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: A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn't match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.

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: 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 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: 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 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: 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 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: 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.

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: 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 first connector of a connector assembly of a sterile batch container can be unsealed. The connector assembly can be attached to a filling port of the sterile batch container and can have a sterile filter arranged between the filling port and the first connector. The first connector can be coupled so as to receive produced purified water. A transmembrane pressure can be monitored across the sterile filter while flowing the purified water through the connector assembly into the sterile batch container so as to provide a sterile fluid stored therein. The connector assembly can be detached from the filling port of the sterile batch container. After the detaching, the sterile batch container can be coupled to the blood treatment system. In response to a change in the transmembrane pressure exceeding a predefined level, an alarm signal can be generated.

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 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.

Abstract: A pressure measuring device has tubing with an inline “pillow” portion that is more flexible than the tubing portion. The pillow portion may be created by heating a portion of a length of medical tubing and forcing air into the heated portion to expand, and thin, its walls. The tubing and pillow portion may be used in a negatively pressurized portion of a blood circuit such as an arterial return line. An assembly of interleaved support members adhesively bonded to the pillow portion holds the pillow portion in an expanded state even under negative pressure. Further, when the pillow portion tries to collapse, the interleaved support members compress a strain gauge to provide a pressure signal corresponding to the negative pressure exerted by the fluid therewithin.

Abstract: A blood processing system includes a flow reversing device with at least an air sensor in the venous line located near the patient. During treatment, blood flow is reversed to cause air to infiltrate the blood lines if any disconnections or breaks in the blood line are present. One means for placing the sensor close to the patient is to provide the flow switching device aid sensors in a small lightweight module that can be located close to the treatment machine. Another is to provide a module with just the sensors near the access.

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.

Abstract: A first connector of a connector assembly of a sterile batch container can be unsealed. The connector assembly can be attached to a filling port of the sterile batch container and can have a sterile filter arranged between the filling port and the first connector. The first connector can be coupled so as to receive produced purified water. A transmembrane pressure can be monitored across the sterile filter while flowing the purified water through the connector assembly into the sterile batch container so as to provide a sterile fluid stored therein. The connector assembly can be detached from the filling port of the sterile batch container. After the detaching, the sterile batch container can be coupled to the blood treatment system. In response to a change in the transmembrane pressure exceeding a predefined level, an alarm signal can be generated.

Abstract: A tubing set is disclosed including a first line having first and second ends, a bag spike at the first end configured for connection to a source of infusate, and a connector at the second end configured for connection to a blood line. The first line has a pumping portion for engagement with an infusate pump. The tubing set includes a second line having first and second ends, the first end being attached to the first line between the first line pumping portion and the first line second end and the second end being configured for connection to the first line between the first line first end and the first line pumping portion. The second line second end is configured for connection to the first line by a dual lumen spike.