Abstract: Sheath assemblies incorporating slotted structures at one or more areas provide areas of different flexibility and bendability characteristics along the length of the sheath assembly. An inner tubular member has an arrangement of discontinuous slots along at least a portion of its length, with at least some of the slots terminating in an enlarged aperture at at least one terminus of the slot, and a flexible outer tubular member contacts and extends over at least a portion of the inner tubular member.

Abstract: A multi-station hydrodynamic catheter includes an outer catheter having a first lumen, the outer catheter having a plurality of orifice stations positioned along a portion of the outer catheter, where each orifice station includes one or more orifices extending from an outer catheter external surface to the first lumen. The multi-station hydrodynamic catheter includes an inner catheter having a second lumen, the inner catheter movable within the first lumen and includes at least one emanator, where the at least one emanator includes one or more fluid delivery ports extending from an inner catheter external surface to the second lumen.

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 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: Peristaltic pump assemblies in which the closing and opening of a pivoting or sliding door is coordinated with movement of the occlusion bed toward and away from the rotor assembly to engage and disengage tubing within the occlusion pathway are disclosed. Linkage mechanisms provided by the interaction of cam surfaces with rollers, as well as bar linkage mechanisms, are disclosed. The linkage mechanism, in addition to providing precise displacement of the occlusion bed, may also provide an over-center feature that enhances safety and pump operation when the door is in a closed position. Latching mechanisms and sensors may be incorporated. Control consoles incorporating such peristaltic pump assemblies are described. Adaptive components such as tubing cassettes routing aspiration and/or infusion tubing in a predetermined configuration to mate with occlusion pathways in aspiration and/or infusion pump assemblies provided in various types of medical devices and control consoles are also provided.

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: An interventional catheter assembly has an operating head and catheter system that are inserted and navigated within a patient's body while an operator controls the system externally of the operating head. An operating head is positioned at or near a distal end of the catheter system and coupled to a drive shaft and drive system for rotation. A guidewire brake control system interrupt prevents the drive system from being actuated when the guidewire brake is in a released position, and a selectable guidewire brake interrupt override control permits an operator to translate and/or rotate the drive shaft and operating head while the guidewire is simultaneously moved. This allows withdrawal of the guide wire and the operating head from the target site while rotating the operating head.

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 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 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: An interventional catheter assembly has an operating head and catheter system that are inserted and navigated within a patient's body while an operator controls the system externally of the operating head. An operating head is positioned at or near a distal end of the catheter system and coupled to a drive shaft and drive system for rotation. A guidewire brake control system interrupt prevents the drive system from being actuated when the guidewire brake is in a released position, and a selectable guidewire brake interrupt override control permits an operator to translate and/or rotate the drive shaft and operating head while the guidewire is simultaneously moved. This allows withdrawal of the guide wire and the operating head from the target site while rotating the operating head.

Abstract: A rotatable operating head for removal of obstructive material from a target site in a body lumen or cavity is operably connected to a rotatable, translatable drive shaft, that is driven by a drive motor and received through an elongated catheter. The operating head includes a plurality of differential cutting blades, with at least one of the cutting blades being a stepped blade, the stepped blade comprising a raised cutting surface positioned adjacent, or in proximity to, a shoulder region.

Abstract: Segmented articulatable stent of open structure comprised of end-connected struts of first and second lengths making up first and second segments with angular interconnects between adjacent first and second segments.

Abstract: A device, such as for use with lumen reentry, including a catheter including a balloon disposed at a distal end thereof, the catheter being formed with a first lumen through the balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of the balloon, the catheter and the balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein upon expansion of the balloon when placed between the layers, a distal portion of the first lumen that passes through the balloon is bent with respect to a portion of the first lumen proximal to the balloon and is directed towards the body lumen.

Abstract: A device, such as for use with lumen reentry, including a catheter including a balloon disposed at a distal end thereof, the catheter being formed with a first lumen through the balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of the balloon, the catheter and the balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein upon expansion of the balloon when placed between the layers, a distal portion of the first lumen that passes through the balloon is bent with respect to a portion of the first lumen proximal to the balloon and is directed towards the body lumen.

Abstract: A device, such as for use with lumen reentry, including a catheter including a balloon disposed at a distal end thereof, the catheter being formed with a first lumen through the balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of the balloon, the catheter and the balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein upon expansion of the balloon when placed between the layers, a distal portion of the first lumen that passes through the balloon is bent with respect to a portion of the first lumen proximal to the balloon and is directed towards the body lumen.

Abstract: A method including introducing a catheter between two layers of a wall of a body lumen, the catheter including a balloon disposed at a distal end thereof, the catheter being formed with a first lumen through the balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of the balloon, and expanding the balloon so that a distal portion of the first lumen that passes through the balloon is bent with respect to a portion of the first lumen proximal to the balloon and is directed towards the body lumen.