Biological fluid separation device

Abstract

Disclosed herein are biological fluid separation devices and separation processes that allow for efficient separation of plasma from a blood sample. The biological fluid separation device of the present disclosure is adapted to receive a blood sample having a cellular fraction, a cellular and plasma fraction, or plasma. The biological fluid separation device of the present disclosure utilizes a track-etched membrane and cross-flow filtration to separate plasma from cells.

Description

[0001] This divisional application is a divisional application based on the patent application with Chinese invention patent application number 201880037854.3 (international application number PCT / US2018 / 036511), invention name “Biological fluid separation device” and application date June 7, 2018. Technical Field

[0002] The present disclosure relates generally to devices suitable for use with biological fluids. More particularly, the present disclosure relates to devices suitable for separating components of biological fluids. Background Art

[0003] Blood sampling is a common healthcare procedure that involves drawing at least one drop of blood from a patient. Blood samples are typically collected from hospitalized, home care, and emergency room patients via finger prick, heel prick, or venipuncture. Blood samples can also be collected from patients via a venous or arterial line. Once collected, blood samples can be analyzed to obtain medically useful information, including, for example, chemical composition, hematology, or coagulation.

[0004] Blood tests determine the patient's physiological and biochemical status, such as disease, mineral content, drug efficacy, and organ function. Blood tests can be performed in a clinical laboratory or at a point of care near the patient. An example of a point-of-care blood test is a routine test of a patient's blood glucose level, which involves drawing blood via a finger prick and mechanically collecting the blood into a diagnostic cartridge. Thereafter, the diagnostic cartridge analyzes the blood sample and provides the clinician with a reading of the patient's blood glucose level. Other devices can also be used to analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. Some other point-of-care devices can identify markers for acute coronary syndrome (ACS) and deep vein thrombosis / pulmonary embolism (DVT / PE).

[0005] A blood sample contains a cellular portion (blood cells) and a plasma portion (i.e., plasma). Core lab testing involves a large number of blood tests in which the plasma is separated from the blood cells using centrifugation before the test tube is presented to a large diagnostic instrument for laboratory analysis. Centrifugation is a commonly accepted plasma separation process commonly used in many laboratory tests. Centrifugation typically takes 15 to 20 minutes and involves heavy labor or complicated workflows.

[0006] In a point-of-care setting, a blood sample is presented to the instrument at or near the patient's bedside. Most point-of-care tests use whole blood samples transferred from a blood collection tube via a pipette or syringe because plasma samples are not available at the patient's bedside. Summary of the Invention

[0007] The present disclosure provides a biological fluid separation device and a separation process that allows for efficient separation of plasma from a blood sample. The biological fluid separation device of the present disclosure is adapted to receive a blood sample having a cellular fraction (or cells) and a plasma fraction (or plasma). The biological fluid separation device of the present disclosure uses a track-etched membrane and cross-flow filtration to separate plasma from cells.

[0008] In one embodiment, the biological fluid separation device of the present disclosure provides a plasma separation device integrated into an evacuated blood collection tube. Advantageously, the biological fluid separation device of the present disclosure provides for immediate separation of plasma during a clinical blood draw, and the ability to dispense the separated plasma sample into a point-of-care cartridge or other diagnostic instrument port or test device in a controlled manner. The biological fluid separation device of the present disclosure provides a blood collection workflow that is comparable to that of blood collection devices using vacuum tubes (e.g., BD FLUID). ) and a conventional blood collection workflow using a corresponding venous access kit. The biological fluid separation device of the present disclosure produces plasma that can be immediately used for controlled distribution to diagnostic instruments at the point of care or in a near-patient diagnostic setting.

[0009] The biological fluid separation device of the present disclosure allows for immediate plasma separation during blood draw, thereby eliminating the need for a separate centrifugation process, and also allows for controlled transfer of plasma samples to a diagnostic port using the embedded precision drop dispenser of the present disclosure. The biological fluid separation device of the present disclosure eliminates the need for centrifugation of conventional blood collection tubes, which typically need to be sent to a laboratory for centrifugation.

[0010] According to one embodiment of the present invention, a biological fluid separation device is adapted to receive a blood sample having a first portion and a second portion. The biological fluid separation device includes a housing having an inlet and an outlet and a vent plug, and a blood chamber having a blood chamber inlet and a blood chamber outlet, wherein the blood chamber is adapted to receive the blood sample. The biological fluid separation device also includes a separation chamber having a chamber outlet and a separator disposed between the blood chamber and the separation chamber, the separator being adapted to retain the first portion in the blood chamber and allow the second portion to pass through the separator and into the separation chamber. The biological fluid separation device also includes an outer housing removably connected to the housing, wherein the outer housing contains a first vacuum, the housing contains a second vacuum, and wherein the housing is connected to the outer housing and the housing is disposed within the outer housing. The first vacuum and the second vacuum are in communication via the vent plug.

[0011] In one configuration, the first portion is a cellular portion and the second portion is a plasma portion.The first vacuum and the second vacuum can draw the blood sample within the housing and draw the plasma portion through the separator into the separation chamber.

[0012] In certain configurations, the separator may comprise a membrane surface having pores. Optionally, the separator is a track-etched membrane.

[0013] The biological fluid separation device may further include a closure covering the inlet and, when the housing is connected to the outer housing, the closure may seal the open end of the housing. The inlet of the housing may be disposed at a first end, and the outlet of the housing may be disposed at an opposite second end.

[0014] In other configurations, the biological fluid separation device can further include a plasma collection channel between the chamber outlet and the housing outlet. Optionally, the plasma collection channel can have a serpentine shape.

[0015] In other configurations, the biological fluid separation device may further include a dispenser assembly including a cap covering the outlet and including a vent plug that allows air to pass therethrough and prevents the second portion of the blood sample from passing therethrough. The dispenser assembly may further include a deformable portion that is transitionable between an initial position, in which the second portion is contained within the separation chamber, and a deformed position, in which a portion of the second portion is expelled from the separation chamber. As the cap is removed from the outlet and the deformable portion transitions to the deformed position, a portion of the second portion may be expelled from the biological fluid separation device.

[0016] In other configurations, the biological fluid separation device can include a diagnostic assembly comprising a diagnostic port in communication with a chamber outlet of the separation chamber and a sensor for testing the second portion.

