Abstract: Assemblies and methods for scoring a stenotic region within a vessel of a patient are disclosed. An assembly can comprise a scoring member and a deployment member. The scoring member can include an elongate push structure and a tubular, self-expanding scaffold. The elongate push structure can be positioned proximal of the self-expanding scaffold and, at its distal end portion, eccentrically coupled with a proximal end portion of the self-expanding scaffold. The deployment member can be removably positioned within a central lumen of the self-expanding scaffold and detachably engageable with a portion of the self-expanding scaffold. The self-expanding scaffold can be movable between a downsized configuration, when receiving axial tension from the deployment member, and an expanded configuration, in the absence of axial tension.

Abstract: Guidewires and related methods for percutaneous crossing of an occlusion in a blood vessel are disclosed. A guidewire can include a core member and a jacket member. The core member can extend from a proximal end portion to a distal end portion, with the distal end portion including a first segment, a more distal second segment and a more proximal third segment. The first segment can be configured to encourage prolapse by way of a short taper or a diameter-reduced portion. The jacket member can surround at least the distal end portion of the core member. A method can include advancing a distal end portion of the guidewire through the natural lumen of a blood vessel to a location near an occlusion. A longitudinal pushing force can be applied to a proximal end portion of the guidewire, thereby causing a first segment of the distal end portion to prolapse.

Abstract: This patent document discloses assemblies and methods for removing obstructive material from a body vessel or other cavity. An assembly can include an elongate inner member, an elongate outer member, an aspirator, one or more valves, or a waste collection reservoir. Each of the elongate members can extend from a proximal end portion to a distal end portion and can include a lumen therethrough. The elongate inner member can be partially disposed in the lumen of the elongate outer member and can be moveable along its longitudinal axis relative to the elongate outer member. The aspirator can be in flow communication with the proximal end portion of the elongate inner member for drawing the obstructive material into or through its lumen. The one or more valves can be configured and positioned to allow obstructive material removed from the body vessel or cavity to be urged toward the waste collection reservoir.

Abstract: Catheter devices, assemblies and related methods for percutaneous crossing of an occlusion in a blood vessel are disclosed. A catheter device can include a central catheter, two side tubes, and a distally-protruding, curved subintimal guidewire. The central catheter can define a central lumen that extends from a proximal end to a distal end of the central catheter. The lumen can be configured to receive a primary guidewire. The central catheter can also define at least one reentry aperture oriented transverse to the central lumen. The first and second side tubes can be coupled with the central catheter, extending along a longitudinal axis thereof, with the first side tube flanking an opposite side of the central catheter relative to the second side tube. The subintimal guidewire can extend from the first side tube, distally beyond the distal end of the central catheter, to the second side tube.

Abstract: This patent document discloses methods for facilitating revascularization of an occlusion in a blood vessel. A method can include engaging a first guide within a vessel wall adjacent to a distal cap of the occlusion and advancing the first guide, in a retrograde direction, to a subintimal position near a proximal cap of the occlusion. A second guide can be engaged within the proximal cap or the vessel wall adjacent to the proximal cap and advanced, in an antegrade direction, until its distal end is near or axially overlaps a distal end of the first guide. A first vessel lumen, formed by advancement of the first guide, and a second vessel lumen, formed by advancement of the second guide, can be connected by inflating a balloon positioned at or near the distal end of the second guide.

Abstract: Catheters and methods for supporting a guidewire or delivering a radiopaque, diagnostic or therapeutic agent through a vessel stenosis or other tortuous anatomy are disclosed. A catheter can comprise an elongate shaft body and a tip member disposed at a distal end of the shaft body. The shaft body can extend from a proximal end to the distal end and can define an inner lumen. The shaft body can include a liner, a braid member surrounding the liner, a multi-layer coil surrounding the braid member, and a polymer cover surrounding the multi-layer coil. An outer surface portion of the polymer cover can include one or more helical threads, which can be enveloped in an outer wrapper. The tip member can be made from a metal or a polymer. Polymer tip members can include a hard or semi-hard distal tip.

Abstract: This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include a balloon formed of an inflatable tube and an elongate shaft having a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon. The inflatable tube can be coiled in a helical manner around a central axis into a series of windings. Adjacent windings can be stacked against and bonded to each other, and an inner surface of the series of windings, when inflated, can define the passage. The elongate shaft can be eccentrically attached to a proximal portion of the balloon and the shaft's lumen can be in fluid communication with the interior of the balloon, specifically the inflatable tube. The inflatable tube can include two different polymer tubes, one slightly smaller than the other.

