Adapter for sample collection and methods of using the same
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Filing Date
- 2024-07-26
- Publication Date
- 2026-06-10
AI Technical Summary
Current methods for blood sample collection face challenges in accurately detecting hemolysis, which can lead to inaccurate test results and require additional processing steps like centrifugation, increasing complexity and time delays.
An adapter for blood draw that includes a vacuum channel and a viewing region, allowing for the redirection and separation of a blood sample portion during collection. This adapter enables visual inspection for hemolysis without further processing, using the vacuum from a vacuum-sealed sample container to draw blood into the adapter.
The adapter allows for efficient hemolysis detection during or after blood draw, reducing the need for additional processing steps and minimizing delays in sample testing, while maintaining accurate results.
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Figure US2024039723_06022025_PF_FP_ABST
Abstract
Description
ADAPTER FOR SAMPLE COLLECTION AND METHODS OF USING THE SAME
[0001] Thisapplication claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 516,977, filed August 1, 2023. The entire contents of the above-referenced patent application are hereby expressly incorporated herein by reference. FIELD
[0002] The present application relates to biological sample collection, and more particularly to an adapter for use during sample collection and methods for using the same. BACKGROUND
[0003] Blood samples are typically collected in cylindrical sample containers (e.g., sample tubes). Once collected, blood samples or components of blood samples, such as blood serum or blood plasma, may be analyzed (e.g., to determine red or white blood cell counts, AST, ALT, PT, potassium, magnesium, albumin, amylase, bilirubin, calcium, cholesterol, alkaline phosphate, alanine aminotransferase, cardiac troponin I, or cardiac troponin levels, etc.).
[0004] Red blood cells in a blood sample can break down and release hemoglobin into surrounding fluid (referred to as hemolysis). The presence of hemoglobin in blood serum or blood plasma can lead to inaccurate test results, such as elevated AST, ALT, PT, potassium, magnesium, albumin, amylase, bilirubin, calcium, cholesterol, alkaline phosphate, alanine aminotransferase, cardiac troponin I, or cardiac troponin levels. For this reason, blood samples are typically checked for hemolysis prior to testing, and samples with elevated hemolysis levels may be discarded.
[0005] Determining hemolysis levels from whole blood isdifficult because of the presence of red blood cells. For this reason, red blood cells are removed, such as by centrifugation, prior to hemolysis inspection. Such a step adds complexity and time delays to sample testing. As such, improved apparatus and methods for detecting hemolysis are desired. SUMMARY
[0006] In some embodiments, an adapter for use during a blood draw is provided that includes an adapter body having a sidewall, an end surface, a vacuum channel, and a viewing region that allows viewing of the vacuum channel of the adapter body. The adapter includes a needle having a first end and a second end, wherein the first end of the needle has an opening into the vacuum channel of the adapter body and the second end of the needle extends from the adapter body wherein, when the adapter body is placed over and pressed against a cap of a vacuum-sealed sample container, the needle is configured to pierce the cap of the vacuum-sealed sample container and create a vacuum within the vacuum channel of the adapter body.
[0007] In some embodiments, a sample container sealing unit for use with a vacuum-sealed sample container is provided that includes a cap configured to seal an end of a vacuum-sealed sample container and an adapter body coupled to the cap. The adapter body has a vacuum channel and a viewing region that allows viewing of the vacuum channel of the adapter body. The sample container sealing unit includes a pass through having a first end and a second end, wherein the first end of the pass through has an opening into the vacuum channel of the adapter body and the second end of the pass through extends through the cap so that, when the cap seals the vacuum-sealed sample container, both the vacuum-sealed sample container and the vacuum channel of the adapter body are under vacuum.
[0008] In some embodiments, a method of determining a property of a blood sample is provided. The method includes receiving a blood draw adapter that includes an adapter body having a sidewall, an end surface, a vacuum channel and a viewing region that allows viewing of the vacuum channel. The blood draw adapter includes a needle having a first end that opens into the vacuum channel and a second end that extends from the adapter body. The method also includes employing the needle of the blood draw adapter to pierce a cap of a vacuum- sealed sample container so as to create a vacuum within the vacuum channel through the needle based on a vacuum within the vacuum-sealed sample container. The method further includes employing the vacuum of the vacuum-sealed sample container to draw blood into the vacuum-sealed sample container and employing the vacuum of the vacuum channel of the blood draw adapter to draw blood from the vacuum-sealed sample container into the vacuum channel of the blood draw adapter. The method further includes viewing the blood in the vacuum channel through the viewing region of the blood draw adapter and identifying a property of the blood in the vacuum channel based on the viewing.
[0009] In some embodiments, another method of determining a property of a blood sample is provided. The method includes receiving a vacuum-sealed sample container system having a vacuum-sealed sample container sealed with a cap; and an adapter coupled to the cap, the adapter having a vacuum channel, a viewing region that allows viewing of the vacuum channel, and a pass through that extends from the vacuum channel through the cap so that both the vacuum-sealed sample container and the vacuum channel of the adapter are under a vacuum. The method also includes employing the vacuum of the vacuum-sealed sample container to draw blood into the vacuum- sealed sample container and employing the vacuum of the vacuum channel of the adapter to draw blood from the vacuum-sealedsample container into the vacuum channel of the adapter. The method further includes viewing the blood in the vacuum channel through the viewing region of the adapter and identifying a property of the blood in the vacuum channel based on the viewing.
[0010] Other features and aspects of the present invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1A is a side view of an example hemolysis detection system in accordance with embodiments provided herein.
[0012] FIG. 1B is a side view of the hemolysis detection system of FIG. 1A wherein the adapter is assembled in accordance with embodiments provided herein.
[0013] FIG. 1C is a side view of the adapter of FIG. 1A coupled to a cap of a vacuum-sealed sample container in accordance with embodiments provided herein.
[0014] FIG. 1D is a side view of the adapter of FIG. 1A coupled to a cap of a vacuum-sealed sample container and having a blood draw needle inserted therethrough in accordance with embodiments provided herein.
[0015] FIG. 2A illustrates a side perspective view of an example embodiment of the adapter of FIGS. 1A-1D in accordance with embodiments provided herein.
[0016] FIG. 2B illustrates a top view of an example embodiment of the adapter of FIG. 2A with a cover and needle removed in accordance with embodiments provided herein.
[0017] FIG. 2C illustrates a side view of the adapter of FIG. 2A wherein the needle is coupled to the cover in accordance with embodiments provided herein.
[0018] FIG. 2D illustrates a side view of the adapter ofFIG. 2A wherein the needle terminates at the vacuum channel in accordance with embodiments provided herein.
