Abstract: The present invention provides a polymeric treatment for curved regions in shaft assemblies that increases curve retention without affecting the flexibility within these regions. More specifically, the present invention modifies the underlying crystalline morphology of a polymer in order to decrease crystal fracturing. In particular, the present invention treats polymeric materials suitable for catheter construction with a nucleating agent.

Abstract: A tubular extruded member particularly suitable for use in medical devices such as intravascular catheters and guide wires, wherein the extruded tubular member includes multiple layers having biaxial helical orientation in different directions. A counter-rotation extrusion process may be used to orient the layers in different biaxial helical directions. The counter-rotation extrusion process provides orientation in two different circumferential directions in addition to a longitudinal direction. By combining the dual direction or biaxial helical orientation with multiple layers, different layers of the tubular member may be tailored to have the desired mechanical properties.

Abstract: Balloon especially useful for dilatation of gastrointestinal lesions have a burst pressure of at least 9 atmospheres, a diameter at 3 atmospheres of about 5 mm or more, and an average compliance over the range of from 3 atmospheres to burst of at least 3% per atmosphere. Such balloons and balloons having other combinations of burst strength, compliance and diameter may be prepared by a method wherein a tubing of a thermoplastic polymer material is radially expanded under a first elevated pressure at an elevated temperature to form the balloon at a first diameter and then annealing the balloon at a second elevated temperature and a second pressure less than the first elevated pressure for a time sufficient to shrink the formed balloon to a second diameter less than the first diameter. The thermoplastic polymer material may be a block copolymer material. Catheters bearing balloons prepared by this method have low withdrawal force requirements, especially catheters used in through-the-scope applications.

Abstract: A medical device, at least a portion of which is composed of a polymeric material in which the polymeric material is a melt blend product of at least two different thermoplastic polymers, one of the thermoplastic polymers being a thermoplastic liquid crystal polymer (LCP) having a melting point of less than 250° C. The portion of the device made from the melt blend may be a catheter body segment or a balloon for a catheter. The LCP blends suitably also include a non-LCP base polymer having a melting point in the range of about 140° C. to about 265° C.

Abstract: A catheter having a catheter shaft and a medical balloon mounted thereon. The medical balloon having a non-inflated state and being inflatable to an inflated state. The medical balloon having a stent mounting region, with a stent being disposed about at least a portion of the stent mounting region. The stent mounting region having a middle portion, a first end portion adjacent to the middle portion and a second end portion adjacent to the middle portion. The middle portion having a middle portion diameter, the first end portion having a first end portion diameter, the second end portion having a second end portion diameter. In the non-inflated state the middle portion diameter being different from the first end portion diameter and the second end portion diameter, in the inflated state the middle portion diameter being substantially the same as the fist end portion diameter and the second end portion diameter.

Abstract: A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and/or higher inflation durability than balloons prepared from conventional parisons of the same material.

Abstract: An apparatus and method for molding balloon catheters is disclosed. The balloon may be molded by providing a polymeric tube within a mold having an interior cavity in the shape of the desired balloon. Microwave energy, which may be generated by a gyrotron, may then be directed toward the mold, to heat the polymeric material without heating the mold. Once heated, pressurized fluid may be injected into the tube to blow the polymeric material against the interior cavity whereupon the material can cool to form the balloon or can be further heatset by additional microwave energy and be cooled to form the balloon. In accordance with one embodiment, microwave energy can also be used without a mold to form a medical device.

Abstract: A tie layer insert is disclosed to aid in bond formation between an expandable balloon and a distal portion of a catheter shaft. The tie layer insert can be a single layer applied directly to the structural surfaces, or alternatively, the tie layer may be incorporated into a preformed polymeric insert. In the latter embodiment, the polymeric insert may include several layers of polymeric material. During the manufacturing process, the preformed polymeric insert is positioned between the distal portion of the expandable balloon and the catheter shaft. The entire distal region is then processed to form a sealably bonded expandable balloon to the distal end of the catheter shaft.

