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

• US 9,113,836 B2
• Filed: 03/02/2010
• Issued: 08/25/2015
• Est. Priority Date: 03/02/2009
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Bernstein, Howard, Chickering, Donald E. III, Levinson, Douglas A., Walt, David R., Davis, Shawn, Haghgooie, Ramin
• Primary Examiner(s): BLACKMAN, ROCHELLE ANN J
• Application Number:
  US12/716,229
• Publication Number:
  US 20100256465A1
• Time in Patent Office: 2,002 Days
• Field of Search: 600/309, 600/345, 600/583, 600/584, 604/20, 604/21
• US Class Current: 1/1
• 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 the skin and/or from beneath the skin of a subject, the device comprising:

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 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 at least a portion of the access site, wherein the pressure regulator comprises a vacuum chamber having an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject;

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

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

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.

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 plurality of microneedles, 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 3, wherein the support structure further comprises a microfluidic channel in fluidic communication with the extraction activator.

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

8. The device of claim 1, wherein the support structure contains a recess containing the plurality of microneedles.

9. The device of claim 8, further comprising a controller for fluidly communicating the vacuum chamber with the recess.

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

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

12. The device of claim 10, wherein the fluid comprises interstitial fluid.

13. The device of claim 10, wherein the device further comprises a storage compartment in fluidic communication with the plurality of microneedles.

14. The device of claim 13, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the storage compartment.

15. The device of claim 14, wherein the microfluidic channel has a smaller cross-sectional area than the storage compartment.

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

17. The device of claim 16, wherein the device is able to determine the analyte without subsequent removal of the device from the skin of the subject.

18. The device of claim 16, wherein the device is able to automatically determine the analyte.

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

20. The device of claim 1, wherein the device is able to deliver fluid to the subject via the plurality of microneedles.

21. The device of claim 1, wherein the plurality of microneedles comprises one or more solid microneedles.

22. The device of claim 1, wherein the plurality of microneedles comprises one or more hollow microneedles.

23. The device of claim 1, wherein the plurality of microneedles is immobilized relative to the support structure.

24. The device of claim 1, wherein the support structure is able to draw the skin of the subject towards the plurality of microneedles.

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

26. The device of claim 1, wherein the plurality of microneedles is able to move relative to the support structure.

27. The device of claim 1, wherein the plurality of microneedles is activatable by the subject.

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

32. A device for analysis of an extractable medium from the skin and/or from beneath the skin of 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, wherein the fluid transporter comprises a plurality of microneedles;

a pressure regulator supported by the support structure, able to create a pressure differential across the skin at at least a portion of the access site, wherein the pressure regulator comprises a vacuum chamber having an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject;

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,

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.

33. The device of claim 32, wherein the support structure contains a recess containing the plurality of microneedles.

34. The device of claim 33, further comprising a controller for fluidly communicating the vacuum chamber with the recess.

35. The device of claim 33, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the recess.

36. The device of claim 32, wherein the device further comprises a storage compartment, separate from the vacuum chamber, in fluidic communication with the plurality of microneedles.

37. The device of claim 36, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the storage compartment.

38. The device of claim 37, wherein the microfluidic channel has a smaller cross-sectional area than the storage compartment.

39. A device for analysis of an extractable medium from the skin and/or from beneath the skin of a subject, the device comprising:

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

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;

a pressure regulator, able to create a pressure differential across the skin at at least a portion of the access site, wherein the pressure regulator comprises a vacuum chamber having an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject;

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.

40. The device of claim 39, wherein the support structure contains a recess containing the plurality of microneedles.

41. The device of claim 40, further comprising a controller for fluidly communicating the vacuum chamber with the recess.

42. The device of claim 40, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the recess.

43. The device of claim 39, wherein the device further comprises a storage compartment, separate from the vacuum chamber, in fluidic communication with the plurality of microneedles.

44. The device of claim 43, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the storage compartment.

45. The device of claim 44, wherein the microfluidic channel has a smaller cross-sectional area than the storage compartment.

46. A device for analysis of an extractable medium from the skin and/or from beneath the skin of a subject, the device comprising:

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

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;

a vacuum 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, wherein the vacuum chamber has an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject;

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.

47. The device of claim 46, wherein the support structure contains a recess containing the plurality of microneedles.

48. The device of claim 47, further comprising a controller for fluidly communicating the vacuum chamber with the recess.

49. The device of claim 47, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the recess.

50. The device of claim 46, wherein the device further comprises a storage compartment, separate from the vacuum chamber, in fluidic communication with the plurality of microneedles.

51. The device of claim 50, further comprising a microfluidic channel fluidly communicating the vacuum chamber with the storage compartment.

52. The device of claim 51, wherein the microfluidic channel has a smaller cross-sectional area than the storage compartment.

53. A method for analyzing an extractable medium from the skin and/or from beneath the skin of 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 using a plurality of microneedles, wherein the device moves the plurality of microneedles into the skin of the subject and withdraws the plurality of microneedles from the skin of the subject after contacting the plurality of microneedles with the skin;

activating a pressure controller of the device to urge the extractable medium into the device via the pathway, wherein the pressure controller comprises a vacuum chamber having an internal pressure less than atmospheric pressure before the device is applied to the skin of the subject;

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

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

54. The method of claim 53, wherein activating a pressure controller comprises activating the pressure controller to urge the extractable medium via the pathway into a storage compartment within the device, wherein the storage compartment is separate from the vacuum chamber.

55. The method of claim 53, wherein the pathway comprises a microfluidic channel.