RELATIVELY SMALL DEVICES APPLIED TO THE SKIN, MODULAR SYSTEMS, AND METHODS OF USE THEREOF

• US 20110105952A1
• 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: Walt, David R., Davis, Shawn, Levinson, Douglas A., Haghgooie, Ramin, Chickering, Donald E. III, Bernstein, Howard
• Application Number:
  US12/915,820
• Publication Number:
  US 20110105952A1
• Time in Patent Office: Days
• US Class Current: 600/573
• 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 5/150221 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 5/15109 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 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 relatively small devices applied to the skin, modular systems, and methods of use thereof. In some aspects, the device is constructed and arranged to have more than one module. For instance, the device may have a module for delivering to and/or withdrawing fluid from the skin and/or beneath the skin of a subject and a module for transmitting a signal indicative of the fluid delivered to and/or withdrawn from the skin and/or beneath the skin of the subject, a module for analyzing a fluid withdrawn from the skin and/or beneath the skin of the subject, or the like. In some embodiments, the modules are connectable and/or detachable from each other, and in some cases, the connections and/or detachments may be performed while the device is in contact with the subject, e.g., while affixed to the subject. In some embodiments, the device may be repeatedly applicable to the skin of the subject to deliver to and/or withdraw fluid from the skin and/or beneath the skin of a subject, e.g., at the same location, or at different locations on the skin of the subject. In some aspects, the devices may be self-contained and/or have a relatively small size, and in some cases, the device may be sized such that it is wearable and/or able to be carried by a subject. For example, the device may have a mass and/or dimensions that allow the device to be carried or worn by a subject for various periods of time, e.g., at least about an hour, at least about a day, at least about a week, etc., or no more than about an hour, no more than about 10 min, etc.

Claims

1. A device for analysis of an extractable 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

a signal structure for generating a signal indicative of the determination of at least one analyte contained within the fluid,

wherein the support structure and the signal structure are constructed and arranged to be readily connectable and/or detachable from each other.

2. The device of claim 1, wherein the support structure further comprises an adhesive for adhesion of the support structure to the skin.

6. The device of claim 1, wherein the fluid transporter is able to be activated using an actuator.

7. The device of claim 6, wherein the actuator comprises a button.

8. The device of claim 1, wherein the fluid transporter is able to be activated remotely.

9. The device of claim 1, wherein the device comprises a timing mechanism for timed activation of the fluid transporter after removal from packaging containing the device.

12. The device of claim 1, wherein the support structure further comprises a microfluidic channel in fluidic communication with the fluid transporter.

13. The device of claim 1, wherein the fluid comprises blood.

15. The device of claim 1, wherein the device further comprises a storage chamber in fluidic communication with the fluid transporter.

16. The device of claim 1, wherein the device is able to determine an analyte contained within the fluid withdrawn from the skin and/or from beneath the skin of the subject.

17. The device of claim 1, wherein the device is able to determine the analyte without subsequent removal of the device from the skin of the subject.

18. The device of claim 1, wherein the device is able to automatically determine the analyte.

19. The device of claim 1, wherein the device is able to display a result of the determination of the analyte.

20. The device of claim 1, wherein the fluid transporter comprises a needle.

21. The device of claim 20, wherein the needle is a microneedle.

24. The device of claim 1, wherein the fluid transporter is immobilized relative to the support structure.

25. The device of claim 1, wherein the device is able to withdraw the fluid transporter from the skin of the subject after exposure of the fluid transporter to the skin of the subject.

27. The device of claim 1, wherein the support structure is able to apply a pressure less than atmospheric pressure to the skin of the subject.

28. The device of claim 1, wherein the support structure comprises a self-contained vacuum chamber having a pressure less than atmospheric pressure.

29. The device of claim 1, wherein the fluid transporter is able to move relative to the support structure.

30. The device of claim 1, wherein the fluid transporter is able to be activated by the subject.

31. The device of claim 1, wherein the fluid transporter is able to be activated upon applying the device to the skin of the subject.

32. The device of claim 1, wherein the device further comprises a heater for applying heat to the skin of the subject.

34. The device of claim 1, wherein the at least one analyte comprises glucose.

3-5. -5. (canceled)

10-11. -11. (canceled)

14. (canceled)

22-23. -23. (canceled)

26. (canceled)

33. (canceled)

35-49. -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 support structure for application to the skin of the subject;

a fluid transporter associated with the support structure; and

a stabilizing agent for stabilizing the fluid withdrawn from the skin in fluid communication with the fluid transporter.

51-101. -101. (canceled)

102. A device for extraction of 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;

a sensor for determining at least one condition of a fluid extracted from the skin and/or from beneath the skin of the subject; and

a signal and/or display generator for generating a signal and/or display relating to the at least one condition of the fluid determined by the sensor,

wherein the device comprises at least one of;

a largest lateral dimension, when the device is positioned for extraction of the fluid, parallel to the extraction area, of no more than about 7 cm,

a largest vertical dimension, extending from the skin of the subject when the device is positioned for extraction of the fluid, of no more than about 3 cm, or

a mass of no more than about 150 g, absent the fluid.

103. The device of claim 102, wherein the support structure further comprises an adhesive for adhesion of the support structure to the skin.

104. The device of claim 102, wherein the largest lateral dimension is between about 2 cm and about 7 cm.

105. The device of claim 102, wherein the largest vertical dimension is between about 2 and about 3 cm.

106. The device of claim 102, wherein the mass is between about 30 g and about 150 g.

107. The device of claim 102, wherein the sensor is a glucose sensor.

108. The device of claim 102, wherein the sensor is a test strip.

109-125. -125. (canceled)

126. A self-contained device for delivering to and/or 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 for delivery to and/or withdrawal of the fluid from the skin and/or beneath the skin of the subject,

wherein the device is constructed and arranged to be wearable by the subject for at least about 15 minutes.

127-134. -134. (canceled)

135. 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 support structure for application to the skin of the subject;

a fluid transporter associated with the support structure; and

a sensor for determining a condition of the fluid delivered to and/or withdrawn from the skin and/or beneath the skin of the subject,

wherein the device is constructed and arranged to be wearable by the subject for at least about 15 minutes.

136. The device of claim 135, wherein the sensor is a glucose sensor.

137. The device of claim 135, wherein the sensor is a test strip.

138-177. -177. (canceled)

178. 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 support structure for application to the skin of the subject;

a fluid transporter associated with the support structure; and

a removable module constructed and arranged to be reversibly removable from the support structure, wherein the removable module comprises one or more of a pressure controller, an actuator for the fluid transporter, a sensor, a fluid assay, a collection chamber, a processor, a memory component, a transmitter, or a display.