Collector accessory for small volume collection container and related sample collection method

Abstract

To provide a collector accessory such as a cap, a closure, a cover, a lid, a seal member or a similar device configured for attachment to an open end of a small volume collection container or an accessory device.SOLUTION: A sample collection accessory device configured for attachment to an open end of a collection container includes a cover and a collector. The cover includes an inner portion configured for insertion into the collection container having a sidewall having an inner surface defining a channel through the accessory device and an outer surface with an outer diameter sized to seal against an inner surface of a sidewall of the container. The cover also includes an outer portion extending radially outward from the inner portion and configured to extend over an end of the sidewall of the collection container. The collector extends distally from the cover and is configured for directing a biological sample to the channel defined by the inner surface of the inner portion of the cover. A method for automated blood sample processing by using a collection container and an accessory device is also provided.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present disclosure relates to a collection accessory or accessory device, such as a cap, closure, cover, lid, sealing member, or similar device, configured to attach to an open end of a small-volume collection container, such as a small-volume collection tube configured to receive a capillary blood sample, including a collector for directing a biological sample obtained from a patient, such as a sample used for medical diagnostic testing, through the open end of the small-volume collection container and into the interior of the small-volume collection container. [Background technology]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 513,362, entitled "Collector Accessory for Small Volume Collection Containers and Related Sample Collection Methods," filed July 13, 2023, the disclosure of which is incorporated by reference in its entirety herein.

[0003] Devices for biological sample collection are commonly used in the medical industry. One common blood collection technique is capillary blood collection to obtain a small blood sample, which can be used for testing to treat and monitor various conditions and diseases. For example, capillary blood samples of diabetic patients are collected periodically to perform blood tests to monitor the patient's blood glucose levels and / or other physiological markers. Test kits, such as cholesterol test kits, also often require the user to obtain a capillary blood sample for analysis.

[0004] The blood collection process to obtain a capillary blood sample typically involves pricking a patient's finger or other suitable body part and allowing the blood sample to be collected in a small volume container. Different types of lancet devices have been developed to puncture a patient's skin to obtain a capillary blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision made by the lancet device usually provides a sufficient amount of blood for these tests. The small volume collection containers used for capillary blood collection are often tubular containers, such as straight walled microtubes. After the sample is collected in the container, the collection container may be sealed by a cap assembly inserted into or onto the open end of the collection container. The sealed container may be provided to a laboratory for processing, such as automated diagnostic testing.

[0005] The automated testing process can include sorting collection containers (e.g., by type, size, and / or contents) using a sorter. Other automated processes can include filling selected specimen collection containers with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, uncapping, aliquoting, and / or automated labeling of the container. Conventional collection containers may not be compatible with any or all of the automated processing machines used to process and analyze collected blood samples. For example, an automated sorter may not be able to sort conventional specimen collection containers (e.g., by type, size, and / or contents) due to unique or irregular shapes of some collection containers, lids, closures, seals, or other components of the components. Thus, there is a need in the art for more universal specimen collection containers having regular shapes that are compatible for use with a wide variety of automated processing machines. The specimen collection containers and assemblies disclosed herein are configured to provide such universal compatibility, meaning that the specimen collection containers can be used with many different automated machines and devices. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Publication No. 2022 / 0280080 [Patent Document 2] U.S. Patent No. 11,399,755 [Patent Document 3] US Patent Application Publication No. 2019 / 0223772 [Patent Document 4] International Publication No. 2020 / 167746 [Patent Document 5] U.S. Patent No. 9,380,975 Summary of the Invention [Problem to be solved by the invention]

[0007] In view of the difficulties of processing conventional sample collection containers using automated systems and devices, the present disclosure is directed to a sample collection container having a simple shape that is compatible with a wide variety of automated devices and systems. In particular, the sample collection containers disclosed herein are desirably compatible with a wide variety of front-end automation devices, automated analyzers, and / or back-end automation devices, thereby providing improved workflow efficiency over conventional manual processing. The present disclosure is also directed to accessory devices or accessories for such blood collection containers that can be used during blood collection and can be removed prior to automated processing of the blood collection container containing the biological sample. Thus, the accessories do not interfere with automated processing devices, such as sorting devices, additive injection devices, centrifuge devices, or quality analysis devices, used to process the biological sample. [Means for solving the problem]

[0008] According to one aspect of the disclosure, a sample collection accessory device configured to attach to an open end of a collection container includes a cover and a collector. The cover includes an inner portion configured for insertion into a collection container having a sidewall with an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against the inner surface of the container sidewall. The cover also includes an outer portion extending radially outward from the inner portion configured to extend over an end of the collection container sidewall. The collector extends distally from the cover and is configured to direct a biological sample into the channel defined by the inner surface of the inner portion of the cover.

[0009] According to another aspect of the disclosure, a collection assembly includes a collection container having an open first end, a second end, and an annular sidewall extending between the first and second ends. The annular sidewall of the collection container defines an internal reservoir configured to receive a biological sample. The assembly also includes an accessory device removably attached to the open first end of the collection container. The accessory device includes a cover and a collector. The cover includes an inner portion inserted into the collection container having a sidewall with an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against the inner surface of the annular sidewall of the collection container. The cover also includes an outer portion extending radially outward from the inner portion and extending over the open first end of the collection container. The collector extends distally from the cover and is configured to direct the biological sample into the internal reservoir of the collection container via a channel defined by the inner surface of the inner portion of the cover.

[0010] According to another aspect of the disclosure, a method for automated blood sample processing includes attaching an accessory device to a collection container by inserting an inner portion of the accessory device through an open first end of the collection container. The accessory device includes a cover and a collector. The cover includes an inner portion including a sidewall having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against the inner surface of the sidewall of the collection container. The cover also includes an outer portion extending radially outward from the inner portion configured to extend over the open first end of the collection container. The collector extends distally from the cover and is configured to direct the blood sample into a channel defined by an inner surface of the inner portion of the cover. The method also includes acquiring a blood sample by passing the blood sample through the collector through a channel defined by the inner portion of the accessory device to an internal reservoir of the collection container. The method also includes removing the accessory device from the open first end of the collection container once the blood sample is acquired and processing the acquired blood sample in the collection container using at least one automated processing device.

[0011] Non-limiting examples of the present invention are now described in the following numbered clauses.

[0012] Clause 1: A sample collection accessory device configured to attach to an open end of a collection container, the sample collection accessory device comprising: (i) an inner portion configured for insertion into the collection container, the inner portion having a sidewall having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against the sidewall of the container; and (ii) an outer portion extending radially outward from the inner portion configured to extend beyond an end of the sidewall of the collection container; and a collector extending distally from the cover configured to direct a biological sample into the channel defined by the inner surface of the inner portion of the cover.

[0013] Clause 2: The accessory device of clause 1, wherein the cover and / or collector comprises a flexible plastic material including one or more of silicone, polypropylene, low density polyethylene, synthetic rubber, or natural rubber.

[0014] Clause 3: The accessory device of clause 2, wherein the flexible plastic material includes an additive to increase the wettability of a surface of the accessory device.

[0015] Clause 4: An accessory device described in any of clauses 1 to 3, wherein the inner portion of the cover is tapered, an outer diameter of a first end of the inner portion is larger than an outer diameter of a second end of the inner portion, and the second end of the inner portion is configured to be inserted into the collection container.

[0016] Clause 5: An accessory device described in any of clauses 1 to 4, wherein the channel defined by the inner surface of the inner portion of the cover is tapered with a diameter at a first end of the channel being wider than a diameter at a lower end of the channel.

[0017] Clause 6: An accessory device described in any of clauses 1 to 5, wherein the outer portion has a first end connected to the first end of the inner portion, a second end, and an annular side wall extending between the first end and the second end of the outer portion.

[0018] Clause 7: The accessory device described in clause 6, wherein an outer surface of the inner portion and an inner surface of the sidewall of the outer portion define an annular slot sized to receive a lip feature extending from the open end of the collection container.

[0019] Clause 8: An accessory device described in any of clauses 1 to 7, wherein the axial length of the inner portion is greater than the axial length of the outer portion.

[0020] Clause 9: An accessory device according to any of clauses 1 to 8, wherein the accessory device and collection container are configured for collection and storage of a capillary blood sample.

[0021] Clause 10: An accessory device described in any of clauses 1 to 9, wherein the collector includes at least one of a scoop, a funnel, or a capillary action member.

[0022] Clause 11: An accessory device described in any of clauses 1 to 10, wherein the collector comprises at least one of a rod, a hollow tube, or a plastic film configured to draw the sample through the accessory device by capillary action.

[0023] Clause 12: An accessory device described in any of clauses 1 to 11, wherein the cover and the collector are an integral part formed by a single molding process, such as injection molding.

[0024] Clause 13: An accessory device described in any of clauses 1 to 12, wherein the collector comprises (i) a first portion connected to and extending from the inner portion of the cover to guide the sample toward the inner portion of the cover, (ii) a second portion opposite the first portion, and (iii) a scoop extending between the first portion and the second portion.

[0025] Clause 14: The accessory device of clause 13, wherein the second portion of the scoop comprises a curved upper edge that is curved in at least two dimensions.

[0026] Clause 15: An accessory device described in any of clauses 1 to 10, wherein the collector comprises a capillary action rod attached to the cover by a wall extending radially between an outer surface of the capillary action rod and the inner surface of the cover.

[0027] Clause 16: The accessory device described in Clause 15, wherein the rod extends through the channel defined by the inner surface of the inner portion of the cover, the rod being hollow including an open first end, an open second end, and an annular sidewall extending between the first end and the second end.

[0028] Clause 17: An accessory device as described in Clause 16, wherein the side wall of the rod defines a narrow channel extending from the first end to the second end of the rod sized for capillary action of the biological sample through the narrow channel.

[0029] Clause 18: An accessory device described in any of clauses 15 to 17, wherein the capillary action rod extends axially in a distal direction beyond a first end of the cover and extends axially in a proximal direction beyond a second end of the cover.

[0030] Clause 19: An accessory device described in any of clauses 1 to 10, wherein the collector comprises a tubular body defining a channel configured to guide the sample to the channel in the cover, and a connector on an outer portion of the collector configured to engage with a corresponding connector of a puncturing device to removably connect the puncturing device to the accessory device.

