Abstract: Systems, methods, and devices can detect a dangerous or adverse condition or anticipated condition that indicates an undesirable amount of electric current in a patient-connected tube providing fluid to a patient. The fluid flow to the patient is stopped responsive to the detection. Stoppage of fluid flow to the patient can reduce or prevent electric current in the fluid from reaching a patient, flowing through the patient to ground, and/or continuing to flow through the patient.

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: 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. The advantage of forming the batch before treatment is that the rate of filtering needn't match the rate of consumption during treatment which provides multiple benefits and liabilities to overcome, as discussed herein. Mechanisms for preparing pure water for infusion or medicaments are described such as elimination of chlorine and colloidal aluminum. Also various control mechanisms to help avoid contamination are describe.

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 low leakage current fluid heater and systems and methods thereof. The fluid heater has a configuration whereby a heating element is isolated from a fluid channel so as to leak into fluid passing through the channel an allowed amount of leakage current. Fluid passing through the fluid heater can be heated to a desired temperature. A controller can provide control signals to driver the fluid heater to the desired temperature and maintain the temperature at the desired temperature.

Abstract: A medical device has an interior for containment of fluids; an opening into the interior, an elastomeric wall comprising a fixedly placed, flexible barrier across the opening; and a retention wall positioned adjacent to a peripheral portion of the elastomeric wall. The retention wall defines a central opening and has a generally rigid retention zone surrounding the central opening, to engage and retain a connector tube which is advanced into the central opening to open a flow aperture through the elastomeric wall, for flow through the wall and connector tube. One of the retention zone and connector tube may be made of a material of sufficient hardness that material of the other engaging member is deformed by engagement therewith, which increases the strength of retention between the retention wall and the connector 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: 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 closure for a tubular access port in a medical fluid flow line or other container comprises a removable cap for enclosing and sealing the tubular access port. The cap has a closed end wall. The end wall carries an extending poker to facilitate the pushing of an antiseptic-carrying material into a lumen of the access port. The poker has an outer diameter that is less than the inner diameter of the access port. A method of using the poker is also described.

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: Systems, methods, and devices for preparation of water for various uses including blood treatment are described. In embodiments, fluid is passed through a first filtration step which is effective for creating purified water and a pair of ultrafilters placed at the outlet. The ultrafilters are separated by an intervening flow path to prevent grow-through from the outlet end upstream. In embodiments, a recirculation path with an air removing filter helps to eliminate air from the ultimate product water.

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: 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. The advantage of forming the batch before treatment is that the rate of filtering needn't match the rate of consumption during treatment which provides multiple benefits and liabilities to overcome, as discussed herein. Mechanisms for preparing pure water for infusion or medicaments are described such as elimination of chlorine and colloidal aluminum. Also various control mechanisms to help avoid contamination are describe.

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: Device and methods for separating a scab from a vascular access site are disclosed. The devices include providing a scab separation device having a point for initial separation of a portion of a scab from a patient's flesh, and a series of inclined surfaces leading from the point to lift and separate the scab from the access site. The scab separation device is provided with a cover so that the device is maintained as sterile. In a preferred embodiment, the scab separation device is provided as a set or assembly with a needle or needle set and, in a more preferred embodiment, the scab separation device cover is also used as a cover for a needle to maintain sterility both of an operative end of the separation device and of the 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: 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 tubular medical fluid flow set comprises a pressure sensing chamber connected in flow-through relation to fluid flow tubing of the set. The pressure sensing chamber defines a movable, flexible, impermeable diaphragm dividing the chamber into two separate compartments. The fluid flow tubing communicates with one of the compartments and is isolated from the other of the compartments. A port is carried on the chamber, the port having a seal therein, and communicating with the other of the compartments. Thus, the other of the compartments is hermetically sealed until the port is opened for connection with a pressure measuring device, to keep the flexible diaphragm in a desired, initial position prior to opening of the seal.

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.