Abstract: Thrombectomy catheters having at least one outflow orifice and one or more inflow orifices, systems including the thrombectomy catheters, and methods of using the thrombectomy catheters are described herein. The thrombectomy catheters described herein may include one or more of the protective features that may limit potential hazards to vessel walls in which the thrombectomy catheters are used.

Abstract: A catheter system includes an inflatable structural balloon and collapsible filter. The collapsible filter is deployable into an expanded configuration using the inflatable distal balloon. In the expanded configuration, one or more flow cells are formed between inflated portions of the balloon to provide continuous fluid flow between proximal and distal ends of the structural balloon. In the expanded configuration, the filter is configured to prevent particulates (e.g., dislodged thrombus, or other particulate material) from migrating beyond the filter. In the expanded configuration, the inflated structural balloon biases a perimeter of the filter toward or against a subject vessel wall.

Abstract: An infusion system includes a double action infusion pump. The pump includes a cylinder and a reciprocating piston received within the cylinder, the reciprocating piston separating a first pump chamber from a second pump chamber of the cylinder. A reciprocating motor is coupled with the reciprocating piston, and the first and second pump chambers alternate between filling and evacuating conditions with reciprocation of the reciprocating piston through operation of the reciprocating motor, and the speed of reciprocation is varied to provide a continuous output of fluid between the first and second pump chambers. A fluid source and a catheter are optionally coupled with the double action infusion pump. The catheter includes one or more infusion ports near a catheter distal portion, and the one or more infusion ports receive and expel the continuous output of fluid from the double action infusion pump.

Abstract: A thrombectomy catheter includes a catheter body extending from a catheter proximal portion to a catheter distal portion and including a catheter intermediate portion, the catheter body includes an aspiration lumen and an infusion lumen extending along the catheter body, wherein the aspiration lumen includes an aspiration orifice open at a distal end of the catheter body.

Abstract: A catheter assembly includes an inner mandrel and an outer sheath slidably coupled along the inner mandrel. The catheter assembly includes a scrubbing assembly coupled between the inner mandrel and the outer sheath. The scrubbing assembly includes a plurality of deformable struts deflectable according to movement of the inner mandrel relative to the outer sheath. The scrubbing assembly includes a proximal shoulder coupled with the outer sheath, and a distal shoulder coupled with the inner mandrel. The plurality of struts extend between the proximal and distal shoulders. The scrubbing assembly is movable between a stored configuration and a deployed configuration according to movement of the inner mandrel relative to the outer sheath. In the stored configuration the proximal and distal shoulders are remote from each other. In the deployed configuration the proximal shoulder is engaged with the distal shoulder, and the deformable struts are deflected into bristles.

Abstract: A direct stream hydrodynamic catheter system is provided for the removal of thrombus, lesions and the like including provisions for the infusion of drugs, lysing fluids and the like into a blood vessel. Physician controlled powered direct fluid jet streams emanate from a fluid jet emanatory in the form of robust radially directed fluid jet streams to impinge upon and ablate difficult and strong thrombus and lesions within a blood vessel. Effluent aspiration is controlled by an exhaust regulator in the form of a roller pump, but effluent removal can be assistingly influenced by the fluid pressure associated with the radially directed fluid jet streams.

Abstract: An infusion flow guidewire and a system including an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a nitinol hypotube, a flexible tip having a closed distal end, a coil, a core wire and at least one distally located rearwardly directed jet orifice for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided in the system for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

Abstract: A thrombectomy catheter includes a catheter body having a catheter lumen. An outflow orifice is positioned along a catheter perimeter. A fluid jet emanator communicates with a high pressure tube. The fluid jet emanator includes at least one jet orifice for directing a fluid jet from the fluid jet emanator through the catheter lumen toward the outflow orifice. The fluid jet emanator provides a jet stream from the catheter body through the outflow orifice. The jet stream includes first and second stream portions. An entrainment fluid flow circuit includes at least the first stream portion, and the entrainment fluid flow circuit entrains particulate and macerates the particulate therein. An exhaust fluid flow path includes the second stream portion, and the exhaust fluid flow path draws entrained particulate from the entrainment fluid flow circuit at a location exterior to the catheter body and directs it toward the catheter proximal portion.

