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 large diameter delivery catheter or sheath for percutaneous delivery of a contained and implantable medical device in the vasculature of a patient. The delivery catheter or sheath includes a reinforcement such as a flat wire coil with uniform spacing between the turns. The reinforcement is compression fitted about an inner, lubricous PTFE tube having a substantially uniform inner diameter of from 16 to 30 French. The delivery catheter or sheath further includes an outer tube of a heat formable polyamide material having a durometer of about 30 to 60 on the Shore D scale. The outer tube is heat formed and compressed through the spaces between the turns of the wire coil to mechanically connect to a roughened outer surface of the inner tube. A polymeric radiopaque marker tube may be positioned at the distal end of the coil and between the inner and outer tubes for radiographic visualization.

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 medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked 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 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. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

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 medical device (10) includes a catheter shaft (11) including inner and outer catheter shafts (12 and 14), and an expandable balloon (18) carried by the catheter shaft (11). The balloon (18) is made from an irradiation cross-linked 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 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. The cross-linking reactant can also be diallyl phthalate or meta-phenylene dimaleimide. Irradiation is carried out by exposure to an electron beam or to ultraviolet, X- or gamma radiation, preferably at a total fluence of about 0.5 to about 20 megarads.

Abstract: A flexible plastic material catheter having a distal tubular member portion with a greater than 75 weight percent loading of a radiopaque agent for radiographic viewing. The catheter comprises an elongated member having a proximal portion and a distal end portion with a flexible, radiopaque plastic material having a durometer lower than that of the proximal portion. The plastic material of the distal end portion comprises a homogeneous and evenly dispersed composition of a 20 weight percent base thermoplastic, elastomer material such as a polyether block amide and 80 weight percent loading of a radiopaque agent such as tungsten. This distal end portion plastic material exhibits a durometer of approximately 47 on the Shore D scale, whereas the polyether block amide material exhibits a durometer of approximately 40 on the Shore D scale. The flex modulus of the polyether block amide material is in a range of 23,000 to 75,000 pounds per square inch.