PATIENT-ENACTED SAMPLING TECHNIQUE

• US 20110125058A1
• Filed: 11/24/2010
• Published: 05/26/2011
• Est. Priority Date: 11/24/2009
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Haghgooie, Ramin, Chickering, Donald E. III, Davis, Shawn, Levinson, Douglas A., Bernstein, Howard
• Application Number:
  US12/953,744
• Publication Number:
  US 20110125058A1
• Time in Patent Office: Days
• US Class Current: 600/578
• 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. A method for obtaining a fluid sample from the skin and/or from beneath the skin of a subject, comprising:

providing a fluid access and storage device, comprising a fluid storage reservoir, to a non-healthcare-professional person;

directing the non-healthcare-professional person to use the device whereby, in the absence of a healthcare professional, the device is applied to the skin of the subject to obtain a fluid sample from the skin and/or from beneath the skin of the subject into the fluid storage reservoir of the device, and removed from the skin of the subject thereby defining a stored sample of fluid within the device; and

transporting the fluid storage reservoir including the stored sample of fluid to a clinical and/or laboratory setting.

6. The method of claim 1, wherein the device further comprises a support structure.

11. The method of claim 6, wherein the device further comprises a transport means for obtaining the sample from the skin and/or from beneath the skin of a subject, the transport means in fluidic communication with the reservoir.

15. The method of claim 11, wherein the transport means comprises a microneedle.

20. The method of claim 11, wherein the device is able to withdraw the transport means from the skin of the subject after exposure to the skin.

22. The method of claim 11, wherein the transport means is able to move within the device.

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

26. The method of claim 1, wherein the device comprises a self-contained vacuum chamber.

28. The method of claim 1, wherein the subject activates the device to obtain the sample using an activator.

2-5. -5. (canceled)

7-10. -10. (canceled)

12-14. -14. (canceled)

16-19. -19. (canceled)

21. (canceled)

23-24. -24. (canceled)

27. (canceled)

29-38. -38. (canceled)

39. A device for obtaining fluid from a subject, comprising:

a fluid transporter;

a fluid storage reservoir; and

an indicator of one or more conditions associated with the introduction of fluid into the storage reservoir and/or one or more conditions associated with the storage of fluid in the storage reservoir, wherein the indicator is activated upon the accessing of fluid by the fluid transporter and/or the introduction of fluid into the storage reservoir.

40-77. -77. (canceled)

78. A method, comprising:

providing a non-healthcare-professional person with a fluid access device;

directing the non-healthcare-professional person to apply the fluid access device to the skin of a subject to withdraw fluid from the skin and/or from beneath the skin of the subject into the device; and

directing the non-healthcare-professional person to cause transport at least a portion of the device containing the withdrawn fluid to a separate location for analysis.

80. The method of claim 78, wherein the fluid comprises blood.

81. The method of claim 78, wherein the non-healthcare-professional person is the subject.

82. The method of claim 78, comprising directing the non-healthcare-professional person to cause transport of a portion of the device.

83. The method of claim 78, comprising directing the non-healthcare-professional person to cause transport of the entire device.

84. The method of claim 78, comprising directing the non-healthcare-professional person to mail at least a portion of the device.

85. The method of claim 78, comprising directing the non-healthcare-professional person in a non-healthcare setting.

86. The method of claim 78, comprising providing instructions to the non-healthcare-professional person to direct the person.

87. The method of claim 86, comprising providing written instructions.

88. The method of claim 86, comprising providing instructions electronically.

79. (canceled)

89-91. -91. (canceled)