RU2587950C2 - Modular apparatus for hemofiltration with interactive control system to input operator instructions - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to medical equipment. Apparatus for treatment of blood comprises a control unit having mounted thereon a blood pumps and a plurality of fluid pumps, blood pump located on blood side of said apparatus and said plurality of fluid pumps arranged on liquid side of said apparatus. Manually replaceable set of panels installed on control box and comprises three individual panels containing a cartridge filter panel having mounted thereon a replaceable filter cartridge, blood panel having mounted thereon blood flow tube and fluid panel having mounted thereon a tube supplying fluid. Control unit comprises a controller adapted to control blood and liquid pumps, and an interactive operator control system comprising an operator interface screen. Controller comprises software adapted to control said apparatus in response to selection instruction input by operator, and with possibility of issuing work instructions to specified device. Interactive operator control system is operable to input an operator command for selecting type of treatment of blood of patient. Disclosed is an alternative version, differing by means of adjustment.

EFFECT: invention provides easy adjustment for various therapeutic procedures.

9 cl, 15 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority according to provisional patent application US No. 61 / 110,852 with the date of registration November 3, 2008, fully incorporated into the present application by reference.

BACKGROUND OF THE INVENTION

[0002] Hemodialysis systems are designed to perform blood therapy procedures, such as Slow Prolonged Ultrafiltration (SCUF), Prolonged Veno-Venous Hemofiltration (CVVH), Prolonged Veno-Venous Hemodialysis (CVVHD), or Prolonged Venous Venous Hemodiafiltration (CVVHDF) . These methods of prolonged renal replacement therapy, also called CRRT, are designed to remove metabolic wastes and excess fluid from the bodies of patients suffering from hypervolemia and in need of support for kidney activity. The currently available apparatus for extracorporeal blood processing often requires inconvenient and lengthy tuning procedures, including cleaning and / or replacing blood and / or fluid tubes to treat various patients and perform various types of therapy. Such procedures may require transferring the device from the bed or from the patient’s room to another location, or replacing the device with a system configured and prepared for specific therapy.

[0003] US Pat. No. 5,910,252 describes an apparatus adapted to carry out various types of blood therapy, and means are provided for selecting one type of therapy for its implementation. The described apparatus is a set of all pumps, tubes, several fluid supply tanks, a container for waste fluid and a filter cartridge required to carry out any selected type of blood therapy.

[0004] US Pat. No. 6,200,485 describes another multi-purpose hemofiltration system, including a kit of a blood filter cartridge, pumps, a fluid reservoir and a spent fluid container, components for comparing the weight of a fluid reservoir and a spent fluid container, and operation controls and pump power in response to comparative weight data during therapy.

[0005] The Prismaflex ™ system sold by Gambro, Lakewood, Colorado, provides a wide selection of CRRT therapies. The system allows the user to select a pre-packaged and assembled kit that includes all components, including a specific adsorber and type of filter membrane, or a surface area of the membrane filter, as well as a pre-connected set of tubes for performing the selected therapy.

[0006] US Patent Application Serial No. 12 / 183,537, Registration Date July 31, 2008 (TRANSV1.024A), describes a modular hemofilter apparatus equipped with removable panels for multiple or alternating blood therapy. The apparatus and system described in the above application provide a flexible treatment system characterized by a panel unit including removable and disposable panels mounted on a control unit of the apparatus body, and where filter adsorbers and / or tube sets mounted on panels can be replaced with filters and / or panels having other tube configurations in order to adapt to various types of blood treatment therapies. The above application is incorporated into this application by reference in its entirety.

[0007] In provisional US patent application No. 61 / 105,703, registration date October 15, 2008 (TRANSVI.025PR), the aforementioned modular hemofiltration apparatus with removable panels is further described, including special and unique panel designs and tube configurations. US provisional patent application No. 61 / 105,712, registration date October 15, 2008 (TRANSV1.026PR), discloses components and features for quick and efficient manual installation and removal of filter panels and filter cartridges by the operator. The foregoing provisional applications are incorporated herein by reference in their entireties, respectively.

