REPLACEABLE MICRONEEDLE CARTRIDGE FOR BIOMEDICAL MONITORING

• US 20110224515A1
• Filed: 09/08/2010
• Published: 09/15/2011
• Est. Priority Date: 09/08/2009
• Status: Abandoned Application

• Current Assignee: Sensivida Medical Technologies, Inc.
• Original Assignee: Sensivida Medical Technologies, Inc.
• Inventors: Sarbadhikari, Kamal K., Demejo, Larry, Spoonhower, John, Agostinelli, John A., Mir, Jose
• Application Number:
  US12/877,755
• Publication Number:
  US 20110224515A1
• Time in Patent Office: Days
• US Class Current: 600/317
• CPC Class Codes: A61B 2562/046 in a matrix array
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: A61M 2037/0061 : Methods for using microneedles

Abstract

A replaceable microneedle array for a biomedical monitor is disclosed. The microneedle array includes a plurality of moveable microneedles coated with at least one chemical sensing material coupled with a porous material. The microneedle array also includes a substrate defining wells to house the microneedles. The microneedle array further includes at least one restoring spring element coupled between each microneedle and the substrate such that each of the plurality of microneedles is held at least partially in an associated well.

Claims

1. A replaceable microneedle array, comprising:

a plurality of moveable microneedles coated with at least one chemical sensing material coupled with a porous material;

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 of the plurality of microneedles is held at least partially in an associated well.

2. The replaceable microneedle array of claim 1, further comprising a protective film on a microneedle facing side of the array and covering the wells.

3. The replaceable microneedle array of claim 2, further comprising:

a calibration position comprising a moveable calibration protrusion coated with the at least one chemical sensing material; and

a patterned deposit of a non-volatile reference analyte on the protective film at a location corresponding to the calibration position.

4. The replaceable microneedle array of claim 3, wherein the calibration protrusion comprises a calibration microneedle.

5. The replaceable microneedle array of claim 1, wherein the substrate further defines the at least one restoring spring element coupled between each microneedle and the substrate.

6. The replaceable microneedle array of claim 1, wherein the substrate further comprises a material selected from the group consisting of silicon, silicon dioxide, silicon nitride, plastic, metal, glass, quartz, sapphire, and a dielectric material.

7. The replaceable microneedle array of claim 1, wherein at least one of the plurality of moveable microneedles coated with at least one chemical sensing material comprises a plurality of regions of chemical sensing material.

8. The replaceable microneedle array of claim 7, wherein:

at least two of the plurality of regions comprise different chemical sensing materials from each other.

9. The replaceable microneedle array of claim 1, wherein the at least one chemical sensing material comprises a medium which changes color when in contact with a target chemical specie.

10. The replaceable microneedle array of claim 1, wherein the at least one chemical sensing material comprises a medium which fluoresces when in contact with a target chemical specie.

11. The replaceable microneedle array of claim 1, wherein the at least one chemical sensing material comprises a medium which changes its fluorescence characteristics when in contact with a target chemical specie.

12. The replaceable microneedle array of claim 1, wherein the at least one chemical sensing medium comprises a material selected from the group consisting of glucose oxidase, peroxidase, glucose dehydrogenase, hexokinase-glucokinase, rhenium bipyridine, boronic acid having fluorophores, NBD-fluorophores, europium teracycline, oxidizable color-change dyes such as 4-aminoantipyrine, chromotropic acid, and potassium iodide in the presence of a tri-iodide ion host such as amylose, starch, polyvinyl acetate, polyvinyl alcohol, polyvinyl pyrrolidone, nylon, cellulose, and chitosan.

13. The replaceable microneedle array of claim 1, wherein at least one of the plurality of moveable microneedles comprises a capillary film.

14. The replaceable microneedle array of claim 1, wherein at least one of the plurality of moveable microneedles comprises at least one roughened surface.

15. The replaceable microneedle array of claim 1, wherein at least one of the plurality of moveable microneedles comprises a semi-permeable membrane overlay.

16. The replaceable microneedle array of claim 1, wherein at least one of the plurality of moveable microneedles comprises micro-particulate diffuse particles.

17. The replaceable microneedle array of claim 1, further comprising a backside film opposite a microneedle facing side of the array and covering the wells;

and wherein;

the plurality of moveable microneedles are each coupled to the backside film; and

the backside film comprises the at least one restoring spring element coupled between each microneedle and the substrate.

18. The replaceable microneedle array of claim 1, wherein each of the microneedles comprises:

a metal needle embedded in a microneedle base defined by the substrate; and

a light-transmissive tapered structure surrounding at least a portion of the metal needle.