Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

Abstract

A thrombectomy removal system includes a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion, a vacuum source, a vent liquid source, and a vacuum and vent control system configured to cyclically connect or disconnect the vacuum source and the vent liquid source to change a level of vacuum at the distal end and substantially prevent forward flow. The vacuum source and the vent source are respectively fluidically connected to the vacuum and vent valves. A manifold connects the proximal portion to the vacuum and vent sources through the valves. Control of the valves prevents forward flow of the distal portion out from the distal end during each cycle. Each cycle can have states including vacuum-only, first double-closed, vent-only, and second double-closed. A time of the double-closed states can be no greater than 30 ms.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the priority, under 35 U.S.C. § 119, of copending U.S. Provisional Patent Application Nos. 62 / 701,086, filed Jul. 20, 2018, and 62 / 750,011, filed Oct. 24, 2018; the prior applications are herewith incorporated by reference herein in their entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]Not ApplicableFIELD OF THE INVENTION[0003]The present systems, apparatuses, and methods lie in the field of thrombus removal. The present disclosure relates to an aspiration thrombectomy system and methods for thrombus removal with aspiration catheter.BACKGROUND OF THE INVENTION[0004]Ischemic strokes are usually caused by a blood clot that blocks or plugs a blood vessel in the brain. This blockage prevents blood from flowing to the brain. Within minutes, brain cells begin to die, which, if not treated rapidly, causes brain damage or death. The costs associated with removing a clot are significant. Most t...

AI Technical Summary

Benefits of technology

[0013]The systems, apparatuses, and methods described provide an aspiration thrombectomy system and methods for thrombus removal with an aspiration thrombectomy system that overcome the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that provide such features with increased first-pass recanalization rate by completely pulling the embolus out and, thereby, reducing the instance of aspiration catheter obstruction / clogging by the embolus.

[0014]The systems, apparatuses, and methods provide an aspiration thrombectomy system that completely vacuums up the clot so that clots are no longer dragged out of vasculature while half hanging out of a catheter tip. The aspiration thrombectomy system moves the vacuumed clot all the way to the proximal end of the vacuum channel and allows the surgeon to confirm recanalization of the vessel in which the clot formerly resided (for example, by injecting contrast through the catheter that remains in place after clot removal) and provides structure to indicate to the surgeon that the thrombus has been removed and that flow has been restored.

[0015]The systems, apparatuses, and methods provide an aspiration thrombectomy system that can be coupled with conventional aspiration catheters to significantly increase the efficacy of such catheter and pump systems. Vacuum level is indicated herein in two different ways:

Problems solved by technology

Within minutes, brain cells begin to die, which, if not treated rapidly, causes brain damage or death.

The costs associated with removing a clot are significant.

Conceptually, aspiration is effective but some significant problems occur in practice.

The other option is not viable, that is, reversing the suction to pressurize the clot and eject it forcibly and uncontrollably out of the distal opening of the aspiration catheter.

Such action is dangerous to the patient for many reasons, the primary one being that forcibly and uncontrollably ejecting the clot may cause the clot to move further distally within the vessel in which it was originally lodged.

That distal movement would not only cause the clot to be further within the vessel—i.e., in an even smaller diameter of the vessel than when it was originally lodged—but it could permanently lodge the clot into that vessel, making it impossible to remove, or it could burst the vessel.

Even when the surgeon uses the aspiration catheter to fish out the clot, there is no assurance that the entirety of the clot will be removed.

Pieces of the clot can break off during movement, when that occurs, the pieces re-embolize within the same vessel or within different vessels that might be even more difficult to remove.

When all or most of the clot is drawn out from the patient, it is difficult to confirm that the entire thrombus was removed.

A significant disadvantage of current thrombus removal devices is the inability of a surgeon to ascertain thrombus capture / removal without the full withdrawal of a given therapeutic device from a patient's anatomy.

Even systems capable of fully aspirating a given thrombus are problematic, because the reservoirs into which aspirated contents are deposited are located outside of the sterile field in an operating room setting.

This location, outside the sterile field, makes it difficult or impossible for physicians operating aspiration catheters to easily visualize and appraise aspirated thrombus material.

The aspiration and balloon guide catheters have to be cleaned out, access to distal anatomy has to be re-established, and, when the aspiration catheter finally is located back at the embolism site, the same issues may be present again with whatever embolus material remains.

A disadvantage of these procedures is the significant increase in procedure time, which not only significantly increases the cost (as each minute in an operating room is expensive), it also increases the surgeon's stress, which decreases the success rate of the operation.

Even with an attempt to maintain vacuum pressure utilizing manual periodic cycling, prior art systems are not capable of avoiding positive pressures at the distal end of the catheter.

Prior art systems are not able to react quickly enough to keep the distal end of the catheter from experiencing a positive pressure.

The prior art do not have a fast enough reaction time to quell forward flow.

Such systems cannot guarantee removing all forward flow eliminating positive pressure at the distal end of the catheter.

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