Catheter systems with a blocking mechanism and methods for bypassing an occlusion in a blood vessel

Inventors

Sina, Achille

Assignees

Invatec SpA

Abstract

A catheter for use with a subintimal reentry guidewire includes a proximal portion having a proximal guidewire lumen and a proximal inflation lumen, a distal portion having a distal guidewire lumen and a distal inflation lumen, and an intermediate portion disposed between the proximal portion and the distal portion and having an intermediate inflation lumen in fluid communication with the proximal and distal inflation lumens. The intermediate portion is devoid of a guidewire lumen. A blocking mechanism disposed in the distal portion of the catheter is transformable from a non-blocking configuration in which a guidewire is free to translate through the distal guidewire lumen and a blocking configuration in which a guidewire disposed in the distal guidewire lumen is prevented from translating through the distal guidewire lumen.

Core Innovation

The invention relates to bypassing an occlusion in a true lumen of a blood vessel by forming a loop of a guidewire within a subintimal space and advancing a catheter over the guidewire so the catheter assumes a generally looped configuration conforming to the loop of the guidewire. The method advances a guidewire into a subintimal space between layers of the blood vessel wall proximal to the occlusion such that a distal end of the guidewire is directed back proximally, thereby forming a loop in the guidewire in the subintimal space.

The catheter construction includes a proximal portion and a distal portion configured with guidewire lumens and inflation lumens, and an intermediate portion disposed between the proximal portion and the distal portion. The intermediate portion has a mono-lumen construction including an intermediate inflation lumen in fluid communication with the distal inflation lumen and the proximal inflation lumen, or includes an intermediate lumen in communication with a first distal lumen and the first proximal lumen.

A blocking mechanism is used to prevent a distal portion of the guidewire disposed in the distal guidewire lumen, or second distal lumen, from translating within the distal guidewire lumen. The blocking mechanism is activated to prevent distal translation while allowing the loop formed in the guidewire to advance distally when pushing the guidewire such that the distal end of the guidewire does not advance and the loop advances distally. In dependent refinement, a loop perforates into the wall and enters the true lumen distal of the occlusion, with optional stent placement across the subintimal conduit for fluid flow restoration.

Claims Coverage

The partial content provides two independent methods that share the same core loop-forming and loop-advancing concept, with independent claim differences centered on the catheter lumen architecture and the specific lumen arrangement used while preventing distal guidewire translation. The independent claims are supported by dependent refinements that add blocking-mechanism embodiments, perforation into the true lumen distal of the occlusion, and additional stent-related steps.

Across the two independent claims, the inventive concept is to create and advance a subintimal guidewire loop while using catheter lumen arrangements and a blocking mechanism to prevent distal translation of the guidewire in a distal guidewire lumen, thereby enabling distal advancement of the loop and, in dependent refinements, perforation into the true lumen distal of the occlusion.

Stated Advantages

Documented Applications