Needle array assembly and method for delivering therapeutic agents

Inventors

Bahrami, S. Bahram • Veiseh, Mandana • Olson, James

Assignees

Presage Biosciences Inc • Fred Hutchinson Cancer Center

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 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.

Core Innovation

The described invention provides an in vivo method of rating one or more candidate agents for development into a therapeutic agent for treating solid tissue. One or more candidate agents are introduced into solid tissue by distributing each candidate agent to a plurality of positions along an axis, including introduction into a tumor, and the candidate agents are evaluated on the solid tissue and the effects of the candidate agents are compared.

The rating rule assigns a higher rating for development to an agent that results in a greater beneficial effect when introduced to a tumor and a lower rating to an agent that results in a lesser beneficial effect when introduced to the tumor. Evaluation includes determining effectiveness of the candidate agents in solid tissue, and the evaluated effects may include efficacy/activity/toxicity and indicators of altered physiologic state.

The invention further incorporates embodiments for introducing the candidate agents, including distribution along an axis using needle-array fluid delivery. In some embodiments, the needle array includes reservoirs and actuators controlling rate, volume, and direction, and delivery can include multiple side ports distributed along the length of each needle. The described embodiments support substantially equal fluid delivery along delivery axes at low volumes per needle, and may include passive delivery needle alternatives.

Claims Coverage

The independent claim covers a method of rating one or more candidate agents for development into a therapeutic agent for treating solid tissue by distributing candidates to multiple positions along an axis, evaluating effectiveness, and comparing effects to assign higher or lower ratings based on beneficial effect outcomes in a tumor. The inventive features are further refined in dependent claims.

Across the claims, candidate agents are introduced into solid tissue in spatially defined positions along an axis, effectiveness is evaluated, and agent effects are compared to assign higher or lower ratings based on beneficial effect in a tumor. Dependent refinements include passive needle delivery, spatial delivery along parallel axes, and evaluating permeation through solid tissue.

Stated Advantages

Documented Applications