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PUMP CASSETTE AND METHODS FOR USE IN SYSTEM OF

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INDUSTRIAL <o

MX/a/2021/007240

MEDICAL TREATMENT THROUGH THE USE OF A PLURALITY OF

FLUID LINES

BACKGROUND OF THE INVENTION

Peritoneal dialysis (PD) involves the periodic infusion of a sterile aqueous solution (called peritoneal dialysis solution or dialysate) into a patient's peritoneal cavity. Exchanges by diffusion and osmosis take place between the solution and the bloodstream across the body's natural membranes. These exchanges transfer waste products to the dialysate, which the kidneys would normally excrete. Waste products typically consist of solutes such as sodium and chloride ions and other compounds normally excreted through the kidneys, such as urea, creatinine, and water. The diffusion of water across the peritoneal membrane during dialysis is called ultrafiltration.

Conventional peritoneal dialysis solutions include dextrose in concentrations sufficient to generate the osmotic pressure necessary to remove water from the patient through ultrafiltration.

Continuous ambulatory peritoneal dialysis (CAPD) is a common form of peritoneal dialysis. A patient performs CAPD manually approximately four times a day. During a drain/fill procedure for CAPD, the patient initially drains spent peritoneal dialysis solution from their

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INDUSTRIAL <or peritoneal cavity, and then infuses fresh peritoneal dialysis solution into the peritoneal cavity. This drainage and filling procedure usually takes approximately 1 hour.

Automated peritoneal dialysis (APD) is another common form of PD. APD uses a machine, called a cycler, to automatically infuse, reside, and drain peritoneal dialysis solution into and from the patient's peritoneal cavity. APD is particularly attractive to PD patients because it can be performed overnight while the patient is asleep. This frees the patient from the day-to-day requirements of continuous active peritoneal dialysis (CAPD) during their waking and working hours.

The APD sequence typically lasts several hours. It often begins with an initial drainage phase to empty the peritoneal cavity of spent dialysate. The APD sequence then proceeds through a succession of filling, residing, and draining phases, one after the other. Each filling/residencing/draining sequence is called a cycle.

During the filling phase, the cycler transfers a predetermined volume of warm, fresh dialysate into the patient's peritoneal cavity. The dialysate remains (or "resides") within the peritoneal cavity for a period of time. This is called the residence phase. During the drainage phase, the cycler removes the spent dialysate from the peritoneal cavity.

The number of fill/residence/drain cycles required during a given APD session depends on the total volume of dialysate prescribed for the patient's APD regimen and whether it is introduced

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INDUSTRIAL <o as part of the treatment prescription or is calculated by the cycler.

APD can be and is practiced in different ways.

Continuous cycling peritoneal dialysis (CCPD) is a commonly used type of active peritoneal dialysis (APD). During each fill/residence/drain phase of CCPD, the cycler infuses a prescribed volume of dialysate. After a prescribed residence period, the cycler completely drains this volume of fluid from the patient, leaving the peritoneal cavity empty, or “dry.” Typically, CCPD uses 4–8 drain/residence/drain cycles to achieve a prescribed therapy volume.

After the last prescribed fill/residence/drain cycle in CCPD, the cycler infuses a final fill volume. This final fill volume remains in the patient for an extended period. Drainage occurs either at the start of the next CCPD session in the evening or during a midday exchange. The final fill volume may contain a different concentration of dextrose than the fill volume of successive CCPD fill/residence/fill cycles provided by the cycler.

Intermittent peritoneal dialysis (IPD) is another modality of

APD. IPD is typically used in acute situations, when a patient suddenly enters dialysis therapy. IPD can also be used when the patient requires PD but cannot assume the responsibilities of CAPD or otherwise manage it at home.

Like CCPD, IPD involves a series of fill/residence/drain cycles. Unlike CCPD, IPD does not include a phase

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INDUSTRIAL <o of final fill. In IPD, the patient's peritoneal cavity is free of dialysate (or "dry") between APD therapy sessions.

Physiological variation peritoneal dialysis (PPD) is another type of APD. Like CCPD, PPD involves a series of fill/residence/drain cycles. Unlike CCPD, PPD does not completely drain the dialysate from the peritoneal cavity during each drainage phase. Rather, PPD establishes a baseline volume during the first fill and drains only a portion of this volume during the first drainage phase. Subsequent fill/residence/drain cycles infuse and then drain a replacement volume on top of the base volume. The final drainage phase removes all dialysate from the peritoneal cavity.

There is a variation of TPD that includes cycles during which the patient is completely drained and infused with a new full-baseline dialysis volume.

TPD may include a final fill cycle, such as CCPD. Alternatively, TPD may omit the final fill cycle, such as IPD.

APD offers increased flexibility and improved quality of life for individuals requiring dialysis. APD can relieve patients of the fatigue and inconvenience that daily CAPD (Continuous Autopsy and Dialysis) can cause for some. APD can allow patients to return to their waking hours and work without the need to drive to dialysis exchanges.

However, the complexity and size of the machines

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INDUSTRIAL <o previous and disposable associated for various APD modalities have prevented widespread patient acceptance of APD as an alternative to manual peritoneal dialysis methods.

BRIEF DESCRIPTION OF THE INVENTION

Aspects of the invention relate to various components, systems, and methods for use in medical applications, including medical infusion operations such as peritoneal dialysis. In some cases, aspects of the invention are limited to applications in peritoneal dialysis, while others relate to more general dialysis applications (e.g., hemodialysis) or infusion applications, while still others relate to more general methods or processes. Therefore, aspects of the invention are not necessarily limited to APD systems and methods, although many of the illustrative embodiments described relate to APD.

In one aspect of the invention, a disposable fluid handling cassette, such as one usable with an APD cycler device or other infusion apparatus, includes a generally flat body having at least one pump chamber formed as a depression on a first side of the body and a plurality of fluid flow paths including a channel. A patient line port may be arranged for connection to a patient line and be in fluid communication with at least one pump chamber via at least one flow path, and a

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INDUSTRIAL <o membrane may be fixed to the first side of the body over at least one pump chamber. In one embodiment, the membrane may have a pump chamber portion with a non-tensioned shape that generally conforms to the pump chamber depression in the body and is arranged to be movable for fluid movement into usable space of the pump chamber. If the cassette body includes two or more pump chamber depressions, the diaphragm may also include two or more pre-configured pump sections. In other configurations, the diaphragm does not need to be included with the cassette, e.g., where a cycler control surface interacts with the cassette to control pumping and/or valve functions.

In another embodiment, the pump chamber may include one or more separator elements extending from an inner wall of the depression, e.g., to help prevent the diaphragm from making contact with the inner wall, thus preventing the blockage of an inlet/outlet of the pump chamber, helping to remove or trap air in the pump chamber, and/or preventing the diaphragm from sticking to the inner wall. The spacer elements can be arranged to minimize deformation of the membrane at the edges of the spacer elements when the membrane is forced against the spacer elements.

In another embodiment, a patient line port and a drain line port may be located at one end of the body and be in fluid communication with at least one pump chamber

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INDUSTRIAL <o by means of at least one flow path. A plurality of solution line spigots, on the other hand, may be located at a second end of the body opposite the first end, with each of the solution line spigots being in fluid communication with at least one pump chamber by means of at least one flow path. This arrangement may enable automated connection of solution lines to the cassette, and/or isolate the occlusion of the patient and/or drain lines from the solution lines. In one modality, a heater bag line port may also be located at the first end of the body and be in fluid communication with at least one pump chamber via at least one flow path. The flexible patient, drain, and heater bag lines can be connected respectively to the patient line port, drain line port, and heater bag line port.

In another embodiment, the body may include a vacuum vent free space depression formed adjacent to at least one pump chamber. The depression may aid in the removal of fluid (gas and/or liquid) between the diaphragm and a corresponding control surface of the cycler, e.g., by means of a vacuum port in the control surface. In other words, the depression can help ensure that the membrane is forced against the vacuum port, leaving the port open to draw fluid into a collection chamber as needed.

In one modality, one or more ports, such as a port of

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INDUSTRIAL <o drain line and a heater bag line port, and/or one or more solution line spigots may communicate a common flow path channel from the cassette base. As required, a plurality of valves may each be arranged to control flow in a respective flow path between at least one pump chamber and the patient line port, the drain line port, and the plurality of solution line spigots. In one embodiment, portions of the membrane may be positioned over respective valves and be movable to open and close the respective valve. Similarly, the flow through the openings into the pump chamber(s) may be controlled by corresponding valves that are opened and closed by the movement of one or more portions of the membrane.

In some embodiments, the membrane can close at least some of the body's flow paths. That is, the body can be formed with open flow channels that are closed on at least one side by the membrane. In one embodiment, the body can include flow paths formed on opposite flat sides, and at least some of the flow paths on one side can communicate with flow paths on the other side.

In one modality, one or more pins on the cassette (e.g., to receive dialysate solution) can be covered by a pin cap that seals the pin closed and is removable.

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In another aspect of the invention, a fluid handling cassette

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INDUSTRIAL <or disposable, for use with a reusable automated peritoneal dialysis cycler device, includes a generally flat body having at least one pump chamber formed as a depression on a first side of the body and a plurality of fluid flow paths including a channel, a patient line port disposed for connection to a dialysis line, the patient line port being in fluid communication with at least one pump chamber by means of at least one flow path, and a flexible membrane attached to the first side of the body over at least one pump chamber. A portion of the membrane pump chamber over at least one pump chamber may have a non-tensioned shape that generally conforms to the usable area of ​​the pump chamber depression in the body and may be arranged to be movable for fluid movement within the pump chamber. In one embodiment, the cassette is configured for operational engagement with a reusable, automated peritoneal dialysis cycler device.

The cassette may include a drain line port arranged for connection to a drain line, the drain line port being in fluid communication with at least one pump chamber by means of at least one flow path, and/or a plurality of solution line spigots that are in fluid communication with at least one pump chamber by means of at least one flow path. The pump chamber portion of the membrane can generally be dome-shaped, and may include two pump chamber portions that have

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INDUSTRIAL <o a shape that generally conforms to the usable area of ​​a corresponding pump chamber depression. In one embodiment, a pump chamber portion volume may be between 85-110% of the usable volume of the pump chamber depression. In another embodiment, the pump chamber portion may be arranged to be 85-110% of the depth of the usable area of ​​the pump chamber depression. In another embodiment, the pump chamber portion may be arranged to have a size that is between 85-100% of the circumference of the usable area of ​​the pump chamber depression. The usable area of ​​the pump chamber may be defined, at least in part, by one or more separating elements extending from an internal wall of the depression. In one embodiment, a plurality of separating elements may be of graduated lengths or variable heights, defining a region generally in the shape of a dome or other form. The separating elements may be arranged in a concentric elliptical pattern or other shape when viewed in plan. One or more breaks in the pattern may be provided, e.g., to allow communication between openings. In one embodiment, the spacer elements may be arranged to minimize membrane deformation at the edges of the spacer elements when the membrane is forced against them. In another embodiment, one or more spacers may be configured to prevent the membrane from covering the fluid inlet and/or outlet of the pump chamber.

In another aspect of the invention, a fluid handling cassette

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INDUSTRIAL <o for use with a fluid handling system of a medical infusion device includes a generally flat body having at least one pump chamber formed as a depression on a first side of the body and a plurality of flow paths for fluid including a channel, at least one pump chamber includes one or more separator elements extending from the inner wall of the depression, a patient line port arranged for connection to a patient line, the patient line port being in fluid communication with at least one pump chamber via at least one flow path, a drain line port arranged for connection to a drain line, the drain line port being in fluid communication with at least one pump chamber via at least one flow path, and a plurality of solution line spikes being in fluid communication with at least one pump chamber by means of at least one flow path.

In one aspect of the invention, a disposable component system for use with a fluid line connection system of a peritoneal dialysis system includes a fluid handling cassette having a generally flat body with at least one pump chamber formed as a depression on a first side of the body and a plurality of flow paths for fluid, a solution line spigot located at a first end of the body, the solution line spigot being in fluid communication with at least one pump chamber by means of

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INDUSTRIAL <or at least one flow path, and a spigot cap configured to removably cover the solution line spigot. Wherein the cap includes at least one raised feature (e.g., an asymmetric or symmetric tab) to aid in removing the cap for connection to a solution line prior to the commencement of peritoneal dialysis therapy.

In one embodiment, the cassette includes a skirt arranged around the tenon to receive one end of the tenon cap, and there may be a depression between the skirt and the tenon that are arranged to aid in forming a seal between the tenon cap and the skirt.

In another embodiment, a solution line cap may be removably connected to a solution line, and the solution line cap may include a recessed feature (such as a symmetrical or asymmetrical groove). At least a portion of the solution line cap may include a flexible material, such as silicone rubber. The recessed feature may aid in the removal of a spigot cap from the cassette.

In another configuration, the spike cap includes a second raised feature that can function as a stop for the solution line cap.

In another embodiment, a main axis of one or more pins is in a plane substantially the same as the generally flat body of the fluid handling cassette.

In another aspect of the invention, a fluid handling cassette for use in a peritoneal dialysis system includes a body

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INDUSTRIAL <or generally flat with at least one pump chamber formed as a depression on a first side of the body and a plurality of flow paths for fluid, and a spigot located at a first end of the body for attachment to a dialysate solution line. The spike may be in fluid communication with at least one pump chamber by means of at least one flow path that includes a distal tip and a lumen arranged such that the distal tip of the spike is located substantially close to the longitudinal axis of the spike. In one embodiment, the lumen may be located substantially off the longitudinal axis.

In another aspect of the invention, a disposable component system for use with an in-line fluid connection system of a peritoneal dialysis system includes a spigot cap configured to removably cover a spigot of a fluid handling cassette. The cap may include at least one feature to aid in removing the cap for connection to a solution line prior to the commencement of peritoneal dialysis therapy. The feature can be a raised feature, or a depressed feature, and can be configured for engagement with a solution line cap.

In another aspect of the invention, a disposable component system for use with a fluid line connection system of a peritoneal dialysis system includes a solution line cap for removable attachment to a solution line, wherein the solution line cap includes at least one feature to aid in the removal of

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INDUSTRIAL <o a spigot cap to enable the connection between a solution line and a spigot before starting peritoneal dialysis therapy. The feature may be a raised feature, or a recessed feature and may be configured to engage with a spigot cap. Evidence may be associated with a solution line, e.g., so that a solution associated with the line can be identified and affect at least one function of the peritoneal dialysis system.

In another aspect of the invention, a medical fusion fluid handling system, such as an APD system, may be arranged to uncap and connect one or more lines (such as solution lines) with one or more spigots or other connection ports on a flow handling cassette. This feature may provide advantages, such as a reduced likelihood of contamination since no human interaction is required to uncap and connect the lines and spigots. For example, an APD system may include a cart arranged to receive a plurality of solution lines, each of which has a connector end and a cap. The cart may be arranged to move along a first direction in order to move the connector ends of the solution lines along that direction, and a separator may be arranged to engage the caps on the solution lines in the cart. The lid separator can be arranged to move in a second direction perpendicular to the first direction, as well as to move with the carriage along the first direction. For example, the carriage can move toward a cassette in a

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INDUSTRIAL <o APD cycler in a first direction to engage the caps in the solution lines on the caps on the cassette's pins. The cap separator can engage the caps (e.g., by moving in a direction transverse to the carriage's movement) and then move with the carriage as the carriage moves away from the cassette to remove the caps from the pins. The carriage can then pull the solution line connector ends from the caps into the cap separator, which can be retracted to allow the carriage to engage the now exposed solution line connector ends with the exposed cassette pins.

In one configuration, the cart may include a plurality of slots, each receiving a corresponding solution line. By placing the solution lines in corresponding slots, each line can be more easily identified individually, e.g., by reading a barcode or other identifier on the line, and controlling the system accordingly. The carriage can be mounted to a cycler housing door, and a carriage drive can move the carriage in the first direction. In one embodiment, the carriage drive can engage the carriage when the door is moved to a closed position and disengage from the carriage when the door is moved to an open position.

In one embodiment, the cap separator may include a plurality of fork-shaped elements arranged to engage with a corresponding cap in a solution line carried by the cart. The fork-shaped elements can hold the caps when they are

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INDUSTRIAL <o moved from the solution line and each of the solution line caps can by itself hold a spigot cap. In another embodiment, the cap separator may include a plurality of swing arms each associated with a fork-shaped element. Each of the swing arms may be arranged to move in order to engage a spigot cap, e.g., to help remove the spigot cap from the corresponding spigot. Each oscillating arm can be positioned to engage with a corresponding spigot cap only when the associated fork-shaped element engages with a cap on a solution line. Therefore, the cap separator may not engage or remove spigot caps from the cassette in locations where there is no corresponding solution line to connect with the spigot.

In another aspect of the invention, a method for connecting fluid lines in a medical infusion fluid handling system, such as an APD cycler, may involve locating solution lines and cassette spikes in an enclosed space away from human touch. Solution lines and/or spigots may have caps removed and the lines connected to spigots while in the enclosed space, thus providing the connection while minimizing potential contamination at the connection, e.g., by fingers carrying pathogens or other potentially harmful substances. For example, a method in conformity with this aspect of the invention includes providing a plurality of solution lines, each having a connector end and a cap, providing a cassette of

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INDUSTRIAL fluid handling having a plurality of spigots each covered by a spigot cap, enclosing the connector ends of the plurality of solution lines with caps covering the connector ends and the plurality of spigots with spigot caps covering the spigots in a space that prevents human contact with the caps or spigot cap, removing the connector end caps from a plurality of solution lines without removing the connector end caps from the space, removing the spigot caps from the spigots without removing the spigot caps or spigots from the space, engaging the caps with respective spigot caps, and smoothly connecting the plurality of connector ends to corresponding studs while keeping the connector ends and studs in space and protected from human contact.

In one configuration, solution line caps and spike caps can be hooked together before being removed from the lines or spikes, and then removed from both while still hooked. This technique can simplify the uncapping/capping process and allow for easier storage of the caps.

In another modality, the solution lines can be disconnected from the spikes, and the connector ends of the lines and spikes can be re-capped, e.g., after the treatment is completed.

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In another aspect of the invention, a dialysis machine can

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INDUSTRIAL <or include a fluid handling cassette having a plurality of spigots and a plurality of spigot caps covering a respective spigot, a plurality of solution lines each having a cap covering a respective line connector end and a cap separator arranged to remove one or more caps from a solution line connector end, and removing one or more spigot caps from a spigot in the cassette while one or more caps are secured to one of the corresponding spigot caps. As described above, the machine may be arranged to automatically and smoothly connect one connector end of a solution line to a corresponding spigot after the caps are removed.

In another aspect of the invention, a dialysis machine, such as an APD system, may include a cassette having a plurality of fluid pins and a plurality of pin caps covering a respective pin, a cart arranged to receive a plurality of solution lines each having a cap covering a connector end of the respective line, and a cap separator arranged to engage one or more caps covering a connector end of a line. The cart and cap separator can be configured to engage one or more caps or a connector end of a line while one or more caps are being flared with a corresponding spigot cap that covers a spigot on the cassette, and to remove the spigot cap from the spigot and the connector end cap from the solution line, and to connect the fluid to the spigot and the

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INDUSTRIAL <o end of solution line connector after caps are removed.

In another aspect of the invention, a dialysis machine may include a cap separator that is arranged to remove one or more caps on a connector end of a solution line, remove one or more spigot caps from a fluid handling cassette, and retain and reattach the caps to the solution lines and the spigot caps to the spigots on the cassette.

In another aspect of the invention, a fluid line connection system for a peritoneal dialysis system includes a fluid handling cassette having a generally flat body with at least one pump chamber formed as a depression in a first part of the body and a plurality of fluid flow paths, a plurality of dialysate solution line spikes located at a first end of the body, The solution line spigots being in fluid communication with at least one pump chamber by means of at least one flow path and arranged so that the spigots are generally coplanar with the generally flat body of the fluid handling cassette, and a carriage arranged to receive a plurality of solution lines, wherein each solution line has a connector end. The cart can be arranged to automatically connect the fluid to one connector end of a solution line with a corresponding spigot.

In one mode, the cart is arranged to move the lines.

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INDUSTRIAL <o of solution and respective caps along a first direction substantially parallel to the generally flat body of the fluid handling cassette. A carriage drive that moves the carriage only in the first direction may include a drive element and a pneumatic bladder or screw drive to move the drive element along the first direction. A cap separator may be provided which is arranged to remove one or more caps from a connector end of a solution line, and to remove one or more spigot caps from a spigot on the cassette while one or more caps are secured to a corresponding spigot cap. In one embodiment, the cap separator may be arranged to retain and reattach the caps to the solution lines and the spigot caps to the cassette spigots.

In another aspect of the invention, a peritoneal dialysis system may include a cycler device with components suitable for controlling the delivery of dialysate to a patient's peritoneal cavity. The cycler device may have a housing that encloses at least some of the components and has a heater bag receiving section. (The term “heater bag ” is used here to refer to any container suitable for heating the dialysate, such as a flexible or rigid container, whether made of polymer, metal, or other suitable material. A lid may be mounted to the housing and be removable between an open position in which a heater bag is placeable in the heater bag receiving section and a closed position in which the

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INDUSTRIAL <o lid covers the receiving section of the heater bag. This arrangement may allow for faster or more efficient heating of the dialysate in the heater bag, e.g., because the heat can be retained by the lid. Also, the lid can help prevent human contact with potentially hot surfaces.

In one modality, the dialysis system may include a fluid handling cassette with a heater bag port attached to a heater bag line, a patient port attached to a patient line, and at least one pump chamber for moving fluid in the patient line and the heater bag line. A heater bag may be attached to the heater bag line and disposed of for placement in the heater bag receiving section.

In another embodiment, the system may include an interface (such as a visual display with a touch screen component) that is movably mounted to the housing and is movable between a first position in which the interface is received in the heater bag receiving section, and a second position in which the interface is located outside the heater bag receiving section (e.g., a position in which a user can interact with the interface). Therefore, the interface can be hidden from view when the system is unloaded, thus protecting it. Additionally, storing the interface in the heater bag receiver section can make the system more compact, at least in its "as-stored" condition.

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INDUSTRIAL <o

In another aspect of the invention, a dialysis system includes a pneumatic pressure and/or vacuum supply suitable for controlling pneumatically operated components of the system, a pneumatically operated component that is fluidly connected to the pneumatic pressure and/or vacuum supply, and a control system that provides pneumatic pressure or vacuum to the pneumatically operated component and subsequently isolates the pneumatically operated component from the pneumatic pressure or vacuum supply for a substantial period before supplying pneumatic pressure or vacuum to the pneumatically operated component again. Such an arrangement may be useful for components that are actuated relatively infrequently, such as the occluder arrangement described herein. Small movements of some components can cause the component to emit noise that may be bothersome to the patient. By isolating the component from the pneumatic pressure/vacuum, slight movements caused by variations in supply pressure/vacuum, e.g., resulting from pressure/vacuum being drawn away by other components in the system, can be avoided. In one modality, the substantial period may be 5 minutes or more, 1 hour or more, 50% or more of a period required to supply or remove an adequate volume of dialysate for dialysis treatment with respect to the patient's peritoneal cavity, or other suitable periods.

In another aspect of the invention, a dialysis system includes a supply of pneumatic pressure and/or vacuum suitable for controlling

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INDUSTRIAL <o pneumatically operated components of the system, a pneumatically operated component that is fluidly connected to the pneumatic pressure and/or vacuum supply, and a control system that provides pneumatic pressure or vacuum to the pneumatically operated component and controls the pneumatic pressure or vacuum to reduce noise generated by the pneumatically operated component. For example, the pneumatically operated component may include at least one moving part (such as a pump diaphragm), and the control system may reduce the pneumatic pressure or vacuum supplied to the pneumatically operated component to decelerate the movement of the moving part as the moving part stops and/or changes direction (e.g., Pressure/vacuum can be controlled to slow the diaphragm's movement before it changes direction. Alternatively, pulse amplitude modulation control of a pressure/vacuum supply valve can be used, e.g., to reduce noise emitted by moving parts of the valve.

In another aspect of the invention, a dialysis system includes a pneumatic pressure and vacuum supply suitable for controlling pneumatically operated components of the system. A first pneumatically operated component can be fluidly connected to the pneumatic pressure and/or vacuum supply and has a first outlet line for releasing pneumatic pressure. A second pneumatically operated component can be fluidly connected to the pneumatic pressure and/or vacuum supply and

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INDUSTRIAL <o have a second vacuum line to release pneumatic vacuum. A space, such as that defined by an accumulator, manifold or soundproof chamber, can be seamlessly connected to both the first and second outlet lines. A control system can provide pneumatic pressure or vacuum to pneumatically operated components so that when the first and second components release pressure/vacuum during operation, the released pressure/vacuum can be received in the common space (e.g., a manifold). In some circumstances, the positively pressurized gas released by one component can be balanced by negative pressure released by other components, thus reducing the noise generated.

In another aspect of the invention, a peritoneal dialysis system may include a fluid handling cassette having a fluid-connected patient line leading from a patient's peritoneal cavity, and including at least one pump chamber for moving the dialysate solution in the patient line. A cycler device may be arranged to receive and interact with the fluid handling cassette and cause at least one pump chamber to move the dialysate solution into the patient line. The cycler may include a control system arranged to control at least one pump chamber to operate in a priming operation to force the dialysate solution into the patient line to remove any air in the patient line, and may be adapted to interface with two types of fluid handling cassettes that differ with respect to a patient line volume

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INDUSTRIAL <o connected to the cassette body. A first type of cassette may have a relatively low volume patient line (e.g., for pediatric applications), and a second type of cassette may have a relatively high volume patient line (e.g., for adult applications), and the control system can detect whether a cassette received by the cycler is a first type or a second type and adjust the operation of the cycler accordingly.

In one mode, the control system can detect whether a cassette received by the cycler is a first-type or second-type by determining the patient line volume during priming, and adjust the amount of fluid moved through the cassette during system operation. In another mode, indicators, such as a barcode, on the cassette can be detected by the cycler and cause it to adjust pumping operation based on the cassette type.

In another aspect of the invention, a dialysis machine includes a fluid handling cassette having a plurality of pins and at least one pump chamber for moving fluid into the pins, a plurality of solution lines each hooked up to a respective pin in the cassette, and a control system that reads cues on each of the solution lines to determine a type for each of the solution lines. The control system can adjust a pumping operation or other cycler operation based on the identity of one or more of the solution lines. For example, a solution line can be identified as

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INDUSTRIAL <or being an effluent sampling line and the pumping operation can be adjusted to direct used dialysate from a patient to the effluent sampling line during a draining cycle.

