Abstract: An enhanced cross stream mechanical thrombectomy catheter with backloading manifold 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. 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 the one side of the distal end of the catheter resultantly urges the distal end of the catheter and thus the opposing non-orificed side of the distal end of the catheter toward and against the vascular wall to inhibit contact of the inflow orifice with the vascular wall. Features of the invention include a geometrically configured insert to facilitate the backloading or exchange of guidewires.

Abstract: The present invention pertains to a miniature flexible thrombectomy catheter having one or more flexible miniature noncollapsing tubular portions including pushable and torqueable structure for introduction into the smaller vessels in neurovascular regions. A jet body having an arcuate fluid jet emanator is incorporated in order to minimize size at the distal portion of a minimally sized catheter tube.

Abstract: A storable gas inflation/evacuation system and sealing system. The systems are removably connectible to a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion. The invention includes provision for indicating the presence of oxygen which is undesirable. The storable aspect concerns a sealable container isolating systems components from ambient atmosphere and an oxygen-sensitive material located within the sealable container. The oxygen-sensitive material is initially inactive but activated by exposure to radiation so as to visually change in response to post-radiation oxygen exposure.

Abstract: A thrombectomy catheter device having an improved hemostasis valve which is self-sealing and which functions as a one-way valve. The self-sealing hemostasis valve can be factory preset to automatically seal with or without the inclusion of a guidewire at a certain desired pressure or allowable leakage. Such sealing is automatic without the need to manually manipulate a hemostasis nut to obtain hemostasis. The thrombectomy catheter device can, without hemostasis nut adjustment, be positioned along and about a guidewire while yet maintaining suitable pressure for sustaining hemostasis at a preferred level. Certain embodiments of the thrombectomy catheter device having a self-sealing hemostasis valve include an adjustable hemostasis nut which can be manually tightened to restrict flow or guidewire movement or loosened to reduce friction on the guidewire and allow fluid to flow out if desired.

Abstract: A gas inflation/evacuation system and sealing system for use with occlusive devices in vascular procedures. The gas inflation/evacuation system is removably connectable via the sealing system to a proximal portion of a guidewire assembly having a guidewire that defines a lumen and includes a first syringe system for evacuating the lumen and a second syringe system for introducing a biocompatible gas into the lumen to inflate an occlusive balloon that is in fluid communication with the lumen a plurality of times. The sealing system selectively seals the proximal portion of the guidewire and includes a crimping mechanism and a compression sealing mechanism having a resilient seal for sealing around the proximal portion of the guidewire when it is passed therethrough.

Abstract: A packaging system or storage arrangement that includes provision to indicate the presence of oxygen. An oxygen-sensitive material is placed inside a sealable container. Air is evacuated from the sealable container and the sealable container is sealed to isolate the oxygen-sensitive material from oxygen. The sealable container is then irradiated with an effective amount of radiation to activate the oxygen-sensitive material such that the oxygen-sensitive material will undergo a visual change in the presence of oxygen after the oxygen-sensitive material has been irradiated. The visual change provides an indication of the presence of oxygen inside the sealable container.

Abstract: A thrombectomy catheter system with occluder and method of using same for removal of tissue, such as thrombus and the like, from a vessel in the body. Multiple catheters and an occluder-bearing guidewire tube at a thrombus site provide for expandable deployment of a compliant occluder against the vasculature walls distal to the thrombus. The expanded occluder is maneuvered proximally to urge thrombus into close proximity with a retractable capture cone located distally on a capture catheter where the thrombus is dislodged, entrained, and broken into pieces by the action of a fluid jet emanator and then evacuated through the capture catheter.

Abstract: A tubular guidewire assembly having a distal occlusive device and an extended crimpable section proximate a proximal end that is adapted to connect to a gas inflation/evacuation system. The extended crimpable section can be selectively sealed at one of a plurality of separate locations to form an airtight seal of the tubular guidewire assembly. Each time a deflation of the occlusive device is desired in order to reestablish blood flow to a vessel downstream of the occlusive device, the extended crimpable section preferably is cut distal to the location of the last seal to quickly deflate the occlusive device.