Abstract: A catheter having a catheter shaft and a medical balloon mounted thereon. The medical balloon having a non-inflated state and being inflatable to an inflated state. The medical balloon having a stent mounting region, with a stent being disposed about at least a portion of the stent mounting region. The stent mounting region having a middle portion, a first end portion adjacent to the middle portion and a second end portion adjacent to the middle portion. The middle portion having a middle portion diameter, the first end portion having a first end portion diameter, the second end portion having a second end portion diameter. In the non-inflated state the middle portion diameter being different from the first end portion diameter and the second end portion diameter, in the inflated state the middle portion diameter being substantially the same as the first end portion diameter and the second end portion diameter.

Abstract: A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and/or higher inflation durability than balloons prepared from conventional parisons of the same material.

Abstract: Balloons for use on medical devices such as catheter balloons are formed from polymer blend products which include a liquid crystal polymer (LCP), a crystallizable thermoplastic polymer, especially thermoplastic polyesters such as PET, and a compatabilizer. The compatabilizer may be an ethylene-maleic anhydride copolymer, an ethylene-methyl acrylate copolymer, an ethylene-methyl acrylate copolymer, an ethylene-methyl acrylate-maleic anhydride terpolymer, an ethylene-methyl-methacrylic acid terpolymer, an acrylic rubber, an ethylene-ethyl acrylate-glycidyl methacrylate terpolymer or a mixture of two or more such polymers.

Abstract: Medical devices such as catheters and balloons are formed from a thermoplastic polymer composition comprising a melt mixture product of at least one terminally reactive polymer and a chain extender.

Abstract: A percutaneous system for bypassing a restriction in a native vessel of a mammal having an aorta includes providing a graft having a body portion with a first end, a second end and a lumen therebetween. An aperture is formed in the aorta. The graft is inserted into the aorta and the first end of the graft is connected to the aorta about the aperture in the aorta. An aperture is then formed in the native vessel distal of the restriction. The second end of the graft is connected to the native vessel about the aperture therein such that the lumen in the graft communicates with the aorta and the native vessel.

Abstract: An inflatable medical balloon for multiple procedures, including angioplasty procedures, procedures for delivering medical devices, such as stents, and a method of making the catheter systems. The catheter system employs a balloon having a plurality of flexible portions and a combination of hard and soft portions.

Abstract: An inflatable medical balloon comprises a polymer matrix material and a plurality of fibers distributed in the matrix material. The plurality of fibers operatively adhere to the matrix material and provide reinforcement thereof. The fibers may be parallel or angularly oriented relative to the longitudinal balloon axis, and may be helically disposed thereabout. The fibers may be composed of material which has a greater tensile strength than the matrix material. The fibers may be microfibers formed by phase separation of a melt blend material during extrusion or polymer cores coextruded with the matrix material and surrounded thereby. The balloon may be formed of alternating layers of fiber-free polymer and layers of fiber-containing polymer.

Abstract: A catheter for placement of an in situ implant is provided. This catheter may include a first elongate shaft having a proximal end and a distal end, a second elongate shaft having a proximal end and a distal end, a first sharpened distal tip disposed at the distal end of the first shaft and a second sharpened distal tip disposed at the distal end of the second shaft. The first shaft and the second shaft may also be secured to one another at the distal end of the first shaft according to the invention. Still further, according to other teachings, the first sharpened distal tip may extend beyond the second sharpened distal tip in a catheter that practices the invention.

Abstract: A balloon catheter suitable for deploying a stent utilizes a balloon molded with a stepped diameter profile.

Abstract: A medical balloon composed of a micro-composite material which provides for radial expansion of a balloon to a predetermined extent, but which has minimal longitudinal growth during balloon inflation. The micro-composite material includes a fibril component, a matrix component, and optionally, a compatibilizer. The fibril component may preferably be liquid crystal polymer fibers randomly scattered through out the balloon material. The liquid crystal polymers are created by extrusion at high speed. An alternative fibril component may be a PET fibers which are uniformly spaced about the balloon material and extend through out the length of the balloon material tube.

Abstract: A method for delivering a therapeutic implant to a tissue is provided. This method includes providing an elongate catheter having a distal end including a lumen, providing a carrier including a therapeutic agent, placing the carrier including the therapeutic agent into the lumen, advancing the distal end of the catheter to the tissue, and depositing the carrier including the therapeutic agent into the tissue.

Abstract: Markers that are visible under magnetic resonance imaging (MRI) and fluoroscopy and related medical devices are disclosed.