Patent No. US11793972 (titled "Rapid aspiration thrombectomy system and method") on Jan 19, 2021. The application was issued on Oct 24, 2023.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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