HK1237693B

HK1237693B - Vehicle

Info

Publication number: HK1237693B
Application number: HK17111973.9A
Authority: HK
Inventors: M·多伊尔; L·塔嫩鲍姆; J·唐
Original assignee: 森尤斯医疗保健集团
Priority date: 2013-03-15
Filing date: 2017-11-16
Publication date: 2020-12-31

Description

Transportation

(This application is a divisional application of an application filed on March 12, 2014, with application number 201480016189.1, and entitled “Autonomous Vehicle Including Extracorporeal Blood Therapy Machine”)

Technical Field

The present invention relates to autonomous vehicles and machines and systems configured to perform extracorporeal blood treatment therapies.

Background Art

As vehicles move toward increasingly autonomous operation, vehicle operators are increasingly freer to perform tasks and focus on matters other than driving the vehicle. While portable dialysis machines are known, there are no vehicles equipped with dialysis machines that are connected to the vehicle's navigation system or autonomous vehicle control systems.

Summary of the Invention

According to one or more embodiments of the present invention, an autonomous vehicle is provided, comprising an autonomous vehicle control system, a dialysis machine, and an interface for providing electrical communication between the dialysis machine and the autonomous vehicle control system. The vehicle may comprise a motor vehicle, a hybrid vehicle, an airplane, a train, a submarine, a helicopter, a ship, a boat, an aircraft, or any other vehicle. The dialysis machine may be configured to perform dialysis treatment on a patient while the autonomous vehicle is under the control of the autonomous vehicle control system. The autonomous vehicle may comprise at least one battery for powering one or more components of the autonomous vehicle, and the interface provides electrical communication between the at least one battery and the dialysis machine. The autonomous vehicle may further comprise a vehicle electrical system, and the dialysis machine may be hardwired to the vehicle electrical system. The autonomous vehicle control system includes an input device by which a user can input a desired destination. The autonomous vehicle control system may be configured to calculate the amount of time required for the autonomous vehicle to reach the desired destination. The dialysis machine controller unit may include an input device by which a user can input a desired prescribed therapy, and the dialysis machine controller unit may be configured to calculate a treatment rate that would be required to complete the input prescribed therapy within the amount of time calculated by the autonomous vehicle control system. The dialysis machine controller unit may also be configured to determine whether the calculated treatment rate is within acceptable limits, and if the calculated treatment rate is within acceptable limits, the dialysis machine controller unit may be configured to allow the dialysis machine to perform the input prescribed therapy. If the controller unit determines that the calculated treatment rate is not within acceptable limits, the dialysis machine controller unit may also be configured to prevent the dialysis machine from performing the input prescribed therapy.

The present invention also encompasses a vehicle that is not autonomous but comprises a navigation system, a dialysis machine and an interface providing electrical communication between the dialysis machine and the navigation system.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

1 is a front view of the interior of a vehicle showing a dialysis machine partially mounted in the vehicle dashboard according to one or more embodiments of the present invention;

2 is a front view of a vehicle seat back containing a dialysis machine according to various embodiments of the present invention;

3 is a flow chart describing a process for enabling a user to enter a prescribed therapy for dialysis to be completed while traveling to a destination, as well as options that the user may select if the desired therapy is not available;

4 is a flow chart describing a process for enabling a user to enter a prescribed regimen for dialysis to be completed while traveling to a destination, as well as options that the user may select if fuel or electricity is insufficient;

5 is a flow chart describing a process for enabling a user to take actions in response to an alarm signal, wherein the actions include actions that differ depending on the status of the alarm signal;

FIG6 is an exemplary fluid circuit diagram that may be used in vehicles and methods according to the present invention;

FIG7 is another exemplary fluid circuit diagram that may be used in the vehicle and method according to the present invention;

FIG8 is a schematic diagram of an exemplary manifold that may be used in vehicles and methods according to the present invention;

FIG9 is a front view of an embodiment of a controller unit for a dialysis system showing the door open and the manifold installed;

FIG10 is a diagram of an exemplary disconnect monitoring system;

FIG11 is a flow chart defining an exemplary disconnection detection process;

FIG12 is another exemplary fluid circuit diagram that may be used in vehicles and methods according to the present invention;

FIG13 is another exemplary fluid circuit diagram that may be used in vehicles and methods according to the present invention;

FIG14 is another exemplary fluid circuit diagram that may be used in vehicles and methods according to the present invention;

15 is a flow chart describing a process that can be used in the vehicle and method according to the present invention for enabling a user to accurately add additives to a dialysis machine;

16 is a schematic diagram showing a disposable kit including a manifold and a dialyzer attached to a plurality of tubes that can be used in a vehicle and method according to the present invention;

FIG17 is a diagram of yet another exemplary fluid circuit that may be used in vehicles and methods according to the present invention;

FIG. 18 is a further exemplary fluid circuit diagram illustrating a priming mode of operation that may be used in vehicles and methods according to the present invention; and

19 is a schematic diagram illustrating yet another embodiment of an exemplary manifold that may be used in vehicles and methods according to the present invention.

DETAILED DESCRIPTION

The input device for the autonomous vehicle control system may include a display screen in the autonomous vehicle, and the input device for the dialysis machine may include the same display screen or a different display screen. The dialysis machine may also include a transmitter and a receiver, wherein the transmitter is configured to transmit wireless signals related to the dialysis machine and the receiver is configured to receive wireless signals related to the dialysis machine. In this way, the patient can be in constant contact with a monitoring service or clinic during treatment.

The autonomous vehicle may include an engine, and the autonomous vehicle control system may be configured to maintain the engine in operation while the dialysis machine is in operation. The autonomous vehicle includes a battery-powered drive motor, which is configured to move the autonomous vehicle. The autonomous vehicle may also include: a vehicle electrical system; a car battery; an AC generator for charging the car battery during operation of the autonomous vehicle; and a backup battery dedicated to the dialysis machine. The backup battery can then be in electrical communication with the AC generator, and the vehicle electrical system can be configured to charge the backup battery during operation of the autonomous vehicle. The vehicle electrical system may include: an ignition switch; and an ignition switch bypass circuit, which is configured to provide battery power from the backup battery to the dialysis machine when the ignition switch is disconnected during prescribed therapy.

The dialysis machine may include a blood flow circuit comprising a blood pump, a dialyzer, an arterial line, and a venous line. The venous line and the arterial line may be configured to be connected to a patient's blood flow system. The dialysis machine may also include a dialysate flow circuit comprising a dialysate pump, a fresh dialysate line, and a used dialysate line, wherein the fresh dialysate and the used dialysate lines are configured to be connected to the dialyzer. The dialysis machine may also include a dialysis machine alarm system configured to transmit a signal indicating an alarm condition to a receiver. The receiver may include a receiver at a hospital, a receiver at a clinic, a receiver at a medical monitoring service, or a receiver at another emergency center. The dialysis machine alarm system may be configured to determine the nearest hospital, dialysis clinic, urgent care center, or other emergency center and navigate the autonomous vehicle to the nearest hospital, dialysis clinic, urgent care center, or other emergency center to implement corrective measures. If an emergency alarm condition is triggered, navigation to an emergency center may be initiated. The dialysis machine alarm system may include at least one of an arterial transducer and a venous transducer configured to monitor changes in blood flow pressure. In an example, the dialysis machine may include at least one blood pump, the dialysis machine alarm system may include the arterial transducer in the blood flow circuit, and the arterial transducer is configured to stop the at least one blood pump if the arterial transducer registers a pressure change that exceeds a threshold limit. Similarly, the dialysis machine may include at least one blood pump, the dialysis machine alarm system may include the venous transducer in the blood flow circuit, and the venous transducer is configured to stop the at least one blood pump if the venous transducer registers a pressure change that exceeds a threshold limit.

The dialysis machine may include a blood flow circuit comprising: a blood pump; a dialyzer; an arterial line configured to be connectable to a patient's blood flow system; a venous line configured to be connectable to the patient's blood flow system; and an emergency alert system operatively configured to indicate an emergency situation. The emergency alert system may be configured such that, upon activation, the autonomous vehicle control system navigates the autonomous vehicle to a hospital, a dialysis clinic, an urgent care center, or another emergency center to implement corrective measures. For example, the autonomous vehicle control system may be configured such that, upon activation of the emergency alert system, the autonomous vehicle control system determines the nearest emergency center and navigates the autonomous vehicle to the nearest emergency center to implement corrective measures. The autonomous vehicle control system may be configured such that, upon activation of the emergency alert system, the autonomous vehicle control system determines the nearest emergency center, sends a notification to the determined nearest emergency center, and navigates the autonomous vehicle to the nearest emergency center to implement corrective measures, wherein the notification is related to the emergency situation that triggered the activation of the emergency alert system.

The dialysis machine may further include an arterial line pressure sensor, a venous line pressure sensor, and an alarm system, wherein the alarm system is configured to indicate an alarm condition if one or both of the arterial line pressure sensor and the venous line pressure sensor senses a pressure exceeding a respective maximum threshold or falling below a respective minimum threshold. The dialysis machine may include at least one blood pump and an alarm system, wherein the alarm system is configured to: (1) stop operation of the at least one blood pump in response to receiving a low-level alarm signal; and (2) navigate the autonomous vehicle to the nearest emergency center in response to receiving an emergency alarm signal.

The autonomous vehicle may further comprise: an engine; a fuel source for the engine; a fuel sensor configured to sense the amount of fuel available to the engine; and a dialysis controller for the dialysis machine. The dialysis controller may comprise a user interface configured to enable a user to input a prescribed therapy into the dialysis machine. The interface between the dialysis machine and the autonomous vehicle control system may comprise electrical communication between the fuel sensor and the dialysis controller. The fuel sensor may be configured to send a signal to the dialysis controller indicating the amount of fuel available to power the engine, and the dialysis controller may be configured to notify the user if insufficient fuel is available to power the engine within the amount of time required to perform the prescribed therapy. The dialysis controller may be configured to calculate the amount of fuel that would be required to operate the autonomous vehicle within the time period required to perform the prescribed therapy, and then notify the user if insufficient fuel is available to power the engine within the amount of time required to perform the prescribed therapy. The dialysis controller may be configured to calculate an amount of fuel based on the measured current consumption rate and based on a predicted consumption rate that will be required to operate the autonomous vehicle and the dialysis machine together for the amount of time that will be required to perform the prescribed therapy. The dialysis controller may also be configured to prevent the dialysis machine from performing the prescribed therapy if insufficient fuel is available to power the engine for the amount of time that will be required to perform the prescribed therapy.

The autonomous vehicle may further include: a battery-powered power motor; a battery configured to supply battery power to the power motor; a battery sensor configured to sense the amount of battery power available to the power motor; and a dialysis controller for the dialysis machine. The dialysis controller may include a user interface configured to enable a user to input a prescribed therapy into the dialysis machine. The interface between the dialysis machine and the autonomous vehicle control system may include electrical communication between the battery sensor and the dialysis controller, and the battery sensor may be configured to send a signal to the dialysis controller indicating the amount of battery power available to power the power motor. The dialysis controller may be configured to notify the user if insufficient battery power is available to power the power motor within the time required to perform the prescribed therapy. The dialysis controller may be configured to calculate the amount of battery power required to operate the autonomous vehicle within the time period required to perform the prescribed therapy, and then notify the user if insufficient battery power is available to power the power motor within the time required to perform the prescribed therapy. Furthermore, the dialysis controller can be configured to calculate the amount of battery power based on the measured current consumption rate and based on the predicted consumption rate that will be required to operate the autonomous vehicle and the dialysis machine together for the amount of time that will be required to perform the prescribed therapy. The dialysis controller can also be configured to prevent the dialysis machine from performing the prescribed therapy if there is insufficient battery power to power the power motor for the amount of time that will be required to perform the prescribed therapy.

