Plasma or serum production and removal of fluids under reduced pressure
View Patent ↗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. 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example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device.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.
1. A device for receiving bodily fluid from a subject and processing the bodily fluid to form plasma or serum, the device comprising:
an opening for introduction of a bodily fluid from the subject into the device;
a separation membrane in fluid communication with the opening on a first side of the membrane, the separation membrane sized such that the bodily fluid passing therethrough is separated to form plasma or serum;
a vacuum chamber having a pressure less than ambient pressure before the device is applied to the skin of the subject;
a seal that can be manipulated to control a fluid communication pathway between the vacuum chamber and a second side of the separation membrane; and
a flow activator comprising one or more microneedles positioned to cause release of bodily fluid from the subject.
2. The device of claim 1 , wherein the separation membrane comprises a polysulfone.
3. The device of claim 1 , wherein the separation membrane comprises a polyethersulfone.
4. The device of claim 1 , wherein the separation membrane comprises a nitrocellulose.
5. The device of claim 1 , wherein the separation membrane has an average pore diameter of less than about 20 micrometers.
6. The device of claim 1 , wherein the separation membrane has an average pore diameter of less than about 8 micrometers.
7. The device of claim 1 , wherein the separation membrane has an average pore diameter of less than about 4 micrometers.
8. The device of claim 1 , wherein the opening is positioned within an applicator region positioned to collect bodily fluid from the skin of the subject.
9. 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 lower than about 100 mmHg below ambient pressure.
10. The device of claim 1 , further comprising a storage chamber in fluid communication with the second side of the separation membrane.
11. The device of claim 10 , wherein the storage chamber contains an anticoagulant.
12. The device of claim 1 , wherein the separation membrane has an area less than 5 square centimeters.
13. The device of claim 1 , wherein the separation membrane has an area less than 1 square centimeter.
14. The device of claim 1 , wherein the separation membrane has an area less than 0.5 square centimeters.
15. The device of claim 1 , wherein the separation membrane contains an anticoagulant.
16. The device of claim 1 , wherein the fluid communication pathway contains an anticoagulant.