Autonomous, ambulatory analyte monitor or drug delivery device

• US 8,303,518 B2
• Filed: 12/20/2005
• Issued: 11/06/2012
• Est. Priority Date: 02/08/2002
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Aceti, John Gregory, Moroney, Richard Morgan, Gregory, Christopher Carter, Zanzucchi, Peter John, Mcbride, Sterling Eduard
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/311,667
• Publication Number:
  US 20060094985A1
• Time in Patent Office: 2,513 Days
• Field of Search: 600/583, 604/180, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150526 Curved or bent needles
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/155 : Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 : having a channel at the side surface
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence

Abstract

The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The electronics portion includes a processor and associated circuitry (e.g., memory, supporting electronics and the like), a motor or the like, a sensor, a power supply (e.g., battery) and optionally an interface. In general, the processor controls the operation of the device and is data communication with the actuator, motor, sensor and interface. The invention provides for autonomous operation, that is, without intervention of the user. The invention can optionally provide for calibration without intervention of the user. The invention can also provide for semi-continuous monitoring for day and night time. The invention can provide for up to four, or more, weeks of operation. The invention can provide for a device that is relative small in size, and therefore unobtrusive. The invention can also provide for device with remote control and interactive electronics. The invention may be also used for the delivery of various pharmaceutical agents including high potency drugs to minimize patient intervention and minimize discomfort.

Claims

1. An analyte monitoring device operable to draw a fluid sample from a subject, the device comprising:

a plurality of microneedles disposed on a carrier,

a plurality of microchannels defined as openings in said carrier, wherein each of the plurality of microneedles is at least intermittently in fluid communication with a corresponding microchannel, wherein each of the plurality of microneedles is connected to and moveable with a corresponding fluidic capture site and is constructed and arranged to collect the fluid sample from the subject, wherein the corresponding fluidic capture site is configured to fluidly couple to and deliver the fluid sample to at least one of the plurality of microchannels, and wherein each microchannel is associated with a reagent,

at least one actuator operable to extend each microneedle and corresponding fluidic capture site to collect the fluid sample from the subject and to deliver the fluid sample to the at least one of the plurality of microchannels, and

a controller operable to initiate analyte testing of the fluid sample.

2. The device of claim 1 wherein each of the first plurality of microneedles has an internal diameter in the range of about 25 to 200 micrometers.

3. The device of claim 1 wherein each of the first plurality of microneedles is fabricated from at least one of metal, plastic, glass and crystal.

4. The device of claim 1 wherein each of the first plurality of microneedles has a distal end that is operable to penetrate into a skin surface to a maximum of about 2.5 mm.

5. The device of claim 1 wherein the fluid sample is substantially blood.

6. The device of claim 1 wherein each of the first plurality of microneedles is at least intermittently in fluid communication with a microchannel via a conduit.

7. The device of claim 1 wherein each microchannel is operable to store the fluid sample and accumulation of the fluid sample in the microchannel is entirely dependent on capillary forces.

8. The device of claim 1 wherein each of the microchannels has at least one internal surface that is at least partially coated with at least one insoluble material to enhance the capillary forces and minimize coagulation.

9. The device of claim 1 wherein the plurality of microchannels are fabricated in an array.

10. The device of claim 1 wherein the microchannels are fabricated in an array having approximately 50-150 microchannels formed in a maximum diameter of approximately 5 cm.

11. The device of claim 1 wherein each of the first plurality of microneedles is dimensioned for volumes of fluid in the range of about 50-500 nanoliters.

12. The device of claim 1 comprising a detector operable to determine when the fluid sample completely fills at least one microchannel such that the accumulation of the fluid sample with the associated microneedle may be terminated.

13. The device of claim 1 wherein at least one microchannel is in fluid communication with at least one reagent operable to assay for analytes selected from the group of (a) glucose, (b) cholesterol, (c) ethanol, (d) digoxin, (e) HDL cholesterol, (f) lithium, (g) sodium, (h) phenytoin, (i) therophylline, (j) cyclosporine, (k) cancer chemotheraphy drugs, (l) DNA, (m) RNA, (n) extended phenytonin sodium, (o) warfarin sodium, and (p) proteins derived from blood.

14. The device of claim 1 wherein at least two microchannels are associated with a single microneedle so that multiple assays can be performed using a single microneedle.

15. The device of claim 1 wherein at least one monitoring microchannel is sealed with a polymer.

16. The device of claim 1 wherein the plurality of microneedles, plurality of microchannels and the reagent are contained in a disposable cartridge.

17. The device of claim 16, further comprising a reusable module receiving the disposable cartridge therein.

18. The device of claim 17, wherein the disposable cartridge further comprises an electromechanical interface for the reusable module.

19. The device of claim 1, wherein each of the plurality of microneedles comprises an internal bore in direct fluid communication with a respective microchannel.

20. The device of claim 19, wherein each of the plurality of microchannels is disposed directly above a respective microneedle.

21. The device of claim 20, further comprising a cover at least partially enclosing at least one of the plurality of microchannels.

22. The device of claim 1, further comprising an optical sensor constructed and arranged to make colorimetric measurements for determining a concentration of the analyte contained in the fluid sample.

23. The device of claim 22, wherein each microchannel and the associated reagent define a reaction site, and the device further comprising a blood detection sensor constructed and arranged to detect the presence of blood at the reaction site.

24. The device of claim 23, wherein the blood detection sensor comprises the optical sensor, and the optical sensor is constructed and arranged to detect the presence of blood at the reaction site prior to the determination of the concentration of the analyte contained in the fluid sample.