Patent No. US11925770 (titled "Aspiration Catheter Systems And Methods Of Use") was filed by Route 92 Medical Inc on Apr 7, 2023.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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