Abstract: An object of the invention is to provide a method for delivery of macromolecules into biological cells, such as Langerhans cells (22) in the epidermis (20) of a patient, which includes the steps of coating electodes (16) in an electrode assembly (12) with solid phase macromolecules to be delivered, such as a DNA, and/or RNA vaccine or a protein-based vaccine, attaching the electrode assembly (12) having the coated electrodes (16) to an electrode assembly holder (13), providing a waveform generator (15), establishing electrically conductive pathways between the electrodes (16), and the waveform generator (15), locating the electrodes (16) such that the biological cells are situated therebetween, such as by penetrating the needle electrode (16) into the epidermis (20) above the epidermal basal lamina, and providing pulse waveform from the waveform generator (15) to the electrodes (16), such that macromolecule on the electrodes (16) is driven off of the electrodes (16), and delivered into the biological cells, s

Abstract: An apparatus and method for blood oxygenation is provided, advantageously comprising an extracorporeal circuit for the preparation and delivery of hyperoxic or hyperbaric blood. In one embodiment, an apparatus for gas-supersaturating fluids, e.g., physiologic saline, includes a chamber having a first inlet to receive the fluid; a second inlet to receive a gas, e.g., oxygen, from a gas supply that maintains pressure within the chamber at a predetermined level, advantageously about 600 p.s.i.; and an outlet advantageously coupled to a capillary assembly. An atomizer nozzle coupled to the first inlet advantageously creates within the chamber fine droplets of fluid into which gas diffuses to create the gas-supersaturated fluid, which collects within the chamber below the atomizer nozzle for removal via the outlet.

Abstract: A compliant membrane is positioned between the interior of an expandable balloon and the inner member of a catheter. The membrane provides a compliant substrate onto which a stent is crimped onto the balloon over the area of the membrane. The compliant membrane effectively retains the stent on the catheter while the stent is being delivered through the vasculature. The retaining force from using a compliant membrane can be obtained by partially filling apertures as described. However, an enhanced retaining force is obtained without this effect. The membrane allows a higher normal force between the stent and balloon because of its compliance. A stent cannot be tightly crimped onto a rigid surface or tube because the elastic recoil of the stent prevents this. The compliant membrane has enough give to compensate for this small but significant elastic recoil. Essentially, the stent is squeezed onto the balloon/membrane slightly more than the final result to obtain a good gripping force.

Abstract: A method for forming an endovascular occlusion by controlling the injection parameters of a purified alginate liquid and a calcium chloride solution to meet and polymerize at a target site within the vascular system. Different types of injection techniques may be used with a preferred injection technique of simultaneous bi-directional injection where the purified alginate liquid is injected through a vein and the calcium chloride solution is injected through an artery.

Abstract: A drug delivery device comprising a housing (1) with a drug container (2) being provided with delivering means comprising a piston (5) for expelling a drug (4) from the drug container (2). The housing (1) further comprising a displaceable piston rod (6) abutting the piston (5) of the drug container (2) and rotating means being in engagement with the piston rod (6), said rotating means being provided with a one-way mechanism. The one-way mechanism comprises a helical spring (12) wound tightly around an axle (11), one end of said helical spring (12) being fixed in relation to the housing (1), the other end of the helical spring (12) being in a free state.

Abstract: A catheter with three spiral heat exchange elements surrounding a central supply tube and communicating with a source of heat exchange fluid in a closed loop for effecting patient temperature control and at least two infusion lumens for providing access to the central venous blood supply when the catheter is placed in the central venous system. An anchor can be provided to suture or tape the catheter to the skin of a patient.

Abstract: A therapeutic agent is delivered to heart tissue in a body. The therapeutic agent is introduced to a first side of the heart tissue. An electrode is percutaneously located on a second side of the heart tissue. The electrode is energized to induce migration of the therapeutic agent into the heart tissue.

Abstract: A needle safety device has a collar and a housing pivotally connected thereto. Cooperating locking members are provided at the collar and the respective lower sections of the housing so that, once the housing is pivoted to be in alignment with the collar, the locking members would coactingly mate with each other to thereby retain the housing to the collar. To ensure that the coacting locking members could not be sabotaged by the sidewalls of the housing being deliberately forced away from the collar, barriers in the form of guard flaps or arms are provided at the collar so as to prevent those sections of the sidewall that are susceptible to being forced away from the collar from being exposed. As an added benefit, the guard flaps could be used as an anchor to provide stabilization for the use of a hypodermic needle fitted with the safety needle device of the instant invention during a subcutaneous procedure to a patient.

Abstract: A hemodialysis and vascular access system which includes a catheter having an arteriovenous fistula utilizing an indwelling silastic venous end and an arterial end which is adapted to be anastomosed to an artery is described. The catheter includes a needle receiving s through which a needle is inserted to access fluid flow within the hemodialysis and vascular access system. The invention enables use of an “arterialized” indwelling venous catheter where blood flows from an artery through the hemodialysis and vascular access system and is returned to the venous system via an arrangement wherein the outflow opening is distinct and distant from the site where the catheter enters the vein. The site of blood return to the venous system is not directly fixed to the venous wall but is free floating within the venous system. This system provides a hemodialysis and venous access graft which has superior longevity and performance and is relatively easy to implant.

