Capillary sample collection tube

Abstract

A sample collection tube or assembly includes a coupling portion configured to couple with a fluid collection device, a reservoir portion in fluid communication with the coupling portion, and a sample separation assembly slidingly received at least partially within the reservoir portion. The sample collection assembly is assembled by providing the coupling portion and the reservoir portion and sliding the sample separation assembly at least partially into the reservoir portion.

Description

CAPILLARY SAMPLE COLLECTION TUBEThis application claims benefit to provisional application No. 63 / 789,343, filed on April 15, 2025, the disclosure of which is incorporated herein by reference in its entirety.Field

[0001] The present disclosure relates generally to sample collection devices and more particularly to blood sample collection devices.Background

[0002] Blood sample collection has historically been performed in a clinical setting. This requires a patient to travel to, for example, a physician’s office and wait for a professional to make the collection. This process is time consuming. In response, at-home collections systems have been developed which allow an individual to obtain their own blood sample in the privacy of their own home. The sample collection has historically required individuals to lance, e.g., a fingertip to obtain one or several drops of blood. While effective, this process is painful since the finger tips have a high concentration of nerves. Additionally, the sample is typically limited to only a few drops of blood.

[0003] In response, so-called capillary collection systems have been developed.These systems typically include a fluid collection device which attaches to the arm of the individual. Once attached, small needles puncture the skin of the individual and a pump is used to create vacuum in the device and capillary blood is obtained. The blood isgenerally gravity fed into a collection reservoir attached to the bottom of the fluid collection device. One reservoir used with the system is a “microtainer” which is a small tube which holds about 0.5 to 1.0 milliliters of sample.

[0004] While useful in collecting larger blood samples, microtainers can leak or be broken. This results in rejection or spillage of the fluid sample.

[0005] What is needed is a blood sample collection system which reduces the potential for rejection or leakage of an obtained sample. It would be beneficial if the system provided a chemically stable manner of storing and transporting the sample.

[0006] According to the present disclosure, a sample collection assembly includes a coupling portion configured to couple with a fluid collection device, a reservoir portion in fluid communication with the coupling portion, and a sample separation assembly slidingly received at least partially within the reservoir portion.

[0007] In accordance with one or more embodiments, the reservoir portion includes at least one sample assembly guide structure, and the sample separation assembly is configured to slide along the at least one sample assembly guide structure to a position whereat a portion of the sample separation assembly is located directly beneath the coupling portion.

[0008] In accordance with one or more embodiments the coupling portion includes a delivery channel leading downwardly to a mouth, the delivery channel has a first diameter, the mouth has a second diameter, the second diameter is smaller than the firstdiameter, and the portion of the sample separation assembly is located directly beneath the mouth.

[0009] In accordance with one or more embodiments, the sample separation assembly includes a separation stack. The separation stack includes a lower non-absorbent layer and a plurality of separation layers located above the lower non-absorbent layer.

[0010] In accordance with one or more embodiments, the sample separation assembly includes a carrier, the carrier configured to slidingly engage the at least one sample assembly guide structure, and slidingly receive the separation stack.

[0011] In accordance with one or more embodiments, the carrier includes a first sidewall, a second sidewall, and at least one rib extending between the first sidewall and the second sidewall. A first of the at least one rib includes a lower surface configured to slidingly engage the at least one sample assembly guide structure, and a second of the at least one rib includes an upper surface configured to slidingly engage the separation stack.

[0012] In accordance with one or more embodiments, the first of the at least one rib includes an upper surface configured to slidingly engage the separation stack, and the second of the at least one rib includes a lower surface configured to slidingly engage the at least one sample assembly guide structure.

[0013] In accordance with one or more embodiments, the carrier further includes at least one stack guide structure extending outwardly from the first sidewall, the at least one stack guide structure configured to slidingly guide insertion of the separation stack within the carrier.

[0014] In accordance with one or more embodiments, the first sidewall includes an upper surface, the reservoir portion includes at least one further sample assembly guide structure, and the upper surface of the first sidewall is configured to slide along the at least one further sample assembly guide structure to the position whereat the portion of the sample separation assembly is located directly beneath the coupling portion.

[0015] In accordance with one or more embodiments, the carrier further includes a tab. The tab is configured to extend outwardly of the reservoir portion while the portion of the sample separation assembly is located directly beneath the coupling portion.

[0016] In accordance with one or more embodiments, the sample collection assembly further includes a cap. The cap is configured to sealingly engage the reservoir portion. The cap is further configured to clamp the carrier against the reservoir portion by abutment with the tab.

[0017] In accordance with one or more embodiments, the carrier further includes a nose. The cap is configured to clamp the nose against the reservoir portion by the abutment with the tab.