[0031] Clause 20: An accessory device as described in Clause 19, wherein when engaged with the connector on the outer portion of the collector, the puncture device is positioned over the channel defined by the tubular body to direct the biological sample through the tubular body and cover it within the internal reservoir of the collection container.

[0032] Clause 21: The accessory device described in clause 20, wherein the biological sample travels from the puncture device through the tubular body of the connector and is covered within the internal reservoir of the collection container by gravity.

[0033] Clause 22: An accessory device described in any of clauses 19 to 21, wherein the connector is configured to rotatably engage the puncture device such that the puncture device is movable from a pre-use position, the puncture device is spaced from the open end of the collection container and movable to an in-use position, the puncture device covering the open end of the collection container.

[0034] Clause 23: An accessory device described in any of clauses 19 to 22, wherein the connector comprises a cylindrical member configured to be inserted into a corresponding receiving portion of the puncture device.

[0035] Clause 24: The accessory device described in clause 23, wherein the cylindrical member is held within the receptacle of the sample collection container by a snap-fit ​​connection.

[0036] Clause 25: The accessory device of clause 24, wherein the collector further comprises a latch configured to engage a portion of the puncturing device to maintain the puncturing device in an in-use position, the puncturing device covering the open end of the collection container.

[0037] Clause 26: A collection assembly comprising: a collection container including an open first end, a second end, and an annular sidewall extending between the first end and the second end, the annular sidewall of the collection container defining an internal reservoir configured to receive a biological sample; and an accessory device removably attached to the open first end of the collection container, the accessory device comprising a cover comprising: (i) an inner portion inserted into the collection container, the inner portion having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against an inner surface of the annular sidewall of the collection container; and (ii) an outer portion extending radially outward from the inner portion and extending over the open first end of the collection container; and a collector extending distally from the cover configured to direct the biological sample into the internal reservoir through the channel defined by the inner surface of the inner portion of the cover.

[0038] Clause 27. The collection assembly of clause 26, wherein the collector of the accessory device includes at least one of a scoop, a funnel, or a capillary action member. Clause 28: A collection assembly as described in Clause 26 or Clause 27, wherein the collector of the accessory device comprises (i) a first portion connected to and extending from the inner portion of the cover to guide the sample toward the inner portion of the cover, (ii) a second portion, and (iii) a guide surface extending between the first portion and the second portion.

[0039] Clause 29: A collection assembly as described in Clause 26 or Clause 27, wherein the collector of the accessory device comprises a capillary action rod, the capillary action rod being attached to the cover by a wall extending radially between an outer surface of the capillary action rod and the inner surface of the cover.

[0040] Clause 30: A collection assembly described in any of clauses 26 to 29, wherein the collection container is a microtube having an internal reservoir having a volume of approximately 600 μL to 1000 μL.

[0041] Clause 31: The collection assembly of clause 26, further comprising a blood collection lancing device rotatably attached to the accessory device and configured to rotate about the connector of the accessory device between a pre-use position in which the lancing device is spaced away from the open first end of the collection container and an in-use position in which the lancing device is above the open first end of the collection container.

[0042] Clause 32: The collection assembly of clause 31, wherein the biological sample moves by gravity from the lancing device, through the collector and cover of the accessory device, and into the internal reservoir of the collection container.

[0043] Clause 33: A collection assembly as described in clause 31 or clause 32, wherein the connector comprises a cylindrical member that is inserted into a corresponding receptacle of the puncture device.

[0044] Clause 34: The collection assembly described in clause 33, wherein the cylindrical member is held within the receptacle of the sample collection container by a snap-fit ​​connection.

[0045] Clause 35: A collection assembly as described in Clause 33 or Clause 34, wherein the collector further comprises a latch that engages with a portion of the puncturing device to maintain the puncturing device in the in-use position, the puncturing device covering the open first end of the collection container.

[0046] Clause 36: A collection assembly according to any of clauses 31 to 35, wherein the piercing device comprises a receiving portion sized to receive the connector of the accessory device to secure the piercing device to the cap.

[0047] Clause 37: A collection assembly according to any of clauses 31 to 36, wherein the receiving portion comprises an annular member defining an opening sized to receive the connector of the accessory device.

[0048] Clause 38: A collection assembly described in any of clauses 31 to 37, wherein the puncturing device comprises a holder for receiving a sample source, the holder having an actuation portion and a port, a lancet housing fixed within the port, the lancet housing having an entrance and an interior, and a puncturing element movable between a pre-actuation position in which the puncturing element is held within the interior and a puncturing position in which at least a portion of the puncturing element extends through the entrance.

[0049] Clause 39: A method for automated blood sample processing, comprising the steps of attaching an accessory device to a collection container by inserting an inner portion of the accessory device through an open first end of the collection container, the accessory device comprising: (i) an inner portion having a sidewall having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against an inner surface of a sidewall of the collection container; and (ii) an outer portion extending radially outward from the inner portion configured to extend over the open first end of the collection container; and (iii) an outer portion extending radially outward from the inner portion of the cover. a collector extending distally from the cover configured to direct the blood sample into the channel defined by an interior surface; acquiring the blood sample by directing the blood sample through the collector and into the internal reservoir of the collection container; acquiring the blood sample through the channel defined by the interior portion of the accessory device; removing the accessory device from the open first end of the collection container when the blood sample has been acquired; and processing the acquired blood sample in the collection container using at least one automated processing device.

[0050] Clause 40: The method of clause 39, further comprising, after removing the accessory device from the collection container, placing a cap over the open first end of the collection container to seal the blood sample within the internal reservoir of the collection container prior to processing the blood sample.

[0051] Clause 41: The method of clause 39 or clause 40, wherein the collector of the accessory device comprises at least one of a scoop, a funnel, or a capillary action member.

[0052] Clause 42: A method according to any of clauses 39 to 41, wherein the collector of the accessory device comprises (i) a first portion connected to and extending from the inner portion of the cover to guide the blood sample towards the inner portion of the cover, (ii) a second portion, and (iii) a guide surface extending between the first portion and the second portion.

[0053] Clause 43: A method according to any of clauses 39 to 41, wherein the collector of the accessory device comprises at least one of a rod, a hollow tube, or a plastic film configured to draw the blood sample through the accessory device by capillary action.

[0054] Clause 44: A method according to any of clauses 39 to 43, wherein the step of processing the blood sample in the collection container includes one or more of the following automated testing processes: sorting collection containers containing blood samples by type, size, and / or contents with an automated sorting machine; filling selected sample collection containers with specific additives; centrifugation; vision-based sample quality analysis; serum level analysis; uncapping; aliquoting; and / or automated labeling of collection containers.

[0055] Clause 45: A method as described in any of clauses 39 to 44, wherein the step of obtaining the blood sample includes obtaining a capillary blood sample by puncturing a surface of the patient's skin and drawing the blood sample into the internal reservoir of the collection container using the collector of the accessory device.

[0056] Clause 46: A method according to any of clauses 39 to 41, wherein the collector of the accessory device comprises a tubular body defining a channel configured to guide the blood sample to the channel in the cover, and a connector on an outer portion of the collector configured to engage with a corresponding connector of a puncture device to removably secure the puncture device to the accessory device.

[0057] Clause 47: The method of clause 46, further comprising, after attaching the accessory device to the collection container, attaching the piercing device to the collector by inserting the connector of the collector through a corresponding receptacle of the piercing device.

[0058] Clause 48: The method of clause 47, wherein the puncturing device comprises a holder for receiving a sample source, the holder having an actuation portion and a port, a lancet housing fixed within the port, the lancet housing having an entrance and an interior, and a puncturing element movable between a pre-actuation position in which the puncturing element is held within the interior and a puncturing position in which at least a portion of the puncturing element extends through the entrance.

[0059] Clause 49: The method of clause 47 or clause 48, wherein the connector is rotatably engaged with the receiver via a snap-fit ​​connection.

[0060] Clause 50: The method of any of clauses 47-49, further comprising moving the puncturing device from a pre-use position spaced away from the open first end of the collection container to an in-use position in which the puncturing device covers the open first end of the collection container.

[0061] Clause 51: The method of any of clauses 39 to 50, wherein the collection container includes an open first end, a second end, and an annular sidewall extending between the first end and the second end, the annular sidewall of the collection container defining an internal reservoir configured to receive a blood sample.

[0062] Clause 52: The method of any of clauses 39 to 51, wherein the collection container comprises a microtube, the internal reservoir having a volume of about 600 μL to 1000 μL. [Brief description of the drawings]

