Rapid aspiration thrombectomy system and method

Patent No. US11793972 (titled "Rapid aspiration thrombectomy system and method") on Jan 19, 2021. The application was issued on Oct 24, 2023.

What is this patent about?

’972 is related to the field of neurovascular access systems, specifically designed for navigating the complex and delicate anatomy of the cerebral arteries. The technology addresses the critical need for rapid and safe removal of blood clots in patients suffering from acute ischemic stroke, where the time to reperfusion is the primary determinant of clinical outcomes. By optimizing the mechanical transition between access sheaths and treatment catheters, the system facilitates the delivery of interventional tools to distal occlusive sites.

The underlying idea behind ’972 is the use of a specialized dilator or catheter component featuring a tapered distal region constructed from unreinforced polymer to provide a highly atraumatic interface with the vessel wall. Unlike standard vascular dilators designed for blunt tissue dissection, this invention utilizes a specific arrangement of fluoroscopic markers to define the boundaries of this tapered zone. This allows the operator to precisely monitor the transition from the flexible tip to the maximum diameter of the device, ensuring smooth tracking through tortuous neurovascular bends without damaging fragile arterial linings.

The claims of ’972 focus on an intravascular access catheter characterized by a flexible elongate body with a single lumen and a specific tapered region located at its distal end. A critical structural requirement of the independent claims is the placement of a first fluoroscopic marker at the distal end of this taper and a second fluoroscopic marker at the proximal-most end of the taper. This second marker is specifically configured to identify the point where the device reaches its maximum outer diameter, which is sized to maintain a slip fit within the lumen of a larger outer access catheter.

In practice, the system functions by nesting the flexible elongate body within an outer sheath to create a smooth, continuous transition for navigating the vasculature. The unreinforced polymer in the tapered region provides the necessary flexibility to negotiate the 90-degree or greater turns common in the internal carotid artery. The dual-marker system provides the clinician with real-time feedback, ensuring that the transition zone is properly positioned relative to the outer catheter's distal tip, thereby preventing the 'shelf' effect that often hinders the advancement of large-bore catheters in diseased vessels.

This approach differs from prior solutions by integrating the navigation and access functions into a single, contiguous luminal path that maximizes aspiration force. By utilizing a proximal extension that leads to an extracorporeal end, the device maintains a consistent internal diameter for suctioning clots while minimizing the profile of the hardware residing within the patient. The specific use of a slip-fit maximum diameter identified by a proximal taper marker ensures that the device can be exchanged or advanced rapidly without the friction or mechanical resistance typically encountered in multi-component neurovascular systems.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’972 was filed, endovascular treatment for acute ischemic stroke was typically implemented using a coaxial assembly of nested catheters, where an intermediate aspiration catheter was advanced through a larger guide catheter to reach the neurovasculature. At a time when these systems commonly relied on full-length, concentric catheter bodies, the resulting stack of materials often created significant friction and limited the effective inner diameter available for aspiration. Furthermore, when hardware constraints made the rapid exchange of devices non-trivial, clinicians were often forced to choose between the stability of large-bore access and the flexibility required to navigate the tortuous anatomy of the cerebral arteries.

Prosecution Position

The disclosed invention represents a meaningful technical advancement through an architectural shift from full-length concentric catheters to a spined catheter system that optimizes the aspiration lumen. By coupling a flexible distal luminal portion to a rigid, eccentric proximal spine, the system enables a 'step-up' in diameter where the catheter lumen meets the larger access sheath lumen, creating a contiguous, high-volume aspiration conduit. This integration overcomes the technical constraint of flow resistance inherent in long, narrow catheters while maintaining the pushability required for neurovascular navigation. Additionally, the inclusion of a matching spined dilator that locks with the catheter spine enables the assembly to be advanced as a single unit, significantly reducing the time and complexity of device exchange and improving the efficiency of thrombus removal.

Claims

The patent includes a total of 26 claims, with claims 1 and 25 serving as the independent claims. These independent claims focus on an intravascular access catheter and a related system designed for neurovascular procedures, specifically featuring a flexible body with a tapered region made of unreinforced polymer, radiopaque markers to identify the taper and maximum diameter, and a proximal extension that creates a continuous internal lumen. The dependent claims provide additional details regarding the material composition of the proximal extension, specific dimensions and durometers of the tapered regions, the inclusion of hubs or lubricious materials, and the mechanical fit and compatibility of the device when used in conjunction with outer catheters or secondary medical systems.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Proximal extension
(Claim 1, Claim 25)
The access sheath can further include a proximal extension portion such that when the distal luminal portion of the catheter is withdrawn from the sheath body lumen it remains within the proximal extension portion. The spine can be a hypotube having a guide-wire passageway extending therethrough. The spine or extension is longer than an entire length of the sheath body to reach an extracorporeal position.A structural component extending from the proximal end of the flexible elongate body to a point outside the patient's body, containing a lumen that connects with the body's lumen.
Single, contiguous lumen
(Claim 1, Claim 25)
The luminal portion and the sheath body can be concentrically aligned and the lumen of the luminal portion and the lumen of the sheath body form a contiguous aspiration lumen from the distal end of the luminal portion to the proximal end of the sheath body. The contiguous aspiration lumen can be used to aspirate fluid and debris from the distal opening. It can also be used to deliver materials through the distal opening of the luminal portion.An uninterrupted internal passageway extending the entire length from the distal opening of the flexible body to the proximal opening of the proximal extension.
Slip fit
(Claim 25)
An outer diameter of the luminal portion fluidly seals with the inner diameter of the access sheath when the distal end of the luminal portion extends into the cerebral vessel. The outer diameter of the luminal portion can approach the inner diameter of the lumen of the sheath body such that a seal is formed by the overlap region. This configuration allows the catheter to move through the sheath body while maintaining a seal against vacuum or pressure.A dimensional relationship where the maximum outer diameter of the inner catheter is slightly smaller than the inner diameter of the outer catheter, allowing for sliding movement and fluid sealing.
Tapered region
(Claim 1, Claim 25)
The catheter can be tapered towards the distal opening such that a distal-most end of the luminal portion has a smaller outer diameter compared to a more proximal region of the luminal portion near where the luminal portion seals with the sheath body. The outer jacket layer can be composed of discreet sections of polymer with different durometers, compositions, and/or thicknesses to vary the flexibility along the length. This region is configured to facilitate navigation into cerebral arteries.A specific section of the flexible elongate body where the outer diameter decreases toward the distal end, constructed from an unreinforced polymer and bounded by fluoroscopic markers.
Unreinforced polymer
(Claim 1, Claim 25)
The luminal portion can include three or more layers including an inner lubricious liner, a reinforcement layer, and an outer jacket layer. The outer jacket layer can be composed of discreet sections of polymer with different durometers, compositions, and/or thicknesses. In specific regions, the reinforcement may be omitted to vary the flexibility along the length of the distal luminal portion.A polymer material used in the tapered region that lacks additional structural reinforcement layers, such as braiding or coils, to provide specific flexibility characteristics.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00986Aug 6, 2025Route 92 Medical, Inc. V. Balt Usa, Llc

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US11793972

Application Number
US17152581A
Filing Date
Jan 19, 2021
Publication Date
Oct 24, 2023
External Links
Slate, USPTO , Google Patents