DEVICES AND TECHNIQUES ASSOCIATED WITH DIAGNOSTICS, THERAPIES, AND OTHER APPLICATIONS, INCLUDING SKIN-ASSOCIATED APPLICATIONS

• US 20100256465A1
• Filed: 03/02/2010
• Published: 10/07/2010
• Est. Priority Date: 03/02/2009
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Blicharz, Timothy M., Langer, Robert S., Davis, Shawn, Levinson, Douglas A., Haghgooie, Ramin, Walt, David R., Chickering, Donald E. III, Bernstein, Howard
• Granted Patent: US 9,113,836 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 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 analysis of an extractable medium from a subject, the device comprising:

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

means associated with the support structure for accessing the extractable medium from and/or through the skin of the subject at an access site;

a pressure regulator supported by the support structure, able to create a pressure differential across the skin at least a portion of the access site;

a sensor supported by the support structure, for determining at least one condition of the extractable medium from the subject; and

a signal generator supported by the support structure, for generating a signal relating to the condition of the medium determined by the sensor.

2. The device of claim 1, including an adhesive for adhesion of the support structure to the skin.

3. The device of claim 1, further comprising an extraction activator associated with the support structure which activates the means for accessing the extractable medium, thereby extracting the medium from or through the skin of the subject.

4. The device of claim 3, wherein the extraction activator is placeable against the skin.

5. The device of claim 3, wherein the extraction activator is able to determine a force created when the device is placed against the skin.

6. The device of claim 1, wherein the support structure further comprises a mechanical element for affixing the device to the skin.

7. The device of claim 1, wherein the support structure contains a recess containing the means for accessing the extractable medium.

8. The device of claim 1, wherein the support structure further comprises a microfluidic channel in fluidic communication with the extraction activator.

9. The device of claim 1, wherein the device is able to withdraw fluid from the subject.

10. The device of claim 9, wherein the fluid comprises blood.

11. The device of claim 9, wherein the fluid comprises interstitial fluid.

12. The device of claim 9, wherein the device further comprises a storage compartment in fluidic communication with the means for accessing the extractable medium.

13. The device of claim 1, wherein the device is able to determine an analyte contained within fluid withdrawn from the subject.

14. The device of claim 13, wherein the device is able to determine the analyte without subsequent removal of the device from the skin of the subject.

15. The device of claim 13, wherein the device is able to automatically determine the analyte.

16. The device of claim 13, wherein the device is able to display a result of the determination of the analyte.

17. The device of claim 1, wherein the device is able to deliver fluid to the subject via the means for accessing the extractable medium.

18. The device of claim 1, wherein the means for accessing the extractable medium comprises one or more microneedles.

19. The device of claim 1, wherein the means for accessing the extractable medium comprises one or more solid microneedles.

20. The device of claim 1, wherein the means for accessing the extractable medium comprises one or more hollow microneedles.

21. The device of claim 1, wherein the means for accessing the extractable medium is immobilized relative to the support structure.

22. The device of claim 1, wherein the device is able to withdraw the means for accessing the extractable medium from the skin after exposure to the skin.

23. The device of claim 1, wherein the support structure is able to draw the skin of the subject towards the means for accessing the extractable medium.

24. The device of claim 1, wherein the support structure is able to apply a vacuum to the skin.

25. The device of claim 1, wherein the support structure comprises a self-contained vacuum chamber.

26. The device of claim 1, wherein the means for accessing the extractable medium is able to move relative to the support structure.

27. The device of claim 1, wherein the means for accessing the extractable medium is activatable by the subject.

28. The device of claim 1, wherein the means for accessing the extractable medium is activated upon applying the device to the skin.

29. The device of claim 1, the device further comprising a heater for applying heat to the skin.

30. The device of claim 1, the device further comprising a cooler for cooling the skin.

31. A device for analysis of an extractable medium from a subject, the device comprising:

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

a fluid transporter for accessing the extractable medium from and/or through the skin of the subject at an access site;

a pressure regulator supported by the support structure, able to create a pressure differential across the skin at least a portion of the access site;

a sensor supported by the support structure, for determining at least one condition of the extractable medium from the subject; and

a signal generator supported by the support structure, for generating a signal relating to the condition of the medium determined by the sensor.

32. A device for analysis of an extractable medium from a subject, the device comprising:

means for accessing the extractable medium from and/or through the skin of the subject at an access site;

a pressure regulator, able to create a pressure differential across the skin at least a portion of the access site;

a sensor for determining at least one condition of the extractable medium from the subject; and

a signal generator for generating a signal relating to the condition of the medium determined by the sensor.

