Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein a fluid connection is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: A catheter for exchanging heat with a body fluid is disclosed. The catheter includes a main shaft and a heat exchange region having a plurality of heat exchange elements each having a length and opposed ends. Each of the elements is attached on at least one of its ends to the shaft and disposed so that when inserted in a fluid body cavity having body fluid therein, the body fluid may circumferentially surround each heat exchange element along a portion of the length of the heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes the hollow lumen within each of heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds that are in fluid communication with fluid flow paths within the shaft. Alternatively, the heat exchange elements may be connected at only one point and be permitted to float in a proximal or distal direction with respect to the catheter.

Abstract: A catheter for exchanging heat with a body fluid is disclosed. The catheter includes a main shaft and a heat exchange region having a plurality of heat exchange elements each having a length and opposed ends. Each of the elements is attached on at least one of its ends to the shaft and disposed so that when inserted in a fluid body cavity having body fluid therein, the body fluid may circumferentially surround each heat exchange element along a portion of the length of the heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes the hollow lumen within each of heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds that are in fluid communication with fluid flow paths within the shaft. Alternatively, the heat exchange elements may be connected at only one point and be permitted to float in a proximal or distal direction with respect to the catheter.

Abstract: A multilayer high strength balloon for a dilatation catheter is provided. The balloon comprises a plurality of balloon layers, including an inner layer which has a cylindrical midportion, a cone at each end, and necks at the ends of the cones, and at least one additional layer which has the cylindrical midportion and cones. Each layer is formed from a polymeric material, and perhaps an inelastic, biaxially oriented, thermoplastic material. Preferably, one or more of the balloon layers is blow molded and stretched to biaxially orient the material to form a very high strength layer. The layers have differing lengths along the catheter to which the multilayer balloon is coupled. The multilayer balloon resulting from the plurality of balloon layers, of which one or more has been biaxially oriented, is stronger than a single layer balloon of the same finished diameter which has been made from the same material with comparable thickness.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein a fluid connection is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: A multilayer high strength balloon for a dilation catheter is provided. The balloon comprises a plurality of balloon layers, including an inner layer which has a cylindrical midportion, a cone at each end, and necks at the ends of the cones, and at least one additional layers which have the cylindrical midportions and cones. Each layer is formed from an inelastic, polymeric material, and perhaps an inelastic, biaxially oriented, thermoplastic material. Preferably, one or more of the balloon layers is blow molded and stretched to biaxially orient the material to form a very high strength layer. The multilayer balloon resulting from the plurality of balloon layers, of which one or more has been biaxially oriented, is stronger than a single layer balloon of the same finished diameter which has been made from the same material with comparable thickness.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

Abstract: Multi-lumen balloons for use as or in conjunction with balloon dilation catheters, and methods for making such balloons, are disclosed.

Abstract: A variable stiffness balloon dilatation catheter is disclosed in which one or more polymeric sleeves are heat-shrunk around portions of an inner tubular element so as to form stiffening bands that provide variable stiffness longitudinally along the catheter.

Abstract: Sterile disposable coverings for endoscopes and similar optical medical instruments are disclosed together with a method for preparing such coverings. By forming a heated polymeric film with a mandrel of appropriate shape and dimensions, relatively long-length, very small diameter, closely-fitting, thin-walled sleeves are produced, each having a thin, substantially inelastic, optically transparent window formed continuously integral with the sleeve at or proximate to the closed, distal end of the sleeve.

Abstract: An integral, single-piece, high-strength, thin-walled, inflatable catheter is disclosed. The catheter has one end partially or entirely closed, and is at least uniaxially oriented along its entire length. The method and apparatus for making the catheter is also disclosed. The catheters of this invention have a calculated radial tensile strength of about 10,000 psi or greater at every point along the catheter.

Abstract: A balloon for a dilatation catheter is formed to define relatively thin cone and neck segments at the opposite ends of the balloon by forming the balloon in a plurality of separate very thin layers. The balloon is built up from a plurality of layers including an inner layer which defines a complete balloon having a cylindrical midportion, cones at its ends and necks at the ends of the cones. Each successive outer layer is trimmed to be shorter than the next adjacent innermost layer, the trimming being effected in the region of the cones. The composite balloon thus formed has a staggered wall thickness in the region of the cones as to define a cone that is approximately uniform in wall thickness in a direction extending toward the neck region. The resulting balloon will be better adapted to collapse to a low profile about the catheter shaft on which it is mounted.

Abstract: Multi-lumen balloons for use as or in conjunction with balloon dilation catheters, and methods for making such balloons, are disclosed.

Abstract: Sterile disposable coverings for endoscopes and similar optical medical instruments are disclosed together with a method for preparing such coverings. By forming a heated polymeric film with a mandrel of appropriate shape and dimensions, relatively long-length, very small diameter, closely-fitting, thin-walled sleeves are produced, each having a thin, substantially inelastic, optically transparent window formed continuously integral with the sleeve at or proximate to the closed, distal end of the sleeve.

Abstract: A low molecular weight, flexible, biaxially oriented, dilatation catheter balloon comprising oriented polyethylene terephthalate, and having a calculated radial tensile strength of greater than about 25,000 psi.

Abstract: An adjustable-length balloon dilatation catheter apparatus and a method for using the same are disclosed wherein an adjustable sheath is externally manipulated to partially surround and contain the dilatation balloon segment of the catheter while the catheter and balloon segment are in situ during a treatment procedure. By sliding the sheath forward or backward to expose a predetermined length of the balloon segment prior to inflating the balloon, the catheter apparatus of this invention is useful in medical procedures requiring balloons of varying lengths.

Abstract: A balloon dilation catheter having a biaxially oriented, flexible, polymeric balloon having a wall thickness to diameter ratio of less than 5.0.times.10.sup.-3 and a radial tensile strength greater than 35.000 psi.

Abstract: A balloon dilatation catheter having a balloon at its distal end includes a distal segment having a collapsible outer diameter. The distal segment includes an inner shaft and a generally coaxial outer surrounding sleeve formed from a very flexible, thin wall, high-strength polymeric material. The balloon is formed integrally with the sleeve and is collapsible about the shaft together with the sleeve. The distal segment of the catheter exhibits a high degree of trackability over a guidewire through tortuous blood vessels. When in its collapsed configuration, the distal segment of the catheter defines a reduced profile which is less obstructive to blood flow through the blood vessel containing the catheter distal segment, such as a coronary artery. In a modified embodiment of the invention, the flexible thin wall sleeve extends over a greater length of the catheter and may extend to the full length of the catheter.