Blood sampling device with front-end automation feature

Abstract

A collection container for holding a blood sample, the collection container comprising a tube defining a collection lumen, a cap disposed on one end of the collection lumen, and a cover member for covering at least a portion of a side surface of the collection container proximate the cap, where the cover member is configured to cover a peripheral surface of the collection container, a uniform smooth surface is created around the circumference of the collection container.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 344,381, filed on May 20, 2022, and entitled “Blood Collection Device with Front-End Automation Features,” the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present disclosure generally relates to a device for obtaining a biological sample. More specifically, the present disclosure relates to an integrated finger-based capillary blood collection device having the ability to pierce and squeeze a finger, collect a blood sample, stabilize the blood sample, and dispense the blood sample in a controlled manner.

[0006] Description of Related Technology

[0007] Devices for obtaining and collecting biological samples (such as blood samples) are commonly used in the medical industry. One type of blood sampling commonly used in the medical field is capillary blood sampling, which is commonly used to collect blood samples for testing. Certain diseases (such as diabetes) require regular testing of the patient's blood to monitor, for example, the patient's blood sugar level. In addition, test kits (such as cholesterol test kits) generally require analysis of blood samples. The blood sampling procedure generally involves pricking a finger or other appropriate body part to obtain a blood sample. Generally, the amount of blood required for such a test is relatively small, and a small puncture wound or incision can usually provide enough blood for these tests. Various types of lancet devices have been developed, which are used to pierce the patient's skin to obtain capillary blood samples from the patient.

[0008] Many different types of lancet devices are commercially available for use in hospitals, clinics, doctors' offices, etc., as well as by individual consumers. Such devices typically include a pointed member (such as a needle) or a sharp-edged member (such as a blade) that is used to quickly create a puncture wound or incision in the patient's skin to provide a small amount of blood to flow out. In order to simplify capillary blood sampling, lancet devices have evolved into automated devices that can pierce or incise the patient's skin once a trigger mechanism is activated. In some devices, the needle or blade remains in a standby position until it is triggered by the user. Once triggered, the needle or blade will pierce or incise the patient's skin, such as the skin on a finger. Typically, a spring is incorporated into the device to provide the "automatic" force required to pierce or incise the patient's skin.

[0009] A contact-activated puncture device characterized by automatically ejecting and retracting a piercing or cutting element is U.S. Patent No. 9,380,975 owned by Becton, Dickinson and Company, the assignee of the present application. The puncture device includes a housing and a puncture structure having a puncture element. The puncture structure is disposed in the housing and is adapted to move between a retaining position or a pre-actuation position and a puncture position, in which the puncture element is retained in the housing and in which the puncture element extends through a front end of the housing. The puncture device includes a drive spring and a retaining hub, the drive spring being disposed in the housing for biasing the puncture structure toward the puncture position, the retaining hub retaining the puncture structure in a retracted position against the bias of the drive spring. The retaining hub includes a pivot rod that is in interference engagement with the puncture structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rear end of the housing to at least partially compress the drive spring and release the interference engagement of the lever with the lancet structure. The received blood sample is then collected and / or tested. Such testing can be performed by a Point-of-Care (POC) testing device, or can be collected and sent to a testing agency.

[0010] The use of lancet devices for capillary blood sampling can be complex and require a high level of skill for the healthcare provider performing the blood sampling procedure. The multi-step nature of the capillary blood sampling process can introduce several variables that can lead to sample quality issues such as hemolysis, insufficient sample stability, and microclotting. Using a lancet device to obtain a blood sample can result in several variables that affect the collection of a capillary blood sample, including, but not limited to: keeping the lancet stationary during the test, obtaining adequate blood flow from the puncture site, adequately collecting blood, preventing coagulation, etc. Some of the most common sources of process variability are: (1) inadequate puncture site cleaning and first drop removal, which can potentially lead to sample contamination; (2) inconsistent puncture location and depth, which can potentially lead to insufficient sample volume and a large portion of interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the puncture site to facilitate blood extraction (e.g., blood squeezing), which can potentially lead to sample hemolysis; (4) variable transfer interface and collection technique, which can lead to sample hemolysis or contamination; and (5) inadequate mixing of the sample with the anticoagulant, which can potentially lead to microclotting.

[0011] During assembly and / or use of the blood collection device, a robotic arm may be used to pick up the blood collection device and place it in a desired location. Problems associated with the pick and place robotic arm may arise due to features on the blood collection device, including a protruding latch on the cap, a protruding living hinge on the cap, and / or a protruding U-shaped rib for removing the cap. Therefore, there is a need in the art for a blood collection device including a front end feature to improve the automated movement of the blood collection device and the securing of the blood collection device to a pair of robotic arms. Summary of the invention

[0012] According to one aspect of the present disclosure, a collection container for holding a blood sample may include: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, and the side wall defining an outer surface; a cover capable of being detachably engaged with the open end of the tube; and a covering member for covering at least a portion of the outer surface of the tube near the cover, wherein the covering member is configured to circumferentially cover at least a portion of the outer surface of the collection container to produce a uniform smooth surface around the circumference of the collection container.

[0013] According to one aspect of the present disclosure, the cover may include a release tab that, when pressed, releases the collection container from the blood collection device attachment. The cover may be connected to the collection container via a living hinge. The covering member may be integrally formed with the collection container. The covering member may include a colorant to identify the covering member. The colorant may be yellow. The diameter of the cover may be greater than the diameter of the tube. The extension portion may be removably attached to the bottom end of the tube.