[0019] FIG. 3A-3C illustrate an exploded side view, an assembled side view, and a side perspective view, respectively, of an alternative embodiment of an adapter in which a vacuum channel is located in a sidewall of the adapter in accordance with embodiments provided herein.
[0020] FIGS. 4A-4B illustrate an unassembled side view and a side view, respectively, of a first sample container sealing unit in accordance with embodiments provided herein.
[0021] FIG. 4C illustrates a first vacuum-sealed sample container system formed by using the first sample container sealing unit of FIGS. 4A-4B to seal a vacuum-sealed sample container in accordance with embodiments provided herein.
[0022] FIGS. 4D-4E illustrate an unassembled side view and a side view, respectively, of a second sample container sealing unit in accordance with embodiments provided herein.
[0023] FIG. 4F illustrates a second vacuum-sealed sample container system formed by using the second sample container sealing unit of FIGS. 4D-4E to seal a vacuum-sealed sample container in accordance with embodiments provided herein.
[0024] FIG. 4G illustrates a side view of a third sample container sealing unit in accordance with embodiments provided herein.
[0025] FIG. 4H illustrates a third vacuum-sealed sample container system formed by using the third sample container sealing unit of FIG. 4G to seal a vacuum-sealed sample container in accordance with embodiments provided herein.
[0026] FIG. 5 illustrates a flowchart of a method of determining a property of a blood sample in accordance with embodiments provided herein.
[0027] FIG. 6 is a side view illustrating the collection of a blood sample from a patient arm using a blood draw needle, vacuum-sealed sample container, and adapter in accordance withembodiments provided herein.
[0028] FIG. 7 illustrates a flowchart of another method of determining a property of a blood sample in accordance with embodiments provided herein. DETAILED DESCRIPTION
[0029] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.
[0030] As described above, hemolysis may lead to inaccurate blood sample results. However, hemolysis inspection may add delays to sample testing. In accordance with embodiments provided herein, an adapter for use with a sample container during a blood draw is provided that advantageously allows for hemolysis testing during the blood draw. That is, in some embodiments, an adapter may be provided that redirects a small portion of a blood sample (during a blood draw) and separates red blood cells from the redirected portion so that a visual inspection for hemolysis may be performed during and / or after the blood draw. Hemolysis detection may be performed with no further processing of the blood sample, such as centrifugation, reducing test time and complexity. Significantly, no additional steps or external equipment are employed for hemolysis detection after a blood draw (other than visual inspection by a medical technician).
[0031] Vacuum-sealed sample containers, such as Vacutainer® tubes available from Becton Dickson of Franklin Lakes, NJ or VACUETTE® tubes available from Greiner Bio-One of Monroe, NC, are evacuated to a predetermined vacuum level and sealed with a color-coded cap that identifies the type of preservatives, anti-coagulants, or other additives contained within the vacuum-sealed sample containers. The vacuum level of a vacuum- sealed sample container is employed to control how much blood is collected by the sample container during sample collection.
[0032] In one or more embodiments provided herein, the vacuum present in a vacuum-sealed sample container may be employed to draw a portion of a blood sample into an adapter for hemolysis detection. Accordingly, instead of employing capillary action for blood sample movement from the vacuum- sealed sample container to the adaptor, embodiments of the present invention advantageously employ the vacuum present in a vacuum-sealed sample container to draw the blood sample into the adaptor. For example, in some embodiments, an adapter includes an adapter body having a sidewall and an end surface. The end surface and / or the sidewall may include a vacuum channel and a viewing region that allows viewing of the vacuum channel through the adapter body. The adapter includes a needle with a first end that opens into the vacuum channel of the adapter body and the second end that extends from the adapter body. When the adapter body is placed over and pressed against a cap of a vacuum-sealed sample container, the needle pierces the cap of the vacuum-sealed sample container and creates a vacuum within the vacuum channel of the adapter body. That is, the vacuum channel of the adapter is in fluid communication with the interior of the vacuum-sealed sample container and the pressure within the vacuum channel of the adapter equilibrates with the pressure within the vacuum- sealed sample container resulting in a vacuum or reduced pressure in the vacuum channel of the adapter. This allows blood drawn into the vacuum-sealed sample container during a blood draw to also be drawn into the vacuum channel of the adapter. That is, during blood draw from a patient, as a result of the blood sample being drawn into the vacuum-sealed sample container from a patient, the vacuum in the vacuum- sealed sample container dissipates; that is the pressure in the vacuum-sealed sample container increases. As a result of the increased pressure in the vacuum-sealed sample container, the blood sample in the vacuum-sealed sample container isdrawn to the vacuum channel of the adapter until the pressures between the vacuum channel of the adapter and the vacuum- sealed sample container equilibrate. In other words, the pressure differential between the vacuum-sealed sample container and the adaptor causes the blood sample to flow from the container to the adaptor until the pressure differential dissipates (i.e., the container and adaptor pressures equilibrate).
[0033] The vacuum channel of the adapter may include a filter mechanism that separates one or more components from a blood sample as it is drawn into the vacuum channel. For example, for hemolysis detection, the filter mechanism may be configured to filter red blood cells from the blood sample. Example filter mechanisms include an asymmetric membrane, cellulose, cellulose coated with lectin, an anti-human red blood cell antibody-coated membrane, a porous hydrophilic membrane, a hydrophobic membrane, a polymer or glass fiber, or the like.
[0034] Once the adapter is coupled to a vacuum-sealed sample container, a blood draw needle may be inserted through the adapter (e.g., via a passage within the adapter as described below) and through the cap of the vacuum-sealed sample container. The other end of the blood draw needle is inserted into the patient from which a blood sample is to be obtained. The vacuum within the vacuum-sealed sample container draws blood from the patient into the vacuum-sealed sample container and the vacuum within the vacuum channel of the adapter draws blood into the vacuum channel. During the blood draw, or after the blood draw, a medical technician may view the vacuum channel to detect hemolysis through the viewing region of the adapter.
[0035] These and other embodiments are described below with reference to FIGS. 1A-7.
[0036] FIG. 1A is a side view of an example hemolysisdetection system 100 in accordance with embodiments provided herein. While described with regard to hemolysis detection, it will be understood that the adapters described herein may be employed to detect other properties and / or conditions.
