Patent Publication Number: US-2018049685-A1

Title: Biological Fluid Separation Device and Biological Fluid Separation and Testing System

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a divisional of U.S. application Ser. No. 14/251,699, filed Apr. 14, 2014, entitled “Biological Fluid Separation Device and Biological Fluid Separation and Testing System”, which claims priority to U.S. Provisional Application No. 61/811,918, filed Apr. 15, 2013, entitled “Medical Device for Collection of a Biological Sample”, the entire disclosures of each of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Disclosure 
     The present disclosure relates generally to devices, assemblies, and systems adapted for use with vascular access devices. More particularly, the present disclosure relates to devices, assemblies, and systems adapted for collecting biological samples for use in point-of-care testing. 
     2. Description of the Related Art 
     Blood sampling is a common health care procedure involving the withdrawal of at least a drop of blood from a patient. Blood samples are commonly taken from hospitalized, homecare, and emergency room patients either by finger stick, heel stick, or venipuncture. Blood samples may also be taken from patients by venous or arterial lines. Once collected, blood samples may be analyzed to obtain medically useful information including chemical composition, hematology, or coagulation, for example. 
     Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug effectiveness, and organ function. Blood tests may be performed in a clinical laboratory or at the point-of-care near the patient. One example of point-of-care blood testing is the routine testing of a patient&#39;s blood glucose levels which involves the extraction of blood via a finger stick and the mechanical collection of blood into a diagnostic cartridge. Thereafter, the diagnostic cartridge analyzes the blood sample and provides the clinician a reading of the patient&#39;s blood glucose level. Other devices are available which analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. Some other point-of-care devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE). 
     Despite the rapid advancement in point-of-care testing and diagnostics, blood sampling techniques have remained relatively unchanged. Blood samples are frequently drawn using hypodermic needles or vacuum tubes attached to a proximal end of a needle or a catheter assembly. In some instances, clinicians collect blood from a catheter assembly using a needle and syringe that is inserted into the catheter to withdraw blood from a patient through the inserted catheter. These procedures utilize needles and vacuum tubes as intermediate devices from which the collected blood sample is typically withdrawn prior to testing. These processes are thus device intensive, utilizing multiple devices in the process of obtaining, preparing, and testing blood samples. Each additional device increases the time and cost of the testing process. 
     Point-of-care testing devices allow for a blood sample to be tested without needing to send the blood sample to a lab for analysis. Thus, it is desirable to create a device that provides an easy, safe, reproducible, and accurate process with a point-of-care testing system. 
     SUMMARY OF THE INVENTION 
     The present disclosure provides a biological fluid separation device, such as a blood separation device, that is adapted to receive a multi-component blood sample, for example, having a cellular portion and a plasma portion. After collecting the blood sample, the blood separation device is able to separate the plasma portion from the cellular portion. After separation, the blood separation device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood separation device of the present disclosure also provides a closed separation system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer, which could be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. The blood separation device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood separation device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results. 
     Some of the advantages of the blood separation device and the biological fluid separation and testing system of the present disclosure over prior systems are that it is a closed system which reduces blood sample exposure, it provides passive and fast mixing of the blood sample with a sample stabilizer, it facilitates separation of the blood sample without transferring the blood sample to a separate device, and it is capable of transferring pure plasma to a point-of-care testing device. The blood separation device of the present disclosure enables integrated blood collection and plasma creation in a closed system without centrifugation. The clinician may collect and separate the blood sample and then immediately transfer the plasma portion to the point-of-care testing device without further manipulation. This enables collection and transfer of plasma to the point-of-care testing device without exposure to blood. In addition, the blood separation device of the present disclosure minimizes process time by processing the blood within the blood separation device and without external machinery. Further, for tests which only require small amounts of blood, it eliminates the waste associated with blood collection and plasma separation with an evacuated tube. 
