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Implantable Devices And Methods For The Evaluation of Active Agents

a technology of active agents and implantable devices, which is applied in the field of implantable devices and methods for the evaluation of active agents, can solve problems such as failure to account for patient-specific factors, and achieve the effect of accurately predicting the systemic drug respons

Inactive Publication Date: 2013-07-18
KIBUR MEDICAL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent is about a device that can be implanted directly into tumors to test them with a variety of drugs to see which ones are effective without causing harmful side effects. This allows for faster and more accurate testing while under actual physiological conditions. The device can also be used with genomic data to better predict how well a drug will work in a patient.

Problems solved by technology

In spite of this understanding, most clinical treatments still follow established standard-of-care guidelines and paradigms which fail to account for patient-specific factors.

Method used

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  • Implantable Devices And Methods For The Evaluation of Active Agents
  • Implantable Devices And Methods For The Evaluation of Active Agents
  • Implantable Devices And Methods For The Evaluation of Active Agents

Examples

Experimental program
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example 1

Prototype Testing in Mouse Model

[0104]Materials and Methods

[0105]As shown in FIG. 5, a mouse model for a human cancer cell line is prepared by injection of human cancer cells such as MDA MB-231 into the mammary fat pad of an immunodeficient mouse. Tumors are allowed to implant and proliferate to approximately 150-170 mm3.

[0106]Individual drugs are administered systemically by injection to the mice to establish local pharmacokinetics for the drugs. For breast cancer cells, representative drugs to be tested include docetaxel, doxorubicin, irinotecan, transtuzumab, and bevacizumab.

[0107]Devices were tested in approximately 50 animals for biocompatibility and integration with tissue. Data was obtained by computed tomography, magnetic resonance and histopathology.

[0108]A device with 14 reservoirs was loaded with approximately 1.5 microgram doxorubicin (crystalline powder) per reservoir. The device can be loaded with the same drugs based on the results of the systemic testing. Each drug i...

example 2

Methods for Controlled Local Release of Drugs into Tissue

[0114]Materials and Methods

[0115]Several methods for controlling the release / diffusion of compounds into tissue, including precise spatial placement of reservoirs along device mantle; geometry and size of reservoirs; and formulation of released compounds, were developed. In this manner, the device reservoirs from which the compounds diffuse are engineered to expose only regions of tissue that are directly adjacent to the reservoir opening, to the released compound. This creates distinct local regions in which the effect of compounds can be assessed without interference of other compounds released from different reservoirs.

[0116]Results

[0117]Cross-section of device shows release of two compounds. Drug A was released upward and diffused into a larger region, while Drug B was released downward into a relatively smaller region.

[0118]The precise control over the transport time as a function of distance from reservoirs is shown in F...

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Abstract

Devices for the local delivery of microdose amounts of one or more active agents, alone or in combination, in one or more dosages, to selected tissue of a patient are described. The devices generally include multiple microwells arranged on or within a support structure. The microwells contain one or more active agents, alone or in combination, in one or more dosages and / or release pharmacokinetics. In an exemplary embodiment, the device has a cylindrical shape, having symmetrical wells on the outside of the device, each well containing one or more drugs, at one or more concentrations, sized to permit placement using a catheter, cannula, or stylet. Optionally, the device has a guidewire, and fiber optics, sensors and / or interactive features such as remote accessibility (such as WiFi) to provide for in situ retrieval of information and modification of device release properties. In the most preferred embodiment, the fiber optics and / or sensors are individually accessible to discrete wells.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of and priority to U.S. Provisional Application No. 61 / 582,009 entitled “Implantable Devices and Methods for the Evaluation of Active Agents” by Robert I. Tepper, Jason Fuller, Oliver Jonas, and John Santini, filed on Dec. 30, 2011, and where permissible is incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The invention is generally related to devices, methods, systems, and kits for the evaluation of therapeutic agents in situ within tissues to be treated in patients.BACKGROUND OF THE INVENTION[0003]In recent years, research has demonstrated that the progression of many diseases is governed by molecular and genetic factors which are patient specific. For example, it is now understood that cancer is driven by diverse genetic and epigenetic factors which are often patient specific. As a result, disease progression and anti-cancer drug response is unique to every patient. In spite of thi...

Claims

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Application Information

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IPC IPC(8): G01N33/50A61M5/00
CPCA61K9/0097A61M5/00A61B10/0266A61B5/6861A61B5/0084G01N33/5008F04C2270/041A61B2010/045B33Y80/00A61B5/0017A61B5/4848A61B5/6851A61B2562/12
Inventor TEPPER, ROBERT I.FULLER, JASONJONAS, OLIVERSANTINI, JOHN
Owner KIBUR MEDICAL INC
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