Abstract: A medical device has an interior for containment of fluids; an opening into the interior, an elastomeric wall comprising a fixedly placed, flexible barrier across the opening; and a retention wall positioned adjacent to a peripheral portion of the elastomeric wall. The retention wall defines a central opening and has a generally rigid retention zone surrounding the central opening, to engage and retain a connector tube which is advanced into the central opening to open a flow aperture through the elastomeric wall, for flow through the wall and connector tube. One of the retention zone and connector tube may be made of a material of sufficient hardness that material of the other engaging member is deformed by engagement therewith, which increases the strength of retention between the retention wall and the connector tube.

Abstract: A tubular medical fluid flow set comprises a pressure sensing chamber connected in flow-through relation to fluid flow tubing of the set. The pressure sensing chamber defines a movable, flexible, impermeable diaphragm dividing the chamber into two separate compartments. The fluid flow tubing communicates with one of the compartments and is isolated from the other of the compartments. A port is carried on the chamber, the port having a seal therein, and communicating with the other of the compartments. Thus, the other of the compartments is hermetically sealed until the port is opened for connection with a pressure measuring device, to keep the flexible diaphragm in a desired, initial position prior to opening of the seal.

Abstract: A tubular medical fluid flow set comprises a pressure sensing chamber connected in flow-through relation to fluid flow tubing of the set. The pressure sensing chamber defines a movable, flexible, impermeable diaphragm dividing the chamber into two separate compartments. The fluid flow tubing communicates with one of the compartments and is isolated from the other of the compartments. A port is carried on the chamber, the port having a seal therein, and communicating with the other of the compartments. Thus, the other of the compartments is hermetically sealed until the port is opened for connection with a pressure measuring device, to keep the flexible diaphragm in a desired, initial position prior to opening of the seal.

Abstract: A pad of elastomeric material having a softness of no more than about durometer 30 Shore 00. The pad may carry adhesive for adhering the pad to a surface, either directly or indirectly through an envelope which surrounds the pad and carries the adhesive. Such a pad exhibits hemostatic and leak prevention properties against needle puncture holes in the skin or the wall of a hollow medical device. Particularly, hemostasis may be prevented with low pressure application of the pad to the skin. The pad may be previously applied to the skin of the patient or a wall of a medical device such as tubing or a solution bag, and the needle may then penetrate both the pad and the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.

Abstract: A pad of elastomeric material having a softness of no more than about durometer 30 Shore 00. The pad may carry adhesive for adhering the pad to a surface, either directly or indirectly through an envelope which surrounds the pad and carries the adhesive. Such a pad exhibits hemostatic and leak prevention properties against needle puncture holes in the skin or the wall of a hollow medical device. Particularly, hemostasis may be prevented with low pressure application of the pad to the skin. The pad may be previously applied to the skin of the patient or a wall of a medical device such as tubing or a solution bag, and the needle may then penetrate both the pad and the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.

Abstract: A medical tubing set sheath is provided which includes a retention portion for attaching the sheath to a collar of a connector attached to the medical tubing set. The sheath may serve as a handle to facilitate torque-locking of the connector to another connector. The sheath may also include a ratcheting mechanism in order to allow for the sheath to ratchet upon application of excess torque, when the tubing set is being attached to a peripheral tubing set. The sheath may also include a needle receiving portion, so that the sheath provides for a needle protector, which may be retained in a position displaced from the needle in order to insure that the needle is exposed when removed from its packaging, and can be quickly and easily inserted in a patient's arm.

Abstract: A pad of elastomeric material having a softness of no more than about durometer 50 Shore 00. The pad may carry adhesive and/or a housing for adhering the pad to a surface, either directly or indirectly through an envelope which surrounds the pad and carries the adhesive. Such a pad exhibits hemostatic and leak prevention properties against needle puncture holes in the skin or the wall of a hollow medical device. Particularly, hemostasis may be prevented with low pressure application of the pad to the skin. The pad may be previously applied to the skin of the patient or a wall of a medical device such as tubing or a solution bag, and the needle may then penetrate both the pad and the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.

Abstract: A winged needle comprises a hollow medical needle which typically is no smaller than 18 gauge carried by a hub. The hub has wings projecting laterally outwardly, the wings having outer tips that are spaced from each other by essentially 20 to 30 mm. A guard for a winged needle tube set is also disclosed, in which the guard comprises a needle guard tube free of wing-receiving slots and defining a forward, open end to receive a winged needle having outwardly extending, substantially unbent wings as positioned within the guard. In some embodiments, the guard comprises a substantially fixed, open mouth having a width of at least 20 mm and a height of at least 5 mm. A novel anchor strip having two flex lines is also provided to the guard.

Abstract: A medical device such as a female luer lock connector has an interior for containment of fluids. An access site on the medical device has an opening into the access site interior, which opening defines an annular, outer end surface surrounding the opening. An elastomeric wall is sealingly bonded to the annular, outer end surface at an inner face of the elastomeric wall. Typically, the elastomeric wall has a radially outwardly facing peripheral surface which is essentially spaced from the access site. Also, portions of the elastomeric wall, if desired, can project laterally outwardly beyond the annular, outer end surface, to frictionally engage a second medical device that is attached to the access site.

