Managing blood samples using open-cell foam

Abstract

Disclosed is a sample mixing and transfer device adapted to receive a sample. [Solution] The device provided by the present invention includes a housing having a first end, a second end and a sidewall extending therebetween, a dry anticoagulant powder disposed within the housing, and a mixing element disposed within the housing.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 063,536, filed October 14, 2014, entitled "Blood Sample Management Using Open Cell Foam," and U.S. Provisional Patent Application No. 62 / 207,618, filed August 20, 2015, entitled "Blood Sample Management Using Open Cell Foam," the entire disclosures of each of which are incorporated herein by reference.

[0002] Field of Disclosure The present disclosure relates generally to blood transfer devices. More particularly, the present disclosure relates to blood transfer devices, blood transfer and testing systems, lancets and blood transfer devices, and methods for adding anticoagulants. [Background technology]

[0003] Blood sampling is a common medical procedure that involves the withdrawal of at least one drop of blood from a patient. Blood samples are typically taken from hospitalized, home health, and emergency room patients by either finger stick, heel stick, or venipuncture. Once collected, the blood sample can be analyzed to obtain medically useful information, including, for example, chemical composition, hematology, and coagulation information.

[0004] Blood tests determine a patient's physiological and biochemical status, including disease, mineral content, drug effectiveness, and organ function. Blood tests can be performed in a clinical laboratory or at the point of care near the patient. Summary of the Invention

[0005] The present disclosure provides a sample mixing and transfer device adapted to receive a sample. The sample mixing and transfer device includes a housing, a pore-containing material disposed within the housing, and a dry anticoagulant powder within the pores of the material. In one embodiment, the material is a sponge material. In another embodiment, the material is an open-cell foam. In one embodiment, the open-cell foam is treated with an anticoagulant to form a dry anticoagulant powder finely distributed throughout the pores of the material. A blood sample may be received within the sample mixing and transfer device. The blood sample is exposed to and mixed with the anticoagulant powder while passing through the material.

[0006] The disclosed sample mixing and transfer device provides uniform, passive mixing with blood anticoagulants under flow-through conditions. The disclosed sample mixing and transfer device can capture blood clots or other contaminants in the microstructure of the material and prevent them from dispensing into the diagnostic sample port. The disclosed sample mixing and transfer device allows for a simple, low-cost design for passive flow-through blood stabilization. The disclosed sample mixing and transfer device allows for precisely controlled addition of anticoagulant into the material by immersing it in a solution of anticoagulant and water and then drying the material to form a finely dispersed, dry anticoagulant powder throughout the pores of the material.

[0007] The disclosed sample mixing and transfer devices can provide an effective passive blood mixing solution for applications where blood flows through a line. Such sample mixing and transfer devices are useful for small blood volumes, e.g., less than 50 μL or less than 500 μL, and / or where inertial forces, e.g., gravity-based inertial forces, are ineffective for bulk manual mixing, such as required for evacuated tubes, by inverting the blood collection container back and forth.

[0008] According to one embodiment of the present invention, a specimen mixing and transfer device adapted to receive a sample comprises a housing having a first end, a second end and a sidewall extending therebetween, a material including pores disposed within the housing, and a dry anticoagulant powder within the pores of the material.

[0009] In one configuration, the sample is a blood sample. The housing is adapted to receive the blood sample therein via the first end. In yet another configuration, once the blood sample is received in the housing, it passes through the material, thereby effectively mixing the blood sample with the dry anticoagulant powder. In one configuration, the blood sample dissolves and mixes with the dry anticoagulant powder as it passes through the material. In another configuration, the material is an open-cell foam. In yet another configuration, the material is a sponge. In one configuration, the first end includes an inlet. In another configuration, the second end includes an outlet. In yet another configuration, the housing defines a mixing chamber having a material including pores disposed within the mixing chamber. In one configuration, the housing includes an inlet channel in fluid communication with the inlet and the mixing chamber, and an outlet channel in fluid communication with the mixing chamber and the outlet. In yet another configuration, the housing includes a distribution chamber between the mixing chamber and the outlet.

[0010] According to another embodiment of the present invention, a specimen mixing and transfer device adapted to receive a sample includes a housing having a first end, a second end and a sidewall extending therebetween, a dry anticoagulant powder disposed within the housing, and a mixing element disposed within the housing.

