Abstract: Medical devices such as stents, stent grafts, and balloon catheters include a coating layer applied over a modified exterior surface of the medical device. The modified exterior surface comprises an exterior surface of the medical device subjected to a surface modification that decreases a surface free energy of the exterior surface before application of the coating layer an exterior surface. The coating layer comprises a hydrophobic therapeutic agent and at least one additive. The modified exterior surface may affect the release kinetics of the drug from the device, the crystallinity of the drug layer, the surface morphology of the coating and particle shape, or the particle size of drug of a therapeutic layer in the coating layer. For example, the effects caused by the modified exterior surface may increase the retention time and amount of therapeutic agent in tissue.

Abstract: Medical devices such as stents, stent grafts, and balloon catheters include a coating layer applied over a modified exterior surface of the medical device. The modified exterior surface comprises an exterior surface of the medical device subjected to a surface modification that decreases a surface free energy of the exterior surface before application of the coating layer an exterior surface. The coating layer comprises a hydrophobic therapeutic agent and at least one additive. The modified exterior surface may affect the release kinetics of the drug from the device, the crystallinity of the drug layer, the surface morphology of the coating and particle shape, or the particle size of drug of a therapeutic layer in the coating layer. For example, the effects caused by the modified exterior surface may increase the retention time and amount of therapeutic agent in tissue.

Abstract: An antimicrobial accessory may include a polymer an antimicrobial mixed in the polymer, and an antioxidant. The antioxidant may include, for example, at least one of citric acid, maltol, kojic acid, malic acid, or vitamin A. In some examples, the antioxidant may include an ascorbate peroxidase in combination with ascorbic acid, a glutathione peroxidase in combination with glutathione, or a superoxide dismutase in combination with a metal such as Ni, Cu, Mn, or Fe. In some examples, the antimicrobial accessory may include at least three polymer layers. For example, the antimicrobial accessory may include a first layer comprising a biodegradable polymer and an antimicrobial. The antimicrobial accessory may further include a sacrificial diffusion layer formed on a surface of the first layer. The sacrificial diffusion layer may include a biodegradable polymer, which may be the same biodegradable polymer as in the first layer or may be a different biodegradable polymer.

Abstract: Medical balloons comprising a predetermined pattern of conductive materials and methods of making the same.

Abstract: A medical device such as a catheter, stent or balloon, is formed by depositing a radiation curable composition on a form made of ice or wax. The deposited composition may be cured by irradiation, suitably with UV light. Complex structures can be built up if the deposition or curing is achieved imagewise. Compositions which photocure to polyester, polyamide or polyimide may be employed. A particular structure is a balloon for a rapid exchange catheter which has a guide wire lumen passing through the balloon cone walls.

Abstract: A medical device in which a melt processed part has different crystallized properties at different locations. The part is formed of a polymer composition by inclusion a of polymer crystallization modifier in the composition making up at least a portion of such part, the amount of the polymer crystallization modifier is varied at different locations on the part in accordance with the desired difference in crystallization behavior.

Abstract: A catheter for crossing an occluding lesion with an inflatable balloon and dilating the lesion includes an inner tube that defines a longitudinal axis. The balloon includes a distal section that is bonded to the tube's distal end, a working section, and a conically shaped distal transition section connecting the working and distal section. A plurality of rigid ribs are spaced around the circumference of the balloon near the catheter's distal end. Each rib includes a first elongated portion attached to the balloon's distal section and aligned substantially parallel with the longitudinal axis. A second portion extending from the first portion and at an angle thereto is attached to and lies along the surface of the balloon's distal transition section. The plurality of ribs combine to simulate a stiff, tapered surface that can be wedged into the occluding lesion to create a passageway to cross the lesion with the balloon.

Abstract: An antimicrobial accessory may include a polymer an antimicrobial mixed in the polymer, and an antioxidant. The antioxidant may include, for example, at least one of citric acid, maltol, kojic acid, malic acid, or vitamin A. In some examples, the antioxidant may include an ascorbate peroxidase in combination with ascorbic acid, a glutathione peroxidase in combination with glutathione, or a superoxide dismutase in combination with a metal such as Ni, Cu, Mn, or Fe. In some examples, the antimicrobial accessory may include at least three polymer layers. For example, the antimicrobial accessory may include a first layer comprising a biodegradable polymer and an antimicrobial. The antimicrobial accessory may further include a sacrificial diffusion layer formed on a surface of the first layer. The sacrificial diffusion layer may include a biodegradable polymer, which may be the same biodegradable polymer as in the first layer or may be a different biodegradable polymer.