     In accordance with an embodiment of the present invention, a biological fluid separation cartridge, such as a blood separation cartridge, includes a housing having an inlet port and a flow channel defined within the housing in fluid communication with the inlet port, a first collection chamber defined within the housing in fluid communication with the flow channel and including a first outlet port, and a second collection chamber defined within the housing in fluid communication with the flow channel and including a second outlet port. The second collection chamber is isolated from the first collection chamber, and the second outlet port is spaced apart from the first outlet port. 
     In certain configurations, the flow channel has a spiral shape. At least a portion of the flow channel may include a sample stabilizer. In certain arrangements, the cartridge may include an inlet channel in fluid communication with the inlet port and the flow channel, with the inlet channel including a sample stabilizer. The biological fluid separation cartridge may be adapted to receive a multi-component blood sample. The multi-component blood sample may include a cellular portion and a plasma portion. 
     The cartridge may include a flow channel having a separation element adapted to separate the cellular portion and the plasma portion of the multi-component blood sample. The separation element may include a plurality of posts. In certain configurations, the inlet port may be adapted to receive the multi-component blood sample via connection to a blood collection device. The first collection chamber may be adapted to receive at least a portion of the plasma portion therein, and the second collection chamber may be adapted to receive at least a portion of the cellular portion. In some cases, the cellular portion is prevented from entering the first collection chamber. The first outlet port may be adapted for connection to a point-of-care testing device for closed transfer of a portion of the plasma portion from the first collection chamber to the point-of-care testing device. In other configurations, a portion of the blood separation cartridge is adapted for connection with a drive device. When the drive device is connected to the blood separation cartridge, the drive device causes flow of the plasma portion from the first collection chamber to the point-of-care testing device. 
     In accordance with another embodiment of the present invention, a biological fluid separation device is adapted to receive a multi-component blood sample. The blood separation device includes a separation cartridge having an inlet port and a flow channel defined within the cartridge in fluid communication with the inlet port. The flow channel contains a separation element adapted to separate the multi-component blood sample into at least a first component and a second component. A first collection chamber defined within the cartridge in fluid communication with the flow channel includes a first outlet port, and a second collection chamber defined within the cartridge in fluid communication with the flow channel includes a second outlet port, with the second collection chamber isolated from the first collection chamber. 
     In certain configurations, the first component is a cellular portion of the multi-component blood sample and the second component is a plasma portion of the multi-component blood sample. The separation element may include a plurality of posts. In certain embodiments, the flow channel has a spiral shape. The inlet channel may be provided in fluid communication with the inlet port and the flow channel, with the inlet channel including a sample stabilizer. In certain embodiments, the second component is a plasma portion of the multi-component blood sample. 
     In specific arrangements, the first collection chamber is adapted to receive at least a portion of the second component therein and the second collection chamber is adapted to receive at least a portion of the first component. The first component may be a cellular portion of the multi-component blood sample and the second component may be a plasma portion of the multi-component blood sample. In certain embodiments, the cellular portion is prevented from entering the first collection chamber. Optionally, at least a portion of the flow channel includes a sample stabilizer. The second component may be a plasma portion of the multi-component blood sample. 
     In certain configurations, the inlet port is adapted to receive the multi-component blood sample via connection to a blood collection device. The first outlet port may be adapted for connection to a point-of-care testing device for closed transfer of a portion of the second component of the multi-component blood sample from the first collection chamber to the point-of-care testing device. A portion of the blood separation device may be adapted for connection with a drive device. When the drive device is connected to the blood separation device, the drive device causes flow of the second component of the multi-component blood sample from the first collection chamber to the point-of-care testing device. 
     In accordance with yet another embodiment of the present invention, a biological fluid separation and testing system, such as a blood separation and testing system, for a multi-component blood sample includes a blood separation cartridge adapted to receive the multi-component blood sample. The blood separation cartridge includes a housing having an inlet port and a flow channel defined within the housing in fluid communication with the inlet port. The cartridge further includes a first collection chamber defined within the housing in fluid communication with the flow channel and including a first outlet port, and a second collection chamber defined within the housing in fluid communication with the flow channel and including a second outlet port. The second collection chamber is isolated from the first collection chamber, and the second outlet port is spaced apart from the first outlet port. The system further includes a blood testing device having a receiving port adapted to receive the first outlet port of the blood separation cartridge for closed transfer of a portion of a component of the multi-component blood sample from the first collection chamber to the blood testing device. 