[0014] According to one aspect of the present disclosure, a collection container for holding a blood sample may include: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, the side wall defining an outer surface; a cover capable of being removably engaged with the open end of the tube; and a plurality of axial ribs configured to cover at least a portion of the outer surface of the tube near the cover, wherein the plurality of axial ribs are configured to circumferentially cover at least a portion of the outer surface to produce a more uniform, band-like, smooth surface around the circumference of the collection container.

[0015] According to one aspect of the present disclosure, the cover may include a release tab that releases the collection container from the blood collection device attachment when the release tab is pressed. The cover may be connected to the collection container via a living hinge. The plurality of axial ribs may be integrally formed with the collection container. The plurality of axial ribs may include a colorant to identify the plurality of axial ribs. The colorant may be yellow. The diameter of the cover may be greater than the diameter of the tube. The extension portion may be removably attached to the bottom end of the tube.

[0016] According to one aspect of the present disclosure, a collection container for holding a blood sample may include: a tube having an open end, a closed bottom end, and a sidewall extending between the open end and the closed bottom end, the tube defining a collection cavity, the sidewall defining an outer side surface; a cover removably engageable with the open end of the tube; and an extension removably engageable with a portion of the tube such that the extension extends over the closed bottom end and is configured to increase the overall length of the tube. The extension may be removably engageable with the tube via a friction fit, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic weld connection.

[0017] According to one aspect of the present disclosure, a collection container for holding a blood sample may include: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, and the side wall defining an outer surface; a cover capable of being detachably engaged with the open end of the tube; a covering member, the covering member being used to cover at least a portion of the outer surface of the tube near the cover; and a plurality of ribs positioned on the covering member and configured to cover at least a portion of the covering member, wherein the covering member and the plurality of ribs are configured to circumferentially cover at least a portion of the outer surface to produce a more uniform, band-like, smooth surface around the circumference of the collection container.

[0018] The present invention is further defined in the following terms:

[0019] Article 1: A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, the side wall defining an outer surface; a cover capable of being removably engaged with the open end of the tube; and a covering member for covering at least a portion of the outer surface of the tube adjacent to the cover, wherein the covering member is configured to circumferentially cover at least a portion of the outer surface of the collection container to produce a uniform smooth surface around the circumference of the collection container.

[0020] Item 2: The collection container of Item 1, wherein the cap includes a release tab that releases the collection container from the lancing device attachment when the release tab is pressed.

[0021] Clause 3: The collection container of clause 1 or clause 2, wherein the lid is connected to the collection container via a living hinge.

[0022] Article 4: The collection container according to any one of Articles 1 to 3, wherein the covering member is formed integrally with the collection container.

[0023] Clause 5: The collection container according to any one of Clauses 1 to 4, wherein the covering member includes a colorant to identify the covering member.

[0024] Article 6: The collection container according to Article 5, wherein the colorant is yellow.

[0025] Clause 7: A collection container according to any one of Clauses 1 to 6, wherein the diameter of the cap is greater than the diameter of the tube.

[0026] Clause 8: The collection container according to any one of Clauses 1 to 7, further comprising an extension portion that is removably attached to the bottom end of the tube.

[0027] Article 9: A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, the side wall defining an outer surface; a cover capable of being removably engaged with the open end of the tube; and a plurality of axial ribs configured to cover at least a portion of the outer surface of the tube near the cover, wherein the plurality of axial ribs are configured to circumferentially cover at least a portion of the outer surface to produce a more uniform, band-like, smooth surface around the circumference of the collection container.

[0028] Clause 10: The collection container of clause 9, wherein the cap comprises a release tab that releases the collection container from the lancing device attachment when the release tab is pressed.

[0029] Clause 11: The collection container of clause 9 or clause 10, wherein the lid is connected to the collection container via a living hinge.

[0030] Clause 12: The collection container of any one of Clauses 9 to 11, wherein the plurality of axial ribs are integrally formed with the collection container.

[0031] Clause 13: The collection container of any one of Clauses 9 to 12, wherein the plurality of axial ribs include a colorant to identify the plurality of axial ribs.

[0032] Article 14: The collection container according to Article 13, wherein the colorant is yellow.

[0033] Article 15: A collection container according to any one of Articles 9 to 14, wherein the diameter of the cap is greater than the diameter of the tube.

[0034] Clause 16: The collection container according to any one of Clauses 9 to 15, further comprising an extension portion detachably attached to the bottom end of the tube.

[0035] Article 17: A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, the side wall defining an outer surface; a cover that is removably engageable with the open end of the tube; and an extension portion that is removably engageable with a portion of the tube so that the extension portion extends over the closed bottom end, and the extension portion is configured to increase the overall length of the tube.

[0036] Clause 18: The collection container of Clause 17, wherein the extension portion is removably engageable with the tube via a friction fit, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic weld connection.

[0037] Article 19: A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a side wall extending between the open end and the closed bottom end, the tube defining a collection chamber, the side wall defining an outer surface; a cover capable of being removably engaged with the open end of the tube; a covering member, the covering member being used to cover at least a portion of the outer surface of the tube adjacent to the cover; and a plurality of ribs positioned on the covering member and configured to cover at least a portion of the covering member, wherein the covering member and the plurality of ribs are configured to circumferentially cover at least a portion of the outer surface to produce a more uniform, band-like, smooth surface around the circumference of the collection container. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a perspective view of a holder according to an embodiment of the present invention.

[0039] Figure 2A is a cross-sectional view of a device for obtaining a blood sample from a patient's finger and a lancet according to another embodiment of the present disclosure.

[0040] Figure 2B is a perspective view of a device for obtaining a blood sample from a patient's finger and a sample collection container according to another embodiment of the present disclosure.

[0041] Figure 3 is a side view of a device for obtaining a blood sample from a patient's finger and a collection container according to another embodiment of the present disclosure.

