Capillary blood collection device

Abstract

The present invention aims to provide an integrated finger-based capillary blood collection device that has the ability to incise and compress a finger with a lancet under controlled conditions, collect a blood sample, stabilize it, and dispense it. [Solution] The present invention provides a holder for receiving a sample source, having an operating part and a port, A blood collection attachment is detachably connected to the holder, It comprises a collection container detachably connected to a blood collection attachment, which defines the collection space, This relates to a device for acquiring blood samples, wherein a release tab is provided between the blood collection attachment and the collection container, configured to push the collection container away from the blood collection attachment.

Description

Technical Field

[0001] Cross - reference to related documents This application claims priority to U.S. Provisional Application No. 63 / 216,252, entitled "Capillary Blood Collection Device," filed on June 29, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] This disclosure generally relates to devices for obtaining biological samples. More particularly, this disclosure relates to an integrated finger - based capillary blood collection device having the ability to lance and squeeze a finger in a controlled manner to collect, stabilize, and dispense a blood sample.

Background Art

[0003] Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One well - known blood collection method in the medical field is capillary blood collection, which is often performed to collect a blood sample for testing. Certain diseases, such as diabetes, require, for example, that a patient's blood be regularly tested to monitor their blood sugar level. In addition, test kits, such as cholesterol test kits, often require a blood sample for analysis. Blood collection procedures typically involve puncturing a finger or other suitable body site with a needle to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture or incision usually provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed for puncturing a patient's skin to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available to individual consumers as well as to hospitals, clinics, and examination rooms. Such devices typically involve a pointed component, such as a needle, or a sharp component, such as a blade, used to create a rapid puncture or incision in the patient's skin to allow a small outflow of blood. Often, puncturing one's own finger with a handheld needle or blade is physiologically and psychologically difficult for many people. As a result, 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 ready position until it is released by the user, for example, a healthcare professional responsible for drawing blood from the patient, or the patient themselves. Upon release, the needle or blade punctures or cuts the patient's skin, for example, the skin of a finger. Often, a spring is incorporated into the device to provide the "automatic" force necessary to puncture or cut the patient's skin.

[0005] One contact-actuated lancet device, characterized by the automatic deployment and retraction of a puncture or cutting element from or into the device, is U.S. Patent No. 9,380,975, owned by the present applicant, Becton, Dickinson and Company. This lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is housed within the housing and can accommodate movement between a pre-retaining or pre-actuated position in which the puncture element is held within the housing and a puncture position in which the puncture element protrudes through the front end of the housing. The lancet device includes a drive spring housed within the housing for biasing the lancet structure to the puncture position, and a retaining hub for holding the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivot lever engaged with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure to the rear end of the housing, at least partially compressing the drive spring and releasing the lever from engagement with the lancet structure. Next, the collected blood sample is collected and / or tested. This test can be performed using a point-of-care (POC) testing device, or it can be collected and sent to a testing facility.

[0006] Currently, capillary blood collection workflows are complex, multi-step processes requiring a high level of technical skill. The multi-step nature of this process introduces several variations that can lead to sample quality issues such as hemolysis, sample instability, and microclotting. While the use of lancet devices for acquiring blood samples is not limited to capillary blood sample collection, it results in variations in the impact of capillary blood sample collection, including keeping the lancet stationary during the examination, obtaining sufficient blood flow from the puncture site, and properly collecting blood while preventing clots. Some of the most common causes of process variation include (1) improper lancet incision site cleaning and initial deposit removal, which may result in contaminated samples; (2) inconsistent lancet incision site and depth, which may result in insufficient sample volume and a large proportion of interstitial fluid; (3) inconsistent compression techniques and excessive pressure near the lancet incision site to facilitate hemolysis (e.g., hemomilking), which may result in hemolyzed samples; (4) variable migration interfaces and collection techniques, which may result in hemolyzed or contaminated samples; and (5) improper sample mixing with anticoagulants, which may result in microclots.

[0007] Capillary blood collection is typically performed by healthcare professionals using their fingers to manually compress the tissue around the puncture site or by aspirating blood from that location using a vacuum-operated device.

[0008] Manually compressing the collection site is a highly technical method that results in very large variability in the success rate and sample quality (as measured by hemolysis-blood cell rupture). Healthcare workers typically adjust the pressure and speed of compression to compensate for patient-dependent differences in blood flow. Increasing the intensity of compression helps to increase blood flow, but it also increases hemolysis. The compression site varies among healthcare workers, depending on personal preference, experience, and hand fatigue. Some workers may perform so-called "finger milking," applying pressure by starting from the base of the finger and sliding towards the fingertip. This method is not recommended by national and international healthcare organizations due to its tendency to result in lower sample quality.

[0009] Vacuum-driven devices standardize blood flow pressure and technique, but are typically plagued by low overall blood flow. The maximum pressure that can be applied is limited by the difference between atmospheric pressure and absolute vacuum (~14 psi), and the device only operates within a portion of absolute vacuum. For reference, the average grip strength of men and women ranges from 50-100 lbs, illustrating why manual methods are more affected by hemolysis than flow. Vacuum methods apply a constant pressure, limiting the tissue's ability to replenish blood.

[0010] Therefore, there is a need in the art for a device capable of controlling the incision and compression of a finger with a lancet, collecting a sample, stabilizing the sample, and then dispensing the sample. There is also a need in the art for a device that simplifies and streamlines capillary blood collection by eliminating workflow variability typically associated with low sample quality, including hemolysis and microclots. Furthermore, there is a need in the art for closed-system collection and transport that eliminates blood exposure and device reuse. Furthermore, a device is needed in the art that (1) provides flexibility in housing containers for collecting and transferring different capillary blood samples, (2) has the ability to produce high-quality, uniformly mixed / stabilized capillary blood samples, (3) has the ability to generate onboard plasma from capillary plasma samples, (4) has the ability to collect large amounts of capillary blood samples (>50-500 μL) with reduced pain, (5) includes a unique sample identifier paired with patient information at the time of collection, (6) has the ability to collect capillary blood and perform onboard diagnostics, and (7) has multiple collection ports for collecting blood samples into different containers with the same or different anticoagulants. Capillary blood collection devices are further needed in the art that allow for the application of pressure in a standardized and controlled position, the application of pressure that is sufficiently high for sufficient blood flow but lower than the hemolysis threshold, the application of pressure in a defined rhythm rather than a constant pressure that allows for finger blood replenishment, increasing the average blood flow velocity, and reducing user fatigue by reducing the maximum force applied by the operator. [Overview of the project]

[0011] This disclosure relates to devices for obtaining biological samples, such as capillary blood collection devices, which, in a controlled manner, incis and compress a finger with a lancet to collect a sample, stabilize the sample, and subsequently dispense the sample, thereby meeting the requirements specified above. The devices also simplify and streamline capillary blood collection by eliminating workflow variability, particularly associated with low sample quality, including hemolysis and microclots.