The dialysis machine may include a recirculating dialysate fluid circuit and a sorbent cartridge in fluid communication with the recirculating dialysate fluid circuit. The autonomous vehicle may include an engine and an engine control system. The dialysis machine may include at least one fluid flow path, and the interface may be configured to use heat from an engine cooling system to heat one or more fluids flowing through the at least one fluid flow path. The engine cooling system may include an engine coolant flow path, and the interface may provide heat exchange communication between the transmitter coolant flow path and the at least one fluid flow path of the dialysis machine. The at least one fluid flow path of the dialysis machine may include a dialysate flow path, and the interface may include a heat exchanger in thermal communication with the engine coolant flow path and the dialysate flow path. The dialysis machine may include: a dialysate fluid flow path; and a heater in thermal communication with the dialysate fluid flow path to heat the dialysate fluid in the dialysate fluid flow path. The heater may include a resistive heater, an electric heater, a radiant heater, a Peltier heater, or the like.

According to one or more embodiments of the present invention, an autonomous vehicle is provided, comprising: a vehicle interior; an autonomous vehicle control system; a dialysis machine; and an interface that provides electrical communication between the dialysis machine and the autonomous vehicle control system. The dialysis machine can be configured to perform dialysis treatment on a patient while the autonomous vehicle is under the control of the autonomous vehicle control system. The dialysis machine can include: a control unit; and a container that is fixedly attached to the vehicle interior and configured to accommodate a disposable dialysis device. The autonomous vehicle can also include a vehicle electrical system, and the dialysis machine can be hard-wired to the vehicle electrical system. The dialysis machine can also include a disposable dialysis device, for example, including a molded plastic manifold that defines a first flow path and a second flow path that is fluidically isolated from the first flow path. The molded plastic manifold can be accommodated by the container. The disposable dialysis device can also include a dialyzer, and the molded plastic manifold is coupled to a plurality of tubes, wherein at least two of the plurality of tubes are in fluid communication with the dialyzer. The dialyzer bayonet can be fixedly attached to the interior of the vehicle and configured to fixedly secure the dialyzer relative to the dialysis machine. The disposable dialysis device can also include a sorbent cassette, and the molded plastic manifold can be coupled to a plurality of tubes, wherein at least two of the plurality of tubes are in fluid communication with the sorbent cassette. The cassette bayonet can be fixedly attached to the interior of the vehicle and configured to fixedly secure the sorbent cassette relative to the dialysis machine.

The dialysis machine may further comprise a door having an interior face and a housing built into the interior of the autonomous vehicle and comprising a panel. The housing and the panel may be configured such that the two together define a recessed area configured to accommodate the interior face of the door. The receptacle may be fixedly attached to the panel. The panel may be configured to provide access to a plurality of pumps, and the dialysis machine may further comprise pumps, such as at least one blood pump and at least one dialysate pump. The pumps may be operable to be positioned in substantially parallel alignment with each other, and the panel may further be configured to provide access to the pumps. The interior face of the door may comprise a pump shoe that is aligned with the pump when the door is in a closed position. The door may have an exterior face, and the control unit may be mounted on the exterior face of the door.

The dialysis machine may further include a surface for holding a container of fluid. The surface may be built into a floor or a seat of the autonomous vehicle. A scale may be integrated with the surface and configured to weigh a container of fluid placed on the surface. A heater may be configured to be in thermal communication with the surface, and a conductivity sensor may be configured to be in electromagnetic communication with the surface. In some cases, the autonomous vehicle includes an instrument panel, and the control unit is mounted in or on the instrument panel. The autonomous vehicle may include a graphical user interface, and the graphical user interface may be mounted in or on the instrument panel. The dialysis machine may further include a plurality of connectors and electronic circuit elements. The electronic circuit elements may include a processor module, a data acquisition module in electrical communication with the processor module, and an interface module in electronic communication with the data acquisition module. The electronic circuit elements may include a video module, a touch panel element in electrical communication with the video module, a pulse display, one or more pressure displays, an electrocardiogram display, or a combination thereof. The plurality of connectors may include a blood pressure device input, a pulse device input, an EKG device input, or a combination thereof, and the like. The autonomous vehicle may further include a sump, the vehicle interior may include a floor, the dialysis machine may include a plurality of connectors, the sump may be affixed to the floor, and the sump may be positioned relative to the dialysis machine to catch liquid that drips from one or more of the plurality of connectors if liquid drips from the connectors. The sump may be removably affixed to the floor. The sump may be removably affixed to a seat of the autonomous vehicle.

According to one or more embodiments of the present invention, the vehicle may be, but need not be, an autonomous vehicle. Although referred to below as a non-autonomous vehicle to distinguish it from some of the above-described embodiments, it should be understood that the features described below may also be included in an autonomous vehicle and are thus fully within the scope of the present invention.

Non-autonomous vehicles may include motor vehicles, hybrid vehicles, airplanes, trains, submarines, helicopters, ships, boats, or aircraft, among others. The vehicle may include a vehicle navigation system, a dialysis machine, and an interface that provides electrical communication between the dialysis machine and the vehicle navigation system. The dialysis machine may be configured to perform dialysis treatment on a patient while the vehicle is in operation. The dialysis machine may include: a controller; a door having an interior face; a housing built into the interior of the vehicle and including a panel, wherein the housing and the panel define a recessed area facing the interior face of the door; and a disposable circuit container attached to the panel. The vehicle may also include a vehicle electrical system, wherein the dialysis machine is hardwired to the vehicle electrical system. The vehicle may include at least one battery for powering one or more components of the vehicle, and the interface may provide electrical communication between the at least one battery and the dialysis machine.

The vehicle navigation system may include an input device by which a user can input a desired destination. The vehicle navigation system may be configured to calculate the amount of time required for the vehicle to reach the desired destination. The dialysis machine may include an input device by which a user can input a desired prescribed therapy. The dialysis machine may further include a control unit configured to calculate a treatment rate that would be required to complete the input prescribed therapy within the amount of time calculated by the vehicle navigation system. The dialysis machine control unit may further be configured to determine whether the calculated treatment rate is within acceptable limits, and if the calculated treatment rate is within acceptable limits, the dialysis machine control unit may further be configured to allow the dialysis machine to perform the input prescribed therapy. If the dialysis machine control unit determines that the calculated treatment rate is not within acceptable limits, the dialysis machine control unit may further be configured to prevent the dialysis machine from performing the input prescribed therapy.

The dialysis machine may further include a transmitter and a receiver. The transmitter may be configured to transmit wireless signals related to the dialysis machine, and the receiver may be configured to receive wireless signals related to the dialysis machine. The vehicle may further include: a vehicle electrical system; a car battery; an AC generator for charging the car battery during operation of the vehicle; and a backup battery dedicated to the dialysis machine. The backup battery may be in electrical communication with the AC generator, and the vehicle electrical system may be configured to charge the backup battery during operation of the vehicle. The vehicle electrical system may include: an ignition switch; and an ignition switch bypass circuit configured to provide battery power from the backup battery to the dialysis machine when the ignition switch is disconnected.

Similar to the autonomous vehicles discussed above, the dialysis machine in the non-autonomous vehicle may also include an emergency alert system that is operably configured to indicate an emergency situation. Upon activation of the emergency alert system, the vehicle navigation system may be caused to navigate the vehicle to an emergency center to implement corrective measures. Upon activation of the emergency alert system, the vehicle navigation system may determine the nearest emergency center and navigate the vehicle to the nearest emergency center to implement corrective measures. In some cases, upon activation of the emergency alert system, the vehicle navigation system may determine the nearest emergency center, send a notification to the nearest emergency center so determined, and navigate the vehicle to the nearest emergency center to implement corrective measures. The notification may be related to the emergency situation that triggered the activation of the emergency alert system.

The dialysis machine may further comprise an arterial line pressure sensor, a venous line pressure sensor, and an alarm system, and the alarm system is configured to indicate an alarm condition when one or both of the arterial line pressure sensor and the venous line pressure sensor sense a pressure exceeding a respective maximum threshold or falling below a respective minimum threshold. The dialysis machine may comprise at least one blood pump and such an alarm system. The alarm system may be configured to: (1) stop operation of the at least one blood pump in response to receiving a low-level alarm signal; and (2) navigate the autonomous vehicle to the nearest emergency center in response to receiving an emergency alarm signal. The dialysis machine alarm system may further be configured to send a signal indicating the alarm condition to a receiver. The receiver may comprise a receiver at a hospital, a receiver at a clinic, a receiver at a medical monitoring service, or a receiver at another emergency center. The dialysis machine may comprise at least one of an arterial cavity transducer and a venous cavity transducer in the blood flow path configured to monitor changes in blood flow pressure.

The vehicle may include: an engine; a fuel source for the engine; a fuel sensor configured to sense the amount of fuel available to the engine; and a dialysis control unit for the dialysis machine. The dialysis control unit may include a user interface configured to enable a user to input a prescribed therapy into the dialysis machine, and the interface between the dialysis machine and the autonomous vehicle control system may include electrical communication between the fuel sensor and the dialysis control unit. The fuel sensor may be configured to send a signal to the dialysis control unit indicating the amount of fuel available to power the engine. The dialysis control unit may be configured to notify the user if there is insufficient fuel to power the engine within the amount of time required to perform the prescribed therapy. In some cases, the dialysis control unit may be configured to calculate the amount of fuel that would be required to operate the vehicle within the time period required to perform the prescribed therapy, and then notify the user if there is insufficient fuel to power the engine within the amount of time required to perform the prescribed therapy. The dialysis control unit may be configured to calculate an amount of fuel based on the measured current consumption rate and based on a predicted consumption rate that will be required to operate the vehicle and dialysis machine together for the amount of time that will be required to perform the prescribed therapy. The dialysis control unit may be configured to prevent the dialysis machine from performing the prescribed therapy if insufficient fuel is available to power the engine for the amount of time that will be required to perform the prescribed therapy.

In the case where the vehicle includes a battery-driven power motor, a battery is provided to supply battery power to the power motor. A battery sensor may be configured to sense the amount of battery power available to the power motor, and a dialysis control unit used by the dialysis machine may include a user interface configured to enable a user to input a prescribed therapy into the dialysis machine. The interface between the dialysis machine and the autonomous vehicle control system may include electrical communication between the battery sensor and the dialysis control unit. The battery sensor may be configured to send a signal indicating the amount of battery power available to power the power motor to the dialysis control unit, and the dialysis control unit may be configured to notify the user whether the battery power available to power the power motor is insufficient within the amount of time required to perform the prescribed therapy. The dialysis control unit may be configured to calculate the amount of battery power required to operate the vehicle within the time period required to perform the prescribed therapy, and then notify the user whether the battery power available to power the power motor is insufficient within the amount of time required to perform the prescribed therapy. The dialysis control unit may be configured to calculate the amount of battery power based on the measured current consumption rate and based on the predicted consumption rate that will be required to operate the vehicle and dialysis machine together for the amount of time that will be required to perform the prescribed therapy. The dialysis control unit may also be configured to prevent the dialysis machine from performing the prescribed therapy if there is insufficient battery power to power the power motor for the amount of time that will be required to perform the prescribed therapy.

Similar to the autonomous vehicles discussed above, non-autonomous vehicles may also include a sump. The vehicle interior may include a floor, the dialysis machine may include a plurality of connectors, and the sump may be secured to the floor in a position relative to the dialysis machine such that, in the event of liquid leaking from one or more of the plurality of connectors, the sump can capture the liquid that leaks from the connectors. The sump may be removably secured to the floor, removably secured to a seat in the vehicle, removably secured to a trunk of the vehicle, or the like.

The vehicle may further comprise an instrument panel, and the dialysis machine may comprise a graphical user interface mounted in or on the instrument panel. The dialysis machine may further comprise a front panel associated with electronic circuit elements. The electronic circuit elements may comprise a processor module, a data acquisition module in electrical communication with the processor module, an interface module in electronic communication with the data acquisition module, a video module, a touch panel element in electrical communication with the video module, a pulse display, an EKG display, or a combination thereof. The dialysis machine may further comprise a front panel associated with a plurality of connectors, wherein the plurality of connectors comprise a blood pressure device input, a pulse device input, an EKG device input, or a combination thereof.

