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: Filtration devices for collection and filtration of biological samples are disclosed. Devices having a filtration element oriented in a generally vertical orientation are provided, as well as filtration devices that incorporate a cooling mechanism to reduce the temperature of collected solids. Tissue collection devices, such as aspiration assemblies, tissue sampling devices, and the like incorporating filtration devices are disclosed. Methods of collecting biological samples and separating biological solids from a liquid/solids mixture are also disclosed, together with analytical techniques and protocols for analyzing biological samples.

Abstract: An interventional catheter assembly comprises an operating head for removing obstructive material from a target site in a body lumen or cavity and at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the aspiration port being in communication with a sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site. The interventional catheter incorporates an elongated guidewire lumen bushing extending proximally from a distal region of the operating head to reduce the clearance between the guidewire and the internal surface of the guidewire lumen during operation of the interventional catheter. This feature restricts entry of fluid and debris into the guidewire lumen and promotes maintenance of consistent and high aspiration pressure and volume during operation of the aspiration system and interventional catheter assembly.

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. Fluidic communication is provided between the operating head and the external system controls, and rotation is provided to the operating head by means of an external drive system. Numerous system controls are provided, along with various operating systems, sealing assemblies, actuators, torque transfer systems, and the like are provided. Some systems and controls are provided in a control pod and some controls, as well as displays, are provided in a console unit. Control pod, catheter system and operating head may be provided as a sterile, single use interventional catheter system, while the console unit may be provided as a multiple use device that communicates with the sterile, single use interventional catheter system during operation.

Abstract: Interventional catheter assemblies, operating systems and adaptive interface components allow operation of a variety of interventional catheter assemblies, including infusion catheters, aspiration catheters and interventional catheters that provide both infusion and aspiration, using a common control console housing infusion and aspiration systems. Control instructions for operating the interventional catheter assembly and authentication protocols for verifying system matches and operating conditions maybe encoded in hardware, firmware or software, such as a memory or storage device, provided in the interventional catheter assembly or in a discrete adaptive interface component. Adaptive components such as tubing cassettes routing aspiration and/or infusion tubing in a predetermined configuration to mate with aspiration and infusion systems on a control console are also provided.

Abstract: An interventional catheter assembly comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Abstract: Interventional catheter assemblies that operate over a guide wire and incorporate guide wire management systems are disclosed. Specifically, a guide wire buffer zone is provided between a proximal end of the interventional catheter and the guide wire clamp that accommodates variable lengths of exposed guide wire in an unrestrained condition when the guide wire is clamped, allowing the distal end of the operating catheter to be advanced and retracted over the distal end of the guide wire without repositioning and reclamping the proximal end of the guide wire. The configuration of the guide wire buffer zone may be adjusted prior to or during an intervention based on the anticipated range of axial motion of the catheter and operating head relative to the guide wire.

Abstract: Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a therapeutic composition, or tissue penetration members for scoring or disrupting tissue prior to or during administration of a therapeutic composition are provided. Infusion of therapeutic composition(s) may also be provided.

Abstract: An interventional catheter assembly comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Abstract: An interventional catheter assembly has an operating head [400] and catheter system [300] that are inserted and navigated within a patient's body while an operator controls the system externally of the operating head. Fluidic communication is provided between the operating head and the external system controls, and rotation is provided to the operating head by means of an external drive system. Numerous system controls are provided, along with various operating systems, sealing assemblies, actuators, torque transfer systems, and the like are provided. Some systems and controls are provided in a control pod [200] and some controls, as well as displays, are provided in a console unit [100]. Control pod [200], catheter system [300] and operating head [400] may be provided as a sterile, single use interventional catheter system, while the console unit [100] may be provided as a multiple use device that communicates with the sterile, single use interventional catheter system during operation.

Abstract: An interventional catheter assembly comprises an operating head for removing obstructive material from a target site in a body lumen or cavity and at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the aspiration port being in communication with a sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site. A rotatable member is positioned inside the catheter assembly at the site of the aspiration port and rotates during operation of the vacuum system. The rotatable member is provided with at least one upstanding bar that is sized to cooperate with the walls of the aspiration port and the inner surface of the catheter assembly to macerate debris that is drawn into the aspiration port.

Abstract: A bearing system useful in an intracorporeal device connects an operating head, a rotatable drive shaft and a catheter. The bearing system includes a static member in fixed communication with the distal end of the catheter, an interior shaft that is in rotatable communication with the drive shaft and the operating head, and at least one connecting structure. The static member has at least one opening through which the connecting structure moveably rests against a seat of the interior shaft. The position of the connecting structure within the seat enables the bearing to accept a rotational load of the rotating drive shaft and/or thrust load in the direction of the longitudinal length of the catheter. The connecting structure further retains the internal shaft and static member of the bearing system.

Abstract: A torque transmitting system supports rotational and lateral movement of a drive shaft. The system includes translating inner and outer tubes which have aligned canals for placement of a ball bearing and a pinion shaft to couple the tubes to a drive system. Rotational torque is transferred from the pinion shaft, to the outer tube and, through the ball positioned in the aligned canals, to the inner tube and then to the drive shaft. Furthermore, the ball engaged in the canals defines a range of motion in which the inner tube is slidable with respect to the outer tube, along the tubes' longitudinal axis, to permit advancement of an attached drive shaft.

Abstract: Intralumenal material removal systems are provided using an advanceable and rotatable cutter assembly designed for differential cutting. The intralumenal material removal system includes a cutter assembly positionable in the body cavity of a mammalian subject. One embodiment of the cutter assembly comprises a cutter with blades that are designed and arranged to form an acute blade angle of attack with the matter-to-be-removed. The cutter assembly is axially advanceable by translating the drive shaft and rotatable by rotating the drive shaft. The occlusive material is scraped by the cutter assembly and may be aspirated to remove the material from the body cavity. The cutter assembly may provide aspiration ports positioned between facing surfaces of the blades.

Abstract: An interventional catheter assembly comprises an operating head for removing obstructive material from a target site in a body lumen or cavity and at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the aspiration port being in communication with a sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site. A rotatable member is positioned inside the catheter assembly at the site of the aspiration port and rotates during operation of the vacuum system. The rotatable member is provided with at least one upstanding bar that is sized to cooperate with the walls of the aspiration port and the inner surface of the catheter assembly to macerate debris that is drawn into the aspiration port.

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: An interventional catheter assembly comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Abstract: An interventional catheter assembly has an operating head [400] and catheter system [300] that are inserted and navigated within a patient's body while an operator controls the system externally of the operating head. Fluidic communication is provided between the operating head and the external system controls, and rotation is provided to the operating head by means of an external drive system. Numerous system controls are provided, along with various operating systems, sealing assemblies, actuators, torque transfer systems, and the like are provided. Some systems and controls are provided in a control pod [200] and some controls, as well as displays, are provided in a console unit [100].

Abstract: A torque transmitting system supports rotational and lateral movement of a drive shaft. The system includes translating inner and outer tubes which have aligned canals for placement of a ball bearing and a pinion shaft to couple the tubes to a drive system. Rotational torque is transferred from the pinion shaft, to the outer tube and, through the ball positioned in the aligned canals, to the inner tube and then to the drive shaft. Furthermore, the ball engaged in the canals defines a range of motion in which the inner tube is slidable with respect to the outer tube, along the tubes' longitudinal axis, to permit advancement of an attached drive shaft.