Abstract: A surgical seal assembly for use with a surgical access device includes a seal housing defining a central longitudinal axis and having a longitudinal passage dimensioned to permit passage of a surgical instrument through the seal housing, a gimbal mount disposed within the seal housing and having a gimbal seal member defining an aperture for substantial sealed reception of the surgical instrument, and an interface seal disposed within the seal housing. The gimbal mount is adapted for angular movement relative to the central longitudinal axis upon angulation of the surgical instrument whereby the gimbal seal member substantially maintains the sealed reception of the surgical instrument. The interface seal includes an interface seal member extending at least along the longitudinal axis and being in substantial contacting sealing relation with the gimbal mount. The interface seal member is adapted to maintain the sealing relation with the gimbal mount upon angular movement thereof.

Abstract: An optical pressure monitoring system includes a tube from an infusion set and an optical signal sensor disposed to detect changes in the diameter of the tube and thereby determine pressure changes within the tube. By selecting the position of the tube relative to the optical signal emitter and optical signal receiver, the optical signal sensor can both detect pressure changes and provide an integrity check for both the functioning of the optical signal sensor and the placement of the tube. By modifying the tube to exaggerate changes in tube diameter responsive to pressure changes, the sensitivity of the optical signal sensor can be increased.

Abstract: Methods and devices are provided for administering a drug to a patient's eye. The methods include (a) inserting a hollow microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma; and (b) infusing a fluid drug formulation through the microneedle and into the sclera or cornea. It further may include partially retracting the microneedle before infusion to enhance delivery. Alternatively, the methods may include (a) inserting a solid microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma, wherein the solid microneedle comprises a first quantity of a drug formulation and inserting causes the solid microneedle to form a pocket in the sclera or corneal stroma; and (b) releasing the drug formulation into the pocket to form a drug depot, whereby a drug is released from the depot. The methods and devices may include an array of multiple microneedles.

Abstract: An infusion pump includes: a housing, a pump actuator supported by the housing, electronics configured to control the pump actuator, a pain controlled analgesic (“PCA”) input device, a cord having a remote end connected to the PCA input device and a local end connected to the housing, a remote integrated circuit; and a local integrated circuit in communication with the electronics and the remote integrated circuit so as to provide operational information concerning the PCA input device to the electronics.

Abstract: An apparatus for removing a pigmented section of skin, comprises a) a skin puncturing device; b) an array of one or more needles connected to said device for puncturing the skin at said pigmented section; and c) a mediating member attached to said device and to suction means, for allowing said suction means to collect the mixture of the pigments with the cellular fluids at said punctured section of the skin.

Abstract: The intravascular catheter has two segments; a proximal segment with high stiffness and a distal segment with lower stiffness. The catheter can also have an intermediate segment of lower stiffness than the proximal segment and higher stiffness than the distal segment. The catheter comprises a polymeric inner tube, a reinforcing inner jacket which is spirally wound over the inner tube and which becomes progressively softer from a proximal end to a distal end, and a polymeric outer sheath extruded over the inner jacket according to the teachings of U.S. Pat. No. 5,445,624. The reinforcing jacket comprises helical coiled wires or fibers of various materials and layers wound over the inner tube in order to provide improved multi-axial mechanical properties, such as torque, compression, tension and anti-kinking characteristics.

Abstract: To provide an access route which is leaktight and at the same time permits mobility and exact positioning of an instillation catheter (6), an arrangement comprising an instillation catheter (6) and a connector piece (1) for attachment to a tracheal or endotracheal tube is proposed. The connector piece (1) has a distal end (1a) for attachment to the tube, and a proximal end (1b) for attachment to a ventilation and/or suction device and comprises a branch (5) which serves for insertion of the catheter (6) and in which a valve (2) is arranged. The valve (2) is made, at least in some areas, from an elastically deformable material and can be opened by insertion of the catheter (6). The valve further comprises a proximal through-opening (21) whose inner wall has a means allowing sealing against axial flow of fluid between catheter (6) and inner wall, and, in the distal direction from the through-opening, it has a beak section (22) which, at its beak tip (23), has a normally closed slit (24).