[0037] With reference to FIG. 1A, hemolysis detection system 100 includes a vacuum-sealable sample container 102 that may be sealed with a cap 104. Any suitable vacuum-sealed sample container may be employed, such as a Vacutainer® tube available from Becton Dickson of Franklin Lakes, NJ or a VACUETTE® tube available from Greiner Bio-One of Monroe, NC. Vacuum-sealed sample container 102 may be evacuated to a predetermined vacuum level (within an interior region 106) and sealed with cap 104. Cap 104 may be color-coded to identify the type of preservatives, anti-coagulants, or other additives contained within the vacuum-sealed sample container 102. The vacuum level of the vacuum-sealed sample container 102 may be employed to control how much blood is collected by the vacuum- sealed sample container 102 during sample collection.
[0038] Hemolysis detection system 100 further includes an adapter 108. Adapter 108 includes an adapter body 110 having a sidewall 112 and an end surface 114. In the embodiment of FIG. 1A, the sidewall 112 and end surface 114 form a cavity 116 sized to fit over the cap 104 of the vacuum-sealed sample container 102. In some embodiments, the use of a cylindrical sidewall to fit over the cap 104 may be eliminated (although the sidewall 112 provides protection against a needle employed with the adapter 108 as described below). Other adapter body shapes may be used (e.g., elliptical or polygonal).
[0039] The adapter body 110 includes a vacuum channel 118, which in the embodiment of FIG. 1A is located in the end surface 114 of adapter body 110. In other embodiments, described below with reference to FIGS. 3A-3C, the vacuum channel 118 may be located in sidewall 112. In some embodiments, the vacuum channel 118 may have a width of about1 / 16 to 1 / 8 of an inch, a depth of about 1 / 64 to 1 / 32 of an inch, and a length of about 0.26 to 1.61 inches. Other vacuum channel dimensions may be employed.
[0040] Adapter 108 includes a cover 120 sized to cover and enclose the vacuum channel 118. In the embodiment of FIG. 1A, the cover 120 includes a viewing region 122 that allows viewing of the vacuum channel 118 of the adapter body 108. For example, the cover 120 may be formed from a clear material such as a clear plastic, glass, or the like. Adapter 108 also includes a needle 124 having a first end 126a and a second end 126b.
[0041] FIG. 1B is a side view of the hemolysis detection system 100 of FIG. 1A wherein the adapter 108 is assembled in accordance with embodiments provided herein. As shown in FIG. 1B, the first end 126a of the needle 124 has an opening 128 (see also FIG. 2C) into the vacuum channel 118 of the adapter body 110 and the second end 126b of the needle 124 extends into the cavity 116 of the adapter body 110. When the adapter body 110 is placed over and pressed against the cap 104 of the vacuum-sealed sample container 102, the needle 124 (e.g., the second end 126b) pierces the cap 104 of the vacuum-sealed sample container 102 and creates a vacuum within the vacuum channel 118 of the adapter body 110 (as shown in FIG. 1C).
[0042] Any suitable needle size may be employed for the needle 124. In some embodiments, the needle may be formed from stainless steel having a hole size of about 20-22 gauge. Example needle lengths range from about 0.3 to 0.6 inches. Other needle sizes, shapes and / or materials may be employed. For example, a square or u-shaped (e.g., non-solid sidewall) needle may be used.
[0043] Once the adapter 108 is coupled to the vacuum-sealed sample container 102 via insertion of the needle 124 of the adapter 108 through the cap 104, a blood draw needle 130 (having a shield 132) may be inserted into a vein of a patientvia a first end 134a of the blood draw needle 130. A second end 134b of the blood draw needle may be inserted through the adapter 108 (e.g., via a passage within the adapter 108 as described below) and through the cap 104 of the vacuum-sealed sample container 102. The vacuum within the vacuum-sealed sample container 102 draws blood from the patient into the vacuum-sealed sample container 102 and the vacuum within the vacuum channel 118 of the adapter 108 draws blood into the vacuum channel 118. That is, the lower pressure in the vacuum- sealed sample container 102 relative to the external environment outside the container 102 draws blood from the patient into the vacuum-sealed sample container 102. As the vacuum-sealed sample container 102 fills with the blood sample, the container vacuum dissipates and the pressure within the container 102 increases. The increased container pressure causes a pressure differential between the vacuum- sealed sample container 102 and vacuum channel 118 of the adaptor 108, thus the lower pressure (or vacuum) within the vacuum channel 118 draws the blood sample from container 102 into the vacuum channel 118.
[0044] While the adapter body 110 and cover 120 are shown as round in FIGS. 1A-1D, other shapes may be employed (e.g., square, triangular, other polygonal shapes, etc.). The adapter body 110 and / or cover 120 may be formed from a polymer or a plastic such as polyurethane, polycarbonate, polyacrylate, polystyrene, etc. Other adapter body and / or cover materials may be employed. For example, in some embodiments, both the adapter body 110 and cover 120 may be formed from the same material (e.g., a clear plastic). In other embodiments, the adapter body 110 and cover 120 may be formed from different materials and / or only the cover 120 (or the viewing region 122 of the cover 120) may be transparent.
[0045] FIG. 2A illustrates a side perspective view of an example embodiment of the adapter 108 of FIGS. 1A-1D providedherein. FIG. 2B illustrates a top view of the adapter 108 of FIG. 2A with the cover 120 and needle 124 removed. FIG. 2C illustrates a side view of the adapter 108 wherein the needle 124 is coupled to the cover 120, while FIG. 2D illustrates a side view of the adapter 108 wherein the needle 124 terminates at the vacuum channel 118.
[0046] With reference to FIGS. 2A and 2B, the vacuum channel 118 is shown as a circular channel (e.g., extending about ¾ of the way around the end surface 114). The vacuum channel 118 may extend further or less far around the end surface 114. In the embodiment shown, the vacuum channel 118 of the adapter body 110 includes an opening 202 (FIG. 2B) that extends into the cavity 116 (FIGS. 1A-1D) of the adapter body 110. In such cases, as shown in FIG. 2A, the needle 124 may be inserted through adapter body 110 into the cavity 116 (FIGS. 1A-1D) through the opening 202.
[0047] The vacuum channel 118 of the adapter body 110 may include a filter mechanism 204 configured to separate at least one component from a blood sample that travels through the needle 124 into the vacuum channel 118. For example, for hemolysis detection, the filter mechanism 204 may be configured to filter red blood cells from a blood sample. In one or more embodiments, materials of the filter mechanism 204 may be selected that capture red blood cells and allow blood plasma, blood serum, and free hemoglobin to pass.
