COMPOSITIONS AND METHODS FOR RAPID ONE-STEP DIAGNOSIS

• US 20100069726A1
• Filed: 06/04/2009
• Published: 03/18/2010
• Est. Priority Date: 06/04/2008
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Levinson, Douglas A.
• Application Number:
  US12/478,756
• Publication Number:
  US 20100069726A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

Devices for fast easy monitoring of analyte levels, disease, or other physiological changes are provided. In some cases, the devices may include particles or the like that can be placed and read at the site of detection, typically on or in the skin or mucosa. In one embodiment, the particles may include anisotropic particles. Typically the devices will typically provide a visual colorimetic signal, but other signals are possible, such as smell, taste (e.g., release of food acceptable flavor), or tactile (e.g., shape change). The devices are preferably single use, disposable devices, although some may be able to provide multiple readings over a period of time. These devices may be used with any patient and are particularly useful for pediatric and elderly patients, as well as for the military, and people without health insurance. The devices can be used to assess when intervention may be required without expensive testing at a physician'"'"'s office, or simply for routine maintenance of those who are concerned about their health.

Claims

1. A single step diagnostic device for determination of the presence and/or amount of an analyte in a subject, wherein

the device is in a form suitable for administration topically, under or within the skin or mucosal surface,

and wherein the device comprises

a reactive agent that reacts with or interacts with an analyte to be detected at the site of administration, and

a signaling agent which, alone and/or in combination with another species, generates a signal that can be detected visually, by feel, by smell, or by taste, at the site of reaction with the analyte, wherein the reactive agent and the signaling agent may be the same or different.

2-16. -16. (canceled)

17. A method of determining the presence or amount of analyte comprising administering to a subject topically, under or within the skin or mucosal surface to the site where analyte is to be measured

a single step diagnostic device for determination of the presence and/or amount of an analyte in the subject, wherein

the device comprises

a reactive agent that reacts with an analyte to be detected at the site of administration and

a signaling agent, which, alone and/or in combination with another species, generates a signal that can be detected visually, by feel, by smell, or by taste, at the site of reaction with the analyte, without reference to an external or secondary device or reference sample.

18-22. -22. (canceled)

23. A method of determining a target indicative of an analyte, comprising:

exposing the target to a group of particles, at least some particles of the group of particles having at least two distinct surface regions including at least a first surface region and a second surface region, wherein the first surface region is able to fasten the target;

fastening the first surface region of the at least some particles to the analyte to cause a change in particle orientation; and

determining a determinable feature of the particles, thereby determining the target, to determine the analyte.

24-70. -70. (canceled)

71. A method, comprising:

delivering particles, suitable for determining an analyte within the skin of a subject for a period of time of at least about a 15 minutes to the skin of the subject via a plurality of skin insertion objects.

72-82. -82. (canceled)

83. A method, comprising:

administering, into the skin of a subject, particles having at least two distinct regions, each region being present on the surface of the particles.

84-85. -85. (canceled)

86. A diagnostic sensor composition foreign to a subject, constructed to be resident in the epidermis of the subject to an extent greater than in the dermis of the subject, the composition responsive to an analyte so as to produce a detectable signal in the presence of the analyte distinguishable from a signal in the absence of the analyte.

87-92. -92. (canceled)

93. A method, comprising:

determining a physical condition of a subject by determining the visual appearance of a material located in the skin of the subject.

94-97. -97. (canceled)

98. A composition, comprising:

a temporary tattoo positioned primarily within the epidermis.

99-101. -101. (canceled)

102. A temporary, fully integrated continuous sensor on or in the skin that provides a sensory signal determinable by a user without the aid of external equipment.

103. (canceled)