Devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications

• US 9,775,551 B2
• Filed: 07/13/2015
• Issued: 10/03/2017
• Est. Priority Date: 03/02/2009
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Bernstein, Howard, Chickering, III, Donald E., Levinson, Douglas A., Walt, David R., Davis, Shawn, Haghgooie, Ramin, Langer, Robert S., Blicharz, Timothy M.
• Primary Examiner(s): Blackman, Rochelle-Ann J
• Application Number:
  US14/797,421
• Publication Number:
  US 20150313522A1
• Time in Patent Office: 813 Days
• Field of Search: 600309, 600345, 600583, 600584, 604 20, 604 21
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/150022 for capillary blood or interstitial fluid
• 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 5/150221 Valves
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting 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 5/150969 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15125 : comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 : Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/4845 : Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/486 : Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: A61B 5/6898 : Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/743 : Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.

Claims

1. A device for withdrawing blood from the skin and/or from beneath the skin of a subject, the device comprising:

a recess;

a vacuum chamber separate from the recess having an internal pressure less than atmospheric pressure before blood is withdrawn into the device and before the device is applied to the skin of the subject;

a storage chamber, separate from the vacuum chamber and the recess, for receiving blood withdrawn into the recess when a negative pressure is applied to the skin of the subject; and

a sensor for determining a condition of the blood withdrawn into the device.

2. The device of claim 1, further comprising a microfluidic channel, discrete from the vacuum chamber and the storage chamber and having a smaller cross-sectional area than the cross-sectional area of the storage chamber, wherein the vacuum chamber is in fluid communication with the storage chamber via the microfluidic channel.

3. The device of claim 1, further comprising a plurality of microneedles for accessing the blood from and/or through the skin of the subject.

4. The device of claim 3, further comprising a support structure constructed and arranged to move the plurality of microneedles into contact with the skin, and to withdrawal the plurality of microneedles from the skin after contact with the skin.

5. The device of claim 1, further comprising a reaction entity contained within the storage chamber able to react with an analyte contained within the blood, wherein a product of the reaction entity reacted with the analyte is determinable by the sensor.

6. The device of claim 1, wherein the vacuum chamber does not have a variable volume.

7. The device of claim 1, further comprising a signal generator for generating a signal relating to the blood determined by the sensor.

8. The device of claim 1, further comprising a display able to display a result of the determination of the analyte by the sensor.

9. A device for withdrawing blood from the skin and/or from beneath the skin of a subject, the device comprising:

a vacuum chamber having an internal pressure less than atmospheric pressure before blood is withdrawn into the device and before the device is applied to the skin of the subject;

a storage chamber, separate from the vacuum chamber;

a microfluidic channel, discrete from the vacuum chamber and the storage chamber and having a smaller cross-sectional area than the cross-sectional area of the storage chamber;

a support structure constructed and arranged to be positioned proximate the skin of the subject;

a plurality of microneedles, associated with the support structure, for accessing blood from and/or through the skin of the subject; and

a sensor for determining a condition of the blood withdrawn into the device,

wherein the vacuum chamber is in fluid communication with the storage chamber via the microfluidic channel, and wherein the support structure is constructed and arranged to move the plurality of microneedles into contact with the skin, and to withdrawal the plurality of microneedles from the skin after contact with the skin.

10. The device of claim 9, wherein the support structure is able to apply a vacuum to the skin.

11. The device of claim 9, wherein the sensor is positioned to sense at least a portion of the storage chamber.

12. The device of claim 9, wherein the plurality of microneedles is able to move relative to the support structure.

13. The device of claim 9, wherein the plurality of microneedles comprises solid microneedles.

14. The device of claim 9, further comprising a signal generator for generating a signal relating to the blood determined by the sensor.

15. The device of claim 9, further comprising a display able to display a result of the determination of the analyte by the sensor.

16. The device of claim 9, further comprising a reaction entity able to react with an analyte contained within the blood, wherein a product of the reaction entity reacted with the analyte is determinable by the sensor.