Penumbra, Inc.

Scott Teigen

Stephen Joseph Pons

Ben Tompkins

Steven Loisel

Corey Teigen

Cheng Yong Timothy Thio

Lincoln Herbert Davidson

Robyn Shaffer

Vinita Verma

Bo-Yu Su

Steve Loisel

Evan T Koretsky

Anderson S Lee

Matthew W L Sprinkel

Aurko J Shaw

Melissa E R Jones

Annam K Quraishi

Akhilesh R R Yeluru

Nitika S Chellappa

Michael E Salamy

Bridget C Vaughan

Justin M Olshavsky

Robert D Schultz

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.

Neural network-aided aspiration thrombectomy system and methods for thrombus removal

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.

Aspiration thrombectomy system and methods for dynamic system state detection

A dynamic aspiration system includes a connecting tube, a vacuum source, a pressure source, an aspiration catheter, a first controllable valve to control a level of negative pressure provided by the vacuum source, a second controllable valve to control a level of positive pressure provided by the pressure source, pressure sensors, and a controller. The controller modulates the controllable valves to generate pressure pulses, determines, for each of the pressure pulses, a degree of success corresponding to a change in a flow in the aspiration catheter or the connecting tube responsive to the pressure pulse, identifies one or more first pressure pulses determined to have the highest degrees of success, and modulates the controllable valves to generate the first pressure pulses in one or more pressure pulse cycles.

Apparatus and methods for controlled clot aspiration

A vacuum aspiration control system for use with a vacuum source and an aspiration catheter includes a connection tubing configured to act as a fluid conduit between the vacuum source and the aspiration catheter. A controllable valve is configured to control a level of vacuum in the connection tubing provided by the vacuum source, and one or more pressure sensors are associated with the connection tubing. A controller is configured to periodically sample flow when the current flow state is unrestricted, utilize an artificial neural network to classify a flow state for the sampled flow, close the controllable valve if the flow state for the sampled flow is classified as unrestricted, and hold the controllable valve open if the flow state for the sampled flow is classified as restricted or obstructed.

A thrombectomy system includes a catheter having a proximal end and a distal end, a valve in fluid communication with the catheter, and a cutting instrument associated with the distal end of the catheter. The cutting instrument may be configured for axial and/or rotational motion. A controller of the system may be configured to detect operational parameters of the cutting instrument. The controller may determine whether the cutting instrument is engaging with occlusive material based on the detected operational parameters. The controller may operate the valve in one or more operating modes to alter a level of pressure in the catheter based on whether the cutting instrument is engaging with the occlusive material.

Thrombectomy systems and methods for controlled clot aspiration

An aspiration thrombectomy system for use with a vacuum source and an aspiration catheter includes an aspiration catheter, connection tubing configured to act as a common conduit for fluid communication between the aspiration catheter and a vacuum source, controllable valves operable to selectively open and close to control fluid flow, pressure sensors associated with the aspiration catheter or the connection tubing, and an automatic controller configured to operate the valves in a first operational state to generate fluid pressure changes, detect pressure levels in the system, wherein changes in the detected pressure levels are correlated with the generated fluid pressure changes, determine system states based on system state scores determined based on the detected pressure levels, the system state scores indicating a measure of occlusion in the aspiration catheter or the connection tubing, and operate the valves in a second operational state based on the determined system states.

A dynamic aspiration method including engaging a distal end of an aspiration catheter against an occlusion in a blood vessel, applying a vacuum through an aspiration lumen of the aspiration catheter using a vacuum source coupled to a proximal end of the aspiration lumen by a connecting tube, whereby portions of the occlusion are drawn into the aspiration lumen, through the connecting tube and into a collection receptacle by the vacuum source, sensing flow through the connecting tube, and automatically generating pressure differentials when a clog or restricted flow is detected.