     In certain configurations, the multi-component blood sample includes a first cellular portion component and a second plasma portion component. A portion of the blood separation cartridge may be adapted for connection with a drive device. When the drive device is connected to the blood separation cartridge, the drive device causes flow of the plasma portion from the first collection chamber to the blood testing device. The blood testing device may include a point-of-care testing device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a perspective view of a biological fluid separation device in accordance with an embodiment of the present invention. 
         FIG. 2  is a top view of a biological fluid separation device in accordance with an embodiment of the present invention. 
         FIG. 3  is a perspective view of a biological fluid separation device in accordance with an embodiment of the present invention, with a first biological fluid collection device. 
         FIG. 4  is a perspective view of a biological fluid separation device in accordance with an embodiment of the present invention, with a second biological fluid collection device. 
         FIG. 5  is a cross-sectional, top view of a biological fluid separation cartridge in accordance with an embodiment of the present invention. 
         FIG. 6  is a detailed, fragmentary view of a portion of  FIG. 5 . 
         FIG. 7  is a perspective view of a biological fluid separation device and a point-of-care testing device in accordance with an embodiment of the present invention. 
         FIG. 8  is a cross-sectional view of a septum of a biological fluid separation device in accordance with an embodiment of the present invention, with the septum in a closed position. 
         FIG. 9  is a cross-sectional view of a septum of a biological fluid separation device in accordance with an embodiment of the present invention, with the septum in an open position. 
         FIG. 10  is a side elevation view of a biological fluid separation device in accordance with an embodiment of the present invention. 
         FIG. 11  is a side elevation view of a biological fluid separation device in accordance with an embodiment of the present invention, with a first component being removed from a second component. 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner. 
     DETAILED DESCRIPTION 
     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, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention. 
     For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. 
     Various point-of-care testing devices are known in the art. Such point-of-care testing devices include test strips, glass slides, diagnostic cartridges, or other testing devices for testing and analysis. Test strips, glass slides, and diagnostic cartridges are point-of-care testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states. There are many point-of-care devices that use cartridge based architecture to analyze very small amounts of blood bedside without the need to send the sample to a lab for analysis. This saves time in getting results over the long run but creates a different set of challenges versus the highly routine lab environment. Examples of such testing cartridges include the i-STAT® testing cartridge from the Abbot group of companies. Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician. 
     However, the samples provided to such point-of-care testing cartridges are currently manually collected with an open system and transferred to the point-of-care testing cartridge in a manual manner that often leads to inconsistent results, or failure of the cartridge leading to a repeat of the sample collection and testing process, thereby negating the advantage of the point-of-care testing device. Accordingly, a need exists for a system for collecting and transferring a sample to a point-of-care testing device that provides safer, reproducible, and more accurate results. Accordingly, a point-of-care collecting and transferring system of the present disclosure will be described hereinafter. A system of the present disclosure enhances the reliability of the point-of-care testing device by: 1) incorporating a more closed type of sampling and transfer system; 2) minimizing open exposure of the sample; 3) improving sample quality; 4) improving the overall ease of use; and 5) separating the sample at the point of collection. 
       FIGS. 1-11  illustrate an exemplary embodiment of the present disclosure. Referring to  FIGS. 1-11 , a biological fluid separation device, such as a blood separation device  10 , of the present disclosure is adapted to receive a blood sample  12  having a cellular portion  14  and a plasma portion  16 . After collecting the blood sample  12 , the blood separation device  10  is able to separate the plasma portion  16  from the cellular portion  14 . After separation, the blood separation device  10  is able to transfer the plasma portion  16  of the blood sample  12  to a point-of-care testing device. The blood separation device  10  of the present disclosure also provides a closed separation system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. 
