Abstract: A compact fluid dispenser for use in controllably dispensing fluid medicaments and a cooperating reservoir fill assembly for controllably filling the fluid reservoir of the fluid dispenser. The fluid dispenser component includes a novel stored energy source in the form of an expandable, elastomeric member of unique construction that provides the force necessary to continuously and substantially uniformly expel fluid from the reservoir of the dispenser component. The fluid dispenser component further includes a fluid flow control assembly that filters and precisely controls the flow of the medicament solution from the reservoir of the dispenser container.

Abstract: The invention relates to an apparatus and method for limiting the pressure of inflation fluid injected into a drug delivery catheter balloon, while permitting continuous and uninterrupted flow of such fluid to the balloon. The apparatus includes an elongated hollow housing having a fluid entrance, a fluid exit and a bore extending therebetween which forms an interconnecting chamber and passageway. A piston and piston shaft assembly is disposed inside the housing and is longitudinally movable within the chamber. The piston and piston shaft assembly is biased against the fluid pressure of the fluid entering the housing by a spring. The piston shaft has a distal end which extends toward the passageway inlet. As the incoming fluid pressure increases and approaches the predetermined maximum pressure level of the apparatus, the piston shaft distal end moves within the chamber against the biasing force of the spring toward a position adjacent the passageway inlet.

Abstract: A safety syringe includes a barrel having a front neck, a needle holder mounted in the front neck of the barrel to hold a needle unit outside the front neck of the barrel, the needle holder having a rear coupling hole, a plunger reciprocated in the barrel, and a coupling member connected to the plunger, the coupling member having a conical split head, which is forced into engagement with the rear coupling hole of the needle holder for enabling the needle holder and the needle unit to be carried backwards with the plunger and received inside the barrel after the use of the syringe.

Abstract: A cassette which is adapted to be insertable into and removable from an infusion pump. The cassette has a housing, a length of flexible tubing supported by the housing, and a first vertically movable member disposed in the housing. The first vertically movable member has a slot formed therein, and a portion of the flexible tubing is disposed within the slot. The first vertically movable member is movable between a clamped position in which the flexible tubing is clamped to prevent any substantial liquid flow therethrough and an unclamped position in which substantial liquid flow through the flexible tubing is enabled, and a spring is provided for biasing the first vertically movable member to the clamped position. The first vertically movable member may be designed so that the closure of a door of an infusion pump in which the cassette is inserted will cause the vertically movable member to be in the unclamped position to allow liquid flow through the flexible tubing.

Abstract: An endoscopic portal for establishing communication with a body cavity for the introduction of instruments through the endoscopic portal includes a seal having a variable size passage for communication with the body cavity to permit instruments of varying sizes to be passed therethrough and a tubular expander aligned with the variable size passage. The seal is biased to a contracted position wherein the variable size passage has a first cross sectional size and is movable to an expanded position wherein the variable size passage has a second cross sectional size larger than the first cross sectional size. The tubular expander has a blunt end insertable in the variable size passage to move the seal from the contracted position to the expanded position such that an instrument having a cross sectional size larger than the first cross sectional size can be introduced through the expander and the seal into the body cavity without contacting the seal.

Abstract: The invention provides systems and methods for infusing a fluid into a patient. In one exemplary embodiment, a system comprises a volume of fluid and a temperature altering device in close proximity to the volume of fluid. The temperature altering device is employed to heat or cool the volume of fluid to a desired temperature. A positive pressure device is provided to place the volume of fluid under positive pressure while at the desired temperature. A transfer member is further provided to transfer at least some of the fluid into the patient while at the desired temperature.

Abstract: A long-term dialysis catheter system for use in a body of a patient includes a guide catheter having a guide lumen defined therein, wherein the guide lumen defines a distal guide orifice. The system also includes a tissue ingrowth member secured to an outer surface of the guide catheter. The system further includes an original dialysis catheter positionable between an original inserted position and an original removed position, wherein (i) the original dialysis catheter has an original ingress lumen and an original egress lumen defined therein, (ii) the original ingress lumen defines an original distal ingress orifice, and (iii) the original egress lumen defines an original distal egress orifice.

