Sample container for capillary blood

Abstract

A sample collection container configured to be removably mounted to a blood collection device includes a container body and a lid. The container body defines an interior configured to receive a sample provided from the blood collection device. The container body includes an upper portion having an open top and a lower portion having a closed bottom. The lid includes a lid body, a flexible connection coupled between the lid body and the upper portion of the container body, the flexible connection moving the lid between a closed position and an open position, a pierceable septum mounted to the lid body, the pierceable septum sealing the open top of the upper portion when the lid is in the closed position, and a latch. The latch extends from the lid body and engages a catch on the upper portion of the container body to secure the lid in the closed position.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 216,277, filed on June 29, 2021, entitled “Sample Container for Capillary Blood Collection,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to collection containers for containing biological samples (e.g., blood samples). More specifically, this disclosure relates to a sample collection container configured to connect to and receive a blood sample from a finger-based capillary blood collection device, the sample collection container including features for ensuring that the container remains properly closed and sealed to avoid leakage and / or contamination of the blood sample. Background Technology

[0004] Devices used to obtain and collect biological samples (e.g., blood samples) are commonly used in the medical field. One blood collection method commonly used in medicine is capillary blood collection, which is typically used to collect blood samples for testing. Certain diseases (e.g., diabetes) require regular blood tests to monitor, for example, a patient's blood sugar levels. Furthermore, diagnostic kits (e.g., cholesterol test kits) often require blood samples for analysis. The blood collection process usually involves pricking a finger or other suitable body part to obtain a blood sample. Typically, this test requires a relatively small amount of blood, and small puncture wounds or incisions usually provide sufficient blood for these tests. Various types of needle devices have been developed to puncture a patient's skin to obtain capillary blood samples from the patient.

[0005] Many different types of lancet devices are commercially available in hospitals, clinics, and doctors' offices, as well as for individual consumers. These devices typically include a pointed component (e.g., a needle) or a sharp component (e.g., a blade) for quickly piercing a wound or incision in a patient's skin to provide a small amount of blood flow. To simplify capillary blood collection, lancet devices have been developed into automated devices that pierce or cut the patient's skin once actuated by a triggering mechanism. In some devices, the needle or blade remains in a standby position until triggered by the user. Once triggered, the needle or blade pierces or cuts the patient's skin, such as the skin on a finger. Typically, a spring is incorporated into the device to provide the "automatic" force required to pierce or cut the patient's skin.

[0006] U.S. Patent No. 9,380,975 discloses a contact-activated needle device characterized by the automatic ejection and retraction of a piercing or cutting element from the device. This patent is held by the assignee of this application, Becton, Dickinson and Company. The needle device includes a housing and a needle structure having a piercing element. The needle structure is disposed within the housing and adapted to move between a hold or pre-activation position and a puncture position, in which the piercing element is held within the housing, and in the puncture position, the piercing element extends through a front end of the housing. The needle device includes a drive spring disposed within the housing for biasing the needle structure to the puncture position, and a retaining hub for retaining the needle structure in a retracted position against the bias of the drive spring. The retaining hub includes a pivot rod that interferes with the needle structure. An actuator within the housing pivots the rod, thereby moving the needle structure toward a rear end of the housing to at least partially compress the drive spring and release the rod from interference with the needle structure. The received blood sample is then collected and / or tested. This test can be performed by a point-of-care (POC) testing device, or it can be collected and sent to a testing facility.

[0007] The use of needle devices for capillary blood collection can be complex and requires a high level of skill from the healthcare personnel performing the procedure. The multi-step nature of the capillary blood collection process can introduce several variables that may lead to sample quality problems, such as hemolysis, insufficient sample stability, and microclotting. The use of needle devices to obtain blood samples can lead to several variables affecting capillary blood sample collection, including but not limited to keeping the needle stationary during testing, obtaining sufficient blood flow from the puncture site, adequate blood collection, and preventing clotting. Some of the most common sources of procedural variability are: (1) inadequate puncture site cleaning and first drop removal, which may potentially lead to sample contamination; (2) inconsistent puncture location and depth, which may potentially lead to insufficient sample volume and a large amount of interstitial fluid; (3) inconsistent squeezing techniques and excessive pressure near the puncture site to promote blood extraction (e.g., blood squeezing), which may potentially lead to hemolyzed samples; (4) variable transfer interfaces and collection techniques, which may potentially lead to hemolyzed or contaminated samples; and (5) inadequate mixing of the sample with the anticoagulant, which may potentially lead to microclotting.

[0008] Given this common source of process variability and associated sample quality issues, there is a need for blood collection devices and related containers to safely receive and store biological samples in sealed containers with minimal risk of leakage or contamination. Specifically, the collection container of this disclosure is configured to receive fluid samples from a blood collection device and retain the received fluid samples in a securely sealed container until ready for use. Furthermore, the container of this disclosure is configured for ease of use, meaning that the container is easy to close or otherwise operate without requiring significant force from the user during use. Summary of the Invention

[0009] According to one aspect of the invention, a sample collection container configured for removable mounting to a blood collection device includes a container body and a lid. The container body defines an interior configured to receive a sample provided from the blood collection device. The container body includes an upper portion and a lower portion, the upper portion having an open top and the lower portion having a closed bottom. The lid includes: a lid body; a flexible connector located between the lid body and the upper portion of the container body, the flexible connector moving the lid between a closed position and an open position, in which the lid covers the open top of the upper portion and in which the open top of the upper portion is uncovered; a punctureable diaphragm mounted to the lid body, the punctureable diaphragm sealing the open top of the upper portion when the lid is in the closed position; and a latch extending from the lid body and engaging with a latch on the upper portion of the container body to secure the lid in the closed position.

[0010] According to another aspect of the invention, a blood collection container includes a container body having a closed bottom, an open top, and an annular sidewall extending between the closed bottom and the open top. The container also includes a cap detachable from the container body. The cap includes a cap opening bottom removably inserted into the open top, a cap opening top, and an annular sidewall extending between the cap opening bottom and the cap opening top. The container also includes a lid removably mounted on the cap opening top. The cap is sized to press against the container body, and when fully seated on the container body, the cap is restricted from rotation relative to the container body.

[0011] According to another aspect of this disclosure, a blood collection assembly includes: a finger holder including a finger receiving portion and an actuating portion; a container engaging portion connected to the holder; and a collection container removably connected to the container engaging portion. The container includes a container body and a lid, the container body defining an interior configured to receive a sample provided from a blood collection device. The container body includes an upper portion and a lower portion, the upper portion including an open top and the lower portion including a closed bottom. The lid includes: a lid body; a flexible connector located between the lid body and an upper portion of a container body, the flexible connector moving the lid between a closed position and an open position, in which the lid covers the top of an opening in the upper portion and in which the top of an opening in the upper portion is uncovered; a punctureable diaphragm mounted on the lid body, the punctureable diaphragm sealing the top of an opening in the upper portion when the lid is in the closed position; and a latch extending from the lid body, the latch engaging with a latch on the upper portion of the container body to secure the lid in the closed position.

[0012] According to another aspect of this disclosure, a cap removal assembly for removing a cap from a blood collection container body includes: a support and a tool, the support being configured to support the blood collection container in an upright position and restrict rotation of the container relative to the support. The tool includes a cap remover and a handle extending from the cap remover. The cap remover includes a body and at least one protrusion defining an opening or recess sized to receive the cap of the blood collection container, the at least one protrusion extending from the body to the opening or recess, the opening or recess being positioned to engage a portion of the cap such that rotation of the tool relative to the cap releases the cap from the container body.

[0013] Non-limiting illustrative examples of embodiments of this disclosure will now be described in the following numbered clauses.

[0014] Clause 1: A sample collection container configured for removable attachment to a blood collection device, the collection container comprising: a container body defining an interior configured to receive a sample provided from the blood collection device, the container body including an upper portion and a lower portion, the upper portion including an open top and the lower portion including a closed bottom; a lid including: a lid body; a flexible connector located between the lid body and the upper portion of the container body, the flexible connector moving the lid between a closed position and an open position, in which the lid covers the open top of the upper portion and in which the open top of the upper portion is uncovered; a punctureable diaphragm attached to the lid body, the punctureable diaphragm sealing the open top of the upper portion when the lid is in the closed position; and a latch extending from the lid body, the latch engaging with a latch on the upper portion of the container body to secure the lid in the closed position.

[0015] Clause 2: The collection container according to Clause 1, wherein the latch includes a frame and a cushioning pad, the frame being formed of a first material and the cushioning pad being formed of a second material having a lower rigidity than the first material, wherein the cushioning pad is positioned near the leading edge of the frame of the lid and is configured to prevent the latch from disengaging from the latch.

[0016] Clause 3: The collection container according to Clause 2, wherein the frame includes an opening that receives a latch of the upper portion when the lid is in the closed position, and wherein a cushioning pad is positioned between the opening of the frame and the leading edge of the frame.

[0017] Clause 4: The collection container according to Clause 2 or 3, wherein the lid body, the flexible connector and the container body comprise a first material, and wherein the diaphragm comprises a second material.

[0018] Clause 5: The collection container according to any one of Clauses 2 to 4, wherein the first material is a semi-rigid plastic, such as polypropylene, and the second material is a thermoplastic elastomer, such as liquid silicone rubber (LSR), polyurethane rubber, and latex rubber.

[0019] Clause 6: A collection container according to any one of Clauses 1 to 5, wherein the latch of the upper portion of the container body includes a ramp surface positioned such that, when the lid is switched between an open and a closed position, the latch deflects onto the latch before engaging the latch.