[0048] Example filter mechanisms include an asymmetric membrane (such as an asymmetric polysulfone material), cellulose, cellulose coated with lectin, an anti-human red blood cell antibody-coated membrane, a porous hydrophilic membrane, a hydrophobic membrane, a polymer or glass fiber, or the like. In some embodiments, the filter mechanism 204 may extend about 0.26 to about 1.6 inches into the vacuum channel 118 and fill the vacuum channel 118 over this length. Other filter mechanism lengths and / or locations may be employed. Forexample, the filter mechanism 204 may include a pre-filter material such as a glass fiber followed by an asymmetric filter. In some embodiments, varying pore size materials may be employed that decrease in pore size as a blood sample travels through the vacuum channel 118.
[0049] In one or more embodiments, the vacuum channel 118 may include a colorimetric reagent 206 that changes color in response to a component within a blood sample within the vacuum channel 118 of the adapter body 110. For example, the colorimetric reagent 206 may change color in response to hemoglobin. Example colorimetric reagents include diisopropylbenzene dihydroperoxide, 3, 3’, 5, 5’- tetramethylbenzidine. Other colorimetric reagents may be employed. Use of a colorimetric reagent 206 facilitates identification of hemolysis or other properties through a color change viewable via the viewing region 122 of the cover 120.
[0050] To assist in hemolysis detection, in some embodiments, the cover 120 and / or viewing region 122 may include one or more reference colors (e.g., white and varying shades of pink indicative of different levels / concentrations of hemolysis) against which a medical technician may compare a blood sample within the vacuum channel 118. That is, a medical technician may quickly determine an estimated hemolysis level by matching the color of the blood sample within the vacuum channel 118 (as seen through the cover 120) with a reference color having a known hemolysis level (e.g., concentration).
[0051] With reference to FIGS. 2A and 2B, the cover 120 may include a first passage 208 and the adapter body 110 may include a second passage 210 that align so as to allow a blood draw needle (e.g., needle 130 of FIG. 1D) to pass through the adapter 108. In some embodiments, the first and second passages 208 and 210 are sized to allow a butterfly blood-draw needle (not shown) to pass through the adapter 108. Otherpassage locations, shapes and / or sizes may be employed.
[0052] As shown in FIG. 2C, in some embodiments, the first end 126a of the needle 124 may be coupled to the cover 120. In such embodiments, a portion of the sidewall of needle 124 at the first end 126a may be removed so that the passageway created by the needle 124 allows blood to flow through the needle 124 into the vacuum channel 118 of the adapter 108. In other embodiments, such as shown in FIG. 2D, the first end 126a of the needle 124 may terminate at or below the vacuum channel 118 (so that the first end 126a of the needle serves as the opening 128 into the vacuum channel 118). Other configurations may be employed for the needle 124.
[0053] FIG. 3A-3C illustrate an exploded side view, an assembled side view, and a side perspective view, respectively, of an alternative embodiment of the adapter 108 provided herein in which the vacuum channel 118 is located in the sidewall 112 of the adapter 108. With reference to FIGS. 3A-3C, the adapter 108 may be formed from an inner adapter ring 302 that slides within an outer adapter ring 304 to form vacuum channel 118. Needle 124 may extend through the nested inner and outer adapter rings 302, 304 so that a first end 126a of needle 124 is in fluid communication with the vacuum channel 118 and a second end 126b of the needle 124 extends from the adapter 108 (for use in piercing the cap 104 of the vacuum-sealed sample container 102 prior to a blood draw). As with the adapter 108 embodiments of FIGS. 1A-2D, the vacuum channel 118 may include a filter mechanism (not separately shown) for removing one or more components of a blood sample as the blood sample enters the vacuum channel 118 and / or a colorimetric reagent (not shown) that reacts with a blood sample within the vacuum channel 118 and changes color to indicate a property and / or chemical component of the blood sample.
[0054] As shown in FIG. 3B, the outer ring 304 may includea viewing region 122 through which vacuum channel 118 may be seen. For example, in some embodiments, outer adapter ring 304 may be formed from a clear plastic, glass, or similar material that allows observation of the vacuum channel 118 (and any blood sample therein) through the sidewall 112 of the outer adapter ring 304). In other embodiments, a separate viewing window 122 may be formed within the outer adapter ring 304. Other sidewall vacuum channel configurations may be employed. To assist in hemolysis detection, in some embodiments, the sidewall 112 and / or viewing region 122 may include one or more reference colors as described previously.
[0055] FIGS. 4A-4B illustrate an unassembled side view and a side view, respectively, of a first sample container sealing unit 400a in accordance with embodiments provided herein. With reference to FIGS. 4A-4B, the first sample container sealing unit 400a includes the adapter 108 of FIGS. 1A-2D and the cap 104. In FIG. 4B, the needle 124 extends through cap 104 to form the first sample container sealing unit 400a, which may be used to seal a vacuum-sealed sample container (e.g., vacuum-sealed sample container 102). For the first sample container sealing unit 400a, viewing of the vacuum channel 118 for hemolysis detection may be performed through the cover 120. FIG. 4C illustrates a first vacuum-sealed sample container system 402a formed by using the first sample container sealing unit 400a to seal the vacuum-sealed sample container 102. Note that the vacuum level within the vacuum channel 118 and the vacuum-sealed sample container 102 may be equal.
[0056] Likewise, FIGS. 4D-4E illustrate an unassembled side view and a side view, respectively, of a second sample container sealing unit 400b in accordance with embodiments provided herein. With reference to FIGS. 4D-4E, the second sample container sealing unit 400b includes the adapter 108 of FIGS. 3A-3C and the cap 104. In FIG. 4E, the needle 124extends through cap 104 to form the second sample container sealing unit 400b, which may be used to seal a vacuum-sealed sample container (e.g., vacuum-sealed sample container 102). For the second sample container sealing unit 400b, viewing of the vacuum channel 118 for hemolysis detection may be performed through the sidewall 112. FIG. 4F illustrates a second vacuum-sealed sample container system 402b formed by using the second sample container sealing unit 400b to seal the vacuum-sealed sample container 102. Note that the vacuum level within the vacuum channel 118 and the vacuum-sealed sample container 102 may be equal.
[0057] An advantage of the first sample container sealing unit 400a (FIG. 4B) includes ease of manufacture. Additionally, prior to coupling the adapter 108 to the cap 104, the needle 124 is contained within the cavity 116 of the adapter 108. This provides additional protection to the person who will couple the adapter 108 to the cap 104.
