Therapeutic delivery devices, systems, and methods

Abstract

Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

What is claimed is: 
     
         1 . A coaxial occlusion/infusion catheter system comprising:
 (i) an occlusion catheter component having an occlusion chamber, wherein the occlusion catheter component provides for occlusion of a vessel or graft distal to an infusion zone;   (ii) an infusion catheter component comprising one or more pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within a thrombus, wherein at least a portion of the occlusion catheter component is coaxially positioned within the infusion catheter component; and   (iii) an outer sheath component having an occlusion chamber, wherein at least a portion of the infusion catheter is coaxially positioned within the outer sheath component, wherein the sheath component provides for the occlusion of the vessel or graft proximal to the infusion zone;   wherein the occlusion chamber of the infusion catheter is activated by inflation through an inflation lumen that is in contact with occlusion chamber of the infusion catheter with a suitable volume of material comprising air, gas, or fluid; and   wherein a composition comprising plasmin can be administered by infusion into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter, and said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus.   
     
     
         2 . The catheter system of  claim 1 , wherein the occlusion chamber is an inflatable balloon. 
     
     
         3 . The catheter system of  claim 1 , wherein the system further comprises an occluding wire configured to substantially or completely seal a distal end of the infusion catheter. 
     
     
         4 . The catheter system of  claim 1 , wherein the thrombus is a peripheral arterial occlusion. 
     
     
         5 . The catheter system of  claim 1 , wherein the infusion zone corresponds to a subject's treatment zone comprising the thrombus mass length within the vessel or graft. 
     
     
         6 . The catheter system of  claim 1 , wherein the infusion zone is maximized. 
     
     
         7 . A coaxial occlusion/infusion catheter system comprising:
 (i) an occlusion catheter component having an occlusion chamber, wherein the occlusion catheter component provides for occlusion of a vessel or graft distal to an infusion zone;   (ii) an infusion catheter component, comprising one or more pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within the thrombus, wherein at least a portion of the occlusion catheter component is coaxially positioned within the infusion catheter component; and   (iii) an outer sheath component wherein at least a portion of the infusion catheter is coaxially positioned within the outer sheath component;   wherein the occlusion chamber of the infusion catheter is activated by inflation through an inflation lumen that is in contact with occlusion chamber of the infusion catheter with a suitable volume of material comprising air, gas, or fluid; and   wherein a composition comprising plasmin can be administered by infusion into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter, and said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus.   
     
     
         8 . The catheter system of  claim 7 , wherein the occlusion catheter's distal tip extends beyond the infusion catheter's distal tip such that the occlusion lies distal to the infusion catheter's distal tip and thereby is capable of occluding a vessel or graft distal to the infusion zone wherein the distal tip of the catheter lies. 
     
     
         9 . The catheter system of  claim 7 , wherein the occlusion chamber is an inflatable balloon. 
     
     
         10 . The catheter system of  claim 7 , wherein the system further comprises an occluding wire configured to substantially or completely seal a distal end of the infusion catheter. 
     
     
         11 . The catheter system of  claim 7 , wherein the thrombus is a peripheral arterial occlusion. 
     
     
         12 . The catheter system of  claim 7 , wherein the infusion zone corresponds to a subject's treatment zone comprising the thrombus mass length within the vessel or graft. 
     
     
         13 . The catheter system of  claim 7 , wherein the infusion zone is maximized. 
     
     
         14 . A coaxial occlusion/infusion catheter system comprising:
 (i) an occlusion wire component; and   (ii) an infusion catheter component comprising one or more pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within a thrombus and having an occlusion chamber, wherein at least a portion of the occlusion wire component is coaxially positioned within the infusion catheter component,   wherein the infusion catheter component provides for occlusion of a vessel or graft distal to an infusion zone;   wherein the occlusion chamber of the infusion catheter is activated by inflation through an inflation lumen that is in contact with occlusion chamber of the infusion catheter with a suitable volume of material comprising air, gas, or fluid; and   wherein a composition comprising plasmin can be administered by infusion into the infusion catheter, and said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus.   
     
     
         15 . The catheter system of  claim 14 , wherein the occlusion chamber is an inflatable balloon. 
     
     
         16 . The catheter system of  claim 14 , wherein the thrombus is a peripheral arterial occlusion. 
     
     
         17 . The catheter system of  claim 14 , wherein the infusion zone corresponds to a subject's treatment zone comprising the thrombus mass length within the vessel or graft. 
     
     
         18 . The catheter system of  claim 14 , wherein the infusion zone is maximized.