Capillary blood collection device with reduced platelet adhesion

Abstract

A device for obtaining a blood sample includes a holder for receiving a sample source, a blood collector attachment removably connected to the holder, and a collection container assembly removably connectable to the blood collector attachment. The collection container assembly includes a tube-shaped outer container having an open first end and an open second end, with the first end having a container engagement portion configured to engage the blood collector attachment. The collection container assembly also includes a blood collection reservoir defining a collection cavity for receiving the blood sample and that is separate from the tube-shaped outer container and positioned therein at the first end, and a cap configured to close the first end and seal off the collection cavity of the blood collection reservoir upon disconnecting of the collection container assembly from the blood collector attachment, to retain the blood sample within the collection cavity.

Description

Attorney Docket No. 03896-2506120 (P-30062.W001)CAPILLARY BLOOD COLLECTION DEVICE WITH REDUCED PLATELET ADHESION CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent Application No. 63 / 755,423 entitled “Capillary Blood Collection Device with Reduced Platelet Adhesion” filed February 7, 2025, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to a device for obtaining a biological sample. More particularly, the present disclosure relates to an integrated finger-based capillary blood collection device with the ability to lance and squeeze a finger, collect, stabilize, and dispense a blood sample in a controlled manner, while reducing platelet adhesion in a collection device thereof.Description of Related Art

[0003] Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection that is commonly done in the medial field is capillary blood collection which is often done to collect blood samples for testing. Certain diseases, such as diabetes, require that the patient’s blood be tested on a regular basis to monitor, for example, the patient’s blood sugar levels. Additionally, test kits, such as cholesterol test kits, often require a blood sample for analysis. The blood collection procedure usually involves pricking a finger or other suitable body part in order to obtain the blood sample. Typically, the amount of blood needed for such tests is relatively small and a small puncture wound or incision normally provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed which are used for puncturing the skin of a patient to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available to hospitals, clinics, doctors’ offices, and the like, as well as to individual consumers. Such devices typically include a sharp-pointed member such as a needle, or a sharp-edged member such as a blade, that is used to make a quick puncture wound or incision in the patient’s skin in order to provide a small outflow of blood. It is often physiologically and psychologically difficult for many people to prick their own finger with a hand-held needle or blade. As a result, lancet devices have evolved into automatic devices that puncture or cut the skin of the patient upon the 6983606.DOCX 1Attorney Docket No. 03896-2506120 (P-30062.W001)actuation of a triggering mechanism. In some devices, the needle or blade is kept in a standby position until it is triggered by the user, who may be a medical professional in charge of drawing blood from the patient, or the patient himself or herself. Upon triggering, the needle or blade punctures or cuts the skin of the patient, for example, on the finger. Often, a spring is incorporated into the device to provide the “automatic” force necessary to puncture or cut the skin of the patient.

[0005] One type of contact activated lancet device that features automatic ejection and retraction of the puncturing or cutting element from and into the device is U.S. Patent No.9,380,975, which is owned by Becton, Dickinson and Company, the assignee of the present application. This lancet device includes a housing and a lancet structure having a puncturing element. The lancet structure is disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releases the lever from interference engagement with the lancet structure. The blood sample that is received is then collected and / or tested. This testing can be done by a Point-of-Care (POC) testing device or it can be collected and sent to a testing facility.

[0006] Currently, capillary blood collection workflow is a complex multi-step process requiring high skill level. The multi-step nature of this process introduces several variables that could cause sample quality issues such as hemolysis, inadequate sample stabilization, and micro-clots. The use of lancet devices for obtaining blood samples can result in several variables that effect the collection of the capillary blood sample, including, but not limited to, holding the lancet still during the testing, obtaining sufficient blood flow from the puncture site, adequately collecting the blood, preventing clotting, and the like. Some of the most common sources of process variability are: (1) inadequate lancing site cleaning and first drop removal which can potentially result in a contaminated sample; (2) inconsistent lancing location and depth which could potentially result in insufficient sample volume and a large fraction of interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the lancing site to promote blood extraction (e.g., blood milking) which could potentially result 6983606.DOCX 2Attorney Docket No. 03896-2506120 (P-30062.W001)in a hemolyzed sample; (4) variable transfer interfaces and collection technique which could potentially result in a hemolyzed or contaminated sample; and (5) inadequate sample mixing with an anticoagulant which could potentially result in micro-clots.

[0007] Capillary collection blood draws are typically performed by health care workers either using their fingers to manually squeeze the tissue around the puncture site or by a device using vacuum pressure to pull blood from the site.

[0008] Manually squeezing the collection site is a highly technique dependent process that leads to very large variation in success rate and sample quality (as measured by hemolysis -blood cell rupture). Health care workers typically adjust the pressure and rate at which they squeeze to compensate for patient-dependent differences in blood flow. Squeezing harder helps blood flow more quickly but also increases hemolysis. The location of squeezing also varies between health care workers depending on personal preference, experience, and hand fatigue. Some workers may even perform a process called “milking” of fingers, where they apply pressure starting at the base of the finger and slide towards the tip of finger. This process is discouraged as leading to poor sample quality by domestic and international health organizations.

[0009] Vacuum-powered devices standardize the pressure and technique of blood flow but are typically plagued by poor overall blood flow. The maximum pressure than can be applied is limited by the difference between atmospheric pressure and absolute vacuum (~14 psi), and devices only operate at a fraction of absolute vacuum. For reference, grip strength of men and women range from 50-100 lbs. on average, illustrating why manual methods are instead affected by hemolysis rather than flow. Vacuum methods also apply consistent pressure, limiting the ability of the tissue to replenish with blood.

