Injection array apparatus

Abstract

A fluid delivery system for delivering and injecting fluid into heart tissue, or other organ tissues. The fluid delivery system includes an injection catheter disposed in an elongate sheath. A nozzle, including an injection array, is disposed adjacent the distal end of the injection catheter. In a first (microneedle) embodiment, the injection array comprises a plurality of microneedles each defining an injection lumen in fluid communication with the lumen of the catheter. In a second (needle-less) embodiment, the injection array comprises a plurality of injection lumens in fluid communication with the lumen of the catheter. Fluid is transferred to the injection lumen array from a fluid source through the lumen in the catheter. The injection lumen array distributes the fluid at the injection site over a greater area than would otherwise be achieved with a single needle injection. Thus, the injection lumen array improves fluid retention in the tissue at the injection site.

What is claimed is:  
     
         1 . A catheter for delivering a fluid to an injection site in heart tissue, comprising: 
 an elongate tubular member having a proximal end, a distal end, and a lumen extending therethrough;    a nozzle member disposed proximate the distal end of the tubular member; and    a plurality of microneedles connected to the nozzle member, the microneedles defining a plurality of injection lumens in fluid communication with the lumen of the tubular member.    
     
     
         2 . A catheter as in  claim 1 , further comprising an anchor disposed proximate the distal end of the tubular member.  
     
     
         3 . A catheter as in  claim 1 , further comprising an outer sheath having a proximal end, a distal end, and a lumen extending therethrough, the tubular member slidingly disposed in the lumen of the sheath.  
     
     
         4 . A catheter as in  claim 3 , further comprising an anchor disposed proximate the distal end of the sheath.  
     
     
         5 . A catheter as in  claim 1 , wherein each of the microneedles have a diameter in the range of approximately 0.005 to 0.05 inches.  
     
     
         6 . A system for delivering a fluid to an injection site in heart tissue, comprising: 
 a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;    a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member;    a nozzle member disposed proximate the distal end of the second tubular member;    the nozzle member including a plurality of microneedles, each microneedle defining an injection lumen in fluid communication with the lumen of the second tubular member, the lumen of each microneedle terminating with an injection orifice; and    a fluid source in fluid communication with the lumen of the second tubular member.    
     
     
         7 . A system as in  claim 6 , wherein an anchor is disposed proximate the distal end of the second tubular member.  
     
     
         8 . A system as in  claim 6 , wherein an anchor is disposed proximate the distal end of the first tubular member.  
     
     
         9 . A system as in  claim 8 , wherein the anchor comprises a vacuum orifice.  
     
     
         10 . A system as in  claim 9 , wherein the vacuum orifice is in fluid communication with a vacuum source via the lumen of the second tubular member.  
     
     
         11 . A system as in  claim 6 , wherein each of the microneedles have a diameter in the range of approximately 0.005 to 0.05 inches.  
     
     
         12 . A method of delivering a fluid to an injection site in a patient's heart tissue, comprising the steps of: 
 providing a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;    providing a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member, the second tubular member including a nozzle member disposed proximate the distal end thereof, the nozzle member including a plurality of microneedles, each microneedle defining an injection lumen in fluid communication with the lumen of the second tubular member, the lumen of each microneedle terminating with an injection orifice;    inserting the first tubular member into the patient;    advancing the first tubular member until the distal end thereof is proximate the injection site in the patient's heart tissue;    advancing the second tubular member through the first tubular member until the plurality of injection orifices are proximate the injection site;    urging the fluid from the fluid source to the lumen of second tubular member; and    injecting the fluid into the heart tissue at the injection site via the microneedles.    
     
     
         13 . A method of delivering a fluid as in  claim 12 , further including the step of stabilizing the distal end of the first tubular member relative to the target site.  
     
     
         14 . A method of delivering a fluid as in  claim 12 , wherein the microneedles are advanced into the tissue and retained in the tissue for a period of time after the fluid has been injected into the tissue in order to allow the fluid to be absorbed by the tissue.  
     
     
         15 . A method of delivering a fluid as in  claim 14 , wherein the period of time ranges from about 5 seconds to about 120 seconds.  
     
     
         16 . A method of delivering a fluid as in  claim 14 , wherein the period of time ranges from about 5 seconds to about 30 seconds.  
     
     
         17 . A catheter for delivering a fluid to an injection site in heart tissue, comprising: 
 an elongate tubular member having a proximal end, a distal end, and a lumen extending therethrough;    a nozzle member disposed proximate the distal end of the tubular member; and    a plurality of injection lumens defined by the nozzle member, the injection lumens terminating with an injection orifice in fluid communication with the lumen of the tubular member.    
     
     
         18 . A catheter as in  claim 17 , further comprising an outer sheath having a proximal end, a distal end, and a lumen extending therethrough, the tubular member slidingly disposed in the lumen of the sheath.  
     
     
         19 . A catheter as in  claim 18 , further including an anchor disposed proximate the distal end of the sheath.  
     
     
         20 . A catheter as in  claim 19 , wherein the anchor comprises a vacuum orifice defined by the lumen of the sheath adjacent the distal end thereof.  
     
     
         21 . A catheter as in  claim 17 , wherein each of the injection lumens have a diameter in the range of approximately 0.00005 to 0.005 inches.  
     
     
         22 . A system for delivering a fluid to an injection site in heart tissue, comprising: 
 a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;    a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member;    a nozzle member disposed proximate the distal end of the second tubular member;    the nozzle member including a plurality of injection lumens in fluid communication with the lumen of the second tubular member, the injection lumens terminating with an injection orifice; and    a fluid source in fluid communication with the lumen of the second tubular member.    
     
     
         23 . A system as in  claim 22 , wherein an anchor is disposed proximate the distal end of the first tubular member.  
     
     
         24 . A system as in  claim 23 , wherein an anchor is disposed proximate the distal end of the second tubular member.  
     
     
         25 . A system as in  claim 24 , wherein the anchor comprises a vacuum orifice.  
     
     
         26 . A system as in  claim 25 , wherein the vacuum orifice is in fluid communication with a vacuum source via the lumen of the second tubular member.  
     
     
         27 . A system as in  claim 22 , wherein each of the injection lumens have a diameter in the range of approximately 0.00005 to 0.005 inches.  
     
     
         28 . A method of delivering a fluid to an injection site in a patient's heart tissue, comprising the steps of: 
 providing a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;    providing a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member, the second tubular member including a nozzle member disposed proximate the distal end thereof, the nozzle member including a plurality of injection lumens in fluid communication with the lumen of the second tubular member, each injection lumen terminating with an injection orifice;    inserting the first tubular member into the patient;    advancing the first tubular member until the distal end thereof is proximate the injection site in the patient's heart tissue;    advancing the second tubular member through the first tubular member until the plurality of injection orifices are proximate the injection site;    urging the fluid from the fluid source to the lumen of second tubular member; and    injecting the fluid into the heart tissue at the injection site via the injection lumens.    
     
     
         29 . A method as in  claim 25 , further including the step of stabilizing the distal end of the first tubular member relative to the target site.