[0058] FIG. 4G illustrates a side view of a third sample container sealing unit 400c in accordance with embodiments provided herein. With reference to FIG. 4G, the third sample container sealing unit 400c includes the adapter 108 of FIGS. 1A-2B without the needle 124 attached to the cover 120 (e.g., glued, fused, or otherwise attached). In the embodiment of FIG. 4G, the adapter 108 and cap 104 are pre-assembled as a unit. Accordingly, the needle 124 may be replaced with a pass through 406 that extends from the vacuum channel 118 of the adapter 108 to an interior region 408 of the cap 104 (as shown). The pass through has a first end 410a having an opening into the vacuum channel 118 of the adapter body 110 and a second end 410b extending through the cap 104 so that, when the cap 104 seals a vacuum-sealed sample container (e.g., vacuum-sealed sample container 102), both the sample container and the vacuum channel 118 of the adapter body 110 are under vacuum.
[0059] Viewing of the vacuum channel 118 for hemolysis detection may be performed through the cover 120, although a similar pre-assembled unit in which the vacuum channel 118 is viewed through a sidewall of the adapter 108 may be provided (as described above with reference to FIGS. 3A-3C). FIG. 4H illustrates a third vacuum-sealed sample container system 402c formed by using the third sample container sealing unit 400c to seal the vacuum-sealed sample container 102.
[0060] Advantages of the third sample container sealing unit 400c of FIG. 4G include ease of manufacture and fewer parts. Additionally, no needle is present, and the adapter 108 and cap 104 are pre-attached. As stated, a similar pre- assembled sample container sealing unit may be constructed based on the adapter 108 of FIGS. 3A-3C in which the vacuum channel 118 of the adapter 108 is viewed through the sidewall 112. The needle 124 may be replaced with a pass through in such an embodiment.
[0061] FIG. 5 illustrates a flowchart of a method 500 of determining a property of a blood sample in accordance with embodiments provided herein. With reference to FIG. 5, method 500 begins in block 502 with receiving a blood draw adapter that includes an adapter body having a sidewall, an end surface, a vacuum channel and a viewing region that allows viewing of the vacuum channel. The blood draw adapter also includes a needle having a first end that opens into the vacuum channel and a second end that extends from the adapter body. Example blood draw adapters are described above with reference to FIGS. 1A-4F, each including a sidewall 112, end surface 114, vacuum channel 118, and viewing region 122. In some embodiments, a blood draw adapter (e.g., adapter 108) may be provided in sterile packaging that may be removed prior to use.
[0062] Method 500 further includes, in block 504, employing the needle of the blood draw adapter to pierce the cap of thevacuum-sealed sample container so as to create a vacuum within the vacuum channel through the needle based on a vacuum within the vacuum-sealed sample container. As illustrated in FIGS. 1A-1D and 3A-3C, a blood draw adapter (e.g., adapter 108) having a needle 124 may be attached to a cap 104 of a vacuum- sealed sample container 102 such that the needle 124 pierces the cap 104. This exposes the vacuum channel 118 of the adapter 108 to the same vacuum that is present in the vacuum- sealed sample container 102 (e.g., equilibrating the vacuum levels in the vacuum channel 118 and vacuum-sealed sample container 102).
[0063] In block 506, method 500 includes employing the vacuum of the vacuum-sealed sample container to draw blood into the vacuum-sealed sample container. For example, as shown in FIG. 1D, a blood draw needle 130 may be inserted into vacuum-sealed sample container 102 during blood sample collection. FIG. 6 is a side view illustrating the collection of a blood sample 602 from a patient arm 604 using the blood draw needle 130, vacuum-sealed sample container 102, and adapter 108. A first end 134a of blood draw needle 130 is inserted into a vein (not shown) of the patient arm 604, and then vacuum-sealed sample container 102 is inserted into the blood draw needle shield 132 so that the opposite end 134b of blood draw needle 130 travels through the adapter 108 and the cap 104 into the vacuum-sealed sample container 102. Vacuum within the vacuum-sealed sample container 102 then draws blood from the patient arm 604 into the vacuum-sealed sample container 102.
[0064] As shown in FIG. 6, vacuum-sealed sample container 102 is positioned at an angle θ relative to the patient arm 604. In some embodiments, an angle of approximately 40 to 50 degrees may be employed, although other collection angles may be used. The angle may be selected to allow blood within vacuum-sealed sample container 102 to travel into needle 124(or pass through 406 of FIG. 4G) of adapter 108 (and into vacuum channel 118 for viewing). Further, as shown in FIG. 6, the blood draw needle 130 of shield 132 and the needle 124 (or pass through 406) of the adaptor 108 are positioned offset from each other (i.e., not aligned) such as to near- simultaneously (i.e., sequentially in one step during blood draw from a patient) allow collection of the blood sample in the vacuum-sealed sample container 102 and travel of the blood within the vacuum-sealed sample container 102 to the adaptor 108 during blood draw from the patient. In one exemplary embodiment, the needle 124 (or pass through 406) of the adaptor 108 may be positioned offset from a center of the adaptor 108 and a center of the cap 104, while the blood draw needle 130 is positioned at a center of the cap 104 or at any other position offset from the needle 124 (or pass through 406).
[0065] As blood is drawn into the vacuum-sealed sample container 102, in block 508, method 500 includes employing the vacuum of the vacuum channel of the blood draw adapter to draw blood from the vacuum-sealed sample container into the vacuum channel of the blood draw adapter. That is, a portion of the blood drawn into the vacuum-sealed sample container 102 is also drawn into the vacuum channel 118 of the adapter 108 due to the vacuum present therein (until the pressure equilibrates). As described previously with reference to FIG. 2B, in some embodiments, the vacuum channel 118 may include a filter mechanism 204 configured to separate at least one component from a blood sample that travels through the needle 124 into the vacuum channel 118. For example, for hemolysis detection, the filter mechanism 204 may be configured to filter red blood cells from the blood sample. In one or more embodiments, materials of the filter mechanism 204 are selected to capture red blood cells and allow blood plasma, blood serum, and free hemoglobin to pass.
[0066] In block 510, method 500 includes viewing the blood in the vacuum channel through the viewing region of the blood draw adapter. For example, in the embodiments of FIGS. 1A-2D, the blood within vacuum channel 118 may be viewed through the viewing region 122 of cover 120 (FIG. 1A). Likewise, in the embodiments of FIGS. 3A-3C, the blood within vacuum channel 118 may be viewed through viewing region 122 of sidewall 112 (FIG. 3B). Note that a medical technician may advantageously view the blood sample within the vacuum channel 118 before, during and / or after the blood draw (e.g., to detect hemolysis).
