Abstract: Methods for treating glutaraldehyde-fixed collagenous tissues to mitigate their propensity for subsequent calcification and to improve durability. Collagenous tissues which have been harvested and cross-linked by glutaraldehyde are exposed to a carboxyl activating agent to convert the free carboxyl (COOH) groups of the collagen molecules to activated carboxyl moieties (e.g., o-acylisourea). Thereafter, the collagenous tissue is exposed to a compound capable of reacting with the activated carboxyl moieties (e.g., o-acylisourea) to form non-carboxyl side groups. Monofunctional and multi-functional amines are examples of compounds which may be utilized to react with the activated carboxyl moieties to form such non-carboxyl side groups. Thereafter, the collagenous tissue is again exposed to glutaraldehyde. If the non-carboxyl side groups have functional amino groups (NH.sub.

Abstract: An extracorporeal blood oxygenation system comprising an integrated blood pump/heat exchanger/membrane oxygenator assembly which is mountable upon, and engageable with, a separate motor/drive assembly. The blood pump of the system incorporates a novel axial/centrifugal impeller assembly. An optional blood reservoir may be incorporated into the system to receive and contain venous return and/or surgical site blood. Also, an optional arterial filter may be incorporated into the system for filtering the oxygenated blood before the blood is returned to the patient. The pump/heat exchanger/membrane oxygenator component is preferably constructed such that heat exchange fluid which is being infused into the heat exchanger will pass through and/or in contact with a portion of the membrane oxygenator so as to further maintain the temperature of blood as it passes through the membrane oxygenator.

Abstract: Methods and devices for separating leukocytes from a leukocyte contaminated blood fraction by use of a rotating membrane filter apparatus. The invention includes methods/devices for preparing substantially leukocyte free platelet concentrate for therapeutic use. The devices of the invention include a rotating membrane filter apparatus for leukocyte separation as well as tubing harness/component systems (FIGS. 2a, 2b, 2c) useable in connection with automated apheresis instruments.

Abstract: A method and device for reducing the size of tissues and/or other materials contained within an intracorporeally positioned organ or artificial containment sac. In one embodiment, the device comprises an elongate cutting tool having a rotatable cutting head or impactor positioned on the distal end of the tool and, optionally, having one or more aspiration/infusion lumens extending longitudinally through the elongate shaft of the tool. In a second embodiment, the device may comprise (a) a separate guide/aspiration/infusion cannula initially insertable into the organ or sac and (b) a separate elongate cutting device which is insertable through and extractable from the prepositioned guide/aspiration/infusion cannula. An automatically deployable protective assembly may be positioned at the distal tip of either embodiment of the device so as to form a protective cage around the rotatable cutting head or impactor.

Abstract: A device, system and method for preventing unwanted movement or shifting of drums or containers stored in groups of two or more. A core member is positioned intermediate, among or between the drums or containers and at least one pressure exerting member or strap is utilized to urge the drums or containers inwardly into direct abutment with the core member. The core member may be specifically configured such that the individual drums or containers will nest or seat firmly against the core member. The pressure-exerting member may comprise any suitable type of pressure-exerting apparatus or article including strap(s), band(s), plastic shrink wrapping, cable, chains, etc. . . . The core member may be formed in multiple segments or may be specifically configured to accommodate tapered, angled or odd shaped drums or containers having sidewalls which are not perfectly vertical.

Abstract: A method and device for removing a first guide catheter and replacing the first guide catheter with a second guide catheter, without disturbing the placement of a flexible guide wire which has previously been inserted through the first guide catheter. The device of the invention comprises an "exchange catheter" which may be advanced over the outer surface of the pre-positioned guide wire to provide support and shielding of the guide wire during the catheter exchange procedure. A guide wire exit aperture formed in the "exchange catheter" permits the guide wire to exit the exchange catheter at a location whereby the operator may hold and manipulate the guide wire to maintain its desired position during the catheter exchange procedure.

