Abstract: The present invention provides a method for testing a blood unit for viral contamination without rendering the blood unit unusable for therapeutic applications. The method comprises the steps of: removing and collecting from a blood unit a majority of the leukocytes present therein with a leukocyte filter; and using the leukocytes collected in and on the filter to test the blood unit for viral contamination. The present invention also provides a method for validating viral inactivation processes.

Abstract: Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: A protective shield for a blood sampling unit that is movably engaged to an adapter having a needle attached. The shield attaches to a tube holder when the needle is covered by the shield. Longitudinal grooves on the adapter guide the shield between a first position, covering the needle, and a second, position, exposing the needle. The shield can be locked in either the first position or the second position. The blood sampling unit is safely disassembled or reassembled when the needle is covered by the shield. In an embodiment of the invention, a tip protector, removably attached to the adapter, extends through the length of the tube holder to prevent needlesticks. The blood sampling unit and the tube holder can be assembled and disassembled when the tip protector is attached to the adapter, covering the needle. The tip protector is removed during a clinical procedure and then replaced after the clinical procedure is finished.

Abstract: A surgical drape is described which includes a pouch having one embodiment a one-piece construction and formed with a single seam. An edge of the pouch may be extended to create a concave surface to control and contain fluids during a surgical procedure. Once formed or shaped into the pouch and the edge sealed, the sheet has a front portion, a back portion, an upper back edge in the back portion for placement relatively near the surgical site, and an upper front edge on the front portion, which in the final configuration, is located away from the upper back edge. The upper back edge and the upper front edge together define the opening in the pouch having a circumference. Additionally, the length of the upper front edge is preferably greater than the length of the upper back edge.

Abstract: A system and method of separation of therapeutic components from blood. The system includes a dual member centrifuge and a disposable single use fluid transfer set. The set includes an elongated flexible separation chamber having an input port, a separated component output port and a residual fluid output port. The input port and the separated component output ports are located at opposite ends of the elongated separation chamber. The centrifuge includes a receiving chamber with a selectively formed annular slot therein. The separation chamber is positioned in the annularly shaped slot and rotated at a predetermined rotational velocity. Fluids such as whole blood flows through the separation chamber and are separated into various therapeutic components such as platelet rich plasma and residual concentrated red blood cells. Platelet rich plasma can be drawn off as the separated therapeutic component. An alternate two part transfer set provides for highly efficient platelet pheresis.

Abstract: A drug delivery device (250) is provided for coupling a container (260) including a beneficial agent (262) to the device (250). The device (250) includes a substantially hollow member for housing a solution (256) wherein the hollow member includes an upper section (254) having flexible walls and a lower section (252) having substantially rigid walls. A spike (258) extends from the lower section (252) to provide fluid communication between an interior of the device (250) and the container (260). To this end, the beneficial agent (262) mixes with the solution (256) forming a mixture for administration to a patient. A cannula (266) and a plunger (264) are further provided for administration of the mixture (270) to the patient.

Abstract: A peristaltic pump includes a pump race for receiving a flexible tubing. A rotatable pump rotor carries at least one roller for contacting the tubing. A roller locating mechanism moves the pump roller between a retracted position free of contact with the tubing and an extended position making operative contact with the tubing. A controller operates the pump (i) in a pumping mode, during which the rotor is rotated with the roller located in its extended position, and (ii) in a valving mode, during which rotation of the rotor is terminated and the roller is selectively moved between its extended position to block fluid flow through the tubing and its retracted position to permit fluid flow through the tubing. The pump thus provides a peristaltic pump pumping function, as well as serving as a valve element.

Abstract: A medical infusion pump (10) using a pump chamber cassette (86) has a housing (20,22) defining a pump chamber cassette receptacle (84) and a pump driving mechanism (250) for propelling liquid through the pump chamber cassette. A door (50) holds the pump chamber cassette (86) within the cassette receptacle (84) in an operative position relative to the driving mechanism (250). The cassette includes an elastomeric conduit (132), a frame (134) and clips (146,148) for attaching the elastomeric conduit (132) to the frame (134) for holding the elastomeric conduit (132) in a select position relative to the pump driving mechanism (250) of the infusion pump upon placement of the cassette (86) in an operative position relative to the pump driving mechanism (250).

Abstract: A peristaltic pumping apparatus includes a peristaltic pump rotor and pump race. A pump tube cassette includes a body for supporting a flexible tubing loop in an erect, outwardly bowed position for placement within the pump race and for removal from the pump race. A surface juxtaposed the peristaltic pump rotor and race carries a gripping jaw assembly. The gripping jaw assembly opens to receive the pump tube cassette body as the body is moved toward the pump rotor to place the tubing loop within the pump race. The gripping jaw assembly closes to secure the pump tube holder body on the surface in an orientation in which the tubing loop lies within the pump race for engagement with the peristaltic pump rotor.