[0011] In one configuration, the specimen is the blood sample. In another configuration, the housing is adapted to receive the blood sample therein via the first end. In yet another configuration, with the blood sample received in the housing, the mixing element disrupts the flow of the blood sample to facilitate mixing of the blood sample with the dry anticoagulant powder. In one configuration, the dry anticoagulant powder is deposited on an interior surface of the housing. In another configuration, the mixing element includes a plurality of posts. In one configuration, the first end includes an inlet. In another configuration, the second end includes an outlet. In yet another configuration, the housing defines a mixing chamber having dry anticoagulant powder disposed therein. In one configuration, the housing includes an inlet channel in fluid communication with the inlet and the mixing chamber, and an outlet channel in fluid communication with the mixing chamber and the outlet. In another configuration, the housing includes a distribution chamber between the mixing chamber and the outlet. In yet another configuration, the housing includes two bypass flow paths between the inlet and outlet flow paths.

[0012] In accordance with yet another aspect of the present invention, a method of adding an anticoagulant to a material having pores includes immersing the material in a liquid solution of the anticoagulant and water, allowing the water from the liquid solution to evaporate, and forming a dry anticoagulant powder within the pores of the material.

[0013] In one configuration, the material is a sponge. In another configuration, the material is an open cell foam.

[0014] The foregoing and other features and advantages of the present disclosure, and the manner in which they are accomplished, will become more apparent, and the disclosure itself will be understood by reference to the following description of embodiments of the disclosure, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a partial cross-sectional view of a sample mixing and transfer device according to one embodiment of the present invention. [Figure 2]1 is a photomicrograph of the microstructure of an open-cell foam material having dry anticoagulant powder distributed throughout its microstructure, according to one embodiment of the present invention. [Figure 3] 10 is a partial cross-sectional view of a sample mixing and transfer device according to another embodiment of the present invention. [Figure 4] 1 is a perspective view of a sample mixing and transfer device according to one embodiment of the present invention; [Figure 5] 1 is a partial cross-sectional view of a sample mixing and transfer device according to one embodiment of the present invention. [Figure 6] FIG. 6 is a partial cross-sectional view taken along line 6-6 of FIG. 5, according to one embodiment of the present invention. [Figure 7] FIG. 10 is a perspective view of a sample mixing and transfer device according to another embodiment of the present invention. [Figure 8] 10 is a partial cross-sectional view of a sample mixing and transfer device according to another embodiment of the present invention. [Figure 9] 9 is a partial cross-sectional view taken along line 9-9 of FIG. 8, according to one embodiment of the present invention. [Figure 10] 10 is a perspective view of an alternative embodiment of a sample mixing and transfer device according to another embodiment of the present invention. [Figure 11A] FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the present invention. [Figure 11B] 2 is a partial enlarged perspective view of the syringe assembly of FIG. 1 in accordance with one embodiment of the present invention. [Figure 11C] FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the present invention. [Figure 12] 1 is a perspective view of an open cell foam material according to one embodiment of the present invention. FIG. [Figure 13] 1 is a photomicrograph of the microstructure of an open-cell foam material having dry anticoagulant powder distributed throughout its microstructure, according to one embodiment of the present invention. [Figure 14] 1 is a photomicrograph of the microstructure of untreated foam material. [Figure 15] FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the present invention. [Figure 16] 1 is a graph illustrating anticoagulant uptake by a blood sample flowing through an open-cell foam material having dry anticoagulant powder distributed throughout its microstructure, according to one embodiment of the present invention. [Figure 17] 1 is a perspective view of a blood transfer system according to one embodiment of the present invention. FIG. [Figure 18] 1 is a perspective view of a blood transfer system according to one embodiment of the present invention. FIG. [Figure 19] 1 is a perspective view of a blood transfer system according to one embodiment of the present invention. FIG. [Figure 20] 1 is a perspective view of a blood transfer system according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0016] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present disclosure in any way.

[0017] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives will, however, be readily apparent to those skilled in the art. It is intended that any and all such modifications, variations, equivalents, and alternatives be included within the spirit and scope of the present invention.

[0018] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention can assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in and described in the accompanying drawings in the following specification are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0019] 1-3 illustrate exemplary embodiments of the sample mixing and transfer device of the present disclosure. The sample mixing and transfer device 10 is adapted to receive a sample 12. In one embodiment, the sample mixing and transfer device 10 includes a housing 14, a pore 18 disposed within the housing 14, and a dry anticoagulant powder 20 within the pore 18 of the material 16.

