Device and method for drug evaluation and local treatment

• US 10,080,876 B2
• Filed: 08/20/2009
• Issued: 09/25/2018
• Est. Priority Date: 08/21/2008
• Status: Active Grant

• Current Assignee: Kibur Medical Inc.
• Original Assignee: Kibur Medical Inc.
• Inventors: Tepper, Robert I., Hirsch, Russell, Fuller, Jason E., Duda, Jessica L., Muir, Craig, Ross, Jeffrey S., Flaherty, J. Christopher
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US13/060,040
• Publication Number:
  US 20110230736A1
• Time in Patent Office: 3,323 Days
• Field of Search: 600309, 600310, 600316, 600322, 600344, 600473, 600476, 604 9301, 604272, 604154, 604155, 604191, 6048901, 6048911, 6048921, 604131, 604151, 604153, 604156, 604 21
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Described here are devices, systems, and kits for delivering substances to tissues. The devices generally include one or more chambers (102) and a reservoir (108) within each chamber. The reservoir may locally deliver a microdose amount of a substance to a target tissue. In some variations, a microdose amount is used in early human studies, e.g., before a phase I clinical trial, to evaluate the effect of the substance on a target tissue, or to obtain pharmacokinetic or metabolic data. In other variations, a microdose amount is used to locally treat a medical condition. In yet other variations, a microdose amount is used to locally deliver a contrast agent for a structural or functional imaging procedure. Methods for delivering and retrieving the devices from the target tissue are also described.

Claims

1. A microarray device comprising:

an elongated support structure configured for administration within a needle, laparoscope, endoscope, arthroscope, or catheter,

arrays along the length of the elongated support structure of multiple separate chambers being formed within the support structure, each chamber having a closed proximal end on the interior of the support structure and an open distal end on the outside of the support structure,

each chamber comprising a solid matrix forming a reservoir containing microdoses of one or more therapeutic or diagnostic agents in the matrix, which are released into the open distal end only over a period between about one day and one week following insertion of the microarray device into tissue,

wherein the open distal end of the chamber is configured to place the tissue in close proximity to the solid matrix from which agent is released, and

wherein the device is configured to allow removal of the device at the same time as a sample of tissues, cells or fluid at the site of administration into which therapeutic or diagnostic agent is released from each chamber for separately sampling or analyzing of the tissue or cells adjacent to the distal end of the chambers.

2. The microarray device of claim 1 further comprising a deployment device configured for a laparoscopic, endoscopic, arthroscopic, or catheter-based procedure that separately extracts, samples or analyzes the tissue or cells at the sites of administration.

3. The microarray device of claim 1 wherein each of the reservoirs is loaded with different substances or different microdose amounts of the substances, which are released independently.

4. The microarray device of claim 1 wherein the reservoirs comprise biodegradable polymeric matrices which release agent as a function of diffusion or degradation.

5. The microarray device of claim 1 comprising a sensor selected from the group consisting of a strain gauge, an accelerometer, a temperature sensor, a pH sensor, a chemical sensor, a mechanical sensor, a radiation sensor and a physiologic sensor configured to assess one or more cell activities.

6. The microarray device of claim 1 wherein a biopsy device is used for extracting the microarray device or sampling or analyzing the tissue or cells adjacent to the distal end of the chambers.

7. The microarray device of claim 1 comprising an assay to detect analytes indicative of inflammation, to detect and analyze genes or their products which are over-expressed or over-active in cells undergoing unwanted proliferation, to detect infection or to detect abnormal cellular proliferation.

8. The microarray device of claim 1 comprising an imaging device.

9. The microarray device of claim 1 is in combination with a deployment or retrieval device or system.

10. The microarray device of claim 1 further comprising biopsy or assay devices, or a combination thereof, that separately sample or analyze the tissue or cells immediately adjacent to the reservoir.

11. The microarray device of claim 10 comprising a sensor selected from the group consisting of a strain gauge, an accelerometer, a temperature sensor, an optical sensor, a pH sensor, a chemical sensor, a mechanical sensor, a radiation sensor, a physiologic sensor configured to assess one or more cell activities and combinations of these sensors.

12. The microarray device of claim 10 comprising penetrating members.

13. The microarray device of claim 10 comprising a sensor or an assay to detect analytes indicative of inflammation, to detect and analyze genes or their products which are over-expressed or over-active in cells undergoing unwanted proliferation, to detect infection or to detect abnormal cellular proliferation, to detect an effect or response of the target tissue to the agent being released, or to visualize cellular or histological/histopathological changes in response to the agent being released.

14. The microarray device of claim 10 comprising an imaging device.

15. The microarray device of claim 10 in combination with a deployment or retrieval device.

16. A method for delivering therapeutic or diagnostic agent to cells or tissue in an individual, and extracting, sampling or analyzing the tissue or cells comprising:

providing the microarray device of claim 1 and then separately extracting, sampling or analyzing the tissue or cells at the sites of administration.

17. The method of claim 16 comprising administering different amounts of the same therapeutic or diagnostic agent from the different reservoirs.

18. The method of claim 16 comprising administering different therapeutic or diagnostic agents from the different reservoirs.

19. The method of claim 16 comprising administering therapeutic or diagnostic agent in response to analysis or sampling of the cells or tissue.

20. The method of claim 16 further comprising determining sensitivity of the tissue or cells to a therapeutic agent.

21. A method for extracting tissue or cells comprising

providing the microarray device and the biopsy device of claim 10 and extracting cells or tissue immediately adjacent to the reservoir.

22. The microarray device of claim 3 further comprising a device configured to control release selected from the group consisting of a preprogrammed microprocessor, remote control, and one or more sensors.

23. The microarray device of claim 1, further comprising an imaging component for visualizing the device within the tissue.