COMPACT MINIMALLY INVASIVE BIOMEDICAL MONITOR

• US 20070276211A1
• Filed: 05/29/2007
• Published: 11/29/2007
• Est. Priority Date: 05/26/2006
• Status: Abandoned Application

• Current Assignee: Infotonics Technology Center, Inc.
• Original Assignee: Infotonics Technology Center, Inc.
• Inventors: Mir, Jose, Lee, James
• Application Number:
  US11/754,987
• Publication Number:
  US 20070276211A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

A biomedical monitor is disclosed. The biomedical monitor has an array of moveable microneedles coated with a first chemical sensing media. The biomedical monitor also has an actuator configured to move at least one microneedle in the array of microneedles from a retracted position to an engaged position whereby the at least one microneedle enters a subject'"'"'s skin. The biomedical monitor further has an optical system configured to illuminate the at least one microneedle during or after entering the subject'"'"'s skin and monitor the first chemical sensing media from the at least one microneedle, whereby at least one biomedical characteristic is determined based on at least one spectral property of the monitored first chemical sensing media. A method of monitoring at least one biomedical characteristic is also disclosed.

Claims

1. A biomedical monitor, comprising:

an array of moveable microneedles coated with a first chemical sensing media;

an actuator configured to move at least one microneedle in the array of microneedles from a retracted position to an engaged position whereby the at least one microneedle enters a subject'"'"'s skin;

an optical system configured to illuminate the at least one microneedle during or after entering the subject'"'"'s skin and monitor the first chemical sensing media from the at least one microneedle, whereby at least one biomedical characteristic is determined based on at least one spectral property of the monitored first chemical sensing media.

2. The biomedical monitor of claim 1, wherein the array of microneedles comprise:

a substrate that defines a plurality of wells which house the microneedles in the array of moveable microneedles; and

one or more restoring spring elements coupled to each microneedle in the array of moveable microneedles.

3. The biomedical monitor of claim 2, wherein the one or more restoring spring elements are selected from the group consisting of a spiral spring, a cantilever spring, a flexible elastic membrane, and rubber.

4. The biomedical monitor of claim 2, wherein the substrate further comprises a material selected from the group consisting of silicon, silicon dioxide, silicon nitride, plastic, metal, glass, and dielectric material.

5. The biomedical monitor of claim 2, wherein the substrate further defines a cylindrical alignment slot for assisting in alignment of the array of microneedles with the actuator.

6. The biomedical monitor of claim 2, wherein the substrate further defines one or more positional encoder slots for assisting in alignment of the array of microneedles with the actuator.

7. The biomedical monitor of claim 6, wherein a ratio of positional encoder slots to microneedles is 1:

1.

8. The biomedical monitor of claim 1, wherein the chemical sensing media comprises a media which changes color when in contact with a specific chemical specie.

9. The biomedical monitor of claim 1, wherein the chemical sensing media comprises a media which fluoresces when in contact with a specific chemical specie.

10. The biomedical monitor of claim 1, wherein the chemical sensing media comprises a material selected from the group consisting of glucose oxidase, glucose dehydrogenase, hexokinase-glucokinase, rhenium bipyridine, boronic acid having flourophores, NBD-fluorophores.

11. The biomedical monitor of claim 1, wherein the chemical sensing media comprises a polymeric matrix.

12. The biomedical monitor of claim 1, wherein the at least one biomedical characteristic is selected from the group consisting of cholesterol, HDL cholesterol, alcohol, estrogen-progesterone, cortisol, a physiological chemical, an ingested chemical, and an exposed chemical.

13. The biomedical monitor of claim 1, wherein the microneedles in the array of moveable microneedles are transparent.

14. The biomedical monitor of claim 1, wherein the microneedles in the array of moveable microneedles are translucent.

15. The biomedical monitor of claim 1, further comprising a second chemical sensing media, wherein at least one of the microneedles in the array of moveable microneedles is coated with the second chemical sensing media.

16. The biomedical monitor of claim 15, wherein the at least one microneedle coated with the second chemical sensing media is not coated with the first chemical sensing media.

17. The biomedical monitor of claim 15, wherein the at least one microneedle coated with the second chemical sensing media is also coated with the first chemical sensing media.

18. The biomedical monitor of claim 1, wherein the actuator comprises a plurality of individually addressable actuators which are configured to individually actuate each microneedle in the array of moveable microneedles.

19. The biomedical monitor of claim 18, wherein the individually addressable actuators comprise microsolenoids.

20. The biomedical monitor of claim 1, wherein the actuator comprises:

an actuation substrate which is configured to be rotated relative to the array of moveable microneedles;

a biasing device for biasing the actuation substrate towards the array of moveable microneedles; and

at least one depressor coupled to the actuation substrate for engaging at least one of the microneedles in the array of moveable microneedles using a force from the biasing device when the at least one depressor is aligned with the at least one microneedle.