Abstract: A template for surgically implanting needles into a patient's body. A support backing of the template specifically angled and curved to conform to a body structure to provide stability in the relative positions between the body and the template. The template further having a locking mechanism to hold needles in place after they have been inserted into the body structure, the locking mechanism utilizing a channel to guide a floating plate in vertical motion with respect to a contiguous stationary plate. When force is applied to the floating plate, the relative motion of the plates puts a locking force on the needles which run through holes in the two contiguous plates. A hollow protective covering to be mounted over the front face of the template to protect the ends of the needles that have been inserted through the template and into the patient.

Abstract: Apparatus and methods for perfusing ischemic myocardium are provided using a tubular member having an end region adapted to be disposed in a portion of a patient's venous vasculature. The end region includes a lumen and a valve in communication with the lumen that controls pressure within an occluded portion of the vasculature by venting excess blood at a location proximal of a point of occlusion of the vasculature via the valve. An occlusion element optionally may be provided in the end region that retains the tubular member within the patient's venous vasculature and occludes the flow of blow around the lumen.

Abstract: An orientationally adjustable marking syringe provides automatic loading of medicine from a medicine source to the syringe. Actuation of the handles of the syringe simultaneously discharges or injects the contents of the syringe and a marking substance such as ink contained in an ink dispenser integrally attached to the marking syringe by a pivoting ink carriage. The pivoting ink carriage can be pivoted about the syringe to better accommodate the ergonomic desires of the user and the objectives of the injection.

Abstract: A catheter with metal heat exchange elements communicating with a source of coolant in a closed loop for effecting patient temperature control and at least two infusion lumens for providing access to the central venous blood supply when the catheter is placed in the central venous system. An anchor can be provided to suture or tape the catheter to the skin of a patient.

Abstract: A medical catheter comprising a proximal end having an opening for fluid containing a therapeutic drug, a distal end, the distal end defining at least one opening, and a porous portion covering the opening defined by the distal end. In one embodiment, the medical catheter comprises a proximal end having an opening for fluid containing a therapeutic drug, at least two distal ends. the proximal end connected to the two distal ends with a connector, the distal ends each defining at least, one opening, a diffuser covering the opening of each distal end, and a separate restrictor downstream of the connector and upstream of each distal end to provide substantially equal flow through each distal end. An additional restrictor can also be placed upstream of the connector. In another embodiment, a combination diffuser and restrictor covers the opening of each distal end.

Abstract: A needle protection device for a vial has a collar at the base of which a number of finger grippers extend. The collar is placed about the hub of a vial and pushed therealong until the gripper fingers snap over the bottom surface of the needle hub so as to fixedly couple the collar to the needle hub of the vial. Flexibly extending from the collar is a housing that is pivotable to a position in alignment along the longitudinal axis of the vial for enveloping the needle, to thereby prevent the needle from being exposed to the environment. A hook integrated to the inside of the housing ensures that the needle and the housing could no longer move relative to each other once the hook snaps over and traps the needle, as the housing is pivoted to its alignment position. For those vials that have a needle hub that extends smoothly from the vial, a second embodiment of the instant invention has, in place of the collar, a base that has two extending arms with coacting ends.

Abstract: A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

Abstract: The present invention provides a microfistula tube including a soluble duct, defining a drainage canal having an inner surface, the duct being biocompatible, wherein the microfistula tube is coated with and/or incorporates biological for forming a basement membrane, or an intracellular matrix and a basement membrane. The biological cells may coat the inner surface of the drainage canal, and the microfistula tube may be made of a mouldable material or an absorbable material. The invention also provides an implantation system for the microfistula tube including a microfistula tube and a surgical instrument including an outer tube for penetrating body tissue, an inner tube, and an innermost rod, wherein the outer tube, the inner tube and the innermost rod are coaxial, the outer tube is adapted to receive said microfistula tube, whereby the inner tube may be used to push the microfistula tube into position and the innermost rod provides mechanical support during implantation of the microfistula tube.

Abstract: An external medical drainage system is provided which has a slide interface between a mounting assembly to a pole, and a disposable drip assembly and a stopcock which snap-fits to the mounting assembly. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, tubing extending from the graduated cylinder opposite the drainage bag, and a stopcock associated with the tubing and fixed to a clip. The stopcock clip snap-fits into clip-accepting notches of the clamp. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: A process for treating a patient with hydrocephalus is disclosed which utilizes an external medical drainage system having a slide interface between a mounting assembly and a disposable drip assembly. The mounting assembly is generally reusable and the drip assembly disposable. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, and tubing extending from the graduated cylinder opposite the drainage bag. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: The present invention is a passively shieldable blood collection set. The blood collection set includes a needle cannula, a hub mounted to the needle cannula and a tip guard slidably movable along the needle cannula. The tip guard can be slid into a distal position where the tip of the needle cannula is safely shielded. A collapsible guard drive is mounted to the hub and includes a pair of collapsible leaves extending from the hub to the tip guard. The leaves have a length that enable the tip guard to move into shielding engagement around the tip of the needle cannula, while preventing complete removal of the tip guard from the needle cannula. The leaves are resiliently deformable and can be collapsed onto themselves and onto the hub. The leaves can be retained in their collapsed condition by a packaging cover and subsequently by the grip of a medical practitioner.