Abstract: A method of forming a reinforced tubular medical device in a continuous operation, and a medical device formed by the continuous method. An elongated core capable of movement about a line is provided. An elongated tubular member is formed around a moving length of the core by extruding a coating of a functionalized polymer around the moving core length, applying a reinforcing member to an outer surface of the functionalized polymer coating along the moving length, and extruding a polymeric outer jacket over the functionalized polymer and reinforcing member along the moving length, such that a bond is formed between the functionalized polymer and the polymeric outer jacket. The elongated tubular member is cut to desired length to form the tubular medical device, and the core is removed from the device.

Abstract: A reinforced catheter or sheath includes an inner tube manufactured via an extrusion process from a mixture of thermoplastic and hollow glass beads. The resultant tube exhibits an inner goose bump surface that defines a central lumen. A reinforcement, such as a braid and/or coil is attached to at least a segment of the outer surface of the inner tube. A second tube of thermoplastic is extruded over at least a portion of the reinforcement. The inner goose bump surface exhibits a net low coefficient of friction comparable to that of polytetrafluoroethylene (PTFE).

Abstract: An apparatus for an improved high pressure medicinal dispenser is disclosed. The high pressure dispenser may include a handle (26), a chamber (18), a threaded region, a threaded rod (14), and a knob (20). The high pressure dispenser may have at least one insert-molded component. A threaded insert providing the threaded region may be insert-molded into the handle or the threaded rod may be insert-molded into the knob, or both. The dispenser may have a handle made of hard plastic and overmolded soft rubber material. The dispenser also may have a ribbed knob having at least one longitudinal rectangular cavity. Furthermore, the dispenser may have a chamber that has an interior concave surface and an interior convex surface between the interior cylindrical surface of the chamber and a nozzle. The chamber may have at least one tab or notch dimensioned to engage with at least one corresponding notch or tab on the handle.

Abstract: A catheter assembly is provided with a stress relief collar for relieving stress due to differences in rigidities of a catheter and coupled fitting. The stress relief collar is provided with an integral clip of the same or a similar soft material. The catheter can be coiled and held in the clip, the flexibility of the latter making it easy to fit and remove coils therefrom with little risk of damage to the catheter.

Abstract: A catheter having a non uniform wall thickness comprising first and second wall regions is described. The first region is thicker than the second region and at least a part of the first region comprises a material having a lower stiffness modulus than the second region. Typically, the ratio of stiffness between the first region and the second region is less than 1.25:1 and preferably approximately 1:1. The first region may comprise the same material as the second region but having a different formulation so that the stiffness modulus is altered. Alternatively, the regions may comprise different materials. The lower modulus material is coextruded into at least a part of the broadest/thicker cross sectional region(s).

Abstract: A medical device is provided. The device includes a cannula with a lumen defined therethrough and an upper portion, a right side portion, a bottom portion, and a left side portion each substantially equally spaced from their respective neighboring portion around the circumferential surface of the cannula. The cannula additionally includes a plurality of apertures disposed through the distal end portion to provide communication from the lumen and a visually perceptible indicator that is configured to allow the cannula to be positioned at an appropriate rotational position within the patient.

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: A medical device is provided. The medical device includes a sheath with an extended distal end portion, a proximal end portion, and a lumen defined therethrough. A handle is fixedly connected to the proximal end portion of the sheath, the handle includes an operator that is translatable between a first position and a second position. A flow path is defined within the handle in fluid communication with the proximal end portion of the sheath, wherein the operator is configured to substantially block the flow path in a second position and allow flow therethrough in a first position. The flow path includes a portion that is configured to communicate with a remote source of suction. The handle additionally includes a second inlet portion configured to receive a tool therethrough and allow the tool to extend through the lumen of the sheath.

Abstract: A disposable access sheath having a deflectable tip is provided. The access sheath is very flexible and allows a physician or other medical professional to provide diagnostic or therapeutic services to a remote body cavity. The access sheath has a deflectable tip that is able to bend at least 90° or 180° or more. This flexibility allows the physician or medical professional to make a very tight turn to visualize or treat the body cavity being treated. The access sheath may include a visualization system, a working channel, an irrigation channel, or other desirable features. The access sheath may include an interface at the proximal end of the working channel for insertion of an instrument for diagnosis or treatment of a human or mammalian patient.

Abstract: A medical device (110) including a catheter shaft (111) and a unitarily and continuously formed portion (108) having a varying durometer, and optionally including an expandable balloon (18, 118). One or both of the unitarily and continuously formed portion (108) and the balloon (18, 118) are made from an irradiation cross-linked or cross-linkable mixture of a polyamide elastomer and at least one additional cross-linking reactant. The polyamide elastomer can be a polyester amide, a polyether ester amide or a polyether amide, and is preferably a nylon block copolymer. The aromatic molecule can be 1,3,5 triethyl benzene; 1,2,4 triethyl benzene; and 1,3,5 triisopropyl benzene. The cross-linking reactant can be: (a) a difunctional material, (b) a trifunctional material, (c) a tetrafunctional material, or (d) an aromatic molecule containing at least two ring substituents, each of the ring substituents having labile hydrogens at a benzylic site therein.

