Catheter Assembly For Blood Clots Removal

Patent No. US11096703 (titled "Catheter Assembly For Blood Clots Removal") was filed by Anoxia Medical Inc on May 16, 2019.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical landscape at the time

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.

Novelty and Inventive Step

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Catheter wall
(Claim 1)
“In yet another aspect of the present invention, an endovascular catheter includes an elongate flexible catheter body having a proximal end, a distal end and a side wall defining a central lumen. The side wall includes a tubular inner liner and a hybrid reinforcement that includes a helical coil and a braid. An outer jacket encloses the hybrid reinforcement and is formed from a plurality of tubular segments positioned end to end, coaxially along the hybrid reinforcement.”The wall of the catheter body, comprising an inner liner, a hybrid reinforcement, and a variable outer jacket.
Distal tip
(Claim 1)
“Currently used air aspiration pumps are reaching almost an absolute vacuum of approximately 29 in-Hg (>14 psi) while aspirating air from a blood collection container with a maximum liquid negative pressure of around 27.0 in-Hg. Use of liquid pumps may be beneficial and may increase direct blood aspiration to 28+ in-Hg. Another option is to increase the size (e.g., inner lumen) of the aspiration catheters. Increasing the size of the inner lumen of an aspiration catheter while maintaining the same diameter for the outer lumen is challenging because this compromises the required performance characteristics for the catheter, such as, for example, kink resistance.”A tip located at the distal end of the catheter, extending beyond the radiopaque marker.
Hybrid reinforcement
(Claim 1)
“In yet another aspect of the present invention, an endovascular catheter includes an elongate flexible catheter body having a proximal end, a distal end and a side wall defining a central lumen. The side wall includes a tubular inner liner and a hybrid reinforcement that includes a helical coil and a braid. An outer jacket encloses the hybrid reinforcement and is formed from a plurality of tubular segments positioned end to end, coaxially along the hybrid reinforcement.”A reinforcement structure within the catheter wall comprising both a helical coil and a braid that encircles the helical coil.
Inner liner
(Claim 1)
“In yet another aspect of the present invention, an endovascular catheter includes an elongate flexible catheter body having a proximal end, a distal end and a side wall defining a central lumen. The side wall includes a tubular inner liner and a hybrid reinforcement that includes a helical coil and a braid. In accordance with another aspect of the present invention, the inner liner may be formed by dip coating with a removable mandrel or it may be made from PTFE.”A tubular liner forming part of the catheter wall.
Radiopaque marker
(Claim 1)
“After the guide catheter or sheath is placed inside the body, a 0.025″-0.038″ guidewire is removed and a smaller guidewire in sizes between 0.008″-0.018″ is placed at the treatment location. All these activities are performed under fluoroscopy or using other imaging techniques.”A marker positioned on the distal end of the catheter body about the outer circumference of the hybrid reinforcement, used for visualization under fluoroscopy or other imaging techniques.

Patent Family

Patent Family

File Wrapper

The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents

US11096703

ANOXIA MEDICAL INC
Application Number
US16413935
Filing Date
May 16, 2019
Status
Granted
Expiry Date
Jul 14, 2037
External Links
Slate, USPTO, Google Patents