[0020] With the sample 12 received within the sample mixing and transfer device 10, portions of the sample mixing and transfer device 10 act as a flow-through chamber for effective mixing of the sample 12 with the dry anticoagulant powder 20 within the substance 16. In other embodiments, the substance 16 may include other dry substances. Effective mixing occurs when the sample 12 passes through the substance 16 having the dry anticoagulant powder 20 distributed throughout its microstructure. This is achieved by:

[0021] The sample mixing and transfer device 10 of the present disclosure provides uniform, passive mixing of blood with anticoagulant under flow-through conditions. The sample mixing and transfer device 10 of the present disclosure captures blood clots or other contaminants within the microstructure of the material 16 and prevents them from dispensing to the diagnostic sample port. The sample mixing and transfer device 10 of the present disclosure enables a simple, low-cost design for passive flow-through blood stabilization. The sample mixing and transfer device 10 of the present disclosure enables precisely controlled addition of anticoagulant into the material 16 by immersing it in a solution of anticoagulant and water and then drying the material 16 to form a finely distributed dry anticoagulant powder 20 throughout the pores 18 of the material 16.

[0022] The sample mixing and transfer device 10 of the present invention can provide an effective, passive blood mixing solution for applications where blood flows through a line. Such a sample mixing and transfer device 10 is useful for small blood volumes, e.g., less than 50 μL or less than 500 μL, and / or where inertial forces, e.g., gravity-based inertial forces, are ineffective for bulk manual mixing, such as required for evacuated tubes, by inverting the blood collection container back and forth.

[0023] FIG. 1 illustrates an exemplary embodiment of a sample mixing and transfer device 10 of the present disclosure. Referring to FIG. 1 , in one embodiment, the sample mixing and transfer device 10 includes a housing 14, a material 16 including pores 18 disposed within the housing 14, and a dry anticoagulant powder 20 within the pores 18 of the material 16. The housing 14 includes a first end 22, a second end 24, and a sidewall 26 extending between the first end 22 and the second end 24. In one embodiment, the first end 22 includes an inlet 28, and the second end 24 includes an outlet 30.

[0024] 1 , in one embodiment, the housing 14 of the sample mixing and transfer device 10 includes an inlet channel 32 and an outlet channel 34. The inlet channel 32 and the outlet channel 34 are in fluid communication via a flow channel or mixing chamber 36. For example, the inlet channel 32 is in fluid communication with the inlet 28 and the mixing chamber 36, and the outlet channel 34 is in fluid communication with the mixing chamber 36 and the outlet 30. In one embodiment, the substance 16 is disposed within the mixing chamber 36 of the housing 14.

[0025] In one embodiment, the material 16 is a sponge material. In another embodiment, the material 16 is an open-cell foam. In one embodiment, the open-cell foam is treated with an anticoagulant to form a dry anticoagulant powder 20 finely distributed throughout the pores 18 of the material 16, as described in detail below. The sample 12 may be received within the sample mixing and transfer device 10. In some embodiments, the sample 12 is immersed in the material 16 by capillary action. In some embodiments, the sample 12 may be a blood sample. The blood sample is exposed to and mixed with the anticoagulant powder 20 as it passes through the intricate microstructure of the material 16. In this manner, the sample mixing and transfer device 10 produces a stabilized sample. In some embodiments, the stabilized sample may be transferred to a diagnostic instrument, such as a blood testing instrument, a point-of-care testing instrument, or similar analytical instrument.

[0026] In one embodiment, the substance 16 is an open-cell foam. For example, the substance 16 is a soft, deformable, blood-inert open-cell foam. In one embodiment, the open-cell foam can be a melamine foam, such as Basotect®, available from BASF®. In another embodiment, the open-cell foam can be comprised of a formaldehyde-melamine-sodium bisulfite copolymer. The open-cell foam can also be a flexible, hydrophilic open-cell foam that is resistant to heat and many organic solvents. In one embodiment, the open-cell foam can be a sponge material.

[0027] A method of adding an anticoagulant to a material 16 having pores 18 is now described. In one embodiment, the method includes immersing the material 16 in a liquid solution of anticoagulant and water, allowing the water from the liquid solution to evaporate, and forming a dry anticoagulant powder 20 within the pores 18 of the material 16.

[0028] The disclosed method allows for precisely controlled application of anticoagulant into material 16 by immersing it in a solution of anticoagulant and water and then drying material 16 to form a finely distributed dry anticoagulant powder 20 throughout the pores 18 of material 16, as shown in FIG. 2.

[0029] Anticoagulants such as heparin or EDTA (ethylenediaminetetraacetic acid) as well as other blood stabilizers can be introduced into material 16 as a liquid solution by immersing material 16 in a solution of the desired concentration. After evaporation of the liquid phase, for example, after evaporating water from a solution of water and heparin, dry anticoagulant powder 20 is formed and finely distributed throughout the internal structure of material 16, as shown in FIG. 2. For example, dry anticoagulant powder 20 is formed and finely distributed throughout pores 18 of material 16. Material 16 can be treated to provide hydrophobic, hydrophilic, or reactive internal pore surfaces as well.

