Plasma or serum production and removal of fluids under reduced pressure

• US 10,188,335 B2
• Filed: 07/22/2015
• Issued: 01/29/2019
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Haghgooie, Ramin, Chickering, III, Donald E., Davis, Shawn, Michelman, Mark, Bernstein, Howard, Horton, Kristin
• Primary Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US14/805,678
• Publication Number:
  US 20150320349A1
• Time in Patent Office: 1,287 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150419 comprising means for capillary action
• 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 5/150984 : 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 5/15105 : Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3486 : Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
• CPC Class Codes: A61M 1/3687 : Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0415 : Plasma
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0874 : Three dimensional network
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0655 : pinch valves
• CPC Class Codes: B01L 2400/0688 : surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502753 : characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 33/18 : Water
• CPC Class Codes: G01N 33/1826 : organic contamination in water

Abstract

In some embodiments, the present invention generally relates to the separation of blood within a device to form plasma or serum. In some embodiments, the present invention generally relates to the removal of fluids, such as blood, contained within a device. In one aspect, the present invention is generally directed to systems and methods for receiving blood from a subject and processing the blood to form plasma or serum. For example, a device may be applied to the skin of a subject to receive blood from the subject and pass the blood through a separation membrane, which separates the blood into plasma and a portion concentrated in blood cells. As another example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device. The device may contain, in some cases, a vacuum source such as a pre-packaged vacuum to facilitate receiving of blood and/or passage of the blood through the separation membrane to produce plasma or serum. In certain embodiments, plasma, serum, or other fluids may be removed from the device by inserting a needle into a portion of the device that has reduced pressure, expelling gas into the device through the needle, then receiving plasma, serum, or other fluids through the needle.

Claims

1. A device for receiving blood from a subject and processing the blood to form plasma or serum, the device comprising:

an inlet for introduction of blood from the subject into the device;

a storage chamber for receiving plasma or serum;

a membrane that is substantially impermeable to cells, wherein the membrane separates the inlet from the storage chamber and is capable of separating blood passing through to produce a portion enriched in plasma or serum; and

a vacuum chamber, separate from the storage chamber, having a pressure less than ambient pressure;

wherein the device further comprises a first module and a second module removable from the first module, wherein the second module comprises the storage chamber.

2. The device of claim 1, wherein the storage chamber has a volume of less than about 10 ml.

3. The device of claim 1, wherein at least a portion of the storage chamber is coated with a material that promotes thrombolysis.

4. The device of claim 1, wherein at least a portion of the storage chamber is coated with a polyester.

5. The device of claim 1, wherein the device further contains an anticoagulant.

6. The device of claim 5, wherein the anticoagulant comprises heparin.

7. The device of claim 5, wherein the anticoagulant includes one or more of citrate, thrombin, oxalate, ethylenediaminetetraacetic acid (EDTA), sodium polyanethol sulfonate, or acid citrate dextrose.

8. The device of claim 1, wherein the membrane is a separation membrane.

9. The device of claim 1, wherein the membrane comprises a copolymer.

10. The device of claim 1, wherein the membrane has an average pore diameter of less than about 20 micrometers.

11. The device of claim 1, wherein the inlet is in fluid communication with the membrane by the fluid communication pathway.

12. The device of claim 1, wherein the inlet is in fluid communication with the membrane by a microfluidic channel.

13. The device of claim 1, wherein the vacuum chamber has a pressure, prior to introduction of a bodily fluid from the subject into the device, that is less than about 100 mmHg below ambient pressure.

14. The device of claim 1, further comprising a septum in fluid communication with the storage chamber.

15. The device of claim 14, wherein the septum comprises silicone.

16. The device of claim 1, wherein the device further comprises one or more microneedles positioned to be insertable into the skin of the subject to cause blood to flow to the inlet.

17. The device of claim 16, further comprising an activator that, when activated, fluidly communicates the pressure from the vacuum chamber to the one or more microneedles, wherein prior to activating the activator, the pressure from the vacuum chamber is not in fluid communication with the one or more microneedles.

18. The device of claim 1, further comprising a seal that can be manipulated to control a fluid communication pathway between the vacuum chamber and the storage chamber.

19. The device of claim 1, wherein the device further comprises a second membrane that is gas permeable but is substantially liquid impermeable, separating the storage chamber from the vacuum chamber.

20. The device of claim 1, wherein the device is self-contained.

21. A device for receiving blood from a subject and processing the blood to form plasma or serum, the device comprising:

an inlet for introduction of a bodily fluid from the subject into the device;

a storage chamber for receiving plasma or serum;

a first membrane that is substantially impermeable to cells, wherein the first membrane separates the inlet from the storage chamber and is capable of separating blood passing through to produce a portion enriched in plasma or serum;

a vacuum chamber, separate from the storage chamber, having a pressure less than ambient pressure; and

a second membrane that is gas permeable but is substantially liquid impermeable, wherein the second membrane separates the storage chamber from the vacuum chamber.

22. The device of claim 21, wherein the device further comprises a first module and a second module removable from the first module, wherein the second module comprises the storage chamber.

23. The device of claim 21, wherein the device further contains an anticoagulant.

24. The device of claim 21, wherein the vacuum chamber has a pressure, prior to introduction of a bodily fluid from the subject into the device, that is less than about 100 mmHg below ambient pressure.

25. The device of claim 21, wherein the storage chamber has a volume of less than about 10 ml.

26. The device of claim 21, wherein the device further comprises one or more microneedles positioned to be insertable into the skin of the subject to cause blood to flow to the inlet.

27. The device of claim 26, further comprising an activator that, when activated, fluidly communicates the pressure from the vacuum chamber to the one or more microneedles, wherein prior to activating the activator, the pressure from the vacuum chamber is not in fluid communication with the one or more microneedles.

28. The device of claim 21, further comprising a seal that can be manipulated to control a fluid communication pathway between the vacuum chamber and the storage chamber.