Accessory device for sample collection, collection assembly and method for automated blood sample processing

Abstract

The invention provides an accessory device for sample collection, a collection assembly and a method for automated blood sample processing. An accessory device for sample collection, the accessory device configured for attachment to an open end of a collection container, the accessory device comprising a cover and a collector. The cover includes an inner portion configured for insertion into a collection container, the inner portion having a sidewall having an inner surface defining a passage through the accessory device and an outer surface having an outer diameter dimensioned to seal against the inner surface of the sidewall of the container. The cover further includes an outer portion extending radially outward from the inner portion, the outer portion configured to extend over an end of a sidewall of the collection container. The collector extends distally from the cover and is configured for directing a biological sample to a channel defined by an inner surface of the inner portion of the cover.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0003] The present disclosure relates to a collector accessory or accessory device, such as a cap, enclosure, cover, lid, sealing member or similar device, which is configured to be mounted to the open end of a small volume collection container, such as a small volume collection container configured to receive a capillary blood sample, the small volume collection container including a collector for guiding a biological sample obtained from a patient (such as a sample for medical diagnostic testing) through the open end and into the interior of the small volume collection container. Background Art

[0004] Devices for collecting biological samples are commonly used in the medical industry. A common blood collection technique is capillary blood collection for obtaining small volume blood samples, which can be used for testing to treat and monitor various conditions and diseases. For example, capillary blood samples are regularly collected from diabetic patients for blood tests to monitor the patient's blood sugar level 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.

[0005] The blood collection process for obtaining 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 for puncturing a patient's skin to obtain a capillary blood sample. Typically, the amount of blood required for such a test is relatively small, and the small puncture wound or incision created by the lancet device typically provides a sufficient amount of blood for these tests. The small volume collection container for capillary blood collection is typically a tubular container, such as a straight-walled microtube. After the sample is collected in the container, the collection container can be sealed by a cap assembly that is inserted into or above the open end of the collection container. The sealed container can be provided to a laboratory for processing, such as for automated diagnostic testing.

[0006] The automated testing process may include sorting the collection containers (e.g., by type, size, and / or contents) using a sorting machine. Other automated processes may include: filling the selected sample collection container with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, decapping, aliquoting, and / or automated labeling of the container. Conventional collection containers may not be compatible with any or all automated processing machines used to process and analyze the collected blood samples. For example, due to the unique or irregular geometries of some collection container components, lids, enclosures, seals, or other components, automated sorting machines may not be able to sort conventional sample collection containers (e.g., by type, size, and / or contents). Therefore, there is a need in the art for a more universal sample collection container having a regular geometry that is compatible for use with a variety of automated processing machines. The sample collection containers and components disclosed herein are configured to provide such universal compatibility, meaning that these sample collection containers can be used with many different automated machines and devices. Summary of the invention

[0007] In view of the difficulty of processing traditional sample collection containers using automated systems and devices, the present disclosure is directed to sample collection containers having a simple geometry that is compatible with various automated devices and systems. In particular, the sample collection containers disclosed herein are expected to be compatible with various front-end automated devices, automated analyzers, and / or back-end automated devices, thereby providing improved workflow efficiency compared to traditional manual processing. The present invention also relates to accessory devices or accessories for such blood collection containers, which can be used during blood collection and removed prior to automated processing of the collection container containing the biological sample. Therefore, the accessories will not interfere with automated processing devices, such as sorting devices, additive injection devices, centrifuge devices, or mass analysis devices for processing biological samples.

[0008] According to one aspect of the present disclosure, an accessory device for sample collection is configured to be attached to an open end of a collection container, the accessory device comprising a cover and a collector. The cover comprises an inner portion, the inner portion being configured to be inserted into the collection container, the inner portion comprising a sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the sidewall of the collection container. The cover also comprises an outer portion extending radially outward from the inner portion, the outer portion being configured to extend above the end of the sidewall of the collection container. The collector extends distally from the cover and is configured to guide a biological sample to the passage defined by the inner surface of the inner portion of the cover.

[0009] According to another aspect of the present disclosure, a collection assembly includes a collection container having 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 defines an internal reservoir configured to receive a biological sample. The collection assembly also includes an accessory device removably mounted to the open first end of the collection container. The accessory device includes a cover and a collector. The cover includes an inner portion that is inserted into the collection container, the inner portion having a sidewall, the sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, and the outer diameter of the outer surface being sized to seal against the inner surface of the annular sidewall of the collection container. The cover also includes an outer portion that extends radially outward from the inner portion and extends above the open first end of the collection container. The collector extends distally from the cover and is configured to guide the biological sample through the passage defined by the inner surface of the inner portion of the cover and into the internal reservoir of the collection container.

[0010] According to another aspect of the present disclosure, a method for automated blood sample processing includes mounting an accessory device to a collection container by inserting an inner portion of the accessory device into an open first end of the collection container. The accessory device includes a cover and a collector. The cover includes an inner portion, the inner portion including a sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the 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, the outer portion being configured to extend over the open first end of the collection container. The collector extends distally from the cover and is configured to direct a biological sample to the passage defined by the inner surface of the inner portion of the cover. The method also includes obtaining the blood sample by directing the blood sample through the collector and into an internal reservoir of the collection container via the passage defined by the inner portion of the accessory device. The method further includes: once the blood sample is obtained, removing the accessory device from the open first end of the collection container; and processing the obtained blood sample in the collection container using at least one automated processing device.

[0011] Non-limiting examples of the invention will now be described in the following numbered items.

[0012] Article 1: An accessory device for sample collection, the accessory device being configured for attachment to an open end of a collection container, the accessory device comprising: a cover, the cover comprising: (i) an inner portion, the inner portion being configured for insertion into the collection container, the inner portion comprising a side wall, the side wall having an inner surface and an outer surface, the inner surface defining a channel through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the side wall of the collection container; and (ii) an outer portion extending radially outward from the inner portion, the outer portion being configured to extend above the end of the side wall of the collection container; and a collector extending distally from the cover, the collector being configured for guiding 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 the collector comprises a flexible plastic material comprising 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 for increasing the wettability of a surface of the accessory device.

[0015] Article 4: According to any one of Articles 1 to 3, the inner portion of the cover is tapered, wherein the outer diameter of the first end of the inner portion is wider than the outer diameter of the second end of the inner portion, and wherein the second end of the inner portion is configured to be inserted into the collection container.

[0016] Clause 5: The accessory device of any one of Clauses 1 to 4, wherein the channel defined by the inner surface of the inner portion of the cover is tapered, wherein a diameter at a first end of the channel is wider than a diameter at a bottom end of the channel.

[0017] Article 6: The accessory device of any one of Articles 1 to 5, wherein the outer portion includes a first end, a second end, and an annular sidewall, the first end being connected to the first end of the inner portion, and the annular sidewall extending between the first end and the second end of the outer portion.

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

[0019] Clause 8: The accessory device of any one of Clauses 1 to 7, wherein the axial length of the inner portion is longer than the axial length of the outer portion.

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

[0021] Clause 10: The accessory device of any one of Clauses 1 to 9, wherein the collector comprises at least one of a scoop, a funnel, or a capillary action member.

[0022] Clause 11: The accessory device of any one 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 biological sample through the accessory device via capillary action.

[0023] Clause 12: The accessory device of any one 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] Article 13: An accessory device according to any one of Articles 1 to 12, wherein the collector includes a spoon portion, which includes: (i) a first portion, which is connected to the inner portion of the cover and extends from the inner portion of the cover to guide the biological sample toward the inner portion of the cover; (ii) a second portion, which is opposite to the first portion; and (iii) a guide surface, which extends between the first portion and the second portion.

[0025] Clause 14: The accessory device of Clause 13, wherein the second portion of the spoon portion comprises a curved top edge, the top edge being curved in at least two dimensions.

[0026] Clause 15: The accessory device of any one of Clauses 1 to 10, wherein the collector comprises a capillary rod mounted to the cover by a wall extending radially between an outer surface of the capillary rod and the inner surface of the inner portion of the cover.

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

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

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

[0030] Article 19: An accessory device according to any one of Articles 1 to 10, wherein the collector includes a tubular body and a connector located on an external portion of the collector, the tubular body defining a channel configured to guide the biological sample to the channel of the cover, and the connector is configured to engage a corresponding receiver of the puncture device for removably connecting the puncture device to the accessory device.

[0031] Article 20: The accessory device of Article 19, wherein, when the piercing device is engaged to the connector on the outer portion of the collector, the piercing device is positioned above the channel defined by the tubular body for guiding the biological specimen through the tubular body and the cover into the internal reservoir of the collection container.

[0032] Clause 21. The accessory device of Clause 20, wherein the biological specimen moves via gravity from the piercing device through the tubular body and the cover of the collector into the internal reservoir of the collection container.

[0033] Article 22: An accessory device according to any one of Articles 19 to 21, wherein the connector is configured to rotatably engage the puncture device so that the puncture device can be moved from a pre-use position to an in-use position, in which the puncture device is spaced apart from the open end of the collection container, and in which the puncture device covers the open end of the collection container.

[0034] Clause 23: The accessory device of any of Clauses 19 to 22, wherein the connector comprises a cylindrical member configured for insertion into a corresponding receptacle of the piercing device.

[0035] Clause 24: The accessory device of clause 23, wherein the cylindrical member is retained within the receptacle of the piercing device by a snap-fit ​​connection.