[0012] This disclosure includes a self-contained and fully integrated finger-based capillary blood collection device capable of dissecting with a lancet and collecting and stabilizing high-volume capillary blood samples, e.g., up to 500 microliters or more. The device simplifies and streamlines high-volume capillary blood collection by eliminating workflow steps and variability particularly associated with low sample quality, including hemolysis, microclots, and patient discomfort. The device features a retractable lancet dissection mechanism that can dissect the finger and associated blood flow path to ensure attachment and transfer of capillary blood from the punctured finger site to the collection container. The device also includes a holder that can be periodically squeezed to stimulate, i.e., pump, the blood flow out of the finger, and further includes an anticoagulant deposited in the flow path or collection container to stabilize the collected sample.

[0013] In one embodiment, the device may comprise separate components such as a holder, a lancet, and a collection container. In another embodiment, the lancet and collection container can be integrated into a single device used together with the holder. In yet another embodiment, the holder, lancet, and collection container can be integrated into a single system. Any of these embodiments is envisioned to be used as a self-contained, disposable device and / or in conjunction with an external power source for pain reduction control. The capillary blood collection device can serve as a platform for a variety of capillary blood collection containers, ranging from small tubes to capillary dispensers, as well as for onboard plasma separation modules. This capability extends product flexibility to a variety of applications, including dispensing to point-of-care (POC) cartridges or to small collection tube transfers that can be used with centrifuges or analytical instruments.

[0014] According to one embodiment of the present disclosure, a device for acquiring a blood sample may comprise: a holder for receiving a sample source having an actuation unit and a port; a blood collection attachment detachably connected to the holder; and a collection container detachably connected to the blood collection attachment, defining a collection space, wherein a collection container detachment member is provided between the blood collection attachment and the collection container to detachably mount the collection container to the collection attachment.

[0015] According to one embodiment of the present disclosure, the collection container may include a lid with a release tab that releases a blood collection attachment from the collection container when pressed. The lid may be coupled to the collection container via a living hinge. The blood collection attachment may include a protrusion, and the lid may define a recess to receive the protrusion, thereby locking the collection container in the blood collection attachment. The living hinge may be reduced in thickness or have at least one cutout. The lid may include at least one guide tab to ensure the lid is in a desired position on the collection container when the lid is closed. The collection container may include aligned protrusions extending from the outer surface of the collection container, and the blood collection attachment may define aligned slots on the inner surface of the blood collection attachment to position the collection container in a desired position when inserted into the blood collection attachment. A rotatable coupling assembly may be provided between the holder and the blood collection attachment. The rotatable coupling assembly may be positioned so that the collection container rotates relative to the holder between a filled position and a storage position. The rotatable coupling assembly may include a socket and a post member held together via a friction fit.

[0016] In one embodiment of the present disclosure, the device for acquiring a blood sample may comprise: a blood collection attachment; and a collection container detachably connected to the blood collection attachment, defining a collection space, wherein a collection container detachment member is provided between the blood collection attachment and the collection container to detachably attach the collection container to the collection attachment.

[0017] In one embodiment of the present disclosure, the collection container may include a lid with a release tab that releases a blood collection attachment from the collection container when pressed. The lid may be connected to the collection container via a living hinge. The blood collection attachment includes a protrusion, and the lid locks the collection container into the blood collection attachment by defining a recess that receives the protrusion. The living hinge may be reduced in thickness or have at least one cutout. The lid may include at least one guide tab to ensure the lid is in a desired position on the collection container when the lid is closed. The collection container may include aligned protrusions extending from the outer surface of the collection container, and the blood collection attachment may define aligned slots on the inner surface of the blood collection attachment to align the collection container in a desired position when inserted into the blood collection attachment. The blood collection attachment may define a relief recess to provide a position for the user's hand to grasp when using the device. When using the device, a recess may be defined in the blood collection attachment above the release tab that receives the user's thumb. When the collection container is held in the blood collection attachment, the lid may be sham-held in the blood collection attachment.

[0018] This disclosure is also defined by the following terms:

[0019] Clause 1: A holder for receiving a sample source, having an operating part and a port, A blood collection attachment is detachably connected to the holder, The system comprises a collection container that defines a collection space and is detachably connected to the blood collection attachment, A device for obtaining a blood sample, wherein a collection container detachment member is provided between the blood collection attachment and the collection container, allowing the collection container to be detachably attached to the blood collection attachment.

[0020] Clause 2: The device according to clause 1, wherein the collection container comprises a lid including a release tab that releases the collection container from the blood collection attachment when pressed.

[0021] Clause 3: The device according to clause 2, wherein the lid comprises an elastomer that acts as a locking function preloaded with a spring to create resistance with the collection container.

[0022] Clause 4: The device according to any one of clauses 2 - 3, wherein the lid is connected to the collection container via a living hinge.

[0023] Clause 5: The device according to any one of clauses 2 - 4, wherein the blood collection attachment comprises a convex portion, and the lid defines a concave portion for receiving the convex portion to lock the collection container within the blood collection attachment.

[0024] Clause 6: The device according to either clause 3 or 4, wherein the living hinge has a reduced thickness or at least one cut - out.

[0025] Clause 7: The device according to any one of clauses 2 - 6, wherein the lid comprises at least one guide tab to securely position the lid on the collection container when the lid is closed.

[0026] Clause 8: The device according to any one of clauses 1 - 7, wherein the collection container comprises aligned protrusions extending from an outer surface of the collection container, and the blood collection attachment defines aligned slots on an inner surface of the blood collection attachment to align the collection container in a desired position when inserted into the blood collection attachment.