An aspiration catheter assembly including an outer catheter having an elongate tubular body and a distal valve at a distal end of the aspiration catheter assembly, and an inner catheter configured to communicate with a vacuum source, the inner catheter being within the outer catheter and including an aspiration lumen for receiving at least a portion of a clot. The distal valve is configured to be opened and closed at the distal end of the aspiration catheter assembly, and the distal end of the aspiration catheter assembly is configured as a separator such that the portion of the clot can be separated at the distal end and drawn into the aspiration catheter assembly.

An aspiration thrombectomy system including an aspiration catheter having a proximal end and a distal end, the aspiration catheter having a lumen to accommodate fluid, a vacuum source including a controllable vacuum valve, a tubing connected to the aspiration catheter, and a controller configured to detect a change in a catheter diameter corresponding to a change in the connection between the aspiration catheter and the tubing. The controller is configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the catheter diameter, and the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

Venous infusion catheter assemblies and methods of use are described herein. A catheter assembly may comprise an elongated body having a proximal end and a distal end, with an expandable occlusion element disposed on the elongated catheter body. A catheter may include a first infusion lumen extending to a proximal infusion port positioned on the catheter body proximally of the occlusion element and a second infusion lumen extending to a distal infusion port. Some embodiments may use a suction lumen extending to at least one suction port. When the catheter is introduced into vasculature of a patient, the suction port may be positioned in the patient's superior vena cava or right atrium to draw blood, the distal infusion port is positioned to direct normothermic or hyperthermic fluid toward the patient's heart, and the proximal infusion port is positioned to create a flow of hypothermic fluid in the patient's cerebral vasculature.

Infusion catheter and methods of use

A vacuum aspiration control system for use with a vacuum source and an aspiration catheter includes a connecting tube configured to connect the vacuum source with a lumen of an aspiration catheter. An on-off valve is operatively coupled to the connecting tube, and a sensing unit is configured to detect flow within the connecting tube and provide a signal representative of flow. A controller receives the signal to decide whether to open or close the valve. The controller may automatically close the valve to stop flow when flow through the connecting tube is unrestricted, or according to a predetermined timing sequence. The controller can further periodically open a closed valve to determine whether flow has entered an acceptable range. The controller can still further engage pulsed aspiration with a pressure manipulation assembly when flow is restricted or occluded.

An aspiration thrombectomy system for use with a vacuum source and an aspiration catheter includes a connection tubing configured to selectively connect the aspiration catheter to the vacuum source via a controllable vacuum valve. A distal pressures sensor is configured to detect pressure at the distal end within the connection tubing. An automatic controller may operate the vacuum valve to generate fluid pressure change in the connection tubing, and detect pressure profiles in the connection tubing correlated with the generated pressure changes via the distal pressure sensor. The automatic controller may determine one or more system states in the aspiration catheter or connection tubing based on the detected pressure profiles, and may operate the vacuum valve based on the determination of system state.

An aspiration thrombectomy system, comprising an aspiration catheter having a proximal end and a distal end, wherein the proximal end of the aspiration catheter comprises a lumen configured to accommodate fluid, a vacuum source comprising a controllable vacuum valve, and a controller configured to detect a change in a connection between the aspiration catheter and the aspiration thrombectomy system, wherein the controller is further configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the connection between the aspiration catheter and the aspiration thrombectomy system, wherein the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

An aspiration thrombectomy system, comprising a vacuum source comprising a controllable vacuum valve, a pressure source comprising a controllable pressure valve, an aspiration catheter having a proximal end and a distal end, wherein the proximal end of the aspiration catheter comprises connection tubing having a lumen configured to accommodate fluid, and wherein the connection tubing acts as a common conduit for fluid communication between the aspiration catheter and the vacuum and pressure sources via the vacuum and pressure valves, respectively, and a controller configured to open and close the vacuum and vent valves in a predetermined cycle to change a level of vacuum at the distal end of the aspiration catheter and control flow in and out from the distal end of the catheter.

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West Fargo, ND, United States of America

Scott Teigen