[0063] [Figure 1A] FIG. 1A is a perspective view of a sample collection assembly including a sample collection container and an accessory attached to the container, according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B is a cross-sectional perspective view of the top of the sample collection assembly of FIG. 1A. [Figure 1C] FIG. 1C is a cross-sectional exploded view of a portion of the sample collection assembly of FIG. 1A. [Figure 2A] FIG. 2A is a perspective view of another example of a sample collection assembly including a sample collection container and an accessory attached to the container, according to one embodiment of the present disclosure. [Figure 2B] FIG. 2B is a cross-sectional perspective view of the top of the sample collection assembly of FIG. 2A. [Figure 2C] FIG. 2C is a cross-sectional exploded view of a portion of the sample collection assembly of FIG. 2A. [Figure 3A] FIG. 3A is a perspective view of another example of a sample collection assembly including a sample collection container and an accessory attached to the container, according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a perspective view in cross section of a portion of the collection container and accessory of FIG. 3A. [Figure 3C] FIG. 3C is a cross-sectional exploded view of a portion of the sample collection assembly of FIG. 3A. [Figure 4A] 4A is a perspective view of the sample collection assembly and lancing device of FIG. 3A prior to connecting the lancing device to an attachment of the sample collection assembly according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is an exploded perspective view of the collection assembly and lancing device of FIG. A according to one embodiment of the present disclosure. [Figure 4C] FIG. 4C is a perspective view of the collection assembly and lancing device of FIG. 4A, with the lancing device attached to the attachment in an open or pre-use position, according to one embodiment of the present disclosure. [Figure 4D] FIG. 4D is a perspective view of the collection assembly and lancing device of FIG. 4A, with the lancing device attached to the attachment in a closed or in-use position, according to one embodiment of the present disclosure. [Figure 5A] FIG. 5A is an exploded perspective view of a small sample collection container assembly for collecting a biological sample that can be used with an accessory according to one embodiment of the present disclosure. [Figure 5B] FIG. 5B is a cross-sectional view of the sample collection assembly of FIG. 5A in a pre-centrifugation state. [Figure 5C] FIG. 5C is a cross-sectional view of the sample collection assembly of FIG. 5A in a post-centrifugation state. [Figure 5D] FIG. 5D is another cross-sectional view of the capillary collection assembly of FIG. 5A, showing various dimensions of the assembly. [Figure 6A] FIG. 6A is a perspective view of a cap that can be attached to the open top end of the specimen collection container of FIG. 5A according to one embodiment of the present disclosure. [Figure 6B] FIG. 6B is a cross-sectional view of the cap of FIG. 6A. [Figure 7A] FIG. 7A is a perspective view of a sample collection assembly including a lancing device for obtaining a blood sample from a patient's finger according to one embodiment of the present disclosure. [Figure 7B]FIG. 7B is a cross-sectional view of the lancing device of FIG. 7A including a lancet, according to an embodiment of the present disclosure. [Figure 7C] FIG. 7C is a perspective view of a holder of the puncture device of FIG. 7A according to one embodiment of the present disclosure. [Figure 7D] FIG. 7D is a schematic diagram showing a top view of the holder of FIG. 7C connected to a patient's finger to perform a blood collection procedure. [Figure 7E] FIG. 7E is another schematic diagram showing a front view of the holder of FIG. 7C connected to a patient's finger. [Figure 8] FIG. 8 is a flow chart illustrating a method for sample collection and automated processing using low volume sample collection containers and accessories, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0065] For purposes of description hereinafter, the terms "upper," "lower," "right," "left," "vertical," (horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof shall refer to the present invention as oriented in the drawings. The term "proximal" refers to the central or interior portion of a device or object. For example, the "proximal" end of an elongate member may refer to the end of the member connected to the central portion or body of the device. In contrast, the term "distal" refers to the outer portion of a device or object that is spaced away from the central portion or body of the device or object. For example, the "distal" end of an elongate member may refer to the end of the member that is furthest from the body of the device and is not connected to other portions of the device. It is to be understood, however, that the invention may assume alternative variations unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are simply exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0066] The present disclosure relates to a system for collecting biological samples, such as capillary blood samples and other fluid samples, including a biological sample collection assembly 10 and a sample collection container 12 or collection tube for receiving the biological sample. The biological sample may be collected from a patient by a medical professional or practitioner trained to obtain the biological sample, such as a blood sample. The practitioner may be a clinician or health care worker who performs blood collection, fluid delivery, and / or injection procedures for the patient. For example, a "health care worker" may be a medical technician, a phlebotomist, a nurse, or another practitioner trained to perform blood collection procedures according to the sterile practices and protocols of a medical facility. The collection assembly 10 disclosed herein may also include an accessory 28 or accessory device configured to be connected to the sample collection container 12 to introduce or guide the biological sample into the interior of the container 12. The assembly 10, container 12, and accessory 28 disclosed herein may be configured to enable improved blood collection from a puncture site into the interior of the container 12, which may be particularly important for sample collection from difficult to access capillary stick sites, such as a baby's heel stick.

[0067] The accessory 28 of the present disclosure can be used with many different types of sample collection assemblies 10, containers 12, and microtubes known in the art. Examples of sample collection assemblies that can be used with the accessory 28 are disclosed, for example, in U.S. Patent No. 5,399,363, entitled "Small Volume Collection Container," which is incorporated herein by reference in its entirety. In some examples, for example, as shown in FIG. 1A, the sample collection container 12 comprises a body or tube having a first or upper open end 14, a second or lower end 16 that can be closed or open, and an annular sidewall 18 extending therebetween. The open top end 14 can be of an appropriate size and / or shape for collecting a sample from a puncture location, such as a patient's skin surface. As described in further detail herein, in some examples, the open top end 14 can have a flat 360° lip feature 20 (shown in FIGS. 5A-5D) that surrounds the open top end 14 of the container 12. The sample collection container 12 may also include a plug 22 configured to be coupled to the bottom end 14 of the collection container 12 to close the bottom end 14 of the collection container 12 when the bottom end 16 of the container 12 is open. The annular sidewall 18 and / or any interior walls of the collection container 12 may define an interior or internal reservoir 24 of the container 12 sized to contain a sufficient volume of biological sample to perform a diagnostic test. For example, the collection container 12 may be a microtube with the internal reservoir 24 having a volume of about 600 μL to 1000 μL. The collection assembly 10 may also include a cap 26 (shown in FIGS. 5A-6B ) connected to the collection container 12 and configured to close the open top end 14 of the collection container 12 to secure the biological sample within the internal reservoir 24 of the container 12.

[0068] The sample collection container 12 is configured for receipt and storage of biological samples for analysis and testing. As used herein, a "biological sample" may refer to a sample containing one or more biological fluids (e.g., liquid(s), mixture(s), and / or solution(s) obtained from a patient), including, but not limited to, blood (e.g., arterial blood, venous blood, capillary blood, etc.), plasma, saliva, urine, or other fluids obtained from a patient. As used herein, the term "patient" may mean a mammalian organism, and the collection container 10 of the present disclosure may be intended for use in specimen collection procedures performed on humans and / or animals. The collection container 12 may be used for collection, storage, and eventual transport of biological samples for diagnostic testing purposes. For example, the collection container 12 may be configured for use in proteomics, molecular diagnostics, chemical sampling, blood or other bodily fluid collection, coagulation sampling, hematology sampling, and the like.

[0069] In some examples, the collection container 12 and accessories 28 disclosed herein are configured to improve biological sample collection for automation-compatible, low-volume sample collection containers, where the shape of the container is already challenged by design constraints for compatibility with multiple front-end automation and analyzer systems. These constraints can cause the collection container 12 to have a geometry that is not suitable for traditional capillary blood collection, thus determining the need for accessories 28 to improve sample collection. For these reasons, the purpose of the accessories 28 is to improve the ease of biological sample collection for automation-compatible, low-volume collection containers 12, including improved blood flow, elimination of red blood cell hang-ups at the open end of the collection container 12, hemolysis, and other sample quality-related factors that can typically be problematic for capillary blood.

[0070] More specifically, a collection container 12 having a flat open top end 14 or lip mechanism 0 may be generally symmetrical about its longitudinal axis X1. That is, the collection container 12 may be inserted into an automated processing machine in many or all orientations. A collection container 12 with a flat open top end 14 may be used in automated front-end processes used to prepare samples for appropriate analysis, such as automated sorters and other types of automated devices. These devices may include, for example, devices for filling selected specimen collection containers with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, uncapping, aliquoting, and / or automated labeling of containers. The collection container 12 may also be compatible with automated analytical procedures and may house automated diagnostic and / or analytical probes or other specimen extraction devices. The collection container may also be compatible with automated back-end processes employed after the sample has been analyzed, such as resealing, storage, and retrieval.

[0071] In some examples, the collection containers of the present disclosure can be used with different commercially available automated sample analyzers. Examples of such analyzers include, but are not limited to, cobas® P 512, cobas® P 612, cobas® c 501, cobas® c 502, cobas® c 602, cobas® e 601, cobas® e 602, cobas® e 801, and / or cobas® e 802 from Roche Diagnostics, DxA, AU 5800, DCX 700 AU, Dxl, and / or Falcon from Beckman Coulter, Inc., Atellica® SH, Aptio®, Atellica® CH, and / or Atellica® IA from Siemens Healthcare, Vitros® from Ortho Clinical Diagnostics, and / or GLP, a 3600, Alinity, and / or Architect from Abbott.

[0072] The present disclosure also relates to accessories 28 or accessory devices for use with collection container 12 that facilitate or simplify obtaining, collecting, storing, and / or manipulating collected samples. More specifically, accessories 28 of the present disclosure can include a variety of caps, closures, covers, lids, and other sealing members configured to be placed over the open top end 14 of collection container 12. Accessories 28 can include one or more structures that direct the biological sample from a collection location, such as a puncture site on the patient's skin, to the internal reservoir 24 of collection container 12. In some examples, accessories 28 can be disposable devices configured to be attached to the open top end 14 of collection container 12 prior to collection and discarded after collection.

[0073] In some examples, the attachment 28 can include a plastic collection device including a cap portion that connects to the open top end 14 of the collection container 12. The attachment 28 can also include a distally extending collector, such as an extension device, extending from the cap portion configured to direct the biological sample from a sample collection site (e.g., a skin puncture or a vascular access site) into the internal reservoir 24 of the collection container 12. The attachment 28 can also include other mechanical flow directing structures that can be connected to the open top end 14 of the collection container 12, such as glass or plastic capillary action structures (e.g., tubes, rods, etc.) or plastic films attached to the open top end 14 or the interior of the collection container 12 to draw the biological sample toward the internal reservoir 24 of the collection container 14.

[0074] Blood sample collection accessory with scoop The biological sample collector assembly 10 disclosed herein includes a removable sample collection attachment 28 adapted to facilitate sample collection, examples of which are shown in Figures 2A-2C. Additional attachments 128, 228 are shown in Figures 3A-5B. The attachments 28, 128, 228 are removably attached or configured to be attached to the open top end 14 of the collection container 12 during collection of the biological sample. For example, the attachments 28, 128, 228 can include a guide surface or member configured to guide the biological sample from the patient (e.g., from the puncture location) through the attachments 28, 128, 228 and into the interior of the collection container 12. The biological sample can be moved through the attachments 28, 128, 228 by gravity, capillary forces, or other passive or active transport forces to move a small volume of the fluid sample from a first location to a second location. Once the biological sample has been obtained and transferred to the interior of the collection container, the fittings 28, 128, 228 may be removed and the collection container 12 may be capped (e.g., with cap 26 shown in Figures 6A-7C) until the biological sample is ready to be tested.