[0020] Clause 7: A collection container according to any one of Clauses 1 to 6, wherein the diaphragm includes an inward-facing surface facing the interior of the container body and an outward-facing surface opposite the inward-facing surface, the outward-facing surface including grooves or wells positioned to collect any fluid escaping from the interior of the container body during the retraction of the needle through the diaphragm.

[0021] Clause 8: A collection container according to any one of Clauses 1 to 7, wherein the lid body includes an annular flange defining an opening, and wherein a diaphragm is inserted into the opening, the annular flange being received within an annular recess of the diaphragm.

[0022] Clause 9: A collection container according to any one of Clauses 1 to 8, wherein the diaphragm includes an inward-facing surface that faces the interior of the container body when the lid is in the closed position, and the inward-facing surface of the diaphragm includes a chamfered peripheral edge.

[0023] Clause 10: The collection container according to Clause 9, wherein the inward-facing surface of the diaphragm defines a central cavity that enhances the radial deformation of the diaphragm during centrifugation.

[0024] Clause 11: The collection container according to Clause 10, wherein the central cavity includes a conical annular surface.

[0025] Clause 12: A collection container according to any one of Clauses 1 to 11, wherein the top of the opening of the upper portion includes an annular chamfered edge positioned to contact the chamfered outer edge of the diaphragm when the lid is moved to the closed position.

[0026] Clause 13: The collection container as described in Clause 12, wherein when the lid is in the closed position, the annular chamfered edge of the upper portion deforms the diaphragm, thereby sealing the interior of the container body.

[0027] Clause 14: The collection container as described in Clause 13, wherein the diaphragm is configured to expand radially during centrifugation, thereby enhancing the internal sealing of the container body.

[0028] Clause 15: A collection container according to any one of Clauses 1 to 14, wherein the lower portion of the container body is detachably and removably attached to the upper portion of the container body.

[0029] Clause 16: The collection container according to Clause 15, wherein the upper portion is sized to press against the lower portion, and the upper portion is restricted to rotate relative to the lower portion when the upper portion is fully positioned in the lower portion.

[0030] Clause 17: A collection container according to any one of Clauses 1 to 16, wherein the lower portion of the container body includes a closed bottom of the lower portion, an open top of the lower portion, and an annular sidewall of the lower portion extending between the closed bottom and the open top of the lower portion, and wherein the upper portion of the container body includes an upper opening bottom inserted into the open top of the lower portion of the container body, an open top of the upper portion, and an annular sidewall of the upper portion extending between the upper opening bottom and the open top.

[0031] Clause 18: The collection container according to Clause 17, wherein the lower portion of the container body includes an annular flange extending radially outward from the outer surface of the annular sidewall of the lower portion, and wherein, when the upper portion is inserted into the lower portion, the bottom of the opening of the upper portion contacts the annular flange of the lower portion to restrict rotation of the upper portion relative to the lower portion.

[0032] Clause 19: The collection container according to Clause 18, wherein the annular flange extending from the lower portion and the bottom of the opening of the upper portion include corresponding bevels, which are configured to be axially aligned when the upper portion is inserted into the lower portion.

[0033] Clause 20: The collection container according to Clause 19, wherein rotation of the upper portion relative to the lower portion causes the inclined surface of the upper portion to slide along the inclined surface of the annular flange of the lower portion, thereby lifting the upper portion away from the lower portion.

[0034] Clause 21: A collection container according to any one of Clauses 17 to 20, wherein the lower portion includes an annular protrusion extending radially outward from an outer surface of a sidewall of the lower portion, and wherein an inner surface of a sidewall of the upper portion includes an annular groove receiving the annular protrusion of the lower portion.

[0035] Clause 22: The collection container according to Clause 21, wherein the annular protrusion extending from the lower portion includes an inclined upper surface, a substantially flat lower surface, and a cylindrical peripheral edge extending between the inclined upper surface and the substantially flat lower surface.

[0036] Clause 23: A collection container according to any one of Clauses 17 to 22, wherein the inner surface of the lower portion sidewall includes a tapered portion that tapers radially inward from the top of the lower portion opening.

[0037] Clause 24: The collection container according to Clause 23, wherein there is a tapered interference fit between the outer surface of the lower portion of the sidewall and the inner surface of the upper portion of the sidewall.

[0038] Clause 25: A collection container as described in any of Clauses 1 to 24, wherein the flexible connector includes a hinge.

[0039] Clause 26: A blood collection container comprising: a container body including a closed bottom, an open top, and an annular sidewall extending between the closed bottom and the open top; a cap, detachable from the container body, including a cap opening bottom, a cap opening top, and an annular sidewall extending between the cap opening bottom and the cap opening top; and a lid removably mounted on the cap opening top, wherein the lid is sized to press against the container body and is restricted from rotation relative to the container body when fully seated on the container body.

[0040] Clause 27: A blood collection assembly comprising: a finger retainer including a finger receiving portion and an actuating portion; a container engagement portion connected to the retainer; and a collection container removably connected to the container engagement portion, the container including a container body and a cap, the container body defining an interior configured to receive a sample provided from a blood collection device, the container body including an upper portion and a lower portion, the upper portion including an open top, the lower portion including a closed bottom, and the cap including: a cap body; a position A flexible connector between the lid body and the upper portion of the container body, the flexible connector moving the lid between a closed position and an open position, in which the lid covers the top of the opening of the upper portion, and in which the top of the opening of the upper portion is uncovered; a punctureable diaphragm attached to the lid body, the punctureable diaphragm sealing the top of the opening of the upper portion when the lid is in the closed position; and a latch extending from the lid body, the latch engaging with a latch on the upper portion of the container body to secure the lid in the closed position.

[0041] Clause 28: A cap removal assembly for removing a cap from a blood collection container body, the cap removal assembly comprising: a support configured to support the blood collection container in an upright position and restrict rotation of the container relative to the support; and a tool including a cap remover and a handle extending from the cap remover, the cap remover including a body and at least one protrusion defining an opening or recess sized to receive the cap of the blood collection container, the at least one protrusion extending from the body to the opening or recess, the opening or recess being positioned to engage a portion of the cap such that rotation of the tool relative to the cap releases the cap from the container body.

[0042] Clause 29: The cap removal assembly as described in Clause 28, wherein once the cap is released from the body, the cap can be removed from the body by lifting the cap axially from the body.

[0043] Clause 30: A cap removal assembly as described in Clause 28 or 29, wherein the body includes a ring defining an opening, and wherein the cap can be inserted into the opening when the tool is in an upward or downward orientation.

[0044] Clause 31: The cap removal assembly as described in Clause 30, wherein the tool is operable with the right hand when oriented upwards and with the left hand when oriented downwards.

[0045] Clause 32: A cap removal assembly according to any one of Clauses 28 to 31, wherein the tool further includes a pressing member mounted to the handle and the pressing member includes a distal end extending over an opening in the removable portion, the pressing member being positioned to press the top of the cap when the cap is inserted into the opening, thereby preventing the container from rising from the support when the tool and the cap are rotated relative to the container body.

[0046] Clause 33: A cap removal assembly as described in any of Clauses 28 to 32, wherein the cap removal assembly includes two protrusions that extend into an opening or recess.

[0047] Clause 34: The cap removal assembly as described in Clause 33, wherein the two protrusions are positioned such that a virtual line passing through the center of the opening or recess between the two protrusions is inclined relative to the longitudinal axis of the handle.

[0048] Clause 35: The cap removal assembly as described in Clause 34, wherein the tilt is from about 5 degrees to about 25 degrees, preferably about 15 degrees. Attached Figure Description

[0049] Figure 1A This is a perspective view of a capillary blood collection device and collection container for obtaining a blood sample from a patient's finger, according to one aspect of this disclosure.

[0050] Figure 1B This is a cross-sectional view of a capillary blood collection device and a needle according to one aspect of this disclosure.

[0051] Figure 1C This is a perspective view of a capillary blood collection device holder according to one aspect of this disclosure.

[0052] Figure 1D It shows a device attached to the patient's finger for performing a blood collection procedure. Figure 1C A schematic diagram of the top view of the retainer.

[0053] Figure 1E It shows the connection to the patient's finger. Figure 1C Another schematic diagram of the front view of the retainer.

[0054] Figure 2A This is a perspective view of the top of a sample collection container according to one aspect of this disclosure, wherein the lid is in the open position.

[0055] Figure 2B yes Figure 2A A three-dimensional view of the top of the sample collection container, with the lid in the closed position.

[0056] Figure 2C It is based on one aspect of this disclosure. Figure 2A A cross-sectional view of the top of the sample collection container, with the lid in the closed position.

[0057] Figure 3A and Figure 3B The results of finite element analysis modeling according to an aspect of the invention are shown, demonstrating the sealing force of the diaphragm of the blood collection device after assembly and under high fluid pressure.

[0058] Figure 4A It is a perspective view of a sample collection container according to one aspect of this disclosure, wherein an upper portion or cap is attached to a lower portion.

[0059] Figure 4B for Figure 4A A three-dimensional view of a sample collection container, wherein the upper part or cap is separated from the lower part of the sample collection container.

[0060] Figure 4C yes Figure 4A A cross-sectional view of a sample collection container, wherein the upper portion or cap is attached to the lower portion of the container.

[0061] Figure 4D According to one aspect of the invention Figure 4C An enlarged cross-sectional view of a portion of the sample collection container, showing the interface between the upper part of the container body or the cap and the lower part.

[0062] Figure 5A This is a perspective view of the cap removal component and sample collection container according to aspects of this disclosure.

[0063] Figure 5B yes Figure 5A The cross-sectional view of the cap removal component.

[0064] Figure 5C It is based on one aspect of this disclosure. Figure 5A A 3D view of the tool for removing the cap component.

[0065] Figure 5D It is based on one aspect of this disclosure. Figure 5C The top view of the tool shows the location of the protrusion of the cap remover.

