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 . An array, comprising: an array of reservoirs and means for administering a therapeutic or diagnostic agent in tissue immediately adjacent to the administration means and separate from the other administration means. 
     
     
         123 . The array of  claim 122 , further comprising means for separately extracting, sampling or analyzing the tissue or cells at the sites of administration. 
     
     
         124 . The array of  claim 122 , wherein the array provides for separate release of agent in the separate reservoirs. 
     
     
         125 . The array of  claim 122 , wherein each of the reservoirs may be loaded with different substances and/or different microdose amounts of the substances, which can be released independently, optionally further comprising means for controlling release selected from the group consisting of a microprocessor, remote control and a sensor. 
     
     
         126 . The array of  claim 122 , wherein the reservoirs comprise biodegradable polymeric matrices which release agent as a function of diffusion or degradation. 
     
     
         127 . The array of  claim 122  providing microdoses of therapeutic or diagnostic agents. 
     
     
         128 .- 129 . (canceled) 
     
     
         130 . The array of  claim 122 , wherein the means for extracting, sampling or analyzing the tissue or cells are biopsy mechanisms. 
     
     
         131 . (canceled) 
     
     
         132 . The array of  claim 122 , comprising penetrating members. 
     
     
         133 . The array of  claim 122 , comprising an assay component configured to detect and analyze genes or their products which are over-expressed or over-active in cells undergoing unwanted proliferation, or to detect abnormal cellular proliferation. 
     
     
         134 . The array of  claim 122 , comprising imaging means. 
     
     
         135 .- 151 . (canceled) 
     
     
         152 . A device, comprising a plurality of reservoirs and a plurality of needles arranged in an array for delivering one or more fluid agents to a plurality of positions along mutually parallel axes within a tissue of a subject. 
     
     
         153 . The device of  claim 152 , further comprising means for separately obtaining or analyzing biological samples at the sites of administration. 
     
     
         154 . The device of  claim 152 , wherein each one of said plurality of reservoirs is in fluid communication with a respective one of said plurality of needles, allowing separate release of said one or more fluid agents in separate reservoirs. 
     
     
         155 . The device of  claim 152 , wherein each one of said plurality of reservoirs is loaded with different fluid agents and/or different dosage of said agents, which can be released independently, optionally further comprising means for controlling release selected from the group consisting of a microprocessor, a controller and a patient scanning device. 
     
     
         156 . The device of  claim 152 , wherein said plurality of reservoirs comprise biodegradable polymeric carrier to control the release of said one or more fluid agents. 
     
     
         157 . The device of  claim 152 , providing an amount of said one or more fluid agents to be locally delivered to said tissue. 
     
     
         158 .- 159 . (canceled) 
     
     
         160 . The device of  claim 152 , wherein the means for obtaining or analyzing biological samples are biopsy mechanisms. 
     
     
         161 . (canceled) 
     
     
         162 . The device of  claim 152 , comprising an assay component configured to detect and analyze an altered physiologic state include cell viability, cell division, apoptosis, necrosis, cell surface marker expression and cellular activation state. 
     
     
         163 . The device of  claim 152 , further comprising imaging means. 
     
     
         164 . (canceled) 
     
     
         165 . A device, comprising an array of needles for separately obtaining or analyzing biological samples from different sites of a tissue within an individual. 
     
     
         166 .- 179 . (canceled)