       FIG. 7  illustrates an exemplary embodiment of the present disclosure. Referring to  FIG. 7 , a biological fluid separation and testing system, such as a blood separation and testing system  20  of the present disclosure, includes a blood separation device  10  and a blood testing device or point-of-care testing device  22  engageable with the blood separation device  10  for closed transfer of a portion of the plasma portion  16  ( FIG. 6 ) from the blood separation device  10  to the blood testing device  22 . The blood testing device  22  is adapted to receive the plasma portion  16  to analyze the blood sample and obtain test results. 
     Some of the advantages of the blood separation device and the blood separation and testing system of the present disclosure over prior systems are that it is a closed system which reduces blood sample exposure, it provides passive and fast mixing of the blood sample with a sample stabilizer, it facilitates separation of the blood sample without transferring the blood sample to a separate device, and it is capable of transferring pure plasma to a point-of-care testing device. The blood separation device of the present disclosure enables integrated blood collection and plasma creation in a closed system without centrifugation. The clinician may collect and separate the blood sample and then immediately transfer the plasma portion to the point-of-care testing device without further manipulation. This enables collection and transfer of plasma to the point-of-care testing device without exposure to blood. In addition, the blood separation device of the present disclosure minimizes process time by processing the blood within the blood separation device and without external machinery. Further, for tests which only require small amounts of blood, it eliminates the waste associated with blood collection and plasma separation with an evacuated tube. 
     Referring to  FIGS. 1-11 , a blood separation device  10  includes a first component or biological fluid separation cartridge, such as a blood separation cartridge  11  and a second component or drive device  13  that is removably connected to the blood separation cartridge  11 . The blood separation cartridge  11  is adapted to receive a blood sample  12  having a cellular portion  14  and a plasma portion  16 . In one embodiment, a blood separation cartridge  11  is a disposable component and connects with a reusable drive device  13  that is in the shape of a standard pipette which drives the flow of blood through the blood separation cartridge  11  and drives the flow of plasma into a point-of-care testing device  22 . 
     Referring to  FIGS. 1-11 , the blood separation cartridge  11  generally includes a housing  30 , an inlet port  32 , a flow channel  34  having an inlet channel  36  and an exit channel  38 , a first collection chamber  40  defined within the housing  30  and in fluid communication with the flow channel  34  and including a first outlet port  42 , a second collection chamber  44  defined within the housing  30  and in fluid communication with the flow channel  34  and including a second outlet port  46 , and a valve or septum  86  disposed at the first outlet port  42 . In one embodiment, the second collection chamber  44  is isolated from the first collection chamber  40  and the second outlet port  46  is spaced apart from the first outlet port  42 . Referring to  FIG. 6 , the flow channel  34  includes a separation element  50  that is adapted to separate the cellular portion  14  and the plasma portion  16  of the blood sample  12 . In one embodiment, the separation element  50  includes a plurality of posts  52 . The inlet channel  36  is in fluid communication with the inlet port  32 . 
     In one embodiment, the blood separation cartridge  11  is connectable with the drive device  13  to allow vacuum or pressure to drive flow of a blood sample within the blood separation cartridge  11 . The connection between the blood separation cartridge  11  and the drive device  13  does not allow blood contact with the drive device  13 . For example, the use of materials that only let air to pass, or one way valves, ensures that blood does not come in contact with the drive device  13 . 
     In one embodiment, the flow channel  34  has a spiral shape for inertial separation of blood cells, e.g., a cellular portion  14 , from a plasma portion  16  as shown in  FIG. 6 . In one embodiment, the flow channel  34  includes a plurality of posts  52  arranged to enhance plasma separation by filtering and directing the cellular portion  14  to the outside of the flow channel  34 , which is the same direction the inertial forces drive the cellular portion  14 . The posts  52  can be of any suitable shape, such as rounded, and may have a generally circular cross-section. In another configuration, the posts  52  may have any polygon shape, such as a polygon cross-sectional shape. 
