DEVICES AND METHODS FOR DELIVERY AND/OR WITHDRAWAL OF FLUIDS AND PRESERVATION OF WITHDRAWN FLUIDS

• US 20120271125A1
• Filed: 04/10/2012
• Published: 10/25/2012
• Est. Priority Date: 04/11/2011
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Bernstein, Howard, Blicharz, Timothy M.
• Application Number:
  US13/443,016
• Publication Number:
  US 20120271125A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/150175 Adjustment of penetration depth
• 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15119 comprising shape memory alloys
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles

Abstract

The present invention generally relates to systems and methods for delivering and/or withdrawing a substance or substances such as blood or interstitial fluid, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for withdrawing or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to withdraw blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus.

Claims

1. A device for withdrawing a fluid from the skin and/or from beneath the skin of a subject, the device comprising:

a deformable structure;

a fluid transporter fastened to a deformable portion of the deformable structure;

a sensor for determining at least one condition of the fluid withdrawn from the subject;

a signal generator for generating a signal relating to the fluid as determined by the sensor; and

a power source for powering at least the signal generator,

wherein the fluid transporter is used to cause the withdrawal of fluid from the subject, and wherein, when the device is applied to the surface of the skin of a subject and the structure is deformed, the fluid transporter is driven into or through the skin of the subject.

2. The device of claim 1, wherein the power source comprises a battery.

3. The device of claim 1, wherein the power source comprises a photovoltaic cell.

4. The device of claim 1, wherein the power source comprises a motor able to transform kinetic energy from the subject into electricity.

5. The device of claim 1, wherein the power source comprises a capacitor.

6. The device of claim 1, wherein the power source comprises a thermocouple and/or a thermoelectric generator.

18. The device of claim 1, wherein the signal comprises a visual signal.

19. The device of claim 1, wherein the signal comprises an electronic signal.

20. The device of claim 1, wherein the signal comprises a radio signal.

7-17. -17. (canceled)

21. A device for withdrawing a fluid from the skin and/or from beneath the skin of a subject, the device comprising:

a deformable structure;

a fluid transporter fastened to a deformable portion of the deformable structure; and

a fluidic network including a storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter,

wherein the fluidic network further comprises an agent able to stabilize a protein in the fluid withdrawn from the skin.

22. The device of claim 21, wherein the agent comprises a protease inhibitor.

23. The device of claim 22, wherein the protease inhibitor comprises one or more of sodium fluoride, sodium orthovanadate, a b-glycerophosphate, sodium pyrophosphate, 4-(2-aminoethyl)benzenesulfonyl fluoride hydrochloride, aprotinin, bestatin, E-64, ethylenediaminetetraacetic acid, leupeptin, pepstatin A, and/or phenylmethanesulfonylfluoride.

24. The device of claim 21, wherein the agent comprises a buffer.

25. The device of claim 24, wherein the buffer comprises citrate.

28. The device of claim 21, wherein the agent comprises a surfactant.

31. The device of claim 21, wherein the agent comprises a carbohydrate.

26-27. -27. (canceled)

29-30. -30. (canceled)

32-48. -48. (canceled)

49. A device for withdrawing a fluid from the skin and/or from beneath the skin of a subject, the device comprising:

a deformable structure;

a fluid transporter fastened to a deformable portion of the deformable structure; and

a fluidic network including a storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter,

wherein the fluidic network further comprises an agent able to stabilize a nucleic acid in the fluid withdrawn from the skin.

50. The device of claim 49, wherein the agent comprises ethylenediaminetetraacetic acid.

53. The device of claim 49, wherein the agent comprises a denaturant.

57. The device of claim 53, wherein the denaturant comprises beta-mercaptoethanol.

59. The device of claim 49, wherein the agent comprises an inorganic salt.

63. The device of claim 49, wherein the agent comprises an organic solvent.

68. The device of claim 49, wherein the agent comprises a detergent.

70. The device of claim 49, wherein the agent comprises a carbohydrate.

51-52. -52. (canceled)

54-56. -56. (canceled)

58. (canceled)

60-62. -62. (canceled)

64-67. -67. (canceled)

69. (canceled)

71-87. -87. (canceled)

88. A device for withdrawing a fluid from the skin and/or from beneath the skin of a subject, the device comprising:

a structure constructed and arranged to be positioned proximate the skin of the subject;

a fluid transporter associated with the support structure;

a storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter, and

a UV-inhibiting portion of the device positioned between the storage chamber and a source of UV radiation to which the device would be exposed in the normal course of using the device, comprising a blocking material able to block at least about 60% of ultraviolet light incident thereto.

90. The device of claim 88, wherein the blocking material is able to block at least about 95% of ultraviolet light incident thereto.

89. (canceled)

91-116. -116. (canceled)

117. A method, comprising:

applying a device to the skin of a subject, the device able to withdraw a fluid from the skin and/or from beneath the skin of the subject, the device comprising;

a support structure for application to the skin of the subject, and a fluid transporter associated with the support structure;

withdrawing the fluid from the skin and/or beneath the skin of the subject using the fluid transporter; and

transporting at least a portion of the device containing the withdrawn fluid to a secondary site for analysis, wherein the withdrawn fluid within the device is exposed during transport to a reduced pressure less than atmospheric pressure.

118-137. -137. (canceled)