Abstract: A laminate balloon comprising at least two layers of separately oriented thermoplastic polymer material, which are coextensive over the body of the balloon. The two layers may be made of different polymer materials, including an underlying layer made of a low compliant, high strength polymer, such as PET, and an overlying layer of a softer and more flexible polymer material relative to the first polymer material, such as a polyester-polyether block copolymer. The balloon structures have an additive burst pressure, meaning that they are stronger than a single-layer reference balloon corresponding to the underlying polymer layer. The balloons are characterized by a combination of flexibility and surface softness which allows catheters to track down into lesions relatively easily, puncture resistance, abrasion resistance and refoldability, in addition to low compliance and high burst strength. The balloons may be prepared with generally linear or with stepped compliance profiles.

Abstract: A method is provided for eliminating surface imperfections on a medical device having a drug release coating including a therapeutic substance in a polymeric carrier disposed on at least a portion of the medical device. The medical device is preferably a stent including wire-like members interconnected to form struts with open interstices therebetween. A therapeutic substance incorporate into a polymeric carrier is disposed on the surface of the stent through which process imperfections including polymeric fibers, polymeric particles or other polymeric surface aberrations or imperfections are formed. This imperfections are eliminated by contacting the polymeric coating with a vaporized solvent for a specified period of time.

Abstract: A multilayer device comprised of at least one layer of material which is capable of absorbing liquid to thereby increase the volume of the layer, i.e., liquid swellable, and when bound to at least one non-absorbing or lesser absorbing layer of material causes deformation of the device upon liquid absorption.

Abstract: Devices and methods for increasing blood perfusion within the myocardium of the heart by wounding the myocardium and applying growth factors to promote vascularization. One method includes driving spikes into the myocardium from within the heart, with the spikes being formed of biodegradable material, containing releasable growth factors, and having lumens and side holes. An alternative method utilizes non-biodegradable spikes with lumens and side holes. Another method promotes vascularization by injecting angiogenic material into holes bored into the myocardium, leaving a patent hole. Another method includes injecting angiogenic material into the myocardium without boring, leaving no patent hole. The angiogenic material can be carried in a biodegradable adhesive. Revascularization of the myocardium is promoted in one method by externally wounding the heart and applying a patch including growth factors.

Abstract: In order to bypass a restriction in a parent vessel, a first site in a branch vessel branching from the aorta is accessed intraluminally. An occlusion is formed at the first site, and the aperture is formed in the branching vessel, intraluminally, proximal of the first site. An aperture is formed in the parent vessel distal of the restriction, and a lumen is formed which communicates between the branching vessel proximal of the occlusion, and the parent vessel distal of the restriction.

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: A method for installing a stent in a vessel utilizes a single balloon catheter for both low pressure predilation at a relatively small diameter to open the lesion sufficiently to allow insertion and deployment of the stent across the lesion and for subsequent high pressure embedding of the stent in the vessel wall. The same balloon catheter may also be employed to insert and deploy the stent. The balloons utilized in the method have a stepped compliance curve which allows for predilation at a low pressure and predetermined diameter and for high pressure embedding at a substantially larger diameter. The balloons may be provided with a configuration in which only a portion of the balloon has a stepped compliance curve while a further portion has a generally linear compliance profile. With such balloons high pressure treatment of the vessel wall areas not reinforced by the stent can be avoided despite the occurence of longitudinal shrinkage of the stent during expansion thereof.

Abstract: A method for making a biodegradable stent for insertion into a lumen, the method involves the casting of a film including a matrix of collagen IV and laminin, drying the film, casting a film containing polylactic acid onto the first dried film to form stent material, drying the material formed and forming the biodegradable material into a stent.

Abstract: Balloons for medical devices, particularly balloon angioplasty catheters, are made from particular block copolymer thermoplastic elastomers in which the block copolymer is made up of hard segments of a polyester or polyamide and soft segments of polyether; the polyester hard segments are polyesters of an aromatic dicarboxylic acid and a C.sub.2 -C.sub.4 diol; the polyamide hard segments are polyamides of C.sub.6 or higher carboxylic acids and C.sub.6 or higher organic diamines or of C.sub.6 or higher aliphatic .omega.-amino-.alpha.-acids, and the polyether soft segments are polyethers of C.sub.2 -C.sub.10, diols; the block copolymer has a low flexural modulus, namely less than 150,000 psi; the block copolymer has a hardness, Shore D scale, of greater than 60; and the percentage by weight of the block polymer attributable to the hard segments is between about 50% and about 95%. The polymers provide high strength, thin wall, compliant and semi-compliant balloons, which leads to a low profile catheter.

Abstract: A method for inhibiting restenosis including local application of an oxidizing agent to blood vessel walls. Preferred oxidizing agents include peroxides, most preferably hydrogen peroxide. Oxidizing agents can be delivered utilizing drug delivery balloon catheters. Preferred delivery catheters include an inflatable balloon having a perfusion lumen therethrough to allow for longer application periods. Oxidizing agents can be delivered either alone or in conjunction with radiation or stent delivery. One method includes local delivery of 0.1% hydrogen peroxide to a dilated stenosis wall for a period of 10 minutes at a rate of 0.5 cc per minute.

Abstract: A medical device for partial insertion into a patient and navigating passageways, channels, canals, cavities, and other interior parts of said patient, said medical device comprising an elongate body having an in the body segment which, in normal use, is inserted in the body of a patient. At least a portion of the in-the-body segment is provided with a lubricious coating. The coating displays a gradient of lubricity along the length of thereof.