[0017] According to another embodiment of the present invention, a biological fluid separation device adapted to receive a blood sample having a cellular portion and a plasma portion may include an inner housing having an inlet and an outlet. The biological fluid separation device may further include a blood chamber and a plasma chamber, the blood chamber having a blood chamber inlet and a blood chamber outlet, wherein the blood chamber receives the blood sample and the plasma chamber has a plasma chamber outlet. The biological fluid separation device may further include a separator disposed between the blood chamber and the plasma chamber, and an outer housing removably connected to the inner housing, the separator being adapted to capture the cellular portion in the blood chamber and allow the plasma portion to pass through the separator into the plasma chamber. With the inner housing connected to the outer housing, the inner housing may be disposed within the outer housing, and wherein a vacuum is defined by at least one of the inner housing and the outer housing to draw the plasma portion of the blood sample through the separator.

[0018] The biological fluid separation device may further include a biological fluid separation device connector that is removably connectable to a connector of the blood collection tube. Optionally, the outer housing of the biological fluid separation device may include an evacuation tube.

[0019] According to another embodiment of the present invention, a biological fluid separation device can be adapted to receive a blood sample having a cellular portion and a plasma portion. The biological fluid separation device can include an outer housing having an open end, a closed end, and a sidewall, the sidewall extending between the open end and the closed end and defining an interior. The biological fluid separation device can also include a distributor unit removably connectable to the outer housing, and an inner housing within the outer housing. The inner housing can include a blood chamber having a blood chamber inlet and a blood chamber outlet, the blood chamber being configured to receive a blood sample, the blood chamber outlet being in fluid communication with a portion of the outer housing interior. The biological fluid separation device also includes a plasma chamber having a plasma chamber outlet, and a separator disposed between the blood chamber and the plasma chamber. The separator can be adapted to retain the cellular portion in the blood chamber and allow the plasma portion to pass through the separator into the plasma chamber. The biological fluid separation device also includes a plasma collection channel extending from the plasma chamber outlet to the distributor unit.

[0020] Optionally, the biological fluid separation device can further include a stopper sized relative to the interior of the outer housing to provide a sealed engagement with a sidewall of the outer housing. The stopper can divide the interior of the outer housing into a first sealed portion and a second portion. In certain configurations, the dispenser unit is disconnected from the outer housing, and the plasma portion is contained within the dispenser unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and other features and advantages of the present disclosure and the manner in which they are achieved will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0022] Figure 1 is a perspective view of a biological fluid separation device according to one embodiment of the present invention.

[0023] Figure 2 According to one embodiment of the present invention, Figure 1 A cross-sectional view taken along line 2-2.

[0024] Figure 3A is a perspective view of a biological fluid separation device according to one embodiment of the present invention.

[0025] Figure 3B is an exploded perspective view of a biological fluid separation device according to one embodiment of the present invention.

[0026] Figure 3C is an exploded perspective view of a biological fluid separation device according to one embodiment of the present invention.

[0027] Figure 3D is an exploded perspective view of a dispenser assembly of a biological fluid separation device according to one embodiment of the present invention.

[0028] Figure 3E FIG. 4 is an exploded perspective view of a separator chip of a biological fluid separation device according to an embodiment of the present invention.

[0029] Figure 3F FIG. 1 is an enlarged partial cross-sectional view of a separator of a biological fluid separation device according to one embodiment of the present invention.

[0030] Figure 3G FIG. 1 is an enlarged partial cross-sectional view of a separator of a biological fluid separation device according to one embodiment of the present invention.

[0031] Figure 4A is a perspective view of a first step in using a biological fluid separation device of the present disclosure, according to one embodiment of the present invention.

[0032] Figure 4B is a perspective view of a second step of using the biological fluid separation device of the present disclosure, according to one embodiment of the present invention.

[0033] Figure 4C is a perspective view of a third step of using the biological fluid separation device of the present disclosure, according to one embodiment of the present invention.

[0034] Figure 4D is a perspective view of a dispensing step using a biological fluid separation device of the present disclosure, according to one embodiment of the present invention.

[0035] Figure 4E is a perspective view of a dispensing step using a biological fluid separation device of the present disclosure, according to one embodiment of the present invention.

[0036] Figure 4F is a perspective view of an inner housing of a biological fluid separation device according to one embodiment of the present invention.

[0037] Figure 5 is a perspective view of a biological fluid separation device according to another embodiment of the present invention.

[0038] Figure 6 According to another embodiment of the present invention, Figure 5 A cross-sectional view taken along line 6-6.

[0039] Figure 7A is a perspective view of a first step in using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0040] Figure 7B is a perspective view of a second step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0041] Figure 7Cis a perspective view illustrating a dispensing step using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0042] Figure 7D is a perspective view illustrating a dispensing step using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0043] Figure 8 is a perspective view of a biological fluid separation device according to another embodiment of the present invention.

[0044] Figure 9 According to another embodiment of the present invention, Figure 8 A cross-sectional view taken along line 9-9.

[0045] Figure 10A is a perspective view of a first step in using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0046] Figure 10B is a perspective view of a second step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0047] Figure 10C According to another embodiment of the present invention Figure 10B Zoomed-in views of different sensor configurations.

[0048] Figure 10D is a perspective view of a third step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0049] Figure 11A is a perspective view of a first step of using a biological fluid separation device of the present disclosure during a direct aspiration process according to another embodiment of the present invention.

[0050] Figure 11B is a perspective view of a second step of using the disclosed biological fluid separation device during direct aspiration according to another embodiment of the present invention.

[0051] Figure 12A is a perspective view of a first step in using a biological fluid separation device of the present disclosure during an indirect aspiration process according to another embodiment of the present invention.

[0052] Figure 12B is a perspective view of a second step of using the disclosed biological fluid separation device in an indirect aspiration process according to another embodiment of the present invention.

[0053] Figure 12C is a perspective view of a third step of using the disclosed biological fluid separation device in an indirect aspiration process according to another embodiment of the present invention.

[0054] Figure 13 is a perspective view of a biological fluid separation device according to another embodiment of the present invention.

[0055] Figure 14 According to another embodiment of the present invention Figure 13 Cross-sectional view of .

[0056] Figure 15 According to another embodiment of the present invention Figure 13 Cross-sectional view of .