[0027] Clause 9: The device according to any one of clauses 1 - 8, wherein a rotatable connection assembly is provided between the holder and the blood collection attachment.

[0028] Clause 10: The device according to clause 9, wherein the rotatable connection assembly is arranged such that the collection container rotates between a filling position and a storage position relative to the holder.

[0029] Clause 11: The device according to any one of clauses 9 to 10, wherein the rotatable connection assembly comprises a socket and a post member held together via a friction fit.

[0030] Clause 12: The device according to any one of clauses 1 to 11, wherein the collection container detachment member provides tactile feedback when the collection container is removed from the blood collection attachment.

[0031] Clause 13: A device for obtaining a blood sample, comprising: a blood collection attachment; and a collection container removably connected to the blood collection attachment and defining a collection space, wherein a collection container detachment member is provided between the blood collection attachment and the collection container to removably attach the collection container to the collection attachment.

[0032] Clause 14: The device according to clause 13, wherein the collection container comprises a lid including a release tab that releases the collection container from the blood collection attachment when pressed.

[0033] Clause 15: The device according to clause 14, wherein the lid comprises an elastomer that functions as a lock feature preloaded with a spring to create resistance with the collection container.

[0034] Clause 16: The device according to any one of clauses 14 to 15, wherein the lid is connected to the collection container via a living hinge.

[0035] Clause 17: The device according to any one of clauses 13 to 16, wherein the blood collection attachment comprises a protrusion, and the lid defines a recess for receiving the protrusion to lock the collection container within the blood collection attachment.

[0036] Clause 18: The living hinge is a device according to any one of Clauses 13 to 17, which has reduced thickness or has at least one cutout.

[0037] Clause 19: The device according to any one of Clauses 13 to 18, wherein the lid is provided with at least one guide tab to ensure that the lid is in the desired position on the collection container when the lid is closed.

[0038] Clause 20: The device according to any one of Clauses 13 to 19, wherein the collection container comprises aligned protrusions extending from the outer surface of the collection container, and the blood collection attachment defines aligned slots on the inner surface of the blood collection attachment to position the collection container in a desired position when inserted into the blood collection attachment.

[0039] Clause 21: The device according to any one of Clauses 13 to 20, wherein the blood collection attachment defines a removed recess to provide a position for the user's hand to grasp when using the device.

[0040] Clause 22: The device according to any of Clauses 13 to 21, wherein a recess is defined in the blood collection attachment above the release tab for receiving the user's thumb when the device is in use.

[0041] Clause 23: The device according to any one of Clauses 13 to 22, wherein the lid is sham to be held in the blood collection attachment when the collection container is held in the blood collection attachment.

[0042] Clause 24: The device according to any one of Clauses 13 to 22, wherein the collection container detachment member provides tactile feedback when the collection container is removed from the blood collection attachment. [Brief explanation of the drawing]

[0043] [Figure 1] Figure 1 is a perspective view of a holder according to an embodiment of the present invention. [Figure 2A] Figure 2A is a cross-sectional view of a device and lancet for obtaining a blood sample from a patient's finger according to another embodiment of the present disclosure. [Figure 2B] Figure 2B is a perspective view of a device and collection container for obtaining a blood sample from a patient's finger according to another embodiment of the present disclosure. [Figure 3] Figure 3 is a side view of a device and sample collection container for obtaining a blood sample from a patient's finger according to another embodiment of the present disclosure. [Figure 4] Figure 4 is a perspective view of an unlocked collection container detachment member. [Figure 5] Figure 5 is a perspective view of the collection container from Figure 4 after it has been detached. [Figure 6] Figure 6 is another perspective view of the collection container from Figure 4 in its detached state. [Figure 7] Figure 7 is a cross-sectional view of a blood collection attachment and collection container according to one embodiment of the present disclosure. [Figure 8] Figure 8 is a magnified view of the collection container shown in Figure 7. [Figure 9] Figure 9 is a perspective view of the collection container detachment member. [Figure 10] Figure 10 is a perspective view of a collection container and a user's hand according to one embodiment of the present disclosure. [Figure 11] Figure 11 is a cross-sectional view of a device and collection container for obtaining a blood sample from a patient's finger according to another embodiment of the present disclosure. [Figure 12] Figure 12 is a side view of the device shown in Figure 11. [Figure 13] Figure 13 is a front view of the device shown in Figure 11. [Figure 14] Figure 14 is a cross-sectional view of the collection container detachment member. [Figure 15] Figure 15 is a side view of a collection container according to one embodiment of the present disclosure. [Figure 16]Figure 16 is a top view of a collection container according to one embodiment of the present disclosure. [Figure 17] Figure 17 is a top view of a collection container according to one embodiment of the present disclosure. [Figure 18] Figure 18 is a perspective view of a collection container having a guide tab according to one embodiment of the present disclosure. [Figure 19] Figure 19 is a perspective view of a collection container and a blood collection attachment having consistent features according to one embodiment of the present disclosure. [Figure 20] Figure 20 is a perspective view of a collection container and a blood collection attachment having consistent features according to one embodiment of the present disclosure. [Figure 21] Figure 21 is a side view of a rotatable connector assembly for a holder according to one embodiment of the present disclosure. [Figure 22] Figure 22 is a cross-sectional view of the rotatable connector assembly shown in Figure 21. [Figure 23] Figure 23 is a cross-sectional view of an alternative rotatable connector assembly. [Modes for carrying out the invention]

[0044] The following description is provided to enable those skilled in the art to manufacture and use the described embodiments intended for carrying out the present invention. However, various modifications, equivalents, variations, and substitutions will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0045] For the purposes of the following description, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives will be relevant to the present invention as they are oriented in the drawings. However, it should be understood that the present invention may envision various alternative modifications unless explicitly specified otherwise. Furthermore, it should be understood that the particular apparatus shown in the accompanying drawings and described in the following specification is merely an illustrative embodiment of the present invention. Accordingly, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0046] This disclosure relates to a device for acquiring biological samples, such as a capillary blood collection device, that meets the above needs and has the ability to incise and compress a finger with a lancet, collect a sample, stabilize the sample, and consequently distribute the sample in a controlled manner. The device also simplifies and streamlines capillary blood collection by eliminating workflow variability typically associated with low sample quality, including hemolysis and microthrombi.