[0036] Article 25: The accessory device of Article 24, wherein the collector further comprises a latch configured to engage a portion of the piercing device for retaining the piercing device in an in-use position with the piercing device covering the open end of the collection container.

[0037] Article 26: A collection assembly, the collection assembly comprising: a collection container, the collection container comprising an open first end, a second end and an annular side wall extending between the first end and the second end, the annular side wall of the collection container defining an internal reservoir, the internal reservoir being configured to receive a biological sample; and an accessory device, the accessory device being removably mounted to the open first end of the collection container, the accessory device comprising: a cover, the cover comprising: (i) an inner portion, the inner portion being inserted into the collection container, the inner portion comprising a side wall, the side wall having There is an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the annular side wall of the collection container; and (ii) an outer portion extending radially outward from the inner portion and extending above the open first end of the collection container; and a collector extending distally from the cover, the collector being configured to guide the biological sample through the passage defined by the inner surface of the inner portion of the cover and into the internal reservoir of the collection container.

[0038] Clause 27: The collection assembly of Clause 26, wherein the collector of the accessory device comprises at least one of a scoop, a funnel, or a capillary action member.

[0039] Article 28: A collection assembly according to Article 26 or 27, wherein the collector of the accessory device includes a spoon portion, which includes: (i) a first part, which is connected to the inner part of the cover and extends from the inner part of the cover to guide the biological sample to the inner part of the cover; (ii) a second part; and (iii) a guide surface extending between the first part and the second part.

[0040] Clause 29: The collection assembly of clause 26 or clause 27, wherein the collector of the accessory device comprises a capillary rod mounted to the cover by a wall extending radially between an outer surface of the capillary rod and the inner surface of the inner portion of the cover.

[0041] Clause 30: The collection assembly of any one of Clauses 26 to 29, wherein the collection container is a microtube having the internal reservoir having a volume of about 600 μL to 1000 μL.

[0042] Article 31: According to the collection component described in Article 26, the collection component also includes a puncture device for blood collection, which is rotatably mounted to the accessory device, and the puncture device is configured to rotate around the connector of the accessory device between a pre-use position and an in-use position, in which the puncture device is spaced apart from the open first end of the collection container and in which the puncture device is located above the open first end of the collection container.

[0043] Clause 32: The collection assembly of Clause 31, wherein the biological specimen moves via gravity from the piercing device through the collector and the cover of the accessory device into the internal reservoir of the collection container.

[0044] Clause 33: The collection assembly of clause 31 or clause 32, wherein the connector comprises a cylindrical member that is inserted into a corresponding receptacle of the puncture device.

[0045] Clause 34: The collection assembly of clause 33, wherein the cylindrical member is retained within the receptacle of the piercing device by a snap-fit ​​connection.

[0046] Clause 35: A collection assembly according to Clause 33 or 34, wherein the collector further comprises a latch engaging a portion of the piercing device for retaining the piercing device in an in-use position with the piercing device covering the open first end of the collection container.

[0047] Clause 36: The collection assembly of any one of Clauses 31 to 35, wherein the puncture device comprises a receiver sized to receive the connector of the accessory device for securing the puncture device to the accessory device.

[0048] Clause 37: The acquisition assembly of any of Clauses 31 to 36, wherein the receiver comprises an annular member defining an opening sized to receive the connector of the accessory device.

[0049] Article 38: A collection assembly according to any one of Articles 31 to 37, wherein the puncture device comprises: a holder for receiving a sample source, the holder having an actuating portion and a port; a lancet housing, the lancet housing being fixed in the port, the lancet housing having an entrance and an interior; and a puncture element capable of moving between a pre-actuated position and a puncture position, in which the puncture element is retained in the interior and in which at least a portion of the puncture element extends through the entrance.

[0050] Article 39: A method for automated blood sample processing, the method comprising: mounting 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, wherein the accessory device comprises: a cover, the cover comprising: (i) an inner portion, the inner portion comprising a side wall, the side wall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the side wall of the collection container; and (ii) an outer portion extending radially outward from the inner portion, the outer portion being configured The accessory device includes a cover and a collector extending above the open first end of the collection container; and a collector extending distally from the cover, the collector being configured to guide the biological sample into the channel defined by the inner surface of the inner portion of the cover; obtaining the blood sample by guiding the blood sample through the collector and into the internal reservoir of the collection container via the channel defined by the inner portion of the accessory device; once the blood sample is obtained, removing the accessory device from the open first end of the collection container; and processing the obtained blood sample in the collection container using at least one automated processing device.

[0051] Article 40: The method according to Article 39 further includes: after removing the accessory device from the collection container and before processing the blood sample, attaching a cap over the open first end of the collection container to seal the blood sample within the internal reservoir of the collection container.

[0052] 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.

[0053] Article 42: A method according to any one of Articles 39 to 41, wherein the collector of the accessory device includes a spoon portion, which includes: (i) a first part, which is connected to the inner part of the cover and extends from the inner part of the cover to guide the blood sample toward the inner part of the cover; (ii) a second part; and (iii) a guide surface, which extends between the first part and the second part.

[0054] Article 43: The method according to any one of Articles 39 to 41, wherein the collector of the accessory device includes at least one of a rod, a hollow tube or a plastic film, and the rod, the hollow tube or the plastic film is configured to draw the blood sample through the accessory device via capillary action.

[0055] Article 44: A method according to any one of Articles 39 to 43, wherein processing the blood sample in the collection container includes one or more of the following automated testing processes: sorting the collection containers containing the blood samples by type, size and / or contents using an automatic sorting machine; filling the selected sample collection containers with specific additives; centrifugation; visual-based sample quality analysis; serum level analysis; decapping; aliquoting; and / or automated labeling of the collection containers.

[0056] Article 45: The method according to any one of Articles 39 to 44, wherein obtaining the blood sample includes: obtaining a capillary blood sample by piercing the patient's skin surface and extracting the blood sample into the internal reservoir of the collection container using the collector of the accessory device.

[0057] Article 46: A method according to any one of Articles 39 to 41, wherein the collector of the accessory device includes a tubular body and a connector located on an external portion of the collector, the tubular body defining a channel configured to guide the blood sample to the channel of the cover, and the connector is configured to engage a corresponding receiver of the puncture device for detachably connecting the puncture device to the accessory device.

[0058] Clause 47: The method of Clause 46, further comprising: after the accessory device is mounted to the collection container, attaching the puncture device to the collector by inserting the connector of the collector through a corresponding receiver of the puncture device.

[0059] Article 48: The method according to Article 47, wherein the puncture device includes: a holder for receiving a sample source, the holder having an actuating portion and a port; a lancet housing, the lancet housing being fixed in the port, the lancet housing having an entrance and an interior; and a puncture element capable of moving between a pre-actuated position and a puncture position, in which the puncture element is retained in the interior and in which at least a portion of the puncture element extends through the entrance.

[0060] Clause 49: The method of clause 47 or clause 48, wherein the connector is rotatably engaged to the receiver via a snap-fit ​​connection.

[0061] Article 50: The method according to any one of Articles 47 to 49, further comprising: moving the puncture device from a pre-use position to an in-use position, wherein the puncture device is spaced apart from the open first end of the collection container in the pre-use position, and wherein the puncture device covers the open first end of the collection container in the in-use position.

[0062] Article 51: A method according to any one of Articles 39 to 50, wherein the collection container includes the open first end, the second end and an annular side wall extending between the first end and the second end, the annular side wall of the collection container defines the internal reservoir, and the internal reservoir is configured to receive the blood sample.

[0063] Clause 52: The method of any one of Clauses 39 to 51, wherein the collection container comprises a microtube having the internal reservoir, the volume of the internal reservoir being approximately 600 μL to 1000 μL. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1A is a perspective view of a sample collection assembly according to one aspect of the present disclosure, the sample collection assembly including a sample collection container and an accessory mounted to the container.

[0065] Figure 1B yes Figure 1A A perspective view of a cross section of the top portion of the sample collection assembly.

[0066] Figure 1C yes Figure 1A An exploded view of a cross section of the various parts of the sample collection assembly.

[0067] Figure 2A is a perspective view of another example of a sample collection assembly according to an aspect of the present disclosure, the sample collection assembly including a sample collection container and an accessory mounted to the container.

[0068] Figure 2B yes Figure 2A A perspective view of a cross section of the top portion of the sample collection assembly.

[0069] Figure 2C yes Figure 2A An exploded view of a cross section of the various parts of the sample collection assembly.

[0070] Figure 3A is a perspective view of another example of a sample collection assembly according to an aspect of the present disclosure, the sample collection assembly including a sample collection container and an accessory mounted to the container.

[0071] Figure 3B yes Figure 3A A perspective view of a cross section of various parts of a collection container and accessories.

[0072] Figure 3C yes Figure 3A An exploded view of a cross section of the various parts of the sample collection assembly.

[0073] Figure 4A According to one aspect of the present disclosure, before the puncture device is connected to the accessory of the sample collection assembly Figure 3A A stereoscopic view of a sample collection assembly and a puncture device.

[0074] Figure 4B According to one aspect of the present disclosure Figure 4A An exploded perspective view of the collection component and the puncture device.

[0075] Figure 4C According to one aspect of the present disclosure Figure 4A A perspective view of a collection assembly and a puncture device, wherein the puncture device is mounted to the accessory in an open or pre-use position.

[0076] Figure 4D According to one aspect of the present disclosure Figure 4A A stereoscopic view of a collection assembly and a puncture device, wherein the puncture device is mounted to the accessory in a closed or in-use position.

