US 11406402

Summary of US Patent 11406402

Title: Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

Assignee: Rapidpulse Inc and Syntheon Neurovascular LLC

Inventors: Derek Dee Deville, Matthew A. Palmer, William T. Bales, M. Sean McBrayer, Eric Peterson, Richard Cartledge, Thomas O. Bales, Jr., Carlos Rivera

Filing Date: 2022-02-11

Issue Date: 2022-08-09

Abstract (Inferred from Summary Section):
The patent describes an aspiration thrombectomy system and methods for removing thrombi using an aspiration catheter. The system aims to overcome limitations of previous devices by achieving higher first-pass recanalization rates and reducing catheter obstruction. It completely vacuums up clots, preventing them from partially protruding from the catheter tip while being withdrawn. The system moves the aspirated clot to the proximal end of the vacuum channel, allowing surgeons to confirm vessel recanalization (e.g., via contrast injection) and verifying thrombus removal and restored blood flow. This system can also enhance the efficacy of conventional aspiration catheters and pump systems.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a vacuum catheter designed to remove objects (like blood clots) from blood vessels. It has a tube with a vacuum channel and a controller that can temporarily stop the vacuum flow and then push a small amount of fluid forward to dislodge a stuck object.
• Claim 5: This claim outlines a clot removal system featuring a catheter, a vacuum valve connected to a vacuum source, and a vent valve connected to a vent liquid source. A central manifold links these to the catheter, and a controller manages the opening and closing of the vacuum and vent valves to control the flow.
• Claim 10: This claim describes a clot removal system that uses a catheter, a vacuum source, a vent liquid source, and a control system. This control system repeatedly connects or disconnects the vacuum and/or vent liquid to the catheter to vary the vacuum level at its tip, while crucially preventing fluid from flowing out of the catheter.
• Claim 13: Similar to Claim 10, this system uses a catheter, vacuum source, and vent liquid source with a control system. It cyclically connects vacuum, vent liquid, or neither, to the catheter's proximal end to alter the vacuum at the distal end, ensuring fluid doesn't flow forward out of the catheter.
• Claim 16: This claim details a clot removal system with a catheter, a vacuum pump, a vent liquid container, and separate vent and vacuum valves. A controller follows a pre-set pattern of opening and closing these valves to change the vacuum level at the catheter's distal end, specifically designed to prevent any forward flow of liquid from the catheter tip during this process.
• Claim 24: This claim describes a clot removal system where a catheter contains specific operating parameters. When the catheter is connected to either the vacuum source or the controller, these parameters are automatically recognized by the controller. The controller then executes a pre-defined pattern of turning the vacuum on and off based on these parameters to adjust the vacuum level at the catheter's distal end.
• Claim 32: This claim describes a clot removal system that includes a catheter with operating parameters, a vacuum source, a vent container, and both vent and vacuum valves. A controller uses the catheter's operating parameters to execute a control pattern for opening and closing the valves. This pattern changes the vacuum level at the catheter's distal end while simultaneously preventing forward flow of liquid, with the operating parameters being automatically received upon connection of the catheter.

Litigation Status:
US Patent 11406402 is involved in litigation. A PTAB case (IPR2024-01261) has been filed and has reached a Final Written Decision. Additionally, a US case related to this patent has been filed in the Court of Appeals for the Federal Circuit (case number 26-1719).## US Patent 11406402: Aspiration Thrombectomy System for Thrombus Removal

Patent Number: US11406402B2
Title: Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter
Assignee: Rapidpulse Inc and Syntheon Neurovascular LLC
Inventors: Derek Dee Deville, Matthew A. Palmer, William T. Bales, M. Sean McBrayer, Eric Peterson, Richard Cartledge, Thomas O. Bales, Jr., Carlos Rivera
Filing Date: 2022-02-11
Issue Date: 2022-08-09

Abstract:
The described aspiration thrombectomy system and methods aim to improve thrombus removal using an aspiration catheter. The system is designed to increase first-pass recanalization rates by fully aspirating emboli, thereby reducing catheter obstruction. It completely vacuums clots into the catheter, preventing them from being dragged out while partially protruding. The system ensures the clot travels to the proximal end of the vacuum channel, allowing surgeons to confirm vessel recanalization (e.g., by injecting contrast) and verify thrombus removal and restored blood flow. This technology can also be integrated with existing aspiration catheters and pump systems to enhance their performance.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a vacuum catheter for removing objects, such as blood clots, from human blood vessels. It features a vacuum tube with openings at both ends and a unique "vacuum interruption controller" located in the middle. This controller has a mechanism (an extrusion compressor) that can first block the vacuum channel and then push any fluid trapped between the controller and the catheter's tip a specific distance distally to dislodge the object.

• Claim 5: This claim defines a clot removal system that includes a catheter with a fluid-filled channel, a controllable vacuum valve connected to a vacuum source, and a controllable vent valve connected to a source of vent liquid. These components are linked to the catheter via a manifold. A controller electronically or mechanically operates the vacuum and vent valves to selectively connect either the vacuum or the vent liquid to the catheter's fluid column.

• Claim 10: This claim covers a clot removal system comprising a catheter, a vacuum source, a vent liquid source, and a vacuum and vent control system. The control system is configured to repeatedly switch the connection between the vacuum source and the vent liquid source to the catheter. This action changes the vacuum level at the catheter's tip in a cyclic manner, while importantly preventing fluid from flowing forward (out of the catheter) during the process.

• Claim 13: This claim outlines a clot removal system similar to claim 10. It specifies a control system that cyclically connects to the catheter's proximal end either vacuum, vent liquid, or neither, thereby changing the vacuum level at the distal end. The key function is to prevent forward flow of the liquid in the catheter.

• Claim 16: This claim describes a clot removal system that uses a catheter, a vacuum pump, a vent liquid container, and specific vent and vacuum valves. A controller is programmed to execute a pre-determined sequence of opening and closing these valves. This sequence is designed to modulate the vacuum level at the catheter's distal end and, at the same time, ensure that liquid does not flow forward out of the catheter's tip.

• Claim 24: This claim details a clot removal system where the catheter itself stores its optimal operating parameters. When the catheter is connected to the vacuum source or the system controller, these parameters are automatically transferred. The controller then uses these parameters to perform a specific sequence of turning the vacuum on and off, adjusting the vacuum level at the catheter's distal end.

• Claim 32: This claim describes a clot removal system with a catheter that contains specific operating parameters. It also includes a vacuum source, a vent liquid container, and both vent and vacuum valves. A controller operates these valves based on the catheter's parameters, which are automatically received upon connection. The controller's function is to change the vacuum level at the catheter's distal end while simultaneously preventing any forward flow of liquid from the catheter.

Litigation Status:
US Patent 11406402 is currently involved in litigation. A Post-Grant Review (IPR2024-01261) case was filed with the Patent Trial and Appeal Board (PTAB) and has reached a Final Written Decision. Additionally, a case concerning this patent has been filed in the US Court of Appeals for the Federal Circuit, identified by case number 26-1719.