LOW-PRESSURE PACKAGING FOR FLUID DEVICES

• US 20120016308A1
• Filed: 07/15/2011
• Published: 01/19/2012
• Est. Priority Date: 07/16/2010
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Schott, Kevin
• Application Number:
  US13/183,789
• Publication Number:
  US 20120016308A1
• Time in Patent Office: Days
• US Class Current: 604/173
• 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 5/150175 Adjustment of penetration depth
• 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 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• 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 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: B65D 81/20 under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas B65D81/28 takes precedence; containers with pressurising means for maintaining ball pressure A63B39/025

Abstract

The present invention generally relates to systems and methods for delivering and/or withdrawing fluid from subjects, e.g., through the skin, including packaging associated with such systems. Certain aspects of the invention are generally directed to devices for withdrawing a substance from the skin and/or from beneath the skin of a subject, and/or for delivering a substance to the skin and/or to a location beneath the skin of a subject. In some embodiments, the devices may comprise one or more skin insertion objects, such as needles or microneedles. In some cases, the device also may comprise one or more vacuum chambers, e.g., having an internal pressure less than atmospheric pressure. In some aspects, the device may be contained within an environment able to assist with maintenance of such pressures. For example, a package containing such an environment may also have a pressure less than atmospheric pressure, and/or the package may be molded to the device or otherwise have a shape that does not contain substantial gases that can “leak” into the device and alter the pressure of any vacuum chambers that may be contained therein. In some embodiments, the pressure of the environment may be the same as or less than that of vacuum chambers contained within the device. Other aspects of the invention are generally directed to methods of creating such devices, techniques for using such devices, kits involving such devices, and the like.

Claims

1. An article, comprising:

an environment having a pressure that is less than about 50 mmHg below atmospheric pressure, the environment surrounding a device comprising a substance transfer component for receiving a substance from the skin and/or from beneath the skin of a subject, and/or for delivering a substance to the skin and/or to a location beneath the skin of a subject.

2. The article of claim 1, wherein the environment is contained within an external package.

3. The article of claim 2, wherein at least a portion of the external package is manually deformable.

4. The article of claim 2, wherein at least a portion of the external package is rigid.

5. The article of claim 1, wherein the device further comprises an activator for inserting the skin insertion objects into the skin of the subject.

6. The article of claim 5, wherein the external package comprises a rigid material surrounding at least the activator.

7. The article of claim 2, wherein the external package substantially molds the device therein.

8. The article of claim 2, wherein the external package comprises glass.

9. The article of claim 2, wherein the external package comprises polyethylene.

10. The article of claim 2, wherein the external package comprises polycarbonate.

11. The article of claim 2, wherein the external package comprises a metal.

12. The article of claim 2, wherein the external package comprises aluminum.

13. The article of claim 2, wherein the external package comprises a laminate.

14. The article of claim 2, wherein the external package comprises Mylar.

15. The article of claim 1, wherein the pressure is less than about 100 mmHg below atmospheric pressure.

21. The article of claim 1, wherein the environment is substantially sterile.

22. The article of claim 1, wherein the device comprises a vacuum chamber having an internal pressure less than atmospheric pressure.

23. The article of claim 22, wherein the internal pressure is less than about 50 mmHg below atmospheric pressure.

24. The article of claim 22, wherein the internal pressure is less than about 100 mmHg below atmospheric pressure.

29. The article of claim 22, wherein the internal pressure of the vacuum chamber within the device is substantially equal to the pressure of the environment surrounding the device.

30. The article of claim 1, wherein the substance transfer component includes one or more skin insertion objects.

31. The article of claim 30, wherein the one or more skin insertion objects comprises one or more microneedles.

32. The article of claim 31, wherein at least some of the microneedles are solid.

33. The article of claim 31, wherein at least some of the microneedles are hollow.

16-20. -20. (canceled)

25-28. -28. (canceled)

34. A method, comprising:

exposing a device to an environment having a pressure that is less than about 50 mmHg below atmospheric pressure, wherein the device comprises a substance transfer component for receiving a substance from the skin and/or from beneath the skin of a subject, and/or for delivering a substance to the skin and/or to a location beneath the skin of a subject.

35. An article, comprising:

an environment having a pressure that is less than about 50 mmHg below atmospheric pressure, the environment surrounding a device comprising a needle and a vacuum chamber having an internal pressure less than atmospheric pressure.