus, the temperature of the liquid can be controlled through a metal disk.

Traditionally, the temperature is controlled by placing the thermistor directly in the liquid stream. The use of a metal disk for temperature control in the present invention provides the advantage of reducing the risk of contamination and, therefore, eliminating the need for cleaning the thermistor.

It will be apparent to those skilled in the art that a metal disk of any suitable metal, such as 316 stainless steel, can be used for this purpose. Additionally, a thermistor of any manufacturer suitable for current use can be used. For example, you can use a BetaTherm thermistor manufactured with part number 10K 3A1A.

In one embodiment, the metal disc is intended to be used by one patient and is disposable, and the thermistor is part of the dialysis apparatus and is reusable.

Medium thermal fluid contact

The pressure transmitter membranes of the compact manifold are relatively thin and made of medium heat conductivity material. The most commonly used thickness is 0.040 ”and can vary from 0.005” to 0.050 ”. The thinner the material and the higher the thermal conductivity, the more accurately the pressure transducer membranes will transmit the temperature of the dialysis fluid to the pressure transducer installed inside the dialysis apparatus. Thanks to the design, they are in direct contact with the pressure transducer on the side of the device and with the fluid on the patient side. Placing a suitable temperature sensor inside the pressure transmitter allows you to control the temperature of the liquid. Certain pressure transducers known in the art already include a temperature sensor for correcting the transducer due to temperature drift. Such pressure transmitters with a sign of temperature registration can be used for the purposes of this application. An example of a combined pressure / temperature sensor is the MPT40 from Micron Instruments. The use of such a combination of sensors avoids direct contact with the liquid in which the measurements are made and reduces the number of components in the collector. This provides an alternative to the metal disk used in the previous approach.

Indirect optical temperature measurement

If the flow channel in the plastic wall of the collector has a limited thickness, for example, approximately 0.020 ”, then the plastic wall will be in thermal equilibrium with the liquid inside the collector. Under such conditions, non-contact optical temperature measurement can be performed outside the thinned wall, which makes it possible to determine the temperature of the liquid inside. An example is the Melexis Non-Contact Optical Temperature Sensor, part number MLX90614. The non-contact approach provides the advantage that it does not require additional parts in the manifold. The only requirement is the small wall thickness of the fluid channel. This approach provides low cost and, nevertheless, supports signs of safe operation for a single patient.

One possible implementation of an integrated conductivity sensor in the collector is a cell for measuring conductivity with electrical pins in contact with the dialysis solution. Technical details regarding an exemplary cell for measuring conductivity are shown in Fig. 57. According to Fig. 57, the conductivity measuring cell 5700 contains bias pins 5701 for passing a weak direct current through the fluid. The registration pins 5702 register the voltage in the liquid, and the magnitude of the recorded voltage depends on the conductivity and temperature of the liquid. The temperature is measured using a thermistor 5703 located near the cell 5700 for measuring conductivity. Alternatively, the temperature may be determined by one of the agents disclosed above. Knowing the values of the measured temperature and voltage on the recording pins 5702, it is possible to determine the conductivity of the liquid.

The current supplied through bias pins 5701 may be a direct current or alternating current signal and generally be in the frequency range of 50-100 kHz. In one embodiment, the applied current is of the order of 10 mA. The registration pins 5702 are generally deepened during the manufacture of the cell to measure conductivity, typically to a depth of ± 0.001 inches with cal solution in the cell. The accuracy of the 5703 thermistor is usually 0.5 ° C. The conductivity cell can be integrated into the channel of the dialysis solution of the compact collector by inserting or molding the conductive pins (displacement and registration pins) into the collector body in such a way as to ensure their contact with the dialysate, but not to allow the dialysate to leak from the collector.

Disconnect Detection

Embodiments of the disclosed dialysis system further include a device and method for detecting separation in an extracorporeal blood line used for any blood treatment treatment procedure. Examples of blood treatment treatments include hemodialysis, hemofiltration, ultrafiltration, or apheresis. Vascular access to establish an extracorporeal blood line is usually achieved using a transdermal needle or a Luer tip catheter. The device and method of separation uses a pressure pulse generated by the beating heart of the patient as an indicator of the intact connection of the needle or catheter with the vascular network. The pressure pulse generated by the patient’s heart is small; moreover, in the venous return line of the extracorporeal blood line. To detect a small pressure pulse, the present invention uses a cross-correlation methodology, where the reference heart signal is mutually correlated with the pressure pulse signal.

58 is a block diagram of a 5800 system for detecting a patient disconnected from an extracorporeal blood line, in accordance with an embodiment of the present invention. The 5800 system includes an input arterial blood flow 5802, a dialyzer 5804, a dialysate 5806, a patient pressure pulse transducer 5808, a patient heart signal generator 5815 as a reference signal, a disconnection monitor 5820, a 5825 controller, and a 5810 return venous blood line. In various embodiments of the present invention, blood taken from the patient passes through dialyzer 5804 through arterial blood line 5802, and purified blood from dialyzer 5804 is returned to the patient through venous blood line 5810. Contaminated minutes dialysate discharged from the dialyzer 5804, cleaned or regenerated dializatoprovode 5806 and pumped back into the dialyzer 5804. In various embodiments, the purified blood returns to the body of the patient through the transdermal needle or catheter with luer tip. Blood flow in the return venous blood line 5810 is usually 300-400 ml / min. Obviously, any suitable dialysate conduit can be installed.

Pressure transducer 5808 measures the pressure impulse of a patient undergoing a blood treatment treatment and substantially continuously transmits a pressure impulse to a disconnect monitor 5820. In one embodiment, transducer 5808 is an invasive or non-invasive venous pressure transducer located anywhere in the blood dialysis line (inlet arterial bloodline 5802 or reverse venous bloodline 5810). In another embodiment, transducer 5808 is an invasive or non-invasive venous pressure transducer located, in particular, in the blood dialysis line between the dialyzer 5804 and the patient, that is, in the return venous blood line 5810. Non-invasive air bubble detector and / or clamp valve (not shown ), optionally, are located between the 5808 transducer and the Luer connection to the patient. According to an embodiment of the present invention, the pressure transducer 5808 is located in close proximity to the needle or catheter inserted into the patient's body to provide vascular access corresponding to the return venous blood line 5810. The pressure transducer 5808 is located in close proximity to the needle or catheter to maintain fidelity waveforms. In other embodiments, a pressure transducer 5808 can be connected anywhere in the venous return duct 5810. According to an embodiment of the present invention, the pressure signal generated by the pressure transducer 5808 is an alternating current signal that is not an accurate measure of vascular pressure. Therefore, the pressure transducer 5808 is not a high precision transducer.

The reference signal generator 5815 essentially continuously transmits the patient's heart signal to the disconnect monitor 5820 as a reference signal. According to an embodiment of the present invention, the reference cardiac signal comes from a plethysmograph connected to the same part of the body (for example, the arm) to which a needle or catheter is attached to supply the patient with treated blood. In another embodiment of the present invention, a reference heart signal is provided from a finger pulse / oximeter sensor. In various other embodiments of the present invention, a reference heart signal can be obtained through an electrocardiogram signal (ECG), a real-time blood pressure signal, a stethoscope, a blood pressure signal from a blood sampling line, a pulse / oximeter sensor signal, a variable area plethysmograph signal, transmission signals and / or a reflective plethysmograph, acoustic heart signals, a pulse on the wrist, or from any other source of heart signal known to those skilled in the art.

Disconnection monitor 5820 detects a violation in the venous return conduit 5810 due to disconnection of the needle or catheter from the patient’s body undergoing blood treatment. To detect a disconnect, the 5820 monitor processes a patient pressure transducer and cardiac reference signals. It will be apparent to those skilled in the art that such a disconnection may be caused by pulling the needle or catheter out of the patient’s body for any reason, for example, due to a sudden movement of the patient. The disconnect monitor 5808 is described in detail with reference to FIG. The 5825 controller is any microprocessor known to those skilled in the art. The function of the 5825 controller is to receive processed inputs from the 5820 monitor and, accordingly, initiate appropriate actions, if necessary.

It will be apparent to those skilled in the art that the pressure transducer and reference signals are transmitted to the disconnect monitor 5820 via transmitters included in the reference signal generator and pressure transducer. The transmitter may provide wired or wireless communication with a suitable receiver. Similarly, data from the disconnect monitor 5820 is transmitted to the 5825 controller via a wired or wireless connection. In one embodiment, such a signal transmission is provided using an appropriate wired or wireless public and / or private network, for example, LAN, WAN, MAN, Bluetooth and / or the Internet. Also in one embodiment, the disconnect monitor 5820 and the controller 5825 are located close to each other and the pressure transducer 5808 and the heart reference generator 5815. In an alternative embodiment, the disconnect monitor 5820 and / or controller 5825 are located at a distance from each other and / or from other components of the 5800 system.

59 is a block diagram illustrating a device 5900 for detecting disconnection in a return venous blood line, in accordance with an embodiment of the present invention. The disconnect monitor 5900 comprises a pressure transducer receiver 5902, a reference signal receiver 5904, and a cross-correlation processor 5906. Transmitter receiver 5902 and reference signal receiver 5904 receive input signals from pressure transducer 5808 and cardiac reference signal generator 5815, respectively, shown in FIG. 58.

The signal of the pressure pulse received by the receiver 5902 of the pressure transducer and the reference heart signal received by the receiver 5904 of the reference signal are stored in local memory and additionally fed to the cross-correlation processor 5906, which, in turn, calculates the correlation between the two signals. The output of processor 5906 is provided to a controller 5825 shown in FIG. 58. If the output signal generated by the cross-correlation processor 5906 indicates a correlation between the two input signals, this means that the return venous blood line is not damaged. If the output signal generated by the cross-correlation processor 5906 does not indicate a correlation between the two input signals, this means that the return venous blood line is broken due to the pulling out of the needle or catheter, and the controller 5825 shown in Fig. 58 initiates appropriate actions, for example, generating a warning signal and / or complete or partial shutdown of the dialysis system.

Those skilled in the art should note that the present invention provides for the use of any cross-correlation processor that couples, matches, or otherwise creates a measurable, quantifiable and / or predictable relationship between the pressure transmitter signal and the reference signal. In one embodiment of the present invention, cross-correlation is performed using a synchronous amplifier, for example SR810 Lock-In Amplifier manufactured by Stanford Research Systems, California. Various known methods for detecting cross-correlation of systems with a very low signal to noise ratio, and cardiac signals may be included in the cross-correlation processor 5906.

In various embodiments of the present invention, the cross-correlation function calculated by the cross-correlation processor 5906 is used to measure the degree of similarity between two input signals, i.e. reference heart signal and pressure pulse signal. The calculation of the cross-correlation function contains the calculation of the sum of the products of the corresponding pairs of points of two input signals in the specified time interval or window. The calculation also takes into account any potential phase differences between the two input signals due to the inclusion of a lead or lag term. The mathematical formula corresponding to the cross-correlation function has the form:

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

Fig. 60 is a flowchart illustrating exemplary steps of a method for detecting a patient disconnected from an extracorporeal blood line, in accordance with an embodiment of the present invention. From an operational point of view, the dialysis system software, which contains many instructions and runs on the processor, prompts the patient to first attach a cardiac signal generator (for example, a finger heart rate monitor / oximeter) to receive a 6005 reference signal. In this case, the patient may or may not be connected to the dialysis system. After or simultaneously with the capture of the cardiac reference signal, the dialysis system software, which contains many instructions and runs on the processor, prompts the patient to connect to the 5800 system shown in FIG. 58, which also results in a 6010 signal from the patient’s pressure pulse transducer. The cross-correlation processor then attempts to correlate the 6015 reference signal and the converter signals. If at startup it is not possible to achieve correlation, in one embodiment, the patient is prompted to turn off all or some of the components 6020, or, in another embodiment, the 5800 system controller 5825 shown in FIG. 58 does this automatically to reduce noise. For example, shutting down dialysis system pumps can reduce noise and facilitate the capture and correlation of two signals. In another embodiment, an attempt to establish cross-correlation is made before the inclusion of system components generating noise, such as pumps. Thus, an attempt is made to establish a correlation before the system is fully launched. In one embodiment, if no correlation is established, a warning signal is triggered indicating that the patient’s dialysis system may have an abnormality.

However, if a correlation is obtained, then this correlation is essentially continuously monitored 6025, if there is any deviation in this correlation, a warning signal 6030 is triggered indicating a possible leak or, optionally, the system shuts down (fully or partially) and a new attempt is made establishing a correlated signal. In one embodiment, if the nature of the correlation changes or deviates beyond or within a predetermined threshold, some system components, such as pumps, are turned off and the cross-correlation processor attempts to re-establish the correlation. If the correlation cannot be reestablished, a warning signal is triggered. In another embodiment, if the nature of the correlation changes or deviates beyond the range or range of a predetermined threshold, certain system components, such as pumps, are turned off and a warning signal is triggered immediately, before any additional attempt to re-establish the correlation.

This approach to disconnect control provides some notable improvements over the prior art. Firstly, unlike the prior art, the present invention makes it possible to distinguish between cases when the needle is partially pulled out and when it is removed and pulled out at a certain distance from the insertion point. Secondly, the present invention does not need any additional device located at the injection site, for example, a wet pad. Thirdly, due to the mutual correlation of the patient’s own cardiac signal, false negative results are largely suppressed. Fourth, the combination of pressure pulse recording and cross-correlation makes the present invention unique and capable of detecting signals with a low signal to noise ratio. Fifth, continuous monitoring of the cross-correlation status allows the system to detect small signal deviations, which, in principle, may indicate a disconnection. Thus, the present invention provides a device and method for detecting a disconnection in an extracorporeal blood line used for any blood treatment treatment procedure.

Central venous pressure control

The dialysis system embodiments disclosed herein further include methods and systems for monitoring and adjusting the ultrafiltration (UV) rate so that the volume of fluid in the dialysed / ultrafiltered patient remains within the desired range. This invention provides for the integration of central venous pressure (CVP) control into a dialysis system and uses CVP measurements to adjust the rate of ultrafiltration (UV). CVP feedback data helps prevent excessive removal of fluids as a safety measure and provides a means of titrating UV speed to improve the healing effect.

Measuring CVP involves measuring the average pressure present in the central venous line used for dialysis, thus combining the measurement of CVP with dialysis. To measure CVP, an appropriate catheter must be inserted into the patient’s body so that the tip of the catheter is located intrathoracically. Fig. 61 depicts an exemplary position of a central venous catheter for hemofiltration and CVP measurement. 61, a central venous catheter (CVC) 6110 is used to provide vascular access for UV. In this particular embodiment, the insertion site 6120 selected for the CVC 6110 is located under the collarbone 6130, on the subclavian vein 6140. It will be apparent to one skilled in the art that any other large vein in the patient’s body can be selected as an alternative insertion site for the patient, leaving its tip is intrathoracic. CVC 6110 passes through the subcutaneous tunnel 6150, and is secured with a clamp 6160 and a standard Luer tip 6170. The pressure at the CVC tip at exit location 6180 is equal to the central venous pressure.