[0075] As shown in FIGS. 1A-1C, a sample collection attachment 28 of a sample collection assembly 10 including a geometry that facilitates collection of a biological sample (e.g., a capillary blood sample) is configured to be attached to the open top end 14 of a collection container 12. The attachment 28 comprises a cap, cap portion, or cover 30 configured to be positioned over the open top end 14 of the collection container 12. The cover 30 can have a concentric arrangement having an inner annular member or inner portion 32 configured for insertion into the collection container 12 and an outer annular member or outer portion 34 that surrounds the inner portion 32. The inner portion 32 can include a sidewall 36 having an inner surface 38 that defines a fluid channel 40, such as a fluid channel suitable for allowing a collected biological sample to pass through the channel 40 and enter the internal reservoir 24 of the collection container 12 via the attachment 28, and an outer surface 42 having a maximum or maximum outer diameter OD1 (shown in FIGS. 1B and 1C) sized to contact, press against, and / or seal against an inner surface 44 of the sidewall 18 of the collection container 12. 1A-1C, the outer portion 34 of the cover 30 extends over and / or around the open top end 14 of the collection container 12 to prevent fluid from entering or exiting the internal reservoir 24 of the collection container 12, except through a channel 40 defined by the inner portion 32 of the cover 30. The attachment 28 also includes a collector 46 extending distally from the cover 30 that is configured to direct the biological sample into the channel 40 defined by the inner surface 38 of the inner portion 32.

[0076] The cover 32 is generally shaped to direct the flow of the biological sample into the internal reservoir 24 of the collection container 12. For example, as shown in FIGS. 1A-1C, the inner portion 32 of the cover 30 can be tapered (e.g., can have a tapered inner surface 38 and / or outer surface 42). For example, a maximum outer diameter OD1 of a first end or upper end 48 of the inner portion 32 can be greater than an outer diameter OD2 (shown in FIGS. 1B and 1C) of a second end or lower end 50 of the inner portion 32 that is sized to be inserted into the collection container 12. Having a tapered outer surface 42 of the inner portion 32 can facilitate sliding the attachment 28 through the open upper end 14 of the collection container 12. The channel 40 defined by the inner surface 38 of the inner portion 32 of the cover 30 can also be tapered, with an inner diameter ID1 of the upper end 48 of the inner portion 32 being greater than an inner diameter ID2 of the lower end 50 of the inner portion 32. The amount of taper and / or dimensions of the upper end 48 and lower end 50 of the inner portion 32 can be selected to ensure that fluid flows efficiently through the channel 40. In particular, the taper angle may be steep enough to ensure that the biological sample moves through the channel 40 in a controlled manner. However, it is desirable for the lower end 50 of the inner portion 32 to be wide enough to ensure that solid components of the collected biological sample, such as platelets, minerals, and other particles, do not adhere to the inner surface 38 of the inner portion 32 or otherwise block the flow of fluid through the fitting 28.

[0077] The outer portion 34 of the cover 30 may be an annular or tubular structure having a first or upper end 54, an open second or lower end 56 opposite the upper end 54, and a sidewall 58 extending around the inner portion 32 between the upper end 54 and the lower end 56 of the outer portion 34. The upper end 54 of the outer portion 34 may be connected to or integral with the upper end 48 of the inner portion 32. Additionally, as shown in FIGS. 1B and 1C, the outer surface 42 of the inner portion 32 and the inner surface 60 of the outer portion 34 define an annular slot 62 sized to receive the open upper end 14 of the collection container 12. In some instances, contact between the inner surface 60 of the outer portion 34 and / or the outer surface 42 of the inner portion 32 and the collection container 12 may be sufficient to hold the accessory 28 in place and prevent the accessory 28 from sliding out of the collection container 12 at an unexpected or inopportune time. As previously mentioned, the size of the attachment 28 will generally depend on the size of the collection container 12 and / or the automated processing machine with which the collection container will be used.

[0078] The attachment 28 also includes a collector 46 extending distally from the cover 30 configured to direct a collected biological sample into a channel 40 defined by an inner surface 38 of the inner portion 32 of the cover 30. The collector 46 can be any structure configured to direct a biological sample from, for example, a puncture location on the patent's skin (e.g., a skin puncture location) into the channel 40 of the cover 30. For example, the collector 46 can include an angled, arcuate, curved, or tapered surface to direct the biological sample into the channel 40. In other examples, the collector 46 can include a tubular and / or elongated member to direct the fluid sample into the channel 40 and / or the internal reservoir 24 of the collection container 12. In particular, in some examples, the collector 46 may include one or more of a scoop, a wedge, a funnel, and / or a capillary action device (e.g., a rod, a tube, a film, or a similar structure) for directing the biological sample into the channel 40 and / or the internal reservoir 24 of the collection container 12.

[0079] The cover 30 and / or collector 46 may be formed from or include flexible plastic and / or elastomeric materials, such as silicone, polypropylene, low density polyethylene, synthetic rubber (e.g., polychloroprene), natural rubber (e.g., isoprene), as well as stiffer and / or more rigid materials, such as rigid thermoplastic materials, such as acrylonitrile butadiene styrene (ABS), polyester, polycarbonate, polypropylene, high density polyethylene, or polyethylene terephthalate, as well as glass and other ceramic materials. In some examples, the attachment 28 may be a single molded part made by a conventional molding process, such as injection molding. In such examples, the inner portion 32 and the outer portion 34 of the cover 30 may be integral with the collector 56. For example, the guiding surface 64 of the collector 56 may seamlessly extend distally from the inner surface 38 of the inner portion 32 of the cover 30 without gaps, joints, edges, or any other structure that would impede the flow of the biological sample through the attachment 28 to the internal reservoir 24 of the collection container 12. In some examples, the interior surface 38 of the inner portion 32 and / or other surfaces of the appendage 28 may include an additive material to increase the wettability of the surface of the appendage 28. The additive material may be added to the plastic or precursor material used to produce the appendage 28 prior to molding and / or may be applied to the surface of the molded part after molding and / or curing.

[0080] 1A-1C, in some examples, the collector 46 of the attachment 28 is a scoop configured to press against the patient's skin providing a flow path from the skin puncture location, through the attachment 28, and into the internal reservoir 24 of the collection container 12. By using the scoop, the practitioner can effectively obtain a blood sample that allows a sufficient amount of the sample to pass through the attachment 28 and into the collection container 14. In some examples, the collector 46 or scoop can include a first, proximal, or bottom portion 66 connected to and extending from the inner portion 32 to guide the sample toward the channel 40 extending through the inner portion 32 of the cover 30. The collector 46 or scoop also includes a second, distal, or top portion 68 opposite the bottom portion 66. The guide surface 64 is an inwardly facing surface extending between the bottom portion 66 and the top portion 68. The top 68 of the collector 46 or scoop may further comprise a curved upper end that is radially curved about the longitudinal axis X2 of the attachment 28 and about an axis substantially transverse to the longitudinal axis X2 of the attachment 28. The guide surface 64 is provided to direct the biological sample into the channel 40 defined by the inner surface 38 of the inner portion 32. The guide surface 64 may be a curved surface (e.g., a surface that curves in multiple directions) that slopes from the top 68 or upper edge of the collector 46 toward the longitudinal axis of the container 12 and attachment 28. In other examples, the guide surface 64 may be a flat or angled planar surface that does not slope or curve toward a central axis or portion of the guide surface 64.

[0081] As previously mentioned, the attachment 28 is removably inserted into the open top end 14 of the collection container 12. The attachment 28 is shown separated from the collection container 12 in FIG. 1C. To attach the attachment 28 to the open top end of the collection container 12, the practitioner pushes the bottom end 50 of the inner portion 32 of the attachment 28 through the open top end 14 of the collection container 12, as shown by arrow A1 (FIG. 1C), such that the outer surface 42 of the inner portion 32 of the cover 30 contacts the inner surface 44 of the sidewall 18 of the collection container 12. The practitioner then advances the inner portion 32 into the inner reservoir 24 of the collection container 12 until the bottom end 56 of the outer portion 34 contacts the annular ridge 70 or ring extending radially outward from the sidewall 18 of the collection container 12. As previously mentioned, the top end 14 of the collection container 12 slides into the slot 60 defined between the outer surface 42 of the inner portion 32 and the inner surface 60 of the outer portion 34. When the attachment 28 is attached to the collection container 12, a collector 46, such as a scoop, extends distally from a top end 48, 54 of the inner portion 32 or outer portion 34 of the cover 30, as shown in Figures 1A and 1B.

[0082] In contrast to the collection assembly 10 including the removable attachment 28 of the present disclosure, many conventional collection containers or tubes have an open top end with one or more collector structures, such as a scoop, that extend distally from the top lip portion of the collection container or tube. These conventional collectors or scoops are typically integral with and extend distally from the top lip portion of the container or tube. However, containers that include integral scoops may require complex or additional tooling to form the scoop and may be more complicated to manufacture than is required for containers or tubes that have a flat open top end. Containers with integral scoops may also not work well with automated processing machines, as such containers may need to be positioned with the scoop in a specific orientation in order to be recognized and / or operated by the automated machine. For example, the vision systems of some automated machines may only recognize the container when the scoop is in a specific orientation. However, the need to ensure that each container is properly positioned before using the automated machine increases the time and manual labor required to process filled collection containers. Thus, it is believed that the collection assembly 10 including the removable and / or disposable accessories 28 disclosed herein offers substantial advantages in terms of manufacturability and universal automated handling compared to conventional collection assemblies and containers.

[0083] Blood sample collection accessory with capillary actuation device - Patent application 2A-2C show another example of a sample collection assembly 110 including an attachment 128 configured to attach to the open top end 14 of the collection container 12. As with the previous example, the attachment 128 comprises a cover 130 including an inner portion 132 configured for insertion into the internal reservoir 24 of the collection container 12. The inner portion 132 of the cover 130 includes a sidewall 136 having an inner surface 138 that defines a channel 140 through the attachment 128, and an outer surface 142 having an outer diameter sized to seal against the inner surface 44 of the sidewall 18 of the collection container 12. The cover 130 also includes an outer portion 134 that extends over the open top end 14 of the collection container 12.

[0084] The attachment 128 also includes a collector 146 extending distally from the cover 130 configured to direct the biological sample into a channel 140 defined by an inner surface 138 of the inner portion 132 of the cover 130. However, unlike the previous examples, the collector 146 of the attachment 128 of FIGS. 2A-2B is a capillary action device, such as a rod, post, or plastic film, configured to elicit or direct a flow of a biological sample along a surface of the capillary action device for transporting the biological sample, such as a capillary blood sample, from a puncture location in the patient's skin to the internal reservoir 24 of the collection container 12.