[0010] Thus, there is a need in the art for a device that has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. There is also a need in the art for a device that simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots. There is still a further need in the art for a closed system collection and transfer that eliminate blood exposure and device reuse. There is still a further need in the art for a device that: (1) introduces flexibility in the accommodation of different capillary blood collection and transfer container; (2) has the capability to generate high quality uniformly mixed / stabilized capillary blood samples; (3) has the capability to generate on-board plasma from capillary plasma samples; (4) has the capability to collect large capillary blood samples (> 50-500pL) at reduced pain; (5) contains 6983606.DOCX 3Attorney Docket No. 03896-2506120 (P-30062.W001)a unique sample identifier that is paired with patient information at the time of collection; (6) has the capability to collect capillary blood and perform on-board diagnostics; and (7) has multiple collection ports to collect a blood sample into different containers having the same or different anticoagulants. There is a further need in the art for a capillary blood collection device that includes a standardized and controlled location of applied pressure, an applied pressure that is high enough for adequate blood flow but below hemolysis thresholds, a defined rhythmic application of pressure rather than consistent pressure to allow blood to replenish in the finger, increasing average blood flow rate, and a reduced user fatigue by lowering maximum applied force by the operator.SUMMARY OF THE INVENTION

[0011] Provided herein is a device for obtaining a blood sample. The device includes a holder for receiving a sample source, with the holder having an actuation portion and a port. The device also includes a blood collector attachment removably connected to the holder and a collection container assembly removably connectable to the blood collector attachment, with the collection container assembly further comprising: a tube-shaped outer container having an open first end comprising a container engagement portion configured to engage the blood collector attachment and an open second end, a blood collection reservoir defining a collection cavity for receiving the blood sample and that is separate from the tube-shaped outer container and positioned therein at the first end, and a cap configured to close the first end of the tubeshaped outer container and seal off the collection cavity of the blood collection reservoir upon disconnecting of the collection container assembly from the blood collector attachment, to retain the blood sample within the collection cavity.

[0012] In some embodiments, the blood collector attachment comprises a post member configured to direct the blood sample from a patient’s finger toward the blood collection reservoir and a guided flow path connected to the post member and configured to further direct the blood sample from the post member to the collection container.

[0013] In some embodiments, a length of the guided flow path is 15.9 mm.

[0014] In some embodiments, the blood collector attachment comprises a coating applied to the guided flow path to prevent adhesion of the blood sample to the guided flow path.

[0015] In some embodiments, the blood collector attachment comprises an anticoagulant applied to the guided flow path to prevent coagulation of the blood sample as it travels along the guided flow path.

[0016] In some embodiments, the blood collection reservoir comprises an upper lip defining an opening into the collection cavity, with the upper lip configured to engage an annular seat 6983606.DOCX 4Attorney Docket No. 03896-2506120 (P-30062.W001)formed on the outer container at the first end, such that the blood collection reservoir is retained at the first end of the outer container.

[0017] In some embodiments, the blood collection reservoir comprises fill lines marked thereof to indicate a volume of the blood sample contained in the collection cavity.

[0018] In some embodiments, the blood collection reservoir comprises an anticoagulant applied to an inner surface thereof to prevent coagulation of the blood sample contained in the collection cavity.

[0019] In some embodiments, the blood collection reservoir is formed from a first material that is different from a second material from which the outer container is formed.

[0020] In some embodiments, the blood collection reservoir comprises a 1.4 mL collection cavity.

[0021] In some embodiments, the cap comprises a hinged cap including a cap body formed integrally with the outer container and connected to the outer container via a hinge that provides for rotation of the hinged cap between an open position and a closed position and a plug retained on the cap body and formed of an elastomeric material configured to effectively seal the blood collection reservoir when the hinged cap is in the closed position.

[0022] In some embodiments, the outer container comprises one or more protrusions thereon that function as a retaining feature by which the collection container assembly may be handled by a sample preparation device.

[0023] In some embodiments, the collection container assembly comprises an extender removably connected to the second end of the outer container, the extender adjusting a bottomoffset of the collection container assembly when coupled to the outer container.

[0024] In some embodiments, the extender is connected to the outer container via a simple axial snap-fit engagement.

[0025] In some embodiments, the collection container assembly comprises a barcode label affixed to the outer container.

[0026] Also provided herein is a collection container assembly for receiving a blood sample from a blood extraction device. The collection container assembly includes a tube-shaped outer container having an open first end and an open second end and a blood collection reservoir separate from the tube-shaped outer container and positioned therein at the first end, the blood collection reservoir defining a collection cavity for receiving the blood sample. The collection container assembly also includes a cap configured to close the first end of the tube-shaped outer container and seal off the collection cavity of the blood collection reservoir upon disconnecting6983606.DOCX 5Attorney Docket No. 03896-2506120 (P-30062.WG01)of the collection container assembly from the blood collector attachment, to retain the blood sample within the collection cavity.

[0027] In some embodiments, the blood collection reservoir comprises an upper lip defining an opening into the collection cavity, with the upper lip configured to engage an annular seat formed on the outer container at the first end, such that the blood collection reservoir is retained at the first end of the outer container.

[0028] In some embodiments, the collection container assembly comprises an extender removably connected to the second end of the outer container, the extender adjusting a bottomoffset of the collection container assembly when coupled to the outer container.

[0029] In some embodiments, the blood collection reservoir includes an anticoagulant applied to an inner surface thereof to prevent coagulation of the blood sample contained in the collection cavity.

[0030] In some embodiments, the outer container comprises one or more protrusions thereon that function as a retaining feature by which the collection container assembly may be handled by a sample preparation device.

[0031] In some embodiments, the blood collection reservoir comprises fill lines marked thereof to indicate a volume of the blood sample contained in the collection cavity.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 is a perspective view of a holder, in accordance with an aspect of the present disclosure;

[0033] FIG. 2 is a perspective view of a device for obtaining a blood sample from a patient’s finger, including the holder of FIG. 1 and a lancet, in accordance with an aspect of the present disclosure;

[0034] FIG. 3 is a perspective view of a device for obtaining a blood sample from a patient’s finger, including the holder of FIG. 1, a blood collector attachment, and a collection container assembly, in accordance with an aspect of the present disclosure;

[0035] FIG. 4 is a perspective cross sectional view of the device, blood collector attachment, and collection container assembly of FIG. 3 when connected;

[0036] FIG. 5 is an exploded view of the blood collector attachment and collection container assembly of FIG. 3;

[0037] FIG. 6 is a detailed view of a blood collection reservoir included in the collection container assembly of FIG. 3, in accordance with an aspect of the present disclosure;6983606.DOCX 6Attorney Docket No. 03896-2506120 (P-30062.WG01)

[0038] FIG. 7 is a detailed view of the collection container assembly of FIG. 3, prior to connection of an extender thereto, in accordance with an aspect of the present disclosure;

[0039] FIG. 8 is a detailed view of the collection container assembly of FIG. 3, with the extender connected thereto, in accordance with an aspect of the present disclosure;

[0040] FIG. 9 is a detailed perspective view of the blood collector attachment of FIG. 3, in accordance with an aspect of the present disclosure;

[0041] FIG. 10 is a first perspective cross sectional view of the blood collector attachment of FIG. 9; and

[0042] FIG. 11 is a second perspective cross sectional view of the blood collector attachment of FIG. 9.DESCRIPTION OF THE INVENTION

[0043] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0044] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0045] The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the needs set forth above and has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots.

