Abstract: Improved extracorporeal blood processing methods and apparatus are disclosed. In one aspect of the invention, an extracorporeal method for the collection of platelets and red blood cells, and if desired plasma, is provided, wherein the collection of platelets and red blood cells may occur in differing time periods utilizing the same blood processing vessel. The flow of blood to the blood processing vessel and return of uncollected blood components may be provided via a single needle, wherein blood is removed and returned to a donor/patient during alternating blood removal and blood return submodes. Prior to red blood cell collection, a set-up phase may be carried out during which a predetermined hematocrit and AC ratio is established.

Abstract: An extracorporeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Abstract: A method and apparatus in which the blood flow in a fistula is determined by comparing the property of blood entering the fistula to the property of blood being withdrawn from the fistula as the blood in the fistula flows in the direction which is the reverse of the predominant flow. A property marker fluid is injected into the blood entering the fistula in order to alter the property of the blood. Aseptic conditions are maintained during the reversal of the blood flow by maintaining a closed blood loop exterior to the patient. The blood loop closure is maintained by reversing the action of the pump which induces blood flow in the closed blood loop.

Abstract: An extracorporeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Abstract: The instant invention relates to a method and the apparatus for collecting a hyperconcentrated platelet product. A fluid containing platelets and other particles flows into a fluid chamber at a flow rate. The flow rate of the fluid is selected to retain the majority of the platelets in the fluid chamber in a saturated bed. The platelets are collected from the fluid chamber without collecting the other particles to form a hyperconcentrated other particle reduced platelet product.

Abstract: A capped connector for a tubing set and/or medical equipment is provided. The connector comprises a hollow tube having a cap securing leash pivotally attached to its exterior. A cap is pivotally attached to the leash's opposing end. The leash is designed to hold the cap in an orientation that facilitates automated capping while allowing the cap and leash to be rotated away from the connector opening when the cap is not is use.

Abstract: A gas-permeable, pathogen-resistant seal for sealing packages containing medical products is described. The seal comprises a labyrinthine passage, preferably formed in two dimensions, through which bacteria cannot pass. The seal functions to block the passage of bacteria without an additional bacteria blocking material. A method for making the subject seal using heat sealing techniques is also described.

Abstract: A timing device for coordinating a presentation includes a master timer with a timing initiator, a programmable master sequencer responsive to the timing initiator, a master sensory alarm responsive to the sequencer, a master alarm silencer, and a communication transmitter responsive to at least one of the timing initiator and the master sequencer. The timing initiator begins operation of the master sequencer. The master sequencer actuates the master sensory alarm at at least one predetermined time after initiation. The communication transmitter sends a signal when the timing initiator beginning operation of the master sequencer or at a predetermined time after initiation of operation of the master sequencer. At least one slave timer, and optionally a plurality of slave timers, is provided.

Abstract: A flow rate of a fluid flowing in a tube is quantitatively determined by altering the electrical conductivity of the fluid by injection of a bolus of saline. The electrical conductivity of the altered conductivity is measured over the time it takes the altered conductivity fluid to pass a conductivity measuring location. The measured conductivity is integrated over the time it takes to pass the conductivity measuring location. The integral is interpreted to determine the flow rate.

Abstract: A method and apparatus for maximizing the total amount of blood processed during an apheresis procedure by optimizing the concentration of anticoagulant in a donor/patient and the associated extracorporeal tubing set is provided. A simplified model of anticoagulant accumulation in a donor/patient's body is used to calculate an optimal anticoagulant infusion rate profile to the donor/patient during a blood processing procedure. A maximum acceptable anticoagulant concentration in the donor/patient acts as an upper limit on the rate at which anticoagulant may be infused to the donor/patient using the optimized infusion rate profile. A minimum acceptable anticoagulant level acts as a lower limit in optimally controlling the anticoagulant concentration in the extracorporeal tubing set.

Abstract: A combination pressure pod and access site apparatus is suitable for use in a medical tubing set. The combination pressure pod and access site comprises a pressure sensing chamber and a measured fluid chamber separated by a pressure transmissive diaphragm. An access site having a needle or needle-less septum is in fluid communication with the measured fluid chamber and permits and withdrawing fluids from, the measured fluid chamber through the access site. One or more of the combination pressure sites and access sites may be provided in a simplified blood tubing set for an extracorporeal blood treatment apparatus, such as a hemodialysis apparatus.