[0066] Figure 5E This is a schematic diagram illustrating the use of tools to release the upper part or cap of a sample collection container from the lower part of the container. Detailed Implementation

[0067] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0068] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may employ alternative variations and sequences of steps unless explicitly stated to the contrary. It should also be understood that the specific apparatus and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0069] This disclosure relates to blood collection devices 10 or assemblies configured to collect capillary blood samples and including a sample collection container 16 for receiving the blood sample. The sample collection container 16 can be used to centrifuge the sample. In particular, this disclosure relates to closures for the container 16, which may include, for example, caps and integrated lids. The caps and integrated lids are configured to provide sufficiently robust closures to maintain a proper seal of the container 16 during and after centrifugation. The container 16 may be made of a rigid or semi-rigid material such as polypropylene. The integrated lid may be made of a mixture of rigid or semi-rigid materials and flexible materials (e.g., thermoplastic elastomers). The material and geometry of the lid are selected to allow for one-handed closure and initial sealing of the container 16, meaning the lid can be easily closed with minimal force. The closure should also provide high sealing pressure during centrifugation to prevent leakage. In some examples, the centrifugation process may be a reverse centrifugation process, wherein the container 16 is inserted into the centrifuge in an inverted orientation (i.e., the lid of the container 16 is positioned at the bottom of the receiving chamber or well of the centrifuge). Therefore, the lid can be designed to withstand the forces applied to it during reverse centrifugation. In some examples, a latch is provided to hold the lid in the closed position and ensure the proper insertion depth of the lid's flexible diaphragm or sealing element.

[0070] This disclosure also relates to a two-piece sample collection container 16 formed by a lower portion or container body and an upper portion or cap. These two portions may be separable and joined together at an interface. The interface between the portions of the container body may be configured to allow for easy assembly of the container body while also providing a secure, hermetically sealed seal between the portions. Equally important, it allows for the controlled removal of the upper portion or cap from the lower portion of the container body, making the fluid contents of the collection container 16 available for analysis. For example, as described in more detail herein, the upper and / or lower portion of the container body may include a ramp or cam surface configured such that rotation of the upper portion relative to the lower portion causes the upper portion or cap to separate from the lower portion of the container body.

[0071] Blood collection components or devices

[0072] Figures 1A to 1EExamples of blood collection devices 10 or components incorporating the features of this disclosure are shown. The blood collection device 10 may be, for example, a stand-alone and fully integrated finger-based capillary blood collection device capable of pricking, collecting, and stabilizing high-volume capillary blood samples, such as up to or exceeding 500 microliters, in a sample collection container 16. The blood collection device 10 or component may also be formed from separable parts (i.e., finger cot, needle, and reservoir) that can be connected together and / or used together to obtain a blood sample. Other exemplary capillary blood collection devices and components that can be modified to include features of this disclosure are described in, for example, U.S. Patent Application Publication No. 2019 / 0216380, entitled “Device for Obtaining a Blood Sample”; U.S. Patent Application Publication No. 2019 / 0223772, entitled “Device for Blood Adhesion Flow”; and PCT Publication No. WO2020 / 167746, entitled “Capillary collector with rotatable connection”, each of which is incorporated herein by reference in its entirety.

[0073] Reference Figure 1A and Figure 1B Example blood collection device 10 includes an integrated retainer 12 and a finger piercing device 19 (e.g., for piercing a patient's finger). Figure 1D and Figure 1E The needle housing or needle 14 (as shown) Figure 1B As shown), and sample collection container 16 (as shown). Figure 1A and 2A to Figure 4D (As shown). In other examples, the blood collection device 10 may be configured as a semi-integrated device 10, which includes, for example, an integrated needle housing 14 and a collection container 16 that can be connected to a separate retainer 12. In other examples, the semi-integrated device 10 may have in-tubular flow and an integrated needle housing 14 and a collection container 16 that can be connected to a separate retainer 12.

[0074] The retainer 12 is configured to receive a sample source (e.g., a patient's finger 19) for use in providing biological samples (e.g., blood samples). Figures 1C to 1EAs shown, the retainer 12 generally includes a finger receiving portion 20 with a first opening 22, an actuating portion 24, a port 26 with a second opening 28, and a fingertip guard 30. In some examples, the fingertip guard 30 provides a stop portion for properly aligning and securing the finger 19 within the retainer 12. The fingertip guard 30 also helps ensure that the patient's finger 19 is properly positioned within the finger receiving portion 20 such that pressure applied to the patient's finger 19 results in sufficient blood flow. The fingertip guard 30 may have a curved fingertip support that ensures the patient's finger 19 stops at the end of the finger receiving portion 20 while allowing the patient's fingernail to exit from the end of the finger receiving portion 20. The finger receiving portion 20 allows the retainer 12 to be used with both artificial and natural nail types present in the patient population.

[0075] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source, such as a finger 19. The sample source may also include other parts of the body capable of fitting into the first opening 22, such as toes or other limbs. Port 26 communicates with the finger receiving portion 20. For example, when the finger 19 is received within the retainer 12, port 26 communicates with a portion of the finger 19. The second opening 28 of port 26 is configured to receive a needle housing or needle 14 (e.g., Figure 1B (as shown) and collection container 16 (as shown) Figure 1A and Figures 2A to 4D (As shown). In some examples, port 26 also includes a locking portion 32 for securely receiving the needle housing or needle 14 and the collection container 16 within port 26.

[0076] The actuating portion 24 of the device 10 can switch between a first position and a second position. In the first position, the retainer 12 defines a first diameter, and in the second position, the retainer 12 defines a second diameter, wherein the second diameter is smaller than the first diameter. Furthermore, in the first position, the retainer 12 defines a first elliptical shape. In the second position, the retainer 12 defines a second elliptical shape, which differs from the first elliptical shape. In this way, when the retainer 12 is in the second position with a reduced diameter, a portion of the retainer 12 contacts the sample source (i.e., finger 19), and the actuating portion 24 of the retainer 12 is capable of pumping and / or aspirating blood, as described in more detail below.

[0077] In some examples, the actuating portion 24 includes a contact member 34. When the actuating portion 24 is in a first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is positioned relative to the sample source such that the contact member 34 can make slight contact with the sample source. When the actuating portion 24 is in a second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is positioned relative to the finger 19 such that the contact member 34 contacts the finger 19 under applied pressure, and the actuating portion 24 of the holder 12 is capable of pumping and / or aspirating blood. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0078] In some examples, the actuating portion 24 includes a pumping member 36 for applying pressure to the finger 19, which is, for example, a pair of opposing tabs or flaps 38. Each flap 38 may include a contact member 34. The retainer 12 may also include a movable hinge portion 42. The movable hinge portion 42 allows the user to squeeze the flaps 38 between a first position (passive state) and a second position (active state). It is believed that using the tabs or flaps 38 to draw blood from the patient's finger 19 minimizes hemolysis while maintaining adequate blood flow from the patient's finger 19. The resting position of the flaps 38 and the hinge are designed to maintain contact and retention with the smallest finger of the patient that can be fitted into the retainer 12, while bending to accommodate the largest finger of the patient in the retainer 12 without obstructing blood flow. In some examples, the flaps 38 may be positioned on the finger receiving portion 20 proximal to the patient's nail and distal to the patient's first interphalangeal joint to avoid hard tissue on the patient's finger 19.

[0079] The retainer 12 can be configured to allow a user to repeatedly squeeze and release the flaps 38 to pump and / or draw blood from the finger 19 until the desired amount of blood fills the collection container 16. The flaps 38 are configured to bend to maintain gentle contact with a range of patient finger sizes that can be used with the retainer 12 and to hold the retainer 12 on the patient's finger 19. The flaps 38 can also provide an active pressure feature to the retainer 12.

[0080] In some examples, the retainer 12 may include a stabilizing extension 40. This provides additional support for the retainer 12 to be securely placed on the finger 19. In one example, the finger receiving portion 20 is formed into a generally C-shaped member and includes multiple internal gripping members that provide additional grip and support for the retainer 12 to securely place the retainer 12 on the patient's finger 19. The stabilizing extension 40 helps maintain contact with the patient's finger 19 during use of the retainer 12 while avoiding blood supply and knuckle damage to the patient's finger 19.

[0081] The blood collection device 10 for obtaining blood samples also includes a needle housing or a needle 14 (such as...). Figure 1B (As shown), the needle housing or needle is detachably connected to port 26 of retainer 12. See reference... Figure 1B The needle housing or needle 14 may include an inlet or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a telescopic mechanism 58, and a drive spring 60. The puncture element 54 is movable between a pre-actuated position and a puncture position. In the pre-actuated position, the puncture element 54 is held within the interior 52 of the needle housing 14. In the puncture position, at least a portion of the puncture element 54 extends through the inlet 50 of the needle housing or needle 14 to puncture a portion of the finger 19. In one example, the needle 14 of this disclosure is a contact-activated needle and can be constructed according to the features disclosed in U.S. Patent No. 9,380,975, entitled “Contact Actiated Lancet Device,” which is incorporated herein by reference in its entirety.

[0082] In some examples, the retainer 12 and the needle housing or needle 14 are separate components that can be detachably connected to port 26 of the retainer 12. In such examples, the needle housing or needle 14 includes an engagement portion 56. The needle housing or needle 14 can be pushed into port 26 of the retainer 12 such that the engagement portion 56 of the needle housing or needle 14 is locked within a locking portion 32 of the retainer 12. In this way, the needle housing 14 is securely connected and locked to the retainer 12, such that the puncture element 54 of the needle housing 14 can be activated to puncture or needle a sample source, such as a finger 19. In some examples, port 26 of the retainer 12 includes multiple ribs for securing and locking the needle 14 or collection container 16 within port 26.