SUMMARY OF THE INVENTION

[0008] According to one embodiment of the present invention, there is provided an apparatus for handling selected fluids and / or performing renal replacement therapy in a patient, comprising: a control unit having a blood pump mounted thereon and a plurality of fluid pumps, wherein the blood pump is located on the blood side of said apparatus, and said plurality of liquid pumps are located on the liquid side of said apparatus; a manually replaceable set of panels mounted on a control unit and comprising a filter cartridge panel having a replaceable filter cartridge mounted thereon, a blood panel having blood supply tubes installed thereon, and a liquid panel having liquid supply tubes installed on it, the blood panel and the liquid panel is fastened together with the filter cartridge panel; the blood panel is located on the filter cartridge panel for connecting blood supply tubes to the blood pump after fastening filter cartridge panels with a control unit, and a liquid panel is located on a filter cartridge panel for connecting fluid supply tubes to said liquid pumps after fastening the filter cartridge panel to the control unit; moreover, the control unit comprises a controller configured to control the blood pump and said liquid pumps, and an interactive operator control system comprising an operator interface screen operatively connected to the controller; the controller contains software configured to control the specified device in response to the choice of the input commands by the operator and with the possibility of issuing work instructions to the specified device, and the interactive operator control system is configured to enter the command to select slow continuous ultrafiltration (SCUF), long ven venous hemofiltration (CVVH), prolonged veno-venous hemodialysis (CVVHD), prolonged venous-venous hemodiafiltration (CVVHDF), plasmopher or for therapeutic apheresis, and, during the current patient therapy, for selectively changing the replaceable panel kit, replacing the replaceable filter cartridge without changing the panel kit and / or transition to another type of therapy a patient. According to another embodiment of the present invention, there is provided an apparatus for handling selected fluids and / or performing renal replacement therapy in a patient, comprising: a control unit comprising a blood pump and a plurality of fluid pumps mounted on it, the blood pump being located on the blood side of the apparatus , the specified set of liquid pumps is located on the liquid side of the specified apparatus, the control unit further comprises a controller made with zmozhnostyu blood pump control and said liquid pump and contains an interactive operator having an operator interface screen control system operatively coupled to the controller, and the controller contains software adapted to control said apparatus in response to the selection command input by the operator; a replaceable set of panels made with the possibility of manual installation and removal from the control unit, comprising a filter cartridge panel having a replaceable filter cartridge mounted thereon, a blood panel having blood supply tubes mounted thereon, and a liquid panel having liquid supply tubes mounted thereon moreover, the blood panel and the liquid panel are movably fastened to the filter cartridge panel, the blood panel is located on the filter cartridge panel for connecting blood supply tubes to the blood m after bonding pump cartridge filter panel to the control unit, and the liquid panel is located on the filter cartridge panel for connecting the fluid supply tubing with said liquid pump after the bonding of the filter cartridge panel to the control unit; moreover, the interactive operator control system is configured to automatically sequentially recognize the various configuration steps that must be performed during the setup of the system, including choosing the type of therapy, installing a set of panels, installing a package of liquid, flow parameters and connecting a patient. These and other components, distinguishing features, parameters and advantages of the apparatus and its use will be apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 and 2 are perspective views of a hemofiltration control apparatus, showing a front side and various sides of a set of panels mounted on a control unit body;

[0010] FIG. 3 is a schematic view of a modular apparatus for blood therapy, which shows the configuration of the inner fluid and blood tubes of a panel with three bags of fluid in fluid communication with the tubes;

[0011] FIG. 4 shows the inner surfaces of panels with tubes installed on blood supply panels and fluid tubes, and a central panel connected to them, as well as an installed hemofilter cartridge;

[0012] FIG. 5 and 6 schematically show the components of an apparatus adapted to carry out selected types of CRRT therapy for blood filtration;

[0013] FIG. 7 and 8 schematically show the components of an apparatus for implementing embodiments of plasma separation and plasma treatment;

[0014] FIG. 9A and 9B illustrate text instructions on an operator interface screen for some steps of changing a panel set;

[0015] FIG. 10A and 10B illustrate operator instructions for some steps of replacing a filter cartridge;

[0016] FIG. 11 illustrates one screen with instructions for the operator to temporarily disconnect the patient during therapy, and restart the session later;

[0017] FIG. 12 illustrates instructions for an operator to change a packet;

[0018] FIG. 13A-13F and 15A-15C illustrate several operator interface setup screens and sequential setup steps; and

[0019] FIG. 14A-14C illustrate fluid flow screens and alert adjustments.

DETAILED DESCRIPTION OF THE INVENTION

[0020] FIG. 1 and 2 show a design for hemofiltration, comprising a control unit housing 10 with a touch screen operator interface 11, illustrating opposite side views from the front corners of the apparatus. In FIG. 1, the blood side is shown with the rotor of the blood pump 14 visible through an opening in the blood panel 12. FIG. 2 three rotors of the liquid pumps 17, 18, 19 are visible through the inspection openings in the liquid panel 20. The filter cartridge panel 16 with the installed hemofilter 25 is shown in front. The hemofilter, which is removable, is fastened to the front panel with the filter cartridge belt 27 passed through the slots in the front panels. The belt can be conveniently equipped with contact adjustable fastening components, such as Velcro®, which makes it easy to fasten filter cartridges of various sizes. In another embodiment, the contact surfaces of the hemofilter and the front panel may be provided with contact attachment means. The panels of the panel set are mounted on the housing of the control unit with the help of distinctive features and components, which will be further described below. In FIG. 1 shows an air detector 15 and a clamp of a return line 13, and in FIG. 1 and 2 also show liquid bags 21, 22, 23.

[0021] FIG. 3 and 4 show the inside of a three-panel set, where the tubes are mounted on or adjacent to the inner surfaces of the panels, as well as the placement of the tubes thus arranged for connection to a blood pump and liquid pumps, respectively. Also shown are the connections of tube sections or segments to each other, with a filter cartridge, a fluid pressure transmitter, a fluid supply container, and an exudate bag, as well as cannulas or catheters for directing blood to or from the patient's body.