Referring to the accompanying drawings, FIG1 is a front view of the interior 100 of a vehicle according to one or more embodiments of the present invention. While the vehicle can be autonomous, it does not have to be. The vehicle includes an instrument panel 102, a dialysis machine 104 mounted in or on the instrument panel 102, and a user interface 106 for programming the dialysis machine 104 and the vehicle's navigation system. The user interface 106 may include a keyboard 108, a display screen 110, a microphone, and quick control buttons 136 for controlling the display screen 110. The display screen 110 may be a common display screen for displaying user prompts, queries, instructions, and similar information. For example, the display screen 110 may be split to function as one or more of the quick control buttons 136. Navigation information 112 and dialysis treatment information 114 may be displayed simultaneously using a split-screen feature. One or more buttons or features may be included to access a voice-activated system for inputting information. This information may include, for example, vehicle navigation information, dialysis treatment instructions, other information, or combinations thereof.

The dialysis machine 104 may include a blood pump 120, a dialysate pump 122, a dialyzer 124, a sorbent cartridge 126, an anticoagulant injection system 128, a pressure sensor 130, and a drip chamber 132. One or more of the dialysis machine components may be disposable. Many of the dialysis machine components may be provided in conjunction with a disposable kit.

The vehicle equipped with the dialysis machine 104 may include a navigation system that can display information on a display screen 110. In FIG1 , navigation information 112 is displayed on the right side of the display screen 110, and the display screen 110 is configured as a split-screen display. The left side of the display screen 110 can display information related to the dialysis treatment to be performed by the dialysis machine 104, user prompts, inquiries, instructions, etc.

A door (not shown) can be used to fit the dialysis machine 104 into and protect the recess 150 provided in the dashboard 102. For example, access to the dialysis machine 104 is achieved using a lock on the door or a spring lock including a handle provided in the glove box 134.

The dialysate circuit of the dialysis machine 104 may include a line 140 to the reservoir and a line 142 from the reservoir that are in fluid communication with a remote reservoir (not shown). The remote reservoir may be, for example, disposed in a glove box 134, in the trunk of a vehicle, in the back seat of a vehicle, in the passenger seat, mounted in other locations on the dashboard, or in another appropriate location of the vehicle. For example, the reservoir may be disposed above a heater and a scale. The dialysis machine 104 may also include a line 144 from the patient's venous catheter and a line 146 to the patient's arterial catheter for connecting the dialysis machine 104 to the patient. The venous catheter line 144 and the arterial catheter line 146 may be included in a disposable kit, for example, included in a kit that also includes the dialyzer 124, the sorbent cartridge 126, the anticoagulant injection system 128, the drip chamber 132, and the interconnected tubing system. Any number of different disposable kits may be configured to work in conjunction with the dialysis machine 104, and many disposable kits are described below. Different kits can be set up to perform different treatments.

Information related to the operation of the vehicle can be displayed in the vehicle operation information display panel 138. This information can include, for example, speed, rpm (rotational speed), oil temperature, oil pressure, and external temperature. According to one or more embodiments of the present invention, the vehicle navigation system and the dialysis machine 104 can be connected so that dialysis treatment can be performed on the patient while the vehicle is transporting the patient to the destination.

FIG2 is a front view of a vehicle seat 200 according to one or more embodiments of the present invention. A dialysis machine 204 is incorporated into the vehicle seat 200. The dialysis machine 204 can be disposed in a recess 250 formed in the vehicle seat 200, or recessed in whole or in part within the recess 250. In the illustrated embodiment, the dialysis machine 204 is recessed into the back of the vehicle seat 200, although other locations may also be used.

Although a vehicle seat can be provided in an autonomous vehicle, the vehicle need not be autonomous. The dialysis machine 204 can be provided with a user interface, and in a typical embodiment, the user interface can include a touch screen, such as the display screen 210, which can also serve as a touch screen input device that can be used to program the dialysis machine 204. The dialysis machine 204 can be connected to the vehicle navigation system so that if the vehicle is expected to arrive at the desired destination before the requested therapy can be completed, the therapy will not be authorized. Although not shown, the user interface can also or instead include a keyboard, microphone, joystick, or a combination thereof, etc.

The display screen 210 can be at least partially controlled using the quick control buttons 236. The display screen 210 can be a common display screen for displaying user prompts, queries, instructions, and similar information. The display screen 210 can be split, for example, to serve the functions of one or more of the quick control buttons 236. Although only the dialysis treatment information 214 is displayed on the display screen 210 in FIG2 , it should be understood that navigation information and dialysis treatment information can be displayed simultaneously using a split-screen function. One or more buttons or features can be included to access a voice-activated system for inputting information. This information can include, for example, transportation navigation instructions, dialysis treatment instructions, other information, or combinations thereof.

The dialysis machine 204 may include a blood pump 220, a dialysate pump 222, a dialyzer 224, a sorbent cartridge 226, an anticoagulant infusion system 228, a pressure sensor 230, and a drip chamber 232. One or more of the dialysis machine components may be disposable. Many of the dialysis machine components may be collectively provided as a disposable kit.

A vehicle equipped with the vehicle seat 200 and the dialysis machine 204 may include a navigation system that can display information on the display screen 210. For example, navigation information can be displayed on the right side of the display screen 210 and treatment information can be displayed on the left side of the display screen 210. This information may include user prompts, inquiries, instructions, warnings, and alarm signals related to the dialysis treatment to be performed or being performed by the dialysis machine 204.

A door (not shown) can be used to enclose and protect the dialysis machine 204 within the recess 250. Access to the dialysis machine 204 is possible, for example, using a lock on the door or a spring lock including a handle. A hinge can be provided spaced from but adjacent to the edge 252 of the vehicle seat 200. A hinge can be provided to allow the door to be hingedly attached to the recess 250 or elsewhere on the vehicle seat 200.

The dialysate circuit of the dialysis machine 204 may include a line 240 to the reservoir and a line 242 from the reservoir in fluid communication with a reservoir 260. The reservoir may be optionally located, for example, in a glove box, beneath the vehicle seat 200, in a trunk of a vehicle, in a back seat of a vehicle, in a passenger seat of a vehicle, in a cargo compartment, or in another suitable location of the vehicle. The reservoir may be operably associated with a heater, a scale, or both. For example, as shown, a heating and weighing system may be provided below the reservoir 260 to heat and weigh the contents of the reservoir 260. A conductivity sensor 272 may also be provided to measure the conductivity of the dialysate in the reservoir.

The dialysis machine 204 may also include a venous catheter line 244 from the patient and an arterial catheter line 246 to the patient that connects the dialysis machine 204 to the patient. During treatment, the patient may sit, for example, in a seat directly behind the vehicle seat 200. The venous catheter line 244 and the arterial catheter line 246 may be included in a disposable kit, for example, a kit that also includes the dialyzer 224, the sorbent cartridge 226, the anticoagulant injection system 228, the drip chamber 232, and the interconnecting tubing system. Any number of different disposable kits may be configured to work in conjunction with the dialysis machine 204, and a number of disposable kits are described below. Different kits may be provided to perform different treatments.

FIG3 is a flow chart describing a process for enabling a user to input a prescribed therapy for dialysis to be completed while the user is traveling to a destination. Initially, the user can input the prescribed therapy to be performed and the destination. Although the treatment or destination can be entered first, FIG3 shows the input of the prescribed therapy as a first step 300, followed by a step 302 for inputting the destination. The treatment and/or destination can be input using voice activation, a keyboard, a touch screen, a joystick, or a combination thereof. The vehicle navigation system can be equipped with a processor and a global positioning system (GPS), wherein the processor and GPS can be used together to calculate the arrival time as shown in step 304. During travel, the calculated arrival time can be adjusted and one or more revised arrival times can be displayed.

As shown in step 306, the processor can determine whether the requested therapy can be completed before the arrival time based on the input prescribed therapy and the calculated arrival time. If the treatment can be completed, the dialysis machine display can be used to display a message such as "Press START to continue therapy" as shown in step 308. If the processor determines in step 306 that the requested therapy cannot be completed before the arrival time, the display can be powered on to display a message such as "Insufficient time before arrival to complete therapy" as shown in step 310. If the processor or an associated data storage, memory, or other data source indicates that an alternative therapy is available that can be completed before the calculated arrival time, the processor can power on the display to display a message such as "Show therapies that can be completed before the arrival time?" as shown in step 312. If there are available alternative therapies, the system can be configured to display different options and can prompt the user to select one of the alternative therapies or cancel the programming. If the user does not want to see a list of available alternative therapies, the user may enter "No" in response to the query at step 314, and in response, as shown at step 316, the system may be configured to display a message such as "Press GO to proceed to your destination."

If alternative therapies are available and the user wishes to see them, the user may enter a "yes" command in response to the query at step 314, and the processor may calculate and display the alternative therapies that can be completed before the time is reached. The calculated therapy is shown at step 318, and the displayed therapy is shown at step 320. Once the alternative therapies are displayed, the user may be prompted to select one of the alternative therapies, and the selection may be entered at step 322. Once an alternative therapy is selected, the display may be powered on to display a message such as "Press START to continue therapy," as shown at step 324.

FIG4 is a flow chart describing a process for enabling a user to input a prescribed therapy for dialysis to be completed while traveling to a destination. In the process shown in FIG4 , a vehicle information system is connected to a dialysis machine, and a processor is used to determine whether there is enough fuel, battery power, other energy sources, or a combination thereof to enable the vehicle to operate within the time required to complete the requested dialysis therapy. Although many energy sources can be used, these energy sources are illustrated as fuel (or electricity) in FIG4 . As shown in FIG4 , as shown in step 400, a prescription for dialysis therapy can be input into the processor. The processor can then determine whether the vehicle has enough fuel, battery power, other energy sources, or the like to operate for the required time based on the amount of available fuel, battery power, other energy sources, or a combination thereof. This calculation is shown in step 402. Once the fuel and/or battery power are compared with the amount required to complete the requested prescribed therapy, the processor can answer the inquiry shown in step 404, i.e., whether the vehicle has enough fuel and/or battery power. If sufficient fuel and/or battery power is present, the processor may send a signal to display a message such as "Press START to continue therapy," as shown in step 406 .

If the processor determines in step 404 that the requested therapy cannot be performed based on the available fuel or electricity, then, as shown in step 408, the display may be powered on to display a message such as "Insufficient fuel (or electricity) to complete therapy." If the processor or associated data storage, memory, or other data source indicates that an alternative therapy is available that can be performed using the available fuel or electricity, then, as shown in step 410, the processor may power on the display to display a message such as "Showing therapies that can be performed using the available fuel (or electricity)." If there are available alternative therapies, the system may be configured to display different options and may prompt the user to select one of the alternative therapies or cancel the programming. If the user does not want to see a list of available alternative therapies, the user may enter "no" in response to the query in step 412, and in response, as shown in step 414, the system may be configured to display a message such as "Cancel therapy."

If optional therapies are available and the user wishes to view them, the user enters a "yes" command in response to the query at step 412, and the processor calculates and displays the optional therapies that can be performed based on the available fuel or electricity. Calculating the therapy is shown at step 416, and displaying the therapy is shown at step 418. Once the optional therapies are displayed, the user may be prompted to select one of the optional therapies and may enter the selection at step 420. Once the optional therapy is selected, the display may be powered on to display a message such as "Press START to continue therapy," as shown at step 422.

FIG5 is a flow chart describing a process for enabling one or more dialysis machines and/or vehicle operations to be performed in response to an alarm signal. As described in more detail below, the dialysis machine contained within the vehicle may be provided with an alarm system, wherein the alarm system may be configured to generate one or more alarm signals, each indicating one or more alarm conditions. Similar to conventional dialysis machines, the dialysis machine may be provided with sensors for detecting leaks, occlusions, bubbles, pressure loss, disconnection, pressurization, blood pulse, electrocardiogram, or other conditions and parameters. In many cases, a low-level alarm signal may be generated for conditions that can be easily corrected by the user. However, in some cases, more serious conditions may trigger an emergency alarm signal, such as one indicating a serious situation requiring immediate attention and which the user may not be able to correct. Exemplary conditions that may trigger an emergency alarm signal would be a lack of pulse, a lack of heartbeat, a lack of arterial pressure, or a vehicle collision. As shown in FIG5 , the alarm system may be programmed to receive an alarm signal in step 500 and determine whether the alarm signal is an emergency signal, as shown in step 502. If the alert signal is an emergency alert signal, the alert system can be configured to calculate the nearest emergency center as shown in Figure 504 and navigate the vehicle to the nearest emergency center as shown in step 506. As shown in step 508, the alert system can display a message such as "Go to the nearest emergency center". As shown in step 510, the alert system can also be configured to provide additional information, such as by displaying the name, address, and telephone number of the nearest emergency center to which the vehicle is being navigated. The alert system can also be configured to automatically call a helpline or 911.