21. The biomedical monitor of claim 20, wherein the biasing device comprises a solenoid.

22. The biomedical monitor of claim 20, wherein the biasing device is manually activated.

23. The biomedical monitor of claim 20, wherein the biasing device is a spring-loaded device.

24. The biomedical monitor of claim 20, wherein the actuation substrate comprises a toothed-surface for receiving rotational motion from a driven gear.

25. The biomedical monitor of claim 1, wherein the optical system comprises:

a light source configured to illuminate the at least one microneedle during or after entering the subject'"'"'s skin; and

an image sensor configured to monitor the at least one spectral property of the first chemical sensing media.

26. The biomedical monitor of claim 25, wherein the image sensor is selected from the group consisting of:

a CCD sensor, a multi-channel CCD sensor, a CMOS image sensor, a multi-channel CMOS image sensor, a spectrometer, a Bayer sensor, and a Foveon X3 sensor.

27. The biomedical monitor of claim 25, wherein the light source is selected from the group consisting of an incandescent light source, a light emitting diode, and a laser diode.

28. The biomedical monitor of claim 25, wherein the image sensor is oriented substantially over the at least one microneedle in the engaged position.

29. The biomedical monitor of claim 25, further comprising one or more optical elements to apply light from the light source to the at least one microneedle.

30. The biomedical monitor of claim 25, wherein the image sensor is configured to receive reflected light off of the first chemical sensing media from the light source.

31. The biomedical monitor of claim 25, wherein the image sensor is configured to receive diffuse light off of the first chemical sensing media from the light source.

32. The biomedical monitor of claim 1, wherein at least one microneedle in the microneedle array comprises a hollow needle.

33. The biomedical monitor of claim 1, wherein at least one microneedle in the microneedle array comprises a grooved needle.

34. The biomedical monitor of claim 1, wherein at least one microneedle in the microneedle array comprises a corrugated needle.

35. The biomedical monitor of claim 1, wherein the microneedle array comprises at least one needle of a first penetration depth and at least one needle of a second penetration depth which is different from the first penetration depth.

36. The biomedical monitor of claim 1, wherein the microneedle array comprises at least one needle with a cross-section that is selected from the group consisting of:

square, rectangular, triangular, and circular.

37. The biomedical monitor of claim 1, wherein the microneedle array comprises at least one needle with a varying cross-section.

38. The biomedical monitor of claim 1, further comprising a film configured to separate the microneedles of the microneedle array from the subject'"'"'s skin until each microneedle has been moved to the engaged position.

39. The replaceable array of moveable microneedles according to claim 38, further comprising a film covering tips of the microneedles and the at least one chemical sensing media.

40. The replaceable array of moveable microneedles according to claim 38, wherein the substrate further defines a cylindrical alignment slot.

41. The replaceable array of moveable microneedles according to claim 38, wherein the substrate further defines one or more positional encoder slots.

38-1. A replaceable array of moveable microneedles, comprising:

a plurality of microneedles coated with at least one chemical sensing media;

a substrate defining wells to house the microneedles; and

at least one restoring spring element coupled between each microneedle and the substrate such that each microneedle is held at least partially in an associated well.

42. A method of monitoring at least one biomedical characteristic, comprising:

engaging a first microneedle coated with a first chemical sensing media into a subject'"'"'s skin;

illuminating the first chemical sensing media;

monitoring one or more spectral characteristics of light reflected from the first chemical sensing media; and

determining at least one biomedical characteristic based on the one or more spectral characteristics of light reflected from the first chemical sensing media.

47. The method of claim 42, wherein the at least one biomedical characteristic is selected from the group consisting of cholesterol, HDL cholesterol, alcohol, estrogen-progesterone, cortisol, a physiological chemical, an ingested chemical, and an exposed chemical.

43. The method of claim 43, further comprising:

waiting a desired period of time;

engaging a second microneedle coated with a second chemical sensing media into the subject'"'"'s skin;

illuminating the second chemical sensing media;

monitoring one or more spectral characteristics of light reflected from the second chemical sensing media; and

determining at least one second biomedical characteristic based on the one or more spectral characteristics of light reflected from the second chemical sensing media.

44. The method of claim 43, wherein the first chemical sensing media and the second chemical sensing media comprise a same chemical sensing media.

45. The method of claim 43, wherein the at least one biomedical characteristic and the at least one second biomedical characteristic comprise a same biomedical characteristic.

46. The method of claim 43, further comprising, prior to engaging a second microneedle, withdrawing the first microneedle from the subject'"'"'s skin.