[0077] Figure 5A is an exploded perspective view of a small-volume sample collection container assembly for collecting biological samples according to one aspect of the present disclosure, and the small-volume sample collection container assembly can be used with accessories.

[0078] Figure 5B It is in the pre-centrifugal state Figure 5A A cross-sectional view of a sample collection assembly.

[0079] Figure 5C It is in a centrifugal state Figure 5A A cross-sectional view of a sample collection assembly.

[0080] Figure 5D yes Figure 5A Another cross-sectional view of a capillary collection assembly showing various dimensions of the assembly.

[0081] Fig. 6A is a perspective view of a cap according to one aspect of the present invention, which can be attached to Figure 5A The open top of the specimen collection container.

[0082] Figure 6B yes Fig. 6A Cross-sectional view of the cap.

[0083] Fig. 7A is a perspective view of a sample collection assembly according to one aspect of the present disclosure, the sample collection assembly including a lancing device for obtaining a blood sample from a patient's finger.

[0084] Figure 7B According to one aspect of the present disclosure, a lancet is provided. Fig. 7A Cross-sectional view of the puncture device.

[0085] Figure 7CAccording to one aspect of the present disclosure Fig. 7A A stereoscopic view of a holder of a puncture device.

[0086] Fig.7D is shown connected to a patient's finger to perform a blood collection procedure Figure 7C Schematic diagram of a top view of a retainer.

[0087] Fig. 7E is shown connected to the patient's finger Figure 7C Another schematic diagram of a front view of the retainer.

[0088] Figure 8 is a flow chart illustrating a method of sample collection and automated processing using a small volume sample collection container and accessories according to an aspect of the present disclosure. DETAILED DESCRIPTION

[0089] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for implementation of the present invention. However, various modifications, equivalents, variations and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0090] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the present invention as oriented in the accompanying drawings. The term "proximal" refers to the central or inner part of a device or object. For example, the "proximal" end of a slender member may refer to the end of the member connected to the central part or body of the device. In contrast, the term "distal" refers to the outer part of a device or object that is spaced apart from the central part or body of the device or the object. For example, the "distal" end of a slender member may refer to the end of the member that is farthest from the body of the device and is not connected to other parts of the device. However, it should be understood that the present invention may take alternative variations and step sequences unless there is a clear statement to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following description are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0091] The present disclosure relates to a biological sample collection assembly 10 and a system for collecting biological samples (such as capillary blood samples and other fluid samples), which includes a sample collection container 12 or collection tube for receiving the biological sample. A biological sample (such as a blood sample) can be collected from a patient by a medical professional or practitioner who is trained in obtaining biological samples. The practitioner can be a clinician or a healthcare worker who performs blood drawing, fluid delivery and / or infusion procedures for a patient. For example, a "healthcare worker" can be a medical technician, a phlebotomist, a nurse, or other practitioner who is trained to perform blood drawing procedures in accordance with the aseptic techniques and protocols of a medical institution. The collection assembly 10 disclosed herein can also include an accessory 28 or accessory device that is configured to be connected to a sample collection container (for the purpose of discussion, otherwise referred to as a collection container, container, collection tube) 12 for introducing or directing a biological sample into the interior of the container 12. The assembly 10, container 12, and attachment 28 disclosed herein may be configured to allow improved blood collection from the puncture site into the interior of the container 12, which may be particularly important for sample collection from difficult-to-access capillary puncture sites (such as for infant heel punctures).

[0092] The disclosed attachment 28 can be used with many different types of sample collection assemblies 10, containers 12, and microtubes known in the art. For example, examples of sample collection assemblies that can be used with the attachment 28 are described in U.S. Patent Application Publication No. 2022 / 0280080, entitled “Small Volume Collection Container,” which is incorporated herein by reference in its entirety. In some examples, as shown, for example, in Figure 1A , a sample collection container 12 includes a body or tube having an open first end or open top end 14, a second end or bottom end 16 that may be closed or open, and an annular sidewall 18 extending between the open first end or open top end and the closed or open second end or bottom end. The open top end 14 may be a suitable size and / or shape for collecting a sample from a puncture site (such as a patient's skin surface). As described in more detail herein, in some examples, the open top end 14 may have a flat 360° lip feature (or lip portion) 20 (e.g., a lip portion) surrounding the open top end 14 of the container 12. FIG. 5A to FIG. 5D). When the bottom end 16 of the container 12 is open, the sample collection container 12 may 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. The annular sidewall 18 and / or any inner wall of the collection container 12 may define an interior or internal reservoir 24 of the container 12, which is sized to contain a volume of a biological sample sufficient to perform a diagnostic test. For example, the collection container 12 may be a microtube having an internal reservoir 24 having a volume of approximately 600 μL to 1000 μL. The collection assembly 10 may also include a cap 26 (e.g., FIG. 5A to FIG. 6B ), the cap is configured to be connected to the collection container 12 to close the open top end 14 of the collection container 12 to ensure that the biological sample is located in the internal reservoir 24 of the container 12.

[0093] The sample collection container 12 is configured to receive and store biological samples for analysis and testing. As used herein, a "biological sample" may refer to a sample comprising one or more biological fluids (e.g., one or more liquids, one or more mixtures, and / or one or more solutions 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 refer to a mammalian organism, and the collection container 12 of the present disclosure may be used for sample collection procedures performed on humans and / or animals. For the purpose of diagnostic testing, the collection container 12 may be used for the collection, storage, and eventual transfer of biological samples. For example, the collection container 12 may be configured for proteomics, molecular diagnostics, chemical sampling, blood or other body fluid collection, coagulation sampling, and hematology sampling, etc.

[0094] In some examples, the collection container 12 and attachment 28 disclosed herein are configured to improve biological specimen collection for an automation-compatible, small volume specimen collection container, wherein the geometry of the container has been challenged by design constraints for compatibility with multiple front-end automation and analyzer systems. These constraints may result in the collection container 12 having a geometry that is not suitable for traditional capillary blood collection, thus determining that the attachment 28 is needed to improve specimen collection. For these reasons, the attachment 28 is intended to improve the ease of biological specimen collection for an automation-compatible, small volume collection container 12, including improving blood flow, eliminating red cell hang up in the open end of the collection container 12, hemolysis, and other sample quality-related factors that may typically be a problem in capillary blood.

[0095] More specifically, the collection container 12 having a flat, open top end 14 or a lip feature 20 can be generally symmetrical about its longitudinal axis X1, which means that the collection container 12 can be inserted into an automated processing machine in many or all orientations. The collection container 12 having a flat, open top end 14 can be used with automated front-end processes (such as automated sorting machines and other types of automated devices) for preparing samples for appropriate analysis. These devices may include, for example, devices for performing the following operations: filling a selected sample collection container with specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, decapping, aliquoting and / or automated labeling of the container. The collection container 12 can also be compatible with automated analysis procedures and accommodate automated diagnostic and / or analytical probes or other sample extraction equipment. The collection container can also be compatible with automated back-end processes (such as resealing, storage and retrieval) employed after the sample is analyzed.

[0096] In some examples, the collection containers of the present disclosure can be used with different commercially available automated sample analyzers. Examples of such analyzers may include, but are not limited to: P512, P612, c501, c502, c602, e601, e602, e801 and / or e802; DxA, AU5800, DCX700AU, Dxl, and / or Falcon from Beckman Coulter; SH, CH and / or IA; from Ortho Clinical Diagnostics and / or GLP, a3600, Alinity, and / or Architect from Abbott.

[0097] The present disclosure also relates to an accessory 28 or accessory device for use with a collection container 12 that facilitates or simplifies obtaining, collecting, storing and / or manipulating a collected sample. More specifically, the accessories 28 of the present disclosure may include various caps, enclosures, covers, lids, and other sealing members configured to be positioned above the open top end 14 of the collection container 12. The accessory 28 may include one or more structures that guide a biological sample from a collection location (such as a puncture site on the patient's skin) to an internal reservoir 24 of the collection container 12. In some examples, the accessory 28 may be a single-use, disposable device that is configured to be attached to the open top end 14 of the collection container 12 prior to collection and to be discarded after collection.

[0098] In some examples, the attachment 28 may include a plastic collection device including a cap portion connected to the open top end 14 of the collection container 12. The attachment 28 may also include a distal extension collector (such as an extension tool) extending from the cap portion, the distal extension collector configured to flow the biological sample from the sample collection site (e.g., a skin puncture site or a vascular access site) into the internal reservoir 24 of the collection container 12. The attachment 28 may also include other mechanical flow-guiding structures (e.g., glass or plastic capillary action structures (e.g., such as a tube, rod, or plastic film) that can be connected to the open top end 14 of the collection container 12, 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 12.

[0099] Accessory including scoop for blood sample collection

[0100] The biological sample collector assembly 10 disclosed herein includes a detachable sample collection accessory 28 adapted to facilitate sample collection, an example of which is FIG. 2A to FIG. 2C As shown in the figure. Other attachments 128 and 228 are as follows FIG. 2A to FIG. 5B As shown. The attachment 28, 128, 228 is configured to be removably mounted or attached to the open top end 14 of the collection container 12 during biological sample collection. For example, the attachment 28, 128, 228 may include a guide surface or member that is configured to guide a biological sample from a patient (e.g., from a puncture site) through the attachment 28, 128, 228 and into the interior of the collection container 12. The biological sample can be moved through the attachment 28, 128, 228 via gravity, capillary forces, or other passive or active transport forces to move a small volume of fluid sample from a first location to a second location. Once the biological sample is acquired and moved to the interior of the collection container, the attachment 28, 128, 228 can be removed and the collection container 12 can be capped (e.g., using a 6A to 7C26) until the biological sample is ready for testing.