[0030] In one configuration, a key advantage of providing open-cell foam as material 16 is the ability to add a known amount of anticoagulant into the pores 18 of the foam. A desired concentration of anticoagulant can be dissolved in water or another suitable solvent and then introduced into the pores 18 of the liquid open-cell foam 16. In one embodiment, the anticoagulant can be added into the pores 18 by immersing the open-cell foam 16 in a solution of anticoagulant and water or a solvent, and then drying the open-cell foam 16. The open-cell foam 16 may be dried in air or in a heated oven. After drying, the anticoagulant can be distributed in dry powder form throughout the internal microstructure of the open-cell foam 16.

[0031] It should be noted that, as discussed above, a suitable hydrophilic foam having interconnected cell pores may be loaded with an anticoagulant and used as described herein for flow-through blood stabilization.

[0032] One important advantage of using melamine-based open-cell foam materials is that melamine foams generally have low analyte bias. As described herein, analyte bias is the difference in an analyte measurement compared to a blood control value. Analyte bias typically occurs when the analyte adheres to the surface of a material, when the analyte is leached from the material by the introduction of other elements that may interfere with the measurement, or upon activation of a biological process. Additional open-cell foam materials suitable for use as described herein include organic thermoplastic and thermoset polymers and copolymers, including, but not limited to, polyolefins such as polyethylene terephthalate (PET), polypropylene (PP), polyethylene (PE), polyimides, and polyamides. The materials may be woven or randomly fibrous, or may have a fibrous structure, such as an irregular 3D structure.

[0033] To avoid or minimize potential analyte bias associated with the housing 14 of the transfer device 10, the material of the housing 14 may be treated. In one embodiment, the housing 14 may be treated with an additive coating that acts to prevent analytes from adhering to the surface. The additive coating may include, but is not limited to: 1) proteins such as bovine serum albumin (BSA), casein, or nonfat milk; 2) surfactants such as polysorbate 20 (Tween® 20) and organosilicone (L-720); 3) polymers and copolymers such as polyethylene glycol (PEG), polyvinyl alcohol (PVA), and polyvinylpyrrolidone (PVP); 4) carbohydrates such as destran and glycosaminoglycans, such as heparin; and 5) cell membrane-mimetic polymers such as LIPIDURE®.

[0034] Alternatively, the housing 14 can be treated with a chemical surface modification, which can include, but is not limited to, 1) gas plasma treatment, 2) chemical bonding or polyethylene glycol (PEG) or other polymers to achieve a desired hydrophobicity or hydrophilicity, 3) hydrophilic compositions such as ethylene glycol, or surface chemical modification containing hydrophobic groups such as long carbon chains, and 4) vapor deposition of materials such as parylene. It is understood herein that any combination of the above materials can be used to achieve desired properties to minimize analyte bias for a particular analyte or group of analytes.

[0035] In one embodiment, the mixing chamber 36 contains a substance 16 having therein a dry anticoagulant powder 20. For example, with reference to Figures 1 and 3, the substance 16 is disposed within the mixing chamber 36 of the sample mixing and transfer device 10. The anticoagulant can be added to the substance 16 having pores 18 as described above.

[0036] 1 , the housing 14 of the sample mixing and transfer device 10 is adapted to receive the sample 12 therein via a first end 22. For example, the housing 14 of the sample mixing and transfer device 10 is adapted to receive the sample 12 therein via an inlet 28. After the sample 12 enters the sample mixing and transfer device 10 via the inlet 28, the sample 12 flows through an inlet channel 32 into a mixing chamber 36.

[0037] With the sample 12 received within the mixing chamber 36, the mixing chamber 36 acts as a flow-through chamber for effective mixing of the sample 12 with the dry anticoagulant powder 20 within the substance 16. In other embodiments, the substance 16 may include other dry substances. Effective mixing is achieved by passing the sample 12 through the substance 16 having the dry anticoagulant powder 20 distributed throughout its microstructure. As the sample 12 passes through the substance 16, it dissolves and mixes with the dry anticoagulant powder 20.

[0038] Referring to FIG. 2, there is shown a diagram of the microstructure of material 16 having dry anticoagulant powder 20 distributed throughout its microstructure, eg, pores 18 thereof.