Abstract: A method and apparatus for an improved luer fitting connector, in one embodiment, has a luer fitting connector including a male or female luer fitting member and a locking member. The locking member may have at least one of a skeletal handle, a finlike handle, a cavity grip, and an undulating grip. The luer fitting connector also may include a male or female luer fitting member having a conical restraining surface and a locking member having a plateau shaped protrusion. A method of assembly of luer fitting connector members may include providing a male or female luer fitting member having a conical restraining surface and providing a locking member having a plateau shaped protrusion. The method also may include mounting the locking member upon the male or female luer fitting member from the rear.

Abstract: Catheters having an overmolded hub are disclosed. The overmolded catheter hubs may include one or more access hubs that are overmolded with an overmold material. The catheter hub may also be formed as a single piece from the overmold material. The overmolded construction can result in a stronger bond between the catheter body and the hub and can provide for access hubs having sufficient clarity for the observation of air bubbles in a contained fluid. The disclosed catheter hubs may also demonstrate improved balloon deflation rates when utilized with a catheter body having a distal balloon.

Abstract: A pressure injection syringe with an actuator that includes a plunger for pressurizing viscous fluid material within a chamber. The plunger distal tip includes a high pressure seal defined by a seal member within a seal seat. The high pressure seal is viscoselective to permit air passage therepast for aspiration, and to prohibit viscous material passage therepast during actuation of the actuator wherein high pressure is applied to the material within the chamber. The viscoselective seal may be defined for example by small axial openings in the seal seat that permit aspiration of air therepast during initial plunger insertion into the chamber, but fluid escape is prohibited by the seal member when the seal member is pressed firmly against a collar of the plunger proximally adjacent the seal seat by initial engagement of the seal member with the viscous material, thus completely sealing the chamber at the proximal end thereof.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements that extend along a surface of a balloon. Each dilation element is connected to an outer surface of the balloon by a connector. The connector is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements does not become absorbed into the wall of the final blow molded balloon, thereby maintaining the structural integrity of each of the dilation elements.

Abstract: A catheter assembly includes a multi-lumen catheter and fluid supply apparatus for supplying fluid to said multi-lumen catheter. The fluid supply apparatus includes an inlet element for coupling to a supply of catheter fluid, a plurality of fluid outlet elements arranged to be each coupled to a respective lumen of the catheter and a flow splitter arranged between the inlet element and the outlet elements. The flow splitter is able to split or divert flow of fluid from the inlet to at least one of the plurality of outlets. For this purpose, the preferred embodiment includes a gate for directing fluid flow to one or more of the outlet elements. There may also be provided a diffuser and a nozzle.

Abstract: A catheter having a non uniform wall thickness comprising first and second wall regions is described. The first region is thicker than the second region and at least a part of the first region comprises a material having a lower stiffness modulus than the second region. Typically, the ratio of stiffness between the first region and the second region is less than 1.25:1 and preferably approximately 1:1. The first region may comprise the same material as the second region but having a different formulation so that the stiffness modulus is altered. Alternatively, the regions may comprise different materials. The lower modulus material is coextruded into at least a part of the broadest/thicker cross sectional region(s).

Abstract: The present invention provides a method of manufacturing a flexible tube. The method includes the steps of providing a source of material to be extruded and forming a tubular member with an extrusion die. The extrusion die includes a radially and outwardly extending tooth configured to define a protrusion upon the outer surface of the tubular member. The method further includes the step of rotating the tubular member after exiting the extrusion die such that the protrusion forms a helical profile along the length of the tubular member.

Abstract: A method of characterizing phase transformations of a shape memory material specimen entails recording data from the specimen during heating and cooling. The temperature of the specimen is changed in a first direction to a first temperature sufficient to define a first inflection and a second inflection in the data being recorded. The temperature of the specimen is changed in a second direction to a second temperature sufficient to define a third inflection in the data. The third inflection is formed by overlapping primary and secondary sub-inflections. The temperature of the specimen is changed in the first direction to a third temperature sufficient to define the first inflection but not sufficient to define the second inflection. The temperature of the specimen is then changed in the second direction to a fourth temperature sufficient to define the secondary sub-inflection in the data being recorded.

Abstract: A method and apparatus provide a luer fitting connector/adapter that acts as a modified-to-standard size converter piece. The adapter may complete a fluid tight medical system. The adapter may have one end having at least one non-standard sized luer fitting dimension. The non-standard end of the adapter may sealingly interconnect with a luer fitting member having a corresponding non-standard sized dimension. As a result, the adapter and luer fitting member may be directly interconnected with one another while remaining incompatible with standard sized luer fittings. Using the adapter may facilitate preventing the inadvertent direct interconnection of standard sized luer fitting members intended for different purposes, such as the delivery of a feed paste or a medication to a desired location within a patient. The adapter may be directly or indirectly interconnected with a syringe nozzle to facilitate flushing the medical system or a portion thereof.