[0083] To activate the puncture needle 14, it is brought against the finger 19 to activate the retractable mechanism 58 and the drive spring 60 of the needle 14 to puncture the finger 19. After puncture, the puncture element 54 immediately retracts and securely holds within the interior 52 of the needle housing 14. Once the finger 19 is punctured, a blood sample is squeezed from the finger 19 into the collection container 16. The collection container 16 may also contain a sample stabilizer (e.g., an anticoagulant) to stabilize the blood sample and / or the composition of the blood sample placed therein. The collection container 16 may also include at least one fill line corresponding to a predetermined volume of sample. The collection container 16 may also indicate / measure the volume of blood collected.

[0084] In order to use Figures 1A to 1EThe capillary blood collection device 10 shown first cleans the desired finger 19 and selects a retainer 12 of appropriate size for the desired finger 19, and securely places the retainer on the finger 19. Next, the needle housing or needle 14 is connected to the port 26 of the retainer 12. As previously described, the needle housing or needle 14 is pushed into the port 26 of the retainer 12 such that the engaging portion 56 of the needle housing or needle 14 is locked within the locking portion 32 of the retainer 12. In this way, the needle housing or needle 14 is securely connected and locked to the retainer 12, such that the puncture element 54 of the needle housing 14 can be activated to puncture or needle the finger 19. With the needle 14 connected to the port 26 of the retainer 12, the needle 14 is in communication with the finger 19.

[0085] When it is necessary to activate the needle 14 to puncture the skin of the finger 19, the needle 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the needle 14 to puncture the finger 19. After the finger 19 is punctured to produce blood flow, the needle 14 is removed from the retainer 12, and then the collection container 16 is pushed into the port 26 of the retainer 12. With the container 16 properly secured to the retainer 12 for blood sample collection, the user repeatedly squeezes and releases the flaps 38 of the retainer 12 to pump and / or aspirate blood from the finger 19 until the desired amount of blood is collected in the collection container 16. Advantageously, because the retainer 12 is placed on the finger 19, the retainer 12 does not restrict blood flow and defines the puncture and finger squeeze location. The squeeze tabs or flaps 38 provide a predefined range of squeeze pressure that is consistently applied across the entire finger 19. By doing so, the retainer 12 provides a gentle massage to the controlled finger 19, which stimulates blood extraction and minimizes any potential hemolysis.

[0086] Once the desired amount of blood has been collected in container 16, the blood collector portion, including collection container 16, can be detached from collection device 10 to allow the collected sample to be sent to diagnostic instruments and / or testing devices. Once detached from collection device 10, the blood collector portion can be sealed via a cap or diaphragm to protectively seal the blood sample within collection container 16.

[0087] Sample collection container lid and latch

[0088] Features of the cap and lid of container 16 are as follows Figures 2A to 2C As shown. As previously described, the interface between the cap and the lid is configured to allow for easy closure (i.e., one-handed operation) while still providing a sufficiently strong seal between the cap and the lid to prevent sample leakage from container 16 during, for example, reverse centrifugation.

[0089] like Figures 2A to 2CAs shown, the blood collection container 16 of this disclosure includes a container body 110 defining an interior 112 configured to receive a blood sample from a port 26 of a holder 12. The container body 110 includes an upper portion 114 or cap with an opening or partial opening at the top 116, and a closed bottom 120 (as shown). Figures 4A to 4C The lower portion 118 (also referred to herein as the base or body) is shown. In some examples, the upper portion 1114 and the lower portion 118 are integrally formed and / or non-removably attached together by means of, for example, adhesive or ultrasonic welding.

[0090] In other examples, such as Figures 4A to 4D As most clearly shown, the upper portion 114 or cap and the lower portion 118 are separate components that can be detachably connected together and can be disassembled, for example, by twisting the upper portion 114 or cap relative to the lower portion 118 and / or by axially pulling the upper portion 114 or cap away from the lower portion 118. In some examples, the lower portion 118 of the container body 110 may include a closed bottom 120, a lower portion open top 122, and a lower portion annular sidewall 124 extending between the closed bottom and the lower portion open top. Similarly, the upper portion 114 or cap may include an open bottom 126 inserted into the open top 122 of the lower portion 118, an upper portion open top 116, and an upper portion annular sidewall 128 extending between the open bottom and the upper portion open top.

[0091] The sample collection container 16 also includes a lid 130, which includes a lid body 132, a flexible connector such as a hinge 134 or a movable hinge, a permeable diaphragm 136, and a latch 138. The flexible connector or hinge 134 connects the lid body 132 to the upper portion 114 or cap of the container body 110. The hinge 134 is a flexible member configured to open and close, such that in the closed position (e.g., as shown in the image), the lid body 132 is connected to the upper portion 114 or cap of the container body 110. Figure 2B (as shown) and the opening position (e.g., Figure 2A The lid 130 can be moved between the closed and open positions (as shown in the diagram), where it covers the upper portion 114 or the top of the opening 116 of the cap, and in the open position, it is uncovered. Various configurations of the flexible connector or hinge 134, which may be formed of rigid or semi-rigid materials, will be known to those skilled in the art and are suitable for use with the collection container 16 of this disclosure. For example, the hinge 134 may be an elongated member including one or more notches or scribbles that provide a bending point for the hinge 134. The hinge 134 is configured to pivot or unfold about the bending point, thereby allowing the lid 130 to switch between a closed and an open position.

[0092] like Figure 2C As most clearly shown, a permeable diaphragm 136 is mounted on the lid body 132 and seals the top 116 of the opening in the upper portion 114 when the lid 130 is in the closed position. A latch 138 extends from the lid body 132 and engages a protrusion or latch 140 on the upper portion 114 of the container body 110 or the cap when the lid 130 is in the closed position to ensure that the lid 130 remains in the closed position.

[0093] One advantage of the latch 138 is that it helps align the upper portion 114 or the top 116 of the cap opening with the diaphragm 136 even when the user attempts to close the lid 130 with one hand. Therefore, the latch 138 advantageously prevents errors caused by incorrect alignment of the lid 130 with the container body 110. The latch 138, diaphragm 136, and flexible connector or hinge 134 of the lid 130 of this disclosure also contribute to forming a secure engagement between the lid 130 and the container body 110. The inventors have recognized that the lid 130 of the container 16 may be subjected to several different types of loads during normal use of the container 16 and / or during anticipated or possible misuse, thus requiring easy closure and a secure engagement. The lid 130 and latch 138 of this disclosure are configured to overcome such loads, such that the lid 130 remains in the closed position protecting the blood sample contained in the container 16. For example, during automated processing, forces may be applied to the lid 130 and / or latch 138 as the collection container 16 (in the inverted or lid-down direction) enters the centrifuge well from a distance of approximately 4 inches to approximately 18 inches. During automated processing by the blood analyzer instrument, the collection container 16 may also be subjected to forces during loading, torsion, and / or impact. The collection container 16 may also be subject to accidental drops by the user, where the user may drop the collection container 16 a vertical distance far greater than 18 inches. Forces may also be applied to the lid 130 and / or latch 138 during loading, unloading, and / or transport from the sample collection site to the laboratory. For example, forces may be applied to the lid 130 and / or latch 138 when the aspiration needle passes through the punctureable septum 136, which could pull the lid 130 away from the upper portion 114 or cap of the container body 110. The latch 138 also acts as a tamper-evident system to prevent accidental opening and spillage of blood from the collection container 16.

[0094] Refer again Figures 2A to 2CIn some examples, the latch 138 includes a frame 142 that defines an opening 144 that receives the latch 140 of the upper portion 114 or cap when the lid 130 is in the closed position. For example, the opening 144 may be a square or rectangular opening 144 sized to receive a similarly sized square or rectangular protrusion extending radially outward from the outer surface of the sidewall 128 of the upper portion 114 or cap. In some examples, the latch 140 includes a sloped or ramped surface 146 positioned such that, when the lid 130 changes between an open and closed position, the latch 138 deflects on the latch 140 with the aid of the sloped surface 146 and then quickly returns to position to engage the latch 140. The frame 142 of the latch 138, as well as the lid body 132 and hinge 134, can be integrally formed, for example, by injection molding from a rigid or semi-rigid material (e.g., hard plastic, i.e., polypropylene).

[0095] The latch 138 also includes a cushioning pad 148 or spacer positioned on or near the leading edge 150 of the frame 142 of the cover 130. The cushioning pad 148 is provided to limit the easy and / or accidental disengagement of the latch 138 from the latch 140. As used herein, a restraining structure such as a cushioning pad “restrains” another structure (i.e., the latch 138) from disengagement when additional force, time, or a more complex action is required to cause disengagement compared to the absence of a restraining structure. In particular, it should be understood for the purposes of this disclosure that the cushioning pad 148 does not completely prevent the latch 138 from disengaging from the latch 140. Rather, as described in more detail herein, the cushioning pad 148 makes it more difficult for a user to disengage the latch 138 from the latch 140 compared to the absence of a cushioning pad, meaning that accidental release of the latch 138 is less likely.

[0096] The cushioning pad 148 may be formed of a flexible material (i.e., a material more flexible than the material used to form the frame 142, flexible connectors or hinges 134, and / or the container body 110). For example, the cushioning pad 148 may be formed of a thermoplastic elastomer. The diaphragm 136 may also be formed of a thermoplastic elastomer, such as liquid silicone rubber (LSR), polyurethane rubber, latex rubber, etc. In other examples, the cushioning pad 148 and / or the diaphragm 136 may be formed of other flexible elastic materials such as silicone.