[0039] 3, in one embodiment, the housing 14 of the sample mixing and transfer device 10 includes a dispensing or storage chamber 38. The dispensing chamber 38 may be adjacent to the outlet 30 of the sample mixing and transfer device 10. For example, the dispensing chamber 38 may be located between the mixing chamber 36 and the outlet 30.

[0040] After the blood sample is exposed to and mixed with anticoagulant powder 20 while passing through the intricate microstructure of material 16, the stabilized sample flows from material 16 to distribution chamber 38 via outlet channel 34. The stabilized sample can remain in distribution chamber 38 for as long as desired to transfer the stabilized sample from sample mixing and transfer device 10. For example, the stabilized sample can be transferred to a diagnostic instrument such as a hematology tester, point-of-care testing instrument, or similar analytical instrument.

[0041] 4-10 illustrate other exemplary embodiments of the disclosed sample mixing and transfer device. Referring to Figures 4-10, the disclosed sample mixing and transfer device can be effective for small blood volumes typically associated with laminar flow conditions, requiring flow obstacles to facilitate mixing with the dried anticoagulant deposited on the walls of the flow-through structure.

[0042] 4-6 illustrate another exemplary embodiment of a sample mixing and transfer device of the present disclosure. The sample mixing and transfer device 100 is adapted to receive a sample 112. In some embodiments, the sample 112 may be a blood sample. In one embodiment, the sample mixing and transfer device 100 includes a housing 114, a dry anticoagulant powder 120 disposed within the housing 114, and a mixing element 115 disposed within the housing 114.

[0043] The housing 114 includes a first end 122, a second end 124, and a sidewall 126 extending between the first end 122 and the second end 124. In one embodiment, the first end 122 includes an inlet 128 and the second end 124 includes an outlet 130.

[0044] 5, in one embodiment, the housing 114 of the sample mixing and transfer device 100 includes an inlet channel 132 and an outlet channel 134. The inlet channel 132 and the outlet channel 134 are in fluid communication via a channel or mixing chamber 136. For example, the inlet channel 132 is in fluid communication with the inlet 128 and the mixing chamber 136. The outlet channel 134 is in fluid communication with the mixing chamber 136 and the outlet 130. In one embodiment, the dry anticoagulant powder 120 is disposed within the mixing chamber 136 of the housing 114.

[0045] In one embodiment, the inlet channel 132 and the outlet channel 134 are in fluid communication via a first channel 140 and a second channel 142. For example, the inlet channel 132 can branch into two separate channels, e.g., the first channel 140 and the second channel 142. As shown in FIG. 5 , the two separate channels, e.g., the first channel 140 and the second channel 142, can both flow into the outlet channel 134.

[0046] First flow channel 140 includes a wall 144, and second flow channel 142 includes a wall 146. In one embodiment, a first portion of dry anticoagulant powder 120 is deposited on wall 144, and a second portion of dry anticoagulant powder 120 is deposited on wall 146. For example, in one embodiment, a first portion of dry anticoagulant powder 120 is deposited on an inner surface of housing 114, e.g., on inner surface 148 of wall 144, and a second portion of dry anticoagulant powder 120 is deposited on an inner surface of housing 114, e.g., on inner surface 148 of wall 146.

[0047] 5, in one embodiment, the housing 114 of the sample mixing and transfer device 100 includes a distribution or storage chamber 138. The distribution chamber 138 may be adjacent to the outlet 130 of the sample mixing and transfer device 100. For example, the distribution chamber 138 may be located between the mixing chamber 136 and the outlet 130. In one embodiment, the distribution chamber 138 may be positioned between the flow channels 140, 142 and the outlet 130.

[0048] In one embodiment, the sample mixing and transfer device 100 includes a mixing element 115 disposed within the housing 114. For example, a portion of the mixing chamber 136 can also include an obstacle or mixing facilitator 150 that obstructs the flow path of the blood sample, thereby facilitating mixing between the blood sample and the dry anticoagulant powder 120. In some embodiments, a portion of the first flow path 140 and a portion of the second flow path 142 can include an obstacle or mixing facilitator 150 that obstructs the flow path of the blood sample, thereby facilitating mixing between the blood sample 120 and the dry anticoagulant powder.

[0049] 4-6, sample mixing and transfer device 100 is adapted to receive sample 112 therein via first end 122. For example, housing 114 of sample mixing and transfer device 100 is adapted to receive sample 112 therein via inlet 128. Sample 112 flows into inlet 128 and into inlet channel 132. In some embodiments, sample 112 may be a blood sample.