[0018] In accordance with one or more embodiments, the sample collection assembly further includes a further reservoir portion in fluid communication with the coupling portion, and a further sample separation assembly slidingly received at least partially within the reservoir portion.

[0019] In accordance with one or more embodiments, the sample collection assembly further includes a stop located beneath the coupling portion and configured to abut the sample separation assembly and the further sample separation assembly.

[0020] In accordance with one embodiment, the sample collection assembly is assembled by providing the coupling portion and the reservoir portion, and sliding the sample separation assembly at least partially into the reservoir portion.

[0021] In accordance with one or more embodiments, the method includes sliding the sample separation assembly along at least one sample assembly guide structure to a position whereat a portion of the sample separation assembly is located directly beneath the coupling portion.

[0022] In accordance with one or more embodiments, the method includes forming the sample separation assembly by sliding a separation stack into a carrier, the separation stack including a lower non-absorbent layer and a plurality of separation layers located above the lower non-absorbent layer.

[0023] In accordance with one or more embodiments of the method, sliding the sample separation assembly at least partially into the reservoir portion comprises sliding a lower surface of a first rib of the carrier along at least one sample assembly guide structure, and forming the sample separation assembly comprises sliding the separation stack into the carrier by slidingly engaging an upper surface of a second rib of the carrier. In such methods the first rib and the second rib extend between a first sidewall of the carrier and a second sidewall of the carrier.

[0024] In accordance with one or more embodiments, forming the sample separation assembly includes slidingly guiding insertion of the separation stack within the carrier with at least one stack guide structure extending outwardly from the first sidewall, the at least one stack guide structure configured to slidingly engage an upper surface of one of the plurality of separation layers.

[0025] In accordance with one or more embodiments, the method includes clamping the sample separation assembly at least partially within the reservoir portion by abutment of a cap against a tab of the carrier.of the Drawings

[0026] The above-described features and advantages, as well as others, will become more readily apparent to those of ordinary skill in the art by reference to the following detailed description and accompanying drawings.

[0027] FIG. 1 depicts a side perspective view of a sample collection assembly;

[0028] FIG. 2 depicts a side cross-sectional view of the sample collection assembly of FIG. 1;

[0029] FIG. 3 depicts an end plan view of the sample collection assembly of FIG. 1;

[0030] FIG. 4 depicts a side cross-sectional view of the sample collection assembly of FIG. 1 with a sample separation assembly inserted and with an elastomeric stopper;

[0031] FIG. 5 depicts an end plan view of the sample collection assembly of FIG. 4 with the plastic plug removed;

[0032] FIG. 6 depicts a side perspective view of an alternative embodiment of a sample collection assembly with two sample separation tracks;

[0033] FIG. 7 depicts a side perspective view of a sample collection assembly;

[0034] FIG. 8 depicts a side cross-sectional view of the sample collection assembly of FIG. 7;

[0035] FIG. 9 depicts an end plan view of the sample collection assembly of FIG. 7;

[0036] FIG. 10 depicts a top plan view of the sample collection assembly of FIG. 7;

[0037] FIG. 11 depicts a side cross-sectional view of a sample separation assembly of the sample collection assembly of FIG. 7;

[0038] FIG. 12 depicts a bottom perspective view of a carrier of the sample separation assembly of FIG. 11;

[0039] FIG. 13 depicts a top plan view of the carrier of the sample separation assembly of FIG. 11;

[0040] FIG. 14 depicts a bottom plan view of the carrier of the sample separation assembly of FIG. 11;

[0041] FIG. 15 depicts a side plan view of the carrier of the sample separation assembly of FIG. 11;

[0042] FIG. 16 depicts a cross-sectional view of a separation stack of the sample separation assembly of FIG. 11 with eight separation layers;

[0043] FIG. 17 depicts a cross-sectional view of a separation stack of the sample separation assembly of FIG. 11 with six separation layers;

[0044] FIG. 18 depicts a cross-sectional view of a separation stack of the sample separation assembly of FIG. 11 with a non-absorbent layer which is larger than the separation layers;

[0045] FIG. 19 depicts a cross-sectional view of a separation stack of the sample separation assembly of FIG. 11 without a non-absorbent layer;

[0046] FIG. 20 depicts a cross-sectional view of insertion of a separation stack into a carrier;

[0047] FIG. 21 depicts a cross-sectional view of the separation stack positioned within the carrier;

[0048] FIG. 22 depicts a cross-sectional view of insertion of a separation assembly into a reservoir portion;

[0049] FIG. 23 depicts a cross-sectional view of the separation assembly partially inserted into the reservoir portion of FIG. 22 and a cap aligned with the reservoir portion;

[0050] FIG. 24 depicts a cross-sectional view of the separation assembly clamped by the cap partially within the reservoir portion of FIG. 23;

[0051] FIG. 25 depicts a side plan view of an alternative embodiment of a sample collection assembly with two sample separation tracks; and

[0052] FIG. 26 depicts a partial cross-sectional view of the sample collection assembly of FIG. 25.Detailed Description

[0053] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and described in the following written description. It is to be understood that no limitation to the scope of the disclosure is thereby intended. It is further to be understood that the present disclosure includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the disclosure as would normally occur to one skilled in the art to which this disclosure pertains.