[0067] In block 512, method 500 includes identifying a property of the blood in the vacuum channel based on the viewing. For example, the blood sample within the vacuum channel 118 may be viewed to detect hemolysis. As stated, in one or more embodiments, the vacuum channel 118 may include a colorimetric reagent 206 that changes color in response to a component within a blood sample within the vacuum channel 118 of the adapter body 110. In some embodiments, the colorimetric reagent 206 may change color in response to hemoglobin.
[0068] FIG. 7 illustrates a flowchart of another method 700 of determining a property of a blood sample in accordance with embodiments provided herein. With reference to FIG. 7, method 700 begins in block 702 with receiving a vacuum-sealed sample container system having a vacuum-sealed sample container sealed with a cap and an adapter coupled to the cap, the adapter having a vacuum channel, a viewing region that allows viewing of the vacuum channel, and a pass through that extends from the vacuum channel through the cap so that both the vacuum-sealed sample container and the vacuum channel of the adapter are under a vacuum. An example adapter 108 having a pass through 406 is shown in FIG. 4G, and an example vacuum- sealed sample container system 402c is shown in FIG. 4H.
[0069] In block 704, method 700 includes employing thevacuum of the vacuum-sealed sample container to draw blood into the vacuum-sealed sample container. For example, as shown in FIGS. 1D and 6, a blood draw needle 130 may be inserted into vacuum-sealed sample container 102 during blood sample collection. The first end 134a of blood draw needle 130 may be inserted into the patient arm 604, and then vacuum-sealed sample container 102 may be inserted into the blood draw needle shield 132 so that the opposite end 134b of blood draw needle 130 travels through the adapter 108 and the cap 104 into the vacuum-sealed sample container 102. Vacuum within the vacuum-sealed sample container 102 then draws blood from the patient arm 604 into the vacuum-sealed sample container 102.
[0070] In block 706, method 700 includes employing the vacuum of the vacuum channel of the adapter to draw blood from the vacuum-sealed sample container into the vacuum channel of the adapter. Thereafter, in block 708, method 700 includes viewing the blood in the vacuum channel through the viewing region of the adapter. In block 710, method 700 includes identifying a property of the blood in the vacuum channel based on the viewing. For example, adapter 108 may draw blood into the vacuum channel 118 and a medical technician may view the blood in the vacuum channel 118 through viewing region 122 and identify a property of the blood (e.g., hemolysis level).
[0071] While many of the embodiments described herein relate to hemolysis detection, it will be understood that virtually any reagent used in the fields of biological, chemical, or biochemical analyses and assays may be used in the apparatus (e.g., adapters) and methods of the presently claimed and disclosed inventive concept(s). It is contemplated that these reagents may undergo physical and / or chemical changes when bound to an analyte of interest whereby the intensity, nature, frequency, or type of signal generated by the reagent-analyte complex is directly proportional or inversely proportional to the concentration of the analyteexisting within the fluid sample. These reagents may contain indicator dyes, metal, enzymes, polymers, antibodies, and electrochemically reactive ingredients and / or chemicals that, when reacting with an analyte(s) of interest, may exhibit change in color.
[0072] Assays, including, but not limited to, immunoassays, nucleic acid capture assays, lipid-based assays, and serology- based assays, can be developed for a multiplexed panel of proteins, peptides, and nucleic acids which may be contained within a liquid test sample, with such proteins and peptides including, for example but not by way of limitation, albumin, microalbumin, cholesterol, triglycerides, high-density lipoproteins, low-density lipoproteins, hemoglobin, myoglobin, a-1-microglobin, immunoglobins, enzymes, proteins, glycoproteins, protease inhibitors, drugs, cytokines, creatinine, and glucose. The apparatus and method(s) disclosed and / or claimed herein may be used for the analysis of any liquid test sample, including, without limitation, whole blood, plasma, serum, or urine. In accordance with one aspect, there are provided devices, systems, and processes for determining a presence of hemolysis in a sample suspected of having hemolysis (e.g., broken cell red blood cell fragment(s), hemoglobin, etc.).
[0073] The foregoing description discloses only example embodiments of the invention; modifications of the above disclosed apparatus and methods which fall within the scope of the invention will be readily apparent to those of ordinary skill in the art.
[0074] Accordingly, while the present invention has been disclosed in connection with the example embodiments thereof, it should be understood that other embodiments may fall within the spirit and scope of the invention, as defined by the following claims.Illustrative Embodiments
[0075] The following provides a non-limiting list of illustrative embodiments of this disclosure:
[0076] Example Embodiment 1. An adapter for use during a blood draw, comprising:
[0077] an adapter body having a sidewall, an end surface, a vacuum channel, and a viewing region that allows viewing of the vacuum channel of the adapter body; and
[0078] a needle having a first end and a second end, wherein the first end of the needle has an opening into the vacuum channel of the adapter body and the second end of the needle extends from the adapter body, wherein, when the adapter body is placed over and pressed against a cap of a vacuum-sealed sample container, the needle is configured to pierce the cap of the vacuum-sealed sample container and create a vacuum within the vacuum channel of the adapter body.
[0079] Example Embodiment 2. The adapter of Example Embodiment 1 wherein the sidewall and end surface form a cavity sized to fit over the cap of the vacuum-sealed sample container and wherein the second end of the needle extends into the cavity of the adapter body.
[0080] Example Embodiment 3. The adapter of any one of the preceding Example Embodiments 1-2 wherein the vacuum channel of the adapter body includes a cavity opening that extends into the cavity.
[0081] Example Embodiment 4. The adapter of any one of the preceding Example Embodiments 1-3 wherein the needle extends through the cavity opening of the vacuum channel of the adapter body.
[0082] Example Embodiment 5. The adapter of any of any one of the preceding Example Embodiments 1-4 wherein the vacuum channel of the adapter body is formed in the end surface of the adapter body.
[0083] Example Embodiment 6. The adapter of any one of Example Embodiments 1-5 wherein the vacuum channel of the adapter body is formed in a sidewall of the adapter body.
[0084] Example Embodiment 7. The adapter of any one of Example Embodiments 1-6 further comprising a filter mechanism configured to separate at least one component from a blood sample that travels through the needle into the vacuum channel.
[0085] Example Embodiment 8. The adapter of any one of the preceding Example Embodiments 1-7 wherein the at least one component comprises red blood cells.
[0086] Example Embodiment 9. The adapter of any one of the preceding Example Embodiments 1-8 wherein the filter mechanism comprises at least one of an asymmetric membrane, cellulose, cellulose coated with lectin, and an anti-human red blood cell antibody-coated membrane.
