Penumbra, Inc.

A hemostasis valve for use with catheters in intravascular procedures. The hemostasis valve comprising a sealable fluid channel that bifurcates from a single distal lumen to two proximal lumens. An upper proximal lumen may include a funnel shaped opening to improve aspiration potential. Rotating locking mechanisms are attachable at the ends of the hemostasis valve to interlock coaxial devices or to form seals around coaxial devices. Injection molding may be used to manufacture a hemostasis valve and its components. A mold and core pins may impart external and internal shapes to a molten polymer. Once the polymer has cooled, the molded component is separated from any pins or molds and attached to other molded components to form an assembled hemostasis valve.

A sensor-controlled thrombectomy system includes an aspiration catheter, an aspiration pump, a collection canister, aspiration tubing, an external unit separate containing a medial portion of the aspiration tubing, a sensing unit within the external unit, and a controller that can utilize an algorithm to generate pressure pulses in the sensor-controlled thrombectomy system. During a thrombectomy procedure, the controller can operate the sensor-controlled thrombectomy system in a first mode to generate pressure pulses at a first pulse frequency to minimize blood loss while extracting a thrombus, detect, directly via the sensing unit, a first measure of flow through the aspiration tubing, and operate, automatically in response to the detected first measure of flow, the sensor-controlled thrombectomy system in a second mode to generate pressure pulses at a second pulse frequency, the second pulse frequency being an increased frequency relative to the first frequency to boost optimization for extracting the thrombus.

Systems and methods are presented herein for detecting different engagement conditions of a separator instrument of a system. Processing circuitry is used to establish a baseline of one or more operational parameters for the separator instrument. At least one deviation from the established one or more baseline operational parameters of the separator instrument is identified using the processing circuitry. The processing circuitry is used to determine that the identified at least one deviation corresponds to at least one engagement condition of the separator instrument. An action is caused to be performed based on the determining by the processing circuitry.

A dynamic aspiration system includes a vacuum source, an aspiration catheter, a connecting tube, controllable valves to control a level of pressure in the aspiration catheter or the connecting tube, pressure sensors to detect pressure readings, and a controller capable of utilizing an artificial neural network (ANN) trained to predict flow state classifications. The controller may receive pressure readings from the sensors, provide the pressure readings as input data for the ANN, classify, via the ANN, a current flow state in the aspiration catheter or the connecting tube based on outputs generated by the ANN, and operate the controllable valves based on the classification of the current flow state. The controller operates the controllable valves in a first pressure protocol if the classification by the ANN is restricted or obstructed, and operates the controllable valves in a second pressure protocol if the classification by the ANN is unrestricted.

A blood clot removal system including an aspiration catheter, an external unit having a first pressure sensor, a base unit having a second pressure sensor, a vacuum source connected to the base unit, connection tubing connecting the external unit to the aspiration catheter and the base unit, controllable sensory indicators, and a controller to receive a first pressure from the first pressure sensor and a second pressure from the second pressure sensor, determine a pressure differential based on the first pressure and the second pressure, determine a current catheter state from a plurality of catheter states based on the pressure differential, and transmit, via the one or more sensory indicators, one or more sensory indications of the current catheter state.

An aspiration thrombectomy system including an aspiration catheter having a proximal portion, a distal end and a lumen extending through the catheter, a vacuum source fluidically coupled to the catheter, a vacuum valve connected between the vacuum source and the proximal portion of the catheter to control a vacuum flow in the catheter lumen, a vent valve fluidically coupled to the proximal portion of the catheter, the vent valve being configured to control a flow of a vent fluid in the catheter lumen, and a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle to change a level of vacuum at the distal end of the catheter and to control fluid flow in and out from the distal end of the catheter.

A platform of computing systems is configured to receive thrombectomy procedure data that is associated with a user of an aspiration thrombectomy system. The procedure data includes sets of temporal datapoints associated with a thrombectomy procedure. The platform of computing systems is further configured to generate thrombectomy analytics data based on baseline procedure data and the sets of datapoints. The platform of computing systems is further configured to visually display the thrombectomy analytics data, and to provide comparative data metrics for selection on an interactive interface.

An aspiration thrombectomy system for use with an aspiration catheter, connection tubing to place a vacuum source and the aspiration catheter in fluid communication, controllable valves to control a level of negative pressure provided by the vacuum source, ultrasonic sensors to detect ultrasonic energy in the aspiration catheter or the connection tubing, and an automated controller to generate, via the controllable valves, while the system is operated in a first operational state, a pressure wave in the aspiration catheter or the connection tubing, detect, via the ultrasonic sensors, ultrasonic energy in the aspiration catheter or the connection tubing based on ultrasonic energy originating from the ultrasonic sensors, determine, based at least in part on the generated pressure wave and the detected ultrasonic energy, a system state in the aspiration catheter or the connecting tubing, and operate, based on the determined system state, the system in a second operational state.

In one embodiment, an aspiration thrombectomy system includes an aspiration catheter having a proximal end, a distal end, and a lumen to accommodate fluid, a first valve capable of removing fluids from the system to alter a level of pressure in the system in a first manner, a second valve capable of providing fluids into the system to alter the level of pressure in the system in a second manner, and a cutting instrument at the distal end of the aspiration catheter having a spiral body connected to a rounded element having a scooped-out portion for engaging a target occlusive material, the cutting instrument being capable of axial and rotational motion, and the system being capable of cutting and removing the occlusive material based on the motions of the cutting instrument and one or more of the first manner and the second manner of altering the level of pressure.

A containing element is used to capture material in a blood vessel for removal. The containing element is advanced through the blood vessel or a catheter in a constricted configuration. A control body is coupled to the containing element which assists moving the containing element. In some embodiments, the containing element is used for restricting blood flow within a vessel.