[0101] like Figures 1A to 1C As shown, a sample collection attachment 28 of the sample collection assembly 10 (the sample collection attachment includes a geometry that facilitates the collection of a biological sample (e.g., a capillary blood sample)) is configured to be attached to the open top end 14 of the collection container 12. The attachment 28 includes a cap, cap portion, or cover 30 that is configured to be positioned above the open top end 14 of the collection container 12. The cover 30 can have a concentric arrangement of an inner annular member or inner portion 32 and an outer annular member or outer portion 34, the inner annular member or inner portion being configured for insertion into the collection container 12, the outer annular member or outer portion surrounding the inner portion 32. The inner portion 32 can include a sidewall 36 having: an inner surface 38 that defines a fluid or flow 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 through the attachment 28); and an outer surface 42 that has a maximum or widest outer diameter OD1 (such as Figure 1B and Figure 1C ), the outer surface is sized to contact, press against and / or seal against the inner surface 44 of the side wall 18 of the collection container 12. Figures 1A to 1C As shown, the outer portion 34 of the cover 30 extends over and / or around the open top end 14 of the collection container 12, thereby preventing fluid from flowing into or out of the internal reservoir 24 of the collection container 12 other than through the 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, which is configured to guide the biological sample to the channel 40 defined by the inner surface 38 of the inner portion 32.

[0102] The cover 30 is generally shaped to direct the biological specimen into the interior reservoir 24 of the collection container 12. For example, Figures 1A to 1C As shown, 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, the maximum outer diameter OD1 of the first end or top end 48 of the inner portion 32 can be wider than the outer diameter OD2 of the second end or bottom end 50 of the inner portion 32 (e.g., Figure 1B and Figure 1C14 , the second or bottom end is sized to be inserted into the collection container 12. Having a tapered outer surface 42 of the inner portion 32 can make it easier for the attachment 28 to slide through the open top 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, wherein the inner diameter ID1 at the top end 48 of the inner portion 32 is wider than the inner diameter ID2 at the bottom end 50 of the inner portion 32. The taper and / or size of the top end 48 and the bottom end 50 of the inner portion 32 can be selected to ensure that the fluid flows efficiently through the channel 40. In particular, the taper angle can be steep enough to ensure that the biological specimen moves through the channel 40 in a controlled manner. However, desirably, the bottom end 50 of the inner portion 32 is wide enough to ensure that solid components of the collected biological specimen (such as platelets, minerals, and other particles) do not adhere to the inner surface 38 of the inner portion 32 or otherwise impede the flow of fluid through the attachment 28.

[0103] The outer portion 34 of the cover 30 can be an annular or tubular structure having a first end or top end 54, an open second end or bottom end 56 opposite the top end 54, and a sidewall 58 extending around the inner portion 32 between the top end 54 and the bottom end 56 of the outer portion 34. The top end 54 of the outer portion 34 can be connected to the top end 48 of the inner portion 32 or be integral with the top end of the inner portion. In addition, as shown in FIG. Figure 1B and Figure 1C As shown, the outer surface 42 of the inner portion 32 and the inner surface 60 of the outer portion 34 define an annular groove 62 that is sized to receive the open top end 14 of the collection container 12. In some examples, the 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 is sufficient to hold the accessory 28 in place to prevent the accessory 28 from sliding out of the collection container 12 at an unexpected or inconvenient time. As previously described, the size of the accessory 28 is generally dependent on the size of the collection container 12 and / or the automated processing machine with which the collection container is used.

[0104] The attachment 28 also includes a collector 46 extending distally from the cover 30, which is configured to direct the collected biological sample to the channel 40 defined by the inner surface 38 of the inner portion 32 of the cover 30. The collector 46 can be any structure configured to direct the biological sample from, for example, a puncture site on the patient's skin (e.g., a skin puncture site) to the channel 40 of the cover 30. For example, the collector 46 can include an angled, curved, bent, or tapered surface for directing the biological sample toward the channel 40. In other examples, the collector 46 can include a tubular and / or elongated member to direct the fluid sample toward 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 spoon, a wedge, a funnel, and / or a capillary action device (e.g., a rod, a tube, a membrane, or a similar structure) for directing the biological sample toward the channel 40 and / or toward the internal reservoir 24 of the collection container 12.

[0105] The cover 30 and / or collector 46 can be formed of or include a flexible plastic and / or elastic material (such as silicone, polypropylene, low-density polyethylene, synthetic rubber (e.g., polychloroprene), natural rubber (e.g., isoprene)), or can be formed of or include a harder and / or more rigid material (such as a rigid thermoplastic material such as acrylonitrile butadiene styrene (ABS), polyester, polycarbonate, polypropylene, high-density polyethylene or polyethylene terephthalate), or can be formed of or include glass and other ceramic materials. In some examples, the attachment 28 can be a single molded component manufactured by a conventional molding process (such as injection molding). In this case, the inner portion 32 and the outer portion 34 of the cover 30 can be integral with the collector 46. For example, the guide surface of the collector 46 can extend seamlessly 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 interfere with the flow of biological specimens through the attachment 28 to the internal reservoir 24 of the collection container 12. In some examples, the inner surface 38 of the inner portion 32 and / or other surfaces of the attachment 28 can include an additive material for increasing the wettability of the surface of the attachment 28. The additive material can be added to the plastic or precursor material to manufacture the attachment 28 before molding, and / or the additive material can be applied to the surface of the molded part after molding and / or curing.

[0106] Continue to refer Figures 1A to 1CIn some examples, the collector 46 of the attachment 28 is a scoop configured to be pressed against the patient's skin, which provides a flow path from the puncture site of the skin through the attachment 28 and to the internal reservoir 24 of the collection container 12. By using the scoop, the practitioner is able to effectively obtain a blood sample, thereby allowing a sufficient amount of the sample to pass through the attachment 28 to reach the collection container 12. In some examples, the collector 46 or scoop can include a first, proximal or bottom portion 66 that is connected to the interior portion 32 and extends from the interior portion to guide the sample toward the channel 40 extending through the interior 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 portion 68 of the collector 46 or scoop may also include a curved top edge that is radially curved about the longitudinal axis X2 of the attachment 28 and about an axis that is generally transverse to the longitudinal axis X2 of the attachment 28, i.e., the top edge may be curved in at least two dimensions. The guide surface is provided to guide the biological specimen toward 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 is inclined from the top portion 68 or top edge of the collector 46 toward the longitudinal axis of the container 12 and the attachment 28. In other examples, the guide surface 64 may be a flat or planar angled surface that is not inclined or curved toward the central axis or central portion of the guide surface 64.

[0107] As previously described, the attachment 28 is removably inserted into the open top end 14 of the collection container 12. Figure 1C Attachment 28 is shown removed from collection container 12. To install attachment 28 to the open top end of collection container 12, as shown by arrow A1 ( Figure 1C ), 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 such that the outer surface 42 of the inner portion 32 of the cover 30 contacts the inner surface 44 of the side wall 18 of the collection container 12. The practitioner then pushes the inner portion 32 into the interior reservoir 24 of the collection container 12 such that the bottom end 56 of the outer portion 34 contacts the annular ridge 70 or ring extending radially outward from the side wall 18 of the collection container 12. As previously described, the top end 14 of the collection container 12 slides into the groove 62 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 mounted to the collection container 12, a collector 46 (such as a scoop) extends distally from the top end 48 of the inner portion 32 of the cover 30 or the top end 54 of the outer portion 34, as shown in FIG. Figure 1A and Figure 1B shown.

[0108] In contrast to the collector assembly 10 of the present disclosure including a detachable attachment 28, many conventional collection containers or tubes have an open top end with one or more collector structures (such as a scoop) extending distally from a top lip portion of the collection container or tube. These conventional collectors or scoops are typically integral with the top lip portion of the container or tube and extend distally from the top lip portion of the container or tube. However, manufacturing containers including an integral scoop may be complex, requiring more complex tools or additional tools to form the scoop than required for containers or tubes with a flat open top end. Containers with an integral scoop may also not work well with automated processing machines because such containers may need to be positioned in a manner such that the scoop is in a specific orientation in order to be recognized and / or manipulated by the automated machine. For example, the vision system of some automated machines may only be able to recognize a container when the scoop is in a specific orientation. However, before using the automated machine, it is necessary to ensure that each container is properly positioned, which increases the time and manpower required to process the filled collection containers. Therefore, it is believed that the collection assembly 10 disclosed herein including the removable and / or disposable attachment 28 provides substantial advantages in terms of manufacturability and versatile automated processing as compared to conventional collection assemblies and containers.

[0109] Accessories with capillary action for blood sample collection

[0110] FIG. 2A to FIG. 2C Another example of a sample collection assembly 110 is shown that includes an attachment 128 configured to be mounted to the open top end 14 of the collection container 12. As in the previous examples, the attachment 128 includes a cover 130 that includes an inner portion 132 that is configured to be inserted into the interior 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 passage 140 through the attachment 128 and an outer surface 142 that has an outer diameter that is 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 above the open top end 14 of the collection container 12.