[0054] FIG. 1 depicts a side perspective view of a sample collection tube or assembly 100. The sample collection assembly 100 includes a coupling portion 102, a delivery portion 104, and a reservoir portion 106. The reservoir portion 106 in this embodiment includes a threaded portion 108. The threaded portion 108 is configured to threadedlyengage a cap 110 to provide a fluid tight closure of the reservoir portion 106. To this end the cap 110 includes an internally threaded portion as discussed below.

[0055] The sample collection assembly 100 in one embodiment is configured as a capillary sample collection assembly. Accordingly, the coupling portion 102 is configured to couple with a fluid collection device. The fluid collection device (not shown) obtains the fluid and directs the fluid, typically using gravity, to the sample collection assembly 100. The fluid enters the coupling portion 102 which includes a delivery channel 114 which opens to a delivery chamber 116 through a mouth 118 as shown in FIG. 2. At the top of the delivery chamber 116 and aligned with the 118 is a disrupter bar 120 also shown in FIG. 3. The delivery chamber 116 opens to a sample separation chamber 122. A pair of sample assembly guide structures in the form of sample assembly guide slots 124 extends along the sample separation chamber 122.

[0056] The sample assembly guide slots 124 are provided to position a sample separation assembly 130 within the sample collection assembly 100 as shown in FIG. 4. In the embodiment of FIG. 4, a plastic plug 132 may be used in place of the cap 110. In embodiments incorporating a plastic plug 132, the threaded portion 108 may be omitted as shown in FIG. 4. Alternatively, the plastic plug 132 may be used with a reservoir portion 106 including the threaded portion 108.

[0057] The plastic plug 132 includes a slot 134 in which a non-absorbent layer 136 of the sample separation assembly 130 is frictionally engaged. The engagement of the nonabsorbent layer 136 within the slot 134 allows the sample separation assembly 130 to be inserted and removed from the sample separation chamber 122 using the plastic plug 132.In embodiments incorporating a cap 110, the sample separation assembly 130 is positioned using just the non-absorbent layer 136.

[0058] Located on top of the non-absorbent layer 136 are separation layers 138. The non-absorbent layer 136 is both longer than the separation layers 138 and wider than the separation layers 138. In particular, as shown in FIG. 5, the non-absorbent layer 136 is wider than the separation layers 138 (only three separation layers 138 are shown for purpose of clarity) because the non-absorbent layer 136 is located within the sample assembly guide slots 124.

[0059] In some embodiments such as the embodiment of FIG. 4, the non-absorbent layer 136 also extends farther into the delivery chamber 116 than the separation layers 138 and, in some embodiments, abuts the wall (on the right as depicted in FIG. 4). In other embodiments, the non-absorbent layer 136 is slightly separated from the wall on the right as depicted in FIG. 4 when fully inserted.

[0060] The number of separation layers 138 used in any particular embodiment is a function of the amount of sample desired to be separated. The sample collection assembly 100 includes about six to eight separation layers 138 in the embodiment depicted so as to collect and separate about 250-500 pL of sample. The separation layers 138 in this embodiment are made from Whatman LF-1 material, commercially available from Global Life Sciences Solutions USA LLC of Wilmington, Delaware. Other suitable material may be used, such as, but not limited to, porous materials that allow liquid and suspended solids to differentially flow and separate based on the molecular size of the molecules. Additionally, the characteristics of the separation layers 138 may be modified by incorporating designs that utilize other physical forces that affect the flow ofsubstances through the separation layers 138. Such physical forces include hydrophobic or hydrophilic interactions as well as ionic interactions. Additionally, temporary hydrogen bonding interactions and gravitational effects may be used to augment or retard flow to provide the desired separation or alteration of a separation of the flowing liquids and suspended cells or other solid materials.

[0061] The non-absorbent layer 136 in some embodiments is made from MYLAR, which is used for its imperviousness to liquid penetration. Other materials which may be used to form an acceptable liquid barrier include thin sheets of Polyethylene, porous UHMWPE film, FEP film, polyester treated sheeting and polypropylene. Another material which provides an acceptable liquid barrier is porous ePTF film, commercially available from DeWai Industries, Inc. of Saunderstown, RI as product number D / W 233MS. The ePTF material is a fluoropolymer material which contains a fluorocarbon material at its surface. The fluorine molecule is the most electronegative element, thereby providing a desired hydrophobic quality. Specifically, it is believed that the fluorocarbon additive to the base plastic polymer in this material and other fluoropolymers enhances the separation of plasma from the red blood cells in the touching non-absorbent layer 136.