[0022] The blood panel 12 includes blood supply tubes located along the inner, substantially flat surface of the panel. A curved upwardly bent U-shaped bend 49 of the blood supply tubes is connected to the rotors of the blood pump 14 when the blood panel is tightly mounted on the control unit body. Three pressure transmitters 41, 42, 43 are placed on the blood panel, through which various sections of the blood supply tubes pass. The end of the blood inlet line 30 is attached to a patient access device, such as a cannula needle or catheter 52, and includes a clip to close the blood supply tubes. The blood pump 14 (FIGS. 1, 3) pumps blood through the blood inlet line 30 of the blood supply tubes from the patient to the filter cartridge 25 using the blood inlet adapter 29. Blood return line 32 attached to the opposite end of the filter cartridge using the blood return adapter 31 includes segments guiding the return line through the pressure transmitter 42 to the needle cannula and / or catheter 53. Each pressure transmitter has a pressure signal cable attached to the plug of the transmitter 45, which is inserted into the connector on the control unit housing, and use mine to monitor pressure signals from the respective pressure transmitters along the segments of the blood inlet and return lines.

[0023] The liquid side of the apparatus includes a liquid panel 20 with tubes arranged along a substantially flat inner surface. The fluid tubes are adapted and have a suitable shape for connecting the stirrup with liquid pumps 17, 18, 19 attached to the control unit. Similar to the configuration of the blood supply tubes, three curved or U-shaped segments 46, 47, 48 tubes are provided for connecting to the rotors of the respective liquid pumps in order to transfer the fluids through the tubes. Different tube segments and liquid-fluid pumps working together direct the dialysate, fluid replacement, saline / anticoagulant, depending on the apparatus and configuration of the blood treatment, and the exudate or waste from the filter into a container or exudate bag. In particular, the replacement fluid line 38 directs the replacement fluid from the replacement fluid bag 21 through the bent section 46 of the blood inlet line 30 tubes and to the upper end of the filter cartridge 25. The second fluid tube line 34 directs the dialysate from the dialysate bag 23 to the side of the cartridge 25 filter through a curved section of 47 tubes. A third section of fluid tubes directs the exudate from the filter cartridge to the exudate bag 22 through a curved section of 48 tubes. The pressure transmitter 44 is also located on the liquid panel. In a preferred embodiment, all pressure transmitters are located on the respective panels, so that when the panels are tightly mounted on the control unit housing, the pressure transmitters are at the same vertical height, so that accurate pressure data can be removed and compared without the additional adjustment that was required would otherwise be used to compensate for differences in transmitter heights. More precise and detailed descriptions of the configuration of the tubes on the respective blood and fluid panels are described and shown in the aforementioned US patent application Serial No. 12 / 183,527 (TRANSVI.024A), and in US provisional patent application No. 61 / 105,703 (TRANSVI.025PR).

[0024] A three-panel set is manually mounted on the control unit body, and the panels engage with clamps attached to the body and are held by friction forces. In FIG. 1 and 2, the mounting clamps of the panels 56, 58 on the respective sides of the control unit body are spring-loaded so that they pass through the slots 62, 64 on the corresponding blood and fluid panels, and these holes must be fitted to the mounting clamps (see Fig. 1, 2, 4). The clamps are molded to provide a beveled flange passing through the section with the hole, and the flange is pressed against the edge of the hole against the operation of the clamp spring, thereby loading the spring. The clamps are self-locking and snap into place when the sides open a hole. To remove the side panels, the operator manually takes each clip with the charged spring to the side until it is released and becomes able to pass through the hole. The front panel 16 is fitted to two protruding studs or hooks or suspensions 55, 57, each of which is equipped with an enlarged button or side along the edge, as well as a smaller rod. The holes on the front panel are molded, with an enlarged hole port and a narrow hole slot. When installing the front panel, the operator adjusts the ports of the holes to the enlarged studs, presses the panel to the body, because of which the studs pass through the ports of the holes, and the rods enter the smaller slots of the holes. The operator then snaps the blood and fluid panels into the installation position using the above installation clamps, which interact with the panels in the desired positions. Thus, you can easily and quickly install and remove panels manually. Further description of the installation components and procedure is given in provisional patent application US No. 61/105,712 with registration date October 15, 2008 (TRANSVI.026PR), the description of which is incorporated into this application by reference in its entirety.

[0025] Referring to FIG. 5 and 6, schematic components of an apparatus configured to implement selected CRRT blood therapy procedures are illustrated as described in paragraph [0002]. In FIG. 5 shows the configuration of a CVVH apparatus for removing solutes by convection and removing liquids by ultrafiltration. A hemofilter membrane separates plasma water by ultrafiltration, and the replacement fluid from the container 21 is pumped into the bloodstream using a pump 17. The replacement fluid makes up for the selected solutes lost due to convection. The concentration of unwanted solutes decreases as treatment progresses, and the desired solutes are replaced in concentrations maintained at an appropriate level. The removed solutes are sent to waste bag 22 through exudate pump 19. The apparatus shown in FIG. 5 can be used to perform SCUF to remove excess fluid from the patient’s body exclusively by ultrafiltration. When implementing SCUF, no replacement fluid or dialysate is used, and the apparatus shown is modified by removing the replacement fluid bag 21 and not using the pump 17.