In one embodiment of the present invention, CVC 6110 is used to access blood during hemofiltration, and central venous pressure can be measured using sensors within the hemofiltration apparatus. In this case, no additional equipment is required to measure the CVP. In another embodiment, a double-lumen CVC is used for hemofiltration. In this case, the near lumen can be used to draw blood, and the far lumen (on the tip) can be used to return blood. A clearance or port can provide a measurement of the CVP. In both cases, when the CVC is used to access the blood, the system of the present invention provides that, prior to the production of the CVP measurement, the blood flow is momentarily stopped to provide an accurate pressure measurement. Thus, in one embodiment, the present invention provides for the integration into conventional dialysis machines of software for stopping blood flow through a device based on a predetermined frequency of the CVP measurement.

62 is a block diagram illustrating a dialysis control system of the present invention. 62, a user interface 6210 is provided that receives inputs from a user (clinician) indicating a preferred CVP measurement frequency and a preferred range of CVP values. These inputs go to a central dialysis controller 6220. The central dialysis controller 6220 is a programmable system that can be used to adjust the control of the CVP and the hemodialysis / ultrafiltration rate based on the monitored CVP. Depending on the frequency of the CVP measurement determined by the user, the central dialysis controller 6220 transmits a signal to the blood pump in the dialysis system 6230 to stop blood flow whenever it is necessary to register the CVP measurement. After that, the HPC sensor in the dialysis system 6230 takes the measurement and transfers it to the central dialysis controller 6220, which can transmit it to the user interface 6210 for display. Upon completion of the CVP measurement, the central dialysis controller 6220 transmits another signal to the dialysis system 6230, ordering the resumption of blood flow. The central dialysis controller 6220 also monitors the measured CVP values to determine if they are in the range specified by the user. A decrease in CVP below a given range will indicate hypovolemia. In this case, the central dialysis controller 6220 stops the ultrafiltration process, which prevents the removal of additional fluid until the CVP is restored to the desired range. In one embodiment, the central dialysis controller 6220 titrates the removal of ultrafiltrate to a range of 2-6 mmHg. Art., which allows you to maintain the CVP in the desired range.

The CVP control and UV adjustment system provides a wide range of CVP measurement systems combined with traditional dialysis machines. CVP measurement can be done in a variety of ways. In one embodiment, the CVP can be measured using a sensor located on the tip of an appropriate catheter. In another embodiment, the CVP can be measured using a special pressure transducer located at a distance from the catheter, the transducer being held flush with the heart. 63 is an exemplary illustration of a last embodiment. 63 shows a catheter 6310 used to access blood. A catheter 6310 is located in the central vena cava 6320. A 6330 pressure transducer measures central venous pressure at heart level. In this case, the measurement of CVP is used to control the hemofiltration rate in the same way as when using CVC.

In another embodiment, the CVP is measured using a remote sensor inside the hemofiltration apparatus. On Fig illustrates an exemplary bloodline 6400 with the provision of measurement of CVP. When the patient’s blood enters line 6400, the anticoagulant is injected into the blood using a syringe 6401 to prevent coagulation. A PBIP pressure sensor 6410 is provided, which is used to measure central venous pressure. A 6420 blood pump pumps blood from the patient into the 6430 dialyzer. Two other pressure sensors PBI 6411 and PBO 6412 are provided at the inlet and outlet of the 6430 dialyzer, respectively. The PBI 6411 and PBO 6412 pressure sensors help monitor and maintain fluid pressure at the observation points in the system. hemodialysis. The dialyzer is also equipped with a pair of bypass valves B 6413 and A 6414, which ensure that the fluid flows in the desired direction in a closed dialysate line. The user can remove air on port 6417 if the 6418 sensor detects air bubbles. Up to port 6417 air elimination provided sensor 6416 blood temperature. The 6418 AIL / PAD Sensor and 6419 Clamp Valve are used in the piping to ensure a smooth and unhindered flow of clean blood to the patient. A 6421 refill kit is pre-attached to the hemodialysis system, which helps prepare the system before it is used for dialysis.

To perform CVP measurements, the blood flow in line 6400 is stopped by stopping the 6420 blood pump. The pressure in the catheter used to access the blood (not shown) will be equalized, and the pressure measured on the PBIP pressure sensor 6410 in the hemofiltration apparatus, the pressure at the tip of the catheter will be equal. This measured pressure (CVP) is used to adjust the rate of ultrafiltration and the volume of fluid removed from the patient's body.

Thus, in terms of operation, the system of the present invention modifies the traditional dialysis system so that ultrafiltration is carried out at a speed predetermined by the doctor. The blood flow stops periodically and the mean CVP is measured using one of the various measurement methods described above. In one embodiment, a safe mode is provided in which if the CVP falls below a predetermined limit, the hemofiltration is interrupted and a warning signal is given.

In another application, a hypervolemic patient, such as a patient with congestive heart failure (CHF), can be prescribed ultrafiltration to remove fluids. It is known in the art that although the ultrafiltration process removes fluid from the blood, the fluid to be removed is located in the interstitial spaces. Additionally, the flow rate of fluid from interstitial spaces into the blood is unknown. Without the system of the present invention, the doctor can only speculate what rate of removal of interstitial fluid will balance the removal of fluid from the bloodstream by the flow of fluid back into the blood from the interstitial space, and sets the dialysis apparatus at that speed. In such a scenario, constant monitoring by the doctor is required to ensure that the rate of fluid removal does not lead to excessive or insufficient hydration of the patient. With the system of the present invention, a physician can pre-set the total amount of fluid that he wishes to remove, usually calculated based on the patient’s weight and the minimum acceptable mean CVP. Then the system removes the fluid at maximum speed, which automatically maintains the desired CVP. Thus, the system of the present invention automatically balances the rate of fluid removal with the rate of fluid flow from interstitial spaces into the blood.

Obviously, the levels of normal CVP are from 2 to 6 mm Hg. Art. Increased CVP indicates rehydration, while decreased CVP indicates hypovolemia. Using the present invention, a patient can begin an ultrafiltration session with a CVP higher than normal, for example 7-8 mmHg. Art., and end the session with the final target CVP 3 mm RT. Art., for example, in a 6-hour treatment session. However, if in the middle of the treatment session, the CVP falls by more than 50% of the desired reduction, while the removed fluid reaches only 50% of the final removal goal, the system can be reprogrammed to lower the target value for liquid removal or reduce the rate of liquid removal. Other actions can be taken based on more complex algorithms. The end result is that hypovolemia can be avoided by controlling the speed and actual value of the CVP. Obviously, this approach can also be useful in controlling fluid removal rates not only during hemofiltration, but also for all types of artificial kidney treatment.

Controlling and maintaining volume accuracy

The dialysis system embodiments disclosed herein further include methods and systems for maintaining volumetric accuracy of physiological saline and fluid output in the hemodialysis system. In one embodiment, the method comprises changing the pumps used on the saline side and the outlet side, whereby an equal amount of liquid is pumped on each side. The pump change system of the present invention provides an accurate means for maintaining fluid volumes during the dialysis procedure, and can be inexpensively implemented for reusable as well as disposable devices.

Fig. 65 illustrates an exemplary pump change manifold used in one embodiment. Hemofiltration pump change pipeline 6500 contains two pumps, pump A 6545 and pump B 6555. These two pumps are in fluid communication with physiological saline piping R 6560 and O 6570 outlet piping. Fluid communication is facilitated by two pairs of two-way valves 6505 and 6507. For piping R 6560 physiological saline, a source of physiological saline solution 6510 supplies liquid through a restrictor 6517 to a pair of two-way valves 6505. After that, depending on which of the two valves in pair 6505 is open, physiological the solution is injected either by pump A 6545 or pump B 6555 into the second set of two-way valves 6507. This set of two-way valves 6507 channels the saline into the saline solution line R 6560, which is in fluid communication with the outlet 6542 of the dialyzer 6540. In the present embodiment, the output 6542 of the dialyzer 6540 is associated with the configuration of the post-dialysis infusion. In another configuration known in the art, on the contrary, communication is with the dialyzer input 6544. One skilled in the art will recognize that any configuration can be used without affecting the scope of the invention.

A pair of two-way valves 6505 can be made with the possibility of alternating opening, due to which any of the following channels of fluid communication can be installed:

between the outlet pipe O 6570 and pump A 6545;

between the pipeline R 6560 saline and pump B 6555;

between the pipeline R 6560 saline and pump A 6545; and,

between the outlet pipe O 6570 and pump B 6555.

System 6500 also includes two pressure sensors 6515 and 6516. Sensor 6516 is located on the outlet pipe O 6570, and sensor 6515 is located near the source of saline solution 6510. Pressure sensors 6515 and 6516 are used to monitor pressure. Pressure data from these sensors is sent to the active restrictor 6517 through a differential amplifier 6525. Depending on the pressure measurements, the restrictor 6517 restricts the flow of saline in different ways as necessary.

During dialysis, additional fluid can be removed from the patient, if necessary, in the form of an ultrafiltrate (UV). For this purpose, a 6535 UV pump is provided, which pumps UV into a bag or drain 6530. Since UV liquid is removed to the point of pressure measurement in the outlet section of the O 6570 pipeline, volumetric accuracy is maintained regardless of the volume of UV removed.

From an operational point of view, volumetric accuracy in the hemodialysis system of the present invention is achieved by changing the pumps 6545 and 6555 used on the saline side and on the output side, so that after an even number of shifts, the same amount of fluid is pumped at each point. Two pairs of two-way valves 6505 and 6507 facilitate the use of each of the pumps alternately with the pipeline R 6560 saline solution and the output pipe O 6570.

In one embodiment, the pumps used are peristaltic pumps. It will be apparent to those skilled in the art that other types of pumps can also be used, since volume balance in renal dialysis is achieved using the pump change method and is independent of the type of pump. In one embodiment, pump A 6545 delivers more fluid per unit time than pump B 6555. Thus, this results in more physiological saline being pumped at any given time than the outlet fluid.

It will be apparent to those skilled in the art that pumps that include a disposable element may have different capacities because the volumes through the disposable elements are not equal, even if they are of the same size and type. For example, the volumes of two disposable syringes of nominally the same size inserted into two syringe pump assemblies will not be exactly the same. It will also be apparent to those skilled in the art that two pumps that do not have disposable elements can usually be configured so that there is no difference in performance between them. Examples of pumps using disposable elements that can be implemented according to 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 physiological saline and effluent, pumps 6545 and 6555 exchange every T minutes. At the end of the first T-minute interval, due to the specific characteristics of the pumps, pump A 6545 will deliver a larger volume than pump B 6555. The volume of fluid delivered by pump A 6545 is denoted by 'Q'. Thus, if during the first discharge interval 'T', saline is sent through pump A 6545, and the outlet fluid is directed through pump B 6555, then at the end of time interval T, in the pipeline R 6560 saline will be pumped to 'Q' more saline solution than the outlet fluid in the pipeline O 6570.

After that, pumps A 6545 and B 6555 are exchanged at the next time interval, and the outlet liquid in pipeline O 6570 is pumped by pump A 6545, and physiological saline in pipeline R 6560 is pumped by pump B 6555. In this interval, R 6560 will be pumped to 'Q 'less saline than the output fluid in O 6570. Thus, at the end of the second interval (and at the end of an even number of shifts), the difference in the volumes pumped during each interval will be equal to: QQ = 0. Thus, the total volume difference is zero after an even number of shifts, which allows achieving a volume balance between the injected physiological saline and the output fluid returning from the patient through the dialyzer. It will be apparent to those skilled in the art that there may be a minimal change in flow rate through the pump over time and, therefore, the volume delivered per unit time. In this case, the total volume difference may not be exactly zero, but very close to zero.

The volume pumped by the peristaltic pump depends on the pressure. The pump head is a function of the piping section, not the pump, and is systematically different in the R 6560 saline piping from the O 6570 outlet piping. Thus, the heads tested by pump A 6545 and pump B 6555 need to be aligned.

In one embodiment, the pressures are equalized by modulating a restrictor 6517 in the inlet pipe from the saline source 6510. The modulation of the limiter is achieved based on the output signal of a differential amplifier 6525, which calculates the pressure drops between the pressure values measured by the pressure sensors 6515 and 6516 located between the pumps 6545 and 6555. The amount of compensation required will depend on how much the pump is affected by the pressure in the R 6560 pipe saline solution and the output pipe O 6570. The pressure in the pipe O 6570 is usually negative. The pressure in the pipeline R 6560 will be positive if the packages of physiological saline (source) 6510 rise above the level of the pumps, and negative if the packages are vertically located below the level of the pumps. For pumps using heavy duty tubular pump segments, the differences can be relatively small.

As mentioned, the pressures are equalized by measuring the pressure in the sections of the pipeline R 6560 and O 6570, transferring these pressures as an input signal to the differential amplifier 6525 and modulating the inflow from the saline solution package 6510 with a variable restrictor 6517 in the section of the pipeline R 6560, which is regulated by the output signal differential amplifier 6525. Since the pressure is a function of the pipeline section, and not the pump, it is therefore necessary to adjust the average difference between the pressure of the two sections of the pipeline in eotregulirovannom state. Unregulated pressures can be measured initially and at desired intervals during operation, briefly disabling the adjustment. This recalibration does not require a discharge stop.

In one embodiment, pump heads may vary from zero to over several hundred mmHg. Art., depending on the dialyzer used, the height of the physiological saline relative to the dialysis apparatus and the dialysate flow rate setting. For example, for a dialysate flow of 200 ml / min and physiological saline packets suspended 5-10 inches above the dialysis apparatus, the pressure drops are from 10 mmHg. Art. In the general case, when the pressure in the pipeline R 6560 of physiological saline is higher than the pressure in the pipeline O 6570, a flow restrictor 6517 will restrict the flow from the source 6510 of physiological saline to compensate for the differential pressure.

For a dialysis system where a closed dialysate conduit is used, where the dialysis fluid is constantly circulating through a sorbent cartridge, Fig. 66 represents a pump alternating change conduit. Hemofiltration pump change line 6600 contains two pumps, pump A 6645 and pump B 6655. These two pumps are in fluid communication with the return line R 6660 and the sorbent line S 6670. The liquid connection is facilitated by two pairs of two-way valves 6605 and 6607. For the return line R 6660, reservoir fluid source 6610 supplies fluid through restrictor 6617 to a pair of two-way valves 6605. After that, depending on which of the two valves in pair 6605 is open, saline is pumped either by pump A 6645 or pump catfish B 6655 into the second set of two-way valves 6607. This set of two-way valves 6607 channels the liquid through the sorbent cartridge 6608 and through the reservoir 6610 to the return pipe R 6660, which is in fluid communication with the input port 6642 of the dialyzer 6640.

A pair of two-way valves 6605 can be made with the possibility of alternating opening, due to which any of the following channels of fluid communication can be installed:

between the sorbent line S 6670 and pump A 6645;

between return pipe R 6660 and pump B 6655;

between return pipe R 6660 and pump A 6645; and

between the sorbent line S 6670 and pump B 6655.