In another aspect of the invention, a method for automatically recovering from a tilted condition in a dialysis system may include (A) detecting a tilt angle of at least a portion of a dialysis system, the portion of the dialysis system including machinery for performing dialysis therapy, (B) determining that a tilted condition exists in which the tilt angle exceeds a predetermined threshold, (C) in response to (B), pausing dialysis therapy, (D) monitor the tilt angle while dialysis therapy is paused, (E) determine that the tilted condition no longer exists, and (F) in response to (E), automatically resume dialysis therapy.

In another aspect of the invention, a patient data interface for a dialysis system includes a device port comprising a depression in a chassis of at least a portion of the dialysis system and a first connector disposed within the depression. A patient data storage device may include a housing and a second connector coupled to the housing, wherein the second connector is adapted to be selectively coupled to the first connector. The recess may have a first shape and the housing may have a second shape corresponding to the first shape, such that when the first and second connectors are coupled, the housing of the

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INDUSTRIAL <The patient data storage device is received at least partially within the depression. The first and second forms may be irregular and the patient data storage device may have a verification code that is readable by the dialysis system to verify that the patient data storage device is of an expected type and/or origin.

In another aspect of the invention, a method for providing peritoneal dialysis includes supplying or withdrawing dialysate with respect to the patient's peritoneal cavity at a first pressure, and adjusting a pressure at which the dialysate is supplied or withdrawn to minimize the sensation of dialysate movement to the patient. In one mode, the pressure can be adjusted during a single filling or emptying cycle of peritoneal dialysis therapy, and/or within different filling or emptying cycles of peritoneal dialysis therapy. For example, when dialysate is removed from a patient, the pressure at which the dialysate is removed can be reduced when the amount of dialysate remaining in the peritoneal cavity falls below a threshold volume. Reducing the pressure (negative pressure or vacuum) near the end of a drainage cycle can lessen the sensation the patient may have of dialysate removal.

In another aspect of the invention, a method for providing peritoneal dialysis includes providing a first solution to the patient's peritoneal cavity using a reusable cycler device during a first peritoneal dialysis treatment, and providing a second solution to the cavity

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INDUSTRIAL <or peritoneal of the patient using the reusable cycler device during a second peritoneal dialysis treatment immediately after the first treatment, where the second solution has a different chemical composition compared to the first solution. The different solutions can be created by mixing liquid material from two or more solution containers that are connected to the cycler (e.g., by means of a cassette mounted on the cycler). Solution containers can be automatically identified by the cycler, e.g., by reading a barcode, RFID tag, or other indicators.

In another aspect of the invention, a medical infusion system includes a housing that encloses at least some of the system components, and a control surface fixed to the housing and constructed and arranged to control the operation of a fluid handling cassette that can be removably mounted to the housing. The control surface may have a plurality of movable portions arranged to control the pumping and valve operations of the cassette, and at least one of the movable portions may have an associated vacuum port arranged to remove fluid from a region near the movable portion.

In one embodiment, the control surface includes a sheet of elastic polymeric material, and each of the movable portions may have an associated vacuum port. In another embodiment, the cassette includes a membrane that is positionable adjacent to the control surface, and the vacuum port is arranged to remove fluid from a space between the membrane and the membrane.

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INDUSTRIAL <o and the control surface. A liquid sensor may be arranged to detect liquid being drawn into the vacuum port, e.g., in the event that the membrane ruptures, allowing liquid to leak from the cassette.

In another aspect of the invention, a volume of fluid moved by a pump, such as a pump in an APD system, can be determined based on pressure measurement and a certain known chamber and/or line volumes, but without direct measurement of the fluid, such as by flow meter, weight, etc. In one embodiment, the volume of a pump chamber having a movable element that varies the volume of the pump chamber can be determined by measuring the pressure in the pump chamber and a reference chamber while they are isolated from each other, and after the two chambers are fluidly connected so that the pressures in the chambers can be equalized. In one modality, the equalization of pressures can be assumed to occur in an adiabatic manner, e.g., a mathematical model of the system that is based on an adiabatic pressure equalization process can be used to determine the volume of the pump chamber. In another embodiment, the pressures measured after the chambers are fluidly connected can be measured at a time before the equalization has ended, and therefore the pressures for the pump and reference chambers measured after the chambers are fluidly connected may be unequal, but can be used to determine the pump chamber volume. This approach can reduce the time between measuring the initial and final pressures, thus reducing a

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INDUSTRIAL <o time during which heat transfer can take place and reducing the error that may be introduced given the adiabatic model used to determine the volume of the pump chamber.

In one aspect of the invention, a method for determining a volume of fluid moved by a pump includes measuring a first pressure for a pump control chamber when the pump control chamber is isolated from a reference chamber. The pump control chamber may have a volume that varies at least in part based on the movement of a portion of the pump, such as a pump membrane or diaphragm. A second pressure can be measured for the reference chamber when the reference chamber is isolated from the pump control chamber. The reference chamber can have a known volume. A third pressure associated with the pump control chamber after fluid connection from the reference chamber and the pump control chamber can be measured, but the measurement may occur before substantial equalization of pressures between the pump control and reference chambers has occurred. Similarly, a fourth pressure associated with the reference chamber can be measured after fluid connection between the reference chamber and the pump control chamber, but before substantial pressure equalization has occurred between the pump control and reference chambers. A volume for the pump control chamber can then be determined based on the first, second, third, and fourth pressure measurements.

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INDUSTRIAL <o

In one modality, the third and fourth pressures are measured at approximately the same time and the third and fourth pressures are substantially unequal to each other. For example, equalization of pressures in the pump control and reference chambers can occur after an equalization period once the pump control and reference chambers are fluidly connected, but the third and fourth pressures can be measured at a time after the pump control and reference chambers are fluidly connected that is approximately 10% to 50% of the equalization period. Therefore, the third and fourth pressures can be measured well before (in terms of time) the pressures in the chambers have fully equalized. Alternatively, the third and fourth pressures can be measured at a time when the pressures in the chambers have reached approximately 50–70% equalization; for example, the pressures in the chambers have changed from an initial value that is within approximately 50–70% of an equalized pressure value. Therefore, the period between measuring the first and second pressures and measuring the third and fourth pressures can be minimized.

In another embodiment, a model for determining the pump control chamber volume may incorporate an assumption that an adiabatic system exists from a point in time when the first and second pressures are measured for the isolated pump control chamber and reference chamber to a point in time when the third and

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INDUSTRIAL <o fourth pressures are measured.

To determine the volume of fluid moved by the pump, the first, second, third, and fourth pressure measurement steps, along with the final determination step, can be performed for two different positions of a diaphragm pump to determine two different volumes for the pump's control chamber. The difference between these two volumes represents the volume of fluid delivered by the pump.

As mentioned before, this aspect of the invention can be used in any suitable system, such as a system in which the pump is part of a disposable cassette and the pump control chamber is part of a dialysis machine used in a dialysis procedure.

In one mode, the first and/or second pressure can be selected from a plurality of pressure measurements as coinciding with a point in time at which a pressure in the pump control chamber or reference chamber (as appropriate) first begins to change from a previously stable value. For example, the point in time can be identified based on a determination of when a best-fit line for a plurality of consecutive sets of measured pressures first deviates from a constant slope. This approach can help identify initial pressures for the pump control and reference chambers that are as late in time as possible, while reducing error in determining the pump volume.

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INDUSTRIAL <o

In another modality, a technique can be used to identify an optimal point in time at which the third and fourth pressures are measured. For example, a plurality of pressure values ​​for the pump control chamber can be measured after the pump control and reference chambers are fluidly connected, and a plurality of change in volume values ​​can be determined for the pump control chamber based on the plurality of pressure values ​​for the pump control chamber. Each of the plurality of changes in volume values ​​can correspond to a single point in time and a measured pressure value for the pump chamber. In this case, the change in volume values ​​is due to the movement of an imaginary piston located in the valve or other component that initially isolates the pump's control and reference chambers, but which moves when the valve or other component opens. Therefore, the pump chamber does not actually change in size or volume, but rather the change in volume is an imaginary condition due to the pressures in the pump chamber and reference chamber being initially different from each other. Similarly, a plurality of pressure values ​​for the reference chamber can be measured after the pump control and reference chambers are fluidly connected, and a plurality of changes in volume values ​​for the reference chamber can be determined based on the plurality of pressure values ​​for the reference chamber. Each of the plurality of changes in volume values ​​can correspond to a unique point in the

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INDUSTRIAL <o time and a measured pressure value for the reference chamber, and just as in the change in volume values ​​for the pump chamber, are a result of the movement of an imaginary piston. A plurality of difference values ​​between change in volume values ​​for the pump control chamber and for the reference chamber can be determined, with each difference value being determined for changes in volume values ​​for the pump control chamber and changes in volume values ​​for the corresponding reference chamber, i.e. The pairs of changes in volume values ​​for which a difference value is determined correspond to the same or substantially the same point in time. The difference values ​​can be analyzed, and a minimum difference value (or a difference value below a desired threshold) can indicate a point in time for which the third and fourth pressures should be measured. Therefore, the third and fourth pressure values ​​can be identified as being equal to the pump control chamber pressure value and the reference chamber pressure value, respectively, which corresponds to a difference value that is a minimum or below a threshold.

In another embodiment, the measured pressures are gas pressures within the pump control chamber and the reference chamber; pressure equalization within the pump control chamber and reference chamber is assumed to occur adiabatically; pressure equalization between the pump control chamber and reference chamber is

MX/a/2021/007240

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INDUSTRIAL <o assumes that it includes a change in the volume of a gas in the pump control chamber and reference chamber in equal but opposite directions, and the volume of gas in the reference chamber at the time of the fourth pressure measurement is calculated from the known volume of the reference chamber, and the second and fourth pressures. The change in gas volume in the reference chamber can be assumed to be the difference between the known volume of the reference chamber and the calculated value of the gas volume in the reference chamber at the time of the fourth pressure measurement. Also, the change in gas volume in the pump control chamber can be assumed to be the difference between the initial volume of the pump control chamber and the volume of gas in the pump control chamber at the time of the third pressure measurement, where the change in gas volume in the pump control chamber is equal to but opposite to the change in gas volume in the reference chamber.

In another aspect of the invention, a method for determining a volume of fluid moved by a pump includes providing a fluid pump apparatus having a pump chamber separated from a pump control chamber by a movable diaphragm, and a reference chamber that is fluidly connectable to the pump control chamber, setting a first pressure in the pump control chamber to cause the diaphragm to move and thereby move the fluid in the pump chamber, Isolate the reference chamber from the pump control chamber and establish a second pressure in the reference chamber that is different

MX/a/2021/007240

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INDUSTRIAL <o of a pressure in the pump control chamber, fluid connection of the reference chamber and the pump control chamber to initiate equalization of pressures in the pump control chamber and the reference chamber, and determine a volume for the pump control chamber based on the first and second pressures, and an assumption that the pressures in the pump control and reference chambers initiate equalization in an adiabatic manner.

In one configuration, third and fourth pressures for the pump control and reference chambers, respectively, can be measured after fluid connection between the reference and pump control chambers, and these third and fourth pressures can be used to determine the volume for the pump control chamber. These third and fourth pressures can be substantially different from each other. Similar to the above, the adjustment, isolation, fluid connection, and determination steps can be repeated, and a difference between the two determined volumes for the pump control chamber can be determined, where the difference represents a volume of fluid supplied by the pump.

In another configuration, the pump is part of a disposable cassette and the pump's control chamber is part of a dialysis machine used in a dialysis procedure.

In another aspect of the invention, a medical infusion system includes a pump control chamber and an associated control surface.

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INDUSTRIAL <o with the pump control chamber such that at least a portion of the control surface is movable in response to a pressure change in the pump control chamber, a fluid handling cassette having at least one pump chamber located adjacent to the control surface and arranged so that the fluid in at least one pump chamber moves in response to the movement of the portion of the control surface, a reference chamber that is fluidly connectable to the pump control chamber, and a control system arranged to adjust a pressure in the pump control chamber and thereby control fluid movement in the pump chamber of the fluid handling cassette. The control system can be arranged to measure a first pressure for the pump control chamber when the pump control chamber is isolated from the reference chamber, measure a second pressure for the reference chamber when the reference chamber is isolated from the pump control chamber, and seamlessly connect the pump control chamber and the reference chamber. Measure the third and fourth pressures associated with the pump control chamber and the reference chamber, respectively, after connecting the fluid to the reference chamber and the pump control chamber, and determine a volume for the pump control chamber based on the first, second, third and fourth measured pressures and a mathematical model that defines pressure equalization in the pump control and reference chambers as occurs adiabatically when the pump control and reference chambers

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INDUSTRIAL <o are fluidly connected.

In one mode, the third and fourth pressures are substantially unequal to each other, e.g., the third and fourth pressures can be measured before the substantial equalization of pressures in the pump control and reference chambers.

In another aspect of the invention, a method for determining a volume of fluid moved by a pump includes measuring a first pressure for a pump control chamber when the pump control chamber is isolated from a reference chamber, the pump control chamber having a volume that varies at least in part based on the movement of a portion of the pump, Measure a second pressure for the reference chamber when the reference chamber is isolated from the pump control chamber, measure a third pressure associated with the pump control chamber and the reference chamber after fluid connection of the reference chamber and the pump control chamber, and determine a volume for the pump control chamber based on the first, second, and third measured pressures.

In one embodiment, the third pressure can be measured after complete equalization of pressures in the pump control and reference chambers is achieved. In another embodiment, a model used to determine the pump chamber volume can adopt an adiabatic pressure equalization system between the pump chamber and the reference chamber.

MX/a/2021/007240 reference.

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INDUSTRIAL <o

In one aspect of the invention, a method for determining the presence of air in a pump chamber includes measuring a pressure for a pump control chamber when the pump control chamber is isolated from a reference chamber, the pump control chamber having a known volume and being separated from a pump chamber, which is at least partially filled with liquid, by a membrane, Measure a pressure for the reference chamber when the reference chamber is isolated from the pump control chamber, the reference chamber having a known volume, measure a pressure after fluid connection of the reference chamber and the pump control chamber and before a time when the pressure in the chambers has equalized, and determine a presence or absence of an air bubble in the pump chamber based on the measured pressures and known volumes.

In one embodiment, a model used to determine the presence or absence of an air bubble adopts a point-in-time adiabatic system where pressures are measured for the pump control chamber and the isolated reference chamber up to a point in time after the chambers are fluidly connected. In another embodiment, the pressure for the pump control chamber is measured with the diaphragm brought against a wall of the pump control chamber.

In another aspect of the invention, an automated peritoneal dialysis system includes a reusable cycler that is constructed and arranged for coupling to a disposable fluid handling cassette.

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INDUSTRIAL <o containing at least one pumping chamber. The disposable fluid handling cassette can be configured to be connected in fluid communication with the peritoneum of a patient by means of a first squeezable tube and with a second resource and/or destination (such as a solution container line) by means of a second squeezable tube. An occluder can be configured and positioned within the cycler to selectively occlude the first squeezable tube while not occluding the second squeezable tube. In one configuration, the occluder can occlude a plurality of squeezable tubes, such as a patient line, a drain line, and/or a heater bag line. The cassette may have a generally flat body with at least one pump chamber formed as a depression on a first side of the body and a plurality of flow paths for fluid, a patient line port located at a first end of the body arranged for connection to the first squeezable tube, and a solution line port located at a second end of the body opposite the first end, and arranged for connection to the second squeezable tube. The occluder can be configured and located within the cycler to selectively occlude the first tube and a third squeezable tube (e.g., for drainage) while not occluding the second squeezable tube.

In another embodiment, the occluder includes first and second opposing occluding members pivotally connected to each other, a tube contact member connected to, or comprising at least a portion of, at least one of the first and second occluding members,

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INDUSTRIAL <o and a force actuator constructed and located to apply a force to at least one of the first and second occlusion members. The application of force by the force actuator may cause the member in contact with the tube to move between a tube occlusion position and an open position. The occluder may include a release member configured and located to allow an operator to manually move the tube contact member from the tube occlusion position to the open position even without force applied to the occlusion member by the force actuator. The force actuator can apply sufficient force to bend both the first and second occlusion members, so that under the application of force by the force actuator to bend the first and second occlusion members, the member in contact with the tube can move between a tube occlusion position and an open position. The occluding members can be spring plates pivotally connected together at opposite first and second ends, and the tube contact member can be a clamp head connected to the spring plates at the first ends, while the second ends of the spring plates can be fixed directly or indirectly to a housing to which the occluder is connected. In one embodiment, the force actuator comprises an inflatable bladder located between the first and second occluding members. The force actuator can increase the distance between the first and second occluding members in a region where the first and second occluding members are in opposition, thereby moving the member.

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<img file="MX428429B_D0001.tif" />

IMPI

MEXICAN INSTITUTE OF PROPERTY IO

INDUSTRIAL &lt;or contact with the tube between a tube occlusion position and an open position. In one embodiment, the force actuator can bend one or both of the occlusion members to move the tube contact member from a tube occlusion position to an open position.

Several aspects of the invention have been described above and are described below with reference to illustrative embodiments. It is understood that the various aspects of the invention can be used alone and/or in any suitable combination with other aspects of the invention. For example, the pump volume characteristics described here can be used with a liquid handling cassette that has the specific characteristics described, or with any other suitable pump configuration.

MX/a/2021/007240

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the invention are described below with reference to illustrative embodiments shown, at least in part, in the following figures, in which similar numbers refer to similar elements, and in which:

Figure 1 shows a schematic view of an automated peritoneal dialysis (APD) system incorporating one or more aspects of the invention;

Figure 2 is a schematic view of an illustrative assembly

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INDUSTRIAL &lt;or for use with the APD system in Figure 1;

Figure 3 is an exploded perspective view of a cassette in a first mode;

Figure 4 is a cross-sectional view of the cassette along line 4-4 in Figure 3;

Figure 5 is a perspective view of a vacuum mold that can be used to form a membrane having preformed pump chamber portions in an illustrative manner;

Figure 6 shows a front view of the cassette body of Figure 3;

Figure 7 is a front view of a cassette body including two different separator arrangements in an illustrative manner;

Figure 8 is a rear perspective view of the cassette body of Figure 3;

Figure 9 is a rear view of the cassette body of Figure 3;

Figure 10 is a perspective view of the APD system of Figure 1 with the cycler door in an open position;

Figure 11 is a perspective view of the inner side of the cycler door shown in Figure 10;

Figure 12 is a right front perspective view of a carriage drive and lid separator assembly in a first

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INDUSTRIAL &lt;or modality;

Figure 13 is a left front perspective view of the carriage drive and lid separator assembly of Figure 12;

Figure 14 is a partial rear view of the carriage drive assembly of Figure 12;

Figure 15 is a rear perspective view of a carriage drive assembly in a second illustrative embodiment;

Figure 16 is a left rear perspective view of the carriage drive and lid separator assembly of Figure 15;

Figure 17 is a left front perspective view of a lid separator element in an illustrative manner;

Figure 18 is a right front perspective view of the lid separator element of Figure 17;

Figure 19 is a front view of the lid separator element of Figure 17;

Figure 20 is a cross-sectional view along line 20-20 in Figure 19;

Figure 21 is a cross-sectional view along line 21-21 in Figure 19;

Figure 22 is a cross-sectional view along line 22-22 in Figure 19;

Figure 23 is an exploded close-up view of the connector end of a solution line in an illustrative manner;

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INDUSTRIAL &lt;o

Figure 24 is a schematic view of a cassette and solution lines that are loaded into the cycler of Figure 10;

Figure 25 is a schematic view of the cassette and solution lines after being placed in their respective locations on the cycler door of Figure 10;

Figure 26 is a schematic view of the cassette and solution lines after the cycler door is closed;

Figure 27 is a schematic view of the solution lines that are hooked with dowel caps;

Figure 28 is a schematic view of the cap separator that engages with spike caps and solution caps;

Figure 29 is a schematic view of the solution lines with joined caps and stud caps after the cassette has moved away;

Figure 30 is a schematic view of the solution lines after the away movement of the solution line caps and spike caps;

Figure 31 is a schematic view of the cap separator that retracts with solution line caps and spike caps;

Figure 32 is a schematic view of the solution lines being hooked onto the cassette pins;

Figure 33 is a cross-sectional view of a cassette with five stages of a solution line connection operation shown

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INDUSTRIAL &lt;o with respect to corresponding cassette spikes;

Figure 34 shows a rear view of a cassette in another illustrative form that includes different arrangements for a rear side of the cassette adjacent to the pump chambers;

Figure 35 shows an extreme view of a cassette pin in an illustrative manner;

Figure 36 shows a front view of a cycler control surface for interaction with a cassette in the mode of Figure 10;

Figure 37 shows an exploded view of an assembly for the interface of Figure 36;

Figure 38 shows an exploded perspective view of an occluder in an illustrative configuration;

Figure 39 shows a partially exploded perspective view of the occluder in Figure 38;

Figure 40 shows a top view of the figure occluder with the bladder in a deflated state;

Figure 41 shows a top view of the figure occluder with the bladder in an inflated state;

Figure 42 is a schematic view of a cassette pump chamber and associated control components and inflow/outflow paths in an illustrative mode;

Figure 43 is a graph of illustrative pressure values

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INDUSTRIAL &lt;o for the control chamber and the reference chamber from a point in time before opening valve X2 until some time after valve X2 is opened for the mode of figure 42;

Figure 44 is a perspective view of an interior section of the cycler of Figure 10 with the upper portion of the housing removed;

Figure 45 is a schematic block diagram illustrating an illustrative implementation of the control system for an APD system;

Figure 46 is a schematic block diagram of software subsystems illustrative of a user interface computer and the automation computer for the control system of Figure 45;

Figure 47 shows an information flow between various subsystems and processes of the APD system in an illustrative manner;

Figure 48 illustrates an operation of the therapy subsystem of Figure 46;

Figure 49 shows a sequence diagram illustrating illustrative interactions of therapy module processes during filling and dialysis portions of therapy;

Figures 50-55 show illustrative screen views related to alerts and alarms that can be displayed on a touch screen user interface for the APD system;

Figure 56 illustrates component states and operations for error condition detection and recovery in an illustrative mode;

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INDUSTRIAL &lt;o

Figure 57 shows illustrative modules of a III view subsystem for the APD system;

Figures 58-64 illustrate user interface screens for providing user information and receiving user input in illustrative modalities relating to system readiness, therapy status, display values, remote assistance, and parameter values; and

Figure 65 shows an illustrative patient data key and associated port for transferring patient data to and from the APD system.

DETAILED DESCRIPTION OF THE INVENTION

Although aspects of the invention are described in relation to a peritoneal dialysis system, certain aspects of the invention may be used in other medical applications, including infusion systems such as intravenous infusion systems or extracorporeal blood flow systems, and irrigation and/or fluid exchange systems for the stomach, intestinal tract, urinary bladder, pleural space, or other body cavity or organ. Therefore, the aspects of the invention are not limited to use in peritoneal dialysis in particular, or dialysis in general.

APD System

Figure 1 shows a peritoneal dialysis system

MX/a/2021/007240

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W ~ OF THE PROPERTY IO

INDUSTRIAL &lt;or automated (APD) 10 that may incorporate one or more aspects of the invention. As shown in Figure 1, for example, the system 10 in this illustrative embodiment includes a dialysate delivery unit 12 (which, in certain embodiments, may be a disposable unit), a cycler 14 that interacts with the delivery unit 12 to pump fluid supplied by a solution container 20 (e.g., a bag), and a control system 16 (e.g., which includes a programmed computer or other data processor, computer memory, an interface to provide information to and receive input from a user or other device, one or more sensors, actuators, relays, pneumatic pumps, tanks, a powder supply, and/or other suitable components - only some buttons for receiving input from the user control are shown in Figure 1, but additional details regarding the control system components are provided later) that governs the process to perform an APD procedure. In this illustrative embodiment, the cycler 14 and the control system 16 are associated with one housing 82, but they may be associated with two or more housings and/or may be separate from each other. The cycler 14 may have a compact footprint, suitable for operation on a table or other relatively small surface typically found in the home. The cycler 14 can be lightweight and portable, e.g., carried by hand using handles on opposite sides of the housing 82.

Team 12 in this modality is intended to be a single-use disposable item, but it may actually have one or more components

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INDUSTRIAL &lt;or reusable, or may be fully reusable. The user associates the device 12 with the cycler 14 before starting each APD therapy session, e.g., by mounting a cassette 24 inside a front door 141 of the cycler 14, which interacts with the cassette 24 to pump and control the fluid flow in the various lines of the device 12. For example, the dialysate may be pumped both to and from the patient to perform APD. After therapy, the user can remove all or part of the components of equipment 12 from cycler 14.

As is known in the art, prior to use, the user can connect a patient line 34 from the device 12 to their internal peritoneal catheter (not shown) at a connection 36. In one modality, the cycler 14 can be configured to operate with one or more different types of cassettes 24, such as those having patient lines of different sizes 34. For example, the cycler 14 can be arranged to operate with a first type of cassette with a patient line 34 sized for use with an adult patient, and a second type of cassette with a patient line 34 sized for use in young children or pediatric patients. The pediatric patient line 34 may be shorter and have a smaller internal diameter than the adult line to minimize line volume, allowing for more controlled dialysate delivery and helping to avoid returning to a relatively large volume of dialysate used for the pediatric patient when the set 12 is used for consecutive drain and fill cycles. A heater bag 22, which is connected to the

MX/a/2021/007240

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INDUSTRIAL &lt;o cassette 24 by a line 26, can be placed in a receiving portion of heater container (in this case, a tray) 142 of the cycler 14. The cycler 14 can pump fresh dialysate (by means of the cassette 24) to the heater bag 22 so that the dialysate can be heated by the heater tray 142, e.g., by electrical resistance heating elements associated with the tray 142 to a temperature of approximately 37 degrees C. The heated dialysate can be supplied from the heater bag 22 to the patient by means of the cassette 24 and the patient line 34. In an alternative mode, the dialysate can be heated on its way to the patient as it enters, or after it leaves, the cassette 24 by passing the dialysate through the tube in contact with the heater tray 142, or through an in-line fluid heater (which can be supplied in the cassette 24). The used dialysate can be pumped from the patient through the patient line 34 to the cassette 24 and into a drain line 28, which may include one or more clamps to control the flow through one or more branches of the drain line 28. In this illustrative configuration, the drain line 28 may include a connector 39 for connecting the drain line 28 to a dedicated drain receptacle, and an effluent sampler 282 for taking a sample of used dialysate for testing or other analysis. The user may also mount the lines 30 from one or more containers 20 inside the door 141. The lines 30 may also be connected to a continuous or real-time dialysate preparation system. (Lines 26, 28, 30, 34 may include a flexible tube and/or connectors)

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INDUSTRIAL (or suitable and other components (such as contraction valves, etc.) as desired.) Containers 20 may hold sterile peritoneal dialysis solution for infusion, or other materials (e.g., materials used by the cycler 14 to formulate dialysate by mixing with water, or by mixing different types of dialysate solutions). Lines 30 may be connected to spigots 160 of the cassette 24, which are shown in Figure 1 covered by removable caps. In one aspect of the invention described in more detail below, the cycler 14 can automatically remove caps from one or more spikes 160 of the cassette 24 and connect lines 30 from solution containers 20 to respective spikes 160. This feature can help reduce the possibility of infection or contamination by reducing the likelihood of contact of non-sterile items with the spikes 160.