Abstract: A method and composition for inhibiting restenosis. The composition includes an adhesive or polymeric material having a radioactive component dispersed therethrough. A biologically compatible adhesive including a radioactive material is applied to a vessel region where inhibition of restenosis is desired in a preferred method. In one composition, the radioactive material is admixed with the adhesive. In another composition, the radioactive material is chemically bonded to a polymeric adhesive. The adhesive is preferably cured in place. The radioactive material has a preferred half life of less than six months. In one method, the application of adhesive is followed by stent placement, leaving radioactive adhesive extending beyond both stent ends. The application can include forcing adhesive from a double walled balloon having a porous outer wall.

Abstract: Balloons for medical devices, particularly balloon angioplasty catheters, are made from particular block copolymer thermoplastic elastomers in which the block copolymer is made up of hard segments of a polyester or polyamide and soft segments of polyether; the polyester hard segments are polyesters of an aromatic dicarboxylic acid and a C.sub.2 -C.sub.4 diol; the polyamide hard segments are polyamides of C.sub.6 or higher carboxylic acids and C.sub.6 or higher organic diamines or of C.sub.6 or higher aliphatic .omega.-amino-.alpha.-acids, and the polyether soft segments are polyethers of C.sub.2 -C.sub.10, diols; the block copolymer has a low flexural modulus, namely less than 150,000 psi; the block copolymer has a hardness, Shore D scale, of greater than 60; and the percentage by weight of the block polymer attributable to the hard segments is between about 50% and about 95%. The polymers provide high strength, thin wall, compliant and semi-compliant balloons, which leads to a low profile catheter.

Abstract: A method for forming a balloon for a dilatation catheter involving the steps of extruding a segment of thermoplastic material, maintaining the center portion at a temperature below the glass transition of the thermoplastic material, drawing the segment to a predetermined length, wherein after the drawing the wall thickness of the center portion does not appreciably change, and expanding the segment in a mold to produce the balloon.

Abstract: A temporary stent comprises a coil of tubular thermoplastic material and a heating element inside the tubular material, or a film with a metal film resistive heating element coated thereon. A method of temporarily supporting the wall of a vessel comprises the steps of inserting a thermoplastic body having a first outer dimension less than the inside dimension of the vessel into the vessel to the desired support position; heating the thermoplastic above its softening transition temperature and expanding it to a second outer dimension larger than its first outer dimension; cooling the thermoplastic body to below its softening transition temperature while at its second outer dimension; allowing the cooled thermoplastic body to temporarily support the vessel; heating the thermoplastic above its softening transition temperature to soften the thermoplastic; and removing the softened thermoplastic body from the vessel.

Abstract: A stent includes a main body of a generally tubular shape for insertion into a lumen of a vessel of a living being. The tubular main body includes a substantially biodegradable matrix having collagen IV and laminin that enclose voids within the matrix. The tubular main body also includes a biodegradable strengthening material in contact with the matrix to strengthen the matrix. The tubular main body is essentially saturated with drugs.

Abstract: A method for installing a stent in a vessel utilizes a single balloon catheter for both low pressure predilation at a relatively small diameter to open the lesion sufficiently to allow insertion and deployment of the stent across the lesion and for subsequent high pressure embedding of the stent in the vessel wall. The same balloon catheter may also be employed to insert and deploy the stent. The balloons utilized in the method have a stepped compliance curve which allows for predilation at a low pressure and predetermined diameter and for high pressure embedding at a substantially larger diameter. The balloons may be provided with a configuration in which only a portion of the balloon has a stepped compliance curve while a further portion has a generally linear compliance profile. With such balloons high pressure treatment of the vessel wall areas not reinforced by the stent can be avoided despite the occurence of longitudinal shrinkage of the stent during expansion thereof.

Abstract: An inflatable balloon (14) for a catheter (10) includes a coating (15) which causes the balloon to prefer a predetermined, low profile configuration, such as a trifold configuration (40), when deflated. The balloon has a wall (13) which has an exterior polymeric coating (15). The coating (15) is set while the balloon is in the predetermined low-profile deflated configuration so that after inflation, the coating acts to urge the balloon to return to the low profile configuration as the balloon is deflated.

Abstract: A temporary stent comprises a coil of tubular thermoplastic material and a heating element inside the tubular material, or a film with a metal film resistive heating element coated thereon. A method of temporarily supporting the wall of a vessel comprises the steps of inserting a thermoplastic body having a first outer dimension less than the inside dimension of the vessel into the vessel to the desired support position; heating the thermoplastic above its softening transition temperature and expanding it to a second outer dimension larger than its first outer dimension; cooling the thermoplastic body to below its softening transition temperature while at its second outer dimension; allowing the cooled thermoplastic body to temporarily support the vessel; heating the thermoplastic above its softening transition temperature to soften the thermoplastic; and removing the softened thermoplastic body from the vessel.

Abstract: A method for forming a balloon for a dilatation catheter may utilize the steps of extruding a tubing preform of a polyester resin and then blowing the tubing into an oriented balloon, wherein the tubing preform is dried prior to blowing into the balloon form. Other process steps by which balloon cone and waist thicknesses may be reduced involve varying the axial tension and blowing pressure at several stages as a mold containing the balloon preform is dipped into a heating medium. Specifically, tubing of a thermoplastic material is placed in a mold and blown by pressurizing and tensioning the tubing and gradually dipping the mold into a heated heat transfer media so as to sequentially blow a first waist, a body and a second waist portion. The tubing is subjected to a relatively lower pressure while the body portion is blown than while the first and second waist portions are blown.