Abstract: This invention is a surgical device. In particular, it is a catheter suitable for accessing a tissue target within the body, typically a target which is accessible through the vascular system. Central to the invention is the use of a stiffener ribbon, typically metallic, wound within the catheter body in such a way as to create a catheter having a controllable stiffness. The stiffener ribbon is adhesively bonded to a flexible outer tubing member so to produce a thin wall catheter section which is exceptionally flexible but highly kink resistant. The catheter sections made according to this invention may be used in conjunction with other catheter sections either using the concepts shown herein or made in other ways. Because of the effective strength and ability to retain a generally kink-free form, these catheters may be effectively used in sizes which are quite fine, e.g., 0.015" to 0.020" in diameter, and useable within typical vascular catheters.

Abstract: An injector is provided for automatic placement of a subcutaneous infusion set or the like used for delivering a selected medication to a patient. The injector comprises a spring-loaded plunger having a head for receiving and supporting an infusion set in a position for placement of an insertion needle and related cannula through the skin of a patient at a selected insertion site. The plunger head includes a safety lock mechanism for engaging and retaining the infusion set during spring-loaded advancement with a controlled force and speed toward the patient's skin to transcutaneously place the insertion needle and cannula. When the plunger head reaches a fully advanced position, with the infusion set placed on the patient, the infusion set is releasible from the safety lock mechanism with minimal force to permit quick and easy separation of the injector.

Abstract: Drip chamber heads are disclosed for attachment to drip chambers in which the drip chamber head includes a vertical body, a first connector for connecting the body to a blood supply, and a drip tube disposed within the body including a depending lower portion, the upper portion of the drip tube being in communication with the first connector so that blood may be supplied to the drip chamber through the first connector and the drip tube, thereby providing the blood at an adjustable level within the drip chamber with an air filled region thereabove, a second connector disposed at the upper portion of the body for communicating with the air filled region of the drip chamber, and an air permeable filter disposed at the upper portion of the body between the second connector and the adjustable level of blood within the drip chamber whereby the air pressure within the air filter region of the drip chamber can be sensed through the second connector.

Abstract: A device for introducing an active substance solution into a patient and with means for fastening to the skin and a cannula. The cannula is held in a withdrawn position by a retaining and releasing mechanism before use and, after release, is propelled into the patient's skin. A connector connected to the rear of the cannula serves to connect the cannula to an active substance reservoir.

Abstract: A gene transfer delivery apparatus and method includes a plurality of syringes retained in a syringe-retaining portion. Each syringe contains a predetermined quantity of treatment solution. The treatment solution may be expelled through a needle on the end of each syringe by depressing the syringe plunger associated with each syringe. The syringe-retaining portion of the delivery device is connected to a plunger portion which contains a main plunger capable of depressing the syringe plungers simultaneously. Since the syringe plungers are depressed uniformly, the delivery device allows for the precise injection of a fixed volume of fluid at plural locations and at a predetermined depth. A spring-biased platen is mounted on the device for flattening the tissue prior insertion of the needles into the tissue. A method of using the delivery device for treatment of ischemic heart disease by gene therapy is also disclosed.

Abstract: A catheter introducing system includes an introducer catheter comprising a flexible sheath having a hemostasis valve and an obturator having a steering mechanism operated by a proximal actuator handle. The catheter introducer system will usually be introduced with the obturator inside of the flexible sheath so that the obturator can effect steering by laterally deflecting the distal end of the combined sheath and obturator. Such catheter introducing systems are particularly useful for large diameter sheaths which are not readily introduced over guide wires. A first exemplary hemostasis valve comprises a compressed foam insert having an axial lumen therein. A second exemplary hemostasis valve comprises an elastomeric insert which receives and seals over the catheter.