If the alarm system determines in step 502 that the alarm signal does not indicate an emergency, the alarm system may be configured to stop the blood pump, as shown in step 512, and display a message such as "Check connection, check occlusion, check for bubbles," as shown in step 514. This prompts the user to take corrective action, such as to reestablish a connection, eliminate bubbles, or adjust the position of the catheter in the vein or artery, as shown in step 516. After taking the corrective action, the user may then enter a "Continue" command, and the alarm system may then test the condition that caused the low-level alarm signal. Testing for this condition is shown in step 518. If the condition is corrected, as inquired in step 520, the alarm system may be reset, as shown in step 522. However, if the condition is not corrected in response to the user's corrective action, the system may be configured to again display a message such as "Check connection, check occlusion, check for bubbles," as shown in step 514, and the corrective action sequence may be repeated. If the user's corrective action fails to correct the alarm condition after a predetermined number of attempts, the user may be prompted to go to the nearest emergency center.

Figures 6 to 19 illustrate various disposable kits, machines, machine and system components, fluid flow paths, and related features that can be included in the vehicle of the present invention and used in the method of the present invention. Other components, machines, systems, and methods that can be used in the present invention or a portion thereof include those described in U.S. Patent Application Publication US 2011/0315611 A1 by Fulkerson et al. and U.S. Patent Application Publication US 2010/0022937 A1 by Bedingfield et al., the entire contents of which are incorporated herein by reference. In addition, other dialysis components, machines, systems, and methods that can be used in the present invention or a portion thereof can include those described in U.S. Patent No. 4,353,368 by Slovak et al., the entire contents of which are incorporated herein by reference. In addition, dialysis components, machines, systems, and methods related to peritoneal dialysis and that may be used in the present invention or a portion thereof include those described in U.S. Patent No. 6,129,699 to Haight et al., U.S. Patent No. 6,234,992 Bl to Haight et al., and U.S. Patent No. 6,284,139 Bl to Piccirillo et al., the entire contents of which are incorporated herein by reference. In addition, components, machines, systems and methods for autonomous control of vehicles that may be used in the present invention or a portion thereof include those described in U.S. patent application publication US2001/0055063 A1 of Nagai et al., U.S. patent application publication US 2012/0316725 A1 of Trepagnier et al., U.S. patent application publication US 2012/0101680 A1 of Trepagnier et al., U.S. patent application publication US2012/0035788 A1 of Trepagnier et al., U.S. patent application publication US 2010/0106356 A1 of Trepagnier et al., U.S. patent application publication US 2007/0219720 A1 of Trepagnier et al. and U.S. patent application publication US 2012/0179321 A1 of Biber et al., the entire contents of these seven applications are incorporated herein by reference.

Figure 6 shows a functional block diagram of an embodiment of an ultrafiltration treatment system 2800 that can be used in a vehicle of the present invention. As shown in Figure 6, blood is drawn from a patient into a blood inlet tubing system 2801 using a pump, such as a peristaltic blood pump 2802. Peristaltic blood pump 2802 forces the blood into a hemofilter cartridge 2804 via a blood inlet port 2803. An inlet pressure transducer 2805 and an outlet pressure transducer 2806 are connected in series immediately before and after blood pump 2802. Hemofilter 2804 includes a semipermeable membrane that allows for ultrafiltration of excess fluid from the passing blood by convection. The ultrafiltered blood is further pumped from hemofilter 2804 via a blood outlet port 2807 into a blood outlet tubing system 2808 for infusion back to the patient. Regulators, such as clamps 2809 and 2810, are used in tubing systems 2801 and 2808 to regulate the flow of fluid.

A pressure transducer 2811 is connected near the blood outlet port 2807, followed by a bubble detector 2812 located downstream of the pressure transducer 2811. An ultrafiltration pump, such as a peristaltic pump 2813, draws waste ultrafiltrate from the hemofilter 2804 via the UF (ultrafiltration) outlet port 2814 and into the UF outlet tubing 2815. A pressure transducer 2816 and a blood leak detector 2817 are replaced with the UF outlet tubing 2815. The waste ultrafiltrate is ultimately drawn into a waste collection reservoir 2818, such as a bottle or soft bag, attached to the leg of the bedridden patient and equipped with a drain port to enable intermittent emptying. The amount of waste ultrafiltrate can be monitored using any measurement technology, including a scale 2819 or a flow meter. A microcontroller 2820 monitors and manages the functions of the blood and UF pumps, the pressure sensor, and the air and blood leak detectors. Standard Luer connections, such as Luer twist lock and Luer slip lock, are used to connect the tubing system to the pump, hemofilter, and patient.

FIG7 illustrates another blood and dialysate circuit that can be implemented or used in an embodiment of a dialysis system. FIG7 illustrates a fluid circuit of an extracorporeal blood treatment system 2900 for performing 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 comprises two circuits, a blood circuit 2901 and a dialysate circuit 2902. Blood treatment during dialysis involves extracorporeal circulation via an exchanger (hemodialyzer or dialyzer 2903) with a semipermeable membrane. The patient's blood circulates in the blood circuit 2901 on one side of the membrane (dialyzer) 2903, and the dialysate comprising the main electrolyte in the blood at a concentration prescribed by the doctor circulates on the other side of the dialysate circuit 2902. The circulation of the dialysate fluid thus provides regulation and adjustment for the electrolyte concentration in the blood.

The line 2904 from the patient that delivers impure blood to the dialyzer 2903 in the blood circuit 2901 is provided with an occlusion detector 2905, wherein the occlusion detector 2905 is usually linked to a visual or audible alarm to signal any obstruction to the blood flow. In order to prevent blood clotting, a delivery component 2906 such as a pump, syringe or any other injection device is also provided for injecting an anticoagulant such as heparin into the blood. A peristaltic pump 2907 is also provided to ensure that the blood flows in the normal (desired) direction.

A pressure sensor 2908 is provided at the inlet of impure blood into the dialyzer 2903. Other pressure sensors 2909, 2910, 2911 and 2912 are provided at various locations in the hemodialysis system to track the fluid pressures at specific points within each circuit and to maintain these fluid pressures at desired levels.

At the point where spent dialysate fluid from the dialyzer 2903 enters the dialysate circuit 2902, a blood leak sensor 2913 is provided to sense and warn of any leakage of blood cells into the dialysate circuit. A pair of bypass valves 2914 are also provided at the beginning and end of the dialysate circuit so that, under startup conditions or other conditions deemed necessary by the machine status or operator, the dialysate fluid can be caused to flow around the dialyzer while still maintaining dialysate fluid flow, i.e., for flushing or priming operations. Another valve 2915 is provided immediately before the startup/drain port 2916. Port 2916 is used to initially fill the circuit with dialysate solution and subsequently (in some instances, during dialysis) remove spent dialysate fluid. During dialysis, valve 2915 can be used to replace a portion of the spent dialysate with a supplemental solution of appropriate concentration, such as a high concentration of sodium, thereby maintaining the total component concentration of the dialysate at a desired level.

The dialysate circuit is provided with two peristaltic pumps 2917 and 2918. Pump 2917 is used to draw dialysate fluid to a drain or waste container and to draw regenerated dialysate to the dialyzer 2903. Pump 2918 is used to draw spent dialysate from the dialyzer 2903, maintaining fluid pressure via the sorbent 2919, and to draw dialysis fluid from port 2916 to fill the system or maintain the concentration of a component of the dialysate.

A sorbent cartridge 2919 is provided in the dialysate circuit 2902. The sorbent cartridge 2919 comprises several layers of material, each of which functions to remove impurities such as urea and creatinine. The combination of these layered materials enables potable water to be filled into the system for use as the dialysate fluid. This combination also allows for closed-loop dialysis. That is, the sorbent cartridge 2919 enables fresh dialysate to be regenerated from spent dialysate from the dialyzer 2903. For the fresh dialysate fluid, a liner container or reservoir 2920 of an appropriate capacity, such as 0.5, 1, 5, 8, or 10 liters, is provided.

Depending on the patient's needs and based on the physician's prescription, a desired amount of infusion solution 2921 may be added to the dialysis fluid. The infusion solution 2921 is a solution containing minerals and/or glucose that helps replenish minerals such as potassium and calcium in the dialysis solution at levels that are not otherwise removed by the sorbent. A peristaltic pump 2922 is provided to pump the desired amount of infusion solution 2921 into a container 2920. Alternatively, the infusion solution 2921 may be pumped from the reservoir 2920 into an outflow line. A camera 2933 may optionally be provided to monitor changing fluid levels of the infusion solution as a safety check warning of infusion flow failure, and/or as a barcode sensor to scan barcodes associated with additives used during the dialysis process.

A heater 2924 is provided to maintain the temperature of the dialysate fluid in container 2920 at a desired level. The temperature of the dialysate fluid can be sensed using a temperature sensor 2925 located immediately before the fluid inlet to the dialyzer 2903. Container 2920 is also equipped with a scale 2926 for tracking the weight and volume of the fluid in container 2920 and a conductivity sensor 2927 for determining and monitoring the conductivity of the dialysate fluid. The conductivity sensor 2927 provides an indication of the sodium level in the dialysate.

Before the blood from the patient enters the system used for dialysis, a medical port 2929 is provided. Before the clean blood from the dialyzer 2903 is returned to the patient, another medical port 2930 is provided. An air (or bubble) sensor 2931 and a spring clamp 2932 are used in the circuit to detect and prevent any air, gas, or bubbles from returning to the patient.

The priming sets 2933 are attached to the dialysis system 2900, where they help prepare the system by filling the blood circuit 2901 with sterile saline before the dialysis system 2900 is used to perform dialysis. The priming set can include a short section of tubing with a pre-attached IV bag spike or IV needle, or a combination of both.

It should be understood that while certain of the above-described embodiments disclose the inclusion and use of ports for receiving an infusion or administration of an anticoagulant, thereby creating an air-blood interface, such ports may be eliminated if the device can be operated with minimal risk of blood clotting at the inlet and outlet ports. As discussed further below, the manifold design, particularly with respect to the internal design of the manifold ports, minimizes the risk of blood clotting, thereby creating the option of eliminating an air-blood interface for receiving an infusion or administration of an anticoagulant.

Those skilled in the art will infer from the foregoing discussion that the exemplary fluid circuits of hemodialysis and/or hemofiltration systems are complex. If implemented in a conventional manner, the system would appear as a network of tubing and would be too complex to configure and use for a home dialysis user. Therefore, to make the system simple and easy for the user to use at home, embodiments of the present invention implement the fluid circuit in the form of a compact manifold, wherein most of the components of the fluid circuit are integrated into a single piece of molded plastic or configured as multiple pieces of molded plastic that are connected together to form a single operating manifold structure.

FIG8 is a diagram detailing the fluid circuit of a compact manifold according to one embodiment of the present invention. The fluid circuit includes four pump tubing segments 3301, 3302, 3303, and 3304, which are in pressure communication with the pump within the top controller unit and the pump mount in the top controller unit door. The fluid circuit also includes five pressure membranes in pressure communication with pressure sensors 3305, 3306, 3307, 3308, and 3309, as well as an area in thermal or optical communication with a temperature sensor 3310. In the embodiment shown in FIG8 , three pairs of membranes, shown as 3311, 3312, and 3313, are integrated into the manifold. These membranes act as valves when blocked by pins, members, or protrusions from the controller unit.

The six one-way valve pairs thus formed form three two-way valve assemblies 3311, 3312, and 3313. Two-way valves provide greater flexibility in the configuration of control circuits. When conventional two-way valves are used to block a portion of a fluid pathway, these valves are typically configured to enable two distinct fluid pathways, one for a first valve state and the other for a second valve state. As disclosed below, specific valve embodiments, incorporating valve diaphragms or pressure points integrated into a manifold, enable more refined control, thereby enabling the creation of four distinct fluid flow paths.