[0050] With a blood sample received in the inlet channel 140, a first portion 152 of the blood sample flows into the first channel 140 and a second portion 154 of the blood sample flows into the second channel 142. The first channel 140 provides a first flow path for the first portion 152 of the blood sample, and the second channel 142 provides a second flow path for the second portion 154 of the blood sample.

[0051] With first portion 152 of the blood sample received within first flow channel 140, first portion 152 of the blood sample mixes with a first portion of the dry anticoagulant powder 120 deposited on walls 144 of first flow channel 142. First flow channel 142 may also include an obstacle or mixing facilitator 150 that obstructs the flow path of the blood sample, thereby facilitating mixing between the blood sample and first portion of the dry anticoagulant powder 120. After mixing, first portion 154 of the blood sample and the first portion of the dry anticoagulant powder 120, i.e., the stabilized blood sample, move to outlet flow channel 134.

[0052] With the second portion 154 of the blood sample received in the second flow channel 142, the second portion 154 of the blood sample mixes with the second portion of the dry anticoagulant powder 120 deposited on the wall 146 of the second flow channel 140. The second flow channel 140 may also include an obstacle or mixing facilitator 150 that obstructs the flow path of the blood sample, thereby facilitating mixing between the blood sample and the second portion of the dry anticoagulant powder 120. After mixing, the second portion 152 of the blood sample and the second portion of the dry anticoagulant powder 120, i.e., the stabilized blood sample, move to the outlet flow channel 134.

[0053] In other embodiments, other portions of the sample mixing and transport device 100 may include an obstacle or mixer 150 that obstructs the flow path of the blood sample, thereby promoting mixing between the blood sample and the dry anticoagulant powder 120.

[0054] 7-10 illustrate other exemplary embodiments of the sample mixing and transfer device of the present disclosure. Referring to FIGS. 7 and 8, sample mixing and transfer device 200 is adapted to receive sample 212. In some embodiments, sample 212 may be a blood sample. In one embodiment, sample mixing and transfer device 200 includes housing 214, dry anticoagulant powder 220 disposed within housing 214, and mixing element 215 disposed within housing 214.

[0055] Housing 214 includes a first end 222, a second end 224, and a sidewall 226 extending between first end 222 and second end 224. In one embodiment, first end 222 includes an inlet 228 and second end 224 includes an outlet 230.

[0056] 8 , in one embodiment, the housing 214 of the sample mixing and transfer device 200 includes an inlet channel 232 and an outlet channel 234. The inlet channel 232 and the outlet channel 234 are in fluid communication via a channel or mixing chamber 236. For example, the inlet channel 232 is in fluid communication with the inlet 228 and the mixing chamber 236, and the outlet channel 234 is in fluid communication with the mixing chamber 236 and the outlet 230. In one embodiment, the dry anticoagulant powder 220 is disposed within the mixing chamber 236 of the housing 214. In one embodiment, the dry anticoagulant powder 220 is deposited on an inner surface 260 of the housing 214.

[0057] 8, in one embodiment, the housing 214 of the sample mixing and transfer device 200 includes a distribution or storage chamber 238. The distribution chamber 238 may be adjacent to the outlet 230 of the sample mixing and transfer device 200. For example, the distribution chamber 238 may be located between the mixing chamber 236 and the outlet 230.

[0058] In one embodiment, the sample mixing and transfer device 200 includes a mixing element 215 disposed within a housing 214. In one embodiment, the mixing element 215 includes a plurality of posts 270. For example, the mixing chamber 236 can include a plurality of posts 270 that obstruct the flow path of the blood sample, thereby promoting mixing between the blood sample and the dry anticoagulant powder 220.

[0059] 7 and 8, sample mixing and transfer device 200 is adapted to receive sample 212 therein via first end 222. For example, housing 214 of sample mixing and transfer device 200 is adapted to receive sample 212 therein via inlet 228. Sample 212 flows into inlet 228 and into inlet channel 232. In some embodiments, sample 212 may be a blood sample.

[0060] With the blood sample received in the inlet channel 232, the blood sample flows into the mixing chamber 236. As the blood sample flows into the mixing chamber 236, it mixes with the dried anticoagulant powder 220 deposited on the inner surface 260 of the housing 214. The mixing chamber 236 may include a plurality of posts 270 that obstruct the flow path of the blood sample, thereby promoting mixing between the blood sample and the dried anticoagulant powder 220. After mixing, the blood sample and the dried anticoagulant powder 220, i.e., the stabilized blood sample, move to the outlet channel 234.

[0061] In other embodiments, other portions of the sample mixing and transport device 200 may also include a mixing element 215 that obstructs the flow path of the blood sample, thereby promoting mixing between the blood sample and the dry anticoagulant powder 220.

