Abstract: The general purpose of the present invention is to provide a catheter for removal of an organized embolic thrombus, preferably in conjunction with a distal occlusion balloon guidewire. The present invention consists of three main components including a capture/delivery sheath, a capture sleeve of mesh attached to a tube and a grasping mechanism attached to another tube which is central to the other components. Operative structures in the form of manifolds are connected to such components in order to manipulate and control the relative positions of the capture/delivery sheath, the capture sleeve and the grasping mechanism. An embolic thrombus is engaged by the deployable automatically expanding serrated fingers of a grasping mechanism in combination with a deployable automatically expanding mesh capture sleeve. The capture/delivery sheath is maneuvered to cause compression of the serrated fingers and of the mesh capture sleeve for subsequent removal of the embolic thrombus.

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: Medical devices and methods for making and using medical devices are disclosed. An example catheter is disclosed. The catheter comprises a catheter body having a catheter lumen and a high pressure tube disposed within the catheter lumen. The high pressure tube has a substantially circular cross section. The catheter also includes a fluid jet loop coupled to the high pressure tube at a transition section. The transition section has a circular cross section and a non-circular cross section. The fluid jet loop includes fluid jet orifices along a tapered loop guide surface. The catheter also includes a distal guide. The intermediate guide surface of the catheter lumen flushly engages with a leading edge of the tapered loop guide surface and the distal guide is configured to guide the instrument over the intermediate guide surface, the tapered loop guide surface and through the fluid jet loop.

Abstract: The present invention provides a forwardly directed fluid jet crossing catheter having a distally directed cylindrical flow fluid jet stream to cross a chronic total occlusion. The distal end of the device includes a formable catheter tip region having flexible internal components. Low and high pressure cavities are formed substantially by joined proximal and distal catheter tubes having an adhesive plug seal in common therebetween which partially defines one end of each of the low pressure and high pressure cavities. A guidewire tube and a high pressure tube are aligned along and within the low pressure and high pressure cavities and through the adhesive plug seal. The high pressure tube openly terminates in the high pressure cavity, whereby pressurized fluid transfers from the high pressure cavity in the guidewire tube entry hole to subsequently pass along the guidewire lumen and co-located guidewire to exit as a cylindrical fluid jet stream.

Abstract: A catheter including at least one distal opening positioned at or near the distal end and at least one proximal opening near the proximal end and proximal to the at least one distal opening is described. The catheter may be configured for delivering at least a first fluid through the at least one distal opening to a central circulation system of a patient and delivering at least a second fluid through the at least one proximal opening to a peripheral circulation system of the patient.

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: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluid in the manifold presses on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to the pressure of the pressurized fluid. In the open configuration, the pressure actuated seal element relaxes in the absence of the pressurized fluid, and the seal element lumen is open and configured to allow passage of an instrument.

Abstract: A balloon catheter having a shaft, a balloon, and an external delivery tube, as well as methods of use thereof. 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 is coupled with the catheter body. An agent delivery assembly, which is coupled with the catheter body and the inflatable balloon assembly, includes a delivery lumen extending through the catheter body and an agent delivery tube extending along an exterior balloon surface. The agent delivery tube includes at least one delivery orifice 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 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: A forwardly directed fluid jet crossing catheter having a distally directed cylindrical flow fluid jet stream to cross a chronic total occlusion is set forth. The distal end of the device includes a formable catheter tip region having flexible internal components. Low and high pressure cavities are formed substantially by joined proximal and distal catheter tubes having an adhesive plug seal in common therebetween which partially defines one end of each of the low pressure and high pressure cavities. A guidewire tube and a high pressure tube are aligned along and within the low pressure and high pressure cavities and through the adhesive plug seal. The high pressure tube openly terminates in the high pressure cavity, whereby pressurized fluid transfers from the high pressure cavity in the guidewire tube entry hole to subsequently pass along the guidewire lumen and co-located guidewire to exit as a cylindrical fluid jet stream.

Abstract: A device for inserting a catheter into a blood vessel that uses fluid flow to aid the insertion of the catheter into a patient is described herein. The device includes a catheter retention device that houses a catheter and is configured to attach to an angiocatheter or other blood vessel access device. The catheter retention device receives fluid and guides the catheter into the blood vessel using the flow of fluid to carry the catheter into the blood vessel.

Abstract: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and a catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluids in the manifold press on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to a pressure of the pressurized fluids. In the open configuration, the pressure actuated seal element relaxes in an absence of the pressurized fluids, and the seal element lumen is open and configured to allow passage of an instrument.

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 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.