Abstract: Patients having diminished circulation in the cerebral vasculature as a result of stroke or from other causes such as cardiac arrest, shock or head trauma, or aneurysm surgery or aortic surgery, are treated by flowing an oxygenated medium through an arterial access site into the cerebral vasculature and collecting the medium through an access site in the venous site of the cerebral vasculature. Usually, the cold oxygenated medium will comprise autologous blood, and the blood will be recirculated for a time sufficient to permit treatment of the underlying cause of diminished circulation. In addition to oxygenation, the recirculating blood will also be cooled to hypothermically treat and preserve brain tissue. Isolation and cooling of cerebral vasculature in patients undergoing aortic and other procedures is achieved by internally occluding at least the right common carotid artery above the aortic arch.

Abstract: In accordance with the invention, an intubation set is provided having an improved connector between the tube and a probe. In a preferred embodiment, the connector includes a deformable sleeve which at one end receives an end of the tube and at the other end is tapered to converge on the probe where it is permanently attached. The tube contains a solid insert which can be set in a compound such as silicone rubber and the sleeve is deformed radially inwardly to trap part of the tube containing the insert thereby locking the tube to the sleeve and hence to the probe. A method of making the intubation set is also provided. The invention also provides an improved intubation set for use in intubating the canaliculi without probing a healthy nasolacrimal duct.

Abstract: A method and apparatus for monitoring and measuring the filter blood volume by dilution techniques in real time, wherein the filter may be in use or off line during the measurements. The system includes a method and apparatus for measuring or monitoring the volume of a blood side of a filter by employing one of a bolus in the blood side upstream of the filter; a change of the filtration rate in the filter; and a bolus on the dialysate side, wherein the filter blood volume is calculated from the obtained data.

Abstract: Pulsatile blood flow in a heart-lung machine is accomplished by pumping blood into a bladder at a constant rate, and cyclically emptying the bladder into aortic line of the heart-lung machine either by means of the bladder's own elasticity or by a mechanical compression mechanism which can be programmed to simulate the human heartbeat.

Abstract: A vial access adapter for withdrawal of a medical fluid contained in a vial which includes a vial access adapter body having a circular top wall with a plurality of vent holes, a circular second wall spaced from the top wall, and a cylindrical side wall which walls define a chamber for holding an anti-bacterial filter. A first spike centrally located in the vial access adapter body extends through the top wall, chamber, and bottom wall, with one end extending above the top wall terminating in a threaded luer connector, while the other end terminates in a sharp point. A flow channel extends through the first spike designed for withdrawal of the medical fluid from the vial. A second spike positioned parallel to the first spike extends from the second wall, one end of which extends into the chamber, and the other end terminates in a sharp point. A flow channel extends through the second spike designed for air flow from the chamber into the vial.

Abstract: A needle assembly comprises an injection needle and a needle hub, mountable on a syringe, for securing the injection needle. The needle has an injection part extending axially from the hub and terminating in a skin piercing obliquely cut end. The length of the injection part is between 4 and 6 mm, thereby facilitating a proper subcutaneous injection. Also, preferably either (a) the outer diameter of the needle is smaller than 0.320 mm and the bore diameter is larger than 0.165 mm, or (b) the outer diameter is smaller than 0.298 mm and the bore diameter is larger than 0.133 mm. Also, preferably the hub includes an axially extending protrusion, from which the injection part extends, to facilitate insertion of the injection part into the skin of a user at an oblique angle.

Abstract: A system, including catheter apparatus, and related method for performing site specific therapy. The catheter apparatus can include one or more semipermeable microcatheters (preferably in the form of hollow fibers) for use in performing site specific microdialysis. The system and method are particularly suited for use in addressing cerebral edema by affecting the osmolar relationship between fluids making up the brain tissue. Also disclosed is an apparatus having a delivery/recovery mechanism in the form of a pump reservoir and one or more catheters in the form of semipermeable microcatheters, for use in delivering and/or recovering fluid to and/or from a tissue site or for performing tissue engineering outside of the body. The apparatus can be used in a method to perform site specific microtherapy, including for the treatment of compartment syndrome or cerebral edema.

Abstract: In an extracorporeal blood treatment system, non-treated blood may be withdrawn from a patient through an arterial line connected to a first compartment of a blood treatment apparatus. The blood treatment apparatus also includes a second compartment separated from the first component by a semi-permeable membrane. Treated blood may be returned to the patient through a venous line connected to the second compartment. In order to determine blood recirculation, i.e., a mixture of treated blood and non-treated blood in the arterial line, the ultrafiltration rate of plasma water through the semi permeable membrane of the treatment apparatus may be temporarily increased or decreased, and the resulting variation of the blood concentration, i.e., of the ratio of the volume of the plasma volume to the blood volume, is determined.

Abstract: A vacuum-assisted venous drainage reservoir for cardiopulmonary bypass surgery with both hard and soft shell reservoirs. The system utilizes a wall vacuum or other source of negative pressure to create a negative pressure via a regulator within a sealed hard shell reservoir, or within a sealed housing surrounding a soft shell reservoir. The addition of a negative pressure in the venous return line enables the use of smaller cannulas suitable for minimally invasive surgery. The reservoir need not be positioned well below the patient as in conventional gravity venous drainage configurations, thus adding flexibility to the operating room layout and enabling a reduction in the extracorporeal blood prime volume needed. In one embodiment, a flexible membrane in the hard shell reservoir expands to contact the blood surface and reduce blood/air interactions. In another embodiment, a moisture trap is provided between the source of vacuum and hard shell reservoir to reduce environmental contamination.