[0111] The attachment 128 also includes a collector 146 extending distally from the cover 130 and configured to direct the biological sample to the channel 140 defined by the inner surface 138 of the inner portion 132 of the cover 130. However, unlike the previous examples, in FIG. 2A to FIG. 2BThe collector 146 of the accessory 128 shown in the figure is a capillary action device (such as a rod, a column or a plastic film) which is configured to draw or cause the flow of a biological sample along one or more surfaces of the capillary action device to transport the biological sample (such as a capillary blood sample) from a puncture site on the patient's skin to the internal reservoir 24 of the collection container 12.

[0112] like Figure 2B and Figure 2C As most clearly shown, the capillary rod or device can 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 the bottom 178. The sidewall 180 of the elongated tube can define a narrow flow channel extending from the top 176 to the bottom 178 of the rod, the narrow flow channel being sized for capillary action of a sample therethrough.

[0113] like FIG. 2A to FIG. 2C As shown, the capillary action rod or device is mounted to the cover 130 by a wall 172 (which extends radially between the outer surface 174 of the capillary action rod or device and the inner surface 138 of the inner portion 132 of the cover 130) so that the rod or device extends through the channel 140 defined by the inner surface 138 of the inner portion 132 of the cover 130. The distal end or top 176 of the rod can extend distally in the distal direction to exceed the top end 148 of the cover 130. In a similar manner, the proximal end or bottom 178 of the rod can extend beyond the bottom end 150 of the cover 130. For example, the annular sidewall 180 of the rod or device can have a total length L3. In addition, the sidewall 180 can extend distally beyond the top end 148 of the cover 130 by a distance D1. The rod can also extend proximally in the proximal direction beyond the bottom end 150 of the cover 130 by a distance D2.

[0114] FIG. 2A to FIG. 2C The accessory 128 is mounted to the collection container 12 in a similar manner as in the previous example. Figure 2C As shown, the attachment 128 is initially separated from the collection container 12. When the biological sample is ready to be obtained, it can be removed by moving in the direction of arrow A2 (such as Figure 2C The accessory 128 is 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. The cover 130 is then advanced onto the collection container 12 so that the bottom end 156 of the outer portion 134 is placed against the annular ridge 70 or ring of the collection container 12 and the open top end 14 of the collection container 12 is moved into the annular groove 162 defined by the outer surface 142 of the inner portion 132 of the cover 130 and the inner surface 160 of the outer portion 134.

[0115] Accessories and lancing devices for blood sample collection

[0116] FIG. 3A to FIG. 4D Another example of a sample collection assembly 210 is shown, which includes 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 piercing device 310 (e.g., 4A to 4D The puncture device 310 is also referred to as a blood collection device or blood collection assembly. The puncture device 310 includes a holding structure or holder for supporting a finger or other body part (e.g., a patient's finger or toe) and includes or is coupled to a lancet for puncturing the patient's skin surface. The puncture device 310 may also include various surfaces and flow channels for guiding the biological sample from the puncture site to, for example, the internal reservoir 24 of the collection container 12. FIG. 3A to FIG. 3C Attachment 228 is shown proximate to the collection container. 4A to 4D The collection container 12, the attachment 228 and the puncturing device 310 are shown.

[0117] The attachment 228 may include one or more connectors, latches, locks, or similar mechanical fasteners for engaging the puncturing device 310, thereby securing the puncturing device 310 to the attachment 228. Once the puncturing device 310 is secured to the collection container 12 and punctures the patient's skin, the biological sample may flow through the guide surface or channel of the puncturing device 310, through the attachment 228, and into the internal reservoir 24 of the collection container 12. The puncturing device 310 may be any of a variety of commercially available or specially manufactured devices for puncturing a patient's skin and obtaining a fluid biological sample, including a lancet, needle, sharp, or similar device known in the art that may be adapted to engage with the attachment 228 of the present disclosure. 4A to 4D and 7A to 7EAn exemplary puncture device 310 is shown in the figure, which is called a capillary blood collector device, which can be used with the accessories of the present disclosure. Other puncture devices or blood collection devices that can also be used with the accessory 228 are described in U.S. Patent No. 11,399,755, entitled "Device for Obtaining a Blood Sample", U.S. Patent Application Publication No. 2019 / 0223772, entitled "Device for the Attached Flow of Blood", and PCT Application Publication No. WO 2020 / 167746, entitled "Capillary collector with rotatable connection", and the disclosure of each of these documents is incorporated herein by reference in its entirety.

[0118] As in the previous example, FIG. 3A to FIG. 4D The attachment 228 includes a cover 230 including an inner portion 232 configured to be inserted into the collection container 12 and an outer portion 234 extending above the open top end 14 of the collection container 12. The inner portion 232 includes a sidewall 236 having an inner surface 238 defining a passage 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 collection container 12.

[0119] The attachment 228 also includes a collector 246 extending distally from the cover 230 and configured to direct the acquired biological sample to the channel 240 defined by the inner surface 242 of the inner portion 232 of the cover 230. FIG. 3A to FIG. 3C As shown, collector 246 is an annular or tubular body defining a channel 282 configured to direct the biological sample to channel 240 that extends through cover 230 or a cover portion of attachment 228. The tubular body may include a funnel-shaped or tapered inner surface 284 for directing the biological sample toward channel 240 of cover 230. In some examples, collector 246 may also include an annular shelf 286, shoulder, ridge, or similar support surface located on the inner surface 284 of the collector, which is configured to align with and support a corresponding outflow port or outlet of puncture device 310 so that the biological sample flows directly from puncture device 310 into channel 240 defined by inner portion 232 of cover 230. As shown in FIG. Figure 3B and Figure 3C As most clearly shown, the collector 246 can also include an external shelf 288 or shoulder portion located on the outside of the collector 246 that is configured to receive corresponding structure of the piercing device 310 to support the piercing device 310 when it is installed to the attachment 228.

[0120] The collector 246 of the attachment 228 may also include a connector 290 extending from a portion of the collector 246, the connector being configured to be coupled to a corresponding receiver 312 (eg, 4A to 4D 246) to secure the piercing device 310 to the attachment 228. When the piercing device 310 is engaged with the collector 246, the piercing device 310 is positioned above the channel 240 defined by the inner portion 232 of the cover 230, which means that the sample enters the channel 240 from the outlet or port of the piercing device 310. The biological sample then passes through the channel 240 of the cover 230 into the internal reservoir 24 of the collection tube 12. In particular, the piercing device 310 and the attachment 228 can be configured so that the acquired biological sample flows into the internal reservoir 24 of the collection container 12 via gravity through the channel 282 of the collector 246 and the channel 240 of the cover 230.

[0121] In some examples, the connector 290 can be a post, protrusion, or protruding member, such as a cylindrical member, extending from the outer surface of the collector 246. The protruding member can be configured to be received in a corresponding receiver 312 (e.g., 4A to 4D 228) and / or inserted into a corresponding receiver (such as an annular ring or circular opening of the piercing device 310) to removably secure the piercing device 310 to the accessory 228. The connector 290 may include ribs, lips, protrusions, ridges, or similar raised portions extending around the outer surface of the connector 290 so that the connector 290 forms a snap-fit ​​connection with the receiver 312 of the piercing device 310.

[0122] In some examples, connector 290 is configured to rotatably engage piercing device 310. For example, connector 290 can be shaped to allow receiver 312 of piercing device 310 to rotate around connector 290 in a clockwise and / or counterclockwise connection. Piercing device 310 can be configured to rotate in the direction of arrow A3 (e.g., Figure 4B and Figure 4C from the position before use (as shown) Figure 4C Rotate to the use position (as shown) Figure 4D282 of the collector 246, and in the use position, the outflow port of the puncture device 310 is connected to or covers the opening of the channel 282 of the collector 246. For example, when ready to perform a skin puncture and obtain a biological sample, the practitioner can rotate the puncture device 310 toward the opening to the channel 282. The practitioner can rotate the puncture device 310 in the opposite direction, which moves the outflow port of the puncture device 310 away from the channel 282 to access the internal reservoir 24 of the collection container 12. 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 detach the puncture device 310 from the attachment 228.

[0123] In some examples, the attachment 228 also includes a latch 292 that is configured to engage a portion of the piercing device 310 to hold the piercing device 310 in place. Figure 4D The latch 292 may 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. 4A to 4D As shown, the piercing device 310 includes a corresponding latch receiver 314 (such as a square or rectangular ring or opening) that is configured to receive the latch 292 to lock the piercing device 310 in the use position.

[0124] Same as the previous example, FIG. 3A to FIG. 4D The attachment 228 is mounted to the open top end 14 of the collection container 12. Specifically, as Figure 3C As shown, the attachment 228 can be initially disposed separately from the collection container 12. When the biological sample is ready to be collected, as shown in FIG. Figure 3C As shown by arrow A4 in the figure, the accessory 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. The cover 230 is then pushed onto the collection container 12 so that the bottom end 256 of the outer portion 234 is placed against the annular ridge 70 or ring of the collection container 12, and wherein the open top end 14 of the collection container 12 is received in the annular groove 262 defined by the outer surface 242 of the inner portion 232 of the cover 230 and the inner surface 260 of the outer portion 234. Once the accessory 228 is installed to the collection container 12, the piercing device 310 is installed to the accessory 228 by inserting the connector 290 or protruding member of the accessory 228 through the receiver 312 of the piercing device 310, as shown by arrow A5 (as shown in FIG. Figure 4B290 (as shown in FIG. 290 ), thereby detachably engaging the piercing device 310 to the accessory 228. Once the piercing device 310 is attached to the accessory 228, the piercing device 310 can be removably engaged by rotating the receiver 312 around the connector 290 (as shown in FIG. 290 ). Figure 4B and 4C )) so that the puncture device 310 is moved from the pre-use position ( Figure 4C Move to the use position (as shown) Figure 4D ), thereby moving the piercing device 310 over 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.