The 6600 system also contains two pressure sensors 6615 and 6616. The sensor 6616 is located on the sorbent line S 6670, and the sensor 6615 is located near the source of liquid 6610 of the tank. Pressure sensors 6615 and 6616 are used for pressure monitoring. The pressure data from these sensors is supplied to the active restrictor 6617 through a differential amplifier 6625. Depending on the pressure measurements, the restrictor 6617 differently restricts the fluid flow of the tank as needed.

As in the previous embodiment, this embodiment provides for providing a UV (ultrafiltrate) pump 6635, which allows, if necessary, to remove additional fluid in the form of (UV) from the patient's body during dialysis. The 6635 UV pump pumps the ultrafiltrate into a bag or runoff 6630. Since the UV fluid is removed to the point of pressure measurement in the S 6670 sorbent line, volumetric accuracy is maintained regardless of the volume of UV removed.

From an operational point of view, volumetric accuracy in the hemodialysis system of the present invention is achieved by changing the pumps 6645 and 6655 used on the liquid return side and on the sorbent side, therefore, after an even number of shifts, the same amount of liquid is pumped at each point. Two pairs of two-way valves 6605 and 6607 facilitate the use of each of the pumps alternately with the return pipe R 6660 and the sorbent pipe S 6670.

In one embodiment, the pumps used are peristaltic pumps. It will be apparent to those skilled in the art that other types of pumps can also be used, since volume balance in renal dialysis is achieved using the pump change method and is independent of the type of pump. In one embodiment, pump A 6645 delivers more fluid per unit time than pump B 6655. Thus, this leads to pumping more return fluid than the liquid sorbent at any given time period.

It will be apparent to those skilled in the art that pumps that include a disposable element may have different capacities because the volumes through the disposable elements are not equal, even if they are of the same size and type. It will also be apparent to those skilled in the art that two pumps that do not have disposable elements can usually be configured so that there is no difference in performance between them.

To achieve a volume balance between the return liquid and the liquid sorbent, pumps 6645 and 6655 exchange every T minutes. At the end of the first T-minute interval, due to the specific characteristics of the pumps, pump A 6645 will deliver a larger volume than pump B 6655. The volume of fluid delivered by pump A 6645 is denoted by 'Q'. Thus, if during the first discharge interval 'T', the tank liquid is directed through pump A 6645 and the liquid sorbent is directed through pump B 6655, then at the end of time interval T, in the return pipe R 6660 more reservoir liquid will be pumped to 'Q' than the liquid sorbent in pipeline S 6670. After that, the pumps A 6645 and B 6655 are exchanged at the next time interval, and the liquid sorbent in pipeline S 6670 is pumped by pump A 6645, and the return liquid in pipeline R 6660 is pumped by pump B 6655. In this interval in R 6660 will be pumped 'Q' is less than the reservoir liquid than the liquid sorbent in S 6670. Thus, at the end of the second interval (and at the end of an even number of shifts), the difference in the volumes pumped during each interval will be: Q-Q = 0. Thus, the total volume difference is zero after an even number of shifts, which allows achieving a volume balance between the injected return fluid and the liquid sorbent returning from the patient through the dialyzer. Again, since there may be some, usually small, change in the flow rate through the pump over time, leading to a change in the volume delivered per unit time, the resulting difference in volumes may not always be exactly zero, but very close to zero.

As is true for the embodiment shown in FIG. 65, the volume pumped by the peristaltic pump according to the embodiment illustrated in FIG. 66 is pressure dependent. Additionally, since the pump head is a function of the portion of the pipeline, not the pump, and is systematically different in the return pipe R 6660 from the sorbent pipe S 6670, it is necessary to align the heads tested by pump A 6645 and pump B 6655.

In one embodiment, the pressures are equalized by modulating the restrictor 6617 on the inlet pipe from the reservoir fluid source 6610. The modulation of the limiter is achieved in the same way as in the embodiment shown in Fig. 65 and is based on the output of the differential amplifier 6625. The differential amplifier 6625 calculates the pressure drops between the pressure values measured by the pressure sensors 6615 and 6616 located between the pumps 6645 and 6655. The amount of compensation required will depend on how much the pump is affected by the pressure in the return pipe R 6660 and the sorbent pipe S 6670. The pressure in the pipe S 6670 is usually negative flaxseed. The pressure in the pipe R 6660 will be positive if the reservoir 6610 rises above the level of the pumps, and negative if the reservoir is vertically located below the level of the pumps. For pumps using heavy duty tubular pump segments, the differences can be relatively small.

As mentioned, the pressures are equalized by measuring the pressure in sections of the pipeline R 6660 and S 6670, transferring these pressures as an input signal to the differential amplifier 6625 and modulating the inflow from the reservoir 6610 with a variable restrictor 6617 in the section of the pipeline R 6660, which is regulated by the output signal of the differential amplifier 6625. Since the pressure is a function of the pipeline section, and not the pump, it is therefore necessary to adjust the average difference between the pressure of the two sections of the pipeline in an unregulated thawing. Unregulated pressures can be measured initially and at desired intervals during operation, briefly disabling the adjustment. This recalibration does not require a discharge stop.

In one embodiment, pump heads may vary from zero to over several hundred mmHg. Art., depending on the dialyzer used, the height of the tank relative to the dialysis apparatus and the dialysate flow rate setting. For example, pressure drops range from 10 mm Hg. Art. for a dialysate flow of 200 ml / min and with a reservoir located 5-10 inches above the dialysis unit pumps. When the pressure in conduit R (return) 6660 is higher than the pressure in conduit S 6670 (from the dialyzer), flow restrictor 6617 restricts flow from reservoir 6610 for compensation.

In any of the configurations in Fig. 65 and Fig. 66, the outflow to the dialysate segment may sometimes increase (O 6570 or S 6670, respectively) due to the increased pressure drop across the membrane (TMP) of the dialyzer. This may occur, for example, due to restriction of the outflow of the dialyzer (6540 or 6640, respectively). In this case, there may be a possibility that the restrictor (6517 or 6617, respectively) is not able to open sufficiently for adjustment, for example, if the saline source 6510 or the reservoir 6610 is located below the level of the pumps. In contrast, a booster pump can be installed in the pipeline after a saline source 6510 or reservoir 6610. The booster pump can be configured to automatically turn on when the differential amplifier (6525 or 6625, respectively) and / or limiter (6517 or 6617 , respectively) is not able to control the system.

Since a time gap is created during the pump shift, the time interval between shifts must be calculated. This calculation is a function of the maximum allowable difference in the amount of fluid injected, which is determined by two functions at any given time. However, the calculation should compensate for the pressure differences presented to the pumps for the fluid coming from the saline containers and returning from the patient through the dialyzer.

The frequency with which the pumps change depends on the maximum allowable increase or decrease in the volume of fluid in the patient’s body during the dialysis process for any given interval T. For example, if the allowable net gain or loss is 200 ml and saline is injected at a rate of 200 ml / min, then the pump change frequency for different levels of differences in the performance of the two pumps is shown in table 6700 in Fig. 67.

In the following description, components are presented according to the embodiment shown in FIG. 65, but it also applies to the embodiment illustrated in FIG. 67, the first row 6701 of the table illustrates that when the percentage difference in capacities of the two pumps, pump A 6545 and pump B 6555, is 1%, which is equivalent to a difference in liquid volumes of 2 ml (for an allowable net gain or loss of 200 ml), then changing the pumps with a time interval of 200 ml / 2 ml = 100 minutes will provide a zero volume difference. Similarly, for a productivity difference of 2%, changing the pumps at intervals of 200 ml / 4 ml = 50 minutes will provide volume balance, etc. This is illustrated in the following rows of table 6700.

Even in the case of a significantly stricter restriction on the maximum volume of fluid injected into or removed from the patient, for example ± 30 ml as opposed to ± 200 ml in the above example, the shift interval for the case when the productivity difference is 5% will be 30 ml / 10 ml = 3 minutes. Since it is only necessary to switch the two-way valves (indicated by 6505 in Fig. 65) and start and stop the pumps is not required to change the pumps, even a short interval of 3 minutes (or shorter) can be implemented in practice.

A more frequent change of pumps can also offset any discrepancy in pumping capacity. Since in the system of the present invention, the tubes of both pumps are subjected to the same number of strokes, the pumps do not show a tendency to diverge in performance.

When using the pump change approach, if the process does not stop at an even number of shifts, this can lead to a differential error in the volume balance of physiological saline and outlet fluid. Thus, in one embodiment, the system is configured to stop only after completing an even number of shifts, unless the system switches to manual control. The potential impact of a problem leading to a pure differential error can also be mitigated by more frequent pump changes. In any case, it can be guaranteed that any net difference will not go beyond the originally established boundary for the maximum allowable net loss or gain in the liquid, for example ± 200 ml. Thus, in one embodiment, the present invention comprises a controller capable of communicating with all active pumps. The controller contains software with a counter that monitors, in increments, the number of pump changes. With an odd number of pump changes, the controller generates a blocking signal that prevents the system from shutting down. The controller cancels the blocking signal when the counter is an even number, thus allowing system shutdown. The controller is additionally responsible for transmitting a change signal, which instructs the respective valves to open and close, and thus change the pumps.

During the pump change process, a small amount of residual liquid will transfer from one section of the pipeline to another. For example, if the peristaltic pump tubing is 0.8 ml / inch and the length of the pump tube segment is 3 inches, the remainder will be 2.4 ml (3 inches × 0.8 ml / inch = 2.4 ml) for each time period . Over an approximate period of 50 minutes and at a flow rate of 200 ml / min, 10 liters of liquid will be pumped (50 min × 200 ml / min = 10,000 ml). Thus, the percentage of the residue to the total volume of injected fluid in liters is only 0.024% (2.4 ml / 10,000 ml = 0.024%). The effect of even this small percentage of the residue will be reduced to zero, since the transition between the sections of the pipeline occurs due to the change of pumps, which negates the resulting effect.

Regarding the issue of transferring residual fluid from one section of the pipeline to another, the fluid coming from the dialyzer comes only from the patient, and thus it is completely safe to direct this fluid back into the patient's body together with sterile saline.

As mentioned earlier, during dialysis, additional fluid can optionally be removed from the patient’s body in the form of an ultrafiltrate (UV), and for this purpose, a UV pump is provided in the system of the present invention. Additionally, volumetric accuracy is maintained regardless of the amount of UV removed.

When pumping out the ultrafiltrate to remove excess fluid from the patient’s body, if the system has a low productivity, for example, of the order of 10 ml / min, in contrast to high performance, for example 200 ml / min, the desired overall volumetric accuracy is facilitated. For example, if the required accuracy is ± 30 ml, then over a period of 60 minutes, 600 ml will be pumped at a capacity of 10 ml / min. This suggests that a percentage accuracy of 30 ml / 600 ml = 0.05 or 5% is achieved, which is acceptable for production. However, it will be apparent to those skilled in the art that the system of the present invention is capable of achieving the desired volumetric accuracy regardless of the performance of the UV pump in the dialysis device.

Disposable Conductivity Sensor

Fig. 86 shows, among other elements, a disposable conductivity sensor 8690 comprising a tubular section, the first end of which is for receiving a first disposable segment of a pipeline, and the second end is for receiving a second disposable segment of a pipeline. The tubular section contains a first plurality of probes that extend into the internal volume formed by the tubular section and create a fluid flow channel. In one embodiment, at least three separate elongated probes are used. In another embodiment, at least four separate elongated probes are used.

The disposable conductivity sensor 8690 is configured to attach to an additional, docking second set of probes that are firmly and / or permanently attached to the outside of the control unit. Preferably, the attachment point comprises a portion of the outer surface of the control unit close to or on the same side of the dialyzer, as described previously in connection with FIG. From an operational point of view, the disposable conductivity sensor 8690 is fixed in a temporary, but connected, relationship with an additional, docking set of non-disposable probes. Thus, the second plurality of probes is included in the first plurality of probes and communicates with them. Then the probes act by emitting and recording signals in the liquid flow channel formed by the first disposable segment of the pipeline, the tubular section of the conductivity sensor and the second disposable segment of the pipeline, which were discussed here earlier, with subsequent transmission of the recorded signals to the memory and to the processor in the control unit for use with control and adjustment of the dialysis system.

Valve systems

In order to control flow through the blood and dialysate pipelines and select the desired mode of operation (hemodialysis or hemofiltration), in one embodiment, the system is equipped with two-way valve (s) as described above. These valves can be activated by the user to direct the dialysate flow either through the dialyzer in one operation mode, or to deliver the infusate-quality dialysate flow directly to the patient, in the second operation mode. These two-way valves can also be combined with a compact dialysis manifold. This is illustrated in FIG. It should be noted that in Fig.68-70, for clarity, the corresponding elements have the same legend.

68, the extracorporeal blood processing system 6800 comprises a plastic molded compact manifold 6810 that includes a plurality of molded hydraulic blood and dialysate channels, as well as a plurality of sensor areas, valves, and hydraulic pump segments. The dialyzer 6805, when connected to the arterial blood tube 6801 and the venous blood tube 6802 of the collector 6810, completes the piping of the 6800 system. In one embodiment, the dialyzer 6805 is disposable. Two lines, 6803 and 6804, are used to circulate spent and fresh dialysate, respectively. In order for the 6800 system to work in any of two modes (hemodialysis and hemofiltration), a two-way valve 6845 and a duplicate two-way valve 6846 are provided.

Duplicate valve 6846 is used because the dialysate used in hemodialysis is not sterile and not suitable for infusion, unlike the fluid used in hemofiltration. When operating in hemodialysis mode or if there is a leak or other failure of the 6845 valve, the 6846 valve provides double protection against this fluid being pumped into the patient’s bloodstream. The inclusion of a redundant valve 6846 allows the safe use of a single collector for both hemodialysis and hemofiltration. As mentioned above, two-way valves, such as a redundant valve 6846, consist of two one-way valves. In this case, both one-way valves are connected in series, due to which closing both ports of the two-way valve 6846 provides double protection, preventing dialysate from entering the bloodstream. In an alternative embodiment, the collector can thus be made for hemodialysis only, without providing a connection between the dialysis fluid conduit and the blood conduit, thereby making valve 6846 safe to exclude.

Figa illustrates in more detail the pipeline for the hemodialysis / hemofiltration system according to one variant of implementation of the present invention. The spent dialysate and fresh dialysate tubes 6903 and 6904, respectively, are connected to the dialysate regeneration system 6906, thereby completing the dialysate of the 6900 system. The dialysate regeneration system 6906 further comprises disposable 6915 sorbent cartridges and a 6934 reservoir for holding the dialysate cleaned with 6915 cartridges. Other components The systems shown in FIG. 69A are explained with reference to FIG. 69B, which shows a detail view of an extracorporeal blood processing system 6900 configured for use in hemodia. Isa. The corresponding elements in FIGS. 69A, 69B and 69C have the same conventions.

