LOW-PRESSURE PACKAGING FOR FLUID DEVICES

• US 20130081960A1
• Filed: 11/15/2012
• Published: 04/04/2013
• Est. Priority Date: 07/16/2010
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Schott, Kevin
• Granted Patent: US 8,561,795 B2
• Time in Patent Office: Days
• US Class Current: 206/210
• 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

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. 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.

Claims

1. An article, comprising:

a receiving device for receiving blood and/or other bodily fluid from the skin and/or from beneath the skin of a subject, comprising at least one microneedle and a vacuum chamber containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure; and

a package containing therein the receiving device, the package comprising a material having a permeability to O₂ or N₂ of less than about 2000 cm³ mm/(m² Bar day), the package further containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure.

2. The article of claim 1, wherein one or more of the at least one microneedles is solid.

3. The article of claim 1, wherein at least a portion of the airtight package is manually deformable.

4. The article of claim 1, wherein at least a portion of the airtight package is rigid.

5. The article of claim 1, wherein the airtight package comprises a laminate of a metal and a polymer.

6. The article of claim 5, wherein the laminate comprises aluminum foil that is laminated to the polymer.

7. The article of claim 5, wherein the polymer is polyester.

8. The article of claim 1, wherein the vacuum chamber contains therein a reduced pressure that is less than about 500 mmHg below atmospheric pressure, and the package contains therein a reduced pressure that is less than about 500 mmHg below atmospheric pressure.

9. The article of claim 1, wherein the pressure of the vacuum chamber and the pressure of the airtight package are substantially equal.

10. The article of claim 1, wherein the receiving device defines therein a first volume, and the package defines therein a second volume defined externally of the receiving device, wherein the second volume is no more than about 25% of the first volume.

11. The article of claim 1, wherein the receiving device defines therein a first volume, and the package defines therein a second volume defined externally of the receiving device, wherein the second volume is at least about 50% of the first volume.

12. The article of claim 1, wherein the airtight package contains a sterile environment.

13. The article of claim 1, wherein the airtight package further comprises an oxygen scavenger.

14. The article of claim 13, wherein the oxygen scavenger is an oxygen scavenging film contained within the material of the package.

15. The article of claim 1, wherein the material of the package further comprises an oxygen barrier layer.

16. The article of claim 1, wherein the receiving device further comprises a device activator that, when the device activator is activated, applies the reduced pressure from the vacuum chamber to the skin of the subject to cause blood and/or other bodily fluids released from the subject due to action of the at least one microneedle to flow, from the subject, into the receiving device.

17. An article, comprising:

a receiving device for receiving blood and/or other bodily fluid from the skin and/or from beneath the skin of a subject, comprising at least one microneedle and a vacuum chamber containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure; and

a package containing therein the receiving device, the package comprising a metallized polymeric film, the package further containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure.

18. The article of claim 17, wherein the metallized polymer film comprises aluminum.

19. The article of claim 17, wherein the metallized polymer film comprises a polyester.

20. An article, comprising:

a receiving device for receiving blood and/or other bodily fluid from the skin and/or from beneath the skin of a subject, comprising at least one microneedle and a vacuum chamber containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure; and

a package containing therein the receiving device, the package containing therein a reduced pressure that is less than about 50 mmHg below atmospheric pressure, wherein the receiving device defines therein a first volume, and the package defines therein a second volume defined externally of the receiving device, wherein the second volume is no more than about 25% of the first volume.

21. The article of claim 20, wherein the airtight package is substantially molded onto the device therein due to the reduce pressure contained within the airtight package.

22. The article of claim 20, wherein the airtight package is manually deformable.

23. The article of claim 20, wherein the receiving device has a largest vertical dimension, when the receiving device is applied to receive blood and/or other bodily fluids, of no more than about 2 cm.

24. The article of claim 20, wherein the second volume is no more than about 10% of the first volume.

25. The article of claim 20, wherein the airtight package is substantially impermeable to microorganisms.

26. The article of claim 20, wherein the airtight package is able to withstand gamma radiation without substantial deformation.