Aspiration Catheter Systems And Methods Of Use

Patent No. US11925770 (titled "Aspiration Catheter Systems And Methods Of Use") was filed by Route 92 Medical Inc on Apr 7, 2023.

What is this patent about?

’770 is related to the field of neurovascular medical devices , specifically aspiration catheter systems used in endovascular procedures to treat acute ischemic stroke (AIS). AIS occurs when an artery to the brain is blocked, typically by a thrombus or embolus, leading to ischemia and potential brain cell death. Current endovascular treatments include mechanical embolectomy and aspiration techniques, often requiring complex, multi-catheter systems that can be challenging to manipulate and time-consuming to deploy.

The underlying idea behind ’770 is to provide a coaxial catheter system that simplifies access to cerebral vessels for aspiration or device delivery, particularly in tortuous anatomies. This is achieved by combining a flexible distal catheter with a less flexible proximal extension, and a catheter advancement element with a tapered tip. The system is designed for single-operator use, enabling rapid access and treatment to restore blood flow to the blocked cerebral vessel.

The claims of ’770 focus on a catheter system with specific bending force characteristics at various points along its length. The system includes a catheter and a catheter advancement element with a tapered tip. The claims define the bending forces at three points on the tapered tip and two system points, and specify a ratio between a flexibility slope calculated from these bending forces that is less than 25. This ratio is intended to ensure a smooth transition in flexibility along the system.

In practice, the invention works by advancing the assembled coaxial system through a guide sheath to the site of the occlusion. The tapered tip of the catheter advancement element facilitates navigation through tortuous vessels, while the specified bending force characteristics ensure that the system is flexible enough to avoid damaging the vessel walls. Once the catheter is in place, the catheter advancement element can be removed, and aspiration can be applied through the catheter lumen to remove the occlusion.

The invention differentiates itself from prior approaches by providing a simplified, single-operator system that can be rapidly deployed. The specific bending force characteristics and the tapered tip design enable the system to navigate complex anatomies without the need for multiple catheters or guidewires. This reduces the risk of complications and improves the efficiency of the procedure, ultimately leading to better outcomes for patients with acute ischemic stroke.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’770 was filed, coaxial catheter systems were commonly used for neurovascular interventions, at a time when achieving rapid access to cerebral vessels and effective aspiration were critical goals. At that time, systems commonly relied on multiple rotating hemostatic valves, and maintaining coaxial relationships between catheters was technically challenging. Hardware constraints made it non-trivial to design catheter systems that offered both flexibility for navigation and sufficient aspiration capability.

Novelty and Inventive Step

The examiner approved the application because the prior art of record did not anticipate or render obvious a catheter system with a specific tapered tip portion and flexibility slope ratio. While the closest prior art (Chou et al., US 2017/0020540) disclosed a catheter system with a tapered tip, it failed to explicitly disclose or suggest the specific flexibility slope relationships defined in the claims, particularly the ratio of the third flexibility slope to the average tip portion flexibility slope being less than about 25.

Claims

This patent contains 10 claims, with independent claims 1 and 6 directed to a catheter system comprising a catheter and a catheter advancement element, focusing on the bending force and flexibility slope characteristics of the tapered tip portion and the overall system. The dependent claims generally add further limitations and specific ratios to the features described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Alignment point
(Claim 1, Claim 6)
“The catheter includes a distal, catheter portion having a lumen and a distal end having an opening from the lumen, the lumen having an inner diameter at the distal end of at least about 0.052″; and a proximal extension coupled to and extending proximally from the distal, catheter portion, the proximal extension being less flexible than the distal, catheter portion. The catheter advancement element includes a tubular portion having an inner diameter that is at least about 0.014″ up to about 0.024″ and an outer diameter having at least one snug point. The coaxial catheter system has an advancement configuration characterized by the catheter advancement element positioned coaxially within the lumen of the distal catheter portion, the at least one snug point of the tubular portion is substantially aligned with the distal end of the distal catheter portion.”A location on the catheter advancement element just proximal to the tapered tip portion. In the assembled configuration, this point is substantially aligned with the distal end of the catheter.
Catheter advancement element
(Claim 1, Claim 6)
“In an aspect described is a coaxial catheter system including a catheter and a catheter advancement element. The catheter advancement element includes a tubular portion having an inner diameter that is at least about 0.014″ up to about 0.024″ and an outer diameter having at least one snug point. The catheter advancement element includes a proximal extension coupled to and extending proximally from the tubular portion, the proximal extension being less flexible than the tubular portion; and a tip portion located distal to the at least one snug point of the tubular portion.”A component of the catheter system that includes a tubular portion and a tapered tip portion. It is positioned within the lumen of the catheter in the assembled configuration.
First flexibility slope
(Claim 1, Claim 6)
“A difference between the second bending force and the first bending force divided by the distance between the distal point and the intermediate point can equal a first flexibility slope. A difference between the third bending force and the second bending force divided by a distance between the intermediate point and the proximal point can equal a second flexibility slope. An average of the first flexibility slope and the second flexibility slope can define an average tip portion flexibility slope. A difference between the first system bending force and the second system bending force divided by the distance between the first system point and the second system point can equal a third flexibility slope.”The rate of change of bending force between the distal point and the intermediate point on the tapered tip portion, calculated as the difference in bending forces divided by the distance between the points.
Tapered tip portion
(Claim 1, Claim 6)
“The catheter advancement element includes a proximal extension coupled to and extending proximally from the tubular portion, the proximal extension being less flexible than the tubular portion; and a tip portion located distal to the at least one snug point of the tubular portion. The tip portion has a length and tapers along at least a portion of the length of the tip portion. The advancement configuration is also characterized by the tip portion in the advancement configuration has at least three points spaced along the length of the tip portion.”A distal part of the catheter advancement element that has at least three points spaced along its length, each point having a specific bending force. The bending forces at these points are used to calculate flexibility slopes.
Third flexibility slope
(Claim 1, Claim 6)
“A difference between the second bending force and the first bending force divided by the distance between the distal point and the intermediate point can equal a first flexibility slope. A difference between the third bending force and the second bending force divided by a distance between the intermediate point and the proximal point can equal a second flexibility slope. An average of the first flexibility slope and the second flexibility slope can define an average tip portion flexibility slope. A difference between the first system bending force and the second system bending force divided by the distance between the first system point and the second system point can equal a third flexibility slope.”The rate of change of bending force between the first system point and the second system point of the catheter system, calculated as the difference in bending forces divided by the distance between the points.

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

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US11925770

ROUTE 92 MEDICAL INC
Application Number
US18297429
Filing Date
Apr 7, 2023
Status
Granted
Expiry Date
May 16, 2039
External Links
Slate, USPTO, Google Patents