Abstract: An automated peritoneal dialysis system provides various features including prescription-driven dialysis fluid preparation, an integrated disposable fluid circuit, and sensor capabilities that allow accurate filing and draining control with high safety margins. Features include a peritoneal fluid circuit with a pressure sensor at either end and methods and devices for using the pressure signals. Other features and embodiments are disclosed.

Abstract: The disclosed subject matter includes embodiments of fluid couplings that prevent or discourage misconnection of fluid lines. A coupling device includes multiple male and female connectors that are joined to a common line. The coupling device is mated to a matching coupling device only when all the multiple male and female connectors are property joined. If any of the connectors is not property mated to a corresponding one, the coupling will leak. The coupling devices are made unique by providing an arrangement the connectors, number of connectors, shape of connectors or arrangement of interfering connector parts that ensure that any attempt to improperly couple two fluid lines will result in the incomplete mating of one or more of the connectors and thereby cause leakage of the fluid, failure of the coupling to engage, or otherwise cause the attempt to connect to fail.

Abstract: An automated peritoneal dialysis system provides various features including prescription-driven dialysis fluid preparation, an integrated disposable fluid circuit, and sensor capabilities that allow accurate filing and draining control with high safety margins. Features include a peritoneal fluid circuit with a pressure sensor at either end and methods and devices for using the pressure signals. Other features and embodiments are disclosed.

Abstract: A pressure measurement system for use in blood circuits comprised of a pressure sensing pod and a force measurement device. The pressure sensing pod can include a flexible, moveable, fluid-impermeable diaphragm and can be formed via either a one-shot or a two-shot molding process. A mechanical engagement member of the force measurement device engages with a mechanical engagement feature of the diaphragm, and the engagement member is operative to move in concert with movement of the engagement feature of the diaphragm based on pressure variations with the pressure sensing pod. The force measurement device generates and outputs to a processor a signal based on detected force associated with movement of the engagement member.

Abstract: Releasable tubing pinch clamps of a generally U-shaped configuration are described. The embodiments include ones that prevent cross-clamping of the tube by various interlocking features on riser portions of the clamp. Methods and molds for making the pinch clamps are also described. The pinch clamp consists generally of a strip that curves so that its ends can be brought together by manually squeezing the strip at its ends which oppose each other as a result of the strip curve. The strip ends contain locking edges or surfaces that cause the strip ends to interferingly engage with each other and lock together. The strip also contains opposing pinching projections that pinch a tube.

Abstract: Releasable tubing pinch clamps of a generally U-shaped configuration are described. The embodiments include ones that prevent cross-clamping of the tube by various interlocking features on riser portions of the clamp. Methods and molds for making the pinch clamps are also described. For example, a pinch clamp can have a strip that curves so that its ends can be brought together by manually squeezing the strip at its end, which oppose each other as a result of the strip curve. The strip ends have locking edges or surfaces that cause the strip ends to interferingly engage with each other and lock together. The strip also has opposing pinch projections that can pinch a tube.

Abstract: Features for protecting against leaks in a fluid circuit are disclosed. In an embodiment, a first indicator of a leak is used to trigger confirmation by blood flow reversal and air detection in the blood circuit. A method for performing a blood treatment includes, at blood treatment machine, pumping blood to a patient through a first blood line. Further, at a controller of the blood treatment machine, a first signal is received, indicating a probability of a leak in the first blood line. Responsively to the first signal, the controller commands a leak verification operation and receives a second signal indicating whether a leak in the first blood line is verified. Further, a leak indicating signal is generated if the second signal indicates a leak is verified.

Abstract: A system associated with a medical treatment device for detecting a condition of a patient includes an input device including at least a camera or a microphone. The system also includes a medical treatment device with a controller/classifier and at least one of flow controller, a pump, and/or an alarm output. The controller/classifier has at least a video-image processor or an audio processor configured to recognize a face and a body or to recognize changes in skin color, facial expression, or body position. The controller/classifier may also recognize speech and classify predefined normal and irregular sound patterns, and output state data corresponding thereto. The controller/classifier is connected to apply the state data to the at least one flow controller, pump, and/or alarm output. The controller/classifier is further adapted to control the at least one flow controller, pump, and/or alarm output responsively to the state data.

Abstract: The disclosed subject matter relates to extracorporeal blood processing or other processing of fluids. Volumetric fluid balance, a required element of many such processes, may be achieved with multiple pumps or other proportioning or balancing devices which are to some extent independent of each other. This need may arise in treatments that involve multiple fluids. Safe and secure mechanisms to ensure fluid balance in such systems are described.

Abstract: Embodiments include a consumable medical device comprises a rigid cartridge to which a film is adhered to form a fluid channel and a damper chamber. A portion of the film forming the damper chamber has a wave-like shape adapted to roll onto a tip of a damper. The damper has a plunger to minimize peristaltic pressure in the channel The cartridge may include conductivity measurement channels. Crosstalk may be minimized by using different frequencies or time division for reading the channels. A stable dialysate concentrate containing sodium lactate may be used or generated with the system.