[0097] When the cover 130 is moved to the closed position, the rigidity of the frame 142 serves to secure the latch 138 to the latch 140. Specifically, the latch 138 can be configured to function as a cantilever beam, meaning that the latch 138 bends on the latch 140 and then snaps into place, creating a strong engagement between the latch 138 and the latch 140. The cushioning pad 148 acts as an anti-tampering mechanism. In particular, the cushioning pad 148 on the leading edge 150 of the latch 138 makes it more difficult for a user (i.e., the user's fingers or some unintentional removal tool) to obtain sufficient leverage to pry open the latch 138 by preventing any space where a user's fingernails or tools could be inserted to pry open the latch 138. Advantageously, with the cushioning pad 148 present, it is virtually impossible for a user to insert a gloved hand under the latch 138 to obtain sufficient leverage to release the latch 138, making accidental opening less likely in a medical setting. To release latch 138, a specially manufactured removal tool may be provided, sized to allow insertion beneath buffer pad 148 to release latch 138. The provision of a cover 130 and latch 138 that can only be easily opened using a specific and specially designed removal tool ensures that cover 130 can only be opened in a controlled and purposeful manner.

[0098] Another advantage of the cushioning pad 148 is that it increases the flexibility of the latch 138 compared to the absence of the cushioning pad 148. Specifically, because of the presence of the cushioning pad 148 on the latch 138, the frame 142 of the latch 138 can be quite thin without the risk of breakage. The combination of the thin frame 142 and the flexible cushioning pad 148 means that the latch 138 can easily bend in a rearward direction (i.e., radially away from the container body 110). Due to this inherent flexibility of the latch 138, during closing, the latch 138 easily deflects on the latch 140 with the aid of the inclined or ramped surface 146 of the latch 140, and then quickly returns to the position engaged with the latch 140. Therefore, the cushioning pad 148 also contributes to the easy one-handed closing provided by the lid 130 and the latch 138 of this disclosure.

[0099] In some examples, the lid body 132 may include an annular flange 152 that defines an opening 154. For example... Figure 2CAs shown, the diaphragm 136 is inserted into the opening 154, wherein the annular flange 152 is received within the annular recess 156 of the diaphragm 136. The diaphragm 136 is configured to press into the opening top 116 of the upper portion 114 or the cap of the container body 110, thereby sealing the blood collection container 16 when the cap 130 is in the closed position. As previously described, the engagement between the diaphragm 136 and the opening top 116 of the upper portion 114 is designed to provide a robust seal sufficient to overcome the forces exerted on the diaphragm 136 and / or the sample collection container 16 during reverse centrifugation. To generate a robust seal, the inner diameter of the opening top 116 of the upper portion 114 and the outer diameter of the diaphragm 136 are selected to control the initial closing force required to close the cap 130 and the initial sealing pressure provided by the diaphragm 136. The geometry and inherent flexibility of the diaphragm 136 also contribute to the high-pressure sealing performance of the diaphragm 136 during reverse centrifugation. In particular, the initial interference between the top 116 of the opening in the upper portion 114 and the diaphragm 136 (i.e., outer diameter minus inner diameter) was optimized to allow for both easy closing force and sufficient initial sealing pressure within tolerance.

[0100] In some examples, the diaphragm 136 may include an inward-facing surface 158 and an outward-facing surface 160, the inward-facing surface facing the interior 112 of the container body 110, and the outward-facing surface opposite the inward-facing surface 158. In some examples, the inward-facing surface 158 of the diaphragm 136 includes a chamfered peripheral edge 162. As used herein, a “chamfered” edge is an inwardly angled, tapered, or tapered edge designed to facilitate insertion of the diaphragm 136 into the container body 110. In some examples, the chamfered edge 162 includes a ring-shaped angled surface. In other examples, such as Figure 2C As shown, the chamfered edge 162 is an annular curved surface. Similarly, the upper portion 114 of the container body 110 or the cap may include an annular chamfered edge 164 positioned to contact the outer edge 162 of the chamfer of the diaphragm 136 when the cap 130 is moved to the closed position. The size and construction of the annular chamfered edge 164 of the upper portion 114 or the cap are designed to deform the diaphragm 136 when the cap 130 is in the closed position, thereby sealing the interior 112 of the container body 110.

[0101] The chamfered edges 162, 164 also contribute to a low closing force at the interface between the lid 130 and the container body 110, allowing for one-handed closure without any tools. Specifically, the shape and position of the chamfered edges 162, 164 are designed to easily slide against each other, resulting in minimal pressure required to close the lid 130. The latch 138 also helps ensure a proper seal by providing visual confirmation of the appropriate insertion depth of the diaphragm 136 into the container body 110. In particular, the user can see and often hear the opening 144 of the latch 138 engaging and / or locking to the latch 140.

[0102] When the diaphragm 136 is inserted into the container body 110 to the appropriate sealing depth, the diaphragm 136 is able to “grow rapidly” when the high pressure of reverse centrifugation is applied to the diaphragm 136. Rapid growth refers to the deformation of the diaphragm 136, wherein portions of the diaphragm 136 move radially outward, contacting and pressing against the sidewall 128 of the upper portion 114 to provide a reinforced seal between the diaphragm 136 and the container body 110. In some examples, the geometry of the diaphragm 136 also contributes to the rapid growth effect that occurs during centrifugation. For example, the inward-facing surface 158 of the diaphragm 136 may include or define a central cavity 166 that enhances the radial deformation of the diaphragm 136 during centrifugation. The central cavity 166 can be any shape that increases or enhances the radial flexibility of the peripheral portion of the diaphragm 136. For example, as Figure 2C As shown, cavity 166 includes a conical surface, such as a conical annular surface forming a conical or V-shaped cavity. The conical or V-shaped geometry of cavity 166 of diaphragm 136 allows the flexible material of diaphragm 136 to bend outward to increase sealing pressure when diaphragm 136 is exposed to the high g-force of reverse centrifugation. Specifically, as container 16 is positioned in the centrifuge with an inverted or cap-first orientation, the fluid contents in the interior 112 of container body 110 are pressed against diaphragm 136 due to gravity and the gravitational forces generated during centrifugation. These forces cause the peripheral portion of diaphragm 136 to flex or bend radially outward against the rigid sidewall 128 of upper portion 114 or the cap of container body 110, thereby causing diaphragm 136 to take on a mushroom shape and enhancing the engagement between diaphragm 136 and sidewall 128. This mushroom-shaped or expanded diaphragm 136 increases sealing pressure, which prevents sample leakage from container 16. The radial expansion of diaphragm 136 is caused by Figure 3A and Figure 3B The finite element analysis model is shown in the figure. Figure 3A and Figure 3B As shown, the sealing force of the diaphragm 136 increases significantly with the increase of fluid pressure applied to the inward-facing surface 158 of the diaphragm 136. For example, as... Figure 3A As shown, under low pressure (i.e., after assembly), the diaphragm's sealing force is approximately 48 pounds per square inch (psi). Figure 3B As shown, when a fluid pressure of 120 psi is applied to the diaphragm 136, the sealing force increases to 205 psi.

[0103] Continue to refer to Figures 2A to 2C The outward-facing surface 160 of the diaphragm 136 may include a recess or well 168 positioned to collect any fluid escaping from the interior 112 of the container body 110, for example, during the retraction of the needle through the diaphragm 136. More specifically, the recess or well 168 may be a blood splash well. The well 168 may be configured such that any residual blood escaping during needle retraction is contained within the recessed blood splash well 168. Thus, residual blood is not presented as a surface in direct contact, thereby limiting blood exposure in a laboratory environment.

[0104] As is known in the art, sealing structures formed of flexible materials (e.g., thermoplastic elastomers) can develop compression permanents when kept under pressure for extended periods. While this may be a disadvantage for long-term sealing, the diaphragm 136 of this disclosure is not typically kept under pressure for most of its usable lifespan. Instead, the diaphragm 136 is only expected to be under stress during a single use, particularly after a blood sample has been collected and the cap has been closed. Therefore, the total duration for which the diaphragm 136 is expected to be under pressure (including during reverse centrifugation) is approximately 48 hours. It is believed that the diaphragm 136 will not become compressibly deformed and / or lose its sealing ability within such a short time. Furthermore, it is believed that when used as a disposable product, the material and geometry of the diaphragm 136 of this disclosure allow the diaphragm 136 to utilize the inherent flexibility of materials such as thermoplastic elastomers to provide enhanced sealing for the container 16, particularly during reverse centrifugation, without suffering from the problems associated with compression permanents over time.

[0105] The flexible material (i.e., thermoplastic elastomer) of the diaphragm 136 can be readily processed by injection molding. Advantageously, the features of the diaphragm 136 (e.g., wells 168, cavities 166, and notches 156) are formed without grooves, allowing for simple injection molding for production. Furthermore, the injection-molded material can be bonded to a semi-rigid substrate (e.g., to the cap body 132), thereby connecting the cap body 132 to the diaphragm 136. This connection between the diaphragm 136 and the cap body 132 provides a robust and easily manufactured component that can be produced in large quantities with minimal assembly requirements. While other materials could also be used to form the cap body 132 and / or the diaphragm 136, the cap 130 formed from most other materials would likely require assembly and / or bonding of rigid / flexible components, resulting in a more expensive production process. For example, silicone materials would offer excellent flexibility and exhibit less compression set behavior compared to the thermoplastic elastomer materials described herein. However, since the silicone does not bond with the cap body 132 or frame 142 formed of polypropylene, it will be more difficult to produce the silicone diaphragm 136 by injection molding.