[0042] Figure 4 It is a three-dimensional view of the unlocked collection container detachable component.

[0043] Figure 5 It is in detached state Figure 4 A stereoscopic image of a collection container.

[0044] Figure 6 It is in detached state Figure 4 Another stereoscopic view of the collection container.

[0045] Figure 7 is a perspective view of a collection container with a cover according to an aspect of the present disclosure.

[0046] Figure 8 is a perspective view of a collection container with ribs according to an aspect of the present disclosure.

[0047] Fig. 9A Colorants are added Figure 7 A three-dimensional view of a collection container and a cover.

[0048] Fig. 9B Colorants are added Figure 7 A three-dimensional view of a collection container and a cover.

[0049] Fig. 10A Colorants are added Figure 8 A three-dimensional view of the collection container and ribs.

[0050] Fig. 10B Colorants are added Figure 8 A three-dimensional view of the collection container and ribs.

[0051] Fig.11 is a perspective view of a collection container with an extended portion according to an aspect of the present disclosure.

[0052] Fig.12 yes Fig.11 A cross-sectional view of a collection container.

[0053] Fig.13 is a cross-sectional view of a collection container according to one aspect of the present disclosure, wherein the diameter of the cap is greater than the diameter of the tube of the collection container.

[0054] Fig.14 is an assembled view of a collection container having ribs and extensions according to one aspect of the present disclosure. DETAILED DESCRIPTION

[0055] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0056] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may employ alternative variations and step sequences unless expressly stated to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0057] The present disclosure relates to a device for obtaining a biological sample, such as a capillary blood sampling device, which meets the above needs and has the ability to pierce and squeeze a finger, collect a sample, stabilize the sample, and then dispense the sample in a controlled manner. The device also simplifies and streamlines capillary blood sampling by eliminating the workflow variability typically associated with poor sample quality, including hemolysis and microclotting.

[0058] Blood collection is fundamentally driven by pressure-driven flow. Devices or techniques either reduce the pressure outside the vessel (vacuum-powered flow) or increase the pressure inside the vessel. Both approaches increase the difference between the vessel pressure and the external pressure and increase the flow rate from inside the vessel to the outside where the collection container is located. The location of the compression can also be critical because soft tissues (e.g., fat, skin, and muscle tissue) are filled with blood, while hard tissues and joints are less filled with blood or too mechanically stable to be compressed without causing pain to the patient.

[0059] Red Blood Cells (RBCs) can hemolyze during collection. Hemolysis (RBC destruction) contaminates samples for diagnostic analysis both by spilling cellular contents into the liquid serum of the sample and by staining the serum red via hemoglobin and interfering with colorimetric reactions. The amount of hemolysis during collection is caused by shear-mediated destruction of the cells due to flow rate and flow path, as well as pressure-induced hemolysis, where physical compression of tissues and blood vessels can damage cells. Therefore, hemolysis can be controlled by ensuring that the applied pressure and flow are not too high at any point in the squeezed finger.

[0060] The present disclosure includes a self-contained, fully integrated finger-based capillary blood sampling device having the ability to puncture, collect and stabilize high volume (e.g., up to or above 500 microliters) capillary blood samples. The device simplifies and streamlines high volume capillary blood sampling by eliminating workflow steps and variability typically associated with poor sample quality, including hemolysis, microclotting, and patient discomfort. The device includes a retractable lancet mechanism that can puncture a finger and an associated blood flow path, which ensures attachment and transfer of capillary blood from the punctured finger site to a collection container. The device also includes a retainer that can be cyclically squeezed to promote (i.e., pump) blood flow from the finger, and the device also includes an anticoagulant that is deposited in the flow path or collection container to stabilize the collected sample.

[0061] According to one design, the device can include discrete components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into a device that is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are contemplated for use as a self-contained disposable device and / or in conjunction with an external power source for pain relief control. The capillary blood collection device can be used as a platform for a variety of capillary collection containers, ranging from small tubes to capillary dispensers and onboard plasma separation modules. This capability extends product flexibility to a variety of applications, including dispensing into point-of-care (POC) boxes or small collection tube transfers that can be used in centrifuges or analytical instruments.

[0062] refer to Figure 1 and Figure 2A In an exemplary embodiment, the device 10 of the present disclosure includes discrete components, such as a retainer 12 (eg, Figure 1 As shown), the needle housing or the needle 14 (as shown Figure 2A As shown) and collection container 16 (as Figure 2B ). In another exemplary embodiment, a semi-integrated device of the present disclosure may include an at-angle flow and include an integrated lancet housing and a collection container, which may be connected to a separate holder. In another exemplary embodiment, a semi-integrated device of the present disclosure may have an in-line flow and include an integrated lancet housing and a collection container, which may be connected to a separate holder. In another exemplary embodiment, an integrated device of the present disclosure may have an angled flow and include an integrated holder, a lancet housing, and a collection container. In another exemplary embodiment, an integrated device of the present disclosure may have an in-line flow and include an integrated holder, a lancet housing, and a collection container.

[0063] refer to Figure 1 , which illustrates and describes an exemplary embodiment of a holder 12 of the present disclosure, which is capable of receiving a sample source (such as a finger 19) for supplying a biological sample (such as a blood sample 18). The holder 12 of the present disclosure generally includes a finger receiving portion 20 ( Figure 1 ), an actuation portion 24, a port 26 having a second opening 28, and a fingertip guard 30. In one embodiment, the fingertip guard 30 provides a stop for properly aligning and securing the finger 19 within the holder 12. The fingertip guard 30 also helps ensure that the patient's finger 19 is properly positioned within the finger receiving portion 20 so that pressure applied to the patient's finger 19 will generate adequate blood flow.