[0062] The coupling portion 102, the delivery portion 104, and the reservoir portion 106 of the sample collection assembly 100 in one embodiment are made from a polymer or other nonabsorbent / nonreactive material.

[0063] To assemble the sample separation assembly 130 with the sample collection assembly 100, the sample separation assembly 130 is aligned within the sample separation chamber 122. The slot 134 is then positioned within the sample assemblyguide slots 124, and the sample separation assembly 130 is slid along the sample assembly guide slots 124 until the sample separation assembly 130 is positioned beneath the mouth 118 and the disrupter bar 120. The plastic plug 132 or cap 110 is then coupled with the reservoir portion 106 to provide a fluid and air-tight connection. In some instances, a protective cover is provided on the coupling portion 102 to keep contaminants from entering into the delivery channel 114.

[0064] To use the sample collection assembly 100 with the assembled sample separation assembly 130, a user positions a collection device on a desired location of the body. One such collection device is the gravity-enhanced fluid collection device of U.S. Patent No. 10,779,757 which issued September 22, 2020. The individual then couples the sample collection assembly 100 to the collection device using the coupling portion 102. The coupling portion 102 is sized to provide an air-tight and fluid tight coupling with the collecting device.

[0065] The collecting device is then operated in the manner appropriate for the device. Typically, this involves operating a plunge button which inserts one or more needles into the individual and then draws a vacuum to withdrawn blood through the punctured skin. The blood then flows, typically due to gravity, into the delivery channel 114 and to the mouth 118. As the blood contacts the disrupter bar 120, surface tension of the blood is disrupted resulting in a smooth flow of the blood into the uppermost layer of the separation layers 138 which is positioned directly beneath the mouth 118 and disrupter bar 120.

[0066] Upon entering the separation layers 138, the sample is wicked by the separation layers 138. As additional fluid is placed into the portion of the separationlayers 138 directly beneath the mouth 118, the fluid in the separation layers 138 is further forced along the separation layers 138.

[0067] The amount of fluid that is necessary to obtain the desired amount of fluid component will vary based not only on the materials used, but also based upon the geometry of the channel formed. By way of example, using materials identified above absorbent layers may be formed with a width of from about 0.6 centimeters to about 4 centimeters when separating plasma from a blood sample. Optimum separation of plasma, however, is obtained with a width of about 1 centimeter. By optimizing the separation of the plasma, less blood is needed to obtain a particular amount of plasma.

[0068] The length of the separation layers 138 is also a consideration in ensuring sufficient separation of a sample fluid. By way of example, as the volume of sample fluid deposited in the separation layers 138 increases, the red blood cells, in the case of blood, will travel further along the separation layers 138. Thus, to ensure that a sufficient separation of a sample fluid occurs in the event too much sample is provided, the length of the separation layers 138 may be increased. Typically, the capacity of the separation layers 138 will be matched to the amount of sample which the collecting device is designed to obtain.

[0069] Once the desired sample has been collected, the separation layers 138 are left to dry. In embodiments incorporating a cap 110, the cap 110 may be removed to reduce drying time.

[0070] The sample collection assembly 100 and sample separation assembly 130 may then be shipped via any desired mode of transportation to a processing facility. The dried fluid sample contained in the separation layers 138 may be stored for a relatively longtime without undue degradation of the sample. Nonetheless, the shelflife of the sample may be extended by placement of the sample collection assembly 100 and sample separation assembly 130 in a storage container.

[0071] The storage container is preferably a gas impermeable package such as a plastic or foil package. The storage container includes a resealable opening. The resealable opening may include a tamper proof mechanism to provide an indication that the storage container has been opened after a sample has been sealed therein. The storage container is sized to accept the sample collection assembly 100 therein.

[0072] In one embodiment, an oxygen scrubber (not shown) is provided with the storage container. An oxygen scrubber typically includes thin shavings including pieces of metal and a carrier desiccant that loosely holds some amount of water. When the storage container is sealed with an oxygen scrubber therein, oxygen present within the storage container reacts with the metal in the presence of water to form rust, thereby binding the oxygen. Elimination of oxygen from the atmosphere of the storage container provides increased stability for various components within the dried fluid sample. For example, lipid analytes such as HDL, cholesterol, and triglycerides may be further stabilized by removal of oxygen from the atmosphere in which the sample is stored.

[0073] If desired, the sample collection assembly 100 may be placed within the storage container and the storage container sealed before a fluid sample within the separation layers 138 has been dried. Sealing the storage container with a wet fluid sample held in the sample collection assembly 100 inhibits drying of the sample.

[0074] When desired, the sample separation assembly 130 is removed from the sample collection assembly 100 to allow for processing of the sample.

