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.

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: Blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration.

Abstract: One or more waste balancing systems may be used in a fluid circulating system for medical use. The fluid circulating system may be part of a blood treatment system for a patient suffering renal failure. A waste balancing system may include a pressure element operable to maintain a constant fluid pressure created by the combined weight of waste removed from a patient and replacement fluid for providing to a patient. Multiple evaluation characteristics or control parameters may be evaluated or controlled for safety and accuracy. At least part of the waste balancing system may be incorporated into a disposable cartridge.

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 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 or more waste balancing systems may be used in a fluid circulating system for medical use. The fluid circulating system may be part of a blood treatment system for a patient suffering renal failure. A waste balancing system may include a pressure element operable to maintain a constant fluid pressure created by the combined weight of waste removed from a patient and replacement fluid for providing to a patient. Multiple evaluation characteristics or control parameters may be evaluated or controlled for safety and accuracy. At least part of the waste balancing system may be incorporated into a disposable cartridge.

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 pressure measurement device isolates liquid, such as blood, from an intermediate fluid, such as air, by means of a diaphragm. The diaphragm is arranged between first and second chambers of respective first and second shells of a pressure pod body. The first shell has first and second ports, which are connected to the first chamber. The second shell has a measurement port with a connector in communication with the second chamber. A pressure transducer with a mating connector is directly connected to the measurement port connector to minimize the sealed volume between the diaphragm and the pressure transducer.

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: Blood treatment system and method for high rate hemofiltration ensures against pyrogenic patient reaction by providing various mechanisms for filtering replacement fluid to remove endotoxins and other safety features including detecting incorrect fluid administration.

Abstract: A sharp medical device is attached to a flexible element by a base of the sharp device. The base has a portion with a score line defining a position of predictable failure such that the base can be broken by applying a breaking moment at the score line to permit a user to separate the sharp device and the flexible element cleanly at the position of predictable failure. Various other embodiments are included, which disclose a similar effect.

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: Devices can use various features to prevent the disconnection of connectors used in medical treatments. For example, a disconnection prevention member can have ends which hold luer connectors such that a male luer connector is prevented from separating from a female luer connector. The member can thus prevent disconnection of luer connectors that are incompletely mated.

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: 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: 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 the treatment machine. Another is to provide a module with just the sensors near the access.

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: A configuration of a blood microtubular filter/dialyzer used in many kinds of renal replacement therapy systems can provide a highly effective mechanism for removing air from the blood circuit of such systems. Air is removed from an outlet header space of the filter avoiding the need for a bubble trap or settling chamber such as a drip chamber.

Abstract: A tubing set is disclosed that includes 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 can have a pumping portion for engagement with an infusate pump. The tubing set can also include a second line having first and second ends, the second line first end being attached to the first line between the first line pumping portion and the first line second end and the second line second end being configured for connection to the first line between the first line first end and the first line pumping portion. The tubing set can further include a check valve located in the second line, the check valve having a predetermined cracking pressure of at least 200 mm Hg.