[0064] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source (such as a finger 19) for supplying a biological sample (such as a blood sample 18). It will be appreciated that the sample source may include other parts of the body that can fit within the first opening 22. The port 26 is in communication with the finger receiving portion 20. For example, in the case where the finger 19 is received in the holder 12, the port 26 is in communication with a portion of the finger 19. The holder 12 of the present disclosure can be sized to accommodate all finger sizes.

[0065] The second opening 28 of the port 26 is configured to receive the lancet housing 14 and the collection container 16 , as described in more detail below. In one embodiment, the port 26 includes a locking portion 32 for securely receiving the lancet housing 14 and the collection container 16 within the port 26 .

[0066] In one embodiment, the actuating portion 24 is transitionable 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, wherein the second diameter is less than the first diameter. In one embodiment, the actuating portion 24 is transitionable between a first position in which the holder 12 defines a first elliptical shape and a second position in which the holder 12 defines a second elliptical shape, wherein the first elliptical shape is different from the second elliptical shape. In this manner, with the holder 12 in the second position with a reduced diameter, a portion of the holder 12 contacts the sample source and the actuating portion 24 of the holder 12 is able to aspirate and / or extract blood 18, as described in more detail below.

[0067] refer to Figure 1 In one embodiment, the actuation portion 24 includes a contact member 34. When the actuation portion 24 is in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is disposed in the first position relative to the sample source (e.g., the finger 19) so that the contact member 34 can slightly contact the sample source. When the actuation portion 24 is in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is disposed in the second position relative to the sample source (e.g., the finger 19) so that the contact member 34 is in an applied pressure contact with the finger 19 and the actuation portion 24 of the holder 12 is able to aspirate and / or extract the blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0068] refer to Figure 1In one embodiment, the actuation portion 24 includes a suction member 36 for applying pressure to a sample source (e.g., a finger 19). In one embodiment, the suction member 36 includes a pair of opposing lugs or wings 38. In such an embodiment, each lug 38 may include a contact member 34. In one embodiment, the holder 12 includes a living hinge portion 42. The living hinge portion 42 allows a user to squeeze the wing 38 between a first position (passive state) and a second position (active state). Using the lugs or wings 38 to draw blood 18 from the patient's finger 19 minimizes hemolysis while maintaining adequate blood flow from the patient's finger 19. The static position and articulation of the wing 38 are designed to maintain contact and retention with the smallest patient finger that can fit in the holder 12, while bending to accommodate the largest patient finger within the holder 12 without blood occlusion.

[0069] Advantageously, the holder 12 of the present disclosure allows a user to repeatedly squeeze and release the wings 38 to aspirate and / or extract blood 18 from the finger 19 until a desired amount of blood 18 is filled into the collection container 16. The wings 38 are configured to flex to maintain gentle contact with a patient's finger of a range of sizes that can be used with the holder 12 and to secure the holder 12 to the patient's finger 19.

[0070] Advantageously, the holder 12 does not restrict blood flow and defines a puncture location and a finger compression location when the holder 12 is placed on the finger 19. The compression tabs or wings 38 provide a predefined range of compression pressures that are applied consistently across the finger 19. By doing so, the holder 12 provides a gentle, controlled finger massage that promotes blood extraction and minimizes any potential hemolysis.

[0071] refer to Figure 1 In one embodiment, the holder 12 includes a stability extension 40. The stability extension provides additional support for the holder 12 to securely place the holder on the finger 19. In one embodiment, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of internal gripping members that are used to provide additional grip and support for the holder 12 to securely place the holder on the finger 19. The stability 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.

[0072] In one embodiment, the finger receiving portion 20 is formed of a flexible material. In some embodiments, the finger receiving portion 20 and the port 26 are formed of a flexible material.

[0073] The disclosed device 10 for obtaining a blood sample 18 includes a lancet housing or lancet 14 that is removably connectable to the port 26 of the holder 12. In one embodiment, the lancet housing 14 includes an entrance or opening 50, an interior 52, a piercing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the piercing element 54 is movable between a pre-actuated position, in which the piercing element 54 is retained within the interior 52 of the lancet housing 14, and a piercing position, in which at least a portion of the piercing element 54 extends through the entrance 50 of the lancet housing 14 to pierce a portion of the finger 19.

[0074] In one embodiment, the lancet 14 of the present disclosure is a contact-activated lancet and can be constructed according to the features disclosed in U.S. patent application 2006 / 0052809, filed on May 6, 2005, entitled "Contact Activated Lancet Device," which is commonly assigned with the present application, and the entire disclosure of which is expressly incorporated herein by reference.

[0075] In one embodiment, the lancet housing 14 can 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 can be removably 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.

[0076] refer to Figure 2A In one embodiment, where the holder 12 and the lancet housing 14 are separate components, the lancet housing 14 can be removably connected to the port 26 of the holder 12. In such an embodiment, the lancet housing 14 includes an engagement portion 56. Figure 2A In one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12 such that the piercing element 54 of the lancet housing 14 can be activated to pierce or pierce a sample source (e.g., a finger 19). In some embodiments, the port 26 of the holder 12 includes a plurality of ribs that are used to secure and lock the lancet 14 or collection container 16 in the port 26.

[0077] To activate the lancet 14, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the lancet 14 to puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and predefined puncture location, thereby ensuring sufficient sample volume.

[0078] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the piercing element 54 toward the piercing position. After piercing, the piercing element 54 is immediately retracted and securely fixed within the interior 52 of the lancet housing 14.