Abstract: A perfusion dilatation catheter is disclosed which has an improved distal catheter shaft portion with a tubular member extending within the balloon provided with an expanded coil support incorporated within the wall of the tubular member. The coil is preferably closer to the inner surface than the outer surface of the tubular member. Also disclosed are improved catheter shaft sections in a perfusion portion proximal to the balloon, one with a reinforced inflation tube depending into the guidewire lumen and another having three separate lumens, a central guidewire lumen and a pair of inflation lumens on opposing sides of the tubular structure defining the guidewire lumen.

Abstract: An endoscopic portal for establishing communication with a body cavity for the introduction of instruments through the endoscopic portal includes a seal having a variable size passage for communication with the body cavity to permit instruments of varying sizes to be passed therethrough and a tubular expander aligned with the variable size passage. The seal is biased to a contracted position wherein the variable size passage has a first cross sectional size and is movable to an expanded position wherein the variable size passage has a second cross sectional size larger than the first cross sectional size. The tubular expander has a blunt end insertable in the variable size passage to move the seal from the contracted position to the expanded position such that an instrument having a cross sectional size larger than the first cross sectional size can be introduced through the expander and the seal into the body cavity without contacting the seal.

Abstract: An adaptor system includes a plastic syringe which is pre-filled with a liquid medicament, and a plastic flange adaptor which can be attached to the syringe. The medicament-prefilled syringe is provided with a cylindrical body having a small diameter cylindrical body to which a liquid medicament information label is adhered and a large diameter cylindrical body, and an end flange. The flange adaptor is provided with a cylindrical base portion having an insertion hole whose diameter is such that the inner wall of the insertion hole does not contact the small diameter cylindrical body of the syringe and is in contact with the large diameter cylindrical body when the flange adaptor is fitted to the syringe, and a large diameter flange portion which surrounds the end flange of the syringe. The invention is also directed to a medicament-prefilled plastic syringe itself.

Abstract: A combination syringe and needle are disclosed wherein the needle assembly is mounted to a retractable element which retracts into the body of the syringe plunger. The needle assembly is mounted to the needle retractor which is spring biased to retract the needle. The retraction is actuated by releasing the forward end of the retractors from engagement with a collet positioned within the forward end of the syringe outer barrel. The collet is configured so as to clamp the forward end of the retractor and only releases the forward end when the collet is pushed forward, expanded, and disengages the forward end of the needle retractor. The pressure required to fully expand the collet causes the cap located on the forward end of the hollow plunger to collapse after being penetrated by puncture tabs formed on the collet base. The hollow plunger serves as a receptive container for the needle and hub forced into the syringe by spring biased upon release of the holder by the collet as it expands.

Abstract: An insulin injection system comprises a pen shaped syringe with a cartridge containing insulin, and an injection needle. The needle is a G30 needle and the insulin is a type which may freely flow through a G 30 needle. When the insulin is the type comprising suspended crystals the maximal dimension of any crystal is 15 .mu.m.

Abstract: A blood containment device for use with a vascular entry needle provides visual and tactile confirmation that a blood vessel has been properly entered. The device includes a blood visualization chamber defined by a compliant member which provides a visual indication that a needle connected to the device has accessed a selected blood vessel. The blood visualization chamber is vented to allow air to escape therefrom as it is displaced by blood entering the visualization chamber, while a gas permeable membrane in communication with the vent to prevent significant blood from escaping from the blood containment device. A sealing member formed on an outer surface at one end of the compliant member works in conjunction with the gas permeable membrane to prevent significant leakage of blood from the device. The compliant member pulsates with changes in blood pressure, thereby providing continuous tactile confirmation that the needle tip is properly positioned within the selected blood vessel.