Abstract: Embolic materials, suspensions, kits and related methods useful for embolization are disclosed. An embolic material can comprise a resorbable microsphere including cross-linked gelatin as its primary ingredient and having a substantially spherical shape with a diameter of about 50 micrometers to about 1,500 micrometers, inclusive. The microsphere can optionally include one or both of a marker or an active agent. The microsphere can be cross-linked, such as with glutaraldehyde or formaldehyde, which can affect the microsphere's in vivo degradation profile and ability to withstand a sterilization process at certain temperatures. In an embodiment, the microspheres can resorb during an in vivo time period of between about 24 hours and about 15 weeks, inclusive. An embolization suspension can include a plurality of resorbable microspheres and a liquid carrier, and the suspension can be disposed in a syringe, vial or other applicator for administration to a patient.

Abstract: Guidewires and methods for transmitting electrical stimuli to a heart and for guiding and supporting the delivery of elongate treatment devices within the heart are disclosed. A guidewire can comprise an elongate body, including first and second elongate conductors, and at least first and second electrodes. A distal end portion of the elongate body can include a preformed bias shape, such as a pigtail-shaped region, on which the first and second electrodes can be located. The preformed bias shape can optionally be non-coplanar relative to an intermediate portion of the elongate body. The first and second elongate conductors can be formed of a single structure or two or more electrically connected structures. The conductors can extend from proximal end portions to distal end portions that electrically connect to the first and second electrodes.

Abstract: This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include a balloon formed of an inflatable tube and an elongate shaft having a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon. The inflatable tube can be coiled in a helical manner around a central axis into a series of windings. Adjacent windings can be stacked against and bonded to each other, and an inner surface of the series of windings, when inflated, can define the passage. The elongate shaft can be eccentrically attached to a proximal portion of the balloon and the shaft's lumen can be in fluid communication with the interior of the balloon, specifically the inflatable tube. The inflatable tube can include two different polymer tubes, one slightly smaller than the other.

Abstract: Embolic materials, suspensions, kits and related methods useful for embolization are disclosed. An embolic material can comprise a resorbable microsphere including cross-linked gelatin as its primary ingredient and having a substantially spherical shape with a diameter of about 50 micrometers to about 1,500 micrometers, inclusive. The microsphere can optionally include one or both of a marker or an active agent. The microsphere can be cross-linked, such as with glutaraldehyde or formaldehyde, which can affect the microsphere's in vivo degradation profile and ability to withstand a sterilization process at certain temperatures. In an embodiment, the microspheres can resorb during an in vivo time period of between about 24 hours and about 15 weeks, inclusive. An embolization suspension can include a plurality of resorbable microspheres and a liquid carrier, and the suspension can be disposed in a syringe, vial or other applicator for administration to a patient.

Abstract: A catheter cutting device can include a base, first and second support blocks coupled to the base, first and second roller shafts extending between and movably coupled to the first and second support blocks, and a sliding plate movably engaged with at least one of the support blocks or roller shafts such that movement of the sliding plate causes one or both of the first and second roller shafts to rotate. An arm including a cutting blade can extend in a direction perpendicular to the extension of the first and second roller shafts and can be coupled to the base or the sliding plate.

Abstract: Closure systems, kits and methods for sealing a percutaneous puncture or other opening in a blood vessel wall, body cavity or biopsy tract are disclosed. A closure system can comprise an implant assembly, a delivery assembly, and an introducer sheath. The closure system can further comprise a valve bypass and a dilator. The implant assembly can include an inner member, a sealing membrane, and an outer member, each of which can be delivered by the delivery assembly. The inner member can be extended through the puncture or opening and positioned adjacent an inner tissue surface. The outer member can be positioned adjacent an outer tissue surface. The sealing membrane can have a distal end attached to the inner member, a proximal end including an opening configured to receive the outer member, and a mid-region therebetween.

Abstract: This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include a balloon formed of an inflatable tube and an elongate shaft having a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon. The inflatable tube can be coiled in a helical manner around a central axis into a series of windings. Adjacent windings can be stacked against and bonded to each other, and an inner surface of the series of windings, when inflated, can define the passage. The elongate shaft can be eccentrically attached to a proximal portion of the balloon and the shaft's lumen can be in fluid communication with the interior of the balloon, specifically the inflatable tube. The inflatable tube can include two different polymer tubes, one slightly smaller than the other.

Abstract: Assemblies and methods for delivering an implant to a patient are disclosed. A delivery assembly can comprise an elongate tube, an outer magnetic member, and an inner magnetic member. The elongate tube extends from a proximal end portion to a distal end portion and defines a delivery lumen. The outer magnetic member can be movable along an outer surface of the tube; the inner magnetic member can be positioned within the delivery lumen and magnetically coupled to the outer magnetic member through a sidewall of the tube. The inner magnetic member can be movable through the delivery lumen when actuated by relative movement between the outer magnetic member and the tube. The delivery assembly can further comprise a syringe or an inflator/deflator couplable to a hub at the proximal end portion of the tube. The syringe or inflator/deflator can be used to urge fluid against a proximal end portion of the inner magnetic member.