Systems and methods for management of thrombosis

Inventors

Look, David M. • CULBERT, BRADLEY S.

Assignees

Incuvate LLC

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Publication Number

US-12002065-B2

Patent

Publication Date

2024-06-04

Expiration Date


Abstract

An aspiration system includes an elongate tubular member having a lumen; an aspiration catheter configured to be inserted through the lumen of the elongate tubular member, and including a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member; an elongate support member coupled to the tubular aspiration member and extending between a proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and an annular sealing member coupled to the tubular aspiration member and configured to create a seal against an inner surface of the elongate tubular member, when a vacuum sufficient to cause aspiration is actively applied to the lumen of the elongate tubular member.

Core Innovation

The invention is an aspiration catheter for thrombectomy in which a tubular aspiration member is inserted through a lumen of a guiding catheter and into the vasculature of a patient. The aspiration catheter includes a proximal end and a distal end, and the tubular aspiration member has a proximal end, a distal end, and a lumen. An elongate support member is coupled to the tubular aspiration member and extends between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member, with the elongate support member having a relatively small diameter in relation to the lumen of the tubular aspiration member.

The aspiration catheter further includes an annular sealing surface configured to form an annular seal against the inner surface of the guiding catheter. The annular sealing member provides an active, vacuum-driven seal to substantially prevent low-viscosity blood from passing through a distal-proximal annular gap during aspiration. The description includes multiple sealing structures for the annular sealing surface, including a distally facing lip, annular concavity and annulus configurations, lip or o-ring variants, and hydrogel seal embodiments, as well as hydrogel hydration behavior.

The disclosed system also includes aspiration embodiments with saline-assisted aspiration using high-pressure injection jets and orifices, where high-pressure liquid is delivered into the lumen of the tubular aspiration member. In addition, the invention includes an aspiration monitoring and clog-detection subsystem with an in-line pressure transducer and vacuum sensor connected to a measurement device and communications to provide alerts. The monitoring subsystem is described as detecting thrombus engagement, clogging conditions, and system leaks or loss of vacuum.

Claims Coverage

The partial content identifies one independent claim covering an aspiration catheter with a tubular aspiration member, an elongate support member, and an annular sealing surface configured to form an annular seal against the inner surface of the guiding catheter. Dependent refinements are provided for sealing structure and placement, and for an additional high-pressure injection lumen feature and related hub coupling.

Vacuum-sealed aspiration through a guiding catheter with an annular sealing surface

An aspiration catheter with a distal end configured to be inserted through a lumen of a guiding catheter into the vasculature of a patient, and an annular sealing surface coupled to the tubular aspiration member configured to form an annular seal against the inner surface of the guiding catheter.

Elongate support member with a relatively small diameter relative to the aspiration lumen

An elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member, where the elongate support member has a relatively small diameter in relation to the lumen of the tubular aspiration member.

High-pressure injection lumen with distal orifice into the tubular aspiration member

An aspiration catheter includes a high pressure injection lumen having a proximal and distal end, and an orifice near the distal end configured to permit high pressure liquid injected through the lumen to enter the lumen of the tubular aspiration member.

Annular sealing surface not on an inflatable balloon

The annular sealing surface of the aspiration catheter is not located on an inflatable balloon.

Annular sealing surface not user-expandable

The annular sealing surface of the aspiration catheter cannot be expanded by a user.

Annular sealing surface disposed on an elastomeric ring

An annular sealing surface disposed on an elastomeric ring.

Hub configured to decouple from the elongate support member’s high pressure injection lumen

The aspiration catheter includes a hub connected to the elongate support member configured to decouple from the elongate support member’s high pressure injection lumen.

Across the independent claim and its dependent refinements, the core claim coverage focuses on an aspiration catheter that forms an annular seal against the inner surface of a guiding catheter using an annular sealing surface, with an elongate support member having a relatively small diameter relative to the aspiration lumen. Additional dependents further specify sealing implementation constraints and add a high-pressure injection lumen with a distal orifice, optionally coupled or decoupled via a hub.

Stated Advantages

Substantially prevents low-viscosity blood from passing through a distal-proximal annular gap during aspiration.

Water-vacuum test results show increased extraction rates versus standard systems.

Aspiration monitoring detects thrombus engagement, clogging, and system leaks or loss of vacuum, with alerts communicated via communication devices.

Documented Applications

Thrombectomy aspiration using an aspiration catheter inserted through a lumen of a guiding catheter into the vasculature of a patient.

Saline-assisted aspiration using high-pressure injection jets and orifices to assist aspiration.

Clog detection and aspiration monitoring during aspiration using an in-line pressure transducer and vacuum sensor to detect thrombus engagement, clogging conditions, and system leaks or loss of vacuum.

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