[0057] Figure 16A is a perspective view of a first step in using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0058] Figure 16B is a perspective view of a second step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0059] Figure 16C is a perspective view of a third step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0060] Figure 17A is a perspective view of a first step in using a biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0061] Figure 17B is a perspective view of a second step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0062] Figure 17C is a perspective view of a third step of using the biological fluid separation device of the present disclosure according to another embodiment of the present invention.

[0063] Corresponding reference characters indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure and are not to be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0064] The following description is provided to enable those skilled in the art to make and use the embodiments contemplated for practicing the present invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0065] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the present invention as oriented as shown in the figures. However, it should be understood that the present invention may assume alternative variations and step sequences unless expressly stated to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely illustrative embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered as limiting.

[0066] Figure 1-4E An exemplary embodiment of a biological fluid separation device of the present disclosure is shown. Figure 1-4E The biological fluid separation device 10 of the present disclosure is adapted to receive a blood sample 12 having a first portion, such as a cell portion 14, and a second portion, such as a plasma portion 16. The biological fluid separation device and separation process provided by the present disclosure allow for efficient separation of plasma from a blood sample.

[0067] In one embodiment, the biological fluid separation device of the present disclosure provides a plasma separation device integrated into an evacuated blood collection tube. Advantageously, the biological fluid separation device of the present disclosure provides immediate separation of plasma during a clinical blood draw and provides the ability to dispense the separated plasma sample into a point-of-care cartridge or other diagnostic instrument port or test device in a controlled manner. The biological fluid separation device of the present disclosure provides a blood collection workflow that is comparable to that of blood collection devices using vacuum tubes (e.g., BD FLUID). ) and a conventional blood collection workflow using a corresponding venous access kit. The biological fluid separation device of the present disclosure produces plasma that is immediately available for controlled distribution to diagnostic instruments at the point of care or in near-patient diagnostic settings.

[0068] The biological fluid separation device of the present disclosure allows for immediate plasma separation during blood draw, thereby eliminating the need for a separate centrifugation process and allowing for controlled transfer of plasma samples to a diagnostic port using the embedded precision drop dispenser of the present disclosure. The biological fluid separation device of the present disclosure eliminates the need for centrifugation of conventional blood collection tubes, which typically need to be sent to a laboratory for centrifugation.

[0069] refer to Figure 1-4E In an exemplary embodiment, biological fluid separation device 10 generally includes an inner housing or tube 20 , an outer housing or tube 22 , and a separator 24 .

[0070] refer to Figure 1-4EThe inner housing 20 includes an inlet 30, an outlet 32, a blood chamber 34 for receiving the blood sample 12, a separation chamber (e.g., a plasma chamber 36), and a separator 24. In one embodiment, the inlet 30 of the inner housing 20 is at a first end, and the outlet 32 ​​of the inner housing 20 is at an opposite second end. In other embodiments, the configuration of the inlet 30 and the outlet 32 ​​can be varied for different applications.

[0071] Reference Figure 1-4E , the blood chamber 34 receives the blood sample 12 and includes a blood chamber inlet 40, a blood chamber outlet 42, and a blood chamber passage 44 extending between the blood chamber inlet 40 and the blood chamber outlet 42. In one embodiment, the blood chamber inlet 40 is in fluid communication with the inlet 30 of the biological fluid separation device 10. In one embodiment, the blood chamber 34 also includes a blood waste chamber 45 in fluid communication with the blood chamber outlet 42. In this manner, the cellular portion 14 of the blood sample 12 can be removed and stored in the blood waste chamber 45 after flowing through the blood chamber passage 44 and passing through the separator 24. The plasma chamber 36 includes a plasma chamber outlet 46.

[0072] refer to Figure 1-4E , the separator 24 is disposed between the blood chamber 34 and the plasma chamber 36. In one embodiment, the separator 24 is adapted to retain the cellular portion 14 of the blood sample 12 in the blood chamber 34 and allow the plasma portion 16 of the blood sample 12 to pass through the separator 24 into the plasma chamber 36.

[0073] In one embodiment, the separator 24 includes a membrane surface 50 having pores or filter holes 52. The membrane surface 50 has a first or blood side 54 and a second or plasma side 56. Figure 3E , the blood chamber channel 44 is parallel to the membrane surface 50, as discussed in more detail below.

[0074] In one embodiment, the separator 24 comprises a track-etched membrane. The biological fluid separation device 10 of the present disclosure uses a track-etched membrane and cross-flow filtration to separate plasma 16 from cells 14. The track-etched membrane of the biological fluid separation device 10 is a filter with pores small enough to prevent red blood cells or cells from flowing through, but allows plasma to flow through. The flow of plasma through the membrane is driven by the pressure on both sides of the membrane (i.e., transmembrane pressure), but this flow also carries cells to the membrane surface and risks membrane clogging. This is prevented by continuous blood flow parallel to the membrane surface (i.e., cross-flow filtration), which washes away the cells and allows continuous plasma filtration.

[0075] In one embodiment, the biological fluid separation device 10 of the present disclosure controls the blood flow rate on one side of the track-etched membrane (i.e., the first or blood side 54), while the pressure differential across the track-etched membrane draws plasma 16 to the other side of the track-etched membrane, i.e., the second or plasma side 56, as shown in FIG. Figure 3E and 3F As shown, the blood sample 12 that has fallen into the blood chamber 34 flows within the blood chamber channel 44 parallel to the membrane surface 50 of the separator 24. In this manner, this parallel flow prevents cells 14 of the blood sample 12 from clogging the pores 52 of the separator 24. The submicron pores 52 of the separator 24 allow the plasma 16 to flow to the other side, i.e., the plasma side 56, and further out into the plasma chamber 36.

[0076] In one embodiment, the separator 24 includes a track-etched membrane having submicron pores 52 to filter plasma 16 from the blood sample 12 that continuously flows parallel to the membrane surface 50. In this way, clogging of the filter pores 52 is prevented, such as Figure 3F Advantageously, the separation process of the present disclosure does not continuously trap cells within the filter structure, ultimately reducing the yield to zero.

[0077] The biological fluid separation device 10 of the present disclosure is designed to effectively separate blood cells from plasma without subjecting the cells to damage, such as cell disruption known as hemolysis. The biological fluid separation device 10 of the present disclosure balances essential blood flow characteristics in a manner that maximizes plasma yield within a given time while maintaining cell integrity. In some embodiments, the biological fluid separation device 10 of the present disclosure is designed by mathematically modeling each component of the filtration system, for example using an equivalent circuit approach, to determine critical flow rates and geometric parameters that maximize yield, minimize separation time, and minimize hemolysis.