[0026] The apparatus configuration shown in FIG. 6, can be used to implement CVVHD and CVVHDF. CVVHD removes solutes by diffusion and removes fluid from the patient's body by ultrafiltration. No replacement fluid is used to perform CVVHD, a replacement fluid bag 21 can be removed, and a pump 17 is not used. However, both CVVHD and CVVHDF use a dialysate liquid, which is sent to the hemofilter 25, and unwanted solutes flow from the blood through the membrane in the filter, and into the dialysate liquid by diffusion. To implement CVVHDF, the replacement fluid is pumped into the blood stream line from the replacement fluid bag 21. The replacement fluid may be introduced into the blood stream upstream of the filter, as shown, or it may be introduced into the return flow line downstream of the hemofilter 25.

[0027] When performing the above types of therapy, an anticoagulant, such as heparin, citrate or another anticoagulant, can be added to the replacement fluid, or it can be introduced into the blood line from the patient, upstream of the hemofilter, using a syringe, pump, or other fluid injection apparatus. Plasma and / or albumin can also be added to the filtered blood returned to the patient’s body, also using a suitable component of a fluid delivery device (not shown).

[0028] The system and apparatus described in this application can be adapted not only for four types of renal replacement therapy and continuous fluid handling for continuous renal replacement therapy (CRRT), but also for separating plasma from blood and treating plasma to remove toxins and excess fluid, as well as for therapeutic apheresis, as will be described below. The apparatus shown in FIG. 7 and 8, illustrates system configurations for plasma separation, plasmapheresis, plasma replacement, maintenance of liver function, and therapeutic apheresis. In the configurations shown, the plasma separator 40 replaces the hemofilter 25 shown in FIG. 5 and 6. Plasma is separated from the patient’s blood and then discarded and replaced, or the plasma is treated to separate and remove and / or neutralize selected pathogenic components or other poisons, toxins, drugs, etc. In FIG. 7 shows a system adapted to effect plasma substitution. Blood from the patient is pumped into the plasma separator cartridge 40, which separates the plasma on the cartridge membrane. The separated plasma is pumped into the plasma waste bag 22 using a pump 19, and the replacement plasma from the plasma infusion bag 26 is pumped by the pump 18. Anticoagulant and saline pumps are also shown. The anticoagulant and / or saline from packet 24 can be introduced into the blood through a plasma separation cartridge or upstream of it.

[0029] FIG. 8 shows an embodiment of an apparatus for processing separated plasma for performing selective plasma treatment. Such selective plasma treatment is called therapeutic apheresis, and it includes an apparatus configured to selectively remove pathogenic components such as toxins, antibodies, proteins, pathogens, including bacteria, viruses, etc., as well as to remove or neutralize drugs, poisons or other selected chemicals. As shown in FIG. 8, the separated plasma is supplied to a plasma selective treatment apparatus or therapeutic apheresis apparatus 50 through a plasma pump 19 to process the plasma. The plasma processing apparatus may comprise plasma substitution components, centrifugal filters or membrane separation filters, cascade membranes and adsorbers or membranes and multiple filtration adsorbers, one or more absorbent cartridges capable of absorbing certain pathogenic components or preparations, and activated carbon cartridges. Other examples of the selective removal of components include specialized adsorbers, including components such as cross-linked polyvinyl alcohol beads or microporous cellulose beads to remove certain amino acid or antibody ligands, components that are capable of chemically treating the plasma to isolate heparin, amino acid salts, or to efficiently neutralization of drugs, poisons or pathogenic components in plasma. The device can also be used to maintain liver function. In addition, the apparatus for selective plasma treatment can combine various components of the plasma treatment, used in series or in parallel for the simultaneous or sequential implementation of several types of plasma treatment or therapy. The treated plasma is sent to the patient’s body via line 33 connected to the blood return line 32. If desired, the apparatus can be equipped with a fourth liquid pump for pumping the processed plasma into the return line or into the exudate container. An additional liquid pump 18 is shown for transferring liquid waste from the apparatus for selective plasma treatment 50 to the bag 51 for waste. An additional description of the apparatus for the selective removal of components and related technologies is given in US Pat. No. 6,849,183, the applicable parts of which are incorporated herein by reference, and in Therapeutic Apheresis Volume 1, No. 2, May 1997, pp. 135-146. . Other examples of such cartridges or plasma substitution components, filters, etc. are disclosed in US Pat. No. 5,605,627, the applicable parts of which are incorporated herein by reference. The apparatus for selective processing of plasma can be performed with providing the operator with the ability to replace, swap or modify the configuration of filters, adsorbers, cartridges, etc., to implement various types of processing of the patient's plasma, if there is such a desire.