Abstract: An antimicrobial accessory may include a polymer an antimicrobial mixed in the polymer, and an antioxidant. The antioxidant may include, for example, at least one of citric acid, maltol, kojic acid, malic acid, or vitamin A. In some examples, the antioxidant may include an ascorbate peroxidase in combination with ascorbic acid, a glutathione peroxidase in combination with glutathione, or a superoxide dismutase in combination with a metal such as Ni, Cu, Mn, or Fe. In some examples, the antimicrobial accessory may include at least three polymer layers. For example, the antimicrobial accessory may include a first layer comprising a biodegradable polymer and an antimicrobial. The antimicrobial accessory may further include a sacrificial diffusion layer formed on a surface of the first layer. The sacrificial diffusion layer may include a biodegradable polymer, which may be the same biodegradable polymer as in the first layer or may be a different biodegradable polymer.

Abstract: A catheter for crossing an occluding lesion with an inflatable balloon and dilating the lesion includes an inner tube that defines a longitudinal axis. The balloon includes a distal section that is bonded to the tube's distal end, a working section, and a conically shaped distal transition section connecting the working and distal section. A plurality of rigid ribs are spaced around the circumference of the balloon near the catheter's distal end. Each rib includes a first elongated portion attached to the balloon's distal section and aligned substantially parallel with the longitudinal axis. A second portion extending from the first portion and at an angle thereto is attached to and lies along the surface of the balloon's distal transition section. The plurality of ribs combine to simulate a stiff, tapered surface that can be wedged into the occluding lesion to create a passageway to cross the lesion with the balloon.

Abstract: A medical device in which a melt processed part has different crystallized properties at different locations. The part is formed of a polymer composition by inclusion a of polymer crystallization modifier in the composition making up at least a portion of such part, the amount of the polymer crystallization modifier is varied at different locations on the part in accordance with the desired difference in crystallization behavior.

Abstract: A medical device in which a melt processed part has different crystallized properties at different locations. The part is formed of a polymer composition by inclusion a of polymer crystallization modifier in the composition making up at least a portion of such part, the amount of the polymer crystallization modifier is varied at different locations on the part in accordance with the desired difference in crystallization behavior.

Abstract: A catheter for crossing an occluding lesion with an inflatable balloon and dilating the lesion includes an inner tube that defines a longitudinal axis. The balloon includes a distal section that is bonded to the tube's distal end, a working section, and a conically shaped distal transition section connecting the working and distal section. A plurality of rigid ribs are spaced around the circumference of the balloon near the catheter's distal end. Each rib includes a first elongated portion attached to the balloon's distal section and aligned substantially parallel with the longitudinal axis. A second portion extending from the first portion and at an angle thereto is attached to and lies along the surface of the balloon's distal transition section. The plurality of ribs combine to simulate a stiff, tapered surface that can be wedged into the occluding lesion to create a passageway to cross the lesion with the balloon.

Abstract: An iontophoresis electrode (10) is disclosed including a backing layer (22) formed of PVC or similar material including plasticizers providing softness and conformability and a conductive layer (18) formed of carbon or similar polymer material having electrical characteristics which are negatively affected with the migration of the plasticizers. A barrier layer (26) is provided to prevent the undesired migration of plasticizers from the backing layer (22) into the conductive layer (18). In one preferred form, the barrier layer (26) is a sacrificial layer, such as of identical construction as the conductive layer (18), for acceptance of the migration of the plasticizers. In another form, the barrier layer (26) is an impermeable layer formed of material in which the plasticizer is immiscible so as to prevent the migration of the plasticizers.

Abstract: Disclosed is a dilatation balloon having a single layer containing polyesteretheramide copolymer. The dilatation balloon may also contain polyamide and/or additional polymers, and may contain substantially no polyetheramide having substantially no ester linkages.

Abstract: A stent delivery device having a pair of balloons at a proximal end of a catheter and having separate lumens for selectively inflating the respective balloons. The outer balloon is relatively compliant and the inner balloon is relatively non-compliant. A central lumen is provided for a guide wire. A stent is carried by the delivery device within an axially retractable sheath at the distal end of the catheter and is deployed by retraction of the sheath and inflation of the compliant balloon, and the stent is subsequently expanded by inflation of the non-compliant balloon.

Abstract: A stent delivery device having a pair of balloons at a proximal end of a catheter and having separate lumens for selectively inflating the respective balloons. The outer balloon is relatively compliant and the inner balloon is relatively non-compliant. A central lumen is provided for a guide wire. A stent is carried by the delivery device within an axially retractable sheath at the distal end of the catheter and is deployed by retraction of the sheath and inflation of the compliant balloon, and the stent is subsequently expanded by inflation of the non-compliant balloon.

Abstract: An expander member for a balloon catheter to be used in stent delivery applications comprises a double-walled tubular member that is adapted for attachment to a distal end portion of an elongated, flexible, tubular catheter body. The outer wall is preferably a polyamide, such as Nylon-12, and the inner wall is PET. By properly controlling the percentage of the polyamide relative to the PET content, the distension characteristics of the resulting expander member can be tailored to fall in a range less than 15 percent. The outer Nylon-12 layer provides the expander member with high abrasion resistance. By appropriately temperature annealing the expander member, any tendency toward winging upon deflation thereof is reduced.