Blood pipe 6920 contains a peristaltic blood pump 6921, which pumps the patient's contaminated arterial blood through a tube 6901 and pumps blood through the dialyzer 6905. A syringe device 6907 injects an anticoagulant, such as heparin, into the pumped contaminated blood stream. A pressure sensor 6908 is located at the inlet of the blood pump 6921, and pressure sensors 6909 and 6911 are located before and after the dialyzer 6905 to monitor the pressure at these observation points.

Since the purified blood flows from the dialyzer 6905, returning to the patient, a blood temperature sensor 6912 is provided on the line to monitor the temperature of the purified blood. An air eliminator 6913 is also provided to remove gas bubbles that accumulate in pure blood from the dialyzer. A pair of air sensors (bubbles) (or, optionally, a single sensor) 6914 and a clamping valve 6916 are used in the pipeline to prevent the accumulated gas from returning to the patient's body.

Dialysate 6925 contains two dual-channel pulsating dialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 pump spent dialysis fluid from dialyzer 6905 and regenerated dialysis fluid from reservoir 6934, respectively. At the point where the used dialysis fluid from the dialyzer 6905 enters the dialysate 6925, a blood leakage sensor 6928 is provided to detect and prevent any blood leakage into the dialysate. Then the spent dialysate from the dialyzer exit 6905 passes through the bypass valve 6929 to reach the two-way valve 6930. The pressure sensor 6931 is located between the valves 6929 and 6930. An ultrafiltrate pump 6932 is provided in the dialysate line, which is periodically used to extract ultrafiltrate waste from the spent dialysate and store it in a bag 6933 ultrafiltrate, which is periodically emptied.

As mentioned previously, spent dialysate is regenerated using sorbent cartridges. The dialysate regenerated by the sorbent cartridge 6915 is collected in a reservoir 6934. The reservoir 6934 includes conductivity and ammonia sensors 6961 and 6962, respectively. From reservoir 6934, regenerated dialysate passes through a flow restrictor 6935 and pressure sensor 6936 to achieve a two-way valve 6937. Depending on the patient's requirements, the desired amount of infusion solution from reservoir 6950 and / or concentrate solution from reservoir 6951 can be added to the dialysis solution. An infusate and concentrate are sterile solutions containing minerals and / or glucose that help maintain minerals, such as potassium and calcium, in the dialysis solution at levels prescribed by your doctor. A bypass valve 6941 and a peristaltic pump 6942 are provided to select the desired amount of infusate and / or concentrate solution and to ensure the correct flow of the solution into the purified dialysate coming from reservoir 6934.

The dialysate conduit contains two two-way valves 6930 and 6937. The valve 6930 directs one spent dialysate stream to the first channel of the dialysate pump 6926 and the other spent dialysate stream to the first channel of the dialysate pump 6927. Similarly, valve 6937 directs one regenerated dialysate stream to the second channel of the dialysate pump 6926 and another stream of regenerated dialysate into the second channel of the dialysate pump 6927.

The spent dialysate flows from pumps 6926 and 6927 are collected by a two-way valve 6938, while the regenerated dialysate flows from pumps 6926 and 6927 are collected by a two-way valve 6939. The 6938 valve combines two spent dialysate flows into one stream, which is pumped through a pressure sensor 6940 and through sorbent cartridges 6915 where the spent dialysate is cleaned and filtered, and then collected in reservoir 6934. Valve 6939 combines the two flows of regenerated dialysate into one stream, which flows to the 6945 two-way valve through a bypass valve 6947. A pressure sensor 6943 and a dialysate temperature sensor 6944 are provided on the dialysate flow path leading to a two-way valve 6945.

When the two-way valves 6930, 6937, 6938 and 6939 are inverted, two pumps 6926 and 6927 act in the opposite direction, one of which pumps out the dialysis solution from the dialyzer 6905, and the other feeds the dialysis solution into the dialyzer 6905. Such treatment is carried out periodically for short in comparison with a dialysis session of time periods, it ensures that for a longer period of the entire dialysis session, the volume of the dialysate pumped into the dialyzer is equal to the amount of pumped liquid, and ultrafiltrate OS 6932 only removes the total volume of fluid lost by dialysate 6925, as discussed above.

In hemodialysis mode, the 6945 two-way valve allows the regenerated dialysate to enter the dialyzer 6905 to ensure normal hemodialysis of the patient’s blood. One side of the 6945 valve leading to the patient’s return line closes. Another two-way valve 6946 acts as an understudy that protects the patient’s blood line from getting dialysate by closing both ports of valve 6946, even in the event of leakage or failure of valve 6945.

As shown in FIG. 69C, in hemofiltration mode, a two-way valve 6945 can be activated to direct fresh ultrapure dialysate from reservoir 6952 through valve 6946, this time with both ports open for direct injection of purified blood from the dialyzer and flowing back to the patient .

Specialists in the art should not pay attention to the fact that the duplicate two-way valve 6946 is an excess safety valve, which ensures that in the hemodialysis mode the failure of one valve 6945 does not infuse the regenerated dialysate directly to the patient. Thus, both valves 6945 and 6946 are capable of being activated by the system so that fluid can be routed into the patient's venous blood line for safety reasons. In one embodiment, the two-way backup valve 6946 is the only valve that opens or closes the fluid flow path.

Specialists in the art should additionally pay attention to the fact that the valves presented in the above description are referred to as “bypass” or “two-way” depending on their use. Thus, valves are called 'bypass valves' when they bypass a component, such as a dialyzer. Otherwise, they are called 'two-way valves' and simply direct the flow in at least two directions. However, the bypass and two-way valves can be of the same design.

In one embodiment, the two-way valves used in the present invention are made in the form of elastomeric membranes that are pressed against the opening by a mechanism contained within the dialysis apparatus to stop the flow having fluidic contact with the rest of the hydraulic system, which is further discussed below.

Two-way valves 6945 and 6946 can be used to change the operating mode of the blood processing system. On Figs shows the flow of fluid in the pipelines 6920 and 6925 for blood and dialysate. Since the system operates in a hemofiltration mode, the spent dialysate tube 6903 is connected to the drain, while the fresh dialysate tube 6904 is connected to the fresh ultra-pure dialysate reservoirs 6952 suitable for injection. Fresh dialysate through a settling chamber 6953 with a spherical valve passes through a heating bag 6954, entering the tube 6904 of fresh dialysate. The remaining elements and hydraulic channels of the blood and dialysate pipelines 6920, 6925 are similar to those shown in FIG. 69B, except that in dialysis, fresh dialysate or saline flows into dialysate 6925, while the spent dialysate is discharged and not reused. Also, components 6942, 6950, 6941 and 6951 are not used in the infusion subsystem.

Blood line 6920 contains a peristaltic blood pump 6921, which pumps the patient's contaminated arterial blood through a tube 6901 and pumps blood through the dialyzer 6905. An optional pump 6907 injects an anticoagulant, such as heparin, into the pumped contaminated blood stream. A pressure sensor 6908 is located at the inlet of the blood pump 6921, and pressure sensors 6909 and 6911 are located before and after the dialyzer 6905. The purified blood from the dialyzer 6905 is pumped through the tube 6902 after the blood temperature sensor 6912, air eliminator 6913 and air sensors 6914 (bubbles) and back to the patient's vein. It is also located that the clamping valve 6916 completely stops blood flow if the bubble sensor 6914 detects air in line to the clamping valve 6916, which prevents air from entering the patient's body.

Dialysate 6925 contains two dual-channel dialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 pump spent dialysis fluid from dialyzer 6905 and fresh dialysis fluid from reservoirs 6952, respectively. The spent dialysate from the dialyzer exit 6905 is pumped through a blood leakage sensor 6928 and a bypass valve 6929 to reach the two-way valve 6930. A pressure sensor 6931 is located between the valves 6929 and 6930. The ultrafiltrate pump 6932 is periodically used to extract ultrafiltrate waste from the spent dialysate and store it in a bag 6933 ultrafiltrate (which is periodically emptied). Fresh dialysate from tanks 6952 passes through a flow restrictor 6935 and a pressure sensor 6936 to achieve the two-way valve 6937. It will be apparent to those skilled in the art that no infusion and concentrate are required in this protocol, and elements 6941, 6942, 6950, 6951 associated with these functions , can not be used.

Heating bag 6954 raises the temperature of the fresh dialysate sufficiently that the temperature of the ultrafiltered blood returning to the patient from the dialyzer 6905, or the total temperature of the mixture of ultrafiltered blood from the dialyzer 6905 and fresh dialysate injected directly into the purified blood by activating valves 6945, 6946, is equivalent patient temperature to avoid any heat shock.

On Fig shows an alternative embodiment of hydraulic systems, where a duplicate two-way valve 6946 is not used. The blood line contains a peristaltic blood pump that pumps the patient’s contaminated arterial blood through a tube 7001 and pumps blood through the dialyzer 7005. A syringe or pump 7007 injects an anticoagulant, such as heparin, into the pumped contaminated blood stream. A pressure sensor 7008 is located at the inlet of the blood pump, and pressure sensors 7009 and 7011 are located before and after the collector segment. The purified blood from the dialyzer 7005 is pumped through a tube 7002 after the blood temperature sensor 7012, an air eliminator 7013 and an air sensor (bubbles) 7014 and back into the patient's vein. The clamping valve 7016 is also located before the pipeline connection with the patient to completely stop blood flow, if air is detected by the air sensor 7014 (bubbles) in the line to the clamping valve 7016, which does not allow air to reach the patient.

The dialysate 7010 contains two pump segments of dialysate 7026, 7027, connected in pressure to the pumps. Dialysate pump segments 7026, 7027 pump the spent dialysis fluid from dialyzer 7005 and the regenerated dialysis fluid from reservoir 7034, respectively. The spent dialysate from the dialyser outlet 7005 is pumped through a blood leak sensor 7028 to reach the bypass valve 7029. The flow sensor 7020 is one of two flow sensors (the other of which is a flow sensor 7046) that determine the amount of dialysate flowing through the pipeline. Valve 7030 is similar in design to a two-way valve and is used to bypass the dialysate pump 7026. Valve 7030 is usually closed in the bypass direction. If the dialysate pump 7026 stops, the valve 7030 opens to direct the flow bypassing the pump 7026. The pressure sensor 7031 is located between the flow sensor 7020 and the valve 7030. In normal flow, the spent dialysate is pumped through the pressure sensor 7040, tube 7003 and sorbent cartridges 7015, where spent dialysate is purified and filtered. The purified / filtered dialysate then enters reservoir 7034. The ultrafiltrate pump 7032 is periodically used to recover ultrafiltrate waste from spent dialysate and store in the bag an ultrafiltrate (not shown) that is periodically emptied.

The regenerated dialysate from tank 7034 passes through a pipe 7004, a flow restrictor 7035, a dialysate temperature sensor 7044, a flow sensor 7046 and a pressure sensor 7036 to reach the two-way valve 7045 through the bypass valve 7041. When the corresponding flow channels of the bypass valves 7029, 7045 and 7041 are activated, they direct regenerated dialysate bypassing dialyzer 7005. Flows of infusate and concentrate from reservoirs 7050, 7051 of infusate and concentrate are routed by pump segments 7042, 7043 of infusate and concentrate to purified dialy atm, coming from the reservoir 7034 through tube 7037 and after the spent dialysate flow sensor 7020, respectively.

The two-way valve 7045 determines in which mode the system operates. Thus, in one mode of operation, the two-way valve 7045 allows the regenerated dialysate to enter the dialyzer through the tube 7060 to ensure normal hemodialysis of the patient’s blood. In another mode of operation, a two-way valve 7045 is activated to direct the fluid flow of an ultrapure dialysis fluid of infusate quality into the venous blood line and directly to the patient. Accordingly, universal valves allow you to switch the mode of operation between hemofiltration and hemodialysis. For example, in the hemofiltration shown in FIG. 69C, a fluid suitable for infusion is routed through three valves directly into the bloodstream, where valve 6946 is connected to a post-dialyzer. In this mode, valve 6945 prevents the dialysate from entering the lower port of the dialyzer. In the hemodialysis shown in FIG. 69B, valve 6946 is closed and valves 6947 and 6945 direct the dialysis fluid to the dialyzer. It should be noted that the embodiment shown in Fig. 69B uses a pump change and a plurality of valves to control the volume of liquid, while the embodiment shown in Fig. 70 uses flow sensors 7020 and 7046 to control the volume of liquid.

As discussed above, the valves are preferably implemented in the manifold using elastic membranes at flow control points, which are selectively blocked, as necessary, by protrusions, pins, or other parts extending from the manifold apparatus. In one embodiment, fluid blocking is provided using a safe, low-power solenoid valve.

The valve system contains a magnetic biasing system that is lightweight and consumes minimal power, making it ideal even when the portable artificial kidney system uses a disposable manifold for hydraulic systems. The system can be used in conjunction with a hole in any design. In particular, an opening is any opening, opening, cavity or compartment in any type of material. This includes ducts in the pipeline, manifolds, disposable manifolds, ducts, and other ducts. It will be apparent to those skilled in the art that the valve system disclosed herein will be implemented with a disposable manifold by accommodating the bias part and magnets, which are further discussed below, outside the manifold in the desired valve position. The actuator is also separate and different from the disposable collector and, in general, part of the non-disposable portion of the artificial kidney system.

From a functional point of view, the valve of the present invention has two stable states: open and closed. It works by using magnetic forces to move the displacement part to the diaphragm and thus create sufficient force to press the diaphragm against the valve seat, causing the diaphragm to close the hole. Closing the hole blocks the flow of fluid. The reverse process, namely the use of magnetic forces to move the bias part from the diaphragm and thus release the diaphragm from being pressed against the valve seat, opens the hole and allows fluid to flow.

Obviously, although the present invention should be considered in connection with the preferred embodiment depicted in Figs. 71A and 71B and the non-preferred embodiment depicted in Fig. 73, the present invention generally relates to any use of the valve in an artificial kidney system. having the following attributes: a) two stable states, open and closed, b) a change in state requires a supply of energy, c) maintaining a state does not require a supply of energy, d) a state is changed by using Hovhan magnetic forces for changing the position of the displacement parts which, when changed, requires the valve to open or close.

In one embodiment, according to FIGS. 71A and 71B, the valve system 7100 of the present invention is used to control fluid flow through a hydraulic flow channel 7102, which is limited by valve seats 7104 to thereby create an annular valve clearance 7103. Clearance 7103 is any opening, opening, cavity or compartment in any type of material, in particular collectors, disposable collectors, channels and other ducts 7110. Valve 7100 is shown in the open state. Valve system components include a hole closure part, a bias part, a mechanism for moving the bias part, an optional optical sensor, a coil drive circuit, and an actuator having a coil.

In one embodiment, the hole closure part comprises a diaphragm 7106, which, being compressed by the displacement part, as discussed below, is pressed against the valve seats 7104, thereby closing the valve annulus 7103. In the open state, the diaphragm main body 7106 is separated from the valve seats 7104 by a gap 7198. In one embodiment, the diaphragm 7106 is made of soft material, for example silicone rubber. Aperture 7106 must maintain its shape, temperature, and activation over time. The valve 7100 relies on the material of the diaphragm 7106 to return to its uncompressed form, while eliminating the bias details (compression force) in the open state.

