Sample container for capillary blood collection

Abstract

The present invention aims to provide a blood collection container that prevents accidental rotation or separation of the cap, is robust and leak-resistant, and can be easily opened when necessary. [Solution] The blood collection container comprises a container body having a closed bottom portion, an open top portion, and an annular side wall portion of the container body extending between them; a cap detachable from the container body, having an open bottom portion of the cap, an open top portion of the cap, and an annular side wall portion of the cap extending between them, which is detachably inserted into the open top portion of the container body; and a lid detachably attached above the open top portion of the cap, which is sized to press-fit the cap into the container body and restricts the cap from rotating relative to the container body when fully fitted to the container body.

Description

Technical Field

[0001] The present disclosure generally relates to collection containers for containing biological samples such as blood samples. More specifically, the present disclosure relates to a sample collection container configured to be connected to a finger-based capillary blood collection device and receive a blood sample therefrom, including functions for ensuring that the container is properly closed and sealed to avoid leakage and / or contamination of the blood sample.

Background Art

[0002] This application claims priority to U.S. Provisional Application No. 63 / 216,277, titled "Sample Container for Capillary Blood Collection," filed on Jun. 29, 2021, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Devices for obtaining and collecting biological samples such as blood samples are commonly used in the medical industry. One type of blood collection commonly performed in the medical field is capillary blood collection, which is often done to collect a blood sample for testing. For example, in certain diseases such as diabetes, it is necessary to regularly test a patient's blood to monitor the patient's blood sugar level and the like. Further, in test kits such as cholesterol test kits, a blood sample is often required for analysis. The blood collection procedure typically involves pricking a finger or other suitable body part to collect a blood sample. Usually, the amount of blood required for such tests is relatively small, and usually, a small puncture or incision supplies enough blood for these tests. Various types of lancet devices have been developed for puncturing a patient's skin to collect a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available not only to individual consumers but also to hospitals, clinics, and medical offices. These devices typically include a sharp component, such as a needle or blade, used to make a quick puncture or incision in the patient's skin to draw a small amount of blood. To simplify capillary blood collection, lancet devices have evolved into automated devices that puncture or cut the patient's skin when a trigger mechanism is activated. In some devices, the needle or blade remains in a standby position until triggered by the user. When activated, the needle or blade punctures or cuts the patient's skin, such as their finger. Often, a spring is incorporated into the device to provide the "automatic" force needed to puncture or cut the patient's skin.

[0005] One type of contact-actuated lancet device, characterized by the automatic ejection and retraction of a puncture or cutting element from and into the device, is described in Patent Document 1 below, owned by Becton Dickinson & Company, the assignee of this application. The lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is located within the housing and is adapted to move between a retaining position or pre-actuated position in which the puncture element is held within the housing and a puncture position in which the puncture element extends through the front end of the housing. The lancet device includes a drive spring located within the housing that biases the lancet structure toward the puncture position and a retaining hub that holds the lancet structure in the retracted position against the biasing force of the drive spring. The retaining hub includes a pivot lever that engages tightly with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rear end of the housing, at least partially compressing the drive spring and disengaging the lever from tight engagement with the lancet structure. The received blood samples are collected and / or tested. This testing can be performed using a point-of-care (POC) testing device, or the samples can be collected and sent to a testing facility.

[0006] The use of lancet devices for capillary blood collection can be complex, requiring a high level of skill from the healthcare professional performing the procedure. The multi-step nature of the capillary blood collection process can introduce several variability factors that can lead to sample quality issues such as hemolysis, improper sample stabilization, and microcoagulation. The use of lancet devices to collect blood samples can introduce several variability factors that affect the collection of capillary blood samples, including, but are not limited to, keeping the lancet still during the procedure, obtaining sufficient blood flow from the puncture site, properly collecting the blood, and preventing coagulation. The most common causes of process variability are: (1) improper cleaning of the puncture site and removal of the first drop, which may contaminate the sample; (2) inconsistent puncture location and depth, which may result in insufficient sample volume and a high proportion of interstitial fluid; (3) inconsistent compression techniques and excessive pressure near the puncture site, which may facilitate blood collection (e.g., blood squeezing), which may cause hemolysis of the sample; (4) variable transfer interfaces and collection techniques, which may cause hemolysis or contamination of the sample; and (5) insufficient mixing of the sample and anticoagulant, which may result in microcoagulation.

[0007] Given the common causes of such process variations and the resulting sample quality issues, there is a need for blood collection devices and associated containers that can safely receive and store biological samples in sealed containers while minimizing the risk of leakage or contamination. In particular, the collection container of this disclosure is configured to receive a fluid sample from a blood collection device and hold the received fluid sample in a tightly sealed container until it is ready for use. Furthermore, the container of this disclosure is configured for ease of use, meaning that during use, the user does not need to apply significant force to the container or blood collection device, and it is easy to close the container or otherwise operate it. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 9380975 [Patent Document 2] U.S. Patent Application Publication No. 2019 / 0216380 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0223772 Specification [Patent Document 4] International Publication No. 2020 / 167746 [Overview of the project] [Problems that the invention aims to solve]

[0009] According to one aspect of the present disclosure, a sample collection container configured to be detachably attached 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 with an open top and a lower portion with a closed bottom. The lid includes a lid body, a flexible connection between the lid body and the upper part of the container body that moves the lid between a closed position in which the lid covers the open top of the upper portion and an open position in which the open top of the upper portion is not covered, a puncturable partition attached to the lid body that seals the top of the open top when the lid is in the closed position, and a latch. The latch extends from the lid body and engages with a catch on the upper part of the container body to secure the lid in the closed position. [Means for solving the problem]

[0010] According to another aspect of the present disclosure, a blood collection container includes a container body having a closed bottom portion, an open top portion, and an annular side wall portion of the container body extending between them. The container further includes a cap detachable from the container body. The cap includes an open bottom portion of the cap, an open top portion of the cap, and an annular side wall portion of the cap extending between them, which are removably inserted onto the open top portion of the container body. The container further includes a lid removably attached to the open top portion of the cap. The cap is made to be press-fitted onto the container body, and when fully fitted onto the container body, the cap is restricted from rotating relative to the container body.

[0011] According to another aspect of the present disclosure, a blood collection assembly includes a finger holder having a finger receiving portion and an actuation portion, a container engagement portion connected to the holder, and a collection container detachably connected to the container engagement portion. The container includes a container body defining an interior configured to receive a sample provided from a blood collection device, and a lid. The container body includes an upper portion including an opening top and a lower portion including a closed bottom. The lid includes a lid body, a flexible connection portion between the lid body and the upper part of the container body that moves the lid between a closed position in which the lid covers the opening top of the upper portion and an open position in which the opening top of the upper portion is not covered, a puncturable partition attached to the lid body that seals the opening of the upper portion when the lid is in the closed position, and a latch portion extending from the lid body that engages with a catch portion on the upper part of the container body to secure the lid in the closed position.

[0012] According to another aspect of the present disclosure, a cap removal assembly for removing the cap of a blood collection container from the container body of the blood collection container includes a stand configured to support the blood collection container in an upright position and to restrict the rotation of the container relative to the stand and a tool. The tool includes a cap remover and a handle extending therefrom. The cap remover includes a body defining an opening or recess sized to receive the cap of the blood collection container and at least one projection extending from the body into the opening or recess, positioned to engage with a portion of the cap so 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 are described in the following numbered sections.

[0014] Item 1: A sample collection container configured to be detachably attached 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; a container body comprising an upper portion having an open top and a lower portion having a closed bottom, the lid comprising: a lid body; a flexible connection between the lid body and the upper part of the container body for moving the lid between a closed position in which the lid covers the open top of the upper portion and an open position in which the open top of the upper portion is not covered; a puncturable partition attached to the lid body for sealing the opening of the upper portion when the lid is in the closed position; and a latch extending from the lid body for engaging with an upper catch portion on the upper part of the container body for securing the lid in the closed position.

[0015] Item 2: The collection container according to Item 1, wherein the latch comprises a frame portion formed of a first material and a cushion portion formed of a second material having lower rigidity than the first material, the cushion portion being positioned close to the leading edge of the frame portion of the lid and configured to restrict the latch from disengaging from the catch portion.

[0016] Item 3: The collection container according to Item 2, wherein the frame portion has an opening for receiving the upper catch portion when the lid is in the closed position, and the cushion portion is positioned on the frame portion between the opening and the front edge of the frame portion.