     At the end of the flow channel  34 , e.g., a junction point  48 , the flow channel  34  splits into a first collection chamber  40  for collecting the plasma portion  16  and a second collection chamber  44  for collecting the cellular portion  14 . The first collection chamber  40  and the second collection chamber  44  includes no posts  52  to take advantage of laminar flow properties in a microfluidic channel. In one embodiment, to increase throughput, multiple spirals can be fabricated that operate in parallel to generate sufficient plasma volume for a downstream application. The first collection chamber  40  includes the first outlet port  42  which interfaces with a point-of-care testing device  22  or storage vessel as discussed in more detail below. The second outlet port  46  provides an outlet for the cellular portion  14  of the blood sample  12 . In one embodiment, the junction point  48  contains a mechanism for substantially preventing the cellular portion  14  from entering the first collection chamber  40 . For example, the junction point  48  may contain a filter or one-way valve or other mechanism. 
     In one embodiment, at least a portion of the flow channel  34  is adapted to contain a sample stabilizer to provide passive and fast mixing of a blood sample with the sample stabilizer. The sample stabilizer can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. In other embodiments, the sample stabilizer is provided in other areas of the housing  30  of the blood separation cartridge  11  such as the inlet channel  36 . In this manner, as a blood sample  12  flows through the inlet port  32  and into the flow channel  34 , the blood separation device  10  provides passive and fast mixing of the blood sample  12  with the sample stabilizer. 
     Referring to  FIGS. 1-4 , in one embodiment, the drive device  13  may comprise an electronic durable component that is in the shape of a standard pipette which drives the flow of blood through the blood separation cartridge  11  and drives the flow of plasma into a point-of-care testing device  22 . In one embodiment, the drive device  13  drives flow by vacuum or pressure and can actuate any required valves on the blood separation cartridge  11 . The drive device  13  can be battery operated or plugged into a wall outlet in some embodiments or, like some automated pipettes, use induction or plug-in charging with an internal rechargeable battery. In one embodiment, the drive device  13  may include an actuation member  60  and flow in or out is controlled by pressing the actuation member  60  on the top of the drive device  13  in a similar location to a plunger on a standard laboratory pipette. In other embodiment, the actuation member  60  or buttons may be located in a trigger position on the handle similar to automated serological pipettes. 
     The blood separation cartridge  11  and the drive device  13  are removably connectable theretogether such that significant relative movement between the blood separation cartridge  11  and the drive device  13  is prevented. Referring to  FIG. 11 , in one embodiment, the blood separation cartridge  11  and the drive device  13  are removably connectable theretogether via engagement of a first securement portion  47  of the blood separation cartridge  11  with a second securement portion  62  of the drive device  13 . In other embodiments, similar connection mechanisms may be used. For example, a snap fit engagement mechanism or a friction fit engagement mechanism may be used. With the blood separation cartridge  11  and the drive device  13  connected, the blood separation cartridge  11  is adapted to receive a blood sample  12  therein. In one embodiment, the inlet port  32  of the blood separation cartridge  11  is adapted to receive the blood sample upon actuation of the actuation member  60  of the drive device  13  as discussed in more detail below. 
     Referring to  FIGS. 3 and 4 , the inlet port  32  of the blood separation cartridge  11  is adapted to be connected to a blood collection set or blood collection device  100  to allow for the collection of a blood sample  12  into the blood separation device  10 . The inlet port  32  may be sized and adapted for engagement with a separate device, such as a needle assembly or IV connection assembly and, therefore, may include a mechanism for such engagement as is conventionally known. For example, in one embodiment, the inlet port  32  may include a luer lock or luer tip for engagement with an optional separate luer mating component of such a separate device for attachment therewith. For example, referring to  FIGS. 3 and 4 , the blood collection set  100  may include a luer component  102  for engagement with the inlet port  32  of the blood separation device  10 . In this manner, the inlet port  32  is connectable to the blood collection set  100  for the collection of a blood sample into the blood separation device  10 . In addition, a mechanism for locking engagement between the inlet port  32  and the blood collection set  100  may also be provided. Such luer connections and luer locking mechanisms are well known in the art. The blood collection set  100  may include a needle assembly, an IV connection assembly, a PICC line, an arterial indwelling line, or similar blood collection means. 