[0047] Blood collection is fundamentally driven by pressure-driven flow. The device or technology either reduces the pressure outside the blood vessel (vacuum flow) or increases the pressure inside the blood vessel. Both approaches increase the pressure difference between the vascular and external pressures and increase the flow velocity from inside the vessel to the outside where the collection container is located. The location of compression can also be important, as hard tissues and joints have poor perfusion or are mechanically stable and can be compressed without causing pain to the patient, while soft tissues (e.g., fat, skin, and muscle) allow blood to perfuse.

[0048] Red blood cells (RBCs) can be subjected to hemolysis during collection. Hemolysis (RBC destruction) contaminates the sample for diagnostic analysis by both allowing cellular contents to flow into the liquid serum of the sample and by coloring the serum red via hemoglobin, thereby interfering with the colorimetric reaction. The amount of hemolysis during collection can be caused by shearing destruction of cells, as well as by pressure-driven hemolysis, where the flow rate and channel, and the physical compression of tissues and blood vessels, can damage cells. Therefore, hemolysis can be controlled by checking the pressure applied and ensuring that the flow is not too fast at any point where the finger is compressed.

[0049] This disclosure includes a self-contained, fully integrated finger-based capillary blood collection device capable of dissecting with a lancet, collecting high-volume (e.g., up to or exceeding 500 microliters) capillary blood samples, and stabilizing them. The device simplifies and streamlines high-volume capillary blood collection by eliminating workflow steps and variability typically associated with low sample quality, including hemolysis, microclots, and patient discomfort. The device comprises a retractable lancening mechanism for dissecting a finger with a lancet, and associated blood channels to ensure the movement of capillary blood from the fitted and punctured finger to a collection container. The device also includes a holder that can be periodically squeezed to stimulate, i.e., pump, the blood flow out of the finger, and further includes an anticoagulant deposited in the channel or collection container to stabilize the collected sample.

[0050] In one embodiment, the device may comprise separate components such as a holder, a lancet, and a collection container. In another embodiment, the lancet and collection container may be integrated into a single device used together with the holder. In yet another embodiment, the holder, lancet, and collection container may be integrated into a single system. Any of these embodiments is envisioned to be used as a self-contained, disposable device and / or in conjunction with an external power source for pain reduction control. The capillary blood collection device can serve as a platform for a variety of capillary blood collection containers, ranging from small tubes to capillary dispensers, as well as for onboard plasma separation modules. This capability extends product flexibility to a variety of applications, including dispensing to point-of-care (POC) cartridges or to small collection tube transfers that may be used with centrifuges or analytical instruments.

[0051] Referring to Figures 1 and 2A, in an exemplary embodiment, the device (10) of the Disclosure comprises separate components, for example, a holder (12) (as shown in Figure 1), a lancet housing or lancet (as shown in Figure 2A), and a collection container (16) (as shown in Figure 2B). In another exemplary embodiment, the semi-integrated device of the Disclosure may include at-angle flow and comprises an integrated lancet housing and a collection container that can be connected to a separate holder. In another exemplary embodiment, the semi-integrated device of the Disclosure may have in-line flow and comprises an integrated lancet housing and a collection container that can be connected to a separate holder. In another exemplary embodiment, the integrated device of the Disclosure may have at-angle flow and comprises an integrated holder, a lancet housing, and a collection container. In another exemplary embodiment, the integrated device of the Disclosure may have in-line flow and comprises an integrated holder, a lancet housing, and a collection container.

[0052] Referring to Figure 1, exemplary embodiments of a holder (12) of the present disclosure capable of receiving a sample source, for example, a finger (19) supplying a biological sample such as a blood sample (18), are shown and described. The holder (12) of the present disclosure generally comprises a port (26) having a first opening (22) (Figure 1), an actuation part (24), a second opening (28), and a fingertip guard (30). In one embodiment, the fingertip guard (30) provides a stopper within the holder (12) for suitably aligning and securing the finger (19). The fingertip guard (30) further assists in ensuring that the patient's finger (19) is suitably positioned within the finger receiving part (20) and that the pressure applied to the patient's finger (19) generates sufficient blood flow.

[0053] The first opening (22) of the finger receiving portion (20) is positioned to receive a finger (19) that supplies a sample source, such as a biological sample, like a blood sample (18). Some sample sources may be considered to have other body parts that can fit within the first opening (22). A port (26) communicates with the finger receiving portion (20). For example, the port (26) communicates with a finger (19) received in the holder (12) at a portion of the finger (19). The holder (12) of this disclosure is resizable to accommodate all finger sizes.

[0054] The second opening (28) of the port (26) is positioned to receive the lancet housing (14) and the collection container (16), as will be described in more detail below. In one embodiment, the port (26) includes a locking section (32) within the port (26) for securing and receiving the lancet housing (14) and the collection container (16).

[0055] In one embodiment, the actuarial unit (24) is movable between a first position in which the holder (12) defines a first diameter and a second position in which the holder (12) defines a second diameter, the second diameter being smaller than the first diameter. In one embodiment, the actuarial unit (24) is movable between a first position in which a first ellipse is defined and a second position in which a second ellipse is defined, the first ellipse being different from the second ellipse. In this way, together with the holder (12) in the second portion of the reduced diameter, the holder (12) comes into contact with a sample source, and the actuarial unit (24) of the holder (12) can pump or extract blood (18) as described in more detail below.

[0056] Referring to Figure 1, in one embodiment, the actuator (24) comprises a contact member (34). Together with the actuator (24) in a first position, the contact member (34) is in a disengaged position, i.e., the contact member (34) is provided in the first position with respect to a sample source, e.g., a finger (19), and the contact member (34) may make slight contact with it there. Together with the actuator (24) in a second position, the contact member (34) is in an engaged position, i.e., the contact member (34) is provided in the second position with respect to a sample source, e.g., a finger (19), and the contact member (34) makes contact with the finger (19) under applied pressure, and the actuator (24) of the holder (12) is able to pump or extract blood (18). For example, together with the contact member (34) in the engaged position, the contact member (34) exerts pressure on the sample source.