[0030] One characteristic feature of the embodiments of the apparatus and system described herein is the possibility of interactive operator control. This feature may include an operator interface that provides work instructions, as well as displaying the status of therapy and its parameters. In the embodiment described below, the interface is a touch screen interface. However, other well-known interfaces may also be used, for example, using conventional buttons or switches.

[0031] The input device used in the present invention may be, for example, a keyboard, trackball, mouse, voice recognition system, or other device configured to transmit information from a user to a computer. The input device may also be a touch screen associated with the display, in which case the user responds to requests on the display by touching the screen. The user can enter text information using an input device, such as a keyboard or touch screen.

[0032] In the present description, the instructions mean the steps of processing information in the system entered into the computer. The instructions may be included in software, ROM programs, or hardware, and include any kind of programmable step carried out by system components.

[0033] A local area network (LAN) or wide area network (WAN) may be a corporate computer network including access to the Internet, to which the computers and computing devices that make up the system are connected. In one embodiment, the LAN conforms to the industry standard TCP / IP protocol.

[0034] In the present description, media refers to images, sounds, videos or any other kind of multimedia data input into the system.

[0035] The microprocessor may be any known general purpose single or multi chip microprocessor, such as Pentium®, Pentium® Pro, 8051, MIPS®, Power PC®, or ALPHA® processors. In addition, the microprocessor may be any known specialized microprocessor, such as a digital signal processor or graphics processor. A microprocessor typically has address lines, data lines, and one or more control lines.

[0036] The system consists of various modules, described in detail below. As will be clear to a person skilled in the art, each of these modules includes various subprograms, procedures, definition operators, and macros. Each of the modules is usually compiled separately, and combined into one execution program. Thus, the following description of each of the modules is used to conveniently describe the functions of the preferred system. That is, processes that are started by certain modules can be freely redistributed to one of the other modules, combined into one module, or provided in, for example, a common dynamically loaded library.

[0037] The system can be used with various operating systems, such as LINUX, UNIX, or MICROSOFT WINDOWS®.

[0038] The system can be written in any known programming language, such as C, C ++, BASIC, Pascal, or Java, and run on a known operating system. C, C ++, BASIC, Pascal, Java, and FORTRAN are industry standard programming languages, and you can use many commercially available compilers to create executable code for them.

[0039] The invention disclosed in this application can be made in the form of a method, apparatus, or finished product using standard programming techniques or engineering techniques for producing software, ROM programs, hardware, or any combination of these products. The term "finished product" in the present description refers to a code or logic program executed on a hardware level or read by a computer from storage media, such as optical storage devices, and volatile or non-volatile storage devices. Such hardware may include, but is not limited to programmable gate arrays (FPGAs), specialized chips (ASICs), complex programmable logic integrated circuits (CPLDs), programmable logic arrays (PLAs), microprocessors, or other similar processing devices.

[0040] The operator control system allows the operator to select a therapy for a patient and change the type of therapy during the current therapy session. The interactive operator control system is also distinguished by providing step-by-step instructions for the operator to selectively replace the bag with the liquid, change the set of panels, replace the filter cartridge, temporarily disconnect the patient and resume therapy later, and all these actions can be performed during the current therapy session with the patient. The control unit of the apparatus includes a controller associated with software configured to provide the above work instructions using text or graphic messages that appear on the operator interface screen. The interface module works thanks to the processor inside the device, and scans user input from the touch screen. If the interface module detects user input, it launches instructions corresponding to the activated indicators on the touch screen.

[0041] FIG. 9A-12 show various screens explaining to the operator the steps that need to be taken to change the package, set the panels, replace the filter, disconnect the patient to complete therapy, or change the therapy during the current therapy session. Access to these instructions is carried out by pressing the "Work" button on the screen, and then selecting the desired bookmark.

[0042] Referring to FIG. 9A and 9B, examples of successive operator interface screens are shown illustrating instructions provided to an operator for changing a panel set. The screen shown in FIG. 9A, includes a Change Set indicator button, which the operator can click or activate to provide instructions for changing a set of panels, including a filter. In one embodiment, when the Change Set button is pressed by an operator, the controller is instructed to stop all pumps and display the first screen shown in FIG. 9A, and providing instructions for the implementation of the step "Return of blood." A blood return will not be performed if blood clots are present in the tubes or filter. The blood return phase can be skipped by clicking the "Next" tab on the screen.

[0043] After the blood is returned, or the stage is skipped, the patient is completely disconnected from the system, and the apparatus is ready to remove the panel set according to the instructions shown in FIG. 9B. After disconnecting the set of panels, the operator presses the "Next" button again, and the instructions for "Unloading the set" (not shown) are displayed on the screen. A set of panels is unloaded by pressing the "Unload" button, unfastening the panel clamps and pulling on the side panels while the pumps are turning. The “Upload” indicator can be pressed several times. The panels removed from the system can be discarded.