Abstract: A fluid flow connector comprises a connector body which carries a first connector tube having a lumen for receiving a second connector tube when the connectors are joined. The first connector tube has a lumen and a lumen wall. The first connector tube typically has an end portion that carries a plurality of circumferentially spaced, outerwardly extending lugs to engage the second connector tube when connected. The fluid flow connector is made of a plastic having a flexural modulus that is low enough to allow deformation, permitting a connected, engaging second connector to pop loose from connection with the fluid flow connector when laterally struck, rather than breaking the fluid flow connector.

Abstract: In general, this invention relates to methods and devices for introducing and/or draining fluids into and/or from a patient's body. Methods and devices are provided for rendering conventional tubing sets, or fluid flow sets, which are normally coupleable with only specific complementary patient access devices, compatible with other access devices also. In accordance with one aspect of the invention, methods and devices are provided which render conventional extracorporeal tubing sets to be interchangeably connectable with other specific transcutaneous catheters. In yet another aspect of the invention, non-conventional tubing sets and corresponding non-conventional access devices for use in hemodialysis, or hemofiltration, are provided such that specific tubing sets and access devices can be used interchangeably.

Abstract: A closure for a tubular access port in a medical fluid flow line or other container comprises a removable cap for enclosing and sealing the tubular access port. The cap has a closed end wall. The end wall carries an extending poker to facilitate the pushing of an antiseptic-carrying material into a lumen of the access port. The poker has an outer diameter that is less than the inner diameter of the access port. A method of using the poker is also described.

Abstract: A method for monitoring for leaks or disconnections in an extracorporeal blood circuit, comprising the steps of operating a blood pump to circulate blood through an extracorporeal blood circuit; opening a shunt connection between the arterial and venous blood flow portions; sensing the presence of air from any leaks or disconnections within the venous blood flow portion, and taking corrective action if the presence of air is noted. The shunt connection is typically periodically but only briefly opened, to check for leaks in the typically positive pressure portion of the venous set.

Abstract: A flexible valve for a blood treatment set. A flexible fitting including a first chamber, a second chamber, and a slit barrier connecting the first chamber and second chamber and positioned therebetween. An actuating member is positioned in rotating engagement with the slit barrier that is moveable from a first rotational position, in which the slit is closed, to a second position, in which the slit is open. The flexible valve is attachable to a port of a blood treatment chamber. A user opens the valve by rotating the actuating member from a first position to a second position and closes the valve by rotating the valve from the second position to a first position.

Abstract: A soft hemostasis pad of elastomeric material typically having a hardness of no more than about 50 Shore 00 and an upper wall having a raised profile, such as a convex shape. The pad has a central aperture extending therethrough, and a slit that extends through the pad thickness between the central aperture and the periphery of the pad.

Abstract: A medical tubing set sheath is provided which includes a retention portion for attaching the sheath to a collar of a connector attached to the medical tubing set. The sheath may serve as a handle to facilitate torque-locking of the connector to another connector. The sheath may also include a ratcheting mechanism in order to allow for the sheath to ratchet upon application of excess torque, when the tubing set is being attached to a peripheral tubing set. The sheath may also include a needle receiving portion, so that the sheath provides for a needle protector, which may be retained in a position displaced from the needle in order to insure that the needle is exposed when removed from its packaging, and can be quickly and easily inserted in a patient's arm.

Abstract: A soft hemostasis pad of elastomeric material having a hardness of no more than about 50 Shore 00 and an upper surface of raised profile, such as a dome. The pad may be connected by a hinge with another, generally flat-bottom pad of similar elastomeric material and hardness of no more than about 50 Shore 00. The pad may rest on the skin and be penetrated by a needle or other cannula. The pad with the raised profile may then be placed over on top of the needle, for improved hemostasis and sealing when the cannula is removed and before, facilitated by the application of gentle pressure, such as by tape that holds the pads in place.

Abstract: An extracorporeal blood set may be primed with physiological solution for use in a blood transporting process such as hemodialysis. The set comprises tubing having a patient connector on an end thereof, and a first branch tube in connection with a source of the solution. The branch tube connects with the set between the ends of the set. The branch tube also connects with further branch tubing, having a second connector which is capable of sealing connection with the patient connector. The method comprises the steps of connecting the patient connector and the second connector to form a closed loop of tubing. One then passes the solution from the source in flow through the first branch tube and further branch tubing to fill them and the set tubing with the solution. One then disconnects the patient connector for subsequent connection with the vascular system of a patient.

Abstract: A medical device has an interior for containment of fluids; an opening into the interior, and an elastomeric wall having at least one perforation. The wall comprises a fixedly placed, flexible barrier across the opening. The device also defines a passageway extending inwardly from adjacent to the elastomeric wall, the passageway being proportioned to receive and form an annular seal with a connector tube that extends into the interior through the perforation.

Abstract: A medical device has an interior for containment of fluids; an opening into the interior, an elastomeric wall comprising a fixedly placed, flexible barrier across the opening; and a retention wall positioned adjacent to a peripheral portion of the elastomeric wall. The retention wall defines a central opening and has a generally rigid retention zone surrounding the central opening, to engage and retain a connector tube which is advanced into the central opening to displace the elastomeric wall and to open a flow aperture through the elastomeric wall, for flow through the wall and connector tube. One of the retention zone and connector tube are made of a material of sufficient hardness that material of the other engaging member is deformed by engagement therewith, which increases the strength of retention between the retention wall and the connector tube.