[0085] 2B and 2C, the capillary rod or device may be a hollow, elongated tube including an open top 176, an open bottom 178, and an annular sidewall 180 extending between the top 176 and bottom 178. The sidewall 180 of the elongated tube may define a narrow flow passage extending from the top 176 to the bottom 178 of the rod sized for capillary action of a sample through the narrow flow passage.

[0086] As shown in FIGS. 2A-2C, the capillary action rod or device is attached to the cover 130 by a wall 172 extending radially between an outer surface 174 of the capillary action rod or device and an inner surface 138 of the inner portion 132 of the cover 130 such that the rod or device extends through a channel 140 defined by the inner surface 138 of the inner portion 132 of the cover 130. A distal or top end 176 of the rod can extend distally beyond the top end 148 of the cover 130 in a distal direction. Similarly, a proximal or bottom end 178 of the rod can extend beyond the bottom end 150 of the cover 130. For example, an annular sidewall 180 of the rod or device can have an overall length L3. Additionally, the sidewall 180 can extend distally a distance D1 beyond the top end 148 of the cover 130. The rod can also extend proximally a distance D2 beyond the bottom end 150 of the cover 130.

[0087] The attachment 128 of FIGS. 2A-2C is attached to the collection container 12 in a manner similar to the previous examples. Specifically, as shown in FIG. 2C, the attachment 128 is first separated from the collection container 12. When a biological sample is ready to be obtained, the attachment 128 can be attached to the collection container 12 by inserting the inner portion 132 of the cover 130 through the open top end 14 of the collection container 12 in the direction of arrow A2 (shown in FIG. 2C). The cover 130 is then advanced onto the collection container 12 such that the bottom end 156 of the outer portion 134 rests against the annular ridge 70 or ring of the collection container 12 and the open top end 14 of the collection container 12 and moves into the annular slot 162 defined by the outer surface 142 of the inner portion 130 and the inner surface 160 of the outer portion 134 of the cover 130.

[0088] Accessories for blood sample collection and lancing devices 3A-4D show another example of a sample collection assembly 210 including an attachment 228 configured to be removably attached to the open top end 14 of the collection container 12. The attachment 228 is configured to be connected to a lancing device 310 (shown in FIGS. 4A-4D), also referred to as a blood collection device or blood collection assembly. The lancing device 310 includes a holding structure or holder for supporting a finger or another body part (e.g., a patient's finger or toe) and includes or is coupled with a lancet for puncturing the patient's skin surface. The lancing device 310 can also include various surfaces and flow paths for directing the biological sample from the lancing location, for example, to the internal reservoir 24 of the collection container 12. The attachment 228 is shown in proximity to the collection container 12 in FIGS. 3A-3C. The collection container 12, the attachment 228, and the lancing device 310 are shown in FIGS. 4A-4D.

[0089] The attachment 228 may include one or more connectors, latches, locks, or similar mechanical fasteners for engaging the lancing device 310 and thereby securing the lancing device 310 to the attachment 228. When the lancing device 310 is secured to the collection container 12 and the patient's skin is pierced, the biological sample may flow through the guiding surface or channel of the lancing device 310, through the attachment 228, and into the internal reservoir 24 of the collection container 12. The lancing device 310 may be any of a variety of commercially available or custom-made devices for piercing the patient's skin and obtaining a fluid biological sample, including lancets, needles, sharps, or similar devices, as known in the art, which may be adapted to engage with the attachment 228 of the present disclosure. An exemplary lancing device 310, referred to as a capillary collection device, that may be used with the attachments of the present disclosure is shown in FIGS. 4A-4D and 7A-7E. Other lancing or blood collection devices that may be adapted for use with accessory 228 are described in U.S. Pat. No. 5,399,433 entitled "Device for Obtaining a Blood Sample," U.S. Pat. No. 5,499,433 entitled "Apparatus for Attached Flow of Blood," and U.S. Pat. No. 5,499,433 entitled "Capillary Collector with Rotatable Connection," the disclosures of each of which are incorporated herein by reference in their entireties.

[0090] 3A-4D comprises a cover 230 with an inner portion 232 configured for insertion into the collection container 12 and an outer portion 234 that extends over the open top end 14 of the collection container 12. The inner portion 232 includes a sidewall 236 having an inner surface 238 that defines a channel 240 through the attachment 228, and an outer surface 242 having an outer diameter sized to seal against the inner surface 44 of the sidewall 18 of the container 12.

[0091] The attachment 228 also includes a collector 246 extending distally from the cover 230 configured to direct the obtained biological sample into the channel 240 defined by the inner surface 242 of the inner portion 232 of the cover 230. As shown in FIGS. 3A-3C, the collector 246 is an annular or tubular body defining a channel 282 configured to direct the biological sample into the channel 240 extending through the cover 230 or the cover portion of the attachment 228. The tubular body can include a funnel-shaped or tapered inner surface 284 for directing the biological sample into the channel 240 of the cover 230. In some examples, the collector 246 also can include an annular shelf 286, shoulder, ridge, or similar support surface on the inner surface 284 of the collector configured to align with and support a corresponding outlet or outlet of the piercing device 310 such that the biological sample flows directly from the piercing device 310 into the channel 240 defined by the inner portion 232 of the cover 230. As shown most clearly in Figures 3B and 3C, the collector 246 may also include an outer shelf 288 or shoulder portion on the exterior of the collector 246 configured to receive corresponding structure of the puncture device 310 to support the puncture device 310 when the collector 246 is attached to the attachment 228.

[0092] The collector 246 of the attachment 228 may also include a connector 290 extending from a portion of the collector 246 configured to engage with a corresponding receiver 312 (shown in FIGS. 4A-4D) of the piercing device 310 to secure the piercing device 310 to the attachment 228. Upon engaging the connector 246, the piercing device 310 is positioned over the channel 240 defined by the inner portion 232 of the cover 230, meaning that the sample passes from an outlet or port of the piercing device 310 to the channel 240. The biological sample then passes through the channel 240 of the cover 230 and into the internal reservoir 24 of the collection tube 12. In particular, the piercing device 310 and the attachment 228 may be configured such that the acquired biological sample flows by gravity through the channel 282 of the collector 246 and the channel 240 of the cover 230 into the internal reservoir 24 of the collection container 12.

[0093] In some examples, the connector 290 can be a protruding member, such as a post, protrusion, or cylindrical member extending from an outer surface of the collector 246. The protruding member can be configured to be received within and / or inserted into a corresponding receiver 312, such as an annular ring or circular opening (shown in FIGS. 4A-4D ), of the puncture device 310 to removably secure the puncture device 310 to the attachment 228. The connector 290 can include a rib, lip, protrusion, ridge, or similar raised portion extending around an outer surface of the connector 290 such that the connector 290 forms a snap-fit ​​connection with the receiver 312 of the puncture device 310.

[0094] In some examples, the connector 290 is configured to rotatably engage with the lancing device 310. For example, the connector 290 can be shaped to allow the receiver 312 of the lancing device 310 to rotate around the connector 290 in a clockwise and / or counterclockwise connection. The lancing device 310 can be configured to rotate in the direction of arrow A3 (shown in FIGS. 4B and 4C ) from a pre-use position (shown in FIG. 4C ) in which the outlet port of the lancing device 310 is away from the channel 282 of the collector 246, to a use position (shown in FIG. 4D ) in which the outlet port of the lancing device 310 is connected to or covers an opening to the channel 282 of the collector 246. For example, the practitioner may rotate the lancing device 310 toward the opening to the channel 282 when ready to perform the skin lancing and obtain a biological sample. To access the internal reservoir 24 of the collection container 12, the practitioner may rotate the puncture device 310 in the opposite direction which moves the outlet port of the puncture device 310 away from the channel 282. Advantageously, the rotatable connection between the puncture device 310 and the collector 246 means that the practitioner can access the internal reservoir 24 of the collection container 12 without having to disconnect the puncture device 310 from the attachment 228.

[0095] In some examples, the attachment 228 further comprises a latch 292 configured to engage a portion of the lancing device 310 to maintain the lancing device 310 in the use position shown in FIG. 4D (i.e., a position in which the biological sample passes from the lancing device 310 to the channel 282 defined by the collector 246 of the cover 230). For example, the latch 292 can be a protrusion, such as a square or rectangular protrusion, extending from an outer surface of the collector 246 on a side of the collector 246 opposite the connector 290. As shown in FIGS. 4A-4D, the lancing device 310 includes a corresponding latch receiver 314, such as a square or rectangular ring or opening, configured to receive the latch 292 to lock the lancing device 310 in the use position.

[0096] The attachment 228 of FIGS. 3A-4D is attached to the open top end 14 of the collection container 12 in the same manner as in the previous examples. Specifically, as shown in FIG. 3C, the attachment 228 can be initially provided separate from the collection container 12. When a sample is ready to be collected, the attachment 228 can be attached to the collection container 12 by inserting the inner portion 232 of the cover 230 through the open top end 14 of the collection container 12, as shown by arrow A4 in FIG. 3C. The cover 230 is then advanced over the collection container 12, with the bottom end 256 of the outer portion 234 resting against the annular ridge 70 or ring of the collection container 12, such that the open top end 14 of the collection container 12 is received within the annular slot 262 defined by the outer surface 242 of the inner portion 230 and the inner surface 260 of the outer portion 234 of the cover 230. Once the attachment 228 is attached to the collection container 12, the piercing device 310 is attached to the attachment 228 by inserting the connector 290 or a protruding member of the attachment 228 through the receiver 312 of the piercing device 310, as shown by arrow A5 (shown in FIG. 4B), thereby releasably engaging the piercing device 310 to the attachment 228. Once the piercing device 10 is attached to the attachment 228, the piercing device 310 can be moved from a pre-use position (shown in FIG. 4C) to a use position (shown in FIG. 4D) by rotating the receiver 312 about the connector 290, as shown by arrow A3 (FIGS. 4B and 4C), thereby moving the piercing device 310 up the channel 282 of the collector 246 and engaging the latch receiver 314 of the piercing device 310 with the latch 292 of the collector 246.