Abstract: A pressure compensating IV rate flow regulator having a housing with a metering port and an outlet. The flow rate is set by adjusting a flexible disk to vary the clearance between metering port and flow passageway. The controlled fluid passes to a land surrounding the outlet. A flexible control membrane having specific design and material characteristics extends across the land and will move or oscillate away or towards the outlet port in response to changes in head pressure, venous back pressure or patient movement. The resulting oscillation of the membrane serves to maintain the flow rate originally set by the clinician. The regulator is provided with safety and operational convenience features such as tactile indicators for “off” and KVO settings and has provision for use with accessory items such as a pole mount holder or anchoring device secured at the forearm or chest.

Abstract: A distal end of a flexible catheter can be selectively deflected in a desired direction by actuating one or more actuators that extend outwardly of an exterior surface of the catheter. Each actuator can be a balloon disposed within a non-extendible balloon or sheath. Inflation of one (or both) of the balloon and the non-extendible balloon with a pressurized fluid can deflect the distal tip of the catheter. Another actuator embodiment comprises a strip of a bimorph material that bends outwardly when actuated, e.g., by heat, applying a force against adjacent tissue to deflect the distal tip. Yet another embodiment includes a strip of material that shortens when heated and can be coupled to a balloon that is inflated outwardly to increase a radial moment arm of the force applied thereby, relative to a neutral axis of the catheter, to more readily deflect the distal tip.

Abstract: An improved apparatus and method to catheterize passages is disclosed. The present invention provides a catheter having a soft flexible pre-formed distal tip, that when used in combination with commercially available guidewires of variable stiffness, results in the ability to control the direction and angle of wire advancement allowing cannulation of body passages, including those that arise at acute angles. The catheter can have a longitudinal axis, a proximal section and a distal section having a soft flexible pre-formed tip having a curvature of ninety degrees or greater and shape retention. The catheter can have an inner wall that defines a lumen that runs along said longitudinal axis forming a single continuous tube, a reinforcement braid disposed over the inner wall, and an outside covering disposed over the reinforcement braid. A spacer can be added between said wall liner and said reinforcement braid in the proximal end.

Abstract: A system for testing a negative pressure wound dressing, includes a simulated wound having a housing and a wound cavity within the housing, and having a shape and dimension representative of an actual wound type, a wound dressing positionable at least over the simulated wound, a negative pressure source in fluid communication with the wound cavity, at least one sensor adapted to record at least one parameter within the simulated wound, an air leak model including a valve in fluid communication with the wound cavity whereby opening of the valve simulates an air leak within the wound cavity, a fluid source in fluid communication with the wound cavity for delivering fluid to the wound cavity to simulate presence of exudates and a computer coupled to the at least one sensor for recording and analyzing data recorded by the at least one sensor to thereby providing an indication of functioning of the system.

Abstract: A cassette insertable into an irrigation or aspiration machine for endoscopy includes an irrigation or an aspiration tube and a support provided with one or two inlet plugs and one or two outlet plugs where two tubes form an elbow to be connectable to the inlet or outlet plugs in an input and output direction of motion, respectively and to form an irrigation or aspiration pumping area in the input and output direction of motion. The support includes a T-shaped guide according to the head of the T for protecting the elbow of each tube and according to the length of the T body in a slot guiding the tube in the output direction. The T-shaped guide extends between one or two inlet plugs to form the irrigation or aspiration pumping area on both sides of the slot between each inlet plug and the head of the T.

Abstract: The present invention provides apparatus and methods for facilitating folding of a balloon before, during or after a medical procedure. In a first embodiment, the apparatus generally comprises at least one catheter shaft member, a balloon disposed on a distal region of the catheter shaft member, and at least one folding member disposed along at least a proximal region of the balloon. The folding member may comprise at least one radially-outward projecting member integrally formed with or attached to the balloon, or an internally-formed groove in the balloon, which is adapted to promote twisting of the balloon to reduce the profile of the balloon in the deflated state. Optionally, biasing members may be disposed between the folding member and an adjacent portion of the balloon to promote folding of the balloon in a clockwise or counter-clockwise direction.