     The inlet port  32  may also include a resealable septum that is transitionable between a closed position and an open position. With the septum in an open position, a blood sample  12  may flow through the inlet port  32  to the flow channel  34  via the inlet channel  36 . 
     The blood separation cartridge  11  also may include a valve or septum  86  ( FIGS. 8 and 9 ) at the first outlet port  42 . The first outlet port  42  is adapted for connection to a point-of-care testing device  22  for closed transfer of a portion of the plasma portion  16  from the blood separation device  10  to the point-of-care testing device  22  via the first outlet port  42  as described in more detail below. The valve or septum  86  at the first outlet port  42  is transitionable between a closed position and an open position. With the valve or septum  86  in an open position ( FIG. 9 ), the plasma portion  16  of the blood sample  12  may flow through the first outlet port  42  to a blood testing device or a point-of-care testing device  22  ( FIG. 7 ). 
     Referring to  FIG. 7 , a blood testing device or point-of-care testing device  22  includes a receiving port  24  adapted to receive the first outlet port  42  of the blood separation device  10 . The blood testing device  22  is adapted to receive the first outlet port  42  of the blood separation device  10  for closed transfer of a portion of the plasma portion  16  ( FIG. 6 ) from the blood separation device  10  to the blood testing device  22 . The blood testing device  22  is adapted to receive the plasma portion  16  to analyze the blood sample and obtain test results. 
     As discussed above, the first outlet port  42  of the blood separation device  10  may include a valve or septum  86  that is transitionable between a closed position and an open position. With the valve or septum  86  in an open position ( FIG. 9 ), the plasma portion  16  of the blood sample  12  may flow through the first outlet port  42  to a blood testing device or a point-of-care testing device  22  ( FIG. 7 ). 
     In one embodiment, referring to  FIGS. 8 and 9 , the valve  86  may generally include a transfer channel  90 , a bellows or deformable wall member  92 , and a septum or barrier  94  having a first barrier wall  96  and a second barrier wall  98 . Referring to  FIG. 8 , the valve  86  is in a closed position to prevent the plasma portion  16  of the blood sample  12  from flowing through the first outlet port  42 . In this manner, the plasma portion  16  is sealed within the blood separation device  10 . Referring to  FIG. 9 , the valve  86  is in an open position so that the plasma portion  16  of the blood sample  12  may flow through the first outlet port  42  to a blood testing device or a point-of-care testing device  22  ( FIG. 7 ). 
     Referring to  FIG. 9 , with the plasma portion  16  received within the first outlet port  42  of the blood separation device  10 , the first outlet port  42  of the blood separation device  10  is then positioned over the receiving port  24  of the point-of-care testing device  22 . Pushing down in the direction of arrow B compresses the deformable wall member  92  and opens up the first barrier wall  96  and the second barrier wall  98  of the septum  94  as shown in  FIG. 9 . With the valve  86  in the open position, the plasma portion  16  of the blood sample  12  is allowed to flow through the first outlet port  42  and the receiving port  24  to the point-of-care testing device  22  in a closed manner, reducing exposure to the clinician and the patient. 
     The valve  86  of the blood separation device  10  only opens when the first outlet port  42  is pressed upon the receiving port  24  of the point-of-care testing device  22 . This releases the isolated plasma portion  16  directly into the receiving port  24  of the point-of-care testing device  22 , thus mitigating unnecessary exposure to the patient&#39;s blood. 
     Referring to  FIGS. 10 and 11 , a blood separation system of the present disclosure will now be discussed. In one embodiment, the drive device  13  is connectable with any number of blood separation cartridges  11 . In this manner, a blood separation cartridge  11  is a replaceable single use component. As will be described below, after use of a blood separation cartridge  11 , the blood separation cartridge  11  can be removed from the drive device  13 , as shown in  FIG. 11 , and the blood separation cartridge  11  can be disposed of into a biological hazard container. When it is desired to use the blood separation device  10  again, a new and clean blood separation cartridge  11  can be selected and used with the drive device  13 . One advantage of the blood separation system of the present disclosure is that a plurality of blood separation cartridges  11  can be used with the drive device  13 . The drive device  13  can be repeatedly used. 