[0057] Referring to Figure 1, in one embodiment, the actuarial unit (24) comprises a pressurizing member (36) for applying pressure to a sample source, such as a finger (19). In one embodiment, the pressurizing member (36) comprises a pair of opposing tabs or wings (38). In such an embodiment, each tab (38) may comprise a contact member (34). In one embodiment, the holder (12) comprises a living hinge (42). The living hinge (42) allows the user to compress the wings (38) between a first position (passive state) and a second position (active state). Blood collection (18) from the patient's finger (19) using the tabs or wings (38) minimizes hemolysis while maintaining sufficient blood flow from the patient's finger (19). The resting position and the hinges of the wings (38) are designed to be flexible enough to accommodate the largest patient's finger within the holder (12) without obstructing blood flow, while maintaining contact and ensuring that the smallest patient's finger fits within the holder (12).

[0058] Advantageously, the holder (12) of the present disclosure allows the user to repeatedly squeeze and / or extract blood (18) from the finger (19) until a desired amount of blood (18) fills the collection container (16). The wings (38) are flexibly positioned to maintain a size and gentle contact with the patient's finger on which the holder (12) may be used, and to maintain the holder (12) on the patient's finger (19).

[0059] Advantageously, together with the holder (12) positioned on the finger (19), the holder (12) does not restrict blood flow and defines the lance and finger compression positions. The compression tab or wing (38) provides a defined range of compression pressure that is consistently applied through the finger (19). In doing so, the holder (12) provides a gentle, controlled finger massage that promotes blood extraction and minimizes potential hemolysis.

[0060] Referring to Figure 1, in one embodiment, the holder (12) includes a stabilizing extension (40), which provides additional support to the holder (12) to allow it to be fixedly positioned on the finger (19). In one embodiment, the finger receiving portion (20) generally forms a C-shaped member and includes multiple internal gripping members to provide additional grip and support for the holder (12) to allow it to be fixedly positioned on the 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).

[0061] In one embodiment, the finger receiving portion (20) is formed from a flexible material. In some embodiments, the finger receiving portion (20) and the port (26) are formed from a flexible material.

[0062] The device for acquiring a blood sample according to this disclosure comprises a lancet housing or lancet (14) detachably connected to a port (26) of a holder (12). In some embodiments, the lancet housing (14) comprises an inlet or opening (50), an interior (52), a puncture element (54), an engagement portion (56), a retractable mechanism (58), and an activation spring (60). In one embodiment, the puncture element (54) is 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 inlet (50) of the lancet housing (14) to cut a portion of a finger (19) with the lancet.

[0063] In one embodiment, the lancet (14) of this disclosure is a contact-activated lancet, which may be configured in accordance with the features disclosed in U.S. Application No. 2006 / 0052809, filed on 6 May 2005 and titled “Contact-Activated Lancet Device,” the entire disclosure of which is incorporated herein by reference.

[0064] In one embodiment, the lancet housing (14) may be a separate component from the holder (12) and the collection container (16). In some embodiments, the collection container (16) and the lancet housing (14) form a single component that is detachably connected to the port (26) of the holder (12). In some embodiments, the collection container (16), the lancet housing (14), and the holder (12) form a single component.

[0065] Referring to Figure 2A, in one embodiment, the lancet housing (14) is a separate component from the holder (12), and is therefore detachably connected to the port (26) of the holder (12). In such an embodiment, the lancet housing (14) includes an engaging portion (56). Referring to Figure 2A, in one embodiment, the lancet housing (14) is pressed into the port (26) of the holder (12), and the engaging portion (56) of the lancet housing (14) is locked in the locking portion (32) of the holder (12). In this way, the lancet housing (14) is securely connected to the holder (12) and locked, and the puncture element (54) of the lancet housing (14) can be activated to cut or puncture a sample source, such as a finger (19), with the lancet. In some embodiments, the port (26) of the holder (12) is provided with a number of ribs at the port (26) for securing and locking the lancet (14) or collection container (16).

[0066] To activate the lancet (14), the lancet (14) is pressed against the finger (19), activating the retractable mechanism (58) of the lancet (14) that cuts the finger (19) with the lancet. The lancet (14) of this disclosure provides a precise lancet cutting depth and a predetermined lancet cutting position, thus ensuring a sufficient amount of sample.

[0067] In one embodiment, the lancet (14) includes an activation spring located inside (52) of the lancet housing (14) to bias the puncture element (54) toward the puncture position. After puncture, the puncture element (54) is immediately retracted inside (52) of the lancet housing (14) and securely fixed.

[0068] In one embodiment, the lancet (14) of the present disclosure is used to lancet-cut the skin of a finger (19), and then a blood sample (18) is compressed into a collection container (16), as described in detail below.

[0069] In one embodiment, the lancet (14) of the present disclosure is used to make an incision in the skin of a finger (19) along the lancet pathway, and thereafter, as described in detail below, a blood sample (18) is used to flow inclined toward the lancet pathway.

[0070] In one embodiment, the lancet (14) may be equipped with a hollow needle. In such an embodiment, the lancet housing (14) of the present disclosure is used to incise the skin of a finger (19) with the lancet along the lancet path, and then a blood sample (18) (shown in Figure 2B) is used to flow through the hollow needle in a parallel blood flow path.

[0071] As shown in Figure 2B, the device for acquiring a blood sample (18) according to this disclosure comprises a collection container (16) detachably connected to a port (26) of a holder (12). The collection container (16) defines a collection space (70) for receiving the blood sample (18), a container engagement portion (72), a blood collection portion (74), and a cap or septum (76). Once the desired amount of blood (18) has been collected in the collection container (16), the blood collection portion (74) is detached from the collection device (10) to send the blood sample (18) to a diagnostic instrument and / or test device. Once removed from the collection device (10) and sealed to protect the blood sample (18) within the collection space (70), the blood collection portion (74) is sealed via the cap or septum (76).

[0072] In one embodiment, the collection container (16) may be a separate component from the holder (12) and the lancet housing (14). In some embodiments, the collection container (16) and the lancet housing (14) form a single component that is detachably connected to the port (26) of the holder (12). In some embodiments, the collection container (16), the lancet housing (14), and the holder (12) form a single component.

