Methods and systems for treatment of acute ischemic stroke

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.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical Landscape

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.

Prosecution Position

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Cerebral vessel
(Claim 1)
The methods and devices enable access to the cerebral and intracranial arteries to treat acute ischemic stroke. These include the target cerebral vascular treatment site where an occlusion may be located.An artery located within the cranium that supplies blood to the brain, specifically targeted for the removal of occlusions or thrombi.
Coaxial system of devices
(Claim 1)
The system of devices for treating an artery comprises an arterial access sheath, an elongated dilator positionable within the internal lumen of the sheath body, and a catheter. These components are designed such that the arterial access sheath and the dilator can be collectively introduced into the artery.An assembly of multiple elongated medical components nested within one another along a common longitudinal axis to function as a single unit during advancement.
Internal carotid artery
(Claim 1)
A balloon-tipped guide catheter is used to access the internal carotid artery (ICA) from the femoral artery. The catheter body is sized and shaped to be navigated distally to an intracranial artery through the common carotid artery.A major paired artery, arising from the common carotid artery, that supplies blood to the brain and serves as the primary conduit for neurovascular catheters.
Petrous portion
(Claim 1)
The catheter body is sized and shaped to be navigated distally to an intracranial artery through the common carotid artery. This navigation involves reaching the cerebral and intracranial arteries to treat acute ischemic stroke.The segment of the internal carotid artery that passes through the petrous part of the temporal bone, serving as a landmark for distal navigation toward intracranial vessels.
Tapered inner member
(Claim 1)
The system includes an elongated dilator positionable within the internal lumen of the sheath body. The arterial access sheath and the dilator can be collectively introduced into the common carotid artery.An elongated component, such as a dilator, positioned inside a catheter lumen with a distal end that narrows in diameter to facilitate smooth vessel penetration and navigation.
Transfemoral access site
(Claim 1)
Most neurovascular interventional procedures use a transfemoral access to the carotid or vertical artery and thence to the target cerebral or intracranial artery. These catheters access the arterial system from the femoral artery and must navigate the aortic arch.A surgical or percutaneous entry point located at the femoral artery in the groin used to introduce catheters into the arterial system.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:24-cv-01108Oct 7, 2024Route 92 Medical, Inc. V. Q'Apel Medical, Inc.

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US10213582

Application Number
US15847255A
Filing Date
Dec 19, 2017
Publication Date
Feb 26, 2019
External Links
Slate, USPTO , Google Patents