Aspiration catheter systems and methods of use

Patent No. US11806032 (titled "Aspiration catheter systems and methods of use") on Dec 16, 2022. The application was issued on Nov 7, 2023.

What is this patent about?

’032 is related to the field of neurovascular intervention, specifically focusing on devices and methods for navigating the highly tortuous anatomy of the cerebral arteries to treat conditions like acute ischemic stroke. The technical context involves the challenge of advancing large-bore aspiration catheters through the carotid siphon and other sharp vascular bends without kinking the device or causing trauma to the vessel walls. Traditional systems often require complex, multi-operator step-wise advancement techniques that can delay critical blood flow restoration.

The underlying idea behind ’032 is the use of a specialized catheter advancement device that acts as a highly flexible, atraumatic internal support to bridge the gap between a guidewire and a larger aspiration catheter. By utilizing a variable-stiffness elongate body that transitions from a rigid proximal segment to an extremely soft, unreinforced polymer tip, the device eliminates the sharp 'lip' at the distal end of the outer catheter. This creates a smooth, tapered profile that allows the entire assembly to track through 180-degree turns in a single pass, maintaining the natural curvature of the anatomy rather than straightening it.

The claims of ’032 focus on a catheter advancement device characterized by a flexible elongate body with a single lumen extending its entire working length, featuring a constant inner diameter between 0.010″ and 0.024″ to accommodate a guidewire. The device is defined by a specific material and geometric transition: an intermediate segment made of a higher-durometer polymer and a tip segment made of a lower-durometer polymer. This tip segment must feature a continuous distal taper from a first outer diameter (0.048″ to 0.080″) down to a smaller second outer diameter at the distal-most opening.

In practice, the advancement device is coaxially loaded into an outer aspiration catheter so that its tapered tip extends beyond the catheter’s distal edge. This configuration is particularly effective because the outer diameter of the advancement device's intermediate segment is sized to fit snugly within the catheter lumen, minimizing the mechanical step-off that typically catches on branching vessels like the ophthalmic artery. The unreinforced polymer construction of the distal segments ensures that the device remains flexible enough to navigate the carotid siphon without ovalizing or kinking, even when bent back on itself.

This approach differs from prior solutions by replacing the traditional microcatheter in a tri-axial system with a dedicated, tapered dilator-like element that is optimized for the specific inner diameters of large-bore neurovascular catheters. Unlike standard microcatheters, which often have significant clearance gaps that lead to 'ledge effect' hang-ups, this invention utilizes staggered material transitions and a specific distal taper geometry to ensure a seamless transition of force. This allows a single operator to advance the system to the target site more rapidly, reducing the time required to initiate aspiration or deliver interventional tools.

How does this patent fit in bigger picture?

Technical Landscape

In the mid-2010s when ’032 was filed, endovascular treatment for acute ischemic stroke was typically implemented using tri-axial catheter systems consisting of a guide catheter, an intermediate catheter, and a microcatheter. At a time when these systems commonly relied on multiple overlapping full-length catheters, each requiring its own rotating hemostatic valve, the resulting stack of proximal connectors often created significant bulk and required a large working area at the base of the operating table. Furthermore, when hardware constraints made the navigation of tortuous neurovascular anatomy non-trivial, clinicians frequently struggled to maintain coaxial relationships between multiple devices, as the transition points between catheters could cause snagging or ledge effects that impeded smooth advancement into the intracranial vessels.

Prosecution Position

The disclosed invention represents a meaningful technical advancement through an architectural shift in catheter delivery systems that reduces proximal complexity while enhancing distal trackability. By integrating a flexible elongate body with a specific sequence of material transitions—ranging from a rigid proximal hypotube to a very low-durometer, unreinforced distal tip—the system overcomes the technical constraint of 'ledge effect' during navigation. The structural solution involves a tapered tip segment of at least 5 cm that extends beyond the catheter distal end, providing a smooth mechanical transition that enables the assembly to traverse the carotid siphon. Additionally, the use of a proximal extension with a reduced diameter relative to the distal luminal portion allows for a streamlined profile that simplifies the management of multiple coaxial devices and reduces the physical footprint of the system during high-stakes neurovascular procedures.

Claims

This patent contains 30 claims, with claims 1, 16, and 27 serving as the independent claims. The independent claims focus on a medical system and an intravascular catheter advancement device designed for navigating cerebral vessels, specifically featuring a flexible elongate body with a single lumen, a proximal segment for axial movement, and a distal tip segment that transitions to a smaller diameter and has a lower durometer than the intermediate segment to facilitate delivery through the vasculature. The dependent claims provide additional technical specifications, including specific taper angles and lengths, radiopaque marker placements, material hardness levels, wall thickness dimensions, the inclusion of lubricious additives or metallic reinforcements, and the integration of guidewires or pre-packaged catheter assemblies.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Catheter advancement device
(Claim 1, Claim 16, Claim 27)
The catheter advancement device is described as a flexible elongate body sized to be positioned coaxially within a catheter lumen such that a tapered portion extends distally beyond the distal end of the catheter to aid in delivery to an intracranial vessel. It is configured to allow for rapid access and optimized catheter aspiration to restore flow to blocked cerebral vessels.An intravascular tool, also referred to as a catheter advancement element, designed to be positioned coaxially within the lumen of a larger catheter to facilitate its delivery through complex neurovascular anatomy by providing a flexible, tapered leading edge.
Intermediate segment
(Claim 1, Claim 16, Claim 27)
The intermediate segment comprises an unreinforced polymer having a durometer of no more than 72 D. It may include a first segment with a material hardness of no more than 55 D and a second segment located proximal to the first with a hardness of no more than 72 D.A section of the flexible elongate body located between the proximal and tip segments, constructed from a polymer with a higher durometer than the tip to provide structural support while maintaining flexibility.
Proximal segment
(Claim 1, Claim 16, Claim 27)
The proximal segment can include a hypotube coated with a polymer, such as a skived hypotube of stainless steel coupled to a proximal hub. This segment is configured to move the catheter advancement device axially within the catheter lumen and may be coated with a lubricious polymer like PTFE.The portion of the advancement device used by the operator to control axial movement (pushing or pulling) within the outer catheter, often comprising a stiffer material like a hypotube.
Tip segment
(Claim 1, Claim 16, Claim 27)
The tip segment is formed of a polymer with a durometer of no more than about 35 D and has a length of at least 5 cm. It includes a tapered portion which tapers distally from a first outer diameter to a second outer diameter over a length of between 1 and 3 cm, acting as the most atraumatic element of the coaxial assemblage.The distal-most portion of the advancement device, characterized by a lower material hardness (durometer) than the proximal sections and a distally tapering outer diameter to provide an atraumatic transition.
Working length
(Claim 1, Claim 16, Claim 27)
The catheter advancement device has a length configured to extend from outside the patient's body, through the femoral artery, and to the petrous portion of the internal carotid artery. The flexible elongate body can have an insert length that is at least about 49 cm to allow for positioning the material transition proximal to the brachiocephalic take-off in the aortic arch.The total functional length of the device required to span from an external access point (e.g., femoral artery) to the target intracranial treatment site.

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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US11806032

Application Number
US18067666A
Filing Date
Dec 16, 2022
Publication Date
Nov 7, 2023
External Links
Slate, USPTO , Google Patents