[0062] Referring to FIG. 10, an alternative embodiment of the sample mixing and transfer device of the present disclosure is shown.

[0063] 11A-16 illustrate another exemplary embodiment of a material according to the present disclosure. Material 502 includes pores 505 and has dry anticoagulant powder 504 within the pores 505 of material 502, as described above. In one embodiment, material 502 is a sponge material. In another embodiment, material 502 is an open-cell foam. In one embodiment, the open-cell foam is treated with an anticoagulant to form dry anticoagulant powder 504 that is finely distributed throughout the pores 505 of material 502, as described in detail above.

[0064] In one embodiment, the substance 502 is an open-cell foam. For example, the substance 502 is a soft, deformable open-cell foam that is inert to blood. In one embodiment, the open-cell foam can be a melamine foam, such as Basotect®, available from BASF®. In another embodiment, the open-cell foam can be made of a formaldehyde-melamine-sodium bisulfite copolymer. The open-cell foam can also be a flexible, hydrophilic open-cell foam that is resistant to heat and many organic solvents. In one embodiment, the open-cell foam can be a sponge material.

[0065] 11A-16, substance 502 can be used with syringe assembly 500. Syringe assembly 500 can include open-cell foam substance 502 having dry anticoagulant powder 504 therein. Open-cell foam substance 502 is disposed within syringe assembly 500. Anticoagulant can be dispensed into open-cell foam substance 502 having pores 505, as described above.

[0066] In one embodiment, syringe assembly 500 includes a syringe barrel 506 having a first end 508, a second end 510, and a sidewall 512 extending therebetween to define an interior 514. With reference to Figures 11A-11C and 15, an open-cell foam material 502 is disposed in interior 514 of syringe barrel 506.

[0067] In one embodiment, the syringe assembly 500 includes a plunger rod 516 and a stopper 518. The plunger rod 516 includes a first end 520 and a second end 522. The stopper 518 engages the second end 522 of the plunger rod 516 and is slidably disposed within the interior 514 of the syringe barrel 506. The stopper 518 is sized relative to the interior 514 of the syringe barrel 506 to provide a sealing engagement with the sidewall 512 of the syringe barrel 506.

[0068] Open-cell foam 502 is placed within syringe barrel 506 to mix and stabilize the blood. The blood becomes collected in syringe barrel 506 with open-cell foam 502 embedded within syringe barrel 506. The stabilized blood can then be dispensed for analysis. In one embodiment, syringe assembly 500 is an arterial blood gas syringe and the stabilized blood can be dispensed for blood gas analysis.

[0069] In one embodiment, syringe assembly 500 acts as a flow-through chamber for effective mixing of a blood sample having dry anticoagulant powder 504 within open-cell foam material 502. In other embodiments, open-cell foam material 502 can include other dry substances. Effective mixing is achieved by passing the blood sample through open-cell foam material 502 having dry anticoagulant powder 504 distributed throughout its microstructure.

[0070] Referring to Figure 13, there is shown a diagram of the microstructure of an open-cell foam 502 having dry anticoagulant powder 504 distributed throughout its microstructure. Referring to Figure 14, there is shown a diagram of the microstructure of an untreated foam 502. Referring to Figure 16, there is shown a graph illustrating the uptake of anticoagulant by a blood sample flowing through an open-cell foam having dry anticoagulant powder distributed throughout its microstructure.

[0071] 17-20 illustrate exemplary embodiments of the sample mixing and transfer system of the present disclosure. Referring to FIGURES 17-20, in one embodiment, blood transfer system 600 includes syringe assembly 602, line 604, and container 606. In one embodiment, container 606 contains blood 608.

[0072] In one embodiment, line 604 includes an open-cell foam 612 having dry anticoagulant powder 614 therein. The anticoagulant can be added within the porous open-cell foam 612, as described above. Open-cell foam 612 is disposed within line 604. Line 604 includes a first end 616 and a second end 618.

[0073] In one embodiment, syringe assembly 602 includes a syringe barrel 620 and a sidewall 622 that defines an interior 624. With reference to Figures 17-20, line 604 is adapted to place syringe assembly 602 in fluid communication with container 606. For example, first end 616 of line 604 can be in fluid communication with the contents of container 606, and second end 618 of line 604 can be in fluid communication with syringe assembly 602.