With several connections made, the control system 16 can guide the cycler 14 through a series of fill, residence, and/or drain cycles typical of an APD procedure. For example, during a fill phase, the cycler 14 can pump dialysate (via cassette 24) from one or more containers 20 (or another dialysate supply source) into the heater bag 22 for heating. Subsequently, cycler 14 can infuse heated dialysate from heater bag 22 through cassette 24 and into the patient's peritoneal cavity via patient line 34. After a residence phase, cycler 14 can initiate a drainage phase, during which cycler 14 pumps spent dialysate from the patient via line 34 (again

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W ~ OF THE PROPERTY IO

INDUSTRIAL (or by means of cassette 24), and discharges spent dialysis solution into a nearby drain (not shown) via drain line 28.

The cycler 14 does not necessarily require that the solution containers 20 and/or heater bag 22 be located at a prescribed head height above the cycler 14, e.g., because the cycler 14 is not necessarily a gravity flow system. Rather, cycler 14 can emulate gravity flow, or otherwise adequately control the flow of dialysate solution, even with the source solution containers 20 above, below, or at the same height as cycler 14, with the patient above or below the cycler, etc. For example, the cycler 14 can simulate a fixed head height during a given procedure, or the cycler 14 can change the effective head height to either increase or decrease the pressure applied to the dialysate during a procedure. The cycler 14 can also adjust the dialysate flow rate. In one aspect of the invention, the cycler 14 can adjust the pressure and/or flow rate of the dialysate when it is delivered to or withdrawn from the patient to reduce the patient's sensation of the filling or draining operation. This adjustment can occur during a single filling and/or draining cycle, or it can be adjusted across multiple filling and/or draining cycles. In one mode, the cycler 14 can reduce the pressure used to extract spent dialysate from the patient near the end of a drainage procedure. Because the cycler 14 can establish an artificial head height, it can have the flexibility to interact with and adapt to the patient's physiology.

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MEXICAN INSTITUTE

W ~ OF THE PROPERTY IO

INDUSTRIAL &lt;o particular or changes in the relative elevation of the patient.

Cassette

In one aspect of the invention, a 24-cassette may include patient and drain lines that are separately occludeable with respect to solution delivery lines. That is, critical safe flow from the patient line can be controlled, e.g., by squeezing the lines to stop the flow, without the need to occlude the flow through one or more solution delivery lines. This feature allows for a simplified occlusion device, as occlusion only needs to be performed on two lines, unlike occluding other lines that have little or no effect on patient safety. For example, in a situation where a patient or drain connection is disconnected, the patient and drain lines can be occluded. However, the supply solution lines and/or heater bag may remain open for flow, allowing the cycler 14 to prepare for an upcoming dialysis cycle; e.g., separate occlusion of patient and drain lines may help ensure patient safety while allowing the cycler 14 to continue pumping dialysate from one or more containers 20 to the heater bag 22 or to other solution containers 20.

In another aspect of the invention, the cassette may have patient, drain, and heater bag lines on one side or portion of the cassette and one or more solution delivery lines on another side or portion of the cassette.

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MEXICAN INSTITUTE

W ~ OF THE PROPERTY IO

INDUSTRIAL &lt;o cassette, e.g., one opposite side of the cassette. This arrangement may allow separate occlusion of patient, drain, or heater bag lines with respect to a solution line as described above. Physical separation of the lines attached to the cassette by type or function allows for more efficient interaction control with lines of a certain type or function. For example, this arrangement can allow for a simplified occluder design because less force is required to occlude one, two, or three of these lines than all the lines leading away from the cassette. Alternatively, this arrangement can allow for more efficient automated connections of solution supply lines to the cassette, as described in more detail later. That is, with solution supply lines and their respective connections located apart from the patient, drain and/or heater bag lines, an automated uncapping and connecting device can remove caps from the spikes on the cassette as well as caps on solution supply lines, and connect the lines to the respective spikes without interference from the patient, drain or heater bag lines.

Figure 2 shows an illustrative embodiment of a 24-pin cassette incorporating aspects of the invention described above. In this configuration, the cassette 24 has a generally flat body, and the heater bag line 26, drain line 28, and patient line 34 are connected to respective ports on the left end of the cassette body, while the right end of the cassette body may include five pins 160 to which the lines can be connected.

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o solution supply 30. In the arrangement shown in figure 2, each of the spigots 160 is covered by a spigot cap 63, which can be removed, exposing the respective spigot and allowing connection to a respective line 30. As described above, the 30 lines can be attached to one or more solution containers or other material sources, e.g., for use in dialysis and/or dialysate formulation, or connected to one or more collection bags for sampling purposes or for peritoneal equilibration testing (PET testing).

Figures 3 and 4 show exploded views (perspective and top views, respectively) of the cassette 24 in this illustrative configuration. The cassette 24 is formed as a relatively thin, flat member that is generally flat in shape; for example, it may include components that are molded, extruded, or otherwise formed from a suitable plastic. In this configuration, the cassette 24 includes a base member 18 that functions as a frame or structural member for the cassette 24 as well as forming, at least in part, various flow channels, ports, valve portions, etc. The base member 18 can be molded or otherwise formed from a suitable plastic or other material, such as polymethyl methacrylate acrylic (PMMA) or a cyclic olefin/ultra-low-density polyethylene (COC/ULDPE) copolymer, and can be relatively rigid. In one modality, the COC-to-ULDPE ratio can be approximately 85%/15%. Figure 3 also shows the ports for the heater bag (port 150), drain (port 152), and patient.

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INDUSTRIAL &lt;o (port 154) which are formed in base member 18. Each of these ports may be arranged in any suitable manner, such as, for example, a center tube 156 extending from an outer ring or skirt 158, or a center tube alone. The flexible tubing for each of the heater bag, drain, and patient lines 26, 28, 34 may be connected to the center tube 156 and hooked by the outer ring 158, if present.

Both sides of the base member 18 can be covered, at least in part, by a membrane 15 and 16, e.g., a flexible polymer film made of, for example, polyvinyl chloride (PVC), which is cast, extruded, or otherwise formed. Alternatively, the sheet can be formed as a laminar unit of two or more layers of polycyclohexylene dimethylene cyclohexanedicarboxylate (PCCE) and/or LILDPE, held together, for example, by a coextrudable adhesive (CXA). In some embodiments, the membrane thickness may be in the range of approximately 0.00508 to 0.0508 cm. In a preferred embodiment, the thickness of a PVC-based membrane may be in the range of approximately 0.030 to 0.040 cm, and very preferably approximately 0.014 cm. In another preferred embodiment, such as, for example, for laminated sheets, the thickness of the laminate unit may be in the range of approximately 0.015 to 0.025 cm thick, and very preferably approximately 0.020 cm thick.

Both membranes 15 and 16 can function not only to close off or otherwise form part of the flow paths of cassette 24,

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INDUSTRIAL &lt;or they can also be moved or otherwise manipulated to open/close valve ports and/or to function as part of a diaphragm, septum or pump wall that moves fluid in cassette 24. For example, membranes 15 and 16 can be located in base member 18 and sealed (e.g., by heat, adhesive, ultrasonic welding or other means) to a flange around the periphery of base member 18 to prevent fluid from leaking out of cassette 24. The membrane 15 can also be attached to other internal walls of the base member 18, e.g., those forming several channels, or can be pressed into sealing contact with the walls and other features of the base member 18 when the cassette 24 is properly mounted on the cycler 14. Therefore, both of the membranes 15 and 16 can be sealed to a peripheral flange of the base member 18, e.g., to help prevent fluid leakage from the cassette 24 when it is removed from the cycler 14 after use, but are arranged to lie, without being fixed, over other portions of the base member 18. Once placed in the cycler 14, the cassette 24 can be crushed between opposing packings or other members so that the membranes 15 and 16 are pressed into sealing contact with the base member 18 in regions within the periphery, thereby properly sealing the channels, valve ports, etc., from each other.

Other arrangements for membranes 15 and 16 are possible. For example, membrane 16 can be formed from a rigid sheet of material that is bonded or otherwise made integral with body 18.

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INDUSTRIAL &lt;or therefore, the membrane 16 need not be, or include, a flexible member. Similarly, the membrane 15 need not be flexible over its entire surface, but may rather include one or more flexible portions to allow operation of the pump and/or valve, and one or more rigid portions, e.g., to close off flow paths of the cassette 24. It is also possible that cassette 24 may not include membrane 16 or membrane 15, e.g., where cycler 14 includes a suitable member for sealing cassette paths, control valve and pump function, etc.

According to another aspect of the invention, the membrane 15 may include a pump chamber portion 151 (pump membrane) that is formed to have a configuration that closely conforms to the configuration of a corresponding pump chamber depression 181 at the base 18. For example, the membrane 15 can generally be formed as a flat member with thermoformed (or otherwise formed) dome-like configurations 151 that conform to the pump chamber depressions of the base member 18. The dome-like configuration of the preformed pump chamber portions 151 can be constructed, for example, by heating and forming the membrane over a vacuum-forming mold of the type shown in Figure 5. As shown in Figure 5, a vacuum can be applied through a collection of holes along the mold wall. Alternatively, the mold wall can be constructed from a porous, gas-permeable material, which can result in a more uniformly smooth surface on the molded membrane.

MX/a/2021/007240

<img file="MX428429B_D0002.tif" />

IMPI

MEXICAN INSTITUTE OF PROPERTY IO

INDUSTRIAL &lt;or form, the membrane 15 can be moved in relation to the pump chambers 181 to effect pumping action without requiring stretching of the membrane 15 (or at least minimal stretching of the membrane 15), when the membrane 15 is moved to the maximum towards the pump chambers 181 and (potentially) towards contact with separating elements 50 (e.g., as shown in solid line in figure 4 while pumping fluid out of the pump chamber 181), and when the membrane 15 is withdrawn to the maximum from the pump chamber 181 (e.g., as shown in dashed line in figure 4 when fluid is drawn into the pump chamber 181). Impeding membrane stretching 15 can help prevent pressure surges or other changes in fluid supply pressure due to sheet stretching and/or help simplify pump control when seeking to minimize pressure variation during pump operation. Other benefits may be found, including reduced probability of membrane 15 failure (e.g., due to tears in the membrane 15 resulting from stresses placed on the membrane 15 during stretching), and/or improved accuracy in measuring pump delivery volume, as described in more detail below. In one embodiment, portions of pump chamber 151 can be shaped to have a size (e.g., to define a volume) that is approximately 85-110% of pump chamber 181, e.g., if the portions of pump chamber 151 define a volume that is

MX/a/2021/007240 approximately 100% of the pump chamber volume, the portions

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INDUSTRIAL &lt;o of the pump chamber 151 can be laid in the pump chamber 181 and in contact with the separators 50 while at rest and not under stress.

Providing greater control over the pressure used to generate a filling stroke and to deliver fluid into and out of a pump chamber can have several advantages. For example, it may be desirable to apply the lowest possible negative pressure when the pump chamber withdraws fluid from the patient's peritoneal cavity during a drainage cycle. A patient may experience discomfort during the drainage cycle of a treatment, partly due to the negative pressure applied by the pumps during a filling stroke. The added control that a preformed membrane can provide over the negative pressure applied during a filling stroke can help reduce patient discomfort.

A number of other benefits can be achieved by using preformed pump membranes to contour the cassette's pump chamber. For example, the fluid flow rate through the pump chamber can be made more uniform because a constant pressure or vacuum can be applied throughout the pump stroke, which in turn can simplify the process of regulating fluid heating. Furthermore, temperature changes in the cassette pump may have a minor effect on the diaphragm displacement dynamics, as well as the accuracy of pressure measurements within the pump chambers.

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INDUSTRIAL &lt;o

Furthermore, pressure spikes within the fluid lines can be minimized. Also, correlating pressures measured by pressure transducers on the control side (e.g., pneumatic) of the diaphragm with the actual fluid pressure on the pump chamber side of the diaphragm can be simplified. This, in turn, can allow for more accurate measurements of patient head height and fluid source bags prior to therapy, improve the sensitivity of air detection in the pump chamber, and enhance the accuracy of volumetric measurements. Furthermore, eliminating the need to stretch the membrane may allow for the construction and use of pump chambers with larger volumes.

In this configuration, the cassette 24 includes a pair of pump chambers 181 that are formed in the base member 18, although one pump chamber or more than two pump chambers are possible. According to one aspect of the invention, the inner wall of pump chambers 181 includes separating elements 50 that are separated from each other and extend from the inner wall of the pump chamber 18 to help prevent portions of the membrane 15 from making contact with the inner wall of the pump chamber 181. (As shown in the right-side pump chamber 181 in Figure 4, the inner wall is defined by side portions 181a and a bottom portion 181b. The separators 50 extend upwards from the lower portion 181b in this form, but they could extend from the side portions 181a or can be formed from

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0^3 IMPII

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INDUSTRIAL (or other ways.) By preventing contact of the membrane 15 with the inner wall of the pump chamber, the separator elements 50 can provide a dead space (or trap volume) that can help to trap air or other gas in the pump chamber 181 and inhibit the gas from being pumped out of the pump chamber 181 in some circumstances. In other cases, the separators 50 can help direct the gas to an outlet of the pump chamber 181 so that the gas can be removed from the pump chamber 181, e.g., during priming. Also, the separators 50 can help prevent the diaphragm 15 from adhering to the inner wall of the pump chamber and/or allow flow to continue through the pump chamber 181, even when the diaphragm 15 is compressed by contact with the separator elements 50. In addition, the spacers 50 help prevent premature closure of the pump chamber outlet port (openings 187 and/or 191) if the blade makes uneven contact with the inner wall of the pump chamber. Further details regarding the arrangement and/or function of the spacers 50 are provided in U.S. Patents 6,302,653 and 6,382,923, both of which are incorporated herein by reference.

In this configuration, the separator elements 50 are arranged in a stadium seating arrangement such that the separator elements 50 are arranged in a concentric elliptical pattern with the ends of the separator elements 50 increasing in height from the lower portion 181b of the inner wall at a distance away from the

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o center of the pump chamber 181 to form a region in a semi-elliptical dome configuration (shown by dotted line in figure 4). The location of the separator elements 50 such that the ends of the separator elements 50 form a semi-elliptical region that defines the dome region designed to be swept by the pump chamber portions 151 of the membrane 15 can permit a desired dead space volume that minimizes any reduction to the intended stroke capacity of the pump chambers 181. As can be seen in Figure 3 (and Figure 6), The stadium seating arrangement in which the separator elements 50 are arranged may include aisles or breaks 50a in the elliptical pattern. The breaks (or aisles) 50a help maintain an equal gas level along the rows (gaps or dead space) 50b between separator elements 50 as fluid is supplied from pump chamber 181. For example, if the separator elements 50 were arranged in the stadium seating arrangement shown in Figure 6 without breaks (or aisles) 50a or other means of allowing liquid and air to flow between the separator elements 50, the membrane 15 could reach the lowest point in the separator element 50 located at the outermost periphery of the pump chamber 181, trapping any gas or liquid present in the gap between this outermost separator element 50 and the side portions 181a of the pump chamber wall. Similarly, if the membrane 15 reaches its lowest point in any two adjacent separator elements 50, any gas and

MX/a/2021/007240

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o liquid in the gap between the elements 50 can be trapped. In this arrangement, at the end of the pump stroke, air or other gas in the center of the pump chamber 181 could be supplied while the liquid remains in the outer rows. Supply breaks (or passages) 50a or other means of fluid communication between the gaps between separator elements 50 help to maintain an equal gas level along the gaps during pump stroke, so that air or other gas may be inhibited from leaving the pump chamber 181 unless the liquid volume has been substantially supplied.

In certain embodiments, spacer elements 50 and/or the membrane 15 can be arranged so that the membrane 15 generally does not envelop or otherwise deform around the individual spacers 50 when pressed into contact with them, or otherwise extend significantly into the gaps between the spacers 50. This arrangement can reduce any stretching or damage to the membrane 15 caused by wrapping or otherwise deforming around one or more individual spacer elements 50. For example, it has also been found advantageous in this embodiment to make the size of the gaps between spacers 50 approximately equal in width to the width of the spacers 50. This feature has been shown to help prevent deformation of the membrane 15, e.g., sinking of the membrane into the gaps between spacers 50, when the membrane 15 is forced into contact with the

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o separators 50 during a pumping operation.

According to another aspect of the invention, the inner wall of the pump chambers 181 can define a depression that is greater than the space, for example a semi-elliptical or dome-shaped space, designed to be swept by the pump chamber portions 151 of the membrane 15. In such cases, one or more spacer elements 50 may be located below the dome region designed to be swept by the membrane portion 151 rather than extending into that dome region. In certain cases, the ends of spacer elements 50 may define the periphery of the dome region designed to be swept by the membrane 15. The location of the separator elements 50 outside of, or adjacent to, the periphery of the dome region designed to be swept by the membrane portion 151 can have a number of advantages. For example, locating one or more separator elements 50 such that the separator elements are outside of, or adjacent to, the dome region designed to be swept by the flexible membrane provides dead space between the separators and the membrane, as described above, while minimizing any reduction to the designed stroke capacity of the pump chambers 181.

It should be understood that the separating elements 50, if present, in a pump chamber may be arranged in any other suitable way, such as, for example, shown in Figure 7. The left-hand pump chamber 181 in Figure 7 includes separating elements 50

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INDUSTRIAL &lt;o arranged similarly to that in figure 6, but there is only one break or corridor 50a running vertically through the approximate center of pump chamber 181. The spacers 50 can be arranged to define a concave configuration similar to that in Figure 6 (i.e., the upper parts of the spacers 50 can form the semi-elliptical configuration shown in Figures 3 and 4), or they can be arranged in other suitable shapes, such as to form a spherical configuration, a box-like configuration, etc. The right-hand pump chamber 181 in Figure 7 shows an embodiment in which the separators 50 are arranged vertically with gaps 50b between vertically arranged separators 50. As with the left-hand pump chamber, the separators 50 in the right-hand pump chamber 181 can define a semi-elliptical, spherical, box-like, or any other suitably configured depression. It should be understood, however, that the separator elements 50 may have a fixed height, a spatial pattern different from those shown, etc.

Also, the membrane 15 may have separating elements or other features, such as ribs, bulges, ears, grooves, channels, etc., in addition to, or instead of, the separating elements 50. Such features on the membrane 15 may help prevent adhesion of the membrane 15, etc., and/or provide other features, such as helping to control how the sheets bend or otherwise deform when they move during pumping action. For example, bulges or other

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MEXICAN INSTITUTE

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INDUSTRIAL features in membrane 15 can help the sheet deform consistently and avoid folding in the same area(s) during repeated cycles. Folding the same area of ​​membrane 15 in repeated cycles can cause membrane 15 to fail prematurely in the fold area, and therefore features in membrane 15 can help control how and where folding occurs.

In this illustrative embodiment, the base member 18 of the cassette 24 defines a plurality of controllable valve features, fluid paths, and other structures to guide fluid movement in the cassette 24. Figure 6 shows a plan view of the side of the base member 18 of the pump chamber, which is also seen in perspective view in Figure 3. Figure 8 shows a perspective view of a rear side of the base member 18, and Figure 9 shows a plan view of the rear side of the base member 18. The tube 156 for each of the ports 150, 152 and 154 communicates fluidly with a respective valve well 183 formed in the base member 18. The valve wells 183 are fluidly isolated from each other by walls surrounding each valve well 183 and by sealing engagement of the membrane 15 with the walls around the wells 183. As mentioned before, the membrane 15 can sealably engage the walls around each valve well 183 (and other walls of the base member 18) by being pressed into contact with the walls, e.g., when loaded into the cycler 14. The fluid in valve wells 183 can flow into a port

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;or respective valve 184, if the diaphragm 15 is not pressed into sealing engagement with the valve port 184. Therefore, each valve port 184 defines a valve (e.g., a volcano valve) that can be opened and closed by selectively moving a portion of the diaphragm 15 associated with the valve port 184. As described in more detail later, the cycler 14 can selectively control the position of portions of the membrane 15 so that the valve ports (such as ports 184) can be opened or closed to control the flow through the various fluid channels and other paths in the cassette 24. The flow through the valve ports 184 leads to the back side of the base member 18. For the valve ports 184 associated with the heater bag and drain (ports 150 and 152), the valve ports 184 lead to a common channel 200 formed on the back side of the base member 18. As with the valve wells 183, the channel 200 is isolated from other channels and paths of the cassette 24 by the blade 16 making sealing contact with the walls of the base member 18 that form the channel 200. For valve port 184, associated with patient line port 154, flow through port 184 leads to a common channel 202 on the back side of base member 18.

Returning to Figure 6, each of the spigots 160 (shown without caps in Figure 6) communicates fluidly with a respective valve well 185, which are isolated from each other by walls and membrane sealing engagement 15 with the walls that form the

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INDUSTRIAL &lt;o wells 185. The fluid in the valve wells 185 can flow to a respective valve port 186, if the diaphragm 15 is not in sealing engagement with the port 186. (Again, the position of portions of the diaphragm 15 over each valve port 186 can be controlled by the cycler 14 to open and close the valve ports 186.) The flow through the valve ports 186 leads to the back side of the base member 18 and into the common channel 202. Therefore, in accordance with one aspect of the invention, a cassette may have a plurality of solution supply lines (or other lines that provide materials for supplying dialysate) that are connected to a common manifold or channel of the cassette, and each line may have a corresponding valve to control the flow to/from the line with respect to the common manifold or channel. The fluid in channel 202 can flow to lower openings 187 of the pump chambers 181 by means of openings 188 leading to lower pump valve wells 189 (see Figure 6). Flow from the lower pump valve wells 189 can pass through a respective lower pump valve port 190 if a respective portion of the membrane 15 is not pressed into sealing engagement with the port 190. As can be seen in Figure 9, the lower pump valve ports 190 lead to a channel that communicates with the lower openings 187 of the pump chambers 181. Flow from the pump chambers 181 can pass through the upper openings 191 and into a channel that communicates with an upper valve port 192. Flow from the upper valve port 192 (if the diaphragm 15 is not engaged)

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INDUSTRIAL &lt;o sealed with port 192) can pass to a respective upper valve well 194 and to an opening 193 that communicates with the common channel 200 on the rear side of the base member 18.

As will be seen, the cassette 24 can be controlled so that the pump chambers 181 can pump fluid from and/or to any of the ports 150, 152 and 154 and/or any of the spigots 160. For example, fresh dialysate supplied by one of the containers 20, which is connected by a line 30 to one of the spigots 160, can be directed to the common channel 202 by opening the appropriate valve port 186 for the appropriate spigot 160 (and possibly closing other valve ports 186 for other spigots). Also, the lower pump valve ports 190 can be opened and the upper pump valve ports 192 can be closed. Subsequently, the portion of the membrane 15 associated with the pump chambers 181 (i.e., pump membranes 151) can be moved (e.g., away from the base member 18 and the inner wall of the pump chamber) to decrease the pressure in the pump chambers 181, thereby carrying the fluid through the selected spigot 160 through the corresponding valve port 186, into the common channel 202, through the openings 188 and into the lower pump valve wells 189, through the lower (open) pump valve ports 190 and into the pump chambers 181 through the lower openings 187. The valve ports 186 are independently operable, allowing the option to carry fluid through any one or a combination of spigots 160 and

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INDUSTRIAL &lt;o associated source containers 20, in any desired sequence, or simultaneously. (Of course, only one pump chamber 181 needs to be operable to bring the fluid into it. The other pump chamber can be left inoperable and shut off for flow by closing the appropriate lower pump valve port 190.)

With the fluid in the pump chambers 181, the lower pump valve ports 190 can be closed, and the upper pump valve ports 192 can be opened. When the diaphragm 15 is moved towards the base member 18, the pressure in the pump chambers 181 can increase, causing fluid in the pump chambers 181 to pass through the upper openings 191, through the upper (open) pump valve ports 192 and into the upper pump valve wells 194, through the openings 193 and into the common channel 200. The fluid in channel 200 can be directed to the heater bag port 150 and/or the drain port 152 (and to the corresponding heater bag line or drain line) by opening the appropriate valve port 184. In this way, for example, the fluid in one or more of the containers 20 can be directed to the cassette 24 and pumped to the heater bag 22 and/or the drain.

The fluid in the heater bag 22 (e.g., after it has been adequately heated in the heater tray for introduction into the patient) can be transferred to the cassette 24 by opening the valve port 184 to the heater bag port 150, closing the valve ports

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INDUSTRIAL &lt;o of lower pump 190, and opening the upper pump valve ports 192. By moving the portions of the diaphragm 15 associated with the pump chambers 181 away from the base member 18, the pressure in the pump chambers 181 can be reduced, causing fluid to flow from the heater bag 22 and into the pump chambers 181. With the pump chambers 181 filled with heated fluid from the heater bag 22, the upper pump valve ports 192 can be closed and the lower pump valve ports 190 can be opened. To direct the heated dialysate to the patient, the valve port 184 for the patient port 154 can be opened and the valve ports 186 for the spikes 160 closed. The movement of the diaphragm 15 in the pump chambers 181 towards the base member 18 can increase the pressure in the pump chambers 181 causing fluid to flow through the lower pump valve ports 190, through the openings 188 and into the common channel 202 towards, and through the (open) valve port 184 to the patient port 154. This operation can be repeated a suitable number of times to transfer a desired volume of heated dialysate to the patient.

When the patient is being drained, valve port 184 for patient port 154 can be opened, the upper pump valve ports 192 can be closed, and the lower pump valve ports 190 can be opened (with spigot valve ports 186 closed). Diaphragm 15 can be moved to carry fluid from patient port 154.

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INDUSTRIAL &lt;o and towards the pump chambers 181. Subsequently, the lower pump valve ports 190 can be closed, the upper valve ports 192 can be opened, and the valve port 184 for the drain port 152 can be opened. The fluid from the pump chambers 181 can then be pumped to the drain line for disposal or for sampling to a drain or collection container. (Alternatively, the fluid can also be directed to one or more 160 spikes/30 lines for sampling or drainage purposes.) This operation can be repeated until sufficient dialysate is removed from the patient and pumped into the drain.