[0079] In one embodiment, the lancet 14 of the present disclosure is used to pierce the skin of a finger 19 and then a blood sample 18 is squeezed into a collection container 16, as described in more detail below.

[0080] In one embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along a puncture path, and the blood sample 18 then flows down a blood flow path at an angle to the puncture path, as described in more detail below.

[0081] In one embodiment, the lancet 14 may include a hollow needle. In such an embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along a puncture path, and then the blood sample 18 (such as Figure 2B As shown) flows through the hollow needle along a parallel blood flow path.

[0082] like Figure 2B As shown, the device 10 for obtaining a blood sample 18 of the present disclosure includes a collection container 16 that can be removably connected to the port 26 of the holder 12. In one configuration, the collection container 16 can be a collection container of any size, such as a microtube that can be adapted to fit within the outer shape of a 13×75 mm, 13×100 mm, or 16×100 mm standard tube collection container. The collection container 16 defines a collection chamber 70 for receiving the blood sample 18, a container engagement portion 72, a lancet portion 74, and a cap or septum 76. Once the desired amount of blood 18 is collected in the container 16, the lancet portion 74 is detached from the collection device 10 to deliver the collected sample 18 to a diagnostic instrument and / or testing device. Once the lancet portion 74 is removed from the collection device 10, it is sealed via the cap or septum 76 to protectively seal the blood sample 18 within the collection chamber 70.

[0083] In one embodiment, the collection container 16 can 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 can be removably 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.

[0084] In one embodiment, where the holder 12 and the collection container 16 are separate components, the container 16 can be removably connected to the port 26 of the holder 12. In such an embodiment, the container 16 includes a container engagement portion 72. In one embodiment, the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked within the locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12 so that the blood sample 18 can safely flow from the finger 19 in the holder 12 to the collection chamber 70 of the container 16.

[0085] It will be appreciated that several types of collection containers 16 may be used with the apparatus 10 of the present disclosure. It will also be appreciated that the collection container 16 may be associated with a separate dispensing unit, or the collection container 16 may include an integrated dispensing portion for dispensing blood 18 to a testing device. The collection container 16 may be a stand-alone container, or may also include a false bottom to allow the instrument to be compatible with conventional larger volume collection containers. Optionally, the bottom of the collection container 16 may be hemispherical or include a partially rounded portion.

[0086] refer to Figure 1 , the use of the device 10 of the present disclosure having discrete components, such as a retainer 12, a lancet housing or lancet 14, and a collection container 16 will now be described.

[0087] refer to Figure 1 , first clean the desired finger 19, select a holder 12 having a size suitable for the desired finger 19, and place the holder securely on the finger 19. Next, refer to Figure 2A , connect the lancet housing 14 to the port 26 of the holder 12. As described above, the lancet housing 14 is pushed into the port 26 of the holder 12 so that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this way, the lancet housing 14 is securely connected and locked to the holder 12 so that the piercing element 54 ( Figure 2A ) can be activated to puncture or pierce a sample source (eg, finger 19). With the lancet 14 connected to the port 26 of the holder 12, the lancet 14 is in communication with the finger 19.

[0088] When it is desired to activate the lancet 14 to puncture the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 ( Figure 2A ) to puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and predefined puncture location, thereby ensuring sufficient sample volume.

[0089] After pricking the finger 19 to allow blood 18 to 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. Figure 2B , the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked in the locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12 so that the blood sample 18 can safely flow from the finger 19 in the holder 12 to the collection chamber 70 of the container 16.

[0090] refer to Figure 1 , with the container 16 properly secured to the holder 12 to collect a blood sample 18, the user can repeatedly squeeze and release the wings 38 of the holder 12 to aspirate and / or extract blood 18 from the finger 19 until a desired amount of blood 18 is filled into the collection container 16. Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not restrict blood flow, and defines a puncture location and a finger squeeze location. The squeezing lugs or wings 38 provide a predefined range of squeezing pressures that are applied consistently across the entire finger 19. By doing so, the holder 12 provides a gentle, controlled massage of the finger 19 that facilitates blood extraction and minimizes any potential hemolysis.

[0091] For example, refer to Figure 1 In one embodiment, the actuation portion 24 includes a contact member 34. When the actuation portion 24 is in the first position, the contact member 34 is in the disengaged position, i.e., the contact member 34 is in the first position relative to the sample source (e.g., finger 19). When the actuation portion 24 is in the second position, the contact member 34 is in the engaged position, i.e., the contact member 34 is in the second position and in contact with the sample source (e.g., finger 19) under applied pressure, and the actuation portion 24 of the holder 12 is capable of aspirating and / or extracting blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure to the sample source.

[0092] Once the desired amount of blood 18 is collected in the container 16, the lancet portion 74 is detached from the collection device 10 to transfer the collected sample 18 to a diagnostic instrument and / or testing device. Once the lancet portion 74 is removed from the collection device 10, it is sealed via a cap or septum 76 to protectively seal the blood sample 18 within the collection chamber 70.

[0093] The device disclosed herein can be compatible with any known test device, whether the test device is an over-the-counter test device or a point-of-care test device. Various point-of-care test devices are known in the art. Such point-of-care test devices include test strips, slides, diagnostic boxes, or other test devices for testing and analysis. Test strips, slides, and diagnostic boxes are point-of-care test devices that receive blood samples and test one or more physiological and biochemical states of the blood. There are many point-of-care test devices as follows: These point-of-care test devices use a box-based structure at the bedside to analyze very small amounts of blood without sending the sample to a laboratory for analysis. In the long run, this saves time in obtaining results, but it brings a different set of challenges compared to a highly conventional laboratory environment. Examples of such test boxes include the Abbott group of companies Test kit. Test kit (such as The cassette) can be used to test a variety of conditions, including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation or cardiac markers. Test results using this cassette are quickly provided to clinicians.