It will be apparent to those skilled in the art that the hole closure part may comprise any combination of a spring, compressible or incompressible structures that, when pressed by the displacement part, closes the hole. In one embodiment, valve seats 7104 may be molded into the manifold. Suitable materials for the valve seat are polycarbonate, ABS and similar plastics. The clearance 7103 of the valve in a preferred embodiment takes values from 0.1 to 0.3 inches in diameter (and, in a more particular case, 0.190 inches). The lumen dimensions may increase to increase flow for variable applications of the invention or, alternatively, decrease to decrease flow for variable applications.

In one embodiment, the biasing part comprises a plunger cylinder, or housing 7110, which, when the valve is open, is aligned with the diaphragm 7106 but slightly compresses the diaphragm 7106. A pliable component, such as a spring 7112 and a head, is located inside the plunger cylinder 7110 7199 plungers that are separated by an air gap 7114. The plunger cylinder 7110 is externally sealed with a fluid seal 7120, which, in one embodiment, is a thin, soft silicone rubber washer. In one embodiment, the plunger cylinder 7110 is pressed against the silicone rubber washer and compresses the washer to form a fluid seal 7120. When closed, the plunger cylinder 7110 is not pressed against the washer, which is thus not compressed and fits freely in the end cap 7130 A spring 7112 is any resilient or pliable material and, in one embodiment, comprises a wave spring.

The plunger cylinder 7110, the inner spring 7112, the air gap 7198, the plunger head 7199, the plunger body 7140, and the core 7142 are components of a preferred bias part of the present invention. In one embodiment, the plunger body 7140 has an outer diameter in the range of 0.1 to 0.2 inches (more particularly 0.122 inches) and a length of about 0.5 to 2.5 inches. Obviously, the body of the 7140 plunger is any rod structure of any length, depending on the application. The body 7140 of the plunger is located in an annular core 7142, which has one larger end and one smaller end, and is attached to the core by any method known to a person skilled in the art, including epoxy glue, screw connection, pin connection or welded connection. The outer diameter of the larger end 7142 of the core is from 0.3 inches to 0.5 inches (and in a more particular case 0.395 inches), the thickness is from 0.03 to 0.15 inches (and in a more particular case from 0.05 to 0 , 10 inches), and the length is from 0.50 to 1.75 inches (and in a more particular case, 1.05 inches). The small end 7142 of the core has a diameter of from 0.1 to 0.4 inches, and in a more particular case 0.25 inches.

The small end of the core is at least partially enclosed by the coil frame 7195, which holds the coil 7148 in place and ensures the dimensional stability of the coil 7148. There is preferably a gap between the coil frame 7195 and the core 7142. The gap size is from about 0.01 to 0.03 inches (and more particularly 0.02 inches). The coil frame 7195, in one embodiment, is a fiberglass reinforced nylon structure that must be non-metallic and non-ferromagnetic. The coil frame 7195 is a ring structure with a sufficient outer diameter to ensure a snug fit into the channel of the housing and a sufficient inner diameter to enclose the core so that it has enough space to move and some degree of thermal expansion. Two end caps 7130, 7160 fix the frame 7195 in place and keep it from moving or sliding, in particular, under the influence of electromagnetic forces.

The body of the plunger is made of a metal or non-metallic material, for example, brass or fiberglass, and the core is also made of metal, in particular steel. Preferably, the plunger body is non-magnetic and the core body is ferromagnetic. As further discussed below, the plunger body 7140 and the core 7142 are moved by a mechanism to move the displacement part.

The mechanism for moving the biasing part contains a large magnetic component, a small magnetic component and a housing containing magnets and a portion of the biasing part, namely, the plunger body 7140 and the core 7142. In a more particular case, according to Figs. 71A and 71B, a mechanism for moving the part the bias contains an end cap 7130 of a large magnet, for holding and aligning a large magnet, a large magnet 7132, elastic material 7134, a gap 7197, a coil 7148, a small magnetic component 7162, an assembly and end cap 7160 of a small magnet and an elastic ma Trial 7164.

The large magnet end cap 7130 holds and aligns the large magnetic component 7132 and the coil frame 7195 in place in the housing 7170, referred to as the actuator body, which has a through channel through which the components described herein pass. The large magnetic component 7132 must be aligned correctly with the core 7142, the plunger body 7140, and the small magnetic component 7162 to ensure proper movement of the offset part. Both end caps 7130 and 7160 hold in place the frame 7195 of the coil and the coil 7148.

Additionally, a mounting plate may be used to grip and hold the end cap 7130. In one embodiment, the mounting plate is positioned vertically and flush with the end cap side and between the end cap and the channel. The mounting plate has an opening of approximately the same size as the smaller diameter of the end cap. The clamping mechanism holds the body near the plate; alternatively, the plate may be permanently fixed using any fastening method known to those skilled in the art. Unlike the prior art, for example, US patent No. 6836201, in a preferred embodiment, the magnets are located inside and not outside the channel and provide bearings for the plunger, as discussed below.

The large magnetic component 7132 is separated from the core 7142 by a gap 7197 and an elastic material 7134, for example a silicone washer, which, in one embodiment, has an outer diameter of from 0.3 to 0.5 inches (and in a more particular case 0.37 inches, inner a diameter of 0.1 to 0.3 inches (and in a more particular case, 0.188 inches), a thickness of 0.005 to 0.015 inches (and, in a more particular case, 0.01 inches, and a hardness tester of 35 to 45 (and more particularly 40 The small magnetic component 7162 is separated from the core by an elastic material 7164, for example, a silicone washer, which, in one embodiment, existence, has an outer diameter of from 0.1 to 0.4 inches (and in a more particular case 0.24 inches), an inner diameter of from 0.1 to 0.3 inches (and in a more particular case 0.188 inches), a thickness of 0.005 up to 0.015 inches (and in a more particular case 0.01 inches), and a hardness tester from 35 to 45 (and in a more specific case 40). The small magnetic component 7162 is held and maintained in proper alignment with the housing 7170 mounting and end cap 7160 small magnet . The small magnet end caps 7172 also serve to grip and hold the small magnet end caps 7160 in place.

71A, the valve system of the present invention further comprises a coil exciter circuit board 7150 that drives an actuator comprising a coil 7148, and is preferably attached to the actuator body 7170 by small screws, a coil exciter connector 7154 and an optical sensor 7152, which registers the position of the large end 7196 of the core. Coil 7148 is used to implement changes in magnetic fields to cause the movement of 7142 core and body 7140 of the plunger. In one embodiment, the coil has a length of from about 0.05 to 1.5 inches (and in a more particular case 1 inch), an outer diameter of from 0.35 to 0.55 inches (and in a more particular case 0.46 inches) and an internal diameter of 0.15 to 0.35 inches (and, more particularly, 0.26 inches), with six layers of 29 AWG wire.

Various elastic materials used in the bias part and the mechanism to move the bias part provide a “soft” barrier to the movement of the shaft 7140 when the valve opens or closes. In particular, this ensures that the movement of the core does not damage the magnets.

The large magnetic component 7132 may be a single solid magnet or, in a preferred embodiment, consist of many, for example three, magnets. The small magnetic component 7162 can also be solid or composed of multiple magnets. In one embodiment, the magnets are preferably made of magnetic materials based on alnico, samarium-cobalt alloy, neodymium, rare earth elements or ceramics. In one embodiment, the large magnet 7132 is a neodymium ring magnet with 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 a particular case of 0.125 inches) and a length of 0.2 to 0.5 inches (and in a more particular case, 0.375 inches). In one embodiment, the small magnet 7162 is in the form of a neodymium ring magnet, with an outer diameter of 0.15 to 0.4 inches (and in a more particular case 0.25 inches), an inner diameter of 0.05 to 0.3 inches (and in the more particular case of 0.125 inches) and a length of from 0.15 to 0.4 inches (and in the more particular case of 0.25 inches). The larger magnet 7132 is used closer to the hole closure part since the size is necessary to apply sufficient reaction force to the valve seat. Additionally, the activation force developed by the activation coil is essentially the same, although the magnets have different sizes, which makes it possible to simplify the drive circuit of the coil.

In one embodiment, the shaft, plunger, or other elongated part 7140 uses the center holes of the magnets as a linear bearing. Accordingly, the center holes of the magnets should preferably have a supporting surface, for example, chrome plated or any smooth hard surface with minimal friction. A gap is formed between the coil frame 7195 and the core 7142 due to thermal expansion of the frame, creep of the frame over time, and tolerances of the frame, core, and magnet. However, under all operating conditions, the clearance should be sufficient so that the body of the plunger 7140 can move freely and not get stuck in the holes of the magnets and coils. In a preferred embodiment, the clearance is from about 0.01 to 0.06 inches (and more particularly 0.02 inches) at room temperature.

When the valve is closed, according to FIG. 71B, the valve system 7100 of the present invention controls the flow of fluid through a hydraulic flow channel 7102, which is limited by valve seats 7104, compressing a hole closure member, such as orifice plate 7106, and thereby block valve annulus 7103. In the closed state, the diaphragm main body 7106 is pressed against the valve seats 7104 and, accordingly, essentially eliminates the gap 7198 (shown in Fig. 71A).

Being in close proximity to the diaphragm 7106, the displacement part now compresses the diaphragm 7106. In particular, the plunger cylinder 7110 is moved to compress the diaphragm 7106. The plunger cylinder 7110 moves because the change in magnetic fields causes the core body 7142 to move to the large magnetic component 7132. The body 7142 of the core stops moving when the core head 7196 passes through the gap 7197 (in Fig. 71A) and stops on the elastic material 7134 located next to the large magnetic component 7132. Moving 7142 the core also leads to the movement of the body of the plunger 7140 to which the core 7142 is connected. The movement of the body of the plunger 7140 causes the head of the plunger 7199 to move in the plunger cylinder 7110, passes through the gap 7114 (in Fig. 71A) and compresses the spring 7112. At a certain amount of compression, the plunger cylinder 7110 moves and compresses the diaphragm 7106. The movement of the plunger cylinder 7110 creates a new gap 7192 between the body 7110 of the plug and the elastic material 7120, which is located next to the end cap 7130 of a large magnet.

As shown in FIG. 71B, other valve components remain unchanged, including actuator body 7170, coil drive circuit 7150, coil connector 7154, coil 7148, coil frame 7193, small end cap screws 7172, optical sensor 7152, and small magnet end cap 7160 . However, it is obvious that, due to the movement of the core 7142, a gap 7195 is formed between the smaller end of the core 7194 and the elastic material 7164, which is located next to the small magnetic component 7162.

Obviously, to close the valve, the biasing part applies force to the bore closing part, for example, diaphragm 7106. The force that the biasing part must develop to deform the diaphragm to the point where the diaphragm touches the valve seat is essentially linear and can be modeled by a linear spring. However, the required force increases exponentially as the diaphragm is pressed into the valve seat. Thus, the force profile for the displacement part becomes non-linear and much more complex. Accordingly, a number of specific problems arise associated with the valve design and tolerances between the various components of the bias part, the hole closure part and the solid stopper of the bias mechanism. The bias mechanism must be capable of delivering a non-linear force profile without permanent deformation of the diaphragm. This means that the mechanism must deliver the right amount of force.

As discussed above, the bias part includes a rod, plunger, or other elongated part that is connected to another structure, called a core, which has a larger diameter and can function as a stop if it is forced to come close to another structure, such as the surface of a magnet. It will be apparent to those skilled in the art that the displacement part or moving part is not limited to the configuration of the rod and cylinder. On the contrary, it may include non-cylindrical structures, integral fragments, or multiple fragments, welded or in any other way connected to each other. As a result, the displacement part may contain many different designs, provided that the displacement of the part can exert the necessary force on the compression part of the hole in a reliable and consistent manner.

For example, FIG. 73 shows an alternative, less preferred embodiment. In relation to dialysis treatment of the kidneys, this embodiment usually does not provide reliable maintenance of the valve in a closed state. The bias part 7300 comprises a housing 7305, which includes an electromagnet 7310 of a substantially cylindrical structure with a through channel 7315 passing through it. An electromagnet 7310 is securely fixed to the center of the housing 7305 by non-magnetic struts 7320, which, in one embodiment, are end caps. End caps have two purposes: to hold the magnets in place and to hold the coil in an intermediate position. In one embodiment, elements 7331 and 7320 comprise a first integral part and elements 7305 and 7320 comprise a second integral part. A cylindrical ferromagnetic core 7325 having a first surface 7323 and a second surface 7324 is arranged so that the portion of the core 7325, between the first surface 7323 and the second surface 7324, has a linearly sliding fit with channel 7315. The second surface 7324 is sufficiently larger than channel 7315, which limits the linear motion of core 7325. In one embodiment, the dimensions of the second surface and the first surface are different to generate sufficient magnetic force to keep the valve closed that position. The core 7325 is capable of linearly sliding to the left and right in channel 7315.

Two magnets 7330, 7335 of different sizes are also mounted in and on the two end caps 7331, 7332 of the housing 7305. The first surface 7323 of the core 7325 is in contact with the first magnet 7330 to provide the first stable state of the biasing system 7300, and the second surface 7324 of the core 7325 is in contact with a large magnet 7335 to provide a second stable state of the bias system 7300. The permanent magnets 7330, 7335 are designed to fit within the diameter of the housing 7305, as this reduces the size of the bias system 7300. The first rod 7340 connected to the first surface 7323 of the core 7325 passes through the first magnet 7330, thus extending beyond the housing 7305 at one end, and the second rod 7345 connected to the second surface 7324 of the core 7325 passes through the second magnet 7335, such thus extending beyond the housing 7305 at the other end. The rods 7340, 7345 can be made of corrosion-resistant, non-magnetic material known in the prior art, for example, but without limitation, brass. Although in one embodiment two rods are provided connected to two core surfaces, in an alternative embodiment, only one rod is provided connected to one of the shuttle surfaces.

It will be apparent to those skilled in the art that the magnetic force with which the electromagnet 7310 acts on the core 7325 is large enough to overcome the holding force of the permanent magnets 7330, 7335, which allows the biasing system 7300 to transition from the first stable state to the second. In addition, it will be apparent to one of ordinary skill in the art that the rod / plunger 7345 moves with the core 7325, thereby creating a driving force to compress or expand the hole closure part. However, it was determined that this embodiment is worse than the first embodiment, since it does not allow to maintain the closed state efficiently enough.

Let us pay attention to several design features of the hole closing part, which works in conjunction with the part and the biasing mechanism. Firstly, according to Fig. 74, and as discussed above in connection with Figs. 71A and 71B, there is a gap 7408 between the plunger cylinder 7404 and the hole closing part 7405, in particular, the first diaphragm surface 7405. The gap 7408 is from 0.040 to 0.070 inches and, in a more particular case, approximately 0.055 inches. The diaphragm contains silicone, preferably 0.040 inches thick, and can be modeled as a spring (K _V2 ) having a spring constant of 270 lbf / in. The second diaphragm surface 7406 is separated from the valve seat 7407 and is subjected to magnetic forces 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 transmits force developing magnetic attraction to the magnet 7401 of the core 7403, the simulated spring K _P, which is separated from the head washer core 7401, e.g., 0.010 inches of silicone in the closed state and is separated from the head 7401 of the core about 0.110 inches in the open state. This silicone washer provides forces that are modeled as a spring, K _SL . The core 7401 is connected to the rod 7404. When the valve is activated, the rod 7404 moves towards the valve seat 7407, since the core to which the rod is connected moves towards the large magnet 7403.