[0046] Blood collection is fundamentally driven by pressure-driven flow. Devices or techniques either reduce the pressure outside the blood vessel (vacuum-powered flow) or 6983606.DOCX 7Attorney Docket No. 03896-2506120 (P-30062.WG01)increase the pressure inside the vessels. Both approaches increase the difference between the blood vessel pressure and external pressure, and increase the flow rate from inside the vessel to outside where the collection container is present. The location of squeezing can also be critical, as soft tissues (e.g. fat, skin, and musculature) are perfused with blood while hard tissues and joints are poorly perfused or are too mechanically stable to compress without patient pain.

[0047] Red blood cells (RBCs) are subject to hemolysis during collection. Hemolysis (RBC destruction) contaminates samples for diagnostic analysis, both by spilling cell contents into the liquid serum of the sample and by coloring the serum red via hemoglobin and interfering with colorimetric reactions. The amount of hemolysis during collection is driven by shear-mediated destruction of the cells due to flow rate and flow path as well as pressure-driven hemolysis where physical compression of tissues and vessels can damage cells. Hemolysis can therefore be controlled by ensuring that applied pressures and flows are not too high in any of the locations of the finger being squeezed.

[0048] The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with ability to lance, collect, and stabilize high volume capillary blood sample, e.g., up to or above 500 microliters. The device simplifies and streamlines high volume capillary blood collection by eliminating workflow steps and variabilities which are typically associated with low sample quality including hemolysis, micro-clots, and patient discomfort. The device comprises a retractable lancing mechanism that can lance the finger and an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container. The device also includes a holder that can be cyclically squeezed to stimulate, i.e., pump, blood flow out of the finger and also an anticoagulant deposited in the flow path or collection container to stabilize collected sample.

[0049] Referring to FIGS. 1-3, in an exemplary embodiment, a device 10 of the present disclosure includes discrete components, e.g., a holder 12 (as shown in FIG. 1), a lancet housing or lancet 14 (as shown in FIG. 2), and a collection container assembly 16 and associated blood collector attachment 18 (as shown in FIG. 3).

[0050] Referring to FIG. 1, an exemplary embodiment of a holder 12 of the present disclosure that is able to receive a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 21, is shown and described. A holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 1), an actuation portion 24, a port 26 having a second opening 28, and a finger end guard 30. In one embodiment, the 6983606.DOCX 8Attorney Docket No. 03896-2506120 (P-30062.WG01)finger end guard 30 provides a stop portion for properly aligning and securing a finger 19 within the holder 12. The finger end guard 30 further assists in ensuring the patient’s finger 19 is placed at a proper position within the finger receiving portion 20 so that applied pressure to the patient’s finger 19 will result in adequate blood flow.

[0051] The first opening 22 of the finger receiving portion 20 is configured for receiving a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 21 (shown in FIG. 4). It can be appreciated that the sample source could include other parts of the body capable of fitting within the first opening 22. The port 26 is in communication with the finger receiving portion 20. For example, with a finger 19 received within the holder 12, the port 26 is in communication with a portion of the finger 19. A holder 12 of the present disclosure can be sized to accommodate all finger sizes.

[0052] The second opening 28 of the port 26 is configured for receiving a lancet housing 14 and blood collector attachment 18 (and collection container assembly 16), as described in more detail below. In one embodiment, the port 26 includes a locking portion 32 for securely receiving the lancet housing 14 and the blood collector attachment 18 (and collection container assembly 16) within the port 26.

[0053] In one embodiment, the actuation portion 24 is transitionable between a first position in which the holder 12 defines a first diameter and a second position which the holder 12 defines a second diameter, wherein the second diameter is less than the first diameter. In one embodiment, the actuation portion 24 is transitionable between a first position in which the holder 12 defines a first elliptical shape, and a second position in which the holder 12 defines a second elliptical shape, wherein the first elliptical shape is different than the second elliptical shape. In this manner, with the holder 12 in the second position with a reduced diameter, a portion of the holder 12 contacts the sample source and the actuation portion 24 of the holder 12 is able to pump and / or extract blood 21 as described in more detail below.

[0054] Referring to FIG. 1, in one embodiment, the actuation portion 24 includes a contact member 34. With the actuation portion 24 in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is provided in a first position with respect to a sample source, e.g., the finger 19, such that the contact member 34 may be in slight contact therewith. With the actuation portion 24 in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is provided in a second position with respect to the sample source, e.g., the finger 19, such that the contact member 34 is in an applied pressure contact with the finger 19, and the actuation portion 24 of the holder 12 is able to pump and / or6983606.DOCX 9Attorney Docket No. 03896-2506120 (P-30062.WG01)extract blood 21. For example, with the contact member 34 in the engaged position, the contact member 34 exerts a pressure on the sample source.

[0055] Referring to FIG. 1, in one embodiment, the actuation portion 24 includes a pumping member 36 for applying pressure to the sample source, e.g., the finger 19. In one embodiment, the pumping member 36 comprises a pair of opposed tabs or wings 38. In such an embodiment, each tab 38 may include a contact member 34. In one embodiment, the holder 12 includes a living hinge portion 42. The living hinge portion 42 allows a user to squeeze the wings 38 between a first position (passive state) and a second position (active state). The use of the tabs or wings 38 to draw blood 21 out of a patient’s finger 19 minimizes hemolysis while maintaining an adequate flow of blood from the patient’s finger 19. A resting position and hinge of the wings 38 are designed to maintain contact and retention with the smallest patient finger that can fit into a holder 12 while flexing to accommodate the largest patient finger within a holder 12 without blood occlusion.

