Apparatus and Method for Infusing an Immunotherapy Agent to a Solid Tumor for Treatment

Abstract

An immunotherapy delivery device is provided including a catheter and a pressure modulating device fixed adjacent the distal end of the catheter. In accord with aspects of the device, the lumen of the catheter is coated to facilitate delivery of a healthy immunotherapy agent. A method for delivering an immunotherapy agent to a tumor includes advancing the delivery device into a vessel of a patient, and infusing the agent under pressure into the vessel to penetrate the tumor. The delivery device prevents reflux of the agent toward non-treatment sites.

What is claimed is: 
     
         1 . An apparatus for infusion of an immunotherapy agent into a patient, comprising:
 a) a flexible catheter having a proximal end and a distal end, an agent delivery lumen extending through the catheter and opening to a distal orifice, the agent delivery lumen including at least one of a coating or structure that is hydrophilic, oleophobic, hydrophobic, or at least reduces flow along the lumen of the catheter; and   b) an expandable fluid pressure modulating structure fixed adjacent the distal end of the catheter.   
     
     
         2 . The apparatus according to  claim 1 , wherein the lumen includes both of a structure and a coating that are at least one of hydrophilic, hydrophobic, or at least reduces flow along the lumen of the catheter. 
     
     
         3 . The apparatus according to  claim 1 , wherein the structure is an oleophobic and/or a hydrophobic surface geometry. 
     
     
         4 . The apparatus according to  claim 1 , wherein the catheter carries a negative charge during use. 
     
     
         5 . The apparatus according to  claim 4 , wherein the catheter carries a zero current or a negligible current during use. 
     
     
         6 . The apparatus according to  claim 1 , further comprising the immunotherapy agent, wherein at least one of the lumen and the agent are provided with a surfactant. 
     
     
         7 . The apparatus according to  claim 1 , where the coating includes a hydrogel that acts (i) to inhibit T-cell attachment, (ii) to inhibit T-cell activation, or (iii) as a protectants against fluid-mechanical T-cell damage. 
     
     
         8 . An apparatus for infusion of an immunotherapy agent into a patient, comprising:
 a) a flexible outer catheter having a proximal end and a distal end;   b) a flexible inner catheter having a proximal end and a distal end, a lumen extending through the inner catheter and opening to a distal orifice, the inner catheter extending through and longitudinally displaceable relative to the outer catheter, the lumen coated with at least one of,
 i) a first coating including cytokines, and 
 ii) a second coating including at least one of a hydrophilic coating, a hydrophobic coating, and a coating layer that at least reduces flow along the lumen of the catheter; and 
   c) a filter valve having a proximal end and distal end, the proximal end of the filter valve coupled to the distal end of the inner catheter such that the orifice of the inner catheters opens into the proximal end of the filter valve, wherein longitudinal displacement of the inner catheter relative to the outer catheter moves the filter valve from a non-deployed configuration to a deployed configuration, the filter valve having a proximal portion comprising a braided filamentary structure that is adapted to dynamically open and close based on the relatively proximal and distal fluid pressure conditions to which the filter is subject, and at least a portion of the braided filamentary structure including a polymeric filter thereon deposited by electrospinning or electrostatic deposition to bond with the braided filamentary structure, the filter having a pore size not exceeding 500 μm.   
     
     
         9 . An apparatus for infusion of an immunotherapy agent into a patient, comprising:
 a) a flexible catheter having a proximal end and a distal end, a first lumen, and an agent delivery second lumen extending through the catheter and opening to a distal orifice, the second lumen coated with at least one of,
 i) a first coating including cytokines, and 
 ii) a second coating including at least one of a hydrophilic coating, a hydrophobic coating, and a coating layer that at least reduces flow along the lumen of the catheter; and 
   b) a fluid expandable balloon coupled adjacent the distal end of the catheter and in fluid communication with the first lumen.   
     
     
         10 . A method of delivering an immunotherapy agent to a tumor, comprising:
 a) providing an immunotherapy delivery device including,
 i) a flexible catheter having a proximal end and a distal end, an agent delivery lumen extending through the catheter and opening to a distal orifice, the agent delivery lumen coated with at least one of,
 A) a first coating including cytokines, and 
 B) a second coating including at least one of a hydrophilic coating, a hydrophobic coating, and a coating layer that at least reduces flow along the lumen of the catheter, and 
 
 ii) an expandable fluid pressure modulating structure fixed adjacent the distal end of the catheter; 
   b) inserting said device into a vessel; and   c) infusing the immunotherapy agent through the lumen of the catheter, into the vessel and into the tumor.