Patent No. US10213582 (titled "Methods and systems for treatment of acute ischemic stroke") on Dec 19, 2017. The application was issued on Feb 26, 2019.
’582 is related to the field of neurovascular intervention, specifically focusing on systems and methods for accessing and treating occlusions in the cerebral and intracranial arteries. The background context involves the critical time-sensitivity of treating acute ischemic stroke, where traditional transfemoral approaches often face challenges due to the long, tortuous pathway through the aortic arch and cervical arteries, which can delay treatment and increase the risk of embolic complications.
The underlying idea behind ’582 is to optimize the delivery of interventional tools to the brain by utilizing a specialized coaxial system that minimizes the structural transitions between devices. By integrating a catheter with a tapered inner member that extends beyond the catheter’s distal tip, the invention creates a smooth profile that can more easily navigate the sharp bends of the internal carotid artery. This engineering insight addresses the 'step-up' problem where catheters often catch on vascular anatomy or side branches during advancement.
The claims of ’582 focus on a method for performing a medical procedure at a treatment site in a cerebral vessel using a specific assembled coaxial system. The independent claim requires a catheter and a tapered inner member extending through the catheter lumen such that the inner member's distal end is positioned distal to the catheter's end. The method specifically covers the simultaneous advancement of this assembled system from a transfemoral access site through the internal carotid artery and into the distal vasculature beyond the petrous portion.
In practice, the tapered inner member acts as a bridge between a fine guidewire and the larger aspiration or treatment catheter. This configuration allows the entire assembly to be pushed as a single unit through the most challenging segments of the neurovasculature, such as the carotid siphon. Once the catheter reaches the face of the thrombus, the inner member is removed, leaving a large-bore lumen available for high-volume aspiration or the deployment of mechanical thrombectomy tools like stent retrievers.
This approach differs from prior solutions by eliminating the need for multiple sequential device exchanges that often lose access or cause vessel trauma. By maintaining a smooth transition at the leading edge of the system, the invention reduces the mechanical resistance encountered at the ophthalmic artery and other bifurcations. Furthermore, the system is designed to provide superior pushability and stability, ensuring that even large-diameter catheters can reach distal cerebral sites that were previously only accessible by much smaller, less effective devices.
In the mid-2010s when ’582 was filed, neurovascular interventions were typically implemented using a transfemoral approach, requiring long-reach catheters to navigate the complex geometry of the aortic arch and cervical arteries. At a time when systems commonly relied on catheter lengths exceeding 100 cm to reach intracranial targets from a femoral access point, the resulting friction and tortuosity often compromised device torque and trackability. Furthermore, when hardware constraints made the management of embolic debris non-trivial, standard practices often involved manual syringe aspiration or distal filters that added procedural complexity and time in clinical scenarios where rapid reperfusion was critical.
The disclosed invention represents a technical advancement through an architectural shift toward a direct transcarotid access system that significantly reduces the navigation path to the cerebral vasculature. By integrating a specialized arterial access sheath with a shortened catheter body—specifically optimized to a length of 40 cm to 70 cm—the system enables a more direct and stable transition from the access site to intracranial targets. This structural configuration overcomes the technical constraints of traditional long-reach systems by providing a distalmost section with specific flexibility ratios and a stiff proximal section that resides in the common carotid artery, enhancing support and control. The resulting assembly enables faster access and improved flow control for aspiration, addressing the critical technical problem of time-sensitive reperfusion while minimizing the embolic risks associated with traversing the aortic arch.
The patent contains a total of 19 claims, with claim 1 being the sole independent claim. This independent claim focuses on a method for performing a medical procedure within a cerebral vessel by assembling and advancing a coaxial system, consisting of a catheter and a tapered inner member, through the internal carotid artery from a transfemoral access point. The dependent claims serve to further define the method by specifying steps for removing occlusive material, detailing the physical dimensions and structural components of the catheter and inner member, and describing the use of auxiliary tools such as guidewires, stents, and arterial access devices.
Definitions of key terms used in the patent claims.
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