[0125] Capillary sample collection container

[0126] As previously mentioned, the attachment devices or attachments 28, 128, 228 disclosed herein are configured to be connected to collection containers of various shapes and configurations, including but not limited to, for example Figures 1A to 4D The collection container 12 shown. The attachments 28, 128, 228 can also be connected to different types of collection containers (including collection containers with different shapes, lengths, and material compositions). Having described the features of the exemplary attachments 28, 128, 228 in detail, reference will now be made to FIG. 5A to FIG. 5D Additional features of a sample collection assembly 10 including a collection container 12 and a cap 26 are described. Specifically, the figures show a sample collection assembly 10 including a collection container 12 (also referred to as a collection tube) for collecting a biological sample, and a cap 26 that is configured to be mounted to the open top end 14 of the container 12 to seal the acquired biological sample within the internal reservoir 24 of the collection container 12. For example, after acquiring the biological sample, 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 14 of the container 12 to store and / or preserve the biological sample contained in the container. However, it should be understood that FIG. 5A to FIG. 5D The components of the collection assembly 10 and collection container 12 shown in FIG. 1 are exemplary only, and many other types and configurations of collection containers may be used with the accessory devices or accessories 28 , 128 , 228 of the present disclosure.

[0127] As mentioned above, FIG. 5A to FIG. 5DAs shown, the collection container 12 includes a body or tube having an open top end 14, a second end or bottom end 16, and an annular sidewall 18 extending between the top end and the second end or bottom end. The open top end 14 can be a suitable size and / or shape for collecting a sample from a puncture site, such as a patient's skin surface. In some examples, the open top end 14 can have a flat 360° lip feature 20 surrounding the open top end 14 of the container 12. When the bottom end 16 of the container 12 is open, the sample collection container 12 can also include a plug 22 configured to couple to the bottom end 16 of the collection container 12 to close the bottom end 16 of the collection container 12. The annular sidewall 18 and / or any inner wall of the collection container 12 can define an interior or internal reservoir 24 of the container 12, which is sized to contain a volume of a biological sample sufficient to perform a diagnostic test. For example, the volume of the internal reservoir 24 can be about 600 μL to about 1000 μL.

[0128] In some examples, the collection container 12 is a microtube suitable for capillary collection of a blood sample, the overall outer dimensions of the microtube conforming to a standard tube (e.g., 13 mm×90 mm) for compatibility with standard testing instruments 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 corresponding to the volume of the biological sample contained within the collection container 12.

[0129] 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. The vision / camera system can be configured to read the unique tube outer profile, thereby appropriately identifying and sorting the tube for further analytical processing.

[0130] In some examples, the internal reservoir 24 of the collection container 12 can have an overall height to diameter ratio to produce a taller blood or sample column within the collection container 12, even when the volume of blood or sample collected is relatively low (e.g., 800 μL or less), compared to conventional containers including an internal reservoir having a constant diameter and straight walls.

[0131] In some examples, the collection container 12 includes an open lip portion 20 that is uniform along the entire circumference of the collection container, meaning that the lip portion 20 does not include a scoop, ridge, protrusion, or other extension that is present in many conventional collection containers. Specifically, the open lip portion 20 can be substantially planar around the entire 360° circumference of the open top end 14 of the collection container 12. In addition, the open lip portion 20 can be flat so that a plane passing through the lip portion is transverse to the longitudinal axis X1 of the collection container 12. The uniform open lip portion 20 avoids the disadvantages of conventional collection tubes, in which an extension or collector portion extending distally from the top of the container may be incompatible with automated processing machines. In particular, as described above, a collection container 12 having a uniform lip portion 20 has the same appearance regardless of orientation. In this way, regardless of how the collection container 12 is stored or oriented, the collection container 12 has an external geometry that can be more easily identified by a visual / camera system.

[0132] like FIG. 5A to FIG. 5D as well as Fig. 6A and Figure 6B As shown, the assembly 10 may 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. After the sample contained in the collection container is collected and the attachment 28, 128, 228 is removed from the open top end 14 of the container, the cap 26 may be removably attached to the collection container 12. In some examples, the cap 26 may be made of a mixture of a rigid or semi-rigid material and a flexible material (such as a thermoplastic elastomer). In addition, in some examples, the material and / or geometry of the cap 26 may be selected to allow one-handed enclosure and initial sealing of the collection container 12, which means that the cap 26 may be easily closed with little required force. The cap 26 should also provide a high sealing pressure during centrifugation to prevent leakage. In some examples, the centrifugation process may be a reverse centrifugation process in which the collection container 12 is inserted into the centrifuge in an inverted orientation (i.e., wherein the lid of the collection container 12 is positioned in the bottom of the receiving chamber or well of the centrifuge). Therefore, the cap 26 may be designed to withstand the forces applied to 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, transport, and handling of the collection container 12 .

[0133] In some examples, the capillary collection container assembly 10 further includes 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 end 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 automation racks and carriers. The bottom plug 22 can be configured for a press-fit interference connection with the collection tube 12 within the open bottom end 16 of the collection container 12.

[0134] Figure 5B and Figure 5C is in the pre-centrifugal state ( Figure 5B ) and post-centrifugation state ( Figure 5C ) is a cross-sectional view of the collection container assembly 10. Figure 5B and Figure 5C As shown, the cap 26 is configured to be coupled to the collection container 12 around the open top end 14 of the container 12 so as to effectively close and seal the internal reservoir 24. More specifically, in some examples, the upper portion of the collection container 12 can define the internal reservoir 24 for the collection, holding and ultimate transfer of the biological specimen. The internal reservoir 24 can extend from the open top end 14 of the container 12 to the circular bottom 72 of the collection container 12. The circular bottom 72 can be an inner wall extending inwardly from the inner surface 44 of the side wall 18 of the container 12, which defines the bottom portion of the internal reservoir 24. In some examples, the internal reservoir 24 can be coated with one or more additives (e.g., a coagulation activator, lithium heparin, an anticoagulant additive, etc.). The additive can be sprayed or otherwise injected into the collection container 12 for maintaining the blood or sample specimen contained in the collection container 12 during storage, or for other diagnostic purposes known to those of ordinary skill in the art.

[0135] like Figure 5B and Figure 5C As shown, the internal reservoir 24 is defined within the sidewall 18 of the container 12, wherein the sidewall 18 has a generally angled and rounded profile that terminates 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 compared to a container having an inner surface 44 that extends completely from the top end 14 to the bottom end 16 and is defined by the sidewall 18 of the container 12, so as to produce a taller blood or sample column within the collection container 12, thereby providing better visualization and / or simplifying the collection of the sample collected within the internal reservoir 24 and reducing "dead volume", and being compatible with sample volume detection systems. For example, the angle of the inner surface 44 relative to the longitudinal axis X1 of the collection container 12 can be between 2.5° and 10°, thereby providing a taller sample column compared to a tube having an internal reservoir with non-angled (or minimally angled) sidewalls.

[0136] 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 end 16 of the container 12, and the rounded bottom 72 of the collection container 12. The "false" bottom cavity 74 of the lower portion of the collection container 12 can aid in injection molding of the collection container 12 by promoting plastic flow. Furthermore, by extending the lower portion of the collection container 12 in this manner and also by providing the bottom plug 22 in the bottom end 16 of the container 12, the collection assembly 10 can be more easily compatible with standard medical testing instruments and / or automated processes.

[0137] As mentioned above, Figure 5B The collection container 12 is depicted in a pre-centrifugation state. In this state, the internal reservoir 24 may contain a gel separation substance 76 at its bottom portion, and a sample specimen 78 (e.g., a blood sample) having a total density lower than that of the gel separation substance 76 is held above the gel separation substance 76. Upon centrifugation of such a collection container 12, the main components of the blood (e.g., plasma / serum and hematocrit, which is mainly composed of red blood cells) are separated by density, wherein the hematocrit having a higher density is precipitated at the bottom of the internal reservoir 24, while the plasma / serum having a lower density is collected above the hematocrit. At the same time, the gel separation substance 76 is configured to have a density between the density of the plasma / serum and the density of the hematocrit. Therefore, upon centrifugation, the gel separation substance 76 forms a barrier between the plasma / serum and the hematocrit.

[0138] Figure 5C The collection container 12 is shown in a centrifuged state. Figure 5C In the embodiment of the present invention, the sample specimen 78 has been separated into two major component portions, specifically into a plasma / serum portion 80 and a hematocrit portion 82. In addition, after centrifugation, the gel separation material 76 migrates from the bottom portion of the internal reservoir 24 to create an effective barrier between the plasma / serum portion 80 and the hematocrit portion 82. Because the overall size of the internal reservoir 24 is reduced relative to the size of the entire collection container 12, the plasma / serum portion 80 of the sample specimen 78 is easily visible to the user and can be used for analyzer / probe aspiration even in the case of relatively low volumes of collected capillary blood.

[0139] Figure 5D Table 1 shows the dimensions of the collection container 12 and cap 26 of the collection container assembly 10. However, it should be understood that the dimensions of the collection container 12 and cap 26 described herein are not limited to the dimensions of the collection container 12 and cap 26 of the collection container assembly 10. Figure 5D The dimensions shown in and Table 1 are illustrative only, and the collection container assembly 10 is not limited to these dimensions or size ranges.