The heater bag 22 can also serve as a mixing container. Depending on the specific treatment requirements of an individual patient, the dialysate or other solutions with different compositions can be connected to the cassette 24 using suitable solution lines 30 and spigots 160. Measured quantities of each solution can be added to heater bag 22 using cassette 24, and mixed according to one or more predetermined formulas stored in microprocessor memory and accessible by the control system 16. Alternatively, specific treatment parameters can be entered by the user via user interface 144. The control system 16 can be programmed to compute the appropriate mixing requirements based on the type of dialysate or solution containers connected to spikes 160, and can then control the mixing and delivery of the prescribed mixture to the patient.

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INDUSTRIAL &lt;o

According to one aspect of the invention, the pressure applied by the pumps to the dialysate being infused into or removed from the patient can be controlled so that the patient's sensations of pulling or tugging resulting from pressure variations during the drainage and filling operations can be minimized. For example, when draining dialysate, the suction pressure (or vacuum/negative pressure) can be reduced near the end of the drainage process, thus minimizing the patient's sensation of dialysate removal. A similar approach can be used near the end of a filling operation; that is, the delivery pressure (or positive pressure) can be reduced near the end of the filling. Different pressure profiles can be used for different filling and/or draining cycles if the patient is more or less sensitive to fluid movement during different phases of therapy. For example, a relatively higher (or lower) pressure can be used during filling and/or draining cycles when a patient is asleep, compared to when the patient is awake. The cycler 14 can detect the patient's sleep/wake state, e.g., by using an infrared motion detector and inferring sleep if the patient's movement is reduced, or by using a detected change in blood pressure, brain waves, or another parameter indicative of sleep, etc. Alternatively, the cycler 14 can simply ask the patient, "Are you sleeping?" and control the system's operation based on the patient's response (or lack thereof).

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INDUSTRIAL &lt;o

Loading and operating the equipment

Figure 10 shows a perspective view of the APD system 10 of Figure 1 with the cycler door 141 reduced to an open position, exposing a mounting location 145 for the cassette 24 and a carriage 146 for the solution lines 30. (In this embodiment, the door 141 is mounted by a hinge on a lower portion of the door 141 to the cycler housing 82.) When the equipment 12 is loaded, the cassette 24 is placed in the mounting location 145 with the membrane 15 and the pump chamber side of the cassette 24 facing upwards, allowing portions of the membrane 15 associated with the pump chambers and valve ports to interact with a control surface 148 of the cycler 14 when the door 141 is closed. The mounting location 145 can be configured to match the shape of the base member 18, thereby ensuring the proper orientation of the cassette 24 in the mounting location 145. In this illustrative embodiment, the cassette 24 and mounting location 145 are generally rectangular in shape with a single corner of larger radius, requiring the user to place the cassette 24 in a proper orientation in the mounting location 145 or the door 141 will not close. It should be understood, however, that other orientation forms or characteristics for the cassette 24 and/or the mounting location 145 are possible.

According to one aspect of the invention, when the cassette 24 is placed in the mounting location 145, the patient, drain, and heater bag lines 34, 28, and 26 are routed through a channel 40 in the door 141 on the left, as shown in Figure 10. The channel

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INDUSTRIAL &lt;o

40, which may include guides 41 or other features, may contain the patient, drain, and heater bag lines 34, 28, and 26 so that an occluder 147 can selectively close/open the lines for flow. By closing the gate 141, the occluder 147 can compress one or more of the patient, drain, and heater bag lines 34, 28, and 26 against the stop of the occluder 29. Generally, occluder 147 can allow flow through lines 34, 28, and 26 when cycler 14 is operating (and operating properly), but occlude the lines when cycler 14 is reduced in power (and/or is not operating properly). (Occlusion of the lines can be accomplished by pressing on the lines, or otherwise by squeezing the lines to close off the flow path in the lines.) Preferably, occluder 147 can selectively occlude at least the patient and drain lines 34 and 28.

When the cassette 24 is mounted and the door 141 is closed, the cassette side of the pump chamber 24 and the diaphragm 15 can be pressed into contact with the control surface 148, e.g., by an air bladder, spring, or other suitable arrangement in the door 141 behind the mounting location 145 that crushes the cassette 24 between the mounting location 145 and the control surface 148. This cassette 24 containment can press membranes 15 and 16 into contact with the walls and other features of the base member 18, thereby isolating channels and other flow paths from the cassette 24 as desired. The control surface 148 can include a flexible packing, e.g., a sheet of silicone rubber or other material, which is

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INDUSTRIAL &lt;o associated with the membrane 15 and can selectively move portions of the membrane 15 to cause pumping action in the pump chambers 181 and opening/closing of cassette valve ports 24. The control surface 148 can be associated with the various portions of the membrane 15, e.g., placed in intimate contact with each other, so that the portions of the membrane 15 move in response to movement of corresponding portions of the control surface 148. For example, membrane 15 and control surface 148 may be located close to each other, and a suitable vacuum (or pressure that is lower relative to ambient) may be introduced through suitably located vacuum ports on control surface 148, and maintained, between membrane 15 and control surface 148 so that membrane 15 and control surface 148 are essentially glued together. at least in regions of the membrane 15 that require movement to open/close valve ports and/or to cause pumping action. In another embodiment, the membrane 15 and control surface 148 may be bonded together, or otherwise suitably associated.

Before closing door 141 with the loaded cassette 24, one or more solution lines 30 can be loaded into the cart 146. The end of each solution line 30 can include a cap 31 and a region 33 for labeling or attaching an indicator or identifier. The indicator, for example, can be an identification tag that is attached by a snap onto the tube in the indicator region 33. According to one aspect of the invention

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INDUSTRIAL As will be described in more detail later, the carriage 146 and other components of the cycler 14 can be operated to remove the cap(s) 31 from the lines 30, recognize the indicator for each line 30 (which can provide an indication for the type of solution associated with the line, a quantity of solution, etc.) and smoothly engage the lines 30 with a respective pin 160 of the cassette 24. This process can be done in an automated way, e.g., after door 141 is closed and caps 31 and pins 160 are enclosed in a space protected from human contact, potentially reducing the risk of contamination of lines 30 and/or pins 160 when the two joints are connected. For example, when closing door 141, indicator regions 33 can be evaluated (e.g., visually by means of a suitable image-forming device and software-based image recognition, by RFID techniques, etc.) to identify which solutions are associated with which lines 30. This aspect of the invention relating to the ability to detect characteristics of a line 30 by means of an indicator in the region of indicator 33 can provide benefits such as allowing a user to place lines 30 anywhere on the carriage 146 without having an effect on the operation of the system. In other words, since cycler 14 can automatically detect solution line characteristics, there is no need to ensure that specific lines are placed in particular locations on carriage 146 for the system to function properly. Instead, cycler 14 can identify which lines 30 are where, and control cassette 24 and

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INDUSTRIAL &lt;or other system features appropriately. For example, a line 30 and connected container may be designed to receive used dialysate, e.g., for further testing. Since the cycler 14 can identify the presence of the sample supply line 30, the cycler 14 can direct used dialysate to the appropriate spike 160 and line 30. As described earlier, since the 160 pins of the 24 cassette all feed into a common channel, the input of any particular 160 pin can be directed into the 24 cassette in any desired way by controlling the valves and other features of the cassette.

With lines 30 mounted, carriage 146 can be moved to the left as shown in figure 10 (again, while door 141 is closed), placing the caps 31 on a respective tenon cap 63 on a tenon 160 of cassette 24 and adjacent to a cap separator 149. The cap separator 149 can be extended outwards (towards door 141 from inside a depression in the cycler housing 14) to engage the caps 31. (For example, the cap separator 149 may include five fork-shaped elements that engage with a corresponding groove in the caps 31, allowing the cap separator 149 to resist left/right movement of the cap 31 relative to the cap separator 149.) By engaging the caps 31 with the cap separator 149, the caps 31 can also hold the corresponding tenon cap 63. Subsequently, with the 31 covers hooked with corresponding 63 pin covers, the carriage 146 and cover separator 149

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INDUSTRIAL &lt;o can be moved to the right, removing the pin caps 63 from the pins 160 that are engaged with a corresponding cap 31. (A possible advantage of this arrangement is that the pin caps 63 are not removed in locations where no solution line 30 is loaded because the engagement of cap 31 from a solution line 30 is required to remove a pin cap 63. Therefore, if a solution line will not be connected to a spigot 160, the cap on the spigot 160 is left in place. The cap separator 149 can then stop its rightward movement (e.g., by making contact with a stop), while the carriage 146 continues its rightward movement. As a result, the carriage 146 can pull the terminal ends of the lines 30 from the caps 31, which remain attached to the cap separator 149. With the caps 31 removed from the lines 30 (and the pin caps 63 still attached to the caps 31), the cap separator 149 can again be retracted with the caps 31 into the depression in the cycler housing 14, clearing a path for movement of the carriage 146 and the uncapped ends of the lines 30 toward the pins 160. Carriage 146 then moves to the left again, securing the terminal ends of lines 30 with a respective spigot 160 of cassette 24. This connection can be made by the spigots 160 piercing an otherwise closed end of lines 30 (e.g., the spigots can pierce a septum or closed wall at the terminal end), allowing fluid flow from the respective containers 20 to cassette 24. In one modality, the wall or septum can be constructed of a

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o flexible and/or self-sealing material such as, for example, PVC, polypropylene or silicone rubber.

According to one aspect of the invention, the heater bag 22 can be placed in the heater receiving section bag (e.g., a tray) 142, which is exposed by lifting a cover 143. (In this embodiment, the cycler 14 includes a user or operator interface 144 that is pivotally mounted to the housing 82, as described below. To allow the heater bag 22 to be placed in the tray 142, the interface 144 can be pivoted upwards from the tray 142.) As is known in the art, the heater tray 142 can heat the dialysate in the heater bag 22 to a suitable temperature, e.g., a temperature appropriate for introduction into the patient. According to one aspect of the invention, the lid 143 can be closed after placing the heater bag 22 in the tray 142, e.g., to help trap heat to accelerate the heating process, and/or to help prevent touching or other contact with a relatively hot portion of the heater tray 142, such as its heating surfaces. In one embodiment, lid 143 can be locked in a closed position to prevent contact with heated portions of tray 142, e.g., when portions of tray 142 are heated to temperatures that could cause skin burns. Opening of lid 143 can be prevented, e.g., by a lock, until the temperatures beneath lid 143 are sufficiently low.

In accordance with another aspect of the invention, the cycler 14

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INDUSTRIAL &lt;o includes a user or operator interface 144 that is pivotally mounted to the cycler housing 14 and can be folded towards the heater tray 142. With the interface 144 folded, the cover 143 can be closed to cancel the interface 144 and/or prevent contact with the interface 144. Interface 144 can be configured to display information, e.g., graphically, to a user, and to receive user input, e.g., using a touchscreen and graphical user interface. Interface 144 may include other input devices, such as buttons, markers, knobs, pointers, etc. With the equipment 12 connected, and the containers 20 properly positioned, the user can interact with the interface 144 and cause the cycler 14 to start a treatment and/or perform other functions.

However, before starting a dialysis treatment cycle, the cycler 14 must at least prime the cassette 24, patient line 34, heater bag 22, etc., unless the equipment 12 is supplied in a pre-primed condition (e.g., at the manufacturing facility or otherwise before being put into use with the cycler 14). Priming can be performed in a variety of ways, such as by controlling the cassette 24 (namely the pumps and valves) to bring fluid from one or more solution containers 20 via a line 30 and pumping the fluid through the various paths of the cassette 24 to remove air from the cassette 24. The dialysate can be pumped into the heater bag 22, e.g., for warming before being administered to the patient. Once the 24-tooth cassette and 26-tooth heater bag line are primed, the 14-tooth cycler can then prime the

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INDUSTRIAL &lt;o patient line 34. In one mode, patient line 34 can be primed by connecting line 34 (e.g., via connector 36) to a suitable port or other connection point on cycler 14 and causing cassette 24 to pump fluid into patient line 34. The port or connection point on the cycler 14 can be arranged to detect the arrival of fluid at the end of the patient line (e.g., optically, by a conductive sensor, or otherwise), thereby detecting that the patient line is primed. As described earlier, different types of equipment 12 can have patient lines 34 of different sizes, e.g., adult or pediatric size. According to one aspect of the invention, the cycler 14 can detect the type of cassette 24 (or at least the type of patient line 34) and control the cycler 14 and cassette 24 accordingly. For example, the cycler 14 can determine a volume of fluid supplied by a pump to the cassette, required to prime the patient line 34, and based on that volume, determine the size of the patient line 34. Other techniques can be used, such as recognizing a barcode or other indicator on cassette 24, patient line 34, or another component that indicates the type of patient line.

Figure 11 shows a perspective view of the inner side of door 141 disconnected from housing 82 of cycler 14. This view shows more clearly how lines 30 are received in corresponding slots in door 141 and carriage 146 such that the indicator region 33 is captured in a specific slot of carriage 146. With the

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MEXICAN INSTITUTE

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INDUSTRIAL &lt;o indicator in the indicator region 33 appropriately located when the tube is mounted to the cart 146, a reader or other device can identify indications from the indicator, e.g., representing a type of solution in the container 20 connected to line 30, a quantity of solution, a date of manufacture, a manufacturer's identity, etc. The carriage 146 is mounted on a pair of guides 130 at its upper and lower ends (only the lower guide 130 is shown in Figure 11). Therefore, the carriage 146 can be moved from left to right in the door 141 along the guides 130. When moving towards the mounting location of the cassette 145 (on the right in Figure 11), the carriage 146 can be moved until it makes contact with the stops 131.

Figure 12 shows a perspective view of a carriage drive assembly 132 in a first embodiment that operates to move the carriage 146 to remove the caps from the pins 160 in the cassette, remove caps 31 on the solution lines 30, and connect lines 30 to the pins 160. A drive element 133 is arranged to move from left to right along rods 134. In this illustrative embodiment, an air bladder powers the movement of the driving element 133 along the rods 134, but any suitable drive mechanism may be used, including motors, hydraulic systems, etc. The driving element 133 has forward-extending lugs 135 that engage with corresponding grooves 146a in the carriage 146 (see Figure 11, which shows an upper groove 146a in the carriage 146). The engagement of the lugs 135 with the

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INDUSTRIAL &lt;o slots 146a allows the drive element 133 to move the carriage 146 along the guides 130. The drive element 133 also includes a window 136, through which an imaging device, such as a CCD or CMOS imager, can capture image information from the indicators in the indicator regions 33 on the lines 30 mounted to the carriage 146. Image information regarding the indicators in indicator regions 33 can be provided from the imaging device to the control system 16, which can obtain clues, e.g., by image analysis. The drive element 133 can selectively move the cap separator 149 both to the left and to the right along the rods 134. The lid separator 149 extends back and forth using a suitable drive mechanism, such as a pneumatic bladder.

Figure 13 shows a left-side perspective view of the carriage drive assembly 132, which shows more clearly how a separator element of the cap separator 149 is arranged to move in and out (a direction generally perpendicular to the rods 134) along rods 149a in the cap separator housing 149. Each of the semicircular cuts in the separator element can engage a corresponding slot in a cap 31 in a line 30 as it extends forward when the cap 31 is properly positioned in front of the separator 149 by the drive element 133 and carriage 146. With the separator element engaged with the caps 31, the cap separator 149 can be moved with the carriage 146 as the drive element 133

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INDUSTRIAL &lt;o moves. Figure 14 shows a partial rear view of the carriage drive assembly 132. In this embodiment, the drive element 133 is moved toward the mounting location 145 of the cassette 24 by a first air bladder 137 that expands to force the drive element 133 to move to the right in Figure 14. The drive element can be moved to the left by a second air bladder 138. Alternatively, the driving element 133 can be moved back and forth by means of one or more motors coupled to a linear driving gear assembly, such as a ball screw assembly (in which the carriage driving assembly is fixed to a ball nut), or an assembly of, for example, rack and pinion. The separator element 1491 of the cap separator 149 can be moved in and out of the cap separator housing by a third bladder, or alternatively, by a motor coupled to a linear drive assembly, as described above.

Figures 15-18 show another embodiment of a carriage drive assembly 132 and lid separator 149. As can be seen from the rear view of the carriage drive assembly 132 in Figure 15, in this embodiment the drive element 133 is moved to the right and left by a screw drive mechanism 1321. As can be seen in the right rear perspective view of the carriage drive assembly 132 in Figure 16, the separator element is moved outward and inward by an air bladder 139, although other arrangements are possible as described above.

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INDUSTRIAL &lt;o

Figures 17 and 18 show left and right front perspective views of another modality for the separator element 1491 of the lid separator 149. The separator element 1491 in the modality shown in Figure 13 included only fork-shaped elements arranged to hook with a lid 31 of a solution line 30. In the embodiments of Figures 17 and 18, the separator element 1491 includes not only the fork-shaped elements 60, but also swing arms 61 that are pivotally mounted to the separator element 1491. As will be explained in more detail later, the swing arms 61 assist in removing the spigot caps 63 from the cassette 24. Each of the swing arms 61 includes a solution line cap engagement portion 61a and a spigot cap engagement portion 61b. The swing arms 61 are normally deflected to move so that the tenon cap engagement portions 61b are located close to the spacer element 1491, as shown in the swing arms 61 in Figure 18. However, when cap 31 is received by a corresponding fork-shaped element 60, the solution line cap engagement portion 61a makes contact with cap 31, causing the swing arm 61 to pivotally rotate so that the pin cap engagement portion 61b moves away from the separating element 1491, as shown in Figure 17. This position allows the hook portion of tenon cap 61b to make contact with a tenon cap 63, specifically a tab on the tenon cap 63.

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INDUSTRIAL &lt;o

Figure 19 shows a front view of the separator element 1491 and the location of several cross-sectional views shown in Figures 20-22. Figure 20 shows the swing arm 61 without a spigot cap 63 or solution line cap 31 located near the separator element 1491. The swing arm 61 is pivotally mounted to the spacer element 1491 at a point approximately halfway between the spigot cap engagement portion 61b and the solution cap engagement portion 61a. As mentioned before, the swing arm 61 is normally deflected to rotate in a counterclockwise direction as shown in Figure 20, so that the spigot cap engagement portion 61b is located close to the spacer element 1491. Figure 21 shows that the swing arm 61 maintains this position (i.e., with the spigot cap engagement portion 61b located close to the separator element 1491) even when the separator element 1491 advances toward a spigot cap 63 in the absence of a solution line cap 31 that engages with the fork-shaped element 60. As a result, the swing arm 61 will not rotate clockwise or engage the spigot cap 63 unless a solution line cap 31 is present. Therefore, a spigot cap 63 that does not engage with a solution line cap 31 will not be removed from cassette 24.

Figure 22 shows an example in which a solution line cap 31 is engaged with the fork-shaped element 60 and makes contact with the solution cap engagement portion line 61a of the

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INDUSTRIAL &lt;o swing arm 61. This causes the swing arm 61 to rotate in a clockwise direction (as shown in the figure) and the tenon cap engagement portion 61b to engage with the tenon cap 63. In this embodiment, the engagement of portion 61b includes positioning portion 61b adjacent to a second tab 63a on the tenon cap 63 so that when the separator element 1491 is moved to the right (as shown in Figure 22), the tenon cap engagement portion 61b will make contact with the second tab 63a and help to pull the tenon cap 63 off the corresponding tenon 160. Note that the solution line cap 31 is made of a flexible material, such as silicone rubber, to allow a prong 63c of the spigot cap 63 to stretch the hole 31b of the cap 31 (see figure 23) and be captured by an internal groove or circumferential depression within the cap 31. A first tab 63b on the spigot cap 63 acts as a stop for the end of the solution line cap 31. The walls that define the groove or depression in the hole 31b of the cap 31 can be symmetrically or preferably asymmetrically arranged to conform to the shape of the prong 63c. (See figure 33 for a cross-sectional view of the cap 31 and the groove or depression.) The second tab 63a on the tenon cap 63 acts as a tooth with which the tenon cap engagement portion 61b of the swing arm 61 engages in order to provide additional pulling force for disengaging the tenon cap 63 from the tenon 160, if necessary.

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Figure 23 shows an exploded close-up view of the

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INDUSTRIAL &lt;o connector end 30a of a solution line 30 with cap 31 removed. (In Figure 23, caps 31 are shown without a finger pull ring like the one shown in Figure 24 for clarity. A pull ring need not be present for operation of cap 31 with cycler 14. It may be useful, however, to allow an operator to manually remove cap 31 from the terminal end of solution line 30, if necessary.) In this illustrative embodiment, the indicator in the region of indicator 33 has an annular shape that is sized and configured to fit within a corresponding slot of carriage 146 when mounted as shown in figures 10 and 11. Of course, the indicator can take any suitable shape. Cap 31 is arranged to fit over the distal end of connector end 30a, which has an internal hole, seals, and/or other features to permit a leak-free connection with a 160 spigot on a 24 cassette. Connector end 30a may include a pierceable wall or septum (not shown - see Figure 33, number 30b) that prevents leakage of solution into line 30 of connector end 30a, even when cap 31 is removed. The wall or septum can be pierced by the pin 160 when the connector end 30a is attached to the cassette 24, allowing flow from line 30 to the cassette 24. As described earlier, the cap 31 can include a slot 31a that is engaged by a fork-shaped element 60 of the cap separator 149. The cap 31 can also include a hole 31b that is arranged to receive a pin cap 63. The hole 31b and the cap 31 can be arranged so that

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INDUSTRIAL &lt;o that, with the cap separator 149 engaged with the groove 31a and the dowel cap 63 of a dowel 160 received in the hole 31b, the cap 31 can properly hold the dowel cap 63 so that when the carriage 146/cap separator 149 pulls the cap 31 into the cassette housing 24, the dowel cap 63 is removed from the dowel 160 and carried by the cap 31. This removal can be assisted by the swing arm 61, which engages with the second tab 63 or another feature on the pin cap 63, as previously described. Subsequently, the cap 31 and pin cap 63 can be removed from the connector end 30a and the line 30 attached to the pin 160 by the carriage 146.

Once the treatment is complete, or line 30 and/or cassette 24 are ready to be removed from cycler 14, cap 31 and fixed pin cap 63 can be reassembled onto pin 160 and line 30 before door 141 is allowed to be opened and cassette 24 and line 30 removed from cycler 14. Alternatively, cassette 24 and solution containers with lines 30 can be removed en bloc from cycler 14 without reassembling cap 31 and fixed pin cap 63. One advantage of this approach includes a simplified removal process, and it avoids any potential fluid leakage into the cycler or surrounding area due to improper reassembly or inadequate sealing of the caps.

Figures 24-32 show a perspective view of carriage 146, lid separator 149, and cassette 24 during an automatic line assembly and connection operation. Door 141 and other components of

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The INDUSTRIAL cycler is not shown for clarity. In Figure 24, the carriage 146 is shown in a folded position, as if the door 141 were open in the position shown in Figure 8. Lines 30 and cassette 24 are positioned to be lowered into door 141. In Figure 25, lines 30 are loaded onto carriage 146 and cassette 24 is loaded into mounting location 145. At this point, door 141 can be closed to prepare the cycler for operation. In Figure 26, door 141 is closed. Identifiers or indicators located in the region of indicator 33 on lines 30 can be read to identify various line characteristics so that the cycler 14 can determine which solutions, how much solution, etc., are loaded. In Figure 27, carriage 146 has moved to the left, engaging caps 31 on lines 30 with corresponding pin caps 63 on cassette 24. During the movement, the driving element 133 engages the cap separator 149 and moves the cap separator 149 to the left as well. However, the cap separator 149 remains in a retracted position. In Figure 28, the cap separator 149 moves forward to engage the fork-shaped elements 60 with the caps 31, thereby engaging the caps 31 that have been attached to the tenon caps 63. If present, the swing arms 61 can be moved into a locking position with respect to the tenon caps 63. Then, as shown in Figure 29, the carriage 146 and cap separator 149 move to the right, away from the cassette 24, to pull the caps 31 and tenon caps 63 from the corresponding tenons 160 in the cassette 24.

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INDUSTRIAL &lt;o

It is during this movement that the swing arms 61, if present, can help pull the spigot caps 63 off the cassette 24. In Figure 30, the cap separator 149 has stopped its movement to the right, while the carriage 146 continues to move away from the cassette 24. This causes the connector ends 30a of the lines 30 to be pulled from the caps 31, leaving the caps 31 and spike caps 63 mounted on the cap separator 149 by means of the fork-shaped elements 60.

In Figure 31, the cap separator 149 retracts, clearing a path for the carriage 146 to move back toward the cassette 24. In Figure 32, the carriage 146 moves toward the cassette 24 to engage the connector ends 30a of the lines 30 with the corresponding pins 160 of the cassette 24. The carriage 146 can remain in this position during cycler operation. Once the treatment is complete, the movements shown in Figures 24-32 can be reversed to re-cap spikes 160 and solution lines 30 and remove cassette 24 and/or lines 30 from cycler 14.

To further illustrate the removal of caps 31 and spigot caps 63, Figure 33 shows a cross-sectional view of cassette 24 at five different stages of line connection 30. At the top spigot 160, the spigot cap 63 is still in place on the spigot 160 and the solution line 30 is located away from the cassette 24, as in Figure 26. On the second peg 160 below the upper one, the solution line 30 and cap 31 are hooked onto the peg cap 63, as in figures 27 and 28. In this

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At the third pin 160 from the top, the solution line 30, cap 31, and pin cap 63 have moved away from the cassette 24, as in Figure 29. At this point, the cap separator 149 can stop moving to the right. At the fourth pin 160 from the top, the solution line 30 continues moving to the right, removing cap 31 from line 30, as in Figure 30. Once caps 31 and 63 are retracted, solution line 30 moves to the left to smoothly connect connector end 30a of line 30 to spike 160, as in figure 32.

Several sensors can be used to help verify that carriage 146 and lid separator 149 move completely to their expected positions. In one embodiment, the carriage drive assembly 132 can be equipped with six Hall-effect sensors (not shown): four for carriage 146 and two for lid separator 149. A first lid separator sensor can be positioned to detect when lid separator 149 is fully retracted. A second cap separator sensor can be positioned to detect when the cap separator 149 is fully extended. A first carriage sensor can be positioned to detect when the carriage 146 is in the start position, i.e., in the position to allow loading of cassette 24 and lines 30. A second carriage sensor can be positioned to detect when the carriage 146 is in the position to have engaged the pin caps 63. A third car sensor can be positioned to detect when car 146 has

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INDUSTRIAL &lt;o reached a position to have removed the caps 31 from the lines 30. A fourth carriage sensor may be positioned to detect when the carriage 146 has moved to a position to have engaged the connector ends 30a of the lines 30 with the corresponding pins 160 of the cassette 24. In other embodiments, a single sensor may be used to detect more than one of the carriage positions described above. The lid separator and carriage sensors can provide input signals to an electronic control console (self-connecting console), which in turn can communicate specific confirmation or error codes to the user via user interface 144.