[0078] In one embodiment, separator 24 comprises a track-etched membrane having a thickness of less than 100 microns. In one embodiment, separator 24 comprises a track-etched membrane having a thickness of 5-25 microns. In another embodiment, separator 24 comprises a track-etched membrane having a thickness of 6-14 microns.

[0079] In one embodiment, the diameter of the submicron pores 52 of the track-etched membrane is approximately 0.1-1.0 microns. In another embodiment, the diameter of the submicron pores 52 of the track-etched membrane is approximately 0.2-0.8 microns.

[0080] In one embodiment, the effective filtration surface area of ​​the track-etched membrane is less than 40 mm 2 Advantageously, this allows the separator 24 of the present invention to fit within conventional blood collection tubes and yet produce high quality plasma with minimal analyte bias, particularly low bias for cardiac markers such as troponin and BNP.

[0081] refer to Figure 3E In one embodiment, the separator 24, the blood chamber 34, and the plasma chamber 36 form a separator chip 58. In one embodiment, the separator chip 58 is sized to be contained within the inner housing 20.

[0082] In one embodiment, the separator chip 58 has a chip length of approximately 9-125 mm. In one embodiment, the separator chip 58 has a chip width of approximately 8-16 mm. In one embodiment, the separator chip 58 has a chip thickness of approximately 0.5-2 mm.

[0083] In one embodiment, the height of the blood chamber 34 is approximately 30-200 microns. In one embodiment, the length of the blood chamber 34 is approximately 5-121 microns. In one embodiment, the height of the plasma chamber 36 is approximately 60-1000 microns.

[0084] In one embodiment, the biological fluid separation device 10 of the present disclosure includes an outer housing 22 that is removably connectable to the inner housing 20. Figure 1-3A , with inner housing 20 connected to outer housing 22, inner housing 20 is disposed within outer housing 22. Outer housing 22 includes an open end 70, a closed end 72, and a sidewall 74 extending between open end 70 and closed end 72 and defining an interior 76. In one embodiment, outer housing 22 contains a first vacuum 78.

[0085] refer to Figure 1-3C In one embodiment, the biological fluid separation device 10 includes a closure member 60 covering the inlet 30. Figure 1-3C The closure 60 is engaged with the inlet 30 to seal the biological fluid separation device 10. The closure 60 protectively covers the inlet 30. The closure 60 allows the blood sample 12 to be introduced into the blood chamber 34 of the inner housing 20 and can include a pierceable self-sealing plug 62 having an outer shield 64, such as Hemogard available from Becton, Dickinson and Company. TM In one embodiment, the closure 60 includes a plug adapter 66 .

[0086] refer to Figure 1-3C In one embodiment, the outer housing 22 can be removably coupled to the inner housing 20 via a closure 60. For example, the closure 60 is fixed to the outer housing 22. In this manner, the inner housing 20 is coupled to the outer housing 22, and the closure 60 seals the open end 70 of the outer housing 22.

[0087] In one embodiment, the outer shell 22 is an evacuated tube. In one embodiment, the outer shell 22 can be a blood collection tube containing a vacuum, such as those available from Becton, Dickinson and Company. Blood collection tubes.

[0088] refer to Figure 1-3C In one embodiment, the inner housing 20 includes a cap 80 that is removably attachable to and protectively covers the outlet 32. In one embodiment, the cap 80 includes a vent plug 82 that allows air to pass therethrough and prevents the plasma 16 of the sample 12 from passing therethrough.

[0089] The cap 80 and vent plug 82 are configured to allow air to pass through the cap 80 while preventing the plasma 16 of the blood sample 12 from passing through the cap 80, and may include a hydrophobic filter. The vent plug 82 has a selected resistance to air passage that can be used to finely control the filling rate of the blood chamber 34 and / or plasma chamber 36 of the inner housing 20. By varying the porosity of the vent plug 82, the rate at which air flows out of the cap 80 can be controlled, thereby controlling the rate at which the blood sample flows into the inner housing 20.

[0090] refer to Figure 1-3C In one embodiment, the outer housing 22 contains the first vacuum 78 and the inner housing 20 contains the second vacuum 38. In one embodiment, the first vacuum 78 and the second vacuum 38 are connected via a vent plug 82. In other embodiments, the inner housing 20 may further include a second vent plug and / or a vent plug valve 84 that allows the first vacuum 78 and the second vacuum 38 to be connected together.

[0091] The first vacuum 78 and the second vacuum 38 draw the blood sample 12 within the inner housing 20 and draw the plasma portion 16 through the separator 24 into the plasma chamber 36 , as described in more detail below.

[0092] In one embodiment, the vent plug 82 of the cap 80 (which allows air to pass therethrough and prevents the plasma 16 of the sample 12 from passing therethrough) seals the plasma chamber 36 once the plasma 16 wets the vent plug 82 and the separation ends.

[0093] refer to Figure 1-4F In one embodiment, the inner housing 20 of the biological fluid separation device 10 includes a dispenser assembly or unit 90 that allows the plasma 16 contained within the plasma collection channel 48 to be discharged in a precise, controlled, and efficient manner.

[0094] refer to Figure 1-4FIn one embodiment, the inner housing 20 includes a plasma collection channel 48 between the plasma chamber outlet 46 and the outlet 32 ​​of the inner housing 20. Thus, after separation, the plasma 16 flows through the plasma chamber outlet 46 to the plasma collection channel 48. The plasma collection channel 48 allows the plasma 16 to be collected and stored within the inner housing 20 until it is desired to transfer the plasma 16 out of the inner housing 20.

[0095] In one embodiment, the plasma collection channel 48 has a serpentine shape. The diameter of the serpentine shape of the plasma collection channel 48 is sized to prevent the formation of bubbles in the plasma 16 and to maintain the plasma 16 flowing through the channel 48 in a capillary form. The serpentine shape of the plasma collection channel 48 also allows the length of the channel into which the plasma 16 flows to be increased while maintaining the capillary form.

[0096] refer to Figure 1-4F In one embodiment, the inner housing 20 further includes a dispenser assembly or dispenser unit 90 that allows the plasma 16 contained within the plasma collection channel 48 to be discharged in a precise, controlled, and efficient manner. For example, once a sufficient amount of plasma 16 has been collected within the plasma collection channel 48, the inner housing 20 can be removed from the outer housing 22, as shown. Figure 4C Next, the cap 80 is removed from the outlet 32 ​​and the dispenser assembly 90 is used to dispense the plasma 16 from the plasma collection channel 48 of the inner housing 20, as shown. Figure 4D and 4E shown.