[0017] Item 4: The collection container according to item 2 or 3, wherein the lid body, flexible connector, and container body are made of the first material, and the partition is made of the second material.

[0018] Item 5: A collection container as described in any one of items 2-4, 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), urethane rubber, and latex rubber.

[0019] Item 6: The catch portion at the upper part of the container body has an inclined surface arranged to deflect over the catch portion before the latch portion engages with the catch portion when the lid moves between the open position and the closed position. The collection container according to any one of Items 1 to 5.

[0020] Item 7: The partition wall has an inward-facing surface facing the inside of the container body and an outward-facing surface facing the opposite side of the inward-facing surface. The outward-facing surface has a recess or depression arranged to collect any fluid leaking from the inside of the container body while retracting the needle through the partition wall. The collection container according to any one of Items 1 to 6.

[0021] Item 8: The lid body has an annular flange defining an opening, and the partition wall is inserted through the opening in a state where the annular flange is received within the annular notch portion of the partition wall. The collection container according to any one of Items 1 to 7.

[0022] Item 9: The partition wall has an inward-facing surface facing the inside of the container body when the lid is in the closed position, and the inward-facing surface of the partition wall has a chamfered peripheral edge. The collection container according to any one of Items 1 to 8.

[0023] Item 10: The inward-facing surface of the partition wall defines a central cavity that promotes radial deformation of the partition wall during centrifugation. The collection container according to Item 9.

[0024] Item 11: The central cavity has a tapered annular surface. The collection container according to Item 10.

[0025] Item 12: The upper opening top part has an annular chamfered edge arranged to contact the chamfered peripheral edge of the partition wall when the lid moves to the closed position. The collection container according to any one of Items 1 to 11.

[0026] Item 13: When the lid is in the closed position, the upper annular chamfered edge deforms the partition wall, thereby sealing the inside of the container body. The collection container according to Item 12.

[0027] Item 14: The collection container as described in Item 13, wherein the partition is configured to expand radially during centrifugal separation, thereby facilitating the sealing of the inside of the container body.

[0028] Item 15: A collection container as described in any one of items 1 through 14, wherein the lower part of the container body and the upper part of the container body are separable and can be attached to each other detachably.

[0029] Item 16: The collection container as described in Item 15, wherein the upper part is sized to press-fit into the lower part, and when fully fitted into the lower part, the upper part is restricted from rotating relative to the lower part.

[0030] Item 17: A collection container according to any one of items 1 to 16, wherein the lower part of the container body comprises a closed bottom portion, an open top portion of the lower part, and an annular side wall portion of the lower part extending between them, and the upper part of the container body comprises an open bottom portion of the upper part inserted on top of the open top portion of the lower part of the container body, an open top portion of the upper part, and an annular side wall portion of the upper part extending between them.

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

[0032] Item 19: The collection container according to Item 18, wherein the annular flange portion extending from the lower portion and the opening bottom of the upper portion have corresponding inclined surfaces configured to align axially when the upper portion is inserted onto the lower portion.

[0033] Item 20: The collection container as described in Item 19, wherein the rotation of the upper part relative to the lower part causes the inclined surface of the upper part to slide along the inclined surface of the annular flange of the lower part, thereby lifting the upper part away from the lower part.

[0034] Item 21: A collection container according to any one of items 17 to 20, wherein the lower portion comprises an annular projection extending radially outward from the outer surface of the side wall of the lower portion, and the inner surface of the side wall of the upper portion comprises an annular recess for receiving the annular projection of the lower portion.

[0035] Clause 22: The collection container according to Clause 21, wherein the annular projection extending from the lower portion comprises an inclined upper surface, a substantially flat lower surface, and a cylindrical periphery extending between them.

[0036] Item 23: A collection container according to any one of items 17 to 22, wherein the inner surface of the side wall of the lower part has a tapered portion that tapers radially inward from the top of the opening of the lower part.

[0037] Item 24: The collection container described in Item 23, wherein a tapered interlocking portion exists between the outer surface of the lower side wall and the inner surface of the upper side wall.

[0038] Clause 25: A flexible connector comprising a hinge, as described in any one of items 1 to 24.

[0039] Item 26: The blood collection container comprises a container body having a closed bottom, an open top, and an annular side wall extending between them; a cap detachable from the container body having an open bottom, an open top, and an annular side wall extending between them, which is detachably inserted into the open top of the container body; and a lid detachably attached to the open top of the cap, wherein the cap is sized to press-fit into the container body, and when fully fitted into the container body, the cap's rotation relative to the container body is restricted.

[0040] Item 27: A blood collection assembly comprising a finger holder having a finger receiving portion and an actuation portion; a container engagement portion connected to the holder; a collection container detachably connected to the container engagement portion; a container having a container body defining an interior configured to receive a sample provided from a blood collection device; a container body having an upper portion having an open top and a lower portion having a closed bottom; a lid comprising a lid body; a flexible connection portion between the lid body and the upper portion of the container body for moving the lid between a closed position covering the open top of the upper portion and an open position where the open top of the upper portion is not covered; a puncturable partition attached to the lid body for sealing the open top of the upper portion when the lid is in the closed position; and a latch portion extending from the lid body for engaging with a catch portion of the upper portion of the container body for fixing the lid in the closed position.

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

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

[0043] Item 30: A cap removal assembly as described in Item 28 or 29, comprising a ring defining an opening, wherein the cap can be inserted through the opening when the tool is in either an upward or downward orientation.

[0044] Item 31: The cap removal assembly described in Item 30, which allows for right-handed operation when the tool is facing upwards and left-handed operation when the tool is facing downwards.

[0045] Item 32: A cap removal assembly according to any one of items 28-31, the tool further comprising a pressing member attached to the handle and having a distal end extending beyond the opening of the removal portion, the pressing member being positioned to press the top of the cap in the opposite direction when the cap is inserted through the opening, thereby preventing the container from lifting off the stand when the tool and cap rotate relative to the container body.

[0046] Item 33: A cap remover comprising two projections extending into an opening or recess, as described in any one of items 28-32.

[0047] Item 34: The cap removal assembly according to Item 33, wherein the two protrusions are arranged such that a virtual line passing between the two protrusions through the center of the opening or recess is inclined with respect to the longitudinal axis of the handle portion.

[0048] Item 35: The incline is approximately 5 degrees to approximately 25 degrees, preferably approximately 15 degrees, for the cap removal assembly as described in Item 34. [Brief explanation of the drawing]

[0049] [Figure 1A] This is a perspective view of a capillary blood collection device and collection container for collecting a blood sample from a patient's finger, according to one aspect of the present disclosure. [Figure 1B] This is a cross-sectional view of a capillary blood collection device and a lancet according to one aspect of the present disclosure. [Figure 1C] This is a perspective view of a holder for a capillary blood collection device according to one aspect of the present disclosure. [Figure 1D] This is a schematic diagram showing a top view of the holder shown in Figure 1C, which is connected to the patient's finger to perform the blood collection procedure. [Figure 1E] This is another schematic diagram showing a front view of the holder in Figure 1C that is connected to the patient's finger. [Figure 2A] This is a perspective view of the upper portion of a sample collection container with an open lid, according to one aspect of the present disclosure. [Figure 2B] This is a perspective view of the upper part of the sample collection container shown in Figure 2A, which has a lid in the closed position. [Figure 2C] This is a cross-sectional view of the upper portion of the sample collection container of Figure 2A, which has a lid in the closed position, according to one aspect of the present disclosure. [Figure 3A] This invention presents the results of a finite element analysis modeling that shows the sealing force of the partition wall of the blood collection device under high-pressure fluid after assembly. [Figure 3B] This invention presents the results of a finite element analysis modeling that shows the sealing force of the partition wall of the blood collection device under high-pressure fluid after assembly. [Figure 4A] This is a perspective view of a sample collection container having an upper part or cap attached to a lower part, according to one aspect of the present disclosure. [Figure 4B] Figure 4A is a perspective view of the sample collection container with an upper part or cap separated from the lower part of the sample collection container. [Figure 4C] Figure 4A is a cross-sectional view of the sample collection container, which has an upper part or cap attached to the lower part of the container. [Figure 4D] Figure 4C is an enlarged cross-sectional view of a portion of the sample collection container according to one aspect of the present disclosure, showing the upper part of the container body or the interface between the cap and the lower part. [Figure 5A] This is a perspective view of a cap removal assembly and a sample collection container according to an aspect of the present disclosure. [Figure 5B] Figure 5A is a cross-sectional view of the cap removal assembly. [Figure 5C] This is a perspective view of the tool for the cap removal assembly shown in Figure 5A, according to one aspect of the present disclosure. [Figure 5D]Figure 5C is a top view of the tool, illustrating the positioning of the protruding portion of the cap remover according to one aspect of the present disclosure. [Figure 5E] This is a schematic diagram showing the use of a tool to remove the upper part or cap of the sample collection container from the lower part of the container. [Modes for carrying out the invention]

[0050] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any such modifications, variations, equivalents, and substitutes shall be considered to be within the spirit and scope of the invention.

