Apparatus and method for promoting angiogenesis in ischemic tissue

Abstract

A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen; an expandable member disposed in the distal region, the expandable member configured to support a subintimal space in an occluded blood vessel of a patient, and to transition between a collapsed state and an expanded state; and a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, and into tissue surrounding the occluded blood vessel, wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel. Methods of using the inventive biologics delivery device also are provided to deposit the biologic from a subintimal space to tissue surrounding the occluded blood vessel.

1 . A biologics delivery device for delivering a biologic to tissue surrounding an occluded blood vessel of a patient, comprising:
 a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen;   an expandable member disposed in the distal region, the expandable member configured to support a space in the occluded blood vessel, and to transition between a collapsed state and an expanded state; and   a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, through the expandable member, and into the tissue,   wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel.   
     
     
         2 . The biologics delivery device of  claim 1 , further comprising a side opening formed through the side wall and disposed on the distal region, wherein the hollow needle is deployed through the side opening. 
     
     
         3 . The biologics delivery device of  claim 2 , wherein the catheter lumen terminates at the side opening. 
     
     
         4 . The biologics delivery device of  claim 1 , further comprising an actuator configured to transition the expandable member between the collapsed state and the expanded state, the actuator further configured to maintain the expandable member in the expanded state during the delivery of the biologic. 
     
     
         5 . The biologics delivery device of  claim 4 , wherein the actuator comprises a sheath. 
     
     
         6 . The biologics delivery device of  claim 1 , wherein the hollow needle is configured to be advanced through the expandable member in the expanded state. 
     
     
         7 . The biologics delivery device of  claim 1 , wherein the hollow needle is formed of nitinol. 
     
     
         8 . The biologics delivery device of  claim 1 , further comprising at least one radiopaque marker. 
     
     
         9 . The biologics delivery device of  claim 1 , wherein the expandable member comprises a plurality of strands. 
     
     
         10 . The biologics delivery device of  claim 1 , wherein the expandable member comprises a mesh-like structure. 
     
     
         11 . The biologics delivery device of  claim 1 , wherein the biologic comprises one or more hematopoietic stem cells, endothelial progenitor cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells, growth factors, or any combination thereof. 
     
     
         12 - 20 . (canceled)