     Referring to  FIGS. 1-11 , use of a blood separation device and blood separation and testing system of the present disclosure will now be described. Referring to  FIGS. 3 and 4 , the inlet port  32  of the blood separation device  10  is adapted to be connected to a blood collection set  100  to allow for the collection of a blood sample  12  into the blood separation device  10  as discussed above. Once the blood collection set  100  is connected to a patient, the actuation member  60  of the drive device  13  is activated, e.g., a power switch is pushed down, to draw the blood sample into the flow channel  34  of the blood separation cartridge  11 . As the blood sample  12  slowly fills the blood separation device  10 , it is collected and stabilized over a layer of sample stabilizer. Referring to  FIG. 6 , the blood sample  12  may then flow through the flow channel  34  for inertial separation of the cellular portion  14  from the plasma portion  16 . Inside of the flow channel  34 , the series of posts  52  are arranged to enhance plasma separation by filtering and directing the cellular portion  14  to the outside of the flow channel  34 , which is the same direction that the inertial forces drive the cellular portion  14 . 
     At the end of the flow channel  34 , e.g., the junction point  48 , the flow channel  34  splits into a first collection chamber  40  for collecting the plasma portion  16  and a second collection chamber  44  for collecting the cellular portion  14 . The first collection chamber  40  and the second collection chamber  44  include no posts  52  to take advantage of laminar flow properties in a microfluidic channel. In one embodiment, to increase throughput, multiple spirals can be fabricated that operate in parallel to generate sufficient plasma volume for a downstream application. The first collection chamber  40  includes the first outlet port  42  which interfaces with a point-of-care testing device  22  or storage vessel. 
     After disconnecting the blood separation device  10  from the blood collection set  100  or other blood collection line, the blood separation device  10  may be engaged with a blood testing device  22 . Next, the first outlet port  42  is placed over the receiving port  24  of the point-of-care testing device  22  as shown in  FIG. 7 . Then, the actuation member  60  of the drive device  13  may be activated or depressed to advance the plasma portion  16  and to transfer the collected plasma portion  16  to the point-of-care testing device  22 . The blood testing device  22  is adapted to receive the first outlet port  42  of the blood separation device  10  for closed transfer of a portion of the plasma portion  16  from the blood separation device  10  to the blood testing device  22 . The blood testing device  22  is adapted to receive the plasma portion  16  to analyze the blood sample and obtain test results. After that, the blood separation cartridge  11  can be removed from the drive device  13 , as shown in  FIG. 11 , and the blood separation cartridge  11  can be disposed of into a biological hazard container. 
     Current systems for blood collection use centrifugation of blood collection tubes often in a centralized lab to generate plasma. This limits the ability to use plasma for point-of-care testing. The blood separation system of the present disclosure relies on inertial forces and a gentler filtration to generate plasma. The filtration posts are made of the same material as the device so analyte bias and passivation is the same for the posts as the parent device. By using the two methods to drive the cellular portion into a separate flow stream, less filtration should be required to generate the same quality plasma. 
     Some of the other advantages of the blood separation device and the blood separation and testing system of the present disclosure over prior systems are that it is a closed system which reduces blood sample exposure, it provides passive and fast mixing of the blood sample with a sample stabilizer, it facilitates separation of the blood sample without transferring the blood sample to a separate device, and it is capable of transferring pure plasma to the point-of-care testing device  22 . The blood separation device of the present disclosure enables integrated blood collection and plasma creation in a closed system without centrifugation. The clinician may collect and separate the blood sample and then immediately transfer the plasma portion to the point-of-care testing device  22  without further manipulation. This enables collection and transfer of plasma to the point-of-care testing device  22  without exposure to blood. In addition, the blood separation device of the present disclosure minimizes process time by processing the blood within the blood separation device and without external machinery. Further, for tests which only require small amounts of blood, it eliminates the waste associated with blood collection and plasma separation with an evacuated tube. 
     While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this 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 present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.