[0073] In one embodiment, the collection container (16) is detachably connected to the port (26) of the holder (12), as the collection container (16) is a separate component from the holder (12). In such an embodiment, the collection container (16) includes a container engagement portion (72). In one embodiment, the collection container (16) is pressed into the port (26) of the holder (12), causing the container engagement portion (72) of the collection container (16) to lock within the lock portion (32) of the holder (12). In this way, the collection container (16) is securely connected to and locked in the holder (12), allowing the blood sample (18) to safely flow from the finger (19) into the collection space (70) of the collection container (16) within the holder (12).

[0074] It may be understood that several types of collection containers (16) can be used with the device (10) of this disclosure. The collection containers (16) can be coupled with separate dispensing units, or the collection containers (16) can have an integrated dispensing unit for dispensing blood (18) to the test device.

[0075] Referring to Figure 1, the use of the device (10) of this disclosure having separate components, for example, a holder (12), a lancet housing or lancet (14), and a collection container (16), will now be described.

[0076] Referring to Figure 1, first, the desired finger (19) is cleaned, and a holder (12) of a suitable size for the desired finger (19) is selected and firmly positioned on the finger (19). Next, referring to Figure 2A, the lancet housing (14) is connected to the port (26) of the holder (12). As discussed above, the lancet housing (14) is pressed into the port (26) of the holder (12) so that the engaging portion (56) of the lancet housing (14) is locked in the locking portion (32) of the holder (12). In this way, the lancet housing (14) is firmly connected to and locked in the holder (12), and the puncture element (54) (Figure 2A) of the lancet housing (14) can be activated to incise or puncture a sample source, such as a finger (19), with the lancet. The lancet (14), connected to the port (26) of the holder (12), is in communication with the finger (19).

[0077] When it is desired to activate the lancet and incise the skin of the finger (19) with the lancet, the lancet (14) is pressed against the finger (19) to activate the retractable mechanism (58) (Figure 2A) of the lancet (14) and incise the finger (19) with the lancet. The lancet (14) of this disclosure provides a precise puncture depth and a predetermined puncture location, and therefore ensures a sufficient sample volume.

[0078] After the finger (19) is incised with a lancet to allow blood flow (18) to occur 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). Referring to Figure 2B, as the collection container (16) is pushed into the port (26) of the holder (12), the container engagement portion (72) of the collection container (16) is locked in the lock portion (32) of the holder (12). In this way, the collection container (16) is securely connected to and locked in the holder (12), and the blood sample (18) can safely flow from the finger (19) into the collection space (70) of the collection container (16) within the holder (12).

[0079] Referring to Figure 1, a holder (12) for collecting a blood sample (18) is suitably fixed to a collection container (16), allowing the user to repeatedly squeeze and release the wings (38) of the holder (12) to pump and / or extract blood (18) from the finger (19) until a desired amount of blood (18) fills the collection container (16). Conveniently, with the holder (12) positioned on the finger (19), the holder (12) does not obstruct blood flow and is incised with a lancet to define the position for finger compression. The compression tab or wings (38) provide a defined range of compression pressure that is consistently applied through the finger (19). In doing so, the holder (12) provides a gentle, controlled finger (19) massage that facilitates blood extraction and minimizes potential hemolysis.

[0080] For example, referring to Figure 1, in one embodiment, the actuator (24) comprises a contact member (34). In the actuator (24) in a first position, the contact member (34) is in a detached position, i.e., the contact member (34) is in a first position with respect to a sample source, e.g., a finger (19). In the actuator (24) in a second position, the contact member (34) is in an engaged position, i.e., the contact member (34) is in a second position and is in contact with a sample source, e.g., a finger (19), and pressure is applied, and the actuator (24) of the holder (12) can pump and / or extract blood (18). For example, together with the contact member (34) in the engaged position, the contact member (34) applies pressure to the sample source.

[0081] Once the desired amount of blood (18) has been collected in the collection container (16), the blood collection unit (74) is removed from the collection device to send the blood sample (18) to the diagnostic instrument and / or test device. Once removed from the collection device (10) and sealed to protect the blood sample (18) within the collection space (70), the blood collection unit (74) is sealed via a cap or septum (76).

[0082] The devices of this disclosure can be adapted with any known test devices, whether the test device is remote or in-situ. A variety of in-situ test devices are known in the art. Such in-situ test devices include test strips, slides, diagnostic cartridges, or other test devices for testing and analysis. Test strips, slides, and diagnostic cartridges are in-situ test devices that receive blood samples and test one or more physiological and biochemical states of that blood. There are many in-situ test devices that use a cartridge-based structure to analyze very small amounts of blood, eliminating the need to send samples to a laboratory for analysis. This saves time in obtaining results over long periods and allows for different types of experimentation in a highly standardized experimental environment. Specific examples of such test cartridges include the i-STAT® test cartridge from Abbot Group companies. Test cartridges such as the i-STAT® test cartridge can be used to test under a variety of test conditions, including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. Test results using such cartridges are immediately provided to the physician.

[0083] The collection container (16) may also include a sample stabilizer, such as an anticoagulant that stabilizes the blood sample (18) and / or the components of the blood sample (18) placed therein. The collection container (16) may include at least one fill-up line corresponding to a predetermined amount of sample. The collection container may also indicate / measure the blood collection volume.

[0084] Any device for acquiring blood samples according to the Disclosure may be used as a self-contained, disposable device and / or in conjunction with an external power source for pain reduction control. For example, a portion of the holder (12) may include an implanted electrode that receives a signal from an external pain control module and transmits at least one of thermal, vibrational, or transcutaneous electrical nerve stimulation (TENS) for pain reduction control. A device for acquiring blood samples according to the Disclosure may include a variety of options for onboard plasma separation. Any device for acquiring blood samples according to the Disclosure may include a unique sample identifier that can be paired with patient information at the time of collection. A device for acquiring blood samples according to the Disclosure may include onboard diagnostic feedback at the time of collection. A device for acquiring blood samples according to the Disclosure may use multiple collection ports to allow for two collections, for example, the collection of multiple samples from the same source, and processing the samples with different sample stabilizers such as anticoagulants, and allowing for the collection of two samples into separate containers.