[0140] Table 1:

[0141] Size Identifier Assembly Features Nominal size (mm) A Tube length (with cap) 75-95 B Tube length (without cap) 70-90 C Internal reservoir length of tube 35-55 D Tube opening 5-12 E Tube opening 5-12 (not shown) Bottom of tube 3-9 G Bottom of tube 7-15 (not shown) Tube 10-15 J Cap Height 15-25

[0142] As referenced Figure 5D As can be seen from the dimensions shown and described in Table 1, the overall length of the internal reservoir 24 (C) is much less than the overall length of the collection container 12 (B), thereby enabling the collection container 12 to handle small volume samples while still maintaining a traditional form factor for use with standard medical testing instruments and / or automated processes. In addition, because the inner diameter of the collection container bottom is significantly smaller than the inner diameter of the collection container opening (D), thereby forming a tapered sidewall 18, a taller blood or sample column is provided, thereby allowing for improved sample visibility, sample collection, and / or barrier separation between sample components.

[0143] Fig. 6A and Figure 6B is an enlarged view of the cap 26, which can be connected to the open top end 14 of the collection container 12 after the attachment 28 is removed from the collection container 12. The cap 26 is configured in a generally cylindrical shape having a bottom annular portion 84 and a top annular surface 88, the bottom annular portion defining an opening 86. A plurality of vertically extending ribs 90 extend between the top annular surface 88 and the bottom annular portion 84. In contrast to conventional caps having a generally cylindrical shape and / or ribs that extend less than 360° around the cap, the ribs 90 can extend 360° around the cap 26 to facilitate gripping and decapping during automated processing. Within the interior of the top annular surface 88, the cap 26 may include a cavity portion 92 defined by side walls (e.g., Figure 6B ). The cavity 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 disposed on the collection container 12.

[0144] In addition, the cap 26 may further include a downwardly extending side wall portion 94 (eg, Figure 6B84 and the collection container 12, which form a gap between the bottom annular portion 84 and the sidewall portion 94. Although not shown, the cap 26 can be secured in place on the collection container 12 via a snap groove located on the cap 26 and / or the collection container 12, wherein the snap groove provides audible feedback and / or tactile feedback to the user to confirm that the cap 26 is secured to the collection container 12. In addition, the base portion of the cap 26 can 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 can be coupled by any suitable method, such as, for example, a threaded interface, a bayonet interface, etc.

[0145] Sample collection kit and puncture device

[0146] As mentioned earlier, FIG. 3A to FIG. 4D The attachment 228 in the embodiment can be configured to engage with various different types of puncture devices or sample collection devices, such as devices including lancets, sharps, needles, and sharp elongated members for skin puncture. 7A to 7E Additional features of an exemplary puncture device 310 that can be used with the accessory 228 are described in detail. However, it should be understood that other types of puncture devices and sample collection devices can also be used with the accessories of the present disclosure. For example, certain puncture devices and sample collection devices can be modified to include various connectors, receivers, latches, and other mechanisms for mounting the device to the previously described accessories 228 and similar devices.

[0147] like 7A to 7E As shown, the lancing device 310 can be, for example, a stand-alone and fully integrated finger-based capillary blood collection device that is capable of pricking, collecting, and stabilizing a high volume (e.g., up to 500 microliters or more) of capillary blood samples in the sample collection container 12. The lancing device 310 can also be formed of separable components (e.g., a finger sleeve and a lancet) that can be connected together and / or used together to obtain a blood sample.

[0148] Reference Fig. 7A and Figure 7B The puncture device 310 includes an integral retainer 302 and a lancet housing or lancet 304 (eg, Figure 7B ), for puncturing a patient's finger 319 (as shown in Fig. 7A , Fig.7D and Fig. 7E319 ). In other examples, the lancet housing 304 can be separated from the holder 302. The holder 302 is configured to receive a sample source (e.g., a patient's finger 319) 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 fingertip protector 330. In some examples, the fingertip protector 330 provides a stop portion for properly aligning and securing the finger 319 within the holder 302. The fingertip protector 330 also helps ensure that the patient's finger 319 is placed in a proper position within the finger receiving portion 320 so that the pressure applied to the patient's finger 319 will produce sufficient blood flow. The fingertip protector 330 can have a curved fingertip support that ensures that the patient's finger 319 stops at the end of the finger receiving portion 320 while allowing the patient's nail to leave the end of the finger receiving portion 320. The finger receiving portion 320 allows the retainer 302 to be used with artificial nail styles and natural nail styles present in the patient population.

[0149] The first opening 322 of the finger receiving portion 320 is configured to receive a sample source, such as a finger 319. The sample source may also include other body parts 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, in the case where the finger 319 is 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 (e.g., Figure 7B ) and a collector 246 for receiving the accessory 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 also includes a locking portion 332 for securely receiving the lancet housing or lancet 304 and the collector 246 of the accessory 228 within the port 326.

[0150] The actuating portion 324 of the puncture device 310 can be switched between a first position and a second position, in which the holder 302 defines a first diameter, and in which the holder 302 defines a second diameter, wherein the second diameter is less than the first diameter. In addition, in the first position, the holder 302 defines a first elliptical shape. In the second position, the holder 302 defines a second elliptical shape, wherein the first elliptical shape is different from the second elliptical shape. In this way, when the holder 302 is in the second position of reduced diameter, a portion of the holder 302 contacts a sample source (e.g., a finger 319), and the actuating portion 324 of the holder 302 can pump and / or extract blood.

[0151] In some examples, the actuation portion 324 includes a contact member 334. When the actuation portion 324 is in the first position, the contact member 334 is in a disengaged position, i.e., the contact member 334 is disposed in a first position relative to the sample source such that the contact member 334 can be in light contact with the sample source. When the actuation portion 324 is in the second position, the contact member 334 is in an engaged position, i.e., the contact member 334 is disposed in a second position relative to the finger 319 such that the contact member 334 is in pressure-applying contact with the finger 319 and the actuation portion 324 of the holder 302 is able to pump 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.

[0152] In some examples, the actuation portion 324 includes a pumping member 336, such as a pair of opposing tabs or wings 338, for applying pressure to the finger 319. 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 a practitioner or patient to squeeze the wing 338 between a first position (passive state) and a second position (active state). It is believed that the use of the tabs or wings 338 to draw blood from the patient's finger 319 minimizes hemolysis while maintaining adequate blood flow from the patient's finger 319. The resting position and hinge of the wings 338 are designed to maintain contact and retention with the smallest patient's finger that can fit into the holder 302, while flexing to accommodate the largest patient's finger within the holder 302 without blocking the blood. In some examples, wing 338 may be positioned on finger receiving portion 320 at a location proximal to the patient's nail and distal to the patient's first knuckle to avoid hard tissue on the patient's finger 319 .

[0153] The holder 302 can be configured to allow a user to repeatedly squeeze and release the wings 338 to pump 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 flex to maintain gentle contact with a range of patient finger sizes that can be used with the holder 302 and to hold the holder 302 on the patient's finger 319. The wings 338 can also provide an active pressure feature to the holder 302.

[0154] In some examples, the holder 302 can include a stability extension 340. This provides additional support for the holder 302 to securely place the holder on the finger 319. In one example, the finger receiving portion 320 forms a generally C-shaped member and includes a plurality of internal gripping members for providing additional grip and support for the holder 302 to securely place the holder on the patient's finger 319. The stability extension 340 helps maintain contact with the patient's finger 319 during use of the holder 302 while avoiding the blood supply and knuckles of the patient's finger 319.

[0155] The puncture device 310 for obtaining a blood sample also includes a lancet housing or lancet 304 (eg, Figure 7B ), the lancet housing or lancet is removably connected to the port 326 of the holder 302 before it is inserted into the tubular body of the accessory. The lancet housing or lancet 304 may include an inlet or opening 350, an interior 352, a puncture element 354, an engagement portion 356, a retractable mechanism 358, and a drive spring 360. The puncture element 354 may be capable of moving between a pre-actuated position and a puncture position, in which the puncture element 354 is retained within the interior 352 of the lancet 304 or lancet housing, and at least a portion of the puncture element 354 extends through the inlet 350 of the lancet housing or lancet 304 to puncture a portion of the finger 319. In one example, the lancet 304 is a contact activated lancet and may be constructed according to features disclosed in U.S. Patent No. 9,380,975, entitled "Contact Activated Lancet Device," which is incorporated herein by reference in its entirety.

[0156] In some examples, the holder 302 and the lancet housing or lancet 304 are separate components that can be removably connected 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 pushed into the port 326 of the holder 302 so that the engagement portion 356 of the lancet housing or lancet 304 is locked within the locking portion 332 of the holder 302. In this way, the lancet housing 304 is securely connected and locked to the holder 302 so that the puncture element 354 of the lancet housing 304 can be activated to puncture 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 in the port 326. These ribs may also be positioned to help secure the collector 246 of the cover 230 within the port 326 when the lancing device 310 is mounted to the attachment 228. To activate the lancet 304, the lancet 304 is pushed against the finger 319 to activate the retractable mechanism 358 and drive the spring 360 of the lancet 304 to pierce the finger 319. After piercing, the piercing element 354 is immediately retracted and securely secured within the interior 352 of the lancet housing 304.

