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Implantable devices and methods for evaluation of active agents

a technology of active agents and implantable devices, applied in the direction of guide wires, catheters, applications, etc., can solve the problems of not being able to account for patient-specific factors, and achieve the effect of accurately predicting the systemic drug respons

Inactive Publication Date: 2015-01-01
KIBUR MEDICAL INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes implantable devices that can be used to deliver microdoses of active agents to tissue, such as tumors or brain tissue. The devices contain multiple microwells that are designed to release the agents in a controlled and precise manner. The devices can be easily placed and retrieved using a catheter and can include features to maintain spatial stability of the tissue. In certain embodiments, the devices can be used to test the response of tumors to a variety of drugs, allowing for the identification of effective treatments and the accurate prediction of systemic drug response.

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 evaluation of active agents
  • Implantable devices and methods for evaluation of active agents
  • Implantable devices and methods for evaluation of active agents

Examples

Experimental program
Comparison scheme
Effect test

example 1

Prototype Testing in Mouse Model

[0138]Materials and Methods

[0139]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.

[0140]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.

[0141]Devices were tested in approximately 50 animals for biocompatibility and integration with tissue. Data was obtained by computed tomography, magnetic resonance and histopathology.

[0142]A device with 14 microwells was loaded with approximately 1.5 microgram doxorubicin (crystalline powder) per microwell. 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

[0148]Materials and Methods

[0149]Several methods for controlling the release / diffusion of compounds into tissue, including precise spatial placement of microwells along device mantle; geometry and size of microwells; and formulation of released compounds, were developed. In this manner, the device microwells from which the compounds diffuse are engineered to expose only regions of tissue that are directly adjacent to the microwell opening, to the released compound. This creates distinct local regions in the tissue in which the effect of compounds can be assessed without interference of other compounds released from different microwells. Creation of discrete areas of drug is extremely important if one is to assess the efficacy of the different agents, or combinations thereof, and / or dosages and / or times of release (sustained, pulsed, delayed, bolus followed by sustained, etc.).

[0150]Results

[0151]Cross-sectional images of tissue...

example 3

Defined and Segregated Release of Multiple Compounds from Adjacent Microwells

[0153]Materials and Methods

[0154]As in Example 2, different compounds were loaded into individual microwells in different formulations in order to control the rate of release of compounds into the tissue. Here, doxorubicin, lapatinib, and paclitaxel with distinct molecular weights (544 g / mol, 581 g / mol, and 854 g / mol, respectively) and physical properties were loaded into the device. The device was implanted into tissue. The device and surrounding tissue was removed twenty hours post-in vivo implantation. Diffusion of the compounds from the device was evaluated twenty hours post-in vivo implantation.

[0155]Results

[0156]Fluorescent imaging of cross-sections of the excised surrounding tissue showed diffusion of the compounds doxorubicin, lapatinib, and paclitaxel following in vivo implantation for twenty hours. Cross-sectional fluorescent imaging showed each compound being confined to the tissue in segregated ...

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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 and 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 to provide for in situ retrieval of information and modification of device release properties. In a preferred embodiment, the fiber optics and / or sensors are individually accessible to discrete wells.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application is a continuation-in-part of U.S. application Ser. No. 13 / 729,738 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. 28, 2012, which 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 specif...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B10/02A61B5/145A61M25/09A61B17/34A61B5/00A61M31/00
CPCA61B5/4848A61M25/09A61B10/0266A61M2207/10A61M31/002A61B5/145A61M2025/091A61B17/3468A61B5/0084A61B5/6861A61B10/0275A61K9/0024A61K9/0097A61M5/00A61M37/0069G01N1/31A61B10/0233A61M2202/06A61M2205/04A61M2207/00
Inventor TEPPER, ROBERT I.FULLER, JASONJONAS, OLIVERSANTINI, JOHN
Owner KIBUR MEDICAL INC
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