Devices, methods and kits for delivery of therapeutic materials to a pancreas

Inventors

Agah, Ramtin • Najmabadi, Kamran • Zanchi, Marta Gaia

Assignees

RenovoRx Inc

Abstract

An apparatus includes an inner catheter that is coupled to a handle and defines a lumen configured to receive a guidewire. An outer catheter is movably coupled to the handle and defines a first lumen in fluid communication with a distal opening and that is configured to introduce a therapeutic agent through the distal opening and into a target pancreatic artery(ies). The outer catheter defines a second lumen configured to receive at least a portion of the inner catheter. An actuator is coupled to the handle and configured to move the outer catheter relative to the handle. A first occlusion element is coupled to the inner catheter and a second occlusion element is coupled to the outer catheter and disposed proximal to the first occlusion element. A distance between the first occlusion element and the second occlusion element is adjustable when the outer catheter is moved relative to the handle.

Core Innovation

The invention relates to an apparatus for endovascular delivery in which an inner catheter and an outer catheter are coaxial and the outer catheter is movably coupled to the inner catheter. The inner catheter defines a guidewire lumen configured to receive a guidewire, and the outer catheter defines a first lumen and a second lumen, with the first lumen defined entirely by a side wall of the outer catheter and in fluid communication with an infusion aperture defined by the side wall proximal to a distal end of the outer catheter.

A first occlusion element is coupled to the inner catheter, and an inflation lumen communicates an inflation medium to the first occlusion element. A second occlusion element is coupled to the outer catheter and disposed proximal to the first occlusion element, with the infusion aperture disposed between the first occlusion element and the second occlusion element. A seal is coupled between the inner catheter and the outer catheter and configured to fluidically isolate the first lumen from the second lumen, such that the first lumen is the only lumen in fluidic communication with a region defined between the occlusion elements.

The invention further describes a sealing arrangement configured to isolate the outer catheter second lumen while a therapeutic agent is introduced directly through the infusion aperture into one or more target vessels or target arteries. The system includes embodiments in which the distance between occlusion elements is adjustable and the infusion aperture lies between the occlusion elements, with occlusion elements described as an expandable filter or an inflatable balloon and sealing element placement preventing therapeutic agent entry into the second lumen.

Claims Coverage

The document provides three independent claims that share the coaxial inner/outer catheter concept with occlusion elements and a sealing element to define an isolated region for infusion through an infusion aperture. Across the independent claims, the inventive features focus on the coaxial catheter lumens and infusion aperture, the occlusion elements and their relative placement, the adjustable versus fixed spacing, and the seal isolating lumen fluidic communication.

Collectively, the independent claims define a coaxial catheter apparatus that uses occlusion elements to define an isolated region and an infusion aperture in the outer catheter to directly introduce a therapeutic agent, while a seal or sealing element fluidically isolates the outer catheter second lumen so delivery is confined to the region between the occlusion elements. The independent claims further differentiate how the occlusion elements are coupled and how spacing between occlusion elements is handled, including adjustable spacing in one independent claim.

Stated Advantages

Documented Applications