Needle array assembly and method for delivering therapeutic agents

Abstract

A fluid delivery device includes an array of needles, each in fluid communication with a respective reservoir. Respective actuators are coupled so as to be operable to drive fluid from the reservoirs via needle ports. Each needle can have a plurality of ports, and the ports can be arranged to deliver a substantially equal amount of fluid at any given location along its length. A driver is coupled to the actuators to selectively control the rate, volume, and direction of flow of liquid through the needles. The device can simultaneously deliver a plurality of fluid agents along respective axes in solid tissue in vivo. If thereafter resected, the tissue can be sectioned for evaluation of an effect of each agent on the tissue, and based on the evaluation, candidate agents selected or deselected for clinical trials or therapy, and subjects selected or deselected for clinical trials or therapeutic treatment.

1 .- 121 . (canceled) 
     
     
         122 . A device for delivering substances to tissues of a patient comprising: a) one or more chambers having a proximal end and a distal end; and b) a reservoir within the one or more chambers, wherein the reservoir is configured for local delivery of a microdose amount of a substance to a target tissue. 
     
     
         123 .- 137 . (canceled) 
     
     
         138 . The device of claim  126  wherein said device includes multiple microneedles. 
     
     
         139 . (canceled) 
     
     
         140 . The device of  claim 138  wherein said microneedles are configured to collect a volume of capillary blood selected from the group consisting of: 0.01 to about 1.0 microliter, about 0.05 to about 0.5 microliters, or about 0.1 to about 0.3 microliters. 
     
     
         141 . (canceled) 
     
     
         142 . The device of  claim 141  wherein said penetration is performed on demand. 
     
     
         143 . The device of  claim 142  wherein the penetrating member includes a penetrating tip. 
     
     
         144 . The device of  claim 143  comprising multiple penetrating members wherein said penetrating tips are configured to lie in a single plane after skin penetration. 
     
     
         145 . The device of  claim 143  comprising multiple penetrating members wherein said penetrating tips are configured to lie in multiple planes after skin penetration. 
     
     
         146 . The device of  claim 142  wherein the penetrating members have a curved or straight geometry. 
     
     
         147 . The device of  claim 146  comprising multiple penetrating members wherein a first penetrating member has a curved geometry and a second penetrating member has a straight geometry. 
     
     
         148 . The device of  claim 141  wherein a portion of said penetrating member is configured to be placed within a tumor. 
     
     
         149 . (canceled) 
     
     
         150 . The device of  claim 122  wherein said device is configured to provide a patient tissue imaging function. 
     
     
         151 . The device of  claim 150  wherein said device includes a contrast agent selected from the group consisting of: barium sulfate; iodinated contrast agents such as diatrizoate, metrizoate, ioxaglate, iopamidol, iohexal, ioxilan, iopromide, and iodixanol, water, gadolinium and iron oxide; fluorescent imaging agents; analyte specific activatable contrast agents; and combinations thereof. 
     
     
         152 . The device of  claim 122  wherein the substance comprises multiple agents. 
     
     
         153 .- 158 . (canceled) 
     
     
         159 . The device of claim  158  wherein the contrast agent is a computed tomography contrast agent, a magnetic resonance imaging contrast agent, an ultrasound contrast agent, or an x-ray contrast agent. 
     
     
         160 . The device of  claim 122  wherein the substance is in a form selected from the group consisting of: liquid; solution; gel; film; layer; particulate; and combinations thereof. 
     
     
         161 . The device of  claim 122  wherein the substance is variously released. 
     
     
         162 . The device of  claim 122  wherein the substance is configured in a matrix formed of a biodegradable matrix or a matrix which release the substance by diffusion out of or degradation of the matrix. 
     
     
         163 . The device of  claim 162  wherein the substance is homogeneously or heterogeneously distributed within the matrix. 
     
     
         164 . The device of  claim 162  wherein the matrix is biodegradable, nonbiodegradable, or includes both biodegradable and nonbiodegradable portions. 
     
     
         165 . The device of  claim 162  wherein the matrix is selected form the group consisting of: polymer and polymeric matrices; non-polymeric matrices; inorganic and organic excipients and diluents such as calcium carbonate and sugar; and combinations thereof. 
     
     
         166 .- 462 . (canceled)