Abstract: A medicament preparation system, according to an embodiment, includes a water purification module and a medicament proportioning module. The system is configured to allow convenient and safe use in a home environment or a critical care environment as well as others affording safety, reliability, and a compact form factor.

Abstract: A fluid preparation system has a sealed sterilized fluid circuit with a sealed sterilized container with a conductivity sensor in communication with an interior of said container. Further, at least one sealed connector is adapted for adding fluid to said container, and at least one sealed connector is adapted for removing fluid from said container. The conductivity sensor is contained in a test line in communication with said interior and is adapted to be connected to a source of suction thereby to draw a sample of contents of said container. Furthermore, the test line may have a check valve to prevent ingress of contaminants into said container, and the sealed connector is adapted for adding fluid to said container and may have an inline sterile filter. Furthermore, the system may have a controller that controls pumping actuators.

Abstract: A peritoneal dialysis device includes a disposable tubing set that includes a fill line with a patient access connector at one end and a dialysis fluid receiving end opposite the patient access connector end. The device also includes a fill-side pressure measuring sensor attached at the fill end and forming a disposable component of the tubing set and a patient-side pressure measuring sensor located at the fluid receiving end. The patient-side and fill-side pressure measuring sensors are adapted for measuring pressure in the fill line at the respective ends thereof. The device also includes a controller configured to regulate a rate of flow in the fill line responsively to a signal from the at least the patient-side pressure measuring sensor.

Abstract: Features for protecting against leaks in a fluid circuit are disclosed. In a first embodiment, a fluid circuit is housed by another fluid circuit that is configured to capture and convey leaks to leak detector. In a second embodiment, a first indicator of a leak is used to trigger confirmation by blood flow reversal and air detection in the blood circuit.

Abstract: One of the most significant safety concerns in the automation of extracorporeal blood treatments such as dialysis is the risk of blood leakage. Extracorporeal blood treatment systems draw blood at such a high rate that a loss of integrity in the blood circuit can be serious. There are a number of mechanisms for detecting and preventing leaks, but none is perfect. This tends to limit the use of such equipment in unsupervised settings, such as the home will be limited. Some leak detection schemes can be made sensitive enough to detect the barest of leaks, but when this is done, they result in too many false positives. The invention combines information from multiple inputs to enhance sensitivity in leak detection and reduce the problem of false positives.

Abstract: A system that fills multiple containers includes a filter with an inlet port and multiple outlet ports. The outlet ports are pre-attached to containers by respective filling lines of each container. Each container has an interior and each of the respective filling lines is connected to a respective container interior. All of the respective filling lines are sealed to the outlet ports and the containers such that the container interiors are isolated from an external environment except the inlet port, via the filter, forming a combined interior volume which is sterile. The system can produce batches of multiple sterile containers with sterile medicament in the containers.

Abstract: A method of performing a dialysis treatment includes using a pump and a dialysate supply line to transport peritoneal dialysis fluid, the supply line having a proximal end into which peritoneal dialysis fluid is supplied and from which spend dialysate is withdrawn, and a distal end which is connected to a patient's peritoneal access. The method further includes generating proximal and distal pressure signals using pressure detectors located at both the proximal and distal ends, respectively, of said supply line. During a drain cycle in which spent dialysate is pumped from the patient, the method includes, responsively to the proximal and distal pressure signals, detecting a characteristic of a pressure difference between the distal and proximal ends whose magnitude is determined by a predicted change in dialysate properties, and responsively to the characteristic, generating a signal indicating the change in dialysate properties.

Abstract: A method of performing a peritoneal dialysis treatment includes connecting a disposable unit to a source of water. The disposable unit includes at least a first container holding a sterile concentrate containing an osmotic agent, a second container holding a sterile concentrate containing electrolytes, an empty sterile mixing container, and a tubing set with a pre-attached peritoneal fill/drain line. The method also includes receiving a prescription command by a controller, indicating at least the fill volume and desired final concentration of the osmotic agent to be used for a current fill cycle under said treatment, and pumping a quantity of the concentrated osmotic agent that is at least sufficient to achieve the desired final concentration into the mixing container. The contest of the mixing container are mixed, further diluted or concentrated, and then flowed to a patient.

Abstract: A disposable fluid circuit used in a medical device that performs peritoneal dialysis includes a peritoneal dialysis tubing set that has a connection tube with a connector for a peritoneal catheter at a distal end and a connector configured to connect to a peritoneal cycler at a proximal end. The circuit also includes a pressure pod at the distal end, the pressure pod being of the type that has a flow chamber for carrying a liquid and an air chamber separated from the flow chamber by a diaphragm and an air port in fluid communication with the air chamber. The flow chamber is connected in-line with a lumen of the connection tube and a length of tubing runs from the air-port along the length of the connection tube with a connector at the proximal end configured to connect to a pressure transducer.