Abstract: A method of sterilizing and drying a dialyzer or other device, wherein a vacuum drying phase is interrupted by interspersed pulses of air or other gas. The pulses lessen the evaporative cooling effect, to thereby reduce differential shrinkage that can structurally damage the dialyzer.

Abstract: A filter device made of less expensive material than comparable filter devices heretofore has basic filter components plus some unique design aspects and an additional ring component. The ring provides an interface inside the filter which enables the potting compound to adhere to the filter and create a seal between a first and second fluid compartment within the filter. An embedded region of the ring possesses a detailed geometry which helps ensure that a delamination would be localized and unable to propagate from the first to the second compartment, maintaining the structural integrity of the filter device. To ensure that the sealing interface remains intact and free from delamination, the ring is subjected to a surface treatment, which modifies the surface energy of the ring. This modified surface energy of the ring allows the hydrophilic potting compound to more effectively bond to the modified hydrophobic ring.

Abstract: A dialyzer design that includes a potting material encasing a microfiber bundle in each end of a cylindrical body. The potting material is set by spinning the dialyzer in a centrifuge to force the potting material to the ends of the dialyzer interior chamber, where it sets with a non-planar surface. Dialysate fluid distribution rings define a space between the dialyzer interior chamber and dialyzer inlet and outlet ports, and laterally support the microfiber bundle against the dialysate fluid flow pressure. The dialysate fluid distribution ring circumferential edge substantially conforms to the non-planar potting material surface, to ensure that the lateral support to the microfiber bundle is constant, thereby lessening distortion, rupturing and obstruction of the microfibers.

Abstract: This invention utilizes a connector holding device to prevent the accidental disconnection of the two halves of a connection device for a fluid connector system.

Abstract: In a medical device, a Tx Clock Button is presented on a graphics display overlain with a touch screen which allows an operator to control multiple functions of the medical device. Various parts of Tx Clock Button may be displayed in different colors, and based on the state of treatment at a given time and in response to the operator touching Tx Clock Button, the colors may change to visually indicate a change in state. When the Tx Clock Button is touched for the first time after a new patient has been selected, multiple functions, times, displays, parameters, and alarms of the medical device are initiated. When the Tx Clock Button is touched for the second time, various ones of the multiple functions, times, displays, parameters, and alarms may be suspended. A third touch of the Tx Clock Button may resume the suspended items.

Abstract: An improved flow control device for regulating the flow of liquid or gas through a length of flexible-conduit using a generally enclosed rack and pinion assembly engaged by an external slidable assembly or switch. The case has a lower rack with a surface supporting a length of flexible conduit, opposing walls, and an upper surface. The lower rack has at least one rack track along which a pinion gear assembly may be engaged and rotated. The pinion gear assembly has a cylinder shaft capped on at least one end by a pinion gear with radiating teeth. The pinion gear assembly can be rotated along a portion of the flexible conduit, compressing it at one or more positions. Operation of the flow control device can be accomplished using a single hand, and the case remains enclosed without subjecting the pinion gear assembly to an external environment.

Abstract: A method for manufacturing and using a dialysis collection bag, and the dialysis collection bag itself. A collection bag is fabricated with a sterilization tablet therein, having a soluble coating over a sterilization agent. When the collection bag is filled with used dialysis solution at the completion of the dialysis therapy, the soluble coating dissolves over a known period of time such as about 30 minutes. The delayed dissolution allows time to take a specimen sample of the unadulterated used dialysis solution. When the dissolution of the coating is completed, the tablet releases the sterilization agent to sterilize the used dialysis solution, so that pathogens are destroyed to prevent the transmission of disease in the event the collection bag is disposed of improperly.

Abstract: An antimicrobial tubing connector for medical procedures, especially for extracorporeal connections as in peritoneal dialysis and hemodialysis tubing sets. A male portion includes a central tube surrounded by a sleeve radially spaced apart from the central tube to define an annular space. A mating female portion includes a tubular body which receives the central tube of the male portion and which is received by the annular space. A set of O-ring seals and mating threads produces a secure fluid-tight connection. An antimicrobial agent such as silver is deposited on one or more of several surfaces, preferably by a durable process such as ion assisted deposition, to prevent touch contamination. Either or both of the male and female portions may be capped with a separate cap, which may also receive the antimicrobial agent.