[0106] Another advantage of the sample collection container 16 of this disclosure is the integration of the diaphragm 136 with the lid 130. Similarly, the lid 130 and latch 138 are integrated with the container body 110 via hinge 134. This structure allows for the construction of a single component, which is considered advantageous compared to devices or assemblies formed by multiple loose parts. In particular, loose parts may be lost or dropped by the user, or (in the case of O-rings) require additional assembly steps during manufacturing. Furthermore, as provided by the diaphragm 136 of this disclosure, O-rings do not allow for increased sealing pressure during reverse centrifugation.

[0107] While a seal between the lid 130 and the container body 110 could also be achieved using two rigid materials (i.e., face-to-face contact between the opposing polypropylene structures of the lid 130 and the container body 110), such an engagement between rigid materials would require a high closing force or closing method (e.g., threaded or bayonet connection) to provide the user with a mechanical advantage in forcing the lid 130 to the closed position. If threads are used, the lid 130 would need to rotate freely relative to the container body. In this case, the lid 130 would need to be a separate component from the container body 110. While the lid 130 could be attached to the container body 110, for example, by a tether, such an arrangement would be more difficult to assemble than the integrated container 16 of this disclosure. Therefore, the inventors believe that the container 16 of this disclosure, comprising an integrated lid 130, diaphragm 136, and latch 138, offers advantages over other types of lids and closures known in the art.

[0108] Sample collection container with a detachable container body

[0109] Reference Figures 4A to 4D The upper portion 114 or cap of the container body 110 can be separable from and / or detachably attached to the lower portion 118 of the container body 110. The connection interface between the upper portion 114 or cap and the lower portion 118 can be configured to provide easily guided assembly (i.e., axial press-fit connection), radial orientation of the components (i.e., radial orientation of the upper portion 114 or cap relative to the lower portion 118), reliable liquid and gas tight seals between portions 114 and 118, and controlled disassembly during cap removal using a dedicated cap removal tool.

[0110] like Figure 4C and Figure 4D As shown, the upper portion 114 or cap is sized to press against the lower portion 118 with an overlap distance D1. As used herein, "overlap distance" refers to the maximum distance at which the upper portion 114 or cap overlaps with the top 122 of the lower portion 118 when the upper portion 114 or cap is fully positioned on the lower portion 118. In this fully positioned position (i.e., at the overlap distance D1), the upper portion 114 is restricted from rotating relative to the lower portion 118. As used herein, rotation of the first structure relative to the second structure is "restricted" when certain components of the first and / or second structures make rotation of these structures relative to the other structure more difficult than if that component were not present. For example, the first and / or second structures may include protrusions, grooves, pawls, angled surfaces, threads, and any other components that make rotation of one structure relative to the other more difficult. While the user can still rotate the first structure relative to the second structure, sufficient force is required to overcome any engagement between the first and second structures, which is provided, for example, by protrusions, grooves, pawls, angled surfaces, threads, or other components.

[0111] The upper portion 114 or cap of the container body 110 is intended to be securely connected to the lower portion 118 to protect blood samples within the interior 112 of the container body 110. Furthermore, the inventors believe that the connection or interface between portion 114 and portion 118 needs to be sufficiently reliable and robust to withstand foreseeable misuse, preventing leakage or separation of the upper portion 114 or cap from the lower portion 118 at inappropriate or accidental times. Where appropriate, the connection or interface between the upper portion 114 or cap and the lower portion 118 should be easily overcome in a controlled manner, allowing the user easy access to the blood sample contained within the interior 112 of the container body 110. As described in more detail below, this robust and secure connection is achieved through a tapered interference fit sealing connection combined with a cam or bevel, providing a mechanical advantage for separation of the upper portion 114 or cap from the lower portion 118. Advantageously, the connection or engagement interface of this disclosure is intended to be easy to assemble and includes components for controlling radial orientation. The upper part 114 or cap is not easily separated from the lower part 118, which means that it is difficult for the user to accidentally separate the upper part 114 or cap from the lower part 118 at an inappropriate time.

[0112] In some examples, such as Figures 4A to 4D As shown, the lower portion 118 of the container body 110 includes an annular flange 170 extending radially outward from the outer surface 172 of the annular sidewall 124 of the lower portion 118. The annular flange 170 can be configured such that when the upper portion 114 is inserted into the lower portion 118, the bottom 126 of the opening of the upper portion 114 or the cap contacts the annular flange 170 of the lower portion 118 to limit rotation of the upper portion 114 relative to the lower portion 118. In some examples, the rotation of the upper portion 114 or the cap relative to the lower portion 118 is controlled by cams or ramps 174a, 174b on the annular flange 170 (e.g., Figures 4A to 4C (As shown) and the corresponding cams or ramps 176a, 176b on the upper part 114 or the bottom 126 of the cap (as shown) Figures 4A to 4C The limitations of the joint between (shown). The ramps 174a, 174b, 176a, 176b are also configured to help control the radial orientation of the upper portion 114 or cap relative to the lower portion 118 during assembly.

[0113] More specifically, in some examples, the annular flange 170 extending from the lower portion 118 includes a first bevel 174a angled in a first direction and a second bevel 174b angled in a second direction. The upper portion 114 or the bottom 126 of the cap includes corresponding bevels (e.g., a first bevel 176a and a second bevel 176b) configured to axially align with the bevels 174a, 174b of the lower portion 118 when the upper portion 114 is inserted onto the lower portion 118. In some examples, the first bevel 174a and the second bevel 174b are adjacent to each other, forming a crown or peak 178 pointing toward the top 122 of the lower portion 118. The bevels 176a, 176b on the bottom 126 of the upper portion 114 also form peaks positioned to align with the peaks 178 of the annular flange 170. In some examples, the annular flange 170 and the upper portion 114 or the bottom portion 126 of the cap may include a plurality of peaks 178, such as two peaks located on opposite sides of the annular flange 170. In other examples, the annular flange 170 and the upper portion 114 or the bottom portion 126 of the cap may include more than two peaks, such as four peaks located at 0 degrees, 90 degrees, 180 degrees, and 270 degrees around the annular flange 170 and / or the bottom portion 126.

[0114] In some examples, ramps 174a, 174b, 176a, 176b are not only positioned to restrict rotation of portions 114, 118, but also facilitate the separation of the upper portion 114 or cap from the lower portion 118 of the container body 110. For example, ramps 174a, 174b, 176a, 176b can be positioned such that a small (i.e., a quarter turn) rotation of the upper portion 114 or cap relative to the lower portion 118 causes ramps 176a, 176b of the upper portion 114 to slide along ramps 174a, 174b of the annular flange 170 of the lower portion 114, thereby lifting the upper portion 114 from the lower portion 118. Thus, ramps 174a, 174b, 176a, 176b provide a mechanical advantage to control disassembly during cap removal. Specifically, with the lower portion 118 of the container body 110 fixed, rotation of the upper portion 114 or the cap causes the ramps 174a, 174b to push the upper portion 114 or the cap axially away from the lower portion 118, beyond any axial retaining feature, thereby releasing the upper portion 114 from the lower portion 118. Once the upper portion 114 has moved beyond any axial retaining feature, the upper portion 114 or the cap can be completely removed with very little force, for example, by grasping the upper portion 114 or the cap and moving it axially away from the container body 110.

[0115] Therefore, it should be understood that after a small rotation of the upper portion 114 or cap (i.e., a quarter turn), the upper portion 114 or cap does not completely detach from the lower portion 118. Instead, even a small rotation, for example by a gloved user (i.e., with the force of gloved fingertips), will release the upper portion 114 or cap from the lower portion 118, making it easily detachable. Furthermore, due to the relatively simple release technique, it is believed that the fluid contents (i.e., the blood sample) in the container 16 will not be disturbed during the release action by rapid or sudden movements that could, for example, cause spillage.

[0116] It should be recognized that the upper portion 114 or cap can also be connected to the lower portion 118 via other mating interfaces known in the art, such as threaded connections or Luer lock connections. However, while a conventional threaded connection will connect and seal the interface between the upper portion 114 or cap and the lower portion 118, it does not allow for controlled orientation of the upper portion 114 or cap relative to the lower portion 118. Furthermore, installing a conventional threaded connection in a high-speed assembly production environment is less straightforward compared to the axially pressed connection of this disclosure. Additionally, users may easily damage a conventional threaded connection at inappropriate times during the product's lifespan. In contrast, the connection interface between the upper portion 114 or cap and the lower portion 118 of this disclosure allows for simple assembly in high-speed automated production and a robust connection that is not easily damaged by the user.

[0117] In some examples, the engagement between the upper portion 114 or cap of the container body 110 and the lower portion 118 can be further enhanced by protrusions, extensions, textured areas, and / or similar protruding structures extending from the surface of the sidewalls of the upper portion 114 or cap and / or from the sidewalls of the lower portion 118. For example, as Figure 4C and Figure 4DAs shown, the lower portion 118 of the container body 110 may include an annular protrusion 180 extending radially outward from the outer surface 172 of the annular sidewall 124 of the lower portion 118. The inner surface 182 of the upper portion sidewall 128 may include an annular groove 184 that receives the annular protrusion 180 of the lower portion 118. The shape of the annular protrusion 180 may be designed to facilitate sliding the upper portion 114 or cap onto the lower portion 118. For example, the annular protrusion 180 of the lower portion 118 may include an inclined upper surface 186a, a substantially flat lower surface 186b, and a cylindrical peripheral edge 186c extending between the inclined upper surface and the substantially flat lower surface. The inner surface 182 of the upper portion 114 or cap is configured to slide along the inclined upper surface 186a of the annular protrusion 180, pushing the sidewall 128 of the upper portion 114 or cap slightly radially outward to facilitate the insertion of the lower portion 118 into the upper portion 114.