There may be an advantage to adjusting the force with which the carriage 146 engages the pin caps 63, depending on how many lines 30 are being installed. The force required to complete a connection to the cassette 24 increases with the number of caps 31 that must be engaged with the pin caps 63. The sensing device for detecting and reading information from the line indicators in the indicator regions 33 can also be used to provide the data required to adjust the force applied to the driving element 133. The force can be generated by a number of devices, including, for example, the first air bladder 137, or a linear actuator such as a motor/ball screw. An electronic control console (such as, for example, the self-connecting console) can be programmed to receive input from the line detection sensor(s), and send an appropriate control signal either to the motor of a linear actuator,

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INDUSTRIAL &lt;ooa the pneumatic valve that controls the inflation of the air bladder 137. The controller 16 can control the degree or speed of movement of the driving element 133, for example by modulating the voltage applied to the motor of a linear actuator, or by modulating the pneumatic valve that controls the inflation of the bladder 137.

The aspect of the invention whereby the caps 31 on the lines 30 are removed together with the caps 63 on the pins 160 of the cassette 24 can provide advantages other than simplicity of operation. For example, since the pin caps 63 are removed by means of their engagement with a cap 31 on a line 30, if there is no line 30 mounted in a particular slot on the carriage 146, the pin cap 63 in that position will not be removed. For example, although the cassette 24 includes five pins 160 and corresponding pin caps 63, the cycler 14 can operate with four or fewer (even no) lines 30 associated with the cycler 14. For those slots in the carriage 146 where no line 30 is present, there will be no cap 31, and therefore no mechanism by which a pin cap 63 in that position can be removed. Therefore, if there is no line 30 connected to a particular spigot 160, the cap 63 on that spigot 160 can remain in place during use of the cassette 24. This can help prevent leakage at the spigot 160 and/or contamination at the spigot 160.

The cassette 24 in Figure 33 includes new features that are different from those shown, for example, in the mode shown in Figures 3, 4, and 6. In the mode shown in Figures 3, 4, and 6, the bag port of

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INDUSTRIAL &lt;o heater 150, drain line port 152 and patient line port 154 are arranged to have a center tube 156 and a skirt 158. However, as mentioned before and as shown in Figure 33, ports 150, 152, 154 may include only the center tube 156 and not a skirt 158. This is also shown in Figure 34. The modality illustrated in figure 34 includes raised ribs formed on the outer surface of the pump chamber 181 on the left side. The raised ribs can also be provided on the right-hand side of the pump chamber 181, and can provide additional contact points of the outer walls of the pump chambers 181 with the mechanism on the door 141 at the mounting location of the cassette 145, which presses the cassette against the control surface 148 when the door 141 is closed. The raised ribs are not required, and instead the pump chambers 181 may lack ribs or other features, as shown for the right-hand pump chamber 181 in Figure 34. Similarly, the spigots 160 in the embodiments of Figures 3, 4, and 6 do not include a skirt or similar feature at the base of the spigot 160, whereas the embodiment in Figure 33 includes a skirt 160a. This is also shown in Figure 34. Skirt 160a can be arranged to receive the end of the tenon cap 63 in a depression between skirt 160a and tenon 160, helping to form a seal between tenon 160 and tenon cap 63.

Another inventive feature shown in Figure 33 relates to the arrangement of the distal tip of the spike 163 and the lumen 159 through the

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INDUSTRIAL &lt;o tenon 160. In this respect, the distal tip of the tenon 160 is located on or near the longitudinal axis of the tenon 160, which generally runs along the geometric center of the tenon 160. The location of the distal tip of the 160 spike on or near the longitudinal axis can help facilitate alignment tolerances when the 160 spike is engaged with a corresponding solution line 30 and help the 160 spike pierce a septum or membrane 30b at the connector end 30a of the line 30. As a result, the lumen 159 of the tenon 160 is generally located off the longitudinal axis of the tenon 160, e.g., near the bottom of the tenon 160 as shown in Figure 33 and as shown in an extreme view of a tenon 160 in Figure 35. Also, the distal end of the 160 spike has a somewhat reduced diameter compared to more proximal portions of the 160 spike (in this modality, the 160 spike actually has a change in diameter at approximately 2/3 of the length of the 160 spike from the 18 body). The reduced diameter of the 160 pin at the distal end can provide clearance between the 160 pin and the inner wall of line 30, thus allowing the 30b septum room to bend back to be placed between the 160 pin and line 30 when it is pierced by the 160 pin. The stepped feature on the 160 spigot can also be arranged to engage line 30 at the location where the 30b septum is connected to the inner wall of line 30, thereby increasing a seal formed between line 30 and spigot 160.

Once cassette 24 and lines 30 are loaded into the

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100 Cycler 14, the cycler 14 must control the operation of the cassette 24 to move fluid from the solution lines 30 to the heater bag 22 and to the patient. Figure 36 shows a plan view of the control surface 148 of the cycler 14 that interacts with the pump chamber side of the cassette 24 (e.g., shown in Figure 6) to cause pumping and flow path control in the cassette 24. When at rest, the control surface 148, which can be described as a type of packing and comprises a silicone rubber sheet, is generally flat. The valve control regions 1481 may (or may not) be defined on the control surface 148, e.g., by markings, grooves, ribs, or other features within or on the sheet surface, and may be arranged to be movable in a direction generally transverse to the plane of the sheet. By moving in/out, the valve control regions 1481 can move associated portions of the membrane 15 over the cassette 24 to open and close respective valve ports 184, 186, 190, and 192 of the cassette 24, and thus control the flow in the cassette 24. Two larger regions, pump control regions 1482, can also be movable to move associated configured portions 151 of the membrane 15 that cooperate with the pump chambers 181. Similar to the configured portions 151 of the membrane 15, the pump control regions 1482 can be configured in a way that corresponds to the shape of the pump chambers 181 when the control regions 1482 are extended within the pump chambers 181. In this way, the portion

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101 The control sheet 148 in the pump control regions 1482 does not necessarily have to be stretched or otherwise elastically deformed during pumping operation.

Each of regions 1481 and 1482 may have an associated vacuum or evacuation port 1483 that can be used to remove all or substantially all of any air or other fluid that may be present between the membrane 15 of the cassette 24, and the control surface 148 of the cycler 14, e.g., after the cassette 24 is loaded into the cycler 14 and the door 141 is closed. This can help ensure close contact of the diaphragm 15 with the control regions 1481 and 1482, and help control the delivery of desired volumes with pump operation and/or the open/closed state of the various valve ports. Note that the vacuum ports 1482 are formed in locations where the control surface 148 will not be pressed into contact with a wall or other relatively rigid feature of the cassette 24. For example, according to one aspect of the invention, one or both of the cassette pump chambers may include a vacuum vent free space region formed adjacent to the pump chamber. In this illustrative embodiment, as shown in Figures 3 and 6, the base member 18 may include vacuum vent clearance or extension features 182 (e.g., areas in depression that are fluidly connected to the pump chambers) adjacent to and outside the oval-shaped depressions formed by the pump chambers 181 to allow the vacuum vent port 1483

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102 For the pump control region 1482, remove any air or fluid from between the diaphragm 15 and the control surface 148 (e.g., due to a rupture of the diaphragm 15) without obstruction. The extension feature may also be located within the perimeter of the pump chamber 181. However, the location of the vent port feature 182 outside the perimeter of the pump chamber 181 can conserve more of the pump chamber volume for pumping liquids, e.g., allows the entire footprint of the pump chamber 181 to be used for pumping the dialysate. Preferably, the extension feature 182 is located vertically lower relative to the pump chamber 181, so that any fluid leaking between the diaphragm 15 and the control surface 148 is expelled through the vacuum port 1483 at the first opportunity. Similarly, the vacuum ports 1483 associated with the valves 1481 are preferably located vertically lower relative to the valves 1481.

Control regions 1481 and 1482 can be moved by controlling a pneumatic pressure and/or volume on one side of the control surface 148 opposite the cassette 24, e.g., on a rear side of the rubber sheet forming the control surface 148. For example, as shown in Figure 37, the control surface 148 can be backed up by a mating block 170 having control chambers 171 located in association with each control region 1481, 1482, and which are isolated from each other (or at least can be controlled independently of each other).

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103 (others if desired). The pairing block surface 170 forms an interface with the cassette 24 when the cassette 24 is pressed in operational association with the control surface 148 backed by the pairing block 170. The control chambers of the matching block 170 are therefore coupled to the complementary valve or pump chambers of the cassette 24, interleaved control regions 1481 and 1482 of control surface 148 adjacent to the matching block 170, and the associated membrane regions 15 (such as the configured portion 151) adjacent to the cassette 24. Air or other control fluid can be moved into or out of the control chambers 171 of the matching block 170 for regions 1481, 1482, thereby moving the control regions 1481, 1482 as desired to open/close valve ports of cassette 24 and/or effect pumping action in pump chambers 181. In an illustrative embodiment shown in Figure 37, the control chambers 171 can be arranged as cylindrically configured regions supporting each of the valve control regions 1481 and a pair of elliptical recesses supporting the pump control regions 1482. Fluid control ports can be provided for each control chamber 171 so that the cycler 14 can control the fluid volume and/or fluid pressure in each of the control chambers. For example, the matching block 170 can be matched with a manifold 172 that includes various ports, channels, openings, gaps, and/or other features that communicate with the control chambers 171 and allow the

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104 Pneumatic pressure/vacuum is applied to control chambers 171. Although not shown, control of pneumatic pressure/vacuum can be carried out in any suitable way, such as through the use of controllable valves, pumps, pressure sensors, accumulators, etc. Of course, it can be understood that control regions 1481, 1482 can be moved in other ways, such as by gravity-based systems, hydraulic systems, and/or mechanical systems (such as by linear motors, etc.), or by a combination of systems including pneumatic, hydraulic, gravity-based, and mechanical systems.

According to one aspect of the invention, the vacuum ports 1483 can be used to detect leaks in the membrane 15, e.g., a liquid sensor in a conduit or chamber connected to a vacuum port 1483 can detect liquid if the membrane 15 is punctured or liquid is otherwise introduced between the membrane 15 and the control surface 148. For example, vacuum ports 1483 can be aligned with and sealably associated with complementary vacuum ports 173 in a mating block 170, which in turn can be sealably associated with fluid passages 1721 leading to a common fluid collection chamber 1722 in the manifold 172. The fluid collection chamber 1722 may contain an inlet through which a vacuum can be applied and distributed to all the vacuum ports 1483 of the control surface 148. By applying a vacuum to the fluid collection chamber 1722, fluid can be drawn from each of the vacuum ports 173 and 1483, thereby removing

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105 fluid from any space between the membrane 15 and the control surface 148 in the various control regions. However, if fluid is present in one or more of the regions, the associated vacuum port 1483 can carry the fluid to the vacuum ports 173 and to the lines 1721 leading to the fluid collection chamber 1722. Any such liquid can be collected in the fluid collection chamber 1722 and detected by one or more suitable sensors, e.g., a pair of conductivity sensors that detect a change in conductivity in chamber 1722, indicating the presence of liquid. In this configuration, the sensors can be located on the lower side of the fluid collection chamber 1722, while a vacuum source connects to chamber 1722 at its upper end. Therefore, if liquid is drawn into the fluid collection chamber 1722, it can be detected before the liquid level reaches the vacuum source. Optionally, a hydrophobic filter, valve, or other component can be placed at the connection point of the vacuum source to chamber 1722 to further prevent liquid from entering the vacuum source. In this way, a liquid leak can be detected and controller 16 can take action against it (e.g., generating an alert, closing liquid inlet valves and ceasing pumping operations) before the vacuum source valve is at risk of being contaminated by the liquid.

In one configuration, the inner wall of the control chambers 171 may include raised elements somewhat analogous to the elements

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106 pump chamber separators 50, e.g., as shown in Figure 37 for the control chambers 171 associated with the pump control regions 1482. These raised elements may take the form of plateau features, ribs, or other projections that keep the control ports in depression away from the fully retracted control regions 1482. This arrangement may allow a more uniform distribution of pressure or vacuum in the control chamber 171, and prevent premature blockage of any control port by the control surface 148. A preformed control surface 148 (at least in the pump control regions) may not be under significant tensile force when fully extended against either the inner wall of the cassette pump chamber 24 during a delivery stroke, or the inner wall of the control chamber 171 during a filling stroke. Therefore, it may be possible for control region 1482 to extend asymmetrically within control chamber 171, causing control region 1482 to prematurely close one or more control chamber ports before the chamber is fully evacuated. Having features on the inner surface of the control chamber 171 that prevent contact between the control region 1482 and the control ports can help ensure that the control region 1482 can make uniform contact with the inner wall of the control chamber during a fill stroke.

As suggested earlier, cycler 14 may include a system of

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107 Control 16, with a data processor in electrical communication with the various valves, pressure sensors, motors, etc., of the system, is preferably configured to control these components according to a desired operating sequence or protocol. Control 16 may include circuitry, programming, computer memory, electrical connections, and/or other components appropriate for performing a specified task. The system may include pumps, tanks, manifolds, valves, or other components to generate desired air pressure or other fluid pressure (either positive pressure - above atmospheric pressure or some other reference - or negative pressure or vacuum - below atmospheric pressure or some other reference) to control the operation of control surface regions 148, and other pneumatically operated components. Additional details regarding control system 16 (or at least portions thereof) are provided later.

In an illustrative embodiment, the pressure in the control chamber of pump 171 can be controlled by a binary valve, e.g., which opens to expose the control chamber 171 to a suitable pressure/vacuum and closes to cut off the pressure/vacuum source. The binary valve can be controlled using a sawtooth control signal that can be modulated to control the pressure in the control chamber of pump 171. For example, during a pump supply stroke (i.e., one in which positive pressure is introduced into the pump control chamber 171 to move the diaphragm 15/control surface 148 and force the

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108 (liquid to exit from pump chamber 181), the binary valve can be driven by the sawtooth signal to open and close at a relatively rapid speed to establish a suitable pressure in the control chamber 171 (e.g., a pressure between approximately 70-90 mmHg). If the pressure in control chamber 171 rises above approximately 90 mmHg, the sawtooth signal can be adjusted to close the binary valve for a longer period. If the pressure falls below approximately 70 mmHg in control chamber 171, the sawtooth control signal can again be applied to the binary valve to raise the pressure in control chamber 171. Therefore, during a typical pump operation, the binary valve will open and close multiple times, and may be closed for one or more extended periods, so that the pressure at which the liquid is forced from the pump chamber 181 is maintained at a desired level or range (e.g., approximately 7090 mmHg).

In some embodiments and in accordance with one aspect of the invention, it may be useful to detect the end of the stroke of the diaphragm 15/pump control region 1482, e.g., when the diaphragm 15 makes contact with the spacers 50 in the pump chamber 181 or the pump control region 1482 makes contact with the wall of the pump control chamber 171. For example, during a pumping operation, the detection of the end of a stroke may indicate that the diaphragm 15/pump control region 1482 movement should be reversed to initiate a new pump cycle (for

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109 fill the pump chamber 181 or pump fluid from the pump chamber 181). In an illustrative embodiment in which the pressure in the control chamber 171 for a pump is controlled by a binary valve driven by a sawtooth control signal, the pressure in the pump chamber 181 will fluctuate at a relatively high frequency, e.g., a frequency at or near the frequency at which the binary valve is opened and closed. A pressure sensor in the control chamber 171 can detect this fluctuation, which generally has a higher amplitude when the diaphragm 15/pump control region 1482 is not in contact with the inner wall of the pump chamber 181 or the wall of the pump control chamber 171. However, once the diaphragm 15/pump control region 1482 makes contact with the inner wall of the pump chamber 181 or the wall of the pump control chamber 171 (i.e., the stroke end), the pressure fluctuation is generally dampened or otherwise changes in a way that is detectable by the pressure sensor in the pump control chamber 171. This change in pressure fluctuation can be used to identify the end of the stroke, and the pump and other components of the 24 cassette and/or 14 cycler can be controlled accordingly.

Occluder

In one aspect of the invention, an occluder for opening/closing one or more flexible lines may include a pair of opposing occluding members, which can be configured as elastic elements, such as plates.

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110 Flat springs made of spring steel (e.g., leaf springs), having a force actuator configured to apply a force to one or both of the occluding members to operate the occluder. In certain embodiments, the force actuator may comprise an expandable or enlargeable member located between the elastic elements. With the expandable member in a reduced size, the elastic elements can be in a flat or near-flat position and drive a clamp head to engage one or more lines, tightening them. However, when the expandable member drives the elastic elements apart, the elastic elements can bend and retract the clamp head, releasing the lines and allowing flow through them. In other embodiments, the occluding members may be essentially rigid with respect to the force levels applied by the force actuator. In certain embodiments, the force actuator may apply a force to one or both opposing occluding members to increase the distance between the occluding members in at least a portion of the region where they oppose each other, in order to effect the opening or closing of the flexible tube.

Figure 38 shows an exploded view and Figure 39 shows a partially assembled view of an illustrative version of an occluder 147 that can be used to close, or occlude, the patient and drain lines 34 and 28, and/or other lines in the cycler 14 or equipment 12 (such as, for example, the heater bag line 26). The occluder 147 includes an optional clamp head 161, e.g., a leaf-shaped element.

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111 A generally flat clamp that makes contact with the tubes to press the tubes against the gate 141 and tighten the tubes closed. In other embodiments, the function of the clamp head could be replaced by an extension edge of one or both of the occluding members 165. The clamp head 161 includes a packing 162, such as an O-ring or other member, which cooperates with the clamp head 161 to help resist the entry of fluid (air or liquid for example) into the cycler housing 14, e.g., in the event of leakage in one of the occluded lines. The bellows packing 162 is mounted to, and the gripper head 161 passes through, a gripper head guide 163 that is mounted to the front panel of the cycler housing, i.e., the panel exposed when the door 141 is opened. The gripper head guide 163 allows the gripper head 161 to move in and out of the gripper head guide 163 without binding and/or substantial resistance to the sliding movement of the gripper head 161. A pivot shaft 164 is attached to a pair of opposing occluder members, comprising in the illustrated embodiment spring plates 165, each of which includes a hook-shaped pivot shaft bearing, e.g., such as that found in standard door hinges, to the clamp head 161. That is, the openings in the shaft guides in the gripper head 161, and the openings formed by the hook-shaped bearings in the spring plates 165 are aligned with each other, and the pivot shaft 164 is inserted through the openings, so that the gripper head 161 and the spring plates 165 are pivotally connected to each other. The spring plates 165 can be

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112 made of any suitable material, such as steel, and may be arranged to be generally flat when not under stress. The opposite end of the spring plates 165 includes similar hook-shaped bearings, which are pivotally connected to a linear adjuster 167 by a second pivot shaft 164. In this embodiment, the force actuator comprises a bladder 166 that is located between the spring plates 165 and arranged so that when fluid (e.g., pressurized air) is introduced into the bladder, the bladder can expand and push the spring plates 165 away from each other in a region between the pivot arrows 164. A linear adjuster 167 is fixed to the cycler housing 82 while the gripper head 161 is allowed to float, although its movement is guided by the gripper head guide 163. The linear adjuster 167 includes slotted holes at its lower end, allowing the entire assembly to be adjusted into position and thus allowing the gripper head to be properly located when the occluder 147 is installed in the cycler 14. A tensioner 168 or other arrangement can be used to help adjust the piston of the linear adjuster 167 in relation to the housing 82. That is, the clamp head 161 generally needs to be positioned appropriately so that, with the spring plates 165 positioned close together and the bladder 166 substantially emptied or at ambient pressure, the clamp head 161 properly presses on the patient lines and drains to tighten the tubes closed to flow without cutting, twisting, or otherwise damaging the tubes. The slotted openings in the linear adjuster 167 allow this

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113 Fine positioning and securing the occluder 147 in place. An overlapping release device, such as that provided by the release blade 169, is optionally located between the spring plates 165 and, as described in more detail below, can be rotated to push the spring plates 165 apart, thereby withdrawing the forceps head 161 towards the forceps head guide 163. The release blade 169 can be operated manually, e.g., to disable the occluder 147 in the event of loss of power, bladder failure 166 or other circumstances.

Additional configurations and descriptions of certain components that may be instructive in the construction of certain occluder modalities are provided in U.S. Patent No. 6,302,653. Spring plates 165 can be constructed of any material that is elastically resistant to bending forces and has sufficient longitudinal stiffness (bend strength) to provide sufficient restoring force, in response to bend displacement, to occlude a desired number of crushable tubes. In the illustrated embodiment, each spring plate is essentially flat when not under tension and is in the form of a sheet or plate. In alternative modalities that utilize one or more elastic occlusal members (spring members), any occlusal member(s) that are elastically resistant to bending forces and have sufficient longitudinal stiffness (bend strength) to provide sufficient restorative force in response to a bend displacement to occlude a desired number of squeezable tubes can be

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114 Use. Potentially suitable spring members can have a wide variety of shapes as is evident to those skilled in the art, including, but not limited to, cylindrical, prism-shaped, trapezoidal, square or rectangular bars or beams, I-beams, elliptical beams, bowl-shaped surfaces, and others. Experts in the art can easily select appropriate materials and dimensions for spring plates 165 based on the present teachings and the requirements of a particular application.

Figure 40 shows a top view of the occluder 147 with the bladder 166 deflated and the spring plates 165 positioned close together and in a flat or nearly flat condition. In this position, the clamp head 161 is fully extended from a clamp head guide and the cycler front panel 14 (i.e., the panel inside the door 141) and enabled to occlude the patient and drain lines. Figure 41, on the other hand, shows the bladder 166 in an inflated state in which the spring plates 165 are pushed apart, thereby retracting the gripper head 161 into the gripper head guide 163 (note that the line adjuster 167 is fixed in place relative to the cycler housing 82 and therefore fixed relative to the front panel of the housing 82). As the spring plates 165 move apart, the gripper head 161 moves backward relative to the front panel (since the gripper head 161 is arranged to move freely in and out of the gripper head guide 163). This condition prevents the head

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115

IMPH clamp 161 occludes the patient's drainage lines and is the condition in which occluder 147 remains during normal operation of cycler 14. That is, as described above, several components of cycler 14 can operate using air pressure/vacuum, e.g., control surface 148 can operate under the impulse of air pressure/vacuum to cause fluid pumping and valve operation for cassette 24. Therefore, when cycler 14 is operating normally, cycler 14 can produce sufficient air pressure to not only control the operation of the system, but also to inflate bladder 166 to retract clamp head 161 and prevent occlusion of the lines of the drained patient. However, in the event of system shutdown, failure, defect or other condition, the air pressure of the bladder 166 can be determined, causing the bladder 166 to deflate and the spring plates 165 to straighten and extend the clamp head 161 to occlude the lines. One possible advantage of the arrangement shown is that the return force of the spring plates 165 is balanced in such a way that the gripper head 161 will generally not engage in the gripper head guide 163 when moving relative to the gripper head guide 163. In addition, the opposing forces of the spring plates 165 will tend to reduce the amount of asymmetric friction wear of the pivot shafts and bushings of the assembly. Also, once the spring plates 165 are in an approximately straight position, the spring plates 165 can exert a force in a direction that generally along the length of the clamp head 161 that is several times greater than the force exerted

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116 by the bladder 166 over the spring plates 165 to separate the spring plates 165 from each other and retract the clamp head 161. Furthermore, when the spring plates 165 are in a flat or nearly flat condition, the force required to be exerted by the fluid in the flattened tube to overcome the clamping force exerted by the clamp head 161 reaches a relatively high required force, when applied to the spring plates at their ends and essentially parallel to the plane of the flattened spring plates, to buckle the spring plates when the column stability of the flattened spring plates breaks down. As a result, the occluder 147 can be very effective at occluding the lines with a reduced probability of failure while also requiring a relatively small force to be applied by the bladder 166 to retract the clamp head 161. The double spring plate arrangement of the illustrative modality may have the additional advantage of significantly increasing the gripping force provided by the gripper head, for any given die required to bend the spring plate and/or for any given size and thickness of the spring plate.

In some circumstances, the force exerted by the occluder 147 on the lines can be relatively large and may make the door 141 difficult to open. That is, the door 141 must resist the force of the occluder 147 when the clamp head 161 is in contact with and occludes the lines, and in some cases this may make the locking mechanism that holds the door 141 in a closed state difficult or impossible to operate manually. Of course, if cycler 14 is started and produces air pressure to operate, the

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117 The bladder of occluder 166 can be inflated and the clamp head of occluder 161 can be retracted. However, in some cases, such as with a pump failure in cycler 14, inflation of bladder 166 may be impossible or difficult. To allow the door to be opened, occluder 147 may include a manual release. In this illustrative embodiment, the occluder 147 may include a release blade 169 as shown in Figures 38 and 39, which includes a pair of pivotally mounted wings for rotary movement between the spring plates 165. When at rest, the release blade wings can be aligned with the springs as shown in Figure 39, allowing the occluder to operate normally. However, if the spring plates 165 are in a flat condition and the gripper head 161 needs to be manually retracted, the release blade 169 can be rotated, e.g., by hooking a hex key or other tool with the release blade 169 and rotating the release blade 169, so that the wings push the spring plates 165 apart. The hex key or other tool can be inserted through an opening in the cycler housing 82, e.g., an opening near the left-side handle depression in the cycler housing 82 and operated to disengage the occluder 147 and allow the door 141 to be opened.

Pump volume delivery measurement

In another aspect of the invention, the cycler 14 can determine a volume of fluid supplied in various lines of system 10 without the use of

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118 from a flow meter, scale, or other direct measurement of fluid volume or weight. For example, in one modality, a volume of fluid moved by a pump, such as a pump in cassette 24, can be determined based on pressure measurements of a gas used to drive the pump. In one modality, a volume determination can be made by isolating two chambers from each other, measuring the respective pressures in the isolated chambers, allowing the pressures in the chambers to partially equalize (by fluid connection of the two chambers) and measuring the pressures. Using the measured pressures, the known volume of one of the chambers, and an assumption that equalization occurs adiabatically, the volume of the other chamber (e.g., a pump chamber) can be calculated. In one embodiment, the pressures measured after the chambers are fluidly connected may be substantially unequal to each other; that is, the pressures in the chambers may not have been completely equalized. However, these substantially unequal pressures can be used to determine a pump control chamber volume, as explained below.