74, according to, K _V2 K _SL and correspond to the elastic material, for example silicone, that are modeled as rigid springs. Obviously, when the valve is in a closed state, there are two positions of importance. The first is the position of the rod relative to the diaphragm, and the second is the position of the surface of the core relative to the large magnet. When the valve is closed, the stem is pressed against the valve diaphragm with sufficient force to resist at least 600 mmHg. Art. back pressure generated in the fluid channel of the artificial kidney system. In this embodiment, fluid pressures can reach 2600 mmHg. Art., and this 7400 system is designed to maintain the diaphragm firmly pressed against the valve seat to provide bore seals up to 2600 mmHg. Art. inclusive.

Additionally, when the valve is closed, a large surface of the core is attracted or directly pressed against the large magnet. Magnetic attraction of the core to a large magnet generates the force that the rod exerts on the hole closure member, such as the diaphragm. To generate a consistent and sufficient force, the spacing between the surface of the core and the surface of the large magnet must be consistent. Thus, it is preferable to place the elastic material 7402 between the core surface 7401 and the magnet surface 7404. The elastic material has a non-linear spring constant and will compress until the resulting forces for the elastic material are equal to the magnetic forces. When the shaft applies force to the diaphragm through the core, the core will experience the resulting force. To ensure a static state, the sum of these forces on the core should be zero. In addition, the elastic material serves to protect the surface of the magnet from chipping or destruction during activation.

76, when the valve 7600 is in the closed state, the core head 7605, 7602 moves from the small magnet surface 7601 (from position 7602a to position 7602). At 7602, the core head is separated from the small magnet 7601 by an elastic material 7617, for example, a silicone washer having a thickness of about 0.015 inches. Moving to position 7605, the core head moves approximately 0.140 ± 0.20 inches, including a distance of 0.45 ± 0.005 inches, during which the shaft 7608 does not move, and is stopped by an elastic material 7616 (for example, a silicone washer having a thickness approximately 0.015 inches), which separates the core head 7605 from the surface of the large magnet 7606. The large magnet 7606, in turn, is separated from the rod head 7607.

When the valve is in the open state, the large magnet 7606 is separated from the rod head 7607 by an elastic material 7615, for example, a silicone washer having a thickness of about 0.015 inches. When the valve is closed, the large magnet 7606 is separated from the rod head 7607 by an elastic material 7615, for example, a silicone washer having a thickness of about 0.015 inches and a distance of about 0.055 ± 0.10 inches. When closing the valve, the rod head 7607 moves away from the large magnet 7606 and the elastic material 7615, approaching the valve seat 7610. In particular, the rod head 7607 moves to compress the diaphragm 7608 and thereby press against the elastic material 7609 (for example, silicone having a thickness of about 0.040 inches), which in turn is pressed against the valve seat 7610. This causes the valve to close with an approximate force of 14 N.

Obviously, the configuration of the part and the biasing mechanism with respect to the hole closing part and the tolerances described here provides the diaphragm displacement profile 7500 shown in FIG. 75, which is suitable for applications where there is a need to resist at least 600 mmHg. Art. counterpressures, for example, artificial kidney systems. 75 shows an exemplary diaphragm displacement profile 7501, where the force 7502 exerted by the displacement part is plotted along the y axis and the corresponding diaphragm offset is plotted along the x axis. The inflection point on this curve 7503 indicates when the diaphragm begins to press against the valve seat. To the left of the inflection point 7503, the diaphragm bends forcibly to the valve seat, but does not substantially press against the valve seat. To the right of the inflection point 7503, the diaphragm bends around the valve seat, while the diaphragm material is deformed, which violates a good seal against fluid pressure.

Another important component of the bias mechanism system is the activation system 7200 depicted in FIG. 72. During the activation process, current is passed through coils 7205, resulting in the formation of a magnetic field, which creates a magnetic force opposite to the attractive force of a small magnet. Under the influence of this force, the core considered above begins to move to the closed position (towards the large magnet). When the core moves beyond the point of no return, the attractive forces on the core of the large magnet overcome the attractive forces of the small magnet. To ensure that the opposing forces due to the diaphragm of the valve do not overcome the attractive forces of a large magnet, the gap discussed above is provided.

The coil design is made up of a coil frame and a winding wire 7210. The size of the coil frame is preferably selected based on commercially available coil frames, the potential of the pulsed current of the power source and, in particular, the necessary activation force and voltage of the power source. The activation force is proportional to the magnetomotive force of the coil. In one embodiment, it is preferable to limit the coil current to 6 amperes or less.

Important factors in the design of the coil include the number of layers, packing density, wire diameter and coil resistance. In one embodiment, the present invention uses a frame with 6 layers of wire and a spacing of about 0.010 inches between the diameter of the frame flange and the last layer. When requiring insulation that is equivalent to heavy poly nylon and coil resistance of 3.5 ± 0.5 ohms, the wire size is approximately 29 AWG. You can use the coil frame of any size.

The circuit used to drive the coil is constructed in a bridge circuit that allows current to be reversed for opening and closing operations. The bridge circuit is excited by a unique pulse width modulation (PWM) signal. The PWM signal is used to generate a cosine current pulse through the coil. The period of the cosine pulse is associated with the mass of the core and the reaction force. In a preferred embodiment, a bipolar DC power switch or a polled switch is not used; instead, an optical sensor is provided for determining the position of the core, deciding on the state of the valve and generating an electronic cosine excitation waveform to move the plunger in the desired direction and thereby change the state of the valve.

Optionally, as shown in FIGS. 71A and 71B, as an element 7152, the valve system 7100 uses a sensor, preferably an optical sensor 7152, to determine the state of the valve (open or closed). This can be achieved by placing the optical sensor 7152 in a position where there is a sufficient difference in reflectivity, or other optical properties, between the open state of the valve and the closed state of the valve. For example, when the valve is closed, in one embodiment, the large end 7196 of the core is opposite the elastic material 7134 and the large magnetic component 7132. The large end 7196 of the core is wide enough to be detected by the reflective optical sensor 7152, but not too wide to the optical sensor 7152 could resolve the position. An optical sensor 7152 is located outside the part / biasing mechanism and looks through her / his body, which is preferably made of transparent polycarbonate. The wavelength of the optical sensor 7152 is in the near infrared (NIR), in order to have good transmission through the polycarbonate body. It will be apparent to those skilled in the art that the sensor can be selected to be suitable for construction from any material, provided that it includes appropriate filters. In this case, it is preferable to incorporate an optical long-wave filter into the optical sensor 7152 to provide sensitivity in the NIR.

From a functional point of view, when the core is in the open position, as shown in FIG. 71A, the large end 7196 of the core moves from the field of view of the optical sensor 7152, so that the optical sensor will detect very low reflection. When the large end 7196 of the core is in view, as shown in FIG. 71B, there is a reflection sensed by the sensor 7152, and thus indicating that the core is in the closed position. It will be apparent to those skilled in the art that the sensor 7152 can be positioned to detect a greater reflectivity from the core when the valve 7100 is in the open position and significantly lower reflectivity (as the core goes out of view) when the valve 7100 is in the closed position. Additionally, it will be apparent to one of ordinary skill in the art that a sensor 7152 may be located close to the gap to detect a situation where the gap is present and when there is no gap, thus indicating the state of the valve 7100.

From an operational point of view, according to Fig.77, the valve is initially in one of two states, open or closed. Assuming the valve is in the open state 7701, the first step in closing the valve is to supply power to the coil drive circuit 7702, whereby the magnetic field generated by the coil passes through the core, creating the opposite magnetic force between the core and the small magnet and creating a weak the force of attraction between the large magnet and the large end of the core. When the displacement part begins to move 7703, the attractive forces of the small magnet decrease, while the attractive forces of the large magnet increase. The bias part 7703 moves to the point of no return, after which the bias part 7704 closes the gap 7704 and presses the hole closure part, namely the diaphragm 7705, to the valve seat 7706. Compression of the diaphragm 7706 leads to the fact that the diaphragm closes the hole 7707 and closes the valve 7708.

Assuming the valve is in the closed state 7709, the first step in opening the valve is to supply power to the coil drive circuit 7710, whereby the magnetic field generated by the coil passes through the core, creating the opposite magnetic force between the core and the large magnet and creating a weak the force of attraction between the small magnet and the small end of the core. When the bias part begins to move 7711, the attractive forces of the large magnet decrease, while the attractive forces of the small magnet increase. The bias part moves 7711 to the point of no return, after which the bias part presses the diaphragm 7712 from the valve seat 7713. The hole opens because it is no longer covered by the diaphragm 7714. The offset part returns to its original position and restores the gap 7715, thus returning to the open state 7716.

Since the first and second stable states of the core are maintained even when the power of the electromagnet is turned off, the bias system is able to have low power consumption and low heat generation compared to traditional drives, where a continuous power supply is needed to maintain the states, which leads to an additional increase in heat generation.

Saline backwash

On Fig shows a method and system for the safe and effective implementation of backwash with physiological saline. Traditionally, backwashing with physiological saline, which serves to clean the system with physiological saline, is accomplished by disconnecting the tubular segment 8658, which connects the dialysis blood line to the patient at connection 8651, and attaching the tubular segment 8658 to the saline source 8602 through points 8652 and 8653 of the connection. However, this traditional approach has disadvantages, including breakthrough sterile compounds. Obviously, the connection points can be any type of connection, including Luer locks, snap seats, needleless inserts, valves, or any other form of hydraulic connection.

Another approach to saline backwash involves connecting a source of saline solution 8602 through connection point 8652 to connection point 8653 while maintaining the connection to the patient. Although this avoids the breakthrough of the sterile compound, the patient receives a stream of saline that may contain air bubbles. Since there is usually no air bubble detector in the tubular segment 8658 between the saline solution connection point 8653 and the patient connection point 8651, there is a danger of forming an excessively large air bubble and, due to the lack of a mechanism for detecting such an air bubble and notifying the patient thereof, it enters the bloodstream significant damage to the patient.

Alternatively, the preferred saline backwash approach is designed to maintain a bloodstream connection between the patient and the dialysis system through a tubular segment 8658 that connects to the 8600 collector at port C 8605 and to the patient at connection point 8651 and hydraulically connects the saline source 8602 to the 8600 collector on port D 8606. When the patient is still hydraulically connected to the dialysis system, physiological saline is allowed to flow, under the influence of gravity or applied about pressure, to the collector 8600 through port D 8606, which is adjacent to port C 8605. The flow of saline is used to clean the collector 8600 with physiological saline and, in particular, to flow out of the collector 8600 through port C 8605, through the tubular segment 8658 and into the body patient through connection 8651. Since the air bubble detector is present in section 8654, near port C 8605, where the collector 8600 is installed in the control unit, and thus configured to detect air bubbles in the fluid flow leaving port C 8605, f the saline flowing from the 8600 collector to the patient will be monitored for air bubbles using an air bubble detector in section 8654. When an air bubble is detected, a warning signal will sound, thus signaling to the patient that he needs to either disconnect from the system or remove air bubble using a syringe from access point 8610. Accordingly, this method and system for conducting backwash with physiological saline solution maintains a sterile compound, while at the same time monitoring and signaling the presence of air bubbles.

Advanced hardware architecture

The dialysis system embodiments disclosed herein may further comprise an equipment architecture that provides a faster way to end the system. Traditionally, when a dial-up alarm condition occurs during dialysis, or if the user wishes to complete the work, instructions issued at a higher level of applications must go through multiple lower levels to actively shut down the equipment. This architecture exposes users to the unnecessary risk of delayed shutdown, which, in important applications, may not be acceptable.

78, a dialysis system comprises at least one processor and a memory for storing program instructions, which, when executed, communicates with application program level 7805. The application level 7805 interacts with the main controller 7810, which is capable of communicating with a variety of user programmable gate arrays, responsible for controlling various pumps, sensors and valves (FPGA control) 7815, and is capable of exchanging data with a number of user programmable gate arrays, responsible for monitoring the operation of various pumps, sensors and valves to identify failure conditions or conditions in which the operating parameters of 7820 are outside the permissible limits (for itnyh FPGA).

The FPGA 7815 controllers execute hardware instructions for controlling the operation of all system components, including pumps, sensors and valves, and for transmitting component status information to the 7810 controller, which, in turn, processes information and transfers certain data for further processing and / or mapping to a level 7805 applications, and to 7820 protective FPGAs that monitor status information to detect warning conditions, for example, when an operating parameter goes beyond one or more predefined threshold values or does not correspond to them.

When the control FPGA 7815 generates data indicating a condition of the warning signal or, in general, indicating the need to complete or suspend operation, the controller 7810 or application level 7805 may issue one or more commands to complete the operation. However, regardless of this, the protective FPGA 7820 receive data and can directly issue commands or otherwise cause the end, pause or other change in the state of operation of one or more valves, pumps or sensors. Protective FPGA 7820s can do this after receiving data directly from the control FPGA 7815 or independently if they receive direct instructions from the 7810 controller or application level 7805. When protective FPGAs directly receive data from 7815 FPGA controllers and instructions from application level 7805 and 7810 controller, without any intermediate level between them, the system can more quickly and reliably shut down, pause, or other state change in accordance with the warning condition or user instructions.

Graphical user interfaces

Embodiments of the dialysis system further comprise interfaces through which users interact with the system. As discussed previously, the control unit comprises a display for presenting a graphical user interface to a user. The interface allows the user to accurately measure and verify prescription additives and provides functionality to verify the integrity and authenticity of consumables used in the system, as well as prescription additives.

As discussed earlier, the dialysis system contains scales that can be integrated on a shelf on top of the control unit, inside the reservoir unit of the portable dialysis system, to the side of the lower unit near the holders for the sorbent or infusate cartridge, or anywhere else. The results of measurements made using a digital scale are displayed through graphical user interfaces (GUIs) shown on the display integrated in the upper control unit.

In one embodiment, the control unit is programmed in accordance with a user recipe. This can be done through an initial setup in which the user places all of the prescription additive packages one at a time on the weighing tray. Measurements made by a digital balance are recorded and stored in the internal memory. Thus, the controller has access to data regarding the names and prescribed weights of additives. Thus, when a package of any prescription supplement is placed on the measuring scale before starting the dialysis process, the controller compares the measured weight with the prescribed weight stored in the internal memory. In the event of any discrepancy between the measured weight and the correct or prescribed weight, the controller instructs the GUI to display a warning signal or instructs the audio signal generation unit to generate an audible warning signal. Thus, such a warning signal may be visual, for example a flashing error message on the GUI screen, and may also be accompanied by an audible warning signal. Alternatively, the user is not allowed to continue the dialysis installation process.