[0056] Advantageously, the holder 12 of the present disclosure allows a user to repeatedly squeeze and release the wings 38 to pump and / or extract blood 21 from a finger 19 until a desired amount of blood 21 is filled in a collection container assembly 16. The wings 38 are configured to flex to maintain gentle contact with a range of patient finger sizes that may be used with the holder 12 and to retain the holder 12 on the patient’s finger 19.

[0057] Advantageously, with the holder 12 placed onto a finger 19, the holder 12 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 38 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 12 provides a gentle controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

[0058] Referring still to FIG. 1, in one embodiment, the holder 12 includes a stability extension portion 40. This provides additional support for the holder 12 to be securely placed onto a finger 19. In one embodiment, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for the holder 12 to be securely placed onto a finger 19. The stability extension portion 40 assists in maintaining contact with the patient’s finger 19 during use of the holder 12 while avoiding the blood supply and knuckles of the patient’s finger 19.

[0059] In one embodiment, the finger receiving portion 20 is formed of a flexible material. In some embodiments, the finger receiving portion 20 and the port 26 are formed from a flexible material.6983606.DOCX 10Attorney Docket No. 03896-2506120 (P-30062.WG01)

[0060] Referring to FIG. 2, a device 10 for obtaining a blood sample 21 of the present disclosure includes a lancet housing or lancet 14 that is removably connectable to a port 26 of a holder 12. In one embodiment, the lancet housing 14 includes an inlet or opening 50, an interior 52, a puncturing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the puncturing element 54 is moveable between a pre-actuated position wherein the puncturing element 54 is retained within the interior 52 of the lancet housing 14 and a puncturing position wherein at least a portion of the puncturing element 54 extends through the inlet 50 of the lancet housing 14 to lance a portion of a finger 19.

[0061] In one embodiment, the lancet 14 of the present disclosure is a contact activated lancet and may be constructed in accordance with the features disclosed in U.S. Patent No. 9,380,975, entitled “Contact Activated Lancet Device”, and commonly assigned with the present application, the entire disclosure of which is hereby expressly incorporated herein by reference thereto.

[0062] As indicated above, the lancet housing 14 is removably connectable to the port 26 of the holder 12, with the lancet housing 14 includes an engagement portion 56. Referring still to FIG. 2, in one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12 such that the puncturing element 54 of the lancet housing 14 can be activated to lance or puncture a sample source, e.g., a finger 19. In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container assembly 16 in the port 26.

[0063] To activate the lancet 14, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 of the lancet 14 to lance a finger 19. The lancet 14 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

[0064] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the puncturing element 54 toward the puncturing position. After puncturing, the puncturing element 54 is immediately retracted and safely secured within the interior 52 of the lancet housing 14.

[0065] In one embodiment, the lancet 14 of the present disclosure is used to lance the skin of a finger 19 and then a blood sample 21 is squeezed into a collection container assembly 16 as described in more detail below.6983606.DOCX 11Attorney Docket No. 03896-2506120 (P-30062.WG01)

[0066] In one embodiment, the lancet housing 14 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample 21 flows down a blood flow path at an angle to the lance path as described in more detail below.

[0067] In one embodiment, the lancet 14 includes a hollow needle. In such an embodiment, the lancet housing 14 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample 21 flows along a parallel blood flow path through the hollow needle.

[0068] Referring now to FIGS. 3-11, a device 10 for obtaining a blood sample 21 of the present disclosure includes a collection container assembly 16 and blood collector attachment 18 that are removably connectable to the port 26 of the holder 12. As shown in FIGS. 3-8, the collection container assembly 16 is generally composed of an outer container 64, a cap 66 joined to the outer container 64, a barcode label 68, an extender 70 securable to an end of the outer container 64, and a blood collection reservoir 72 positionable within the outer container 64 and that defines a collection cavity 74 for receiving a blood sample 21. Once a desired amount of blood 21 is collected within the collection container assembly 16, the collection container assembly 16 may be detached from the collection device 10 in order to send a collected sample 21 to a diagnostic instrument and / or testing device. The collection container assembly 16 is sealed via the cap 66 once removed from the collection device 10 to protectively seal the blood sample 21 within the collection cavity 74 of blood collection reservoir 72.

[0069] In one embodiment, the outer container 64 is configured as a tube-shaped member that is open at each of opposing ends thereof. The outer container 64 includes a container engagement portion 76 at a first end 78 thereof and an extender engagement portion 80 at a second end 82 thereof. The container engagement portion 76 is configured to be pushed into engagement with the blood collector attachment 18 such that the outer container 64 of the collection container assembly 16 is secured to the blood collector attachment 18. In this manner, the collection container assembly 16 is securely connected and locked to the blood collector attachment 18 such that a blood sample 21 can safely flow from the finger 19 within the holder 12, through the blood collector attachment 18, and to the collection cavity 74 of the blood collection reservoir 72, as explained in further detail below. The extender engagement portion 80 is configured to receive and mate with the extender 70. In some embodiments, the extender engagement portion 80 may be configured to engage the extender 70 via an axial snap-fit engagement, as explained in greater detail below.6983606.DOCX 12Attorney Docket No. 03896-2506120 (P-30062.W001)

[0070] The outer container 64 is sized so as to accommodate positioning and attachment of the barcode label 68 thereto. The barcode label 68 may include a barcode thereon that associates the blood sample 21 to be collected in collection container assembly 16 to a specific patient.

[0071] In one embodiment, the outer container 64 may include one or more retaining features formed on an external surface thereof that facilitate handling of the collection container assembly 16 by a sample preparation device, after collection of a blood sample 21 therein. In some embodiments, one or more ribs and / or protrusions 84 are provided on outer container 64 that function as retaining features, with the ribs / protrusions 84 providing for handling of the collection container assembly 16 using an existing sample preparation device, such as sample preparation devices from Babson Diagnostics, as a non-limiting example.