[0075] In some embodiments, it may be desired for a larger sample to be obtained. While the capacity of the sample separation assembly 130 may simply be increased, more efficient separation of the sample is obtained by providing a dual path sample separation assembly 130 for use in the dual path capillary sample collection assembly 200 shown in FIG. 6. The capillary sample collection tube 200 is substantially identical to the sample collection assembly 100 but includes two reservoir portions 206 which are fed by the coupling portion 202. The sample separation assembly (not shown) in some embodiments extends from the left threaded portion 210 to the right threaded portion 210. In other embodiments, two individual sample separation assemblies are provided, with the sample separation assemblies configured to abut directly beneath the mouth and disrupter bar.

[0076] FIG. 7 depicts a side perspective view of a capillary sample collection assembly 300. The capillary sample collection assembly 300 includes a coupling portion 302, a delivery portion 304, and a reservoir portion 306. The reservoir portion 306 in this embodiment includes a threaded portion 308. The threaded portion 308 is configured to threadedly engage a cap 310 to provide a fluid tight closure of the reservoir portion 306. To this end the cap 310 includes an internally threaded portion as discussed below.

[0077] The coupling portion 302 includes a delivery channel 314 which opens to a delivery chamber 316 through a mouth 318 as shown in FIG. 8. The mouth 318 has a diameter which is smaller than the diameter of the delivery channel 314. In one embodiment, there is no disruptor bar. In other embodiments a disruptor bar like the disruptor bar 120 of FIG. 2 is included. The delivery chamber 316 opens to a sample separation chamber 322. A lower pair of sample assembly guide structures in the form ofsample assembly guide bars 324, and a pair of upper sample assembly guide structures in the form of upper sample assembly guide bars 325 extend along the sample separation chamber 322 as further shown in FIG. 9. As shown in FIGs. 8 and 10, the delivery channel 314 defines a longitudinal axis 326 which intersects a longitudinal axis 328 defined by the reservoir portion 306.

[0078] The sample assembly guide bars 324 and the sample assembly guide bars 325 are used to position a sample separation assembly 330, shown in FIG. 11, within the capillary sample collection assembly 300. The sample separation assembly 330 includes a carrier 332 and a separation stack 334. The carrier 332, shown in FIGs. 12-15, includes a sidewall 336 and a sidewall 338. The sidewall 336 includes an upper surface 340 and the sidewall 338 includes an upper surface 342.

[0079] A number of stack guides 344 are provided near the upper surface 340 and the upper surface 342. Two supporting ribs 346 extend between the lower side of the sidewall 336 and the sidewall 338. A nose portion 348 includes a rib 350 and a standoff 352. The nose portion 348 further defines a sample reception area 354. The carrier 332 also includes a base portion 360. The base portion 360 includes a rib 362, a tab 364, and a rear wall 366. The upper surface 340 and upper surface 342 define a first plane 368 while the lower surface of the ribs 346, rib 350 and rib 362 define a second plane 370. The number of stack guides 344, the sidewall 338, the upper surface 340, the ribs 346, the rib 350, and the rib 362 define a stack receiving area 372.

[0080] The separation stack 334 is provided in a variety of formats. In one embodiment the separation stack 334 includes a non-absorbent layer 380 with separation layers 382 stacked on top as shown in FIGH. 16. In the embodiment of FIG. 16, there areeight separation layers 382. In the separation stack 334' of FIG. 17, there are six separation layers 382 on the non-absorbent layer 380. In another embodiment, the nonabsorbent layer 380 is larger than the separation layers 382, as shown in the separation stack 334" of FIG. 17, which provides an extension portion 386 for the non-absorbent layer 380. The extension portion 386 in some embodiments is provided both lengthwise and widthwise. In some embodiments, the non-absorbent layer 380 is omitted as shown in the separation stack 334'" of FIG. 19. The various features including the number of separation layers are combined in any desired manner for a particular application. Each of the embodiments are used with the carrier 332. Variations in carrier separation stack thickness is accommodated simply by modification of the height of the stack guides 344 and / or ribs (346 / 350 / 362).

[0081] In each variant, assembly of the sample separation assembly 330 is similarly accomplished by first aligning the separation stack 334 with the stack receiving area 372 as shown in FIG. 20. The separation stack 334 is then inserted into the sample reception area 354 on top of the rib 350. The separation stack 334 is slid across the rib 350 and beneath the first two of the number of stack guides 344 with a tight fit. Sliding insertion continues until the separation stack 334 contacts the rear wall 366 of the base portion 360 as shown in FIG. 21.