[0097] The dispenser assembly 90 of the inner housing 20 may include any dispenser structure that allows the plasma 16 to be discharged from the plasma collection channel 48 of the inner housing 20 in a precise, controlled, and efficient manner.

[0098] refer to Figure 3C and 3D , an exemplary embodiment of a distributor assembly 90 will be described. In one embodiment, the distributor assembly 90 includes a plasma collection channel 48, a cap 80, a vent plug 82, a deformable portion 92, a vent 96, and a one-way valve 98. In one embodiment, the deformable portion 92 includes a first distributor balloon 93 and a second distributor balloon 94.

[0099] In one embodiment, the cap 80 covers the outlet 32 ​​and includes a vent plug 82 that allows air to pass therethrough and prevents the plasma portion 16 of the blood sample 12 from passing therethrough.

[0100] In one embodiment, the deformable portion 92 is capable of transitioning between an initial position in which the plasma portion 16 is contained within the plasma collection channel 48 and a deformed position in which a portion of the plasma portion 16 is expelled from the plasma collection channel 48. Figure 4D and 4EAs the cap 80 is removed from the outlet 32 ​​and the deformable portion 92 transitions to the deformed position, a portion of the plasma portion 16 is discharged from the biological fluid separation device 10, i.e., the plasma collection channel 48 of the inner housing 20. In one embodiment, the deformable portion 92 includes a first distributor balloon 93 and a second distributor balloon 94.

[0101] In use, when the deformable portion 92 is squeezed, air is pushed within the inner housing 20 to expel the plasma 16 from the plasma collection channel 48. In one embodiment, when the deformable portion 92 is squeezed, the vent 96 on the deformable portion 92 is covered by the user's finger, forcing air through the one-way valve 98, thereby expelling the plasma 16 from the plasma collection channel 48.

[0102] When the deformable portion 92 is released, the vent 96 is no longer covered, and the air inflates the deformable portion 92 back. Importantly, when the deformable portion 92 is released, the one-way valve 98 prevents the plasma 16 from being drawn back into the plasma collection channel 48 after dispensing. In this manner, the dispensing assembly 90 of the present disclosure ensures that the plasma 16 contained within the plasma collection channel 48 can only flow in one direction, i.e., out of the plasma collection channel 48.

[0103] refer to Figure 5-7D In another exemplary embodiment, the plasma chamber outlet 46 of the inner housing 20 is in fluid communication with a portion of the interior 76 of the outer housing 22. In such an embodiment, reference is made to Figure 1-4F The dispensing assembly 90 of the inner housing 20 of the discussed embodiment is removed, and the plasma 16 is allowed to flow directly out of the plasma chamber outlet 46 into a portion of the interior 76 of the outer housing 22 .

[0104] refer to Figure 7A In this embodiment, when the blood sample 12 is drawn into the inner housing 20, the plasma 16 is separated and exits the plasma chamber outlet 46 and is collected in the outer housing 22. Figure 7B , the discarded cellular portion 14 of the blood sample 12 remains within the inner housing 20 and can be disposed of after the plasma 16 is separated. Figure 7C and 7D The plasma 16 contained within the outer housing 22 may then be manually transferred or presented directly to a clinical analyzer.

[0105] In operation, when the inner shell 20 is filled, Figure 1-4F Plasma production is stopped in the illustrated embodiment having a plasma collection unit or dispensing assembly 90 that allows collection of plasma 16 within the inner housing 20 .

[0106] Blood draw and plasma volumes vary from patient to patient because more or less blood is needed to fill the plasma collection unit. Figure 5-7D The plasma collection unit in the illustrated embodiment allows for the generation of additional plasma beyond the capacity of the collection unit. This provides the benefit of increased plasma volume (from 300-700 μL for 3 mL of whole blood, depending on the patient's hematocrit, compared to a plasma collection unit which may be limited to, for example, 150-250 liters). Figure 5-7D Another benefit of the illustrated embodiment is that the plasma 16 sample can be presented directly to the clinical analyzer or manually dispensed as the workflow requires.

[0107] exist Figure 5-7D In the embodiment shown, the blood draw volume can be increased to a stable 3 ml for all patients, rather than varying between patients. Thus, the plasma separation time can be increased proportionally with the increase in blood draw volume. To mitigate the effect of increased run time, as Figures 12A-12C As shown, Figure 5-7D The illustrated embodiments may be combined with off-patient isolation methods, as described in more detail below.

[0108] refer to Figure 8-10D In another exemplary embodiment, the plasma chamber outlet 46 of the inner housing 20 is in fluid communication with the diagnostic assembly 200. In such an embodiment, reference is made to Figure 1-4F The dispensing assembly 90 of the inner housing 20 of the discussed embodiment is removed, and the plasma 16 is allowed to flow directly out of the plasma chamber outlet 46 into the diagnostic assembly 200. In such an embodiment, the plasma 16 fills the diagnostic assembly 200 for testing the plasma 16 for analytes immediately after separation without dispensing any plasma 16 from the biological fluid separation device 10.

[0109] In one embodiment, the diagnostic assembly 200 includes a diagnostic interface 202 in communication with the plasma chamber outlet 46, a sensor 204 for testing the plasma portion 16 of the blood sample 12, and a vent plug 206 that allows air to pass therethrough and prevents the plasma portion 16 of the blood sample 12 from passing therethrough.

[0110] refer to Figure 10C In one embodiment, the diagnostic assembly 200 includes a single sensor 204. Figure 10C In one embodiment, the diagnostic component 200 includes three sensors 204. Figure 10C In one embodiment, the diagnostic component 200 includes a number of sensors 204. The diagnostic component 200 may include any number of sensors 204 required for a desired testing application.

