RAPID DELIVERY AND/OR WITHDRAWAL OF FLUIDS

• US 20110172510A1
• Filed: 01/13/2011
• Published: 07/14/2011
• Est. Priority Date: 01/13/2010
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Michelman, Mark, Davis, Shawn, Levinson, Douglas A., Haghgooie, Ramin, Chickering, Donald E. III, Bernstein, Howard
• Application Number:
  US13/006,177
• Publication Number:
  US 20110172510A1
• Time in Patent Office: Days
• US Class Current: 600/317
• 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 5/150389 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 5/15125 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 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 5/685 : 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. For example, blood may be withdrawn from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. Other aspects of the present invention are directed at other devices for withdrawing blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Claims

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

a reversibly deformable structure;

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

a storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter,

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 the skin of the subject.

2. The device of claim 1, wherein the reversibly deformable structure has a concave or convex shape.

3. The device of claim 1, wherein the fluid transporter comprises one or more microneedles.

4. The device of claim 3, wherein at least some of the microneedles are solid.

5. The device of claim 3, wherein at least some of the microneedles are hollow.

6. The device of claim 1, wherein the reversibly deformable structure spontaneously returns to its original shape when a force is applied then released.

8. The device of claim 1, wherein the reversibly deformable structure comprises a metal.

9. The device of claim 1, wherein the storage chamber has an internal pressure less than atmospheric pressure prior to receiving the fluid.

10. The device of claim 1, wherein the fluid withdrawn from the subject comprises blood.

7. (canceled)

11-25. -25. (canceled)

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

a plurality of skin insertion objects for insertion into the skin of a subject, having a pre-deployed position and a deployed position; and

a reversibly deformable structure, operably linkable to the plurality of skin insertion objects, the reversibly deformable structure switchable from a first stable configuration, through an unstable configuration, to a second stable configuration, wherein in the first stable configuration, the skin insertion objects are not contactable with the skin of the subject, and in the second stable configuration, the skin insertion objects are insertable in the skin of the subject.

42. The device of claim 26, comprising at least 3 but no more than 5 skin insertion objects.

43. The device of claim 26, comprising at least 6 but no more than 10 skin insertion objects.

44. The device of claim 26, comprising at least 11 but no more than 20 skin insertion objects.

27-37. -37. (canceled)

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

a plurality of skin insertion objects for insertion into the skin of a subject, having a pre-deployed position and a deployed position, each of the skin insertion objects protruding from a base and defining a length from the base, and the plurality of skin insertion objects defining an average length of no more than 1,000 microns; and

a triggering mechanism able to move the skin insertion objects a fully pre-deployed position to a fully deployed position with a force sufficient to insert the plurality of skin insertion objects into or through the skin to an average depth of at least 60% the average length of the plurality of skin insertion objects.

39. The device of claim 38, wherein the depth of insertion is at least 70% the average length of the plurality of skin insertion objects.

40. The device of claim 38, wherein the depth of insertion is at least 80% the average length of the plurality of skin insertion objects.

41. The device of claim 38, wherein the depth of insertion is at least 90% the average length of the plurality of skin insertion objects.

45-49. -49. (canceled)

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

a fluid transporter;

a vacuum chamber having an internal pressure less than atmospheric pressure before a fluid is withdrawn into the device; and

a storage chamber, separate from the vacuum chamber, for receiving the fluid withdrawn from the subject via the fluid transporter when a negative pressure is applied to the skin of the subject.

52. The device of claim 50, wherein the storage chamber is separated from the vacuum chamber by a membrane.

53. The device of claim 52, wherein the membrane is hydrophilic.

54. The device of claim 52, wherein the membrane is hydrophobic.

55. The device of claim 50, wherein the storage chamber is separated from the vacuum chamber by a porous structure.

56. The device of claim 50, wherein the storage chamber is separated from the vacuum chamber by a dissolvable interface.

57. The device of claim 50, wherein the fluid transporter comprises one or more microneedles.

51. (canceled)

58-88. -88. (canceled)

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

a fluid transporter;

a first storage chamber for receiving a fluid withdrawn from the subject via the fluid transporter, the storage chamber having an internal pressure less than atmospheric pressure prior to receiving the fluid; and

a reaction entity contained within the first storage chamber able to react with an analyte contained within the fluid, wherein a product of the reaction entity with the analyte is determinable.

91. The device of claim 89, wherein the product is determinable by an external apparatus able to analyze at least a portion of the device.

92. The device of claim 89, wherein the product of the reactive species with the analyte is determinable as a change in fluorescence.

93. The device of claim 89, wherein the product of the reactive species with the analyte is determinable as a change in an electrical property.

94. The device of claim 89, wherein the product of the reactive species with the analyte is determinable as a change in an optical property.

95. The device of claim 89, wherein the analyte includes glucose.

96. The device of claim 89, wherein the analyte includes oxygen.

97. The device of claim 89, wherein the analyte is an ion.

98. The device of claim 89, wherein the reaction entity includes an antibody.

99. The device of claim 89, wherein the reaction entity includes a protein.

100. The device of claim 89, wherein the reaction entity includes an enzyme.

90. (canceled)

101-115. -115. (canceled)

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

a fluid transporter for receiving fluid from the subject;

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

an exit port for removing the fluid from the device, separate from the fluid transporter.

117-148. -148. (canceled)