[0082] The sample separation assembly 330 is assembled into the reservoir portion 306 to form the capillary sample collection assembly 300 by aligning the sample separation assembly 330 with the reservoir portion 306 as shown in FIG. 22. The rib 350 is then slid onto the sample assembly guide bars 324 as the upper surface 340 and upper surface 342 of the sidewall 338 and sidewall 336 slide along the bottom of the uppersample assembly guide bars 325. Insertion of the sample separation assembly 330 into the reservoir portion 306 continues until the standoff 352 of the nose portion 348 contacts an end wall 388 of the delivery portion 304 as shown in FIG. 23. In this configuration, the uppermost separation layer 382 is positioned directly beneath the mouth 318.Additionally, the sample separation assembly 330 is held in position vertically by contact between the upper surface 340 and upper surface 342 of the sidewall 338 and sidewall 336 slide along the bottom of the upper sample assembly guide bars 325, and by contact between the rib 350, the ribs 346, and the rib 362 on the upper surface of the sample assembly guide bars 324.

[0083] So as to axially fix the sample separation assembly 330 within the reservoir portion 306 the cap 310 is aligned with the reservoir portion 306 as shown in FIG. 23. The cap 310, like the cap 110, includes internal threads 390. Accordingly, the reservoir portion 306 is positioned within the cap 310 and the cap 310 is rotated to threadedly engage the threaded portion 308 with the internal threads 390.

[0084] Unlike the cap 110, the cap 310 includes an alignment guide 392 and a stop 394. As the cap 310 is positioned over the base portion 360, the alignment guide 392 comes into contact with the wall of the reservoir portion 306 which assists in centering the cap 310 on the reservoir portion 306. This further aligns the stop 394 with the tab 364 such that as the cap 310 is rotated the stop 394 abuts the 364 thereby firmly seating the sample separation assembly 330 within the reservoir portion 306 as shown in FIG. 24. In particular, the sample separation assembly 330 is clamped axially by the stop 394 in contact with the tab 364 and the standoff 352 in contact with the end wall 388.

[0085] The capillary sample collection assembly 300 is thus assembled and ready for use to collect and separate a fluid sample such as blood. Like the sample separation assembly 130, the sample separation assembly 330 is typically configured to collect and separate about 250-500 pL of sample. The separation layers 382 in this embodiment are made from Whatman LF-1 material, commercially available from Whatman Inc. of Florham Park, New Jersey. Other suitable material may be used, such as, but not limited to, porous materials that allow liquid and suspended solids to differentially flow and separate based on the molecular size of the molecules. Additionally, the characteristics of the separation layers 362 may be modified by incorporating designs that utilize other physical forces that affect the flow of substances through the separation layers 362. Such physical forces include hydrophobic or hydrophilic interactions as well as ionic interactions. Additionally, temporary hydrogen bonding interactions and gravitational effects may be used to augment or retard flow to provide the desired separation or alteration of a separation of the flowing liquids and suspended cells or other solid materials.

[0086] The non-absorbent layer 380 in some embodiments is made from MYLAR, which is used for its imperviousness to liquid penetration. Other materials which may be used to form an acceptable liquid barrier include thin sheets of Polyethylene, porous UHMWPE film, FEP film, polyester treated sheeting and polypropylene. Another material which provides an acceptable liquid barrier is porous ePTF film, commercially available from DeWai Industries, Inc. of Saunderstown, RI as product number D / W 233MS. The ePTF material is a fluoropolymer material which contains a fluorocarbon material at its surface. The fluorine molecule is the most electronegative element, therebyproviding a desired hydrophobic quality. Specifically, it is believed that the fluorocarbon additive to the base plastic polymer in this material and other fluoropolymers enhances the separation of plasma from the red blood cells in the touching non-absorbent layer 380.

[0087] The coupling portion 302, delivery portion 304, and reservoir portion 306 of the capillary sample collection assembly 300 in one embodiment are made from a polymer or other nonabsorbent / nonreactive material.

[0088] To assemble the sample separation assembly 130 with the sample collection assembly 100, the sample separation assembly 130 is aligned within the sample separation chamber 122. The slot 134 is then positioned within the sample assembly guide slots 124, and the sample separation assembly 130 is slid along the sample assembly guide slots 124 until the sample separation assembly 130 is positioned beneath the mouth 118 and the disrupter bar 120. The plastic plug 132 or cap 110 is then coupled with the reservoir portion 106 to provide a fluid and air-tight connection. In some instances, a protective cover is provided on the coupling portion 102 to keep contaminants from entering into the delivery channel 114.

[0089] To use the sample collection assembly 100 with the assembled sample separation assembly 130, a user positions a collection device on a desired location of the body. One such collection device is the gravity -enhanced fluid collection device of U.S. Patent No. 10,779,757 which issued September 22, 2020. The individual then couples the sample collection assembly 100 to the collection device using the coupling portion 102. The coupling portion 102 is sized to provide an air-tight and fluid tight coupling with the collecting device.