[0111] In one embodiment, the vent plug 206 of the diagnostic assembly 200 allows the vacuum to draw the plasma 16 into the diagnostic interface 202 and fill the diagnostic assembly 200. For example, the vent plug 206 allows the vacuum 78 of the outer housing 22 to communicate with the diagnostic assembly 200 to draw the plasma 16 into the diagnostic assembly 200. The vent plug 206 allows air to pass through it while preventing the plasma 16 of the blood sample 12 from passing through. For example, once the plasma 16 fills the diagnostic assembly 200, the vent plug 206 becomes saturated with blood and soaked. Once this occurs, the diagnostic assembly 200 is filled with plasma 16, and no more plasma 16 is drawn into the diagnostic assembly 200. With the diagnostic assembly 200 completely filled with plasma 16 and the vent plug 206 soaked, the diagnostic assembly 200 is also sealed.

[0112] refer to Figure 8-10D , the diagnostic assembly 200 provides an onboard diagnostic unit for testing the plasma 16 for analytes immediately after separation. The diagnostic assembly 200 will utilize, but is not limited to, optical testing and other methods. Possible applications include qualitative "yes or no" testing for the presence of an analyte, such as similar to a common pregnancy test, as well as quantitative results for analytes such as cholesterol or sodium. Reference Figure 10B In one embodiment, the onboard diagnostic component 200 can work alone. Figure 10D In one embodiment, the on-board diagnostic component 200 can interface with a test reader, such as a diagnostic adapter 208, such as a cell phone adapter, which connects the device 10 to a point-of-care diagnostic instrument 210, such as a cell phone camera, for imaging and analysis of sample results.

[0113] The diagnostic assembly 200 of the device 10 provides efficient point-of-care workflow and clinician safety by eliminating the need to transfer plasma 16 to a separate test cartridge. The diagnostic assembly 200 of the device 10 also reduces the required volume of plasma 16 required, for example, in some embodiments, from a range of 200-400 microliters of plasma to 10-50 microliters, which also reduces the run time of the device, for example, in some embodiments, from 50-140 seconds to 15-30 seconds, and can reduce the required blood volume, for example, in some embodiments, from 1-3 milliliters to 0.2-0.5 milliliters.

[0114] refer to Figures 4A-4FThe use of the biological fluid separation device 10 of the present disclosure will now be described. Advantageously, the biological fluid separation device 10 of the present disclosure allows for a variety of different ways to collect and separate the plasma portion of a blood sample. For example, in one embodiment, the biological fluid separation device 10 of the present disclosure can be used with a conventional tube holder 102 having a cannula or non-patient needle 100 during a direct aspiration procedure, as described in more detail below. In another embodiment, the biological fluid separation device 10 of the present disclosure can be used with a separate blood collection tube 130 during an indirect aspiration procedure, as described in more detail below.

[0115] refer to Figure 4A 、 Figure 4B and Figure 11A , the use of the biological fluid separation device 10 of the present disclosure with a conventional tube holder 102 having a cannula or non-patient needle 100 during a direct aspiration procedure will now be discussed. The biological fluid separation device 10 of the present disclosure is compatible with conventional blood collection sets, such as the tube holder 102 or other conventional blood collection devices.

[0116] In use, the needle cannula or non-patient needle 100 ( Figure 2 and 4A ) is directly inserted into the blood chamber 34 of the inner housing 20 of the biological fluid separation device 10 through the pierceable self-sealing plug 62 of the closure 60. Figure 4A and 4B As shown, the biological fluid separation device 10 including the combined inner housing 20 and outer housing 22 can be inserted into a conventional tube holder 102 having a cannula or non-patient needle 100 through which a biological fluid, such as a blood sample 12 , is passed.

[0117] Next, with the biological fluid separation device 10 of the present disclosure directly connected to the tube holder 102, the blood sample 12 is drawn from the conventional tube holder 102 into the blood chamber 34 of the inner housing 20 of the biological fluid separation device 10 by drawing the first vacuum 78 contained in the outer housing 22 and the second vacuum 38 contained in the inner housing 20. For example, when the non-patient needle 100 of the tube holder 102 pierces the stopper 62 of the closure 60, the first vacuum 78 contained in the outer housing 22 and the second vacuum 38 contained in the inner housing 20 draw the blood sample 12 within the blood chamber 34 of the inner housing 20 via the non-patient needle 100 of the tube holder 102.

[0118] The vent plug 82 and / or vent plug valve 84 allow air to pass therethrough while preventing the blood sample 12 and / or plasma portion 16 from passing therethrough. Once the blood sample 12 fills the separator chip 58, the first vacuum 78 and the second vacuum 38 are no longer connected and begin to function independently. The second vacuum 38 continues to discard the cellular portion 14 of the blood sample 12 from the blood chamber outlet 42 to the blood waste chamber 45. In addition, the first vacuum 78 continues to draw the plasma portion 16 into the plasma chamber 36 through the separator 24. Once the plasma portion 16 fills the plasma chamber 45 and reaches the vent plug 82, the vent plug will be saturated with blood and wetted, completing the separation. If desired, the first vacuum 78 and the second vacuum 38 can be connected by a vent plug valve 84, which allows air to pass between the first vacuum 78 and the second vacuum 38, but prevents the blood sample 12 from reaching the outer shell 22.

[0119] Thus, in one embodiment, the first vacuum 78 and the second vacuum 38 initially act together as a single vacuum, with the first vacuum 78 and the second vacuum 38 being connected together. Subsequently, after the separator chip 58 is filled with the blood sample 12, the first vacuum 78 and the second vacuum 38 are no longer connected together, but act independently. In another embodiment, the first vacuum 78 and the second vacuum 38 remain connected during operation via the vent stop valve 84.

[0120] Once the blood sample 12 is collected and the desired amount of plasma 16 is separated, the biological fluid separation device 10 is removed from the tube holder 102. Next, the separated plasma 16 is ready to be distributed and / or analyzed, as described in further detail below.

[0121] refer to Figures 12A-12C , the use of the biological fluid separation device 10 of the present disclosure with a separate blood collection tube 130 in an indirect aspiration procedure will now be discussed.

[0122] The indirect aspiration process allows plasma to be separated outside the patient. Figure 12A In this embodiment, during a conventional blood collection procedure, the blood sample 12 is collected in a conventional blood collection tube 130. Blood collection using a conventional blood collection tube 130 allows for faster collection of the blood sample 12 from the patient. In this way, the time the patient needs to undergo the blood collection procedure is reduced.

[0123] Next, refer to Figure 12B , the blood collection tube 130 containing the blood sample 12 is then connected to the biological fluid separation device 10 for separating the plasma 16 of the blood sample 12. In this manner, the biological fluid separation device 10 is used to separate the plasma 16 when no blood collection device is connected to the patient.

