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

• US 8,821,476 B2
• Filed: 12/02/2010
• Issued: 09/02/2014
• Est. Priority Date: 12/02/2009
• Status: Active Grant

• Current Assignee: RenovoRx
• Original Assignee: RenovoRx
• Inventors: Agah, Ramtin, Najmabadi, Kamran
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/958,711
• Publication Number:
  US 20110295114A1
• Time in Patent Office: 1,370 Days
• Field of Search: 604/500, 604507-510, 604/522, 604/96.01, 604/101.01, 604/101.02, 604/101.03, 604/101.04, 604/101.05, 604/103.01, 604/102.03, 604/103.03, 604/264, 604/915, 604/916, 604/917, 604/919, 600433-435
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

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.

Claims

1. A method, comprising:

introducing a catheter device into a splenic artery, the catheter device including an inner catheter, a first expandable occlusion element coupled to the inner catheter, an outer catheter defining a first lumen configured to introduce a therapeutic agent to one or more target pancreatic arteries, 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,

advancing the catheter device to a target pancreatic portion of the splenic artery;

selectively isolating a region of the target pancreatic portion of the splenic artery;

confirming isolation of at least one of a pancreatic magnum artery and a dorsal pancreatic artery; and

injecting the therapeutic agent into the isolated region.

2. The method of claim 1, further comprising:

advancing at least a portion of the catheter device to an ostium of a celiac artery, a hepatic branch of the celiac artery or a superior mesenteric artery.

3. The method of claim 1, further comprising:

injecting a contrast dye into the isolated region.

4. The method of claim 1, wherein the therapeutic agent includes stem cells.

5. A method, comprising:

introducing a catheter device into a splenic artery, the catheter device including an inner catheter, a first expandable occlusion element coupled to the inner catheter, an outer catheter defining a first lumen configured to introduce a therapeutic agent to one or more target pancreatic arteries, 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,

advancing the catheter device to a target pancreatic portion of the splenic artery;

selectively isolating a region of the target pancreatic portion of the splenic artery;

injecting the therapeutic agent into the isolated region; and

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.

6. The method of claim 5, further comprising:

advancing at least a portion of the catheter device to an ostium of a celiac artery, a hepatic branch of the celiac artery or a superior mesenteric artery.

7. The method of claim 5, further comprising:

injecting a contrast dye into the isolated region.

8. The method of claim 5, wherein the therapeutic agent includes stem cells.