[0051] For the purposes of the following description, “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “side,” “vertical,” and their derivatives are as they appear in the drawings and are relevant to the present invention. However, it should be understood that the present invention may envision alternative modifications and step sequences unless expressly otherwise specified. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0052] This disclosure relates to a blood collection device 10 or assembly 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 a lid of the container 16, which may include, for example, a cap and an integrated lid. The cap and integrated lid are configured to provide a tight enough closure to maintain a proper seal of the container 16 during and after centrifugation. The container 16 can be made from a rigid or semi-rigid material such as polypropylene. The integrated lid can be made from a mixture of a rigid or semi-rigid material and a flexible material such as a thermoplastic elastomer. The material and geometric shape of the lid are selected to allow one-handed closure and initial sealing of the container 16, meaning that the lid can be easily closed with little force required. The closure should also provide a high sealing pressure during centrifugation to prevent leakage. In some examples, the centrifugation process can be an inverse centrifugation process in which the container 16 is inserted into the centrifuge in an inverted orientation (i.e., with the lid of the container 16 positioned at the bottom of the container receiving cavity or well of the centrifuge). Thus, the lid can be designed to withstand the forces applied to it during inverse centrifugation. In some examples, a latch is provided to secure the lid in the closed position and to ensure an appropriate insertion depth for the flexible partition or sealing element of the lid.

[0053] This disclosure also relates to a two-part sample collection container 16 formed from a lower portion or container body and an upper portion or cap. The two portions are separable and can be joined together at a joint interface. The joint interface between the portions of the container body can be configured to allow for easy assembly of the container body while providing a secure airtight seal between the portions of the container body. For example, as will be described in more detail herein, the upper and / or lower portions of the container body may include an inclined surface or cam surface positioned such that rotation of the upper portion relative to the lower portion separates the upper portion or cap from the lower portion of the body.

[0054] Examples of blood collection devices 10 or assemblies incorporating the features of this disclosure are shown in Figures 1A–1E. For example, the blood collection device 10 can be a self-contained, fully integrated finger-based capillary blood collection device capable of lancening, collecting, and stabilizing large capillary blood samples, for example, up to 500 microliters or more, in a sample collection container 16. The blood collection device 10 or assembly can also be formed from separable components (i.e., a finger cuff, lance, and reservoir) that can be connected and / or used together to obtain a blood sample. Other exemplary capillary blood collection devices and assemblies that can be modified to incorporate the features of this disclosure are described, for example, in the above-mentioned Patent Document 2, titled “Apparatus for Obtaining Blood Samples,” the above-mentioned Patent Document 3, titled “Apparatus for Flow of Adhered Blood,” and the above-mentioned Patent Document 4, titled “Capillary Collector with Rotatable Connection,” each of which is incorporated herein by reference in its entirety.

[0055] Referring to Figures 1A and 1B, an exemplary blood collection device 10 includes an integrated holder 12, a lancet housing or lancet 14 (shown in Figure 1B) for puncturing the patient's finger 19 (shown in Figures 1D and 1E), and a sample collection container 16 (shown in Figures 1A and 2A-3D). In other examples, the blood collection device 10 can be provided as a semi-integrated device 10, which includes, for example, an integrated lancet housing 14 and a collection container 16 that can be connected to a separate holder 12. In other examples, the semi-integrated device 10 may have an inline flow and an integrated lancet housing 14 and a collection container 16 that can be connected to a separate holder 12.

[0056] The holder 12 is configured to receive a sample source for supplying a biological sample, such as a blood sample, for example, a patient's finger 19. As shown in Figures 1C-1E, the holder 12 generally includes a finger receiving section 20 having a first opening 22, an operating section 24, a port 26 having a second opening 28, and a fingertip guard 30. In some examples, the fingertip guard 30 provides a stopping section for properly positioning and securing the finger 19 within the holder 12. The fingertip guard 30 further helps ensure that the patient's finger 19 is positioned correctly within the finger receiving section 20 so that pressure applied to the patient's finger 19 results in adequate blood flow. The fingertip guard 30 may have a curved fingertip rest that ensures the patient's finger 19 stops at the end of the finger receiving section 20 and allows the patient's fingernail to pass through the end of the finger receiving section 20. The finger receiving section 20 allows the use of the holder 12 with artificial and natural fingernail styles present in the patient population.

[0057] The first opening 22 of the finger receiving section 20 is configured to receive a sample source, for example, a finger 19. The sample source may also include other parts of the body that can fit into the first opening 22, such as toes or other limbs. The port 26 communicates with the finger receiving section 20. For example, when a finger 19 is received in the holder 12, the port 26 communicates with a portion of the finger 19. The second opening 28 of the port 26 is configured to receive a lancet housing or lancet 14 (shown in Figure 1B) and a collection container 16 (shown in Figures 1A and 2A-3D). In some examples, the port 26 further includes a locking portion 32 for securely receiving the lancet housing or lancet 14 and the collection container 16 into the port 26.

[0058] The actuation part 24 of the device 10 has a second diameter smaller than the first diameter and is movable between a first position in which the holder 12 defines the first diameter and a second position in which the holder 12 defines the second diameter. Furthermore, in the first position, the holder 12 defines a first ellipse shape. In the second position, the holder 12 has a first ellipse shape different from the second ellipse shape and defines the second ellipse shape. Thus, when the holder 12 is in the second position with the smaller diameter, a portion of the holder 12 comes into contact with the sample source (i.e., the finger 19), as will be described in more detail below, and the actuation part 24 of the holder 12 can pump and / or extract blood.

[0059] In some examples, the actuation unit 24 includes a contact member 34. When the actuation unit 24 is in a first position, the contact member 34 is positioned in a first position relative to the sample source such that the contact member 34 is in a disengaged position, i.e., the contact member 34 can make slight contact with the sample source. When the actuation unit 24 is in a second position, the contact member 34 is positioned in a second position relative to the finger 19 such that the contact member 34 is in an engaged position, i.e., the contact member 34 makes pressurized contact with the finger 19, and the actuation unit 24 of the holder 12 can pump and / or extract blood. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0060] In some examples, the actuation mechanism 24 includes a pumping member 36 for applying pressure to the finger 19, such as a pair of opposing tabs or wings 38. Each wing 38 may include a contact member 34. The holder 12 may also include a living hinge portion 42. The living hinge portion 42 allows the user to squeeze the wings 38 between a first position (passive state) and a second position (active state). The use of the tabs or wings 38 to draw blood from the patient's finger 19 is considered to minimize hemolysis while maintaining adequate blood flow from the patient's finger 19. The resting position and hinge of the wings 38 are designed to bend to accommodate the largest patient's finger within the holder 12 without causing blood occlusion, while maintaining contact and retention with the smallest patient's finger that can fit into the holder 12. In some examples, the wings 38 may be positioned above the finger receiving portion 20, proximal to the patient's nail and distal to the patient's first joint, to avoid hard tissue on the patient's finger 19.

[0061] The holder 12 can be configured to allow the user to repeatedly squeeze and release the wings 38 to draw and / or extract blood from the finger 19 until a desired amount of blood fills the collection container 16. The wings 38 are configured to maintain gentle contact with a range of patient finger sizes that can be used with the holder 12 and to flex in order to hold the holder 12 on the patient's finger 19. The wings 38 may also provide an active pressure function to the holder 12.

[0062] In some examples, the holder 12 may include a stabilizing extension 40, which provides additional support to ensure the holder 12 is securely positioned on the finger 19. In one example, the finger receiving portion 20 forms a substantially C-shaped member and includes multiple inner gripping members to provide additional grip and support to the holder 12, which is securely positioned on the patient's finger 19. The stabilizing extension 40 helps maintain contact with the patient's finger 19 during use of the holder 12, while avoiding the blood supply and knuckles of the patient's finger 19.