Abstract: A catheter having various flexibility properties along the longitudinal extent thereof comprises contiguous tubular segments formed from polymeric materials having various physical properties. To manufacture the catheter, a grounded wire is conveyed through adjacent coating chambers separated by movable walls, each chamber containing an aerated powder of charged polymer particles having a flexibility property. The charged polymer particles are simultaneously deposited on the grounded wire, and then heated and cooled to form a polymeric tube. Each chamber has its own dry air and high voltage power supplies to control the wall thickness of each segment individually. The lengths of the segments are selected by adjusting the walls of the coating chambers, and also by adjusting the sizes of apertures in the walls.

Abstract: A component mixing catheter (2) includes a catheter shaft (4) having proximal and distal ends (6, 8) and defining first and second lumens (10, 12). The catheter shaft has an exterior opening (16) at or near its distal end (8) which is fluidly coupled to the first lumen. One or more connecting passages (14) fluidly connect the first and second lumens at a position (30) spaced apart from the exterior opening. The second component passes through the connecting passage and mixes with the first component at a mixing region (25) within the first lumen just prior to exiting the catheter at the exterior opening for maximum therapeutic effect or diagnostic accuracy.

Abstract: An adhesive device retains a medical tube, and particularly a naso-gastric tube, in relation to a patient with improved flexibility, strength and adhesion. The device includes a nose pad portion for attaching to a patient's nose and a tube attachment section for attaching to the naso-gastric tube. A substantially inelastic spine extends across a narrow or otherwise vulnerable neck portion, which connects the nose pad to the tube attachment section. The spine strengthens the retaining device against tensile and shear forces while allowing flexibility. At the same time, deflection of the spine does not cause internal elastic stresses sufficient to counter adhesion of the retainer to either the patient or the medical tube.

Abstract: A multi-catheter emboli containment system is disclosed in which a treatment chamber within a blood vessel is formed by at least two occlusion balloons on opposite sides of a stenotic lesion, thereby preventing emboli migration during the treatment procedure. Irrigation and aspiration are provided to remove emboli and debris from the chamber. The irrigation and aspiration can be provided through separate catheters, or, the catheters used to create the chamber, together with the catheter used to provide therapy to the stenosis can be used. The catheters are all sized so as to be concentric, slidably disposed with respect to one another, and able to be delivered into blood vessels less than 25 mm in diameter or even smaller.

Abstract: A catheter with several independent lumens extending longitudinally through the catheter for accepting probes and for introducing fluid through the catheter and into a body cavity is disclosed. The catheter outer body has a cross-sectional maximum outer dimension. The first lumen is circular in cross-section, and has a cross-sectional dimension of approximately half the maximum outer dimension of the catheter body. The first lumen is capable of accepting various probes, as well as allowing simultaneous fluid flow through the lumen. The second lumen is crescent-shaped in cross-section and occupies at least a quarter of an arc around the cross-section of the catheter body. The large cross-section of the second lumen allows for a high fluid flow rate through the lumen. The third lumen allows for inflation of an inflation balloon (when present), and the fourth lumen allows for the passing of a portion of an instrument along the length of the lumen.

Abstract: A catheter assembly for treatment of a stenosis in a lumen in a blood-carrying vessel comprising a first flexible elongate tubular member having proximal and distal extremities. A first inflatable balloon is coaxially mounted on the distal extremity of the first flexible elongate tubular member and has a main lumen and an aspiration lumen exiting through the distal extremity. A second flexible elongate tubular member has proximal and distal extremities and has a second inflatable balloon coaxially mounted on the distal extremity and has a blood perfusion lumen extending therethrough. The second flexible elongate tubular member is slidably mounted in the main lumen of the first flexible elongate tubular member. The first balloon is positioned so that it is adjacent to but proximal of the stenosis and is thereafter inflated to create a first occlusion in the lumen in the vessel. A negative pressure is created in the lumen in the vessel distal of the first balloon through the aspiration lumen.