Abstract: According to one aspect of the invention, a fluid carrying connector comprising a luer lock connector is provided. At least one projection is defined on, or extending from, a surface of the luer lock connector. A shroud is moveably positioned with respect to the luer lock connector. The shroud comprises at least one projection that is rotatably positionable with the projection of the luer lock connector. In one rotational direction of the shroud, the projection of the shroud rotates the projection of the luer lock connector in the rotational direction. In an opposite rotational direction of the shroud, the projection of the shroud does not rotate the projection of the luer lock connector in the opposite rotational direction.

Abstract: A microneedle insertable in a target cell tissue, including a manipulative end maintained exterior of cell tissue and an insertion end positionable in or adjacent of target cell tissue. A plurality of microtubes are bundled to pass through the needle body and extend to respective distal ends grouped proximally interior of the insertion end. A sensing fiber is extendable from means for sensing for passage through the needle body to a distal end capable of sensing cell tissue parameters. The insertion end and the bundled microtube and sensing fiber distal ends are positionable in or adjacent of cell tissue thereby providing rapid evaluation of cell parameters by optic fiber sensing, fiber sampling of cell parameters, and precise delivery of therapeutic fluids or additional treatment measures. A method is also disclosed of precisely positioning a microneedle having a plurality of microtubes and sensing fibers therein for evaluating and treating cell tissue.

Abstract: High radiopacity is achieved in a polymeric marker by combining a polymeric resin, a powdered radiopaque agent having uniformly shaped particles of a specific particle size distribution and a wetting agent. The method to produce the marker calls for the blending and pelletization of these materials followed by extrusion onto support beading. The resulting supported tubing is subsequently cut to length with the beading still in place. After ejection of the beading remnant the marker is slipped into place on the device to be marked and attached by melt bonding. Marking of a guidewire allows lesions to be measured while the marking of balloon catheters allow the balloon to be properly positioned relative to a lesion.

Abstract: An augmented, adaptive algorithm utilizing model predictive control (MPC) is developed for closed-loop glucose control in type 1 diabetes. A linear empirical input-output subject model is used with an MPC algorithm to regulate blood glucose online, where the subject model is recursively adapted, and the control signal for delivery of insulin and a counter-regulatory agent such as glucagon is based solely on online glucose concentration measurements. The MPC signal is synthesized by optimizing an augmented objective function that minimizes local insulin accumulation in the subcutaneous depot and control signal aggressiveness, while simultaneously regulating glucose concentration to a preset reference set point. The mathematical formulation governing the subcutaneous accumulation of administered insulin is derived based on nominal temporal values pertaining to the pharmacokinetics (timecourse of activity) of insulin in human, in terms of its absorption rate, peak absorption time, and overall time of action.

Abstract: A transdermal electrotransport drug delivery device having an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode. At least one of the anode and the cathode includes an electrode and a reservoir comprised of a housing composed of a polymeric material and an aqueous medium in contact with the housing. The aqueous medium includes (i) a drug or an electrolyte salt or a mixture thereof, (ii) propylene glycol, and (iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium. The propylene glycol prevents the antimicrobial agent from being adsorbed by other materials used in the construction of the delivery device. A process for preparing a transdermal electrotransport drug delivery device is also provided.

Abstract: An injection aid for a syringe includes a disk with a central orifice and a flange. The flange is located on the top of the disk, and surrounds the central orifice. The outlet end or needle hub of a syringe or insulin pen fits in the flange, with the syringe needle extending through the orifice, thereby securing the disk to the syringe. The bottom surface of the disk is generally flat. The bottom surface of the disk makes contact with the skin when the needle is inserted to the proper depth. In other words, the needle lies perpendicular to the disk and is arranged to project past the disk's flat bottom surface by a set, pre-determined length. When the disk is pressed flat against a patient's skin, the needle is at the proper depth for the substance being injected.

Abstract: Tube, in particular for the use in medical devices in the form of catheters for endoluminal operations, wherein in at least one portion of its wall there are obtained notches (either slits or grooves) such as to locally increase the flexibility of the tube. The notches are provided in at least one distal zone of said tube.