Patent No. US11096703 (titled "Catheter Assembly For Blood Clots Removal") was filed by Anoxia Medical Inc on May 16, 2019.
’703 is related to the field of medical devices, specifically endovascular catheters used for removing thromboembolic materials from the human body. The background highlights the challenges of aspirating clots, particularly harder, more organized clots that tend to clog catheters, leading to potential distal embolization and clinical complications. Existing aspiration techniques often fall short of achieving complete recanalization, creating a need for improved devices that are simple, safe, and effective in removing thromboembolic material.
The underlying idea behind ’703 is to enhance the performance of endovascular catheters by optimizing the catheter wall structure. This is achieved through a hybrid reinforcement combining a helical coil and a braid, along with a variable durometer outer jacket. The combination aims to improve pushability, flexibility, and kink resistance while maintaining a large inner lumen for effective aspiration. The design addresses the problem of catheter compression during percutaneous procedures, which can limit aspiration and overall performance.
The claims of ’703 focus on an endovascular catheter with a specific construction. It covers an elongate flexible catheter body with a central lumen, a catheter wall comprising an inner liner, the hybrid reinforcement (helical coil and braid) , and a variable outer jacket. A radiopaque marker is positioned on the distal end, bonded to the hybrid reinforcement. Crucially, the claim specifies a thickness ratio of the inner diameter to the outer diameter of 0.80 or higher, indicating a design that maximizes the lumen size relative to the overall catheter size.
In practice, the catheter's hybrid reinforcement provides a balance of strength and flexibility. The helical coil contributes to kink resistance and radial support, while the braid enhances torsional stiffness and pushability. The variable durometer outer jacket allows for a tailored flexibility profile, with a softer distal tip for atraumatic navigation and a stiffer proximal section for improved control. The radiopaque marker enables precise positioning under fluoroscopy, and the high inner-to-outer diameter ratio ensures efficient aspiration of clots.
The differentiation from prior approaches lies in the specific combination of the hybrid reinforcement and the controlled flexibility profile achieved through the variable durometer outer jacket. Traditional catheters may rely on single-layer reinforcements or uniform material properties, which can compromise either pushability, flexibility, or lumen size. By carefully selecting materials and combining a helical coil and braid, ’703 achieves a superior balance of these characteristics, leading to improved clot retrieval rates and reduced risk of complications compared to existing aspiration catheters.
In the mid-2010s when ’703 was filed, endovascular procedures commonly relied on guidewires and catheters to navigate to treatment sites within the body. At a time when aspiration thrombectomy was typically implemented using single-lumen catheters, increasing the inner lumen size of aspiration catheters while maintaining kink resistance was non-trivial. When systems commonly relied on vacuum pumps to aid in aspiration, there was a need for better aspiration devices which are simple to use, and can quickly and safely remove thromboembolic material.
The examiner allowed the claims because the prior art, whether taken alone or in combination, does not teach or render obvious a catheter that includes a hybrid reinforcement comprising a helical coil and a braid that encircles the helical coil, along with a radiopaque marker positioned on the distal end of the catheter body about the outer circumference of the hybrid reinforcement. The distal ends of the helical coil and braid are terminated between the distal and proximal ends of the radiopaque marker, and the radiopaque marker is bonded to the distal end of the hybrid reinforcement, with a distal tip extending distally beyond the radiopaque marker.
This patent contains 6 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to an endovascular catheter with a specific hybrid reinforcement and radiopaque marker configuration. The dependent claims 2-6 further define and limit the features of the catheter described in independent claim 1.
Definitions of key terms used in the patent claims.

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