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Publication Number
US-10478157-B2
Publication Date
2019-11-19
Expiration Date
Abstract
Methods and devices for delivering an agent to a solid tissue in vivo for assessment of efficacy are described. One method involves withdrawing of a needle from and injecting of the agent into the solid tissue; another method involves delivering the agent using a plurality of microdialysis probes to a solid tissue.
Core Innovation
The invention relates to delivering one or more agents to a solid tumor of a subject using a needle array device. The device inserts five or more needles into the solid tumor and delivers the agents through the needles while simultaneously withdrawing the needles from the solid tumor.
The method is positioned for in vivo assessment of efficacy and biological effects in solid tissue, notably tumor tissue, by enabling controlled local agent delivery within the tumor. The delivery concept is used alongside evaluation of biological effects and biomarkers, including cell death, apoptosis, necrosis, proliferation, and signal transduction, with the ability to map agent distribution using positional marking and multiple sampling locations within the tumor.
The disclosure also describes devices and operational concepts that support insertion and targeting consistency, including stabilizing and guiding needle insertion with depth/control mechanisms and an array head. Positional mapping and distribution assessment can be performed using dyes, fluorescent dyes, markers, and GCMS tag molecules, and the resulting tissue outcomes can be examined with fluorescent imaging and histology approaches.
Claims Coverage
The partial document identifies one independent claim (clm-00001). The claim set covers a five-or-more-needle array delivery method to a solid tumor with simultaneous needle withdrawal during injection, and multiple dependent claim refinements that specify agent types, multi-agent delivery patterns, insertion-site marking, and evaluation/imaging timing.
Needle array device inserted into the solid tumor
Inserting one or more needles of a needle array device into said solid tumor, said needle array device comprising five or more needles.
Injecting agents through the needle array while simultaneously withdrawing the needles
Injecting said one or more agents into said solid tumor via said one or more needles of said needle array device while simultaneously withdrawing said one or more needles from said solid tumor.
Across the independent claim and identified dependent refinements, the core coverage is simultaneous injection and needle withdrawal using a needle array having five or more needles to deliver one or more agents to a solid tumor. Additional refinements described in the partial content include multi-agent specificity (different agents across needles and/or different concentrations), insertion-site position marking, and timing of imaging/evaluation relative to agent introduction.
Stated Advantages
Enables controlled local agent delivery within the tumor for in vivo assessment of efficacy and biological effects in solid tissue.
Supports mapping of agent distribution and examination of tissue outcomes with fluorescent imaging and histology approaches.
Documented Applications
No documented applications found
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