[0044] In order to replace only the filter, without replacing the set of panels, click on the "Change filter" indicator button. All pumps are stopped and the blood return screen shown in FIG. 9A, with instructions to help the operator go through the blood return step before the old filter is disconnected from the apparatus. Again, if blood clots are present in the tubes or filter, the blood return step is not performed. In FIG. 10A shows instructions for disconnecting a patient and removing the old filter. To fill a new filter, the patient must be disconnected from the system. When disconnecting an old filter, clamps are used to clamp all the lines connected to the filter. The lines are aseptically disconnected, the old filter is removed, the new filter is attached, and then the lines are wrung out. After that, the operator presses the “Next” button to go to the filling step (not shown), and the system reconnects with the patient following the steps on the screen shown in FIG. 10B. After the patient is connected, the operator presses the "Next" button, and therapy automatically resumes.

[0045] To disconnect a patient during a therapy session, the operator can press the Temporary Disconnect indicator button to temporarily disconnect the patient during therapy, and restart the session later. After the indicator is pressed, all pumps are stopped and the “Blood Return” screen shown in FIG. 9A. The instructions help the operator go through the blood return phase before the patient is disconnected as described above. Return line instructions are shown in FIG. 11. The system also provides instructions for recycling and optional flushing (not shown). After an optional flushing, the screen shown in FIG. 10B instructions for reconnecting a patient. After the patient is reconnected, treatment can be resumed.

[0046] The cessation of therapy is carried out by pressing the "Cessation of therapy" indicator on the touch screen of the operator interface by the operator. After the indicator is pressed, all pumps stop and the blood return screen shown in FIG. 9A. Again, if blood clots are present in the tubes or filter, blood is not returned to the patient, and instructions are displayed for completely disconnecting the patient from the device in accordance with the steps shown in FIG. 9B. Then, after clicking on the “Next” indicator, instructions are displayed for disconnecting the panel set and filter in accordance with the steps shown in FIG. 9B and 10A. After that, the system provides the operator with a choice: exit the program or restart it.

[0047] FIG. Figure 12 shows the Change Package screen, which can be called up to change the package during a therapy session. If a notification or warning about a package is activated, the control system automatically activates a button for the specified package. If there is no notification, then the package change button can be pressed manually, or the system automatically activates the button when the package is removed from the hook. After the packet is replaced, the fluid line is pressed and the packet button on the screen is pressed, the system automatically resets alerts and resumes patient treatment.

[0048] The above procedures and steps may be performed at any time during the current therapy session. Access to the above-mentioned procedures and steps during the current therapy session is carried out by pressing the button or the “Work” tab on the operator interface screen. Such a bookmark or button is displayed on the screen during the entire treatment therapy session. After clicking the bookmark or the "Work" button, the screen will display the other above procedure, including changing the package, changing the set, changing the filter, temporarily disconnecting and completing the therapy, as described above. The current therapy session may also be stopped at any time, and another type of therapy may be started. This can be done by pressing the “Select a stop or a new therapy” button by the operator, see FIG. 9A, after which the operator interface screen shown in FIG. 13A, which allows the operator to select a new therapy. Again, all consecutive screens for each consecutive executed step are automatically displayed when the operator clicks the Next tab or another tab indicating the completion of the steps shown on the screen.

[0049] The operator control system in this apparatus is further characterized by automatic serial recognition of the various configuration steps performed by the operator during system setup. In FIG. 13A, various configuration steps are shown on the left side of the operator interface screen. These steps are performed in series or sequentially, from top to bottom, and they include selecting the type of therapy, installing a set of panels, installing a bag of liquid, setting flow parameters, and connecting a patient.

[0050] Starting from the first tuning step to be performed, the choice of the type of therapy is shown in FIG. 13A, where the operator selects the desired therapy by clicking on the appropriate therapy tab. After selecting a therapy, the screen shown in FIG. 13B prompting the operator to verify that the hooks or suspensions of the bags are free of any tubes or bags, after which the operator presses the OK button to continue the procedure. The next screen shown in FIG. 13C appears automatically and asks the operator to enter the patient identification number, weight and hematocrit, after which the operator presses the “OK” button again to go to the next step in the set-up, the instructions for the implementation of which are shown sequentially in FIG. 13D and 13E. In one embodiment, the panel sets and filter cartridges are provided with strip codes, and the control unit includes a component scanning the strip codes to make sure that the installed set of panels is suitable for the selected treatment method. After scanning the panel set, as shown in FIG. 13D, a new screen (not shown) prompts the operator to scan the filter cartridge used during treatment, and then press the Scan indicator to scan the strip code, or enter it manually. The next preparation step for installing and loading the panel kit is provided with the instructions shown in FIG. 13E. The operator manually installs the side panels and the front panel on the control unit body, and attaches four pressure transmitters to the control unit by connecting the transmitter plugs to the corresponding sockets on the control unit. A waste bag (usually 2 l) is connected to a liquid exudate line. Certain tubes for connecting various bags to a liquid can be color coded. After the panel set is installed, the operator clicks on the “Download” tab and the control unit rotates the pumps to complete the loading of the panels, including connecting the tubes to the pump rotors.

