Methods for delivery of therapeutic materials to treat cancer

Abstract

Disclosed is a localized method for treatment of cancer including the steps of providing a drug delivery catheter; navigating the catheter to the bile duct; and delivering a therapeutic agent into the bile duct. According to one aspect of the method, the drug delivery catheter is a multi-occlusion balloon catheter. The multi-occlusion balloon catheter may include at least two balloons. The multi-occlusion balloon catheter may optionally include a pressure transducer between the balloons to optimize delivery technique.

1 . (canceled) 
     
     
         2 . An apparatus, comprising:
 an inner catheter defining an inner catheter lumen configured to receive a guidewire;   an outer catheter defining a first lumen configured to introduce a therapeutic material to one or more target vessels, and a second lumen configured to slidably receive at least a portion of the inner catheter;   a first occluder coupled to the inner catheter;   a second occluder coupled to the outer catheter, the second occluder disposed proximal to the first occluder, a distance between the first occluder and the second occluder being adjustable; and   a pressure transducer configured to detect a pressure within the target vessel between the first occluder and the second occluder.   
     
     
         3 . The apparatus of  claim 2 , further comprising a seal coupled to the outer catheter and configured to prevent the therapeutic material from entering the second lumen of the outer catheter. 
     
     
         4 . The apparatus of  claim 2 , wherein the first occluder includes one of an expandable filter and an inflatable balloon. 
     
     
         5 . The apparatus of  claim 2 , wherein the first occluder and the second occluder define an isolated region of a targeted vessel, the first lumen of the outer catheter is configured to allow atraumatic introduction of therapeutic cells into the isolated region. 
     
     
         6 . The apparatus of  claim 2 , wherein the first lumen of the outer catheter is configured to allow rapid infusion of the therapeutic material. 
     
     
         7 . The apparatus of  claim 3 , wherein a distance between the first occluder and the seal can be adjusted. 
     
     
         8 . The apparatus of  claim 3 , wherein the second occluder and the seal collectively have a diameter between 2 mm and 12 mm. 
     
     
         9 . The apparatus of  claim 2 , wherein the therapeutic material includes stem cells. 
     
     
         10 . The apparatus of  claim 2 , further comprising an adapter coupled to the outer catheter, the adapter including a first port and a second port, the first port in fluid communication with the first lumen through which the therapeutic agent can be conveyed to a region of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen. 
     
     
         11 . The apparatus of  claim 2 , wherein the distance between the first occluder and the second occluder is adjustable between 3 cm and 15 cm. 
     
     
         12 . An apparatus comprising:
 an inner catheter defining an inner catheter lumen configured to receive a guidewire;   a first occluder coupled to the inner catheter at a first axial location along the catheter device;   an outer catheter including a side wall defining an infusion aperture, the outer catheter defining a first lumen in fluid communication with the infusion aperture and a second lumen, at least a portion of the inner catheter being slidably disposed within the second lumen;   a second occluder coupled to the outer catheter at a second axial location along the catheter device, the second axial location spaced apart from the first axial location such that the infusion aperture is between the first occluder and the second occluder, the first occluder and the second occluder being configured to isolate a segment of a vessel; and   an adapter coupled to the outer catheter, the adapter including a first port and a second port, the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a segment of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen.   
     
     
         13 . The apparatus of  claim 12 , wherein the second axial location is spaced apart from the first axial location by a distance of between 3 cm and 15 cm. 
     
     
         14 . The apparatus of  claim 12 , further comprising a pressure sensor disposed between the first occluder and the second occluder, the pressure sensor configured to measure a fluid pressure within the segment of the vessel isolated by the first occluder and the second occluder. 
     
     
         15 . The apparatus of  claim 12 , further comprising a seal coupled to the outer catheter between the inner catheter and the outer catheter, the seal configured to prevent the therapeutic agent from entering the second lumen of the outer catheter. 
     
     
         16 . The apparatus of  claim 12 , wherein the first occluder and the second occluder are each configured to be transitioned from a collapsed configuration to an expanded configuration, the first occluder and the second occluder isolating the segment of the vessel when each of the first occluder and the second occluder are in their expanded configuration. 
     
     
         17 . The apparatus of  claim 12 , wherein the adapter includes a third port fluidically coupled to the second occluder, the second port configured to convey an inflation medium to the second occluder to transition the second occluder from its collapsed configuration to its expanded configuration. 
     
     
         18 . The apparatus of  claim 12 , further comprising a pressure monitoring port in line with the infusion aperture and through which an infusion pressure within the isolated segment of the vessel between the first occluder and the second occluder can be measured. 
     
     
         19 . The apparatus of  claim 12 , wherein the distance between the first occluder and the second occluder is adjustable. 
     
     
         20 . An apparatus comprising:
 an inner catheter defining an inner catheter lumen configured to receive a guidewire;   a first occluder coupled to the inner catheter at a first axial location along the catheter device;   an outer catheter including a side wall defining an infusion aperture, the outer catheter defining a first lumen in fluid communication with the infusion aperture and a second lumen, at least a portion of the inner catheter being slidably disposed within the second lumen;   a second occluder coupled to the outer catheter at a second axial location along the catheter device, the second axial location spaced apart from the first axial location such that the infusion aperture is between the first occluder and the second occluder, the first occluder and the second occluder being configured to isolate a segment of a vessel, wherein the distance between the first occluder and the second occluder is adjustable;   an adapter coupled to the outer catheter, the adapter including a first port and a second port, the first port in fluid communication with the first lumen through which a therapeutic agent can be conveyed to a segment of the vessel isolated by the first occluder and the second occluder, the second port in fluid communication with the second lumen; and   a pressure transducer configured to detect a pressure within the target vessel between the first occluder and the second occluder.