Abstract: An intravascular device comprising an intra-aortic and extra-aortic component for perfusing the spinal arteries during thoracoabdominal surgeries. The intra-aortic component comprises a catheter having a shunt releasably mounted on a distal end of the catheter. An expandable occluder is disposed about the shunt for occluding the aortic lumen. The extra-aortic component comprises a tubular member having a lumen communicating with a first end and a second end. The first end is adapted for attachment to the shunt. The second end of the second tubular member is attached to a plurality of tubular branches. A cooler may be attached to the second tubular member for providing hypothermic perfusion. When the intra-aortic component is attached to the extra-aortic component, blood flows from the proximal aorta to the spinal arteries through the lumens of the tubular branches. Methods of using the device for spinal perfusion during thoracoabdominal surgeries herein are also disclosed.

Abstract: A lancet device, a tip for a lancet device and method of using the lancet device. The lancet device has a body portion for firing the lancet and a tip portion. The tip for a lancet device includes a front assembly which includes a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element, a slot is disposed in one of the sidewall portion and the lancet stop element, and at least one following element extending into the slot, wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element. The method includes adjusting a set depth of penetration of the needle by moving the at least one following element, disposing the distal end of the lancet device against a surface of skin, and triggering the firing mechanism to cause the needle to penetrate the surface of the skin to the set depth, wherein the puncture allows a blood sample to be taken.

Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: A cardiac pacemaker programmed to pace in a demand mode with hysteresis is further programmed to recognize and correct a pacemaker mediated bradycardia. Such a pacemaker mediated bradycardia is the result of an idioventricular rhythm that occurs while hysteresis is operative and which inhibits the pacemaker from further pacing.

Abstract: Pressure is sensed in blood flow tubing by placing an aqueous, preferably isotonic, substantially cell-free solution into branch connection tubing that connects in branching relation with the blood flow tubing at one end. The branch connection tubing also connects in use with a pressure transducer unit at its other end. An air volume is maintained, occupying a portion of the branch connection tubing which is adjacent to the other end. One flows positively or negatively pressurized blood through the blood flow tubing, with the result that the pressure of the blood is communicated through the aqueous solution and the air volume in the branch connection tubing to the pressure transducer unit, with the blood being spaced from the air volume. Preferably, substantially all of the branch connection tubing containing the aqueous solution and air volume has an inner diameter of substantially no more than 5 mm.

Abstract: A dual-filled twin bag, a packaging including the twin bag, and a method for forming the packaged twin bags are provided. Each of two bags, a solution bag (10)and a drain bag (12) for a system used for a peritoneal dialysis procedure, are filled, at least partially, with a solution (14). A tubing set (16) connects the two filled bags (10,12) and may also be filled with solution (14) which is added to the bags (10,12) and the tubing set (16) during the manufacturing process. Alternatively, the tubing set (16) may be filled with air. The tubing set (16) is sandwiched between the solution bag (10) and the drain bag (12) and subsequently packaged in an overpouch (24). The method for forming the package including the bags filled with solution is simplified and the overall package size is reduced due to the sandwiched tubing set (16) between the solution bags (10,12) and the provision of solution in both bags (10,12).

Abstract: An exchanger and method for manufacturing the same are disclosed. In one embodiment, the exchanger crimps a hollow fiber bundle along a length of a cylindrical case in at least two radial positions. At least one crimp is between an inlet port and an outlet port of a blood conduit. Preferably, the cylindrical case has two portions with different radii so that when the two portions are mated to enclose the hollow fiber bundle, crimping is achieved. In this way, shunting of blood is avoided by being forced to pass a crimped position between the inlet and outlet ports to more evenly distribute the blood among the fibers of the bundle. In another embodiment, a method for making an exchanger includes filling a chamber, integral to the exchanger, with uncured potting material. The exchanger is spun to distribute the uncured potting material about open ends of an encasement. After curing, a portion of the potting material and the hollow fiber bundle are trimmed away.

Abstract: A circulatory support system and method for circulatory support are described for performing cardiopulmonary bypass using differential perfusion and/or isolated segmental perfusion of the circulatory system. The circulatory support system includes one or more venous cannulae for draining blood from the venous side of the patient's circulatory system, one or more arterial cannulae for perfusing the arterial side of the patient's circulatory system, and one or more blood circulation pumps connected between the venous cannulae and the arterial cannulae. The arterial cannulae and the venous cannulae of the circulatory support system may take one of several possible configurations. The circulatory support system is configured to segment a patient's circulatory system into one or more isolated circulatory loops.

Abstract: A medical instrument and method is provided for defoaming or preventing formation of foam in blood during extracorporeal blood circulation. The method comprises durably coating hydrophobic blood-contact surfaces with a nontoxic, biocompatible surface-active defoaming agent.

Abstract: Improvements to integrated blood pump/oxygenator having a rotating hollow fiber bundle assembly that both oxygenates and pumps blood are provided. An inner member arranged along a central axis of the device accelerates blood entering the fiber bundle to reduce microbubble generation and blood trauma. Shearing loads imposed on the fiber elements of the fiber bundle are reduced by the addition of a reinforcement structure, while the gas flow path is configured to reduce flooding and loss of oxygenation efficiency due to occasional rupture of fiber elements.