Abstract: Catheters including guidewire tubes having a limited length and methods of using the catheters are described. The catheters may be delivered over guidewires in procedures that are commonly referred to as rapid-exchange delivery. In some embodiments, the catheters may be miniature flexible thrombectomy catheters that may be used to remove thrombus or other unwanted material from a body blood vessel or other small regions of body cavities in which the distal portion of the catheter has smaller external dimensions than the larger proximal portion.

Abstract: A direct stream hydrodynamic catheter system is provided for the removal of thrombus, lesions and the like including provisions for the infusion of drugs, lysing fluids and the like into a blood vessel. Physician controlled high powered direct fluid jet streams emanate from a fluid jet emanator in the form of robust radially directed fluid jet streams to impinge upon and ablate difficult and strong thrombus or lesions within a blood vessel. Effluent aspiration is controlled by an exhaust regulator in the form of a roller pump, but effluent removal can be assistingly influenced by the fluid pressure associated with the radially directed fluid jet streams.

Abstract: An atherectomy and thrombectomy system includes a catheter body extending between proximal and distal catheter portions. The catheter body includes an aspiration lumen extending therein. An atherectomy assembly is coupled with the distal catheter portion and includes a rotatable cutter. A thrombectomy assembly is coupled with the distal catheter portion. The thrombectomy assembly includes a jet body within the aspiration lumen, and inflow and outflow orifices extending through the catheter body and in communication with the aspiration lumen. In a thrombectomy configuration a cyclical flow is generated by the jet body through the outflow and inflow orifices to hydrodynamically abrade thrombus, the cyclical flow entrains thrombus and delivers thrombus into the aspiration lumen. In the atherectomy configuration the rotatable cutter cuts plaque into plaque particulate, and the cyclical flow of the thrombectomy assembly entrains the particulate and delivers the particulate into the aspiration lumen.

Abstract: An infusion flow guidewire system and method of use. The infusion flow guidewire system includes a delivery sheath and an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a flexible tip having a closed distal end, a coil, a core wire and at least one distally located jet orifice for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

Abstract: An enhanced cross stream mechanical thrombectomy catheter having a distal end with outflow and inflow orifices at one side for producing concentrated cross stream jet flow for selective and concentrated thrombus ablation during thrombectomy procedures. A multidirectional fluid jet emanator positioned within the distal catheter lumen comprises high velocity fluid jets which produce jet flow that is directed toward distal and proximal ends of the catheter. Jet flow directed toward the proximal end provides a region of low pressure near an inflow orifice which acts to pull thrombotic particulate from the vasculature. The invention provides for suitable distancing of high powered ablation or suction forces from the near walls of the vasculature. Cross stream flow emanating from one side of the catheter distal end urges the opposing non-orificed side of the catheter distal end toward and against the vascular wall to inhibit contact of the inflow orifice with the vascular wall.

Abstract: A cross stream thrombectomy catheter with a flexible and expandable cage preferably formed of nitinol for removal of hardened and aged thrombotic material stubbornly attached to the interior of a blood vessel. The cage, which can be mesh or of straight or spiral filament design, is located close to inflow and outflow orifices at the distal portion of a catheter tube and is deployed and extended at a thrombus site for intimate contact therewith and for action of a positionable assembly and subsequent rotation and lineal actuation to abrade, grate, scrape, or otherwise loosen and dislodge difficult to remove thrombus which can interact with cross stream flows to exhaust free and loosened thrombotic particulate through the catheter tube. An alternative embodiment discloses a mechanism involving a threaded tube in rotatable engagement with an internally threaded sleeve to incrementally control the deployment and expansion of the flexible and expandable cages.