For example, Figure 42 shows a schematic view of a pump chamber 181 of the cassette 24 and associated control components and inlet/outlet flow paths. In this illustrative example, a liquid supply, which may include the heater bag 22, heater bag line 26, and a flow path through the cassette 24, is shown providing a liquid inlet at the top opening 191 of the

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119 pump chamber. The fluid outlet is shown in this example as receiving fluid from the lower opening 187 of the pump chamber 181, and may include a flow path from the cassette 24 and the patient line 34, for example. The fluid supply may include a valve, e.g., including valve port 192, which can be opened and closed to permit/prevent flow to or from the pump chamber 181. Similarly, the liquid outlet may include a valve, e.g., including valve port 190, which can be opened and closed to allow/prevent flow to or from pump chamber 181. Of course, the fluid supply could include any suitable arrangement, such as one or more solution containers, the patient line, one or more flow paths in the 24-cassette, or other fluid source, and the fluid outlet could also include any suitable arrangement, such as a drain line, the heater bag and heater bag line, one or more flow paths in the 24-cassette, or other fluid outlet. Generally speaking, the pump chamber 181 (i.e., on the left side of the diaphragm 14 in Figure 42) will be filled with a non-compressible liquid, such as water or dialysate, during operation. However, air or another gas may be present in the pump chamber 181 under certain circumstances, such as during initial operation, priming, or other situations as described later. It should also be understood that although aspects of the invention related to volume and/or pressure detection for the pump are described with reference to the pump arrangement of cassette 24, aspects of the

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120 The invention can be used with any suitable pump or fluid movement system.

Figure 42 also schematically shows to the right of the membrane 15 and the control surface 148 (which are adjacent to each other) a control chamber 171, which can be formed as a gap or other space in the matching block 170 associated with the pump control region 1482 of the control surface 148 for the pump chamber 181, as described above. It is in the control chamber 171 that the appropriate air pressure is introduced to cause the diaphragm 15/control region 1482 to move and pump liquid into the pump chamber 181. The control chamber 171 can communicate with a line LO which branches to another line L1 and a first valve X1 which communicates with a pressure source (e.g., an air or vacuum pressure source). The pressure source may include a piston pump in which the piston is moved in a chamber to control a pressure supplied to the control chamber 171, or it may include a different type of pressure pump and/or tank(s) to supply gas pressure suitable to move the diaphragm 15/control region 1482 and perform pumping action. The LO line also leads to a second valve X2, which connects to another line L2 and a reference chamber (e.g., a space suitably configured for performing the measurements described below). The reference chamber also connects to a line L3, which has a valve X3 that leads to a vent or other reference pressure (e.g., an atmospheric pressure source or

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121 (another reference pressure). Each of the valves X1, X2, and X3 can be independently controlled. Pressure sensors can be arranged, e.g., one sensor in the control chamber 171 and another sensor in the reference chamber, to measure the pressure associated with the control chamber and the reference chamber. These pressure sensors can be positioned and operated to detect the pressure in a suitable manner. Pressure sensors can communicate with control system 16 for cycler 14 or another suitable processor to determine a volume supplied by the pump or other characteristics.

As mentioned before, the valves and other components of the pump system shown in Figure 42 can be controlled to measure pressures in the pump chamber 181, the liquid supply and/or liquid outlet, and/or to measure a volume of fluid supplied from the pump chamber 181 to the liquid supply or liquid outlet. With respect to volume measurements, one technique used to determine a volume of fluid supplied from pump chamber 181 is to compare the relative pressures in the control chamber 171 with those of the reference chamber in the two different pump states. By comparing the relative pressures, a change in volume in the control chamber 171 can be determined, which corresponds to a change in volume in the pump chamber 181 and reflects a volume supplied from/received in the pump chamber 181. For example, after the pressure is reduced in the control chamber 171 during a pump chamber filling cycle (e.g., at

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122 Apply negative pressure from the pressure source through the open valve X1) to bring the diaphragm 15 and pump control region 1482 into contact with at least a portion of the control chamber wall (or another position suitable for the diaphragm 15/region 1482), valve X1 can be closed to isolate the control chamber from the pressure source, and valve X2 can be closed thereby isolating the reference chamber from the control chamber 171. Valve X3 can be opened to vent the reference chamber to ambient pressure, then closed to isolate the reference chamber. With valve X1 closed and the pressures in the control and reference chambers measured, valve X2 is then opened to allow the pressures in the control and reference chambers to begin equalizing. The initial pressures of the reference chamber and the control chamber, together with the known volume of the reference chamber and pressures measured after equalization has started (but not necessarily completed yet) can be used to determine a volume for the control chamber. This process can be repeated at the end of the pump supply cycle when the leaf 15/control region 1482 is pushed into contact with the separator elements 50 of the pump chamber 181. By comparing the control chamber volume at the end of the filling cycle with the volume at the end of the supply cycle, a volume of liquid supplied from the pump can be determined.

Conceptually, the pressure equalization process (e.g., at the opening of valve X2) is seen as occurring in an adiabatic manner;

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123

<img file="MX428429B_D0003.tif" />

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Given the assumption that an adiabatic system exists between the state when valve X2 is closed and after valve X2 is open and the pressure equalizes, the following applies:

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PV· = Constant (1)

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124 where P is pressure, V is volume, and γ is equal to a constant (e.g., approximately 1.4 where the gas is diatomic, such as air). Therefore, the following equation can be written to relate the pressures and volumes in the control chamber and the reference chamber before and after the opening of valve X2 and pressure equalization occur:

PrVr + PdVd⁷ = Constant = PfVf (2) where Pr is the pressure in the reference chambers and lines L2 and L3 before the opening of valve X2, Vr is the volume of the reference chamber and lines L2 and L3 before the opening of valve X2, Pd is the pressure in the control chamber and lines LO and L1 before the opening of valve X2, Vd is the volume of the control chamber and lines LO and L1 before the opening of valve X2, Pf is the equalized pressure in the reference chamber and the control chamber after the opening of valve X2, and Vf is the volume of the entire system including the control chamber, the reference chamber and the lines LO, L1, L2, and L3, i.e., Vf = Vd + Vr. Since Pr, Vr, Pd, Pf and γ are known and Vf = Vr + Vd, this equation can be used to solve for Vd. (Although reference is made herein, including in the claims, to the use of a “measured pressure” in determining volume values, etc., it may be understood that said measured pressure value is not necessarily of any particular form, such as in units of kg/cm²²Instead, a “measured pressure” or “determined pressure” may include a value that is representative of a pressure, such as

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125 such as a voltage level, a resistance value, a multibit digital number, etc. For example, a pressure transducer used to measure pressure in the pump control chamber may produce an analog voltage level, resistance, or other indication that is representative of the pressure in the pump control chamber. The empirical output of the transducer can be used as a measured pressure and/or some modified form of the output, such as a digital number generated using an analog output of the transducer, kg/cm².²or another value that is generated based on the transducer output, etc. The same is true of other values, such as a given volume, which is not necessarily in a particular form such as cubic centimeters. Rather, a given value can include any value that is representative of the volume, e.g., it could be used to generate an actual volume in, say, cubic centimeters.

In one modality of a fluid handling system (FMS) technique for determining the volume delivered by the pump, it is assumed that pressure equalization upon opening of valve X2 occurs in an adiabatic system. Therefore, equation 3 below gives the ratio of the reference chamber system volume before and after pressure equalization:

Vrf = Vri (Pf/Patm) (3) where Vrf is the final (post-equalization) volume of the reference chamber system which includes the reference chamber volume, the volume of lines L2 and L3 and the volume adjustment resulting from

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126 piston movement, which can be moved to the left or right of valve X2 after opening, Vri is the initial (pre-equalization) volume of the reference chamber and lines L2 and L3 with the piston located in valve X2, Pf is the final equalized pressure after valve X2 is opened, and Patm is the initial pressure of the reference chamber before the opening of valve X2 (in this example, atmospheric pressure). Similarly, equation 4 gives the ratio of the control chamber system volume before and after pressure equalization:

Vdf= Vdi (Pf/Pdi) (4) where Vdf is the final volume of the control chamber system which includes the volume of the control chamber, the volume of the LO and L1 lines, and the volume adjustment resulting from movement of the piston, which can be moved to the left or right of valve X2 after opening, Vdi is the initial volume of the control chamber and the LO and L1 lines with the piston located in valve X2, Pf is the final pressure after valve X2 is opened, and Pdi is the initial pressure of the control chamber before the opening of valve X2.

The volumes of the reference chamber system and the control chamber system will change by the same absolute amount after valve X2 is opened and the pressure equalizes, but will differ in sign (e.g., because the change in volume is caused by piston movement to the left or right when valve X2 opens), as shown in equation 5:

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127

ÁVr=(-1)ÁVd (5) (Note that this change in volume for the reference chamber and the control chamber is due solely to the movement of the imaginary piston. The reference chamber and the control chamber will not actually change in volume during the equalization process under normal conditions.) Also, using the relationship in equation 3, the change in volume of the reference chamber system is given by:

AVr = Vrf - Vri = Vri (-1 +(Pf/Patm) -&lt;^1/© (6)

Similarly, using equation 4, the change in volume of the control chamber system is given by:

ÁVd = Vdf - Vdi = Vdi (-1 +(Pf/Pdi) -&lt;^1/© (7)

Because Vri is known and Pf and Patm are measured or known, ÁVr can be calculated, which according to equation 5 is assumed to be equal to (-)AVd. Therefore, Vdi (the volume of the control chamber system before pressure equalization with the reference chamber) can be calculated using equation 7. In this mode, Vdi represents the volume of the control chamber plus lines LO and L1, of which LO and L1 are fixed and known quantities. Subtracting L0 and L1 from Vd1 yields the volume of the control chamber alone. Using equation 7 above, for example, both before (Vd1) and after (Vd2) a pump operation (e.g., at the end of the filling cycle and at the end of the unloading cycle), the change in control chamber volume can be determined, thus providing a measurement of the fluid delivery volume.

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128 by (or taken by) the pump. For example, if Vdi 1 is the volume of the control chamber at the end of the filling stroke, and Vd¡2 is the volume of the control chamber at the end of the subsequent delivery stroke, the volume of fluid delivered by the pump can be estimated by subtracting Vd¡1 from Vd¡2. Since this measurement is pressure-based, the volume determination can be made for almost any position of the diaphragm 15/pump control region 1482 in the pump chamber 181, whether for a full or partial pump stroke. However, the measurement taken at the end of the filling and delivery strokes can be achieved with little or no impact on pump operation and/or flow rate.

One aspect of the invention involves a technique for identifying pressure determination values ​​to be used in determining a volume for the control chamber and/or other purposes. For example, although pressure sensors can be used to detect a pressure in the control chamber and a pressure in the reference chamber, the detected pressure values ​​may vary with the opening/closing of valves, the introduction of pressure into the control chamber, the venting of the reference chamber to atmospheric pressure or another reference pressure, etc. Also, since in one mode, an adiabatic system is assumed to exist from a time before pressure equalization between the control chamber and the reference chamber until after equalization, identifying appropriate pressure values ​​that were measured so close in time can help reduce error (e.g., due to a shorter elapsed time).

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129 Pressure measurements can reduce the amount of heat exchanged in the system. Therefore, the measured pressure values ​​may need to be carefully chosen to help ensure that appropriate pressures are used to determine the volume delivered by the pump, etc.

For explanatory purposes, Figure 43 shows a graph of illustrative pressure values ​​for the control chamber and the reference chamber from a point in time before the opening of valve X2 to some time after valve X2 is opened to allow the pressure in the chambers to equalize. In this illustrative mode, the pressure in the control chamber is higher than the pressure in the reference chamber before equalization, but it should be understood that the pressure in the control chamber may be lower than the pressure in the reference chamber before equalization in some arrangements, such as during and/or at the end of a filling stroke. Also, the graph in Figure 43 shows a horizontal line marking the equalization pressure, but it should be understood that this line is shown for clarity only. The equalization pressure will generally not be known before valve X2 opens. In this mode, the pressure sensors detect pressure at a rate of approximately 200 Hz for both the control and reference chambers, although appropriate sampling rates could be used. Before valve X2 opens, the pressures in the control chamber and the reference chamber are approximately constant, with no air present.

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130 Another fluid may be introduced into the chambers. Therefore, valves X1 and X3 will generally be closed some time before valve X2 opens. Also, valves leading to the pump chamber, such as valve ports 190 and 192, may be closed to prevent pressure variations from affecting the pump chamber, the fluid supply, or the fluid outlet.

First, the measured pressure data are processed to identify the initial pressures for the control chamber and the reference chambers, i.e., Pd and Pr. In an illustrative mode, the initial pressures are identified based on analysis of a 10-point sliding window used on the measured pressure data. This analysis involves generating a best-fit line for the data in each window (or set), e.g., using a least-squares technique, and determining a slope for the best-fit line. For example, each time a new pressure is measured for the control chamber or the reference chamber, a least-squares fit line can be determined for a data set that includes the latest measurement and the nine previous pressure measurements. This process can be repeated for several pressure datasets, and a determination can be made as to when the slope of the least-squares fit lines first becomes negative (or otherwise non-zero) and continues to grow more negative for subsequent datasets (or otherwise deviates from a zero slope). The point at which the least-squares fit lines

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131 The squares begin to have a suitable non-zero slope and in increments can be used to identify the initial pressure of the chambers, that is, at a time before valve X2 opens.

In one modality, the initial pressure value for the reference chamber and the control chamber can be determined to be in the last of 5 consecutive data sets, where the slope of the best-fit line for the data sets increases from the first data set to the fifth data set, and the slope of the best-fit line for the first data set first becomes non-zero (i.e., the slope of the best-fit lines for datasets preceding the first dataset is zero or otherwise not sufficiently different from zero). For example, the pressure sensor may take samples every¹Z> millisecond (or other sampling rate) starting at a time before valve X2 opens. Each time a pressure measurement is taken, cycler 14 can take the most recent measurement along with the 9 previous measurements and generate a better line of fit to the 10 data points in the set. When taking the next pressure measurement (e.g.,¹Z> millisecond later), cycler 14 can take the measurement along with the previous 9 measurements, and again generates a best-fit line to the 10 points in the set. This process can be repeated, and cycler 14 can be determined when the slope of the best-fit line for a set of 10 data points first becomes non-zero (or otherwise suitably steep) and, for example,

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132 that the slope of the best-fit line for 5 subsequent sets of 10 data points increases with each subsequent data set. To identify the specific pressure measurement to use, one technique is to select the third measurement in the 5^either data set (i.e., the 5^eitherdataset with which it was found that the best fit line has been consistently increasing in slope and the 1^to The pressure measurement taken previously at time) is to be used as the initial pressure for the control chamber or reference chamber, i.e., Pd or Pr. This selection was made using empirical methods, e.g., by plotting the pressure measurement values ​​and then selecting which point best represents the time when the pressure begins the equalization process. Of course, other techniques could be used to select the appropriate initial pressure.

In an illustrative way, one can verify that the times at which the selected Pd and Pr measurements occurred are within the desired time threshold, e.g., within 1-2 milliseconds of each other. For example, if the technique described above is used to analyze the control chamber pressure and the reference chamber pressure and to identify a pressure measurement (and therefore a point in time) just before pressure equalization begins, the times at which the pressures were measured must be relatively close to each other. Otherwise, there may be an error or other fault condition that invalidates one or both of the pressure measurements. Upon confirming that the time

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133 in which Pd and Pr occurred are adequately close, cycler 14 can confirm that the initial pressures were appropriately identified.

To identify when the pressures in the control chamber and the reference chamber have equaled, the cycler 14 can analyze data sets that include a series of data points from pressure measurements for both the control and reference chambers, determine a best-fit line for each of the data sets (e.g., using a least squares method) and identify when the slopes of the best-fit lines for a control chamber data set and a reference chamber data set are first adequately similar to each other, e.g., the slopes are both close to zero or have values ​​that are within a threshold of each other. When the slopes of the best-fit lines are similar or close to zero, the pressure can be determined to be equalized. The first pressure measurement for any data set can be used as the final equalized pressure, i.e., Pf. In an illustrative example, pressure equalization was found to generally occur within approximately 200–400 milliseconds after valve X2 is opened, with the bulk of equalization occurring within approximately 50 milliseconds. Consequently, the pressure in the control and reference chambers can be

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134 Master approximately 400-800 times or more during the entire equalization process from a time before valve X2 opens until a time when equalization has been achieved.

In some cases, it may be desirable to increase the accuracy of the control chamber volume measurement using an alternative FMS technique. Substantial temperature differences between the pumped liquid, the control chamber gas, and the reference chamber gas can introduce significant errors in calculations based on the assumption that pressure equalization occurs adiabatically. Waiting to take pressure measurements until complete equalization between the control and reference chambers can allow excessive heat transfer to occur. In one aspect of the invention, pressure values ​​for the pump chamber and the reference chamber that are substantially equal to each other—that is, measured before complete equalization has occurred—can be used to determine the volume of the pump chamber.

In one mode, heat transfer can be minimized, and the adiabatic calculation error reduced, by measuring chamber pressures throughout the equalization period from the opening of valve X2 through full pressure equalization, and selecting a sampling point during the equalization period for the adiabatic calculations. In one mode of an APD system, the measured chamber pressures are taken before completing the

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135 Pressure equalization between the control chamber and the reference chamber can be used to determine the pump chamber volume. In one mode, these pressure values ​​can be measured approximately 50 ms after the chambers are first fluidly connected and equalization is initiated. As mentioned earlier, in one mode, complete equalization can occur approximately 200–400 ms after valve X2 is opened. Therefore, the measured pressures can be taken at a point in time after valve X2 is opened (or equalization is initiated), i.e., approximately 10% to 50% or less of the total equalization period. Alternatively, the measured pressures can be taken at a point in time at which 50-70% pressure equalization has occurred (i.e., the reference chamber and pump pressures have changed by approximately 50-70% of the difference between the initial chamber pressure and the final equalized pressure). Using a computer-enabled controller, a substantial number of pressure measurements in the control and reference chambers can be made, stored, and analyzed during the equalization period (e.g., 40-100 individual pressure measurements). Among the time points sampled during the first 50 ms of the equalization period, there is a sampling point theoretically optimized for conducting adiabatic calculations (e.g., see Figure 43, where the optimized sampling point occurs approximately 50 ms after valve X2 opens). The optimized sampling point can occur at a sufficiently early time.

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136 after the opening of valve X2 to minimize heat transfer between the gas volumes of the two chambers, but not so early as to introduce significant errors in pressure measurements due to the properties of the pressure sensors and delays in valve actuation. However, as can be seen in Figure 43, the pressures for the pump chamber and reference chambers may be substantially unequal to each other at that point, and therefore equalization may not be complete. (Note that in some cases, it may be technically difficult to take reliable pressure measurements immediately after valve X2 is opened, for example, due to the inherent inaccuracies of the pressure sensors, the time required for valve X2 to fully open, and the rapid initial change in pressure in either the control chamber or the reference chamber immediately after valve X2 is opened.)

During pressure equalization, when the final pressure for the control chamber and reference chambers is not the same, equation 2 becomes:

PriVrl· + PdiVdi⁷ = Constant = PrfVrfr + PdfVdf (8) where: Pri = pressure in the reference chamber before the opening of valve X2, Pdi = pressure in the control chamber before the opening of valve X2, Prf = final reference chamber pressure, Pdf = final control chamber pressure.

An optimization algorithm can be used to select a

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137

IMPIg is the point in time during the pressure equalization period at which the difference between the absolute values ​​of AVd and AVr is reduced to a minimum (or below a desired threshold) over the equalization period. (In an adiabatic process, the difference should ideally be zero, as indicated by equation 5.) In Figure 43, the point in time at which the difference between the absolute values ​​of AVd and AVr is minimized occurs on the 50ms line, labeled “time at which final pressures were identified.” First, pressure data can be collected from the control and reference chambers as multiple points j = 1 through n between the opening of valve X2 and final pressure equalization. Since Vri, the fixed volume of the reference chamber system before pressure equalization, is known, a subsequent value for Vrj (volume of reference chamber system at point j after valve X2 has opened) can be calculated using equation 3 at each sample point Prj along the equalization curve. For each value of Vrj, a value for AVd can be calculated using equations 5 and 7. Each value of Vrj therefore yields Vdij, a putative value for Vdi, the value of the control chamber system before pressure equalization. Using each value of Vrj and its corresponding value of Vdij, and using equations 3 and 4, the difference in the absolute values ​​of AVd and AVr can be calculated at each

MX/a/2021/007240 pressure measurement point along the equalization curve. The sum of these squared differences provides a measurement of the error in the calculated value of Vdi during pressure equalization for each value of Vrj and its

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138

corresponding Vdij. Denoting the reference chamber pressure that produces the minimum sum of the squared differences of |AVd| and |AVr| as Prf, and its associated reference chamber volume as Vrf, the Prf and Pdf data points corresponding to Vrf can be used to calculate an optimized estimate of Vdi, the initial volume of the control chamber system.

One method for determining where on the equalization curve to capture an optimized value for Pdf and Prf is as follows:

1) Acquire a series of pressure data sets from the control and reference chambers, starting immediately before the opening of valve X2 and ending with Pr and Pd becoming nearly equal. If Pri is the first reference chamber pressure captured, then subsequent sampling points in Figure 32 will be referred to as Prj = Pr1, Pr2,...Prn.

2) Using equation 6, for each Prj after Pri, the corresponding AVrj is calculated where j represents the j-th pressure data point after Pri.

AVrj = Vrj - Vri = Vri (-1 +(Prj/Pri) -&lt;^1/^

3) For each AVrj, the corresponding Vdij is calculated using equation 7. For example:

AVr1 = Vri * (-1 + (Prl/Pri)

AVd1 = -AVr1

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Therefore,

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139

Vd¡1 = AVd1 / (-1 +(Pd1/Pdi) -&lt;^1/^)

Vdin = AVdn / (-1 +(Pdn/Pd¡) -&lt;^1/^)

Having calculated a set of n initial control chamber system volumes (Vd1 to Vdin) based on the set of reference chamber pressure data points Pr1 to Prn during pressure equalization, it is now possible to select the point in time (f) that produces an optimized measurement of the initial control chamber system volume (Vdi) over the entire pressure equalization period

4) Using equation 7, for each Vd¡1 through Vdin, calculate all AVdj,k using control chamber pressure measurements Pd for points at time k = 1 to n.

For the Vdi corresponding to Pr1:

ÁVd1, 1 = Vd¡1 * (-1 + (Pd1/Pdi) <^1/^>)

AVd1,2 = Vd¡1 * (-1 + (Pd2/Pdi)-<^1/y>)

ÁVd1,n = Vd¡1 * (-1 + (Pdn/Pdi) -<^1/?>)

For the Vdi corresponding to Prn:

AVdn,1 = Vdin * (-1 + (Pd1/Pdi) -&lt;^1/^)

AVdn,2 = Vdin * (-1 + (Pd2/Pdi) -<^1/?>)

AVdn,n = Vdin * (-1 + (Pdn/Pdi) -&lt;^1/^)

5) Take the error of the square of the sum between absolute values ​​of AVr's and AVdj.k's

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<img file="MX428429B_D0004.tif" />

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INDUSTRIAL (0 n

Si = Σ í |AV_dljk| - [AV_r]1])²k=t

[S1 represents the error of the square of the sum of |AVd| minus |AVr| over all data points during the equalization period when the first data point Pr1 is used to determine Vdi, the initial volume of the control chamber system, from Vr1 and AVr.] n

3ι = Σ( |AV^|- |4V_fi|)²k=l

[S2 represents the error of the square of the sum of |ÁVr| minus |AVd| over all data points during the equalization period when the second data point Pr2 is used to determine Vdi, the initial volume of the control chamber system, from Vr2 and ÁVr.] n k-1

6) The data point of Pr between Pr1 and Prn that generates the minimum sum-squares error of step 5 (or a value that is below a desired threshold) then becomes the chosen Prf, from which Pdf and an optimized estimate of Vdi, the initial control chamber volume, can then be determined. In this example, Pdf occurs at, or approximately at, the same time as Prf.

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7) The above procedure can be applied at any time an estimate of the control chamber volume is desired, but preferably it can be applied at the end of each filling stroke and each

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141 Delivery stroke. The difference between the optimized Vd¡ at the end of a filling stroke and the optimized Vd¡ at the end of a corresponding delivery stroke can be used to estimate the volume of liquid delivered by the pump.

Air detection

Another aspect of the invention involves determining the presence of air in the pump chamber 181, and if present, the volume of air present. Such a determination may be important, e.g., to help ensure that a priming sequence is properly performed to remove air from the cassette 24 and/or to help ensure that air is not delivered to the patient. In certain modalities, for example, when fluid is supplied to the patient through the lower opening 187 at the bottom of the pump chamber 181, air or other gas that is trapped in the pump chamber may tend to remain in the pump chamber 181 and will be inhibited from being pumped to the patient unless the volume of the gas is larger than the effective dead space volume of the pump chamber 181. As described below, the volume of air or other gas contained in the pump chambers 181 can be determined in accordance with aspects of the present invention and the gas can be purged from the pump chamber 181 before the volume of the gas is greater than the effective dead space volume of the pump chamber 181.

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142

A determination of the amount of air in pump chamber 181 can be made at the end of a filling stroke, and therefore, can be performed without interrupting a pumping process. For example, at the end of a filling stroke during which the diaphragm 15 and the pump control region 1482 are moved away from the cassette 24 in such a way that the diaphragm 15/region 1482 are brought into contact with the wall of the control chamber 171, the valve X2 can be closed, and the reference chamber vented to atmospheric pressure, e.g., by opening the valve X3. Subsequently, valves X1 and X3 can be closed, fixing the imaginary “piston” in the valve reference chamber to equalize, as described earlier, pressure measurements are taken to determine a volume for the control chamber.

If there is no air bubble in pump chamber 181, the change in volume of the reference chamber, i.e., due to the movement of the imaginary “piston”, determined using the known initial volume of the reference chamber system and the initial pressure in the reference chamber, will be equal to the change in volume of the control chamber determined using the known initial volume of the control chamber system and the initial pressure in the control chamber. (The initial volume of the control chamber can be known under conditions where the membrane 15/control region 1482 is in contact with the wall of the control chamber or in contact with the separating elements 50 of the pump chamber 181). However, if air is present in the pump chamber 181,

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143 The change in volume of the control chamber will actually be distributed between the volume of the control chamber and the air bubble(s) in pump chamber 181. As a result, the calculated change in volume for the control chamber using the known initial volume of the control chamber system will not be equal to the calculated change in volume for the reference chamber, thus signaling the presence of air in the pump chamber.