[0097] Capillary sample collection container As previously mentioned, the accessory devices or accessories 28, 128, 228 disclosed herein are configured to be connected to a variety of different shapes and configurations of collection containers, including, for example, but not limited to, the collection container 12 shown in Figures 1A-4D. The accessories 28, 128, 228 can also be connected to different types of collection containers, including collection containers of various shapes, lengths, and material compositions. After describing the features of the exemplary accessories 28, 128, 228 in detail, additional features of the sample collection assembly 10, including the collection container 12 and the cap 26, will be described with reference to Figures 5A-5D. Specifically, these figures show the sample collection assembly 10 comprising the collection container 12, also referred to as a collection tube, for collecting a biological sample, and the cap 26 configured to attach to the open top end 14 of the container 12 to seal the biological sample acquired within the internal reservoir 24 of the collection container 12. For example, after a biological sample has been obtained, a practitioner may remove the attachment 28, 128, 228 from the open top end 14 of the collection container 12 and attach the cap 26 to the open top end 4 of the container 12 to store and / or preserve the biological sample contained therein. However, it will be understood that the components of the collection assembly 10 and collection container 12 shown in Figures 5A-5D are merely exemplary, and that many other types and configurations of collection containers may also be used with the accessory devices or attachments 28, 128, 228 of the present disclosure.

[0098] As previously described and shown in FIGS. 5A-5D, the collection container 12 includes a body or tube having an open top end 14, a second or bottom end 16, and an annular sidewall 18 extending therebetween. The open top end 14 can be of an appropriate size and / or shape for collecting a sample from a puncture location, such as a patient's skin surface. In some examples, the open top end 14 can have a flat 360° lip feature 20 that surrounds the open top end 14 of the container 12. The sample collection container 12 can also include a plug 22 configured to be coupled to the bottom end 16 of the collection container 12 to close the bottom end 16 of the collection container 12 when the bottom end 16 of the container 12 is open. The annular sidewall 18 and / or any interior walls of the collection container 12 can define an interior or internal reservoir 24 of the container 12 sized to contain a sufficient volume of biological sample to perform a diagnostic test. For example, the internal reservoir 24 can have a volume of about 600 μL to about 1000 μL.

[0099] In some examples, the collection container 12 is a microtube suitable for capillary collection of a blood sample having overall exterior dimensions that fit into a standard tube (e.g., 13 mm x 90 mm) so as to be compatible with standard testing equipment and / or automated processes. The collection container 12 can be formed by a suitable molding process, such as injection molding, from a suitable plastic or composite material, such as a rigid or semi-rigid material (e.g., polypropylene). The collection container 12 can also include a fill line that corresponds to the volume of the biological sample contained within the collection container 12.

[0100] In some examples, the collection container 12 is configured to be compatible with most existing tube type identification and recognition systems, such as those that include a vision / camera system that can be configured to read the unique tube exterior profile, thereby allowing the tubes to be properly recognized and sorted for further analytical processing.

[0101] In some examples, the internal reservoir 24 of the collection container 12 can have an overall height-to-diameter ratio that creates a taller column of blood or specimen within the collection container 12, even when the volume of collected blood or specimen is relatively small (e.g., 800 μL or less), as compared to a conventional container having an internal reservoir with a constant diameter and straight walls.

[0102] In some examples, the collection container 12 includes an open lip portion 20 that is uniform along its entire circumference, meaning that the lip portion 20 does not include scoops, ridges, protrusions, or other extensions found on many conventional collection containers. Specifically, the open lip portion 20 may be substantially planar around the entire 360° circumference of the open top end 14 of the collection container 12. Additionally, the open lip portion 20 may be planar such that a plane passing through the lip portion intersects the longitudinal axis X1 of the collection container 12. A uniform open lip portion 20 avoids the shortcomings of conventional collection tubes, where the extensions or collector portions that extend distally from the top of the container may not be compatible with automated processing machines. Notably, as previously discussed, a collection container 12 having a uniform lip portion 20 has the same appearance regardless of orientation. Thus, the collection container 12 has an outer shape that can be more easily identified by a vision / camera system regardless of how the collection container 12 is stored or oriented.

[0103] As shown in FIGS. 5A-5E and 6A and 6B, the assembly 10 can also include a cap 26 configured to be attached to the collection container 12 to cover and seal the collection container 12 and any sample contained therein. The cap 26 can be removably attached to the collection container 12 after collecting the sample contained therein and removing the attachments 28, 128, 228 from the open top end 14 of the container. In some examples, the cap 26 can be made from a mixture of a rigid or semi-rigid material and a flexible material, such as a thermoplastic elastomer. Further, in some examples, the material and / or shape of the cap 26 can be selected to allow for one-handed closure and initial sealing of the collection container 12, meaning that the cap 26 can be easily closed with little or no force required. The cap 26 should also provide a high sealing pressure during centrifugation to prevent leakage. In some examples, the centrifugation process can be a reverse centrifugation process, where the collection container 12 is inserted into a centrifuge in an upside-down orientation (i.e., with the lid of the collection container 12 disposed at the bottom of a receptacle receiving cavity or well of the centrifuge). Thus, the cap 26 can be designed to withstand the forces exerted on the lid during reverse centrifugation. In some examples, a latch (not shown) is provided to secure the cap 26 in a closed position during storage, shipping, and handling of the collection container 12.

[0104] In some examples, the capillary collection container assembly 10 further comprises a bottom plug 22. The bottom plug 22 can be configured to be coupled to the collection container 12 to effectively close the open bottom 16 of the container 12. In this manner, the collection container 12 has or defines a closed lower internal reservoir or bottom cavity 74, which means that the collection container 12 can be used with existing automated racks and carriers. The bottom plug 22 can be configured to make a press-fit interference connection to the collection tube 12 within the open bottom end 16 of the collection container 12.

[0105] 5B and 5C are cross-sectional views of the collection container assembly 10 in both a pre-centrifugation state (FIG. 5B) and a post-centrifugation state (FIG. 5C). As shown in FIGS. 5B and 5C, the cap 26 is configured to be coupled to the collection container 12 around the open top end 14 of the container 12 to effectively close and seal the internal reservoir 24. More specifically, in some examples, the top of the collection container 12 can define the internal reservoir 24 for the collection, storage, and ultimate transfer of the biological sample. The internal reservoir 24 can extend from the open top end 14 of the container 12 to a rounded bottom 72 of the collection container 12. The rounded bottom 72 can be an interior wall extending inwardly from the inner surface 44 of the sidewall 18 of the container 12 that defines the bottom of the internal reservoir 24. In some examples, the internal reservoir 24 may be coated with one or more additives (e.g., clot activators, lithium heparin, hemorepellancy additives, etc.) that may be sprayed or injected into the collection container 12 to preserve the blood or specimen sample contained within the collection container 12 during storage, or for other diagnostic purposes as known to those of skill in the art.

[0106] 5B and 5C, the internal reservoir 24 is defined within the sidewall 18 of the container 12, which has a generally angled, rounded profile terminating in a rounded bottom 72. The angled and rounded profile of the internal reservoir 24 can be configured to allow for an overall increased height-to-diameter ratio to create a taller column of blood or sample within the collection container 16, thereby providing better visualization and / or simplified collection of the sample collected within the internal reservoir 24, as well as reduced "dead volume" and compatibility with sample volume detection systems, as compared to containers having a reservoir that extends completely from the top 14 to the bottom 16 and is defined by the inner surface 44 of the sidewall 28 of the container 12. For example, the inner surface 44 can be angled between 2.5° and 10° relative to the longitudinal axis X1 of the collection container 12, thereby providing a taller specimen column compared to a tube having an internal reservoir with non-sloped (or minimally sloped) sidewalls.

[0107] In some examples, the lower portion of the collection container 12 includes a generally hollow or "false" bottom cavity 74 defined by the sidewalls 18 of the container 12, the bottom 16 of the container 12, and the rounded bottom 72 of the collection container 12. The "false" bottom cavity 74 in the lower portion of the collection container 12 can aid in the injection molding of the collection container 12 by promoting plastic flow. Additionally, by extending the lower portion of the collection container 12 in this manner, and by providing a bottom plug 22 at the lower end 16 of the container 12, the collection assembly 10 can be more readily compatible with standard medical testing equipment and / or automated processes.

[0108] As mentioned above, FIG. 5B shows the collection container 12 in a pre-centrifugation state. In such a state, the internal reservoir 24 may include a gel separator material 76 at its bottom, and a specimen sample 78 (e.g., a blood sample) having an overall lower density than the gel separator material 76 is maintained above the gel separator material 76. Upon centrifugation, the collection container 12 separates the primary components of blood (e.g., plasma / serum and hematocrit, which is primarily comprised of red blood cells) by density, with the higher density hematocrit settling to the bottom of the internal reservoir 24 and the lower density plasma / serum collecting above the hematocrit. Meanwhile, the gel separator material 76 is configured to have a density between the plasma / serum and the hematocrit. Thus, upon centrifugation, the gel separator material 76 forms a barrier between the plasma / serum and the hematocrit.

[0109] FIG. 5C shows the collection container 12 in a post-centrifugation state. In FIG. 5C, the specimen sample 78 has been separated into two major component portions, specifically, a plasma / serum portion 80 and a hematocrit portion 82. Also, after centrifugation, the gel separation material 76 has migrated from the bottom of the internal reservoir 24 to create an effective barrier between the plasma / serum portion 80 and the hematocrit portion 82. Due to the reduced overall size of the internal reservoir 24 relative to the overall size of the collection container 12, the plasma / serum portion 80 of the specimen sample 78 is readily visible to the user and accessible for analyzer / probe aspiration, even when the volume of collected capillary blood is relatively low.

[0110] Figure 5D and Table 1 show dimensions of the collection canister 12 and cap 26 of the collection canister assembly 10. However, it should be understood that the dimensions shown in Figure 5D and Table 1 and described herein are merely exemplary, and that the collection canister assembly 10 is not limited to such dimensions or ranges of dimensions.

[0111] [Table 1]

[0112] As is evident from the dimensions shown and described with respect to FIG. 5D and Table 1, the overall length of internal reservoir 24 (C) is much smaller than the overall length of collection container 12 (B), thereby enabling collection container 12 to handle small specimen volumes, while maintaining a conventional form factor for use with standard medical testing equipment and / or automated processes. Additionally, because collection container bottom inner diameter (F) is significantly smaller than collection container opening inner diameter (D), tapered sidewall 18 provides a taller column of blood or specimen, allowing for improved specimen visibility, specimen collection, and / or barrier separation between specimen components.