[0072] In one embodiment, the cap 66 is configured as a hinged cap that is integrated with the outer container 64 adjacent container engagement portion 76. The hinged cap 66 may be formed as a multi-piece component that comprises a cap body 86 and a plug or septum 88. The cap body 86 may be connected to outer container 64 via a living hinge 90 or other suitable hinge that provides for rotation of the cap body 86 relative to the outer container 64. The plug / septum 88 is retained on the cap body 86 and is formed of an elastomeric material that is configured to effectively seal the collection container assembly 16 (i.e., seal the blood collection reservoir 72) upon collection of a blood sample 21 within the blood collection reservoir 72 - when the hinged cap 66 is moved from an open position to a closed position. In some embodiments, the plug / septum 88 may include a colorant added thereto (e.g., a lavender colorant) to provide for improved visibility of the plug / septum 88 and enable determining of when the plug / septum 88 is positioned appropriately to seal the blood collection reservoir 72.

[0073] The blood collection reservoir 72 is sized and configured to be retained within outer container 64, with the blood collection reservoir 72 being a separate component that may be inserted into the outer container 64 prior to collection of a blood sample 21. The blood collection reservoir 72 may thus have a length, Li, that is less than a length, L2, of the outer container 64, as well as an outer diameter, Di, that is less than an inner diameter, D2, of the outer container 64. As a non-limiting example, the length, Li, of the blood collection reservoir 72 may be 24.6 mm and the length, L2, of the outer container 64 may be approximately 36 mm, while the outer diameter, Di, of the blood collection reservoir 72 may be 8.6 mm and the inner diameter, D2, of the outer container 64 may be 8.9 mm. The blood collection reservoir 72 may comprise an upper lip 92 having an annular configuration, with the upper lip 92 configured to sit within an annular seat 94 formed at the first end 78 of the outer container 64, such that the blood collection reservoir 72 may be held in position relative to the outer container 64 at a 6983606.DOCX 13Attorney Docket No. 03896-2506120 (P-30062.W001)location adjacent the first end 78 thereof. The blood collection reservoir 72 may be retained within the annular seat 94 in a manner that does not interfere with operation of the hinged cap 66. Toward that end, the upper lip 92 further defines an opening 96 of the blood collection reservoir 72 via which a blood sample 21 may be introduced into the blood collection reservoir 72. According to embodiments, the opening 96 is sized to receive the plug / septum 88 of lid 76 therein, such that the blood collection reservoir 72 may be sealed upon collection of the blood sample 21 therein.

[0074] According to embodiments, with the blood collection reservoir 72 formed as a separate component from outer container 64, the blood collection reservoir 72 may be provided as a “customizable” collection reservoir whose collection volume is scalable, so as to provide for collection of a blood sample 21 of desired volume. That is, while a diameter of the blood collection reservoir 72 (and the collection cavity 74 defined thereby) is limited based on positioning of the blood collection reservoir 72 within outer container 64, a length of the blood collection reservoir 72 may be modified to provide a collection cavity 74 of desired volume. According to embodiments, a blood collection reservoir 72 may be selected for inclusion within outer container 64 having a volume of 1.4 mL, or a lesser or greater volume as required based on the sample volume required for a specified test to be performed on the sample. The integration of one of any number of blood collection reservoirs 72 of differing volume into a common collection container assembly 16 thus provides for a collection container assembly 16 with increased flexibility in regards to blood volume collection and testing applications.

[0075] According to embodiments, with the blood collection reservoir 72 formed as a separate component from outer container 64, the blood collection reservoir 72 may be formed from any of a number of suitable materials, including polypropylene or polyethylene terephthalate (PET), as non-limiting examples. Additionally, the blood collection reservoir 72 may be formed to have a desired surface finish, surface texture, secondary-operation coating(s), or multi-layer construction, without compromising the living-hinge requirement needed for the integrated cap 66 on outer container 64.

[0076] According to embodiments, the blood collection reservoir 72 may include fill-lines 98 printed thereon, such as fill-lines 98 that extend circumferentially about the blood collection reservoir 72. As the blood collection reservoir 72 is formed separately from the outer container 64, the fill-lines 98 may be printed directly thereon without interference from the outer container 64, as compared to if the blood collection reservoir 72 were formed integrally with the outer container 64 (where the hinged lid could create an obstacle for printing of such filllines).6983606.DOCX 14Attorney Docket No. 03896-2506120 (P-30062.W001)

[0077] According to embodiments, the blood collection reservoir 72 may include an anticoagulant that is applied (e.g., sprayed) to an inner surface thereof (i.e., within collection cavity 74), in order to help stabilize the blood sample 21 and prevent platelet aggregation, clumping, and formation of micro- clots and / or clots therein. Examples of anticoagulants that may be sprayed onto an inner surface of the blood collection reservoir 72 include ethylenediaminetetraacetic acid (EDTA) and lithium heparin (LiHep), as non-limiting examples. With the blood collection reservoir 72 formed as a separate component from outer container 64, such anticoagulants may be easily applied to the blood collection reservoir 72 and dried / cured, without the possibility of damaging the structural integrity of the outer container 64. That is, as one example, the plug / septum 88, and the colorant therein, may be damaged when exposed to high heat, such as by altering surface properties of the plug / septum 88, which may result in a higher closure force being needed to insert the plug / septum 88 into the opening of blood collection reservoir 72.

[0078] According to embodiments, with the blood collection reservoir 72 formed as a separate component from outer container 64, the blood collection reservoir 72 may be formed (via a molding process) to have any of a number of optimized bottom-geometries, including a spherical-bottom, conical-bottom, flat-bottom, or any other desired reservoir geometry. Such an optimized geometry may be provided for the bottom end of the blood collection reservoir 72 without restriction, as compared to if a collection cavity were integrated into / with the outer container 64, where a bottom geometry of a collection cavity would be limited due to molding limitations (i.e., unfavorable molding conditions due to thick wall sections and / or poor mold flow). Molding of the blood collection reservoir 72 as a separate component also enables the blood collection reservoir 72 to be formed with excellent circularity and controlled geometry, to ensure quality sealing with the plug / septum 88.