[0094] The collection container 16 may also include a sample stabilizer (e.g., an anticoagulant) to stabilize the blood sample 18 and / or components of the blood sample 18 disposed therein. The collection container 16 may also include at least one fill line corresponding to a predetermined volume of the sample. The collection container may also indicate / meter the volume of the collected blood.

[0095] Any of these devices for obtaining blood samples disclosed herein can be used as a self-supporting disposable device and / or in combination with an external power source for pain relief control. For example, a portion of the holder 12 may include an embedded electrode that receives a signal from an external pain control module to transmit at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TEN) for pain relief control. The device for obtaining blood samples disclosed herein may also include various options for onboard plasma separation. The device for obtaining blood samples disclosed herein may also include a unique sample identifier that can be paired with patient information at the time of collection. The device for obtaining blood samples disclosed herein may also include onboard diagnostic feedback at the time of collection. The device for obtaining blood samples disclosed herein may also allow dual collection, for example, using multiple collection ports capable of collecting multiple samples from the same source, collecting two samples into two separate containers, and using different sample stabilizers (such as anticoagulants) to process the samples.

[0096] The device for obtaining a blood sample of the present disclosure significantly simplifies and reduces the technical requirements for large-volume capillary collection from a finger relative to conventional capillary collection using a lancet and capillaries. The device of the present disclosure eliminates blood exposure and prevents device reuse.

[0097] The disclosed device for obtaining a blood sample simplifies, reduces the technical requirements required for, and streamlines the collection process. This is all accomplished through a self-contained closed system device that, when placed on a finger, provides all of the lancing, blood drawing, stabilization, and containment functions in one unit.

[0098] The disclosed apparatus for obtaining a blood sample may be associated with a self-contained unit that provides automated aspiration, controlled finger squeeze, and automated sample labeling and processing.

[0099] refer to Figures 3 to 5 , according to one embodiment of the present disclosure, a collection container detachment member 80 is shown and described in detail. The collection container detachment member 80 can be an intuitive release mechanism that allows a user to press the release member 80 to release the collection container 16 from a blood collection device attachment 82 that is removably connected to the holder 12. The collection container detachment member 80 provides tactile feedback to the user to indicate that the collection container 16 has been removed from the blood collection device attachment 82.

[0100] refer to Figure 6According to one embodiment of the present disclosure, the collection container detachment member 80 may include a release tab 84 that allows a user to disconnect the collection container 16 from the lancet accessory 82. In one embodiment, after the blood sample 18 has been extracted from the patient, the release tab 84 may be pressed inwardly by the user to release the collection container 16 from the lancet accessory 82. Once the release tab 84 is pressed by the user, the collection container 16 may be pulled away from the lancet accessory 82. The release tab 84 may include a latch feature that prevents contamination of the surface that contacts the blood sample 18 in the collection container 16. Since the release tab 84 must be positively 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 lancet accessory 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 lancet accessory 82. In one embodiment, the release tab 84 serves as a "lever" for unlocking the collection container detachment member 80. In one embodiment of the present disclosure, the lancet attachment 82 may also shield the sealing surface of the cover 86 from contamination until the collection container 16 is removed and the cover 86 is closed on the collection container 16. In one embodiment of the present disclosure, the locking feature of the cover 86 may be blocked by the lancet attachment 82 to provide a tamper-proof feature that identifies tampering of the cover 86.

[0101] refer to Figure 7 According to one non-limiting aspect or example of the present disclosure, the blood collection device 10 may also include features that facilitate securing or picking up the blood collection device 10 by an automated machine or device. Since several features of the blood collection device 10 create obstacles or obstructions to the arms of an automated picking machine attempting to pick up the blood collection device 10, a covering member (such as a cover 100) may be provided around the periphery of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The cover 100 may extend around the entire periphery of the top portion of the collection container 16. In one example, the cover 100 may be an over-mold of a rigid plastic or a semi-rigid elastomeric material. The cover 100 is configured to enhance the ability of an arm or clamp of an automated machine or device to grip the collection container 16 for transport or repositioning. The cover 100 may be formed as a single integral piece or as a plurality of pieces connected to one another. The color of the cover may be opaque to aid in identification of the tube. The cover may also provide uniform axial symmetry around the perimeter of at least a portion of the outer surface of the collection container 16, such as at least a portion near the open end.

[0102] refer to Figure 8According to one non-limiting aspect or example of the present disclosure, the blood collection device 10 may include an alternative feature that facilitates securing or picking up the blood collection device 10 by an automated machine or device. In lieu of the cover 100 described above, a plurality of axial ribs 102 may be positioned around the circumference of the top portion of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The plurality of axial ribs 102 may extend around the entire circumference of the collection container 16. The longitudinal axis of each axial rib 102 may extend parallel to the longitudinal axis of the collection container 16. The axial ribs 102 ensure that there are no one or two protruding edges on the collection container 16, but instead include a more uniform smooth surface. The axial ribs 102 are configured to fill in the negative spaces beneath various protrusions on the collection container 16, including the negative spaces beneath the cover latch and the living hinge. The axial ribs 102 may be made of a rigid plastic or a semi-rigid elastic material. The axial ribs 102 may be provided on the collection container 16 during primary molding of the collection container 16 or as overmolded features on the collection container 16. In another example, instead of the axial ribs 102, a plurality of rings may be positioned along the length of the top portion of the collection container 16 to create a more uniform smooth surface that may be more easily gripped by an arm or gripper of an automated pick and place machine or device. The rings may be radial rings extending around the circumference of the top portion of the collection container 16.