[0124] refer to Figure 12BIn one embodiment, the biological fluid separation device 10 includes a biological fluid separation device connector 140 that can be removably connected to the connector 132 of the blood collection tube 130. This connection provides a sealed, reliable connection between the biological fluid separation device 10 and the blood collection tube 130 during use of the biological fluid separation device 10 to separate plasma 16.

[0125] In one embodiment, the blood collection tube 130 includes a vent 134. The vent 134 allows air to be released, allowing the vacuum within the biological fluid separation device 10 to draw the blood sample 12 into the biological fluid separation device 10 and the plasma portion 16 through the separator 24 into the plasma chamber 36.

[0126] Once the desired amount of plasma 16 has been separated, the biological fluid separation device 10 is removed from the blood collection tube 130. Next, the separated plasma 16 is ready for distribution and / or analysis, as described in further detail below.

[0127] With the separated plasma 16 collected in the biological fluid separation device 10, the separated plasma 16 is ready to be distributed and / or analyzed. In one embodiment, the dispenser assembly 90 of the biological fluid separation device 10 can be used. For example, referring to Figure 1-4F In one embodiment, the inner housing 20 of the biological fluid separation device 10 includes a dispenser assembly or unit 90 that allows the plasma 16 contained within the plasma collection channel 48 to be discharged in a precise, controlled, and efficient manner.

[0128] refer to Figure 4C In such an embodiment, once plasma separation and collection are complete, the inner housing 20 is separated from the outer housing 22 ( Figure 4C In one embodiment, the inner housing 20 is separated from the outer housing 22 by removing the closure 60, which is still attached to the inner housing 20, from the outer housing 22. Removal of the closure 60 can be accomplished by a user grasping the outer shield 64 of the closure 60 and the outer housing 22 and pulling or twisting them in opposite directions.

[0129] Once the inner housing 20 is separated from the outer housing 22, the cap 80 can be removed from the inner housing 20, exposing the outlet 32 ​​of the inner housing 20. Removal can be accomplished by a user grasping an outer portion of the cap 80 and pulling the cap 80 away from the inner housing 20. In one embodiment, after the cap 80 is removed, the plasma 16 is retained within the plasma collection channel 48 of the inner housing 20 by capillary action.

[0130] refer to Figure 4D 、 4E, 11B and 12C, the plasma 16 can then be dispensed from the plasma collection channel 48 of the inner housing 20 by activating the dispenser assembly 90. As described above, in one embodiment, the inner housing 20 further includes a dispenser assembly 90 that allows the plasma 16 contained in the plasma collection channel 48 to be discharged in a precise, controlled and efficient manner. For example, referring to Figure 4C Once a sufficient amount of plasma 16 is collected in the plasma collection channel 48, the inner housing 20 can be removed from the outer housing 22. Next, the cap 80 is removed from the outlet 32, and the dispenser assembly 90 is used to dispense the plasma 16 from the plasma collection channel 48 of the inner housing 20.

[0131] refer to Figure 4D In one embodiment, the plasma 16 can be transferred to the sample container 110 while minimizing exposure of medical personnel to the plasma 16 of the blood sample 12 .

[0132] refer to Figure 4E In one embodiment, the plasma 16 can be transferred to a device for analyzing the plasma 16 , such as a point-of-care testing device 120 , a cartridge tester, or a near-patient testing device, while minimizing exposure of medical personnel to the plasma 16 of the blood sample 12 .

[0133] After the plasma 16 is separated, the separated plasma 16 is ready to be distributed and / or analyzed. In one embodiment, the plasma 16 may be separated using Figure 5-7D For example, referring to the embodiment of the biological fluid separation device 10 shown in FIG. Figure 5-7D In another embodiment, the plasma chamber outlet 46 of the inner housing 20 is in fluid communication with a portion of the interior 76 of the outer housing 22. In such an embodiment, reference is made to Figure 1-4F The dispensing assembly 90 of the inner housing 20 of the discussed embodiment is removed, and the plasma 16 is allowed to flow directly out of the plasma chamber outlet 46 into a portion of the interior 76 of the outer housing 22 .

[0134] refer to Figure 7B In such an embodiment, once plasma separation and collection are complete, the inner housing 20 is separated from the outer housing 22. Figure 7B , the discarded cellular portion 14 of the blood sample 12 remains within the inner housing 20 and can be disposed of after the plasma 16 is separated. Figure 7C and 7D The plasma 16 contained within the outer housing 22 may then be manually transferred or presented directly to a clinical analyzer.

[0135] In one embodiment, the separated plasma 16 fills the diagnostic assembly 200 for testing the plasma 16 for analytes immediately after separation without dispensing any plasma 16 from the biological fluid separation device 10. For example, referring to Figure 8-10D, the diagnostic assembly 200 provides an onboard diagnostic unit for testing the plasma 16 for analytes immediately after separation. The diagnostic assembly 200 will utilize, but is not limited to, optical testing and other methods. Possible applications include qualitative "yes or no" testing for the presence of an analyte, such as similar to a common pregnancy test, as well as quantitative results for analytes such as cholesterol or sodium. Reference Figure 10B In one embodiment, the onboard diagnostic component 200 can work alone. Figure 10D In one embodiment, the on-board diagnostic component 200 can interface with a test reader, such as a diagnostic adapter 208, such as a cell phone adapter, which connects the device 10 to a point-of-care diagnostic instrument 210, such as a cell phone camera, for imaging and analysis of sample results.

[0136] refer to Figure 13-17C In other embodiments, the blood chamber outlet 42 ( Figure 3E ) is in fluid communication with a portion of the interior 76 of the outer shell 22.

[0137] refer to Figures 17A-17C In one embodiment, during plasma separation, the device 10 directs the waste blood or cells 14 to the bottom of the interior 76 of the outer housing 22. The plasma 16 is collected in a dispenser unit or dispenser assembly 310 that is removably connected to a portion of the outer housing 22. Figure 17B In one embodiment, the dispenser unit 310 is removed along with the closure 60. The separation chip 58 and the discarded blood or cells 14 remain in the outer housing 22 and are discarded. Figure 17C In one embodiment, the plasma 16 may then be dispensed for testing using the dispenser unit 310 .

