Abstract: A filter membrane, methods of making such filter membrane and apparatus employing such filter membrane are disclosed, in which the filter membrane is a monolithic polymeric membrane that includes a polymeric filter layer including a micron-scale precision-shaped pores and a polymeric support layer that has a precision-shaped porous support structure for the filter layer. Several methods are disclosed for making such a membrane using micromachining techniques, including lithographic, laser ablation and x-ray treatment techniques. Several filter apparatus employing such a membrane are also disclosed.

Abstract: Systems and methods convey the blood through a gap defined between an inner surface that is located about an axis and an outer surface that is concentric with the inner surface. At least one of the inner and outer surfaces carries a membrane that consists essentially of either a hemofiltration membrane or a hemodialysis membrane. The systems and methods cause relative movement between the inner and outer surfaces about the axis at a selected surface velocity, taking into account the size of the gap. The relative movement of the two surfaces creates movement of the blood within the gap, which creates vortical flow conditions that induce transport of cellular blood components from the membrane while plasma water and waste material are transported to the membrane for transport across the membrane. Shear-enhanced transport of waste materials and blood plasma water results.

Abstract: Programmable, fluid pressure actuated blood processing systems and methods are used in association a blood separation device. The systems and methods employ a cassette, which contains several preformed, pneumatically actuated pump stations, several preformed fluid flow paths, and several preformed, pneumatically actuated valves in the fluid flow paths. The systems and methods also employ a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations.

Abstract: A multiple function pump station performs different on-line processing tasks. The pump station can be operated in one mode to draw blood from a donor can, in another mode, be operated to return blood to the donor. The pump station used to draw blood from a donor can also be used to perform subsequent blood processing tasks, such as mixing processing or additive fluids with the blood, or transfering a harvested blood component to a storage container, or finishing the processing of a harvested blood component, e.g., by passage through a filter to remove leukocytes.

Abstract: Blood component processing systems and methods are coupled to a blood component processing device. The systems and methods include a fluid circuit that comprises at least one fluid pressure actuated pump station, at least one fluid flow path communicating with the pump station, and at least one valve in the fluid flow path. A control module is sized and configured to interact with the fluid circuit. The control module includes an actuator to selectively apply fluid pressure to the pump station in concert with operation of the valve to pump fluid through the fluid flow path in response to a control program. A controller coupled to the control module includes the control program and a fluid circuit integrity test function.

Abstract: A biological suspension processing system is disclosed that may include a suspension treatment device for treating one or more components of a biological suspension, a first fluid flow path for introducing a suspension into the treatment device and a second fluid flow path for withdrawing a constituent of the suspension from the device. At least on microelectromechanical (MEM) sensor communicates with one of the fluid flow paths for sensing a selected characteristic of the fluid therewith. The MEM sensor may be located elsewhere, such as on a container or bag and communicate with the interior for sensing a characteristic of the fluid contained therein. A wide variety of characteristics may be sensed, such as flow rate, pH, cell type, cell antigenicity, DNA, viral or bacterial presence, cholesterol, hematocrit, cell concentration, cell count, partial pressure, pathogen presence, or viscosity.

Abstract: Blood processing systems and methods establish on line communication between a container and a source of blood containing leukocytes and platelets, such as a human donor. The systems and methods create a centrifugal field between the source of blood and the container that separates from the blood an unfinished suspension of platelets having a first physiologic characteristic different than the desired physiologic characteristic. The systems and methods pump the unfinished platelet suspension outside the centrifugal field through a finishing device. The finishing device changes the first physiologic characteristic to the desired physiological characteristic, thereby creating the finished platelet suspension. The systems and methods convey the finished platelet suspension from the finishing device directly into the container. The systems and methods function without interrupting the on line communication between the container and the source of blood.

Abstract: Automated systems and method for processing blood and other fluids are disclosed. The systems and methods utilize a disposable fluid circuit mounted on a re-usable hardware component or module. The system withdraws blood from a donor or patient, separates the blood into two or more components and further processes or treats the separated component.

Abstract: An apheresis system is disclosed which may include a separation chamber; a suspension flow path which communicates at one end with the separation chamber and includes a connector at the other end for connecting to a source of cellular suspension; an anticoagulant flow path which communicates at one end with the suspension flow path and includes a connector at the other end for connecting to an anticoagulant source; and a return flow path which communicates at one end with the separation chamber and communicates at the other end with a connector for connection directly to the suspension source or to the suspension flow path for returning one or more suspension components to the source. The anticoagulant flow path includes a flow restriction, such as an internal flow restriction, which limits the free flow of anticoagulants into the suspension flow path while preferably not completely stopping the flow of anticoagulant.

Abstract: Methods and apparatus for concentrating and recovering pathogens from a fluid other than blood are disclosed. The method includes concentrating the pathogens contained in the fluid by continuously feeding the fluid through one or more flexible chamber(s) and subjecting the chamber(s) to centrifugal forces. The concentrated pathogens may be re-suspended by shaking the chamber(s).

