Fluid extraction and drug delivery system and methods using microneedles

• US 10,542,922 B2
• Filed: 03/26/2014
• Issued: 01/28/2020
• Est. Priority Date: 03/26/2013
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Sia, Samuel K., Tejavibulya, Nalin
• Primary Examiner(s): Hindenburg, Max F
• Application Number:
  US14/779,556
• Publication Number:
  US 20160029937A1
• Time in Patent Office: 2,134 Days
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150755 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 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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 5/489 Blood vessels
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0046 : Solid microneedles
• CPC Class Codes: A61M 2037/0061 : Methods for using microneedles
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

Devices systems and methods for fluid extraction and delivery to human or animal hosts are described. In embodiments, microneedles are employed to provide low infection risk and painless access to and administration of fluids. The disclosed embodiments address, among others, issues of cost, portability, ease of use in remote settings including use by untrained personnel, and others.

Claims

1. A device for sampling fluid, comprising:

a first member having an array of microneedles and, coplanar therewith, an array of optical detectors, optical detectors of said array of optical detectors being adapted to detect hemoglobin in the body of a human or animal subject;

a controller configured to receive signals from the detectors and to calculate a position for insertion of a selected one of the microneedle responsively to the detector signals, the controller being configured to calculate said position either by itself or by conveying data to a remote computation device;

a drive motor arranged to move the first member to position the selected one of the microneedles responsively to said position for insertion;

a mechanism constructed to translate the selected one of the microneedles along an axis thereof such that the selected one of microneedles can be inserted in a human or animal subject.

2. The device of claim 1, further comprising a housing enclosing at least the first member and fitted with a retaining strap to permit the housing to be strapped to a human or animal subject.

3. The device of claim 1, wherein the first member is fitted with an extraction motor arranged to move the selected one of the microneedles along an axis thereof.

4. The device of claim 1, further comprising a second member, movable relative to the first, and carrying an extraction motor arranged to move the selected one of the microneedles along an axis thereof.

5. The device of claim 3, wherein the extraction motor is one of a linear motor and a thermoelectric motor.

6. The device of claim 1, where in the first member includes a network of channels and a sample chamber held under vacuum.

7. The device of claim 1, further comprising an infrared light source, wherein the first member includes a light guide shaped to output light at various points of an external surface coinciding with detectors of said array of detectors.

8. A system for extracting blood from a vein of a subject, the system comprising:

one or more microneedles;

an array of photodetectors to determine the location of the vein for the extraction of blood;

a motor operatively connected to the one or more microneedles to move the micro-needles; and

a controller configured to process a signal from the array of photodetectors and to operate the motor to move a selected microneedle of the one or more microneedles to the location of the vein for the extraction of blood;

a housing for mounting the one or more microneedles, the motor, the array of photodetectors, and the controller;

wherein the housing is constructed to be placed on the skin of the subject such that the one or more microneedles and the photodetector array face the skin but do not contact the skin;

the system further comprising an actuator for pushing the selected microneedle into the vein;

wherein the controller is configured to operate the actuator to push the selected microneedle into the vein after the selected microneedle is moved to the location of the vein.

9. The system of claim 8, wherein the selected microneedle is selected based on its proximity to the determined location of the vein.

10. The system of claim 8, wherein the actuator is movably mounted, the system comprising an actuator motor that moves the actuator to a position corresponding to the selected microneedle responsive to the controller.

11. The system of claim 8, wherein the one or more microneedles and the photodetector array are mounted on a first rotatable base, and the motor and controller are configured to cause the first rotatable base to rotate to move the selected microneedle to the location of the vein.

12. The system of claim 11, wherein the first rotatable base is ring-shaped, the system comprising a ring-shaped second rotatable base concentric with the first rotatable base, the second rotatable base having one or more microneedles and a photodetector array, and a second motor that rotates the second rotatable base;

wherein the controller is configured to process signals from the arrays of photodetectors of the first and second rotatable bases, to select the selected microneedle from the first and second rotatable bases, and to operate the motors to move the selected microneedle to the location of the vein.

13. The system of claim 8, wherein the one or more microneedles each are slidably mounted in the housing and biased to a retracted position away from the subject'"'"'s skin, and has a first end facing the subject'"'"'s skin and a second end facing into the housing, and

wherein the actuator comprises an electromagnet having a permanent magnet fixedly mounted in the housing above the second end of the selected microneedle, and a sample storage unit movably mounted between the second end and the electromagnet, the sample storage unit having a puncturable/sealable membrane maintaining a vacuum in the sample storage unit;

wherein in a non-sampling state, the permanent magnet of the electromagnet magnetically attracts the sample storage unit, and in a sampling state the electromagnet receives a signal from the controller for causing the electromagnet to repel the sample storage unit;

wherein in the sampling state, the sample storage unit is pushed against the selected microneedle to push the selected microneedle into the vein and puncture the membrane, whereby the vacuum draws blood through the needle and into the sample storage unit.

14. The system of claim 13, wherein the controller is configured to remove the signal from the electromagnet after the blood is drawn into the sample storage unit;

wherein each of the one or more microneedles has a spring for biasing the microneedle to the retracted position, and for returning the selected microneedle to the retracted position when the electromagnet is switched from the sampling state to the non-sampling state by the controller.

15. The system of claim 13, wherein an interior of the sample storage unit has a coating of an anticoagulant.

16. The system of claim 8, wherein the photodetectors detect infrared light, and the system comprises an infrared light source.

17. A device for sampling fluid, comprising:

a first member having an array of microneedles and an array of optical detectors, optical detectors of said array of optical detectors being constructed to detect hemoglobin in the body of a human or animal subject;

a controller configured to receive signals from the detectors and to calculate a position for insertion of a selected one of the microneedle responsively to the detector signals, the controller being configured to calculate said position either by itself or by receiving said position from a remote computation device;

a drive motor arranged to move the first member to position the selected one of the microneedles responsively to said position for insertion;

a mechanism for translating the selected one of the microneedles along an axis thereof such that the selected one of microneedles can be inserted in a human or animal subject.

18. The device of claim 17, further comprising a housing enclosing at least the first member and fitted with a retaining strap to permit the housing to be strapped to a human or animal subject.

19. The device of claim 17, wherein the first member is fitted with an extraction motor constructed to move the selected one of the microneedles along an axis thereof.

20. The device of claim 17, further comprising a second member, movable relative to the first, and carrying an extraction motor constructed to move the selected one of the microneedles along an axis thereof.

21. The device of claim 19, wherein the extraction motor is one of a linear motor and a thermoelectric motor.

22. The device of claim 17, wherein the first member includes a network of channels and a sample chamber held under vacuum.

23. The device of claim 17, further comprising an infrared light source, wherein the first member includes a light guide shaped to output light at various points of an external surface coinciding with detectors of said array of optical detectors.