SYSTEMS AND METHODS FOR CREATING AND USING SUCTION BLISTERS OR OTHER POOLED REGIONS OF FLUID WITHIN THE SKIN

• US 20110009847A1
• Filed: 03/02/2010
• Published: 01/13/2011
• Est. Priority Date: 03/02/2009
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Anderson, Richard Rox, Bernstein, Howard, Levinson, Douglas A.
• Application Number:
  US12/716,233
• Publication Number:
  US 20110009847A1
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 method, comprising:

causing formation of a pooled region of fluid between the dermis and epidermis of the skin of a subject; and

delivering an agent into the pooled region of fluid for indication of a present and/or future condition of the subject.

2. The method of claim 1, wherein the agent comprises one or more particle.

7. The method of claim 1, wherein the agent comprises a magnetically susceptible material.

11. The method of claim 1, wherein the agent contains at least two distinct surface regions including at least a first surface region and a second surface region.

12. The method of claim 1, wherein the agent is responsive to a condition external of the subject.

13. The method of claim 1, wherein the agent is responsive to a marker of a disease state.

14. The method of claim 1, wherein the agent comprises a binding partner to an analyte, the analyte being indicative of the present and/or future condition of the subject.

15. The method of claim 14, wherein the binding partner is present on a first surface region of the agent but not a second surface region of the agent.

23. The method of claim 1, wherein the agent comprises a species able to bind glucose.

26. The method of claim 1, wherein the agent comprises a diagnostic agent.

27. The method of claim 1, wherein the agent comprises a therapeutic agent.

28. The method of claim 1, wherein the pooled region is formed by applying vacuum to the skin of the subject.

29. The method of claim 1, wherein the vacuum is self-contained on the device.

38. The method of claim 1, wherein the vacuum is applied for at least about 15 min.

39. The method of claim 38, wherein the vacuum is applied for at least about 30 min.

40. The method of claim 39, wherein the vacuum is applied for at least about 45 min.

41. The method of claim 40, wherein the vacuum is applied for at least about 1 hour.

44. The method of claim 1, further comprising causing at least a portion of the fluid within the pooled region of fluid to drain.

45. The method of claim 1, further comprising removing at least a portion of the fluid from the pooled region.

51. The method of claim 1, wherein the pooled region of fluid has a volume of less than about 2 ml.

58. The method of claim 1, comprising producing a suction blister in the skin of the subject that contains the pooled region of fluid.

59. The method of claim 1, comprising applying a device on the skin to cause the formation of the pooled region.

60. The method of claim 59, wherein the device comprises a vacuum source.

62. The method of claim 60, wherein the vacuum source is external to the device.

63. The method of claim 60, wherein the vacuum source is pre-packaged in the device.

66. The method of claim 59, wherein the device comprises an interface able to apply vacuum to the skin, wherein the interface has a diameter of less than about 5 cm.

72. The method of claim 59, wherein the device comprises a microneedle for delivery of the agent.

75. The method of claim 1, wherein the subject is human.

79. The method of claim 1, wherein the fluid comprises interstitial fluid.

80. The method of claim 1, wherein the condition is a present condition.

81. The method of claim 1, wherein the condition is a future condition.

87. The method of claim 1, comprising delivering a plurality of agents into the pooled region of fluid.

3-6. -6. (canceled)

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24-25. -25. (canceled)

30-37. -37. (canceled)

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52-57. -57. (canceled)

61. (canceled)

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67-71. -71. (canceled)

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76-78. -78. (canceled)

82-86. -86. (canceled)

88-89. -89. (canceled)

90. A method, comprising:

causing formation of a pooled region of fluid between the dermis and epidermis of the skin of a subject;

removing at least a portion of the fluid from the pooled region; and

analyzing at least a portion of the removed fluid thereby determining a present and/or future condition of the subject by exposing the fluid to an agent.

91-123. -123. (canceled)

124. A device applicable to the skin for determining an analyte in a subject, the device comprising:

a first portion able to create a pooled region of fluid within the skin of a subject; and

a second portion able to determine fluid of the pooled region of fluid.

125-150. -150. (canceled)

151. A device applicable to the skin for determining an analyte in a subject, the device comprising:

a first portion able to create a pooled region of fluid within the skin of a subject; and

a microfluidic channel in fluidic communication with the first portion.

152-157. -157. (canceled)

158-177. -177. (canceled)