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 and rotatable introducer sheath (10) for percutaneous delivery of a contained and implantable medical device in the vasculature of a patient. The introducer sheath includes a reinforcement such as a flat wire coil (23) fitted about an inner, lubricous material such as polytetrafluoroethylene tube (22). A wire braid (25) is placed around the coil to give good transfer of rotational forces. An outer tube (27) of a heat formable polyamide material is heat formed and compressed through the spaces between the wires of the braid and turns of the wire coil to mechanically connect the outer tube to the roughened outer surface of the inner tube. The durometer of the outer tube can be varied to effect the flexibility of the sheath. A radiopaque marker (42) is positioned at the distal end of the coil and around the inner tube for radiographic visualization.

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 (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, 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 there at for the infusion of contrast media.

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: An introducer sheath (30) having a short distal tip section (34,40) that is highly radiopaque. The distal tip section may be of FEP with 20% to 75% by weight tungsten particulate filler, and may be initially a separate member (40) and bonded to the sheath shaft distal end (32).

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.