Pump tube segments 3301, 3302, 3303, and 3304 are combined into a compact manifold. Multiple ports are provided in the manifold, wherein these ports are connected to tubes outside the manifold to allow various fluids to flow in and out of the manifold. These ports are connected to various tubes in the blood purification system to transport fluids as follows:

Port A 3315 - blood to dialyzer 430;

Port B 3316 - dialyzer output (spent dialysate);

Port C 3317 - blood from the patient;

Port D 3318 - for heparin mixed into blood;

Port E 3319 - Reservoir output (fresh dialysate);

Port F 3320 - dialyzer input (fresh dialysate);

Port G 3321 - dialyzer output (blood);

Port H 3322 - Patient return (clean blood);

Port J 3323 - connected to the irrigation and drain lines;

Port K 3324 - Reservoir infusion input;

Port M 3325 - infusion fluid entry from infusion fluid reservoir; and

Port N 3326 - Dialysate flow to sorbent.

In one embodiment, a tubing segment formed as a passageway molded into the manifold structure 3300 connects the fluid flow of heparin entering via port D 3318 to the fluid flow of blood entering via port C 3317. The combined heparin and blood flow through port 3317a via pump segment 3301 and into port 3317b of the manifold 3300. A pressure transducer is in physical communication with a membrane 3305 formed in the manifold structure 3300, which in turn flows blood and heparin through port A 3315. Fluid exiting the manifold 3300 at port A 3315 passes through a dialyzer 3330 located outside the manifold 3300. Dialyzed blood passes back into the manifold 3300 via port G 3321 and into segment 3307 formed as a passageway molded into the manifold structure, which is in physical communication with the pressure transducer. Fluid is then passed from this segment through port H 3322 and into the patient return line.

Separately, dialysis fluid enters the manifold 3300 from the reservoir via port E 3319. The fluid in the reservoir contains an infusion, which first enters the manifold 3300 via port M 3325, passes through a segment formed as a passageway molded into the manifold structure 3300, passes through another port 3325a, passes through segment 3302 connected to the pump, and returns to the manifold 3300 via port 425b. The infusion passes through a segment formed as a passageway molded into the manifold structure 3300 and exits the manifold 3300 at port K 3324, where it enters the reservoir. The dialysis fluid that enters the manifold via port E 3319 passes through a segment formed as a passageway molded into the manifold structure 3300, passes through another port 3319a, passes through segment 3303 connected to the pump, and returns to the manifold 3300 via port 3319b.

The dialysate fluid enters a segment formed as a passageway molded into the manifold structure 3300 that is in physical communication with a pair of valves 3311. The segment formed as a passageway molded into the manifold structure 3300 passes the dialysate fluid to another pair of valves 3313. This segment is in physical communication with a pressure transducer 3308 and an optional temperature sensor 3310. The dialysate fluid exits the manifold 3300 via port F 3320 and enters tubing leading to the dialyzer 3330.

The tubing from the dialyzer 3330 returns fluid into the manifold 3300 via port B 3316 and into a segment formed as a passageway molded into the manifold structure 3300 that is in physical communication with the first pair of valves 3311, the second pair of valves 3312, and the pressure transducer 3306. Spent dialysate fluid exits the manifold 3330 via port 3326b, flows through segment 3304 that is in communication with the pump, and returns to the manifold via port 3326a. The segment in fluid communication with port 3326a is in physical communication with the pressure transducer 3309 and flows through port N 3326 and into the sorbent regeneration system.

The ports are designed for loop tubing (e.g., 0.268" by 0.175" tubing) or for anticoagulant and infusion tubing (e.g., 0.161" by 0.135"). Preferably, the tubing ports are coupled with appropriate solvents. It should be understood that the valves shown in Figure 8, specifically valves 3311, 3312, and 3313, can be configured at different locations within the manifold. Referring to Figure 19, manifold 8611 (valve 3311 in Figure 8) can be located in the central vertical portion 8650 of manifold 8600 adjacent to and parallel to valve 8612 (valve 3312 in Figure 8). Additionally, on the central vertical portion 8650 of manifold 8600 connecting the top horizontal portion 8630 and the bottom horizontal portion 8640 together is valve 8613 (valve 3313 in Figure 8). Valve 8613 is on the bottom of the central vertical portion 8650 and is located approximately below and between valves 8611 and 8612.

As described in further detail below, the 2-way valve operates by causing a valve actuator mounted on the instrument to compress a flexible diaphragm through a volcano seal to prevent dialysate from flowing through its various passageways. The volcano seal opening has a diameter of approximately 0.190" to match the channel geometry. When the valve is open, the cross-sectional passage through the interior of the valve is at least equivalent to a 0.190" diameter. When the valve is in the closed position, the valve actuator and flexible diaphragm occupy the majority of the flow path around the volcano seal, minimizing the possibility of air entrapment. Raised plastic features on the mid-body minimize dead space within the flow path and help prevent the diaphragm from collapsing near the central flow path under negative pressure conditions. The flexible diaphragm has an O-ring feature near the periphery that fits into a groove on the surface of the mid-body. The O-ring is compressed between the mid-body and the back cover to form a fluid-tight seal. This design provides approximately 30% compression of the O-ring. The two-way valve controls the direction of dialysate flow through the manifold.

The manifold contains structure that enables fluid pressure monitoring across the diaphragm using sensors in the instrument. Fluid is allowed to flow from a channel on the front cover side of the midbody through inlet and outlet holes to underneath the diaphragm on the back cover side. The cross-sectional passage through the interior of the pressure sensing structure is at least equivalent to 0.190". The internal passage is designed to minimize air entrapment while providing adequate fluid contact with the diaphragm. The elastic diaphragm has an O-ring feature near its periphery that is embedded in a groove on the surface of the midbody. The O-ring is compressed between the midbody and the back cover to form a fluid-tight seal. This design provides approximately 30% compression of the O-ring.

The valve and diaphragm can be made from a variety of materials and processes. The elastic component can be made from silicone, various thermoplastic elastomers, or combinations thereof. A two-shot molding process can be used to attach the valve and diaphragm to the back cover. Two-shot molding of the valve and diaphragm eliminates the need to assemble these parts into the manifold separately, thereby reducing labor costs and improving the quality of the manifold assembly.

The suction components in the manifold design have been defined as PVC head tubes. These heads, combined with the instrument's rotary peristaltic suction system, provide the flow of blood, dialysate, and infusion fluids. The loop tubing material for dialysate, infusion fluids, and anticoagulants is preferably kink-resistant, such as tubing known as Colorite, Natvar extruded Unichem PTN 780 (80A durometer), both from TEKNIplex. The tubing sizes for the dialysate line range from 0.268" x 0.189" to 0.268" x 0.175.

A thermal flow meter can be used to measure the flow within the manifold. FIG9 shows a thermal fluid flow measurement device 5601 mounted with a manifold 5602 in a dialysis machine 5610. A fluid flow path or tubing loop 5603 is embedded within the manifold 5602. The dialysis machine 5610 has a front door 5620 that can be opened to install a disposable manifold 5620. Furthermore, the front door 5620 is equipped with a pin 5621 that, when the door 5620 is closed, can contact an electrical point on the manifold 5602 to read information or provide electrical input.

The thermal fluid flow measurement device 5601 may also include a series of contacts 5611, 5612, and 5613. In operation, as fluid (such as blood, dialysate, or other fluid) flows through the fluid flow path 5603 during dialysis, the fluid passes through the first contact 5611 embedded in the plastic passageway. Contact 5611 is electrically contacted by an electrical source, which may be a pin 5621 on the front door 5620 of the machine. The electrical source or pin is controlled by a controller in the dialysis machine 5610. The electrical source provides electrical stimulation to the contact 5611, wherein the electrical stimulation is also used to micro-heat the node based on a sine wave method.

The microheating process achieves a temperature increase of 0.1 to 1.0 degrees Celsius in the fluid being measured. This is achieved using a microheater located at first junction 5611 that generates heat when receiving an electrical stimulus. The microheater of the thermal fluid flow measurement device of the present invention can be manufactured using any design suitable for the application. For example, in one embodiment, the microheater is constructed from 10 turns of 30g copper wire wrapped around a pin located at first junction location 5611.

As junction 5611 is slightly heated, the resulting thermal energy acts to generate a thermal wave, which propagates downstream from first junction 5611. Multiple junctions (which may be two, 5612 and 5613) are located downstream of first junction 5611 and are used to measure the time of flight of the thermal wave. The phase of this measured wave is then compared with the initial wave generated by first junction 5611. The phase difference thus determined provides an indication of the flow rate.

FIG10 is a block diagram of a system 5800 for detecting a patient's disconnection from an extracorporeal blood circuit. System 5800 includes an inflowing arterial blood circuit 5802, a dialyzer 5804, a dialysate circuit 5806, a patient pulse pressure transducer 5808, a reference patient cardiac signal generator 5815, a disconnection monitor 5820, a controller 5825, and a return venous blood circuit 5810. In various embodiments of the present invention, blood drawn from the patient passes through the dialyzer 5804 via the arterial blood circuit 5802, and purified blood from the dialyzer 5804 is returned to the patient via the venous blood circuit 5810. Contaminated dialysate discharged from the dialyzer 104 is purified or regenerated within the dialysate circuit 5806 and pumped back to the dialyzer 5804. The purified blood can be returned to the patient's body via a transdermal needle or Luer-connected catheter. The blood flow rate in the return venous blood circuit 5810 is typically in the range of 300-400 ml/min. It will be appreciated that any suitable dialysis circuit may be configured.

Pressure transducer 5808 measures the pulse pressure of a patient undergoing a blood processing routine and communicates this pulse pressure substantially continuously to disconnect monitor 5820. In one embodiment, transducer 5808 is an invasive or non-invasive venous pressure sensor located anywhere in the dialysis blood line (inflowing arterial blood circuit 5802 or return venous blood circuit 5810). In another embodiment, transducer 5808 is an invasive or non-invasive venous pressure sensor located specifically in the dialysis blood line between dialyzer 5804 and the patient (i.e., in return venous blood circuit 5810). A non-invasive bubble detector and/or pinch valve (not shown) may optionally be located between transducer 5808 and the Luer connection to the patient. Pressure transducer 5808 may be located near a needle or catheter inserted into the patient to provide vascular access corresponding to return venous blood circuit 5810. Positioning pressure transducer 5808 near the needle or catheter maintains waveform fidelity. In other embodiments, pressure transducer 5808 can be connected to any location in return venous blood circuit 5810. In embodiments of the present invention, the pressure signal generated by pressure transducer 5808 is an alternating current (AC) signal that is not an accurate measurement of vascular pressure. Thus, pressure transducer 5808 is not a high-precision transducer.

The reference signal generator 5815 communicates the patient's cardiac signal substantially continuously to the disconnect monitor 5820 for reference. The reference cardiac signal can be obtained from a plethysmograph connected to the same body part (such as an arm, etc.) to which the needle or blood vessel that supplies processed blood to the patient is connected. In some cases, the reference cardiac signal is obtained from a finger pulse sensor/oximeter. In various other embodiments of the present invention, the reference cardiac signal can be obtained from an electrocardiogram (ECG) signal, a real-time blood pressure signal, a stethoscope, an arterial pressure signal from a blood collection tube line, an oximeter pulse signal, an alternating station plethysmographic signal, a transmission and/or reflection plethysmographic signal, an acoustic cardiac signal, a wrist pulse, or any other cardiac signal source known to those of ordinary skill in the art.

The disconnection monitor 5820 detects an interruption in the return venous blood circuit 5810 caused by the disconnection of a needle or catheter from the body of a patient undergoing blood processing. To detect the disconnection, the monitor 5820 processes the patient's pulse pressure transducer and cardiac reference signals. It will be understood by those skilled in the art that such a disconnection may be caused by the needle or catheter being pulled out of the patient's body for any reason, such as sudden movement of the patient. The disconnection monitor 5808 may be of a type known to those skilled in the art. The controller 5825 may be any microprocessor known to those skilled in the art. The function of the controller 5825 is to receive processed input from the monitor 5820 and thereby trigger appropriate actions when necessary.