Abstract: An intravascular balloon catheter including a dilation balloon is provided. The intravascular balloon catheter includes a shaft assembly including a proximal end, a distal end, and an inflation lumen extending longitudinally therethrough. The dilation balloon is operably coupled proximate the distal end of the shaft assembly, such that an interior chamber of the dilation balloon is in fluid communication with the inflation lumen. In one aspect of the invention, a core wire is disposed within the inflation lumen of the shaft assembly. In another aspect of the invention, a tubular member extends longitudinally over the exterior of the dilation balloon for receiving a guidewire.

Abstract: An elastomeric bladder type infusion device for delivering a beneficial agent, such as a drug to a patient at substantially a constant rate. The device uniquely includes an adjustable flow rate control mechanism for adjusting the rate at which fluid flows from the device. In one form of the invention, the apparatus also includes a novel flow indicator for visually indicating fluid flow from the device.

Abstract: A blood containment, visualization and tactile confirmation device is provided for use with a vascular entry needle. The device includes a visualization channel and/or a compliant outer wall portion which indicates whether a needle connected to the device has entered a selected blood vessel. The visualization channel is optionally vented to the outside to allow displaced air to escape, but has a gas permeable member to prevent blood from escaping. Alternatively, the visualization channel is substantially sealed such that it is not significantly vented. Preferably, a compliant outer wall portion defining the visualization channel pulses with changes in blood pressure, thereby providing a tactile indication that the needle tip is properly positioned. The device has a guideway with a barrier of elastomeric material which prevents blood from passing therethrough, but which allows passage of an elongated medical instrument such as catheterization apparatus.

Abstract: Parts which may be integrally molded with a phlebotomy barrel or with a Luer fitting to provide, in a single molded part, an extendable safety enclosure for a medical cannula in phlebotomy, syringe and other general medical needle applications. Integrally molded part phlebotomy safety devices are disclosed which require only the integrally-molded part, a medical needle, a label and a transport needle cover to form a ready-to-use phlebotomy device. Upon removal of the label and needle cover, the device is ready for use in a medical procedure. The enclosure comprises a plurality of rigid segments serially connected by a plurality of intersegment hinges, which are preferably living hinges. The segments are disposed about a medical needle, folded upon each other during the medical procedure and extended at the end of the procedure to form a secure, substantially rigid safety shroud. During the procedure, the enclosure is folded and conveniently disposed about a proximal portion of the needle.

Abstract: An improved method and apparatus for treating herniated discs involving the preliminary intra annular ultrasonic softening of the herniated disc portions to be removed with a discectomy instrument that suctions and cuts the softened portions of the herniated disc. An ultrasonic probe is inserted into the central region of the disc to soften the desired region. A discectomy instrument is subsequently inserted into the softened portion of the disc and tissue is removed by suctioning the softened tissue portion into the tip of the instrument needle and severing the suctioned portion of the disc within the tip of the needle. The cut material is then aspirated.

Abstract: The balloon catheter comprises a catheter tube surrounded distally by an elongated inflatable balloon. Throughout the catheter tube is a longitudinal lumen for positioning a radioactive radiation emitter within the balloon. The catheter comprises a second lumen for directing inflation fluid into the balloon. Belt means creating a waist are mounted on the balloon to squeeze it down to nearly the diameter of the catheter thereby leaving a small passage for the inflation fluid. The belt means divide the balloon into sections to assure a close center fit of the catheter within the balloon.

Abstract: An assembly (20) of syringes (22) includes a first layer (32) enclosing the syringes. The first layer maintains the syringes in an orientation where some of the syringes have a first, larger end aligned with the second, smaller end of the remainder of the syringes. The first layer also protects the syringes from outside contaminants. A second layer (34) encloses the first layer and protects it from outside contaminants. The syringes and the first layer preferably are sterilized within the second layer 34.