[0063] The blood collection device 10 for collecting a blood sample also includes a lancet housing or lancet 14 (shown in Figure 1B) that is detachably connected to a port 26 of the holder 12. Referring to Figure 1B, the lancet housing or lancet 14 may include an entrance or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a storage mechanism 58, and a drive spring 60. The puncture element 54 may be movable between a pre-operation position in which the puncture element 54 is held within the interior 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the entrance 50 of the lancet housing or lancet 14 to puncture a portion of the finger 19. In one example, the lancet 14 of this disclosure is a contact-actuated lancet and may be configured according to the features disclosed in the above-mentioned Patent Document 1 entitled "Contact-Actuated Lancet Device," the whole thereof is incorporated herein by reference.

[0064] In some examples, the holder 12 and the lancet housing or lancet 14 are separate components that may be detachably connected to the port 26 of the holder 12. In such examples, the lancet housing or lancet 14 includes an engagement portion 56. The lancet housing or lancet 14 may be pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing or lancet 14 locks into the locking portion 32 of the holder 12. In this way, the lancet housing 14 can be securely connected and locked to the holder 12 so that the puncture element 54 of the lancet housing 14 is activated to prick or puncture a sample source, for example, a finger 19. In some examples, the port 26 of the holder 12 includes a number of ribs for securing and locking the lancet 14 or collection container 16 into the port 26.

[0065] To activate the lancet 14, the lancet 14 is pressed against the finger 19 to activate the lancet 14's retraction mechanism 58 and drive spring 60 in order to pierce the finger 19. After puncture, the puncture element 54 is immediately retracted and securely fixed inside the lancet housing 14 52. 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, such as an anticoagulant, to stabilize the blood sample and / or components of the blood sample placed therein. The collection container 16 may include at least one filling line corresponding to a predetermined volume of sample. The collection container 16 may display / measure the volume of blood collected.

[0066] To use the capillary blood collection device 10 shown in Figures 1A to 1E, first, the desired finger 19 is cleaned, a holder 12 of the appropriate size for the desired finger 19 is selected, and the finger 19 is securely positioned. Next, the lancet housing or lancet 14 is connected to the port 26 of the holder 12. As previously mentioned, the lancet housing or lancet 14 is pushed into the port 26 of the holder 12 so that the engaging portion 56 of the lancet housing or lancet 14 is locked into the locking portion 32 of the holder 12. In this way, the lancet housing or lancet 14 is securely connected and locked to the holder 12 so that the puncture element 54 of the lancet housing 14 can be activated to prick or puncture the finger 19. Once the lancet 14 is connected to the port 26 of the holder 12, the lancet 14 communicates with the finger 19.

[0067] When the user wants to activate the lancet 14 to prick the skin of the finger 19, the lancet 14 is pressed against the finger 19 to activate the retraction mechanism 58 of the lancet 14 in order to prick the finger 19. After the finger 19 has been pricked to produce blood flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. With the container 16 properly secured in the holder 12 for collecting a blood sample, the user repeatedly squeezes and releases the wings 38 of the holder 12 to draw and / or extract blood from the finger 19 until the desired amount of blood is collected in the collection container 16. Advantageously, when the holder 12 is positioned over the finger 19, the holder 12 does not restrict blood flow and defines the lance and finger constriction position. The constriction tab or wings 38 provide a predetermined range of constriction pressure that is consistently applied across the entire finger 19. By doing so, the holder 12 provides a gently controlled massage of the finger 19 that stimulates blood extraction and minimizes potential hemolysis.

[0068] Once the desired amount of blood has been collected in the container 16, the blood collection portion, including the collection container 16, may be removed from the collection device 10 to send the collected sample to a diagnostic instrument and / or testing device. After being removed from the collection device 10, the blood collection portion may be sealed via a cap or partition to protectively seal the blood sample inside the collection container 16.

[0069] Lid and latch of sample collection container

[0070] The features of the cap and lid of the collection container 16 are shown in Figures 2A-2C. As previously mentioned, the interface between the cap and lid is configured to be easily closed (i.e., one-handed operation) while providing a strong enough seal to prevent the sample from leaking out of the container 16 between the cap and lid, for example, during reverse centrifugation.

[0071] As shown in Figures 2A to 2C, the blood collection container 16 of the present 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 having an open or partially open top 116 and a lower portion 118 (also referred to herein as a base or body) having a closed bottom 120 (shown in Figures 4A to 4C). In some examples, the upper portion 114 and the lower portion 118 are integrally formed and / or are irremovably attached, for example, by adhesive or ultrasonic welding.

[0072] In other examples, as most clearly shown in Figures 4A–4D, the upper portion 114 or cap and the lower portion 118 are separate components that can be removably connected to each other and can be disassembled, for example, by twisting the upper portion 114 or cap against the lower portion 118 and / or by pulling the upper portion 114 or cap axially away from the lower portion 118. In some examples, the lower portion 118 of the container body 110 may include a closed bottom 120, an open top portion 122 of the lower portion, and an annular side wall portion 124 of the lower portion extending between them. Similarly, the upper portion 114 or cap may include an open bottom 126 inserted over the open top portion 122 of the lower portion 118, an open top portion 116 of the upper portion, and an annular side wall portion 128 of the upper portion extending between them.

[0073] The sample collection container 16 further includes a lid 130 comprising a lid body 132, a flexible connector such as a hinge 134 or living hinge, a puncturable partition 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 that opens and closes, thereby moving the lid 130 between a closed position (e.g., shown in Figure 2B) where the lid 130 covers the top apex 116 of the top portion 114 or cap, and an open position (e.g., shown in Figure 2A) where the top apex 116 of the top portion 114 or cap is not covered. Various structures of the flexible connector or hinge 134, which can be formed from rigid or semi-rigid materials, are known to those skilled in the art and can be adapted for use in the collection container 16 of this disclosure. For example, the hinge 134 can be an elongated member that includes one or more notches or cut lines that provide a bending point to the hinge 134. The hinge 134 is configured to pivot or unfold around the bending point, thereby allowing the lid 130 to move between a closed position and an open position.

[0074] As most clearly shown in Figure 2C, the punctureable partition 136 is attached to the lid body 132 and seals the opening top 116 of the upper portion 114 when the lid 130 is in the closed position. The latch portion 138 extends from the lid body 132 and engages with a projection or catch portion 140 on the upper portion 114 of the container body 110 or on the cap to secure the lid 130 in the closed position when the lid 130 is in the closed position.

[0075] One advantage of the latch portion 138 is that it helps align the upper portion 114 or the opening top 116 of the cap with the partition 136, even when the user attempts to close the lid 130 with one hand. Thus, the latch portion 138 advantageously avoids errors caused by improper alignment of the lid 130 and the container body 110. The latch portion 138, partition 136, and flexible connector or hinge 134 of the lid 130 of this disclosure also contribute to creating a secure engagement between the lid 130 and the container body 110. The inventors 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 expected or anticipated misuse of the container 16, and therefore easy closure and secure engagement are necessary. The lid 130 and latch portion 138 of this disclosure are configured to overcome such loads, so that the lid 130 remains in the closed position to protect the blood sample contained within the container 16. For example, force may be applied to the lid 130 and / or latch 138 during automated handling, causing the collection container 16 to be dropped into the centrifuge recess for a distance of approximately 4 to 18 inches (upside down or with the lid 130 facing downwards). The collection container 16 may also be subjected to force during load, torque, and / or impact during automated handling by the blood analyzer. The collection container 16 may also be subjected to accidental drops by the user, who may drop the collection container 16 for a vertical distance much longer than 18 inches. Force 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. Force may also be applied to the lid 130 and / or latch 138 when, for example, the aspiration needle is withdrawn through the puncturable partition 136, potentially pulling the lid 130 away from the upper portion 114 of the container body 110 or the cap. Furthermore, the latch 138 also functions as an anti-tampering system to prevent the collection container 16 from being accidentally opened or blood from spilling out.

[0076] Referring again to Figures 2A to 2C, in some examples, the latch portion 138 includes a frame portion 142 that defines an opening 144 for receiving the catch portion 140 of the upper portion 114 or cap when the lid 130 is in the closed position. For example, the opening 144 can be a square or rectangular opening 144 sized to receive a similarly sized square or rectangular projection extending radially outward from the outer surface of the side wall portion 128 of the upper portion 114 or cap. In some examples, the catch portion 140 includes an inclined surface or slope 146 arranged so that when the lid 130 moves between the open and closed positions, the latch portion 138 is assisted by the inclined surface 146 to deflect over the catch portion 140, and then snaps back into place to engage with the catch portion 140. The frame portion 142 of the latch portion 138, together with the lid body 132 and the hinge 134, can be integrally formed by injection molding from a hard or semi-hard material such as hard plastic (i.e., polypropylene).