[0074] Open-cell foam 612 is disposed within line 604 to mix and stabilize the blood. In one embodiment, blood 608 is transferred through line 604 from container 606 to syringe barrel 620. For example, a blood sample, such as blood 608, passes through line 604 with open-cell foam 612 embedded within line 604 as the blood becomes collected within syringe barrel 620. In this manner, blood 608 is stabilized before entering syringe barrel 620. After stabilized blood 608 is contained within syringe barrel 620, stabilized blood 608 may then be dispensed for analysis.

[0075] In one embodiment, line 604 acts as a flow-through chamber for effective mixing of the blood sample with dry anticoagulant powder 614 within open-cell foam material 612. In other embodiments, open-cell foam material 612 can contain other dry substances. Effective mixing is achieved by passing the blood sample through open-cell foam material 612 having dry anticoagulant powder 614 distributed throughout its microstructure.

[0076] The present invention provides a material comprising pores, as described above, having a dry anticoagulant powder within the pores of the material. In one embodiment, the material is a sponge material. In another embodiment, the material is an open-cell foam. In one embodiment, the open-cell foam is treated with an anticoagulant, as described in detail above, to form a dry anticoagulant powder that is finely distributed throughout the pores of the material.

[0077] The present disclosure provides various applications and embodiments of the material. For example, in one embodiment, the sample mixing and transfer device of the present disclosure is adapted to receive a sample. The sample mixing and transfer device includes a housing, a pore-containing material disposed within the housing, and a dry anticoagulant powder within the pores of the material. In one embodiment, the material is a sponge material. In another embodiment, the material is an open-cell foam. In one embodiment, the open-cell foam is treated with an anticoagulant to form a dry anticoagulant powder finely distributed throughout the pores of the material. A blood sample may be received within the sample mixing and transfer device. The blood sample is exposed to and mixed with the anticoagulant powder while passing through the material.

[0078] The disclosed sample mixing and transfer device provides uniform, passive mixing of blood with anticoagulant under flow-through conditions. The disclosed sample mixing and transfer device can capture blood clots or other contaminants within the microstructure of the material and prevent them from dispensing to the diagnostic sample port. The disclosed sample mixing and transfer device enables a simple, low-cost design for passive flow-through blood stabilization. The disclosed sample mixing and transfer device allows for precisely controlled addition of anticoagulant into a material by immersing it in a solution of anticoagulant and water and then drying the material to form a finely dispersed, dry anticoagulant powder throughout the pores of the material.

[0079] The sample mixing and transfer devices of the present invention can provide an effective, passive blood mixing solution for applications where blood flows through a line. Such sample mixing and transfer devices are useful for small blood volumes, e.g., less than 50 μL or less than 500 μL, and / or where inertial forces, e.g., gravity-based inertial forces, are ineffective for bulk manual mixing, such as required for evacuated tubes, by inverting the blood collection container back and forth.

[0080] In other embodiments of the present disclosure, the materials may be utilized in a sample mixing and transfer system or syringe assembly, as described above.

[0081] While this disclosure has been described as having an exemplary design, the disclosure can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or practice in the art to which this disclosure pertains and which fall within the scope of the appended claims.

Claims

1. 1. A sample mixing and transfer device adapted to receive a blood sample and produce a stabilized blood sample without filtering out non-blood clots, comprising: a housing having a first end including an inlet, a second end including an outlet, a sidewall extending therebetween, a mixing chamber, an inlet passage in fluid communication with the inlet and the mixing chamber, and an outlet passage in fluid communication with the mixing chamber and the outlet; a material disposed within the housing, the material comprising pores; a dry anticoagulant powder disposed within the pores of the material; a distribution chamber fluidly connected to the outlet channel; A sample mixing and transfer device comprising:

2. 10. The sample mixing and transfer device of claim 1, wherein the blood sample dissolves and mixes with the dry anticoagulant powder while passing through the material.

3. 10. The sample mixing and transfer device of claim 1, wherein the housing is adapted to receive the blood sample therein via the first end.

4. 4. The sample mixing and transfer device of claim 3, wherein the substance obstructs the flow of the blood sample when the blood sample is received in the housing to facilitate mixing of the blood sample with the dry anticoagulant powder.

5. The sample mixing and transfer device of claim 1 , wherein the substance is a sponge material.

6. The sample mixing and transfer device of claim 1 , configured so that the blood sample accumulates in the distribution chamber after passing through the mixing chamber.

7. 10. The sample mixing and transfer device of claim 1, wherein the sample mixing and transfer device is configured to transfer the blood sample to a diagnostic instrument.

8. 10. The sample mixing and transfer device of claim 1, wherein the sample mixing and transfer device is configured to receive small blood volumes in the range of less than 50 μL.

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