Microscale plasma separator

• US 10,105,083 B1
• Filed: 06/26/2018
• Issued: 10/23/2018
• Est. Priority Date: 11/04/2014
• Status: Active Grant

• Current Assignee: Wainamics, Inc.
• Original Assignee: Wainamics, Inc.
• Inventors: Tan, Ming, Zaugg, Frank, Kernen, Peter
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US16/018,409
• Publication Number:
  US 20180303395A1
• Time in Patent Office: 119 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• 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: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/06 Ampoules or carpules syringe ampoules or carpules A61M5/28
• 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 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 3/0217 of the plunger pump type medical syringes A61M
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

The invention is directed to methods and devices for efficient separation of plasma from whole blood which are suitable for point of care use in resource poor environments. In some embodiments, elements of such devices comprise (a) a sample collection receptacle (SCR) with at least one port, the sample collection receptacle capable of holding a predetermined volume of a sample of undiluted whole blood drawn through a port; (b) a filter chamber having an inlet and an outlet, and containing at least one filter capable of separating plasma from blood cells as sample passes from an inlet side to an outlet side of the at least one filter whenever the filter chamber is placed in fluid communication with a port of the sample collection receptacle; and (c) a manually driven pump operationally associated with the SCR and filter chamber for (i) drawing a predetermined volume of sample into the SCR by a first user action and (ii) driving the predetermined volume at a substantially constant linear flow under a pressure not exceeding 2 psi from the SCR through the filter chamber and the outlet of the filter chamber by a second user action.

Claims

1. A method for separating plasma from whole blood, the device comprising:

(a) providing a sample collection receptacle with at least one port, the sample collection receptacle capable of holding a predetermined volume of a sample of whole blood drawn through a port;

(b) providing a detachable filter chamber having an inlet and an outlet, and containing at least one filter capable of separating plasma from blood cells as sample passes from an inlet side to an outlet side of the at least one filter whenever the inlet of the detachable filter chamber is placed in fluid communication with a port of the sample collection receptacle;

(c) manually driving a pump operationally associated with the sample collection receptacle to draw a predetermined volume of sample into the sample collection receptacle by a first user action;

(d) attaching the inlet of the detachable filter chamber to a port of the sample collection receptacle; and

(e) driving by a spring-drive mechanism or an elastomeric bladder the predetermined volume at a substantially constant linear flow under a pressure not exceeding 2 psi through the filter of the detachable filter chamber by a second user action, thereby expelling plasma from the outlet.

2. The method of claim 1 wherein said first user action includes expanding a spring operationally associated with said spring-drive mechanism.

3. The method of claim 2 wherein said spring-drive mechanism includes a mechanical catch to hold said spring in an expanded state.

4. The method of claim 3 wherein said second user action includes releasing said catch so that said expanded spring relaxes and drives a plunger operationally associated with said sample collection receptacle to drive plasma through said detachable filter chamber.

5. The method of claim 1 wherein said first user action includes compressing a spring operationally associated with said spring-drive mechanism.

6. The method of claim 5 wherein said spring-drive mechanism includes a releasable catch to hold said spring in compressed state.

7. The method of claim 6 wherein said second user action includes releasing said catch so that said compressed spring relaxes and drives a plunger operationally associated with said sample collection receptacle to drive plasma through said detachable filter chamber.

8. A device for separating plasma from whole blood, the device comprising:

(a) a sample collection receptacle with at least one port, the sample collection receptacle capable of holding a predetermined volume of a sample of whole blood drawn through a port;

(b) a disposable cap comprising a filter chamber having an inlet and an outlet, and containing at least one filter capable of separating plasma from blood cells as sample passes from an inlet side to an outlet side of the at least one filter whenever the filter chamber is sealingly connected to and in fluid communication with a port of the sample collection receptacle;

(c) a manually driven pump operationally associated with the sample collection receptacle for (i) drawing a predetermined volume of sample into the sample collection receptacle by a first user action, and (ii), after the disposable cap is attached to a port of the sample collection receptacle, driving by a spring-drive mechanism or an elastomeric bladder the predetermined volume at a substantially constant linear flow under a pressure not exceeding 2 psi through the filter chamber and the outlet of the disposable cap by a second user action.

9. The device of claim 8 wherein said sample collection receptacle comprises a body and a plunger moveably disposed within the body and forming fluid seals with walls of the body so that by moving the plunger in a first direction a negative pressure is exerted on said sample collection receptacle and by moving the plunger in a second direction a positive pressure is exerted on said sample collection receptacle, and wherein said spring-drive mechanism of said manually driven pump is operationally associated with the plunger and the body so that whenever the spring is in a relaxed state the plunger is disposed in the body to give said sample collection receptacle a first volume, said spring-drive mechanism comprising a releasable catch that permits the spring to be placed in a non-relaxed state by said first user action to give said sample collection reservoir a second volume, thereby causing the plunger to exert a negative pressure on said sample collection receptacle, and to be released from the non-relaxed state by said second user action, thereby returning the spring to a relaxed state and causing the plunger to exert a positive pressure on said sample collection receptacle.

10. The device of claim 9 wherein said first volume is substantially zero.

11. The device of claim 9 wherein said spring-drive mechanism comprises a compression spring.

12. The device of claim 9 wherein said manually driven pump further comprises a screw-drive mechanism operationally associated with said body and plunger wherein said first user action further displaces said plunger in said first direction by rotating the screw drive mechanism by a first rotation and said second user action further displaces said plunger in the second direction by rotating the screw drive mechanism by a second rotation.

13. The device of claim 8 wherein said sample collection receptacle comprises said elastomeric bladder, and wherein said elastomeric bladder of said manually driven pump comprises a mechanism for collapsing or releasing the elastomeric bladder such that by said first user action the mechanism releases the elastomeric bladder thereby changing a first volume of said sample collection receptacle to a second volume thereby drawing said sample into said sample collection receptacle, and such that by said second user action the mechanism collapses the elastomeric bladder thereby reducing the second volume and exerting a positive pressure on said sample.