SYSTEMS AND METHODS FOR APPLICATION TO SKIN AND CONTROL OF ACTUATION, DELIVERY, AND/OR PERCEPTION THEREOF

• US 20110105872A1
• Filed: 10/29/2010
• Published: 05/05/2011
• Est. Priority Date: 10/30/2009
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Davis, Shawn, Levinson, Douglas A., Haghgooie, Ramin, Walt, David R., Chickering, Donald E. III, Bernstein, Howard
• Application Number:
  US12/915,735
• Publication Number:
  US 20110105872A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150106 Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
• CPC Class Codes: A61B 5/150122 by heating
• CPC Class Codes: A61B 5/150129 by cooling
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• 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 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/685 : Microneedles
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 : having a lumen
• CPC Class Codes: A61M 2037/0046 : Solid microneedles
• CPC Class Codes: A61M 2037/0061 : Methods for using microneedles
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/588 : by olfactory feedback, i.e. smell
• CPC Class Codes: A61M 35/00 : Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/425 : Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

The present invention generally relates, in certain aspects, to systems and methods for application to the skin, and control of actuation, delivery, and/or perception thereof. For example, certain aspects of the invention are generally directed to devices for delivering to and/or withdrawing fluid or from subjects, e.g., to or from the skin and/or beneath the skin. In one aspect, the delivery and/or withdrawal of fluid is at least partially obscured. For example, the obscuration may be by time, and/or by sensory obscuration (e.g., by providing tactile, olfactory, auditory, and/or visual sensations). Certain aspects of the invention are generally directed to devices able to automatically deliver to and/or withdraw fluid from the skin and/or beneath the skin after activation, e.g., where the fluid is delivered and/or withdrawn without the need for any additional intervention. The devices may be activated by any suitable technique. In other aspects, a device may be contained in a package, and when removed from the package, the device may be constructed and arranged to be able to deliver and/or withdraw fluid when the device is applied to the skin, and in some cases, automatically and/or without any further intervention by the subject or another person.

Claims

1-35. -35. (canceled)

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

a support structure for application to the skin of the subject;

a fluid transporter associated with the support structure;

an extraction activator associated with the support structure able to activate the fluid transporter to extract the fluid from the skin and/or from beneath the skin of the subject; and

a sensory obscurer for producing a tactile, olfactory, auditory, and/or visual sensation able to at least partially obscure sensation produced by the fluid transporter.

37. The device of claim 36, wherein the support structure further comprises an adhesive for adhesion of the support structure to the skin of the subject.

43. The device of claim 36, wherein the extraction activator is able to be activated remotely.

44. The device of claim 36, wherein the extraction activator comprises a timing mechanism for timed activation of the extraction activator after removal from packaging containing the device.

38-42. -42. (canceled)

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

a support structure for application to the skin of the subject;

a fluid transporter associated with the support structure;

an extraction activator associated with the support structure able to activate the fluid transporter to extract the fluid from the skin and/or from beneath the skin of the subject; and

an applicator positioned to apply an analgesic to the skin of the subject.

46-146. -146. (canceled)

147. A device for multiple analyses of a fluid withdrawn from the skin of a subject, comprising:

a plurality of means for extracting a fluid from the skin and/or from beneath the skin of the subject,

wherein the plurality of means for extracting are initially fastened to the device and/or each other for use with a first extraction and, after first extraction and removal of the device from the skin of the subject, one means for extracting is removed from the device.

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

a support structure for application to the skin of the subject;

a fluid transporter associated with the support structure; and

an extraction activator associated with the support structure able to activate the fluid transporter to extract the fluid from the skin and/or from beneath the skin of the subject,

wherein the extraction activator is constructed and arranged to activate the fluid transporter by application of the support structure to the skin of the subject, and/or by one-time manipulation of an actuator, whereby extraction of the fluid is completed without additional manipulation of the extraction activator.

149. The device of claim 148, wherein the support structure further comprises an adhesive for adhesion of the support structure to the skin of the subject.

159. The device of claim 148, wherein the fluid comprises blood.

161. The device of claim 148, wherein the device further comprises a storage chamber in fluidic communication with the extraction activator.

162. The device of claim 148, wherein the device is able to determine an analyte contained within the fluid.

164. The device of claim 162, wherein the device is able to automatically determine the analyte.

165. The device of claim 162, wherein the device is able to display a result of the determination of the analyte.

166. The device of claim 162, wherein the analyte is glucose.

176. The device of claim 148, wherein the support structure comprises a self-contained vacuum chamber having a pressure less than atmospheric pressure.

150-158. -158. (canceled)

160. (canceled)

163. (canceled)

167-175. -175. (canceled)

177-258. -258. (canceled)

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

a support structure for application to the skin of the subject; and

a fluid transporter associated with the support structure,

wherein the device exhibits a success rate of at least about 95% of withdraw of at least 0.5 microliters of the fluid from the skin of the subject into the device, in a population of at least 100 randomly chosen subjects.

260. The device of claim 259, wherein the success rate is at least about 97%.

261. The device of claim 259, wherein the success rate is at least about 99%.

262. The device of claim 259, wherein the device exhibits a success rate of at least about 95% of withdraw of at least 1 microliter of the fluid.

263. The device of claim 259, wherein the device exhibits a success rate of at least about 95% of withdraw of at least 5 microliters of the fluid.