[0051] The screen shown in FIG. 13F, for the setup step of installing the kit, asks the operator to attach a hemofilter and attach fluid tubes (lines) to the filter. Depending on the chosen therapy, the lines of the replacement fluid and dialysate are attached, after which the necessary bags with the fluid, exudate, replacement fluid and dialysate are hung. The bags are hung on hooks or suspensions (see Figs. 1 and 2), and the tubes are attached to the bottom of the bag (see Fig. 3). Preferably, the exudate bag is hung so that the tube enters the bag from above. In one embodiment, well-made hooks or suspensions are used, shown and described in US provisional patent application No. 61 / 105,711 with a registration date of October 15, 2008 (TRANSVI.027PR), the disclosures of which are incorporated herein by reference in their entirety.

[0052] Despite the fact that this is not shown in the drawings, screens are automatically and sequentially displayed after installing the packages and are intended to perform the tasks of filling the system, setting the current speed, setting alerts and connecting the patient to the device. Flow parameters are set on the setup screen shown in FIG. 14A, which is automatically displayed after completion of the system fill step. The operator enters the desired current velocity, presses the "Enter" button, and confirms the correctness of the current velocity using the screen shown in FIG. 14B. In one embodiment, the alert limits can also be confirmed or adjusted, as shown in FIG. 14C. After performing these steps, the operator interface screen automatically returns to the patient connection screens shown in FIG. 15A and 15B, and after the patient’s connection is completed, the control unit enters the operating state when the operator presses the “Start therapy” button. In one embodiment, a status screen, such as that shown in FIG. 15C may be displayed during the entire treatment session.

[0053] As described above, another distinctive feature of the apparatus and system described in this application is the ability to switch to another type of CRRT therapy during the current therapy session, without changing the set of panels and without changing the hemofilter, if it is suitable for use with selected new therapy. In one embodiment, in order to change the type of therapy during the current therapy session, the operator clicks on the corresponding button on the screen, accessing the screen for completing the current therapy session, exiting therapy mode, selecting a new therapy, or another indicator or tab that allows you to restart the program collateral (see, for example, FIG. 9A). Such a procedure may require disconnecting the patient during the setup steps as described above. However, changing the panel set and filter is not required again.

[0054] In another embodiment, another type of therapy may be started by manipulating the apparatus without requiring the complete sequence of the start-up phase. For example, if the replacement fluid bag is installed in the SCUF configuration for infusion of the dissolved anticoagulant, switching from SCUF to CVVHF can be accomplished by increasing the rate of replacement fluid infusion to a suitable higher value. Other examples of current therapy changes include: switching from CVVHF to SCUF or from CVVHDF to CVVHD by changing the flow rate of the CWHF replacement fluid to zero; transition from CVVHD to CVVHDF by installing a replacement fluid package and adjusting the flow rate of the replacement fluid to an appropriate therapeutic level. To implement such changes, the control software may be provided with instructions to the operator on such manipulations with the apparatus, installation and connection of the replacement fluid bag, etc., as will be appreciated by a person skilled in the art.

[0055] In one embodiment, setup steps during system setup, as described above, are denoted by different identifiers in the setup steps. For example, the completed configuration step is indicated by the first identifier, the current configuration step is indicated by a second, different from the first identifier, and each configuration step, which remains to be completed, is indicated by a third identifier different from the first and second identifiers. Such a feature can be implemented by using various indicators marking various tuning steps, for example, completed tuning steps can be circled in solid lines, the current tuning step can be recognized by flashing or dashed lines, and future tuning steps can be circled differently or completely not circled. In another embodiment, the identifier of the setup step may be expressed in different colors, for example, completed setup steps may have a green background, the current setup step may be displayed on a yellow background, or against a color other than the background color of the completed steps, and steps that are yet to be perform, may be indicated in a third color, or not differ in color from the background of the operator screen, on which the tasks to be performed are indicated. Other identifiers may be used to perform this function.

[0056] The embodiment of the setup step described above is characterized by sequential steps performed and displayed on the screen of the operator interface essentially throughout the system setup, and sequential setup steps and tasks for the corresponding step are automatically displayed in response to the operator’s signal that the tasks of the current setup phase. In such an embodiment, the operator can concentrate on completing and confirming the completion of the tasks shown on the screen for the corresponding setup step, and the operator needs to click on a bookmark or button on the settings screen only to confirm completion of the tasks displayed on the screen.

[0057] Summing up, it should be noted that the apparatus and system described above allow the operator to change the type of therapy, the set of panels and / or filter cartridge, packages, as well as stop the therapy, temporarily disconnect the patient and restart the therapy during the current therapy session. The interactive operator control system also provides step-by-step instructions for implementing the above procedures. The operator control system also features automatic sequential recognition of the various configuration steps that the operator needs to carry out, including displaying a list of configuration steps and identifying completed, current and upcoming configuration steps. The screen of the setup phase also clearly indicates the tasks that the operator needs to perform at the various stages of the setup and, in response to the signal from the operator to complete the tasks displayed on the screen, automatically recognizes the next setup step and the sequential tasks that need to be performed. Although specific instructions for selecting and implementing the plasma treatment methods described with reference to FIG. 7 and 8, not shown in the drawings, a similar method of operation is included in the scope of the system described above, as will be appreciated by those skilled in the art.