Fig. 79 illustrates an example data table for prescription supplements that may be stored as a file, a uniform file, or a table in the internal memory of a portable dialysis system. Column 7901 indicates the contents of the packet and column 7902 indicates the corresponding weight. As you can see from column 7902, the difference in weight between different packages is several grams, and digital scales allow you to catch it. In one embodiment, the digital scales of the present invention are designed with a weight resolution of the order of 0.1 g, which, given the weight of the additives, provides a more than five-fold resolution advantage and, more preferably, a ten-fold resolution advantage. This resolution is sufficient to distinguish between commonly used additives.

Optionally, the design of the digital scale is such that the weighing process does not depend on how the user places the prescription additive packages on the scale. The fact is that the design of the scales in the present invention contains multiple weight-sensitive parts at multiple points of the suspension. In one embodiment, for example, the balance comprises three sensors at three suspension points. The total weight is calculated by the weighing system as the sum of the weights measured by all sensors. The advantage of using this calculation scheme is that the package weight does not have to be evenly distributed across the weighing platform. Thus, even if the packages are located on the weighing tray with a slight offset to one side, flat or wrinkled, this will not affect the accuracy of measuring the weight produced by the balance. Thus, the user is not presented with any requirements as to how to place packages on the scales.

It is also obvious that the weight of the sensor can be determined using any calculation method known in the art. In one embodiment, a processor capable of exchanging data with the scales receives data received from the scales and determines the weight as follows:

Sensor_Weight (i) = K1 (i) * ADC (reading) + K0 (i)

Bag_Weight = (Sensor_Weight (0) + Sensor_Weight (1) +

Sensor_Weight (2) + Sensor_Weight (3)) / 4

As discussed previously with respect to FIG. 16, the portable dialysis system has an open reader 1605, for example, a barcode reader or RFID reader, which can be used to read codes or labels on prescription additive packages. For the initial installation, the user will preferably scan all codes / labels on the prescription additive packages with the reader 1605. The user can be guided by the initial GUI message that prompts the user to scan each prescription additive package with the reader 1605. After that, the reader receives identification information about additive and transmits this identifying information to an internal table stored in memory. After this initial installation, whenever it is necessary to add a prescription additive to the dialysate before starting dialysis, the identification information of the corresponding package (read by the reader 1605) is compared with the identification information for this additive previously stored in the internal table during the initial installation. This helps to ensure that the correct additives have been selected for use with dialysate and helps to discard any fake additives. The contents of the internal table can be generated either by manually entering data regarding the identity and weight of the additives, or through remote access to a recipe that details the identity and number of additives.

In one embodiment, the GUI of the present invention is generated by a plurality of program instructions stored in memory and executed by a processor present in the control unit. One set of program instructions is intended to help the user carry out the process of verifying the identity and quantity of additives to be used. The first GUI screen prompts the user to scan the barcode on the additive package with a barcode reader. One skilled in the art will recognize that this identification mechanism may be a barcode, RFID tag, or other electronic tag, and the reader may be a barcode reader, RFID reader, or other electronic tag reader. The reader reads the encoded information, processes it using a processor, and transfers the processed information to memory. The memory has a software procedure that converts the processed information into the identity of the additive. In one embodiment, the conversion is performed using a table that maps various identifiers to specific names of additives. This table can be entered manually before the procedure or downloaded from the server via a wired or wireless connection to the controller.

After obtaining the identity of the additive, the ISU transfers the identity of the additive to the user and instructs the user to place the additive on the balance. Digital scales weigh the additive and transfer the measured weight to the second table. The second table compares the identity of the supplement with the expected weight. This second table can be entered manually before the procedure or downloaded from the server via a wired or wireless connection to the controller. If the identity of the additive and the measured weight match, the user is instructed to open the package and pour its contents into the proper place. This process is repeated for all supplements. In one embodiment, the user is not allowed to continue the process if there is a discrepancy between the identity of the packet and its weight, or if the packet identification code is unreadable or unknown. Thus, the system provides a one-step or two-step verification mechanism: a) the use of digital scales on their own, or b) the use of digital scales in combination with a barcode or tag reader, which ensures that the user has all the necessary additives and that the correct additives are used, not counterfeit or unsuitable.

FIG. 80 is a flowchart showing another process 8000 for initiating therapeutic dialysis. In one embodiment, the control unit 8001 comprises at least one processor and a memory where a plurality of program instructions are stored. When executed by the processor, program instructions generate many graphical user interfaces displayed on the controller display that instruct the user to perform a number of actions aimed at reliably obtaining and measuring the additives necessary for use in therapeutic dialysis. A first graphical user interface is generated by which the user can instruct the system to initiate the additive accounting process 8001. The initial prescription can be done through a special icon to initiate the process, or it can be done as part of a larger system installation.

Then, a second graphical user interface is generated 8003, which displays the necessary additives in text or graphic form, preferably including a visual representation of the actual packaging of the additive, so that the user can visually compare the necessary additive with the product at the user's disposal. The user is then prompted to 8005 to indicate whether he wants to test the supplement using a barcode snapshot or by weight. If the user indicates that he wants to use a snapshot of the barcode, for example, by clicking on the icon, a third graphical user interface is generated 8007, instructing the user to scan the first addition with a barcode scanner. The user then scans the additive, preferably in any order, with a barcode scanner, recording the reading result. Obviously, the barcode scanner may contain a light indicator, for example, a red light indicator that changes color, for example to green, in case of successful reading.

If the system successfully reads the barcode, it processes the 8009 code, checking the code against the table stored in memory. A table stored in memory associates barcodes with specific additives. After identifying a particular additive, the second graphical user interface, as described above, is updated 8011 with a check mark or highlight to indicate which additive has been successfully scanned, and the user is instructed to set the additive aside. This process is repeated 8019 for all additives. In one embodiment, when all additives are highlighted or marked, the system automatically proceeds to the next step in the installation or initialization of dialysis. In another embodiment, when all supplements are highlighted or marked, the system presents a graphical user interface that informs the user that all supplements have been registered, after which the user instructs the system to proceed to the next step during the installation or initialization of dialysis. Obviously, while the term barcode is used, any electronic tagging or tagging system can be used.

If a barcode is not recognized at any scanning step 8009, additives do not have barcodes, or the user prefers to check additives using weighing rather than scanning, the user is presented with a graphical user interface instructing 8013 the user to place the first additive on the scale. The balance measures the weight of 8015 additive packages and compares the measured weight with a table of weight values associated with specific additives for recognition of the additive. After recognition, the second graphical user interface, as described above, is updated 8017 with a check mark or highlight to indicate which additive has been successfully scanned, and the user is instructed to set the additive aside. This process is repeated 8019 for all additives. In one embodiment, when all additives are highlighted or marked, the system automatically proceeds to the next step in the installation or initialization of dialysis. In another embodiment, when all supplements are highlighted or marked, the system presents a graphical user interface that informs the user that all supplements have been registered, after which the user instructs the system to proceed to the next step during the installation or initialization of dialysis. Obviously, while the term barcode is used, any electronic tagging or tagging system can be used.

If the supplement is not recognized, the user is informed that the supplement is not part of the treatment process and is asked to weigh the correct additive. In another embodiment, if the user cannot scan or weigh the recognized additive, the user is not allowed to continue the initialization or installation process.

It will be apparent to those skilled in the art that although the above verification procedure has been described for prescription additives, the same procedure can also be extended to disposable components used with the dialysis system, for example, sorbent cartridges and other consumables.

It is also obvious that the process of scanning and weighing additives can be integrated and automated. As discussed above, the user may be prompted to initiate the weighing process of the supplement, and a list of items needed for treatment may be displayed. The user places the additive on the scales equipped with a barcode reader located near them or integrated into them. In one embodiment, the user is prompted to position the additive in a particular position or configuration to ensure proper reading of the barcode. After placing the additive on the scales having an integrated or combined barcode reader, the barcode reader scans the additive, tries to recognize the barcode, and, if successful, processes the item, marking or highlighting the identified additive on the display. If the barcode reader fails to identify the additive, if the system requires an additional, auxiliary check, or if the system wants to obtain or otherwise record the weight information, the scales measure the weight and try to recognize the additives by the stored values. In case of successful identification, the system processes the item, marking or highlighting the identified additive on the display. Thus, measurement with a scale and scanning with a barcode reader can occur without the need to move the additive from one position or position to another.

It is also obvious that additives can be inserted into a holding container, tray, cylinder, box, pallet or loading area, which will automatically dump, place or otherwise position each additive in the proper position on the scales / barcode reader. Accordingly, the user can place all additives in a single container, activate the system, as a result of which each additive is sequentially located on the scales and is automatically identified. The user may be prompted to remove each additive after recognition, or may be asked to first allow all additives to be processed.

It is also obvious that the additive can be added to the system automatically after identification, manually after identification, and before or after installation of the hemofilter and / or sorbent cartridge. In one embodiment, the upper or lower unit of the portable dialysis system also preferably has electronic interfaces, such as Ethernet connections or USB ports, to provide a direct connection to the network, thereby facilitating remote recipe checking, matching control, and other remote maintenance operations. USB ports also allow direct connection with auxiliary products, such as blood pressure monitoring devices or hematocrit / saturation monitoring devices. Interfaces are electronically isolated, which ensures patient safety regardless of the quality of the paired device.

In another embodiment, the dialysis apparatus comprises an interface, in the form of a graphical user interface with touch screen buttons, a physical keypad or mouse that can be manipulated to allow loading of the collector into the dialysis apparatus to begin operating in treatment mode or refueling mode. Having received the order to work in the treatment mode, the controller generates a signal (by the command to switch to treatment mode) to transfer the collector valve from the open charge state to the closed treatment state. Having received the order to work in the refueling mode, the controller generates a signal (according to the mode of switching to the refueling mode) to transfer the collector valve from the closed treatment state to the open refueling state. It will be apparent to those skilled in the art that all of the aforementioned control functions and user instructions are implemented by one or more processors executing programs that implement the aforementioned instructions, which are stored in local memory.

When properly activated, the system can operate, at least in the refueling mode and the treatment mode, which may contain other modes of operation (for example, hemodialysis, hemofiltration, or, more simply, refueling mode). With respect to an exemplary treatment regimen, according to FIG. 84, a dialysis system 8400 operating in a dialysis mode comprises a dialyzer 8402, a sorbent regeneration system 8412 (e.g., cartridge), a collector 8410, an infusate source 8416 entering the collector 8410 through a port, and a reservoir 8415, from which fresh dialysate is introduced back into the 8410 collector through the port. From an operational point of view, blood enters the blood line 8401, into the collector 8410 through the port, through the two-way valve 8421, located in the first position, and into the dialyzer 8402. The purified blood leaves the dialyzer 8402 through the outlet 8403, through the two-way valve 8422, located in the first position, and to the collector 8410 through the port. Blood passes through the collector, passing through a plurality of valves 8417, as described above in connection with the collector 8410, from the port to the blood line 8423 connected to the patient.

At the same time, the infusate passing from the source 8416 enters the collector 8410 through the port, through the collector 8410, through the other port, and into the reservoir 8415, from where the dialysate is delivered through the dialysate input line 8424 to the dialyzer 8402. After passing through the dialyzer 8402, the dialysate passes through the output line 8425 back to the collector 8410 through the port, from where it is sent to the system 8412 sorbent dialysate regeneration through the port. The regenerated dialysate flows back through the collector 8410 through the port and is recycled through the dialyzer 8402 with the new dialysate, if and when necessary. To control the flow of the dialysate, reservoir 8415 is used to store the regenerated dialysate, if and when necessary. In one embodiment, the reservoir holds 5 liters of dialysate and has a capacity to hold up to 10 liters of dialysate and outflow from the patient.

With respect to the exemplary refueling mode of FIG. 85, the dialysis system 8500 operating in the refueling mode comprises a dialyzer 8502, a sorbent regeneration system (eg, cartridge) 8512, a collector 8510, an infusate source 8516, and a reservoir 8515. From an operational point of view, the line blood supply from the patient (for example, 8401 in Fig. 84) to the collector 8510 is not connected, and thus the blood does not flow, and is not able to flow, to the collector 8510. On the contrary, the dialysate passing from the source 8515 enters the collector 8510 through multiple ports and through dialysis input line 8524 one connected to port 8522 of the two-way valve.

In a preferred embodiment, a single two-way valve 8517 is included in the physical body of the manifold 8510 and is manipulated to transition between the operating mode of treatment and the operating mode of refueling, as discussed above. In this embodiment, the manifold 8510 includes a two-way valve 8517, which, if activated or moves from the first position (e.g., closed) to the second position (e.g., open), causes a change in the internal fluid flow path in the manifold. As a result of this change in the flow channel, blood and dialysate pipelines, which, when the valve is closed, are hydraulically isolated from each other, establish fluid communication with each other. Preferably, to achieve this change of state, namely, the establishment of fluid communication of the individual pipelines for blood and dialysate, it is not necessary to manipulate any additional valves or switches.

Switching of the valve can be carried out by any means known in the prior art, including by physically manipulating a mechanical control on the surface of the collector, or electronically, through the operation of the dialysis machine, which leads to a change in the state of the valve, through the interface between the dialysis device, which has a controller for control valve status in accordance with the user selected mode of operation, and a valve interface built into the surface of the manifold.

In charging mode, valve 8517 is open, allowing dialysate flowing through the pump to pass through manifold 8510, into dialyzer 8502 through tubing 8524, 8503 and port 8522 of the two-way valve, from the dialyzer, back to the collector 8510 through port 8521 of the two-way valve and tube 8525, and from the collector 8510. Accordingly, in the charging mode, the valve 8517 ensures that the dialysate circulates through the blood line, which provides a fluid connection of the pipelines for blood and dialysate. From a functional point of view, the manifold 8510 is put into refueling mode by manipulating the state of the two-way valve 8517.

After injection of the indicated volume of dialysate into and through the blood line, the two-way valve closes. Dialysate injection may or may not continue. If it continues, fresh dialysate only circulates through the dialysate line. The remainder of the dialysate remains in the bloodstream. In order to drive the dialysate out of the blood line, the patient is connected to the “from the patient” line 8401 shown in FIG. 84, commonly referred to as the arterial access line. Line 8423 to the patient, usually referred to as the venous return line, is either held above the waste container or connected to the patient.

When the system is in treatment mode, blood from the patient is pumped into the blood line leading to the collector, through pumps, from the collector, through the dialyzer, back to the collector, and back from the collector. Thus, the blood “drives” the remainder of the filling fluid through the blood line, removing any remaining air pockets remaining in the process, either into the waste container or into the patient’s body, depending on the state of the venous return line connection. After the blood line is completely filled with blood, the system stops the blood pump, or the user stops the pump manually. If the venous return line is not yet connected, it connects to the patient and treatment continues.

In another embodiment, a filter, for example a 0.22 μm filter, can be used to help remove all other undesirable substances if the sorbent canister is not capable of producing a substantially sterile dialysate. In one embodiment, the filter is arranged in series with the inlet line of the tank, near the port E of the collector, and is used both during refueling and during operation.