[0077] The latch portion 138 also includes a cushion portion 148 or spacer positioned on or near the leading edge portion 150 of the frame portion 142 of the lid 130. The cushion portion 148 is provided to restrict the latch portion 138 from easily and / or unintentionally disengaging from the catch portion 140. As used herein, a restricting structure such as a cushion portion “restricts” another structure (i.e., the latch portion 138) from disengaging when additional force, time, or the performance of a more complex action is required to cause release, compared to the absence of the restricting structure. In particular, as relating to this disclosure, it is understood that the cushion portion 148 does not completely prevent the latch portion 138 from disengaging from the catch portion 140. Rather, as will be further described herein, the cushion portion 148 makes it more difficult for the user to disengage the latch portion 138 from the catch portion 140 than in the absence of the cushion portion 148, which means that the likelihood of accidental release of the latch portion 138 is lower.

[0078] The cushion portion 148 may be formed from a flexible material (i.e., a material more flexible than the material used to form the frame portion 142, the flexible connector or hinge 134, and / or the container body 110). For example, the cushion portion 148 can be formed from a thermoplastic elastomer. The partition wall 136 may also be formed from a thermoplastic elastomer such as liquid silicone rubber (LSR), urethane rubber, or latex rubber. In other examples, the cushion portion 148 and / or the partition wall 136 can be formed from other flexible elastomer materials such as silicone.

[0079] When moving the lid 130 to the closed position, the rigidity of the frame portion 142 acts to secure the latch portion 138 to the catch portion 140. In particular, the latch portion 138 can be configured to function as a cantilever, which means that the latch portion 138 bends on the catch portion 140 and then snaps into place, thereby forming a secure engagement between the latch portion 138 and the catch portion 140. The cushion portion 148 functions as an anti-tampering mechanism. In particular, the cushion portion 148 on the leading edge portion 150 of the latch portion 138 makes it more difficult for a user (i.e., the user's finger or any unintended removal tool) to obtain sufficient leverage to pry off the latch portion 138 by blocking the space into which a user's fingernail or tool could be inserted to pry open the latch portion 138. Advantageously, when the cushion portion 148 is present, it is virtually impossible for a user, gloved, to insert their hand under the latch portion 138 and obtain sufficient leverage to release it, making accidental opening in a medical setting highly unlikely. To release the latch portion 138, a dedicated removal tool may be provided, sized to be inserted under the cushion portion 148 to release the latch portion 138. By providing a lid 130 and latch portion 138 that can only be easily opened using a specific and specially designed removal tool, it is ensured that the lid 130 is opened only in a controlled and purposeful manner.

[0080] Another advantage of the cushion portion 148 is that it increases the flexibility of the latch portion 138 compared to the case where the cushion portion 148 is absent. Specifically, because the cushion portion 148 is present on the latch portion 138, the frame portion 142 of the latch portion 138 can be made considerably thinner without the risk of breakage. The combination of the thin frame portion 142 and the flexible cushion portion 148 means that the latch portion 138 can be easily bent in the rearward direction (i.e., radially away from the container body 110). This inherent flexibility of the latch portion 138 allows the latch portion 138 to easily deflect over the catch portion 140 with the help of the inclined surface or slope 146 of the catch portion 140 while closing, and then snap back into position to engage with the catch portion 140. Thus, the cushion portion 148 also contributes to the easy one-handed closing provided by the lid 130 and latch portion 138 of this disclosure.

[0081] In some examples, the lid body 132 may include an annular flange portion 152 defining the opening 154. As shown in Figure 2C, the partition 136 is inserted through the opening 154 with the annular flange portion 152 received within the annular notch portion 156 of the partition 136. The partition 136 is configured to press-fit into the opening top 116 or cap of the upper portion 114 of the container body 110, thereby sealing the blood collection container 16 when the lid 130 is in the closed position. As previously stated, the engagement between the partition 136 and the opening top 116 of the upper portion 114 is intended to provide a seal strong enough to withstand the forces applied to the partition 136 and / or the sample collection container 16 during reverse centrifugation. To create a robust seal, the inner diameter of the opening top 116 of the upper portion 114 and the outer diameter of the partition 136 are selected to control the initial closing force required to close the lid 130 and the initial sealing pressure provided by the partition 136. The geometric shape and inherent flexibility of the partition wall 136 also contribute to the high-pressure sealing characteristics of the partition wall 136 during reverse centrifugal separation. In particular, the initial interference (i.e., outer diameter minus inner diameter) between the opening top 116 of the upper portion 114 and the partition wall 136 is optimized to allow both easy closing force and sufficient initial sealing pressure over the entire tolerance range.

[0082] In some examples, the partition wall 136 may include an inward-facing surface 158 facing the interior 112 of the container body 110 and an outward-facing surface 160 opposite the inward-facing surface 158. In some examples, the inward-facing surface 158 of the partition wall 136 includes a chamfered edge 162. As used herein, a “chamfered” edge refers to an edge that is inclined, angled, or tapered inward to facilitate the insertion of the partition wall 136 into the container body 110. In some examples, the chamfered edge 162 includes an annular inclined surface. In other examples, as shown in Figure 2C, the chamfered edge 162 is an annular curved surface. Similarly, the upper portion 114 or cap of the container body 110 may include an annular chamfered edge 164 positioned to contact the chamfered edge 162 of the partition wall 136 when the lid 130 moves to the closed position. The upper portion 114 or the annular chamfered edge 164 of the cap is sized and configured to deform the partition wall 136 when the lid 130 is in the closed position, thereby sealing the inside 112 of the container body 110.

[0083] The chamfered edges 162 and 164 also contribute to the low closing force of the interface between the lid 130 and the container body 110, allowing it to be closed with one hand without the need for tools. In particular, the chamfered edges 162 and 164 are shaped and positioned to slide easily toward each other, requiring minimal pressing force to close the lid 130. The latch portion 138 also contributes to ensuring that a proper seal is reliably formed by visually confirming that the partition 136 is inserted into the container body 110 to the appropriate insertion depth. In particular, the user can often see and hear when the opening 144 of the latch portion 138 snaps and / or engages with the catch portion 140.

[0084] When the partition wall 136 is inserted into the container body 110 to the appropriate sealing depth, the high pressure of reverse centrifugal separation is applied to the partition wall 136, which may undergo "mushrooming." Mushrooming refers to the deformation of the partition wall 136 in which a portion of the partition wall 136 moves radially outward to contact and press against the side wall portion 128 of the upper portion 114 in order to facilitate the seal between the partition wall 136 and the container body 110. In some cases, the geometric shape of the partition wall 136 also contributes to the mushrooming effect that occurs during centrifugal separation. For example, the inward surface 158 of the partition wall 136 may contain or define a central cavity 166 that facilitates the radial deformation of the partition wall 136 during centrifugal separation. The central cavity 166 may be of any shape that increases or improves the radial flexibility of the peripheral edge of the partition wall 136. For example, as shown in Figure 2C, the cavity 166 includes a tapered surface, such as a tapered annular surface that forms a conical or V-shaped cavity. The conical or V-shaped geometric shape of the cavity 166 of the partition wall 136 allows the flexible material of the partition wall 136 to bend outward and increase the sealing pressure when the partition wall 136 is subjected to the high gravity of inverse centrifugal separation. Specifically, because the container 16 is placed upside down in the centrifuge, or with the lid facing forward, the fluid contents inside the container body 110 112 push against the partition wall 136 due to gravity and the gravity generated during centrifugal separation. This force causes the peripheral portion of the partition wall 136 to bend radially outward against the rigid side wall portion 128 of the upper portion 114 of the container body 110 or the cap, thereby causing the partition wall 136 to take on a mushroom shape and promoting engagement between the partition wall 136 and the side wall portion 128. This mushrooming or bulging of the partition wall 136 increases the sealing pressure, preventing the sample from leaking out of the container 16. The radial expansion of the partition wall 136 is shown by the finite element analysis models in Figures 4A and 4B. As shown in Figures 3A and 3B, the sealing force of the partition wall 136 increases substantially as the fluid pressure applied to the inward surface 158 of the partition wall 136 increases. For example, as shown in Figure 3A, at low pressure (i.e., after assembly), the sealing force of the partition wall is approximately 48 psi.As shown in Figure 3B, when a fluid pressure of 120 psi is applied to the partition wall 136, the sealing force increases to 205 psi.