[0113] 6A and 6B are close-up views of the cap 26, which may be connected to the open top end 14 of the collection container 12 after the attachment 28 has been removed from the collection container 12. The cap 26 is configured to be substantially cylindrical in shape, with a bottom annular portion 84 defining an opening 86, and an upper annular surface 88. Extending between the upper annular surface 88 and the bottom annular portion 84 are a plurality of vertically extending ribs 90. The ribs 90 may extend 360° around the cap 26, facilitating gripping and removal of the cap during automated processing, as compared to conventional caps having a generally cylindrical shape and / or rib arrangement that extends less than 360° around the cap. Within the upper annular surface 88, the cap 26 may include a cavity portion 92 (shown in FIG. 6B) defined by a sidewall. The hollow portion 92 and sidewalls may be sized and configured to fit within the inner diameter of the open top end 14 of the collection container 12, thereby effectively closing / sealing the open top end 14 when the cap 26 is placed on the collection container 12.

[0114] Additionally, adjacent the bottom annular portion 84, the cap 26 may further include a downwardly extending sidewall portion 94 (shown in FIG. 6B ), which creates a gap between the bottom annular portion 84 and the sidewall portion 94. Although not shown, the cap 26 may be held in place on the collection container 12 via snap grooves on the cap 26 and / or the collection container 12, which provide audible and / or tactile feedback to the user to confirm that the cap 26 is secured to the collection container 12. Additionally, the seat portion of the cap 26 may effectively seal the contents of the internal reservoir 24 within the collection container 12. Although the interface between the cap 26 and the collection container 12 is described herein as a snap fit, it should be understood that the cap 26 and / or the collection container 12 may be coupled by any suitable method, such as, for example, a threaded interface, a bayonet interface, or the like.

[0115] Specimen collection assembly and lancing device As previously discussed, the attachment 228 of Figures 3A-4D may be configured to engage a variety of different types of lancing or sample collection devices, such as lancets, sharps, needles, and devices that include a sharp elongated member for skin lancing. With reference now to Figures 7A-7E, additional features of an exemplary lancing device 310 that may be used with the attachment 228 will be described in detail. However, it will be understood that other types of lancing and sample collection devices may also be used with the attachments of the present disclosure. For example, a particular lancing and sample collection device may be modified to include various connectors, receptacles, latches, and other mechanisms for attaching the device to the attachment 228 described above and similar devices.

[0116] 7A-7E, blood sampling device 310 can be, for example, a complete, fully integrated finger-based peripheral blood collection device capable of lancing, collecting, and stabilizing a high volume peripheral blood sample, for example, up to 500 microliters or more, in sample collection container 12. Lancing device 310 can also be formed from separable components (e.g., a finger cuff and a lancet) that can be connected and / or used together to obtain a blood sample.

[0117] 7A and 7B, the lancing device 310 includes an integrated holder 30 and a lancet housing or lancet 304 (shown in FIG. 7B) for lancing a patient's finger 319 (shown in FIGS. 7A, 7D, and 7E). In other examples, the lancet housing 304 can be separate from the holder 12. The holder 302 is configured to receive a sample source, e.g., a patient's finger 19, for providing a biological sample, such as a blood sample. The holder 302 generally includes a finger receiving portion 320 having a first opening 322, an actuation portion 324, a port 326 having a second opening 328, and a finger end guard 330. In some examples, the finger end guard 330 provides a stop for proper adjustment and securing of the finger 319 within the holder 302. The finger end guard 330 further helps ensure that the patient's finger 319 is properly positioned within the finger receiving portion 320 so that pressure applied to the patient's finger 319 results in proper blood flow. The finger end guard 330 can have a curved fingertip rest that ensures that the patient's finger 319 rests at the end of the finger receiving portion 320 while allowing the patient's fingernail to leave without touching the end of the finger receiving portion 320. The finger receiving portion 320 allows for the use of the holder 312 for artificial and natural fingernail styles present in the patient population.

[0118] The first opening 322 of the finger receiving portion 320 is configured to receive a sample source, for example, a finger 319. The sample source may also include other parts of the body that can fit within the first opening 322, such as a toe or other extremity. The port 326 is in communication with the finger receiving portion 320. For example, with the finger 319 received within the holder 302, the port 326 is in communication with a portion of the finger 319. The second opening 328 of the port 326 is configured to receive a lancet housing or lancet 304 (shown in FIG. 7B ) and a collector 246 of the attachment 228 to establish fluid communication between the port 326 and the internal reservoir 24 of the collection container 12. In some examples, the port 326 further includes a locking portion 332 for securely receiving the lancet housing or lancet 304 and the collector 246 of the attachment 228 within the port 326.

[0119] The actuating portion 324 of the lancing device 310 is transitionable between a first position in which the holder 302 defines a first diameter and a second position in which the holder 302 defines a second diameter, the second diameter being less than the first diameter. Further, in the first position, the holder 302 defines a first elliptical shape. 302 defines a second elliptical shape, the first elliptical shape being different from the second elliptical shape. In this manner, when the holder 302 is in the second position having a reduced diameter, a portion of the holder 302 contacts a sample source (e.g., finger 319) and the actuating portion 324 of the holder 302 can push and / or extract blood.

[0120] In some examples, the actuating portion 324 includes a contact member 334. With the actuating portion 324 in a first position, the contact member 334 is in a disengaged position, i.e., the contact member 334 is provided in a first position relative to the sample source, and the contact member 334 may be in slight contact therewith. With the actuating portion 324 in a second position, the contact member 334 is in an engaged position, i.e., the contact member 334 is brought to a second position relative to the finger 319 such that the contact member 334 is in applied pressure contact with the finger 319, and the actuating portion 324 of the holder 302 may push and / or extract blood. For example, when the contact member 334 is in the engaged position, the contact member 334 applies pressure to the sample source.

[0121] In some examples, the actuation portion 324 includes a pump member 336 for applying pressure to the finger 319, such as a pair of opposing tabs or wings 338. Each wing 338 can include a contact member 334. The holder 302 can also include a living hinge portion 342. The living hinge portion 342 allows the practitioner or patient to squeeze the wings 38 between a first position (passive state) and a second position (active state). The use of the tabs or wings 338 to draw blood from the patient's finger 319 is believed to minimize hemolysis while maintaining adequate blood flow from the patient's finger 319. The resting position and hinge of the wings 38 are designed to flex to accommodate the patient's largest finger within the holder 302 without blood blockage, while maintaining contact and retention with the patient's smallest finger that can fit within the holder 302. In some examples, to avoid the hard tissue of the patient's finger 319, the wings 338 may be positioned on the finger receiving portion 320 at a location proximal to the patient's fingernail and distal to the first joint of the patient's finger.

[0122] The holder 302 can be configured to allow a user to repeatedly compress and release the wings 338 to push and / or extract blood from the finger 319 until a desired amount of blood flows through the attachment 228 and into the collection container 12. The wings 338 are configured to maintain light contact with a range of patient finger sizes that may be used with the holder 302 and flex to hold the holder 302 on the patient's finger 319. The wings 338 may also provide an active pressure feature to the holder 302.

[0123] In some examples, the holder 302 can include a stability extension 340, which provides additional support for the holder 302 to be securely placed on the finger 319. In one embodiment, the finger receiving portion 320 forms a generally C-shaped member and includes a plurality of inner gripping members to provide additional grip and support for the holder 302 to be securely placed on the patient's finger 319. The stability extension 340 helps maintain contact with the patient's finger 319 while avoiding the patient's finger's 319 blood supply and knuckles during use of the holder 302.

[0124] The lancing device 310 for obtaining a blood sample also includes a lancet housing or lancet 304 (shown in FIG. 7B) that is removably connectable to the port 326 of the holder 302 prior to inserting the port into the tubular body of the accessory. The lancet housing or lancet 304 can include an entrance or opening 350, an interior 352, a puncturing element 354, an engagement portion 356, a retractable mechanism 358, and a drive spring 360. The puncturing element 354 is movable between a pre-actuated position in which the puncturing element 354 is held within the interior 352 of the lancet 304 or lancet housing, and a puncturing position in which at least a portion of the puncturing element 354 extends through the entry opening 350 of the lancet housing or lancet 304 to lance a portion of the finger 319. In one example, the lancet 304 is a contact-activated lancet and can be constructed according to features disclosed in U.S. Patent Application Publication No. 2009 / 0239994, entitled “Contact-Activated Lancet Device,” the entirety of which is incorporated herein by reference.

[0125] In some examples, the holder 302 and the lancet housing or lancet 304 are separate components removably connectable to the port 326 of the holder 302. In such examples, the lancet housing or lancet 304 includes an engagement portion 356. The lancet housing or lancet 304 can be urged into the port 326 of the holder 302 such that the engagement portion 356 of the lancet housing or lancet 304 is locked into the locking portion 332 of the holder 302. In this manner, the lancet housing 304 is securely connected and locked to the holder 302, and the puncturing element 354 of the lancet housing 304 can be actuated to lance or puncture a sample source, such as a finger 319. In some examples, the port 326 of the holder 302 includes a plurality of ribs for securing and locking the lancet 304 to the port 326. The ribs can also be positioned to help secure the collector 246 of the cover 230 within the port 326 when the lancing device 310 is attached to the attachment 228. To actuate the lancet 304, the lancet 304 is pressed against the finger 319, activating the retractable mechanism 358 and driving the spring 360 of the lancet 304 to lance the finger 319. After lancing, the piercing element 354 is immediately retracted and safely secured within the interior 352 of the lancet housing 304.

[0126] To use the lancing device 310 shown in FIGS. 7A-7E, the desired finger 319 is first cleaned and a holder 302 having a size appropriate for the desired finger 319 is selected and securely placed on the finger 319. Next, a lancet housing or lancet 304 is connected to a port 326 of the holder 312. As described above, the lancet housing or lancet 314 can be pushed into the port 326 of the holder 302 such that the engagement portion 356 of the lancet housing or lancet 3104 is locked into the locking portion 332 of the holder 302. In this manner, the lancet housing 304 is securely connected and locked to the holder 302 such that the puncturing element 354 of the lancet housing 304 can be actuated to lance or puncture the finger 319. With the lancet 304 connected to the port 326 of the holder 302, the lancet 304 is in communication with the finger 319.