It will be understood by those skilled in the art that the pressure transducer and the reference signal are communicated to the disconnect monitor 5820 via a transmitter that incorporates the reference signal generator and the pressure transducer. The transmitter can enable wired or wireless communication with a corresponding receiver. Similarly, data from the disconnect monitor 5820 is communicated to the controller 5825 via a wired or wireless connection. In one embodiment, such signal communication can be performed using a suitable wired or wireless public and/or private network such as a LAN, WAN, MAN, Bluetooth network, and/or the Internet. In addition, the disconnect monitor 5820 and the controller 5825 can be located near each other and near the pressure transducer 5808 and the reference signal generator 5815. In alternative embodiments, both or either of the disconnect monitor 5820 and the controller 5825 are located remotely from each other and/or remotely from the remaining components of the system 5800.

FIG11 is a flow chart illustrating exemplary steps of a method for determining patient disconnection from an extracorporeal blood circuit according to an embodiment of the present invention. In operation, dialysis system software, including multiple instructions and executing on a processor, prompts a patient to first attach a cardiac signal generator (such as a finger pulse oximeter) to obtain (6005) a reference signal. At this point, the patient may or may not be connected to the dialysis system. After or concurrently with capturing the cardiac reference signal, the dialysis system software, including multiple instructions and executing on a processor, prompts the patient to connect to the system 5800 of FIG10 , which also obtains (6010) the patient's pulse pressure transducer signal. Next, a cross-correlation processor attempts to cross-correlate (6015) the reference signal and the transducer signal. If correlation cannot be achieved at startup, in one embodiment, the patient is prompted to disconnect (6020) all or some components, or in another embodiment, the controller 5825 of the system 5800 of FIG10 automatically performs this operation to reduce noise levels. For example, turning off the dialysis system pump can reduce noise and make it easier to capture and correlate the two signals. In another embodiment, a cross-correlation is attempted before turning on noise-generating system components, such as pumps, etc. Thus, correlation lock is attempted before the entire system startup is complete. If the correlation is not locked, an alarm can be triggered, indicating that there may be an anomaly with the patient's dialysis system.

However, if a correlation is obtained, the correlation is then monitored (6025) substantially continuously. If there is any deviation in the correlation, an alarm is triggered (6030), indicating a possible leak, or alternatively, the system is shut down (completely or partially) and the correlation signal is re-attempted to re-establish the correlation. If the nature of the correlation changes or deviates beyond or within a predefined threshold, certain system components, such as a pump, may be shut down and the correlation processor attempts to re-establish the correlation. If the correlation cannot be re-established, an alarm is triggered. In some cases, if the nature of the correlation changes or deviates beyond or outside a predefined threshold range, certain system components, such as a pump, may be shut down and an alarm immediately triggered, prior to any additional attempts to re-establish the correlation.

This method for monitoring disconnection provides certain significant improvements over the prior art. First, the system can respond if the needle is barely removed or if the needle is removed and withdrawn at a considerable distance from the insertion site. Second, the system does not require any additional equipment such as a moisture-proof pad to be placed at the insertion site. Third, by cross-correlating the patient's own cardiac signals, false negatives are greatly reduced. Fourth, the combination of pressure pulse sensing and cross-correlation enables the system to detect low signal-to-noise ratio signals. Fifth, continuous monitoring of the cross-correlation state enables the system to detect small signal deviations that could potentially indicate a disconnection. Thus, the present invention provides an apparatus and method for disconnection detection in an extracorporeal blood circuit for use in any blood processing routine.

Central venous pressure (CVP) can be measured using a remote sensor within the hemofiltration machine. Referring to FIG12 , an exemplary blood circuit 6400 providing CVP measurement is shown. As blood enters the circuit 6400 from the patient, an anticoagulant is injected into the blood using a syringe 6401 to prevent clotting. A pressure sensor PBIP 6410 is provided, which is used to measure central venous pressure. A blood pump 6420 forces blood from the patient into the dialyzer 6430. Two other pressure sensors, PBI 6411 and PBO 6412, are located at the inlet and outlet of the dialyzer 6430, respectively. Pressure sensors PBI 6411 and PBO 6412 help track and maintain fluid pressure at advantageous points in the hemodialysis system. A pair of bypass valves B 6413 and A 6414 are also provided with the dialyzer to ensure that fluid flow in the desired direction within the closed-loop dialysis circuit. If bubbles are detected by sensor 6418, the user can remove them at port 6417. A blood temperature sensor 6416 is provided before the air elimination port 6417. An AIL/PAD sensor 6418 and a pinch valve 6419 are employed in the circuit to ensure a smooth and unobstructed flow of clean blood to the patient. A priming set 6421 is pre-attached to the hemodialysis system, which helps prepare the system before use for dialysis.

To perform a CVP measurement, blood flow in the circuit 6400 is stopped by stopping the blood pump 6420. At this point, the pressure in the catheter (not shown) used to evaluate the blood will equalize, and the pressure measured at the pressure sensor PBIP 6410 in the hemofiltration machine will equal the pressure at the tip of the catheter. This measured pressure (CVP) is then used to adjust the ultrafiltration rate and volume of fluid removed from the patient.

Thus, in operation, the system modifies a conventional dialysis system so that ultrafiltration is performed at a rate preset by the physician. Blood flow is periodically stopped and the average CVP is measured using one of the various measurement methods described above. In one embodiment, a safety mode is provided in which if the CVP falls below a preset limit, blood filtration is interrupted and an alarm is sounded.

In another application, ultrafiltration can be provided to patients with excessive blood volume, such as those with congestive heart failure (CHF), to remove fluid. It is known in the art that when ultrafiltration is used to remove fluid from the blood, the fluid intended to be removed is located in the interstitial space. In addition, the rate of fluid flow from the interstitial space to the blood is unknown. The doctor can preset the total amount of fluid he wants to remove (usually calculated based on the patient's weight) and the minimum average CVP allowed. The system then removes fluid at a maximum rate that automatically maintains the desired CVP. That is, the system automatically balances the fluid removal rate with the fluid flow rate from the interstitial space to the blood.

It should be understood that normal CVP levels are 2 to 6 mmHg. A rise in CVP indicates excessive water load, while a fall in CVP indicates hypovolemia. The patient may start the ultrafiltration phase with a CVP above normal (e.g., 7 to 8 mmHg) and, after a treatment phase of, for example, 6 chambers, end the phase with a final CVP target of 3 mmHg. However, if, midway through the treatment phase, the CVP drops by more than 50% of the expected drop and the fluid removed only reaches 50% of the final removal target, the system can be reprogrammed to reduce the fluid removal target or reduce the fluid removal rate. Other actions can be taken based on more complex algorithms. The end result is to avoid hypovolemia by monitoring the rate and actual value of CPV. It should be understood that this method can also be used to control fluid removal rates not only during ultrafiltration but also for all types of renal replacement therapy.

FIG13 shows an exploded view of an extracorporeal blood treatment system 6900 configured to operate in a hemodialysis mode.

Blood circuit 6920 includes a peristaltic blood pump 6921, which draws impure blood from the patient's artery along tube 6901 and pumps it through dialyzer 6905. A syringe device 6907 injects an anticoagulant, such as heparin, into the drawn impure blood stream. A pressure sensor 6908 is provided at the inlet of blood pump 6921, while pressure sensors 6909 and 6911 are provided upstream and downstream of dialyzer 6905 to monitor the pressure at these vantage points.

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

The dialysate circuit 6925 includes two dual-channel pulsatile dialysate pumps 6926 and 6927. Dialysate pumps 6926 and 6927 pump spent dialysate solution from the dialyzer 6905 and regenerated dialysate solution from the reservoir 6934, respectively. When spent dialysate fluid from the dialyzer 6905 enters the dialysate circuit 6925, a blood leak sensor 6928 is provided to sense and prevent any leakage of blood into the dialysate circuit. Spent dialysate from the outlet of the dialyzer 6905 then passes through a bypass valve 6929 to reach a two-way valve 6930. A pressure sensor 6931 is disposed between valves 6929 and 6930. An ultrafiltration pump 6932 is provided in the dialysate circuit and periodically operates to pump ultrafiltration waste from the spent dialysate and store it in an ultrafiltration bag 6933, which is regularly emptied.

As previously described, a sorbent cartridge can be used to regenerate spent dialysate. The dialysate regenerated using the sorbent cartridge 6915 is recovered in a reservoir 6934. The reservoir 6934 includes a conductivity sensor 6961 and an ammonia sensor 6962. The regenerated dialysate flows from the reservoir 6934 through a flow restrictor 6935 and a pressure sensor 6936 to a two-way valve 6937. Depending on the patient's needs, a desired amount of infusion solution from the reservoir 6950 and/or concentrate from the reservoir 6951 can be added to the dialysis fluid. Infusion and concentrate are sterile solutions containing minerals and/or glucose that help maintain the levels of minerals such as potassium and calcium in the dialysate fluid as prescribed by the physician. A bypass valve 6941 and a peristaltic pump 6942 are provided to select the desired amount of infusion and/or concentrate and ensure that the solutions flow appropriately to the purified dialysate from the reservoir 6934.

The dialysate circuit includes two two-way valves 6930 and 6937. Valve 6930 directs one flow of spent dialysate to the first channel of dialysate pump 6926 and the other flow of spent dialysate to the first channel of dialysate pump 6927. Similarly, valve 6937 directs one flow of regenerated dialysate to the second channel of dialysate pump 6926 and the other flow of regenerated dialysate to the second channel of dialysate pump 6927.

A two-way valve 6938 is used to recover the streams of spent dialysate from pumps 6926 and 6927, while a two-way valve 6939 is used to recover the streams of regenerated dialysate from pumps 6926 and 6927. Valve 6938 combines the two streams of spent dialysate into a single stream that is pumped via a pressure sensor 6940 and passed through a sorbent cartridge 6915 where it is purified, filtered, and collected in a reservoir 6934. Valve 6939 combines the two streams of regenerated dialysate into a single stream that flows via a bypass valve 6947 to a two-way valve 6945. A pressure sensor 6943 and a dialysate temperature sensor 6944 are provided on the dialysate flow stream to the two-way valve 6945.

By reversing the states of the two-way valves 6930, 6937, 6938, and 6939, the operation of the two pumps 6926 and 6927 is reversed: one operates to withdraw dialysis fluid from the dialyzer 6905 and the other operates to supply dialysis fluid to the dialyzer 6905. As described above, this reversal, when performed periodically over short periods of time associated with a dialysis session, ensures that, over the longer period of time throughout the dialysis session, the volume of dialysate fluid pumped into the dialyzer is equal to the amount of fluid pumped out, and that the only total fluid volume lost by the dialysis circuit 6925 is the volume removed by the ultrafiltration pump 6932.

In hemodialysis mode, a two-way valve 6945 allows regenerated dialysate to enter the dialyzer 6905 to allow normal hemodialysis of the patient's blood. Closing one side of valve 6945 returns the patient's blood to the line. Another two-way valve 6946 serves as a backup, keeping the dialysate in the patient's blood line with both ports of valve 6946 closed even if valve 6945 leaks or fails.

FIG14 illustrates an alternative embodiment of a fluid circuit that does not utilize a backup two-way valve 6946. The blood circuit includes a peristaltic blood pump that draws impure blood from the patient's artery along tubing 7001 and pumps it through a dialyzer 7005. A syringe or pump 7007 injects an anticoagulant, such as heparin, into the drawn impure blood stream. A pressure sensor 7008 is located at the inlet of the blood pump, while pressure sensors 7009 and 7011 are located upstream and downstream of the organ segment. Purified blood from the dialyzer 7005 is pumped via tubing 7002 through a blood temperature sensor 7012, a degasser 7013, and an air (bubble) sensor 7014, and returned to the patient's vein. A pinch valve 7016 is also located before the patient's circuit connection to completely stop blood flow if air is sensed by an air (bubble) sensor 7014 on the upstream side of the tubing from the pinch valve 7016, thereby preventing air from reaching the patient.