33. A device for analysis of an extractable medium from a subject, the device comprising:

means for accessing the extractable medium from skin and/or from beneath the skin of the subject at an access site;

a pressure differential chamber able to create a pressure differential across the skin in at least a portion of the access site in the absence of a piston pump associated with the chamber;

a sensor for determining at least one condition of the extractable medium from the subject; and

a signal generator for generating a signal relating to the condition of the medium determined by the sensor.

34. A method for analyzing an extractable medium from a subject, comprising:

positioning an analysis device, comprising a pathway, adjacent the skin of the subject and, while the device is adjacent the skin;

activating an access component of the device to connect the extractable medium with the pathway of the device;

activating a pressure controller of the device to urge the extractable medium into the device via the pathway;

exposing the medium to a sensor of the device and determining at least one condition of the extractable medium from the subject; and

generating a signal relating to the condition of the medium determined by the sensor.

35. A device applicable to a site proximate the skin of a subject, comprising:

an agent that reacts or interacts with an analyte to be detected and generates a signal that can be detected visually, by feel, by smell, or by taste,

wherein the agent that reacts with or interacts with an analyte and the signaling agent can be the same or different, and

wherein the signal can vary as a function of an attribute of the analyte, producing a signal that can be analyzed qualitatively.

36. A device applicable to a site proximate the skin of a subject, comprising:

an agent that reacts or interacts with an analyte to be detected and generates a signal that can be detected visually, by feel, by smell, or by taste,

wherein the agent that reacts or interacts with an analyte and the signaling agent can be the same or different, and

wherein the device acquires fluid from the subject and transports the fluid from a site of acquisition to a site of analysis for reaction.

37. A device applicable to a site proximate the skin of a subject, wherein the device determines a physical condition of a subject and produces a signal related to the condition, the signal not readily understandable by the subject.

38. A method, comprising:

providing a device at a site proximate the skin of a subject, wherein the device determines a physical condition of a subject and produces a signal related to the condition;

acquiring a representation of the signal; and

transporting the representation of the signal to an entity that analyzes the representation.

39. A method comprising:

providing a plurality of analysis sites proximate the skin of a subject, including at least a first analysis site that generates a first signal related to a first physical condition of the subject and a second analysis site that generates a second signal related to a second physical condition of the subject.

40. A method comprising:

providing a reaction site proximate the skin of a subject comprising a reactive agent that reacts or interacts with an analyte to generate an signal in the form of an icon.

41. A device applicable to a site proximate the skin of a subject to determine a condition of the subject, comprising:

a first component and a second component connected to the first component for application to the site and separable from the first component after application to the site, wherein the first component can be activated to acquire a bodily fluid of the subject, and the second component comprises an agent that reacts or interacts with an analyte to be detected and generates a signal that can be detected visually, by feel, by smell, or by taste.

42. A device wearable by a subject, comprising an agent that reacts or interacts with an analyte in saliva of the subject to generate a signal.

43. A device applicable to a site proximate the skin of a subject, the device comprising an agent that reacts or interacts with an analyte to be detected to generate a signal that can be detected visually, by feel, by smell, or by taste,

wherein the device comprises a membrane comprising the agent that participates in generation of the signal, the membrane being selective to one or more of passage of an analyte and/or an analyte indicator, and reaction with an analyte and/or an analyte indicator.

44. A method comprising applying, proximate the skin of a subject in need of emergency care, a device comprising a reactive agent that reacts or interacts with an analyte to generate a signal indicative of a condition of the subject.

45. A method, comprising:

applying, to a solution containing a plurality of first particles of a first color and a plurality of second particles of a second color, an electric field and/or a magnetic field sufficient to cause a change in color of the solution.

46. A method comprising:

exposing, to a sample, a population of particles including at least a first sub-population having a first determinable characteristic and a second sub-population having a second determinable characteristic;

allowing at least some particles of the first sub-population of particles to bind a component of the sample via a binding partner, wherein the second sub-population of particles remains essentially unbound to the component, such that the ratio of the number of particles from the first sub-population bound to the component, to the number of particles from the second sub-population bound to the component, is at least 5;

1;

separating the particles bound to the component from those not bound; and

determining a characteristic of the sample by determining the separation.

47. A method comprising:

determining a characteristic of a sample by visualizing a color change effected by a change in population of particles of different color upon preferential binding of particles of one color to a component of the sample via a binding partner.