[0103] refer to Fig. 9A and Fig. 9B According to one non-limiting aspect or example, the collection container 16 may include additional or alternative features for facilitating the vision system of an automated pick and place machine or device to identify the collection container 16. In some aspects, the vision system may be operated to determine a specific color of the cap of the collection container 16 to ensure that the desired collection container 16 is gripped and / or picked up. This cap color determination is a critical front-end step for the successful automation of a pick and place machine or device. To help ensure that a uniform color is presented to the vision system for optical identification of the collection container type, the cover 100 of the collection container 16 may be formed or manufactured with a colorant to match the surrounding portion of the collection container 16. In some examples, due to the various protruding and angled features of the collection container 16, a uniform color distribution is not achieved on the top portion of the collection container 16. Therefore, by using a colorant for the cover 100, a larger uniform area is presented with the desired colorant to ensure that the vision system can optically identify the colorant in the collection container 16. In one example, the colorant may be molded in the same color as the existing cap of the collection container 16, or molded on a cap of a similar color. In one example, as Fig. 9BAs shown, the entire cover 100 and the entire cap of the collection container 16 can be made of the same colorant. In one example, the cover 100 and the cap can be made of a yellow colorant. The yellow colorant can be pure yellow or different shades or degrees of translucency of yellow. It is also contemplated that colors other than yellow can be used for the cover 100 and the cap. Fig. 10A and 10B As shown, according to one non-limiting embodiment or aspect of the present disclosure, the axial ribs 102 of the collection container 16 may also include a colorant (such as a yellow colorant) to provide a uniform color distribution on the cap of the collection container 16. The color of the axial ribs 102 may match the color of the surrounding cap.

[0104] refer to Fig.11 and Fig.12 According to one non-limiting aspect or example of the present disclosure, additional features may be included on the collection container 16 to facilitate interaction with a pick and place machine or device. In some pick and place machines or devices, the overall tube height of the collection container 16 must be achieved to properly match and interact with the pick and place machine or device. In addition, some pick and place machines or devices require a single wall of plastic on the collection container 16 to accurately assess the liquid level and sample volume in the collection container 16. Fig.11 and Fig.12 As shown, the collection container 16 can be adapted to increase the overall height of the tube while presenting only a single wall of plastic for liquid level sensing in a pick and place machine or device. In one example, an extension 106 can be provided that attaches to the bottom of the collection container 16. The extension 106 can be an adapter that can be connected to any pre-existing collection container. The extension 106 can have an arm 108 for explicitly connecting to the bottom portion of the collection container 16. The arm 108 can be removably attached to the collection container 16 or formed integrally with the collection container. By attaching only the extension 106 to the bottom of the collection container 16, the single wall of plastic of the collection container 16 is maintained for liquid level sensing. The connection between the extension 106 and the collection container 16 forms a uniform surface to create the appearance of a uniform "extended" collection container 16.

[0105] The extension 106 can be included as a permanent feature of the collection container 16 at the time of manufacture, or as an accessory that is attached after collection and before sending to the laboratory for processing. The extension 106 can be secured to the collection container 16 by a friction fit connection, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic welded connection. Alternatively, the collection container 16 can be augmented to create a longer "live bottom", which eliminates the need for a fitting extension component.

[0106] refer to Fig.13According to one non-limiting aspect or example of the present disclosure, additional features may be included on the collection container 16 to facilitate interaction with a pick and place machine or device. In some pick and place machines or devices, the collection container 16 must have a cap having a diameter that is larger than the diameter of the bottom portion of the collection container 16 in order to properly mate and interact with the pick and place machine or device. Because the cap of the collection container 16 has a larger diameter than the diameter of the tube of the collection container 16, the automation process of the pick and place machine or device is improved for determining the orientation of the tube in the pick and place machine or device and performing automatic sorting to obtain the correct orientation. Collection containers 16 that do not include such diameter differences do not allow for automatic differentiation because the components have a uniform outer diameter. As Fig.13 As shown, according to one example, the collection container 16 can include a cap 110 having a diameter D1 that is greater than a diameter D2 of a tube 112 of the collection container 16. The difference in diameter allows for orientation sorting using a pick and place machine or device in an automated workflow. The difference in diameter allows the pick and place machine or device to distinguish between the top of the collection container 16 (cap 110) and the bottom of the collection container 16 (tube 112).

[0107] refer to Fig.14 , according to a non-limiting embodiment or aspect of the present disclosure, a collection container 16 having a combination of a cover 100 and a plurality of axial ribs 102 is shown and described in detail. In some pick and place machines or devices, the overall tube height of the collection container 16 must be achieved to properly match and interact with the pick and place machine or device. In addition, some pick and place machines or devices require a single wall of plastic on the collection container 16 to accurately assess the liquid level and sample volume in the collection container 16. As Fig.14 As shown, the collection container 16 can be adapted to increase the overall height of the tube while presenting only a single wall of plastic for liquid level sensing in a pick and place machine or device. In one example, an extension 106 can be provided that attaches to the bottom of the collection container 16. The extension 106 can be an adapter that can be connected to any pre-existing collection container. The extension 106 can have an arm 108 for explicitly connecting to the bottom portion of the collection container 16. The arm 108 can be removably attached to the collection container 16 or formed integrally with the collection container. By attaching only the extension 106 to the bottom of the collection container 16, the single wall of plastic of the collection container 16 is maintained for liquid level sensing. The connection between the extension 106 and the collection container 16 forms a uniform surface to create the appearance of a uniform "extended" collection container 16.