[0058] It is also necessary to understand that the specific text, sequence, and contents of instructions to the operator shown in the drawings and described in this application are provided only as an illustration and example, and the apparatus, systems and operation thereof are not limited to these examples.

Claims (9)

1. Apparatus for the implementation of blood therapy, containing:
a control unit having a blood pump and a plurality of liquid pumps mounted thereon, wherein the blood pump is located on the blood side of said apparatus, and said plurality of liquid pumps are located on the liquid side of said apparatus,
a manually replaceable set of panels mounted on a control unit and comprising three separate panels configured to be manually installed on the control unit and to be manually removed from this control unit, said panels comprising a filter cartridge panel having a replaceable filter cartridge mounted thereon a blood panel having blood supply tubes installed thereon and a liquid panel having liquid supply tubes installed thereon,
moreover, the control unit comprises a controller configured to control the blood pump and said liquid pumps, and an interactive operator control system comprising an operator interface screen operatively connected to the controller,
the controller contains software configured to control the specified device in response to the choice by the operator of the input commands and with the possibility of issuing work instructions to the specified device, and
the interactive operator control system is configured to enter a command by the operator to select slow continuous ultrafiltration (SCUF), continuous veno-venous hemofiltration (CVVH), continuous venous-venous hemodialysis (CVVHD), continuous venous-venous hemodiafiltration (CVVHDF), plasmapheresis or therapeutic apheresis and also, during the current therapy in a patient, for selective change of a replaceable set of panels, replacement of a replaceable filter cartridge without changing a set of panels and / or switching to another type of tera FDI in a patient. 2. The apparatus of claim 1, wherein the controller software is configured to display step-by-step instructions on the operator interface screen that the operator must follow to change the panel set, replace the filter cartridge without replacing the panel set, and switch to another type of therapy without replacement set of panels or filter cartridge. 3. The apparatus according to claim 2, containing separate suspensions for hanging packages with liquid, interacting with the control unit, and a lot of packages with liquid, interacting with the fluid supply tubes, and the interactive operator control system is additionally configured to provide step-by-step instructions for the operator to replace a bag of liquid during ongoing therapy in a patient. 4. Apparatus for the implementation of blood therapy, containing:
a control unit comprising a blood pump and a plurality of liquid pumps mounted on it, wherein the blood pump is located on the blood side of said apparatus, said plurality of liquid pumps is located on the liquid side of said apparatus, the control unit further comprises a controller configured to control the blood pump and said liquid pumps, and contains an interactive operator control system comprising an operator interface screen operatively connected to the controller, and the controller contains software configured to control the specified device in response to the choice by the operator of the entered commands,
a replaceable set of panels comprising three separate panels configured to be manually installed on the control unit and to be manually removed from this control unit, said panels comprising a filter cartridge panel having a replaceable filter cartridge mounted thereon, a blood panel having blood supply tubes thereon, and a liquid panel having liquid supply tubes installed thereon,
moreover, the interactive operator control system is configured to automatically sequentially recognize the various configuration steps that must be performed during the setup of the system, including choosing the type of therapy, installing a set of panels, installing a package of liquid, flow parameters and connecting a patient. 5. The apparatus according to claim 4, wherein said various configuration steps are sequentially recognized and displayed on the operator interface screen, said operator control system being configured to display on the operator interface screen sequential tasks that the operator needs to perform at the current configuration stage shown in specified screen. 6. The apparatus of claim 5, wherein each completed step of said tuning steps is indicated by a first identifier, the current tuning step is indicated by a second identifier other than said first identifier, and all tuning steps to be performed are indicated by a third identifier different from the first and second identifiers indicated, respectively. 7. The apparatus according to claim 6, in which successive tasks that must be performed at the current setup stage and which are indicated by a second identifier are displayed on the operator interface screen until the operator signals the operator control system to complete the tasks for the specified current stage settings, and, in response to the specified signal, the specified control system is configured to automatically display sequential tasks that must be performed on the next sequentially recognizable Hinnom configuration step shown on said screen. 8. The apparatus according to claim 5, in which it is possible to display the screen of the operator interface of the indicated sequential tasks that must be performed on one or more consecutive display screens, each of which contains a touch switch or button indicating completion of the tasks shown, and in response at the touch of a switch or button, it is possible to automatically display the next consecutive display screen. 9. The apparatus of claim 4, wherein the operator interface screen comprises a touch switch or button for accessing a system operation screen that recognizes operator-entered commands for selectively changing a set of panels, replacing a filter cartridge, changing fluid packets and leaving the current therapy session and starting a new therapy session during the current therapy session.

Images