Abstract: A method of performing a peritoneal dialysis treatment includes connecting a disposable unit to a source of water, the disposable unit including 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 further 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 using the controller, pumping a quantity of the concentrated osmotic agent that is at least sufficient to achieve the desired final concentration into the mixing container. The contents of the mixing container are mixed, further diluted or concentrated, and then flowed to a patient.

Abstract: Systems, methods, and devices for preparation of water for various uses including blood treatment are described. In embodiments, fluid is passed either by pump or passively by gravity feed, through various filtration elements from a fluid source to a treatment fluid container. The latter forms a batch that may be used during treatment. Methods and systems for creating multiple-treatment batches are described. Advantages of creating a multitreatment batch include the fact that the burden of treatment preparation can be reduced and the timing of the preparation of the batch can be independent of the treatment time. As described, there are various trade-offs and concerns with this approach which are addressed by the inventive embodiments.

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: Systems, methods, and devices for preparation of purified water and medicaments for various uses including blood treatment are described. Methods, devices, and systems for creating multiple-treatment batches are described. For example, a medicament fluid circuit can include a container with an interior chamber. The container can have a fluid filling port and a fluid extraction port. Both ports can be connected to the interior chamber. The filling port can have two sterilizing filters, each of which has a membrane. The sterilizing filters can be connected in series the membranes are separated by a distance of at least 0.5 cm. A first of the sterilizing filters can have a sealed inlet. The fluid extraction port can be sealed.

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: 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: A flow reversing device for performing blood treatment can include a flow reversing actuator. The flow reversing actuator can receive and engage a disposable tubing set with multiple branches that form forward and reverse blood flow paths respectively when blood the flow reversing actuator is selectively changed between forward and reverse configurations. The shape of the tubing can be such that during forward operation, dead regions of non-flowing blood are defined. The flow reversing actuator can have a controller configured to operate generally in forward mode. At first times, the controller can cause the flow reversing actuator to clear the dead regions. At second times, the controller can cause the flow reversing actuator to test for leaks by reversing the flow of blood for a period of time sufficient to cause air to be drawn into the tubing set and conveyed to an air sensor.

Abstract: An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

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: An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

Abstract: The disclosed subject matter includes a structure and method for making a dual-lumen needle from single lumen needles to take advantage of the much higher economies of scale. Variations include two needles joined by a flow junction and one needle and a single cannula joined by a flow junction. In addition disclosed are methods of using a dual-lumen needle in a two needle access for blood treatment is disclosed in which at least venous flow is provided through a dual-lumen needle with arterial flow just sufficient to provide air infiltration detection in the event of withdrawal of the dual-lumen needle.

Abstract: The disclosed subject matter includes a structure and method for making a dual-lumen needle from single lumen needles to take advantage of the much higher economies of scale. Variations include two needles joined by a flow junction and one needle and a single cannula joined by a flow junction. In addition disclosed are methods of using a dual-lumen needle in a two needle access for blood treatment is disclosed in which at least venous flow is provided through a dual-lumen needle with arterial flow just sufficient to provide air infiltration detection in the event of withdrawal of the dual-lumen needle.

Abstract: According to embodiments, priming systems, methods, and devices are disclosed which allow medical treatment devices which pump fluid to be primed with minimal operator intervention and a high level of convenience. A blood circuit with a filter fitted with one or more air vents on a non-blood compartment is attached to a treatment system and priming fluid pumped slowly through the blood circuit in a loop. The source of fluid may be elevated, or the pumping may generate pressure, such that priming fluid is forced through the membrane of the filter and out the air vent(s). In embodiments, the vents are hydrophobic which prevent fluid from being ejected, so the priming system can nm without intervention.

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: A restraining device for a tubing connector assembly can include a resilient member having a generally U-shape with forked ends that curve toward each other. Each forked end can have a recess between tines thereof. Each recess can have a blind end. The resilient member can have a bend provided with an engagement bump. The engagement bump and forked ends can be aligned such that the engagement bump coincides with a line joining the blind ends. When a cylindrical connector assembly tube is placed in the recesses, the engagement bump is urged against a side of the connector assembly to thereby prevent inadvertent disconnection.

Abstract: An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

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: An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

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 bandage can be used to secure a needle to an access site so as to prevent unintended movement or withdrawal of the needle from the access site during administration of a treatment to a patient. After treatment, the needle can be removed by manipulating a portion of the bandage. Another portion of the bandage can be maintained in position over the access site during needle removal and can be used to promote clotting of the site after needle removal. The bandage may include a clotting agent, a hemostasis pad, and/or a clot-promoting structure. Additionally or alternatively, finger pressure can be applied to the access site through the bandage. For example, the bandage may include a viewing window without any adhesive to allow visual monitoring of the access site during treatment. Finger pressure may be applied to the viewing window and thereby to the access site during and after needle removal to encourage hemostasis.