[0085] The device for acquiring blood samples according to this disclosure is highly simplified and eliminates the need for large-volume capillary blood collection from the finger, compared to conventional capillary blood collection using lancets and capillaries. The device according to this disclosure eliminates blood exposure and prevents device reuse.

[0086] The device for obtaining blood samples according to this disclosure simplifies, eliminates, and streamlines the collection process. This is all achieved by a self-sufficient closed system device that, once placed on the finger, provides lancet-assisted incision, blood extraction, stabilization, and sealing functions all in one unit.

[0087] The device for obtaining blood samples according to this disclosure may be associated with a self-contained unit that provides automated pumping, controlled finger compression, and automated sample labeling and processing.

[0088] Referring to Figure 3-5, a collection container detachment member (80) is shown and described in detail according to one embodiment of the present disclosure. The collection container detachment member (80) may be an easy-to-use release mechanism that allows the user to press the member (80) to release it, thereby releasing the collection container (16) from the holder (12) which is detachably connected to the blood collection attachment (82). The collection container detachment member (80) provides the user with tactile feedback indicating that the collection container (16) has been removed from the blood collection attachment (82).

[0089] Referring to Figure 6, according to one embodiment of the present disclosure, the collection container detachment member (80) may include a release tab (84) that allows the user to detach the collection container (16) from the blood collection attachment (82). In one embodiment, the release tab (84) may be pushed inward by the user to release the collection container (16) from the blood collection attachment (82) after a blood sample (18) has been taken from the patient. When the release tab (84) is pushed by the user, the collection container (16) can be separated from the blood collection attachment (82). The release tab (84) may include a latching function to prevent contamination of the surface in contact with the blood sample (18) in the collection container (16). Since the release tab (84) must be actively engaged by the user to release the collection container (16), the release tab (84) prevents any accidental release of the collection container (16) from the blood collection attachment (82). In one embodiment, the release tab (84) may have a bright color or pattern that visually indicates to the user that the release tab (84) must be pressed to release the collection container (16) from the blood collection attachment (82). In one embodiment, the release tab (84) acts as a “lever” for unlocking the collection container detachment member (80). In one embodiment of the present disclosure, the blood collection attachment (82) may seal the sealing surface (106) of the lid (86) from contamination until the collection container (16) is removed and the lid (86) is closed over the collection container (16). In one embodiment of the present disclosure, the latching function of the lid (86) may be blocked by the blood collection attachment (82) to provide a tamper-proof function that identifies tampering with the lid (86).

[0090] As shown in Figures 7 and 9-13, according to one embodiment of the present disclosure, the lid (86) of the collection container (16) may be positioned against an outward projection (88) extending outward from the outer surface of the collection container (16). The lid (86) may have soft rubber, such as material (TPE), which releases the collection container (16), acts as a spring-loaded locking mechanism, and creates resistance when pressed by the user. A release tab (84) may be formed as a projection on the lid (86). The lid (86) may be connected to the collection container (16) using a living hinge (90). The lid (86) may have a pre-existing force that causes the lid (86) to tilt slightly. In one embodiment, the lid (86) may be pre-loaded by 50% to 75%. When the lid (86) is pre-loaded, the living hinge (90) may act as a spring, as shown in Figure 8. The outer portion of the living hinge (90) may be extended, while the inner portion of the living hinge (90) may be compressed. The prepressure on the lid (86) assists in holding the collection container (16) in active locking engagement with the blood collection attachment (82).

[0091] Referring to Figures 3 and 14, when the user pushes the edge of the lid (86) in direction A, the lid (86) may tilt further. The lid (86) may be positioned so as to be conspicuous or detached from the collection container (16) even after the user has pushed the release tab (84) toward the collection container (16). As shown in Figure 14, in one embodiment of the present disclosure, the lid (86) may have a recess (92) positioned to engage with a protrusion (94) extending from the blood collection attachment (82). When the collection container (16) is inserted into the blood collection attachment (82), the lid (86) is pressed against the protrusion (94) until the protrusion (94) is actively locked into the recess (92) formed in the lid (86) of the collection container (16). The recess (92) and the corresponding surfaces on the protrusion (94) are positioned to actively engage with each other so as to maintain the lid (86) in the open position until released by the release tab (84). Once the first collection container (16) is filled with blood sample (18), the first collection container (16) may be easily removed from the blood collection attachment (82), and the second collection container (16) may be inserted into the blood collection attachment (82) to receive an additional amount of blood sample (18).

[0092] Referring to Figures 15-17, according to various embodiments of this disclosure, the fold line and stiffness of the living hinge (90) can be adjusted by adding or removing material from the living hinge (90). In Figure 15, the thickness T of the living hinge (90) may be reduced to adjust the fold line and stiffness of the living hinge (90). In Figure 16, a cutout or slot (96) may be made in the living hinge (90) to reduce the width W of the living hinge (90). In Figure 17, a cutout or slot (96) may be cut in the living hinge (90) to reduce the amount of material used in the living hinge (90). It is understood that other parts of the living hinge (90) may be used to control the fold line and stiffness of the living hinge (90) by adding or removing material.

[0093] Referring to Figure 18, in one embodiment of the present disclosure, the lid (86) of the collection container (16) may be provided with at least one guide tab (98) so that the lid (86) is precisely positioned on the collection container (16) when the lid (86) is closed. In one embodiment of the present disclosure, the collection container (16) may be provided with two guide tabs (98), one of which is positioned on each side of the lid (86) to engage with the side of the collection container (16).

[0094] Referring to Figure 19, in one embodiment of the present disclosure, the collection container (16) and the blood collection attachment (82) may have an alignment function to ensure that the collection container (16) is properly aligned when it is received in the blood collection attachment (82). In one embodiment, the collection container (16) may have an alignment projection (100) protruding from the outer surface of the collection container (16). A corresponding alignment slot (102) may be defined in the inner surface of the blood collection attachment (82) to receive the alignment projection (100). It is considered that the blood collection attachment (82) may have an alignment projection (100), and the collection container (16) may have an alignment slot (102). In some embodiments of the present disclosure, the collection container (16) may have one or more alignment projections (100), while the blood collection attachment (82) may have one or more alignment slots (102). In one embodiment, the number of alignment protrusions (100) provided on the collection container (16) is the same as the number of alignment slots (102) provided on the blood collection attachment (82).

