PATIENT-ENACTED SAMPLING TECHNIQUE

• US 20150057510A1
• Filed: 10/14/2014
• Published: 02/26/2015
• Est. Priority Date: 11/24/2009
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Levinson, Douglas A., Bernstein, Howard, Chickering, Donald E. III, Davis, Shawn, Haghgooie, Ramin
• Application Number:
  US14/513,327
• Publication Number:
  US 20150057510A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150503 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 : comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15144 : comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15186 : Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/74 : Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention is generally directed to systems and methods for sampling fluids from subjects. The fluid may be any suitable bodily fluid, e.g., blood or interstitial fluid. In some cases, the subject is a patient. The subject may have a device that can be applied to the skin of the subject (e.g., by the subject, or another person), and the device is able to obtain a sample of fluid. The fluid may be stored within a reservoir in the device, and the fluid may be obtained from the subject at any convenient time, e.g., at home, away from a healthcare setting, etc. In some embodiments, the device, or a portion thereof, may be returned to a clinical and/or laboratory setting to analyze the fluid stored within the device.

Claims

1-91. -91. (canceled)

92. A device for receiving bodily fluid from a subject, the device comprising:

a fluid transporter comprising a microneedle;

a fluid storage reservoir in fluidic communication with the fluid transporter; and

an indicator indicative of the time fluid is contained within the fluid storage reservoir.

93. The device of claim 92, wherein the indicator is able to record the time when fluid enters the fluid storage reservoir.

94. The device of claim 92, wherein the indicator is able to record the duration fluid is present within the fluid storage reservoir.

95. The device of claim 92, wherein the indicator is able to produce a signal indicative of a condition of fluid within the fluid storage reservoir.

96. The device of claim 95, wherein the signal includes a visual signal.

97. The device of claim 95, wherein the signal includes a color signal.

98. The device of claim 92, wherein the indicator is activated upon activation of the device.

99. The device of claim 92, wherein the indicator is activated upon introduction of fluid into the fluid storage reservoir.

100. The device of claim 92, wherein the indicator is in electronic communication with a sensor in sensing communication with the fluid storage reservoir.

101. The device of claim 92, wherein the device is able to apply a vacuum to the subject to withdraw fluid into the fluid storage reservoir.

102. The device of claim 92, wherein the device further comprises a self-contained vacuum chamber in fluidic communication with the fluid storage reservoir.

103. The device of claim 92, wherein the device further comprises an activator able to activate withdrawal of fluid from the subject into the fluid storage reservoir.

104. The device of claim 103, wherein the activator is activated by pressing a button on the device.

105. The device of claim 103, wherein the activator is activated upon applying the device to the skin of the subject.

106. The device of claim 103, wherein the activator is activated upon removal of the device from packaging containing the device.

107. The device of claim 92, wherein the device is able to determine an analyte contained within fluid from the skin and/or from beneath the skin of the subject into the fluid storage reservoir.

108. The device of claim 107, wherein the fluid comprises blood.

109. The device of claim 107, wherein the fluid comprises interstitial fluid.

110. The device of claim 92, wherein the device further comprises an anticoagulant for fluid from the subject.

111. The device of claim 92, wherein the device comprises a first module and a second module, wherein the first module comprises a support structure comprising the fluid transporter and the fluid storage reservoir, and the second module comprises a signal structure comprising the indicator.

112. The device of claim 111, wherein the first module and the second module are constructed and arranged to be disconnectable without the use of tools.