[0079] In one embodiment, the extender 70 (or “tube extender”) comprises a component that may be coupled to the extender engagement portion 80 of outer container 64. The extender 70 may be affixed to the outer container 64 after collection of a blood sample in the collection container assembly 16, in preparation for processing / testing of the collection container assembly 16 in an automated hematology instrument. That is, the extender 70 may be affixed to the extender engagement portion 80 of outer container 64 to provide a collection container assembly 16 of a standardized size, with the extender 70 adjusting the bottom-offset of the collection container assembly 16 (i.e., distance between bottom of blood collection reservoir 72 and bottom of extender 70 / collection container assembly 16) to match that of a one-piece, instrument-compatible “microtube for automated process” (MAP) micro-container. In some 6983606.DOCX 15Attorney Docket No. 03896-2506120 (P-30062.WG01)embodiments, the extender 70 may comprise a pair of flexible fingers 100 that provide for a simple axial snap-fit engagement of the extender 70 with the second end 82 of outer container 64. The extender 70 may be coupled to the outer container 64 at a clinical lab (after collection of blood sample 21 in blood collection reservoir 72), to allow automated processing of the collection container assembly 16 in an automated hematology instrument, without requiring a new false-bottom tube aspiration routine. With the extender 70 being a separate component from the outer container 64, the collection container assembly 16 (without the extender 70 thereon) can maintain a bottom form-factor that enables compatibility with existing sample preparation devices, such as sample preparation devices from Babson Diagnostics, as a nonlimiting example. In some embodiments, it is recognized that the extender 70 could be removed from the outer container 64 after testing of a blood sample contained in the collection container assembly 16, so as to enable re-use of the extender 70.

[0080] With continued reference to FIGS. 1-8 and now also referring to FIGS. 9-11, the blood collector attachment 18 of device 10 used in connection with the holder 12 and the collection container assembly 16 is shown and described in more detail. The blood collector attachment 18 is configured to be removably connected to the port 26 of the holder 12 and the container engagement portion 76 of the collection container assembly 16. The blood collector attachment 18 is configured to transfer the blood sample 21 from the patient’s finger 19 to the collection container assembly 16 (i.e., into blood collection reservoir 72). The blood collector attachment 18 relies on gravity, geometric properties, and surface properties to transfer the blood sample 21 from the patient’s finger 19 to the collection container assembly 16.

[0081] The blood collector attachment 18 provides at least two primary functions. First, the blood collector attachment 18 provides a closed system for blood collection that minimizes the exposure of blood to the person or user (e.g., healthcare professionals or patients themselves) collecting the blood sample 21 at the same time minimizing blood exposure to the patient. Second, the blood collector attachment 18 delivers the blood sample 21 from the patient’s finger 19 to the collection container assembly 16 with an improved sample quality.

[0082] In one embodiment of the present disclosure, the blood collector attachment 18 may include a post member 102 that extends from an inner surface of the blood collector attachment 18 towards the port 26 of the holder 12. In one embodiment, the post member 102 is positioned in a cavity 104 defined by the blood collector attachment 18 and is positioned beneath the portion of the patient’s finger 19 from which the blood sample 21 is withdrawn. As shown in FIGS. 4 and 9-11, the post member 102 provided in the blood collector attachment 18 provides a surface for a first drop of blood from the blood sample 21 coming out of the wound in the 6983606.DOCX 16Attorney Docket No. 03896-2506120 (P-30062.W001)patient’s finger 19 to establish a flow path with an inner surface of the blood collector attachment 18. The height / location of the post member 102 may be optimized to ensure the post member 102 does not come in contact with the open wound in the patient’s finger 19 during collection of the blood sample 21 to minimize the risk of infection. At the same time, the position of the post member 102 is close enough to the wound in the patient’s finger 19 to establish contact with the first drop of blood coming out of the wound. An outer wall 106 of the blood collector attachment 18 should be higher than the top end of the post member 102 so the blood sample 21 is directed downwardly after making contact with the post member 102, instead of leaking out of the blood collector attachment 18.

[0083] As shown in FIG. 3, after the first drop of blood comes into contact with the post member 102, a guided flow path 108 provided on an inner surface of the blood collector attachment 18 directs the blood sample 21 to continue to flow down the post member 102 and into the collection container assembly 16 (i.e., into blood collection reservoir 72). The guided flow path 108 minimizes the smearing of the blood sample 21 on the (i.e., into blood collection reservoir 72) and reduces blood hang up in the (i.e., into blood collection reservoir 72). In one embodiment, the guided flow path 108 may extend substantially parallel with a longitudinal axis of the collection container assembly 16. In one embodiment, a curved transition path 110 is provided between the post member 102 and the guided flow path 108. The curved transition path 110 may extend outwardly from the post member 102 towards the guided flow path 108.

[0084] In one embodiment of the present disclosure, several different factors assist in ensuring the blood sample 21 flows along the guided flow path 108 into the collection container assembly 16. The material of the guided flow path 108 or a surfactant applied to the guided flow path 108 may assist in moving the blood sample 21 along the guided flow path 108. Hydrophilic surface properties for the guided flow path 108 may be desirable, which can be achieved through multiple ways such as a hydrophilic material for the guided flow path 108, a copolymer in the guided flow path 108 that provides hydrophilic surface properties, and a surface treatment with chemicals like surfactant that provide blood wicking properties to the surface of the guided flow path 108. Both hydrophobic and hydrophilic materials may help to different levels in minimizing the platelet adhesion to the blood collector attachment 18. Changing the surface properties of the blood collector attachment 18 to extreme hydrophobic and hydrophilic type surface properties may reduce the platelet adhesion to a great extent. A surfactant coating may be used on the blood collector attachment 18 to reduce cell hang up and adhesion of cellular particles to the blood collector attachment surfaces. A lubricant may be used on the surfaces of the blood collector attachment 18 to repel the blood sample 21 from the 6983606.DOCX 17Attorney Docket No. 03896-2506120 (P-30062.WG01)surface of the blood collector attachment 18, thereby reducing cell adhesion and hang up on the surfaces of the blood collector attachment 18. A protein coating, such as BSA (Bovine Serum albumin), may also act as a barrier to cell adhesion on the surfaces of the blood collector attachment 18, thereby reducing platelet adhesion to the surface of blood collector attachment 18.

[0085] Additionally, coating the surfaces of the blood collector attachment 18 with an anticoagulant (e.g., EDTA or LiHep), may introduce the additive sooner to the blood sample 21 and may help stabilize the blood sample 21 faster. This approach may prevent platelet aggregation, clumping and formation of micro clots and / or clots, thereby reducing platelet adhesion to the surface of the blood collector attachment 18.