[0087] Example Embodiment 10. The adapter of any one of Example Embodiments 1-9 wherein the vacuum channel of the adapter body includes a colorimetric reagent that changes color in response to a component within a blood sample within the vacuum channel of the adapter body.
[0088] Example Embodiment 11. The adapter of any one of the preceding Example Embodiments 1-10 wherein the colorimetric reagent changes color in response to hemoglobin.
[0089] Example Embodiment 12. The adapter of any one of Example Embodiments 1-11 further comprising a cover sized to fit over the adapter body and wherein the first end of the needle is coupled to the cover.
[0090] Example Embodiment 13. The adapter of any one of the preceding Example Embodiments 1-12 wherein the cover includes a passage and the adapter body includes a further passage, wherein the passage of the cover and the further passage of the adapter body align so as to allow a blood draw needle to pass through the adapter.
[0091] Example Embodiment 14. The adapter of any one of the preceding Example Embodiments 1-13 wherein the passage of the cover and the further passage of the adapter body are sized to allow a butterfly blood-draw needle to pass through the adapter.
[0092] Example Embodiment 15. A sample container sealing unit for use with a vacuum-sealed sample container, comprising:
[0093] a cap configured to seal an end of a vacuum-sealed sample container;
[0094] an adapter body coupled to the cap, the adapter body having a vacuum channel and a viewing region that allows viewing of the vacuum channel of the adapter body; and
[0095] a pass through having a first end and a second end, wherein the first end of the pass through has an opening into the vacuum channel of the adapter body and the second end of the pass through extends through the cap so that, when the cap seals the vacuum-sealed sample container, both the vacuum-sealed sample container and the vacuum channel of the adapter body are under vacuum.
[0096] Example Embodiment 16. The sample container sealing unit of any one of the preceding Example Embodiments wherein the vacuum channel of the adapter body is formed in an end surface of the adapter body.
[0097] Example Embodiment 17. The sample container sealing unit of any one of the preceding Example Embodiments wherein the vacuum channel is formed in a sidewall of the adapter body.
[0098] Example Embodiment 18. The sample container sealing unit of any one of the preceding Example Embodiments further comprising a filter mechanism configured to separate at least one component from a blood sample that travels through the pass through into the vacuum channel.
[0099] Example Embodiment 19. The sample container sealing unit of any one of the preceding Example Embodiments wherein the at least one component comprises red blood cells.
[0100] Example Embodiment 20. The sample container sealing unit of any one of the preceding Example Embodiments wherein the filter mechanism comprises at least one of an asymmetric membrane, cellulose, cellulose coated with lectin, and an anti-human red blood cell antibody-coated membrane.
[0101] Example Embodiment 21. The sample container sealing unit of any one of the preceding Example Embodiments wherein the vacuum channel of the adapter body includes a colorimetric reagent that changes color in response to a component within a blood sample within the vacuum channel of the adapter body.
[0102] Example Embodiment 22. The sample container sealing unit of any one of the preceding Example Embodiments wherein the colorimetric reagent changes color in response to hemoglobin.
[0103] Example Embodiment 23. The sample container sealing unit of any one of the preceding Example Embodiments wherein the adapter body has a cover that includes the viewing region.
[0104] Example Embodiment 24. The sample container sealing unit of any one of the preceding Example Embodiments wherein the adapter body includes a passage that allows a blood draw needle to pass through the adapter body.
[0105] Example Embodiment 25. The sample container sealing unit of any one of the preceding Example Embodiments wherein the passage is sized to allow a butterfly blood-draw needle to pass through the adapter body.
[0106] Example Embodiment 26. A method of determining a property of a blood sample, comprising:
[0107] receiving a blood draw adapter that includes:
[0108] an adapter body having a sidewall, an end surface, a vacuum channel and a viewing region that allows viewing of the vacuum channel; and
[0109] a needle having a first end that opens into the vacuum channel and a second end that extends from the adapter body;
[0110] employing the needle of the blood draw adapter to pierce a cap of a vacuum-sealed sample container so as to create a vacuum within the vacuum channel through the needle based on a vacuum within the vacuum-sealed sample container;
[0111] employing the vacuum of the vacuum-sealed sample container to draw the blood sample into the vacuum- sealed sample container;
[0112] employing the vacuum of the vacuum channel of the blood draw adapter to draw the blood sample from the vacuum-sealed sample container into the vacuum channel of the blood draw adapter;
[0113] viewing the blood sample in the vacuum channel through the viewing region of the blood draw adapter; and
[0114] identifying a property of the blood sample in the vacuum channel based on the viewing.
[0115] Example Embodiment 27. The method of any one of the preceding Example Embodiments wherein the adapter body includes a filter mechanism and further comprising employing the filter mechanism of the blood draw adapter to filter at least one component from the blood sample.
[0116] Example Embodiment 28. The method of any one of the preceding Example Embodiments wherein employing the filter mechanism comprises filtering red blood cells from the blood sample.
[0117] Example Embodiment 29. The method of any one of the preceding Example Embodiments wherein viewing the blood sample comprises viewing the blood sample through a cover of the blood draw adapter.
[0118] Example Embodiment 30. The method of any one of the preceding Example Embodiments wherein viewing the blood sample comprises viewing the blood sample through the sidewall of the blood draw adapter.
[0119] Example Embodiment 31. A method of determining a property of a blood sample, comprising:
[0120] receiving a vacuum-sealed sample container system having:
[0121] a vacuum-sealed sample container sealed with a cap; and
[0122] an adapter coupled to the cap, the adapter having a vacuum channel, a viewing region that allows viewing of the vacuum channel, and a pass through that extends from the vacuum channel through the cap so that both the vacuum-sealed sample container and the vacuum channel of the adapter are under a vacuum;
[0123] employing the vacuum of the vacuum-sealed sample container to draw the blood sample into the vacuum- sealed sample container;
[0124] employing the vacuum of the vacuum channel of the adapter to draw the blood sample from the vacuum-sealed sample container into the vacuum channel of the adapter;
[0125] viewing the blood sample in the vacuum channel through the viewing region of the adapter; and
[0126] identifying a property of the blood sample in the vacuum channel based on the viewing.
[0127] Example Embodiment 32. The method of any one of the preceding Example Embodiments wherein the adapter includes a filter mechanism and further comprising employing the filter mechanism of the adapter to filter at least one component from the blood sample.
[0128] Example Embodiment 33. The method of any one of the preceding Example Embodiments wherein employing the filtermechanism comprises filtering red blood cells from the bloodsample.