[0095] Referring to Figure 20, in one embodiment of the present disclosure, the blood collection attachment (82) may have additional features for guiding the collection container (16) into a desired position when it is inserted into the blood collection attachment (82). The side walls (104) of the blood collection attachment (82) may be positioned as inclined to guide the collection container (16) to actively engage with the blood collection attachment (82) and to hold the collection container (16) in a stable position within the blood collection attachment (82).

[0096] Referring to Figure 13, in one embodiment of the present disclosure, the removed recess (108) may be defined in the outer surface of the blood collection attachment (82) to help improve the user's grip on the blood collection attachment (82). The removed recess (108) may be located opposite the release tab (84) pressed by the user's thumb. Referring to Figure 9, in one embodiment of the present disclosure, the recessed recess (110) may be defined in the outer surface of the blood collection attachment (82) at the location on the release tab (84). The recess (110) may provide a further touch point for the release tab (84) away from the surface of the blood collection attachment (82). The recess (110) also provides a visible “landing pad” for the user’s thumb when operating the blood collection attachment (82). The recessed surface of the recess (110) may be heavily textured to reduce the background function of the blood collection attachment (82).

[0097] Referring to Figures 21 and 22, in one embodiment of the present disclosure, the holder (12) may include a rotatable coupling assembly (112) coupled to a blood collection attachment (82), allowing the user to rotate the blood collection attachment (82) and collection container (16) on the holder (12) away from and toward the port (26). The rotatable coupling assembly (112) may include a socket and a post member that actively engages via a friction fit to allow rotation of the blood collection attachment (82) and collection container (16). The socket and post member may be provided on either the holder (12) or the blood collection attachment (82), respectively. The friction fit for the rotatable coupling assembly (112) is strong enough to support the force generated from the collection container (16) when the collection container (16) is held in an inactive position, so as not to interfere with the collection container (16) when puncturing the patient's finger (19). Furthermore, the friction fit for the rotatable coupling assembly (112) is strong enough for the user to manually rotate the collection container (16) to an active position. The collection container (16) is not capable of moving to an active position by its own weight.

[0098] As shown in Figure 22, in one embodiment of the present disclosure, the rotatable coupling assembly (112) comprises friction bearing surfaces (114) that create a friction fit in order to maintain the collection container (16) in an inert state. In one embodiment, the coefficient of friction between the friction bearing surfaces (114) is 0.15 to 0.2. As shown in Figure 23, in another embodiment of the present disclosure, the rotatable coupling assembly (112) may comprise retaining projections (116) that prevent the rotatable coupling assembly (112) from rotating until sufficient force is applied.

[0099] Embodiments of the capillary blood collection device are shown in the accompanying drawings and described in detail above, but to those skilled in the art, other embodiments are obvious and readily compose without departing from the scope and spirit of the invention. Therefore, the above description is intended to be illustrative rather than restrictive. The invention described above is defined by the accompanying claims, and all modifications to the invention that fall within the equivalent meaning and scope of the claims are encompassed therein.

Claims

1. A holder for receiving a sample source, having an operating part and a port, A blood collection attachment is detachably connected to the holder, The system comprises a collection container detachably connected to the blood collection attachment, which defines the collection space, A device for acquiring a blood sample, wherein a release tab is provided between the blood collection attachment and the collection container, configured to push the collection container away from the blood collection attachment.

2. The device according to claim 1, wherein the collection container is provided with a lid, and the lid is provided with an elastomer that acts as a spring-loaded locking mechanism to create resistance with the collection container.

3. The device according to claim 2, wherein the lid is connected to the collection container via a living hinge.

4. The device according to claim 3, wherein the living hinge has reduced thickness or has at least one cutout.

5. The device according to claim 2, wherein the release tab has a protrusion, and the lid defines a recess for receiving the protrusion to lock the collection container onto the release tab.

6. The device according to claim 2, wherein the lid is provided with at least one guide tab to ensure that the lid is in a desired position on the collection container when the lid is closed.

7. The device according to claim 1, wherein the collection container comprises aligned protrusions extending from the outer surface of the collection container, and the blood collection attachment defines aligned slots on the inner surface of the blood collection attachment to position the collection container in a desired position when inserted into the blood collection attachment.

8. The device according to claim 1, wherein a rotatable coupling assembly is provided between the holder and the blood collection attachment.

9. The device according to claim 8, wherein the rotatable coupling assembly is arranged such that the collection container rotates relative to the holder between a filled position and a storage position.

10. The device according to claim 9, comprising a rotatable coupling assembly and a post member held together via a friction fit.

11. Blood collection attachment, The system comprises a collection container detachably connected to the blood collection attachment, which defines the collection space, A release tab is provided between the blood collection attachment and the collection container, configured to push the collection container away from the blood collection attachment. A device for obtaining blood samples.

12. The device according to claim 11, wherein the collection container is provided with a lid, and the lid is provided with an elastomer that acts as a spring-loaded locking mechanism to create resistance with the collection container.

13. The device according to claim 12, wherein the lid is connected to the collection container via a living hinge.

14. The device according to claim 13, wherein the living hinge has reduced thickness or has at least one cutout.

15. The device according to claim 12, wherein the release tab has a protrusion, and the lid defines a recess for receiving the protrusion to lock the collection container onto the release tab.

16. The device according to claim 12, wherein the lid is provided with at least one guide tab to ensure that the lid is in a desired position on the collection container when the lid is closed.

17. The device according to claim 11, wherein the collection container comprises aligned protrusions extending from the outer surface of the collection container, and the blood collection attachment defines aligned slots on the inner surface of the blood collection attachment to position the collection container in a desired location when inserted into the blood collection attachment.

18. The device according to claim 11, wherein a rotatable coupling assembly is provided between the holder and the blood collection attachment.

19. The device according to claim 18, wherein the rotatable coupling assembly is configured such that the collection container rotates between a filled position and a storage position relative to the holder.

20. The device according to claim 19, wherein the rotatable coupling assembly comprises a socket and a post member held together via a friction fit.

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