[0157] To use 7A to 7E The puncture device 310 shown, first cleans the desired finger 319, and selects a holder 302 of appropriate size for the desired finger 319, and securely places the holder on the finger 319. Next, the lancet housing or lancet 304 is connected to the port 326 of the holder 302. As previously described, the lancet housing or lancet 304 is pushed into the port 326 of the holder 302 so that the engagement portion 356 of the lancet housing or lancet 304 is locked in the locking portion 332 of the holder 302. In this way, the lancet housing or lancet 304 is securely connected and locked to the holder 302 so that the puncture element 354 of the lancet housing 304 can be activated to puncture 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.

[0158] When it is desired to activate the lancet 304 to puncture the skin of the finger 319, the lancet 304 is pushed against the finger 319 to activate the retractable mechanism 358 of the lancet 304 to puncture the finger 319. After puncturing the finger 319 to generate blood flow from the finger 319, as previously described, the lancet 304 is removed from the holder 302 and the puncture device 310 is engaged to the accessory 228, wherein the port 326 is inserted into the collector 246 of the accessory 228. With the collection container 12 properly secured to the puncture device 310 by the accessory 228, the patient or practitioner repeatedly squeezes and releases the wings 338 of the holder 302 to pump and / or extract blood from the finger 319 until the desired amount of blood is collected in the collection container 12. Advantageously, with the holder 302 placed on the finger 319, the holder 302 does not restrict blood flow and defines the puncture position and the finger squeeze position. The squeezing tabs or wings 338 provide a predetermined squeezing pressure range that is applied consistently across the finger 319. By doing so, the holder 302 provides a gentle, controlled massage of the finger 319 that stimulates blood extraction and minimizes any potential hemolysis.

[0159] Once the desired amount of blood has been collected within the collection container 12, the attachment 228 and lancing device 310 may be detached from the collection container 12. The collection container 12 may then be sealed via the cap 26 to provide a sealed sample that may be stored for a period of time and / or transported to another clinical facility (such as a laboratory) for testing and analysis.

[0160] Blood collection and automated processing methods

[0161] 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 container 12 or tube can include an open top end 14 that is flat and has no protruding structures or other components, which means that the container 12 and tube are suitable for working with various automated processes, machines and devices known in the art. For example, the collection container 12 can be manipulated by an automated "pick and place" gripping and / or decapping process. The automated testing process 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 the selected sample collection container with a specific additive, centrifugation, vision-based sample quality analysis, serum level analysis, decapping, aliquoting, and / or automated labeling of the container.

[0162] Figure 81 is a flow chart illustrating a method for collecting a biological sample (such as a blood sample) using the collection container 12 and accessories 28, 128, 228 of the present disclosure and for automating the processing of the collected biological sample contained in the internal reservoir 24 of the collection container 12. Figure 8 As shown, the method includes, at step 410 , mounting 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 .

[0163] For an accessory 228 configured to be connected to a puncture device 310, the method may further include, at step 412, after mounting the accessory 228 to the collection container 12, attaching the puncture device 310 to the collector 246 of the accessory 228 by inserting the connector 290 of the collector 246 through the corresponding receiver 312 of the puncture device 310. At step 414, the method may further include moving the puncture device 310 from a pre-use position (e.g., Figure 4C as shown) to the in-use position (as shown) Figure 4D As shown), in the pre-use position, the piercing device 310 is spaced apart from the open first end 14 of the collection container 12, and in the in-use position, the piercing device 310 covers the open first end 14 of the collection container 12.

[0164] At step 416, the method further includes obtaining a blood sample by directing the blood sample through the collector 46, 146, 246 of the accessory 28, 128, 228 and into the internal reservoir 24 of the collection container 12 via the channel 40, 140, 240 defined by the internal portion 32, 132, 232 of the attachment 28, 128, 228. For example, obtaining a blood sample (such as a capillary blood sample) may include piercing the skin surface of a patient and extracting the blood sample into the internal reservoir 24 of the collection container 12 using the collector 46, 146, 246 of the attachment 28, 128, 228. For the attachment 228 attached to the lancing device 310, as previously described, obtaining a blood sample may include inserting the patient's finger 319 into the holder 302 and lancing the finger 319 using the lancet 304.

[0165] At step 418, the method further includes, once the biological or blood sample is obtained, removing the attachment 28, 128, 228 from the open first end 14 of the collection container 12. For example, removing the attachment 28, 128, 228 may include, such as grasping the attachment 28, 128, 228 between a thumb and an index finger, and pulling the attachment 28, 128, 228 away from the open top end 14 of the collection container 12, which causes the inner portion 32, 132, 232 of the attachment 28, 128, 228 to slide out of the internal reservoir 24 through the open top end 14 of the collection container 12. Optionally, at step 420, the method may further include 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 after removing the attachment 28, 128, 228 from the collection container 12 and before processing the biological or blood sample.

[0166] At step 422, the method also includes using an automated processing device to process the acquired biological sample or blood sample in the collection container 12. For example, as previously described, the automated processing device may include one or more devices that perform one or more of the following automated testing processes: sorting the collection container 12 containing the blood sample by type, size, and / or content using an automated sorting machine; filling the selected sample collection container 12 with a specific additive; centrifugation; visual-based sample quality analysis; serum level analysis; decapping; aliquoting; and / or automated labeling of the collection container 12.

[0167] Although different examples of accessories, collection containers, blood collection devices, and associated components are shown in the 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. Therefore, the foregoing description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention that fall within the equivalent meaning and equivalent range of the claims will be included within the scope of the claims.

Claims

1. An accessory device for sample collection, the accessory device being configured to be attached to an open end of a collection container, the accessory device comprising: a cover comprising: an inner portion configured for insertion into the collection container, the inner portion comprising a sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the sidewall of the collection container; and an outer portion extending radially outwardly from the inner portion, the outer portion being configured to extend over an end of the sidewall of the collection container; and A collector extends distally from the cover, the collector being configured to direct a biological sample into the channel defined by the inner surface of the inner portion of the cover.

2. The accessory device according to claim 1, wherein: The cover and / or the 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 according to claim 2, wherein: The flexible plastic material comprises an additive for increasing the wettability of a surface of the accessory device.

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

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

6. The accessory device according to claim 1, wherein: The accessory device and the collection container are configured for collecting and storing capillary blood samples.

7. The accessory device according to claim 1, wherein: The collector includes at least one of a scoop, a funnel, or a capillary action member.

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

9. The accessory device of claim 1, wherein: The collector includes a scoop portion, which includes: a first portion, the first portion is connected to the inner portion of the cover and extends from the inner portion of the cover to guide the biological sample toward the inner portion of the cover; a second portion, the second portion is opposite to the first portion; and a guide surface, the 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 includes a curved top edge that is curved in at least two dimensions.

11. The accessory device of claim 1, wherein: The collector includes a capillary rod mounted to the cover by a wall extending radially between an outer surface of the capillary rod and the inner surface of the inner portion of the cover.

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

13. The accessory device of claim 1, wherein: The collector includes a tubular body defining a channel configured to direct the biological sample to the channel of the cover, and a connector located on an outer portion of the collector, the tubular body being configured to engage a corresponding receiver of a puncture device for removably connecting the puncture device to the accessory device.

14. The accessory device of claim 13, wherein: When the piercing device is engaged to the connector on the outer portion of the collector, the piercing device is positioned over the passage defined by the tubular body for directing the biological specimen through the tubular body and the cover into the internal reservoir of the collection container.

15. The accessory device of claim 14, wherein: The biological specimen moves via gravity from the puncturing device through the tubular body and cover of the collector into the internal reservoir of the collection container.

16. The accessory device of claim 13, wherein: The connector is configured to rotatably engage the puncturing device so that the puncturing device can be moved from a pre-use position, in which the puncturing device is spaced apart from the open end of the collection container, to an in-use position, in which the puncturing device covers the open end of the collection container.

17. The accessory device of claim 13, wherein: The connector comprises a cylindrical member configured for insertion into a corresponding receptacle of the puncture device, and Therein, the cylindrical member is retained in the receiver of the puncture device by a snap-fit ​​connection.

18. The accessory device of claim 17, wherein: The collector also includes a latch configured to engage a portion of the piercing device for retaining the piercing device in an in-use position with the piercing device covering the open end of the collection container.

19. A collection component, comprising: a collection container comprising 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 interior reservoir configured to receive a biological specimen; as well as an accessory device, the accessory device being removably mounted to the open first end of the collection container, the accessory device comprising: a cover comprising: an inner portion that is inserted into the collection container, the inner portion including a sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against an inner surface of the annular sidewall of the collection container; and an outer portion that extends radially outward from the inner portion and extends over the open first end of the collection container; and A collector extends distally from the cover, the collector being configured to direct the biological specimen through the passage defined by the inner surface of the inner portion of the cover and into the interior reservoir of the collection container.

20. A method for automated blood sample processing, the method comprising: The accessory device is mounted to the collection container by inserting an interior portion of the accessory device through the open first end of the collection container, wherein the accessory device comprises: a cover comprising: an inner portion including a sidewall having an inner surface and an outer surface, the inner surface defining a passage through the accessory device, the outer surface having an outer diameter sized to seal against the inner surface of the sidewall of the collection container; and an outer portion extending radially outwardly from the inner portion, the outer portion being configured to extend over the open first end of the collection container; and a collector extending distally from the cover, the collector configured to direct a biological sample into the channel defined by the inner surface of the inner portion of the cover; obtaining the blood sample by directing the blood sample through the collector and into the interior reservoir of the collection container via the passageway defined by the interior portion of the accessory device; Once the blood sample is obtained, removing the accessory device from the open first end of the collection container; and The obtained blood sample in the collection container is processed using at least one automated processing device.

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