[0138] refer to Figure 13-16C In one embodiment, the device 10 includes a plasma collection channel 320 extending from the plasma chamber outlet 46 to a portion of the distributor unit 310. Figure 15-17C In one embodiment, the device 10 includes a plug 322 that is sized relative to the interior 76 of the outer housing 22 to provide a sealing engagement with the sidewall 74 of the outer housing 22. In one embodiment, the plug 322 divides the interior 76 of the outer housing 22 into a first sealed portion 324 and a second portion 326. In one embodiment, the blood chamber outlet 42 is in fluid communication with the first sealed portion 324 of the interior 76 of the outer housing 22.

[0139] Although the present disclosure is described as having an illustrative design, the present disclosure can be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to utilize its general principles to cover any variation, use or adaptation of the present disclosure. In addition, the present application is intended to cover the content that deviates from the present disclosure in the known or customary practice in the field related to the present disclosure, and these deviations fall within the scope of the appended claims.

Claims

1. A biological fluid separation device adapted to receive a blood sample having a first portion and a second portion, the biological fluid separation device comprising: a housing having an inlet and an outlet and a vent plug; a blood chamber having a blood chamber inlet and a blood chamber outlet, the blood chamber being adapted to receive the blood sample; a separation chamber having a chamber outlet; a separator disposed between the blood chamber and the separation chamber, the separator being adapted to retain the first portion in the blood chamber and allow the second portion to pass through the separator into the separation chamber; as well as an outer shell removably connectable to the housing, wherein the outer shell contains a first vacuum and the housing contains a second vacuum, wherein, in a case where the housing is connected to the outer housing, the housing is disposed within the outer housing, and wherein the first vacuum and the second vacuum are in communication via the vent plug; and A biological fluid separation device connector is removably connectable to a connector of a blood collection tube.

2. The biological fluid separation device according to claim 1, wherein: The first fraction is a cellular fraction and the second fraction is a plasma fraction.

3. The biological fluid separation device according to claim 2, wherein: The first vacuum and the second vacuum draw the blood sample within the housing and draw the plasma portion through the separator into the separation chamber.

4. The biological fluid separation device of claim 1, wherein: The separator includes a membrane surface having pores.

5. The biological fluid separation device of claim 1, wherein: The separator includes a track-etched membrane.

6. The biological fluid separation device of claim 1 , further comprising a closure covering an inlet of the housing, and in, The closure seals the open end of the housing with the housing connected to the outer housing.

7. The biological fluid separation device of claim 1, wherein: The inlet of the housing is located at a first end, and the outlet of the housing is located at an opposing second end. 8 . The biological fluid separation device of claim 1 , further comprising a plasma collection channel between the chamber outlet and an outlet of the housing.

9. The biological fluid separation device of claim 8, wherein: The plasma collection channel has a serpentine shape.

10. The biological fluid separation device of claim 1, further comprising a distributor assembly, the distributor assembly comprising: a cap covering the outlet and including the vent plug, the vent plug allowing air to pass therethrough and preventing the second portion of the blood sample from passing therethrough; as well as A deformable portion is transitionable between an initial position in which the second portion is contained within the separation chamber and a deformed position in which a portion of the second portion is expelled from the separation chamber.

11. The biological fluid separation device of claim 10, wherein: As the cap is removed from the outlet and the deformable portion transitions to the deformed position, a portion of the second portion is expelled from the biological fluid separation device.

12. The biological fluid separation device of claim 1 , further comprising a diagnostic component, the diagnostic component comprising: a diagnostic interface in communication with a chamber outlet of the separation chamber; as well as Sensor for testing the second part.

13. The biological fluid separation device of claim 1, wherein: With the biological fluid separation device connector connected to the blood collection tube, the vent of the blood collection tube allows the first vacuum and the second vacuum within the biological fluid separation device to pull the blood sample into the biological fluid separation device.

14. A biological fluid separation device adapted to receive a blood sample having a cellular portion and a plasma portion, the biological fluid separation device comprising: an inner housing having an inlet and an outlet; a blood chamber having a blood chamber inlet and a blood chamber outlet, wherein the blood chamber receives the blood sample; a plasma chamber having a plasma chamber outlet; a separator disposed between the blood chamber and the plasma chamber, the separator being adapted to retain the cell portion in the blood chamber and allow the plasma portion to pass through the separator into the plasma chamber; as well as an outer shell removably connectable to the inner shell, wherein the inner housing is disposed within the outer housing with the inner housing connected to the outer housing, and wherein a vacuum is defined by at least one of the inner housing and the outer housing to draw the plasma portion of the blood sample through the separator, and A biological fluid separation device connector is removably connectable to a connector of a blood collection tube.

15. The biological fluid separation device of claim 14, wherein: The outer shell includes an evacuation tube.

16. The biological fluid separation device of claim 14, wherein: With the biological fluid separation device connector connected to the blood collection tube, the vent of the blood collection tube allows a vacuum within the biological fluid separation device to pull the blood sample into the biological fluid separation device.

17. A biological fluid separation device adapted to receive a blood sample having a cellular portion and a plasma portion, the biological fluid separation device comprising: an outer shell having an open end, a closed end, and a sidewall extending between the open and closed ends and defining an interior; a dispenser unit removably connectable to the outer housing; An inner shell within the outer shell, the inner shell comprising: a blood chamber having a blood chamber inlet and a blood chamber outlet, the blood chamber receiving the blood sample, the blood chamber outlet being in fluid communication with a portion of the interior of the outer shell; a plasma chamber having a plasma chamber outlet; a separator disposed between the blood chamber and the plasma chamber, the separator being adapted to retain the cell portion in the blood chamber and allow the plasma portion to pass through the separator into the plasma chamber; and a plasma collection channel extending from the plasma chamber outlet into the distributor unit, and A biological fluid separation device connector is removably connectable to a connector of a blood collection tube. 18 . The biological fluid separation device of claim 17 , further comprising a plug sized relative to the interior of the outer housing to provide sealing engagement with a sidewall of the outer housing.

19. The biological fluid separation device of claim 18, wherein: The plug divides the interior of the outer shell into a first sealed portion and a second portion.

20. The biological fluid separation device of claim 17, wherein: In a condition where the dispenser unit is disconnected from the outer housing, the plasma portion is contained within the dispenser unit.

21. The biological fluid separation device of claim 17, wherein: With the biological fluid separation device connector connected to the blood collection tube, the vent of the blood collection tube allows a vacuum within the biological fluid separation device to pull the blood sample into the biological fluid separation device.

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