[0085] Continuing to refer to Figures 2A-2C, the outward-facing surface 160 of the partition wall 136 may include, for example, a recess or depression 168 positioned to collect any fluid leaking from the interior 112 of the container body 110 while the needle is retracted through the partition wall 136. More specifically, the recess or depression 168 may be a blood splatter depression. The depression 168 may be configured so that any residual blood leaking during the retraction of the aspiration needle is contained within the recessed blood splatter depression 168. Thus, since the residual blood does not exist as a surface that comes into direct contact, blood exposure in the laboratory environment is limited.

[0086] As is known in the art, seal structures formed from flexible materials such as thermoplastic elastomers can develop compression set when held under stress for extended periods. While this may be disadvantageous for long-term seals, the partition wall 136 of this disclosure is not generally expected to be under stress for most of its service life. Instead, the partition wall 136 is expected to be under stress only during a single use, particularly after the blood sample has been taken and the lid has been closed. Therefore, the total duration during which the partition wall 136 is under stress (including during the reverse centrifugation process) is expected to be approximately 48 hours. During this short period, the partition wall 136 is not expected to develop compression set and / or lose its sealing ability. Furthermore, the material and shape of the partition wall 136 of this disclosure allow the partition wall 136 to enhance the sealing performance of the container 16, particularly during reverse centrifugation, by utilizing the inherent flexibility of the material, such as a thermoplastic elastomer, without being plagued by problems associated with compression set over time, when used as a disposable product.

[0087] The flexible material (i.e., thermoplastic elastomer) of the partition wall 136 can be easily processed by injection molding. Advantageously, features of the partition wall 136, such as the recess 168, cavity 166, and notch 156, are formed without undercuts, enabling simple injection molding for manufacturing. Furthermore, the injection-molded material can form a bond with a semi-rigid substrate such as the lid body 132, thereby enabling the bonding of the lid body 132 and the partition wall 136. Such bonding of the partition wall 136 and the lid body 132 results in a robust and easy-to-produce component that allows for mass production with little or no assembly. Other materials may also be used to form the lid body 132 and / or the partition wall 136, but lids 130 formed from most other materials require assembly and / or bonding of rigid / flexible parts, which can result in a more expensive manufacturing process. For example, silicone materials provide excellent flexibility and exhibit less compression set behavior than the thermoplastic elastomer materials described herein. However, since silicone does not bond with the lid body 132 or frame portion 142 formed from polypropylene, it is more difficult to manufacture the silicone partition wall 136 by injection molding.

[0088] Another advantage of the sample collection container 16 of this disclosure is that the partition 136 is integrated with the lid 130. Similarly, the lid 130 and the latch 138 are integrated with the container body 112 via a hinge 134. This structure allows for a single-component configuration, which is considered advantageous compared to devices and assemblies formed from multiple separate components. In particular, loose components can be lost or dropped by the user and (in the case of O-rings) may require additional assembly steps during manufacturing. Also, O-rings would not allow for the increased sealing pressure during reverse centrifugation as provided by the partition 136 of this disclosure.

[0089] While a seal between the lid 130 and the container body 110 can also be achieved using two rigid materials (i.e., surface-to-surface contact between the opposing polypropylene structures of the lid 130 and the container body 110), such engagement between rigid materials would require a high closing force or a closing method such as a threaded or push-fit connection to give the user a mechanical advantage in pushing the lid 130 into the closed position. If a threaded portion is used, the lid 130 must be able to rotate freely relative to the container body. In that case, the lid 130 would need to be a separate component from the container body 110. The lid 130 could be attached to the container body 110 by, for example, a tether, but such a configuration 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, including an integrated lid 130, partition 136, and latch 138, offers advantages over other types of lids and covers known in the art.

[0090] A sample collection container with a separable body.

[0091] Referring to Figures 4A to 4D, the upper portion 114 or cap of the container body 110 may be attached detachably and / or removablely from the lower portion 118 of the container body 110. The connection interface between the upper portion 114 or cap and the lower portion 118 may be configured to provide an easy guided assembly (i.e., an 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), a secure liquid-tight and airtight seal between portions 114, 118, and controlled disassembly during cap removal using a dedicated cap removal tool.

[0092] As shown in Figures 4C and 4D, the upper portion 114 or cap is made to be press-fitted onto the lower portion 118 at an overlap distance D1. As used herein, “overlap distance” refers to the maximum distance that 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 seated on the lower portion 118. In this fully seated position (i.e., overlap distance D1), the upper portion 114 is restricted from rotation relative to the lower portion 118. As used herein, the first structure is “restricted” from rotation relative to the second structure when a component of the first structure and / or the second structure makes it more difficult for the structures to rotate relative to each other than if that component were not present. For example, the first structure and / or the second structure may include projections, recesses, locking mechanisms, inclined surfaces, threads, and any other components that make it more difficult for one structure to rotate relative to the other. While it is still possible for the user to rotate the first structure relative to the second structure, sufficient force is required to overcome the engagement between the first and second structures, provided, for example, by projections, recesses, retaining elements, inclined surfaces, threads, or other components.

[0093] The upper portion 114 or cap and the lower portion 118 of the container body 110 are intended to connect securely to each other to protect the blood sample inside the container body 110 112. Furthermore, the inventors believe that the connection or interface between portions 114, 118 must be sufficiently secure and robust to withstand foreseeable misuse without the upper portion 114 or cap leaking or separating from the lower portion 118 when improper or unexpected. At appropriate times, the connection or interface between the upper portion 114 or cap and the lower portion 118 should be easily overcome in a controlled manner, thereby allowing the user easy access to the blood sample contained inside the container body 110 112. As will be described in more detail below, this robust and secure connection is achieved by a tapered interlocking seal connection combined with a cam or ramp surface to provide a mechanical advantage when separating the upper portion 114 or cap from the lower portion 118. Beneficially, the connection or joining interface of the present disclosure is expected to be easy to assemble and includes components for controlling radial orientation. The upper part 114 or cap and the lower part 118 do not separate easily, which means that it is difficult for the user to inadvertently separate the upper part 114 or cap from the lower part 118 at an inappropriate time.

[0094] In some examples, as shown in Figures 4A to 4D, the lower portion 118 of the container body 110 includes an annular flange portion 170 extending radially outward from the outer surface 172 of the annular side wall portion 124 of the lower portion 118. The annular flange portion 170 can be configured such that when the upper portion 114 is inserted onto the lower portion 118, the open bottom 126 or cap of the upper portion 114 contacts the annular flange portion 170 of the lower portion 118 to restrict the rotation of the upper portion 114 relative to the lower portion 118. In some examples, the rotation of the upper portion 114 or cap relative to the lower portion 118 is restricted by the engagement between cams or inclined surfaces 174a, 174b (shown in Figures 4A to 4C) on the annular flange portion 170 and corresponding cams or inclined surfaces 176a, 176b (shown in Figures 4A to 4C) on the bottom 126 of the upper portion 114 or cap. The inclined surfaces 174a, 174b, 176a, and 176b are also configured to help control the radial orientation of the upper portion 114 or the cap relative to the lower portion 118 during assembly.

[0095] More specifically, in some examples, the annular flange portion 170 extending from the lower portion 118 includes a first inclined surface 174a inclined in a first direction and a second inclined surface 174b inclined in a second direction. The upper portion 114 or the bottom portion 126 of the cap includes corresponding inclined surfaces such as the first inclined surface 176a and the second inclined surface 176b, and is configured to axially align with the inclined surfaces 174a, 174b of the lower portion 118 when the upper portion 114 is inserted onto the lower portion 118. In some examples, the first inclined surface 174a and the second inclined surface 174b are adjacent to each other and form a crown or peak 178 toward the top portion 122 of the lower portion 118. The inclined surfaces 176a, 176b on the bottom portion 126 of the upper portion 114 also form a peak that aligns with the peak 178 of the annular flange portion 170. In some examples, the annular flange portion 170 and the upper portion 114 or the bottom portion 126 of the cap may include multiple vertices 178, such as two vertices located on the opposite side of the annular flange portion 170. In other examples, the annular flange portion 170 and the upper portion 114 or the bottom portion 126 of the cap may include two or more vertices, such as four vertices located at 0 degrees, 90 degrees, 180 degrees, and 270 degrees around the annular flange portion 170 and / or the bottom portion 126.