The dialysate circuit includes two dialysate pump sections 7026 and 7027 in pressure-connected communication with the pump. Dialysate pump sections 7026 and 7027 pump spent dialysate solution from the dialyzer 7005 and regenerated dialysate solution from the reservoir 7034, respectively. Spent dialysate from the outlet of the dialyzer 7005 is pumped through a blood leakage sensor 7028 to a bypass valve 7029. Flow sensor 7030 is one of two flow sensors (the other being flow sensor 7046) that determine the volume of dialysate flowing through the circuit. Valve 7030 is structurally identical to a two-way valve and is used to bypass the dialysate pump 7026. Valve 7030 is normally closed in the bypass direction. When the dialysate pump 7026 is stopped, valve 7030 is opened to direct flow around the pump 7026. A pressure sensor 7031 is positioned between flow sensor 7030 and valve 7030. During normal flow, spent dialysate is pumped via pressure sensor 7040 and through sorbent cartridge 7015, where it is purified and filtered. The purified/filtered dialysate then enters reservoir 7034. Ultrafiltration pump 7032 operates periodically to extract ultrafiltration waste from the spent dialysate and stores it in an ultrafiltration bag (not shown) that is periodically emptied.

Regenerated dialysate from the reservoir 7034 passes through a flow restrictor 7035, a dialysate temperature sensor 7044, a flow sensor 7046, and a pressure sensor 7036 to reach a two-way valve 7045 via a bypass valve 7041. When the respective flow paths of the bypass valves 7029, 7045, and 7041 are activated, these flow paths direct the regenerated dialysate to bypass the dialyzer 7005. Infusion from the infusion reservoir 7050 and concentrate from the concentrate reservoir 7051 are directed by an infusion pump segment 7042 and a concentrate pump segment 7043 to the purified dialysate originating from the reservoir 7034 and the spent dialysate downstream of the flow sensor 7030, respectively.

Two-way valve 7045 determines which mode the system is working in. Thus, in one operating mode, two-way valve 7045 enables regenerated dialysate to enter the dialyzer so that normal hemodialysis can be performed on the patient's blood. In another operating mode, two-way valve 7045 is actuated to direct the fluid flow of ultrapure infusion-grade dialysate to the venous blood line and directly to the patient. Therefore, the multifunctional valve enables the operating mode to switch between hemofiltration and hemodialysis. For example, in hemofiltration, infusion-grade fluid is sent directly to the bloodstream via three valves, wherein in this bloodstream, valve 6946 is connected to the rear dialyzer. In this mode, valve 6945 prevents the dialysate fluid from entering the lower port of the dialyzer. In the hemodialysis shown in Figure 13, valve 6946 is closed and valves 6947 and 6945 send the dialysate fluid to the dialyzer. It should be noted that the embodiment of FIG. 13 uses pump switching and multiple valves to control fluid volume, while the embodiment of FIG. 14 uses flow sensors 7030 and 7046 to control fluid volume.

As discussed above, preferably, the valve is implemented in the manifold using an elastic membrane at a flow control point that is selectively blocked as needed by a protrusion, pin or other member extending from the manifold. In some cases, a safe low-energy solenoid valve can be used for fluid blocking.

The valve system includes a lightweight and minimally powered magnetic displacement system, making it ideal even in portable renal dialysis systems using disposable manifolds for the fluid circuit. The system can be used in conjunction with orifices of any structure. In particular, the orifice can be any hole, opening, gap, or dividing wall of any material. This includes passages, manifolds, disposable manifolds, channels, and other passages in a piping system. One of ordinary skill in the art will appreciate that the currently disclosed valve system can be implemented using a disposable manifold by configuring the displacement members and magnets, as discussed further below, at any desired valve position outside the manifold. The actuator is also independent of and distinct from the disposable manifold and is typically part of the non-disposable portion of the renal dialysis system.

Functionally, the valve has two stable states: open and closed. The valve operates by using magnetic force to move the displacement member against the diaphragm, thereby creating sufficient force to press the diaphragm against the valve seat and close the orifice. Closing the orifice shuts off fluid flow. The reverse process (i.e., using magnetic force to move the displacement sensor away from the diaphragm, thereby releasing the diaphragm from pressure against the valve seat) opens the orifice and allows fluid flow.

FIG15 is a flow chart illustrating another process 8000 for starting a dialysis treatment. A controller unit 8001 may include at least one processor and a memory storing a plurality of programming instructions. These programming instructions, when executed by the processor, generate a plurality of graphical user interfaces displayed on a controller display that guides a user through a series of operations designed to reliably obtain and measure the additives required for a dialysis treatment. A first graphical user interface is generated through which a user can prompt the system to begin an additive accounting process (8001). This initial prompt may occur via a specific icon for starting the process or as part of a larger system setup.

A second graphical user interface is then generated (8003), wherein the second graphical user interface displays the desired additive in text or graphical form (preferably including a visual image of the actual additive package) to allow the user to visually compare the desired additive with the product the user already has. The user is then prompted (8005) to indicate whether he wishes to use barcode scanning or verify the additive by weight. If the user indicates that he wishes to use barcode scanning, for example by pressing an icon, a third graphical user interface is generated (8007), prompting the user to pass the first additive through a barcode scanner. The user then passes the additives through the barcode scanner, preferably in any order, to register the read. It should be understood that the barcode scanner may include a light, such as a red light, wherein the light changes color to, for example, green, upon a successful read.

If the system successfully reads the barcode, the system processes (8009) the code by checking it against a table stored in memory. The table stored in memory associates the barcode with a specific additive. Once the specific additive is identified, the second graphical user interface described above is updated (8011) with a check mark or highlight to indicate which additive was successfully scanned and instruct the user to select that additive. This process is repeated (8019) for all additives. In one embodiment, once all additives are highlighted or selected, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, once all additives are highlighted or selected, the system presents a graphical user interface that notifies the user that all additives have been registered, after which the user manually causes the system to proceed to the next step in the dialysis setup or initialization process. It should be understood that although the term barcode is used, any electronic tagging or labeling system including, for example, a radio frequency identification (RFID) tag may be used.

If, for any of the scanning steps 609, no barcode is recognized, the additive does not have a barcode, or the user prefers to use weighing rather than scanning to verify the additive, a graphical user interface is presented to the user (8013) prompting the user to place the first additive on the scale. The scale measures the weight of the additive package (8015) and compares the measured weight to a table of weight values associated with specific additives to identify the additive. Once the additive is identified, the second graphical user interface described above is updated (8017) with a check mark or highlight to indicate which additive was successfully scanned and instruct the user to select that additive. This process is repeated (8019) for all additives. In one embodiment, once all additives are highlighted or selected, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, once all additives are highlighted or selected, the system presents a graphical user interface notifying the user that all additives have been registered, after which the user manually causes the system to proceed to the next step in the dialysis setup or initialization process. It should be understood that although the term barcode is used, any electronic labeling or tagging system can be used.

If no additive is identified, the user is informed that the additive is not part of the therapeutic process and is prompted to weigh the appropriate additive. In another embodiment, if the user is unable to scan or weigh the identified additive, the user is not allowed to continue with the initialization or setup process.

One of ordinary skill in the art will appreciate that while the above verification process has been described for prescription additives, the same process can be extended to disposable components used with dialysis systems, such as sorbent cartridges and other disposables.

It should also be understood that the process of scanning and weighing the additive can be integrated and automated. As discussed above, the user can be prompted to begin the additive weighing process and a display of the items required for treatment can be displayed. The user can place the additive on a scale that has a barcode reader nearby or integrated within it. In one embodiment, the user is prompted to place the additive in a specific location or structure to ensure that the barcode can be properly read. When the additive is placed on a scale with an integrated or combined barcode reader, the barcode reader scans the additive, attempts to recognize the barcode, and, if the barcode is recognized, processes the item by selecting or highlighting the identified additive on the display. If the barcode does not identify the additive, if the system requires additional auxiliary checks, or if the system wishes to obtain or record weight information, the scale measures the weight and attempts to identify the additive by comparing it to a stored value. If the additive is recognized, the system processes the item by selecting or highlighting the identified additive on the display. Thus, scale measurements and barcode reader operations can occur without having to move the additive from one location to another.

It should also be understood that the additives can be inserted into a holding container, tank, vat, box, barrel, or temporary storage area that will automatically drop, place, or position each additive in the appropriate position on the scale/barcode reader. Thus, the user can place all additives in a single container, activate the system, and have each additive positioned on the scale and automatically identified. The user can be prompted to remove each additive after it is identified, or the user can be prompted so that all additives can be processed first.

It will also be appreciated that additives 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 top or bottom unit of the portable dialysis system also preferably has an electronic interface such as an Ethernet connection or a USB port to enable direct connection to a network, thereby facilitating remote prescription verification, compliance alerts, and other remote service operations. The USB port also allows for direct connection to accessory products such as a blood pressure monitor or hematocrit/saturation monitor. These interfaces are electronically isolated, thereby ensuring patient safety regardless of the quality of the interfacing device.

In another embodiment, the dialysis machine includes an interface in the form of a graphical user interface having touch screen buttons, a physical keypad, or a mouse, wherein the interface can be operated to cause the dialysis machine equipped with the manifold to begin operating in a treatment mode or a perfusion mode. Where operation in the treatment mode is indicated, the controller (in response to the treatment mode command) generates a signal to switch the manifold valve from an open perfusion state to a closed treatment state. Where operation in the perfusion mode is indicated, the controller (in response to the perfusion mode command) generates a signal to switch the manifold valve from a closed treatment state to an open perfusion state. One of ordinary skill in the art will appreciate that all of the above-described control and user command functions are implemented by including one or more processors to execute programming embodying the above-described instructions stored in local memory.

When properly activated, the system can operate in at least a perfusion mode and a therapy mode, where the therapy mode can include other modes of operation such as hemodialysis, hemofiltration, or simply a non-perfusion mode.

Embodiments of the dialysis system disclosed herein can be designed to utilize multiple disposable components. The disposable items used in the system can be shipped in pre-assembled packaging on a tray. The tray can be placed above the workspace of the controller unit, allowing easy access to and management of the required disposable items, which is particularly important inside a vehicle. The controller unit can be waterproof so that, in the event of a liquid spill, the liquid will not penetrate and damage the controller unit.

In the exemplary embodiment shown in Figure 16, there is provided a disposable kit 8200 that includes a manifold 8202, a dialyzer 8201, and tubing 8203 all pre-installed. Referring to Figure 16, the disposable kit 8200 includes the dialyzer 8201, the manifold 8202, the tubing 8203, the valve 8204 (as part of the manifold), and the reservoir bag 8205, all pre-attached and configured to be installed directly into the dialysis machine by the user.

Disposable components (especially completely disposable blood circuits and dialysate circuits) can be pre-packaged in a kit (including dialyzers, manifolds, piping, reservoir bags, ammonia sensors and other components) and can then be installed by the user by opening the front door of the unit, installing the dialyzer and installing the manifold in a manner that enables alignment with non-disposable components such as pressure sensors and other components. Multiple pump seats integrated into the inner surface of the front door make it easy to load the disposable components. Only the manifold needs to be inserted and there is no need to pass the pump piping system between the rollers and the pump seats. This simple packaging method makes it easy and quick to load and clean the system in a disposable manner. It also ensures that the flow circuit is properly configured and ready for use. In operation, a separate unit, container, luggage compartment, glove box or small cabin can be set to accommodate the reservoir.

17 , a dialysis system 8400 operating in dialysis mode includes a dialyzer 8402, a sorbent regeneration system (e.g., a cartridge) 8412, a manifold 8410, a fluid source 8416 that enters the manifold 8410 via a port, and a reservoir 8415 through which fresh dialysate is input back into the manifold 8410 via a port. In operation, blood enters blood line 8401, enters the manifold 8410 via a port, passes through a two-way valve 8421 in a first position, and enters the dialyzer 8402. Cleansed blood exits the dialyzer 8402 via an outlet 8403, passes through a two-way valve 8422 in a first position, and enters the manifold 8410 via a port. The blood passes through the manifold, through the various valves associated with the manifold 8410 as described above, out of the port, and into the patient's blood line 8423.

At the same time, infusate flowing from source 8416 flows into manifold 8410 via a port, passes through manifold 8410, flows out via another port, and enters reservoir 8415, from which dialysate is delivered via dialysate inlet line 8424 and enters dialyzer 8402. After passing through dialyzer 8402, the dialysate passes through outlet line 8425 and returns to manifold 8410 via a port, where it is sent via a port to sorbent-based dialysate regeneration system 8412. If and when needed, regenerated dialysate flows back through manifold 8410 via a port and circulates with new dialysate through dialyzer 8402. To manage dialysate fluid flow, reservoir 8415 is used to store regenerated dialysate if and when needed. In some embodiments, the reservoir can hold 5 liters of dialysate and has the capacity to hold up to 10 liters of dialysate and effluent from the patient.