[0127] When it is desired to actuate the lancet 304 to lance the skin of the finger 319, the lancet 304 is pressed against the finger 319 and the retractable mechanism 358 of the lancet 304 is actuated to lance the finger 319. After lancing the finger 319 to create a blood flow from the finger 319, the lancet 304 is removed from the holder 302 and the lancing device 310 is engaged to the attachment 228 with the port 326 inserted into the collector 246 of the attachment 228, as previously described. With the collection container 12 properly secured to the lancing device 310 via the attachment 228, the patient or practitioner repeatedly compresses and releases the wings 338 of the holder 302 to push and / or extract blood from the finger 319 until a desired amount of blood is collected in the collection container 12. Advantageously, when holder 302 is attached to finger 319, holder 302 defines the incision and finger compression position without restricting blood flow. Squeezing tabs or wings 338 provide a predefined range of squeezing pressure that is consistently applied across finger 319. In doing so, holder 302 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes potential hemolysis.

[0128] Once a desired amount of blood has been collected in the collection container 12, the attachment 228 and lancing device 310 can be disconnected from the collection container 12. The collection container 12 can then be sealed via the cap 26 to provide a sealed sample that can be stored for a period of time and / or transported to another clinical facility, such as a laboratory, for testing and analysis.

[0129] Blood collection and automated processing method Biological samples obtained using the collection containers 12, accessories 28, 128, 228, and assemblies 10, 110, 210 described herein can be processed by automated processing machines. In particular, as previously described, the collection containers 12 or tubes can include an open top end 14 that is flat without protruding structures or other members, meaning that the containers 12 and tubes are adapted to work with a wide variety of automated processes, machines, and devices known in the art. For example, the collection containers 12 can be manipulated by an automated "pick and place" gripping and / or uncapping process. Automated testing processes can also include sorting the collection containers (e.g., by type, size, and / or contents) using a sorting machine. Other automated processes can include filling selected specimen collection containers with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, uncapping, aliquoting, and / or automated labeling of the containers.

[0130] 8 is a flow chart illustrating a method for collecting a biological sample, such as a blood sample, using the collection container 12 and accessory 28, 128, 228 of the present disclosure and for automated processing of the collected biological sample contained in the internal reservoir 24 of the collection container 12. As shown in FIG. 8, the method includes, at step 410, attaching the accessory 28, 128, 228 to the collection container 12 by inserting the inner portion 32, 132, 232 of the accessory 28, 128, 228 through the open first end 14 of the collection container 12.

[0131] For the accessory 228 configured to connect to the piercing device 310, the method may also include, at step 412, attaching the piercing device 310 to the collector 246 of the accessory 228 by inserting the connector 290 of the collector 246 through a corresponding receptacle 312 of the piercing device 310 after attaching the accessory 228 to the collection container 12. At step 414, the method may also include moving the piercing device 310 from a pre-use position (shown in FIG. 4C ) in which the piercing device 310 is spaced apart from the open first end 14 of the collection container 12 to an in-use position (shown in FIG. 4D ) in which the piercing device 310 covers the open first end 14 of the collection container 12.

[0132] At step 416, the method further includes obtaining a blood sample by directing the blood sample through a collector 46, 146, 246 of the attachment 28, 128, 228, through a channel 40, 140, 240 defined by an inner portion 32, 132, 232 of the attachment 28, 128, 228, and into the internal reservoir 24 of the collection container 12. For example, obtaining a blood sample, such as a capillary blood sample, may include lancing a skin surface of a patient and drawing the blood sample into the internal reservoir 24 of the collection container 12 with the collector 46, 146, 246 of the attachment 28, 128, 228. For an attachment 228 attached to the lancing device 310, obtaining a blood sample may include inserting a patient's finger 319 into the holder 302 and lancing the finger 319 with the lancet 304, as previously described.

[0133] In step 418, the method further includes removing the attachment 28, 128, 228 from the open first end 14 of the collection container 12 once the biological or blood sample has been obtained. For example, removing the attachment 28, 128, 228 may include grasping the attachment 28, 128, 228, such as between a thumb and index finger, and pulling the attachment 28, 128, 228 away from the open top end 14 of the collection container 12 such that the inner portion 32, 132, 232 of the attachment 28, 28, 228 slides out of the internal reservoir 24 through the open top end 14 of the collection container 12. Optionally, in step 420, the method may further include, after removing the accessory 28, 128, 228 from the collection container 12, attaching a cap 26 over the open first end 14 of the collection container 12 to seal the biological or blood sample within the internal reservoir 24 of the collection container 12 prior to processing the biological or blood sample.

[0134] At step 422, the method further includes processing the biological or blood sample obtained in the collection container 12 using an automated processing device. For example, as described above, the automated processing device may include one or more devices that perform one or more of the following automated testing processes: sorting collection containers 12 containing blood samples by type, size, and / or contents with an automated sorter, filling selected sample collection containers 12 with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, uncapping, aliquoting, and / or automated labeling of collection containers 12.

[0135] Although examples of accessories, collection containers, blood collection devices, and related assemblies are shown in the accompanying drawings and described in detail above, other examples 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 limiting. The invention described above is defined by the appended claims, and all changes thereto that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A sample collection accessory device configured to attach to an open end of a collection container, comprising: a cover comprising: (i) an inner portion configured for insertion into the collection container, the inner portion having a sidewall with an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against a sidewall of the container; and (ii) an outer portion extending radially outward from the inner portion, the outer portion configured to extend beyond an end of the sidewall of the collection container; a collector extending distally from the cover configured to direct a biological sample into the channel defined by an inner surface of the inner portion of the cover; A sample collection accessory device comprising:

2. The accessory device of claim 1 , wherein the cover and / or collector comprises a flexible plastic material including one or more of silicone, polypropylene, low density polyethylene, synthetic rubber, or natural rubber.

3. The accessory device of claim 2 , wherein the flexible plastic material includes an additive to increase the wettability of a surface of the accessory device.

4. 2. The accessory device of claim 1, wherein the inner portion of the cover is tapered, an outer diameter of a first end of the inner portion is larger than an outer diameter of a second end of the inner portion, and the second end of the inner portion is configured to be inserted into the collection container.

5. 2. The accessory device of claim 1, wherein the outer portion comprises a first end connected to the first end of the inner portion, a second end, and an annular sidewall extending between the first end and the second end of the outer portion, and an outer surface of the inner portion and an inner surface of the sidewall of the outer portion define an annular slot sized to receive a lip feature extending from the open end of the collection container.

6. The accessory device of claim 1 , wherein the accessory device and the collection container are configured for collection and storage of a capillary blood sample.

7. The accessory device of claim 1 , wherein the collector comprises at least one of a scoop, a funnel, or a capillary action member.

8. The accessory device of claim 1 , wherein the cover and the collector are an integral part formed by a single molding process, such as injection molding.

9. 2. The accessory device of claim 1, wherein the collector comprises: (i) a first portion connected to and extending from an inner portion of the cover to guide the sample toward the inner portion of the cover, (ii) a second portion opposite the first portion, and (iii) a guide surface extending between the first portion and the second portion.

10. The accessory device of claim 9 , wherein the second portion of the scoop comprises a curved upper edge that is curved in at least two dimensions.

11. The accessory device of claim 1 , wherein the collector comprises a capillary action rod and is attached to the cover by a wall extending radially between an outer surface of the capillary action rod and the inner surface of the cover.

12. 12. The accessory device of claim 11, wherein the rod extends through the channel defined by the inner surface of the inner portion of the cover, the rod being hollow including an open first end, an open second end, and an annular sidewall extending between the first end and the second end.

13. 10. The accessory device of claim 1, wherein the collector comprises a tubular body defining a channel configured to direct the sample to the channel in the cover, and a connector on an exterior portion of the collector configured to engage a corresponding connector of the lancing device to removably connect the lancing device to the accessory device.

14. 14. The accessory device of claim 13, wherein when engaged with the connector on the outer portion of the collector, the puncture device is positioned over the channel defined by the tubular body to direct the biological sample through the tubular body and cover within an internal reservoir of the collection container.

15. The accessory device of claim 14 , wherein the biological sample travels from the piercing device through the tubular body of the connector and is covered within the internal reservoir of the collection container by gravity.

16. 14. The accessory device of claim 13, wherein the connector is configured to rotatably engage the puncturing device such that the puncturing device is movable from a pre-use position, the puncturing device is spaced from the open end of the collection container, and is movable to the in-use position, the puncturing device covering the open end of the collection container.

17. 14. The accessory device of claim 13, wherein the connector comprises a cylindrical member configured for insertion into a corresponding receptacle of the lancing device, the cylindrical member being retained within the receptacle of the specimen collection container by a snap-fit ​​connection.

18. 20. The accessory device of claim 17, wherein the collector further comprises a latch configured to engage a portion of the lancing device to maintain the lancing device in an in-use position, the lancing device covering the open end of the collection container.

19. a collection canister including an open first end, a second end, and an annular sidewall extending between the first end and the second end, the annular sidewall of the collection canister defining an interior reservoir configured to receive a biological sample; an accessory device removably attached to the open first end of the collection container, the accessory device comprising: a cover comprising: (i) an inner portion inserted into the collection container, the inner portion having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against an inner surface of the annular sidewall of the collection container; and (ii) an outer portion extending radially outward from the inner portion and over the open first end of the collection container; a collector extending distally from the cover configured to direct the biological sample through the channel defined by the inner surface of the inner portion of the cover and into the internal reservoir; A collection assembly comprising:

20. 1. A method for automated blood sample processing, comprising: attaching an accessory device to a collection container by inserting an inner portion of the accessory device through an open first end of the collection container, the accessory device including a cover including: (i) an inner portion with a sidewall having an inner surface defining a channel through the accessory device and an outer surface having an outer diameter sized to seal against the inner surface of the sidewall of the collection container; and (ii) an outer portion extending radially outward from the inner portion configured to extend over the open first end of the collection container, and a collector extending distally from the cover configured to direct the blood sample into the channel defined by the inner surface of the inner portion of the cover; directing the blood sample through the collector and into an internal reservoir of the collection container and obtaining the blood sample through the channel defined by the interior portion of the accessory device; removing the accessory device from the open first end of the collection container when the blood sample has been obtained; and processing the obtained blood sample in the collection container using at least one automated processing device.

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