Abstract: Dual-skinned membranes are provided useful as one-way or rectifying membranes which reduce back filtration of solute molecules in dialysis and which improve nutrient supply and product recovery in membrane bioreactors. The membranes are dual-skinned polymeric materials preferably in the form of hollow fibers. The membranes have skins of polymer on the opposite sides with differing permeability to solutes and sieving coefficient characteristics. The skin on each side have pores that are invisible at 10,000 times magnification. A microporous structure between the skins contains pores capable of retaining solutes in a molecular weight range of about 5000 to 200,000 in an increased concentration between the interior and the exterior skins. Improved dialysis devices are formed by using bundles of the hollow fiber membranes as a dialysis member having rectifying properties.

Abstract: An ambulatory infusion pump system provides a continuous source of liquid medication to an ambulatory patient. The ambulatory infusion pump system includes a liquid medication reservoir (64) and a conduit (16) for conveying liquid medication from the reservoir to the patient. An ambulatory infusion pump (10) pumps liquid medication from the reservoir (64) to the patient (14) by manipulation of the conduit (16). A case (12) is provided for the ambulatory infusion pump (10) and the liquid medication reservoir (64). The case (12) includes a first chamber (440) receiving the ambulatory pump (10) and a second chamber (442) receiving the liquid medication reservoir (64). The first and second chambers are maintained in a juxtaposed position. An outlet through the case receives the conduit (16).

Abstract: A bone biopsy needle assembly includes an elongated tubular cannula having an axially extending lumen therethrough. A guide is provided to facilitate insertion of a probe into the cannula for sample removal. The guide has a molded shape with an elongated dimension having first and second ends. A cylindrical opening extends through the length of the elongated dimension and has a diameter substantially equal to that of the interior lumen of the cannula. A flared outward enlargement of the cylindrical opening at each of the first and second ends provides for easy alignment of one of the ends with the distal end of the cannula and the other end forms a guide for insertion of a probe into the distal end of the cannula for removal of the biopsy specimen.

Abstract: A catheter device incorporating combined ultrasound ablation and balloon dilation components. The catheter device generally comprises an elongate catheter body having proximal and distal ends and an outer surface. Disposed on the outer surface of the catheter body is a dilation balloon. At least one balloon inflation lumen fluidly connects the proximal end of the catheter body to the dilation balloon to permit injection of inflation fluid into the dilation balloon. Extending longitudinally through the catheter body is an ultrasound transmission member having a proximal end and a distal end, with the proximal end being connectable to an ultrasound transducer such that ultrasonic energy will pass through the ultrasound transmission member to the distal end thereof. In alternative embodiments of the present invention, there are provided catheter devices incorporating combined ultrasound ablation and laser ablation components as well as combined ultrasound ablation and atherectomy ablation components.

Abstract: A process for purifying Factor VIII:C comprising contacting an immobilized antibody specifically binding a Factor VIII:C with Factor VIII: C, desorbing Factor VIII:C from the antibody which had adsorbed it, eluting Factor VIII:C from the presence of the antibody, passing the eluted Factor VIII:C through an affinity region capable of binding the Factor VIII:C, binding the Factor VIII:C in the affinity region and passing contaminants through said region, and eluting the purified Factor VIII:C.

Abstract: A patient fluid collection system is disclosed which includes a fluid collection reservoir, a cover for the reservoir and a liner within the reservoir comprising an enlargeable or expandable wall portion such that the wall portion may expand if the liner fills with fluid. An anti-reflux system is also disclosed as well as a new tandem tube and a new connector.

Abstract: A method of making a peelable tube assembly (76,80,84,88) having a plurality of adjacent tube portions (62) joined by intermittent breakable webs (72) of plastic allowing the individual portions (62) to be peeled from the tube assembly, including providing a plurality of plastic tube portions (62) each having a tube wall (66) defining a flow passage (70). The tube portions (62) are aligned adjacent to one another in a die assembly (12) having compression channels (30). Narrow confined flow chambers (32) are defined between adjacent portions (62) of the tube walls (66), and between the ends of the tube walls (66). The tube portions (62) are radially compressed without occluding the flow passage (70). Small compressed portions of the tube walls (66) proximate the flow chambers (32) are heated and plasticized.

Abstract: The present invention relates to anti-viral materials. These anti-viral materials have a pool of anti-viral agents acting in cooperation with certain plasticizers to maintain and increase the anti-viral agents efficacy. These anti-viral materials may be used to make surgical gloves, condoms, surgical clothes, surgical operative fields, finger stalls, aprons, bibs and caps.

Abstract: A cassette serves in association with one or more peristaltic pumps to centralize pumping, valving, and pressure sensing functions. The cassette includes a housing having first and second pump ports. A flexible tubing loop extends between the first and second pump ports outside the housing for engagement with an external peristaltic pump element. A liquid port on the housing attaches to a length of tubing that also extends outside the housing. Liquid passages within the housing that establish communication among the liquid port, the first pump port, and the second pump port. Valve stations formed within the housing are responsive to the application of external force for controlling liquid flow through the liquid passages. A sensing chamber is formed within the housing along at least one liquid passage. The sensing chamber transmits information regarding liquid pressure present within the one liquid passage to an external sensing element.