Claims
WHAT IS CLAIMED IS:
1. An adapter for use during a blood draw, comprising: an adapter body having a sidewall, an end surface, a vacuum channel, and a viewing region that allows viewing of the vacuum channel of the adapter body; and a needle having a first end and a second end, wherein the first end of the needle has an opening into the vacuum channel of the adapter body and the second end of the needle extends from the adapter body, wherein, when the adapter body is placed over and pressed against a cap of a vacuum-sealed sample container, the needle is configured to pierce the cap of the vacuum-sealed sample container and create a vacuum within the vacuum channel of the adapter body.
2. The adapter of claim 1 wherein the sidewall and end surface form a cavity sized to fit over the cap of the vacuum- sealed sample container and wherein the second end of the needle extends into the cavity of the adapter body.
3. The adapter of claim 2 wherein the vacuum channel of the adapter body includes a cavity opening that extends into the cavity.
4. The adapter of claim 3 wherein the needle extends through the cavity opening of the vacuum channel of the adapter body.
5. The adapter of claim 1 wherein the vacuum channel of the adapter body is formed in the end surface of the adapter body.
6. The adapter of claim 1 wherein the vacuum channel of the adapter body is formed in a sidewall of the adapter body.
7. The adapter of claim 1 further comprising a filter mechanism configured to separate at least one component from a blood sample that travels through the needle into the vacuum channel.
8. The adapter of claim 7 wherein the at least one component comprises red blood cells.
9. The adapter of claim 7 wherein the filter mechanism comprises at least one of an asymmetric membrane, cellulose, cellulose coated with lectin, and an anti-human red blood cell antibody-coated membrane.
10. The adapter of claim 1 wherein the vacuum channel of the adapter body includes a colorimetric reagent that changes color in response to a component within a blood sample within the vacuum channel of the adapter body.
11. The adapter of claim 10 wherein the colorimetric reagent changes color in response to hemoglobin.
12. The adapter of claim 1 further comprising a cover sized to fit over the adapter body and wherein the first end of the needle is coupled to the cover.
13. The adapter of claim 12 wherein the cover includes a passage and the adapter body includes a further passage, wherein the passage of the cover and the further passage of the adapter body align so as to allow a blood draw needle to pass through the adapter.
14. The adapter of claim 13 wherein the passage of the cover and the further passage of the adapter body are sized toallow a butterfly blood-draw needle to pass through the adapter.
15. A sample container sealing unit for use with a vacuum-sealed sample container, comprising: a cap configured to seal an end of a vacuum-sealed sample container; an adapter body coupled to the cap, the adapter body having a vacuum channel and a viewing region that allows viewing of the vacuum channel of the adapter body; and a pass through having a first end and a second end, wherein the first end of the pass through has an opening into the vacuum channel of the adapter body and the second end of the pass through extends through the cap so that, when the cap seals the vacuum-sealed sample container, both the vacuum- sealed sample container and the vacuum channel of the adapter body are under vacuum.
16. The sample container sealing unit of claim 15 wherein the vacuum channel of the adapter body is formed in an end surface of the adapter body.
17. The sample container sealing unit of claim 15 wherein the vacuum channel of the adapter body is formed in a sidewall of the adapter body.
18. The sample container sealing unit of claim 15 further comprising a filter mechanism configured to separate at least one component from a blood sample that travels through the pass through into the vacuum channel.
19. The sample container sealing unit of claim 18 wherein the at least one component comprises red blood cells.
20. The sample container sealing unit of claim 18 wherein the filter mechanism comprises at least one of an asymmetric membrane, cellulose, cellulose coated with lectin, and an anti-human red blood cell antibody-coated membrane.
21. The sample container sealing unit of claim 15 wherein the vacuum channel of the adapter body includes a colorimetric reagent that changes color in response to a component within a blood sample within the vacuum channel of the adapter body.
22. The sample container sealing unit of claim 21 wherein the colorimetric reagent changes color in response to hemoglobin.
23. The sample container sealing unit of claim 15 wherein the adapter body has a cover that includes the viewing region.
24. The sample container sealing unit of claim 15 wherein the adapter body includes a passage that allows a blood draw needle to pass through the adapter body.
25. The sample container sealing unit of claim 24 wherein the passage is sized to allow a butterfly blood-draw needle to pass through the adapter body.
26. A method of determining a property of a blood sample, comprising: receiving a blood draw adapter that includes: an adapter body having a sidewall, an end surface, a vacuum channel and a viewing region that allows viewing of the vacuum channel; anda needle having a first end that opens into the vacuum channel and a second end that extends from the adapter body; employing the needle of the blood draw adapter to pierce a cap of a vacuum-sealed sample container so as to create a vacuum within the vacuum channel through the needle based on a vacuum within the vacuum-sealed sample container; employing the vacuum of the vacuum-sealed sample container to draw the blood sample into the vacuum-sealed sample container; employing the vacuum of the vacuum channel of the blood draw adapter to draw the blood sample from the vacuum- sealed sample container into the vacuum channel of the blood draw adapter; viewing the blood sample in the vacuum channel through the viewing region of the blood draw adapter; and identifying a property of the blood sample in the vacuum channel based on the viewing.
27. The method of claim 26 wherein the adapter body includes a filter mechanism and further comprising employing the filter mechanism of the blood draw adapter to filter at least one component from the blood sample.
28. The method of claim 27 wherein employing the filter mechanism comprises filtering red blood cells from the blood sample.
29. The method of claim 26 wherein viewing the blood sample comprises viewing the blood sample through a cover of the blood draw adapter.
30. The method of claim 26 wherein viewing the blood sample comprises viewing the blood sample through the sidewall of the blood draw adapter.
31. A method of determining a property of a blood sample, comprising: receiving a vacuum-sealed sample container system having: a vacuum-sealed sample container sealed with a cap; and an adapter coupled to the cap, the adapter having a vacuum channel, a viewing region that allows viewing of the vacuum channel, and a pass through that extends from the vacuum channel through the cap so that both the vacuum- sealed sample container and the vacuum channel of the adapter are under a vacuum; employing the vacuum of the vacuum-sealed sample container to draw the blood sample into the vacuum-sealed sample container; employing the vacuum of the vacuum channel of the adapter to draw the blood sample from the vacuum-sealed sample container into the vacuum channel of the adapter; viewing the blood sample in the vacuum channel through the viewing region of the adapter; and identifying a property of the blood sample in the vacuum channel based on the viewing.
32. The method of claim 31 wherein the adapter includes a filter mechanism and further comprising employing the filter mechanism of the adapter to filter at least one component from the blood sample.
33. The method of claim 32 wherein employing the filter mechanism comprises filtering red blood cells from the bloodsample.