Abstract: Balloon angioplasty catheters having cutting or scoring members that are moveable in at least one direction between a stowed position (away from the angioplasty balloon) and an operative position (on the angioplasty balloon). A balloon catheter of the present invention alternately useable to perform balloon dilation of a body lumen with and without concurrent cutting or scoring.

Abstract: An occlusion bypassing apparatus is disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, an inner shaft component disposed within the outer shaft component, and a needle component slidably disposed within the inner shaft component. The inner shaft component includes a body portion and a needle housing, which is distal to the body portion. The needle housing is less flexible than the body portion. In order to smooth the transition between the body portion and the needle housing, the needle housing includes a transition portion that has a variable flexibility along its length that decreases in a distal direction. A curved distal end of the needle component is distally advanced relative to the inner shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.

Abstract: A catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO).

Abstract: Catheter assemblies include a stabilization mechanism disposed at a distal end of the catheter assembly for stabilizing the catheter assembly within a subintimal space. The stabilization mechanism includes a self-expanding support structure that is slidably positionable within an inflatable balloon. The catheter assemblies include an outer shaft which has the balloon at a distal end thereof and an inner shaft which has the support structure mounted on a distal end thereof. The inner shaft is slidably disposed within a lumen of the outer shaft and has a first configuration in which the support structure is held in a compressed state within the outer shaft and a second configuration in which the support structure is permitted to return to an expanded state within the inflatable balloon. In the expanded state, the stabilization mechanism has a flattened laterally-extending profile.

Abstract: A catheter for use with a subintimal reentry guidewire includes a proximal portion having a proximal guidewire lumen and a proximal inflation lumen, a distal portion having a distal guidewire lumen and a distal inflation lumen, and an intermediate portion disposed between the proximal portion and the distal portion and having an intermediate inflation lumen in fluid communication with the proximal and distal inflation lumens. The intermediate portion is devoid of a guidewire lumen. A blocking mechanism disposed in the distal portion of the catheter is transformable from a non-blocking configuration in which a guidewire is free to translate through the distal guidewire lumen and a blocking configuration in which a guidewire disposed in the distal guidewire lumen is prevented from translating through the distal guidewire lumen.

Abstract: Catheter devices and methods useable for directing a guidewire from a subintimal position within the wall of an artery into the true lumen of that artery or other applications wherein it is desired to direct a guidewire or other elongate device from one location to another location within a subject's body.

Abstract: A balloon catheter, in particular a balloon catheter for angioplasty, the balloon having an inner or outer surface modified by means of a photoactivation reaction.

Abstract: Balloon angioplasty catheters having cutting or scoring members that are moveable in at least one direction between a stowed position (away from the angioplasty balloon) and an operative position (on the angioplasty balloon). A balloon catheter of the present invention alternately useable to perform balloon dilation of a body lumen with and without concurrent cutting or scoring.

Abstract: A balloon (1) for treating stenosis and the method for obtaining this balloon. The method comprises the steps of: bringing the balloon in the deployed configuration; placing a plurality of stylets (17) that are arranged in the axial direction along the outer wall (10) of the balloon, pushing the stylets towards the balloon core (11) in the radial direction such as to form a plurality of laps (12); laying the laps about the core in the tangential direction such as to lay each lap on an adjacent stylet; removing the stylets such as to form a plurality of cavities (13) comprised between each lap and the balloon core; filling the cavities with the drug.

Abstract: A coated medical balloon that includes a polymeric material having a surface with a therapeutic agent-containing mixture coated thereon, wherein the mixture includes a therapeutic agent, an unsaturated carboxylic acid, and a salt of the unsaturated carboxylic acid.

Abstract: A balloon catheter, in particular a balloon catheter for angioplasty, the balloon having an inner or outer surface modified by means of a photoactivation reaction.

Abstract: Catheter assemblies include a stabilization mechanism disposed at a distal end of the catheter assembly for stabilizing the catheter assembly within a subintimal space. The stabilization mechanism includes a self-expanding support structure that is slidably positionable within an inflatable balloon. The catheter assemblies include an outer shaft which has the balloon at a distal end thereof and an inner shaft which has the support structure mounted on a distal end thereof. The inner shaft is slidably disposed within a lumen of the outer shaft and has a first configuration in which the support structure is held in a compressed state within the outer shaft and a second configuration in which the support structure is permitted to return to an expanded state within the inflatable balloon. In the expanded state, the stabilization mechanism has a flattened laterally-extending profile.

Abstract: A catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO).

Abstract: A catheter for subintimally bypassing an occlusion in a vessel includes a catheter shaft including a guidewire lumen disposed therethrough and having a shaft longitudinal axis, at least two balloons coupled to an exterior of the catheter shaft such that longitudinal axes of the balloons are in a common plane with the shaft longitudinal axis when uninflated and with no external forces on the catheter. The balloons are configured such that when the catheter is disposed in the subintima of a vessel and the balloons are inflated, a tip of the catheter shaft is oriented towards a true lumen of the vessel distal of the occlusion.

Abstract: A catheter for use with a subintimal reentry guidewire includes a proximal portion having a proximal guidewire lumen and a proximal inflation lumen, a distal portion having a distal guidewire lumen and a distal inflation lumen, and an intermediate portion disposed between the proximal portion and the distal portion and having an intermediate inflation lumen in fluid communication with the proximal and distal inflation lumens. The intermediate portion is devoid of a guidewire lumen. A blocking mechanism disposed in the distal portion of the catheter is transformable from a non-blocking configuration in which a guidewire is free to translate through the distal guidewire lumen and a blocking configuration in which a guidewire disposed in the distal guidewire lumen is prevented from translating through the distal guidewire lumen.

Abstract: Occlusion bypassing apparatuses are disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The occlusion bypassing apparatuses include a shaft component and a needle component slidably disposed within the shaft component and having an angled configuration when deployed. In embodiments hereof, the needle component has an angled distal tip segment that may be utilized to selectively bend a flexible distal portion of the shaft component in order to extend the flexible distal portion towards the true lumen of the vessel. The needle component is distally advanced relative to the shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.

Abstract: Occlusion bypassing apparatuses are disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The occlusion bypassing apparatuses include a shaft component and a needle component slidably disposed within the shaft component and having an angled configuration when deployed. In embodiments hereof, the needle component has an angled distal tip segment that may be utilized to selectively bend a flexible distal portion of the shaft component in order to extend the flexible distal portion towards the true lumen of the vessel. The needle component is distally advanced relative to the shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.

Abstract: Catheter devices and methods useable for directing a guidewire from a subintimal position within the wall of an artery into the true lumen of that artery or other applications wherein it is desired to direct a guidewire or other elongate device from one location to another location within a subject's body.

Abstract: True lumen reentry devices and methods useable for redirecting a guidewire from a subintimal tract within a wall of a blood vessel into the true lumen of the blood vessel. A reentry catheter device comprises a main catheter shaft having at least one guidewire outlet aperture with at least one side tube located on a distal portion of the main catheter shaft. The side tube(s) is/are tracked over initially inserted guidewire(s) to advance a distal portion of the reentry catheter device into the subintimal tract with a guidewire.

Abstract: This invention concerns a guide catheter comprising a hollow tubular body extending along a main longitudinal axis, said tubular body defining at ] least one internal lumen suitable for receiving at least one medical device, the tubular body further defining at least one proximal opening and one distal opening. The tubular body includes a distal portion preformed in such a way as to take on a curved configuration with regard to the main axis. At least the distal portion of the tubular body has a flattened shape that extends prevalently along a main transversal axis, the curvature of said distal portion being created around said main transversal axis.