If there is air in pump chamber 181, the initial volume of the control chamber system Vdi is actually equal to the sum of the volume of the control chamber and lines LO and L1 (referred to as Vdfix) plus the initial volume of the air bubble in pump chamber 181 (referred to as Vbi), as shown in equation 9:

Vdi = Vbi + Vdfix (9)

With the membrane 15/control region 1482 pressed against the wall of the control chamber at the end of a filling stroke, the volume of any air space in the control chamber, e.g., due to the presence of grooves or other features in the wall of the control chamber, and the volume of the LO and L1 lines - together with Vdfix - can be determined very accurately. (Similarly, with the membrane 15/control region pressed against the separator elements 50 of the pump chamber 181, the control chamber volume and the LO and L1 lines can be accurately determined.) After a filling stroke, the control chamber system volume is tested using a positive control chamber pre-charge. Any discrepancy between this tested volume and the actual volume

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144 A reading taken at the end of the filling stroke can indicate the volume of air present in the pump chamber. Substituting from equation 9 into equation

7, the change in volume of the AVd control camera is given by:

AVd = (Vbi +Vdfix)(-1 +(Pdf/Pdi)(10)

Since AVr can be calculated from equation 6, and we know from equation 5 that AVr = (-1) AVd, equation 10 can be rewritten as:

(- 1) AVr = (Vbi +Vdfix)(-1 +(Pdf/Pdi) &lt;^1/^(11) and again as

Vbi = (-1) AVr /(-1 +(Pdf/Pdi) -&lt;¹^) - Vdfix (12)

Therefore, cycler 14 can determine if there is air in pump chamber 181, and the approximate volume of the bubble using equation 12. This calculation of the air bubble volume can be performed if it is found that, for example, the absolute values ​​of AVr (as determined from equation 6) and AVd (as determined from equation 7 using Vdi = Vdfix) are not equal to each other. That is, Vdi must be equal to Vdfix if there is no air present in pump chamber 181, and therefore the absolute value for AVd given by equation 7 using Vdfix instead

MX/a/2021/007240 of Vdi will be equal to AVr.

After a filling stroke has been completed, and if air is detected in accordance with the methods described above, it can be difficult to determine whether the air is located on the side of the chamber of

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145 Pump or control side of diaphragm 15. Air bubbles may be present in the liquid being pumped, or there may be residual air on the control (pneumatic) side of pump diaphragm 15 due to a condition (such as, for example, an occlusion) during pumping that caused an incomplete pump stroke and incomplete filling of the pump chamber. At this point, an adiabatic FMS measurement using a negative pump chamber precharge can be performed. If this FMS volume matches the FMS volume with the positive preload, then the membrane is free to move in both directions, implying that the pump chamber is only partially filled (possibly, for example, to an occlusion). If the negative FMS precharge volume value of the pump chamber equals the nominal control chamber air volume when the 15/region 1482 membrane is in contact with the inner wall of the control chamber, then it is possible to conclude that there is an air bubble in the liquid on the pump chamber side of the flexible membrane.

Head height detection

In some circumstances, it can be helpful to determine the patient's height relative to cassette 24 or another part of the system. For example, dialysis patients may sometimes feel a "jerk" or other movement due to fluid flowing into or out of the patient's peritoneal cavity during a filling or draining operation. To reduce this sensation, the cycler 14

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146 It can reduce the pressure applied to patient line 34 during filling and/or draining operations. However, to properly set the pressure for patient line 34, the cycler 14 can determine the patient's height relative to the cycler 14, the heater bag 22, the drain, or another part of the system. For example, when performing a filling operation, if the patient's peritoneal cavity is located 1.52 m above heater bag 22 in cassette 24, the cycler 14 may need to use a higher pressure in the patient line 34 to deliver dialysate than if the patient's peritoneal cavity is located 1.52 m below cycler 14. The pressure can be adjusted, for example, by alternately opening and closing a binary pneumatic source valve for varying time intervals to achieve the desired target pump chamber pressure. An average desired target pressure can be maintained, for example, by adjusting the time intervals to keep the valve open when the pump chamber pressure is below the target pressure by a specified amount, and to keep the valve closed when the pump chamber pressure is above the target pressure by a specified amount. Any adjustments necessary to maintain a full stroke volume can be made by adjusting the pump chamber filling and/or delivery times. If a variable orifice fountain valve is used, the target pump chamber pressure can be achieved by varying the orifice of the fountain valve in addition to regulating the timing of the intervals during which the valve is open and closed.

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147 closed. To adjust for the patient's position, the cycler 14 can momentarily stop fluid pumping, leaving the patient line 34 in open fluid communication with one or more pump chambers 181 in the cassette (e.g., by opening suitable valve ports in the cassette 24). However, other fluid lines can be closed, such as the upper valve ports 192 for the pump chambers 181. In this condition, the pressure in the control chamber for one of the pumps can be measured. As is well known in the art, the pressure correlates with the patient's head height and can be used by cycler 14 to control the fluid delivery pressure to the patient. A similar approach can be used to determine the height of the “head” of the heater bag 22 (which will generally be known) and/or the solution containers 20, since the height of the head of these components can have an effect on the pressure required to pump fluid in a suitable manner.

Cycler noise reduction features

According to aspects of the invention, the cycler 14 may include one or more features for reducing noise generated by the cycler 14 during operation and/or when not in operation. In one aspect of the invention, the cycler 14 may include a single pump that generates both pressure and vacuum, which is used to control the various pneumatic systems of the cycler 14. In one embodiment, the pump may generate

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148 Simultaneously applying both pressure and vacuum reduces overall operating time and allows the pump to operate more slowly (and therefore more quietly). Alternatively, the start and/or stop of the air pump can be regulated, e.g., slowly increasing the pumping speed or power output at start and/or slowly decreasing the pumping speed or power output at stop. This arrangement can help reduce the "on/off" noise associated with starting and stopping the air pump, making the pump noise less noticeable. Alternatively, the air pump can be operated at a lower duty cycle when approaching a target pressure or output volume, allowing it to continue operating instead of shutting down, only to restart after a short time. As a result, the disturbance caused by repeated on/off cycles of the air pump can be avoided.

Figure 44 shows a perspective view of an interior section of the cycler 14 with the upper portion of the housing 82 removed. In this illustrative embodiment, the cycler 14 includes a single air pump 83, comprising the actual pump and motor impeller contained within a sound barrier housing. The sound barrier housing includes an outer protective enclosure, such as a metal or plastic frame, and sound-insulating material inside the outer enclosure, at least partially surrounding the motor and pump. This 83 air pump can simultaneously provide air pressure and vacuum, e.g., to a pair of

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149 Accumulator tanks 84. One of the tanks 84 can store positive pressure air, while the other stores vacuum. A suitable manifold and valve arrangement can be coupled to the tanks 84 to supply and control air/vacuum pressure supplied to the cycler components 14.

According to another aspect of the invention, components that require a relatively constant pressure or vacuum supply during cycler operation, such as an occluder, can be isolated from the air/vacuum pressure source for at least relatively long periods. For example, occluder 147 in cycler 14 generally requires constant air pressure in the bladder of occluder 166 so that the patient and drain lines remain open for flow. If cycler 14 continues to operate properly without power failure, etc., bladder 166 can be inflated once at the beginning of system operation and remain inflated until it is shut down. The inventors have acknowledged that under certain circumstances, relatively static air-powered devices such as the Bladder 166 may "creak" or otherwise make noise in response to slight variations in the supplied air pressure. Such variations can cause the Bladder 166 to change size slightly, which in turn causes associated mechanical parts to move and potentially make noise. In accordance with one aspect of the bladder 166 and other components having similar pneumatic power requirements, they can be isolated from the air pump 83 and/or the tanks

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150

84, e.g., when closing a valve, to reduce pressure variations in the bladder or other pneumatic component, thereby reducing the noise that may be generated as a result of pressure variations. Another component that can be isolated from the pneumatic supply is the bladder at the door 141 at the cassette mounting location 145, which inflates to press the cassette 24 against the control surface 148 when the door 141 is closed. Other suitable components can be isolated as desired.

In accordance with another aspect of the invention, the speed and/or force at which the pneumatic components are actuated can be controlled to reduce the noise generated by the operation of the component. For example, moving the valve control regions 181 to move a corresponding portion of the cassette diaphragm 15 to open or close a valve port in cassette 24 can cause a “clicking” noise as the diaphragm 15 hits against and/or pulls on cassette 24. This noise can be reduced by controlling the operating speed of the valve control regions 1481, e.g., by restricting the airflow rate used to move the control regions 1481. The airflow can be restricted, for example, by providing a suitably small orifice in the line leading to the associated control chamber, or in other ways.

A controller can also be programmed to apply pulse amplitude modulation (PWM) to the activation of one or more pneumatic source valves in a cycler manifold 14. The pressure

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151 Pneumatics supplied to various cassette valves and pumps 24 can be controlled by causing the associated manifold source valves to open and close repeatedly during the actuation period of a valve or pump in cassette 24. The rate of pressure rise or fall against the diaphragm 15/control surface 148 can be controlled by modulating the duration of the “on” portion of the particular manifold valve during the actuation period. An additional advantage of applying PWM to manifold source valves is that variable pneumatic pressure can be supplied to cassette 24 components using only a binary (on/off) source valve, rather than a more expensive and potentially less reliable variable orifice source valve.

According to another aspect of the invention, the movement of one or more valve elements can be adequately dampened to reduce the noise generated by valve cycling. For example, a fluid (such as a ferrofluid) can be supplied to the valve element of high-frequency solenoid valves to dampen the movement of the element and/or reduce the noise generated by the movement of the valve element between the open and closed portions.

According to another embodiment, pneumatic control line vents can be connected together and/or directed to a sound-isolated space so that the noise associated with the release of air pressure or vacuum can be reduced. For example, when the bladder of occluder 166 is vented to allow the spring plates 165 to move toward each other

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152 In other cases, if one or more lines are occluded, the released air pressure can be released into a soundproof enclosure, as opposed to being released into a space where the noise associated with the release might be more easily heard. Alternatively, lines designed to release air pressure can be connected to lines designed to release an air vacuum. With this connection (which may include a vent to the atmosphere, an accumulator, or other), the noise generated by the release of pressure/vacuum can be further reduced.

Control system

The control system 16 described in connection with Figure 1 has a number of functions, such as controlling dialysis therapy and communicating information related to dialysis therapy. Although these functions can be handled by a single computer or processor, it may be desirable to use different computers for different functions so that the implementations of those functions remain physically and conceptually separate. For example, it may be desirable to use one computer to control the dialysis machinery and another computer to control the user interface.

Figure 45 shows a block diagram illustrating an illustrative implementation of control system 16, wherein the control system comprises a computer that controls the dialysis machinery (an “automation computer” 300) and a separate computer that

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153 It controls the user interface (a “user interface computer” 302). As will be described, safety-critical system functions can be operated only on the automation computer 300, so that the user interface computer 302 is isolated from performing safety-critical functions.

The Automation Computer 300 controls the hardware, such as the valves, heaters, and pumps, that implement dialysis therapy. In addition, the Automation Computer 300 sequences the therapy and maintains a user interface "model," as further described here. As shown, the automation computer 300 comprises a computer processing unit (CPU)/memory 304, an instant disk file system 306, a network interface 308, and a hardware interface 310. The hardware interface 310 is coupled to sensors/actuators 312. This coupling enables the automation computer 300 to read the sensors and control the hardware actuators of the APD system to monitor and perform therapy operations. The 308 network interface provides an interface for coupling the 300 automation computer to the 302 user interface computer.

The 302 user interface computer controls the components that enable data exchange with the outside world, including external user devices and entities. The 302 user interface computer comprises a processing unit of

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154 computer (CPU)/memory 314, an instant disk file system 316, and a network interface 318, each of which may be the same as or similar to their counterparts on the automation computer 300. The Linux operating system may operate on each of the automation computer 300 and the user interface computer 302. An illustrative processor that may be suitable for use as the CPU of the Automation Computer 300 and/or for use as the CPU of the User Interface Computer 302 is Freescale's Power PC 5200B®.

Using network interface 318, user interface computer 302 can be connected to automation computer 300. Both automation computer 300 and user interface computer 302 can be housed within the same APD system chassis. Alternatively, one or both of these computers (e.g., display 324) can be located outside the chassis. The Automation Computer 300 and the User Interface Computer 302 can be coupled by a wide area network, a local area network, a bus structure, a wireless connection and/or some other means of data transfer.

The 318 network interface can also be used to connect the 302 user interface computer to the Internet 320 and/or other networks. Such a network connection can be used, for example, to initiate connections to a clinic or clinician, upload therapy data to a remote database server, obtain new prescriptions from a clinician,

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155 Update application software, obtain service support, request supplies, and/or export data for maintenance use. For example, call center technicians can remotely access alarm input and machine configuration information over the Internet via network interface 318. If desired, the 302 user interface computer can be configured so that connections can only be initiated by the user or otherwise locally by the system, and not by remote initiators.

The user interface computer 302 also comprises a graphics interface 322 that is coupled to a user interface, such as the user interface 144 described in connection with Figure 10. According to an illustrative implementation, the user interface comprises a display 324 that includes a liquid crystal display (LCD) and is associated with a touch screen. For example, a touchscreen can be placed over the LCD so that the user can provide input to the user interface computer 302 by touching the screen with a finger, stylus, or similar device. The screen can also be associated with an audio system capable of playing back, among other things, audio messages and recorded voices. The user can adjust the brightness of the screen 324 based on their environment and preference. Optionally, the APD system can include a light sensor and the brightness of the screen can be automatically adjusted in response to the amount of ambient light detected by the light sensor.

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156

In addition, the user interface computer 302 comprises a USB interface 326. A data storage device 328, such as a USB flash drive, can be selectively attached to the user interface computer 302 via the USB interface 326. The data storage device 328 can comprise a “patient data key” used to store patient-specific data. Dialysis therapy data and/or screening questions (e.g., weight, blood pressure) can be entered onto the patient data key. This allows the patient data to be accessed by the 302 user interface computer when it is connected to the 326 USB interface and by a portable device when it is disconnected. The patient data key can be used to transfer data from one system or cycler to another during a cycler exchange, transferring new therapy data and cycler settings from the clinical software to the system, and transferring treatment history and device history information from the system to the clinical software. An illustrative patient data key 325 is shown in Figure 65.

As shown, the patient data key 325 comprises a connector 327 and a housing 329 articulated to the connector. The patient data key 325 may optionally be associated with a dedicated USB port 331. The port 331 comprises a recess 333 (e.g., in the APD system chassis) and a connector 335 disposed within the recess. The recess may be defined, at least in part, by a housing 337.

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157 associated with port 331. The patient data key connector 327 and the port connector 335 are adapted to be selectively coupled electrically and mechanically to one another. As can be seen from Figure 65, when the patient data key connector 327 and the port connector 335 are coupled, the housing 329 of the patient data storage device 325 is received at least partially within the depression 333.

The slot 329 of patient data key 325 may include visual cues indicating the port with which it is associated and/or configured to prevent incorrect insertion. For example, the depression 333 and/or slot 337 of port 331 may have a shape corresponding to the shape of slot 329 of patient data key 325. For example, each may have a non-rectangular or otherwise irregular shape, such as an oblong shape with a top indentation as shown in Figure 65. The depression 333 and/or the housing 337 of port 331 and the housing 329 of patient data key 325 may provide additional visual cues to indicate their association. For example, each may be formed from the same material and/or have the same or similar color and/or pattern.

Alternatively or additionally, patient data key 325 may include a verification code readable by the APD system to verify that the patient data key is of an expected type and/or origin. This verification code may be stored in a

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158 The verification code is stored in the patient data key 325 memory and can be read from the patient data key and processed by an APD system processor. Alternatively or additionally, this verification code can be embedded on the outside of the patient data key 325, e.g., as a barcode or numeric code. In this case, the code can be read by a camera and associated processor, a barcode scanner, or another code-reading device.

If the patient data key is not inserted when the system is powered on, an alert may be generated requiring the key to be entered. However, the system may be able to operate without the patient data key, provided it has been previously configured. Therefore, a patient who has lost their patient data key can continue to receive therapy until a replacement key can be obtained. Data can be stored directly to the patient data key or transferred to the patient data key after being stored on the user interface computer 302. Data can also be transferred from the patient data key to the user interface computer 302.

In addition, a USB Bluetooth adapter (330) can be connected to the user interface computer (302) via the USB interface (326) to enable, for example, data exchange with Bluetooth-enabled devices. For instance, a Bluetooth-enabled scale in the vicinity of the APD system can transfer information.

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159 Wireless transmission of patient weight data to the system via the USB 316 interface using the USB 330 Bluetooth adapter. Similarly, a Bluetooth-enabled sphygmomanometer can wirelessly transmit patient blood pressure data to the system using the USB 330 Bluetooth adapter. The Bluetooth adapter can be integrated into the 302 user interface computer or it can be external (e.g., a Bluetooth hardware key).

The USB 326 interface can include multiple ports, and these ports can be in different physical locations and used for different USB devices. For example, it might be desirable to make the USB port for the patient data key accessible from the front of the machine, while another USB port could be provided on and accessible from the back of the machine. A USB port for Bluetooth connection can be included on the outside of the chassis, or rather it can be located inside the machine or inside the battery door, for example.

As noted earlier, functions that might have safety-critical information can be isolated on the automation computer. Safety-critical information refers to APD system operations. For example, safety-critical information might include the status of an APD procedure and/or the algorithms for implementing or monitoring therapies. Non-safety-critical information might include information related to the visual presentation of the

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160 screen that is not material for APD system operations.

By isolating functions that could have critical safety implications on the automation computer 300, the user interface computer 302 can be relieved of handling safety-critical operations. Therefore, problems with or changes to the software running on the user interface computer 302 will not affect the delivery of therapy to the patient. Consider the example of graphics libraries (e.g., Trolltech's Qt® toolkit), which can be used by the 302 user interface computer to reduce the amount of time required to develop the user interface view. Because these libraries are handled by a separate process and processor from those of the Automation Computer 300, the Automation Computer is protected from any defects in the libraries that could affect the rest of the system (including safety-critical functions) if they were handled by the same processor or process.

Of course, although the user interface computer 302 is responsible for presenting the interface to the user, data can also be entered by the user through the use of the user interface computer 302, e.g., through the display 324. To maintain isolation between the functions of the automation computer 300 and the user interface computer 302, the data received by the display 324 can be sent to the automation computer for interpretation and returned to the user interface computer.

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161 user for deployment.

Although Figure 45 shows two separate computers, the separation of the storage and/or execution of security-critical functions from the storage and/or execution of non-security-critical functions can be provided by having a single computer that includes separate processors, such as CPU/memory components 314 and 314. Therefore, it can be appreciated that the provision of separate processors or separate “computers” is not necessary. Furthermore, a single processor can alternatively be used to perform the functions described above. In this case, it may be desirable to functionally isolate the execution and/or storage of the software components that control the dialysis machinery from that which controls the user interface, although the invention is not limited in this respect.

Other aspects of the system architecture can also be designed to address security concerns. For example, the 300 automation computer and the 302 user interface computer can include a “secure line” that can be enabled or disabled by the CPU in each computer. The safe line can be connected to a voltage supply that generates a voltage (e.g., 12 V) sufficient to enable at least some of the APD system's 312 sensors/actuators. When both the automation computer CPU 30 and the user interface computer CPU 302 send an enable signal to the safe line, the voltage generated by the supply

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162 It can be transmitted to sensors/actions to activate and disable certain components. Voltage, for example, can activate the pneumatic valves and the pump, disable the occluder, and enable the heater. When the CPU stops sending the enable signal to the safe line, the voltage path can be interrupted (e.g., by a mechanical relay) to deactivate the pneumatic valves and the pump, enable the occluder, and deactivate the heater. In this way, when the automation computer 300 or the user interface computer 302 is deemed necessary, the patient can be quickly isolated from the fluid path, and other activities such as heating and pumping can be stopped. Each CPU can disable the safe line at any time, such as when a critical safety error is detected or a software monitor detects a fault. The system may be configured in such a way that, once disabled, the safety line may not be re-enabled until the automation computer 300 and the user interface computer 302 have completed self-tests.

Figure 46 shows a block diagram of the software subsystems of the user interface computer 302 and the automation computer 300. In this example, a “subsystem” is a collection of software, and perhaps hardware, assigned to a specific set of related system functionality. A “process” can be an independent executable that operates in its own virtual address space and passes data to other processes using communication facilities of

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163 interprocess.

This executive subsystem 332 includes the software and scripts used for inventory, verification, startup, and monitoring of the execution of the software that operates on the CPU of the automation computer 300 and the CPU of the user interface computer 302. A client executive process is operated on each of the above CPUs. Each executive process loads and monitors the software on its own processor and monitors the executive on the other processor.

The user interface (Ul) subsystem 334 handles system interactions with the user and the clinic. The Ul 334 subsystem is implemented according to a “model-view controller” design pattern, which separates the display of data (“view”) from the data itself (“model”). In particular, system state and data modification functions (“model”) and cycler control functions (“controller”) are handled by the Ul model and cycler controller 336 on the automation computer 300, while the “view” portion of the subsystem is handled by the Ul 338 screen view on the Ul 302 computer. Data display and export functionality, such as record viewing or remote access, can be handled entirely by the Ul 338 screen view. The Ul 338 screen view monitors and controls additional applications, such as those that provide record viewing and a clinical interface. These applications are switched within a window controlled by the Ul 338 screen view, allowing for seamless control.

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164 You can return to the Ul 338 screen view in the event of an alert, alarm, or error.

The 340 therapy subsystem directs and regulates the timing of dialysis treatment delivery. It may also be responsible for verifying a transcript, calculating the number and duration of therapy cycles based on the prescription, time, and available fluids, monitoring therapy cycles, tracking fluid in supply bags, tracking fluid in the heater bag, tracking the amount of fluid in the patient, tracking the amount of ultrafiltrate removed from the patient, and detecting alert or alarm conditions.

Machine control subsystem 342 controls the machinery used to implement dialysis therapy, orchestrating the high level of pumping and control functionality when required by therapy subsystem 340. In particular, flow control functions can be reviewed by machine control subsystem 342: air compressor control; heater control; fluid supply (pumping) control; and fluid volume measurement. The machine control subsystem 342 also signals and sends sensor readings via the l/O subsystem 344, described below.

The I/O subsystem 344 in the automation computer 300 controls access to the sensors and actuators used to control the therapy. In this implementation, the I/O subsystem 344 is the only application process that manages access to the hardware. Therefore, the I/O subsystem

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165

344 publishes an interface to allow other processes to obtain hardware inputs and set the state of hardware outputs.

The 346 database subsystem, also a 302 user interface computer, stores all data to and retrieves all data from the databases used for internal machine storage, patient, prescription, user input, and treatment history information. This provides a common access point when such information is needed by the system. The interface provided by the 346 database subsystem is used by several processes for their data storage needs. The 346 database subsystem also handles database file maintenance and backups.

The Ul 338 screen view can invoke a therapy record query application to search the therapy history database. Using this application, which can alternatively be implemented as multiple applications, the user can graphically review their treatment history, prescriptions, and/or historical machine status information. The application transmits database queries to the 346 database subsystem. The application can be run while the patient is undergoing dialysis without hindering the safe operation of the machine.

The remote access application, which can be implemented as a single application or multiple applications, provides the functionality to export machine therapy and diagnostic data for analysis and/or

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166 Deployment to remote systems. The therapy record question application can be used to retrieve required information, and the data can be reformatted into a machine-neutral format, such as XML, for transport. The formatted data can be transported externally by a memory storage device, direct network connection, or other external interface. Network connections can be initiated by the APD system, as required by the user.

The 356 service interface can be selected by the user when therapy is not in progress. The 356 service interface may include one or more specialized applications that record test results and optionally generate a test report that can be uploaded, for example, to a diagnostic center. The 38 media player, for example, can play audio and/or video for presentation to a user.

In accordance with an illustrative implementation, the databases described above are implemented using SQLite, a software library that implements a zero-configuration, serverless, self-contained transactional SQL database machine.

The executive subsystem 332 implements two executive modules: the user interface computer (UIC) executive 352 on the user interface computer 302 and the automation computer (AC) executive 354 on the automation computer 300. Each executive is initiated by startup scripts that operate after

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167 The operating system starts up and includes a list of processes that it launches. As the process executives go through their respective process lists, each process image is checked to ensure its integrity in the file system before the process is launched. The administrators monitor each child process to ensure that each one starts as expected and continue monitoring the child processes as they operate, e.g., using Linux parent-child process notifications. When a child process terminates or crashes, the administrator either restarts it (as in the case of the Ul view) or puts the system into failsafe mode to ensure that the machine behaves safely. Executive processes are also responsible for the clean shutdown of the operating system when the machine is turned off.

The executive processes communicate with each other, allowing them to coordinate the start and stop of the various application components. State information is periodically shared between the two executives to support a watchdog function between the processors. Executive subsystem 332 is responsible for enabling or disabling the secure line. Once both the UIC 352 and AC 354 executives have authorized the safe line, the pump, heater, and valves can operate. Before enabling the lines, the executives test each line independently to ensure proper operation. Additionally, each executive monitors the status of the other safe line.

The UIC 352 executive and the AC 354 executive work together to synchronize the time between the user interface computer 352 and the

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168 Automation computer 300. The time base is set using a battery-backed real-time clock in user interface computer 302, which is accessed at startup. User interface computer 302 initializes the CPU of automation computer 300 to the real-time clock. After that, the operating system on each computer maintains its own internal time. Executives work together to ensure adequate maintenance by periodically performing power-on self-tests. An alert can be generated if a discrepancy between the automation computer's timing and the user interface computer's timing exceeds a given threshold.

Figure 47 shows the information flow between various subsystems and processes of the APD system. As described earlier, the Ul 360 model and cycler controller 362 operate on the automation computer. The user interface design separates the screen display, which is controlled by the Ul 338 view, from the screen-to-screen flow, which is controlled by the cycler controller 362, and the display data items, which are controlled by the Ul 360 model. This allows the visual representation of the screen to be changed without affecting the underlying therapy software. All therapy and context values ​​are stored in the Ul 360 model, isolating the Ul 338 view from safety-critical therapy functionality.

The Ul 360 model adds information describing the current state of the system and patient, and maintains information that can be

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169 displayed by the user interface. The III 360 model can update a state that is not currently visible or otherwise discernible to the operator. When the user navigates to the new screen, the III 360 model provides information related to the new screen and its content to the III 338 view. The Ul 360 model exposes an interface that allows Ul 338 or another process to query the current user interface screen and the content to be displayed. The Ul 360 model thus provides a common point from which interfaces such as the remote user interface and online support can obtain the current operating system status.

