HUBBED DUAL CANNULA DEVICE FOR CLOSED CONTAINER SAMPLING SYSTEMS
The present invention provides a hubbed dual cannula device for extracting a fluid sample from a closed container. The device comprises a housing hub, two substantially parallel needles, a venting valve and a hydrophobic membrane, and may be used effectively to extract a fluid sample from a sealed container, such as a vacuum tube, without damaging the cellular components or activating platelets in the fluid sample. Also provided are methods for using the disclosed device to extract a fluid sample from a closed container and kits for measuring platelet aggregation using such a device.
1 . A device for extracting a fluid sample from a closed container, comprising:
(a) a housing hub comprising a first opening, a second opening, a venting port in fluid communication with the first opening, and an input port in fluid communication with the second opening,
(b) a venting tip having a sharp end and a blunt end, wherein the blunt end of the venting tip is engaged to the housing hub to establish fluid communication between the venting tip and the venting port;
(c) an input tip having a sharp end and a blunt end, wherein the blunt end of the input tip is engaged to the housing hub to establish fluid communication between the input tip and the input port;
(d) a venting valve positioned within the first opening, which valve permits a unidirectional air flow from outside the device to the closed container and prevents the fluid sample inside the closed container from leaking out of the first opening; and
(e) a hydrophobic membrane positioned adjacent to the venting valve, which membrane filters incoming air and prevents the fluid sample inside the closed container from leaking out of the first opening.
2 . The device of claim 1 , wherein the fluid sample is a whole blood sample.
3 . The device of claim 1 , wherein the fluid sample is a plasma sample.
4 . The device of claim 3 , wherein the plasma sample is a platelet rich plasma sample.
5 . The device of claim 1 , wherein the first opening is configured and adapted to accommodate the venting valve and the hydrophobic membrane.
6 . The device of claim 1 , wherein the second opening is configured and adapted to mate with a tapered luer lock tip.
7 . The device of claim 1 , wherein at least one of the venting and input tips comprises a syringe needle.
8 . The device of claim 7 , wherein the syringe needle is about 16 to 26 gauge.
9 . The device of claim 7 , wherein the syringe needle is a non-coring needle.
10 . The device of claim 7 , wherein the syringe needle comprises a chisel tip.
11 . The device of claim 1 , wherein the venting tip and the input tip have substantially equal lengths.
12 . The device of claim 1 , wherein the venting and input tips are substantially parallel to each other.
13 . The device of claim 12 , wherein the sharp ends of the venting and input tips are staggered in height or have substantially equal heights.
14 . The device of claim 1 , wherein the venting valve comprises a duckbill check valve.
15 . The device of claim 1 , wherein the hydrophobic membrane comprises a material that expands in the presence of a fluid.
16 . The device of claim 1 , wherein the housing hub comprises a thermoplastic material.
17 . The device of claim 1 , wherein the device is a single use device.
18 . A method for extracting a fluid sample from a closed container, comprising the steps of:
(a) providing the sample extracting device of claim 1 and a fluid sample in a closed container;
(b) piercing the closed container using the sharp ends of the venting and input tips to establish fluid communication between the closed container and the sample extracting device;
(c) altering the pressure within the device to extract the fluid sample.
19 . The method of claim 18 , wherein the fluid sample is a whole blood sample.
20 . The method of claim 18 , wherein the fluid sample is a plasma sample.
21 . The method of claim 20 , wherein the plasma sample is a platelet rich plasma sample.
22 . The method of claim 18 , wherein the closed container comprises a vacuum tube.
23 . The method of claim 22 , wherein the vacuum tube is selected from a full-draw vacuum tube and a partial-draw vacuum tube.
24 . A kit for measuring platelet aggregation in a fluid sample, the kit comprising the sample extracting device of claim 1 and a reagent for measuring platelet aggregation.
25 . The kit of claim 24 , further comprising a sample collection container.
26 . The kit of claim 25 , wherein the sample collection container is a vacuum tube.
27 . The kit of claim 26 , wherein the vacuum tube is selected from a full-draw vacuum tube and a partial-draw vacuum tube.
28 . The kit of claim 24 , wherein the reagent for measuring platelet aggregation comprises a GPIIb/IIIa receptor ligand immobilized on a particle.
29 . The kit of claim 28 , further comprising an anticoagulant and a buffer to maintain the pH and salt concentration of the fluid sample within a range suitable for platelet aggregation.
30 . The kit of claim 28 , wherein the GPIIb/IIIa receptor ligand comprises a substance selected from the group consisting of fibrinogen, monoclonal antibody 10E5, monoclonal antibody c7E3, von Willebrand factor, fibronectin, vitronectin, a ligand having an arginine glycine-aspartic acid (RGD) sequence and a peptide or a peptidomimetic mimicking RGD sequence.
31 . The kit of claim 28 , wherein the GPIIb/IIIa receptor ligand comprises fibrinogen.
32 . The kit of claim 24 , wherein the sample extracting device is a single use device.