[0086] In one example, a gravitational force ensures the blood sample 21 continues to run along the guided flow path 108 into the blood collection reservoir 72 of collection container assembly 16. In addition to the gravitational force on the blood sample 21, a surface tension established between the blood sample 21 and the guided flow path 108 assists in routing the blood sample 21 into the collection container assembly 16. The flow phenomenon may be further enhanced by surface modifications. Hydrophilic surface characteristics help improve flow, which may be achieved by using hydrophilic materials or plasma treating the material or coating with additives like surfactants. Geometric features in the blood collector attachment 18 may act as obstacles to guide the flow and restrict the smearing of blood.

[0087] According to embodiments of the disclosure, a length of the blood collector attachment 18 (i.e., of guided flow path 108 therein) is minimized in order to reduce / optimize the surface area that the blood sample 21 travels across through the blood collector attachment 18. In some embodiments, the blood collector attachment 18 may be configured such that a length of the guided flow path 108 formed therein, Lc, is approximately 15.9 mm. This length of the guided flow path 108 is greatly reduced as compared to existing integrated finger-based capillary blood collection device, so as to provide a significant reduction in fluid-path surface-area along which the blood sample 21 travels.

[0088] With continued reference to FIGS. 1-11, use of device 10 for collection of a blood sample 21 will now be described.

[0089] In use of device 10, a desired finger 19 is first cleaned and a holder 12 having an appropriate size for the desired finger 19 is selected and placed onto the finger 19 securely. Next, a lancet housing 14 is connected to the port 26 of the holder 12. As discussed above, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this 6983606.DOCX 18Attorney Docket No. 03896-2506120 (P-30062.W001)manner, the lancet housing 14 is securely connected and locked to the holder 12 such that the puncturing element 54 of the lancet housing 14 can be activated to lance or puncture a sample source, e.g., a finger 19. With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 is in communication with the finger 19.

[0090] When it is desired to activate the lancet 14 to lance the skin of a finger 19, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 of the lancet 14 to lance a finger 19. The lancet 14 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.

[0091] After the finger 19 is lanced to create blood flow 21 from the finger 19, the lancet 14 is removed from the holder 12 and the blood collector attachment 18 and collection container assembly 16 are pushed into the port 26 of the holder 12. A top end of the blood collector attachment 18 is pushed into the port 26 of the holder 12 such that the blood collector attachment 18 is locked within the locking portion 32 of the holder 12, with the collection container assembly 16 in-tum secured to blood collector attachment 18 via connection of the container engagement portion 76 with a bottom end of blood collector attachment 18. In this manner, the blood collector attachment 18 and collection container assembly 16 are securely connected and locked to the holder 12 such that a blood sample 21 can safely flow from the finger 19 within the holder 12 to the blood collection reservoir 72 (i.e., collection cavity 74 therein) of the collection container assembly 16.

[0092] With the collection container assembly 16 properly secured to the holder 12 for collection of a blood sample 21, a user is able to repeatedly squeeze and release the wings 38 of the holder 12 to pump and / or extract blood 21 from a finger 19 until a desired amount of blood 21 is filled in the blood collection reservoir 72 of collection container assembly 16. Advantageously, with the holder 12 placed onto a finger 19, the holder 12 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 38 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 12 provides a gentle controlled finger 19 massage that stimulates blood extraction and minimizes any potential hemolysis.

[0093] For example, in one embodiment, the actuation portion 24 includes a contact member 34. With the actuation portion 24 in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is in the first position with respect to the sample source, e.g., the finger 19. With the actuation portion 24 in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is in the second position and in applied pressure contact with a sample source, e.g., the finger 19, and the actuation portion 24 of the 6983606.DOCX 19Attorney Docket No. 03896-2506120 (P-30062.W001)holder 12 is able to pump and / or extract blood 21. For example, with the contact member 34 in the engaged position, the contact member 34 exerts a pressure on the sample source.

[0094] As blood 21 is extracted out from finger 19 via actuation of holder 12, drop(s) of blood come into contact with the post member 102 of blood collector attachment 18 and are directed down along the guided flow path 108 of the blood collector attachment 18. Blood 21 continues to flow through the guided flow path 108 and into the into blood collection reservoir 72 of collection container assembly 16.

[0095] As previously described, features are provided in the blood collector attachment 18 and collection container assembly 16 to improve the quality of the blood sample 21 that is delivered into the collection container assembly 16. A primary blood sample quality attribute that may be affected by the blood collector attachment 18 and collection container assembly 16 is the platelet count in the blood sample 21. The platelets tend to stick to the surface of the blood collector attachment 18 and collection container assembly 16 and activated platelets coming out of an open wound have a higher tendency to stick to surfaces. Therefore, the blood collector attachment 18 and collection container assembly 16 of the present disclosure are specifically configured to reduce the platelet adhesion on the blood collector attachment 18 surfaces.

[0096] In one embodiment, adhesion of platelets to the blood collector attachment 18 and collection container assembly 16 is reduced by minimizing the surface area-to-blood interaction, with a length of a fluid flow path that the blood travels before reaching the blood collection reservoir 72 being reduced. That is, a length of the guided flow path 108 formed in blood collector attachment 18 may be reduced / minimized - such as to a length of approximately 15.9 mm. to reduce the length of a fluid flow path along which blood 21 travels, thereby also reducing the surface area-to-blood interaction. Additionally, placement / attachment of the blood collection reservoir 72 at the first end 78 of outer container 64 of collection container assembly 16 - immediately adjacent to blood collector attachment 18 - also reduces the length of a fluid flow path along which blood 21 travels, again thereby also reducing the surface area-to-blood interaction.

[0097] In one embodiment, adhesion of platelets to the blood collector attachment 18 is reduced by application of a surfactant to the guided flow path 108 of blood collector attachment 18 that provides blood wicking properties thereto and assists in moving the blood sample 21 along the guided flow path 108. Both hydrophobic and hydrophilic materials may be applied to the guided flow path 108 help to minimize the platelet adhesion to the blood collector attachment 18.6983606.DOCX 20Attorney Docket No. 03896-2506120 (P-30062.W001)

[0098] Finally, quality of the blood sample 21 that is delivered into the collection container assembly 16 may be improved by application of a sample stabilizer, e.g., an anticoagulant, to the guided flow path 108 of blood collector attachment 18 and / or to the collection cavity 74 of blood collection reservoir 72, in order to help stabilize the blood sample 21 and prevent platelet aggregation, clumping, and formation of micro- clots and / or clots therein. Examples of anticoagulants that may be sprayed onto guided flow path 108 and / or to the collection cavity 74 of blood collection reservoir 72 include EDTA and LiHep, as non-limiting examples.