The Cycler 362 controller manages system state changes based on operator input, time, and therapy layer status. Acceptable changes are reflected in the Ul 360 model. The Cycler 362 controller is implemented as a hierarchical state machine that coordinates therapy layer commands, therapy status, user requests, and time-regulated events, and provides display screen control via Ul 360 model updates. The cycler controller 362 also validates user inputs. If the user inputs are allowed, new values ​​related to the user inputs are reflected back to the Ul 338 view using the Ul 360 model. The therapy process 368 acts as a server for the cycler controller 362. Therapy commands from the cycler controller 360 are received by the therapy process 368.

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170

The Ul 338 view, which operates on the Ul 302 computer, controls the user interface display and responds to user input from the touch screen. The Ul 368 view maintains local screen state tracking but does not maintain machine state information. Machine state and displayed data values, unless they are in the process of being changed by the user, are derived from the Ul 360 model. If the Ul 338 view terminates and is restarted, it displays the base screen for the current state with current data. The Ul 338 view determines which screen class will be displayed from the Ul 360 model, leaving the actual screen presentation to the Ul view. All critical user interface security aspects are handled by the Ul 360 model and the 362 cycler controller.

The Ul 338 view can load and run other 364 applications on the user interface 302 computer. These applications can perform non-therapy controller tasks. Illustrative applications include the record viewer, the service interface, and remote access applications. The Ul 338 view places these applications within a window controlled by the Ul view, allowing the Ul view to display status, error, and alert screens as appropriate. Certain applications can be operated during active therapy. For example, the record viewer can operate during active therapy, while the service interface and the remote access application generally do not. When an application subserver in view of Ul 338 is operating and attention

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171 If the user's intervention is required by ongoing therapy, the Ul 338 view can suspend the application and regain control of the screen and input functions. The suspended application can be resumed or aborted by the Ul 338 view.

Figure 48 illustrates the operation of the therapy subsystem 340 described in conjunction with Figure 46. The therapy subsystem 340 is functionally divided into three processes: therapy control; therapy calculation; and solution management. This allows for functional decomposition, ease of testing, and ease of updating.

The therapy control module 370 uses the services of the therapy calculation module 372, solution handling module 374, and machine control subsystem 342 (Figure 46) to accomplish its tasks. The responsibilities of the 370 therapy control module include tracking fluid volume in the heater bag, tracking fluid volume in the patient, tracking patient drained and ultrafiltrated volumes, tracking and recording cycle volumes, tracking and recording therapy volumes, arranging the execution of dialysis therapy (drain-fill-residence), and controlling therapy preparation operations. The 370 therapy control module performs each phase of therapy as directed by the 370 therapy calculation module.

The 370 therapy calculation module tracks and recalculates the drain-fill-residence cycles that comprise a peritoneal dialysis therapy. Using the patient's prescription, the calculation module

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172 Therapy 372 calculates the number of cycles, residence time, and the amount of solution required (the total therapy volume). As therapy proceeds, a subset of these values ​​is recalculated, applying the current elapsed time. The Therapy 372 calculation module tracks the therapy sequence, passing therapy phases and parameters to the Therapy 370 control module when required.

The solution handling module 374 maps the placement of solution supply bags, tracks the volume in each supply bag, commands the mixing of solutions based on recipes in the solution database, commands the transfer of the required volume of mixed or unmixed solution into the heater bag, and tracks the volume of available mixed solutions using the solution recipe and available bag volume.

Figure 49 shows a sequence diagram illustrating illustrative interactions of the therapy module processes described above during the initial filling and dialyzing portions of therapy. During the illustrative initial filling process 376, the therapy control module 370 looks up the solution ID and volume for the first filling from the therapy calculation module 372. The solution ID is passed to solution handling module 374 with a request to fill the heater bag with solution, in preparation for priming the patient line and the first patient fill. Solution handling module 374 passes the request to machine control subsystem 342 to begin pumping the solution.

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173 solution to the heater bag.

During the illustrative dialysis process 378, the therapy control module 370 executes a cycle (initial drain, fill, refill, and drain) at a time, sequencing these cycles under the control of the therapy calculation module 372. During therapy, the therapy calculation module 372 is updated with the actual cycle time, so it can recalculate the remainder of the therapy if necessary.

In this example, the therapy calculation module 372 specifies the phase as “initial drainage,” and the therapy control module makes the request to the machine control subsystem 342. The next phase specified by the therapy calculation module 372 is “filling.” The instruction is sent to the machine control subsystem 342. The therapy calculation module 372 is required again by the therapy control module 370, which requires that the fluid be refilled into the heater bag during the "residence" phase. The solution handling module 374 is required by the therapy control module 370 to refill the heater bag with fluid when required by the machine control subsystem 342. The processing continues with the therapy control module 370, which requires the therapy calculation module 372 to proceed to the next phase. This is repeated until there are no more phases, and the therapy is complete.

Alert/alarm functions

Conditions or events in the APD system may

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174 To trigger alerts and/or alarms that are logged, displayed to a user, or both. These alerts and alarms are a user interface construct residing in the user interface subsystem and can be triggered by conditions occurring anywhere in the system. These conditions can be grouped into three categories: (1) system error conditions, (2) therapy conditions, and (3) system operating conditions.

“System error conditions” refers to errors detected in the software, memory, or other aspects of the APD system processors. These errors compromise the reliability of the system and may be considered “unrecoverable.” System error conditions cause an alarm to be displayed or otherwise made known to the user. The alarm may also be logged. Since system integrity cannot be guaranteed in the event of a system failure condition, the system may enter a fail-safe mode in which the safety line described here is disabled.

Each subsystem described in connection with Figure 46 is responsible for detecting its own system errors. System errors between subsystems are monitored by the user interface computer executive 352 and the automation computer executive 354. When a system error originates from a process running on the user interface computer 302, the process reporting the system error terminates. If the Ul 338 screen view subsystem is terminated,

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175 The UI 352 computer executive attempts to restore it, e.g., up to a maximum of three times. If it fails to restore the Ul 338 screen view and therapy is in progress, the UI 352 computer executive transitions the machine to a fail-safe mode.

When a system error originates from a process running on automation computer 300, the process terminates. Automation computer 354 detects that the process has terminated and transitions to a safe state if therapy is in progress.

When a system error is reported, an attempt is made to inform the user, e.g., with visual and/or audio feedback, as well as to log the error to a database. System error handling is encapsulated in the 332 executive subsystem to ensure consistent handling of unrecoverable events. The executive process of the UIC 352 executive and the AC 354 executive monitor each other in such a way that if one executive process fails during therapy, the other executive performs machine transitions to a safe state.

“Therapy conditions” are caused by a state or variable associated with therapy that is outside of permissible limits. For example, a therapy condition may be caused by an out-of-limit sensor reading. These conditions may be associated with an alert or alarm and subsequently logged. Alarms are critical events that

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176 They generally require immediate action. Alarms can be prioritized, for example, as low, medium, or high, based on the severity of the condition. Alerts are less critical than alarms and generally have no associated risk other than missed therapy or discomfort. Alerts can fall into one of three categories: message alerts, escalation alerts, and user alerts.

The responsibility for detecting therapy conditions that may cause an alarm or alert is shared between the Ul model and the therapy subsystems. The Ul 360 model subsystem (Figure 47) is responsible for detecting alarm and alert conditions before and after therapy. The 340 therapy subsystem (Figure 46) is responsible for detecting alarm and alert conditions during therapy.

Responsibility for handling alerts or alarms associated with therapy conditions is also shared between the Ul model and therapy subsystems. Before and after therapy, the Ul 360 model subsystem is responsible for managing alarm or alert conditions. During a therapy session, the 340 therapy subsystem is responsible for handling alarm or alert conditions and notifying the Ul model subsystem that an alarm or alert condition exists. The 360 ​​Ul model subsystem is responsible for escalation alerts and for coordinating with the 338 view subsystem to provide the user with visual and/or audio feedback when necessary.

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177 an alarm or alert condition has been detected.

“System operating condition” does not have an associated alert or alarm. These conditions are simply recorded to provide a record of system operations. No auditory or visual feedback is required.

The actions that can be taken in response to the system error conditions, therapy conditions, or system operating conditions described above are implemented by the subsystem (or layer) that detected the condition, which then transmits the status to higher-level subsystems. The subsystem that detected the condition may log the condition and address any safety considerations associated with it. These safety conditions may include any or a combination of the following: pausing therapy and engaging the occluder; clearing statuses and time regulators as needed; disabling the heater; terminating therapy completely; deactivating the safety line to close the occluder, shut off the heater, and remove power from the valves; and prevent the cycler from performing therapies even after a power cycle, thus requiring the system to be sent back into service. The Ul 334 subsystem may be responsible for conditions that can be automatically cleared (i.e., unlocked conditions) and for user-recoverable conditions that are locked and can only be cleared by user interaction.

Each condition can be defined in such a way that it contains

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178 certain information to allow the software to act in accordance with the severity of the condition. This information may include a numeric identifier, which can be used in combination with a lookup table to define priority; a descriptive name for the error (i.e., a condition name); the subsystem that detected the condition; a description of what state or error triggers the condition; and flags for whether the condition implements one or more previously defined actions.

Conditions can be prioritized so that when multiple conditions occur, the highest priority condition is addressed first. This priority ranking can be based on whether the condition halts therapy delivery. When a condition occurs that stops therapy, it takes precedence when transmitting the status to the next higher subsystem. As described earlier, the subsystem that detects a condition handles the condition and sends status information to the preceding subsystem. Based on the received status information, the upstream subsystem can trigger a different condition, which may have different actions and a different alert/alarm associated with it. Each subsystem implements any additional actions associated with the new action and passes the status information back to the preceding subsystem. According to an illustrative implementation, the Ul subsystem only displays one alert/alarm at a given time. In this case, the Ul model classifies all active events by priority and displays the alert/alarm that is

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179 associated with the highest priority event.

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An alarm can be assigned a priority based on the severity of the potential damage and the onset of that damage. Table 1 below shows an example of how priorities can be assigned in this way.

TABLE 1

POTENTIAL RESULT OF FAILURE TO RESPOND TO THE CAUSE OF ALARM CONDITION

Death or irreversible injury. Reversible injury.

Minor discomfort or injury

ONSET OF POTENTIAL DAMAGE

IMMEDIATE QUICKLY RECHARGED

High priority High priority

High priority High priority

Medium priority Low priority

Medium priority Low priority Low priority or no alarm signal

In the context of Table 1, the onset of potential harm refers to when an injury occurs, not when it becomes apparent. Potential harm with an onset designated as “immediate” denotes harm that has the potential to develop within a period not usually sufficient for manual corrective action. A potential hazard with a designated start date of "soon" denotes a hazard that has the potential to develop within a period usually sufficient for manual corrective action. A potential hazard with a designated start date of "delayed" denotes a hazard that has the potential to develop over an unspecified time longer than that given under "soon."

Figures 50-55 show illustrative screen views

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180 related to alarm alerts that can be delayed on a touchscreen user interface. Figure 50 shows the first screen of an alarm, which includes a diagram 380 and text 382 instructing a user to shut down their transfer equipment. The screen includes a visual warning 384 and is also associated with an audio warning. The audio warning can be turned off by selecting the “audio off” option 386 on the touchscreen. When the user has closed the transfer unit, the user selects the “confirm” option 388 on the touch screen. Figure 51 shows a similar alarm screen that instructs a user to close their transfer unit. In this case, an indication that drainage is paused 390 and an instruction to select “end of treatment” are provided in 392.

As described above, alerts generally have no associated risks other than missed therapy or discomfort. Therefore, an alert can either trigger or cause therapy to be paused. Alerts can be either "self-recovering," so that if the event clarifies the alert, it is automatically cleared, or "user-recoverable," so that user interaction with the user interface is required to clear the alert. An audible alert message, with adjustable volume within certain limits, can be used to draw a user's attention. Additionally, information or instructions can be displayed to the user. This information or instruction can then be viewed by the user, a feature of the auto-dimming function.

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181 The user interface can be disabled during alerts.

To minimize user disruption, alerts can be categorized based on their importance and the urgency of the user response. Three illustrative alert types are message alerts, escalation alerts, and user alerts. These alerts differ in how the information is visually presented to the user and how the audible message is used.

A “message alert” can appear at the top of the status screen and is used for informational purposes when no user interaction is required. Because no action is needed to clear the alert, an audible message is generally not used to avoid disturbance and potentially waking the patient. However, an audible alert can be optionally presented. Figure 52 shows an illustrative message alert. In particular, Figure 52 shows a low temperature message alert 394 that can be used to inform a user when the dialysate is below a desired temperature or within a desired range. In this case, the user does not need to take any action, but is informed that therapy will be delayed while the dialysate is warmed. If the patient desires more information, the “view” option 396 can be selected on the touch screen. This causes additional information 398 related to the alert to appear on the screen, as shown in Figure 53. A message alert can also be used when there is a

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182 A low-flow event that the user is trying to correct. In this case, a message alert can be displayed until the low-flow event is cleared to provide feedback to the user on whether the problem was fixed.

An “escalation alert” is designed to prompt the user to take action in a non-intrusive manner. During an escalation alert, a visual message may be displayed on the touchscreen, and an audible message may be presented (e.g., once). After a specified period, if the event that triggered the alert remains unresolved, a more emphatic audible message may be presented. If the event causing the alert is not resolved after a certain period, the alert is escalated to a "user alert." According to an illustrative implementation of a user alert, a virtual message is displayed until the alert is resolved, and then an audible message, which can be muted, is presented. The Ul subsystem does not handle the transition from an escalated alert to a user alert. Rather, the subsystem that triggered the original event will trigger a new event associated with the user alert. Figure 54 shows a screen list displaying information regarding an escalation alert. This illustrative alert includes an on-screen alert message 400 and a message 402 instructing the user to check the drain line for faults and closed clamps, as well as an audible message. The audible message can continue until muted by the user. Figure 55 shows a screen view that includes a “mute audio” option.

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183 which can be selected to mute the audio message. This alert can be used directly or as part of the escalation alert scheme.

Each alert/alarm is specified by an alert/alarm code, which is a unique identifier for the alert/alarm; an alert/alarm name, which is a descriptive name for the alert/alarm; an alert/alarm type, which comprises the type of alert or alarm level; an indication of whether an audible message is associated with the alert/alarm; an indication of whether the alert and associated event can be dismissed (or ignored) by the user; and an event code for the event or events that trigger the alert/alarm.

During alarms, escalation alerts, and user alerts, the event code (which may be different from the alert or alarm code, as described above) may be displayed on the screen so that the user can read the code to service personnel if necessary. Alternatively or additionally, a voice guidance system can be used so that, once connected to a remote call center, the system can locate relevant information about the system's configuration, status, and error codes. The system can be connected to the remote call center via a network, telephone line, or other means.

An example of a condition detected by the therapy subsystem will be described later in connection with Figure 56. The resulting condition occurs when the APD system is not located on a level surface, which is important for air handling. Most notably, the

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184 This condition occurs when a tilt detector senses that the APD system is tilted beyond a predetermined threshold, such as 35°, relative to a horizontal plane. As described later, a recallable user alert can be generated by the therapy subsystem if the tilt sensor detects an angle with an absolute value greater than the predetermined threshold. To avoid troublesome alarms, the user can be instructed to level the APD system before therapy begins. The tilt threshold can be lower during this pre-therapy period (e.g., 35°). The user can also receive feedback regarding whether the problem is corrected.

When the tilt sensor detects a tilt angle exceeding a threshold during therapy, machine subsystem 342 responds by stopping the pump, similar to how it would if it detected air in the pump chamber. Therapy subsystem 340 queries the status and determines that machine layer 342 has paused pumping due to tilt. It also receives status information regarding the machine angle. At this point, the therapy subsystem 340 generates a tilt condition, pauses therapy, and sends a command to the machine subsystem 342 to pause pumping. This command triggers cleaning, such as taking fluid metering system (FMS) measurements and closing the patient valve. The therapy subsystem 340 also initiates a timer and sends a self-recovering tilt condition to the Ul model 360, which then displays the condition in the Ul view.

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185

338. The Ul 338 view maps the condition to an escalation alert. The therapy subsystem 340 continues to monitor the tilt sensor reading and, if it falls below the threshold, clears the condition and restarts therapy. If the condition is not cleared before the timer expires, the therapy subsystem 340 triggers a recoverable “tilt timeout” condition that overrides the self-recovering tilt condition. This condition is sent to the Ul 360 model, which then sends it to the Ul 368 view. The Ul 338 view maps this condition to a user alert. This condition cannot be cleared until a restart therapy command is received from the Ul subsystem (e.g., the user presses the resume button). If the tilt sensor reading is below the threshold, therapy resumes. If it is not below the threshold, the therapy layer triggers a new recoverable tilt condition and starts the time controller.

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Screen display

As described earlier, the Ul 338 view subsystem (Figure 47) is responsible for presenting the interface to the user. The Ul view subsystem is a client of and interfaces with the Ul 360 model subsystem (Figure 47) that operates on the automation computer. For example, the Ul view subsystem communicates with the Ul model subsystem to determine which screen should be displayed to the user at a given time. The Ul view may include

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186 templates for screen views and can handle location-specific preparations such as language, skin, audio language and culturally sensitive on-screen animations.

There are three basic types of events that occur in the Ul view subsystem. These are local screen events, which are handled by individual screens; model events, in which a screen event must propagate to the Ul model subsystem; and scrutiny events, which occur at a time controller and query the Ul model subsystem for its state. A local screen event only affects the Ul view level. These events can be local screen transitions (e.g., in the case of multiple screens for a single model state), updates to view values ​​(e.g., locale and language options), and require playing media videos from a given screen (e.g., instruction animations or voice prompts). Model events occur when the Ul view subsystem must consult with the Ul model subsystem to determine how to handle the event. Examples that fall into this category include confirming therapy parameters by pressing the "start therapy" button. These events are initiated by Ul's view subsystem but handled by Ul's model subsystem. Ul's model subsystem processes the event and returns a result to Ul's view subsystem. This result then drives the internal state of Ul's view subsystem. Scrutiny events occur when a timing regulator generates a timing signal and the model subsystem

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187 Ul is scrutinized. In the event of a scrutiny, the current state of Ul's view subsystem is sent to Ul's model subsystem for evaluation. Ul's model subsystem evaluates the state information and responds with the desired state of Ul's view subsystem. This may constitute: (1) a change of state, e.g., if the major states of the Ul model subsystem and the Ul view subsystem are different, (2) a screen update, e.g., if the values ​​of the Ul model subsystem change values ​​displayed on the screen, or (3) no change in state, e.g., if the state of the Ul model subsystem and the Ul view subsystem are identical. Figure 57 shows the illustrative modules of the Ul 338 view subsystem that perform the functions described above.

As shown in Figure 57, the Ul Model 406 client module is used to communicate events to Ul Model. This Model 406 is also used to query Ul Model for its current state. Within a status response message, the Ul Model subsystem can include a time slot to synchronize the clocks of the automation computer and the user interface computer.

The global slot module 408 provides a mechanism by which multiple callback routines (slots) can subscribe to be notified when given events (signals) occur. This is a many-to-many relationship, since one slot can be bound to many signals, and a signal can also be bound to many slots that are required for its activation. The global slot module 408 handles

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188 non-screen-specific slots, such as application-level time regulators for Ul model scanning or pressing a button that occurs off-screen (e.g., the voice message button).

The screen list class 410 contains a list of all screens in the form of templates and data tables. A screen consists of a template and an associated data table used to populate that screen. The template is a window with artifacts placed on it in a generic way and without any content assigned to the artifacts. The data table includes records that describe the content used to populate the artifacts and the state of the artifacts. An artifact's state can be checked or unchecked (in the case of a register-style artifact), visible or hidden, or enabled or disabled. The data table can also describe the action that occurs as a result of pressing a button. For example, a button in window 'A' derived from template T could send an event to the Ul model, while the same button in window 'B', also derived from template '1', might simply cause a local screen transition without propagating the event to the Ul model. Data tables can also contain an index in the context-sensitive help system.

The 410 screen list class sends data from the Ul model to the intended screen, selects the passed data to the appropriate screen in the Ul model, and displays the screen. The 410 screen list class selects which screen to display based on two factors: the

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189 The state reported by the Ul model and the internal state of the Ul view are interconnected. In some cases, the Ul model can only form the Ul view that is allowed to display any screen within a category. For example, the model might report that the machine is unloaded (e.g., therapy has not started or the startup phase has not yet occurred). In this case, it is not necessary to consult the Ul model when the user navigates from the menu to its submenu. To track changes, the Ul view stores the current screen locally. This local sequencing of screens is handled by the table entries described above. The table entry lists the actions that the respective buttons will initiate when pressed.

The language manager class 412 is responsible for inventorying and handling translations. A checksum can be performed on the list of installed languages ​​to alert the Ul view if any translations are corrupted or missing. Any class that needs a translated string requests the language manager class 412 to perform the translation. Translations can be handled by a library (e.g., Qt®). Ideally, translations should be required as close as possible to the time of execution. To this end, most methods for accessing screen template members require translation immediately before routing the artifact for implementation.

A skin comprises a style sheet and images that determine the "look and feel" of the user interface. The style sheet controls things such as fonts, colors, and which images a user interface will use.

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190 An artifact is used to display its various states (normal, pressed, disabled, etc.). Any displayed artifact can have its appearance altered by a skin change. The Skin Manager module 414 is responsible for reporting the list of screens and, by extension, the screen artifacts, specifying which stylesheet and skin graphics should be displayed. The Skin Manager 414 modulator also includes any animated files that the application might wish to display. On a skin change event, the Skin Manager will update the images and stylesheet in the working set directory with the appropriate set, which is retrieved from the archive.

The video manager module 416 is responsible for playing the appropriate video from a given location upon request to display a particular video. In a location change event, the video manager will update the videos and animations in the working set directory with the appropriate set from a file. The video manager will also play videos that have attached audio, as handled by the audio manager module 418. When playing these videos, the video management module 416 will make the appropriate request to the audio management module 418 to play the recording that belongs to the originally requested video.

Similarly, the audio manager module 418 is responsible for playing the appropriate audio to the location given a request to play a particular audio file. In a location change event, the audio manager will update the audio files in the set directory.

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191 I work with the appropriate set of files. The Audio Manager module 418 handles audio initiated by the Ul view. This includes mixes for animations and sounds for voice messages.

The database client module 420 is used to communicate with the database manager process, which handles the interface between the Ul view subsystem and the 366 database server (Figure 47). The Ul view uses this interface to store and retrieve tasks and to supplement therapy records with user-provided responses to questions about variables (e.g., weight and blood pressure).

The Help Manager module 422 is used to manage the context-sensitive help system. Each page in a screen list that displays a help button can include an index in the context-sensitive help system. This index allows the help manager to display the help screen associated with a page. The help screen can include text, images, audio, and video.

The ID 424 auto-administrator is required during pre-therapy preparation. This module is responsible for capturing an image (e.g., a photograph) of a solution bag code (e.g., a data matrix code). The data extracted from the image is then sent to the machine's control subsystem to be used by the therapy subsystem to identify the contents of a solution bag, along with any other information (e.g., origin, included in the code).

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192

Using the modules described above, the Ul 338 view subsystem generates the screen views that are displayed to the user through the user interface (e.g., screen 324 in Figure 45). Figures 58–64 show illustrative screen views that can be generated by the UL view subsystem. These screen views illustrate, for example, input mechanisms, display formats, screen transitions, icons, and strokes. Although the screens shown are generally displayed during or before therapy, aspects of the screen views can be used for different input and output functions than those shown.

The screen shown in Figure 58 is an initial view that provides the user with the option to select either “start therapy” 426 to begin the specified therapy 428 or “values” 430 to change values. Icons 432 and 434 are provided respectively for adjusting brightness and audio levels, and an information icon 436 is provided to allow the user to request more information. These icons may appear on other screens in a similar manner.

Figure 59 shows the status screen that provides information on the therapy status. In particular, the screen indicates the type of therapy being performed 438, the estimated completion time 440, and the current fill cycle number and total number of fill cycles 442. The percentage completion of the current fill cycle 444 and the percentage completion of the total therapy 446 are displayed both numerically and graphically.

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193 deployed. The user can select a “pause” option 448 to pause therapy.

Figure 60 shows a menu screen with various comfort settings. The menu includes brightness arrows 450, volume arrows 452, and temperature arrows 454. By selecting the up or down arrow for each respective pair, a user can increase or decrease the screen brightness, audio volume, and fluid temperature. The current brightness percentage, volume percentage, and temperature are also displayed; when the values ​​are as desired, a user can select the “accept” button 456.

Figure 61 shows a help menu, which can be accessed, for example, by pressing a help or information button on a previous screen. The help menu may include text 458 and/or an illustration 460 to assist the user. The text and/or illustration may be context-sensitive or based on the context of the previous screen. If the information provided to the user cannot be conveniently displayed on one screen, for example, in the case of a multi-step process, arrows 462 can be provided to allow the user to navigate back and forth between a series of screens. When the user has obtained the desired information, they can preselect the “back” button 464. If additional help is required, a user can select the “call service center” option 466 to have the system contact the call service center.

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194

Figure 62 illustrates a screen that allows a user to set a set of parameters. For example, the screen displays the current therapy mode 468 and minimizes the drainage volume 470, and allows a user to select these parameters to be changed. The parameters can be changed in a number of ways, such as by selecting a desired option from an authorized one-way menu. Alternatively, when the user selects a parameter to be changed, a new screen appears, such as the one shown in Figure 63. The screen in Figure 63 shows a user adjusting the minimum drain volume by entering a numeric value 472 using key 474. Once entered, the user can confirm or cancel the value using buttons 476 and 478. Referring again to Figure 62, a user can then use the “back” and “next” arrows 480, 482 to navigate through a series of parameter screens, each including a different set of parameters.

Once all the desired parameters have been set or changed (e.g., when the user has navigated through the series of parameter screens), a screen such as the one shown in Figure 64 can be displayed to allow the user to review and confirm the values. The parameters that have changed can optionally be highlighted to draw the user's attention. When the values ​​are as desired, the user can select the button.

MX/a/2021/007240 confirm” 486.

<img file="MX428429B_D0006.tif" />

IMPIs

MEXICAN INSTITUTE OF PROPERTY IO

INDUSTRIAL &lt;o

195

Although aspects of the invention have been described along with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, the embodiments of the invention as set forth herein are intended to be illustrative and not limiting. Various changes may be made without departing from the spirit and scope of the invention.