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

Inventors

Agah, Ramtin • Najmabadi, Kamran

Assignees

RenovoRx Inc

Abstract

Devices and methods are described herein for engraftment of stem cells into a pancreas using an endovascular approach. Targeted intra-arterial injection of stem cells selectively in a splenic artery can achieve engraftment of insulin producing cells in the tail of the pancreas with high efficiency and without systemic circulation of these cells to other organs. In one embodiment, a catheter device includes expandable occlusion elements in the form of inflatable balloons that can be used to isolate a proximal and distal end of a pancreatic portion of the splenic artery. In another embodiment, the occlusion elements include a filter element instead of a balloon. In some embodiments, targeted delivery of stem cells to the pancreatic tail can be achieved for treatment of, for example, diabetes. In some embodiments, an arterial section of the splenic artery can be isolated for selective perfusion of therapeutic cells/drugs to the tail of the pancreas.

Core Innovation

The invention provides endovascular pancreatic therapy that targets the splenic artery for selective engraftment and local drug delivery. A catheter device is introduced into a splenic artery and advanced to a target pancreatic portion of the splenic artery, where a region of the target pancreatic portion is selectively isolated. The isolation is used to enable delivery of a therapeutic agent to one or more target pancreatic arteries while maintaining the region as an isolated delivery zone.

The catheter device includes an inner catheter, a first expandable occlusion element coupled to the inner catheter, and an outer catheter defining a first lumen to introduce a therapeutic agent to one or more target pancreatic arteries. The catheter device further includes a second lumen configured to slidably receive at least a portion of the inner catheter, and a second expandable occlusion element coupled to the outer catheter and disposed proximally to the first occlusion element. This arrangement supports selective isolation of a region of the target pancreatic portion of the splenic artery.

The method confirms isolation of at least one of a pancreatic magnum artery and a dorsal pancreatic artery and then injects the therapeutic agent into the isolated region. In some embodiments, the method includes inserting a guidewire through the first lumen of the outer catheter and focally perforating the splenic artery in the isolated region to increase exogenous cell penetration into pancreatic tissue. The approach is described for delivery of stem cells and for localized intra-arterial chemotherapy directed to pancreatic tissue.

Claims Coverage

Two independent method claims are identified. Each claim centers on introducing a catheter device into a splenic artery, selectively isolating a region of a target pancreatic portion, and delivering a therapeutic agent into that isolated region, with one claim further adding guidewire-based focal perforation to increase exogenous cell penetration.

Across the independent claims, the inventive coverage is directed to catheter device structures with first and second expandable occlusion elements for selectively isolating a region of the target pancreatic portion of the splenic artery, followed by injection of a therapeutic agent into the isolated region, with one claim requiring confirmation of pancreatic magnum and dorsal pancreatic artery isolation and the other adding guidewire insertion and focal perforation.

Stated Advantages

Documented Applications