Method and system for treating aneurysms

Inventors

Schreck, Stefan • Fox, Jason

Assignees

Endologix LLC

Abstract

Methods for treatment of aneurysms using a sequential manifold console to deploy multiple filling structures are provided herein. In one aspect, aneurysms are treated by simultaneously filling two double-walled filling structure using a sequential manifold console to guide a user in the steps to be followed in the procedure and to reliably achieve a consistent and durable aneurysmal treatment using a curable medium. The structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Pairs of filling structures delivered to the aneurysm from different access openings of a patient can be simultaneously prepared and pressurized from a single treatment console when treating abdominal aortic aneurysms using the described systems and methods.

Core Innovation

The invention provides a method of treating an aneurysm using a first catheter and a second catheter, each catheter having an expandable endobag with a double-walled filling structure. The expandable endobag comprises an aneurysm conforming outer wall and a blood transit lumen that creates an inner wall surrounding an endoframe releasably coupled to the catheter, and the endobag is covered in an unexpanded configuration by a retractable sheath.

After removing the sheath, the endobag and expanding endoframe of each catheter are expanded to traverse and position across the aneurysm. The method establishes communication between the fill line for the expandable endobag of the first catheter and the fill line for the expandable endobag of the second catheter with a curable filler material source to form an endobag filler circuit, and one endobag is pre-filled with saline or contrast media so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a blood flow path across the aneurysm.

Contrast media is released after the pre-filling and fluoroscopy is used to image the flow of the contrast media to detect endoleaks around the pre-filled endobag. The method adjusts a filling pressure or volume until no endoleaks are observed during fluoroscopy, records the filling pressure and/or volume at which no endoleaks are observed, and uses one source of curable filler material while pressure within the endobag filler circuit is monitored and controlled so that the expandable endobags inflate, fill the aneurysm, and press against each other and the aneurysmal wall.

Claims Coverage

The partial content includes two independent method claims, each describing a different deployment architecture and workflow for aneurysm treatment. Across the independent claims, the coverage centers on double-walled, aneurysm-conforming endobags with blood transit lumens, pre-filling and fluoroscopic endoleak detection, and pressure/volume-controlled filling using curable or hardenable fluid while imaging and monitoring during deployment.

Across the independent claims, the main inventive elements combine double-walled endobags that create a substantially tubular blood flow path, a pre-filling and fluoroscopy-based detection and elimination of endoleaks via pressure/volume adjustment and recording, and pressure/volume-controlled filling using curable or hardenable fluid, including simultaneous pressurization through a unified endobag filler circuit in the two-catheter approach and inner-shaft delivery with nosecone contrast release and radially expanding endoframe in the inner-shaft approach.

Stated Advantages

Documented Applications