[0090] The collecting device is then operated in the manner appropriate for the device. Typically, this involves operating a plunge button which inserts one or more needles into the individual and then draws a vacuum to withdrawn blood through the punctured skin. The blood then flows, typically due to gravity, into the delivery channel 314 and to the mouth 318. The blood then contacts the uppermost layer of the separation layers 382 which is positioned directly beneath the mouth 318.

[0091] Upon entering the separation layers 382, the sample is wicked by the separation layers 382. As additional fluid is placed into the portion of the separation layers 318 directly beneath the mouth 318, the fluid in the separation layers 382 is further forced along the separation layers 382.

[0092] The amount of fluid that is necessary to obtain the desired amount of fluid component will vary based not only on the materials used, but also based upon the geometry of the channel formed. By way of example, using materials identified above absorbent layers may be formed with a width of from about 0.6 centimeters to about 4 centimeters when separating plasma from a blood sample. Optimum separation of plasma, however, is obtained with a width of about 1 centimeter. By optimizing the separation of the plasma, less blood is needed to obtain a particular amount of plasma.

[0093] The length of the separation layers 382 is also a consideration in ensuring sufficient separation of a sample fluid. By way of example, as the volume of sample fluid deposited in the separation layers 382 increases, the red blood cells, in the case of blood, will travel further along the separation layers 382. Thus, to ensure that a sufficient separation of a sample fluid occurs in the event too much sample is provided, the length of the separation layers 382 may be increased. Typically, the capacity of the separationlayers 382 will be matched to the amount of sample which the collecting device is designed to obtain.

[0094] Once the desired sample has been collected, the separation layers 382 are left to dry. In embodiments incorporating a cap 310, the cap 310 may be removed to reduce drying time.

[0095] The capillary sample collection assembly 300 may then be shipped via any desired mode of transportation to a processing facility. The dried fluid sample contained in the separation layers 382 may be stored for a relatively long time without undue degradation of the sample. Nonetheless, the shelflife of the sample may be extended by placement of the capillary sample collection assembly 300 in a storage container.

[0096] The storage container is preferably a gas impermeable package such as a plastic or foil package. The storage container includes a resealable opening. The resealable opening may include a tamper proof mechanism to provide an indication that the storage container has been opened after a sample has been sealed therein. The storage container is sized to accept the sample collection assembly 100 therein.

[0097] In one embodiment, an oxygen scrubber (not shown) is provided with the storage container. An oxygen scrubber typically includes thin shavings including pieces of metal and a carrier desiccant that loosely holds some amount of water. When the storage container is sealed with an oxygen scrubber therein, oxygen present within the storage container reacts with the metal in the presence of water to form rust, thereby binding the oxygen. Elimination of oxygen from the atmosphere of the storage container provides increased stability for various components within the dried fluid sample. Forexample, lipid analytes such as HDL, cholesterol, and triglycerides may be further stabilized by removal of oxygen from the atmosphere in which the sample is stored.

[0098] If desired, the capillary sample collection assembly 300 may be placed within the storage container and the storage container sealed before a fluid sample within the separation layers 382 has been dried. Sealing the storage container with a wet fluid sample held in the capillary sample collection assembly 300 inhibits drying of the sample.

[0099] When desired, the sample separation assembly 330 is removed from the capillary sample collection assembly 300 to allow for processing of the sample by reversing the assembly order described above. Once the cap 310 is removed, the tab 364 is grasped and pulled to remove the sample separation assembly 330 from the reservoir portion 306.

[0100] In some embodiments, it may be desired for a larger sample to be obtained. While the capacity of the sample separation assembly 330 may simply be increased, more efficient separation of the sample is obtained by providing a dual path capillary sample collection assembly 400 shown in FIG. 25. The capillary sample collection tube 400 is substantially identical to the capillary sample collection assembly 300 but includes two reservoir portions 406. The sample separation assembly (not shown) in some embodiments extends from the left threaded portion 410 to the right threaded portion 410. In other embodiments, two individual sample separation assemblies are provided, with the sample separation assemblies configure to abut directly beneath the mouth as shown in FIG. 26.

[0101] In FIG. 26, the delivery channel 414 directs fluid to the mouth 418 which directs fluid to the upper separation layer 420 of a first sample separation assembly 430. The mouth 418 further directs the fluid to the upper layer 432 of a second sample separation assembly 434. In some embodiments the first sample separation assembly 430 and the second sample separation assembly 434 are sized to abut one another when assembled in the manner described above with respect to the capillary sample collection assembly 300. In other embodiments, the axial positions of the first sample separation assembly 430 and the second sample separation assembly 434 are established using a stop 440 shown in FIG. 26. One or more of the stops 440 in some embodiments is / are mounted to one or more of the sample assembly guide bars 424.

