NEEDLE ARRAY ASSEMBLY AND METHOD FOR DELIVERING THERAPEUTIC AGENTS
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 fluid 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 .- 17 . (canceled)
18 . A device for delivery of one or more agents into a tumor, comprising: two or more needles arranged in an array configured to deliver said one or more agents into said tumor.
19 . The device of claim 18 , wherein said one or more agents comprise two or more agents.
20 . The device of claim 18 , wherein said two or more needles arranged in an array comprise six or more needles arranged in an array and wherein said one or more agents comprise six or more agents.
21 . The device of claim 18 , wherein said two or more needles arranged in an array comprise ten or more needles arranged in an array and wherein said one or more agents comprise ten or more agents.
22 . The device of claim 18 , wherein a first agent is delivered through a first needle of said two or more needles arranged in an array and a second agent is delivered through a second needle of said two or more needles arranged in an array.
23 . The device of claim 18 , wherein each needle of said two or more needles arranged in an array is configured to deliver a separate agent of said one or more agents into said tumor.
24 . The device of claim 18 , wherein at least one of said two or more needles is configured for passive delivery of said one or more agents.
25 . The device of claim 18 , wherein said two or more needles are configured for fluid pressure delivery of said one or more agents.
26 . The device of claim 18 , wherein at least one of said two or more needles comprises micropits over their surfaces.
27 . The device of claim 18 , wherein at least one of said two or more needles is charged with said one or more agents by immersion in said one or more agents.
28 . The device of claim 18 , wherein at least one of said two or more needles is made from porous material.
29 . The device of claim 18 , wherein at least one of said two or more needles comprises a plurality of ports.
30 . The device of claim 29 , wherein said plurality of ports are sized and positioned to deliver a substantially equal amount of said one or more agents.
31 . The device of claim 29 , wherein said plurality of ports is evenly distributed along a portion of a length of said two or more needles.
32 . The device of claim 29 , wherein a size of each of said plurality of ports is inversely related to a distance of said port from a tip-end of said two or more needles.
33 . The device of claim 29 , wherein a distribution density of said plurality of ports is inversely related to a distance of said port from a tip-end of said two or more needles.
34 . The device of claim 29 , wherein said plurality of ports is distributed in a spiral pattern along a length of said two or more needles.
35 . The device of claim 29 , wherein said plurality of ports is arranged in pairs of ports on opposite sides of said needle with said pair rotated 90 degrees with respect to an adjacent pair of ports along a length of said two or more needles.
36 . The device of claim 18 , wherein an amount of said one or more agents delivered to said tumor is less than 1 microliter.
37 . The device of claim 18 , wherein an amount of said one or more agents delivered to said tumor is less than 5 microliters.
38 . The device of claim 18 , wherein at least one of said two or more needles is close-ended.
39 . The device of claim 18 , wherein said device delivers a first agent to a plurality of positions within said tumor.
40 . The device of claim 18 , wherein said device delivers a plurality of different agents to a plurality of different positions within said tumor.
41 . The device of claim 18 , wherein at least one of said one or more agents is delivered to said tumor in an amount that is less than a systemically delivered minimal dose required to produce a detectable effect in an adult.
42 . The device of claim 18 wherein at least one of said one or more agents is delivered to said tumor in an amount that is undetectable outside said tumor.
43 . The device of claim 18 , wherein at least one of said one or more agents is delivered to said tumor in a therapeutically effective amount.
44 . The device of claim 18 , wherein at least one of said one or more agents is delivered to said tumor in an amount substantially equivalent to an amount that could be detected inside said tumor if said agent were delivered systemically.
45 . The device of claim 18 , further comprising linkage to a data processing system.
46 . The device of claim 45 , wherein said data processing system is in communicable connection with said needle array.
47 . The device of claim 18 , wherein said tumor comprises lymph node tissue.
48 . The device of claim 18 , wherein said tumor comprises a tissue selected from a group consisting of: brain, liver, lung, kidney, prostate, ovary, spleen, lymph node, thyroid, pancreas, heart, skeletal muscle, intestine, larynx, esophagus and stomach, or any combination thereof.
49 . The device of claim 18 , wherein said tumor is a cancer selected from a group consisting of: adenoma, adenocarcinoma, squamous cell carcinoma, basal cell carcinoma, small cell carcinoma, large cell undifferentiated carcinoma, chondrosarcoma and fibrosarcoma, or any combination thereof.
50 . The device of claim 18 , wherein said one or more agents comprises an anti-cancer agent.
51 . The device of claim 18 , wherein said one or more agents comprises a chemotherapy agent.
52 . The device of claim 18 , wherein said one or more agents comprises a position marker.
53 . The device of claim 52 , wherein said position marker correlates to an injection site of said one or more agents.
54 . The device of claim 18 , wherein said device delivers said one or more agents transcutaneously.
55 . The device of claim 18 , wherein said device delivers said one or more agents subcutaneously.
56 . The device of claim 18 , wherein said device delivers said one or more agents using a delivery technique selected from a group consisting of: intramuscularly, intramedullary, and intrasternally, or any combination thereof.
57 . The device of claim 18 , wherein said device delivers said one or more agents directly into said solid tissue.
58 . The device of claim 18 , wherein said device delivers said one or more agents to skin.
59 . The device of claim 18 , wherein said device is configured to deliver said one or more agents in vivo.
60 . The device of claim 18 , wherein said device is configured to deliver said one or more agents in situ.
61 . The device of claim 18 , wherein said device is configured to deliver said one or more agents to said tumor wherein said tumor is ex vivo.
62 . The device of claim 18 , further comprising one or more reservoirs and one or more actuators.
63 . The device of claim 62 , wherein said one or more reservoirs are in fluid communication with said two or more needles and wherein said one or more actuators are operatively coupled to said one or more reservoirs and configured to control a fluid pressure within said one or more reservoirs.
64 . The device of claim 18 , further comprising one or more plungers having a first end positioned in a reservoir and a plunger driver coupled to a second end of said one or more plungers.
65 . The device of claim 64 , wherein said plunger driver is configured to depress said one or more plungers at a selectably variable rate.
66 . The device of claim 64 , wherein said plunger driver is configured to depress said one or more plungers simultaneously.
67 . The device of claim 64 , wherein said plunger driver comprises a driver shaft coupled to said one or more plungers and having a threaded region, wherein said plunger driver is configured such that rotation of said driver shaft in a first direction depresses said one or more plungers a distance corresponding to a thread pitch of said threaded region and a number of revolutions of said driver shaft.
68 . The device of claim 67 , further comprising a motor having a rotor coupled to said driver shaft, wherein said rotor and said driver shaft are rotationally fixed with respect to each other.
69 . The device of claim 68 , wherein said motor controls rotation of said rotor at a selectably variable rate
70 . A device for delivery of six or more agents into a tumor, comprising: six or more needles arranged in an array configured to deliver said six or more agents into said tumor wherein a first of said six or more agents is introduced in an amount that is less than a minimal dose required to produce a detectable effect in an adult.