Abstract: A method and apparatus for filtering suspensions of medical and biological fluids, one aspect of which is separating a suspension comprising at least two types of particles which are differently sized or shaped and in which the first type of particle may be deformable at a relatively lower force and/or faster rate than the second type of particle. A filter member is provided having substantially precisely dimensioned pore sizes, with the pores being dimensioned to allow passage of the first type of suspended particle without distortion or only minimal distortion and passage of the second type of particle only with substantial distortion.

Abstract: A pneumatic pump manifold disposable system, configured as a cassette, is used for the purpose of red cell and plasma apheresis. The cassette integrates a separation device, manifold system, macro-aggregate filter, and five pumping chambers for the purpose of separating plasma and red cells from the whole blood. The cassette system, with the separation device directly attached without tubing, simplifies the loading of the disposable set into the hardware, and reduces the manufacturing complexity of the set. The system allows for plasma, plasma and red cells, or just red cells to be stored in long term storage containers after a procedure.

Abstract: A positive connection between a pipe and a ring inserted into the pipe, in particular between the housing of a ram boring device and a stop ring inserted into the housing, wherein the inside wall of the pipe has a convex groove consisting of a section of a surface of a sphere and the ring has a corresponding convex outer surface with the same radius, the inside wall of the pipe possessing at least one axial groove permitting insertion into the pipe or the outer surface of the ring possessing at least one flattened portion permitting insertion into the pipe, or the ring being axially divided into two or more preferably unequal segments.

Abstract: Bipolar electrosurgical scissors are disclosed having a pair of blades joined for relative movement in a scissor-like action between open and closed positions. The blades comprise a tissue contacting surface and first and second spaced apart electrodes extending along the surface. Current flow between the first and second electrodes of each blade and between each blade to promote hemostasis in tissue contacting the surface.

Abstract: A flexible, three-dimensional container is made by a prescribed vacuum-molding and heat sealing process. The container possesses a precise, defined geometry before and during use. The container is formed from first and second walls. The first wall has a planar area and a vacuum-molded cavity area drawn out of the plane of the planar area into a predefined three-dimensional geometry. A second wall overlies the first wall to close the cavity area and thereby forms an interior compartment. A thermal seal joins the two walls together. The seal is formed by heating the second wall and the first wall in the planar area, while assuring that the cavity area of the first wall is not subject to heating and possible deformation of its precise vacuum-molded geometry.

Abstract: A blood component separating device comprises a centrifuge bowl adapted for rotation about its axis in a centrifuge. The bowl defines an outer arcuate wall plus an inner circumferential wall, spaced from the outer wall, to define a arcuate slot adapted for receiving blood components. Access tubing is adapted for communication with the slot. Preferably, an elongated, flexible, collapsible inner liner is provided in the slot. Individual access tubing also may communicate with an elongated container interior between the ends of the elongated, collapsible container. Furthermore, a portion of the slot may define the shape of an outwardly extending spiral, to provide an increasing gravitational field upon fluids therein as the fluid moves along the slot.

Abstract: A blood component separating device comprises a centrifuge bowl adapted for rotation about its axis in a centrifuge. The bowl defines an outer arcuate wall plus an inner circumferential wall, spaced from the outer wall, to define a arcuate slot adapted for receiving blood components. Access tubing is adapted for communication with the slot. Preferably, an elongated, flexible, collapsible inner liner is provided in the slot. Individual access tubing also may communicate with an elongated container interior between the ends of the elongated, collapsible container. Furthermore, a portion of the slot may define the shape of an outwardly extending spiral, to provide an increasing gravitational field upon fluids therein as the fluid moves along the slot.

Abstract: A plastic composition is disclosed which has particular application in the manufacture of blood bags and other medical products. The composition has anti-hemolytic effects when used in the storage of red blood cells. In connection with one aspect of the present invention, the plastic composition comprises the combination of a non-PVC plastic and a selected quantity citrate ester sufficient to suppress hemolysis of red blood cells. The non-PVC material is preferably a polyolefin copolymer. Materials other than citrate ester may also be used with polyolefin as a hemolysis suppressant.

Abstract: A flexible plastic container made from a flexible, autoclavable, non-PVC polymer composition capable of suppressing the hemolysis of red blood cells. The polymer contains a material selected from the group consisting of either triethylhexyltrimellitate (TEHTM) and citrate ester. In the preferred embodiment, the non-PVC plastic is comprised of a polyolefin copolymer containing a central block of ethylene and butylene units with terminal blocks of polystyrene.

Abstract: Thin-walled catheters are provided which have an elongated fuseless polymeric tube that is made from a single tube of extruded polymer. The elongated fuseless polymeric tube includes a body portion that had been subjected to a high temperature zone in order to solid state polymerize and enhance the mechanical stability, burst strength and kink resistance of the body portion. Also included is a tip portion of the elongated fuseless polymeric tube which was subjected to a low temperature zone to retain the initial properties of extruded polymer.