Methods and systems for treatment of acute ischemic stroke

Patent No. US10646239 (titled "Methods and systems for treatment of acute ischemic stroke") on Aug 30, 2018. The application was issued on May 12, 2020.

What is this patent about?

’239 is related to the field of neurointerventional surgery, specifically focusing on methods and devices for accessing the cerebral vasculature to treat acute ischemic stroke. Traditional transfemoral access routes are often hindered by extreme tortuosity and the risk of dislodging embolic debris from the aortic arch. This invention addresses the need for a more direct, stable, and efficient pathway to the brain by utilizing a transcervical approach through the common carotid artery.

The underlying idea behind ’239 is to minimize the mechanical resistance and 'step-off' transitions that typically occur when navigating large-bore catheters through the tight curves of the internal carotid artery. By utilizing a tapered inner member that fits precisely within a distal catheter, the system creates a smooth, continuous profile that tracks over a guidewire without catching on vascular anatomy. This structural synergy allows a relatively large aspiration catheter to be advanced much further into the delicate cerebral vessels than previously possible.

The claims of ’239 focus on a method for advancing a specialized system of devices distal to the petrous portion of the internal carotid artery. The method requires a catheter and a single-lumen inner member to be locked into a specific advancement configuration where the inner member’s distal portion extends beyond the catheter tip. This inner member must feature a diameter that tapers distally and a flexibility gradient that ensures its leading edge is significantly more flexible than the catheter it precedes.

In practice, the system is advanced as a single unit, with the inner member acting as a high-performance dilator that bridges the gap between a fine guidewire and the larger treatment catheter. This coaxial advancement is critical for navigating the 'S-shaped' carotid siphon. Once the target treatment site is reached, the inner member is removed, leaving the large-bore catheter in place to provide maximum suction force for mechanical thrombectomy or to serve as a conduit for other interventional tools.

This approach differs from prior solutions by eliminating the 'tri-axial' mismatch where multiple nested catheters create ridges that can damage vessel walls or impede progress. By integrating a flexibility transition directly into the tapered inner member, the invention allows for a shorter, straighter transcervical path that significantly reduces the time required to restore blood flow. This streamlined navigation is essential in stroke treatment, where reducing 'door-to-recanalization' time is the primary determinant of patient outcomes.

How does this patent fit in bigger picture?

Technical Landscape

In the early 2010s when ’239 was filed, neurointerventional procedures for treating ischemic stroke were typically implemented using a transfemoral access route, where catheters were navigated from the femoral artery through the aortic arch to reach the cerebral vasculature. At a time when systems commonly relied on long, flexible guide catheters to traverse this tortuous anatomy, hardware constraints made the rapid delivery of large-bore thrombectomy devices non-trivial due to the risk of dislodging embolic debris from the aortic arch or carotid origins. Furthermore, standard practices for managing embolic risk during clot retrieval often relied on manual aspiration via syringes, which made the precise control of flow rates and the maintenance of continuous suction difficult for a single operator.

Prosecution Position

The disclosed invention represents a technical advancement in neurovascular intervention through the integration of a direct transcervical access architecture that provides a shorter, less tortuous path to cerebral occlusions compared to traditional routes. By establishing an access point in the common carotid artery above the clavicle, the system enables a structural shift that bypasses the aortic arch, thereby reducing the risk of procedural embolic showers and improving the speed of device delivery. The technical solution achieves enhanced procedural control by combining a transcervical access sheath with a distal catheter and a specialized inner member that creates a smooth transition for guidewire navigation, overcoming the constraints of vessel delicacy and access difficulty. This configuration enables a more stable platform for aspiration and mechanical thrombectomy, facilitating the rapid restoration of blood flow while minimizing the potential for distal embolization.

Claims

The patent contains a total of 30 claims, with claim 1 serving as the sole independent claim. This independent claim focuses on a method for performing medical procedures in cerebral vessels by utilizing a specific system of devices, including a catheter and a tapered, flexible inner member, that are advanced concurrently into the internal carotid artery. The dependent claims generally serve to further define the physical dimensions and flexibility gradients of the inner member, specify additional procedural steps such as the use of stent retrievers or negative pressure for clot removal, and detail the delivery of therapeutic agents or the navigation of specific arterial branches.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Advancement configuration
(Claim 1)
The system is positioned in an advancement configuration by inserting the inner member into the catheter lumen until the distal portion of the inner member is positioned distal to the distal end of the catheter. In this configuration, the inner member and catheter are held fixed relative to each other. This allows the catheter and inner member to be advanced together as a single unit through the vasculature.A specific operational state of the system where the inner member is inserted coaxially through the catheter lumen, its tapered distal portion extends beyond the catheter's distal end, and the two components are held fixed relative to one another to facilitate simultaneous movement through the vasculature.
Cerebral vessel
(Claim 1)
The methods and devices enable safe, rapid and relatively short and straight transcervical access to the cerebral arteries to treat acute ischemic stroke. The distal catheter is sized and shaped to be inserted axially through the internal lumen of the transcervical access sheath such that the distal catheter can be inserted into a cerebral artery.The target arterial vasculature within the brain where an occlusion is located and where the distal catheter is positioned for treatment.
Inner member
(Claim 1)
The inner member has an outer diameter configured to form a smooth transition between the inner diameter of the distal catheter and the outer diameter of a guidewire. The inner member transitions in flexibility from a proximal end to a distal end, with the distal end being more flexible than the distal end of the catheter. It is sized and shaped to be inserted axially through the lumen of the catheter.An elongated, flexible component with a single internal lumen and a distally tapering outer diameter, designed to reside within the catheter to provide a smooth transition and variable flexibility during navigation.
Petrous portion
(Claim 1)
The methods and devices enable access to the cerebral arteries to treat acute ischemic stroke. The system is designed to be advanced distal to a petrous portion of an internal carotid artery. This allows the distal catheter to be positioned in the cerebral artery adjacent to an occlusion.A specific anatomical segment of the internal carotid artery located within the petrous part of the temporal bone, serving as a landmark for the distal advancement of the treatment system.
Tapers distally
(Claim 1)
The inner member has a distal portion having a first outer diameter that tapers distally to a second outer diameter that is smaller than the first outer diameter. This tapered distal portion is positioned distal to the distal end of the catheter when in the advancement configuration. This geometry provides a smooth transition for atraumatic advancement.A reduction in the external diameter of the inner member's distal portion from a larger first diameter to a smaller second diameter to create a low-profile leading edge.
Transcervical access
(Claim 1)
Transcervical access provides a short length and non-tortuous pathway from the vascular access point to the target cerebral vascular treatment site. This access route reduces the risk of emboli generation from navigation of diseased, angulated, or tortuous aortic arch or carotid artery anatomy. The access is achieved via an opening directly in the common carotid artery positioned above the patient's clavicle and below a bifurcation location.A surgical approach to the carotid artery through an incision in the neck, positioned above the clavicle and below the carotid bifurcation, providing a direct route to the cerebral vasculature.
Transitions in flexibility
(Claim 1)
The inner member transitions in flexibility from a proximal end of the inner member to a distal end of the inner member. The distal end of the inner member is more flexible than the distal end of the catheter. This gradient in flexibility facilitates navigation through tortuous neurovascular anatomy.A progressive change in the stiffness of the inner member along its longitudinal axis, specifically where the distal tip is more pliable than the proximal portion and the catheter it inhabits.

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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US10646239

Application Number
US16117753A
Filing Date
Aug 30, 2018
Publication Date
May 12, 2020
External Links
Slate, USPTO , Google Patents