Systems and methods for management of thrombosis
Inventors
Look, David M. • CULBERT, BRADLEY S.
Assignees
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Publication Number
US-11540847-B2
Publication Date
2023-01-03
Expiration Date
Abstract
An aspiration system includes an aspiration catheter 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 an elongate tubular member and into the vasculature of a subject, 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, a high pressure injection lumen extending within the elongate support member and having a distal end including a curved portion configured to change a direction of fluid flow by at least about 90°, at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid to be released into the lumen of the tubular aspiration member, and an annular seal carried by the tubular aspiration member and configured to create a liquid seal against the inner surface of the elongate tubular member.
Core Innovation
The invention relates to an aspiration system for removal of material from a lumen, cavity or duct of a patient. The system includes an aspiration catheter having a proximal end and a distal end, and configured to be inserted through a lumen of an elongate tubular member that extends into the vasculature of a subject. The aspiration catheter includes a tubular aspiration member with a lumen that at least partially extends out of the lumen of the elongate tubular member at the distal end and into the vasculature.
The invention provides a composite annular sealing member carried by the tubular aspiration member, configured to create a liquid seal against an inner surface of the elongate tubular member. The composite annular sealing member comprises an o-ring and an elastomeric coating, where the o-ring is carried on an outer surface of the tubular aspiration member and the elastomeric coating covers an outer diameter of the o-ring and adjacent outer surface regions immediately proximal to and immediately distal to the o-ring. The elastomeric coating extends continuously from the outer surface of the tubular aspiration member proximal to the o-ring to the outer surface distal to the o-ring.
Additional embodiments describe high-pressure liquid delivered through a high-pressure injection lumen having a distal curved portion and distal orifices that release jets into the aspiration lumen to macerate thrombus and lower effective viscosity before aspiration under vacuum. A composite seal lip geometry is also described in which a distally facing lip flexes under pressure to reduce drag during tracking. System concepts further include aspiration monitoring using an in-line pressure transducer to detect vacuum loss, clogging, leaks, and active thrombus aspiration, and assisted aspiration configurations that include a pump and fluid/aspiration lumens with optional flow-control or expandable aspiration lumens.
Claims Coverage
The provided claim material includes one independent aspiration system claim and dependent refinements. The independent claim includes three core inventive features: the tubular aspiration member arrangement, the elongate support member coupling, and the composite annular liquid sealing member including an o-ring and an elastomeric coating.
Tubular aspiration member extending from guiding tubular lumen
An aspiration catheter with a tubular aspiration member having a lumen, configured to at least partially extend out of the lumen of an elongate tubular member at the distal end and into the vasculature of the subject.
Elongate support member coupling between catheter proximal and aspiration member proximal
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.
Composite annular sealing member forming a liquid seal with o-ring and elastomeric coating
A composite annular sealing member carried by the tubular aspiration member, configured to create a liquid seal against the inner surface of the elongate tubular member, where the composite annular sealing member comprises an o-ring and an elastomeric coating, with the o-ring carried on an outer surface of the tubular aspiration member and the elastomeric coating covering an outer diameter of the o-ring and covering the outer surface of the tubular aspiration member immediately proximal to the o-ring and immediately distal to the o-ring, the elastomeric coating extending continuously from the outer surface proximal to the o-ring to the outer surface distal to the o-ring.
Elastomeric coating covering an o-ring over a defined longitudinal distance
The elastomeric coating covers an o-ring and the outer surface of the tubular aspiration member along a longitudinal distance between 0.38 cm and 2 cm.
Composite seal with a relative outer diameter step at the elastomeric coating
The composite annular sealing member includes two different outer diameters over an elastomeric coating, where a first outer diameter is greater than a second outer diameter adjacent the o-ring.
Elastomeric coating thickness not exceeding a threshold
The elastomeric coating has a thickness of 0.001 inches or less.
High-pressure injection lumen with distal orifice releasing liquid into the aspiration lumen
A high-pressure injection lumen with a distal orifice releases injected liquid into the lumen of the tubular aspiration member.
Guiding catheter connector to a vacuum source with liquid sealing against guiding catheter inner surface
A guiding catheter having a proximal connector that couples the guiding catheter lumen to a vacuum source, where the composite annular sealing member forms a liquid seal against the guiding catheter inner surface.
The inventive subject matter centers on an aspiration catheter in a vasculature using a composite annular sealing member to form a liquid seal against an inner surface of an elongate tubular member, combined with an arrangement of a tubular aspiration member and an elongate support member. Dependent refinements further specify sealing coverage, outer diameter relationships, coating thickness, and add high-pressure injection with a distal orifice as well as a guiding catheter connected to a vacuum source while maintaining the liquid seal.
Stated Advantages
Reduces drag during tracking by flexing a distally facing lip under pressure.
Increases effective aspiration flow compared with a standard catheter, as supported by described flow resistance and vacuum-driven water-fill tests.
Enables real-time detection of vacuum loss, clogging, leaks, and active thrombus aspiration using an in-line pressure transducer.
Prepares thrombus for aspiration by macerating thrombus with injected jets and lowering effective viscosity before vacuum aspiration.
Documented Applications
Removal of thrombus from a blood vessel using an aspiration catheter and vacuum aspiration as described in the system context.
Aspiration system configurations that support aspiration monitoring and detection of conditions including vacuum loss, clogging, and leaks during thrombus aspiration.
Assisted aspiration configurations including pump/displacement pump and fluid/aspiration lumens, as described for thrombus aspiration contexts.
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