METHOD AND IMPLANTABLE DEVICE WITH RESERVOIR ARRAY FOR PRE-CLINICAL IN VIVO TESTING

• US 20080076975A1
• Filed: 07/31/2007
• Published: 03/27/2008
• Est. Priority Date: 01/25/2005
• Status: Abandoned Application

• Current Assignee: MicroCHIPS Inc.
• Original Assignee: MicroCHIPS Inc.
• Inventors: Ausiello, Dennis, Santini, John
• Application Number:
  US11/831,772
• Publication Number:
  US 20080076975A1
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02

Abstract

Methods of pre-clinical animal testing to monitor physiological parameters of test animals following exposure of molecules sealed in reservoirs on implanted devices. The test molecules are exposed to physiological fluid of the animal. The molecules can be configured as a sensor chemistry that reacts with the physiological fluid. The molecules can be a drug or drug candidate that is released into the animal. The test animals are non-human mammals.

Claims

1. A method of conducting a pre-clinical animal study comprising the steps of:

implanting into a non-human test animal a device which comprises;

a body portion,

a plurality of discrete reservoirs located in the body portion, each reservoir

having at least one opening,

molecules disposed within the reservoirs,

a plurality of discrete reservoir caps, each closing off the at least one

opening of each of the reservoirs, and

activation means for selectively disintegrating or permeabilizing each said

reservoir cap to expose the molecules in the reservoir;

exposing, via the activation means, at least a first amount of the molecules to a physiological fluid of the test animal; and

monitoring one or more physiological parameters of the test animal following exposing of the molecules.

2. The method of claim 1, wherein at least one of the plurality of reservoirs is configured as a sensor, the molecules disposed within the reservoir defining a sensor chemistry,

said step of exposing exposes said sensor chemistry, and

said step of monitoring monitors a result of an interaction of said sensor chemistry with said physiological fluid.

3. The method of claim 1, wherein said step of exposing the at least first amount of the molecules comprises releasing said molecules from at least one of the reservoirs into the test animal.

4. The method of claim 1, wherein exposure of the molecules is initiated by a preprogrammed microprocessors or state machine, by wireless telemetry, and/or by feedback from one or more sensors.

5. The method of claim 2, wherein the one or more sensors are implanted into the test animal.

6. The method of claim 5, wherein a plurality of the sensors are sealed inside a second plurality of reservoirs until needed for sensing.

7. The method of claim 2, wherein the one or more sensors are external to the body of the test animal.

8. The method of claim 1, further comprising exposing a second amount of the molecules into the test animal, and further monitoring one or more physiological parameters of the test animal following the exposure of the second amount of the molecules.

9. The method of claim 3, further comprising releasing a second amount of the molecules into the test animal, and further monitoring one or more physiological parameters of the test animal following the release of the second amount of the molecules.

10. The method of claim 9, comprising changing the dose and/or dosing schedule of the first and second amounts of the molecules.

11. The method of claim 1, wherein the molecules comprises a drug or drug candidate.

12. The method of claim 3, wherein the molecules comprises a drug or drug candidate.

13. The method of claim 1, wherein the molecules are chosen from the group of DNA, RNA, other nucleic acids, gene sequences or fragments, aptamers, other genetic material, and molecules that affect or modulate the expression of a gene.

15. The method of claim 1, wherein the test animal is a mammal.

16. The method of claim 1, wherein the test animal is selected from the group consisting of rats, dogs, cats, pigs, sheep, and non-human primates.

14. (canceled)