[0108] Fig.14The collection container 16 shown in the figure can include a covering member (such as a cover 100) that is disposed around the periphery of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The cover 100 can extend around the entire periphery of the top portion of the collection container 16. In one example, the cover 100 can be an overmold of a rigid plastic or a semi-rigid elastic material. The cover 100 is configured to improve the ability of an arm or clamp of an automated machine or device to grip the collection container 16 for transport or repositioning. The cover 100 can be formed as a single integral piece or as multiple pieces connected to each other. The color of the cover can be opaque to aid in identification of the tube. The cover can also provide uniform axial symmetry around the periphery of the outer surface of at least a portion of the collection container 16, such as at least a portion near the open end.

[0109] In addition to the cover 100, the collection container 16 may also include a plurality of axial ribs 102 that may be positioned around the circumference of the top portion of the collection container 16 to create a uniform radial surface for gripping and / or holding the collection container 16 during pick and place automation. The plurality of axial ribs 102 may extend around the entire circumference of the collection container 16. The longitudinal axis of each axial rib 102 may extend parallel to the longitudinal axis of the collection container 16. The axial ribs 102 ensure that there are no one or two protruding edges on the collection container 16, but instead include a more uniform smooth surface. The axial ribs 102 are configured to fill in the negative space under various protrusions on the collection container 16, including the negative space under the lid latch and the living hinge. The axial ribs 102 may be made of a rigid plastic or a semi-rigid elastic material. The axial ribs 102 may be provided on the collection container 16 during the primary molding of the collection container 16, or may be provided as an overmolded feature on the collection container 16. In another example, instead of axial ribs 102, multiple rings can be positioned along the length of the top portion of the collection container 16 to create a more uniform smooth surface that can be more easily gripped by the arms or grippers of an automated pick and place machine or device. The rings can be radial rings that extend around the circumference of the top portion of the collection container 16.

[0110] It is also conceivable that Fig.14 The cover 100 and axial ribs 102 shown may include a combination of 9A to 10B Color differences shown and discussed.

[0111] Although embodiments of the capillary blood sampling device are shown in the drawings and described in detail above, other embodiments will be apparent to and easily made by those skilled in the art without departing from the scope and spirit of the invention. Therefore, the foregoing description is intended to be illustrative rather than restrictive. The invention described above is defined by the appended claims, and all changes to the invention that fall within the equivalent meaning and equivalent range of the claims will be included within the scope of the claims.

Claims

1. A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a sidewall extending between the open end and the closed bottom end, the tube defining a collection cavity, the sidewall defining an outer side surface; a cover removably engageable with the open end of the tube; as well as a covering member for covering at least a portion of the outer side surface of the tube close to the cover, Wherein, the covering member is configured to circumferentially cover at least a portion of the outer side surface of the collection container to create a uniform smooth surface around the circumference of the collection container.

2. The collection container according to claim 1, wherein: The cap includes a release tab that releases the collection container from a lancet attachment when the release tab is depressed.

3. The collection container according to claim 1, wherein: The lid is connected to the collection container via a living hinge.

4. The collection container according to claim 1, wherein: The covering member is formed integrally with the collection container.

5. The collection container according to claim 1, wherein: The covering member includes a colorant to identify the covering member.

6. The collection container according to claim 5, wherein: The colorant is opaque and / or translucent.

7. The collection container according to claim 1, wherein: The cap has a diameter greater than a diameter of the tube.

8. The collection container of claim 1, further comprising an extension portion detachably attached to a bottom end of the tube.

9. A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a sidewall extending between the open end and the closed bottom end, the tube defining a collection cavity, the sidewall defining an outer side surface; a cover removably engageable with the open end of the tube; as well as a plurality of ribs configured to cover at least a portion of the outer side surface of the tube proximate the cover, The plurality of ribs are configured to circumferentially cover at least a portion of the outer surface to create a more uniform, band-shaped, smooth surface around the circumference of the collection container.

10. The collection container according to claim 9, wherein: The plurality of ribs are axially arranged.

11. The collection container according to claim 9, wherein: The cap includes a release tab that releases the collection container from a lancet attachment when the release tab is depressed.

12. The collection container according to claim 9, wherein: The lid is connected to the collection container via a living hinge.

13. The collection container according to claim 9, wherein: The plurality of ribs are integrally formed with the collection container.

14. The collection container according to claim 9, wherein: The plurality of ribs include a colorant to identify the plurality of ribs.

15. The collection container according to claim 14, wherein: The colorant is opaque and / or translucent.

16. The collection container according to claim 9, wherein: The cap has a diameter greater than a diameter of the tube.

17. The collection container of claim 9, further comprising an extension portion removably attached to the bottom end of the tube.

18. A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a sidewall extending between the open end and the closed bottom end, the tube defining a collection cavity, the sidewall defining an outer side surface; a cover removably engageable with the open end of the tube; as well as An extension portion is removably engageable with a portion of the tube such that the extension portion extends over the closed bottom end and is configured to increase the overall length of the tube.

19. The collection container according to claim 18, wherein: The extension portion is removably connected to the tube via a friction fit, an annular snap fit connection, a threaded connection, a bayonet connection, or an ultrasonic weld connection.

20. A collection container for holding a blood sample, the collection container comprising: a tube having an open end, a closed bottom end, and a sidewall extending between the open end and the closed bottom end, the tube defining a collection cavity, the sidewall defining an outer side surface; a cover removably engageable with the open end of the tube; a covering member for covering at least a portion of the outer side surface of the tube close to the cover; as well as a plurality of ribs positioned on the cover member and configured to cover at least a portion of the cover, The cover and the plurality of ribs are configured to circumferentially cover at least a portion of the outer surface to create a more uniform, band-shaped, smooth surface around the circumference of the collection container.

Images