[0102] While the disclosure has been illustrated and described in detail in the drawings and foregoing description, the same should be considered as illustrative and not restrictive in character. It is understood that only the preferred embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the disclosure are desired to be protected. Moreover, various features described above are intended to be used in various combinations within the scope of the disclosure.

Claims

ClaimsWhat is claimed is:

1. A sample collection assembly, comprising:a coupling portion configured to couple with a fluid collection device;a reservoir portion in fluid communication with the coupling portion; and a sample separation assembly slidingly received at least partially within the reservoir portion.

2. The sample collection assembly of claim 1, wherein:the reservoir portion includes at least one sample assembly guide structure; and the sample separation assembly is configured to slide along the at least one sample assembly guide structure to a position whereat a portion of the sample separation assembly is located directly beneath the coupling portion.

3. The sample collection assembly of claim 2, wherein:the coupling portion includes a delivery channel leading downwardly to a mouth; the delivery channel has a first diameter;the mouth has a second diameter;the second diameter is smaller than the first diameter; andthe portion of the sample separation assembly is located directly beneath the mouth.

4. The sample collection assembly of claim 2, wherein the sample separation assembly comprises:a separation stack, the separation stack including a lower non-absorbent layer and a plurality of separation layers located above the lower non-absorbent layer.

5. The sample collection assembly of claim 4, wherein the sample separation assembly comprises:a carrier, the carrier configured to slidingly engage the at least one sample assembly guide structure, and slidingly receive the separation stack.

6. The sample collection assembly of claim 5, wherein the carrier comprises:a first sidewall;a second sidewall; andat least one rib extending between the first sidewall and the second sidewall, whereina first of the at least one rib includes a lower surface configured to slidingly engage the at least one sample assembly guide structure, anda second of the at least one rib includes an upper surface configured to slidingly engage the separation stack.

7. The sample collection assembly of claim 6, wherein:the first of the at least one rib includes an upper surface configured to slidingly engage the separation stack; andthe second of the at least one rib includes a lower surface configured to slidingly engage the at least one sample assembly guide structure.

8. The sample collection assembly of claim 6, wherein the carrier further comprises:at least one stack guide structure extending outwardly from the first sidewall, the at least one stack guide structure configured to slidingly guide insertion of the separation stack within the carrier.

9. The sample collection assembly of claim 8, wherein:the first sidewall includes an upper surface;the reservoir portion includes at least one further sample assembly guide structure; andthe upper surface of the first sidewall is configured to slide along the at least one further sample assembly guide structure to the position whereat the portion of the sample separation assembly is located directly beneath the coupling portion.

10. The sample collection assembly of claim 9, the carrier further comprising:a tab, the tab configured to extend outwardly of the reservoir portion while the portion of the sample separation assembly is located directly beneath the coupling portion.

11. The sample collection assembly of claim 10, further comprising a cap, wherein:the cap is configured to sealingly engage the reservoir portion; andthe cap is configured to clamp the carrier against the reservoir portion by abutment with the tab.

12. The sample collection assembly of claim 11, the carrier further comprising:a nose,whereinthe cap is configured to clamp the nose against the reservoir portion by the abutment with the tab.

13. The sample collection assembly of claim 11, further comprising:a further reservoir portion in fluid communication with the coupling portion; and a further sample separation assembly slidingly received at least partially within the reservoir portion.

14. The sample collection assembly of claim 13, further comprising:a stop located beneath the coupling portion and configured to abut the sample separation assembly and the further sample separation assembly.

15. A method of assembling a sample collection assembly, comprising:providing the coupling portion and the reservoir portion of claim 1; and sliding the sample separation assembly at least partially into the reservoir portion.

16. The method of claim 15, further comprising:sliding the sample separation assembly along at least one sample assembly guide structure to a position whereat a portion of the sample separation assembly is located directly beneath the coupling portion.

17. The method of claim 16, further comprising:forming the sample separation assembly by sliding a separation stack into a carrier, the separation stack including a lower non-absorbent layer and a plurality of separation layers located above the lower non-absorbent layer.

18. The method of claim 17, wherein:sliding the sample separation assembly at least partially into the reservoir portion comprises sliding a lower surface of a first rib of the carrier along at least one sample assembly guide structure;forming the sample separation assembly comprises sliding the separation stack into the carrier by slidingly engaging an upper surface of a second rib of the carrier; the first rib and the second rib extend between a first sidewall of the carrier and a second sidewall of the carrier.

19. The method of claim 18, wherein forming the sample separation assembly comprises:slidingly guiding insertion of the separation stack within the carrier with at least one stack guide structure extending outwardly from the first sidewall, the at least onestack guide structure configured to slidingly engage an upper surface of one of the plurality of separation layers.

20. The method of claim 19, further comprising:clamping the sample separation assembly at least partially within the reservoir portion by abutment of a cap against a tab of the carrier.

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