Abstract: A method and apparatus for maximizing the total amount of blood processed during an apheresis procedure by optimizing the concentration of anticoagulant in a donor/patient and the associated extracorporeal tubing set is provided. A simplified model of an anticoagulant accumulation in a donor/patient's body is used to calculate an optimal anticoagulant infusion rate profile to the donor/patient during a blood processing procedure. A maximum acceptable anticoagulant concentration in the donor/patient acts as an upper limit on the rate at which anticoagulant may be infused to the donor/patient using the optimized infusion rate profile. A minimum acceptable anticoagulant level acts as a lower limit in optimally controlling the anticoagulant concentration in the extracorporeal tubing set.

Abstract: An method and apparatus for determining a degree of occlusion in the tubing loop disposed in the raceway of a peristaltic pump. An electrical circuit is formed in tubing loop by filling the loop with an electrically conductive fluid, such as blood, and electrically connecting the inlet portion to the outlet portion of the tubing loop. An excitation coil, which encircles a portion of the tubing loop, induces an alternating current in the tubing fluid. A sensing coil, also encircling a portion of the tubing loop, senses the induced current. The degree if occlusion in the tubing loop is correlated to the magnitude of the sensed current. The degree of occlusion may be adjusted, in response to the determined occlusion, while the pump is in operation using an occlusion adjuster.

Abstract: An apparatus for minimizing trauma to a medical fluid while transporting the medical fluid from a surgical wound by reducing the air to fluid interface during transport. The apparatus includes a suction wand for collecting medical fluid and tubing for transporting the medical fluid to a reservoir. The reservoir repeatedly accumulates the medical fluid and discharges it in a bolus when a predetermined volume is achieved. The reservoir comprises a fluid inlet, a fluid outlet, and a gas outlet. A siphon is disposed inside the reservoir for removing the bolus of medical fluid once the predetermined fluid volume is accumulated. The siphon includes a first end for suctioning the medical fluid and a second end exiting the reservoir through the fluid outlet, thereby defining an external siphon length. A pump is attached to the second siphon end to provide suction to the system.

Abstract: A method and system are disclosed for more accurate administration of a composition being infused into a body fluid having formed elements. The improved accuracy is due to a correction factor that corrects for the relative impermeability of the formed elements to the infused composition. In one embodiment, the infusion system is a cardioplegia system in which a controller receives information pertaining to the hematocrit and initial blood potassium concentration and adjusts blood flow rate and crystalloid (KCl) solution flow rate so as to obtain the desired resulting potassium concentration in the cardioplegia. The invention further includes an infusion system that comprises a controller which uses an equation that relates the correction factor to an index of formed elements in the body fluid, such as the hematocrit.

Abstract: A method and apparatus for preventing accidental manual rotor reversal in a peristaltic pump is provided. A peristaltic pump may be provided with a hand crank or the like to drive a rotor assembly of the pump manually in the event of failure of the electric motor drive of the pump. An indicator may provide information to the pump operator to inform the operator of the direction in which the pump was rotating when last driven by the electric motor. Further an alarm device may alert the operator when the operator is attempting to rotate the pump in the direction opposite the direction in which the pump was rotating when last driven by the electric motor or the direction last selected by the operator before loss of power.

Abstract: A flow rate of a fluid flowing in a tube is quantitatively determined by altering the electrical conductivity of the fluid by injection of a bolus of saline. The electrical conductivity of the altered conductivity is measured over the time it takes the altered conductivity fluid to pass a conductivity measuring location. The measured conductivity is integrated over the time it take to pass the conductivity measuring location. The integral is interpreted to determine the flow rate.

Abstract: Improved elastomeric materials useful for medical and therapeutic device applications, such as penetrable septa, are described. In one aspect, the materials are deeply cleaned with solvent to significantly lower levels of undesirable organics. In another aspect, internally lubricated elastomer compositions compatible for use in medical and therapeutic device applications are provided. The lubricating fluid is present in the composition from about 0.5% to 50% by weight, and is initially substantially homogeneously dispersed in the elastomer. The fluid can be integrated into the elastomer by a solvent infusion method. In another aspect an internally lubricated thermoplastic septum, having an appropriate hardness for resealability with multiple penetrations, is provided.