Using this refueling system, you can avoid the need to use additional and separate sets of supplies just to refuel the blood side of the pipeline. In particular, this approach eliminates the need for a separate source of saline solution, for example, a liter package of saline solution, and, accordingly, also eliminates the need for connectors and piping to a separate source of saline solution, including double-lumen tips or single-lumen tips used to connect blood lines to saline solution.

Disposable Kits

The dialysis system embodiments disclosed herein provide for the use of multiple disposable components. 81, in one embodiment, consumables 8106 for use in the system are delivered in a package pre-assembled on tray 8105. Tray 8105 is located on top of the working area of control unit 8101, which simplifies access to and disposal of necessary consumables, which represents Of particular importance to home users. The control unit 8101 is waterproof, therefore, in the event of a spillage of liquid, it will not get inside and will not damage the upper control unit 8101.

In one embodiment, the kit 8200 comprises a pre-connected manifold 8202, a dialyzer 8201 and a pipe 8203. Referring to FIG. 82, a disposable kit 8200 contains a dialyzer 8201, a collector 8202, a pipe 8203, valves 8204 (as part of a manifold), a reservoir package 8205, which all are pre-connected and configured for direct installation in the dialysis machine by the user.

In a more particular case, disposable components, in particular, completely disposable blood and dialysate pipelines, are pre-packaged (which includes a dialyzer, collector, piping, reservoir package, ammonia sensor and other components) and then installed by the user by opening the front upper unit doors (as discussed above), dialyser installation and collector installation in such a way as to guarantee alignment with non-disposable components, such as pressure sensors and other components nents. Many pump pads integrated in the inner surface of the front door make loading of disposable components easier. It is only necessary to insert the manifold, and no pump piping needs to be connected by means of a threaded connection between the rollers and the blocks. This compact, simple approach makes it easy to load supplies and clean the system. It also ensures that the piping is correctly configured and ready for use. From an operational point of view, the upper block is connected to the lower block by a reservoir.

Optionally, disposable components and, in particular, the collector, contain an electronic lock system (“e-lockout”). 83 is a functional block diagram illustrating one embodiment of an electronic lock system of the present invention. In one embodiment, the electronic locking system 8300 comprises a reader 8301 that records and reads identification data 8306 embedded in disposable items 8302, for example, disposable collectors, disposable sorbents used in dialysate regeneration and / or dialyzers. Identification data 8306 can be stored on disposable items 8302 through a barcode, RFID tags, EEPROM, microcircuit, or any other means of identification that uniquely identifies disposable items 8302 to be used in dialysis system 8303. The reader 8301, respectively, is a barcode reader -code, RFID reader, microchip reader, or any other reader that matches the applicable identifier technology an association known to those skilled in the art. In one embodiment, the reader 8301 is connected to a transceiver for wirelessly connecting 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 credentials 8306.

The database 8305, located remotely from the dialysis system, stores information from disposable items 8302 that can be used in the system 8303. The information contains unique identification data 8306 together with information about the corresponding disposable item, for example, authenticity, suitability, in the sense of probability that the item is in working condition, or whether the item was recalled by the manufacturer due to a defect, expiration date, if any, and / or any other additional information that reimuschestvenno obvious to those skilled in the art.

From an operational point of view, when a disposable item 8302, such as a dialyzer, collector, or hemofilter cartridge, is loaded into the system 8303, the reader 8301 registers the disposable item 8302 through the identification data 8306 embedded in the item 8302. This identification data 8306 is read by the reader 8301, which , in turn, communicates, either wired or wirelessly, with the database 8305 to request additional information stored there on item 8302, based on the identification identification data 8306, or confirm the validity or integrity of the item 8302 based on the identification data 8306.

For example, in one embodiment, the dialyzer cartridge 8302 identified by reader 8301 may be recalled by the manufacturer based on any defect. This recall information is stored in the database 8305 and returned to the reader 8301 as a result of the request signal sent by the reader 8301 to the database 8305 via the network 8304. As a result of the recall information received from the database 8305, the microprocessor controls the blood purification system supported by the system 8303, does not allow the user to continue treatment. This is achieved, in one embodiment, by suspending the pumps that drive fluids through the piping of the blood purification system 8303. Additionally, an audiovisual warning signal may also be displayed for this purpose.

In another example, the dialyzer cartridge 8302 identified by reader 8301 may not be genuine. In this case, the microprocessor will not allow the blood purification systems of system 8303 to function. Thus, the electronic locking system 8300 of the present invention prevents the use of system 8303 when disposable items 8302 attached to the collector 8303 are in doubtful condition.

Although it has been illustrated and described that is currently being considered as a preferred embodiment of the present invention, those skilled in the art can propose various changes and modifications, and its elements can be replaced with equivalents without departing from the true scope of the invention. In addition, you can offer numerous modifications to adapt a specific situation or material to the principles of the invention, without going beyond its central volume. Thus, it is contemplated that this invention is not limited to the specific embodiment disclosed as the alleged best mode for carrying out the invention, but that the invention includes all embodiments that fall within the scope of the following claims.

Claims (25)

1. A dialysis apparatus for processing blood in a dialyzer, containing
a. a control unit, said control unit comprising
i. a door having an inner surface
ii. a cabinet with a panel, said cabinet and panel forming a recessed area configured to receive said inner surface of said door,
iii. a collector receiver firmly attached to said panel, said collector receiver being configured to receive a collector through which said blood flows from a patient through a dialyzer, and
iv. a processor for controlling the flow of said blood through a collector and a dialyzer,
b. a base unit, said base unit being configured to physically connect to and disconnect from said control unit and, when connected, be able to exchange data with said control unit, said base unit comprising
i. a flat surface for receiving a liquid container, said liquid container being in fluid communication with said collector,
ii. first scales physically associated with said flat surface, and
iii. a heater in thermal communication with said liquid container,
moreover, the specified processor in the control unit is configured to control the blood flow from the patient through the dialyzer and the collector, which is located in the collector receiver in the housing with access to it through the door, and the processor in the control unit is configured to control the fluid flow from the liquid container through dialyzer and collector. 2. The dialysis apparatus according to claim 1, wherein said panel is configured to provide access to a plurality of pumps. 3. The dialysis apparatus according to claim 1, wherein said collector is a molded plastic base that forms a first flow channel that is hydraulically isolated from the second flow channel. 4. The dialysis apparatus according to claim 1, wherein the balance comprises a plurality of bend sensors and Hall sensors, each of said bend sensors being physically connected to said flat surface, and each of said Hall sensors is configured to record physical displacement. 5. The dialysis apparatus according to claim 1, further comprising a sodium sensor in electrical communication with said liquid, the sodium sensor comprising a conductivity sensor. 6. The dialysis apparatus according to claim 1, wherein the control unit comprises a plurality of sensors associated with said collector when said inner surface of the door is in said recessed region, wherein at least one of said plurality of sensors comprises a pressure transducer or a flow meter. 7. The dialysis apparatus according to claim 1, wherein the base unit comprises a door capable of being in an open state or in a closed state, the door being brought into an open state physically blocked when said inner surface of the door enters a recessed area. 8. The dialysis apparatus according to claim 1, wherein the control unit comprises at least one valve component associated with said collector, said control unit comprising a memory that stores a plurality of program instructions that, when executed by a processor, activate the valve component moreover, the activation of said valve component causes the fluid to flow through one of two separate flow channels into said manifold. 9. The dialysis apparatus according to claim 8, wherein said valve component has an open position and a closed position, said valve component comprising
a. the detail of closing the hole next to the hole through which liquid can flow,
b. an offset member having a first portion and a second portion, said first portion adjacent to the hole closure portion when the valve component is in said open position,
c. a first magnet and a second magnet, said first and second magnets being close enough to said bias part to act with magnetic force on said bias part, and
d. an actuator for generating a magnetic field to move said bias part to said first magnet, to ensure that said first portion is pressed against the hole closure part, and to ensure that said hole is closed by the hole closure part. 10. The dialysis apparatus of claim 9, wherein the hole closure member comprises at least one of a diaphragm, an elastic material, and a compressible material. 11. The dialysis apparatus of claim 9, wherein the hole closure member is pressed against the valve seat to close said hole. 12. The dialysis apparatus of claim 8, wherein said valve component comprises
a. an opening closure member adjacent to an opening through which fluid may flow, said opening closure member being pressed against the valve seat when the valve is in the closed position,
b. a movable part configured to physically move relative to said hole closure part, said movable part moving from a first position when said valve is in an open position to a second position when said valve is in said closed position, wherein in said second position , the movable part is pressed against the hole closing part to ensure that said hole closing part is pressed against the valve seat,
c. a first magnet and a second magnet separated by a gap, said first magnet and a second magnet generating a magnetic field in the gap, said magnetic field having a direction, and
d. an actuator capable of generating electromagnetic force, said electromagnetic force reversing the direction of said magnetic field. 13. The dialysis apparatus according to claim 12, further comprising an optical sensor provided for determining the presence or absence of a gap. 14. The dialysis apparatus according to claim 1, wherein the control unit comprises a disconnection monitor for determining a break in the connection of the blood line to the patient. 15. The dialysis apparatus of claim 14, wherein the disconnect monitor comprises
a. a pressure transducer coupled in pressure to the blood flow passage in said manifold, said pressure transducer generating a signal indicating a pulse signal in said blood flow passage,
b. a cardiac reference signal generator, wherein said cardiac reference signal generator registers and generates a signal indicating said pulse of the patient,
c. a pressure transducer data receiver, wherein said pressure transducer data receiver receives said signal indicating a pulse signal in said blood flow passage,
d. a cardiac reference signal receiver, said cardiac reference signal receiver receiving said signal indicative of a patient's pulse, and
e. a processor, said processor cross-correlating said signal indicating a pulse signal in said blood flow channel and said signal indicating a patient’s pulse to generate data indicative of a disconnection of the blood line from the patient. 16. The dialysis apparatus according to claim 1, wherein said control unit further comprises
a. display,
b. second scales
c. barcode reader, and
d. a memory where a plurality of program instructions are stored, and, when executed by said processor, said instructions generate
i. a first graphical user interface for presentation on said display, said first graphical user interface displaying each supplement necessary for use in therapeutic dialysis,
ii. a second graphical user interface for presentation on said display, said second graphical user interface inviting the user of said system to scan a variety of additives using said barcode scanner, and
iii. a third graphical user interface for presentation on said display, said third graphical user interface inviting the user of said system to measure a variety of additives using said weights. 17. The dialysis apparatus according to claim 1, wherein said control unit further comprises
a. display,
b. electronic reader, and
c. a memory where a plurality of program instructions is stored, and, when executed by said processor, said instructions generate a first graphical user interface for presentation on said display, said first graphical user interface inviting the user of said system to introduce many scan additions using said electronic reader. 18. The dialysis apparatus according to claim 1, wherein the collector comprises a molded plastic base and said molded plastic base comprises a first flow channel and a second flow channel formed therein, said first flow channel and said second flow channel being hydraulically separated by a valve. 19. The dialysis apparatus according to claim 18, wherein said control unit further comprises a memory where a plurality of program instructions are stored, wherein when said processor executes, said program instructions are configured to set a first state of said valve and a second state of said valve depending on the selected operating mode. 20. The dialysis apparatus according to claim 1, wherein said collector comprises a molded plastic base, and said base comprises a first conduit for introducing fluid to the patient and a second conduit for removing fluid from the patient, said control unit further comprising a first pump configured to alternately operate on said first conduit and said second conduit, a second pump configured to operate alternately on said second conduit and said first conduit de, and a controller instructing said first pump to alternately operate on said first conduit and said second conduit and instructing said second pump to alternate operation on said first conduit and said second conduit, wherein each of said first pump and second pump is currently only operating on one pipeline. 21. Dialysis apparatus containing
a. a disposable plastic base comprising a conduit configured to be connected to a patient and containing flow channels for transporting blood from said patient,
b. a dialyzer in fluid communication with said disposable plastic base and adapted to receive said blood,
c. a first block, said first block comprising
i. a door having a first surface
ii. a housing attached to said door, the housing having a second surface,
iii. at least one collector receiver firmly attached to said second surface, said collector receiver configured to physically receive said disposable plastic base,
iv. a display for displaying a graphical user interface, and
v. a processor for controlling the flow of said blood through a disposable plastic base and a dialyzer, and
d. a second block, said second block being configured to physically attach to and disconnect from said first block, said second block comprising
i. at least one flat surface for supporting the liquid container, said liquid container being in fluid communication with said disposable plastic base,
ii. scales combined with said flat surface; and
iii. a heater in thermal communication with said container,
moreover, the specified processor in the first block is configured to control the blood flow from the patient through the dialyzer and a disposable plastic base, which is located in the collector receiver, and the processor in the first block is configured to control the fluid flow from the liquid container through the dialyzer and the disposable plastic base. 22. A dialysis apparatus for processing blood, containing
but. a dialyzer in fluid communication with a disposable plastic base and adapted to receive said blood,
b. first block containing
i. a door with a pressure plate located on the inner surface of the door,
ii. a housing with a panel, said housing and a panel forming a recessed area configured to receive said internal surface of said door, and
iii. a leveling mechanism firmly attached to said panel, wherein said leveling mechanism is configured to detach a disposable plastic base on said panel and place said disposable plastic base opposite said pressure plate when the door enters said recessed region, said disposable plastic base being in fluid communication with a patient, with a sorbent cartridge, with a dialyzer and with a water source, and
iv. a processor for controlling the flow of blood through said disposable plastic base and said dialyzer and for controlling the flow of said water through said disposable plastic base, said sorbent cartridge and said dialyzer,
c. second block containing
i. a flat surface for receiving said water source,
ii. weighing means combined with said flat surface, and
iii. a heater in thermal communication with said container,
moreover, the specified processor in the first block is made with the ability to control the blood flow from the patient through the dialyzer and a disposable plastic base, and the processor in the first block is made with the ability to control the flow of water from the water source through the dialyzer, the sorbent cartridge and the disposable plastic base. 23. The dialysis apparatus according to claim 22, wherein said disposable plastic base is hydraulically isolated from the second flow channel. 24. The dialysis apparatus of claim 23, wherein said disposable plastic base comprises
a. first layer
b. second layer
c. a first flow channel formed by a first surface of the first layer and a first surface of the second layer,
d. a second flow channel formed by a first surface of the first layer and a first surface of the second layer, and
e. a valve in fluid communication with both of said first flow passage and said second flow passage, said valve having a first state and a second state, wherein being in said first state, the first flow passage and the second flow passage are in liquid isolation and being in said the second state, the first flow channel and the second flow channel are in fluid communication. 25. The dialysis apparatus according to claim 23, wherein said molded plastic base is formed by a first segment, a second segment and a third segment,
a. said first segment being parallel to said second segment,
b. wherein said third segment is perpendicular and attached to each of said first segment and second segment, and
c. wherein said first, second, and third segments form a first flow channel that is hydraulically isolated from the second flow channel.

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