RAPID DELIVERY AND/OR WITHDRAWAL OF FLUIDS

• US 20110251562A1
• Filed: 06/22/2011
• Published: 10/13/2011
• Est. Priority Date: 01/13/2010
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Davis, Shawn, Levinson, Douglas A., Haghgooie, Ramin, Chickering, Donald E. III, Bernstein, Howard, Michelman, Mark
• Application Number:
  US13/166,611
• Publication Number:
  US 20110251562A1
• Time in Patent Office: Days
• US Class Current: 604/173
• 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

1-148. -148. (canceled)

149. A device applicable to the skin of a subject, the device comprising:

a reversibly deformable structure; and

one or more needles, at least some of which comprise a coating, fastened to a deformable portion of the deformable structure,

wherein, when the device is applied to the surface of the skin of a subject and the structure is deformed, the one or more needles are driven into the skin of the subject.

150. The device of claim 149, wherein the coating comprises a drug.

151. The device of claim 149, wherein at least some of the one or more needles are microneedles.

152. The device of claim 149, wherein the reversibly deformable structure has a concave or convex shape.

153. The device of claim 149, wherein the reversibly deformable structure spontaneously returns to its original shape when a force is applied then released.

154. The device of claim 149, wherein the reversibly deformable structure is a snap dome.

155. The device of claim 149, wherein the reversibly deformable structure comprises a polymer.

156. The device of claim 149, wherein the reversibly deformable structure comprises a metal.

157. The device of claim 149, wherein the device is self-contained.

158. The device of claim 149, wherein the coating comprises heparin.

159. The device of claim 149, wherein the coating comprises an anticoagulant.

160. The device of claim 149, wherein the coating comprises an anti-inflammatory compound.

161. The device of claim 149, wherein the coating comprises an analgesic.

162. The device of claim 149, wherein the coating comprises an anti-histamine compound.

163. A device applicable to the skin of a subject, the device comprising:

a support structure; and

one or more needles, at least some of which comprise a coating, fastened to the support structure,

wherein the support structure is able to insert the one or more needles into the skin at a speed of at least about 1 cm/s.

164. The device of claim 163, wherein the support structure is able to insert the one or more needles into the skin at a speed of at least about 10 cm/s.

165. The device of claim 163, wherein the support structure comprises a reversibly deformable structure.

166. The device of claim 165, wherein the reversibly deformable structure is a snap dome.

167. The device of claim 165, wherein the reversibly deformable structure spontaneously returns to its original shape when a force is applied then released.

168. The device of claim 163, wherein at least a portion of the support structure has a concave or convex shape.