Abstract: A device for removing a thrombus or other tissue deposit from the cardiovascular system, natural or synthetic tubule or cavity found in the human body of a patient without the need to surgically access the location of the thrombus or other tissue deposit via a cut-down or other surgical procedure. A flexible metal or high pressure plastic tube conveys an extremely high pressure stream of sterile saline or other physiologic solution to at least one jet at the distal end of the catheter. At least one jet is directed at the opening of a large exhaust lumen or other target. The jet(s) is responsible for providing a localized negative pressure which entrains tissue into the jet from break-up of the debris. This jet(s) can also provide stagnation pressure in the exhaust lumen which drives the tissue or thrombotic debris out of the exhaust lumen. Operation of the device with tip pressure greater than 500 psi provides this device with the entrainment and exhaust characteristics which contribute to its effectiveness.

Abstract: Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

Abstract: A gas inflation/evacuation system and sealing system for use with occlusive devices such as occlusive balloons in vascular procedures. The gas inflation/evacuation system is removably connectible to a proximal portion of a guidewire assembly and includes an evacuation system to evacuate the guidewire assembly and an inflation system for introducing a biocompatible gas under pressure into the guidewire assembly to inflate an occlusive device a plurality of times. A sealing system is also removably connectible to the proximal portion of the guidewire assembly and selectively seals an extended sealable section at the proximal portion of the guidewire assembly at one of a plurality of separate locations to form an airtight seal of the guidewire assembly.

Abstract: A guidewire occlusion system for use in vascular procedures includes a repeatably inflatable gas-filled occlusive device proximate a distal end of a tubular guidewire assembly having an extended sealable section proximate a proximal end. A gas inflation/evacuation system is removably connectable to the proximal end of the guidewire assembly and includes an evacuation system to evacuate air from the guidewire and an inflation system for introducing a gas under pressure into the guidewire to inflate the occlusive balloon a plurality of times. A sealing system is also removably connectable to the proximal end of the guidewire assembly and selectively seals the extended sealable section at one of a plurality of separate locations along the extended sealable section to form an airtight seal of the tubular guidewire.

Abstract: A method for removing thrombus or other material from a natural or synthetic body vessel or cavity without the need for direct surgical access. The method includes providing a device supplying high pressure fluid to at least one distal orifice, causing high pressure fluid to emanate from the orifice creating at least one fluid jet, and using the fluid jet to break up material in the vessel. The method further includes directing at least one fluid jet at the opening of an exhaust lumen or target incorporated into the device and using the jet to provide a localized negative pressure which entrains material into the jet for break-up. The method optionally includes using the jet to provide stagnation pressure which drives material along the exhaust lumen. The method optionally includes metering the exhaust to match the fluid input or to be greater or less than the input. A positive displacement pump operating at steady or pulsatile flow provides the high pressure saline to the distal end of the catheter.

Abstract: A rapid exchange fluid jet thrombectomy device for removal of thrombus or unwanted tissue debris from a vein, artery or the like. The device includes a semi-rigid intermediate tube between a proximal and a distal exhaust tube which accommodates a guidewire tube exit located along the catheter at less than one-half the length of the catheter measured from the catheter most distal point. Such a location of the guidewire is convenient for maneuvering and longitudinal advancement of the guidewire, as well as maneuvering and longitudinal advancement of the catheter by one practitioner.

Abstract: Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

Abstract: Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

Abstract: A single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. Embodiments include an outer catheter assembly common to any mode of usage having a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a flow director are passed and advanced. For use as a rheolytic thrombectomy catheter, thrombus is dislodged, entrained, and broken into pieces by jets and evacuated through the lumen of the guide catheter. For use as a crossflow thrombectomy catheter, a flow director having outflow and inflow orifices is provided.

Abstract: Cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

Abstract: A device for removing a thrombus or other tissue deposit from the cardiovascular system, or from a natural or synthetic tubule or other cavity found in the human body of a patient without the need to surgically access the location of the thrombus or other tissue deposit via a cut-down or other surgical procedure. A flexible metal or high pressure plastic tube conveys an extremely high pressure stream of sterile saline or other physiologic solution to at least one orifice at the distal end of the catheter. At least one jet is directed at the opening of a large exhaust lumen or other target. The jet is responsible for providing a localized negative pressure which entrains tissue into the jet from break-up of the debris. This jet can also provide stagnation pressure in the exhaust lumen which drives the tissue or thrombotic debris out of the exhaust lumen.

Abstract: A single operator exchange fluid jet thrombectomy method employing a single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. The outer catheter assembly is common to any mode of usage and includes a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a jet emanator and a flow director are passed and advanced. In the method, thrombus is dislodged, entrained, and broken into pieces by fluid jets and evacuated through the lumen of the guide catheter.