[0118] In some examples, the engagement between the upper portion 114 or cap and the lower portion 118 is further enhanced by providing a slight taper to the lower portion sidewall 124 near the top 122 of the lower portion 118. For example, the sidewall 124 of the lower portion 118 may include a tapered portion 188 that tapers radially outward toward the opening top 122 of the lower portion 118. The tapered portion 188 may be configured to provide a tapered interference fit between the outer surface 172 of the lower portion sidewall 124 and the inner surface 182 of the upper portion sidewall 128. To provide this tapered interference fit, the tapered inner diameter of the upper portion 114 or cap and the tapered upper portion diameter of the lower portion 118 are selected to allow for simple axial press-fit assembly. Furthermore, the tapered geometry may allow for axial alignment during assembly, thereby guiding the two portions 114, 118 of the container body 110 together.

[0119] In some examples, the upper portion 114 or cap may also include one or more reinforcing ribs 190 extending from the outer surface 194 of the sidewall 128 of the upper portion 114. For example, the reinforcing rib 190 may be an annular rib or an area of ​​increased thickness, which increases the overall stiffness of the upper portion 114. This increased stiffness of the upper portion 114 is believed to provide a more robust connection between portion 114 and portion 118. The axial length of the tapered portion 188 or sealing area and the annular flange 170 on the lower portion 118 also contribute to making the interface between portion 114 and portion 118 more rigid and preventing wobbling. It is believed that at least these features contribute to strengthening the interface between portion 114 and portion 118 and maintaining sealing pressure throughout the entire shelf life of the collection container 16, as well as resisting creep and material relaxation over time. Conversely, a simple annular bead / belt on one of the portions 114 and 118 would provide a seal but would not provide a robust mechanical connection to withstand use / abuse, eliminate wobbling, and maintain a liquid-tight / air-tight seal. Furthermore, compared to providing a simple tapered interference fit feature, annular bead / belts would be a slotted feature in injection molding tools and would require tight tolerances and / or complex tooling during production.

[0120] Disassembly tools used to separate the various parts of the container body

[0121] In some examples, the upper portion 114 or cap and / or lower portion 118 of the container body 110 includes features for using specially designed or selected tools to aid in cap removal. For example, the upper portion 114 or cap may include U-shaped ribs 192 (such as...). Figures 4A to 4C (As shown), these U-shaped ribs engage with a tool to provide a mechanical advantage during a small (i.e., quarter-turn) rotation to release the upper portion 114. The U-shaped ribs 192 can be relatively shallow, so that the user will not attempt to grasp the U-shaped ribs 192 to try to release the upper portion 114 using his or her fingers instead of the tool. However, the U-shaped ribs 192 should be deep enough to transmit sufficient torque from the tool to the upper portion 114 or cap when the U-shaped ribs 192 are contacted by a specific tool to release the upper portion 114 or cap from the lower portion 118. Furthermore, ideally, the tool can be configured to ensure that the interface between the cap 130 and the top 116 of the upper portion 114 or cap is stress-free, so that the seal between the diaphragm 136 of the cap 130 and the top 116 of the upper portion 114 or cap is not broken during cap removal operations.

[0122] Figures 5A to 5DA cap removal assembly 210 incorporating features of this disclosure is shown for removing the upper portion 114 or cap of a blood collection container 16 from the container body 110 or lower portion 118. Assembly 210 includes features designed to make cap removal operation very simple and effortless, and also prevents accidental cap removal during use (blood collection and processing).

[0123] Component 210 includes a support 212 configured to support the blood collection container 16 in an upright position and restrict rotation of the container 16 relative to the support 212. For example, the support 212 may be a tubular structure including a closed bottom or base 214 and an open top 216. The open top 216 may be sized such that the collection container 16 can be securely inserted into the support 212 through the open top 216. In some examples, ribs (not shown) may also be present on the bottom 120 of the lower portion 118 of the collection container 16, which (when inserted into the support 212) engage anti-rotation structures of the support 212 to prevent rotation of the container 16 relative to the support 212 during cap removal. Ideally, these ribs are positioned so that they are not easily accessible to the user, making it unlikely that the user will attempt to grasp these ribs or use them to apply torque to detach the upper portion 114 or cap from the lower portion 118. Conversely, the ribs on the bottom 120 are ideally positioned so that they are easily engaged only by corresponding structures on the support 212.

[0124] The cap removal assembly 210 also includes a tool 218 having a cap remover 220 and a handle 222 extending from the cap remover. The cap remover 220 includes a body and at least one protrusion (e.g., a fork 226) defining an opening 224 or recess sized to receive the cap or upper portion 114 of the blood collection container 16. The at least one protrusion extends from the body to the opening 224 or recess, which is positioned to engage the upper portion 114 or a portion of the cap. For example, the fork 226 may be positioned to engage and / or insert into a U-shaped rib 192 of the upper portion 114. Once the tool 218 is engaged with the upper portion 114 or cap, the user can apply a rotational force to the handle 222 of the tool 218 in the direction of arrow A1 (e.g., ...). Figure 5E (As shown) the upper portion 114 or cap rotates relative to the lower portion 118. As previously described, the interface between the upper portion 114 or cap and the lower portion 118 is configured such that the upper portion 114 or cap is released from the lower portion 118 with a small amount of rotation (i.e., a quarter turn). Once the upper portion 114 or cap is released from the lower portion 118 of the container body 110, the upper portion 114 or cap can be removed by axially lifting the upper portion 114 or cap from the lower portion 118.

[0125] In some examples, the body of tool 218 is a ring 228 that defines an opening 224 (i.e., a through-hole or drilled hole extending through the ring 228). In some examples, cap remover 220 includes two protrusions (e.g., two forks 226) that extend from the inner surface of the ring 228 into the opening 224. The forks 226 are positioned and sized to contact the upper portion 114 of container 16 or the U-shaped rib 192 on the cap to facilitate release of the upper portion 114 or the cap from the lower portion 118. Figure 5D As shown, in some examples, the prongs 226 are positioned on opposite sides of the ring 228 such that the virtual line V1 passing between the prongs 226 passes through the center C1 of the opening 224 defined by the ring 228. Furthermore, the prongs 226 can be positioned offset from the handle 222 of the tool 218, allowing the user to grip the tool 218 more comfortably. For example, the virtual line V1 between the prongs 226 can be tilted or at a small angle relative to the longitudinal axis L1 of the handle 222, such as from about 5 degrees to about 25 degrees, preferably about 15 degrees.

[0126] To remove the upper portion 114 or the cap from the lower portion 118 of the container body 110 using the cap removal assembly 210, the user first places the collection container 16 containing the fluid sample into the holder 212, such as... Figure 5A As shown. As previously described, mechanical features are provided for the collection container 16 and / or the support 212 to limit the rotation of the collection container 16 relative to the support 212. Next, the user inserts the cap remover 220 of the tool 218 into the upper portion 114 of the collection container 16 or the cap, and moves the cap remover 220 downward until the fork 226 is received in the U-shaped rib 192, as shown. Figure 5E As shown. Once the cap remover 220 is properly positioned, the user can place his or her thumb on the upper portion 114 or the top 116 of the cap 130 to hold the collection container 16 in place and prevent it from being accidentally lifted off the holder 212. When the user's thumb is on the upper portion 114 or the top 116 of the cap, the user applies a rotational force to the handle 222 of the tool 218, as indicated by arrow A1 ( Figure 5E The cap remover 220 is rotated slightly (i.e., a quarter turn) in the direction of the lower portion 118 to release the upper portion 114 or cap from the lower portion 118. Once the upper portion 114 or cap is released from the lower portion 118, the upper portion 114 or cap can be removed by grasping the upper portion 114 or cap and moving it axially away from the lower portion 118.

[0127] In some examples, the ring 228 is sized such that the upper portion 114 or cap can be inserted into the opening 224 when the tool 218 is in an upward or downward orientation. This allows the tool 218 to be used by both right-handed and left-handed individuals. For example, the tool 218 can be configured to allow right-handed operation when in an upward orientation, meaning that a right-handed person inserts the tool 218 into the upper portion 114 or cap while the tool 218 is in an upward orientation. A left-handed person flips the tool 218 so that it is in a downward orientation and then inserts the cap remover 220 into the upper portion 114 or cap. By flipping the tool 218, a left-handed person can rotate the tool 218 in the opposite direction, which is easier for a left-handed person to perform.

[0128] Specific reference Figure 5B and Figure 5C In some examples, tool 218 may include a pressing member 230, which is mounted to handle 222 and has a distal end 232 extending over opening 224 of remover 220. The pressing member 230 is positioned to press against the upper portion 114 of container 16 or the top 116 of cap, meaning the user does not need to place his or her thumb on the upper portion 114 or cap when rotating tool 218. Similar to the user's thumb, the pressing member 230 prevents container 16 from being lifted out of holder 212 when tool 218 and the upper portion 114 or cap are rotated relative to the lower portion 118 of container body 110. Depending on whether the user is right-handed or left-handed, the pressing member 230 may be attached to the upper surface 234 or the lower surface 236 of tool 218. For example, as Figure 5C As shown, the pressing member 230 is attached to the upper surface 234 of the tool 218 so that the tool can be engaged with the container 16 in an upward orientation. To reconfigure the tool 218 for use by a left-handed person, the pressing member 230 should be removed and reattached to the lower surface 236 of the tool 218 so that the tool 218 can be inserted into the container 16 in a downward (i.e., left-handed) orientation.

[0129] While various examples of sample containers, blood collection devices, and related tools are shown in the accompanying drawings and described in detail above, other examples will be apparent to those skilled in the art and readily made by them without departing from the scope and spirit of the invention. Therefore, the above description is intended to be illustrative and not restrictive. The invention described above is defined by the appended claims, and all modifications to the invention falling within the equivalent meaning and scope of the claims are included within the scope of the claims.