Abstract: A method for manufacturing and using a dialysis collection bag for peritoneal dialysis treatment, and the dialysis collection bag itself. A collection bag is fabricated with a sterilization tablet therein, having a soluble coating over a sterilization agent. When the collection bag is filled with used dialysis solution at the completion of the dialysis therapy, the soluble coating dissolves over a known period of time such as about 30 minutes. The delayed dissolution allows time to take a specimen sample of the unadulterated used dialysis solution. When the dissolution of the coating is completed, the tablet releases the sterilization agent to sterilize the used dialysis solution, so that pathogens are destroyed to prevent the transmission of disease in the event the collection bag is disposed of improperly.

Abstract: The present invention includes a method and apparatus for the testing the integrity of a dialyzer prior to use. The dialyzer is tested on the same hardware used for the treatment of dialysis. The dialysate and blood sides of the dialyzer are primed in the normal manner. The blood and saline lines are clamped while the venous line is vented to the atmosphere. The ultrafiltrate flow rate is increased until the blood side fluid is ultrafiltered. The dialysate side is monitored for pressure increases. If the pressure does not increase, the test fails.

Abstract: An antimicrobial tubing connector for medical procedures, especially for extracorporeal connections as in peritoneal dialysis and hemodialysis tubing sets. A male portion includes a central tube surrounded by a sleeve radially spaced apart from the central tube to define an annular space. A mating female portion includes a tubular body which receives the central tube of the male portion and which is received by the annular space. A set of O-ring seals and mating threads produces a secure fluid-tight connection. An antimicrobial agent such as silver is deposited on one or more of several surfaces, preferably by a durable process such as ion assisted deposition, to prevent touch contamination. Either or both of the male and female portions may be capped with a separate cap, which may also receive the antimicrobial agent.

Abstract: A method for manufacturing and using a dialysis collection bag, and the dialysis collection bag itself. A collection bag is fabricated with a sterilization tablet therein, having a soluble coating over a sterilization agent. When the collection bag is filled with used dialysis solution at the completion of the dialysis therapy, the soluble coating dissolves over a known period of time such as about 30 minutes. The delayed dissolution allows time to take a specimen sample of the unadulterated used dialysis solution. When the dissolution of the coating is completed, the tablet releases the sterilization agent to sterilize the used dialysis solution, so that pathogens are destroyed to prevent the transmission of disease in the event the collection bag is disposed of improperly.

Abstract: Apparatus for administering dialysis, including a separable tubing coupling (32). The tubing coupling (32) consists of a hollow cylindrical element (42, 44) insertable into the lumens of the distal and proximal regions of the fluid delivery tube (16), and has a scored circumference at which the coupling can be broken-off by application of an adequate bending force. The device allows rapid and reliable disconnecting of the patient from the dialysis apparatus, without the need for scissors or a knife to be employed.

Abstract: A system for packaging and using granulated solid dialysate concentrate. A bag is constructed to hold granulated or powder concentrate, having a V-shaped bottom with an access port in the bottom. Water is flowed through the access port and into the bag using suitable water control means. The incoming water lifts and suspends the granules or powder in a turbulent flow, thereby filling the container simultaneous with dissolving the granules or powder. The water with dissolve concentrate then constitutes the dialysis solution and is ready for use or transfer to a dialysate delivery machine.

Abstract: A tubing set for performing peritoneal dialysis and a method of operating the same. The tubing set includes elements for administering CCPD as well as elements for administering CAPD wherein preferably the CCPD and CAPD elements share a common reservoir bag and solution bags. The two sets of elements are separable by a releasable coupling. The CCPD elements may include multiple patient connectors in series to allow for multiple separate CCPD therapies. The solution bag and drain bag are separable from the other elements so that the empty solution bag from one tubing set can be used as the drain bag for the next tubing set.

Abstract: Apparatus for administering dialysis, including a separable tubing coupling (32). The tubing coupling (32) consists of a hollow cylindrical element (42, 44) insertable into the lumens of the distal and proximal regions of the fluid delivery tube (16), and has a scored circumference at which the coupling can be broken-off by application of an adequate bending force. The device allows rapid and reliable disconnecting of the patient from the dialysis apparatus, without the need for scissors or a knife to be employed.

Abstract: A method and apparatus for administering dialysis including a breakable tubing coupling is provided wherein the tubing coupling is a hollow cylindrical element insertable into the lumens of distal and proximal sections of a fluid delivery tubing system, the breakable tubing coupling having a scored circumference on which the coupling can be broken and separated by application of a bending force. The breakable tubing coupling is suitable for medical applications including peritoneal dialysis tubing administration set utilization for administering fluid from fluid containers into a patient's peritoneal cavity through a peritoneal catheter and out of the peritoneal cavity and into a drain container wherein the tubing administration set having a tubing supply leg and a tubing drain leg requires means for separating the peritoneal catheter following dialysis at a predetermined location along the tubing path.