Abstract: A method of concealing tattoos on a person's body includes the steps of adding various coloring pigments to a tattooing ink until a color which matches the person's skin color is achieved. The colored tattoo ink is brushed over the existing tattoo to effect a concealing of the tattoo without the necessity of laser surgery or other radical skin damaging activities. The tattoo ink may also be injected into the tattoo to provide a more permanent concealment. A kit for performing the method of concealment includes a skin color chart for assisting in color selection, and containers having supplies of tattooing ink and coloring pigments. Various swabs, brushes and disposable syringes are also included in the kit.

Abstract: A pencil-grip fine needle aspiration syringe holder for accurately placing a needle into a region using a single hand disposed close to the needle tip in a position of natural function, useable with a standard syringe. A body is provided for receiving a syringe barrel, and a slide is movably mounted to the body for engaging a syringe handle, for movement between a withdrawal position where a syringe plunger is in a compact position and a released position where the plunger is in an extended position. A finger engaging member is fixed to the body for grasping the holder in a pencil-grip manner, and a biasing member is coupled between the body and the slide for urging the slide toward the released position and the plunger toward the extended position.

Abstract: A connector/clamp assembly for a transfer set includes an inlet connector with a base, a shank extending from one end of the base and an I.V. tube extending from the opposite end of the base. The base interfits with a housing having opposite ends, a bottom wall and a pair of side walls extending from the bottom wall, so that the shank extends from one end of the housing and the tube extends along the bottom wall to the opposite end of the housing. A clamp is present in the housing opposite the tube and which is movable within the housing between a first position wherein the clamp collapses the tube against the housing bottom wall thereby blocking the tube lumen and a second position wherein the clamp does not collapse the tube sufficiently to appreciably occlude the lumen.

Abstract: An apparatus for the insertion of sterile implants comprising a cartridge having a body with a central bore. The body comprises at its proximal end a retention shoulder or hub adapted for retention by an insertion tool. The body further comprises a closure plug received in the proximal end of the bore that seals the bore and that has an exposed surface to engage a plunger rod from an insertion tool. The body still further comprises a sealed distal tip of decreasing diameter from the outer surface of the body that terminates in a point adapted for penetrating a pre-existing body orifice or for piercing tissue during insertion into a patient. The tip is frangible into a plurality of segments under pressure exerted by the distal end of the implant, allowing the implant to emerge from the cartridge.

Abstract: A needle device for the delivery of medicaments, insuflation or other medical devices, having a reciprocable needle sensitive to lack of resistance, whereupon such needle retracts, permitting a cannula therewith to provide access to the penetrated body.

Abstract: A syringe device for mixing two compounds is provided. The syringe device includes a vial having an opening and a centrally perforable stopper. The syringe device also includes a guide tube for guiding the injection end of the syringe between a withdrawn or storage position and an inserted position. The guide tube includes a second end for receiving the injection end of the syringe, which also includes a seal between the body of the syringe and the guide tube.

Abstract: An apparatus for repairing a wound in soft tissue includes an introducer trocar with a sharpened distal end and a hollow lumen. An elongated pin has a distal end, a proximal end and a central section. The pin is formed of compacted, hydrophilic, cross-linked collagen and introduced into the hollow lumen in a non-deployed state. An advancement member includes a distal end and is at least partially positioned in the hollow lumen. The advancement member advances the elongated pin out of the introducer trocar distal end and into a soft tissue structure in the pin's non-deployed state and across a wound in the soft tissue structure. The pin becomes deployed to a deployed state when the collagen in the pin begins to hydrolyze, anchoring the pin and the wound so that the wound can be healed quickly. This produces a maintenance of position for two non-continuous bodies of soft tissue relative to each other.

Abstract: An integrated nursing bottle and liquid medication dispensing apparatus enables precise and independent control of both the rate of administration of the medication, and the amount by which it is diluted before reaching the infant's mouth. A preferred embodiment utilizes a sleeve with a restricted tip for receiving a syringe that permits the optimal mixing of medicine and a diluting fluid in the nipple area of the bottle while minimizing the loss of fluid in the syringe tip, thus ensuring the easy and accurate administration of medicine dosages.