Abstract: Catheters adapted for use in small body vessels are described. A catheter includes an elongate shaft having a main body that defines first and second lumens. An inner tubular member is disposed in the second lumen and is formed of a material that has a stiffness that is greater than a stiffness of the material forming the main body and that has an elastic modulus greater than or equal to about 400 MPa.

Abstract: A sheath for deploying a medical device to a target site in the body of a patient. A tubular inner liner has a proximal portion, a distal portion, and an outer surface. An outer jacket has a proximal portion, a distal portion, and an inner surface. A reinforcing member is received within a length of the outer jacket. The outer jacket is positioned longitudinally around the inner liner and bonded to the outer surface of the liner. The reinforcing member, which may be a triaxial braid, or an encapsulated longitudinal reinforcing wire, extends along the outer jacket length and is configured for inhibiting elongation of the sheath upon deployment of the device.

Abstract: A medical balloon (10) of a balloon catheter assembly (70) includes a balloon wall (22) formed of at least two layers (30, 32). The first layer (30) is made of an impervious polymeric material. The second layer (32), which is integral with the first layer (30) is made of a radiopaque and/or echogenic material and a polymeric material. In the preferred embodiment, there is provided 60 to 80% by weight of radiopaque material in the second layer (32). It has been found that these concentrations of radiopaque material provide good visibility of the balloon under ultrasonic imaging.

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 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 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: A large diameter, flexible, kink-resistant, 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, which is compression fitted about an inner, lubricous PTFE tube. The delivery catheter or sheath further includes an outer tube of a heat formable polyamide material which 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. A side port may also be positioned thereat for the infusion of contrast media.

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 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 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 large diameter, flexible, kink-resistant, 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, which is compression fitted about an inner, lubricous PTFE tube. The delivery catheter or sheath further includes an outer tube of a heat formable polyamide material which 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. A side port may also be positioned thereat for the infusion of contrast media.

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: 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 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 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.