Claims

1. A sample collection container configured for removable attachment to a blood collection device, the collection container comprising: A container body defining an interior configured to receive a sample provided from the blood collection device, the container body including an upper portion and a lower portion, the upper portion including an open top and the lower portion including a closed bottom; as well as A lid, the lid comprising: Lid body; A flexible connector is located between the lid body and the upper portion of the container body. The flexible connector moves the lid between a closed position and an open position. In the closed position, the lid covers the top of the opening of the upper portion, and in the open position, the top of the opening of the upper portion is not covered. A puncture-resistant diaphragm, attached to the lid body, which, when the lid is in the closed position, seals the top of the opening in the upper portion; and A latch extending from the lid body engages with a latch on the upper portion of the container body to secure the lid in the closed position; the latch includes a cushioning pad positioned to restrict insertion of fingers or tools below the latch, thereby preventing the latch from disengaging from the latch.

2. The collection container according to claim 1, wherein, The latch includes a frame formed of a first material and a cushioning pad formed of a second material, the second material having a lower rigidity than the first material.

3. The collection container according to claim 2, wherein, The cushioning pad is positioned near the front edge of the frame of the lid.

4. The collection container according to claim 2, wherein, The frame includes an opening that receives the latch of the upper portion when the lid is in the closed position, and wherein the cushioning pad is positioned between the opening of the frame and the front edge of the frame.

5. The collection container according to claim 2, wherein, The lid body, the flexible connector, and the container body all comprise the first material, and the diaphragm comprises the second material.

6. The collection container according to claim 2, wherein, The first material is a semi-rigid plastic, and the second material is a thermoplastic elastomer.

7. The collection container according to claim 6, wherein, The first material is polypropylene, and the second material is at least one of liquid silicone rubber, polyurethane rubber, and latex rubber.

8. The collection container according to claim 1, wherein, The latch of the upper portion of the container body includes a ramp surface that is positioned such that when the lid is switched between the open and closed positions, the latch deflects onto the latch before engaging the latch.

9. The collection container according to claim 1, wherein, The diaphragm includes an inward-facing surface facing the interior of the container body and an outward-facing surface opposite the inward-facing surface. The outward-facing surface includes grooves or wells positioned to collect any fluid escaping from the interior of the container body during needle retraction through the diaphragm.

10. The collection container according to claim 1, wherein, The lid body includes an annular flange defining an opening, wherein the diaphragm is inserted into the opening and the annular flange is received within an annular recess of the diaphragm.

11. The collection container according to claim 1, wherein, The diaphragm includes an inward-facing surface that faces the interior of the container body when the lid is in the closed position, and the inward-facing surface of the diaphragm includes a chamfered outer edge.

12. The collection container according to claim 11, wherein, The inward-facing surface of the diaphragm defines a central cavity that enhances the radial deformation of the diaphragm during centrifugation.

13. The collection container according to claim 12, wherein, The central cavity includes a conical annular surface.

14. The collection container according to claim 1, wherein, The top of the opening in the upper portion includes an annular chamfered edge, which is positioned to contact the chamfered outer edge of the diaphragm when the lid is moved to the closed position.

15. The collection container according to claim 14, wherein, When the lid is in the closed position, the annular chamfered edge of the upper portion deforms the diaphragm, thereby sealing the interior of the container body.

16. The collection container according to claim 15, wherein, The diaphragm is configured to expand radially during centrifugation, thereby enhancing the sealing of the interior of the container body.

17. The collection container according to claim 1, wherein, The lower portion of the container body is detachable from and removably attached to the upper portion of the container body.

18. The collection container according to claim 17, wherein, The upper portion is sized to press against the lower portion, and when the upper portion is fully positioned on the lower portion, the upper portion is restricted from rotating relative to the lower portion.

19. The collection container according to claim 1, wherein, The lower portion of the container body includes a closed bottom, an open top, and an annular sidewall extending between the closed bottom and the open top. The upper portion of the container body includes an upper portion opening bottom inserted into the top of the lower portion opening of the container body, the opening top of the upper portion, and an upper portion annular sidewall extending between the upper portion opening bottom and the opening top of the upper portion.

20. The collection container according to claim 19, wherein, The lower portion of the container body includes an annular flange extending radially outward from the outer surface of the annular sidewall of the lower portion, wherein when the upper portion is inserted into the lower portion, the bottom of the opening of the upper portion contacts the annular flange of the lower portion to restrict rotation of the upper portion relative to the lower portion.

21. The collection container according to claim 20, wherein, The annular flange extending from the lower portion and the bottom of the opening of the upper portion include corresponding bevels, which are configured to be axially aligned when the upper portion is inserted into the lower portion.

22. The collection container according to claim 21, wherein, The rotation of the upper portion relative to the lower portion causes the inclined surface of the upper portion to slide along the inclined surface of the annular flange of the lower portion, thereby lifting the upper portion away from the lower portion.

23. The collection container according to claim 21, wherein, The lower portion includes an annular protrusion extending radially outward from the outer surface of the annular sidewall of the lower portion, and wherein the inner surface of the annular sidewall of the upper portion includes an annular groove receiving the annular protrusion of the lower portion.

24. The collection container according to claim 23, wherein, The annular protrusion extending from the lower portion includes an inclined upper surface, a generally flat lower surface, and a cylindrical peripheral edge extending between the inclined upper surface and the generally flat lower surface.

25. The collection container according to claim 21, wherein, The inner surface of the lower annular sidewall includes a tapered portion that tapers radially inward from the top of the lower opening.

26. The collection container according to claim 25, wherein, There is a tapered interference fit between the outer surface of the lower annular sidewall and the inner surface of the upper annular sidewall.

27. The collection container according to claim 1, wherein, The flexible connector includes a hinge.

28. A blood collection container, the blood collection container comprising: A container body, the container body including a closed bottom, an open top, and an annular sidewall extending between the closed bottom and the open top; A cap, the cap being an upper portion separable from the container body, the cap including a cap opening bottom that is removably inserted into the top of the opening of the container body, a cap opening top, and a cap annular sidewall extending between the cap opening bottom and the cap opening top; as well as A lid, removably mounted on top of the cap opening, wherein the cap is sized to press against the container body and, when fully seated on the container body, is restricted from rotation relative to the container body, the lid comprising... Lid body; A flexible connector is located between the lid body and the upper portion of the container body. The flexible connector moves the lid between a closed position and an open position. In the closed position, the lid covers the top of the opening of the upper portion, and in the open position, the top of the opening of the upper portion is not covered. A puncture-resistant diaphragm, mounted to the lid body, which, when the lid is in the closed position, seals the top of the opening in the upper portion; and A latch extending from the lid body engages with a latch on the upper portion of the container body to secure the lid in the closed position. The latch includes a cushioning pad positioned to restrict insertion of fingers or tools below the latch, thereby preventing the latch from disengaging from the latch.

29. A blood collection assembly, the blood collection assembly comprising: A finger retainer, the finger retainer comprising a finger receiving portion and an actuating portion; A container engagement portion, which is connected to the retainer; as well as A collection container, removably connected to the container engagement portion, the container including a container body and a lid, the container body defining an interior configured to receive a sample provided from a blood collection device, the container body including an upper portion and a lower portion, the upper portion including an open top, the lower portion including a closed bottom, and the lid including: Lid body; A flexible connector is located between the lid body and the upper portion of the container body. The flexible connector moves the lid between a closed position and an open position. In the closed position, the lid covers the top of the opening of the upper portion, and in the open position, the top of the opening of the upper portion is not covered. A puncture-resistant diaphragm, attached to the lid body, which, when the lid is in the closed position, seals the top of the opening in the upper portion; and A latch extending from the lid body engages with a latch on the upper portion of the container body to secure the lid in the closed position. The latch includes a cushioning pad positioned to restrict insertion of fingers or tools below the latch, thereby preventing the latch from disengaging from the latch.

30. A cap removal assembly for removing the cap of the blood collection container according to claim 28 from the container body of the blood collection container, the cap removal assembly comprising: A support, configured to support the blood collection container in a vertical position and restrict rotation of the blood collection container relative to the support; as well as A tool comprising a cap remover and a handle extending from the cap remover, the cap remover including a body and at least one protrusion, the body defining an opening or recess sized to receive a cap of the blood collection container, the at least one protrusion extending from the body to the opening or recess, the opening or recess being positioned to engage a portion of the cap such that rotation of the tool relative to the cap releases the cap from the container body.

31. The cap removal assembly of claim 30, wherein, Once the cap is released from the container body, it can be removed from the container body by axially lifting the cap from the container body.

32. The cap removal assembly according to claim 31, wherein, The body includes a ring defining an opening, and wherein the cap is insertable into the opening when the tool is in an upward or downward orientation.

33. The cap removal assembly according to claim 32, wherein, The tool is operable with the right hand when it is in the upward orientation and with the left hand when it is in the downward orientation.

34. The cap removal assembly of claim 30, wherein, The tool further includes a pressing member mounted to the handle, the pressing member having a distal end extending over the opening of the cap remover, the pressing member being positioned to press the top of the cap when the cap is inserted into the opening, thereby preventing the container from rising from the support when the tool and the cap are rotated relative to the container body.

35. The cap removal assembly of claim 30, wherein, The cap remover includes two protrusions that extend into the opening or recess.

36. The cap removal assembly of claim 35, wherein, The two protrusions are positioned such that a virtual line passing through the center of the opening or groove between the two protrusions is inclined relative to the longitudinal axis of the handle.

37. The cap removal assembly of claim 36, wherein, The inclination ranges from 5 degrees to 25 degrees.

38. The cap removal assembly of claim 37, wherein, The tilt is 15 degrees.

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