[0096] In some examples, the inclined surfaces 174a, 174b, 176a, 176b are positioned not only to restrict the rotation of portions 114, 118, but also to help separate the upper portion 114 of the container body 110 or the cap from the lower portion 118. For example, the inclined surfaces 174a, 174b, 176a, 176b can slide along the inclined surfaces 174a, 174b of the annular flange portion 170 of the lower portion 114, thereby causing a small amount of rotation (i.e., a quarter turn) relative to the upper portion 114 or the lower portion 118 of the cap to occur on the inclined surfaces 176a, 176b of the upper portion 114 in order to lift the upper portion 114 from the lower portion 118. Thus, the inclined surfaces 174a, 174b, 176a, 176b provide a mechanical advantage for controlling disassembly during cap removal. Specifically, with the lower portion 118 of the container body 110 fixed, the rotation of the upper portion 114 or the cap causes the inclined surfaces 174a and 174b to push the upper portion 114 or the cap axially away from the lower portion 118 beyond the axial holding features, thereby releasing the upper portion 114 from the lower portion 118. Once the upper portion 114 is moved beyond the axial holding mechanism, 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.

[0097] Therefore, it is understood that the upper portion 114 or cap is not completely free from the lower portion 118 after a small rotation (i.e., a quarter turn). Instead, the small rotation releases the upper portion 114 or cap from the lower portion 118, making it possible to easily separate it, for example, by a gloved user (i.e., with the force of gloved fingertips). Furthermore, with a relatively simple release technique, it is considered that the fluid contents (i.e., blood sample) in the container 16 will not be obstructed during this release operation by, for example, spasms or sudden movements that could cause spillage.

[0098] It is recognized that the upper portion 114 or cap can also be connected to the lower portion 118 by other connection interfaces known in the art, such as screw connections or Luer lock connections. However, while general screw connections join and seal the interface between the upper portion 114 or cap and the lower portion 118, general screw connections do not allow for control of the orientation of the upper portion 114 or cap relative to the lower portion 118. Furthermore, general screw connections are not as easy to install in high-speed assembly production environments compared to the axial press-fit connection of this disclosure. Moreover, general screw connections can be easily disengaged by the user at an inappropriate time 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 enables easy assembly in high-speed automated production and a robust connection that is not easily broken by the user.

[0099] In some examples, engagement between the upper portion 114 or cap of the container body 110 and the lower portion 118 can be further facilitated by projections, extensions, textured areas, and / or similar protruding structures extending from the surface of the side wall of the upper portion 114 or cap and / or from the side wall of the lower portion 118. For example, as shown in Figures 4C and 4D, the lower portion 118 of the container body 110 may include an annular projection 180 extending radially outward from the outer surface 172 of the annular side wall 124 of the lower portion 118. The inner surface 182 of the side wall 128 of the upper portion may include an annular recess 184 that receives the annular projection 180 of the lower portion 118. The annular projection 180 may be shaped to facilitate sliding the upper portion 114 or cap onto the lower portion 118. For example, the annular projection 180 of the lower portion 118 may include an inclined upper surface 186a, a substantially flat lower surface 186b, and a cylindrical peripheral portion 186c extending between them. The inner surface 182 of the upper portion 114 or cap is configured to slide along the inclined upper surface 186a of the annular projection 180, slightly pushing the side wall portion 128 of the upper portion 114 or cap radially outward to facilitate insertion of the lower portion 118 into the upper portion 114.

[0100] In some examples, the engagement between the upper portion 114 or cap and the lower portion 118 is further facilitated by providing a slight taper to the sidewall portion 124 of the lower portion near the apex 122 of the lower portion 118. For example, the sidewall portion 124 of the lower portion 118 may include a tapered portion 188 that tapers radially outward toward the opening apex 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 sidewall portion 124 of the lower portion and the inner surface 182 of the sidewall portion 128 of the upper portion. To provide a tapered interference fit, the tapered inner diameter of the upper portion 114 or cap and the tapered upper diameter of the lower portion 118 are selected to allow for a simple axial press-fit assembly. Furthermore, the geometric shape of the taper allows for axial alignment during assembly, enabling the two portions 114, 118 of the container body 110 to be guided together.

[0101] In some examples, the upper portion 114 or cap may include one or more reinforcing ribs 190 extending from the outer surface 194 of the side wall portion 128 of the upper portion 114. For example, the reinforcing ribs 190 may be annular ribs or areas with increased thickness that increase the overall rigidity of the upper portion 114. The increased rigidity of the upper portion 114 is thought to provide a more secure connection between portions 114 and 118. The axial length of the tapered portion 188 or seal area, and the annular flange portion 170 of the lower portion 118 also help to make the joint interface between portions 114 and 118 more rigid and prevent wobbling. At least these features are thought to strengthen the interface between portions 114 and 118 and help maintain the seal pressure over the entire storage period of the collection container 16, and also help to resist creep and material erosion over time. In contrast, while a simple annular bead / band on either of sections 114 or 118 would provide a seal, it would not offer a robust mechanical connection to withstand use / abuse, eliminate wobble, and maintain a liquid-tight / airtight seal. Furthermore, the annular bead / band would result in an undercut shape in the injection molding die, requiring tighter tolerances and / or complex tooling during manufacturing compared to providing a simple tapered interlocking fit.

[0102] Removal tool for separating the main body of the container

[0103] In some examples, the upper portion 114 or cap and / or lower portion 118 of the container body 110 include features that assist in the removal of the cap using a specially designed or selected tool. For example, the upper portion 114 or cap may include a U-shaped rib 192 (shown in Figures 4A-4C) that connects to a tool to provide a mechanical advantage during a small (i.e., quarter-turn) rotation to release the upper portion 114. The U-shaped rib 192 may be relatively shallow so that the user does not attempt to grasp the rib 192 by using their fingers instead of a tool to release the upper portion 114. However, the U-shaped rib 192 should be deep enough so that when a particular tool makes contact, the U-shaped rib 192 transmits sufficient torque from the tool to the upper portion 114 or cap in order to release the upper portion 114 or cap from the lower portion 118. Furthermore, preferably, the tool can be configured so that no stress is applied to the interface between the lid 130 and the top portion 116 of the upper portion 114 or cap in order to avoid damaging the seal between the partition wall 136 of the lid 130 and the top portion 116 of the upper portion 114 or cap during the operation to remove the cap.

[0104] A cap removal assembly 210, which includes features of the present disclosure for disassembling the upper portion 114 or cap of the blood collection container 16 from the container body 110 or lower portion 118, is shown in Figures 5A–5D. The assembly 210 includes features intended to make the operation of removing the cap very easy and effortless, and to prevent accidental removal of the cap during use (blood collection and handling).

[0105] The assembly 210 includes a stand 212 configured to support the blood collection container 16 in an upright position and to restrict the rotation of the container 16 relative to the stand 212. For example, the stand 212 can be a tubular structure including a closed bottom or base 214 and an open top 216. The open top 216 can be sized so as to ensure that the collection container 16 can be reliably inserted into the stand 212 through the open top 216. In some examples, a rib (not shown) may be provided on the bottom 120 of the lower portion 118 of the collection container 16, which engages with an anti-rotation structure of the stand 212 to resist rotation of the container 16 relative to the stand 212 while removing the cap (when inserted into the stand 212). Preferably, the rib is positioned so as not to be easily accessible to the user, making it unlikely that the user will attempt to grasp the rib or use the rib to apply torque to remove the upper portion 114 or cap from the lower portion 118. Instead, it is preferable that the ribs of the bottom 120 be positioned so as to be easily engaged only by the corresponding structure on the stand 212.

[0106] The cap removal assembly 210 also includes a cap remover 220 and a tool 218 having a handle 222 extending therefrom. The cap remover 220 includes a body defining an opening 224 or recess sized to receive the cap or upper portion 114 of the blood collection container 16, and at least one projection, such as a plong 226, extending from the body into the opening 224 or recess sized to engage with the upper portion 114 or part of the cap. For example, the plong 226 can be positioned to engage with and / or insert into the U-shaped rib 192 of the upper portion 114. Once the tool 218 engages with the upper portion 114 or cap, the user can rotate the upper portion 114 or cap relative to the lower portion 118 in the direction of arrow A1 (shown in Figure 5E) by applying rotational force to the handle 222 of the tool 218. As previously mentioned, the interface between the upper portion 114 or cap and the lower portion 118 is configured such that a small rotation of the upper portion 114 or cap (i.e., a quarter turn) will 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 of the container body 110, the upper portion 114 or cap can be removed by axially lifting it away from the lower portion 118.