Abstract: A device and method for removing deposited material from subgingival tooth surfaces, under endoscopic guidance, without surgical cutting of the gingiva. In one embodiment, the invention comprises a simple endoscopic probe insertable into the gingival sulcus to endoscopically visualize the process of and/or effects of subgingival root planing, scaling or other plaque removal procedures carried out by other operative instruments. In another embodiment, the endoscopic viewing apparatus is incorporated into an operative instrument which is, in itself, usable to effect removal deposited material from subgingival tooth surfaces such that the operator may endoscopically view and/or guide the instrument while using the instrument itself to effect the removal of material deposited on the subgingival tooth surfaces. The invention includes methods for removing deposited material from subgingival tooth surfaces under endoscopic guidance and/or monitoring.

Abstract: Devices and a system for passing instruments into a body cavity and/or for containing, manipulating, treating and removing matter from the body cavity, through a minimal access incision typically no greater than 1 cm in length. In one embodiment, the device of the invention includes an upper valving member with a plurality of interchangeable lower trocar members such as a) a short trocar member of 0.5-0.3 inches in length, b) a long trocar member greater than 3.0 inches in length and/or c) a trocar member having a protective cage disposed about its distal end attachable thereto. The lower trocar members are insertable into the body cavity. Further, in accordance with the system of the present invention, various instruments are independently insertable through the upper valving member and lower trocar portions of the device to perform various functions.

Abstract: A method and system for adaptively controlled withdrawal/infusion of a fluid, such as blood, to or from a fluid source, such as a blood vessel. An adaptive flow rate limit is established and periodically adjusted during the course of withdrawal/infusion so as to maximize and optimize the withdrawal/infusion rate while, at the same time, providing for rapid corrective adjustments in flow rate responsive to early indications of flow disruption, such as occlusion or collapse of the blood vessel during blood withdrawal. The method and system of the invention is particularly applicable to automated apheresis systems.

Abstract: A membrane oxygenator having a gas pressure relief valve operable to release gas when the gas pressure in the oxygenator exceeds a predetermined level. Generally, the membrane oxygenator includes a housing in which is mounted a gas-permeable, liquid-impermeable membrane, i.e. a bundle of microporous hollow fibers. This membrane defines separate oxygen enrichable fluid and gas flow pathways. The housing also includes both gas and oxygen enrichable fluid inlet and outlet ports communicating with respective opposite ends of the gas and oxygen enrichable fluid flow pathways. The gas pressure relief valve communicates with the gas flow pathway.

Abstract: A simplified fluid separation method and device usable for various apheresis procedures, including plasmapheresis. At least one pump is utilized to draw a first fluid (e.g. whole blood) into a separation device. The separation device then operates to separate the fluid (e.g. whole blood) into first and second fluid fractions (e.g. a cell concentrate and blood plasma). The first and second fluid fractions are pumped from the separation device to separate first and second fluid fraction containers, both of which are positioned on a single weighing device, such as an electronic load cell. At least one of the fluid fractions is subsequently removed from its fluid fraction container and returned to the human subject or other fluid source. Weights recorded by the single weighing device are then utilized to calculate the actual weights of fluid and/or fluid fractions pumped by at least one pump during the procedure.

Abstract: Disclosed is a pneumatically-driven volume controlled bellows pump apparatus for oscillating liquid into a localized area of the human body, preferably methyl-tertiary butyl ether or another solvent, into the gallbladder. The pump includes a fluid reservoir in the form of an inverted syringe attached via a stopcock to the bellows. The bellows is attached via a second stopcock to a catheter also attached to a priming syringe. An inlet pinch valve is disposed between the bellows and the fluid reservoir and an outlet pinch valve between the bellows and the fluid receiver.To use the pump, a pigtail catheter with outlets in the pigtail is inserted into the desired area of the body, preferably a receptacle such as the gallbladder, to introduce a selected volume of liquid for gallstone dissolution. Liquid is infused into the receptacle by decompression of the bellows with the inlet but not the outlet valve open and then by compression of the bellows with the outlet but not the inlet valve open.

Abstract: A blood reservoir device comprising a generally flexible blood collection chamber having an inlet portion and a main portion. The inlet portion is preferably sized and configured such that blood entering the inlet portion will avoid turbulence and will undergo generally laminar flow through the inlet portion, into the main portion of the chamber. A vent tube is provided for venting coalesced or collected gas bubbles from the top edge of the chamber. Additionally, one or more filter elements may be positioned within the chamber to further facilitate removal of air bubbles from blood passing through the chamber.