Abstract: An implantable medical device is disclosed having a helical construct including a set of spiral coils for local in vivo application of a therapeutic substance in a biological lumen. The helical construct is configured to apply less than 0.75 Bar of pressure to the biological lumen wall. The helical construct can have at least two sets of spiral coils having opposing helical directions. The device can be used for the treatment of vascular disorders such as restenosis and vulnerable plaque.

Abstract: Pro-healing agent formulation compositions, methods and treatments for enhancing vascular healing are disclosed herein. In some embodiments, a pro-healing agent is encapsulated, suspended, disposed within or loaded into a biodegradable carrier for sustained-release delivery to a denuded or damaged endothelium treatment area in a blood vessel. In some applications, the pro-healing agent can accelerate re-endothelialization of a denuded vascular region. In some applications, the pro-healing agent can assist in the regaining of endothelium functionality. The formulation can be delivered by a delivery assembly such as an infusion catheter, a porous balloon catheter, a needle injection catheter, a double balloon catheter or the like.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: A method of modifying a medical device such as a stent with nano-constructs is disclosed. The method comprises applying a first fluid to the stent; immersing the stent being wet from the first fluid into a second fluid having a suspension of nano-constructs; and removing the stent from the second fluid and allowing the first and second fluid to be removed such that the nano-constructs are carried by the stent for in vivo application of the constructs to a target location of a mammalian subject. The nano-constructs can be attached to the surface of the stent, can be attached to a surface of the coating of the stent, can be embedded into the stent, or can be embedded into the coating.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: A catheter having a mandrel secured to the catheter or constrained within a dedicated lumen. In one embodiment, the catheter has an inner tubular member and an outer tubular member with a sidewall configured to define a mandrel lumen longitudinally along an inner surface of the outer tubular member or along an outer surface of the inner tubular member. The mandrel lumen may be configured to allow the mandrel to be exchanged to adjust the handling characteristics of the catheter. The mandrel may occupy an intermediate portion of the catheter shaft, or may extend from the proximal end to within proximal or distal shaft sections of the catheter. In coronary artery applications, the mandrel is configured to support the catheter as it bends through the aortic arch and enters the coronary artery.

Abstract: An implantable medical device is disclosed having a helical construct including a set of spiral coils for local in vivo application of a therapeutic substance in a biological lumen. The helical construct is configured to apply less than 0.75 Bar of pressure to the biological lumen wall. The helical construct can have at least two sets of spiral coils having opposing helical directions. The device can be used for the treatment of vascular disorders such as restenosis and vulnerable plaque.

Abstract: A catheter configured for delivering an agent to a patient's vessel wall, having self-expanding frame, and a method of delivering an agent to a patient's vessel wall. A first catheter has an elongated shaft with an agent delivery lumen and self-expanding frame on a distal shaft section formed of plurality of hollow tubes having joined first ends and free second ends, the free end of each hollow tube having an agent delivery port in fluid communication with the shaft agent delivery lumen and having a hooked tip configured for penetrating the vessel wall in the expanded configuration. Another catheter has a frame around the outer surface of a lining member such as a balloon or a tubular sleeve, such that the frame expanded against the vessel wall and the lining member together define a plurality of pockets between the vessel wall and the outer surface of the lining member.

Abstract: A bifurcated catheter having a branched distal shaft section and one or more porous or nonporous balloons, and combinations thereof, which is configured for delivery of an agent to a patient's bifurcated body lumen. Another aspect of the invention is directed to a method of delivering an agent to a patient's body lumen which facilitates maximizing the efficiency of drug uptake into the tissue at the desired site within the patient's body lumen.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by decreasing the inner diameter of a first end section of a polymeric tube, so that the tube has a reduced diameter first end section with an inner diameter less than the inner diameter of a central section of the tube. The reduced diameter first end section of the tube is bonded to a catheter shaft to form at least a portion of a skirt section of the balloon, and the skirt section has an improved high rupture pressure.

Abstract: A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by decreasing the inner diameter of a first end section of a polymeric tube, so that the tube has a reduced diameter first end section with an inner diameter less than the inner diameter of a central section of the tube. The reduced diameter first end section of the tube is bonded to a catheter shaft to form at least a portion of a skirt section of the balloon, and the skirt section has an improved high rupture pressure.

Abstract: A balloon for a catheter and a method of making the balloon, having a layer of a porous polymeric material with a modified outer surface and a lubricious coating bonded to the modified outer surface. In one embodiment, the modified outer surface is formed by a polymer impregnated in the porous polymeric material, and the subsequently applied lubricious coating bonds to the impregnating polymer. In another embodiment, the modified outer surface is formed by a functionality deposited on the porous polymeric material which bonds to the subsequently applied lubricious coating. The modified outer surface provides an improved strong bond between the lubricious coating and the balloon, for improved catheter performance.

Abstract: A catheter having a mandrel secured to the catheter or constrained within a dedicated lumen. In one embodiment, the catheter has an inner tubular member and an outer tubular member with a sidewall configured to define a mandrel lumen longitudinally along an inner surface of the outer tubular member or along an outer surface of the inner tubular member. The mandrel lumen may be configured to allow the mandrel to be exchanged to adjust the handling characteristics of the catheter. The mandrel may occupy an intermediate portion of the catheter shaft, or may extend from the proximal end to within proximal or distal shaft sections of the catheter. In coronary artery applications, the mandrel is configured to support the catheter as it bends through the aortic arch and enters the coronary artery.

Abstract: A catheter having a mandrel secured to the catheter or constrained within a dedicated lumen. In one embodiment, the catheter has an inner tubular member and an outer tubular member with a sidewall configured to define a mandrel lumen longitudinally along an inner surface of the outer tubular member or along an outer surface of the inner tubular member. The mandrel lumen may be configured to allow the mandrel to be exchanged to adjust the handling characteristics of the catheter. The mandrel may occupy an intermediate portion of the catheter shaft, or may extend from the proximal end to within proximal or distal shaft sections of the catheter. In coronary artery applications, the mandrel is configured to support the catheter as it bends through the aortic arch and enters the coronary artery.

Abstract: A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by decreasing the inner diameter of a first end section of a polymeric tube, so that the tube has a reduced diameter first end section with an inner diameter less than the inner diameter of a central section of the tube. The reduced diameter first end section of the tube is bonded to a catheter shaft to form at least a portion of a skirt section of the balloon, and the skirt section has an improved high rupture pressure.

Abstract: An improved guide catheter provides a distal tip with one or more members that assist a surgeon with locating and inserting the guide catheter through the ostium in the wall of the right atrium that leads to the coronary sinus of the heart. The guide catheter is used to implant a cardiac lead so that its electrodes are positioned in the vasculature associated with the left side of the heart.

Abstract: A catheter having an elongated shaft with a proximal shaft section and a distal shaft section, and having a support member with a proximal end within the proximal shaft section, a distal end within the distal shaft section, and at least a section which is coiled. In a presently preferred embodiment, the support member is a wire, and preferably a solid wire formed of a metal such as a stainless steel or super elastic alloy such as a nickel-titanium (Nitinol) alloy. In a presently preferred embodiment, the proximal shaft section comprises a high strength tubular member, such as a metallic tubular member. The catheter of the invention is highly pushable, flexible, trackable and kink resistant with the support member extending from the distal end of the relatively stiff proximal shaft section at the junction between the proximal and distal shaft sections.