[0099] With reference again to use of device 10, once a desired amount of blood 21 is collected within the blood collection reservoir 72 of collection container assembly 16, the collection container assembly 16 is detached from the blood collector attachment 18 (and holder 12), in order to send a collected sample 21 to a diagnostic instrument and / or testing device. The blood collection reservoir 72 of collection container assembly 16 is sealed via the cap 66 once removed from the collection device 10 to protectively seal the blood sample 21 within the collection cavity 74 of blood collection reservoir 72.

[0100] Upon the collection container assembly 16 being received at a clinical lab, such as for processing / testing in an automated hematology instrument, the extender 70 may be coupled to the outer container 64, such that the collection container assembly 16 mimics a MAP microcontainer that is compatible with a standard automated hematology instrument. Analysis and testing of the blood sample 21 within collection container assembly 16 may then be performed.

[0101] While an embodiment of a capillary blood collection device is shown in the accompanying figures and described hereinabove in detail, other embodiments will be apparent to, and readily made by, those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.6983606.DOCX 21

Claims

Attorney Docket No. 03896-2506120 (P-30062.W001)THE INVENTION CLAIMED IS:

1. A device for obtaining a blood sample, the device comprising:a holder for receiving a sample source, the holder having an actuation portion and a port;a blood collector attachment removably connected to the holder; and a collection container assembly removably connectable to the blood collector attachment, the collection container assembly comprising:a tube-shaped outer container having an open first end and an open second end, the first end comprising a container engagement portion configured to engage the blood collector attachment;a blood collection reservoir separate from the tube- shaped outer container and positioned therein at the first end, the blood collection reservoir defining a collection cavity for receiving the blood sample; anda cap configured to close the first end of the tube-shaped outer container and seal off the collection cavity of the blood collection reservoir upon disconnecting of the collection container assembly from the blood collector attachment, to retain the blood sample within the collection cavity.

2. The device of claim 1, wherein the blood collector attachment comprises:a post member configured to direct the blood sample from a patient’s finger toward the blood collection reservoir; anda guided flow path connected to the post member and configured to further direct the blood sample from the post member to the collection container.

3. The device of claim 2, wherein a length of the guided flow path is 15.9 mm.

4. The device of claim 2, wherein the blood collector attachment comprises a coating applied to the guided flow path to prevent adhesion of the blood sample to the guided flow path.6983606.DOCX 22Attorney Docket No. 03896-2506120 (P-30062.W001)5. The device of claim 2, wherein the blood collector attachment comprises an anticoagulant applied to the guided flow path to prevent coagulation of the blood sample as it travels along the guided flow path.

6. The device of claim 1, wherein the blood collection reservoir comprises an upper lip defining an opening into the collection cavity, with the upper lip configured to engage an annular seat formed on the outer container at the first end, such that the blood collection reservoir is retained at the first end of the outer container.

7. The device of claim 1, wherein the blood collection reservoir comprises fill lines marked thereof to indicate a volume of the blood sample contained in the collection cavity.

8. The device of claim 1, wherein the blood collection reservoir comprises an anticoagulant applied to an inner surface thereof to prevent coagulation of the blood sample contained in the collection cavity.

9. The device of claim 1, wherein the blood collection reservoir is formed from a first material that is different from a second material from which the outer container is formed.

10. The device of claim 1, wherein the blood collection reservoir comprises a 1.4 mL collection cavity.

11. The device of claim 1, wherein the cap comprises a hinged cap including:a cap body formed integrally with the outer container and connected to the outer container via a hinge that provides for rotation of the hinged cap between an open position and a closed position; anda plug retained on the cap body and formed of an elastomeric material configured to effectively seal the blood collection reservoir when the hinged cap is in the closed position.6983606.DOCX 23Attorney Docket No. 03896-2506120 (P-30062.W001)12. The device of claim 1, wherein the outer container comprises one or more protrusions thereon that function as a retaining feature by which the collection container assembly may be handled by a sample preparation device.

13. The device of claim 1, wherein the collection container assembly comprises an extender removably connected to the second end of the outer container, the extender adjusting a bottom-offset of the collection container assembly when coupled to the outer container.

14. The device of claim 13, wherein the extender is connected to the outer container via a simple axial snap-fit engagement.

15. The device of claim 1, wherein the collection container assembly comprises a barcode label affixed to the outer container.

16. A collection container assembly for receiving a blood sample from a blood extraction device, the collection container assembly comprising:a tube-shaped outer container having an open first end and an open second end; a blood collection reservoir separate from the tube- shaped outer container and positioned therein at the first end, the blood collection reservoir defining a collection cavity for receiving the blood sample; anda cap configured to close the first end of the tube-shaped outer container and seal off the collection cavity of the blood collection reservoir upon disconnecting of the collection container assembly from the blood collector attachment, to retain the blood sample within the collection cavity.

17. The collection container assembly of claim 16, wherein the blood collection reservoir comprises an upper lip defining an opening into the collection cavity, with the upper lip configured to engage an annular seat formed on the outer container at the first end, such that the blood collection reservoir is retained at the first end of the outer container.

18. The collection container assembly of claim 16, wherein the collection container assembly comprises an extender removably connected to the second end of the outer6983606.DOCX 24Attorney Docket No. 03896-2506120 (P-30062.W001)container, the extender adjusting a bottom-offset of the collection container assembly when coupled to the outer container.

19. The collection container assembly of claim 16, wherein the blood collection reservoir includes an anticoagulant applied to an inner surface thereof to prevent coagulation of the blood sample contained in the collection cavity.

20. The collection container assembly of claim 16, wherein the outer container comprises one or more protrusions thereon that function as a retaining feature by which the collection container assembly may be handled by a sample preparation device.6983606.DOCX 25

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