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 diagnostic or therapeutic composition, or ports for infusing a diagnostic or therapeutic composition prior to, during or following an interventional procedure are 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 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: 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: Guidewire system includes a guidewire jacket, at least two guidewires, and a handle. The guidewires are initially constraint within the guidewire jacket and may be introduced into a diagnostic or other catheter to deliver the guidewires to a target region in a patient's vasculature. The handle detachably retains the guidewires so that they may be advanced simultaneously with the guidewire jacket. The guidewires may be then detached and manipulated individually to locate them properly within the region. After removing the guidewire jacket and the diagnostic catheter, the two or more guidewires provide a trackable yet flexible path for the introduction of interventional catheter or sheath.

Abstract: A sealing assembly hinders or prevents air or other fluid from seeping between various components of a medical device by use of a liquid seal. An infusion port is for introducing a sealing liquid to immerse a flood space between a liner that surrounds a torque tube and/or within the torque tube, thereby creating a liquid seal around the torque tube and lubricating the torque tube. The length of the liner and the cross sectional space of the flood space are adjusted to control flow rate. An aspiration port may force suction pressure into a lumen extending along the length of the medical device in a distal direction. The liquid seal also prevents diluting of the suction pressure by stopping ingress of air.

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: 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: 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 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: 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: 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: 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 includes 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 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 sealing assembly hinders or prevents air or other fluid from seeping between various components of a medical device by use of a liquid seal. An infusion port is for introducing a sealing liquid to immerse a flood space between a liner that surrounds a torque tube and/or within the torque tube, thereby creating a liquid seal around the torque tube and lubricating the torque tube. The length of the liner and the cross sectional space of the flood space are adjusted to control flow rate. An aspiration port may force suction pressure into a lumen extending along the length of the medical device in a distal direction. The liquid seal also prevents diluting of the suction pressure by stopping ingress of air.

Abstract: A tubular structure comprising multiple overlapping layers surrounding a lumen has flexibility and structural integrity by allowing portions of the layers to slip relative to each other. One embodiment includes a support layer having a wired coil, braid or weave support element underlies at least one overlying layer. The support layer is fixed to the overlying layer at a bonding point and the remaining portion of the support layer is not fixed to the overlying layer, i.e. “free portion”. The support layer is permitted to slip at the free portion of the support layer, relative to the overlying layer. Further flexibility may be provided by a coil element of the support layer having substantial gaps between the loops of the coil to impart high flexibility of the tubular structure.