Abstract: Fluid infusion systems and fluid couplings are described herein. The infusion systems may include one or more fluid couplings used to make fluidic connection between a supply line and delivery tubing. The fluid couplings separate the functions of providing a seal around a delivery tube and retaining the delivery tube within the fluid coupling. The seal provided around the delivery tube prevents leakage around an exterior surface of a delivery tube such that fluid passing through the coupling must pass through the delivery tube rather than leak around the delivery tube. The structure used to retain the delivery tube in the fluid coupling prevents ejection of the delivery tube from the coupling due to the fluid pressures present in the coupling. The separate functions are performed by different structures within the fluid couplings.

Abstract: A balloon catheter (10) having a shaft (16), a balloon (14), and an external delivery tube (12) is disclosed. Methods of using the balloon catheter having an external delivery tube are also disclosed. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly (100) is coupled with the catheter body. An agent delivery assembly (102) is coupled with the catheter body and the inflatable balloon assembly. The agent delivery assembly includes a delivery lumen (32) extending through the catheter body, and an agent delivery tube extending along an exterior balloon surface (64). The agent delivery tube includes at least one delivery orifice (70) directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: A thrombectomy catheter with a self-inflating proximal balloon having drug infusion capabilities is described. A self-inflating balloon is formed from an inflatable thin walled section of a flexible catheter tube. The self-inflating balloon includes a plurality of outflow orifices located about the peripheral circumference thereof and located proximal to an inflow gap interposed between a fluid jet emanator and the self-inflating balloon. The self-inflating balloon is inflated and expanded by internal operating pressures by proximal composite flow of fluid from the fluid jet emanator and entrained fluid from the inflow gap to uniformly space and position the outflow orifices of the self-inflating balloon in close proximity to the thrombus or vessel walls of a blood vessel. The thrombectomy catheter may be used for, among other things, thrombectomies, embolectomies, thrombus or vessel dilation, and for the delivery of drugs to a thrombus or vessel site.

Abstract: A catheter including a catheter body having a catheter lumen is disclosed. A manifold assembly is coupled with a proximal catheter portion. A manifold lumen extends through the manifold assembly and includes an assembly cavity extending around the proximal catheter portion. A fluid jet loop including fluid jet orfices along a tapered loop guide surface is coupled with a distal catheter portion. The catheter further includes a composite guide having a proximal guide insert and a distal guide. The proximal guide insert is positioned within the assembly cavity and includes a guide insert surface flush with a catheter body interior wall. The distal guide includes a tapered loop guide surface, and an intermediate guide surface of the catheter lumen is flushly engaged with a leading edge of the tapered loop guide surface, the distal guide continuously tapering inwardly and distally along the tapered loop guide surface.

Abstract: Catheters including guidewire tubes having a limited length and methods of using the catheters are described. The catheters may be delivered over guidewires in procedures that are commonly referred to as rapid-exchange delivery. In some embodiments, the catheters may be miniature flexible thrombectomy catheters that may be used to remove thrombus or other unwanted material from a body blood vessel or other small regions of body cavities in which the distal portion of the catheter has smaller external dimensions than the larger proximal portion.

Abstract: The devices of the present disclosure are rheolytic thrombectomy catheters with a self-inflating distal balloon. A self-inflating balloon is located distal to an inflow gap or orifice and distal to a fluid jet emanator, which self-inflating balloon is inflated and expanded by the utilization of internal operating forces consisting of forwardly directed high velocity fluid jet streams and/or entrained thrombus particulate therein. The self-inflating balloon, when inflated, impinges on the wall of the blood vessel to isolate sections of the blood vessel distal and proximal to the inflated balloon in order to prevent flow of thrombus particulate, fluids and the like distal to the self-inflating balloon and to provide a stagnant nonflow region proximal to the self-inflating balloon. The devices of the present disclosure also provide for a uniform spacing of the catheter tube with respect to the thrombus and/or wall of the blood vessel.