SYSTEMS AND METHODS FOR CREATING AND USING SUCTION BLISTERS OR OTHER POOLED REGIONS OF FLUID WITHIN THE SKIN
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.
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.
3 - 6 . (canceled)
7 . The method of claim 1 , wherein the agent comprises a magnetically susceptible material.
8 - 10 . (canceled)
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.
16 - 22 . (canceled)
23 . The method of claim 1 , wherein the agent comprises a species able to bind glucose.
24 - 25 . (canceled)
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.
30 - 37 . (canceled)
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.
42 - 43 . (canceled)
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.
46 - 50 . (canceled)
51 . The method of claim 1 , wherein the pooled region of fluid has a volume of less than about 2 ml.
52 - 57 . (canceled)
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.
61 . (canceled)
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.
64 - 65 . (canceled)
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.
67 - 71 . (canceled)
72 . The method of claim 59 , wherein the device comprises a microneedle for delivery of the agent.
73 - 74 . (canceled)
75 . The method of claim 1 , wherein the subject is human.
76 - 78 . (canceled)
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.
82 - 86 . (canceled)
87 . The method of claim 1 , comprising delivering a plurality of agents into the pooled region of fluid.
88 - 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 . (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 . (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 . (canceled)
158 - 177 . (canceled)