[0107] In some examples, the body of the tool 218 is a ring 228 defining an opening 224 (i.e., a through hole or bore extending through the ring 228). In some examples, the cap remover 220 includes two projections, such as two protrusions 226 extending from the inner surface of the ring 228 into the opening 224. The protrusions 226 are positioned and dimensioned to contact a U-shaped rib 192 on the upper portion 114 or cap of the container 16 to facilitate the release of the upper portion 114 or cap from the lower portion 118. As shown in Figure 5D, in some examples, the protrusions 226 are positioned on the opposite side of the ring 228 such that a virtual line V1 passing between the protrusions 226 passes through the center C1 of the opening 224 defined by the ring 228. Furthermore, the protrusions 226 can be offset from the handle 222 of the tool 218 to allow the user to grip the tool 218 more comfortably. For example, the imaginary line V1 between the protrusions 226 can be tilted or angled by a small amount, such as about 5 degrees to about 25 degrees, preferably about 15 degrees, with respect to the longitudinal axis L1 of the handle 222.

[0108] To remove the upper portion 114 of the container body 110 or the cap from the lower portion 118 using the cap removal assembly 210, the user first places the collection container 16 containing the fluid sample in the stand 212, as shown in Figure 5A. As previously mentioned, the mechanical features of the collection container 16 and / or the stand 212 are provided to restrict the rotation of the collection container 16 relative to the stand 212. Next, the user inserts the cap remover 220 of the tool 218 onto the upper portion 114 or the cap of the collection container 16 and moves the cap remover 220 downward until the projection 226 is received within the U-shaped rib 192, as shown in Figure 5E. Once the cap remover 220 is properly positioned, the user can place their thumb on the top 116 of the upper portion 114 or the lid 130 to hold the collection container 16 in place and prevent the collection container 16 from being inadvertently lifted from the stand 212. When the user places their thumb on the upper portion 114 or the top 116 of the cap, the user applies rotational force to the handle 222 of the tool 218, thereby rotating the cap remover 220 a small amount (i.e., a quarter turn) in the direction of arrow A1 (Figure 5E), thereby releasing the upper portion 114 or the cap from the lower portion 118. Once the upper portion 114 or the cap is released from the lower portion 118, it can be removed by grasping the upper portion 114 or the cap and pulling it axially away from the lower portion 118.

[0109] In some examples, the ring 228 is sized such that the upper portion 114 or cap can be inserted through the opening 224 when the tool 218 is in either an upward or downward orientation. This allows both right-handed and left-handed people to use the tool 218. 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 onto the upper portion 114 or cap 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 onto 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 left-handed people.

[0110] Referring particularly to Figures 5B and 5C, in some examples, the tool 218 may include a pressing member 230 attached to the handle 222 and having a distal end 232 extending over the opening 224 of the remover 220. The pressing member 230 is positioned to press the top 116 of the upper portion 114 of the container 16 or the cap, meaning that the user does not need to rest their thumb on the upper portion 114 or the cap while rotating the tool 218. Similar to the user's thumb, the pressing member 230 prevents the container 16 from lifting off the stand 212 when the tool 218 and the upper portion 114 or the cap rotate relative to the lower portion 118 of the container body 110. The pressing member 230 can be attached to either the upper surface 234 or the lower surface 236 of the tool 218, depending on whether the user is right-handed or left-handed. For example, as shown in Figure 5C, 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 onto the container 16 in a downward orientation (i.e., left-handed orientation).

[0111] Various examples of sample containers, blood collection devices, and related tools are shown in the accompanying figures and described in detail above, but other examples will be obvious to those skilled in the art and will be readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is illustrative and not limiting. The invention as described above is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalents of the claims are included within that scope.

Claims

1. A blood collection container, A container body comprising a closed bottom portion of the container body, an open top portion of the container body, and an annular side wall portion of the container body extending between them, A cap detachable from the container body, comprising a bottom opening portion of the cap, a top opening portion of the cap, and an annular side wall portion of the cap extending between them, which are removably inserted into the top opening portion of the container body. A lid that is removably attached to the top of the opening of the cap, the lid being sized to press-fit the cap into the container body, and which restricts the rotation of the cap relative to the container body when fully fitted to the container body, A blood collection container equipped with the following features.

2. The blood collection container according to claim 1, wherein the container body comprises an annular flange portion extending radially outward from the outer surface of the annular side wall portion of the container body.

3. The blood collection container according to claim 2, wherein when the cap is inserted into the container body, the opening bottom of the cap contacts the annular flange portion of the container body to restrict the rotation of the cap relative to the container body.

4. The blood collection container according to claim 3, wherein the annular flange portion extending from the container body and the opening bottom portion of the cap are provided with corresponding inclined surfaces configured to align axially when the cap is inserted into the container body.

5. The blood collection container according to claim 4, wherein the rotation of the cap relative to the container body causes the inclined surface of the cap to slide along the inclined surface of the annular flange portion of the container body, thereby lifting the cap away from the container body.

6. The blood collection container according to claim 4, wherein the container body is provided with an annular projection extending radially outward from the outer surface of the annular side wall of the container body, and the inner surface of the annular side wall of the cap is provided with an annular recess for receiving the annular projection of the container body.

7. The blood collection container according to claim 6, wherein the annular projection extending from the container body comprises an inclined upper surface, a substantially flat lower surface, and a cylindrical peripheral portion extending between them.

8. The blood collection container according to claim 2, wherein the inner surface of the annular side wall of the container body is provided with a tapered portion that tapers radially inward from the top of the opening of the container body.

9. The blood collection container according to claim 8, wherein a tapered interlocking fit exists between the outer surface of the annular side wall portion of the container body and the inner surface of the annular side wall portion of the cap.

10. The aforementioned lid is The lid body and A flexible connecting part for connecting the lid body to the cap, wherein the flexible connecting part is configured to move the lid between a closed position where the lid covers the top of the opening of the cap and an open position where the top of the opening of the cap is not covered, When the lid is in the closed position, a punctureable partition attached to the lid body seals the top of the opening of the cap, The blood collection container according to claim 1, further comprising:

11. The blood collection container according to claim 10, wherein the punctureable partition comprises an inward-facing surface facing the interior of the container body and an outward-facing surface opposite to the inward-facing surface, the outward-facing surface comprising a recess or depression positioned to collect any fluid leaking from the interior of the container body while the needle is retracted through the partition.

12. The blood collection container according to claim 10, wherein the lid body comprises an annular flange portion defining an opening, the partition wall is inserted through the opening, and the annular flange portion is received within an annular notch portion of the partition wall.

13. The blood collection container according to claim 10, wherein the punctureable partition has an inward-facing surface that faces the inside of the container body when the lid is in the closed position, and the inward-facing surface of the partition has a chamfered periphery.

14. The blood collection container according to claim 13, wherein the inward-facing surface of the punctureable partition defines a central cavity that promotes radial deformation of the punctureable partition during centrifugation.

15. A cap removal assembly for removing the cap of a blood collection container according to claim 1 from the container body of the blood collection container, A stand configured to support the blood collection container in an upright position and to restrict the rotation of the container relative to the stand, A tool comprising a cap remover and a handle extending from the cap remover, wherein the cap remover comprises a body defining an opening or recess of a size for receiving the cap of the blood collection container, and at least one projection extending from the body into the opening or recess and positioned to engage with a portion of the cap, and the rotation of the tool relative to the cap releases the cap from the body of the container, A cap removal assembly comprising:

16. The cap removal assembly according to claim 15, wherein once the cap is released from the container body, the cap can be removed from the container body by lifting the cap axially away from the container body.

17. The cap removal assembly according to claim 15, wherein the body of the cap remover comprises a ring defining the opening, and the cap can be inserted through the opening when the tool is in either an upward or downward orientation.

18. The cap removal assembly according to claim 17, wherein the tool allows operation with the right hand when in the upward orientation and allows operation with the left hand when in the downward orientation.

19. The cap removal assembly according to claim 15, wherein the tool further comprises a pressing member attached to the handle and having a distal end extending beyond the opening of the cap remover, the pressing member being positioned to press the top of the cap when the cap is inserted through the opening, thereby preventing the container from lifting off the stand when the tool and the cap rotate relative to the container body.

20. The cap removal assembly according to claim 15, wherein the cap remover comprises two protrusions extending into the opening or the recess.

21. The cap removal assembly according to claim 20, wherein the two protrusions are arranged such that a virtual line passing between the two protrusions through the center of the opening or the recess is inclined with respect to the longitudinal axis of the handle.

22. The cap removal assembly according to claim 21, wherein the inclination is about 5 degrees to about 25 degrees, preferably about 15 degrees.

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