18 , a dialysis system 8500 operating in a perfusion mode includes a dialyzer 8502, a sorbent regeneration system (e.g., a cartridge) 8512, a manifold 8510, an infusion source 8516, and a reservoir 8515. In operation, the blood line from the patient (e.g., 8401 in FIG. 17 ) to the manifold 8510 is not connected, and therefore, no blood is flowing, or is able to flow, into the manifold 8510. Instead, dialysate delivered from the source 8515 is delivered to the manifold 8510 via a plurality of ports and via a dialysate inlet line 8524, which is connected to a two-way valve port 8522.

A single two-way valve can be incorporated into the physical body of the manifold and can be operated to switch between a treatment mode of operation and a perfusion mode of operation. In this embodiment, the manifold includes a two-way valve that, upon activation or switching from a first position (e.g., closed) to a second position (e.g., open), causes a change in the internal flow path of fluid within the manifold. As a result of this flow path change, the blood circuit and the dialysate circuit, which were fluidically isolated from each other when the valve was closed, are now in fluid communication with each other. Preferably, no additional valves or switches need to be operated to achieve this state change, i.e., to cause the separate blood circuit and dialysate circuit to become fluidically connected.

Valve switching can be achieved by any means known in the art, including by physically operating a mechanical control on the surface of the manifold, or by electronically changing the valve state through operation of the dialysis machine via an interface between the dialysis machine and a valve interface integrated into the surface of the manifold for controlling the state of the valve according to an operating mode selected by the user.

In prime mode, the valve will open, allowing dialysate fluid to flow through the pump, through the manifold, into the dialyzer, out of the dialyzer, back into the manifold, and out of the manifold. Thus, in prime mode, the valve ensures that dialysate circulates through the blood circuit, thereby placing the blood circuit and the dialysate circuit in fluid communication. Functionally, the manifold is placed in prime mode by manipulating the state of the two-way valve.

After a specified volume of dialysate is pumped into and through the blood circuit, the two-way valve closes. Dialysate pumping may or may not continue. If continued, fresh dialysate circulates only through the dialysate circuit. Residual dialysate remains in the blood circuit. To purify dialysate from the blood circuit, the patient is connected to the "from-patient line" 8401, shown in FIG84 and commonly referred to as the venous access line. The "to-patient line" 8423, commonly referred to as the venous return line, is maintained above a waste container or connected to the patient.

With the system in treatment mode, blood from the patient is drawn into the blood circuit, transferred to the manifold, passed through the pump, exited the manifold, passed through the dialyzer, returned to the manifold, and then exited the manifold in the opposite direction. The blood is thus allowed to "track" residual perfusion fluid through the blood circuit, removing any residual air pockets in the process, and, depending on the connection status of the venous return line, enter a waste container or the patient. After the blood completely fills the blood circuit, the system stops the blood pump or the user manually stops it. If the venous return line is not already connected, it is then connected to the patient and treatment continues.

In another embodiment, a filter such as a 0.22 mu filter can be used to help remove any remaining unwanted substances in the event that the sorbent canister is insufficient to produce a substantially sterile dialysate. As an example, the filter is configured in line with the reservoir input line, near port E of the manifold, and is used during priming and operation.

By using this priming system, the need for an additional, separate set of disposables to prime only the blood side of the circuit is avoided. In particular, this method eliminates the need for a separate source of saline, such as a 1-liter bag of saline, and thus also eliminates the need for a connector and tubing system to a separate source of saline, including a double-lumen spike or a single-lumen spike for connecting the blood line to the saline.

FIG19 shows, among other elements, a disposable conductivity sensor 8690 comprising a tubular portion having a first end for receiving a first disposable tubing segment and a second end for receiving a second disposable tubing segment. The tubular portion includes a plurality of first probes extending into an interior volume defined by the tubular portion and forming a fluid flow path. In one embodiment, at least three separate elongated probes are employed. In another embodiment, at least four separate elongated probes are employed.

The disposable conductivity sensor 8690 is configured to be attached to a plurality of complementary and matching second detectors, wherein these plurality of second detectors are fixedly and/or permanently attached to the external side of the control unit. The attachment site may include a portion on the outer surface of the control unit that is close to the dialyzer or located on the same side as the dialyzer. In operation, the disposable conductivity sensor 8690 is snapped into the complementary and matching non-disposable detectors in a temporary but attached relationship. Therefore, these plurality of second detectors are accommodated in the plurality of first detectors and are positioned to communicate with the plurality of first detectors. These detectors then operate by emitting and detecting signals in the fluid flow path defined by the first disposable tubing system segment, the tubular portion of the conductivity sensor, and the second disposable tubing system segment, and then sending the detected signals to the memory and processor in the control unit for use in monitoring and controlling the dialysis system.

Referring to FIG19 , a method and system for safely and efficiently performing a saline backflush is shown. Conventionally, saline backflush for flushing a system using saline is performed by removing tubing segment 8658 that connects the dialysis blood circuit to the patient at connection 8651 and attaching tubing segment 8658 to saline source 8602 via connection points 8652 and 8653. However, this conventional method has drawbacks, including violations of sterile connections. It should be understood that the connection point can be any type of connection, including a Luer connection, a snap-on connection, a needleless insert, a valve, or any other form of fluid connection.

Another method for performing a saline backflush includes connecting a saline source 8602 to connection point 8653 via connection point 8652 while maintaining a connection to the patient. While this avoids a breach of the sterile connection, it exposes the patient to saline fluid flow. Therefore, a preferred method for performing a saline backflush is to maintain a connection between the patient and the dialysis system via tubing segment 8658, wherein tubing segment 8658 is connected to the manifold 8600 at port C 8605, connected to the patient at connection point 8651, and fluidly connecting the saline source 8602 to the manifold 8600 at port D 8606. While the patient is still fluidly connected to the dialysis system, saline is allowed to flow into the manifold 8600 via port D 8606, which is adjacent to port C 8605, by gravity or applied pressure. The saline flow is used to flush the manifold 8600 with saline, and in particular, flows from the manifold 8600 via port C 8605, through tubular segment 8658, and into the patient via connection 8651. Because a bubble detector is present in region 8654 near port C 8605, if the manifold 8600 is installed in a controller unit and is therefore configured to detect bubbles in the fluid flow exiting port C 8605, the saline exiting the manifold 8600 and toward the patient will be monitored for bubbles via the bubble detector in region 8654. If bubbles are detected, a low-level alarm will be issued, thereby signaling the patient that they should disconnect from the system or extract the bubbles from access point 8610 using a syringe. Thus, this method and system for performing a saline backflush maintains a sterile connection while still detecting and alarming for the presence of bubbles.

The full contents of all references cited in the present disclosure are incorporated herein by reference in their entirety. In addition, when amount, concentration or other values or parameters are given as a list of ranges (preferred ranges) or upper preferred values and lower preferred values, it should be understood that specifically discloses the full range consisting of any to any upper limit or preferred value and any lower limit or preferred value, regardless of whether the scope is disclosed separately. In the case of enumerating numerical ranges herein, unless otherwise stated, scope is intended to include all integers and fractions within its endpoints and ranges. It is not intended that the scope of the present invention is limited to the specific values cited when defining the range.

Other aspects of the invention will be apparent to those skilled in the art by considering the specification and examples of the invention disclosed herein. It is intended that the specification and examples be considered only as examples within the true scope and spirit of the invention as indicated by the appended claims and their equivalents.

Transportation

Technical Field

Background Art

Summary of the Invention

BRIEF DESCRIPTION OF THE DRAWINGS

FIG10 is a diagram of an exemplary disconnect monitoring system;

FIG11 is a flow chart defining an exemplary disconnection detection process;

DETAILED DESCRIPTION

Port A 3315 - blood to dialyzer 430;

Port B 3316 - dialyzer output (spent dialysate);

Port C 3317 - blood from the patient;

Port D 3318 - for heparin mixed into blood;

Port E 3319 - Reservoir output (fresh dialysate);

Port F 3320 - dialyzer input (fresh dialysate);

Port G 3321 - dialyzer output (blood);

Port H 3322 - Patient return (clean blood);

Port J 3323 - connected to the irrigation and drain lines;

Port K 3324 - Reservoir infusion input;

Port M 3325 - infusion fluid entry from infusion fluid reservoir; and

Port N 3326 - Dialysate flow to sorbent.

Claims

1. A means of transportation, comprising:

Transportation navigation system;

Fuel and/or battery energy sources;

sensor;

A dialysis machine configured to perform dialysis treatment on a patient while the vehicle is in operation, the dialysis machine including a control unit configured to receive signals from the sensors and calculate the amount of energy required for the vehicle and the dialysis machine to work together for the time required to complete the dialysis treatment; and

Provides an interface for electrical communication between the dialysis machine and the vehicle navigation system.

2. The vehicle of claim 1, wherein the vehicle navigation system includes a first input device for a user to input a desired destination and is configured to receive destination input, the vehicle navigation system is configured to calculate the travel time required for the vehicle to reach the desired destination, the dialysis machine includes a second input device for a user to input a prescription therapy and is configured to receive prescription therapy input for the dialysis treatment, and the control unit is configured to calculate the treatment rate required to complete the input prescription therapy within the travel time calculated by the vehicle navigation system.

3. The vehicle according to claim 1, further comprising: a vehicle electrical system; a vehicle battery; an alternator for charging the vehicle battery during operation of the vehicle; and a backup battery for the dialysis machine, wherein: the backup battery is in electrical communication with the alternator, and the vehicle electrical system is configured to charge the backup battery during operation of the vehicle.

4. The vehicle according to claim 3, wherein the vehicle electrical system comprises: an ignition switch; and an ignition switch bypass circuit configured to supply battery power from the backup battery to the dialysis machine when the ignition switch is off.

5. The vehicle of claim 1, wherein the dialysis machine further comprises at least one blood pump and an alarm system configured to stop operation of the at least one blood pump in response to receiving a low-level alarm signal, and the vehicle navigation system configured to navigate the vehicle to the nearest emergency center in response to receiving an emergency alarm signal from the alarm system.

6. The vehicle of claim 1, further comprising: an engine and a dialysis control unit for the dialysis machine, wherein the fuel and/or battery energy source includes a fuel source for the engine, and the sensor includes a fuel sensor configured to sense the amount of fuel available for the engine; the dialysis control unit includes a user interface configured to allow a user to input a prescription therapy into the dialysis machine, the interface between the dialysis machine and the vehicle navigation system including electrical communication between the fuel sensor and the dialysis control unit for the dialysis treatment, wherein the prescription therapy includes a value of the amount of time required to perform the prescription therapy, the fuel sensor is configured to send a signal indicating the amount of fuel available to power the engine to the dialysis control unit, and the dialysis control unit is configured to notify the user if there is insufficient fuel to power the engine within the amount of time required to perform the prescription therapy.

7. The vehicle of claim 1, further comprising: a battery-powered motor and a dialysis control unit for the dialysis machine, wherein the fuel and/or battery energy source includes a battery configured to supply battery power to the motor, and the sensor includes a battery sensor configured to sense the amount of battery power available to the motor; the dialysis control unit includes a user interface configured to allow a user to input a prescription therapy into the dialysis machine, the interface between the dialysis machine and the vehicle navigation system includes electrical communication between the battery sensor and the dialysis control unit for the dialysis treatment, wherein the prescription therapy includes a value of the amount of time required to perform the prescription therapy, the battery sensor is configured to send a signal indicating the amount of battery power available to power the motor to the dialysis control unit, and the dialysis control unit is configured to notify the user if the battery power available to power the motor is insufficient for the amount of time required to perform the prescription therapy.

8. The means of transport according to claim 1, wherein the means of transport includes an automobile.

9. The vehicle according to claim 1, wherein the energy source comprises fuel, battery power, or a combination thereof.

10. The vehicle of claim 1, wherein the control unit is configured to notify the user if there is insufficient energy to power the vehicle for the time required to complete the dialysis treatment.